EX-99.1 2 a29763exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(Valean Logo)
Contact:
Jeff Misakian, Valeant Pharmaceuticals
949-461-6184
VALEANT PHARMACEUTICALS REPORTS
2007 FIRST QUARTER RESULTS
     ALISO VIEJO, Calif., May 1, 2007 — Valeant Pharmaceuticals International (NYSE: VRX) today reported results for the first quarter of 2007.
First Quarter 2007 vs. 2006 Highlights:
    Revenues increased seven percent to $213.4 million compared to $199.5 million.
 
    Product sales decreased two percent to $176.9 million compared to $181.4 million.
 
    Alliance revenue totaled $36.5 million compared to $18.1 million. Included in alliance revenue in the 2007 first quarter was a milestone payment of $19.2 million related to the out-licensing of pradefovir.
 
    Income from continuing operations was $8.6 million, or $0.09 per diluted share, compared to a loss of $5.8 million, or $0.06 per diluted share.
 
    Adjusted for non-GAAP items, income from continuing operations was $16.6 million, or $0.17 per diluted share, compared to a loss of $4.2 million, or $0.05 per diluted share. Excluding the pradefovir milestone payment, adjusted income from continuing operations was $0.03 per diluted share in the 2007 first quarter.
     Timothy C. Tyson, president and chief executive officer, said, “This clearly was a soft quarter for product sales. In many ways, this is typical for our business in that we often have lower sales in the first quarter along with higher marketing costs to support annual growth. This year, however, the first quarter was particularly impacted by a significant reduction in sales to certain wholesalers in Mexico and by lower sales of Infergen® and Efudex® in the United States. The reduced sales in Mexico were precipitated by a negotiating tactic of two major wholesalers, which we believe to be a transitory issue that is not reflective of underlying demand for our products. We were able to mitigate the effect of these challenging top-line issues on our margins and earnings in the quarter through expense management. We remain encouraged that underlying demand is stable or growing for most of our key products, and continue to believe that we will achieve growth at industry average rates or better in the year.”
Revenues:
     Product sales declined in the 2007 first quarter compared to the same period last year, primarily due to the aforementioned issues in the Mexican distribution chain, which significantly impacted sales of Bedoyecta™. In addition, sales of Infergen and Efudex were lower in the 2007 first quarter, while sales of Cesamet®, Kinerase®, Solcoseryl™ and Bisocard™ were higher. The

 


 

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effects of foreign currency exchange increased product sales by $4.1 million and operating income by $0.4 million in the 2007 first quarter.
     Alliance revenue in the 2007 first quarter included a milestone payment of $19.2 million from Schering-Plough upon the closing of the company’s out-licensing agreement for pradefovir. Also included in alliance revenue were royalties from the sale of ribavirin, which totaled $17.3 million in the 2007 first quarter, compared to $18.1 million in the same period last year.
Regional Sales Performance:
     North America product sales decreased six percent in the 2007 first quarter compared to the same period last year, primarily due to lower sales of Infergen and Efudex, partially offset by higher sales of Cesamet and Kinerase. The decrease in sales of Infergen largely reflects a decline in the overall market for interferon products in the United States. The decline in Efudex sales primarily reflects the pull-through of inventory from the launch of the company’s generic product at the end of 2006.
     Sales in the International region in the 2007 first quarter were $9.7 million, or 22 percent lower than the same period last year predominantly due to the distribution chain issues in Mexico, which affected sales of Bedoyecta and nearly all products in the country.
     Sales in the Europe, Middle East and Africa (EMEA) region increased 16 percent in the 2007 first quarter. Approximately half of the increase relates to the effects of foreign currency. In spite of continued government imposed price pressures in many European markets, Mestinon®, Solcoseryl, Bisocard and several other promoted products grew significantly. Much of this growth was generated in Central and Eastern Europe.
Financial Metrics:
     The company’s gross margin on product sales was 71 percent in the 2007 first quarter, compared to 68 percent in the same period last year. The improvement in gross margin was primarily due to fewer inventory write-offs in the current period and the impact on last year’s margin from a scheduled shutdown of the company’s manufacturing facility in Mexico.
     Selling expense was 36 percent of product sales in the 2007 first quarter compared to 35 percent in the same period last year. Selling expenses are typically higher in the first half of the year to support annual growth. General and administrative expenses were 14 percent of product sales in the 2007 first quarter compared to 16 percent in the same period last year. Included in general and administrative expenses in the 2007 first quarter was an expense of $3.8 million for an unfavorable arbitration decision in the company’s indemnification claim against former Xcel Pharmaceuticals shareholders relating to pre-acquisition sales, partially offset by a $2.2 million gain from the sale of the company’s contact lens business in Europe.

