-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, R9JwMCX4mmt7I/v/uOGFOx0FE3hRciyybpnENTiqIUUFY4AlHrDx8Uus63HNqos8 tir7soPtOoVdSj93JGQNyA== 0000950150-98-000934.txt : 19991027 0000950150-98-000934.hdr.sgml : 19991027 ACCESSION NUMBER: 0000950150-98-000934 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 18 CONFORMED PERIOD OF REPORT: 19980331 FILED AS OF DATE: 19980529 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOVAIL CORPORATION INTERNATIONAL CENTRAL INDEX KEY: 0000885590 STANDARD INDUSTRIAL CLASSIFICATION: 2834 IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: SEC FILE NUMBER: 001-14956 FILM NUMBER: 98634328 BUSINESS ADDRESS: STREET 1: 2488 DUNWIN DR STREET 2: MISSISSIAUGA CITY: ONTARIO STATE: A6 BUSINESS PHONE: 4162856000 MAIL ADDRESS: STREET 1: 2488 DUNWIN DR STREET 2: MISSISSAUGA CITY: ONTARIO STATE: A6 6-K 1 FORM 6-K 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 6-K REPORT OF FOREIGN ISSUER PURSUANT TO RULE 13A - 16 AND 15D - 16 OF THE SECURITIES ACT OF 1934 FOR QUARTER ENDED MARCH 31, 1998 COMMISSION FILE NUMBER 001-11145 BIOVAIL CORPORATION INTERNATIONAL (TRANSLATION OF REGISTRANT'S NAME IN ENGLISH) 2488 DUNWIN DRIVE, MISSISSAUGA, ONTARIO L5L 1J9, CANADA (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES AND ZIP CODE) REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (416) 285-6000 INDICATE BY CHECK MARK WHETHER THE REGISTRANT FILES OR WILL FILE ANNUAL REPORTS UNDER COVER OF FORM 20-F OR FORM 40-F FORM 20-F X FORM 40-F __ INDICATE BY CHECK MARK WHETHER FOR REGISTRANT BY FURNISHING THE INFORMATION CONTAINED IN THIS FORM IS ALSO HEREBY FURNISHING THE INFORMATION TO THE COMMISSION PURSUANT TO RULE 12G 3-2 (B) UNDER THE SECURITIES EXCHANGE ACT OF 1934. YES __ NO X 2 BIOVAIL CORPORATION INTERNATIONAL QUARTERLY REPORT INDEX PART 1. FINANCIAL INFORMATION CONSOLIDATED BALANCE SHEETS, MARCH 31, 1998 AND DECEMBER 31, 1997................................................1 CONSOLIDATED STATEMENTS OF INCOME FOR THE THREE MONTHS ENDED MARCH 31, 1998 AND 1997 ..............2 CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31, 1998 AND 1997 ............................3 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS ..............................4 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS .............................7 PART 11.OTHER INFORMATION ..............................................10
(ALL DOLLAR AMOUNTS IN THIS DOCUMENT ARE EXPRESSED IN US DOLLARS UNLESS OTHERWISE STATED.) 3 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED BALANCE SHEETS (ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
MARCH 31, DECEMBER 31, 1998 1997 ----------- ------------ (UNAUDITED) ASSETS Current Cash and short-term deposits $ 11,248 $ 8,275 Accounts receivable 36,359 33,114 Inventories 18,981 16,609 Executive loans (Note 3) 2,720 2,933 Deposits and prepaids 2,132 2,053 -------- ------- 71,440 62,984 Long-term investments (Note 4) 7,500 -- Fixed Assets, net 24,680 24,172 Other Assets, net (Note 5) 21,215 6,583 -------- ------- $124,835 $93,739 ======== ======= LIABILITIES Current Accounts payable 7,189 4,579 Accrued liabilities 3,724 6,002 Income taxes payable 1,146 1,013 Customer prepayments 6,352 1,840 Current portion of long-term debt 1,791 1,887 -------- ------- 20,202 15,321 Long-term Debt (Note 6) 17,483 2,960 -------- ------- 37,685 18,281 -------- ------- SHAREHOLDERS' EQUITY Share capital 22,215 18,465 Warrants 8,244 8,244 Retained earnings 57,557 49,709 Cumulative translation adjustment (866) (960) -------- ------- 87,150 75,458 -------- ------- $124,835 $93,739 ======== =======
The accompanying notes are an integral part of the consolidated financial statements. 1 4 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED STATEMENTS OF INCOME (ALL DOLLAR AMOUNTS EXCEPT PER SHARE DATA ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS) (UNAUDITED)
THREE MONTHS ENDED MARCH 31, 1998 1997 ----------- ------------ REVENUE Research and development $ 7,844 $ 740 Manufacturing 11,467 13,290 Royalty and licensing 2,578 2,362 ----------- ----------- 21,889 16,392 ----------- ----------- EXPENSES Research and development 4,029 3,549 Cost of manufactured goods sold 5,142 4,323 Selling, general and administrative 4,311 2,647 ----------- ----------- 13,482 10,519 ----------- ----------- OPERATING INCOME 8,407 5,873 INTEREST INCOME (EXPENSE), net (68) (15) ----------- ----------- INCOME BEFORE INCOME TAXES 8,339 5,858 PROVISION FOR INCOME TAXES 491 308 ----------- ----------- NET INCOME $ 7,848 $ 5,550 =========== =========== EARNINGS PER SHARE (Note 8) $ 0.29 $ 0.22 =========== =========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING $26,736,000 $25,430,000 =========== ===========
The accompanying notes are an integral part of the consolidated financial statements. 2 5 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED STATEMENTS OF CASH FLOWS (ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS) (UNAUDITED)
THREE MONTHS ENDED MARCH 31, 1998 1997 --------- --------- NET INFLOW (OUTFLOW) OF CASH RELATED TO THE FOLLOWING ACTIVITIES OPERATING Net income for the period $ 7,848 $ 5,550 Depreciation and amortization 1,164 689 -------- -------- 9,012 6,239 Change in non-cash operating items (Note 2) (616) (6,045) -------- -------- 8,396 194 -------- -------- INVESTING Acquisition of royalty interest (Note 5) (15,000) -- Long-term investments (Note 4) (7,500) -- Additions to fixed assets, net (1,207) (780) Executive loans (Note 3) 213 (30) -------- -------- (23,494) (810) -------- -------- FINANCING Increase in long-term debt (Note 6) 15,000 -- Issuance of share capital 3,660 37 Reduction in long-term debt (597) (939) -------- -------- 18,063 (902) -------- -------- EFFECT OF EXCHANGE RATE CHANGES ON CASH 8 (15) -------- -------- INCREASE (DECREASE) IN CASH 2,973 (1,533) CASH, BEGINNING OF PERIOD 8,275 4,526 -------- -------- CASH, END OF PERIOD $ 11,248 $ 2,993 ======== ======== REPRESENTED BY Cash and short-term deposits $ 11,248 $ 6,710 Bank indebtedness -- (3,717) -------- -------- $ 11,248 $ 2,993 ======== ========
The accompanying notes are an integral part of the consolidated financial statements 3 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 except for those described in Note 8. 1997 Figures Certain of the 1997 figures have been reclassified to conform to the 1998 presentation. For a full description of the other accounting policies of the Company, reference is made to the Annual Report on Form 20-F for the year ended December 31, 1997. In the opinion of management, all adjustments necessary for a fair presentation of the financial position, results of operations and cash flows for the period presented have been made and all such adjustments are of a normal recurring nature. 2. CHANGE IN NON-CASH OPERATING WORKING CAPITAL
