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As filed with the Securities and Exchange Commission on December 15, 1998
Commission File No. ________
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM F-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
VISIBLE GENETICS INC.
(Exact name of Registrant as specified in its charter and
translation of Registrant's name into English)
Ontario n/a
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
700 Bay Street
Suite 1000
Toronto, Ontario
Canada M5G 1Z6
(416) 813-3242
(Address and telephone number of Registrant's principal executive offices)
Baer Marks & Upham LLP
805 Third Avenue
New York, New York 10022
Attention: Steven S. Pretsfelder, Esq.
(212) 702-5730
(Name, address and telephone number of agent for service)
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Copies to:
Steven S. Pretsfelder, Esq. Samuel Schwartz, Esq.
Baer Marks & Upham LLP Goldman, Spring, Schwartz & Kichler
805 Third Avenue 40 Sheppard Avenue West
New York, New York 10022 Suite 700
North York, Ontario
Canada M2N 6K9
Approximate date of commencement of proposed sale to the public: As soon as
practicable after this Registration Statement becomes effective.
If the only securities being registered on this Form are being offered
pursuant to dividend or interest reinvestment plans, please check the following
box. / /
If any of the securities being registered on this Form are to be
offered on a delayed or continuous basis pursuant to Rule 415 under the
Securities Act of 1933, check the following box. /X/
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. [ ] ____.
If this Form is a post-effective amendment filed pursuant to Rule
462(c) under the Securities Act, check the following box and list the Securities
Act registration statement number of the earlier effective registration
statement for the same offering. [ ] ___.
If delivery of the prospectus is expected to be made pursuant to Rule
434, please check the following box. [ ]
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Calculation of Registration Fee
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Title of each class Amount to be Price per Share(1) Proposed Amount of
of securities to be registered maximum registration fee
registered aggregate offering
price
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<S> <C> <C> <C> <C>
Common Shares 76,734 $10.563 $810,541.24 $225.33
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(1)This amount is based upon the average of the closing bid and asked prices as
of December 14, 1998, and is being used solely for the purpose of calculating
the registration fee pursuant to Rule 457 under the Securities Act of 1933.
The Registrant hereby amends this Registration Statement on such date
or dates as may be necessary to delay its effective date until the Registrant
shall file a further amendment which specifically states that this Registration
Statement shall thereafter become effective in accordance with Section 8(a) of
the Securities Act of 1933 or until this Registration Statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
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SELLING SHAREHOLDERS'
PROSPECTUS
VISIBLE GENETICS INC.
76,734 Common Shares
Nasdaq National Market
VGIN
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This Investment involves a High - This is an offering of Common Shares by
Degree of Risk. You should Purchase certain warrantholders of Visible Genetics
Shares Only If You Can Afford a Inc. The Shares covered by this Prospectus
Complete Loss of Your Investment. will be issued to the warrantholders, and may
See Risk Factors beginning on page 4. be sold by them, upon exercise of their
warrants.
------------
- The selling shareholders will receive all of
Neither the Securities and the proceeds from the sale of the Shares, less
Exchange Commission nor any state any commissions or discounts paid to brokers
securities commission has approved or or other agents. We will not receive any of
disapproved the Shares, or determined the proceeds from the sale of the Shares.
if this Prospectus is truthful or
complete. Any representation to the - The selling shareholders may offer and sell
contrary is a criminal offense. the Shares on the Nasdaq National Market at
prevailing market prices, or in privately
negotiated transactions at prices other
than the market price. On December 14,
1998, the closing sale price for our
Common Shares on the Nasdaq National Market
was $10.50.
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The information in this Prospectus is not complete and may be changed.
The selling shareholders may not sell their Shares until the registration
statement filed with the Securities and Exchange Commission is effective. This
Prospectus is not an offer to sell Shares and it is not soliciting an offer to
buy Shares in any state where the offer or sale is not permitted.
December __, 1998
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TABLE OF CONTENTS
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Page
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE...................................................................1
PROSPECTUS SUMMARY................................................................................................2
FORWARD-LOOKING STATEMENTS........................................................................................3
RISK FACTORS......................................................................................................4
INFORMATION ABOUT THE COMPANY....................................................................................15
CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS......................................................................20
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL................................................................26
SELLING SHAREHOLDERS.............................................................................................31
PLAN OF DISTRIBUTION.............................................................................................32
DESCRIPTION OF CAPITAL SHARES....................................................................................34
LEGAL MATTERS....................................................................................................35
EXPERTS..........................................................................................................35
ADDITIONAL INFORMATION...........................................................................................35
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INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents which we filed with the Securities and Exchange
Commission are incorporated by reference in this Prospectus:
(1) our Annual Report on Form 20-F for the year ended December 31,
1997, which we refer to in the rest of this document as our Annual Report; and
(2) our Report on Form 6-K dated June 18, 1998.
In addition, all documents which we file with the Securities and
Exchange Commission ("Commission") pursuant to Section 13, 14 or 15(d) of the
Securities Exchange Act of 1934, as amended (the "Exchange Act") after the date
of the Registration Statement and before termination of the offering of Shares,
including all annual reports on Form 20-F or Form 10-K, and all filings on Forms
10-Q and 8-K, will be deemed to be incorporated by reference in this Prospectus
and to be a part of this Prospectus from the date those documents are filed. We
may also incorporate in this Prospectus any Form 6-K which we file with the
Securities and Exchange Commission by identifying in such Form that it is being
incorporated by reference into this Prospectus. Any statement contained in a
document which is incorporated, or deemed to be incorporated, by reference into
this Prospectus, shall be considered modified or superseded for purposes of this
Prospectus to the extent that a statement contained in this Prospectus or in any
other subsequently filed document which also is, or is deemed to be,
incorporated by reference herein modifies or supersedes such statement. Any such
statement so modified or superseded shall not be deemed, except as so modified
or superseded, to constitute a part of this Prospectus.
You may request a copy of any document incorporated by reference in
this Prospectus at no cost. To receive a copy, write or call us at Visible
Genetics Inc., 700 Bay Street, Suite 1000, Toronto, Ontario, Canada M5G 1Z6,
Attention: Mr. Jeffrey Sherman, (416) 813-3266.
We are subject to the informational requirements of the Exchange Act
and file reports and other information with the Commission. Reports and other
information which we file with the Commission, including the Registration
Statement on Form F-3 of which this Prospectus is a part, may be inspected and
copied at the public reference facilities of the Commission at Judiciary Plaza,
450 Fifth Street, N.W., Room 1024, Washington, D.C. 20549. Copies of this
material may also be obtained by mail from the Public Reference Section of the
Commission, 450 Fifth Street, N.W., Washington, D.C. 20549, at prescribed rates.
The Commission's telephone number is 1-800-SEC-0330.
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PROSPECTUS SUMMARY
We develop, manufacture and sell commercial DNA sequencing systems that
use genetic information to improve disease management. Our DNA sequencing
system, which we call the OpenGene-TM- System, is capable of identifying changes
in the DNA of genes (genetic mutations) associated with specific diseases
faster, more accurately and at a lower cost than other commercially available
systems. We believe that the combination of these features in one system will
enable genetic sequencing to be used widely by doctors, clinics and laboratories
to diagnose and treat patients, and will allow doctors to customize and modify a
patient's treatment on an ongoing basis.
Our OpenGene System consists of automated DNA sequencers, disposable
gel cassettes, related equipment and software. We also have developed
proprietary disposable test kits, which we call GeneKits, which include the
materials necessary to perform genetic sequencing tests on our system for genes
associated with specific diseases and medical conditions. We already have
developed GeneKits for Human Immunodeficiency Virus (HIV), human leukocyte
antigens (HLA) Class I and II gene complexes (used for organ transplant tissue
typing) and the p53 gene (implicated in many cancers). We are developing
additional GeneKits for human papillomavirus (HPV, implicated in cervical
cancer), Hepatitis B, Hepatitis C and tuberculosis. We own 15 United States
patents which cover our technology and products. The United States Patent and
Trademark office has informed us that it intends to issue an additional three
patents in the near future. We have filed an additional 33 patent applications
covering other aspects of our technology and products.
We target three markets for our products: the research market, the
clinical research market and the clinical diagnostic market. The research market
is engaged in gene discovery and academic research. The clinical research market
develops and commercializes clinical diagnostic tests. The clinical diagnostic
market uses developed, tested products to diagnose and treat disease. Currently,
we sell our products only to the research and clinical research communities.
More than 500 of our sequencing systems are already installed in over 200
laboratories. We have granted Amersham Pharmacia Biotech Ltd. (Amersham) an
exclusive worldwide license to sell one of our DNA sequencers to the research
market.
We plan to sell our products to the clinical diagnostic market in the
United States after receiving approval from the U.S. Food and Drug
Administration. We are applying for an Investigational Device Exemption (IDE)
from the FDA, which is a preliminary step in the FDA approval process. We have
signed contracts to sell HIV GeneKits at six government certified hospital
laboratories in Europe, where products will be evaluated for clinical utility as
part of the European regulatory approval process.
Our principal executive offices are located at 700 Bay Street, Suite
1000, Toronto, Ontario, Canada M5G 1Z6. Our telephone number is: (416) 813-3240.
Our Web site address is www.visgen.com.
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FORWARD-LOOKING STATEMENTS
This Prospectus includes forward-looking statements, regarding, among
other items:
- acceptance of our products in the marketplace
- our marketing and sales plans
- our expectations about the markets for our products
- our intention to introduce new products
- our future capital needs
- FDA approval for certain of our products
- success of our patent applications
- the status of Year 2000 compliance efforts
We have based these forward-looking statements largely on our
expectations.
Forward-looking statements are subject to risks and uncertainties,
certain of which are beyond our control. Actual results could differ materially
from those anticipated as a result of the factors described in the "Risk
Factors" section beginning on page 4, including among others:
- problems that we may face in manufacturing, marketing, and
distributing our products
- uncertainty of market acceptance of our products
- the timing of our future capital needs
- our inability to raise additional capital when needed
- delays in obtaining, or our inability to obtain,
approval by the FDA and other regulatory authorities for
certain of our products
- delays in developing, or the failure to develop, new
products and enhanced versions of existing products
- delays in the issuance of, or the failure to obtain,
patents for certain of our products and technologies
- problems with important suppliers and business partners
We do not undertake any obligation to publicly update or revise any
forward-looking statements contained in this Prospectus or incorporated by
reference, whether as a result of new information, future events or otherwise.
Because of these risks and uncertainties, the forward-looking events and
circumstances discussed in this Prospectus might not transpire.
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RISK FACTORS
The Shares offered by this Prospectus are speculative and involve a
high degree of risk. Before making an investment, you should carefully read this
entire Prospectus and consider the following risk factors.
Risks Relating to Our Business
Early Stage of Commercialization
Although we began operations in 1993, we are only in the early stages
of commercial manufacturing and marketing of our products. Until 1996, we
devoted almost all of our time to research and development of our technology and
products, protecting our proprietary rights and establishing strategic
alliances. In late 1996, we began manufacturing and selling the initial versions
of our automated DNA sequencers and related products and certain GeneKits. Sales
for our 1997 fiscal year were $3.0 million, and for the nine months ended
September 30, 1998, sales were $6.8 million. We cannot assure our investors that
sales will significantly increase or that we will become profitable.
