<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 6-K
REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13A - 16 AND 15D - 16 OF THE
SECURITIES ACT OF 1934
FOR QUARTER ENDED MARCH 31, 1998 COMMISSION FILE NUMBER 001-11145
BIOVAIL CORPORATION INTERNATIONAL
(TRANSLATION OF REGISTRANT'S NAME IN ENGLISH)
2488 DUNWIN DRIVE, MISSISSAUGA, ONTARIO L5L 1J9, CANADA
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES AND ZIP CODE)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (416) 285-6000
INDICATE BY CHECK MARK WHETHER THE REGISTRANT FILES OR WILL
FILE ANNUAL REPORTS UNDER COVER OF FORM 20-F OR FORM 40-F
FORM 20-F X FORM 40-F __
INDICATE BY CHECK MARK WHETHER FOR REGISTRANT BY FURNISHING THE INFORMATION
CONTAINED IN THIS FORM IS ALSO HEREBY FURNISHING THE INFORMATION TO THE
COMMISSION PURSUANT TO RULE 12G 3-2 (B) UNDER THE SECURITIES EXCHANGE ACT OF
1934.
YES __ NO X
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BIOVAIL CORPORATION INTERNATIONAL
QUARTERLY REPORT
INDEX
<TABLE>
<S> <C> <C>
PART 1. FINANCIAL INFORMATION
CONSOLIDATED BALANCE SHEETS, MARCH 31, 1998 AND
DECEMBER 31, 1997................................................1
CONSOLIDATED STATEMENTS OF INCOME
FOR THE THREE MONTHS ENDED MARCH 31, 1998 AND 1997 ..............2
CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE
MONTHS ENDED MARCH 31, 1998 AND 1997 ............................3
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS ..............................4
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS .............................7
PART 11.OTHER INFORMATION ..............................................10
</TABLE>
(ALL DOLLAR AMOUNTS IN THIS DOCUMENT ARE EXPRESSED IN US DOLLARS UNLESS
OTHERWISE STATED.)
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BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
MARCH 31, DECEMBER 31,
1998 1997
----------- ------------
(UNAUDITED)
<S> <C> <C>
ASSETS
Current
Cash and short-term deposits $ 11,248 $ 8,275
Accounts receivable 36,359 33,114
Inventories 18,981 16,609
Executive loans (Note 3) 2,720 2,933
Deposits and prepaids 2,132 2,053
-------- -------
71,440 62,984
Long-term investments (Note 4) 7,500 --
Fixed Assets, net 24,680 24,172
Other Assets, net (Note 5) 21,215 6,583
-------- -------
$124,835 $93,739
======== =======
LIABILITIES
Current
Accounts payable 7,189 4,579
Accrued liabilities 3,724 6,002
Income taxes payable 1,146 1,013
Customer prepayments 6,352 1,840
Current portion of long-term debt 1,791 1,887
-------- -------
20,202 15,321
Long-term Debt (Note 6) 17,483 2,960
-------- -------
37,685 18,281
-------- -------
SHAREHOLDERS' EQUITY
Share capital 22,215 18,465
Warrants 8,244 8,244
Retained earnings 57,557 49,709
Cumulative translation adjustment (866) (960)
-------- -------
87,150 75,458
-------- -------
$124,835 $93,739
======== =======
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
1
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BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED STATEMENTS OF INCOME
(ALL DOLLAR AMOUNTS EXCEPT PER SHARE DATA ARE EXPRESSED IN THOUSANDS OF
U.S. DOLLARS)
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED
MARCH 31,
1998 1997
----------- ------------
<S> <C> <C>
REVENUE
Research and development $ 7,844 $ 740
Manufacturing 11,467 13,290
Royalty and licensing 2,578 2,362
----------- -----------
21,889 16,392
----------- -----------
EXPENSES
Research and development 4,029 3,549
Cost of manufactured goods sold 5,142 4,323
Selling, general and administrative 4,311 2,647
----------- -----------
13,482 10,519
----------- -----------
OPERATING INCOME 8,407 5,873
INTEREST INCOME (EXPENSE), net (68) (15)
----------- -----------
INCOME BEFORE INCOME TAXES 8,339 5,858
PROVISION FOR INCOME TAXES 491 308
----------- -----------
NET INCOME $ 7,848 $ 5,550
=========== ===========
EARNINGS PER SHARE (Note 8) $ 0.29 $ 0.22
=========== ===========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING $26,736,000 $25,430,000
=========== ===========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements.
2
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BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED STATEMENTS OF CASH FLOWS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED
MARCH 31,
1998 1997
--------- ---------
<S> <C> <C>
NET INFLOW (OUTFLOW) OF CASH RELATED
TO THE FOLLOWING ACTIVITIES
OPERATING
Net income for the period $ 7,848 $ 5,550
Depreciation and amortization 1,164 689
-------- --------
9,012 6,239
Change in non-cash operating items (Note 2) (616) (6,045)
-------- --------
8,396 194
-------- --------
INVESTING
Acquisition of royalty interest (Note 5) (15,000) --
Long-term investments (Note 4) (7,500) --
Additions to fixed assets, net (1,207) (780)
Executive loans (Note 3) 213 (30)
-------- --------
(23,494) (810)
-------- --------
FINANCING
Increase in long-term debt (Note 6) 15,000 --
Issuance of share capital 3,660 37
Reduction in long-term debt (597) (939)
-------- --------
18,063 (902)
-------- --------
EFFECT OF EXCHANGE RATE
CHANGES ON CASH 8 (15)
-------- --------
INCREASE (DECREASE) IN CASH 2,973 (1,533)
CASH, BEGINNING OF PERIOD 8,275 4,526
-------- --------
CASH, END OF PERIOD $ 11,248 $ 2,993
======== ========
REPRESENTED BY
Cash and short-term deposits $ 11,248 $ 6,710
Bank indebtedness -- (3,717)
-------- --------
$ 11,248 $ 2,993
======== ========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements
3
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BIOVAIL CORPORATION INTERNATIONAL
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
(UNAUDITED)
1. SIGNIFICANT ACCOUNTING POLICIES
Biovail Corporation International (the "Company"), was amalgamated effective
March 29, 1994, under the laws of the province of Ontario. The Company's
accounting and reporting policies conform to generally accepted accounting
principles in Canada. There were no material differences between generally
accepted accounting principles in Canada and generally accepted accounting
principles in the United States in the reporting periods except for those
described in Note 8.
