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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
/ / Registration Statement Pursuant To Section 12(b) or 12(g) of The Securities
Exchange Act Of 1934
OR
/X/ Annual Report Pursuant To Section 13 or 15(d) of The Securities Exchange
Act of 1934 For the fiscal year ended December 31, 1999
OR
/ / Transition Report Pursuant To Section 13 or 15(d) of The Securities
Exchange Act Of 1934 For the transition period from to
COMMISSION FILE NUMBER 001-11145
BIOVAIL CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
NOT APPLICABLE
(TRANSLATION OF REGISTRANT'S NAME INTO ENGLISH)
PROVINCE OF ONTARIO, CANADA
(JURISDICTION OF INCORPORATION OR ORGANIZATION)
2488 DUNWIN DRIVE
MISSISSAUGA, ONTARIO
CANADA, L5L 1J9
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
TITLE OF EACH CLASS NAME OF EACH EXCHANGE ON WHICH REGISTERED
Common Shares, No Par Value New York Stock Exchange
Toronto Stock Exchange
Warrants, each warrant entitling New York Stock Exchange
the holder to purchase one Common Share,
no par value, of Biovail Corporation
6 3/4% Convertible Subordinated Preferred New York Stock Exchange
Equivalent Debentures due March 31, 2025
Securities registered or to be registered pursuant to Section 12(g) of the
Act: NONE
Securities for which there is a reporting obligation pursuant to Section 15(d)
of the Act: NONE
Indicate the number of outstanding shares of each of the issuer's classes of
capital or common stock as of the close of the period covered by the annual
report:
62,195,784 common shares, without par value as of December 31, 1999
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
Indicate by check mark which financial statement item the registrant has elected
to follow.
Item 17 X Item 18 ___
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TABLE OF CONTENTS
GENERAL INFORMATION
PART 1
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PAGE
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Item 1. Description of Business................................................................................2
Item 2. Description of Properties.............................................................................26
Item 3. Legal Proceedings.....................................................................................27
Item 4. Control of Registrant.................................................................................28
Item 5. Nature of Trading Market..............................................................................28
Item 6. Exchange Controls and Other Limitations
Affecting Security Holders..........................................................................30
Item 7. Taxation..............................................................................................31
Item 8. Selected Consolidated Financial Data..................................................................33
Item 9. Management's Discussion and Analysis of
Financial Conditions and Results of Operations......................................................35
Item 9A. Quantitative and Qualitative Disclosure about Market Risk.............................................41
Item 10. Directors and Officers of the Company.................................................................42
Item 11. Compensation of Directors and Officers................................................................44
Item 12. Options to Purchase Securities from the Company or Subsidiaries......................................46
Item 13. Interest of Management in Certain Transactions........................................................48
PART II
Item 14. (Not Applicable)......................................................................................49
PART III
Item 15. (Not Applicable).. ...................................................................................49
Item 16. Changes in Securities, Changes in Securities for Registered Securities and Use of
Proceeds .......................................................................................49
PART IV
Item 17. Financial Statements..................................................................................49
Item 18. Financial Statements..................................................................................50
Item 19. Financial Statements and Exhibits.....................................................................50
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PART I
All financial information contained in this document is expressed in United
States dollars, unless otherwise stated.
All share and related information(such as per share information, options and
warrants) has been adjusted to give effect, retroactively, to a two-for-one
stock split completed on December 31, 1999.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995:
TO THE EXTENT THAT ANY STATEMENTS MADE IN THIS DOCUMENT CONTAIN INFORMATION THAT
ARE NOT HISTORICAL, THESE STATEMENTS ARE ESSENTIALLY FORWARD LOOKING AND ARE
SUBJECT TO RISKS AND UNCERTAINTIES, INCLUDING THE DIFFICULTY OF PREDICTING U.S.
FOOD AND DRUG ADMINISTRATION AND CANADIAN THERAPEUTIC PRODUCT PROGRAM APPROVALS,
ACCEPTANCE AND DEMAND FOR NEW PHARMACEUTICAL PRODUCTS, THE IMPACT OF COMPETITIVE
PRODUCTS AND PRICING, NEW PRODUCT DEVELOPMENT AND LAUNCH, RELIANCE ON KEY
STRATEGIC ALLIANCES, AVAILABILITY OF RAW MATERIALS, THE REGULATORY ENVIRONMENT,
FLUCTUATIONS IN OPERATING RESULTS AND OTHER RISKS DETAILED FROM TIME TO TIME IN
THE COMPANY'S VARIOUS FILINGS WITH THE SECURITIES AND EXCHANGE COMMISSION.
ITEM 1. DESCRIPTION OF BUSINESS(1)
GENERAL
Biovail Corporation ("Biovail" or the "Company") is incorporated under
the Business Corporations Act (Ontario) R.S.O. 1990, as amended. Established on
March 29, 1994 as a result of the amalgamation of Trimel Corporation ("Trimel")
and its then subsidiary, Biovail Corporation International ("BCI"), the Company
effected an amalgamation on February 18, 2000 to change its name from Biovail
Corporation International to Biovail Corporation.
COMPANY OVERVIEW
OVERVIEW
We are an international, fully-integrated pharmaceutical company
specializing in the development of drugs utilizing advanced controlled-release,
rapid dissolve, enhanced absorption and taste masking technologies. We have
proprietary technologies which we use to develop products which are either (1)
generically equivalent to existing once-daily branded products or (2) branded
products that improve upon conventional multiple daily dose immediate-release
forms of existing products by providing the therapeutic benefits of
controlled-release drug delivery. As a fully-integrated company, we control all
facets of the drug development process from formulation development to clinical
testing, manufacturing and obtaining regulatory approval. This integrated
approach results in operational synergies, flexibility and cost efficiencies. In
Canada, we market our products directly, while in the rest of the world we
market our products through strategic licensing partners. We generate our
revenues from (1) developing and licensing oral controlled-release products
using our proprietary drug delivery technologies; (2) manufacturing such
products for sale to licensees and wholesalers and from direct marketing
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(1) BIOVAIL, the Biovail word logo, Tiazac-Registered Trademark-, Viazem, and
Crystaal are all trademarks of the Company which may be registered in Canada,
the United States and certain other jurisdictions. All other product names
referred to in this document are the property of their respective owners.
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of proprietary and in-licensed products in Canada; and (3) providing
pharmaceutical contract research services to Intelligent Polymers Limited
("Intelligent Polymers") and other third parties. We do not engage in basic
research to discover New Chemical Entities ("NCEs"). For the year ended
December 31, 1999, we had revenues of $176.5 million, net income of $62.5
million and earnings per share of $1.22. The three areas referred to in
clauses (1), (2) and (3) above accounted for 14.0%, 56.4% and 29.6%,
respectively, of our total revenues for the year.
In the past, we licensed our controlled-release products early in
the development cycle to pharmaceutical companies who developed, manufactured
and sold our products in a number of international markets. Today, we
develop, manufacture, market and out-license our own products once they have
reached an advanced state of development. We have developed fifteen products
to date that are currently sold under license in more than 55 countries. We
manufacture four of these products, Tiazac-Registered Trademark- and generic
versions of Trental, Cardizem CD and Voltaren XR, for sale by our licensees
in the United States and Europe. We also market a generic version of Verelan
through agreements with Mylan Pharmaceuticals Inc. ("Mylan") pending final
approval by the U.S. Food and Drug Administration ("the FDA") of our product.
In Canada, Tiazac-Registered Trademark- is sold by Crystaal, our marketing
division ("Crystaal"). Tiazac-Registered Trademark- is currently our
principal product, representing approximately 43.8% of revenues for the year
ended December 31, 1999.
Our pipeline products fall into two categories. The first category,
representing near-term opportunities, covers generic controlled-release and
rapid dissolve versions of fourteen major brand name drugs (one of which has
been tentatively approved), in particular, products indicated for the treatment
of chronic disorders such as cardiovascular and anti-arthritic conditions, and
for pain management. The second category, representing mid- to long-term
opportunities, are branded controlled-release once-daily versions of four
existing multi-dose products and one once-daily immediate-release product
(citalopram) indicated for the treatment of chronic disorders such as
depression, anxiety, smoking cessation, pain management and diabetes.
The following table lists our branded drugs and our generic versions of
branded drugs of others, each of which we currently license to others or market
or are developing:
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BRANDED GENERIC
VERSIONS OF
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Tiazac-Registered Trademark- Sirdalud CR Cardizem CD
Oruvail Gastro-Timelets Trental
MARKETED Norpace Novagent Verelan(1)
PRODUCTS Theo-24 Beta-Timelets Voltaren XR
Isoket Retard Tiamon Mono
Elantan Long Regenon Retard
UNDER DEVELOPMENT: APPROVED BY FDA:
PIPELINE Bupropion Adalat CC(3)
PRODUCTS Buspirone(2) FILED WITH FDA:
Metformin Verelan(1)
Tramadol
Citalopram Procardia XL(4)
Dilacor XR
UNDER DEVELOPMENT:
Controlled Release:
FOUR PRODUCTS
Rapid Dissolve:
SIX PRODUCTS
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(1) We are marketing Mylan's version of this product pending final regulatory
approval of our product. See "-Generic Product Pipeline-Generic Version of
Verelan."
(2) We recently initiated Phase III clinical trials for our controlled- release
formulation of buspirone.
(3) We have received tentative approval from the FDA for this product. See
"-Generic Product Pipeline-Generic Version of Adalat CC."
(4) We acquired this product from Intelligent Polymers in December 1999.
Three of the fourteen generic versions of branded controlled-release
and rapid dissolve drugs in our pipeline have been submitted and are awaiting
regulatory approval in the United States from the FDA. These three products
include generic formulations of Verelan, Procardia XL and Dilacor XR, all of
which are calcium channel blockers used for the treatment of hypertension and/or
angina. We have received tentative approval for a generic version of Adalat CC.
Historically, the FDA reviews and approves these generic products in an average
twenty-four month timeframe, unless the generic filer is subject to patent
infringement litigation by the innovator, in which case the FDA is precluded
from approving the product until the earlier of thirty months or settlement of
the patent infringement litigation. These four generic pipeline products
(including Adalat CC) had aggregate U.S. sales of approximately $1.1 billion
(including generics) for the twelve months ended September 30, 1999. Once
approved, these products will be marketed in the United States by Teva
Pharmaceutical Industries Ltd. (together with its affiliates, "Teva"). In
addition, we market a generic version of Verelan through our licensee Teva as a
result of our agreements with Mylan. Pursuant to this agreement, Mylan will
manufacture all of our requirements for Verelan until we receive product
approval from the FDA for our generic version of Verelan. See "-Generic Product
Pipeline-Generic Version of Verelan."
In July 1997, we formed Intelligent Polymers primarily to develop
once-daily controlled-release versions of selected drugs which are currently
marketed only in immediate-release form or in controlled-release form requiring
multiple daily dosing. The chemical patents and/or exclusivity periods for these
drugs have or will have expired upon the anticipated date of receipt of FDA
marketing approval for the once-daily controlled-release formulations to be
developed. We are developing certain products pursuant to contractual
arrangements with Intelligent Polymers. We will have the right to manufacture
and market such products, as licensee, under distinct brand names and not as
generics. In a $75 million initial public offering in October 1997, 100% of the
common shares of Intelligent Polymers were sold to the public. We own 100% of
the special shares of Intelligent Polymers, which allows us, at any time prior
to October 2002, to buy all, but not less than all, of Intelligent Polymers'
common shares from the public holders with cash, our stock, or a combination of
both. Intelligent Polymers does not perform any research or other activities on
its own behalf. We perform all such activities on behalf of Intelligent Polymers
under a development contract. See "Branded Product Pipeline-Development
Contract."
In December 1998, we entered into a multi-faceted ten-year agreement
with H. Lundbeck A/S of Copenhagen ("Lundbeck") for the development of a novel
controlled-release formulation of the anti-depressant citalopram, marketed under
the trademark Celexa in the United States. Under the agreement, we will develop,
manufacture and supply a controlled-release version of citalopram for commercial
sale by Lundbeck or its licensees worldwide. In exchange, Lundbeck will pay us
product development fees and an agreed upon supply price upon commercialization
of the controlled-release citalopram product.
Our marketing division, Crystaal, performs sales and marketing
activities in Canada for our products as well as for products licensed from
third parties. Crystaal is dedicated to providing
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high quality, cost effective branded pharmaceuticals to Canadian health care
professionals and their patients. Crystaal's product portfolio strategy is to
focus on drugs for the primary care market, therapies for the acute care
market and drugs for the treatment of central nervous system and neurological
disorders. All three areas represent rapidly growing market segments. We
believe our strategy of acquiring exclusive licenses from third parties to
sell branded drug products, combined with our portfolio of existing and
future controlled-release branded products, provides Crystaal with an
opportunity to become a significant marketing presence in the Canadian market.
We also have a full-service Contract Research Division ("CRD") which
provides clinical research and laboratory testing services for our product
development projects and for third-party international and domestic
pharmaceutical companies. The CRD includes a full-service bioanalytical
laboratory which performs specialized bioanalytical and quality control testing
and method development as well as other laboratory services. The CRD can also
provide support services to its clients in the area of quality control. The CRD
operates in a facility that includes a fully equipped bioanalytical laboratory,
a department of biopharmaceutics and statistical analysis and a live-in 200-bed
study clinic.
We intend to selectively pursue strategic investments and alliances
with small to medium-sized pharmaceutical companies that require additional
capital to sustain specific NCE projects in the advanced stages of development
as well as to fund the completion of development of novel products utilizing
advanced drug delivery systems. In exchange for our investments, we expect to
acquire various rights, options and licenses with respect to the manufacturing
and marketing of drugs and technologies derived from these projects.
INDUSTRY OVERVIEW
Controlled-release products are formulations which release bio-active
drug compounds in the body gradually and predictably over a 12 to 24 hour period
and which therefore only need to be taken once or twice daily.
Controlled-release products typically provide numerous benefits over
immediate-release drugs, including (1) greater effectiveness in the treatment of
chronic conditions resulting from a more consistent delivery of medication over
time; (2) reduced side effects; (3) greater convenience (only taken once or
twice a day); and (4) higher levels of patient compliance due to a simplified
dosing schedule. We believe that the total prescription drug market in the
United States was approximately $106 billion for the twelve months ended
September 30, 1999, while the oral controlled-release segment of this market was
approximately $7.9 billion for that period.
In general, pharmaceutical companies are under pressure to begin
marketing a drug as soon as it is developed in order to recoup significant
research costs and to secure early entry into the market. In addition, there are
significant technical barriers associated with the development of
controlled-release drugs. As a result, pharmaceutical companies typically have
not spent the time required to develop a controlled-release version of a product
while their immediate-release version is under patent, despite the therapeutic
advantages of controlled-release drugs versus their immediate-release
counterparts.
When a new drug product is developed, the innovator company typically
applies for and is granted a product patent which expires on the date which is
20 years from the first date a patent application was filed (or, for patents in
force on, or that result from a patent application filed before, June 8, 1995,
the later of such date and the date 17 years from the date a patent is issued).
Because no other company can, without authorization, make, use, sell, import or
offer for sale a generic version of such original branded product until the
chemical patent on such drug product expires, the innovator has a monopoly
during the patent period on marketing a branded product. Once the chemical
patent (and, if applicable, the exclusivity period) expires, other companies
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may be able to market a generic version of that branded product if no other
patents apply and regulatory approval is obtained.
If the generic product is bioequivalent to the reference product, it
can be substituted by pharmacists for the reference branded product prescribed
by physicians. Increasingly, pharmacists are substituting a branded product with
a generic because generic products are generally sold at a discount to the
corresponding branded product. Although discounted relative to branded products,
controlled-release generic products have not typically been subject to the deep
price discounts of immediate-release generics. Generic substitution is commonly
required by Managed Care Organizations ("MCOs"), Health Maintenance
Organizations ("HMOs") and other third-party payors.
Branded products that include the same chemical compound as the
original branded products, but are not generic versions of these brands, may
also be approved by the FDA. This approval is on the basis of the more extensive
regulatory procedures applicable to branded products. Once such products are
approved, they may be marketed as distinct brands in competition for doctors'
prescriptions against other brand name products upon expiration of the
applicable chemical patent on the drug compound used in the original branded
products, assuming the product does not violate any other patent. We believe
that there is a significant opportunity for the marketing of products approved
as branded once-daily controlled-release versions of products currently
available only in an immediate-release form (or in a controlled-release form
requiring multiple daily dosing) and whose patents or exclusivity period have or
will have expired upon the anticipated date of receipt of FDA marketing
approval. Excluding Procardia XL (which we acquired from Intelligent Polymers in
December 1999), the products we are developing on behalf of Intelligent Polymers
are of this sort.
There are approximately 60 oral controlled-release branded products
that have been approved for sale in the United States by the FDA. By the end of
2000, the patent and exclusivity periods will have expired on 95% of these
products. Because of the technological barriers associated with the development
of controlled-release drugs, there has not been the same proliferation of
generic drugs in the controlled-release segment as in the immediate-release
segment of the industry.
When an application for a new branded drug formulation (as opposed
to a generic) is approved by the FDA (A New Drug Application ("NDA")), it may
be granted a three-year exclusivity period under the Waxman-Hatch Act, during
which time it is protected from generic competition. For example,
Tiazac-Registered Trademark- was approved in September 1995 and its
exclusivity period expired in September 1998. One generic drug manufacturer
has submitted an application for a generic version of Tiazac-Registered
Trademark- with the FDA through an an Abbreviated New Drug Application
("ANDA"). We have commenced a legal action for patent infringement, which
automatically bars the FDA from granting approval for an additional 30
months, subject to earlier resolution of legal issues. Other than awaiting
the expiration of the Tiazac-Registered Trademark- patent and exclusivity,
the only way a generic applicant can avoid triggering the 30-month moratorium
is by not seeking approval as a generic equivalent of Tiazac-Registered
Trademark- through an ANDA, but by seeking approval as a branded drug by
filing an NDA under Section 505 (b)(1) of the Federal Food, Drug, and
Cosmetic Act (the "FDC Act"), which is more expensive and costly to prepare
than an ANDA.
Under the FDC Act, the first filer of a generic product is entitled to
receive 180 days of market exclusivity. Subsequent filers of generic products
would be entitled to market their approved product six months after the earlier
of the first commercial marketing of the first filer's generic product or a
successful defense of a patent infringement suit.
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PRODUCTS OF BIOVAIL
LICENSED AND MARKETED PRODUCTS
We have developed fifteen controlled-release drugs which are
currently marketed through licensees and, in the case of Tiazac-Registered
Trademark-, directly in Canada through our marketing division Crystaal. Of
these fifteen drugs, we manufacture four, Tiazac-Registered Trademark- and
generic formulations of Trental, Cardizem CD and Voltaren XR, under supply
agreements with our licensees. We also market one, Verelan, under agreements
with Mylan pursuant to which Mylan will manufacture all of our requirements
for Verelan until our version of the product is approved. See "-Generic
Product Pipeline-Generic Version of Verelan." The remaining drugs are
manufactured by licensees.
The following table sets forth the sixteen controlled-release
products (including Verelan) that are currently licensed and marketed. These
formulations have been designed for once-daily dosing unless otherwise
specified. Except for Tiazac-Registered Trademark-, which is our registered
trademark, the trade names for the pharmaceutical products described below
and elsewhere in this Form 20-F are the property of (and may be registered
trademarks of) our licensees and marketing partners or others.
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PRODUCTS CHEMICAL INDICATION PRINCIPAL LICENSEE
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MANUFACTURED BY BIOVAIL
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Tiazac-Registered Trademark- Diltiazem hypertension/angina Forest Laboratories, Inc ("Forest")
(U.S.), various international licensees
Trental (generic version) Pentoxifylline peripheral arterial Teva (U.S.)
disease
Cardizem CD (generic version) Diltiazem hypertension/angina Teva (U.S.)
Voltaren XR (generic version) Diclofenac osteoarthritis/rheumatoid Teva (U.S.)
arthritis
MANUFACTURED BY OTHERS
Oruvail Ketoprofen arthritis Wyeth-Ayerst Laboratories (U.S.)
Norpace(1) Disopyramide ventricular arrhythmias G.D. Searle (U.S.)
Theo-24 Theophylline asthma and bronchitis UCB Pharma (U.S.)
Isoket Retard Isosorbide Dinitrate angina Schwarz Pharma (Germany)
Elantan Long Isosorbide-5-Mononitrate angina Schwarz Pharma (Germany)
Sirdalud CR Tizanidine spasticity management Novartis (Switzerland)
Gastro-Timelets Metoclopramide gastric reflux Temmler (Germany)
Novagent Ibuprofen arthritis Temmler (Germany)
Beta-Timelets Propanolol hypertension/angina Temmler (Germany)
Tiamon Mono Dihydrocodeine pain management Temmler (Germany)
Regenon Retard Diethylpropion obesity therapy Temmler (Germany)
Verelan(2) (generic version) Verapamil hypertension/angina Teva (U.S.)
</TABLE>
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(1) Twice-daily dosing.
(2) Under agreement with Mylan, Mylan will manufacture all of our requirements
for Verelan until approval of our version of the product.
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TIAZAC-Registered Trademark-
Our principal product is currently Tiazac-Registered Trademark-,
accounting for approximately 43.8% of our total revenues for the year ended
December 31, 1999. No other product individually accounted for 10% or more of
our revenue base during such period. During this period, all revenue related
to Tiazac-Registered Trademark- was generated through our licensing
agreements with Forest and European licensees and sales made by Crystaal.
Tiazac-Registered Trademark- belongs to a class of drugs used in the
treatment of hypertension and angina called calcium channel blockers, which
generated U.S. sales of $3.9 billion for the twelve months ended September
30, 1999. Within the market for calcium channel blockers, diltiazem-related
once-daily products accounted for approximately $998 million of U.S. sales
for the twelve months ended September 30, 1999, the largest portions of which
are represented by Cardizem CD ($729 million, including generics) and Dilacor
XR ($115 million, including generics). Tiazac-Registered Trademark- is
another once-daily branded diltiazem product. Since we introduced
Tiazac-Registered Trademark- in the United States in February 1996,
Tiazac-Registered Trademark-'s market share has increased as a percentage of
total prescriptions in the U.S. once-daily diltiazem market, to approximately
16% by the end of 1999. There can be no assurance that such levels of growth
can be sustained.
Tiazac-Registered Trademark- has several advantages over other
formulations of diltiazem, including (1) a much smaller capsule size; (2) a
wider dosing range (approved for a maximum daily dose up to 540 mg); (3)
lower pricing; and (4) labeling which specifically permits physicians to
switch patients to Tiazac-Registered Trademark- from Cardizem CD at the
nearest equivalent daily dose. An NDA for Tiazac-Registered Trademark- was
approved by the FDA in September 1995 and by Health Canada's Therapeutic
Products Program ("TPP") in April 1997.
We licensed the right to market Tiazac-Registered Trademark- in the
United States to Forest in September 1995 and the formal product launch took
place in February 1996. Our license agreement with Forest provides us with a
royalty payment of 8% of net sales for 16 years, commencing December 1995. In
addition, under our 16-year supply agreement with Forest, we act as the
exclusive manufacturer of Tiazac-Registered Trademark- and receive
contractually determined manufacturing fees.
In Canada, Crystaal currently markets Tiazac-Registered Trademark-
through its field force consisting of over 70 representatives, under the
direction of a marketing and sales management team located at our
headquarters in Mississauga, Ontario, Canada. Tiazac-Registered Trademark-
has been accepted on the provincial drug formularies in each of the provinces
of Canada, thereby making it eligible for reimbursement by the provincial
government health plan in all provinces.
Tiazac-Registered Trademark- is marketed under the trade name Viazem
XL and under other trademarks in Europe. It is licensed to Stada Arzneimittel
AG ("Stada") in the United Kingdom and Ireland; Stada, Ratiopharm GmbH and
Heumann GmbH in Germany; Zambon B.V. in The Netherlands; A/S GEA Farmaceutisk
Fabrik in Denmark, Sweden and Finland and Crinos S.p.A. in Italy. We have
also licensed the product to two companies in South America and a company in
Australia.
PENTOXIFYLLINE
A three times a day timed-release formulation of pentoxifylline,
introduced in September 1994 by Hoechst Marion Roussel, is marketed in the
United States under the trade name Trental. Trental is used in the treatment of
patients with peripheral vascular disease. U.S. sales of Trental and generic
formulations of pentoxifylline were approximately $93 million in the twelve
months ended September 30, 1999. Competitors' generic versions of Trental were
launched in August 1997. We received approval of our generic version of Trental
in July 1998 and market this product in the United States through our licensee,
Teva.
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DILTIAZEM
A three to four times daily immediate-release formulation of
diltiazem, introduced in November 1982 by Hoechst Marion Roussel, is marketed
in the United States under the brand name Cardizem. Hoechst Marion Roussel
introduced a controlled-release once daily version in August 1992 under the
brand name Cardizem CD. U.S. sales of Cardizem CD were approximately $729
million (including generics) for the twelve months ended September 30, 1999.
We received approval of our generic version of Cardizem CD in December 1999
and we market this product in the United States through our licensee, Teva.
Tiazac-Registered Trademark-, although a once-daily diltiazem formulation, is
not a generic for Cardizem CD because it has a different release profile and
is marketed as a branded version of diltiazem, not as a generic for Cardizem
CD. As a result, we believe that our introduction of a generic for Cardizem
CD will not significantly impact Tiazac-Registered Trademark- sales, but will
instead erode sales of branded Cardizem CD.
DICLOFENAC
A two to three times daily delayed-release enteric coated
formulation of diclofenac, introduced in July 1988 by Ciba-Geigy Corporation,
is marketed in the United States under the brand name Voltaren. Ciba-Geigy
Corporation received approval from the FDA for a controlled-release version
and began marketing this product in April 1996 under the brand name Voltaren
XR. U.S. sales of Voltaren XR were approximately $98 million for the twelve
months ending September 30, 1999. Today the marketer of Voltaren XR is
Novartis Pharmaceuticals Corporation as a result of the Ciba-Geigy
Corporation/Sandoz Pharmaceuticals Corporation merger. We received approval
for our generic version of Voltaren XR in February 2000 and market this
product in the United States through our licensee, Teva.
OTHER BRANDED PRODUCTS
In addition to Tiazac-Registered Trademark-, we have formulated
eleven other branded oral controlled-release products. We have licensed these
products to marketing partners and receive royalties of approximately 3% of
the licensee's net sales of such products. This royalty rate reflects the
fact that these drugs were licensed before clinical trials had been completed
and, as a result, significant development risks were shared by the licensees.
The most significant product in this group is Oruvail, a
controlled-release formulation of ketoprofen used in the treatment of
rheumatoid arthritis and osteoarthritis, chronic conditions that we believe
affect an estimated 38 million people in the United States alone. Oruvail is
the world's first once-daily pH-dependent nonsteroidal anti-inflammatory
drug. Oruvail is internationally established as an effective anti-arthritic
treatment and is currently marketed by our licensees, Wyeth-Ayerst
Laboratories in the United States and Rhone-Poulenc Rorer in other countries.
In the United States, sales of Oruvail (including generics) were
approximately $64.4 million for the twelve months ended September 30, 1999.
Biovail's Oruvail, sold by Wyeth-Ayerst Laboratories, accounted for 61% or
$39.6 million of the total amount of Oruvail (including generics) sold in the
United States during that period.
GENERIC PRODUCT PIPELINE
We have a pipeline of fourteen generic versions of branded
controlled-release and rapid dissolve products, including Procardia XL, which
we acquired from Intelligent Polymers in December 1999. We have filed ANDAs
for four of our generic products with the FDA, one of which (Adalat CC) has
received tentative approval. Collectively, the branded versions of these four
products generated approximately $1.1 billion in U.S. sales in the twelve
months ended September 30, 1999.
9
<PAGE>
The eight controlled-release drugs in our generic product pipeline
are used primarily in the treatment of chronic conditions in the
cardiovascular and bone and joint disease areas and for pain management,
conditions for which controlled-release formulations provide significant
clinical and economic benefits.
We expect to price our generic products at a discount to branded
products. However, because of the technological barriers associated with
developing controlled-release products, we do not expect our generic products
to experience as much price erosion as immediate-release generic products,
which are easier to duplicate.
The following chart presents information for the twelve months ended
September 30, 1999 with respect to the branded versions of the four ANDAs
that we have filed with the FDA.
<TABLE>
<CAPTION>
TOTAL U.S. PRODUCT
CURRENTLY MARKETED BRAND NAME FILING DATE INDICATION SALES(IN MILLIONS)
----------------------------- ----------- ---------- -------------------
<S> <S> <S> <S>
Verelan(1) 1997 angina, hypertension $91(2)
Procardia XL(3) 1998 angina, hypertension 539
Adalat CC(4) 1998 hypertension 372
Dilacor XR 1998 angina, hypertension 115(2)
</TABLE>
- -----
(1) We are marketing this product under agreement with Mylan. See "-Generic
Version of Verelan."
(2) Includes generic versions.
(3) We acquired this product from Intelligent Polymers in December 1999.
(4) We have received tentative approval from the FDA for this product. See
"-Generic Version of Adalat CC."
GENERIC VERSION OF VERELAN
A three to four times daily immediate-release formulation of
verapamil, originally introduced in March 1982 by Knoll Pharmaceuticals, is
marketed in the United States. Lederle Laboratories received approval for a
controlled-release version in May 1990 and markets the product under the
brand name Verelan. U.S. sales of Verelan were approximately $91 million
(including generics) for the twelve months ended September 30, 1999.
We filed an ANDA for the generic version of Verelan in the second
quarter of 1997. In March 1999, we entered into agreements with Mylan for the
marketing of all dosages of a generic version of Verelan using our ANDA first
filer status and Mylan's product approval, which was granted on April 22,
1999. Mylan will manufacture all of our requirements for Verelan until our
product approval. We market this product through our licensee, Teva, and
Mylan independently markets and prices this product on its own behalf.
GENERIC VERSION OF PROCARDIA XL
A three to four times daily immediate-release formulation of
nifedipine, introduced in January 1982 by Pfizer Inc. ("Pfizer"), is marketed
in the United States under the brand name Procardia. Pfizer introduced a
controlled-release version in September 1989 under the brand name Procardia
XL. U.S. sales of Procardia XL were approximately $539 million for the twelve
months ended September 30, 1999.
10
<PAGE>
We developed our generic version of Procardia XL on behalf of
Intelligent Polymers that includes multiple strengths and filed an ANDA in
the first quarter of 1998. Prior to such filing, Mylan filed an ANDA for the
30 mg. strength only. In December 1999, we exercised an option to acquire
this product from Intelligent Polymers by paying $25.0 million.
GENERIC VERSION OF ADALAT CC
A three to four times daily immediate-release formulation of
nifedipine, introduced in January 1985 by Bayer, is marketed in the United
States under the brand name Adalat. Bayer received approval from the FDA for
a controlled-release version in April 1993 and markets the product under the
brand name Adalat CC. U.S. sales of Adalat CC were approximately $372 million
for the twelve months ended September 30, 1999.
We received tentative approval from the FDA in June 1999 for our 30
mg. and 60 mg. generic versions of Adalat CC. Tentative approval means that
the scientific aspects of the product have been approved by the FDA. We were
the first company to file an ANDA for the 60 mg. strength of Adalat CC and
will therefore be entitled to 180 days of marketing exclusivity. Elan
Corporation plc ("Elan") was the first to file an ANDA for the 30 mg.
strength. We have entered into an agreement with Elan giving us exclusive
marketing rights for the United States for Elan's generic versions of Adalat
CC in return for certain upfront payments and future royalties. We will thus
be able to launch a 30 mg. Adalat CC product, which we intend to do through
Teva, six months earlier than previously scheduled.
GENERIC VERSION OF DILACOR XR
A once daily controlled-release formulation of diltiazem, introduced
in June 1992 by Rhone-Poulenc Rorer, Inc., is marketed in the U.S. by Watson
Pharmaceuticals, Inc. under the brand name Dilacor XR. U.S. sales of Dilacor
XR were approximately $115 million (including generics) for the twelve months
ended September 30, 1999.
We filed an ANDA for the generic version of Dilacor XR in the third
quarter of 1998.
BRANDED PRODUCT PIPELINE
In July 1997, we formed Intelligent Polymers primarily to develop
once-daily controlled-release branded versions of selected drugs whose
chemical patents and/or exclusivity periods have or are about to expire and
which are currently marketed (1) only in immediate-release form or (2) in
controlled-release form requiring multiple daily dosing. We expect that such
products will be marketed under distinct brand names. In an initial public
offering in October 1997, 100% of the common shares of Intelligent Polymers
were sold to the public. At any time prior to October 2002, as the holder of
a class of special shares of Intelligent Polymers, we have the right to buy
from the public holders all, but not less than all, of Intelligent Polymers'
common shares with cash, our stock or a combination of both. Intelligent
Polymers does not perform any research or other activities on its own behalf,
but rather contracts with us to perform all such activities pursuant to the
terms of the Development Contract (as defined below).
In December 1998, we entered into a multi-faceted ten-year agreement
with Lundbeck for the development of a novel controlled-release formulation
of the anti-depressant citalopram, marketed under the trademark Celexa in the
United States. Under the agreement, we will develop, manufacture and supply a
controlled-release version of citalopram for commercial sale by Lundbeck or
its licensees worldwide. In exchange, Lundbeck will pay us product
development fees and an agreed upon supply price upon commercialization of
the controlled-release citalopram product.
11
<PAGE>
We are working to develop once-daily controlled-release branded
versions of the following compounds which had aggregate U.S. sales of
approximately $2.9 billion for the twelve months ended September 30, 1999.
<TABLE>
<CAPTION>
CURRENTLY MARKETED TOTAL U.S. PRODUCT
COMPOUND BRAND NAME U.S. MARKETER INDICATION SALES(IN MILLIONS)
-------- ------------------ ------------- ----------- -----------------
<S> <C> <C> <C> <C>
Bupropion Wellbutrin/Zyban Glaxo Wellcome depression, smoking cessation $700
Buspirone Buspar Bristol-Myers Squibb anxiety, depression 512
Metformin Glucophage Bristol-Myers Squibb diabetes 978
Tramadol Ultram Johnson & Johnson chronic pain 434
Citalopram Celexa Forest depression 239(1)
</TABLE>
- ------
(1) Product sales from October 1998 (when the product was launched in the
United States) to September 30, 1999.
BUPROPION
A four times daily immediate-release formulation of bupropion,
introduced in July 1989 by Glaxo is marketed in the United States under the
brand name Wellbutrin. In addition, a twice-daily controlled-release
formulation of bupropion, introduced in November 1996 by Glaxo, is marketed
in the U.S. under the brand name Zyban for use as an aid in smoking
cessation. U.S. sales of Wellbutrin/Zyban were approximately $700 million for
the twelve months ended September 30, 1999.
