Array BioPharma Second Quarter of F2018 Update FEBRUARY 6, 2018

Transcription

1 Array BioPharma Second Quarter of F2018 Update FEBRUARY 6, 2018

2 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 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.

3 ARRAY S TOP PRIORITY Maximize Success of Encorafenib & Binimetinib 3 SIGNIFICANT MILESTONES ACHIEVED NEAR-TERM COMMERCIAL / BRAF-MUTANT MELANOMA NDAs and MAAs for BRAFm melanoma under review with FDA/EMA Secondary endpoint: Overall Survival (OS) 33.6 months Phase 3 met primary endpoint: mpfs 14.9 months WITH IMPORTANT UPCOMING VALUE DRIVERS 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 well-tolerated 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 Merck-sponsored collaboration Binimetinib + pembrolizumab in patients with MSS CRC initiated in Dec 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 $88.5 million in past 12 reported months BEACON CRC co-funding: Pierre Fabre (40%), Ono Pharmaceuticals (milestone payments), Merck KGaA (Erbitux supply)

4 BINIMETINIB & ENCORAFENIB POSITIONED FOR GLOBAL SUCCESS Ono Pharmaceutical and Pierre Fabre Partnerships Create Strong Global Footprint 4 U.S. EUROPE JAPAN Other: Canada, Israel ROW South Korea Upfront Payment: Global Development Co-Funding: Remaining Milestones: $30 million $31.2 million 40% 12% $425 million $156 million* *At current exchange rates Royalties: Max. 35% above 100M combined annual sales Max. 25% above 10B combined annual sales

5 COLUMBUS MET PRIMARY ENDPOINT Secondary endpoint: ENCO/BINI demonstrate OS of 33.6 months

6 COLUMBUS PHASE 3 RESULTS 6 Safety / Tolerability of COMBO450 * COMBO450 demonstrated mos of 33.6 months compared to vemurafenib alone Primary endpoint: COMBO450 significantly improved PFS compared with vemurafenib alone * DOSE EXPOSURE * mos 33.6 months vs months, HR (0.61), [95% CI ], p<0.001 mpfs 14.9 months vs. 7.3 months, HR (0.54), [95% CI ], p<0.001 Median duration of exposure was ~51 weeks for patients receiving COMBO450, versus 31 weeks and 27 weeks for the encorafenib and vemurafenib monotherapy arms, respectively Median dose intensity for both encorafenib and binimetinib was ~100% for patients treated with the combination 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 of special interest, defined based on toxicities commonly associated with commercially available MEK+BRAFinhibitor treatments included: rash (23%) pyrexia (18%) retinal pigment epithelial detachment (13%) photosensitivity (5%) ENCO=encorafenib; BINI=binimetinib; CI=confidence interval; COMBO450=ENCO 450 mg QD + BINI 45 mg BID *Presented at 2016 SMR Congress

7 Months HISTORICAL OVERALL SURVIVAL BENCHMARKS IN BRAFm MELANOMA* BRAF+MEK TARGETED THERAPY 7 BRAF+MEK combination therapy Vemurafenib Dabrafenib 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. cobrim (NCT ) = vemurafenib+cobimetinib vs. vemurafenib+placebo; Lancet Oncol 2016; 17: COMBI-D (NCT ) = dabrafenib+trametinib vs. dabrafenib+placebo; Tafinlar and Mekinist prescribing information Revised 6/2017 COMBI-V (NCT ) = dabrafenib+trametinib vs. vemurafenib; Lancet 2015; 386:

8 Annual Melanoma Mortality* GLOBAL MELANOMA MARKET Population Estimates 8 Melanoma Mutational Subgroups Estimated Annual Incidence Advanced/Metastatic Melanoma Patients BRAF WT ~50% BRAFm ~50% COLUMBUS population 18,000 16,000 14,000 12,000 10,000 8,000 6,000 4,000 2,000 0 US EU Japan * Based on SEER and GLOBOCAN epidemiology reports

