-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WUZQ4tVlLgQu9c0UOc9NscX3J6LA9CT1Rix5+dJTFXX/6fjACmu4len0xshA5jbr ia0V9nMq7XBiVZqg8sooig== 0000950137-05-013261.txt : 20051103 0000950137-05-013261.hdr.sgml : 20051103 20051103094657 ACCESSION NUMBER: 0000950137-05-013261 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051103 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051103 DATE AS OF CHANGE: 20051103 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VALEANT PHARMACEUTICALS INTERNATIONAL CENTRAL INDEX KEY: 0000930184 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330628076 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11397 FILM NUMBER: 051175262 BUSINESS ADDRESS: STREET 1: 3300 HYLAND AVE CITY: COSTA MESA STATE: CA ZIP: 92626 BUSINESS PHONE: 7145450100 MAIL ADDRESS: STREET 1: 3300 HYLAND AVE CITY: COSTA MESA STATE: CA ZIP: 92626 FORMER COMPANY: FORMER CONFORMED NAME: ICN PHARMACEUTICALS INC DATE OF NAME CHANGE: 19941114 FORMER COMPANY: FORMER CONFORMED NAME: ICN MERGER CORP DATE OF NAME CHANGE: 19940915 8-K 1 a14119e8vk.htm FORM 8-K Valeant Pharmaceuticals
Table of Contents

 
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of the earliest event reported): November 3, 2005
 
Valeant Pharmaceuticals International
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
  1-11397
(Commission File Number)
  33-0628076
(I.R.S Employer
Identification No.)
3300 Hyland Avenue
Costa Mesa, California 92626

(Address of principal executive offices) (Zip Code)
(714) 545-0100
(Registrant’s telephone number, including area code)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition
Item 9.01 Financial Statements and Exhibits
SIGNATURES
Index to Exhibits
EXHIBIT 99.1


Table of Contents

Item 2.02 Results of Operations and Financial Condition
     On November 3, 2005, Valeant Pharmaceuticals International issued a press release announcing results of operations for the third quarter of 2005 and financial condition as of September 30, 2005. A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by this reference.
     The information in this Item 2.02, including the exhibit attached hereto, will not be treated as filed for the purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section. This information will not be incorporated by reference into any filing under the Securities Act of 1933, or into another filing under the Exchange Act, unless that filing expressly refers to such information.
Item 9.01 Financial Statements and Exhibits
     (c) Exhibits
     
Exhibit Number   Description
99.1
  Press release, dated November 3, 2005.

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Table of Contents

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  VALEANT PHARMACEUTICALS INTERNATIONAL
 
 
Date: November 3, 2005  By:   /s/ Bary G. Bailey    
    Bary G. Bailey   
    Executive Vice President and Chief Financial Officer   

-3-


Table of Contents

         
Index to Exhibits
     
Exhibit Number   Description
99.1
  Press release, dated November 3, 2005.

-4-

EX-99.1 2 a14119exv99w1.htm EXHIBIT 99.1 exv99w1
 

(VALEANT LOGO AND ADDRESS)
 
     
Investor Relations Contact:
Jeff Misakian, Valeant Pharmaceuticals
714-545-0100 ext. 3309
  Media Relations Contact:
Dan Springer, Valeant Pharmaceuticals
714-545-0100 ext. 3381
VALEANT PHARMACEUTICALS REPORTS
THIRD QUARTER 2005 RESULTS
— Revenues Increase 23 Percent; Product Sales Advance 21 Percent —
      
     COSTA MESA, Calif., November 3, 2005 — Valeant Pharmaceuticals International (NYSE: VRX) today announced results for the third quarter of 2005 that reflect double-digit growth in product sales, continued focus on operating expenses and improved operating profitability.
Third Quarter 2005 vs. Third Quarter 2004 Highlights:
    Revenues increased 23 percent to $205.0 million compared to $166.4 million.
 
    Product sales increased 21 percent to $183.0 million compared to $151.1 million.
 
    Ribavirin royalties increased 43 percent to $22.0 million compared to $15.3 million.
 
    Net loss was $3.7 million, or $0.04 per diluted share, compared to a net loss of $15.9 million, or $0.19 per diluted share.
 
    Adjusting for certain non-GAAP items, adjusted income from continuing operations was $6.9 million, or $0.07 per diluted share, compared to $2.4 million, or $0.03 per diluted share.
     A reconciliation of GAAP to non-GAAP results is provided in Tables 2-4.
     Timothy C. Tyson, Valeant’s president and chief executive officer, said, “Our performance in the third quarter was fueled by the growth of our key promoted brands, including strategic products acquired earlier in the year. In particular, the launch of the Diastat(R) AcuDial™ brand generated significant sales and was achieved quickly because of the efforts of our regulatory and marketing teams who worked closely with the FDA. Because of our revenue expansion and continued improvement in metric performance, operating income from our specialty pharmaceutical business was up 17 percent in the quarter and adjusted income from continuing operations was substantially ahead of the prior year.”
Revenues:
     The increase in product sales in the 2005 third quarter was led by the addition and growth of products that were purchased from Xcel Pharmaceuticals in early 2005 and growth in other key promoted brands. Acquired products have become a key component of the company’s promoted

