Exhibit 99.1
Second Quarter
Report 2004
Biovail
Corporation
Q2
1 BIOVAIL 2004 SECOND QUARTER REPORT
Letter to
Shareholders
[PHOTO]
Dear Fellow Shareholders,
In the second quarter of 2004, Biovail Corporation continued to move toward its
long-term goal of becoming a leading, fully integrated specialty pharmaceutical
company with high growth and profit potential.
Biovail has reached the point in its evolution where focusing on improving
operational efficiencies, management information and financial systems is
paramount.
To this end, Biovail recently made several key changes to the composition of its
executive group. The Company has hired Charles Rowland as Senior Vice-President
and Chief Financial Officer, succeeding Brian Crombie, who remains with Biovail
as Senior Vice-President, Strategic Development. Rick Keefer, who has played a
key role in helping to build our U.S. operation, succeeds Kristine Peterson as
Senior Vice-President, Commercial Operations. The company has also hired John
Sebben to become Vice-President, Global Manufacturing.
FINANCIAL PERFORMANCE
Biovail's financial results for the second quarter of 2004 demonstrate that the
Company's commercial operations are executing well against plan.
Total product sales for second quarter 2004 were up 25% year over year to a
record $197.2 million. Product sales for the first half of 2004 were 31% higher
for the corresponding six-month period in 2003. As a percentage of total
corporate revenue, products sales were 96% and 95% in the second quarter and
first half of 2004 respectively, compared to 73% and 70% in the second quarter
and first of half of 2003 respectively. These increases can be attributed to the
ongoing strength of Wellbutrin XL and Cardizem LA.
Net income for the second quarter of 2004 was $44.2 million, compared with a net
loss of $4.9 million for the corresponding period in 2003. For the first half of
2004, net income was $65.3 million, compared with $52.7 million for the
corresponding 2003 period.
Second quarter 2004 U.S. GAAP diluted earnings per share of 28 cents were at the
high end of Biovail's guidance. This compares to a loss of $0.03 in the second
quarter of 2003 and diluted EPS of 13 cents for the first quarter of this year.
BIOVAIL 2004 SECOND QUARTER REPORT 2
PRODUCTS
Since the Wellbutrin XL launch in September 2003 through our marketing partner,
GlaxoSmithKline (GSK), bupropion's share of the anti-depressant market has
expanded by 18.5%. At the end of June 2004, Wellbutrin XL had captured 49.6% of
new prescriptions written for the Wellbutrin brand (including generics). In the
second quarter of 2004, GSK's net sales of Wellbutrin XL exceeded the first-tier
threshold for the first time, thereby increasing Biovail's supply price to the
second tier of the manufacturing and supply agreement.
The collective performance of our promoted brands in the U.S. shows a clear
focus and steady demand throughout the final phases of field sales optimization,
realignment and staffing initiatives.
Cardizem LA continues to achieve weekly prescription volumes and market share
records throughout the second quarter of the year. Total prescriptions were up
8% in the second quarter of 2004 relative to the first quarter of 2004. As such,
Cardizem LA held a 7.4% share of the once-daily diltiazem market in the second
quarter of 2004, compared with 6.8% for the first quarter of 2004. Again, it's
important to note that recent weekly trends are reflecting the early impact of
Biovail's sales and marketing strategies. We expect the efforts of our specialty
sales forces to continue to drive growth for Cardizem LA in the second half of
2004.
In Canada, performance was driven by the strong performance of Wellbutrin SR and
Tiazac. Wellbutrin SR's prescription volume in the second quarter of 2004 was
18.8% higher than for the corresponding period in 2003. Total prescriptions for
Tiazac in the second quarter of 2004 were up 25.5% over the corresponding period
in 2003, making Tiazac the fastest-growing calcium channel blocker in Canada.
REGULATORY HIGHLIGHTS
Biovail continued to build on the momentum it generated during the first quarter
of the year with respect to product development. During the second quarter of
2004, we filed two New Drug Applications with the U.S. Food and Drug
Administration - one for Glumetza with our partner, Depomed and one for a novel
formulation of citalopram for the treatment of depression.
To date in 2004, Biovail has filed four new drug applications for novel
therapeutics with the U.S. Food and Drug Administration, and completed one
New Drug Submission with the Therapeutic Products Directorate (TPD). We
anticipate at least one additional regulatory submission before the end of the
year.
Biovail expects to receive approval from the TPD for Tiazac XC for the treatment
of hypertension in the second half of 2004. Building on the success of Tiazac,
Canada's leading once-daily diltiazem formulation, Tiazac XC features a new
extended-release delivery system designed for bedtime administration, resulting
in improved blood-pressure control during the early morning hours.
