¨
|
|
REGISTRATION
STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE
ACT
OF 1934
|
x
|
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For the fiscal year ended December 31, 2004 |
o
|
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the transition period from
to
|
Title
of each class
|
Name
of each exchange on which registered
|
|
Common
Shares
|
The
American Stock Exchange and
The
Toronto Stock Exchange
|
Yes x
|
No
¨
|
Not
applicable
|
Item
17 ¨
|
Item
18 x
|
Yes
¨
|
No
¨
|
PART
I
|
||||
IDENTITY
OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
|
1
|
|||
OFFER
STATISTICS AND EXPECTED TIMETABLE
|
1
|
|||
KEY
INFORMATION
|
1
|
|||
Currency
and Exchange Rates
|
1
|
|||
Selected
Financial Data
|
1
|
|||
Capitalization
and Indebtedness
|
3
|
|||
Reasons
for the Offer and Use of Proceeds
|
3
|
|||
Risk
Factors
|
3
|
|||
INFORMATION
ON THE CORPORATION
|
8
|
|||
History
and Development of the Corporation
|
8
|
|||
Business
Overview
|
8
|
|||
Organizational
Structure
|
45
|
|||
Property,
Plants and Equipment
|
46
|
|||
OPERATING
AND FINANCIAL REVIEW AND PROSPECTS
|
46
|
|||
Operating
Results
|
46
|
|||
Liquidity
and Capital Resources
|
48
|
|||
Tabular
Disclosure of Contractual Commitments
|
49
|
|||
Research
and Development
|
49
|
|||
Trend
Information
|
51
|
|||
Off-Balance Sheet Arrangements
|
51
|
|||
DIRECTORS,
SENIOR MANAGEMENT AND EMPLOYEES
|
51
|
|||
Directors
and Senior Management
|
51
|
|||
Compensation
|
54
|
|||
Board
Practices
|
57
|
|||
Employees
|
59
|
|||
Share
Ownership
|
59
|
|||
MAJOR
SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
|
61
|
|||
Major
Shareholders
|
61
|
|||
Related
Party Transactions
|
61
|
|||
Interests
of Experts and Counsel
|
61
|
|||
FINANCIAL
INFORMATION
|
61
|
|||
Consolidated
Statements and Other Financial Information (Audited)
|
61
|
|||
Significant
Changes
|
62
|
|||
THE OFFER AND LISTING
|
62
|
|||
Offer
and Listing Details
|
62
|
|||
Plan
of Distribution
|
64
|
|||
Markets
|
64
|
|||
Selling
Shareholders
|
64
|
|||
Dilution
|
64
|
|||
Expenses
of the Issue
|
64
|
ADDITIONAL
INFORMATION
|
65
|
|||
Share
Capital
|
65
|
|||
Memorandum
and Articles of Association
|
65
|
|||
Material
Contracts
|
65
|
|||
Exchange
Controls
|
65
|
|||
Taxation
|
66
|
|||
Dividends
and Paying Agents
|
70
|
|||
Statement
by Experts
|
70
|
|||
Documents
on Display
|
70
|
|||
Subsidiary
Information
|
70
|
|||
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
71
|
|||
Quantitative
and Qualitative Information about Market Risk
|
71
|
|||
DESCRIPTION
OF SECURITIES OTHER THAN EQUITY SECURITIES
|
71
|
|||
PART
II
|
||||
DEFAULTS,
DIVIDEND, ARREARAGES AND DELINQUENCIES
|
71
|
|||
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE
OF
PROCEEDS
|
71
|
|||
CONTROLS
AND PROCEDURES
|
71
|
|||
AUDIT COMMITTEE FINANCIAL EXPERT
|
71
|
|||
CODE
OF ETHICS
|
72
|
|||
PRINCIPAL ACCOUNTANT FEES AND SERVICES
|
72
|
|||
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
|
72
|
|||
PURCHASES
OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED
PURCHASERS
|
72
|
|||
PART III
|
||||
FINANCIAL
STATEMENTS
|
73
|
|||
FINANCIAL
STATEMENTS
|
73
|
|||
EXHIBITS
|
74
|
A.
|
Directors
and Senior Management
|
B.
|
Advisers
|
C.
|
Auditors
|
|
2004
|
2003
|
2002
|
2001
|
2000
|
|||||||||||
Average
|
0.7682
|
.7136
|
.6368
|
.6457
|
.6732
|
|
May-05
|
Apr-05
|
Mar-05
|
Feb-05
|
Jan-05
|
Dec-04
|
|||||||||||||
Low
|
0.7872
|
0.7957
|
0.8024
|
0.7960
|
0.8050
|
0.8064
|
|||||||||||||
High
|
0.8082
|
0.8233
|
0.8321
|
0.8134
|
0.8346
|
0.8434
|
|||||||||||||
Average
|
0.7965
|
0.8091
|
0.8224
|
0.803
|
0.8165
|
0.8204
|
Canadian
GAAP:
|
Fiscal
Year
Ended
December
31,
2004
|
Fiscal
Year
Ended
December
31,
2003
|
Fiscal
Year
Ended
December
31,
2002
|
11-month
Period
Ended
December
31,
2001
|
Fiscal
Year
Ended
January
31,
2001
|
|||||||||||
Operating
Results Product
sales
|
$
|
183,258
|
nil
|
nil
|
nil
|
nil
|
||||||||||
License
revenue
|
$
|
302,080
|
$
|
16,900
|
nil
|
nil
|
nil
|
|||||||||
Investment
tax credits
|
$
|
205,000
|
$
|
223,146
|
$
|
189,908
|
$
|
131,000
|
$
|
115,239
|
||||||
Interest
income
|
$
|
123,626
|
$
|
258,422
|
$
|
257,407
|
$
|
386,580
|
$
|
522,832
|
||||||
Net
loss
|
$
|
5,568,899
|
$
|
4,062,711
|
$
|
4,018,262
|
$
|
3,245,206
|
$
|
1,833,205
|
||||||
Net
loss per share:
|
||||||||||||||||
-
basic and diluted loss
per share
|
$
|
0.26
|
$
|
0.19
|
$
|
0.20
|
$
|
0.17
|
$
|
0.11
|
||||||
Loss
from continuing
operations
per share
|
$
|
0.26
|
$
|
0.19
|
$
|
0.20
|
$
|
0.17
|
$
|
0.11
|
(1)
|
|
In
2001, the Corporation changed its financial year end from January
31 to
December 31.
|
Fiscal
|
Fiscal
|
Fiscal
|
||||||||
Year
ended
|
Year
ended
|
Year
ended
|
||||||||
December
31, 2004
|
December
31, 2003
|
December
31, 2002
|
||||||||
U.S.
GAAP:
|
||||||||||
Operating
Results Net loss
|
$
|
5,478,184
|
$
|
3,949,318
|
$
|
4,871,140
|
||||
Net
loss per share:
|
||||||||||
-
basic and diluted loss per share
|
$
|
0.26
|
$
|
0.19
|
$
|
0.24
|
As
at
|
As
at
|
As
at
|
As
at
|
As
at
|
||||||||||||
Canadian
GAAP:
|
December
31, 2004
|
December
31, 2003
|
December
31, 2002
|
December
31, 2001
|
January
31, 2001
|
|||||||||||
Financial
Position
|
||||||||||||||||
Total
assets
|
$
|
6,996,079
|
$
|
8,074,027
|
$
|
11,379,383
|
$
|
9,343,958
|
$
|
11,097,548
|
||||||
Long-term
debt
|
nil
|
nil
|
nil
|
nil
|
nil
|
|||||||||||
Shareholders’
Equity Total shareholders’ equity (net assets)
|
$
|
2,496,842
|
$
|
7,438,279
|
$
|
10,689,828
|
$
|
8,948,696
|
$
|
10,605,574
|
||||||
Capital
stock
|
$
|
24,192,321
|
$
|
24,056,853
|
$
|
23,785,884
|
$
|
18,212,490
|
$
|
16,934,162
|
||||||
Weighted
average number of common shares outstanding
|
21,276,497
|
20,967,677
|
20,406,733
|
19,097,390
|
17,376,342
|
|||||||||||
Cash
dividends declared per share
|
nil
|
nil
|
nil
|
nil
|
nil
|
As
at
|
As
at
|
As
at
|
||||||||
December
31,
|
December
31,
|
December
31,
|
||||||||
U.S.
