The worldwide market for rapid quantitative immunoassay Point-of-Care (POC)
testing is estimated at US$5 billion with significant annual growth expected.
Hundreds of distinct immunoassay-based tests are currently performed on extremely
accurate centralized lab analyzers. Test results from these lab systems however
take precious time and the associated costs are considerable. Historically,
there has been no POC alternative capable of producing similar high quality
quantitative information.
The Company’s RAMP System has achieved sufficient performance to enable
the transition of these tests from the lab to the POC. The benefits include
both tremendous cost advantages and improved patient outcomes by accelerating
the turnaround time of critical diagnostic information. Further, entirely new
POC applications are emerging in other large potential market opportunities
by virtue of superior performance.
INVESTMENT HIGHLIGHTS
Proprietary and Proven Immunoassay Platform
Core Competency in Rapid Product Development
Increasing Revenue from Product Sales
2004 revenue growth of 157%
Eight Commercially Available Tests in Three Markets
Cardiac Marker Tests for diagnosing heart attack
(troponin I, myoglobin and CK-MB)
Biodefense Tests for the on-site detection of anthrax, ricin, smallpox and
botulinum toxin
RAMP West Nile Virus Test for environmental monitoring
Independently Validated Performance Leader Across Product Lines
Cardiovascular: Regulatory Clearance in US, Canada, China and Europe Biodefense:
US Department of Homeland Security/AOAC International West Nile Virus: US CDC
& Health Canada’s National Microbiology Lab
Partnerships
3M Health Care: Clinical Infectious Disease Test
Shionogi & Co: BNP Test for Congestive Heart Failure in Japan
General Dynamics Canada: Biodefense Technology Integration
Multiple Large Market Opportunities
Cardiovascular Testing for AMI and CHF:
$1 Billion
Clinical Infectious Disease Testing:
$1 Billion
Biodefense Market:
$200 Million
Environmental Infectious Diseases:
$25 Million
2005 MILESTONES
Increase revenue from product sales
Ratify additional new product development collaborations and commercialization
agreements
Advance infectious disease test into clinical trials
Expand US sales group and international distribution network
Expand product portfolio
Secure a listing on a US stock exchange
-1-
Response Biomedical
Corp
LETTER
TO SHAREHOLDERS
Dear Shareholder
For Response Biomedical, 2004
produced widespread industry and stakeholder recognition that we have raised
the performance of lateral flow immunoassays to a new level of excellence with
our RAMP Platform. Definitive independent validation across product lines is
driving awareness and creating entirely new potential market opportunities based
on this level of performance.
•
The Company
received U S Food and Drug Administration (FDA) market clearance of RAMP
Troponin I and CK-MB tests enabling the commerciommercialization of its
lead clinical products for the early diagnosis of heart attack, or acute
myocardial infarct (AMI).
Moreover,
the peer-reviewed and broad publication of the RAMP Troponin I Test results
from multi-centerr US clinical trials demonstrated significant performance
improvement overr the leading competitive Point-of-Care (POC) system.
•
The
RAMP
Anthrax Test became the only approved assay following an 18-month
US Department of Homeland Security (DHS)/AOAC comprehensive evaluation
of five commercially available rapid tests.
•
The US
Centers for Disease Control (CDC) published research demonstrating the
RAMP West Nile Virus Test is the most accurate rapid on-site environmental
test on the market with 100-fold improvement in sensitivity over the competition.
These results and other third-party
research unequivocally show RAMP has overcome the performance limitations of
early generation POC immunoassays to produce highly sensitive and accurate,
lab quality results in minutes. This has positioned RAMP as the performance
leader in our current market segments, resulting in an increase in revenue from
product sales in 2003 of 157%. During 2004, revenues increased across all three
of the Company's product lines, reflecting growing acceptance of the Company's
products in its second full year of product sales. Specifically, revenues from
product sales for the year were $2,127,196 as compared to $827,795 for
the year ended December 31, 2003.
Response is now prominently
on the radar screen of leading international life science and healthcare companies,
and potential marketing partners exploring development and commercialization
collaborations. This is evidenced by the following initial new collaborations:
•
Shionogi
& Co. is funding development of a BNP (B-type natriuretic peptide)
test on RAMP for the congestive heart failure testing market in Japan;
•
3M
Medical Division is funding development and intends to market a line of
clinical infectious disease tests using the RAMP platform, and
•
General
Dynamics is integrating RAMP into its biological detection technology
for military and homeland security agencies worldwide.
The challenge and opportunity
in 2005 is to move beyond development agreements to ratify commercialization
agreements with our current partners, and conclude additional collaborations
that enhance the Company's product portfolio and its marketing and distribution
network internationally. These critically important relationships are expected
to importan facilitate increasing revenue in 20052 and beyond, further positioning
RAMP as the world's leading POC immunoassay platform.
Clinical Sales and
Marketing Strategy
Based on the establishment of the outstanding sensitivity and accuracy of the
Company's RAMP Troponin I Test and the strategic business development opportunities
that ensued, senior management recognized that RAMP had achieved the required
performance to become the POC platform of choice for rapid cardiovascular testing.
We elected to refrain from
entering into marketing and distribution agreements with a compliment of potential
distributors for the three FDA cleared RAMP Cardiac Marker Tests. Instead, we
made the prudent business decision to evolve our clinical sales and marketing
plans to capitalize on a significantly stronger and far-reaching distribution
network for an expanded cardiovascular line. Although foregoing some initial
revenue from cardiac test sales, parallel negotiations for these same jurisdictions
are underway with other third parties and involve both new proprietary tests
and overarching marketing possibilities.
Negotiations with multiple
potential partners are continuing. We are confident that the outcome will have
a profound positive impact on future potential revenue from product sales, and
the corresponding valuation of the Company.
Another indicator of RAMP's
competitive advantages is evidenced by the Company's ability to attract Dr.
Michael Groves, former Vice President, International Sales with Abbott POC and
i-STAT, as the new Vice President, Sales and Marketing. With more than 25 years
of direct diagnostic industry experience spent pent developing and co commercializing
POC diagnostics, Dr. Groves is strategically managing the Company's worldwide
sales program, while enhancing w the distribution network to further heighten
commercial interest and facilitate rapid marketma adoption of current and future
RAMP products.
•
In the
United States, we have implemented a hybrid sales approach - a combination
of direct sales into the high volume hospital segments to be supplemented
by distribution into the large number of lower volume facilities.
•
Dr. Groves
is leading the initial clinical sales team of high caliber US-based senior
sales associates, selling directly to strategic customers and importantly,
preparing to support distributors and marketing partners.
•
With regulatory
clearance of the Company's lead cardiovascular tests in the US, Canada,
China and much of Europe, we anticipate significant revenue growth from
this product line through 2005 and well beyond. As an example, Response
has already sold over 145 clinical RAMP Systems in China to its exclusive
distributor, O & D Biotechnology.
Congestive Heart Failure
(CHF) Testing Program
The Company is leveraging heightened recognition of RAMP's lab quality performance
to solidify strategically advantageous long-term relationships with capable
partners to expand the clinical product portfolio.
BNP and NT-proBNP are widely
recognized as definitive tests for diagnosing CHF, with a market potential approaching
US$1billion. CHF affects nearly 17 million people worldwide, and is the
single most frequent cause of hospitalization in people over 65 years. There
are currently five commercially available BNP systems, four of which are performed
on lab analyzers, and two NT-proBNP lab tests.
BNP
Program For CHF In Japan
The results to date from the BNP development program funded by
Shionogi & Co. provide confidence that the RAMP test will be rapidly
adopted once it becomes the only commercially available POC BNP test in
Japan.
The Company anticipates
the RAMP Cardiac Marker Tests for detecting heart attacks and the RAMP
BNP test will be introduced in Japan during the first quarter 2006.
CHF Worldwide
•
The collaboration
with Shionogi has also positioned RAMP as a leading candidate for companies
that have CHF markers but no POC delivery vehicle.
•
Response
continues working toward ratifying an agreement that would enable the
Company to commercialize a RAMP BNP Assay, not only in Japan, but worldwide.
•
In parallel,
the Company has also recently entered into third party discussions with
another leading internationall diagnostics company exploring development
and commercialization opportunities for NTT-proBNP.
While we assess broader reaching
marketing options for an expande panded clinical product portfolio, we are encouraged
by the progress to date and appear to be in the later stages of solidifying
critically important commercialization agreements for worldwide market arketing
and distribution.
Biodefense
Product Line
•
The RAMP
Anthrax Test has the exclusive distinction of being the only rapid biological
detection system to be lab tested and formally approved for use by AOAC
International. This followed a comprehensive 18-month evaluation of five
commercially available anthrax field tests, funded by the US DHS. Although
expected, this is yet another important source of third party validation
of RAMP's market-leading performance that is positively impacting product
sales.
•
Subsequently,
the Company received a US$250,000 purchase order from a group funded
by DHS with a mandate to train first responders throughout the US.
Response Biomedical
Corp.
-2-
Biodefense Product Line
(cont'd.)
•
Although the Company is not at liberty to disclose
particulars, the collaboration with General Dynamics (GD) aimed at integrating
the company's respective biological detection and identification technologies
is progressing well. A fully functional prototype has been demonstrated
and GD is now competing with one other company for the first military
contract for the integrated system.
Environmental West Nile Virus
•
The Company is making considerable progress commercializing
the West Nile Virus Test through its sole US distributor, Adapco Inc,
the largest supplier of mosquito control products in the US. This is particularly
supported by the publication of an evaluation by the US CDC showing it
is fully 100 times more sensitive than the competition. Having captured
approximately 20% percent of the total US mosquito control testing market
in the first full year of sales, we anticipate further increasing our
market share during the upcoming season.
•
In April, we had the privilege of hosting more than
100 leading experts and delegates from around the world at Response headquarters
from the American Mosquito Control Association Trustees meeting in May.
Clinical Infectious Disease Market
Clinical infectious disease prevention and detection includes new product candidates
in a broad array of priority areas such as sexually transmitted diseases, Streptococcus
(Strep), Staphylococcus (Staph), Influenza (Flu) and related bacterial and viral
infections.
Conventional diagnosis of infectious diseases is time intensive,
and prohibits immediate intervention and early treatment. Clinical infectious
disease testing at the Point-of-Care is expected to improve patient outcomes
by enabling physicians to make informed medical decisions rapidly. The evidence
continues to mount that RAMP's performance improvement over classic POC visual
assays provides a tremendous opportunity in this area.
3M Infection Screening Test
•
The development program is a co-development agreement
with 3M's Medical Division aimed at developing a new rapid, point-of-care
microbiology test in the area of infection prevention.
•
3M Medical Division is part of a world class company
with an extraordinary ability to develop and commercialize promising new
technologies. 3M Health Care is a recognized leader in infection prevention
and this collaboration is aimed at broadening its core competency to include
rapid identification at the POC.
•
The companies intend to enter into a further supply
agreement whereby Response Biomedical will manufacture and 3M will exclusively
market a line of microbiology tests.
•
This unique combination of technology and expertise
in infectious disease testing will help us introduce a broader product
portfolio to enhance patient outcomes and improve productivity for physicians
and health care providers.
Agri-Food Test
•
After completing Phase II development of a rapid
quantitative RAMP Biotech Test, the international biotechnology company
funding the program recently purchased 10 RAMP Systems for evaluation.
This project is designed to identify biotech traits in harvested grain,
and represents the Company's lead entree into the agricultural food and
grain testing market.
Fiscal 2004 Financial Results
Total revenues for 2004 were $2,676,881, more than double 2003 revenue of
$1,283,753. Total revenues for the fourth quarter were $456,493, compared
to $377,443 for the corresponding period in 2003.
For 2004, biodefense product sales were $879,637, representing
a 55% annual increase; clinical cardiac product sales were $506,475, representing
a 197% annual increase; and West Nile Virus product sales were $741,084,
representing an annual increase of 731% in the first full year of sales of this
test.
The Company recorded a net loss of $4,938,975 or eight
cents per share for fiscal 2004, compared with a net loss of $4,191,602
or nine cents per share for the year ended December 31, 2003.
Having achieved more than 100 percent revenue growth compared
with its first full year of sales in 2003, the Company is well positioning for
greater revenue in 2005 and higher revenue growth beginning next year. This
is primarily attributable to a growing referenceable clinical customer base
and the anticipated market introduction of additional products.
The Company's financial statements, management's discussion
and analysis of financial condition and results of operations for the fiscal
year ending December 31, 2004 are now available on SEDAR at www.sedar.com.
Corporate Finance
During 2004, the Company completed two private placements raising net proceeds
of $5,409,927. In addition, a further $3,251,250 in cash was obtained
through the issuance of shares related to the exercise of warrants and options.
As at December 31, 2004, the Company had working capital of $3,121,194,
no debt on its balance sheet, and a US$1,000,000 line of credit fully available
for use to Dec 15, 2005.
Although the Company is sensitive to concerns about dilution,
given the performance and revenue potential for RAMP products in several large
market opportunities, proceeds from these financings were a necessary and expeditiously
administered investment in the future of this Company.
