q4 and full year 2018 conference call...q4:18 conference call mark alles, chairman & chief...

Q4 and Full Year 2018 Conference Call

January 31, 2019

CHANGING THE COURSE OF

HUMAN HEALTH THROUGH BOLD

PURSUITS IN SCIENCE

Q4:18 Conference Call

Mark Alles, Chairman & Chief Executive Officer

Nadim Ahmed, President, Hematology & Oncology

Jay Backstrom, MD, Chief Medical Officer

Q&A

David Elkins, Chief Financial Officer

2

Terrie Curran, President, Inflammation & Immunology

3

Important Information For Investors And Stockholders

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. It does not constitute a prospectus

or prospectus equivalent document. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of

1933, as amended.

In connection with the proposed transaction between Bristol-Myers Squibb Company (“Bristol-Myers Squibb”) and Celgene Corporation (“Celgene”), Bristol-Myers Squibb and

Celgene will file relevant materials with the Securities and Exchange Commission (the “SEC”), including a Bristol-Myers Squibb registration statement on Form S-4 that will include

a joint proxy statement of Bristol-Myers Squibb and Celgene that also constitutes a prospectus of Bristol-Myers Squibb, and a definitive joint proxy statement/prospectus will be

mailed to stockholders of Bristol-Myers Squibb and Celgene. INVESTORS AND SECURITY HOLDERS OF BRISTOL-MYERS SQUIBB AND CELGENE ARE URGED TO READ

THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY

BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Investors and security holders will be able to obtain free copies of the registration

statement and the joint proxy statement/prospectus (when available) and other documents filed with the SEC by Bristol-Myers Squibb or Celgene through the website maintained

by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Bristol-Myers Squibb will be available free of charge on Bristol-Myers Squibb’s internet website

at http://www.bms.com under the tab, “Investors” and under the heading “Financial Reporting” and subheading “SEC Filings” or by contacting Bristol-Myers Squibb’s Investor

Relations Department through https://www.bms.com/investors/investor-contacts.html. Copies of the documents filed with the SEC by Celgene will be available free of charge on

Celgene’s internet website at http://www.celgene.com under the tab “Investors” and under the heading “Financial Information” and subheading “SEC Filings” or by contacting

Celgene’s Investor Relations Department at [email protected].

Certain Information Regarding Participants

Bristol-Myers Squibb, Celgene, and their respective directors and executive officers may be considered participants in the solicitation of proxies in connection with the proposed

transaction. Information about the directors and executive officers of Bristol-Myers Squibb is set forth in its Annual Report on Form 10-K for the year ended December 31, 2017,

which was filed with the SEC on February 13, 2018, its proxy statement for its 2018 annual meeting of stockholders, which was filed with the SEC on March 22, 2018, and its

Current Report on Form 8-K, which was filed with the SEC on August 28, 2018. Information about the directors and executive officers of Celgene is set forth in its Annual Report on

Form 10-K for the year ended December 31, 2017, which was filed with the SEC on February 7, 2018, its proxy statement for its 2018 annual meeting of stockholders, which was

filed with the SEC on April 30, 2018, and its Current Reports on Form 8-K, which were filed with the SEC on June 1, 2018, June 19, 2018 and November 2, 2018. Other information

regarding the participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the joint proxy

statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when they become available. You may obtain these documents

(when they become available) free of charge through the website maintained by the SEC at http://www.sec.gov and from Investor Relations at Bristol-Myers Squibb or Celgene as

described above.

http://www.sec.gov/

http://www.bms.com/

https://www.bms.com/investors/investor-contacts.html

http://www.celgene.com/

mailto:[email protected]

http://www.sec.gov/

Forward-Looking Statements and Adjusted Financial Information

4

This communication contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can generally identify forward-looking

statements by the use of forward-looking terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “explore,” “evaluate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” or “will,” or the negative

thereof or other variations thereon or comparable terminology. These forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond Bristol-Myers Squibb’s and Celgene’s control.

Statements in this communication regarding Bristol-Myers Squibb, Celgene and the combined company that are forward-looking, including projections as to the anticipated benefits of the proposed transaction, the impact of the proposed transaction on

Bristol-Myers Squibb’s and Celgene’s business and future financial and operating results, the amount and timing of synergies from the proposed transaction, the terms and scope of the expected financing for the proposed transaction, the aggregate

amount of indebtedness of the combined company following the closing of the proposed transaction, expectations regarding cash flow generation, accretion to non-GAAP earnings per share, capital structure, debt repayment, adjusted leverage ratio and

credit ratings following the closing of the proposed transaction, Bristol-Myers Squibb’s ability and intent to conduct a share repurchase program and declare future dividend payments, the combined company’s pipeline, intellectual property protection and

R&D spend, the timing and probability of a payment pursuant to the contingent value right consideration, and the closing date for the proposed transaction, are based on management’s estimates, assumptions and projections, and are subject to

significant uncertainties and other factors, many of which are beyond Bristol-Myers Squibb’s and Celgene’s control. These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to

Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and

pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that

may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation

affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the

ultimate outcome of any litigation matter. These factors also include the combined company’s ability to execute successfully its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products,

including assumptions about the combined company’s ability to retain patent exclusivity of certain products, the impact and result of governmental investigations, the combined company’s ability to obtain necessary regulatory approvals or obtaining these

without delay, the risk that the combined company’s products prove to be commercially successful or that contractual milestones will be achieved. Similarly, there are uncertainties relating to a number of other important factors, including: results of clinical

trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. FDA and other regulatory authorities, investigational review boards

at clinical trial sites and publication review bodies; the ability to enroll patients in planned clinical trials; unplanned cash requirements and expenditures; competitive factors; the ability to obtain, maintain and enforce patent and other intellectual property

protection for any product candidates; the ability to maintain key collaborations; and general economic and market conditions. Additional information concerning these risks, uncertainties and assumptions can be found in Bristol-Myers Squibb’s and

Celgene’s respective filings with the SEC, including the risk factors discussed in Bristol-Myers Squibb’s and Celgene’s most recent Annual Reports on Form 10-K, as updated by their Quarterly Reports on Form 10-Q and future filings with the SEC.

