BOULDER, Colo.--(BUSINESS WIRE)--
Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for
the second quarter of the Company’s 2009 fiscal year ending December 31,
2008.
FINANCIAL RESULTS
Array reported revenue of $7.7 million for the second quarter of fiscal
2009, compared to revenue of $8.4 million for the same period in fiscal
2008. Array invested $23.7 million in research and development for the
quarter to advance its eight wholly-owned drugs in clinical development
and select discovery programs. This compares to $20.5 million invested
in research and development during the same quarter of fiscal 2008.
Array reported a net loss of $37.8 million, or ($0.79) per share, for
the second quarter, compared to a net loss of $20.4 million, or ($0.43)
per share, for the same quarter in fiscal 2008. The second quarter of
fiscal 2009 loss included $10.5 million or $0.22 per share loss due to a
mark-to-market write-down of auction rate securities. Array ended the
second quarter of fiscal 2009 with $100.0 million in cash, cash
equivalents and marketable securities.
Array reported revenue of $13.4 million for the six-month period ended
December 31, 2008, compared to revenue of $15.0 million for the same
period in fiscal 2008. Net loss for the six months ended December 31,
2008, was $71.5 million, or ($1.50) per share, compared to a net loss of
$39.4 million, or ($0.84) per share, reported in the same six-month
period in fiscal 2008.
SUMMARY OF RECENT PROGRESS
“Over the past month, we put in place multiple measures to conserve
capital and focus our resources on advancing eight promising clinical
programs in cancer, inflammation and diabetes through clinical proof of
concept,” said Robert E. Conway, Chief Executive Officer. “We anticipate
having proof of concept or Phase 1 clinical results on all eight of our
clinical programs in 2009. We also announced three exciting discovery
programs, one or more of which could advance into clinical development
this year.”
Initiating clinical development of a novel glucokinase activator for
Type II diabetes
During the first quarter of calendar 2009, Array plans to initiate Phase
1 clinical development with ARRY-403, a novel glucokinase activator. At
a recent scientific meeting, Array reported that ARRY-403 demonstrates
potent, highly glucose-blood-level dependent control of both fasting and
non-fasting glucose concentrations.
Advancing programs for the treatment of chronic inflammatory disease
and pain
Array initiated a worldwide, 170-patient, 12-week Phase 2 clinical trial
with ARRY-797, a p38 inhibitor, in patients with ankylosing spondylitis
and continued a dose escalation trial with ARRY-797 to test tolerability
of up to 1200 mg daily in a sub-chronic setting for 7 days. Array is
also on track with recruitment of a 28-day Phase 1b trial of ARRY-797 in
patients with stable rheumatoid arthritis taking methotrexate. Array
announced the achievement of both the primary and secondary endpoints
from a 250-patient Phase 2 acute inflammatory dental pain study
evaluating the analgesic efficacy of ARRY-797 at the 2008 ACR/ARHP
Annual Scientific Meeting.
Array’s MEK inhibitor for inflammation, ARRY-162, continued a worldwide,
200-patient, 12-week Phase 2 trial with ARRY-162 added to methotrexate
in patients with rheumatoid arthritis. Over 100 patients have been
enrolled to date and complete enrollment is expected in the first
quarter of calendar 2009.
Array initiated dosing ARRY-300, a targeted small molecule MEK
inhibitor, in a Phase 1 clinical trial. The Phase 1 clinical trial is a
randomized, single-blind, placebo-controlled, single-ascending dose
study to evaluate the safety, pharmacokinetics and pharmacodynamics of
ARRY-300 in healthy volunteers.
Progressing four novel clinical candidates for cancer
Array is in the process of initiating sites in a Phase 1b/2 trial of
ARRY-520, a novel KSP inhibitor, in patients with multiple myeloma.
Array is continuing a Phase 1 trial of ARRY-520 in patients with solid
tumors and a Phase 1b/2 trial of ARRY-520 in patients with acute
myelogenous leukemia (AML).
Array is planning a Phase 1b trial of ARRY-614, our p38/Tie-2 inhibitor,
in patients with myelodysplastic syndromes (MDS) to determine the
safety, maximum tolerated dose, pharmacokinetics and preliminary
estimates of efficacy of the compound in this patient population. This
study is expected to begin during the second quarter 2009. Array
recently completed a Phase 1 clinical trial with ARRY-614 in a single
and multiple dose escalation study in healthy volunteers for safety,
tolerability, exposure and inhibition of mechanism related biomarkers.
Array continued a Phase 1b expansion trial for ARRY-543, our ErbB-2/EGFR
inhibitor. Half of the patients in this trial have trastuzumab-resistant
ErbB2-positive metastatic breast cancer and half of the patients have
other ErbB-family-driven cancers. Results from this trial are
anticipated in the first half of 2009. Array is also continuing a Phase
1b trial of ARRY-543 in combination with Xeloda® (capecitabine) in
patients with solid tumors. Array anticipates initiating two additional
Phase 1b trials, in combination with Taxotere® (docetaxel) and Gemzar®
(gemcitabine), respectively, in the first half of calendar 2009.
Recruitment in a Phase 1 safety trial of ARRY-380, a selective, oral
ErbB-2 inhibitor, remains on track. This trial is expected to be
complete in 2009.
Unveiling three discovery programs
At the JP Morgan Healthcare conference, Array disclosed three discovery
candidates:
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Chk-1 -- a first in class, selective, oral inhibitor for the treatment
of cancer;
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Trk -- a first in class, selective, oral inhibitor for the treatment
of pain; and
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PDGFR -- a best in class, selective, oral inhibitor for the treatment
of fibrosis.
