Printer Friendly
The Free Library
5,665,269 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Biovail Reports Third-Quarter 2005 Financial Results.


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):

--Total Revenues Up 21% to $258 Million;

--Cash Flows From Operations of $122 Million;

--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 $0.64;

--Company Reaches Third Tier of Supply Price for 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(R);

--Increasing 2005 EPS, 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
 Guidance

Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced financial results for the three-month and nine-month periods ending September 30, 2005.

Total revenues for the three months ended September 30, 2005 were $258.1 million, compared with $213.6 million for the third quarter of 2004, an increase of 21%. Total revenues for the nine months ended September 30, 2005 were $647.9 million, compared with $603.8 million for the first nine months of 2004, an increase of 7%. Third-quarter 2005 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 GAAP

See: Generally Accepted Accounting Principles


GAAP

See generally accepted accounting principles (GAAP).
), was $101.7 million, compared with $49.6 million for the corresponding 2004 period. For the nine months ended September 30, 2005, net income was $116.5 million, compared with $114.9 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 third quarter of 2005 were $0.64, versus $0.31 for the third quarter of 2004. In the first nine months of 2005, GAAP EPS were $0.73, versus EPS of $0.72 for the first nine months of 2004.

GAAP net income and EPS figures for the third quarter of 2005 were negatively impacted by an additional 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.
 related to the 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 group, and a write-down Write-Down

Reducing the book value of an asset because it is overvalued compared to the market value.

Notes:
This is usually reflected in the company's income statement as an expense, thereby reducing net income.
 of assets held for disposal. These charges negatively impacted net income by $7.2 million and EPS by $0.05 in the third quarter of 2005. GAAP net income and EPS figures for the first nine months of 2005 were impacted by a restructuring charge, a non-cash write-down of assets and the write-off Write-Off

A reduction in the value of an asset or earnings by the amount of an expense or loss. Companies are able to write off certain expenses that are required to run the business, or have been incurred in the operation of the business and detract from retained revenues.
 of inventory related to the transaction with Kos Pharmaceuticals, Inc. in May 2005. These items negatively impacted 2005 GAAP net income and EPS by $57.3 million and $0.36, respectively. In the first nine months of 2004, an $8.6-million acquired research-and-development charge associated with the acquisition of the remaining interest in BNC-PHARMAPASS negatively impacted 2004 EPS by $0.05.

"Biovail's record financial performance in the third quarter was complemented by continued execution on the research-and-development front," said Biovail Chief Executive Officer Dr. Douglas Squires. "With 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 and the ideal marketing partner for our once-daily tramadol tramadol /tra·ma·dol/ (tram´ah-dol?) an opioid analgesic used as the hydrochloride salt for the treatment of pain following surgical procedures and oral surgery.

tramadol

an opioid partial µ agonist.
 formulation formulation /for·mu·la·tion/ (for?mu-la´shun) the act or product of formulating.

American Law Institute Formulation
 now in place, Biovail anticipates the commercial launch of this innovative product to the U.S. analgesia analgesia /an·al·ge·sia/ (an?al-je´ze-ah)
1. absence of sensibility to pain.

2. the relief of pain without loss of consciousness.
 market in early 2006. With robust cash flows and a strong balance sheet, we remain well positioned to execute our long-term Long-term

Three or more years. In the context of accounting, more than 1 year.


long-term

1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term.
 growth strategy."

Strategic Alliance for Tramadol

Last week, Biovail announced that it had entered into a supply agreement with Ortho-McNeil, Inc., a Johnson & Johnson company, for the marketing and distribution of Biovail's once-daily, extended-release extended-release /ex·tend·ed-re·lease/ (ek-stend´ed-re-les´) allowing a twofold or greater reduction in frequency of administration of a drug in comparison with the frequency required by a conventional dosage form.  formulation and an orally disintegrating, immediate-release formulation of tramadol hydrochloride tramadol hydrochloride Warning - High-alert drug!

Dromadol (UK), Larapam (UK), Mabron (UK), Tramake (UK), Ultram, Ultram ER, Zamadol (UK), Zydol (UK)

Pharmacologic class: Opioid agonist
 in the United States and 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. . Under the agreement, which has a 10-year term, Biovail will manufacture and supply the products, which will be known as Ultram(R) ER and Ultram(R) ODT See SCO Open Desktop.

