Cytokinetics, Incorporated Reports Third Quarter 2007 Financial ResultsCompany Provides Update on Cardiovascular and Oncology Clinical ProgramsSOUTH SAN FRANCISCO, CA - October 31, 2007 Cytokinetics, Incorporated (Nasdaq: CYTK) reported revenues from research and development collaborations of $4.1 million for the third quarter of 2007. Net loss for the third quarter of 2007 was $11.3 million, or $0.24 per share. As of September 30, 2007, cash, cash equivalents, restricted cash and marketable securities totaled $158.1 million.
Revenues from research and development collaborations for the third quarter of 2007 were $4.1 million, compared to $0.1 million in the third quarter of 2006. Revenues for the third quarter of 2007 were derived from license revenue of $3.1 million from our collaboration and option agreement with Amgen, and a milestone payment from GSK of $1.0 million for the initiation of a Phase I clinical trial for GSK-923295. Revenues in 2006 were derived from our collaboration and license agreement with GSK. Total research and development (R&D) expenses for the third quarter of 2007 were $13.2 million, compared to $12.5 million for the third quarter of 2006. The increase in R&D expenses in the third quarter of 2007 over the same period in 2006 was primarily due to increased spending for clinical and preclinical outsourcing costs, as well as higher personnel expenses. Total general and administrative (G&A) expenses for the third quarter of 2007 were $4.1 million, compared to $3.6 million in the third quarter of 2006. The increase in G&A expenses in the third quarter of 2007 over the same period in 2006 was primarily due to increased personnel and medical education expenses offset in part by lower patent and legal fees. The net loss for the three months ended September 30, 2007 was $11.3 million, or $0.24 per share, compared to a net loss for the same period in 2006 of $14.9 million, or $0.41 per share. Cytokinetics also reported results of its operations for the nine months ended September 30, 2007. Revenues from research and development collaborations for the nine months ended September 30, 2007 were $10.5 million, compared to revenues of $3.0 million for the same period in 2006. Revenues for the first nine months of 2007 were largely derived from license revenue from Amgen. Revenues for first nine months of 2006 were largely derived from our collaboration and license agreement with GSK. The increase in collaborative research revenues for the first nine months of 2007, as compared to the same period in 2006, was primarily the result of the recognition of $9.2 million of license revenue from Amgen. Total R&D expenses for the nine months ended September 30, 2007 were $39.4 million, compared to $36.2 million for the same period in 2006. The increase in R&D expenses in the first nine months of 2007, over the same period in 2006, was primarily due to increased spending for clinical and preclinical outsourcing costs, as well as higher personnel and facilities expenses. Total G&A expenses for the nine months ended September 30, 2007 were $12.6 million, compared to $11.1 million for the same period in 2006. The increased spending in the first nine months of 2007, over the same period in 2006, was largely attributable to increased personnel expense, along with higher accounting services fees. The net loss for the nine months ended September 30, 2007, was $35.6 million, or $0.76 per share, compared to a net loss of $41.2 million, or $1.15 per share, for the same period in 2006. Update on Financial Guidance for 2007 Cytokinetics reaffirmed its previous revenue guidance for 2007, which is estimated to be in the range of $11.0 million to $13.0 million. Cytokinetics is announcing that it has lowered its financial expense guidance for 2007. Guidance for R&D expenses is being reduced to be in the range of $55.0 million to $60.0 million, down from its previous guidance of between $70.0 million and $75.0 million. G&A expense guidance remains in the range of $17.0 million to $19.0 million. This guidance includes the estimated effects of FAS 123R, Share-Based Payments, which requires the expensing of stock-based compensation. Updated Company Milestones Cardiovascular CK-1827452:
Ispinesib:
