valeant pharmaceuticals international, inc. form 6-k

VALEANT PHARMACEUTICALSINTERNATIONAL, INC.FORM 6-K(Report of Foreign Issuer)Filed 08/15/96 for the Period Ending 06/30/96Telephone 514-744-6792CIK 0000885590Symbol VRXSIC Code 2834 - Pharmaceutical PreparationsIndustry Biotechnology & DrugsSector HealthcareFiscal Year 12/31http://www.edgar-online.com© Copyright 2012, EDGAR Online, Inc. All Rights Reserved.Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, DC 20549FORM 6-KREPORT OF FOREIGN ISSUER PURSUANT TO RULE 13A - 16 AND 15D - 16 OF THESECURITIES ACT OF 1934For Quarter Ended June 30, 1996 Commission File Number 001-11145BIOVAIL 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) 285-6000Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-FForm 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 tothe commission pursuant to Rule 12g 3-2 (b) under the Securities Exchange Act of 1934.Yes __ No X

BIOVAIL CORPORATION INTERNATIONALQUARTERLY REPORTINDEXPART 1. FINANCIAL INFORMATIONConsolidated Balance Sheets, June 30, 1996 andDecember 31, 1995 .............................................. 1Consolidated Statements of Incomefor the three and six months ended June 30, 1996 and 1995 ...... 2Consolidated Statements of Cash Flows for the sixmonths ended June 30, 1996 and 1995 ............................ 3Notes to Consolidated Financial Statements ......................... 4Management's Discussion and Analysis of FinancialCondition and Results of Operations ............................ 6PART 11. OTHER INFORMATION ...................................... 9(All dollar amounts in this document are expressed in US dollars unless otherwise stated.)

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED BALANCE SHEETS(All dollar amounts are expressed in thousands of US dollars)JUNE 30, DECEMBER 31,1996 1995----------- ------------(Unaudited) (Audited)ASSETSCURRENTCash and short-term deposits $21,936 $24,323Trade accounts receivable 8,578 6,379Inventories 7,346 3,868Deposits and prepaid expenses 768 176------- -------38,628 34,746FIXED ASSETS, net 22,386 19,910GOODWILL, net 3,494 3,594PRODUCT RIGHTS, net 2,563 2,617------- -------$67,071 $60,867======= =======LIABILITIESCURRENTAccounts payable $ 6,579 $ 5,628Accrued liabilities 4,980 3,043Income taxes payable 906 968Deferred revenue 20,434 22,167Current portion of long-term debt 2,827 2,244------- -------35,726 34,050DEFERRED REVENUE -- 4,274LONG-TERM DEBT 6,867 7,951------- -------42,593 46,275SHAREHOLDERS' EQUITYShare capital 14,568 14,489Retained Earnings, (deficit) 9,865 (572)Cumulative translation adjustment 45 675------- -------24,478 14,592------- -------$67,071 $60,867======= =======The accompanying notes are an integral part of the consolidated financial statements.

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED STATEMENTS OF CASH FLOWS(All dollar amounts are expressed in thousands of U.S. dollars)(Unaudited)SIX MONTHS ENDEDJUNE 30,--------------------1996 1995------- -------NET INFLOW (OUTFLOW) OF CASHRELATED TO FOLLOWING ACTIVITIESOPERATINGNet income $10,437 $ 1,851Depreciation and amortization 993 588------- -------11,430 2,439Change in non-cash operating items (Note 2) (9,350) (248)------- -------2,080 2,191INVESTINGAdditions to fixed assets (3,351) (541)------- -------(3,351) (541)FINANCINGIssuance of share capital 99 84Increase in long-term debt 249 2,831Reduction in long-term debt (737) (393)------- -------(389) 2,522------- -------EFFECT OF EXCHANGE RATE CHANGES ON CASH (727) 428------- -------INCREASE (DECREASE) IN CASH (2,387) 4,600CASH AND SHORT-TERM DEPOSITS, BEGINNING OFPERIOD 24,323 2,819------- -------CASH AND SHORT-TERM DEPOSITS, END OF PERIOD $21,936 $ 7,419======= =======The accompanying notes are an integral part of the consolidated financial statements.

1. SIGNIFICANT ACCOUNTING POLICIESBIOVAIL CORPORATION INTERNATIONALNOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS(All dollar amounts are expressed in thousands of U.S. dollars)(Unaudited)Biovail Corporation International (the "Company"), was amalgamated effective March 29, 1994, under the laws of the province of Ontario. TheCompany's accounting and reporting policies conform to generally accepted accounting principles in Canada. There were no materialdifferences between generally accepted accounting principles in Canada and generally accepted accounting principles in the United States inthe reporting periods.Royalty revenue is recognized on an accrual basis in accordance with the contractual agreements with third parties and is net of amountspayable to sublicensees.Certain of 1995 figures have been reclassified to conform to the 1996 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 endedDecember 31, 1995.In the opinion of management, all adjustments necessary for a fair presentation of the financial position, results of operations and cash flowsfor the period presented have been made and all such adjustments are of a normal recurring nature.2. CHANGE IN NON-CASH OPERATING WORKING CAPITALSIX MONTHS ENDED JUNE 30,(IN THOUSANDS)--------------------------1996 1995------- -------Accounts receivable $(2,191) $ 2,413Inventory (3,456) 207Deposits and prepaid expenses (593) (487)Accounts payable and accrued liabilities 2,922 (383)Amount due on acquisition -- (975)Income taxes payable (61) 36Deferred revenue (5,971) (1,059)------- -------$(9,350) $ (248)======= =======

