BOULDER, Colo.--(BUSINESS WIRE)--May. 4, 2009--
Array BioPharma Inc. (NASDAQ:ARRY) today reported financial results for
the third quarter ended March 31, 2009.
FINANCIAL RESULTS
Array reported revenue of $6.0 million for the third quarter of fiscal
2009, compared to revenue of $7.7 million for the same period in fiscal
2008. Array invested $20.0 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 $23.8 million invested
in research and development during the third quarter of fiscal 2008.
Array reported a net loss of $29.6 million, or ($0.62) per share, for
the third quarter, compared to a net loss of $24.4 million, or ($0.51)
per share, for the third quarter in fiscal 2008. The third quarter of
fiscal 2009 loss included $3.4 million or $0.07 per share loss due to a
mark-to-market write-down of auction rate securities. Array ended the
third quarter of fiscal 2009 with $72.9 million in cash, cash
equivalents and marketable securities.
Array reported revenue of $19.5 million for the nine-month period ended
March 31, 2009, compared to revenue of $22.7 million for the same period
in fiscal 2008. Net loss for the nine months ended March 31, 2009, was
$101.1 million, or ($2.12) per share, compared to a net loss of $63.9
million, or ($1.35) per share, reported in the same nine-month period in
fiscal 2008.
SUMMARY OF RECENT PROGRESS
“We had a total of 18 presentations and publications on Array-invented
drugs at the 2009 AACR conference last month demonstrating the progress
we’ve made advancing our oncology pipeline,” said Robert E. Conway,
Chief Executive Officer. “During the quarter, we also initiated dosing
on an exciting glucokinase activator, ARRY-403, for Type II diabetes
patients. We anticipate having proof of concept or Phase 1 clinical
results on all eight of our clinical programs in 2009.”
Clinical trial initiated in Type II diabetic patients:
ARRY-403 – GK activator for Type II diabetes: Array
initiated dosing Type II diabetic patients in a Phase 1 clinical trial
with its novel small molecule glucokinase activator (GKA), ARRY-403. In
the Phase 1 trial, the compound is being evaluated in a single-dose
escalation study to evaluate safety, tolerability, pharmacokinetics and
blood glucose control. In preclinical studies, ARRY-403 demonstrated
effective control of both fasting and non-fasting blood glucose
concentrations, and was shown to be highly dependent on blood glucose
concentrations.
Three clinical programs advanced for the treatment of chronic
inflammatory disease and pain:
ARRY-797 - p38 inhibitor for AS: Array continued a worldwide,
126-patient, 12-week Phase 2 proof-of-concept clinical trial with
ARRY-797, a p38 inhibitor, in patients with ankylosing spondylitis (AS).
Array also completed a dose escalation trial with ARRY-797 to test
tolerability of up to 1200 mg daily in a sub-chronic setting for seven
days and completed enrollment of a 28-day Phase 1b trial of ARRY-797 in
patients with stable rheumatoid arthritis (RA) taking methotrexate.
ARRY-162 - MEK inhibitor for RA: Array completed patient
enrollment in a worldwide, 200-patient, 12-week Phase 2 proof-of-concept
clinical trial with ARRY-162, a MEK inhibitor, added to methotrexate in
patients with rheumatoid arthritis.
ARRY-300 – MEK inhibitor: Array completed a Phase 1 trial with
ARRY-300, a targeted small molecule MEK inhibitor. The Phase 1 trial was
a randomized, single-blind, placebo-controlled, single-ascending dose
study to evaluate the safety, pharmacokinetics and pharmacodynamics of
ARRY-300 in healthy volunteers.
Four clinical programs advanced for the treatment of cancer & were
presented at the American Association for Cancer Research (AACR)
conference:
ARRY-520 – KSP inhibitor for AML & MM: Array continued a
Phase 1 trial of ARRY-520, a novel KSP inhibitor, in patients with solid
tumors and Phase 1/2 trials of ARRY-520 in patients with acute
myelogenous leukemia (AML) and in patients with multiple myeloma (MM).
AACR Highlights: Preclinical hematological tumor models were
particularly responsive to treatment with ARRY-520, with a 100 percent
complete response rate observed in AML, acute promyelocytic leukemia,
and MM xenografts. Treatment of MM xenografts with ARRY-520 resulted in
significant regression of tumors that had previously progressed after
treatment with Velcade® (bortezomib) or Revlimid® (lenalidomide). In
addition, ARRY-520 retained activity in a wide range of tumors resistant
to other molecules with different mechanisms of action, such as the
taxanes. Examination of pharmacodynamic activity in preclinical models
reinforced that hematological cancers were among the most sensitive to
ARRY-520.
ARRY-614 - p38 / Tie-2 inhibitor for MDS: Array is planning a
Phase 1b trial of ARRY-614, a 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 of 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.
AACR Highlights: In preclinical hematological tumor models,
ARRY-614 demonstrated activity both as a single agent and in combination
with Revlimid® (lenalidomide). Results show that ARRY-614 was
well-tolerated and effective in inhibiting cytokines, including IL-6 and
TNF, which play a role in the regulation of growth and survival in a
number of cancers, particularly hematological cancers. As a single
agent, ARRY-614 effectively inhibited angiogenesis in vivo and
inhibited tumor growth in preclinical models of MM. Additionally, data
show that administering p38 inhibitors in combination with lenalidomide
yielded superior inhibition of proinflammatory cytokines and that
combining ARRY-614 with standard-of-care agents, lenalidomide and
Decadron® (dexamethasone), in MM provided additional anti-tumor effects.
