<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 JUNE 30, 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, JUNE 30, 1997 AND
DECEMBER 31, 1996...................................................... 1
CONSOLIDATED STATEMENTS OF INCOME
FOR THE SIX MONTHS ENDED JUNE 30, 1997 AND 1996........................ 2
CONSOLIDATED STATEMENTS OF CASH FLOW
FOR THE SIX MONTHS ENDED JUNE, 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.)
<PAGE> 3
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
<TABLE>
<CAPTION>
JUNE 30, DECEMBER 31,
1997 1996
----------- -----------
(UNAUDITED)
<S> <C> <C>
ASSETS
Current
Cash and short-term deposits $ 6,774 $ 4,526
Accounts receivable 21,442 10,364
Inventories 8,969 8,134
Executive stock purchase plan loans (Note 3) 2,573 2,512
Deposits and prepaid expenses 3,169 1,063
------- -------
42,927 26,599
Fixed Assets 25,232 24,819
Other Assets 7,423 7,188
------- -------
$75,582 $58,606
======= =======
LIABILITIES
Current
Bank indebtedness (Note 5) $ 9,332 $ -
Accounts payable 3,914 5,468
Accrued liabilities 4,909 1,738
Income taxes payable 846 808
Customer prepayments 1,173 6,681
Current portion of long-term debt 1,956 2,298
------- -------
22,130 16,993
Long-term Debt 3,659 4,670
------- -------
25,789 21,663
------- -------
SHAREHOLDERS' EQUITY
Share capital 14,847 14,614
Retained earnings 35,340 22,712
Cumulative translation adjustment (394) (383)
------- -------
49,793 36,943
------- -------
$75,582 $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 SIX MONTHS, ENDED
JUNE 30, JUNE 30,
----------------------------- -----------------------------
1997 1996 1997 1996
---------- ---------- ---------- ----------
<S> <C> <C> <C> <C>
REVENUE
Contract $ 1,419 $ 1,190 $ 2,159 $ 2,344
Manufacturing 15,247 15,160 28,537 27,901
Royalty and licensing 1,784 1,991 4,146 4,332
---------- ---------- ---------- ----------
18,450 18,341 34,842 34,577
---------- ---------- ---------- ----------
EXPENSES
Cost of contract revenue 710 950 1,194 1,876
Cost of manufactured goods sold 3,858 6,244 8,181 11,696
Research and product development 2,300 1,980 5,365 4,015
Selling, general and administrative 4,078 3,317 6,725 6,254
10,946 12,491 21,465 23,841
---------- ---------- ---------- ----------
OPERATING INCOME 7,504 5,850 13,377 10,736
INTEREST INCOME (EXPENSE), NET (51) 151 (66) 321
---------- ---------- ---------- ----------
INCOME BEFORE INCOME TAXES 7,453 6,001 13,311 11,057
PROVISION FOR INCOME TAXES 375 239 683 620
---------- ---------- ---------- ----------
NET INCOME $ 7,078 $ 5,762 $12,628 $10,437
========== ========== ========== ==========
EARNINGS PER SHARE (NOTE 6) $ 0.28 $ 0.23 $ 0.50 $ 0.41
========== ========== ========== ==========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 25,435,000 25,346,000 25,435,000 25,346,000
========== ========== ========== ==========
</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>
SIX MONTHS ENDED
JUNE 30,
---------------------------
1997 1996
------- -------
<S> <C> <C>
NET INFLOW (OUTFLOW) OF CASH
RELATED TO THE FOLLOWING ACTIVITIES
OPERATING
Net income for the period $ 12,628 $10,437
Depreciation and amortization 1,431 993
-------- -------
14,059 11,430
Change in non-cash operating items (Note 2) (17,946) (9,350)
-------- -------
(3,887) 2,080
-------- -------
INVESTING
Additions to fixed assets, net (1,703) (3,351)
Increase in other assets (495) -
-------- -------
(2,198) (3,351)
-------- -------
FINANCING
Issuance of share capital 337 99
Increase in long-term debt - 249
Reduction in long-term debt (1,304) (737)
-------- -------
(967) (389)
-------- -------
EFFECT OF EXCHANGE RATE
CHANGES ON CASH (32) (727)
-------- -------
DECREASE IN CASH (7,084) (2,387)
CASH, BEGINNING OF PERIOD 4,526 24,323
-------- -------
(BANK INDEBTEDNESS) CASH, END OF PERIOD $ (2,558) $21,936
======== =======
REPRESENTED BY
Cash and short-term deposits $ 6,774 $21,936
Bank indebtedness (Note 5) (9,332) -
-------- -------
$ (2,558) $21,936
======== =======
</TABLE>
The accompanying notes are an integral part of the consolidated financial
statements
3
<PAGE> 6
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.