In closing, I would like to welcome Mr. Sidney Braginsky,
former President of Olympus America Inc, to the Company's Board of Directors;
Mr. Robert Pilz, who re-joined the Company as Chief Financial Officer and Vice
President, Finance; and Dr. Michael Groves, our US-based Vice President, Sales
and Marketing. I would also like to acknowledge Haywood Securities for its continued
support, particularly as we prepare for a US quotation and listing. Most importantly,
on behalf of management and staff, I would like to acknowledge your continued
support at this time of extraordinary opportunity.
With hundreds of distinct immunoassay-based tests currently
performed on centralized lab analyzers, RAMP has demonstrated sufficient performance
to enable the transition of these tests from the lab to the POC. Further, entirely
new POC applications are emerging in other large potential market opportunities
by virtue of superior performance. With validated performance advantages over
market leading competitors in each of the areas it is commercializing product,
the Company is well positioned for significant near-term revenue growth and
long-term commercial success.
Sincerely,
Bill Radvak
President & Chief Executive Officer
April 29, 2005
-3-
Response Biomedical
Corp
RAMP
TECHNOLOGY
RAMP
®
(Rapid Analyte Measurement Platform) is a platform diagnostic system that can
be adapted to accurately quantify virtually any immunologically active substance.
The patented RAMP technology enables
the system to detect and quantify concentrations of analyte in approximately
15 minutes at sensitivities similar to centralized lab systems.
The RAMP System combines a proprietary
internal control and fluorescence technology to improve upon the performance
of earlier generation immunoassays. At the same time, it meets the demand for
rapid turnaround time, portability and ease-of-use.
The System consists of two components:
a disposable Test Cartridge that houses an analyte-specific immunochromatographic
strip, and a portable fluorescence-based Reader.
A
sample is applied to the sample well of the Test Cartridge The fluid sample
migrates along the strip. Fluorescent-dyed latex particles coated with antigen-specific
antibodies bind to antigen present in the sample. The sample, along with bound
and unbound latex particles, is transported by capillary action along the strip
to the Detection Zone.
The Detection Zone contains a second
antibody specific to the target analyte. If the fluid sample contains the target
analyte, it is captured by the antibody in the Detection Zone arresting the
migration of the attached latex particles.
If no target analyte is present,
the latex particles migrate past the Detection Zone.
The concentration of analyte located
at the Detection Zone is directly related to the concentration of target analyte
in the sample.
RAMP’s patented Internal
Control is run and measured concurrently in every assay allowing RAMP to compensate
for test-to-test and Reader-to-Reader variations. RAMP also utilizes fluorescence
providing an inherent increase in sensitivity of approximately 100 times greater
than visually read tests.
The RAMP Reader measures fluorescence
emitted by the complexes in the Detection and Internal Control Zones and calculates
a Ratio between these measurements. The RAMP Ratio effectively measures and
factors out the inherent variability that has limited the commercial application
of all other lateral flow rapid POC immunoassays.
Response Biomedical
Corp.
-4-
CLINICAL
Cardiovascular Testing
In clinical applications, the RAMP System is
designed for use by healthcare professionals at the Point-of-Care (POC), including
physicians’ offices, medical clinics, hospital emergency departments and
laboratories worldwide. RAMP provides a quantitative result in less than 15
minutes, compared to several hours or more for traditional laboratory testing.
Cardiac Marker Tests
Cardiac markers are proteins released in the
blood following a heart attack. Myoglobin, troponin I and CK-MB are the three
most commonly utilized markers measured to assist in the diagnosis of heart
attack or acute myocardial infarction (AMI), a leading cause of death worldwide
Rapid diagnosis of AMI is critical to patient outcomes. Every minute that passes
after the occurrence of a heart attack without medical treatment reduces the
patient’s chance of survival.
CE Mark and Quality Management
System is registered to ISO 13485: 1996 and ISO 9000: 2000
In May, the Company received 510(k) regulatory
clearance from the US Food and Drug Administration (FDA) to market two additional
RAMP Cardiac Marker Tests for detecting troponin I and CK-MB to assist in the
rapid diagnosis of heart attack. The Company previously received FDA clearance
of the RAMP Reader for general clinical use, and the RAMP Myoglobin Assay. In
August, the Company received similar clearance from Health Canada's Therapeutic
Products Directorate.
The US market alone for POC cardiac marker tests in 2004 was estimated
to be approximately $150 million. The world cardiac rapid assay market is
expected to achieve an average annual growth rate of 20 – 25 percent for
the near future. Each year in the United States, approximately eight million
Americans are admitted to emergency rooms for severe chest pain associated with
suspected AMI. Only approximately 10 percent of those hospitalized are subsequently
determined to have suffered a heart attack. The majority is eventually diagnosed
with strained muscles, bruises or heartburn. The total cost of unnecessary admissions
and misdiagnosis is over US$4 billion. Misdiagnosed heart attack cases also
account for nearly 25 percent of malpractice claims against emergency room physicians.
In January, 2005 the Company announced that the RAMP Reader and
three RAMP Cardiac Marker Tests have received regulatory clearance in China
from the State Food and Drug Administration (SFDA). The Company has sold approximately
145 Systems to its exclusive distributor in China, O&D Biotechnology Co.
China is the largest and fastest growing medical
device market in Asia. With an aging population, a rising standard of living,
and the Government's commitment to improve access to basic health care, China
is emerging as one of the single most important markets internationally. With
over 1.2 billion people, China has more than 300,000 health institutions including
more than 65,000 largely government-run hospitals. Chinese hospitals provided
more than 900,000 beds and treated more than 2 billion patients in 2000. According
to U.S. census data, electro-medical diagnostic and imaging equipment lead exports
in the category of medical equipment to China. The market size for this segment
is estimated at $2.5 - $3 billion, of which $1.3 - $1.4 billion
are imports.
To date, the Company has received market clearance
for its lead cardiovascular products in each of the following juristictions:
US, Canada, China, Russia, United Kingdom, Netherlands, Denmark, Finland, Greece,
Germany, Italy, Norway, Spain, and Sweden. Regulatory submissions are under
review in additional markets.
Peer-Reviewed and Published Clinical Trial
Results
This study has demonstrated that the RAMP whole-blood
POC testing device had acceptable analytical characteristics and similar sensitivity
and specificity for AMI detection to be an acceptable alternative to an automated
central laboratory-based instrument (Dade Dimension RxL) and an established
FDA-cleared POC testing device for monitoring cardiac biomarkers . . .
1
.
1.
A.H.B. Wu et al. / Clinical Chimica Acta
346 (2004) 211-219.
Available on-line at www.responsebio.com.
Correlation of RAMP cTnI and
Dade Dimension RXL cTnI
Samples (n=364) were tested in RAMP cTnI and Dade Dimension cTnI
RAMP troponin I test delivers <10% CV at o.2 ng/ml with an LLD of 0.03 ng/ml
The RAMP System has overcome the performance
limitations of early generation POC immunoassays to produce highly sensitive
and accurate, lab quality results in minutes, anywhere, every time.
-5-
Response Biomedical
Corp
CLINICAL
Congestive Heart Failure and BNP
"Since 2000 when the first
assay for B-type natriuretic peptide (BNP) received clearance from the Food
and Drug Administration (FDA), this test has become a "blockbuster" hit for
both ruling out and for diagnosing congestive heart failure (CHF). In my 24
years in clinical chemistry, few assays have taken on such a prominent role
so quickly in the management of patients."
Fred S. Apple,
PhD, Clinical Laboratory News, February 2005
Congestive heart failure (CHF) affects nearly
17 million people worldwide, and is the single most frequent cause of hospitalization
in people over 65 years. According to the American Heart Association, approximately
5 million Americans are currently afflicted with CHF and 550,000 new cases are
diagnosed each year. An estimated US$23.7 billion will be spent caring for
current CHF sufferers. The prevalence of CHF is expected to continue increasing
due to the aging population and improved survival rates of patients with other
cardiovascular diseases. The initial diagnosis is problematic as symptoms are
non-specific and can be associated with other pathologies such as respiratory
disease and the secondard effects of obesity.
Elevated levels of BNP indicate the presence
of heart failure, and provide physicians with an important diagnostic tool in
the early detection and management of CHF. The annual market for BNP testing
is estimated to be approaching US$1 billion, with significant growth expected
due to the increasing rate of adoption by the international medical community.
BNP testing is gaining widespread acceptance as a routine procedure in the monitoring
of patients with heart failure. Numerous clinical trials are exploring other
cardiovascular applications, including acute coronary syndromes and heart surgery
eligibility and prognosis.
BNP is secreted into the bloodstream by the
heart in response to ventricular hypertrophy and pressure overload. BNP acts
to relieve the pressure. Clinical trials have demonstrated that rapid BNP testing
in the emergency department can reduce hospital admissions, total treatment
time and treatment costs. It has also been demonstrated that a single, point-of-care
BNP test performed immediately upon arrival at the emergency department provided
greater diagnostic accuracy than a clinician using historical data, physical
examinations, conventional laboratories and chest x-rays.
BNP For Japan
In October, the Company entered into a collaboration with Shionogi & Co
Ltd., a leading Japanese pharmaceutical company, to develop a rapid quantitative
RAMP test for BNP, a proprietary cardiovascular marker test to assist in the
diagnosis and management of congestive heart failure. Response Biomedical is
developing the new RAMP BNP Test for Shionogi, which has exclusive rights to
BNP in Japan. Shionogi is funding development and will be responsible for regulatory
affairs, marketing and distribution of the RAMP BNP Test in the Japanese market.
This development agreement for a BNP test is
a significant first step in broadening the Company’s clinical product
portfolio. This Point-of-Care BNP test is expected to find strong market acceptance
in Japan and enhance revenue from sales of the three FDA-cleared RAMP Cardiac
Marker Tests.
Shionogi & Co., Ltd, headquartered in Osaka,
recorded total net sales for fiscal year ended March 31, 2004 of approximately
US$1.82 billion. Operating divisions are focused on pharmaceuticals, diagnostics,
industrial chemicals and capsule business. Shionogi has marketed SHIONORIA BNP
in Japan since 1994 as diagnostics and in Europe since 1997 as reagents for
research use by medical doctors and laboratory investigators.
CHF Worldwide
BNP and NT-proBNP tests are both used to diagnose CHF, a market potential of
US$1billion. There are currently five commercially available BNP systems,
four of which are performed on lab analyzers, and two NT-proBNP lab tests.
The Company is exploring development
and commercialization opportunities for POC BNP and NT-proBNP diagnostics worldwide.
Clinical Infectious Disease Testing
In November, 2004, Response Biomedical Corp.
and 3M Company through its Medical Division, announced that the two companies
have entered into a co-development agreement whereby 3M will fund the development
of a new rapid, point-of-care microbiology test in the area of infection prevention
based on Response Biomedical's RAMP technology. The parties intend to enter
into a further supply agreement whereby Response Biomedical will manufacture
and 3M will exclusively market a line of microbiology tests.
Conventional diagnosis of infectious diseases
is time intensive, and prohibits immediate intervention and early treatment.
Clinical infectious disease testing at the Point-of-Care is expected to improve
patient outcomes by enabling physicians to make informed medical decisions rapidly.
3M Health Care, the largest of seven major
3M businesses, is dedicated to improving the practice, delivery and outcome
of care in medical, dental, pharmaceutical, health information and personal
care markets. 3M Medical Division, part of the 3M Health Care family, is a leader
in medical supplies, with expertise in infection prevention and skin health.
Response Biomedical
Corp.
-6-
BIODEFENSE
RAMP
Sets New Standard for Rapid Anthrax Detection
In November, 2004, following an 18 month rigorous
independent evaluation funded by the US Department of Homeland Security (DHS),
Response's RAMP Anthrax Test became the only rapid biological detection system
to meet the new performance standards introduced by AOAC INTERNATIONAL for rapid
immunoassay-based anthrax detection systems.
The RAMP Anthrax Test is now laboratory tested
and approved as both an AOAC Performance Tested Methods
SM
(PTM)
and Official Methods of Analysis
SM
(OMA), the "gold standard" of
methods accepted and recognized by regulatory agencies and organizations worldwide.
Background
Shortly after September 11th terrorist attacks,
the US was faced with an outbreak of anthrax. In order to protect public health
and safety from bioterrorism, in June of 2003, the Department of Homeland Security
partnered with AOAC INTERNATIONAL to evaluate commercially available methods
for detectingB. anthracis (BA).
A task force was formed that included a broad
array of representatives to help in the selection of the methods and design
of the studies. This consisted of approximately 50 experts on BA, assay development,
validation study design, and statistics from 36 federal and 9 military agencies,
(including DHS, FDA, HHS/CDC, USDA, USPS, FBI), and representatives of state
and municipal agencies, academia, and first responder units.
Five rapid immunoassay-based anthrax field
tests have undergone comprehensive validation through the AOAC harmonized Performance
Tested Methods
SM
program, which provides an independent third-party
review of test kit performance claims. RAMP has the exclusive designation of
being the only commercially available system to meet the new standards for rapid
and reliable anthrax detection.
