R&D Day for Investors and Analysts
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R&D Day for Investors and Analysts November 16, 2020 Seagen 2020 R&D Day Clay Siegall, Ph.D. Roger Dansey, M.D. Nancy Whiting, Pharm.D Megan O’Meara, M.D. Shyra Gardai, Ph.D. President & Chief Chief Medical Officer EVP, Corporate Strategy VP, Early Stage Executive Director, Executive Officer Alliances and Development Immunology Communications 2 Forward-Looking Statements Certain of the statements made in this presentation are forward looking, such as those, among others, relating to the Company’s potential to achieve the noted development and regulatory milestones in 2021 and in future periods; anticipated activities related to the Company’s planned and ongoing clinical trials; the potential for the Company’s clinical trials to support further development, regulatory submissions and potential marketing approvals in the U.S. and other countries; the opportunities for, and the therapeutic and commercial potential of ADCETRIS, PADCEV, TUKYSA, tisotumab vedotin and ladiratuzumab vedotin and the Company’s other product candidates and those of its licensees and collaborators; the potential to submit a BLA for accelerated approval of tisotumab vedotin; the potential for data from the EV-301 and EV-201 cohort 2 clinical trials to support additional regulatory approvals of PADCEV; the potential for the approval of TUKYSA by the EMA; the therapeutic potential of the Company’s SEA technology and of the Company’s early stage pipeline agents including SGN-B6A, SGN-STNV, SGN-CD228A, SEA-CD40, SEA-TGT, SEA-BCMA and SEA-CD70; as well as other statements that are not historical fact. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include without limitation: the risk that the Company or its collaborators may be delayed or unsuccessful in planned clinical trial initiations, enrollment in and conduct of clinical trials, obtaining data from clinical trials, planned regulatory submissions, and regulatory approvals in the U.S. and in other countries in each case for a variety of reasons including the difficulty and uncertainty of pharmaceutical product development, negative or disappointing clinical trial results, unexpected adverse events or regulatory actions and the inherent uncertainty associated with the regulatory approval process; risks relating to the Company’s collaboration agreements and its ability to achieve development and commercialization progress thereunder; and risks related to the duration and severity of the COVID-19 pandemic and resulting global economic, financial and healthcare system disruptions. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. 3 CEO Strategic Overview Clay Siegall, Ph.D. President & Chief Executive Officer A Global Oncology Company Innovative research and Three approved therapies Our Mission the leader in ADCs fueling with multi-indication opportunities robust pipeline of targeted in blood cancers and solid tumors Discovering, developing, medicines for cancer and commercializing transformative cancer Expanding U.S. and ex-U.S. medicines to make a Proven, world-class drug footprint complements strategic development driving patient- partnerships to reach patients globally meaningful difference focused clinical programs in people’s lives 5 The Pace of Our Progress is Accelerating TUKYSA approved in 5 countries Positive topline results from two PADCEV trials Positive data from pivotal trial of tisotumab vedotin*** ADCETRIS global sales >$1B Global collaborations with Merck on ladiratuzumab vedotin and TUKYSA PADCEV approved by FDA** Robust pipeline of programs with first- and/or Initiated Positive results from operations best-in-class potential ADCETRIS FDA-approved TUKYSA® HER2CLIMB trial and expanded to 6 Expanding global footprint indications; global POLIVY® approved by FDA 1998 approvals in >70 countries* and EMA (Roche) BLENREP® approved by FDA and EMA (GSK) 6 *in collaboration with Takeda **in collaboration with Astellas ***in collaboration with Genmab Our Strategic Priorities Support Long-term Growth 1 2 3 4 Execute commercially Maximize the potential Advance our late-stage Conduct innovative R&D to of our three approved programs toward securing maintain a robust early-stage products approvals for new products pipeline of novel targeted therapies • ADCETRIS is the foundation of care • Broad clinical development of • Tisotumab vedotin could be our • Seven phase 1 programs, including for CD30+ lymphomas ADCETRIS, PADCEV and TUKYSA 4th approved drug ADCs and I-O agents to address important