9 $ millions PROJECTED ANNUAL US REVENUE OF BRAF/MEK INHIBITORS IN MELANOMA NOW EXCEED $400M 9 US Quarterly Revenues Highlights $120 $100 $80 $60 $40 Cotellic/Zelboraf Mekinist/Tafinlar Total MEK/BRAF Projected BRAF/MEK 12 month rolling revenue of over $400M 21% YOY growth (Tafinlar + Mekinist BRAF NSCLC approved in June) Tafinlar + Mekinist at 87% sales share in most recent quarter $20 $0 Feb '15 May '15 Aug '15 Nov '15 Feb ' 16 May '16 Aug '16 Nov '16 Feb '17 May '17 Aug '17 Nov '17 Rolling 3-months ending Source: IQVIA NSP Sales Data

10 PROMISING BEACON CRC SAFETY LEAD-IN ACTIVITY Phase 3 BRAF-Mutant CRC Registration Trial Advancing

11 PHASE 3 BRAF-MUTANT COLORECTAL CANCER STUDY DESIGN Potential to Establish BRAF + MEK + EGFR Combination as New Standard of Care 11 Currently Enrolling SAFETY LEAD-IN COMPLETE Safety and tolerability will be assessed in patients receiving encorafenib, binimetinib 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 Encorafenib + Binimetinib + 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

12 MONTHS MONTHS OBSERVED CLINICAL ACTIVITY FROM BEACON CRC SAFETY LEAD IN, PHASE 2 AND CERTAIN SEPARATE HISTORICAL BENCHMARKS IN 2 ND LINE+ BRAFm mcrc encorafenib + cetuximab 6 n = 50 Phase 2 mos in 2 ND Line+ BRAFm mcrc* Cetuximab + irinotecan 7 n=50 Informed the initiation of Phase 3 BEACON CRC cetuximab + chemo 1 n = 24 cetuximab + chemo 2 n = 12 FOLFIRI 3 2 nd Line n = 23 FOLFIRI + panitumamab 3 2 nd Line n = 22 cetuximab + chemo 4 n = 22 cetuximab + irinotecan 5 n = De Roock et al., Lancet Oncol, Ulivi et al., J Transl Med Peeters et al., ASCO Saridaki et al., PLoS One Loupakis et al., Br J Cancer Tabernero et al., ASCO Kopetz et al., ASCO % Binimetinib, encorafenib + cetuximab 6 Safety Lead-In ORR in 2nd Line+ BRAFm mcrc* 22% Encorafenib + cetuximab 1 Phase 2 4% 8% 6% Cetuximab + irinotecan 5 Cetuximab + chemo 2 Irinotecan Binimetinib, encorafenib + cetuximab 6 Safety Lead-In mpfs in 2nd Line+ BRAFm mcrc* 4.2 Encorafenib + cetuximab 1 Phase Cetuximab + irinotecan 5 Cetuximab + chemo 2 FOLFIRI 4 2 nd Line Panitumumab + FOLFIRI 4 2 nd Line 1. Tabernero et al., ASCO De Roock et al., Lancet Oncol, Seymour et al., Lancet Oncol, 2013 (supplementary appendix) 4. Peeters et al., ASCO Kopetz et al., ASCO Van Cutsem et al, ASCO GI 2018 *Array has not conducted head-to-head studies comparing encorafenib against these products, and these data come from independent studies.