1997 Figures
Certain of the 1997 figures have been reclassified to conform to the 1998
presentation.
For a full description of the other accounting policies of the Company,
reference is made to the Annual Report on Form 20-F for the year ended
December 31, 1997.
In the opinion of management, all adjustments necessary for a fair
presentation of the financial position, results of operations and cash flows
for the period presented have been made and all such adjustments are of a
normal recurring nature.
2. CHANGE IN NON-CASH OPERATING WORKING CAPITAL
<TABLE>
<CAPTION>
Three Months ended March 31,
(In Thousands)
---------------------------
1998 1997
------- -------
<S> <C> <C>
Accounts receivable............................... $(3,191) $(2,451)
Inventories....................................... (2,332) (1,521)
Deposits and prepaids............................. (78) (231)
Accounts payable and accrued liabilities.......... 339 504
Income taxes payable.............................. 135 183
Customer prepayments.............................. 4,511 (2,529)
------- -------
$ (616) $(6,045)
======= =======
</TABLE>
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3. EXECUTIVE LOANS
Executive loans as at March 31, 1998 consist of Executive Stock Purchase Plan
("ESPP") loans of $2,720,000 made to finance the acquisition of shares of the
Company on the open market by executive officers. The loans are secured by
shares of the Company owned by the executive officers, bear interest at 1/4%
over the prime rate which is equal to the Company's rate for borrowings, and
are due on December 1, 1998.
4. LONG-TERM INVESTMENTS
In March, 1998, the Company made a $7,500,000 investment in a marketable
securities fund. The term of the investment is two years.
5. OTHER ASSETS
In March, 1998, the Company completed the acquisition of the royalty
interest of 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 obligation on the sales of
Tiazac(R) and the Company's generic controlled release version of Cardizem
CD in the United States and Canada.
6. LONG-TERM DEBT
In March, 1998, the Company utilized a $15,000,000 revolving term bank loan
to acquire the royalty interest of Galephar (See Note 5). The loan is
secured by a general security agreement bearing interest at the bank's London
Interbank Offer Rate ("LIBOR"), plus 1 1/2 %. The Company may make
repayments on the loan at any time.
7. LITIGATION
From time to time, the Company becomes involved in various legal matters
which it considers to be in the ordinary course of business. While the
Company is not currently able to determine the potential liability, if
any, related to such matters, the Company believes none of the matters,
individually or in the aggregate, will have a material adverse effect on
its financial position.
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8. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
The financial statements of the Company have been prepared in accordance
with generally accepted accounting principles in Canada ("Cdn GAAP")
which differ in certain respects from those applicable in
the United States ("U.S. GAAP"). The material differences as they apply
to the Company's financial statements are as follows:
a) Reconciliation of net income under Cdn. and U.S. GAAP
<TABLE>
<CAPTION>
THREE MONTHS ENDED MARCH 31,
(IN THOUSANDS EXCEPT PER SHARE DATA)
------------------------------------
1998 1997
---- ----
<S> <C> <C>
Net income under Cdn. GAAP......................... $7,848 $5,550
U.S. GAAP adjustments:
Collection of warrant subscription receivable...... (147) -
------ ------
Net income under U.S. GAAP......................... $7,701 $5,550
====== ======
Earnings per share under U.S. GAAP
Basic.............................................. $0.29 $0 .22
Diluted............................................ $0.27 $0 .21
Weighted average number of common shares
outstanding under U.S. GAAP
Basic.............................................. 26,736 25,430
Diluted............................................ 28,386 26,970
</TABLE>
b) The components of shareholders' equity under U.S. GAAP are as follows:
<TABLE>
<CAPTION>
MARCH 31, 1998 DECEMBER 31, 1997
-------------- -----------------
<S> <C> <C>
Share Capital.......................... $22,215 $18,465
Warrants............................... 8,244 8,244
Warrant subscription receivable, net... (7,347) (7,494)
Retained earnings...................... 64,904 57,203
Cumulative translation adjustment...... (866) (960)
------- -------
$87,150 $75,458
======= =======
</TABLE>
6
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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN U.S. DOLLARS)
OVERVIEW
Biovail Corporation International ("Biovail" or the "Company") derives its
revenues from (i) developing, marketing and licensing oral controlled release
products using its proprietary drug delivery technologies; (ii) manufacturing
such products for sale to licensees and wholesalers; and (iii) providing
pharmaceutical contract research services to third parties.
RESULTS OF OPERATIONS
Revenues for the first quarter of 1998 were $21,889,000 compared with
$16,392,000 in 1997. The increase was primarily due to increased research and
development revenue from third parties and milestone revenue from a subsidiary
of Teva Pharmaceuticals Industries Ltd. ("Teva") related to the Company's
filing of a generic version of Adalat CC with the FDA. Net income increased
41% to $7,848,000, or $0.29 per share, in the first quarter of 1998 compared
with net income of $5,550,000 or $0.22 in 1997.
Research and development revenue from third-party customers was $7,844,000 in
the first quarter of 1998, compared to $740,000 in 1997. The increase in
revenue was due to product development activities on behalf of Teva as stated
above and Intelligent Polymers Limited ("IPL"). Research and development
expenses for the first quarter of 1998 were $4,029,000 as compared to
$3,549,000 in 1997. The increased spending over 1997 reflects the Company's
increased level of research and development activity for third party customers.
Manufacturing revenues for the first quarter of 1998 were $11,467,000 compared
to $13,290,000 in 1997. In 1998 revenues were generated primarily on sales of
Tiazac(R) to Forest Laboratories ("Forest") for the U.S. market, Canadian
market sales of Tiazac(R) by the Company's subsidiary Crystaal Corporation
("Crystaal") and the shipment of prelaunch quantities of product to Teva in
accordance with terms of the agreement. The decrease in manufacturing revenue
from 1997 was due primarily to the expected one time contractual price
reduction to Forest of 25% which occurred at the end of the second quarter of
1997. As a result of the price reduction to Forest, product mix and
manufacturing volumes, the cost of manufactured goods increased to 45% of
revenue in the first quarter of 1998 as compared to 33% in 1997.
Royalty and licensing revenue, net of related expenses, totaled $2,578,000
in the first quarter of 1998, compared to $2,362,000 in 1997. Net royalties
increased 9% in 1998 as compared to 1997 as a result increased Tiazac(R) sales
in the U.S. market and the elimination, net of related amortization expense, of
the Company's royalty obligation on Tiazac(R) sales previously payable to
Galephar Puerto Rico, Inc., Limited ("Galephar").
