Biovail Announces Record 2000 Fourth Quarter and Year End Financial Results; Revenue and Diluted Earnings per Share Increase 79% and 67% Respectively.Business Editors, Health/Medical Writers TORONTO--(BW HealthWire)--Feb. 28, 2001 Biovail Biovail TSX: BVF NYSE: BVF is Canada's largest pharmaceutical company, operating internationally in all aspects of pharmaceutical products. Its major production facility is located in Steinbach, Manitoba. Provides Revenue and Earnings Guidance for 2001 and 2002 Biovail Corporation (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.) announced today that net earnings totaled $40.4 million for the fourth quarter ended December December: see month. 31, 2000, an increase of 128% from $17.7 million for the fourth quarter of 1999, excluding certain charges discussed below. For the year ended December 31, 2000, net earnings equaled $114.7 million reflecting an increase of 120% over net earnings of $52.2 million for the same prior year period, excluding certain charges. Diluted earnings per share diluted earnings per share An earnings measure calculated by dividing net income less preferred stock dividends for a period by the average number of shares of common stock that would be outstanding if all convertible securities were converted into shares of increased 100% from $0.14 to $0.28 for the fourth quarter of 2000, excluding certain charges. Diluted earnings per share of $0.80 for the year ended December 31, 2000 increased by 67% from the 1999 year end level of $0.48, excluding certain charges. The charges excluded above include charges for acquired research and development in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with U.S. Generally Accepted Accounting Principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting (GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). ), the impact of Staff Accounting Bulletin (SAB SAB Spontaneous abortion. See Abortion. ) 101, an extraordinary item related to the early retirement of Senior Notes, the 1999 equity loss in Fuisz Technologies Ltd. (Fuisz) and a gain on the disposal of long-term Long-term Three or more years. In the context of accounting, more than 1 year. long-term 1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term. investments in 1999. Unless otherwise noted, all financial results reported reflect the application of the recently adopted SAB 101 related to certain revenue recognition principles. SAB 101 requires certain initial up-front up-front or up·front Informal adj. 1. Straightforward; frank. 2. Paid or due in advance: up-front cash. adv. or milestone “Milemarker” redirects here. For the American indie rock band, see Milemarker (band). A milestone or kilometre sign is one of a series of numbered markers placed along a road at regular intervals, typically at the side of the road or in a median. fees to be deferred and amortized over future periods. As a result of SAB 101, certain initial fees recognized in prior periods have been deferred and are being amortized over the terms of the relevant agreements. For the year 2000, Biovail recorded a charge on its financial statements under the line "Cumulative effect of change in accounting principle" of $43.5 million for the SAB 101 impact related to income recognized in prior years. Revenues increased 54% to $99.8 million for the fourth quarter 2000 compared to $64.8 million for the fourth quarter 1999. For the year ended December 31, 2000, revenues increased $136.7 million or 79% to $309.2 million versus revenues of $172.5 million for the year ended December 31, 1999. Product sales revenue increased by 172% to $90.4 million for the fourth quarter 2000 versus the 1999 fourth quarter, primarily driven by the product launches of generic versions of Adalat Ad·a·lat A trademark for the drug nifedipine. CC, Procardia Pro·car·di·a A trademark for the drug nifedipine. nifedipine Adalat CC, Adalat PA (CA), Adalat XL (CA), Adipine (UK), Afeditab CR, Angiopine (UK), Apo-Nifed (CA), Calchan (UK), Cardilate MR (UK), Cordacten (UK), XL and Voltaren Vol·ta·ren A trademark for the drug diclofenac potassium. diclofenac sodium Voltaren, Voltaren XR Pharmacologic class: Cyclooxygenase inhibitor, nonsteroidal anti-inflammatory drug (NSAID) XR as well as the inclusion of branded pharmaceutical product sales from newly acquired Biovail Pharmaceuticals (formerly DJ Pharma Pharma may be an abbreviation for:
