Biovail Reports 2003 Fourth Quarter and Full Year Financial Results.Business Editors/Health/Medical Writers TORONTO--(BUSINESS WIRE)--March 3, 2004 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 ) (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :BVF): -- Core Product sales revenue increases by 59% -- Core Product Revenue $172 million for 2003 versus $108 million for 2002 -- Biovail Pharmaceuticals Canada Product Revenue $85 million for 2003 versus $33 million for 2002 -- Wellbutrin Well·bu·trin A trademark for the drug bupropion hydrochloride, used to treat depression. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban XL Revenue $65 million for 2003 -- Legacy Product Revenue $209 million for 2003 versus $324 million for 2002 -- Generic Product Revenue $101 million for 2003 versus $182 million for 2002 -- Slides to facilitate the earnings call may be accessed at www.biovail.com Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today its financial results for the three and twelve month periods ending December 31, 2003. Total revenues for the three months ended December 31, 2003 were $199.7 million versus $238.7 million for the three months ended December 31, 2002. Total revenues for the twelve months ended December 31, 2003 were $823.7 million representing an increase of 5% versus $788.0 million for the prior year. Total revenues for fourth quarter 2003 were favourably impacted versus fourth quarter 2002 total revenues by the launches of 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, LA, Teveten Tev·e·ten A trademark for the drug eprosartan mesylate. eprosartan mesylate Teveten Pharmacologic class: Angiotensin II receptor antagonist Therapeutic class: HCT Hct abbr. hematocrit HCT Hematocrit, see there , Zovirax Zo·vi·rax A trademark for the drug acyclovir. acyclovir sodium Alti-Acyclovir (CA), Avirax (CA), Zovirax Pharmacologic class: Acyclic purine nucleoside analogue Therapeutic class: Cream and Wellbutrin XL in 2003, as well as an increase in products sales by the Company's 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. division due to the acquisition of Wellbutrin SR and Zyban Zy·ban A trademark for the drug bupropion dipropionate, used to treat nicotine dependence. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban . Fourth quarter 2003 total revenue versus fourth quarter 2002 total revenues were offset by lower revenue of the Company's Zovirax, Legacy and Generic product lines, as well as lower research and development revenue and co-promotion, royalty and licensing revenue. Full year 2003 total revenues versus 2002 total revenues were favourably impacted by the product launches described above and the Company's Canadian division, as well as by higher royalty revenue related to an interest in the gross margins of a generic omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with product. This increase in 2003 total revenue was partially offset by lower product sales revenue of the Company's Legacy and Generic product lines. 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 and Chief Executive Officer commented, "2003 was a year of transition for Biovail as we made significant progress towards a fully-integrated pharmaceutical company and started to invest strategically for 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. growth in our operations, sales and marketing areas. First half 2004 will be a period of investment as we continue to expand and specialize spe·cial·ize v. 1. To limit one's profession to a particular specialty or subject area for study, research, or treatment. 2. To adapt to a particular function or environment. our sales force in the U.S. and capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. our products and pipeline by balancing conservative returns on investment with necessary investments for growth. 2005 will be a year of superior financial results whereby the benefits of 2004 strategic investing is expected to deliver on long-term objectives for growth and profitability. These results will be seen in new product launches, increased sales throughout the U.S. and simultaneously developing our rapidly maturing pipeline of high value products." 