AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 17, 1999
COMMISSION FILE NO. __________
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM F-3
REGISTRATION STATEMENT
Under
THE SECURITIES ACT OF 1933
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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.)
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700 BAY STREET
SUITE 1000
TORONTO, ONTARIO
CANADA M5G 1Z6
(416) 813-3242
(Address and telephone number of Registrant's principal executive offices)
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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:
SAMUEL SCHWARTZ, ESQ.
GOLDMAN, SPRING, SCHWARTZ & KICHLER
STEVEN S. PRETSFELDER, ESQ. 40 SHEPPARD AVENUE WEST
BAER MARKS & UPHAM LLP SUITE 700
805 THIRD AVENUE TORONTO, ONTARIO
NEW YORK, NEW YORK 10022 CANADA M2N 6K9
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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
PROPOSED
TITLE OF EACH CLASS MAXIMUM
OF SECURITIES TO BE AMOUNT TO BE AGGREGATE OFFERING AMOUNT OF
REGISTERED REGISTERED(1) PRICE PER SHARE(2) PRICE REGISTRATION FEE
- --------------------------- --------------------- -------------------- ---------------------- ----------------------
Common Shares.............. 5,283,758 $18.00 $95,107,644 $26,439.93
- --------------------------- --------------------- -------------------- ---------------------- ----------------------
(1) Pursuant to Rule 416, this Registration Statement also covers an
indeterminable number of additional common shares issuable as a result of
any future anti-dilution adjustments.
(2) This amount is based upon the average of the closing bid and asked prices
as of November 16, 1999, 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.
================================================================================
SELLING SHAREHOLDERS'
PROSPECTUS
5,283,758 SHARES
VISIBLE GENETICS INC.
COMMON SHARES
This is an offering of common shares by certain holders of convertible
preferred shares and warrants of Visible Genetics Inc. The common shares covered
by this prospectus will be issued to the warrantholders, and may be sold by
them, upon exercise of their warrants, and will be issued to the holders of
convertible shares, and may be sold by them, upon conversion of their preferred
shares.
The selling shareholders will receive all of the proceeds from the sale
of the common shares, less any commissions or discounts paid to brokers or other
agents. We will not receive any of the proceeds from the sale of the common
shares.
The selling shareholders may offer and sell the common shares on the
Nasdaq National Market at prevailing market prices or in privately negotiated
transactions at prices other than the market price. On November 16, 1999, the
closing sale price for our common shares on the Nasdaq National Market was
$18.125.
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INVESTING IN OUR SHARES INVOLVES A HIGH DEGREE OF
RISK. SEE "RISK FACTORS" BEGINNING ON PAGE 3.
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NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE
ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
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NOVEMBER __, 1999
TABLE OF CONTENTS
PAGE
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE..................................................................1
PROSPECTUS SUMMARY...............................................................................................2
RISK FACTORS.....................................................................................................3
FORWARD-LOOKING STATEMENTS......................................................................................20
USE OF PROCEEDS.................................................................................................23
DIVIDEND POLICY.................................................................................................23
SELECTED CONSOLIDATED FINANCIAL DATA............................................................................24
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS...........................25
INFORMATION ABOUT THE COMPANY...................................................................................32
SELLING SHAREHOLDERS............................................................................................34
PLAN OF DISTRIBUTION............................................................................................36
DESCRIPTION OF CAPITAL SHARES...................................................................................37
LEGAL MATTERS...................................................................................................40
EXPERTS.........................................................................................................40
WHERE YOU CAN FIND MORE INFORMATION.............................................................................40
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents, which we have 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, 1998.
2) Our Report on Form 6-K Filing No. 3 for the Month of July, 1999,
dated July 16, 1999.
3) Our Report on Form 6-K Filing No. 1 for the Month of August 1999,
dated August 6, 1999.
4) Our Report on Form 6-K Filing No. 1 for the Month of November
1999, dated November 10, 1999.
In addition, all documents which we file with the Securities and
Exchange Commission pursuant to Section 13, 14 or 15(d) of the Securities
Exchange Act of 1934, as amended after the date of the this prospectus and
before termination of the offering, 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 us at:
Visible Genetics Inc.
700 Bay Street
Suite 1000
Toronto, Ontario, Canada M5G 1Z6
Attention: Mr. Kingsley Thomas
Or you can call us at (416) 813-3240. See "Where You Can Find More Information."
PROSPECTUS SUMMARY
THIS PROSPECTUS SUMMARY HIGHLIGHTS SELECTED INFORMATION CONTAINED
ELSEWHERE IN THIS PROSPECTUS. YOU SHOULD READ THE FOLLOWING SUMMARY TOGETHER
WITH THE MORE DETAILED INFORMATION REGARDING OUR COMPANY AND THE SHARES BEING
SOLD IN THIS OFFERING, WHICH INFORMATION APPEARS ELSEWHERE IN THIS PROSPECTUS
AND IN SELECTED PORTIONS OF OUR ANNUAL REPORT ON FORM 20-F AND OTHER DOCUMENTS
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION THAT WE HAVE INCORPORATED BY
REFERENCE INTO THIS PROSPECTUS. ALL FINANCIAL INFORMATION PROVIDED IN THIS
PROSPECTUS IS IN U.S. DOLLARS.
OUR BUSINESS
We develop, manufacture and sell integrated DNA sequencing systems that
analyze genetic information to improve the treatment of selected diseases. Our
proprietary DNA sequencing system, called the OpenGene System, is designed to
identify mutations, or changes, in the DNA of genes associated with some
infectious diseases, cancers and other medical conditions. We believe that our
DNA sequencing systems will enable clinicians to monitor and customize the
treatment of diseases, initially for Human Immunodeficiency Virus, or HIV, and
later for other selected diseases.
DNA sequencing is generally considered the most thorough and accurate
method for genotyping diseases, such as cancer and certain viruses, including
HIV, which have high rates of mutation or numerous strains. Genotyping is the
act of selecting and reading certain components of the sequence of a specific
strand of DNA in order to understand how mutations in the DNA may influence the
onset and treatment of some diseases and medical conditions. Most existing DNA
sequencers have been developed to meet the needs of the research market and
typically do not address the needs of the clinical diagnostic market. We have
designed our OpenGene System to meet the needs of the clinical diagnostic
market.
Our OpenGene System consists of automated DNA sequencers, disposable
gel cassettes, related equipment and software and disease-specific GeneKits. Our
GeneKits contain the necessary chemicals, reagents, third-party licenses and
other consumables and materials required for sequencing specific
disease-associated genes. We have developed GeneKits for HIV, HLA (used for
tissue typing, for example, in organ transplants) and the p53 gene (implicated
in many cancers). We are developing GeneKits for hepatitis B, hepatitis C and
tuberculosis. We began selling our OpenGene System to the research and clinical
research markets in the third quarter of 1996 and began selling GeneKits in the
third quarter of 1997. More than 600 of our DNA sequencers are installed in over
150 laboratories.
The first clinical diagnostic application we are targeting is HIV. We
have developed our HIV GeneKit to enable clinicians to genotype the major HIV
species infecting patients in order to improve the management of patient
treatment. HIV is a highly variable virus with high rates of mutations, which
may lead to drug resistance. One of the central challenges in maintaining HIV
patients on long-term drug therapy is to adjust each patient's medication as
drug-resistant strains of the virus emerge. Two initial clinical trials,
including one which we conducted, have shown that patients whose drug therapy is
managed using HIV genotyping had greater reductions in viral load than HIV
patients who were not genotyped.
We plan to apply to the U.S. Food and Drug Administration, or FDA, for
approval to sell our HIV OpenGene System to the clinical diagnostic market. In
December 1998, the FDA allowed us to initiate human clinical trials of our HIV
OpenGene System under an Investigational Device Exemption application, or IDE.
We intend to use the results of our clinical trials, as well as the results of a
clinical trial conducted by others, in support of our proposed FDA application.
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. INFORMATION CONTAINED ON OUR WEBSITE
DOES NOT CONSTITUTE A PART OF THIS PROSPECTUS.
2
RISK FACTORS
YOU SHOULD CAREFULLY CONSIDER THE RISKS AND UNCERTAINTIES DESCRIBED
BELOW BEFORE MAKING AN INVESTMENT DECISION. IF ANY OF THE FOLLOWING RISKS
ACTUALLY OCCUR, OUR BUSINESS, FINANCIAL CONDITION OR OPERATING RESULTS COULD BE
MATERIALLY HARMED. THIS COULD CAUSE THE TRADING PRICE OF OUR COMMON SHARES TO
DECLINE, AND YOU MAY LOSE ALL OR PART OF YOUR INVESTMENT.
THIS PROSPECTUS CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE KNOWN
AND UNKNOWN RISKS AND UNCERTAINTIES. THESE STATEMENTS RELATE TO OUR PLANS,
OBJECTIVES, EXPECTATIONS AND INTENTIONS. OUR ACTUAL RESULTS COULD DIFFER
MATERIALLY FROM THOSE DISCUSSED IN THESE STATEMENTS. FACTORS THAT COULD
CONTRIBUTE TO THESE DIFFERENCES INCLUDE THOSE DISCUSSED BELOW AND ELSEWHERE IN
THIS PROSPECTUS.
WE ARE IN THE EARLY STAGES OF COMMERCIAL MANUFACTURING AND SALE OF OUR PRODUCTS
Although we began operations in 1993, we are only in the early stages
of commercially manufacturing and marketing our products. Until 1996, we devoted
much of our time to the research and development of our technology and products.
In late 1996, we began manufacturing and selling to the research and clinical
research markets, the initial versions of our automated DNA sequencers and
related products and certain GeneKits. Our limited operating history makes it
difficult to evaluate our business and our prospects for future profitability.
Our prospects must be considered in light of the risks, expenses and
difficulties frequently encountered by companies in their early stages of
commercial manufacturing and marketing. Sales for our 1998 fiscal year were
$10.9 million and for the nine months ended September 30, 1999 were $8.7
million. In the future, sales may not increase or they may decrease, and we may
never become profitable.
WE HAVE A HISTORY OF LOSSES AND ANTICIPATE FUTURE LOSSES
We incurred a net loss of $14.9 million in the year ended December 31,
1998 and $18.5 million during the nine months ended September 30, 1999. As of
September 30, 1999, our accumulated deficit was $53.5 million. Our losses have
resulted principally from expenses incurred in research and development of our
technology and products, including clinical trials, and from selling, general
and administrative expenses that we have incurred while building our business
infrastructure and in connection with our operations. We expect to continue to
incur significant operating losses in the future as we continue our research and
development efforts and expand our sales and marketing force and business
infrastructure, in an effort to achieve greater sales and expand our business.
It is uncertain when, if ever, we will become profitable. Our ability to become
profitable will depend on many factors including:
- whether we obtain regulatory approval to sell our HIV OpenGene
System and, in the future, OpenGene Systems for other
diseases, to the clinical diagnostic market in the United
States and abroad;
- if we obtain regulatory approval, the acceptance of our HIV
OpenGene System and, in the future, OpenGene Systems for other
diseases, within the clinical diagnostic market;
- our ability to successfully market and sell our HIV OpenGene
System and, in the future, OpenGene Systems for other
diseases, to the clinical diagnostic market;
- the decision of third party payors to reimburse clinicians and
patients for use of our HIV GeneKit and, in the future, other
products;
- the acceptance of genotyping as a valid method of managing
disease therapy for the diseases and genes we currently target
and intend to target in the future;
- our ability to increase sales of our products to the research
and clinical research markets;
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- our ability to effectively manage the growth of our business;
- our ability to attract and retain qualified personnel;
- our ability to continue to develop advanced versions of our
products and technologies and new products and technologies in
a timely manner; and
- our ability to obtain, and the costs of obtaining, patents and
licenses for certain products and technologies.
OUR RESULTS TEND TO FLUCTUATE FROM QUARTER TO QUARTER
Our operating results have varied on a quarterly basis in the past and
may fluctuate significantly in the future as a result of a variety of factors,
many of which are outside our control. Factors that may affect our quarterly
operating results include:
- the announcement or introduction of new products, services,
technologies or strategic relationships by us or by our
competitors;
- decisions by the FDA and foreign regulatory agencies with
respect to our HIV OpenGene System or other products;
- the acceptance of our HIV OpenGene System and other products
in the clinical diagnostic market, should we obtain required
government authorizations;
- unanticipated costs or delays in carrying out our clinical
trials;
- decisions of third party payors with respect to reimbursement
for our HIV GeneKit and other products;
- the proposal or implementation of regulatory changes in the
United States or abroad that affect our products or our
business;
- the amount and timing of operating costs and capital
expenditures relating to research and development and the
expansion of our business, operations and infrastructure;
- the amount and timing of royalties accrued for licensing of
products and technologies;
- the availability and pricing of raw materials and components
from suppliers;
- our decision to increase or decrease sales of bundled
equipment, GeneKits and other consumables at reduced prices;
- our decision to reduce prices of our products in response to
price reductions by competitors;
- our ability to successfully sell our products;
- the costs associated with, and the success of, any future
acquisitions of businesses, technologies or products, or any
strategic investments or relationships into which we may
enter;
- the cost and timing of obtaining new patent rights or licenses
from third parties;
- our ability to attract and retain personnel; and
- general economic conditions, as well as economic conditions
specific to the biotechnology industry.