Selling, general and administrative expenses increased to $4,311,000 in the
first quarter of 1998, compared to $2,647,000 in 1997. The period to period
increase is primarily as a result of
7
<PAGE> 10
increased levels of activity in the Company, including sales and marketing
expenses related to the launch of Tiazac(R) in Canada, the registration
costs associated with Tiazac(R) in the European markets and the hiring of
key management personnel.
Operating income of $8,407,000 was achieved in the first quarter of 1998
compared to operating income of $5,873,000 in 1997. Canadian operations
(including Crystaal, manufacturing and contract research facilities,
research and development and corporate administrative functions) incurred an
aggregate operating loss of $5,296,000 in the first quarter of 1998 compared
to $2,221,000 in 1997. This increase in operating losses is due primarily
to sales and marketing costs associated with the sale of Tiazac(R) in
Canada. Operating income of $773,000 and $1,260,000 in each of the 1998 and
1997 periods respectively was earned by the Company's subsidiary in
Switzerland through royalties earned on Biovail's products (excluding
Tiazac(R)). Operations in Barbados and Puerto Rico contributed operating
income of $12,930,000 in the first quarter of 1998 compared to $6,834,000
in 1997. The increase in operating income in Barbados and Puerto Rico was
due primarily to product development fees and manufacturing sales
activities.
Net interest expense was $68,000 in the first quarter of 1998 compared to
$15,000 in 1997.
Income taxes in the first quarter of 1998 were $491,000 compared to $308,000
in 1997, which tax provisions are reflective of the geographic sources of
income at appropriate rates.
LIQUIDITY AND CAPITAL RESOURCES
As at March 31, 1998, the Company's working capital was $51,238,000 compared
to $47,663,000 at December 31, 1997 which represented a working capital
ratio of 3.5:1 as compared to 4.2:1 respectively.
The Company had positive cash flow of $8,396,000, for the three months
ended March 31, 1998 compared to $194,000 in 1997. Cash generated was as a
result of income from operations (after adding back non-cash charges) of
$9,012,000 and $6,239,000 in the 1998 and 1997 first quarters respectively.
Working capital increased marginally in 1998 due to an increase in accounts
receivable related to the launch of Tiazac(R) in Canada, amounts owing from
Teva relating to the reimbursement of research and development fees and
increases in inventories related to raw material for Tiazac(R) and generic
products.
Although similar increases in the non-cash components of working capital
relative to operating income may occur in the future, the Company believes
such increases are temporary in nature and are not expected to have a
long-term effect on the Company's cash flow.
Investing activities in the first quarter of 1998 relate to the acquisition of
the royalty interest from Galephar for $15,000,000, long-term investments of
$7,500,000 and additions to fixed assets of $1,207,000, offset by a net
repayment of executive loans of $213,000. In the comparable 1997 period
investing activities included additions to fixed assets of $780,000 and loans
fof $30,000 to executive officers.
8
<PAGE> 11
Net cash was generated from financing activities of $18,063,000 in the first
quarter of 1998 compared to net cash used in financing activities of $902,000
in 1997. The 1998 cash generated was as a result of a net increase in long-term
debt of $14,403,000 and $3,660,000 received from the issuance of common shares
on the exercise of stock options. The increase in long-term debt was the
result of the Company's financing the acquisition of the royalty interest from
Galephar. In the comparable period in 1997, cash utilization was as a result
of net long-term debt repayments of $939,000 offset by proceeds of $37,000
received from the issuance of common shares on the exercise of stock options.
Exchange rate changes on foreign cash balances resulted in an increase in cash
of $8,000 in the first quarter of 1998 compared to a reduction of cash of
$15,000 in 1997.
As a result of the foregoing, the Company's cash position as at March 31, 1998
was $11,248,000 compared to $2,993,000 at March 31, 1997.
The Company's total long-term debt (including current portions thereof) was
$19,274,000 as at March 31, 1998 compared to $4,847,000 at December 31, 1997.
In addition, the Company has available lines of credit aggregating $30,000,000
for immediate financing requirements. As of March 31, 1998, there were no
outstanding borrowings against these lines of credit.
The Company believes it has adequate capital and sources of financing to
support its ongoing operational requirements. Furthermore, the Company
believes it will be able to obtain long-term capital, if necessary, to support
its growth objectives. There can be no assurance, however, that the Company's
capital and sources of financing or its ability to obtain additional capital or
sources of financing, at acceptable terms, will be sufficient to sustain the
Company's ongoing operational requirements or its growth objectives.
The Company and its subsidiaries generate revenue and expenses primarily in
U.S. and Canadian dollars. In the first quarter of 1998, revenue was generated
in the following proportions: 85% in U.S. dollars, 14% in Canadian dollars and
1% in other currencies. In addition expenses were incurred in the following
proportions: 75% in U.S. dollars, and 25% in Canadian dollars. The Company does
not believe that its exposure to foreign currency exchange risk is significant
because of the relative stability of the Canadian dollar to the U.S. dollar.
The Company has not historically utilized foreign currency hedging instruments.
INFLATION
Inflation has not had a material impact on the Company's operations.
9
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BIOVAIL CORPORATION INTERNATIONAL
PART II - OTHER INFORMATION
1. OPERATIONAL INFORMATION
The press releases issued by the Company in the 1998 first quarter are
attached as the following exhibits:
a) On January 15, 1998 the Company confirmed that the chairman of the
board filed an amended 13-D reflecting market purchase of shares.
b) On January 22, 1998 the Company confirmed that it has submitted an
ANDA filing for its generic controlled release version of Adalat CC.
c) On February 3, 1998 the Company confirmed that the FDA has approved
the use of Tiazac(R) for the treatment of chronic stable angina.
d) On February 12, 1998 the Company confirmed that it has submitted
an ANDA filing for its generic controlled release version of Procardia
XL.
e) On February 19, 1998 the Company announced that it has entered into
licensing agreements for the sales and marketing of its once daily
diltiazem product Tiazac(R) with Crino International S.p.A. in Italy,
Laboratorios Richmond in Argentina, Barrenne Industria Farmaceutica, in
Brazil and Douglas Pharmaceuticals Ltd. in Australia.
f) On February 25, 1998 the Company reported its 1997 Fourth Quarter
and Year End Financial Results.
g) On March 5, 1998 the Company announced a joint development
agreement with Galephar Puerto Rico, Inc., Limited to develop Novel
Delivery Systems, and the acquisition of product royalty obligations.
h) On March 5, 1998 the Company confirmed that the purchase of the
royalty obligations to Galephar Puerto Rico, Inc., Limited would be
accretive to earnings.
i) On March 12, 1998 the Company announced that its Candian subsidiary
Crystaal Corporation acquired the Canadian marketing rights for
Brexidol from the Chiesi Group.
j) On March 27, 1998 the Company confirmed that the chairman of the
board filed an amended 13-D reflecting market purchase of shares.
