Developing &
Commercializing
Targeted Small Molecule
Drugs in Cancer
Array BioPharma
3rd Quarter F2015 Results
May 4, 2015
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, 2014, 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 forward-looking statements.
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Path to Commercialization
Upcoming Catalysts for Binimetinib & Encorafenib
European Partner Selection Expected in 2015
Initial regulatory submissions are expected in 2016 for both products
1H 2015
2H 2015
1H 2016
2H 2016
COLUMBUS
Part 1
Top-Line
Results
MILO
Top-Line
Results
PROJECTED
REGULATORY
FILINGS
PHASE III
ENROLLMENT
AND RESULTS
PHASE I/II
DATA
AVAILABILITY
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NEMO LPFV
COLUMBUS
Part 1 LPFV
ASCO 2015
• Ph I/II BRAF
Melanoma
• Ph 1/II GIST
w/imatinib
NEMO
Top-Line
Results
• Ph I/II NRAS melanoma w/LEE011
• Ph I/II BRAF melanoma LOGIC-2
• Ph 1/II BRAF CRC w/cetuximab
Planned publications for
2016 TBD
Encorafenib & Binimetinib Status Update
Transactions closed on March 2, 2015
 35 active binimetinib and/or encorafenib clinical trials including three
Phase 3 trials, with regulatory filings planned in 2016
 Under the Novartis agreement, Array is provided:
– $85 million milestone plus reimbursement for certain transaction-related expenses
– Elimination of $21.6 million payment obligation
– Completion and/or substantial funding for all ongoing and several planned clinical trials
– Access to several Novartis pipeline agents for future combination trials
– Continued clinical and commercial supply and support for technology transfer
– Conducting and fully funding the BRAF and NRAS companion diagnositc program
 Array is in discussions to identify an appropriate partner for global
development & European commercialization
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Binimetinib Phase 3 Study: NEMO
On track for regulatory filing in 2016
✓ Enrollment
Complete
Arm A
Binimetinib
Patients with advanced
(Stage IIIC) unresectable
or metastatic (Stage IV)
NRAS-mutant melanoma
N = 393
45 mg BID
Randomization
2:1
Stratification
• Stage
• ECOG Performance status
• Prior immunotherapy
Primary endpoint: PFS
Key secondary endpoint: OS
Other secondary: ORR, TTR, DOR, DCR, QoL, safety
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NEMO: NRAS melanoma and MEK inhibitor
N = 262
Arm B
Dacarbazine
1000 mg/m2 3W
N = 131
Binimetinib Phase 3 Study: COLUMBUS
On track for regulatory filing in 2016
Patient Enrollment:
Patients with BRAF
V600E/V600K,
advanced,
unresectable or
metastatic melanoma
N ~ 900
Randomization
Stratification
• Stage
• Performance status
• Prior Immunotherapy
✓Complete
PART 1
(1:1:1 Randomization)
On-going
PART 2
(3:1 Randomization)
Arm A
Binimetinib +
Encorafenib (450mg)
Arm D
Binimetinib +
Encorafenib (300mg)
Arm B
Vemurafenib
Arm C
Encorafenib (300mg)
Primary endpoint: Part 1 PFS comparison of Arm A versus Arm B
Secondary endpoint: OS
Part 2 rationale: Demonstrates contribution of binimetinib to combination
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Arm C
Encorafenib (300mg)
Binimetinib Phase 3 Study: MILO
On track for top-line results in 2016
Enrollment
Ongoing
Arm A
Patients with Recurrent or
Persistent Low-grade Serous
Carcinomas of the Ovary,
Fallopian Tube or Primary
Peritoneum
Must have received prior
platinum-containing therapy,
but no more than 3 prior
chemotherapies; unlimited prior
hormonal therapy
Binimetinib
45 mg BID
N = 240
Randomization
2:1
