BOULDER, Colo., May 4, 2015 /PRNewswire/ -- Array BioPharma
Inc. (NASDAQ: ARRY) today reported results for the third quarter of
its fiscal year ending June 30,
2015.
Ron Squarer, Chief Executive Officer of Array, noted, "With
the close of the Novartis-GSK transaction, Array now owns both
binimetinib and encorafenib, two innovative oncology products in
Phase 3, with plans for regulatory submissions for each product in
2016. These transformative transactions have accelerated our path
to commercialization and provide us with the opportunity to develop
two potentially broadly active products in a number of
indications."
Array ended the quarter with $191
million in cash, cash equivalents and marketable
securities. Revenue for the third quarter of fiscal 2015 was
$6.6 million, compared to
$7.8 million for the same period last
year. Cost of partnered programs for the third quarter of
fiscal 2015 was $12.1 million,
compared to $10.8 million for the
same period last year. Research and development expense was
$11.8 million, compared to
$14.1 million in the same prior year
period. Net income for the third quarter was $58.3 million, or $0.37 per share (diluted), compared to a net loss
of $24.9 million, or ($0.20) per share (diluted), for the same period
in fiscal 2014. As part of the Novartis transaction, Array
received an $85 million cash payment
and extinguished net liabilities of $21.6
million which resulted in an increase in working capital of
$106.6 million. The
extinguished liabilities will not impact ending cash, cash
equivalents and marketable securities balance as of March 31, 2015. Of this amount,
$6.6 million will be treated as
deferred revenue. Also during the
quarter, Array entered into a third party agreement
to complete the Novartis transactions for a net consideration
of $25 million.
For the nine months ended March 31,
2015, revenue was $39.6
million, compared to $36.1
million for the same period in fiscal 2014. Net income for
the nine months ended March 31, 2015,
was $22.1 million, or $0.16 per share (diluted), compared to a net loss
of $57.0 million, or ($0.47) per share (diluted), in the comparable
prior year period.
KEY PIPELINE UPDATES
Binimetinib (MEK162) and
Encorafenib (LGX818) – Array regained worldwide rights to MEK
inhibitor, binimetinib and acquired worldwide rights to BRAF
inhibitor, encorafenib; Two Phase 3 studies completed enrollment;
Encorafenib BRAF colorectal cancer data presented at AACR
In April 2015, the NEMO and
COLUMBUS (Part 1) Phase 3 studies completed patient
enrollment. With NEMO enrollment complete, Array reaffirms a
projected regulatory filing of binimetinib in NRAS melanoma during
the first half of 2016. In addition, Array expects to share
updated data from a combination trial with binimetinib and LEE011,
a CDK 4/6 inhibitor, in NRAS melanoma at a scientific conference
during the second half of 2015. Furthermore, with COLUMBUS
(Part 1) enrollment complete, Array reaffirms a projected
regulatory filing of binimetinib in combination with encorafenib in
BRAF melanoma in 2016. Patient enrollment continues in Part 2
of COLUMBUS. Array expects updated BRAF melanoma data from
the Phase 1 / 2 combination trial of binimetinib and encorafenib to
be presented at the 2015 American Society of Clinical Oncology
(ASCO) annual meeting and the Phase 2 combination trial (LOGIC-2)
of binimetinib, encorafenib and a third agent (LEE011, BKM120,
BFJ398 or INC280) will be submitted to a scientific conference
later this year. Also, Array expects data from a Phase 1 / 2
study of binimetinib in combination with imatinib in patients with
gastrointestinal stromal tumors at ASCO.
The MILO Phase 3 trial study design was modified to incorporate
a cross-over provision, allowing all patients on the trial to have
access to binimetinib. Array estimates the availability of
top-line data from MILO in 2016 and a projected regulatory filing
of binimetinib in low-grade serous ovarian cancer in
2017.
As Array announced on March 2,
2015, Novartis' global, exclusive license to binimetinib
terminated with all rights reverting to Array, and Array acquired
global rights to encorafenib. Array received an $85 million upfront payment from Novartis and
reimbursement for certain transaction-related expenses.
Novartis is providing transitional regulatory, clinical development
and manufacturing services and will assign or license to Array
patent and other intellectual property rights it owns to the extent
they relate to binimetinib and encorafenib. All clinical
trials involving binimetinib and encorafenib currently sponsored by
Novartis or Array, including three pivotal trials, COLUMBUS
(BRAF-mutant melanoma / NCT01909453), NEMO (NRAS-mutant melanoma /
NCT01763164), and MILO (low-grade serous ovarian cancer /
NCT01849874), continue to be conducted as currently contemplated
and are substantially funded by Novartis. Beyond the three
Phase 3 trials, there are 32 active binimetinib and/or encorafenib
trials.