10
<PAGE> 13
k) On April 3, 1998 the Company issued comments on a recent Temporary
Restraining Order with respect to the prevention of Mylan Laboratories
from launching a genric version of Dilacor XR prior to the expiration
of a 180 day period from the launch by Andrx Corporation of its own
generic version of the product.
l) On April 6, 1998 the Company issued comments on two court proceedings
dealing with issues concerning the exclusivity provisions of the Food Drug
and Cosmetic Act relating to generic products.
m) On April 6, 1998 the Company commented on two court proceeding;
Granutec vs. Genpharm et. al. and Mova vs. FDA et. al. The Company
also confirmed it has become an Intervenor amicus curiae in Mova vs.
FDA et. al.
n) On April 15, 1998 the Company commented on court ruling issued by
the District of Columbia Court of Appeal on Mova vs. FDA et. al.
o) On April 23, 1998 the Company announced that its Canadian
subsidiary Crystaal Corporation acquired the Canadian marketing rights
for Corlopam from Neurex Corporation.
p) On April 29, 1998 the Company reported its 1997 First Quarter
Financial Results.
q) On May 5, 1998 the Company announced it has signed a licensing
agreement with Glaxo Wellcome S.A. for the sales and marketing of the
Company's controlled release generic version of Trental in Agrentina,
Brazil and Mexico.
2. Legal Proceedings
For detailed information concerning legal proceedings, reference is made
to Note 7 in the financial statement contained as part thereof.
11
<PAGE> 14
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Biovail Corporation International
May 28, 1998 By /s/Kenneth G..Howling
Kenneth G. Howling
Vice President - Finance and
Chief Financial Officer
12
<PAGE> 1
EXHIBIT "A"
FOR: Biovail Corporation International
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
- BIOVAIL CONFIRMS CHAIRMAN SHARE PURCHASES -
TORONTO, Canada, January 15, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today confirmed that Eugene Melnyk, Chairman of the Board, has filed
an amended 13-D reflecting the open market purchase of 122,000 Biovail common
shares with personal funds and the exercise of 810,000 stock options for a
total purchase of 932,000 shares.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "B"
CONTACT: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL CONFIRMS GENERIC ADALAT CC FILING*
TORONTO, Canada, January 22, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today confirmed that it has submitted an Abbreviated New Drug
Application (ANDA) for its generic controlled release version of Adalat CC, a
calcium channel blocker for the treatment of hypertension. This once daily
brand of Nifedipine extended-release is marketed by Bayer Corporation and
represents a $340 million generic opportunity in the U.S.
This submission represents the fifth ANDA filing accepted by the FDA for
Biovail. Eugene Melnyk, Chairman of the Board, commented, "This filing
reaffirms our commitment to growth in the rapidly expanding controlled release
market and we are confident that our product development pipeline will afford
us the opportunity to bring additional products to market in the coming year."
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug
delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "C"
CONTACT: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL'S TIAZAC(R) APPROVED FOR ANGINA*
TORONTO, Canada, February 3, 1998 - Biovail Corporation International
(NYSE, TSE: BVF) today confirmed that the Food and Drug Administration (FDA)
has approved the use of Tiazac(R), Biovail's branded once daily diltiazem
calcium channel blocker, for the treatment of chronic stable angina. Tiazac(R)
was approved by the FDA in September 1995 for the treatment of hypertension and
is marketed in the U.S. by Forest Laboratories, Inc. The once-daily
diltiazem market in the U.S. is in excess of $900 million.
Eugene Melnyk, Chairman of the Board, commented, "We are very pleased that
Tiazac(R) has successfully captured approximately 12% of newly dispensed
prescriptions in the once-daily diltiazem market. With this added indication
we are confident that Tiazac(R) is now well positioned to capture greater
diltiazem market share, particularly in the managed care segment."
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug
delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "D"
CONTACT: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL CONFIRMS GENERIC PROCARDIA XL FILING*
TORONTO, Canada, February 12, 1998 - Biovail Corporation
International (NYSE, TSE:BVF) today announced that the Food and Drug
Administration (FDA) has accepted an Abbreviated New Drug Application
(ANDA) for its generic controlled release version of Procardia XL, a
calcium channel blocker for the treatment of hypertension and angina.
This once daily brand of Nifedipine is marketed by Pfizer Inc. and
represents a generic market opportunity in the U.S. in excess of $800
million.
This represents the second ANDA filing accepted by the FDA for
Biovail in 1998. Biovail currently has six controlled-release generic
products awaiting approval by the FDA representing brand sales in the U.S.
in excess of $2.2 billion.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug
delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act
of 1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and
are subject to risks and uncertainties, including the difficulty of
predicting FDA 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
filings with the Securities and Exchange Commission.
<PAGE> 1
EXHIBIT "E"
CONTACT: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
BIOVAIL NAMES ADDITIONAL TIAZAC(R) INTERNATIONAL LICENSEES
TORONTO, Canada, February 19, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) announced today that it has entered into licensing agreements
covering an additional four countries for the sales and marketing of its once
daily diltiazem product Tiazac(R) which is approved for hypertension. The
agreements include Italy, Argentina, Brazil and Australia. Excluding North
America, Biovail has executed licensing and marketing agreements for Tiazac for
thirteen countries with a combined market opportunity in excess of $390
million.
Eugene Melnyk, Chairman of the Board, commented, "Variations for the approval
of the angina indication have been filed in all European countries where
Tiazac(R) is currently approved. We expect the angina indication approval in
the very near future."
Biovail's additional marketing partners include Crino International S.p.A. for
Italy, Laboratorios Richmond for Argentina, Barrenne Industria
Farmaceutica for Brazil and Douglas Pharmaceuticals Ltd. for Australia.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug
delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "F"
FOR: Biovail Corporation International
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
BIOVAIL REPORTS RECORD 1997 FOURTH QUARTER AND YEAR END FINANCIAL RESULTS
TORONTO, Canada, February 25, 1998 - Biovail Corporation International
(NYSE, TSE:BVF) today reported record fourth quarter and year end
financial results for the period ended December 31, 1997.