Cross-over permitted
Stratification
• Platinum-Free Interval
• Prior Systemic Treatment
Physician’s Choice
of Approved Chemo
Arm B
(paclitaxel, topotecan or
liposomal doxorubicin)
N = 360
Primary endpoint: Progression Free Survival
Secondary endpoints: OS, ORR, DOR, DCR, Safety, QOL
Cross-over rationale: Provides all patients potential access to binimetinib &
supports recruitment
MILO: MEK Inhibitor in Low Grade Serous Ovarian Cancer
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N = 120
MEK & BRAF Opportunities
Ras/Raf/MEK/Erk pathway mutations implicated in multiple cancer indications
Mutation Prevalence
100000
50000
40000
3 Encorafenib
and/or
Binimetinib
Pivotal Trials
Underway in
Selected Cancer
Populations
Mutation
Other (NF1, SPRED,
SOS1)
GNAQ/GNA11
30000
BRAF
20000
NRAS
10000
KRAS
0
NSCLC
Thyroid
Ovarian Melanoma Ocular Colorectal Pancreatic
1
3
(322,000) (231,000) (43,000) (30,000) Melanoma (213,000) (65,000) 2
(11,000)
Indication (US Prevalence)
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Data Source: Sanger Institute COSMIC Database (Nov 6, 2012)
1 Mascaux C et al. Br J Cancer 2005;92:131–9
2 Eser S et al. Br J Cancer 2014;111:817-822
3 Majority of thyroid patients treated with surgery & radioactive iodine
Ph. 1 BRAF-mut. mCRC – Nov. 2014 EORTC-NCI-AACR
Promising Antitumor Activity & Acceptable Safety
Ph. 1 arm = 54 patients (current data)
Ph. 2 arm = 100 patients (enrolling)
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Ph. 1 BRAF-mut. mCRC – April 2015 AACR Annual Meeting
Phase 1, Dual Combination Arm (encorafenib + cetuximab)
31% of patients received
treatment benefit for more
than 1 year
Complete response (CR)
Partial response (PR)
Stable disease (SD)
Progressive disease (PD)
Unknown
Ongoing
0
4
8
12
16
20
24
28
32
36
40
44
48
52
56
Duration of exposure, weeks
Data cutoff date: February 1, 2015.
60
64
68
72
76
80
84
88
92
Selected Binimetinib & Encorafenib Exploratory
Trials
EST.
PATIENT
INDICATION
DRUG(S)
BRAF V600+ melanoma
Bini + Encor ± LEE011 (CDK 4/6)
179
Selected tumors
Bini and Encor as single agents
<100
BRAF V600+ melanoma
Bini + Encor plus third agent*
140
BRAF+ mCRC
Encor + Cetuximab ± BYL719
(PI3Kα)
150
BRAF+ mCRC
Encor + Cetux. + WNT974
<100
BRAF V600+ melanoma
Encor + LEE011 (CDK 4/6)
<100
BRAF V600+ tumors
Encorafenib single agent
<100
RAS or BRAF+ solid tumors
Binimetinib + BYL719 (PI3Kα)
<100
NRAS melanoma
Binimetinib + LEE011 (CDK 4/6)
<100
Mutant or wild-type RAS mCRC
Binimetinib + Panitumumab
<100
Uveal Melanoma
Binimetinib + Protein kin. C
<100
Solid tumors
Binimetinib + Ganitumab
<100
Ovarian cancer
Binimetinib + Paclitaxel
<100
Solid tumors
Bini + BKM120 (pan-PI3K)
<100
PHASE 1
PHASE 1B
PHASE 2
PHASE 3
LOGIC-2
Binimetinib + Encorafenib
Encorafenib
Binimetinib
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*Third agent: LEE011 (CDK 4/6 inhibitor), pan FGFR inhibitor, BKM120 (pan PI3K inhibitor) or
c-MET inhibitor Investigator-sponsored trials and clinical pharmacology studies not listed above
Selumetinib (AstraZeneca)
Phase 3 Studies Underway
KEY DEAL
TERMS
FIRST
INDICATION
ADDITIONAL
PHASE 3 TRIALS
Potential Royalty: Double-digits
Potential Milestones Remaining: $70M
Structure: AZ responsible for global development & commercialization
SUMIT / Uveal Melanoma
ENROLLING
with dacarbazine; PFS; n=128; 1:1 randomization vs.
dacarbazine plus placebo; projected regulatory filing 2015
SELECT-1 / KRAS-mutant NSCLC (20-25% of NSCLC)
ENROLLING
with docetaxel; PFS; n=634; 1:1 randomization vs.