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>
Six Months ended June 30,
(In Thousands)
-------------------------
1997 1996
-------- -------
<S> <C> <C>
Accounts receivable $(11,089) $(2,191)
Inventories (834) (3,456)
Executive stock purchase plan loans (63) -
Deposits and prepaid expenses (2,106) (593)
Accounts payable and accrued liabilities 1,615 2,922
Income taxes payable 38 (61)
Customer prepayments (5,507) (5,971)
-------- -------
$(17,946) $(9,350)
======== =======
</TABLE>
3. EXECUTIVE STOCK PURCHASE PLAN LOANS
Executive stock purchase plan loans as at June 30, 1997 consist of loans
of $2,573,000 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
<PAGE> 7
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 available lines of credit of $45,000,000 for short-term
financing with a Canadian chartered bank of which $9,332,000 was utilized as at
June 30, 1997
6. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES
The items included in the table below give rise to differences in earnings
per share under generally accepted accounting principles in the United States
("U.S. GAAP").
<TABLE>
<CAPTION>
Six Months ended March 31,
(In Thousands except per share data)
-----------------------------
1997 1996
------- -------
<S> <C> <C>
Net income under U.S. and Canadian GAAP $12,628 $10,437
======= =======
Earnings per share under U.S. GAAP $0.47 $0.39
======= =======
Weighted average number of common shares outstanding under US. GAAP 26,891 26,763
======= =======
</TABLE>
There are no differences between shareholders' equity determined under Canadian
and U.S. GAAP at either June 30, 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 (i) developing 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 six months ended June 30, 1997 were $34,842,000 compared with
$34,577,000 in the comparable period in 1996. While the 1997 revenue increase
was small, a sales mix change with respect to Tiazac(R) resulted in a larger
improvement in manufacturing margins and net income, as described below. As a
result, net income for the first six months of 1997 of $12,628,000 represented
a 21% improvement over net income of $10,437,000 in the comparable period in
1996.
Revenue realized by the Contract Research Division (the "CRD") from third-party
customers was $2,159,000 in the six months ended June 30, 1997, compared to
$2,344,000 in the comparable period in 1996. Revenues decreased in the first
six months of 1997 as a result of the CRD having performed more services for
Biovail and fewer services for third parties. The operating margin on the
CRD's services to third parties was 45% in the six months ended June 30, 1997,
compared to 20% in the comparable period in 1996 as a result of cost
reductions and a more profitable mix of services.
Manufacturing revenues of $28,537,000 were generated on sales of Tiazac(R) in
the six months ended June 30, 1997, compared to $27,901,001 in the comparable
period in 1996. In the six months ended June 30, 1997, U.S. "trade sales"
(sales other than sample sales) were approximately 80% of total unit sales as
compared to only 40% in the comparable period in 1996. Trade supplies are sold
at a slightly higher price than sample sales and also have a lower cost of
manufacture due to lower packaging and labor costs, resulting in a higher
margin for trade sales. In addition, the Company launched Tiazac(R) in Canada
in 1997, accounting for approximately 20% of total manufacturing revenues in
the first six months of 1997. Canadian sales are at a higher margin than U.S.
sales due to the direct sale by the Company's distribution subsidiary, Crystaal
Corporation ("Crystaal"), as opposed to U.S. sales, which are made through a
third-party distributor. As a result of the higher percentage of trade sales,
launch of Tiazac(R) in Canada and improved manufacturing efficiencies, the
manufacturing margin increased to 71% in the first six months of 1997, as
compared to 58% in the comparable period in 1996.
Royalty revenue, net of royalty expenses, totaled $4,146,000 in the six months
ended June 30, 1997, compared to $4,332,000 in the comparable period in 1996.
Net royalty revenues decreased relative to the first six months of 1996 as a
result of royalties paid to Galephar on Canadian Tiazac(R) sales by Crystaal in
the first six months of 1997.
6
<PAGE> 9
Research and product development expenditures were $5,365,000 in the six months
ended June 30, 1997, an increase from $4,015,000 in the comparable period in
1996, reflecting significant activity on the development of pipeline products.
