ArQule, Inc. : ArQule Reports Second Quarter 2012 Financial Results
08/02/2012| 07:05am US/Eastern
Recommend:
Conference call scheduled today at 9:00 a.m. eastern time
ArQule, Inc. (NASDAQ: ARQL) today announced its financial results for
the second quarter of 2012.
For the quarter ended June 30, 2012, the Company reported a net loss of
$885,000 or $0.01 per share, compared with a net loss of $10,804,000 or
$0.20 per share, for the second quarter of 2011. For the six-month
period ended June 30, 2012, the Company reported a net loss of
$5,145,000 or $0.09 per share, compared to a net loss of $12,270,000 or
$0.24 per share, for the six-month period ended June 30, 2011.
At June 30, 2012, the Company had a total of approximately $147,068,000
in cash, equivalents and marketable securities.
Operational Update
-
Completion of patient recruitment in the randomized, double-blind
Phase 3 MARQUEE pivotal trial of tivantinib in second-line patients
with non-squamous, non-small cell lung cancer (NSCLC);
-
Presentation of randomized Phase 2 data at the 2012 Annual Meeting of
the American Society of Clinical Oncology (ASCO) highlighting
significant clinical benefits observed in second-line hepatocellular
carcinoma (HCC) patients with MET-high tumors treated with tivantinib
as a single agent;
-
Presentations of Phase 1 data at the 2012 Annual Meeting of ASCO
highlighting evidence of the clinical benefit and safety of tivantinib
in combination with sorafenib in cohorts of patients with HCC, renal
cell carcinoma and melanoma.
"The timely completion of patient recruitment in the MARQUEE trial marks
an important milestone in the development of tivantinib in non-squamous
cell non-small cell lung cancer, a disease with a high unmet need for
additional effective treatment options," said Paolo Pucci, chief
executive officer of ArQule. "Approximately 1,000 patients from more
than 200 clinical sites worldwide are participating in this trial, which
is being conducted under a Special Protocol Assessment in the U.S.
"Findings presented recently at ASCO represent the first randomized data
reported in HCC with an investigational MET inhibitor as single-agent
therapy in second-line treatment," said Mr. Pucci. "Based on the
positive clinical results in previously treated HCC patients with
MET-high tumors, planning is underway for a Phase 3 trial in this
population."
Revenues and Expenses
The Company reported total revenues of $11,829,000 for the quarter ended
June 30, 2012, compared to revenues of $5,447,000 for the second quarter
of 2011. Revenues for the six months ended June 30, 2012 were
$20,327,000 compared to revenues of $18,852,000 for the six months ended
June 30, 2011.
The $6.4 million revenue increase in the 2012 three month period is due
to revenue increases of $1.7 million from the Company's Daiichi Sankyo
AKIPTM agreement, $0.8 million from our Daiichi Sankyo ARQ
092 agreement, $0.2 million from our Kyowa Hakko Kirin tivantinib
license agreement, and lower contra-revenue of $3.7 million.
The $1.5 million revenue increase in the six month period is due to
increases of $4.2 million from our Daiichi Sankyo AKIPTM
agreement, $1.6 million from our Daiichi Sankyo ARQ 092 agreement, $0.6
million from our Kyowa Hakko Kirin license agreement and lower
contra-revenue of $5.3 million. These increases were partially offset by
a $10.2 million decrease in revenue recognized from the $25 million
MARQUEE milestone payment received from Daiichi Sankyo in the first
quarter of 2011. In the six months ended June 30, 2011 when we received
that milestone payment, we recognized revenue of $12.7 million compared
with $2.5 million in the six months ended June 30, 2012, resulting in a
revenue decrease of $10.2 million.
Total costs and expenses for the quarter ended June 30, 2012 were
$12,785,000 compared to $16,388,000 for the second quarter of 2011.
Total costs and expenses for the six months ended June 30, 2012 were
$25,687,000 compared to $31,324,000 for the same period in 2011.
