<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13A - 16 AND 15D - 16 OF
THE SECURITIES EXCHANGE ACT OF 1934
FOR QUARTER ENDED MARCH 31, 1997 COMMISSION FILE NUMBER 001-11145
BIOVAIL CORPORATION INTERNATIONAL
(TRANSLATION OF REGISTRANT'S NAME INTO 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 THEREBY FURNISHING THE INFORMATION TO THE
COMMISSION PURSUANT TO RULE 12G 3-2 (B) UNDER THE SECURITIES EXCHANGE ACT OF
1934.
YES ___ NO X
___
<PAGE> 2
BIOVAIL CORPORATION INTERNATIONAL
QUARTERLY REPORT
INDEX
<TABLE>
<S> <C>
PART 1. FINANCIAL INFORMATION
CONSOLIDATED BALANCE SHEETS, MARCH 31, 1997 AND
DECEMBER 31, 1996.......................................... 1
CONSOLIDATED STATEMENTS OF INCOME
FOR THE THREE MONTHS ENDED MARCH 31, 1997 AND 1996......... 2
CONSOLIDATED STATEMENTS OF CASH FLOW
FOR THE THREE MONTHS ENDED MARCH 31, 1997 AND 1996......... 3
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS...................... 4
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS.................................. 6
PART II. OTHER INFORMATION.............................. 8
</TABLE>
(ALL DOLLAR AMOUNTS IN THIS DOCUMENT ARE EXPRESSED IN U.S. DOLLARS UNLESS
OTHERWISE STATED.)
2
<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,
1997 1996
----------- -----------
(UNAUDITED)
<S> <C> <C>
ASSETS
Current
Cash and short-term deposits $ 6,710 $ 4,526
Accounts receivable 12,839 10,364
Inventories 9,670 8,134
Executive stock purchase plan loans (Note 3) 2,541 2,512
Deposits and prepaids 1,294 1,063
------- -------
33,054 26,599
Fixed Assets 24,838 24,819
Other Assets 7,051 7,188
------- -------
$64,943 $58,606
======= =======
LIABILITIES
Current
Bank Indebtedness (Note 5) $ 3,717 $ -
Accounts payable 5,824 5,468
Accrued liabilities 1,882 1,738
Income taxes payable 989 808
Customer prepayments 4,151 6,681
Current portion of long-term debt 1,950 2,298
------- -------
18,513 16,993
Long-Term Debt 4,010 4,670
------- -------
22,523 21,663
------- -------
SHAREHOLDERS' EQUITY
Share capital 14,505 14,614
Retained earnings 28,262 22,712
Cumulative translation adjustment (347) (383)
------- -------
42,420 36,943
------- -------
$64,943 $58,606
======= =======
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements
1
<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, MARCH 31,
--------- ---------
1997 1996
--------- ---------
<S> <C> <C>
REVENUE
Contract $ 740 $ 1,157
Manufacturing 13,290 12,771
Royalty and licensing 2,362 2,346
----------- ----------
16,392 16,274
----------- ----------
EXPENSES
Cost of contract revenue 484 929
Cost of manufactured goods sold 4,323 5,464
Research and product development 3,065 2,039
Selling, general and administrative 2,647 2,943
----------- ----------
10,519 11,375
----------- ----------
OPERATING INCOME 5,873 4,899
INTEREST INCOME (EXPENSE), net (15) 170
----------- ----------
INCOME BEFORE INCOME TAXES 5,858 5,069
PROVISION FOR INCOME TAXES 308 382
----------- ----------
NET INCOME $ 5,550 $ 4,687
=========== ===========
EARNINGS PER SHARE - (Note 6) $ 0.22 $ 0.18
=========== ===========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 25,430,000 25,343,000
=========== ===========
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements
2
<PAGE> 5
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,
1997 1996
------- -------
<S> <C> <C>
NET INFLOW (OUTFLOW) OF CASH RELATED
TO THE FOLLOWING ACTIVITIES
OPERATING
Net income for the period $ 5,550 $ 4,687
Depreciation and amortization 689 464
------- -------
6,239 5,151
Change in non-cash operating items (Note 2) (6,075) 978
------- -------
164 6,129
------- -------
INVESTING
Additions to fixed assets, net (780) (1,632)
------- -------
(780) (1,632)
------- -------
FINANCING
Reduction in long-term debt (939) (369)
Increase in long-term debt - 249
Issuance of share capital 37 25
------- -------
(902) (95)
------- -------
EFFECT OF EXCHANGE RATE CHANGES ON CASH (15) (294)
------- -------
(DECREASE) INCREASE IN CASH (1,533) 4,108
CASH, BEGINNING OF PERIOD 4,526 24,323
------- -------
CASH, END OF PERIOD $ 2,993 $28,431
======= =======
REPRESENTED BY
Cash and short-term deposits $ 6,710 $28,431
Bank indebtedness (Note 5) (3,717) -
------- -------
$ 2,993 $28,431
======= =======
</TABLE>
The accompanying notes are an integral part of the
consolidated financial statements
3
<PAGE> 6
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.