Array continues to engage in discussions to identify an
appropriate partner for global development and European
commercialization of both binimetinib and encorafenib.
Updated results of a Phase 1b study presented at the 2015
American Association for Cancer Research (AACR) annual meeting
showed that encorafenib, a BRAF inhibitor, and cetuximab, an EGFR
inhibitor, demonstrated promising anti-tumor activity when
administered as dual therapy and in combination with alpelisib
(BYL719), a PI3K inhibitor, in patients with BRAF-mutant colorectal
cancer. BRAF-mutant colorectal cancer is a mutational subtype
of colorectal cancer with a particularly poor prognosis where
cetuximab is expected to provide little benefit. Reported
objective response rates were 23% for dual therapy and 32% for
triple therapy, with median progression-free survival of 3.7 months
and 4.3 months, respectively, and 31% of patients on the
encorafenib+cetuximab arm stayed on treatment for longer than 52
weeks. Both treatment regimens were generally well-tolerated, with
adverse events (AEs) in both treatment arms generally mild to
moderate in severity. The most common treatment-related AEs were
fatigue, nausea, vomiting and infusion-related reaction (dual
therapy) and nausea, diarrhea, rash, hyperglycemia, and vomiting
(triple therapy). The 100-patient Phase 2 portion of the
study is ongoing. There are over 200,000 colorectal cancer
patients in the U.S. and it is estimated that the BRAF mutation is
found in approximately 12% of this population.
Selumetinib (partnered with AstraZeneca) – SUMIT study
completed enrollment; Three Phase 3 trials advancing, including a
study in non-small cell lung cancer (NSCLC); clinical updates at
scientific conferences
Three Phase 3 trials continue to evaluate the Array-invented MEK
inhibitor, selumetinib, in patients with advanced
cancers: second-line KRAS-mutant advanced or metastatic NSCLC
(SELECT-1 / NCT01933932), differentiated thyroid cancer (ASTRA /
NCT01843062) and metastatic uveal melanoma
(SUMIT/NCT01974752). With SUMIT enrollment complete,
AstraZeneca has projected a regulatory filing in uveal melanoma in
2015 and plans to present top-line data from the study later this
year. AstraZeneca expects to present initial data from a
combination study (TATTON) of selumetinib with mutant selective
EGFR inhibitor, AZD9291, in EGFR positive non-small cell lung
cancer at ASCO. AstraZeneca also expects to present data from
a Phase 2 study of selumetinib in pediatric neurofibromatosis Type
1 (NF-1) this year and recently initiated a Phase 2 study in NF-1
adult patients.
Filanesib (ARRY-520) –Two Phase 2 studies continue to
enroll
Filanesib is a highly selective, targeted KSP inhibitor with a
mechanism of action distinct from currently-available myeloma
therapies, such as immunomodulatory drugs and proteasome
inhibitors. Two studies with filanesib continue to enroll
patients with relapsed / refractory multiple myeloma: a
randomized Phase 2 Kyprolis® (carfilzomib) combination study
(ARRAY-520-216, NCT01989325) and the AfFIRM trial (NCT02092922), a
global Phase 2 single agent study. Array plans to provide
additional results later this year. Data from these trials
will inform next steps.
ARRY-797 (ARRY-371797) – Phase 2 trial enrolling patients
with LMNA-related dilated cardiomyopathy (DCM)
Array is enrolling a 12-patient Phase 2 study (NCT02057341) to
evaluate the effectiveness and safety of ARRY-797 in patients with
LMNA-related DCM, a serious, genetic cardiovascular
disease. By age 45, approximately 70% of patients with
LMNA-related DCM experience cardiovascular death, transplant
or a major cardiac event. Currently, the trial has patient
experience up to 48 weeks and ARRY-797 has been
well-tolerated. Preliminary data at early time points
continue to be encouraging for multiple endpoints across patients,
but further data is needed to fully assess the magnitude,
consistency and durability of effects. Array plans to provide
additional results later this year.
CONFERENCE CALL INFORMATION
Array will hold a
conference call on Monday, May 4,
2015 at 9:00 a.m. Eastern Time
to discuss these results. Ron Squarer, Chief Executive
Officer, will lead the call.
