e8vk
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 31, 2006
CYTOKINETICS, INCORPORATED
(Exact name of registrant as specified in its charter)
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DELAWARE
(State or other jurisdiction of
incorporation)
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000-50633
(Commission File Number)
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94-3291317
(IRS Employer
Identification No.) |
280 East Grand Avenue
South San Francisco, California 94080
(Address of principal executive offices, including zip code)
650-624-3000
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c)) |
TABLE OF CONTENTS
ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
On January 31, 2006, Cytokinetics, Incorporated issued a press release announcing its results
for the fourth quarter and the year ended December 31, 2005. A copy of the press release has been
filed as Exhibit 99.1 to this report and is incorporated by reference herein.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
The following Exhibit is filed as part of this Current Report on Form 8-K:
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Exhibit No. |
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Description |
99.1
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Press Release, dated January 31, 2006. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CYTOKINETICS, INCORPORATED
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By: |
/s/ James H. Sabry
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James H. Sabry |
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Date: January 31, 2006 |
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President and Chief Executive Officer |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
99.1
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Press Release, dated January 31, 2006. |
exv99w1
Exhibit 99.1
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Cytokinetics, Incorporated
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Burns McClellan, Inc. |
Sharon Surrey-Barbari
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Clay A. Kramer (investors) |
SVP, Finance and CFO
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Justin Jackson (media) |
(650) 624-3000
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(212) 213-0006 |
CYTOKINETICS, INCORPORATED REPORTS
FOURTH QUARTER AND YEAR END 2005 FINANCIAL RESULTS
Company Provides Update on Development Programs and 2006 Guidance
SOUTH SAN FRANCISCO, CA, January 31, 2006 Cytokinetics, Incorporated (Nasdaq: CYTK), reported
revenues from research and development collaborations of $2.1 million for the fourth quarter of
2005. Net loss for the fourth quarter of 2005 was $11.1 million or $0.38 per share. As of December
31, 2005, cash, cash equivalents, restricted cash and marketable securities totaled $81.4 million.
We made significant progress in 2005 by advancing both our oncology and cardiovascular programs.
In the past year, we observed the first evidence of clinical activity for one of our drug
candidates, ispinesib, and reported that data at the San Antonio Breast Cancer Symposium in
December. We believe that these results demonstrated encouraging anti-cancer activity supportive
of further clinical investigation, stated James H. Sabry, M.D., Ph.D., President and Chief
Executive Officer. By the end of 2006, we expect our novel drug candidates to be or to have been
evaluated in up to 20 clinical trials and anticipate the initiation over the next 12-18 months of
clinical trials for two additional potential drug candidates. Our platform of drug discovery
directed to cytoskeletal pharmacology continues to generate novel mechanism compounds and we look
forward to further clinical trials data in 2006 that support the potential therapeutic value of
these compounds.
Company Highlights
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In December, interim data from an ongoing Phase II clinical trial of ispinesib
(SB-715992), our novel Kinesin Spindle Protein (KSP) inhibitor, were presented at the 2005
San Antonio Breast Cancer Symposium. The clinical poster presentation highlighted results
from an ongoing Phase II clinical trial that is designed to assess the safety, tolerability
and efficacy of ispinesib in patients with locally advanced or metastatic breast cancer.