It should also be noted that projected financial information for the combined businesses of Bristol-Myers Squibb and Celgene is based on management’s estimates, assumptions and projections and has not been prepared in conformance with the

applicable accounting requirements of Regulation S-X relating to pro forma financial information, and the required pro forma adjustments have not been applied and are not reflected therein. None of this information should be considered in isolation from,

or as a substitute for, the historical financial statements of Bristol-Myers Squibb or Celgene. Important risk factors could cause actual future results and other future events to differ materially from those currently estimated by management, including, but

not limited to, the risks that: a condition to the closing of the proposed acquisition may not be satisfied; a regulatory approval that may be required for the proposed acquisition is delayed, is not obtained or is obtained subject to conditions that are not

anticipated; Bristol-Myers Squibb is unable to achieve the synergies and value creation contemplated by the proposed acquisition; Bristol-Myers Squibb is unable to promptly and effectively integrate Celgene’s businesses; management’s time and

attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; the credit ratings of the combined company declines following the proposed

acquisition; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company; Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel; and the announcement or the consummation of

the proposed acquisition has a negative effect on the market price of the capital stock of Bristol-Myers Squibb and Celgene or on Bristol-Myers Squibb’s and Celgene’s operating results.

No assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do occur, what impact they will have on the results of operations, financial condition or cash flows of Bristol-Myers

Squibb or Celgene. Should any risks and uncertainties develop into actual events, these developments could have a material adverse effect on the proposed transaction and/or Bristol-Myers Squibb or Celgene, Bristol-Myers Squibb’s ability to

successfully complete the proposed transaction and/or realize the expected benefits from the proposed transaction. You are cautioned not to rely on Bristol-Myers Squibb’s and Celgene’s forward-looking statements. These forward-looking statements

are and will be based upon management’s then-current views and assumptions regarding future events and operating performance, and are applicable only as of the dates of such statements. Neither Bristol-Myers Squibb nor Celgene assumes any duty

to update or revise forward-looking statements, whether as a result of new information, future events or otherwise, as of any future date.

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.

http://www.celgene.com/

Mark AllesChairman & Chief Executive Officer



PURSUITS IN SCIENCE

FY:18 Strong Operating Results & Pipeline Momentum

Delivering Excellent Operating Results

− Exceeded 2018 top- and bottom-line guidance; 2019 guidance of total revenue of

$17.0B-$17.2B and adjusted diluted earnings per share (EPS) of $10.60-$10.80

− Reaffirming 2020 outlook: total revenue of $19-$20B & adj. diluted EPS of >$12.50

Accelerating Inline and Pipeline Assets

− Five late-stage assets on-track for U.S. launches expected through 2020 –

ozanimod, fedratinib, luspatercept, liso-cel and bb2121

− Increasingly productive early R&D engine, including 7 novel INDs filed in 2018

Announced Acquisition by Bristol-Myers Squibb

− Creates a leading biopharma company while enhancing global leadership and

core competencies in high-value therapeutic areas, including oncology and I&I

− Recognizes and unlocks significant value for Celgene shareholders 6

▪ Two companies with one mission – discover, develop and deliver the most innovative medicines to patients with unmet medical needs across the continuum of care

▪ Recognizes and unlocks significant value for Celgene shareholders

– Delivers immediate and substantial cash value

– Provides meaningful participation in the combined company’s future growth

– Additional cash via dividends and potential contingent value right (CVR)

▪ Enhances global leadership and core competencies in high-value therapeutic categories across small molecules, biologics and cell therapies

▪ Accelerates research and development programs for sustainable long-term growth

▪ Combined company has the capabilities and financial strength to continue investing in external research partners

▪ Builds on the skills, dedication and passion of talented employees

Bristol-Myers Squibb: The Right Transaction for Celgene

7

David ElkinsChief Financial Officer



PURSUITS IN SCIENCE

Q4:18 & FY:18 Financial Highlights

2018 Operating Results

− Q4:18 Y/Y net product sales grew 16% to $4.0B and adjusted diluted EPS grew 20% to $2.39

− 2018 Y/Y net product sales grew 18% to $15.3B and adjusted diluted EPS grew 19% to $8.87

2019 Guidance Based on Continued Operating Momentum

− Volume driven sales growth from REVLIMID®, POMALYST®, ABRAXANE ® and OTEZLA®

− Continued investment in key R&D programs while driving meaningful SG&A leverage

9

Strong Execution on Operating Metrics

− Strong product growth across the portfolio and geographies

− Significant R&D investments to support planned regulatory submissions

Strategic and Balanced Capital Deployment

− Invested ~$9.7B in acquisitions and over $3.5B in internal programs for FY 2018

− ~$6B in cash and marketable securities as of December 31, 2018

Q4:18 Total Net Product Sales

Q4:16 Q4:17 Q4:18

$ M

illio

ns

↑17% ↑17%↑16%

$0

$500

$1,000

$1,500

$2,000

$2,500

$3,000

$3,500

$4,000

$4,500

Q4:17 Volume Price Fx /Hedge

Q4:18

↑16.0%↓0.5%↑15.2% ↑1.3%

Contribution to Q4:18 Total Net Product Sales Growth

$ M

illio

ns

Total Net Product Sales

Footnote: Growth Rates = Growth vs. Prior Year Period10

$2,977

$3,479

$4,036

FY:18 Total Net Product Sales

2016 2017 2018

$ M

illio

ns

↑22% ↑16% ↑18%

$0

$2,000

$4,000

$6,000

$8,000

$10,000

$12,000

$14,000

$16,000

2017 Volume Price Fx /Hedge

2018

↑17.7%↓0.4%↑15.2% ↑2.9%

Contribution to 2018 Total Net Product Sales Growth

$ M

illio

ns

Total Net Product Sales

11Footnote: Growth Rates = Growth vs. Prior Year Period

$11,185

$12,973

$15,265

Q4:18 Adjusted Diluted Earnings Per Share

Q4:16 Q4:17 Q4:18

↑36% ↑24%

Do

llars

Per

Sh

are

↑20%

Q4:17 Oper. Income

OIE Tax Rate

Share Count

Q4:18

Do

llars

Per

Sh

are

$2.39$0.30$2.00 ($0.04) $0.25($0.12)

12

Contribution to Q4:18 Adjusted Diluted EPSAdjusted Diluted EPS

Footnote: Growth Rates = Growth vs. Prior Year Period

$1.61

$2.00

$2.39

FY:18 Adjusted Diluted Earnings Per Share

2016 2017 2018

↑26% ↑25%

Do

llars

Per

Sh

are

↑19%

Do

llars

Per

Sh

are

$8.87$0.97$7.44 ($0.06) $0.81($0.29)

13

Contribution to 2018 Adjusted Diluted EPSAdjusted Diluted EPS

Footnote: Growth Rates = Growth vs. Prior Year Period

$5.94

$8.87

$7.44

2017 Oper. Income

OIE Tax Rate Share Count

2018

Key P&L Line Items (Adjusted)

Q4:18∆ vs.

