Pharmaceutical Business Review

31
Jessica Riley, Shells Artwork from Reflections Art in Health Pharmaceutical Business Review September 13, 2018

Transcript of Pharmaceutical Business Review

Page 1: Pharmaceutical Business Review

Jessica Riley, ShellsArtwork from Reflections Art in Health

Pharmaceutical Business Review

September 13, 2018

Page 2: Pharmaceutical Business Review

Welcome and Introductions

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Mathai Mammen, M.D., Ph.D.Global Head, Janssen Research & Development

Joaquin DuatoVice Chairman of the Executive Committee

Johnson & Johnson

Jennifer TaubertExecutive Vice President,

Worldwide Chairman, Pharmaceuticals

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Today’s Agenda

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Welcome and Introductions Lesley Fishman

Global Pharmaceutical Overview Joaquin Duato

Our Strategy for Delivering Growth• Pipeline Progress and Growth Drivers

• Deep Dive: Immunology and Oncology Portfolios

• Other Key Portfolio/Pipeline Opportunities

Jennifer TaubertMathai Mammen

Q&A All

Closing Remarks Jennifer Taubert

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Cautionary Note on Forward-Looking Statements

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This presentation contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other

things: future operating and financial performance, product development, market position and business strategy. The viewer is cautioned not to rely on

these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or

known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.

Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition,

including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development,

including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products;

challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans;

the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or

safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability

claims; changes to applicable laws, regulations and government policies, including tax laws and global health care reforms; trends toward health care

cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international

economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; and the potential failure to

meet obligations in compliance agreements with government bodies. A further list and descriptions of these risks, uncertainties and other factors can be

found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned

“Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Reports on

Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at

www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this presentation speaks only as of the date

of this presentation. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or

developments.

Cautionary Note on Non-GAAP Financial MeasuresThis presentation refers to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and

should be read together with, the most comparable GAAP financial measures.

A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying

financial schedules of the Company’s most recent earnings release of July 17,2018 and the Investor Relations section of the Company’s website at

www.investor.jnj.com.

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Cardiovascular &Metabolism/Other

INVOKANA® / INVOKAMET® / VOKANAMET® / INVOKAMET® XR fixed-dose combination licensed from Mitsubishi Tanabe Pharma Corporation; XARELTO®

co-developed with Bayer HealthCare AG; and PROCRIT®/EPREX® licensed from Amgen Inc.

Immunology REMICADE® and SIMPONI® / SIMPONI ARIA® marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi Tanabe Pharma Corporation; TREMFYA® discovered using MorphoSys AG antibody technology; and JNJ-4500 (NKG2D) licensed from Novo Nordisk

Infectious Diseases & Vaccines

PREZCOBIX® / REZOLSTA® fixed-dose combination, SYMTUZA™ and ODEFSEY® developed in collaboration with Gilead Sciences, Inc.; JULUCA® developed in collaboration with ViiV Healthcare UK; and pimodivir licensed from Vertex Pharmaceuticals, Inc.

Neuroscience INVEGA SUSTENNA® / XEPLION® / INVEGA TRINZA® / TREVICTA® includes technology licensed from Alkermes Pharma Ireland Limited

Oncology

IMBRUVICA® developed in collaboration and co-marketed in the U.S. with Pharmacyclics, LLC, an AbbVie company; ZYTIGA® licensed from BTG International Ltd.; VELCADE® developed in collaboration with Millennium: The Takeda Oncology Company; DARZALEX® licensed from Genmab A/S; erdafitinibdiscovered in collaboration with Astex Pharmaceuticals, Inc.; imetelstat licensed from Geron Corporation; niraparib licensed from TESARO, Inc.; JNJ-4528 BCMA CAR-T Therapy licensed and developed in collaboration with Legend Biotech USA Inc., Legend Biotech Ireland Limited (“Legend”), subsidiaries of GenScriptBiotech Corporation

Pulmonary Hypertension

UPTRAVI® worldwide (except for Japan) license and supply agreement with Nippon Shinyaku (co-promotion in Japan) and OPSUMIT® co-promotion agreement with Nippon Shinyaku in Japan

Strategic Partnerships, Collaborations and Licensing ArrangementsDuring the course of this presentation, we will discuss a number of products and compounds developed in collaboration with strategic partners or licensed from other companies. Following is an acknowledgement of those relationships:

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Michelle Hammer, SilenceMichelle Hammer is a NYC native with Schizophrenia.