Royalty revenue is recognized on an accrual basis in accordance
with the contractual agreements with third parties and is net of
amounts payable to sublicensees.
Certain of the 1996 figures have been reclassified to conform to
the 1997 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, 1996.
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)
----------------------------
1997 1996
------ ------
<S> <C> <C>
Accounts receivable $(2,451) $ (481)
Inventories (1,521) (1,427)
Executive Stock Purchase Plan Loans (30) -
Deposits and prepaid expenses (231) (282)
Accounts payable and accrued liabilities 504 2,566
Income taxes payable 183 (93)
Deferred revenue (2,529) 695
------- -------
$(6,075) $ 978
======= =======
</TABLE>
4
<PAGE> 7
3. EXECUTIVE STOCK PURCHASE PLAN LOANS
Executive stock purchase plan loans as at March 31, 1997 comprise loans of
$2,451,000 made to finance the acquisition of shares of the Company on the open
market by executive officers. These loans are secured by the shares, bear
interest at 1/4% over the bank prime rate, equal to the Company's rate for
borrowings, and are due on December 31, 1997.
4. 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.
5. BANK INDEBTEDNESS
The Company has an operating line of credit of $10,950,000 with a Canadian
chartered bank for which a specified charge on accounts receivable and
inventories has been given. As at March 31, 1997, the Company utilized
$3,717,000 in borrowings under this line of credit.
6. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
The items included in the table below give rise to differences in net
income under generally accepted accounting principles in the United States
("U.S. GAAP").
<TABLE>
<CAPTION>
THREE MONTHS ENDED MARCH 31,
(IN THOUSANDS EXCEPT PER SHARE DATA)
------------------------------------
RECONCILIATION OF NET INCOME UNDER CANADIAN AND U.S. GAAP 1997 1996
------ ------
<S> <C> <C>
Net income according to U.S. and Canadian GAAP $ 5,550 $ 4,687
======= =======
Earnings per share under U.S. GAAP $ 0.21 $ 0.18
======= =======
Weighted average number of common shares outstanding under
US. GAAP (1) 26,821 26,626
======= =======
</TABLE>
1) The weighted average number of common shares outstanding for purposes of
the computation of the earnings per share under U.S. GAAP gives effect to
the exercise of outstanding options and the 3 for 1 stock split in January,
1996.
There are no differences between shareholders' equity determined under Canadian
and U.S. GAAP at either March 31, 1997, or December 31, 1996.
5
<PAGE> 8
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN U.S. DOLLARS)
OVERVIEW
The Company derives its revenues from (1) the development and licensing of oral
controlled release products using its proprietary drug delivery technology; (2)
the manufacture of such drugs for sale to licensees; (3) royalties from sales
by licensees of Company developed products; and (4) providing contract research
services.
