Biovail Reports Record Fourth Quarter, Year-End 2006 Financial Results.Company Achieves Record Revenues of $308 Million in Fourth Quarter, $1.07 Billion in Full-Year 2006; GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. of $0.72 in Fourth Quarter, $1.27 in Full-Year 2006 EPS Excluding Specific Items of $0.93 in Fourth Quarter, $2.70 in Full-Year 2006; Record Cash Flows From Operations of $236 Million in Fourth Quarter, $523 Million in Full-Year 2006; Year-End Cash Balances in Excess of $830 Million TORONTO -- Biovail Corporation (NYSE/TSX: BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency ) today announced financial results for the three-month and 12-month periods ending December 31, 2006. To the extent that this press release contains 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. , investors are cautioned that these are based on our current views, and actual outcomes are not certain. Please see the note on forward-looking information following the conference-call details below. Total revenues for the three months ended December 31, 2006 were $307.6 million, compared with $287.6 million for the fourth quarter of 2005, an increase of 7%. Total revenues for the 12 months ended December 31, 2006 were $1.07 billion, compared with $935.5 million for the full year of 2005, an increase of 14%. Fourth-quarter 2006 net income, 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 United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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), was $115.3 million, compared with $119.7 million for the corresponding 2005 period. For the 12 months ended December 31, 2006, net income was $203.9 million, compared with $236.2 million for the same period a year earlier. GAAP 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 (EPS) for the fourth quarter of 2006 were $0.72, versus $0.75 for the fourth quarter of 2005. For the full year of 2006, GAAP EPS were $1.27, versus EPS of $1.48 for the full year of 2005. Specific Items Affecting Fourth-Quarter Results GAAP net income and EPS figures for the fourth quarter of 2006 were negatively impacted by a $15.1-million charge related to the December 2006 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). of the Company's U.S. commercial operations, an $11.7-million payment representing the Company's share of the costs associated with a litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. settlement between GlaxoSmithKline plc (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) and 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. (Watson), a $2.7-million litigation settlement related to the Company's licensing in 1999 of Adalat CC products from Elan (Emulated LAN) A virtual LAN in the ATM world. See LANE and virtual LAN. Elan - ["Top-down Programming with Elan", C.H.A. Koster, Ellis Horwood 1987]. Corporation, plc (Elan), an additional $1.9-million provision related to a contract-loss provision in the Wellbutrin XL[R] agreement with GSK, and an additional $1.6-million charge related to a lost-profits provision in the Company's agreement with Kos Pharmaceuticals, Inc. (Kos) pertaining per·tain intr.v. per·tained, per·tain·ing, per·tains 1. To have reference; relate: evidence that pertains to the accident. 2. to Cardizem[R] LA. These items negatively impacted fourth-quarter 2006 net income by $33.1 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. EPS by $0.21. Accordingly, Net Income Excluding Specific Items and EPS Excluding Specific Items in the fourth quarter of 2006 were $148.4 million and $0.93, respectively. GAAP net income and EPS figures for the fourth quarter of 2005 were negatively impacted by a net charge of $2.6 million, primarily related to the write-down of the Company's investment in Reliant Pharmaceuticals. For more information concerning Net Income Excluding Specific Items and EPS Excluding Specific items, please refer below to Table 1 - Reconciliation of U.S. GAAP Net Income and EPS to Net Income Excluding Specific Items and EPS Excluding Specific Items, and "Use of Non-GAAP Financial Measures". Specific Items Affecting Full-Year 2006 Results In addition to the items affecting results for the fourth quarter of 2006, GAAP net income and EPS figures for the full year of 2006 were impacted by a $147.0-million non-cash write-down of 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. , an initial $44.5-million charge related to the GSK contract-loss contingency, an initial $6.8-million charge related to the lost-profits provision in the Kos agreement; a $0.5-million equity loss in the Company's investment in Western Life Sciences, and a $1.1-million asset impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. charge related to Nutravail; partially offset by a $4.0-million gain related to the termination of the Athpharma agreement. In aggregate, these items negatively impacted net income and EPS in 2006 by $228.9 million and $1.43, respectively. Accordingly, Net Income Excluding Specific Items and EPS Excluding Specific Items in 2006 were $432.9 million and $2.70, respectively. GAAP net income and EPS for the full-year of 2005 were negatively impacted in the amount of $60.6 million and $0.38, respectively, as a result of a restructuring charge restructuring charge The expense of reorganizing a company's operations. A restructuring charge is an infrequent expense that generally results from asset writedowns or facility closings. , an equity loss, a non-cash write-down of assets and the write-off of inventory related to the transaction with Kos in May 2005. "Biovail once again performed well against its financial objectives, surpassing the $1 billion mark in total revenues for the first time, generating over $520 million in 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 in 2006, and ending the year with over $830 million in cash," said Biovail Chief Executive Officer Dr. Douglas Squires. "Despite the earlier-than-anticipated launch of a generic formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation of Wellbutrin XL[R] 300mg tablets, the strong cash-flow generation of the Company's business model should allow Biovail to grow its business through focused investments in research and development, while providing the flexibility for substantial dividend payments to our shareholders." Revised U.S. Commercialization Strategy In December 2006, Biovail announced that it would leverage strategic partners to promote its products to specialist physicians in the United States, which is consistent with the Company's approach to commercializing products in the U.S. primary-care market since the May 2005 strategic alliance with Kos. As a result, the Biovail Pharmaceuticals, Inc. (BPI (Bits Per Inch) The measurement of the number of bits stored in one linear inch of a track (storage channel) on a disk or tape. Bit density on magnetic disks has reached 800,000 bpi (800 Kbpi). See tpi, areal density and magnetic disk. BPI - bits per inch ) specialty sales force and related support functions were eliminated. Given these changes, BPI ceased co-promotional efforts for Ultram[R] ER and Zoladex 3.6mg. With respect to Zovirax[R], in December 2006, Biovail entered into an exclusive promotional-services agreement with Sciele Pharma, Inc. (Sciele) whereby Sciele's Primary Care and Women's Health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. sales forces now promote Zovirax[R] Ointment ointment /oint·ment/ (oint´ment) a semisolid preparation for external application to the skin or mucous membranes, usually containing a medicinal substance. oint·ment n. and Zovirax[R] Cream to U.S. physicians. Under the terms of the agreement, which has an initial term of five years, Biovail compensates Sciele for providing detailing and sampling support for the products. In addition, Sciele is 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 incentive fees if certain baseline revenue targets are met. Revised Dividend Policy Also in December 2006, Biovail's Board of Directors adopted a new dividend policy that contemplates the payment of an annual dividend of $1.50 per common share (paid quarterly in increments of $0.375 per common share subject to Board approval), a 200% increase relative to the Company's former policy. In addition, Biovail may approve the payment of future special dividends. Biovail's dividend policy is subject to positive business trends and the discretion of the Board, and is representative of management's confidence in the sustainability of strong cash flows and the strength of the Company's business model. Redemption of Debt Effective April 1, 2007, Biovail will redeem redeem v. to buy back, as when an owner who had mortgaged his/her real property pays off the debt. The term also refers to paying the amount due and all charges after a foreclosure (due to failure to make payments when due) has begun. all of its outstanding 7 7/8% Senior Subordinated Notes due April 1, 2010. As per the indenture An agreement declaring the benefits and obligations of two or more parties, often applicable in the context of Bankruptcy and bond trading. The term indenture primarily describes secured contracts and has several applications in U.S. law. governing the Notes, the Company will be required to pay a 1.969% premium for the early redemption. From a cash earnings-per-share perspective in 2007, the redemption is expected to be neutral, as the significant savings in interest expense will be offset by the call premium and lower interest income on cash balances. Wellbutrin XL[R] Settlement On March 5, 2007, Biovail announced that, following a review by the Federal Trade Commission (FTC FTC See Federal Trade Commission (FTC). ) that was requested by the parties, a comprehensive settlement had been reached with Anchen Pharmaceuticals LLP LLP - Lower Layer Protocol , Impax Laboratories, Inc., Watson and Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. related to Wellbutrin XL[R]. The settlements include, among other things, the dismissal of Biovail's patent-infringement actions against each of Impax and Watson related to their abbreviated new drug applications 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 