History of Operating Losses and Anticipated Future Losses
We incurred a net operating loss of $11.1 million in 1997 and $10.3
million for the first nine months of 1998. "Net operating loss" represents the
amount by which cost of sales and expenses (other than interest expense) exceed
sales. As of September 30, 1998, our accumulated deficit was $29.7 million. Our
losses have resulted principally from expenses incurred in research and
development of our technology and products, and from selling, general and
administrative expenses that we have incurred while building our business
infrastructure. We expect to continue to incur significant operating losses in
the future as we continue our research and development efforts and expand our
marketing and sales force in an effort to achieve greater sales. Our ability to
achieve profitability depends on our ability to successfully market and sell our
products. It is uncertain when, if ever, we will become profitable. See
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" beginning at page 26.
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Need for Future Capital and Uncertainty of Additional Funding
Since we began operations we have obtained operating funds primarily by
selling shares of our company and borrowing money from investors, banks and
institutional lenders. Since late 1996, a small portion of our operating funds
have come from sales of our products.
At this time, our sales are not sufficient to meet our anticipated
financial requirements. Based on our current plans, we believe that current cash
balances and anticipated funds from operations will be sufficient to meet our
operating needs (excluding repayment of certain indebtedness) for approximately
the next 12 to 18 months. In addition, on April 29, 1999, we must repay a $7.7
million (comprising principal and interest) loan. While we may be able to repay
that loan from our cash balances and anticipated funds from operations, we
cannot be certain at this time that we will be able to do so. Furthermore, the
actual amount of funds that we will need during the next 18 months will be
determined by many factors, some of which are beyond our control, and we may
need funds sooner than currently anticipated. These factors include our success
in selling our products during this period, progress with research and
development, our success in introducing new products during the period, the
costs and timing of obtaining new patent rights, regulatory changes, competition
and technological developments in the market. See "Management's Discussion and
Analysis of Financial Condition and Results of Operations" beginning at page 26.
We anticipate that we will need to obtain additional funds during or at
the end of this 12 to 18 month period. We may also require additional funds to
repay all or a portion of our loan on April 29, 1999. If necessary, potential
sources of additional funding include strategic relationships, refinancing of
the term loan, public or private sales of our shares or debt, or other
arrangements. We do not have any committed sources of additional financing at
this time and it is uncertain whether we can obtain additional funding when we
need it on terms that will be acceptable to us or at all. If we raise funds by
selling additional shares, the ownership interest of our existing shareholders
will be diluted. If we are unable to obtain financing when needed, our business
and future prospects would be materially adversely affected.
Limited Manufacturing Experience
We manufacture our DNA sequencers, certain related equipment and
consumables, and GeneKits. We have limited experience in the large-scale
manufacturing of these products. Since we started manufacturing operations in
1996, we have experienced delays, quality control problems and capacity
constraints from time to time. As production increases and we begin
manufacturing and assembling new products, additional problems may arise. These
may include technological, engineering, quality control and other production
difficulties. If we experience these problems, we could be delayed in filling
orders or shipping existing products and introducing new products to the
marketplace. These problems could also adversely affect customer satisfaction
and consequently the market acceptance of our products.
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Limited Marketing Experience
We have limited experience in marketing products to the clinical
research and research markets and no experience marketing products to the
clinical diagnostic market. We have developed our own sales and marketing staff
and infrastructure which services, primarily, the clinical research and clinical
diagnostic markets. It is uncertain whether our sales and marketing staff will
be able to achieve our sales objectives in a timely and cost-effective manner.
We sell, and plan to sell in the future, our products to the research
market primarily through license arrangements and strategic relationships with
other life sciences companies. Our ability to successfully penetrate the
research market will depend substantially on the efforts of these other
companies. Should these companies be unwilling to sell our products or
unsuccessful in their efforts, our ability to sell to the research market will
be adversely affected. Failure to successfully market our products will likely
impede our ability to generate significant revenues and become profitable.
No Assurance of Additional Product Development
We believe that if we are to become, and then remain, profitable, we
must be able to develop advanced technology, advanced versions of our current
products and new products. These products and technology must be developed and
introduced to the market in a timely and cost-effective manner to meet both
changing customer needs and technological developments. We cannot assure you
that we will be able to successfully or timely develop any of these products or
technology, or that any new products will achieve acceptance in the market. It
is also possible that we will not have sufficient financing to develop new
products. If we are unable to successfully develop products in the future, our
ability to generate significant revenues will be impeded and we could experience
additional significant losses.
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Uncertainty of Protection of Patents and Proprietary Rights
Our success will partly depend on our ability to obtain patents on our
technology, to obtain appropriate licenses from third parties and to protect
trade secrets. We have filed 51 patent applications in the United States. Of
these, 15 patents have already been issued in the United States and we have
received notices of allowance for three applications. A notice of allowance is
granted by the U.S. Patent and Trademark Office if, after examination, it finds
the patent application allowable. The patent is issued as soon as possible after
payment of an issuance fee by the Company, dependent on the backlog of patents
in the Patent and Trademark Office. We have also filed patent application in
various foreign countries. Our foreign patent applications are still pending. We
cannot assure you that our remaining patent applications will result in patents
being issued in the United States or foreign countries. In addition, we cannot
guarantee that patents which have been or will be issued will afford meaningful
protection for our technology and products. Competitors may develop products
similar to ours which do not conflict with our patents. Others may challenge our
patents and, as a result, our patents could be narrowed or invalidated. The
patent position of biotechnology firms generally is highly uncertain, involves
complex legal and factual questions, and has recently been the subject of much
litigation. No consistent policy has emerged from the U.S. Patent and Trademark
Office or the courts regarding the breadth of claims allowed or the degree of
protection afforded under biotechnology patents. In addition, there is a
substantial backlog of biotechnology patent applications at the USPTO and the
approval or rejection of patents may take several years.
Our success will also depend partly on our ability to operate without
infringing upon the proprietary rights of others, as well as our ability to
prevent others from infringing on our proprietary rights. We may be required at
times to take legal action in order to protect our proprietary rights and,
despite our best efforts, we may be sued for infringing on the patent rights of
others. Patent litigation is costly, and, even if we prevail, the cost of such
litigation could adversely affect our financial condition. If we do not prevail,
in addition to any damages we might have to pay, we could be required to stop
the infringing activity or obtain a license. We cannot be certain that any
required license would be available to us on acceptable terms, or at all. If we
fail to obtain a license our business might be materially adversely affected.
To help protect our proprietary rights in unpatented trade secrets, we
require our employees, consultants and advisors to execute confidentiality
agreements. However, we cannot guarantee that these agreements will provide us
with adequate protection if confidential information is used or disclosed
improperly. In addition, in some situations, these agreements may conflict with,
or be subject to, the rights of third parties with whom our employees,
consultants or advisors have prior employment or consulting relationships.
Further, others may independently develop substantially equivalent proprietary
information and techniques, or otherwise gain access to our trade secrets.
Regulation by Government
In the United States, the FDA regulates medical products. Similar
agencies exist in Canada, Japan, and in other countries in Europe and elsewhere.
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Our products can be used in two ways. First, they can be used in
scientific research, to discover new information or develop better ways to
diagnose or treat disease. Second, they can be used in the medical care of
specific patients. In that case, they are called diagnostic medical devices.
Initially, we intend to sell products only for research use. We do not
believe that approval by the FDA or foreign agencies is necessary for sales for
research use. Later, we plan to sell products as diagnostic medical devices. For
that, we believe that government approval will be required.
To obtain FDA approval of a new medical device in the United States, a
company must generally submit proof of safety and efficacy. In some cases, this
proof consists of extensive tests in animals and then in humans. Results of
clinical trials and other information must be described in a detailed
application, which the FDA evaluates before deciding whether to approve the
medical device. This process is expensive and may take several years.
We cannot assure you that the FDA will approve any of our products as
diagnostic medical devices, or do so in a timely way. First, the tests may fail
to prove that a particular product is safe and effective. Second, it may be too
expensive for us to conduct all the necessary tests. Third, there may be delays,
or disagreements between the Company and the FDA about whether the tests are
adequate. Because of these uncertainties, you should assume that we may
experience delays in obtaining FDA approval, or that we may not get FDA approval
to sell our products as diagnostic medical devices.
We initiated the FDA approval process in April 1998 by filing for an
Investigational Device Exemption, which is necessary to begin clinical trials
required as part of the approval process. The FDA has requested additional
information and we are in the process of resubmitting the application in
response to the FDA's request.
We also plan to market products outside the United States, initially in
Canada, Europe and Japan. Government approval for diagnostic medical devices in
most foreign countries may require lengthy and costly testing similar to what
the FDA requires. In addition, foreign agencies may have different policies than
the FDA, and may be influenced by domestic politics. Because of these factors,
we may not be able to get products approved for marketing in foreign countries.
To date, we have not sought approval from the FDA or any foreign agencies for
the commercial sale of any of diagnostic medical device products.
Other government agencies also impose regulations that affect our
business, especially in Canada, where we are located. These regulations relate
to the following activities, among others:
- worker compensation
- safe working conditions
- laboratory and manufacturing practices
- use and disposal of hazardous chemicals or infectious disease
agents
Aside from government agencies, there are trade and other groups
interested in making recommendations about the regulation of genetic diagnostic
testing, or developing industry-wide standards for testing. We are aware of
ongoing discussions within these groups, and between them
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and government agencies, concerning the need for more rules in this area.
You should assume that in the future there may be more government
regulations or industry standards affecting genetic diagnostic testing than
there are now. Additional or more stringent regulations could have a negative
effect on our ability to gain approval to sell diagnostic medical device
products. They could also increase our cost of doing business or have other
adverse effects on our business.
Dependence on Third Parties for Supplies and Technology; Limited
Supply of Certain Dyes and Parts
Dyes. We sell some dyes manufactured by Amersham in our GeneKits and as
component parts. Amersham has granted us an exclusive worldwide license to use
and sell some of its dyes in our GeneKits and a non-exclusive license to use and
sell in North America some dyes in conjunction with our DNA sequencers. Our
license agreements with Amersham expire in April 1999, but are renewable
automatically each year unless either of us notifies the other at least six
months in advance of renewal that it wishes to terminate the license. If this
arrangement is terminated, we may be able to replace some Amersham dyes with
dyes from other manufacturers. We also believe that our customers may be able to
purchase some, but not all, of the dyes directly from Amersham. However, we
cannot guarantee that we or our customers will be able to do so. Even if our
customers are able to acquire dyes directly from Amersham, we believe that our
marketing efforts may be adversely affected if we are unable to include the
Amersham dyes in our GeneKits. If Amersham cancels this arrangement and we
cannot include alternative dyes in our GeneKits, we do not believe that we would
be able to generate the same amount of potential revenue from the clinical
research and clinical diagnostic markets as we currently anticipate.
