e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarter Ended June 30, 2005
Commission File No. 000-21429
ArQule, Inc.
(Exact Name of Registrant as Specified in its Charter)
| |
|
|
|
Delaware
|
|
04-3221586 |
|
(State of Incorporation) |
|
(I.R.S. Employer
Identification Number) |
19 Presidential Way, Woburn, Massachusetts 01801
(Address of Principal Executive Offices)
(781) 994-0300
(Registrants Telephone Number, including Area Code)
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 an accelerated
filer (as defined in Rule 12b-2 of the Exchange
Act). Yes þ No o
Number of shares outstanding of the registrants Common
Stock as of August 3, 2005:
|
|
| Common Stock, par value $.01 |
35,170,177 shares outstanding |
ARQULE, INC.
QUARTER ENDED JUNE 30, 2005
TABLE OF CONTENTS
1
ARQULE, INC.
CONDENSED CONSOLIDATED BALANCE SHEET (UNAUDITED)
| |
|
|
|
|
|
|
|
|
|
|
| |
|
June 30, | |
|
December 31, | |
| |
|
2005 | |
|
2004 | |
| |
|
| |
|
| |
| |
|
(In thousands, | |
| |
|
except share data) | |
|
ASSETS |
|
Current assets:
|
|
|
|
|
|
|
|
|
| |
Cash and cash equivalents
|
|
$ |
5,580 |
|
|
$ |
7,131 |
|
| |
Marketable securities
|
|
|
124,604 |
|
|
|
64,234 |
|
| |
Accounts receivable
|
|
|
3,994 |
|
|
|
319 |
|
| |
Prepaid expenses and other current assets
|
|
|
3,402 |
|
|
|
2,893 |
|
| |
|
|
|
|
|
|
| |
|
Total current assets
|
|
|
137,580 |
|
|
|
74,577 |
|
| |
Property and equipment, net
|
|
|
9,352 |
|
|
|
44,895 |
|
| |
Other assets
|
|
|
1,492 |
|
|
|
746 |
|
| |
|
|
|
|
|
|
| |
|
$ |
148,424 |
|
|
$ |
120,218 |
|
| |
|
|
|
|
|
|
| |
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
Current liabilities:
|
|
|
|
|
|
|
|
|
| |
Accounts payable and accrued expenses
|
|
$ |
6,687 |
|
|
$ |
7,683 |
|
| |
Current portion of long-term debt
|
|
|
74 |
|
|
|
144 |
|
| |
Current portion of deferred revenue
|
|
|
11,567 |
|
|
|
11,968 |
|
| |
Current portion of deferred gain on sale leaseback
|
|
|
558 |
|
|
|
|
|
| |
|
|
|
|
|
|
| |
|
Total current liabilities
|
|
|
18,886 |
|
|
|
19,795 |
|
|
Restructuring accrual, net of current portion
|
|
|
2,378 |
|
|
|
2,728 |
|
|
Long-term debt, net of current portion
|
|
|
|
|
|
|
17 |
|
|
Deferred revenue, net of current portion
|
|
|
13,554 |
|
|
|
15,226 |
|
|
Deferred gain on sale leaseback, net of current portion
|
|
|
4,973 |
|
|
|
|
|
| |
|
|
|
|
|
|
| |
|
Total liabilities
|
|
|
39,791 |
|
|
|
37,766 |
|
| |
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
| |
Common stock, $0.01 par value; 50,000,000 shares
authorized; 35,106,617 and 28,982,774 shares issued and
outstanding at June 30, 2005 and December 31, 2004,
respectively
|
|
|
351 |
|
|
|
290 |
|
| |
Additional paid-in capital
|
|
|
301,881 |
|
|
|
271,805 |
|
| |
Accumulated other comprehensive loss
|
|
|
(471 |
) |
|
|
(386 |
) |
| |
Accumulated deficit
|
|
|
(193,128 |
) |
|
|
(189,257 |
) |
| |
|
|
|
|
|
|
| |
|
Total stockholders equity
|
|
|
108,633 |
|
|
|
82,452 |
|
| |
|
|
|
|
|
|
| |
|
$ |
148,424 |
|
|
$ |
120,218 |
|
| |
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
unaudited financial statements.
2
ARQULE, INC.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three Months Ended | |
|
Six Months Ended | |
| |
|
June 30 | |
|
June 30 | |
| |
|
| |
|
| |
| |
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In thousands, except per share data) | |
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Compound development revenue
|
|
$ |
11,802 |
|
|
$ |
12,110 |
|
|
$ |
24,093 |
|
|
$ |
23,603 |
|
| |
Compound development revenue related party
|
|
|
|
|
|
|
250 |
|
|
|
|
|
|
|
518 |
|
| |
Research and development revenue
|
|
|
1,652 |
|
|
|
1,652 |
|
|
|
3,304 |
|
|
|
1,652 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Total revenue
|
|
|
13,454 |
|
|
|
14,012 |
|
|
|
27,397 |
|
|
|
25,773 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Cost of compound development revenue
|
|
|
7,674 |
|
|
|
7,340 |
|
|
|
15,027 |
|
|
|
15,745 |
|
| |
Cost of compound development revenue related party
|
|
|
|
|
|
|
125 |
|
|
|
|
|
|
|
259 |
|
| |
Research and development
|
|
|
6,217 |
|
|
|
4,712 |
|
|
|
12,070 |
|
|
|
9,679 |
|
| |
Marketing, general and administrative
|
|
|
2,238 |
|
|
|
2,215 |
|
|
|
4,922 |
|
|
|
4,818 |
|
| |
Restructuring charge
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,072 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Total costs and expenses
|
|
|
16,129 |
|
|
|
14,392 |
|
|
|
32,019 |
|
|
|
31,573 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Loss from operations
|
|
|
(2,675 |
) |
|
|
(380 |
) |
|
|
(4,622 |
) |
|
|
(5,800 |
) |
|
Net investment income
|
|
|
498 |
|
|
|
246 |
|
|
|
1,001 |
|
|
|
415 |
|
|
Loss on investment
|
|
|
(250 |
) |
|
|
|
|
|
|
(250 |
) |
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Net loss
|
|
$ |
(2,427 |
) |
|
$ |
(134 |
) |
|
$ |
(3,871 |
) |
|
$ |
(5,385 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$ |
(0.07 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.19 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
basic and diluted
|
|
|
34,953 |
|
|
|
28,808 |
|
|
|
34,003 |
|
|
|
28,769 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
unaudited financial statements.
