Cytokinetics, Incorporated Reports Fourth Quarter and Year End 2008 Financial ResultsCompany Updates Progress on Programs and Provides Milestones and Financial Guidance for 2009SOUTH SAN FRANCISCO, CA - February 10, 2009 Cytokinetics, Incorporated (Nasdaq: CYTK), reported revenues from research and development collaborations of $3.2 million for the fourth quarter of 2008. The net loss for the three months ended December 31, 2008 was $10.9 million, or $0.22 per share compared to a net loss of $13.3 million, or $0.27 per share for the same period in 2007. As of December 31, 2008, cash, cash equivalents, restricted cash and investments totaled $76.3 million.
Revenues from research and development collaborations for the fourth quarter of 2008 were $3.2 million, compared to $3.1 million for the same period in 2007. Revenues for the fourth quarter of 2008 and 2007 were primarily derived from the company's collaboration and option agreement with Amgen, Inc. Total research and development (R&D) expenses in the fourth quarter of 2008 were $11.5 million, compared to $14.0 million for the same period in 2007. The decrease in R&D expenses in the fourth quarter of 2008, compared to the same period in 2007, was primarily due to decreased laboratory and personnel expenses, which were partially offset by increased spending related to the company's clinical trial programs. Total general and administrative (G&A) expenses for the fourth quarter of 2008 were $2.8 million, compared to $4.1 million for the same period in 2007. The decrease in G&A expenses in the fourth quarter of 2008, compared to the same period in 2007, was primarily due to decreased legal fees and personnel expenses. Cytokinetics also reported results of its operations for the twelve months ended December 31, 2008. Revenues from research and development collaborations for the twelve months ended December 31, 2008 were $12.4 million, compared to revenues of $13.6 million for the same period in 2007. The decrease in collaborative research revenues in 2008, as compared to the same period in 2007, was primarily the result of lower revenue from the company's collaboration with GSK. Total R&D expenses for the twelve months ended December 31, 2008 were $54.0 million, compared to $53.4 million for the same period in 2007. The increase in R&D expenses in 2008, compared to the same period in 2007, was primarily due to higher clinical trial related costs, which were offset in part by decreased laboratory and personnel expenses. Total G&A expenses for the twelve months ended December 31, 2008 were $15.1 million, compared to $16.7 million for the same period in 2007. The decreased G&A expenses in 2008, compared to the same period in 2007, was primarily due to decreased legal and personnel expenses. The net loss for the twelve months ended December 31, 2008, which included $2.5 million in restructuring charges, was $56.4 million, or $1.14 per share, compared to a net loss of $48.9 million, or $1.03 per share, for the same period in 2007. Company Milestones for 2009 Cardiovascular CK-1827452
GSK-923295
Cytokinetics also announced its financial guidance for 2009. The company anticipates its 2009 net cash utilization to be in the range of $52.0 to $57.0 million, with cash R&D expenses expected to be in the range of $38.0 to $42.0 million and cash G&A expenses to be in the range of $14.0 to $15.0 million. On this basis, the company believes that it has over 12 months of cash resources to fund operations. While Amgen may choose to exercise its option for an exclusive license to develop and commercialize CK-1827452, there is no certainty this will occur. Accordingly, this financial guidance excludes any revenues associated with such an option exercise by Amgen, including any projections regarding potential reimbursement of R&D expenses related to CK-1827452. This guidance also does not take into account revenues from other potential collaborations that Cytokinetics may enter into in 2009 relating to CK-1827452 or other programs. If Amgen does exercise its option, Cytokinetics will provide an update to its 2009 financial guidance, taking into account the $50 million option exercise fee that Amgen would pay to the company, as well as any other payments that Cytokinetics may receive from Amgen for R&D activities related to CK-1827452 that it may conduct under Amgen's sponsorship. Cytokinetics expects that if Amgen exercises its option related to CK-1827452, the company's cash resources would be then sufficient for approximately 24 months of operations. This financial guidance is on a cash basis and does not include an estimated $12.0 million in GAAP revenues related to Amgen's initial payment for its option for a license of CK-1827452 and $7.5 million in non-cash related operating expenses primarily related to FAS 123R stock compensation expense. Annual Stockholders' Meeting Cytokinetics' Annual Stockholders' Meeting will be held at the Embassy Suites Hotel located at 250 Gateway Boulevard in South San Francisco, CA at 10:00 AM on May 21, 2009. Conference Call and Webcast Information Members of Cytokinetics' management team will review fourth quarter and year end results via a webcast and conference call today at 4:30 PM Eastern Time. The webcast can be accessed in the Investor Relations section of Cytokinetics' website at www.cytokinetics.com. The live audio of the conference call is also accessible via telephone to investors, members of the news media and the general public by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 81393620. An archived replay of the webcast will be available via Cytokinetics' website until February 24, 2009. 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 81393620 from February 10, 2009 at 5:30 PM Eastern Time until February 24, 2009. About Cytokinetics Cytokinetics is a biopharmaceutical company with a focus on muscle contractility that engages in the discovery, development and commercialization of novel small molecule drugs that may address areas of significant unmet clinical needs. Cytokinetics' cardiovascular disease program is focused on 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, is in Phase II clinical trials for the treatment of heart failure. Amgen Inc. has obtained an option for an exclusive license to develop and commercialize CK-1827452, subject to Cytokinetics' development and commercial participation rights. In April 2008, Cytokinetics announced the selection of a potential drug candidate, CK-2017357, directed towards skeletal muscle contractility which may be developed as a potential treatment for skeletal muscle weakness associated with neuromuscular diseases or other conditions. In January 2009, Cytokinetics announced the selection of a potential drug candidate directed towards smooth muscle contractility which may be developed as a potential treatment for diseases associated with bronchoconstriction and vasoconstriction. Cytokinetics' cancer program is focused on mitotic kinesins, a family of motor proteins essential to cell division. Cytokinetics is developing two drug candidates that have arisen from this program, ispinesib and SB-743921, each an inhibitor of kinesin spindle protein, a mitotic kinesin. In addition, Cytokinetics and GlaxoSmithKline are conducting research and development activities focused on GSK-923295, an inhibitor of centromere-associated protein E (CENP-E). All of these drug candidates and potential drug candidates have arisen from Cytokinetics' research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. 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 Act's safe harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Amgen's potential exercise of its option to CK-1827452; Cytokinetics' financial guidance, including expected cash operating expenditures, revenues and R&D and G&A expenses for 2009; Cytokinetics' and its partners' research and development activities, including the initiation, conduct, focus, scope and completion of clinical trials, the utility of clinical trial results, the anticipated availability and presentation of clinical trial results, the initiation and progression of IND-enabling studies and the timing and occurrence of IND filings; the potential receipt of payments under Cytokinetics' strategic alliance with Amgen; potential future collaborations; and the properties and potential benefits of Cytokinetics' compounds. 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 approvals for trial commencement, progression or production of Cytokinetics' compounds that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics' compounds may have 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 or maintain patent or trade secret protection for its intellectual property; Amgen may elect not to exercise its option with respect to CK-1827452; GSK may alter or terminate its development activities for GSK-923295; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain the additional funding necessary to conduct development of some or all of its compounds; standards of care may change rendering Cytokinetics' compounds obsolete; others may introduce products or alternative therapies for the treatment of indications Cytokinetics' compounds may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including option fees, milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission. |