Polymerase Chain Reaction Technology. We also have entered into
licensing agreements with Roche Molecular Systems, Inc. and F. Hoffmann -
LaRoche Ltd. to use an important technology developed by the Roche companies
called Polymerase Chain Reaction technology. Under the first licensing
agreement, the Roche companies granted us a worldwide license to develop, market
and sell GeneKits that use the Polymerase Chain Reaction technology. The license
limits our use of this technology to specific types of diagnostic functions. The
license is not exclusive, and, therefore, may be granted by the Roche companies
to our competitors and others. We are required to pay royalties to the Roche
companies under this agreement. This license is for the life of the patents
included within the licensing agreement, except that the Roche companies may
terminate the agreement if there were to be a change of control of our company
or under certain other circumstances. The patents included within the licensing
agreement in the United States expire at various times commencing July 2004.
The Roche companies also have granted us a non-exclusive license to use
Polymerase Chain Reaction technology in connection with the manufacture and sale
of GeneKits. We are required to pay royalties to Roche under this arrangement.
This agreement expires in February 2003 but will be automatically extended until
July 2004, unless the Roche companies elect not to renew the agreement. After
the expiration of the initial term, the Roche companies may terminate the
license at any time by giving one year's notice.
The termination of either of these agreements would have a material
adverse effect on our
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ability to produce GeneKits. Consequently, we could experience a deterioration
of anticipated future sales of our GeneKits and further losses.
Custom Parts. Certain parts used in our DNA sequencers and related
equipment are custom designed for us by suppliers. While we believe that there
are alternative suppliers for these custom-designed parts, we would incur costs
that may be material if we had to switch to alternative suppliers. We would also
likely experience delays in production of the products that use any of these
custom parts until such time as we were able to locate alternate suppliers or
parts.
Competition
The biotechnology industry is highly competitive. We compete with
companies in the United States and abroad that are engaged in the development
and production of products that analyze genetic information. They include:
- biotechnology, pharmaceutical, chemical and other companies;
- academic and scientific institutions;
- governmental agencies; and
- public and private research organizations.
Some of our major competitors include:
- manufacturers and distributors of probe-based diagnostic
systems such as Abbott Laboratories, Chiron Corp., Hoffman
- La Roche Inc., Gene Probe Inc. and Johnson & Johnson;
- manufacturers and distributors of DNA sequencers such as the
Applied Biosystems division of Perkin Elmer, Amersham and its
Molecular Dynamics subsidiary, LI-COR, Inc., Hitachi, Ltd.,
Molecular and Genetic BioSystems, Inc.; and
- manufacturers of new technologies, such as chip-based and
assay-based technologies, including, Hyseq Inc., Affymetrix
Inc., ChemCore Inc., Curagen Corp. and Nanogen, Inc.
Many of these companies and many of our other competitors have much
greater financial and technical resources and production and marketing
capabilities than we do.
Our GeneKits include material needed to perform tests to identify
mutations for specific genes. Many of our competitors, as well as other
companies and institutions, identify specific gene sequences and seek patent
protection for those sequences or entire genes. In some cases, patents granted
to others may prevent us from developing additional GeneKits for those patented
genes or gene sequences or may require us to pay license fees or royalties to
use in our GeneKits the genes subject to those patents. These fees or royalties
could be significant and effectively prohibit us from obtaining the license. If
we are required to pay fees or royalties, our profit margin for the specific
GeneKits may be lowered and, in some cases, may make it impractical to produce
the GeneKit profitably.
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Our GeneKits also compete with "home-brew" genetic tests for HIV and
other diseases. Home-brew tests include a variety of small-scale genotyping
tests which have not undergone clinical validation and have not been approved by
the FDA or other regulatory agencies.
Uncertainty of Reimbursement by Insurance Companies and Third Party Payors
Whether we can obtain adequate insurance reimbursement for tests will
impact how successful we are in selling products to the clinical diagnostic
market. We will seek reimbursement from government and private health care
insurers (including health maintenance organizations) and other third-party
payors. Physicians' decisions to recommend genetic tests, as well as patients'
elections to pursue testing, are likely to be heavily influenced by the
availability of reimbursement for such tests by third-party payors. Government
and private third-party payors are increasingly attempting to contain health
care costs by limiting both the extent of coverage and the reimbursement rate
for new testing and treatment products and services. In particular, services
which are determined to be investigational in nature or which are not considered
"reasonable and necessary" for diagnosis or treatment may be denied
reimbursement coverage. It is uncertain whether insurers or third-party payors
will elect to provide full reimbursement coverage for our genetic tests in the
near future. If adequate reimbursement coverage is not available from insurers
or third-party payors, it is uncertain whether patients will elect to directly
pay for the test. If insurers or third-party payors and patients are unwilling
to pay for the tests, then the number of tests performed will be significantly
decreased. As a result, anticipated revenues will be reduced and our ability to
achieve profitability will be impaired.
Uncertainty About the Widespread Use of Genetic Testing and Potential
Discrimination by Insurance Companies and Others
The use of genetic testing has raised ethical issues regarding
confidentiality and the appropriate uses of the information provided by tests.
Certain of our tests may be used, in the future, in the early stages of
diagnosing a disease or medical condition. Insurers with knowledge of
unfavorable results of a genetic test may respond by raising insurance premiums
to prohibitive levels or canceling a patient's insurance. The decision of a
patient to consent to undergo a genetic diagnostic test could be heavily
influenced by how the patient perceives an insurer will react to unfavorable
results. If insurance discrimination were to become a significant barrier to the
acceptance of diagnostic genetic testing, we could experience delays in market
penetration or a reduction in the size of our potential market. As a result, it
would be unlikely that we would be able to generate significant revenues and
losses would likely continue. Similarly, employers could discriminate against
employees with genetic predispositions to diseases or medical conditions in an
effort to avoid any increases in health insurance costs, or the potential of
lost time on the job. For these reasons, governmental authorities may call for
limits on the use of genetic testing or prohibit testing for genetic
predisposition to certain conditions. In any of these scenarios, we could
experience delays in market acceptance of our products, which could materially
adversely affect our prospects.
11
<PAGE>
Dependence on Qualified Personnel and Consultants
Because of the specialized scientific nature of our business, we are
highly dependent upon our ability to attract and retain qualified scientific and
technical personnel. We also must hire additional qualified management,
marketing and sales personnel as our business expands. Competition in our
industry for scientific, marketing and sales and management personnel is
intense. Loss of the services of Dr. John K. Stevens or key members of his staff
could adversely affect our research and development and sales and marketing
programs and could impede the achievement of our goals. We do not maintain key
man life insurance on any of our personnel.
Risks Associated With Managing Our Anticipated Growth
If we are successful in increasing sales and expanding our markets,
there will be additional demands on our management, customer support, marketing,
distribution and other operational and administrative resources and systems. To
accommodate future growth, we may have to hire a substantial number of
additional management and other employees in the United States and abroad. We
cannot guarantee that we will be able to hire a sufficient number of qualified
personnel. In addition, it is uncertain whether our administrative, operational,
infrastructure and financial resources and systems will be adequate to maintain
and effectively monitor future growth. The occurrence of unexpected or material
expansion difficulties could have a material adverse effect on our business and
prospects.
Potential Product Liability
The manufacturing and sale of our products exposes us to the risk of
product liability claims. Although we have obtained product liability insurance
coverage, we cannot guaranty that product liability insurance will continue to
be available to us on acceptable terms or that our coverage will be sufficient
to protect against all claims against us. A product liability claim, even one
without merit or for which we have substantial coverage, could result in
significant legal defense costs, thereby increasing our expenses, lowering our
earnings and, depending on revenues, potentially resulting in additional losses.
Risks Relating to Share Ownership
Control by Management and Existing Shareholders
Our directors, executive officers and existing principal shareholders
own, together, approximately 9% of the outstanding Common Shares. Another
company, of which one of our directors is a principal shareholder, officer and
director, beneficially owns approximately 21% of our Common Shares. If they act
together, these shareholders may be able to effectively control our management
and company policies, including matters requiring shareholder approval, such as
the election of directors, the approval of certain mergers and other significant
corporate transactions and a sale of substantially all of our assets. Control by
these shareholders could have the effect of delaying or preventing a change in
control or sale of our company.
12
<PAGE>
Our Unlimited Preferred Shares and Classified Board of Directors Could Prohibit
Takeovers
Our authorized capital consists of an unlimited number of Common Shares
and an unlimited number of preferred shares. The Board of Directors, without any
further vote by the shareholders, has the authority to issue preferred shares
and to determine the price, preferences, rights and restrictions, including
voting and dividend rights, of these shares. The rights of the holders of Common
Shares are subject to the rights of holders of any preferred shares that the
Board of Directors may issue in the future. That means, for example, that we can
issue preferred shares with more voting rights, higher dividend payments or more
favorable rights upon dissolution, than the Common Shares. If we issued certain
types of preferred shares in the future, it may also be more difficult for a
third party to acquire a majority of our outstanding voting shares. See
"Description of Capital Shares" at page 34.
In addition, we have a "classified" Board of Directors, which means
that only one-third of our directors are eligible for election each year.
Therefore, if shareholders wish to change the composition of the Board of
Directors it would take at least two years to remove a majority of the existing
directors, and three years to change all directors. Having a classified Board of
Directors may, in some circumstances, deter or delay mergers, tender offers or
other possible transactions which may be favored by some or a majority of our
shareholders.
Market and Currency Risks
Volatility of Stock Market Could Drive Down Price of Common Shares
The market prices for securities of life sciences companies,
particularly those that are not profitable, have been highly volatile,
especially recently. Publicized events and announcements may have a significant
impact on the market price of our Common Shares. For example, announcements
publicizing poor quarterly financial results, biological or medical discoveries
by competitors, failed technological innovations, unfavorable developments
concerning patents or other proprietary rights or unfavorable domestic or
foreign regulatory developments, may have the effect of temporarily or
permanently driving down the price of a company's stock. In addition, the stock
market from time to time experiences extreme price and volume fluctuations which
particularly affect the market prices for emerging and life sciences companies,
such as ours, and which are often unrelated to the operating performance of the
affected companies. These broad market fluctuations may adversely affect the
ability of a shareholder to dispose of his shares at a price equal to or above
the price at which the Shares were purchased.
Future Sale of Eligible Shares may Lower Price of Common Shares
We have outstanding 9,183,289 Common Shares, not including the Shares
covered by this Prospectus. Of these Shares, 7,358,497 are eligible for sale
under Rule 144 or are otherwise freely tradable. The 76,734 shares covered by
this Prospectus will be issued upon exercise of warrants held by the selling
shareholders, and, will be freely tradable so long as we keep the Registration
Statement (of which this Prospectus is a part) current and effective. In
addition:
13
<PAGE>
- On November 20, 1998 we filed a Registration Statement with the
Securities and Exchange Commission registering 1,528,989 Common
Shares issued to certain shareholders of the Company in a private
placement completed on that date. These shares may be freely sold,
for so long as that registration statement is effective and
current.