cephalexin, Keflex, Keflin , Cedax Ce·dax A trademark for the drug ceftibuten. ceftibuten Cedax Pharmacologic class: Third-generation cephalosporin Therapeutic class: Anti-infective , Rondec and Dura-Vent and a higher level of sales of the Tiazac Tiazac® Diltiazem, see there (R) brand reflecting further market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" for this well established franchise. The factors highlighted above, as well as significant growth for the Crystaal portfolio of products, and the launch of Biovail's first Flash Dose(R) product, Nurofen Nurofen is the brand name of a range of pain-relief medication made by Boots Healthcare, recently acquired by UK drug company Reckitt Benckiser. There are eleven variants of Nurofen which all contain the analgesic ibuprofen, which was developed by the research arm of Boots, Meltlets, contributed to the 126% increase in full year 2000 product sales revenue of $225.0 million versus 1999 product sales revenue levels of $99.5 million. Research and development revenues were $4.1 million and $66.8 million for the three months and twelve months ended December 31, 2000, respectively, versus $23.0 million and $48.2 million for the three months and twelve months ended December 31, 1999, respectively. The reduction in fourth quarter 2000 versus fourth quarter 1999 research and development revenues was due to the termination of Biovail's research and development arrangement with Intelligent Polymers Limited (IPL (Initial Program Load) Same as boot. 1. IPL - Information Processing Language. 2. IPL - Internet Public Library. 3. IPL - Initial Program Load. 4. IPL - Initial Program Loader. ) at the end of September September: see month. 2000. Prior to September 30, 2000, Biovail had been receiving revenue from IPL for the development of several branded products. Biovail received no revenue from IPL after September 30, 2000 as IPL incurred the research and development expenditures directly. The year over year increase was primarily due to increased research and development activity associated with branded products and the related revenue received from IPL for the first nine months of 2000. Royalty and licensing revenue was $5.3 million and $17.3 million for the fourth quarter and year ended December 31, 2000, respectively, versus $8.6 million and $24.7 million for the fourth quarter and year ended December 31, 1999. The decrease in royalty and licensing revenue in 2000 versus 1999 reflects a lower level of licensing activity during 2000. Gross margins improved from 1999 levels of 65% to 70% for the year 2000 due to higher margins associated with the sale of certain generic products, Crystaal brands and the higher margins associated with the newly acquired Biovail Pharmaceutical brands. Research and development expenses increased 59% over 1999 levels and were $52.7 million for the year ended December 31, 2000. This increase in annual research and development expenditures was due to increased activity related to developmental programs associated with Biovail's branded product pipeline and the Company's Flash Dose(R) developmental product pipeline. The decline in fourth quarter expenses was due to IPL incurring in·cur tr.v. in·curred, in·cur·ring, in·curs 1. To acquire or come into (something usually undesirable); sustain: incurred substantial losses during the stock market crash. 2. related research and development expenditures directly. Selling, general and administrative expenditures increased 50% to $58.1 million reflecting incremental Additional or increased growth, bulk, quantity, number, or value; enlarged. Incremental cost is additional or increased cost of an item or service apart from its actual cost. expenses associated with the acquisition of Biovail Technologies (formerly Fuisz Technologies), the acquisition of Biovail Pharmaceuticals and amortization related to these acquisitions. Fourth quarter 1999 expenses included a non-cash compensation expense charge related to stock options due to a change to U.S. GAAP while fourth quarter 2000 included a higher level of operational expenses related to the selling and marketing of pharmaceutical products by Biovail Pharmaceuticals and the Crystaal division and acquisition and related amortization expenses associated with the acquisition of Biovail Technologies and Biovail Pharmaceuticals. In accordance with U.S. GAAP, Biovail took charges related to acquired research and development totaling $66.9 million during the fourth quarter 2000 and $208.4 million for the full year 2000 related to the completion of the acquisition of IPL. Including charges, Biovail reported a net loss and diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. loss per share of $22.7 million and $0.18, respectively for the fourth quarter 2000, and a net loss and diluted loss per share of $148.0 million and $1.16, respectively for the year ended December 31, 2000. Operating cash flow Operating cash flow Earnings before depreciation minus taxes. Measures the cash generated from operations, not counting capital spending or working capital requirements. for 2000 was in excess of $100 million, approximately ap·prox·i·mate adj. 1. Almost exact or correct: the approximate time of the accident. 2. a 100% increase over 1999. Biovail currently forecasts the following quarterly ranges for 2001 and 2002 for revenue and diluted earnings per share excluding charges:
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Range of First Quarter Second Third Quarter Fourth
Results Ending Quarter Ending Quarter
3/31/01 Ending 9/30/01 Ending
6/30/01 12/31/01
----------------------------------------------------------------------
Total Revenues
($USMillions) $110 - $120 $125 - $140 $135 - $150 $150 - $170
Diluted EPS $0.15 - $0.20 $0.25 - $0.30 $0.30 - $0.40 $0.40 - $0.50
----------------------------------------------------------------------
----------------------------------------------------------------------
