Credit Suisse 27 th Annual Healthcare Conference

Transcription

1 CHANGING THE COURSE OF HUMAN HEALTH THROUGH BOLD PURSUITS IN SCIENCE Credit Suisse 27 th Annual Healthcare Conference November 14, 2018

2 Forward-Looking Statements and Adjusted Financial Information This presentation contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words expects, anticipates, believes, intends, estimates, plans, will, outlook, targets and similar expressions. Forward-looking statements are based on management s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission. In addition to unaudited financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted financial measures. Further information relevant to the interpretation of adjusted financial measures, and reconciliations of these adjusted financial measures to the most comparable GAAP measures, may be found in the Appendix and on our website at in the Investor Relations section. 2

3 Our Mission and Vision Celgene is building a preeminent global biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for patients with cancer, immune-inflammatory, and other unmet medical needs 3

4 Deploying a Strategy to Grow Through 2020 and Beyond Execute Delivering on 2020 Accelerate Positioning to Grow Beyond 2020 Expand Creating Sustainable Growth 4

5 Accelerating Diversification by Advancing Medicines to Transform the Treatment of Diseases Multiple Myeloma 60K Incidence $27B HEMATOLOGY & ONCOLOGY Non-Hodgkin Lymphoma 90K Incidence $17B Myeloid Diseases 65K Incidence $5B Psoriasis / Psoriatic Arthritis 5M $26B INFLAMMATION & IMMUNOLOGY Multiple Sclerosis 650K $23B Inflammatory Bowel Disease 2.3M $21B Source: Market size projections are for 2022 from Evaluate Pharma, December 2017 and Decision Resources Disease Landscape and Forecast; Epidemiology is for 2018 from Decision Resources Disease Landscape and Forecast, Kantar Health CancerMPact database and Putnam Associates 5

6 Accelerating Diversification by Advancing Medicines to Transform the Treatment of Diseases Multiple Myeloma 60K Incidence $27B HEMATOLOGY & ONCOLOGY Non-Hodgkin Lymphoma 90K Incidence $17B Myeloid Diseases 65K Incidence $5B Psoriasis / Psoriatic Arthritis 5M $26B INFLAMMATION & IMMUNOLOGY Multiple Sclerosis 650K $23B Inflammatory Bowel Disease 2.3M $21B Source: Market size projections are for 2022 from Evaluate Pharma, December 2017 and Decision Resources Disease Landscape and Forecast; Epidemiology is for 2018 from Decision Resources Disease Landscape and Forecast, Kantar Health CancerMPact database and Putnam Associates 6

7 OTEZLA Is Positioned for Continued Strong Growth Psoriasis / Psoriatic Arthritis 5M $26B Competitive Positioning in the US Psoriasis Market #1 New to Brand Share: #2 Total Branded Rx Share: #1 Pre-biologic Rx Share: 36% 21% 23% Biologic Step-free Access: 80% Significant Untapped Opportunity ~10 Million diagnosed psoriasis patients in core markets Approximately 60% of diagnosed psoriasis patients remain untreated Expansion Opportunities Building for Sustained OTEZLA Growth Submitted Behçet's disease snda in the U.S. Positive Ph III data for STYLE in scalp psoriasis Initiating the Ph III ADVANCE trial with OTEZLA in mild-tomoderate plaque psoriasis Ongoing investment in brand awareness and positioning, including expansion of the posttopical market opportunity Source: Based on SHS Claims data through Jun 18, Un projected Claims including Bridge and PAP, data subjected to restate Total Branded Rx Share based on SHS Prescriber data through Aug 18, data subjected to restate Decision Resources. Psoriasis Disease Landscape and Forecast, updated May

8 Ozanimod Advancing Potentially Differentiated Profile in Relapsing MS Ozanimod A Potentially Differentiated Oral in MS Multiple Sclerosis 650K $23B U.S. NDA and EU MAA submissions planned for Q1:19 Following the Type A meeting with FDA, submission plan includes bridging non-clinical studies and using existing PK/PD data Additional human clinical efficacy and safety studies not needed Competitive Profile Based on Two Large Phase III Trials Efficacy across clinical and MRI endpoints Favorable safety profile no significant cardiotoxicity or infection risk Favorable tolerability profile low incidence of gastrointestinal toxicity and low discontinuation rates 8

9 Advancing Ozanimod in Inflammatory Bowel Disease Ozanimod Ph II Data in UC Ozanimod Ph II Data in CD Inflammatory Bowel Disease 2.3M $21B Clinical Remission Clinical Response Endoscopic Response 21% 51% 33% Clinical Remission Clinical Response Endoscopic Response 46% 66% 27% Ph III TRUE NORTH TM enrollment completion expected mid-2019 Ph III trial in Crohn s Disease initiated 9

10 Multiple Future Growth Drivers for OTEZLA and Ozanimod OTEZLA Ph III STYLE study in scalp psoriasis Behҫet s disease indication Ph III ADVANCE study in mild to moderate plaque psoriasis Ph IIIb DISCREET study in genital psoriasis Ph III SPROUT study in pediatric moderate to severe plaque psoriasis Ph IV study in moderate psoriatic arthritis Ozanimod Ph III YELLOWSTONE study in Crohn s disease initiated Ph III TRUE NORTH enrollment in UC on track for completion in mid

11 5 New Late-Stage Products Expected to Launch Through 2020 Ozanimod U.S. NDA and EU MAA submissions planned for Q1:19 TRUE NORTH UC trial enrollment targeted for completion in mid-2019 Fedratinib U.S. NDA submission in myelofibrosis expected by YE18 EU MAA submission planned in 2019 Liso-cel U.S. approval now expected in RR DLBCL in mid-2020 Data from Ph I CLL trial to be presented at ASH 2018 Luspatercept MEDALIST and BELIEVE to be presented at ASH U.S. and EU regulatory submissions expected in H1:19 bb2121 Clinical program in earlier lines advancing U.S. approval expected in highly refractory MM in 2020; KarMMa to complete enrollment by YE18 11

12 CHANGING THE COURSE OF HUMAN HEALTH THROUGH BOLD PURSUITS IN SCIENCE Credit Suisse 27 th Annual Healthcare Conference November 14, 2018