- Our employees (who are not deemed affiliates) hold options to buy
a total of 1,420,000 Common Shares. The Common Shares to be issued
upon exercise of these options, have been registered, and therefore
may be freely sold when issued;
- In addition to the warrants held by the selling shareholders,
there are outstanding warrants to buy 661,951 Common Shares. The
holders of these warrants have certain rights to have the shares
issuable upon exercise of their warrants registered in certain
registration statements.
- We may issue options to purchase up to an additional 250,000
Common Shares under our stock option plans, which also will be
fully saleable when issued.
Sales of substantial amounts of Common Shares into the public market
could lower the market price of our Common Shares.
Potential for Losses Due to Foreign Currency Exchange Risks
Our functional currency and reporting currency is the U.S. dollar.
However, we do incur some expenses in Canadian dollars and in other foreign
currencies. We also sell products to customers in foreign countries and bill
those customers in local currencies at predetermined exchange rates. As our
business expands, we anticipate that we will increasingly incur expenses and
bill and receive payments in local currencies at prevailing exchange rates. As a
result, we are exposed, and will continue to be exposed, to risk due to
fluctuations in the exchange rates between the U.S. dollar and the Canadian
dollar and the U.S. dollar and the currencies of such other countries. We
currently engage in very limited foreign exchange hedging activities to protect
ourself against the risk of losses due to fluctuations in exchange rates by
purchasing Canadian funds before they are actually required. We do not currently
engage in hedging activities for any other foreign currencies. We cannot
guaranty that we will not suffer losses as a result of unfavorable fluctuations
in the exchange rates between the U.S. dollar and the foreign currencies in
which we incur expenses and bill and receive payments.
14
<PAGE>
INFORMATION ABOUT THE COMPANY
For a detailed description of our business and information about our
management, see our Annual Report which is incorporated into this Prospectus by
reference. The following information supplements or supersedes, as may be
appropriate, the information contained in our Annual Report.
Products and Technology
The following table lists the status of our products:
<TABLE>
<CAPTION>
- ------ ----------------------------------------------------------------------- ----------------------------------
PRODUCT STATUS(1)
OpenGene-TM- Automated DNA Sequencing System
<S> <C>
Clipper-TM-Automated DNA Sequencer Launched
MicroGene Blaster-TM-Automated DNA Sequencer Launched
Long-Read Tower-TM-Automated DNA Sequencer Pre-Launch
MicroCel-TM-Cassette Launched
Long-Read MicroCel-TM-Cassette Pre-Launch
SureFill-TM-Cartridge Launched
Gel Toaster-TM-Polymerization Unit Launched
GeneObjects-TM-DNA Analysis software Launched
- ------- ----------------------------------------------------------------------- ---------------------------------
GeneKits
HIV Genotyping GeneKit Launched
HLA Class I and II (organ transplant tissue typing) GeneKit Launched
p53 (various cancers) GeneKit Launched
Human papillomavirus (HPV-cervical cancer) GeneKit Clinical Development
Hepatitis B GeneKit Pre-Clinical Development
Hepatitis C GeneKit Pre-Clinical Development
Tuberculosis Pre-Clinical Development
- ------- ----------------------------------------------------------------------- ---------------------------------
</TABLE>
- --------------
(1) Products launched to date are for research purposes only. Sales of the
products for diagnostic use will require FDA approval in the United States
and approvals from comparable regulatory authorities in other countries.
Long-Read Tower Automated DNA Sequencer and Long-Read MicroCel
Cassettes. In September 1998, we announced the introduction of a new automated
DNA sequencer, which we call the Long-Read Tower. This sequencer is a two-dye
automated sequencer that can perform all of the applications of our existing
Clipper sequencer, and can also read longer bases used in some research
applications. Using our Long-Read MicroCel cassettes, the Long-Read Tower can
read 1,000 bases with high accuracy, almost three times faster than competitive
instruments. The Long-Read Tower may be networked with other Long-Read Towers or
Clippers, providing a high degree of flexibility and capacity. The Long-Read
Tower is small (22cm x 24cm x 45cm) and lightweight relative to competitive
instruments, and sells at retail prices significantly below comparable
15
<PAGE>
automated DNA sequencers. We have applied for FCC, Underwriters Laboratories and
Canadian Standard Association approval for the Long-Read Tower. We expect to
begin selling the Long-Read Tower in the research and clinical research markets
beginning in the first quarter of 1999.
Additional Information About HIV GeneKits. Our HIV GeneKit identifies
genetic mutations (changes) of HIV. One of the characteristics of HIV is that
the virus reproduces rapidly and the DNA codes change quickly and often. The
treatment of patients infected with HIV and those who have developed the
symptoms of Acquired Immune Deficiency Syndrome (AIDS) poses an enormous global
challenge given the number of infected people as well as the speed at which the
virus changes. At present, over 30 million people are infected with HIV
worldwide. In North America, the U.S. government estimates that approximately
one million people carry the virus and we estimate that approximately 250,000
people are currently undergoing active treatment. HIV/AIDS research has led to
the development of a number of promising therapies. However, in many cases, the
high rate of mutation of HIV leads to resistance to such treatments. Currently,
over 140 strains of drug-resistant HIV have been identified. One of the main
challenges in maintaining HIV/AIDS patients on long-term therapy is to detect
the emergence of the drug resistant strain of the virus early and adjust the
patient's medication to combat the changes. We believe that periodic monitoring
using DNA sequencing tests of the type included in our HIV GeneKit will enable
doctors to modify treatment in advance of changes in physical symptoms, and will
create an opportunity to improve a patient's clinical outcome while lowering
treatment costs.
Boom Technology. In May 1998, Organon Teknika, a life science company
based in Belgium, gave us a license to include, with our GeneKits, nucleic acid
extraction kits based on Boom technology. This technology enables sensitive,
reproducible and accurate extractions of RNA and DNA from blood plasma samples,
and RNA from sterile body fluids such as semen and cerebral spinal fluid. RNA
and DNA are forms of nucleic acid which store the genetic information which our
sequencers read. The Boom method is especially valuable in extracting the RNA
and DNA from HIV patients with low viral levels. The license is for an initial
term of two years. In exchange for the license, we are required to pay fees and
royalties to Organon Teknika for use of the Boom technology and to give Organon
Teknika a right of first refusal to certain improvements to DNA sequencing
technology and extraction technology which we may develop and to certain
reagents and uses of our CLIP technology.
Additional Testing and Sequencing Services
In April 1998, we acquired ACT Gene S.A., a DNA diagnostics testing and
sequencing company based in Evry, France. ACT Gene has developed, and is in the
process of developing additional, DNA diagnostic tests covering various diseases
and medical conditions. Its diagnostic testing services include genotyping tests
for HIV, hepatitis C, HPV, p53, BRCA1 and BRCA2 (implicated in breast cancer)
and other tests.
In December 1998 we and Virology Networks agreed to form a new
company that will produce traceable quality control and quantitative standards
for identifying HIV, Hepatitis B, Hepatitis C, CMV (cytomegalovirus, a herpes
virus) and other infectious organisms. These standards are used by laboratories
to monitor the quality of the results of tests they conduct to identify
infectious diseases. It is anticipated that the new company will also develop
a large-scale database of HIV genotypes in Europe and the United States of new
and existing HIV mutations and their resistance to specific
16
<PAGE>
HIV drugs. In addition, the new entity will work to develop new methods and
technology for long term, stabilized RNA storage and will also provide
independent statistical analysis of test results.
Virology Networks is based in the Netherlands, and was founded by
Dr. Charles A. B. Boucher and Tom S. Schwartz. Both of them will be involved
in the new entity. We will receive a 51% interest in the new entity and will
control its board of directors, in exchange for our commitment to finance the
development of the business. In addition, we will issue to the shareholders of
Virology Networks 35,000 Common Shares. We expect to enter into definitive
agreements and begin operations of the new entity during 1999.
Human Resources
As of October 1, 1998, we employed 148 permanent employees and 43
contract employees, of whom 60 are actively engaged in research and development,
30 are involved in sales and marketing activities, 73 are in manufacturing and
operations and 28 are involved in finance, legal, regulatory and administrative
functions.
Facilities
The table below lists the locations of our facilities and summarizes
some of the significant lease terms for each location.
<TABLE>
<CAPTION>
- ------------------------------------ ---------------------- ------------------- -------------------------- -----------------------
Location Usage Square Minimum Term of Lease
Feet Gross
(approximate) Annual Rent(1)
(approximate)
<S> <C> <C> <C> <C>
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
1. Bay Street Research & Executive 20,625 Year 1 Cdn $360,000 Expires May 31, 2000
Toronto, Canada Offices Year 2 Cdn $467,000
Year 3 Cdn $194,825
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
2. Etobicoke Manufacturing 10,282 Year 1 Cdn $65,000 September 1997 -
Toronto, Canada Year 2 Cdn $70,000 September 2002
Year 3 Cdn $73,000
Year 4 Cdn $75,000
Year 5 Cdn $78,000
- ------------------------------------ ---------------------- ------------------- -------------------------- -------------------------
3. Etobicoke Clipper Production 10,430 Year 1 Cdn $29,000 September 1998 -
Toronto, Canada Year 2 Cdn $86,000 September 2002
Year 3 Cdn $86,000
Year 4 Cdn $86,000
Year 5 Cdn $57,000
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
4. Oakville Research and 8,000 Year 1 Cdn $21,000 September 1998 -
Ontario, Canada Development Year 2 Cdn $62,500 September 2003
Year 3 Cdn $62,500
Year 4 Cdn $62,500
Year 5 Cdn $42,000
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
5. University of Pittsburgh Manufacturing, 8,171 Year 1 $97,000 September 1997 -
Applied Research Center Research and Year 2 $101,000 August 31, 2000
Pittsburgh, Pennsylvania Development Year 3 $68,000
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
</TABLE>
17
<PAGE>
<TABLE>
<CAPTION>
- ---------------------------------------------------------------------------------------------------------------------------------
Location Usage Square Minimum Term of Lease
Feet Gross
(approximate) Annual Rent1
(approximate)
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
<S> <C> <C> <C> <C>
6. Technology Park Research and 7,313 Year 1 $75,000 March 1998 -
Norcross, Georgia Development Year 2 $91,000 March 2003
Year 3 $94,000
Year 4 $96,000
Year 5 $98,000
- ------------------------------------ ---------------------- ------------------- -------------------------- ----------------------
</TABLE>
- ----------------
1 Gross Rent includes property taxes, maintenance and insurance, and, in the
case of the Bay Street facility, is subject to escalation for inflation.
Our subsidiary, ACT Gene S.A., maintains offices in Evry,
France.
Our current facilities are adequate to meet expected production demands
through 1999. Thereafter, we anticipate that we will need additional research
and office space and manufacturing facilities. We believe that at that time
additional facilities will be available at reasonable market rates.