 


 

(VALEANT LOGO)
 
brands and, per the company’s strategic plan, have contributed significantly to growth. Overall, promoted brands grew 55 percent in the 2005 third quarter, primarily due to the addition and growth of products acquired in the Xcel transaction, including Diastat(R) and Migranal(R), and increased sales of other products such as Bedoyecta™ and Kinerase(R). Sales of Xcel products totaled $22.9 million in the 2005 third quarter, 30 percent higher than the $17.5 million in sales recorded by Xcel in the 2004 third quarter.
     The impact of foreign currency translation increased product sales by $6.2 million and operating income by $2.0 million in the 2005 third quarter, compared to the same period last year.
     The increase in ribavirin royalty revenue was primarily due to sales of ribavirin in Japan.
Regional Sales Performance:
     North America product sales increased 65 percent in the 2005 third quarter to $60.5 million compared to $36.6 million in the same period last year. The increase in North America was primarily driven by the addition and growth of acquired products, particularly Diastat and Migranal. Diastat sales were $17.5 million in the 2005 third quarter and reflected higher demand and the launch of the Diastat AcuDial delivery system. Growth of other promoted brands, such as Kinerase and Cesamet™ also contributed to the increase in North America.
     European product sales increased slightly in the 2005 third quarter to $61.7 million, compared to $61.5 million in the same period last year. Foreign currency translation in the European region increased sales by $1.8 million. A number of products in Europe, including Bisocard, Mestinon(R), and Dermatix™ performed well. The pricing environment in Europe continues to be challenging and performance in the quarter was impacted by government-imposed price reductions in many countries.
     Sales in Latin America increased 13 percent to $43.4 million in the 2005 third quarter, compared to $38.5 million in the same period last year. The increase was primarily due to a 90 percent increase in sales of Bedoyecta in the quarter. Foreign currency translation contributed $3.3 million to the Latin American sales increase.
     Sales in the Asia, Australia and Africa (AAA) region increased 20 percent in the 2005 third quarter to $17.4 million, compared to $14.5 million in the same period last year, primarily due to increased sales of regional products such as Nyal™ and Reptilase(R).
Financial Metrics:
     The company’s gross margin on product sales increased for the 2005 third quarter to 70 percent, compared to 67 percent in the same period last year. The improved gross margin primarily reflects increased sales in North America, a favorable mix of higher margin products and the company’s manufacturing improvement efforts. In addition, the company took a $1.1 million charge in its Latin America cost of goods sold for assets that should have been eliminated in 1999 associated with products sold through its Brazilian operations.
     Selling expense as a percent of product sales was 32 percent for the 2005 third quarter, compared to 30 percent in the same period last year. General and administrative expenses were 15

2


 

(VALEANT LOGO)
 
percent of product sales for the 2005 third quarter, compared to 14 percent, adjusted for non-GAAP items, in the same period last year. The increases reflect the company’s expanded neurology business, promotional costs related to increased activity and line extensions for promoted products and investments in infrastructure to support the growth of the company.
     Research and development expenses were 16 percent of product sales for the 2005 third quarter, compared to 17 percent in the same period last year. Research and development costs continue to reflect investments in the company’s late-stage pipeline for the development of Viramidine(R), pradefovir and retigabine.
Balance Sheet Information:
     Cash and marketable securities at September 30, 2005 totaled $385 million, compared to $462 million at December 31, 2004. The reduction of cash was primarily due to the acquisition of Xcel Pharmaceuticals.
Conference Call Information:
     Valeant will host a conference call today at 10:00 a.m. EST (7:00 a.m. PST) to discuss its 2005 third quarter results. The dial-in number to participate on this call is (877) 295-5743, confirmation code 1259446. International callers should dial (706) 679-0845, confirmation code 1259446. The company will also webcast the conference call live over the Internet. The webcast may be accessed through the investor relations section of Valeant’s corporate Web site at www.valeant.com.
About Valeant:
     Valeant Pharmaceuticals International (NYSE: VRX) is a global, publicly traded, research-based specialty pharmaceutical company that discovers, develops, manufactures and markets pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
     Viramidine, Diastat, Diastat AcuDial, Migranal, Kinerase, Mestinon, Bedoyecta, Dermatix, Cesamet, Nyal and Reptilase are trademarks or registered trademarks of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or the registered trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS:
     This press release may contain forward-looking statements that are based on management’s current expectations and involve risks and uncertainties, including, but not limited to, risks and uncertainties relating to projections of future sales, returns on invested assets and clinical development, regulatory approval processes, marketplace acceptance of the company’s products, success of the company’s strategic repositioning initiatives and the ability of management to execute them, cost-cutting measures, success of the company’s strategic plan and the ability to achieve financial targets and cost reduction goals, general economic factors and business and capital market

3


 