Revenue for the fourth quarter of 1997 increased 89% to $26.3 million
compared with $13.9 million reported for the fourth quarter of 1996. Net
income for the fourth quarter of 1997 was $13.2 million, or $0.52 per
share, compared with net income of $6.5 million, or $0.26 per share in the
comparable period of 1996.
Revenues for the year end ended December 31, 1997 increased 24% to
$82.4 million compared with $66.4 million in 1996. Net income increased
52% for the year ended December 31, 1997 to $35.2 million, or $1.38 per
share, compared with net income of $23.2 million, or $0.92 per share, in
1996.
Eugene Melnyk, Chairman of the Board, commented, "The past year was
marked by several major achievements for Biovail that contribute
significantly to the Company's revenue growth and positions Biovail as an
industry leader in the development and commercialization of controlled
release drug products for the global marketplace."
"We have had a very exciting and rewarding year in which record
profits were earned, additional international licensing agreements for
Tiazac(R) were finalized; regulatory approval for the sale of Tiazac(R) in
Canada was received; scientific milestones were achieved with the ANDA
filing of major products with the FDA, including Cardizem CD, Verelan and
recently Adalat CC and Procardia XL; and the licensing of certain of the
Company's ANDA pipeline in Canada. In October we were very successful in
raising approximately $75 million through Intelligent Polymers Limited to
fund NDA product development. This tremendous year was capped off in
December with a major marketing alliance between Biovail and Teva
Pharmaceutical Industries Ltd. for the U.S. distribution of Biovail's
controlled release generic products."
-- More --
<PAGE> 2
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug
delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 3
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
DEC 31, DEC 31,
1997 1996
-------- --------
<S> <C> <C>
ASSETS
Current
Cash and short-term deposits $ 8,275 $ 4,526
Accounts receivable 33,114 10,364
Inventories 16,609 8,134
Executive loans (Note 3) 2,933 2,512
Deposits and prepaids 2,053 1,063
------- -------
62,984 26,599
Fixed Assets, net 24,172 24,819
Other Assets, net 6,583 7,188
------- -------
$93,739 $58,606
======= =======
LIABILITIES
Current
Bank Indebtedness (Note 5) $ -- $ --
Accounts payable 4,579 5,468
Accrued liabilities 6,002 1,738
Income taxes payable 1,013 808
Customer prepayments 1,840 6,681
Current portion of long-term debt 1,887 2,298
------- -------
15,321 16,993
Long-Term Debt 2,960 4,670
18,281 21,663
------- -------
SHAREHOLDERS' EQUITY
Share capital 18,465 14,614
Retained earnings 57,953 22,712
Cumulative translation adjustment (960) (383)
------- -------
75,458 36,943
------- -------
$93,739 $58,606
======= =======
</TABLE>
<PAGE> 4
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED STATEMENTS OF INCOME
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
THREE MONTHS ENDED YEAR ENDED
DECEMBER 31 DECEMBER 31
1997 1996 1997 1996
----------- ----------- ---------- ----------
<S> <C> <C> <C> <C>
REVENUE
Research and development $ 12,513 $ 1,187 $ 19,559 $ 4,374
Manufacturing 11,429 11,157 50,333 54,313
Royalty and licensing 2,363 1,572 12,487 7,743
---------- ---------- ---------- ----------
26,305 13,916 82,379 66,430
---------- ---------- ---------- ----------
EXPENSES
Research and development 2,934 2,403 14,386 10,901
Cost of manufactured goods sold 5,343 3,806 16,471 21,757
Selling, general and administrative 3,914 1,285 13,989 10,166
---------- --------- ---------- ---------
12,191 7,494 44,846 42,824
---------- --------- ---------- ---------
OPERATING INCOME 14,114 6,422 37,533 23,606
INTEREST INCOME (EXPENSE), net (143) (5) (351) 392
INCOME BEFORE INCOME TAXES 13,971 6,417 37,182 23,998
PROVISION FOR INCOME TAXES 767 (117) 1,941 714
---------- --------- ---------- ---------
NET INCOME $ 13,204 $ 6,534 $ 35,241 $ 23,284
========== ========= ========== =========
EARNINGS PER SHARE $0.52 $0.26 $ 1.38 $ 0.92
========== ========= ========== =========
WEIGHTED AVERAGE NUMBER
OF COMMON SHARES
OUTSTANDING 25,606,000 25,378,000 25,606,000 25,378,000
========== ========== ========== ==========
</TABLE>
<PAGE> 1
EXHIBIT "G"
FOR: Biovail Corporation International
CONTACT: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
* BIOVAIL AND GALEPHAR TO DEVELOP NOVEL DELIVERY SYSTEMS *
- ALSO ACQUIRES TIAZAC(R) AND OTHER PRODUCT ROYALTY OBLIGATIONS -
Toronto, Canada, March 5, 1998--- Biovail Corporation International
(NYSE,TSE:BVF) and Galephar Puerto Rico Inc., Limited ("Galephar") today
announced a joint development agreement for the application of Galephar's novel
tableting technology to Biovail's current products which are in advanced stages
of development. This technology will also be applicable to products under
development in Intelligent Polymers Limited.
The agreement provides for payments of up to $2.5 million by Biovail to
Galephar based on certain scientific achievements. In addition, the agreement
releases Biovail from its obligation to pay royalties and other fees to
Galephar for the sale of Tiazac(R) and its generic controlled release version
of Cardizem CD in the United States and Canada in return for a lump sum payment
of $15 million.
Eugene Melnyk, Chairman of the Board of Biovail, commented "We are very
encouraged with the application to date of this novel technology to Biovail's
products, certain of which are anticipated to be filed in the coming year. As
well, the acquisition of Biovail's royalty obligations to Galephar on Tiazac(R)
and generic Cardizem CD sales will be of significant financial benefit going
forward by substantially reducing royalty expenses otherwise payable."