New Director
In June, 1998, Richard T. Daly was appointed to our Board of
Directors. Mr. Daly, 48, has spent 15 years in the health-care industry in a
variety of executive positions. In 1989 Mr. Daly founded, and he currently
serves as Chief Executive Officer and Chairman of the Board of, Clinical
Partners, Inc. a San Francisco-based company providing comprehensive,
therapy-specific management of HIV and AIDS patients for employers and
managed health-care organizations in California and Texas. Mr. Daly holds a
BS in finance from New York University and an M.B.A. from the Harvard School
of Business Administration. Our company and Clinical Partners entered into an
agreement in March 1998 pursuant to which we have paid Clinical Partners
$210,000 during 1998. This arrangement is described in more detail in our
Annual Report.
Service and Enforcement of Legal Process
Our company is incorporated under the laws of the Province of Ontario,
Canada and a substantial portion of our assets are located in Canada. Certain
of our directors and officers and certain of the experts named in this
Prospectus are residents of Canada, and all or a substantial portion of their
assets are located outside the United States. As a result, if any of our
shareholders were to bring a lawsuit against our officers, directors or
experts in the United States it may be difficult for them to effect service
of legal process within the United States upon those people who are not
residents of the United States or to realize in the United States upon
judgments of courts of the United States based upon civil liability under the
Securities Act of 1933, as amended, or the Securities Exchange Act of 1934,
as amended (including the rules promulgated thereunder by the Commission). In
addition, our attorneys in Canada, Goldman, Spring, Schwartz & Kichler, have
advised us that a judgment of a United States court based solely upon civil
liability under these laws would probably be enforceable in Canada if the
United States court in which the judgment were obtained had a basis for
jurisdiction in the matter that was recognized by a Canadian court for such
purposes. Our attorneys have also advised us that, in their opinion, there is
substantial doubt
18
<PAGE>
whether an action could be brought successfully in Canada in the first instance
on the basis of liability predicated solely upon such laws.
19
<PAGE>
CONSOLIDATED UNAUDITED FINANCIAL STATEMENTS
We have included below our consolidated unaudited balance sheet at
September 30, 1998 and consolidated audited balance sheet at December 31,
1997. We have also included our consolidated unaudited statement of
operations and statement of cash flows for the nine months ended September
30, 1997 and 1998. Our financial statements have been prepared in accordance
with United States generally accepted accounting principles (GAAP). These
financial statements include all adjustments, consisting of normal recurring
accruals, which we consider necessary for a fair presentation of our
financial position and the results of operation for these periods. Operating
results for the nine months ended September 30, 1998 are not necessarily
indicative of the results that may be expected for the entire year ending
December 31, 1998. The financial information set forth below should be read
in conjunction with the section of this Prospectus entitled "Management's
Discussion and Analysis of Financial Conditions and Results of Operations"
and with our financial statements for the years ended December 31, 1997 and
1996 included in our Annual Report.
In the notes to our financial statements and in certain other places in
this Prospectus, we refer to our company as "the Company" or "VGI."
20
<PAGE>
VISIBLE GENETICS INC.
CONSOLIDATED BALANCE SHEET
(Unaudited)
<TABLE>
<CAPTION>
September 30, December 31,
1998 1997
------------- ------------
<S>
ASSETS <C> <C>
Current assets
Cash and cash equivalents $ 2,504,834 $ 1,866,679
Short-term investments -- 5,721,222
Trade receivables 3,917,311 2,066,685
Other receivables 543,570 244,285
Prepaid and deposits 591,353 215,993
Inventory 2,734,706 772,514
------------- -------------
Total current assets 10,291,774 10,887,378
Fixed assets 3,395,748 1,450,980
Patents and licenses 2,083,388 1,598,014
------------- -------------
$15,770,910 $13,936,372
------------- -------------
------------- -------------
LIABILITIES
Current liabilities
Notes payable $ 6,901,885 $ --
Trade payables 3,143,969 1,111,912
Accrued liabilities 703,015 194,913
Obligation under capital lease -- 19,815
------------- -------------
Total current liabilities 10,748,869 1,326,640
------------- -------------
Long-term debt
Notes payable 1,346,328 --
------------- -------------
SHAREHOLDERS' EQUITY
Share capital 32,455,781 31,281,622
Other equity 983,331 588,406
Deficit (29,763,399) (19,260,296)
------------- -------------
3,675,713 12,609,732
------------- -------------
$15,770,910 $13,936,372
------------- -------------
------------- -------------
</TABLE>
21
<PAGE>
VISIBLE GENETICS INC.
CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Nine months ended September 30
-----------------------------------
1998 1997
---- ----
<S> <C> <C>
Sales $ 6,797,010 $ 1,730,684
Cost of sales 4,405,729 1,272,999
----------- ------------
Gross margin 2,391,281 457,685
----------- ------------
Expenses
Sales, general and administrative 7,655,307 4,892,581
Research and development 4,304,593 2,946,217
Acquired research and development 700,000 --
------------ ------------
12,659,900 7,838,798
------------ ------------
Loss from operations before interest (10,268,619) (7,381,113)
Interest income 200,046 617,615
Interest and financing expense (434,530) --
------------ ------------
Net loss for the period $(10,503,103) $(6,763,498)
------------ ------------
------------ ------------
Weighted average number of common
shares outstanding 7,416,393 7,009,064
------------- -------------
Basic and fully diluted loss per share $ (1.42) $ (0.96)
------------- -------------
------------- -------------
</TABLE>
22
<PAGE>
VISIBLE GENETICS INC.
CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Nine months ended September 30
-------------------------------------------
1998 1997
--------------- ---------------
<S> <C> <C>
Cash provided by (used in)
Operating activities
Net Loss for the period $(10,503,103) $(6,763,498)
Add: Items not involving cash -
Depreciation 736,522 310,163
Amortization 157,518 97,877
Deferred compensation cost related to
options granted 57,774 212,980
Deferred financing expense related to
warrants granted 136,667 --
In-process research and development
acquired 490,875 --
Increase (decrease) from changes in -
Trade receivables (1,850,626) (403,766)
Other receivables (299,285) (127,022)
Prepaid and deposits (375,360) (143,457)
Inventory (1,962,192) (575,148)
Refundable investment tax credits -- 496,993
Accounts payable 2,032,057 6,466
Accrued liabilities 508,102 123,899
-------------- -------------
(10,871,051) (6,764,513)
-------------- -------------
Financing activities
Common shares issued 683,284 235,931
Other equity issuances (37,706) --
Short term borrowings 7,093,218 --
Capital lease obligations (19,815) (15,370)
Long-term debt 1,393,185 --
-------------- --------------
9,112,166 220,561
-------------- --------------
Investing activities
Short-term investments 5,721,222 4,755,096
Fixed assets (2,680,532) (561,562)
Patents and licenses (643,650) (749,280)
-------------- --------------
2,397,040 3,444,254
-------------- -------------
Increase (decrease) in cash during the period 638,155 (3,099,698)
Cash, beginning of period 1,866,679 8,826,602
-------------- -------------
Cash, end of period $ 2,504,834 $ 5,726,904
-------------- -------------
-------------- -------------
</TABLE>
23
<PAGE>
Notes to Consolidated Unaudited Financial Statements
Note 1 Acquisition
In April 1998, the Company acquired 100% of the shares of ACT
Gene S.A., a Paris, France-based DNA diagnostics and contract
sequencing company specializing in HIV genotyping, in exchange
for $450,000 and 85,000 Common Shares. The acquisition was
accounted for using the purchase method, and consequently
revenues and expenses from the date of acquisition are
included in the consolidated financial statements. The
acquisition resulted in the recording of goodwill of $145,000
which is amortized over its expected useful life of five
years, and in-process research and development of $700,000
which was charged to operations at the time of the
acquisition. The Company is still in the process of finalizing
the purchase price allocation.
Note 2 Term Loan
On April 30, 1998, the Company, through its United States
subsidiary, Visible Genetics Corp. ("VGC"), entered into a
term loan agreement with certain institutional lenders (the
"Lenders") pursuant to which the Lenders loaned VGC $7.0
million. The loan bears interest at 10% per annum, and
interest and principal are payable in full on April 29, 1999.
The loan is guaranteed by VGI, and VGI's guarantee is secured
by a security interest in substantially all the assets of VGI,
including the stock of VGC. The loan and guarantee impose
certain restrictive covenants on VGI and VGC, including a
limit on the total indebtedness which VGI and VGC may incur.
In connection with the loan, VGI issued warrants to the
Lenders to purchase an aggregate of 420,000 Common Shares at
an exercise price of $10.00 per share. The warrants are
exercisable through April 30, 2003. On September 28, 1998, the
term loan facility was extended under similar terms and the
Company borrowed an additional $1.0 million under the expanded
loan facility. The additional loan will be due on December 28,
1999. As a condition to the additional loan, the Company
issued to the lenders warrants to buy 120,000 Common Shares at
an exercise price of $10.00 per share. The Company is not
entitled to borrow any additional funds under the expanded
facility.
The proceeds received from the term loan have been accounted
for as required by GAAP, as follows. For the April 30, 1998
portion of the term loan, the Company has allocated $328,000
of the proceeds to warrants and deferred financing expense,
the latter being amortized to income over the 12 month term of
the loan. For the September 28, 1998 portion of the term loan,
the Company allocated $94,000 of the proceeds to warrants and
deferred financing expense, the latter being amortized to
income over the 15 month term of the loan.
24
<PAGE>
<TABLE>
<CAPTION>
Note 3 Inventory
September 30, 1998 December 31, 1997
------------------ -----------------
<S> <C> <C>
Finished goods $ 808,494 $136,185
Work in process 497,175 135,988
Raw materials 1,429,036 500,341
------------------ -----------------
$2,734,705 $772,514
------------------ -----------------
------------------ -----------------
</TABLE>
<TABLE>
<CAPTION>
Note 4 Share Capital
Number of Average Amount
common shares issue price
------------------- ----------------- -------------
<S> <C> <C> <C>
Balance, December 31, 1997 7,248,696 $31,281,622
Issued for cash under stock
option agreements 320,604 $2.13 683,284
Issued for acquisition of ACT
Gene S.A. 85,000 $5.78 490,875
--------- ------------
Balance, September 30, 1998 7,654,300 $32,455,781
--------- ------------
--------- ------------
</TABLE>
Note 5 Subsequent Events
On November 20, 1998, the Company completed a private offering
of 1,528,989 Common Shares. The Company received net proceeds
of approximately $14,060,000, after fees to the placement
agent and other expenses of the offering.
25
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The following is a discussion of our financial condition and results of
operations for the nine months ended September 30, 1998 and the comparable
period in 1997. This information is intended to supplement Item 7 of our Annual
Report. This discussion should be read in conjunction with financial statements
and notes thereto and the other information included elsewhere in this
Prospectus and in the Annual Report.
Overview
Our company was incorporated in April 1993 to develop, manufacture and
market automated DNA sequencing systems. We currently sell our OpenGene System
and GeneKits to the research and clinical research markets.
Since our formation, we have devoted substantially all of our resources
to research and development, establishing collaborative arrangements, protecting
our proprietary rights and commencing the manufacture, marketing and sale of the
OpenGene System and GeneKits. We have incurred losses since inception, and at
September 30, 1998 had an accumulated deficit of $29.8 million. We anticipate
that we will incur additional losses as we continue our research and development
programs, develop our manufacturing operations, and expand our sales and
marketing efforts. We expect that sales levels and losses will fluctuate from
quarter to quarter and that such fluctuations may be substantial.
