Biovail Reports Second-Quarter 2008 Financial Results.Company Records Total Revenues of $186 Million; U.S. GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). Loss Per Share of $0.16, Including Net Negative Impact From Specific Items of $0.53; Implementation of New Strategic Focus on Track TORONTO -- 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) today announced financial results for the three-month and six-month periods ended June 30, 2008. To the extent that this news 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 the Company's current views, and actual outcomes are not certain. For more information, see the note on forward-looking information following the conference call details in this news release. "We have made progress in the implementation of our New Strategic Focus and the transformation of Biovail," said Biovail Chief Executive Officer Bill Wells Bill Wells (born Falkirk) is a Scottish bassist, pianist, guitarist and composer. He is best known for his group the Bill Wells Octet, since the early 1990s, but he has performed and recorded in a wide range of settings, including collaborations with The Pastels, Maher . "Our cost-efficiency initiatives are beginning to produce results, our business-development efforts are extremely active, and Biovail's balance sheet and cash balances are robust. Operating cash flows Operating cash flow Earnings before depreciation minus taxes. Measures the cash generated from operations, not counting capital spending or working capital requirements. are also strong. Across all levels of the organization, Biovail's employees are eager to do their part to implement the Company's new strategy." Financial Results Total revenues for the three months ended June 30, 2008 were $186.1 million, compared with $203.0 million for the second quarter of 2007. Total revenues for the six months ended June 30, 2008 were $394.6 million, compared with $450.0 million for the first six months of 2007. Second-quarter 2008 net income, in accordance 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 a loss of $25.3 million, compared with net income of $67.8 million for the corresponding 2007 period. Net income for the first half of 2008 was $31.1 million, compared with $161.6 million in the same period a year earlier. On a per-share basis, Biovail recorded a GAAP 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 $0.16 for the second quarter of 2008, compared with earnings per share (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 $0.42 for the second quarter of 2007. In the first half of 2008, GAAP EPS were $0.19, compared with EPS of $1.01 for the first half of 2007. Specific Items Affecting Operations The following table displays specific items that affected results in the second quarter and first half of 2008 and 2007, respectively, and the impact of each individual item on diluted EPS. [TABLE OMITTED] In the second quarter of 2008, Biovail accrued ac·crue v. ac·crued, ac·cru·ing, ac·crues v.intr. 1. To come to one as a gain, addition, or increment: interest accruing in my savings account. 2. a $51.8-million charge related to the planned closure of the Company's Puerto Rico Puerto Rico (pwār`tō rē`kō), island (2005 est. pop. 3,917,000), 3,508 sq mi (9,086 sq km), West Indies, c.1,000 mi (1,610 km) SE of Miami, Fla. manufacturing facilities and the pending closure of its research and development facility in Dublin, Ireland. In addition, Biovail incurred a charge of $24.6 million related to an agreement-in-principle with the U.S. Department of Justice related to their investigation into the 2003 commercial launch of Cardizem[R] LA. Biovail also incurred costs of $6.1 million in expenses in the second quarter of 2008 related to management succession; $5.4 million associated with the recently resolved proxy contest Proxy contest A battle for the control of a firm in which a dissident group seeks, from the firm's other shareholders, the right to vote those shareholders' shares in favor of the dissident group's slate of directors. Also called proxy fights. regarding the election of the Board of Directors; and a $0.5-million loss on 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. of investments, relating primarily to the Company's portfolio of auction rate securities. These charges were partially offset by a $3.5-million gain on the sale of Biovail's investment in Financiere Verdi (formerly Ethypharm S.A.). These specific items had an aggregate negative impact of $84.9 million in the second quarter of 2008, or $0.53 per common share. In the second quarter of 2007, Biovail incurred a charge of $0.9 million associated with the December 2006 restructuring of the Company's U.S. commercial operations, and a loss of $12.5 million on the 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 the Company's Senior Subordinated Notes, which includes a $7.9-million premium for the early redemption, and the write-off of $4.6 million in deferred financing and other associated costs. Biovail also recorded a $0.5-million equity loss in the second quarter of 2007 relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the Company's investment in Western Life Sciences Venture Fund. Offsetting these items was a $15.7-million gain associated with the April 2007 sale of a portion of the Company's investment in Ethypharm S.A., and a $1.6-million reversal in accrued contract-cost provisions, primarily related to the Wellbutrin XL[R] agreement as a result of additional sample purchases by GlaxoSmithKline plc (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ) in the second quarter of 2007. These specific items had an aggregate positive impact to net income of $3.5 million, or $0.02 per common share. New Strategic Focus In May 2008, Biovail announced a New Strategic Focus - one that leverages the Company's existing strengths to target unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs in the therapeutic area of specialty central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) disorders. This shift in strategy was necessary given ongoing changes in the global pharmaceutical marketplace, including heightened cost-containment pressures and intellectual-property regulations, and shorter product lifecycles Product lifecycle or product life cycle is the course of a product's sales and profits over time. The five stages of each product lifecycle are product development, introduction, growth, maturity and decline. . Since then, the Company has made progress in its product-procurement activities targeted towards specialty CNS disorders, and is currently reviewing a number of in-licensing or acquisition opportunities. Biovail is also assessing a number of private and public pharmaceutical companies active in the specialty CNS market for potential acquisition. Biovail is enhancing its senior management team and internal expertise in CNS disorders, as it implements its New Strategic Focus. In June 2008, the Company appointed Dr. Robert Butz as Vice-President, Medical and Scientific Affairs. Dr. Butz brings over 30 years of experience in the pharmaceutical industry, including tenures at Burroughs Wellcome, Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. Transnational, Amylin Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical company based in San Diego, CA, that was founded in 1987. Currently, Amylin produces two drugs, Symlin (pramlintide acetate) and Byetta (exenatide). Amylin also is working on producing a drug based on Leptin. , Sensus Drug Development Corporation and MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there Pharma Services. Throughout his career, Dr. Butz has been involved in the development of over a dozen CNS programs. Biovail is currently recruiting a Chief Scientific Officer, and has met with a number of qualified candidates to fill the role. Biovail is also active in its efforts to establish a Scientific Advisory Board to provide oversight to its product-development pipeline. Operating-Efficiency Initiatives Also in May, Biovail announced it was taking steps to close the Company's two Puerto Rico manufacturing facilities and transfer certain manufacturing processes to its Steinbach, Manitoba
Steinbach is a city of approximately 12,000 people (2007 est.) (11,066 - 2006 census) in the province of Manitoba, Canada, a short distance from the capital Winnipeg. facility. These closures, which are expected to take 18 to 24 months to complete, are intended to reduce the Company's cost infrastructure and increase available capital. Biovail is also planning the closure of its research-and-development facility in Dublin, Ireland, and the consolidation of the activities conducted therein to the Company's R&D site in Chantilly, Virginia Chantilly is an unincorporated community located in western Fairfax County and southeastern Loudoun County of Northern Virginia. Recognized by the U.S. Census Bureau as a census designated place (CDP), the community population was 41,041 as of the 2000 census. . A consultation process with employees in Ireland in respect of this closure is ongoing. Biovail has begun the sale process relating to its Puerto Rican Puer·to Ri·co Abbr. PR or P.R. A self-governing island commonwealth of the United States in the Caribbean Sea east of Hispaniola. facilities and will initiate similar efforts for the Company's Irish facility upon confirmation of its closure. The closure of these three facilities will result in a reduction of headcount of about 300 employees - representing approximately 20% of Biovail's total headcount - without any anticipated impact to the Company's existing revenue base. Non-Core Asset Sales In June 2008, Biovail sold its economic interest (common shares and convertible securities) in Financiere Verdi for proceeds of $12.2 million. Biovail is exploring the divestiture The breakup of AT&T. By federal court order, AT&T divested itself on January 1, 1984 of its 23 operating companies, which became known as the Regional Bell Operating Companies (RBOCs). and/or monetization Monetization The securitization of the gross revenues of a contract. of other non-core assets, including its facilities in Puerto Rico and Ireland, which the Company believes could, in aggregate, result in cash proceeds in excess of $100 million. Share Repurchase Share Repurchase A program by which a company buys back its own shares from the marketplace, reducing the number of outstanding shares. This is usually an indication that the company's management thinks the shares are undervalued. Program Under the Company's ongoing share repurchase program, 2.3 million shares were purchased and cancelled from June 2, 2008 to June 23, 2008 at a cost of $25.5 million. Biovail's Board has approved the purchase of up to 14 million shares, subject to regulatory filings and approvals, under the program, which expires June 1, 2009. Biovail's credit facility currently restricts any share purchases to $50 million per calendar year and any purchases beyond this threshold require lender consent. Second-Quarter 2008 Financial Performance The following table summarizes Biovail's product revenue performance in the second quarter and first half of 2008: [TABLE OMITTED] Product revenues for the second quarter of 2008 were $175.7 million, compared with $190.8 million in the second quarter of 2007, an 8% decrease that primarily reflects the introduction of generic