Q4:17FY2018

∆ vs.

FY2017

Product Gross Margin 96.0% ↓ ~80 bps 96.4% ↓ ~30 bps

R&D Expenses

% of revenue$919M22.8%

↑ ~80 bps$3,509M

23.0%↑ ~190 bps

SG&A Expenses

% of revenue$762M18.9%

↓ ~ 80 bps$2,747M

18.0%↑ ~50 bps

Operating Margin 54.4% ↓ ~70 bps 55.5% ↓ 250 bps

Effective Tax Rate 15.4% ↑~140 bps 16.5% ↑ 60 bps

14

Capital Allocation

▪ Cash flow from operations was approximately $5.2B during 20181

▪ In 2018, invested ~$9.7B in new acquisitions2

▪ In 2018, purchased ~$6.1B of shares

($ in Billions) 12/31/18 12/31/17

Cash, Cash Equivalents, Marketable

Debt Securities and Publicly-Traded

Equity Securities

$6.04 $12.04

151 Includes $1.1B of cash outflow related to the acquisition of Impact Biomedicines 2 Comprised of $8.6B and $1.1B for Juno Therapeutics and Impact Biomedicines, respectively

2019 Guidance

2019 Guidance∆ vs.

2018

Total Revenue $17.0B-$17.2B ↑ ~12%1

REVLIMID® Net Product Sales ~$10.8B ↑ ~12%

POMALYST®/IMNOVID® Net Product Sales ~$2.4B ↑ ~18%

OTEZLA® Net Product Sales ~$1.9B ↑ ~18%

ABRAXANE® Net Product Sales ~$1.1B ↑ ~4%

Adjusted Operating Margin ~57.5% ↑ ~200 bps

Adjusted Tax Rate ~17.0% ↑~ 50 bps

Adjusted Diluted EPS $10.60-$10.80 ↑ ~21%1

Weighted Average Diluted Shares ~715M ↓~20M

161. Using mid-point of the range

Nadim AhmedPresident, Hematology & Oncology



PURSUITS IN SCIENCE

Q4:18 & FY:18 Hematology & Oncology Franchise Results

Strong Net Product Sales and Operating Momentum– Net product sales: Q4:18 - $3.6B, +15% Y/Y; FY:18 - $13.7B +17% Y/Y

– Sales performance driven by strong demand across geographies and brands

Growth Drivers Delivering− REVLIMID® continues to grow across geographies with NSCT and post-ASCT maintenance adoption

− POMALYST®/IMNOVID® growth continues through gains in market share and duration

− REVLIMID® + rituximab (R2) dossiers for R/R indolent lymphoma subtypes submitted in the U.S. and EU

− ABRAXANE IO combination U.S. approvals in 1L mTNBC and 1L metastatic non-squamous NSCLC expected in 2019

Advancement and Expansion of Innovative Pipeline− Luspatercept: Ph III MEDALIST™ trial (MDS) and Ph III BELIEVE™ trial (beta-thalassemia) presented at ASH 2018

− Liso-cel (JCAR017): Initial data from the Ph I/II TRANSCEND™ R/R CLL trial presented at ASH 2018

− BCMA campaign:

− bb2121: KarMMa™ pivotal trial in RRMM completed enrollment in Q4:18

− bb21217 and JCARH125 data presented at ASH 2018

− Fedratinib U.S. NDA submitted in myelofibrosis

− Launch planning initiated for anticipated near-term approvals

18

$170$219

$283

$393$124

$159

$159

$174

Q4:15 Q4:16 Q4:17 Q4:18U.S. ROW

$957$1,187

$1,473$1,729

$604

$621

$715

$820

Q4:15 Q4:16 Q4:17 Q4:18U.S. ROW

Current Results & Potential Future Growth Drivers

Q4:18 & FY:18 IMiD® Net Sales Summary

• REVLIMID® - Q4:18 net sales ~$2.5B, +16% Y/Y;

FY:18 net sales ~$9.7B, +18% Y/Y

• POMALYST® - Q4:18 net sales $567M, +28% Y/Y;

FY:18 net sales ~$2.0B, +26% Y/Y

• Strong growth with contribution from increased market

share, duration and triplet combination adoption

• Clinical development and potential future growth drivers:

– REVLIMID®

• REVLIMID®-based triplet regimens in NDMM

(RVd, Rd-daratumumab)

• Anticipate R2 approval in R/R indolent lymphoma subtypes

• Ph III ROBUST® study in 1st line ABC-subtype diffuse large B-cell

lymphoma (event-driven)

– POMALYST®

• Newer triplet regimens expected to increase share and duration

• Anticipate PVd approval in EU and Japan

19

REVLIMID® Net Sales ($M)

Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.

$1,561

$1,808

$2,188

$2,549

POMALYST® Net Sales ($M)

$294

$378

$442

$567


Q4:18 & FY:18 ABRAXANE® Net Sales Summary

$179 $172 $155

$178

$91 $94 $96

$91

Q4:15 Q4:16 Q4:17 Q4:18

U.S. ROW

$269$270$251

$266

ABRAXANE® Net Sales ($M)

20

• Q4:18 net sales $269M, +7% Y/Y;

• FY:18 net sales ~$1.1B, +7% Y/Y

• Potential future growth drivers:

− Ph III apact® trial of ABRAXANE® in adjuvant pancreatic cancer data (event-driven)

− First approved IO combination regimen for 1L metastatic squamous NSCLC:

− Pembrolizumab + ABRAXANE® approved by FDA on October 30, 20181

− Upcoming PDUFA dates for IO combinations:

− Atezolizumab + ABRAXANE® in 1L metastatic TNBC (March 12, 2019) 2

− Atezolizumab + ABRAXANE® in 1L metastatic non-squamous NSCLC (Sept 2, 2019) 2

1 Pembrolizumab + ABRAXANE® is a Merck & Co. approval2 Atezolizumab + ABRAXANE® are Genentech, a member of the Roche Group, action dates

Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention.