Our functional currency and reporting currency is the United States
dollar. Therefore, the information set forth in this Prospectus is expressed in
United States dollars, unless stated otherwise. Certain information in this
Prospectus is expressed in Canadian dollars. On September 30, 1998, the exchange
rate for the Canadian dollar to the U.S. dollar based on the noon buying rate in
New York City for cable transfer in Canadian dollars as certified for customs
purposes by the Federal Reserve Bank of New York (the "exchange rate") was
Cdn$1.5262.
Effective October 1997, we acquired Applied Sciences, Inc., an
Atlanta-based diagnostics company specializing in HIV genotyping. In April 1998,
we acquired ACT Gene S.A., a Paris, France-based diagnostics and contract
sequencing company specializing in HIV genotyping. These acquisitions were
accounted for using the purchase method of accounting, and consequently sales
and expenses from the dates of the acquisitions are included in the interim
financial statements.
26
<PAGE>
Results of Operations
Comparison of the nine months ended September 30, 1998 and 1997
Sales increased to $6.8 million for the nine months ended September 30,
1998, compared with $1.7 million for the same period of the prior year, an
increase of 292%. The increase resulted from sales of our Clipper and Seq 4x4
automated DNA sequencers which were introduced in the Fall of 1997 and early
1998, respectively, along with an increase in sales of the consumables and
GeneKits. ACT Gene revenues of $0.6 million are included in 1998 sales, compared
to nil in the prior year. In the nine months ended September 30, 1998, 318
automated sequencing systems were sold, an increase of 354% from the 70 systems
sold in the same period of the prior year. In the nine months ended September
30, 1998, automated sequencing systems accounted for 72% of total sales,
compared to approximately 85% of total sales in the same period of the prior
year. Consumables and GeneKits accounted for 14% of total sales for the nine
months ended September 30, 1998, compared to approximately 10% of total sales in
the same period of the prior year.
Cost of sales increased to $4.4 million for the nine months ended
September 30, 1998 from $1.3 million in the same period of the prior year. In
the nine months ended September 30, 1998, cost of sales aggregated 64.8% of
sales, an improvement compared to 73.6% of sales in the same period of the prior
year. This reflected improved manufacturing processes as production of
sequencers and cassettes was increased during the year.
Sales, general and administrative expense increased to $7.7 million for
the nine months ended September 30, 1998, compared with $4.9 million for the
same period of the prior year, an increase of 57%. The increase resulted
primarily from increased payroll and personnel costs as we hired additional
selling, marketing, administrative and management personnel due to the growth of
our business, established quality control and regulatory departments and the
costs of developing a sales force in North America and Europe. Sales and
marketing expense included in sales, general and administrative expense
increased to $3.5 million for the nine months ended September 30, 1998, compared
with $2.3 million for the same period of the prior year, an increase of 52%.
Research and development expenses increased to $4.3 million for the
nine months ended September 30, 1998, compared with $2.9 million for the same
period of the prior year, an increase of 48%. The increase resulted from
increased payroll and personnel costs along with increased purchases of
laboratory supplies as we developed GeneKits and continued our research
programs.
Acquired research and development expenses relates to a one time charge
of $0.7 million which was recorded during the nine months ended September 30,
1998 to reflect the write-off of research and development acquired upon the
acquisition of ACT Gene S.A., as required under generally accepted accounting
principles.
Interest income declined to $0.2 million for the nine months ended
September 30, 1998,
27
<PAGE>
compared with $0.6 million for the same period of the prior year. Interest
income resulted from interest earned on cash, cash equivalents, and marketable
securities derived from our initial public offering in June, 1996 and a
subsequent term loan agreement in April, 1998. Interest and financing expense
increased to $0.4 million for the nine months ended September 30, 1998, compared
with nil for the same period of the prior year due to interest and financing
costs on the term loan agreement of April 1998.
Liquidity and Capital Resources
Since inception, we have financed operations primarily through private
placements of equity securities, with aggregate proceeds of approximately $17.4
million (including the recent private placement described below), and an initial
public offering in June, 1996, that raised approximately $25.8 million net of
expenses of issue. In April 1998, a term loan facility for $7.0 million was
arranged, which was extended in September 1998 to up to $10.0 million.
Recent Private Placement. On November 20, 1998, we completed a
private offering of 1,528,989 Common Shares. The Company received net proceeds
of approximately $14.1 million, after fees to the placement agent and other
expenses of the offering
Debt Financing. In 1995 and 1996, we secured various additional sources
of temporary financing which were repaid or cancelled following the initial
public offering. In 1997, we secured a bank line of credit for up to $1.1
million with the Royal Bank of Canada. This line was undrawn as at December 31,
1997 and at April 30, 1998 the outstanding balance was approximately $0.4
million. Interest accrued on outstanding balances at the prime rate and was
payable monthly. The bank loan was secured by a lien on our accounts receivable,
inventory and fixed assets. Following negotiation of the term loan agreement,
the bank line was repaid and the line was cancelled.
On April 30, 1998, our subsidiary, VGC entered into a term loan
agreement with the Lenders pursuant to which the Lenders loaned VGC $7.0
million. Proceeds of the loan may be used by VGC, VGI and VGI's other direct or
indirect subsidiaries. The loan bears interest at 10% per annum and interest and
principal are payable in full on April 29, 1999. The loan is guaranteed by VGI,
and VGI's guarantee is secured by a security interest in substantially all the
assets of VGI, including the stock of VGC. The loan and guarantee impose certain
restrictive covenants on VGI and VGC, including a limit on the total
indebtedness which VGI and VGC may incur. In connection with the loan, VGI
issued warrants to the Lenders to purchase an aggregate of 420,000 Common Shares
at an exercise price of $10.00 per share. The warrants are exercisable through
April 30, 2003. On September 28, 1998, the term loan agreement was extended on
similar terms for up to an additional $3.0 million. We have elected to borrow
only an additional $1.0 million under the extended loan facility. This loan is
repayable on December 28, 1999. As a condition to the loan, we issued to the
lenders warrants to purchase 120,000 Common Shares at an exercise price of
$10.00 per share. We are not entitled to borrow any additional funds under the
expanded loan facility.
28
<PAGE>
Capital Expenditures. Additions to fixed assets were approximately $2.7
million, $1.1 million and $0.8 million for the nine months ended September 30,
1998 and for the years ended December 31, 1997 and 1996 respectively. We expect
capital expenditures to increase over the next several years as we expand our
facilities and acquire additional manufacturing equipment and scientific
equipment.
Need for Additional Financing. We have incurred negative cash flow from
operations since inception, and have expended, and expect to continue to expend
in the future, substantial funds to complete our planned product development
efforts, expand our sales and marketing activities and scale up our
manufacturing. At this time, funds from operations are not sufficient to meet
our anticipated financial requirements. Based on current plans, we believe that
current cash balances and anticipated funds from operations will be sufficient
to meet our operating needs (excluding repayment of certain indebtedness) for
approximately the next 12 to 18 months. In addition, on April 29, 1999, we must
repay a $7.7 million (comprising principal and interest) term loan. While we may
be able to repay that loan from our cash balances and anticipated funds from
operations, we cannot be certain at this time that we will be able to do so.
Furthermore, the actual amount of funds that we will need during the next 18
months will be determined by many factors, some of which are beyond our control,
and we may need funds sooner than currently anticipated. These factors include
our success in selling our products during this period, our progress with
research and development, our success in introducing new products during the
period, the costs and timing of obtaining new patent rights, competition and
technological developments in the market.
We anticipate that we will need to obtain additional funds during or at
the end of this 12 to 18 month period. We may also require additional funds to
repay all or a portion of our loan on April 29, 1999. If necessary, potential
sources of additional funding include strategic relationships, refinancing of
the term loan, public or private sales of our shares or debt, or other
arrangements. We do not have any committed sources of additional financing at
this time and it is uncertain whether additional funding will be available when
needed on acceptable terms to or at all. If we raise funds by selling additional
shares, the ownership interest of our existing shareholders will be diluted. If
we are unable to obtain financing when needed, our business and future prospects
would be materially adversely affected. See "Risk Factors - Need for Future
Capital and Uncertainty of Additional Financing."
Year 2000
As the year 2000 approaches, an issue exists for companies that rely on
computers as a result of the computer industry's past practice of using two
digits rather than four digits to identify the applicable year. Consequently,
many software applications and programs may not properly recognize calendar
dates beginning in the year 2000. If not corrected, these applications and
programs could fail or create erroneous results.
We have conducted a comprehensive examination of our information
technology systems, software applications and software applications sold with
our products to determine year 2000
29
<PAGE>
compliance. Based on our examination, we believe that these systems and software
applications are year 2000 compliant.
We recently began the process of reviewing our communications systems
and other non-information technology systems to ascertain whether they are year
2000 compliant. We expect to complete this review by April 30, 1999.
We do not expect that the costs associated with achieving year 2000
compliance will have a material adverse effect on our future results of
operations, liquidity or capital resources. We estimate that the cost of our
year 2000 compliance efforts will be approximately $470,000, of which $450,000
represents the cost of a new enterprise system purchased in 1998. While we did
not purchase the new system specifically in response to year 2000 issues, our
compliance efforts accelerated the timetable for replacing the system. We
believe that the costs to be incurred in reviewing our non-information
technology systems will not be significant.
We have begun contacting our significant customers, suppliers and
third-party service providers to identify year 2000 problems and provide
solutions to prevent the disruption of our business activities. At present, we
have very little information regarding the extent of year 2000 compliance by our
customers, suppliers and third-party service providers. We expect to complete
our review of the compliance efforts by these parties in June 30, 1999.
Until we gain a better understanding of the readiness and plans of its
third-party customers, suppliers and service providers, we will not have a basis
for determining, or developing a response to, a worst case scenario which might
result from their failure to be year 2000 compliant. At present, our management
anticipates that a likely worst case scenario would involve disruption of
significant supply and distribution channels, and in particular the supply of
certain instrument parts and supplies from single-source suppliers. See "Risk
Factors -- Dependence on Third Parties for Supplies; Limited Supply of Certain
Dyes and Parts." This would likely lead to material interruption in product
development and sales of our products. When we complete our review of
significant third party suppliers and customers, we will assess worst case
scenarios and, if necessary, develop one or more contingency plans, such as
securing alternative vendors.
30
<PAGE>
SELLING SHAREHOLDERS
The following table provides certain information with respect to the
Shares issuable upon exercise of the warrants held by each Selling Shareholder
as of November 25, 1998. The Selling Shareholders acquired their warrants in
connection with loans which they made to us in March 1996. The Selling
Shareholders loaned us an aggregate of $1.2 million and received an aggregate of
76,734 warrants. The loans were repaid in June 1996 from the proceeds of our
initial public offering. We granted the warrantholders certain registration
rights, pursuant to which the Shares issuable upon exercise of their warrants
are now being registered.