Members of the Cytokinetics management team will review third quarter 2007 results via webcast and conference call today at 4:30 p.m. Eastern Time. To access the live webcast, please log-on in the Investor Center section of Cytokinetics' website at www.cytokinetics.com. Investors, members of the news media and the general public may access the call by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 20558492. An archived replay of the webcast will be available via Cytokinetics' website until November 15, 2007. The replay will also be available via telephone by dialing (800) 642-1687 (United States and Canada) or (706) 645-9291 (International) and typing in the passcode 20558492 from October 31, 2007 at 5:30 p.m. Eastern Time until November 15, 2007. About Cytokinetics Cytokinetics is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that may address areas of significant unmet clinical needs. Cytokinetics' development efforts are directed to advancing multiple drug candidates through clinical trials to demonstrate proof-of-concept in humans, specifically in the areas of heart failure and cancer. Cytokinetics' cardiovascular disease program is focused to cardiac myosin, a motor protein essential to cardiac muscle contraction. Cytokinetics' lead compound from this program, CK-1827452, a novel small molecule cardiac myosin activator, entered Phase II clinical trials for the treatment of heart failure in 2007. Under a strategic alliance established in 2006, Cytokinetics and Amgen Inc. plan to conduct research with activators of cardiac myosin in order to identify potential treatments for patients with heart failure. Amgen has obtained an option for the joint development and commercialization of CK-1827452 exercisable during a defined period, the ending of which is dependent on Cytokinetics' conduct of further clinical trials of CK-1827452. Cytokinetics' cancer program is focused on mitotic kinesins, a family of motor proteins essential to cell division. Under a strategic alliance established in 2001, Cytokinetics and GlaxoSmithKline (GSK) are conducting research and development activities focused on the potential treatment of cancer. Cytokinetics is developing two novel drug candidates that have arisen from this program, Ispinesib and SB-743921, each a novel inhibitor of kinesin spindle protein (KSP), a mitotic kinesin. Cytokinetics believes that Ispinesib has demonstrated clinical activity in Phase II monotherapy clinical trials in breast cancer, ovarian cancer and non-small cell lung cancer and plans to conduct additional clinical trials with Ispinesib. Cytokinetics is also conducting a Phase I/II trial of SB-743921 in non-Hodgkin's lymphoma. GSK has obtained an option for the joint development and commercialization of Ispinesib and SB-743921, exercisable during a defined period. Cytokinetics and GSK are conducting collaborative research activities directed to the mitotic kinesin centromere-associated protein E (CENP-E). GSK-923295, a CENP-E inhibitor, is being developed under the strategic alliance by GSK, subject to Cytokinetics' option to co-fund certain later-stage development activities and to co-promote any resulting approved drug in North America. GSK began a Phase I clinical trial with GSK-923295 in 2007. All of these drug candidates have arisen from Cytokinetics' research efforts and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Cytokinetics' focus on the cytoskeleton enables it to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer and cardiovascular disease. Additional information about Cytokinetics can be obtained at www.cytokinetics.com. This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements relating to Cytokinetics' financial guidance, including expected revenues and R&D and G&A expenses for 2007; Cytokinetics' ability to draw down capital under its CEFF with Kingsbridge; Cytokinetics' and its partners' planned research and development activities, including the initiation, enrollment, conduct, design and progression of clinical trials, the utility of systolic ejection time as an indicator of drug effect for CK-1827452, anticipated timing of availability of clinical trial data and initiation of additional sites and increased enrollment rates for clinical trials; the potential benefits of Cytokinetics' drug candidates and potential drug candidates; and the enabling capabilities of Cytokinetics' biological focus. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approval, production and marketing of Cytokinetics' drug candidates that could slow or prevent clinical development, product approval or market acceptance, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, enrolling patients for clinical trials may be difficult or take longer than anticipated, Cytokinetics' drug candidates may have unexpected adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials, and Cytokinetics may be unable to obtain and maintain patent or trade secret protection for its intellectual property; potential decisions by GSK to postpone or discontinue development efforts for GSK-923295; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing if necessary; standards of care may change or others may introduce products or alternative therapies for the treatment of indications Cytokinetics' drug candidates and potential drug candidates currently or potentially target; Cytokinetics' ability to timely obtain effectiveness of a registration statement permitting resale of securities to be issued by Cytokinetics under, and in connection with, the CEFF; and risks and uncertainties relating to the timing and receipt of funds under Cytokinetics' collaborations. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission. View financial statements |