ODT - Open Desktop
 (subject to regulatory approval), to Ortho-McNeil for distribution at contractually determined prices, which will be based on Ortho-McNeil's net selling price. For more details, see press release issued November 3, 2005, Biovail Enters Into Commercial Alliance for Tramadol Products.

Third-Quarter 2005 Financial Performance

Product revenues for the third quarter of 2005 were $244.5 million, compared with $202.2 million in the third quarter of 2004, a 21% increase that reflects the strong performance of Wellbutrin XL, 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:
 and Biovail's generics portfolio; partially offset by declines in 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 Legacy products, as well as Teveten Tev·e·ten

A trademark for the drug eprosartan mesylate.


eprosartan mesylate

Teveten

Pharmacologic class: Angiotensin II receptor antagonist

Therapeutic class:
 revenues following the May 2005 transaction with Kos. Product revenues for the nine months ended September 30, 2005 were $609.5 million compared with $572.6 million for the nine months ended September 30, 2004.

Product revenues for Wellbutrin XL(R) were $109.3 million in the third quarter of 2005, and $216.5 million in the first nine months of 2005, compared with $86.4 million and $207.6 million in corresponding periods in 2004, respectively. In the third quarter of 2005, Biovail entered into the third and highest tier of the tiered-pricing agreement with GSK GSK GlaxoSmithKline plc (pharmaceutical company)
GSK Glycogen Synthase Kinase
GSK Gruppentraining Sozialer Kompetenzen (Germany)
GSK Greenland Shark (FAO fish species code) 
. In September 2005, Wellbutrin XL(R) captured 57.9% of the new prescriptions written for the Wellbutrin brand (including generics).

Revenues for Biovail's Zovirax franchise were $22.8 million in the third quarter of 2005, and $68.2 million in the first nine months of 2005, representing increases of 134% and 53%, respectively, when compared with $9.7 million and $44.7 million in the prior-year periods. Revenues for Zovirax in 2004 were impacted by a reduction in wholesaler inventory levels. Total prescription volume for the Zovirax franchise increased 2% in the third quarter of 2005 compared with the third quarter of 2004. In the third quarter of 2005, Zovirax 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 Cream held a combined 69.3% share of the topical topical /top·i·cal/ (top´i-k'l) pertaining to a particular area, as a topical antiinfective applied to a certain area of the skin and affecting only the area to which it is applied.

top·i·cal
adj.
 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 3.6 percentage points in market share versus third-quarter 2004 levels.

Third-quarter 2005 revenues for Biovail Pharmaceuticals Canada (BPC) were $23.4 million, compared with $25.4 million in the prior year period. BPC revenues for the first nine months of 2005 were $72.1 million, compared with $72.2 million in the first nine months of 2004. The key performance driver for BPC was the Tiazac Tiazac® Diltiazem, see there (R) line (including Tiazac(R) XC), where total prescription volume increased 15% in both the third quarter and first nine months of 2005, relative to the corresponding periods in 2004. Launched in January 2005, Tiazac(R) XC continues to perform ahead of expectations. Total prescription volume for Wellbutrin(R) SR decreased 28% in the third quarter of 2005, versus the comparable 2004 period, as a result of the availability of a generic formulation. Monocor revenues, one of BPC's hypertension hypertension or high blood pressure, elevated blood pressure resulting from an increase in the amount of blood pumped by the heart or from increased resistance to the flow of blood through the small arterial blood vessels (arterioles).  products, were also down as a result of a backorder situation, which Biovail believes has been resolved, that persisted through much of the third quarter of 2005.

Subsequent to the end of the third quarter, the 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.
 between RhoxalPharma Inc. and Biovail concluded with a decision in RhoxalPharma's favour. This event does not impact Biovail's ongoing conversion strategy for Tiazac(R) XC.

In the third quarter of 2005, 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,
(R) LA generated revenues of $17.3 million, compared with $5.2 million for the corresponding period in 2004. In the first nine months of 2005, Cardizem(R) LA generated revenues of $46.3 million, compared with $43.3 million in the first nine months of 2004. Biovail now manufactures and supplies Cardizem(R) LA to Kos at contractually determined prices that are in excess of 30% of their net selling prices. The amortization of deferred revenues associated with the Kos transaction positively impacted Cardizem(R) LA revenues by $3.8 million and $6.3 million in the third quarter and first nine months of 2005, respectively.

The Teveten line, divested in May 2005 to Kos, generated revenues of $6.5 million in the first nine months of 2005, compared with $12.4 million in the prior-year period. Biovail no longer has an economic interest in Teveten.