for generic formulations of Wellbutrin XL[R]. Under the terms of the agreement, with defined exceptions, none of Teva, Anchen, Impax, and Watson may market a generic version of the 150mg strength of Wellbutrin XL[R] until 2008. For more information, see the news release issued March 5, 2007, Biovail Announces Comprehensive Settlement Related to Wellbutrin XL[R]. Fourth-Quarter 2006 Financial Performance Product revenues for the fourth quarter of 2006 were $296.0 million, compared with $274.8 million in the fourth quarter of 2005, an 8% increase that reflects the February 2006 launch of Ultram[R] ER, and the positive performances of Wellbutrin XL[R], the Zovirax[R] line and the Company's generic pharmaceuticals portfolio. Partially offsetting factors include declines in revenues from Biovail Pharmaceuticals Canada (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 ), Biovail's Legacy products and Cardizem[R] LA. Product revenues for full-year 2006 were $1.02 billion compared with $884.3 million for 2005, an increase of 16%. Product revenues for Wellbutrin XL[R] were $148.1 million in the fourth quarter of 2006, and $450.3 million in the full year of 2006, compared with $137.7 million and $354.2 million in the corresponding periods in 2005, respectively. In December 2006, a generic formulation of 300mg tablets of Wellbutrin XL[R] was launched in the U.S. Pursuant to a comprehensive settlement in March 2007, with defined exceptions, a generic formulation of 150mg tablets of Wellbutrin XL[R] will not be launched until 2008. In January 2007, Biovail's marketing partner, GSK, announced the first European approval for the product, which will be most commonly marketed as Wellbutrin XR[R]. GSK anticipates that the regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. in various other European countries will grant national licenses throughout 2007, and that the medicine could begin to be available to patients starting April 2007. Pursuant to the agreement signed in 2001 between Biovail and GSK, Biovail will manufacture and supply the product to GSK at a fixed, contractually determined price. Launched in February 2006 by Biovail's strategic partner Ortho-McNeil, Inc. (OMI (1) See Open Market. (2) (Open Microprocessor Initiative, Brussels, Belgium) An organization that functions under the umbrella of the European Commission. It funds projects that research and develop advanced microcontroller technologies. ), Ultram[R] ER generated revenues of $19.2 million in the fourth quarter of 2006, and $53.7 million in the full year of 2006, which is net of a $7.8-million return provision related to the second-quarter 2006 recall of certain dosages of the product. In the last several months, OMI has undertaken a number of initiatives to accelerate prescription growth for Ultram[R] ER, including an unbranded direct-to-consumer (DTC DTC See: Depository Transfer Check DTC See: Depository Trust Company DTC See Depository Trust Company (DTC). ) advertising campaign, a discount-card program and an increase to 30 tablets (from seven) in the size of samples to allow patients to be optimally titrated ti·trate tr. & intr.v. ti·trat·ed, ti·trat·ing, ti·trates To determine the concentration of (a solution) by titration or perform the operation of titration. to higher 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. In addition, in December 2006, Biovail and OMI agreed to invest equal amounts in 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. advertising and promotional support for the product, over and above OMI's contractual obligation. Biovail is currently monitoring the impact of these initiatives. Revenues for Biovail's Zovirax[R] franchise were $31.1 million in the fourth quarter of 2006, and $112.4 million in the full year of 2006, representing increases of 12% and 17%, respectively, when compared with $27.7 million and $95.9 million in the prior-year periods. Revenue growth in 2006 was favorably fa·vor·a·ble adj. 1. Advantageous; helpful: favorable winds. 2. Encouraging; propitious: a favorable diagnosis. 3. impacted by a modest increase in total prescription volume, price increases and a reduction in wholesaler inventory levels in 2005. In the fourth quarter of 2006, Zovirax[R] Ointment and Zovirax[R] Cream held a combined 71.4% share of the U.S. 