Range of
Results 2001 2002
----------------------------------------------------------------------
Total Revenues
($USMillions) $540 - $570 $685 - $720
Diluted EPS $1.23 - $1.30 $1.60 - $1.75
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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, commented, "The financial accomplishments achieved during 2000 coupled with Biovail's acquisition of a first rate U.S. sales and marketing organization and its acquisition of the 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, franchise positions Biovail very favourably Adv. 1. favourably - showing approval; "he reviewed the play favorably" favorably favourably U.S. favorably adverb 1. for its on-going Adj. 1. on-going - currently happening; "an ongoing economic crisis" ongoing current - occurring in or belonging to the present time; "current events"; "the current topic"; "current negotiations"; "current psychoanalytic theories"; "the ship's current position" transition towards a more fully integrated pharmaceutical company." Separately, Biovail announced the appointment of William S William, crown prince of Germany William or Frederick William, 1882–1951, crown prince of Germany, son of William II. In World War I he commanded (1914) an army on the Western Front and was nominal commander in the German attack . Poole Poole, town (1991 pop. 122,815), Dorset, S England, on the north side of Poole Harbour. Poole has shipbuilding, pottery-making, and other industries. It is a naval supply station and a seaplane base with considerable coastal trade. There is also a technical college. as President, Biovail Corporation - Pharmaceuticals. Mr. Poole joins Biovail from Novo Nordisk Wikipedia is not the place for advertisement or self-advertising. Novo Nordisk (, NYSE: NVO) manufactures and markets pharmaceutical products and services. Founded in Denmark in 1923, the company has since become a world leader in diabetes care with the broadest Pharmaceutical Inc. and will assume responsibility for all executive functions Executive functions is a term synonymous with cognitive control, and used by psychologists and neuroscientists to describe a loosely defined collection of brain processes whose role is to guide thought and behaviour in accordance with internally generated goals or plans. relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc Biovail's sales and marketing organizations, business development, the Contract Research division and manufacturing. Robert Robert, Henry Martyn 1837-1923. American army engineer and parliamentary authority. He designed the defenses for Washington, D.C., during the Civil War and later wrote Robert's Rules of Order (1876). Noun 1. Podruzny will continue to contribute to Biovail's future growth as Senior Vice President - Strategic Development and will work closely with and report to the Chairman. The Company's regularly scheduled quarterly conference call will be broadcast live at 8:30 a.m. EST EST electroshock therapy. EST abbr. electroshock therapy on the World Wide Web at www.biovail.com and a replay of the conference call will be available on this website shortly after the call. Biovail Corporation is an international full-service full-ser·vice adj. Associated with or offering complete service: full-service gasoline pumps; full-service banks. pharmaceutical company, engaged in the formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation , clinical testing, registration, manufacture, sale and promotion of pharmaceutical 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. 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 reg·u·late tr.v. reg·u·lat·ed, reg·u·lat·ing, reg·u·lates 1. To control or direct according to rule, principle, or law. 2. environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
BIOVAIL CORPORATION
CONSOLIDATED BALANCE SHEETS
IN ACCORDANCE WITH U.S. GAAP
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)
As at December 31,
-----------------------------
2000 1999
----------- -----------
ASSETS
Current
Cash and cash equivalents $ 125,144 $ 178,086
Restricted cash -- 11,258
Short-term investments -- 54,635
Accounts receivable 105,850 60,571
Inventories 24,108 12,701
Assets held for disposal -- 20,000
Deposits and prepaid expenses 5,347 3,172
----------- -----------
Total current assets 260,449 340,423
Long-term investments 1,561 12
Property, plant and equipment, net 52,541 45,300
Goodwill, net 103,105 31,771
Intangible assets, net 667,431 45,454
Other assets, net 22,180 4,219
----------- -----------
Total assets $ 1,107,267 $ 467,179
=========== ===========
LIABILITIES
Current
Accounts payable $ 34,683 $ 22,685
Accrued liabilities 35,452 31,107
Income taxes payable 6,711 3,585
Deferred revenue 54,234 4,962
Current portion of
long-term obligations 182,564 12,016
----------- -----------
Total current liabilities 313,644 74,355
Long-term obligations 256,180 125,488
Convertible Subordinated
Preferred Equivalent Debentures 299,985 --
----------- -----------
Total liabilities 869,809 199,843
----------- -----------
SHAREHOLDERS' EQUITY
Common shares 492,733 373,962
Warrants 7,912 8,244
