Icos Corp · 8-K · For 4/18/05 · EX-99

Filed On 4/18/05 3:01pm ET   ·   SEC File 0-19171   ·   Accession Number 1157523-5-3404

Current Report   ·   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Icos Corporation                                       2     11K 
 2: EX-99       Miscellaneous Exhibit                                  5±    22K 

EX-99   ·   Miscellaneous Exhibit

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                                                                      Exhibit 99

Lilly ICOS LLC Reports Results for First Quarter of 2005; 
Cialis Leads ED Market in France with 49% Market Share in February 2005;
Alpha-Blocker Contraindication Removed from the U.S. Label for Cialis 

    BOTHELL, Wash. & INDIANAPOLIS--(BUSINESS WIRE)--April 18, 2005--Lilly ICOS
LLC (Lilly ICOS) (NYSE:LLY)(Nasdaq:ICOS) is releasing its financial results for 
the first quarter ended March 31, 2005. Worldwide sales of Cialis(R) (tadalafil)
increased 39% in the first quarter of 2005, to $150.1 million, compared to      
$108.3 million in the first quarter of 2004. Reported U.S. sales of Cialis, from
Lilly ICOS into the wholesaler channel, were $42.7 million in the first quarter 
of 2005, compared to $32.8 million in the first quarter of 2004. During the 2005
first quarter, U.S. wholesalers continued to reduce their inventory levels of   
Cialis, in accordance with the terms of agreements recently entered into. Lilly 
ICOS estimates that U.S. wholesaler inventories of Cialis were reduced by       
approximately $27 million during the 2005 first quarter.                        

Cialis Net Sales:                                                               
-----------------                                                               
(in millions)                                                                   
Three Months              
Ended             
March 31,             
---------------             
2005    2004            
------- -------             
Lilly ICOS Territories:                                                         
United States         $42.7   $32.8                                   
Europe(1)              56.3    36.3                                   
Canada and Mexico      12.2     5.9                                   
------- -------             
Total Lilly ICOS   111.2    75.0                                
Lilly Territories           38.9    33.3                                        
------- -------             
Worldwide Total      $150.1  $108.3                                   
======= =======             

(1) Austria, Belgium, Denmark, Finland, France, Germany, Greece,                
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway,               
Portugal, Spain, Sweden, Switzerland and the United Kingdom.            

  In France, Cialis has led the ED market in January and February 2005. In
February 2005, Cialis attained 49% share of the market after being commercially 
available just two years.(2)                                                    
     "We are delighted, but not surprised, that Cialis overtook Viagra to become
the number one selling ED treatment in France," stated Paul Clark, ICOS Chairman
and Chief Executive Officer. "In the U.S., Cialis has continued to gain total   
prescription market share every month since it was launched, reaching 21.8% of  
total prescriptions in March 2005. We continue to expect Lilly ICOS to achieve  
profitability around mid-2005, and look forward to providing additional         
information in the ICOS Corporation conference call, scheduled for May 5, 2005."
Khoso Baluch, Lilly Vice President, U.S. Diabetes and Family Health   
Business Unit commented, "The key benefit of Cialis -- up-to-36 hours that      
Cialis gives a man and his partner to choose the moment for intimacy that is    
right for them -- is important to many couples."                                
   Baluch added, "A new group of patients in the U.S. is now eligible to use
Cialis. In March 2005, the FDA authorized a U.S. product label change related to
the use of Cialis with alpha blockers. Cialis had been contraindicated with     
alpha blockers other than tamsulosin 0.4 mg once daily. Following review of data
regarding the use of Cialis with alpha-blockers, the FDA concluded this         
contraindication is no longer warranted. The label now includes precaution      
language along with alpha blocker drug interaction data. We are very pleased    
with this change."                                                              

2005 First Quarter Financial Results                                  

   For the three months ended March 31, 2005, Lilly ICOS reported a net loss
of $41.7 million, compared to a net loss of $138.8 million for the three months 
ended March 31, 2004. The decreased net loss results from an overall increase of
$37.3 million in total revenue, combined with a $59.8 million reduction in total
expenses.                                                                       
    Total Lilly ICOS revenue for the first quarter of 2005 was $119.0 million,
compared to $81.7 million for the first quarter of 2004. Lilly ICOS revenue for 
the 2005 period includes $7.8 million in royalties on sales reported by Lilly,  
compared to $6.7 million in royalty revenue for the first quarter of 2004. The  
increase in Lilly ICOS revenue reflects the continued growth of Cialis in the   
Lilly ICOS territories since its 2003 introduction, as well as its global       
expansion to approximately 100 countries today.                                 
     In December 2004, Lilly ICOS began to reduce U.S. wholesaler inventories of
Cialis to targeted levels and, by early February 2005, was party to new         
agreements with its U.S. wholesalers. As a result, it is estimated that         
approximately $27 million of U.S. wholesaler inventory reductions of Cialis     
occurred during the first quarter of 2005.                                      
   Selling, general and administrative expenses decreased $58.0 million from
the first quarter of 2004, to $137.0 million in the first quarter of 2005. The  
decrease is primarily due to the high level of sales and marketing expenses, in 
early 2004, shortly after Cialis was launched in the U.S.                       
  Research and development expenses declined to $13.9 million in the first
quarter of 2005, compared to $18.8 million in the first quarter of 2004,        
primarily due to the completion of certain activities associated with the U.S.  
launch of Cialis.                                                               