3. CONTINGENCIESOn November 12, 1993, a patent infringement lawsuit was commenced in the U.S. District Court, for the District of New Jersey, by MarionMerrell Dow, Inc. ("MMD"), Carderm Capital LP and Elan Corporation plc ("Elan") against Hoechst-Roussel Pharmaceuticals, Inc.("Hoechst").Hoechst was licensed at that time by the Company for the once-daily controlled release formulation of Diltiazem. The complaint alleged thatHoechst had infringed on certain patents relating to a controlled absorption diltiazem formulation and sought, among other things, to enjoinHoechst from infringing.As a result of the Settlement Agreement among Hoechst, MMD and Carderm Capital LP, that suit was discontinued on behalf of thoseplaintiffs. However, Elan has continued this suit as sole plaintiff.The Company has answered Elan's allegations of patent infringement by denying any such infringement and by asserting that, in any event,Elan's patents are invalid and therefore unenforceable. The Company has received a legal opinion that Elan's lawsuit is without merit, and it hasaccordingly launched an Application for a summary dismissal of Elan's complaint. The Company has also commenced a substantialcounterclaim against Elan.4. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLESThe 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"). Whereas, except in the case of adjustments with respect to translating amounts to U.S. dollars, these items are appropriatelyincluded in the Company's consolidated statement of income and deficit under Canadian GAAP, they would be reflected as capital transactionsunder U.S. GAAP.RECONCILIATION OF NET INCOME UNDERCANADIAN AND U.S. GAAPSIX MONTHS ENDED JUNE 30,(IN THOUSANDS EXCEPT PER SHARE DATA)1996 1995Net income as shown in the consolidated statement of income and deficit $ 10,437 $ 1,851Use of weighted average rate for the year versus year end rate forpurposes of translating net income amounts from Canadian dollars(the currency of measurement) to U.S. dollars (the reporting currency) (8) (20)-------- --------Net income according to U.S. GAAP $ 10,429 $ 1,831======== ========Earnings per share under U.S. GAAP $ 0.39 $ .07======== ========Weighted average number of common shares outstanding under U.S. GAAP (1) 26,763 26,250======== ========1) The weighted average number of common shares outstanding for purposes of the computation of the earnings per share under U.S. GAAPgives 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 June 30, 1996, or December 31,1995.

MANAGEMENT'S DISCUSSION AND ANALYSIS OFFINANCIAL CONDITION AND RESULTS OF OPERATIONS(All dollar amounts are expressed in U.S. dollars)OVERVIEWThe Company derives its revenues from; (1) the development and licensing of oral controlled release products using its proprietary drugdelivery technology;(2) the manufacture of such drugs for sale to licensees; (3) the royalties from sales by licensees of Company developed products; and (4)providing contract research services including pharmacokinetic studies, bioanalytical laboratory testing, and clinical research studies andregulatory services.The Company's profitability in a given year is directly impacted by the level of its research and product development activities. Such costs arecharged to earnings in the year they are incurred notwithstanding the fact that the benefits therefrom are not realized until later periods whenthe products under development are licensed and brought to market and revenues are generated from royalties based on the level of sales andmanufacturing revenues are generated through the retention of manufacturing rights.RESULTS OF OPERATIONSContract research revenue in the 1996 first half was $2,344,000 as compared to $2,857,000 in the 1995 first half. The first half of 1995included a cancellation fee payment for a special study by a former Tiazac(R) licensee. Excluding that payment, revenues for the ContractResearch Division were approximately equal over the comparable periods.Manufacturing revenue was $27,901,000 in the 1996 first half as compared to $1,254,000 in the 1995 first half. The 1996 manufacturingrevenue was related to the manufacture of supplies of Tiazac(R) for the Company's licensee Forest Laboratories Inc. ("Forest"). The 1995manufacturing revenue was derived from the sale of launch supplies of Tiazac(R) to the Company's previous licensee, Hoechst-RousselPharmaceuticals.In the 1996 first half, royalty and licensing revenue was $4,332,000 as compared to $3,689,000 in the 1995 first half.Royalty revenue increased to $4,332,000 in the 1996 first half period from $2,689,000 in the 1995 first half period. The increase in royaltyrevenues are primarily due to the launch of Tiazac(R) by Forest in the United States and increased Oruvail sales volumes in the United Statesby Wyeth-Ayerst Laboratories.Revenue from the licensing of new products was nil in the 1996 first half as compared to $1,000,000 in the 1995 first half. The licensingrevenue received in 1995 relates to the assignment and licensing rights for Tiazac(R) to the Company's previous licensee.

