Array BioPharma Reports Financial Results For The Second Quarter Of Fiscal 2013

  Array BioPharma Reports Financial Results For The Second Quarter Of Fiscal
                                     2013

MEK162 Phase 3 Trial to Start April 2013

AstraZeneca Announced Selumetinib Potential Phase 3 NSCLC Trial Start in 2013

PR Newswire

BOULDER, Colo., Feb. 4, 2013

BOULDER, Colo., Feb. 4, 2013 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ:
ARRY) today reported results for the second quarter of its fiscal year ending
June 30, 2013.

(Logo: http://photos.prnewswire.com/prnh/20121029/LA02195LOGO)

Array continued its evolution into a late-stage development company, making
significant progress in generating data to support our upcoming development
for our wholly-owned hematology programs. During the quarter, Novartis
declared its intention to begin a Phase 3 trial with MEK162 in NRAS melanoma
which is now scheduled to start in April 2013. In addition, Novartis announced
plans to pursue additional MEK162 late-stage clinical development in
combination with their Raf inhibitor in BRAF mutant melanoma. Also,
AstraZeneca recently announced a potential start of a Phase 3 trial with
selumetinib in non-small cell lung cancer (NSCLC) during the second half of
2013. 

Revenue for the second fiscal quarter ended December 31, 2012 was $18.4
million, compared to $23.2 million for the same period in fiscal 2012. The
decline in revenue was due to the $28.0 million licensing payment from
Genentech during the first half of fiscal 2012 that did not recur in 2013.
Research and development expense was $13.9 million, compared to $13.2 million
in the comparable prior year period. Net loss was $10.9 million, or ($0.10)
per share for the second quarter, compared to a net loss of $3.8 million, or
($0.06) per share, for the same period in fiscal 2012.

For the six months ended December 31, 2012, revenue was $34.2 million,
compared to $45.4 million for the same period in fiscal 2012. The decline was
also related to the Genentech licensing payment described above. Net loss for
the six months ended December 31, 2012, was $22.7 million, or ($0.23) per
share, compared to a net loss of $7.4 million, or ($0.13) per share, in the
comparable prior year period.

During the quarter, Array paid Novartis its first annual co-development
contribution of $9.2 million to maintain the maximum U.S. royalty rate for
MEK162. These contributions are capped annually and in total. Array ended
the quarter with $110 million in cash, cash equivalents and marketable
securities.

Ron Squarer, Chief Executive Officer of Array, noted, "We are seeing strong
progress across our pipeline. At ASH, we presented impressive ARRY-520 data
as a single agent, in combination with dexamethasone, in combination with
carfilzomib, and on a selection marker that may identify patients more likely
to respond to ARRY-520. Our partners, Novartis with MEK162 and AstraZeneca
with selumetinib, each announced plans to progress these Array-invented
products into Phase 3 pivotal trials this year. In addition, ARRY-502 is on
track to complete enrollment by this spring with summer top-line results.
Out-licensing this product represents a potential important source of
non-dilutive funding."

KEY COMPANY AND PROGRAM UPDATES

Raised $70.9 million in public offering: Array completed an underwritten
public offering of 20.7 million shares of its common stock at a price of $3.65
per share in November 2012. Array received net proceeds from the sale of the
shares of $70.9 million. This money will be used to fund potential Phase 3 or
pivotal programs.

Elected John A. Orwin to Array's Board of Directors:  Array elected John A.
Orwin, chief executive officer of Affymax, Inc., to its board of directors as
an independent director. Previously, he held leadership roles in marketing,
sales, and operations for major pharmaceutical companies including Genentech,
Johnson & Johnson, Alza Pharmaceuticals, Rhone-Poulenc Rorer, and
Schering-Plough Corporation. Prior to joining Affymax, he had successfully
launched or grown brands such as: Avastin®, Rituxan®, Herceptin®, Tarceva® and
Taxotere®.

ARRY-520 – Advances in clinical trials, ASH data presentation, identification
of potential important biomarker

During the quarter, ARRY‑520, a potent, selective KSP inhibitor with a
mechanism of action distinct from other drugs used to treat multiple myeloma,
was advanced in three clinical trials. Positive results in any one of these
trials will define a clear path to late stage development:

1.Phase 2 trial in combination with dexamethasone in patients with MM
    refractory to Revlimid® (lenalidomide), Velcade® (bortezomib) and
    dexamethasone therapy.
2.Phase 1b trial in combination with Velcade plus dexamethasone in patients
    with relapsed or refractory MM.
3.Phase 1b investigator-sponsored trial in combination with Kyprolis®
    (carfilzomib) in patients with relapsed or refractory MM who are
    refractory or intolerant to Velcade therapy.

At the 2012 Annual Meeting of the American Society of Hematology (ASH), data
on Array's Phase 2 trial with ARRY-520 in patients with triple-refractory
multiple myeloma and a median number of 10 prior treatment regimens was
presented. ARRY-520 plus low-dose dexamethasone demonstrated a 22% overall
response rate (≥ partial response, or PR), with manageable safety. This
response rate is comparable to the response rates reported in pomalidomide and
Kyprolis studies, which included patients with only half the number of median
prior treatment regimens. Overall survival of 19 months and progression free
survival of 3.7 months were reported in multiple myeloma patients taking
ARRY-520 alone.