13 BEACON CRC SAFETY LEAD-IN 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 BEST OVERALL RESPONSE PATIENTS (N=29)* N (%) CR + PR 14 (48) CR 3 (10) PR 11 (38) SD 13 (45) PD 0 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 ) *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

14 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 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, months), with 7 of 29 patients (24%) still in follow-up and progression-free RECIST ORR Criteria mpfs was similar between patients who had 1 vs 2 previous regimens (median, 95% CI, 7.6 [ ] vs 8.1 [ ] months) * * * 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. 1 Van Cutsem et al, ASCO GI 2018

15 Patient BEACON CRC SAFETY LEAD-IN 1 Combination of ENCO+BINI+CETUX achieved 8 month mpfs in BRAF-mutant CRC in Updated SLI Results 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) Duration of Exposure (Months) mcrc=metastatic colorectal cancer; Van Cutsem et al, ASCO GI 2018 ENCO=encorafenib; BINI=binimetinib; CETUX=cetuximab

16 BEACON CRC SAFETY LEAD-IN 1 Combination was well-tolerated 16 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) Only 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 or in combination with standard chemotherapy for mcrc 2 Two patients discontinued treatment due to AEs with only 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 Erbitux (cetuximab injection, for intravenous infusion). Full Prescribing Information, Eli Lilly and Company, IN, 2016.

17 Annual CRC Mortality* GLOBAL COLORECTAL CANCER MARKET Population Estimates 17 CRC Mutational Subgroups Annual Colorectal Cancer Mortality 160, , , ,000 80,000 60,000 40,000 20,000 0 US EU Japan * Based on SEER and GLOBOCAN epidemiology reports

18 STRATEGIC IMMUNO-ONCOLOGY PARTNERSHIPS & PORTFOLIO

19 MEK + PD-1 / PD-L1 DEVELOPMENT STRATEGY Collaborations advancing with Bristol-Myers Squibb, Merck & Pfizer 19 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)

20 FINANCIALS

21 SECOND QUARTER OF FISCAL 2018 Financial Results 21 Three Months Ended December 31, September 30, Increase / December 31, Increase / (Decrease) 2016 (Decrease) Revenue Reimbursement revenue $ 22,395 $ 18,192 $ 4,203 $ 27,948 $ (5,553) Collaboration and other revenue 8,508 8, ,030 2,478 License and milestone revenue 11,315 3,546 7,769 10, Total revenue 42,218 29,746 12,472 44,523 (2,305) Operating expenses Cost of partnered programs 13,716 11,759 1,957 9,026 4,690 R&D for proprietary programs 42,613 41,445 1,168 46,469 (3,856) General and administrative 11,607 12,048 (441) 8,834 2,773 Total operating expenses 67,936 65,252 2,684 64,329 3,607 Loss from operations (25,718) (35,506) 9,788 (19,806) (5,912) Loss on extinguishment and conversion of Notes (6,457) (6,457) (6,457) Change in fair value of notes payable (300) 200 (500) (600) 300 Net interest expense (1,578) (2,688) 1,110 (2,895) 1,317 Net loss $ (34,053) $ (37,994) $ 3,941 $ (23,301) $ (10,752) Net loss per share - basic and diluted $ (0.17) $ (0.22) $ 0.05 $ (0.14) $ (0.03) December 31, 2017 September 30, 2017 December 31, 2016 Cash, cash equivalents and marketable securities $ 420,317 $ 464,336 $ 117,432

22 VALUE DRIVERS

23 ARRAY S TOP PRIORITY Maximize Success of Encorafenib & Binimetinib 23 SIGNIFICANT MILESTONES ACHIEVED NEAR-TERM COMMERCIAL / BRAF-MUTANT MELANOMA NDAs and MAAs for BRAFm melanoma under review with FDA/EMA Secondary endpoint: Overall Survival (OS) 33.6 months Phase 3 met primary endpoint: mpfs 14.9 months WITH IMPORTANT UPCOMING VALUE DRIVERS 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 well-tolerated 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 Merck-sponsored collaboration Binimetinib + pembrolizumab in patients with MSS CRC initiated in Dec 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 $88.5 million in past 12 reported months BEACON CRC co-funding: Pierre Fabre (40%), Ono Pharmaceuticals (milestone payments), Merck KGaA (Erbitux supply)

24 THANK YOU