Terrie CurranPresident, Inflammation & Immunology



PURSUITS IN SCIENCE

Q4:18 & FY:18 I&I Franchise Results

22

Continued Positive Momentum for OTEZLA®

– Achieved updated 2018 revenue guidance

– Strong demand driving significant growth across geographies

– Favorable access positions in the U.S., key EU markets, and Japan

Advancing the OTEZLA® Lifecycle Development Plan

– Submitted Behҫet’s disease sNDA in the U.S. and JNDA in Japan

– Positive Ph III STYLETM data in scalp psoriasis

– Initiated additional Ph III studies in new and complementary patient populations

Progressing Future I&I Growth Drivers

– Ozanimod RMS/RRMS regulatory filings in U.S. and EU on track for Q1:19

– Enrolling Ph III trials for ozanimod in ulcerative colitis (UC) and Crohn’s disease

– Positive Ph II 52-week data for RPC4046 in eosinophilic esophagitis (EoE)

– Completion of enrollment in Ph II trial of CC-220 in SLE expected in 2019

0%

10%

20%

30%

40%

ENBREL STELARA HUMIRA COSENTYXOTEZLA TALTZ Acitretin MethotrexateCyclosporine SILIQ TREMFYA

$167

$268 $303 $360 $16

$37

$68

$88

Q4:15 Q4:16 Q4:17 Q4:18U.S. ROW

Q4:18 & FY:18 OTEZLA® Performance and Future Growth Drivers

23


• Q4:18 net sales $448M, +21% Y/Y

• FY:18 net sales ~$1.6B, +26% Y/Y

• Continued robust volume-based growth

– Maintaining U.S. new-to-brand leadership despite increasingly competitive market

– Achieved dynamic market leadership in France; continue to drive fastest post-launch uptake in Japan

• Potential future growth drivers for OTEZLA®

– Behҫet’s disease1: EMA submission H1:19, anticipating H2:19 approvals in US (July 21 PDUFA date) and Japan

– Scalp psoriasis label enhancement: sNDA submission expected in Q2:19

– Ph III/IIIb trials in pediatric, genital, and mild to moderate plaque psoriasis

OTEZLA® Net Sales ($M)

1Proposed indication: treatment of adult patients with oral ulcers associated with Behҫet’s disease2Source: SHS claims data through Nov 2018, last updated Jan 17,2019. includes patients on bridge and PAP for OTEZLA.Certain prior year amounts have been rounded +/- $1M to conform to the current year rounding convention

OTEZLA

35.3%

OTEZLA® New to Brand Share in Psoriasis2

(Normalized Patient Equivalents)

$183

$305

$371

$448

Jay Backstrom, MDChief Medical Officer



PURSUITS IN SCIENCE

0.3500.241

0.1810.000

0.100

0.200

0.300

0.400

0.500

0.600

1

Ad

juste

d A

RR

(±95%

CI)

0.276 0.218 0.1720

0.1

0.2

0.3

0.4

0.5

0.6

1

Ad

juste

d A

RR

(±95%

CI)

Ozanimod Regulatory Filings Supported by Clinical Efficacy & Safety Data from Two Phase III Trials in Patients with RMS

25

SUNBEAMTM – Over 1 year

448 451 447n

31% reductionP=0.0013

48% reductionP<0.0001

IFN β-1a

30 µg

(n= 885)

Ozanimod

0.5 mg

(n = 892)

Ozanimod

1.0 mg

(n = 882)

Any AE701

(79.2%)

585

(65.6%)

592

(67.1%)

Serious AE39

(4.4%)

47

(5.3%)

41

(4.6%)

AE Leading to Study Drug

Discontinuation

34

(3.8%)

21

(2.4%)

26

(2.9%)

Death on study** 01

(0.1%)0

RADIANCETM PART B – Over 2 years

SUNBEAMTM and RADIANCETM PART B Pooled

Summary of Adverse Events

21% reductionP=0.0167

38% reductionP<0.0001

441 439 433n

**Drowning, unrelated to treatment, on study day 637

• No subjects had a 2nd degree or higher AV block

• Rate of infection with ozanimod was comparable

to treatment with IFN β-1a (Avonex®)

• Ozanimod resulted in low levels of liver enzyme

elevations

IFN β-1a Ozanimod 1.0 mgOzanimod 0.5 mg

Data from AAN 2018: Cree, et. al. #006 and Kappos, et.al, #005

Based on the Poisson regression model, adjusted for region (Eastern Europe vs rest of world), age at baseline, and baseline number of gadolinium-enhancing lesions. Natural log transformation of time on study included as an offset term.

ARR, annualized relapse rate; CI, confidence interval; IFN β-1a, interferon β-1a; ITT, intent-to-treat.

IFN β-1a Ozanimod 1.0 mgOzanimod 0.5 mg

Fedratinib

Luspatercept

Liso-cel

bb2121

Ozanimod: Advancing a Next-Generation S1P Modulator for RMS and IBD

26

Ozanimod • Potentially differentiated risk-benefit profile in RMS

• U.S. NDA and EU MAA submissions for RMS/RRMS on track for Q1:19

− Non-clinical bridging studies, PK/PD and DDI trials completed

• Ph III TRUE NORTH™ ulcerative colitis trial enrollment targeted for completion in H1:19

• Ph III YELLOWSTONE™ Crohn’s disease program enrolling

Ozanimod

Luspatercept

Liso-cel

bb2121

Fedratinib: Building Leadership in Myelofibrosis

27

Fedratinib

• Highly selective JAK2 inhibitor

• Studied in ruxolitinib-naïve and ruxolitinib-exposed patients with myelofibrosis

• NDA submitted for myelofibrosis; U.S. approval expected by year-end 2019

• EU MAA submission planned in H1:19

• FREEDOM/FREEDOM-2 myelofibrosis trials advancing

• Ph I/II combination trial with luspatercept planned

Liso-cel

bb2121

Ozanimod

Fedratinib

Luspatercept: A Potential Platform Molecule for Chronic Anemias

28

Luspatercept

• First-in-class erythroid maturation agent

• U.S. and EU regulatory submissions for RS+ MDS and transfusion-dependent beta-thalassemia on-track for H1:19

• Broad development strategy

– Ph III COMMANDS trial in ESA-naïve MDS

– Randomized Ph II BEYOND trial in non-transfusion dependent beta-thalassemia

– Ph II myelofibrosis data expected in H2:19

In collaboration with Acceleron Pharma

Luspatercept

bb2121

Ozanimod

Fedratinib

Liso-cel: Harnessing Immunotherapy in NHL and CLL

29

Liso-cel

• Potential best-in-class CD19 CAR T profile

• BLA submission expected in H2:19; U.S. approval expected in mid-2020

• Early Ph I/II data in R/R CLL (BTK failures) compelling; Pivotal Ph II trial initiating