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. GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). , fourth quarter 2003 net loss of $96.0 million 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 $0.60 compared to fourth quarter 2002 net loss of $102.8 million and diluted loss per share of $0.65. In accordance with U.S. GAAP, the twelve-month period ended December 31, 2003 net loss was $27.3 million and diluted loss per share was $0.17 compared to net income of $87.8 million and earnings per share of $0.55 for the twelve-month period ended December 31, 2002. The Company had diluted shares outstanding of 159.3 million and 159.9 million for fourth quarter and full year 2003 respectively compared to 158.1 million and 160.5 million for the fourth quarter and full year 2002 respectively. In the fourth quarter of 2003, Biovail reduced its provision for tax contingencies Contingencies (ISSN 1048-9851) is the bimonthly magazine of the American Academy of Actuaries, providing a large and diverse readership with general interest and technical articles on a wide range of issues related to the actuarial profession. by $12.0 million that were no longer required due to the resolution of tax uncertainties and 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. tax loses in the U.S. 2003 Financial Performance Biovail uses five categories to describe its product sales revenue thereby providing financial clarity and ease in monitoring Biovail's performance. These categories are as follows:
Core Products -- includes Cardizem LA, Zovirax products and
Teveten products
Wellbutrin XL -- identified as a separate line for ease in
tracking
Biovail Pharmaceuticals Canada (BPC) -- including Tiazac,
Wellbutrin SR and Zyban
Legacy Products -- includes Tiazac (brand and generic), Cardizem
CD (brand) Ativan/Isordil, Vasotec/Vaseretic, Rondec and Cedax
Generics -- controlled-release generics distributed by Teva
Pharmaceuticals
Product Sales Performance Product sales revenue for the fourth quarter 2003 were $168.3 million compared to $183.8 million in the fourth quarter of 2002, reflecting a decrease of 8%. Product sales revenue were $632.9 million for the year 2003 compared to $646.0 million for the year 2002, reflecting a decrease of 2%. Fourth quarter 2003 product sales revenue was decreased by a $20.0 million increase in the provision for returns. The increase in the provision for returns is due to greater physician acceptance of the benefits of Cardizem LA versus Cardizem CD and an anticipation of greater conversion by Cardizem LA of Cardizem CD. Core Product sales revenue for the fourth quarter was $33.8 million compared to $34.1 million in the fourth quarter of 2002, a decrease of 1%. The Core Product sales revenue for year 2003 was $172.4 million compared to $108.3 million for year 2002 reflecting an increase of 59%. The Core Product sales revenue reflects the launches of Cardizem LA, Teveten HCT and Zovirax Cream during 2003. Cardizem LA is performing well and is now capturing 10% of new prescriptions written for once-daily diltiazems. Teveten total prescriptions increased 110% in 2003 versus 2002 and Zovirax is capturing 65% share of the topical topical /top·i·cal/ (top´i-k'l) pertaining to a particular area, as a topical antiinfective applied to a certain area of the skin and affecting only the area to which it is applied. top·i·cal adj. anti-viral market. Wellbutrin XL product sales revenue was $48.6 million for fourth quarter 2003 and $64.9 million for the year 2003. Fourth quarter 2003 Wellbutrin XL sales included the recovery of over 90% of Wellbutrin XL product that was involved in a traffic accident on October 1, 2003. As part of a comprehensive earnings guidance press release on October 3, 2003, Biovail announced that its estimated revenue from Wellbutrin XL for third quarter 2003 would be less than $10.0 million partially as a result of the truck accident and that the loss in revenue due to the accident would be in the range of $10.0 million to $20.0 million. Numerous variables that were not known and were unavailable on October 3, 2003 are now determinable Liable to come to an end upon the happening of a certain contingency. Susceptible of being determined, found out, definitely decided upon, or settled. determinable adj. given better information and the reconciliation provided by GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) to Biovail. Variables that determine Biovail's revenue that were not then known include levels of discounts, free goods goods admitted into a country free of duty. - W. Black. See also: Free or rebates that would have been deducted de·duct v. de·duct·ed, de·duct·ing, de·ducts v.tr. 1. To take away (a quantity) from another; subtract. 2. To derive by deduction; deduce. v.intr. from GSK's gross sales Gross Sales A measure of overall sales that isn't adjusted for customer discounts or returns, calculated simply by adding all sales invoices, and not including operating expenses, cost of goods sold, payment of taxes, or any other charge. and the percentage of GSK's net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight Biovail is to receive. In calculating the high end of the estimate range, Biovail also took into consideration the variables that analysts were generally using in their models to estimate the Wellbutrin XL revenues, which included typically higher pricing, higher percentage supply prices and did not reflect the typical gross to net deductions. This analysis with analyst estimates was completed