Three Months ended March 31, (In Thousands) --------------------------- 1998 1997 ------- ------- Accounts receivable............................... $(3,191) $(2,451) Inventories....................................... (2,332) (1,521) Deposits and prepaids............................. (78) (231) Accounts payable and accrued liabilities.......... 339 504 Income taxes payable.............................. 135 183 Customer prepayments.............................. 4,511 (2,529) ------- ------- $ (616) $(6,045) ======= =======
4 7 3. EXECUTIVE LOANS Executive loans as at March 31, 1998 consist of Executive Stock Purchase Plan ("ESPP") loans of $2,720,000 made to finance the acquisition of shares of the Company on the open market by executive officers. The loans are secured by shares of the Company owned by the executive officers, bear interest at 1/4% over the prime rate which is equal to the Company's rate for borrowings, and are due on December 1, 1998. 4. LONG-TERM INVESTMENTS In March, 1998, the Company made a $7,500,000 investment in a marketable securities fund. The term of the investment is two years. 5. OTHER ASSETS In March, 1998, the Company completed the acquisition of the royalty interest of Galephar Puerto Rico, Inc., Limited ("Galephar") in certain of the Company's products. The Company paid $15,000,000 to Galephar in full satisfaction of the Company's royalty obligation on the sales of Tiazac(R) and the Company's generic controlled release version of Cardizem CD in the United States and Canada. 6. LONG-TERM DEBT In March, 1998, the Company utilized a $15,000,000 revolving term bank loan to acquire the royalty interest of Galephar (See Note 5). The loan is secured by a general security agreement bearing interest at the bank's London Interbank Offer Rate ("LIBOR"), plus 1 1/2 %. The Company may make repayments on the loan at any time. 7. LITIGATION From time to time, the Company becomes involved in various legal matters which it considers to be in the ordinary course of business. While the Company is not currently able to determine the potential liability, if any, related to such matters, the Company believes none of the matters, individually or in the aggregate, will have a material adverse effect on its financial position. 5 8 8. UNITED STATES GENERALLY ACCEPTED ACCOUNTING PRINCIPLES The financial statements of the Company have been prepared in accordance with generally accepted accounting principles in Canada ("Cdn GAAP") which differ in certain respects from those applicable in the United States ("U.S. GAAP"). The material differences as they apply to the Company's financial statements are as follows: a) Reconciliation of net income under Cdn. and U.S. GAAP
THREE MONTHS ENDED MARCH 31, (IN THOUSANDS EXCEPT PER SHARE DATA) ------------------------------------ 1998 1997 ---- ---- Net income under Cdn. GAAP......................... $7,848 $5,550 U.S. GAAP adjustments: Collection of warrant subscription receivable...... (147) - ------ ------ Net income under U.S. GAAP......................... $7,701 $5,550 ====== ====== Earnings per share under U.S. GAAP Basic.............................................. $0.29 $0 .22 Diluted............................................ $0.27 $0 .21 Weighted average number of common shares outstanding under U.S. GAAP Basic.............................................. 26,736 25,430 Diluted............................................ 28,386 26,970
b) The components of shareholders' equity under U.S. GAAP are as follows:
MARCH 31, 1998 DECEMBER 31, 1997 -------------- ----------------- Share Capital.......................... $22,215 $18,465 Warrants............................... 8,244 8,244 Warrant subscription receivable, net... (7,347) (7,494) Retained earnings...................... 64,904 57,203 Cumulative translation adjustment...... (866) (960) ------- ------- $87,150 $75,458 ======= =======
6 9 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (ALL DOLLAR AMOUNTS ARE EXPRESSED IN U.S. DOLLARS) OVERVIEW Biovail Corporation International ("Biovail" or the "Company") derives its revenues from (i) developing, marketing and licensing oral controlled release products using its proprietary drug delivery technologies; (ii) manufacturing such products for sale to licensees and wholesalers; and (iii) providing pharmaceutical contract research services to third parties. RESULTS OF OPERATIONS Revenues for the first quarter of 1998 were $21,889,000 compared with $16,392,000 in 1997. The increase was primarily due to increased research and development revenue from third parties and milestone revenue from a subsidiary of Teva Pharmaceuticals Industries Ltd. ("Teva") related to the Company's filing of a generic version of Adalat CC with the FDA. Net income increased 41% to $7,848,000, or $0.29 per share, in the first quarter of 1998 compared with net income of $5,550,000 or $0.22 in 1997. Research and development revenue from third-party customers was $7,844,000 in the first quarter of 1998, compared to $740,000 in 1997. The increase in revenue was due to product development activities on behalf of Teva as stated above and Intelligent Polymers Limited ("IPL"). Research and development expenses for the first quarter of 1998 were $4,029,000 as compared to $3,549,000 in 1997. The increased spending over 1997 reflects the Company's increased level of research and development activity for third party customers. Manufacturing revenues for the first quarter of 1998 were $11,467,000 compared to $13,290,000 in 1997. In 1998 revenues were generated primarily on sales of Tiazac(R) to Forest Laboratories ("Forest") for the U.S. market, Canadian market sales of Tiazac(R) by the Company's subsidiary Crystaal Corporation ("Crystaal") and the shipment of prelaunch quantities of product to Teva in accordance with terms of the agreement. The decrease in manufacturing revenue from 1997 was due primarily to the expected one time contractual price reduction to Forest of 25% which occurred at the end of the second quarter of 1997. As a result of the price reduction to Forest, product mix and manufacturing volumes, the cost of manufactured goods increased to 45% of revenue in the first quarter of 1998 as compared to 33% in 1997. Royalty and licensing revenue, net of related expenses, totaled $2,578,000 in the first quarter of 1998, compared to $2,362,000 in 1997. Net royalties increased 9% in 1998 as compared to 1997 as a result increased Tiazac(R) sales in the U.S. market and the elimination, net of related amortization expense, of the Company's royalty obligation on