The gross margin on contract revenue was 20% in the 1996 first half as compared to 42% in the 1995 first half. The 1995 gross margin wasfavourably impacted due to the inclusion of $567,000 of non-refundable prepaid amounts related to the cancellation of a special study by aformer licensee; excluding this amount the gross margin for the 1995 first half was 27%.The gross margin on manufacturing revenue was 58% in the 1996 first half, as compared to 61% in the 1995 first half. The 1996 margin wasimpacted by the manufacture of both trade and sample supplies of Tiazac(R) compared to only trade supplies in 1995.Research and product development expenses increased to $4,015,000 in the 1996 first half from $1,458,000 in the 1995 first half, primarily dueto increased levels of product development activities and as a result of the establishment and staffing of the Toronto R & D facility.Selling, general and administrative expenses increased to $6,254,000 in the 1996 first half compared to $3,218,000 in the 1995 first half. Theperiod to period increases are primarily as a result of the commencement of the Canadian sales operation, increased activities associated withthe manufacturing facilities and increased corporate expenses due to the hiring of key management personnel.Operating income of $10,736,000 was achieved in the 1996 first half as compared to operating income of $968,000 in the 1995 comparableperiod. Canadian operations incurred losses of $5,611,000 in 1996 as compared to operating losses of $1,245,000 in 1995. Operating income of$2,129,000 and $1,307,000 in each of the 1996 and 1995 periods respectively was earned by the Company's subsidiary in Switzerland throughroyalties earned on the Company's products. Barbados contributed operating income of $14,218,000 in the 1996 first half compared to$906,000 in the 1995 comparable period. The increased operating contribution in Barbados is due to the sales of Tiazac(R).Net interest income was $321,000 in the 1996 first half as compared to interest expense of $224,000 in the 1995 first half. The interest incomein 1996 was earned as a result of surplus cash and a lower level of interest bearing debt.Income taxes in the 1996 first half increased to $620,000 from $23,000 in the 1995 first half period as a result of increased operating income.In the 1996 first half, the Company reported net income of $10,437,000, or $0.41 per share. This compares to net income of $1,851,000 or$0.07 per share in the 1995 first half, which included a gain on licensing settlement of $1,130,000 or $0.04 per share. Earnings per share havebeen calculated using the weighted average number of shares outstanding during each period and take into effect the 3 for 1 stock splitcompleted in January, 1996.

LIQUIDITY AND CAPITAL RESOURCESFor the six months ended June 30, 1996, the Company generated $2,080,000 in cash-flow from operating activities compared to $2,191,000 inthe 1995 comparable period. Cash generated was as a result of income from operations (after adding back non-cash charges) of $11,430,000and $2,439,000 in the 1996 first half and 1995 first half respectively, and a decrease in non-cash operating items of $9,350,000 and $248,000 inthe two respective periods.Net cash of $389,000 was used in financing activities in the 1996 first half, compared to a provision of net cash of $2,522,000 in the 1995 firsthalf. The 1996 cash utilization was as a result of long-term debt repayments of $737,000, offset in part by the issuance of common shares for$99,000 and increases in long-term debt of $249,000. In the same period of 1995, cash provided was due to the issuance of common shares for$84,000, increases in long-term debt of $2,831,000, offset in part by long-term debt repayments of $393,000.Investing activities related to additions to fixed assets of $3,351,000 in the 1996 first half compared to $541,000 in the 1995 first half.Exchange rate changes on foreign cash balances resulted in a U.S. dollar cash equivalent reduction of $727,000 in the 1996 first half, comparedto an increase of $428,000 in the 1995 first half.As a result of the foregoing, cash balances decreased to $21,936,000 as at June 30, 1996, from $24,323,000 as at December 31, 1995, butincreased from $7,419,000 as at June 30, 1995.The Company's total long-term debt was $9,694,000 as at June 30, 1996 as compared to $10,195,000 at December 31, 1995. Long-term debt atJune 30, 1996, is comprised of $6,068,000 related to the manufacturing facility located in Manitoba, Canada; $1,795,000 is a mortgage payableon its laboratory facility; and $1,831,000 is a bank term loan. With respect to the debt relating to the manufacturing facility, an aggregateamount of $3,034,000 is a non-interest bearing loan from a Canadian government agency and $3,034,000 is a construction loan from aCanadian chartered bank. The Company has available a line of credit of $1,500,000 for short-term financing.The Company believes it has adequate capital and sources of financing to support its ongoing operational requirements. Furthermore, theCompany believes it will be able to obtain long-term capital, if necessary, to support its growth objectives.INFLATIONInflation has not had a material impact on the Company's operations.The Company does not currently engage in hedging or other activities to reduce exchange rate risk but may do so in the future, if conditionswarrant.