to better explain why revenue in third quarter 2003 would be less than previously expected by analysts. After a subsequent review of all of the facts, the actual revenue loss from the accident was determined to be $5.0 million. Calculated with analysts' assumptions for these variables, the revenue loss estimate would range from $7.5 million to $8.0 million. Product sales revenue by BPC BPC British Potato Council BPC Brewton-Parker College (Mt Vernon, GA) BPC Bible Presbyterian Church BPC Bangladesh Petroleum Corporation (Chittagong, Bangladesh) BPC British Pharmaceutical Codex was $23.4 million for the fourth quarter in 2003 compared to $9.7 million in the fourth quarter of 2002, an increase of 141%. The product sales were $85.2 million for the year 2003 compared to $32.6 million for year 2002 an increase of 161%. The primary growth drivers are Tiazac Tiazac® Diltiazem, see there as well as revenues from Wellbutrin SR and Zyban, which were acquired at the end of 2002. Product sales revenue from Legacy Products was $36.4 million for the fourth quarter in 2003 compared to $87.5 million in the fourth quarter of 2002. These product sales were $208.9 million for the year 2003 compared to $323.6 million for year 2002. The lower level of Legacy Products revenue reflects the expected decline in these older, genericized products. Product sales revenue from controlled-release generics was $25.9 million for the fourth quarter in 2003 compared to $52.5 million in the fourth quarter of 2002. These product sales were $101.5 million for the year 2003 compared to $181.5 million for year 2002. The decline in the generic product sales is in part due to lower volumes of Adalat Ad·a·lat A trademark for the drug nifedipine. CC sold following the generic entry of Watson Pharmaceuticals Watson Pharmaceuticals, Incorporated (NYSE: WPI) is the 5th largest pharmaceutical company in the United States based on number of prescriptions dispensed. Based in Corona, California, Watson's Generics division markets over 150 pharmaceutical product families, including one of the Inc. into the market. Sales of generic products for year 2003 were favourably impacted by an $8.5 million credit received from Teva in the third quarter for 2003, related to certain deductions it had taken in the calculation on net sales.
In summary:
--------------------------------- --------- ------------- ------------
($ Millions) 2003 Percent of Growth Rate
Sales total 2002
--------------------------------- --------- ------------- ------------
Core Products $172.4 27% 59%
Wellbutrin XL $64.9 10% N/A
BPC Products $85.2 14% 161%
Legacy Products $208.9 33% (35%)
Generics $101.5 16% (44%)
--------------------------------- --------- ------------- ------------
Total Product Sales $632.9 100% (2%)
--------------------------------- --------- ------------- ------------
Research and development (R&D) revenues were $3.4 million and $14.2 million for the three months and twelve months ended December 31, 2003 and compared to $9.3 million and $28.4 million for the comparable 2002 periods. The higher level of R&D revenues in 2002 is related to revenue received from GSK associated with the development of Wellbutrin XL. Co-promotion, royalty and licensing revenue was $28.0 million for fourth quarter 2003 and compared to $45.6 million for the comparable 2002 period. Co-promotion, royalty and licensing revenue of $176.6 million for the twelve months ended December 31, 2003 compared to $113.6 million for the 2002 comparable period. The increase in these revenues primarily relates to the Company's economic interest in the sales of a generic version of Prilosec Pri·lo·sec A trademark for the drug omeprazole. omeprazole Losec (CA) (UK), Heartburn Relief (UK), Prilosec, Prilosec OTC, Zegerid, Zanprol (UK) Pharmacologic class: Proton pump inhibitor . The Company earned $11.3 million and $103.0 million for the fourth quarter and full year 2003 respectively from this economic interest. Gross margins on total Product Sales were 70% and 78% for the three and twelve month periods ended December 31, 2003 versus 76% and 75% for the prior year comparable periods. Gross margins were favourably impacted by sales mix sales mix See product mix. of higher margin products such as Cardizem LA and Zovirax, offset by lower margins related to Wellbutrin XL revenue, which includes a mix of trade and samples. Research and development expenses increased by 107% and 66% to $26.1 million and $86.6 million for the three and twelve month periods ended December 31, 2003. The increase in research and development expenses is primarily due to numerous on-going developmental programs, Wellbutrin XL scale up activities and the Cardizem PLACE program. Selling, general and administrative expenses were $66.3 million for the fourth quarter 2003 versus $43.5 million for fourth quarter 2002, an increase of 