EX-99.2 4 a2123764zex-99_2.htm EXHIBIT 99.2
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Exhibit 99.2


Third Quarter Report 2003


Biovail Corporation

[PHOTO]


Q3

GRAPHIC


Letter to
Shareholders

Dear Fellow Shareholders,

Thus far in 2003, we have launched Cardizem® LA, Zovirax Cream and Teveten® HCT, and in September of this year, our partner, GlaxoSmithKline (GSK), launched Wellbutrin XL®, potentially the most important product in the history of Biovail. Many companies several times the size of Biovail would view three or four product launches a monumental task. We have expanded and strengthened our sales force and management team and have achieved early very successful results with these launches, albeit with significant increased investment. We are convinced that this strategic investment and growth of our U.S. infrastructure is in the best long-term interest of the Company, our products and our shareholders.

OUR COMMITMENT

    We will continue to grow by applying our proprietary drug delivery technologies to products with large existing prescription bases in our target therapeutic areas — cardiovascular, central nervous system, pain management, diabetes and other niche areas. As we have done in the past, we will continue to evaluate our pipeline products either for commercialization by our own sales force or for out-licensing.

    Our level of disclosure and transparency has been increased to make our transactions easily understood.

THIRD QUARTER 2003 HIGHLIGHTS

        The most significant event for Biovail during the third quarter of 2003 was the September launch of Wellbutrin XL by our partner GSK. Biovail manufactures this once-daily antidepressant for commercialization in the U.S. by GSK. All early statistics indicate that this is one of the most successful launches in the pharmaceutical industry. Prescription growth in the first eight weeks post launch has been exceptional, and conversion from the twice-daily Wellbutrin SR® to this new once-daily formulation is going extremely well.

        During the third quarter, we entered into a multifaceted transaction with Ethypharm Industries of France, a company with which we have an existing license agreement and a 15% equity interest. Through this new agreement, we appointed Ethypharm our international licensee of Diltiazem LA, an international version of our once-daily Cardizem LA hypertension medication, and sold Ethypharm initial launch quantities of product. Also through this agreement, we bought out the milestone payment and royalty obligation owing to Ethypharm on Tramadol FlashTab, a product they had been developing for us. Clinical trials for this product have been completed and we expect to file it with the U.S. Food and Drug Administration before the end of 2003. Also, subject to certain conditions, we have agreed to invest up to $20 million of convertible debt into Ethypharm.

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        Total revenues for the third quarter of 2003 were $215.3 million, reflecting an increase of 3% over the third quarter of 2002. Net income (U.S. GAAP) for the third quarter was $13.0 million and diluted earnings per share was $0.08 compared to $0.49 for the third quarter of 2002. Excluding certain items, third quarter net income was $34.6 million and diluted earnings per share was $0.22.

NEW REPORTING FORMAT

        We have altered the way we describe our operations and performance using the five categories listed below. We have defined our business in this manner to make our business easier to understand. The first three categories are growth areas and the fourth category offers certain brands that may be exploited in the future.

1.
Core Products — Products actively promoted by Biovail in the U.S., namely Cardizem LA, Zovirax and Teveten®.

2.
Biovail Pharmaceuticals Canada — BPC's current product portfolio includes Tiazac®, Cardizem, Monocor®, Retavase™, Zyban®, Wellbutrin® SR and Celexa (until the end of 2003).

3.
Wellbutrin XL — The magnitude of the impact this product will have on Biovail's revenues suggests that it have its own category.

4.
Legacy Products — These are the non-promoted products from which Biovail continues to derive revenue. As a group, these are declining modestly as expected; however, products such as Ativan® and Vasotec® have large prescription bases and clinical enhancements should allow us to grow these franchises.