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     Research and development expenses were 13 percent of product sales in the 2007 first quarter compared to 16 percent in the same period last year. The decline was primarily due to the sale of the company’s discovery operations at the end of 2006.
Recent Developments and Expectations:
     The company previously excluded stock-based compensation expense from its metric performance and guidance figures in the year of implementation of SFAS 123R. Beginning with the first quarter of 2007, the company will no longer exclude these expenses, but has provided details of them in Table 6 for reference. The following table summarizes adjusted metric performance and expectations (including stock-based compensation expense):
                     
    2005A   2006A   1Q07A   2007E   2008E
Gross Margin
  70%   69%   71%   70-72%   72-75%
Cost of Goods Sold
  30%   31%   29%   28-30%   25-28%
Selling Expense
  31%   32%   36%   31-33%   28-32%
G & A
  15%   14%   14%   12-14%   11-13%
     Note: Includes non-GAAP adjustments.
Conference Call and Webcast Information:
     Valeant will host a conference call today at 10:00 a.m. EST (7:00 a.m. PST) to discuss its 2007 first quarter results. The dial-in number to participate on this call is (877) 295-5743, confirmation code 5535846. International callers should dial (706) 679-0845, confirmation code 5535846. A replay will be available approximately two hours following the conclusion of the conference call through Tuesday, May 8, 2007 and can be accessed by dialing (800) 642-1687, or (706) 645-9291, confirmation code 5535846. 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 specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
     Efudex, Cesamet, Kinerase, Mestinon, Bedoyecta, Solcoseryl and Bisocard are trademarks or registered trademarks of Valeant Pharmaceuticals International or its related companies. Infergen is a registered trademark of Amgen, Inc., and Valeant Pharmaceuticals North America is the exclusive licensee from Amgen of this mark. All other trademarks are the trademarks or the registered trademarks of their respective owners.

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FORWARD-LOOKING STATEMENTS:
     This press release contains forward-looking statements, including, but not limited to, statements regarding demand for the company’s products in Mexico and elsewhere, anticipated growth rates, and the company’s expected margins and expenses. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties related to projections of future sales, product development and regulatory approval, the execution and success of the company’s restructuring initiative and strategic plans, and other risks and uncertainties discussed in the company’s filings with the SEC. Valeant wishes to caution the reader that these factors 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 obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this release or to reflect actual outcomes.
NON-GAAP INFORMATION:
     To supplement the consolidated financial results prepared in accordance with generally accepted accounting principles (GAAP), the company uses non-GAAP financial measures that exclude certain items, such as, special charges and credits, stock-based compensation expense, gains on litigation settlements, and results of discontinued businesses. Management does not consider the excluded items part of day-to-day business or reflective of the core operational activities of the company as they result from transactions outside the ordinary course of business. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. Guidance is provided only on a non-GAAP basis due to the inherent difficulty in forecasting such items. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the company’s core operating results and trends for the periods presented. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP.
Financial Tables Follow
###

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Table 1
Valeant Pharmaceuticals International
Consolidated Condensed Statement of Income
For the Three Months Ended March 31, 2007 and 2006
                         
    Three Months Ended        
    March 31,        
(In thousands, except per share data)   2007     2006     % Change  
Product sales
  $ 176,892     $ 181,400       -2 %
Alliance revenue (including Ribavirin royalties) (a)
    36,470       18,091       102 %
 
                   
Total revenues
    213,362       199,491       7 %
 
                   
 