Biovail's legacy products generated revenues of $29.5 million for the third quarter of 2005, compared with $31.9 million in the third quarter of 2004, representing a decrease of 7%. In the first nine months of 2005, legacy products generated revenues of $98.4 million, compared with $85.9 million in the first nine months of 2004, an increase of 15%. This performance is largely attributable to the normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record.  of wholesaler buying levels in 2005 that were impacted by a reduction of inventories in 2004. Partially offsetting factors include the expected year-over-year declines in total prescription volumes for these mature products, and the termination of the sub-licensing agreement for Cedax Ce·dax

A trademark for the drug ceftibuten.


ceftibuten

Cedax

Pharmacologic class: Third-generation cephalosporin

Therapeutic class: Anti-infective

 in August 2004. Biovail continues to evaluate options to enhance the value of its legacy products portfolio and anticipates commenting further in this regard in the near future.

Product revenue for Biovail's portfolio of generic products (distributed by a subsidiary of Teva Pharmaceutical Industries Teva Pharmaceutical Industries Ltd. (Hebrew: טבע תעשיות פרמצבטיות בע"מ), NASDAQ: TEVA is an international pharmaceutical company headquartered in  Ltd.) was $42.3 million in the third quarter of 2005, compared with $38.4 million in the third quarter of 2004. The 10% increase is largely attributable to strong revenues for generic Procardia Pro·car·di·a

A trademark for the drug nifedipine.


nifedipine

Adalat CC, Adalat PA (CA), Adalat XL (CA), Adipine (UK), Afeditab CR, Angiopine (UK), Apo-Nifed (CA), Calchan (UK), Cardilate MR (UK), Cordacten (UK),
 XL. First nine months 2005 revenues were $101.5 million, compared with $106.6 million in the prior-year period. The 5% decrease reflects weaker sales of generic Adalat Ad·a·lat

A trademark for the drug nifedipine.
 CC in the first nine months of 2005.

In 2004, pharmaceutical wholesalers in the U.S. underwent a significant change in their business models, adopting a fee-for-service model that resulted in a reduction in the level of inventories they hold. This industry change impacted Biovail's product revenues in 2004, resulting in inconsistencies between reported revenues and prescription volume. In late 2004 and early 2005, Biovail entered into distribution service agreements (DSAs) with its three major U.S. wholesalers.

Performance Summary

The following table summarizes Biovail's product revenue performance in the third quarter and first nine months (YTD See Year-to-date.

YTD

See year to date (YTD).
) of 2005:
----------------------------------------------------------------------
($000s)       Q3/05     Q3/04   Change    YTD/05     YTD/04    Change
             Revenues  Revenues    (%)   Revenues    Revenues     (%)
----------------------------------------------------------------------
Wellbutrin
 XL(R)        109,261    86,423     26     216,486     207,583      4
Zovirax(R)     22,770     9,747    134      68,175      44,664     53
Biovail
 Pharmaceut-
 icals
 Canada        23,354    25,350     (8)     72,076      72,192     (0)
Cardizem(R)
 LA            17,292     5,243    230      46,271      43,301      7
Legacy
 Products      29,517    31,856     (7)     98,441      85,916     15
Generics       42,261    38,363     10     101,522     106,571     (5)
Teveten             -     5,261   (100)      6,534      12,377    (47)
----------------------------------------------------------------------
Total
 Product
 Revenues     244,455   202,243     21     609,505     572,604      6
----------------------------------------------------------------------


The following table summarizes total prescription volume in the third quarter and first nine months (YTD) of 2005:
----------------------------------------------------------------------
              Q3/05     Q3/04   Change    YTD/05      YTD/04   Change
             Total Rx  Total Rx    (%)   Total Rx    Total Rx     (%)
----------------------------------------------------------------------
Wellbutrin
 XL(R)      3,109,939 2,568,574     21   9,044,081   6,639,381     36
Zovirax(R)    318,183   312,652      2   1,016,565     991,088      3
Biovail
 Pharmaceut-
 icals
 Canada       597,381   790,045    (24)  2,095,961   2,334,613    (10)
Cardizem(R)
 LA           431,667   365,877     18   1,266,447   1,037,702     22
Legacy
 Products     852,354 1,010,733    (16)  2,639,468   3,226,780    (18)
Generics    2,021,821 1,994,724      1   6,039,252   6,088,874     (1)
----------------------------------------------------------------------
Total
 Prescrip-
 tions      7,331,345 7,042,605      4  22,101,774  20,318,438      9
----------------------------------------------------------------------

Source: IMS NPA


Research-and-development revenue increased 41% and 74% in the third quarter and first nine months of 2005 to $7.6 million and $21.2 million, respectively, compared with the corresponding periods of 2004. The increases reflect a higher level of clinical research and laboratory testing services provided to external customers by Biovail's Contract Research Division.

