Biovail Reports Record Financial Results -- Announces ANDA Generic Filing for Dilacor XR.TORONTO--(BW HealthWire)--Oct. 29, 1998--Biovail Corporation International (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency ) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) today reported record third quarter and nine month financial results for the period ended Sept. 30, 1998. The company also reported it had filed in the third quarter 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 a generic version of Dilacor Di·la·cor A trademark for the drug diltiazem hydrochloride. XR, a once daily formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of 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. which has U.S. sales in excess of $148 million. Biovail's revenues for the third quarter of 1998 were $29.0 million representing an increase of 37% over 1997 third quarter revenues of $21.2 million. Net income for the third quarter of 1998 increased 40% to $13.2 million, or $0.49 per share, compared to net income of $9.4 million, or $0.37 per share, in the third quarter of 1997. Revenues for the nine months ended Sept. 30, 1998 of $76.1 million were 36% higher than the revenues of $56.1 million for the comparable 1997 period. Net income for the nine months ended Sept. 30, 1998 increased by 39% to $30.6 million, or $1.14 per share, compared to $22.0 million, or $0.87 per share for the nine months ended Sept. 30, 1997. "We are extremely pleased with the Company's strong performance," commented 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 of the Board. "We have just completed a very successful quarter in which our base business achieved significant growth and our scientific objectives were met with the ANDA filing for a generic version of Dilacor XR. Dilacor XR is our third ANDA filing this year and is our seventh ANDA filing in less than thirty months." "In Canada Canada (kăn`ədə), independent nation (2001 pop. 30,007,094), 3,851,787 sq mi (9,976,128 sq km), N North America. Canada occupies all of North America N of the United States (and E of Alaska) except for Greenland and the French islands of , Tiazac Tiazac® Diltiazem, see there (R) received marketing approval for the angina Angina Definition Angina is pain, "discomfort," or pressure localized in the chest that is caused by an insufficient supply of blood (ischemia) to the heart muscle. indication; we filed controlled-release generic applications for Cardizen SR, Trental Tren·tal A trademark for the drug pentoxifylline. pentoxifylline Apo-Pentoxyphylline (CA), Neotren (UK), Nu-Pentoxyphylline SR (CA), Pentoxil, Trental Pharmacologic class: , and Verelan Verelan® Verapamil, see there ; and we successfully acquired exclusive Canadian Canadian (kənā`dēən), river, 906 mi (1,458 km) long, rising in NE New Mexico. and flowing E across N Texas and central Oklahoma into the Arkansas River in E Oklahoma. marketing rights for Retavase(TM) from Centocor Centocor is a biotechnology company that was founded in Philadelphia in 1979 with an initial goal of developing new diagnostic assays using monoclonal antibody technology. , Inc. Biovail continues to perform as expected in meeting the Company's stated objectives," concluded 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. "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 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 TPD TPD Tons Per Day TPD Therapeutic Products Directorate TPD Total and Permanent Disablement (insurance) TPD Temperature Programmed Desorption TPD Temporary Partial Disability (insurance) 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 - -0-
BIOVAIL CORPORATION INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
(All dollar amounts are expressed in thousands of U.S. dollars)
Sept. 30, Dec. 31,
1998 1997
___________ ___________
(Unaudited)
ASSETS
Current
Cash and short-term deposits $ 11,892 $ 8,275
Short-term investment 2,500 -
Accounts receivable 36,481 33,114
Inventories 17,955 16,609
Executive loans 2,868 2,933
Deposits and prepaids 2,575 2,053
___________ ___________
74,271 62,984
Long-term investments 7,500 -
Fixed Assets, net 23,429 24,172
Other Assets, net 24,376 6,583
___________ ___________
$ 129,576 $ 93,739
___________ ___________
___________ ___________
LIABILITIES
Current
Bank Indebtedness $ 10,051 $ -
Accounts payable 6,859 4,579
Accrued liabilities 4,851 6,002
Income taxes payable 1,899 1,013
Customer prepayments 4,836 1,840
Current portion of long-term debt 1,124 1,887
___________ ___________
29,620 15,321
Long-Term Debt 14,148 2,960
___________ ___________
43,768 18,281
___________ ___________
Shareholders' Equity
Share capital 20,683 18,465
Warrants 8,244 8,244
Retained earnings 58,267 49,709
Cumulative translation adjustment (1,386) (960)
___________ ___________
85,808 75,458
___________ ___________
$ 129,576 $ 93,739
___________ ___________
___________ ___________
-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 Nine Months Ended
Sept. 30, Sept. 30,
1998 1997 1998 1997
__________ __________ __________ __________
REVENUE
Research and
development $ 8,974 $ 4,887 $ 20,927 $ 7,046
Manufacturing 16,540 10,367 45,303 38,904
Royalty and
licensing 3,476 5,978 9,905 10,124
__________ __________ __________ __________
28,990 21,232 76,135 56,074
__________ __________ __________ __________
EXPENSES
Research and
development 4,047 4,893 12,179 11,452
Cost of manufactured
goods sold 6,946 2,947 18,956 11,128
Selling, general and
administrative 4,067 3,350 12,521 10,075
__________ __________ __________ __________
15,060 11,190 43,656 32,655
__________ __________ __________ __________
OPERATING INCOME 13,930 10,042 32,479 23,419
INTEREST EXPENSE,
net (97) (142) (254) (208)
__________ __________ __________ __________
INCOME BEFORE
INCOME TAXES 13,833 9,900 32,225 23,211
PROVISION FOR INCOME
TAXES 629 491 1,629 1,174
__________ __________ __________ __________
NET INCOME $ 13,204 $ 9,409 $ 30,596 $ 22,037
__________ __________ __________ __________
__________ __________ __________ __________
EARNINGS PER SHARE $ 0.49 $ 0.37 $ 1.14 $ 0.87
__________ __________ __________ __________
__________ __________ __________ __________
WEIGHTED AVERAGE
NUMBER OF COMMON
SHARES OUTSTANDING 26,899,290 25,447,000 26,899,290 25,447,000
__________ __________ __________ __________
__________ __________ __________ __________
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