52%. Selling, general and administrative expenses were $242.8 million for the twelve month period ended December 31, 2003 versus $166.4 million for the comparable 2002 period, an increase of 46%. The significant increase in selling, general and administrative expenses is due to a number of strategic decisions taken. The significant increase in selling, general and administrative expenses in 2003 are primarily related to our investment in our U.S. pharmaceutical business, both in terms of infrastructure restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). and costs associated with the launches of three products. Selling, general and administrative expenses for the fourth quarter and full year 2003 also included co-promotion fees payable to Reliant of $3.7 million and $20.9 million respectively. Amortization expense was $26.2 million and $140.9 million for the three and twelve month periods ending December 31, 2003 respectively versus $29.0 million and $71.5 million for the three and twelve month periods ending December 31, 2002. These increases primarily reflect the incremental amortization related to our economic interest in a generic version of Prilosec. Cash flow from operations Cash flow from operations A firm's net cash inflow resulting directly from its regular operations (disregarding extraordinary items such as the sale of fixed assets or transaction costs associated with issuing securities), calculated as the sum of net income plus noncash expenses decreased 16% at December 31, 2003 to $282.0 million versus $334.1 million at December 31, 2002. 2003 Significant Items Fourth quarter and twelve months ended December 31, 2003 U.S. GAAP financials were affected by several significant items. These 2003 significant items and their effect on U.S. GAAP earnings in the fourth quarter and full year 2003 are listed in the chart below:
Significant Items included in U.S. GAAP earnings
(All dollar amounts are expressed in million of U.S. dollars, except
per share data)
Three Months Ended December 31
----------------------------------------------------------------------
2003 2002
--------------- ---------------
Per Per
diluted diluted
Amount share Amount share
------ -------- ------ --------
Reorganization costs $4.4 $0.03 $- $-
Acquired research and development 22.1 0.14 167.7 1.06
Write-down of assets 45.1 0.28 30.6 0.19
Extinguishment of royalty obligation 61.3 0.38 - -
Reduction in effective tax rate (5.9) (0.04) - -
Release of tax reserve (12.0) (0.08) - -
Adjustment to product returns
provision 20.0 0.13 - -
Foreign exchange (gain) loss 4.4 0.03 (1.1) (0.01)
-------------------------------------- ------ -------- ------ --------
Twelve Months Ended December 31
----------------------------------------------------------------------
2003 2002
--------------- ---------------
Per Per
diluted diluted
Amount share Amount share
------ -------- ------ --------
Reorganization costs $7.5 $0.05 $- $-
Acquired research and development 124.7 0.78 167.7 1.05
Write-down of assets 45.1 0.28 30.6 0.19
Extinguishment of royalty obligation 61.3 0.38 - -
Release of tax reserve (12.0) (0.08) - -
Adjustment to product returns
provision 16.0 0.10 - -
Foreign exchange (gain) loss 14.0 0.09 (0.7) (0.00)
-------------------------------------- ------ -------- ------ --------
1. Reorganization Costs Selling, general and administrative expenses in the fourth quarter and twelve months of 2003 included $4.4 million and $7.5 million, respectively, of costs associated with the transition of U.S. commercial operations from Raleigh to Bridgewater. Those costs mainly comprised severance The act of dividing, or the state of being divided. The term severance has unique meanings in different branches of the law. Courts use the term in both civil and criminal litigation in two ways: first, when dividing a lawsuit into two or more parts, and second, when and retention bonuses payable to employees in Raleigh, as well as the cost to terminate the Raleigh lease. 2. Acquired research and development In the fourth quarter of 2003, we incurred a charge of $22.1 million for acquired research and development, which is comprised of: (i) $12.9 million related to the acquisition of tramadol tramadol /tra·ma·dol/ (tram´ah-dol?) an opioid analgesic used as the hydrochloride salt for the treatment of pain following surgical procedures and oral surgery. tramadol an opioid partial µ agonist. FT from Ethypharm S.A. ("Ethypharm"); and (ii) $11.1 million related to our increased interest in the BNC-PHARMAPASS products under development. In addition, we finalized See finalization. the allocation The apportionment or designation of an item for a specific purpose or to a particular place. In the law of trusts, the allocation of cash dividends earned by a stock that makes up the principal of a trust for a beneficiary usually means that the dividends will