BIOVAIL CORPORATION INTERNATIONALPART II - OTHER INFORMATION1. OPERATIONAL INFORMATIONThe press releases issued by the Company in the 1996 second quarter are attached as the following exhibits:a) On April 3, 1996, the Company announced the regulatory approval of its Tiazac(R) product in the United Kingdom by the MedicinesControl Agency.b) On April 17, 1996, the Company reports its 1996 First Quarter Financial results.c) On May 22, 1996, the Company announced that the Soros led Investor Group acquired 20% of the Company previously held by ForestLaboratories.d) On July 17, 1996, the Company reported its 1996 Second Quarter and Six Month Financial results.e) On July 22nd, 1996, the Company announced that it has been issued a U.S. patent on the Company's Diltiazem Delivery System.2. LEGAL PROCEEDINGSFor detailed information concerning legal proceedings, reference is made to Note 3 in the financial statement contained as part hereof.

SIGNATURESPursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by theundersigned thereunto duly authorized.Biovail Corporation InternationalAugust 15, 1996By Robert A. Podruzny------------------------------Robert A. PodruznyVice President - Finance andChief Financial Officer

[BIOVAIL LOGO]EXHIBIT "A"FOR:APPROVED BY:CONTACT:BIOVAIL CORPORATION INTERNATIONALEugene MelnykChairman of the BoardBob PodruznyChief Financial Officer(416) 285-6000Investor Relations: Donna Stein/Courtney Levi/Cindy HintelmannPress: Michael McMullanMorgen-Walke Associates(212) 850-5600FOR IMMEDIATE RELEASEBIOVAIL CORPORATION'S TIAZAC(R) APPROVED IN UNITED KINGDOM;ADDITIONAL APPROVALS ACCEPTED IN SECOND HALF 1996-INITIAL EUROPEAN SHIPMENTS IN FOURTH QUARTER 1996-TORONTO, Canada, April 3, 1996 -- Biovail Corporation International (AMEX, TSE:BVF) today announced that it has received approvalfrom the Medicines Control Agency (MCA) to market all five dosage strengths of Tiazac(R), its once-daily formulation of diltiazem, in theUnited Kingdom. The Company expects to announce its initial European marketing partners during the second quarter of 1996, with an initialproduct rollout in the U.K. anticipated in the fourth quarter of 1996.Eugene Melnyk, Chairman of the Board, commented, "We are excited to have received our first international approval to market Tiazac(R) inEngland. This acceptance serves as a springboard for securing additional approvals for Tiazac(R) throughout the European Community (EC).The EC represents an overall growing calcium channel blocker market of about $2.3 billion, of which diltiazem represents approximately $400million. In keeping with our strategy to obtain optimum market share for Tiazac(R), we will specifically target those countries with the highestmarket potential, in particular France, Italy, Germany and Spain."- more -[RECYCLE LOGO]BIOVAIL CORPORATION INTERNATIONAL460 COMSTOCK ROAD, TORONTO, ONTARIO, CANADA M1L 4S4TEL (416) 285-6000 FAX (416) 285-6499

"With this approval," continued Mr. Melnyk, "we will accelerate our international licensing program and begin manufacturing product to fillinitial stocking programs for the fourth quarter of 1996. We expect early European sales to begin contributing to Biovail's sales and earnings bythe end of this year, with a much stronger impact in 1997 as more approvals are obtained and additional licensing agreements are reached." TheCompany is currently registering Tiazac(R) in the balance of the EC using the decentralized mutual recognition procedure, a process whichshould be completed by the fourth quarter of 1996.Mr. Melnyk concluded, "Forest Laboratories' aggressive rollout of Tiazac(R) in the U.S., initiated in late February, is being spearheaded byheavy promotion and advertising to physicians specializing in the treatment of hypertension. Our initial feedback is very positive; with newprescriptions being written and filled, a trend that we anticipate will escalate rapidly in subsequent quarters. To meet this growing demand, weare ramping up and expanding our production capabilities in Puerto Rico and Manitoba, 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.###

