The document is an agenda for an investor presentation. It outlines the schedule for the day which includes presentations on the company's enterprise overview, pharmaceutical commercial and R&D strategies, and various therapeutic areas. It also includes notices about forward-looking statements and new molecular entities being discussed. The speakers and locations are listed next to each topic.
3. Agenda
TIME TOPIC SPEAKER/LOCATION
8:30 a.m. Introductions / Overview of Day Louise Mehrotra
Enterprise Overview Dominic Caruso
Pharmaceutical Commercial Overview Joaquin Duato
Pharmaceutical R&D Strategy William Hait, M.D., Ph.D.
Immunology Susan Dillon, Ph.D.
Infectious Disease Lawrence Blatt, Ph.D., M.B.A.
10:40 a.m. Break Atrium
Q&A Panel
Neuroscience Husseini Manji, Ph.D., F.R.C.P.C.
11:50 p.m. Lunch / Booth Displays Atrium
12:50 p.m. Cardiovascular/Metabolism James List, M.D., Ph.D.
Oncology Peter Lebowitz, M.D., Ph.D.
Creating Value Through Innovation Paul Stoffels, M.D.
Q&A Panel
2:40 p.m. Conclusion Louise Mehrotra
4. Notice Regarding Forward-Looking Statements
These presentations contain “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 the Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in new product
development, including uncertainty of clinical success and decisions of regulatory authorities regarding approval, labeling and other
matters that could affect the availability or commercial potential of product candidates; uncertainty of commercial success for new
and existing products; the ability of the company to successfully execute strategic plans; challenges to patents; the impact of patent
expirations; impact of business combinations and divestitures; competition, including technological advances, new products and
patents attained by competitors; future clinical data and analysis, including post marketing surveillance; economic factors, such as
interest rate and currency exchange rate fluctuations; changes to applicable laws and regulations, including global health care
reforms; trends toward health care cost containment; changes in behavior and spending patterns or financial distress of purchasers
of health care products and services; product efficacy or safety concerns resulting in product recalls or regulatory action; significant
adverse litigation or government action; and increased scrutiny of the health care industry by government agencies. A further list
and description 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 28, 2014, including Exhibit 99 thereto, and the company’s subsequent filings with the Securities and
Exchange Commission. Copies of these filings are available online at www.sec.gov, www,investor.jnj.com, or on request from
Johnson & Johnson. Any forward-looking statement made in these presentations speak only as of the date of these presentations.
The Janssen Pharmaceutical Companies and Johnson & Johnson do not undertake to update any forward-looking statements as a
result of new information or future events or developments.
5. New Molecular Entities
These presentations contain statements about new molecular entities (“NMEs”) and other
medicines or line extensions in various stages of development. These statements are
based on the Company’s current knowledge of the status of development of these NMEs,
medicines and line extensions and are subject to the challenges and difficulties inherent in
product development. The Company assumes no obligation to update any statements
regarding these NMEs, medicines or line extensions as a result of new information or
future events or developments.
In addition, in biopharmaceuticals, there are considerable possibilities of encountering
infringement claims by competitors with respect to patents or other intellectual property
rights.
6. Note: Operational sales growth excludes the effect of translational currency.
Notice Regarding Non-GAAP Statements
Notice Regarding Third-Party Trademarks
Third-party trademarks used herein are trademarks of their respective owners.
This 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 on the Investor Relations
section of the Company’s website at www.investor.jnj.com.
7. During the course of this morning’s presentations, 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.
Strategic Partnerships, Collaborations
and Licensing Arrangements
Immunology REMICADE
®
and SIMPONI
®
marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi Tanabe Pharma
Corporation, Sirukumab developed in collaboration with GlaxoSmithKline, VE 202 licensed from Vedanta Biosciences, Inc., CNTO 9762 includes technology
licensed from Genmab A/S, and NNC-0142-002 licensed from Novo Nordisk, A/S.
Neuroscience INVEGA
®
SUSTENNA
®
/XEPLION
®
includes technology licensed from Alkermes, Inc., Bapineuzumab was being developed through a collaboration between
Janssen Alzheimer Immunotherapy (now Janssen Sciences Ireland) and Pfizer, Inc., Inhibitor–Prodromal Alzheimer’s disease licensed from Shionogi & Co.,
AAB-003 developed in collaboration with Pfizer, ULTRAM
®
ER licensed from Grunenthal GmbH, AXERT
®
licensed from Almirall Prodesfarma, Point-of-Care
Diagnostic developed in collaboration with Royal Philips, Anti-Tau vaccine developed in collaboration with AC Immune SA, Alpha-2C AR antagonist licensed
from Orion Corporation, JNJ-922 (Orexin-2 antagonist) developed in collaboration with Minerva Neurosciences, Inc.
Infectious
Diseases &
Virology
INCIVO
®
developed in collaboration with Vertex Pharmaceuticals, OLYSIO
®
developed in collaboration with Medivir AB, PREZCOBIXTM/ REZOLSTATM fixed-
dose combination and Rilpivirine +F/TAF FDC developed in collaboration with Gilead Sciences, Inc., Rilpivirine + dolutegravir FDC in collaboration with ViiV
Healthcare UK, HIV Vaccine developed in collaboration with Beth Israel Deaconess Medical Center and National Institutues of Health, (NIH), JNJ-872 (VX-787)
licensed from Vertex, Pharmaceuticals, Inc., Expec 4v Conjugate licensed and in collaboration with GlycoVaxyn AG.
Cardiovascular/
Metabolism
INVOKANA
®
and INVOKAMET
®
/VOKANAMET
®
fixed-dose combination licensed from Mitsubishi Tanabe Pharma Corporation, XARELTO
®
co-developed with
Bayer HealthCare AG.
Oncology IMBRUVICA
®
developed in collaboration and co-marketed with Pharmacyclics, Inc., ZYTIGA
®
licensed from BTG International Ltd., VELCADE
®
developed in
collaboration with Millennium: The Takeda Oncology Company, DACOGEN
®
developed in collaboration with Eisai Corporation of North America, Daratumumab
developed in collaboration with Genmab A/S, YONDELIS
®
developed in collaboration with Pharma Mar S.A., PROCRIT
®
/EPREX
®
licensed from Amgen Inc .,
FGFR Inhibitor licensed from Astex Pharmaceuticals, Inc., Imetelstat licensed from Geron Coporation, MDG011 licensed from Macrogenics, Inc., CSL362
licensed from CSL Limited, JNJ-809, JNJ-757, and ADU741 licensed from Aduro Biotech, Inc., RIBOMUSTIN
®
licensed from Astellas, Inc.
8. During the course of this morning’s presentations, 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.
Strategic Partnerships and Other Acknowledgments
Global Public
Health
Monovalent Ebola Vaccine is developed in collaboration with Bavarian Nordic A/S and has received direct funding and preclinical services
from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C,
and HHSN272201000006I and HHSN272201200003I, respectively. This program is also receiving funding from the IMI2 Joint Undertaking
under EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This IMI2
Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and the European
Federation of Pharmaceutical Industries and Associations. MVA-BN licensed from Bavarian Nordic A/S.