Selling, general and administrative costs were $6,725,000 in the six months
ended June 30, 1997, an increase from $6,254,000 in the comparable period in
1996, primarily as a result of promotional costs related to the launch of
Tiazac(R) in Canada.
LIQUIDITY AND CAPITAL RESOURCES
As at June 30, 1997, the Company's working capital was $20,797,000 compared to
$9,606,000 at December 31, 1996 which represented a working capital ratio of
1.9:1 as compared to 1.6:1 respectively.
The Company had negative cash flow of $3,887,000 in the six months ended June
30, 1997, compared to positive cash flow of $2,080,000 in the comparable
period in 1996. Cash generated from operations was $14,059,000 and
$11,430,000 in the six months ended June 30, 1997 and 1996, respectively.
Working capital requirements in 1997 exceeded the cash flow generated from
operations.
For the first six months of 1997 and 1996, cash flow from investing activities
was $2,198,000 and $3,351,000 respectively, in each case, representing
primarily additions to fixed assets.
In the six months ended June 30, 1997, $1,304,000 of long-term debt was repaid
and proceeds of $337,000 were received from the issuance of common shares. In
the comparable period in 1996, net long-term debt repayments were $488,000, and
proceeds of $89,000 were received from the issuance of common shares.
Exchange rate changes on foreign cash balances resulted in a reduction of
cash of $32,000 in the six months ended June 30, 1997, compared to a
reduction of $727,000 in the comparable period in 1996.
As a result of the foregoing, the Company's cash as of June 30, 1997, was
$6,774,000, compared to $4,526,000 and $21,936,000, at December 31, 1996 and
June 30, 1996, respectively.
The Company's total long-term debt was $5,615,000 as at June 30, 1997 compared
to $6,968,000 at December 31, 1996 and $9,694,000 at June 30, 1996. In
addition, the Company has available lines of credit aggregating $45,000,000
for short-term financing, of which $9,332,000 was utilized as at June 30 ,
1997, and none was utilized as of December 31, 1996.
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.
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 second quarter are
attached as the following exhibits:
a) 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.
b) 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).
c) On April 30, 1997, the Company confirmed the ANDA filing for Generic
Verelan in the U.S.
d) On July 24, 1997, the Company reported its 1997 Second Quarter
and Six Month Financial Results.
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> 11
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
August 5, 1997 By /s/ Robert A.Podruzny
----------------------------
Robert A. Podruzny
Vice President, Finance and
Chief Financial Officer
9
<PAGE> 1
Exhibit "A"
[BIOVAIL LETTERHEAD]
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 statement 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.
# # #
[RECYCLE LOGO]
[BIOVAIL LETTERFOOT]
<PAGE> 1
Exhibit "B"
[BIOVAIL LETTERHEAD]
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."
-- More --
[RECYCLE LOGO]
[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 exited 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 form
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
----------- ------------
ASSETS (UNAUDITED)
<S> <C> <C>
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 $ 3,717 $ --
Bank indebtness 5,824 5,468
Accounts payable 1,882 1,738
Accrued liabilities 989 808
Income taxes payable 4,151 6,681
Customer prepayments 1,950 2,298
------- -------
Current portion of long-term debt 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
Exhibit "C"
[BIOVAIL LETTERHEAD]
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 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.
# # #
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[BIOVAIL LETTERFOOT]
<PAGE> 1
Exhibit "D"
[BIOVAIL LETTERHEAD]
FOR: BIOVAIL CORPORATION INTERNATIONAL
APPROVED BY: Eugene Melnyk
Chairman of the Board
Bob Podruzny
Chief Financial Officer
(416) 285-6000
FOR IMMEDIATE RELEASE
BIOVAIL REPORTS RECORD 1997 SECOND QUARTER
AND SIX MONTH FINANCIAL RESULTS
TORONTO, Canada, July 24, 1997 -- Biovail Corporation International (NYSE,
TSE:BVF) today reported second quarter and six month financial results for the
period ended June 30, 1997.
Revenues for the second quarter of 1997 were $18.5 million, compared to
$18.3 in the second quarter of 1996. Record operating income of $7.5 million was
achieved representing a 28% increase over last year's operating income of $5.9
million. Net income for the second quarter of 1997 was $7.1 million, or $0.28
per share, compared with net income of $5.8 million or $0.23 per share in 1996.