RESULTS OF OPERATIONS
Revenues for the first quarter of 1997 were $16,392,000 compared with
$16,274,000 in 1996. Net income increased 18% to $5,550,000, or $0.22 per
share, in the first quarter of 1997 compared with net income of $4,687,000 or
$0.18 per share, in 1996. The increase in profit in 1997 is primarily
attributable to improved margins on Tiazac(R) due to the higher proportion of
trade vs. sample sales in 1997 compared to 1996.
Revenue realized by the Contract Research Division from external customers was
$740,000 in the first quarter of 1997 compared to $1,157,000 in 1996. Revenues
were down in the quarter primarily as a result of the scheduling of significant
internal Company projects, which is evidenced by the increase in research and
development expenditures in the quarter. Operating margins were 34.6% in the
first quarter of 1997, compared to 19.7% in 1996.
Manufacturing revenues of $13,290,000 were generated on sales of Tiazac(R) in
the first quarter of 1997, compared to $12,771,000 in 1996. In the first
quarter of 1997, trade volumes approximated 95%, whereas in 1996, trade
volumes were 40% compared to 60% for samples. As a result of the lower cost
of manufacture for trade supplies and continuously improving manufacturing
efficiencies, the manufacturing margin improved to 67.5%, up from 57.2% in
1996.
Royalty revenue, net of royalty expenses, totaled $2,362,000 in the first
quarter of 1997, compared to $2,346,000 last year.
Research and product development expenditures were $3,065,000 in the first
quarter of 1997 up from $2,039,000 expended in 1996 and reflects the
significant level of activity in the Company on the development of new
products.
Selling, general and administrative costs were $2,647,000 in the quarter, down
from $2,943,000 in 1996, primarily as a result of lower legal and marketing
costs. As in prior quarters, all costs related to the Canadian sales and
marketing organization have been expensed as incurred.
Operating income of $5,873,000 was achieved in the first quarter of 1997,
compared to operating income of $4,899,000 in 1996. Canadian operations
incurred losses of $2,221,000 and $2,737,000 in 1997 and 1996 respectively.
Operating income of $1,260,000 and $906,000 in each of the 1997 and 1996
periods respectively was earned by the Company's subsidiary in
6
<PAGE> 9
Switzerland through royalties earned on the Company's products. Barbados
contributed operating income of $6,834,000 in the first quarter of 1997
compared to $6,728,000 in 1996.
Net interest expense was $15,000 in the first quarter of 1997 compared to
interest income of $170,000 in 1996.
Income taxes in the first quarter of 1997 were $308,000 compared to $382,000 in
1996, which tax provisions are reflective of the geographic sources of income
at appropriate tax rates.
LIQUIDITY AND CAPITAL RESOURCES
As at March 31, 1997, the Company's working capital was $14,541,000 compared to
$9,606,000 at December 31, 1996 and represented working capital ratios of 1.8:1
and 1.6:1 respectively.
The Company generated $164,000 in cash-flow from operating activities for the
three months ended March 31, 1997 compared to $6,129,000 in 1996. Cash
generated was as a result of income from operations (after adding back non-cash
charges) of $6,239,000 and $5,151,000 in the 1997 and 1996 first quarters
respectively, and an increase in non-cash operating items of $6,075,000 and a
reduction of $978,000 in the two respective quarters.
Investing activities used cash of $780,000 in the first quarter of 1997,
compared to $1,632,000 in 1996. In both quarters, cash utilization was for
additions to fixed assets.
Financing activities used net cash of $902,000 in the first quarter of 1997
compared to a usage of $95,000 in 1996. Cash utilization for the first quarter
of 1997 was for long-term debt repayments of $939,000, offset in part by the
issuance of share capital of $37,000. The 1996 cash utilization was for
long-term debt repayments of $349,000, offset in part by the issuance of common
shares for $25,000 and increases in long-term debt of $249,000.
Exchange rate changes on foreign cash balances resulted in a reduction of
cash of $15,000 in the first quarter of 1997, compared to a reduction of
$294,000 in 1996.