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED STATEMENTS OF INCOME AND DEFICIT(All amounts except per share data are expressed in thousands of U.S. dollars)THREE MONTHS ENDEDYEAR ENDEDDECEMBER 31, DECEMBER 31,------------------------ ------------------------1995 1994 1995 1994---------- ---------- ---------- ----------REVENUEContract $ 574 $1,208 $4,333 $3,909Manufacturing 6,685 4,479 7,915 4,975Royalty and licensing 2,220 2,660 8,321 8,404---------- ---------- ---------- ----------9,479 8,347 20,569 17,288---------- ---------- ---------- ----------EXPENSESCost of contract revenue 461 806 2,732 3,036Cost of goods sold 2,238 1,824 2,715 2,102Research and product development 1,665 740 4,462 2,542Selling, general and administrative 1,911 2,151 7,182 6,359Royalty and commission 364 92 925 724---------- ---------- ---------- ----------6,639 5,613 18,016 14,763---------- ---------- ---------- ----------OPERATING INCOME 2,840 2,734 2,553 2,525INTEREST INCOME (EXPENSE), net 214 (217) (99) (589)GAIN ON LICENSING SETTLEMENT -- -- 3,617 --GAIN ON DEBT SETTLEMENT -- -- -- 7,955---------- ---------- ---------- ----------INCOME BEFORE INCOME TAXES 3,054 2,517 6,071 9,891PROVISION FOR INCOME TAXES 164 211 201 430---------- ---------- ---------- ----------NET INCOME $2,890 $2,306 $5,870 $9,461========== ========== ========== ==========EARNINGS PER SHARE $ 0.12 $ 0.11 $ 0.23 $ 0.43========== ========== ========== ==========WEIGHTED AVERAGE NUMBER OFCOMMON SHARES OUTSTANDING 24,993,000 21,850,000 24,993,000 21,850,000========== ========== ========== ==========

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED BALANCE SHEETS(All dollar amounts are expressed in thousands of U.S. dollars)DECEMBER 31, DECEMBER 31,1995 1994------------ ------------ASSETSCURRENTCash and short-term deposits $24,323 $ 2,819Trade accounts receivable 6,379 5,346Inventories 3,868 480Deposits and prepaid expenses 176 57------- -------34,746 8,702FIXED ASSETS, net 19,910 14,182GOODWILL, net 3,594 2,746PRODUCT RIGHTS, net 2,617 -------- -------$60,867 $25,630======= =======CURRENTLIABILITIESAccounts payable $ 5,628 $ 2,864Accrued liabilities 3,043 1,794Income taxes payable 968 736Deferred revenue 22,167 1,239Amount due on acquisition - 955Current portion of long-term debt 2,244 567------- -------34,050 8,155------- -------DEFERRED REVENUE 4,274 -------- -------LONG-TERM DEBTNon-interest bearing and forgivableinterest government loans 2,019 4,717Other 5,932 5,065------- -------7,951 9,782------- -------46,275 17,937------- -------SHAREHOLDERS' EQUITYShare capital 14,489 13,415Deficit (572) (6,442)Cumulative translation adjustment 675 720------- -------14,592 7,693------- -------$60,867 $25,630======= =======

[BIOVAIL LOGO]EXHIBIT "B"FOR:APPROVED BY:CONTACT:BIOVAIL CORPORATION INTERNATIONALEugene MelnykChairman of the BoardBob PodruznyChief Financial Officer(416) 285-6000Investor Relations: Donna Stein/Courtney Levi/Cindy HintelmannPress: Michael McMullanMorgen-Walke Associates(212) 850-5600FOR IMMEDIATE RELEASEBIOVAIL CORPORATION INTERNATIONAL REPORTS RECORD 1996 FIRSTQUARTER FINANCIAL RESULTSTORONTO, Canada, April 17, 1996 --- Biovail Corporation International (AMEX, TSE:BVF) today reported record first quarter financialresults for the period ended March 31, 1996.Revenues for the first quarter of 1996 increased 207% to $16.9 million, compared with $5.5 million reported for the first quarter of 1995.Operating income rose 246% to $4.9 million in the first quarter of 1996, compared with $1.4 million in the first quarter of 1995. Net income forthe first quarter of 1996 was $4.7 million, or $0.18 per share, compared with net income of $1.3 million, or $0.05 per share in the comparableperiod of 1995. Weighted average number of common shares outstanding were 25.3 million compared to 24.8 million in 1995 (on a post-split3-for-1 basis).-more-[RECYCLE LOGO]BIOVAIL CORPORATION INTERNATIONAL460 COMSTOCK ROAD, TORONTO, ONTARIO, CANADA M1L 4S4TEL (416) 285-6000 FAX (416) 285-6499

"We are extremely pleased with our strong start in 1996," stated Eugene Melnyk, Chairman of the Board. "The substantial increase in ourquarterly revenues, net income and earnings per share was driven by sales from the formal launch of Tiazac(R) by our U.S. marketing partner,Forest Laboratories. Preliminary results of this launch indicate that Tiazac(R) is successfully penetrating the once-daily diltiazem market, asevidenced by the recent prescription data provided by IMS, a medical market research organization. Forest Laboratories' aggressive promotionand stocking program has placed initial quantities of Tiazac(R) in approximately 55,000 pharmacies across the U.S.""Tiazac(R)'s unique bioequivalence, which allows patients treated on Cardizem CD to switch to Tiazac(R) at the nearest equivalent daily dose,has substantially affected the number of new prescriptions written to date for our product. Also, due to its wider dosing range and attractiveprice, we are confident that Tiazac(R) will continue to gain increased market acceptance both domestically and abroad. As recently announced,we received approval from the Medicines Control Agency (MCA) to market all five dosage strengths of Tiazac(R) in the UK. This marksTiazac(R)'s first international approval," continued Mr. Melnyk.Mr. Melnyk concluded, "In keeping with our strategy of providing optimum shareholder value, during the quarter we announced a 3-for-1 stocksplit which took effect in January. We also strengthened our senior management team, with the hiring of Bob Podruzny (Corporate Finance),Kenneth Cancellara (Legal), Marie-Claire Pilon (International Marketing) and Paul Desjardins Ph.D. (Contract Research), providing theinfrastructure needed for Biovail to continue to grow within the global pharmaceutical community."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.-- Tables Follow --