docetaxel plus placebo; projected regulatory filing 2017
ASTRA / Thyroid Cancer
ENROLLING
with RAI; Complete remission rate; n=304,
1:1 randomized vs. placebo; projected regulatory filing 2017
CYTOTOXIC
COMBINABILITY
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Selumetinib combines successfully with docetaxel
& other chemo at MTD
Financials &
Catalysts
Financial Results – Q3 Fiscal 2015
Three Months Ended
Nine Months Ended
March 31,
March 31,
2015
2014
2015
2014
Revenue
License and milestone revenue
$
Collaboration and other revenue
99
$
4,287
$
20,367
$
23,639
6,502
3,486
19,222
12,428
6,601
7,773
39,589
36,067
Cost of partnered programs
12,140
10,756
37,415
34,524
R&D for proprietary programs
11,817
14,131
35,824
35,322
8,187
5,405
23,064
16,056
Total revenue
Operating expenses
General and administrative
Total operating expenses
Net gain on the Binimetinib and Encorafenib
Agreements
32,144
30,292
96,303
85,902
80,010
—
80,010
—
Income (loss) from operations
54,467
(22,519)
23,296
(49,835)
6,402
—
6,402
—
(2,562)
(2,413)
(7,595)
(7,185)
Realized gain on marketable securities
Net interest expense
14
Net income (loss)
$
58,307
$
(24,932)
$
22,103
$
(57,020)
Net earnings (loss) per share - diluted
$
0.37
$
(0.20)
$
0.16
$
(0.47)
Cash as of Quarter End
$
190,616
$
111,638
190,616
111,638
Guidance
Guidance Fiscal 2015
Current
Prior
$ 20,600
29,400
50,000
$ 20,600
24,400
45,000
Operating expenses
Cost of partnered programs
R&D for proprietary programs
General and administrative
Total operating expenses
46,000
52,000
30,000
128,000
49,000
52,000
22,000
123,000
47,000
52,000
21,000
120,000
Loss from operations
(78,000)
(78,000)
(77,000)
Revenue
License and milestone revenue
Collaboration and other revenue
Total revenue
Realized gain on marketable securities
Net gain on the termination and asset transfer agreement
Novartis
F2014
$
25,500
17,500
43,000
6,500
Interest & other
15
Actual
80,000
80,000
(10,000)
(10,102)
(9,600)
$ (86,600)
Net loss
$
(1,500)
$
(8,102)
Net loss per share
$
(0.01)
$
(0.06)
$
(0.69)
Array Expected Product Portfolio Value Drivers
DRUG
INDICATION(S)
STATUS
Binimetinib
(MEK162)
LGS Ovarian Cancer
Q2
Q3
Q4
✓NEMO enrolled
NRAS Melanoma
BINIMETINIB
Q1
PH 3
Phase 3 NEMO top-line results
Phase 3 MILO enrollment ongoing
BINIMETINIB &
ENCORAFENIB
Binimetinib
(MEK162)
Encorafenib
(LGX818)
BRAF Melanoma
PH 3
✓COLUMBUS
Part 1 enrolled
Phase 3 COLUMBUS - Part 2 enrolling
BRAF-mel. & GIST data / ASCO
NRAS, BRAF-mel. & CRC data
TATTON NSCLC data / ASCO
Phase 3 SUMIT top-line results*
NSCLC
SELUMETINIB
Selumetinib
(AZD6244)
Thyroid Cancer
PH 3
Phase 3 SUMIT projected regulatory filing*
(AstraZeneca)
NF-1 data later in 2015*
Uveal Melanoma
Phase 3 SELECT-1 and ASTRA enrollment ongoing
FILANESIB
Filanesib
(ARRY-520)
Multiple Myeloma
PH 2
Generating data from single-agent & Kyprolis-combo Phase 2 trials
ARRY-797
ARRY-797
LMNA-related DCM
PH 2
Additional results
*Based on projections from AstraZeneca
16 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
Inventing, Developing
& Commercializing
Targeted Small Molecule
Drugs in Cancer
www.arraybiopharma.com
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