forward-looking statements - jefferies group · 2016; data from both trials expected 2017-2018...
TRANSCRIPT
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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 time-
consuming 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 forward-
looking statements, whether as a result of new information, future events or otherwise.
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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
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• ADCs harness the specificity of antibodies and the potency of cytotoxic agents
ADCs
TUMORCELL
ADCs Are An Integral Part of Cancer TherapyImproving patient outcomes with targeted therapies
Kinase Inhibitors
Target outside
of cell
Target signaling
pathways inside of cell
IMMUNECELL
Checkpoint
Inhibitors
CAR-T
Tumor
Vaccines
Activate immune cells
mAbs
• Combinations of these novel modalities are the future of treatment in oncology
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ADCs
TUMORCELL
Robust Product Pipeline
IMMUNECELL
SGEN is advancing multiple programs in clinical trials and
preclinical development for a broad array of hematologic
malignancies and solid tumors
• ADCETRIS
• SGN-CD33A
• SGN-CD19A
• SGN-LIV1A
• SGN-CD70A
• ASG-22ME
• ASG-15ME
• SEA-CD40
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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
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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 60+ 93% 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 60+ 93% 29%
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The ADCETRIS Opportunity
YTD
2014
ADCETRIS
approved in
U.S.
First full year
U.S. sales;
approved in
EU
Global sales
>$250M
Continued
global
expansion;
global sales
nearing
$400M
2011 2012 2013 2014 2015 2016 – 2018
Continued data generation in
HL, DLBCL and other CD30+ NHL
Phase 3
Frontline HL
ECHELON-1
~
Phase 3
Frontline
MTCL
ECHELON-2
Phase 3
CTCL
ALCANZAPhase 3
AETHERA
sBLA
ADCETRIS has the opportunity
to be the foundation of care for
CD30-positive malignancies
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AETHERA Demonstrates Strong PFS Improvement
• 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 Small number of events
o Most placebo patients received ADCETRIS after progression
• Supplemental BLA filed with Priority Review; PDUFA date August 18, 2015
• Manuscript published in The Lancet; March 2015
PFS per Independent Review PFS per Investigator
HR 0.57; p=0.001
2-year PFS rate 63%HR 0.50; p=0.001
2-year PFS rate 65%
ADCETRIS
Placebo
ADCETRIS
Placebo
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Additional ADCETRIS Phase 3 Trials
Trial
Number of
Patients
Primary
Endpoint
ALCANZARelapsed 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-1Frontline HL
(A+AVD vs. ABVD)
1,240 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 2017-2018
ECHELON-2Frontline MTCL
(A+CHP vs. CHOP)
450 PFS
Global trials being conducted under SPA agreements
with FDA and scientific advice from EMA
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Redefining Frontline HL and MTCL
• 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%
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%
3-year follow up data presented at ASH 2014
• Expected CR rate in MTCL:39-53% with CHOP
• Expected 5-year OS in MTCL: 12-49%
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
Frontline Advanced Hodgkin Lymphoma
Frontline Mature T-cell Lymphoma
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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)
ADCETRIS Opportunity in Diffuse Large B-cell Lymphoma (DLBCL)
Plan to initiate randomized phase 2
trial of Rituxan and bendamustine
+/- ADCETRIS for R/R CD30+
DLBCL later in 2015
Frontline DLBCLRelapsed / Refractory 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
Cohort opened to evaluate
ADCETRIS plus RCHP in CD30
positive frontline DLBCL patients
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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
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Diverse Clinical-Stage PipelineSix 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 Relapsed breast cancer
SGN-CD70A Relapsed NHL, renal cell carcinoma
ASG-22ME Relapsed solid tumors
ASG-15ME Relapsed bladder cancer
SEA-CD40 Relapsed solid tumors
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Promising Early Data with SGN-CD33A inAcute 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
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Acute Myeloid Leukemia Treatment Paradigm
Younger, Fit Unfit / Decline
Intensive Therapy
Frontline High-dose chemotherapy (“7+3”)
followed by consolidation
Hypomethylating agents or
low-dose chemotherapy
Relapsed/
Refractory
7+3 failures or treatment to
re-induce remission to enable
allogeneic transplant
Treatment determined by
performance status; best supportive
care common
• 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
Phase 1b 7+3 combination;
single-agent maintenance,
consolidation
Phase 1 single-agent
and HMA combination
SGN-CD33A clinical trials
Phase 1 single-agentPhase 1 single-agent and
future trial opportunity
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SGN-CD19A is Active and Tolerable in R/R DLBCLNovel 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
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Additional Clinical-Stage Programs Advancing
*Being developed in collaboration with Agensys, an affiliate of Astellas
Program Target Status
SGN-LIV1A LIV-1 • Phase 1 trial in relapsed metastatic breast cancer
SGN-CD70APBD-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-CD40Immuno-oncology agent
CD40 • Phase 1 trial in relapsed solid tumors
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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
Anti-CD79b (RG7596, DCDS4501A) Non-Hodgkin lymphoma
Anti-NaPi2b (RG7599, DNIB0600A) Ovarian, non-small cell lung cancer
Anti-STEAP1 (RG7450, DSTP3086S) Prostate cancer
RG7882 Ovarian, pancreatic cancer
RG7841 Solid tumors
Anti-PSMA ADC Prostate cancer
Anti-GCC ADC Advanced gastrointestinal malignancies
Anti-EGFR ADC Glioblastoma
Undisclosed ADC Cancer
Affiliate of Astellas
Anti-ENPP3 ADC Renal cell carcinoma
Anti-CD37 ADC Cancer
Anti-5T4 ADC Solid tumors
Anti-C4.4a ADC Solid tumors
Anti-FGFR2 ADC Cancer
Anti-BCMA ADC Multiple myeloma, hematologic malignancies
Anti-TF ADC Solid tumors (Opt-in at end of phase 1)
Others Several additional collaborator programs
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Strong Financial Position
1Q15 total revenues $82.2 million
ADCETRIS net sales $48.9 million
Collaboration revenue $22.2 million
Royalty revenue $11.1 million
Cash & investments as of March 31, 2015 $296.0 million
Debt None
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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 Broaden clinical investigation in frontline and relapsed DLBCL
o Initiate combination trials with Opdivo (nivolumab) in HL and NHL
o Initiate exploratory trial in systemic lupus erythematosus
• Advance robust product pipeline
o Report emerging data on SGN-CD33A in AML and
discuss registration strategies
o Initiate phase 2 trial of SGN-CD19A in
second-line DLBCL
o Report data from pipeline programs
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