(VALEANT LOGO)
 
conditions, general industry trends, changes in tax law requirements and government regulation, adverse events that would require clinical trials to be prematurely terminated, clinical results that indicate continuing clinical and commercial pursuit of product candidates is not advisable, and the fact that Phase 2 clinical trial results are not always indicative of those seen in Phase 3 clinical trials, and other risks detailed from time to time in Valeant’s SEC filings. Valeant wishes to caution the reader that these factors, as well as other factors described in Valeant’s SEC filings, are among the factors that could cause actual results to differ materially from the expectations described in the forward-looking statements. Valeant also cautions the reader that undue reliance should not be placed on any of the forward-looking statements, which speak only as of the date of this release. The company undertakes no responsibility to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
Financial Tables Follow
###

4


 

Table 1
Valeant Pharmaceuticals International
Consolidated Condensed Statement of Income
For the three and nine months ended September 30, 2005 and 2004
                                                 
    Three Months Ended             Nine Months Ended        
    September 30,             September 30,        
    2005     2004     % Change     2005     2004     % Change  
(In thousands, except per share data)
                                               
 
                                               
Product sales
  $ 183,004     $ 151,099       21 %   $ 525,635     $ 431,058       22 %
Ribavirin royalties
    21,953       15,333       43 %     65,494       63,444       3 %
 
                                       
Total revenues
    204,957       166,432       23 %     591,129       494,502       20 %
 
                                       
 
                                               
Cost of goods sold
    55,694       49,264       13 %     157,355       141,914       11 %
Selling expenses
    59,017       45,046       31 %     173,286       146,363       18 %
General and administrative expenses
    26,665       24,962       7 %     77,227       73,686       5 %
Research and development costs
    28,883       25,045       15 %     82,166       64,429       28 %
Acquired in-process research and development (a)
                      126,399       11,770       974 %
Restructuring charges (b)
    135       (69 )     (296 %)     506       20,116       (97 %)
Amortization expense
    15,782       14,094       12 %     46,961       41,514       13 %
 
                                       
 
    186,176       158,342       18 %     663,900       499,792       33 %
 
                                       
Income (loss) from operations
    18,781       8,090               (72,771 )     (5,290 )        
 
                                               
Interest expense, net
    (6,884 )     (7,748 )             (20,494 )     (30,821 )        
Loss on early extinguishment of debt
          (13,994 )                   (19,892 )        
Other expense, net including translation and exchange
    (1,207 )     (515 )             (5,629 )     (2,193 )        
 
                                       
Income (loss) from continuing operations before provision for income taxes and minority interest
    10,690       (14,167 )             (98,894 )     (58,196 )        
 
                                               
Provision (benefit) for income taxes
    15,319       (5,550 )             41,745       (11,831 )        
Minority interest
    184       (81 )             489       8          
 
                                       
Loss from continuing operations
    (4,813 )     (8,536 )             (141,128 )     (46,373 )        
 
                                               
Income (loss) from discontinued operations, net
    1,123       (7,365 )             (2,368 )     (24,392 )        
 
                                       
 
                                               
Net loss
  $ (3,690 )   $ (15,901 )           $ (143,496 )   $ (70,765 )        
 
                                       
 
                                               
Basic earnings per common share
                                               
Loss from continuing operations
  $ (0.05 )   $ (0.10 )           $ (1.54 )   $ (0.55 )        
Discontinued operations, net
    0.01       (0.09 )             (0.03 )     (0.29 )        
 
                                       
Net loss
  $ (0.04 )   $ (0.19 )           $ (1.57 )   $ (0.84 )        
 
                                       
Shares used in per share computation
    92,626       84,055               91,357       83,795          
 
                                       
 
                                               
Diluted earnings per common share
                                               
Loss from continuing operations
  $ (0.05 )   $ (0.10 )           $ (1.54 )   $ (0.55 )        
Discontinued operations, net
    0.01       (0.09 )             (0.03 )     (0.29 )        
 
                                       
Net loss
  $ (0.04 )   $ (0.19 )           $ (1.57 )   $ (0.84 )        
 
                                       
Shares used in per share computation
    92,626       84,055               91,357       83,795          
 
                                       
 
(a)   Expense associated with the write-off of acquired in-process research and development (“IPR&D”) related to the Xcel Pharmaceuticals, Inc. acquisition in 2005 and the Amarin acquisition in 2004.
 
(b)   Restructuring charges related to our manufacturing rationalization plan. In the third quarter of 2005, we sold a manufacturing site and recorded a net gain on the sale of this site.

 


 

Table 2
Valeant Pharmaceuticals International
Consolidated Condensed Statements of Operations and Reconciliation of Non-GAAP Adjustments
                         
    Three Months Ended  
    September 30, 2005  
            Non-GAAP        
    GAAP     Adjustments     Adjusted  
(In thousands, except per share data)
                       
 
                       
Product sales
  $ 183,004     $     $ 183,004  
Ribavirin royalties
    21,953             21,953  
 
                 
Total revenues
    204,957             204,957  
 
                 
 
                       
Cost of goods sold
    55,694             55,694  
Selling expenses
    59,017             59,017  
General and administrative expenses
    26,665             26,665  
Research and development costs
    28,883             28,883  
Restructuring charges
    135       (135 )(a)      
Amortization expense
    15,782             15,782  
 
                 
 
