Array BioPharma
2nd Quarter F2016 Results
February 2, 2016
Safe Harbor Statement
Forward-looking statements made in the course of this presentation
are made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. The audience is cautioned
that such forward looking statements involve risks and uncertainties,
including those described in our annual report filed on form 10-K for
the year ended June 30, 2015, and other filings of the Company with
the Securities and Exchange Commission, which may cause the
Company's actual results and experience to differ materially from
anticipated results and expectations expressed in these forwardlooking statements.
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Array’s Top Priority
3
Binimetinib & Encorafenib Development & Commercialization
SIGNIFICANT PROGRESS IN 2015
Regained rights to binimetinib and acquired global rights to encorafenib
along with $100 million+ payment from Novartis
Completed Pierre Fabre collaboration including $30 million upfront,
$425 million potential milestones and robust, tiered, double-digit
royalties
 Array retains exclusive rights in key markets including U.S. & Japan
 Pierre Fabre has exclusive rights in other geographies, including
Europe, Asia & Latin America
NRAS-mutant melanoma Phase 3 (NEMO) trial achieved
primary endpoint
Published clinical results for
 BRAF-mutant colorectal cancer Phase 1/2
 BRAF-mutant melanoma Phase 2 (LOGIC2)
 NRAS-mutant melanoma Phase 1/2 (CDK 4/6 combo)
SECOMBIT trial will address sequential use of MEK+RAF with PD1+CTLA4 in BRAF-mutant melanoma
…WITH IMPORTANT VALUE DRIVERS AHEAD IN 2016
Phase 3/NRAS-mutant melanoma
 Present full results
 File for regulatory approval
Phase 3 Part 1/BRAF-mutant melanoma
 Announce results
 Present full results
 File for regulatory approval
Phase 3/LGS ovarian cancer
 Complete enrollment
BRAF-mutant metastatic colorectal cancer
 Present update from Phase 2 expansion
 Initiate Phase 3 global registration trial
NEMO
Meets Primary Endpoint
NRAS-Mutant Melanoma
Binimetinib Phase 3 Study
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NEMO Meets Primary Endpoint
 NEMO is a pivotal Phase 3 trial comparing binimetinib to dacarbazine in patients
with NRAS-mutated melanoma
 20% of patients with metastatic melanoma have NRAS-mutations
 NRAS diagnostic being developed in collaboration with Qiagen
 NEMO study met its primary endpoint of improving progression free survival (PFS)
compared with dacarbazine treatment
 Hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001
 Median PFS on the binimetinib arm was 2.8 months versus 1.5 months on
dacarbazine arm
 Binimetinib appeared to be generally well-tolerated
 Adverse events reported were consistent with results from previous, earlier
phase binimetinib studies in NRAS-mutant melanoma patients
 No new safety signals were seen
 More data to be presented at medical conference in 2016 including
 PFS, overall survival (OS), overall response rate (ORR), safety
 Prespecified subgroup analyses including outcomes in patients who
received prior treatment with immunotherapy
Positive results from the NEMO
trial further demonstrate the
potential of binimetinib
to provide an important new
treatment option for patients
with advanced/unresectable
NRAS-mutant melanoma.
SECOMBIT
BRAF-Mutant Melanoma
New Trial – SECOMBIT/Sequential Combo
Immuno and Target Therapy Study
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One of the most comprehensive studies assessing sequencing strategies
for targeted and immunotherapies in BRAF-mutant melanoma
 Evaluate best sequencing approach with combination of target agents (encorafenib + binimetinib) and the combination of
immunomodulatory antibodies (ipilimumab + nivolumab) in patients with BRAF-mutant melanoma
 Multicenter, international cooperative group trial sponsored by: Clinical Research Technology and Fondazione Melanoma
Onlus; supported jointly by Bristol-Myers Squibb and Array (via Novartis)
Binimetinib + Encorafenib Progression
Patients with
BRAF-Mutant
Melanoma
n=230
Randomization
Ipilimumab + Nivolumab
Progression
Binimetinib + Encorafenib 2 Cycles
Primary Endpoint: Overall survival (OS)
Key Secondary Endpoint: Progression free survival (PFS)
Ipilimumab + Nivolumab
Binimetinib + Encorafenib
Ipilimumab + Nivolumab
Progression
Binimetinib + Encorafenib
Strategic Collaboration
with Pierre Fabre Oncology
Strategic Collaboration with Pierre Fabre Oncology
Selection Criteria & Summary of Deal Terms
Pierre Fabre is a Strong European
Commercial Partner
 Company with Europe as leading geographic priority with robust
emerging market capability to provide scale to collaboration
 Company with significant footprint in Oncology Development, Sales
& Marketing
 Company willing to commit significant resources to ensure
binimetinib and encorafenib success
 Company providing robust downstream economics (royalties) for
ready-to-file products
The agreement was reviewed and approved by the European Commission on
Competition in December 2015
Benefits to Array
 $30 million upfront
 40% funding for certain future clinical
development
 Up to $425 million in potential development and
commercialization milestones
 Robust, tiered double-digit royalties
Commercialization Rights
Array retains exclusive rights in:
 United States
 Canada
 Japan
 Korea
 Israel
Pierre Fabre will have exclusive rights in all other
geographies, including Europe, Asia and Latin
America
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Immuno-Oncology
Discovery Collaboration
New Immuno-Oncology Preclinical Collaboration
Enabling Novel Drug Target Prosecution in Immuno-Oncology
Multi-program immuno-oncology collaboration
Leveraging Array’s capabilities and track record in small molecule drug discovery
Small Molecule Opportunity