Conference Call Information
Date:
|
Monday, May 4,
2015
|
Time:
|
9:00 a.m. Eastern
Time
|
Toll-Free:
|
(844)
464-3927
|
Toll:
|
(765)
507-2598
|
Pass
Code:
|
5249676
|
Webcast, including Replay and Conference Call
Slides:
http://edge.media-server.com/m/p/8tsxszuw/lan/en
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. Six
Phase 3 studies are currently enrolling patients. These programs
include three cancer drugs, binimetinib (MEK162 / wholly-owned),
encorafenib (LGX818 / wholly-owned) and selumetinib
(AstraZeneca). 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 Array, 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 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 May 4, 2015. 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.
|
Statements of
Operations
|
(Unaudited)
|
(In thousands, except
per share amounts)
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
March
31,
|
|
March
31,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenue
|
|
|
|
|
|
|
|
License and milestone
revenue
|
$
|
99
|
|
|
$
|
4,287
|
|
|
$
|
20,367
|
|
|
$
|
23,639
|
|
Collaboration and
other revenue
|
6,502
|
|
|
3,486
|
|
|
19,222
|
|
|
12,428
|
|
Total
revenue
|
6,601
|
|
|
7,773
|
|
|
39,589
|
|
|
36,067
|
|
|
|
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
|
|
|
Cost of partnered
programs
|
12,140
|
|
|
10,756
|
|
|
37,415
|
|
|
34,524
|
|
Research and
development for proprietary programs
|
11,817
|
|
|
14,131
|
|
|
35,824
|
|
|
35,322
|
|
General and
administrative
|
8,187
|
|
|
5,405
|
|
|
23,064
|
|
|
16,056
|
|
Total operating
expenses
|
32,144
|
|
|
30,292
|
|
|
96,303
|
|
|
85,902
|
|
Net gain on the
Binimetinib and Encorafenib Agreements
|
80,010
|
|
|
—
|
|
|
80,010
|
|
|
—
|
|
Income (loss) from
operations
|
54,467
|
|
|
(22,519)
|
|
|
23,296
|
|
|
(49,835)
|
|
|
|
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
|
|
|
Realized gain from
marketable securities, net
|
6,402
|
|
|
—
|
|
|
6,402
|
|
|
—
|
|
Interest
income
|
15
|
|
|
22
|
|
|
36
|
|
|
61
|
|
Interest
expense
|
(2,577)
|
|
|
(2,435)
|
|
|
(7,631)
|
|
|
(7,246)
|
|
Total other income
(expense), net
|
3,840
|
|
|
(2,413)
|
|
|
(1,193)
|
|
|
(7,185)
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$
|
58,307
|
|
|
$
|
(24,932)
|
|
|
$
|
22,103
|
|
|
$
|
(57,020)
|
|
|
|
|
|
|
|
|
|
Net earnings
(loss) per share – basic
|
$
|
0.42
|
|
|
$
|
(0.20)
|
|
|
$
|
0.16
|
|
|
$
|
(0.47)
|
|
Net earnings
(loss) per share – diluted
|
$
|
0.37
|
|
|
$
|
(0.20)
|
|
|
$
|
0.16
|
|
|
$
|
(0.47)
|
|
|
|
|
|
|
|
|
|
Weighted average
shares outstanding – basic
|
139,769
|
|
|
125,471
|
|
|
135,113
|
|
|
122,277
|
|
Weighted average
shares outstanding – diluted
|
166,265
|
|
|
125,471
|
|
|
138,573
|
|
|
122,277
|
|
|
|
Summary Balance
Sheet Data
|
(unaudited)
|
(In
thousands)
|
|
|
|
March 31,
2015
|
|
June 30,
2014
|
|
|
|
|
|
Cash, cash
equivalents and marketable securities
|
|
$
|
190,616
|
|
|
$
|
111,638
|
|
Property, plant and
equipment, gross
|
|
92,259
|
|
|
90,447
|
|
Working
capital
|
|
151,678
|
|
|
68,943
|
|
Total
assets
|
|
208,445
|
|
|
139,053
|
|
Long-term debt,
net
|
|
107,985
|
|
|
103,952
|
|
Total stockholders'
equity (deficit)
|
|
50,151
|
|
|
(25,721)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACT:
|
Tricia
Haugeto
|
|
(303)
386-1193
|
|
thaugeto@arraybiopharma.com
|
Logo -
http://photos.prnewswire.com/prnh/20121029/LA02195LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/array-biopharma-reports-financial-results-for-the-third-quarter-of-fiscal-2015-300076506.html
SOURCE Array BioPharma