In studies designed by AOAC scientists and
implemented at U.S. Army, Dugway Proving Ground in Utah, RAMP was demonstrated
to reliably detect Bacillus anthracis isolates representing a wide variety of
geographic sources and physical variants. The specificity of RAMP was also demonstrated
in evaluations to confirm that it would not cross react with non-Bacillus anthracis
bacteria. To judge the accuracy of the data generated, AOAC organized 12 laboratories
nationwide to assess RAMP's performance using identical samples. The RAMP test
performed well in the collaborative study, and little variation was seen in
the data produced by the 12 laboratories.
AOAC INTERNATIONAL is a 120 year-old not-for-profit
scientific association committed to worldwide confidence in analytical results.
With more than 3700 members, AOAC has global brand recognition.
Anthrax (Bacillus anthracis
)
COMPANY
KIT NAME
RECOGNITION
Tetracore Technologies
BTA Test Strip for Anthrax
none
New Horizon Diagnostics
Biowarfare Anthrax Kit
none
Pro-Lab Diagnostics
Bacillus anthracis
none
Response Biomedical
RAMP Anthrax Test Cartridge
AOAC Official Method;
Performance Tested Method 070403
VRG Technologies Inc.
Environmental
Anthrax Test Kit
none
MIDI, Inc.
MIDI Sherlock Microbial
Identification System
AOAC Official Method
Data Source: AOAC INTERNATIONAL. Note: MIDI is
a confirmatory lab analyzer
"AOAC INTERNATIONAL
uses a time tested and exceptionally rigorous process in evaluating analytical
methodology. The RAMP System performed well in this rigorous evaluation, and
that says quite a lot about it. AOAC and DHS are working rapidly to ensure that
the RAMP System will be a very useful tool for first responders."
Mr. James Bradford,
PhD,
Executive Director, AOAC International
US First Responders Training on RAMP
The Company received its single largest purchase
order to date from a DHS sponsored program that has a mandate to train first
responders throughout the US.
The Domestic Preparedness Equipment Technical
Assistance Program (DPETAP) is a comprehensive, national equipment technical
assistance program for emergency responders, established by the Office for Domestic
Preparedness in partnership with the United States Army's Pine Bluff Arsenal,
the Department of Defense's center of expertise for chemical and biological
defensive equipment production and support.
Internationally, Response has 16 distributors
in the US, Israel, Europe, Asia, Australia and the Middle East. The Company
has sold more than 200 biodefense systems to discerning customers in the public
and private sectors throughout the world.
General Dynamics
The Company is pleased with the continued progress
in its collaboration with General Dyanmics Canada Ltd., a business unit of General
Dynamics Corp. The program is aimed at integrating RAMP technology into General
Dynamics’ 4Warn System to meet the real-time biological agent surveillance
needs of the military and homeland security agencies worldwide.
Only RAMP meets
new standards for
rapid anthrax detection
-7-
Response Biomedical
Corp
WEST
NILE VIRUS
The RAMP West Nile Virus (WNV) Test is a highly
sensitive pre-screening test used for identifying WNV in mosquitoes and corvids.
RAMP is used by public health laboratories, veterinary diagnostic laboratories,
universities and mosquito control districts.
The Company’s sole US distributor, Adapco
Inc., captured approximately 20% percent of the total US mosquito control testing
market in the first full year of sales. Adapco is the largest supplier of mosquito
control products in the US.
The performance of the RAMP WNV Test has been
validated by five independent external studies, including evaluations conducted
by the US Centers for Disease Control and Prevention (CDC) and the Canadian
National Microbiology Lab.
These results confirm in-house data and demonstrate
that the RAMP WNV Test has >76% sensitivity and 100% specificity in comparison
to PCR-based lab analyzers, and >96% correlation to ELISA. The US CDC and
Health Canada evaluation
1
also confirmed that RAMP is approximately
100 times more sensitive that the competitive rapid WNV test.
1.
Evaluation of Commercial Assays for
Detecting West Nile Virus Antigen, K.L. Burkhalter, R. Lindsay, R. Anderson,
A Dibernardo, H. White, M. Drebot, W. Fong, R. Nasci
The American Mosquito Control Association
(AMCA)
In April 2005, more than 100 delegates attending
the American Mosquito Control Association Trustees meeting in Vancouver, visited
Response headquarters for RAMP demonstrations, presentations and a tour of the
facility.
The American Mosquito Control Association,
founded in 1935, is a scientific/educational, not-for-profit public service
association, with members or subscribers to its publications in over 50 countries.
About West Nile Virus
There are no vaccines available to prevent
infection, and no drugs to treat the virus. The public health strategy rests
squarely on the early detection of the virus in mosquitoes and birds, enabling
eradication of the carriers to prevent human transmission.
In 2004, the US CDC recorded 2,470 reports
of human cases of West Nile. Of these, 900 (36%) were reported as West Nile
meningitis or encephalitis (neuroinvasive disease), 1017 (41%) were reported
as West Nile fever (milder disease), and 553 (22%) were clinically unspecified
at this time.
The virus is permanently established in the
US, and its progression is well documented.
Progression
of West Nile Virus in the US
*
MANAGEMENT'S DISCUSSION
AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and
analysis should be read in conjunction with the audited consolidated financial
statements of the Company for the year ended December 31, 2004, including the
related notes therein. Our audited consolidated financial statements have been
prepared in accordance with Canadian generally accepted accounting principles
("GAAP"). A reconciliation to U.S. GAAP is presented in note 16 of our audited
consolidated financial statements included herein. This discussion includes
forward-looking statements made by management that involve uncertainties and
risks, including those discussed herein and as described in the "Risk Factors"
section of our Annual Information Form. Such forward-looking statements should
be given careful consideration and undue reliance should not be placed on these
statements. Our actual results may differ materially from those contained in
any forward-looking statements. Additional information relating to our company,
including our 2004 Annual Information Form, is available by accessing the SEDAR
website at www.sedar.com. All amounts are expressed in Canadian dollars unless
otherwise indicated.
This management discussion
and analysis of financial condition and results of operations has been prepared
as at April 29, 2005.
OVERVIEW
Response Biomedical Corp. ("Response Biomedical" or "the Company") develops,
manufactures and sells diagnostic tests for use with its proprietary RAMP
®
System, a fluorescent immunoassay-based on-site diagnostic testing platform.
The RAMP technology utilizes a unique method to account for sources of error
inherent in conventional lateral flow immunoassay technologies, thereby providing
the ability to quickly and accurately detect and quantify an analyte present
in a liquid sample. Consequently, an end user on-site or in a point-of-care
setting can rapidly obtain important diagnostic information. Response currently
has nine RAMP tests available for environmental and clinical (health) testing
applications and the Company has plans to commercialize additional tests.
The Company achieved significant
progress on a number of fronts during 2004:
Revenues increased in all three
of the Company's product market segments, namely clinical, (2004 - $506,475,
2003 - $170,781), biodefense (2004 - $879,637, 2003 - $567,872)
and environmental infectious diseases, including West Nile Virus (2004 - $741,084,
2003 - $89,142). The increases reflected growing acceptance of the Company's
products in its second full year of product sales and first full year of sales
of the RAMP West Nile Virus Test.
Revenue also increased from
contract service fees, with revenue generated from a number of significant collaboration
contracts and agreements (2004 - $549,685, 2003 - $455,958).
The Company improved its financial
position, which included a cash balance of $2,716,902 as at December 31,
2004. As at December 31, 2004, a U.S.$1,000,000 line of credit was also
fully available, which must be repaid by December 15, 2005. As at December 31,
2004, the Company had working capital of $3,121,194 and no debt.
During 2004, the Company closed
two private placements raising net proceeds of $5,409,927. In addition,
a further $3,251,250 in cash was obtained through the issuance of shares
related to the exercise of warrants and options.
Additional significant milestones
include:
•
In April
2004, the Company achieved ISO Certification to ISO 13485: 1996 for its
Quality Management System.
•
In June
2004, the Company initiated a second phase of development of a biotechnology
trait detection test for grain, funded by a leading international biotechnology
company.
•
The Company
received final clearance to market the Company's Troponin I and CK-MB
cardiac marker tests in the United States (May 2004), Canada (August 2004),
European Union (nine countries; August 2004), China (January 2005), and
Russia (January 2005).
•
In October
2004, the Company announced and commenced a collaboration agreement with
a leading Japanese company, Shionogi & Co., Ltd., for the development
of a RAMP BNP test for congestive heart failure, to be marketed and sold
in Japan.
•
In November
2004, the Company announced and commenced a collaboration agreement with
3M Co. to develop a RAMP clinical infectious disease test to be manufactured
by Response Biomedical and marketed and sold by 3M should the companies
enter into a further supply agreement.
•
In November
2004, to drive sales of the Company's clinical products, the Company hired
Dr Michael Groves as its Vice-President Sales and Marketing, and subsequently
hired an experienced team of five U.S.-based sales managers. Dr. Groves
was formerly Vice-President of International Sales and Marketing for both
Abbott Point of Care and I-STAT Corp.
•
In November
2004, the RAMP Anthrax test was recognized as the only rapid biological
detection system to meet the new performance standards introduced by AOAC
International following and independent valuation that was funded
by the U.S. Department of Homeland Security.
RESULTS OF OPERATIONS
For the Years ended December 31, 2004 and 2003
Revenue and Cost of
Sales
Revenues from product sales for the year ended December 31, 2004 were $2,127,196
as compared to $827,795 for the year ended December 31, 2003, an annual
increase of 157%. For 2004, biodefense product sales were $879,637 as compared
to $567,872 in 2003 representing a 55% annual increase, The increase in
biodefense product sales was primarily due to increasing in recurring revenues
from a growing customer base and growing acceptance of the Company's products
following additional independent performance validation. Clinical cardiac product
sales were $506,475 compared to $170,781, representing a 197% annual
increase. The increase in clinical cardiac product sales was primarily attributable
to sales in the Chinese market. Sales of the Company's West Nile Virus products
were $741,084 compared to $89,142 in 2003, representing an annual increase
of 731% in the first full year of sales of this test.
Revenues from contract service
fees and collaborative research agreements for the year ended December 31, 2004
were $549,685 as compared to $455,958 for the year ended December 31,
2003 representing an annual increase of 21%. A main component of the 2004 revenue,
$255,250, was for a Maritime Biological Detection System developed for General
Dynamics Canada Ltd, aimed at integrating the RAMP system into General Dynamic's
4WARN biological agent surveillance system.
Cost of sales for the year
ended December 31, 2004 was $1,304,447 compared to $730,967 for the
year ended December 31, 2003. This increase reflects the Company's increased
sales. Cost of sales includes direct manufacturing labour and materials costs,
and allocated overhead.
Gross margin for the year ended
December 31, 2004 was 51% compared to 43% for the prior year. Improved manufacturing
efficiency was attained during 2004 as a result of the company's increased production
and process improvements. Going forward, we expect gross margin to benefit from
improved economies of scale and further process improvements as the Company
scales up and automates its manufacturing operations.
Expenses
Research and development expenditures for the year ended December 31, 2004,
increased to $2,215,614 from $2,153,828 for the year ended December
31, 2003, an increase of 2.8% . The increase reflects increased product validation,
product enhancement and testing costs ($240,000), increased patent study
and search costs ($109,000) offset by reduced professional fees and other
external costs relating to clinical trials of RAMP CK-MB and High Sensitivity
Troponin I tests ($98,000) which were completed during 2003; with the remainder
of the offsetting decrease ($189,000) largely due to reduced allocation
of rent, leasehold improvement and other overhead costs in 2004 as a result
of research and development making up a smaller proportion of the Company's
operations.
Marketing and business development
expenses totaled $1,657,318 during the year ended December 31, 2004 as compared
to $852,486 for the same period in 2003, an increase of 94%. The increase
was due to higher payroll and benefit costs, related primarily to the addition
of sales and marketing staff ($367,000) including five U.S. based sales
managers and Vice President of Sales, the implementation of a revenue based
commission plan ($50,000), and recruitment costs related to building an
effective sales and marketing department for the clinical market ($96,000).
Advertising and promotion costs for marketing the Company's biodefense and West
Nile Virus products were higher in 2004 in order to build customer awareness
in the North American market ($108,000).
General and administrative
expenses increased to $1,443,707 for the year ended December 31, 2004, from
$1,210,118 in the same period in 2003, an increase of 19%. This change was
primarily the result of increased professional audit and legal services relating
to the Company's registration with the U.S. Securities and Exchange Commission
in preparation for listing on a U.S. stock exchange or quotation system, and
expenses required to support improved corporate communications activities.
Other Income/Expenses
For the year ended December 31, 2004, the Company recorded non-cash stock-based
compensation of $814,682 compared to $136,918 for the year ended December
31, 2003. This expense represents the fair value of stock options granted using
the Black-Scholes option-pricing model. The higher charge is primarily related
to an increase in the number of options granted,
-9-
Response Biomedical
Corp
Other Income/Expenses
(cont'd)
(2004 - 3,282,700, 2003 - 1,086,300), largely due to an increase in the number
of employees from 35 at December 31, 2003 to 52 at December 31, 2004.
During the year ended December
31, 2004, interest expense including loan guarantee fees was $173,279 compared
to $407,343 for the same period in 2003. The interest expense in 2004 included
$5,791 (2003 - $6,481) relating to the 9% (2003 - 9%) per annum interest
paid on loans from shareholders and directors, $27,914 (2003 - $69,666)
relating to interest expense on the use of the line of credit facility, and
miscellaneous interest of $1,558 (2003 - $2,157).