INDICATION: Bupropion is indicated for the symptomatic relief of depressive
illness. Major depression is frequently encountered by patients of primary
care physicians. Depression may occur in neurosis as well as in mood
disorders and is a manifestation of major psychiatric illness. Bupropion is
also indicated in the United States for use as an aid in smoking cessation.
CLINICAL EFFICACY: Bupropion has been proved to be effective in the treatment
of depression. An open, uncontrolled study of 3,167 patients at 105 sites
showed that functional status improved in patients treated with Wellbutrin SR
for up to 56 days. This improvement was highly correlated with improvement in
clinical symptoms.
Bupropion can also be used in conjunction with other anti-depressant
drugs. When combined with another class of anti-depressants, specified
neurotransmitter modulators ("SNMs"), in 27 patients, greater symptomatic
improvement was found in 19 (70%) of those 27 subjects during a combined
daily use of bupropion with an SNM (Prozac-equivalent) than with either drug
alone.
Intelligent Polymers' once-daily controlled-release formulation of
bupropion seeks to significantly improve upon the existing sustained release
formulation by providing sustained plasma levels with better control of
symptoms and improved compliance with convenient once-a-day dosing.
Clinically, it is important that symptoms in the depressed patient be
adequately controlled as compliance is a major concern in these patients.
In a study with children with attention deficit disorder with
hyperactivity ("ADDH"), the results indicated that bupropion may also be a
useful addition to available treatments for ADDH.
12
<PAGE>
In addition, bupropion has been demonstrated to be an effective aid
in smoking cessation. In a placebo-controlled trial comparing transdermal
nicotine, and sustained-release bupropion, and a combination of both
transdermal nicotine and sustained-release bupropion in 893 patients for nine
weeks, smoking cessation rates were 20% with placebo, 32% with nicotine
alone, 46% with bupropion alone and 51% with both transdermal nicotine and
bupropion.
MARKET SIZE: The largest segment in the anti-depressant market is represented
by SNMs (with which Bupropion is used in combination or with which it
competes) which had U.S. sales of approximately $5.9 billion for the twelve
months ended September 30, 1999. The anti-depressant market consists of four
major drug categories: tricyclic anti-depressants, monoamine oxidase
inhibitors, anti-mania drugs and SNMs. Major marketed brands include Tofranil
(imipramine), Prozac (fluoxetine), Paxil (paroxetine), Luvox (fluoxamine) and
Zoloft (sertaline). The smoking cessation market reached $396 million for the
twelve months ended September 30, 1999. Major marketed brands of smoking
cessation products include nicotine products such as Nicoderm, Habitrol,
Nicorette, Nicotrol and Prostep.
BUSPIRONE
A three times daily immediate-release formulation of buspirone,
introduced in October 1986 by Bristol-Myers Squibb Company, is marketed in
the United States under the brand name Buspar. U.S. sales of Buspar were
approximately $512 million for the twelve months ended September 30, 1999. We
recently initiated Phase III clinical trials for our controlled-release
formulation of buspirone.
INDICATION: Buspirone is indicated for the short-term symptomatic relief of
excessive anxiety in patients with generalized anxiety disorder ("GAD"),
which is also known as anxiety neurosis. GAD is a neurotic disorder
characterized by chronic unrealistic anxiety often punctuated by acute
attacks of anxiety or panic. Anxiety is a symptom of almost all psychiatric
disorders and is encountered in day-to-day practice by both the general
practitioner and the psychiatrist.
CLINICAL EFFICACY: Controlled studies suggest that buspirone is effective in
treating GAD and that, unlike other anti-anxiety drugs, tolerance to the
therapeutic effect of buspirone does not develop. In one study involving 121
patients, buspirone was found to be effective in improving both anxiety and
depressive symptoms in GAD patients. Another study showed that buspirone was
more effective and had fewer side effects than lorazepam, a competing drug,
and that, unlike patients treated with lorazepam, those treated with
buspirone did not exhibit rebound anxiety. Given its effectiveness in
treating symptoms of depression associated with GAD, buspirone is also an
effective and well tolerated drug for the treatment of depressive disorders.
MARKET SIZE: The anti-anxiety market had approximately $1.2 billion in U.S.
sales for the twelve months ended September 30, 1999, of which buspirone was
the market leader. Due to its efficacy in treating depressive symptoms in GAD
patients, Buspirone also indirectly competes in the market for antidepressant
drugs, including the market for SSRIs and SNRIs, which represented U.S. sales
of approximately $5.9 billion for the twelve months ended September 30, 1999.
Major anti-anxiety brands other than Buspar include Xanax (alprazolam),
Librium (chlordiazepoxide), Valium (diazepam), Ativan (lorazepam), Serax
(oxazepam) and Atarax (hydroxyzine).
METFORMIN
A two to three times daily immediate-release formulation of
metformin, introduced in April 1995 by Bristol-Myers Squibb Company, is
marketed in the United States under the brand name Glucophage. U.S. sales of
Glucophage were approximately $978 million for the twelve months ended
September 30, 1999.
13
<PAGE>
INDICATION: Metformin is indicated for the treatment of diabetes mellitus
which cannot be controlled by proper dietary management, exercise and weight
reduction or when insulin therapy is not appropriate. Diabetes is a common
disorder in which there are inappropriately elevated blood glucose levels and
a variety of end organ complications leading to impaired kidney function and
accelerated atherosclerosis.
CLINICAL EFFICACY: Clinical advantages of metformin include achieving control
of elevated blood sugar levels without exacerbating weight gain, which is a
common side effect of other anti-diabetic treatments. Metformin differs from
the sulfonylureas in that it does not elevate insulin secretion and does not
produce abnormally low blood sugar levels.
In controlled trials, metformin has shown efficacy in lowering
elevated blood sugar levels in the treatment of diabetes mellitus. In one
such study of 289 obese patients with non-insulin dependent diabetes, poorly
controlled with diet, the patients were given metformin or a placebo. Blood
sugar levels were on average 29% lower in patients receiving metformin than
in patients receiving a placebo. Furthermore, total cholesterol, LDL, and
triglyceride concentrations decreased in patients receiving metformin, but
did not change in patients receiving a placebo.
MARKET SIZE: The oral anti-diabetic market represented approximately $2.4
billion in U.S. sales for the twelve months ended September 30, 1999. Major
anti-diabetic products other than Glucophage include Glucotrol XL (glipizide)
and Glynase (glyburide).
TRAMADOL
A three to four times daily immediate-release formulation of
tramadol, introduced in March 1995 by Johnson and Johnson, is marketed in the
United States under the brand name Ultram. U.S. sales of Ultram were
approximately $434 million for the twelve months ended September 30, 1999.
INDICATION: Tramadol is indicated for the treatment of a variety of pain
syndromes, including management of moderate to moderately severe chronic pain
associated with cancer and other terminal illnesses. Pain is a common symptom
of many diseases and is generally seen in everyday clinical practice.
CLINICAL EFFICACY: Tramadol is one of a number of narcotic (opioid)
analgesics, which are among the most effective and valuable medications for
the treatment of chronic pain. Tramadol's minimal propensity to induce
typical opioid adverse effects is an advantage over other morphine-like
agents. For example, relative to Morphine, tramadol causes less dependence
and less respiratory depression. Tramadol also appears to be a promising drug
for post-operative pain relief.
In an article published in the American Journal of Medicine, the
author concluded that, based on clinical experience, tramadol appears to have
a low potential for abuse or addiction. Results from U.S. and European
studies indicated that tramadol is an effective analgesic that may have a
particularly important role in the management of chronic pain. Tramadol has
been prescribed for almost two decades in Europe.
Two long-term safety studies conducted on patients with chronic,
nonmalignant pain demonstrated the efficacy of tramadol in a variety of pain
conditions.
Intelligent Polymers' once-daily controlled-release formulation of
Tramadol seeks to provide sustained pain control, as compared to the
immediate-release form. This would be especially useful to cancer or
terminally ill patients who need analgesics as a 24-hour treatment.
14
<PAGE>
MARKET SIZE: The combined market for narcotic and non-narcotic analgesics had
U.S. sales of $2.3 billion for the twelve months ended September 30, 1999.
The market for drugs for the relief of chronic pain consists of two major
categories, narcotic and non-narcotic drugs.
CITALOPRAM
An immediate-release formulation of the anti-depressant citalopram
was launched in the United States in October 1998 and is marketed under the
trademark Celexa in the United States by Forest. U.S. sales of Celexa were
approximately $239 million for the eleven months ended September 30, 1999.
INDICATION: Citalopram is indicated for the treatment of depression, which is
frequently encountered by patients of primary care physicians. Depression may
occur in neurosis as well as in mood disorders and is a manifestation of
major psychiatric illness.
CLINICAL EFFICACY: Citalopram has been proved to be effective in the
treatment of depression. Citalopram belongs to a class of drugs known as
SSRIs. Clinical studies have shown that compared to many other SSRIs,
citalopram has an improved side effect profile and a lower incidence of drug
interactions when taken concurrently with other medications.
MARKET SIZE: Sales for the drug treatment of depression in the United States
were $7.2 billion for the twelve months ended September 30, 1999. Citalopram
sales accounted for 3.3% of this market. Citalopram is marketed under the
names Cipramil and Seropram outside of the United States.
DEVELOPMENT CONTRACT
We have entered into a development and license agreement with
Intelligent Polymers (the "Development Contract") under which we have agreed
to use diligent efforts to conduct toxicity, formulation development and
clinical studies for, and pursue U.S. regulatory approval of, the branded
products described above (other than citalopram). We consider the pricing
structure of the Development Contract to be consistent with contractual
relationships we have with other third parties and with industry standards.
Payments to us under the Development Contract are in an amount equal
to the full amount of all development costs incurred by us in performing
these activities plus a mark-up. Payments under the Development Contract will
be limited to the maximum amount of funds available to Intelligent Polymers
(which includes any licensing or marketing income earned by Intelligent
Polymers and the $25.0 million received from the exercise of our option to
purchase the generic version of Procardia XL). These payments will be reduced
by working capital of $1.0 million to be retained by Intelligent Polymers and
a reserve of $1.5 million for possible litigation relating to the generic
version of Procardia XL (including any portion of the litigation reserve
remaining after FDA approval of such product). All funds required to fund the
development of these products were raised in the $75.0 million initial public
offering of Intelligent Polymers' common shares in October 1997.
We will own all rights to the products which we develop for
Intelligent Polymers pursuant to the Development Contract. We will cause to
be filed any patent applications with respect to the products that we
reasonably believe to be patentable and technically significant. Although our
patents, pending patent applications, and any patents obtained in the future
covering such products developed on behalf of Intelligent Polymers may be of
importance to future operations, there can be no assurance that any
additional patents will be issued or that any patents, now or hereafter
issued, will be of commercial benefit. Furthermore, although we will own any
patents granted, these patents will be subject to Intelligent Polymers'
license (the "License") to
15
<PAGE>
manufacture or obtain manufacturing for (subject to our exclusive
manufacturing period, right of first refusal and right of approval), sell and
otherwise market and sublicense others to market throughout the world (other
than in Canada) all products developed by us on behalf of Intelligent
Polymers. The License will also apply to products developed under other
arrangements if we fail to reach agreement as to any necessary additional
funding.
PURCHASE OPTION
As the holder of all of the issued and outstanding special shares,
par value $1.00 per share, of Intelligent Polymers, we have the right to
purchase until September 30, 2002 all, but not less than all, of the common
shares of Intelligent Polymers outstanding at the time our right is exercised
(the "Purchase Option"). If the Purchase Option is exercised, the purchase
price in the aggregate would be as follows:
<TABLE>
<CAPTION>
EXPECTED
IF THE INTELLIGENT POLYMERS COMMON SHARES ARE PURCHASE OPTION
ACQUIRED PURSUANT TO THE PURCHASE OPTION: EXERCISE PRICE PRICE PER SHARE
--------------------------------------------- --------------- ---------------
<S> <C> <C>
(IN MILLIONS)
Before October 1, 2000 $146.0 $39.06
On or after October 1, 2000 and on or before September 30, 2001 182.5 48.83
On or after October 1, 2001 and on or before September 30, 2002 228.1 61.04
</TABLE>
Subject to obtaining any necessary regulatory approvals, the
Purchase Option exercise price may be paid in cash or in our common shares,
or any combination of cash and our common shares, in our sole discretion. Our
common shares will be valued based upon the average of the closing prices for
our common shares on the New York Stock Exchange ("NYSE") for the five
trading days immediately preceding the date of the exercise notice.
SERVICES AGREEMENT
We have also entered into a services agreement (the "Services
Agreement") with Intelligent Polymers pursuant to which we have agreed to
provide management and administrative services to Intelligent Polymers for a
quarterly fee of $100,000. The Services Agreement terminates one year after
termination of the Purchase Option. In addition, Intelligent Polymers may
terminate the Services Agreement at any time upon 90 days' notice. Either we
or Intelligent Polymers may terminate the Services Agreement in the event
that the other party (1) breaches any material obligation thereunder or under
the Development Contract, which breach continues for 60 days after notice
thereof, or (2) enters into any liquidation or bankruptcy proceedings.
MARKETING
Outside of Canada, we do not engage in direct marketing or sales of
our products. Instead, we seek to enter into strategic licensing agreements
with various regional and multinational pharmaceutical companies for the
marketing and sale of our products in specified territories. While the
specific terms of each license agreement vary, the agreements in general
require the licensee to (1) purchase the product from us, (2) pay us a
royalty fee based on a specific percentage of net sales and/or a share of the
net profits from sales of the licensed products and (3) in certain
circumstances pay a license fee for access to our technologies.
FOREST LABORATORIES
We licensed the right to market Tiazac-Registered Trademark- in the
United States to Forest in September 1995 and the formal product launch took
place in February 1996. The license agreement with Forest provides for a
royalty payment of 8% of its net sales of Tiazac-Registered Trademark- for a
period of 16 years,
16
<PAGE>
commencing December 1995. In addition, under a 16-year supply agreement which
also commenced December 1995, we act as the exclusive manufacturer of
Tiazac-Registered Trademark- for Forest and receive contractually determined
manufacturing fees.
TEVA PHARMACEUTICAL
In December 1997, we entered into an agreement with Teva for the
development and marketing in the United States of eight identified and four
to-be-identified generic oral controlled-release products. See "-Generic
Product Pipeline." Of the eight identified products, generic versions of
Trental, Cardizem CD and Voltaren XR have been approved by the FDA and ANDAs
for four others have been filed with the FDA, including Adalat CC, for which
we received tentative approval in June 1999. We will manufacture the products
covered by this agreement and will share the profits, after deducting
manufacturing costs and an allowance for selling and distribution expenses
incurred by Teva.
We bear all costs and expenses for the development and registration
of the eight identified products. Under the terms of the agreement, Teva was
obligated to pay us an aggregate of $34.5 million, subject to certain
milestones. Of the $34.5 million, $23.5 million related to reimbursement of
research and development fees and $11.0 million related to the initial
purchase of product, all of which have been earned and received.
INTERNATIONAL MARKETING ALLIANCES
Tiazac-Registered Trademark- is marketed under the trade name Viazem
XL and under other trademarks in Europe. It is licensed to Stada in the
United Kingdom and Ireland; Stada, Ratiopharm GmbH and Heumann GmbH in
Germany; Zambon B.V. in The Netherlands; A/S GEA Farmaceutisk Fabrik in
Denmark, Sweden and Finland and Crinos S.p.A. in Italy. We have also licensed
the product to two companies in South America and a company in Australia.
In Canada, we have licensed exclusively the generic version of
Cardizem CD to Novopharm Limited, and have licensed the generic versions of
Trental, Verelan, Adalat XL and Cardizem SR to Technilab Pharma Inc.
CRYSTAAL
Crystaal, our Canadian marketing and sales division, performs sales
and marketing activities for our products as well as for products licensed
from third parties worldwide. Crystaal is located at our headquarters in
Mississauga, Ontario, Canada. Crystaal is dedicated to providing high
quality, cost effective branded pharmaceuticals to Canadian health care
professionals and their patients.
Crystaal has adopted a business strategy of acquiring licenses of
third parties to sell branded drug products through strategic joint ventures
and partnerships. We believe that this strategy, combined with our portfolio
of existing and new controlled-release branded products, places Crystaal in
an excellent position to become a significant marketing presence in the
Canadian market. Crystaal is the largest independent supplier of branded
pharmaceutical products in Canada. Its competitors are other independent
suppliers and divisions of large multinational pharmaceutical companies.
Crystaal's product portfolio strategy is to focus on drugs for the
primary care market, therapies for the acute care market and drugs for the
treatment of central nervous system and neurological disorders. All three
therapeutic areas represent rapidly growing market segments, offering a
multitude of opportunities for acquiring third party licenses.
17
<PAGE>
The following table reflects products currently in Crystaal's
portfolio and pipeline and the status of their respective new drug submission
("NDS") filings in Canada:
<TABLE>
<CAPTION>
PRODUCT INDICATION STATUS
------- ---------- ------
<S> <C> <C>
Retavase(TM)(reteplase recombinant) acute myocardial infarction Approved and marketed
Cardiac STATus(TM) diagnosis of myocardial infarction Approved and marketed
Brexidol (b-cyclodextrin complex) acute pain Approved and marketed
Celexa (citalopram) depression Approved and marketed
Tiazac-Registered Trademark-
(diltiazem CR) hypertension, angina Approved and marketed
Monocor (bisoprolol fumarate) hypertension To be marketed in Q2 2000
Attenade (d-methylphenidate) Attention Deficit-Hyperactivity Disorder (ADDH) NDS expected to be filed
in Q4 2000
Corlopam (fenoldopam) hypertension in hospitalized patients NDS filed
Fibrostat(TM) treatment of scars following surgery and burns NDS expected to be filed
in late 2001
Ampligen-Registered Trademark- Chronic Fatigue Syndrome (CFS) NDS expected to be filed
in Q4 2000
</TABLE>
Crystaal co-promotes the immediate-release version of Celexa in
collaboration with Lundbeck Canada Inc. Crystaal promotes Celexa to primary
care physicians and will receive co-promotion fees for contributing to the
marketing of Celexa in Canada.
In Canada, Crystaal markets Tiazac-Registered Trademark- through its
field force consisting of over 70 representatives. Tiazac-Registered
Trademark- has been accepted on the provincial drug formularies in each of
the provinces of Canada, thereby making it eligible for reimbursement by the
provincial government health plan in all provinces.
TECHNOLOGY
We have six proprietary drug delivery technologies which we use to
develop controlled-release and rapid dissolve products. These technologies
enable us to develop both branded and generic pharmaceutical products. Our
formulations for these products are either patented or proprietary.
Accordingly, other generic manufacturers may be inhibited from duplicating
products because of our patented or proprietary rights or because of the
difficulty of duplicating our formulations.
Oral controlled-release technology permits the development of
specialized oral drug delivery systems that improve the absorption and
utilization by the human body of a variety of pharmaceutical compounds.
Release patterns are characterized as zero order, which indicates constant
release over time, or first order, which indicates decreasing release over
time. These systems offer a number of advantages, in particular, allowing the
patient to take only one or two doses a day. This, combined with enhanced
therapeutic effectiveness, reduced side effects, improved compliance and
potential cost effectiveness, makes controlled-release drugs ideally suited
for the treatment of chronic conditions.
Our controlled-release technologies can provide a broad range of
release profiles, taking into account the physical and chemical
characteristics of a drug product, the therapeutic use of the particular drug
and the optimal site for release of the basic drug in the gastrointestinal
tract (the "GI tract"). The objective is to provide a delivery system
allowing for a single dose per 12 to 24 hour period, while assuring gradual
and controlled- release of the subject drug at a suitable location(s) in the
GI tract.
Our rapid dissolve formulations contain the same basic chemical
compound found in the original branded products. The dry compounds are
encapsulated in microspheres utilizing our
18
<PAGE>
CEFORM-Registered Trademark- technology. Our Shearform-Registered Trademark-
technology is used to produce matrices that are subsequently processed into
amorphous fibers which, when blended with the CEFORM-Registered Trademark-
microspheres, are compressed into rapid dissolve formulations including Flash
Dose-Registered Trademark- tablets. The benefits of rapid dissolve
formulations include the ease of administration for the elderly, young
children or people with disease states who may have difficulty swallowing
tablets or capsules.
We use six proprietary drug delivery platforms, described below,
involving matrix tablets or multiparticulate beads in capsules. These
platforms are capable of delivering a wide variety of drug compounds in
controlled-release and rapid dissolve oral dosage formulations.
DIMATRIX
Dimatrix is a diffusion controlled matrix technology for water
soluble drugs in the form of tablets. The drug compound is uniformly
dispersed in a polymer matrix. The mechanism of release involves the swelling
of polymers within the matrix, thus enabling the drug to be dissolved and
released by diffusion through an unstirred boundary layer. The release
pattern is characterized as first order as the rate of drug diffusion out of
the swollen matrix is dependent upon the concentration gradient.
MACROCAP
Macrocap consists of immediate-release beads made by extrusion /
spheronization / pelletization techniques or by layering powders or solutions
on nonpareil seeds. Release modulating polymers are sprayed on the beads
using various coating techniques. The coated beads are filled in hard gelatin
capsules. Drug release occurs by diffusion associated with bioerosion or by
osmosis via the surface membrane. The release mechanism can be pH activated
or pH independent. The beads can be formulated to produce first order or zero
order release.
CONSURF
Consurf is a zero order drug delivery system for hydrophilic and
hydrophobic drugs in the form of matrix tablets. The drug compound is
uniformly dispersed in a matrix consisting of a unique blend of polymers. The
mechanism of release involves the concurrent swelling and erosion of the
matrix such that a constant surface matrix area is maintained during transit
through the GI tract, resulting in zero order release.
MULTIPART
Multipart consists of a tablet carrier for the delivery of
controlled-release beads which preserves the integrity and release properties
of the beads. The distribution of the beads is triggered by disintegration of
the tablet carrier in the stomach. Drug release from the beads can be pH
activated or pH independent and can occur by disintegration or osmosis. The
beads can be formulated to produce first or zero order release.
CEFORM-Registered Trademark-
CEFORM-Registered Trademark- is a microsphere technology used to
produce uniformly sized and shaped microspheres of a wide range of
pharmaceutical compounds. The microspheres are nearly perfectly spherical in
shape, typically have a diameter of 150 - 180 microns, and allow for high
drug content. CEFORM-Registered Trademark- microspheres are produced using a
continuous, single-step and solvent-free manufacturing process that can be
used to formulate drugs that are generally thermally unstable because of the
very brief application of heat and the wide range of temperatures which can
be used in the manufacturing process. Depending on the desired release
characteristics and
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oral dosage format, CEFORM-Registered Trademark- microspheres can be
formulated for controlled-release, enhanced absorption, and taste masking.
SHEARFORM-Registered Trademark-
Shearform-Registered Trademark- is used to produce matrices of
saccharides, polysaccharides, or other carrier materials that are
subsequently processed into amorphous fibers or flakes and recrystallized to
a predetermined level. This process is used to produce rapid dissolve
formulations, including Flash Dose-Registered Trademark-.
Shearform-Registered Trademark- can also be applied to food product
ingredients to provide enhanced flavoring.
OPERATIONS
RESEARCH AND DEVELOPMENT
Our staff of scientists has expertise in all aspects of the drug
development process, from pre-formulation studies and formulation development
to scale-up and manufacturing. We have successfully developed appropriate
delivery systems for pharmaceutical compounds exhibiting a wide range of
solubility and hydrophobicity characteristics.
Currently, our primary research and development (and administrative)
facilities are located in Mississauga, Ontario, Canada. Our recently acquired
Fuisz Technlogies Ltd. ("Fuisz") research and development facilities are
located in Chantilly, Virginia. We are in process of evaluating our business
planning with a view to integration of certain of these research and
development facilities.
MANUFACTURING AND FACILITIES
We currently operate two modern, fully-integrated pharmaceutical
manufacturing facilities located in Steinbach, Manitoba, Canada and Carolina,
Puerto Rico, respectively. Both facilities meet FDA-mandated good
manufacturing practices and are inspected on a regular basis by U.S.,
Canadian and other regulatory bodies and our own auditing team to ensure
compliance on an ongoing basis with such standards. Both manufacturing
facilities are currently producing Tiazac-Registered Trademark- for
distribution in the United States and Canada, and the Manitoba facility is
producing our generic version of Trental for distribution in the United
States. Our generic version of Cardizem CD is being produced in our Carolina,
Puerto Rico facility and encapsulated in Steinbach, Manitoba. In addition,
through the recent acquisition of Fuisz we acquired research and
manufacturing facilities in Chantilly, Virginia. The addition of the
Chantilly, Virginia facilities provides us with a base for increased U.S.
expansion opportunities.
We have also entered into an agreement for the acquisition of a
120,000 square foot manufacturing facility on 19 acres of land in Dorado,
Puerto Rico. We are scheduled to take final possession of the Dorado facility
in January 2001. We will have access to the Dorado facility during 2000 to
conduct some scale-up manufacturing activities and to begin the process of
transferring the manufacturing of some of our products currently manufactured
in our Manitoba facility to our Dorado facility.
Our 75,000 square foot plant in Steinbach, Manitoba was constructed
in 1994. Its manufacturing processes include (1) granulation and coating with
solvents, bead extrusion and spheronization; (2) fluid bed drying and
tableting; (3) high speed encapsulation with 100% quality control weight
checks and (4) high speed automatic packaging lines.
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The Carolina, Puerto Rico facilities total 34,000 square feet,
including 23,000 square feet of manufacturing capacity and 11,000 square feet
of additional leased warehouse space. This plant is specially constructed for
the high volume production of controlled-release beads.
CONTRACT RESEARCH DIVISION
Our CRD provides us and other pharmaceutical companies with a broad
range of clinical research services, including pharmacokinetic studies and
bioanalytical laboratory testing. The CRD can also provide support services
to its clients in the area of quality assurance.
Operating as an independent business unit with its own independent
internal ethics review board, the CRD is located in a 33,000 square foot
stand-alone facility owned by us and an 11,000 square foot facility leased by
us, in each case located in Toronto, Ontario. These facilities include a
fully equipped bioanalytical laboratory, a department of biopharmaceutics and
statistical analysis and a live-in 200-bed study clinic.
To date, the CRD has designed and conducted in excess of 1,700 Phase
I bioavailability, bioequivalence and drug interaction studies involving in
excess of 180 pharmaceutical products. Therapeutic areas in which studies
have been completed include cardiovascular, cardiopulmonary, bone and joint
disease, pain management, infectious diseases, central nervous system,
gastroenterology and endocrinology. In addition, the CRD is active and
experienced in the design and implementation of Phase III and Phase IV
clinical trials from protocol design and monitoring to completion of
statistical reports.
The CRD includes a full-service bioanalytical laboratory which
performs specialized bioanalytical and quality control testing and method
development as well as other laboratory services for major regional and
multinational pharmaceutical concerns. The laboratory is subject to full
compliance with applicable regulations and standards required by United
States, Canadian and certain other foreign regulatory bodies.
EMPLOYEES
As of February 29, 1999, we employed 703 employees (including 150 part-time
employees).
REGULATORY AFFAIRS AND QUALITY ASSURANCE
Our Corporate Regulatory Affairs Department performs a key role in
every aspect of the development and registration of each product and has
prepared product submissions for regulatory agencies in the United States,
Canada, the United Kingdom and the European Union. This department also
coordinates all data and document management, including amendments,
supplements and adverse events reporting. Our Quality Assurance Department
seeks to ensure that all stages of product development and production fully
comply with Good Clinical, Laboratory and Manufacturing Practices.
PATENTS AND PROPRIETARY RIGHTS
We have not routinely sought patents on our controlled-release
technology because (1) a significant number of our current products under
development are generic drugs and, when another company files an ANDA which
competes with any ANDA filed for one of our generic products, patent
protection would not afford benefits (which normally accrue to NDA holders)
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and (2) the filing of certain patents may provide potential competitors with
information relating to proprietary technology which may enable such
competitors to exploit information related to such technology which is not
within the confines of the protection of the patent. Historically, we have
relied on trade secrets, know-how and other proprietary information. While
certain of our licensors have sought patents on controlled-release technology
licensed to it, there can be no assurance that any patents will be issued or,
if issued, that the manufacture, use, sale, importation or offer for sale of
such patented matter will not infringe upon other patents or technology. Our
ability to compete effectively with other companies will depend, in part,
upon our ability to maintain the proprietary nature of our technology and to
avoid infringing patents of others. To protect our rights in these areas, we
require all licensors, licensees and significant employees to enter into
confidentiality agreements. There can be no assurance, however, that these
agreements will provide meaningful protection for our trade secrets, know-how
or other proprietary information in the event of any unauthorized use or
disclosure of such trade secrets, know-how or other proprietary information.
COMPETITION
The pharmaceutical industry is highly competitive and subject to
rapid and significant technological change. Our products face competition
from both conventional forms of drug delivery and controlled-release drug
delivery systems developed, or under development, by other pharmaceutical
concerns. Many of these competitors have greater financial resources and
marketing capabilities than we have. Our competitors in the United States and
abroad are numerous and include, among others, major pharmaceutical and
chemical companies, including, without limitation, some of the licensees (or
potential licensees) of our products, specialized contract research and
research and development firms, universities and other research institutions.
We believe that our controlled-release technology combined with our strategy
of funding and controlling all or most aspects of our controlled-release
pharmaceutical business will provide the cost savings, efficiencies in
product development and acceleration of regulatory filings necessary for it
to compete effectively with such firms and institutions. Our competitors,
however, may succeed in developing technologies and products that are as, or
more, clinically or cost-effective than any that are being developed or
licensed by us or that would render our technologies and products obsolete or
uncompetitive. In addition, certain of our competitors have greater
experience than us in clinical testing and human clinical trials of
pharmaceutical products and in obtaining FDA and other regulatory approvals.
REGULATION
The research and development, manufacture and marketing of
controlled-release pharmaceuticals are subject to regulation by U.S.,
Canadian and foreign governmental authorities and agencies. Such national
agencies and other federal, state, provincial and local entities regulate the
testing, manufacturing, safety and promotion of our products. The regulations
applicable to our products may change as the currently limited number of
approved controlled-release products increases and regulators acquire
additional experience in this area.
UNITED STATES REGULATION
NEW DRUG APPLICATION
We will be required by the FDA to comply with NDA procedures for our
branded products prior to commencement of marketing by us or our licensees.
New drug compounds and new formulations for existing drug compounds which
cannot be filed as ANDAs are subject to NDA procedures. These procedures
include (1) preclinical laboratory and animal toxicology tests;
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(2) scaling and testing of production batches; (3) submission of an
Investigational New Drug Application ("IND"), which must become effective
before human clinical trials commence; (4) adequate and well controlled human
clinical trials to establish the safety and efficacy of the drug for its
intended indication; (5) the submission of an NDA to the FDA; and (6) FDA
approval of an NDA prior to any commercial sale or shipment of the product,
including pre-approval and post-approval inspections of its manufacturing and
testing facilities. If all of this data in the product application is owned
by the applicant, the FDA will issue its approval without regard to patent
rights that might be infringed or exclusivity periods that would affect the
FDA's ability to grant an approval if the application relied upon data which
the applicant did not own. We intend to generate all data necessary to
support FDA approval of the applications we file.
Preclinical laboratory and animal toxicology tests must be performed
to assess the safety and potential efficacy of the product. The results of
these preclinical tests, together with information regarding the methods of
manufacture of the products and quality control testing, are then submitted
to the FDA as part of an IND requesting authorization to initiate human
clinical trials. Once the IND notice period has expired, clinical trials may
be initiated, unless a hold on clinical trials has been issued by the FDA.
Clinical trials involve the administration of a pharmaceutical
product to individuals under the supervision of qualified medical
investigators. Clinical studies are conducted in accordance with protocols
that detail the objectives of a study, the parameters to be used to monitor
safety and the efficacy criteria to be evaluated. Each protocol is submitted
to the FDA and to an Institutional Review Board prior to the commencement of
each clinical trial. Clinical studies are typically conducted in three
sequential phases, which may overlap. In Phase I, the initial introduction of
the product into human subjects, the compound is tested for safety, dosage,
tolerance, metabolic interaction, distribution, excretion and
pharmacodynamics. Phase II involves studies in a limited patient population
to (1) determine the efficacy of the product for specific targeted
indications; (2) determine optimal dosage and (3) identify possible adverse
effects and safety risks. In the event Phase II evaluations demonstrate that
a pharmaceutical product is effective and has an acceptable safety profile,
Phase III clinical trials are undertaken to further evaluate clinical
efficacy of the product and to further test its safety within an expanded
patient population at geographically dispersed clinical study sites. Periodic
reports on the clinical investigations are required. We or the FDA may
suspend clinical trials at any time if either party believes the clinical
subjects are being exposed to unacceptable health risks. The results of the
product development, analytical laboratory studies and clinical studies are
submitted to the FDA as part of an NDA for approval of the marketing and
commercialization of a pharmaceutical product.
The above-described NDA procedures are premised on the applicant
being the owner of, or having obtained a right of reference to, all of the
data required to prove safety and efficacy. These NDAs are governed by 21
U.S.C. Section 355(b)(1), also known as Section 505(b)(1) of the FDC Act.
ABBREVIATED NEW DRUG APPLICATION
In certain cases, where the objective is to develop a generic
version of an approved product already on the market in controlled-release
dosages, an ANDA may be filed in lieu of filing an NDA. Under the ANDA
procedure, the FDA waives the requirement to submit complete reports of
preclinical and clinical studies of safety and efficacy and instead requires
the submission of bioequivalency data, that is, demonstration that the
generic drug produces the same effect in the body as its brand-name
counterpart and has the same pharmacokinetic profile, or change in blood
concentration over time. The ANDA procedure would be available to us for a
generic version of a drug product approved by the FDA. In certain cases, an
ANDA applicant may submit a suitability petition to the FDA requesting
permission to submit an ANDA for a
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drug product that differs from a previously approved reference drug product
(the "Listed Drug") when the change is one authorized by statute. Permitted
variations from the Listed Drug include changes in: (1) route of
administration; (2) dosage form; (3) strength and (4) one of the active
ingredients of the Listed Drug when the Listed Drug is a combination product.
The FDA must approve the petition before the ANDA may be submitted. An
applicant is not permitted to petition for any other kinds of changes from
listed drugs. The information in a suitability petition must demonstrate that
the change from the Listed Drug requested for the proposed drug product may
be adequately evaluated for approval without data from investigations to show
the proposed drug product's safety or effectiveness. The advantages of an
ANDA over an NDA include reduced research and development costs associated
with bringing a product to market, and generally a shorter review and
approval time at the FDA.