Research and development costs for the three and six-month periods ended
June 30, 2012 were $9,271,000 and $18,574,000 respectively, compared
with $12,836,000 and $24,229,000 for the 2011 three and six-month
periods. The lower research and development costs and expenses in the
2012 periods were due to lower outsourced clinical and product
development costs related to our Phase 1 and Phase 2 programs for
tivantinib.
General and administrative costs for the three and six-month periods
ended June 30, 2012 were $3,514,000 and $7,113,000 respectively,
compared with $3,552,000 and $7,095,000 for the 2011 three and six-month
periods.
Confirmed Financial Guidance
As previously stated, for 2012 ArQule expects net use of cash to range
between $39 and $44 million. Revenues are expected to range between $40
and $45 million. Net loss is expected to range between $15 and $20
million. Net loss per share is expected to range between $(0.25) and
$(0.33) for 2012. ArQule expects to end 2012 with between $121 and $126
million in cash and marketable securities.
|
Conference Call and Webcast
|
|
|
|
|
|
|
|
Date:
|
|
Thursday, August 2, 2012
|
|
Time:
|
|
9:00 a.m. Eastern Time
|
|
Conference Call Numbers
|
|
|
|
Domestic:
|
|
877-868-1831
|
|
International:
|
|
914-495-8595
|
|
Web cast:
|
|
http://investors.arqule.com/events.cfm
|
A replay of the conference call will be available for seven days
following the call and can be accessed by dialing toll-free 855-859-2056
and outside the U.S. 404-537-3406. The replay access code is 99910692.
About ArQule
ArQule is a biotechnology company engaged in the research and
development of next-generation, small-molecule cancer therapeutics. The
Company's targeted, broad-spectrum products and research programs are
focused on key biological processes that are central to human cancers.
ArQule's lead product, in Phase 2 and Phase 3 clinical development, is
tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor
tyrosine kinase. The Company has also initiated Phase 1 clinical testing
with ARQ 621, designed to inhibit the Eg5 kinesin motor protein, and
with ARQ 736, designed to inhibit the RAF kinases. ArQule's current
discovery efforts, which are based on the ArQule Kinase Inhibitor
Platform (AKIP?), are focused on the identification of novel kinase
inhibitors that are potent, selective and do not compete with ATP
(adenosine triphosphate) for binding to the kinase.
This press release contains forward-looking statements regarding the
Company's clinical trials with tivantinib (ARQ 197) and other candidate
compounds in earlier stages of development, as well as forward-looking
statements related to the Company's financial guidance for 2012
(including estimates of net use of cash, revenues, net loss, net loss
per share and cash and marketable securities at the end of 2012) and its
agreements with Daiichi Sankyo Co., Ltd. and Kyowa Hakko Kirin. These
statements are based on the Company's current beliefs and expectations,
and are subject to risks and uncertainties that could cause actual
results to differ materially. Positive information about
pre-clinical and early stage clinical trial results does not ensure that
later stage or larger scale clinical trials will be successful. For
example, tivantinib, ARQ 621 (an Eg5 inhibitor) and ARQ 736 (a RAF
kinases inhibitor) may not demonstrate promising therapeutic effects; in
addition, they may not demonstrate appropriate safety profiles in
current or later stage or larger scale clinical trials as a result of
known or as yet unanticipated side effects. The results achieved in
later stage trials may not be sufficient to meet applicable regulatory
standards or to justify further development. Problems or delays may
arise during clinical trials or in the course of developing, testing or
manufacturing these compounds that could lead the Company or its
partners to discontinue development. Even if later stage clinical
trials are successful, unexpected concerns may arise from analysis of
data or from additional data. Obstacles may arise or issues may be
identified in connection with review of clinical data with regulatory
authorities, and regulatory authorities may disagree with the Company's
view of the data or require additional data or information or additional
studies. In addition, the planned timing of initiation and
completion of clinical trials for tivantinib is subject to the ability
of the Company or Daiichi Sankyo, its partner, and Kyowa Hakko Kirin, a
licensee of tivantinib, to enroll patients, enter into agreements with
clinical trial sites and investigators, and overcome other technical
hurdles and issues related to the conduct of the trials for which each
of them is responsible that may not be resolved. Drug development
involves a high degree of risk. Only a small number of research and
development programs result in the commercialization of a product. Positive
pre-clinical data may not be supported in later stages of development.