    186,176       (135 )     186,041  
 
                 
Income from operations
    18,781       135       18,916  
 
                       
Interest expense, net
    (6,884 )           (6,884 )
Other expense, net including translation and exchange
    (1,207 )           (1,207 )
 
                 
Income from continuing operations before provision for income taxes and minority interest
    10,690       135       10,825  
 
                       
Provision for income taxes
    15,319       (11,530 )(b)     3,789  
Minority interest
    184             184  
 
                 
Income (loss) from continuing operations
    (4,813 )     11,665       6,852  
 
                       
Income (loss) from discontinued operations, net
    1,123       (1,780 )(c)     (657 )
 
                 
 
                       
Net income (loss)
  $ (3,690 )   $ 9,885     $ 6,195  
 
                 
 
                       
Basic earnings per common share
                       
Income (loss) from continuing operations
  $ (0.05 )           $ 0.07  
Discontinued operations, net
    0.01                
 
                   
Net income (loss)
  $ (0.04 )           $ 0.07  
 
                   
Shares used in per share computation
    92,626               92,626  
 
                   
 
                       
Diluted earnings per common share
                       
Income (loss) from continuing operations
  $ (0.05 )           $ 0.07  
Discontinued operations, net
    0.01                
 
                   
Net income (loss)
  $ (0.04 )           $ 0.07 (d)
 
                   
Shares used in per share computation
    92,626               95,316  
 
                   
 
(a)   Related to net loss on sale of manufacturing sites.
 
(b)   The tax adjustment of $11.5 million includes $5.5 million attributable to tax benefits from U.S. net operating losses (“NOL”) not recognized for GAAP purposes and $3.9 million related to the repatriation of foreign earnings related to the American Jobs Creation Act of 2004.
 
(c)   Net gain on sale of Hungary discontinued operations.
 
(d)   Shares used in adjusted diluted earnings per share (“EPS”) includes the effect of diluted shares which are anti-dilutive to GAAP EPS.
We use certain non-GAAP financial measures, including adjusted net income (loss) from continuing operations and adjusted earnings per share, both of which exclude acquired IPR&D, sales force reduction costs, restructuring costs, impairment charges and various tax issues. We exclude these items in assessing our financial performance, primarily due to their non-operational nature or because they are outside of our normal operations. The non-GAAP financial measures should not be considered as an alternative to, or more meaningful than the GAAP financial measures.

 


 

Table 2.1
Valeant Pharmaceuticals International
Consolidated Condensed Statements of Operations and Reconciliation of Non-GAAP Adjustments
                         
    Three Months Ended  
    September 30, 2004  
            Non-GAAP        
    GAAP     Adjustments     Adjusted  
(In thousands, except per share data)
                       
 
                       
Product sales
    151,099     $     $ 151,099  
Ribavirin royalties
    15,333             15,333  
 
                 
Total revenues
    166,432             166,432  
 
                 
 
                       
Cost of goods sold
    49,264             49,264  
Selling expenses
    45,046       (210 )(a)     44,836  
General and administrative expenses
    24,962       (3,190 )(a),(b)     21,772  
Research and development costs
    25,045             25,045  
Restructuring charges
    (69 )     69 (c)      
Amortization expense
    14,094             14,094  
 
                 
 
    158,342       (3,331 )     155,011  
 
                 
Income from operations
    8,090       3,331       11,421  
 
                       
Interest expense, net
    (7,748 )           (7,748 )
Other expense, net including translation and exchange
    (14,509 )     13,994 (d)     (515 )
 
                 
Income (loss) from continuing operations before provision for income taxes and minority interest
    (14,167 )     17,325       3,158  
 
                       
Provision (benefit) for income taxes
    (5,550 )     6,370 (e)     820  
Minority interest
    (81 )           (81 )
 
                 
Income (loss) from continuing operations
    (8,536 )     10,955       2,419  
 
                       
Loss from discontinued operations, net
    (7,365 )           (7,365 )
 
                 
 
                       
Net loss
  $ (15,901 )   $ 10,955     $ (4,946 )
 
                 
 
                       
Basic earnings per common share
                       
Income (loss) from continuing operations
  $ (0.10 )           $ 0.03  
Discontinued operations, net
    (0.09 )             (0.09 )
 
                   
Net loss
  $ (0.19 )           $ (0.06 )
 
                   
Shares used in per share computation
    84,055               84,055  
 
                   
 
                       
Diluted earnings per common share
                       
Income (loss) from continuing operations
  $ (0.10 )           $ 0.03  
Discontinued operations, net
    (0.09 )             (0.09 )
 
                   
Net loss
  $ (0.19 )           $ (0.06 )
 
                   
Shares used in per share computation
    84,055               86,543 (f)
 
                   
 
(a)   Sales force reduction costs.
 
(b)   Legal expenses related to the settlement of a bondholder class action lawsuit.
 
(c)   Restructuring charges were primarily related to our manufacturing rationalization plan and include impairment charges on manufacturing sites and severance charges.
 
(d)   Loss on early extinguishment of debt.
 
(e)   Tax effect for non-GAAP adjustments.
 
