Forward-Looking Statements

Transcription

1

2 Forward-Looking Statements This presentation contains forward-looking statements, including statements related to Seattle Genetics corporate priorities, financial guidance and anticipated upcoming activities, potential regulatory approvals of ADCETRIS in additional indications, the initiation of future clinical trials and data availability from ongoing clinical trials and the timing thereof, the therapeutic and commercial potential of ADCETRIS and Seattle Genetics product candidates, and other statements that refer to Seattle Genetics expectations and projections or other characterizations of future events or circumstances. The results or events predicted in these statements may differ materially from actual future results or events. Factors that may cause such differences include risks related to Seattle Genetics ability to effectively commercialize ADCETRIS and the uncertainty of future financial results, risks related to adverse or inconclusive clinical trial results and the uncertain and timeconsuming regulatory approval process, risks inherent in the research and development of pharmaceutical drugs and the failure by Seattle Genetics to secure and maintain collaborations. More information about these and other risks and uncertainties faced by Seattle Genetics is contained under the heading Risk Factors in the company s quarterly report on Form 10-Q for the quarter ended March 31, 2015 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forwardlooking statements, whether as a result of new information, future events or otherwise. 2

3 Corporate Priorities Building ADCETRIS into a Potential Major Global Brand Approved for two indications in >55 countries; multiple guidelines listings >30 ongoing clinical trials in broad array of CD30+ malignancies Four phase 3 trials (AETHERA, ALCANZA, ECHELON-1, ECHELON-2) Advancing Our Pipeline 7 clinical-stage programs, including 6 antibody-drug conjugates (ADCs) and 1 immuno-oncology agent Goal to advance ~2 new programs into clinical development per year Enhancing Our Leadership Position in ADCs >20 ADCs in clinical trials utilize SGEN technology Advancing ADC technology through innovative antibody engineering techniques, novel linkers and highly-potent drug chemotypes 3

4 ADCs Are An Integral Part of Cancer Therapy Improving patient outcomes with targeted therapies ADCs harness the specificity of antibodies and the potency of cytotoxic agents Target outside of cell ADCs Activate immune cells Checkpoint Inhibitors mabs TUMOR CELL Kinase Inhibitors IMMUNE CELL Tumor Vaccines CAR-T Target signaling pathways inside of cell Combinations of these novel modalities are the future of treatment in oncology 4

5 Robust Product Pipeline SGEN is advancing multiple programs in clinical trials and preclinical development for a broad array of hematologic malignancies and solid tumors ADCs ADCETRIS SGN-CD33A SGN-CD19A SGN-LIV1A SGN-CD70A ASG-22ME ASG-15ME TUMOR CELL IMMUNE CELL SEA-CD40 5

6 ADCETRIS (Brentuximab Vedotin) is an Expanding Global Brand ADC targeting CD30 Approved in >55 countries for relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (salcl) SGEN has commercial rights in U.S. and Canada Collaboration with Takeda for ROW Broad global development plan for potential additional indications in earlier lines of therapy and other CD30+ malignancies NCCN guidelines and compendia listings in CD30+ PTCL, CD30+ DLBCL, CTCL and HL post-asct maintenance 6

7 Broad Clinical Evidence of ADCETRIS Activity Therapy N Setting ORR CR Single-agent 102 Relapsed HL 75% 34% Single-agent 58 Relapsed ALCL 86% 59% Single-agent 48 Relapsed CTCL 73% 35% Single-agent 48 Relapsed CD30+ DLBCL 44% 17% Single-agent 34 Relapsed CD30+ PTCL 41% 24% Single-agent 27 Frontline HL % 70% A + AVD 26 Frontline HL 96% 96% A + CHP 26 Frontline CD30+ MTCL 100% 88% A + bendamustine 48 Second-line HL 96% 83% A + RCHOP 51 Frontline DLBCL 80% 67% A + dacarbazine 14 Frontline HL % 29% 7

8 The ADCETRIS Opportunity ADCETRIS has the opportunity to be the foundation of care for CD30-positive malignancies Phase 3 Frontline HL ECHELON-1 ADCETRIS approved in U.S. First full year U.S. sales; approved in EU Global sales >$250M Continued global expansion; global sales nearing $400M YTD 2014 Phase 3 AETHERA sbla Phase 3 CTCL ALCANZA ~ Phase 3 Frontline MTCL ECHELON Continued data generation in HL, DLBCL and other CD30+ NHL 8