Biovail Corporation International is an international full-service
pharmaceutical company engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "H"
FOR: Biovail Corporation International
CONTACT: Eugene Melnyk
Chairman of the Board
Bob Podruzny
President
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL CONFIRMS $15 MILLION ROYALTY PURCHASE IS ACCRETIVE TO EARNINGS*
Toronto, Canada, March 5, 1998--- Biovail Corporation International
(NYSE,TSE:BVF) today confirmed that the purchase of its royalty obligation to
Galephar Puerto Rico Inc., Limited ("Galephar") will result in a substantial
reduction in royalty expense and will be accretive to earnings by approximately
$0.15 to $0.20 earnings per share.
Biovail has paid $15 million to Galephar in full satisfaction of Biovail's
royalty obligation related to the sales of Tiazac(R) and the Company's generic
controlled release version of Cardizem CD in the United States and Canada.
Biovail Corporation International is an international full-service
pharmaceutical company engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "I"
FOR: Biovail Corporation International
CONTACT: Eugene Melnyk
Chairman of the Board
Kenneth Howling
Chief Financial Officer
Rolf Reininghaus
President, Crystaal Corporation
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL'S SUBSIDIARY, CRYSTAAL, ACQUIRES SIGNIFICANT PRODUCT*
- IN-LICENSES BREXIDOL FROM THE CHIESI GROUP -
Toronto, Canada, March 12, 1998 --- Biovail Corporation International
(NYSE,TSE:BVF) today announced that its Canadian subsidiary, Crystaal
Corporation, has entered into a licensing agreement with Italy's Chiesi Group
for the marketing in Canada of Brexidol. Brexidol is indicated for the relief
of mild to severe acute pain commonly associated with sports injuries and
dysmenorrhea. Utilizing Host-Guest chemistry, once daily Brexidol combines a
rapid onset of action with a long duration of action. Brexidol is the first
medical application of Host-Guest, or supermolecular chemistry, whose
researchers were awarded the Nobel Prize in chemistry in 1987.
Eugene Melnyk, Chairman of the Board, commented, "Brexidol is the second
in-licensing agreement Crystaal has completed and we look forward to concluding
additional product marketing arrangements for the Canadian market during 1998.
Brexidol will compete in the pain and anti-inflammatory market which is valued
at U.S. $150 million annually in Canada and is expected to be approved for
marketing by the Canadian authorities this year."
The Chiesi Group is one of Italy's premier research based pharmaceutical
companies. Its revenues are derived from the sale of pharmaceutical products
primarily in the respiratory, cardio-vascular and muscolo-skeletal therapeutic
areas. Almost 50% of Chiesi Group's sales are generated in more than 30
markets outside Italy.
- more -
<PAGE> 2
Biovail Corporation International is an international full-service
pharmaceutical company engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
<PAGE> 1
EXHIBIT "J"
FOR: Biovail Corporation
International
APPROVED BY: Eugene Melnyk
Chairman of the Board
Kenneth Howling
Chief Financial Officer
(416) 285-6000
FOR IMMEDIATE RELEASE:
- BIOVAIL CONFIRMS CHAIRMAN'S SHARE PURCHASES -
TORONTO, Canada, March 27, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today confirmed that Eugene Melnyk, Chairman of the Board, has filed
an amended 13-D reflecting the open market purchase of 80,000 Biovail common
shares with personal funds at prices between $46.887 and $47.75, as well as the
intent to purchase over the next twelve months, subject to certain conditions
outlined in the 13-D filing, up to an aggregate of an additional 420,000 shares
of common stock in open market transactions.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
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 filings with the Securities and Exchange
Commission.
<PAGE> 1
EXHIBIT "K"
CONTACT: Kenneth C. Cancellara Q.C.
Senior Vice President
General Counsel
Eugene Melnyk
Chairman of the Board
FOR IMMEDIATE RELEASE: (416) 285-6000
*BIOVAIL'S COMMENTS ON RECENT COURT RULING*
TORONTO, Canada, April 3, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today commented on a recent Temporary Restraining Order granted by
Judge Penn with respect to the prevention of Mylan Laboratories from launching
a generic version of Dilacor XR prior to the expiration of a 180 day period
from the launch by Andrx Corporation of its own generic version of the product.
A recent Andrx press release attempted to imply that Judge Penn's
Temporary Restraining Order would somehow influence decisions or could affect
the principles currently under consideration by the Court of Appeal for the
Fourth Circuit (an appeal from Judge Boyle's decision in Granutec vs. Genpharm
et al in which Judge Boyle upheld the FDA's Implementing Regulations) and the
Court of Appeal in the District of Columbia (an appeal from Judge Robertson's
decision in Mova vs. FDA et al).
Legal counsel to the Company has advised Biovail of the following relevant
facts:
1. In November 1997, the FDA, in its Notice in the Federal
Register formally confirmed that it will continue to follow its
Implementing Regulations until the issue of applying exclusivity
periods for generic products has come to a final legal conclusion
(either in the Courts of Appeal or in the U.S. Supreme Court). The
FDA, which was a party to the Andrx action, confirmed its intention
to continue implementing its interpretation of the Regulations at
the Hearing before Judge Penn.
Judge Penn clearly acknowledged that the two Courts of Appeal
decisions with respect to the interpretation of the exclusivity
provisions in the Food Drug & Cosmetic Act were still pending. His
Honour did not, and indeed could not, decide any issue that was under
consideration by those higher level courts. Judge Penn's Temporary
Restraining Order was specifically restricted to the peculiar factual
circumstances in the case before him.
The factual situation that gave rise to the recent Temporary
Restraining Order issued by Judge Penn is clearly distinguishable from
the situations giving rise to the two cases currently pending in the
two Courts of Appeal. In Andrx' recent Motion against Mylan and the
FDA,
<PAGE> 2
Andrx had already enjoyed exclusivity for its Dilacor XR generic
product for some 157 days. It was therefore compelling for Judge Penn
to allow the status quo to prevail for an additional 13 days (until
April 8, 1998). Mylan was unable to demonstrate that, on the balance
of convenience, it was entitled to court protection at this late time.
2. Accordingly, there is no applicability of Judge Penn's
Temporary Restraining Order to the main issues pending in the two
Courts of Appeal. As a further consequence, Judge Penn's decision
neither applies to nor is binding upon the ability by Biovail to
market its generic Cardizem CD upon approval by the FDA.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
<PAGE> 1
EXHIBIT "L"
FOR: Biovail Corporation International
APPROVED BY: Eugene Melnyk
Chairman of the Board
Kenneth C. Cancellara, Q.C
General Counsel
(416) 285-6000
FOR IMMEDIATE RELEASE:
* BIOVAIL COMMENTS ON RECENT COURT PROCEEDINGS *
-RECENT RULING DISSIMILAR FROM COMPANY'S FACTUAL
CIRCUMSTANCES IN CRITICAL ASPECTS-
- COMPANY CONFIRMS IT HAS INTERVENED IN RELEVANT RELATED LITIGATION -
TORONTO, Canada, April 6, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today commented on two court proceedings dealing with issues
concerning the exclusivity provisions of the Food Drug and Cosmetic Act
("FD&C") relating to generic products. The two relevant court proceedings are
Granutec vs. Genpharm et. al. and Mova vs. FDA et. al.