                       
Cost of goods sold
    52,098       58,601       -11 %
Selling expenses
    64,434       64,275       0 %
General and administrative expenses
    26,187       28,446       -8 %
Research and development costs
    23,110       29,554       -22 %
Gain on litigation settlement (b)
          (34,000 )        
Restructuring charges (c)
    7,238       26,466          
Amortization expense
    19,131       17,523       9 %
 
    192,198       190,865       1 %
 
                   
Income from operations
    21,164       8,626          
 
                       
Interest expense, net
    (6,441 )     (7,780 )        
Other income, net including translation and exchange
    1,136       938          
 
                   
 
                       
Income from continuing operations before provision for income taxes
    15,859       1,784          
 
                       
Provision for income taxes
    7,292       7,543          
Income (loss) from continuing operations
    8,567       (5,759 )        
 
                       
Income (loss) from discontinued operations, net
    1       (212 )        
 
                   
 
                       
Net income (loss)
  $ 8,568     $ (5,971 )        
 
                   
 
                       
Basic earnings per common share
                       
Income (loss) from continuing operations
  $ 0.09     $ (0.06 )        
Discontinued operations, net
                   
 
                   
Net income (loss)
  $ 0.09     $ (0.06 )        
 
                   
Shares used in per share computation
    94,574       92,770          
 
                   
 
                       
Diluted earnings per common share
                       
Income (loss) from continuing operations
  $ 0.09     $ (0.06 )        
Discontinued operations, net
                   
 
                   
Net income (loss)
  $ 0.09     $ (0.06 )        
 
                   
Shares used in per share computation
    96,012       92,770          
 
                   
(a) Alliance revenue for the quarter ended March 31, 2007 includes a $19.2 million milestone payment received from Schering-Plough related to the out-licensing of pradefovir and ribavirin royalties of $17.3 million. Alliance revenue for the quarter ended March 31, 2006 consists of ribavirin royaties of $18.1 million.
(b) Gain results from settlement of dispute with Republic of Serbia over joint venture.
(c) The $7.2 million charges relating to our restructuring program for the quarter ended March 31, 2007 includes $3.8 million for employee severances, $2.0 million for fees and other expenses relating to property and manufacturing facility sales and a further $1.4 million of impairment charges on assets being sold.

 


 

Table 2
Valeant Pharmaceuticals International
GAAP reconciliation of basic and diluted earnings per share
For the Three Months Ended March 31, 2007 and 2006
                 
    Three Months Ended  
    March 31,  
(In thousands, except per share data)   2007     2006  
Income (loss) from continuing operations
  $ 8,567     $ (5,759 )
 
               
Non-GAAP adjustments:
               
Gain on litigation settlement (a)
          (34,000 )
Professional fees related to Special Committee option investigation (b)
    630        
Restructuring charges (c)
    7,238       26,466  
Tax (d)
    174       9,096  
 
           
 
               
Adjusted income (loss) from continuing operations before the above charges
  $ 16,609     $ (4,197 )
 
           
 
               
Adjusted basic EPS from continuing operations
  $ 0.18     $ (0.05 )
 
           
 
               
Adjusted diluted EPS from continuing operations
  $ 0.17     $ (0.05 )
 
           
 
               
Shares used in basic per share calculation
    94,574       92,770  
 
           
 
               
Shares used in diluted per share calculation
    96,012       92,770  
 
           
(a) Gain results from settlement of dispute with Republic of Serbia over joint venture.
(b) Non-recurring professional fees relating to the investigation by the Special Committee into stock option practices and the related restatement of financial statements.
(c) Charges relate to our restructuring plan.
(d) Tax effect for non-GAAP adjustments, including tax benefits from U.S. net operating losses not recognized for GAAP purposes.

 


 

Table 3
Valeant Pharmaceuticals International
Reconciliation of consolidated operating income to non-GAAP adjusted earnings before interest,
taxes, depreciation and amortization (“EBITDA”)
For the Three Months Ended March 31, 2007 and 2006
                         
    Three Months Ended        
    March 31,        
    2007     2006     % Change  
Consolidated operating income (GAAP)
  $ 21,164     $ 8,626       145 %
Depreciation and amortization
    23,195       23,482       -1 %
 
                   
EBITDA (non-GAAP) (a)
    44,359       32,108       38 %
Other Non-GAAP adjustments (b)
    7,868       (7,534 )      
 
