EX-99.1 2 a2136984zex-99_1.htm EXHIBIT 99.1

Exhibit 99.1

First Quarter
Report 2004

Biovail
Corporation

Q1


1    BIOVAIL 2004 FIRST QUARTER REPORT

Letter to
Shareholders

[PHOTO]

Dear Fellow Shareholders,

The first quarter of 2004 was very important for Biovail. It gave us an opportunity to demonstrate that Biovail's commercial operations are executing its strategies well and that the Company is meeting its objectives for 2004. Biovail realized U.S. GAAP earnings per share (EPS) of $0.13 for the first quarter of 2004. Our solid execution in the first quarter was highlighted by the completion of the realignment and optimization of our U.S. sales operations; the initial recruitment and deployment of our new specialty sales representatives; the filing of a New Drug Application (NDA) for Ralivia ER, our once-daily formulation of tramadol; and the submission of an NDA for Ralivia FlashDose, our orally disintegrating tramadol product. Early in the second quarter, we also submitted an NDA for Glumetza, a metformin product used in the treatment of Type II diabetes.

PRODUCT SALES PERFORMANCE

Biovail's product sales in the first quarter of 2004 increased 38% to $175 million, compared to $127 million in the first quarter of 2003. Importantly, product sales represented 94% of our total revenue, compared to just 66% in the same period one year ago. This increase in product revenue reflects the successful launches of Cardizem LA, Wellbutrin XL, Teveten HCT and Zovirax Cream in 2003.

CORE PRODUCTS

In an effort to provide greater clarity and understanding of our business strategy and financial performance, we have added a sub-total line item, Core Products, to our product revenue reporting format. This category includes Biovail's U.S. promoted products, Wellbutrin XL and Biovail Pharmaceuticals Canada. Going forward, this category will include all products actively promoted by Biovail, in addition to any new products developed and out-licensed by Biovail for commercialization. Core products generated revenue of $112 million in the first quarter of 2004, representing growth of 100% over the first quarter of 2003.

Wellbutrin XL continues to be a tremendous success story and remains one of the most successful launches in pharmaceutical industry history. Total prescriptions grew by 89% in the first three months of 2004 relative to the fourth quarter of 2003. Wellbutrin XL captured 39% of all bupropion prescriptions (one of the fastest conversion rates in history) and 4.9% of the total antidepressant market in the first quarter of 2004. Biovail's Wellbutrin XL revenues in the first quarter of 2004 were $42 million.


BIOVAIL 2004 FIRST QUARTER REPORT    2

REGULATORY HIGHLIGHTS

Biovail's filing of the NDA for Ralivia ER, in addition to the submission of an NDA for Ralivia FlashDose, position the Company to successfully compete in the $13.9 billion U.S. pain market. In 2003, 16.8 million prescriptions were generated for tramadol products, a 9% increase relative to the prior year. Biovail's 500 mg and 1000 mg Glumetza NDA submission made in conjunction with our development partner, Depomed Inc., will also position us to compete in the metformin market. In 2003, metformin products in the U.S. generated sales of $1.7 billion and prescriptions of 43 million grew 9% relative to 2002.

In addition to these three NDAs, we anticipate two or more regulatory submissions in 2004, a clear indication of the depth of our rapidly maturing development pipeline. This is an ambitious undertaking, given that, over the last ten years, the U.S. Food and Drug Administration (FDA) has received an average of only 117 NDA filings annually from the entire pharmaceutical industry.

Also in April 2004, Cardizem LA received FDA approval for the treatment of angina. This condition currently affects 6.4 million people in the U.S., with approximately 400,000 new cases diagnosed each year.

OPERATIONS

The last twelve months have seen significant investment in Biovail's U.S. infrastructure as we consolidated our sales and marketing groups with select R&D functions in Bridgewater, NJ. The $216 billion U.S. pharmaceutical market represents an attractive opportunity for the Company and investments will continue to be made throughout 2004.