GAAP:
|
2004
|
2003
|
2002
|
|||||||
Financial
Position
|
||||||||||
Total
assets
|
$
|
6,633,221
|
$
|
7,620,454
|
$
|
10,812,417
|
||||
Long
term debt
|
nil
|
nil
|
nil
|
|||||||
Shareholders’
Equity Total shareholders’ equity (net assets)
|
$
|
2,133,984
|
$
|
6,984,706
|
$
|
10,122,862
|
||||
Capital
stock
|
$
|
28,924,764
|
$
|
28,789,296
|
$
|
28,399,039
|
D.
|
Capitalization
and Indebtedness
|
•
|
Coronary
Artery Disease Risk Assessment
Technology
|
•
|
PREVU*
Point of Care Skin Sterol Test, which is cleared for sale in Canada,
U.S.
(CLIA-exempt) and CE-marked in Europe1
|
•
|
PREVU*
LT Skin Sterol Test (lab-processed format), currently in
clinical
trials
|
•
|
PREVU*
PT Skin Sterol Test (home, or consumer, format), currently
in
development
|
•
|
ColorectAlert™,
currently in clinical studies
|
•
|
LungAlert™,
currently in clinical studies
|
•
|
Breast
cancer test, currently in clinical
studies
|
1.
|
greater
awareness of personal wellness and the increasing role by individuals
in
health maintenance;
|
2.
|
a
health-conscious and aging population which is placing a growing
emphasis
on preventative care;
|
3.
|
technological
advances that have improved both the ease-of-use and accuracy of
diagnostic products, thereby gaining greater support from medical
practitioners; and
|
4.
|
availability
of over-the-counter (“OTC”) products and other therapies to treat serious
diseases.
|
•
|
gender
|
•
|
increasing
age
|
•
|
heredity
|
•
|
tobacco
smoking
|
•
|
high
blood pressure
|
•
|
physical
inactivity
|
•
|
diet
|
•
|
obesity
|
•
|
diabetes
mellitus
|
•
|
skin
cholesterol levels were found to be higher in individuals with abnormal
coronary angiograms than in those with normal coronary
angiograms;
|
•
|
skin
cholesterol levels were found to be elevated in individuals with
hyperlipoproteinemia compared to those with normal serum lipid levels;
and
|
•
|
skin
cholesterol levels were elevated in individuals having coronary bypass
surgery compared to age-matched healthy
controls.
|
•
|
PREVU*
LT Skin Sterol Test is a lab-processed test that is administered
painlessly and rapidly, without fasting, needles or blood sample
required.
The testing procedure samples surface skin cells from the palm of
the hand
using a specially designed adhesive, which is then sent to a laboratory
where the surface is assessed for skin cholesterol using the same
reagents
and color measurement technology. This test is currently patent pending
and in clinical trials.
|
•
|
PREVU*
PT Skin Sterol Test is a single-use, two-minute test designed primarily
for home use. It is currently in development with clinical trials
expected
to start later in 2005.
|
1.
|
determining
the relationship between skin cholesterol and serum lipid levels
in 200
patients entering the preventive cardiology program;
and
|
2.
|
determining
the relationship between skin cholesterol and functional evidence
of CAD
as demonstrated by cardiac stress testing and trans-esophageal
echocardiography (“TEE”) in the test population (100 patients
each).
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
|||||
PREVU*
Skin Sterol Test: Completed Studies
|
|
|
|
|
||||||
Skin
sterol and stress test
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Determine
relationship between skin sterol and serum lipid levels; measure
correlation of skin sterol to stress test outcome
|
Skin
sterol shown to be an independent predictor of functional CVD as
measured
by stress test outcome
|
Presented
at 31st Annual Oak Ridge Conference, 1999. Published in Journal
of Clinical Chemistry
in 2001
|
|||||
Skin
sterol and response to therapy
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Determine
ability of skin sterol to monitor patient response to lipid-lowering
medications
|
Data
suggested that skin sterol might have utility in monitoring response
to
cholesterol-lowering therapies
|
Presented
at American Association for Clinical Chemistry annual meeting in
1999
|
|||||
Measuring
skin sterol levels to assess CAD
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation; The Canadian Heart Research Centre;
The
Trillium Health Centre
|
Correlation
between skin sterol and angiography outcome
|
Demonstrated
that skin sterol was independently associated with the presence and
extent
of CAD as determined by angiography, the gold standard for diagnosis
of
CAD
|
Presented
at American Heart Association (AHA) annual meeting, 2000. Presented
at
AHA's Arteriosclerosis, Thrombosis and Vascular Biology annual meeting
in
2002; published in journal Atherosclerosis
in 2003
|
|||||
Skin
sterol and other markers of CAD risk
|
Dr.
John Mancini
|
University
of British Columbia; St. Paul's Hospital
|
Determine
correlation of skin sterol to other measures of CAD risk, including
carotid sonography, flow-mediated brachial vasoactivity and serum
markers.
|
Demonstrated
that skin sterol correlates to Framingham Global Risk Score and
inflammatory markers, notably ICAM-1
|
Published
in American
Journal of Cardiology
in 2002
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
|||||
Pediatric
skin sterol study
|
Dr.
Katherine Morrison
|
St.
Joseph's Hospital
|
Examine
skin sterol levels in children with hypercholesterolemia
|
Demonstrated
that skin sterol can be reliably measured in children
|
Presented
at the 2003 Endocrine Society Annual Meeting
|
|||||
Skin
sterol and statins
|
Dr.
Marcus Reiter
|
University
of Vienna
|
Examining
skin sterol response to certain cholesterol-lowering
medications
|
Patients
treated with statins experienced decreases in skin sterol values
as well
as in blood cholesterol; initial data shows that skin sterol may
be a
useful monitoring tool for patients taking statins
|
Data
published in Journal
of Clinical Chemistry
in January 2005
|
|||||
Skin
sterol and carotid IMT
|
Dr.
James Stein
|
University
of Wisconsin
|
Study
measuring relationship between skin sterol and CAD using carotid
IMT
|
Skin
sterol has strong correlation to carotid IMT, a well-established
risk
factor for heart disease
|
Data
presented at American College of Cardiology annual meeting, March
2005.
|
|||||
PREVU*
Skin Sterol Test: Ongoing Studies
|
||||||||||
ARISE
(Aggressive Reduction in Inflammation Stops Events)
|
Dr.
Rob Scott
|
AtheroGenics,
Inc.; study conducted at multiple sites around world
|
Study
will examine skin sterol changes in response to AtheroGenics’ AGI-1067
therapy. Trial will also provide data on relationship between skin
sterol
and primary cardiovascular events
|
|||||||
Correlation
study
|
Dr.
Jean-Claude Tardif
|
Montreal
Heart Institute
|
Data
from trial expected to demonstrate that lab-processed format of test,
PREVU*LT, correlates to PREVU* POC. Successful completion could lead
to
regulatory approval and milestone payment from McNeil
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
|||||
PREPARE
study
|
Dr.
David Waters;
Dr.
Dennis Sprecher;
Dr.
John Mancini
|
Various
|
Relationship
between skin sterol (PREVU* LT) and risk of CVD as estimated by Framingham
score
|
|||||||
Skin
sterol and new CAD risk markers (PREVU*POC* and PREVU*PT)
|
Dr.
John Mancini;
Dr.