                   
 
                       
Adjusted EBITDA (non-GAAP) (a)
  $ 52,227     $ 24,574       113 %
 
                   
(a) We believe that EBITDA and adjusted EBITDA are meaningful non-GAAP financial measures as earnings-derived indicators of the cash flow generation ability of the company. 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. EBITDA and adjusted EBITDA, as defined and presented by us, may not be comparable to similar measures reported by other companies.
(b) See table 2 for explanation of non-GAAP adjustments.
To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles (GAAP), the company uses non-GAAP financial measures that exclude certain items, such as in-process research and development expenses, special charges and credits, and results of discontinued businesses. Management does not consider the excluded items part of the day-to-day business or reflective of the core operational activities of the company as they result from transactions outside the ordinary course of business. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. Guidance is provided only on a non-GAAP basis due to the inherent difficulty in forecasting such items.
By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the company’s core operating results and trends for the periods presented. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP.

 


 

Table 4
Valeant Pharmaceuticals International
Supplemental Sales Information
For the Three Months Ended March 31, 2007 and 2006

(In thousands)
                         
    Three Months Ended        
    March 31,     %  
                    Increase/  
    2007     2006     (Decrease)  
Neurology
                       
Diastat AcuDial(P)
  $ 11,072     $ 12,022       (8 %)
Mestinon(P)
    10,551       9,817       7 %
Cesamet(P)
    5,912       3,303       79 %
Librax
    3,667       2,919       26 %
Migranal(P)
    3,036       3,115       (3 %)
Dalmane/Dalmadorm(P)
    2,335       2,466       (5 %)
Tasmar(P)
    1,982       1,185       67 %
Melleril(P)
    1,541       1,408       9 %
Zelapar (P)
    195              
Other Neurology
    15,592       14,692       6 %
 
                       
Dermatology
                       
Efudix/Efudex(P)
    12,476       15,581       (20 %)
Kinerase(P)
    8,381       6,860       22 %
Oxsoralen-Ultra(P)
    3,883       3,508       11 %
Dermatix(P)
    2,773       1,834       51 %
Other Dermatology
    7,839       8,397       (7 %)
 
                       
Infectious Disease Infergen(P)
    8,970       13,705       (35 %)
Virazole(P)
    5,527       5,801       (5 %)
Other Infectious Disease
    5,159       4,731       9 %
 
                       
Other Therapeutic Classes Solcoseryl(P)
    5,347       3,377       58 %
Bisocard(P)
    4,694       3,565       32 %
Bedoyecta(P)
    4,623       10,580       (56 %)
MVI (multi-vitamin infusion)(P)
    2,493       2,267       10 %
Protamin(P)
    2,071       1,552       33 %
Espaven(P)
    1,867       1,302       43 %
Nyal(P)
    1,763       1,754       1 %
Other Pharmaceutical Products
    43,143       45,659       (6 %)
 
                   
 
                       
Total Product Sales
  $ 176,892     $ 181,400       (2 %)
 
                   
 
                       
Total Promoted Product Sales(P)
  $ 101,492     $ 105,002       (3 %)
 
                   
(P) Promoted products represent promoted products with estimated annualized sales greater than $5 million.

 


 

Table 5
Valeant Pharmaceuticals International
Consolidated Condensed Statement of Revenue and Operating Income — Regional
For the Three Months Ended March 31, 2007 and 2006

(In thousands)
                         
    Three Months Ended        
    March 31,        
Revenues   2007     2006     % Change  
North America
  $ 71,570     $ 75,856       -6 %
International
    35,457       45,189       -22 %
EMEA
    69,865       60,355       16 %
 
                   
Total specialty pharmaceuticals
    176,892       181,400       -2 %
 
                       
Alliance revenue (including Ribavirin royalties) (a)
    36,470       18,091       102 %
 
                   
 
                       
Consolidated revenues
  $ 213,362     $ 199,491       7 %
 
                   
 
                       
Cost of goods sold
  $ 52,098     $ 58,601       -11 %
 
                   
 
                       
Gross profit margin on pharmaceutical sales
    71 %     68 %        
 
                   
                         