competition for the 150mg 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. strength of Wellbutrin XL[R] and lower revenues for Cardizem[R] LA. Partially offsetting these declines were increases in revenues from the Company's portfolio of generic products, Legacy products, 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 ) and, Zovirax[R]. Product revenues for the six months ended June 30, 2008 were $372.6 million compared with $428.8 million for the six months ended June 30, 2007. Product revenues for Wellbutrin XL[R] were $30.4 million in the second quarter of 2008, and $89.3 million in the first half of 2008, compared with $53.0 million and $114.5 million in corresponding periods in 2007, respectively. These decreases reflect the December 2006 and May 2008 introduction of generic competition for the 300mg and 150mg dosage strengths, respectively, of the product. Biovail recorded revenues of $19.2 million for Ultram[R] ER in the second quarter of 2008, compared with $19.6 million in the corresponding period in 2007. In the first half of 2008, Ultram[R] ER generated revenues of $43.3 million, compared to $49.6 million in the corresponding period in 2008. Year-over-year performance reflects a reduction in inventory levels and the timing of sample shipments, partially offset by a price increase in the first quarter of 2008. In the second quarter of 2008, Ultram[R] ER captured 5.6% of total prescription volume of the tramadol market (including generics). Revenues for Biovail's Zovirax[R] franchise were $37.5 million in the second quarter of 2008, and $74.7 million in the first half of 2008, representing increases of 7% and 3%, respectively, when compared with $35.2 million and $72.5 million in the prior-year periods. The increases reflect the timing of wholesaler inventory purchases and a January 2008 price increase. In the second quarter of 2008, 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 held a combined 75.1% share of the topical 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. Second-quarter 2008 revenues for BPC were $18.4 million, compared with $14.1 million in the prior-year period. First-half 2008 revenues for BPC were $34.7 million, compared with $27.9 million in the first half of 2007. The increases reflect higher sales of Wellbutrin[R] XL, Tiazac[R] XC, Glumetza[R] and Ralivia[TM] which was launched in November 2007. Wellbutrin[R] XL continues to gain market share, capturing 46% of total prescriptions written for the Wellbutrin[R] brand in the second quarter of 2008. Tiazac[R] XC continues to gain market share, capturing 39% of total prescriptions written for the Tiazac[R] brand in the second quarter of 2008. Partially offsetting factors were lower sales of Tiazac[R], Zyban[R] and Wellbutrin[R] SR. In the second quarter of 2008, Cardizem[R] LA generated revenues of $10.5 million, compared with $22.7 million for the corresponding period in 2007. In the first half of 2008, Cardizem[R] LA generated revenues of $20.7 million, compared with $46.6 million in the first half of 2007. The decreases in sales for the three and six months ended June 2008 reflects lower prescription volumes for the product, partially offset by price increases. In addition, sales were unusually high in the first six months of 2007 due to the fulfillment ful·fill also ful·fil tr.v. ful·filled, ful·fill·ing, ful·fills also ful·fils 1. To bring into actuality; effect: fulfilled their promises. 2. of backorders for the 120mg and 180mg strength tablets of the product in the first quarter of 2007. Legacy products generated revenues of $40.2 million in the second quarter of 2008 and $73.3 million in the first half of 2008, compared with $34.9 million and $70.6 million in the corresponding periods in 2007, respectively. This performance primarily reflects the impact of price increases, partially offset by lower prescription volumes. Product revenue for Biovail's portfolio of generic products, distributed by Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in Ltd. (Teva), was $18.9 million in the second quarter of 2008, compared with $11.3 million in the second quarter of 2007, which was impacted by a higher-than-expected level of charge-backs processed by Teva. In the first half of 2008, Biovail's generic products generated revenues of $36.2 million, compared with $47.1 million in the first half of 2007, reflecting lower sales of Biovail's generic formulations of Adalat CC and Procardia XL. Research-and-development revenue was $5.7 million in the second quarter of 2008, compared with $7.4 million in the prior-year period, a decrease of 23% that reflects a $1.9-million payment from Kos in the second quarter of 2007 related to development activity for Vasocard[TM] prior to the project's termination. Revenues for the first half of 2008 increased 7% compared with the corresponding period of 2007, which reflects increased activity levels at Biovail's Contract Research Division. Royalty and other revenue was $4.7 million in the second quarter of 2008 and $9.0 million in the first half of 2008, compared with $4.9 million and $9.0 million in the corresponding periods in 2007, respectively. 