3
ARQULE, INC.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (UNAUDITED)
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Six Months Ended | |
| |
|
June 30 | |
| |
|
| |
| |
|
2005 | |
|
2004 | |
| |
|
| |
|
| |
| |
|
(In thousands) | |
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
| |
Net loss
|
|
$ |
(3,871 |
) |
|
$ |
(5,385 |
) |
| |
Adjustments to reconcile net loss to net cash provided by (used
in) operating activities:
|
|
|
|
|
|
|
|
|
| |
|
Depreciation and amortization
|
|
|
3,396 |
|
|
|
3,723 |
|
| |
|
Amortization of premium/discount on marketable securities
|
|
|
181 |
|
|
|
224 |
|
| |
|
Non-cash restructuring charge
|
|
|
|
|
|
|
76 |
|
| |
|
Non-cash stock compensation
|
|
|
345 |
|
|
|
49 |
|
| |
|
Loss on investment
|
|
|
250 |
|
|
|
|
|
| |
|
Loss on disposal of fixed assets
|
|
|
228 |
|
|
|
|
|
| |
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
| |
|
|
Accounts receivable
|
|
|
(3,675 |
) |
|
|
(3,391 |
) |
| |
|
|
Prepaid expenses and other current assets
|
|
|
(510 |
) |
|
|
613 |
|
| |
|
|
Other assets
|
|
|
(996 |
) |
|
|
135 |
|
| |
|
|
Accounts payable and accrued expenses
|
|
|
(1,346 |
) |
|
|
(3,792 |
) |
| |
|
|
Deferred revenue
|
|
|
(2,073 |
) |
|
|
11,609 |
|
| |
|
|
|
|
|
|
| |
|
|
|
Net cash provided by (used in) operating activities
|
|
|
(8,071 |
) |
|
|
3,861 |
|
| |
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
| |
Purchases of marketable securities
|
|
|
(98,136 |
) |
|
|
(27,348 |
) |
| |
Proceeds from sale or maturity of marketable securities
|
|
|
37,503 |
|
|
|
16,888 |
|
| |
Additions to property and equipment
|
|
|
(1,791 |
) |
|
|
(635 |
) |
| |
Net proceeds from sale of facility
|
|
|
39,385 |
|
|
|
|
|
| |
|
|
|
|
|
|
| |
|
Net cash used in investing activities
|
|
|
(23,039 |
) |
|
|
(11,095 |
) |
| |
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
| |
Principal repayments of long-term debt
|
|
|
(232 |
) |
|
|
(3,476 |
) |
| |
Proceeds from registered direct stock offering, net
|
|
|
28,349 |
|
|
|
|
|
| |
Proceeds from exercise of common stock options
|
|
|
1,442 |
|
|
|
416 |
|
| |
|
|
|
|
|
|
| |
|
Net cash provided by (used in) financing activities
|
|
|
29,559 |
|
|
|
(3,060 |
) |
| |
|
|
|
|
|
|
| |
Effect of foreign exchange rates on cash and cash equivalents
|
|
|
|
|
|
|
14 |
|
| |
|
|
|
|
|
|
| |
Net decrease in cash and cash equivalents
|
|
|
(1,551 |
) |
|
|
(10,280 |
) |
| |
Cash and cash equivalents, beginning of period
|
|
|
7,131 |
|
|
|
18,839 |
|
| |
|
|
|
|
|
|
| |
Cash and cash equivalents, end of period
|
|
$ |
5,580 |
|
|
$ |
8,559 |
|
| |
|
|
|
|
|
|
The accompanying notes are an integral part of these interim
unaudited financial statements.
4
ARQULE, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
| 1. |
Organization and Nature of Operations |
We are a biotechnology company engaged in the research and
development of small molecule cancer therapeutics based on a
novel biological approach to cancer, our Activated Checkpoint
Therapysm
(ACTsm) platform,
and our expertise in small molecule chemistry and intelligent
drug design. We also provide fee-based services to
pharmaceutical companies and biotechnology companies, using our
chemistry-based technology and expertise to attract
collaborators. We have an experienced and highly qualified
scientific and management team that can apply our chemistry
technology platform to produce compounds that have medicinal
attributes.
We are subject to risks common to companies in the biotechnology
and pharmaceutical industries, including but not limited to,
development by the Company or our competitors of new
technological innovations, dependence on key personnel,
protection of proprietary technology, and compliance with
governmental regulation.
We have prepared the accompanying condensed consolidated
financial statements pursuant to the rules and regulations of
the U.S. Securities and Exchange Commission. Certain
information and footnote disclosures normally included in
financial statements prepared in accordance with generally
accepted accounting principles have been condensed or omitted
pursuant to these rules and regulations. These condensed
consolidated financial statements should be read in conjunction
with our audited financial statements and footnotes related
thereto for the year ended December 31, 2004 included in
our annual report on Form 10-K filed with the Securities
and Exchange Commission on March 16, 2005. The unaudited
condensed consolidated financial statements include, in our
opinion, all adjustments (consisting only of normal recurring
adjustments) necessary to present fairly our financial position
as of June 30, 2005, the results of our operations for the
three and six months ended June 30, 2005 and June 30,
2004, and cash flows for the six months ended June 30, 2005
and June 30, 2004. The results of operations and cash flows
for such interim periods are not necessarily indicative of the
results to be achieved for the full year.
The following is a summary of the available-for-sale marketable
securities we held at June 30, 2005 and December 31,
2004 (in thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
Gross |
|
Gross | |
|
|
| |
|
Amortized | |
|
Unrealized |
|
Unrealized | |
|
Fair | |
| June 30, 2005 |
|
Cost | |
|
Gains |
|
Losses | |
|
Value | |
| |
|
| |
|
|
|
| |
|
| |
|
Corporate bonds
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Due within 1 year
|
|
$ |
5,538 |
|
|
$ |
|
|
|
$ |
(9 |
) |
|
$ |
5,529 |
|
| |
Due within 1 to 5 years
|
|
|
11,361 |
|
|
|
|
|
|
|
(76 |
) |
|
|
11,285 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total corporate bonds
|
|
|
16,899 |
|
|
|
|
|
|
|
(85 |
) |
|
|
16,814 |
|
|
US federal and state agency backed securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Due within 1 to 5 years
|
|
|
108,176 |
|
|
|
|
|
|
|
(386 |
) |
|
|
107,790 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities
|
|
$ |
125,075 |
|
|
$ |
|
|
|
$ |
(471 |
) |
|
$ |
124,604 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
5
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
Gross |
|
Gross | |
|
|
| |
|
Amortized | |
|
Unrealized |
|
Unrealized | |
|
Fair | |
| December 31, 2004 |
|
Cost | |
|
Gains |
|
Losses | |
|
Value | |
| |
|
| |
|
|
|
| |
|
| |
|
Corporate bonds
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Due within 1 to 5 years
|
|
$ |
11,567 |
|
|
$ |
|
|
|
$ |
(64 |
) |
|
$ |
11,503 |
|
|
US federal and state agency backed securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Due within 1 to 5 years
|
|
|
53,053 |
|
|
|
|
|
|
|
(322 |
) |
|
|
52,731 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total marketable securities
|
|
$ |
64,620 |
|
|
$ |
|
|
|
$ |
(386 |
) |
|
$ |
64,234 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities are carried at fair market value at
June 30, 2005 and December 31, 2004, and are
classified as current as the funds are highly liquid and are
available to meet working capital needs and to fund current
operations. The gross unrealized losses on marketable securities
at June 30, 2005 and December 31, 2004 relate to
unfavorable market rate fluctuations which have decreased the
fair value of the investments below the amortized cost. The
Company believes these fluctuations are temporary and therefore
has not realized an impairment loss on these investments at
June 30, 2005.