• Clinical trials in earlier lines of DLBCL underway

− Ph III TRANSFORM in 2nd line transplant eligible

− Ph II PILOT in 2nd line non-transplant eligible

Liso-cel

Luspatercept

Ozanimod

Fedratinib

bb2121: Potential to Redefine the Treatment of Multiple Myeloma

30

bb2121

• Potential first-in-class BCMA CAR T for multiple myeloma

• Pivotal KarMMa™ trial enrollment completed

• U.S. approval in highly refractory MM expected in H2:20

• Clinical program in earlier lines of MM advancing

− Ph III KarMMa™ 3 in 3rd line+

− Ph II KarMMa™ 2 in 2nd line

− Ph II NDMM trial planned in H2:19

Program in collaboration with bluebird bio

Q4 and Full Year 2018 Conference Call

January 31, 2019



PURSUITS IN SCIENCE

Q&A



PURSUITS IN SCIENCE

Use of Non-GAAP Financial Measures and

Reconciliation Tables



PURSUITS IN SCIENCE

Use of Non-GAAP Financial Measures

34


In addition to financial information prepared in accordance with U.S. GAAP, this document also contains certain non-GAAP financial measures

based on management’s view of performance including:

• Adjusted research and development expense

• Adjusted selling, general and administrative expense

• Adjusted operating margin

• Adjusted net income

• Adjusted earnings per share

Management uses such measures internally for planning and forecasting purposes and to measure the performance of the Company. We believe

these adjusted financial measures provide useful and meaningful information to us and investors because they enhance investors’ understanding of

the continuing operating performance of our business and facilitate the comparison of performance between past and future periods.

These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information

prepared in accordance with U.S. GAAP. When preparing these supplemental non-GAAP financial measures we typically exclude certain GAAP

items that management does not consider to be normal, recurring cash operating expenses but that may not meet the definition of unusual

or non-recurring items. Other companies may define these measures in different ways. The following categories of items are excluded from

adjusted financial results:

Acquisition and Divestiture-Related Costs: We exclude the impact of certain amounts recorded in connection with business combinations and

divestitures from our adjusted financial results that are either non-cash or not normal, recurring operating expenses due to their nature, variability

of amounts, and lack of predictability as to occurrence and/or timing. These amounts may include non-cash items such as the amortization of

acquired intangible assets, amortization of purchase accounting adjustments to inventories, intangible asset impairment charges and expense or

income related to changes in the estimated fair value measurement of contingent consideration and success payments. We also exclude transaction

and certain other cash costs associated with business acquisitions and divestitures that are not normal, recurring operating expenses, including

severance costs which are not part of a formal restructuring program.


35

Share-Based Compensation Expense: We exclude share-based compensation from our adjusted financial results because share-based compensation

expense, which is non-cash, fluctuates from period to period based on factors that are not within our control, such as our stock price on the dates

share-based grants are issued.

Collaboration-Related Upfront Expenses: We exclude collaboration-related upfront expenses from our adjusted financial results because we do not

consider them to be normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to occurrence

and/or timing. Upfront payments to collaboration partners are made at the commencement of a relationship anticipated to continue for a multiyear

period and provide us with intellectual property rights, option rights and other rights with respect to particular programs. The variability of amounts

and lack of predictability of collaboration-related upfront expenses makes the identification of trends in our ongoing research and development

activities more difficult. We believe the presentation of adjusted research and development, which does not include collaboration related

upfront expenses, provides useful and meaningful information about our ongoing research and development activities by enhancing investors’

understanding of our normal, recurring operating research and development expenses and facilitates comparisons between periods and with respect

to projected performance. All expenses incurred subsequent to the initiation of the collaboration arrangement, such as research and development

cost-sharing expenses/reimbursements and milestone payments up to the point of regulatory approval are considered to be normal, recurring

operating expenses and are included in our adjusted financial results.

Research and Development Asset Acquisition Expense: We exclude costs associated with acquiring rights to pre-commercial compounds because we

do not consider such costs to be normal, recurring operating expenses due to their nature, variability of amounts, and lack of predictability as to

occurrence and/or timing. Research and development asset acquisition expenses includes expenses to acquire rights to pre-commercial compounds

from a collaboration partner when there will be no further participation from the collaboration partner or other parties. The variability of amounts

and lack of predictability of research and development asset acquisition expenses makes the identification of trends in our ongoing research and

development activities more difficult. We believe the presentation of adjusted research and development, which does not include research and

development asset acquisition expenses, provides useful and meaningful information about our ongoing research and development activities by

enhancing investors’ understanding of our normal, recurring operating research and development expenses and facilitates comparisons between

periods and with respect to projected performance.


36

Restructuring Costs: We exclude costs associated with restructuring initiatives from our adjusted financial results. These costs include amounts associated

with facilities to be closed, employee separation costs and costs to move operations from one location to another. We do not frequently undertake

restructuring initiatives and therefore do not consider such costs to be normal, recurring operating expenses.

Certain Other Items: We exclude certain other significant items that may occur occasionally and are not normal, recurring cash operating expenses from

our adjusted financial results. Such items are evaluated on an individual basis based on both the quantitative and the qualitative aspect of their nature and

generally represent items that, either as a result of their nature or magnitude, we would not anticipate occurring as part of our normal business on a regular

basis. While not all-inclusive, examples of certain other significant items excluded from adjusted financial results would be: significant litigation-related

loss contingency accruals and expenses to settle other disputed matters and, effective for fiscal year 2018, changes in the fair value of our equity securities

upon the adoption of ASU 2016-01 (Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities).

Estimated Tax Impact From Above Adjustments: We exclude the net income tax impact of the non-tax adjustments described above from our adjusted

financial results. The net income tax impact of the non-tax adjustments includes the impact on both current and deferred income taxes and is based on the

taxability of the adjustment under local tax law and the statutory tax rate in the tax jurisdiction where the adjustment was incurred.

Non-Operating Tax Adjustments: We exclude the net income tax impact of certain other significant income tax items, which are not associated with our

normal, recurring operations (“Non-Operating Tax Items”), from our adjusted financial results. Non-Operating Tax Items include items which may occur

occasionally and are not normal, recurring operating expenses (or benefits), including adjustments related to acquisitions, divestitures, collaborations,

certain adjustments to the amount of unrecognized tax benefits related to prior year tax positions, the impact of tax reform legislation commonly referred

to as the Tax Cuts and Jobs Act (2017 Tax Act), and other similar items. We also exclude excess tax benefits and tax deficiencies that arise upon vesting or

exercise of share-based payments recognized as income tax benefits or expenses due to their nature, variability of amounts, and lack of predictability as to

occurrence and/or timing.