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 second quarter of 2008 was $43.9 million, compared with $54.5 million in the second quarter of 2007. Gross margins based on product sales were 75.0% and 73.8% in the second quarter and first half of 2008, respectively, compared with 71.4% and 74.1% in the corresponding 2007 periods. Gross margins in the second quarter of 2008 were positively impacted by price increases and a reduction in inventory reserves. In the second quarter of 2007, gross margins were negatively impacted by a higher-than-expected level of charge-backs processed by Teva (described above). Research-and-development expenditures were $21.8 million for the second quarter of 2008 and $58.1 million for the first half of 2008, compared with $28.4 million and $58.2 million for the corresponding periods in 2007, respectively. The year-over-year changes reflect decreased spending for BVF-146 (tramadol/NSAID combination), which was recently discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: , and Aplenzin[TM] (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. salt), which received 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. approval in April 2008. Biovail is in active discussions with potential partners for the commercialization of Aplenzin[TM] in the United States. The Company is also evaluating other commercialization options for the product, including co-promotion opportunities and the use of a contract sales organization. Selling, general and administrative (SG&A) expenses for the second quarter of 2008 were $56.6 million, compared with $46.3 million in the second quarter of 2007. SG&A expenses for the first half of 2008 were $100.2 million, compared with $95.9 million in the corresponding period in 2007. These increases reflect expenses of $5.4 million associated with the recent proxy contest and $6.1 million in expenses related to management succession, which includes $2.1 million in non-cash expenses Noun 1. non-cash expense - an expense (such as depreciation) that is not paid for in cash disbursal, disbursement, expense - amounts paid for goods and services that may be currently tax deductible (as opposed to capital expenditures) associated with the accounting for stock-based compensation. Also contributing to the increase were higher payments to Sciele Pharma, Inc. ($5.5 million in the second quarter of 2008, compared with $3.7 million in the prior-year period), related to their promotional efforts for Zovirax[R] and an increase in advertising and promotional expenses Noun 1. promotional expense - the cost of promoting a product business expense, trade expense - ordinary and necessary expenses incurred in a taxpayer's business or trade ($5.6 million in the second quarter of 2008, compared with $3.2 million in the prior-year period), primarily related to the launch of Ralivia[TM] in Canada. Partially offsetting factors include lower legal costs, which totaled $9.1 million in the second quarter of 2008, compared with $13.9 million in the prior-year period. Amortization expense was $11.7 million in the second quarter of 2008 and $23.4 million in the first half of 2008, compared with $12.0 million and $24.0 million in the second quarter and first half of 2007, respectively. Balance Sheet & Cash Flow At June 30, 2008, Biovail had cash balances of $354.1 million and marketable securities Marketable Securities Very liquid securities that can be converted into cash quickly at a reasonable price. Notes: Marketable securities are very liquid as they tend to have maturities less than one year, and the rate at which these securities can be bought or sold has of $23.1 million. The Company has no long-term debt Long-Term Debt Loans and financial obligations lasting over one year. Notes: For example debts obligations such as bonds and notes which have maturities greater than one year would be considered long-term debt. and no outstanding borrowings against its $250-million credit facility. Biovail currently has $26.8 million of principal invested in auction-rate securities (ARS), all of which were rated Aaa/AAA at the time of purchase. However, given declines in underlying collateral values, several of these holdings have had their ratings downgraded since the fourth quarter of 2007. Although these securities continue to pay cash interest, Biovail has been unable to liquidate To pay and settle the amount of a debt; to convert assets to cash; to aggregate the assets of an insolvent enterprise and calculate its liabilities in order to settle with the debtors and the creditors and apportion the remaining assets, if any, among the stockholders or owners of the its ARS portfolio. As such, the Company has recorded this portfolio at its estimated fair value of $13.5 million as at June 30, 2008 and has recorded a further impairment charge of $0.3 million in the second quarter of 2008. To date, the Company has recorded cumulative impairment charges of $9.2 million in respect of these securities. In addition, the Company has recorded a cumulative amount of $4.1 million as an unrealized loss Unrealized Loss A loss that results from holding onto an asset rather than cashing it in and officially taking the loss. Notes: Let's say you own a stock that is down 50%, but you haven't sold it to realize the loss yet. This is said to be an unrealized loss. in other comprehensive income. 