PATENT CERTIFICATION AND EXCLUSIVITY ISSUES
ANDAs are required to include certifications with respect to any
patents which claim the Listed Drug or which claim a use for the Listed Drug
for which the applicant is seeking approval. If applicable patents are in
effect and this information has been submitted to the FDA, the FDA must delay
approval of the ANDA until the patents expire. If the applicant believes it
will not infringe the patents, it can make a patent certification to the
holder of patents on the drug for which a generic drug approval is being
sought, which may result in patent infringement litigation which could delay
the FDA approval of the ANDA for up to 30 months. If the drug product covered
by an ANDA were to be found by a court to infringe another company's patents,
approval of the ANDA could be delayed until the patents expire. Under the FDC
Act, the first filer of an ANDA with a "non-infringement" certification is
entitled to receive 180 days of market exclusivity. Subsequent filers of
generic products would be entitled to market their approved product six
months after the earlier of the first commercial marketing of the first
filer's generic product or a successful defense of a patent infringement suit.
Patent expiration refers to expiry of U.S. patents (inclusive of any
extensions) on drug compounds, formulations and uses. Patents outside the
United States may differ from those in the United States. Under U.S. law, the
expiration of a patent on a drug compound does not create a right to make,
use or sell that compound. There may be additional patents relating to a
person's proposed manufacture, use or sale of a product that could
potentially prohibit such person's proposed commercialization of a drug
compound.
The FDC Act contains non-patent market exclusivity provisions which
offer additional protection to pioneer drug products and are independent of
any patent coverage that might also apply. Exclusivity refers to the fact
that the effective date of approval of a potential competitor's ANDA to copy
the pioneer drug may be delayed or, in certain cases, an ANDA may not be
submitted until the exclusivity period expires. Five years of exclusivity are
granted to the first approval of a "new chemical entity." Three years of
exclusivity may apply to products which are not new chemical entities, but
for which new clinical investigations are essential to the approval. For
example, a new indication for use or a new dosage strength of a
previously-approved product may be entitled to exclusivity, but only with
respect to that indication or dosage strength. Exclusivity only offers
protection against a competitor entering the market via the ANDA route, and
does not operate against a competitor that generates all of its own data and
submits a full NDA under Section 505(b)(1) of the FDC Act.
If applicable regulatory criteria are not satisfied, the FDA may
deny approval of an NDA or an ANDA or may require additional testing. Product
approvals may be withdrawn if compliance with regulatory standards is not
maintained or if problems occur after the product reaches the market. The FDA
may require further testing and surveillance programs to monitor the
pharmaceutical product that has been commercialized. Noncompliance with
applicable
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requirements can result in additional penalties, including product seizures,
injunction actions and criminal prosecutions.
CANADIAN REGULATION
The requirements for selling pharmaceutical drugs in Canada are
substantially similar to those of the United States described above.
INVESTIGATIONAL NEW DRUG APPLICATION
Before conducting clinical trials of a new drug in Canada, we must
submit a pre-clinical submission to the TPP. This application includes
information about the methods of manufacture of the drug and controls, and
preclinical laboratory and animal toxicology tests on the safety and
potential efficacy of the drug. If, within 60 days of receiving the
application, the TPP does not notify us that our application is
unsatisfactory, we may proceed with clinical trials of the drug. The phases
of clinical trials are the same as those described above under "United States
Regulation-New Drug Application."
NEW DRUG SUBMISSION
Before selling a new drug in Canada, we must submit an NDS to the
TPP and receive a notice of compliance from the TPP to sell the drug. The NDS
includes information describing the new drug, including its proper name, the
proposed name under which the new drug will be sold, a quantitative list of
ingredients in the new drug, the methods of manufacturing, processing, and
packaging the new drug, the controls applicable to these operations, the
tests conducted to establish the safety of the new drug, the tests to be
applied to control the potency, purity, stability and safety of the new drug,
the results of clinical trials, the intended indications for which the new
drug may be prescribed and the effectiveness of the new drug when used as
intended. The TPP reviews the NDS. If the NDS meets the requirements of
Canada's Food and Drugs Act and Regulations, the TPP will issue a notice of
compliance ("NOC")for the new drug.
Where the TPP has already approved a drug for sale in
controlled-release dosages, we may seek approval from the TPP to sell an
equivalent generic drug. In certain cases, the TPP does not require the
manufacturer of a drug that is equivalent to a drug that has already been
approved for sale by the TPP to conduct preclinical tests and clinical
trials; instead, the manufacturer must satisfy the TPP that the drug is
bioequivalent to the drug that has already been approved.
The TPP may deny approval or may require additional testing of an
NDS if applicable regulatory criteria are not met. Product approvals may be
withdrawn if compliance with regulatory standards is not maintained or if
problems occur after the product reaches the market. Contravention of
Canada's Food and Drugs Act and Regulations can result in fines and other
sanctions, including product seizures and criminal prosecutions.
Proposals have recently been made that, if implemented, would
significantly change Canada's drug approval system. In general, the
recommendations emphasize the need for efficiency in Canadian drug review.
Proposals include establishment of a separate agency for drug regulation and
modeling the approval system on those found in European Union countries.
There is no assurance, however, that such changes will be implemented or, if
implemented, will expedite the approval of controlled-release products.
The Canadian government has regulations which can prohibit the
issuance of an NOC for a patented medicine to a generic competitor, provided
that the patentee or an exclusive licensee has filed a list of its Canadian
patents covering that medicine with the Minister of Health and
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Welfare. After submitting the list, the patentee or an exclusive licensee can
commence a proceeding to obtain an order of prohibition directed to the
Minister prohibiting him or her from issuing an NOC. The minister may be
prohibited from issuing an NOC permitting the importation or sale of a
patented medicine to a generic competitor until patents on the medicine
expire or the waiver of infringement and/or validity of the patent(s) in
question is resolved by litigation in the manner set out in such regulations.
There may be additional patents relating to a company's proposed manufacture,
use or sale of a product that could potentially prohibit such company's
proposed commercialization of a drug compound.
Certain provincial regulatory authorities in Canada have the ability
to determine whether the consumers of a drug sold within such province will
be reimbursed by a provincial government health plan for that drug by listing
drugs on formularies. The listing or non-listing of a drug on provincial
formularies may affect the prices of drugs sold within provinces and the
volume of drugs sold within provinces.
ADDITIONAL REGULATORY CONSIDERATIONS
Sales of our products by our licensees outside the United States and
Canada are subject to regulatory requirements governing the testing,
registration and marketing of pharmaceuticals, which vary widely from country
to country.
Our manufacturing facilities located at Steinbach, Manitoba and
Carolina, Puerto Rico operate according to FDA mandated Good Manufacturing
Practices. The manufacturing facilities are inspected on a regular basis by
the FDA, the TPP and other regulatory authorities. Our self-auditing team
seeks to ensure compliance on an ongoing basis with FDA mandated Good
Manufacturing Practices. From time to time, the FDA, the TPP or other
regulatory agencies may adopt regulations that may significantly affect the
manufacture and marketing of our products.
In addition to the regulatory approval process, pharmaceutical
companies are subject to regulations under provincial, state and federal law,
including requirements regarding occupational safety, laboratory practices,
environmental protection and hazardous substance control, and may be subject
to other present and future local, provincial, state, federal and foreign
regulations, including possible future regulations of the pharmaceutical
industry. We believe that we are in compliance in all material respects with
such regulations as are currently in effect.
ITEM 2. DESCRIPTION OF PROPERTIES
We own and lease space for manufacturing, warehousing, research,
development, sales, marketing, and administrative purposes. We own two
modern, fully-indegrated pharmaceutical manufacturing facilities: one in
Steinbach, Manitoba, Canada totaling 75,000 square feet and the second in
Carolina, Puerto Rico totaling 34,000 square feet. In addition, through the
recent acquisition of Fuisz, we acquired research and manufacturing
facilities in Chantilly, Virginia totaling approximately 24,000 square feet.
Our CRD is located in a 33,000 square foot owned facility and an 11,000
square foot leased facility, each of which is located in Toronto, Ontario,
Canada. Our corporate office, formulations development research and the
Canadian sales and marketing operation are located in a 35,000 square foot
leased facility in Mississauga, Ontario, Canada. We also lease 2,500 square
feet of office space in St. Michael, Barbados and 11,000 square feet of
warehouse space in Carolina, Puerto Rico. We have also agreed to acquire a
120,000 square foot manufacturing facility located on 19 acres of land in
Dorado, Puerto Rico. We are scheduled to take final possession of the Dorado
facility in January 2001. We will have access to the Dorado facility during
2000 to conduct some scale-up manufacturing activities and to begin the
process of transferring the manufacturing of some of our products currently
manufactured in our Manitoba facility.
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ITEM 3. LEGAL PROCEEDINGS
In March 1998, Biovail commenced an action in the district court of
New Jersey against Hoechst Aktiengesellschaft and related parties to recover
monetary damages and gain injunctive relief for what Biovail believes to be
violations of U.S. anti-trust law. In addition, Biovail's complaint alleges
that the various defendant parties engaged in breach of contract, deceptive
trade practices, restraint of trade, unfair competition and other violations
of the law. The action is proceeding to documentary and witness discovery.
Biovail anticipates a trial by early 2001.
From time to time, Biovail becomes involved in various legal
proceedings which it considers to be in the ordinary course of business. The
vast majority of these proceedings involve intellectual property issues that
often result in patent infringement suits brought by patent holders upon the
filing of ANDA applications. The timing of these actions is mandated by
statute and may result in a delay of FDA approval for such filed ANDAs until
the final resolution of such actions or the expiry of 30 months, whichever
occurs earlier.
In this regard, Biovail and its wholly owned subsidiary, Biovail
Laboratories, Inc. ("Biovail Laboratories"), have been sued in separate
lawsuits by Bayer AG and Bayer Corporation, as well as by Pfizer Inc.
("Pfizer"), upon the filing by Biovail Laboratories of separate ANDAs for
generic versions of Procardia XL and Adalat CC. These actions make the usual,
technical claims of infringement. Biovail is vigorously defending these suits
and is aggressively pursuing motions for summary judgment in due course.
Biovail has denied the allegations and has pleaded affirmative defenses that
the patents are invalid, have not been infringed and are unenforceable.
On April 23, 1998, Biovail filed a four-count complaint against
Bayer AG, Bayer Corporation and Pfizer seeking a declaratory judgment that
their patent is invalid, unenforceable, and not infringed by our filing of
the ANDAs. Biovail has also asserted that Bayer corporation and Pfizer have
violated anti-trust laws and have interfered with Biovail's prospective
economic advantage. Biovail's action has been stayed until the conclusion of
the patent infringement suits.
On August 25, 1998, Andrx Pharmaceutical, Inc. ("Andrx") submitted
to Biovail a Notice of Certification under the FDC Act certifying that the
ANDA filed by Andrx for a generic version of Tiazac-Registered Trademark- did
not infringe on Biovail's patent. In October 1998, Biovail commenced a patent
infringement suit against Andrx. A non-jury trial in this action was
completed in February 2000. On March 8, 2000, the district court ruled in
favor of Andrx stating that there was no infringement of Biovail's patent.
Biovail has appealed this ruling. Andrx' ANDA for its generic version of
Tiazac has not yet been tentatively approved by the FDA. Under current FDA
regulations, the FDA will not approve Andrx' ANDA for a period of 30 months
from the date Biovail first received the Notice of Patent Certification or
the date when Andrx successfully defends Biovail's appeal, whichever occurs
first.
In November 1999, Biovail acquired Fuisz Technologies Ltd. ("Fuisz").
Fuisz is now a wholly-owned subsidiary of Biovail and has been renamed
Biovail Technologies Ltd. ("Biovail Technologies").
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In February 2000 Biovail Technologies filed a complaint in Circuit
Court of Fairfax County, Va. against Richard C. Fuisz, former chairman of
Fuisz Technologies Ltd. and several other former Fuisz executives, directors,
and employees and related parties (the "Complaint"). The Complaint charges
breaches of fiduciary duties, breaches of contract, fraud, conversion,
business conspiracy and unjust enrichment arising out of a pattern of
misconduct in which the defendants pursued their personal advancement at the
expense of Fuisz. Biovail Technologies seeks $25 million in damages, treble
damages of $75 million, interest, punitive damages and attorneys fees.
Biovail believes that the allegations against the defendants are meritorious
and is in the process of vigorously litigating the suit.
In connection with the Fuisz acquisition Biovail entered into a
Consulting Agreement (the "Consulting Agreement") and an Option Agreement
(the "Option Agreement") (together, the "Agreements") with Richard Fuisz.
Pursuant to the Agreements Biovail acquired Richard Fuisz' shares in Fuisz
Technologies Ltd. In March 2000, Richard Fuisz commenced an action in the
district court of Delaware against Biovail (the "Delaware Action"). The
Delaware Action alleges that Biovail fraudulently induced the Agreements and
that Biovail is in breach of the Agreements. The Delaware Action seeks
rescission of the Agreements plus damages or, in the alternative, payment of
a sum of $8 million plus interest pursuant to the Consulting Agreement.
Though it is currently premature to predict the outcome of this action,
Biovail believes that the Delaware Action is without merit and intends to
vigorously defend the lawsuit.
While Biovail is not currently able to determine the potential
liability, if any, related to such matters, Biovail believes that none of the
matters, individually or in aggregate, will have a material adverse effect on
Biovail's financial position, results of operations or cash flows.
ITEM 4. CONTROL OF REGISTRANT
(a) As far as known to the Company, Biovail is not directly or indirectly
owned or controlled by another corporation(s) or by any foreign
government.
(b) Other than as provided below, we are not aware of any shareholders
owning more than 10% of our outstanding voting securities as of March 31,
2000.
<TABLE>
<CAPTION>
NAME OF BENEFICIAL OWNER COMMON SHARES OWNED PERCENT(1)
- ------------------------ ------------------- ----------
<S> <C> <C>
Eugene Melnyk(2) 12,654,326 19.6%
Officers and directors as a group (8 persons)(2) 13,196,440 20.4%
</TABLE>
(1) Does not include 5,223,400 common shares issuable upon exercise of stock
options outstanding under our stock option plan, 7,475,000 common shares
issuable upon exercise of outstanding warrants, 88,310 common shares to
be issued following the effectiveness of the registration statement with
respect to the Fuisz acquisition and 8,203 common shares issuable upon
conversion of the Fuisz Debentures.
(2) Mr. Melnyk also has options to purchase 2,490,000 common shares, of
which 1,530,000 have vested.
ITEM 5. NATURE OF TRADING MARKET
Our common shares are traded on the NYSE and on The Toronto Stock
Exchange ("TSE") under the symbol "BVF." The table below sets forth the high
and low sale prices for our common shares on the NYSE and the TSE during the
periods indicated. The reported last sale price of the common shares on March
31, 2000 on the NYSE was $44.31 and on the TSE was Cdn$63.00.
28
<PAGE>
<TABLE>
<CAPTION>
PRICE RANGE OF COMMON SHARES
---------------------------------------
NYSE TSE
--------------- ---------------------
HIGH LOW HIGH LOW
------ ------ --------- ---------
<S> <C> <C> <C> <C>
YEAR ENDED 1998:
1st Quarter $24.47 $16.75 Cdn$34.83 Cdn$23.88
2nd Quarter 23.45 15.00 33.50 22.38
3rd Quarter 17.38 12.13 26.50 18.48
4th Quarter 18.91 10.88 29.00 16.13
YEAR ENDED 1999:
1st Quarter $21.66 $17.28 Cdn$33.00 Cdn$25.53
2nd Quarter 25.56 16.19 37.25 23.93
3rd Quarter 29.50 23.91 44.25 34.85
4th Quarter 46.88 25.44 67.90 37.35
YEAR ENDING 2000:
1st Quarter $71.50 $38.50 Cdn$104.00 Cdn$55.00
</TABLE>
The following table indicates as of March 31, 2000, the approximate total
number of holders of record of Common Shares, the total number of Common
Shares outstanding, the number of holders of record of Common Shares with
United States addresses, the portion of the outstanding Common Shares held in
the United States, and the percentage of Common Shares held in the United
States:
<TABLE>
<CAPTION>
TOTAL NUMBER NUMBER OF PERCENTAGE OF
TOTAL NUMBER OF COMMON NUMBER OF COMMON SHARES COMMON SHARES
OF HOLDERS OF SHARES U.S. HOLDERS HELD BY U.S. HOLDERS HELD BY U.S. HOLDERS
RECORD (1) OUTSTANDING OF RECORD (2) OF RECORD OF RECORD
------------- ------------ ------------- -------------------- --------------------
<S> <C> <C> <C> <C>
586 64,642,575 198 54,536,351 84.36%
</TABLE>
(1) A substantial number of the Common Shares are held by depositories,
brokerage firms and financial institutions in "street name". Based upon the
number of annual reports and proxy statements requested by such nominees,
the Company estimates that the total number of beneficial holders of Common
Shares exceeds 4,000 holders.
(2) The computation of the number of Common Shares held in the United States is
based upon the number of holders of record with United States' addresses.
United States residents may beneficially own Common Shares owned of record
by non-United States residents.
DIVIDEND POLICY
The Company has not paid cash dividends on its Common Shares, and at
this time it intends to continue this policy for the foreseeable future in
order to retain earnings for the development and growth of the Company's
business. The Company's dividend policy will be reviewed periodically
29
<PAGE>
depending on the Company's financial position, capital requirements, general
business conditions and on other factors.
MARKET PRICE VOLATILITY OF COMMON SHARES
Market prices for the securities of pharmaceutical and biotechnology
companies, including Biovail, have historically been highly volatile, and the
market has from time to time experienced significant price and volume
fluctuations that are unrelated to the operating performance of particular
companies. Factors such as: fluctuations in the Company's operating results,
the aftermath of public announcements by the Company, concern as to safety of
drugs, and general market conditions, can have an adverse effect on the
market price of the Company's Common Shares.
ITEM 6. EXCHANGE CONTROLS AND OTHER LIMITATIONS AFFECTING SECURITY HOLDERS
There are currently no limitations imposed by Canadian federal or
provincial laws on the rights of non-resident or foreign owners of Canadian
securities to hold or vote the securities held. There are also no such
limitations imposed by the Company's articles and bylaws with respect to the
Common Shares of the Company.
INVESTMENT CANADA ACT
Under the Investment Canada Act, the acquisition of control of a
Canadian business by a "non-Canadian" is subject to review by the Investment
Review Division of Industry Canada ("Investment Canada"), a government
agency, and will not be allowed unless the investment is found likely to be
of "net benefit" to Canada. An acquisition of control will be reviewable by
Investment Canada if the value of the assets of the Canadian business for
which control is being acquired is (i) Cdn$5 million or more in the case of a
"direct" acquisition; (ii) Cdn$50 million or more in the case of an
"indirect" acquisition; or (iii) between Cdn$5 million or more but less than
$50 million where the Canadian assets acquired constitute more than 50% of
the value of all entities acquired, or if the acquisition is not effected
through the acquisition of control of a foreign corporation.
These thresholds have been increased for the purposes of acquisition
of control of a Canadian business by investors from members of the World
Trade Organization ("WTO"), including Americans, or WTO member-controlled
companies. A direct acquisition by a WTO investor is reviewable only if it
involves the direct acquisition of a Canadian business with assets of Cdn$192
million or more for the year 2000 (this figure is adjusted annually to
reflect inflation). Indirect acquisitions by WTO investors are not
reviewable, regardless of the size of the Canadian business acquired, unless
the Canadian assets acquired constitute more than 50% of the value of all
entities acquired, in which case the Cdn$192 million threshold applies.
These increased thresholds applicable to WTO investors do not apply
to the acquisition of control of a Canadian business that is engaged in
certain sensitive areas such as uranium production, financial services,
transportation or culture. In the case of the acquisition of control of a
cultural business, the Minister can elect to review the transaction even
where it does not exceed the lower asset threshold test above. Even if the
transaction is not reviewable, a non-Canadian must still give notice to
Investment Canada of the acquisition of control of a Canadian business within
30 days after its completion.
30
<PAGE>
COMPETITION ACT
Under the Competition Act (Canada) (the "Competition Act"), certain
transactions are subject to the pre-notification requirements of the Act
whereby notification of the transaction and specific information in
connection therewith must be provided to the Commissioner of Competition (the
"Commissioner"). A transaction may not be completed until the applicable
statutory waiting periods have expired, namely 14 days or 42 days for a
short-form or long-form filing, respectively. As well, where the parties
elect to file a short-form notification, the Commissioner may "bump" the
filing to a long-form, thereby restarting the clock once the parties submit
their filing.
A proposed transaction is subject to pre-notification only if the
parties to the transaction together with their affiliates have total assets
or total revenues from sales in, from or into Canada that exceed Cdn$400
million in aggregate value. Having met this first threshold, the parties must
then provide pre-notification if any one of the following additional
thresholds is met: 1) for an acquisition of assets in Canada where the
aggregate value of the assets or the gross revenues from sales in or from
Canada that are being acquired exceeds Cdn$35 million ("$35 million
threshold"); 2) in the case of an acquisition of shares of a company in
Canada, where as a result of the proposed acquisition, the person acquiring
the shares, together with its affiliates, would own more than 20% (or, if the
person making the acquisition already owns 20% or more of the voting shares
of the target, then 50%) of the voting shares of a corporation that are
publicly traded, or in the case of a company of which the shares are not
publicly traded, the threshold is 35% of the voting shares (and 50% if the
acquiror owns 35% or more of the voting shares of the subject company prior
to making the acquisition) and the $35 million threshold is exceeded; or 3)
in the case of a proposed amalgamation of two or more corporations where one
or more of the amalgamating corporations carries on an operating business
(either directly or indirectly) where the aggregate value of the assets in
Canada that would be owned by the continuing corporation resulting from the
amalgamation would exceed Cdn$70 million or the gross revenues from sales in
or from Canada generated from the assets of the amalgamated entity would
exceed Cdn$70 million.
Finally, all merger transactions, regardless of whether they are
subject to pre-merger notification, are subject to the substantive provisions
of the Competition Act namely, whether the proposed merger prevents or
lessens, or is likely to prevent or lessen, competition substantially in a
relevant market.
ITEM 7. TAXATION
CANADIAN FEDERAL INCOME TAXATION
The following discussion is a summary of the principal Canadian
federal income tax considerations generally applicable to purchasers of the
Company's Common Shares who, for purposes of the Income Tax Act (Canada) the
regulations thereunder, including proposed amendments thereto (the "Canadian
Act"), deal at arm's length with the Company, hold Common Shares as capital
property, are not resident in Canada at any time when holding Common Shares
and do not use or hold and are not deemed to use or hold Common Shares in or
in the course of carrying on business in Canada. This summary does not apply
to a holder of Common Shares that is an insurer that carries on an insurance
business in Canada and elsewhere.
GAINS ON DISPOSITION OF COMMON SHARES
Under the Canadian Act, a non-resident person who disposes or is
deemed to dispose of "taxable Canadian property" is subject to tax in Canada
on any gain from the disposition. The Common Shares will be taxable Canadian
property of a person if, at any time in the 60 month
31
<PAGE>
period immediately proceeding the disposition of Common Shares by that
person, that person or persons with whom that person does not deal at arm's
length, or that person together with such other persons owned (or had an
interest in or an option to acquire) 25% or more of the Common Shares or
Shares of any other class or series of stock of the Company. In some cases,
tax treaties entered into between Canada and other countries may provide an
exemption from such tax.
Under the provisions of the Canada - United States Income Tax
Convention, 1980, as amended, ("the Convention"), United States corporations
or individual residents of the United States ("U.S. Shareholders") that do
not, and are not deemed to, use or hold the Common Shares in or in the course
of carrying on a business in Canada ("Unconnected U.S. Shareholders")
generally will not be subject to Canadian federal income tax on any capital
gain realized upon the disposition of their Common Shares, provided that the
value of the Common Shares is not derived principally from real estate
situated in Canada, as determined at the time of the disposition. The Company
is of the view that the Common Shares currently do not derive their value
principally from such real estate.
However, under the Convention, even if the Common Shares do not
derive their value principally from Canadian real estate, Canada reserves the
right to tax a capital gain of a U.S. resident individual if the Common
Shares are taxable Canadian property and the individual was a resident of
Canada for 120 months during any period of 20 consecutive years preceding the
disposition and was a resident of Canada at any time during the 10 years
immediately preceding the disposition, if the Common Shares (or any shares
for which they were substituted in a non-recognition transaction) were owned
by the individual when he or she ceased to be a resident of Canada.
For United States federal income tax purposes, an Unconnected U.S.
Shareholder generally will recognize capital gain or loss on the disposition
of Common Shares in an amount equal to the difference between the amount
realized upon the disposition and the U.S. Shareholder's adjusted basis in
the Common Shares. Capital losses are deductible to the extent of capital
gains and, in the case of non-corporate U.S. Shareholders, may be used to
offset ordinary income.
TAXATION OF DIVIDENDS
Dividends paid to, and beneficially owned by, Unconnected U.S.
Shareholders owning less than 10% of the voting shares of the Company
generally are subject to Canadian withholding tax at the reduced rate of 15%
under the Convention. In the case of a dividend beneficially owned by a
corporate Unconnected U.S. Shareholder owning 10% or more of such shares, the
withholding tax rate generally is reduced to 5% under the Convention.
Unconnected U.S. Shareholders generally will treat the gross amount
of dividends paid by the Company, without reduction for Canadian withholding
taxes, as ordinary taxable income for United States federal income tax
purposes. In certain circumstances, however, Unconnected U.S. Shareholders
may be eligible to receive a foreign tax credit for such taxes and, in the
case of a corporate Unconnected U.S. Shareholder owning 10% or more of the
voting shares of the Company, for a portion of the Canadian taxes paid by the
Company itself. Dividends paid by the Company to United States corporations
will not, however, give rise to the dividends received deduction generally
allowed those corporations under United States federal income tax law.
The foregoing discussion of Canadian taxation and United States
taxation is of a general and summary nature only and is not intended to be,
nor should it be considered to be, legal or tax advice to any particular
shareholder. Accordingly, prospective investors should consult their own tax
advisors as to the tax consequences of receiving dividends from the Company
or disposing of their Common Shares.
32
<PAGE>
ITEM 8. SELECTED CONSOLIDATED FINANCIAL DATA
The following selected consolidated financial data of the Company is
qualified by reference to and should be read in conjunction with the
consolidated financial statements, related notes thereto, other financial
data, and "Management's Discussion and Analysis of Financial Condition and
Results of Operation" included elsewhere herein.
The consolidated operating data for the years ended December 31,
1997, 1998 and 1999, and the consolidated balance sheet data as at December
31, 1998 and 1999 are derived from and are qualified by reference to, the
audited consolidated financial statements included elsewhere in this
document. The consolidated operating data for the years ended December 31,
1995 and 1996 and the consolidated balance sheet data as December 31, 1995,
1996 and 1997 are derived from the audited consolidated financial statements
included as part of the Annual Report on Form 20-F for the prior three fiscal
years.
<TABLE>
<CAPTION>
1999 1998 1997 1996 1995
<S> <C> <C> <C> <C> <C>
CONSOLIDATED OPERATING DATA:
Revenue
Product Sales ........................ $ 99,526 $ 69,154 $50,333 $54,313 $ 7,915
Research and Development.............. 52,260 32,070 19,559 4,374 4,333
Royalty, Licensing and Other.......... 24,706 11,612 12,487 7,743 7,396
176,492 112,836 82,379 66,430 19,644
Expenses
Product Sales......................... 35,078 28,593 16,471 21,757 2,715
Research and Development.............. 33,130 17,490 14,386 10,901 7,194
Selling and Administrative............ 29,602 17,450 13,831 10,008 7,024
97,810 63,533 44,688 42,666 16,933
Operating Income......................... 78,682 49,303 37,691 23,764 2,711
Equity Loss.............................. (1,618) - - - -
Interest (Expense) Income, net........... (9,152) (1,702) (351) 392 (99)
Gain on Licensing Settlement............. - - - - 3,617
Gain on Disposal of Long-Term
Investments, net ...................... 1,948 - - - -
Income before Income Taxes and Goodwill
Amortization........................... 69,860 47,601 37,340 24,156 6,229
Provision for Income Taxes............... 4,215 2,024 1,941 714 201
Income before Goodwill Amortization...... 65,645 45,577 35,399 23,442 6,028
Goodwill Amortization.................... 3,165 158 158 158 158
Net Income............................... 62,480 45,419 35,241 23,284 5,870
Earnings Per Share (1)................... $ 1.22 $ 0.85 $ 0.69 $ 0.46 $ 0.12
BALANCE SHEET DATA:
Working Capital.......................... $266,068 $115,324 $47,663 $9,606 $ 696
Total Assets............................. 635,137 199,919 93,739 58,606 60,867
Long-Term Debt........................... 125,488 126,182 2,960 4,670 7,951
Shareholders' Equity..................... 435,294 51,191 75,458 36,943 14,592
STATISTICS AND RATIOS
Cash flow from operations per share...... $ 1.58 $ 1.00 $ 0.09 $(0.11) $ 0.63
Research and Development
spending as % of net revenues........ 18.8% 15.5% 17.5% 16.4% 36.6%
EBITDA................................... 85,987 54,102 40,690 25,573 3,791
</TABLE>
33
<PAGE>
<TABLE>
<S> <C> <C> <C> <C> <C>
EBITDA as % of net revenues.............. 48.7% 48.0% 49.4% 38.5% 19.3%
EBITDA as % return on Shareholders' equity 19.8% 105.7% 53.9% 69.2% 26.0%
EDITDA per share......................... $ 1.68 $ 1.02 $ 0.79 $ 0.50 $ 0.08
</TABLE>
Reconciliation of net income between generally accepted accounting principles
("GAAP") in Canada ("Cdn.") and the United States ("U.S.") (I)
<TABLE>
<CAPTION>
YEARS ENDED DECEMBER 31,
----------------------------------------------------------
1999 1998 1997 1996 1995
--------- -------- ------- ------- ------
<S> <C> <C> <C> <C> <C>
CONSOLIDATED INCOME (LOSS)
Net income under - Cdn. GAAP......................... $ 62,480 $45,419 $35,241 $23,284 $5,870
U.S. GAAP adjustments
Reversal (Write-off) of product
launch advertising costs......................... 426 (426) - - -
Collection of warrant subscription receivable...... (4,028) (1,179) (750) - -
Compensation cost of employee stock
Options (I)........................................ (7,641) (2,237) (1,669) (620) -
Acquired In-Process Research and development......... (136,215) - - - -
Acquired Product Right............................... (25,000) - - - -
Net income (loss) according to U.S. GAAP............. $(109,978) $41,577 $32,822 $22,664 $5,870
========= ======= ======= ======= ======
Earnings (loss) per share under U.S.GAAP
Basic........................................ $ (2.15) $ 0.78 $ 0.64 $ 0.45 $ 0.12
========= ======= ======= ======= ======
Weighted average number of common
shares outstanding under U.S. GAAP
Basic ....................................... 51,271 53,282 51,212 50,756 49,986
========= ======= ======= ======= ======
</TABLE>
Reconciliation of total assets between Cdn. GAAP and U.S. GAAP (I)
<TABLE>
<CAPTION>
YEARS ENDED DECEMBER 31,
-----------------------------------------------------------
1999 1998 1997 1996 1995
--------- -------- ------- ------- -------
<S> <C> <C> <C> <C> <C>
CONSOLIDATED TOTAL ASSETS
Total assets under Cdn. GAAP......................... $ 635,137 $199,919 $93,739 $58,606 $60,867
U.S. GAAP adjustments................................
Acquired in-process research and development....... (136,215) - - - -
Acquired product right............................. (25,000) - - - -
Adjustment to value of goodwill.................... (6,743) - - - -
Write-off of product launch advertising costs...... - (426) - - -
Unrealized holding losses on long-term investments. - (877) - - -
--------- -------- ------- ------- -------
Total assets under U.S. GAAP......................... $ 467,179 $198,616 $93,739 $58,606 $60,867
========= ======== ======= ======= =======
</TABLE>
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<PAGE>
The components of shareholders' equity under U.S. GAAP (I) are as follows:
<TABLE>
<CAPTION>
1999 1998
--------- --------
<S> <C> <C>
Share capital.......................... $ 373,962 $ 23,954
Warrants............................... 8,244 8,244
Warrant subscription receivable........ (2,287) (6,315)
Retained earnings...................... (113,843) 26,111
Accumulated other comprehensive loss... 1,260 (2,106)
--------- --------
$ 267,336 $ 49,888
========= ========
</TABLE>
(I) should be read in conjunction with the consolidated financial statements
and notes thereto, in particular note entitled "United States Generally
Accepted Accounting Principles."
ITEM 9 MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW OF 1999
GENERAL
During fiscal 1999, we experienced significant revenue and earnings
growth, while expanding our operations and enhancing our product development
pipeline. We successfully completed a number of corporate initiatives,
including: the acquisition of Fuisz; product licensing agreements with Mylan,
Elan and Spectral Diagnostics Inc. ("Spectral"); the acquisition of the
rights to Procardia XL from Intelligent Polymers; FDA approval for our
generic versions of Cardizem CD and Adalat CC; the launch of a generic
version of Verelan and the completion of a common share offering for gross
proceeds of $259 million.
FUISZ ACQUISITION
On November 12, 1999, we acquired Fuisz in order to enhance our drug
delivery and pharmaceutical business. Fuisz was a drug delivery company
focused on the enhanced delivery of drugs utilizing its patented technology
in the areas of controlled-release, rapid dissolve, enhanced absorption and
taste masking.
The total consideration paid for Fuisz, including costs of
acquisition, consisted of $75.6 million in cash, 1,544,155 of our common
shares with a fair value of $96.0 million and the assumption of approximately
$86.1 million of debt. We have recognized in our consolidated financial
statements our 49% equity interest in the results of Fuisz for the period
from September 4, 1999, the date we acquired significant influence, to
November 12, 1999, the date we acquired control of Fuisz. The assets,
liabilities, revenues and expenses of Fuisz have been included in our
consolidated financial statements since November 12, 1999.
The acquisition of Fuisz gave rise to a charge of $137.5 million,
relating to the acquisition of in-process research and development pursuant
to Statement of Financial Accounting Standard ("SFAS") No. 2. See Note 3 of
our consolidated financial statements for
35
<PAGE>
additional information relating to the Fuisz acquisition and Note 23(a) for
the relevant accounting treatment under Canadian and U.S. GAAP.