See the attached Reconciliations of GAAP to Adjusted Net Income for explanations of the amounts excluded and included to arrive at the adjusted

measures for the three- and twelve-month periods ended December 31, 2018 and 2017, and for the projected amounts for the twelve-month period ending

December 31, 2019.


37


38


39

Appendix



PURSUITS IN SCIENCE

Advancing a High Quality Pipeline with Significant Potential

OzanimodS1P1/5 agonist

UC

I & I

11


MS

RPC-4046Anti-IL-13

EoE

CC-220CELMoD

SLE

CC-90001 JNK inhibitor

IPF

CC-90006Anti-PD-1

PSOR


CD

CC-99677MK2 inhibitor

I&I

CC-486 DNMT inhibitor

AML

LuspaterceptTGFβ inhibitor

MDS, Beta-thalassemia

CC-90009CELMoDR/RAML

FT-1101BET inhibitorMDS, AML

Myeloid

Disease

10

Liso-celCD19 CAR T

R/R NHL

CC-486DNMT inhibitor

NHL

NHL & CLL

10

LuspaterceptTGFβ inhibitor

MF

CC-90002Anti-CD47

NHL

CC-90010BET inhibitor

NHLbb21217

BCMA CAR TRRMMCC-220

CELMoDRRMM

bb2121BCMA CAR T

RRMM

CC-92480CELMoDRRMM

Multiple

Myeloma

9Marizomib

Proteasome inhibitorGBM

CC-90011LSD1 inhibitorSolid Tumors

Solid

Tumors

9

EtigilimabAnti-TIGIT

Solid Tumors

JTX-2011ICOS agonistSolid Tumors

CC-90010BET inhibitorSolid Tumors

TislelizumabAnti-PD-1

Solid Tumors

FedratinibJAK2 kinase inhibitor

MF

CC-93269BCMA TCE

RRMM

JCARH125BCMA CAR T

RRMM

MSC-1Anti-LIF

Solid tumors

Liso-celCD19 CAR T

R/R CLL

GEM333CD3xCD33

AML

AG-270Mat2A inhibitorSolid tumors

TRPH-222CD22 ADC

NHL

CC-92252IL-2 mutein

I&I

AG-270Mat2A inhibitor

NHL

L E G E N D

Celgene has an exclusive option to license and/or option to acquire: TRPH-222,JTX-2011, Etigilimab, AG-270, and MSC-141

REVLIMID®

iMiDNDMM, RRMM

POMALYST®

iMiDRRMM

THALOMID®

iMiDNDMM, RRMM

REVLIMID®

iMiDMCL

ISTODAX®

HDAC inhibitorPTCL, CTCL

REVLIMID®

iMiDR/R NHL

ABRAXANE®

nab-paclitaxelPanC, NSCLC, mBC

REVLIMID®

iMiDDel 5q MDS

VIDAZA®

DNMT inhibitorMDS, AML

IDHIFA®

IDH2 inhibitorIDH2 R/RAML

OTEZLA®

PDE4 inhibitorPSOR, PSA

OTEZLA®

PDE4 inhibitorBehçet’s, Scalp PSOR

MarketPh I

2019 Milestones

Financial Performance❑ Total revenue $17.0B-$17.2B

❑ REVLIMID® net sales ~$10.8B

❑ POMALYST® net sales ~$2.4B

❑ OTEZLA® net sales ~$1.9B

❑ ABRAXANE® net sales ~$1.1B

❑ Adj. operating margin ~57.5%

❑ Adj. diluted EPS $10.60 to $10.80

Maximize Commercial Assets

REVLIMID

❑ FDA decision on sNDA for REVLIMID® - AUGMENTTM in R/R iNHL

❑ EMA CHMP decision on sNDA for RVd in NDMM

❑ Ph III ROBUST ® data – REVLIMID® in 1st line ABC-subtype DLBCL (event-driven)

POMALYST®/ IMNOVID®

❑ EMA CHMP decision on sNDA for PVd in RRMM

❑ Japan PMDA decision on sNDA for PVd in RRMM

OTEZLA®

❑ FDA decision on sNDA for OTEZLA® in Behҫet’s disease

❑ Japan PMDA decision on sNDA for OTEZLA® in Behҫet’s disease

❑ Submit sNDA for OTEZLA® in moderate to severe scalp psoriasis

ABRAXANE®

❑ Ph III apact® data- ABRAXANE® in adjuvant PanC (event-driven) 42

Milestones Expected for Key Pivotal Assets

Ozanimod

❑ Submit NDA to FDA for ozanimod in RMS

❑ Submit MAA to EU for ozanimod in RRMS

❑ Complete enrollment of Ph III TRUE NORTHTM in ulcerative colitis

Fedratinib

❑ FDA decision on NDA for fedratinib in myelofibrosis

❑ Submit EU MAA for Fedratinib in myelofibrosis

❑ Initiate Ph I/II combination trial with luspatercept

Luspatercept

❑ Submit U.S. and EU regulatory applications for MEDALISTTM and BELIEVETM

❑ Ph II myelofibrosis data in H2:2019

Liso-cel

❑ Pivotal TRANSCEND™ data in R/R DLBCL

❑ Submit U.S. BLA in R/R DLBCL

Initiate the pivotal Ph II trial in R/R chronic lymphocytic leukemia (CLL)

bb2121

❑ Pivotal KarMMa™ data in RRMM

❑ Initiate Ph II trial in NDMM

Research & Early Development Pipeline

❑ File at least 5 INDs or CTAs for novel assets

✓

Multiple Myeloma Late-Stage/Pivotal Programs

Patient Population

RRMM RRMM RRMM

Molecule POMALYST®/IMNOVID® bb2121 bb2121

Trial NameMM-007

OPTIMISMM®

BB2121-MM-001

KarMMaTM

BB2121-MM-003

KarMMa-3TM

Phase III II III

Target Enrollment 559 140 381

Design

Arm A: POMALYST®/IMNOVID®

(4mg) + bortezomib (1.3 mg/m2 IV) + low-dose dexamethasone to disease

progression

Arm B: Bortezomib (1.3 mg/m2 IV) + low-dose dexamethasone to disease

progression

bb2121 autologous CAR T cells (infused at a dose ranging from 15 -45 x 107 CAR T cells after receiving

lymphodepleting chemotherapy)