Royalty and other revenue was $6.0 million in the third quarter of 2005 and $17.2 million in the first nine months of 2005, compared with $5.9 million and $19.0 million in the corresponding periods in 2004, respectively. The modest increase in the third quarter of 2005 reflects higher royalty income from our economic interest in Tricor, partially offset by a decrease in royalties from branded Tiazac(R) sales.

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 third quarter of 2005 was $52.0 million, compared with $50.1 million in the third quarter of 2004. Gross margins based on product sales were 78.7% and 74.9% in the third quarter and first nine months of 2005, respectively, compared with 75.2% and 72.4% in the third quarter and first nine months of 2004. Excluding the $10.6 million in inventory charges incurred in the second quarter of 2005 (related to Cardizem(R) CD and inventories of Teveten and Cardizem(R) LA not purchased by Kos), gross margins were 76.6% in the first nine months of 2005.

Selling, general and administrative (SG&A) expenses for the third quarter and first nine months of 2005 were $42.4 million and $174.3 million, respectively, compared with $68.3 million in the third quarter of 2004, and $181.5 million in the first nine months of 2004. The decreases reflect Biovail's restructured approach to commercializing products in the U.S., and an associated reduction in headcount in the Company's U.S. commercial operations group.

Research-and-development expenditures were $19.9 million for the third quarter of 2005 and $62.1 million for the first nine months of 2005, compared with $17.0 million and $49.9 million for the corresponding periods in 2004, respectively. These increases reflect increased activity within Biovail's product-development pipeline. In September 2005, Biovail received U.S. Food and Drug Administration (FDA) approval for its once-daily, extended-release formulation of tramadol for the treatment of moderate to moderately severe chronic pain. Last week, Biovail announced a partnership agreement with Ortho-McNeil, a Johnson & Johnson company, for the commercialization of this product, as well as for Biovail's orally disintegrating version of tramadol. The companies anticipate an early 2006 launch for both of these innovative analgesics Analgesics Definition

Analgesics are medicines that relieve pain.
Purpose

Analgesics are those drugs that mainly provide pain relief.
, which will be known as Ultram(R) ER and Ultram(R) ODT, respectively. In other pipeline programs, development efforts continue for Biovail's enhanced absorption formulation of a 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; 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 ) filing is anticipated in the first quarter of 2006. With respect to Wellbutrin XL(R), we anticipate a European regulatory filing by GSK in 2006.

Amortization expense in the third quarter of 2005 was $15.4 million, compared with $16.3 million in the third quarter of 2004, a modest decrease that reflects 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).  of the Teveten products in May 2005. In the first nine months of 2005, amortization expense was $46.8 million, compared with $49.0 million, a decrease that also reflects the final amortization of Biovail's interest in generic omeprazole omeprazole /omep·ra·zole/ (o-mep´ra-zol) an inhibitor of gastric acid secretion used in the treatment of dyspepsia , gastroesophageal reflux disease, disorders of gastric hypersecretion, and peptic ulcer, including that associated with  in the first quarter of 2004.

Specific Items Affecting Operations

In the third quarter of 2005, Biovail recorded an additional $1.1-million restructuring charge related to the May 2005 realignment of the Company's U.S. commercial operations. Also in the third quarter of 2005, Biovail's Board of Directors approved the divestiture of the Company's Nutravail division. As such, 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 Nutravail's net assets Net assets

The difference between total assets on the one hand and current liabilities and noncapitalized long-term liabilities on the other hand.


net assets

See owners' equity.
 was written down to their fair value of $3.0 million, resulting in a $6.1 million non-cash charge Non-Cash Charge

A charge off, made by a company against earnings, that does not require an initial outlay of cash.

Notes:
Non-cash charges are typically against the depreciation, amortization, and depletion accounts on a company's balance sheet.
 in the third quarter of 2005. In the first nine months of 2005, Biovail incurred a $19.7-million restructuring 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 May 2005 realignment. In addition, the disposal of the Teveten line resulted in a $25.8 million write-down of the carrying value of these product rights to reflect their fair value at the date of disposition. Biovail also wrote off a $0.7 million investment in convertible debentures Convertible Debenture

Any type of debenture that can be converted into some other security.