be treated as of the purchase price related to our second quarter of 2003 acquisition of Ativan At·i·van A trademark for the drug lorazepam. lorazepam Apo-Lorazepam (CA), Ativan, Novo-Lorazem (CA), Nu-Loraz (CA) Pharmacologic class: Benzodiazepine Therapeutic class: and Isordil, resulting in a reallocation Noun 1. reallocation - a share that has been allocated again allocation, allotment - a share set aside for a specific purpose 2. reallocation of $1.9 million from acquired research and development to intangible assets Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. In the twelve months of 2003, we incurred a charge of $124.7 million for acquired research and development, which is comprised of: (i) $44.2 million related to our acquisition of the Athpharma products; (ii) $38.1 million (as adjusted) related to our acquisition of the Ativan sublingual sublingual /sub·lin·gual/ (-ling´gwal) hypoglossal; beneath the tongue. sub·lin·gual adj. Abbr. SL Below or beneath the tongue; hypoglossal. products under development; (iii) $16.0 million related to our acquisition of tramadol FT from Ethypharm; and (iv) $26.4 million related to our interest in the BNC-PHARMAPASS products under development. Subsequent to year-end, Biovail acquired North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. rights to Ethypharm's Flashtab combination tramadol and acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. (Flashtab tamadol/acetaminophen) product, which complements Biovail's September 2003 purchase from Ethypharm of Flashtab tramadol and Biovail's once daily tramadol product. Concurrent with the negotiation for Flashtab tramadol/acetaminophen, Biovail has modified its shareholders Agreement with Ethypharm with respect to value protection of its 15% equity investment in Ethypharm from an indefinite INDEFINITE. That which is undefined; uncertain. INDEFINITE, NUMBER. A number which may be increased or diminished at pleasure. 2. When a corporation is composed of an indefinite number of persons, any number of them consisting of a majority of those period to an 18-month term. Biovail and Ethypharm have agreed to terminate the September 2003 Diltiazem CR License Agreement and Supply Agreement and terminated Biovial's obligation to provide convertible debenture Convertible Debenture Any type of debenture that can be converted into some other security. Notes: For example, a convertible bond can be converted into stock. financing to Ethypharm. The effect of these negotiations is a $12.9 million acquired research and development charge in fourth quarter, such that total charge for tramadol FT and the combination Flashtab tramadol/acetaminophen was $16.0 million in 2003. The value of Biovail's 15% investment in Ethypharm is currently enhanced by the equity protection the Company has negotiated. However, Ethypharm will need to achieve certain milestones within the 18-month term of equity protection in order for Biovail to realize its value or a write-down of this investment may become necessary. In July 2003, a joint venture was established between BLI BLI Buyers Laboratory Inc BLI BirdLife International BLI Budget Line Item BLI Blue Ling BLI Busy Lamp Indicator (VoIP) BLI Bellingham, WA, USA - Bellingham International (Airport Code) Pharmaceutical Developments Ltd (BNC (hardware) BNC - A connector for coaxial cable such as that used for some video connections and RG58 "cheapernet" connections. A BNC connector has a bayonet-type shell with two small knobs on the female connector which lock into spiral slots in the male connector when it is twisted ), a subsidiary of Biovail Laboratories Incorporated (49% ownership) and PharmaPass II, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control (51% ownership) for the purpose of developing enhanced or Super-Biovailable formulations of Coreg, Teveten and Flomax. The joint venture (BNC-PHARMAPASS, LLC) agreed to enter into an exclusive manufacturing and distribution agreement with Biovail of these products and BNC held an option to acquire PharmaPass II, LLC's interest in the joint venture. During third quarter and fourth quarter of 2003 research activities of the joint venture produced formulations for two products. During the fourth quarter PHARMAPASS II reduced its investment in BNC-PHARMAPASS, LLC it was entitled en·ti·tle tr.v. en·ti·tled, en·ti·tling, en·ti·tles 1. To give a name or title to. 2. To furnish with a right or claim to something: to following completion of certain development activities, which resulted in BNC's interest increasing to 84%, which resulted in an incremental $11.1 million charge to acquired research and development. Subsequent to year end Biovail exercised its option to purchase the remaining interest in BNC-PHARMAPASS, LLC for $5.0 million which will result in a charge in first quarter 2004 to acquired research and development. 