EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

Contact:         
Kosan Biosciences         
Susan M. Kanaya    Shari Annes    
Chief Financial Officer    (650) 888-0902 (cell)    
(510) 732-8400 ext. 5227    (510) 731-5260    
kanaya@kosan.com    annes@kosan.com    

 

FOR IMMEDIATE RELEASE

 

Kosan Reports 2004 Fourth Quarter and Year End Financial Results,

Provides 2005 Financial Guidance

 

Hayward, CA. February 24, 2005 – Kosan Biosciences Incorporated (Nasdaq: KOSN) today reported financial results for the quarter and year ended December 31, 2004. Revenues were $3.8 million and $22.9 million for the quarter and year ended December 31, 2004, respectively, compared to $10.6 million and $31.4 million in the same periods in 2003. Lower revenue in 2004 was primarily due to $6.0 million in non-recurring milestones recognized in 2003 relating to Kosan’s epothilone global development and commercialization agreement with Roche, of which $4.0 million was recognized in the fourth quarter 2003.

 

Total operating expenses were $11.1 million and $46.1 million for the quarter and year ended December 31, 2004, compared to $11.3 million and $41.9 million in the same periods last year. The year-to-year increase primarily reflects costs associated with the clinical advancement of drug candidates from Kosan’s two broad-based oncology programs. In the Company’s epothilone program, KOS-862 entered into Phase II and Phase Ib clinical trials, and follow-on compound KOS-1584 was advanced into Phase I. In Kosan’s Hsp90 inhibitor program, KOS-953, its proprietary formulation of 17-AAG, entered into Phase I and Phase Ib clinical trials. At the same time, the Company continued its investment in advancing its research and development pipeline of additional potential product candidates largely based on polyketides. Kosan’s total operating expenses do not reflect costs incurred by partners Roche or the NCI in connection with clinical trials they are conducting in connection with the Company’s epothilone and Hsp90 inhibitor programs, respectively.

 

Net losses for the quarter ended December 31, 2004 were $6.9 million, or $0.24 per share, compared to $0.5 million, or $0.02 per share, in the same period for the prior year. The net loss for the year ended December 31, 2004 was $22.1 million, or $0.77 per share, compared to $9.7 million, or $0.38 per share, in the same period in 2003. At December 31, 2004, cash, cash equivalents and marketable securities totaled $83.4 million, compared to $105.3 million at December 31, 2003.

 

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Q4 Earnings – Page 2

 

Kosan’s Financial Outlook for 2005

 

Kosan provides the following financial guidance for 2005, which reflects the anticipated expansion of clinical testing of KOS-953 and DMAG, geldanamycin analogs in the Company’s Hsp90 inhibitor program.

 

    Revenues: Kosan anticipates 2005 revenues in the range of $7 million to $10 million. Lower revenues in 2005 primarily reflect the contractual expiration of Roche’s funding of the epothilone analog program, one segment of the overall Roche-Kosan partnership that was devoted to identifying follow-on compounds to KOS-862 and KOS-1584, as well as the discontinuation of funding for the KOS-862 Phase II clinical trial in non-small cell lung cancer that was terminated in Q4 2004.

 

    Operating Expenses: Kosan expects 2005 operating expenses in the range of $45 million to $50 million. Such expenses reflect the anticipated clinical advancement of its Hsp90 inhibitor and epothilone programs, as well as the Company’s continued efforts to strengthen and advance its pipeline.

 

    Net Loss: Kosan expects to report a net loss in 2005 in the range of $35 million to $40 million.

 

    Cash and Investments: Kosan expects to end 2005 with cash and investments in excess of $40 million, reflecting a net cash use in the range of $40 million to $45 million.

