Biovail reports first quarter 1997 financial results; confirms ANDA filing for generic Cardizem CD in the U.S.; Signs new European Licensing Agreements for Tiazac.TORONTO, Canada--(BUSINESS WIRE)--April 28, 1997--Biovail Corporation International (NYSE NYSE See: New York Stock Exchange , TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency ) today reported first quarter financial results for the period ended March 31, 1997. The Company also confirmed it has submitted an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for Cardizem Car·di·zem A trademark for the drug diltiazem hydrochloride. diltiazem hydrochloride Adizem (UK), Angitil (UK), Apo-Diltiaz (CA), Apo-Diltiazem (CA), Calcicard (UK), Cardizem, Cardizem CD, Cardizem LA, Cartia XT, CD to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) and has signed additional licensing agreements with European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. partners for Tiazac Tiazac® Diltiazem, see there , Biovail's once-daily formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of the calcium channel blocker calcium channel blocker n. Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders. , diltiazem diltiazem /dil·ti·a·zem/ (dil-ti´ah-zem) a calcium channel blocker that acts as a vasodilator; used as the hydrochloride salt in the treatment of angina pectoris, hypertension, and supraventricular tachycardia. . Revenues for the first quarter of 1997 were $16.4 million, compared with $16.3 million reported for the first quarter of 1996. Net income increased 18% to $5.6 million, or $0.22 per share, in the first quarter of 1997 compared with net income of $4.7 million, or $0.18 per share, in 1996. The prime contributor for the increase in profit was improved margins on Tiazac sales due to the higher proportion of trade vs. sample sales in 1997 compared to 1996. Eugene Melnyk Eugene Melnyk (born May 27, 1959 in Toronto, Ontario) is a Canadian businessman of Ukrainian origin who now resides in Barbados. He is the chairman and chief executive officer of Biovail Corporation. , Chairman, commented, "We are very pleased with our first quarter results which meet or exceed analyst expectations. Continued Tiazac penetration in the U.S. diltiazem market contributed significantly and we anticipate further growth in penetration in coming quarters." Biovail also confirmed that it has submitted an ANDA for a generic version of Cardizem CD to the FDA. This product represents a $700 million market in the U.S. and is marketed by Hoechst Marion Roussel. Mr. Melnyk commented, "This recent ANDA submission is an important milestone for the Company, as we continue to demonstrate our ability to develop important pharmaceutical products with significant market potential. In addition, we successfully completed studies required for an ANDA filing of a generic version of Verelan Verelan® Verapamil, see there , which we expect to submit to the FDA very shortly. With two previously filed ANDAs pending at the FDA, we are very excited about our prospects to bring additional products to market in the coming year." Biovail also has eight other products in advanced stages of development in its product pipeline. In addition, the Company has signed new marketing partnerships for Tiazac in Germany and The Netherlands. In Germany, Biovail signed licensing agreements with Ratiopharm GmbH, a subsidiary of Merckle GmbH, and Heumann GmbH, a division of Searle, USA. Ratiopharm is a leading German generic pharmaceutical company and Heumann is a premiere marketer of pharmaceutical products, with more than 250 sales representatives covering Germany. In The Netherlands, Biovail has signed an agreement with Zambon B.V., a multinational manufacturer and marketer of pharmaceutical, chemical and hospital home care products. The Company reported that new prescription data indicates that Tiazac's market share has increased to 9.3% of new, once-daily diltiazem prescriptions written in the U.S. "Tiazac continues to perform well and is meeting all expectations," said Mr. Melnyk. "In Europe, we have begun shipping product to Dupont Merck, our licensing partner in the United Kingdom and Ireland, and will start to record revenues in the second quarter of 1997. The new licensing agreements announced today are important additions to the strong network we are creating to address the European Community European Community: see European Union. European Community (EC) Organization formed in 1967 with the merger of the European Economic Community, European Coal and Steel Community, and European Atomic Energy Community. , which collectively represents a $400 million diltiazem market. With licensing agreements now signed for the UK, Ireland, France, Spain, Germany and The Netherlands, we will continue to aggressively pursue agreements in other European countries." Mr. Melnyk concluded, "Our recent approval for Tiazac in five dosage dosage /dos·age/ (do´saj) the determination and regulation of the size, frequency, and number of doses. dos·age n. 1. Administration of a therapeutic agent in prescribed amounts. strengths (120mg, 180mg, 240mg, 300mg and 360mg) by the Health Protection Branch in Canada marks the beginning of a very focused marketing and sales campaign Noun 1. sales campaign - an advertising campaign intended to promote sales ad blitz, ad campaign, advertising campaign - an organized program of advertisements sales campaign n → campaña de venta aimed directly at physicians by our newly-created, wholly-owned subsidiary, Crystaal Corporation, known previously as Biovail Pharma. Crystaal will generate initial revenues in the second quarter of 1997. In addition, Crystaal will also market Biovail's existing controlled release product portfolio, as well as select in-licensed branded products, throughout Canada. For example, Crystaal has reached an agreement with Forest Laboratories Inc. to in-license Flumadine, an anti-viral drug used for the treatment of influenza A influenza A n. Influenza caused by infection with a strain of influenza virus type A. influenza A Infectious disease An avian virus, especially of ducks–which in China live near the pig reservoir and 'vector'; ." 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. -0-
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,
1997 1996
REVENUE
Contract $ 740 $ 1,157
Manufacturing 13,290 12,771
Royalty and licensing 2,362 2,346
16,392 16,274
EXPENSES
Cost of contract revenue 484 929
Cost of manufactured goods sold 4,323 5,464
Research and product development 3,065 2,039
Selling, general and administrative 2,647 2,943
10,519 11,375
OPERATING INCOME 5,873 4,899
INTEREST INCOME (EXPENSE), net (15) 170
INCOME BEFORE INCOME TAXES 5,858 5,069
PROVISION FOR INCOME TAXES 308 382
NET INCOME $ 5,550 $ 4,687
EARNINGS PER SHARE $ 0.22 $ 0.18
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 25,430,000 25,343,000
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(All dollar amounts are expressed in thousands of U.S. dollars)
March 31, December 31,
1997 1996
ASSETS (Unaudited)
Current
Cash and short-term deposits $ 6,710 $ 4,256
Accounts receivable 12,839 10,364
Inventories 9,670 8,134
Executive stock purchase plan loans 2,541 2,512
Deposits and prepaid expenses 1,294 1,063
33,054 26,599
Fixed Assets 24,838 24,819
Other Assets 7,051 7,188
$ 64,943 $ 58,606
LIABILITIES
Current
Bank indebtness $ 3,717 $ -
Accounts payable 5,824 5,468
Accrued liabilities 1,882 1,738
Income taxes payable 989 808
Customer prepayments 4,151 6,681
Current portion of long-term debt 1,950 2,298
18,513 16,993
Long-Term Debt 4,010 4,670
22,523 21,663
SHAREHOLDERS' EQUITY
Share capital 14,505 14,614
Retained earnings 28,262 22,712
Cumulative translation account (347) (383)
42,420 36,943
$ 64,943 $ 58,606
CONTACT: Biovail Corporation International Eugene Melnyk Chairman of the Board Bob Podruzny Chief Financial Officer (416) 285-6000 or Morgen-Walke Associates Investor Relations Investor relations The process by which the corporation communicates with its investors. : Donna Stein/ Dan Durkin/Cindy Hintelmann Press: Stacy Berns (212) 850-5600 |
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