3 BIOVAIL 2004 SECOND QUARTER REPORT
OPERATIONS
During the past 18 months, Biovail has focused on making strategic investments
to consolidate our operations in the U.S. The consolidation of our
U.S. commercial operations and select R&D functions at our Bridgewater, N.J.
facility is complete. Our U.S. sales force now has more than 600 sales
professionals. It includes 475 primary-care representatives and two 63-member
sales forces - one for cardiology and one for dermatology and OB-GYNs. Biovail
intends to leverage this important asset to increase our market share in the
second half of 2004.
Activities at Biovail's flagship manufacturing facility in Steinbach, Manitoba,
are running at their highest levels ever. Our transition to 24/7 production and
12-hour shifts is now complete. In Steinbach we now have 570 employees - up from
350 a year ago. We are now capable of producing in excess of 1.7 billion dosage
units per year; more than twice our capacity of 670 million units just a year
ago. Our facilities in Dorado and Carolina, Puerto Rico continue to optimize
their manufacturing operations and continue to provide Biovail's diltiazem
requirements.
LOOKING AHEAD
To date, in 2004, management and employees at Biovail have worked diligently to
provide tangible, measurable signs of progress.
Biovail's development pipeline is currently the deepest in the Company's
history. Beyond the recent regulatory filings in 2004, our formulation
operations in Chantilly, Virginia and Dublin, Ireland continue their development
efforts for novel formulations of several products, including venlafaxine,
bupropion, eprosartan, enalapril, metoprolol, zolpidem and combination products
involving simvastatin.
Our strategy for the second half of the year remains unchanged - to build on the
solid, measurable success realized in the first six months of the year.
[[Image Removed: GRAPHIC]]
Eugene N. Melnyk
Chairman of the Board
Chief Executive Officer
BIOVAIL 2004 SECOND QUARTER REPORT 4
Consolidated Balance Sheets
In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)
June 30 December 31
2004 2003
ASSETS
Current
Cash and cash equivalents $ 51,659 $ 133,261
Accounts receivable 153,643 179,374
Inventories 94,859 84,058
Deposits and prepaid expenses 11,492 15,759
311,653 412,452
Long-term investments 105,055 113,546
Property, plant and equipment, net 174,835 173,804
Goodwill, net 100,814 100,814
Intangible assets, net 1,016,100 1,049,475
Other assets, net 60,730 72,683
$ 1,769,187 $ 1,922,774
LIABILITIES
Current
Accounts payable $ 51,669 $ 67,932
Accrued liabilities 94,259 105,201
Minority interest - 679
Income taxes payable 22,132 24,175
Deferred revenue 5,234 5,765
Current portion of long-term obligations 74,861 58,816
248,155 262,568
Deferred revenue 12,800 14,500
Long-term obligations 569,079 764,111
830,034 1,041,179
SHAREHOLDERS' EQUITY
Common shares 1,452,031 1,448,353
Stock options outstanding 2,150 2,290
Deficit (542,364 ) (607,678 )
Accumulated other comprehensive income 27,336 38,630
939,153 881,595
$ 1,769,187 $ 1,922,774
5 BIOVAIL 2004 SECOND QUARTER REPORT
Consolidated Statements of Income (Loss)
In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars, except per share
data)
(Unaudited)
Three Months Ended June 30 Six Months Ended June 30
2004 2003 2004 2003
(Restated [1]) (Restated [1])
REVENUE
Product sales $ 197,213 $ 157,730 $ 372,310 $ 284,644
Research and development 2,673 3,673 6,889 6,273
Co-promotion, royalty and licensing 6,427 55,880 13,740 117,756
206,313 217,283 392,939 408,673
EXPENSES
Cost of goods sold 59,052 11,332 111,193 48,744
Research and development 15,830 21,813 33,821 39,819
Selling, general and administrative 55,991 55,593 115,449 102,301
Amortization 15,734 45,886 32,839 86,407
Acquired research and development - 84,200 8,640 84,200
Settlements - (9,300 ) - (34,055 )
146,607 209,524 301,942 327,416
Operating income 59,706 7,759 90,997 81,257
Interest income 167 1,635 571 4,702
Interest expense (8,970 ) (9,507 ) (20,364 ) (19,489 )
Foreign exchange loss (1,318 ) (5,284 ) (356 ) (10,125 )
Other income (expense) (3,577 ) 6,157 (2,434 ) 6,664
Income before provision for income taxes 46,008 760 68,414 63,009
Provision for income taxes 1,800 5,700 3,100 10,350
Net income (loss) $ 44,208 $ (4,940 ) $ 65,314 $ 52,659
Earnings (loss) per share
Basic $ 0.28 $ (0.03 ) $ 0.41 $ 0.33
Diluted $ 0.28 $ (0.03 ) $ 0.41 $ 0.33
Weighted average number of common shares
outstanding (000s)
Basic 159,084 158,386 159,043 158,291
Diluted 159,201 158,386 159,241 159,960
BIOVAIL 2004 SECOND QUARTER REPORT 4
Consolidated Statements of Cash Flows