9 AETHERA Demonstrates Strong PFS Improvement PFS per Independent Review HR 0.57; p= year PFS rate 63% PFS per Investigator HR 0.50; p= year PFS rate 65% ADCETRIS Placebo ADCETRIS Placebo Consolidation therapy generally well tolerated; overall safety profile consistent with current prescribing information Interim OS analysis did not show a significant difference between treatment arms o o Small number of events Most placebo patients received ADCETRIS after progression Supplemental BLA filed with Priority Review; PDUFA date August 18, 2015 Manuscript published in The Lancet; March

10 Additional ADCETRIS Phase 3 Trials Trial Number of Patients Primary Endpoint ALCANZA Relapsed CTCL (vs. physician choice methotrexate or bexarotene) 124 ORR lasting at least 4 months Two investigator-sponsored trials in relapsed CTCL reported ~70% response rates Expect to complete enrollment in 2015; data anticipated in 2016 ECHELON-1 Frontline HL (A+AVD vs. ABVD) ECHELON-2 Frontline MTCL (A+CHP vs. CHOP) 1,240 PFS 450 PFS Seeking to redefine frontline therapy by integrating ADCETRIS Expect to complete enrollment in ECHELON-1 in 2015 and in ECHELON-2 in 2016; data from both trials expected Global trials being conducted under SPA agreements with FDA and scientific advice from EMA 10

11 Redefining Frontline HL and MTCL Frontline Advanced Hodgkin Lymphoma Phase 1 A+AVD (N=26) Complete remission 96% Pulmonary toxicity (any event) 0% 3-year failure-free survival 92% 3-year overall survival 100% Expected CR rate in advanced HL: 70-80% with ABVD Expected rate of pulmonary toxicity with ABVD alone: up to 25% Expected 3-year FFS in advanced HL: ~75% 3-year follow up data presented at ASH 2014 Frontline Mature T-cell Lymphoma Phase 1 A+CHP (N=26) Complete remission 88% 2-year progression-free survival 54% 2-year overall survival 80% 2-year follow up data presented at ESMO 2014 Expected CR rate in MTCL: 39-53% with CHOP Expected 5-year OS in MTCL: 12-49% 11

12 ADCETRIS Opportunity in Diffuse Large B-cell Lymphoma (DLBCL) Relapsed / Refractory DLBCL Higher single-agent activity and longer median PFS in CD30+ patients CD30 positive: ORR 44%, median PFS 17 weeks (n=49) CD30 undetectable: ORR 31%, median PFS 6.3 weeks (n=42) Frontline DLBCL Encouraging activity of A+RCHOP in intermediate-high / high-risk patients ORR 80%, with 67% CRs (n=51) Higher CR rate and longer durability in CD30+ patients Plan to initiate randomized phase 2 trial of Rituxan and bendamustine +/- ADCETRIS for R/R CD30+ DLBCL later in 2015 Cohort opened to evaluate ADCETRIS plus RCHP in CD30 positive frontline DLBCL patients 12

13 Clinical Trial Collaboration to Combine ADCETRIS with Opdivo (PD-1 Checkpoint Inhibitor) Goal: continue to establish ADCETRIS as foundation of care in CD30+ malignancies, while also evaluating novel combinations that may improve clinical outcomes for patients Clinical trial collaboration with Bristol-Myers Squibb to evaluate combination of ADCETRIS and Opdivo (nivolumab) Two trials planned to begin in 2015 o Relapsed Hodgkin lymphoma o Relapsed CD30+ non-hodgkin lymphoma, including DLBCL 13

14 Diverse Clinical-Stage Pipeline Six ADCs and one immuno-oncology agent Preclinical Phase 1 Phase 2 Pivotal / Phase 3 SGN-CD33A Relapsed AML Frontline AML (single agent, combinations) SGN-CD19A Relapsed DLBCL (R-ICE +/- SGN-CD19A): Phase 2 planned Relapsed ALL, NHL SGN-LIV1A SGN-CD70A ASG-22ME ASG-15ME SEA-CD40 Relapsed breast cancer Relapsed NHL, renal cell carcinoma Relapsed solid tumors Relapsed bladder cancer Relapsed solid tumors 14

15 Promising Early Data with SGN-CD33A in Acute Myeloid Leukemia Post-Baseline Bone Marrow Blast Reduction Bone marrow blast clearance in 44% of evaluable patients treated across all dose levels, including 21% with CR/CRi 77% of patients treated at doses 40 mcg/kg or higher had 50% blast reduction 15