In addition, preclinical and clinical data suggest that AAG (acute phase
protein alpha-1-acidic glycoprotein) may be an enabling patient selection
marker for response to ARRY-520. A related presentation assessing the same
group of ARRY-520-treatedpatients observed that, for patients retrospectively
selected with a lower AAG level, the overall response rate (≥PR) increased to
33% (from 22%) with a median time on study of 6.2 months. The clinical
benefit rate (≥MR) was 50% in the selected population.

Interim data from an ongoing investigator-sponsored combination trial of
ARRY-520 with Kyprolis in patients with relapsed or refractory MM who are
refractory or intolerant to Velcade® (bortezomib) were also reported at the
conference. The combination has demonstrated early signals of activity, with
a 56% clinical benefit rate (≥MR). In addition, it has been well tolerated
with limited hematologic toxicity and a manageable side effect profile.

ARRY-614 – FDA meeting provides guidance on primary endpoint

During the quarter, Array continued toevaluate ARRY-614  in an
ongoingclinical trial in patients with low or intermediate-1 riskMDS using
an optimized formulation. As presented at ASH, this new formulation has
demonstrated improved bioavailability and target coverage in this patient
population. With this new formulation, peak plasma concentrations and overall
exposures are higher than with the original formulation. The ongoing Phase 1
dose escalation trial of the optimized ARRY-614 formulation may further our
understanding of the contributions of these targets to the pathogenesis of
MDS. In a prior study in a similar population, up to a 40% response rate for
hematologic improvement was observed in patients.

Array also met with the FDA to discuss the development plan to support
registration and received guidance from the FDA on the primary endpoint,
including a discussion of endpoints other than overall survival that could be
used as the basis for approval. Array has now defined a potential path to
registration and, pending additional positive data from the ongoing study,
will make decisions on future study designs in 2013.

ARRY-797 – Data presented at ACR meeting, biomarkers suggest disease state
modification potential

Array gave a "late-breaker" presentation at the 2012 American College of
Rheumatology Annual Meeting. The presentation included data on ARRY-797's
analgesic effect and markers of disease modification. In addition, biomarkers
of cartilage (COMP) and bone (CTX‑I) degradation were assessed. ARRY‑797
treatment resulted in statistically significant decreases in COMP and CTX‑I at
week 4 (decreases of 10% and 38% versus placebo, respectively). The decrease
in CTX‑I was sustained and returned to baseline by the follow‑up visit.
Further evaluation of the potential for disease modifying activity is
warranted.

Array announced in July 2012 that treatment with ARRY-797, a non-opioid,
resulted in a statistically significant reduction in pain over a 28-day period
compared to placebo, as measured using the Western Ontario and McMaster
Universities Arthritis Index (WOMAC®) pain subscale (a 0 – 10 numerical pain
rating scale), in a randomized, placebo-controlled and active-controlled
(oxycodone ER) Phase 2 clinical trial in osteoarthritis patients suffering
from moderate to severe knee pain despite the use of non-steroidal
anti-inflammatory drugs (NSAIDs). ARRY-797 is a novel, oral, selective
inhibitor with a mechanism of action unique from that of currently approved
pain medications. Given our internal focus on hematology/oncology, Array is
seeking a partnership to maximize the value of this drug.

MEK-162 – Phase 3 pivotal trial announced and posted by Novartis

At its R&D Investor event in November 2012, Novartis indicated that it intends
to initiate a Phase 3 pivotal trial for MEK-162 in patients with NRAS mutant
melanoma. This study was recently posted on ClinicalTrials.gov and has a
scheduled start date of April 2013. Please click here to view. Novartis has
also recently accelerated its goal of regulatory submissions for MEK162 to
2015. In addition, Novartis announced plans to pursue additional clinical
development in combination with a Raf inhibitor in BRAF mutant melanoma.

Selumetinib – AstraZeneca may initiate Phase 3 trial in 2013

AstraZeneca recently announced with their quarterly financial results that
they expect to initiate a Phase 3 selumetinib trial in 2013 in patients with
NSCLC. Selumetinib is advancing in 65 trials, 39 of which are in Phase 2.
AstraZeneca initiated a 225-patient Phase 2 randomized trial with selumetinib
in combination with docetaxel in 2nd line unselected NSCLC. The trial will
evaluate two different doses of docetaxel with selumetinib versus docetaxel
alone. We believe this will help optimize the product's profile, validate
biomarker diagnostics and generate preliminary efficacy in selective subsets
of NSCLC patients. Additionally, AstraZeneca will specifically assess efficacy
within KRAS subgroups in terms of progression free survival, overall survival,
overall response rate and change in tumor size at week 6.