Except as described above or otherwise noted in the footnotes following
the table, none of the Selling Shareholders has held any position or office, or
has had a material relationship with our Company or our subsidiaries or other
affiliates within the past three years, other than owning Common Shares. Except
as otherwise noted, all of the Common Shares issuable upon exercise of the
warrants owned by each Selling Shareholder are registered for sale pursuant to
this Prospectus. The Selling Shareholders, however, are not under any obligation
to exercise their warrants or sell all or any portion of their Shares, nor are
the Selling Shareholders obligated to sell any of their Shares immediately under
this Prospectus. We will not receive any proceeds from any sales of Shares by
the Selling Shareholders.
<TABLE>
<CAPTION>
Number of Number of
Common Common Shares CommonnShares
Selling Shares Owned Offered Pursuant Owned After
Shareholder Before Offering(1) to this Prospectus(2) Offering(3)
- --------------- ------------------ --------------------- --------------
<S> <C> <C> <C>
Jorge Bernhard(4) 15,347 15,347 0
Karle Ltd. 27,624 27,624 0
John F. McIlwain 3,069 3,069 0
Privatech Investments Inc. 15,347 15,347 0
Daniel H. Renberg Living Trust 25,347 15,347 10,000
</TABLE>
- --------------
(1) Includes shares issuable upon exercise of warrants.
(2) Assumes the exercise of all warrants and options at exercise prices in
effect on November 30, 1998.
(3) Assuming all of the Shares offered by each Selling Shareholder are sold in
the Offering.
(4) Mr. Bernhard served as a director of the Company from May 14, 1997 to
August 30, 1997.
31
<PAGE>
PLAN OF DISTRIBUTION
The Common Shares may be sold from time to time by the selling
shareholders in one or more transactions at fixed prices, at market prices at
the time of sale, at varying prices determined at the time of sale or at
negotiated prices. The selling shareholders may offer their Common Shares in one
or more of the following transactions:
- on any national securities exchange or quotation service on
which the Common Shares may be listed or quoted at the time of
sale, including the Nasdaq National Market;
- in the over-the-counter market;
- in private transactions;
- through options;
- by pledge to secure debts and other obligations;
- or a combination of any of the above transactions
If required, we will distribute a supplement to this Prospectus to
describe material changes in the terms of the offering by the selling
shareholders.
The Common Shares described in this Prospectus may be sold from time to
time directly by the selling shareholders. Alternatively, the selling
shareholders may from time to time offer Common Shares to or through
underwriters, broker/dealers or agents. The selling shareholders and any
underwriters, broker/dealers or agents that participate in the distribution of
the Common Shares may be deemed to be "underwriters" within the meaning of the
Securities Act of 1933. Any profits on the resale of Common Shares and any
compensation received by any underwriter, broker/dealer or agent may be deemed
to be underwriting discounts and commissions under the Securities Act of 1933.
Any shares covered by this Prospectus which qualify for sale pursuant
to Rule 144 under the Securities Act of 1933 may be sold under Rule 144 rather
than pursuant to this Prospectus. The selling shareholders may not be able to
sell all of their shares under Rule 144. The selling shareholders may transfer,
devise or gift such shares by other means not described in this Prospectus.
To comply with the securities laws of certain jurisdictions, the Common
Shares must be offered or sold only through registered or licensed brokers or
dealers. In addition, in certain jurisdictions, the Common Shares may not be
offered or sold unless they have been registered or qualified for sale or an
exemption is available and complied with.
32
<PAGE>
The anti-manipulation provisions of Rules 101 through 104 under
Regulation M of the Exchange Act may apply to purchases and sales of Common
Shares by the Selling Shareholders. In addition, there are restrictions on
market-making activities by persons engaged in the distribution of the Common
Shares.
We have agreed to pay all of the expenses relating to the registration,
offering and sale of the Shares by the Selling Shareholder to the public, other
than commissions or discounts of underwriters, broker-dealers or agents. We
estimate that our expenses in connection with the Offering will be approximately
$10,000.
33
<PAGE>
DESCRIPTION OF CAPITAL SHARES
General
The current authorized capital of our company consists of an unlimited
number of Common Shares and an unlimited number of preferred shares. Any series
of Preferred Shares which our Board of Directors may issue could have rights
equal or superior to the rights of the Common Shares.
Common Shares
The holders of Common Shares are entitled to receive dividends if, as
and when declared by our Board of Directors, subject to the rights of the
holders of any other class of our shares entitled to receive dividends in
priority to the Common Shares. Some of our loan agreements restrict our rights
to pay dividends to the holders of the Common Shares and give our lenders
priority over the rights of the shareholders in the event our company were to be
liquidated or dissolved. If our company were liquidated or dissolved, the
holders of Common Shares would be entitled to receive all assets remaining after
the rights of the holders of any other class of shares entitled to receive
assets in priority to the holders of the Common Shares have been satisfied.
The holders of the Common Shares are entitled to one vote for each
Common Share held at all meetings of our shareholders.
Preferred Shares
Our Board of Directors is authorized to issue an unlimited number of
preferred shares in one or more series, to fix the number of preferred shares
and determine the designations, rights (including voting and dividend rights),
privileges, restrictions and conditions attaching to the shares of each such
series, without further vote or action by the shareholders. Because the terms of
the preferred shares may be fixed by our Board of Directors without shareholder
action, the preferred shares could, subject to regulatory policies, be issued
quickly, with terms calculated to defeat a takeover of our company or to make
the removal of our directors and executive officers more difficult. Under
certain circumstances, this could have the effect of decreasing the market value
of the Common Shares. The preferred shares may have voting rights superior to
the Common Shares and may rank senior to the Common Shares as to dividends and
as to the distribution of assets in the event our company were liquidated or
dissolved. We have no present plans to issue any series of preferred shares. See
"Risk Factors -- Our Unlimited Preferred Shares and Classified Board of
Directors Could Prohibit Takeovers."
Transfer Agent
The transfer agent and registrar for our Common Shares is ChaseMellon
Shareholder Services, L.L.C., 450 West 33rd Street, 15th Floor, New York, New
York 10001-2697.
34
<PAGE>
LEGAL MATTERS
The validity of the Shares being offered hereby has been passed upon
for us by our attorneys, Goldman, Spring, Schwartz & Kichler, 40 Sheppard Avenue
West, Suite 700, North York, Ontario, Canada M2N 6K9. Certain other matters
relating to this offering with respect to United States securities laws will be
passed upon by our attorneys, Baer Marks & Upham LLP, 805 Third Avenue, New
York, New York 10022. Certain matters relating to regulation by the U.S. Food
and Drug Administration will be passed upon by our attorneys, Hyman, Phelps &
McNamara, P.C., 700 13th Street, NW, Washington, D.C. 20005. Samuel Schwartz, a
senior partner of Goldman, Spring, Schwartz & Kichler, is a director of the
Company. Mr. Schwartz holds options to purchase an aggregate of 85,040 Common
Shares at various exercise prices.
EXPERTS
Our annual consolidated financial statements incorporated in this
Prospectus by reference to our Annual Report, have been so incorporated in
reliance on the report of PricewaterhouseCoopers LLP, chartered accountants,
given on the authority of said firm as expert in auditing and accounting.
ADDITIONAL INFORMATION
We have filed with the Commission a Registration Statement on Form F-3
(the "Registration Statement") under the Securities Act, with respect to the
Shares offered hereby. This Prospectus, which constitutes a part of the
Registration Statement, does not contain all of the information set forth in the
Registration Statement. Certain items of the Registration Statement are
contained in exhibits and schedules as permitted by the rules and regulations of
the Commission. Statements made in this Prospectus as to the contents of any
contract, agreement or other document referred to are not necessarily complete;
with respect to each such contract, agreement or other document filed as an
exhibit to the Registration Statement, reference is made to the exhibit for a
more complete description of the matter involved, and each such statement shall
be deemed qualified in its entirety by such reference.
35
<PAGE>
VISIBLE GENETICS INC.
76,734 Common Shares
---------------------------------
Selling Shareholders' Prospectus
---------------------------------
December __, 1998
No dealer, salesman or other person has been authorized in connection with this
Offering to give any information or to make any representation other than those
contained in this Prospectus, and, if given or made, such information or
representation must not be relied upon as having been authorized by us or any
broker, dealer, agent or underwriter. This Prospectus does not constitute an
offer to sell or a solicitation of an offer to buy any of these securities in
any jurisdiction to any person to whom it is unlawful to make such offer or
solicitation. Except where otherwise indicated, this Prospectus speaks as of the
effective date of the Registration Statement. Neither the delivery of this
Prospectus nor any sale hereunder shall under any circumstances create any
implication that there have been no changes in our affairs since the date of
this Prospectus.
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The following table sets forth the estimated expenses of the
Company in connection with the offering described in this Registration
Statement. All of these expenses are being borne by the Company.
<TABLE>
<S> <C>
Securities and Exchange Commission filing fee............................................ $ 225.33
Accounting fees.......................................................................... 1,000.00
Legal fees............................................................................... 5,000.00
Printing and engraving................................................................... 2,500.00
Miscellaneous............................................................................ 1,274.67
Total................................................................................ $ 10,000.00
------------
------------
</TABLE>
Item 15. Indemnification of Directors and Officers.
Section 136 of the Ontario Business Corporations Act and Section 7 of
the Company's By-Laws Nos. 1 and 2 provide for the indemnification of directors
and officers of the Company. Under these provisions, the Company shall indemnify
a director or officer of the Company (or a former director or officer) against
all costs, charges and expenses, including amounts paid to settle an action or
satisfy a judgment, reasonably incurred by such director or officer in respect
of any civil, criminal or administrative action or proceeding (other than in
respect of an action by or on behalf of the Company to procure a judgment in its
favor) to which such director or officer (or a former director or officer) is
made a party by reason of his or her position with the Company, provided such
director or officer: (a) acted honestly and in good faith with a view to the
best interests of the Company and (b) in the case of a criminal or
administrative action or proceeding that is enforced by a monetary penalty, had
reasonable grounds for believing that his conduct was lawful. In respect of an
action by or on behalf of the Company to procure a judgment in its favor, the
Company, with the approval of a court, may indemnify a director or officer of
the Company (or a former director or officer) against all costs, charges and
expenses reasonably incurred by him in connection with such action if he
fulfills the conditions set out in clauses (a) and (b) of the previous sentence.
Notwithstanding the foregoing, a director or officer of the Company (or a former
director or officer) is entitled to indemnification from the Company with
respect to all costs, charges and expenses reasonably incurred by him in
connection with the defense of any civil, criminal or administrative action or
proceeding to which he is made a party by reason of his position with the
Company if he was substantially successful on the merits in his defense of the
action or proceeding and he fulfills the conditions in clauses (a) and (b) of
the second sentence of this paragraph.
II-1
<PAGE>
The Company also has a policy insuring it and its directors and
officers against certain liabilities and has entered into indemnification
agreements with each of its directors and officers.