3. Write-down of assets Due to the Company's transition plan for its U.S. pharmaceutical business, Biovail has identified certain non-core assets (approved pharmaceutical products) that do not fit with Biovail's therapeutically aligned promotional programs. Biovail focuses its therapeutically aligned sales efforts on cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. products including Cardizem LA, Teveten as well as Zovirax. Additionally, Biovail has to consider and plan for the launch of several pipeline products. With respect to products such as Rondec and Cedax, the Company is considering at several commercial options for these products including the initiation of negotiations for the potential sale of these products, Biovail recorded a $22.0 million non-cash charge Non-Cash Charge A charge off, made by a company against earnings, that does not require an initial outlay of cash. Notes: Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet. related to the write-down of the net book value of Cedax. In addition, we recorded a $21.4 million non-cash charge related to the write-down of the net book value of Rondec, based on the estimated fair value of this product at December 31, 2003. 4. Extinguishment The destruction or cancellation of a right, a power, a contract, or an estate. Extinguishment is sometimes confused with merger, though there is a clear distinction between them. of a royalty obligation In December 2003, we mutually agreed with Reliant to terminate Reliant's co-promotion of certain of our products effective December 31, 2003. We paid $61.3 million to extinguish Extinguish Retire or pay off debt. our trailing royalty obligation to Reliant. Reliant repaid $61.1 million of its $70.0 million loan payable to us, as well as $3.2 million of accrued interest Accrued Interest The interest that has accumulated on a bond since the last interest payment up to but not including the settlement date. There are two methods for calculating accrued interest: 1) 360-day year method, used for corporate and municipal bonds. on the loan. The remaining principal amount of $8.9 million was converted into 446,457 Series D Preferred Units of Reliant, which represents an ownership interest in Reliant of less than 2%. 5. Tax provision The effective tax rate for the year is 4% reflecting the losses arising in the U.S. from increased sales and marketing expenses. In the fourth quarter of 2003, we reduced the provision for tax contingencies by $12.0 million that were no longer required due to the resolution of tax uncertainties and incremental tax losses in the U.S. 6. Returns Provision During the fourth quarter 2003, Biovail increased its provision for returns by $20.0 million at December 31, 2003. The increase in the provision for returns is due to greater physician acceptance of the benefits of Cardizem LA versus Cardizem CD and an anticipation of greater conversion by Cardizem LA of Cardizem CD. 7. Foreign Exchange (gain) loss In preparation of its interim financial statements for each of the first three quarters of 2003, the Company translated the Canadian dollar Noun 1. Canadian dollar - the basic unit of money in Canada; "the Canadian dollar has the image of loon on one side of the coin" loonie dollar - the basic monetary unit in many countries; equal to 100 cents liability to GSK incurred in 2002 in regard to the purchase of Wellbutrin SR at the exchange rate existing as at the date of acquisition. However, in the course of preparing its financial statements for the fourth quarter and the full year 2003, the Company determined that U.S. GAAP requires that the Canadian dollar liability be translated at current rates. This translation results in changes to previously recognized foreign exchange (gains) losses of which $5.4 million, $3.9 million and ($3.1) million in the first, second and third quarters, respectively. The net income (loss) per share as adjusted is $0.36 for the first quarter, as compared with previously reported $0.39, ($0.03) for the second quarter, as compared with the previously reported ($0.01) and $0.10 for the third quarter, as compared with the previously reported $0.08. In addition we have added a new foreign exchange (gain) loss line to our financial statements for greater transparency (1) The quality of being able to see through a material. The terms transparency and translucency are often used synonymously; however, transparent would technically mean "seeing through clear glass," while translucent would mean "seeing through frosted glass." See alpha blending. Legal and Regulatory Office of the Attorney General On July 24, 2003 Biovail received a letter from the Department of Justice for the Boston Attorney General's office requesting information on the marketing activities surrounding sur·round tr.v. sur·round·ed, sur·round·ing, sur·rounds 1. To extend on all sides of simultaneously; encircle. 