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. herpes Herpes Any virus of the herpesvirus group, which comprises a family of 70 species, 5 of which are pathogenic to humans; the term also refers to any infection caused by these viruses. market, an increase of 4.6 percentage points in market share versus fourth-quarter 2005 levels. Fourth-quarter 2006 revenues for BPC were $15.7 million, compared with $27.4 million in the prior-year period. BPC revenues for the full year of 2006 were $68.7 million, compared with $99.5 million in the full year of 2005. The year-over-year declines reflect the introduction of generic competition for Wellbutrin[R] SR and Tiazac[R] in the Canadian market. Total prescription volume for Wellbutrin[R] SR and Tiazac[R] decreased 87% and 32%, respectively, in the fourth quarter of 2006, versus the comparable 2005 period. Partially offsetting this decline was the continued growth of Tiazac[R] XC, for which prescription volume increased 77% compared with the fourth quarter of 2005, and the strong performance of Wellbutrin[R] XL (launched April 2006), which captured 21.6% of bupropion bupropion /bu·pro·pi·on/ (bu-pro´pe-on) a monocyclic compound structurally similar to amphetamine, used as the hydrochloride salt as an antidepressant and as an aid in smoking cessation. prescriptions in the fourth quarter of 2006. In the U.S., Cardizem[R] LA generated revenues of $12.4 million in the fourth quarter of 2006, compared with $13.4 million for the corresponding period in 2005. In the full year of 2006, Cardizem[R] LA generated revenues of $59.3 million, compared with $59.7 million in the full year of 2005. The decrease primarily reflects manufacturing issues that resulted in market shortages of the lower-strength (120mg and 180mg) tablets, partially offset by price increases taken by Kos. The amortization of deferred revenues associated with the May 2005 Kos transaction positively impacted Cardizem[R] LA revenues by $3.8 million and $15.1 million in the fourth quarter and full year of 2006, respectively, compared with $3.8 million and $10.0 million in the corresponding periods in 2005. In the second half of 2006, Biovail recorded an $8.4-million charge related to a lost-profits provision in the agreement with Kos, as a result of the manufacturing issue that impacted production of 120mg and 180mg tablets of Cardizem[R] LA. Biovail has now returned to full production of these strengths. Biovail's Legacy products generated revenues of $28.9 million for the fourth quarter of 2006, compared with $35.0 million in the fourth quarter of 2005, a decline of 17% that represents lower sales of Cardizem[R] CD and Tiazac[R]. In the full year of 2006, legacy products generated revenues of $139.9 million, compared with $133.4 million in the full year of 2005, an increase of 5%. This performance is largely attributable to price increases in 2006 and a reduction of wholesaler inventory levels in 2005. Partially offsetting factors include the expected year-over-year declines in total prescription volumes for these mature products. Product revenue for Biovail's portfolio of generic products (distributed by a subsidiary of Teva) was $41.0 million in the fourth quarter of 2006, compared with $33.7 million in the fourth quarter of 2005, a 22% increase that is largely attributable to stronger sales of generic Cardizem[R] CD and the January 2006 launch of an authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: generic of Tiazac[R] in Canada. Full-year 2006 revenues were $141.1 million, compared with $135.2 million in the prior-year period, an increase of 4%. Total prescription volume for these products increased 2% in the fourth quarter and 6% in the full year of 2006. Further to the May 2005 sale to Kos, Biovail no longer has an ongoing financial interest in Teveten and Teveten HCT Hct abbr. hematocrit HCT Hematocrit, see there . However, in 2006, the Company increased its provision for returns related to pre-May 2005 sales of these products by $1.3 million. Performance Summary The following table summarizes Biovail's product revenue performance in the fourth quarter and full year of 2006: [TABLE OMITTED] NM = Not Meaningful Research-and-development revenue increased 5% in the fourth quarter of 2006 to $7.0 million, but decreased 23% to $21.6 million for the full year of 2006, compared with the corresponding periods of 2005. The full-year decline in 2006 reflects reduced activity levels and pricing pressure at the Company's Contract Research Division. Royalty and other revenue was $4.6 million in the fourth quarter of 2006 and $24.9 million in the full year of 2006, compared with $6.1 million and $23.3 million in the corresponding periods in 2005, respectively. The increase in 2006 primarily reflects $3.8 million in co-promotion revenues associated with Ultram[R] ER, partially offset by reduced royalty revenue. Cost of goods sold Cost of goods sold The total cost of buying raw materials, and paying for all the factors that go into producing finished goods. cost of goods sold for the fourth quarter of 2006 was $52.8 million, compared with $53.6 million in the fourth quarter of 2005. Gross margins based on product sales were 82% and 78% in the fourth quarter and full year of 2006, respectively, compared with 81% and 77% in the fourth quarter and full year of 2005, respectively. The year-over-year increases reflect product mix and price increases implemented in 2006, partially offset by manufacturing issues primarily related to Ultram[R] ER and Cardizem[R] LA. Research-and-development expenditures were $28.4 million for the fourth quarter of 2006 and $95.5 million for the full year of 2006, compared with $26.3 million and $88.4 million for the corresponding periods in 2005, respectively. These increases reflect the fourth-quarter 2006 initiation of the Phase 3 