Sammy Chan;
Dr.
Jiri Frolich
|
University
of British Columbia
|
Study
will examine relationship between skin sterol and a variety of new
and
established cardiovascular risk markers in high-risk patients. It
will
also examine how skin sterol responds to various therapies
|
|||||||
MESA
(Multi-Ethnic Study of Atherosclerosis) sub-study
|
Dr.
Pamela Ouyang
|
National
Heart, Lung and Blood Institute; Johns Hopkins Bayview Medical
Center
|
Study
examining correlation of skin sterol to early markers of CAD across
different ethnic groups
|
Interim
data demonstrated that skin sterol levels correlated with the presence
and
extent of coronary calcification
|
Interim
data presented at American Heart Association in 2003
|
|||||
All
Comers' study
|
Dr.
Dennis Sprecher
|
The
Cleveland Clinic Foundation
|
Study
examining relationship between skin sterol and Framingham Global
Risk
Score and other markers of CAD in patients suspected of having CAD.
Trial
includes PREVU* POC and lab-processed format of test
|
|||||||
PRACTICE
|
Dr.
Milan Gupta
|
William
Osler Health Centre
|
Examining
skin sterol levels in South Asians
|
Interim
data confirmed that skin sterol provides new information about a
patient’s
risk of CAD. Skin sterol may have value in stratifying patients with
established CAD who have been treated with cholesterol-lowering
medications
|
Data
presented at Canadian Cardiovascular Congress in October
2004
|
|||||
WAVE
- evaluation of skin sterol levels in patients on warfarin
therapy
|
Dr.
Sonia Anand
|
Canadian
Institute for Health Research; conducted at Hamilton General
Hospital
|
Relationship
between skin sterol and cardiac events in high-risk
patients
|
DESCRIPTION
|
INVESTIGATOR
|
PRIMARY
STUDY
SITE
|
OBJECTIVES
|
OUTCOME
|
PUBLICATIONS/
PRESENTATIONS
|
|||||
Correlation
between PREVU* POC & PREVU* LT
|
Dr.
Lawrence Leiter
|
St.
Michael’s Hospital
|
Comparing
skin sterol values generated by PREVU* POC to those obtained by PREVU*
LT
in a high-risk population
|
|||||||
Hypertension
study
|
Dr.
Pamela Ouyang
|
Johns
Hopkins
|
Examining
skin sterol changes after therapy in patients with
hypertension
|
•
|
Physician’s
office.
The non-invasive, cost effective and easy-to-use skin cholesterol
test
PREVU* POC is suitable for use in the physician’s office for risk
assessment and, perhaps, monitoring applications providing the
clinician
valuable additional data in an overall patient workup for CAD
risk.
|
•
|
Pharmacy
market.
Tests may be offered through retail pharmacies to consumers. As
well,
pharmaceutical companies might be interested in using or co-marketing
the
tests at the pharmacy level as a means of encouraging individuals
to see
their doctors for cholesterol lowering drug therapies. The Corporation
is
currently developing a consumer format of the test, called PREVU*
PT Skin
Sterol Test.
|
•
|
Screening
for insurance risk assessment.
The
market for insurance testing represents a significant opportunity
for the
lab-processed format of the Corporation’s predictive heart disease test,
PREVU* LT Skin Sterol Test, throughout North America. About 14
million new
insurance policies are granted every year, approximately 6.25 million
of
which include screening performed using oral fluid testing and/or
blood.
|
•
|
Home
testing market.
PREVU* Skin Sterol Test PT could be purchased by individuals in
a retail
pharmacy and self-administered at home to test and monitor skin
cholesterol levels. The U.S. cholesterol self-test market is projected
to
grow from about US$30 million in 2003 to just under
|
•
|
Monitoring
for drug and dietary therapy.
Given the ease of use of skin cholesterol testing, the test may
be used to
monitor the progress of therapy. Thus, pharmaceutical companies
may be
interested in using or co-marketing this test to ensure patient
compliance. The Corporation’s skin cholesterol test is not yet cleared for
this use.
|
Stage
A:
|
tumor
is limited to the wall of the colon or rectum
|
Stage
B:
|
tumor
has extended to the extracolonic or extrarectal tissue but there
is no
involvement of regional lymph nodes
|
Stage
C:
|
tumor
has spread to regional lymph nodes
|
Stage
D:
|
tumor
has spread to distant organs
|
•
|
yearly
fecal occult blood test (“FOBT”)*
|
•
|
flexible
sigmoidoscopy every five years
|
•
|
yearly
FOBT* plus flexible sigmoidoscopy every five years**
|
•
|
double
contrast barium enema (“DCBE”) every five
years
|
•
|
colonoscopy
every 10 years
|
Squamous
cell carcinoma:
|
Always
associated with smoking. Usually starts in bronchi.
|
Adenocarcinoma:
|
Begins
in mucus glands usually near the periphery of the lung.
|
Large-cell
undifferentiated
|
May
appear in any part of the lung. Tends to grow and spread
quickly.
|
T1:
|
Tumor
is smaller than 3 cm and has not spread to the main branches of
the
bronchus.
|
T2:
|
Tumor
is larger than 3 cm. Cancer has spread to the main bronchus. Cancer
partially clogs airway but does not cause pneumonia.
|
T3:
|
Tumor
has spread to the chest wall and/or the diaphragm. The cancer is
within 2
cm of the trachea. One or both lungs collapse.
|
T4:
|
Metastatic
spread. Two or more tumor modules are present in the same lobe
with
malignant pleural effusion.
|
1.
|
An
X-ray is a simple and safe procedure that is relatively ineffective.
Less
than 40% of all lung cancers can be detected by this screening
method.
|
2.
|
Conventional
Sputum Cytology has been used for over 50 years; however it is
the least
sensitive and only able to identify 20% of lung cancer cases.
|
3.
|
Spiral
CT has been hailed as the technology that holds the greatest promise
for
cost effectively screening for lung cancer. Although it holds the
ability
to detect approximately 70% of lung cancers, it has a high cost
which
translates into $300-$1,000 per test.
|
4.
|
Positron
Emission Tomography is the most accurate screening test available
at over
90% sensitivity. Since it is extremely expensive at $2,500 per
patient,
widespread use would be unfeasible.
|
5.
|
Bronchoscopy
is used as a final diagnostic option prior to surgery. It is highly
invasive and results in a 0.2% mortality rate with the majority
of
patients unable to return to daily routines for several weeks or
months.