5.
Generics — These include controlled release products distributed by Teva Pharmaceuticals.

FINANCIAL GUIDANCE

        In the fourth quarter of this year, we expect product revenue in the range of $225 million to $250 million and total revenue in the range of $250 million to $275 million. We anticipate an increase in research and development spending of 50% over third quarter 2003 levels and increased spending for several key marketing programs in the United States and Canada and the continued strengthening of our marketing infrastructure. Total operating expenses are expected to be in the range of $130 million to $140 million. These expenses reduce earnings in Q4 but position Biovail for stronger performance in 2004. We anticipate earnings per share for Q4 to be in the range of 25 cents to 40 cents.

        For 2004, we estimate total revenue, including revenue from the five categories defined above as well as revenue from R&D and other co-promotions, in the range of $880 million to $1,007 million.

2


IN CLOSING

        The refinements we have made to our disclosure framework for both operations and transactions will serve to create greater clarity and make Biovail's ongoing performance and growth potential easier to understand.

        We have a proven strategy and rich and maturing pipeline of products under development with superb market potential. We anticipate having operating cash flow in excess of $300 million by the end of 2003 and upwards of $400 million by the end of 2004. Our two high-growth products, Cardizem LA and Wellbutrin XL, are producing solid revenue streams. Our pipeline includes two late-stage pipeline products, tramadol XL and metformin XL, and we have added ten developmental product programs to our pipeline in 2003. All of these initiatives and activities clearly represent an exciting future for Biovail.

        On behalf of Biovail's Board of Directors, I would like to thank all our valued employees for their continued dedication to achieving Biovail's objectives, and Biovail's shareholders for their support.

/s/ EUGENE N. MELNYK
Eugene N. Melnyk
Chairman of the Board
Chief Executive Officer

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Consolidated Balance Sheets
In accordance with U.S. generally accepted accounting principles
(All dollar amounts are expressed in thousands of U.S. dollars)

 
  September 30
2003

  December 31
2002

 
 
  (Unaudited)

  (Audited)

 
ASSETS              
Current              
Cash and cash equivalents   $ 43,289   $ 56,080  
Restricted cash     30,060      
Accounts receivable     237,611     190,980  
Inventories     82,563     53,047  
Deposits and prepaid expenses     9,302     21,524  
   
 
 
      402,825     321,631  
Long-term investments     102,035     79,324  
Property, plant and equipment, net     165,551     136,784  
Goodwill, net     102,448     102,212  
Intangible assets, net     1,116,580     1,080,503  
Other assets, net     147,080     113,350  
   
 
 
    $ 2,036,519   $ 1,833,804  
   
 
 

LIABILITIES

 

 

 

 

 

 

 
Current              
Accounts payable   $ 87,806   $ 71,641  
Accrued liabilities     101,749     95,289  
Income taxes payable     44,880     35,691  
Deferred revenue     11,841     19,947  
Current portion of long-term obligations     95,322     122,590  
   
 
 
      341,598     345,158  
Deferred revenue     15,350     18,200  
Minority interest     15,346      
Long-term obligations     701,605     624,760  
   
 
 
      1,073,899     988,118  
   
 
 

SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 
Common shares     1,445,043     1,433,624  
Stock options outstanding     4,940     4,856  
Executive Stock Purchase Plan loans     (9,988 )   (9,988 )
Deficit     (505,449 )   (580,413 )
Accumulated other comprehensive income (loss)     28,074     (2,393 )
   
 
 
      962,620     845,686  
   
 
 
    $ 2,036,519   $ 1,833,804  
   
 
 

4


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 September 30
  Nine Months Ended September 30
 
 
  2003
  2002
  2003
  2002
 
REVENUE                          
Product sales   $ 179,985   $ 174,508   $ 464,629   $ 462,150  
Research and development     4,542     7,653     10,815     19,168  
Co-promotion, royalty and licensing     30,787     26,783     148,543     68,010  
   
 
 
 
 
      215,314     208,944     623,987     549,328  
   
 
 
 
 

EXPENSES

 

 

 

 

 

 

 

 

 

 

 

 

 
Cost of goods sold     40,079     44,007     88,823     121,014  
Research and development     20,608     14,626     60,427     39,547  
Selling, general and administrative     76,733     44,922     179,839     123,240  
Amortization     28,243     15,994     114,650     42,522  
Acquired research and development     18,409         102,609      
Settlements             (34,055 )    
Write-down of assets      —      1,369      —      1,369  
   