Loss
For the fiscal year ended December 31, 2004, the Company reported a loss of
$4,938,975 ($0.08 per share) as compared to a loss of $4,191,602
($0.09 per share) for the fiscal year ended December 31, 2003. The increase
in loss is largely due to increased sales and marketing expenses incurred to
build the Company's customer base and sales funnel, mitigated by increased gross
margin from sales. The comparable loss per share was attributable to the increase
in outstanding shares at December 31 (2004 - 67,435,472; 2003 - 53,518,521).
SELECTED QUARTERLY INFORMATION FOR
2004 AND 2003
The table below sets forth selected data derived
from the Company's unaudited consolidated financial statements prepared in accordance
with Canadian generally accepted accounting principles for the eight previous
quarters ended December 31, 2004.
4
TH
Quarter
3
RD
Quarter
2
ND
Quarter
1
ST
Quarter
Total
2004
$
$
$
$
$
Total Revenue
456,493
657,753
753,499
809,136
2,676,881
Loss
(1,965,811)
(1,113,240)
(1,109,420)
(750,504)
(4,938,975)
Loss per share
Basic and Diluted
(0.03)
(0.02)
(0.02)
(0.01)
(0.08)
Total Assets
4,544,784
2,212,921
1,690,666
1,541,212
4,544,784
2003
Total Revenues
377,444
255,825
446,320
204,164
1,283,753
Loss
(1,072,434)
(1,172,724)
(893,120)
(1,053,324)
(4,191,602)
Loss per share
Basic and Diluted
(0.02)
(0.02)
(0.02)
(0.02)
(0.09)
Total Assets
1,181,334
1,070,806
1,214,004
1,062,166
1,181,334
Quarter to quarter variability and the general up-trend in revenues is driven
primarily by three factors:
1.
The timing of achievement
of services contract milestones and corresponding revenue recognition;
2.
Seasonality related
to the demand for RAMP West Nile Virus Tests where the majority of the
year's sales occur in the second and third quarters with commercial sales
of West Nile Virus products initiated in November 2003; and
3.
Generally increasing
market acceptance of the Company's products with 2004 being the first
full year of sales for West Nile Virus products, the second full year
for biodefense products and the initial launch of clinical products occurring
internationally in mid 2004.
The increase in total assets
in the fourth quarter relates to the closing of a private placement financing
in December 2004.
The trend in rising losses
is primarily the result of increasing sales and marketing expenditures, primarily
to develop the clinical sales funnel and a general increase in infrastructure
across all functions to support anticipated sales and partnering requirements.
SELECTED ANNUAL INFORMATION
FOR 2004, 2003, AND 2002
The following table sets forth
consolidated financial data for the Company's last three fiscal years:
2004
2003
2002
$
$
$
Total Revenue
2,676,881
1,283,753
189,208
Loss
(4,938,975)
(4,191,602)
(4,673,656)
Total Assets
4,544,784
1,181,334
862,500
Loss Per Share - Basic and
Diluted
(0.08)
(0.09)
(0.11)
Total Long-Term Obligations
(1)
-
-
-
Cash Dividends Declared
-
-
-
(1) The Company's long-term
liabilities in its financial statements represents deferred revenue and deferred
lease inducements.
LIQUIDITY AND CAPITAL
RESOURCES
The Company has financed its
operations primarily through equity and debt financings. To December 31, 2004
the Company has raised approximately $34.7 million from the sale and issuance,
net of share issue costs, of equity securities.
During the year ended December
31, 2004, the Company received net proceeds of $5,409,927 from the sale
of equity securities through private placement, as compared to $2,576,815
for the year ended December 31, 2003.
During the year ended December
31, 2004, the Company received net proceeds of $3,176,250 from the exercise
of warrants and stock options into shares, as compared to $677,149 for the
year ended December 31, 2003.
The Company's working capital
position as of December 31, 2004 was $3,121,194, an increase in working
capital of $4,716,633 from the 2003 deficit of $1,595,439, primarily
the result of closing an equity private placement in December 2004 at a price
of $0.75 per unit for gross proceeds of $2,933,750, before share issuance
costs of $318,449 resulting in net proceeds of $2,615,301. Additionally,
cash flow was negatively impacted primarily by an increase in inventories of
$449,831 in anticipation of cardiac product launch in the U.S.
During 2004, the Company incurred
a loss of $4,938,975 versus a net loss of $4,191,602 for the same period
in 2003. Until the Company receives additional revenue from product sales, it
will continue to fund its operations from a combination of the issuance of equity
securities, contract service fees, revenues from collaborative research arrangements,
use of its U.S.$1 million line of credit, and possibly additional debt financing.
As at December 31, 2004, the
Company has 6,335,917 outstanding warrants at exercise prices between $0.80
and $1.50 per share, which if fully exercised, would result in the receipt
of approximately $7.5 million. The Company also has 7,641,500 stock options
outstanding of which 5,627,352 are exercisable at prices between $0.27 and
$1.78 per share and which, if fully exercised, would result in the receipt
of approximately $3.1 million.
RISKS AND UNCERTAINTIES
Although Response Biomedical
believes that there will be a significant market opportunity for its diagnostic
products, the markets for rapid on-site and point-of-care diagnostic tests are
fragmented and still in their early stages of growth. Accordingly, there are
a variety of risks that the Company will face in order to be successful. Significant
efforts are being made by companies with greater resources than Response Biomedical
to develop competing technologies and products. The success of Response Biomedical
will depend upon the ability of the Company to demonstrate that the performance
of its products exceeds that of competing tests. Additionally where relevant,
the Company may be required to show that the results of its products are similar
to more expensive laboratory-based products. For clinical testing applications,
the Company requires a number of regulatory approvals to market its products,
the most important being approval by the United States Food and Drug Administration.
Although uncertain at this time, there may be likelihood that regulatory approvals
could be required at some point in the future for the Company's environmental
testing products. The market for the Company's products will also be influenced
by competing technologies and the success of the Company's business will be
highly dependent on the degree of protection provided by its intellectual property.
The Company must also obtain funding for the development and commercialization
of its products on reasonable terms and must compete for capital with firms
within the medical diagnostics industry as well as with firms in other sectors.
The recruitment and retention of personnel skilled in product development and
manufacturing is critical for the Company to achieve its objectives. The Company
attempts to reduce business and product development risk through a number of
different strategies, for example, the Company seeks to establish relationships
with strategic partners to assist in the development, funding and marketing
of some of the Company's products. This allows Response Biomedical to focus
on using its own resources to develop additional product candidates and exploit
new applications for its technology, further enhancing the number of product
opportunities available to the Company. Response Biomedical will also continue
to review and wherever practical, expand upon its intellectual property portfolio
to safeguard what the Company believes to be its technological competitive advantages.
The Company has had an ongoing
need to raise additional funds to continue conducting its research and development
programs and clinical trials, purchase capital equipment and commercialize its
products. There can be no assurance that such funds will be available on favourable
terms, or at all. If adequate funding is not available, the Company may be required
to delay, reduce or eliminate one or more of its research or development programs
or obtain funds through arrangements with corporate partners or others that
may require the Company to relinquish greater or all rights to product candidates
at an earlier stage of development or on less favourable terms than the Company
would otherwise seek. Insufficient funding may also require the Company to relinquish
rights to certain of its technologies that the Company would otherwise develop
itself.
Foreign Exchange and
Inflation
Financial risk is the risk to the Company's results of operations that arise
from fluctuations in interest rates and foreign exchange rates and the degree
of volatility of these rates. The Company is subject to foreign exchange risk
as substantially all its revenues are denominated in U.S. dollars. The Company
mitigates foreign exchange risk as it maintains U.S. dollar bank accounts that
are used to pay for expenses in U.S. dollars.
Response Biomedical
Corp.
-10-
Foreign Exchange and
Inflation
(cont'd)
Interest rate risk arises due to the Company's cash and cash equivalents being
invested in variable rate securities and the Company's loans having fixed and
variable interest rates.
MATERIAL COMMITMENTS
AND CONTRACTUAL OBLIGATIONS
As at December 31, 2004, the
Company had the following commitments and contractual obligations.
Commitments and Obligations
Total
<
1 Year
1 - 3 Years
4 - 5 Years
> 5 Years
UBC License Fee
$89,500
$16,000
$31,500
$21,000
$21,000
OFF BALANCE SHEET ARRANGEMENTS
The Company does not have any
material off balance sheet arrangements requiring disclosure.
OUTSTANDING SHARE CAPITAL
As at March 31, 2005 there
were 67,619,472 common shares issued and outstanding, 8,020,250 common shares
issuable upon the exercise of outstanding stock options at a weighted-average
exercise price of $0.61 per share, 845,213 common shares reserved for future
grant or issuance under our stock option plan and 6,335,917 common shares issuable
upon the exercise of outstanding warrants at a weighted average exercise price
of $1.19 per share.
TRANSACTIONS WITH RELATED
PARTIES
During the year the Company
paid a director, Mr. Dominique Merz, $15,522 for services rendered relating
to a private placement, and paid another director, Mr. Steven Holmes $5,000
for services rendered relating to a private placement.
During the financial year ended
December 31, 2003, the Company entered into an agreement with Katan Associates
International ("KAI") to provide strategic consulting services. Under the terms
of the agreement the Company pays KAI a monthly retainer of U.S.$5,000.
Mr. Stan Yakatan is the Chairman and Managing Partner of KAI and became a director
of the Company in February 2004. During the year ended December 31, 2004, the
amount incurred in these services amounted to $71,930 (2003 - $Nil).
During the year $180,279
in loans and outstanding interest was repaid to three directors: Dominique Merz,
William Radvak and Brian Richards.
CRITICAL ACCOUNTING
POLICIES AND ESTIMATES
The Company's significant accounting
policies are disclosed in Note 2 to the audited consolidated financial statements
as at December 31, 2004. The significant accounting policies we believe are
the most critical in fully understanding and evaluating our reported financial
results accounting policies and estimates include:
Revenue recognition
Product sales are recognized upon the shipment of products to customers
and distributors, if a signed contract exists, the sales price is fixed and
determinable, collection of the resulting receivables is reasonably assured
and any uncertainties with regard to customer acceptance are insignificant.
Sales are recorded net of discounts and sales returns. A provision for the estimated
warranty expense is established by a charge against operations at the time the
product is sold.
Contract service fees are recorded
as revenue as the services are performed pursuant to the terms of the contract,
provided collectibility is reasonably assured. Upfront fees from collaborative
research arrangements, which are non-refundable and require the ongoing involvement
of the Company are deferred and amortized into income on a straight-line basis
over the term of the relevant license or related underlying product development
period. Upfront fees from collaborative research arrangements that may be refundable
are deferred and recognized once the refundability period has lapsed. A significant
change in estimating the period of our on-going involvement could have a material
impact on our results of operation.
Research and development
costs
Research and development costs consist of direct and indirect expenditures
related to our research and development programs. Research and development costs
are expensed as incurred unless they meet generally accepted accounting criteria
for deferral and amortization. We assess whether these costs have met the relevant
criteria for deferral and amortization at each reporting date.
Stock-based Compensation
and other Stock-based Payments
All share-based awards be measured and recognized using a fair value
based method. The fair value of stock options is estimated at the date of grant
using the Black-Scholes option pricing model and is amortized over the vesting
terms of options which is generally three to five years from grant.
The Black-Scholes option pricing
model is based on several subjective assumptions including the expected life
of the option, the expected volatility at the time of the options are granted,
and the fair value of the Company's stock at the date of grant of the stock
options. Changes in these assumptions can materially affect the measure of the
estimated fair value of the Company's employee stock options, hence the Company's
results of operations.
CHANGES IN ACCOUNTING
POLICIES INCLUDING INITIAL ADOPTION
The Company has elected to
prospectively adopt the recommendations of the Canadian Institute of Chartered
Accountants (the "CICA") Handbook section 3870, Stock-Based Compensation and
Other Stock-Based Payments, for awards granted under its stock option plan to
executive officers, directors and employees, effective January 1, 2003. The
Company had adopted the recommendations, as required, for awards granted under
its stock option plan to non-employees. This standard and the amendments require
that all stock-based awards be measured and recognized using a fair value based
method. The fair value of stock options is estimated at the date of grant using
the Black-Scholes Option pricing model and is amortized over the vesting terms
of the stock options.
The Company was permitted to
and elected to prospectively apply the fair value based method of accounting
for stock based stock options granted to employees, officers and directors effective
January 1, 2003. Previously no compensation expense was recorded for stock-based
compensation awards to employees, officers and directors. The adoption of the
new recommendations resulted in an additional benefit expense of $82,000
in 2003 compared to nil in 2002 when the effect of the fair value method on
employee options was disclosed but not required to be recorded in financial
statements.
FINANCIAL INSTRUMENTS
Certain of the Company's financial
instruments, including cash equivalents, accounts and amounts receivable, accounts
payable, demand loans payable and loans payable to shareholders and directors,
the carrying amounts approximate fair values due to their short term nature.
The Company performs ongoing
credit checks on its customers and requires orders to be prepaid by certain
customers. As at December 31, 2004, five [2003 - four] customers represent 72%
[2003 - 60%] of the trade receivables balance.