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Method
for producing affinity-enzymatic compounds for visual indication
of
cholesterol on skin surface
|
Canada
|
1,335,968
|
June
20, 1995
|
June
20, 2012
|
|||||
Granted
|
Method
of producing affinity-enzymatic compounds for the visual detection
of
cholesterol on the surface of the skin of a patient, based on a
detecting
agent with an affinity for cholesterol and a visualization
agent
|
Europe
Austria
Great
Britain
France
Germany
Italy
Sweden
Switzerland
|
0
338 189
|
April
24, 1996
|
January
18, 2009
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Multilayer
Analytical Element
|
Australia
South
Korea
United
States
Canada
China
Europe
Belgium
Germany
Spain
France
Great
Britain
Greece
Italy
Ireland
Netherlands
Portugal
Sweden
Mexico
|
702,663
235,211
6,605,440
2,207,555
95,197,367.3
0797774
974469
|
June
3, 1999
September
21, 1999
August
12, 2003
February
24, 2004
June
23, 2004
November
10, 2004
April
15, 2005
|
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
December
14, 2015
|
|||||
Pending
|
Multilayer
Analytical Element
|
PCT
Brazil
Japan
Mexico
|
CA95/00698
PI9510038-5
HEi-8-517984
974469
|
N/A
|
N/A
|
|||||
Granted
|
Method
of Determining Skin Tissue Cholesterol
|
United
States
|
6,365,363
|
April
2, 2002
|
January
26, 2018
|
|||||
Pending
|
Method
of Determining Skin Tissue Cholesterol
|
PCT
Canada
Brazil
Europe
Japan
Hong
Kong
|
RU98/00010
2281769
PI9807594-2
98901608.4
10-5396529
00105898.2
|
Accepted
in Canada June 8, 2005
Accepted
in Japan
May
31, 2005
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Pending
|
Spectrophotometric
Measurement in Colour-Based Biochemical and Immunological
Assays
As
it pertains to Skin Cholesterol Measurement
|
PCT
Australia
Brazil
China
Europe
Russia
Hong
Kong
India
Japan
|
PCT/CA00/00918
781034
PI0013096.6
00813497.9
00954181.4
RU
2002103517
0310671.6
PCT/2002/00307
2001-51596.4
|
N/A
Accepted
in Australia March 10, 2005
|
N/A
|
|||||
Pending
|
Spectrophotometric
Measurement in Colour-Based Biochemical and Immunological
Assays
As
it Pertains to Skin Cholesterol Measurement
|
United
States
Continuation
in part
|
09/830,708
10/877,737
|
N/A
|
N/A
|
|||||
Pending
|
Direct
Assay of Cholesterol in Skin Samples
|
Canada
(PCT
filed in place of Canada)
United
States
Continuation
in part
|
2,465,427
PCT/CA2005/00642
10/835,397
Number
not yet assigned (Filed April 28,2005)
|
N/A
|
N/A
|
|||||
Pending
|
Direct
Assay of Skin Protein in Skin Samples Removed by Tape
Stripping
|
United
States
|
Number
not yet assigned (Filed May 20, 2005)
|
N/A
|
N/A
|
|||||
Pending
|
Method
and Apparatus for Non-Invasive Measurement of Skin tissue
Cholesterol
|
United
States
|
60/656,381
|
N/A
|
N/A
|
|||||
Abandoned(petition
for reinstate-ment has been filed)
|
Method
for visual indication of cholesterol on skin surface agents used
therefore
and methods for producing such agents
|
United
States
|
5,489,510
|
February
6, 1996
|
February
6, 2013
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Abandoned
(petition for reinstate-ment has been filed)
|
Method
for producing affino-enzymatic compounds and visualizing agent
and
application thereof
|
United
States
|
5,587,295
|
December
24, 1996
|
December
24, 2013
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Rectal
Mucus Test and Kit for Detecting Cancerous and Precancerous
Conditions
|
USA
|
5,162,202
|
November
10, 1992
|
December
12, 2009
|
|||||
Granted
|
Screening
Test and Kit for Cancerous and Precancerous Conditions
|
USA
|
5,348,860
|
September
20, 1994
|
October
15, 2011
|
|||||
Granted
|
Rectal
Mucus Test and Kit for Detecting Cancerous and Precancerous
Conditions
|
Japan
|
2,990,528
|
October
15, 1999
|
April
27, 2010
|
|||||
Pending
|
Spectrophotometric
Measurement in Colour-Based Biochemical and Immunological
Assays
As
it Pertains to
Cancer
Detection
|
PCT
Australia
Brazil
China
Europe
Russia
Hong
Kong
India
Japan
|
PCT/CA00/00918
781034
PI0013096.6
00813497.9
00954181.4
RU
2002103517
0310671.6
PCT/2002/00307
2001
515964
|
N/A
Accepted
in Australia March 10, 2005
|
N/A
|
|||||
Pending
|
Spectrophotometric
Measurement in Colour-Based Biochemical and Immunological
Assays
As
it Pertains to
Cancer
Detection
|
USA
Continuation
in part
|
09/830,708
10/877,757
|
N/A
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Cancer
|
USA
|
6,187,591
|
February
13,2001
|
March
16, 2019
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Australia
|
766,057
|
January
29, 2004
|
November
3, 2019
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Canada
|
2,352,184
|
N/A
|
N/A
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Brazil
|
PI19915005
|
N/A
|
N/A
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Israel
|
139545
|
N/A
|
N/A
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Mexico
|
012243
|
N/A
|
N/A
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
Korea
|
2001-7005707
|
N/A
|
N/A
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Cancer
|
India
|
INPCT/2001/00591
|
N/A
|
N/A
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
USA
|
5,416,025
|
May
16, 1995
|
November
29, 2013
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Europe
|
0731914
|
November
23, 1994
|
November
23, 2014
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
France
|
0731914
|
April
18, 2001
|
November
23, 2014
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Spain
|
ES
2155513
|
April
18, 2001
|
November
23, 2014
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Germany
|
69427131.4
|
April
18, 2001
|
November
23, 2014
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Great
Britain
|
0731914
|
April
18, 2001
|
November
23, 2014
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Italy
|
0731914
|
April
18, 2001
|
November
23, 2014
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Australia
|
687,939
|
March
5, 1998
|
November
23, 2014
|
|||||
Granted
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
South
Africa
|
94/9290
|
October
25, 1995
|
November
23, 2014
|
|||||
Pending
|
Screening
Test for the Early Detection of Colorectal Neoplasia
|
Canada
|
2,176,508
|
N/A
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Screening
Test and Kit for Cancerous and Precancerous Conditions
|
USA
|
5,348,860
|
September
20,1994
|
October
15, 2011
|
|||||
Pending
|
Spectrophotometric
Measurement in Colour-Based Biochemical and Immunological
Assays
As
it Pertains to Cancer
Detection
|
PCT
Australia
Brazil
China
Europe
Russia
Hong
Kong
India
Japan
|
PCT/CA00/00918
781034
PI0013096.6
00813497.9
00954181.4
RU
2002103517
0310671.6
PCT/2002/00307
2001
515964
|
N/A
Accepted
in Australia March 10, 2005
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Pending
|
Spectrophotometric
Measurement in Colour-Based Biochemical and Immunological
Assays
As
it Pertains to Cancer
Detection
|
USA
Continuation
in part
|
09/830,708
10/877,737
|
N/A
|
N/A
|
Patent
Status
|
Title
|
Jurisdiction
|
Patent
Number
|
Grant
Date
|
Expiry
Date
|
|||||
Granted
|
Method
for Detecting Prostate Cancer
|
USA
|
5,801,004
|
September
1, 1998
|
September
1, 2015
|
Accumulated
|
Net
Book
|
|||||||||
Cost
($)
|
Depreciation
($)
|
Value
($)
|
||||||||
Manufacturing
equipment
|
18,150
|
6,600
|
11,550
|
|||||||
Computer
equipment
|
270,704
|
143,925
|
126,779
|
|||||||
Furniture
and equipment
|
60,172
|
39,357
|
20,815
|
|||||||
Research
instrumentation
|
606,104
|
373,439
|
232,665
|
|||||||
Laboratory
equipment
|
25,501
|
7,735
|
17,766
|
|||||||
Leasehold
improvements
|
21,479
|
10,099
|
11,380
|
|||||||
TOTAL
|
1,002,110
|
581,155
|
420,955
|
•
|
a
$253,000 increase in spending on clinical trials for skin cholesterol
and
cancer to $488,000 from $235,000 in 2003. This increase is related
to a
lung cancer trial (the “I-ELCAP” study) and the large skin cholesterol
study being conducted with AtheroGenics, Inc. that commenced in
the latter
part of 2003. The Corporation conducted at least 19 clinical trials
during
the year;
|
•
|
increased
filing fees on intellectual property, which amounted to $196,000
compared
with $92,000 in fiscal 2003. During the year, the Corporation filed
new
patents on skin cholesterol in numerous European countries. In
addition,
the Corporation incurred costs of $96,000 related to filing a petition
for
reinstatement of two U.S. patents for skin cholesterol that had
been
deemed abandoned. The Corporation is continuing to seek reinstatement;
|
•
|
increases
in total compensation and benefits for research personnel of $221,000,
reflecting annual increases plus accruals for incentive compensation
based
on performance;
|
•
|
increases
in subcontract research expenditures of $114,000, as the Corporation
continued further development of new prototypes of laboratory and
consumer
(over-the-counter) formats of the skin cholesterol technology;
and
|
•
|
a
reduction in stock-based compensation, which was prospectively
adopted in
2003, resulted in non-cash expenses for research personnel of $124,000
in
2004 compared with $189,000 for 2003, reflecting fewer options
being
granted in 2004.
