Biovail Provides Updated 2004 Guidance.Business Editors/Health/Medical Writers TORONTO--(BUSINESS WIRE)--March 3, 2004 Biovail Biovail TSX: BVF NYSE: BVF is Canada's largest pharmaceutical company, operating internationally in all aspects of pharmaceutical products. Its major production facility is located in Steinbach, Manitoba. 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): -- Boasts sales and marketing spending by $40 million to $60 million adding two specialty sales forces -- Increases 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 by $40 million -- Decreases Legacy Product revenues by $80 million to $60 million -- Removes licensing revenue of $35 million from guidance Biovail Corporation (NYSE:BVF) (TSX:BVF) today announced revised revenue and earnings guidance for 2004. The Company believes that the financial guidance contained herein is conservative, achievable and reflects the Company's strategic desire to invest in its Research and Development and Sales and Marketing infrastructure -- balancing return on investment with investments 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. sustainable organic growth. Biovail is updating its previously announced guidance based on several changes within its business including: -- The successful launch of Wellbutrin XL in the U.S. marketplace such that Biovail's licensee licensee n. a person given a license by government or under private agreement. (See: license, licensor) LICENSEE. One to whom a license has been given. 1 M. Q. & S. 699 n. , GlaxoSmithKline, has recently increased their manufacturing orders and revenue guidance; -- Expanding the Company's U.S. sales force with the launch of 63 new specialty sales representatives to focus on Nephrology nephrology Branch of medicine dealing with kidney function and diseases. An understanding of kidney physiology is important not only in treating kidney disease but in knowing the effect of drugs, diet, and hypertension on kidney disease, and vice versa. and 63 new specialty sales representatives to focus on Dermatology dermatology (dûrmətŏl`əjē), branch of medicine concerned with diagnosis and treatment of diseases and disorders of the skin. & OB/GYN OB/GYN A common abbreviation for obstetrics and gynecology . Based on anticipated 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. Wellbutrin revenue, the Company believes this ongoing investment in its U.S. sales force will result in higher revenue long term for its U.S. promoted products and will strengthen Biovail's position in the competitive U.S. marketplace; -- Conservatively reducing revenue expectations for the Company's U.S. promoted products business until the sales force efforts prove successful; -- Conservatively reducing revenue expectations on Legacy brands which are declining faster than previously expected and the Company's need to under-ship demand; and, -- Conservatively removing from the Company's guidance any out-licensing revenue expectation until such time an out-licensing agreement is consummated con·sum·mate tr.v. con·sum·mat·ed, con·sum·mat·ing, con·sum·mates 1. a. To bring to completion or fruition; conclude: consummate a business transaction. b. . The Company is currently in discussions with multiple partners regarding potential product out-licensing opportunities including Ralivia (R), Biovail's once-daily pain formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating. American Law Institute Formulation intended for the treatment of chronic moderate to moderately severe pain. This is consistent with the Company's conservative financial approach. Biovail's anticipated annual product sales revenue by major category, research and development revenue, royalty and co-promote revenue and total revenue for 2004 compared to previous guidance is expected to be within the following ranges:
($millions) Updated
Previous
Promoted products
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Cardizem LA 80 100 90 120
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Teveten 30 40 35 45
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Zovirax 90 110 100 120
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Subtotal 200 250 225 285
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Wellbutrin XL 200 250 160 210
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Biovail Pharmaceuticals Canada 100 120 95 110
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Legacy Products 150 200 230 260
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Generics 110 130 110 135
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Total 760 950 820 1,000
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Total Product Sales Revenue Guidance 800 900 850 1,000
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Research & Development Revenue 10 15 15 20
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Royalty and Co-Promote Revenue 20 25 15 50
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Total 830 940 880 1,070
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Total Revenue Guidance 800 940 880 1,070
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Numerous factors may impact the Company's quarterly results including the rate of growth for various products launched in 2003, associated promotional costs, the growth and variable supply price on Wellbutrin XL sold to GlaxoSmithKline (GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) ), and the erosion of revenues related to Legacy and Generic products due to competitive or generic activity. Quarterly product revenue will likely increase throughout the year on a quarter over quarter basis primarily due to anticipated increases in Wellbutrin XL supply prices to GSK. Total revenue and Wellbutrin XL revenue is expected to be within the following ranges:
($ millions)
Previous Full year
Guidance Q1 Q2 Q3 Q4 2004
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Total Revenue
(a) 170 - 200 210 - 250 230 - 275 290 - 345 880 - 1,070
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Wellbutrin XL 20 - 35 30 - 45 40 - 55 60 - 105 160 - 210
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Updated
Guidance
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Total Revenue
(a) 150 - 180 190 - 230 220 - 255 240 - 300 800 - 940
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Wellbutrin XL 30 - 40 60 - 80 60 - 80 70 - 100 200 - 250
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(a) Does not cross add
Gross margins are forecast to be higher in 2004 than in 2003 and are expected to be in the range of 74% to 78% of product sales revenue on an annual basis, although lower earlier in the year. Research and development spending is forecast to be in the range of $80 million to $100 million, reflecting an expected increase in clinical activity. Amortization expenses for 2004 will likely be in the range of $65 million to $70 million, excluding amortization associated with 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's tax rate is expected to be in the 4% to 6% range. The Company believes that the establishment of an effective U.S. sales and marketing infrastructure is critical to be a leading Specialty Pharmaceutical company competing in the competitive U.S. marketplace. Early new prescription (NRx) and total prescription (TRx) trends in 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: and 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: are tracking well and the Company has made the decision that additional investment to support these products should produce revenue growth over the next few years. In this regard, the Company is revising its previous guidance for selling, general and administrative expenses from $260-290 million to $300-350 million or 31-36% of total revenue. Fully 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 (1) for 2004 are expected to be in the range of $1.35 and $1.70. Quarterly earnings during 2004 will be impacted by the growth of Wellbutrin XL and the increasing supply price that the company receives on higher levels of end market sales by GSK.
Quarterly fully diluted 2004 earnings per share(1)
guidance by quarter is as follows:
2004 Q1 Q2 Q3 Q4 Full Year
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Previous
earnings
per
share(1)
Guidance $0.25-0.35 $0.30-$0.40 $0.50-$0.65 $0.70-$0.80 $2.00-$2.20
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Revised
earnings
per
share(1)
Guidance $0.10-0.20 $0.20-$0.30 $0.40-$0.55 $0.55-$0.65 $1.35-$1.70
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(1) All earnings per share information assumes the Company will
not have or are exclusive of any charges.
For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies. More information on Biovail Corporation can be found on http://www.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. |
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