At the time of the interim analysis, the best overall responses observed with ispinesib had
been partial responses in 3 of 33 evaluable patients as measured by the Response Evaluation
Criteria in Solid Tumors (RECIST). These three patients had maximum decreases in tumor
size ranging from 46% to 68% with the duration of response ranging from 7.1 weeks to 13.4
weeks. The overall response rate for all 33 evaluable patients was 9% with a median time
to progression of 5.7 weeks. The adverse events were manageable, predictable and
consistent with the Phase I clinical trial experience of ispinesib. The most common
adverse event was Grade 4 neutropenia. This clinical trial has progressed to the second
stage of enrollment in which an additional 25 patients are planned to be evaluated. |
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In the fourth quarter, Cytokinetics continued a Phase I clinical trial with CK-1827452,
our novel small molecule activator of cardiac myosin, for the treatment of patients with
heart failure. This Phase I clinical trial, being conducted in the United Kingdom, is a
double-blind, randomized, placebo-controlled clinical trial evaluating the safety,
tolerability, pharmacokinetics and pharmacodynamic profile of CK-1827452 in an intravenous
formulation in normal healthy volunteers. This dose-escalating clinical trial will also
measure effects of the drug candidate on left ventricular function assessed through serial
echocardiograms. In December, Cytokinetics selected CK-1827452 as a development candidate
for the potential treatment of patients with chronic heart failure using an oral
formulation in the outpatient setting. |
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During the fourth quarter, GlaxoSmithKline (GSK) completed patient enrollment and
initiated data collection from Stage 1 of a Phase II clinical trial designed to evaluate
ispinesib as monotherapy in the second-line treatment of patients with advanced non-small
cell lung cancer (NSCLC) whose disease had initially responded and then relapsed following
a platinum-containing regimen. In addition, GSK continued to enroll patients in a Phase II
clinical trial designed to evaluate ispinesib as monotherapy in the second-line treatment
of patients with advanced ovarian cancer. |
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In November, Cytokinetics and GSK presented data from two Phase Ib combination clinical
trials of ispinesib at the 2005 AACR-NCI-EORTC International Meeting in Philadelphia that
suggest ispinesib has an acceptable tolerability profile and no pharmacokinetic
interactions when used in combination with each of two common chemotherapeutic |
-more-
Cytokinetics Q4 Financials Press Release
January 31, 2006
Page 2
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agents in patients suffering from advanced solid tumors. One presentation contained data
from an ongoing clinical trial that demonstrated that the combination of ispinesib and
capecitabine appears to have an acceptable tolerability profile on the clinical trials
treatment schedule. The second presentation contained data from a clinical trial that
demonstrated that the combination of ispinesib with docetaxel has an acceptable tolerability
profile on a once every 21 day schedule. The regimen-limiting toxicity in this second
clinical trial was prolonged (> 5 days) Grade 4 neutropenia which was consistent
with the Phase I experience and clinical experience. |
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GSK continued to enroll patients in a third dose-escalating Phase Ib clinical trial,
designed to evaluate the safety, tolerability and pharmacokinetics of ispinesib in
combination with carboplatin. |
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The National Cancer Institute (NCI), in collaboration with GSK, continued patient
enrollment in five additional Phase II clinical trials of ispinesib. In these trials,
ispinesib is being evaluated in the first-line or second-line treatment of patients with
head and neck cancers, the second-line treatment of patients with hormone-refractory
prostate cancer, the second-line treatment of patients with colorectal cancer, the
first-line treatment of patients with hepatocellular cancer and the first-line treatment of
patients with melanoma. In addition, the NCI plans to initiate an additional Phase II
clinical trial to evaluate the potential efficacy of ispinesib as second-line treatment of
patients with renal cell cancer. |
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The NCI, in collaboration with GSK, continued patient enrollment in two additional Phase
I clinical trials designed to evaluate the safety, tolerability and pharmacokinetics of
ispinesib on a more dose-dense schedule than in other clinical trials conducted to date by
GSK or the NCI. One clinical trial is enrolling patients with advanced solid tumors that
have failed to respond to all standard therapies. The other clinical trial is enrolling
patients with acute leukemia, chronic myelogenous leukemia or advanced myelodysplastic
syndromes. |
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During the fourth quarter, GSK continued to enroll patients in a dose-escalating Phase I
clinical trial of SB-743921, our second KSP inhibitor. This clinical trial is designed to
evaluate the safety, tolerability and pharmacokinetics of SB-743921 in advanced cancer
patients. |
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In December, GSK selected a novel small molecule development candidate, GSK-923295,
directed against a second mitotic kinesin target, Centromere-Associated Protein E (CENP-E),
under the broad strategic alliance between GSK and Cytokinetics established in June 2001.