Global Pharmaceutical Overview

Vice Chairman of the Executive Committee

Johnson & Johnson

Joaquin Duato

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Global Pharmaceutical Market Continues to Be Attractive and Dynamic

Pharmaceutical market value by 2021

$1.4T

Source: IQVIA

Estimated branded market growth 2017-2021

~5%

Source: IQVIA

• Rising cost of health care is straining budgets of public and private payers

• Innovators are capturing a shrinking proportion of spending on drugs

• Uncertainty of pricing policy proposals

• Competition from biosimilars is accelerating

• Global aging population increasing demand for health care

• New disease insights offer opportunity to address unmet needs

• New modalities such as cell and gene therapy can be transformational

• Machine Learning and AI will affect cost, speed and probability in R&D

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Health Care Trends

Other Market Dynamics

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Our Business Model Positions Us for Sustainable Success

Focused Therapeutic Areas6

14Approximate historical split between internal and external sources of growth

50/50Invested in R&D (2017)

$8.4B

Deep Scientific Expertise

Prioritized R&D Investment

World-Class Commercial Capabilities

R&D Programs

350+

Note: Internal data, 2017

New products* approved since 2011; industry leader in $1B+ brands**

*Excludes OPSUMIT® and UPTRAVI®

**EvaluatePharma CY 2017 Sales 8

(2017–1H 2018)

100%Operational Growth from Volume

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Our Growth Is Double That of the Pharm Industry ― Driven by Strong Brands

7Consecutive years of operational sales growth

Global Branded MarketJanssen

Sale

s C

AG

R (

20

10

-20

17

)

8.6%

4.3%

9Sources: Internal data (Janssen Growth ex-Actelion was 8.0%)

IQVIA MIDAS sales data for Innovative Branded Products

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Delivering Above-Market Growth Through 2021

101. Peak non-risk adjusted sales, including partner sales

14Blockbusters, Majority with

Share Growth and Line Extension Opportunities

Up to

10Anticipated $1B+ Launches

&/or Filings 2017-20211

Sixth Therapeutic Area:Pulmonary Hypertension

Blockbuster Portfolio

Industry-Leading, Late-Stage Pipeline

Additional Growth Driver

Actelion

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Martin Freeman, UntitledDiagnosed with AIDS in 1990, Martin lives in San Francisco where he continues to create new pieces.

Our Strategy for Delivering Growth

Pipeline Progress and Growth Drivers

Jennifer Taubert

Worldwide Chairman, Pharmaceuticals

Mathai Mammen, M.D., Ph.D.

Global Head, Janssen R&D

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Since Our Last Pharmaceutical Business ReviewOur business remains strong, with volume gains driving growth across our market-leading brands

We remain confident we can continue to deliver above-market growth through 2021 in the face of challenging market dynamics

• Successfully launched TREMFYA® and ERLEADA®

• Twelve recent approvals including new indications for DARZALEX®, IMBRUVICA®, ZYTIGA®, SIMPONI ARIA®, JULUCA® and SYMTUZA™

• Filed esketamine in US (September); anticipate filing in EU in Q4

• On track to file erdafitinib (US) in Q3

• Successfully integrated Actelion with its Pulmonary Hypertension portfolio

• Strong operational sales growth and share gains

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Continued Uptake and New Indications Driving Above-Market Growth Through 20211

Fueled by share gains and expected 50+ line extensions, 10+ with $500M+ potential

131. Non-risk adjusted projected sales, including partner sales

Blockbuster Portfolio

Blockbusters$1B+ Brands1

Mega-Blockbusters$4B+ Brands1

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ONCOLOGY

Front-Line Multiple Myeloma (Non-Transplant) VMP Approved

Front-Line Multiple Myeloma (Non-Transplant) Rd 2019

Front-Line Multiple Myeloma (Transplant) 2019

Subcutaneous Rapid Administration 2019

CLL Front-Line Combo with Obinutuzumab Filed

CLL Front-Line Combo with Rituximab 2020

Front-Line Maintenance Mantle Cell Lymphoma 2020

Follicular Lymphoma Relapsed/Refractory 2020

Front-Line CLL (IV Fixed Duration) 2021

Chemo-Naïve Prostate Cancer (ZYTIGA® Combo) 2019

Hormone-Naïve Prostate Cancer 2019

Localized Prostate Cancer 2021

INFECTIOUS DISEASES & VACCINES

Darunavir STR for HIV Approved

Rilpivirine/Dolutegravir STR for HIV Approved

Rilpivirine Long-Acting Maintenance

HIV (Injectable) 2019

Major Line Extensions Potential Approvals and Filings 2017-20211

1. Filings/approvals are in the US or EU, unless otherwise noted. All dates represent first filing dates.This information is accurate as of September 13, 2018 to the best of Johnson & Johnson’s knowledge. The Company assumes no obligation to update this information.