Tiazac(R) sales previously payable to Galephar Puerto Rico, Inc., Limited ("Galephar"). Selling, general and administrative expenses increased to $4,311,000 in the first quarter of 1998, compared to $2,647,000 in 1997. The period to period increase is primarily as a result of 7 10 increased levels of activity in the Company, including sales and marketing expenses related to the launch of Tiazac(R) in Canada, the registration costs associated with Tiazac(R) in the European markets and the hiring of key management personnel. Operating income of $8,407,000 was achieved in the first quarter of 1998 compared to operating income of $5,873,000 in 1997. Canadian operations (including Crystaal, manufacturing and contract research facilities, research and development and corporate administrative functions) incurred an aggregate operating loss of $5,296,000 in the first quarter of 1998 compared to $2,221,000 in 1997. This increase in operating losses is due primarily to sales and marketing costs associated with the sale of Tiazac(R) in Canada. Operating income of $773,000 and $1,260,000 in each of the 1998 and 1997 periods respectively was earned by the Company's subsidiary in Switzerland through royalties earned on Biovail's products (excluding Tiazac(R)). Operations in Barbados and Puerto Rico contributed operating income of $12,930,000 in the first quarter of 1998 compared to $6,834,000 in 1997. The increase in operating income in Barbados and Puerto Rico was due primarily to product development fees and manufacturing sales activities. Net interest expense was $68,000 in the first quarter of 1998 compared to $15,000 in 1997. Income taxes in the first quarter of 1998 were $491,000 compared to $308,000 in 1997, which tax provisions are reflective of the geographic sources of income at appropriate rates. LIQUIDITY AND CAPITAL RESOURCES As at March 31, 1998, the Company's working capital was $51,238,000 compared to $47,663,000 at December 31, 1997 which represented a working capital ratio of 3.5:1 as compared to 4.2:1 respectively. The Company had positive cash flow of $8,396,000, for the three months ended March 31, 1998 compared to $194,000 in 1997. Cash generated was as a result of income from operations (after adding back non-cash charges) of $9,012,000 and $6,239,000 in the 1998 and 1997 first quarters respectively. Working capital increased marginally in 1998 due to an increase in accounts receivable related to the launch of Tiazac(R) in Canada, amounts owing from Teva relating to the reimbursement of research and development fees and increases in inventories related to raw material for Tiazac(R) and generic products. Although similar increases in the non-cash components of working capital relative to operating income may occur in the future, the Company believes such increases are temporary in nature and are not expected to have a long-term effect on the Company's cash flow. Investing activities in the first quarter of 1998 relate to the acquisition of the royalty interest from Galephar for $15,000,000, long-term investments of $7,500,000 and additions to fixed assets of $1,207,000, offset by a net repayment of executive loans of $213,000. In the comparable 1997 period investing activities included additions to fixed assets of $780,000 and loans fof $30,000 to executive officers. 8 11 Net cash was generated from financing activities of $18,063,000 in the first quarter of 1998 compared to net cash used in financing activities of $902,000 in 1997. The 1998 cash generated was as a result of a net increase in long-term debt of $14,403,000 and $3,660,000 received from the issuance of common shares on the exercise of stock options. The increase in long-term debt was the result of the Company's financing the acquisition of the royalty interest from Galephar. In the comparable period in 1997, cash utilization was as a result of net long-term debt repayments of $939,000 offset by proceeds of $37,000 received from the issuance of common shares on the exercise of stock options. Exchange rate changes on foreign cash balances resulted in an increase in cash of $8,000 in the first quarter of 1998 compared to a reduction of cash of $15,000 in 1997. As a result of the foregoing, the Company's cash position as at March 31, 1998 was $11,248,000 compared to $2,993,000 at March 31, 1997. The Company's total long-term debt (including current portions thereof) was $19,274,000 as at March 31, 1998 compared to $4,847,000 at December 31, 1997. In addition, the Company has available lines of credit aggregating $30,000,000 for immediate financing requirements. As of March 31, 1998, there were no outstanding borrowings against these lines of credit. The Company believes it has adequate capital and sources of financing to support its ongoing operational requirements. Furthermore, the Company believes it will be able to obtain long-term capital, if necessary, to support its growth objectives. There can be no assurance, however, that the Company's capital and sources of financing or its ability to obtain additional capital or sources of financing, at acceptable terms, will be sufficient to sustain the Company's ongoing operational requirements or its growth objectives. The Company and its subsidiaries generate revenue and expenses primarily in U.S. and Canadian dollars. In the first quarter of 1998, revenue was generated in the following proportions: 85% in U.S. dollars, 14% in Canadian dollars and 1% in other currencies. In addition expenses were incurred in the following proportions: 75% in U.S. dollars, and 25% in Canadian dollars. The Company does not believe that its exposure to foreign currency exchange risk is significant because of the relative stability of the Canadian dollar to the U.S. dollar. The Company has not historically utilized foreign currency hedging instruments. INFLATION Inflation has not had a material impact on the Company's operations. 