Financial risk is the risk
to the Company's results of operations that arise from fluctuations in interest
rates and foreign exchange rates and the degree of volatility of these rates.
The Company is subject to foreign exchange risk given that approximately 61%
of total revenues for the year ended December 31, 2004 were received in U.S.
dollars. The Company minimizes this risk by maintaining a U.S. dollar account
for all U.S. sales revenues and expenditures, thereby minimizing currency exchange.
Fluctuating foreign exchange rates are reflected in the line of credit available
to the Company; however, the balance outstanding on the line of credit is not
subject to foreign exchange adjustments.
Interest rate risk arises due
to the Company's cash and cash equivalents being invested in variable rate securities.
-11-
Response Biomedical
Corp
MANAGEMENT'S RESPONSIBILITY
FOR
FINANCIAL REPORTING
The consolidated financial
statements contained in this annual report have been approved by the Board of
Directors, and were prepared by management using Canadian generally accepted
accounting principles. Management is responsible for the preparation and integrity
of the consolidated financial statements and all other information in the annual
report, and for ensuring that this information is consistent, where appropriate,
with the information contained in the consolidated financial statements.
Management has developed and
is maintaining a system of internal controls to obtain reasonable assurance
that the Company's assets are safeguarded, transactions are authorized and financial
information is reliable.
The Board of directors, through
the Audit Committee, is responsible for ensuring that management fulfils its
responsibilities for financial reporting and internal control.
The consolidated financial
statements have been audited by Ernst & Young LLP. During the course of
their audit, Ernst & Young LLP reviewed the Company's system of internal
control to the extent necessary to render their opinion on the consolidated
financial statements.
Bill Radvak
President & Chief Executive Officer
Rob Pilz
Chief Financial Officer
AUDITORS’ REPORT
To the Shareholders of
Response Biomedical Corp.
We have audited the consolidated
balance sheets of Response Biomedical Corp. as at December 31, 2004 and 2003
and the consolidated statements of loss and deficit and cash flows for each
of the years in the three-year period ended December 31, 2004. These financial
statements are the responsibility of the Company's management. Our responsibility
is to express an opinion on these financial statements based on our audits.
We conducted our audits in
accordance with Canadian generally accepted auditing standards and 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 consideration of internal control over financial reporting as a basis
for designing audit procedures that are appropriate in the circumstances, but
not for the purpose of expressing an opinion on the effectiveness of the Company's
internal control over financial reporting. Accordingly, we express no such opinion.
An audit also includes examining, on a test basis, evidence supporting the amounts
and disclosures in the financial statements, assessing the accounting principles
used and significant estimates made by management, and evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable
basis for our opinion.
In our opinion, these financial
statements present fairly, in all material respects, the consolidated financial
position of the Company as at December 31, 2004 and 2003 and the results of
its operations and cash flows for each of the years in the three year period
ended December 31, 2004 in accordance with Canadian generally accepted accounting
principles.
As discussed in Note 3 to the
consolidated financial statements, the Company changed its policy for the method
of accounting for stock-based compensation during 2003.
Chartered Accountants
Vancouver, Canada,
March 4, 2005.
Comments by Auditors
for United States Readers
on Canada-United States Reporting Difference
United States reporting standards
for auditors require the addition of an explanatory paragraph when the financial
statements are affected by conditions and events that cast substantial doubt
on the Company's ability to continue as a going concern, such as those described
in note 1 to the consolidated financial statements. Although we conducted our
audits in accordance with Canadian generally accepted auditing standards and
the standards of the Public Company Accounting Oversight Board (United States),
our report to the shareholders dated March 4, 2005 is expressed in accordance
with Canadian reporting standards which do not permit a reference to such conditions
and events in the auditors' report when these are adequately disclosed in the
financial statements.
Chartered Accountants
Vancouver, Canada,
March 4, 2005.
Response Biomedical
Corp.
-12-
CONSOLIDATED
FINANCIAL STATEMENT
Response Biomedical Corp.
Incorporated under the laws of British Columbia
CONSOLIDATED
BALANCE SHEETS
[See Note 1 - Basis of Presentation]
As at December 31
(Expressed in Canadian dollars)
2004
2003
$
$
ASSETS
Current
Cash
2,716,902
856
Short-term investments [note
8]
2,500
2,500
Trade receivables [note 4]
244,785
151,558
Other receivables
38,277
11,582
Inventories [note 5]
1,024,111
574,280
Prepaid expenses and other
52,076
14,380
Total current assets
4,078,651
755,156
Capital assets [note 6]
394,253
288,162
Deferred loan costs [note 7]
71,880
138,016
Total assets
4,544,784
1,181,334
LIABILITIES AND SHAREHOLDERS'
(DEFICIENCY)
Current
Bank indebtedness [note 8]
-
1,401,786
Accounts payable and accrued
liabilities
859,502
709,872
Loans payable to shareholders
and directors [note 9]
-
180,279
Deferred revenue - current
portion
90,505
51,208
Deferred lease inducement - current portion
7,450
7,450
Total current liabilities
957,457
2,350,595
Deferred revenue
155,271
-
Deferred lease inducement
1,240
8,687
1,113,968
2,359,282
Commitments and contingencies
[notes 10[e] and 13]
Shareholders' equity
(deficiency)
Share capital [note 10[a]]
35,606,778
28,821,536
Contributed surplus [notes
8, 10[a] and 10[c]]
3,662,970
900,473
Deficit
(35,838,932
)
(30,899,957
)
Total shareholders' (deficiency)
3,430,816
(1,177,948
)
4,544,784
1,181,334
See accompanying notes
On behalf of the Board:
William J. Radvak
Brian G. Richards
Director
Director
-13-
Response Biomedical
Corp
Response
Biomedical Corp.
CONSOLIDATED
STATEMENTS OF LOSS AND DEFICIT
[See Note 1 - Basis of Presentation]
Years ended December 31
(Expressed in Canadian dollars)
2004
2003
2002
$
$
$
REVENUE
Contract service fees and revenues
from
collaborative
research arrangements [note 14]
549,685
455,958
37,250
Product sales [note 14]
2,127,196
827,795
151,958
Total revenue
2,676,881
1,283,753
189,208
Less: cost of sales - products and services
1,304,447
730,967
41,579
Gross profit
1,372,434
552,786
147,629
EXPENSES
General and administrative
[note 11]
1,443,707
1,210,118
1,168,855
Research and development
2,215,614
2,153,828
2,654,751
Marketing and business development
[note 13[c]]
1,657,318
852,486
454,028
Stock-based compensation [note 10[c]]
814,682
136,918
136,000
Total expenses
6,131,321
4,353,350
4,413,634
OTHER EXPENSE
Interest expense [notes 8 and
9]
35,263
78,304
2,092
Loan costs [notes 7 and 8]
138,016
329,039
443,981
Interest income
(2,948
)
(457
)
(6,066
)
Miscellaneous income
-
-
(24,985
)
Gain on settlement with creditors
-
-
(15,832
)
Foreign exchange (gain) loss
9,757
(15,848
)
8,461
Total other expense
180,088
391,038
407,651
Loss for the year
(4,938,975
)
(4,191,602
)
(4,673,656
)
Deficit, beginning of year
(30,899,957
)
(26,708,355
)
(22,034,699
)
Deficit, end of year
(35,838,932
)
(30,899,957
)
(26,708,355
)
Loss per common share
- basic and diluted
note 10[f]]
(0.08
)
($0.09
)
($0.11
)
Weighted average number
of common shares
[note 10[f]]
58,713,725
48,164,132
43,228,309
See accompanying notes
Response Biomedical
Corp.
-14-
Response
Biomedical Corp.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
[See Note 1 - Basis of Presentation]
Years ended December 31
(Expressed in Canadian dollars)
2004
2003
2002
$
$
$
OPERATING ACTIVITIES
Loss for the year
(4,938,975
)
(4,191,602
)
(4,673,656
)
Add (deduct) items not involving
cash:
Amortization
of capital assets
206,816
135,816
79,200
Gain
on settlement with creditors
-
-
(15,832
)
Stock-based
compensation
814,682
136,918
136,000
Amortization
of deferred loan costs
138,016
329,039
443,981
Deferred
lease inducement
(7,447
)
16,137
-
Changes in non-cash working
capital:
Trade
receivables
(93,227
)
(24,330
)
(127,228
)
Other
receivables
(26,695
)
15,324
(7,862
)
Inventories
(449,831
)
(246,283
)
(327,997
)
Prepaid
expenses and other
(37,696
)
84,531
(26,398
)
Accounts
payable and accrued liabilities
149,630
311,613
47,104
Deferred revenue
194,568
-
(37,250
)
Cash used in operating activities
(4,050,159
)
(3,432,837
)
(4,509,938
)
INVESTING ACTIVITIES
Deposit on capital asset purchase
-
-
(16,557
)
Purchase of capital assets
(312,907
)
(197,495
)
(130,059
)
Short-term investments
-
(2,500
)
-
Cash used in investing activities
(312,907
)
(199,995
)
(146,616
)
FINANCING ACTIVITIES
Proceeds from issuance of common
shares and warrants,
net
of share issue costs [note 10[a]]
8,661,177
3,253,964
3,040,509
Proceeds from (repayment of)
bank indebtedness
(1,401,786
)
198,370
1,203,416
Proceeds from (repayment of)
loans from shareholders
and directors
(180,279
)
180,279
325,320
Cash provided by financing activities
7,079,112
3,632,613
4,569,245
Increase (decrease)
in cash during the year
2,716,046
(219
)
(87,309
)
Cash, beginning of year
856
1,075
88,384
Cash, end of year
2,716,902
856
1,075
Supplemental disclosure
Interest paid
35,263
78,304
2,092
See accompanying notes
-15-
Response Biomedical
Corp
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2004 and 2003
(Expressed in Canadian dollars)
1. NATURE OF BUSINESS
AND BASIS OF PRESENTATION
Response Biomedical Corp. (the
"Company") was incorporated on August 20, 1980 under the predecessor to the
Business Corporations Act (British Columbia). The Company is engaged in the
research, development and commercialization of diagnostic technologies for the
medical point of care ("POC") and on-site environmental testing markets. POC
and on-site diagnostic tests (or assays) are simple, non-laboratory based tests
performed using portable hand-held devices, compact desktop analyzers, single-use
test cartridges and/or dipsticks. Since 1996, the Company has developed and
commercialized a proprietary diagnostic system called RAMP
®
(Rapid
Analyte Measurement Platform).
The RAMP System is a portable
fluorescence immunoassay-based diagnostic technology that combines the performance
of a clinical lab with the convenience of a dipstick test - establishing a new
paradigm in diagnostic testing. Immunoassays are extremely sensitive and specific
tests used to identify and measure small quantities of materials, such as proteins.
Any biological molecule and most inorganic materials can be targeted. Accordingly,
the RAMP technology is applicable to multiple distinct market segments and many
products within those segments. RAMP tests are now commercially available for
the early detection of heart attack, environmental detection of West Nile Virus,
and biodefense applications including the rapid on-site detection of anthrax,
smallpox, ricin and botulinum toxin.
These consolidated financial
statements have been prepared in accordance with Canadian generally accepted
accounting principles on a going concern basis, which presumes that the Company
will be able to realize its assets and discharge its liabilities in the normal
course of business for the foreseeable future.
At December 31, 2004, the Company
had incurred significant losses and had an accumulated deficit of $35,838,932.
The Company's ability to continue as a going concern is uncertain and dependent
upon its ability to achieve profitable operations, obtain additional capital
and dependent on the continued support of its shareholders. Management is planning
to raise additional capital to finance expected growth. The outcome of these
matters cannot be predicted at this time. If the Company is unable to obtain
adequate additional financing, management will be required to curtail the Company's
operations.
These consolidated financial
statements do not include any adjustments to the amounts and classifications
of assets and liabilities which might be necessary should the Company be unable
to continue in business.
2. SIGNIFICANT ACCOUNTING
POLICIES
These consolidated financial
statements have been prepared in accordance with Canadian generally accepted
accounting principles. A reconciliation of amounts presented in accordance with
United States generally accepted accounting principles is detailed in note 16.
A summary of the significant accounting policies are as follows:
Basis of consolidation
These consolidated financial statements include the accounts of Response Biomedical
Corp. and its wholly-owned subsidiaries, Response Biomedical Inc., an inactive
United States company with nominal assets and liabilities and Response Development
Inc., an inactive Canadian company with nominal assets and liabilities.
Use of estimates
The preparation of these consolidated financial statements in conformity with
Canadian generally accepted accounting principles requires management to make
estimates and assumptions that affect the amounts reported in the consolidated
financial statements and accompanying notes. Actual results could differ from
those estimates.
Short-term investments
Short-term investments, which consist of financial instruments purchased with
an original maturity of greater than three months and less than one year, are
recorded at the lower of cost and market.
Inventories
Raw materials inventory is carried at the lower of actual cost, determined on
a first-in first-out basis and replacement cost. Finished goods and work in
process inventories are carried at the lower of weighted average cost and net
realizable value. Cost of finished goods and work in process inventories includes
materials, direct labour and applicable overhead.