16 Acute Myeloid Leukemia Treatment Paradigm SGN-CD33A clinical trials Younger, Fit Frontline High-dose chemotherapy ( 7+3 ) followed by consolidation Phase 1b 7+3 combination; single-agent maintenance, consolidation Unfit / Decline Intensive Therapy Hypomethylating agents or low-dose chemotherapy Phase 1 single-agent and HMA combination Relapsed/ Refractory 7+3 failures or treatment to re-induce remission to enable allogeneic transplant Phase 1 single-agent and future trial opportunity Treatment determined by performance status; best supportive care common Phase 1 single-agent AML patient outcomes have not meaningfully changed in more than 30 years SGN-CD33A utilizes newest SGEN ADC technology (PBD dimer, EC-mAb) CD33 is expressed across AML regardless of subtype, cytogenetic abnormality or underlying mutational heterogeneity 16

17 SGN-CD19A is Active and Tolerable in R/R DLBCL Novel ADC Targeting CD19 Best % Change Per Patient in Index Lesions (doses 3 mg/kg) Marked single-agent activity across multiple dose levels: ORR 35%; CR rate 20% Combinations enabled by lack of significant hematologic toxicity or neuropathy Plan to initiate randomized phase 2 trial in relapsed DLBCL during 2015: R-ICE +/- SGN-CD19A Goal of planned combination trial is to increase CR rate prior to autologous transplant 17

18 Additional Clinical-Stage Programs Advancing Program Target Status SGN-LIV1A LIV-1 Phase 1 trial in relapsed metastatic breast cancer SGN-CD70A PBD-based ADC CD70 Phase 1 trial in relapsed NHL, metastatic renal cell carcinoma ASG-22ME* Nectin-4 Phase 1 trial in relapsed solid tumors, such as bladder, breast and lung cancers ASG-15ME* SLITRK6 Phase 1 trial in relapsed bladder cancer SEA-CD40 Immuno-oncology agent CD40 Phase 1 trial in relapsed solid tumors 18 *Being developed in collaboration with Agensys, an affiliate of Astellas

19 ADC Collaborations with Industry-Leading Companies >$300M generated to date with potential for ~$4.5B in future milestones plus royalties Collaborator Program Preclinical Phase 1 Phase 2 Pivotal/Phase 3 Glembatumumab vedotin (Anti-GPNMB) Breast cancer Melanoma Affiliate of Astellas Anti-CD79b (RG7596, DCDS4501A) Anti-NaPi2b (RG7599, DNIB0600A) Anti-STEAP1 (RG7450, DSTP3086S) RG7882 RG7841 Anti-PSMA ADC Anti-GCC ADC Anti-EGFR ADC Undisclosed ADC Anti-ENPP3 ADC Anti-CD37 ADC Anti-5T4 ADC Anti-C4.4a ADC Anti-FGFR2 ADC Anti-BCMA ADC Non-Hodgkin lymphoma Ovarian, non-small cell lung cancer Prostate cancer Ovarian, pancreatic cancer Solid tumors Prostate cancer Advanced gastrointestinal malignancies Glioblastoma Cancer Renal cell carcinoma Cancer Solid tumors Solid tumors Cancer Multiple myeloma, hematologic malignancies Anti-TF ADC Solid tumors (Opt-in at end of phase 1) Others 19 Several additional collaborator programs

20 Strong Financial Position 1Q15 total revenues ADCETRIS net sales Collaboration revenue Royalty revenue Cash & investments as of March 31, 2015 $82.2 million $48.9 million $22.2 million $11.1 million $296.0 million Debt None 20

21 Anticipated Upcoming Activities Continue expanding ADCETRIS into earlier lines of therapy and other CD30+ malignancies o Obtain approval decision for ADCETRIS in the AETHERA setting o Complete enrollment in ECHELON-1 and ALCANZA trials in 2015 and in ECHELON-2 in 2016 o o o Broaden clinical investigation in frontline and relapsed DLBCL Initiate combination trials with Opdivo (nivolumab) in HL and NHL Initiate exploratory trial in systemic lupus erythematosus Advance robust product pipeline o o o Report emerging data on SGN-CD33A in AML and discuss registration strategies Initiate phase 2 trial of SGN-CD19A in second-line DLBCL Report data from pipeline programs 21

22