Due to these and other factors, our quarterly revenues and operating
results are difficult to forecast. We believe that period-to-period comparisons
of our operating results may not be meaningful and you should not rely on any
such comparisons as an indication of our future performance. In addition, it is
likely that in one or more future quarters our operating results will fall below
the expectations of securities analysts and investors. In such event, the
trading price of our common shares could be materially harmed.
4
WE MAY NOT RECEIVE FDA APPROVAL FOR OUR HIV OPENGENE SYSTEM AND, IN THE FUTURE,
OTHER HIV PRODUCTS
We intend to seek FDA approval to sell our HIV OpenGene System for
clinical diagnostic purposes in the United States. In the future, we may seek
FDA approval to sell other HIV products for clinical diagnostic purposes in the
United States. Under FDA regulations our HIV OpenGene System is currently a
Class III medical device. This means that in order to sell our HIV OpenGene
System in the United States for clinical diagnostic purposes, we will need to
obtain FDA approval. In order to get FDA approval for this device, at the
present time, we must submit a Premarket Approval application, commonly known as
a PMA. To be considered by the FDA, our PMA must be supported by extensive human
clinical data demonstrating the utility, reliability and performance of our HIV
GeneKit and OpenGene System. In December 1998, the FDA allowed us to initiate
human clinical trials of our HIV OpenGene System under our IDE application. We
have conducted one, and are continuing to conduct several additional, clinical
trials, the results of which will be submitted with our PMA application to the
FDA. In addition, for us to obtain FDA approval of our HIV OpenGene System, the
FDA must also confirm that we maintain good laboratory, clinical and
manufacturing practices. We may never obtain approval from the FDA to sell our
HIV products to the clinical diagnostic market. The clinical data from our
trials may not support the utility, reliability or performance of our products,
or our facilities may not be in compliance with the FDA's regulations. In
addition, we may choose or be required to discontinue our trials for a number of
reasons, including unanticipated interim trial reports, changes in regulations
or the adoption of new regulations, or unexpected technological developments by
our competitors. If we fail to receive FDA approval, we will be unable to carry
out our business plan to sell our HIV OpenGene System for clinical diagnostic
use in the United States and our business, financial condition and results of
operations will be materially harmed.
Although our HIV OpenGene System is currently a Class III medical
device, the FDA recently asked an advisory committee of experts whether HIV
genotyping tests should be reclassified from Class III to Class II. The advisory
committee recommended reclassification subject to certain controls including
post-market surveillance of the performance of these products. If the FDA
reclassifies HIV genotyping tests from Class III to Class II, we will be able to
obtain FDA permission to market our HIV OpenGene System by submitting a 510(k)
premarket notification, commonly known as a 510(k), rather than a PMA. A 510(k)
generally contains less data than a PMA and is usually reviewed and approved
more quickly by the FDA than a PMA. While we may be able to obtain FDA approval
more quickly and less expensively if the FDA reclassifies HIV genotyping tests
from Class III to Class II, our competitors will also be able to submit 510(k)s
for their products, which would allow them to market their products sooner than
if they had to submit PMAs. Although it is likely that the FDA will follow the
recommendation of its advisory committee, the FDA is required to issue a
proposed regulation, allow the opportunity for public comment and then publish a
final regulation in order to reclassify HIV genotyping tests.
This process could take several years to complete.
We also may be required to obtain approval from some foreign regulatory
authorities to sell our HIV products to the clinical diagnostic market outside
of the United States. In some cases, we will face an approval process similar to
that required by the FDA. We cannot be certain that we will obtain the necessary
approvals to sell our HIV products to the clinical diagnostic market in these
countries. In some cases, the failure to obtain any of these approvals could
materially harm our business, financial condition and results of operations. See
"-We may not receive regulatory approval for our other products," "-The results
of our proposed HIV clinical trails are uncertain" and "-Certain of our products
are subject to government regulation."
WE MAY NOT RECEIVE REGULATORY APPROVAL FOR OUR OTHER PRODUCTS
In addition to our HIV OpenGene System, we have also developed and are
continuing to develop GeneKits for other clinical diagnostic applications. In
order to sell these GeneKits to the clinical
5
diagnostic market, we may be required to obtain the approval of the FDA and of
foreign regulatory authorities. We may be required to conduct extensive testing
and clinical trials to support the utility, reliability and performance of our
products. We may also be required to show that our testing and manufacturing
facilities comply with applicable practices and standards. The approval process
for each additional GeneKit may be lengthy and costly and we may not be able to
obtain the required approval for each GeneKit in each country in which we desire
to sell to the clinical diagnostic market. Our failure to obtain necessary
approvals to sell our products for clinical diagnostic use in one or more
significant markets could cause material harm to our business, financial
condition and results of operations.
THE RESULTS OF OUR PROPOSED HIV CLINICAL TRIALS ARE UNCERTAIN
To support our application to the FDA, whether we submit a PMA or a
510(k), we will be expected to demonstrate through human clinical trials the
utility, reliability and performance of our HIV OpenGene System. We conducted
one trial in Europe which demonstrated that HIV patients whose drug treatments
were selected using periodic genotyping had lower viral loads than patients
whose drug treatments were selected without the use of genotyping. That trial
corroborated the results of another clinical trial conducted in the United
States in which we did not participate. In June 1999 we commenced two clinical
trials in the United States: one to test the clinical utility of our HIV
OpenGene System and another to test the reliability and performance of our HIV
GeneKits. In November 1999, we launched a 200 patient pilot study in connection
with a third, large-scale cost recovery clinical trial with the goal of
collecting additional HIV genotyping data supporting the clinical utility of
using HIV genotyping.
The results from the clinical trials already completed may not
accurately predict the results that will be obtained from the clinical trials we
plan to conduct in the future. In addition, there can be no assurance that any
clinical trials we conduct will demonstrate the utility, reliability and
performance of our HIV OpenGene System. If the new trials are unable to
demonstrate the utility, reliability and performance of our HIV OpenGene System,
we may not obtain FDA approval. In that event, our business, financial condition
and results of operations would be materially harmed. A number of companies in
the biotechnology and pharmaceutical industries have suffered significant
setbacks in advanced clinical trials, even after obtaining promising results in
earlier trials.
The completion of clinical trials for our HIV OpenGene System and, in
the future, any clinical trials of our other products, may be terminated or
delayed by many factors and there can be no assurance that delays or
terminations will not occur. For example, the rate of enrollment of patients in
our trials may affect the amount of time it takes to complete our trials.
Enrollment rates may vary throughout the course of a clinical trial and will
depend on a number of factors including: the size of the patient population, the
number of clinical trial sites, the proximity of patients to clinical trial
sites, the eligibility criteria for the trial and the existence of competitive
clinical trials. We cannot control the rate at which patients present themselves
for enrollment, and we cannot guarantee that the rate of patient enrollment will
be consistent with our expectations or be sufficient to enable clinical trials
of our products to be completed in a timely manner. In addition, certain
clinical trials are conducted with patients having the most advanced stages of
disease. During the course of treatment, these patients may die or suffer other
adverse medical effects for reasons that may not be related to the drug
treatment selections. These events could delay our trials, as well as adversely
affect the statistical analysis of clinical trial results. Any significant
delays in, or termination of, clinical trials of any of our products could
materially harm our business, financial condition and results of operations. See
"-We may not receive FDA approval for our HIV OpenGene System and, in the
future, other HIV products," "-We may not receive regulatory approval for our
other products," and "-Certain of our products are subject to government
regulation."
6
EACH TIME WE MAKE ALTERATIONS TO ANY FDA APPROVED PRODUCTS, WE MAY
NEED TO SEEK ADDITIONAL FDA APPROVAL
If we obtain FDA approval of a PMA for our HIV OpenGene System or
any other product, we may need to seek additional FDA approval each time we
make changes to the product specifically approved by the FDA. For example, we
are seeking FDA approval to sell our HIV OpenGene System to the clinical
diagnostic market. Our HIV GeneKit, as submitted to the FDA, contains
specific reagents, dyes, enzymes, chemicals, software and other materials. If
this kit is approved, the FDA would require that we obtain additional
approval for any change to the kit's components that could alter the
performance of the kit, such as changing certain enzymes or reagents. To
obtain additional approval, we may have to conduct additional human clinical
trials to demonstrate that the altered GeneKit will produce at least the same
results as the approved GeneKit. Obtaining additional FDA approval is likely
to be time consuming and costly and we may experience delays in bringing
these upgraded or new products to market.
If the FDA reclassifies HIV genotyping tests from Class III to Class
II, we will be required to obtain prior clearance from the FDA only for those
product changes that could significantly affect safety or effectiveness.
Obtaining additional FDA approval for these changes is likely to be time
consuming and costly and we may experience delays in bringing these upgraded or
new products to market.
THE CLINICAL DIAGNOSTIC MARKET FOR GENOTYPING PRODUCTS IS NEW AND
GENOTYPING MAY NOT BECOME AN ACCEPTED METHOD OF MANAGING DRUG TREATMENT
An important part of our business strategy is our plan to sell our
products to the clinical diagnostic market if we obtain FDA and other required
regulatory approvals. Our ability to do so will depend on the widespread
acceptance and use by doctors and clinicians of genotyping to manage the
treatment of certain diseases. The use of genotyping by doctors and clinicians
for this purpose is new. Existing DNA sequencing systems have been designed
primarily for research purposes and we are not aware of any DNA sequencing
products that have been approved by the FDA for clinical diagnostic purposes.
The demand for, and acceptance by doctors and clinicians of, DNA sequencing
systems designed for the clinical diagnostic market, such as our HIV OpenGene
System, is uncertain. Factors that may influence the acceptance of genotyping by
this market include the availability of FDA approved genotyping products and the
willingness of insurance companies and other third-party payors to reimburse
doctors and patients for use of these products. If genotyping is not accepted by
this market, we will not be able to carry out our business plan and our
business, financial condition and results of operations will be materially
harmed.
OUR OPENGENE SYSTEM MAY NOT BE ACCEPTED BY THE CLINICAL DIAGNOSTIC MARKET
Even if genotyping becomes widely accepted in the clinical diagnostic
market, we cannot predict the extent to which doctors and clinicians may be
willing to utilize our OpenGene System to manage drug treatment of selected
diseases or other medical conditions. Factors that will influence the use of our
products in this market include:
- our ability to obtain FDA approval in the United States and
other required regulatory approvals in other countries;
- whether major third-party payors decide to reimburse doctors
and patients for use of our products;
- the outcomes of any current or future clinical trials testing
the utility, reliability and performance of our OpenGene
System in managing drug treatment for selected diseases or
other medical conditions; and
7
- the development of competing technologies and products that
can be used for the same purposes as our products.
If our products are not accepted by the clinical diagnostic market to
manage the treatment of selected diseases and other medical conditions, our
business, financial condition and results of operations will be materially
harmed. See "-We may not receive FDA approval for our HIV OpenGene System and,
in the future, other HIV products," "We may not receive regulatory approval for
our other products," "The results of our proposed HIV clinical trials are
uncertain," "Insurance companies and other third-party payors may not reimburse
doctors and patients for our products" and "Certain of our products are subject
to government regulation."
INSURANCE COMPANIES AND OTHER THIRD-PARTY PAYORS MAY NOT REIMBURSE
DOCTORS AND PATIENTS FOR OUR PRODUCTS
Our ability to sell our HIV GeneKit and other GeneKits to the clinical
diagnostic market will depend partly on the willingness of insurance companies
and other third-party payors to reimburse doctors and patients for use of our
products. If we obtain regulatory approval to sell our products, we will seek
reimbursement from government and private health care insurers (including health
maintenance organizations) and other third-party payors. Physicians'
recommendations to use genotyping, as well as decisions by patients to pursue
genotyping, are likely to be influenced by the availability of reimbursement for
genotyping by insurance companies or other 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
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. We cannot guarantee that insurers and other third-party
payors will elect to provide full or partial reimbursement coverage for our HIV
GeneKit and other GeneKits. If adequate reimbursement coverage is not available
from insurers or other third-party payors, it is uncertain whether patients will
elect to directly pay for genotyping. If insurers or other third-party payors
and patients are unwilling to pay for genotyping, our anticipated revenues would
be substantially reduced, our ability to achieve profitability would be
significantly impaired and our business, financial condition and results of
operations would be materially harmed.