Capital assets
Capital assets are recorded at cost and amortized over their estimated useful
lives using the straight-line method as follows:
Office and
laboratory furniture and equipment
5 years
Office and laboratory computer
equipment
3 years
Computer
software
2 years
Manufacturing equipment
5 years
Manufacturing
molds
2 years
Leasehold improvements
Term of lease
Deferred loan costs
Deferred loan costs reflect the costs incurred in connection with bank indebtedness
financings and are amortized on a straight-line basis over the terms of the
respective bank indebtedness and are included in loan costs in the consolidated
statement of loss.
Deferred lease inducements
Deferred lease inducements represent a rent-free period and are being amortized
over the term of the lease and recorded as a reduction of rent expense.
Foreign currency translation
Monetary items denominated in foreign currencies, including those of the Company's
U.S. integrated subsidiary, are translated into Canadian dollars using exchange
rates in effect at the balance sheet date. Revenue and expense items are translated
at the average exchange rate for the year. Foreign exchange gains and losses
are included in the determination of loss for the year.
Revenue recognition
Product sales are recognized upon the shipment of products to distributors,
if a signed contract exists, the sales price is fixed and determinable, collection
of the resulting receivables is reasonably assured and any uncertainties with
regard to customer acceptance are insignificant. Sales are recorded net of discounts
and sales returns. A provision for the estimated warranty expense is established
by a charge against operations at the time the product is sold.
Contract service fees are recorded
as revenue as the services are performed pursuant to the terms of the contract
provided collectibility is reasonably assured. Upfront fees from collaborative
research arrangements, which are non-refundable and require the ongoing involvement
of the Company are deferred and amortized into income on a straight-line basis
over the term of ongoing development. Upfront fees from collaborative research
arrangements, which are refundable are deferred and recognized once the refundability
period has lapsed.
Government assistance
Government grants are recorded as a reduction of the related expenditure when
there is reasonable assurance that the Company has complied with all conditions
necessary to receive the grants and collectibility is reasonably assured.
Research and development
costs
Research costs are expensed in the year incurred. Development costs are expensed
in the year incurred unless the Company believes a development project meets
Canadian generally accepted accounting criteria for deferral and amortization.
Loss per common share
Basic loss per common share is calculated using the weighted average number
of common shares outstanding during the year, excluding contingently issuable
shares. Diluted loss per common share is equivalent to basic loss per common
share as the outstanding options and warrants are anti-dilutive.
Future income taxes
The Company accounts for income taxes using the liability method of tax allocation.
Future income taxes are recognized for the future income tax consequences attributable
to differences between the carrying values of assets and liabilities and their
respective income tax bases. Future income tax assets and liabilities are measured
using substantively enacted income tax rates expected to apply to taxable income
in the years in which temporary differences are expected to reverse. The effect
on future income tax assets and liabilities of a change in substantively enacted
rates is included in earnings in the period that includes the enactment date.
Future income tax assets, net of a valuation allowance, are recorded in the
consolidated financial statements if realization is considered more likely than
not.
Stock-based compensation
The Company grants stock options to executive officers, directors, employees
and consultants pursuant to a stock option plan described in note 10[b]. The
Company uses the fair value method of accounting for all stock-based awards
for non-employees and for all stock-based awards
Response Biomedical
Corp.
-16-
2. SIGNIFICANT ACCOUNTING
POLICIES
(cont'd)
granted, modified or settled since January 1,2003 for awards to employees. For
stock-based awards to employees granted, modified or settled from January 1,
2002 to December 31, 2002, the Company discloses the pro forma effects to the
loss for the period and loss per common share for the period as if the fair
value method had been used at the date of grant. The pro forma information is
presented in note 10[c].
3. CHANGE IN ACCOUNTING POLICY
The Company has elected to
prospectively adopt the recommendations of the Canadian Institute of Chartered
Accountants (the "CICA") Handbook section 3870, Stock-Based Compensation and
Other Stock-Based Payments, for awards granted under its stock option plan to
executive officers, directors and employees, effective January 1, 2003. The
Company had adopted the recommendations, as required, for awards granted under
its stock option plan to non-employees. This standard and the amendments require
that all stock-based awards be measured and recognized using a fair value based
method. The fair value of stock options is estimated at the date of grant using
the Black-Scholes Option pricing model and is amortized over the vesting terms
of the stock options. As a result of the adoption of fair value accounting for
stock option grants to executive officers, directors, and employees effective
January 1, 2003, the Company recorded stock-based compensation expense of $434,182
[2003 - $82,518] during the year ended December 31, 2004 [note 10[c]].
4. FINANCIAL INSTRUMENTS
For certain of the Company's
financial instruments, including cash, short-term investment, trade receivables,
other receivables, accounts payable and loans payable to shareholders and directors,
the carrying amounts approximate fair values due to their short-term nature.
The Company performs ongoing
credit checks on its customers and requires orders to be prepaid by certain
customers. As at December 31, 2004, five [2003 - four] customers represent 72%
[2003 - 60%] of the trade receivables balance.
Financial risk is the risk
to the Company's results of operations that arise from fluctuations in interest
rates and foreign exchange rates and the degree of volatility of these rates.
The Company is subject to foreign exchange risk as substantially all its revenues
are denominated in US dollars. The Company mitigates foreign exchange risk as
it maintains US dollar bank accounts which are used to pay for expenses in US
dollars. Interest rate risk arises due to the Company's loans having
5. INVENTORIES
2004
2003
$
$
Raw materials
293,642
201,467
Work in process
94,535
207,060
Finished goods
635,934
165,753
1,024,111
574,280
6. CAPITAL ASSETS
Accumulated
Net book
Cost
amortization
value
$
$
$
2004
Office furniture and equipment
26,588
26,588
-
Office fcomputer equipment
58,213
49,754
8,459
Laboratory furniture and equipment
430.459
377,349
53,110
Laboratory computer equipment
229,089
80,903
148,186
Computer software
46,098
10,954
35,144
Manufacturing equipment
127,557
34,961
92,596
Manufacturing molds
162,266
138,136
24,130
Leasehold improvements
64,713
32,085
32,628
1,144,983
750,730
394,253
2003
Office furniture and equipment
26,588
23,929
2,659
Office computer equipment
51,427
44,402
7,025
Laboratory furniture and equipment
397,751
341,812
55,939
Laboratory computer equipment
44,614
40,976
3,638
Computer software
11,497
6,159
5,338
Manufacturing equipment
85,876
15,459
70,417
Manufacturing molds
149,610
64,978
84,632
Leasehold improvements
64,713
6,199
58,514
832,076
543,914
288,162
7. DEFERRED LOAN COSTS
2004
2003
$
$
Deferred loan costs
71,880
1,003,188
Less: amortization
-
(865,172
)
71,880
138,016
On December 31, 2004, the Company
capitalized loan costs of $71,880 [2003 - $413,155] and recorded amortization
expense in the year ended December 31, 2004 relating to the previously capitalized
loan costs of $138,016 [2003 - $329,039; 2002 - $443,981] [see notes
8 and 9].
8. BANK INDEBTEDNESS
As at December 31, 2004 the
Company has a revolving credit facility of up to US$1,000,000 [2003 - US$1,515,000]
with a Canadian chartered bank of which $nil [2003 - $1,401,786] was
utilized as at December 31, 2004. Amounts outstanding under this credit facility
are payable on demand and bear interest at the bank's prime rate which at December
31, 2004 was 4.25% [2003 - 4.5%] . This credit facility is guaranteed by a shareholder
up to December 31, 2005. Amounts advanced under the facility, if any, are repayable
in full on or before December 15, 2005. In consideration for providing the guarantee
in December 2004, the Company issued to the guarantor a total of 449,250 non-transferable
share purchase warrants entitling the holder to acquire one common share for
each warrant at an exercise price of $0.80 per common share expiring on
December 31, 2005 [2003 - 1,678,144 non-transferable share purchase warrants
expiring June 30, 2004].
The estimated fair value of
the share purchase warrants, using the Black-Scholes pricing model, amounting
to $71,880 in 2004 [2003 - $413,155] has been credited to contributed
surplus and recorded as deferred loan costs and is being amortized over the
term of the credit facility.
The Company has an additional
credit facility in the amount of $2,500 collateralized by an assignment
of a short-term investment.
9. LOANS PAYABLE TO
SHAREHOLDERS AND DIRECTORS
In August 2001, the Company
entered into a loan facility with several shareholders and directors, which
was collateralized by the Company's assets, bore interest at 8% per annum and
repayable up to August 2002. In April 2002, the Company agreed with its lenders
to issue common shares to settle the outstanding loan balances, which totaled
$1,794,400 as at April 3, 2002, through the issuance of 1,993,777 common
shares at a price of $0.90 per share [note 10[a]].
In November 2001, the Company
arranged a loan facility with one of its shareholders in the amount of $796,300
[US$500,000]. All advances under the loan facility were collateralized by
the Company's assets, bore interest at 8% per annum and repayable up to November
2002. In July 2002, the Company entered into a revolving line of credit facility
with a Canadian chartered bank [note 8] and simultaneously repaid the shareholder
loan.
As consideration for the August
2001 and November 2001 loans mentioned above, the Company issued a bonus to
the lenders of 1,424,662 common shares over a period of time, of which 1,107,936
common shares with a fair value of $346,234 were issued in 2001 and 316,726
common shares with a fair value of $149,399 were issued in 2002. The fair
value of these bonus shares were recorded as deferred loan costs and amortized
over the term of the loan.
During the year ended December
31, 2003, the Company entered into several short-term loan agreements with shareholders
and directors, which at December 31, 2003 amounted to $180,279. The loans
were without collateral, bore interest at 9% per annum and were repayable on
demand with maturity dates to June 30, 2004. During the year ended December
31, 2004, the loans plus accrued interest were repaid in full.
-17-
Response Biomedical
Corp
10. SHARE CAPITAL
[a]
Authorized
- 100,000,000
common shares without par value.
Issued and outstanding
Number
Amount
#
$
Balance, December 31,
2001
36,704,284
20,583,264
Issued for cash:
Exercise of warrants
4,321,600
1,604,277
Exercise of stock options
308,000
119,518
Private placement, net of issue costs [i]
2,413,364
1,316,714
Bonus shares [note 9]
316,726
149,399
Issued for settlement of loans
payable to
shareholders
and directors [note 9]
1,993,777
1,794,400
Balance, December 31,
2002
46,057,751
25,567,572
Issued for cash:
Exercise of warrants
1,090,750
490,828
Exercise of stock options
592,224
186,321
Private
placement, net of issue costs [ii and iii]
5,777,796
2,576,815
Balance, December 31,
2003
53,518,521
28,821,536
Issued for cash:
Exercise of warrants
4,795,471
2,535,613
Exercise of stock options
1,359,813
640,637
Private placement, net of issue costs [iv and v]
7,661,667
3,637,470
Issued as a finders fee [v]
100,000
-
Issed as a agent work fee [v]
-
(28,478
)
Balance, December 31, 2004
67,435,472
35,606,778
[i]
In March 2002, the
Company closed a non-brokered private placement consisting of 2,413,364
units at a price of $0.55 per unit, for total gross proceeds of $1,327,350
before share issue costs of $10,636. Each unit comprised one common
share and one-half of one common share purchase warrant. Each whole common
share purchase warrant entitled the holder to purchase one common share
of the Company at a price of $0.62 to $0.63 per share through
April 1, 2003.
[ii]
In June 2003, the
Company closed a non-brokered private placement consisting of 1,700,000
units at a price of $0.50 per unit, for gross proceeds of $850,000,
before share issuance costs of $5,609. Each unit comprised one common
share and one half of one common share purchase warrant. Each whole common
share purchase warrant entitles the holder to purchase one common share
of the Company at a price of $0.50 per share through June 13, 2004.
[iii]
In December 2003,
the Company closed a non-brokered private placement consisting of 4,049,873
units at a price of $0.43 per unit for gross proceeds of $1,741,445,
before share issuance costs of $9,021. Each unit comprised one common
share and one half of one common share purchase warrant. Each whole common
share purchase warrant entitles the holder to purchase one common share
of the Company at a price of $0.55 per share through December 29,
2004. In addition, the Company paid a finders fee through the issuance
of 27,923 common shares at a price of $0.48 per share, which has been
recorded as a share issue cost.
[iv]
In June 2004, the
Company clossed a non-brokered private placement consisting of 3,750,000
units at a price of $0.80 per unit for gross proceeds of $3,000,000
before a finders fee of $200,000 and legal cost of $5,374 for
net proceeds of $2,794,626. Each unit comprised one common share and
one half of one common share purchase warrant. Each whole common share
purchase warrant entitles the holder to purchase one common share of the
Company at a price of $1.15 per share expiring June 21, 2006.
The 1,875,000 share
purchase warrants issued as a result of the private placement have been
classified as a separate component of equity, the fair value of which
has been determined using the Black-Scholes pricing model using the following
assumptions: dividend yield 0.0%; expected volatility 72.70%; risk-free
interest rate 3.00%; and expected life of 1.41 years. Accordingly, $663,723
of the proceeds, net of share issuance cost of $48,777, has been allocated
as the fair value of the warrants, which is recorded in contributed surplus
in the consolidated balance sheet.