We classify auction rate certificates as marketable securities
in 2005. Our auction rate certificate investments are typically
issued by state agencies and backed by student loans, with
long-term stated contractual maturities and variable interest
rates which reset every 28 days. Through September 30,
2004, such investments were classified as cash and cash
equivalents. Accordingly, for comparative purposes, we have
revised the classification to report these securities as
marketable securities in prior periods. We have also made
corresponding adjustments to our Condensed Consolidated
Statement of Cash Flows for the six months ended June 30,
2004 to reflect the gross purchases and sales of these
securities as investing activities rather than as a component of
cash and cash equivalents. The Company held auction rate
certificates of $18.3 million at June 30, 2004 which
were previously recorded as cash equivalents. Auction rate
security purchases of $7.0 million and sales of
$2.0 million through June 30, 2004 were previously
reflected as cash and cash equivalents in the Condensed
Consolidated Statement of Cash Flows.
|
|
| 4. |
Investment in Non-Marketable Securities |
In July 2001, we purchased approximately 1.8 million
preferred shares of a privately-owned proteomics company for
$5 million, representing an approximate 8% ownership
interest. Based on events affecting the financial condition of
the company during the second quarter of 2005, we determined
that the value of the investment had declined to the degree of
other than temporary impairment, and as such, we recorded a
non-cash loss on investment of $250,000 to write off the
remaining carrying value of this investment.
Comprehensive loss is comprised of net loss and other
comprehensive income (loss). Other comprehensive income (loss)
includes certain changes in stockholders equity that are
excluded from net loss. Other comprehensive income (loss)
includes unrealized gains and losses on our marketable
securities and interest rate swaps and foreign currency
translation amounts. Total comprehensive loss for the three and
six months ended June 30, 2005 and June 30, 2004 was
as follows (in thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three Months Ended | |
|
Six Months Ended | |
| |
|
June 30 | |
|
June 30 | |
| |
|
| |
|
| |
| |
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
| |
|
| |
|
| |
|
| |
|
| |
|
Net loss
|
|
$ |
(2,427 |
) |
|
$ |
(134 |
) |
|
$ |
(3,871 |
) |
|
$ |
(5,385 |
) |
|
Unrealized gain (loss) on marketable securities and interest
rate swaps
|
|
|
117 |
|
|
|
(445 |
) |
|
|
(85 |
) |
|
|
(403 |
) |
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
71 |
|
|
|
|
|
|
|
15 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$ |
(2,310 |
) |
|
$ |
(508 |
) |
|
$ |
(3,956 |
) |
|
$ |
(5,773 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
6
In the first quarter of 2004, we implemented a restructuring to
shift resources from our chemical technologies business to our
internal cancer therapy research and development, consistent
with our decision at that time to focus on oncology. The
restructuring included the termination of 53 staff and
managerial employees, or approximately 18% of the workforce, in
the following areas: 30 in chemistry production positions, 7 in
chemistry-based research and development positions and 16 in
administrative positions. In connection with these actions we
recorded a restructuring charge of $1.1 million in the
first quarter of 2004 for termination benefits. All termination
benefits were paid in 2004.
In 2002, the Company recorded a restructuring charge associated
with abandoning its facility in Redwood City, California. The
remaining facility-related restructuring accrual is primarily
comprised of the difference between the Companys lease
obligation for this facility, which will be paid out through
2010, and the amount of sublease payments it will receive under
its sublease agreement. Current year activity against the
facility-related restructuring accrual was as follows (in
thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Balance as of | |
|
|
|
Balance as of | |
| |
|
December 31, | |
|
|
|
June 30, | |
| |
|
2004 | |
|
Payments | |
|
2005 | |
| |
|
| |
|
| |
|
| |
|
Facility-related accrual
|
|
$ |
3,421 |
|
|
$ |
(462 |
) |
|
$ |
2,959 |
|
The portions of the restructuring accrual which are expected to
be paid out within one year and longer than one year are
included in the Condensed Consolidated Balance Sheet under
Accounts payable and accrued expenses and
Restructuring accrual, net of current portion,
respectively.
The computations of basic and diluted loss per common share are
based upon the weighted average number of common shares
outstanding and potentially dilutive securities, including stock
options. Options to purchase 4,305,120 and
4,502,515 shares of common stock were not included in the
computations of diluted net loss per share for the three and six
months end June 30, 2005 and June 30, 2004,
respectively, because inclusion of such shares would have an
anti-dilutive effect on net loss per share.
|
|
| 8. |
Stock-Based Compensation |
We apply APB No. 25 and related interpretations in
accounting for option grants under the Companys stock
option plans. Had compensation cost been determined based on the
estimated fair value of options at the grant date consistent
with the provisions of SFAS No. 123, as amended, our
pro forma net loss and pro forma basic and diluted net loss per
share would have been as follows for the three months and six
months ended June 30, 2005 and 2004 (in thousands, except
per share amounts):
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Three Months Ended | |
|
Six Months Ended | |
| |
|
June 30 | |
|
June 30 | |
| |
|
| |
|
| |
| |
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
| |
|
| |
|
| |
|
| |
|
| |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss as reported
|
|
$ |
(2,427 |
) |
|
$ |
(134 |
) |
|
$ |
(3,871 |
) |
|
$ |
(5,385 |
) |
| |
Add: Stock-based employee compensation expense included in
reported net loss
|
|
|
289 |
|
|
|
|
|
|
|
289 |
|
|
|
|
|
| |
Less: Total stock-based employee compensation under the fair
value method of SFAS 123
|
|
|
(1,078 |
) |
|
|
(1,154 |
) |
|
|
(2,907 |
) |
|
|
(4,141 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(3,216 |
) |
|
$ |
(1,288 |
) |
|
$ |
(6,489 |
) |
|
$ |
(9,526 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported
|
|
$ |
(0.07 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.19 |
) |
|
Pro forma
|
|
$ |
(0.09 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.33 |
) |
7
For the purposes of pro forma disclosure, the estimated value of
each employee option grant was calculated on the date of grant
using the Black-Scholes option-pricing model. The model was
calculated using the following weighted-average assumptions: no
dividend yield for all years; volatility of 85% for 2005 and 95%
for 2004; risk-free interest rates of 3.71% in 2005 and 1.5% in
2004; expected lives of 6 to 18 months for options granted
under the Companys Employee Stock Purchase Plan; and
expected lives of five years for 2005 and 2004 for all other
options granted.
In December 2004, the FASB issued Statement of Financial
Accounting Standard No. 123R, Accounting for Stock-Based
Compensation (SFAS No. 123R).