In addition to NSCLC, positive results were presented last year with
selumetinib in thyroid and ovarian cancers. In a Phase 2 trial in recurrent
low-grade serous ovarian or peritoneal cancer, patients taking selumetinib
showed a disease control rate of 81%, defined as either complete or partial
response or progression-free survival or progression-free survival of greater
than 6 months. Eight patients had complete (1) or partial (7) responses. The
median survival rate without cancer progression was 11 months. And in
patients with thyroid cancer, selemetinib showed a 71% partial response and
91% mean reduction in tumor growth. In this study, selumetinib resensitized
patients to radioactive iodine to warrant further therapy.

CONFERENCE CALL INFORMATION

Array will hold a conference call on Tuesday, February 5, 2013, at 9:00 a.m.
eastern time to discuss these results. Ron Squarer, Chief Executive Officer,
and Michael Carruthers, Chief Financial Officer, will lead the call.

Conference Call Information
Date:                             Tuesday, February 5, 2013
Time:                            9:00 a.m. eastern time
Toll-Free:                           (800) 447-0521
Toll:                             (847) 413-3238
Pass Code:                            34113160
Webcast & Conference Call Slides:
http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-irhome

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. Array is evolving into a late-stage
development company with significant progress toward generating data to
support our upcoming Phase 3 / pivotal trial decisions. Array-invented MEK162
will begin testing in a Phase 3 trial in NRAS melanoma in April 2013 as well
as BRAF mutant melanoma later in the year (with Novartis). Also, AstraZeneca
announced they may start a Phase 3 trial with selumetinib in non-small cell
lung cancer during the second half of 2013. Three other Array invented drugs
are also approaching Phase 3 decisions by the end of calendar year 2013. These
include Array's wholly-owned drugs, ARRY-520 and ARRY-614, and one partnered
program, danoprevir (with InterMune/Roche). 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 the timing of the announcement of the results of clinical trials for our
proprietary and our partnered programs, the timing of the completion or
initiation of further development of our wholly-owned and our partnered
programs, expectations that events will occur that will result in greater
value for the Company, the potential for the results of ongoing preclinical
and clinical trials to support regulatory approval or the marketing success of
a drug candidate, our ability to partner our proprietary drug candidates for
up-front fees, milestone and/or royalty payments, our future plans to progress
and develop our proprietary programs and the plans of our collaborators to
progress and develop programs we have licensed to them, and our plans to build
a late-stage development company. These statements involve significant risks
and uncertainties, including those discussed in our most recent annual report
filed on Form 10-K, in our quarterly reports filed on Form 10-Q, 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 and development efforts and to create effective,
commercially viable drugs; 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
BioPharma Inc. to meet objectives tied to milestones and royalties; our
ability to effectively and timely conduct clinical trials in light of
increasing costs and difficulties in locating appropriate trial sites and in
enrolling patients who meet the criteria for certain clinical trials; risks
associated with our dependence on third-party service providers to
successfully conduct clinical trials within and outside the United States; our
ability to achieve and maintain profitability and maintain sufficient cash
resources; 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; and
our ability to attract and retain experienced scientists and management. We
are providing this information as of February 4, 2013. 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
(Unaudited)
(in thousands, except per share amounts)
                                   Three Months Ended    Six Months Ended
                                   December 31,          December 31,
                                   2012       2011       2012       2011
Revenue
  License and milestone revenue    $       $       $       $   
                                   14,016     19,195     26,492     37,657
  Collaboration revenue            4,361      4,033      7,718      7,701
      Total revenue                18,377     23,228     34,210     45,358
Operating expenses
  Cost of revenue                  7,909      6,266      14,448     12,711
  Research and development for
  proprietary programs             13,941     13,150     27,475     25,748
  General and administrative       4,610      3,782      9,390      7,502
      Total operating expenses     26,460     23,198     51,313     45,961
Loss from operations               (8,083)    30         (17,103)   (603)
Other income (expense)
  Interest income                  12         3          24         9
  Interest expense                 (2,860)    (3,836)    (5,619)    (6,792)
      Total other expense, net     (2,848)    (3,833)    (5,595)    (6,783)
Net loss                           $        $       $        $   
                                   (10,931)  (3,803)   (22,698)  (7,386)
Weighted average shares
outstanding -
                                   105,403    60,004     99,005     58,515
basic and diluted
Net loss per share - basic and     $      $      $      $    
diluted                            (0.10)    (0.06)    (0.23)    (0.13)

Summary Balance Sheet Data
(in thousands)
                                             December 31,   June 30,
                                             2012             2012
Cash, cash equivalents and marketable        $   109,845    $    89,650
securities
Property, plant and equipment, gross         $    87,698   $    86,287
Working capital                              $    63,979   $    17,171
Total assets                                 $   128,373    $   108,073
Long-term debt, net                          $    94,417   $    92,106
Stockholders' deficit                        $   (31,717)  $   (85,806)

CONTACT: Tricia Haugeto
         (303) 386-1193
         thaugeto@arraybiopharma.com

SOURCE Array BioPharma Inc.

Website: http://www.arraybiopharma.com
 
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