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 was $67.1 million in the second quarter of 2008, compared with $98.3 million in the second quarter of 2007, which reflects changes in working capital, increased costs related to the proxy contest and management succession and a modest decline in gross profit due primarily to the genericization of the 150mg strength of Wellbutrin XL[R] product in May 2008. Net capital expenditures in the second quarter of 2008 amounted to $7.7 million, compared with $7.4 million in the prior-year period. Capital expenditures are expected to decrease going forward, with the closure of the Company's Puerto Rico manufacturing facilities. Outlook Biovail is making progress in the implementation of its New Strategic Focus. Over the next several quarters, the Company's ongoing and planned efficiency initiatives are expected to result in additional charges to earnings. Cumulatively, these charges, including those recorded in the second quarter of 2008, are expected to be in the range of $80 million to $100 million, of which the cash component is expected to be $30 million to $40 million. Cost-efficiency initiatives, which should gradually lower expenses, include the previously disclosed closure of the Company's two manufacturing facilities in Puerto Rico and the potential closure of our research-and-development site in Dublin, Ireland. In addition, the Company's recent resolution of several legacy 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. matters should also contribute to lower overall expenses. Biovail anticipates total annual savings of $30 million to $40 million once all initiatives are completed. Biovail expects year-over-year decreases in its product sales for the next several quarters, mainly as a result of the second-quarter 2008 introduction of generic competition on the 150mg strength of Wellbutrin XL[R]. Biovail does not anticipate meaningful revenue contribution from its development pipeline until the 2010-2011 timeframe. Biovail plans to invest over $600 million in research and development through 2012, targeting unmet medical needs in specialty CNS markets. Business-development efforts to in-license or acquire products targeting specialty CNS markets are active with a number of U.S. and international companies. Conference Call Biovail management will host a conference call and Webcast on Wednesday, August 13, 2008, at 8:30a.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 second-quarter 2008 financial and operational 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 Biovail's Web site at www.biovail.com. To access the call live, please dial 416-695-6617 (Toronto and International callers) and 1-800-952-6845 (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 Wednesday, August 20, 2008, by dialing 416-695-5800 (Toronto and International callers) and 1-800-408-3053 (U.S. and Canada), using access code, 3266755#. 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 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 under 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 and outlook, including, without limitation, statements concerning the Company's New Strategic Focus, including the Company's intention and ability to implement and effectively execute elements of its New Strategic Focus and the anticipated impact of the Company's New Strategic Focus, the intent, timing and associated costs of the proposed closure of the Company's Puerto Rico and Ireland facilities and other efficiency initiatives, the Company's intent and ability to make purchases under its share repurchase program, the outcome of business development efforts, the expected impact of the introduction of generic competition on the 150mg strength of Wellbutrin XL[R], the amount and timing of expected contribution from the Company's development pipeline and the amount and timing of investment in research and development and can generally be identified by the use of 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 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, including, but not limited to, factors and assumptions regarding prescription trends, pricing and the formulary formulary /for·mu·lary/ (for´mu-lar?e) a collection of recipes, formulas, and prescriptions. National Formulary see under N. for·mu·lar·y n. and/or Medicare/Medicaid positioning for our products, the competitive landscape in the markets in which we compete, including, but not limited to, the availability or introduction of generic formulations of our products, timelines associated with the development of, and receipt of regulatory approval for, our new products, 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: the difficulty of predicting U.S. Food and Drug Administration and 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. approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, uncertainties associated with the development, acquisition and launch of new products, reliance on key strategic alliances, contractual disagreements with third parties, availability of raw materials and finished products, the regulatory environment, the expense, timing and uncertain outcome of legal and regulatory proceedings and settlements thereto there·to adv. 1. To that, this, or it. 2. Archaic In addition to that; furthermore. thereto Adverb Formal 1. to that or it 2. , market liquidity for our common shares and our satisfaction of applicable laws for the repurchase re·pur·chase tr.v. re·pur·chased, re·pur·chas·ing, re·pur·chas·es To buy (something) again. n. The act of buying something that one previously sold or owned. Noun 1. of our common shares, the results of the upcoming U.S. presidential election, consolidated tax rate assumptions, 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 Canadian Securities Administrators Canadian Securities Administrators(CSA) is a forum for the 13 securities regulators of Canada's provinces and territories to coordinate and harmonize regulation of the Canadian capital markets. , 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, as well as under the heading "Risk Factors" contained in Item 3(D) of Biovail's most recent Annual Report on Form 20-F/A. 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. The Company is focused on the development and commercialization of medicines that address unmet medical needs in niche specialty central nervous system (CNS) markets. 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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