[v]
In December 2004
the Company closed a private placement consisting of 3,911,667 units at
a price of $0.75 per unit for gross proceeds of $2,933,750, before
share issuance costs of $318,449 for net proceeds of $2,615,301.
The private placement comprises of a brokered amount of $2,227,500
in addition to a non-brokered amount of $706,250.
Each unit comprised
one common share and two one-half of one non-transferable common share
purchase warrants with a four-month hold period expiring on May 1, 2005.
The first half-warrant entitles the holder to purchase one common share
of the Company for each whole warrant at a price of $1.00 per share,
expiring on December 30, 2005. The second half-warrant entitles the holder
to purchase one common share of the Company for each whole warrant at
a price of $1.25 per share up to December 30, 2005 and at a price
of $1.50 per share from December 31, 2005 expiring on December 30,
2006.
In connection with the
financing, the Company paid a cash commission of $178,200, legal and
professional fees of $65,249 and granted 100,000 units to the agent
of this financing. The 100,000 units were valued at the market price of
$75,000 and were recorded as share issuance cost. In addition, the
Company granted a non-transferable option entitling the agent to purchase
391,167 units, exercisable at a price of $0.75 per unit. The option
expires on December 30, 2006. The fair value of these units option of
$50,852, was estimated using the Black-Scholes option pricing model
with the following assumptions: dividend yield 0.0%; expected volatility
59%; risk-free interest rate 3.00%; and expected life of 6 months. $28,478
and $22,374 of the total fair value of the unit option has been recorded
against share capital and the fair value of the warrants, respectively,
as share issuance cost with a corresponding credit to contributed surplus.
The 4,011,667 share purchase
warrants issued as a result of the private placement have been classified
as a separate equity component from share capital the fair value of which
has been determined using the Black-Scholes pricing model using the following
weighted average assumptions: dividend yield 0.0%; expected volatility
71.35%; risk-free interest rate 3.00%; and expected life of 1.41 years.
Accordingly, $1,183,734 of the proceeds, net of share issuance cost
of $140,117, has been allocated as the fair value of the warrants,
which is included in contributed surplus in the consolidated balance sheet.
[b] Stock option plan
On June 19, 1996, and subsequently
amended on various dates through June 21, 2004, the shareholders approved a
stock option plan (the "Plan") to reward executive officers, directors, employees
and consultants who contribute to the continued success of the Company. The
exercise price of the options is determined by the Board but generally will
be equal to the greater of the average closing price of the common shares for
the ten trading days immediately preceding the date of grant or the closing
price on the date of grant (Fair Market Value). The options generally vest over
a period of 18 months and the term may not exceed ten years. In accordance with
the Plan, the Company may grant options to purchase up to a maximum of 11,500,000
[December 31, 2003 - 10,000,000] common shares of the Company at any one point
in time. The effective date of the Plan was April 19, 1996 and the Plan will
terminate April 19, 2006. The vesting periods and terms of the stock options
granted prior to the expiration of the Plan will remain effective following
the expiration of the Plan. Any unexercised stock options are available for
the purposes of the Plan. At December 31, 2004, the Company has 3,858,500 [December
31, 2003 - 3,889,650] stock options available for further issuance.
At December 31, 2004 the following
stock options were outstanding:
Options outstanding
Options exercisable
December 31, 2004
December 31, 2004
Range of
Number of
Weighted average
Weighted
Number of
Weighted
exercise
shares
remaining
average
options currently
average
prices
under option
contractual life
exercise
price exercisable
exercise price
$
#
(years)
$
#
$
0.27 - 0.36
1,145,250
1.83
0.27
1,145,250
0.27
0.40 - 0.49
45,200
3.35
0.46
37,075
0.46
0.50 - 0.57
2,780,100
2.21
0.50
2,441,350
0.50
0.61 - 0.68
339,100
1.69
0.63
339,100
0.63
0.72 - 0.79
1,337,050
3.25
0.73
680,876
0.73
0.80 - 0.87
1,758,450
3.62
0.82
828,725
0.83
0.90 - 1.27
211,350
3.51
1.01
129,976
1.01
1.78
25,000
0.22
1.78
25,000
1.78
7,641,500
2.67
0.60
5,627,352
0.55
The options expire at various
dates from March 25, 2005 to December 6, 2009.
Response Biomedical
Corp.
-18-
10. SHARE CAPITAL [b] STOCK OPTION
PLAN
(cont'd)
Stock option transactions and the number of
stock options outstanding are summarized as follows:
Weighted
Number
of
average
optioned
exercise
common
shares
price
#
$
Balance, December 31,
2001
5,054,100
0.53
Options granted
2,125,400
0.61
Options forfeited
(161,700
)
0.65
Options expired
(537,500
)
1.22
Options exercised
(308,000
)
0.39
Balance, December 31,
2002
6,172,300
0.49
Options granted
1,086,300
0.57
Options forfeited
(105,026
)
0.60
Options cancelled
(155,000
)
0.55
Options expired
(296,000
)
1.06
Options exercised
(592,224
)
0.32
Balance, December 31,
2003
6,110,350
0.49
Options granted
3,282,700
0.75
Options forfeited
(121,737
)
0.73
Options expired
(270,000
)
0.42
Options exercised
(1,359,813
)
0.47
Balance, December 31, 2004
7,641,500
0.60
The exercise price equaled
the Fair Market Value on the date of grant for all options issued during the
year ended December 31, 2004 and 2003.
[c] Stock-based compensation
For the year ended December
31, 2004, the estimated fair value of stock options granted to employees resulted
in compensation expense of $434,182 [2003 - $82,518] and the estimated
fair value of stock options granted to non-employees resulted in compensation
expense of $380,500 [2003 - $54,400; 2002 - $136,000], with a corresponding
credit to contributed surplus.
The fair value of stock options
granted during the year ended December 31, 2004 was estimated using the Black-Scholes
option pricing model with the following weighted average assumptions and resulting
fair value:
2004
2003
2002
$
$
$
Dividend yield
0.0%
0.0%
0.0%
Expected volatility
128%
99%
132%
Risk-free interest rate
3.36%
3.14%
3.36%
Expected life
2.45 years
1.65 years
1.98 years
Fair value per share
0.42
0.21
0.39
The following table provides
pro forma loss for the year and pro forma basic and diluted loss per share had
compensation expense, for awards granted to employees from January 1, 2002 to
December 31, 2002, been based on the fair value method of accounting for stock-based
compensation:
2004
2003
2002
$
$
$
Loss for the year, as reported
(4,938,975
)
(4,191,602
)
(4,673,656
)
Pro forma compensation expense
-
(393,392
)
(277,000
)
Pro forma loss for the year
(4,938,975
)
(4,584,994
)
(4,950,656
)
Pro forma loss per share - basic and diluted
(0.08
)
(0.10
)
(0.11
)
The following table shows stock-based
compensation allocated by type of cost:
2004
2003
2002
$
$
$
Cost of sales - products and
services
84,102
11,597
977
General and administrative
449,620
106,672
91,950
Research and development
179,360
15,633
34,573
Marketing and business development
101,600
3,016
8,500
814,682
136,918
136,000
[d] Escrow shares
Pursuant to an escrow agreement
dated December 31, 1995 and approved by the shareholders on June 19, 1996, 825,000
common shares are held in escrow as at December 31, 2004. At the shareholders
meeting on June 21, 2004, the shareholders approved a resolution to amend the
terms of the escrow agreement, such that
the escrow release is now based on a six-year time release formula, in accordance
with the policies of the TSX Venture Exchange. Previously, the escrow shares
were to be released based on the Company's cumulative cash flow. Commencing
in March 2005, 825,000 common shares currently held in escrow will be released
in 12 tranches over a period of six years, with tranches released every six
months. Each of the first four tranches consists of 41,250 common shares or
5% of the total escrow shares and each of the remaining eight tranches consists
of 82,500 common shares or 10% of the total escrow shares.
[e] Common share purchase warrants
At December 31, 2004, the following common
share purchase warrants were outstanding:
Number of
common shares
Exercise price
issuable
$
Date of expiry
1,875,000
[note 10[a][iv]]
1.15
June 18, 2006
449,250
[note 8]
0.80
December 31, 2005
2,005,835
[note 10[a][v]]
1.00
December 30, 2005
2,005,832
[note
10[a][v]]
1.25 - 1.50*
December 30, 2006
6,335,917
1.19
*The exercise price is $1.25
if exercised prior to December 31, 2005, and $1.50 thereafter.
The Company is required to
pay additional finders fees of $117,813 upon exercise of the 1,875,000 share
purchase warrants issued pursuant to the June 2004 financing.
Common share purchase warrant
transactions are summarized as follows:
Number
of
Weighted
common
shares
average
exercise
issuable
price $
Balance, December 31,
2001
9,713,850
0.76
Warrants issued
1,617,108
0.65
Warrants expired
(4,305,500
)
1.23
Warrants exercised
(4,321,600
)
0.37
Balance, December 31,
2002
2,703,858
0.59
Warrants issued
4,553,081
0.51
Warrants expired
(1,369,467
)
0.61
Warrants exercised
(1,090,750
)
0.45
Balance, December 31,
2003
4,796,722
0.53
Warrants issued
6,335,917
1.19
Warrants expired
(1,251
)
0.55
Warrants exercised
(4,795,471
)
0.53
Balance, December 31, 2004
6,335,917
1.19
[f] Loss per common share
2004
2003
2002
Numerator
Loss for the year
(4,938,975
)
(4,191,602
)
(4,673,656
)
Denominator
Weighted average number of
common shares
outstanding
58,713,725
48,989,132
44,053,309
Less: escrowed shares [note 10[d]]
-
825,000
825,000
Weighted average number of
common shares
outstanding
58,713,725
48,164,132
43,228,309
Loss per common share - basic and
diluted
(0.08
)
(0.09
)
(0.11
)
[g] Other
As at December 31, 2004, options
to acquire 391,167 units, comprising one common share and two one-half non-transferable
common share purchase warrants, are outstanding [see note 10[a][v]].
11. RELATED PARTY TRANSACTIONS
In addition to the transactions
described in notes 8 and 9, the following payments were made to directors or
companies related to or under their control:
2004
2003
2002
$
$
$
General and administrative
Strategic consulting services
[i]
71,930
-
7,300
Share issue costs
20,522
-
-
-19-
Response Biomedical
Corp
11. RELATED PARTY TRANSACTIONS
(cont'd)
All related party transactions
are recorded at their exchange amounts, established and agreed between the parties.
[i] The Company has entered
into a strategic consulting services agreement with a company controlled by
a director. Pursuant to the terms of the agreement, the Company is required
to pay a monthly fee of US$5,000, expiring June 30, 2005.
12. INCOME TAXES
At December 31, 2004 the Company
had approximately $16,203,000 of non-capital loss carryforwards and approximately
$2,384,000 of federal investment tax credits available to reduce taxable
income and taxes payable for future years. These losses and investment tax credits
expire as follows:
Federal
investment
Non-capital
loss
tax credits
carryforwards
$
$
2005
-
1,016,000
2006
149,000
2,058,000
2007
111,000
3,164,000
2008
153,000
2,157,000
2009
227,000
3,028,000
2010
430,000
2,080,000
2011
384,000
2,700,000
2012
233,000
-
2013
380,000
-
2014
317,000
-
2,384,000
16,203,000
In addition, the Company has
approximately $968,000 of provincial investment tax credits that expire
between the years 2010 and 2014.
Significant components of the
Company's future tax assets as of December 31 are shown below.
2004
2003
$
$
Future tax assets:
Book amortization
in excess of tax capital cost allowance
628,000
484,000
Net operating loss carryforwards
5,773,000
4,910,000
Research and development
deductions and credits
5,689,000
5,158,000
Share issue costs
133,000
60,000
Unearned revenue
88,000
18,000
Total future tax assets
12,311,000
10,630,000
Valuation allowance
(12,311,000
)
(10,630,000
)
Net future tax assets
-
-
The potential income tax benefits
relating to these future tax assets have not been recognized in the consolidated
financial statements as their realization did not meet the requirements of "more
likely than not" criterion. Accordingly, a valuation allowance has been recorded
and no future tax assets have been recognized as at December 31, 2004 and 2003.
The reconciliation of income
tax attributable to operations computed at the statutory tax rate to income
tax expense (recovery), using a 35.62% [2003 - 37.62%; 2002 - 39.62%] statutory
tax rate, at December 31 is:
2004
2003
2002
$
$
$
Income taxes at statutory rates
(1,759,000
)
(1,577,000
)
(1,856,000
)
Expenses not deductible for
tax
206,000
175,000
230,000
Expenses capitalized for tax
purposes
594,000
681,000
762,000
Losses not recognized for tax
purposes
962,000
784,000
927,000
Other
(3,000
)
(63,000
)
(63,000
)
-
-
-
13. COMMITMENTS AND CONTINGENCIES
[a] Research and license agreements
The Company entered into an
exclusive license agreement with the University of British Columbia ("UBC")
effective March 1996, as amended October 2003, to use and sublicense certain
technology ("Technology") and any improvements thereon, and to manufacture,
distribute and sell products in connection therewith. In consideration for these
rights, the Company paid a non-refundable license fee of $5,000 upon execution
of the agreement and $5,000 in January 1997, and is required to pay quarterly
royalties based on 2% of revenue generated from the sale of products
that incorporate the Technology. In addition, in the event the Company sublicenses
the Technology, the Company shall pay to UBC a royalty comprised of 20% of the
first $1,000,000 of sublicensing revenue per calendar year and 10% of sublicensing
revenue that exceeds $1,000,000 in each calendar year. Commencing in 2003
and for a period of nine years thereafter, royalties payable to UBC are subject
to a $2,500 quarterly minimum plus a $500 annual license maintenance
fee. These payments are expensed in the year incurred. The agreement terminates
on the expiration date or invalidity of the patents or upon bankruptcy or insolvency
of the Company.