(f)   Shares used in adjusted diluted EPS includes the effect of diluted shares which are anti-dilutive to GAAP EPS.
See non-GAAP financial measure disclosure on Table 2.

 


 

Table 3
Valeant Pharmaceuticals International
Consolidated Condensed Statements of Operations and Reconciliation of Non-GAAP Adjustments
                         
    Nine Months Ended  
    September 30, 2005  
            Non-GAAP        
    GAAP     Adjustments     Adjusted  
In thousands, except per share data
                       
 
                       
Product sales
  $ 525,635     $     $ 525,635  
Ribavirin royalties
    65,494             65,494  
 
                 
Total revenues
    591,129             591,129  
 
                       
Cost of goods sold
    157,355             157,355  
Selling expenses
    173,286             173,286  
General and administrative expenses
    77,227             77,227  
Research and development costs
    82,166             82,166  
Acquired in-process research and development
    126,399       (126,399 )(a)      
Restructuring charges
    506       (506 )(b)      
Amortization expense
    46,961       (1,532 )(c)     45,429  
 
                 
 
    663,900       (128,437 )     535,463  
 
                 
 
                       
Income (loss) from operations
    (72,771 )     128,437       55,666  
 
                       
Interest expense, net
    (20,494 )           (20,494 )
Other expense, net including translation and exchange
    (5,629 )           (5,629 )
 
                 
Income (loss) from continuing operations before provision for income taxes and minority interest
    (98,894 )     128,437       29,543  
 
                       
Provision for income taxes
    41,745       (31,405 )(d)     10,340  
Minority interest
    489             489  
 
                 
Income (loss) from continuing operations
    (141,128 )     159,842       18,714  
 
                       
Loss from discontinued operations, net
    (2,368 )     (1,780 )(e)     (4,148 )
 
                 
 
                       
Net income (loss)
  $ (143,496 )   $ 158,062     $ 14,566  
 
                 
 
                       
Basic earnings per common share
                       
Income (loss) from continuing operations
  $ (1.54 )           $ 0.20  
Discontinued operations, net
    (0.03 )             (0.04 )
 
                   
Net income (loss)
  $ (1.57 )           $ 0.16  
 
                   
Shares used in per share computation
    91,357               91,357  
 
                   
 
                       
Diluted earnings per common share
                       
Income (loss) from continuing operations
  $ (1.54 )           $ 0.20  
Discontinued operations, net
    (0.03 )             (0.04 )
 
                   
Net income (loss)
  $ (1.57 )           $ 0.16  
 
                   
Shares used in per share computation
    91,357               94,612 (f)
 
                   
 
(a)   Expense associated with the write-off of acquired IPR&D related to the Xcel Pharmaceuticals acquisition.
 
(b)   Impairment charge on our manufacturing site in China and net gain on sale of four manufacturing sites.
 
(c)   Impairment charges on products sold in Spain and North America.
 
(d)   The acquired IPR&D charge and the restructuring charge are not deductible for income tax purposes. The tax adjustment of $31.4 million includes $22.2 million relating to our estimate of expenses associated with various tax issues raised by the Internal Revenue Service, $15.7 million attributable to U.S. NOLs not recognized for GAAP purposes and $3.9 million related to the repatriation of foreign earnings related to the American Jobs Creation Act of 2004, partially offset by the reversal of foreign tax valuation allowances.
 
(e)   Net gain on sale of Hungary discontinued operations.
 
(f)   Shares used in adjusted diluted earnings per share (“EPS”) includes the effect of diluted shares which are anti-dilutive to GAAP EPS.
See non-GAAP financial measure disclosure on Table 2.

 


 

Table 3.1
Valeant Pharmaceuticals International
Consolidated Condensed Statements of Operations and Reconciliation of Non-GAAP Adjustments
                         
    Nine Months Ended  
    September 30, 2004  
            Non-GAAP        
    GAAP     Adjustments     Adjusted  
In thousands, except per share data
                       
 
                       
Product sales
  $ 431,058     $     $ 431,058  
Ribavirin royalties
    63,444             63,444  
 
                 
Total revenues
    494,502             494,502  
 
                       
Cost of goods sold
    141,914             141,914  
Selling expenses
    146,363       (3,561 )(a)     142,802  
General and administrative expenses
    73,686       (4,349 )(b)     69,337  
Research and development costs
    64,429             64,429  
Acquired in-process research and development
    11,770       (11,770 )(c)      
Restructuring charges
    20,116       (20,116 )(d)      
Amortization expense
    41,514             41,514  
 
                 
 
    499,792       (39,796 )     459,996  
 
                 
 
                       
Income (loss) from operations
    (5,290 )     39,796       34,506  
 
                       
Interest expense, net
    (30,821 )           (30,821 )
Other expense, net including translation and exchange
    (22,085 )     19,892 (e)     (2,193 )
 
                 
Income (loss) from continuing operations before provision for income taxes and minority interest
    (58,196 )     59,688       1,492  
 
                       
Provision (benefit) for income taxes
    (11,831 )     12,218 (f)     387  
Minority interest
    8             8  
 
