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


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.

2

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

3

Deploying a Strategy to Grow Through 2020 and Beyond

ExecuteDeliveringon 2020

AcceleratePositioning toGrow Beyond

2020

ExpandCreating

SustainableGrowth

4

MultipleMyeloma

Accelerating Diversification by Advancing Medicines to Transform the Treatment of Diseases

5

Market Opportunity$27BIncidence60K

Non-Hodgkin Lymphoma


MyeloidDiseases


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

6


Non-Hodgkin Lymphoma


MyeloidDiseases




MultipleSclerosis




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

7

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



Ozanimod – Advancing Potentially Differentiated Profile in Relapsing MS

8

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


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

9

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



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-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

11

Luspatercept

Liso-cel

Ozanimod

Fedratinib

bb2121

Credit Suisse 27th Annual Healthcare Conference

November 14, 2018


PURSUITS IN SCIENCE


PURSUITS IN SCIENCE

credit suisse 27 annual healthcare conference · 2019-08-22 · credit suisse 27th annual...

Documents