program for BVF-146 (combination of once-daily tramadol with an undisclosed non-steroidal anti-inflammatory drug Non-steroidal anti-inflammatory drugs, usually abbreviated to NSAIDs, are drugs with analgesic, antipyretic and anti-inflammatory effects - they reduce pain, fever and inflammation. , or NSAID NSAID: see nonsteroidal anti-inflammatory drug. ). With respect to other pipeline programs, a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) was submitted to the 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. in September 2006 for BVF-033, the Company's novel bupropion salt formulation. The FDA action date for this application is late-July 2007. Active partnership discussions are ongoing for these, and other, pipeline programs. Selling, general and administrative (SG&A) expenses for the fourth quarter and full year of 2006 were $65.1 million and $238.4 million, respectively, compared with $53.1 million in the fourth quarter of 2005, and $227.4 million in the full year of 2005. The increases reflect higher legal expenses primarily related to Wellbutrin XL[R] legal actions, and the inclusion of stock-based compensation expenses of $11.9 million in 2006, in addition to Biovail's contribution to incremental advertising and promotion spending in support of Ultram[R] ER in the fourth quarter. These items were partially offset by savings associated with the Company's May 2005 restructuring of its U.S. commercial operations group. Amortization expense in the fourth quarter of 2006 was $12.0 million, compared with $15.4 million in the fourth quarter of 2005, a 22% decrease that primarily reflects the third-quarter 2006 write-down of intangible assets associated with Vasotec[R] and Glumetza[TM]. In the full year of 2006, amortization expense was $56.5 million, compared with $62.3 million. Specific Items Affecting Operations - Fourth-Quarter 2006 In the fourth quarter of 2006, Biovail incurred a $15.1-million charge, primarily related to 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 costs, associated with the December 2006 restructuring of the Company's U.S. commercial operations; an $11.7-million charge representing the Company's share of the costs associated with a litigation settlement between GSK and Watson; a $2.7-million litigation settlement of the Class Action complaint related to the Company's licensing of Adalat CC products from Elan; an additional $1.9-million provision related to a contract-loss provision in the Wellbutrin XL[R] agreement with GSK; and an additional $1.6-million charge related to a lost-profits provision in the Company's agreement with Kos as a result of the longer-than-anticipated return to full production of the lower strength (120mg and 180mg) tablets of Cardizem[R] LA. Comparatively, in the fourth quarter of 2005, Biovail recorded a $2.7-million charge related to the write down of the Company's investment in Reliant Pharmaceuticals and a $0.4-million equity loss, which was partially offset by a $0.5-million adjustment to the write-down of the Company's Nutravail assets. Specific Items Affecting Operations - Full-Year 2006 In addition to the items in the fourth quarter of 2006, GAAP net income and EPS figures for the full year of 2006 were impacted by a $147.0-million non-cash write-down of intangible assets. This reflects a $132.0-million write-down of the Vasotec[R] product rights as a result of Kos' decision in September 2006 to not proceed with, and Biovail's subsequent termination of, the development of Vasocard[TM]. In addition, upon a reassessment Reassessment The process of re-determining the value of property or land for tax purposes. Notes: Property is usually reassessed on an annual basis. You may request a "reassessment" if you disagree with your assessment. of the Canadian market opportunity for the product, Biovail reduced the carrying value Carrying Value Also know as "book value," it is a company's total assets minus intangible assets and liabilities, such as debt. Notes: This is different than market value, as it can be higher or lower depending on the circumstances. of the Glumetza[TM] product rights by $15.0 million. Further, in the first nine months of 2006, Biovail incurred an initial $44.5-million charge related to the GSK contract-loss contingency, an initial $6.8-million charge related to the lost-profits provision in the Kos agreement, a $0.5-million equity loss in the Company's investment in Western Life Sciences, and a $1.1-million asset impairment charge related to Nutravail. These charges were partially offset by a $4.0-million gain related to the July 2006 termination of the Athpharma agreement. Comparatively, in the full year of 2005, Biovail incurred a $19.8-million restructuring charge, primarily related to severance costs associated with the May 2005 realignment re·a·lign tr.v. re·a·ligned, re·a·lign·ing, re·a·ligns 1. To put back into proper order or alignment. 