SFAS No. 123R requires companies to expense the fair
value of employee stock options and other forms of stock-based
compensation. SFAS No. 123R requires that the fair
value of such stock-based compensation be recognized as an
expense beginning on the date that a company grants the awards
to an employee and as services are performed. Prior to
SFAS No. 123R, only certain pro forma disclosures of
fair value were required. If we had included the fair value of
employee stock options in our financial statements for the three
and six month periods ended June 30, 2005 and June 30,
2004, our net loss would have been as disclosed above. The
provisions of this Statement, which were amended in April 2005,
are effective for fiscal years beginning after June 15,
2005. Accordingly, we will adopt SFAS No. 123R
commencing with the quarter ending March 31, 2006. The
Company is currently studying various adoption alternatives, but
expects the adoption of SFAS No. 123R will have a
material effect on our financial statements.
On January 28, 2005, we sold 5.79 million shares of
common stock at $5.25 per share for aggregate net proceeds
of approximately $28.3 million after commission and
offering expenses.
Since the inception of our contractual agreement with Pfizer Inc
(Pfizer) in 1999, we have produced collections of
chemical compounds exclusively for Pfizer using our automated
high-speed compound production system. Pfizer also received a
non-exclusive license to use this system in its internal
production program. We expanded this contract in December 2001
to a seven-year agreement. We renegotiated this contract again
in early February 2004. Under the amended terms of the contract,
ArQule will continue to work with Pfizers scientists to
match more closely its compound deliveries to those libraries
which Pfizer believes have the greatest developmental
opportunity. Under this new agreement, ArQule will maintain
compound deliveries at approximately the same level supplied in
2004 instead of increasing compound deliveries as specified in
the previous agreement. As of June 30, 2005, we have
received $251 million from Pfizer since the inception of
this relationship in 1999. If our relationship with Pfizer is
successful, we could receive up to an additional
$119 million over the remaining term of the contract.
On April 2, 2004, we announced an alliance with
Hoffmann-La Roche (Roche) to discover and
develop drug candidates targeting the E2F biological pathway.
The alliance includes a compound, ARQ 501, currently in
phase 1 clinical development. Under the terms of our
contractual agreement, Roche obtained an option to license our
E2F program in the field of cancer therapy. Roche provided
immediate research funding of $15 million and is providing
financial support for ongoing research and development. We are
responsible for advancing drug candidates from early stage
development into phase 2 trials. Roche may opt to license
worldwide rights for the development and commercialization of
products resulting from this collaboration by paying an option
fee. Assuming the successful development and commercialization
of a compound under the program, we could receive up to
$276 million in pre-determined payments, plus royalties
based on net sales. Additionally, we have the option to
co-promote products in the U.S. The cost associated with
satisfying the Roche contract is included in research and
development expense in the Condensed Consolidated Statement of
Operations.
8
|
|
| 12. |
Sale Leaseback Transaction |
On May 2, 2005, we completed a transaction to sell our
Woburn facility and simultaneously lease the facility from the
purchaser. The lease was subsequently amended on June 30,
2005. Under the terms of the transaction, the purchaser obtained
two parcels of land and our headquarters building in exchange
for a cash payment of approximately $40.1 million. We are
leasing our existing facility and the associated land for a
period of ten years at an average annual rental rate of
$3.4 million. We also have options to extend the lease for
up to an additional ten years. In accordance with Statement of
Financial Accounting Standards No. 98, Accounting for
Leases, we are applying sale leaseback accounting to the
transaction and are treating the lease as an operating lease. As
a result, we reduced our net fixed assets by $33.7 million,
representing the net book value of the assets sold on the date
of the lease amendment, and realized a gain on the sale of
$5.5 million, which has been deferred and will be amortized
over the initial ten-year lease term as a reduction in rent
expense.
9
|
|
| Item 2. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
Overview
We are a biotechnology company engaged in the research and
development of small molecule cancer therapeutics based on our
proprietary Activated Checkpoint
Therapysm
(ACTsm) platform.
We also provide fee-based chemistry services to pharmaceutical
and biotechnology companies to produce novel chemical compounds
with drug-like characteristics.
We have incurred a cumulative net loss of $193 million from
inception through June 30, 2005. We have recorded a net
loss for the last six years, and we expect to record a net loss
for 2005. Our expenses prior to September 2003 related to our
chemistry services operations and the cost of acquisitions. In
September 2003, we acquired Cyclis Pharmaceuticals, Inc.
(Cyclis), an early stage oncology company. As a
result of our strategic corporate decision to focus on oncology
drug discovery and development following this acquisition, we
expect research and development costs to increase in 2005 and in
future years as we pursue the clinical and pre-clinical
development of products generated from our multiple cancer
programs. We may retain proprietary rights for certain of these
programs, which could require an increased investment. We expect
to continue to operate our chemistry services on a cash flow
positive basis based on the continuation of our contractual
agreement with Pfizer Inc (Pfizer) and to continue
investing in both partnered and proprietary cancer-related
research and development.
Our revenue is derived from chemistry services performed for
customers, particularly Pfizer, and from research and
development funding provided under our agreement with
Hoffmann-La Roche (Roche). Revenue, expenses
and gross margin fluctuate from quarter-to-quarter based upon a
number of factors, notably: the timing of the recognition of
revenue under our revenue recognition policy; the efforts
expended on our chemistry services contractual deliverables; and
the timing and extent of our cancer-related research and
development activities.
Liquidity and Capital Resources
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/(Decrease) | |
| |
|
June 30, | |
|
December 31, | |
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
Cash, cash equivalents and marketable securities
|
|
$ |
130.2 |
|
|
$ |
71.4 |
|
|
$ |
58.8 |
|
|
|
82% |
|
|
Working capital
|
|
|
118.7 |
|
|
|
54.8 |
|
|
|
63.9 |
|
|
|
117% |
|
| |
| |
|
|
Q2 YTD 2005 |
|
|
|
Q2 YTD 2004 |
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Cash flow from:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Operating activities
|
|
$ |
(8.1 |
) |
|
$ |
3.9 |
|
|
$ |
(11.9 |
) |
|
|
nm |
|
| |
Investing activities
|
|
|
(23.0 |
) |
|
|
(11.1 |
) |
|
|
(11.9 |
) |
|
|
nm |
|
| |
Financing activities
|
|
|
29.6 |
|
|
|
(3.1 |
) |
|
|
32.6 |
|
|
|
nm |
|
nm = not meaningful
Cash flow from operating activities. Cash used in
operating activities has primarily consisted of salaries and
wages, facility and facility-related costs, preclinical and
clinical study costs, laboratory supplies and materials, and
professional fees. The sources of our cash flow from operating
activities have consisted of payments from our collaborators for
services performed or upfront payments for future services.
For the six months ended June 30, 2005, the net use of cash
of $8.1 million was primarily comprised of an increase in
accounts receivable of $3.7 million related to amounts due
from Pfizer, an increase in prepaid and other assets of
$1.5 million, a decrease in accounts payable and accruals
of $1.3 million, and a reduction in deferred revenues of
$2.1 million, partially offset by an operating profit
(excluding non-cash items) of $0.5 million.