CARDIOVASCULAR & METABOLISM

Coronary Artery Disease/Peripheral Artery Disease Filed

VTE Prevention Medically-Ill Patients 2019

Cardiovascular OutcomesApproved

(EU)

Diabetic Kidney Disease 2019

PULMONARY HYPERTENSION

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Filed

Fontan-Palliated 2020

Pulmonary Arterial Hypertension IV 2019

IMMUNOLOGY

Ulcerative Colitis 2018

Psoriatic Arthritis 2019

NEUROSCIENCE

Paliperidone palmitate 6-month long-acting

Maintenance Treatment of Schizophrenia(Injectable)

2020

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Select Next Wave of Innovation

+ Major New Indications

Recent Launches

Non-metastatic CRPC

Psoriasis

2019-2021 Potential Filings

BCMA CAR-TMultiple Myeloma

imetelstatMyelofibrosis

lumicitabine*RSV Infection

niraparibProstate Cancer

pimodivirInfluenza A

ponesimodRelapsing Multiple Sclerosis

• Curative Hepatitis B Regimens

• T-Cell Redirection

• Glutamatergic Transmission

• Immune Checkpoint Modulation

• Oncolytic Immunotherapy Platform

• Locally-Directed Therapies for IBD

• Factor XIa Inhibition

• Immunometabolism Modulation

2018 Filings

esketamineTreatment-Resistant Depression

erdafitinibUrothelial Cancer

A Pipeline of Differentiated NMEs and Emerging Science Driving Patient Impact

In-Market Blockbuster

Portfolio

15*On clinical hold. Development timeline under review.

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STELARA®: Unique Mechanism of Action Redefining Treatment in PsO, PsA and CDNow Janssen’s Largest Product

RE

PO

RT

ED

NT

S (

$M

)

20162015201420132012 2017

Source: As reported, worldwide net trade sales, indication splits are internal estimates

1,026

1,508

2,072

2,474

3,232

4,011

2,402

1H ‘18

CD

PsO/PsA

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STELARA® CD Indication Is Contributing to Solid Growth

Drivers of Current Success

• Large unmet medical need in Crohn’s disease (CD)

• As the only IL-12/23, STELARA® demonstrates highly-competitive efficacy and durability of remission in CD patients

• Strong uptake in CD with WW sales approaching $1B+

• Consistent performance in large PsO/PsA markets continues to provide a significant, solid base business

Opportunities for Growth

• STELARA® CD — ongoing trials to demonstrate expanded clinical utility, including:

H2H vs. Humira — biologic-naïve patients with moderately-to-severely active CD

• STELARA® UC — Phase 3; anticipated filings in US, Canada, EU and Japan by end of Q1 2019

• STELARA® lupus — Phase 3

IMMUNOLOGY

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TREMFYA®: Novel First-in-Class Anti-IL-23 Ongoing PsO Launch Success; Investments in New Indicationsto Drive Growth

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TREMFYA® Launch Exceeding Expectations

WW Sales USD ($MM)

Source: As reported, net trade sales

$16

$47

$72

$126

$50

$0

$100

$150

Q4 2017 Q2 2018Q1 2018

$MM

Q3 2017

Drivers of Current Success

• First and only anti-IL-23 approved for PsO

Superior efficacy with comparative data against two different mechanisms (H2H vs. Humira and H2H vs. STELARA®

inadequate responders)

Therapeutic longevity with sustained efficacy up to three years

• Launch exceeding expectations with strong demand

Rapid uptake by dermatologists demonstrates highly-competitive product profile vs. anti-IL-17s

New-to-brand share in US outpacing anti-IL-17s*

Launch-aligned, new-to-brand share performance exceeding previous IL-17 launches*

Opportunities for Growth

• ECLIPSE: H2H study vs. secukinumab in PsO (PASI 90, PASI 100 comparison at Week 48)