On October 22, 1999, Fuisz agreed to sell all of the issued shares
of three of its wholly-owned European subsidiaries for proceeds of $28.7
million and the assignment of the rights, privileges and advantages of the
CEBUTID trademark for proceeds of $10.3 million. No gain or loss was
recognized by us on these transactions as these subsidiaries were included in
the purchase price allocation at their fair value on September 4, 1999 when
we acquired our 49% interest in Fuisz.
We determined, as part of our evaluation of the purchase, that
certain operations of Fuisz were not strategic to our business plans and
accordingly should be sold. Effective January 4, 2000, we entered into an
agreement to sell all of the issued share capital of Clonmel Healthcare
Limited ("Clonmel"), a pharmaceutical and antibiotic manufacturer and
distributor located in Ireland, for proceeds of $20 million. No gain or loss
was recognized by us on this transaction, as this subsidiary was included at
fair value in the purchase price allocation at November 12, 1999.
We are continuing to complete a number of initiatives to reorganize
and integrate Fuisz into our operations. We recently completed the purchase
of $74.5 million of 7% convertible subordinated debentures (the "Fuisz
Debentures") assumed in connection with the Fuisz acquistion. We anticipate
that the operations of Fuisz will be fully integrated into our operations in
2000.
PRODUCT ACQUISITIONS
In March 1999, we entered into an arrangement with Mylan for the
marketing of all dosage strengths of a generic version of Verelan to take
advantage of our first ANDA filer status and Mylan's product approval. As a
result of this agreement, our marketing partner Teva entered the market
simultaneously with Mylan at an earlier date than would otherwise have been
achieved.
In July 1999, we acquired from Spectral the exclusive rights to
market Cardiac STATus in Canada. Cardiac STATus, a rapid point of care
diagnostic test, assists in the early identification of patients with heart
attacks or other acute coronary syndromes.
In October 1999, we acquired the exclusive marketing rights to
Elan's 30 mg generic version of Adalat CC in the United States in return for
future royalties. As a result of this acquisition, we will enter the market
earlier than would otherwise have been the case and will benefit from the 180
days of marketing exclusivity for this dosage strength previously held by
Elan.
In December 1999, we exercised our option to purchase the exclusive
product rights from Intelligent Polymers for its generic version of Procardia
XL for $25 million. Intelligent Polymers had filed an ANDA with the FDA
covering multiple dosage strengths for this product.
PRODUCT APPROVALS
In June 1999, we received tentative approval for our 30 mg and 60 mg
generic versions of Adalat CC from the FDA. In December 1999, we received
approval for our generic version of Cardizem CD from the FDA. Cardizem CD was
immediately launched by Teva in the United States.
36
<PAGE>
CORPORATE FINANCING INITIATIVES
In October 1999, we completed an equity offering for gross proceeds
of $259 million. These proceeds replenished cash used for the initial
purchase of 49% of Fuisz and funded the purchase of the Fuisz Debentures.
On March 22, 2000, we completed a financing comprising a concurrent offering
of U.S.$300,000,000 6.75% Convertible Subordinated Preferred Equivalent
Debentures, due March 31, 2025, and 2 million common shares, for gross
proceeds of U.S.$401 million. Approximately U.S.$141 million of the proceeds
have been used in the repurchase of our outstanding U.S.$125 million 10 7/8%
Senior Notes, due November 15, 2005 (the "Senior Notes"), and the balance
will be used for working capital and general corporate purposes.
RESULTS OF OPERATIONS
We derive our revenues from: (i) developing and licensing oral
controlled-release pharmaceutical products utilizing our proprietary drug
delivery technologies; (ii) manufacturing such products for sale to licensees
and wholesalers and from direct marketing of proprietary and in-licensed
products in Canada; and (iii) providing pharmaceutical contract research
services to third parties. Product sales arise from products developed and
manufactured on behalf of our clients or from products licensed from third
parties and sold by us. Royalties generally arise on sales of drug products
developed by us. License fees include fees relating to the license to third
parties of our technologies or product rights. Research and development fees
relate to product development activity and pharmaceutical contract research
services for third parties.
Revenues for 1999 were $176.5 million, a 56% increase over the
revenues of $112.8 million recorded in 1998. Revenues for 1998 were 37%
higher than the $82.4 million recorded in 1997. Income before goodwill
amortization in 1999 increased by 44% to $65.6 million, or $1.28 per share,
compared to $45.6 million, or $0.86 per share, in 1998 and $35.4 million, or
$0.69 per share, in 1997. Net income in 1999 increased by 38% to $62.5
million, or $1.22 per share, compared to $45.4 million, or $0.85 per share,
in 1998 and $35.2 million, or $0.69 per share, in 1997.
Our continued growth was due primarily to the strong performance of
Tiazac-Registered Trademark- in both the United States and Canada as well as
the launch of Verelan in the second quarter and Cardizem CD in December.
Crystaal launched four products in 1999, including Brexidol, Retavase, Celexa
and Cardiac STATus. Research and development revenues increased
significantly, reflecting the continuing development of branded products on
behalf of Intelligent Polymers and a record level of development activity at
CRD for third-party clients.
For the year ended December 31, 1999, sales of our principal
product, Tiazac-Registered Trademark-, accounted for 44% of our total
revenues. Sales of Tiazac-Registered Trademark- pursuant to agreements with
Forest accounted for approximately 42% of our total revenues. Research and
development services rendered to Intelligent Polymers accounted for 19%, 9%
and 12% of revenue for 1999, 1998 and 1997, respectively.
REVENUE
Product sales in 1999 were $99.5 million compared with $69.2 million
and $50.3 million in 1998 and 1997, respectively. The 44% growth in 1999 is
attributable to increased sales of Tiazac-Registered Trademark- to Forest for
distribution in the United States, the launch of Verelan in the second
quarter and Cardizem CD in December and the launch of four products in Canada
(Retavase,
37
<PAGE>
Brexidol, Celexa and Cardiac STATus). The increase in product sales in 1998
was due to increased sales of Tiazac-Registered Trademark- in Europe, to
Forest for distribution in the United States and sales of other products to
Teva.
Research and development revenues from third-party customers in 1999
were $52.3 million, compared to $32.1 million and $19.6 million in 1998 and
1997, respectively. The increase in 1999 relates to higher third-party
revenues and increased product development activities undertaken for
Intelligent Polymers, Lundbeck and Forest. Growth in these revenues in 1998
related to activities undertaken for Intelligent Polymers, Teva and Lundbeck.
Royalty and licensing revenue was $24.7 million in 1999, compared to
$11.6 million and $12.5 million in 1998 and 1997, respectively. The growth in
1999 was primarily attributable to a payment from Mylan in return for giving
up our exclusivity rights for a generic version of Verelan, a licensing fee
from Stada in return for exclusive marketing rights to Viazem in certain
European countries and certain other product licensing agreements. Royalty
and licensing revenues for 1998 reflected increased royalties on the sale of
Tiazac-Registered Trademark- to Forest, but declined due to the amortization
expense on the elimination of this royalty obligation and reduced royalty
revenues on Oruvail sales in the United States, where a competing generic
product was introduced.
COST OF GOODS SOLD AND GROSS MARGINS
The cost of goods sold as a percentage of product sales was 35% in 1999,
compared to 41% in 1998 and 33% in 1997. The Company's gross margins are
impacted by product sales, price, product mix and manufacturing volumes.
The improvement in 1999 margins over 1998 is due in part to higher
trade sales of Tiazac-Registered Trademark- to Forest. Since trade supplies
are sold at a higher price than samples and also have a lower cost due to
lower packaging and labor costs, 1999 margins were favorably impacted. The
launch of Cardizem CD and Verelan, which generate higher margins than
Tiazac-Registered Trademark-, had a positive impact on overall margins.
Margins in 1998 were lower than those in 1997 due to the declining
proportionate sale of Tiazac-Registered Trademark- in our overall product mix
as well as a one-time contractual price reduction to Forest of approximately
25%.
RESEARCH AND DEVELOPMENT
Research and development expenses for 1999 were $33.1 million (19%
of total revenues), compared to $17.5 million (16% of total revenues) and
$14.4 million (17% of total revenues) in 1998 and 1997, respectively. The
increase over 1998 related to increased work with respect to branded generic
products being developed on behalf of Intelligent Polymers, generic products
under development, increased third-party activities at CRD and research and
development expenses since November 12, 1999 resulting from the Fuisz
acquisition. Increased spending in 1998 related to the increased level of
activity for Intelligent Polymers, development of generic products under
agreement with Teva, and other activities for third party customers.
SELLING, GENERAL AND ADMINISTRATIVE
Selling, general and administrative expenses increased to $29.6
million (17% of total revenues) in 1999, compared to $17.5 million (15% of
total revenues) and $13.8 million (17% of total revenues) in 1998 and 1997,
respectively. The increase in 1999 was due to the expansion of the sales
force at Crystaal, higher advertising and promotion expenditures associated
with the
38
<PAGE>
launch of Retavase, Brexidol, Celexa and Cardiac STATus and increased legal
costs and the hiring of key management personnel. This 1998 increase was a
result of the full year's impact of increased sales and marketing costs
related to sale of Tiazac-Registered Trademark- in Canada and registration
costs associated with the introduction of Tiazac-Registered Trademark- in
European markets.
OPERATING INCOME
Segment operating income, as described in Note 22 to the financial
statements, before unallocated selling, general and administrative expenses,
was $87.5 million in 1999, compared to $55.1 million and $40.4 million in
1998 and 1997, respectively. Of this total, product sales accounted for $46.3
million, compared to $30.8 million and $24.9 million in 1998 and 1997,
respectively. The increase in 1999 product sales related to increased sales
of Tiazac-Registered Trademark- in the United States and the launch of
Verelan and Cardizem CD during the year. The 1998 increase resulted from
increased sales of Tiazac-Registered Trademark- in the United States and
Europe and shipments to Teva. Research and development accounted for $16.9
million in 1999, compared to $13.0 million and $3.6 million in 1998 and 1997,
respectively. The increase in 1999 reflects a higher proportion of research
and development operating income being earned from Intelligent Polymers and
third-party development activities. Increases in 1998 also resulted from
these activities, together with improved margins from CRD. Royalty and
licensing activities generated operating income of $24.3 million, compared to
$11.3 million and $12.0 million in 1998 and 1997, respectively. Growth in
1999 was due to the previously mentioned licensing fees received for various
product and geographic opportunities while the decline in 1998 was largely
due to amortization and reduced royalties from Oruvail sales in the United
States. Operating income after allocation of selling, general and
administrative expenses for 1999 was $78.7 million, compared to $49.3 million
and $37.7 million in 1998 and 1997, respectively.
NON-OPERATING EXPENSES
Non-operating expenses include the equity loss in Fuisz of $1.6 million
for the period September 4, 1999 to November 12, 1999. Fuisz has been
consolidated with our results from November 12, 1999. Net interest expense in
1999 was $9.2 million compared with $1.7 million and $0.4 million in 1998 and
1997, respectively. Net interest expense in 1999 included interest on the $125
million aggregate principal amount of Senior Notes which were offered in
November 1998, less interest earned on the proceeds invested from the 1999
equity offering and the sale of the European subsidiaries acquired through the
acquisition of Fuisz. Net interest expense in 1998 was largely interest expense
on our operating line of credit, which was used prior to the offering of the
Senior Notes.
INCOME TAXES
Income taxes in 1999, 1998 and 1997 of $4.2 million, $2.0 million and
$1.9 million, respectively, related to our foreign subsidiaries, in respect of
which lower statutory tax rates apply than those in Canada. The benefit of tax
losses historically incurred by the Canadian operations has not been recognized
for accounting purposes to date.
INCOME BEFORE GOODWILL AMORTIZATION
Income before goodwill amortization in 1999 was $65.6 million, $45.6
million and $35.4 million, or $1.28, $0.86 and $0.69 per share, for 1999, 1998
and 1997, respectively.
39
<PAGE>
NET INCOME
Income in 1999, excluding a net gain on the disposal of long-term
investments was $60.5 million or $1.18 per share.
Net income including the investment gain was $62.5 million, or $1.22
per share, in 1999, compared with $45.4 million, or $0.85 per share, in 1998 and
$35.2 million, or $0.69 per share, in 1997. Earnings per share have been
calculated using the weighted average number of common shares outstanding during
the year after giving effect to the 2 for 1 share split in December 1999.
NET INCOME (LOSS) ACCORDING TO U.S. GAAP
The net loss according to U.S. GAAP for 1999 was $110.0 million,
compared with net income of $41.6 million and $32.8 million in 1998 and 1997,
respectively. The loss in 1999 is due primarily to the write off of $136.2
million of in-process research and development under U.S. GAAP related to the
Fuisz acquisition, which is capitalized and amortized over its useful life of
fifteen years under Canadian GAAP. Additionally, $25 million of acquired product
rights is being written off in 1999. For the purpose of reporting under U.S.
GAAP, companies are required to write off the cost of intangibles that are
purchased from others for research and development projects that have no
alternative future use at the time of acquisition. Under Canadian GAAP, these
costs have been capitalized. The loss per share in 1999 according to U.S. GAAP
is $2.15, compared with earnings per share of $0.78 and $0.64 for 1998 and 1997,
respectively.
EBITDA
EBITDA, defined as earnings before interest, taxes, depreciation and
amortization, was $86.0 million in 1999 compared with $54.1 million in 1998 and
$40.7 million in 1997. The ratio of total debt to EBITDA for 1999 was 1.6:1
compared to 2.3:1 in 1998 and 0.1:1 in 1997.
LIQUIDITY AND CAPITAL RESOURCES
At December 31, 1999, our cash position was $178.1 million, our cash
plus short-term investments was $244.0 million and our working capital was
$266.1 million, representing a working capital ratio of 4.6:1. During 1999 we
increased the amount of our cash through cash flow from operations ($81.0
million), the sale of common shares ($253.7 million) and the cash acquired in
the Fuisz acquisition ($38.2 million). Uses of cash included the acquisition of
shares of Fuisz common stock ($75.6 million), the purchase of outstanding Fuisz
Debentures ($74.5 million), the repurchase of our common shares in the open
market ($30.6 million) and the acquisition of product rights ($38.3 million).
On March 22, 2000, we completed a financing comprising a concurrent
offering of U.S.$300,000,000 6.75% Convertible Subordinated Preferred Equivalent
Debentures, due March 31, 2025 (the "Convertible Preferred Securities"), and 2
million common shares. The Convertible Preferred Securities were priced at 100%
of the principal amount and the common shares were priced at U.S.$50 9/16 per
share. On the same date, we used approximately U.S.$141 million of the proceeds
to repurchase the $125 million principal of our outstanding Senior Notes and pay
related expenses of approximately $16 million.
After consummation of the above financing and after payment of issue
expenses and purchase of all of our Senior Notes, on a pro forma basis we will
have total long-term indebtedness, including the Convertible Preferred
Securities (which are included as debt under U.S. GAAP), of $301.7 million and
total cash plus short-term investments of approximately $495.5 million.
40
<PAGE>
We believe that we have adequate capital resources and sources of
financing to support our ongoing operational and interest requirements and
investment objectives. We believe that we would be able to raise additional
capital, if necessary, to support our objectives.
We intend to publicly report our financial results for all periods
beginning on or after January 1, 2000 in accordance with U.S. GAAP. Pursuant to
U.S. GAAP, the Convertible Preferred Securities will be classified as long-term
debt and not as part of shareholders' equity. In addition, it is possible that
our financial statements for the three months ended March 31, 2000 will be
impacted by potential costs relating to the integration of certain of our
research and development facilities with those of Fuisz. We are currently
evaluating our business plans in this regard and, accordingly, we are not able
to determine the costs of this integration process.
RECENT ACCOUNTING DEVELOPMENTS
i) The Financial Accounting Standards Board has issued Statement No. 133
"Accounting for Derivative Instruments and Hedging Activities", as
amended by Statement No. 137 which is required to be adopted in years
beginning after June 15, 2000. We are determining the impact of the
adoption of the new statement.
ii) The SEC issued Staff Accounting Bulletin No. 101 "Revenue Recognition
in Financial Statements" in December 1999, which summarizes certain
views in applying generally accepted accounting principles to revenue
recognition in financial statements. The statements in the staff
accounting bulletins represent interpretations and practices followed
by the Divisions of Corporate Finance and the Office of the Chief
Accountant in administering the disclosure requirements of the U.S.
federal securities laws. The impact of the application of this Staff
Accounting Bulletin is currently being reviewed by us.
FORWARD-LOOKING STATEMENTS
To the extent any statements made in this document contain information
that is not historical, these statements are essentially forward-looking. As
such, they are subject to risks and uncertainties, including the difficulty of
predicting FDA and TPP approvals, acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing, new product
development and launch, reliance on key strategic alliances, availability of raw
materials, the regulatory environment, fluctuations on operating results and
other risks detailed from time to time in our filings with the SEC and Canadian
securities authorities.
ITEM 9A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
The Company does not believe that it has material exposure to financial
market risks, including changes in foreign currency exchange rates and interest
rates on debt instruments and short-term investments.
The Company and its subsidiaries generate revenue and incur expenses
primarily in U.S. dollars. In 1999, revenue was generated in the following
proportions: 71% in U.S. dollars and 29% in Canadian dollars. Expenses were
incurred in the following proportions: 47% in U.S. dollars and 53% in Canadian
dollars. The Company does not believe that it has significant exposure to
exchange risk because of the relative stability of the Canadian dollar in
relation to the U.S. dollar.
In March, 2000 the Company issued U.S.$300 million 6 3/4% Convertible
Subordinated Preferred Equivalent Debentures due March 31, 2025. The interest
rate on these securities is fixed and therefore is not subject to interest rate
risk. The proceeds were used, in part, to repurchase the Company's U.S.$125
million 10 7/8% Senior Notes, due November 15, 2005 for consideration of
41
<PAGE>
approximately U.S.$141 million. Such consideration included a consent payment of
U.S.$2.5 million and a premium of approximately U.S.$13.5 million calculated by
reference to the bid price and yield on March 6, 2000 for the 5 3/4% U.S.
Treasury Note due November 20, 2002.
From time to time the Company has surplus funds available for
investment. The Company's policy is to invest such funds in high grade
commercial paper and U.S. government treasury bills with varying maturities,
typically of less than 90 days. In light of the high quality and short-term
duration of these investments, the Company believes that there is no significant
risk to the principal value of these investments.
ITEM 10. DIRECTORS AND OFFICERS OF THE COMPANY
The name, municipality of residence, their ages as of March 31, 2000 and
position with the Company of each of the directors and executive officers are
set forth below:
<TABLE>
<CAPTION>
NAME (1) AGE POSITION
<S> <C> <C>
Eugene N. Melnyk (2).................... 40 Chairman of the Board and Director
St. Philip, Barbados
Bruce D. Brydon......................... 52 Chief Executive Officer and Director
Milton, Ontario, Canada
Robert A. Podruzny...................... 52 President, Chief Operating Officer and Director
Markham, Ontario, Canada
Kenneth C. Cancellara, Q.C.............. 53 Senior Vice President, General Counsel,
Toronto, Ontario, Canada Secretary and Director
Rolf K. Reininghaus..................... 54 Senior Vice President and Director
Mississauga, Ontario, Canada
Kenneth G. Howling...................... 42 Vice President, Chief Financial Officer
Toronto, Ontario, Canada
David Tierney, Ph.D., M.D. 36 President, Biovail Technologies Limited
Strewsbury, New Jersey, USA.............
Kenneth S. Albert, PhD.................. 57 Vice President, Chief Scientific Officer
Mount Kisco, New York, USA
Wilfred G. Bristow (2).................. 67 Director
Campbellville, Ontario, Canada
Roger Rowan (2)......................... 46 Director
Toronto, Ontario Canada
Robert Vujea............................ 74 Director
Grand Rapids, Michigan, USA
</TABLE>
- ------------------------
(1) Directors serve one year terms.
(2) Member of the Audit Committee.
MR. MELNYK has been the Chairman of the Board and a Director since
March 29, 1994, the effective date of the amalgamation (the "Amalgamation") of
the Company's predecessor entities, Biovail Corporation International ("BCI")
and Trimel Corporation ("Trimel"). Prior to that time, he had been the Chairman
of the Board of BCI since October 1991 and was instrumental in acquiring,
financing and organizing the companies or businesses that comprised BCI. Mr.
Melnyk
42
<PAGE>
also founded Trimel and served as its President and Chief Executive
Officer from 1983 through July 1991.
MR. BRYDON has been the Chief Executive Officer since November 1997. He
joined Biovail as the Chief Executive Officer and President in January 1995 and
has been a Director since May 1995. Prior to that time and since 1990 he had
been President, Managing Director and Chairman of the Board of the Canadian
Operations of Boehringer Mannheim. In the late 1980s, Mr. Brydon served as
President and CEO of Beiersdorf Canada.
MR. PODRUZNY has been the President and Chief Operating Officer since
November 1997. He joined Biovail as Vice President, Finance and Chief Financial
Officer in January 1996. Mr. Podruzny came to Biovail from Browning-Ferris
Industries Ltd. where he served as the Chief Financial Officer and as a Director
of the Canadian operation from 1993 to 1995. From 1987 to 1992, Mr. Podruzny
served as General Manager of the U.S. Health Promotion Division of MDS Health
Group, a Toronto-based medical services company.
MR. CANCELLARA joined Biovail as Senior Vice President and General
Counsel in March 1996, was appointed Secretary in April 1996, and has been a
Director since May 1995. Prior to that time, Mr. Cancellara was a partner with
the law firm of Cassels, Brock and Blackwell since 1980 where he held many
positions including Chairman of the Executive Committee and managing partner.
MR. REININGHAUS has been a Senior Vice President and a Director since
the Amalgamation and has been President of Crystaal since November 1997. Prior
to that time, he had been the President, Chief Operating Officer and a Director
of BCI since October 1991 and Executive Vice President and a Director of Trimel
Corp. or its affiliates since November 1987. Prior to his employment by Trimel,
Mr. Reininghaus was the Marketing Manager of the Canadian operations of Miles
Pharmaceuticals, a division of Bayer AG.
MR. HOWLING joined Biovail as Vice President, Finance and Chief Financial
Officer in November 1997. Mr. Howling came to Biovail from Pharma Patch Plc, a
small bio-technology company involved in transdermal drug delivery, where he
served as Vice President, Finance and Chief Financial Officer from November 1993
to November 1997. Mr. Howling served as General Manager and Corporate Secretary
from June 1991 to November 1993 and as Controller and Corporate Secretary from
June 1988 to June 1991 for Roberts Company Canada Limited. Prior to that time,
he spent 10 years in financial and general management positions including
positions with SmithKline Beecham, Bencard Allergy Laboratories, McGraw Edison
and Price Waterhouse. Mr. Howling is a Certified Public Accountant.
DR. TIERNEY joined us as President of Biovail Technologies Ltd. on January
31, 2000. Dr. Tierney has operational responsibility for all of Biovail's
research and development, regulatory and clinical activities and is based in
Chantilly, Virginia. Dr. Tierney was previously Senior Vice President, Drug
Development for Roberts Pharmaceutical Corporation with overall responsibility
for drug development, medical affairs, worldwide regulatory affairs and chemical
process development. Prior to joining Roberts in 1997, Dr. Tierney held senior
positions with Elan.
DR. ALBERT joined Biovail as Vice President, Chief Scientific Officer
in January, 1999. Dr. Albert came to Biovail from Schien Pharmaceutical Inc.,
where he had been the Vice President, Research and Development from 1995 to
1998. Prior to his tenure at Schein, Dr. Albert was Corporate Director, Research
and Development at Forest from 1988 to 1995 and prior to that time he spent 14
years in senior Research and Development positions at the Upjohn Company and
Merck Sharp and Dohme.
43
<PAGE>
MR. BRISTOW has been a Director since the Amalgamation. Prior to that
time, he had been a Director of BCI since January 1993. Mr. Bristow had been a
senior investment advisor at Nesbitt Thomson Inc., a Canadian investment banking
firm, since December 1991. From September 1975 to December 1991, he served as
vice president and director of Richardson Greenshields of Canada, an investment
banking firm.
MR. ROWAN was elected to the Board of Directors in June 1997. Mr. Rowan has
been President and Chief Operating Officer of Watt Carmichael Inc., a private
investment firm, since May 1994. Prior thereto, Mr. Rowan was the Executive Vice
President and Chief Operating Officer of Watt Carmichael Inc. since 1991.
MR. VUJEA was elected to the Board of Directors in June 1997. Mr. Vujea has
been President of R & D Chemical Corporation, a chemical manufacturer and
distributor, since 1974. Prior thereto, Mr. Vujea held senior management
positions within a number of companies including American Greeting Card
Corporation, Cole National Corporation and Diverco Incorporated.
ITEM 11. COMPENSATION OF DIRECTORS AND OFFICERS
The following table sets forth the compensation information for each of
the last three fiscal years for the Chief Executive Officer and the four other
most highly compensated executive officers of the Company who served as
executive officers at the end of 1999 ("Named Executive Officers"). This
information includes the dollar value of base salaries, performance bonus
awards, long-term incentive compensation payments, and certain other
compensation.
<TABLE>
<CAPTION>
SUMMARY COMPENSATION TABLE
----------------------------------------------------------------------------------------
ANNUAL COMPENSATION LONG TERM COMPENSATION
----------------------------------------------------------------------------------------
Awards Payments
----------------------------------------------------------------------------------------
Other Securities Restricted
Annual Under Shares or All Other
Compen- Options Restricted LTIP Payouts Compen-
Name and Principal Salary Bonus sation (2) Granted ShareUnits (U.S.$) sation (2)
Position Year (U.S.$) (U.S.$) (U.S.$) (3) (#) (U.S.$) (U.S.$)
- -----------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Eugene N. Melnyk 1999 456,731 - - 60,000 - - -
Chairman of the Board 1998 415,210 - - - - -
1997 377,463 - - 810,000 - 23,488,158 -
- -----------------------------------------------------------------------------------------------------------------------
Bruce D. Brydon (1) 1999 259,273 - - - - - -
Chief Executive 1998 266,033 - - - 2,473,617 -
Officer 1997 232,805 20,970 - - - 453,751 -
- -----------------------------------------------------------------------------------------------------------------------
Robert A. Podruzny(1) 1999 221,728 20,759 - 60,000 - -
President, Chief 1998 134,700 25,754 - - - -
Operating Officer 1997 126,895 15,937 - 42,000 - -
-
-
- -----------------------------------------------------------------------------------------------------------------------
Kenneth C. 1999 207,870 - - 60,000 - -
Cancellara (1) 1998 168,375 - - - - 2,957,262 -
Senior Vice 1997 183,138 - - - - -- -
President and
General Counsel
- -----------------------------------------------------------------------------------------------------------------------
Rolf K. Reininghaus 1999 158,495 34,601 - 60,000 - -
(1) Senior 1998 118,536 - - - 6,108,192 -
Vice-President 1997 134,577 10,654 - - - - -
- -----------------------------------------------------------------------------------------------------------------------
</TABLE>
44
<PAGE>
(1) The amount of compensation paid to the Named Executive Officers was
determined and paid by the Company. Other than in respect of Mr. Melnyk,
these amounts were paid in Canadian dollars and, for the purposes of this
table, converted to U.S. dollars at the respective year end rates of
exchange as follows: 1999 - .6929; 1998 - .6735; and 1997 - .6990.
(2) Perquisites and other personal benefits for Named Executive Officers did
not exceed the minimum threshold disclosure level in 1999.
(3) The options are all for purchase of common shares of the Company and were
granted under the Company's Stock Option Plan, as amended, established in
1993. With the exception of certain options granted in December 1999, all
options are for a term of 5 years and become exercisable as to a maximum of
33 1/3% on each of the first, second and third anniversaries of the date of
grant. 120,000 options were granted in December 1999 and are for a term of
7 years and become exercisable during a period commencing 12 to 15 months
from the date of grant.
(4) The compensation of all officers and directors as a group for the year
ended December 31, 1999 was $1,984,943.
EMPLOYMENT AGREEMENTS
Eugene Melnyk, as Chairman of the Board of the Company, pursuant to a Management
Agreement, effective February 1, 1992, receives annual compensation for services
in the amount of $398,601, which amount is subject to 10% annual increases
during the term of the Management Agreement, and is reimbursed for business
related expenses. The Management Agreement will continue automatically for
renewal periods of one year unless terminated by either party upon prior written
notice.
Bruce Brydon, as Chief Executive Officer and Director, pursuant to an Employment
Agreement effective January 1, 1999, receives an annual salary of Cdn$434,500
plus business expenses. The Employment Agreement is terminable by the Company
and/or Mr. Brydon upon 90 days' written notice.
Robert Podruzny, President, Chief Operating Officer and Director, pursuant to an
Employment Agreement made as of January 8, 1996, receives an annual salary of
Cdn$320,000, subject to a cost of living adjustment, reimbursement of business
expenses and an automobile allowance. The Employment Agreement is terminable by
the Company, and/or Mr. Podruzny upon three months' written notice.
Kenneth Cancellara, as Senior Vice President, General Counsel and Director,
pursuant to an Employment Agreement made as of January 10, 1996, receives an
annual salary of Cdn$300,000, subject to a cost of living adjustment,
reimbursement of business expenses and an automobile allowance. The Employment
Agreement has a term of five years, expiring in March, 2001 and thereafter is
terminable by the Company upon six months' written notice and is terminable by
Mr. Cancellara upon 90 days' prior notice.
Rolf Reininghaus, as Senior Vice President and Director, pursuant to an
Employment Agreement made as of February 1, 1992, as amended, receives an annual
salary of Cdn$228,742, subject to a cost of living adjustment, a bonus at the
discretion of the Board of Directors, as well as reimbursement of business
expenses and an automobile allowance. The Employment Agreement, is terminable by
the Company upon one year's written notice and is terminable by Mr. Reininghaus
upon two months' prior written notice.
45
<PAGE>
DIRECTORS' AND OFFICERS' LIABILITY INSURANCE
The Company maintains insurance for the benefit of its directors and officers
against certain liabilities incurred by them in their capacity as directors or
officers of the Company or its subsidiaries in the aggregate amount of
$15,000,000. The policy governing such insurance is subject to standard
exclusions and limitations. During the 1999 fiscal year the amount of the
premiums paid in respect of such insurance was US$54,648.
REMUNERATION OF DIRECTORS
Certain directors who are not officers or employees of the Company receive an
annual fee of $2,900 and a participation fee of $370 for each meeting of the
Board of Directors attended. All directors are reimbursed for expenses incurred
in connection with attending Board of Directors meetings. Directors also have
been granted stock options pursuant to the terms of the Company's Stock Option
Plan
COMPENSATION COMMITTEE
The Company does not have a compensation committee. The duties of such a
committee are carried out by the Board of Directors. The Board of Directors
meets on compensation matters as and when required with respect to executive
compensation.
PENSION PLAN
The Company does not maintain a pension plan for its employees, officers or
directors.
ITEM 12. OPTIONS TO PURCHASE SECURITIES FROM THE COMPANY OR SUBSIDIARIES
STOCK OPTION PLAN
Under the Company's Stock Option Plan, as amended, (the
"Plan") established in 1993 and approved by the shareholders at the Special
Meeting held on March 28, 1994, the Company may grant to directors, officers,
key employees, consultants and advisors, options to purchase Common Shares of
the Company. The purpose of the Plan is to provide incentives to certain of the
Company's directors, officers, key employees, consultants and advisors. The
aggregate number of shares reserved for issuance under the Plan, taking into
consideration the 2 for 1 stock split, shall not exceed 14,000,000 Common
Shares. The number of shares reserved for issuance to any one person under the
Plan together with shares which that person may acquire under any similar plan
of the Company may not exceed 5% of the total issued and outstanding Common
Shares. Under the Plan, the Company designates the maximum number of shares that
are subject to an option. The exercise price per share of an option is the
closing market price at which the shares are traded on the New York Stock
Exchange on the day prior to the date the option is granted, or if not so
traded, the average between the closing bid and ask prices thereof as reported
for that day.
As at March 31, 2000, the Company has granted an aggregate of
5,068,680 options which are outstanding at exercise prices ranging from $10.00
to $45.00 per share. The options are exercisable up to dates between December
19, 2000 and March 24, 2007.
The following table provides information on the aggregate options exercised
during 1999 and held at the end of 1999 by the Named Executive Officers.
46
<PAGE>
AGGREGATE OPTIONS EXERCISED IN LAST FISCAL YEAR AND OPTION VALUES
<TABLE>
<CAPTION>
- ------------------------------------------------------------------------------------------------------------------------
Unexercised Options Value of Unexercised
at Fiscal Year-End in-the-Money Options
Securities Aggregate Exercisable/ Fiscal Year-End
Acquired on Value Unexercisable Exercisable/ Unexercisable
Exercise Realized (#) (1)(2)
Name (#) (U.S.$) (U.S.$)
- ------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Eugene N. Melnyk - - 1,530,000 / 660,000 50,478,750 / 18,667,500
- ------------------------------------------------------------------------------------------------------------------------
Bruce D. Brydon 212,000 3,259,500 88,000 / 0 3,245,000 / 0
- ------------------------------------------------------------------------------------------------------------------------
Robert A. Podruzny 82,400 1,094,900 21,600 / 148,000 796,500 / 2,757,500
- ------------------------------------------------------------------------------------------------------------------------
Kenneth C. Cancellara 36,700 564,263 63,300 / 120,000 2,334,188/ 1,725,000
- ------------------------------------------------------------------------------------------------------------------------
Rolf K. Reininghaus - 210,000/ 120,000 7,743,750/ 1,725,000
- ------------------------------------------------------------------------------------------------------------------------
</TABLE>
(1) Value of unexercised in-the-money options calculated using the closing price
of common shares of the Company, on the New York Stock Exchange on December
31, 1999 (U.S.$46.88), less the exercise price of in-the-money options.
(2) The options were granted under the Plan, as amended, established in
1993. With the exception of 120,000 options granted in December 1999,
all options are for a term of 5 years and become exercisable as to a
maximum of 33 1/3% on each of the first, second and third anniversaries
of grant. 120,000 options were granted in December 1999 and are for a
term of 7 years and become exercisable during a period commencing 12 to
15 months from the date of grant.
EMPLOYEE STOCK PURCHASE PLAN
The Company's Employee Stock Purchase Plan ("EPP") was established in 1997 and
approved by the shareholders at the Special Meeting held on January 1, 1996. The
purpose of the EPP is to provide a convenient method for full-time employees of
the Corporation to participate in the share ownership of the Corporation or to
increase their share ownership in the Corporation via payroll or contractual
deduction. Directors, senior officers or insiders of the Corporation are not
eligible to participate in the EPP. The aggregate number of shares reserved for
issuance under the Plan, taking into considertation the 2 for 1 stock split in
December, 1999, shall not exceed 600,000 Common Shares. At the discretion of a
committee of the board of directors that will administer the EPP, the
Corporation may issue shares directly from treasury or purchase shares in the
market from time to time to satisfy the obligation under the EPP. A participant
may authorize a payroll or contractual deduction up to a maximum of 10% of the
base salary or remuneration to be received during any purchase period. The
purchase price shall be 90% of the fair value per share of stock on the date on
which the eligible period ends.