About Lilly ICOS LLC                                                  

   Lilly ICOS LLC, a joint venture equally owned by ICOS Corporation and Eli
Lilly and Company, is marketing Cialis for the treatment of erectile dysfunction
in North America and Europe.                                                    
ICOS Corporation, a biotechnology company headquartered in Bothell,   
Washington, is dedicated to bringing innovative therapeutics to patients.       
Through Lilly ICOS LLC, ICOS is marketing its first product, Cialis, for the    
treatment of erectile dysfunction. ICOS is working to develop treatments for    
serious unmet medical conditions such as benign prostatic hyperplasia, cancer   
and inflammatory diseases.                                                      
Eli Lilly and Company, a leading innovation-driven corporation, is    
developing a growing portfolio of first-in-class and best-in-class              
pharmaceutical products by applying the latest research from its own worldwide  
laboratories and from collaborations with eminent scientific organizations.     
Headquartered in Indianapolis, Indiana, Lilly provides answers -- through       
medicines and information -- for some of the world's most urgent medical needs. 
Except for historical information contained herein, this press release
contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Such forward-looking statements are based on     
current expectations, estimates and projections about the industry, management  
beliefs and certain assumptions made by the management of ICOS and Lilly.       
Investors are cautioned that matters subject to forward-looking statements      
involve risks and uncertainties, including economic, competitive, governmental, 
technological, legal and other factors discussed in the two companies'          
respective filings with the Securities and Exchange Commission, which may affect
the business and prospects of the two companies and Lilly ICOS. Results and the 
timing and outcome of events may differ materially from those expressed or      
implied by the forward-looking statements in this press release. More           
specifically, there can be no assurance that Cialis will achieve commercial     
success or that competing products will not pre-empt market opportunities that  
might exist for the product.                                                    
  The forward-looking statements contained in this press release represent
ICOS' and Lilly's judgment as of the date of this release. Neither ICOS nor     
Lilly undertake any obligation to update any forward-looking statements.        

     (2) IMS Health, IMS MIDAS (based on PDE5 inhibitor tablets from wholesalers
to pharmacies) February 2005.                                                   

Lilly ICOS LLC          
Condensed Consolidated Statements of Operations           
(in thousands)          
(unaudited)           

                        Three Months Ended
                         March 31,
                        --------------------------
                        2005          2004
                        ------------   -----------
Revenue                                                                         
Product sales, net                   $   111,194   $    75,017              
Royalties                                  7,790         6,652              
                        ------------  ------------
Total revenue                       118,984        81,669         
                        ------------  ------------

Expenses                                                                        
Cost of sales                              9,752         6,573              
Selling, general and administrative      137,027       195,053              
Research and development                  13,874        18,827              
                        ------------  ------------
Total expenses                      160,653       220,453         
                        ------------  ------------
Net loss                               $   (41,669)  $  (138,784)               
                        ============  ============

Lilly ICOS LLC          
SUMMARIZED OPERATING RESULTS          
(in thousands)          
(unaudited)           

2005            2004
     ---------   ---------------------
    Q1          Q1          Q2
    ----------  ----------  ----------
Revenue:                                                                        
Product sales, net:                                                           
United States          $  42,744   $  32,807   $  50,768                    
Europe                    56,264      36,356      45,301                    
Canada and Mexico         12,186       5,854       8,931                    
     ---------   ----------- ---------
     111,194      75,017     105,000
Royalties                   7,790       6,652       6,449                     
     ---------   ---------   ---------
Total revenue            118,984      81,669     111,449                    
     ---------   ---------   ---------
Expenses:                                                                       
Cost of sales               9,752       6,573       8,982                     
Selling, general and                                                          
administrative           137,027     195,053     157,838                    
Research and                                                                  
development               13,874      18,827      15,119                    
     ---------   ---------   ---------
Total expenses           160,653     220,453     181,939                    
     ---------   ---------   ---------
Net loss                 $ (41,669)  $(138,784)  $ (70,490)                     
     =========   =========   =========

  2004
    ----------------------------------
     Q3          Q4        TOTAL
    ----------  ----------  ----------
Revenue:                                                                        
Product sales, net:                                                           
United States          $  70,226   $  52,783   $ 206,584                    
Europe                    43,414      52,859     177,930                    
Canada and Mexico          9,380      13,063      37,228                    
     ----------- ----------- ---------
     123,020     118,705     421,742
Royalties                   6,210       6,809      26,120                     
     ---------   ---------   ---------
Total revenue            129,230     125,514     447,862                    
     ---------   ---------   ---------
Expenses:                                                                       
Cost of sales              10,173      10,338      36,066                     
Selling, general and                                                          
administrative           123,222     130,398     606,511                    
Research and                                                                  
development               17,203      16,169      67,318                    
     ---------   ---------   ---------
Total expenses           150,598     156,905     709,895                    
     ---------   ---------   ---------
Net loss                 $ (21,368)  $ (31,391)  $(262,033)                     
     =========   =========   =========

CONTACT: Lilly                                                        
Terra Fox, 317-276-5795                             
or                                                  
ICOS                                                
Lacy Fitzpatrick, 425-415-2207                      

Dates Referenced Herein   and   Documents Incorporated By Reference

This 8-K Filing		Date		Other Filings
		3/31/04		10-Q
		3/31/05		10-Q, 4, SC 13G/A
Filed On / Filed As Of / For The Period Ended		4/18/05
		5/5/05		10-Q, 4, 8-K
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