unmet needs • Strong PADCEV and TUKYSA U.S. • Collaborating with Merck accelerates • Goal to submit 3-4 INDs per year launches and expands ladiratuzumab vedotin • Trials designed to inform early development • Preparing to launch TUKYSA ex-U.S. go/no-go decisions 7 Seagen is Advancing Multiple Targeted Therapies for Cancer ADCs harness the specificity of Targeting the Antibody-Drug monoclonal antibodies and the outside of the cell: Conjugates (ADCs) potency of cytotoxic agents Potential to improve • Sugar-engineered patient outcomes with antibodies (SEA) targeted therapies Targeting signaling Activating pathways inside immune cells: the cell: CANCER CELL • Sugar-engineered IMMUNE CELL antibodies (SEA) • Small molecule TKIs Various combinations of these novel modalities are likely to be the future of treatment in oncology Our Clinical Pipeline is Broadly Investigating Solid Tumors and Hematologic Malignancies Approved indication Study planned / underway Bladder Breast Lung Head and Neck CRC Melanoma Pancreatic Cervical Ovarian Uterine GEC Prostate Mesothelioma cSCC Endometrial Biliary Tract HL ALCL CTCL PTCL DLBCL MM AML/MDS ADCETRIS • • • • Technology Approved PADCEV • Vedotin ADC TUKYSA • 8-load MMAE ADC TV Late Stage Sugar-engineered LV antibody (SEA) SEA-BCMA Small Molecule TKI SGN-CD228A SEA-CD40 Early Stage SEA-TGT SGN-B6A SEA-CD70 SGN-STNV* *IND submitted November 2020 9 Sandy ® Treated for urothelial cancer PADCEV (enfortumab vedotin) with PADCEV. Antibody-Drug Conjugate (ADC) Targeting Nectin-4 Roger Dansey, M.D. Chief Medical Officer In collaboration with Nectin-4 is Expressed Across the Spectrum of Urothelial Cancer Locally Advanced / Non-muscle Invasive Bladder Cancer Muscle Invasive Bladder Cancer Metastatic UC (NMIBC) (MIBC) (la/mUC) Typically treated with TURBT and BCG* Typically treated with cystectomy +/- platinum Limited treatment options Bladder lumen Lamina propria Inner muscle Outer muscle Tis Ta T1 T2a T2b T3 T4 Carcinoma Non-invasive Tumor invades Tumor invades Tumor invades Tumor invades Tumor invades In situ papillary connective tissue Superficial muscle deep muscle perivesical tissue adjacent tissue carcinoma and organs *TURBT: Transurethral Resection of Bladder Tumor Adapted from Springer Nature: Knowles MA and Hurst CD. Nature Rev Cancer. 2015;15(1):25-41 BCG: Bacillus of Calmette and Guerin vaccine 11 Broad PADCEV Development Program in Urothelial Cancer MONOTHERAPY COMBINATION w/ KEYTRUDA® (PEMBROLIZUMAB) MONOTHERAPY FDA-approved Expand FDA Expand into mUC Pursue first-line mUC Advance into Explore indication indication globally muscle-invasive non-muscle bladder cancer invasive disease Accelerated Global trial ✓ approval pathway EV-201 Cohort 1 EV-201 Cohort 2 EV-301: randomized EV-103 Cohort K: EV:302: randomized KEYNOTE 905/ Non- muscle-invasive trial randomized to to PADCEV plus EV-303 and another bladder cancer mUC following mUC post-PD1 PADCEV +/- KEYTRUDA vs planned trial platinum and PD(L)-1 mUC post-platinum Clinical trial plans in KEYTRUDA chemotherapy and PD(L)-1 Two randomized trials development for Cis-ineligible patients in cis-ineligible and BCG-unresponsive Cis-eligible and cis-eligible patients ineligible patients PADCEV administration into the bladder feasible based on preclinical data mUC: metastatic urothelial cancer 12 PADCEV Induces High Response Rates and Prolongs PFS and OS in Previously Treated mUC EV-201 cohort 2 and EV-301 supplemental BLA planned in 1Q21 EV-201 COHORT 2 (N~91) EV-301 (N~600) Hazard ratio 0.70 ORR 52% [95% CI: 40.8, 62.4] OS [95% CI: 0.56, 0.89] P=0.001 Hazard ratio 0.61 DOR 10.9 mos PFS [95% CI: 0.50, 0.75] P<0.00001 Tolerable with a manageable safety profile* PADCEV arm adverse events consistent with USPI* • Full data to be presented at an upcoming medical meeting • At a planned interim analysis, the IDMC recommended the study be stopped for efficacy EV-201 COHORT 1 (N=125) • Full data to be presented at an upcoming medical meeting ORR 44% [95% CI: 35.1, 53.2] DOR 7.6 mos Tolerable with a manageable safety profile* 13 *See important safety information on PADCEV.com Promising Data with PADCEV plus KEYTRUDA Support Registration Trials in First-line mUC Maximal Target Lesion Reduction by PD-L1 status Progression-Free and Objective Response Rate per Investigator Survival Median PFS: 12.3 months (95% CI: 7.98, -) Best Response 73% ORR • Confirmed CR/PR 12-month PFS rate: 50.1% 93% had tumor reduction (95% CI: 33.0, 65.0) N=45; 20 Events Overall Survival Median OS: not reached 12-month OS rate: 81.6% *Combined positive score high ≥10 (95%