|
•
|
a
one-time cost of $478,000 in 2004 related to the Corporation’s unsolicited
offer to acquire the shares of IBEX Technologies Inc. (“IBEX”). The
Corporation allowed the offer to expire in December 2004 and did
not
complete the purchase;
|
•
|
a
$221,000 increase in stock-based compensation for options for
administrative personnel that resulted in a non-cash expense of
$476,000
for the year compared with $255,000 for 2003. This increase was
primarily
for options granted in 2004 pursuant to a U.S. consulting contract
that
vested over nine months and for the cashless exercise of options
by an
officer of the Corporation;
|
•
|
an
$80,000 increase in professional fees, primarily due to legal fees
related
to finalizing the global licensing agreement with
McNeil;
|
•
|
a
$64,000 increase in insurance premiums over 2003 as a result of
listing on
the American Stock Exchange
(“Amex”);
|
•
|
a
reduction to nil in 2004 ($179,000 in 2003) for costs related to
the
Corporation’s U.S. listing on Amex, which was completed in September
2003;
|
•
|
a
reduction in travel expenses by $76,000 following completion of
the McNeil
agreement as a result of less foreign travel;
and
|
•
|
an
increase of $160,000 in total compensation and benefits for administration
personnel reflecting annual increases plus accrued incentive compensation
based on performance.
|
Total
|
Less
than
1
Year
|
1
- 2 Years
|
2−5
Years
|
||||||||||
Clinical
Trials
|
$
|
908,000
|
$
|
618,000
|
$
|
290,000
|
−
|
||||||
Research
Agreements
|
$
|
90,000
|
$
|
90,000
|
nil
|
−
|
|||||||
Other
|
$
|
115,000
|
$
|
115,000
|
nil
|
−
|
|||||||
Total
|
$
|
1,113,000
|
$
|
823,000
|
$
|
290,000
|
−
|
Approx.
|
Estimate
of
|
|||||||||
Description
/
|
Phase
of
|
%
|
Completion
|
|||||||
Product
|
Indication
|
Development
|
Completed
|
Collaborator
|
of
Phase
|
|||||
Coronary
Artery Disease (CAD) Risk Assessment Technology:
|
||||||||||
PREVU*
POC Skin
|
Point
of care skin
|
Regulatory
|
100%
|
McNeil
|
2005
|
|||||
Sterol
Test
|
cholesterol
test that
|
clearance
in
|
||||||||
(previously
Cholesterol
|
provides
information about
|
Canada,
U.S. and
|
||||||||
1,2,3™)
|
an
individual’s risk of
|
Europe;
start of
|
||||||||
coronary
artery disease;
|
sales
by McNeil
|
|||||||||
clinical
studies to expand
|
5%
|
Various
|
2006
|
|||||||
indication
for use
|
Expand
regulatory
|
clinical
trial
|
||||||||
claims
|
sites
|
|||||||||
PREVU*
LT Skin Sterol Test
|
Lab-processed
skin
|
Clinical
trials in
|
10%
|
McNeil
|
2005/06
|
|||||
cholesterol
test
|
progress
|
|||||||||
Commercial
|
0
|
McNeil
|
2005/06
|
|||||||
launch
in select
|
||||||||||
markets
|
||||||||||
PREVU*
PT Skin Sterol Test
|
Consumer
version of the
|
Product
|
50%
|
McNeil
|
2005
|
|||||
skin
cholesterol test
|
development
|
|||||||||
Cancer
Technologies:
|
||||||||||
ColorectAlert™&
Colopath™
|
Mucus
tests for early
|
2,000
patients
|
100%
|
St.
Michael’s
|
2004
|
|||||
detection
of colorectal
|
tested
in clinical
|
Hospital
|
||||||||
cancer
|
trials
|
|||||||||
Clinical
studies to
|
||||||||||
support
|
||||||||||
commercialization
|
10%
|
N/A
|
2006
|
|||||||
LungAlert™
|
Sputum
test for early
|
1,000
patients
|
60%
|
St.
Joseph’s
|
2005/06
|
|||||
detection
of lung cancer
|
tested
in clinical
|
Hospital;
|
||||||||
trials
|
I-ELCAP
|
|||||||||
Expand
clinical
|
0
|
2006
|
||||||||
trials;
publish
|
||||||||||
scientific
papers
|
||||||||||
Breast
Cancer Test
|
Aspirate
test for early
|
Pivotal
study
|
10%
|
University
of
|
2005/06
|
|||||
detection
of breast cancer
|
underway
|
Louisville
|
||||||||
All
Cancer Tests
|
Improvement
of assay
|
Alternative
format
|
||||||||
method
|
development
|
50%
|
N/A
|
2005
|
Historical
|
||||||||||||||||
Fiscal
Year
|
Fiscal
Year
|
11-Month
|
Fiscal
Year
|
Cumulative
|
||||||||||||
Ended
|
Ended
|
Period
Ended
|
Ended
|
total
since
|
||||||||||||
Product
|
Dec.
31, 2004
|
Dec.
31, 2003
|
Dec.
31, 2002
|
Dec
31, 2001
|
Feb.
1, 1997
|
|||||||||||
CAD
Risk Assessment Technologies
|
$
|
1,476,000
|
$
|
860,000
|
$
|
1,188,000
|
$
|
1,297,000
|
$
|
6,542,000
|
||||||
ColorectAlert™
and ColoPath™
|
$
|
304,000
|
$
|
327,000
|
$
|
495,000
|
$
|
488,000
|
$
|
2,681,000
|
||||||
LungAlert™
|
$
|
255,000
|
$
|
228,000
|
$
|
178,000
|
$
|
118,000
|
$
|
829,000
|
||||||
Breast
Cancer
|
$
|
42,000
|
$
|
45,000
|
─
|
─
|
$
|
87,000
|
F.
|
Off-Balance Sheet
Arrangements
|
Long-term
|
||||||
Annual
Compensation
|
Compensation
|
|||||
Other
|
||||||
Annual
|
||||||
Compen-
|
Securities
Under
|
All
other
|
||||
Financial
Year
|
Salary
|
Bonus
|
sation(1)
|
Option
Granted
|
Compensation
|
|
Name
and Position
|
Ended
|
($)
|
($)
|
($)
|
(#)
|
($)
|
Dr.
Brent Norton
President
and Chief Executive Officer
|
Dec.
31, 2004
Dec.
31, 2003
Dec.
31, 2002
|
$285,000
$285,000
$222,500
|
$142,500
-
$45,000
|
-
-
-
|
-
70,000
360,000
|
-
-
$6,750(2)
|
Ronald
Hosking
Vice
President, Finance and Chief Financial Officer
|
Dec.
31, 2004
Dec.
31, 2003
Dec.
31, 2002
|
$167,500
$150,000
$126,000
|
$30,000
$24,000
-
|
-
-
-
|
-
85,000
36,000
|
-
-
$6,750(2)
|
Michael
Evelegh
Ph.D.,
Executive Vice President, Clinical and Regulatory Affairs
|
Dec.
31, 2004
Dec.
31, 2003
Dec.
31, 2002
|
$225,000
$225,000
$215,000
|
$56,250
-
$105,000
|
-
-
-
|
-
50,000
110,000
|
-
-
-
|
Tim
Currie
Vice
President, Corporate Development
|
Dec.