Notes:
For example, a convertible bond can be converted into stock.
 of Procyon Biopharma Inc. following the termination of the Fibrostat licensing agreement. Additionally, $4.9 million of Cardizem(R) LA and Teveten inventory not purchased by Kos was written-off to cost of goods sold in the second quarter of 2005. In the third quarter of 2004, Biovail recorded a $1.5 million gain on the disposal of Cedax. In the first nine months of 2004, Biovail incurred an $8.6-million acquired R&D charge related to the acquisition of the remaining interest in BNC-PHARMAPASS.

Significant items and their effect on U.S. GAAP EPS in the third quarter of 2005 are listed in the following table:
Table 1. Significant Items included in U.S. GAAP earnings
----------------------------------------------------------------------
Dollar amounts expressed in millions of U.S. dollars, except per share
 data
----------------------------------------------------------------------
                              Three Months Ended   Nine Months Ended
                              September 30, 2005   September 30, 2005
----------------------------------------------------------------------
                                      Per diluted          Per diluted
                              Amount      share    Amount     share
                             -----------------------------------------
Restructuring costs             1.1       $0.01     19.7       $0.12
Write-down of Nutravail
 assets                         6.1       $0.04      6.1       $0.04
Write-down of assets              -           -     26.6       $0.17
Write-off of Cardizem(R) LA,
 Teveten inventory                -           -      4.9       $0.03
----------------------------------------------------------------------


Balance Sheet & Cash Flow

During the third quarter of 2005, following FDA approval of Glumetza(TM), Biovail paid $25.0 million to Depomed Inc. At the end of September 2005, Biovail's cash balances were $326.7 million, with no outstanding borrowings under its revolving term credit facility. The Company's debt-to-equity ratio debt-to-equity ratio

The relationship between long-term funds provided by creditors and funds provided by owners. A firm's debt-to-equity ratio is calculated by dividing long-term debt by owners' equity. Both items are shown on the balance sheet.
 was 0.4 at the end of the third quarter of 2005, compared with 0.5 at December 31, 2004.

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 $122.4 million in the third quarter of 2005 and $278.5 million in first nine months of 2005, representing growth of 109% and 66%, respectively, compared with $58.6 million and $167.4 million in the corresponding periods of 2004. Net capital expenditures in the third quarter of 2005 amounted to $12.9 million, compared with $6.0 million in the third quarter of 2004. The increase reflects the ongoing expansion of the Company's Steinbach manufacturing facility, which Biovail expects to complete in 2006.

Increasing 2005 EPS, Cash Flow From Operations Guidance

As a result of the better-than-expected performance in the third quarter of 2005, Biovail is increasing its 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 guidance range from $1.75 to $1.80 to a range of $1.80 to $1.85. In addition, Biovail is increasing its 2005 cash flow from operations range from $300 million to $340 million to $350 million to $380 million, which does not include the $60 million supply prepayment Prepayment

1. The payment of a debt obligation prior to its due date.

2. The excess payment over a scheduled debt repayment amount.

Notes:
1. Examples include deferred expenses such as rent and early loan repayments.

2.
 from Ortho-McNeil. As before, Biovail's 2005 guidance does not include the impact of any potential new-product launches, supply-and-distribution agreements or acquisitions; 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).  or other specific charges, including those referenced in Table 1; nor does it include expenses related to stock-based compensation.

Update of Regulatory Matters

The 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) ) previously advised that it is investigating, among other things, four issues relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 trading in the Company's common shares. These issues include whether insiders of the Company complied with insider reporting requirements in relation to trading in Biovail shares, and whether persons in a special relationship with the Company may have traded in the Company's shares with knowledge of undisclosed material information. The OSC also advised the Company that it is investigating whether certain persons or companies were engaged in transactions that may have resulted in, or contributed to, a misleading appearance of trading activity in the Company's securities during 2003 and 2004, and whether certain registrants (who are past, or present, directors of Biovail) may have been in a conflict of interest in relation to trading of the Company's shares. The OSC has further advised that its investigation includes looking at trading issues, and reporting and disclosure issues in relation to the trading of Biovail common shares in several accounts in which Eugene Melnyk Eugene Melnyk (born May 27, 1959 in Toronto, Ontario) is a Canadian businessman of Ukrainian origin who now resides in Barbados. He is the chairman and chief executive officer of Biovail Corporation.  may have direct or indirect beneficial ownership of, or control or direction over.