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED STATEMENTS OF INCOME(All amounts except per share data are expressed in thousands of U.S. dollars)(Unaudited)THREE MONTHS ENDEDMARCH 31,--------------------1996 1995------- -------REVENUEContract $ 1,157 $ 1,829Manufacturing 12,771 1,231Royalty and licensing 2,963 2,441------- -------16,891 5,501------- -------EXPENSESCost of contract revenue 929 995Cost of goods sold 5,464 477Research and productdevelopment 2,039 648Selling, general andadministrative 2,943 1,638Royalty and commission 617 329------- -------11,992 4,087------- -------OPERATING INCOME 4,899 1,414INTEREST INCOME(EXPENSE), net 170 (106)------- -------INCOME BEFORE INCOME TAXES 5,069 1,308INCOME TAXES 382 8------- -------NET INCOME $ 4,687 $ 1,300======= =======EARNINGS PER SHARE $ 0.18 $ 0.05======= =======WEIGHTED AVERAGE NUMBER OFCOMMON SHARES OUTSTANDING 25,343,000 24,826,000========== ==========

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED BALANCE SHEETS(All dollar amounts are expressed in thousands of U.S. dollars)(Unaudited)MARCH 31, DECEMBER 31,1996 1995-------- ------------ASSETSCURRENTCash and short-term deposits $ 28,431 $ 24,323Trade accounts receivable 6,913 6,379Inventories 5,300 3,868Deposits and prepaid expenses 457 176-------- --------41,101 34,746FIXED ASSETS, net 21,157 19,910GOODWILL, net 3,554 3,594PRODUCT RIGHTS, net 2,602 2,617-------- --------$ 68,414 $ 60,867======== ========LIABILITIESCURRENTAccounts payable $ 4,717 $ 5,628Accrued liabilities 6,320 3,043Income taxes payable 883 968Deferred revenue 25,602 22,167Current portion of long-term debt 2,833 2,244-------- --------40,355 34,050-------- --------DEFERRED REVENUE 1,560 4,274-------- --------LONG-TERM DEBT 7,252 7,951-------- --------49,167 46,275-------- --------SHAREHOLDERS' EQUITYShare capital 14,528 14,489Retained earnings (deficit) 4,115 (572)Cumulative translation adjustment 604 675-------- --------19,247 14,592-------- --------$ 68,414 $ 60,867======== ========

[BIOVAIL LOGO]EXHIBIT "C"FOR:APPROVED BY:CONTACT:BIOVAIL CORPORATION INTERNATIONALEugene MelnykChairman of the BoardBob PodruznyChief Financial Officer(416) 285-6000Investor Relations: Donna Stein/Courtney Levi/Cindy HintelmannPress: Michael McMullanMorgen-Walke Associates(212) 850-5600FOR IMMEDIATE RELEASESOROS LED INVESTOR GROUP ACQUIRES 20% BIOVAIL STAKEFROM FOREST LABORATORIESTORONTO, Canada, MAY 22, 1996 -- Biovail Corporation International (AMEX, TSE:BVF) today announced that Quantum Partners, LDC,an investment vehicle advised by Soros Fund Management, and other investors including Oracle Partners, L.P., a leading health careinvestment firm, has acquired all of the common share holdings of Forest Laboratories, Inc. in Biovail.The Company advised that all terms relating to the manufacturing and licensing of Tiazac(R) remain in place and unchanged. However, theOption Agreement, which concerns the Right of First Negotiation with respect to Biovail's future products, has been amended to provide that inthe event Biovail chose to directly market certain products, either itself or through an affiliate, Biovail will now have the right to do so, exceptwith respect to the generic version of Procardia XL(R), whereby Forest Laboratories Inc. will continue to have the Right of First Negotiation,pursuant to the Option Agreement.Eugene Melnyk, Chairman of the Board, Biovail Corporation, commented, "We look forward to continuing our partnership with ForestLaboratories and our working relationship with respect to Tiazac(R), our once-daily formulation of Diltiazem. Early results confirm the initialsuccess of this product launch as evidenced by continued positive prescription data indicating widespread acceptance of Tiazac(R) in the antihypertensivemarket place."Mr. Melnyk also stated, "Biovail's ability to now market its future products gives the Company added flexibility in expanding its role ofmarketer and distributor of its own and other products in the United States."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.###[RECYCLE LOGO]BIOVAIL CORPORATION INTERNATIONAL460 COMSTOCK ROAD, TORONTO, ONTARIO, CANADA M1L 4S4TEL (416) 285-6000 FAX (416) 285-6499