The realignment and optimization of our U.S. sales force is now complete. Our newly optimized primary care sales force of 475 representatives will detail Cardizem LA, Teveten, Teveten HCT, Zovirax Ointment and Zovirax Cream to general practitioners across the U.S.

We have made excellent progress in the recruitment and deployment of our two new specialty sales forces, which will consist of 63 representatives each. One specialty sales force will detail our key cardiovascular products — Cardizem LA, Teveten and Teveten HCT — to cardiologists and nephrologists; while the other will promote Zovirax Ointment and Zovirax Cream to dermatologists and Obstetricians/Gynecologists across the U.S. These medical specialists and key opinion leaders can greatly influence the prescribing patterns of primary care physicians. They also represent a new target audience for Biovail. We are confident that these sales force initiatives will drive continued growth in our promoted products.

Given the increasing demand for our products and especially Wellbutrin XL, Biovail is continuing to expand its manufacturing operations. The Steinbach manufacturing facility now has 510 employees — up from 360 a year ago — and has moved to 24/7 operations to produce 1.7 billion units per year — more than double the 670 million units produced a year ago. This is an incredible level of productivity and essential to meet the Company's growing demands.


3    BIOVAIL 2004 FIRST QUARTER REPORT

NET INCOME

First quarter 2004 net income in accordance with U.S. Generally Accepted Accounting Principles (GAAP) was $21 million as compared to first quarter 2003 net income of $58 million. U.S. GAAP Earnings Per Share (EPS) in first quarter 2004 were $0.13 versus $0.36 in the corresponding period in 2003.

First quarter 2004 U.S. GAAP EPS included a $8.6 million acquired Research & Development charge (which negatively impacted earnings by $0.05 per diluted share) associated with the previously announced acquisition of the remaining interest in BNC-PHARMAPASS.

FUTURE PRODUCTS

Biovail's development pipeline is currently the deepest in the Company's history. Beyond the NDAs already announced in 2004, ongoing development efforts include novel formulations of acyclovir, Teveten, Vasotec, zolpidem, bupropion, venlafaxine and sumatriptan.

LOOKING AHEAD

The investments made in 2003, along with ongoing investments in key areas such as U.S. sales operations and R&D, are having a positive impact on the Company's performance thus far in 2004. Biovail's strategy for the remainder of the year remains the same: executing against our corporate objectives and financial guidance, continuing to make strategic investments to be competitive in the U.S. market, ensuring strong cash flow generation and, ultimately, demonstrating to investors that their confidence in Biovail is well placed.

        On behalf of the Board of Directors of Biovail, I would like to sincerely thank all employees for their ongoing dedication and commitment and our shareholders for their continued support of the Company.

GRAPHIC

Eugene N. Melnyk
Chairman of the Board
Chief Executive Officer


BIOVAIL 2004 FIRST 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)

 
  March 31
  December 31
 
 
  2004
  2003
 
ASSETS              

Current

 

 

 

 

 

 

 
Cash and cash equivalents   $ 67,949   $ 133,261  
Accounts receivable     151,879     179,374  
Inventories     88,921     84,058  
Deposits and prepaid expenses     10,925     15,759  
   
 
 
      319,674     412,452  
Long-term investments     116,807     113,546  
Property, plant and equipment, net     175,633     173,804  
Goodwill, net     100,814     100,814  
Intangible assets, net     1,032,571     1,049,475  
Other assets, net     78,572     72,683  
   
 
 
    $ 1,824,071   $ 1,922,774  
   
 
 

LIABILITIES

 

 

 

 

 

 

 

Current

 

 

 

 

 

 

 
Accounts payable   $ 44,744   $ 67,932  
Accrued liabilities     114,584     105,201  
Minority interest         679  
Income taxes payable     24,332     24,175  
Deferred revenue     6,064     5,765  
Current portion of long-term obligations     37,496     58,816  
   
 
 