 
 
 
 
      184,072     120,918     512,293     327,692  
   
 
 
 
 
Operating income     31,242     88,026     111,694     221,636  
Interest income     1,191     298     5,893     2,859  
Interest expense     (10,540 )   (10,956 )   (30,029 )   (22,753 )
Other income (expense)     (5,958 )   3,309     706     3,243  
   
 
 
 
 
Income before provision for income taxes     15,935     80,677     88,264     204,985  
Provision for income taxes     2,950     5,700     13,300     14,400  
   
 
 
 
 
Net income   $ 12,985   $ 74,977   $ 74,964   $ 190,585  
   
 
 
 
 
Earnings per share                          
Basic   $ 0.08   $ 0.52   $ 0.47   $ 1.27  
   
 
 
 
 
Diluted   $ 0.08   $ 0.49   $ 0.47   $ 1.18  
   
 
 
 
 
Weighted average number of common shares outstanding (000s)                          
Basic     158,704     145,367     158,428     150,252  
   
 
 
 
 
Diluted     160,426     154,016     160,115     161,235  
   
 
 
 
 

5


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)

 
  Nine Months Ended September 30
 
 
  2003
  2002
 
CASH FLOWS FROM OPERATING ACTIVITIES              
Net income   $ 74,964   $ 190,585  
Add (deduct) items not involving cash              
Depreciation and amortization     126,645     50,385  
Amortization of deferred financing costs     2,103     2,016  
Amortization of discounts on long-term obligations     5,461     3,928  
Compensation cost for employee stock options     1,262     1,499  
Acquired research and development     102,609      
Write-down of assets      —      1,369  
Other     (1,884 )   (3,243 )
   
 
 
      311,160     246,539  
Net change in non-cash operating items     (67,100 )   (4,638 )
   
 
 
Cash provided by operating activities     244,060     241,901  
   
 
 

CASH FLOWS FROM INVESTING ACTIVITIES

 

 

 

 

 

 

 
Acquisitions of intangible assets     (203,052 )   (373,388 )
Increase in loan receivable     (40,000 )    
Acquisitions of long-term investments     (34,596 )   (85,451 )
Additions to property, plant and equipment     (28,283 )   (39,284 )
Proceeds on disposal of intangible asset     10,000      
   
 
 
Cash used in investing activities     (295,931 )   (498,123 )
   
 
 
CASH FLOWS FROM FINANCING ACTIVITIES              
Issuance of common shares, net of issue costs     11,419     5,528  
Repurchase of common shares      —      (503,100 )
Proceeds from the exercise of warrants      —      112,823  
Advances under revolving term credit facility, including financing costs     114,800     8,795  
Repayments of other long-term obligations     (88,261 )   (41,980 )
Issuance of Senior Subordinated Notes, net of financing costs         384,280  
   
 
 
Cash provided by (used in) financing activities     37,958     (33,654 )
   
 
 
Effect of exchange rate changes on cash and cash equivalents     1,122     36  
   
 
 
Decrease in cash and cash equivalents     (12,791 )   (289,840 )
Cash and cash equivalents, beginning of period     56,080     434,891  
   
 
 
Cash and cash equivalents, end of period   $ 43,289   $ 145,051  
   
 
 

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Shareholder Information   Corporate 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.

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 and logos are trademarks for the company and may be registered in Canada, the United States and certain other jurisdictions: Biovail, Cardizem®, Tiazac®, Wellbutrin®, Wellbutrin XL®, Wellbutrin SR®, Ativan®, Isordil®, Teveten®, Vasotec®, Vaseretic®, CEFORM™, Shearform™, FlashDose®, Instatab™, SportSafe™, DrinkUp™ and Cardisense®.

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. 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 are forward-looking statements. Forward-looking statements include, but are not necessarily limited to risks and uncertainties, including the difficulty of predicting FDA 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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Third Quarter Report 2003
Biovail Corporation
Q3