[BIOVAIL LOGO]EXHIBIT "D"FOR:APPROVED BY:CONTACT:BIOVAIL CORPORATION INTERNATIONALEugene MelnykChairman of the BoardBob PodruznyChief Financial Officer(416) 285-6000Investor Relations: Donna Stein/Courtney Levi/Cindy HintelmannPress: Michael McMullanMorgen-Walke Associates(212) 850-5600FOR IMMEDIATE RELEASEBIOVAIL CORPORATION INTERNATIONAL REPORTS RECORD 1996SECOND QUARTER AND SIX MONTH FINANCIAL RESULTSTORONTO, Canada, July 17, 1996 -- Biovail Corporation International (AMEX, TSE:BVF) today reported record second quarter and sixmonth financial results for the period ended June 30, 1996.Revenues for the second quarter of 1996 increased 605% to $18.6 million, compared with $2.6 million reported for the second quarter of 1995.Operating income was $5.9 million in the second quarter of 1996, compared to an operating loss of $472,000 in the second quarter of 1995. Netincome for the second quarter of 1996 was $5.8 million, or $0.23 per share, compared with net income of $528,000, or $0.02 per share in thecomparable period of 1995.Revenues for the six months ended June 30, 1996 increased 330% to $35.5 million compared with $8.2 million reported for the same period of1995. The Company reported operating income for the six months ended June 30, 1996 of $10.7 million, compared with $968,000 for thecomparable period last year. Net income for the six months ended June 30, 1996 was $10.4 million, or $0.41 per share, compared with netincome of $1.9 million, or $0.07 per share in the comparable period of 1995. Weighted average number of common shares outstanding for thefirst half of 1996 were 25,346,000 shares compared with 24,839,000 shares in the same period last year (on a post-split 3-for-1 basis).- more -[RECYCLE LOGO]BIOVAIL CORPORATION INTERNATIONAL460 COMSTOCK ROAD, TORONTO, ONTARIO, CANADA M1L 4S4TEL (416) 285-6000 FAX (416) 285-6499

Eugene Melnyk, Chairman of the Board, commented, "We are very pleased to report a second consecutive quarter of record earnings whichexceeds all analysts' estimates for Biovail Corporation. We attribute these strong results to the successful launch of Tiazac(R), our once-dailyformulation of diltiazem. To date, we are extremely pleased with our marketing partner Forest Laboratories' sales effort in the U.S., as sales ofTiazac(R) continue on an upward trend. We look forward to our continuing exclusive 16-year supply partnership with Forest Laboratories forTiazac(R).""During the quarter we were excited to receive our first international approval from the Medicines Control Agency to market all five dosagestrengths of Tiazac(R) in the United Kingdom. The Company is currently concluding agreements with multiple European marketing partners,each of which will be a unique agreement involving value-added arrangements. Additionally, we have completed our submissions and remainon schedule with our European Community (EC) Mutual Recognition Filing. The EC represents a growing calcium channel blocker market ofabout $2.3 billion, of which diltiazem represents approximately $400 million. In keeping with our strategy to obtain optimum market share forTiazac(R), we will specifically target those countries with the highest market potential, including France, Italy, Germany and Spain," cited Mr.Melnyk."Biovail Pharma, our Canadian marketing and sales organization, has moved forward and is actively engaged in discussions with potentiallicensees, as well as multi-national partners for other products, while awaiting Canadian approval for Tiazac(R)," added Mr. Melnyk.Mr. Melnyk continued, "Also, as recently announced, Quantum Partners, LDC, an investment vehicle advised by Soros Fund Management, andother investors including Oracle Partners, L.P., a leading health care investment firm, acquired all of the common share holdings of ForestLaboratories, Inc. in Biovail. We are pleased with this vote of confidence from Quantum Partners."- more -

"Finally, we continue to make progress with several other products in our pipeline. We anticipate that the Company will enter into a licensingand distribution agreement for Nifedipine OD, a generic version of Procardia XL(R) prior to the end of this year. In addition, we expect aregistration filing by year-end for Verapamil OD, a generic version of Verelan SR(R). We remain confident that Tiazac(R) will continue to winwidespread acceptance within the anti-hypertensive market place, and also look forward to achieving new milestones with respect to ourproduct pipeline, in the coming quarters." concluded Mr. Melnyk.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.--Tables Follow--