Arm A: bb2121 autologous CAR T cells (infused at a dose ranging from

15 - 45 x 107 CAR T cells after receiving lymphodepleting

chemotherapy)

Arm B: Physicians’ choice

Primary Endpoint Progression Free Survival ORR PFS

Status

Primary endpoint met

Data presented at ASCO 2018

Submitted in EU and Japan

Enrollment complete Not yet enrolling

43

MDS/AML/MF Late-Stage/Pivotal Programs

Patient PopulationLow risk/INT-1 transfusion-

dependent MDSPost induction AML

Maintenance

MoleculeCC-486

(Oral azacitidine)

CC-486

(Oral azacitidine)

Trial Name AZA-MDS-003 CC-486-AML-001

Phase III III

Target Enrollment 216 472

Design

Arm A: CC-486 (300mg daily D1-21 of a 28-D cycle) + best supportive care

Arm B: Placebo + best supportive care

Arm A: CC-486 (300mg D1-14 of 28-D cycle)

Arm B: Best supportive care

Primary EndpointRBC-transfusion independence for

more than 8 weeksOverall Survival

StatusEnrollment complete

Data expected in 2Q2019

Enrollment complete

Data expected in 1H2019 (event driven)

44


Patient PopulationAnemia in to Very Low-, Low-, or

Intermediate-Risk MDSRed Blood Cell Transfusion Dependent

Beta-Thalassemia

Molecule Luspatercept Luspatercept

Trial Name MEDALISTTM BELIEVETM

Phase III III


Design

Arm A: Luspatercept (starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks)

Arm B: Placebo (subcutaneous injection every 3 weeks)

Arm A: Luspatercept (1 mg/kg) + best supportive care

Arm B: Placebo + best supportive care

Primary EndpointRed Blood Cell Transfusion Independence (RBC-TI)

≥ 8 weeks

Proportion of subjects with hematological improvement from Week 13 to Week 24 compared to

12-week prior to randomization

Status


Data presented at ASH 2018

Regulatory submissions planned in H1:19


Data presented at ASH 2018

Regulatory submissions planned in H1:19

45


Patient PopulationESA Naïve Very Low, Low or Intermediate

Risk MDSIDH2 Mutant RR AML

Molecule Luspatercept IDHIFA®

Trial Name COMMANDSTM IDHENTIFYTM

Phase III III


DesignArm A: Luspatercept (1.0 mg/kg SC every 3 weeks)

Arm B: Epoetin alfa (450 IU/kg SC weekly)

Arm A: IDHIFA® (100 mg daily, 28-D cycle) + best supportive care

Arm B: Best supportive care

Primary Endpoint Red blood cell transfusion independence at 24 weeks Overall Survival

Status Trial enrolling Trial enrolling

46

Lymphoma Late-Stage/Pivotal Programs

Patient PopulationRelapsed or Refractory Follicular Lymphoma

Newly Diagnosed Follicular Lymphoma

Untreated Activated B-Cell DLBCL

Molecule REVLIMID® REVLIMID® REVLIMID®

Trial NameAUGMENTTM

NHL-007RELEVANCE®

ROBUST®

DLC-002

Phase III III III

Target Enrollment 358 1,031 570

Design

Arm A: REVLIMID® (10-20mg, D1-21) + rituximab (375 mg/m2 weekly for cycle 1 then D1 of cycles 2-5 for 5 28-D cycles)

Arm B: Placebo (D1-21) + rituximab (375 mg/m2 weekly for cycle 1 then D1

of cycles 2-5 for 5 28-D cycles)

Arm A: REVLIMID® (starting dose 20mg, D2-22 for up to 18 D cycles) + rituximab (starting dose 375 mg/m2

weekly for up to 12 28-D cycles)

Arm B: Physician’s choice of Rituximab-CHOP, Rituximab-CVP or

Rituximab-bendamustine

Arm A: REVLIMID® (15mg, D1-14) + R-CHOP21 (6 21-D cycles)

Arm B: Placebo + R-CHOP21 (6 21-D cycles)

Primary Endpoint Progression Free SurvivalComplete Response Rate and

Progression Free SurvivalProgression Free Survival

Status


Submitted in US & EU

Submission in Japan planned for 1Q2019

Trial did not achieve superiority in co-primary endpoints

Data presented at ASCO 2018

Data expected in 2019 (event driven trial

47


Patient Population Relapsed or Refractory Indolent Lymphoma Relapsed or Refractory B-cell NHL

Molecule REVLIMID®Liso-cel

(lisocabtagene maraleucel; JCAR017)

Trial NameMAGNIFYTM

NHL-008TRANSCEND-NHL-001

Phase III I


Design

Arm A: REVLIMID® (10-20mg, D1-21) + rituximab (375 mg/m2

weekly for cycle 1 then D1 of cycles 3, 5,7,9 and 11 for 12 28-D cycles) followed by REVLIMID® (10mg, D1-21) + rituximab (375 mg/m2 D1 of cycles 13,15,17,19,21,23,25,27 and 29 for 18 28-D

cycles) followed by REVLIMID® (10mg, D1-21 until disease progression, 28 D cycle)

Arm B: REVLIMID® (10-20mg, D1-21) + rituximab (375 mg/m2

weekly for cycle 1 then D1 of cycles 3, 5,7,9 and 11 for 12 28-D cycles) followed by REVLIMID® (10mg, D1-21) + rituximab (375 mg/m2 D1 of cycles 13,15,17,19,21,23,25,27 and 29 for 18 28-D

cycles)

Arm A: JCAR017 single-dose schedule

Arm B: JCAR017 2-dose schedule

Primary Endpoint Progression Free Survival Objective Response Rate; Safety

StatusTrial enrolling

Data expected in 2020

Enrollment complete

Submission expected for 2H:2019

48


Patient PopulationAggressive Relapsed or Refractory B-Cell

LymphomaRelapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

MoleculeLiso-cel


Liso-cel


Trial Name TRANSCEND WORLDTRANSCEND-CLL-004

(017004)

Phase II I/II


DesignArm A: JCAR017 (1 x 108 positive transfected viable T cells

on D 1; 2 to 7 days after completion of lymphodepleting chemotherapy).