WE DO NOT HAVE ANY MARKETING EXPERIENCE IN THE CLINICAL DIAGNOSTIC
MARKET AND WE RELY ON OTHER COMPANIES TO SELL OUR PRODUCTS IN SOME MARKETS
We have no experience marketing products to the clinical diagnostic
market. If the FDA approves the sale of our HIV OpenGene System and, in the
future, other products, to the clinical diagnostic market in the United States,
we intend to expand our internal sales force. It will take significant time,
money and resources to expand our sales force. We may not be able to hire, train
and retain qualified personnel with experience in the clinical diagnostic
market. We cannot be certain that we will be able to develop the marketing
capabilities necessary to successfully market and sell our products to the
clinical diagnostic market. See "We may not receive FDA approval for our HIV
OpenGene System and, in the future, other HIV products," "We may not receive
regulatory approval for our other products," "The results of our proposed HIV
clinical trials are uncertain," and "Certain of our products are subject to
government regulation."
In selected geographic markets outside North America and certain
European countries, we seek to enter into distribution and marketing
arrangements with leading distributors to sell our products to the research and
clinical diagnostic markets. In March 1999, we entered into a series of
exclusive distribution agreements. We granted Roche Diagnostics S.L. and Roche
Diagnostics K.K. exclusive rights to distribute our
8
OpenGene System and GeneKits to the clinical diagnostic markets in Spain,
Portugal and Japan, respectively. We also granted Organon Teknika International
the exclusive right to distribute our OpenGene System and GeneKits to the
clinical diagnostic market in Brazil. We granted exclusive distribution rights
to Werfen Medical S.A. in Argentina and Diagnostic Technology Pty Ltd. in
Australia and New Zealand. We terminated our initial agreement with Roche
Diagnostics S.L. in September 1999 and subsequently entered into a new agreement
with Roche Diagnostics S.L. for these territories. Under the new agreement,
Roche Diagnostics S.L. will act as our exclusive agent in Spain and Portugal and
will receive a commission based on sales. In November 1999, we granted
Amersham-Pharmacia Biotech K.K. the exclusive right to distribute our products
to the research market in Japan. These agreements expire at various times from
April 2000 through April 2003, and in each case, are subject to renewal. Certain
of the agreements may also be terminated by either party upon specified notice
periods and may require us to make termination payments under certain
circumstances.
Our ability to successfully sell products to the clinical diagnostic
market in countries in which we rely on distribution agreements will depend to a
great extent on the efforts of the distributors. Should these distributors be
unwilling to sell our products or if they are unsuccessful in their efforts, our
ability to sell to these markets will be adversely affected. Failure to
successfully market our products will likely impede our ability to generate
significant revenues and become profitable.
In addition, any of our distribution agreements may be terminated
before they expire, or, when they expire, they may not be renewed on favorable
terms or at all. If these agreements are discontinued, our business, financial
condition and results of operations may be materially harmed if we could not
find other suitable distributors to sell these products. See "Certain supplies
and parts that we need are available from limited sources."
WE HAVE LIMITED MARKETING EXPERIENCE IN THE RESEARCH AND CLINICAL
RESEARCH MARKETS AND WE RELY ON AMERSHAM
We have limited experience in marketing products to the research and
clinical research markets. We have developed our own sales and marketing
staff and infrastructure which sells our products in North America and
certain countries in Europe. We have only been engaged in marketing our
products since late 1996. It is uncertain whether our sales and marketing
staff will be able to achieve our sales objectives in a timely and
cost-effective manner. In February 1996, we granted Amersham International
plc an exclusive worldwide license to use and sell the Seq4x4(TM) DNA
sequencer and related products used and sold with the sequencer, which is
designed for the research market. Our agreement with Amersham expires in
February 2000 and is renewable each year unless either party notifies the
other at least six months in advance of renewal that it wishes to terminate
the agreement. During 1998, approximately 30% of our revenues resulted from
sales of sequencers and other products to Amersham, and during the nine
months ended September 30, 1999, 15.6% of our sales resulted from sales to
Amersham. We anticipate that for the remainder of 1999 sales to Amersham will
continue to be significant. We cannot be certain that Amersham will be
successful in selling these products. In addition, we cannot be certain that
the agreement will not be terminated before expiration or that, upon
expiration, it will be renewed on favorable terms or at all.
WE NEED TO CONTINUE DEVELOPING ADVANCED TECHNOLOGY AND VERSIONS OF OUR
PRODUCTS AND NEW PRODUCTS
We believe that if we are to become and remain profitable, we must
develop advanced technology, advanced versions of our current products and new
products. New technology and products 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 technology or products, or that any new
technology or products will achieve acceptance in the market. It is also
possible that we will not have sufficient financing to develop
9
new technology or products. If we are unable to successfully develop technology
or products in the future, our ability to generate significant revenues will be
significantly impaired, we could experience additional significant losses and
our business, financial condition and results of operations would be materially
harmed.
WE HAVE LIMITED MANUFACTURING EXPERIENCE
We have limited experience in large-scale assembly and manufacturing of
our products. We assemble our DNA sequencers, certain related equipment, and our
GeneKits. We also manufacture our MicroCel cassettes, certain of the components
included in our GeneKits and other products. Since we started assembling and
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, shipping existing products and introducing new products to the
marketplace. These problems could also adversely affect customer satisfaction
and the market acceptance of our products.
WE MAY NOT BE ABLE TO OBTAIN AND PROTECT NECESSARY PATENTS AND PROPRIETARY
RIGHTS
Our success will partly depend on our ability to obtain patents, obtain
licenses from third parties and protect our trade secrets. We own or jointly own
25 U.S. patents. We have an additional 36 U.S. patent applications pending, of
which ten have been allowed. A patent allowance is granted by the U.S. Patent
and Trademark Office if, after examination, it finds the patent application
allowable. After a patent is allowed, generally, the patent is issued as soon as
possible after payment of an issuance fee by the applicant. However, because of
the substantial backlog of patent applications in the U.S. Patent and Trademark
Office, the issuance of the patent is often delayed. Until an allowed patent is
actually issued, the U.S. Patent and Trademark Office may reverse its decision
or delay the issuance of the patent. We also have filed foreign patent
applications presently pending as PCT applications designating intergovernmental
agencies and multiple countries including the European Patent Office, Canada and
Japan. We cannot assure you that our remaining patent applications will result
in patents being issued in the United States or foreign countries. Nor can we
assure you that any technologies or products that we may develop in the future
will be patentable. 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 U.S. Patent and Trademark Office and
the decisions whether to approve or reject 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. Also,
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 harm us. 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,
or if the terms of a license are burdensome to us, our business, financial
condition and results of operations could be materially harmed.
10
To help protect our proprietary rights in unpatented trade secrets, we
require our employees, consultants and advisors to sign 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 limited by, the rights of third parties with whom our employees,
consultants or advisors have prior employment or consulting relationships.
Further, others may independently develop similar proprietary information and
techniques, or otherwise gain access to our trade secrets.
CERTAIN OF OUR PRODUCTS ARE SUBJECT TO GOVERNMENT REGULATION
In the United States, the FDA regulates medical products. Similar
agencies exist in Canada, Japan, European countries and elsewhere.
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
manage the treatment of disease. Second, they can be used in the medical care of
specific patients. In that case, they are called diagnostic medical devices.
We currently sell our products for research and clinical research
purposes. In the future, we intend to sell products for clinical diagnostic
purposes. We do not believe we need authorization from the FDA or health
authorities in foreign countries to sell our products for research purposes, as
long as they are properly labeled. We will, however, need authorization to sell
our products for clinical diagnostic purposes.
To obtain FDA authorization for a new medical device, a company may
have to submit data relating to safety and efficacy based on extensive testing.
This testing, the preparation of necessary applications and the processing of
those applications by the FDA, are expensive and may take several years to
complete. For a more complete description of the FDA approval process, see
"Information about the Company-Regulation by the FDA and Other Government
Agencies--FDA APPROVAL PROCESS."
We cannot assure you that the FDA will approve any of our products for
clinical diagnostic purposes, or do so in a timely manner. 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 us and the FDA about whether the tests are
adequate. Because of these and other uncertainties, you should assume that we
may experience delays in obtaining FDA approval, or that we may not receive FDA
approval to sell our products for clinical diagnostic purposes.
At the present time our HIV GeneKit is, and, in the future, other
GeneKits may, be regulated by the FDA as Class III medical devices. We believe
that our other GeneKits and products will be regulated as either Class II or
Class III medical devices. Since our HIV OpenGene System is currently regulated
as a Class III medical device we must submit a PMA in order to sell our HIV
OpenGene System in the United States for clinical diagnostic purposes. To be
considered by the FDA, our PMA must be supported by extensive human clinical
data. In December 1998, the FDA allowed us to initiate human clinical trials of
our HIV OpenGene System under our IDE application. We have conducted one, and
are continuing to conduct several additional, clinical trials, the results of
which will be submitted with our PMA to the FDA. If the FDA reclassifies HIV
genotyping tests from Class III to Class II, we will be able to submit a 510(k),
rather than a PMA, for our HIV GeneKit and HIV OpenGene System. If, however, the
FDA does not complete the reclassification process within a reasonable time
period, we may still have to submit a PMA to obtain permission to market our HIV
OpenGene System on a timely basis.
We also plan to market products outside the United States, initially in
Canada, Japan and selected countries in Europe. Government authorization
requirements similar to the FDA's exist in some of these and many other foreign
countries. Therefore, for us to get authorization to sell our products for
clinical diagnostic purposes in Canada, Japan, and Europe may also require
lengthy and costly testing procedures.
11
In addition, the regulatory bodies in other countries may be affected or
influenced by significantly different criteria than those used by the FDA. Sale
of our products in these areas may be materially affected by the policies of
these bodies or the domestic politics of the countries involved.
We are or may become subject to various federal, state, foreign,
provincial and local laws and regulations, covering a broad range of topics
including:
- worker compensation;
- safe working conditions;
- laboratory and manufacturing practices; - use and disposal of
hazardous chemicals or infectious disease agents and toxic
chemicals; and
- product emissions.
In addition, our reference laboratory in Norcross, Georgia, is subject
to regulation under the Clinical Laboratory Improvement Amendments of 1988,
known as CLIA. Under CLIA, laboratories must meet various requirements,
including requirements relating to the validation of tests, training of
personnel, and quality assurance procedures. The laboratory must also be
certified by a government agency. Our Norcross laboratory performs high
complexity tests, and is therefore subject to the most stringent level of
regulation under CLIA. This laboratory is certified under CLIA and licensed by
the state of Georgia. Our failure to comply with state or CLIA requirements can
result in various penalties, including loss of certification. The imposition of
such penalties could have an adverse impact on us. In addition, some states
regulate out-of-state laboratories. The failure to comply with these state
requirements could also adversely affect us.
We are unable to predict the extent of future government regulations or
industry standards. You should assume that in the future there may be more
government regulations or industry standards affecting genetic diagnostic
testing than there are now. Existing or future regulations or industry standards
may have a material adverse effect on our operations, including the cost of
complying with regulations or standards or obtaining permits, delays or fines
resulting from loss of permits or failure to comply with regulations.
CERTAIN SUPPLIES AND PARTS THAT WE NEED ARE AVAILABLE FROM LIMITED SOURCES
We use dyes, reagents and other chemicals supplied by third parties
in our GeneKits. We believe that some dyes supplied by Amersham under our
exclusive worldwide license to use and sell Amersham dyes within our
GeneKits, may not be available from other suppliers, although our customers
might be able to purchase some, but not all, of these dyes directly from
Amersham. In addition, certain reagents and other chemicals which we use and
include in our GeneKits are available only under license from their
manufacturers. We cannot be certain that we will be able to renew these
licenses upon expiration, on favorable terms or at all. While we believe that
alternative dyes, chemicals and reagents are available, alternate products
may not be as effective as certain of the products which we presently use. If
we switched to an alternative dye, chemical or reagent, we may also have to
adapt the GeneKit's analysis software to the new product, which could take
time. If the GeneKit is FDA approved, we may also be required to seek FDA
approval for the altered GeneKit if the alternative product were to
substantially alter the performance of the GeneKit. This could cause delays
in production and in bringing the changed GeneKit to market. See "-Each time
we make alterations to any FDA approved products, we may need to seek
additional FDA approval."
We also use certain custom-designed components supplied by third
parties in our sequencers and other equipment. We believe that there are
alternative suppliers for these custom-designed parts. However, we would incur
costs in switching to alternative suppliers and would likely experience delays
in
12
production of the products that use any of these parts until such time as we
were able to locate alternate suppliers or parts on acceptable terms.
We license the polymerase chain reaction technology that we use in our
GeneKits from Roche Molecular Systems, Inc. and F. Hoffmann La Roche Ltd. These
licenses are 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 for these licenses. One license is for the life of the patents
included within the licensing agreement, which expire at various times
commencing July 2004. The second license expires in February 2003 but will be
automatically extended until July 2004, unless the Roche companies elect not to
renew the license. After the expiration of the initial term of this license, the
Roche companies may terminate the license at any time by giving us a one-year
notice. The termination of either of these licenses would have a material
adverse effect on our ability to produce or sell GeneKits. Consequently, we
could experience a deterioration of anticipated future sales of our GeneKits and
further losses.
WE MAY BE UNABLE TO MANAGE OUR GROWTH
If we are successful in increasing sales and expanding our markets,
there will be additional demands on our management, marketing, distribution,
customer support and other operational and administrative resources and systems.