• Phase 3 for PsA under way

• Phase 2b/3 for CD under way

• IL-23 pathway opens opportunities to treat new diseases

IMMUNOLOGY

*Source: IQVIA Patient Claims including PsO Simple Trial Program

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APPROVED PRODUCTSPRODUCTS APPROVED/FILED

AND PLANNED FILINGS 2017-2021 SELECT NEW PLATFORMS & DISEASE FOCUS

APPROVED

PLANNED FILINGS

STELARA®

• Ulcerative colitis

• Pediatric (6-11 yr) psoriasis

• Systemic lupus erythematosus

TREMFYA®

• Psoriatic arthritis

• Crohn’s disease1

SIMPONI ARIA® (intravenous)

• Juvenile idiopathic arthritis (US)

TREMFYA®

• Psoriasis

STELARA®

• Adolescent psoriasis (US)

SIMPONI ARIA® (intravenous)

• Psoriatic arthritis (US)

• Ankylosing spondylitis (US)

1. Anticipated filing in 2022

Note: Filings/approvals are in the US or EU, unless otherwise noted. This information is accurate as of September 13, 2018to the best of Johnson & Johnson’s knowledge. The Company assumes no obligation to update this information.

Line ExtensionsNew Molecular Entities

Gastroenterology• Novel biologic targets (e.g., NKG2D) • Microbiome• Orally-delivered, GI-localized therapies

and in combination• Anti-sense oligonucleotide therapy• Biologic combination therapy

Rheumatology• RA Bone protection• Sjögren’s syndrome• Lupus nephritis

Other• Type 1 diabetes stages 2 & 3• Hidradenitis suppurativa

Immunology: Advancing Our Leadership Position Through 2021 and Beyond

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ERLEADA®: Redefining Prostate Cancer TreatmentTreating Patients Earlier to Improve Outcomes

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2. US, Canada, Australia, Brazil, Taiwan, Turkey

1. Decision Resources: Prostate Cancer Landscape and Forecast, 2016 (G7 estimates)

Castration-resistantLINE 1

75K pts

Metastatic

Hormone-sensitive 35K pts

APPROVED1st APPROVAL2

Prevent/Treat Emerging Resistance

Non-Metastatic

Localized disease 600K pts1

+

Biochemical recurrence 100K pts

Castration-resistant 70K pts

Castration-resistantLINE 2

60K pts

Castration-resistantLINE 2+ 45K pts

Focus on Early Disease (CURES)

Expanding Janssen’s Leadership in Prostate CancerTreatment Across Continuum of Care

Drivers of Current Success

• Approved by US FDA — first novel oral agent in non-metastatic disease (nmCRPC), largest segment of population

Proven efficacy providing 40.5 months of metastatic-free survival (vs. 16.2 months for placebo)

Robust SPARTAN data package, NEJM publication and positive NCCN/AUA guidelines

• Strong uptake in US with urologists — payer access currently above 80%

Opportunities for Growth

• Expected EU approval in Q1 2019 for nmCRPC

• Broad-based approach to prostate cancer, with intent of creating a new foundational therapy

Localized prostate cancer (ATLAS); filing expected 2021

Hormone-sensitive prostate cancer (TITAN); filing expected 2019

ERLEADA® plus ADT + ZYTIGA® plus prednisone (ACIS): chemo-näive mCRPC; filing expected 2019

ONCOLOGY

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IMBRUVICA®: Expanding Market LeadershipEight Potential New Filings to Drive Growth

20

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

IMBRUVICA R3M Rituxan Benda +/- R Chlor +/- R

R CHOP Fluda +/- Others Others Idela

Obin +/- chlor Venetoclax Calquence Lena +/- R

Drivers of Current Success

• First BTK inhibitor with proven efficacy and safety profile across nine US indications

>120,000 patients treated WW since launch

Approved in 92 countries

Best-in-class market access

Approvals for both monotherapy and combination therapies

• Leadership in CLL (L1 & L2+), Waldenström’smacroglobulinemia (WM) (L2+) and MCL (L2+) in US new patient share

Opportunities for Growth

• Eight potential new filings ahead; five with $500M+ potential

• New registrations could access >40,000 additional patients annually in US alone

Ibrutinib + rituximab approved in WM in US

US submission of IMBRUVICA® + obinutuzumab in L1 CLL filed

Q3 2018

Exploring new innovative combinations in L1 CLL

▪ ibrutinib + venetoclax

Leader in CLL L2+ New Patient Share

ONCOLOGY

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WW Launch-Aligned Sales Exceeding Multiple Myeloma Analogs