10
Cash flow from investing activities. For the six months
ended June 30, 2005, the net use of $23.0 million was
comprised of net purchases of marketable securities of
$60.6 million and acquisitions of fixed assets of
$1.8 million, offset by the proceeds from the sale of the
Companys Woburn headquarters facility, net of commissions
and closing costs, of $39.4 million. The net purchases of
marketable securities reflect the investment of the
Companys net proceeds from the issuance of common stock
and the sale of its Woburn facility. The composition and mix of
cash, cash equivalents and marketable securities may change
frequently as a result of the Companys constant evaluation
of conditions in financial markets, the timing of specific
investments and the Companys near term need for liquidity.
Cash flow from financing activities. For the six months
ended June 30, 2005, the total source of $29.7 million
was comprised of the proceeds from our January 28, 2005
stock offering, whereby we sold 5.79 million shares of
common stock at $5.25 per share for aggregate net proceeds
of $28.3 million after commissions and offering expenses,
and the proceeds from the issuance of common stock associated
with the exercise of stock options of $1.4 million,
partially offset by principal payments on long-term debt of
$0.2 million.
As more fully disclosed in Note 12 to our condensed
consolidated financial statements, on May 2, 2005 we
completed a transaction to sell and lease back our Woburn
facility. The lease portion of the transaction was amended on
June 30, 2005. Pursuant to the terms of the agreement, we
received approximately $40.1 million, before commissions
and closing costs, and will lease our existing facility for a
period of ten years at an average annual rental rate of
$3.4 million. We also have options to extend the lease for
up to an additional ten years.
We do not expect to be cash flow positive from operations in
2005 as we pursue development of our cancer programs. We expect
that our available cash and marketable securities of
$130 million at June 30, 2005, together with operating
revenues and investment income, will be sufficient to finance
our working capital and capital requirements for approximately
the next three years.
Our cash requirements may vary materially from those now
planned, depending upon the results of our drug discovery and
development strategies, our ability to enter into any additional
corporate collaborations in the future and the terms of such
collaborations, results of research and development, the need
for currently unanticipated capital expenditures, competitive
and technological advances, acquisitions and other factors. We
cannot guarantee that we will be able to obtain additional
customers for our chemistry services, or that such services will
produce revenues adequate to fund our operating expenses. We
cannot guarantee that we will be able to develop any of our drug
candidates into a commercial product. If we experience increased
losses, we may have to seek additional financing from public and
private sale of our securities, including equity securities.
There can be no assurance that additional funding will be
available when needed or on acceptable terms.
Our principal contractual obligations were comprised of the
following as of June 30, 2005 (in thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Within | |
|
Within | |
|
|
| |
|
|
|
Within | |
|
1-4 | |
|
4-7 | |
|
After 7 | |
| |
|
Total | |
|
1 Year | |
|
Years | |
|
Years | |
|
Years | |
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
Long-term debt obligations
|
|
$ |
9 |
|
|
$ |
9 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
Capital lease obligation
|
|
|
65 |
|
|
|
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease obligations
|
|
|
40,754 |
|
|
|
6,822 |
|
|
|
13,417 |
|
|
|
11,145 |
|
|
|
9,370 |
|
|
Purchase obligations
|
|
|
3,968 |
|
|
|
3,368 |
|
|
|
390 |
|
|
|
210 |
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Total
|
|
$ |
44,796 |
|
|
$ |
10,264 |
|
|
$ |
13,807 |
|
|
$ |
11,355 |
|
|
$ |
9,370 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in the total minimum payments for operating leases is
approximately $5.2 million related to unoccupied real
estate in California which was accrued as a liability, net of
contractual sublease income, as a part of the Companys
restructuring actions (see Restructuring charges below).
Purchase obligations are comprised primarily of outsourced
preclinical and clinical trial expenses and payments to license
certain intellectual property to support the Companys
research efforts.
11
Critical Accounting Policies and Estimates
A critical accounting policy is one which is both
important to the portrayal of the Companys financial
condition and results and requires managements most
difficult, subjective or complex judgments, often as a result of
the need to make estimates about the effect of matters that are
inherently uncertain. See the discussion in our significant
accounting policies in Note 2 to the Consolidated Financial
Statements included in our Annual Report on Form 10-K for
additional information.
|
|
|
Revenue recognition compound development
revenue |
Historically, we have entered into various chemistry-based
collaborative agreements with pharmaceutical and biotechnology
companies under which we produce and deliver compound arrays and
perform other research and development services. Revenue from
collaborative agreements includes non-refundable technology
transfer fees, funding of compound development work, payments
based upon delivery of specialized compounds meeting the
collaborators specified criteria, and certain milestones
and royalties on product sales. Non-refundable technology
transfer fees are recognized as revenue when we have the
contractual right to receive such payment, provided a
contractual arrangement exists, the contract price is fixed or
determinable, the collection of the resulting receivable is
reasonably assured and we have no further performance
obligations under the license agreement. When we have
performance obligations under the terms of a contract,
non-refundable fees are recognized as revenue as we complete our
obligations. Where our level of effort is relatively constant
over the performance period, the revenue is recognized on a
straight-line basis. Funding of compound development work is
recognized over the term of the applicable contract using the
proportional achievement of deliveries against a compound
delivery schedule or the development labor expended against a
total research and development labor plan as the measure of
progress toward completion. Any significant changes in the
assumptions underlying our estimates to complete a contract
(e.g., changes in the number of person hours to develop
compounds, or changes in throughput capacity of our machinery
and equipment) could impact our revenue recognition. Payments
based upon delivery of specialized compounds meeting the
collaborators specified criteria are recognized as revenue
when these compounds are delivered and payment by the
collaborator is reasonably assured. Revenues from milestone
payments related to chemistry-based collaboration arrangements
under which we have no continuing performance obligations are
recognized upon achievement of the related milestone. Revenues
from milestone payments related to arrangements under which we
have continuing performance obligations are recognized as
revenue upon achievement of the milestone only if all of the
following conditions are met: the milestone payments are
non-refundable; achievement of the milestone was not reasonably
assured at the inception of the arrangement; substantive effort
is involved in achieving the milestone; and the amount of the
milestone is reasonable in relation to the effort expended or
the risk associated with achievement of the milestone. If any of
these conditions are not met, the milestone payments are
deferred and recognized as revenue over the term of the
arrangement as we complete our performance obligations. Payments
received under these arrangements prior to the completion of the
related work are recorded as deferred revenue. The Company
applies Emerging Issues Task Force No. 00-21, Accounting
for Revenue Arrangements with Multiple Deliverables
(EITF 00-21), to determine if a contract with
multiple deliverables has more than one unit of accounting.