Warrant subscription receivable -- (2,287)
Deficit (261,819) (113,843)
Accumulated other comprehensive
income (loss) (1,368) 1,260
----------- -----------
Total shareholders' equity 237,458 267,336
----------- -----------
Total liabilities and
shareholders' equity $ 1,107,267 $ 467,179
=========== ===========
BIOVAIL CORPORATION
CONSOLIDATED STATEMENTS OF LOSS
IN ACCORDANCE WITH U.S. GAAP
(All dollar amounts except per share data are expressed in thousands
of U.S. dollars)
(Unaudited)
Three Months Ended Year Ended
December 31, December 31,
-------------------------- -------------------------
2000 1999 2000 1999
------------ ------------ ------------ ------------
Revenue
Product sales $ 90,441 $ 33,255 $ 224,996 $ 99,526
Research and
development 4,104 23,023 66,834 48,232
Royalty and
licensing 5,264 8,567 17,340 24,706
------------ ------------ ------------ ------------
99,809 64,845 309,170 172,464
------------ ------------ ------------ ------------
Expenses
Cost of
goods sold 26,660 13,245 68,031 35,078
Research and
development 4,238 13,648 52,659 33,130
Selling,
general and
administrative 17,845 17,423 58,088 38,727
Acquired
research and
development 66,924 105,689 208,424 105,689
------------ ------------ ------------ ------------
115,667 150,005 387,202 212,624
------------ ------------ ------------ ------------
Operating loss (15,858) (85,160) (78,032) (40,160)
Equity loss -- (1,257) -- (58,399)
Interest income
(expense), net (2,264) (981) 2,955 (9,152)
Gain on disposal
of long-term
investments,
net -- 1,948 -- 1,948
------------ ------------ ------------ ------------
Loss before
income taxes (18,122) (85,450) (75,077) (105,763)
Provision for
income taxes 4,625 1,845 9,360 4,215
------------ ------------ ------------ ------------
Loss before
extraordinary
item (22,747) (87,295) (84,437) (109,978)
Extraordinary
item - Premium
paid on early
extinguishment
of U.S. Dollar
Senior Notes -- -- (20,039) --
------------ ------------ ------------ ------------
Loss before
cumulative
effect of
change in
accounting
principle (22,747) (87,295) (104,476) (109,978)
Cumulative
effect of
change in
accounting
principle -- -- (43,500) --
------------ ------------ ------------ ------------
Net loss $ (22,747) $ (87,295) $ (147,976)$ (109,978)
============ ============ ============ ============
Basic and
diluted loss
per share
Loss before
extraordinary
item and
change in
accounting
principle $ (0.18) $ (0.75) $ (0.66)$ (1.07)
Extraordinary
item -- -- (0.16) --
Change in
accounting
principle -- -- (0.34) --
------------ ------------ ------------ ------------
Net loss $ (0.18) $ (0.75) $ (1.16)$ (1.07)
============ ============ ============ ============
Weighted average
number of
common shares
outstanding
Basic 129,980,000 116,812,000 128,824,000 102,542,000
============ ============ ============ ============
Diluted 146,477,000 122,444,000 143,512,000 108,174,000
============ ============ ============ ============
BIOVAIL CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
IN ACCORDANCE WITH U.S. GAAP
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)
Year Ended
December 31,
-------------------------
2000 1999
--------- ---------
Cash flows from operating activities
Net loss $(147,976) $(109,978)
Depreciation and amortization 21,526 8,885
Acquired research and development 208,424 80,689
Extraordinary item 20,039 --
Compensation cost for employee
stock options 461 7,641
Equity loss -- 58,399
Gain on disposal of long-term
investments, net -- (1,948)
--------- ---------
102,474 43,688
Change in non-cash operating items 20 8,297
--------- ---------
Cash provided by operating activities 102,494 51,985
--------- ---------
Cash flows from investing activities
Additions to property, plant and
equipment, net (15,845) (7,759)
Acquisition of businesses, net of
cash acquired (622,145) (43,720)
Maturity of (additions to)
short-term investments, net 65,893 (54,665)
Acquisition of product rights (27,753) (13,340)
Disposal (acquisition) of long-term
investments, net (2,453) 11,991
Proceeds from assets held for
disposal 20,000 --
Repayment of executive stock
purchase plan loans -- 3,100
--------- ---------
Cash used in investing activities (582,303) (104,393)
--------- ---------
Cash flows from financing activities
Issuance of common shares 109,603 253,721
Repurchase of common shares -- (30,593)
Proceeds from exercise of warrants 6,010 --
Issuance of Convertible Subordinated
Preferred Equivalent
Debentures, net of financing costs 288,772 --
Advances under revolving term credit
facility, net of financing costs 207,000 --
Repurchase of U.S. Dollar Senior
Notes (141,017) --
Reduction in long-term obligations (45,601) (75,212)
Collection of warrant subscription
receivable 2,287 4,028
--------- ---------
Cash provided by financing activities 427,054 151,944
--------- ---------
Effect of exchange rate changes on
cash and cash equivalents (187) 271
--------- ---------
Increase (decrease) in cash and cash
equivalents (52,942) 99,807
Cash and cash equivalents, beginning
of year 178,086 78,279
--------- ---------
Cash and cash equivalents, end of
year $ 125,144 $ 178,086
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