12. 12
Global Health Care Environment
Four Imperatives to Global Health Care
Focusing on Wellness & Prevention
Expanding Access Rewarding Innovation
Integrating Care
13. 13
31 53Consecutive
years of
dividend
increases
AAA of sales from
#1 or #2 global
market share
position
of sales from
products launched
in past 5 years
Consecutive
years of adjusted
earnings
increases1
of 10 year Free
Cash Flow
returned to
shareholders
~70% ~25%
~70%
Largest and Most Diversified Health Care
Company in the World
Rated Balance Sheet
Operational and investment
flexibility
1. Non-GAAP measure; excludes special items.
14. 14
Significant Advantages from Our Broad-Based
Health Care Focus
Diverse Portfolio
• Meeting demands of evolving health care industry
• Partner of choice
• Disciplined portfolio management
Leadership in Innovation
• A leader in R&D investment
• Convergent technologies and consumer insight-driven approach
• Evaluating critical disease states across different segments
Strong Returns
• Investing in industry segments with significant value creation opportunities
• Strong cash flows
• 53 years of dividend increases
Scale and Technology
Breadth
• Access to industry-leading science
• Operating and cost efficiencies
• Market-leading capabilities
15. 15
A Market Leader Across All Segments
• Largest Pharma in US and one of
the fastest growing top 10 Pharma
companies globally
• Market Leader in Medical Device
Surgery, Orthopaedics and
Consumer Medical Devices
• Market Leading Consumer Health
Care Company with trusted brands
endorsed by professionals globally
Market Leadership
2014 Sales
$74.3 US Billion
Pharma
Consumer
Medical Device
$32.3B
$14.5B
$27.5B
17. 17
~70% of Free Cash Flow Returned
to Shareholders Over Last 10 Years
~30% of Free Cash Flow
Deployed Over Last 10 Years
Share Repurchases
Capital Allocation Strategic Framework
3
2
1
Value Creating Acquisitions
Free Cash Flow1
Return To Shareholders
Dividends
1. Cash flow from operations less CAPEX.
18. 18
Strengthen Our Portfolio –
Foundation for Leadership in Biologics
Accelerate Our Pipeline –
Fast-growing Oncology Platform
Access to New Markets –
Reaching new market segments with
Dabao, BioSeal™
and Elsker
Leverage Existing Scale/Capabilities –
Leadership in Orthopaedics
Advancing the Portfolio through
External Investment
19. 19
24 Brands/Platforms over $1B in sales
1994-2014 Sales and Adjusted EPS2
Investments in Innovation
(1994-2014)
~$109B
~$ 85B
~$194B
Internal
1
External
Total
~8%
Sales
CAGR
Driving Growth Through Internal &
External Innovation
1. Includes licensing.
2. Non-GAAP measure; excludes special items.
~11%
Adj. EPS2
CAGR
1994
2014
20. 20
Maximizing Long-Term Shareholder Return
Operational Efficiency
Strong Business
Dividend Increases
& Share Repurchases
Maximize
Long-Term
Shareholder
Return
Growth-Driving Investments
Broadly Based in Human Health Care
22. 22
9.8
13.2
Return to Shareholders Outperformed S&P 500
$, Indexed to 1994 values2
Cumulative Total Return to Shareholders CAGR
%, 1994-20141
0.0
2.0
4.0
6.0
8.0
10.0
12.0
1994 1999 2004 2009 2014
S&P 500 J&J
1. Data through December 2014
2. Assume investment as of December 31, 1994.
23. 23
Enterprise Summary
Strong Business
Capital Allocation
Strategy
Shareholder Return
Consistent Performance Consistent Approach Consistent Returns
1. Non-GAAP measure; excludes special items.
• 31 consecutive years
of adjusted earnings growth1
• ~ 8% Sales and 11%
Adjusted EPS1
growth
(CAGR) over 20 years
• Dividends
• Value creating acquisitions
• Share repurchases
• 53 years of dividend
increases
• Total shareholder return
outperformed S&P 500
over last 20 years
Broad Base with Deep, Innovative Pipelines
24. 24
Pharm Key Takeaways
• Strong core business and excellent commercial capabilities
• Sustainable R&D strategy, robust near-term and early-stage pipeline
• Well positioned for continued above industry growth
25. Cliff Enright, Star Cradle
Artwork from The Creative Center at University Settlement,
a non-profit organization dedicated to bringing creative arts to
people living with and beyond cancer and other chronic illnesses
Joaquin Duato
Worldwide Chairman, Pharmaceuticals
May 20, 2015
Janssen Pharmaceuticals:
Driving the Next Wave of Growth
27. Janssen Pharmaceuticals: Driving the Next Wave of Growth 27
The Global Pharmaceuticals Market…
1. IMS Market Prognosis, Sept. 2014 & Global Outlook for Medicines Through 2018 report, Nov. 2018: IMS Institute for Health Informatics.
2. May 2015 IMS Institute of Health Informatics analysis of Market Prognosis data; 2-4% CAGR forecast for 24 key countries, including EU G5, Canada, Japan and United States.
A Significant Opportunity for Growth
Total market
reached $1 Trillion
in 20141
Specialty
medicines drove
~38% of 2014
total market
growth1
~3% 2014-2019
Market CAGR for
branded products2
28. Janssen Pharmaceuticals: Driving the Next Wave of Growth 28
Janssen Has a Strong Foundation
for Continued Long-term Growth
Proven
Strategy
Robust
Innovation
Engine
Commercial
Excellence
Transformational
Medical Innovations
High Unmet
Medical Needs
FOCUSED
Therapeutic Areas5
in R&D
Productivity
1
#1 New Products
Launched Since 200914
US Commercial & Part D
Patients have Preferred
or Advantaged
Formulary Position for
Priority Janssen Brands
60+
Innovative Commercial
Access and Pricing
Agreements (2009-
2015) in 29 Countries
>80%
1. IDEA Pharma Productive Innovation Index 2015.
29. Janssen Pharmaceuticals: Driving the Next Wave of Growth 29
We Have Delivered Above-Industry Growth1
Every Quarter Since Our Last Analyst Day
WW Pharmaceuticals: Operational Sales Change vs. Prior Year Respective Quarter2
Q1’14Q3’13Q1’13Q3’12Q1’12Q3’11Q1’11Q3’10
Q1’10Q3’09Q1’09
Q3’14 Q1’15
1. Branded Industry CAGR 2.98% 2009-2014. (IMS Health, MIDAS, Q4 2014).
2. Q4 2009 and Q4 2010 operational sales change adjusted for the dynamics of the 53rd week in Q4 2009.
3. Branded Market Growth.
2013 Pharmaceutical
Analyst Day
We see potential to continue growing
above the industry average through the end of the decade3
2012 Sales: $25B
2014 Sales: $32B
30. Janssen Pharmaceuticals: Driving the Next Wave of Growth 30
DELIVER
continued growth in our core
$1B+ brands
MAXIMIZE
in-market products with $1B+
trajectory in 20151
Driving Above-Industry
Growth with the Next
Wave of Billion Dollar
Products
1. Including partner sales, where applicable; INVEGA SUSTENNA
®
known as XEPLION
®
outside
the US; SIMPONI
®
franchise includes SIMPONI ARIA
®
; INVOKANA
®
franchise includes INVOKAMET
®
known as VOKANAMET
®
outside the US.