Secured a milestone payment on one of Array’s many partnered programs
Array received a $1 million milestone payment from VentiRx for VTX-2337,
a toll-like receptor agonist, entering Phase 1 clinical development for
the treatment of cancer. Array licensed its toll-like receptor program
to VentiRx in 2007 and retains the option to acquire a 50% ownership
position in all clinical oncology products developed under this
agreement.
FINANCIAL GUIDANCE
In early January 2009, Array announced plans to accelerate partnering
initiatives and to scale back discovery research spending over the next
24 months. During calendar 2009, Array expects to reduce net cash used
in operating activities from the previously planned $30 million per
quarter to approximately $20 million per quarter, before new partner or
milestone payments.
CONFERENCE CALL DETAILS
Array will hold a conference call on Tuesday, February 3, 2009, at 9:00
a.m. eastern time to discuss these results. Robert E. Conway, Chief
Executive Officer, and Michael Carruthers, Chief Financial Officer, will
lead the call.
Conference Call Information
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Date:
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Tuesday, February 3, 2009
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Time:
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9:00 a.m. eastern time
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Toll-Free:
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877-856-1960
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Toll:
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719-325-4787
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Pass Code:
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2036041
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Web Cast:
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www.arraybiopharma.com
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A replay of the call will be available as a webcast on www.arraybiopharma.com
and by phone for one week by dialing toll-free (888) 203-1112 or (719)
457-0820. The access code is 2036041.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small molecule
drugs to treat patients afflicted with cancer, inflammatory and
metabolic diseases. Our proprietary drug development pipeline includes
clinical candidates that are designed to regulate therapeutically
important target proteins and are aimed at significant unmet medical
needs. In addition, leading pharmaceutical and biotechnology companies
collaborate with Array to discover and develop drug candidates across a
broad range of therapeutic areas. For more information on Array, please
go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our future plans for advancing certain of our
proprietary drug programs, the potential to earn future milestone
payments, license fees or royalty revenue, and the plans of our
collaborators to further develop drugs we have out-licensed or on which
we are collaborating. These statements involve significant risks and
uncertainties, including those discussed in our annual report filed on
form 10-K for the year ended June 30, 2008, and in other reports filed
by Array with the Securities and Exchange Commission. Because these
statements reflect our current expectations concerning future events,
our actual results could differ materially from those anticipated in
these forward-looking statements as a result of many factors. These
factors include, but are not limited to, our ability to continue to fund
and successfully progress internal research efforts and to create
effective, commercially viable drugs, our ability to achieve and
maintain profitability, the extent to which the pharmaceutical and
biotechnology industries are willing to in-license drug candidates for
their product pipelines and to collaborate with and fund third parties
on their drug discovery activities, our ability to out-license our
proprietary candidates on favorable terms, risks associated with our
dependence on our collaborators for the clinical development and
commercialization of our out-licensed drug candidates, the ability of
our collaborators and of Array to meet objectives tied to milestones and
royalties, and our ability to attract and retain experienced scientists
and management. We are providing this information as of February 2,
2009. We undertake no duty to update any forward-looking statements to
reflect the occurrence of events or circumstances after the date of such
statements or of anticipated or unanticipated events that alter any
assumptions underlying such statements.
Array BioPharma Inc. Condensed Statements of Operations (in
thousands, except per share amounts) (Unaudited)
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Three Months Ended
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Six Months Ended
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December 31,
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December 31,
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2008
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2007
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2008
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2007
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Revenue:
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Collaboration revenue
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$
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5,041
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$
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5,634
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$
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9,278
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$
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11,255
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License and milestone revenue
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2,648
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2,784
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4,158
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|
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3,756
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Total revenue
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7,689
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8,418
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13,436
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15,011
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Operating expenses
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Cost of revenue
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5,063
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5,240
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10,183
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10,553
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Research and development for proprietary
drug discovery
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23,709
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20,548
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48,218
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38,167
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General and administrative
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4,480
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4,830
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8,974
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9,207
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Total operating expenses
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33,252
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30,618
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67,375
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57,927
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|
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Loss from operations
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(25,563
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)
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(22,200
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)
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(53,939
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)
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(42,916
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)
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Impairment of marketable securities
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(10,452
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)
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-
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(14,362
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)
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-
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Interest income
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|
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533
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|
|
|
2,032
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|
|
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1,413
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|
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3,939
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Interest expense
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(2,336
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)
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(219
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)
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(4,616
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)
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(464
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)
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Net loss
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$
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(37,818
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)
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$
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(20,387
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)
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$
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(71,504
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)
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$
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(39,441
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)
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Basic and diluted net loss per share
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$
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(0.79
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)
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$
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(0.43
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)
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$
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(1.50
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)
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$
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(0.84
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)
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Number of shares used to compute per share data
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47,605
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47,174
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47,589
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47,142
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|
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|
|
|
|
|
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Summary Balance Sheet Data (in thousands)
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December 31,
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June 30,
|
|
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2008
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2008
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|
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Cash, cash equivalents and marketable securities
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$
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99,954
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$
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125,531
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Property, plant and equipment, gross
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83,018
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|
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81,966
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Working capital
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54,265
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66,346
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Total assets
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136,467
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163,077
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Long-term debt
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78,844
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35,355
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Stockholders' (deficit) equity
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(26,979
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)
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38,027
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Source: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com