As of March 31, 2000 the Company had issued 12,379 shares pursuant to the Plan,
of which 3,078 were issued in 1999 and 781 in 2000.
47
<PAGE>
PERFORMANCE GRAPH
The following graph compares the yearly percentage change in the cumulative
shareholder return on the Company's common shares compared to the cumulative
total return of the Toronto Stock Exchange 300 Index for the past five years,
assuming Cdn$100 investment on December 31, 1994.
[GRAPHIC]
<TABLE>
<CAPTION>
=====================================================================================================================
As at December 31, 1994 1995 1996 1997 1998 1999
=====================================================================================================================
<S> <C> <C> <C> <C> <C> <C>
Biovail Common 100.00 974.42 972.56 1,534.88 1,618.60 3,767.44
=====================================================================================================================
TSE 300 Index 100.00 114.53 146.99 169.01 166.33 219.08
=====================================================================================================================
</TABLE>
ITEM 13. INTEREST OF MANAGEMENT IN CERTAIN TRANSACTIONS
INDEBTEDNESS OF EXECUTIVE OFFICERS
At December 31, 1998, Executive Stock Purchase Plan ("ESPP") loans of
$2,924,000, made to finance the acquisition of shares of the Company on the open
market by executive officers, were outstanding. The ESPP loans were secured by
shares of the Company owned by executive officers, and bore interest at 1/4%
over bank prime rate, equal to the Company's rate for borrowings. The loans were
repaid during 1999.
48
<PAGE>
TABLE OF INDEBTEDNESS
UNDER EXECUTIVE STOCK PURCHASE PLAN
<TABLE>
<CAPTION>
- -------------------------------------------------------------------------------------------------------------------------
Largest Amount Financially
Amount Outstanding Assisted
Involvement Outstanding as at March Securities
Name and Principal Position of Issuer or during 1999 31, 2000 Purchased Security for
Subsidiary (U.S. $) (U.S. $) (#) Indebtedness
- -------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Eugene N. Melnyk Lender 815,117 - 48,000 48,000
Chairman of the Board common shares
- -------------------------------------------------------------------------------------------------------------------------
Robert A. Podruzny Lender 756,374 - 44,700 44,700
President, and Chief Operating common shares
Officer
- -------------------------------------------------------------------------------------------------------------------------
Kenneth C. Cancellara Lender 742,395 - 44,700 44,700
Senior Vice President and General common shares
Counsel
- -------------------------------------------------------------------------------------------------------------------------
Rolf K. Reininghaus Lender 756,374 - 44,700 44,700
Senior Vice President, common shares
President, Crystaal
- -------------------------------------------------------------------------------------------------------------------------
</TABLE>
PART II
ITEM 14 (NOT APPLICABLE)
PART III
ITEM 15 (NOT APPLICABLE)
ITEM 16 CHANGES IN SECURITIES, CHANGES IN SECURITY FOR REGISTERED SECURITIES
AND USE OF PROCEEDS
On December 31, 1999 we filed Articles of Amendment to effect a
subdivision of our common shares on the basis of two common shares for every one
common share held and an increase in our authorized capital from 120,000,000
common shares to an unlimited number of common shares. An amendment was also
made to our current by-law to change the quorum requirements for shareholders
meetings from two shareholders holding 51% of the outstanding shares to two
shareholders holding 25% of the outstanding shares.
PART IV
ITEM 17 FINANCIAL STATEMENTS
The Company has elected to provide financial statements pursuant to Item 18.
49
<PAGE>
ITEM 18. FINANCIAL STATEMENTS
The financial statements filed as part of this Annual Report are listed in
Item 19. Financial Statements and Exhibits.
All financial statements herein, are stated in accordance with
generally accepted accounting principles in Canada and have been reconciled
to United States GAAP. The table of contents to the consolidated financial
statements and accompanying notes to the consolidated financial statements
appears on page F-1 of the Report on Form 20-F.
ITEM 19. FINANCIAL STATEMENTS AND EXHIBITS
(A) FINANCIAL STATEMENTS
o Consolidated Balance Sheets of the Company as at December 31, 1999 and 1998 o
Consolidated Statements of Income and Retained Earings (Deficit) for the years
ended o December 31, 1999, 1998 and 1997 o Consolidated Statements of Cash Flows
for the years ended December 31, 1999, 1998 and 1997 o Notes to the Consolidated
Financial Statements
(B) EXHIBITS FILED WITH THIS SUBMISSION
1.1 Amendment to By-Laws of the Company to change quorum requirements for
meetings of shareholders of the Corporation, dated December 30, 1999
1.2 Conforming Copy of Amended By-Laws of the Company effective December 30,
1999
1.3 Articles of Amendment dated December 31, 1999 effecting a stock split and
an increase in the authorized share capital of the Company*
1.4 Articles of Amalgamation dated February 18, 2000 effecting a change in
the name of the Company*
4.1 Consent of Ernst & Young LLP
4.2 Consent of Deloitte & Touche LLP
- -------------------------------------------------------------------------------
* Incorporated by reference to Registrant's Registration Statement on
Form 8-A, filed with the SEC on March 17, 2000, File No. 001 - 14956.
50
<PAGE>
SIGNATURES
Pursuant to the requirements of Section 12 of the Securities Exchange Act of
1934, the Company certifies that it meets all of the requirements for filing on
Form 20-F and has duly caused this Annual Report to be signed on its behalf by
the undersigned, thereunto duly authorized.
BIOVAIL CORPORATION
/S/ KENNETH G. HOWLING
----------------------------
Kenneth G. Howling
Vice President, Finance and
Chief Financial Officer
Date: April 19, 2000
51
<PAGE>
EXHIBIT INDEX
1.1 Amendment to By-Laws of the Company to change quorum requirements for
meetings of shareholders of the Corporation, dated December 30, 1999
1.2 Conforming Copy of Amended By-Laws of the Company effective December 30,
1999
1.3 Articles of Amendment dated December 31, 1999 effecting a stock split and
an increase in the authorized share capital of the Company*
1.4 Articles of Amalgamation dated February 18, 2000 effecting a change in
the name of the Company*
4.1 Consent of Ernst & Young LLP
4.2 Consent of Deloitte & Touche LLP
- -------------------------------------------------------------------------------
*Incorporated by reference to Registrant's Registration Statement on Form 8-A,
filed with the SEC on March 17, 2000, File No. 001 - 14956.
52
<PAGE>
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
PAGE
--------
<S> <C>
BIOVAIL CORPORATION
Report of Management...................................... F-2
Auditors' Report.......................................... F-3
Consolidated Balance Sheets as at December 31, 1999 and
1998.................................................... F-5
Consolidated Statements of Income and Retained Earnings
for the years ended December 31, 1999, 1998 and 1997.... F-6
Consolidated Statements of Cash Flows for the years ended
December 31, 1999, 1998 and 1997........................ F-7
Notes to the Consolidated Financial Statements............ F-8
</TABLE>
F-1
<PAGE>
REPORT OF MANAGEMENT
The Company's management is responsible for preparing the accompanying
consolidated financial statements in conformity with accounting principles
generally accepted in Canada. The effect of the application of accounting
principles generally accepted in the United States is described in the notes to
consolidated financial statements. In preparing these consolidated financial
statements, management selects appropriate accounting policies and uses its
judgment and best estimates to report events and transactions as they occur.
Management has determined such amounts on a reasonable basis in order to ensure
that the financial statements are presented fairly, in all material respects.
Financial data included throughout this Annual Report is prepared on a basis
consistent with that of the financial statements.
The Company maintains a system of internal accounting controls designed to
provide reasonable assurance, at a reasonable cost, that assets are safeguarded
and that transactions are executed and recorded in accordance with the Company's
policies for doing business. This system is supported by written policies and
procedures for key business activities; the hiring of qualified, competent
staff; and by a continuous planning and monitoring program.
Ernst & Young LLP has been engaged by the Company's shareholders to audit
the consolidated financial statements. During the course of their audit,
Ernst & Young LLP reviewed the Company's system of internal controls to the
extent necessary to render their opinion on the consolidated financial
statements.
The Board of Directors is responsible for ensuring that management fulfills
its responsibility for financial reporting and is ultimately responsible for
reviewing and approving the financial statements. The Board carries out the
responsibility principally through its Audit Committee. The majority of the
members of the Audit Committee are outside Directors. The Committee considers,
for review by the Board of Directors and approval by the shareholders, the
engagement or reappointment of the external auditors. Ernst & Young LLP has full
and free access to the Audit Committee.
Management acknowledges its responsibility to provide financial information
that is representative of the Company's operations, is consistent and reliable,
and is relevant for the informed evaluation of the Company's activities.
<TABLE>
<S> <C>
/s/ EUGENE N. MELNYK /s/ KENNETH G. HOWLING
Eugene N. Melnyk Vice President, Finance
Chairman of the Board and Chief Financial Officer
</TABLE>
F-2
<PAGE>
AUDITORS' REPORT
To the Board of Directors of Biovail Corporation
We have audited the consolidated balance sheet of Biovail Corporation as at
December 31, 1999 and the consolidated statements of income and retained
earnings and cash flows for the year then ended. These financial statements are
the responsibility of the Company's management. Our responsibility is to express
an opinion on these financial statements based on our audit.
We conducted our audit in accordance with auditing standards generally
accepted in Canada. Those standards require that we plan and perform an audit to
obtain reasonable assurance whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant estimates
made by management, as well as evaluating the overall financial statement
presentation.
In our opinion, these consolidated financial statements present fairly, in
all material respects, the financial position of the Company as at December 31,
1999 and the results of its operations and its cash flows for the year then
ended in accordance with accounting principles generally accepted in Canada.
/s/ ERNST & YOUNG LLP
ERNST & YOUNG LLP
Chartered Accountants
Toronto, Canada,
February 29, 2000
F-3
<PAGE>
AUDITORS' REPORT
To the Board of Directors of BIOVAIL CORPORATION
We have audited the consolidated balance sheets of Biovail Corporation as at
December 31, 1998 and the consolidated statements of income and retained
earnings and cash flows for each of the years in the two year period ended
December 31, 1998. These financial statements are the responsibility of the
Company's management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with generally accepted auditing
standards in Canada. Those standards require that we plan and perform an audit
to obtain reasonable assurance whether the financial statements are free of
material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit
also includes assessing the accounting principles used and significant estimates
made by management, as well as evaluating the overall financial statement
presentation.
In our opinion, these consolidated financial statements present fairly, in
all material respects, the financial position of the Company as at December 31,
1998 and the results of its operations and its cash flows for each of the years
in the two year period ended December 31, 1998 in accordance with generally
accepted accounting principles in Canada.
/s/ DELOITTE & TOUCHE LLP
DELOITTE & TOUCHE LLP
Chartered Accountants
Toronto, Canada
May 14, 1999
F-4
<PAGE>
BIOVAIL CORPORATION
CONSOLIDATED BALANCE SHEETS
AS AT DECEMBER 31, 1999 AND 1998
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
ASSETS
CURRENT
Cash and cash equivalents (Note 4)........................ $178,086 $ 78,279
Short-term investments (Note 5)........................... 65,893 --
Accounts receivable (Note 6).............................. 60,571 42,768
Inventories (Note 7)...................................... 12,701 10,542
Assets held for disposal (Note 3)......................... 20,000 --
Executive stock purchase plan loans (Note 8).............. -- 2,924
Deposits and prepaid expenses............................. 3,172 3,357
-------- --------
340,423 137,870
LONG-TERM INVESTMENTS (Note 9).............................. 12 10,055
CAPITAL ASSETS, net (Note 10)............................... 45,300 23,677
OTHER ASSETS, net (Note 11)................................. 249,402 28,317
-------- --------
$635,137 $199,919
======== ========
LIABILITIES
CURRENT
Accounts payable.......................................... $ 22,685 $ 12,244
Accrued liabilities (Note 12)............................. 31,107 4,129
Income taxes payable...................................... 3,585 1,004
Customer prepayments...................................... 4,962 4,516
Current portion of long-term debt (Note 13)............... 12,016 653
-------- --------
74,355 22,546
LONG-TERM DEBT (Note 13).................................... 125,488 126,182
-------- --------
199,843 148,728
-------- --------
SHAREHOLDERS' EQUITY
Share capital (Note 14)................................... 368,538 19,428
Warrants (Note 14)........................................ 8,244 8,244
Retained earnings......................................... 57,252 24,748
Cumulative translation adjustment......................... 1,260 (1,229)
-------- --------
435,294 51,191
-------- --------
$635,137 $199,919
======== ========
Commitments and contingencies (Note 20)
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
On behalf of the Board:
<TABLE>
<S> <C>
/s/ EUGENE N. MELNYK /s/ BRUCE D. BRYDON
------------------------------------------- -------------------------------------------
Eugene N. Melnyk Bruce D. Brydon
CHAIRMAN OF THE BOARD DIRECTOR AND CHIEF EXECUTIVE OFFICER
</TABLE>
F-5
<PAGE>
BIOVAIL CORPORATION
CONSOLIDATED STATEMENTS OF INCOME AND RETAINED EARNINGS
FOR THE YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997
(ALL DOLLAR AMOUNTS EXCEPT PER SHARE DATA ARE EXPRESSED IN THOUSANDS OF
U.S. DOLLARS)
<TABLE>
<CAPTION>
1999 1998 1997
---------- ---------- ----------
<S> <C> <C> <C>
REVENUE
Product sales............................................. $ 99,526 $ 69,154 $ 50,333
Research and development.................................. 52,260 32,070 19,559
Royalty and licensing..................................... 24,706 11,612 12,487
---------- ---------- ----------
176,492 112,836 82,379
---------- ---------- ----------
EXPENSES
Cost of goods sold........................................ 35,078 28,593 16,471
Research and development.................................. 33,130 17,490 14,386
Selling, general and administrative....................... 29,602 17,450 13,831
---------- ---------- ----------
97,810 63,533 44,688
---------- ---------- ----------
OPERATING INCOME............................................ 78,682 49,303 37,691
EQUITY LOSS (Note 3)........................................ (1,618) -- --
INTEREST EXPENSE, net (Note 13)............................. (9,152) (1,702) (351)
GAIN ON DISPOSAL OF LONG-TERM INVESTMENTS, net.............. 1,948 -- --
---------- ---------- ----------
INCOME BEFORE INCOME TAXES AND GOODWILL AMORTIZATION........ 69,860 47,601 37,340
PROVISION FOR INCOME TAXES (Note 16)........................ 4,215 2,024 1,941
---------- ---------- ----------
INCOME BEFORE GOODWILL AMORTIZATION......................... 65,645 45,577 35,399
GOODWILL AMORTIZATION, net of tax........................... 3,165 158 158
---------- ---------- ----------
NET INCOME.................................................. 62,480 45,419 35,241
RETAINED EARNINGS, BEGINNING OF YEAR........................ 24,748 49,709 22,712
EXCESS OF COST OF COMMON SHARES ACQUIRED OVER THE STATED
CAPITAL THEREOF (Note 14)................................. (29,976) (70,380) --
CONTRIBUTION TO INTELLIGENT POLYMERS LIMITED (Note 14)...... -- -- (8,244)
---------- ---------- ----------
RETAINED EARNINGS, END OF YEAR.............................. $ 57,252 $ 24,748 $ 49,709
========== ========== ==========
EARNINGS PER SHARE BEFORE GOODWILL AMORTIZATION............. $ 1.28 $ 0.86 $ 0.69
GOODWILL AMORTIZATION PER SHARE............................. 0.06 0.01 --
---------- ---------- ----------
EARNINGS PER SHARE (Note 15)................................ $ 1.22 $ 0.85 $ 0.69
========== ========== ==========
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
(Note 15)................................................. 51,271,000 53,282,000 51,212,000
========== ========== ==========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
F-6
<PAGE>
BIOVAIL CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 1999, 1998 AND 1997
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
1999 1998 1997
-------- -------- --------
<S> <C> <C> <C>
NET INFLOW (OUTFLOW) OF CASH RELATED TO THE FOLLOWING
ACTIVITIES
OPERATING
Net income for the year................................... $ 62,480 $ 45,419 $ 35,241
Depreciation and amortization............................. 10,140 4,957 3,157
Gain on disposal of long-term investments, net
(Note 9)................................................ (1,948) -- --
Equity loss (Note 3)...................................... 1,618 -- --
-------- -------- --------
72,290 50,376 38,398
Change in non-cash operating items (Note 18)................ 8,723 3,197 (34,082)
-------- -------- --------
81,013 53,573 4,316
-------- -------- --------
INVESTING
Additions to capital assets, net.......................... (7,784) (3,744) (2,664)
Repayment (advance) of executive stock purchase plan loans
(Note 8)................................................ 3,100 10 (421)
Acquisition of product rights (Note 11)................... (38,340) (4,000) --
Acquisition of Fuisz Technologies Ltd., net of cash
acquired (Note 3)....................................... (43,720) -- --
Additions to short-term investments, net.................. (54,665) -- --
Decrease (increase) in other assets....................... 25 (176) (86)
Disposal (acquisition) of long-term investments
(Note 9)................................................ 11,991 (10,043) (12)
Acquisition of royalty interest........................... -- (15,000) --
-------- -------- --------
(129,393) (32,953) (3,183)
-------- -------- --------
FINANCING
Repurchase of share capital (Note 14)..................... (30,593) (72,141) --
Issuance of share capital (Note 14)....................... 253,721 3,929 4,464
Repurchase of subordinated convertible debentures......... (74,545) -- --
Reduction in other long-term debt......................... (667) (21,838) (2,202)
Increase in other long-term debt.......................... -- 19,143 373
Issuance of U.S. Senior Notes, net of financing costs..... -- 120,400 --
-------- -------- --------
147,916 49,493 2,635
-------- -------- --------
EFFECT OF EXCHANGE RATE CHANGES ON CASH..................... 271 (109) (19)
-------- -------- --------
INCREASE IN CASH AND CASH EQUIVALENTS....................... 99,807 70,004 3,749
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR................ 78,279 8,275 4,526
-------- -------- --------
CASH AND CASH EQUIVALENTS, END OF YEAR...................... $178,086 $ 78,279 $ 8,275
======== ======== ========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
F-7
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
1. GOVERNING STATUTE AND NATURE OF OPERATIONS
In December 1999, the shareholders of Biovail Corporation International
approved a change in the name of the company to Biovail Corporation.
Biovail Corporation ("Biovail" or the "Company") is incorporated under the
laws of the province of Ontario. The Company is an international
full-service pharmaceutical company engaged in the formulation, clinical
testing, registration and manufacture of drug products utilizing advanced
drug delivery technologies.
2. SIGNIFICANT ACCOUNTING POLICIES
The consolidated financial statements have been prepared in accordance with
generally accepted accounting principles in Canada. The accounting
principles differ in certain respects from generally accepted accounting
principles in the US as described in Note 23.
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of the Company
and those of all its subsidiaries. All significant intercompany transactions
and balances have been eliminated.
USE OF ESTIMATES
In preparing the Company's financial statements, management is required to
make estimates and assumptions that affect the reported amounts of assets
and liabilities, and the disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from
those estimates.
FAIR VALUE OF FINANCIAL INSTRUMENTS
The estimated fair value of all financial assets and liabilities, other than
long-term debt, approximates their carrying values at December 31, 1999 and
1998. Fair value of a financial instrument is defined as the amount at which
the instrument could be exchanged in a current transaction between willing
parties. The fair value of long-term debt is disclosed in Note 13.
REVENUE RECOGNITION
Research and development revenue represents fees earned from third party
customers for services rendered or attainment of development and regulatory
approval milestones, with respect to contract research and product
development done on their behalf.
Revenue from product sales is recognized when the product is shipped to the
customer.
Royalty revenue is recognized on an accrual basis in accordance with
contractual agreements with third parties and is net of amounts payable to
sublicensees.
Licensing revenue is recognized at the date the license is granted unless
there are specific events which must be completed under the terms of the
licensing agreement in which case a portion of the revenue is deferred and
recognized upon the completion of each specific event.
F-8
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
2. SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
RESEARCH AND DEVELOPMENT
The Company's policy is to expense as incurred all research and product
development costs, net of investment tax credits, related to both costs
incurred on its own behalf and on behalf of its third party customers.
Technology acquired from others, which is still in research and development,
is deferred and amortized over management's estimate of its useful life.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents include highly liquid investments with original
maturities of three months or less when purchased.
SHORT-TERM INVESTMENTS
Short-term investments include highly liquid investments with original
maturities greater than three months but less than one year when purchased.
Short-term investments are carried at cost which approximates fair value.
INVENTORIES
Inventories are comprised of raw materials, work in process, and finished
goods which are valued at the lower of cost and replacement cost. Cost is
determined on the first-in, first-out basis.
LONG-TERM INVESTMENTS
Long-term investments are reported at cost less any provision which may be
required to recognize a permanent decline in value.
CAPITAL ASSETS AND RELATED DEPRECIATION
Capital assets are recorded at cost less accumulated depreciation. Annual
rates applied to depreciate the cost of capital assets over their estimated
useful lives using the straight line basis are as follows:
<TABLE>
<S> <C>
Buildings........................... 25 years
Machinery and equipment............. 5-10 years
Other equipment..................... 3-5 years
Leasehold improvements.............. term of lease
</TABLE>
F-9
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
2. SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
OTHER ASSETS
Other assets are amortized on a straight line basis as follows:
<TABLE>
<S> <C>
Goodwill............................ 20 years
Royalty interests................... 15 years
Acquired in-process research and 15 years
development.......................
Core technology..................... 15 years
Workforce........................... 10 years
Product rights...................... 8-15 years
Deferred financing costs............ term of debt
</TABLE>
Goodwill and product rights are evaluated periodically, based on estimated
cash flows computed on a discounted basis and if conditions warrant an
impairment valuation is provided.
Advertising and promotion costs related to new product launches are deferred
and amortized over a one year period commencing at launch date.
REPORTING CURRENCY AND FOREIGN CURRENCY TRANSLATIONS
REPORTING CURRENCY
The Company reports its financial statements in U.S. dollars, while the
currency of measurement for the Company's operations varies depending upon
location.
FOREIGN CURRENCY TRANSACTIONS
Monetary assets and liabilities are translated at the rate of exchange
prevailing at the balance sheet date. Non-monetary assets and liabilities
are translated at historic rates. Revenue and expenses are translated at the
average rate of exchange for the year. Exchange gains and losses are
included in earnings.
SELF-SUSTAINING FOREIGN SUBSIDIARIES
Assets and liabilities of self-sustaining foreign subsidiaries are
translated at the rate of exchange in effect at the balance sheet date.
Revenue and expenses are translated at the average rate of exchange for the
year. Gains or losses arising on the translation of financial statements of
self-sustaining foreign subsidiaries are deferred and included as a separate
component of shareholders' equity. The net change in the cumulative
translation adjustment balance in the years presented is primarily due to
fluctuations in the exchange rate with respect to the Swiss franc, Irish
punt and Canadian dollar.
CUSTOMER PREPAYMENTS
Amounts received from customers as prepayments for goods or services to be
provided in the future are recorded on the balance sheet as customer
prepayments. When the goods or services are provided at a future date, they
are billed to the customer at contractual rates.
F-10
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
2. SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
STOCK OPTION PLAN
The Company has a stock option plan which is described in Note 14. No
compensation expense is recognized for this plan when stock options are
issued to employees. Any consideration paid by employees on the exercise of
stock options is credited to share capital.
INCOME TAXES
The Company follows the deferral method of income tax allocation.
1998 AND 1997 FIGURES
Goodwill amortization and certain other figures for 1998 and 1997 have been
reclassified to conform to the 1999 presentation.
3. ACQUISITION
(i) DESCRIPTION OF ACQUISITION
On November 12, 1999, the Company completed the acquisition of Fuisz
Technologies Ltd. ("Fuisz") for $177,897,000 including costs relating to the
acquisition. Fuisz is an international company that is engaged in the
development, manufacturing and commercialization of a wide range of drug
delivery, nutraceutical and food ingredient products utilizing its
proprietary CEFORM-Registered Trademark-, SHEARFORM-Registered Trademark-
and other drug delivery technologies (the "Fuisz Technology").
Fuisz was acquired through a series of transactions which began in July 1999
with the purchase of certain Fuisz common stock and the announcement on
July 25, 1999 that the Company had entered into a merger agreement to
acquire the remaining common stock of Fuisz in a two-stage transaction
consisting of a cash tender offer and a stock-for-stock merger.
By September 4, 1999, the Company had completed the acquisition of 49% of
Fuisz's outstanding common stock for cash consideration of $75,565,000
pursuant to the cash tender offer and other purchase transactions. On
November 12, 1999, Biovail acquired the remaining common stock of Fuisz by
issuing 1,544,155 pre-split common shares of the Company, which includes
44,155 pre-split common shares to be issued (see Note 14) with a fair value
of $96,006,000. Certain of these common shares are yet to be issued. The
value of the common shares issued by the Company was determined by reference
to the average market price of the Company's stock before and after the
acquisition on November 12, 1999 and after giving effect to normal costs of
issue of shares.
(ii) PURCHASE PRICE ALLOCATION
The Company accounted for the acquisition of Fuisz as a step acquisition
using the purchase method of accounting. The Company has recognized in these
consolidated financial statements its 49% equity interest in the results of
Fuisz for the period from September 4, 1999, the date it acquired
significant influence, to November 12, 1999, the date of acquisition of
control. The assets, liabilities, revenues and expenses of Fuisz have been
included in these consolidated financial statements from November 12, 1999.
F-11
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
3. ACQUISITION (CONTINUED)
The purchase price of $177,897,000 which includes acquisition costs of
$6,326,000 was allocated as follows:
<TABLE>
<S> <C>
Acquired in-process research and development................ $137,470
Current assets.............................................. 60,617
Goodwill.................................................... 37,224
Assets held for disposal.................................... 20,000
Capital assets.............................................. 16,893
Core technology............................................. 11,185
Workforce................................................... 2,041
Other assets................................................ 358
Current liabilities......................................... (21,820)
Debt assumed................................................ (86,071)
--------
Purchase price.............................................. $177,897
========
</TABLE>
(iii) ACQUIRED IN-PROCESS RESEARCH AND DEVELOPMENT
The Fuisz Technology involves drug delivery platforms and the application of
such platforms to specific product development programs. At the date of
acquisition, Fuisz was involved in seventeen product development projects
for a number of pharmaceutical companies which were in various stages of
completion. With the exception of certain nutraceutical products, the Fuisz
Technology has not been employed in any product which has received
regulatory approval to date and was considered to have no alternative future
use other than for the therapeutic indications for which it was in
development or which may be developed. Accordingly, technological
feasibility of the products related to the Fuisz Technology was not
established at the acquisition date and was considered to be in-process
research and development.
Two of the projects have been submitted for approval with the applicable
regulatory authorities. One project was submitted to the Food and Drug
Administration ("FDA") in the US in June 1998 and the other was submitted to
the Medical Control Agency in the UK in April 1998. The remaining fifteen
projects are expected to be completed in accordance with Fuisz's contractual
obligations with the relevant customers over the next eighteen months.
The development projects were estimated to be 65% complete on average,
estimated peak sales were approximately $942 million per annum, estimated
costs to completion of these products were approximately $9.5 million and
discount rates of 28% were used. The average time to full completion of the
remaining work for the projects in development was estimated to be
approximately twelve months. The work remaining to complete the products in
development involved on-going formulation, bioequivalency, safety and
efficacy studies and the submission of regulatory filings to seek marketing
approvals. The principal risks relating to the acquired technology were the
outcomes of such clinical trials and Biovail's ability to negotiate
acceptable commercial terms with the pharmaceutical companies developing the
products. As pharmaceutical products cannot be marketed without regulatory
approvals, the Company will not receive any benefits unless regulatory
approval is obtained.
If the projects currently under development are successful, the Company
expects that the Fuisz Technology will have extended life cycles. Because
the Fuisz Technology is based on drug delivery, the technology can be
applied to numerous products. Although the risk of technological feasibility
is always present in each
F-12
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
3. ACQUISITION (CONTINUED)
product, the Company's strategy is to exploit the technology through
numerous product developments which the Company expects will occur over at
least the next fifteen years.
(iv) ASSETS HELD FOR DISPOSAL
The Company determined, as part of its evaluation of the purchase, that
certain operations of Fuisz were not strategic to Biovail's business plans
and accordingly should be sold.
Prior to the completion of the share exchange, on October 22, 1999, Fuisz
agreed to sell all of the issued shares of three of its wholly owned
European subsidiaries for proceeds of $28,700,000. Further, Fuisz agreed to
assign all of the rights, privileges and advantages from its Cebutid
trademark to the purchaser of its European subsidiaries for proceeds of
$10,273,000. No gain or loss was recognized by the Company on these
transactions as these subsidiaries were included in the purchase price
allocation at their fair value when Biovail acquired its 49% interest in
Fuisz.
On December 1, 1999, Biovail entered into an agreement to sell all of the
issued share capital of Clonmel Healthcare Limited ("Clonmel"), a
pharmaceutical and antibiotic manufacturer and distributor, for proceeds of
$20,000,000. The sale is expected to close in early 2000. No gain or loss
was recognized by the Company on this transaction as this subsidiary was
included at fair value in the purchase price allocation at November 12,
1999.
(v) PRO FORMA INFORMATION
The following unaudited pro forma information presents a summary of
consolidated results of operations of the Company and Fuisz as if the
acquisition, disposals and repayment of convertible subordinated debentures
had occurred January 1, 1998 (a full year of goodwill amortization and
interest cost is included for both 1998 and 1999).
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Total revenue............................................... $188,418 $125,835
Net income (loss)........................................... $ 21,892 $ (3,089)
Earnings (loss) per share (basic)........................... $ 0.39 $ (0.05)
</TABLE>
These unaudited pro forma results have been prepared for comparative
purposes only. They do not purport to be indicative of the results of
operations which actually would have resulted had Fuisz been included in the
Company's consolidated financial statements as of January 1, 1998. In
addition, they do not purport to be indicative of future consolidated
results of operations of the Company.
4. CASH AND CASH EQUIVALENTS
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Cash and bank certificates of deposit..................... $ 38,776 $37,160
Corporate debt securities................................. 139,310 41,119
-------- -------
$178,086 $78,279
======== =======
Corporate debt securities are carried at cost which
approximates fair value.
</TABLE>
F-13
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
5. SHORT-TERM INVESTMENTS
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Corporate debt securities.................................. $54,635 $ --
Restricted cash............................................ 11,258 --
------- -------
$65,893 $ --
======= =======
</TABLE>
Restricted cash is pledged as collateral against an IRL 8,452,000 bank loan
in connection with the 1997 acquisition of Clonmel by Fuisz. Under the terms
of the sale of Clonmel, which is expected to close in early 2000, the
Company will be required to repay the loan. Accordingly, the restricted cash
is shown as a current asset.
6. ACCOUNTS RECEIVABLE
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Trade and royalties........................................ $53,634 $36,638
Other receivables.......................................... 6,937 2,672
Insurance claims recoverable............................... -- 3,458
------- -------
$60,571 $42,768
======= =======
</TABLE>
The Company performs ongoing credit evaluations of customers and generally
does not require collateral. Allowances are maintained for potential credit
losses. At December 31, 1999, three customers accounted for 82% of trade and
royalties receivable. At December 31, 1998, four customers accounted for 60%
of trade and royalties receivables. The Company believes that there is no
unusual exposure associated with the collection of these receivables.
Insurance claims recoverable related to business interruption losses
resulting from insurance damage in Puerto Rico in September 1998.
7. INVENTORIES
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Raw materials.............................................. $ 5,149 $ 4,759
Work in process............................................ 4,258 5,478
Finished goods............................................. 3,294 305
------- -------
$12,701 $10,542
======= =======
</TABLE>
8. EXECUTIVE STOCK PURCHASE PLAN LOANS
At December 31, 1998, Executive Stock Purchase Plan ("ESPP") loans of
$2,924,000, made to finance the acquisition of shares of the Company on the
open market by executive officers, were outstanding. The ESPP loans were
secured by shares of the Company owned by executive officers, and bore
interest at 1/4% over bank prime rate, equal to the Company's rate for
borrowings. The loans were repaid during 1999.
F-14
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
9. LONG-TERM INVESTMENTS
Long-term investments is comprised of 12,000 special shares of Intelligent
Polymers Limited ("IPL"), acquired in 1998. These shares have no entitlement
to profits of IPL.
During 1999 the Company sold certain long-term investments, which had been
acquired in 1998, for a net gain of $1,948,000.
10. CAPITAL ASSETS
<TABLE>
<CAPTION>
1999 1998
----------------------- -----------------------
ACCUMULATED ACCUMULATED
COST DEPRECIATION COST DEPRECIATION
-------- ------------ -------- ------------
<S> <C> <C> <C> <C>
Land................................................ $ 1,270 $ -- $ 1,220 $ --
Buildings........................................... 17,423 3,724 14,972 2,864
Machinery and equipment............................. 24,914 7,366 13,218 4,874
Other equipment and leasehold improvements.......... 15,873 3,090 4,061 2,056
------- ------- ------- ------
59,480 $14,180 33,471 $9,794
======= ======
Less accumulated depreciation....................... 14,180 9,794
------- -------
$45,300 $23,677
======= =======
</TABLE>
11. OTHER ASSETS
The following table summarizes other assets net of accumulated amortization.
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Goodwill.................................................... $ 38,514 $ 3,277
Acquired in-process research and development................ 136,215 --
Core technology and workforce............................... 13,096 --
Product rights and royalty interests........................ 56,945 20,522
Other intangibles........................................... 4,632 4,518
-------- -------
$249,402 $28,317
======== =======
</TABLE>
Amortization amounted to $6,002,000, $1,883,000, and $441,000 in 1999, 1998
and 1997, respectively.
In December 1999, the Company acquired from IPL the product rights to IPL's
generic version of Procardia XL for $25,000,000.
In October 1999, the Company acquired from Elan Corporation plc ("Elan") the
exclusive marketing rights for the US to Elan's generic version of Adalat
CC. The product will be marketed by Teva Pharmaceuticals ("Teva"). The net
cost to the Company was $9,000,000, which will be amortized over the life of
the product.
