Array BioPharma Third Quarter of F2018 Update MAY 9, 2018
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, 2017, 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.
MAXIMIZING SUCCESS OF ENCORAFENIB & BINIMETINIB IS ARRAY S TOP PRIORITY On Track for Commercialization 3 SIGNIFICANT MILESTONES ACHIEVED WITH IMPORTANT UPCOMING VALUE DRIVERS NEAR-TERM COMMERCIAL/BRAF-MUTANT MELANOMA * NDAs/MAAs/MMAs for BRAFm melanoma under review with FDA/EMA/PMDA ** Secondary endpoint: Median Overall Survival (mos) 33.6 months Phase 3 met primary endpoint: mpfs 14.9 months Global regulatory reviews FDA PDUFA June 30, 2018; FDA not currently planning to hold an ODAC PHASE 3/BRAF-MUTANT CRC Promising activity in safety lead-in reported at ASCO GI 2018 Triple combination of binimetinib, encorafenib and cetuximab was well-tolerated ǂ 8.0 months mpfs; 48% confirmed ORR, including 3 CRs I/O COLLABORATIONS/MSS CRC AND OTHER CANCERS BMS collaboration Binimetinib + nivolumab +/- ipilimumab in patients with RASm MSS CRC initiated in Sep. 2017 Merck-sponsored collaboration Binimetinib + pembrolizumab +/- FOLFOX or FOLFIRI in patients with MSS CRC initiated in Dec. 2017 Pfizer-sponsored collaboration Binimetinib + avelumab +/- talazoparib in patients with cancer Randomized portion of trial actively enrolling Trial active Trial active Trial to begin 3Q2018 COST SHARING Novartis reimbursement totaled $87 million in past 12 reported months BEACON CRC co-funding: Pierre Fabre (40%), Ono Pharmaceuticals (milestone payments), Merck KGaA (Erbitux supply) *COLUMBUS trial safety data available on slide 8; ** Pharmaceuticals and Medical Devices Agency, Japan; ǂ BEACON CRC trial safety data available on slide 17; RAS mutant
COLUMBUS FEATURED AT LEADING MEDICAL FORUMS & PUBLICATIONS 4 ORAL PRESENTATION Abstract Title: Overall Survival in COLUMBUS: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) vs Vemurafenib (VEM) or ENCO in BRAF-Mutant Melanoma (Abstract #223875) Presenter: Reinhardt Dummer, M.D. Date: June 4 INVESTOR WEBCAST Topic: COLUMBUS Overall Survival Presenter: Keith Flaherty, M.D. Date: June 4 Title: Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, openlabel, randomised phase 3 trial Lead Author: Reinhardt Dummer, M.D. Online Publication Date: March 21, 2018 Print Publication Date: May 2018 From The Lancet Oncology: Interpretation: Encorafenib plus binimetinib and encorafenib monotherapy showed favourable efficacy compared with vemurafenib. Overall, encorafenib plus binimetinib appears to have an improved tolerability profile compared with encorafenib or vemurafenib. Encorafenib plus binimetinib could represent a new treatment option for patients with BRAF-mutant melanoma.