Phase I

JCAR017 +/- ibrutinib

Phase II

Experimental: JCAR017 monotherapy at recommended dose (RD)

Active comparator: standard of care

Primary Endpoint Overall Response RatePhase I – Safety and RD of JCAR017 +\- ibrutinib

Phase II – PFS with JCAR017 monotherapy

Status Trial enrolling Enrollment initiated in the Pivotal cohort

49


Patient PopulationAggressive Relapsed or Refractory B-Cell non-

Hodgkin LymphomasRelapsed or Refractory Angioimmunoblastic T

Cell Lymphoma

MoleculeLiso-cel


CC-486

(Oral Azacitidine)

Trial NameTRANSFORM

(JCAR017-BCM-003)OA-CL-LYM-LYSARC-13134

Phase III III


Design

Arm A: standard of care (SOC) per investigator’s decision

Arm B: lymphodepleting chemotherapy followed by JCAR017 infusion

Experimental Arm

Oral azacitidine 200 mg or 300 mg QD x 14 days of 28-day cycle

Control Arm

Investigator’s choice including the following:

Romidepsin: 14 mg/m2 on D 1, 8, and 15 of 28-day cycle

or

Gemcitabine: 1000 mg/m2 on days 1, 8, and 15 of 28-day cycle

Primary Endpoint Event-free Survival (EFS) Progression Free Survival

Status Trial enrolling Trial enrolling50

Solid Tumor Late-Stage/Pivotal Programs

Patient PopulationAdjuvant Therapy in Surgically

Resected Pancreatic CancerNewly Diagnosed Glioblastoma

Newly Diagnosed Stage III non-Small Cell Lung Cancer

Molecule ABRAXANE® Marizomib Tislelizumab (BGB-A317)

Trial NamePANC-003

apact®EORTC-BTG-1709

BGB-A317-NSCL-001

RATIONALE001

Phase III III III


Design

Arm A: ABRAXANE® (125 mg/m2); Gemcitabine (1000 mg/m2) D1,8,15 for 6

28-D cycles

Arm B: Gemcitabine (1000 mg/m2) D1,8,15 for 6 28-D cycles

Arm A: Radiotherapy + temozolomide + marizomib followed by adjuvant

temozolomide + marizomib

Arm B: Radiotherapy + temozolomide followed by adjuvant temozolomide

Arm 1: tislelizumab + concurrent chemoradiotherapy (cCRT) followed by

tislelizumab monotherapy

Arm 2: placebo + cCRT followed by tislelizumab monotherapy

Arm 3: placebo + cCRT followed by placebo monotherapy

Primary Endpoint Disease Free Survival Overall Survival Progression Free Survival

StatusEnrollment complete

Data expected in 2019 (event driven)Trial enrolling Trial enrolling

51

I&I Late-Stage/Pivotal Programs

Patient Population Active Behçet’s Disease Scalp PsoriasisMild to Moderate Plaque

Psoriasis

Molecule OTEZLA® OTEZLA® OTEZLA®

Trial NameBCT-002

RELIEF®

SPSO-001

STYLETM

PSOR-022

ADVANCETM

Phase III III III


Design

Arm A: Placebo (for 12 weeks) followed by OTEZLA® (30mg twice daily for 52

weeks)

Arm B: OTEZLA® (30mg twice daily for 64 weeks)

Arm A: Placebo (for 16 weeks) followed by OTEZLA® (30mg twice daily for 16

weeks)

Arm B: Placebo (for 32 weeks)

Arm A: OTEZLA® 30 mg BID for 16 weeks

Arm B: Placebo BID for 16 weeks

Primary EndpointArea under the curve (AUC) for the number of oral ulcers from baseline

through week 12

Proportion of subjects with ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from

baseline at Week 16

Proportion of subjects with an sPGAscore of clear (0) or almost clear (1) and

with at least a 2- point reduction from baseline at Week 16.

Status

Met primary endpoint

Data presented at AAD 2018

sNDA submitted; Additional regulatory submissions planned

Met primary endpoint Trial not yet enrolling

52

I&I Late Stage Programs

Patient PopulationModerate to Severe Ulcerative

ColitisModerately to Severely Active

Crohn's DiseaseModerately to Severely Active

Crohn's Disease

Molecule Ozanimod Ozanimod Ozanimod

Trial Name TRUE NORTHTM RPC01-3201 RPC01-3202

Phase III III III


Design

Arm A: Ozanimod (1mg daily) for induction and maintenance

Arm B: Placebo induction and maintenance

Arm A: Ozanimod (0.92 mg daily) with a 7-D dose escalation

Arm B: Placebo

Arm A: Ozanimod (0.92 mg daily) with a 7-D dose escalation

Arm B: Placebo

Primary Endpoint

Clinical remission assessed by Mayo component sub-scores at week 10

Clinical remission assessed by Mayo component sub-scores at week 52

Proportion of subjects with a CDAI score < 150 at Week 12

Proportion of subjects with a CDAI score < 150 at Week 12

StatusEnrollment expected to complete by

mid-2019Trial enrolling Trial enrolling

53

I&I Late Stage Programs

Patient Population

Maintenance for Moderately to Severely Active Crohn's Disease

Relapsing Multiple Sclerosis Relapsing Multiple Sclerosis

Molecule Ozanimod Ozanimod Ozanimod

Trial Name RPC01-3203 SUNBEAMTM RADIANCETM

Phase III III III

Target Enrollment 485 ~1,300 ~1,300

Design

Arm A: Ozanimod (0.92 mg daily for 40 weeks)

Arm B: Placebo (daily for 40 weeks)

Arm A: Ozanimod (0.5mg daily) + placebo IM weekly

Arm B: Ozanimod (1mg daily) + placebo IM weekly

Arm C: Placebo (daily) + beta-interferon IM weekly

Arm A: Ozanimod (0.5mg daily) + placebo IM weekly

Arm B: Ozanimod (1mg daily) + placebo IM weekly

Arm C: Placebo (daily) + beta-interferon IM weekly

Primary Endpoint

Proportion of subjects with a CDAI score of < 150 at week 40

Proportion of subjects with a (SES-CD) score decrease from baseline of ≥ 50% at week 40

Annualized relapse rate at month 12 Annualized relapse rate at month 24

Status Trial not yet enrolling

Data presented at ECTRIMS 2017 and AAN 2018

NDA expected to be resubmitted in Q1:19; MAA expected to be submitted in

Q1:19

Data presented at ECTRIMS 2017 and AAN 2018

NDA expected to be resubmitted in Q1:19; MAA expected to be submitted in Q1:19

54

q4 and full year 2018 conference call...q4:18 conference call mark alles, chairman & chief...

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