Array BioPharma Inc. (NASDAQ: ARRY) today reported financial results for
the fourth quarter and full year of fiscal 2009.
Array reported revenue of $5.5 million for the fourth quarter of fiscal
2009, compared to revenue of $6.1 million for the same period in fiscal
2008. Array invested $21.3 million in proprietary research and
development for the quarter to advance its seven wholly-owned drugs in
clinical development and select discovery programs. This compares to
$28.4 million invested in research and development during the fourth
quarter of fiscal 2008. Array reported a net loss of $26.7 million, or
($0.55) per share, for the fourth quarter, compared to a net loss of
$32.4 million, or ($0.68) per share, for the fourth quarter in fiscal
2008. Array ended the fourth quarter of fiscal 2009 with $57.5 million
in cash, cash equivalents and marketable securities. In addition, Array
received $40.0 million in capital from Deerfield Private Design Fund,
L.P. and Deerfield Private Design International, L.P. (collectively the
“Deerfield Funds”) on August 5, 2009 under a loan facility agreement
dated May 15, 2009.
Array reported revenue of $25.0 million for the fiscal year ended June
30, 2009, compared to revenue of $28.8 million for fiscal 2008. Net loss
for the fiscal year ended June 30, 2009, was $127.8 million, or ($2.67)
per share, compared to a net loss of $96.3 million, or ($2.04) per
share, reported in fiscal 2008. Array invested $89.6 million in
proprietary research and development for the year, compared to $90.3
million for fiscal 2008.
“We are pleased to report positive results from our Phase 1 clinical
trial of ARRY-403 in patients with Type 2 diabetes,” said Robert E.
Conway, Chief Executive Officer. “There are 24 million Type 2 diabetic
patients in the U.S. with the incidence of the disease accelerating at
an alarming rate. Many of these patients are unable to control their
glucose levels with existing therapy and need better approaches to
manage their disease. ARRY-403 provides a unique mechanism of action for
controlling diabetes with the potential to address this critical unmet
medical need. We have initiated an aggressive development program, while
also seeking a partner to maximize ARRY-403’s benefit to patients.”
SUMMARY OF RECENT PROGRESS
Clinical trial completed in
Type 2 diabetic patients:
ARRY-403 – GK activator for
Type 2 diabetes: Array announced positive top-line data from a Phase
1 clinical trial in patients with Type 2 diabetes with its novel small
molecule glucokinase activator (GKA), ARRY-403. The drug met its primary
and secondary endpoints of safety, pharmacokinetics and glucose control.
Additional data is available from Array BioPharma’s website at www.arraybiopharma.com
Six clinical programs advanced for the treatment of cancer:
ARRY-162
– MEK inhibitor for cancer: Array filed an investigational new drug
application with the FDA and is now able to proceed with a Phase 1
clinical trial in cancer patients with its most advanced wholly-owned
MEK inhibitor, ARRY-162. Recent publications have shown that the MEK
pathway acts as a central axis in the proliferation of different tumors
including melanoma, non-small cell lung, colorectal and pancreatic
cancers. The Phase 1 dose escalation study is designed to evaluate
safety, pharmacokinetics and pharmacodynamics of ARRY-162 following
daily oral administration to patients with advanced solid tumors.
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 two Phase 1/2 trials in patients with acute myelogenous
leukemia and multiple myeloma, respectively.
ARRY-614 - p38/Tie-2 Inhibitor for MDS: In March 2009, Array
reported data from a Phase 1 clinical trial with ARRY-614 in a single
and multiple dose-escalation study in healthy subjects. This study
showed that ARRY-614 was well tolerated and exhibited dose-dependent
increases in exposure and strong evidence of pharmacodynamic activity.
Based on this data and strong biological support for testing a p38
inhibitor in myelodysplastic syndromes (MDS), Array is dosing patients
with MDS in a Phase 1 trial with ARRY-614 to determine the safety,
maximum tolerated dose, pharmacokinetics and preliminary estimates of
efficacy of the compound in this patient population.
ARRY-543 - ErbB family inhibitor for solid tumors: Array
completed enrollment in a Phase 1b trial with ARRY-543 in patients with
ErbB2+ metastatic breast cancer and other ErbB-expressing tumors. Array
continued a Phase 1 dose-escalation study with tablet formulation in
patients with solid tumors and a Phase 1b trial in combination with
Xeloda® (capecitabine) in patients with solid tumors. Array initiated
dosing patients in two additional Phase 1b trials, in combination with
Taxotere® (docetaxel) and Gemzar® (gemcitabine).
ARRY-380 - ErbB2 selective inhibitor for cancer: Patient
recruitment in a Phase 1 trial with ARRY-380, an oral, selective
ErbB2 (Her2) inhibitor, remains on track to complete enrollment this
year. The trial is designed to evaluate the safety and pharmacokinetics
of ARRY-380 in patients with advanced cancer and to establish the
maximum tolerated dose.