31, 2004
|
$150,000
|
$45,000
|
-
|
35,000
|
-
|
(1)
|
Unless
otherwise disclosed, the aggregate amount of perquisites and
other
personal benefits do not exceed the lesser of $50,000 and 10%
of the
salary and the bonus of each Named Executive Officer for the
years ended
December 31, 2004, 2003 and 2002.
|
(2)
|
This
compensation reflects the value of the Common Shares issued by
the
Corporation to such Named Executive Officers pursuant to the Corporation’s
employee share purchase plan. The value is based upon the closing
price of
the Common Shares on the Toronto Stock Exchange on the respective
dates of
the issuance of such shares. See “Executive Compensation - Employee Share
Purchase Plan”.
|
2.
|
Long-term
Incentive Plan Awards during the Year Ended December 31,
2004
|
Name
and Position
|
Securities
Under Options
Granted
(#) (1)
|
%
of Total Options Granted to Employees in Financial
Year
|
Exercise
or Base Price
($/Security)
|
Market
Value of Securities Underlying Options on the Date of Grant
($/Security)
|
Expiration
Date
|
|||||
Tim
Currie
Vice
President, Corporate Development
|
35,000
|
13.5%
|
$4.00
|
$4.00
|
Feb.
23, 2009
|
(1)
|
These
options will vest annually over a period of five years.
|
4.
|
Aggregated
Option Exercises during the Year Ended December 31, 2004 and Financial
Year-end Option Values
|
Name
and Position
|
Securities
Acquired
on
Exercise
(#)
|
Aggregate
Value
Realized
($)
|
Unexercised
Options
at
FY-End (#)
Exercisable/
Unexercisable
|
Value
of Unexercised
in-the-money
Options
at
FY-End
($)
Exercisable/
Unexercisable
(4)
|
||||
Dr.
Brent Norton, President and
Chief
Executive Officer
|
27,713(1)
|
$94,500(1)
|
550,000(2)
/
447,500(3)/102,500
|
$33,600
/
$28,350/$5,250
|
||||
Ronald
Hosking,
Vice
President, Finance and Chief Financial Officer
|
-
|
-
|
121,000(2)
/
42,200(3)/78,800
|
$7,500
/
$1,500/$6,000
|
||||
Michael
Evelegh, Ph.D., Executive Vice President, Clinical and Regulatory
Affairs
|
-
|
-
|
220,000(2)
/
167,500(3)/52,500
|
$7,000
/
$5,250/$1,750
|
||||
Tim
Currie
Vice
President, Corporate Development
|
-
|
-
|
221,000(2)
/
95,400(3)/125,600
|
$42,500
/
$26,000/$16,500
|
(1)
|
On
September 13, 2004, Dr. Norton exercised, on a cashless basis,
options to
acquire 75,000 Common Shares at an exercise price of $2.15 per
share. Upon
such exercise, the Corporation issued 27,713 Common Shares to Dr.
Norton
with an aggregate value equal to the difference between the exercise
price
of the options and the fair market value of the Common Shares as
at such
date. The Toronto Stock Exchange and the Board of Directors of
the
Corporation approved this cashless
exercise.
|
(2)
|
These
options will vest (i) upon the occurrence of certain performance-related
milestones of the Corporation relating to the Corporation’s core
technologies (e.g. launch of clinical trials, FDA clearance of
initial
claims); (ii) based upon the Corporation’s financial performance (e.g.
earnings per share targets); and/or (iii) annually over a pre-determined
number of years.
|
(3)
|
These
options were not yet exercisable as the milestones or time periods
referred to in note (1) above had not yet been
attained.
|
(4)
|
Based
upon a closing price of $3.00 for the Common Shares on the Toronto
Stock
Exchange on December 31, 2004.
|
Name
|
|
Position
|
|
Term
|
Dr.
H.B. Brent Norton
|
|
President,
Chief Executive Officer
and
Director
|
|
President,
CEO: 1992-present
Director:
March 17, 1993-present
|
Stephen
A. Wilgar
|
|
Director
and Chairman
|
|
March
17, 1993-present
|
John
C. Carroll
|
|
Director
|
|
June
6, 1994-May 25, 2005
|
Anthony
F. Griffiths
Ronald
D. Henriksen
|
|
Director
Director
|
|
July
13, 1995-present
June
16, 2004-present
|
David
A. Rosenkrantz
|
|
Director
|
|
June
11, 1998-present
|
Name
|
|
Common
Shares
held
directly and beneficially
|
%
of
Outstanding
Common
Shares
as of April 30, 2003
|
Options
outstanding
|
Exercise price |
Expiration
date
|
||||||
Dr.
H.B. Brent Norton
|
|
2,421,748
|
|
11.2
|
%
|
|
120,000
|
|
$
|
3.45
|
|
Feb.
1, 2006
|
|
|
|
|
|
|
120,000
|
|
$
|
4.00
|
|
Feb.
16, 2007
|
|
|
|
|
|
|
|
240,000
|
|
$
|
2.86
|
|
Nov.
16, 2007
|
|
|
|
70,000
|
$
|
4.00
|
Dec.
5, 2008
|
|||||||
100,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||
Michael
Evelegh, Ph.D
|
|
379,261
|
|
1.8
|
%
|
|
60,000
|
|
$
|
3.50
|
|
Feb.
1, 2006
|
|
|
|
|
|
|
60,000
|
|
$
|
4.00
|
|
Feb.
16, 2007
|
|
|
|
|
|
|
|
50,000
|
|
$
|
2.86
|
|
Nov.
16, 2007
|
|
|
|
|
50,000
|
|
$
|
4.00
|
|
Dec.
5, 2008
|
||||
Ronald
G. Hosking
|
|
283,778
|
|
1.3
|
%
|
|
36,000
|
|
$
|
4.00
|
|
Feb.
16, 2007
|
50,000
|
$
|
2.85
|
Jun
27, 2008
|
|||||||||
35,000
|
$
|
4.00
|
Dec.
5, 2008
|
|||||||||
65,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||
52,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||
Tim
Currie
|
4,000
|
0.0
|
%
|
|
70,000
|
$
|
2.50
|
Feb.
1, 2006
|
||||
20,000
|
$
|
3.45
|
Mar.
1, 2006
|
|||||||||
10,000
|
$
|
3.60
|
Mar.
20, 2006
|
|||||||||
36,000
|
$
|
4.00
|
Feb.
16, 2007
|
|||||||||
50,000
|
$
|
2.85
|
Mar.
3, 2008
|
|||||||||
35,000
|
$
|
4.00
|
Feb.
23, 2009
|
|||||||||
52,000
|
$
|
2.95
|
Feb.
6, 2010
|
|||||||||
Stephen
A. Wilgar
|
|
275,038
|
|
1.3
|
%
|
|
20,000
|
|
$
|
4.61
|
|
July
17, 2005
|
|
|
|
|
|
|
10,000
|
|
$
|
2.86
|
|
Nov.
16, 2007
|
|
|
|
|
|
|
|
30,000
|
|
$
|
4.00
|
|
Dec.
5, 2008
|
|
30,000
|
$
|
4.09
|
Aug.
7, 2009
|
|||||||||
John
C. Carroll
|
|
263,442
|
|
1.2
|
%
|
|
10,000
|
|
$
|
4.61
|
|
July
17, 2005
|
|
|
|
|
|
|
5,000
|
|
$
|
2.86
|
|
Nov.
16, 2007
|
|
|
|
|
15,000
|
|
$
|
4.00
|
|
Dec.
5, 2008
|
||||
|
|
15,000
|
$
|
4.09
|
Aug.
7, 2009
|
Name
|
|
Common
Shares held directly and beneficially
|
|
%
of Outstanding Common Shares as of
April 30, 2003
|
|
|
Options
outstanding
|
Exercise
price
|
|
Expiration
date
|
||
Anthony
F. Griffiths
|
|
510,500
|
|
2.4
|
%
|
|
10,000
|
|
$
|
4.61
|
|
July
17, 2005
|
|
|
|
|
|
|
5,000
|
|
$
|
2.86
|
|
Nov.