9 12 BIOVAIL CORPORATION INTERNATIONAL PART II - OTHER INFORMATION 1. OPERATIONAL INFORMATION The press releases issued by the Company in the 1998 first quarter are attached as the following exhibits: a) On January 15, 1998 the Company confirmed that the chairman of the board filed an amended 13-D reflecting market purchase of shares. b) On January 22, 1998 the Company confirmed that it has submitted an ANDA filing for its generic controlled release version of Adalat CC. c) On February 3, 1998 the Company confirmed that the FDA has approved the use of Tiazac(R) for the treatment of chronic stable angina. d) On February 12, 1998 the Company confirmed that it has submitted an ANDA filing for its generic controlled release version of Procardia XL. e) On February 19, 1998 the Company announced that it has entered into licensing agreements for the sales and marketing of its once daily diltiazem product Tiazac(R) with Crino International S.p.A. in Italy, Laboratorios Richmond in Argentina, Barrenne Industria Farmaceutica, in Brazil and Douglas Pharmaceuticals Ltd. in Australia. f) On February 25, 1998 the Company reported its 1997 Fourth Quarter and Year End Financial Results. g) On March 5, 1998 the Company announced a joint development agreement with Galephar Puerto Rico, Inc., Limited to develop Novel Delivery Systems, and the acquisition of product royalty obligations. h) On March 5, 1998 the Company confirmed that the purchase of the royalty obligations to Galephar Puerto Rico, Inc., Limited would be accretive to earnings. i) On March 12, 1998 the Company announced that its Candian subsidiary Crystaal Corporation acquired the Canadian marketing rights for Brexidol from the Chiesi Group. j) On March 27, 1998 the Company confirmed that the chairman of the board filed an amended 13-D reflecting market purchase of shares. 10 13 k) On April 3, 1998 the Company issued comments on a recent Temporary Restraining Order with respect to the prevention of Mylan Laboratories from launching a genric version of Dilacor XR prior to the expiration of a 180 day period from the launch by Andrx Corporation of its own generic version of the product. l) On April 6, 1998 the Company issued comments on two court proceedings dealing with issues concerning the exclusivity provisions of the Food Drug and Cosmetic Act relating to generic products. m) On April 6, 1998 the Company commented on two court proceeding; Granutec vs. Genpharm et. al. and Mova vs. FDA et. al. The Company also confirmed it has become an Intervenor amicus curiae in Mova vs. FDA et. al. n) On April 15, 1998 the Company commented on court ruling issued by the District of Columbia Court of Appeal on Mova vs. FDA et. al. o) On April 23, 1998 the Company announced that its Canadian subsidiary Crystaal Corporation acquired the Canadian marketing rights for Corlopam from Neurex Corporation. p) On April 29, 1998 the Company reported its 1997 First Quarter Financial Results. q) On May 5, 1998 the Company announced it has signed a licensing agreement with Glaxo Wellcome S.A. for the sales and marketing of the Company's controlled release generic version of Trental in Agrentina, Brazil and Mexico. 2. Legal Proceedings For detailed information concerning legal proceedings, reference is made to Note 7 in the financial statement contained as part thereof. 11 14 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. Biovail Corporation International May 28, 1998 By /s/Kenneth G..Howling Kenneth G. Howling Vice President - Finance and Chief Financial Officer 12 EX-99.A 2 EXHIBIT A 1 EXHIBIT "A" FOR: Biovail Corporation International APPROVED BY: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: - BIOVAIL CONFIRMS CHAIRMAN SHARE PURCHASES - TORONTO, Canada, January 15, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today confirmed that Eugene Melnyk, Chairman of the Board, has filed an amended 13-D reflecting the open market purchase of 122,000 Biovail common shares with personal funds and the exercise of 810,000 stock options for a total purchase of 932,000 shares. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.B 3 EXHIBIT B 1 EXHIBIT "B" CONTACT: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL CONFIRMS GENERIC ADALAT CC FILING* TORONTO, Canada, January 22, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today confirmed that it has submitted an Abbreviated New Drug Application (ANDA) for its generic controlled release version of Adalat CC, a calcium channel blocker for the treatment of hypertension. This once daily brand of Nifedipine extended-release is marketed by Bayer Corporation and represents a $340 million generic opportunity in the U.S. This submission represents the fifth ANDA filing accepted by the FDA for Biovail. Eugene Melnyk, Chairman of the Board, commented, "This filing reaffirms our commitment to growth in the rapidly expanding controlled release market and we are confident that our product development pipeline will afford us the opportunity to bring additional products to market in the coming year." Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.C 4 EXHIBIT C 1 EXHIBIT "C" CONTACT: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL'S TIAZAC(R) APPROVED FOR ANGINA* TORONTO, Canada, February 3, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today confirmed that the Food and Drug Administration (FDA) has approved the use of Tiazac(R), Biovail's branded once daily diltiazem calcium channel blocker, for the treatment of chronic stable angina. Tiazac(R) was approved by the FDA in September 1995 for the treatment of hypertension and is marketed in the U.S. by Forest Laboratories, Inc. The once-daily diltiazem market in the U.S. is in excess of $900 million. Eugene Melnyk, Chairman of the Board, commented, "We are very pleased that Tiazac(R) has successfully captured approximately 12% of newly dispensed prescriptions in the once-daily diltiazem market. With this added indication we are confident that Tiazac(R) is now well positioned to capture greater diltiazem market share, particularly in the managed care segment." Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.D 5 EXHIBIT D 1 EXHIBIT "D" CONTACT: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL CONFIRMS GENERIC PROCARDIA XL FILING* TORONTO, Canada, February 12, 1998 - Biovail Corporation International (NYSE, TSE:BVF) today announced that the Food and Drug Administration (FDA) has accepted an Abbreviated New Drug Application (ANDA) for its generic controlled release version of Procardia XL, a calcium channel blocker for the treatment of hypertension and angina. This once daily brand of Nifedipine is marketed by Pfizer Inc. and represents a generic market opportunity in the U.S. in excess of $800 million. This represents the second ANDA filing accepted by the FDA for Biovail in 1998. Biovail currently has six controlled-release generic products awaiting approval by the FDA representing brand sales in the U.S. in excess of $2.2 billion. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.E 6 EXHIBIT E 1 EXHIBIT "E" CONTACT: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: BIOVAIL NAMES ADDITIONAL TIAZAC(R) INTERNATIONAL LICENSEES TORONTO, Canada, February 19, 1998 - Biovail Corporation International (NYSE, TSE: BVF) announced today that it has entered into licensing agreements covering an additional four countries for the sales and marketing of its once daily diltiazem product Tiazac(R) which is approved for hypertension. The agreements include Italy, Argentina, Brazil and Australia. Excluding North America, Biovail has executed licensing and marketing agreements for Tiazac for thirteen countries with a combined market opportunity in excess of $390 million. Eugene Melnyk, Chairman of the Board, commented, "Variations for the approval of the angina indication have been filed in all European countries where Tiazac(R) is currently approved. We expect the angina indication approval in the very near future." Biovail's additional marketing partners include Crino International S.p.A. for Italy, Laboratorios Richmond for Argentina, Barrenne Industria Farmaceutica for Brazil and Douglas Pharmaceuticals Ltd. for Australia. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.F 7 EXHIBIT F 1 EXHIBIT "F" FOR: Biovail Corporation International APPROVED BY: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: BIOVAIL REPORTS RECORD 1997 FOURTH QUARTER AND YEAR END FINANCIAL RESULTS TORONTO, Canada, February 25, 1998 - Biovail Corporation International (NYSE, TSE:BVF) today reported record fourth quarter and year end financial results for the period ended December 31, 1997. Revenue for the fourth quarter of 1997 increased 89% to $26.3 million compared with $13.9 million reported for the fourth quarter of 1996. Net income for the fourth quarter of 1997 was $13.2 million, or $0.52 per share, compared with net income of $6.5 million, or $0.26 per share in the comparable period of 1996. Revenues for the year end ended December 31, 1997 increased 24% to $82.4 million compared with $66.4 million in 1996. Net income increased 52% for the year ended December 31, 1997 to $35.2 million, or $1.38 per share, compared with net income of $23.2 million, or $0.92 per share, in 1996. Eugene Melnyk, Chairman of the Board, commented, "The past year was marked by several major achievements for Biovail that contribute significantly to the Company's revenue growth and positions Biovail as an industry leader in the development and commercialization of controlled release drug products for the global marketplace." "We have had a very exciting and rewarding year in which record profits were earned, additional international licensing agreements for Tiazac(R) were finalized; regulatory approval for the sale of Tiazac(R) in Canada was received; scientific milestones were achieved with the ANDA filing of major products with the FDA, including Cardizem CD, Verelan and recently Adalat CC and Procardia XL; and the licensing of certain of the Company's ANDA pipeline in Canada. In October we were very successful in raising approximately $75 million through Intelligent Polymers Limited to fund NDA product development. This tremendous year was capped off in December with a major marketing alliance between Biovail and Teva Pharmaceutical Industries Ltd. for the U.S. distribution of Biovail's controlled release generic products." -- More -- 2 Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. 3 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED BALANCE SHEETS (ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
DEC 31, DEC 31, 1997 1996 -------- -------- ASSETS Current Cash and short-term deposits $ 8,275 $ 4,526 Accounts receivable 33,114 10,364 Inventories 16,609 8,134 Executive loans (Note 3) 2,933 2,512 Deposits and prepaids 2,053 1,063 ------- ------- 62,984 26,599 Fixed Assets, net 24,172 24,819 Other Assets, net 6,583 7,188 ------- ------- $93,739 $58,606 ======= ======= LIABILITIES Current Bank Indebtedness (Note 5) $ -- $ -- Accounts payable 4,579 5,468 Accrued liabilities 6,002 1,738 Income taxes payable 1,013 808 Customer prepayments 1,840 6,681 Current portion of long-term debt 1,887 2,298 ------- ------- 15,321 16,993 Long-Term Debt 2,960 4,670 18,281 21,663 ------- ------- SHAREHOLDERS' EQUITY Share capital 18,465 14,614 Retained earnings 57,953 22,712 Cumulative translation adjustment (960) (383) ------- ------- 75,458 36,943 ------- ------- $93,739 $58,606 ======= =======
4 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED STATEMENTS OF INCOME (ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
THREE MONTHS ENDED YEAR ENDED DECEMBER 31 DECEMBER 31 1997 1996 1997 1996 ----------- ----------- ---------- ---------- REVENUE Research and development $ 12,513 $ 1,187 $ 19,559 $ 4,374 Manufacturing 11,429 11,157 50,333 54,313 Royalty and licensing 2,363 1,572 12,487 7,743 ---------- ---------- ---------- ---------- 26,305 13,916 82,379 66,430 ---------- ---------- ---------- ---------- EXPENSES Research and development 2,934 2,403 14,386 10,901 Cost of manufactured goods sold 5,343 3,806 16,471 21,757 Selling, general and administrative 3,914 1,285 13,989 10,166 ---------- --------- ---------- --------- 12,191 7,494 44,846 42,824 ---------- --------- ---------- --------- OPERATING INCOME 14,114 6,422 37,533 23,606 INTEREST INCOME (EXPENSE), net (143) (5) (351) 392 INCOME BEFORE INCOME TAXES 13,971 6,417 37,182 23,998 PROVISION FOR INCOME TAXES 767 (117) 1,941 714 ---------- --------- ---------- --------- NET INCOME $ 13,204 $ 6,534 $ 35,241 $ 23,284 ========== ========= ========== ========= EARNINGS PER SHARE $0.52 $0.26 $ 1.38 $ 0.92 ========== ========= ========== ========= WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 25,606,000 25,378,000 25,606,000 25,378,000 ========== ========== ========== ==========
EX-99.G 8 EXHIBIT G 1 EXHIBIT "G" FOR: Biovail Corporation International CONTACT: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: * BIOVAIL AND GALEPHAR TO DEVELOP NOVEL DELIVERY SYSTEMS * - ALSO ACQUIRES TIAZAC(R) AND OTHER PRODUCT ROYALTY OBLIGATIONS - Toronto, Canada, March 5, 1998--- Biovail Corporation International (NYSE,TSE:BVF) and Galephar Puerto Rico Inc., Limited ("Galephar") today announced a joint development agreement for the application of Galephar's novel tableting technology to Biovail's current products which are in advanced stages of development. This technology will also be applicable to products under development in Intelligent Polymers Limited. The agreement provides for payments of up to $2.5 million by Biovail to Galephar based on certain scientific achievements. In addition, the agreement releases Biovail from its obligation to pay royalties and other fees to Galephar for the sale of Tiazac(R) and its generic controlled release version of Cardizem CD in the United States and Canada in return for a lump sum payment of $15 million. Eugene Melnyk, Chairman of the Board of Biovail, commented "We are very encouraged with the application to date of this novel technology to Biovail's products, certain of which are anticipated to be filed in the coming year. As well, the acquisition of