Many targets from multiple target classes
are implicated in the immunosuppressive
state of the tumor microenvironment. Many
targets are uniquely suited to small
molecule approaches and not modulation by
biotherapeutics

Small molecule target modulation is
underexplored in Immuno-Oncology

Collaborating with world-class scientific
advisory board (SAB) and leading academic
partners to pursue immuno-oncology
programs

SAB includes:
 Medicinal Chemistry and Structure Enabled Drug Design
 Pharmacology, Pharmaceutics and Pharmacokinetics
 Target identification through chemical biology
Leveraging Belfer’s immuno-oncology expertise and connectivity to Dana-Farber
Cancer Institute (DFCI) investigators, knowledge base and capabilities for
 Target identification and validation
 Novel preclinical models for immunotherapeutic drug assessment
 Tumor immune infiltrate profiling in clinical samples for mechanistic assessment and
patient selection
Array and DFCI scientists discovering innovative
immunotherapies
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Keith Flaherty (MGH)
Ben Cravatt (TSRI)
David McDermott (BIDMC)
Doug Lauffenburger (MIT)
Kwok- Kin Wong (DFCI/HMS)
Kris Vaddi (Ex-InCyte)
Jedd Wolchok (MSKCC)
Forest White (MIT/Koch)
Trevor Bivona (UCSF)
Peter Hammerman (DFCI/HMS)
Gregory Beatty (Upenn)
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ARRY-797
P38 Inhibitor for LMNA-Related Dilated
Cardiomyopathy (DCM)
LMNA-Related Dilated Cardiomyopathy (DCM)
LMNA-related DCM is a rare, degenerative
cardiovascular disease characterized by
13
U.S. Prevalence Estimate
 DCM diagnosis (ejection fraction <40%, dilated ventricle)
 Presence of mutations in lamin A/C gene
 Poor prognosis, ~70% of patients have death, major cardiac event or
transplant by age 45
 Events defined as cardio vascular (CV) death, heart transplant or major
cardiac event
LMNA-related DCM under-diagnosed due
to infrequent genetic testing
 Presence of LMNA mutation does not currently change
treatment practice