2. To enclose or confine on all sides so as to bar escape or outside communication. n. the launch of Cardizem(R) LA. Over the past several months, Biovail has provided documents to the Office of the Inspector General Office of the Inspector General (or OIG) is a common sub-agency within cabinet-level agencies of the United States federal government and serves as auditing and investigative arm of the agency's programs focused on identifying waste, fraud and abuse. and met with representatives of the Department of Justice to discuss this matter. Biovail is continuing to cooperate in respect of this enquiry but at this time, it is difficult to predict when this matter will come to resolution. U.S. Securities and Exchange Commission (SEC) On, November 20, 2003 Biovail received a letter from the SEC indicating that the Commission will be conducting an informal inquiry relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company's financial performance and certain accounting matters for the fiscal year 2003. Over the past several months, Biovail has provided documents to the SEC and met with representatives of the SEC to discuss this matter. Biovail is continuing to cooperate in respect of this informal enquiry but at this time, it is difficult to predict when this matter will come to resolution. Ontario Securities Commission The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance. (OSC O.S.C. n. short for Order to Show Cause. (See: Order to Show Cause) ) In September 2002, the OSC initiated an extensive, review of the disclosure practices of public companies with a view towards ensuring the integrity of the public markets is always maintained and to ensure that Ontario based public companies listed on the Toronto Stock Exchange Several lists of companies traded on the Toronto Stock Exchange exist, sometimes broken down by sector or market capitalization. Lists for the TSX include: S&P/TSX 60 S&P/TSX Composite Index This is an incomplete were diligent dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d in meeting their disclosure obligations. According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the OSC's website, staff was redeployed in the OSC's Corporate Finance Branch to ensure that all of the largest 100 TSX-listed companies that are headquartered in Ontario were reviewed in fiscal 2003. Biovail was part of the initial disclosure review and continues to work with the OSC to maintain high standards in its commitment to disclosure. In November of last year, Biovail received notification that, "the Ontario Securities Commission is conducting a routine inquiry into the trading of Biovail Corporation." This previously undisclosed OSC investigation is, according to the OSC, in its early stages. It is important to note the Biovail Corporation itself was not involved in any trading activity during the periods in question. Biovail takes the ongoing continuous disclosure review and trading activity investigation very seriously and will continue to fully assist the OSC with these important initiatives. Biovail management will host a conference call and web cast on Wednesday, March 3rd, 2003 at 8:00 a.m. EST EST electroshock therapy. EST abbr. electroshock therapy for company executives to discuss 2003 fourth quarter earnings. Following the discussion, Biovail executives will address inquiries from research analysts. A live web cast of this call will be available through the Investor Relations Investor relations The process by which the corporation communicates with its investors. section of the Biovail web site, www.biovail.com. To access this live call, please dial 1-800-814-4853 (U.S. and Canada) and 1-416-640-1907 for international callers. Callers are encouraged to dial in ten minutes before the call begins to avoid delays. A replay of the conference call will be available until 7:00 p.m. EST P.M. also p.m. or p.m. abbr. post meridiem Usage Note: By definition, 12 a.m. on Wednesday March 10, 2004 by dialing 1-877-289-8525 (U.S. and Canada) or 1-416-640-1917 for international callers, using access code, 21037415. Biovail Corporation is an international full-service 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. For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. "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 forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of Section 27A of the Securities Act of 1933, as amended a·mend v. a·mend·ed, a·mend·ing, a·mends v.tr. 1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive. 2. , and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or are forward-looking statements. Forward-looking statements include, but are not necessarily limited 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 and finished products, third parties, 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.