COMMERCIAL READINESS ACTIVITIES WELL UNDERWAY IN ANTICIPATION OF LAUNCH PDUFA: June 30, 2018 5 Commercial Leadership & Infrastructure in Place Manufacturing Sales Force Medical Affairs MSLs Meeting with National and Regional KOLs Market Access Meeting with Payors, IDNs & GPOs Marketing Coming Soon Campaign
ENCORAFENIB & BINIMETINIB WELL-POSITIONED FOR SUCCESS Partnerships with Ono Pharmaceutical & Pierre Fabre Create a Strong Global Footprint 6 U.S. EUROPE JAPAN Other: Canada, Israel ROW South Korea Upfront & Milestone Payments: Global Development Co-Funding: Remaining Milestones: $30 million $35 million 40% 12% $415 million $159 million* Royalties: *Exchange rate as of the most recent quarter end Max. 35% above 100M combined annual sales Max. 25% above 10B combined annual sales
COLUMBUS MET PRIMARY ENDPOINT Secondary endpoint: ENCO/BINI demonstrate OS of 33.6 months
COLUMBUS PHASE 3 RESULTS 8 COMBO450 demonstrated mos of 33.6 months mos 33.6 months vs. 16.9 months, HR (0.61), [95% CI 0.47-0.79], p<0.001 * Primary endpoint: COMBO450 significantly improved PFS compared with vemurafenib alone ** mpfs 14.9 months vs. 7.3 months, HR (0.54), [95% CI 0.41-0.71], p<0.001 Safety / Tolerability of COMBO450 ** Generally well-tolerated & reported AEs were overall consistent with previous ENCO/BINI combination clinical trial results in BRAF-mutant melanoma patients Grade 3/4 AEs that occurred in more than 5% of patients receiving COMBO450 were increased GGT (9%), increased blood CK (7%) and hypertension (6%) The incidence of selected any grade of AEs based on toxicities commonly associated with commercially available MEK+BRAF-inhibitor treatments included: rash (22%) serous retinopathy (20%) pyrexia (18%) photosensitivity (5%) ENCO=encorafenib; BINI=binimetinib; CI=confidence interval; COMBO450=ENCO 450 mg QD + BINI 45 mg BID * Nominal p-value; ** Dummer et al, The Lancet Oncology 2018 ǂ COLUMBUS trial design is available as part of our online investor presentation: http://investor.arraybiopharma.com
Months HISTORICAL OVERALL SURVIVAL BENCHMARKS IN BRAFm MELANOMA* BRAF+MEK Targeted Therapy 9 Vemurafenib + cobimetinib Dabrafenib + trametinib 35 Vemurafenib 30 Dabrafenib 25 22.3 25.1 25.6 20 17.4 18.7 18 15 10 5 0 cobrim COMBI-D COMBI-V *Array has not conducted head-to-head studies comparing encorafenib and binimetinib against the other BRAF/MEK combination therapies, and these data come from separate Phase 3 studies. These trials were conducted under varying conditions and results may not be directly comparable. cobrim (NCT01689519) = vemurafenib+cobimetinib vs. vemurafenib+placebo; Lancet Oncol 2016; 17: 1248 60 COMBI-D (NCT01584648) = dabrafenib+trametinib vs. dabrafenib+placebo; Tafinlar and Mekinist prescribing information Revised 6/2017 COMBI-V (NCT01597908) = dabrafenib+trametinib vs. vemurafenib; Lancet 2015; 386: 444 51 Mekinist and Tafinlar are registered trademarks of Novartis Pharma AG
$ millions PROJECTED ANNUAL REVENUE OF TAFINLAR + MEKINIST TRENDING TO EXCEED $400M IN US & $1B GLOBALLY 10 $300 $250 $200 $150 $100 $50 $0 Quarterly Revenues Novartis Reported Financial Results: Net Sales Tafinlar /Mekinist 1Q15 2Q15 3Q15 4Q15 1Q16 2Q16 3Q16 4Q16 1Q17 2Q17 3Q17 4Q17 1Q18 US Global Quarterly Revenues Highlights Approx. 50% of advanced melanoma patients have activating BRAF mutations >29,000 individuals succumb to melanoma each year across the U.S., Europe & Japan Projected Tafinlar+Mekinist rolling annual revenue trending to exceed $400M in US and >$1B globally 21% YOY growth in the US & 34% globally (Tafinlar+Mekinist BRAFm NSCLC approved in April in EU & June in US) Tafinlar (dabrafenib) & Mekinist (trametinib) are registered trademarks of Novartis Pharma AG