As a result of the foregoing, the Company's net cash balance was $2,993,000 as
at March 31, 1997, compared to $4,256,000 at December 31, 1996 and $28,431,000
at March 31, 1996.
The Company's total long-term debt was $5,960,000 as at March 31, 1997
compared to $6,968,000 at December 31, 1996 and $10,085,000 at March 31, 1996.
In addition, the Company has available a line of credit of $10,950,000 for
short-term financing of which $3,717,000 was utilized as at March 31, 1997.
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.
INFLATION
Inflation has not had a material impact on the Company's operations.
7
<PAGE> 10
BIOVAIL CORPORATION INTERNATIONAL
PART II - OTHER INFORMATION
1. OPERATIONAL INFORMATION
The press releases issued by the Company in the 1997 first quarter are
attached as the following exhibits:
a) On February 27, 1997, the Company reported its 1996 Fourth Quarter and
Year End Financial Results.
b) On March 12, 1997, the Company confirmed the Chairman of the Board
purchase of 125,000 shares on the open market.
c) On April 15, 1997, the Company announced it has received approval from
the Health Protection Branch to market Tiazac(R) in Canada, to be
marketed by a newly created wholly-owned subsidiary CRYSTAAL
Corporation.
d) On April 28, 1997, the Company reported its 1997 First Quarter
Financial results, confirmed the ANDA filing for Generic Cardizem CD
in the U.S.; and the signing of European Licensing Agreements for
Tiazac(R).
e) On April 30, 1997, the Company confirmed the ANDA filing for Generic
Verelan in the U.S.
2. LEGAL PROCEEDINGS
For detailed information concerning legal proceedings, reference is made to
Note 4 in the financial statement contained as part hereof.
8
<PAGE> 1
[BIOVAIL LETTERHEAD] EXHIBIT "A"
FOR: BIOVAIL CORPORATION INTERNATIONAL
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
Chief Financial Officer
(416) 285-6000
CONTACT: Investor Relations: Donna Stein/
Dan Durkin/Cindy Hintelmann
Press: Michael McMullan
Morgen-Walke Associates
(212) 850-5600
FOR IMMEDIATE RELEASE
BIOVAIL CORP. REPORTS RECORD 1996 FOURTH QUARTER AND YEAR END
FINANCIAL RESULTS
TORONTO, Canada, February 27, 1997 -- Biovail Corporation International
(NYSE, TSE:BVF) today reported record fourth quarter and year end financial
results for the period ended December 31, 1996.
Revenues for the fourth quarter of 1996 increased 53% to $13.9 million,
compared with $9.1 million reported for the fourth quarter of 1995. Operating
income increased to $6.4 million in the fourth quarter of 1996, compared to
operating income of $2.8 million in 1995. Net income for the fourth quarter of
1996 was $6.5 million, or $0.26 per share, compared with net income of $2.9
million, or $0.12 per share in the comparable period of 1995.
Revenues for the year end ended December 31, 1996 increased 239% to $66.4
million compared with $19.6 million in 1995. Operating income for the year
ended December 31, 1996 of $23.6 million, compared with operating income of $2.6
million in 1995. Net income for the year ended December 31, 1996 was $23.3
million, or $0.92 per share, compared with net income of $5.9 million, or $0.23
per share, in 1995. Weighted average number of common shares outstanding for
1996 were 25,378,000 compared with 24,993,000 in 1995.
-- More --
[BIOVAIL LETTERFOOT]
<PAGE> 2
Eugene Melnyk, Chairman of the Board, commented, "The past year was marked
by several major achievements for Biovail that will contribute significantly to
the Company's revenue growth and positioning as an industry leader in the
development of advanced controlled release drug systems and products for the
global pharmaceutical marketplace. One of the most exciting accomplishments
during the past year was the U.S. launch of Tiazac(R), by our U.S. partner
Forest Laboratories. Tiazac(R) is Biovail's once-daily formulation of the
calcium channel blocker diltiazem, a medication approved for the treatment of
hypertension and recently submitted for approval in angina. We have also
secured a number of international licensing agreements for Tiazac, including
The DuPont Merck Pharmaceutical Company for the United Kingdom and Ireland,
Laboratorios Alter for Spain and Pierre Fabre S.A. in France. We continue to
aggressively pursue other licensing agreements in Europe and anticipate
securing further territories in the near term."