Compound development revenue was derived from the following
contractual elements for the six months ended June 30, 2005
and 2004 (in thousands):
| |
|
|
|
|
|
|
|
|
| |
|
2005 | |
|
2004 | |
| |
|
| |
|
| |
|
Non-refundable technology transfer payments
|
|
$ |
5 |
|
|
$ |
5 |
|
|
Funding of compound development
|
|
|
235 |
|
|
|
1,143 |
|
|
Payments based on delivery of specialized compounds
|
|
|
23,853 |
|
|
|
22,223 |
|
|
Milestone payments
|
|
|
|
|
|
|
750 |
|
| |
|
|
|
|
|
|
|
Total compound development revenue
|
|
$ |
24,093 |
|
|
$ |
24,121 |
|
| |
|
|
|
|
|
|
12
|
|
|
Revenue recognition research and development
revenue |
On April 2, 2004, we announced an alliance with Roche to
discover and develop drug candidates targeting the E2F
biological pathway. The alliance includes a compound which is
currently in phase 1 clinical development. Under the terms
of the agreement, Roche obtained an option to license our E2F
program in the field of cancer therapy. Roche provided immediate
research funding of $15 million and is providing financial
support for ongoing research and development. We are responsible
for advancing drug candidates from early stage development into
phase 2 trials. Roche may exercise its option to license
worldwide rights for the development and commercialization of
products resulting from this collaboration by paying an option
fee. Assuming the successful development and commercialization
of a compound under the program, we could receive up to
$276 million in pre-determined payments, plus royalties
based on net sales. We consider the development portion of the
arrangement to be a single unit of accounting for the purposes
of revenue recognition, and we will recognize the initial and
ongoing development payments as research and development revenue
on a straight-line basis over the maximum estimated development
period. We estimate the maximum development period could extend
until December 2009, although this period may ultimately be
shorter depending upon the outcome of the development work,
which would result in accelerated recognition of the development
revenue. Milestone and royalty payments will be recognized as
revenue when earned. The cost associated with satisfying the
Roche contract is included in research and development expense
in the Condensed Consolidated Statement of Operations as
incurred.
Results of Operations
Three months (Q2) and six months ended June 30, 2005 and
2004:
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/ | |
| |
|
|
|
|
|
(Decrease) | |
| |
|
|
|
|
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
For the three months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Compound development revenue
|
|
$ |
11.8 |
|
|
$ |
12.4 |
|
|
$ |
(0.6 |
) |
|
|
(5 |
)% |
| |
Research and development revenue
|
|
|
1.7 |
|
|
|
1.7 |
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Total revenue
|
|
$ |
13.5 |
|
|
$ |
14.0 |
|
|
$ |
(0.6 |
) |
|
|
(4 |
)% |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
For the six months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Compound development revenue
|
|
$ |
24.1 |
|
|
$ |
24.1 |
|
|
$ |
|
|
|
|
|
|
| |
Research and development revenue
|
|
|
3.3 |
|
|
|
1.7 |
|
|
|
1.7 |
|
|
|
100 |
% |
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Total revenue
|
|
$ |
27.4 |
|
|
$ |
25.8 |
|
|
$ |
1.6 |
|
|
|
6 |
% |
| |
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in compound development revenue in the second
quarter of 2005 from the second quarter of 2004 reflects
reductions in revenue from Sankyo of $0.3 million and
Novartis of $0.3 million, whose contracts ended in June
2004 and February 2005, respectively. Pfizer revenue was
approximately $11.7 million in Q2 2005 and Q2 2004.
Total compound development revenue was flat in the first six
months of 2005 compared to the same six month period of 2004, as
an increase in Pfizer revenue to $23.9 million in 2005 from
$22.2 million in 2004 was offset by a.) reductions in
revenue from Sankyo of $0.6 million and from Novartis of
$0.3 million, as these contracts ended in June 2004 and
February 2005 respectively, and b.) a reduction in revenue from
Wyeth of $0.8 million relating to a contractual milestone
payment received in the first quarter of 2004. Research and
development revenue is comprised of revenue from Roche in
connection with our alliance agreement. The Company recognized
three months of revenue under the Roche agreement in 2004 and
six months in 2005.
13
|
|
|
Cost of revenue compound development and gross
margin percentage |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/(Decrease) | |
| |
|
|
|
|
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
For the three months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Cost of revenue-compound development
|
|
$ |
7.7 |
|
|
$ |
7.5 |
|
|
$ |
0.2 |
|
|
|
3 |
% |
| |
Compound development gross margin %
|
|
|
35.0 |
% |
|
|
39.6 |
% |
|
|
|
|
|
|
(4.6 |
)% |
|
For the six months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Cost of revenue-compound development
|
|
$ |
15.0 |
|
|
$ |
16.0 |
|
|
$ |
(1.0 |
) |
|
|
(6 |
)% |
| |
Compound development gross margin %
|
|
|
37.6 |
% |
|
|
33.7 |
% |
|
|
|
|
|
|
4.0 |
% |
Cost of compound development revenue in the second quarter of
2005 increased slightly over the same period of 2004. Gross
margin percentage, which tends to vary from quarter to quarter,
decreased in the second quarter of 2005 from the second quarter
of 2004 due to the inclusion in Q2 2004 of $0.6 million of
revenue from Sankyo and Novartis with no associated cost of
revenue. Cost of compound development revenue for the six months
ended June 30, 2005 decreased from the same period of 2004
due to cost savings associated with lower headcount, lower
material and supply costs, improved manufacturing yields and
lower facility costs. Gross margins for the first six months of
2005 increased due primarily to improved manufacturing yields
and other cost savings in the first quarter of 2005.
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/(Decrease) | |
| |
|
|
|
|
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
For the three months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Research and development
|
|
$ |
6.2 |
|
|
$ |
4.7 |
|
|
$ |
1.5 |
|
|
|
32 |
% |
|
For the six months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Research and development
|
|
$ |
12.1 |
|
|
$ |
9.7 |
|
|
$ |
2.4 |
|
|
|
25 |
% |
Our research and development expense consists primarily of:
salaries and related expenses; costs of contract manufacturing
services; costs of facilities and equipment; fees paid to
professional service providers in conjunction with our clinical
trials; fees paid to research organizations in conjunction with
preclinical animal studies; costs of materials used in research
and development; consulting, license, and sponsored research
fees paid to third parties; and depreciation of capital
resources. We expect our research and development expense to
increase as we continue to develop our portfolio of oncology
programs
We have not accumulated and tracked our internal historical
research and development costs or our personnel and
personnel-related costs on a program-by-program basis. Our
employee and infrastructure resources are allocated across
several projects, and many of our costs are directed to broadly
applicable research endeavors. As a result, we cannot state the
costs incurred for each of our oncology programs on a
program-by-program basis, or the costs to support our alliance
agreement with Roche. The expenses incurred by us to third
parties for preclinical and clinical trials since inception of
each program were as follows (in thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Current | |
|
|
|
|
| Oncology Program |
|
Status | |
|
2005-to-Date | |
|
Program-to-Date | |
| |
|
| |
|
| |
|
| |
|
E2F modulation ARQ501
|
|
|
Phase 1 |
|
|
$ |
1,121 |
|
|
$ |
3,133 |
|
|
E2F modulation 550 series
|
|
|
Preclinical |
|
|
|
15 |
|
|
|
98 |
|
|
Cancer Survival Protein modulation 650 series
|
|
|
Preclinical |
|
|
|
1,658 |
|
|
|
1,937 |
|
Our future research and development expenses in support of our
current and future oncology programs will be subject to numerous
uncertainties in timing and cost to completion. We test
potential products in numerous preclinical studies for safety,
toxicology, and signs of potential efficacy. We then may conduct
14
multiple clinical trials for each product. As we obtain results
from trials, we may elect to discontinue or delay clinical
trials for certain products in order to focus our resources on
more promising products. Completion of clinical trials may take
several years or more, and the length of time generally varies
substantially according to the type, complexity, novelty, and
intended use of a product. It is not unusual for the preclinical
and clinical development of these types of products to each take
nine years or more, and for total development costs to exceed
$500 million for each product.