PHASE 3 BRAF-MUTANT CRC REGISTRATION TRIAL ADVANCING Promising BEACON CRC Safety Lead-In Activity
PHASE 3 BRAF-MUTANT COLORECTAL CANCER STUDY DESIGN Potential to Establish MEK + BRAF + EGFR Combination as New Standard of Care 12 Currently Enrolling SAFETY LEAD-IN COMPLETE Safety and tolerability will be assessed in patients receiving binimetinib, encorafenib and cetuximab for the treatment of BRAF V600E-mutant metastatic colorectal cancer n=30 RANDOMIZED PORTION Patient population BRAF V600E mutant >65% 2 nd -line patients <35% 3 rd -line patients n=615 Randomization Triplet Therapy Binimetinib + Encorafenib + Cetuximab n=205 Doublet Therapy Encorafenib + Cetuximab n=205 Control Arm FOLFIRI + Cetuximab or irinotecan + Cetuximab n=205 DISEASE PROGRESSION DISEASE PROGRESSION DISEASE PROGRESSION Continued follow-up for evaluation of OS Primary Endpoint: Overall survival (OS) of the triplet therapy compared to the control arm Secondary Endpoints: Address efficacy of the doublet therapy compared to the control arm, and the triplet therapy compared to the doublet therapy Other Secondary Endpoints: Progression-free survival (PFS), objective response rate (ORR), duration of response, safety and tolerability. Health related quality of life data will also be assessed The trial will be conducted at over 250 investigational sites in North America, South America, Europe and the Asia Pacific region Patient enrollment is expected to be completed in 2018
MONTHS MONTHS OBSERVED CLINICAL ACTIVITY FROM BEACON CRC SAFETY LEAD IN AND CERTAIN SEPARATE HISTORICAL BENCHMARKS IN 2 ND LINE+ BRAFm mcrc 13 BRAF-containing triplet regimens mos in 2 ND Line+ BRAFm mcrc* 9.1 9.6 5.9 5.9 5.8 5.7 4.7 4.3 4.1 Dabrafenib, trametinib + panitumumab 1 n=91 Vemurafenib, cetuximab + irinotecan 2 n=49 Cetuximab + irinotecan 2 n=50 cetuximab + chemo 3 n = 24 cetuximab + chemo 4 n = 12 FOLFIRI 5 2 nd Line n = 23 FOLFIRI + panitumamab 5 2 nd Line n = 22 cetuximab + chemo 6 n = 22 cetuximab + irinotecan 7 n = 13 1. Corcoran et al., Cancer Discovery April 2018 2. Kopetz et al., ASCO 2017 3. De Roock et al., Lancet Oncol, 2010 4. Ulivi et al., J Transl Med. 2012 5. Peeters et al., ASCO 2014 6. Saridaki et al., PLoS One. 2013 7. Loupakis et al., Br J Cancer. 2009 48% ORR in BRAFm mcrc* Presented at 2018 ASCO-GI 8.0 mpfs in BRAFm mcrc* Presented at 2018 ASCO-GI 21% 16% 4% 8% 6% 4.2 4.3 2.0 1.8 1.8 2.5 Encorafenib, binimetinib + cetuximab 6 Safety Lead-In Dabrafenib, trametinib + panitumumab 1 Vemurafenib, cetuximab + irinotecan 2 Cetuximab + irinotecan 2 Cetuximab + chemo 3 Irinotecan 4 Encorafenib, binimetinib + cetuximab 6 Safety Lead-In Dabrafenib, trametinib + panitumumab 1 Vemurafenib, cetuximab + irinotecan 2 Cetuximab + irinotecan 2 Cetuximab + chemo 3 FOLFIRI 5 2 nd Line Panitumumab + FOLFIRI 5 2 nd Line 1. Corcoran et al., Cancer Discovery April 2018 2. Kopetz et al., ASCO 2017 3. De Roock et al., Lancet Oncol, 2010 4.Seymour et al., Lancet Oncol, 2013 (supplementary appendix) 5. Peeters et al., ASCO 2014 6.Van Cutsem et al, ASCO GI 2018 *Array has not conducted head-to-head studies comparing encorafenib and binimetinib against the other BRAF/MEK combination therapies, and these data come from separate Phase 3 and Phase 2 studies. These trials were conducted under varying conditions and results may not be directly comparable.