"During the quarter, we entered into a Settlement Agreement with Elan Corp
Plc., which resolves all claims and counterclaims with respect to patent
infringement as it relates to Elan's diltiazem patents. With the threat of
patent infringement behind us, Biovail will accelerate its program of bringing
generic versions of existing controlled release products to market, including
the filing of ANDA's for Cardizem(R) CD and Verelan(R)," said Mr. Melnyk.
"We achieved many significant milestones during the quarter including,
Biovail shares beginning to trade on the New York Stock Exchange in December.
This listing gives us the opportunity to achieve greater visibility and
liquidity for our Company, as well as offering our current and potential
shareholders the best trading environment for our common stock. We also
submitted an ANDA for our controlled release generic version of Trental(R)
(pentoxifylline), a medication used for the treatment of peripheral vascular
disease. This submission represented the second ANDA filing for Biovail in 1996.
The Company's twice-daily generic of Cardizem SR, used in the treatment of
hypertension was previously filed in the second quarter."
"In 1997, we will continue to build on the success and momentum
established in 1996. We remain confident that Tiazac(R) will continue to win
widespread acceptance within the anti-hypertensive market place, and also look
forward to achieving new milestones with respect to our product pipeline in the
coming quarters," concluded Mr. Melnyk.
<PAGE> 3
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> 4
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED STATEMENTS OF INCOME
(ALL DOLLAR AMOUNTS EXCEPT PER SHARE DATA
ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
THREE MONTHS ENDED YEAR ENDED
DECEMBER 31, DECEMBER 31,
------------------------- -------------------------
1996 1995 1996 1995
---------- ---------- ---------- ----------
<S> <C> <C> <C> <C>
REVENUE
Contract $ 1,187 $ 574 $ 4,374 $ 4,333
Manufacturing 11,157 6,685 54,313 7,915
Royalty and licensing 1,572 1,856 7,743 7,396
----------- ----------- ----------- -----------
13,916 9,115 66,430 19,644
----------- ----------- ----------- -----------
EXPENSES
Cost of contract revenue 788 461 3,417 2,732
Cost of manufactured goods sold 3,806 2,238 21,757 2,715
Research and product development 1,615 1,665 7,484 4,462
Selling, general and administrative 1,285 1,911 10,166 7,182
----------- ----------- ----------- -----------
7,494 6,275 42,824 17,091
----------- ----------- ----------- -----------
OPERATING INCOME 6,422 2,840 23,606 2,553
INTEREST INCOME (EXPENSE), net (5) 214 392 (99)
GAIN ON LICENSING SETTLEMENT -- -- -- 3,617
----------- ----------- ------------ -----------
INCOME BEFORE INCOME TAXES 6,417 3,054 23,998 6,071
PROVISION FOR INCOME TAXES (117) 164 714 201
----------- ----------- ----------- -----------
NET INCOME $ 6,534 $ 2,890 $ 23,284 $ 5,870
=========== =========== =========== ===========
EARNINGS PER SHARE $ 0.26 $ 0.12 $ 0.92 $ 0.23
=========== =========== =========== ===========
WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING 25,378,000 24,993,000 25,378,000 24,993,000
=========== =========== =========== ===========
</TABLE>
<PAGE> 5