The Company cannot predict the outcome or the timing of when this matter may be resolved.

Securities and Exchange Commission

The U.S. Securities and Exchange Commission (SEC) has advised Biovail that it has reviewed the Company's Form 20-F for the fiscal year ended December 31, 2004 and its Form 6-K, filed August 12, 2005, for the fiscal quarter ended June 30, 2005. The SEC limited its review to the financial statements and related disclosures. It has provided comments as a result of this review and has requested certain additional disclosure in Biovail's filings. These matters are subject to interpretation and the SEC review process is not complete. As a result, the ultimate resolution of these comments is uncertain. Resolution of these comments could involve modifications to our previously filed SEC documents. The Company will provide an update when these matters are resolved, and will revise the Form 20-F and Form 6-K as necessary.

Conference Call

Biovail management will host a conference call and Webcast on Friday, November 11, 2005, at 8:30 a.m. EST EST electroshock therapy.

EST
abbr.
electroshock therapy
 for Company executives to discuss 2005 third-quarter earnings. 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. EST P.M. also p.m. or p.m.
abbr.
post meridiem

Usage Note: By definition, 12 a.m.
 on Friday, November 18, 2005, by dialing 416-695-5800 (Toronto and International callers) and 1-800-408-3053 (U.S. and Canada), using access code, 3165231#.

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 Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com.

"Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
" Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995

To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements forward-looking statement

A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections.
 within the meaning of Section 27A of the Securities Act of 1933, as amended a·mend  
v. a·mend·ed, a·mend·ing, a·mends

v.tr.
1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive.

2.
, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will," "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact.
     2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or
 are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting 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, 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. Biovail undertakes no obligation to update or revise any forward-looking statement.
BIOVAIL CORPORATION
              CONDENSED CONSOLIDATED STATEMENTS OF INCOME
    (All dollar amounts are expressed in thousands of U.S. dollars,
                        except per share data)
                              (Unaudited)

                                Three Months Ended  Nine Months Ended
                                   September 30        September 30
                               ------------------- -------------------
                                 2005      2004      2005      2004
                               --------- --------- --------- ---------
REVENUE
Product sales                  $244,455  $202,243  $609,505  $572,604
Research and development          7,647     5,432    21,216    12,162
Royalty and other                 5,956     5,943    17,201    19,040
                               --------- --------- --------- ---------
                                258,058   213,618   647,922   603,806
                               --------- --------- --------- ---------
EXPENSES
Cost of goods sold               51,991    50,111   152,964   158,076
Research and development         19,913    16,979    62,135    49,929
Selling, general and
 administrative                  42,402    68,273   174,263   181,538
Amortization                     15,443    16,262    46,818    48,965
Restructuring costs               1,118         -    19,725         -
Write-down (gain on disposal)
 of assets                            -    (1,471)   26,560    (1,471)
Acquired research and
 development                          -         -         -     8,640
                               --------- --------- --------- ---------
                                130,867   150,154   482,465   445,677
                               --------- --------- --------- ---------
Operating income                127,191    63,464   165,457   158,129
Interest income                   2,386       186     3,676       757
Interest expense                 (9,450)  (10,103)  (27,921)  (30,467)
Foreign exchange loss            (1,462)     (802)   (2,153)   (1,158)
Other expense                      (271)        -      (804)   (2,434)
                               --------- --------- --------- ---------
Income from continuing
 operations before provision
 for income taxes               118,394    52,745   138,255   124,827
Provision for income taxes        9,095     2,100    11,975     5,200
                               --------- --------- --------- ---------
Income from continuing
 operations                     109,299    50,645   126,280   119,627
Loss from discontinued
 operation                       (7,636)   (1,010)   (9,778)   (4,678)
                               --------- --------- --------- ---------
Net income                     $101,663  $ 49,635  $116,502  $114,949
                               --------- --------- --------- ---------
                               --------- --------- --------- ---------

Basic and diluted earnings per
 share
Income from continuing
 operations                    $   0.69  $   0.32  $   0.79  $   0.75
Loss from discontinued
 operation                        (0.05)    (0.01)    (0.06)    (0.03)
                               --------- --------- --------- ---------
Net income                     $   0.64  $   0.31  $   0.73  $   0.72
                               --------- --------- --------- ---------
                               --------- --------- --------- ---------