DARZALEX®: Reshaping Treatment of Multiple MyelomaFront-Line Indications and SubQ Rapid Administration to Drive Future Growth

0

50

100

150

200

250

300

350

400

450

500

550

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DARZALEX®

POMALYST®

EMPLICITI®

KYPROLIS®

REVLIMID®

NINLARO®

VELCADE®

Q3 Q7Q0 Q1 Q5Q2 Q4 Q6 Q8 Q9 Q10 Q11

Drivers of Current Success

• First and only anti-CD38 approved for multiple myeloma; approved in 70+ countries

• Five indications approved WW from late-stage to front-line, with two BT designations

Approval as single agent and in combination regimens

Front-line indication approved Q2 2018 in US; Q3 2018 in EU

>50,000 patients treated WW since launch

Opportunities for Growth

• Clinical data presentations in front-line multiple myeloma

− ALCYONE: non-transplant population (approved)

− MAIA: non-transplant population

− CASSIOPEIA: transplant-eligible population

− Additional front-line studies in combination with VRd

• Split-dose administration submitted Q3 2018

• SubQ rapid administration in Phase 3; anticipated filing 2H 2019

• Broad clinical development plan with 14 registration studies under way, including potential new indications such as smoldering myeloma, AL amyloidosis, etc.

USD ($M)

ONCOLOGY

Source: EvaluatePharma

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Our Approach to Immuno-Oncology

Directed T-Cell Therapies

CAR-T

T-Cell Redirection

Antigen Presentation/Priming Combinations

With Checkpoint

Oncolytic Viruses

Vaccine

CD40 Agonist, STING Agonist, TLR9 Agonist

Costimulators

T-Cell Checkpoint Inhibitors

Myeloid Cells

Immune-Suppressive Cell Modulation

1 2 3

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CAR-T Cell TherapyGroundbreaking Immunotherapy Platform for the Treatment of Cancer

• Foundational to our strategy in immuno-oncology

• Creates a specific, potent and durable anti-tumor T-Cell response in patients

• Potential for exceptional potency and curative responses across tumor types

• Single dose can drive potent and long-lasting activity; “living drug”

• Lead program, LCAR B38M (BCMA), IND open and study now enrolling in US

• Multiple additional programs under development in hematologic malignancy and solid tumors

• Ongoing build of commercial manufacturing capabilities

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APPROVED PRODUCTSPRODUCTS APPROVED/FILED

OR PLANNED FILINGS 2017-2021 EARLY-STAGE FOCUS AREAS

AND PLATFORMS

IMBRUVICA®

• cGVHD R/R (US)^

• Marginal zone lymphoma^

• Waldenström’smacroglobulinemia combo^

• CLL front-line combo with obinutuzumab*

DARZALEX®

• Front-line MM (non-transplant) Rd

• Front-line MM (transplant)

• Subcutaneous Rapid Administration

• Amyloidosis

• MDS low/intermediate risk

• MM R/R combo with Car/Dex

IMBRUVICA®

• CLL front-line combo with rituximab

• CLL watch and wait

• MCL front-line maintenance

• MCL R/R combo with venetoclax

• Follicular lymphoma R/R

• DLBCL front-line combination

• GVHD front-line

• Front-line CLL (IV fixed duration)

imetelstat• Myelofibrosis

• Myelodysplastic syndrome low/intermediate risk

ERLEADA®

• Chemo-naïve PC (+ ZYTIGA®)

• Hormone-naïve PC

• Localized PC

• ERLEADA® fixed-dose combo

niraparib• metastatic castration-resistant PC

• mCRPC combination

• Metastatic hormone-sensitive prostate cancer combination

erdafitinib (FGFR inhibitor)• Urothelial cancer

JNJ-4528 (BCMA CAR-T)• Multiple myeloma

DARZALEX®

• R/R MM (EU)^

• MM R/R combo with PomDex (US)^

• Front-line MM (non-transplant) VMP^

ZYTIGA®

• Hormone-naïve metastatic PC^

ERLEADA®

• Non-metastatic prostate cancer^

Oncology Pipeline: Building and Sustaining Our Leadership Position Through 2021 and Beyond

(OUS)

(EU)

(US)

(OUS)

(OUS)

P L A N N E D F I L I N G S 1

A P P R O V E D / F I L E D

Line ExtensionsNew Molecular Entities

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(US)

Oncogenic Drivers

• EGFR/cMET

• PRMT5

• KRAS

Directed T-Cell Therapies

• CAR-Ts

• xCD3 bi-specific

Comprehensive Regimens for Immune Therapy

• Oncolytic virus

• Antigen presentation/pPriming

• Vaccines

• Checkpoint/Agonist combinations

^Approved; *In Registration1. Does not include registrations where Janssen is not the study sponsor. This information is accurate as of September 13, 2018 to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information. Note: Filings/approvals assumed to be in US, EU unless otherwise noted.