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 1996 AND 1995
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
1996 1995
-------- --------
<S> <C> <C>
ASSETS
CURRENT
Cash and short-term deposits $ 4,526 $24,323
Accounts receivable 10,364 6,379
Inventories 8,134 3,868
Due from officers 2,512 --
Deposits and prepaid expense 1,063 176
------- -------
26,599 34,746
FIXED ASSETS, NET 24,819 19,910
OTHER ASSETS, NET 7,188 6,211
------- -------
$58,606 $60,867
======= =======
LIABILITIES
CURRENT
Accounts payable $ 5,468 $ 5,628
Accrued liabilities 1,738 3,043
Income taxes payable 808 968
Customer prepayments 6,681 22,167
Current portion of long-term debt 2,298 2,244
------- -------
16,993 34,050
CUSTOMER PREPAYMENTS -- 4,274
LONG-TERM DEBT 4,670 7,951
------- -------
21,663 46,275
------- -------
SHAREHOLDERS' EQUITY
Share capital 14,614 14,489
Retained earnings (deficit) 22,712 (572)
Cumulative translation account (383) 675
------- -------
36,943 14,592
------- -------
$58,606 $60,867
======= =======
</TABLE>
<PAGE> 1
[BIOVAIL LETTERHEAD] EXHIBIT "B"
FOR: BIOVAIL CORPORATION INTERNATIONAL
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
Chief Financial Officer
(416) 285-6000
CONTACT: Investor Relations: Donna Stein/
Dan Durkin/Cindy Hintelmann
Press: Michael McMullan
Morgen-Walke Associates
(212) 850-5600
FOR IMMEDIATE RELEASE
BIOVAIL CORP. CHAIRMAN INCREASES STAKE
TORONTO, Canada, March 12, 1997 -- Biovail Corporation International (NYSE,
TSE:BVF) confirmed today that Eugene Melnyk, Chairman of the Board, has filed an
amended 13-D to reflect the purchase of 125,000 shares of Biovail common stock
with personal funds 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 product 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 filing with the Securities and Exchange
Commission.
# # #
[BIOVAIL LETTERFOOT]
<PAGE> 1
[BIOVAIL LETTERHEAD] EXHIBIT "C"
FOR: BIOVAIL CORPORATION INTERNATIONAL
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
Chief Financial Officer
(416) 285-6000
CONTACT: Investor Relations: Donna Stein/
Dan Durkin/Cindy Hintelmann
Press: Stacy Berns
Morgen-Walke Associates
(212) 850-5600
FOR IMMEDIATE RELEASE
BIOVAIL LAUNCHES TIAZAC(R) IN CANADA
-CRYSTAAL CORPORATION, BIOVAIL'S NEWLY CREATED
WHOLLY-OWNED SUBSIDIARY, TO MARKET-
TORONTO, Canada, April 15, 1997 -- Biovail Corporation International (NYSE,
TSE:BVF) today announced it has received approval from the Health Protection
Branch and has commenced marketing of Tiazac in Canada. Tiazac, Biovail's
once-daily diltiazem product, is being marketed by a newly created wholly-owned
subsidiary, Crystaal Corporation, and is available in dosage strengths of 120mg,
180mg, 240mg, 300mg and 360mg.
Crystaal Corporation will market Tiazac directly to physicians, enabling
Biovail to benefit from the extremely dynamic Canadian market. Crystaal will
also be marketing Biovail's existing controlled release product portfolio, as
well as select in-licensed products from third parties which were previously
unavailable in Canada. The Company expects Crystaal Corporation, with its unique
identity and portfolio, to become a significant force in the Canadian healthcare
market.
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 filing with the Securities and Exchange
Commission.