Biovail confirmed that the Fourth Circuit Court of Appeal's decision released
today in Granutec overturned the decision of the District Court which had
upheld FDA's "successful defense" interpretation of the exclusivity provision
of the FD&C Act. The Company confirmed its position that the facts applicable
to the parties in the Granutec case are dissimilar from Biovail's factual
circumstances in a number of critical and key aspects as they relate to
Biovail's version of its generic Cardizem CD. As a result, the Company
commented that the decision does not squarely rule on the applicability of the
exclusivity provisions relating to its filed generic Cardizem CD.
Biovail also confirmed today that on March 20, 1998, in a related Court Case it
became an Intervenor amicus curiae in Mova v. FDA et. al. at the District of
Columbia Court of Appeal level. The Court of Appeal in Mova has accepted for
filing Biovail's submission, as it specifically relates to the filing of its
generic version of Cardizem CD, is considering Biovail's position, and is
expected ultimately to rule on Biovail's specific circumstances in the context
of determining all the issues in that Appeal. The most
<PAGE> 2
crucial and differentiating fact is that, unlike other ANDA submissions,
Biovail was not sued for patent infringement.
Biovail reaffirmed its position that any interpretation that does not take into
account the built-in abuses and unfairness to legitimate ANDA non-infringing
filers when determining the applicability or otherwise of the 180-day
exclusivity set forth in the FD&C Act is inappropriate and will be litigated
vigorously by the Company.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
<PAGE> 1
EXHIBIT "M"
CONTACT: Kenneth C. Cancellara Q.C.
Senior Vice President
General Counsel
Eugene Melnyk
Chairman of the Board
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL APPLAUDS COURT RULING*
OPINIONS IN MOVA DECISION SUPPORT COMPANY POSITION
TORONTO, Canada, April 15, 1998 - Biovail Corporation International
(NYSE,TSE:BVF) commented on yesterday's decision and opinions expressed by the
District of Columbia Court of Appeal on Mova vs. FDA et al dealing with the
exclusivity provisions of the Food, Drug and Cosmetic Act relating to generic
products.
The Court of Appeal opined on Biovail's specific circumstances, the most
crucial of which, unlike other applicants in Mova vs.FDA et al and Granutec
vs. Genpharm et al, is that Biovail was not sued for patent infringement when
it submitted its Paragraph IV Certification related to its generic version of
Cardizem CD. Biovail, who intervened in the Mova litigation and submitted an
amicus curiae brief, confirmed that the Court of Appeals' decision upholding
the lower court decision relates only to those applicants who have been sued
after Certification. In the opinion of the Court, the FDA is encouraged to
address the issue of a meritorious or non-litigated subsequent applicant
through appropriate regulations or otherwise. The Company therefore
anticipates that the FDA review of Biovail's ANDA for a generic version of
Cardizem CD will proceed pursuant to the mandate provided in Sectuion 505 (j)
(B) (5) (iii) of the Food, Drug and Cosmetic Act.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
<PAGE> 1
EXHIBIT "N"
CONTACT: Kenneth C. Cancellara Q.C.
Senior Vice President
General Counsel
Eugene Melnyk
Chairman of the Board
(416) 285-6000
FOR IMMEDIATE RELEASE:
*BIOVAIL APPLAUDS COURT RULING*
OPINIONS IN MOVA DECISION SUPPORT COMPANY POSITION
TORONTO, Canada, April 15, 1998 - Biovail Corporation International
(NYSE,TSE:BVF) commented on yesterday's decision and opinions expressed by the
District of Columbia Court of Appeal on Mova vs. FDA et al dealing with the
exclusivity provisions of the Food, Drug and Cosmetic Act relating to generic
products.
The Court of Appeal opined on Biovail's specific circumstances, the most
crucial of which, unlike other applicants in Mova vs.FDA et al and Granutec
vs. Genpharm et al, is that Biovail was not sued for patent infringement when
it submitted its Paragraph IV Certification related to its generic version of
Cardizem CD. Biovail, who intervened in the Mova litigation and submitted an
amicus curiae brief, confirmed that the Court of Appeals' decision upholding
the lower court decision relates only to those applicants who have been sued
after Certification. In the opinion of the Court, the FDA is encouraged to
address the issue of a meritorious or non-litigated subsequent applicant
through appropriate regulations or otherwise. The Company therefore
anticipates that the FDA review of Biovail's ANDA for a generic version of
Cardizem CD will proceed pursuant to the mandate provided in Sectuion 505 (j)
(B) (5) (iii) of the Food, Drug and Cosmetic Act.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
<PAGE> 1
EXHIBIT "O"
CONTACT: Eugene Melnyk
Chairman of the Board
Kenneth Howling
Chief Financial Officer
Rolf Reininghaus
President
Crystaal Corporation
FOR IMMEDIATE RELEASE: (416) 285-6000
*BIOVAIL'S CRYSTAAL IN-LICENSES CANADIAN RIGHTS TO CORLOPAM FROM NEUREX*
TORONTO, Canada, April 23, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today announced that its wholly owned subsidiary, Crystaal
Corporation ("Crystaal"), has entered into a licensing agreement with Neurex
for the marketing of Corlopam (fenoldopan) in Canada. Corlopam is indicated for
the in-hospital management of hypertension when emergency reduction in blood
pressure is required. Corlopam is the first of a new pharmacological class of
acute care cardiovascular drugs with a novel mechanism of action.
Corlopam has been approved by the FDA and was launched commercially in the
United States in January, 1998. Crystaal anticipates filing a New Drug
Submission with the Therapeutic Products Directorate (T.P.D.) in the second
half of this year, with approval expected in late 1999 or early 2000.
Rolf Reininghaus, President of Crystaal, commented "Corlopam is the first
in a series of acute care products Crystaal is contemplating to in-license.
