BOULDER, Colo., Feb 05, 2007 (BUSINESS WIRE) -- Array BioPharma Inc. (NASDAQ: ARRY) today reported financial
results for the second quarter of fiscal 2007.
Array reported revenue of $7.6 million for the second quarter of
fiscal 2007, compared to revenue of $11.9 million for the same period
in fiscal 2006. This resulted from shifting resources from external
funded research to advance and expand Array's internal proprietary
drug discovery programs. In addition, in the same quarter last year,
Array recognized license and milestone payments from AstraZeneca and
Genentech. These payments have been fully recognized prior to this
quarter. Today, Array is advancing four wholly owned drugs in clinical
development and a portfolio of discovery programs. As a result,
Array's investment in proprietary research and development reached
$14.8 million, nearly twice the investment in research and development
compared to the same quarter last year. Array reported a net loss of
$15.9 million, or ($0.40) per share, for the second quarter, compared
to a net loss of $8.7 million, or ($0.23) per share, for the same
quarter in fiscal 2006. Array ended the second quarter of fiscal 2007
with $84.4 million in cash, cash equivalents and marketable
securities.
Array initiated a focused effort on creating and developing its
own drugs in 2002. Over the past four years, Array has increased its
investment in proprietary research, producing a pipeline of five drugs
in clinical development and a growing portfolio of discovery programs.
Array's disciplined use of capital has created this portfolio of
products with a modest investment of $118 million since the inception
of the Company.
"We made tremendous progress during 2006, achieving our goal of
having five drugs in clinical development by year-end," said Robert E.
Conway, Chief Executive Officer, Array BioPharma. "Over the next 12
months, we anticipate having catalysts on six wholly owned Array
drugs, including advancing two drugs into Phase 2 clinical trials and
filing two additional INDs."
Second Quarter and Subsequent Accomplishments:
-- Array held its first Analyst Day on December 5, 2006 in New
York City and reviewed five major development programs. A
webcast of the event is available on Array's website:
www.arraybiopharma.com.
Advancing Proprietary Research Programs
-- ARRY-886 (AZD6244), a novel MEK inhibitor, continued in
randomized Phase 2 studies initiated by AstraZeneca in
patients with malignant melanoma, colorectal, pancreatic or
non-small cell lung cancers.
-- Advanced ARRY-543, an oral, selective, reversible, small
molecule tyrosine kinase inhibitor of both ErbB-2 (Her-2/neu)
and EGFR, in a Phase 1 clinical trial. Array reported positive
Phase 1 interim results at its Analyst Day on December 5,
2006: The compound demonstrated good drug exposure, and four
patients had stable disease at well-tolerated doses.
-- Continued a Phase 1 clinical trial in healthy volunteers for
Array's first-in-class MEK inhibitor for inflammatory disease,
ARRY-162. There have been no serious adverse events through 14
days of continuous dosing and cytokine production was
significantly inhibited after ex-vivo stimulation of clinical
samples. Array presented these results at the 14th
International Inflammation Research Association Conference on
October 19, 2006.
-- Initiated a Phase 1b combination trial with ARRY-162 and
methotrexate in rheumatoid arthritis patients, which will
evaluate safety, tolerability, pharmacokinetics, biomarkers
and initial signs of efficacy.
-- Initiated a Phase 1 clinical trial in healthy volunteers for
Array's lead p38 inhibitor, ARRY-797, for inflammatory
disease, which will evaluate safety, tolerability,
pharmacokinetics and biomarkers.
-- Filed an IND which is now effective for ARRY-520, a small
molecule Kinesin Spindle Protein (KSP) inhibitor, and
anticipate starting a Phase 1 clinical trial for cancer
patients during the first half of 2007.
Partnered Research
-- InterMune, Inc. initiated patient dosing in January 2007 on a
Phase 1a clinical trial with ITMN-191, an orally available
hepatitis C virus (HCV) protease inhibitor, entitling Array to
a $500,000 milestone payment to be recognized in the quarter
ending March 31, 2007.
Strengthening Clinical Leadership
-- Expanded capabilities in clinical development. Array hired
Sandra Rojas-Caro, M.D., as Director of Exploratory Medicine.
She has previous experience from Pfizer in the fields of
metabolic and inflammatory diseases. Dr. Rojas-Caro will help
lead Array's inflammation clinical portfolio in translational
medicine, incorporating the latest biomarker and biomedical
techniques.
Array reported revenue of $18.6 million for the six-month period
ended December 31, 2006, compared to revenue of $23.2 million for the
same period in fiscal 2006. Net loss for the six months ended December
31, 2006, was $24.1 million, or ($0.61) per share, compared to a net
loss of $18.4 million, or ($0.48) per share, reported in the same
period in fiscal 2006.
Array will hold a conference call on Tuesday, February 6, 2007, 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
Date: Tuesday, February 6, 2007
Time: 9:00 a.m. Eastern time
Toll-Free: 800-500-0177
Toll: 719-457-2679
Pass Code: 4367554
Web Cast: www.arraybiopharma.com
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 4367554.
About Array BioPharma:
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small
molecule drugs to treat life threatening and debilitating diseases.
Our proprietary drug development pipeline is focused on the treatment
of cancer and inflammatory disease and includes clinical candidates
that are designed to regulate therapeutically important targets. 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 that
involve significant risks and uncertainties, including those discussed
in our annual report filed on form 10-K for the year ended June 30,
2006, 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 5, 2007. 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)
Three Months Ended Six Months Ended
December 31, December 31,
------------------ -------------------
2006 2005 2006 2005
--------- -------- --------- ---------
Revenue:
Collaboration revenue $7,546 $9,232 $15,535 $17,515
License and milestone revenue 12 2,708 3,049 5,667
--------- -------- --------- ---------
Total revenue 7,558 11,940 18,584 23,182
Operating expenses (a)
Cost of revenue (1) 6,218 10,013 12,485 19,403
Research and development for
proprietary
drug discovery (2) 14,785 7,802 25,638 16,427
Selling, general and
administrative expenses (3) 3,283 3,379 6,252 6,833
--------- -------- --------- ---------
Total operating expenses 24,286 21,194 44,375 42,663
--------- -------- --------- ---------
Loss from operations (16,728) (9,254) (25,791) (19,481)
Interest expense (249) (153) (489) (282)
Interest income 1,105 696 2,177 1,380
--------- -------- --------- ---------
Net loss $(15,872) $(8,711) $(24,103) $(18,383)
========= ======== ========= =========
Basic and diluted net loss per
share $(0.40) $(0.23) $(0.61) $(0.48)
========= ======== ========= =========
Number of shares used to
compute per share data 39,471 38,617 39,309 38,557
========= ======== ========= =========
(a) Includes stock-based
compensation expense
(1) Cost of revenue $262 $546 $591 $1,071
(2) Research and development
for proprietary
drug discovery 411 320 781 733
(3) Selling, general and
administrative expenses 518 799 1,021 1,607
--------- -------- --------- ---------
Total $1,191 $1,665 $2,393 $3,411
========= ======== ========= =========
Summary Balance Sheet Data
(in thousands)
Dec. 31, June 30,
2006 2006
-------- ---------
Cash, cash equivalents and
marketable securities $84,400 $70,100
Property, plant and equipment,
gross 68,245 66,139
Working capital 68,220 56,008
Total assets 114,614 102,173
Long term debt 15,000 14,150
Stockholders' equity 50,285 68,641
SOURCE: Array BioPharma Inc.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