2. Peak non-risk adjusted sales, including partner sales, where applicable. breakthrough therapy designations
INVEST
in more than 10 new products
planned to be filed by 2019,
each with $1B+ revenue potential2
Sirukumab
Rheumatoid Arthritis
Fulranumab
Osteoarthritic Pain
Daratumumab
Multiple Myeloma
Esketamine
Treatment-resistant Depression
Guselkumab
Psoriasis
JNJ-927 (ARN-509)
Pre-metastatic Prostate Cancer
AL-8176
RSV Infections
Imetelstat
Myelofibrosis
JNJ-872 (VX-787)
Influenza
JNJ-922
(Orexin-2 Antagonist)
Primary Insomnia
AL-335
HCV
JNJ-493
(FGFRi Kinase Inhibitor)
Solid Tumors
31. Janssen Pharmaceuticals: Driving the Next Wave of Growth 31
DELIVER
continued growth in our core
$1B+ brands
Driving Above-Industry
Growth with the Next
Wave of Billion Dollar
Products
32. Janssen Pharmaceuticals: Driving the Next Wave of Growth 32
Perspective on Biosimilars to REMICADE
®
in the US
DELIVER
Safety
Patent
Extrapolation
Interchangeability
Pricing
1. IMS Lifelink, custom 12-month cohort, as of Aug. 2014.
‘471 remains a valid and enforceable
patent until 3Q 2018
Unique US market dynamics will dictate
competitive response
Significant safety data with >2.2 MM
patients treated worldwide since 1998
Product differences not clinically significant
in RA, may well be in IBD
Complex biologics require clinical
evidence to ensure patient well-being
US REMICADE Patient Dynamics
1
Stable Therapy
~70%
~30%
New, Restart & Switch Patients
IBD Rheumatology
33. Janssen Pharmaceuticals: Driving the Next Wave of Growth 33
MAXIMIZE
in-market products with $1B+
trajectory in 20151
Driving Above-Industry
Growth with the Next
Wave of Billion Dollar
Products
1. Including partner sales, where applicable; INVEGA SUSTENNA
®
known as XEPLION
®
outside
the US; SIMPONI
®
franchise includes SIMPONI ARIA
®
; INVOKANA
®
franchise includes INVOKAMET
®
known as VOKANAMET
®
outside the US.
34. Janssen Pharmaceuticals: Driving the Next Wave of Growth 34
Competitive Strength
• More XARELTO®
prescriptions each week in US than
all other Novel Oral Anticoagulants (NOACs) combined2
• Well-positioned for future NOAC leadership:
– Most real world experience; most safety data generated in clinical
trials in patients studied with high risk of thrombotic events
– Most affordable and broadly reimbursed with 95% Medicare
& 93% Commercial patients on formulary covered at lowest
branded co-pay
Opportunity for Growth
• 50% of Afib patients still not treated with an anticoagulant (AC)3
• Warfarin holds 64% of total AC market1
• Five indication-seeking trials underway:
– Congestive Heart Failure
– Medically Ill
– Embolic Stroke of Unknown Source
XARELTO
®
: #1 Prescribed Novel Oral
Anticoagulant Across All Specialties & Channels
1
– Peripheral Arterial Disease
– Acute Coronary Syndrome
1. IMS Health, NPA Weekly, Total Prescriptions, Mar. 2015.
2. IMS Health, NPA Weekly, Mar. 2015.
3. Paul Hess, et.al., (2014) “Addressing barriers to optimal oral anticoagulation use
and persistence among patients with atrial fibrillation,” American Heart Journal.
MAXIMIZE
0%
5%
10%
15%
20%
Apr-13
Jun-13
Aug-13
Oct-13
Dec-13
Jan-14
Apr-14
May-14
Jul-14
Sep-14
Nov-14
Jan-15
Mar-15
Pradaxa®
XARELTO®
Eliquis®
US Novel Oral Anti-Coagulant
TRx Share in Total AC Market1
Savaysa®
TRxShare
35. Janssen Pharmaceuticals: Driving the Next Wave of Growth 35
Competitive Strength
• Approved in 65 countries; global launches underway
• US Volume and share are nearly 2x all other SGLT2s
combined
2
• Well positioned for continued SGLT2 leadership:
– #1 US Brand in Endo in NBRx; 2nd only to Januvia®
in PCP NBRx1
– 80% of US Endos and 60% of targeted PCPs actively prescribing3
– Affordable and broadly reimbursed with >90% Medicare and 80%
Commercial patients able to access INVOKANA at lowest branded co-pay
Opportunity for Growth
• Share growth of new start and switch patients
(SGLT2s are 18% of NBRx and 8.5% of TRx)4
• 6 label-enhancing T2D studies, including initial use
fixed-dose combination and add-on to basal insulin
• Pursuing 4 additional indications: Diabetic Kidney
Disease, T1DM, Weight Management, Pre-Diabetes
INVOKANA
®
: #1 in US Endocrinology
New to Brand Share
1
MAXIMIZE
0%
1%
2%
3%
4%
5%
6%
Apr-13
Jun-13
Jul-13
Sep-13
Nov-13
Jan-14
Mar-14
Apr-14
Jun-14
Aug-14
Oct-14
Nov-14
Jan-15
Mar-15
INVOKANA®
Franchise
Farxiga™
Franchise
Jardiance™ /
Glyxambi™
US Total TRx Share – All Specialties;
Type 2 Diabetes Market
(SGLT2 Class)2
0%
10%
20%
30%
40%
50%
60%
Apr-13
Jun-13
Jul-13
Sep-13
Nov-13
Jan-14
Mar-14
Apr-14
Jun-14
Aug-14
Oct-14
Nov-14
Jan-15
Mar-15
DPP4 Class
US Total TRx Share – All Specialties;
Type 2 Diabetes Market
(Less Metformin/Insulin)2
SFU Class
SGLT2 Class
GLP1 Class
1. IMS Health, NPA Weekly, NBRx, Mar. 2015.
2. IMS Health, NPA Weekly, Total Prescriptions, Mar. 2015.
3. IMS Health, Xponent, Mar. 2015.
4. IMS Health, NPA Weekly, Total and NBRx, Mar. 2015. NOTE: INVOKAMET
®
known as VOKANAMET
®
outside the US.TRxShare
36. Janssen Pharmaceuticals: Driving the Next Wave of Growth 36
STELARA
®
: #1 Biologic in Psoriasis
New to Brand Patient Share
1
MAXIMIZE
Competitive Strength
• Outpacing overall US dermatology biologic market
and fastest growing biologic PsO therapy
2
• Excellent safety profile with 5-yr safety data in label
• Most convenient dosing schedule (quarterly
administration)
• Broadly reimbursed; added to Express Scripts
formulary 2015
Opportunity for Growth
• Only 26% of eligible US patients with moderate-to-
severe psoriasis receive a biologic treatment
3
• Launched in Psoriatic Arthritis in 2013
• Future filings expected for Crohn’s Disease and
Ulcerative Colitis
1. IMS Health, Lifelink data, Mar. 2015.
2. IMS Health, DDD weekly data, Mar. 2015.
3. NHANES; Decision Resources; IMS Health; Internal Estimates, Sept. 2014.
0
10
20
30
40
2-Jan-15
16-Jan-15
30-Jan-15
13-Feb-15
27-Feb-15
13-Mar-15
27-Mar-15
Enbrel®
STELARA®
Humira®
Otezla®
CosentyxTM
2015 Weekly Gross $US (MM) – Dermatology (PsO)2
WeeklyGross$US(MM)