 

About Kosan

 

Kosan Biosciences has two first-in-class anticancer agents in Phase II and Phase Ib clinical trials: KOS-862 (Epothilone D) and 17-AAG, a geldanamycin analog and Hsp90 inhibitor. KOS-862, the company’s lead drug candidate, has a mechanism of action similar to taxanes and is partnered with Roche in a global development and commercialization agreement, along with a follow-on compound, KOS-1584, currently in Phase I testing. 17-AAG targets multiple pathways required for tumor growth and is being developed in collaboration with the National Cancer Institute, in addition to a second-generation geldanamycin analog, DMAG, now in Phase I trials. Kosan’s proprietary formulation of 17-AAG, KOS-953, is in Phase I and Phase Ib trials. Kosan has generated a pipeline of potentially significant products for cancer, infectious disease and other therapeutic areas based on its proprietary technologies for discovering, developing and manufacturing polyketide analogs. Polyketides are an important class of natural products that have yielded numerous pharmaceuticals for the treatment of cancer, infectious diseases, high cholesterol, transplant rejection and other diseases. For additional information on Kosan Biosciences, please visit the Company’s website at www.kosan.com.

 

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Q4 Earnings – Page 3

 

This press release contains “forward-looking” statements, including statements with respect to expected 2005 revenues, operating expenses, net loss and cash and investments and statements with respect to further development of Kosan’s product candidates including those related to KOS-862, KOS-1584, 17-AAG, KOS-953 and DMAG in the treatment of cancer. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. There are a number of important factors that could cause the results of Kosan to differ materially from those indicated by these forward-looking statements, including, among others, risks and uncertainties related to the clinical advancement of KOS-862, KOS-1584 and geldanamycin analogs and the costs of conducting clinical studies for these product candidates; Kosan’s dependence on its collaborations with Roche and the NCI for development of its product candidates; Kosan’s dependence on its collaboration with Roche for most of its revenues; the possibility that Kosan may require more cash than anticipated for its operating activities; and other risks detailed from time to time in the Company’s SEC reports, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2004, and other periodic filings with the SEC. Kosan does not undertake any obligation to update forward-looking statements.

 

FINANCIAL TABLE FOLLOWS

 

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Selected Financial Information

 

Condensed Statements of Operations

(in thousands, except per share amounts)

 

    

Three Months Ended

December 31,


   

Year Ended

December 31,


 
     2004

    2003

    2004

    2003

 
     (unaudited)     (unaudited)        

Revenues:

                                

Contract revenue

   $ 3,417     $ 10,039     $ 20,493     $ 28,482  

Grant revenue

     417       559       2,399       2,907  
    


 


 


 


Total revenues

     3,834       10,598       22,892       31,389  

Operating expenses:

                                

Research and development

     9,544       9,966       40,175       36,789  

General and administrative

     1,526       1,353       5,934       5,137  
    


 


 


 


Total operating expenses

     11,070       11,319       46,109       41,926  
    


 


 


 


Loss from operations

     (7,236 )     (721 )     (23,217 )     (10,537 )

Net interest income

     287       196       1,091       869  
    


 


 


 


Net loss

   $ (6,949 )   $ (525 )   $ (22,126 )   $ (9,668 )
    


 


 


 


Basic and diluted net loss per common share

   $ (0.24 )   $ (0.02 )   $ (0.77 )   $ (0.38 )
    


 


 


 


Shares used in computing basic and diluted net loss per common share

     29,062       26,095       28,913       25,567  

 

Condensed Balance Sheets

(in thousands)

 

     December 31,

     2004

   2003

     (unaudited)     

Cash, cash equivalents and marketable securities

   $ 83,393    $ 105,299

Total assets

   $ 96,613    $ 123,189

Deferred revenue

   $ 15,430    $ 20,859

Total liabilities

   $ 27,427    $ 33,737

Total liabilities and stockholders’ equity

   $ 96,613    $ 123,189

Shares issued and outstanding

     29,096      28,753


Kosan Biosciences, Inc

Press Release Support

Q4 2004

(in thousands)

 

     Three Months Ended

          Year Ended

       
     December 31,
2004


    December 31,
2003


    $ change

    December 31,
2004


    December 31,
2003


    $ change

 

Net loss (incl stock based comp)

     (6,949 )     (525 )   6,424       (22,126 )     (9,668 )   12,458  

Per share

   $ (0.24 )   $ (0.02 )   0.22     $ (0.77 )   $ (0.38 )   0.39  

Revenues

     3,834       10,598     6,764       22,892       31,389     8,497  

Operating expenses

     11,070       11,319     249       46,109       41,926     (4,183 )