To accommodate future growth, we may have to hire a substantial number of
additional management personnel and other employees in the United States and
abroad. We may also have to add information and other systems. We cannot
guarantee that we will be able to do so. In addition, our current and future
expense levels are based largely on our investment plans and estimates of future
revenues and are, to a large extent, fixed. We may be unable to adjust spending
in a timely manner to compensate for any unexpected revenue shortfall.
Therefore, any significant shortfall in revenues as compared to our planned
expenditures would materially harm our business, financial condition, and
results of operations. We are not certain whether our current staff, systems and
infrastructure will be adequate to support and effectively monitor future
growth. If we are unable to manage our growth, we may not be able to implement
our business plan and our business, financial condition and results of
operations would be materially harmed.
OUR FUTURE ACQUISITIONS MAY BE DIFFICULT AND DISRUPTIVE, AND WE MAY NOT REALIZE
EXPECTED BENEFITS
We have made and in the future may make acquisitions of complementary
businesses, products, services or technologies. We have limited experience in
integrating newly acquired organizations into our operations.
Acquisitions expose us to many risks, including:
- difficulty in assimilating technologies, products, personnel
and operations;
- diversion of management's attention from other business
concerns;
- large write-offs and amortization expenses related to goodwill
and - other intangible assets;
- entering markets in which we have no or limited experience;
and
- incurrence of debt or assumption of other liabilities.
The occurrence of one or more of these factors could materially harm
our business, financial condition and results of operations.
13
OUR INDUSTRY IS HIGHLY COMPETITIVE
The biotechnology industry is highly competitive. We compete with
entities 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 DNA sequencers such as the
PE Biosystems Group of PE Corporation, Amersham and its
Molecular Dynamics subsidiary, LI-COR, Inc., Hitachi, Ltd. and
Molecular and Genetic BioSystems, Inc.;
- manufacturers and distributors of DNA probe-based diagnostic
systems such as Abbott Laboratories, Chiron Corp., Bayer AG,
Hoffmann-La Roche Inc., Gene Probe Inc., Digene Corporation
and Johnson & Johnson; and
- manufacturers of new technologies used to analyze genetic
information, 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, technical and research and development resources and
production and marketing capabilities than we do. Smaller companies may also
prove to be significant competitors, particularly through collaborative
arrangements with large pharmaceutical and biotechnology companies. If any of
our competitors were to devote significant resources to developing an integrated
solution for genotyping, we would experience significantly more competitive
pressure. We cannot predict whether we could successfully compete with these
pressures and our revenues could suffer.
Our GeneKits also compete with homebrew genetic tests for HIV and other
diseases. Homebrew tests include a variety of small-scale genotyping tests which
typically have not undergone clinical validation and have not been approved by
the FDA or other regulatory agencies.
WE MAY NEED ADDITIONAL CAPITAL AND IF WE ISSUE OR OBTAIN ADDITIONAL FINANCING,
WE MAY NEED THE PRIOR CONSENT OF THE HOLDERS OF OUR SERIES A PREFERRED SHARES
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, including proceeds from our recently completed equity financing, and
anticipated funds from operations will be sufficient to enable us to meet our
operating needs for the next 12 months. However, the actual amount of funds that
we will need during
14
the next 12 months will be determined by many factors, some of which are beyond
control. These factors include:
- our success in selling our products in the research and
clinical research markets during this period;
- our ability to obtain FDA approval to sell our HIV GeneKit and
related equipment for clinical diagnostic purposes;
- if we obtain FDA approval, the acceptance of our HIV products
by the clinical diagnostic market;
- the decision of third-party payors to reimburse clinicians and
patients for use of our HIV products;
- the success of our distribution partners in marketing and
selling our products in selected markets;
- progress with research and development;
- our success in introducing new products during the period;
- our ability to manage growth;
- our incurring significant fixed overhead and other expenses
prior to increasing our revenues;
- the costs of acquiring and integrating any new business or
technologies during the period;
- the results of any other strategic relationships into which we
may enter during the period;
- the costs and timing of obtaining new patent rights;
- regulatory changes;
- competition; and
- technological developments in the market.
We may need to obtain additional funds sooner or in greater amounts
than we currently anticipate and we may need to obtain additional funds at
the end of the 12 month period. Because of our potential long-term capital
requirements, we may seek to access the public or private equity markets
whenever conditions are favorable, even if we do not have an immediate need
for additional capital at that time. If we need to obtain funds at the end of
12 months, or earlier, potential sources of financing include strategic
relationships, public or private sales of our shares or debt or other
arrangements. We do not have any committed sources of financing at this time
and it is uncertain whether additional funding will be available when we need
it on terms that will be acceptable to us or at all. If we raise funds by
selling additional common shares or other securities convertible into common
shares, the ownership interest of our existing shareholders will be diluted.
If we are not able to obtain financing when needed, we would be unable to
carry out our business plan, we would have to significantly limit our
operations and our business, financial condition and results of operations
would be materially harmed.
If we wish to issue equity securities or obtain additional financing,
we may need the consent of our shareholders holding Series A preferred shares of
our company. We will be required to obtain the consent of the holders of a
majority of our then outstanding Series A preferred shares prior to issuing any
15
equity security that has rights as to dividends and liquidation that are senior
or equal to those of the Series A preferred shares. Also, under certain
circumstances, if we propose to sell equity securities, including debt
securities convertible into equity securities, certain shareholders of our
Series A preferred shares will be entitled to preemptive rights which allow them
to purchase a proportional amount of the securities being offered. We will also
be required to obtain the consent of the holders of a majority of our then
outstanding Series A preferred shares if we wish to borrow money and at such
time or as a result of such loans, the total principal amount of our
indebtedness and capitalized lease obligations exceeds $15.0 million. In
addition, if we were to enter into a credit facility with a financial
institution, we may be subject to additional limitations on our ability to incur
additional indebtedness. As a result of the above, we may be delayed in, or
prohibited from, obtaining certain types of financing. See "Description of
Capital Shares."
WE DEPEND ON QUALIFIED SCIENTIFIC, TECHNICAL AND MANAGEMENT PERSONNEL
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 and sales
and marketing personnel as our business expands. Competition in our industry for
scientific, sales and marketing and management personnel is intense. Loss of the
services of our key personnel in these areas 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.
WE MAY BE SUBJECT TO PRODUCT LIABILITY CLAIMS
The testing, manufacturing, sale and marketing of our products exposes
us to the risk of product liability claims. Although we have obtained product
liability insurance coverage, we cannot guarantee 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.
WE MAY BE SUBJECT TO LIABILITY CLAIMS BASED ON ERRORS IN OUR TESTING SERVICES
We provide DNA testing, sequencing and other services for HIV,
hepatitis B, hepatitis C and other infectious diseases, as well as for certain
cancers. These services may be used in the future by clinicians to diagnose or
treat their patients. Clinicians, patients and others may at times seek damages
for the misdiagnosis of a patient's disease based on testing errors, for the
erroneous recommendation of drug treatment based on a technician's misreading of
the sequencing results, mishandling of the patient samples or similar claims.
Although we have obtained liability insurance coverage, we cannot guarantee that
liability insurance will continue to be available to us on acceptable terms or
that our coverage will be sufficient to protect us against all claims that may
be brought against us. A 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.
WE FACE RISKS RELATING TO OUR INTERNATIONAL OPERATIONS
We sell our products in Europe, Asia and South America and operate
offices in Europe. Therefore, we are subject to certain risks that are inherent
in an international business. These include:
- varying regulatory restrictions on sales of our products to
certain markets and unexpected changes in regulatory
requirements;
16
- tariffs, customs, duties and other trade barriers;
- difficulties in managing foreign operations and foreign
distribution partners;
- longer payment cycles and problems in collecting accounts
receivable;
- political risks;
- fluctuations in currency exchange rates;
- foreign exchange controls which may restrict or prohibit
repatriation of funds;
- export and import restrictions or prohibitions, and delays
from customs brokers or government agencies;
- seasonal reductions in business activity in certain parts of
the world; and
- potentially adverse tax consequences resulting from operating
in multiple jurisdictions with differing tax laws.
Depending on the countries involved, any or all of the foregoing
factors could materially harm our business, financial condition and results of
operations.
U.S. INVESTORS IN OUR COMPANY COULD SUFFER ADVERSE TAX CONSEQUENCES IF
WE ARE CHARACTERIZED AS A PASSIVE FOREIGN INVESTMENT COMPANY
Although we do not believe that we were a passive foreign investment
company (or PFIC) for United States federal income tax purposes during 1998,
there can be no assurance that we will not be treated as a PFIC in 1999 or
thereafter. We would be a PFIC if 75% or more of our gross income in a taxable
year is passive income. We would also be a PFIC if at least 50% of our assets
averaged over the taxable year produce, or are held for the production of,
passive income. Passive income includes, among other items, interest, dividends,
royalties, rents and annuities. If we are or become a PFIC, many of our U.S.
shareholders will be subject to the following adverse tax consequence:
- they will be taxed at the highest ordinary income tax rates in
effect during their holding period on certain distributions on
our common shares, and gain from the sale or other disposition
of our common shares;
- they will be required to pay interest on taxes allocable to
prior periods; and
- the tax basis of our common shares will not be increased to
fair market value at the date of their death.
If we are or become a PFIC, our U.S. shareholders could avoid these tax
consequences by making a qualified electing fund election or a mark-to-market
election (a mark-to-market election, however, will not provide for an increase
of our common shares to fair market value at the date of their death). These
elections would need to be in effect for all taxable years during which we were
a PFIC and during which our U.S. shareholders held our common shares. If a U.S.
shareholder makes a qualified electing fund election, he will be taxed currently
on our ordinary income and net capital gain (unless a deferral election is in
effect). If a U.S. shareholder makes a mark-to-market election, he will include
as ordinary income each year an amount equal to the excess of the fair market
value of our common shares over his adjusted tax basis as of the close of each
year (with certain adjustments for prior years).
17
If we are or become a PFIC, our U.S. shareholders will generally be
unable to exchange our common shares for common shares of an acquiring
corporation on a tax-deferred basis under the reorganization rules of the
Internal Revenue Code, and many other nonrecognition provisions of the Internal
Revenue Code will not apply to transfers of our common shares. In addition, if
we are or become a PFIC, pledges of our common shares will be treated as sales
for federal income tax purposes. Our U.S. shareholders should note that state
and local taxes may also apply if amounts are included in federal taxable income
under the PFIC rules of the Internal Revenue Code. The PFIC rules are very
complex. Our U.S. shareholders are strongly encouraged to consult with their tax
advisor concerning all of the tax consequences of investing in our common shares
and the possible benefits of making a tax election given their circumstances.
Additionally, our U.S. shareholders should review the section entitled "U.S.
Federal Income Tax Considerations" contained in our Annual Report on Form 20-F
for a more detailed description of the PFIC rules and how they may affect their
ownership of our common shares.
OUR UNLIMITED PREFERRED SHARES, CLASSIFIED BOARD OF DIRECTORS AND SERIES A
DIRECTOR COULD PREVENT OR DELAY TAKEOVERS AND, OUR PREFERRED SHARES CONTAIN
PREFERENCES OVER OUR COMMON SHARES
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."
In July 1999, we issued 33,948 Series A preferred shares. Our Series A
preferred shares entitle the holders to certain preferences over our common
shares, including the following:
- we may not issue any securities that rank senior to, or in
parity with, the Series A preferred shares without obtaining
the approval of the holders of a majority of the Series A
preferred shares;
- we may not issue dividends to holders of common shares until
all accrued and unpaid dividends on the Series A preferred
shares are paid in full; and
- if we liquidate or wind-up our company or if we sell our
company or in certain other circumstances, holders of Series A
preferred shares are entitled to receive an amount equal to
$1,000 per Series A preferred share, or approximately $34.0
million in the aggregate, plus accrued and unpaid dividends,
before holders of common shares would be entitled to receive
any distribution.
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.
Also, the holders of our Series A preferred shares are entitled to vote
as a class for one director. Each Series A Director serves for a one year term
and any vacancy may be filled only by a vote of the holders of Series A
preferred shares. In the event that we do not redeem our Series A preferred
shares as required during 2006, 2007 and 2008, then our Series A shareholders
will be entitled to special voting
18
rights enabling them to elect a majority of our Board of Directors, who will
continue to serve as directors until we have redeemed our Series A preferred
shares as required.
Having a classified Board of Directors and a Series A director 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.
THE VOLATILITY OF THE STOCK MARKET COULD DRIVE DOWN THE PRICE OF OUR 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 that
may have the effect of temporarily or permanently driving down the price of our
common shares include:
- failure to obtain FDA approval for our HIV OpenGene System;
- publicizing poor quarterly financial results;
- biological or medical discoveries by competitors;
- failed technological innovations;
- unfavorable domestic or foreign regulatory developments; and
- unfavorable developments concerning patents or other
proprietary rights.
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 make it difficult for a shareholder to sell shares at a
price equal to or above the price at which the shares were purchased.