CENP-E is directly involved in coupling the mechanics of mitosis with the mitotic
checkpoint signaling machinery. These processes are essential to cell proliferation. The
selection of the development candidate triggered a milestone payment of $500,000 from GSK
to Cytokinetics under the terms of the strategic alliance. |
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During the fourth quarter, Cytokinetics entered into a committed equity financing
facility with Kingsbridge Capital Limited, a private investment group, in which Kingsbridge
has committed to provide up to $75.0 million of capital over the next three years through the
purchase of newly-issued shares of Cytokinetics common stock. Under the terms of the
agreement, Cytokinetics can, subject to certain conditions and limitations, determine the
exact timing and amount of any draw-downs. |
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In January 2006, Cytokinetics sold $33.0 million of its common stock in a registered
direct offering pursuant to a shelf registration statement previously filed with the
Securities and Exchange Commission. Under the terms of the transaction, Cytokinetics sold
5.0 million shares of common stock at a price of $6.60 per share to a select group of
institutional investors. Pacific Growth Equities, LLC acted as a financial advisor to
Cytokinetics on this offering. Net proceeds from the offering were approximately $31.9
million after all offering expenses. |
Financials
Revenues from research and development collaborations for the fourth quarter of 2005 were $2.1
million, compared to revenues in the fourth quarter of 2004 of $2.2 million. Revenues were derived
from research collaborations with GSK and AstraZeneca. The decline in collaborative research
revenues for the fourth quarter of 2005, as compared to the fourth quarter of 2004, was a result of a
reduction in funding of $0.6 million, partially offset by higher milestone revenue of $0.5 million.
Total research and development (R&D) expenses in the fourth quarter of 2005 were $10.7 million,
compared to $11.2 million for the same period in 2004. The decreased spending in the fourth
quarter of 2005 was primarily due to a reduction in spending related to Cytokinetics proprietary
technologies and early research programs, offset in part by increased spending related to the
advancement of Cytokinetics oncology and cardiovascular programs.
Total general and administrative (G&A) expenses for the fourth quarter of 2005 were $3.1 million,
a decrease of $0.2 million from $3.3 million for the same period in 2004. The decrease over the prior
year was primarily due to property taxes recorded in 2004, partially offset by increased outside
services in 2005 associated with being a public company.
Cytokinetics Q4 Financials Press Release
January 31, 2006
Page 3
The net loss for the three months ended December 31, 2005 was $11.1 million, or $0.38 per share.
This compares to a net loss of $11.8 million, or $0.42 per share, for the same period in 2004.
Cytokinetics also reported results of its operations for the twelve months ended December 31, 2005.
Revenues from research and development collaborations and grants for the twelve month period were
$8.9 million, compared to revenues of $13.4 million for the same period in 2004. The $4.5 million
decrease in revenues for the twelve months ended December 31, 2005, as compared to the same period
in 2004, was primarily due to the receipt of $3.3 million in milestone payments from GSK in 2004
compared with a $0.5 million milestone payment in 2005, along with a reduction in funding of $1.7
million primarily by GSK in 2005. The milestone payments of $3.3 million from GSK in 2004 were
primarily related to the initiation of a Phase II clinical trials
program for ispinesib. The
milestone payment of $0.5 million in 2005 was related to the selection of a second mitotic kinesin
development candidate, GSK-923295, by GSK in the fourth quarter of 2005.
Total R&D expenses for the twelve months ended December 31, 2005 were $40.6 million, compared to
$39.9 million for the same period in 2004. The increased spending in 2005 was primarily due to the
advancement of Cytokinetics oncology and cardiovascular programs, partially offset by decreased
spending on proprietary technologies and early research programs.
Total G&A expenses for the twelve months ended December 31, 2005 were $13.0 million, compared to
$12.0 million for the same period in 2004. The increase in G&A expenses was primarily due to
increased outside services associated with being a public company.
The net loss for the twelve months ended December 31, 2005 was $42.3 million, or $1.48 per share,
compared to a net loss of $37.2 million, or $1.88 per share, for the same period in 2004.
Financial Guidance for 2006
Cytokinetics also announced its financial guidance for 2006. Cytokinetics revenue guidance for
2006 is in the range of $4.0 to $5.0 million. Guidance for
R&D expenses is in the range of $67.0 to
$71.0 million and G&A expense guidance is in the range of
$18.0 to $20.0 million. This guidance includes
the estimated effects of Cytokinetics adoption in the first quarter of 2006 of FAS 123R,
Share-Based Payments, which requires the expensing of stock-based compensation. Cytokinetics
estimates non-cash stock-based compensation expense under FAS123R to be approximately $5.1 million
in 2006.
During 2006, Cytokinetics will provide updates of its financial guidance for the year at each
quarterly financial reporting period.
Company Milestones for 2006
Oncology
Ispinesib (SB-715992)
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Data anticipated from the platinum-sensitive treatment arm of GSKs Phase II NSCLC
clinical trial in the first quarter of 2006. |
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Additional data anticipated from GSKs Phase II clinical trial of second- or third-line
therapy in patients with breast cancer in 2006. |
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Data anticipated from GSKs Phase II clinical trial of second-line therapy in patients
with ovarian cancer in the first half of 2006. |
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Data anticipated from GSKs Phase Ib clinical trial evaluating ispinesib in combination
with carboplatin in the first half of 2006. |
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Data anticipated from one or more of the NCIs five ongoing Phase II clinical trials in 2006. |
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Initiation of an NCI Phase II clinical trial in the treatment of patients with renal cell cancer in 2006. |
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Data anticipated from one or both of the NCIs two ongoing Phase I clinical trials in 2006. |
SB-743921
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Additional data anticipated from GSKs Phase I clinical trial in advanced solid tumor
patients in the first half of 2006. |
Cytokinetics Q4 Financials Press Release
January 31, 2006
Page 4
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Expected initiation of our Phase I/II clinical trial in patients with Non-Hodgkins
Lymphoma in the first quarter of 2006. |
GSK-923295
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Expected IND filing by GSK in 2006. |
The clinical trial milestones for the oncology program are based on information provided by GSK or
NCI. The occurrence of these events is outside of our control.
Cardiovascular
CK-1827452, intravenous formulation
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Data anticipated from our Phase I clinical trial in healthy volunteers in the first half of 2006. |
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Expected initiation of our Phase II clinical trials program in the second half of 2006. |
CK-1827452, oral formulation
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Expected initiation of our Phase I oral bioavailability clinical trial in the second
half of 2006. |
Annual Stockholders Meeting
Cytokinetics Annual Stockholders Meeting will be held at the Embassy Suites in South San
Francisco, CA at 10:00 AM on May 25, 2006.
Conference Call and Webcast Information
Members of our management team will review fourth quarter results via 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 4707088.
An archived replay of the webcast will be available via Cytokinetics website until February 28,
2006. 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 4707088 from January 31, 2006
at 5:30 PM Eastern Time until February 7, 2006.
About Cytokinetics
Cytokinetics is a leading biopharmaceutical company focused on the discovery, development and
commercialization of novel small molecule drugs that specifically target 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, cardiovascular disease
and other diseases. Cytokinetics has developed a cell biology driven approach and proprietary
technologies to evaluate the function of many interacting proteins in the complex environment of
the intact human cell. Cytokinetics employs the PUMA system and Cytometrix technologies to enable
early identification and automated prioritization of compounds that are highly selective for their
intended protein targets without other cellular effects, and may therefore be less likely to give
rise to clinical side effects. Cytokinetics and GlaxoSmithKline (GSK) have entered into a strategic
alliance to discover, develop and commercialize small molecule therapeutics targeting human mitotic
kinesins for applications in the treatment of cancer and other diseases. GSK is conducting Phase II
and Ib clinical trials for ispinesib (SB-715992) and a Phase I clinical trial for SB-743921.
Ispinesib, SB-743921 and GSK-923295 are being developed under the broad strategic alliance with
GSK. Cytokinetics heart failure program is the second program to leverage the companys expertise
in cytoskeletal pharmacology. Cytokinetics recently initiated a Phase I human clinical trial with
CK-1827452, a novel small molecule cardiac myosin activator, for the treatment of acute heart
failure and also selected CK-1827452 as a potential drug candidate for the treatment of chronic
heart failure via oral administration. 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
Cytokinetics Q4 Financials Press Release
January 31, 2006
Page 5
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 the expected initiation, timing,
scope, enrollment and results of Cytokinetics and Cytokinetics partners clinical development and
research programs, including Cytokinetics research and development milestones for 2006 and
anticipated dates of release of data from clinical trials, statements regarding our financial
guidance, including expected revenues and R&D and G&A expenses for 2006, and statements regarding
the potential benefits of Cytokinetics drug candidates and potential drug candidates and the
enabling capabilities of Cytokinetics proprietary technologies. Such statements are based on
managements current expectations, but actual results may differ materially due to various factors.