# # #
[BIOVAIL LETTERFOOT]
<PAGE> 1
[BIOVAIL LETTERHEAD] EXHIBIT "D"
FOR: BIOVAIL CORPORATION INTERNATIONAL
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
Chief Financial Officer
(416) 285-6000
CONTACT: Investor Relations: Donna Stein/
Dan Durkin/Cindy Hintelmann
Press: Stacy Berns
Morgen-Walke Associates
(212) 850-5600
FOR IMMEDIATE RELEASE
BIOVAIL REPORTS FIRST QUARTER 1997 FINANCIAL RESULTS
--CONFIRMS ANDA FILING FOR GENERIC CARDIZEM CD IN THE U.S.;
SIGNS NEW EUROPEAN LICENSING AGREEMENTS FOR TIAZAC(R)--
TORONTO, Canada, April 28, 1997 -- Biovail Corporation International (NYSE,
TSE:BVF) today reported first quarter financial results for the period ended
March 31, 1997. The Company also confirmed it has submitted an Abbreviated New
Drug Application (ANDA) for Cardizem CD to the U.S. Food and Drug Administration
(FDA) and has signed additional licensing agreements with European partners for
Tiazac(R), Biovail's once-daily formulation of the calcium channel blocker,
diltiazem.
Revenues for the first quarter of 1997 were $16.4 million, compared with
$16.3 million reported for the first quarter of 1996. Net income increased 18%
to $5.6 million, or $0.22 per share, in the first quarter of 1997 compared with
net income of $4.7 million, or $0.18 per share, in 1996. The prime contributor
for the increase in profit was improved margins on Tiazac(R) sales due to the
higher proportion of trade vs. sample sales in 1997 compared to 1996. Eugene
Melnyk, Chairman, commented, "We are very pleased with our first quarter results
which meet or exceed analyst expectations. Continued Tiazac(R) penetration in
the U.S. diltiazem market contributed significantly and we anticipate further
growth in penetration in coming quarters."
[BIOVAIL LETTERFOOT]
<PAGE> 2
Biovail also confirmed that it has submitted an ANDA for a generic version
of Cardizem CD to the FDA. This product represents a $700 million market in the
U.S. and is marketed by Hoechst Marion Roussel. Mr. Melnyk commented, "This
recent ANDA submission is an important milestone for the Company, as we continue
to demonstrate our ability to develop important pharmaceutical products with
significant market potential. In addition, we successfully completed studies
required for an ANDA filing of a generic version of Verelan, which we expect to
submit to the FDA very shortly. With two previously filed ANDAs pending at the
FDA, we are very excited about our prospects to bring additional products to
market in the coming year." Biovail also has eight other products in advanced
stages of development in its product pipeline.
In addition, the Company has signed new marketing partnerships for
Tiazac(R) in Germany and The Netherlands. In Germany, Biovail signed licensing
agreements with Ratiopharm GmbH, a subsidiary of Merckle GmbH, and Heumann GmbH,
a division of Searle, USA. Ratiopharm is a leading German generic pharmaceutical
company and Heumann is a premiere marketer of pharmaceutical products, with more
than 250 sales representatives covering Germany. In The Netherlands, Biovail has
signed an agreement with Zambon B.V., a multinational manufacturer and marketer
of pharmaceutical, chemical and hospital home care products.
The Company reported that new prescription data indicates that Tiazac(R)'s
market share has increased to 9.3% of new, once-daily diltiazem prescriptions
written in the U.S. "Tiazac(R) continues to perform well and is meeting all
expectations," said Mr. Melnyk. "In Europe, we have begun shipping product to
Dupont Merck, our licensing partner in the United Kingdom and Ireland, and will
start to record revenues in the second quarter of 1997. The new licensing
agreements announced today are important additions to the strong network we are
creating to address the European Community, which collectively represents a $400
million diltiazem market. With licensing agreements now signed for the UK,
Ireland, France, Spain, Germany and The Netherlands, we will continue to
aggressively pursue agreements in other European countries."
Mr. Melnyk concluded. "Our recent approval for Tiazac(R) in five dosage
strengths (120mg, 180mg, 240mg, 300mg and 360mg) by the Health Protection Branch
in Canada marks the beginning of a very focused marketing and sales campaign
aimed directly at physicians by our newly-created, wholly-owned subsidiary,
Crystaal Corporation, known previously as Biovail Pharma. Crystaal will generate
initial revenues in the second quarter of 1997. In addition, Crystaal will also
market Biovail's existing controlled release product portfolio, as well as
select in-licensed branded products, throughout Canada. For example, Crystaal
has reached an agreement with Forest Laboratories Inc. to in-license
Flumadine(R), an anti-viral drug used for the treatment of influenza A."