FUTURE SALES OF ELIGIBLE SHARES MAY LOWER THE PRICE OF OUR COMMON SHARES
As of October 29, 1999, we have outstanding 9,648,754 common shares,
not including the shares covered by this prospectus. All of those shares are
eligible for sale under Rule 144, or are otherwise freely tradable, except for
those common shares held by our affiliates.
The common shares covered by this prospectus will be issued upon
exercise of the warrants and/or conversion of the Series A preferred shares and
will be freely tradable for as long as this Registration Statement remains
effective.
In addition:
- Our affiliates own 2,352,048 shares which may be sold subject
to volume restrictions imposed by Rule 144. Our affiliates
also own options to acquire an additional 240,000 shares. The
shares to be issued upon exercise of these options have been
registered or are being registered concurrently with this
Registration Statement and may be freely sold when issued.
- Our employees (who are not deemed affiliates) hold options to
buy a total of 1,423,042 shares. The shares to be issued upon
exercise of these options have been registered or are being
registered concurrently with this Registration Statement and
may be freely sold when issued.
19
- 587,154 shares, and an additional 76,734 shares issuable upon
exercise of outstanding warrants, are registered for sale
pursuant to registration statements filed with the Securities
and Exchange Commission, and may be freely sold.
- We may issue options to purchase up to an additional 251,793
shares under our stock option plans. The shares to be issued
upon exercise of these options have been registered or are
being registered concurrently with this Registration Statement
and may be freely sold when issued.
Sales of substantial amounts of common shares into the public market
could lower the market price of our common shares.
In general, under Rule 144 as currently in effect, a person (or persons
whose shares are required to be aggregated) who has owned shares for at least
one year would be entitled to sell within any three-month period a number of
shares that does not exceed the greater of (i) 1% of the number of our common
shares then outstanding (which will equal approximately 96,488 shares
immediately upon the effective date of this prospectus) or (ii) the average
weekly trading volume of our common shares during the four calendar weeks
preceding the filing of a Form 144 with respect to such sale. Sales under Rule
144 are also subject to certain manner of sale provisions and notice
requirements and to the availability of current public information about our
company. Under Rule 144(k), a person who is not deemed to have been our
affiliate at any time during the three months preceding a sale, and who has
owned the shares proposed to be sold for at least two years, is entitled to sell
his shares without complying with the manner of sale, public information, volume
limitation or notice provisions of Rule 144.
WE FACE FOREIGN CURRENCY EXCHANGE RISKS
Our financial statements are prepared in U.S. dollars and much of our
business is conducted in U.S. dollars. However, we do incur 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
risks 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 limited foreign exchange hedging activities by purchasing
Canadian funds before they are actually required to protect ourselves against
the risk of losses due to fluctuations in exchange rates. We do not currently
engage in hedging activities for any other foreign currencies. We may suffer
losses as a result of fluctuations in the exchange rates between the U.S.
dollar and foreign currencies.
WE FACE RISKS RELATING TO YEAR 2000 ISSUES
Beginning on January 1, 2000, some computer systems and software will
produce erroneous results or fail unless they have been modified or upgraded to
process date information correctly. We have conducted a comprehensive
examination of our information technology systems, software applications and
software applications sold with our products to determine compliance with the
year 2000. Based on our examination, we believe that these systems and software
applications are year 2000 compliant.
We have contacted our material customers, suppliers and third-party
service providers to identify year 2000 problems and provide solutions to
prevent any disruption of business activities. We completed a review of the
compliance efforts by these parties in the third quarter of 1999. Based on the
information we have received, our most significant year 2000 risk would involve
disruption of our material supply and distribution channels, and in particular
the supply of certain instrument parts and supplies from single-source
suppliers. This would likely lead to material interruption in product
development and sales of our products. In addition, we could encounter
significant expenses in remedying any problems or switching to year 2000
compliant vendors and suppliers.
20
FORWARD-LOOKING STATEMENTS
This prospectus includes forward-looking statements. You can identify
these forward-looking statements when you see us using words such as "expect,"
"anticipate," "estimate," "believe," "intend," "may," "predict," and other
similar expressions. These forward looking statements cover, among other items:
- acceptance of our products in the clinical diagnostic market;
- acceptance of genotyping in the clinical diagnostic market;
- our marketing and sales plans;
- our expectations about the markets for our products;
- the performance of our products;
- our intention to introduce new products;
- our future capital needs;
- FDA and other regulatory approval for certain of our products;
- our proposed clinical trials;
- reimbursement of our products by insurance companies and other
third-party payors;
- our ability to compete in the research, clinical research and
clinical diagnostic markets;
- our patent applications; and
- the status of year 2000 compliance efforts of our company, and
our material customers and suppliers.
We have based these forward-looking statements largely on our current
expectations. However, forward-looking statements are subject to a number of
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 under "Risk Factors" including, among others:
- delays in obtaining, or our inability to obtain, approval by
the FDA and other regulatory authorities for our HIV OpenGene
System and, in the future, certain of our other products for
the clinical diagnostic market;
- refusal of insurance companies and other third-party payors to
reimburse patients and clinicians for our products;
- uncertainty of acceptance of genotyping, in general, and of
our products, in particular, in the clinical diagnostic
market;
- problems, delays and expenses we may face with our proposed
clinical trials;
- problems that we may face in manufacturing, marketing and
distributing our products;
21
- delays in the issuance of, or the failure to obtain, patents
or licenses for certain of our products and technologies;
- problems with important suppliers and business partners;
- delays in developing, or the failure to develop, new products
and enhanced versions of existing products; and
- the timing of our future capital needs or our inability to
raise additional capital when needed.
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 statements and
circumstances discussed in this prospectus might not transpire.
22
USE OF PROCEEDS
All of the common shares offered by this prospectus are being offered
by the selling shareholders. We will not receive any proceeds from sales of
common shares by the selling shareholders.
DIVIDEND POLICY
SERIES A PREFERRED SHARES. Dividends on our Series A preferred shares
accrue at the rate of 9% per year during the first three years after issuance,
and 4% per year thereafter. Dividends will not be payable for the first three
years. After three years, at our option, we may pay dividends in cash. If
dividends are not paid in cash, they will continue to accrue and will be
convertible into additional common shares upon conversion of the preferred
shares. See "Description of Capital Shares."
COMMON SHARES. We have not declared or paid any cash dividends on our
common shares. We currently intend to retain any future earnings for use in the
operation and expansion of our business. We do not anticipate paying any cash
dividends on our common shares in the foreseeable future.
23
SELECTED CONSOLIDATED FINANCIAL DATA The
following selected consolidated financial data set forth below should be read
in conjunction with "Management's Discussion and Analysis of Financial
Condition and Results of Operations" and our Consolidated Financial
Statements and the Notes thereto included in our Annual Report on Form 20-F,
incorporated into the prospectus by reference. The Consolidated Statement of
Operations data for fiscal years 1996, 1997 and 1998 and the Consolidated
Balance Sheet data as of December 31, 1997 and 1998, as set forth below, have
been derived from our consolidated financial statements included in our
Annual Report on Form 20-F, which have been audited by PricewaterhouseCoopers
LLP, Chartered Accountants in Canada, whose report with respect to such
financial statements appears in our Annual Report on Form 20-F. The
Consolidated Statement of Operations data for fiscal years 1994 and 1995 and
the Consolidated Balance Sheet data as of December 31, 1994, 1995 and 1996,
as set forth below, have been derived from audited consolidated financial
statements not included in this prospectus. The Consolidated Statement of
Operations data for the nine-month periods ended September 30, 1998 and 1999
and the Consolidated Balance Sheet data as of September 30, 1999 are derived
from unaudited consolidated financial statements included in our Report on
Form 6-K Filing No. 1 for the Month of November 1999, dated November 10,
1999, and incorporated into this prospectus by reference, which in the
opinion of our management, reflect all adjustments, consisting only of normal
recurring adjustments, necessary to present fairly the financial data for
such period. Historical results are not necessarily indicative of results to
be expected for any future period.
SUMMARY CONSOLIDATED FINANCIAL INFORMATION
(in thousands, except number of common shares outstanding and net loss per share
amounts)
FISCAL YEAR ENDED DECEMBER 31,
-----------------------------------------------------------------------------
STATEMENT OF OPERATIONS 1994 1995 1996 1997 1998
---- ---- ---- ---- ----
Sales $ -- -- $ 978 $ 3,033 $ 10,875
Cost of Sales -- -- 561 1,995 6,673
Gross margin -- -- 417 1,038 4,202
Sales, general and administrative
expense 450 1,476 3,377 7,448 11,516
Research and development 482 1,241 2,745 4,123 6,289
Other -- -- -- 654 420
Loss from operations before
interest (932) (2,717) (5,705) (11,187) (14,023)
Interest income 9 12 609 774 264
Interest and financing
expense -- (19) (69) (3) (1,132)
Net (loss) $ (923) $ (2,724) $ (5,165) $ (10,416) $ (14,891)
Net (loss) per share $ (0.32) $ (0.65) $ (0.89) $ (1.48) $ (1.91)
Weighted average number of
Common shares outstanding 2,902,735 4,181,599 5,791,367 7,059,578 7,782,094
NINE MONTHS ENDED
SEPTEMBER 30,
-------------------------
STATEMENT OF OPERATIONS 1998 1999
---- ----
(unaudited)
Sales $ 6,797 $ 8,672
Cost of Sales 4,406 6,318
Gross margin 2,391 2,354
Sales, general and administrative
expense 7,655 13,409
Research and development 5,005 5,986
Other -- --
Loss from operations before
interest (10,269) (17,041)
Interest income 200 351
Interest and financing
expense (434) (1,783)
Net (loss) $ (10,503) $ (18,473)
Net (loss) per share $ (1.42) $ (2.03)
Weighted average number of
Common shares outstanding 7,416,393 9,508,358
FISCAL YEAR ENDED DECEMBER 31, SEPTEMBER 30,
1994 1995 1996 1997 1998 1999
---- ---- ---- ---- ---- ------------
(UNAUDITED)
BALANCE SHEET DATA
Cash and short-term investment $ 633 $ 403 $ 18,928 $ 7,588 $ 11,274 $ 18,956
Working capital $ 869 $ 418 $ 20,061 $ 9,561 $ 8,432 $ 24,656
Indebtedness -- $ 500 -- -- $ 7,495 --
Total assets $ 1,217 $ 1,791 $ 22,606 $ 13,936 $ 27,783 $ 36,315
Shareholders' equity $ 1,040 $ 841 $ 21,795 $ 12,610 $ 14,579 $ 4,723
24
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis in conjunction
with "Selected Consolidated Financial Data" and our Consolidated Financial
Statements and Notes thereto included elsewhere in this prospectus. In addition
to historical information, the following discussion contains certain
forward-looking statements that involve known and unknown risks and
uncertainties, such as statements of our plans, objectives, expectations and
intentions. Our actual results could differ materially from those discussed in
the forward-looking statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed below and in the
section entitled "Risk Factors," and "Forward Looking Statements" as well as
those discussed elsewhere herein.
OVERVIEW
We began operations in 1993. Until 1996, we devoted substantially all
of our resources to the research and development of our technology and products.
In late 1996, we began manufacturing and selling our products to the research
and clinical research markets.
- Our products and services are described below.
- SEQUENCING SYSTEMS. Sequencing systems consist of automated
DNA sequencers and related equipment, and our proprietary DNA
analysis and data management software.
- GENEKITS AND OTHER CONSUMABLES. GeneKits consist of various
reagents, enzymes, primers and other chemicals, and other
consumables consist of disposable gel cassettes, acrylamide
and other materials.
TESTING, SEQUENCING AND OTHER SERVICES. We provide services, such as
viral load testing, genotyping and other molecular services, through our
wholly-owned subsidiaries, Applied Sciences, Inc., which we acquired in
1997, and ACT Gene S.A., which we acquired in 1998.
During 1996 and 1997, we generated revenues primarily by selling
sequencing systems. During this period, our business strategy focused on
installing our DNA sequencers and related equipment in research and clinical
research facilities. During 1998, we began to shift our strategy to target the
clinical diagnostic market and to place greater emphasis on generating recurring
revenues from sales of GeneKits and other consumables initially to the research
and clinical research markets and, subject to FDA approval, to the clinical
diagnostic market. As part of this strategy, we may sell our DNA sequencers at
reduced prices to customers who commit to purchase significant quantities of
GeneKits and other consumables, or we may bundle the sequencers and GeneKits for
sale at favorable prices. This strategy may result, initially, in reduced gross
margins and additional losses as we attempt to expand our installed base of DNA
sequencers. However, we believe that this strategy, over the long term, will
help us maximize recurring sales of our HIV GeneKit and other GeneKits to the
clinical diagnostic market, should we receive FDA approval.
OUR OPERATIONS
SALES. Sales consist of revenues from the sale of sequencing systems,
GeneKits and other consumables as well as from the sale of testing services.