37. Janssen Pharmaceuticals: Driving the Next Wave of Growth 37
SIMPONI
®
and SIMPONI
®
ARIA
®
: First and Only
Subcutaneous and Intravenous Anti-TNF MAb
1. IMS Health, DDD weekly data, Mar. 2015.
2. Internal analysis of IMS data.
3. Internal analysis of IMS RxDynamics total 3-month patient share data from Mar. 2014-Mar. 2015.
4. Janssen Canada BIOADVANCE patient data.
5. IMS DDD Weekly data for Rheum & GI, Mar. 2015.
Competitive Strength
• Outpacing the global market with 30% operational growth in 2014
• Strong response to new indications fueling US results:
– SIMPONI®
100mg Ulcerative Colitis – Growing faster than the US market1
• First and only SC option FDA approved for symptom control and
improved appearance of mucosa during induction
– SIMPONI®
ARIA®
– Fastest growing US IV for Rheumatoid Arthritis1
(RA)
• Only fully human anti-TNF monoclonal antibody available in a short
30-min infusion
• Most successful RA biologic in Japan in market penetration since launch2
• Largest absolute share gain over last year for any Canadian rheumatic
disease biologic,3
UC new starts up ~70% YoY in Q14
Opportunity for Growth
• Future indications planned for SIMPONI
®
ARIA
®
in Psoriatic Arthritis
and Ankylosing Spondylitis
• New UC indication creates opportunity to grow biologic penetration
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
3.5%
Apr-09
Sep-09
Mar-10
Sep-10
Mar-11
Sep-11
Mar-12
Sep-12
Mar-13
Sep-13
Mar-14
Sep-14
Mar-15
US Immunology Market Share
(New Products – Gross $)
5
Xeljanz®
SIMPONI®
Actemra®
Entyvio®
Otezla®
MAXIMIZE
38. Janssen Pharmaceuticals: Driving the Next Wave of Growth 38
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
1,600,000
1,800,000
2,000,000
Month3
Month6
Month9
Month12
Month15
Month18
Month21
Month24
US Launch Aligned Schizophrenia
Days of Therapy1
(Rolling 3-Month Volume)
INVEGA SUSTENNA
®
: #1 Prescribed Long-Acting
Atypical Antipsychotic Therapy for Schizophrenia
1
MAXIMIZE
Competitive Strength
• Strong market leader in Long-Acting Therapies (LAT), reaching
>100K patients with schizophrenia in 20142
• Growing faster than total APS market, schizophrenia APS
segment, orals and LATs1
• 3 Month INVEGA TRINZA
TM
represents a significant new
treatment, as the only antipsychotic administered 4 times a year
– ~90% of target physicians surveyed believe INVEGA TRINZATM
will be better received by their patients than LATs currently
on the market
3
Opportunity for Growth
• Significant unmet need as only 10% of patients are being
treated with an LAT in US1
and 13% in EU G54
• Average time from diagnosis to initiation of INVEGA SUSTENNA
®
treatment in the US is >11 years5
1. IMS Health, Premier & Symphony Health data calculated into Days of Therapy, Jan. 2015.
2. IMS Health, Premier & Symphony Health data calculated into Days of Therapy, Jan. 2015; IMS Persistency study, Dec. 2013.
3. Internal market research.
4. Harmony tracker Wave 2.
5. Internal Market Research, Patient Record Review.
Abilify Maintena®
INVEGA SUSTENNA®
39. Janssen Pharmaceuticals: Driving the Next Wave of Growth 39
ZYTIGA
®
: #1 Prescribed Novel Oral
for mCRPC
1
MAXIMIZE
1. IMS Health, DDD audit, and Symphony Health data calculated into treated patients, Mar. 2015.
2. Evaluate Pharma, Dec. 2014.
3. G5 plus Russia - Country internal analysis.
4. IMS Harmony tracker Wave 4 (Nov. 2014).
Competitive Strength
• Most successful global oral oncology launch in history
2
• >50% of 2014 sales OUS; approved for metastatic
castrate resistant prostate cancer (mCRPC) in
100 countries
• Chemo-naïve share leader in US (26.5%)
1
and
EU G6 (41.7%)
3
• Strong access position, including in key Part D
population where ~70% of plan lives have preferred
use of ZYTIGA
®
before Xtandi
®
is approved
Opportunity for Growth
• Significant opportunity for penetration and expansion
of naïve market (<50% penetrated by novel products
in US, 59% in EU G5)
1,4
• Label updated with data from COU-AA-302 study
demonstrating overall survival benefit
• ZYTIGA
®
and JNJ-927 (ARN-509) have complementary
mechanisms of action; Phase 3 registration in first line
mCRPC
0
5
10
15
20
25
30
35
40
Jan-11
Jun-11
Nov-11
Apr-12
Sep-12
Feb-13
Jul-13
Dec-13
May-14
Oct-14
Mar-15
US Market Size:
Monthly Chemo-Naïve Patients1
0%
10%
20%
30%
40%
Jan-11
Jun-11
Nov-11
Apr-12
Sep-12
Feb-13
Jul-13
Dec-13
May-14
Oct-14
Mar-15
US Monthly Patient Share:
Chemo-Naïve Patients1
Xtandi®
ZYTIGA®
Total Market
ZYTIGA®
+ Xtandi®
MonthlyPatientsonTherapy(Thousands)
PatientMarketShare
40. Janssen Pharmaceuticals: Driving the Next Wave of Growth 40
IMBRUVICA
®
: #1 Prescribed Therapy
in Second Line+ CLL and MCL Indications
1
MAXIMIZE
1. IMS Health Claims Data, IMS DDD and Xponent demand, Feb. 2015.
2. Evaluate Pharma US Quarterly Net Trade Sales; Oncology drugs; Dec. 31,2014; PCYC reported earnings Q1/15.
3. 2014 DR/Decision Resources, LLC.
Competitive Strength
• Most successful US hematology / oncology launch
through 6 quarters post-launch
2
• Market share leader in new and total patient share
for CLL and MCL second line+
• Positioned to become a standard of care therapy
in B-Cell malignancies:
– Differentiated attributes of efficacy, tolerability
and durability of response
– Robust clinical development plan
Opportunity for Growth
• Pursuing 8 new indications in US with potential access
to >65,000 additional patients annually
3
• Potential naïve-treatment approvals in first line:
– Chronic Lymphocytic Leukemia
– Diffuse Large B-cell Lymphoma
– Mantle Cell Lymphoma
0%
10%
20%
30%
40%
50%
60%
Jan-13
Jun-13
Nov-13
Apr-14
Sep-14
Feb-15
CLL L2+ Total Market Share1
IMBRUVICA®
TREANDA®
OTHER
RITUXAN®
LEUKERAN®
FLUDARA®
ZYDELIG®
41. Janssen Pharmaceuticals: Driving the Next Wave of Growth 41
Summary of Selected Indication-Seeking
Trials Underway
INDICATION
PROJECTED TRIAL
COMPLETION DATE
Acute Coronary
Syndrome1 1H 2017
Type 1 diabetes
mellitus2 1H 2015
Phentermine FDC
obesity2 1H 2015
Fixed dose combination
with metformin XR
1H 2015
Initial therapy with
fixed-dose metformin
1H 2015
Crohn’s Disease1
2H 2015
1. Date reflects induction data; maintenance data will be released 1H 2016.
2. Reflects projects in Early Development.
INDICATION
PROJECTED TRIAL
COMPLETION DATE
AS (US) 2H 2016
PSA IV (US) 2H 2016
Hormone-naïve
metastatic prostate
cancer
2H 2016
CLL (elderly/unfit)
frontline single agent
2H 2015
Diffuse large B-cell
lymphoma (DLBCL)
frontline combo
1H 2017
MCL relapsed (EU) 2H 2015
CLL 2nd line
combination
2H 2015
42. Janssen Pharmaceuticals: Driving the Next Wave of Growth 42
Driving Above-Industry
Growth with the Next
Wave of Billion Dollar
Products
breakthrough therapy designations
INVEST
1. Peak non-risk adjusted sales, including partner sales, where applicable.
in more than 10 new products
planned to be filed by 2019,
each with $1B+ revenue potential1
Sirukumab
Rheumatoid Arthritis
Fulranumab
Osteoarthritic Pain
Daratumumab
Multiple Myeloma
Esketamine
Treatment-resistant Depression
Guselkumab
Psoriasis
JNJ-927 (ARN-509)
Pre-metastatic Prostate Cancer
AL-8176
RSV Infections
Imetelstat
Myelofibrosis
JNJ-872 (VX-787)
Influenza
JNJ-922
(Orexin-2 Antagonist)
Primary Insomnia
AL-335
HCV
JNJ-493
(FGFRi Kinase Inhibitor)
Solid Tumors
43. Janssen Pharmaceuticals: Driving the Next Wave of Growth 43
Industry-leading Approach to Innovation
Yielding Deep Near-Term and Early-Stage Pipelines
INVEST
Breakthrough
Therapy Designations2
NME Filings Planned by 2019,
each with $1B+ Potential1
10+
40+ Potential Line Extensions
25+
Selected
Next Generation
NME Filings2
Near-Term Pipeline Early Stage
1.Peak non-risk adjusted sales, including partner sales, where applicable.