In November 1998, the Company completed the issue of U.S. Dollar Senior
Notes, due 2005, for gross proceeds of $125,000,000. The expenses associated
with this transaction have been deferred and are being amortized on a
straight-line basis over the seven-year term of the debt.
In March 1998, the Company completed the acquisition of the royalty interest
held by Galephar Puerto Rico, Inc. Limited ("Galephar") in certain of the
Company's products. The Company paid $15,000,000 to Galephar in full
satisfaction of the Company's royalty obligations on the sales of
Tiazac-Registered Trademark- and the Company's generic controlled release
version of Cardizem CD in the US and Canada. In September 1998, the Company
acquired from Centocor, Inc. the exclusive distribution rights in Canada for
Retavase for $4,000,000.
F-15
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
12. ACCRUED LIABILITIES
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
Restructuring costs......................................... $13,597 $ --
Employee costs.............................................. 4,528 836
Professional fees........................................... 2,163 368
Interest.................................................... 1,736 1,715
Royalties................................................... 1,331 594
Product rights.............................................. 1,524 --
Other....................................................... 6,228 616
------- ------
$31,107 $4,129
======= ======
</TABLE>
Restructuring costs accrued in relation to the acquisition of Fuisz
consisted of $11.3 million for the settlement of contracts, $1.5 million for
the termination of employees and $1.3 million of other costs. These costs
were included in the determination of the net assets of Fuisz acquired.
Since the date of acquisition, approximately $534,000 of these costs have
been settled.
Employee costs include $2.5 million of severance pay owing to certain Fuisz
employees terminated prior to the acquisition by Biovail.
13. LONG-TERM DEBT
<TABLE>
<CAPTION>
1999 1998
-------- --------
<S> <C> <C>
NON-INTEREST BEARING GOVERNMENT LOAN
Payable to Western Economic Diversification, a Canadian
federal government agency. This loan is repayable on a
semi-annual installment basis of $381,000 per
installment with the final payment due in 2001.......... $ 1,250 $ 1,835
U.S. DOLLAR SENIOR NOTES, DUE 2005
Issued under an indenture dated November 16, 1998, the
U.S. Dollar Senior Notes are general unsecured senior
obligations of Biovail Corporation bearing interest at
10 7/8%, payable semi-annually in arrears on May 15 and
November 15 of each year. The U.S. Dollar Senior Notes
mature on November 15, 2005............................. 125,000 125,000
TERM BANK LOAN
Term loan payable of IRL 8,452,000 and bears interest at
the bank's reference rate plus margin (aggregate rate
4.13% at December 31, 1999). This loan is collateralized
by a cash balance of $11,258,000 and charges over the
assets of Clonmel....................................... 10,799 --
OTHER DEBT.................................................. 455 --
-------- --------
137,504 126,835
Less current portion........................................ 12,016 653
-------- --------
$125,488 $126,182
======== ========
</TABLE>
F-16
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
13. LONG-TERM DEBT (CONTINUED)
On or after November 15, 2002, the U.S. Dollar Senior Notes will be
redeemable at the option of the Company at the following prices if redeemed
during the twelve months beginning November of the years indicated below:
<TABLE>
<CAPTION>
PERCENTAGE OF PRINCIPAL
YEAR OUTSTANDING
---- -----------------------
<S> <C>
2002.............................................. 105.438%
2003.............................................. 102.719%
2004.............................................. 100.000%
</TABLE>
At any time on or before November 15, 2001, the Company may, at its option,
redeem up to a maximum of 35% of the aggregate principal amount of the U.S.
Dollar Senior Notes with the net cash proceeds of one or more equity
offerings or the net cash proceeds received upon the exercise of warrants to
purchase capital stock of the Company, at a redemption price equal to
110.875% of the principal amount thereof.
At December 31, 1999, the fair value of the U.S. Dollar Senior Notes
approximates its carrying value of $128,388,000. The fair value of the
remaining debt approximates its carrying value.
Interest expense on long-term debt amounted to $13,594,000, $2,358,000 and
$199,000 in the years ended December 31, 1999, 1998 and 1997, respectively.
Principal repayments on long-term debt are as follows:
<TABLE>
<S> <C>
2000....................................................... $ 12,016
2001....................................................... 488
2002....................................................... --
2003....................................................... --
2004....................................................... --
2005....................................................... 125,000
--------
$137,504
========
</TABLE>
Subsequent to the year end, the Company announced a tender for any and all
its outstanding 10 7/8% U.S. Dollar Senior Notes at a redemption price of
110.951% of the principal amount. The initial expiration date for the tender
offer is March 20, 2000. Holders who irrevocably agree to tender on or prior
to March 6, 2000, will receive an additional 2% of the principal amount.
These U.S. Dollar Senior Notes have been classified as long term debt based
on the conditions that existed at the balance sheet date.
14. SHARE CAPITAL
AUTHORIZED AND ISSUED SHARES
In December, 1999, the shareholders of the Company authorized a 2 for 1
stock split to the issued common shares and an increase in authorized shares
from 120,000,000 common shares to an unlimited number of common shares
without par value. All share and per share amounts in these financial
statements have been retroactively adjusted to give effect to the 2 for 1
stock split.
In October 1999, the Company completed a share offering issuing 10,180,000
common shares for gross proceeds of $259 million less costs of $13.5
million.
F-17
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
14. SHARE CAPITAL (CONTINUED)
By resolutions of the Board of Directors dated August 11, 1998, and
November 16, 1998, the Company implemented a stock repurchase program under
which the Company was enabled to purchase up to 10% of its issued and
outstanding common shares. Up to December 31, 1998, 4,543,800 common shares
had been repurchased under this plan at a cost of $72,141,000. The excess of
the cost of the common shares acquired over the stated capital thereof,
totaling $70,380,000, was charged to retained earnings. In 1999, 1,465,400
common shares were repurchased at a cost of $30,593,000. The excess of the
cost of the common shares acquired over the stated capital thereof, totaling
$29,976,000 was charged to retained earnings.
<TABLE>
<CAPTION>
NUMBER OF SHARES AMOUNT
---------------- --------
<S> <C> <C>
(000'S)
Balance, December 31, 1996.................................. 50,854 $ 14,614
Issued on the exercise of options........................... 2,466 4,434
Issued under Employee Stock Purchase Plan................... 2 30
Effect of exchange rate change.............................. -- (613)
------ --------
Balance, December 31, 1997.................................. 53,322 18,465
Issued on the exercise of options........................... 940 3,886
Issued under Employee Stock Purchase Plan................... 4 43
Cancelled under stock repurchase program.................... (4,544) (1,761)
Effect of exchange rate change.............................. -- (1,205)
------ --------
Balance, December 31, 1998.................................. 49,722 19,428
Issued on the exercise of options........................... 668 7,629
Issued under Employee Stock Purchase Plan................... 3 40
Cancelled under stock repurchase program.................... (1,465) (617)
Issued pursuant to equity offering.......................... 10,180 246,052
Issued on Fuisz acquisition(i).............................. 3,088 96,006
------ --------
Balance, December 31, 1999.................................. 62,196 $368,538
====== ========
</TABLE>
----------------------------
(i) Included in the issued and outstanding shares are 88,310 shares to be
issued following the effectiveness of a registration statement with
respect to the Fuisz acquisition.
STOCK OPTION PLAN
Under the Company's Stock Option Plan, as amended, (the "Plan") established
in 1993 and approved by the shareholders at the Special Meeting held on
March 28, 1994, the Company may grant to directors, officers, key employees,
consultants and advisors, options to purchase common shares of the Company.
The purpose of the Plan is to provide long-term incentives and rewards to
certain of the Company's directors, officers, employees, consultants and
advisors. The aggregate number of shares reserved for issuance under the
Plan taking into consideration the 2 for 1 stock split shall not exceed
14,000,000 common shares. The number of shares reserved for issuance to any
one person under the Plan together with shares which that person may acquire
under any similar plan of the Company may not exceed 5% of the total issued
and outstanding common shares. Under the Plan, the Company designates the
maximum number of shares that are subject to an option. The exercise price
per share of an option is the closing market price at which the shares are
traded on the New York Stock Exchange on the day prior to the date the
option is granted, or if not so traded, the average between the closing bid
and ask prices thereof as reported for that day.
F-18
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
14. SHARE CAPITAL (CONTINUED)
The options vesting terms vary as per the type of options. Management
options granted prior to 1999 vest as to one third each year commencing on
the first anniversary of the grant and will expire on a date not later than
five years from the date of the grant.
Options granted in 1999 vest as follows: Executive options vest pursuant to
the terms and conditions of the employment agreement, special options vest
on the second anniversary date of the grant; management options vest as to
one fourth each year commencing on the first anniversary of the grant and
expire not later than seven years from the date of the grant.
The following table summarizes the Company's stock option activity for the
three years ended December 31, 1999 taking into effect the 2 for 1 stock
split in December 1999:
<TABLE>
<CAPTION>
OPTIONS WEIGHTED AVERAGE
(000'S) EXERCISE PRICE
-------- ----------------
<S> <C> <C>
Outstanding Balance, December 31, 1996...................... 5,502 $ 6.57
Granted..................................................... 2,358 15.43
Exercised................................................... (2,466) 1.80
Cancelled................................................... (354) 13.15
------ ------
Outstanding Balance, December 31, 1997...................... 5,040 12.57
Granted..................................................... 602 17.57
Exercised................................................... (940) 4.13
Cancelled................................................... (280) 15.34
------ ------
Outstanding Balance, December 31, 1998...................... 4,422 13.82
Granted..................................................... 1,684 37.15
Exercised................................................... (668) 11.42
Cancelled................................................... (214) 14.75
------ ------
Outstanding Balance, December 31, 1999...................... 5,224 $21.61
====== ======
Exercisable at December 31, 1999............................ 2,367 $13.22
====== ======
</TABLE>
The following table summarizes the information about options outstanding at
December 31, 1999:
<TABLE>
<CAPTION>
OUTSTANDING AVERAGE CONTRACTUAL WEIGHTED
PRICE RANGE OPTIONS LIFE REMAINING AVERAGE PRICE
----------- ----------- ------------------- -------------
<S> <C> <C> <C>
(000'S)
$10 - $15............................................ 1,310 1.4 $11.22
$15 - $20............................................ 2,582 3.2 $16.42
$20 - $30............................................ 170 5.5 $26.57
$30 - $45............................................ 1,162 6.8 $44.14
-----
5,224 3.6 $21.61
=====
</TABLE>
EMPLOYEE STOCK PURCHASE PLAN
The Company's Employee Stock Purchase Plan ("EPP") was approved by the
shareholders at the Special Shareholder Meeting held on January 1, 1996 and
was established in 1996. The purpose of the EPP is to provide a convenient
method for full-time employees of the Company to participate in the share
ownership
F-19
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
14. SHARE CAPITAL (CONTINUED)
of the Company or to increase their share ownership in the Company via
payroll or contractual deduction. Directors, senior officers or insiders of
the Company are not eligible to participate in the EPP. The aggregate number
of shares reserved for issuance under the Plan, taking into consideration
the 2 for 1 stock split in December 1999, shall not exceed 600,000 common
shares. At the discretion of a committee of the Board of Directors that will
administer the EPP, the Company may issue directly from treasury or purchase
shares in the market from time to time to satisfy the obligation under the
EPP. A participant may authorize payroll or contractual deduction up to a
maximum of 10% of the base salary or remuneration to be received during any
purchase period. The purchase price shall be 90% of the fair market value
per share of stock on the date on which the eligible period ends.
WARRANTS
In October, 1997, IPL completed a public offering of 3,737,500 units. Each
unit comprised one common share of IPL and one warrant to purchase two post
split common shares of the Company. The net proceeds to IPL of the offering
before offering expenses amounted to approximately $69,500,000. On
September 30, 1999, the units separated and the IPL common shares and the
Company's warrants now trade independently of each other. The warrants are
exercisable at a per share price of $20.00 from October 1, 1999 until
September 30, 2002.
In 1997, the Company recorded a credit to equity of $8,244,000 equal to the
proceeds attributable to the warrants included in the offering as determined
at the time of their issuance and recorded a charge to retained earnings to
reflect the equivalent contributions to IPL.
15. EARNINGS PER SHARE
Earnings per share, for all years presented, has been calculated using the
weighted average number of common shares outstanding during the year after
giving effect to the 2 for 1 stock split. Earnings per share in 1999, 1998
and 1997 on a fully diluted basis giving effect to the exercise of all
options and warrants granted, would have been $1.09, $0.82 and $0.66 per
share, respectively.
16. INCOME TAXES
The major factors which caused variation from the Company's combined federal
and provincial statutory income tax rate of 44.81% in 1999 and 1998 and
44.34% in 1997, applicable to income before income taxes are as follows:
<TABLE>
<CAPTION>
1999 1998 1997
-------- -------- --------
<S> <C> <C> <C>
Provision for income taxes based on statutory rate.......... $ 31,303 $ 21,258 $ 16,486
Reduction in income taxes resulting from income of foreign
subsidiaries taxed at lower effective rate................ (36,925) (22,970) (14,331)
Benefit of current year losses not recognized for accounting
purposes.................................................. 9,661 3,736 --
Large Corporation Tax....................................... 176 -- --
Benefit of utilization of losses carried forward............ -- -- (214)
-------- -------- --------
$ 4,215 $ 2,024 $ 1,941
======== ======== ========
</TABLE>
F-20
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
16. INCOME TAXES (CONTINUED)
At December 31, 1999, the Company has accumulated non-capital losses for
federal and provincial income tax purposes in Canada and unclaimed Canadian
investment tax credits for which no accounting benefit has been recognized
and which can be used to offset future taxable income and/or reduce income
taxes payable. These losses and investment tax credits expire as follows:
<TABLE>
<CAPTION>
NON-CAPITAL LOSSES
--------------------- INVESTMENT
FEDERAL PROVINCIAL TAX CREDITS
-------- ---------- -----------
<S> <C> <C> <C>
2000........................................................ $ -- $ 3,791 $ 470
2001........................................................ -- 3,263 454
2002........................................................ -- 1,173 432
2003........................................................ -- 2,896 137
2004........................................................ 50 119 436
2005........................................................ 4,956 5,271 505
2006........................................................ -- 6,042 1,129
2007........................................................ -- -- 1,600
2008........................................................ -- -- 2,053
2009........................................................ -- -- 3,217
------ ------- -------
$5,006 $22,555 $10,433
====== ======= =======
</TABLE>
The benefits of these losses carried forward and investment tax credits will
be recorded when realized.
As of December 31, 1999, the Company has available net operating loss carry
forwards in the US of approximately $75,375,000. These losses, which are
subject to restrictions, expire at various dates as follows:
<TABLE>
<CAPTION>
NET OPERATING
LOSSES
<S> <C>
2003........................................................ $ 113
2004........................................................ 165
2005........................................................ 564
2006........................................................ 64
2007........................................................ 4,507
2008........................................................ 6,068
2009........................................................ 6,746
2010........................................................ 3,109
2011........................................................ 16,424
2012........................................................ 15,483
2018........................................................ 22,132
-------
$75,375
=======
</TABLE>
In addition, the Company has pooled research and development expenditures
amounting to approximately $34,000,000 available for offset against future
taxable income. The tax benefit of these expenditures has not been
recognized in these financial statements.
F-21
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
17. OPERATING LEASES
Minimum lease commitments under operating leases for each of the next five
years are as follows:
<TABLE>
<CAPTION>
<S> <C>
2000..................................................... $4,795
2001..................................................... 4,376
2002..................................................... 2,907
2003..................................................... 1,228
2004..................................................... 1,258
Thereafter............................................... 958
</TABLE>
18. CHANGE IN NON-CASH OPERATING ITEMS
<TABLE>
<CAPTION>
1999 1998 1997
------- -------- --------
<S> <C> <C> <C>
Accounts receivable......................................... $(9,973) $(10,036) $(23,145)
Inventories................................................. (1,560) 6,307 (8,622)
Deposits and prepaid expenses............................... 693 (1,304) (991)
Accounts payable and accrued liabilities.................... 16,613 5,563 3,315
Income taxes payable........................................ 2,604 (9) 201
Customer prepayments........................................ 346 2,676 (4,840)
------- -------- --------
$ 8,723 $ 3,197 $(34,082)
======= ======== ========
</TABLE>
19. INTEREST AND INCOME TAXES PAID
<TABLE>
<CAPTION>
1999 1998 1997
-------- -------- --------
<S> <C> <C> <C>
Interest paid............................................... $14,526 $1,050 $ 691
Income taxes paid........................................... 1,831 2,153 1,736
</TABLE>
20. LEGAL PROCEEDINGS
In January, 1998, Andrx Pharmaceutical, Inc. ("Andrx") commenced action
against the FDA, Faulding Inc., and Biovail seeking an order from the Court
which would preclude the FDA from approving any subsequently-filed ANDAs,
including the Company's filed ANDA for a generic version of Cardizem CD
until Andrx receives from the FDA thirty days' prior notice of the FDA's
intention to approve any such subsequently filed ANDA. Such notice would
allow Andrx to attempt to seek court relief based on its position that as a
first filer it is entitled to 180 days of market exclusivity. Biovail has
asserted affirmative defenses based upon the Company's status as an unsued
ANDA submitter. Biovail has also counter-sued Andrx for anti-trust law
violations based on the filing of this suit and Andrx' entry into an alleged
collusive agreement with Hoechst Marion Roussel relating to Andrx' generic
Cardizem CD which could result in keeping generic competition from entering
the marketplace in a regular and timely manner. The FDA has filed a motion
seeking summary dismissal of Andrx' action. Andrx has filed its own motion
to have its action dismissed, however, Biovail did not withdraw the
Company's counterclaim because the issues that were the subject of Andrx'
action have now overtaken the timelines contemplated in the action (Andrx
and Biovail have both launched their respective generic versions of Cardizem
CD and Andrx' main action was dismissed), Biovail's counterclaim has been
dismissed. Biovail has nevertheless launched an appeal to the
F-22
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
20. LEGAL PROCEEDINGS (CONTINUED)
dismissal of its counterclaim even though Andrx' main action against the FDA
and Biovail has long since been terminated.
In March, 1998, Biovail commenced an action in the District of New Jersey
against Hoechst Aktiengesellschaft and related parties to recover three
times the Company's monetary damages and for injunctive relief for the
alleged violation by the defendants of the anti-trust laws of the United
States, for breach of contract, deceptive trade practices and restraint of
trade, unfair competition and other violations for the common law. A
reasonable estimation of the Company's potential recovery for damages cannot
be made at this time.
From time to time, Biovail becomes involved in various legal proceedings
which Biovail considers to be in the ordinary course of business. The vast
majority of these proceedings involve intellectual property issues that
often result in patent infringement suits brought by patent holders upon the
Company's filing of ANDA applications. The timing of these actions is
mandated by statute and may result in a delay of FDA's approval for such
filed ANDAs until the final resolution of such actions or the expiry of
30 months, whichever occurs earlier.
In this regard, Biovail and the Company's wholly owned subsidiary Biovail
Laboratories, Inc. ("Biovail Laboratories"), have been sued in separate
lawsuits by Bayer AG and Bayer Corporation, as well as by Pfizer, Inc., upon
the filing by Biovail Laboratories of separate ANDAs for generic versions of
Procardia XL and Adalat CC. These actions make the usual, technical claims
of infringement that, if successful, mandate a delay for the approval of the
Company's ANDAs for a period of 30 months or until successful resolution of
these patent infringement questions, whichever occurs first. Biovail
Laboratories is vigorously defending these suits and will aggressively
pursue motions for summary judgment in due course.
These four actions have been consolidated into two actions by the court.
Biovail has denied the allegations and has pleaded affirmative defences that
the patents are invalid, have not been infringed, and unenforceable.
On April 23, 1998, Biovail also filed a four-count Complaint against Bayer
AG, Bayer Corporation and Pfizer Inc. seeking a declaratory judgment that
their patents are invalid, unenforceable, and not infringed by the Company's
ANDAs. Biovail intends to amend the Complaint in due course to assert that
their patent has not been infringed by the filing of all four ANDAs by
Biovail Laboratories Inc. Biovail has also asserted that Bayer Corporation
and Pfizer Inc. have violated anti-trust laws and have interfered with the
Company's prospective economic advantage. Bayer and Pfizer have filed a
motion to dismiss the anti-trust and interference counts but that action has
been stayed pending the conclusion of the main actions.
On August 25, 1998, Andrx submitted to Biovail a Notice of Certification
under the FDC Act wherein it certified that the ANDA filed by Andrx for a
generic version of Tiazac did not infringe on the Company's Patent. As a
result, in October 1998, Biovail commenced a patent infringement suit
against Andrx. The FDA cannot approve Andrx's ANDA for a period of up to
30 months from the filing of the Company's suit or the date when Andrx
successfully defends the Company's patent infringement suit, whichever first
occurs. The trial of this action was recently completed but no judicial
decision has been released.
While Biovail is not currently able to determine the potential liability, if
any, related to such matters, Biovail believes none of the matters,
individually or in aggregate, will have a material adverse effect on the
Company's financial position, results of operations or cash flows.
F-23
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
20. LEGAL PROCEEDINGS (CONTINUED)
In January 2000, Biovail Technologies Ltd. ("BTL"), commenced a suit against
Dr. Richard Fuisz, the founder and former chairman of Fuisz--now BTL,
Patrick Scrivens (the former CFO of Fuisz), Paul Kennedy (a former officer
of Fuisz and Manager of Fuisz's European subsidiaries), John Fuisz (a former
Board member of Fuisz) and others, in which a claim for damages has been
asserted, resulting from a number of specific breaches. The Company believes
it has meritorious claims.
In the ordinary course of business from time to time the Company becomes
involved in normal litigation reflective commercial or employment disputes.
The Company is not aware of any action, commenced or threatened, that are
discussed above or in combination has or may have a material impact on the
Company or the Company's operations.
21. RESEARCH AND DEVELOPMENT ARRANGEMENTS
IPL
IPL was formed by the Company in July, 1997. In September, 1997, the Company
concluded a development and license agreement (the "Development Contract")
and a services agreement (the "Services Agreement") with IPL, whereby the
Company develops on IPL's behalf once-daily controlled release branded
generic versions of designated products. In October, 1997, IPL completed a
public offering of 3,737,500 units resulting in net proceeds to IPL, before
offering expenses, of approximately $69,500,000.
The proceeds of the offering are being used by IPL primarily to make
payments to the Company under the Development Contract. The Development
Contract provides for the Company to conduct product development in respect
of certain designated products. Such costs are being computed with respect
to internal costs incurred by the Company at its fully absorbed cost plus a
mark-up, consistent with contractual relationships the Company has with
other third parties.
Revenue received by the Company from IPL pursuant to the Development
Contract, was $33.0 million, $9.7 million and $9.6 million for 1999, 1998
and 1997 respectively. The cost of providing these services amounted to
$19.8 million, $6.6 million and $4.2 million for 1999, 1998 and 1997
respectively.
Included in 1997 revenue was $3.5 million for access to and use by IPL of
the Company's proprietary technology in connection with product development.
The Company, as the holder of all of the issued and outstanding special
shares of IPL, has an option, exercisable at its sole discretion, to
purchase all, but not less than all, of the outstanding common shares of IPL
commencing on the closing date of the offering and ending on the earlier of
(i) September 30, 2002, or (ii) the 90(th) day after the date IPL provides
the Company with quarterly financial statements showing cash or cash
equivalents of less than $3 million. If the purchase option is exercised,
the purchase price calculated on a per share basis would be as follows:
<TABLE>
<CAPTION>
PURCHASE OPTION
EXERCISE PRICE
---------------
<S> <C>
Before October 1, 2000...................................... $39.06
On or after October 1, 2000 and on or before September 30,
2001...................................................... 48.83
On or after October 1, 2001 and on or before September 30,
2002...................................................... 61.04
</TABLE>
The purchase option exercise price may be paid in cash or the Company's
common shares, or any combination of the foregoing, at the Company's sole
discretion.
F-24
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
21. RESEARCH AND DEVELOPMENT ARRANGEMENTS (CONTINUED)
During 1999, under the terms of its Development Contract, Biovail acquired
the rights to Procardia XL for $25 million.
TEVA PHARMACEUTICALS
In December 1997, the Company entered into an agreement with a subsidiary of
Teva for the development and marketing of twelve generic oral controlled
release products. Eight of the twelve products have been identified. As at
December 31, 1999, generic versions of Trental, Cardizem CD, Adalat CC and
Diltiazem SR have been approved by the FDA and ANDAs for four others have
been filed with the FDA.
The Company will incur all costs and expenses for the development and
registration of the eight identified products. The Company and Teva will
jointly select and equally share the costs associated with the development
and registration of the four products in the process of being identified.
Under the terms of the agreement, Teva was obligated to pay the Company an
aggregate of $34.5 million, subject to certain milestones. Of the
$34.5 million, $23.5 million related to reimbursement of research and
development costs and $11.0 million to the initial purchase of product.
Revenue received by the Company from Teva pursuant to the agreement for
reimbursement of research and development costs was $13.5 million and
$10.0 million for 1998 and 1997 respectively. Pursuant to an agreement
signed with Teva, the Company earned research and development revenues of
$4.8 million in 1999.
Product sales to Teva were $19.1 million, $5.0 million and $6.0 million for
1999, 1998 and 1997 respectively.
H. LUNDBECK A/S
In December, 1998, the Company entered into an agreement with H. Lundbeck
A/S ("Lundbeck") based in Denmark, for formulation, development, manufacture
and supply of a novel controlled-release formulation of the anti-depressant
Citalopram.
Under the terms of the agreement, Lundbeck will pay the Company product
development fees aggregating $8.5 million, subject to certain milestones.
Revenue received by the Company from Lundbeck for product development,
pursuant to the agreement, was $2 million in the year ended December 31,
1999 and $3.5 million in 1998.
22. SEGMENTED INFORMATION AND MAJOR CUSTOMERS
Biovail is an international full service pharmaceutical company. The Company
operates in a single industry and is engaged in formulation, clinical
testing, registration and manufacture of drug products utilizing advanced
drug delivery technologies.
Organizationally, the Company's operations consist of three
segments--Product Sales, Research and Development, and Royalty and
Licensing. The segments are determined based on several factors including
customer base, the nature of the product or service provided, delivery
channels and other factors.
The PRODUCT SALES segment covers sales of production from the Company's
Puerto Rico and Canadian facilities and sales by Crystaal, the Canadian
marketing division of the Company.
F-25
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
22. SEGMENTED INFORMATION AND MAJOR CUSTOMERS (CONTINUED)
The RESEARCH AND DEVELOPMENT segment covers all revenues generated by the
Company's integrated research and development facilities, and comprises
research and development services provided to third parties, including IPL,
and product development milestone fees.
The ROYALTY AND LICENSING segment covers royalty revenues received from
licensees in respect of products for which the Company has manufacturing,
marketing and/or intellectual property rights.
The accounting policies of the segments are the same as those described in
the summary of significant accounting policies. The Company evaluates
segment performance based on operating income after deducting selling,
general and administrative expense attributable to the business units.
Corporate general and administrative expense, and interest expense, are not
allocated to segments. Depreciation expense related to manufacturing and
research and development assets is allocated to the Product Sales and
Research and Development segments, respectively. Amortization expense
related to royalty interests is allocated to the Royalty and Licensing
segment. Amortization expense related to product rights is allocated to the
Product Sales segment. Amortization and depreciation of administrative
assets are included as a component of selling, general and administrative
expense.
The following table sets forth information regarding segment operating
income and segment assets:
<TABLE>
<CAPTION>
RESEARCH ROYALTY
PRODUCT AND AND
1999 SALES DEVELOPMENT LICENSING TOTAL
---- -------- ----------- --------- --------
<S> <C> <C> <C> <C>
Revenues from external customers.................... $ 99,526 $ 52,260 $24,706 $176,492
-------- -------- ------- --------
Segment operating income............................ 46,302 16,948 24,292 87,542
Unallocated amounts
Selling, general and administrative expenses...... (8,860)
Equity loss....................................... (1,618)
Interest expense, net............................. (9,152)
Gain on disposal of long-term investments, net.... 1,948
--------
Income before income taxes and goodwill
amortization...................................... $ 69,860
========
Total assets for operating segments................. $139,076 $169,767 $18,888 $327,731
Cash and investments not allocated to segments...... 183,937
Other unallocated assets............................ 123,469
--------
Total consolidated assets........................... $635,137
========
Expenditure on capital and other assets
Attributable to segments.......................... $ 43,137 $ 2,562 $ -- $ 45,699
Other unallocated assets.......................... 425
--------
$ 46,124
========
Amortization of capital and other assets
Attributable to segments.......................... $ 3,130 $ 4,507 $ 1,416 $ 9,053
Unallocated....................................... 1,087
--------
$ 10,140
========
</TABLE>
F-26
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
22. SEGMENTED INFORMATION AND MAJOR CUSTOMERS (CONTINUED)
<TABLE>
<CAPTION>
RESEARCH ROYALTY
PRODUCT AND AND
1998 SALES DEVELOPMENT LICENSING TOTAL
---- -------- ----------- --------- --------
<S> <C> <C> <C> <C>
Revenues from external customers..................... $69,154 $32,070 $11,612 $112,836
------- ------- ------- --------
Segment operating income............................. 30,780 13,047 11,272 55,099
Unallocated amounts
Selling, general and administrative expenses....... (5,796)
Interest income, net............................... (1,702)
--------
Income before income taxes and goodwill
amortization....................................... $ 47,601
========
Total assets for operating segments.................. $86,420 $ 7,845 $18,016 $112,281
Cash and investments not allocated to segments....... 78,503
Other unallocated assets............................. 9,135
--------
Total consolidated assets............................ $199,919
========
Expenditure on capital and other assets
Attributable to segments........................... $ 6,383 $ 740 $15,000 $ 22,123
Other unallocated assets........................... 5,385
--------
$ 27,508
========
Amortization of capital and other assets
Attributable to segments........................... $ 2,209 $ 842 $ 1,482 $ 4,533
Unallocated........................................ 423
--------
$ 4,956
========
</TABLE>
<TABLE>
<CAPTION>
RESEARCH ROYALTY
PRODUCT AND AND
1997 SALES DEVELOPMENT LICENSING TOTAL
---- -------- ----------- --------- --------
<S> <C> <C> <C> <C>
Revenues from external customers...................... $50,333 $19,559 $12,487 $82,379
------- ------- ------- -------
Segment operating income.............................. 24,854 3,589 11,992 40,435
Unallocated amounts
Selling, general and administrative expenses........ (2,744)
Interest expense, net............................... (351)
-------
Income before income taxes and goodwill
amortization........................................ $37,340
=======
Total assets for operating segments................... $69,308 $ 6,448 $ 5,005 $80,761
Cash and investments not allocated to segments........ 6,078
Other unallocated assets.............................. 6,900
-------
Total consolidated assets............................. $93,739
=======
Expenditure on capital and other assets
Attributable to segments............................ $ 1,700 $ 870 $ -- $ 2,570
Other unallocated assets............................ 179
-------
$ 2,749
=======
</TABLE>
F-27
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
22. SEGMENTED INFORMATION AND MAJOR CUSTOMERS (CONTINUED)
<TABLE>
<CAPTION>
RESEARCH ROYALTY
PRODUCT AND AND
1997 SALES DEVELOPMENT LICENSING TOTAL
---- -------- ----------- --------- --------
<S> <C> <C> <C> <C>
Amortization of capital and other assets
Attributable to segments............................ $ 1,756 $ 716 $ 392 $ 2,864
Unallocated......................................... 256
-------
$ 3,120
-------
</TABLE>
GEOGRAPHIC INFORMATION
The following table sets out certain geographic information relative to the
Company:
<TABLE>
<CAPTION>
REVENUE (I) LONG-LIVED ASSETS (II)
------------------------------ ------------------------------
1999 1998 1997 1999 1998 1997
-------- -------- -------- -------- -------- --------
<S> <C> <C> <C> <C> <C> <C>
Canada.............................. $ 16,069 $ 10,735 $11,938 $ 32,523 $23,786 $20,079
United States....................... 116,566 76,498 57,965 201,580 -- --
Caribbean........................... 33,000 9,660 9,639 -- -- --
Puerto Rico and Barbados............ -- -- -- 60,272 27,694 9,889
Other foreign countries............. 10,857 15,943 2,837 327 514 775
-------- -------- ------- -------- ------- -------
$176,492 $112,836 $82,379 $294,702 $51,994 $30,743
======== ======== ======= ======== ======= =======
</TABLE>
----------------------------
(i) Revenues are attributed to countries based on location of customer.
(ii) Consists of capital and other assets, net.
INFORMATION ABOUT MAJOR CUSTOMERS
External customers accounting for 10% or more of the Company's revenues in
1999 are set out as follows:
<TABLE>
<CAPTION>
% OF TOTAL
1999 REVENUE REVENUES INCLUDED IN REPORTABLE SEGMENT
---- -------- ---------- ---------------------------------------------------
<S> <C> <C> <C>
Forest
Laboratories Inc...... $73,569 42 Product Sales (34%), Royalties (7%), Research and
Development (1%)
Teva.................... $23,911 14 Product Sales (11%), Research and Development (3%)
IPL..................... $33,000 19 Research and Development
</TABLE>
External customers accounting for 10% or more of the Company's revenues in
1998 are set out as follows:
<TABLE>
<CAPTION>
% OF TOTAL
1998 REVENUE REVENUES INCLUDED IN REPORTABLE SEGMENT
---- -------- ---------- ---------------------------------------------------
<S> <C> <C> <C>
Forest
Laboratories Inc...... $57,159 51 Product Sales
Teva.................... $18,502 16 Product Sales (4%), Research and Development (12%)
</TABLE>
F-28
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
23. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
The financial statements of the Company have been prepared in accordance
with generally accepted accounting principles in Canada ("Canadian GAAP")
which differ in certain material respects from those applicable in the
United States ("US GAAP").
The material differences as they apply to the Company's financial statements
are as follows:
a) Balance sheet adjustments:
<TABLE>
<CAPTION>
1999 1998
--------- --------
<S> <C> <C>
Deposits and prepaid expenses:
Balance under Canadian GAAP............................... $ 3,172 $ 3,357
Writeoff of product launch advertising costs (i).......... -- (426)
--------- -------
Balance under US GAAP....................................... 3,172 2,931
========= =======
Long-term investments:
Balance under Canadian GAAP............................... 12 10,055
Adjustments for unrealized holding losses (ii)............ -- (877)
--------- -------
Balance under US GAAP....................................... 12 9,178
========= =======
Other assets, net:
Balance under Canadian GAAP............................... 249,402 28,317
Acquired in-process research and development (iii)........ (136,215) --
Acquired product right (iv)............................... (25,000) --
Adjustment to value of goodwill (v)....................... (6,743) --
--------- -------
Balance under US GAAP....................................... 81,444 28,317
========= =======
Shareholders' equity:
Balance under Canadian GAAP............................... 435,294 51,191
Current year net income adjustments....................... (172,458) (3,842)
Cumulative prior year net income adjustments.............. (6,881) (3,039)
Collection of warrant subscription receivable (vi)........ 5,957 1,929
Cumulative employee stock options......................... 12,167 4,526
Adjustment to value of shares issued (v).................. (6,743) --
Unrealized holding losses on long-term investments........ -- (877)
--------- -------
Balance under US GAAP....................................... $ 267,336 $49,888
========= =======
</TABLE>
----------------------------
i) Under US GAAP, companies are required to write-off certain product
launch and advertising costs incurred during the year. This adjustment
represents the portion of product launch costs deferred under Canadian
GAAP that is required to be written off under US GAAP.
ii) Under US GAAP, specifically SFAS No. 115 "Accounting for Certain
Investments in Debt and Equity Securities", the Company classified
certain of its long-term securities as available-for-sale and
accordingly was required to include the change in net unrealized
holding gains or losses on these securities in other comprehensive
income. During the year, these long-term securities were sold and the
net gain is included in net income.
F-29
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
23. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (CONTINUED)
iii) Under US GAAP, specifically SFAS No. 2 "Accounting for Research and
Development Costs", acquired in-process research and development having
no alternative future use must be written-off at the time of
acquisition. The adjustment represents the value of the acquired
in-process research and development, net of accumulated amortization,
capitalized under Canadian GAAP.
iv) Under US GAAP, specifically SFAS No. 2, the cost of intangibles that are
purchased from others for a particular research and development project
that have no alternative future use must be written-off at the time of
acquisition. The adjustment represents the value of the intangible
capitalized under Canadian GAAP.
v) Under US GAAP, the acquisition of Fuisz would be valued based on the
stock market price of the shares before and after the July 25, 1999 date
of the agreement. Under Canadian GAAP, the acquisition was valued based
on the average price at the date of acquisition. The effect is that
under US GAAP the value of shares issued would be lower by $7,763,000
reducing the goodwill acquired by an equal amount. In addition, certain
options were issued to consultants in connection with this acquisition
with a fair value of $1,020,000 that have been included in the
allocation of the purchase price with the effect of increasing goodwill
acquired.
vi) Under US GAAP, companies are required to record in paid-up capital an
amount equal to the proceeds attributable to warrants as determined at
the time of their issuance, along with an offsetting contra equity
account, "Warrant subscription receivable". The contra account is
amortized over the life of the warrants. Under Canadian GAAP, the
offsetting amount was recorded as an immediate reduction in retained
earnings.
b) The components of shareholders' equity under US GAAP are as follows:
<TABLE>
<CAPTION>
1999 1998
--------- --------
<S> <C> <C>
Share Capital............................................... $ 373,962 $23,954
Warrants.................................................... 8,244 8,244
Warrant subscription receivable............................. (2,287) (6,315)
Retained earnings (deficit)................................. (113,843) 26,111
Accumulated other comprehensive income (loss)............... 1,260 (2,106)
--------- -------
$ 267,336 $49,888
========= =======
</TABLE>
F-30
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
23. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (CONTINUED)
c) Reconciliation of net income (loss) under Canadian and US GAAP:
<TABLE>
<CAPTION>
1999 1998 1997
--------- -------- --------
<S> <C> <C> <C>
Net income under Canadian GAAP.............................. $ 62,480 $45,419 $35,241
US GAAP adjustments
Reversal (write-off) of product launch advertising
costs................................................... 426 (426) --
Collection of warrant subscription receivable............. (4,028) (1,179) (750)
Compensation cost for employee stock options (i)............ (7,641) (2,237) (1,669)
Acquired in process research and development................ (136,215) -- --
Acquired product right...................................... (25,000) -- --
--------- ------- -------
(172,458) (3,842) (2,419)
--------- ------- -------
Net income (loss) according to US GAAP...................... $(109,978) $41,577 $32,822
========= ======= =======
Earnings (loss) per share under US GAAP
Basic..................................................... $ (2.15) $ 0.78 $ 0.64
Fully diluted............................................. $ (2.15) $ 0.76 $ 0.62
Weighted average number of common shares outstanding under
US GAAP
Basic..................................................... 51,271 53,282 51,212
Fully diluted............................................. 54,087 54,472 53,238
</TABLE>
----------------------------
(i) Under US GAAP, specifically APB 25 "Accounting for Stock Issued to
Employees", the Company recognizes compensation expense for certain
employee stock option plans. No such expense is required to be
determined under Canadian GAAP.
In accordance with Statement of Financial Accounting Standard ("SFAS") No.
128 "Earnings per Share", basic earnings per share is computed by dividing
income available to common shareholders by the weighted average number of
common shares outstanding for the reporting period. Fully diluted earnings
per share reflect the dilution that would occur if outstanding stock options
and warrants were exercised or converted into common shares using the
treasury stock method. The computation of diluted earnings per share does
not include stock options and warrants with dilutive potential that would
have an antidilutive effect on earnings per share.
Under US GAAP, goodwill amortization would be included in the determination
of operating income. Earnings per share before goodwill amortization would
not be presented.
F-31
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
23. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (CONTINUED)
d) Comprehensive income (loss):
Under US GAAP, the following additional disclosure would be provided
pursuant to the requirements of SFAS No. 130 "Reporting Comprehensive
Income" which established standards for the reporting of comprehensive
income and its components:
<TABLE>
<CAPTION>
STATEMENT OF COMPREHENSIVE INCOME (LOSS) 1999 1998 1997
---------------------------------------- --------- -------- --------
<S> <C> <C> <C>
Net income (loss) under US GAAP............................. $(109,978) $41,577 $32,822
--------- ------- -------
Other comprehensive income (loss), net of tax
Foreign currency translation adjustment................... 2,489 (269) (577)
Unrealized holding loss on long-term investments.......... -- (877) --
Reclassification adjustment for gain on long-term
investments included in net income...................... 877 -- --
--------- ------- -------
Other comprehensive income (loss)........................... 3,366 (1,146) (577)
--------- ------- -------
Comprehensive income (loss) under US GAAP................... $(106,612) $40,431 $32,245
========= ======= =======
</TABLE>
<TABLE>
<CAPTION>
1999 1998
------------------------------------ ------------------------------------
FOREIGN UNREALIZED FOREIGN UNREALISED
ACCUMULATED OTHER COMPREHENSIVE INCOME CURRENCY LOSSES ON CURRENCY LOSSES ON
(LOSS) BALANCES TRANSLATION INVESTMENTS TOTAL TRANSLATION INVESTMENTS TOTAL
-------------------------------------- ----------- ----------- -------- ----------- ----------- --------
<S> <C> <C> <C> <C> <C> <C>
Balance, beginning of year.......... $(1,229) (877) (2,106) (960) -- $ (960)
Current year change................. 2,489 877 3,366 (269) (877) (1,146)
------- ---- ------ ------ ---- -------
Balance, end of year................ $ 1,260 -- 1,260 (1,229) (877) $(2,106)
======= ==== ====== ====== ==== =======
</TABLE>
e) Cash flow adjustments:
<TABLE>
<CAPTION>
1999 1998 1997
--------- -------- --------
<S> <C> <C> <C>
Operating:
Balance under Canadian GAAP............................... $ 81,013 $ 53,573 $ 4,316
Acquired product right.................................. (25,000) -- --
Collection of warrant subscription receivable........... (4,028) (1,179) (750)
--------- -------- -------
Balance under US GAAP..................................... 51,985 52,394 3,566
========= ======== =======
Investing:
Balance under Canadian GAAP............................... (129,393) (32,953) (3,183)
Acquired product right.................................. 25,000 -- --
--------- -------- -------
Balance under US GAAP..................................... (104,393) (32,953) (3,183)
========= ======== =======
Financing:
Balance under Canadian GAAP............................... 147,916 49,493 2,635
Collection of warrant subscription receivable........... 4,028 1,179 750
--------- -------- -------
Balance under US GAAP..................................... $ 151,944 $ 50,672 $ 3,385
========= ======== =======
</TABLE>
F-32
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
23. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (CONTINUED)
f) Under US GAAP, the following additional disclosure would be provided
pursuant to the requirements of SFAS No. 109 "Accounting for Income Taxes":
As at December 31, 1999, the Company has unused tax benefits of
approximately $10,904,000 related to net operating loss and tax credit carry
forwards which relate to the Canadian operations. In addition, the Company
has net operating loss carry forwards relating to the US operations of
approximately $26,950,000. Under US GAAP, a valuation allowance of an
equivalent amount would be recognized to of the related deferred tax asset
due to the uncertainty of realizing the benefit of the loss and tax carry
forwards.
Deferred income taxes have been provided on the following temporary
differences:
<TABLE>
<CAPTION>
1999 1998 1997
-------- -------- --------
<S> <C> <C> <C>
Deferred tax assets
Canadian non-capital losses and tax credits............... $ 16,865 $ 6,293 $ 10,497
US net operating losses carry forward..................... 26,950 -- --
Valuation allowance......................................... (38,781) (6,293) (10,497)
-------- ------- --------
$ 5,034 $ -- $ --
======== ======= ========
Deferred tax liabilities: US technology..................... $ 5,034 $ -- $ --
======== ======= ========
</TABLE>
g) The Company accounts for compensation expense for certain members of its
employee stock option plan under the provisions of Accounting Principals
Board Opinion 25. Had compensation cost for the employee stock option plan
been determined based upon fair value at the grant date for awards under
this plan consistent with the methodology prescribed under SFAS
No. 123--"Accounting for Stock-based Compensation", the Company's net income
and earnings per share would have changed to the pro-forma amounts indicated
below:
<TABLE>
<CAPTION>
1999 1998 1997
--------- -------- --------
<S> <C> <C> <C>
Net income (loss) as reported............................... $(109,978) $41,577 $32,822
Estimated stock-based compensation costs.................... 7,534 5,264 2,053
--------- ------- -------
Pro forma net income (loss)................................. $(117,512) $36,313 $30,769
========= ======= =======
Pro forma earnings (loss) per share......................... $ (2.29) $ 0.68 $ 0.60
========= ======= =======
</TABLE>
The fair values of all options granted during 1999, 1998 and 1997 were
estimated as of the date of grant using the Black-Scholes option pricing
model with the following weighted average assumptions:
<TABLE>
<CAPTION>
1999 1998 1997
-------- -------- --------
<S> <C> <C> <C>
Expected option life (years)................................ 3.81 4.0 4.0
Volatility.................................................. 49.08 47.6 40.2
Risk-free interest rate..................................... 5.73 5.47 5.27
Dividend yield.............................................. nil nil nil
</TABLE>
The Black-Scholes model, used by the Company to calculate option values, as
well as other currently accepted option valuation models, were developed to
estimate the fair value of freely tradeable, fully transferable options
without vesting restrictions, which significantly differ from the Company's
stock option
F-33
<PAGE>
BIOVAIL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
(TABULAR AMOUNTS IN THOUSANDS OF U.S. DOLLARS
EXCEPT NUMBER OF SHARES AND PER SHARE DATA)
23. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (CONTINUED)
awards. These models also require highly subjective assumptions, including
future stock price volatility and expected time until exercise, which
greatly affect the calculated values. Accordingly, management believes that
these models do not necessarily provide a reliable single measure of the
fair value of the Company's stock option awards.
h) There were no impairment write-downs related to goodwill, product
rights, or fixed assets required under US GAAP.
i) Recent Accounting Developments:
i) The Financial Accounting Standards Board has issued Statement No.
133 "Accounting for Derivative Instruments and Hedging Activities",
as amended by Statement No. 137, which is required to be adopted in
years beginning after June 15, 2000. The Company is determining the
impact of the adoption of the new statement.
ii) The Securities and Exchange Commission issued Staff Accounting
Bulletin No. 101, "Revenue Recognition in Financial Statements", in
December 1999, which summarizes certain views in applying generally
accepted accounting principles to revenue recognition in financial
statements. The statements in the staff accounting bulletins
represent interpretations and practices followed by the Division of
Corporation Finance and the Office of the Chief Accountant in
administering the disclosure requirements of the Federal securities
laws. The impact of the application of this Staff Accounting
Bulletin is currently being reviewed by the Company.
24. YEAR 2000 ISSUE
The Year 2000 Issue arises because many computerized systems use two digits
rather than four to identify a year. Date-sensitive systems may recognize
the year 2000 as 1900 or some other date, resulting in errors when
information using year 2000 dates is processed. In addition, similar
problems may arise in some systems which use certain dates in 1999 to
represent something other than a date. Although the change in date to the
year 2000 has occurred, it is not possible to conclude that all aspects of
the Year 2000 Issue that may affect the entity, including those related to
customers, supplier, or other third parties, have been fully resolved.
25. SUBSEQUENT EVENT
On February 7, 2000, the Company announced that it had entered into an
agreement to acquire a pharmaceutical manufacturing facility located in
Dorado, Puerto Rico for $11,000,000. Included in the acquisition of this
facility is the specialized production and packaging equipment. The closing
date is scheduled for January 2001.
F-34
<PAGE>
EXHIBIT 1.1
BY-LAW NO. B
being a by-law to amend By-law No. A of BIOVAIL CORPORATION
(the "Corporation")
BE IT ENACTED as a by-law of the Corporation as follows:
1. 9.10 QUORUM
Subject to paragraph 9.20, a quorum for any meeting of shareholders
shall be, unless a greater number of shares are required to be represented at
the meeting by the Act or by the articles or any other by-law, two persons
present in person, each being a shareholder entitled to vote at the meeting or a
duly appointed proxyholder for an absent shareholder entitled to vote at the
meeting, holding or representing by proxy at least 25% of the total number of
the issued shares of the Corporation for the time being enjoying voting rights
at such meeting. If at any meeting, the requisite quorum is not present within
half an hour after the time appointed for the meeting, then the meeting shall be
adjourned to such date not being less than 10 days later and to such time and
place as may be announced by the chairman at the meeting and subject to 9.18, it
shall not be necessary to give notice of the adjourned meeting.
At such adjourned meeting the persons present at such meeting, provided
that there are at least two such persons present in person, each being a
shareholder entitled to vote at the meeting or a duly appointed proxyholder for
an absent shareholder entitled to vote at the meeting, shall be a quorum for the
transaction of the business for which the meeting was originally called.
2. REPEAL
Paragraph No. 9.10 of By-law No. A be revoked, and any other by-laws
inconsistent herewith be and the same are hereby repealed.
MADE by the board the 11th day of November, 1999.
/S/ EUGENE MELNYK /S/ KENNETH C. CANCELLARA
- ------------------------------------- ---------------------------------
Eugene Melnyk - Chairman of the Board Kenneth C. Cancellara - Secretary
CONFIRMED by the shareholders in accordance with the BUSINESS
CORPORATIONS ACT (Ontario) the 30th day of December, 1999.
/S/ KENNETH C. CANCELLARA
---------------------------------
Kenneth C. Cancellara - Secretary
<PAGE>
EXHIBIT 1.2
Adopted as By-Law No. A of Biovail Corporation International upon
amalgamation dated January 1, 1999, as amended on December 30, 1999
BY-LAW NO. A
A BY-LAW RELATING GENERALLY TO
THE CONDUCT OF THE AFFAIRS OF
BIOVAIL CORPORATION INTERNATIONAL
CONTENTS
1. Interpretation
2. Business of the Corporation
3. Directors
4. Committees
5. Officers
6. Protection of Directors, Officers and Others
7. Shares
8. Dividends and Rights
9. Meetings of Shareholders
10. Information Available to Shareholders
11. Divisions and Departments
12. Notices
13. Effective Date
BE IT ENACTED AND IT IS HEREBY ENACTED as a by-law of Biovail Corporation
International (hereinafter called the "Corporation") as follows:
<PAGE>
SECTION ONE
INTERPRETATION
1.01 DEFINITIONS
In the by-laws of the Corporation, unless the context otherwise
requires:
(1) "ACT" MEANS THE BUSINESS CORPORATIONS ACT, R.S.O. 1990 C. B.16
AND THE REGULATIONS MADE PURSUANT THERETO, AS FROM TIME TO
TIME AMENDED, AND EVERY STATUTE THAT MAY BE SUBSTITUTED
THEREFOR AND, IN THE CASE OF SUCH SUBSTITUTION, ANY REFERENCE
IN THE BY-LAWS OF THE CORPORATION TO PROVISIONS OF THE ACT
SHALL BE READ AS REFERENCES TO THE SUBSTITUTED PROVISIONS
THEREFOR IN THE NEW STATUTE OR STATUTES
(2) "APPOINT" INCLUDES "ELECT" AND VICE VERSA
(3) "BOARD" MEANS THE BOARD OF DIRECTORS OF THE CORPORATION
(4) "BY-LAWS" MEANS THIS BY-LAW AND ALL OTHER BY-LAWS OF THE
CORPORATION FROM TIME TO TIME IN FORCE AND EFFECT
(5) "MEETING OF SHAREHOLDERS" INCLUDES AN ANNUAL MEETING OF
SHAREHOLDERS AND A SPECIAL MEETING OF SHAREHOLDERS; "SPECIAL
MEETING OF SHAREHOLDERS" INCLUDES A MEETING OF ANY CLASS OR
CLASSES OF SHAREHOLDERS AND A SPECIAL MEETING OF ALL
SHAREHOLDERS ENTITLED TO VOTE AT AN ANNUAL MEETING OF
SHAREHOLDERS
(6) "NON-BUSINESS DAY" MEANS SATURDAY, SUNDAY AND ANY OTHER DAY
THAT IS A HOLIDAY AS DEFINED IN THE INTERPRETATION ACT
(ONTARIO)
(7) "RECORDED ADDRESS" MEANS IN THE CASE OF A SHAREHOLDER HIS
ADDRESS AS RECORDED IN THE SECURITIES REGISTER; AND IN THE
CASE OF JOINT SHAREHOLDERS THE ADDRESS APPEARING IN THE
SECURITIES REGISTER IN RESPECT OF SUCH JOINT HOLDING OR THE
FIRST ADDRESS SO APPEARING IF THERE IS MORE THAN ONE; AND IN
THE CASE OF A DIRECTOR, OFFICER, AUDITOR OR MEMBER OF A
COMMITTEE OF THE BOARD HIS LATEST ADDRESS AS RECORDED IN THE
RECORDS OF THE CORPORATION
(8) "SIGNING OFFICER" MEANS, IN RELATION TO ANY INSTRUMENT, ANY
PERSON AUTHORIZED TO SIGN THE SAME ON BEHALF OF THE
CORPORATION BY PARAGRAPH 2.03 OR BY A RESOLUTION PASSED
PURSUANT THERETO
(9) ALL TERMS CONTAINED IN THE BY-LAWS AND WHICH ARE DEFINED IN
THE ACT SHALL HAVE THE MEANINGS GIVEN TO SUCH TERMS IN THE
ACT
(10) THE SINGULAR SHALL INCLUDE THE PLURAL AND THE PLURAL SHALL
INCLUDE THE SINGULAR; THE MASCULINE SHALL INCLUDE THE FEMININE
AND NEUTER GENDERS; AND THE WORD "PERSON" SHALL INCLUDE
INDIVIDUALS, BODIES CORPORATE, CORPORATIONS, COMPANIES,
PARTNERSHIPS, SYNDICATES, TRUSTS, UNINCORPORATED ORGANIZATIONS
AND ANY NUMBER OR AGGREGATE OF PERSONS.
<PAGE>
SECTION TWO
BUSINESS OF THE CORPORATION
2.01 CORPORATE SEAL
The Corporation may have a corporate seal which shall be adopted and
may be changed by resolution of the board.
2.02 FINANCIAL YEAR
The financial year of the Corporation shall be as determined by the
board from time to time.
2.03 EXECUTION OF INSTRUMENTS
Contracts, documents or instruments in writing requiring the signature
of the Corporation may be signed on behalf of the Corporation by any
two of the Chairman, the President or the Secretary of the Corporation
together, provided that (i) any such contracts, documents or
instruments in writing that involve a consideration of $250,000 or more
must be signed by the Chairman and any one other officer of the
Corporation and (ii) any such contracts, etc. that involve a
consideration of less than $100,000 may be signed by any two officers
of the Corporation and contracts, documents and instruments in writing
so signed shall be binding upon the Corporation without any further
authorization or formality. The board shall have power from time to
time by resolution to appoint any officer or officers or any person or
persons on behalf of the Corporation either to sign contracts,
documents and instruments in writing generally or to sign specific
contracts, documents or instruments in writing.
The seal of the Corporation may when required be affixed to contracts,
documents and instruments in writing signed as aforesaid or by any
officer or officers, person or persons, appointed as aforesaid by
resolution of the board.
The term "contracts, documents or instruments in writing" as used in
this by-law shall include deeds, mortgages, hypothecs, charges,
conveyances, transfers and assignments of property, real or personal,
movable or immovable, agreements, releases, receipts and discharges for
the payment of money or other obligations, conveyances, transfers and
assignments of shares, share warrants, stocks, bonds, debentures, notes
or other securities and all paper writings.
The signature or signatures of the Chairman of the Board (if any), the
President, a Vice-President, the Secretary, the Treasurer, an Assistant
Secretary, an Assistant Treasurer or any director of the Corporation
and/or any other officer or officers, person or persons, appointed as
aforesaid by resolution of the board may, if specifically authorized by
resolution of the directors, be printed, engraved, lithographed or
otherwise mechanically reproduced upon any contracts, documents or
instruments in writing or bonds, debentures, notes or other securities
of the Corporation executed or issued by or on behalf of the
Corporation and all contracts, documents or instruments in writing or
bonds, debentures, notes or other securities of the Corporation on
which the signature or signatures of any of the foregoing officers or
directors or persons authorized as aforesaid shall be so reproduced
pursuant to special authorization by resolution of the board, shall be
deemed to have been manually signed by such officers or directors or
persons whose signature or signatures is or are so reproduced and shall
be as valid to all intents and purposes as if they had been signed
manually and notwithstanding that the officers or directors or persons
whose signature or signatures is or are so reproduced may have ceased
to hold office at the date of the delivery or issue of such contracts,
documents or instruments in writing or bonds, debentures, notes or
other securities of the Corporation.
<PAGE>
2.04 BANKING ARRANGEMENTS
The banking business of the Corporation, or any part thereof,
including, without limitation, the borrowing of money and the giving of
security therefor, shall be transacted with such banks, trust companies
or other bodies corporate or organizations as may from time to time be
designated by or under the authority of the board. Such banking
business or any part thereof shall be transacted under such agreements,
instructions and delegations of powers as the board may from time to
time by resolution prescribe or authorize.
2.05 CUSTODY OF SECURITIES
All shares and securities owned by the Corporation shall be lodged (in
the name of the Corporation) with a chartered bank or a trust company
or in a safety deposit box or, if so authorized by resolution of the
board, with such other depositaries or in such other manner as may be
determined from time to time by resolution of the board.
All share certificates, bonds, debentures, notes or other obligations
or securities belonging to the Corporation may be issued or held in the
name of a nominee or nominees of the Corporation (and if issued or held
in the names of more than one nominee shall be held in the names of the
nominees jointly with the right of survivorship) and shall be endorsed
in blank with endorsement guaranteed in order to enable transfer to be
completed and registration to be effected.
2.06 VOTING SHARES AND SECURITIES IN OTHER COMPANIES
All of the shares or other securities carrying voting rights of any
other body corporate held from time to time by the Corporation may be
voted at any and all meetings of shareholders, bondholders, debenture
holders or holders of other securities (as the case may be) of such
other body corporate and in such manner and by such person or persons
as any two of the Chairman together with one other officer shall from
time to time determine. The proper signing officers of the Corporation
may also from time to time execute and deliver for and on behalf of the
Corporation proxies and/or arrange for the issuance of voting
certificates and/or other evidence of the right to vote in such names
as they may determine without the necessity of a resolution or other
action by the board.
SECTION THREE
DIRECTORS
3.01 NUMBER OF DIRECTORS AND QUORUM
The number of directors of the Corporation shall be the number of
directors as specified in the articles or, where a minimum and maximum
number of directors is provided for in the articles, the number of
directors of the Corporation shall be the number of directors
determined from time to time by special resolution or, if a special
resolution empowers the directors to determine the number, the number
of directors determined by resolution of the board. Subject to
paragraph 3.08, the quorum for the transaction of business at any
meeting of the board shall be two-thirds (2/3) of the number of
directors then in office and or in such greater number of directors as
the board may from time to time by resolution determine, provided that
if the Corporation has fewer than three directors, all directors must
be present at any meeting of the board to constitute a quorum.
3.02 QUALIFICATION
No person shall be qualified for election as a director if he is less
than 18 years of age; if he is of unsound mind and has been so found by
a court in Canada or elsewhere; if he is not an individual; or if he
has the status of a bankrupt. A director need not be a shareholder. A
majority of the
<PAGE>
directors shall be resident Canadians, provided that if the
Corporation has only one or two directors, that director or one of
the two directors, as the case may be, shall be a resident Canadian. If
the Corporation is or becomes an offering corporation within the
meaning of the Act, at least one-third of the directors of the
Corporation shall not be officers or employees of the Corporation or
any of its affiliates.
3.03 ELECTION AND TERM
The election of directors shall take place at the first meeting of
shareholders and at each succeeding annual meeting of shareholders and
all the directors then in office shall retire but, if qualified, shall
be eligible for re-election. The number of directors to be elected at
any such meeting shall be the number of directors as specified in the
articles or, if a minimum and maximum number of directors is provided
for in the articles, the number of directors determined by special
resolution or, if the special resolution empowers the directors to
determine the number, the number of directors determined by resolution
of the board. The voting on the election shall be by show of hands
unless a ballot is demanded by any shareholder. If an election of
directors is not held at the proper time, the incumbent directors shall
continue in office until their successors elected.
3.04 REMOVAL OF DIRECTORS
Subject to the provisions of the Act, the shareholders may by ordinary
resolution passed at a meeting specially called for such purpose remove
any director from office and the vacancy created by such removal may be
filled at the same meeting failing which it may be filled by a quorum
of the directors.
3.05 VACATION OF OFFICE
A director ceases to hold office when he dies or, subject to the Act,
resigns; he is removed from office by the shareholders in accordance
with the Act; he becomes of unsound mind and is so found by a court in
Canada or elsewhere or if he acquires the status of a bankrupt.
3.06 VACANCIES
Subject to the Act, a quorum of the board may fill a vacancy in the
board, except a vacancy resulting from an increase in the number or
maximum number of directors or from a failure of the shareholders to
elect the number of directors required to be elected at any meeting of
shareholders. In the absence of a quorum of the board, or if the
vacancy has arisen from a failure of the shareholders to elect the
number of directors required to be elected at any meeting of
shareholders, the directors then in office shall forthwith call a
special meeting of shareholders to fill the vacancy. If the directors
then in office fail to call such meeting or if there are no directors
then in office, any shareholder may call the meeting.
3.07 ACTION BY THE BOARD
The board shall manage or supervise the management of the business and
affairs of the Corporation. Subject to paragraphs 3.08 and 3.09, the
powers of the board may be exercised at a meeting at which a quorum is
present or by resolution in writing signed by all the directors
entitled to vote on that resolution at a meeting of the board. Where
there is a vacancy in the board, the remaining directors may exercise
all the powers of the board so long as a quorum of the board remains in
office.
3.08 CANADIAN MAJORITY
The board shall not transact business at a meeting other than to fill a
vacancy in the board, unless a majority of the directors present are
resident Canadians, except where
<PAGE>
(A) A RESIDENT CANADIAN DIRECTOR WHO IS UNABLE TO BE PRESENT APPROVES
IN WRITING OR BY TELEPHONE OR OTHER COMMUNICATIONS FACILITIES THE
BUSINESS TRANSACTED AT THE MEETING
(B) A MAJORITY OF RESIDENT CANADIANS WOULD HAVE BEEN PRESENT HAD THAT
DIRECTOR BEEN PRESENT AT THE MEETING.
3.09 MEETING BY TELEPHONE
If all the directors of the Corporation present or participating in the
meeting consent, a director may participate in a meeting of the board
or of a committee of the board by means of such telephone, electronic
or other communications facilities as permit all persons participating
in the meeting to communicate with each other simultaneously and
instantaneously, and a director participating in such a meeting by such
means is deemed to be present at the meeting. Any such consent shall be
effective whether given before or after the meeting to which it relates
and may be given with respect to all meetings of the board and of
committees of the board held while a director holds office.
3.10 PLACE OF MEETINGS
Meetings of the board may be held at any place within or outside
Ontario. In any financial year of the Corporation a majority of the
meetings of the board need not be held within Canada.
3.11 CALLING OF MEETINGS
Subject to the Act, meetings of the board shall be held from time to
time on such day and at such time and at such place as the Chairman and
any one other officer of the Corporation may determine and any two of
the Chairman, the President or the Secretary shall convene a meeting of
the board.
3.12 NOTICE OF MEETING
Notice of the date, time and place of each meeting of the board shall
be given in the manner provided in paragraph 12.01 to each director not
less than seven (7) days before the time when the meeting is to be
held. A notice of a meeting of directors need not specify the purpose
of or the business to be transacted at the meeting except where the Act
requires such purpose or business to be specified or except where the
meeting is to deal with the removal from office of any director or
officer or the approval of any matter requiring shareholder approval or
any matter proposed to be put before the shareholders for approval or
consideration.
A director may in any manner waive notice of or otherwise consent to a
meeting of the board.
3.13 FIRST MEETING OF NEW BOARD
Provided a quorum of directors is present, each newly elected board may
without notice hold its first meeting immediately following the meeting
of a shareholders at which such board is elected.
3.14 ADJOURNED MEETING
Notice of an adjourned meeting of the board is not required if the time
and place of the adjourned meeting is announced at the original
meeting.
<PAGE>
3.15 REGULAR MEETINGS
The board may appoint a day or days in any month or months for regular
meetings of the board at a place and hour to be named. A copy of any
resolution of the board fixing the place and time of such regular
meetings shall be sent to each director forthwith after being passed,
but no other notice shall be required for any such regular meeting
except where the Act requires the purpose thereof or the business to be
transacted thereat to be specified.
3.16 CHAIRMAN
The chairman of any meeting of the board shall be the Chairman of the
Board or if the Chairman is not present, such director as the board may
designate.
3.17 VOTES TO GOVERN
At all meetings of the board every question shall be decided by a
majority of the votes cast on the question. In case of an equality of
votes the chairman of the meeting shall be entitled to a second or
casting vote.
3.18 CONFLICT OF INTEREST
A director or officer who is a party to, or who is a director or
officer of or has a material interest in any person who is a party to,
a material contract or transaction or proposed material contract or
transaction with the Corporation shall disclose in writing to the
Corporation or request to have entered in the minutes of the meetings
of the directors the nature and extent of his interest at the time and
in the manner provided by the Act. Any such contract or transaction or
proposed contract or transaction shall be referred to the board or
shareholders for approval even if such contract is one that in the
ordinary course of the Corporation's business would not require
approval by the board or shareholders, and a director interested in a
contract so referred to the board shall not vote on any resolution to
approve the same except as permitted by the Act.
3.19 REMUNERATION AND EXPENSES
The directors shall be paid such remuneration for their services as the
board may from time to time determine. The directors shall also be
entitled to be reimbursed for travelling and other expenses properly
incurred by them in attending meetings of the shareholders or of the
board or any committee thereof or otherwise in the performance of their
duties. Nothing herein contained shall preclude any director from
serving the Corporation in any other capacity and receiving
remuneration therefor.
SECTION FOUR
COMMITTEES
4.01 COMMITTEE OF DIRECTORS
The board may appoint a committee of directors, however designated, and
delegate to such committee any of the powers of the board except those
which pertain to items which, under the Act, a committee of directors
has no authority to exercise. A majority of the members of such
committee shall be resident Canadians.
<PAGE>
4.02 TRANSACTION OF BUSINESS
The powers of a committee of directors may be exercised by a meeting at
which a quorum is present or by resolution in writing signed by all
members of such committee who would have been entitled to vote on that
resolution at a meeting of the committee. Meetings of such committee
may be held at any place within or outside
Ontario.
4.03 AUDIT COMMITTEE
The board may, and shall if the Corporation becomes an offering
corporation within the meaning of the Act, elect annually from among its
number an audit committee to be composed of not fewer than three
directors of whom a majority shall not be officers or employees of the
Corporation or its affiliates. The audit committee shall have the powers
and duties provided in the Act.
4.04 ADVISORY COMMITTEES
The board may from time to time appoint such other committees as it may
deem advisable, but the functions of any such other committees shall be
advisory only.
4.05 PROCEDURE
Unless otherwise determined by the board, each committee shall have
power to fix its quorum at not less than a majority of its members, to
elect its chairman and to regulate its procedure.
SECTION FIVE
OFFICERS
5.01 APPOINTMENT
The board may from time to time appoint a Chairman of the Board, a
President, one or more Vice-Presidents (to which title may be added
words indicating seniority or function), a Secretary, a Treasurer and
such other officers as the board may determine, including one or more
assistants to any of the officers so appointed. The board may specify
the duties of and, in accordance with this by-law and subject to the
provisions of the Act, delegate to such officers powers to manage the
business and affairs of the Corporation. Subject to paragraph 5.02, an
officer may but need not be a director and one person may hold more
than one office. In case and whenever the same person holds the offices
of Secretary and Treasurer, he may but need not be known as the
Secretary-Treasurer. All officers shall sign such contracts, documents,
or instruments in writing as require their respective signatures. In
the case of the absence of inability to act of any officer or for any
other reason that the board may deem sufficient, the board may delegate
all or any of the powers of such officer to any other officer or to any
director for the time being.
5.02 CHAIRMAN OF THE BOARD
The Chairman of the Board shall be a director and shall, when present,
preside at all meetings of the board and committees of the board. The
Chairman of the Board shall be vested with and may exercise such powers
and shall perform such other duties as may from time to time be
assigned to him by the board.
5.03 PRESIDENT
The President shall have general supervision of the business and
affairs of the Corporation and such other powers and duties as the
board may specify from time to time.
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5.04 VICE-PRESIDENT
Each Vice-President shall have such powers and duties as the board or
the President may specify. The Vice-President or, if more than one, the
Vice-President designated from time to time by the board or by the
President, shall be vested with all the powers and shall perform all
the duties of the President in the absence or inability or refusal to
act of the President, provided, however, that a Vice-President who is
not a director shall not preside as chairman at any meeting of the
board and that a Vice-President who is not a director and shareholder
shall not preside as chairman at any meeting of shareholders.
5.05 SECRETARY
The Secretary shall give or cause to be given as and when instructed,
all notices to shareholders, directors, officers, auditors and members
of committees of the board; he shall be the custodian of the stamp or
mechanical device generally used for affixing the corporate seal of the
Corporation and all books, papers, records, documents and instruments
belonging to the Corporation, except when some other officer or agent
has been appointed for that purpose; and he shall have such other
powers and duties as the board may specify.
5.06 TREASURER
The Treasurer shall keep proper accounting records in compliance with
the Act and shall be responsible for the deposit of money, the
safekeeping of securities and the disbursement of the funds of the
Corporation; he shall render to the board whenever required an account
of all his transactions as Treasurer and of the financial position of
the Corporation; and he shall have such other powers and duties as the
board may specify. Unless and until the board designates any other
officer of the Corporation to be the Chief Financial Officer of the
Corporation, the Treasurer shall be the Chief Financial Officer of the
Corporation.
5.07 POWERS AND DUTIES OF OTHER OFFICERS
The powers and duties of all other officers shall be such as the terms
of their engagement call for or as the board may specify. Any of the
powers and duties of an officer to whom an assistant has been appointed
may be exercised and performed by such assistant, unless the board
otherwise directs.
5.08 VARIATION OF POWERS AND DUTIES
The board may from time to time and subject to the provisions of the
Act, vary, add to or limit the powers and duties of any officer.
5.09 TERM OF OFFICE
The board, in its discretion, may remove any officer of the
Corporation, with or without cause, without prejudice to such officer's
rights under any employment contract. Otherwise each officer appointed
by the board shall hold office until his successor is appointed or
until the earlier of his resignation or death.
5.10 TERMS OF EMPLOYMENT AND REMUNERATION
The terms of employment and remuneration of an officer appointed by the
board shall be settled by it from time to time. The fact that any
officer or employee is a director or shareholder of the Corporation
shall not disqualify him from receiving such remuneration as may be so
determined.
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5.11 CONFLICT OF INTEREST
An officer shall disclose his interest in any material contract or
transaction or proposed material contract or transaction with the
Corporation in accordance with paragraph 3.18.
5.12 AGENTS AND ATTORNEYS
The board shall have power from time to time to appoint agents or
attorneys for the Corporation in or outside Canada with such powers or
otherwise (including the powers to subdelegate) as may be thought fit.
5.13 FIDELITY BONDS
The board may require such officers, employees and agents of the
Corporation as the board deems advisable to furnish bonds for the
faithful discharge of their powers and duties, in such form and with
such surety as the board may from time to time determine but no director
shall be liable for failure to require any such bond or for the
insufficiency of any such bond or for any loss by reason of the failure
of the Corporation to receive any indemnity thereby provided.
ARTICLE VI
PROTECTION OF
DIRECTORS, OFFICERS AND OTHERS
6.01 SUBMISSIONS OF CONTRACTS OR TRANSACTIONS TO SHAREHOLDERS FOR APPROVAL
The board in its discretion may submit any contract, act or transaction
for approval, ratification or confirmation at any meeting of the
shareholders called for the purpose of considering the same and any
contract, act or transaction that shall be approved, ratified or
confirmed by a resolution passed by a majority of the votes cast at any
such meeting (unless any different or additional requirement is imposed
by the Act or by the Corporation's articles or any other by-law) shall
be as valid and as binding upon the Corporation and upon all the
shareholders as though it had been approved, ratified or confirmed by
every shareholder of the Corporation.
6.02 FOR THE PROTECTION OF DIRECTORS AND OFFICERS
In supplement of and not by way of limitation upon any rights conferred
upon directors by the provisions of the Act, it is declared that no
director shall be disqualified by his office from, or vacate his office
by reason of, holding any office or place of profit under the
Corporation or under any body corporate in which the Corporation shall
be a shareholder or by reason of being otherwise in any way directly or
indirectly interested or contracting with the Corporation either as
vendor, purchaser or otherwise or being concerned in any contract or
arrangement made or proposed to be entered into with the Corporation in
which he is in any way directly or indirectly interested either as
vendor, purchaser or otherwise nor shall any director be liable to
account to the Corporation or any of its shareholders or creditors for
any profit arising from any such office or place of profit; and,
subject to the provisions of the Act, no contract or arrangement
entered into by or on behalf of the Corporation in which any director
shall be in any way directly or indirectly interested shall be avoided
or voidable and no director shall be liable to account to the
Corporation or any of its shareholders or creditors for any profit
realized by or from any such contract or arrangement by reason of the
fiduciary existing or established thereby. Subject to the provisions of
the Act and to paragraph 3.18, no director shall be obliged to make any
declaration of interest or refrain from voting in respect of a contract
or proposed contract with the Corporation in which such director is in
any way directly or indirectly interested.
<PAGE>
6.03 LIMITATION OF LIABILITY
Except as otherwise provided in the Act, no director or officer for the
time being of the Corporation shall be liable for the acts, receipts,
neglects or defaults of any other director or officer or employee or
for joining in any receipt or act for conformity or for any loss,
damage or expense happening to the Corporation through the
insufficiency or deficiency of title to any property acquired by the
Corporation or for or on behalf of the Corporation or for the
insufficiency or deficiency of any security in or upon which any of the
moneys of or belonging to the Corporation shall be placed out or
invested or for any loss or damage arising from the bankruptcy,
insolvency or tortious act of any persons, firm or corporation
including any person, firm or corporation with whom or which any
moneys, securities or effects shall be lodged or deposited for any
loss, conversion, misapplication or misappropriation of or any damage
resulting from any dealings with any moneys, securities or other assets
belonging to the Corporation or for any other loss, damage or
misfortune whatever which may happen in the execution of the duties of
his respective office or trust or in relation thereto unless the same
shall happen by or through his failure to exercise the powers and to
discharge the duties of his office honestly, in good faith and in the
best interests of the Corporation and in connection therewith to
exercise the degree of care, diligence and skill that a reasonably
prudent person would exercise in comparable circumstances. The
directors for the time being of the Corporation shall not be under any
duty or responsibility in respect of any contract, act or transaction
whether or not made, done or entered into in the name or on behalf of
the Corporation, except such as shall have been submitted to and
authorized or approved by the board. If any director or officer of the
Corporation shall be employed by or shall perform services for the
Corporation otherwise than as a director or officer or shall be a
member of a firm or a shareholder, director or officer of a company
which is employed by or performs services for the Corporation, the fact
of his being a director or officer of the Corporation shall not
disentitle such director or officer or such firm or company, as the
case may be, from receiving proper remuneration for such services.
6.04 INDEMNITY
Subject to the limitations contained in the Act, the Corporation shall
indemnify a director or officer, a former director or officer, or a
person who acts or acted at the Corporation's request as a director or
officer of a body corporate of which the Corporation is or was a
shareholder or creditor, and his heirs and legal representatives,
against all costs, charges and expenses, including an amount paid to
settle an action or satisfy a judgment, reasonably incurred by him in
respect of any civil, criminal or administrative action or proceeding
to which he is made a party by reason of being or having been a
director or officer of the Corporation or such body corporate, if:
(A) HE ACTED HONESTLY AND IN GOOD FAITH WITH A VIEW TO THE BEST
INTEREST OF THE CORPORATION
(B) IN THE CASE OF A CRIMINAL OR ADMINISTRATIVE ACTION OR PROCEEDING
THAT IS ENFORCED BY A MONETARY PENALTY, HE HAD REASONABLE GROUNDS
FOR BELIEVING THAT HIS CONDUCT WAS LAWFUL.
The Corporation shall also indemnify such person in such other
circumstances as the Act permits or requires.
6.05 INSURANCE
The Corporation may purchase and maintain insurance for the benefit of
any person referred to in paragraph 6.04 against such liabilities and
in such amounts as the board may from time to time determine and are
permitted by the Act.
<PAGE>
ARTICLE VII
SHARES
7.01 ALLOTMENT
Upon the approval of two-thirds (2/3) of the total number of directors,
the board may from time to time allot or grant options to purchase
whole or any part of the authorized and unissued shares of the
Corporation at such times and to such persons and for such
consideration as the board shall determine, provided that no share
shall be issued until it is fully paid as provided by the Act.
7.02 COMMISSIONS
The board may from time to time authorize the Corporation to pay a
reasonable commission to any person in consideration of his purchasing
or agreeing to purchase shares of the Corporation, whether from the
Corporation or from any other person, or procuring or agreeing to
procure purchasers for any such shares.
7.03 REGISTRATION OF TRANSFERS
Subject to the provisions of the Act, no transfer of shares shall be
registered in a securities register except upon presentation of the
certificate representing such shares with an endorsement which complies
with the Act made thereon or delivered therewith duly executed by an
appropriate person as provided by the Act, together with such
reasonable assurance that the endorsement is genuine and effective as
the board may from time to time prescribe, upon payment of all
applicable taxes and any fees prescribed by the board, upon compliance
with such restrictions on transfer as are authorized by the articles
and upon satisfaction of any lien referred to in paragraph 7.05.
7.04 TRANSFER AGENTS AND REGISTRARS
The board may from time to time appoint one or more agents to maintain,
in respect of each class of securities of the Corporation issued by it
in registered form, a securities register and one or more branch
securities registers. Such a person may be designated as transfer agent
and registrar according to his functions and one person may be
designated both registrar and transfer agent. The board may at any time
terminate such appointment.
7.05 LIEN FOR INDEBTEDNESS
The Corporation shall have a lien on any share registered in the name
of a shareholder or his legal representatives for a debt of that
shareholder to the Corporation, provided that if the shares of the
Corporation are listed on a stock exchange recognized by the Ontario
Securities Commission, the Corporation shall not have such lien. The
Corporation may enforce any lien that it has on shares registered in
the name of a shareholder indebted to the Corporation by the sale of
the shares thereby affected or by any other action, suit, remedy or
proceeding authorized or permitted by law and, pending such
enforcement, the Corporation may refuse to register a transfer of the
whole or any part of such shares.
7.06 NON-RECOGNITION OF TRUSTS
Subject to the provisions of the Act, the Corporation may treat as
absolute owner of any share the person in whose name the share is
registered in the securities register as if that person had full legal
capacity and authority to exercise all rights of ownership,
irrespective of any indication to the contrary through knowledge or
notice or description in the Corporation's records or on the share
certificate.
<PAGE>
7.07 SHARE CERTIFICATES
Every holder of one or more shares of the Corporation shall be
entitled, at his option, to a share certificate, or to a
non-transferable written acknowledgment of his right to obtain a share
certificate, stating the number and class or series of shares held by
him as shown on the securities register. Share certificates and
acknowledgments of a shareholder's right to a share certificate,
respectively, shall be in such form as the board shall from time to
time approve. Any share certificate shall be signed in accordance with
paragraph 2.03 and need not be under the corporate seal; provided that,
unless the board otherwise determines, certificates representing shares
in respect of which a transfer agent and/or registrar has been
appointed shall not be valid unless countersigned by or on behalf of
such transfer agent and/or registrar. The signature of one of the
signing officers or, in the case of share certificates which are not
valid unless countersigned by or on behalf of a transfer agent and/or
registrar, the signatures of both signing officers, may be printed or
mechanically reproduced in facsimile upon share certificates and every
such facsimile signature shall for all purposes be deemed to be the
signature of the officer whose signature it reproduces and shall be
binding upon the Corporation. A share certificate executed as aforesaid
shall be valid notwithstanding that one or both of the officers whose
facsimile signature appears thereon no longer holds office at the date
of issue of the certificate.
7.08 REPLACEMENT OF SHARE CERTIFICATES
The board or any officer or agent designated by the board may in its or
his discretion direct the issue of a new share certificate in lieu of
and upon cancellation of a share certificate that has been mutilated or
in substitution for a share certificate claimed to have been lost,
destroyed or wrongfully taken on payment of such fee, not exceeding
$3.00, and on such terms as to indemnity, reimbursement of expenses and
evidence of loss and of title as the board may from time to time
prescribe, whether generally or in any particular case.
7.09 JOINT SHAREHOLDERS
If two or more persons are registered as joint holders of any share,
the Corporation shall not be bound to issue more than one certificate
in respect thereof, and delivery of such certificate to one of such
persons shall be sufficient delivery to all of them. Any one of such
persons may give effectual receipts for the certificate issued in
respect thereof or for any dividend, bonus, return of capital or other
money payable or warrant issuable in respect of such shares.
7.10 DECEASED SHAREHOLDERS
In the event of the death of a holder, or of one of the joint holders,
of any share, the Corporation shall not be required to make any entry
in the securities register in respect thereof or to make payment of any
dividends thereon except upon production of all such documents as may
be required by law and upon compliance with the reasonable requirements
of the Corporation and its transfer agents.
SECTION EIGHT
DIVIDENDS AND RIGHTS
8.01 DIVIDENDS
Subject to the provisions of the Act, the board may from time to time
declare dividends payable to the shareholders according to their
respective rights and interest in the Corporation. Dividends may be
paid in money or property or by issuing fully paid shares of the
Corporation.
<PAGE>
8.02 DIVIDEND CHEQUES
A dividend payable in cash shall be paid by cheque drawn on the
Corporation's bankers or one of them to the order of each registered
holder of shares of the class or series in respect of which it has been
declared and mailed by prepaid ordinary mail to such registered holder
at his recorded address, unless such holder otherwise directs. In the
case of joint holders the cheque shall, unless such joint holders
otherwise direct, be made payable to the order of all of such joint
holders and mailed to them at their recorded address. The mailing of
such cheque as aforesaid, unless the same is not paid on due
presentation, shall satisfy and discharge the liability for the
dividend to the extent of the sum represented thereby plus the amount
of any tax which the Corporation is required to and does withhold.
8.03 NON-RECEIPT OF CHEQUES
In the event of non-receipt of any dividend cheque by the person to
whom it is sent as aforesaid, the Corporation shall issue to such
person a replacement cheque for a like amount on such terms as to
indemnity, reimbursement of expenses and evidence of non-receipt and of
title as the board may from time to time prescribe, whether generally
or in any particular case.
8.04 RECORD DATE FOR DIVIDENDS AND RIGHTS
The board may fix in advance a date, preceding by not more than 50 days
the date for the payment of any dividend or the date for the issue of
any warrant or other evidence of the right to subscribe for securities
of the Corporation, as a record date for the determination of the
persons entitled to receive payment of such dividend or to exercise the
right to subscribe for such securities, and notice of any such record
date shall be given not less than seven days before such record date in
the manner provided by the Act. If no record date is so fixed, the
record date for the determination of the persons entitled to receive
payment of any dividend or to exercise the right to subscribe for
securities of the Corporation shall be at the close of business on the
day on which the resolution relating such dividend or right to
subscribe is passed by the board.
8.05 UNCLAIMED DIVIDENDS
Any dividend unclaimed after a period of six years from the date on
which the same has been declared to be payable shall be forfeited and
shall revert to the Corporation.
SECTION NINE
MEETINGS OF SHAREHOLDERS
9.01 ANNUAL MEETINGS
The annual meeting of shareholders shall be held at such time in each
year as the board or the Chairman of the Board together with any one
other officer of the Corporation may from time to time determine, for
the purpose of considering the financial statements and reports
required by the Act to be placed before the annual meeting, electing
directors, appointing an auditor and for the transaction of such other
business as may properly be brought before the meeting.
9.02 SPECIAL MEETINGS
The board or the Chairman of the Board together with any one other
officer of the Corporation shall have power to call a special meeting
of shareholders at any time.
<PAGE>
9.03 PLACE OF MEETINGS
Meetings of shareholders shall be held at the registered office of the
Corporation or elsewhere in the municipality in which the registered
office in situated or, if the board shall so determine, at some other
place in Canada or, if all the shareholders entitled to vote at the
meeting so agree, at some place outside Canada.
9.04 NOTICE OF MEETINGS
Notice of the time and place of each meeting of shareholders shall be
given in the manner provided in paragraph 12.01 not less than 21 days
nor more than 50 days before the date of the meeting to each director,
to the auditor and to each shareholder who at the close of business on
the record date for notice is entered in the securities register as the
holder of one or more shares carrying the right to vote at the meeting.
Notice of a meeting of shareholders called for any purpose other than
consideration of the financial statements and auditor's report,
election of directors and reappointment of the incumbent auditor shall
state or be accompanied by a statement of the nature of such business
in sufficient detail to permit the shareholder to form a reasoned
judgment thereon and the text of any special resolution or by-law to be
submitted to the meeting. A shareholder and any other person entitled
to attend a meeting of shareholders may in any manner waive notice of
or otherwise consent to a meeting of shareholders.
9.05 LIST OF SHAREHOLDERS ENTITLED TO NOTICE
For every meeting of shareholders, the Corporation shall prepare a list
of shareholders entitled to receive notice of the meeting, arranged in
alphabetical order and showing the number of shares held by each
shareholder entitled to vote at the meeting. If a record date for the
meeting is fixed pursuant to paragraph 9.06, the shareholders listed
shall be those registered at the close of business on such record date.
If no record date is fixed, the shareholders listed shall be those
registered at the close of business on the day immediately preceding
the day on which notice of the meeting is given, or where no such
notice is given, the day on which the meeting is held. The list shall
be available for examination by any shareholder during usual business
hours at the registered office of the Corporation or at the place where
the central securities register is maintained and at the meeting for
which the list was prepared.
9.06 RECORD DATE FOR NOTICE
The board may fix in advance a date, preceding the date of any meeting
of shareholders by not more than 50 days and not less than 21 days, as
a record date for the determination of the shareholders entitled to
notice of the meeting, provided that notice of any such record date
shall be given not less than seven days before such record date by
newspaper advertisement in the manner provided in the Act and, if any
shares of the Corporation are listed for trading on a stock exchange in
Canada, by written notice to each such stock exchange. If no record
date is so fixed, the record date for the determination of the
shareholders entitled to notice of the meeting shall be at the close of
business on the day immediately preceding the day on which the notice
is given or, if no notice is given, the day on which the meeting is
held.
9.07 MEETINGS WITHOUT NOTICE
A meeting of shareholders may be held without notice at any time and
place permitted by the Act
(A) IF ALL THE SHAREHOLDERS ENTITLED TO VOTE THEREAT ARE PRESENT IN
PERSON OR REPRESENTED BY PROXY WAIVE NOTICE OF OR OTHERWISE
CONSENT TO SUCH MEETING BEING HELD
(B) IF THE AUDITOR AND THE DIRECTORS ARE PRESENT OR WAIVE NOTICE OF
OR OTHERWISE CONSENT TO SUCH MEETING BEING HELD, SO LONG AS SUCH
SHAREHOLDERS, AUDITOR AND DIRECTORS PRESENT ARE NOT ATTENDING FOR
THE EXPRESS PURPOSE OF OBJECTING TO THE TRANSACTION
<PAGE>
OF ANY BUSINESS ON THE GROUNDS THAT THE MEETING IS NOT LAWFULLY
CALLED. AT SUCH A MEETING ANY BUSINESS MAY BE TRANSACTED WHICH
THE CORPORATION AT A MEETING OF SHAREHOLDERS MAY TRANSACT. IF
THE MEETING IS HELD AT A PLACE OUTSIDE CANADA, SHAREHOLDERS NOT
PRESENT OR REPRESENTED BY PROXY, BUT WHO HAVE WAIVED NOTICE OF OR
OTHERWISE CONSENTED TO SUCH MEETING, SHALL ALSO BE DEEMED TO HAVE
CONSENTED TO THE MEETING BEING HELD AT SUCH PLACE.
9.08 CHAIRMAN, SECRETARY AND SCRUTINEERS
The chairman of any meeting of shareholders shall be the first
mentioned of such of the following officers as have been appointed and
who is present at the meeting: the President or a Vice-President who is
a director and a shareholder. If no such officer is present within 15
minutes from the time fixed for holding the meeting, the persons
present and entitled to vote shall choose one of their number to be
chairman. If the Secretary of the Corporation is absent, the chairman
shall appoint some person, who need not be a shareholder, to act as
secretary of the meeting. If desired, one or more scrutineers, who need
not be shareholders, may be appointed by a resolution or by the
chairman with the consent of the meeting.
9.09 PERSONS ENTITLED TO BE PRESENT
The only persons entitled to be present at a meeting of shareholders
shall be those entitled to vote thereat, the directors and the auditor
of the Corporation and others who, although not entitled to vote are
entitled or required under any provision of the Act or the articles or
the by-laws to be present at the meeting. Any other person may be
admitted only on the invitation of the chairman of the meeting or with
the consent of the meeting.
9.10 QUORUM
Subject to paragraph 9.20, a quorum for any meeting of shareholders
shall be, unless a greater number of shares are required to be
represented at the meeting by the Act or by the articles or any other
by-law, two persons present in person, each being a shareholder
entitled to vote at the meeting or a duly appointed proxyholder for an
absent shareholder entitled to vote at the meeting, holding or
representing by proxy at least 25% of the total number of the issued
shares of the Corporation for the time being enjoying voting rights at
such meeting. If at any meeting, the requisite quorum is not present
within half an hour after the time appointed for the meeting, then the
meeting shall be adjourned to such date not being less than 10 days
later and to such time and place as may be announced by the chairman at
the meeting and subject to 9.18, it shall not be necessary to give
notice of the adjourned meeting.
At such adjourned meeting the persons present at such meeting, provided
that there are at least two such persons present in person, each being
a shareholder entitled to vote at the meeting or a duly appointed
proxyholder for an absent shareholder entitled to vote at the meeting,
shall be a quorum for the transaction of the business for which the
meeting was originally called.
9.11 RIGHT TO VOTE
Subject to the provisions of the Act as to authorized representatives
of any other body corporate or association, at any meeting of
shareholders for which the Corporation has prepared the list referred
to in paragraph 9.05, every person who is named in such list shall be
entitled to vote the shares shown opposite his name except to the
extent that such person has transferred any of his shares after the
record date determined in accordance with paragraph 9.06 and the
transferee, having produced properly endorsed certificates evidencing
such shares or having otherwise established that he owns such shares,
has demanded not later than 10 days before the meeting that his name be
included in such list. In any such case the transferee shall be
entitled to vote the transferred shares at the meeting. At any meeting
of shareholders for which the Corporation has not prepared the list
referred to in paragraph 9.05, every
<PAGE>
person shall be entitled to vote at the meeting who at the
time is entered in the securities register as the holder of one
or more shares carrying the right to vote at such meeting.
9.12 PROXIES
Every shareholder entitled to vote at a meeting of shareholders may
appoint a proxyholder, or one or more alternate proxyholders, who need
not be shareholders, to attend and act at the meeting in the manner and
to the extent authorized and with the authority conferred by the proxy.
A proxy shall be in writing executed by the shareholder or his attorney
authorized in writing and shall conform with the requirements of the
Act.
9.13 TIME FOR DEPOSIT OF PROXIES
The board may by resolution specify in a notice calling a meeting of
shareholders a time, preceding the time of such meeting or an
adjournment thereof by not more than 48 hours exclusive of any part of
a non-business day, before which time proxies to be used at such
meeting must be deposited. A proxy shall be acted upon only if, prior
to the time so specified, it shall have been deposited with the
Corporation or an agent thereof specified in such notice or, if no such
time is specified in such notice, only if it has been received by the
Secretary of the Corporation or by the chairman of the meeting or any
adjournment thereof prior to the time of voting.
9.14 JOINT SHAREHOLDERS
If two or more persons hold shares jointly, any one of them present in
person or represented by proxy at a meeting of shareholders may, in the
absence of the other or others, vote the shares; but if two or more of
those persons are present in person or represented by proxy and vote,
they shall vote as one the shares jointly held by them.
9.15 VOTES TO GOVERN
At any meeting of shareholders every question shall, unless otherwise
required by the articles or by-laws or by law, be determined by a
majority of the votes cast on the question. In case of an equality of
votes either upon a show of hands or upon a poll, the chairman of the
meeting shall be entitled to a second or casting vote.
9.16 SHOW OF HANDS
Subject to the provisions of the Act, any question at a meeting of
shareholders shall be decided by a show of hands unless a ballot
thereon is required or demanded as hereinafter provided. Upon a show of
hands every person who is present and entitled to vote shall have one
vote. Whenever a vote by show of hands shall have been taken upon a
question, unless a ballot thereon is so required or demanded, a
declaration by the chairman of the meeting that the vote upon the
question has been carried or carried by a particular majority or not
carried and an entry to that effect in the minutes of the meeting shall
be prima facie evidence of the fact without proof of the number or
proportion of the votes recorded in favour of or against any resolution
or other proceeding in respect of the said question, and the result of
the vote so taken shall be the decision of the shareholders upon the
said question.
9.17 BALLOTS
On any question proposed for consideration at a meeting of
shareholders, and whether or not a vote by show of hands has been taken
thereon, any shareholder or proxyholder entitled to vote at the meeting
may require or demand a ballot. A ballot so required or demanded shall
be taken in such manner as the chairman shall direct. A requirement or
demand for a ballot may be withdrawn at any time prior to the taking of
the ballot. If a ballot is taken each person present shall be entitled,
in respect of the shares which
<PAGE>
he is entitled to vote at the meeting upon the question, to that
number of votes provided by the Act or the articles, and the result
of the ballot so taken shall be the decision of the shareholders upon
the said question.
9.18 ADJOURNMENT
The chairman at the meeting of shareholders may with the consent of the
meeting and subject to such conditions as the meeting may decide, or
where otherwise permitted under the provisions of the Act, adjourn the
meeting from time to time and from place to place. If a meeting of
shareholders is adjourned for less than 30 days, it shall not be
necessary to give notice of the adjourned meeting, other than by
announcement at the earliest meeting that is adjourned. If a meeting of
shareholders is adjourned by one or more adjournments for an aggregate
of 30 days or more, notice of the adjourned meeting shall be given as
for an original meeting.
9.19 RESOLUTION IN WRITING
A resolution in writing signed by all the shareholders entitled to vote
on that resolution at a meeting of shareholders is as valid as if it
had been passed at a meeting of the shareholders unless a written
statement with respect to the subject matter of the resolution is
submitted by a director or the auditor in accordance with the Act.
9.20 ONLY ONE SHAREHOLDER
Where the Corporation has only one shareholder or only one holder of
any class or series of shares, all business which the Corporation may
transact at an annual or special meeting of shareholders shall be
transacted in the manner provided for in paragraph 9.19.
SECTION TEN
INFORMATION AVAILABLE TO SHAREHOLDERS
10.01 INFORMATION AVAILABLE TO SHAREHOLDERS
Except as provided by the Act, no shareholder shall be entitled to
discovery of any information respecting any details or conduct of the
Corporation's business which in the opinion of the directors it would
be inexpedient to the interests of the Corporation to communicate to
the public.
10.02 DIRECTORS' DETERMINATION
The directors may from time to time, subject to the rights conferred by
the Act, determine whether and to what extent and at what time and
place and under what conditions or regulations the documents, books and
registers and accounting records of the Corporation or any of them
shall be open to the inspection of shareholders and no shareholder
shall have any right to inspect any document or book or register or
accounting record of the Corporation except as conferred by statute or
authorized by the board or by a resolution of the shareholders in
general meeting.
<PAGE>
SECTION ELEVEN
DIVISIONS AND DEPARTMENTS
11.01 CREATION AND CONSOLIDATION OF DIVISIONS
The board may cause the business and operations of the Corporation or
any part thereof to be divided or to be segregated into one or more
divisions upon such basis, including without limitation, character or
type of operation, geographical territory, product manufactured or
service rendered, as the board may consider appropriate in each case.
The board may also cause the business and operations of any such
division to be further divided into sub-units and the business and
operations or any such divisions or sub-units to be consolidated upon
such basis as the board may consider appropriate in each case.
11.02 NAME OF DIVISION
Any division or its sub-units may be designated by such name as the
board may from time to time determine and may transact business under
such name, provided that the Corporation shall set out its name in
legible characters in all contracts, invoices, negotiable instruments
and orders for goods or services issued or made by or on behalf of the
Corporation.
11.03 OFFICERS OF DIVISION
From time to time the board or, if authorized by the board, the Chief
Executive Officer, may appoint one or more officers for any division,
prescribe their powers and duties and settle their terms of employment
and remuneration. The board or, if authorized by the board, the Chief
Executive Officer, may remove at its or his pleasure any officer so
appointed, without prejudice to such officer's rights under any
employment contract. Officers of divisions or their sub-units shall
not, as such, be officers of the Corporation.
SECTION TWELVE
NOTICES
12.01 METHOD OF GIVING NOTICES
Any notice (which term includes any communication or document) to be
given (which term includes sent, delivered or served) pursuant to the
Act, the regulations thereunder, the articles, the by-laws or otherwise
to a shareholder, director, officer, auditor or member of a committee
of the board shall be sufficiently given if delivered personally to the
person to whom it is to be given or if delivered to his recorded
address or if mailed to him at his recorded address by prepaid mail or
if sent to him at his recorded address by any means of prepaid
transmitted or recorded communication. A notice so delivered shall be
deemed to have been given when it is delivered personally or to the
recorded address as aforesaid; a notice so mailed shall be deemed to
have been given when deposited in a post office or public letter box
and shall be deemed to have been received on the fifth day after so
depositing; and a notice so sent by any means of transmitted or
recorded communication shall be deemed to have been given when
dispatched or delivered to the appropriate communication company or
agency or its representative for dispatch. The Secretary may change or
cause to be changed the recorded address of any shareholder, director,
officer, auditor or member of a committee of the board in accordance
with any information believed by him to be reliable.
<PAGE>
12.02 SIGNATURE TO NOTICES
The signature of any director or officer of the Corporation to any
notice or document to be given by the Corporation may be written,
stamped, typewritten or printed or partly written, stamped, typewritten
or printed.
12.03 PROOF OF SERVICE
A certificate of the Chairman of the Board (if any), the President, a
Vice-President, the Secretary of the Treasurer or of any other officer
of the Corporation in office at the time of the making of the
certificate or of a transfer officer of any transfer agent or branch
transfer agent of shares of any class of the Corporation as to the
facts in relation to the mailing or delivery of any notice or other
document to any shareholder, director, officer or auditor or
publication of any notice or other document shall be conclusive
evidence thereof and shall be binding on every shareholder, director,
officer or auditor of the Corporation as the case may be.
12.04 NOTICE TO JOINT SHAREHOLDERS
All notices with respect to shares registered in more than one name
shall, if more than one address appears on the records of the
Corporation in respect of such joint holdings, be given to all of such
joint shareholders at the first address so appearing, and notice so
given shall be sufficient notice to the holders of such shares.
12.05 COMPUTATION OF TIME
In computing the date when notice must be given under any provision
requiring a specified number of days notice of any meeting or other
event both the date of giving the notice and the date of the meeting or
other event shall be excluded.
12.06 UNDELIVERED NOTICES
If any notice given to a shareholder pursuant to paragraph 12.01 is
returned on three consecutive occasions because he cannot be found, the
Corporation shall not be required to give any further notices to such
shareholder until he informs the Corporation in writing of his new
address.
12.07 OMISSIONS AND ERRORS
The accidental omission to give any notice to any shareholder,
director, officer, auditor or member of a committee of the board or the
non-receipt of any notice by any such person or any error in any notice
not affecting the substance thereof shall not invalidate any action
taken at any meeting held pursuant to such notice or otherwise found
thereon.
12.08 DECEASED SHAREHOLDERS
Any notice or other document delivered or sent by post or left at the
address of any shareholder as the same appears in the records of the
Corporation shall, notwithstanding that such shareholder be then
deceased, and whether or not the Corporation has notice of his decease,
be deemed to have been duly served in respect of the shares held by
such shareholder (whether held solely or with any person or persons)
until some other person be entered in his stead in the records of the
Corporation as the holder or one of the holders thereof and such
service shall for all purposes be deemed a sufficient service of such
notice or document on his heirs, executors or administrators and on all
persons, if any, interested with him in such shares.
<PAGE>
12.09 PERSONS ENTITLED BY DEATH OR OPERATION OF LAW
Every person who, by operation of law, transfer, death of a shareholder
or any other means whatsoever, shall become entitled to any share,
shall be bound by every notice in respect of such share which shall
have been duly given to the shareholder from whom he derives his title
to such share prior to his name and address being entered on the
securities register (whether such notice was given before or after the
happening of the event upon which he became so entitled) and prior to
his furnishing to the Corporation the proof of authority or evidence of
his entitlement prescribed by the Act.
12.10 WAIVER OF NOTICE
Any shareholder (or his duly appointed proxyholder), director, officer,
auditor or member of a committee of the board may at any time waive any
notice, or waive or abridge the time for any notice, required to be
given to him under any provision of the Act, the regulations
thereunder, the articles, the by-laws or otherwise and such waiver or
abridgement, whether given before or after the meeting or other event
of which notice is required to be given shall cure any default in the
giving or in the time of such notice, as the case may be. Any such
waiver or abridgement shall be in writing except a waiver of notice of
a meeting of shareholders or of the board or of a committee of the
board which may be given in any manner.
SECTION THIRTEEN
EFFECTIVE DATE
13.01 EFFECTIVE DATE - THIS BY-LAW SHALL COME INTO FORCE WHEN ENACTED BY THE
SHAREHOLDERS, SUBJECT TO THE PROVISIONS OF THE ACT.
SECTION FOURTEEN
REPEAL
14.01 REPEAL - Upon this by-law coming into force, By-law Number 1 of the
Corporation is hereby repealed provided that such repeal shall not
affect the previous operation of such by-laws so repealed or affect the
validity of any act done or right, privilege, obligation or liability
acquired or incurred under the validity of any contract or agreement
made pursuant to any such by-law prior to its repeal.
<PAGE>
EXHIBIT 4.1
CONSENT OF INDEPENDENT AUDITORS
We consent to the incorporation by reference in the Registration
Statement (Form S-8 No. 333-92229) pertaining to the 1993 Stock Option Plan
and the 1996 Employee Stock Purchase Plan of Biovail Corporation of our
report dated February 29, 2000, with respect to the consolidated financial
statements of Biovail Corporation included in the Annual Report (Form 20-F)
for the year ended December 31, 1999.
Toronto, Canada /s/ ERNST & YOUNG LLP
April 19, 2000 Chartered Accountants
<PAGE>
EXHIBIT 4.2
CONSENT OF INDEPENDENT AUDITORS
We consent to the incorporation by reference in Registration Statement No.
333-92229 pertaining to the 1993 Stock Option Plan and the 1996 Employee Stock
Option Plan of Biovail Corporation on Form S-8 of our report dated May 14, 1999
included in this Annual Report on Form 20-F of Biovail Corporation for the year
ended December 31, 1998.
/s/ DELOITTE & TOUCHE LLP
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Chartered Accountants
April 19, 2000