Sales include shipping charges, but exclude sales and excise taxes. Revenue from
the sale of our products is recognized when shipment occurs and title passes to
the customer. Revenue from the sale of testing and other services is recognized
when the service is provided and there is a reasonable assurance of
collectibility. Sales of bundled sequencing systems and GeneKits are recognized
proportionately as the components of the bundle are shipped to customers. The
total sales price of the bundle is allocated to the components proportionately
based on the retail prices
25
typically charged for such components if they were sold individually rather than
as part of the bundle. For an analysis of sales by product segment and
geographic market, see Note 12 to our Consolidated Financial Statements.
COST OF SALES. Cost of sales consists of manufacturing costs including
materials, labor and overhead chargeable to inventory. The gross margin from
sales of our products and services varies depending on product category,
distribution channel and geographic market. Gross margin is calculated by
subtracting cost of sales from sales. We sell our products in North America,
Europe, Asia, Australia and South America. In the United States, Canada and many
countries in Europe, we sell our products directly through our own sales force.
In selected geographic and product markets, we seek to sell our products through
distribution, marketing or agency agreements with leading distributors.
Currently, we have entered into agreements with distributors in Spain, Portugal,
Japan, Australia, New Zealand, Argentina and Brazil.
SALES, GENERAL AND ADMINISTRATIVE EXPENSES. Sales, general and
administrative expenses consist primarily of salaries and related expenses,
occupancy costs, utilities, professional fees, consulting fees, travel costs,
capital taxes, depreciation of fixed assets and amortization of costs paid to
patent counsel.
RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses
consist primarily of salaries and related expenses for employees engaged in
research and development, occupancy costs, consulting fees, travel costs,
depreciation and amortization of fixed assets and costs related to FDA clinical
trials for our HIV OpenGene System.
INTEREST INCOME. Interest income consists of income earned on cash,
cash equivalents and marketable securities.
INTEREST AND FINANCING EXPENSE. Interest and finance expense consists
of interest paid or accrued, and amortization of warrant costs and other
financing expenses.
Our financial statements are presented in U.S. dollars and are prepared
in accordance with generally accepted accounting principles in the United
States.
RESULTS OF OPERATIONS
COMPARISON OF NINE MONTHS ENDED SEPTEMBER 30, 1999 TO NINE MONTHS ENDED
SEPTEMBER 30, 1998
SALES. Sales increased 28% to $8.7 million for the nine months ended
September 30, 1999, compared with $6.8 million for the same period of the prior
year. This increase resulted primarily from increased sales of our GeneKits and
other consumables. In the nine months ended September 30, 1999, automated DNA
sequencing systems accounted for 57% of total sales, compared to approximately
73% of total sales in the same period of the prior year. GeneKits and other
consumables accounted for 33% of total sales, compared to approximately 13% of
total sales in the same period of the prior year. Testing services accounted for
10% of total sales, compared to 14% of total sales in the same period of the
prior year. Sales in North America, Europe, and Asia and South America were $3.9
million, $3.4 million and $1.4 million, respectively, during the nine months
ended September 30, 1999, as compared to $5.6 million, $1.0 million and $0.2
million, respectively, during the nine months ended September 30, 1998.
COST OF SALES. Cost of sales increased to $6.3 million for the nine
months ended September 30, 1999, from $4.4 million in the same period of the
prior year. In the nine months ended September 30, 1999, cost of sales
aggregated 73% of sales, compared to 65% of sales in the same period of the
prior year. This increase in cost of sales was primarily related to the
increase in sales and a write-off of obsolete and discontinued instruments
and related parts totaling $0.62 million recorded in the second quarter of
1999.
26
SALES, GENERAL AND ADMINISTRATIVE EXPENSES. Sales, general and
administrative expenses increased 75% to $13.4 million for the nine months ended
September 30, 1999, compared with $7.7 million for the same period of the prior
year. This increase resulted primarily from increased payroll and personnel
costs due to the continued growth of our business, costs of quality control and
regulatory departments established in 1998 and the continued expansion of our
sales force in North America and Europe. Sales and marketing expenses included
in sales, general and administrative expenses increased 93% to $7.0 million for
the nine months ended September 30, 1999, compared with $3.6 million for the
same period of the prior year.
RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses
increased 20% to $6.0 million for the nine months ended September 30, 1999,
compared with $5.0 million for the same period of the prior year. This increase
resulted from increased payroll and personnel costs, along with increased
purchases of laboratory supplies, as we developed additional GeneKits and
continued our research programs. Additionally, we incurred costs for
pre-clinical and clinical trials related to our FDA submission for our HIV
OpenGene System.
INTEREST INCOME. Interest income was $0.4 million for the nine months
ended September 30, 1999, compared with $0.2 million for the same period of the
prior year.
INTEREST AND FINANCING EXPENSE. Interest and financing expense
increased to $1.8 million for the nine months ended September 30, 1999, compared
with $0.4 million for the same period of the prior year. This increase was due
to interest and financing costs on our term loan agreements entered into in
April and September 1998 and the Warburg Pincus financing in July 1999. See
"Liquidity and Capital Resources." Of the total interest and financing expense,
$1.3 million was a non-cash charge due to the amortization of costs attributable
to warrants issued in connection with our term loans and the Warburg Pincus
financing, compared to $0.2 million for the same period of the prior year.
COMPARISON OF FISCAL YEAR ENDED DECEMBER 31, 1998 TO FISCAL YEAR ENDED DECEMBER
31, 1997
SALES. Sales increased 259% to $10.9 million in 1998 from $3.0 million
in 1997. This increase resulted from increased sales of our automated DNA
sequencers, GeneKits and other consumables and testing services. In 1998, 412
automated DNA sequencing systems were sold, an increase of 353% from the 91
systems sold in 1997. In 1998, automated DNA sequencing systems accounted for
74% of sales, compared to 90% of sales in 1997. GeneKits and other consumables
accounted for 13% of sales in 1998, compared to 8% in 1997. Testing services
accounted for 13% of sales in 1998 compared to 2% of sales in 1997 as a result
of our acquisition in 1998 of a DNA diagnostic testing company. Sales during
1998 in North America, Europe, and Asia and South America were $7.4 million,
$3.0 million and $0.5 million, respectively, as compared to $2.8 million, $0.2
million and $0.05 million, respectively, during 1997.
COST OF SALES. Cost of sales increased to $6.7 million in 1998 from
$2.0 million in 1997. In 1998, cost of sales aggregated 61% of sales, a decrease
from 66% of sales in 1997. Cost of sales decreased in 1998 as a percentage of
sales due to improvements in our manufacturing processes, as well as economies
of scale as production of automated DNA sequencing systems, GeneKits and other
consumables increased compared to the previous year.
SALES, GENERAL AND ADMINISTRATIVE EXPENSES. Sales, general and
administrative expenses increased 55% to $11.5 million in 1998 from $7.4 million
in 1997. This increase resulted primarily from increased payroll and personnel
costs due to the growth of our business, establishment of quality control and
regulatory departments and development of a sales force in North America and in
certain countries in
27
Europe. Sales and marketing expenses included in sales, general and
administrative expenses increased 126% to $6.1 million in 1998 from $2.7 million
in 1997.
RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses
increased 53% to $6.3 million in 1998 from $4.1 million in 1997. This increase
in research and development expenses resulted from increased payroll and
personnel costs along with increased purchases of laboratory supplies as we
continued to develop GeneKits and expanded our research programs.
In April 1998, we acquired 100% of the shares of ACT Gene S.A., a DNA
diagnostic testing company, for 85,000 common shares and cash payable of $0.7
million. This acquisition was accounted for as a purchase, and resulted in the
recording of an excess of purchase price over tangible net assets of $0.5
million, of which $0.4 million was determined to be in-process research and
development, and reflected as an expense in 1998.
INTEREST INCOME. Interest income declined to $0.3 million in 1998 from
$0.8 million in 1997.
INTEREST AND FINANCING EXPENSE. Interest and financing expense
increased to $1.1 million in 1998 from approximately nil in 1997 due to interest
paid or accrued and the amortization of costs attributable to warrants issued in
connection with term loans entered into in April and September 1998.
COMPARISON OF FISCAL YEAR ENDED DECEMBER 31, 1997 TO FISCAL YEAR ENDED DECEMBER
31, 1996
SALES. Sales increased 210% to $3.0 million in 1997 from $1.0 million
in 1996. This increase resulted from increased sales of our automated DNA
sequencers and GeneKits and other consumables. In 1997, 91 automated DNA
sequencing systems were sold, an increase of 112% from the 43 systems sold in
1996. In 1997, automated DNA sequencing systems accounted for 89% of total
sales, compared to 95% of total sales in 1996. GeneKits and other consumables
accounted for 9% of total sales in 1997, compared to 5% of total sales in 1996.
Sales during 1997 in North America, Europe, and Asia and South America were $2.8
million, $0.2 million and $0.05 million, respectively, as compared to $0.8
million, $0.1 million and nil, respectively, during 1996.
COST OF SALES. Cost of sales increased to $2.0 million in 1997 from
$0.6 million in 1996. In 1997, cost of sales aggregated 66% of sales as compared
to 57% of sales in 1996. Cost of sales increased in 1997 as a percentage of
sales due to capacity constraints and various manufacturing challenges as
production increased to meet demand.
SALES, GENERAL AND ADMINISTRATIVE EXPENSES. Sales, general and
administrative expenses increased 121% to $7.4 million in 1997 from $3.4 million
in 1996. This increase primarily resulted from increased payroll and personnel
costs as we hired additional selling, marketing, administrative and management
personnel due to our growth, and the costs of developing a sales force in North
America and certain countries in Europe. Sales and marketing costs included in
sales, general and administrative expenses increased to $2.7 million in 1997
from $0.7 million in 1996.
RESEARCH AND DEVELOPMENT EXPENSES. Research and development expenses
increased 50% to $4.1 million in 1997 from $2.7 million in 1996. This increase
resulted from increased payroll and personnel costs along with increased
purchases of laboratory supplies as we established a research facility in
Pittsburgh, the continued development of GeneKits at our main lab in Toronto and
with outside researchers and increased design and development costs associated
with our OpenGene System.
Effective October 1997, we acquired Applied Sciences, Inc., a
Georgia-based diagnostics company specializing in HIV genotyping. This
acquisition was accounted for as a purchase and resulted in the recording of an
excess of purchase price over tangible assets of $0.7 million. This amount was
determined to be in-process research and development and was reflected as an
expense in 1997.
28
INTEREST INCOME. Interest income increased to $0.8 million in 1997 from
$0.6 million in 1996. This increase resulted because in 1996 we earned only six
months' interest following our initial public offering in June 1996.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, we have financed our operations primarily through
private placements of equity, with aggregate net proceeds of approximately $47.7
million, and an initial public offering in June 1996, which raised net proceeds
of approximately $25.8 million. We have also borrowed $8.0 million from
institutional lenders and in the past utilized a bank credit facility.
BANK CREDIT FACILITY. In 1997, we obtained a bank line of credit for up
to $1.1 million from the Royal Bank of Canada. The loan was secured by a lien on
our accounts receivable, inventory and fixed assets. In April 1998, the bank
line was repaid and the line was cancelled.
INSTITUTIONAL LOANS. On April 30, 1998, our subsidiary, Visible
Genetics Corp., or VGC, borrowed $7.0 million from various funds for which Hilal
Capital Management LLC serves as investment advisor or management company. We
refer to these funds in this prospectus as our "institutional lenders" or the
"Hilal funds." In September 1998, VGC borrowed an additional $1.0 million from
these lenders. The interest rate of the loans was 10% per year. Interest and
principal on the $7.0 million loan were payable on or about April 29, 1999, and,
on the $1.0 million loan, were payable on December 28, 1999.
On April 30, 1999, we and the institutional lenders agreed to delay the
payment date of the $7.0 million loan to December 31, 1999, and to move up the
payment date of the $1.0 million loan to July 1, 1999. The institutional lenders
later extended the payment date to the earlier of July 22, 1999, or the
completion of the Warburg Pincus financing (described below). In addition, the
institutional lenders agreed to permit us to borrow up to an additional $5.0
million of loans from other lenders which would be senior to the $7.0 million
loan and junior to the $1.0 million loan.
We guaranteed VGC's obligations under both loans. We gave the
institutional lenders a security interest in most of our assets to secure our
obligations under the guaranty, including a pledge of the outstanding stock of
VGC. Both the loan agreements and the guaranty imposed certain restrictions on
us and our subsidiaries, including limitations on loans and other obligations
which we may incur.
As part of the loan arrangements, we granted the institutional lenders
warrants to purchase our common shares. Initially, we granted the institutional
lenders warrants to purchase 420,000 common shares which may be exercised until
April 2003, at a price of $10.00 per share. When we borrowed an additional $1.0
million from the institutional lenders in September 1998, we granted them
warrants for an additional 120,000 common shares which may be exercised until
September 2003, at a price of $10.00 per share. On April 30, 1999, we granted
the institutional lenders warrants to purchase an additional 140,000 common
shares which may be exercised until April 30, 2006, at a price of $17.00 per
share. As a result, non-cash charges of $0.6 million were recorded as financing
expenses in 1998.