2. To make new groupings of or working arrangements between. of the Company's U.S. commercial operations. Biovail also incurred $34.8 million in asset write-downs, primarily related to the disposal of the Teveten line, and a $1.2-million equity loss. Additionally, $4.9 million of Cardizem[R] LA and Teveten inventory not purchased by Kos was written off to cost of goods sold in 2005. Specific Items impacting net income and EPS in the fourth quarter and full-year 2006 are outlined below. Table 1. Reconciliation of U.S. GAAP Net Income and EPS to Net Income Excluding Specific Items and EPS Excluding Specific Items [TABLE OMITTED] Use of Non-GAAP Financial Measures Net income excluding specific items ("Net Income Excluding Specific Items") and earnings per share excluding specific items ("EPS Excluding Specific Items") have been provided as Biovail believes they are useful measures for investors and management that facilitate, on an aggregate and on a per-share basis, respectively, operating comparisons between periods. Net Income Excluding Specific Items and EPS Excluding Specific Items exclude the effects of non-cash write downs of certain intangible assets, charges related to contract-loss contingencies and lost-profits provisions in certain agreements, restructuring costs, litigation settlements and gains on the termination of certain agreements. The items are excluded in the determination of such measures because they are either non-cash in nature, non-recurring, or otherwise not considered to be in the ordinary course of business. Such measures do not have any standardized standardized pertaining to data that have been submitted to standardization procedures. standardized morbidity rate see morbidity rate. standardized mortality rate see mortality rate. meanings prescribed pre·scribe v. pre·scribed, pre·scrib·ing, pre·scribes v.tr. 1. To set down as a rule or guide; enjoin. See Synonyms at dictate. 2. To order the use of (a medicine or other treatment). by GAAP, and are therefore unlikely to be comparable to similar measures presented by other companies. Net Income Excluding Specific Items and EPS Excluding Specific Items are not measures of performance under GAAP, and should not be considered in isolation of or as substitutes for net income or earnings per share prepared in accordance with GAAP. Biovail has provided a reconciliation of Net Income Excluding Specific Items to GAAP net income and of EPS Excluding Specific Items to GAAP earnings per share above. Balance Sheet & Cash Flow At the end of December 2006, Biovail's cash balances were $834.5 million, with no outstanding borrowings under its credit facility. Cash flows from continuing operations continuing operations Parts of a business that are expected to be maintained as an ongoing segment of an overall business operation. Income and losses from continuing operations are reported separately if any segments have been discontinued during the were $235.6 million in the fourth quarter of 2006 and $522.5 million in full year of 2006, compared with $223.4 million and $501.9 million in the corresponding periods of 2005. Net capital expenditures amounted to $6.1 million in the fourth quarter of 2006 and $44.8 million in the full year of 2006, compared with $13.7 million in the fourth quarter of 2005 and $37.8 million in the full year of 2005. The increase in 2006 reflects the expansion of the Company's Steinbach manufacturing facility, which is essentially complete. 2007 Guidance As a result of the comprehensive settlement reached with a number of generic pharmaceutical companies, and following an assessment of all aspects of the Company's internal projections and previously issued financial guidance, Biovail has made a number of revisions to its 2007 projections. In particular, Biovail has reflected the positive benefit of the settlement, as well as the negative impact of the absence of an authorized generic of Wellbutrin XL[R] from the market for a period of six months from the first generic entrant en·trant n. One that enters, especially one that enters a competition. [French, from present participle of entrer, to enter, from Old French; see enter. , and the Company's contribution to the cost of the license that GSK acquired from Watson. Further, given prescription trends since November 2006, among other things, and based on OMI's revisions to their demand forecast, Biovail is reducing its internal Ultram[R] ER revenue projections for 2007. The net impact of these factors is such that Biovail is reiterating its 2007 guidance for total revenues of $800 million to $850 million; diluted EPS of $1.70 to $1.80 (excluding specific items), and cash flows from operations of $320 million to $340 million. As before, Biovail's revenue guidance is based on a number of variables, including current prescription and business trends, and the success of our strategic marketing and distribution partners. Biovail's 2007 financial guidance assumes that a generic formulation of the 150mg strength of Wellbutrin XL[R] is not launched in 2007. In addition, 2007 guidance does not include the impact of any potential acquisitions or dispositions; the introduction of new generic formulations of the Company's other key products; any new supply-and-distribution agreements; restructuring; settlements or other specific charges. Further, EPS guidance does not include the impact, if any, of the implementation of Financial Accounting Standards Board Financial Accounting Standards Board (FASB) Board composed of independent members who create and interpret Generally Accepted Accounting Principles (GAAP). Interpretation No. 48 (FIN fin, organ of locomotion characteristic of fish and consisting of thin tissue supported by cartilaginous or bony rays. In some fish, e.g., the eel, a single fin extends from the back, around the tail, and along the ventral surface. 