ARRY-300 – MEK inhibitor: Array completed enrollment in 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. ARRY-300 will be a
back-up for ARRY-162.
Two clinical program updates for the treatment of chronic
inflammatory disease and pain:
ARRY-162 - MEK inhibitor for
RA: Array completed a 12 week Phase 2, randomized, double-blind,
placebo controlled global proof-of-concept trial with ARRY 162 in
patients with active RA who were receiving stable doses of methotrexate
for ≥ 6 weeks. Top-line results are expected to be available in
September 2009.
ARRY-797 - p38 inhibitor for AS: Array announced top-line results
from its Phase 1, seven-day, dose escalation trial up to 1,200 mg daily
of ARRY-797 in healthy volunteers. In addition, the top-line results
were announced in a second study, where ARRY-797 was evaluated in a
28-day Phase 1b trial in stable RA patients taking methotrexate. A
preliminary analysis of both trials indicates that ARRY-797 was
well-tolerated with a pharmacokinetic profile consistent with earlier
studies. In the 28-day, three-arm RA study with a total of 28 patients,
ARRY-797 showed inhibition of CRP levels (marker of inflammation) only
during the first three weeks of dosing and a beneficial reduction in NTx
levels (marker of bone remodeling) throughout the study. In addition,
ARRY-797 showed a trend to improve the patients’ assessment of pain (VAS
score) over the course of the study.
Array continues to conduct a full analysis of safety, pharmacokinetics
and efficacy data from both studies and anticipates that complete
results from the studies will be presented at a medical conference in
2010. Based on these preliminary results, Array has discontinued the
enrollment of new patients in its clinical trial of ARRY-797 in
ankylosing spondylitis. Array is evaluating alternative development
paths in sub-chronic pain and supportive care indications.
Array’s Information Technology Platform recognized by CIO
magazine: IDG's CIO magazine announced Array as a recipient
of the 2009 CIO 100. The 22nd annual award program recognizes
organizations around the world that exemplify the highest level of
operational and strategic excellence in information technology.
Array received additional capital: Array received $40.0 million
in additional capital from the Deerfield Funds on August 5, 2009 under a
loan facility agreement dated May 15, 2009. The outstanding principal
under the new loan is due by April 2014 and interest is payable monthly.
Principal and interest can be repaid, at Array’s option, at any time
with shares of Array common stock.
Array will hold a conference call on Tuesday, August 11, 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, August 11, 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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888-726-2459
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Toll:
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913-312-0977
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Pass Code:
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6778402
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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 6778402.
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 August 10, 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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(Unaudited)
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(in thousands, except per share amounts)
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Three Months Ended June 30,
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Year Ended June 30,
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2009
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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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$ 3,801
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$ 4,645
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$ 17,228
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$ 21,513
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License and milestone revenue
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1,706
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1,441
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7,754
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7,295
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Total revenue
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5,507
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6,086
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24,982
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28,808
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Operating expenses
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Cost of revenue
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4,157
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5,086
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19,855
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21,364
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Research and development for proprietary drug discovery
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21,313
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28,350
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89,560
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90,347
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General and administrative
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4,587
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2,647
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18,020
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15,591
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Total operating expenses
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30,057
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36,083
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127,435
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127,302
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Loss from operations
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(24,550
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)
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(29,997
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(102,453
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)
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(98,494
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)
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Other income (expense)
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Impairment of marketable securities
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-
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(1,872
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(17,742
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(1,872
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Interest income
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296
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783
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2,116
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6,064
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Interest expense
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(2,736
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(1,351
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(10,024
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(1,986
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Total other income
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(2,440
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(2,440
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(25,650
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2,206
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Loss before income tax benefit
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(26,990
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(32,437
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(128,103
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(96,288
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)
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Income tax benefit
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288
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-
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288
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-
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Net loss
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$ (26,702
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$ (32,437
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$ (127,815
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$ (96,288
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Weighted average shares outstanding -
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basic and diluted
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48,119
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47,529
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47,839
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47,309
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Net loss per share - basic and diluted
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$ (0.55
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$ (0.68
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$ (2.67
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$ (2.04
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Summary Balance Sheet Data
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(in thousands)
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June 30,
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June 30,
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2009
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2008
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Cash, cash equivalents and marketable securities
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$ 57,488
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$ 125,531
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Property, plant and equipment, gross
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$ 83,683
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$ 80,878
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Working capital
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$ (5,378
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$ 66,346
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Total assets
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$ 95,055
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$ 163,077
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Long-term debt, net
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$ 68,170
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$ 35,355
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Stockholders' equity
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$ (73,701
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$ 38,027
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Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com