Early/mid-stage patients: ACE inhibitors, beta blockers and diuretics

Advanced patients: Pacemaker/defibrillator, heart transplant
Dilated Cardiomyopathy (DCM)
~250,000 patients
Idiopathic DCM
120-150,000 patients
LMNA-DCM
6-8,000 patients
Diagnosed
<1,000
Rationale for ARRY-797 in Treatment of LMNA-Related Dilated
DCM
Stress
 Mechanical stress-induced apoptosis has
been proposed as the mechanism
underpinning DCM in lamin A/C–deficient
hearts
Cytoplasm
RAC1
 ARRY-797 normalizes left ventricular
morphology and improves function in a
LMNAN195K model of DCM
 Physician-sponsored single-patient IND
indicated ARRY-797 treatment has been
associated with cardiac function
improvements and was well tolerated
CDC42
MLK1
 p38 MAPK signaling regulates myocyte
growth and survival in response to
mechanical stress and has been
implicated in cardiac dysfunction in
laminopathies
 ARRY-797 is a potent inhibitor of
p38 MAPK
Extracellular
MKK3, 6
p38 MAPK
ARRY-797:
p38 Inhibitor
LMNA
Genetic
Mutation
Stress
p38 MAPK
Nuclear Envelope
RNA binding
proteins
Transcription
factors
DNA Transcription/Translation
p53
ATF2
MEF2
MAPKAP-K2
and K3
Fax
Bax
Apoptotic/Survival Pathways and
Cardiomyocyte Remodeling Factors
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ARRY-797 Proof-of-Concept Trial
15
LMNA-Related Dilated Cardiomyopathy (DCM)
LMNA-Related
DCM Patients
n=12
ARRY-797
(Dose 1)
Crossover from lower to higher dose
allowed for inadequate response
ARRY-797
(Dose 2)
Primary Endpoints: Change from baseline in 6-minute walk test (12 weeks)
Secondary Endpoints
 Measures of left and right ventricular function
 Ejection fraction (Imaging study directly measures cardiac function); fractional area shortening
 Circulating biomarkers of cardiac function
 N-Terminal pro-Brain Derived Natriuretic Peptide: Blood test that indirectly measures cardiac wall stress and severity
and prognosis in cardiac failure
 Disease specific patient reported outcomes: Measures patient perception of improvement in functional status
 Others
Trial Sites: Brigham and Women’s Hospital/Harvard, Johns Hopkins University, Meriter Wisconsin Heart, University of
Colorado, Ohio State University, Stanford University
*6MWT: Integrated assessment of cardiac, respiratory, circulatory, and muscular capacity that has served as a basis for
regulatory approvals of a number of drugs across therapeutic areas including cardiovascular diseases
Compared with Historical Benchmarks, Encouraging Data
Emerging from Ongoing Phase 2 Trial
Product
Company
Indication
FDA
Approved
LMNA-DCM
No
PAH
Yes
ARRY-797
Array
Bosentan
Actelion
Idursulfase
Shire
MPS II
Yes
Riociguat
Bayer
CTEPH &
PAH
Yes
Elosulfase
Alfa
BioMarin
MPS IVA
Yes
Ambrisentan
Gilead
PAH
Yes
Laronidase
Genzyme
MPS I
Yes
6MWT: Mean Change vs. Baseline (Absolute Meters)
ARRY-797 absolute mean
improvement in 6MWT at 12
weeks is encouraging and
suggests a path forward when
benchmarked against drugs
approved based on 6MWT
0
10
20
30
40
50
Meters
ARRY-797 secondary endpoint measures also suggest encouraging activity (NT-proBNP, patient
reported outcomes)
Patient experience out to 48 weeks continues to be encouraging
16
Financials & Value Drivers
Second Quarter of Fiscal 2016
18
Financial Results
Three Months Ended
September 30,
2015
Three Months Ended
December 31,
2015
2014
Revenue
Reimbursement revenue
$
Collaboration and other revenue
License and milestone revenue
Total revenue
Operating expenses
Cost of partnered programs
R&D for proprietary programs
General and administrative
Total operating expenses
Loss from operations
Net interest expense
27,348
$
—
$
9,623
6,977
1,105
35,430
6,820
20,099
26,919
6,574
—
16,197
5,663
41,351
9,938
56,952
13,098
11,817
8,078
32,993
6,212
20,998
7,358
34,568
(21,522)
(6,074)
(18,371)
(2,642)
(2,537)
(2,616)
Net loss
$
(24,164)
$
(8,611)
$
(20,987)
Net loss per share - basic and
diluted
$
(0.17)
$
(0.06)
$
(0.15)
Cash, cash equivalents, marketable
securities and accounts receivable
December 31,
2015
September 30,
2015
$
$
185,371
173,320
June 30, 2015
$
185,129
Array Product Portfolio
19
2016 Value Drivers
Indication(s)
BRAF Melanoma
(COLUMBUS)
Status
1H 2016
2H 2016
COLUMBUS Part 1 Results
Phase 3
Regulatory Submission
(binimetinib+encorafenib)
Binimetinib &
Encorafenib
NRAS Melanoma
(NEMO)
Regulatory Submission
Phase 3
(binimetinib)
LGS Ovarian
(MILO)
Phase 3
NEMO Publication
Complete Enrollment
(binimetinib)
BRAF Colorectal Cancer (CRC)
(Encorafenib+other agent(s)
NSCLC
(SELECT-1)
Selumetinib
Thyroid Cancer
(ASTRA)
NF1
ARRY-797
LMNA-related DCM
Phase 2 BRAF CRC
Update
Phase 2/3
Phase 3 global registration trial (start date TBA)
Phase 3
SELECT-1 Top-Line Results
Enrollment Ongoing
Registration
trial
Enrollment Ongoing
Phase 2
Trial Ongoing
MILO: MEK Inhibitor in Low Grade Serous Ovarian Cancer; NEMO: NRAS melanoma and MEK inhibitor; COLUMBUS: Combination of LGX818 used with MEK162 in BRAF mutant unresectable skin cancer; ASTRA: Pivotal trial in differentiated thyroid cancer; SELECT-1: selumetinib +
docetaxel in patients with KRAS NCSLC
Thank You
arraybiopharma.com