2. Potential filings 2020–2024, non-risk adjusted.
44. Janssen Pharmaceuticals: Driving the Next Wave of Growth 44
We Will Continue to Drive Growth
DELIVER MAXIMIZE INVEST
continued growth
in core $1B+ brands
in-market products
with $1B+ trajectory
in 20151
in more than 10 new products
planned to be filed by 2019,
each with the potential to
exceed $1B in revenue
2
1. Including partner sales, where applicable.
2. Peak non-risk adjusted sales, including partner sales, where applicable.
45. Janssen Pharmaceuticals: Driving the Next Wave of Growth 45
Product Sales and Market Opportunity SummaryDELIVERMAXIMIZE
PRODUCT1 2015 1Q SALES
($MM)
Q1 YOY GROWTH
2014 MARKET
($B)2
2019 MARKET
($B)2
2014-2019
MARKET CAGR
$427 +3.7% ops $19.9 $27.4 +6.6%
$339 -4.0% ops $13.6 $21.9 +10.0%
$1,600 +2.8% ops
$45.5 $62.2 +6.5%$549 +27.4% ops
$300 +25.5% ops
$441 +38.2% ops $4.3 $7.0 +10.3%
$278 >100% $19.5 $31.6 +10.2%
$411 +18.7% ops $9.5 $6.8 -6.5%
$556 19.2% ops $6.6 $10.7 +10.1%
$116 >100% $27.4 $46.9 +11.4%
$234 -26% ops $17.2 $20.0 +3.1%
1. INVEGA SUSTENNA
®
known as XEPLION
®
outside the US; SIMPONI
®
franchise includes SIMPONI ARIA
®
; INVOKAMET
®
known as VOKANAMET
®
outside the US.
2. Evaluate Pharma, April 2015; All markets are worldwide except for XARELTO
®
(US only) and VELCADE
®
(outside the US); Immunology market includes small and large
molecules for Rheumatoid Arthritis, Ankylosing Spondylitis, Lupus, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis, and Psoriasis.
46. R&D Innovation Strategy 46
William N. Hait, M.D., Ph.D.
Global Head, Janssen R&D
R&D Innovation Strategy
47. R&D Innovation Strategy 47
Creating Value Through Innovation
• Leader in productivity, FDA approvals, breakthrough designations
• 14 new products since 2009
• Most FDA approvals 2009-2014
1
• One of the fastest growing top-ten pharmaceutical companies
• Most admired pharmaceutical company
2
1. Data Source: fda.gov.
2. Forbes Magazine.
48. R&D Innovation Strategy 48
Innovation Across Therapeutic Areas
More Than 10 NME Filings and 40 LE Filings Planned 2015-2019
ONCOLOGY IMMUNOLOGY NEUROSCIENCE INFECTIOUS DISEASES
& VACCINES
CARDIOVASCULAR
& METABOLISM
Daratumumab
• Multiple myeloma (MM)
double refractory
• Relapsed refractory MM
• Frontline MM (non-transplant)
• Frontline MM (transplant)
JNJ-927 (ARN-509)
• Pre-metastatic prostate cancer
• Chemo-naïve prostate cancer
(ZYTIGA
®
combo)
JNJ-493
(FGFRi kinase inhibitor)
• Urothelial cancer
Imetelstat
• Myelofibrosis relapse/
refractory
• MDS low/intermediate risk
Guselkumab
• Psoriasis
Sirukumab
• Rheumatoid arthritis
STELARA
®
• Pediatric psoriasis* (EU)
• Crohn's disease
• Ankylosing spondylitis
• Nr-Axial SpA
• Ulcerative colitis
SIMPONI
®
/
SIMPONI®
ARIA®
• Nr-Axial SpA, SC (EU)*
• PSA, IV (US)
• AS, IV (US)
• JIA, IV formulation (US)
• Pediatric UC, SC
• JIA, SC (EU)
Fulranumab
• Osteoarthritis pain
Esketamine
• Treatment-resistant
depression
• Major depressive disorder
at imminent risk for suicide
JNJ-922 (Orexin-2
antagonist)
• Primary insomnia
Monovalent Ebola
• Vaccine regimen
JNJ-872 (VX-787)
• Influenza A
AL-8176
• RSV infection
AL-335
• HCV
PREZISTA
®
• HIV with STR C/F/TAF
EDURANT
®
• Pediatric HIV*
• HIV STR with F/TAF
• HIV STR with dolutegravir
• HIV long acting
maintenance therapy
SIRTURO
®
• Pediatric TB
INVOKANA
®
• FDC with metformin
extended release (XR),
including initial therapy
(US)
• Initial therapy with FDC
with metformin immediate
release (US)
• Type 1 diabetes mellitus
• FDC with phentermine for
obesity
XARELTO®
(US)
• Congestive heart failure
• Embolic stroke of
undetermined source
(ESUS)
• Peripheral arterial disease
• Medically ill
• Pediatric VTE
Line ExtensionsNew Molecular Entities* In registration
IMBRUVICA
®
• CLL 2nd line combo
• CLL (elderly/unfit) frontline
singe agent
• CLL (young/fit) frontline
combo
• CLL frontline combo with
GA101
• Mantle cell lymphoma
(MCL) relapsed (EU)
• MCL frontline transplant
ineligible
• Follicular lymphoma
relapsed refractory
• DLBCL frontline combo
YONDELIS
®
• Soft tissue sarcoma*
• Relapsed ovarian cancer
(US)
ZYTIGA
®
• Hormone-naïve metastatic
prostate cancer (EU)
53. R&D Innovation Strategy 53
0 2 4 6 8
Focused, Seamless R&D
• Responsible for discovery, clinical
development through launch and
life cycle management
• Promotes efficient phase
transitions
• Focused on high-priority disease
areas that address major unmet
needs ISHD
COPD
Pneumonia
Lung Cancer
HIV/AIDS
Diarrhea
Diabetes
Road Injuries
Hypertension
Stroke
Top Ten Causes of Death Globally1
Deaths (MM)