BIOVAIL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(All dollar amounts are expressed in thousands of U.S. dollars,
except per share data)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31 December 31
----------------------- -----------------------
2003 2002 2003 2002
----------- ----------- ----------- -----------
REVENUE
Product sales $ 168,269 $ 183,836 $ 632,898 $ 645,986
Research and
development 3,424 9,257 14,239 28,425
Co-promotion, royalty
and licensing 28,042 45,604 176,585 113,614
----------- ----------- ----------- -----------
199,735 238,697 823,722 788,025
----------- ----------- ----------- -----------
EXPENSES
Cost of goods sold 50,633 43,692 139,456 164,706
Research and
development 26,143 12,603 86,570 52,150
Selling, general and
administrative (note) 66,335 43,526 242,771 166,397
Amortization 26,245 28,977 140,895 71,499
Acquired research and
development 22,111 167,745 124,720 167,745
Write-down of assets 45,081 30,575 45,081 31,944
Extinguishment of
royalty obligation 61,348 - 61,348 -
Settlements - - (34,055) -
----------- ----------- ----------- -----------
297,896 327,118 806,786 654,441
----------- ----------- ----------- -----------
Operating income (loss) (98,161) (88,421) 16,936 133,584
Interest income 1,272 749 7,165 3,608
Interest expense (10,392) (9,252) (40,421) (32,005)
Foreign exchange gain
(loss) (note) (4,413) 1,069 (14,007) 700
Other income (expense) (1,644) 165 (938) 3,408
----------- ----------- ----------- -----------
Income (loss) before
provision for
(recovery of)
income taxes (113,338) (95,690) (31,265) 109,295
Provision for
(recovery of)
income taxes (17,300) 7,100 (4,000) 21,500
----------- ----------- ----------- -----------
Net income (loss) $ (96,038) $(102,790) $ (27,265) $ 87,795
=========== =========== =========== ===========
Diluted earnings (loss)
per share $ (0.60) $ (0.65) $ (0.17) $ 0.55
=========== =========== =========== ===========
Weighted average number
of common shares
outstanding (000s) 159,322 158,099 159,919 160,463
=========== =========== =========== ===========
Note: Current and prior years' figures reflect the reclassification
of foreign exchange gains and losses from selling, general and
administrative expenses.
BIOVAIL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)
December 31
-----------------------
2003 2002
----------- -----------
ASSETS
Cash and cash equivalents $ 133,261 $ 56,080
Other current assets 279,191 265,551
Long-term investments 113,546 79,324
Property, plant and equipment, net 173,804 136,784
Goodwill, net 100,814 102,212
Intangible assets, net 1,049,475 1,080,503
Other assets, net 72,683 113,350
----------- -----------
$1,922,774 $1,833,804
=========== ===========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $ 401,890 $ 345,158
Deferred revenue 14,500 18,200
Minority interest 679 -
Long-term obligations 624,110 624,760
Shareholders' equity 881,595 845,686
----------- -----------
$1,922,774 $1,833,804
=========== ===========
BIOVAIL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)
Twelve Months Ended
December 31
-----------------------
2003 2002
----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES
Net income (loss) $ (27,265) $ 87,795
Add (deduct) items not involving cash
Depreciation and amortization 157,317 82,368
Amortization of deferred financing costs 2,975 2,267
Amortization of discounts on long-term
obligations 6,562 5,329
Acquired research and development 124,720 167,745
Write-down of assets 45,081 31,944
Other items not involving cash 5,893 (1,409)
----------- -----------
315,283 376,039
Net change in non-cash operating items (33,304) (41,935)
----------- -----------
Cash provided by operating activities 281,979 334,104
CASH FLOWS FROM INVESTING ACTIVITIES (278,446) (792,467)
CASH FLOWS FROM FINANCING ACTIVITIES 72,523 79,533
Effect of exchange rate changes on
cash and cash equivalents 1,125 19
----------- -----------
Increase (decrease) in cash and cash
equivalents 77,181 (378,811)
Cash and cash equivalents, beginning
of period 56,080 434,891
----------- -----------
Cash and cash equivalents, end of period $ 133,261 $ 56,080
=========== ===========
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