On July 15, 1999, we repaid all of the loans made to us by the Hilal
Funds. Of the $8.0 million principal amount of the loans, we paid $4.1 million
of principal plus accrued interest on the loan in cash. The Hilal Funds
converted the remaining $3.9 million principal amount plus accrued interest into
3,948 Series A preferred shares and 147,098 warrants to purchase our common
shares. The Series A preferred shares and warrants have the same terms as
those granted to Warburg Pincus (as described below).
WARBURG PINCUS FINANCING. On July 15, 1999, certain affiliated funds
managed by E.M. Warburg, Pincus & Co., LLC, invested $30.0 million in our
company. In consideration for this investment, we issued to the Warburg Pincus
Funds 30,000 Series A preferred shares convertible at the
29
holders' option into common shares at $11.00 per share, and warrants to purchase
1,100,000 common shares exercisable for four years at a purchase price of $12.60
per share. For a description of the Series A preferred shares and the warrants,
see "Description of Capital Shares."
CAPITAL EXPENDITURES. Additions to fixed assets were approximately $0.8
million, $1.1 million and $3.3 million for the years ended December 31, 1996,
1997 and 1998, respectively and $1.5 million for the nine months ended September
30, 1999. We expect capital expenditures to increase over the next several years
as we expand our facilities and acquire additional manufacturing and scientific
equipment.
CURRENT AND FUTURE FINANCING NEEDS. We have incurred negative cash flow
from operations since we started our business. We have spent, and expect to
continue to spend, substantial amounts to complete our planned product
development efforts, expand our sales and marketing activities, conduct our
clinical trials, conduct research, build our business infrastructure and expand
our manufacturing capabilities. At this time, funds from operations are not
sufficient to meet our operating needs and other anticipated financial
requirements.
We believe, based on our current plans, that our cash on hand and
anticipated funds from operations will be sufficient to enable us to meet our
operating needs for the next 12 months. However, the actual amount of funds
we will need to operate for the next 12 months is subject to many factors,
some which are beyond are control. We may need to obtain additional funds
sooner or in greater amounts than we currently anticipate and we may need to
obtain additional funds at the end of the 12 month period. If we need to
obtain funds at the end of 12 months, or earlier, potential sources of
financing include strategic relationships, public or private sales of our
shares or debt or other arrangements. We do not have any committed sources of
financing at this time and it is uncertain whether additional funding will be
available when we need it on terms that will be acceptable to us or at all.
If we raise funds by selling additional common shares or other securities
convertible into common shares, the ownership interest of our existing
shareholders will be diluted. If we are not able to obtain financing when
needed, we would be unable to carry out our business plan, we would have to
significantly limit our operations and our business, financial condition and
results of operations would be materially harmed.
If we wish to issue equity securities or obtain additional
financing, we will need the consent of the Series A preferred shareholders
under certain circumstances. We will be required to obtain the consent of the
holders of a majority of the then outstanding Series A preferred shares prior
to issuing any equity security that has rights as to dividends and
liquidation that are senior or equal to those of the Series A preferred
shares. We will also be required to obtain the consent of the holders of a
majority of the then outstanding Series A preferred shares if we wish to
borrow money and at such time or as a result of such loans, the total
principal amount of our indebtedness and capitalized lease obligations
exceeds $15.0 million. As a result, we may be delayed in, or prohibited from,
obtaining certain types of financing.
See "Risk Factors- We may need additional capital and if we issue or
obtain additional financing, we may need the prior consent of the holders of our
Series A preferred shares."
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.
30
We have conducted a comprehensive examination of our information
technology systems and the software applications sold with our products to
determine year 2000 compliance. Based on our examination, we believe that these
systems and software applications are year 2000 compliant.
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
efforts at compliance accelerated the timetable for purchasing the system. We
believe that the costs to be incurred in reviewing our non-information
technology systems will be immaterial.
We have contacted our material customers, suppliers and third-party
service providers to identify year 2000 problems and provide solutions to
prevent any disruption of business activities. We completed a review of the
compliance efforts by these parties in the third quarter of 1999. Based on
the information we have received, our most significant year 2000 risk would
involve disruption of our material supply and distribution channels, and in
particular the supply of certain instrument parts and supplies from
single-source suppliers. This would likely lead to material interruption in
product development and sales of our products. In addition, we could
encounter significant expenses in remedying any problems or switching to year
2000 compliant vendors and suppliers. See "Risk Factors-We face risks
relating to year 2000 issues."
EURO CONVERSION
Effective January 1, 1999, 11 of the 15 member countries of the
European Union adopted the euro as their common legal currency and each
participant established fixed conversion rates between their sovereign, or
legacy, currencies and the common euro currency. The legacy currencies of the
individual countries are scheduled to remain legal tender as denominations of
the euro until January 1, 2002, when euro-denominated bills and coins will be
introduced. During this transition period, public and private parties may choose
to pay for goods and services using either the euro or the participating
country's legacy currency. By July 1, 2002, the legacy currencies will be phased
out entirely as legal tender.
We currently conduct business operations in U.S. and Canadian dollars
and several other currencies. Since our information systems and processes
generally accommodate multiple currencies, we anticipate that any necessary
modification to our information systems, equipment and processes to accommodate
euro transactions will be made on a timely basis and do not expect any failures
that would have a material adverse effect on our financial position or results
of operations.
31
INFORMATION ABOUT THE COMPANY
For a detailed description of our business and information about our
management, see our Annual Report on Form 20-F which is incorporated into this
prospectus by reference. The following information supplements or supercedes, as
may be appropriate, the information contained in our Annual Report on Form 20-F.
GENEKITS
We are no longer developing a GeneKit for human
papillomavirus. We feel our resources are better utilized by concentrating on
other GeneKits we are currently developing, such as hepatitis B, hepatitis C and
tuberculosis.
MANAGEMENT CHANGES
In July 1999, certain affiliated funds managed by E.M Warburg, Pincus &
Co., LLC, invested $30.0 million in our Company in exchange for 30,000 Series A
convertible preferred shares and warrants to purchase 1.1 million common shares
of our Company. Holders of our Series A preferred shares are entitled to vote as
a class for one director. Pursuant to that right, our Series A shareholders
appointed Jonathan S. Leff, a Vice President of E.M. Warburg, Pincus & Co., LLC
(see below for biography), as their representative to our Board of Directors.
Since Canadian law requires that a majority of our Board of Directors be
residents of Canada, Dr. Thomas C. Merigan, Jr. resigned as a director, thus
allowing our Company to remain in compliance with the law. Mr. Leff has filled
the position held by Dr. Merigan. Mr. Leff also serves on the Audit Committee
and the Compensation Committee of our Board of Directors. Mr. Leff, who is 31,
joined E.M. Warburg, Pincus & Co., LLC in July 1996 as an Associate, and in
January 1999, he became a Vice President. Mr. Leff is also a director of
VitalCom Inc., a provider of patient information networks and software, and a
number of private health care companies.
On November 10, 1999, Dr. John K. Stevens, our founder, and Chairman of
the Board of Directors retired from the Board. In accordance with the terms of
his employment agreement, Dr. Stevens will receive a severance package of 2
years salary plus benefits. We have extended the termination date of Dr.
Stevens' options until 2003. Upon retirement, Dr. Stevens repaid a $323,405 loan
owed to our company which was payable in 2006 and a $50,000 loan owed to our
company which was payable in December 1999.
In July 1999, Jeffrey D. Sherman, Vice President, Finance and Chief
Financial Officer, resigned from our company. A search firm has been retained to
identify a suitable candidate to fill the vacancy. Mr. Sherman has been
providing us with consulting services on an as required basis during the
transition period.
On November 10, 1999, Timothy W. Ellis was appointed Chief Operating
Officer for our company. In this role, he will be responsible in North America
for achieving overall business objectives, organizing and developing our sales
and marketing activities, and managing all manufacturing including instruments,
consumables and diagnostic kits. Mr. Ellis will be based in Atlanta, where our
wholly owned subsidiary, Applied Sciences, Inc. is currently located. We are in
the process of establishing a new 100,000 square foot facility in Atlanta that
will house its kit manufacturing operations, sales and marketing, and the
existing Applied Sciences, Inc.
operations.
Mr. Ellis has been involved in the diagnostics business for over 25
years, having held a variety of positions with a number of companies including
General Manager of Abbott Laboratories' Clinical Chemistry Business Unit,
President of Dynex Technologies, and President of Genetic Systems
32
Corporation. Mr. Ellis received Bachelor of Science and Master of Science
degrees from Bradley University.
On November 10, 1999, we agreed with Dr. Chalom Sayada, that Dr. Sayada
would no longer continue to serve as our Vice President for European Business
Development. However, Dr. Sayada will continue to provide marketing and strategy
consulting services to our company through May 2001 pursuant to a consulting
agreement.
On November 16, 1999, William C. Sullivan was appointed Vice
President, Diagnostic Manufacturing for our company. In this role, he will be
responsible for managing our kit manufacturing facility in Pittsburgh and
establishing a new manufacturing facility in Atlanta.
Mr. Sullivan has over 25 years of clinical laboratory in vitro
diagnostics experience. Most recently he served as Vice President, Operations
for Nichols Institute Diagnostics, a unit of Quest Diagnostics. Prior to
that, he held various positions at Laboratory Corporation of America, and its
predecessor company, Roche Biomedical Laboratories, Inc., Gen Trak, Inc. and
Geometric Data, then a subsidiary of Smithkline Beckman.
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 U.S. court in which the judgment were obtained had
a basis for jurisdiction in the matter. Our attorneys have also advised us that,
in their opinion, there is substantial doubt whether an action could be brought
successfully in Canada in the first instance on the basis of liability
predicated solely upon such laws.
33
SELLING SHAREHOLDERS
The following table provides certain information with respect to the
common shares issuable upon exercise of the warrants and/or conversion of the
Series A preferred shares held by each selling shareholder as of November 16,
1999. In consideration for a $30.0 million investment in our company, we
issued to the Warburg Pincus Funds 30,000 Series A preferred shares, and
warrants to purchase 1,100,000 common shares exercisable for four years at a
purchase price of $12.60 per share. In conjunction with the Warburg Pincus
financing, the Hilal Funds converted $3.9 million of debt plus accrued
interest into 3,948 Series A preferred shares and warrants to purchase
147,098 common shares exercisable for four years at a purchase price of
$12.60 per share. We granted the Warburg Pincus Funds and the Hilal Funds
certain registration rights, pursuant to which the common shares issuable
upon exercise of their warrants and conversion of their Series A preferred
shares are now being registered.
The Series A preferred shares are convertible to common shares at a
conversion price of $11.00 per share. Dividends accrue at the rate of 9% of the
liquidation value of the shares through July 15, 2002 and 4% of the liquidation
value until July 15, 2008. The liquidation value of the Warburg Pincus Funds'
Series A preferred shares is $30.0 million and the liquidation value of the
Hilal Funds' Series A preferred shares is $3.9 million. Dividends accrue
quarterly on the 15th day of January, April, July and October.
For purposes of the table below, the number of common shares offered
includes all common shares which a listed shareholder is entitled to receive
upon conversion of its Series A preferred shares plus accrued dividends on
those shares through October 15, 1999. The number of common shares which a
listed shareholder may receive upon conversion will increase as dividends
accrue, and therefore, the number of shares offered pursuant to this
prospectus will increase accordingly.
Although the table below includes shares which a holder of Series A
preferred shares is entitled to receive upon conversion as of October 15, 1999,
this prospectus (and the registration statement of which this prospectus is a
part) covers a total of 5,283,758 shares which includes all shares that
would be issued if all Series A preferred shares are converted by October 15,
2002. If any of the Series A preferred shares are converted sooner, then fewer
common shares would be issued. Similarly, if cash dividends were paid after
July 15, 2002 (the first date dividends may be paid), the cash dividends paid
would not be converted into common shares. However, we are required to give
the holders of Series A preferred shares notice and the opportunity to convert
their shares prior to the payment of any dividend. If cash dividends are not
paid and all of the Series A preferred shares are converted at a date after
October 15, 2002, then more common shares would be issued upon conversion.
In that case, we would be required to file an additional registration statement
covering the excess shares to be issued as a result of dividends accruing after
October 15, 2002. See "Description of Capital Shares."
Except as described in our Annual Report on Form 20-F 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 the common shares. Except as otherwise noted, all of the common shares
issuable upon exercise of the warrants and/or conversion of Series A preferred
shares 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 convert their Series A preferred shares or sell
all or any portion of their common shares, nor are the selling shareholders
obligated to sell any of their common shares immediately under this prospectus.
We will not receive any proceeds from any sales of common shares by the selling
shareholders.