Janssen priority
1. WHO Disability-Adjusted Life Years (DALYs) 2000-2012 World Score by Cause.
54. R&D Innovation Strategy 54
Disease Area Strongholds
• Concentrate R&D investment in high-priority assets
• Goal is to consistently deliver differentiated products to patients
• Understand basis of disease and prioritize key pathways and targets
in context
• Build or acquire best assets
• Appreciate importance of targets in context
• Leads to investment in assets with higher success rates
Biotech-like Teams within the Therapeutic Areas
55. R&D Innovation Strategy 55
Winning Through a Disease Centric Approach
• Attract top scientific and commercial talent
• Engage world’s best collaborators and partners
• Prioritize investments
• Streamline clinical development
• Gain early scientific, clinical and market insights
• Drive confident decision making
56. R&D Innovation Strategy 56
Confident Decision Making
• Prostate
– Abiraterone (ZYTIGA®
) and JNJ-927 (ARN-509) – Phase 1 and 2 data
• Heme Malignancies
– Ibrutinib (IMBRUVICA®
) – Phase 1 data
– Imetelstat – one investigator-initiated study
• Respiratory
– AL-8176 and JNJ-872 (VX-787) – data from healthy normal volunteers
• Alzheimer’s
– Anti-Tau vaccine – pre-clinical data and biomarker samples
• Rheumatoid Arthritis
– COVA-322 FynomAb®
– pre-clinical data
• Thrombosis
– JNJ-375 (“Ichorcumab”) – pre-clinical data
Based on Deep Expertise and Early Insights
57. R&D Innovation Strategy 57
Broad and Deep Research Capabilities
• Biotechnology
• Medicinal chemistry
• Vaccine platforms
• Research operations
• Diagnostics
Made Available to Collaborators
58. R&D Innovation Strategy 58
Biotechnology Center of Excellence
• Monoclonal antibodies
• Enhanced function and
bi-specific antibodies
• Alternative scaffolds
• Cell therapies
Technologically Advanced Capabilities
59. R&D Innovation Strategy 59
Biotechnology Center of Excellence
• Monoclonal antibodies
• Enhanced function and
bi-specific antibodies
• Alternative scaffolds
• Cell therapies
Technologically Advanced Capabilities
60. R&D Innovation Strategy 60
Biotechnology Center of Excellence
• Monoclonal antibodies
• Enhanced function and
bi-specific antibodies
• Alternative scaffolds
• Cell therapies
Technologically Advanced Capabilities
Guselkumab
Sirukumab
Fulranumab
Daratumumab
61. R&D Innovation Strategy 61
Biotechnology Center of Excellence
• Monoclonal antibodies
• Enhanced function and
bi-specific antibodies
• Alternative scaffolds
• Cell therapies
Technologically Advanced Capabilities
Daratumumab
CSL-362 Bi-functionals
CD19xCD3
CD123xCD3
ADCC / CDC T-CELL
REDIRECTION
Listeria (prostate, lung)
VISTA
OX-40
PD-1
VACCINE STRATEGY
DuoBody®
DART
Fynomab
62. R&D Innovation Strategy 62
Biotechnology Center of Excellence
• Monoclonal antibodies
• Enhanced function and
bi-specific antibodies
• Alternative scaffolds
• Cell therapies
Technologically Advanced Capabilities
CNTO-2476
63. R&D Innovation Strategy 63
Biotechnology Center of Excellence
• Monoclonal antibodies
• Enhanced function and
bi-specific antibodies
• Alternative scaffolds
• Cell therapies
Technologically Advanced Capabilities
Insulin
Glucagon
Somatostatin
DAPI
64. R&D Innovation Strategy 64
Discovery Sciences
• Medicinal chemistry
– Vast chemical library
– “-omics” platforms
– RNA interference
– Fragment-based chemistry
– Bioinformatics
– Gene editing
• Alios BioPharma acquisition
– Nucleoside and nucleic acid
chemistry
Powerful Support for Small Molecules
Imetelstat
65. R&D Innovation Strategy 65
Vaccines
• Adenoviral vectors induce humoral
and cellular immunity
• PER.C6®
cell line for high yield
production
– Ebola ADV.26, HIV, RSV
• Ebola provides validation
– Partnership with Bavarian Nordic
for modified vaccinia Ankara (MVA)
vector
– Promising early results
Validating Key Crucell Platforms
Prime
boost
vaccination
Production on permissive primary
Chicken Embryo Fibroblasts
Production on complementing
PER.C6®
cells
66. R&D Innovation Strategy 66
Research Operations
• Worldwide clinical trials
• Develop, file, and launch drugs
across the globe
• Execution excellence
• Leading success rates
• >$200 million in annual
efficiencies
1
• Formulation technologies
– Long-acting injectables
– Non-absorbable orals
Operational Excellence Enhances Productivity
The Fastest Drug Developers (2000-2013)2
Median Clinical
Duration
(mos.)
Median NDA
Approval
Duration (mos.)
Total Median
Duration
(mos.)
Janssen (J&J) 47 10 57
Company A 47 9 56
Company B 51 13 64
Company C 55 19 73
Company D 55 6 61
1. Internal estimates.
2. Source: CenterWatch 2014 study of 307 drugs approved between 2000-2013.
67. R&D Innovation Strategy 67
Bold Move in Precision Medicine
• Virco viral diagnostics
• Veridex CellSearch®
CTC test
• “Harpoon” next-gen cell capture
and molecular analysis
• Biocartis collaboration in point-of-care
molecular diagnostics
– molecular analysis of cells, tissues and
circulating nucleic acids
• Translate predictive biomarkers
to companion diagnostic tests and
evaluate disease susceptibility
Integrated Diagnostics
“Harpoon”
Biocartis
68. R&D Innovation Strategy 68
Internal Scientific Strengths
Augments Our External Innovation Strategy
Five Therapeutic Areas
Immunology
Infectious Diseases/Vaccines
Neuroscience
Cardiovascular/Metabolism
Oncology
Research Capabilities
Biotechnology
Discovery Sciences
Vaccines
Research Operations
Diagnostics
69. R&D Innovation Strategy 69
Internal Strength and External Collaborations
• J&J Innovation Centers establish
presence in major research hubs
• J&J Innovation-JLABS incubators
create strategic relationships
• J&J Innovation-Janssen
Business Development focused
on late-stage opportunities
• J&J Innovation-JJDC adds
strategic investments
An Elegant Mix
Internal
Scientific
Strength
External
Innovation
71. R&D Innovation Strategy 71
Focused, Prioritized R&D
• Generates extensive data for label
• Expedites regulatory review process
• Enhances launch and growth in market
• Coordinates global launches
• Optimizes access to new products
• Strong life-cycle management
• Real-world evidence for continuous
in-market value creation
Robust Investments in Our Assets
72. R&D Innovation Strategy 72
Envisioning a World without Disease
• Janssen Human Microbiome Institute
• Janssen Prevention Center
• Disease Interception Accelerator
To Sustain Long-term Growth
73. R&D Innovation Strategy 73
Accomplishments Validate Our Innovation Strategy
• New products drive current and future growth
• Disease strongholds focus our investment
• Prevention and interception envision a healthier future
• We attract top leadership and talent
• Good corporate citizenship, data transparency, global public health
• Efficient, value-based operations
Set Out to Win as Medical Innovators
75. R&D Innovation Strategy 75
R&D Productivity Second to None
Cumulative Sales of Brands Launched from 2009 to 2014
RANK COMPANY ($MM)
1 18,715
2 Gilead Sciences 13,414
3 Novartis 7,490
4 Biogen Idec Corp 6,308
5 Boehringer Ingelheim 6,477
6 Pfizer 6,264
7 Actavis US 5,977
8 Sanofi Aventis 5,795
9 Takeda 5,392
10 Novo Nordisk 5,191
All brands launched since 2009 130,057
Source: IMS Health, National Sales Perspectives, Dec 2014.
76. R&D Innovation Strategy 76
accelerated
review
designations
38high-impact
journal
publications
5breakthrough
therapy
designations
20accelerated
review
designations
14accelerated
approvals
Janssen Recognized for Innovation
Note: Includes all clinically-relevant articles (original articles, reviews, and editorials, but not supplements and correspondence) published to-date in NEJM, JAMA, Lancet,
Science, and Nature citing these drugs. (OVID searches)
77. R&D Innovation Strategy 77
Productive Innovation Index 2015
1
2 Gilead
3 Novartis
4 Merck
5 Roche
6 Biogen Idec
7 Amgen
8 Celgene
9 Bayer
10 Boehringer Ingelheim
Recognized for Sustained Innovation
Seeing J&J leading the index once
again further secures its stance as
a true innovator in the market.
Mike Rea, CEO, IDEA
#1 for
3 YEARS
78. R&D Innovation Strategy 78
Marketed Products Continue to Drive Growth
Addressing Unmet Medical Need with Janssen Innovations
WHO’s Essential Medicines List
81. R&D Innovation Strategy 81
Cycle of Success
Top
Scientific Talent
Breakthrough
Innovation
Robust
Growth
Prioritized
Investments
82. R&D Innovation Strategy 82
Janssen R&D Key Takeaways
• Executing a clearly defined innovation strategy
• Building on our strong core business
• Producing a cadence of transformational innovations
• Populating our near-term pipeline and our deep early-stage pipeline
• Delivering extraordinary results
– Leader in productivity, approvals, breakthrough designations
– One of the fastest growing top-10 pharmaceutical companies
– Most FDA approvals in last six years
– More than 10 NME filings anticipated by 2019 each with $1B+ potential
– >40 line-extension filings anticipated by 2019
One of World’s Strongest R&D Organizations
84. Immunology 8484
Immunology
Sue Dillon, Ph.D.