The increase in net income was primarily due to improved manufacturing margins
as a result of the Company's successful launch of Tiazac(R) in Canada in the
quarter.
Revenues for the six months ended June 30, 1997 were $34.8 million compared
to $34.6 million in 1996. Net income of $12.6 million, or $0.50 per share,
increased by 21% over last year's net income of $10.4 million, or $0.41 per
share. The improvement in the 1997 six month result is primarily due to the
combination of the successful launch of Tiazac(R) in Canada in the second
quarter and a higher proportion of trade vs sample sales of Tiazac(R) in the
U.S. throughout the six month period.
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[BIOVAIL LETTERFOOT]
<PAGE> 2
Eugene Melnyk, Chairman of the Board, commented, "We are very pleased with
the continually improving financial performance of the Company that meets or
exceeds analysts' expectations. The success of Tiazac(R)'s penetration of the
U.S. diltiazem market is unquestioned, and expected further market share gains
will fuel growth of the Company in the coming quarters. The successful launch of
Tiazac(R) in Canada in the second quarter by the Company's subsidiary, Crystaal
Corporation, as well as the product's launch in the U.K. by our marketing
partner, Dupont Merck Pharmaceutical Co., significantly broadens the geographic
base for Tiazac(R)'s expected continued growth."
Mr. Melnyk concluded, "The Company is well positioned to take advantage of
future opportunities. The continuing success of Tiazac(R); the expected success
of Biovail's generic controlled release versions of Cardizem SR, Cardizem CD,
Trental and Verelan currently pending FDA approval; and the potential of the
Company's additional eight products in various stages of development, will all
contribute to the ongoing success of 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 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>
JUNE 30, DECEMBER 31,
1997 1996
----------- ------------
(UNAUDITED)
<S> <C> <C>
ASSETS
Current
Cash and short-term deposits $ 6,774 $ 4,526
Accounts receivable 21,150 10,364
Inventories 8,968 8,134
Executive stock purchase plan loans 2,865 2,512
Deposits and prepaids 3,169 1,063
------- -------
42,927 26,599
Fixed Assets 25,232 24,819
Other Assets 7,423 7,188
------- -------
$75,582 $58,606
======= =======
LIABILITIES
Current
Bank indebtness $ 9,332 $ --
Accounts payable 3,913 5,468
Accrued liabilities 4,909 1,738
Income taxes payable 846 808
Customer prepayments 1,173 6,681
Current portion of long-term debt 1,956 2,298
------- -------
22,130 16,993
Long-Term Debt 3,659 4,670
------- -------
25,789 21,663
------- -------
SHAREHOLDERS' EQUITY
Share capital 14,847 14,614
Retained earnings 35,340 22,712
Cumulative translation adjustment (394) (383)
------- -------
49,793 36,943
------- -------
$75,582 $58,606
======= =======
</TABLE>
<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 SIX MONTHS ENDED
JUNE 30, JUNE 30,
1997 1996 1997 1996
--------- ---------- ---------- -----------
<S> <C> <C> <C> <C>
REVENUE
Contract $ 1,419 $ 1,190 $ 2,159 $ 2,344
Manufacturing 15,247 15,160 28,537 27,901
Royalty and licensing 1,784 1,991 4,146 4,332
---------- ----------- ---------- -----------
18,450 18,341 34,842 34,577
---------- ----------- ---------- -----------
EXPENSES
Cost of contract revenue 710 950 1,194 1,876
Cost of manufactured goods sold 3,858 6,244 8,181 11,696
Research and product development 2,300 1,980 5,365 4,015
Selling, general and administrative 4,078 3,317 6,725 6,254
---------- ---------- ---------- -----------
10,946 12,491 21,465 23,841
---------- ---------- ---------- -----------
OPERATING INCOME 7,504 5,850 13,377 10,736
INTEREST INCOME (EXPENSE), net (51) 151 (66) 321
---------- ----------- --------- ----------
INCOME BEFORE INCOME TAXES 7,453 6,001 13,311 11,057
PROVISION FOR INCOME TAXES 375 239 683 620
---------- ---------- ---------- ----------
NET INCOME $ 7,078 $ 5,762 $ 12,628 $ 10,437
========== ========== ========== ==========
EARNINGS PER SHARE $ 0.28 $ 0.23 $ 0.50 $ 0.41
========== ========== ========== ==========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 25,435,000 25,346,000 25,435,000 25,346,000
========== ========== ========== ==========
</TABLE>