    Three Months Ended        
    March 31,        
Operating Income   2007     2006     % Change  
North America
  $ 16,747     $ 23,136       -28 %
International
    475       9,172       -95 %
EMEA
    15,069       4,216       257 %
 
                   
 
    32,291       36,524       -12 %
 
                       
Corporate expenses
  $ (15,893 )   $ (23,142 )     -31 %
 
                   
 
                       
Total specialty pharmaceuticals
    16,398       13,382       23 %
 
                       
Restructuring charges
    (7,238 )     (26,466 )      
Gain on litigation settlement
          34,000        
R&D
    12,004       (12,290 )      
 
                   
 
                       
Total consolidated operating income
  $ 21,164     $ 8,626          
 
                   
                                 
    Three Months Ended        
    March 31,        
Gross Profit   2007     %     2006     %  
North America
  $ 59,939       84 %   $ 63,187       83 %
International
    24,013       68 %     28,438       63 %
EMEA
    40,842       58 %     31,174       52 %
 
                           
 
                               
Total specialty pharmaceuticals
  $ 124,794       71 %   $ 122,799       68 %
 
                           
(a) Alliance revenue for the quarter ended March 31, 2007 includes a $19.2 million milestone payment received from Schering-Plough related to the out-licensing of pradefovir and ribavirin royalties of $17.3 million. Alliance revenue for the quarter ended March 31, 2006 consists of ribavirin royalties of $18.1 million.

 


 

Table 6
Valeant Pharmaceuticals International
Consolidated Balance Sheet and Other Data

(In thousands)
                 
    March 31,     December 31,  
Balance Sheet Data   2007     2006  
Cash and cash equivalents
  $ 355,432     $ 326,002  
Marketable securities
    8,321       9,743  
 
           
Total cash and marketable securities
  $ 363,753     $ 335,745  
 
           
 
               
Accounts receivable, net
  $ 185,384     $ 227,452  
Inventory, net
    142,111       142,679  
Long-term debt
    778,756       778,196  
                 
    Three Months Ended  
    March 31,  
Other Data   2007     2006  
Cash flow provided by (used in) continuing operations
               
 
               
Operating activities
  $ 7,986     $ 40,838  
Investing activities
    23,633       (14,856 )
Financing activities
    (3,014 )     (7,205 )
Effect of exchange rate changes on cash and cash equivalents
    825       729  
 
           
 
               
Net increase in cash and cash equivalents
    29,430       19,506  
Net increase (decrease) in marketable securities
    (1,422 )     911  
 
           
 
               
Net increase in cash and marketable securities
  $ 28,008     $ 20,417  
 
           
                 
    Three Months Ended  
    March 31,  
Stock-Based Compensation   2007     2006  
 
               
Cost of goods sold
  $ 190     $ 435  
Selling expenses
    993       852  
General and administrative expenses
    2,493       3,532  
Research and development costs
    305       798  
 
           
 
               
Total
  $ 3,981     $ 5,617  
 
           

 


 

Table 7
Valeant Pharmaceuticals International
Supplemental Non-GAAP Information on Currency Effect

(In thousands)
                 
    Three Months Ended  
    March 31,  
    2007     2006  
Consolidated
               
 
               
Product sales
  $ 176,892     $ 181,400  
Currency effect
    (4,102 )        
Product sales, excluding currency impact
  $ 172,790          
 
               
Operating income
  $ 21,164     $ 8,626  
Currency effect
    (372 )        
Operating income, excluding currency impact
  $ 20,792          
 
               
Geographic Product Sales
               
 
               
North America pharmaceuticals
  $ 71,570     $ 75,856  
Currency effect
    177          
North America pharmaceuticals, excluding currency impact
  $ 71,747          
 
               
International pharmaceuticals
  $ 35,457     $ 45,189  
Currency effect
    386          
International pharmaceuticals, excluding currency impact
  $ 35,843          
 
               
EMEA pharmaceuticals
  $ 69,865     $ 60,355  
Currency effect
    (4,665 )        
EMEA pharmaceuticals, excluding currency impact
  $ 65,200          
Note: Currency effect is determined by comparing adjusted 2007 reported amounts, calculated using 2006 monthly average exchange rates, to the actual 2006 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.