                 
Income (loss) from continuing operations
    (46,373 )     47,470       1,097  
 
                       
Loss from discontinued operations, net
    (24,392 )     10,080 (g)     (14,312 )
 
                 
 
                       
Net loss
  $ (70,765 )   $ 57,550     $ (13,215 )
 
                 
 
                       
Basic earnings per common share
                       
Income (loss) from continuing operations
  $ (0.55 )           $ 0.01  
Discontinued operations, net
    (0.29 )             (0.17 )
 
                   
Net loss
  $ (0.84 )           $ (0.16 )
 
                   
Shares used in per share computation
    83,795               83,795  
 
                   
 
                       
Diluted earnings per common share
                       
Income (loss) from continuing operations
  $ (0.55 )           $ 0.01  
Discontinued operations, net
    (0.29 )             (0.16 )
 
                   
Net loss
  $ (0.84 )           $ (0.15 )
 
                   
Shares used in per share computation
    83,795               86,543 (h)
 
                   
 
(a)   Sales force reduction costs.
 
(b)   Legal expenses related to the settlement of the bondholder class action lawsuit.
 
(c)   In-process research and development charge related to the acquisition of Amarin.
 
(d)   Restructuring charges were primarily related to our manufacturing rationalization plan and include impairment charges on manufacturing sites and severance charges.
 
(e)   Loss on early extinguishment of debt.
 
(f)   Tax effect for non-GAAP adjustments.
 
(g)   Environmental reserve, net of tax.
 
(h)   Shares used in adjusted diluted EPS includes the effect of diluted shares which are anti-dilutive to GAAP EPS.
See non-GAAP financial measure disclosure on Table 2.

 


 

Table 4
Valeant Pharmaceuticals International
GAAP reconciliation of basic and diluted earnings per share
For the three and nine months ended September 30, 2005 and 2004
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2005     2004     2005     2004  
(In thousands, except per share data)
                               
 
                               
Loss from continuing operations
  $ (4,813 )   $ (8,536 )   $ (141,128 )   $ (46,373 )
 
                               
Non-GAAP pre-tax adjustments:
                               
Acquired IPR&D
                126,399       11,770  
Sales force reduction costs, net
          175             4,685  
Product impairment charges
                1,532        
Restructuring charges
    135       (69 )     506       20,116  
Loss on early extinguishment of debt
          13,994             19,892  
Settlement of class action lawsuit
          3,225             3,225  
Tax effect on the above charges and tax settlements
    11,530       (6,370 )     31,405       (12,218 )
 
                       
 
                               
Adjusted income from continuing operations before the above charges
  $ 6,852     $ 2,419     $ 18,714     $ 1,097  
 
                       
 
                               
Adjusted basic EPS from continuing operations
  $ 0.07     $ 0.03     $ 0.20     $ 0.01  
 
                       
 
                               
Adjusted diluted EPS from continuing operations
  $ 0.07     $ 0.03     $ 0.20     $ 0.01  
 
                       
 
                               
Shares used in basic per share calculation
    92,626       84,055       91,357       83,795  
 
                       
 
                               
Shares used in diluted per share calculation
    95,316       86,543       94,612       86,543  
 
                       
Reconciliation of consolidated operating income to non-GAAP adjusted
earnings before interest, taxes, depreciation and amortization
(“EBITDA”)
                                                 
    Three Months Ended             Nine Months Ended        
    September 30,             September 30,        
    2005     2004     % Change     2005     2004     % Change  
Consolidated operating income (loss) (GAAP)
  $ 18,781     $ 8,090       132 %   $ (72,771 )   $ (5,290 )      
Depreciation and amortization
    22,823       20,652       11 %     68,321       62,521       9 %
 
                                       
EBITDA (non-GAAP) (a)
    41,604       28,742       45 %     (4,450 )     57,231        
Non-GAAP adjustments (b)
    135       3,331               126,905       39,796          
 
                                       
 
                                               
Adjusted EBITDA (non-GAAP) (a)
  $ 41,739     $ 32,073       30 %   $ 122,455     $ 97,027       26 %
 
                                       
 
(a)   We believe that EBITDA is a meaningful non-GAAP financial measure as an earnings-derived indicator that approximates cashflow. We calculate EBITDA by adding depreciation and amortization back to consolidated operating income. Adjusted EBITDA excludes the additional costs set forth in note (b) below. Adjusted EBITDA, as defined and presented by us, may not be comparable to similar measures reported by other companies.
 
(b)   See Tables 2, 2.1, 3 and 3.1 for explanation of non-GAAP adjustments.
See non-GAAP financial measure disclosure in Table 2.