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Drivers of Current Success

• Global leader in pulmonary arterial hypertension (PAH) with treatments across continuum of disease

• OPSUMIT® achieved blockbuster status in 2017, less than four years after launch

• OPSUMIT® and UPTRAVI® benefitting from regulatory approvals and market access capabilities globally

Opportunities for Growth

• OPSUMIT® potential new indications:

CTEPH ― a near-term significant opportunity; filed with FDA in

April 2018 and EMA in August 2018

Fontan-palliated; Phase 3

• UPTRAVI® growth from earlier use and combination therapy

• Developing improved diagnostics to reduce current 2.5 year gap between disease onset and physician diagnosis

• Fixed-dose combination products advancing in clinic

• Triple-therapy study under way: TRITON (with OPSUMIT®, UPTRAVI® and tadalafil)

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1H ‘18

OPSUMIT® UPTRAVI®

OPSUMIT® and UPTRAVI®: Delivering Value and GrowthCTEPH Offers Substantial Opportunity

PULMONARYHYPERTENSION

OPSUMIT® and UPTRAVI® Sales Since Launch

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Esketamine: First New MOA in Major Depressive Disorder (MDD) in 30 YearsTransformational Investigational Therapy for Treatment-Resistant Depression (TRD) and for MDD Patients at Imminent Risk for Suicide

Key Highlights

• TRD is a hard-to-treat population, with high unmet need: ~30% of drug-treated patients with MDD have TRD and do not respond to existing therapies

• Novel mechanism of action: glutamate receptor modulation thought to help restore neuronal connections in patients with MDD

• Comprehensive global clinical program demonstrates superiority vs. standard of care (oral AD) in MDD

Five Phase 3 studies in TRD, with acute and long-term maintenance

data available at launch

Data show rapid reduction of symptoms

Long-term efficacy established in relapse prevention study (3003)

• US filing Sept. 2018; EU filing anticipated Oct. 2018

Future Opportunities

• MDD with imminent risk for suicide in Phase 3; US and EU filing anticipated 2020

• Glutamate pathway offers opportunities for other neuropsychiatric disorders

-25

-20

-15

-10

-5

0

Antidepressant +…

Day 28Day 22Day 15Day 8Day 2(24 hrs)

Baseline

LE M

ean

Ch

an

ge in

MA

DR

S T

ota

l S

core

Placebo + Antidepressant (n=109)Esketamine + Antidepressant (n=114)

Time (Days)

-4.0(1-sided

P < 0.010)

MADRS LS Mean Difference at Day 28

Least Squares (LS) Mean Change (± SE) from Baseline in MADRS Total Score Over Time

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NEUROSCIENCE

Clinically-meaningful and statistically-significant improvement in depressive symptoms (MADRS Score) vs. Oral AD + placebo*

69.3% response rate

52.5% remission rate

*

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Evolving Our R&D Strategy to Embrace Future Drivers of Innovation

Accelerating Use of Data Sciences

in R&D

Building New Disease and Pathway Area

Strongholds

Investing in New Platforms and

Critical Talent

1 2 3

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Delivering Transformational Medical Innovation to Drive Long-Term Growth

• Deep scientific expertise and world-class commercial capabilities

• Robust, differentiated pipeline generating near- and long-term growth

• Potential for significant new product filings and/or launches ($1B+ in revenue) and >50 potential new line extensions

• Industry-leading internal and external innovation

• Proven business model continues to deliver strong performance with above-market growth

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Pharm company based on $1B+ products*#1Globally in branded market net trade sales for 2017*#4

Well-positioned for continued above-market compound annual growth through 2021

*EvaluatePharma 2017

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See you at our

next full-day

Pharmaceutical

Business Review

in May 2019!

Details to be provided

Page 31: Pharmaceutical Business Review