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED STATEMENTS OF INCOME(All dollar amounts except per share data are expressed in thousands of U.S. dollars)(Unaudited)THREE MONTHS ENDEDSIX MONTHS ENDEDJUNE 30, JUNE 30,-------------------------- --------------------------1996 1995 1996 1995---- ---- ---- ----REVENUEContract $ 1,190 $ 995 $ 2,344 $ 2,857Manufacturing 15,160 -- 27,901 1,254Royalty and licensing 2,250 1,643 5,207 4,129---------- ---------- ---------- ----------18,600 2,638 35,452 8,240---------- ---------- ---------- ----------EXPENSESCost of contract revenue 950 656 1,876 1,670Cost of manufactured goods sold 6,244 -- 11,696 486Research and product development 1,980 798 4,015 1,458Selling, general and administrative 3,317 1,551 6,254 3,218Royalty and commission 259 105 875 440---------- ---------- ---------- ----------12,750 3,110 24,718 7,272---------- ---------- ---------- ----------OPERATING INCOME (LOSS) 5,850 (472) 10,736 968INTEREST INCOME (EXPENSE), net 151 (115) 321 (224)GAIN ON LICENSING SETTLEMENT -- 1,130 -- 1,130---------- ---------- ---------- ----------INCOME BEFORE INCOME TAXES 6,001 543 11,057 1,874PROVISION FOR INCOME TAXES 239 15 620 23---------- ---------- ---------- ----------NET INCOME $ 5,762 $ 528 $ 10,437 $ 1,851========== ========== ========== ==========EARNINGS PER SHAREIncome (loss) before gain on licensing settlement $ 0.23 $ (0.02) $ 0.41 $ 0.03========== ========== ========== ==========Net income $ 0.23 $ 0.02 $ 0.41 $ 0.07========== ========== ========== ==========WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 25,346,000 24,839,000 25,346,000 24,839,000========== ========== ========== ==========

BIOVAIL CORPORATION INTERNATIONALCONSOLIDATED BALANCE SHEETS(All dollar amounts are expressed in thousands of U.S. dollars)JUNE 30, DECEMBER 31,1996 1995----------- ------------(Unaudited)ASSETSCURRENTCash and short-term deposits $21,936 $24,323Trade accounts receivable 8,578 6,379Inventories 7,346 3,868Deposits and prepaid expenses 768 176------- -------38,628 34,746FIXED ASSETS, net 22,386 19,910GOODWILL, net 3,494 3,594PRODUCT RIGHTS, net 2,563 2,617------- -------$67,071 $60,867======= =======LIABILITIESCURRENTAccounts payable $ 6,579 $ 5,628Accrued liabilities 4,980 3,043Income taxes payable 906 968Deferred revenue 20,434 22,167Current portion of long-term debt 2,827 2,244------- -------35,726 34,050DEFERRED REVENUE -- 4,274LONG-TERM DEBT 6,867 7,951------- -------42,593 46,275------- -------SHAREHOLDERS' EQUITYShare capital 14,568 14,489Retained earnings, (deficit) 9,865 (572)Cumulative translation adjustment 45 675------- -------24,478 14,592------- -------$67,071 $60,867======= =======

[BIOVAIL LOGO]EXHIBIT "E"FOR:APPROVED BY:CONTACT:BIOVAIL CORPORATION INTERNATIONALEugene MelnykChairman of the BoardBob PodruznyChief Financial Officer(416) 285-6000Investor Relations: Donna Stein/Courtney Levi/Cindy HintelmannPress: Michael McMullanMorgen-Walke Associates(212) 850-5600FOR IMMEDIATE RELEASEBIOVAIL CORPORATION INTERNATIONAL RECEIVES PATENT ON DILTIAZEMDELIVERY SYSTEM - TIAZAC(R) PATENT VALID UNTIL JUNE 2013TORONTO, Canada, July 22, 1996 --- Biovail Corporation International (AMEX, TSE:BVF) today announced that it has been issued a U.S.patent covering the use of an extended release drug delivery system for Diltiazem and salt thereof. Patent number 5,529,791 applies to beadscontaining Diltiazem and a wetting agent being coated with microporous membrane comprising a water-soluble polymer.In accordance with the Food and Drug Administration (FDA) regulations, Biovail has filed relevant information concerning the Company'scontrolled release formulation requesting that the FDA publish the patent information provided in its List of Approved Drug Products (theOrange Book).Eugene Melnyk, Chairman of the Board of Biovail Corporation, stated, "We are pleased with this newest development concerning Tiazac(R)and wish to applaud the efforts of Messrs. Baudier, DeBoeck and their team of scientists. This patent, which expires in June of 2013, providesfurther protection of our recently acquired technologies developed by Galephar, Puerto Rico Inc., Ltd."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.###[RECYCLE LOGO]BIOVAIL CORPORATION INTERNATIONAL460 COMSTOCK ROAD, TORONTO, ONTARIO, CANADA M1L 4S4TEL (416) 285-6000 FAX (416) 285-6499End of Filing© 2005 | EDGAR Online, Inc.