 


 

Table 5
Valeant Pharmaceuticals International
Supplemental Sales Information
For the three and nine months ended September 30, 2005 and 2004

(in thousands)
                                                 
    Three Months Ended     %     Nine Months Ended     %  
    September 30,     Increase/     September 30,     Increase/  
    2005     2004     (Decrease)     2005     2004     (Decrease)  
Dermatology
                                               
Efudix/Efudex®(G)(P)
  $ 14,365     $ 15,442       (7 %)   $ 45,872     $ 34,216       34 %
Kinerase®(G)(P)
    5,921       3,777       57 %     16,177       11,875       36 %
Oxsoralen-Ultra®(G)(P)
    449       1,530       (71 %)     7,544       8,142       (7 %)
Dermatix(G)(P)
    2,249       1,794       25 %     6,711       5,098       32 %
Other Dermatology
    14,203       (a )           34,543       (a )      
 
                                               
Infectious Disease
                                               
Virazole®(G)(P)
    2,939       1,622       81 %     11,173       10,118       10 %
Other Infectious Disease
    4,952       (a )           15,049       (a )      
 
                                               
Neurology
                                               
Mestinon®(G)(P)
    12,206       11,067       10 %     32,500       30,327       7 %
Diastat(P)*
    17,525                   36,993              
Librax(P)
    4,042       2,811       44 %     9,792       11,314       (13 %)
Migranal(P)*
    3,744                   8,648              
Dalmane/Dalmadorm(P)
    2,597       3,155       (18 %)     8,568       8,870       (3 %)
Cesamet(P)
    2,919       1,474       98 %     6,893       3,252       112 %
Limbitrol(P)
    1,430       1,527       (6 %)     4,348       4,106       6 %
TASMAR®(G)(P)**
    1,438       2,121       (32 %)     3,910       2,705       45 %
Other Neurology
    10,958       (a )           37,050       (a )      
 
                                               
Other Therapeutic Classes
                                               
Bedoyecta(P)
    14,549       7,652       90 %     34,769       17,415       100 %
Solcoseryl
    5,837       4,426       32 %     13,942       13,637       2 %
Nyal(P)
    4,191       2,892       45 %     12,031       9,406       28 %
Bisocard(P)
    3,284       2,493       32 %     9,303       7,051       32 %
Calcitonin(P)
    1,835       1,509       22 %     7,154       8,122       (12 %)
Espaven(P)
    2,324       1,751       33 %     5,395       4,555       18 %
Aclotin(P)
    1,379       1,506       (8 %)     4,269       4,163       3 %
Espacil(P)
    1,909       1,336       43 %     4,000       3,591       11 %
Other Pharmaceutical Products
    45,759       81,214 (a)     (44 %)     149,001       233,095 (a)     (36 %)
 
                                       
 
                                               
Total Product Sales
  $ 183,004     $ 151,099       21 %   $ 525,635     $ 431,058       22 %
 
                                       
 
                                               
Total Global Brand Product Sales(G)
  $ 39,567     $ 37,353       6 %   $ 123,887     $ 102,481       21 %
 
                                       
 
                                               
Total Promoted Product Sales(P)
  $ 101,295     $ 65,459       55 %   $ 276,050     $ 184,326       50 %
 
                                       
 
(a)   In 2004, the Company tracked other products, but not by therapeutic classes; therefore, our ability to provide additional data by therapeutic classes is not practicable at this time. A total for other pharmaceutical products is not provided as the amount would not be comparable to 2005 periods.
 
(G)   Global products represent those products with targeted centralized promotional strategy.
 
(P)   Promoted products represent promoted products with annualized sales greater than $5 million.
 
*   Diastat and Migranal were acquired in March 2005; total sales of products acquired in the Xcel transaction were $22.9 million and $54.5 million for the three and nine months ended September 30, 2005, respectively.
 
**   Tasmar was acquired in April 2004.

 


 

Table 6
Valeant Pharmaceuticals International
Consolidated Condensed Statement of Revenue and Operating Income — Regional
For the three and nine months ended September 30, 2005 and 2004

(in thousands)
                                                 
    Three Months Ended             Nine Months Ended        
    September 30,             September 30,        
    2005     2004     % Change     2005     2004     % Change  
Revenues
                                               
 
                                               
Pharmaceuticals
                                               
North America
    60,524       36,613       65 %   $ 169,865     $ 99,500       71 %
Latin America
    43,420       38,514       13 %     116,877       104,158       12 %
Europe
    61,698       61,472             189,326       184,671       3 %
AAA
    17,362       14,500       20 %     49,567       42,729       16 %
 
                                       
Total pharmaceuticals
    183,004       151,099       21 %     525,635       431,058       22 %
 
                                               
Ribavirin royalty revenues
    21,953       15,333       43 %     65,494       63,444       3 %
 
                                       
 
                                               
Consolidated revenues
  $ 204,957     $ 166,432       23 %   $ 591,129     $ 494,502       20 %
 
                                       
 
                                               
Cost of goods sold
  $ 55,694     $ 49,264       13 %   $ 157,355     $ 141,914       11 %
 
                                       
 
                                               
Gross profit margin on pharmaceutical sales
    70 %     67 %             70 %     67 %        
 
                                       
 
                                               
Operating Income (Loss)
                                               
 
                                               
Pharmaceuticals
                                               
 
                                               
North America
  $ 16,117     $ 12,060       34 %   $ 49,363     $ 29,847       65 %
Latin America
    14,492       10,532       38 %     37,342       29,236       28 %
Europe
    9,858       14,245       (31 %)     30,729       25,772       19 %
AAA
    2,334       1,278       83 %     5,253       2,774       89 %
 
