Credit Suisse 27 Annual Healthcare Conference · 2019-08-22 · Credit Suisse 27th Annual...
Transcript of Credit Suisse 27 Annual Healthcare Conference · 2019-08-22 · Credit Suisse 27th Annual...
Credit Suisse 27th Annual Healthcare Conference
November 14, 2018
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
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’scurrent plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertakeno obligation to update any forward-looking statement in light of new information or future events, except as otherwiserequired by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult topredict and are generally beyond our control. Actual results or outcomes may differ materially from those implied bythe forward-looking statements as a result of the impact of a number of factors, many of which are discussed in moredetail 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 www.Celgene.com in the “Investor Relations” section.
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Our Mission and Vision
Celgene is building a preeminent global biopharmaceutical company focusedon the discovery, development and commercialization of innovative therapies for patients with cancer, immune-inflammatory, and other unmet medical needs
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Deploying a Strategy to Grow Through 2020 and Beyond
ExecuteDeliveringon 2020
AcceleratePositioning toGrow Beyond
2020
ExpandCreating
SustainableGrowth
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MultipleMyeloma
Accelerating Diversification by Advancing Medicines to Transform the Treatment of Diseases
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Market Opportunity$27BIncidence60K
Non-Hodgkin Lymphoma
Market Opportunity$17BIncidence90K
MyeloidDiseases
Market Opportunity$5BIncidence65K
Psoriasis / Psoriatic Arthritis
Market Opportunity$26BPrevalence5M
MultipleSclerosis
Market Opportunity$23BPrevalence650K
Inflammatory Bowel Disease
Market Opportunity$21BPrevalence2.3M
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
HEMATOLOGY & ONCOLOGY
INFLAMMATION & IMMUNOLOGY
MultipleMyeloma
Accelerating Diversification by Advancing Medicines to Transform the Treatment of Diseases
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Market Opportunity$27BIncidence60K
Non-Hodgkin Lymphoma
Market Opportunity$17BIncidence90K
MyeloidDiseases
Market Opportunity$5BIncidence65K
Psoriasis / Psoriatic Arthritis
Market Opportunity$26BPrevalence5M
MultipleSclerosis
Market Opportunity$23BPrevalence650K
Inflammatory Bowel Disease
Market Opportunity$21BPrevalence2.3M
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
HEMATOLOGY & ONCOLOGY
INFLAMMATION & IMMUNOLOGY
OTEZLA® Is Positioned for Continued Strong Growth
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ExpansionOpportunities
ExpansionOpportunities
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-to-moderate plaque psoriasis
• Ongoing investment in brand awareness and positioning, including expansion of the post-topical market opportunity
Source: Based on SHS Claims data through Jun’18, Un projected Claims including Bridge and PAP, data subjected to restateTotal Branded Rx Share based on SHS Prescriber data through Aug’18, data subjected to restateDecision Resources. Psoriasis Disease Landscape and Forecast, updated May 2017
Competitive Positioningin the US Psoriasis Market
Competitive Positioningin the US Psoriasis Market
#1 New to Brand Share:
#2 Total Branded Rx Share:
#1 Pre-biologic Rx Share:
36%
21%
23%
~10 Million diagnosed psoriasis
patients in core markets
Approximately60%
of diagnosedpsoriasis patients remain untreated
Biologic Step-free Access: 80%
Significant Untapped OpportunitySignificant Untapped Opportunity
Psoriasis / Psoriatic Arthritis
Market Opportunity$26BPrevalence5M
Ozanimod – Advancing Potentially Differentiated Profile in Relapsing MS
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Ozanimod – A Potentially Differentiated Oral in MS
Competitive Profile Based on Two Large Phase III Trials
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
MultipleSclerosis
Market Opportunity$23BPrevalence650K
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
Advancing Ozanimod in Inflammatory Bowel Disease
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Ozanimod Ph II Data in UCOzanimod Ph II Data in UC
Clinical Remission
Clinical Response
Endoscopic Response
Ozanimod Ph II Data in CDOzanimod Ph II Data in CD
21%
51%
33%
Clinical Remission
Clinical Response
Endoscopic Response
46%
66%
27%
Ph III TRUE NORTHTM enrollment completion expected mid-2019
Ph III trial in Crohn’s Diseaseinitiated
Inflammatory Bowel Disease
Market Opportunity$21BPrevalence2.3M
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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-2019
– U.S. approval now expected in RR DLBCL in mid-2020– Data from Ph I CLL trial to be presented at ASH 2018
– MEDALIST™ and BELIEVE™ to be presented at ASH– U.S. and EU regulatory submissions expected in H1:19
– U.S. NDA and EU MAA submissions planned for Q1:19– TRUE NORTH™ UC trial enrollment targeted for completion in mid-2019
– U.S. NDA submission in myelofibrosis expected by YE18– EU MAA submission planned in 2019
– Clinical program in earlier lines advancing– U.S. approval expected in highly refractory MM in 2020; KarMMa™ to complete
enrollment by YE18
5 New Late-Stage Products Expected to Launch Through 2020
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Luspatercept
Liso-cel
Ozanimod
Fedratinib
bb2121
Credit Suisse 27th Annual Healthcare Conference
November 14, 2018
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE
CHANGING THE COURSE OFHUMAN HEALTH THROUGH BOLD
PURSUITS IN SCIENCE