<PAGE> 3
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> 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,
--------------------
1997 1996
---- ----
<S> <C> <C>
REVENUE
Contract $ 740 $ 1,157
Manufacturing 13,290 12,771
Royalty and licensing 2,362 2,346
----------- -----------
16,392 16,274
----------- -----------
EXPENSES
Cost of contract revenue 484 929
Cost of manufactured goods sold 4,323 5,464
Research and product development 3,065 2,039
Selling, general and administrative 2,647 2,943
----------- -----------
10,519 11,375
----------- -----------
OPERATING INCOME 5,873 4,899
INTEREST INCOME (EXPENSE), net (15) 170
----------- -----------
INCOME BEFORE INCOME TAXES 5,858 5,069
PROVISION FOR INCOME TAXES 308 382
----------- -----------
NET INCOME $ 5,550 $ 4,687
=========== ===========
EARNINGS PER SHARE $ 0.22 $ 0.18
=========== ===========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 25,430,000 25,343,000
=========== ===========
</TABLE>
<PAGE> 5
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
MARCH 31, DECEMBER 31,
1997 1996
------------ ------------
(UNAUDITED)
<S> <C> <C>
ASSETS
CURRENT
Cash and short-term deposits $ 6,710 $ 4,256
Accounts receivable 12,839 10,364
Inventories 9,670 8,134
Executive stock purchase plan loans 2,541 2,512
Deposits and prepaid expenses 1,294 1,063
--------- ---------
33,054 26,599
FIXED ASSETS 24,838 24,819
OTHER ASSETS 7,051 7,188
--------- ---------
$64,943 $58,606
========= =========
LIABILITIES
CURRENT
Bank indebtedness $ 3,717 $ -
Accounts payable 5,824 5,468
Accrued liabilities 1,882 1,738
Income taxes payable 989 808
Customer prepayments 4,151 6,681
Current portion of long-term debt 1,950 2,298
--------- ---------
18,513 16,993
LONG-TERM DEBT 4,010 4,670
--------- ---------
22,523 21,663
--------- ---------
SHAREHOLDERS' EQUITY
Share capital 14,505 14,614
Retained earnings 28,262 22,712
Cumulative Translation account (347) (383)
--------- ---------
42,420 36,943
--------- ---------
$64,943 $58,606
========= =========
</TABLE>
<PAGE> 1
[BIOVAIL LETTERHEAD] EXHIBIT "E"
FOR: Biovail Corporation International
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
Chief Financial Officer
(416) 285-6000
CONTACT: Investor Relations: Donna Stein/
Dan Durkin/Cindy Hintelmann
Press: Stacy Berns
FOR IMMEDIATE RELEASE Morgen-Walke Associates
(212) 850-5600
BIOVAIL FILES VERELAN GENERIC ANDA
- REPRESENTS SECOND ANDA FILING FOR BIOVAIL IN 1997 -
TORONTO, Canada, April 30, 1997 -- Biovail Corporation International
(NYSE, TSE:BVF) today confirmed that it has submitted an Abbreviated New Drug
Application (ANDA) for its controlled release generic version of Verelan, a
calcium channel blocker for the treatment of hypertension. Verelan sales in
North America currently approximate $130 million.
The submission represents the second ANDA filing for Biovail in 1997,
following the recent filing of a generic version of Cardizem CD, also a calcium
channel blocker used for the treatment of hypertension.
Eugene Melnyk, Chairman of the Board, commented, "We have begun 1997 on a
very positive note with our success in completing studies required for these
two filings. Once again, this reaffirms our commitment to growth in the rapidly
expanding controlled release market. We now have four ANDAs filed with the FDA
and are confident that our product 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.
####
{BIOVAIL LETTERFOOT}