                                       
 
    42,801       38,115       12 %     122,687       87,629       40 %
 
                                               
Corporate expenses
    (14,955 )     (14,408 )     4 %     (43,666 )     (39,060 )     12 %
 
                                       
 
                                               
Total specialty pharmaceuticals
    27,846       23,707       17 %     79,021       48,569       63 %
 
                                               
Restructuring charges
    (135 )     69             (506 )     (20,116 )     (97 %)
R&D
    (8,930 )     (15,686 )     (43 %)     (24,887 )     (21,973 )     13 %
Acquired IPR&D
                      (126,399 )     (11,770 )     974 %
 
                                       
 
                                               
Total consolidated operating income (loss)
  $ 18,781     $ 8,090             $ (72,771 )   $ (5,290 )        
 
                                       
                                                                 
    Three Months Ended             Nine Months Ended        
    Sept. 30, 2005     %     Sept. 30, 2004     %     Sept. 30, 2005     %     Sept. 30, 2004     %  
Gross Profit
                                                               
 
                                                               
Pharmaceuticals
                                                               
 
                                                               
North America
  $ 49,092       81 %   $ 29,528       81 %   $ 136,657       80 %   $ 82,351       83 %
Latin America
    31,712       73 %     25,757       67 %     86,267       74 %     73,985       71 %
Europe
    37,420       61 %     38,488       63 %     119,572       63 %     111,690       60 %
AAA
    9,086       52 %     8,062       56 %     25,784       52 %     21,118       49 %
 
                                                       
 
                                                               
Total pharmaceuticals
  $ 127,310       70 %   $ 101,835       67 %   $ 368,280       70 %   $ 289,144       67 %
 
                                                       

 


 

Table 7
Valeant Pharmaceuticals International
Consolidated Balance Sheet and Other Data

(in thousands)
                 
    September 30,     December 31,  
    2005     2004  
Balance Sheet Data
               
 
               
Cash and cash equivalents
  $ 369,818     $ 222,590  
Marketable securities
    15,222       238,918  
 
           
Total cash and marketable securities
  $ 385,040     $ 461,508  
 
           
Accounts receivable, net
  $ 168,611     $ 171,860  
Inventory, net
    130,260       112,250  
Long-term debt
    789,721       793,139  
Total equity
    487,844       476,223  
                 
    Nine Months Ended  
    September 30,     September 30,  
    2005     2004  
Other Data
               
 
               
Cash flow provided by (used in) continuing operations
               
 
               
Operating activities
  $ 57,257     $ 37,933  
Investing activities
    (85,864 )     (170,147 )
Financing activities
    183,905       (362,237 )
Effect of exchange rate changes on cash and cash equivalents
    (8,070 )     1,082  
 
           
 
               
Net increase (decrease) in cash and cash equivalents
    147,228       (493,369 )
Net increase (decrease) in marketable securities
    (223,696 )     91,298  
 
           
 
               
Net decrease in cash and marketable securities
  $ (76,468 )   $ (402,071 )
 
           

 


 

Table 8
Valeant Pharmaceuticals International
Supplemental Non-GAAP Information on Currency Effect

(in thousands)
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2005     2004     2005     2004  
Consolidated
                               
 
                               
Product sales
  $ 183,004     $ 151,099     $ 525,635     $ 431,058  
Currency effect
    (6,166 )             (21,500 )        
Product sales, excluding currency impact
  $ 176,838             $ 504,135          
 
                               
Operating income (loss)
  $ 18,781     $ 8,090     $ (72,771 )   $ (5,290 )
Currency effect
    (2,013 )             (6,458 )        
Operating income, excluding currency impact
  $ 16,768             $ (79,229 )        
 
                               
Geographic Product Sales
                               
 
                               
North America pharmaceuticals
  $ 60,524     $ 36,613     $ 169,865     $ 99,500  
Currency effect
    (633 )             (1,665 )        
North America pharmaceuticals, excluding currency impact
  $ 59,891             $ 168,200          
 
                               
Latin America pharmaceuticals
  $ 43,420     $ 38,514     $ 116,877     $ 104,158  
Currency effect
    (3,288 )             (5,236 )        
Latin America pharmaceuticals, excluding currency impact
  $ 40,132             $ 111,641          
 
                               
Europe pharmaceuticals
  $ 61,698     $ 61,472     $ 189,326     $ 184,671  
Currency effect
    (1,838 )             (12,812 )        
Europe pharmaceuticals, excluding currency impact
  $ 59,860             $ 176,514          
 
                               
AAA pharmaceuticals
  $ 17,362     $ 14,500     $ 49,567     $ 42,729  
Currency effect
    (407 )             (1,787 )        
AAA pharmaceuticals, excluding currency impact
  $ 16,955             $ 47,780          
Note: Currency effect is determined by comparing adjusted 2005 reported amounts, calculated using 2004 monthly average exchange rates, to the actual 2004 reported amounts. Constant currency sales is not a GAAP defined measure of revenue growth. Constant currency sales as defined and presented by us may not be comparable to similar measures reported by other companies.

 

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