BEACON CRC SAFETY LEAD-IN 1 14 BEST OVERALL RESPONSE* PATIENTS (N=29)** N (%) CR + PR 14 (48) CR 3 (10) PR 11 (38) SD 13 (45) PD 0 8.0 months estimated mpfs at the time of analysis 48% confirmed ORR (CR + PR) in patients with BRAF V600E mcrc 3 Complete Responses 62% confirmed ORR in the patients (10/16) who received only 1 prior line of therapy DCR 27 (93) No postbaseline tumor assessments 2 (7) A BRAF V600E mutation was identified in 29 patients; 1 treated patient was determined to have a non-v600 BRAF mutation (BRAF G466V ) *Locally assessed response per RECIST 1.1; **Patients with BRAF V600E mutations; Nonresponders per intent-to-treat analysis; CR=complete response; PD=progressive disease; PR=partial response; SD=stable disease; 1 Van Cutsem et al, ASCO GI 2018
Best % Change from Baseline BEACON CRC SAFETY LEAD-IN 1 Out of 28 patients with both BRAF V600E -mutant mcrc and a post-baseline assessment, 27 showed tumor regression 15 100 80 60 40 20 0 20 1 Previous Regimen (n=15) 2 Previous Regimens (n=13) Of the 28 patients with a BRAF V600E mutation and a postbaseline tumor assessment, tumor regressions were observed in all but 1 patient Preliminary estimate of mpfs is 8.0 months (95% CI, 5.6 8.5 months), with 7 of 29 patients (24%) still in follow-up and progression-free. 40 60 80 RECIST ORR Criteria mpfs was similar between patients who had 1 vs 2 previous regimens (median, 95% CI, 7.6 [4.0 8.3] vs 8.1 [4.1 10.8] months). 100 26 01 17 02 16 05 12 04 6 13 28 25 24 23 27 09 * 10 22 21 15 19 20 18 07 14 * 08 03 11 * Patients mcrc=metastatic colorectal cancer. Excludes 1 patient with BRAF V600E mutation who did not have a postbaseline measurement *Patients with lymph node disease in short axis dimensions consistent with RECIST version 1.1 defined complete response. Non-responders per intent-to-treat analysis 1 Van Cutsem et al, ASCO GI 2018
Patient BEACON CRC SAFETY LEAD-IN 1 Combination of ENCO+BINI+CETUX achieved 8 month mpfs in BRAF-mutant CRC in Updated SLI Results 16 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 1 Previous Regimen (n=16) 2 Previous Regimens (n=13) Still on Treatment First Confirmed Response The majority of responses were observed at first tumor assessment (6 weeks). Responses were ongoing in 6/14 responding patients (43%) at the time of the data cutoff. The other 15 patients all achieved stable disease as their best response, and among them, 9 patients (60%) had prolonged stable disease of 6 months (range, 7 12 months). 0 1 2 3 4 5 6 7 8 9 10 11 12 13 Duration of Exposure (Months) mcrc=metastatic colorectal cancer; Van Cutsem et al, ASCO GI 2018 ENCO=encorafenib; BINI=binimetinib; CETUX=cetuximab
BEACON CRC SAFETY LEAD-IN 1 17 Grade 3/4 AEs reported in at least 10% of patients were: Fatigue (4) Urinary tract infection (3) Increased aspartate aminotransferase (AST; 3) Increased blood creatine kinase (CK; 3) Grade 3/4 skin-related AE reported was rash (Grade 3) in 1 patient (3%) The rate of Grade 3/4 skin toxicities was lower than generally observed for cetuximab alone (16%) or in combination with standard chemotherapy (18%) for mcrc 2 Two patients discontinued treatment due to AEs with one of these considered related to treatment mcrc=metastatic colorectal cancer. Excludes 1 patient with BRAF V600E mutation who did not have a postbaseline measurement 1 Van Cutsem et al, ASCO GI 2018 2 Erbitux (cetuximab injection, for intravenous infusion). Full Prescribing Information, Eli Lilly and Company, IN, 2016.