Weighted average number of
 common shares
 outstanding (000s)
Basic                           159,421   158,801   159,402   159,060
                               --------- --------- --------- ---------
                               --------- --------- --------- ---------
Diluted                         159,583   158,904   159,491   159,227
                               --------- --------- --------- ---------
                               --------- --------- --------- ---------


                          BIOVAIL CORPORATION
                 CONDENSED CONSOLIDATED BALANCE SHEETS
    (All dollar amounts are expressed in thousands of U.S. dollars)
                              (Unaudited)

                                                  At           At
                                             September 30  December 31
                                                 2005         2004
                                             ------------ ------------
ASSETS
Cash and cash equivalents                    $   326,727  $    34,324
Other current assets                             229,657      280,327
Long-term investments                             76,014       68,046
Property, plant and equipment, net               187,678      186,556
Goodwill                                         100,294      100,294
Intangible assets, net                           874,670      978,073
Other assets, net                                117,684       63,440
                                             ------------ ------------
                                             $ 1,912,724  $ 1,711,060
                                             ------------ ------------
                                             ------------ ------------

LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities                          $   206,309  $   190,237
Long-term obligations                            422,648      445,471
Other long-term liabilities                      102,752       21,439
Shareholders' equity                           1,181,015    1,053,913
                                             ------------ ------------
                                             $ 1,912,724  $ 1,711,060
                                             ------------ ------------
                                             ------------ ------------


                          BIOVAIL CORPORATION
            CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    (All dollar amounts are expressed in thousands of U.S. dollars)
                              (Unaudited)

                                                 Nine Months Ended
                                                    September 30
                                             -------------------------
                                                 2005         2004
                                             ------------ ------------
CASH FLOWS FROM OPERATING ACTIVITIES
Net income                                   $   116,502  $   114,949
Adjustments to reconcile net income to cash
 provided by continuing operating activities
Loss from discontinued operation                   3,665        4,678
Depreciation and amortization                     74,984       64,223
Amortization and write-down of deferred
 financing costs                                   2,671        3,510
Amortization of discounts on long-term
 obligations                                       1,929        2,438
Write-down (gain on disposal) of assets           26,560       (1,471)
Write-down of assets of discontinued
 operation                                         6,113            -
Acquired research and development                      -        8,640
Other                                                652         (823)
Changes in operating assets and liabilities       45,413      (28,731)
                                             ------------ ------------
Net cash provided by continuing operating
 activities                                      278,489      167,413
Net cash provided by (used in) continuing
 investing activities                             46,978      (29,374)
Net cash used in continuing financing
 activities                                      (30,495)    (225,359)
Net cash used in discontinued operation           (2,775)      (2,055)
Effect of exchange rate changes on cash and
 cash equivalents                                    206          157
                                             ------------ ------------
Net increase (decrease) in cash and cash
 equivalents                                     292,403      (89,218)
Cash and cash equivalents, beginning of
 period                                           34,324      133,261
                                             ------------ ------------
Cash and cash equivalents, end of period     $   326,727  $    44,043
                                             ------------ ------------
                                             ------------ ------------
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Nov 11, 2005
Words:4404
Previous Article:Cypress's CEO and CFO to Address Upcoming Investor Conferences; Webcasts Available on Cypress Website at: http://www.cypress.com/investors.
Next Article:Volkswagen AG: Supervisory Board appoints Human Resources Director.
Topics:



Related Articles
Capital Senior Living reports revenue increase. (Filings).
Biovail Reports Third Quarter 2004 Financial Results.
Biovail Reports First-Quarter 2005 Financial Results.
Biovail Updates 2005 Guidance; Strategic Transaction With Kos Results in Increased EPS Guidance; Diluted EPS Guidance Range Now $1.70 - $1.75 vs....
Biovail Reports Second-Quarter 2005 Financial Results.
Biovail Announces Third-Quarter 2005 Earnings Release, Conference-Call Details.
Biovail Reports Fourth Quarter, Year-End 2005 Financial Results.
Biovail Reports First-Quarter 2006 Financial Results; Company Records Total Revenues of $220.5 Million; Operating Margins of 35.1%; EPS From...
Biovail Reports Third-Quarter 2006 Financial Results.
Biovail Reports First-Quarter 2007 Financial Results, Plans to File Amended 2006 Form 20-F.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles