e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
or
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number: 000-50633
CYTOKINETICS, INCORPORATED
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
94-3291317 |
(State or other jurisdiction of
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
Identification Number) |
|
|
|
280 East Grand Avenue |
|
|
South San Francisco, California
|
|
94080 |
(Address of principal executive offices)
|
|
(Zip Code) |
Registrants telephone number, including area code: (650) 624-3000
Indicate by check mark whether the registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated file o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
Number of shares of common stock, $0.001 par value, outstanding as of April 30, 2007:
46,812,188
CYTOKINETICS, INCORPORATED
TABLE OF CONTENTS FOR FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2007
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CYTOKINETICS, INCORPORATED
(A Development Stage Enterprise)
CONDENSED BALANCE SHEETS
(In thousands, except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 (1) |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
104,048 |
|
|
$ |
39,387 |
|
Short-term investments |
|
|
65,499 |
|
|
|
70,155 |
|
Related party accounts receivable |
|
|
133 |
|
|
|
42,071 |
|
Related party notes receivable short-term portion |
|
|
226 |
|
|
|
160 |
|
Prepaid and other current assets |
|
|
1,754 |
|
|
|
1,848 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
171,660 |
|
|
|
153,621 |
|
Property and equipment, net |
|
|
8,667 |
|
|
|
9,202 |
|
Related party notes receivable long-term portion |
|
|
226 |
|
|
|
292 |
|
Restricted cash |
|
|
6,125 |
|
|
|
6,034 |
|
Other assets |
|
|
317 |
|
|
|
367 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
186,995 |
|
|
$ |
169,516 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES and STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,815 |
|
|
$ |
2,838 |
|
Accrued liabilities |
|
|
5,647 |
|
|
|
7,466 |
|
Related party payables and accrued liabilities |
|
|
115 |
|
|
|
164 |
|
Short-term portion of equipment financing lines |
|
|
4,039 |
|
|
|
3,691 |
|
Deferred revenue |
|
|
12,234 |
|
|
|
12,234 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
23,850 |
|
|
|
26,393 |
|
Long-term portion of equipment financing lines |
|
|
7,654 |
|
|
|
7,144 |
|
Long-term portion of deferred revenue |
|
|
33,542 |
|
|
|
29,666 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
65,046 |
|
|
|
63,203 |
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value: Authorized: 120,000,000 shares;
Issued and outstanding: 46,812,256 shares in 2007 and 43,283,558 shares in 2006 |
|
|
47 |
|
|
|
43 |
|
Additional paid-in capital |
|
|
365,073 |
|
|
|
338,078 |
|
Deferred stock-based compensation |
|
|
(786 |
) |
|
|
(1,094 |
) |
Accumulated other comprehensive loss |
|
|
(54 |
) |
|
|
(75 |
) |
Deficit accumulated during the development stage |
|
|
(242,331 |
) |
|
|
(230,639 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
121,949 |
|
|
|
106,313 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
186,995 |
|
|
$ |
169,516 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The condensed balance sheet at December 31, 2006 has been derived from the audited financial
statements at that date but does not include all of the information and footnotes required by
accounting principles generally accepted in the United States of America for complete
financial statements. |
The accompanying notes are an integral part of these financial statements.
3
CYTOKINETICS, INCORPORATED
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
August 5, 1997 |
|
|
|
Three Months Ended |
|
|
(date of inception) |
|
|
|
March 31, |
|
|
March 31, |
|
|
to March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenues from related party |
|
$ |
147 |
|
|
$ |
718 |
|
|
$ |
39,012 |
|
Research and development, grant and other revenues |
|
|
|
|
|
|
2 |
|
|
|
2,955 |
|
License revenues from related parties |
|
|
3,058 |
|
|
|
700 |
|
|
|
17,159 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
3,205 |
|
|
|
1,420 |
|
|
|
59,126 |
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
|
12,486 |
|
|
|
11,266 |
|
|
|
242,587 |
|
General and administrative (1) |
|
|
4,483 |
|
|
|
3,622 |
|
|
|
73,223 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
16,969 |
|
|
|
14,888 |
|
|
|
315,810 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(13,764 |
) |
|
|
(13,468 |
) |
|
|
(256,684 |
) |
Interest and other income |
|
|
2,241 |
|
|
|
1,128 |
|
|
|
18,693 |
|
Interest and other expense |
|
|
(169 |
) |
|
|
(124 |
) |
|
|
(4,340 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,692 |
) |
|
$ |
(12,464 |
) |
|
$ |
(242,331 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common share basic and diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.36 |
) | |
|
|
|
Weighted-average number of shares used in computing
net loss per common share basic and diluted |
|
|
46,761 |
|
|
|
34,247 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes the following stock-based compensation
charges: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
644 |
|
|
$ |
556 |
|
|
$ |
6,024 |
|
General and administrative |
|
|
516 |
|
|
|
382 |
|
|
|
4,331 |
|
The accompanying notes are an integral part of these financial statements.
4
CYTOKINETICS, INCORPORATED
(A Development Stage Enterprise)
CONDENSED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
|
August 5, 1997 |
|
|
|
Three Months Ended |
|
|
(date of inception) |
|
|
|
March 31, |
|
|
March 31, |
|
|
to March 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(11,692 |
) |
|
$ |
(12,464 |
) |
|
$ |
(242,331 |
) |
Adjustments to reconcile net loss to net cash provided by (used in)
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization of property and equipment |
|
|
755 |
|
|
|
751 |
|
|
|
18,915 |
|
Loss on disposal of property and equipment |
|
|
3 |
|
|
|
|
|
|
|
338 |
|
Gain on sale of investments |
|
|
|
|
|
|
|
|
|
|
(84 |
) |
Allowance for doubtful accounts |
|
|
|
|
|
|
|
|
|
|
191 |
|
Non-cash expense related to warrants issued for equipment financing
lines and facility lease |
|
|
|
|
|
|
|
|
|
|
41 |
|
Non-cash interest expense |
|
|
23 |
|
|
|
23 |
|
|
|
358 |
|
Non-cash expense for acceleration of options |
|
|
|
|
|
|
|
|
|
|
20 |
|
Non-cash forgiveness of loan to officer |
|
|
|
|
|
|
|
|
|
|
253 |
|
Stock-based compensation |
|
|
1,160 |
|
|
|
938 |
|
|
|
10,356 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Related party accounts receivable |
|
|
41,938 |
|
|
|
526 |
|
|
|
(452 |
) |
Prepaid and other assets |
|
|
121 |
|
|
|
438 |
|
|
|
(1,954 |
) |
Accounts payable |
|
|
(490 |
) |
|
|
(332 |
) |
|
|
1,873 |
|
Accrued liabilities |
|
|
(916 |
) |
|
|
90 |
|
|
|
5,598 |
|
Related party payables and accrued liabilities |
|
|
(49 |
) |
|
|
(259 |
) |
|
|
115 |
|
Deferred revenue |
|
|
3,876 |
|
|
|
(700 |
) |
|
|
45,776 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
34,729 |
|
|
|
(10,989 |
) |
|
|
(160,987 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of investments |
|
|
(26,400 |
) |
|
|
(35,800 |
) |
|
|
(619,603 |
) |
Proceeds from sales and maturities of investments |
|
|
31,077 |
|
|
|
70,361 |
|
|
|
554,134 |
|
Purchases of property and equipment |
|
|
(1,655 |
) |
|
|
(925 |
) |
|
|
(27,983 |
) |
Proceeds from sale of property and equipment |
|
|
|
|
|
|
|
|
|
|
50 |
|
(Increase) decrease in restricted cash |
|
|
(91 |
) |
|
|
626 |
|
|
|
(6,125 |
) |
Issuance of related party notes receivable |
|
|
|
|
|
|
|
|
|
|
(1,146 |
) |
Proceeds from payments of notes receivable |
|
|
|
|
|
|
|
|
|
|
570 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
2,931 |
|
|
|
34,262 |
|
|
|
(100,103 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from initial public offering, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
94,004 |
|
Proceeds from sale of common stock to related party, net of issuance costs |
|
|
26,009 |
|
|
|
|
|
|
|
33,009 |
|
Proceeds from public offerings, net of issuance costs |
|
|
(7 |
) |
|
|
31,993 |
|
|
|
66,910 |
|
Proceeds from draw down of Committed Equity Financing Facility, net of
issuance costs |
|
|
|
|
|
|
4,944 |
|
|
|
22,504 |
|
Proceeds from other issuances of common stock |
|
|
141 |
|
|
|
52 |
|
|
|
4,387 |
|
Proceeds from issuance of preferred stock, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
133,172 |
|
Repurchase of common stock |
|
|
|
|
|
|
|
|
|
|
(68 |
) |
Proceeds from equipment financing lines |
|
|
1,743 |
|
|
|
|
|
|
|
23,696 |
|
Repayment of equipment financing lines |
|
|
(885 |
) |
|
|
(666 |
) |
|
|
(12,476 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
27,001 |
|
|
|
36,323 |
|
|
|
365,138 |
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
64,661 |
|
|
|
59,596 |
|
|
|
104,048 |
|
Cash and cash equivalents, beginning of period |
|
|
39,387 |
|
|
|
13,515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
104,048 |
|
|
$ |
73,111 |
|
|
$ |
104,048 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
5
CYTOKINETICS, INCORPORATED
(A DEVELOPMENT STAGE ENTERPRISE)
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
Note 1. Organization and Summary of Significant Accounting Policies
Overview
Cytokinetics, Incorporated (the Company, we or our) was incorporated under the laws of
the state of Delaware on August 5, 1997 to discover, develop and commercialize novel small molecule
drugs specifically targeting the cytoskeleton. The Company is a development stage enterprise and
has been primarily engaged in conducting research, developing drug candidates and product
technologies, and raising capital.
The Company has funded its operations primarily through sales of common stock and convertible
preferred stock, contract payments under its collaboration agreements, debt financing arrangements,
government grants and interest income.
The Companys registration statement for its initial public offering (IPO) was declared
effective by the Securities and Exchange Commission (SEC) on April 29, 2004. The Companys common
stock commenced trading on the NASDAQ National Market, now the NASDAQ Global Market, on April 29,
2004 under the trading symbol CYTK.
Prior to achieving profitable operations, the Company intends to continue to fund operations
through the additional sale of equity securities, payments from strategic collaborations,
government grant awards and debt financing.
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance
with accounting principles generally accepted in the United States of America for interim financial
information and with instructions to Form 10-Q and Rule 10-01
of Regulation S-X
.. Accordingly, they
do not include all of the information and footnotes required by generally accepted accounting
principles for complete financial statements. The financial statements include all adjustments
(consisting only of normal recurring adjustments) that management believes are necessary for the
fair statement of the balances and results for the periods presented. These interim financial
statement results are not necessarily indicative of results to be expected for the full fiscal year
or any future interim period.
The balance sheet at December 31, 2006 has been derived from the audited financial statements
at that date. The financial statements and related disclosures have been prepared with the
presumption that users of the interim financial statements have read or have access to the audited
financial statements for the preceding fiscal year. Accordingly, these financial statements should
be read in conjunction with the audited financial statements and notes thereto contained in the
Companys Form 10-K for the year ended December 31, 2006.
Comprehensive Loss
Comprehensive loss consists of the net loss and other comprehensive gain (loss). Other
comprehensive gain (loss) includes certain changes in stockholders equity that are excluded from
net loss. Comprehensive loss and its components for the three months ended March 31, 2007 and 2006
are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Net loss |
|
$ |
(11,692 |
) |
|
$ |
(12,464 |
) |
Change in unrealized gain (loss) on investments |
|
|
21 |
|
|
|
14 |
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(11,671 |
) |
|
$ |
(12,450 |
) |
|
|
|
|
|
|
|
6
Restricted Cash
In accordance with the terms of the Companys line of credit agreements with General Electric
Capital Corporation (GE Capital), the Company is obligated to maintain a certificate of deposit
with the lender. The balance of the certificate of deposit was $6.1 million at March 31, 2007 and
$6.0 million at December 31, 2006, and was classified as restricted cash.
Note 2. Net Loss Per Share
Basic net loss per common share is computed by dividing the net loss by the weighted-average
number of vested common shares outstanding during the period. Diluted net loss per common share is
computed by giving effect to all potentially dilutive common shares, including outstanding options,
common stock subject to repurchase, shares issuable under the
Employee Stock Purchase Plan (ESPP) and warrants. Following is a reconciliation of the numerator and
denominator used in the calculation of basic and diluted net loss per common share (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Numerator net loss |
|
$ |
(11,692 |
) |
|
$ |
(12,464 |
) |
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding |
|
|
46,763 |
|
|
|
34,276 |
|
Less: Weighted-average shares subject to repurchase |
|
|
(2 |
) |
|
|
(29 |
) |
|
|
|
|
|
|
|
Weighted-average shares used in computing basic and diluted net loss per common share |
|
|
46,761 |
|
|
|
34,247 |
|
|
|
|
|
|
|
|
The following outstanding instruments were excluded from the computation of diluted net loss
per common share for the periods presented, because their effect would have been antidilutive (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
As of March 31, |
|
|
|
2007 |
|
|
2006 |
|
Options to purchase common stock |
|
|
5,212 |
|
|
|
4,302 |
|
Common stock subject to repurchase |
|
|
|
|
|
|
24 |
|
Shares issuable related to the ESPP |
|
|
92 |
|
|
|
103 |
|
Warrants to purchase common stock |
|
|
244 |
|
|
|
294 |
|
|
|
|
|
|
|
|
Total shares |
|
|
5,548 |
|
|
|
4,723 |
|
|
|
|
|
|
|
|
Note 3. Supplemental Cash Flow Data
Supplemental cash flow data was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
|
|
|
August 5, 1997 |
|
|
Three Months Ended |
|
(date of inception) |
|
|
March 31, |
|
March 31, |
|
to March 31, |
|
|
2007 |
|
2006 |
|
2007 |
Significant non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Deferred stock-based compensation |
|
$ |
|
|
|
$ |
|
|
|
$ |
6,940 |
|
Purchases of property and equipment through accounts payable |
|
$ |
122 |
|
|
$ |
440 |
|
|
$ |
122 |
|
Purchases of property and equipment through trade in value
of disposed property and equipment |
|
$ |
|
|
|
$ |
|
|
|
$ |
258 |
|
Penalty on restructuring of equipment financing lines |
|
$ |
|
|
|
$ |
|
|
|
$ |
475 |
|
Conversion of convertible preferred stock to common stock |
|
$ |
|
|
|
$ |
|
|
|
$ |
133,172 |
|
Note 4. Related Party Agreements
Research and Development Arrangements
GlaxoSmithKline. In June 2006, the Companys Collaboration and License Agreement (the
Collaboration Agreement) with GlaxoSmithKline (GSK) was amended to extend the research term for
an additional year to facilitate continued research activities under an updated research plan
focused towards the mitotic kinesin centromere-associated protein E (CENP-E). Accordingly, the
research term with respect to all mitotic kinesins other than CENP-E expired in June 2006. Under
this amendment, GSK will have no obligation to reimburse the Company for our full-time employee
equivalents during the extension of the research term.
In November 2006, the Collaboration Agreement was further amended. Under the November 2006
amendment, the Company assumed responsibility, at its expense, for the continued research,
development and commercialization of inhibitors of kinesin spindle
7
protein (KSP), including ispinesib and SB-743921, and all other mitotic kinesins with the
exception of inhibitors of CENP-E. Under the November 2006 amendment, the Companys development of
ispinesib and SB-743921 is subject to GSKs option to resume responsibility for the development and
commercialization of either or both drug candidates during a defined period. If GSK exercises its
option for a drug candidate, it will pay the Company an option fee equal to the costs the Company
independently incurred for that drug candidate, plus a premium intended to compensate for the cost
of capital associated with such costs, subject to an agreed limit for such costs and premium. Upon
GSK exercising its option for a drug candidate, the Company may receive additional
pre-commercialization milestone payments with respect to such drug candidate and increased
royalties on net sales of any resulting product, in each case, beyond those contemplated under the
original agreement. If GSK does not exercise its option for a drug candidate, the Company will be
obligated to pay royalties to GSK on the sales of any resulting products. The November 2006
amendment supersedes a previous amendment to the collaboration agreement dated September 2005,
which specifically related to SB-743921.
GSK has the right to terminate the Collaboration Agreement on six months notice at any time.
If GSK abandons development of any drug candidate prior to regulatory approval, the Company may
undertake and fund the clinical development of that drug candidate or commercialization of any
resulting drug, may seek a new partner for such clinical development or commercialization, or
curtail or abandon such clinical development or commercialization.
For those drug candidates that GSK develops under the Collaboration Agreement, the Company can
elect to co-fund certain later-stage development activities which would increase its potential
royalty rates on sales of resulting drugs and provide the Company with the option to secure
co-promotion rights in North America. If the Company exercises its co-promotion option, then it is
entitled to receive reimbursement from GSK for certain sales force costs we incur in support of our
commercial activities.
Amgen. On December 29, 2006, the Company entered into a collaboration and option agreement
with Amgen Inc. (Amgen) to discover, develop and commercialize novel small-molecule therapeutics
that activate cardiac muscle contractility for potential applications in the treatment of heart
failure. The agreement provides Amgen with a non-exclusive license and access to certain
technology, as well as an exclusive option to participate in future development and
commercialization of CK-1827452 world-wide, excluding Japan. Under the terms of the agreement,
the Company received in January 2007, an upfront, non-refundable license and technology access fee
of $42.0 million from Amgen. The upfront fee was recorded as related party accounts receivable as
of December 31, 2006. The upfront fee is being amortized to license revenue over the maximum term
of the non-exclusive license, which is four years. Management determined that the obligations
under the non-exclusive license did not meet the requirement for separate units of accounting and
therefore should be recognized as a single unit of accounting.
During the initial research term of the collaboration and option agreement, the Company will
perform research, at its expense, as well as conduct all development activities for CK-1827452, at
its expense, in accordance with an agreed upon development plan. Amgens option is exercisable
during a defined period, the ending of which is dependent upon satisfaction of certain conditions,
primarily CK-1827452 being developed to meet pre-defined criteria in Phase IIa clinical trials
conducted during the initial research term. To exercise its option, Amgen is required to pay a
non-refundable fee of $50.0 million and thereafter would have an exclusive license. On exercise of
the option, the Company is required to transfer all data and know-how necessary to enable Amgen to
assume responsibility for development and commercialization of
CK-1827452 and related compounds,
which Amgen will perform at its sole expense. Development services, if any, performed by the
Company after commencement of the exclusive license term will be reimbursed by Amgen. Under the
terms of the agreement, the Company may be eligible to receive pre-commercialization and
commercialization milestone payments of up to $600.0 million in the aggregate on CK-1827452 and
other potential products arising from research under the collaboration as well as royalties that
escalate based on increasing levels of the annual net sales of products commercialized under the
agreement. The agreement also provides for the Company to receive increased royalties by co-funding
Phase III development costs of drug candidates under the collaboration. If the Company elects to
co-fund such costs, it would be entitled to co-promote products in North America and participate in
agreed commercial activities in institutional care settings, at Amgens expense. If Amgen elects
not to exercise its option on CK-1827452, the Company may then proceed to independently develop
CK-1827452 and the research collaboration would terminate.
In connection with entering into the collaboration and option agreement, the Company also
entered into a common stock purchase agreement (the CSPA) with Amgen. Accordingly, on January 2,
2007, the Company issued 3,484,806 shares of its common stock to Amgen under the CSPA at a price of
$9.47 per share for an aggregate purchase price of approximately $33.0 million. The common stock
was valued using the closing price of the Companys common stock on December 29, 2006, the last
trading day of the Companys common stock prior to issuance. The difference between the price paid
by Amgen of $9.47 per share and the stock price of $7.48 per share resulted in an aggregate stock
purchase premium of $6.9 million. This premium was recorded as deferred revenue and is being
amortized to license revenue ratably over the maximum term of the non-exclusive license granted to
Amgen under the
8
collaboration and option agreement, which is four years. After deducting issuance costs, the
Company received net proceeds of approximately $32.9 million from the stock issuance.
In the first quarter of 2007, the Company recognized license revenue of $3.1 million under the
collaboration and option agreement and CSPA with Amgen. At March 31, 2007, deferred revenue related
to the collaboration and option agreement and the CSPA was $45.8 million.
Other
Under the provisions of our amended collaboration and facilities agreement with Portola
Pharmaceuticals, Inc. (Portola), the Company is obligated to reimburse Portola for certain
equipment costs incurred by Portola in connection with research and related services that Portola
provides to the Company. The Company began to incur these costs when the equipment became available
for use in the second quarter of 2006. Our payments to Portola for such equipment costs, totaling
$285,000, are being made in eight quarterly installments that commenced in the first quarter of
2006 and will continue through the fourth quarter of 2007. Charles J. Homcy, M.D., is the
President and CEO of Portola, a member of the Companys Board of Directors and a consultant to the
Company.
In August 2006, the Company entered into an agreement with Portola, whereby Portola
sub-subleased approximately 2,500 square feet of office space from the Company at a monthly rate of
$1.75 per square foot. The term of the agreement commenced on August 22, 2006 and continued until
October 31, 2006, with the option to extend it on a month-to-month basis thereafter. Sublease
income from this agreement offsets rent expense. In February 2007, Portola notified the Company of
its termination of the sublease agreement effective April 30, 2007.
Note 5. Equipment Financing Lines
In April 2006, the Company secured a second line of credit with GE Capital of up to $4.6
million to finance certain equipment until December 31, 2006. In January 2007, GE Capital approved
an extension to the funding period for the April 2006 line of credit to April 28, 2007. The line
of credit is subject to the Master Security Agreement (the MSA) between the Company and GE
Capital, dated February 2001 and as amended on March 24, 2006. Under the terms of the MSA, funds
borrowed by the Company from GE Capital are collateralized by property and equipment of the Company
purchased by such borrowed funds and other collateral as agreed to by the Company. During the
first quarter of 2007, the Company borrowed $1.7 million under the line at an interest rate of
7.24% to finance purchases of property and equipment. As of March 31, 2007, additional borrowings
of $480,000 were available to the Company under this line.
Note 6. Stockholders Equity
Common Stock
In January 2007, the Company issued 3,484,806 shares of its common stock to Amgen. See Note 4
Related Party Agreements Research and Development Arrangements Amgen.
On
May 1, 2007, 90,415 shares of common stock were issued pursuant
to the ESPP at an average price of $4.57 per share.
Stock Option Plans
In January 2004, the Board of Directors adopted the 2004 Equity Incentive Plan (the 2004
Plan) which was approved by the stockholders in February 2004. The 2004 Plan provides for the
granting of incentive stock options, nonstatutory stock options, restricted stock purchase rights
and stock bonuses to employees, directors and consultants. Under the 2004 Plan, on an annual basis,
the number of authorized shares automatically increases by a number of shares equal to the lesser
of (i) 1,500,000 shares, (ii) 3.5% of the outstanding shares on such date, or (iii) an amount
determined by the Board of Directors. Accordingly, on January 1, 2007, the number of shares of
common stock authorized for issuance under the 2004 Plan was
increased by 1,500,000 shares to a total of 2,783,876
shares.
9
Stock option activity for the first quarter of 2007 under the 2004 Plan and the 1997 Stock
Option/Stock Issuance Plan was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options |
|
|
|
|
|
|
Weighted |
|
|
|
Available for |
|
|
Options |
|
|
Average Exercise |
|
|
|
Grant |
|
|
Outstanding |
|
|
Price per Share |
|
Balance at December 31, 2006 |
|
|
1,283,876 |
|
|
|
4,032,700 |
|
|
$ |
5.31 |
|
Increase in authorized shares |
|
|
1,500,000 |
|
|
|
|
|
|
|
|
|
Options granted |
|
|
(1,317,970 |
) |
|
|
1,317,970 |
|
|
$ |
6.84 |
|
Options exercised |
|
|
|
|
|
|
(43,892 |
) |
|
$ |
3.22 |
|
Options forfeited |
|
|
94,556 |
|
|
|
(94,556 |
) |
|
$ |
7.18 |
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2007 |
|
|
1,560,462 |
|
|
|
5,212,222 |
|
|
$ |
5.68 |
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value of options granted in the first quarter of 2007 was $4.63 per
share.
Note 7. Income Taxes
In June 2006, the Financial Accounting Standards Board (FASB) issued Interpretation No. 48,
Accounting for Uncertainties in Income Taxes, an interpretation of SFAS No. 109, Accounting for
Income Taxes (FIN 48). FIN 48 prescribes a comprehensive model for how companies should
recognize, measure, present and disclose in their financial statements uncertain tax positions
taken or expected to be taken on a tax return. Under FIN 48, tax positions must initially be
recognized in the financial statements when it is more likely than not the position will be
sustained upon examination by the tax authorities. Such tax positions must initially and
subsequently be measured as the largest amount of tax benefit that
has a greater than 50% likelihood of
being realized upon ultimate settlement with the tax authority assuming full knowledge of the
position and relevant facts. FIN 48 is effective for fiscal years beginning after December 15,
2006.
FIN 48 became effective for the Company on January 1, 2007. The cumulative effect of adopting
FIN 48 on January 1, 2007 has been recorded net in deferred tax assets, which resulted in no FIN 48
liability on the balance sheet. The total amount of unrecognized tax benefits as of the date of
adoption was $3.1 million. There are open statutes of limitations for taxing authorities in
federal and state jurisdictions to audit the Company for the year 2003 through the current period.
Interest and penalties are zero, and the Companys policy to account for interest and penalties in
tax expense on the income statement. Because the Company has provided a full valuation allowance
on all of its deferred tax assets, the adoption of FIN 48 had no impact on the Companys effective
tax rate. The gross amount of unrecognized tax benefits at March 31, 2007 has not changed from the
beginning of the year, and the Company does not expect any material changes in the next 12 months.
Note 8. Recent Accounting Pronouncements
In September 2006, the FASB issued Statement of Financial Accounting Standards No. 157, Fair
Value Measurements (SFAS 157). This standard defines fair value, establishes a framework for
measuring fair value in accounting principles generally accepted in the United States of America,
and expands disclosure about fair value measurements. This pronouncement applies under the other
accounting standards that require or permit fair value measurements. Accordingly, this statement
does not require any new fair value measurement. This statement is effective for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal years. The Company is
currently evaluating the requirements of SFAS 157 and has not yet determined the impact, if any, on
the financial statements.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159), which permits
entities to choose to measure many financial instruments and certain other items at fair value that
are not currently required to be measured at fair value. SFAS 159 will be effective for us on
January 1, 2008. The Company is currently evaluating the impact of adopting SFAS 159 on its
financial position, cash flows and results of operations.
Note 9. Subsequent Events
In May 2007, an employee loan totaling $101,000 including principal and interest was repaid in
full by an employee who left the Company. As of March 31, 2007, the note was classified in the
balance sheet as related party notes receivable short term portion.
10
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This discussion and analysis should be read in conjunction with our financial statements and
accompanying notes included elsewhere in this report. Operating results are not necessarily
indicative of results that may occur in future periods.
This document contains forward-looking statements that are based upon current expectations
within the meaning of the Private Securities Reform Act of 1995. We intend that such statements be
protected by the safe harbor created thereby. Forward-looking statements involve risks and
uncertainties and our actual results and the timing of events may differ significantly from the
results discussed in the forward-looking statements. Examples of such forward-looking statements
include, but are not limited to, statements about or relating to:
|
|
|
the initiation, progress, timing, scope and anticipated date of completion of clinical trials and development
for our drug candidates and potential drug candidates by ourselves, GlaxoSmithKline, or GSK, or the National
Cancer Institute, or NCI, including the expected timing of initiation of various clinical trials for our drug
candidates and potential drug candidates, the anticipated dates of data becoming available or being announced
from various clinical trials and the anticipated timing of regulatory filings; |
|
|
|
|
our plans or ability for continued research and development of drug candidates, such as CK-1827452, ispinesib or
SB-743921, or to commercialize drugs with or without a partner, including our intention to develop clinical
development and sales and marketing capabilities; |
|
|
|
|
the potential benefits of our drug candidates and potential drug candidates; |
|
|
|
|
the utility of the clinical trials programs for our drug candidates, including, but not limited to, our drug
candidates for the treatment of each of heart failure and cancer; |
|
|
|
|
issuance of shares of our common stock under our committed equity financing facility, or CEFF, with Kingsbridge
Capital Limited, or Kingsbridge; |
|
|
|
|
receipt of milestone payments, royalties and other funds from our partners under strategic alliances, such as
with Amgen Inc., or Amgen, and GSK; |
|
|
|
|
our expected roles in research, development or commercialization under our strategic alliances, such as with
Amgen and GSK; |
|
|
|
|
losses, costs, expenses and expenditures; |
|
|
|
|
the sufficiency of existing resources to fund our operations for at least the next 12 months; |
|
|
|
|
guidance concerning revenues, research and development expenses and general and administrative expenses for 2007; |
|
|
|
|
the scope and size of research and development efforts and programs; |
|
|
|
|
our ability to protect our intellectual property and avoid infringing the intellectual property rights of others; |
|
|
|
|
potential competitors and competitive products; |
|
|
|
|
capital requirements and our needs for additional financing; |
|
|
|
|
future payments under lease obligations and equipment financing lines; |
|
|
|
|
expected future sources of revenue and capital; |
|
|
|
|
our plans to obtain limited product liability insurance; |
|
|
|
|
our plans for strategic alliances; |
11
|
|
|
increasing the number of our employees and recruiting additional key personnel; and |
|
|
|
|
expected future amortization of employee stock-based compensation. |
Such forward-looking statements involve risks and uncertainties, including, but not
limited to, those risks and uncertainties relating to:
|
|
|
difficulties or delays in development, testing, obtaining regulatory
approval for, and undertaking production and marketing of our drug
candidates, including decisions by the NCI to postpone or
discontinue research or development efforts for ispinesib, or by GSK
to postpone or discontinue research and/or development efforts
relating to CENP-E; |
|
|
|
|
difficulties or delays in patient enrollment for our clinical trials; |
|
|
|
|
unexpected adverse side effects or inadequate therapeutic efficacy
of our drug candidates that could slow or prevent product approval
(including the risk that current and past results of clinical trials
or preclinical studies are not indicative of future results of
clinical trials); |
|
|
|
|
the receipt of funds by us under our strategic alliances, including those funds dependent upon Amgens
exercise of its option with respect to CK-1827452 and GSKs exercise of its option with respect to either or
both of ispinesib and SB-743921; |
|
|
|
|
activities and decisions of, and market conditions affecting, current and future strategic partners; |
|
|
|
|
our ability to obtain additional financing if necessary; |
|
|
|
|
our ability to maintain the effectiveness of current public information under our registration statement
permitting resale of securities to be issued to Kingsbridge by us under, and in connection with, the CEFF; |
|
|
|
|
changing standards of care and the introduction of products by competitors or alternative therapies for the
treatment of indications we target; |
|
|
|
|
the uncertainty of protection for our intellectual property, through patents, trade secrets or otherwise; and |
|
|
|
|
potential infringement of the intellectual property rights or trade secrets of third parties. |
In addition such statements are subject to the risks and uncertainties discussed in the
Risk Factors section and elsewhere in this document.
When used in this Quarterly Report, unless otherwise indicated, Cytokinetics, the
Company, we, our and us refers to Cytokinetics, Incorporated.
CYTOKINETICS and our logo used alone and with the mark CYTOKINETICS are registered
service marks and trademarks of Cytokinetics. Other service marks, trademarks and trade names
referred to in this Quarterly Report on Form 10-Q are the property of their respective owners.
Overview
We are a biopharmaceutical company, incorporated in Delaware in 1997, focused on
developing small molecule therapeutics for the treatment of cardiovascular diseases and cancer. Our
development efforts are directed to advancing multiple drug candidates through clinical trials to
demonstrate proof-of-concept in humans in two significant markets: heart failure and cancer. Our
drug development pipeline consists of a drug candidate for the treatment of heart failure, being
developed in both an intravenous and oral formulation, and two drug candidates and a potential drug
candidate for the treatment of cancer. Our drug candidates and potential drug candidates are all
novel small molecules that arose from our internal research programs and are directed toward the
biology of the cytoskeleton. We believe our understanding of the cytoskeleton enables us to
discover novel and potentially safer and more effective therapeutics.
12
Since our inception in August 1997, we have incurred significant net losses. As of March
31, 2007, we had an accumulated deficit of $242.3 million. We expect to incur substantial and
increasing losses for the next several years if and to the extent:
|
|
|
we advance CK-1827452 through clinical development for the
treatment of heart failure and Amgen does not exercise its
option to participate in later-stage development and
commercialization; |
|
|
|
|
we conduct continued Phase II and later-stage development
and commercialization of ispinesib, SB-743921 or GSK-923295
under our collaboration and license agreement with GSK, as
amended; |
|
|
|
|
we exercise our option to co-fund the development of GSK-923295 or of any other drug candidate
being developed by GSK under our strategic alliance; |
|
|
|
|
we exercise our option to co-promote any of the products for which we have elected co-fund
development under our strategic alliance with GSK; |
|
|
|
|
we advance other potential drug candidates into clinical trials; |
|
|
|
|
we expand our research programs and further develop our proprietary drug discovery technologies; or
|
|
|
|
|
we elect to fund development or commercialization of any drug candidate. |
We intend to pursue selective strategic alliances to enable us to maintain financial and
operational flexibility.
Cardiovascular
We have focused our cardiovascular research and development activities on heart failure,
a disease most often characterized by compromised contractile function of the heart that impacts
its ability to effectively pump blood throughout the body. We have discovered and optimized small
molecules that have the potential to improve cardiac contractility by specifically binding to and
activating cardiac myosin, a cytoskeletal protein essential for cardiac muscle contraction. We have
selected CK-1827452, a novel cardiac myosin activator for the treatment of heart failure, as a drug
candidate for further development in our cardiovascular program. The CK-1827452 clinical trials
program is planned to include Phase I and Phase II trials designed to evaluate the safety and
efficacy of both intravenous and oral CK-1827452 in a diversity of patients, including those with
stable heart failure, ischemic cardiomyopathy, impaired renal function, acutely decompensated heart
failure, and patients with chronic heart failure at increased risk for death or hospital admission
for heart failure.
CK-1827452 (intravenous)
In 2005, we initiated a first-in-humans Phase I clinical trial with CK-1827452. This
clinical trial was designed as a double-blind, randomized, placebo-controlled, dose-escalation
trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of CK-1827452
administered intravenously to normal healthy volunteers. Clinical data from this trial were
presented at the Heart Failure Society of America Meeting in September 2006. The maximum tolerated
dose, or MTD, was 0.5 mg/kg/hr for this regimen. At this dose, the six-hour infusion of CK-1827452
produced statistically significant mean increases in left ventricular ejection fraction and
fractional shortening of 6.8 and 9.2 absolute percentage points, respectively, as compared to
placebo. These increases in indices of
left ventricular function were associated with a mean prolongation of systolic ejection time
of 84 milliseconds, which was also statistically significant. These mean changes in ejection
fraction, fractional shortening and ejection time were concentration-dependent and CK-1827452
exhibited generally linear, dose-proportional pharmacokinetics across the range of doses studied.
At the MTD, CK-1827452 was well-tolerated when compared to placebo. The adverse effects at
intolerable doses in humans appeared similar to the adverse findings observed in the preclinical
safety studies which occurred at similar plasma concentrations. These effects are believed to be
related to an excess of the intended pharmacologic effect, resulting in excessive prolongation of
the systolic ejection time, and resolved promptly with discontinuation of the infusions of
CK-1827452. The Phase I clinical trial activity of CK-1827452 is consistent with results from
preclinical models that evaluated CK-1827452 in normal dogs; however, further clinical trials are
necessary to determine whether similar results will also be seen in patients with heart failure.
13
In April 2007, we initiated a Phase II clinical trials program. The first clinical trial
initiated under this program, was a Phase IIa double-blind, randomized, placebo-controlled,
dose-escalation trial designed to investigate the safety, tolerability, pharmacokinetics and
pharmacodynamic profile of CK-1827452 administered intravenously to stable heart failure patients.
In addition to the trials primary objective of evaluating the safety and tolerability of
CK-1827452, its secondary objectives were to establish a relationship between plasma concentration
and the pharmacodynamic effects of the drug candidate in stable heart failure patients.
CK-1827452 (oral)
In December 2006, we announced results from a Phase I oral bioavailability study of
CK-1827452 in healthy volunteers. We believe that these data support our current efforts to develop
a modified release oral formulation of CK-1827452 to enable late-stage clinical development of a
dosing schedule that may be suitable for the treatment of patients with chronic heart failure. This
study was designed as an open-label, four-way crossover study in ten healthy volunteers designed to
investigate the absolute bioavailability of two oral formulations (liquid and immediate-release
solid formulations) of CK-1827452 versus an intravenous dose. In addition, the effect of taking the
immediate-release solid formulation in a fed versus fasted state on CK-1827452s relative
bioavailability was also assessed. Volunteers were administered CK-1827452 at 0.125mg/kg under each
of the following four different conditions in random order:
|
|
|
a reference intravenous infusion at a constant rate over one hour; |
|
|
|
|
a liquid solution taken orally in a fasted state; |
|
|
|
|
an immediate-release solid formulation taken orally in a fasted state; and |
|
|
|
|
an immediate-release solid formulation taken orally following consumption of a standard, high-fat breakfast. |
Pharmacokinetic data from this study demonstrated oral bioavailability of approximately 100%
for each of the three conditions of oral administration. The median time to maximum plasma
concentrations after dosing was 0.5 hours for the liquid solution taken orally, 1 hour for the
immediate-release solid formulation taken in a fasted state, and 3 hours for the immediate-release
solid formulation taken after eating. We believe that the rapid and essentially complete oral
absorption observed between subjects suggests that predictable plasma levels can be achieved with
chronic oral dosing in patients with heart failure.
In the first quarter of 2007, we initiated a Phase I single-center, open-label, sequential,
parallel group clinical trial designed to evaluate the potential for certain drug-drug interactions
with CK-1827452. The trial is designed to evaluate the effects of oral ketoconazole, a strong
metabolic inhibitor of CYP3A4, on the pharmacokinetics of CK-1827452 given orally to sixteen
healthy male volunteers. If a significant pharmacokinetic interaction between CK-1827452 and
ketoconazole is identified, then a second stage of the clinical trial will be initiated. This
second stage is designed to evaluate the effects of oral diltiazem, a moderate metabolic inhibitor
of CYP3A4, on the pharmacokinetics of oral CK-1827452 in an additional cohort of eight healthy male
volunteers.
CK-1827452 is at too early a stage of development for us to predict if or when we will be
in a position to generate any revenues or material net cash flows from its commercialization. We
currently fund all research and development costs associated with this program. We recorded
research and development expenses for activities relating to our cardiovascular program of
approximately $5.6 million for the three months ended March 31, 2007, and $4.6 million for the
three months ended March 31, 2006. We anticipate that our expenditures relating to research and
development of compounds in our cardiovascular program will increase significantly as we advance
CK-1827452 through clinical development. Our expenditures will also increase if Amgen does not
exercise its option and we elect to develop CK-1827452 or related compounds independently, or if we
elect to co-fund later-stage development of CK-1827452 or other compounds in our cardiovascular
program under the collaboration following Amgens exercise of its option.
Oncology
In the first quarter of 2007, we continued to advance our oncology development programs
as both ispinesib and SB-743921 progressed in Phase II and Phase I clinical trials, respectively.
In 2006, we entered into two amendments to our collaboration and license agreement with GSK
regarding the future research, development and commercialization of ispinesib, SB-743921 and
CENP-E. In June 2006, we amended the agreement to extend the initial five-year research term of
this strategic alliance for an additional year to continue activities focused towards translational
research directed to CENP-E. In November 2006, we further amended the agreement and assumed, at our
expense, responsibility for the continued research, development and commercialization of inhibitors
of KSP, including ispinesib and SB-743921, and other mitotic kinesins, other than CENP-E.
14
Ispinesib
The oncology clinical trials program for ispinesib is a broad program consisting of nine
Phase II clinical trials and eight Phase I or Ib clinical trials evaluating the use of ispinesib in
a variety of both solid and hematologic cancers. We believe that the breadth of this clinical
trials program takes into consideration the potential for and the complexity of developing a drug
candidate such as ispinesib. We have reported Phase II clinical trial data for ispinesib in
metastatic breast, non-small cell lung, colorectal and head and neck cancers. To date, clinical
activity for ispinesib has been observed only in non-small cell lung cancer and breast cancer, with
the more robust clinical activity observed in a Phase II clinical trial evaluating ispinesib in the
treatment of patients with locally advanced or metastatic breast cancer that had failed treatment
with taxanes and anthracyclines. Under our amended collaboration and license agreement with GSK, we
intend to conduct a focused development program for ispinesib in the treatment of patients with
locally advanced or metastatic breast cancer. This program is intended to build upon the previous
data from the clinical trials conducted by GSK and the NCI, and would be designed to further define
the clinical activity profile of ispinesib in advanced breast cancer patients in preparation for
potentially initiating a Phase III clinical trial of ispinesib for the second-line treatment of
advanced breast cancer.
The Phase II clinical trials of ispinesib that are still ongoing, recently reported or
awaiting data, and that are sponsored by GSK or by the NCI, are as follows:
Breast Cancer: GSK has concluded enrollment, after enrolling 50 patients, in a two-stage,
international, Phase II, open-label, monotherapy clinical trial, evaluating the safety and efficacy
of ispinesib in the second- or third-line treatment of patients with locally advanced or metastatic
breast cancer whose disease had recurred or progressed despite treatment with anthracyclines and
taxanes. The clinical trials primary endpoint was objective response as determined using the
Response Evaluation Criteria in Solid Tumors, or RECIST criteria. The best overall responses, as
determined using the RECIST criteria, were 3 confirmed partial responses observed among the first
33 evaluable patients. The most common adverse event was Grade 4 neutropenia. In Stage I of this
clinical trial, ispinesib demonstrated sufficient anti-tumor activity to satisfy the pre-defined
efficacy criteria required to move forward to the second stage. We anticipate additional data from
Stage 2 of this clinical trial in the first half of 2007; however, we have been informed by GSK of
another confirmed partial response in one of the Stage 2 patients, for a total of 4 confirmed
partial responses among the first 47 evaluable patients.
Ovarian Cancer: GSK has concluded enrollment and all patients are off study drug in a
Phase II, open-label, monotherapy clinical trial evaluating the efficacy of ispinesib in the
second-line treatment of patients with advanced ovarian cancer previously treated with a platinum
and taxane-based regimen. The primary endpoint of this clinical trial is objective response as
determined using the RECIST criteria and blood serum levels of the tumor mass marker CA-125. We
anticipate interim data to be available at the Annual Meeting of the American Society of Clinical
Oncology, or ASCO, in June 2007.
Renal Cell Cancer: The NCI has completed enrollment and is continuing treatment in an
open label Phase II clinical trial designed to evaluate the safety and efficacy of ispinesib as a
second-line treatment in patients with renal cell cancer. The primary endpoint of this clinical
trial is objective response as determined using the RECIST criteria. We anticipate interim data to
be available from Stage 1 of this clinical trial at ASCO in June 2007.
Prostate Cancer: The NCI has concluded enrollment and all patients are off study drug in
a Phase II clinical trial evaluating ispinesib in the second-line treatment of patients with
hormone-refractory prostate cancer. The primary endpoint is objective response as determined by
blood serum levels of the tumor mass marker Prostate Specific Antigen. We anticipate interim data
from this clinical trial to be available in the first half of 2007.
Hepatocellular Cancer: The NCI has concluded enrollment and all patients are off study
drug in an open-label Phase II clinical trial evaluating ispinesib in the first-line treatment of
patients with hepatocellular cancer. The primary endpoint is objective response as determined using
the RECIST criteria. We anticipate data from Stage 1 of this clinical trial to be available in the
first half of 2007.
Melanoma:
The NCI has concluded enrollment and all patients are off study drug in an
open-label Phase II clinical trial evaluating ispinesib in the first-line treatment of patients
with melanoma who may have received adjuvant immunotherapy but no chemotherapy. The primary
endpoint is objective response as determined using the RECIST criteria. We anticipate data from
Stage 1 of this clinical trial to be available in 2007.
In addition to the Phase II clinical trials, the Phase I and Ib clinical trials of
ispinesib, sponsored by GSK through our strategic alliance, or by the NCI that are still on-going ,
or awaiting data are as follows:
15
Ispinesib with capecitabine: In the first quarter of 2007, GSK continued to
conduct a dose-escalating, Phase Ib clinical trial evaluating the safety, tolerability and
pharmacokinetics of ispinesib in combination with capecitabine. In 2006, clinical data were
presented demonstrating that the combination of ispinesib and capecitabine may have an acceptable
tolerability profile. The optimally tolerated regimen in this clinical trial was not defined;
however, the MTD of ispinesib at 18 mg/m2, administered as an intravenous
infusion every 21 days, was tolerated with therapeutic doses of capecitabine, specifically daily
oral doses of 2000 mg/m2 and 2500 mg/m2 for 14 days,
and plasma concentrations of ispinesib did not appear to be affected by the presence of
capecitabine. Dose-limiting toxicities consisted of Grade 2 rash that did not allow 75% of the
capecitabine doses to be delivered and prolonged Grade 4 neutropenia. In this clinical trial, a
total of 12 patients had a best response of stable disease as determined using the RECIST criteria.
GSK continues to treat a patient in the Phase Ib clinical trial of ispinesib in combination with
capecitabine. We anticipate data to be available in the second half of 2007.
Pediatric Solid Tumors: In the first quarter of 2007, the NCI continued a dose-finding
Phase I clinical trial in approximately 30 patients to evaluate ispinesib as monotherapy in
pediatric patients with relapsed or refractory solid tumors. This clinical trial is designed to
investigate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of ispinesib in
this patient population.
Acute Leukemias, Chronic Myelogenous Leukemia, or Advanced Myelodysplastic Syndromes:
The NCI also continues to treat patients in a Phase I clinical trial designed to evaluate the
safety, tolerability and pharmacokinetics of ispinesib on an alternative dosing schedule in adult
patients with relapsed or refractory acute leukemias, chronic myelogenous leukemia in blast crisis
or advanced myelodysplastic syndromes. We anticipate data to be available from Stage 1 of this
clinical trial in 2007.
We expect that it will take several years before we can commercialize ispinesib, if at
all. Ispinesib is at too early a stage of development for us to predict if and when we will be in a
position to generate any revenues or material net cash flows from any resulting drugs. Accordingly,
we cannot reasonably estimate when and to what extent ispinesib will generate revenues or material
net cash flows, which may vary widely depending on numerous factors, including, but not limited to,
the safety and efficacy profile of the drug, receipt of regulatory approvals, market acceptance,
then-prevailing reimbursement policies, competition and other market conditions. We have assumed
responsibility for funding the development costs associated with ispinesib pursuant to the November
2006 amendment to our collaboration and license agreement with GSK. We intend to conduct a focused
development program for ispinesib in the treatment of patients with locally advanced or metastatic
breast cancer designed to further define the clinical activity profile of ispinesib in advanced
breast cancer patients, and in preparation for potentially initiating a Phase III clinical trial of
ispinesib for the second-line treatment of advanced breast cancer. As a result of this planned
development activity, and if GSK does not exercise its option to resume responsibility for some or
all of the development and commercialization activities associated with this drug candidate, our
expenditures relating to research and development of this drug candidate will increase
significantly.
SB-743921
In the first quarter, we continued to enroll patients in a Phase I/II clinical trial of
SB-743921 in patients with non-Hodgkins lymphoma, or NHL. This Phase I/II clinical trial is an
open-label, non-randomized clinical trial designed to investigate the safety, tolerability,
pharmacokinetics and pharmacodynamic profile of SB-743921 administered as a one-hour infusion on
days 1 and 15 of a 28-day schedule, first without and then with the administration of granulocyte
colony stimulating factor, and then to assess the potential efficacy of the MTD. Interim Phase I
data from this clinical trial are anticipated to be available at ASCO in June 2007, and additional
Phase I data are anticipated to be available in the second half of 2007.
The clinical trials program for SB-743921 may proceed for several years, and we will not be in
a position to generate any revenues or material net cash flows from this drug candidate until the
program is successfully completed, regulatory approval is achieved, and a drug is commercialized.
SB-743921 is at too early a stage of development for us to predict when or if this may occur. The
November 2006 amendment to our collaboration and license agreement with GSK provides for us to fund
the future development of SB-743921 in all cancer indications subject to GSKs option to resume
responsibility for some or all development and commercialization activities. As a result of this
amendment, our expenditures relating to research and development of this drug candidate will
increase significantly.
If GSK exercises its option for either or both of ispinesib and SB-743921, it will pay us an
option fee equal to the costs we independently incurred for the development of that drug candidate,
plus a premium intended to compensate us for the cost of capital associated with such costs,
subject to an agreed limit for such costs and premium. Upon GSK exercising its option for a drug
candidate, we may receive additional pre-commercialization milestone payments with respect to such
drug candidate and increased royalties on net sales of any resulting product, in each case, beyond
those contemplated under the original agreement.
16
GSK-923295
In June 2006, we executed an amendment to our collaboration and license agreement with
GSK whereby the research term was extended for an additional year to facilitate continued research
activities under an updated research plan focused on another mitotic kinesin and novel cancer
target, CENP-E. The research term under the collaboration and license agreement with respect to all
mitotic kinesins other than CENP-E expired in June 2006. Under the 2006 amendment, GSK will have no
obligation to reimburse us for full-time employee equivalents, or FTEs, during the extension of the
research term. GSK continues to develop GSK-923295 under the agreement. GSK has completed its
regulatory filing and we anticipate that it will initiate a Phase I clinical trial for GSK-923295
in 2007.
We will receive royalties from GSKs sales of any drugs developed and commercialized
under the strategic alliance. For those drug candidates that GSK develops under the strategic
alliance, which currently includes GSK-923295 and which may include either or both of ispinesib and
SB-743921 if so elected by GSK pursuant to its option, we can elect to co-fund certain later-stage
development activities which would increase our potential royalty rates on sales of resulting drugs
and provide us with the option to secure co-promotion rights in North America. We expect that the
royalties to be paid on future sales of each of ispinesib, SB-743921 and GSK-923295 could
potentially increase to an upper-teen percentage rate based on increasing product sales and our
anticipated level of co-funding. If we exercise our co-promotion option, then we are entitled to
receive reimbursement from GSK for certain sales force costs we incur in support of our commercial
activities.
Development Risks
The successful development of all of our drug candidates is highly uncertain. We cannot
estimate with certainty or know the exact nature, timing and estimated costs of the efforts
necessary to complete the development of any of our drug candidates or the date of completion of
these development efforts. We cannot estimate with certainty any of the foregoing due to the
numerous risks and uncertainties associated with developing our drug candidates, including, but not
limited to:
|
|
the uncertainty of the timing of the initiation and completion of patient enrollment in our clinical trials; |
|
|
|
the possibility of delays in the collection of clinical trial data and the uncertainty of the timing of the
analyses of our clinical trial data after such trials have been initiated and completed; |
|
|
|
the possibility of delays in characterization, synthesis or optimization of potential drug candidates in
our cardiovascular program; |
|
|
|
delays in developing appropriate formulations of our drug candidates for clinical trial use; |
|
|
|
the uncertainty of clinical trial results; |
|
|
|
the uncertainty of obtaining FDA or other foreign regulatory agency approval required for new therapies; and |
|
|
|
the uncertainty related to the development of commercial scale manufacturing processes and qualification of
a commercial scale manufacturing facility. |
If we fail to complete the development of any of our drug candidates in a timely manner,
it could have a material adverse effect on our operations, financial position and liquidity. In
addition, any failure by us or our partners to obtain, or any delay in obtaining, regulatory
approvals for our drug candidates could have a material adverse effect on our results of
operations. A further discussion of the risks and uncertainties associated with completing our
programs on schedule, or at all, and certain consequences of failing to do so are discussed further
in the risk factors entitled We have never generated, and may never generate, revenues from
commercial sales of our drugs and we may not have drugs to market for at least several years, if
ever, Clinical trials may fail to demonstrate the desired safety and efficacy of our drug
candidates, which could prevent or significantly delay completion of clinical development and
regulatory approval and Clinical trials are expensive, time consuming and subject to delay, as
well as other risk factors.
17
Revenues
Our current revenue sources are limited, and we do not expect to generate any direct
revenue from product sales for several years. We have recognized revenues from our strategic
alliances with Amgen, GSK and AstraZeneca for license fees and contract research activities.
Charges to GSK in 2006 were based on negotiated rates intended to approximate the costs
for our FTEs performing research under the strategic alliance and our out-of-pocket expenses, which
we recorded as the related expenses were incurred. GSK paid us an upfront licensing fee, which we
recognized ratably over the strategic alliances initial five-year research term, which ended in
June 2006. We may receive additional payments from GSK upon achieving certain precommercialization
milestones. Milestone payments are non-refundable and are recognized as revenue when earned, as
evidenced by achievement of the specified milestones and the absence of ongoing performance
obligations. We record amounts received in advance of performance as deferred revenue. The revenues
recognized to date are not refundable, even if the relevant research effort is not successful.
Under the terms of our collaboration and option agreement with Amgen, we received an
upfront, non-refundable license and technology access fee of $42.0 million. In connection with
entering into the collaboration and option agreement, the Company also entered into a common stock
purchase agreement, or CSPA, with Amgen. In January 2007 we issued 3,484,806 shares of Company
common stock to Amgen for net proceeds of $32.9 million, of which the $6.9 million purchase
premium was recorded as deferred revenue. We are amortizing the upfront fee and stock premium to
license revenue ratably over the maximum term of the non-exclusive license, which is four years. We
may receive additional payments from Amgen upon achieving certain precommercialization and
commercialization milestones. Milestone payments are non-refundable and are recognized as revenue
when earned, as evidenced by achievement of the specified milestones and the absence of ongoing
performance obligations. We may also be eligible to receive reimbursement for contract development
activities subsequent to Amgens option exercise, which we will record as revenue if and when the
related expenses are incurred. We record amounts received in advance of performance as deferred
revenue.
Charges to AstraZeneca were based on negotiated rates intended to approximate the costs
for our FTEs performing research under the strategic alliance. The revenues recognized since
inception to date are not refundable. The research term of our collaboration and license agreement
with AstraZeneca expired in December 2005, and we formally terminated that agreement in August
2006.
Because a substantial portion of our revenues for the foreseeable future will depend on
achieving development and other precommercialization milestones under our strategic alliances with
GSK and Amgen, our results of operations may vary substantially from year to year.
We expect that our future revenues will most likely be derived from royalties on sales
from drugs licensed to GSK or Amgen under our strategic alliances and from those licensed to future
partners, as well as from direct sales of our drugs. If Amgen exercises its option, we will retain
a product-by-product option to co-fund certain later-stage development activities under that
strategic alliance with Amgen, thereby potentially increasing our royalties and affording us
co-promotion rights in North America. For those products being developed by GSK under our strategic
alliance, we also retain a product-by-product option to co-fund certain later-stage development
activities, thereby potentially increasing our royalties and affording us co-promotion rights in
North America. In the event we exercise our co-promotion rights under either collaboration
agreement, we are entitled to receive reimbursement for certain sales force costs we incur in
support of our commercial activities.
Research and Development
We incur research and development expenses associated with both partnered and unpartnered
research activities, as well as the development and expansion of our drug discovery technologies.
Research and development expenses related to our strategic alliance with GSK consisted primarily of
costs related to research and screening, lead optimization and other activities relating to the
identification of compounds for development as mitotic kinesin inhibitors for the treatment of
cancer. Prior to June 2006, certain of these costs were reimbursed by GSK on an FTE basis. From
2001 through November 2006, GSK funded the majority of the costs related to the clinical
development of ispinesib and SB-743921. Under our November 2006 amendment to the collaboration and
license agreement with GSK, we assumed responsibility for the continued research, development and
commercialization of inhibitors of KSP, including ispinesib and SB-743921, and other mitotic
kinesins, at our sole expense subject to GSKs option to resume responsibility for the development
and commercialization of either or both of ispinesib and SB-743921 during a defined period. We also
have the option to co-fund certain later-stage development activities for GSK-923295. This
commitment and the potential exercise of our co-funding option will result in a significant
increase in research and development expenses. We expect to incur research and development expenses
in the continued conduct of preclinical studies and clinical trials for CK-1827452 and other of our
cardiac myosin activator compounds for the treatment of heart failure and in connection with our
early research programs in other
18
diseases, as well as the continued refinement and application of
our existing and future proprietary drug discovery technologies. Research and development expenses
related to any development and commercialization activities we elect to fund would consist
primarily of employee compensation, supplies and materials, costs for consultants and contract
research, facilities costs and depreciation of equipment. From our inception through March 31,
2007, we incurred costs of approximately $55.5 million for research and development activities
relating to the discovery of mitotic kinesin inhibitors, $87.2 million for our cardiac
contractility program, $47.1 million for our proprietary technologies and $52.8 million for all
other programs.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees in
executive and administrative functions, including, but not limited to, finance, human resources,
legal, business and commercial development and strategic planning. Other significant costs include
facilities costs and professional fees for accounting and legal services, including legal services
associated with obtaining and maintaining patents. We anticipate continued increases in general and
administrative expenses associated with operating as a publicly traded company.
Stock Compensation
The following table summarizes stock-based compensation related to employee stock options and
employee stock purchases for the three months ended March 31, 2007 and March 31, 2006, which was
allocated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, 2007 |
|
|
March 31, 2006 |
|
Research and development |
|
$ |
644 |
|
|
$ |
556 |
|
General and administrative |
|
|
516 |
|
|
|
382 |
|
|
|
|
|
|
|
|
Stock-based compensation included in operating expenses |
|
$ |
1,160 |
|
|
$ |
938 |
|
As of March 31, 2007, there was $13.0 million of total unrecognized compensation cost related
to non-vested stock-based compensation arrangements granted under the Companys stock option plans.
That cost is expected to be recognized over a weighted-average period of 3.1 years. In addition, we
continue to amortize deferred stock-based compensation recorded prior to adoption of Statement of
Financial Accounting Standards No. 123R, or SFAS 123R, for stock options granted prior to the
initial public offering. At March 31, 2007, the balance of deferred stock based compensation was
$786,000, which we expect to be amortized in future years as follows, assuming no cancellations of
the related stock options: $452,000 in the remainder of 2007 and $334,000 in 2008.
Interest and Other Income and Expense
Interest and other income and expense consist primarily of interest income and interest
expense. Interest income is primarily generated from our cash, cash equivalents and investments.
Interest expense generally relates to the borrowings under our equipment financing lines.
Results of Operations
Revenues
We recorded total revenues of $3.2 million in the first quarter of 2007 compared with total
revenues of $1.4 million in the first quarter of 2006. Revenues for the first quarter of 2007 were
largely derived from our research collaboration with Amgen, and revenues for the first quarter of
2006 were largely derived from our collaboration with GSK. The increase in revenues in 2007 was
primarily due to recognition of $3.1 million of license revenue related to the Amgen collaboration
and option agreement and the premium on the stock purchase under the CSPA. This increase was
partially offset by a decrease in revenues from GSK of $1.3 million.
Research and development revenues from a related party refers to revenues from our partner,
GSK, which is also a stockholder of the Company. Research and development revenues from GSK were
$147,000 in the first quarter of 2007 and represented patent expense reimbursements from GSK.
Research and development revenues from GSK were $718,000 in the first quarter of 2006, and
primarily consisted of $683,000 for FTE reimbursements. There were no FTE reimbursements from GSK
in 2007.
19
License revenues from related parties represents license revenue from our strategic alliances
with Amgen and GSK. The license revenue from Amgen for the first quarter of 2007 was $3.1 million
and represented amortization of the upfront license fee and the premium paid on the common stock
purchase. As of March 31, 2007, the remaining balance of deferred revenue relating to the upfront
license fee and stock purchase premium paid by Amgen was $45.8 million. We are amortizing the Amgen
deferred revenue on a straight line basis over the maximum term of the non-exclusive license
granted to Amgen under the collaboration and option agreement, which is four years. License
revenue from GSK was zero in the first quarter of 2007 and $700,000 in the first quarter of 2006.
The license revenue from GSK was amortized on a straight line basis over the initial five-year
research term, which ended on June 30, 2006.
We anticipate total revenues for the year ending December 31, 2007 to be in the range of $11.0
million to 13.0 million, which reflects license revenue and other collaboration revenue.
Research and Development Expenses
Research and development expenses were $12.5 million first quarter of 2007, up from $11.3
million in the first quarter of 2006. The increase in the first quarter of 2007 compared to the
first quarter of 2006 was primarily due to an increase of $818,000 for clinical and preclinical
outsourcing costs as we advanced our drug candidates for the treatment of cardiovascular disease
and cancer through clinical trials, as well as an increase of $352,000 for compensation and
benefits related costs.
From a program perspective, the increase in spending in the first quarter of 2007 compared to
the first quarter of 2006 was primarily due to an increase of approximately $1.1 million for
expenditures related to our early research programs and an increase of approximately $1.0 million
for the advancement of our cardiac contractility program. These increases were partially offset by
a decrease of $828,000 in spending for mitotic kinesin inhibitors. Spending for proprietary
technologies remained approximately the same.
Research and development expenses incurred related to the following programs (in millions):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2007 |
|
|
2006 |
|
Mitotic kinesin inhibitors |
|
$ |
1.0 |
|
|
$ |
1.9 |
|
Cardiac contractility |
|
|
5.6 |
|
|
|
4.6 |
|
Proprietary technologies |
|
|
1.2 |
|
|
|
1.2 |
|
All other research programs |
|
|
4.7 |
|
|
|
3.6 |
|
|
|
|
|
|
|
|
Total research and development expenses |
|
$ |
12.5 |
|
|
$ |
11.3 |
|
|
|
|
|
|
|
|
Clinical timelines, likelihood of success and total completion costs vary significantly for
each drug candidate and are difficult to estimate. We anticipate that we will make determinations
as to which early research programs to pursue and how much funding to direct to each program on an
ongoing basis in response to the scientific and clinical success of each drug candidate. The
lengthy process of seeking regulatory approvals and subsequent compliance with applicable
regulations requires the expenditure of substantial resources. Any failure by us to obtain and
maintain, or any delay in obtaining, regulatory approvals could cause our research and development
expenditures to increase and, in turn, could have a material adverse effect on our results of
operations.
We expect research and development expenditures to continue to increase in 2007. We expect to
advance research and development of our drug candidate CK-1827452. Additionally, we intend to
initiate a Phase I/II clinical trial for ispinesib in 2007 for the first-line treatment of locally
advanced or metastatic breast cancer. We also intend to continue our Phase I/II clinical trial for
SB-743921 for non-Hodgkins lymphoma. We anticipate research and development expenses to be in the
range of $70.0 million to $75.0 million for the year ending December 31, 2007.
General and Administrative Expenses
General and administrative expenses were $4.5 million in the first quarter 2007 compared with
$3.6 million for the first quarter of 2006. The increase in the first quarter of 2007 compared to
the first quarter of 2006 was primarily due an increase of $388,000 for accounting and legal fees,
as well as an increase of $342,000 for compensation and benefits related expenses.
We expect that general and administrative expenses will continue to increase during 2007 due
to increasing payroll-related expenses in support of our initial precommercialization efforts,
business development costs, expanding operational infrastructure, and
20
costs associated with being
a public company. We anticipate general and administrative expenses to be the range of $17.0
million to $19.0 million for the year ending December 31, 2007.
Interest and Other Income and Expense
Interest and other income was $2.2 million for the first quarter of 2007 compared with $1.1
million in the first quarter of 2006. The increase in the first quarter of 2007 over the first
quarter of 2006 was primarily due to higher interest income, resulting from higher average balances
of cash, cash equivalents and short-term investments, and, to a lesser extent, from higher market
interest rates earned on these investments.
Interest and other expense was $169,000 in the first quarter 2007 and $124,000 in the first
quarter of 2006. Interest and other expense in both of these periods primarily consisted of
interest expense on our equipment financing line of credit.
Critical Accounting Policies
The accounting policies that we consider to be our most critical (those that are most
important to the portrayal of our financial condition and results of operations and that require
our most difficult, subjective or complex judgments), the effects of those accounting policies
applied and the judgments made in their application are summarized in Item 7Managements
Discussion and Analysis of Financial Condition and Results of OperationsCritical Accounting
Policies and Estimates in our Annual Report on Form 10-K for the fiscal year ended December 31,
2006.
Recent Accounting Pronouncements
We adopted Interpretation No. 48, Accounting for Uncertainties in Income Taxes, an
interpretation of SFAS No. 109, Accounting for Income Taxes, or FIN 48, on January 1, 2007. The
cumulative effect of adopting FIN 48 was recorded net in deferred tax assets, which resulted in no
FIN 48 liability on the balance sheet. The total amount of unrecognized tax benefits as of the
date of adoption was $3.1 million.
In September 2006, the Financial Accounting Standards Board, or FASB, issued Statement of
Financial Accounting Standards No. 157, Fair Value Measurements, or SFAS 157. This standard
defines fair value, establishes a framework for measuring fair value in accounting principles
generally accepted in the United States of America, and expands disclosure about fair value
measurements. This pronouncement applies under the other accounting standards that require or
permit fair value measurements. Accordingly, this statement does not require any new fair value
measurement. This statement is effective for fiscal years beginning after November 15, 2007, and
interim periods within those fiscal years. We are currently evaluating the requirements of SFAS 157
and have not yet determined the impact, if any, on the financial statements.
In February 2007, the FASB issued Statement of Financial Accounting Standards No. 159, The
Fair Value Option for Financial Assets and Financial Liabilities, or SFAS 159, which permits
entities to choose to measure many financial instruments and certain other items at fair value that
are not currently required to be measured at fair value. SFAS 159 will be effective for us on
January 1, 2008. We are evaluating the impact of adopting SFAS 159 on our financial position, cash
flows and results of operations.
Liquidity and Capital Resources
From August 5, 1997, our date of inception, through March 31, 2007, we funded our operations
through the sale of equity securities, equipment financings, non-equity payments from
collaborators, government grants and interest income.
Our cash, cash equivalents and investments, excluding restricted cash, totaled $169.5 million
at March 31, 2007, an increase of $60.0 million compared with $109.5 million at December 31, 2006.
The increase was primarily due to the receipt of the upfront license fee of $42.0 million from
Amgen in January 2007, which was recorded as a related party
account receivable as of December 31,
2006, and the net proceeds of $32.9 million from the issuance of common stock to Amgen in January
2007, of which $6.9 million was recorded as deferred revenue. The increases were partly offset by
the use of cash to fund operations.
We
have received net proceeds from the sale of equity securities of
$304.0 million from August
5, 1997, the date of our inception, through March 31, 2007, excluding sales of equity to GSK and
Amgen. Included in these proceeds are $94.0 million received upon closing of the initial public
offering of our common stock in May 2004. In connection with our 2001 collaboration and license
agreement, GSK made a $14.0 million equity investment in the Company. GSK made additional equity
investments in the Company in 2003 and 2004 of $3.0 million and $7.0 million, respectively.
21
In 2005, we entered into a committed equity financing facility, or CEFF, with Kingsbridge,
pursuant to which Kingsbridge committed to finance up to $75.0 million of capital for the following
three years. Subject to certain conditions and limitations, from time to time under the CEFF, at
our election, Kingsbridge will purchase newly-issued shares of our common stock at a price that is
between 90% and 94% of the volume weighted average price on each trading day during an eight day,
forward-looking pricing period. The maximum number of shares we may issue in any pricing period is
the lesser of 2.5% of our market capitalization immediately prior to the commencement of the
pricing period or $15.0 million. The minimum acceptable volume weighted average price for
determining the purchase price at which our stock may be sold in any pricing period is determined
by the greater of $3.50 or 85% of the closing price for our common stock on the day prior to the
commencement of the pricing period. As part of the arrangement, we issued a warrant to Kingsbridge
to purchase 244,000 shares of our common stock at a price of $9.13 per share, which represents a
premium over the closing price of our common stock on the date we entered into the CEFF. This
warrant is exercisable beginning six months after the date of grant and for a period of five years
thereafter. Under the terms of the CEFF, the maximum number of shares we may sell is 5,703,488
(exclusive of the shares underlying the warrant) which, under the rules of the National Association
of Securities Dealers, Inc., is approximately the maximum number of shares we may sell to
Kingsbridge without approval of our stockholders. This limitation may further limit the amount of
proceeds we are able to obtain from the CEFF. We are not obligated to sell any of the $75.0 million
of common stock available under the CEFF and there are no minimum commitments or minimum use
penalties. The CEFF does not contain any restrictions on our operating activities, any automatic
pricing resets or any minimum market volume restrictions. In 2006, we received gross proceeds of
$17.0 million from the drawdown of 2,740,735 shares of common stock pursuant to our CEFF. In 2005,
we received gross proceeds of $5.7 million from the draw down and sale of 887,576 shares of common
stock to Kingsbridge before offering costs of $178,000.
In January 2006, we entered into a stock purchase agreement with certain institutional
investors relating to the issuance and sale of 5,000,000 shares of our common stock at a price of
$6.60 per share, for gross offering proceeds of $33.0 million. In connection with this offering, we
paid an advisory fee to a registered broker-dealer of $1.0 million. After deducting the advisory
fee and the offering costs, we received net proceeds of approximately $32.0 million from the
offering.
In December 2006, we entered into stock purchase agreements with selected institutional
investors relating to the issuance and sale of 5,285,715 shares of our common stock at a price of
$7.00 per share, for gross offering proceeds of $37.0 million. In connection with this offering, we
paid placement agent fees to three registered broker-dealers totaling $1.9 million. After deducting
the placement agent fees and the offering costs, we received net proceeds of approximately $34.9
million from the offering.
In connection with our entry into the collaboration and option agreement with Amgen, we
entered into a common stock purchase agreement under which Amgen purchased 3,484,806 shares of our
common stock at a price per share of $9.47, including a premium of $1.99 per share, and an
aggregate purchase price of approximately $33.0 million. After deducting the offering costs, we
received net proceeds of approximately $32.9 million. These shares were issued, and the related
proceeds received, in January 2007.
As of March 31, 2007, we have received $53.0 million in non-equity payments from GSK and $42.0
million in non-equity payments from Amgen.
Under equipment financing arrangements, we received $1.7 million in the first quarter of 2007,
and $23.7 million from August 5, 1997, the date of our inception, through March 31, 2007. Interest
earned on investments, excluding non-cash amortization of purchase
premiums, was $1.2 in the first quarter of 2007, and $20.0 million from August 5, 1997, the
date of our inception, through March 31, 2007.
Net cash provided by operating activities in the first quarter of 2007 was $34.7 million and
primarily resulted from the payment by Amgen in January 2007 of the $42.0 million upfront,
non-refundable license and technology access fee under the collaboration and license agreement
entered into in December 2006, and the $6.9 million premium stock purchase premium paid by Amgen,
which was recorded as deferred revenue. Partially offsetting these sources of cash were the
Companys net loss of $11.7 million, and the amortization of deferred revenue of $3.1 million.
Deferred revenue increased $3.9 million in the first quarter of 2007 to $45.8 million at March
31, 2007 from $41.9 million at December 31, 2006. The increase was due to the $6.9 million premium
paid by Amgen for its purchase of 3,484,806 shares of our common stock in January 2007 under the
CSPA, which was partly offset by the amortization in the first quarter of 2007 of Amgen license
revenue of $3.1 million related to the collaboration and license agreement and the CSPA.
22
Net cash provided by investing activities was $2.9 million in the first quarter of 2007 and
primarily represented the net proceeds from the maturity of investments and the purchase of
investments of $4.7 million, partly offset by funds used to purchase property and equipment of $1.7
million. Restricted cash totaled $6.1 million at March 31, 2007, up slightly from $6.0 million at
December 31, 2006.
Net cash provided by financing activities of $27.0 million in the first quarter of 2007
primarily represented net proceeds of approximately $32.9 million from the issuance of common stock
to Amgen, less $6.9 million that was recorded as deferred revenue, along with the net impact of
equipment line financing activities of $858,000. In March 2007 we drew down approximately $1.7
million in additional borrowings under the April 2006 equipment line of credit with General
Electric Capital Corporation, or GE Capital. As of March 31, 2007, additional borrowings of
$480,000 were available to us under the line. The equipment line is subject to the Master Security
Agreement, or MSA, between us and GE Capital, dated February 2001, as amended on March 24, 2006.
Under the terms of the MSA, funds borrowed by us from GE Capital are collateralized by our property
and equipment purchased by such borrowed funds and other collateral as agreed to by us. In
connection with each line of credit, we are obligated to maintain a certificate of deposit with the
lender.
As of March 31, 2007, future minimum payments under lease obligations and equipment financing
lines were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Within |
|
|
Two to |
|
|
Four to |
|
|
After |
|
|
|
|
|
|
One Year |
|
|
Three Years |
|
|
Five Years |
|
|
Five Years |
|
|
Total |
|
Operating leases |
|
$ |
3,167 |
|
|
$ |
6,250 |
|
|
$ |
5,584 |
|
|
$ |
2,814 |
|
|
$ |
17,815 |
|
Equipment financing line |
|
|
4,039 |
|
|
|
5,467 |
|
|
|
2,152 |
|
|
|
35 |
|
|
|
11,693 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
7,206 |
|
|
$ |
11,717 |
|
|
$ |
7,736 |
|
|
$ |
2,849 |
|
|
$ |
29,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our long-term commitments under operating leases relate to payments under our two facility
leases in South San Francisco, California, which expire in 2011 and 2013.
Under the provisions of our amended agreement with Portola Pharmaceuticals, Inc., or Portola,
we are obligated to reimburse Portola for certain equipment costs incurred by Portola in connection
with research and related services that Portola provides to us. We began to incur these costs when
the equipment became available for use in the second quarter of 2006. Our payments to Portola for
such equipment costs, totaling $285,000, are scheduled to be made in eight quarterly installments
commencing in the first quarter of 2006 and continuing through the fourth quarter of 2007.
In future periods, we expect to incur substantial costs as we continue to expand our research
programs and related research and development activities. We also plan to conduct clinical
development of ispinesib for breast cancer and SB-743921 for non-Hodgkins lymphoma. We expect to
incur significant research and development expenses as we advance the research and development of
our cardiac myosin activators for the treatment of heart failure, continue human clinical trials of
CK-1827452 in 2007, pursue our other early stage research programs in multiple therapeutic areas
and continue to refine and apply our existing and future proprietary drug discovery technologies.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include, but are not limited to, the following:
|
|
|
the initiation, progress, timing, scope and completion of preclinical research,
development and clinical trials for our drug candidates and potential drug candidates; |
|
|
|
|
the time and costs involved in obtaining regulatory approvals; |
|
|
|
|
delays that may be caused by requirements of regulatory agencies; |
|
|
|
|
Amgens decisions with regard to funding of development and commercialization of
CK-1827452 or other compounds for the treatment of heart failure under our collaboration; |
|
|
|
|
GSKs decisions with regard to future funding of development of our drug candidates,
including GSK-923295 and, if it exercises its option, either or both of ispinesib and
SB-743921; |
|
|
|
|
our level of funding for the development of current or future drug candidates; |
23
|
|
|
the number of drug candidates we pursue; |
|
|
|
|
the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; |
|
|
|
|
our ability to establish, enforce and maintain selected strategic alliances and
activities required for commercialization of our potential drugs; |
|
|
|
|
our plans or ability to establish sales, marketing or manufacturing capabilities and to
achieve market acceptance for potential drugs; |
|
|
|
|
expanding and advancing our research programs; |
|
|
|
|
hiring of additional employees and consultants; |
|
|
|
|
expanding our facilities; |
|
|
|
|
the acquisition of technologies, products and other business opportunities that require financial commitments; and |
|
|
|
|
our revenues, if any, from successful development of our drug candidates and commercialization of potential drugs. |
We believe that our existing cash and cash equivalents and short-term investments, future
payments from Amgen and GSK, interest earned on investments, proceeds from equipment financings and
the potential proceeds from the CEFF will be sufficient to meet our projected operating
requirements for at least the next 12 months. If, at any time, our prospects for internally
financing our research and development programs decline, we may decide to reduce research and
development expenses by delaying, discontinuing or reducing our funding of development of one or
more of our drug candidates or potential drug candidates. Alternatively, we might raise funds
through public or private financings, strategic relationships or other arrangements. There can be
no assurance that the funding, if needed, will be available on attractive terms, or at all.
Furthermore, any additional equity financing may be dilutive to stockholders and debt financing, if
available, may involve restrictive covenants. Similarly, financing obtained through future
co-development arrangements may require us to forego certain commercial rights to future drug
candidates. Our failure to raise capital as and when needed could have a negative impact on our
financial condition and our ability to pursue our business strategy.
Off-balance Sheet Arrangements
As of March 31, 2007, we did not have any relationships with unconsolidated entities or
financial partnerships, such as entities often referred to as structured finance or special purpose
entities, which would have been established for the purpose of facilitating off-balance sheet
arrangements or other contractually narrow or limited purposes. In addition, we do not engage in
trading activities involving non-exchange traded contracts. Therefore, we are not materially
exposed to financing, liquidity, market or credit risk that could arise if we had engaged in these
relationships. We do not have relationships or transactions with persons or entities that derive
benefits from their non-independent relationship with us or our related parties.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk has not changed materially subsequent to our disclosures in Item
7A, Quantitative and Qualitative Disclosures About Market Risk in our Annual Report on Form 10-K
for the year ended December 31, 2006.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of disclosure controls and procedures
Our management evaluated, with the participation and under the supervision of our Chief
Executive Officer and our Chief Financial Officer, the effectiveness of our disclosure controls and
procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this
evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded, subject to
the limitations described below, that our disclosure controls and procedures are effective to
ensure that information we are required to disclose in reports that we file or submit under the
Securities Exchange Act of 1934 is recorded, processed, summarized and
24
reported within the time
periods specified in Securities and Exchange Commission rules and forms, and that such information
is accumulated and communicated to management as appropriate to allow timely decisions regarding
required disclosures.
(b) Changes in internal control over financial reporting
There was no change in our internal control over financial reporting that occurred during the
period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
(c) Limitations on the Effectiveness of Controls
A control system, no matter how well conceived and operated, can provide only reasonable, not
absolute, assurance that the objectives of the controls are met. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that
all control issues, if any, within a company have been detected. Accordingly, our disclosure
controls and procedures are designed to provide reasonable, not absolute, assurance that the
objectives of our disclosure control system are met.
25
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
Our future operating results may vary substantially from anticipated results due to a number
of factors, many of which are beyond our control. The following discussion highlights some of these
factors and the possible impact of these factors on future results of operations. You should
carefully consider these factors before making an investment decision. If any of the following
factors actually occur, our business, financial condition or results of operations could be harmed.
In that case, the price of our common stock could decline, and you could experience losses on your
investment.
Risks Related To Our Business
Our drug candidates are in the early stages of clinical testing and we have a history of
significant losses and may not achieve or sustain profitability and, as a result, you may lose
all or part of your investment.
Our drug candidates are in the early stages of clinical testing and we must conduct
significant additional clinical trials before we can seek the regulatory approvals necessary to
begin commercial sales of our drugs. We have incurred operating losses in each year since our
inception in 1997 due to costs incurred in connection with our research and development activities
and general and administrative costs associated with our operations. We expect to incur increasing
losses for at least several years, as we continue our research activities and conduct development
of, and seek regulatory approvals for, our drug candidates, and commercialize any approved drugs.
If our drug candidates fail in clinical trials or do not gain regulatory approval, or if our drugs
do not achieve market acceptance, we will not be profitable. If we fail to become and remain
profitable, or if we are unable to fund our continuing losses, you could lose all or part of your
investment.
We have never generated, and may never generate, revenues from commercial sales of our drugs and
we may not have drugs to market for at least several years, if ever.
We currently have no drugs for sale and we cannot guarantee that we will ever have marketable
drugs. We must demonstrate that our drug candidates satisfy rigorous standards of safety and
efficacy to the U.S. Food and Drug Administration, or FDA, and other regulatory authorities in the
United States and abroad. We and our partners will need to conduct significant additional research
and preclinical and clinical testing before we or our partners can file applications with the FDA
or other regulatory authorities for approval of our drug candidates. In addition, to compete
effectively, our drugs must be easy to use, cost-effective and economical to manufacture on a
commercial scale, compared to other therapies available for the treatment of the same conditions.
We may not achieve any of these objectives. CK-1827452, our drug candidate for the treatment of
heart failure, ispinesib, our most advanced drug candidate for the treatment of cancer and
SB-743921, our second drug candidate for the treatment of cancer, are currently our only drug
candidates in clinical trials and we cannot be certain that the clinical development of these or
any future drug candidate will be successful, that they will receive the regulatory approvals
required to commercialize them, or that any of our other research programs will yield a drug
candidate suitable for entry into clinical trials. Our commercial revenues, if any, will be derived
from sales of drugs that we do not expect to be commercially available for several years, if at
all. The development of any one or all of these drug candidates may be discontinued at any stage of
our clinical trials programs and we may not generate revenue from any of these drug candidates.
We currently finance and plan to continue to finance our operations through the sale of equity,
potentially entering into additional strategic alliances and obtaining debt financings, which
may result in additional dilution to our stockholders or relinquishment of valuable technology
rights or the imposition of restrictive covenants, or may cease to be available on attractive
terms or at all.
We have funded all of our operations and capital expenditures with proceeds from both private
and public sales of our equity securities, strategic alliances with GSK, Amgen, AstraZeneca and
others, equipment financings, interest on investments and government grants. We believe that our
existing cash and cash equivalents, future payments from GSK and Amgen, interest earned on
investments, proceeds from equipment financings and potential proceeds from our CEFF with
Kingsbridge will be sufficient to meet our projected operating requirements for at least the next
12 months. To meet our future cash requirements, we may raise funds
26
through public or private equity offerings, strategic alliances or debt financings. To the
extent that we raise additional funds by issuing equity securities, our stockholders may experience
additional dilution. To the extent that we raise additional funds through strategic alliance and
licensing arrangements, we will likely have to relinquish valuable rights to our technologies,
research programs or drug candidates, or grant licenses on terms that may not be favorable to us.
To the extent that we raise additional funds through debt financing, if available, such financing
may involve covenants that restrict our business activities. In addition, there can be no assurance
that any such funding, if needed, will be available on favorable terms, or at all. If we can not
raise the funds we need on favorable terms, or at all, our ability to conduct our business will be
significantly harmed and our stock price could be negatively affected.
Clinical trials may fail to demonstrate the desired safety and efficacy of our drug candidates,
which could prevent or significantly delay completion of clinical development and regulatory
approval.
Prior to receiving approval to commercialize any of our drug candidates, we must demonstrate
with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA
and other regulatory authorities in the United States and abroad, that such drug candidate is both
sufficiently safe and effective. In clinical trials we will need to demonstrate efficacy for the
treatment of specific indications and monitor safety throughout the clinical development process.
None of our drug candidates have yet been demonstrated to be safe and effective in clinical trials
and there is no assurance that they will. In addition, for each of our current preclinical
compounds, we must demonstrate satisfactory chemistry, formulation, stability and toxicity in order
to file an investigational new drug application, or IND, that would allow us to advance that
compound into clinical trials. If our preclinical studies, current clinical trials or future
clinical trials are unsuccessful, our business and reputation will be significantly harmed and our
stock price could be negatively affected.
All of our drug candidates are prone to the risks of failure inherent in drug development.
Preclinical studies may not yield results that would satisfactorily support the filing of an IND
(or a foreign equivalent) with respect to our potential drug candidates. Even if these applications
would be or have been filed with respect to our drug candidates, the results of preclinical studies
do not necessarily predict the results of clinical trials. For example, although preclinical
testing indicated that ispinesib causes tumor regression in a variety of tumor types, to date Phase
II clinical trials of ispinesib have not shown clinical activity in colorectal cancer or in
recurrent or metastatic head and neck squamous cell carcinoma. Similarly, early-stage clinical
trials in healthy volunteers do not necessarily predict the results of later-stage clinical trials,
including the safety and efficacy profiles of any particular drug candidate. In addition, there can
be no assurance that the design of the clinical trials for any of our drug candidates is focused on
appropriate indications, tumor types, patient populations, dosing regimens or other variables which
will result in obtaining the desired efficacy data to support regulatory approval to commercialize
the drug. For example, in a two-stage Phase II clinical trial designed to evaluate the safety and
efficacy of ispinesib as monotherapy in the second-line treatment of patients with either
platinum-sensitive or platinum-refractory non-small cell lung cancer, ispinesib did not satisfy the
criteria for advancement to Stage 2 in either treatment arm. Even if we believe the data collected
from clinical trials of our drug candidates are promising, such data may not be sufficient to
support approval by the FDA or any other U.S. or foreign regulatory authority. Preclinical and
clinical data can be interpreted in different ways. Accordingly, FDA officials or officials from
foreign regulatory authorities could interpret the data in different ways than we or our partners
do, which could delay, limit or prevent regulatory approval.
Administering any of our drug candidates or potential drug candidates may produce undesirable
side effects, also known as adverse effects. Toxicities and adverse effects that we have observed
in preclinical studies for some compounds in a particular research and development program may
occur in preclinical studies or clinical trials of other compounds from the same program. Potential
toxicity issues may arise from the effects of the active pharmaceutical ingredient, or API, itself
or from impurities or degradants that are present in the API or could form over time in the
formulated drug candidate or the API. Such toxicities or adverse effects could delay or prevent the
filing of an IND (or a foreign equivalent) with respect to such drug candidates or potential drug
candidates or cause us to cease clinical trials with respect to any drug candidate. In clinical
trials, administering any of our drug candidates to humans may produce adverse effects. For
example, in clinical trials of ispinesib, the dose-limiting toxicity was neutropenia, a decrease in
the number of a certain type of white blood cell that results in an increase in susceptibility to
infection. In a Phase I clinical trial of SB-743921, the dose-limiting toxicities observed were:
prolonged neutropenia, with or without fever and with or without infection; elevated transaminases
and hyperbilirubinemia, both of which are abnormalities of liver function; and hyponatremia, which
is a low concentration of sodium in the blood. In a Phase I clinical trial of CK-1827452,
intolerable doses of CK-1827452 were associated with complaints of chest discomfort, palpitations,
dizziness and feeling hot, increases in heart rate, declines in blood pressure,
electrocardiographic changes consistent with acute myocardial ischemia and transient rises in
cardiac troponins I and T, which are markers of possible myocardial injury. These adverse effects
could interrupt, delay or halt clinical trials of our drug candidates and could result in the FDA
or other regulatory authorities denying approval of our drug candidates for any or all targeted
indications. The FDA, other regulatory authorities, our partners or we may suspend or terminate
clinical trials at any time. Even if one or more of our
27
drug candidates were approved for sale, the occurrence of even a limited number of toxicities
or adverse effects when used in large populations may cause the FDA to impose restrictions on, or
stop, the further marketing of such drugs. Indications of potential adverse effects or toxicities
which may occur in clinical trials and which we believe are not significant during the course of
such clinical trials may later turn out to actually constitute serious adverse effects or
toxicities when a drug has been used in large populations or for extended periods of time. Any
failure or significant delay in completing preclinical studies or clinical trials for our drug
candidates, or in receiving and maintaining regulatory approval for the sale of any drugs resulting
from our drug candidates, may significantly harm our reputation and business and negatively affect
our stock price.
Clinical trials are expensive, time consuming and subject to delay.
Clinical trials are very expensive and difficult to design and implement, especially in the
heart failure and cancer indications that we are pursuing, in part because they are subject to
rigorous requirements. The clinical trial process is also time-consuming. In addition, we will need
to develop appropriate formulations of our drug candidates for use in clinical trials, such as an
oral formulation of CK-1827452. According to industry studies, the entire drug development and
testing process takes on average 12 to 15 years, and the fully capitalized resource cost of new
drug development averages approximately $800 million. However, individual clinical trials and
individual drug candidates may incur a range of costs or time demands above or below this average.
We estimate that clinical trials of our most advanced drug candidates will continue for several
years, but they may take significantly longer to complete. The commencement and completion of our
clinical trials could be delayed or prevented by many factors, including, but not limited to:
|
|
|
delays in obtaining, or inability to obtain, regulatory or other approvals to commence
and conduct clinical trials in the manner we or our partners deem necessary for the
appropriate and timely development of our drug candidates and commercialization of any
resulting drugs; |
|
|
|
|
delays in identifying and reaching agreement, or inability to identify and reach
agreement, on acceptable terms with prospective clinical trial sites; |
|
|
|
|
delays in developing, or inability to develop, appropriate formulations of our drug
candidates for clinical trial use; |
|
|
|
|
for those drug candidates that are the subject of a strategic alliance, delays in
reaching agreement with our partner as to appropriate development strategies; |
|
|
|
|
slower than expected rates of patient recruitment and enrollment, including as a result
of the introduction of alternative therapies or drugs by others; |
|
|
|
|
lack of effectiveness during clinical trials; |
|
|
|
|
unforeseen safety issues; |
|
|
|
|
inadequate supply of clinical trial materials; |
|
|
|
|
uncertain dosing issues; |
|
|
|
|
introduction of new therapies or changes in standards of practice or regulatory guidance
that render our clinical trial endpoints or the targeting of our proposed indications
obsolete; |
|
|
|
|
inability to monitor patients adequately during or after treatment; and |
|
|
|
|
inability or unwillingness of medical investigators to follow our clinical protocols. |
We do not know whether planned clinical trials will begin on time, or whether planned or
currently ongoing clinical trials will need to be restructured or will be completed on schedule, if
at all. Significant delays in clinical trials will impede our ability to commercialize our drug
candidates and generate revenue and could significantly increase our development costs.
We have limited capacity to carry out our own clinical trials in connection with the development
of our drug candidates and potential drug candidates and, to the extent we elect to develop a
drug candidate without a strategic partner, we will need to expand our development capacity
and will require additional funding.
28
The development of drug candidates is complicated, and the resources that we currently have to
carry out such development are limited. Pursuant to our collaboration and option agreement with
Amgen, we are responsible for conducting Phase II clinical development for our drug candidate
CK-1827452. We cannot engage another strategic partner for CK-1827452 until Amgen elects not to
exercise its option to conduct later-stage clinical development for CK-1827452 or its option
expires. If Amgen elects not to exercise its option to conduct later-stage clinical development for
CK-1827452, we do not have an alternative strategic partner for that program. Pursuant to our
amended collaboration and license agreement with GSK, we are now responsible for conducting
clinical development for our drug candidates ispinesib and SB-743921. Currently, we rely on GSK to
conduct pre-clinical and clinical development for GSK-923295 and the NCI to conduct certain
clinical trials for ispinesib. We cannot engage another strategic partner for ispinesib or
SB-743921 until GSKs option to conduct later-stage clinical development for that drug candidate
expires. If GSK elects to terminate its development efforts with respect to GSK-923295, or not to
exercise its option to conduct later-stage clinical development for either of ispinesib or
SB-743921, we do not have an alternative strategic partner for these programs.
For our drug candidates for which we expect to conduct clinical trials at our expense, such as
CK-1827452, ispinesib and SB-743921, we plan to rely on contractors for the manufacture and
distribution of clinical supplies. To the extent we conduct clinical trials for a drug candidate
without support from a strategic partner, we will need to develop additional skills, technical
expertise and resources necessary to carry out such development efforts on our own or through the
use of other third parties, such as contract research organizations, or CROs, and will incur
significant additional costs.
If we utilize CROs, we will not have control over many aspects of their activities, and will
not be able to fully control the amount or timing of resources that they devote to our programs.
These third parties also may not assign as high a priority to our programs or pursue them as
diligently as we would if we were undertaking such programs ourselves, and therefore may not
complete their respective activities on schedule. CROs may also have relationships with our
competitors and potential competitors, and may prioritize those relationships ahead of their
relationships with us. The failure of CROs to carry out development efforts on our behalf according
to our requirements and the FDAs or other regulatory agencies standards and in accordance with
applicable laws, or our failure to properly coordinate and manage such efforts, could increase the
cost of our operations and delay or prevent the development, approval and commercialization of our
drug candidates. In addition, if a CRO fails to perform as agreed, our ability to collect damages
may be contractually limited.
If we fail to develop the additional skills, technical expertise and resources necessary to
carry out the development of our drug candidates, or if we fail to effectively manage our CROs
carrying out such development, the commercialization of our drug candidates will be delayed or
prevented.
We depend on GSK for the conduct, completion and funding of the clinical development and
commercialization of GSK-923295.
Under our strategic alliance with GSK, as amended, GSK is responsible for the clinical
development and obtaining and maintaining regulatory approval of our potential drug candidate
GSK-923295 for cancer and other indications. GSK is responsible for filing applications with the
FDA or other regulatory authorities for approval of GSK-923295 and will be the owner of any
marketing approvals issued by the FDA or other regulatory authorities for GSK-923295. If the FDA or
other regulatory authorities approve GSK-923295, GSK will also be responsible for the marketing and
sale of the resulting drug. Because GSK is responsible for these functions, we cannot control
whether GSK will devote sufficient attention and resources to the clinical trials program for
GSK-923295 or will proceed in an expeditious manner. GSK generally has discretion to elect whether
to pursue or abandon the development of GSK-923295 and may terminate our strategic alliance for any
reason upon six months prior notice. These decisions are outside our control.
In particular, if the initial clinical results of some of its early clinical trials do not
meet GSKs expectations, GSK may elect to terminate further development of GSK-923295 or certain of
the potential clinical trials for GSK-923295, even if the actual number of patients treated at such
time is relatively small. If GSK abandons GSK-923295, it would result in a delay in or prevent us
from commercializing GSK-923295, and would delay or prevent our ability to generate revenues.
Disputes may arise between us and GSK, which may delay or cause the termination of any GSK-923295
clinical trials, result in significant litigation or arbitration, or cause GSK to act in a manner
that is not in our best interest. If development of GSK-923295 does not progress for these or any
other reasons, we would not receive further milestone payments from GSK with respect to GSK-923295.
Even if the FDA or other regulatory agencies approve GSK-923295, GSK may elect not to proceed with
the commercialization of the resulting drug. These decisions are outside our control. In such
event, or if GSK abandons development of GSK-923295 prior to regulatory approval, we would have to
seek a new partner for clinical development or commercialization or curtail or abandon such
clinical development or commercialization or undertake and fund the clinical development of
GSK-923295 or commercialization of the resulting drug ourselves. If we seek a new partner but are
unable to do so on acceptable terms, or at all, or do not have sufficient funds to conduct
29
such development or commercialization ourselves, we would have to curtail or abandon such
development or commercialization, which could harm our business.
If we fail to enter into and maintain successful strategic alliances for certain of our drug
candidates, we may have to reduce or delay our drug candidate development or increase our
expenditures.
Our strategy for developing, manufacturing and commercializing certain of our drug candidates
currently requires us to enter into and successfully maintain strategic alliances with
pharmaceutical companies or other industry participants to advance our programs and reduce our
expenditures on each program. However, we may not be able to negotiate additional strategic
alliances on acceptable terms, if at all. If we are not able to maintain our existing strategic
alliances or establish and maintain additional strategic alliances, we may have to limit the size
or scope of, or delay, one or more of our drug development programs or research programs or
undertake and fund these programs ourselves. If we elect to increase our expenditures to fund drug
development programs or research programs on our own, as we have under the November 2006 amendment
to our collaboration and license agreement with GSK through which we will be responsible for the
clinical development of ispinesib and SB-743921, we will need to obtain additional capital, which
may not be available on acceptable terms, or at all.
The success of our development efforts depends in part on the performance of our strategic
partners and the NCI, over which we have little or no control.
Our ability to commercialize drugs that we develop with our partners and that generate
royalties from product sales depends on our partners abilities to assist us in establishing the
safety and efficacy of our drug candidates, obtaining and maintaining regulatory approvals and
achieving market acceptance of the drugs once commercialized. Our partners may elect to delay or
terminate development of one or more drug candidates, independently develop drugs that could
compete with ours or fail to commit sufficient resources to the marketing and distribution of drugs
developed through their strategic alliances with us. Our partners may not proceed with the
development and commercialization of our drug candidates with the same degree of urgency as we
would because of other priorities they face. In particular, we are relying on the NCI, a government
agency, to conduct several clinical trials of ispinesib and GSK to conduct clinical development of
GSK-923295. There can be no assurance that GSK or the NCI, or both, will not modify their
respective plans to conduct such clinical development or will proceed with such clinical
development diligently. In addition, if GSK exercises its option with respect to either or both of
ispinesib and SB-743921, or if Amgen exercises its option with respect to CK-1827452, they will
then be responsible for the clinical development of those respective drug candidates. We have no
control over the conduct of clinical development being conducted or that may be conducted in the
future by GSK, the NCI or Amgen, including the timing of initiation, termination or completion of
such clinical trials, the analysis of data arising out of such clinical trials or the timing of
release of complete data concerning such clinical trials, which may impact our ability to report on
their results. If our partners fail to perform as we expect, our potential for revenue from drugs
developed through our strategic alliances, if any, could be dramatically reduced.
We have no manufacturing capacity and depend on our strategic partners or contract manufacturers
to produce our clinical trial drug supplies for each of our drug candidates and potential drug
candidates, and anticipate continued reliance on contract manufacturers for the development
and commercialization of our potential drugs.
We do not currently operate manufacturing facilities for clinical or commercial production of
our drug candidates or potential drug candidates. We have limited experience in drug formulation
and manufacturing, and we lack the resources and the capabilities to manufacture any of our drug
candidates on a clinical or commercial scale. As a result, we will rely on GSK to be responsible
for such activities for the planned GSK-923295 clinical trial. For CK-1827452, ispinesib, SB-743921
and any future drug candidates for which we conduct clinical development, we expect to rely on a
limited number of contract manufacturers, and, in particular, we expect to rely on single-source
contract manufacturers for the active pharmaceutical ingredient and the drug product supply for our
clinical trials. If any of our existing or future contract manufacturers fail to perform as agreed,
it could delay clinical development or regulatory approval of our drug candidates or
commercialization of our drugs, producing additional losses and depriving us of potential product
revenues. In addition, if a contract manufacturer fails to perform as agreed, our ability to
collect damages may be contractually limited.
Our drug candidates require precise, high quality manufacturing. The failure to achieve and
maintain high manufacturing standards, including the incidence of manufacturing errors, could
result in patient injury or death, product recalls or withdrawals, delays or failures in product
testing or delivery, cost overruns or other problems that could seriously hurt our business.
Contract drug manufacturers often encounter difficulties involving production yields, quality
control and quality assurance, as well as shortages of qualified personnel. These manufacturers are
subject to stringent regulatory requirements, including the FDAs current good
30
manufacturing practices regulations and similar foreign laws. Each contract manufacturer must
pass a pre-approval inspection before we can obtain marketing approval for any of our drug
candidates and following approval will be subject to ongoing periodic unannounced inspections by
the FDA, the U.S. Drug Enforcement Agency and other regulatory agencies, to ensure strict
compliance with current good manufacturing practices and other applicable government regulations
and corresponding foreign standards. However, we do not have control over our contract
manufacturers compliance with these regulations and standards. If one of our contract
manufacturers fails to pass its pre-approval inspection or maintain on-going compliance, the
production of our drug candidates could be interrupted, resulting in delays, additional costs and
potentially lost revenues.
If the FDA or other regulatory agencies approve any of our drug candidates for commercial
sale, we will need to manufacture them in larger quantities. To date, our drug candidates have been
manufactured only in small quantities for preclinical testing and clinical trials. We may not be
able to successfully increase the manufacturing capacity, whether in collaboration with contract
manufacturers or on our own, for any of our drug candidates in a timely or economical manner, or at
all. Significant scale-up of manufacturing may require additional validation studies, which the FDA
must review and approve. If we are unable to successfully increase the manufacturing capacity for a
drug candidate, the regulatory approval or commercial launch of any related drugs may be delayed or
there may be a shortage in supply. Even if any contract manufacturer makes improvements in the
manufacturing process for our drug candidates, we may not own, or may have to share, the
intellectual property rights to such improvements.
In addition, our existing and future contract manufacturers may not perform as agreed or may
not remain in the contract manufacturing business for the time required to successfully produce,
store and distribute our drug candidates. If a natural disaster, business failure, strike or other
difficulty occurs, we may be unable to replace such contract manufacturer in a timely manner and
the production of our drug candidates would be interrupted, resulting in delays and additional
costs.
Switching manufacturers or manufacturing sites may be difficult and time consuming because the
number of potential manufacturers is limited. In addition, before a drug from any replacement
manufacturer or manufacturing site can be commercialized, the FDA must approve that site. Such
approval would require new testing and compliance inspections. A new manufacturer or manufacturing
site also would have to be educated in, or develop substantially equivalent processes for,
production of our drugs after receipt of FDA approval. It may be difficult or impossible for us to
find a replacement manufacturer on acceptable terms quickly, or at all, which would delay or
prevent our ability to commercialize our drugs.
We may not be able to successfully scale-up manufacture of our drug candidates in sufficient
quality and quantity, which would delay or prevent us from developing our drug candidates and
commercializing resulting approved drugs, if any.
To date, our drug candidates have been manufactured in small quantities for preclinical
studies and early-stage clinical trials. In order to conduct larger scale or late-stage clinical
trials for a drug candidate and for commercialization of the resulting drug if that drug candidate
is approved for sale, we will need to manufacture it in larger quantities. We may not be able to
successfully increase the manufacturing capacity for any of our drug candidates, whether in
collaboration with third-party manufacturers or on our own, in a timely or cost-effective manner or
at all. Significant scale-up of manufacturing may require additional validation studies, which are
costly and which the FDA must review and approve. In addition, quality issues may arise during such
scale-up activities because of the inherent properties of a drug candidate itself or of a drug
candidate in combination with other components added during the manufacturing and packaging
process. If we are unable to successfully scale-up manufacture of any of our drug candidates in
sufficient quality and quantity, the development, regulatory approval or commercial launch of that
drug candidate may be delayed or there may be a shortage in supply, which could significantly harm
our business.
We currently have no marketing or sales staff, and if we are unable to enter into or maintain
strategic alliances with marketing partners or if we are unable to develop our own sales and
marketing capabilities, we may not be successful in commercializing our potential drugs.
We currently have no sales, marketing or distribution capabilities. To commercialize our drugs
that we determine not to market on our own, we will depend on strategic alliances with third
parties, such as GSK and Amgen, which have established distribution systems and direct sales
forces. If we are unable to enter into such arrangements on acceptable terms, we may not be able to
successfully commercialize such drugs.
We plan to commercialize drugs on our own, with or without a partner, that can be effectively
marketed and sold in concentrated markets that do not require a large sales force to be
competitive. To achieve this goal, we will need to establish our own specialized sales force and
marketing organization with technical expertise and with supporting distribution capabilities.
Developing such an
31
organization is expensive and time-consuming and could delay a product launch. In addition, we
may not be able to develop this capacity efficiently, cost-effectively or at all, which could make
us unable to commercialize our drugs.
To the extent that we are not successful in commercializing any drugs ourselves or through a
strategic alliance, our product revenues will suffer, our business and reputation will suffer and
the price of our common stock could decrease.
Our focus on the discovery of drug candidates directed against specific proteins and pathways
within the cytoskeleton is unproven, and we do not know whether we will be able to develop any
drug candidates of commercial value.
We believe that our focus on drug discovery and development directed at the cytoskeleton is
novel and unique. While a number of commonly used drugs and a growing body of research validate the
importance of the cytoskeleton in the origin and progression of a number of diseases, no existing
drugs specifically and directly interact with the cytoskeletal proteins and pathways that our drug
candidates seek to modulate. As a result, we cannot be certain that our drug candidates will
appropriately modulate the targeted cytoskeletal proteins and pathways or produce commercially
viable drugs that safely and effectively treat heart failure, cancer or other diseases, or that the
results we have seen in preclinical models will translate into similar results in humans. In
addition, even if we are successful in developing and receiving regulatory approval for a
commercially viable drug for the treatment of one disease focused on the cytoskeleton, we cannot be
certain that we will also be able to develop and receive regulatory approval for drug candidates
for the treatment of other forms of that disease or other diseases. If we or our partners fail to
develop and commercialize viable drugs, we will not achieve commercial success.
Our proprietary rights may not adequately protect our technologies and drug candidates.
Our commercial success will depend in part on our obtaining and maintaining patent and trade
secret protection of our technologies and drug candidates as well as successfully defending these
patents against third-party challenges. We will only be able to protect our technologies and drug
candidates from unauthorized use by third parties to the extent that valid and enforceable patents
or trade secrets cover them. In the event that our issued patents and our patent applications, if
granted, do not adequately describe, enable or otherwise provide coverage of our technologies and
drug candidates, including CK-1827452, ispinesib, SB-743921 and GSK-923295, we would not be able to
exclude others from developing or commercializing these drug candidates and potential drug
candidates. Furthermore, the degree of future protection of our proprietary rights is uncertain
because legal means may not adequately protect our rights or permit us to gain or keep our
competitive advantage.
The patent positions of life sciences companies can be highly uncertain and involve complex
legal and factual questions for which important legal principles remain unresolved. No consistent
policy regarding the breadth of claims allowed in such companies patents has emerged to date in
the United States. The patent situation outside the United States is even more uncertain. Changes
in either the patent laws or in interpretations of patent laws in the United States or other
countries may diminish the value of our intellectual property. Accordingly, we cannot predict the
breadth of claims that may be allowed or enforced in our patents or in third-party patents. For
example:
|
|
|
we or our licensors might not have been the first to make the inventions covered by each
of our pending patent applications and issued patents; |
|
|
|
|
we or our licensors might not have been the first to file patent applications for these
inventions; |
|
|
|
|
others may independently develop similar or alternative technologies or duplicate any of
our technologies without infringing our intellectual property rights; |
|
|
|
|
some or all of our or our licensors pending patent applications may not result in issued
patents; |
|
|
|
|
our and our licensors issued patents may not provide a basis for commercially viable
drugs or therapies, or may not provide us with any competitive advantages, or may be
challenged and invalidated by third parties; |
|
|
|
|
our or our licensors patent applications or patents may be subject to interference,
opposition or similar administrative proceedings; |
|
|
|
|
we may not develop additional proprietary technologies or drug candidates that are patentable; or |
32
|
|
|
the patents of others may prevent us or our partners from discovering, developing or commercializing our drug candidates. |
We also rely on trade secrets to protect our technology, especially where we believe patent
protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While
we use reasonable efforts to protect our trade secrets, our or our partners employees,
consultants, contractors or scientific and other advisors may unintentionally or willfully disclose
our information to competitors. In addition, confidentiality agreements, if any, executed by such
persons may not be enforceable or provide meaningful protection for our trade secrets or other
proprietary information in the event of unauthorized use or disclosure. If we were to enforce a
claim that a third party had illegally obtained and was using our trade secrets, our enforcement
efforts would be expensive and time consuming, and the outcome would be unpredictable. In addition,
courts outside the United States are sometimes less willing to protect trade secrets. Moreover, if
our competitors independently develop information that is equivalent to our trade secrets, it will
be more difficult for us to enforce our rights and our business could be harmed.
If we are not able to defend the patent or trade secret protection position of our
technologies and drug candidates, then we will not be able to exclude competitors from developing
or marketing competing drugs, and we may not generate enough revenue from product sales to justify
the cost of development of our drugs and to achieve or maintain profitability.
If we are sued for infringing intellectual property rights of third parties, such litigation
will be costly and time consuming, and an unfavorable outcome would have a significant adverse
effect on our business.