34
Number of Common Shares
Common Offered Number of Percentage
Shares Owned Pursuant Common Shares Common Shares
BEFORE to this Owned After Owned After
SELLING SHAREHOLDER OFFERING(1) PROSPECTUS(2) OFFERING(3) OFFERING(9)
- ------------------- --------------- ------------ ----------- -------------
Warburg, Pincus Equity Partners, L.P. (4) 1,837,380 1,837,380 0 0
Warburg, Pincus Ventures International, L.P(4) 1,944,318 1,944,318 0 0
Warburg, Pincus Netherlands Equity Partners I, C.V. (4) 58,329 58,329 0 0
Warburg, Pincus Netherlands Equity Partners II, C.V. (4) 38,886 38,886 0 0
Warburg, Pincus Netherlands Equity Partners III, C.V. (4) 9,721 9,721 0 0
Hilal Capital, LP(5) 146,317(6) 74,362 71,955 *
Hilal Capital QP, LP(5) 381,408(7) 189,058 192,350 1.9%
Hilal Capital International, Ltd. (5) 491,185(8) 250,662 240,523 2.4%
- ------------------
* Less than 1%
(1) Includes shares issuable upon exercise of warrants and conversion of
Series A preferred shares.
(2) Assumes the exercise of all warrants issued and conversion of all
Series A preferred shares (including accrued interest at 9% per year)
outstanding at exercise prices in effect on October 29, 1999.
(3) Assuming all of the common shares offered by each selling shareholder
are sold in the offering.
(4) Jonathan S. Leff, a director of our Company, is also a Vice President
of E.M. Warburg, Pincus & Co., LLC, advisor to the funds.
(5) For the relationship of the Hilal funds to our company, see
"Management's Discussion and Analysis of Financial Condition and
Results of Operations-Liquidity and Capital Resources-INSTITUTIONAL
LOANS."
(6) In addition to the warrants issued in July 1999, includes warrants to
purchase 46,213 shares at a purchase price of $10.00 per shares and
warrants to purchase 11,284 shares at a purchase price of $17.00 per
share.
(7) In addition to the warrants issued in July 1999, includes warrants to
purchase 115,688 shares at a purchase price of $10.00 per shares and
warrants to purchase 28,683 shares at a purchase price of $17.00 per
share.
(8) In addition to the warrants issued in July 1999, includes warrants to
purchase 156,099 shares at a purchase price of $10.00 per shares and
warrants to purchase 38,033 shares at a purchase price of $17.00 per
share.
(9) Common shares issuable upon exercise of warrants and conversion of
Series A preferred shares are deemed outstanding for computing the
percentage ownership of the person holding the warrants and Series A
preferred shares but are not deemed outstanding for computing the
percentage ownership of any other person. This information is based
on 9,648,754 common shares outstanding on October 29, 1999.
35
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.
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.
The anti-manipulation provisions of Rules 101 through 104 under
Regulation M of the Securities Exchange Act of 1934 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 common shares by the selling shareholders to the
public, other than commissions or discounts of underwriters, broker-dealers or
agents.
36
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.
On July 15, 1999, our Board of Directors authorized the issuance of
33,950 shares of Series A Convertible Preferred Shares. The Series A preferred
shares are convertible at the holders' option into common shares at $11.00 per
share. The preferred shares contain provisions under which the conversion price
would be reduced on a weighted average basis if we issue shares, options or
certain other securities at prices lower than the conversion price (subject to
certain exceptions), and would also be adjusted upon the issuance of certain
other securities, certain recapitalization events and in certain other
circumstances to protect the holders against the dilutive effect of those
events.
Dividends on the preferred shares accrue quarterly at the rate of 9%
per year during the first three years after issuance, and 4% per year
thereafter and are compounded annually. Dividends will not be payable for the
first three years. After three years, at our option, we may pay dividends in
cash. If dividends are not paid in cash, they will continue to accrue and will
be convertible into additional common shares upon conversion of the preferred
shares.
After the third anniversary and prior to the seventh anniversary of the
date of issuance of the preferred shares, we would have the right to redeem the
outstanding preferred shares at a price, which we call the redemption price,
equal to $1,000 per share, plus accrued but unpaid dividends, provided that the
price of our common shares on the Nasdaq National Market equals or exceeds 150%
of the conversion price for 20 trading days during a consecutive 30-day period
ending within 10 days before we notify
37
shareholders of the redemption. We will be required to redeem one-third of any
remaining outstanding preferred shares on each of the seventh, eighth and ninth
anniversaries of the date of issuance at the redemption price, and we will be
permitted to redeem the preferred shares at any time beginning on the seventh
anniversary after issuance. If we fail to redeem the shares as required, holders
may appoint a majority of our Board of Directors, who will continue to serve
until we have redeemed the preferred shares as required.
The holders of Series A preferred shares will be entitled to vote as a
group with the holders of common shares on all matters except that holders of
Series A preferred shares will be entitled to vote separately for one director
and will not be entitled to participate in the vote for any other directors of
our company. Our agreements with the holders of Series A preferred shares
provide that we will be prohibited from declaring or issuing any dividends to
holders of our common shares before paying all unpaid dividends on the Series A
preferred shares. We will also be prohibited from issuing any equity securities
that are senior or equal in rank to the Series A preferred shares without
approval of the holders of a majority of the Series A preferred shares. If our
company were to be liquidated or sold or under certain other circumstances,
holders of Series A preferred shares would be entitled to receive an amount
equal to $1,000 per share, plus accrued dividends, before holders of our common
shares would be entitled to any distributions. Holders of Series A preferred
shares would also be entitled to certain other rights, including the right to
participate, on a pro rata basis, in future company financings, subject to
certain exceptions. We also are prohibited from incurring indebtedness for
borrowed money and capital lease obligations in excess of $15.0 million
outstanding at any one time, without first obtaining approval of the holders of
a majority of the Series A preferred shares. See "Risk Factors-We may need
additional capital and if we issue or obtain additional financing, we may need
the prior consent of the holders of our Series A preferred shares" and "Our
unlimited preferred shares, classified board of directors and Series A director
could prevent or delay takeovers and, our preferred shares contain preferences
over our common shares."
WARRANTS
On July 15, 1999, we issued 1,247,098 warrants to purchase our common
shares, see "Management's Discussion and Analysis of Financial Condition and
Results of Operations-Liquidity and Capital Resources." Each warrant is
exercisable for four years at an initial purchase price of $12.60, subject to
customary antidilution provisions. For a description of additional warrants
which we have issued, see "Management's Discussion and Analysis of Financial
Condition and Results of Operations-Liquidity and Capital Resources" and our
Annual Report on Form 20-F.
CLASSIFIED BOARD
Our Board of Directors is divided into three classes. The
classification of the Board of Directors was implemented in March 1996. See
"Risk Factors- Our unlimited preferred shares, classified board of directors and
Series A director could prevent or delay takeovers and, our preferred shares
contain preferences over our common shares."
The holders of our Series A preferred shares are entitled to vote as a
class for one director. Each Series A Director serves for a one year term and
any vacancy may be filled only by a vote of the holders of Series A preferred
shares. In the event that we do not redeem our Series A preferred shares as
required during 2006, 2007 and 2008, then our Series A shareholders will be
entitled to special voting rights enabling them to elect a majority of our Board
of Directors, who will continue to serve as directors until we have redeemed our
Series A preferred shares as required. See "Risk Factors- Our unlimited
preferred
38
shares, classified board of directors and Series A director could prevent or
delay takeovers and, our preferred shares contain preferences over our common
shares."
TRANSFER AGENT
The transfer agent and registrar for our common shares is ChaseMellon
Shareholder Services, LLC, Overpeck Center, 85 Challenger Road, Ridgefield Park,
New Jersey 07660.
39
LEGAL MATTERS
The validity of the common shares being offered hereby has been
passed upon for us by our attorneys, Goldman, Spring, Schwartz & Kichler,
Ontario, Canada. 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, New York, New York. 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., Washington, D.C. 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 100,040
common shares at various exercise prices.
EXPERTS
Our Consolidated Financial Statements as of December 31, 1997 and
1998 and for the years ended December 31, 1996, 1997 and 1998, included in
our Annual Report on Form 20-F, and incorporated herein by reference, have
been audited by PricewaterhouseCoopers LLP, Chartered Accountants in Canada,
as stated in their report appearing in our Annual Report on Form 20-F. The
Consolidated Financial Statements have been included herein in reliance upon
such report, given upon the authority of said firm as experts in auditing and
accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the Securities and Exchange Commission a
Registration Statement on Form F-3 under the Securities Act with respect to the
common 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 Securities and Exchange 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 or to our Annual
Report on Form 20-F, certain items of which are incorporated by reference into
this prospectus, 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.
We are subject to the informational requirements of the Exchange Act
and file reports and other information with the Securities and Exchange
Commission. Reports and other information which we file with the Securities and
Exchange 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 Securities and Exchange Commission at:
450 Fifth Street, N.W.
Room 1024
Washington, D.C. 20549
7 World Trade Center
New York, New York 10048
500 West Madison Street
Suite 1400
Chicago, Illinois 60661
You can also obtain copies of this material by mail from the Public
Reference Section of the Securities and Exchange Commission, 450 Fifth Street,
N.W., Washington, D.C. 20549, at prescribed rates. Additionally, copies of this
material may also be obtained from the Securities and Exchange Commission's
Internet site at http://www.sec.gov. The Commission's telephone number is
1-800-SEC-0330.
40
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5,283,758 SHARES
VISIBLE GENETICS INC.
COMMON SHARES
---------------------------
SELLING SHAREHOLDERS' PROSPECTUS
---------------------
, 1999
---------------------
YOU SHOULD RELY ONLY ON INFORMATION CONTAINED IN THIS PROSPECTUS. WE
HAVE NOT AUTHORIZED ANYONE TO PROVIDE YOU WITH INFORMATION DIFFERENT FROM THAT
CONTAINED IN THIS PROSPECTUS. THE SELLING SHAREHOLDERS ARE OFFERING TO SELL, AND
SEEKING OFFERS TO BUY, COMMON SHARES ONLY IN JURISDICTIONS WHERE OFFERS AND
SALES ARE PERMITTED. THE INFORMATION CONTAINED IN THIS PROSPECTUS IS ACCURATE
ONLY AS OF THE DATE OF THIS PROSPECTUS, REGARDLESS OF THE TIME OF DELIVERY OF
THIS PROSPECTUS OR OF ANY SALE OF OUR COMMON SHARES.
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.
Securities and Exchange Commission filing fee $27,450
Accounting fees $10,000
Legal fees $15,000
Printing and engraving..... $10,000
Miscellaneous $ 5,000
Total.... $67,450
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.
Jonathan S. Leff, one of our directors, is also indemnified pursuant to
venture fund partnership agreements, as well as supplemental coverage through
Warburg, Pincus & Co.
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.
II-1
ITEM 16. EXHIBITS
The following exhibits are being filed herewith:
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)
4.2 Certificate of Designations, Number, Voting Powers,
Preferences and Rights of Series A Convertible Preferred
shares of Visible Genetics Inc.
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.
(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
II-2
(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 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.
II-3
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 to be signed on its behalf by the undersigned, thereunto duly
authorized, in the City of Toronto, Province of Ontario, Canada, on the 17 day
of November 1999.
VISIBLE GENETICS INC.
By: /s/ Richard T. Daly
-------------------------------------
Richard T. Daly
President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Richard T. Daly and Samuel Schwartz or
any of them, as his true and lawful attorney-in-fact and agents, with full
powers of substitution and resubstitution, for him and in his name, place and
stead, in any and all capacities, to sign 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 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 or 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 said 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 below by the following persons in the
capacities and on the dates indicated.
SIGNATURE TITLE DATE
President and Chief
/s/ Richard T. Daly Executive Officer
_________________________ (principal executive officer
Richard T. Daly and principal financial November 17, 1999
officer)
II-4
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Richard T. Daly and Samuel Schwartz or
any of them, as his true and lawful attorney-in-fact and agents, with full
powers of substitution and resubstitution, for him and in his name, place and
stead, in any and all capacities, to sign 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 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 or 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 said 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 below by the following persons in the
capacities and on the dates indicated.
SIGNATURE TITLE DATE
/s/ Samuel Schwartz
- -------------------------------------
Samuel Schwartz Secretary and Director November 17, 1999
/s/ Michael A. Cardiff
- -------------------------------------
Michael A. Cardiff Director November 17, 1999
/s/ Sheldon Inwentash
- -------------------------------------
Sheldon Inwentash Director November 17, 1999
/s/ Jonathan S. Leff
- -------------------------------------
Jonathan S. Leff Director November 17, 1999
/s/ Dr. J. Robert S. Prichard
- -------------------------------------
Dr. J. Robert S. Prichard Director November 17, 1999
/s/ Dr. Lloyd M. Smith
- -------------------------------------
Dr. Lloyd M. Smith Director November 17, 1999
/s/ Dr. Konrad M. Weis
- -------------------------------------
Dr. Konrad M. Weis Director November 17, 1999
II-5
Authorized Representative in the United States:
/s/ Steven S. Pretsfelder
------------------------------------ November 17, 1999
Steven S. Pretsfelder
II-6
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT PAGE
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)
4.2 Certificate of Designations, Number, Voting Powers,
Preferences and Rights of Series A Convertible Preferred
shares of Visible Genetics Inc.
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.