We estimate that clinical trials of the type generally needed to
secure new drug approval are typically completed over the
following timelines:
| |
|
|
|
|
| |
|
Estimated | |
| |
|
Completion | |
| Clinical Phase |
|
Period | |
| |
|
| |
|
Phase 1
|
|
|
1-2 years |
|
|
Phase 2
|
|
|
2-3 years |
|
|
Phase 3
|
|
|
2-4 years |
|
The duration and the cost of clinical trials may vary
significantly over the life of a project as a result of
differences arising during clinical development, including,
among others, the following:
|
|
|
| |
|
the number of clinical sites included in the trials; |
| |
| |
|
the length of time required to enroll suitable patient subjects; |
| |
| |
|
the number of patients that ultimately participate in the trials; |
| |
| |
|
the duration of patient follow-up to ensure the absence of
long-term adverse events; and |
| |
| |
|
the efficacy and safety profile of the product. |
An element of our business strategy is to pursue the research
and development of a broad pipeline of products. This is
intended to allow us to diversify the risks associated with our
research and development expenditures. As a result, we believe
our future capital requirements and future financial success are
not substantially dependent on any one product. To the extent we
are unable to maintain a broad pipeline of products, our
dependence on the success of one or a few products increases.
Our strategy includes the option of entering into alliance
arrangements with third parties to participate in the
development and commercialization of our products, such as our
collaboration agreement with Roche. In the event that third
parties have control over the clinical trial process for a
product, the estimated completion date would largely be under
control of that third party rather than under our control. We
cannot forecast with any degree of certainty whether our
products will be subject to future collaborative arrangements or
how such arrangements would affect our development plans or
capital requirements.
As a result of the uncertainties discussed above, we are unable
to determine the duration and completion costs of our oncology
programs or when and to what extent we will receive cash inflows
from the commercialization and sale of a product. Our inability
to complete our oncology programs in a timely manner or our
failure to enter into collaborative agreements, when
appropriate, could significantly increase our capital
requirements and could adversely impact our liquidity. These
uncertainties could force us to seek additional, external
sources of financing from time-to-time in order to continue with
our strategy. Our inability to raise additional capital, or to
do so on terms reasonably acceptable to us, would jeopardize the
future success of our business.
The increases in total research and development expense for the
three and six months ended June 30, 2005 versus the same
periods of 2004 are primarily due to costs of pre-clinical and
clinical studies for advancement of the Companys oncology
programs, which increased by $1.3 million and
$1.7 million, respectively. The remainder of the increases
relates to headcount and laboratory related expenses as the
Company increases its internal research and development efforts.
15
|
|
|
Marketing, general and administrative |
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/(Decrease) | |
| |
|
|
|
|
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
For the three months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Marketing, general and administrative
|
|
$ |
2.2 |
|
|
$ |
2.2 |
|
|
|
|
|
|
|
1 |
% |
|
For the six months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Marketing, general and administrative
|
|
$ |
4.9 |
|
|
$ |
4.8 |
|
|
$ |
0.1 |
|
|
|
2 |
% |
Marketing, general and administrative expense was essentially
flat period-over-period.
In the first quarter of 2004, we implemented a restructuring to
shift resources from our chemical technologies business to our
oncology therapy research and development. The restructuring
included the termination of 53 staff and managerial employees,
or approximately 18% of the workforce, in the following areas:
30 in chemistry production positions, 7 in chemistry-based
research and development positions and 16 in administrative
positions. In connection with these actions we recorded a
restructuring charge of $1.1 million in the first quarter
of 2004 for all termination benefits, which were paid in 2004.
In 2002, the Company recorded a restructuring charge associated
with abandoning its facility in Redwood City, California. The
remaining facility-related restructuring accrual is primarily
comprised of the difference between the Companys lease
obligation for this facility, which will be paid out through
2010, and the amount of sublease payments it will receive under
its sublease agreement. Current year activity against the
facility-related restructuring accrual was as follows (in
thousands):
| |
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
Balance as of | |
|
|
|
Balance as of | |
| |
|
December 31, 2004 | |
|
Payments | |
|
June 30, 2005 | |
| |
|
| |
|
| |
|
| |
|
Facility-related accrual
|
|
$ |
3,421 |
|
|
$ |
(462 |
) |
|
$ |
2,959 |
|
Net investment income
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/(Decrease) | |
| |
|
|
|
|
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
For the three months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net investment income
|
|
$ |
0.5 |
|
|
$ |
0.2 |
|
|
$ |
0.3 |
|
|
|
102 |
% |
|
For the six months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net investment income
|
|
$ |
1.0 |
|
|
$ |
0.4 |
|
|
$ |
0.6 |
|
|
|
141 |
% |
Net investment income increased due to a higher average balance
of marketable securities as a result of the $28.3 million
net proceeds from our stock offering in January 2005 and
$39.4 million net proceeds from the sale of our Woburn
facility in May 2005.
Loss on investment
In Q2 2005, the Company reassessed the carrying value of its
investment in a privately-owned proteomics company. Based on
events affecting the financial condition of the company during
the second quarter of 2005 we concluded that the value of the
investment had declined to the degree of other than temporary
impairment, and as such, we recorded a non-cash loss on
investment of $250,000 to fully write-off the carrying value.
16
Net loss
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
Increase/(Decrease) | |
| |
|
|
|
|
|
| |
| |
|
2005 | |
|
2004 | |
|
$ | |
|
% | |
| |
|
| |
|
| |
|
| |
|
| |
| |
|
(In millions) | |
|
For the three months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net loss
|
|
$ |
(2.4 |
) |
|
$ |
(0.1 |
) |
|
$ |
2.3 |
|
|
|
1,711 |
% |
|
For the six months ended June 30:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Net loss
|
|
$ |
(3.9 |
) |
|
$ |
(5.4 |
) |
|
$ |
(1.5 |
) |
|
|
(28 |
)% |
The increase in net loss for the three months ended
June 30, 2005 compared to the same period of 2004 reflects
the decrease in compound development revenue, increased research
and development spending and the loss on investment, partially
offset by increased net investment income. The decrease in net
loss for the six months ended June 30, 2005 is primarily
due to the $1.1 million restructuring charge in the first
quarter of 2004. Also contributing to the reduction in net loss
in 2005 is the increase in research and development revenue,
reduction in cost of compound development revenue and increased
net investment income, partially offset by the increase in
research and development expense.