      227,220     262,568  
Deferred revenue     13,650     14,500  
Long-term obligations     675,910     764,111  
   
 
 
      916,780     1,041,179  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares     1,451,965     1,448,353  
Stock options outstanding     2,150     2,290  
Deficit     (586,572 )   (607,678 )
Accumulated other comprehensive income     39,748     38,630  
   
 
 
      907,291     881,595  
   
 
 
    $ 1,824,071   $ 1,922,774  
   
 
 

5    BIOVAIL 2004 FIRST QUARTER REPORT

Consolidated Statements of Income
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 March 31
 
 
  2004
  2003
 
 
   
  (Restated [1])

 
REVENUE              
Product sales   $ 175,097   $ 126,914  
Research and development     4,216     2,600  
Co-promotion, royalty and licensing     7,313     61,876  
   
 
 
      186,626     191,390  
   
 
 

EXPENSES

 

 

 

 

 

 

 
Cost of goods sold     52,141     37,412  
Research and development     17,991     18,006  
Selling, general and administrative     59,458     46,708  
Amortization     17,105     40,521  
Acquired research and development     8,640      
Settlements         (24,755 )
   
 
 
      155,335     117,892  
   
 
 
Operating income     31,291     73,498  
Interest income     404     3,067  
Interest expense     (11,394 )   (9,982 )
Foreign exchange gain (loss)     962     (4,841 )
Other income     1,143     507  
   
 
 
Income before provision for income taxes     22,406     62,249  
Provision for income taxes     1,300     4,650  
   
 
 
Net income   $ 21,106   $ 57,599  
   
 
 

Earnings per share

 

 

 

 

 

 

 
Basic   $ 0.13   $ 0.36  
   
 
 
Diluted   $ 0.13   $ 0.36  
   
 
 

Weighted average number of common shares outstanding (000s)

 

 

 

 

 

 

 
Basic     159,002     158,197  
   
 
 
Diluted     159,281     159,493  
   
 
 

BIOVAIL 2004 FIRST QUARTER REPORT    6

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)

 
  Three Months Ended March 31
 
 
  2004
  2003
 
 
   
  (Restated [1])

 
CASH FLOWS FROM OPERATING ACTIVITIES              
Net income   $ 21,106   $ 57,599  

Add (deduct) items not involving cash

 

 

 

 

 

 

 
Depreciation and amortization     22,594     44,174  
Amortization of deferred financing costs     1,887     684  
Amortization of discounts on long-term obligations     941     2,090  
Acquired research and development     8,640      
Other     (2,965 )   4,207  
   
 
 
      52,203     108,754  
Net change in non-cash operating items     11,636     (4,952 )
   
 
 
Cash provided by operating activities     63,839     103,802  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Additions to property, plant and equipment     (8,053 )   (8,368 )
Acquisition of business, net of cash acquired     (9,319 )    
   
 
 
Cash used in investing activities     (17,372 )   (8,368 )
   
 
 

CASH FLOWS FROM FINANCING ACTIVITIES

 

 

 

 

 

 

 
Issuance of common shares, net of issue costs     3,612     1,689  
Repayments under revolving term credit facility, including financing costs     (82,250 )   (100,000 )
Repayments of other long-term obligations     (33,095 )   (40,000 )
   
 
 
Cash used in financing activities     (111,733 )   (138,311 )
   
 
 
Effect of exchange rate changes on cash and cash equivalents     (46 )   22  
   
 
 
Decrease in cash and cash equivalents     (65,312 )   (42,855 )
Cash and cash equivalents, beginning of period     133,261     56,080  
   
 
 
Cash and cash equivalents, end of period   $ 67,949   $ 13,225  
   
 
 

[1]    Financial results for the three months ended March 31, 2003 have been restated for a non-cash foreign exchange translation adjustment of $5,392,000, which resulted in a decrease in net income from $62,991,000 (diluted earnings per share of $0.39) as previously reported to $57,599,000 (diluted earnings per share of $0.36) 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, 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.