16, 2007
|
|
|
|
|
|
|
|
15,000
|
|
$
|
4.00
|
|
Dec.
5, 2008
|
|
|
|
|
|
|
|
15,000
|
$
|
4.09
|
Aug.
7, 2009
|
|||
David
A. Rosenkrantz
|
|
346,133
|
|
1.6
|
%
|
|
10,000
|
|
$
|
4.61
|
|
July
17, 2005
|
|
|
|
|
|
|
5,000
|
|
$
|
2.86
|
|
Nov.
16, 2007
|
|
|
|
|
|
|
|
15,000
|
|
$
|
4.00
|
|
Dec.
5, 2008
|
|
|
|
|
|
|
|
|
15,000
|
$
|
4.09
|
Aug.
7, 2009
|
||
Ronald
Henriksen
|
0
|
0.0
|
%
|
15,000
|
$
|
3.50
|
Apr.
12, 2009
|
|
Number
of Voting
Securities
Owned
|
||||||
Name
|
Common
Shares
|
Percentage
of Class
|
|||||
Dr.
H.B. Brent Norton
|
2,421,748
|
11.2
|
%
|
Name
|
Date
|
Total
Outstanding as of Dec. 31, 2004($)
|
Total
Outstanding as of April 30,
2005($)
|
|||||||
Michael
Evelegh, Ph.D.
|
Mar-2002
|
120,000
|
nil
|
|||||||
Total
|
|
120,000
|
nil
|
|
•
|
|
Consolidated
Balance Sheets
|
|
•
|
|
Consolidated
Statements of Loss and Deficit
|
|
•
|
|
Consolidated
Statements of Cash Flows
|
|
•
|
|
Notes
to Consolidated Financial Statements
|
B. | Significant Changes | ||
None. | |||
ITEM 9. The Offer And Listing. | |||
A. | Offer and Listing Details | ||
|
1.
|
|
Indicate
the expected price at which the securities will be offered or the
method
of determining the price, and the amount of any expenses specifically
charged to the subscriber or purchaser.
|
Not Applicable. |
|
2.
|
|
If
there is not an established market for the securities, the document
shall
contain information regarding the manner of determination of the
offering
price as well as of the exercise price of warrants and the conversion
price of convertible securities, including who established the
price or
who is formally responsible for the determination of the price,
the
various factors considered in such determination and the parameters
or
elements used as a basis for establishing the price.
|
Not Applicable. |
|
3.
|
|
If
the corporation’s shareholders have pre-emptive purchase rights and where
the exercise of the right of pre-emption of shareholders is restricted
or
withdrawn, the corporation shall indicate the basis for the issue
price if
the issue is for cash, together with the reasons for such restriction
or
withdrawal and the beneficiaries of such restriction or withdrawal
if
intended to benefit specific persons.
|
Not Applicable. |
|
4.
|
|
The
following table sets forth information regarding the price history
of the
Common Shares on the Toronto Stock Exchange and the American Stock
Exchange for the periods indicated.
|
|
(a)
|
|
for
the five most recent full financial years: the annual high and
low market
prices:
|
TSX
|
Amex
|
||||||||||||
|
High
($)
|
Low
($)
|
High
($)
|
Low
($)
|
|||||||||
Dec-04
|
|
|
4.70
|
|
|
2.60
|
|
|
3.40
|
|
|
1.88
|
|
Dec-03
|
|
|
4.89
|
|
|
2.41
|
|
|
3.65
|
|
|
2.84
|
|
Dec-02
|
|
|
7.15
|
|
|
2.20
|
|
|
-
|
|
|
-
|
|
Dec-01
|
|
|
6.00
|
|
|
3.09
|
|
|
-
|
|
|
-
|
|
Jan-01
|
|
|
7.00
|
|
|
2.55
|
|
|
-
|
|
|
-
|
|
(b)
|
|
for
the most recent full financial years and any subsequent period:
the high
and low market prices for each full financial quarter:
|
TSX
|
Amex
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
($)
|
($)
|
($)
|
($)
|
||||||||||
Q1/05
|
4.14
|
|
|
2.91
|
|
|
3.50
|
|
|
2.35
|
|
||
Jan-Mar
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q4/04
|
|
|
3.50
|
|
|
2.77
|
|
|
2.83
|
|
|
2.33
|
|
Oct-Dec
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q3/04
|
|
|
4.17
|
|
|
3.00
|
|
|
3.20
|
|
|
2.31
|
|
July-Sept
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2/04
|
|
|
4.70
|
|
|
2.60
|
|
|
3.40
|
|
|
1.88
|
|
Apr-Jun
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1/04
|
|
|
4.25
|
|
|
3.60
|
|
|
3.30
|
|
|
2.70
|
|
Jan-Mar
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q4/03
|
|
|
4.70
|
|
|
3.60
|
|
|
3.60
|
|
|
2.84
|
|
Oct-Dec
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q3/03
|
|
|
4.89
|
|
|
2.67
|
|
|
3.65
|
|
|
2.88
|
|
July-Sept
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q2/03
|
|
|
3.00
|
|
|
2.41
|
|
|
-
|
|
|
-
|
|
Apr-Jun
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Q1/03
|
|
|
3.25
|
|
|
2.50
|
|
|
-
|
|
|
-
|
|
Jan-Mar
|
|
|
|
|
|
|
|
|
|
|
|
|
(c)
|
|
for
the most recent six months: the high and low market prices for
each month:
|
TSX
|
AMEX
|
||||||||||||
|
High
($)
|
Low
($)
|
High
($)
|
Low
($)
|
|||||||||
May-05
|
|
|
3.75
|
|
|
2.92
|
|
|
2.85
|
|
|
2.27
|
|
Apr-05
|
3.94
|
|
|
2.95
|
|
|
3.27
|
|
|
2.40
|
|||
Mar-05
|
4.14
|
|
|
3.50
|
|
|
3.50
|
|
|
2.91
|
|||
Feb-05
|
3.90
|
|
|
3.01
|
|
|
3.10
|
|
|
2.48
|
|||
Jan-05
|
3.15
|
|
|
2.91
|
|
|
2.59
|
|
|
2.35
|
|||
Dec-04
|
3.19
|
|
|
2.77
|
|
|
2.58
|
|
|
2.33
|
|||
Nov-04
|
3.50
|
|
|
2.96
|
|
|
2.83
|
|
|
2.51
|
|
(d)
|
|
for
pre-emptive issues, the market prices for the first trading day
in the
most recent six months, for the last trading day before the announcement
of the offering and (if different) for the latest practicable date
prior
to publication of the document.
|
Not Applicable. |
|
5.
|
|
State
the type and class of securities being offered or listed and furnish
the
following information:
|
|
(a)
|
|
Indicate
whether the shares are registered shares or bearer shares and provide
the
number of shares to be issued and to be made available to the market
for
each kind of share. The nominal par or equivalent value should
be given on
a per share basis and, where applicable, a statement of the minimum
offer
price. Describe the coupons attached, if applicable.
|
Not Applicable. |
|
(b)
|
|
Describe
arrangements for transfer and any restrictions on the free transferability
of the shares.
|
Not Applicable. |
|
6.
|
|
If
the rights evidenced by the securities being offered or listed
are or may
be materially limited or qualified by the rights evidenced by any
other
class of securities or by the provisions of any contract or other
documents, include information regarding such limitation or qualification
and its effect on the rights evidenced by the securities to be
listed or
offered.
|
Not Applicable. |
|
7.
|
|
With
respect to securities other than common or ordinary shares to be
listed or
offered, outline briefly the rights evidenced thereby.
|
Not Applicable. |
A.