ARRY-543 - ErbB-2 / EGFR inhibitor for solid tumors: Array
continued its Phase 1b trial of ARRY-543 in combination with Xeloda®
(capecitabine) in patients with solid tumors. Array initiated two
additional Phase 1b trials, in combination with Taxotere® (docetaxel)
and Gemzar® (gemcitabine).
AACR Highlights: Preliminary results presented on Array’s Phase 1
trial showed that ARRY-543 was generally well-tolerated and demonstrated
evidence of tumor regression and prolonged stable disease in EGFR- and
ErbB2-expressing cancers. Of the confirmed patients with ErbB2-positive
metastatic breast cancer treated with ARRY-543, 63 percent achieved
stable disease for 16 weeks or longer. Twenty one patients were
evaluated: 12 had available biopsies and eight were confirmed
ErbB2-positive. Clinical benefit was demonstrated in five of these eight
patients and patients with confirmed co-expression of ErbB2 and EGFR
tended to have the best clinical benefit. In patients with other cancers
shown to express ErbB family members, three patients, with ovarian
cancer, cervical cancer and cholangiocarcinoma, respectively, treated
with ARRY-543 also achieved stable disease for 16 weeks or more; the
patient with cholangiocarcinoma experienced a tumor marker response that
was accompanied by a 25 percent regression of target lesions.
ARRY-380 – ErbB-2 inhibitor for cancer: Patient recruitment in a
Phase 1 trial of ARRY-380, an oral, selective ErbB-2 inhibitor, remains
on track to complete in 2009. The trial is designed to evaluate the
safety, maximum tolerated dose, and pharmacokinetics of ARRY-380 in
cancer patients.
CONFERENCE CALL DETAILS
Array will hold a conference call on Tuesday, May 5, 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.
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Conference Call Information
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Date:
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Tuesday, May 5, 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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877-856-1964
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Toll:
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719-325-4815
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Pass Code:
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2844590
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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 2844590.
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 May 4, 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.
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Array BioPharma Inc.
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Condensed Statements of Operations
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(in thousands, except per share amounts)
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(Unaudited)
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|
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|
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Three Months Ended
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Nine Months Ended
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March 31,
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March 31,
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|
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2009
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|
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2008
|
|
|
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2009
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2008
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Revenue:
|
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Collaboration revenue
|
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$
|
4,399
|
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|
$
|
5,613
|
|
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$
|
13,427
|
|
|
$
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16,868
|
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|
License and milestone revenue
|
|
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1,639
|
|
|
|
2,098
|
|
|
|
6,047
|
|
|
|
5,854
|
|
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Total revenue
|
|
|
6,038
|
|
|
|
7,711
|
|
|
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19,474
|
|
|
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22,722
|
|
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|
|
|
|
|
|
|
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Operating expenses
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Cost of revenue
|
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5,515
|
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|
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5,725
|
|
|
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15,698
|
|
|
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16,278
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Research and development for proprietary drug discovery
|
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20,029
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23,830
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68,248
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|
|
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61,997
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General and administrative
|
|
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4,461
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|
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3,737
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|
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13,435
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|
|
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12,944
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Total operating expenses
|
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30,005
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|
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33,292
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|
|
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97,381
|
|
|
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91,219
|
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|
|
|
|
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|
|
|
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Loss from operations
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(23,967
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)
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(25,581
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)
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(77,907
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)
|
|
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(68,497
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)
|
|
|
|
|
|
|
|
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Impairment of marketable securities
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|
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(3,381
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)
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-
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(17,742
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)
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-
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Interest income
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412
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|
|
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1,342
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|
|
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1,823
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|
|
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5,281
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Interest expense
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(2,674
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)
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(171
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)
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(7,289
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)
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(635
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)
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Net loss
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$
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(29,610
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)
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$
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(24,410
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)
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$
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(101,115
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)
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$
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(63,851
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)
|
|
|
|
|
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Basic and diluted net loss per share
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$
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(0.62
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)
|
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$
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(0.51
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)
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$
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(2.12
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)
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$
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(1.35
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)
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Number of shares used to compute per share data
|
|
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48,068
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|
|
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47,428
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47,747
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|
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47,236
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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Summary Balance Sheet Data
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(in thousands)
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|
|
|
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|
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March 31,
|
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June 30,
|
|
|
|
|
|
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|
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2009
|
|
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2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cash, cash equivalents and marketable securities
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$
|
72,932
|
|
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$
|
125,531
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|
|
|
|
|
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Property, plant and equipment, gross
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|
$
|
83,455
|
|
|
$
|
81,966
|
|
|
|
|
|
|
Working capital
|
|
$
|
31,480
|
|
|
$
|
66,346
|
|
|
|
|
|
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Total assets
|
|
$
|
108,493
|
|
|
$
|
163,077
|
|
|
|
|
|
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Long-term debt
|
|
$
|
80,979
|
|
|
$
|
35,355
|
|
|
|
|
|
|
Stockholders' equity (deficit)
|
|
$
|
(54,958
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)
|
|
$
|
38,027
|
|
|
|
|
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Source: Array BioPharma Inc.
Array BioPharma
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