48). Regulatory Matters With respect to regulatory matters, Biovail continues to co-operate fully with the U.S. Securities and Exchange Commission (SEC), 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) ) and other regulatory agencies. Recently, the United States Attorney's Office for the Eastern District of New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of informed Biovail that it was conducting an investigation into the same matters being investigated by the SEC. The outcome or timing of when these matters may be resolved cannot be predicted. The Company will provide updates as material developments in these matters occur. Conference Call Biovail management will host a conference call and Webcast on Thursday, March 15, 2007, at 8:30 a.m. EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT for Company executives to discuss 2006 fourth-quarter and full-year 2006 financial results. Following the discussion, Biovail executives will address inquiries from research analysts. A live Webcast 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 the call live, please dial 416-340-8010 (Toronto and International callers) and 1-866-540-8136 (U.S. and Canada). Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays. A replay of the conference call will be available until 7 p.m. EDT on Thursday, March 22, 2007, by dialing 416-695-5800 (Toronto and International callers) and 1-800-408-3053 (U.S. and Canada), using access code, 3215271#. Caution Regarding Forward-Looking Information and "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 within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information within the meaning of the "safe harbor" provisions of applicable Canadian provincial securities legislation (collectively, "forward-looking statements"). These forward-looking statements relate to, among other things, our objectives, goals, targets, strategies, intentions, plans, beliefs, estimates, outlook and guidance, including, without limitation, statements concerning the Company's commitment to research and development, the Company's ability to make dividend payments to shareholders, the Company's expectations regarding the proposed Notes redemption and expectations regarding the launch of Wellbutrin XR[R] in Europe, expectations regarding the results of initiatives undertaken in respect of Ultram[R] ER, the Company's guidance for 2007 in respect of its total revenues, EPS and cash flows from operations, and can generally be identified by the use of words such as "guidance", "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 are forward-looking statements. Although Biovail believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include, among other things: a decrease in sales of Wellbutrin XL[R], the difficulty of predicting U.S. Food and Drug Administration, Canadian Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. and European regulatory 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, the regulatory environment, tax rate assumptions, the outcome of legal proceedings All actions that are authorized or sanctioned by law and instituted in a court or a tribunal for the acquisition of rights or the enforcement of remedies. , fluctuations in operating results and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities Commission, as well as the Company's ability to anticipate and manage the risks associated with the foregoing. Additional information about these factors and about the material factors or assumptions underlying such forward-looking statements may be found in the body of this news release, and the Company's news release issued March 5, 2007 entitled "Biovail Announces Comprehensive Settlement Related to Wellbutrin XL[R]", as well as under the heading "Risk Factors" contained in Item 3(D) of Biovail's most recent Annual Report on Form 20-F. The Company cautions that the foregoing list of important factors that may affect future results is not exhaustive. When relying on Biovail's forward-looking statements to make decisions with respect to the Company, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Biovail undertakes no obligation to update or revise any forward-looking statement. About Biovail Corporation Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at www.biovail.com. For further information, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to ir@biovail.com. [TABLE OMITTED] [TABLE OMITTED] [TABLE OMITTED] |
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