[b] Supply agreement
The Company entered into a
Supply Agreement (the "Agreement") with a supplier, effective September 2003
for certain reagents for the Company's West Nile Virus Test. In addition to
paying for the reagent purchased, the Company is required to pay the supplier
semi-annual royalties based on 10% of net revenue generated from the sale of
the Company's RAMP West Nile Virus Test, with the first payment due six months
after the first commercial sale of the product. The term of the agreement is
three years from the effective date and is automatically renewed for each successive
period of one year until either party terminates the Agreement. In 2004, the
Company paid $50,101 [2003 - $nil] of royalties to the supplier.
[c] Marketing program
During the year ended December
31, 2004, the Company received a contribution of $49,700 [2003 - $nil]
under Industry Canada's Program for Export Market Development (the "Program")
for reimbursement of certain expenses related to sales and marketing efforts
in the United States. Pursuant to the Program, the Company is required to repay
to Industry Canada an amount representing 4% of incremental sales as defined
in the Program up to April 2007. As at December 31, 2004 the criteria for repayment
has not been met. The amount of $49,700 has been treated as a reduction
of marketing and business development expenses in the statements of loss and
deficit.
[d] Lease agreements
The Company leases its office
and research facilities pursuant to an accepted offer to sublease for which
current minimum monthly payments are approximately $18,000 per month.
Rent expense for the year ended
December 31, 2004 was $208,552 [2003 - $229,170; 2002 - $247,000].
[e] Finder's fees of $117,813
are payable upon exercise of the share purchase warrants issued pursuant to
the June 2004 private placement [note 10[e]].
[f] Contingency
The Company is defending a
claim by a former employee for damages related to alleged inducement from a
previous employer and misrepresentation. The Company has denied all allegations
in the former employee's Statement of Claim, however, has made an accrual for
the potential costs relating to the claim. The Company does not expect the loss,
if any, to have a material effect on the Company's operating results.
14. SEGMENTED INFORMATION
The Company operates primarily
in one business segment in the research, development and commercialization of
diagnostic technologies with substantially all of its assets and operations
located in Canada. Company's revenues are generated from product sales in Canada,
US, Europe, Asia and the Middle East. Expenses are primarily incurred in Canada
and the US.
For the year ended December
31, 2004, of the Company's total contract service fees and revenues from collaborative
research arrangements of $549,685, $434,251 were generated from three
customers [2003 - five customers for a total of $455,958; 2002 - one customer
for a total of $37,250].
Contract service fees and revenues
from collaborative research arrangements by customer location were as follows:
2004
2003
2002
$
$
$
Canada
255,250
40,484
-
United States
243,227
415,474
-
Asia
51,208
-
37,250
Total
549,685
455,958
37,250
Response Biomedical
Corp.
-20-
14. SEGMENTED INFORMATION
(cont'd)
Product sales by customer location were as follows:
2004
2003
2002
$
$
$
Canada
112,021
96,087
106,407
United States
1,422,476
455,414
7,404
Europe
42,128
88,040
26,818
Asia
517,755
137,738
-
Middle East
21,649
32,646
-
Other
11,167
17,870
11,329
Total
2,127,196
827,795
151,958
Product sales by type of product are as follows:
2004
2003
2002
$
$
$
Biodefense products
879,637
567,872
113,811
Clinical products
506,475
170,781
38,147
Vector products (West Nile Virus)
741,084
89,142
-
Total
2,127,196
827,795
151,958
15. COMPARATIVE FIGURES
Certain comparative figures
have been reclassified from the amounts previously reported to conform to the
presentation adopted in the current year.
16. RECONCILIATION
OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
The Company prepares the consolidated
financial statements in accordance with Canadian generally accepted accounting
principles ("Canadian GAAP") which, as applied in these consolidated financial
statements, conform in all material respects to United States generally accepted
accounting principles ("U.S. GAAP"), except as follows:
[a] For U.S. GAAP purposes,
the Company has elected to prospectively adopt Statement of Financial Accounting
Standard No. 148 (SFAS 148), "Accounting for Stock-Based Compensation-Transition
and Disclosure", an amendment to Statement of Financial Accounting Standard
No. 123 (SFAS 123) "Accounting for Stock-Based Compensation" for employee awards
granted under its stock option plan, modified or settled subsequent to January
1, 2003. The standard permits the prospective recognition of stock-based compensation
expense for all employee stock-based compensation transactions occurring subsequent
to January 1, 2003 using a fair value based method. Prior to the adoption of
this standard, the Company applied the disclosure provisions of SFAS 123 for
stock options granted to employees. As allowed by SFAS 123, the Company followed
the intrinsic value approach of Accounting Principles Board Opinion No. 25 "Accounting
for Stock Issued to Employees" (APB 25) which resulted in no compensation expense
being recognized for the year ended December 31, 2002 as the exercise price
of the Company's employee stock options equaled the market price of the underlying
stock on the date of grant. As the Company has prospectively adopted comparable
accounting standards for both U.S. GAAP and Canadian GAAP during the year ended
December 31, 2003 with respect to employee stock-based awards, no difference
arises for the periods presented.
[b] Under U.S. GAAP, the excess,
if any, of the fair value of the shares in escrow over the nominal value paid
will be recorded as compensation expense upon release from escrow.
[c] For purposes of reconciliation
to U.S. GAAP, the re-pricing of options is subject to variable plan accounting
under APB 25, which can give rise to additional compensation expense. Under
SFAS 123 such repricing are not subject to variable plan accounting and therefore
upon adoption of SFAS 123, the Company no longer records additional compensation
expense. In fiscal 2004, compensation income of $nil [2003 - $nil; 2002
- ($326,512)] resulted from the re-pricing of options.
If U.S. GAAP were followed:
[i] the effect on the Statements
of Loss and Deficit would be:
2004
2003
2002
$
$
$
Loss for the year, Canadian
GAAP
(4,938,975
)
(4,191,602
)
(4,673,656
)
Adjustment with respect to
prepricing of
certain stock options [c]
-
-
(326,512
)
Loss and comprehensive loss
of the year
U.S. GAAP
(4,938,975
)
(4,191,602
)
(5,000,168
)
Basic and diluted loss per common share,
U.S. GAAP
(0.08
)
(0.09
)
(0.12
)
Weighted average number of common,
shares, U.S. GAAP (in thousands)
58,713,725
48,164,132
43,228,309
[ii] The effect on Balance Sheet items would
be:
2004
2003
$
$
Contributed surplus
2,110,317
1,172,903
Deficit
(36,111,362
)
(31,172,387
)
[d] Accounts payable
and accrued liabilities comprise:
2004
2003
$
$
Trade accounts payable
472,828
515,544
Employee-related accruals
258,165
74,285
Other accrued liabilities
128,509
120,043
859,502
709,872
[e] Pro forma information - Stock-based
compensation
The following pro forma financial
information presents the loss for the period and basic and diluted loss per
common share had the Company recognized stock-based compensation for stock options
granted to employees and directors using a fair value based method for all stock-based
transactions prior to January 1, 2003. For stock options granted in 2002, the
fair value for these options was estimated at the date of grant using a Black-Scholes
pricing model with the following weighted-average assumptions: dividend yield
- 0%; expected volatility - 97.62%; risk-free interest rate - 4.24%; and expected
average life of the options - 2.5 years. For stock options granted in 2004 and
2003, see note 10.
Applying the above, supplemental
disclosure of pro forma loss and loss per share is as follows:
2004
2003
2002
$
$
$
Loss for the year, U.S. GAAP
(4,938,975
)
(4,191,602
)
(5,000,168
)
Add: Stock-based employee compensation
expense
included in reported loss above
434,182
82,518
-
Deduct: Total stock-based emloyee
compensation
expense
using fair value based method for
all
awards
(434,182
)
(131,457
)
(359,439
)
Pro forma loss for the period
(4,938,975
)
(4,240,541
)
(5,359,607
)
Basic and diluted loss per
common share
As
reported
($0.08
)
($0.09
)
($0.11
)
Pro
forma
($0.08
)
($0.09
)
($0.12
)
[f] Recent accounting pronouncements
In December 2004, the Financial
Accounting Standards Board issued SFAS 123(R) "Share-Based Payment", a revision
to SFAS 123 "Accounting for Stock-Based Compensation". SFAS 123(R) requires
all share-based payments to be recognized in the financial statements based
on their fair values using either a modified-prospective or modified-retrospective
transition method as defined in the standard. The standard no longer permits
pro forma disclosure or the prospective recognition adopted by the Company in
fiscal 2003. Accordingly, from the date of adoption of the revised standard,
the Company will be required to recognize compensation expense for all share-based
payments based on grant-date fair value, including those granted, modified or
settled prior to January 1, 2002. The Company will be required to adopt the
revised standard no later than January 1, 2006. Early adoption is permitted
in periods in which financial statements have not been issued.
The impact of adoption of SFAS
123(R) cannot be predicted at this time because it will depend on levels of
share-based payments granted in the future. However, had the Company adopted
SFAS 123(R) in prior periods, the impact of that standard would have approximated
the impact of SFAS 123 as described in the disclosure of pro forma loss for
the period and loss per common share in note 16[e] to these consolidated financial
statements.
17. SUBSEQUENT EVENT
Subsequent to December 31,
2004, the Company issued 164,000 common shares pursuant to the exercise of stock
options for gross proceeds of $89,085.
-21-
Response Biomedical
Corp
BOARD OF
DIRECTORS
MANAGEMENT
Stephen D. Holmes,
LLB
William J. Radvak
Partner & Chairman
President & Chief Executive
Officer
Holmes, Greenslade
Robert G. Pilz, B.Comm., CMA,
William J. Radvak
Chief Financial Officer &
Vice President, Finance
President & Chiefhief
Executive Officer
Response Biomedical
Corp.
Brian G. Richards, PEng
Chief Operating Officer &
Corporate Secretary
Dominique Merz, Ph.D.
Principal
Michael Groves, Ph.D.
Diligens Officium
LLC
Vice President, Sales &
Marketing
Stan Yakatan, MBA
Reed W. Simmons, MBA
Chairman, President
& Chief Executive Officer
Vice President, Manufacturing
Katan Associates
International
Paul C. Harris, Ph.D.
Brian G. Richards,
PEng
Vice President, Research &
Development
Chief Operating Officer
& Corporate Secretary
Response Biomedical
Corp.
Joanne Stephenson, MBA
Vice President, Business Development
Sidney Braginsky
Director
Noven Pharmaceuticals
Scientific Advisory
Board
Transfer
Agent & Registrar
Robert Christenson, Ph.D.,
DABCC,
FACBFAC
Computershare Investor
Services
University of Maryland MedicalMedi
Center
510 Burrard Street
Vancouver, BC V6C
3B9
Stephen Kahn, Ph.D., DABCC,
FACB
Tel: (604) 661-9400
Loyola University Medical Center
Communication concerning
transfer requirements,
E. Magnus Ohman, MD, FRCPI,
FACC
lost certificates,
changes of address and other similar
University of North Carolina
inquiries should
be addressed to the Transfer Agent
and Registrar.
Stock Listing
Independent
Auditors
Common shares of Response Biomedical
Corp. are traded
under the symbol "RBM" on the
TSX Venture Exchange.
Ernst & Young
LLP
Pacific Centre
Annual General Meeting
PO Box 10101
700 West Georgia
Street
The Annual General Meeting
of Shareholders will be held at
Vancouver, BC V7Y
1C7
2:00 pm, Tuesday, June 21,
2005 in the Stanley Room at
Tel: (604) 891-8200
the Hyatt Regency Vancouver,
655 Burrard Street, Vancouver, BC.
Legal Counsel
Response Biomedical Corp.
8081 Lougheed Highway
Axium Law Group
Burnaby, BC
Four Bentall Centre
Canada V5A 1W9
Suite 3350, 1055
Dunsmuir Street
Tel: (604) 681-4101
Vancouver, BC V7X
1L2
Fax: (604) 412-9830
Tel: (604) 685-6100
Email: info@responsebio.com
Website: www.responsebio.com
Receive Shareholder
Updates Via E-Mail
We encourage you to register to receive shareholder materials via e-mail. This
approach provides the most immediate distribution of information. For more information
and to sign-up for electronic delivery, please visit our website at www.responsebio.com.
www.responsebio.com
email info@responsebio.com
Tel. 604.681.4101 Fax 604.412.9830 Toll Free in North
America 1.888.591.5577
Response Biomedical Corp. 8081 Lougheed Highway, Burnaby, B.C. Canada V5A 1W9