Biovail's royalty obligations to Galephar on Tiazac(R) and generic Cardizem CD sales will be of significant financial benefit going forward by substantially reducing royalty expenses otherwise payable." Biovail Corporation International is an international full-service pharmaceutical company engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.H 9 EXHIBIT H 1 EXHIBIT "H" FOR: Biovail Corporation International CONTACT: Eugene Melnyk Chairman of the Board Bob Podruzny President (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL CONFIRMS $15 MILLION ROYALTY PURCHASE IS ACCRETIVE TO EARNINGS* Toronto, Canada, March 5, 1998--- Biovail Corporation International (NYSE,TSE:BVF) today confirmed that the purchase of its royalty obligation to Galephar Puerto Rico Inc., Limited ("Galephar") will result in a substantial reduction in royalty expense and will be accretive to earnings by approximately $0.15 to $0.20 earnings per share. Biovail has paid $15 million to Galephar in full satisfaction of Biovail's royalty obligation related to the sales of Tiazac(R) and the Company's generic controlled release version of Cardizem CD in the United States and Canada. Biovail Corporation International is an international full-service pharmaceutical company engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.I 10 EXHIBIT I 1 EXHIBIT "I" FOR: Biovail Corporation International CONTACT: Eugene Melnyk Chairman of the Board Kenneth Howling Chief Financial Officer Rolf Reininghaus President, Crystaal Corporation (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL'S SUBSIDIARY, CRYSTAAL, ACQUIRES SIGNIFICANT PRODUCT* - IN-LICENSES BREXIDOL FROM THE CHIESI GROUP - Toronto, Canada, March 12, 1998 --- Biovail Corporation International (NYSE,TSE:BVF) today announced that its Canadian subsidiary, Crystaal Corporation, has entered into a licensing agreement with Italy's Chiesi Group for the marketing in Canada of Brexidol. Brexidol is indicated for the relief of mild to severe acute pain commonly associated with sports injuries and dysmenorrhea. Utilizing Host-Guest chemistry, once daily Brexidol combines a rapid onset of action with a long duration of action. Brexidol is the first medical application of Host-Guest, or supermolecular chemistry, whose researchers were awarded the Nobel Prize in chemistry in 1987. Eugene Melnyk, Chairman of the Board, commented, "Brexidol is the second in-licensing agreement Crystaal has completed and we look forward to concluding additional product marketing arrangements for the Canadian market during 1998. Brexidol will compete in the pain and anti-inflammatory market which is valued at U.S. $150 million annually in Canada and is expected to be approved for marketing by the Canadian authorities this year." The Chiesi Group is one of Italy's premier research based pharmaceutical companies. Its revenues are derived from the sale of pharmaceutical products primarily in the respiratory, cardio-vascular and muscolo-skeletal therapeutic areas. Almost 50% of Chiesi Group's sales are generated in more than 30 markets outside Italy. - more - 2 Biovail Corporation International is an international full-service pharmaceutical company engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.J 11 EXHIBIT J 1 EXHIBIT "J" FOR: Biovail Corporation International APPROVED BY: Eugene Melnyk Chairman of the Board Kenneth Howling Chief Financial Officer (416) 285-6000 FOR IMMEDIATE RELEASE: - BIOVAIL CONFIRMS CHAIRMAN'S SHARE PURCHASES - TORONTO, Canada, March 27, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today confirmed that Eugene Melnyk, Chairman of the Board, has filed an amended 13-D reflecting the open market purchase of 80,000 Biovail common shares with personal funds at prices between $46.887 and $47.75, as well as the intent to purchase over the next twelve months, subject to certain conditions outlined in the 13-D filing, up to an aggregate of an additional 420,000 shares of common stock in open market transactions. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.K 12 EXHIBIT K 1 EXHIBIT "K" CONTACT: Kenneth C. Cancellara Q.C. Senior Vice President General Counsel Eugene Melnyk Chairman of the Board FOR IMMEDIATE RELEASE: (416) 285-6000 *BIOVAIL'S COMMENTS ON RECENT COURT RULING* TORONTO, Canada, April 3, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today commented on a recent Temporary Restraining Order granted by Judge Penn with respect to the prevention of Mylan Laboratories from launching a generic version of Dilacor XR prior to the expiration of a 180 day period from the launch by Andrx Corporation of its own generic version of the product. A recent Andrx press release attempted to imply that Judge Penn's Temporary Restraining Order would somehow influence decisions or could affect the principles currently under consideration by the Court of Appeal for the Fourth Circuit (an appeal from Judge Boyle's decision in Granutec vs. Genpharm et al in which Judge Boyle upheld the FDA's Implementing Regulations) and the Court of Appeal in the District of Columbia (an appeal from Judge Robertson's decision in Mova vs. FDA et al). Legal counsel to the Company has advised Biovail of the following relevant facts: 1. In November 1997, the FDA, in its Notice in the Federal Register formally confirmed that it will continue to follow its Implementing Regulations until the issue of applying exclusivity periods for generic products has come to a final legal conclusion (either in the Courts of Appeal or in the U.S. Supreme Court). The FDA, which was a party to the Andrx action, confirmed its intention to continue implementing its interpretation of the Regulations at the Hearing before Judge Penn. Judge Penn clearly acknowledged that the two Courts of Appeal decisions with respect to the interpretation of the exclusivity provisions in the Food Drug & Cosmetic Act were still pending. His Honour did not, and indeed could not, decide any issue that was under consideration by those higher level courts. Judge Penn's Temporary Restraining Order was specifically restricted to the peculiar factual circumstances in the case before him. The factual situation that gave rise to the recent Temporary Restraining Order issued by Judge Penn is clearly distinguishable from the situations giving rise to the two cases currently pending in the two Courts of Appeal. In Andrx' recent Motion against Mylan and the FDA, 2 Andrx had already enjoyed exclusivity for its Dilacor XR generic product for some 157 days. It was therefore compelling for Judge Penn to allow the status quo to prevail for an additional 13 days (until April 8, 1998). Mylan was unable to demonstrate that, on the balance of convenience, it was entitled to court protection at this late time. 2. Accordingly, there is no applicability of Judge Penn's Temporary Restraining Order to the main issues pending in the two Courts of Appeal. As a further consequence, Judge Penn's decision neither applies to nor is binding upon the ability by Biovail to market its generic Cardizem CD upon approval by the FDA. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.L 13 EXHIBIT L 1 EXHIBIT "L" FOR: Biovail Corporation International APPROVED BY: Eugene Melnyk Chairman of the Board Kenneth C. Cancellara, Q.C General Counsel (416) 285-6000 FOR IMMEDIATE RELEASE: * BIOVAIL COMMENTS ON RECENT COURT PROCEEDINGS * -RECENT RULING DISSIMILAR FROM COMPANY'S FACTUAL CIRCUMSTANCES IN CRITICAL ASPECTS- - COMPANY CONFIRMS IT HAS INTERVENED IN RELEVANT RELATED LITIGATION - TORONTO, Canada, April 6, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today commented on two court proceedings dealing with issues concerning the exclusivity provisions of the Food Drug and Cosmetic Act ("FD&C") relating to generic products. The two relevant court proceedings are Granutec vs. Genpharm et. al. and Mova vs. FDA et. al. Biovail confirmed that the Fourth Circuit Court of Appeal's decision released today in Granutec overturned the decision of the District Court which had upheld FDA's "successful defense" interpretation of the exclusivity provision of the FD&C Act. The Company confirmed its position that the facts applicable to the parties in the Granutec case are dissimilar from Biovail's factual circumstances in a number of critical and key aspects as they relate to Biovail's version of its generic Cardizem CD. As a result, the Company commented that the decision does not squarely rule on the applicability of the exclusivity provisions relating to its filed generic Cardizem CD. Biovail also confirmed today that on March 20, 1998, in a related Court Case it became an Intervenor amicus curiae in Mova v. FDA et. al. at the District of Columbia Court of Appeal level. The Court of Appeal in Mova has accepted for filing Biovail's submission, as it specifically relates to the filing of its generic version of Cardizem CD, is considering Biovail's position, and is expected ultimately to rule on Biovail's specific circumstances in the context of determining all the issues in that Appeal. The most 2 crucial and differentiating fact is that, unlike other ANDA submissions, Biovail was not sued for patent infringement. Biovail reaffirmed its position that any interpretation that does not take into account the built-in abuses and unfairness to legitimate ANDA non-infringing filers when determining the applicability or otherwise of the 180-day exclusivity set forth in the FD&C Act is inappropriate and will be litigated vigorously by the Company. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.M 14 EXHIBIT M 1 EXHIBIT "M" CONTACT: Kenneth C. Cancellara Q.C. Senior Vice President General Counsel Eugene Melnyk Chairman of the Board (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL APPLAUDS COURT RULING* OPINIONS IN MOVA DECISION SUPPORT COMPANY POSITION TORONTO, Canada, April 15, 1998 - Biovail Corporation International (NYSE,TSE:BVF) commented on yesterday's decision and opinions expressed by the District of Columbia Court of Appeal on Mova vs. FDA et al dealing with the exclusivity provisions of the Food, Drug and Cosmetic Act relating to generic products. The Court of Appeal opined on Biovail's specific circumstances, the most crucial of which, unlike other applicants in Mova vs.FDA et al and Granutec vs. Genpharm et al, is that Biovail was not sued for patent infringement when it submitted its Paragraph IV Certification related to its generic version of Cardizem CD. Biovail, who intervened in the Mova litigation and submitted an amicus curiae brief, confirmed that the Court of Appeals' decision upholding the lower court decision relates only to those applicants who have been sued after Certification. In the opinion of the Court, the FDA is encouraged to address the issue of a meritorious or non-litigated subsequent applicant through appropriate regulations or otherwise. The Company therefore anticipates that the FDA review of Biovail's ANDA for a generic version of Cardizem CD will proceed pursuant to the mandate provided in Sectuion 505 (j) (B) (5) (iii) of the Food, Drug and Cosmetic Act. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.N 15 EXHIBIT N 1 EXHIBIT "N" CONTACT: Kenneth C. Cancellara Q.C. Senior Vice President General Counsel Eugene Melnyk Chairman of the Board (416) 285-6000 FOR IMMEDIATE RELEASE: *BIOVAIL APPLAUDS COURT RULING* OPINIONS IN MOVA DECISION SUPPORT COMPANY POSITION TORONTO, Canada, April 15, 1998 - Biovail Corporation International (NYSE,TSE:BVF) commented on yesterday's decision and opinions expressed by the District of Columbia Court of Appeal on Mova vs. FDA et al dealing with the exclusivity provisions of the Food, Drug and Cosmetic Act relating to generic products. The Court of Appeal opined on Biovail's specific circumstances, the most crucial of which, unlike other applicants in Mova vs.FDA et al and Granutec vs. Genpharm et al, is that Biovail was not sued for patent infringement when it submitted its Paragraph IV Certification related to its generic version of Cardizem CD. Biovail, who intervened in the Mova litigation and submitted an amicus curiae brief, confirmed that the Court of Appeals' decision upholding the lower court decision relates only to those applicants who have been sued after Certification. In the opinion of the Court, the FDA is encouraged to address the issue of a meritorious or non-litigated subsequent applicant through appropriate regulations or otherwise. The Company therefore anticipates that the FDA review of Biovail's ANDA for a generic version of Cardizem CD will proceed pursuant to the mandate provided in Sectuion 505 (j) (B) (5) (iii) of the Food, Drug and Cosmetic Act. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.O 16 EXHIBIT O 1 EXHIBIT "O" CONTACT: Eugene Melnyk Chairman of the Board Kenneth Howling Chief Financial Officer Rolf Reininghaus President Crystaal Corporation FOR IMMEDIATE RELEASE: (416) 285-6000 *BIOVAIL'S CRYSTAAL IN-LICENSES CANADIAN RIGHTS TO CORLOPAM FROM NEUREX* TORONTO, Canada, April 23, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today announced that its wholly owned subsidiary, Crystaal Corporation ("Crystaal"), has entered into a licensing agreement with Neurex for the marketing of Corlopam (fenoldopan) in Canada. Corlopam is indicated for the in-hospital management of hypertension when emergency reduction in blood pressure is required. Corlopam is the first of a new pharmacological class of acute care cardiovascular drugs with a novel mechanism of action. Corlopam has been approved by the FDA and was launched commercially in the United States in January, 1998. Crystaal anticipates filing a New Drug Submission with the Therapeutic Products Directorate (T.P.D.) in the second half of this year, with approval expected in late 1999 or early 2000. Rolf Reininghaus, President of Crystaal, commented "Corlopam is the first in a series of acute care products Crystaal is contemplating to in-license. Corlopam will enhance the visibility of Crystaal in hospitals and with leading and influential cardiologists in Canada. It will also provide a positive contribution to earnings. In addition, Corlopam is currently being investigated for additional indications which could provide opportunities for the further use of this medication." Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. EX-99.P 17 EXBIBIT P 1 EXHIBIT "P" CONTACT: Eugene Melnyk Chairman of the Board Ken Howling Chief Financial Officer (416) 285-6000 CONTACT: Eugene Melnyk Chairman of the Board Ken Howling Chief Financial Officer (416) 285-6000 FOR IMMEDIATE RELEASE: * BIOVAIL REPORTS RECORD 1998 FIRST QUARTER FINANCIAL RESULTS * TORONTO, Canada, April 29, 1998 - Biovail Corporation International (NYSE,TSE:BVF) today reported record first quarter financial results for the period ended March 31, 1998. Revenue for the first quarter of 1998 increased 34% to $21.9 million, compared with $16.4 million reported for the first quarter of 1997. Net income for the first quarter of 1998 was $7.9 million, or $0.29 per share, a 41% increase over net income of $5.6 million or $0.22 per share in the comparable period of 1997. Eugene Melnyk, Chairman of the Board, commented, "Our first quarter results demonstrate the Company's focus on continually growing its business, both scientifically and financially. A number of important milestones were achieved in the quarter including the ANDA filings with the FDA of controlled release generic versions of Adalat CC and Procardia XL; the buyout of royalty obligations related to future U.S. and Canadian sales of Tiazac(R) and the Company's generic version of Cardizem CD; and four new licensing agreements for the distribution of Tiazac(R) in Italy, Argentina, Brazil and Australia. Crystaal Corporation, Biovail's wholly-owned Canadian subsidiary, in-licensed two new products for Canada including Brexidol, used in the treatment of pain commonly associated with sports injuries and dysmenorrhea, and Corlopam, used for the in-hospital management of hypertension. Finally, Tiazac(R), currently holding approximately 14 1/2% market share of once-daily diltiazem new prescriptions, was approved by the FDA for chronic stable angina in the quarter, positioning the Company to further improve its diltiazem market share, particularly in the managed care segment. - more - 2 Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. - Tables Follow - 3 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED BALANCE SHEETS (ALL DOLLAR AMOUNTS ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS)
MARCH 31, DECEMBER 31, 1998 1997 --------- ------------ (UNAUDITED) ASSETS Current Cash and short-term deposits $ 11,248 $ 8,275 Accounts receivable 36,359 33,114 Inventories 18,981 16,609 Executive loans 2,720 2,933 Deposits and prepaids 2,132 2,053 -------- ------- 71,440 62,984 Long-term investments 7,500 -- Fixed Assets, net 24,680 24,172 Other Assets, net 21,215 6,583 -------- ------- $124,835 $93,739 ======== ======= LIABILITIES Current Accounts payable 7,189 4,579 Accrued liabilities 3,724 6,002 Income taxes payable 1,146 1,013 Customer prepayments 6,352 1,840 Current portion of long-term debt 1,791 1,887 -------- ------- 20,202 15,321 Long-term Debt 17,483 2,960 -------- ------- 37,685 18,281 ======== ======= SHAREHOLDERS' EQUITY Share capital 22,215 18,465 Warrants 8,244 8,244 Retained earnings 57,557 49,709 Cumulative translation adjustment (866) (960) -------- ------- 87,150 75,458 -------- ------- $124,835 $93,739 ======== =======
The accompanying notes are an integral part of the consolidated financial statements 4 BIOVAIL CORPORATION INTERNATIONAL CONSOLIDATED STATEMENTS OF INCOME (ALL DOLLAR AMOUNTS EXCEPT PER SHARE DATA ARE EXPRESSED IN THOUSANDS OF U.S. DOLLARS) (UNAUDITED)
THREE MONTHS ENDED MARCH 31, 1998 1997 ---------- ----------- REVENUE Research and development $ 7,844 $ 740 Manufacturing 11,467 13,290 Royalty and licensing 2,578 2,362 ---------- ---------- 21,889 16,392 ---------- ---------- EXPENSES Research and development 4,029 3,549 Cost of manufactured goods sold 5,142 4,323 Selling, general and administrative 4,311 2,647 ---------- ---------- 13,482 10,519 ========== ========== OPERATING INCOME 8,407 5,873 INTEREST INCOME (EXPENSE), net (68) (15) ---------- ---------- INCOME BEFORE INCOME TAXES 8,339 5,858 PROVISION FOR INCOME TAXES 491 308 ---------- ---------- NET INCOME $ 7,848 $ 5,550 ========== ========== EARNINGS PER SHARE $ 0.29 $ 0.22 ========== ========== WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 26,736,000 25,430,000 ========== ==========
The accompanying notes are an integral part of the consolidated financial statements EX-99.Q 18 EXHIBIT Q 1 EXHIBIT "Q" CONTACT: Eugene Melnyk Chairman of the Board Kenneth Howling Chief Financial Officer (416) 285-6000 FOR IMMEDIATE RELEASE: * BIOVAIL SIGNS LATIN AMERICAN MARKETING AGREEMENT WITH GLAXO WELLCOME * TORONTO, Canada, May 5, 1998 - Biovail Corporation International (NYSE, TSE: BVF) today announced that it has signed a licensing agreement with Glaxo Wellcome S.A. for the marketing of Biovail's controlled release generic version of Trental(R), (Pentoxifylline) in Argentina, Brazil and Mexico. Trental(R) is prescribed for the treatment of chronic peripheral arterial disease and generates annual sales in excess of $52 million in Latin America. Glaxo Wellcome has an option to market the product in seven additional Latin American markets. Eugene Melnyk, Chairman of the Board, commented, "Biovail continues to exploit its capability of successfully licensing its products in International markets. Latin America is currently one of the fastest growing pharmaceutical markets and Glaxo Wellcome's presence in Latin America is strong. The market dynamics are favorable and launch of the product is anticipated in the first half of 1999." Glaxo Wellcome is a research based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and the healthcare providers that serve them. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA and TPD approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. -----END PRIVACY-ENHANCED MESSAGE-----