In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)
(Unaudited)
Six Months Ended June 30
2004 2003
(Restated [1])
CASH FLOWS FROM OPERATING ACTIVITIES
Net income $ 65,314 $ 52,659
Add (deduct) items not involving cash
Depreciation and amortization 44,009 94,355
Amortization of deferred financing costs 2,699 1,369
Amortization of discounts on long-term obligations 1,526 3,978
Acquired research and development 8,640 84,200
Other (401 ) 2,477
121,787 239,038
Net change in non-cash operating items (14,127 ) (64,847 )
Cash provided by operating activities 107,660 174,191
CASH FLOWS FROM INVESTING ACTIVITIES
Additions to property, plant and equipment (14,155 ) (16,572 )
Acquisition of business, net of cash acquired (9,319 ) -
Acquisitions of long-term investments (245 ) (4,536 )
Acquisitions of intangible assets - (196,052 )
Increase in loan receivable - (5,000 )
Proceeds on disposal of intangible asset - 10,000
Cash used in investing activities (23,719 ) (212,160 )
CASH FLOWS FROM FINANCING ACTIVITIES
Advances (repayments) under revolving term credit facility,
including financing costs (122,550 ) 144,000
Repayments of other long-term obligations (52,796 ) (70,386 )
Proceeds on termination of interest rate swaps 6,300 -
Issuance of common shares, net of issue costs 3,678 10,332
Cash provided by (used in) financing activities (165,368 ) 83,946
Effect of exchange rate changes on cash and cash equivalents (175 ) 535
Net increase (decrease) in cash and cash equivalents (81,602 ) 46,512
Cash and cash equivalents, beginning of period 133,261 56,080
Cash and cash equivalents, end of period $ 51,659 $ 102,592
[1] As disclosed in Biovail Corporation's amended Form 6-K for the quarterly
period ended June 30, 2003, financial results for the three months and six
months ended June 30, 2003 have been restated for non-cash foreign exchange
translation adjustments of $3,928,000 and $9,320,000, respectively, which
resulted in an increase in the net loss for the three months ended June 30, 2003
from $1,012,000 (basic and diluted loss per share of $0.01) as previously
reported to $4,940,000 (basic and diluted loss per share of $0.03) as restated,
and a decrease in net income for the six months ended June 30, 2003 from
$61,979,000 (basic and diluted earnings per share of $0.39) as previously
reported to $52,659,000 (basic and diluted earnings per share of $0.33) as
restated. Current and prior years' figures reflect the reclassification of
foreign exchange gains and losses from selling, general and administrative
expenses.
Shareholder Information
BIOVAIL CORPORATION
7150 Mississauga Road
Mississauga, Ontario
Canada L5N 8M5
T: (905) 286-3000
F: (905) 286-3050
E: ir@biovail.com
W: www.biovail.com
HOW TO REACH US FOR MORE INFORMATION
For additional copies of this report, the annual report on Form 20-F as filed
with the United States Securities and Exchange Commission, for quarterly reports
or for further information, please contact Investor Relations.
Corporate Information
TRADING SYMBOL - BVF
New York Stock Exchange
Toronto Stock Exchange
REGISTRARS AND TRANSFER AGENTS
CIBC Mellon Trust Company
Toronto, Ontario, Canada
Mellon Investor Services, LLC
New York, New York, USA
The following words are trademarks of the Company and may be registered in
Canada, the United States and certain other jurisdictions: Ativan, Attenade(tm),
Biovail, Cardizem, CEFORM(tm), Fastab(tm), FlashDose, Glumetza(tm), Isordil,
Ralivia(tm), Shearform(tm), Smartcoat(tm), Tiazac, Teveten, Vasotec and
Vaseretic. Wellbutrin, Wellbutrin SR, Wellbutrin XL(tm), Zovirax, and Zyban are
trademarks of "The GlaxoSmithKline Group of Companies" and are used by the
Company under license.
All other trademarks mentioned in this report, which are not the property of the
Company, are owned by their respective holders and may be licensed to the
Company for use in certain markets.
To the extent any statements made in this report contain information that is not
historical, these statements are essentially forward-looking. As such, they are
subject to risks and uncertainties, including the difficulty in predicting FDA
and TPD 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, the
regulatory environment, legislative amendments and / or changes, fluctuations in
operating results and other risks detailed from time to time in the Company's
filings with the U.S. Securities and Exchange Commission and Canadian securities
authorities.
Financial Statements prepared in accordance with Canadian Generally Accepted
Accounting Principles are made available to all shareholders.
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