Corlopam will enhance the visibility of Crystaal in hospitals and with leading
and influential cardiologists in Canada. It will also provide a positive
contribution to earnings. In addition, Corlopam is currently being
investigated for additional indications which could provide opportunities for
the further use of this medication."
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
<PAGE> 1
EXHIBIT "P"
CONTACT: Eugene Melnyk
Chairman of the Board
Ken Howling
Chief Financial Officer
(416) 285-6000
CONTACT: Eugene Melnyk
Chairman of the Board
Ken Howling
Chief Financial Officer
(416) 285-6000
FOR IMMEDIATE RELEASE:
* BIOVAIL REPORTS RECORD 1998 FIRST QUARTER FINANCIAL RESULTS *
TORONTO, Canada, April 29, 1998 - Biovail Corporation
International (NYSE,TSE:BVF) today reported record first quarter
financial results for the period ended March 31, 1998.
Revenue for the first quarter of 1998 increased 34% to $21.9
million, compared with $16.4 million reported for the first quarter of
1997. Net income for the first quarter of 1998 was $7.9 million, or
$0.29 per share, a 41% increase over net income of $5.6 million or
$0.22 per share in the comparable period of 1997.
Eugene Melnyk, Chairman of the Board, commented, "Our first
quarter results demonstrate the Company's focus on continually growing
its business, both scientifically and financially. A number of
important milestones were achieved in the quarter including the ANDA
filings with the FDA of controlled release generic versions of Adalat
CC and Procardia XL; the buyout of royalty obligations related to
future U.S. and Canadian sales of Tiazac(R) and the Company's generic
version of Cardizem CD; and four new licensing agreements for the
distribution of Tiazac(R) in Italy, Argentina, Brazil and Australia.
Crystaal Corporation, Biovail's wholly-owned Canadian subsidiary,
in-licensed two new products for Canada including Brexidol, used in
the treatment of pain commonly associated with sports injuries and
dysmenorrhea, and Corlopam, used for the in-hospital management of
hypertension. Finally, Tiazac(R), currently holding approximately
14 1/2% market share of once-daily diltiazem new prescriptions, was
approved by the FDA for chronic stable angina in the quarter,
positioning the Company to further improve its diltiazem market share,
particularly in the managed care segment.
- more -
<PAGE> 2
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug delivery
technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
- Tables Follow -
<PAGE> 3
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
MARCH 31, DECEMBER 31,
1998 1997
--------- ------------
(UNAUDITED)
<S> <C> <C>
ASSETS
Current
Cash and short-term deposits $ 11,248 $ 8,275
Accounts receivable 36,359 33,114
Inventories 18,981 16,609
Executive loans 2,720 2,933
Deposits and prepaids 2,132 2,053
-------- -------
71,440 62,984
Long-term investments 7,500 --
Fixed Assets, net 24,680 24,172
Other Assets, net 21,215 6,583
-------- -------
$124,835 $93,739
======== =======
LIABILITIES
Current
Accounts payable 7,189 4,579
Accrued liabilities 3,724 6,002
Income taxes payable 1,146 1,013
Customer prepayments 6,352 1,840
Current portion of long-term debt 1,791 1,887
-------- -------
20,202 15,321
Long-term Debt 17,483 2,960
-------- -------
37,685 18,281
======== =======
SHAREHOLDERS' EQUITY
Share capital 22,215 18,465
Warrants 8,244 8,244
Retained earnings 57,557 49,709
Cumulative translation adjustment (866) (960)
-------- -------
87,150 75,458
-------- -------
$124,835 $93,739
======== =======
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements
<PAGE> 4
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED STATEMENTS OF INCOME
(ALL DOLLAR AMOUNTS EXCEPT PER SHARE DATA
ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED
MARCH 31,
1998 1997
---------- -----------
<S> <C> <C>
REVENUE
Research and development $ 7,844 $ 740
Manufacturing 11,467 13,290
Royalty and licensing 2,578 2,362
---------- ----------
21,889 16,392
---------- ----------
EXPENSES
Research and development 4,029 3,549
Cost of manufactured goods sold 5,142 4,323
Selling, general and administrative 4,311 2,647
---------- ----------
13,482 10,519
========== ==========
OPERATING INCOME 8,407 5,873
INTEREST INCOME (EXPENSE), net (68) (15)
---------- ----------
INCOME BEFORE INCOME TAXES 8,339 5,858
PROVISION FOR INCOME TAXES 491 308
---------- ----------
NET INCOME $ 7,848 $ 5,550
========== ==========
EARNINGS PER SHARE $ 0.29 $ 0.22
========== ==========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 26,736,000 25,430,000
========== ==========
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements
<PAGE> 1
EXHIBIT "Q"
CONTACT: Eugene Melnyk
Chairman of the Board
Kenneth Howling
Chief Financial Officer
(416) 285-6000
FOR IMMEDIATE RELEASE:
* BIOVAIL SIGNS LATIN AMERICAN MARKETING AGREEMENT WITH
GLAXO WELLCOME *
TORONTO, Canada, May 5, 1998 - Biovail Corporation International (NYSE,
TSE: BVF) today announced that it has signed a licensing agreement with Glaxo
Wellcome S.A. for the marketing of Biovail's controlled release generic version
of Trental(R), (Pentoxifylline) in Argentina, Brazil and Mexico. Trental(R) is
prescribed for the treatment of chronic peripheral arterial disease and
generates annual sales in excess of $52 million in Latin America. Glaxo
Wellcome has an option to market the product in seven additional Latin American
markets.
Eugene Melnyk, Chairman of the Board, commented, "Biovail continues to
exploit its capability of successfully licensing its products in International
markets. Latin America is currently one of the fastest growing pharmaceutical
markets and Glaxo Wellcome's presence in Latin America is strong. The market
dynamics are favorable and launch of the product is anticipated in the first
half of 1999."
Glaxo Wellcome is a research based company whose people are committed to
fighting disease by bringing innovative medicines and services to patients
throughout the world and the healthcare providers that serve them.
Biovail Corporation International is an international full-service
pharmaceutical company, engaged in the formulation, clinical testing,
registration and manufacture of drug products utilizing advanced drug
delivery technologies.
"Safe Harbor" statement under the Private Securities Litigation Reform Act of
1995.
To the extent any statements made in this release contain information that
is not historical, these statements are essentially forward looking and are
subject to risks and uncertainties, including the difficulty of predicting FDA
and TPD 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 filings with the Securities and
Exchange Commission.