Item 16. Exhibits
The following exhibits are being filed herewith:
Exhibits
3.1 Amended Articles of Incorporation of the Company.(1)
3.2 Amended and Restated Bylaws of the Company.(2)
4.1 Specimen of Certificate for Common Shares.(3)
5.1 Opinion of Goldman, Spring, Schwartz & Kichler as to the
legality of the Common Shares
23.1 Consent of Goldman, Spring, Schwartz & Kichler (included
in Exhibit 5.1)
23.2 Consent of Baer Marks & Upham LLP
23.3 Consent of PricewaterhouseCoopers LLP
23.4 Consent of Hyman, Phelps & McNamara, P.C.
24 Powers of Attorney (included on the executed signature
page of this Registration Statement)
- ------------------
(1) Incorporated by reference from Exhibit 3.1 to Amendment No. 1 to the
Company's Registration Statement on Form F-1, File No. 333-3118 filed with
the Securities and Exchange Commission on May 15, 1996.
(2) Incorporated by reference from Exhibit 3.2 to Amendment No. 1 to the
Company's Registration Statement on Form F-1, File No. 333-3118 filed with
the Securities and Exchange Commission on May 15, 1996.
(3) Incorporated by reference from Exhibit 4.1 to Amendment No. 1 to the
Company's Registration Statement on Form F-1, File No. 333-3118 filed with
the Securities and Exchange Commission on May 15, 1996.
Item 17. Undertakings
The undersigned Registrant hereby undertakes as follows:
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this
Registration Statement.
II-2
<PAGE>
(i) To include any Prospectus required by Section 10(a)
(3) of the Securities Act of 1933;
(ii) To reflect in the Prospectus any facts or events
arising after the effective date of the Registration
Statement (or the most recent post-effective
amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the
information set forth in the Registration Statement;
and
(iii) To include any material information with respect to
the plan of distribution not previously disclosed in
the Registration Statement or any material change to
such information in the Registration Statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment
shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona
fide offering thereof.
(3) To remove from registration by means of a post-effective
amendment any of the securities being registered which remains
unsold at the termination of the offering.
(4) To file a post-effective amendment to the Registration
Statement to include any financial statements required by Rule
3-19 of Regulation S-X at the start of any delayed offering or
throughout a continuous offering.
The undersigned registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan's annual report pursuant to Section 15(d) of the Securities Exchange Act of
1934) that is incorporated by reference in the Registration Statement shall be
deemed to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed to be
in the initial bona fide offering thereof.
Insofar as indemnification for liabilities arising under the Securities
Act of 1933 may be permitted to directors, officers and controlling persons of
the registrant pursuant to the foregoing provisions, or otherwise, the
registrant has been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification
against such liabilities (other than the payment by the registrant of expenses
incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification
II-3
<PAGE>
by it is against public policy as expressed in the Act and will be governed by
the final adjudication of such issue.
The undersigned registrant hereby undertakes to deliver or cause to be
delivered with the Prospectus, to each person to whom the Prospectus is sent or
given, the latest annual report, to security holders that is incorporated by
reference in the prospectus and furnished pursuant to and meeting the
requirements of Rule 14a-3 or Rule 14c-3 under the Securities Exchange Act of
1934; and, where interim financial information required to be presented by
Article 3 of Regulation S-X is not set forth in the prospectus, to deliver, or
cause to be delivered to each person to whom the prospectus is sent or given,
the latest quarterly report that is specifically incorporated by reference in
the prospectus to provide such interim financial information.
The undersigned registrant hereby undertakes to deliver or cause to be
delivered with the prospectus, to each person to which the prospectus is sent or
given, the registrant's latest filing on Form 20-F.
II-4
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the
Registrant certifies that it has reasonable grounds to believe that it meets all
of the requirements for filing on Form F-3 and has duly caused this Registration
Statement or amendment to be signed on its behalf by the undersigned, thereunto
duly authorized in the City of Toronto, Province of Ontario, Canada on the 15th
day of December, 1998.
VISIBLE GENETICS INC.
By: /s/ Dr. John K. Stevens
---------------------------------------
Dr. John K. Stevens, Chairman of the
Board of Directors, President and Chief
Executive Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each director and officer whose
signature appears below constitutes and appoints Dr. John K. Stevens, Jeffrey D.
Sherman and Samuel Schwartz, or any of them, as his true and lawful
attorneys-in-fact and agents, with full powers of substitution and
re-substitution, for him and in his name, place and stead, to sign in any and
all capacities any and all amendments (including post-effective amendments) to
this Registration Statement on Form F-3 and to file the same, with all exhibits
thereto and all other documents in connection therewith, with the Securities and
Exchange Commission, granting unto said attorneys-in-fact and agents, and each
of them, full power and authority to do and perform each and every act and thing
requisite and necessary to be done, as fully to all intents and purposes as he
might or could do in person, hereby ratifying and confirming all that such
attorneys-in-fact and agents, or any of them, may lawfully do or cause to be
done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this
Registration Statement has been signed by the following persons in the
capacities and on the dates indicated.
<PAGE>
<TABLE>
<CAPTION>
Signature Title Date
------------- ------- -------
<S> <C> <C>
/s/ Dr. John K. Stevens Chairman of the Board, President December 15, 1998
- ------------------------------------------- and Chief Executive Officer
Dr. John K. Stevens (principal executive officer)
/s/ Jeffrey D. Sherman Vice President-- Finance and Chief December 15, 1998
- ------------------------------------------- Financial Officer (principal
Jeffrey D. Sherman financial officer and principal
accounting officer)
/s/ Samuel Schwartz Director December 15, 1998
- -------------------------------------------
Samuel Schwartz
/s/ Richard T. Daly Director December 15, 1998
- -------------------------------------------
Richard T. Daly
/s/ David Dvorchik Director December 15, 1998
- -------------------------------------------
David Dvorchik
/s/ Sheldon Inwentash Director December 15, 1998
- -------------------------------------------
Sheldon Inwentash
/s/ Dr. Lloyd M. Smith Director December 15, 1998
- -------------------------------------------
Dr. Lloyd M. Smith
/s/ Dr. Konrad M. Weiss Director December 15, 1998
- -------------------------------------------
Dr. Konrad M. Weiss
<PAGE>
Authorized Representative
in the United States:
BAER MARKS & UPHAM LLP December 15, 1998
/s/ Steven S. Pretsfelder, Esq.
- -------------------------------------------
Steven S. Pretsfelder, Esq.
</TABLE>
<PAGE>
Exhibit 5.1
December 15, 1998
Visible Genetics Inc.
Suite 1000, Box 333
700 Bay Street
Toronto, Ontario
Canada M5G 1Z6
Gentlemen:
RE: Visible Genetics Inc.
Registration Statement on Form F-3
We have acted as Canadian counsel to Visible Genetics Inc. (the
"Company") in connection with the preparation and filing with the Securities and
Exchange Commission of the Company's Registration Statement on Form F-3 (the
"Registration Statement") under the Securities Act of 1933, as amended (the
"Securities Act") relating to the registration of (the "Offering") 76,734 common
shares (the "Common Shares"), to be sold by the Selling Shareholders.
Capitalized terms used herein but not otherwise defined shall have the
respective meanings set forth in the Registration Statement.
In connection with the foregoing, we have examined copies of the
Company's Amended and Restated Articles of Incorporation (the "Restated Articles
of Incorporation") and the Amended and Restated by-laws, the Registration
Statement and all exhibits thereto, the minutes of various meetings or unanimous
written consents of the Board of Directors of the Company, and originals,
photocopies or certified copies of all such records of the Company, and all such
agreements,
<PAGE>
certificates of public officials, certificates of officers and
representatives of the Company and others, and such other documents, papers,
statutes and authorities, as we deemed necessary to form the basis of the
opinion hereinafter expressed. In such examination, we have assumed the
genuineness of all signatures, the authenticity and accuracy of all documents
submitted to us as originals and the conformity to original documents of all
documents supplied to us as copies. As to various questions of fact material to
such opinion, we have relied upon statements and certificates of officers of the
Company and others.
Based upon the foregoing and subject to the qualifications and
limitations stated herein, we are of the opinion that the Common Shares, when
sold by the Selling Shareholders, will be validly issued, fully paid and
non-assessable.
We hereby consent to the use of this opinion as an exhibit to the
Registration Statement and to the use of our name under the captions "Service
and Enforcement of Legal Process" and "Legal Matters" in the Prospectus forming
a part of the Registration Statement. We hereby also consent to the
incorporation by reference of this consent into a subsequent registration
statement filed by the Company pursuant to Rule 462(b) under the Securities Act
relating to the offering covered by the Registration Statement. In giving such
consent, we do not thereby concede that we are in the category of persons whose
consent is required under Section 7 of the Securities Act or the rules and
regulations promulgated thereunder, or that we are "experts" within the meaning
of the Securities Act or the rules and regulations promulgated thereunder.
Yours very truly
/s/ GOLDMAN, SPRING, SCHWARTZ & KICHLER
<PAGE>
Exhibit 23.2
We hereby consent to the use of our name under the caption "Legal
Matters" in the prospectus forming a part of this Registration Statement on Form
F-3 of Visible Genetics Inc. In giving such consent, we do not thereby concede
that we are in the category of persons whose consent is required under Section 7
of the Securities Act of 1933 as amended (the "Act"), or the rules and
regulations thereunder, or that we are "experts" within the meaning of the Act
or such rules and regulations.
Dated: December 15, 1998
Very truly yours,
/s/ Baer Marks & Upham LLP
<PAGE>
Exhibit 23.3
PRICEWATERHOUSECOOPERS
- ------------------------------------------ -------------------------------------
PricewaterhouseCoopers LLP
Chartered Accountants
5700 Yonge Street
Suite 1900
December 14, 1998 North York Ontario
Canada M2M 4K7
Telephone +1 (416) 218 1500
Facsimile +1 (416) 218-1499
Direct Tel. +1 (416) 218-1432
Direct Fax +1 (416) 218-1499
Consent of Independent Public Accountants
We hereby consent to the incorporation by reference in the Registration
Statement on Form F-3 of Visible Genetics Inc. (the "Company"), of our report
dated February 20, 1998 relating to our audit of the Company's consolidated
balance sheets as at December 31, 1997 and 1996 and the consolidated statements
of operations and deficit and consolidated changes in cash flows for the years
ended December 31, 1997, 1996 and 1995, which report is included in the
Company's Annual Report on Form 20-F dated May 8, 1998, and to the reference in
the Registration Statement to our firm under the heading "Experts."
/s/ PricewaterhouseCoopers LLP
- ------------------------------------
Chartered Accountants
PricewaterhouseCoopers LLP is a Canadian member form of PricewaterhouseCoopers
International, an English company limited by guarantee.
<PAGE>
Exhibit 23.4
We hereby consent to the use of our name under the caption "Legal
Matters" in the prospectus forming a part of this Registration Statement on Form
F-3 of Visible Genetics Inc. In giving such consent, we do not thereby concede
that we are in the category of persons whose consent is required under Section 7
of the Securities Act of 1933, as amended (the "Act"), or the rules and
regulations thereunder, or that we are "experts" within the meaning of the Act
or such rules and regulations.
Dated: December 15, 1998
Very truly yours,
/s/ Hyman, Phelps & McNamara, P.C.