Global Therapeutic Area Head
High-resolution computerized tomography image illustrating
erosion of the bone surface due to autoimmune disease
(blue – no bone erosion, red/yellow – bone erosion)
85. Immunology 85
Our Vision: A World Free from Immunologic Disease
World Health Organization.
Thompson Reuters IPD.
Rheumatology 2014;53:650-657.
Ann Rheum Dis. 2011;70(3):404-413.
Gastroenterology. 2013;145(1):158-165.
Decision Resources, GlobalData, Armstrong et al 2013, Lebwohl et al 2014, KOL interviews, BCG analysis.
Annu Rev Pathol. 2012;7:385-422.
Less than 10% of patients with
rheumatoid arthritis treated
with biologics achieve complete
disease remission
Only 10-15% of eligible
patients with psoriasis
receive biologics
Up to 75% of patients with
Crohn’s disease eventually
progress to surgery
Increase disease remissions in patients
with established disease New MOAs, platforms and co-diagnostics
Pioneer new approaches to achieve
disease interception in high-risk
individuals
Block earliest activation of autoimmune
cells that initiate disease
Rheumatology Gastroenterology Dermatology
86. Immunology 86
Global Immunology* Market Is Large and Growing
2014 WW Sales
Rheumatology, Gastroenterology and Dermatology
$45.5B
2019 WW Sales
$62.2B
CAGR 2014–2019: 6%
* Immunology market includes small and large molecules for Rheumatoid Arthritis, Ankylosing Spondylitis, Lupus, Psoriatic Arthritis, Crohn’s Disease,
Ulcerative Colitis, and Psoriasis.
Source: EvaluatePharma, April 2015.
$26.6B
$9.5B
$9.4B
$33.1B
$14.2B
$14.9B
Rheumatology
Gastroenterology
Dermatology
87. Immunology 87
Today’s Overview
Expand our scope and leverage our capabilities in Immunology
science into new disease areas of high unmet need
Build and fortify our in-line and near-term pipeline of assets
Launch “next generation” products
Lead in the transformation of Immunology
Guselkumab
Sirukumab
88. Immunology 88
Near-term Pipeline: Leading and Expanding in Immunology Today
Filings/approvals assumed to be in US, EU unless otherwise noted. This information is accurate as of the date hereof to the best of the Company’s knowledge.
Johnson & Johnson assumes no obligation to update this information.
APPROVED PRODUCTS
PRODUCTS IN REGISTRATION
OR PLANNED FILINGS 2015-2019
IN REGISTRATION
STELARA®
– Crohn’s disease
– Ankylosing spondylitis (AS)
– nr-AxSpA
– Ulcerative colitis (UC)
Sirukumab
– Rheumatoid arthritis (RA)
Guselkumab
– Psoriasis
SIMPONI®
ARIA®
(intravenous)
– Psoriatic arthritis (PsA), US
– AS, US
– JIA, US
SIMPONI®
(subcutaneous)
– Co-diagnostic UC
– Juvenile idiopathic arthritis (JIA), EU
– Pediatric UC
PLANNED FILINGS
SIMPONI®
(subcutaneous)
– Non-radiographic axial spondyloarthritis (nr-AxSpA), EU
STELARA®
– Pediatric Psoriasis, EU
Line Extensions
New Molecular Entities
89. Immunology 89
STELARA
®
: Scientific and Market Leadership
Psoriasis Market LeadershipScientific Breakthrough
in Multiple Diseases
Psoriasis
– Long-term safety and efficacy
with unparalleled dosing regimen
Psoriatic Arthritis
Janssen Data on File.
Marketed
IBD
– Crohn’s disease
– UC
Rheumatologic
– AS
– Nr-AxSpA
– Lupus
Phase 3
Phase 3
Phase 2
90. Immunology 90
0
20
40
60
80
100
0 2 4 8 12 16 20 24 28 32 36 40 42 44
0
20
40
60
80
0 4 8 12 16 20 24 24 24
STELARA
®
: Consistent Results Over Time
in Psoriasis and PsA
5-year Psoriasis Data
PASI 75 Responders (%)
Data from Clinical Programs
2-year PsA Data
ACR 20 Responders (%)
J Eur Acad Dermatol Venereol. 2012 Dec 20. Kavanaugh, A., et al. EULAR 2014.
244
Week Week
100
72%
63%
64%
57%
STELARA® 90mg (n=384)
STELARA® 45mg (n=382)
STELARA® 90mg (n=176)
STELARA® 45mg (n=178)
91. Immunology 91
STELARA
®
Real World Evidence
• 4,346 patients exposed to
STELARA®
followed for up
to 4 years
• No new safety signals in patients
treated with STELARA®
• STELARA®
persistency > 90%;
persistency of subcutaneous
anti-TNFs ≤ 64%
PSOLAR International Psoriasis Registry, 8th Year, 12,000+ Patients Enrolled
Reasons for stop/switch were similar across biologics
Menter A, et al. AAD 2015. P1705. * P < 0.0014
** P < 0.0001
STELARA®
† Post-hoc Analysis
Proportion of Bio-naïve Patients Continuing Therapy†
Anti-TNF 1*
Anti-TNF 3**
Anti-TNF 2**
92. Immunology 92
STELARA
®
: Addressing Unmet Need
in Crohn’s Disease
• Efficacy in highly anti-TNF-refractory patients
(Phase 2b)*
• Phase 3 Crohn’s disease program
– Anti-TNF experienced and naïve populations
– Scientific presentation of Phase 3 data anticipated
4Q ’15 and 2Q ’16
– Anticipate filing in 2015
• Phase 3 UC trial initiated
• Secukinumab and brodalumab not effective in
Crohn’s disease
• US PI for secukinumab in psoriasis includes
Warnings and Precautions regarding
Crohn’s disease exacerbations
First Clinical Evidence that IL-12/23 Blockade in IBD is Effective
*N Engl J Med 2012; 367:1519-1528. Oct. 18, 2012.
IL-12
IL-23 IL-17
TNFa
IFNg
Pro-
inflammatory
Protective
Protective
IL-23
93. Immunology 93
Guselkumab: Anti-IL-23 Human MAb for Psoriasis*
• IL-23 blockade inhibits production of multiple
cytokines beyond IL-17A and preserves
Th1 & Treg regulatory pathways
• Guselkumab has potential to provide unique
value to patients:
– Highest levels of durable skin clearance with less
intensive dosing regimens vs. anti-IL-17 class
– Potential for similar safety profile vs. long-term
blockade of IL-12 + 23 with STELARA®
– Potential for long-term, drug-free efficacy
*J Allergy Clin Immunol. Volume 133, Number 4. April 2014.
IL-23
IL-17
IL-22
TNFa
TNFa
IFNg
Guselkumab
IL-23
Keratinocyte
Proliferation
94. Immunology 94
Guselkumab: Phase 2b Psoriasis Study Results
Primary Endpoint: Patients with PGA Scores
of Cleared (0) or Minimal (1) at Week 16
Anticipate Filing in 2016
PASI 100 through Week 40
Adalimumab: 80 mg at Week 0, followed by 40 mg at Week 1 and q2w thereafter through Week 39.
Duffin, KC, et al. AAD 2014. Late breaker.