Weighted avg shares

     29,062       26,095             28,913       25,567        
     12/31/2004

    12/31/2003

                         

Cash and cash equivalents

     83,393       105,299     (21,906 )                      


Kosan Biosciences Incorporated

P& L Rollforward

 

     2004

 
    

Qtr

Q1


   

Qtr

Q2


   

Qtr

Q3


   

YTD

Q3


   

Qtr

Q4


   

YTD

Q4


 

Contract Rev

   6,123     5,111     5,842     17,076     3,417     20,493  

Grant Rev

   238     829     915     1,982     417     2,399  
    

 

 

 

 

 

Total

   6,361     5,940     6,757     19,058     3,834     22,892  
    

 

 

 

 

 

R & D

   9,341     10,000     11,290     30,631     9,544     40,175  

G & A

   1,403     1,388     1,617     4,408     1,526     5,934  
    

 

 

 

 

 

Total

   10,744     11,388     12,907     35,039     11,070     46,109  
    

 

 

 

 

 

Loss fr Operation

   (4,383 )   (5,448 )   (6,150 )   (15,981 )   (7,236 )   (23,217 )
    

 

 

 

 

 

net intererst

   258     268     278     804     287     1,091  
    

 

 

 

 

 

Other inc/exp

                     0           0  
    

 

 

 

 

 

Total

   258     268     278     804     287     1,091  
    

 

 

 

 

 

Net loss

   (4,125 )   (5,180 )   (5,872 )   (15,177 )   (6,949 )   (22,126 )
    

 

 

 

 

 

Depts excluding stock-based comp        

R & D

   9,079     9,879     11,175     30,133     9,448     39,581  

G & A

   1,367     1,372     1,585     4,324     1,447     5,771  
Stk Comp                                     

R & D

   262     121     115     498     96     594  

G & A

   36     16     32     84     79     163  
    

 

 

 

 

 

subtotal stk comp

   298     137     147     582     175     757  
    

 

 

 

 

 

Total

   10,744     11,388     12,907     35,039     11,070     46,109  
    

 

 

 

 

 

 

 


Project reporting for Press Release

 

     FTEs

         Outside Svcs

    Total FTEs & Svcs

 
     Q1

   Q2

   Q3

   Q4

   Mo Avg

   cost @340K

    YTD Total

   
2003                                                  

Epothilone D

   19.32    23.39    27.45    23.35    23.38      7,948,917       9,274,394     $ 17,223,311  

Epo Analogs & Other Work

   3.45    7.88    12.44    13.35    9.28      3,154,633       1,342,283       4,496,916  
    
  
  
  
  
  


 


 


subtotal Epo

   22.8    31.3    39.9    36.7    32.66    $ 11,103,550     $ 10,616,677     $ 21,720,227  

Geldanamycin

   15.29    11.49    11.61    12.33    12.68      4,310,917       820,564     $ 5,131,481  
     Q1

   Q2

   Q3

   Q4

   Total

   cost @339K

             
2004                                                  

Epothilone D

   26.54    15.87    7.75    5.32    13.87      4,702,778       6,301,653     $ 11,004,431  

Epo Analogs & Other Work

   12.69    13.77    11.83    7.34    11.41      3,867,425       3,810,000       7,677,425  
    
  
  
  
  
  


 


 


subtotal Epo

   39.2    29.6    19.6    12.7    25.28    $ 8,570,203     $ 10,111,653     $ 18,681,856  

Geldanamycin

   8.21    7.34    7.79    11.80    8.79      2,978,115       2,570,665     $ 5,548,780  
variance                                                  

Epo

                            $ (3,246,139 )   $ (2,972,741 )   $ (6,218,880 )

Epo Analogs

                              712,792       2,467,717       3,180,509  
                             


 


 


subtotal Epo

                              (2,533,348 )     (505,024 )     (3,038,372 )

Geldanamycin

                              (1,332,802 )     1,750,101       417,299  
                             


 


 


                              $ (3,866,149 )   $ 1,245,077     $ (2,621,072 )