Our ability to commercialize drugs depends on our ability to sell such drugs without
infringing the patents or other proprietary rights of third parties. Numerous U.S. and foreign
issued patents and pending patent applications owned by third parties exist in the areas that we
are exploring. In addition, because patent applications can take several years to issue, there may
be currently pending applications, unknown to us, which may later result in issued patents that our
drug candidates may infringe. There could also be existing patents of which we are not aware that
our drug candidates may inadvertently infringe.
In particular, we are aware of an issued U.S. patent and at least one pending U.S. patent
application assigned to Curis, Inc., or Curis, relating to certain compounds in the quinazolinone
class. Ispinesib falls into this class of compounds. The Curis patent claims a method of use for
inhibiting signaling by what is called the hedgehog pathway using certain such compounds. Curis has
pending applications in Europe, Japan, Australia and Canada with claims covering certain
quinazolinone compounds, compositions thereof and/or methods of their use. We are also aware that
two of the Australian applications have been allowed and two of the European applications have been
granted. In Europe, Australia and elsewhere, the grant of a patent may be opposed by one or more
parties. We have opposed the granting of certain such patents to Curis in Europe and in Australia.
A third party has also opposed the grant of one of Curis European patents. Curis or a third party
may assert that the sale of ispinesib may infringe one or more of these or other patents. We
believe that we have valid defenses against the Curis patents if asserted against us. However, we
cannot guarantee that a court would find such defenses valid or that such oppositions would be
successful. We have not attempted to obtain a license to this patent. If we decide to obtain a
license to these patents, we cannot guarantee that we would be able to obtain such a license on
commercially reasonable terms, or at all.
Other future products of ours may be impacted by patents of companies engaged in competitive
programs with significantly greater resources (such as Bayer AG, Merck & Co., Inc., or Merck, Merck
GMBH, Eli Lilly and Company, or Lilly, Bristol-Myers Squibb, or BMS, Array Biopharma Inc., or
Array, ArQule, Inc., or ArQule, and AstraZeneca). Further development of these products could be
impacted by these patents and result in significant legal fees.
If a third party claims that our actions infringe on their patents or other proprietary
rights, we could face a number of issues that could seriously harm our competitive position,
including, but not limited to:
|
|
|
infringement and other intellectual property claims that, with or without merit, can be
costly and time-consuming to litigate and can delay the regulatory approval process and
divert managements attention from our core business strategy; |
|
|
|
|
substantial damages for past infringement which we may have to pay if a court determines
that our drugs or technologies infringe a competitors patent or other proprietary rights; |
|
|
|
|
a court prohibiting us from selling or licensing our drugs or technologies unless the
holder licenses the patent or other proprietary rights to us, which it is not required to
do; and |
33
|
|
|
if a license is available from a holder, we may have to pay substantial royalties or
grant cross licenses to our patents or other proprietary rights. |
If any of these events occur, it could significantly harm our business and negatively affect
our stock price.
We may become involved in disputes with our strategic partners over intellectual property
ownership, and publications by our research collaborators and scientific advisors could impair
our ability to obtain patent protection or protect our proprietary information, which, in
either case, would have a significant impact on our business.
Inventions discovered under our strategic alliance agreements become jointly owned by our
strategic partners and us in some cases, and the exclusive property of one of us in other cases.
Under some circumstances, it may be difficult to determine who owns a particular invention, or
whether it is jointly owned, and disputes could arise regarding ownership of those inventions.
These disputes could be costly and time consuming, and an unfavorable outcome would have a
significant adverse effect on our business if we were not able to protect or license rights to
these inventions. In addition, our research collaborators and scientific advisors have contractual
rights to publish data and other proprietary information, subject to our prior review. Publications
by our research collaborators and scientific advisors containing such information, either with our
permission or in contravention of the terms of their agreements with us, could benefit our current
or potential competitors and may impair our ability to obtain patent protection or protect our
proprietary information, which could significantly harm our business.
To the extent we elect to fund the development of a drug candidate or the commercialization of a
drug at our expense, we will need substantial additional funding.
The discovery, development and commercialization of new drugs for the treatment of a wide
array of diseases is costly. As a result, to the extent we elect to fund the development of a drug
candidate or the commercialization of a drug at our expense, we will need to raise additional
capital to:
|
|
|
expand our research and development and technologies; |
|
|
|
|
fund clinical trials and seek regulatory approvals; |
|
|
|
|
build or access manufacturing and commercialization capabilities; |
|
|
|
|
implement additional internal systems and infrastructure; |
|
|
|
|
maintain, defend and expand the scope of our intellectual property; and |
|
|
|
|
hire and support additional management and scientific personnel. |
Our future funding requirements will depend on many factors, including, but not limited to:
|
|
|
the rate of progress and cost of our clinical trials and other research and development activities; |
|
|
|
|
the costs and timing of seeking and obtaining regulatory approvals; |
|
|
|
|
the costs associated with establishing manufacturing and commercialization capabilities; |
|
|
|
|
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; |
|
|
|
|
the costs of acquiring or investing in businesses, products and technologies; |
|
|
|
|
the effect of competing technological and market developments; and |
|
|
|
|
the payment and other terms and timing of any strategic alliance, licensing or other arrangements that we may establish. |
Until we can generate a sufficient amount of product revenue to finance our cash requirements,
which we may never do, we expect to continue to finance our future cash needs primarily through
public or private equity offerings, debt financings and strategic
34
alliances. We cannot be certain that additional funding will be available on acceptable terms,
or at all. If we are not able to secure additional funding when needed, we may have to delay,
reduce the scope of or eliminate one or more of our clinical trials or research and development
programs or future commercialization initiatives.
We expect to expand our development, clinical research, sales and marketing capabilities, and as
a result, we may encounter difficulties in managing our growth, which could disrupt our
operations.
We expect to have significant growth in expenditures, the number of our employees and the
scope of our operations, in particular with respect to those drug candidates that we elect to
develop or commercialize independently or together with a partner. To manage our anticipated future
growth, we must continue to implement and improve our managerial, operational and financial
systems, expand our facilities and continue to recruit and train additional qualified personnel.
Due to our limited resources, we may not be able to effectively manage the expansion of our
operations or recruit and train additional qualified personnel. The physical expansion of our
operations may lead to significant costs and may divert our management and business development
resources. Any inability to manage growth could delay the execution of our business plans or
disrupt our operations.
The failure to attract and retain skilled personnel could impair our drug development and
commercialization efforts.
Our performance is substantially dependent on the performance of our senior management and key
scientific and technical personnel, particularly James H. Sabry, M.D., Ph.D., our Executive
Chairman, Robert I. Blum, our President and Chief Executive Officer, Andrew A. Wolff, M.D.,
F.A.C.C., our Senior Vice President, Clinical Research and Development and Chief Medical Officer,
Sharon A. Surrey-Barbari, our Senior Vice President, Finance and Chief Financial Officer, David J.
Morgans, Ph.D., our Senior Vice President of Preclinical Research and Development, Jay K. Trautman,
Ph.D., our Vice President of Discovery Research and Technologies, and David W. Cragg, our Vice
President of Human Resources. The employment of these individuals and our other personnel is
terminable at will with short or no notice. We carry key person life insurance on James H. Sabry.
The loss of the services of any member of our senior management, scientific or technical staff may
significantly delay or prevent the achievement of drug development and other business objectives by
diverting managements attention to transition matters and identification of suitable replacements,
and could have a material adverse effect on our business, operating results and financial
condition. We also rely on consultants and advisors to assist us in formulating our research and
development strategy. All of our consultants and advisors are either self-employed or employed by
other organizations, and they may have conflicts of interest or other commitments, such as
consulting or advisory contracts with other organizations, that may affect their ability to
contribute to us.
In addition, we believe that we will need to recruit additional executive management and
scientific and technical personnel. There is currently intense competition for skilled executives
and employees with relevant scientific and technical expertise, and this competition is likely to
continue. Our inability to attract and retain sufficient scientific, technical and managerial
personnel could limit or delay our product development efforts, which would adversely affect the
development of our drug candidates and commercialization of our potential drugs and growth of our
business.
Risks Related To Our Industry
Our competitors may develop drugs that are less expensive, safer or more effective, which may
diminish or eliminate the commercial success of any drugs that we may commercialize.
We compete with companies that are also developing drug candidates that focus on the
cytoskeleton, as well as companies that have developed drugs or are developing alternative drug
candidates for cardiovascular diseases, cancer and other diseases for which our compounds may be
useful treatments. For example, if CK-1827452 or any other of our compounds is approved for
marketing by the FDA for heart failure, that compound could compete against current generically
available therapies, such as milrinone, dobutamine or digoxin or newer drugs such as nesiritide.
In addition, other pharmaceutical and biopharmaceutical companies are developing other approaches
to the treatment of heart failure.
Similarly, if approved for marketing by the FDA, depending on the approved clinical
indication, our cancer drug candidates such as ispinesib and SB-743921 could compete against
existing cancer treatments such as paclitaxel, docetaxel, vincristine, vinorelbine or navelbine and
potentially against other novel cancer drug candidates that are currently in development such as
those that are reformulated taxanes, other tubulin binding compounds or epothilones. We are also
aware that Merck, Lilly, Array, BMS, ArQule and others are conducting research and development
focused on KSP and other mitotic kinesins. In addition, other pharmaceutical and biopharmaceutical
companies are developing other approaches to inhibiting mitosis.
35
Our competitors may:
|
|
|
develop drug candidates and market drugs that are less expensive or more effective than our future drugs; |
|
|
|
|
commercialize competing drugs before we or our partners can launch any drugs developed from our drug candidates; |
|
|
|
|
hold or obtain proprietary rights that could prevent us from commercializing our products; |
|
|
|
|
initiate or withstand substantial price competition more successfully than we can; |
|
|
|
|
more successfully recruit skilled scientific workers from the limited pool of available talent; |
|
|
|
|
more effectively negotiate third-party licenses and strategic alliances; |
|
|
|
|
take advantage of acquisition or other opportunities more readily than we can; |
|
|
|
|
develop drug candidates and market drugs that increase the levels of safety or efficacy
that our drug candidates will need to show in order to obtain regulatory approval; or |
|
|
|
|
introduce therapies or market drugs that render the market opportunity for our potential
drugs obsolete. |
We will compete for market share against large pharmaceutical and biotechnology companies and
smaller companies that are collaborating with larger pharmaceutical companies, new companies,
academic institutions, government agencies and other public and private research organizations.
Many of these competitors, either alone or together with their partners, may develop new drug
candidates that will compete with ours. These competitors may, and in certain cases do, operate
larger research and development programs or have substantially greater financial resources than we
do. Our competitors may also have significantly greater experience in:
|
|
|
developing drug candidates; |
|
|
|
|
undertaking preclinical testing and clinical trials; |
|
|
|
|
building relationships with key customers and opinion-leading physicians; |
|
|
|
|
obtaining and maintaining FDA and other regulatory approvals of drug candidates; |
|
|
|
|
formulating and manufacturing drugs; and |
|
|
|
|
launching, marketing and selling drugs. |
If our competitors market drugs that are less expensive, safer or more efficacious than our
potential drugs, or that reach the market sooner than our potential drugs, we may not achieve
commercial success. In addition, the life sciences industry is characterized by rapid technological
change. Because our research approach integrates many technologies, it may be difficult for us to
stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of
technological change we may be unable to compete effectively. Our competitors may render our
technologies obsolete by advances in existing technological approaches or the development of new or
different approaches, potentially eliminating the advantages in our drug discovery process that we
believe we derive from our research approach and proprietary technologies.
The regulatory approval process is expensive, time consuming and uncertain and may prevent our
partners or us from obtaining approvals to commercialize some or all of our drug candidates.
The research, testing, manufacturing, selling and marketing of drug candidates are subject to
extensive regulation by the FDA and other regulatory authorities in the United States and other
countries, which regulations differ from country to country. Neither we nor our partners are
permitted to market our potential drugs in the United States until we receive approval of a new
drug application, or NDA, from the FDA. Neither we nor our partners have received marketing
approval for any of Cytokinetics drug candidates.
36
Obtaining NDA approval can be a lengthy, expensive and uncertain process. In addition, failure
to comply with the FDA and other applicable foreign and U.S. regulatory requirements may subject us
to administrative or judicially imposed sanctions. These include warning letters, civil and
criminal penalties, injunctions, product seizure or detention, product recalls, total or partial
suspension of production, and refusal to approve pending NDAs or supplements to approved NDAs.
Regulatory approval of an NDA or NDA supplement is never guaranteed, and the approval process
typically takes several years and is extremely expensive. The FDA also has substantial discretion
in the drug approval process. Despite the time and expense exerted, failure can occur at any stage,
and we could encounter problems that cause us to abandon clinical trials or to repeat or perform
additional preclinical testing and clinical trials. The number and focus of preclinical studies and
clinical trials that will be required for FDA approval varies depending on the drug candidate, the
disease or condition that the drug candidate is designed to address, and the regulations applicable
to any particular drug candidate. The FDA can delay, limit or deny approval of a drug candidate for
many reasons, including, but not limited to:
|
|
|
a drug candidate may not be safe or effective; |
|
|
|
|
the FDA may not find the data from preclinical testing and clinical trials sufficient; |
|
|
|
|
the FDA might not approve our or our contract manufacturers processes or facilities; or |
|
|
|
|
the FDA may change its approval policies or adopt new regulations. |
If we or our partners fail to receive and maintain regulatory approval for the sale of any
drugs resulting from our drug candidates, it would significantly harm our business and negatively
affect our stock price.
If we or our partners receive regulatory approval for our drug candidates, we will also be
subject to ongoing FDA obligations and continued regulatory review, such as continued safety
reporting requirements, and we may also be subject to additional FDA post-marketing
obligations, all of which may result in significant expense and limit our ability to
commercialize our potential drugs.
Any regulatory approvals that we or our partners receive for our drug candidates may be
subject to limitations on the indicated uses for which the drug may be marketed or contain
requirements for potentially costly post-marketing follow-up studies. In addition, if the FDA
approves any of our drug candidates, the labeling, packaging, adverse event reporting, storage,
advertising, promotion and record-keeping for the drug will be subject to extensive regulatory
requirements. The subsequent discovery of previously unknown problems with the drug, including
adverse events of unanticipated severity or frequency, or the discovery that adverse effects or
toxicities previously observed in preclinical research or clinical trials that were believed to be
minor actually constitute much more serious problems, may result in restrictions on the marketing
of the drug, and could include withdrawal of the drug from the market.
The FDAs policies may change and additional government regulations may be enacted that could
prevent or delay regulatory approval of our drug candidates. We cannot predict the likelihood,
nature or extent of adverse government regulation that may arise from future legislation or
administrative action, either in the United States or abroad. If we are not able to maintain
regulatory compliance, we might not be permitted to market our drugs and our business would suffer.
If physicians and patients do not accept our drugs, we may be unable to generate significant
revenue, if any.
Even if our drug candidates obtain regulatory approval, resulting drugs, if any, may not gain
market acceptance among physicians, healthcare payors, patients and the medical community. Even if
the clinical safety and efficacy of drugs developed from our drug candidates are established for
purposes of approval, physicians may elect not to recommend these drugs for a variety of reasons
including, but not limited to:
|
|
|
timing of market introduction of competitive drugs; |
|
|
|
|
clinical safety and efficacy of alternative drugs or treatments; |
|
|
|
|
cost-effectiveness; |
|
|
|
|
availability of coverage and reimbursement from health maintenance organizations and other third-party payors; |
37
|
|
|
convenience and ease of administration; |
|
|
|
|
prevalence and severity of adverse side effects; |
|
|
|
|
other potential disadvantages relative to alternative treatment methods; or |
|
|
|
|
insufficient marketing and distribution support. |
If our drugs fail to achieve market acceptance, we may not be able to generate significant
revenue and our business would suffer.
The coverage and reimbursement status of newly approved drugs is uncertain and failure to obtain
adequate coverage and reimbursement could limit our ability to market any drugs we may develop
and decrease our ability to generate revenue.
There is significant uncertainty related to the coverage and reimbursement of newly approved
drugs. The commercial success of our potential drugs in both domestic and international markets is
substantially dependent on whether third-party coverage and reimbursement is available for the
ordering of our potential drugs by the medical profession for use by their patients. Medicare,
Medicaid, health maintenance organizations and other third-party payors are increasingly attempting
to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs,
and, as a result, they may not cover or provide adequate payment for our potential drugs. They may
not view our potential drugs as cost-effective and reimbursement may not be available to consumers
or may not be sufficient to allow our potential drugs to be marketed on a competitive basis. If we
are unable to obtain adequate coverage and reimbursement for our potential drugs, our ability to
generate revenue may be adversely affected. Likewise, legislative or regulatory efforts to control
or reduce healthcare costs or reform government healthcare programs could result in lower prices or
rejection of coverage and reimbursement for our potential drugs. Changes in coverage and
reimbursement policies or healthcare cost containment initiatives that limit or restrict
reimbursement for our drugs may cause our revenue to decline.
We may be subject to costly product liability claims and may not be able to obtain adequate
insurance.
The use of our drug candidates in clinical trials may result in adverse effects. We currently
maintain product liability insurance. We cannot predict all the possible harms or adverse effects
that may result from our clinical trials. We may not have sufficient resources to pay for any
liabilities resulting from a claim excluded from, or beyond the limit of, our insurance coverage.
In addition, once we have commercially launched drugs based on our drug candidates, we will
face even greater exposure to product liability claims. This risk exists even with respect to those
drugs that are approved for commercial sale by the FDA and manufactured in facilities licensed and
regulated by the FDA. We intend to secure limited product liability insurance coverage, but may not
be able to obtain such insurance on acceptable terms with adequate coverage, or at reasonable
costs. There is also a risk that third parties that we have agreed to indemnify could incur
liability, or that third parties that have agreed to indemnify us do not fulfill their obligations.
Even if we were ultimately successful in product liability litigation, the litigation would consume
substantial amounts of our financial and managerial resources and may create adverse publicity, all
of which would impair our ability to generate sales of the affected product as well as our other
potential drugs. Moreover, product recalls may be issued at our discretion or at the direction of
the FDA, other governmental agencies or other companies having regulatory control for drug sales.
If product recalls occur, they are generally expensive and often have an adverse effect on the
image of the drugs being recalled as well as the reputation of the drugs developer or
manufacturer.