Annual CRC Mortality* GLOBAL COLORECTAL CANCER MARKET Population Estimates 18 CRC Mutational Subgroups Annual Colorectal Cancer Mortality 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 US EU Japan * Based on 2018 SEER and 2012 GLOBOCAN epidemiology reports
STRATEGIC IMMUNO-ONCOLOGY PARTNERSHIPS & PORTFOLIO
MEK + PD-1 / PD-L1 DEVELOPMENT STRATEGY Collaborations advancing with Bristol-Myers Squibb, Merck & Pfizer 20 Based on growing body of preclinical & clinical evidence that MEK inhibition may enhance the activity of immunotherapies, Array structured 3 clinical trial collaborations investigating the safety and activity of binimetinib with leading checkpoint inhibitors Binimetinib Combo Studies I/O partner Nivolumab (PD-1) Pembrolizumab (PD-1) Avelumab (PD-L1) Initial Patient Population RASm MSS colorectal cancer MSS colorectal cancer Pancreatic cancer & NSCLC Line Therapy 2 nd or 3 rd line 1 st or 2 nd line n/a Trial Sponsor Array Merck Pfizer Triple Combination Option (+/-) Ipilimumab (CTLA-4) FOLFOX (Chemo) or FOLFIRI (Chemo) Talazoparib (PARP)
FINANCIALS
THIRD QUARTER OF FISCAL 2018 Financial Results 22 Three Months Ended March 31, December 31, Increase / March 31, Increase / 2018 2017 (Decrease) 2017 (Decrease) Revenue Reimbursement revenue $ 24,751 $ 22,395 $ 2,356 $ 26,085 $ (1,334) Collaboration and other revenue 10,113 8,508 1,605 5,530 4,583 License and milestone revenue 31,503 11,315 20,188 1,665 29,838 Total revenue 66,367 42,218 24,149 33,280 33,087 Operating expenses Cost of partnered programs 17,712 13,716 3,996 7,432 10,280 R&D for proprietary programs 53,636 42,613 11,023 46,069 7,567 General and administrative 16,773 11,607 5,166 11,714 5,059 Total operating expenses 88,121 67,936 20,185 65,215 22,906 Loss from operations (21,754) (25,718) 3,964 (31,935) 10,181 Loss on extinguishment and conversion of Notes (6,457) 6,457 Impairment loss related to cost method investment Realized gains on investments and other 69 69 785 (716) Change in fair value of notes payable (100) (300) 200 (1,300) 1,200 Net interest expense (1,066) (1,578) 512 (2,867) 1,801 Net loss $ (22,851) $ (34,053) $ 11,202 $ (35,317) $ 12,466 Net loss per share - basic and diluted $ (0.11) $ (0.17) $ 0.06 $ (0.21) $ 0.10 March 31, December 31, March 31, 2018 2017 2017 Cash, cash equivalents and marketable securities $ 439,518 $ 420,317 $ 207,392
VALUE DRIVERS
MAXIMIZING SUCCESS OF ENCORAFENIB & BINIMETINIB IS ARRAY S TOP PRIORITY On Track for Commercialization 24 SIGNIFICANT MILESTONES ACHIEVED WITH IMPORTANT UPCOMING VALUE DRIVERS NEAR-TERM COMMERCIAL/BRAF-MUTANT MELANOMA * NDAs/MAAs/MMAs for BRAFm melanoma under review with FDA/EMA/PMDA ** Secondary endpoint: Median Overall Survival (mos) 33.6 months Phase 3 met primary endpoint: mpfs 14.9 months Global regulatory reviews FDA PDUFA June 30, 2018; FDA not currently planning to hold an ODAC PHASE 3/BRAF-MUTANT CRC Promising activity in safety lead-in reported at ASCO GI 2018 Triple combination of binimetinib, encorafenib and cetuximab was well-tolerated ǂ 8.0 months mpfs; 48% confirmed ORR, including 3 CRs I/O COLLABORATIONS/MSS CRC AND OTHER CANCERS BMS collaboration Binimetinib + nivolumab +/- ipilimumab in patients with RASm MSS CRC initiated in Sep. 2017 Merck-sponsored collaboration Binimetinib + pembrolizumab +/- FOLFOX or FOLFIRI in patients with MSS CRC initiated in Dec. 2017 Pfizer-sponsored collaboration Binimetinib + avelumab +/- talazoparib in patients with cancer Randomized portion of trial actively enrolling Trial active Trial active Trial to begin 3Q2018 COST SHARING Novartis reimbursement totaled $87 million in past 12 reported months BEACON CRC co-funding: Pierre Fabre (40%), Ono Pharmaceuticals (milestone payments), Merck KGaA (Erbitux supply) *COLUMBUS trial safety data available on slide 8; ** Pharmaceuticals and Medical Devices Agency, Japan; ǂ BEACON CRC trial safety data available on slide 17; RAS mutant
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