Furthermore, ArQule may not have the financial or human resources to
successfully pursue drug discovery in the future. Moreover,
Daiichi Sankyo has certain rights to unilaterally terminate the
tivantinib license, co-development and co-commercialization agreement.
If it were to do so, the Company might not be able to complete
development and commercialization of tivantinib on its own. For more
detailed information on the risks and uncertainties associated with the
Company's drug development and other activities, see the Company's
periodic reports filed with the Securities and Exchange Commission. The
Company does not undertake any obligation to publicly update any
forward-looking statements.
|
|
|
ArQule, Inc.
Condensed Consolidated Statements of Operations and
Comprehensive Loss
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
|
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
|
|
|
|
(In Thousands, Except Per Share Data)
|
|
|
|
|
|
|
|
Research and development revenue
|
|
$
|
11,829
|
|
$
|
5,447
|
|
$
|
20,327
|
|
$
|
18,852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
9,271
|
|
|
12,836
|
|
|
18,574
|
|
|
24,229
|
|
|
General and administrative
|
|
|
3,514
|
|
|
3,552
|
|
|
7,113
|
|
|
7,095
|
|
|
Total costs and expenses
|
|
|
12,785
|
|
|
16,388
|
|
|
25,687
|
|
|
31,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(956
|
)
|
|
(10,941
|
)
|
|
(5,360
|
)
|
|
(12,472
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
79
|
|
|
112
|
|
|
144
|
|
|
167
|
|
|
Interest expense
|
|
|
(6
|
)
|
|
(6
|
)
|
|
(12
|
)
|
|
(12
|
)
|
|
Other income (expense)
|
|
|
(2
|
)
|
|
31
|
|
|
83
|
|
|
47
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(885
|
)
|
|
(10,804
|
)
|
|
(5,145
|
)
|
|
(12,270
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities
|
|
|
(126
|
)
|
|
101
|
|
|
(107
|
)
|
|
64
|
|
|
Comprehensive loss
|
|
$
|
(1,011
|
)
|
$
|
(10,703
|
)
|
$
|
(5,252
|
)
|
$
|
(12,206
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
$
|
(0.01
|
)
|
$
|
(0.20
|
)
|
$
|
(0.09
|
)
|
$
|
(0.24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average basic and diluted common shares outstanding
|
|
|
60,891
|
|
|
53,255
|
|
|
57,351
|
|
|
51,961
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Research and development revenue is shown net of collaboration
contra-revenue of zero and $3.4 million and $3.7 million and $8.7
million for the three and six months ended June 30, 2012 and 2011,
respectively.
|
|
|
|
|
|
|
Balance sheet data (in thousands):
|
|
June 30,
2012
|
|
December 31,
2011
|
|
|
|
|
|
|
|
Cash, equivalents and marketable securities- short term
|
|
$
|
75,089
|
|
$
|
68,168
|
|
Marketable securities- long term
|
|
71,979
|
|
40,475
|
|
|
|
$
|
147,068
|
|
$
|
108,643
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
152,259
|
|
$
|
117,051
|
|
|
|
|
|
|
|
|
|
Notes payable
|
|
$
|
1,700
|
|
$
|
1,700
|
|
|
|
|
|
|
|
|
|
Stockholders' equity
|
|
$
|
84,232
|
|
$
|
29,729
|
ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor
Relations/
Corp. Communications
www.ArQule.com
© Business Wire 2012
Recommend :