We may be subject to damages resulting from claims that we or our employees have wrongfully used
or disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at universities or other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims that these employees or we have
inadvertently or otherwise used or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend against these claims. If we fail in
defending such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel. A loss of key research personnel or their work product could hamper
or prevent our ability to commercialize certain potential drugs, which could significantly harm our
business. Even if we are successful in defending against these claims, litigation could result in
substantial costs and distract management.
38
We use hazardous chemicals and radioactive and biological materials in our business. Responding
to any claims relating to improper handling, storage or disposal of these materials could be
time consuming and costly.
Our research and development processes involve the controlled use of hazardous materials,
including chemicals and radioactive and biological materials. Our operations produce hazardous
waste products. We cannot eliminate the risk of accidental contamination or discharge and any
resultant injury from those materials. Federal, state and local laws and regulations govern the
use, manufacture, storage, handling and disposal of hazardous materials. We may be sued for any
injury or contamination that results from our use or the use by third parties of these materials.
Compliance with environmental laws and regulations is expensive, and current or future
environmental regulations may impair our research, development and production efforts.
In addition, our partners may use hazardous materials in connection with our strategic
alliances. To our knowledge, their work is performed in accordance with applicable biosafety
regulations. In the event of a lawsuit or investigation, however, we could be held responsible for
any injury caused to persons or property by exposure to, or release of, these hazardous materials
used by these parties. Further, we may be required to indemnify our partners against all damages
and other liabilities arising out of our development activities or drugs produced in connection
with these strategic alliances, which could be costly and time-consuming and distract management.
Our facilities in California are located near an earthquake fault, and an earthquake or other
types of natural disasters or resource shortages could disrupt our operations and adversely
affect our results.
Important documents and records, such as hard copies of our laboratory books and records for
our drug candidates and compounds, are located in our corporate headquarters at a single location
in South San Francisco, California near active earthquake zones. In the event of a natural
disaster, such as an earthquake or flood, or localized extended outages of critical utilities or
transportation systems, we do not have a formal business continuity or disaster recovery plan, and
could therefore experience a significant business interruption. In addition, California from time
to time has experienced shortages of water, electric power and natural gas. Future shortages and
conservation measures could disrupt our operations and cause expense, thus adversely affecting our
business and financial results.
Risks Related To Our Common Stock
We expect that our stock price will fluctuate significantly, and you may not be able to resell
your shares at or above your investment price.
The stock market, particularly in recent years, has experienced significant volatility,
particularly with respect to pharmaceutical, biotechnology and other life sciences company stocks.
The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does
not relate to the operating performance of the companies represented by the stock. Factors that
could cause volatility in the market price of our common stock include, but are not limited to:
|
|
|
results from, delays in, or discontinuation of, any of the clinical trials for our drug
candidates for the treatment of heart failure or cancer, including the current and proposed
clinical trials for CK-1827452 for heart failure and for ispinesib, SB-743921 and GSK-923295
for cancer, and including delays resulting from slower than expected or suspended patient
enrollment or discontinuations resulting from a failure to meet pre-defined clinical
end-points; |
|
|
|
|
announcements concerning our strategic alliances with Amgen, GSK or future strategic alliances; |
|
|
|
|
announcements concerning clinical trials; |
|
|
|
|
failure or delays in entering additional drug candidates into clinical trials; |
|
|
|
|
failure or discontinuation of any of our research programs; |
|
|
|
|
issuance of new or changed securities analysts reports or recommendations; |
|
|
|
|
developments in establishing new strategic alliances; |
|
|
|
|
market conditions in the pharmaceutical, biotechnology and other healthcare related sectors; |
39
|
|
|
actual or anticipated fluctuations in our quarterly financial and operating results; |
|
|
|
|
developments or disputes concerning our intellectual property or other proprietary rights; |
|
|
|
|
introduction of technological innovations or new commercial products by us or our competitors; |
|
|
|
|
issues in manufacturing our drug candidates or drugs; |
|
|
|
|
market acceptance of our drugs; |
|
|
|
|
third-party healthcare coverage and reimbursement policies; |
|
|
|
|
FDA or other U.S. or foreign regulatory actions affecting us or our industry; |
|
|
|
|
litigation or public concern about the safety of our drug candidates or drugs; |
|
|
|
|
additions or departures of key personnel; or |
|
|
|
|
volatility in the stock prices of other companies in our industry. |
These and other external factors may cause the market price and demand for our common stock to
fluctuate substantially, which may limit or prevent investors from readily selling their shares of
common stock and may otherwise negatively affect the liquidity of our common stock. In addition,
when the market price of a stock has been volatile, holders of that stock have instituted
securities class action litigation against the company that issued the stock. If any of our
stockholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit.
Such a lawsuit could also divert our managements time and attention.
If the ownership of our common stock continues to be highly concentrated, it may prevent you and
other stockholders from influencing significant corporate decisions and may result in
conflicts of interest that could cause our stock price to decline.
As of April 30, 2007, our executive officers, directors and their affiliates beneficially
owned or controlled approximately 26% of the outstanding shares of our common stock (after giving
effect to the exercise of all outstanding vested and unvested options and warrants). Accordingly,
these executive officers, directors and their affiliates, acting as a group, will have substantial
influence over the outcome of corporate actions requiring stockholder approval, including the
election of directors, any merger, consolidation or sale of all or substantially all of our assets
or any other significant corporate transactions. These stockholders may also delay or prevent a
change of control of us, even if such a change of control would benefit our other stockholders. The
significant concentration of stock ownership may adversely affect the trading price of our common
stock due to investors perception that conflicts of interest may exist or arise.
Evolving regulation of corporate governance and public disclosure may result in additional expenses
and continuing uncertainty.
Changing laws, regulations and standards relating to corporate governance and public
disclosure, including the Sarbanes-Oxley Act of 2002, or Sarbanes-Oxley, new Securities and
Exchange Commission, or SEC, regulations and NASDAQ Global Market, or NASDAQ, rules are creating
uncertainty for public companies. We are presently evaluating and monitoring developments with
respect to new and proposed rules and cannot predict or estimate the amount of the additional costs
we may incur or the timing of such costs. For example, compliance with the internal control
requirements of Sarbanes-Oxley section 404 has to date required the commitment of significant
resources to document and test the adequacy of our internal control over financial reporting. While
our assessment, testing and evaluation of the design and operating effectiveness of our internal
control over financial reporting resulted in our conclusion that, as of December 31, 2006, our
internal control over financial reporting was effective, we can provide no assurance as to
conclusions of management or by our independent registered public accounting firm with respect to
the effectiveness of our internal control over financial reporting in the future. These new or
changed laws, regulations and standards are subject to varying interpretations, in many cases due
to their lack of specificity, and, as a result, their application in practice may evolve over time
as new guidance is provided by regulatory and governing bodies. This could result in continuing
uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to
disclosure and governance practices. We are committed to maintaining high standards of corporate
governance and public disclosure. As a result, we intend to invest the resources necessary to
comply with evolving laws, regulations and standards, and this investment may result in increased
general and administrative expenses and a
40
diversion of management time and attention from revenue-generating activities to compliance
activities. If our efforts to comply with new or changed laws, regulations and standards differ
from the activities intended by regulatory or governing bodies, due to ambiguities related to
practice or otherwise, regulatory authorities may initiate legal proceedings against us, which
could be costly and time-consuming, and our reputation and business may be harmed.
Volatility in the stock prices of other companies may contribute to volatility in our stock price.
The stock market in general, and NASDAQ and the market for technology companies in particular,
have experienced significant price and volume fluctuations that have often been unrelated or
disproportionate to the operating performance of those companies. Further, there has been
particular volatility in the market prices of securities of early stage and development stage life
sciences companies. These broad market and industry factors may seriously harm the market price of
our common stock, regardless of our operating performance. In the past, following periods of
volatility in the market price of a companys securities, securities class action litigation has
often been instituted. A securities class action suit against us could result in substantial costs,
potential liabilities and the diversion of managements attention and resources, and could harm our
reputation and business.
We have never paid dividends on our capital stock, and we do not anticipate paying any cash
dividends in the foreseeable future.
We have paid no cash dividends on any of our classes of capital stock to date and we currently
intend to retain our future earnings, if any, to fund the development and growth of our businesses.
In addition, the terms of existing or any future debts may preclude us from paying these dividends.
Our common stock is thinly traded and there may not be an active, liquid trading market for our
common stock.
There is no guarantee that an active trading market for our common stock will be maintained on
NASDAQ, or that the volume of trading will be sufficient to allow for timely trades. Investors may
not be able to sell their shares quickly or at the latest market price if trading in our stock is
not active or if trading volume is limited. In addition, if trading volume in our common stock is
limited, trades of relatively small numbers of shares may have a disproportionate effect on the
market price of our common stock.
Risks Related To The Committed Equity Financing Facility With Kingsbridge
Our committed equity financing facility with Kingsbridge may not be available to us if we elect
to make a draw down, may require us to make additional blackout or other payments to
Kingsbridge, and may result in dilution to our stockholders.
In October 2005, we entered into the CEFF with Kingsbridge. The CEFF entitles us to sell and
obligates Kingsbridge to purchase, from time to time over a period of three years, shares of our
common stock for cash consideration up to an aggregate of $75.0 million, subject to certain
conditions and restrictions. Kingsbridge will not be obligated to purchase shares under the CEFF
unless certain conditions are met, which include a minimum price for our common stock; the accuracy
of representations and warranties made to Kingsbridge; compliance with laws; effectiveness of a
registration statement registering for resale the shares of common stock to be issued in connection
with the CEFF and the continued listing of our stock on NASDAQ. In addition, Kingsbridge is
permitted to terminate the CEFF if it determines that a material and adverse event has occurred
affecting our business, operations, properties or financial condition and if such condition
continues for a period of 10 days from the date Kingsbridge provides us notice of such material and
adverse event. If we are unable to access funds through the CEFF, or if the CEFF is terminated by
Kingsbridge, we may be unable to access capital on favorable terms or at all.
We are entitled, in certain circumstances, to deliver a blackout notice to Kingsbridge to
suspend the use of the resale registration statement and prohibit Kingsbridge from selling shares
under the resale registration statement. If we deliver a blackout notice in the 15 trading days
following the settlement of a draw down, or if the resale registration statement is not effective
in circumstances not permitted by the agreement, then we must make a payment to Kingsbridge, or
issue Kingsbridge additional shares in lieu of this payment, calculated on the basis of the number
of shares held by Kingsbridge (exclusive of shares that Kingsbridge may hold pursuant to exercise
of the Kingsbridge warrant) and the change in the market price of our common stock during the
period in which the use of the registration statement is suspended. If the trading price of our
common stock declines during a suspension of the resale registration statement, the blackout or
other payment could be significant.
Should we sell shares to Kingsbridge under the CEFF, or issue shares in lieu of a blackout
payment, it will have a dilutive effective on the holdings of our current stockholders, and may
result in downward pressure on the price of our common stock. If we draw down under the CEFF, we
will issue shares to Kingsbridge at a discount of up to 10 percent from the volume weighted average
price of our
41
common stock. If we draw down amounts under the CEFF when our share price is decreasing, we
will need to issue more shares to raise the same amount than if our stock price was higher.
Issuances in the face of a declining share price will have an even greater dilutive effect than if
our share price were stable or increasing, and may further decrease our share price.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
In March 2007, James H. Sabry, M.D., Ph.D., the Companys Executive Director, established an
amended 10b5-1 stock trading plan that provides for the exercise of options to purchase up to
203,254 shares of our common stock and the sale of up to 240,000 shares of our common stock on
pre-determined dates from June 11, 2007 through June 11, 2008.
42
ITEM 6. EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Exhibit Description |
3.1
|
|
Amended and Restated Certificate of Incorporation. (1) |
|
|
|
3.2
|
|
Amended and Restated Bylaws. (1) |
|
|
|
4.1
|
|
Specimen Common Stock Certificate. |
|
|
|
4.2
|
|
Fourth Amended and Restated Investors Rights Agreement, dated March 21, 2003, by and among the Company
and certain stockholders of the Registrant. (1) |
|
|
|
4.3
|
|
Loan and Security Agreement, dated September 25, 1998, by and between the Company and Comdisco. (1) |
|
|
|
4.4
|
|
Amendment No. One to Loan and Security Agreement, dated February 1, 1999, by and between the Company and
Comdisco. (1) |
|
|
|
4.5
|
|
Warrant for the purchase of shares of Series A preferred stock, dated September 25, 1998, issued by the
Company to Comdisco. (1) |
|
|
|
4.6
|
|
Loan and Security Agreement, dated December 16, 1999, by and between the Company and Comdisco. (1) |
|
|
|
4.7
|
|
Amendment No. 1 to Loan and Security Agreement, dated June 29, 2000, by and between the Company and
Comdisco. (1) |
|
|
|
4.8
|
|
Warrant for the purchase of shares of Series B preferred stock, dated December 16, 1999, issued by the
Company to Comdisco. (1) |
|
|
|
4.9
|
|
Master Security Agreement, dated February 2, 2001, by and between the Company and General Electric
Capital Corporation. (1) |
|
|
|
4.10
|
|
Cross-Collateral and Cross-Default Agreement by and between the Company and Comdisco. (1) |
|
|
|
4.11
|
|
Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the Company to Bristow
Investments, L.P. (1) |
|
|
|
4.12
|
|
Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the Company to the
Laurence and Magdalena Shushan Family Trust. (1) |
|
|
|
4.13
|
|
Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the Company to Slough
Estates USA Inc. (1) |
|
|
|
4.14
|
|
Warrant for the purchase of shares of Series B preferred stock, dated August 30, 1999, issued by the
Company to The Magnum Trust. (1) |
|
|
|
4.15
|
|
Warrant for the purchase of shares of common stock, dated October 28, 2005, issued by the Company and
Kingsbridge Capital Limited. (2) |
|
|
|
4.16
|
|
Registration Rights Agreement, dated October 28, 2005, by and between the Company and Kingsbridge Capital
Limited. (2) |
|
|
|
4.17
|
|
Registration Rights Agreement, dated as of December 29, 2006, by and between the Company and Amgen Inc.(3) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certifications of the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350). |
|
|
|
(1) |
|
Incorporated by reference from our registration statement on Form S-1, registration number
333-112261, declared effective by the Securities and Exchange Commission on April 29, 2004. |
|
(2) |
|
Incorporated by reference from our Current Report on Form 8-K, filed with the Securities and
Exchange Commission on January 20, 2006. |
|
(3) |
|
Incorporated by reference from our Current Report on Form 8-K, filed with the Securities and
Exchange Commission on January 3, 2007. |
43
SIGNATURES
Pursuant to the requirements of the Securities Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
Dated: May 9, 2007 |
CYTOKINETICS, INCORPORATED
(Registrant)
|
|
|
/s/ Robert I. Blum
|
|
|
Robert I. Blum |
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
/s/ Sharon Surrey-Barbari
|
|
|
Sharon Surrey-Barbari |
|
|
Senior Vice President, Finance and Chief Financial Officer
(Principal Financial Officer) |
|
44
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
Number |
|
Exhibit Description |
3.1
|
|
Amended and Restated Certificate of Incorporation. (1) |
|
|
|
3.2
|
|
Amended and Restated Bylaws. (1) |
|
|
|
4.1
|
|
Specimen Common Stock Certificate. |
|
|
|
4.2
|
|
Fourth Amended and Restated Investors Rights Agreement, dated March 21, 2003, by and among the Company
and certain stockholders of the Registrant. (1) |
|
|
|
4.3
|
|
Loan and Security Agreement, dated September 25, 1998, by and between the Company and Comdisco. (1) |
|
|
|
4.4
|
|
Amendment No. One to Loan and Security Agreement, dated February 1, 1999, by and between the Company and
Comdisco. (1) |
|
|
|
4.5
|
|
Warrant for the purchase of shares of Series A preferred stock, dated September 25, 1998, issued by the
Company to Comdisco. (1) |
|
|
|
4.6
|
|
Loan and Security Agreement, dated December 16, 1999, by and between the Company and Comdisco. (1) |
|
|
|
4.7
|
|
Amendment No. 1 to Loan and Security Agreement, dated June 29, 2000, by and between the Company and
Comdisco. (1) |
|
|
|
4.8
|
|
Warrant for the purchase of shares of Series B preferred stock, dated December 16, 1999, issued by the
Company to Comdisco. (1) |
|
|
|
4.9
|
|
Master Security Agreement, dated February 2, 2001, by and between the Company and General Electric
Capital Corporation. (1) |
|
|
|
4.10
|
|
Cross-Collateral and Cross-Default Agreement by and between the Company and Comdisco. (1) |
|
|
|
4.11
|
|
Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the Company to Bristow
Investments, L.P. (1) |
|
|
|
4.12
|
|
Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the Company to the
Laurence and Magdalena Shushan Family Trust. (1) |
|
|
|
4.13
|
|
Warrant for the purchase of shares of common stock, dated July 20, 1999, issued by the Company to Slough
Estates USA Inc. (1) |
|
|
|
4.14
|
|
Warrant for the purchase of shares of Series B preferred stock, dated August 30, 1999, issued by the
Company to The Magnum Trust. (1) |
|
|
|
4.15
|
|
Warrant for the purchase of shares of common stock, dated October 28, 2005, issued by the Company and
Kingsbridge Capital Limited. (2) |
|
|
|
4.16
|
|
Registration Rights Agreement, dated October 28, 2005, by and between the Company and Kingsbridge Capital
Limited. (2) |
|
|
|
4.17
|
|
Registration Rights Agreement, dated as of December 29, 2006, by and between the Company and Amgen Inc.(3) |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
31.2
|
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32.1
|
|
Certifications of the Chief Executive Officer and the Chief Financial Officer pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002 (18 U.S.C. Section 1350). |
|
|
|
(1) |
|
Incorporated by reference from our registration statement on Form S-1, registration number
333-112261, declared effective by the Securities and Exchange Commission on April 29, 2004. |
|
(2) |
|
Incorporated by reference from our Current Report on Form 8-K, filed with the Securities and
Exchange Commission on January 20, 2006. |
|
(3) |
|
Incorporated by reference from our Current Report on Form 8-K, filed with the Securities and
Exchange Commission on January 3, 2007. |
45