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 | |
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|
|
| |
|
|
| |
|
|
| |
|
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|
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 | |
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|
|
| |
|
|
| |
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|
|
|
Total operating expenses | | | 11,070 | | | | 11,319 | | | | 46,109 | | | | 41,926 | |
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|
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|
Loss from operations | | | (7,236 | ) | | | (721 | ) | | | (23,217 | ) | | | (10,537 | ) |
Net interest income | | | 287 | | | | 196 | | | | 1,091 | | | | 869 | |
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Net loss | | $ | (6,949 | ) | | $ | (525 | ) | | $ | (22,126 | ) | | $ | (9,668 | ) |
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Basic and diluted net loss per common share | | $ | (0.24 | ) | | $ | (0.02 | ) | | $ | (0.77 | ) | | $ | (0.38 | ) |
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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 | |
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Total | | 6,361 | | | 5,940 | | | 6,757 | | | 19,058 | | | 3,834 | | | 22,892 | |
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|
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 | |
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| |
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| |
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Total | | 10,744 | | | 11,388 | | | 12,907 | | | 35,039 | | | 11,070 | | | 46,109 | |
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|
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|
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|
Loss fr Operation | | (4,383 | ) | | (5,448 | ) | | (6,150 | ) | | (15,981 | ) | | (7,236 | ) | | (23,217 | ) |
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net intererst | | 258 | | | 268 | | | 278 | | | 804 | | | 287 | | | 1,091 | |
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Other inc/exp | | | | | | | | | | | 0 | | | | | | 0 | |
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Total | | 258 | | | 268 | | | 278 | | | 804 | | | 287 | | | 1,091 | |
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|
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|
| |
|
| |
|
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Net loss | | (4,125 | ) | | (5,180 | ) | | (5,872 | ) | | (15,177 | ) | | (6,949 | ) | | (22,126 | ) |
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| |
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 | |
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subtotal stk comp | | 298 | | | 137 | | | 147 | | | 582 | | | 175 | | | 757 | |
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| |
|
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Total | | 10,744 | | | 11,388 | | | 12,907 | | | 35,039 | | | 11,070 | | | 46,109 | |
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|
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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 | |
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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 | |
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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 | |
| | | | | | | | | | | |
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| |
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subtotal Epo | | | | | | | | | | | | | (2,533,348 | ) | | | (505,024 | ) | | | (3,038,372 | ) |
| | | | | | | | |
Geldanamycin | | | | | | | | | | | | | (1,332,802 | ) | | | 1,750,101 | | | | 417,299 | |
| | | | | | | | | | | |
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|
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| | | | | | | | | | | | $ | (3,866,149 | ) | | $ | 1,245,077 | | | $ | (2,621,072 | ) |