Such statements involve risks and uncertainties, including, but not limited to, those risks and
uncertainties relating to decisions by GSK and the NCI to postpone or discontinue development
efforts for one or more compounds and other potential difficulties or delays in development,
testing, regulatory approval, production and marketing of Cytokinetics drug candidates that could
slow or prevent clinical development, product approval or market acceptance (including the risks
relating to uncertainty of patent protection for Cytokinetics intellectual property or trade
secrets, Cytokinetics ability to obtain additional financing if necessary and unanticipated
research and development and other costs), the timing and receipt of funds under Cytokinetics
collaborations and the implementation and maintenance of procedures, policies, resources and
infrastructure relating to compliance with new or changing laws, regulations and practices
applicable to public companies. For further information regarding these and other risks related to
Cytokinetics business, investors should consult Cytokinetics filings with the Securities and
Exchange Commission.
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Cytokinetics
Q4 Financials Press Release
January 31, 2006
Page 6
Condensed Statement of Operations
(in thousands, except per share data)
(unaudited)
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Three Months Ended |
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Twelve Months Ended |
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December 31, |
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December 31, |
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December 31, |
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December 31, |
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2005 |
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2004 |
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2005 |
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2004 |
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Revenues: |
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Research and development and grant revenues |
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$ |
1,444 |
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$ |
1,526 |
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$ |
6,112 |
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$ |
10,642 |
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License revenues |
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700 |
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700 |
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2,800 |
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|
2,800 |
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Total revenues |
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2,144 |
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2,226 |
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8,912 |
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13,442 |
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Operating Expenses: |
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Research and development |
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10,735 |
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11,213 |
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40,570 |
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39,885 |
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General and administrative |
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3,105 |
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3,303 |
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12,975 |
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11,991 |
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Total operating expenses |
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13,840 |
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14,516 |
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53,545 |
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51,876 |
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Operating loss: |
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(11,696 |
) |
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|
(12,290 |
) |
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(44,633 |
) |
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(38,434 |
) |
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Interest and other income |
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760 |
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626 |
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2,916 |
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|
1,785 |
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Interest and other expense |
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|
(145 |
) |
|
|
(156 |
) |
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(535 |
) |
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(549 |
) |
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Net loss |
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$ |
(11,081 |
) |
|
$ |
(11,820 |
) |
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$ |
(42,252 |
) |
|
$ |
(37,198 |
) |
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Net loss per common share basic and diluted |
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$ |
(0.38 |
) |
|
$ |
(0.42 |
) |
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$ |
(1.48 |
) |
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$ |
(1.88 |
) |
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Weighted average shares used in computing net loss per
common share basic and diluted |
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28,844,212 |
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|
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28,265,365 |
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28,582,145 |
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19,779,123 |
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Cytokinetics
Q4 Financials Press Release
January 31, 2006
Page 7
Condensed Balance Sheet Data
(in thousands)
(unaudited)
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December 31, |
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December 31, |
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2005 |
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2004 |
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Assets |
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Cash and cash equivalents |
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$ |
13,515 |
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$ |
13,061 |
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Short term investments |
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62,697 |
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92,637 |
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Other current assets |
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2,652 |
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|
|
3,369 |
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Total current assets |
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78,864 |
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|
109,067 |
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Long term investments |
|
|
|
|
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4,555 |
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Property and equipment, net |
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6,178 |
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|
7,336 |
|
|
|
|
|
|
|
|
|
|
Restricted investments |
|
|
5,172 |
|
|
|
5,980 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
1,247 |
|
|
|
1,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
91,461 |
|
|
$ |
128,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and centers equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
11,264 |
|
|
$ |
11,039 |
|
|
|
|
|
|
|
|
|
|
Long-term obligations |
|
|
6,636 |
|
|
|
9,506 |
|
|
|
|
|
|
|
|
|
|
Stockholders equity |
|
|
73,561 |
|
|
|
107,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
91,461 |
|
|
$ |
128,101 |
|
|
|
|
|
|
|
|