Forward Looking Statements
This report, including the Managements Discussion and
Analysis of Financial Condition and Results of Operation
(MD&A), contains statements reflecting
managements current expectations regarding our future
performance. These statements are forward looking
statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
statements also may be included in other statements that we
make. All statements that are not descriptions of historical
fact are forward-looking statements, based on estimates,
assumptions and projections that are subject to risks and
uncertainties. These statements can generally be identified by
use of forward looking terminology such as believes,
expects, intends, may,
will, should, anticipates or
similar terminology. Although we believe that the expectations
reflected in such forward looking statements are reasonable as
of the date thereof, such expectations are based on certain
assumptions regarding the progress of product development
efforts under collaborative agreements, the execution of new
collaborative agreements and other factors relating to our
growth. Such expectations may not materialize if product
development efforts, including any necessary trials of our
potential drug candidates, are delayed or suspended, if positive
early results are not repeated in later studies or in humans, if
planned acquisitions or negotiations with potential
collaborators are delayed or unsuccessful, if we are
unsuccessful at integrating acquired assets or technologies or
if other assumptions prove incorrect. As a result, actual
results could differ materially from those currently
anticipated. See also the risks and uncertainties discussed in
our Annual Report on Form 10-K for the year ended
December 31, 2004 filed with the Securities and Exchange
Commission on March 16, 2005.
|
|
| Item 3. |
Quantitative and Qualitative Disclosures About Market
Risk |
As part of our investment portfolio we own financial instruments
that are sensitive to market risk. Our investment portfolio is
used to preserve our capital until it is used to fund
operations, including our research and development activities.
None of these market-risk sensitive instruments are held for
trading purposes. We invest our cash primarily in money market
mutual funds and U.S. federal and state agency backed
obligations and other investment grade debt securities. These
investments are evaluated quarterly to determine the fair value
of the portfolio. Our investment portfolio includes only
marketable securities with active secondary or resale markets to
help ensure liquidity. We have implemented policies regarding
the amount and credit ratings of investments. Due to the
conservative nature of these policies, we do not believe we have
material exposure from market risk.
The carrying amounts reflected in the consolidated balance sheet
of cash and cash equivalents, trade receivables, and trade
payables approximate fair value at June 30, 2005 due to the
short-term maturities of these instruments.
17
|
|
| Item 4. |
Controls and Procedures |
Under the supervision and with the participation of the
Companys President and Chief Executive Officer and Chief
Financial Officer (its principal executive officer and principal
accounting and financial officer), the Company has evaluated the
effectiveness of the design and operation of its disclosure
controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Securities and Exchange Act of 1934). Based
on that evaluation, the President and Chief Executive Officer
and Chief Financial Officer have concluded that these disclosure
controls and procedures as of June 30, 2005 are effective
in recording, processing, summarizing and reporting the
financial results of the Companys operations. There were
no changes in the Companys internal controls and
procedures over financial reporting during the quarter ended
June 30, 2005 that have materially affected, or are
reasonably likely to materially affect, the internal control
over financial reporting.
PART II OTHER INFORMATION
|
|
| Item 1 |
Legal Proceedings. |
None.
|
|
| Item 2 |
Changes in Securities and Use of Proceeds. |
None.
|
|
| Item 3 |
Defaults Upon Senior Securities. |
None.
|
|
| Item 4 |
Submission of Matters to a Vote of Security
Holders. |
At the Annual Meeting of the Stockholders held on May 18,
2005, the Companys stockholders voted as follows:
|
|
| |
1. To elect William G. Messenger and Patrick J. Zenner as
directors to hold office for a term of three years and until
their respective successors are elected and qualified; |
| |
|
|
|
|
| |
|
For |
|
Withheld |
| |
|
|
|
|
|
William G. Messenger
|
|
27,166,108 |
|
2,416,062 |
|
Patrick J. Zenner
|
|
24,656,774 |
|
4,925,396 |
|
|
| |
2. To approve an amendment to the Companys Amended
and Restated 1994 Equity Incentive Plan to increase the
aggregate number of shares of common stock that may be issued
under the plan by 1,300,000 shares from 8,300,000 to
9,600,000 shares; |
| |
|
|
|
|
|
|
|
|
|
|
| For |
|
Against |
|
Abstain |
|
Broker Non-Vote |
| |
|
|
|
|
|
|
|
9,091,903
|
|
6,388,486 |
|
|
37,155 |
|
|
|
14,064,626 |
|
|
|
| |
3. To approve an amendment to the Companys Amended
and Restated 1996 Director Stock Option Plan to increase
the aggregate number of shares of common stock that may be
issued under the plan by 150,000 shares from 350,500 to
500,500 shares; |
| |
|
|
|
|
|
|
|
|
|
|
| For |
|
Against |
|
Abstain |
|
Broker Non-Vote |
| |
|
|
|
|
|
|
|
12,925,071
|
|
2,555,378 |
|
|
37,095 |
|
|
|
14,064,626 |
|
18
|
|
| |
4. To approve an amendment to the Companys Amended
and Restated 1996 Employee Stock Purchase Plan to increase the
aggregate number of shares of common stock that are available
for purchase under the plan by 210,000 shares from
1,020,000 to 1,230,000 shares; and |
| |
|
|
|
|
|
|
|
|
|
|
| For |
|
Against |
|
Abstain |
|
Broker Non-Vote |
| |
|
|
|
|
|
|
|
14,918,164
|
|
569,386 |
|
|
29,995 |
|
|
|
14,064,625 |
|
|
|
| |
5. To ratify and confirm the appointment by the
Companys Audit Committee of PricewaterhouseCoopers LLP, an
independent registered public accounting firm, to serve as the
Companys independent auditors for the fiscal year ending
December 31, 2005. |
| |
|
|
|
|
|
|
| For |
|
Against |
|
Abstain |
| |
|
|
|
|
|
29,422,160
|
|
136,013 |
|
|
23,997 |
|
At the close of business on April 1, 2005, the record date
for the determination of shareholders entitled to vote at the
Meeting, there were 34,783,481 shares of the Companys
Common Stock, each share being entitled to one vote,
constituting all of the outstanding voting securities of the
Company. At the Meeting, the holders of 29,582,170 shares
of the Companys Common Stock were represented in person or
by proxy constituting a quorum.
|
|
| Item 5 |
Other Information. |
None.
| |
|
|
|
|
| |
10 |
.21 |
|
Amended and Restated Lease by and Between ARE-MA Region
No. 20, LLC and ArQule, Inc dated June 30, 2005. |
| |
| |
31 |
.1 |
|
Rule 13a-14(a) Certificate of Chief Executive Officer |
| |
| |
31 |
.2 |
|
Rule 13a-14(a) Certificate of Chief Financial Officer |
| |
| |
32 |
|
|
Rule 13a-14(b) Certificate of Chief Executive Officer and
Chief Financial Officer |
19
ARQULE, INC.
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.
|
|
| |
ARQULE, INC. |
| |
| |
/s/ Louise A. Mawhinney
|
| |
|
| |
Louise A. Mawhinney |
| |
Vice President, Chief Financial Officer, Treasurer and
Secretary |
Date: August 4, 2005
20