|
Share
Capital
|
|
•
|
|
for
purposes of the U.S. Internal Revenue Code of 1986, as amended,
through
the date hereof (the “Code”), are U.S. persons and, for purposes of the
Income Tax Act (Canada)(the “Income Tax Act”) and the Canada-United States
Income Tax Convention (1980), are non-residents of Canada and residents
of
the U.S. respectively, at all relevant times;
|
|
•
|
|
hold
Common Shares as capital assets for purposes of the Code and capital
property for the purposes of the Income Tax Act;
|
|
•
|
|
deal
at arm’s length with, and are not affiliated with, the Corporation for
purposes of the Income Tax Act; and
|
|
•
|
|
do
not and will not use or hold the Common Shares in carrying on a
business
in Canada.
|
|
•
|
|
the
Income Tax Act and regulations under the Income Tax Act;
|
|
•
|
|
the
Code and Treasury regulations under the Code;
|
|
•
|
|
the
Canada-United States Income Tax Convention (1980);
|
|
•
|
|
the
administrative policies and practices published by the Canada Customs
and
Revenue Agency, formerly Revenue Canada;
|
|
•
|
|
all
specific proposals to amend the Income Tax Act and the regulations
under
the Income Tax Act that have been publicly announced by or on behalf
of
the Minister of Finance (Canada) prior to the date of this report;
|
|
•
|
|
the
administrative policies published by the U.S. Internal Revenue
Service;
and
|
|
•
|
|
judicial
decisions.
|
|
•
|
|
75%
or more of the Corporation’s gross income is “passive income,” which
includes interest, dividends and certain rents and royalties; or
|
|
•
|
|
the
average quarterly percentage, by fair market value of the Corporation’s
assets that produce or are held for the production of “passive income,” is
50% or more of the fair market value of all the Corporation’s assets.
|
A.
|
Disclosure
Controls and
Procedures
|
B.
|
Changes
in Internal Controls
|
1.
|
Over
10 years experience in investing as a principal in private companies
as
Chairman of Patica Corporation, a merchant banking
company
|
2.
|
Over
7 years experience in investing in and bringing to the public markets
junior, high-growth companies
|
3.
|
Controlling
shareholder of several private
corporations
|
4.
|
Chief
Compliance Officer of Patica Securities Limited, a Limited Market
Dealer
in Ontario, as defined and regulated by the Ontario Securities
Commission
|
5.
|
Former
Chief Compliance Officer for Patica Securities Inc. (now, Kingsdale
Capital Markets Inc.), regulated by the Investment Dealers Association
and
the Ontario Securities Commission,
and
|
6.
|
Over
10 years serving as a director on various public company boards,
including
work chairing and participating on several audit committees
|
2003
|
2004
|
||||||||||||
Amount
|
%
|
Amount
|
%
|
||||||||||
Audit
Fees
|
$
|
112,433
|
91.6
|
115,505
|
44.5
|
||||||||
Audit-Related
Fees
|
-
|
-
|
127,110
|
48.9
|
|||||||||
Tax
Fees(1)
|
10,280
|
8.4
|
17,205
|
6.6
|
|||||||||
All
Other Fees
|
-
|
-
|
-
|
-
|
|||||||||
Total
|
122,713
|
100.0
|
259,820
|
100.0
|
(1)
|
"Tax
fees" are for professional services rendered by our auditors for
tax
compliance, tax advice on actual or contemplated transactions and
tax
consulting associated with international transfer
prices.
|
1.1
|
|
Articles
of Amalgamation of the Corporation. Previously filed as an exhibit
to the
Corporation’s Registration
Statement on Form 20-F filed on June 18, 2002 (File No.
001-31360).
|
|
1.2
|
|
By-laws
of the Corporation. Previously filed as an exhibit to the Corporation’s
Registration Statement
on Form 20-F filed on June 18, 2002 (File No.
001-31360).
|
|
4.1*
|
|
Supply
Agreement by and between the Registrant and Diagnostic Chemicals
Limited
dated June 19, 2001. Previously filed as an exhibit to the Corporation’s
Registration Statement on Form 20-F filed on June 18, 2002 (File
No.
001-31360).
|
|
4.2*
|
|
Cholesterol
1,2,3 - Skin Cholesterol Measurement System - Product Development,
Manufacturing and Marketing and Sales Agreement by and between
the
Registrant and X-Rite, Inc. dated May 14, 1999. Previously filed
as an
exhibit to the Corporation’s Registration Statement on Amendment No. 1 to
the Form 20-F filed on October 28, 2002 (File No.
001-31360).
|
|
4.3
|
|
Employment
Agreement by and between the Registrant and Ronald Hosking dated
Feb. 4,
1998. Previously filed as an exhibit to the Corporation’s Registration
Statement on Form 20-F filed on June 18, 2002 (File No. 001-31360).
|
|
4.4
|
|
Employment
Agreement by and between the Registrant and Dr. H.B. Brent Norton
dated
Jan. 1, 2001. Previously filed as an exhibit to the Corporation’s
Registration Statement on Form 20-F filed on June 18, 2002 (File
No.
001-31360).
|
|
4.5
|
|
Employment
Agreement by and between the Registrant and Michael Evelegh dated
Jan 1,
2001. Previously filed as an exhibit to the Corporation’s Registration
Statement on Amendment No.1 to the Form 20-F filed on October 28,
2002
(File No. 001-31360).
|
|
4.6
|
|
Lease
Agreement by and among the Registrant, and 448048 Ontario Inc.
dated
November 19, 2004.
|
|
4.7*
|
|
Research
and Development and Use of Space Agreement by and between McMaster
University and the Registrant dated October 31, 2000. Previously
filed as
an exhibit to the Corporation’s Registration Statement on Amendment No.2
to the Form 20-F filed on December 30, 2002 (File No.
001-31360).
|
|
4.8*
|
|
License,
Development and Supply Agreement between McNeil PDI Inc. and the
Registrant dated May 9, 2002. Previously filed as an exhibit to
the
Corporation’s Registration Statement on Amendment No. 4 to the Form 20-F
filed on March 7, 2003 (File No. 001-31360).
|
|
4.9*
|
|
Amendment
to License, Development and Supply Agreement by and between McNeil
PDI
Inc. and the Registrant dated December 20, 2002. Previously filed
as an
exhibit to the Corporation’s Registration Statement on Amendment No. 4 to
the Form 20-F filed on March 7, 2003 (File No.
001-31360).
|
|
4.10*
|
License,
Development and Supply Agreement by and between McNeil PDI Inc.,
McNeil
Consumer & Specialty Pharmaceuticals Division of McNeil-PPC, Inc., IMI
International Medical Innovations Inc. (Switzerland) and the Registrant,
dated May 28, 2004. Previously filed as an exhibit to a 6K filed
on June
9, 2004 (File No. 001-31360)
|
||
4.11
|
|
|
Code
of Ethics/Code of Business Conduct previously filed as an Exhibit
to the
Corporation’s Registration Statement on Form 20-F filed on June 4, 2003
(File No. 001-31360)
|
4.12
|
Fiscal
2004 consolidated financial statements and notes to the consolidated
financial statements previously filed under Form 6-K on April 4,
2005
(File No. 001-31360)
|
12.1
|
|
|
Certification
of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act.
|
12.2
|
|
|
Certification
of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley
Act.
|
13.1
|
|
|
Certification
of Chief Executive Officer and Chief Financial Officer Pursuant
to Section
906 of the Sarbanes-Oxley Act.
|
*
|
|
|
Certain
confidential information contained in this exhibit, marked by brackets
with asterisks, has been omitted and filed separately with the
Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities
Exchange
Act of 1934, as amended.
|
IMI INTERNATIONAL MEDICAL INNOVATIONS INC. | |||
|
|
/s/ RONALD
HOSKING
|
|
By:
|
|
Ronald
Hosking
|
|
Its:
|
|
Vice
President, Finance and Chief Financial
Officer
|