58
7
34
61
76
86 83
0
20
40
60
80
100
1
Proportion of Patients (%)
Adalimumab Placebo 5 mg
q12w
50 mg
q12w
100 mg
q8w
200 mg
q12w
Guselkumab
15 mg
q8w
*p<0.001
**p=0.002
**
* *
*
* *
25/43 3/42 14/41 25/41 32/42 36/42 35/42 0
20
40
60
80
100
0 4 8 12 16 20 24 28 32 36 40
Adalimumab Guselkumab 100 mg q8w
Proportion of Patients (%)
54%
27%
95. Immunology 95
Sirukumab: Anti-IL-6 Human MAb for RA
• Sirukumab is more potent than tocilizumab
in IL-6 signalling assays
• Sirukumab has high affinity for IL-6
(Kd = 0.16pM)
• Low serum and synovial levels of IL-6 vs.
IL-6R in RA patients
• Sirukumab Phase 2 RA data supports potential
for better efficacy vs. marketed biologics
and orals
Potential Advantages of Targeting IL-6 vs. IL-6 Receptor
Internally discovered, now partnered with GSK.
Gardner, D, et al. EULAR 2015. Preclinical Characterization. Abstract.
91-fold difference
50-fold difference
Sirukumab
Tocilizumab
Control mAb
Unstimulated
Stimulated
Sirukumab
Tocilizumab
Control mAb
Unstimulated
Stimulated
96. Immunology 96
Sirukumab Phase 2b RA Data
Anticipate Filing in 2016
0
20
40
60
80
100
0 2 4 8 12 16 20 24
Weeks
ACR20 Responders (%)
0
20
40
60
80
100
0 2 4 8 12 16 20 24
0
20
40
60
80
100
0 2 4 8 12 16 20 24
ACR50 Responders (%) ACR70 Responders (%)
Weeks Weeks
PBO Sirukumab 100mg q2 Weeks @ Week 12
Sirukumab 100mg q2 Weeks
60%
37%
83%
60% 33%
17%
Internally discovered, now partnered with GSK.
Smolen JS, et al. Ann Rheum Dis. 2014 Apr 3.
Hsu, B, et al. EULAR 2012. Remission Criteria. Abstract.
• Sirukumab showed high clinical response and remission rates through 38 weeks
• Safety results through 38 weeks were consistent with other IL-6 inhibitors
• Extensive Phase 3 RA program
– Includes superiority study vs. adalimumab
• Scientific presentation of Phase 3 data anticipated 4Q ’15 and 2Q ’16
97. Immunology 97
Early-stage Pipeline: Next Generation Products
Filings/approvals assumed to be in US, EU unless otherwise noted. *Filings expected beyond 2019. †Pending HSR clearance.
This information is accurate as of the date hereof to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information.
APPROVED PRODUCTS
PRODUCTS IN REGISTRATION
OR PLANNED FILINGS 2015-2019
SELECTED EARLY TO MID-STAGE PIPELINE*
IN REGISTRATION LEAD INDICATIONS
Rheumatology
STELARA®
– Lupus
Guselkumab
– PsA
COVA-322, FynomAb®
– RA
CNTO-9762, bispecific antibody
– RA
CNTO-6358, MAb
– Lupus
CSL-362, MAb
– Lupus
Gastroenterology
Guselkumab
– UC
VE-202, microbial therapeutic
– IBD
STELARA®
– Crohn’s disease
– AS
– nr-AxSpA
– UC
Sirukumab
– RA
Guselkumab
– Psoriasis
SIMPONI®
(subcutaneous)
– Co-diagnostic UC
– JIA, EU
– Pediatric UC
SIMPONI®
ARIA®
(intravenous)
– PsA, US
– AS, US
– JIA, US
PLANNED FILINGS
SIMPONI®
(subcutaneous)
– nr-AxSpA, EU
STELARA®
– Pediatric Psoriasis, EU
Dermatology
Toreforant (JNJ-168) oral
– Psoriasis
Pulmonary
CNTO-7160, MAb
– Asthma
RV-1729, inhaled
– COPD
RV-6153, inhaled
– COPD
Toreforant (JNJ-168), oral
– Asthma
CNTO-6785, MAb
– COPD
NNC-0142-002, MAb
– IBD
Recent exclusive Worldwide
license agreement †
Line Extensions
New Molecular Entities
98. Immunology 98
Superior Efficacy through Bispecific Targeting
of Pathogenic Cytokines for RA, PsA and AS
• COVA-322, a bispecific FynomAb®
−Retains high affinity bivalent binding
to both IL-17A and TNF-α
−Phase 1 study ongoing
• Synergistic effects of TNF-α
and IL-17 drive inflammation
and irreversible joint destruction
COVA-322
IL-17A selective
Fynomer fused to
C-terminus of the
light chain
TNF
Binding
Region
Janssen acquired Covagen in August 2014.
99. Immunology 99
Anti-NKG2D MAb*†
: Novel MOA and Co-diagnostic Strategy
• Stress pathway markedly
up-regulated in IBD
• Polymorphisms in ligands
associated with IBD – MIC locus
• Potential for genetic response
biomarkers (SNP+)
− 2/3 Crohn’s disease patients are SNP+
First-in-class, Phase 2b-ready Asset for IBD
*Janssen obtained WW License to NNC-0142-002 from Novo Nordisk in May 2015.
†Pending HSR clearance.Adapted from: Raulet D. Nature Reviews Immunology. 2003; 3: 781.
MICA
MICB
RAE-1b
ULBP
100. Immunology 100
Microbiome: Transformative Potential in IBD
Dysbiosis in
Crohn’s Disease
Gevers, D., et al. Cell Host & Microbe Volume 15, Issue 3, Pages 249-392 (12 March 2014).
Our Approach
Live microbial
oral therapeutics
VE-202
Diagnostics
Therapeutics that target
host:microbe pathways
101. Immunology 101
Novel Oral Delivery Approach for IBD
Local, rather than systemic delivery should facilitate
greater efficacy and reduction of side effects
Key focus areas
Oral Delivery for Local Effect
1
Peptide/protein, Small Molecule
Delivery
2
Antisense & Gene Therapy
3
Pathways: Jak, IL-10, TGFβ
4
, IL-12/23
102. Immunology 102
Lead in the Transformation of Immunology:
Our Approach to Disease Interception
Identification of
at-risk individuals …
… may allow interception to
alter disease trajectory …
… and prevent a lifetime of
crippling autoimmune disease
103. Immunology 103
Disease Interception in RA
Our Approach
• Deploy cutting-edge technologies to
characterize auto-reactive T & B cell
receptors in early and established RA
• New approaches to early diagnostics
and disease monitoring
• Earlier interventions that selectively
target pathogenic cells
Early Appearance of Auto-Antibodies Provides a Window for Disease Interception
Early
Disease
Pre-Disease
(Auto-antibody
positive)
Established
Disease
Inflammation
104. Immunology 104
Expanding Our Scope and Leveraging
Our Capabilities in Immunology
Immuno-oncology
Hematologic Malignancies
Lung Cancer
Prostate Cancer
Neuro-immunology
Mood Disorders
Type 1 Diabetes
Lupus
Pulmonary
Obstructive Lung Diseases
105. Immunology 105
Sustaining Our Leadership in Immunology
Expand our scope and leverage our capabilities in Immunology
science into new disease areas of high unmet need
Build and fortify our in-line and near-term pipeline of assets
Launch “next generation” products
Lead in the transformation of Immunology
Guselkumab
Sirukumab
107. Infectious Diseases 107
Our Vision
To discover and develop novel
therapeutics to prevent, treat
and cure serious infectious
diseases worldwide, improving
outcomes and patients’ lives
108. Infectious Diseases 108
Hepatitis C (HCV)
Hepatitis B (HBV)
A Rising, Global Health Pandemic
16 Percent of All Deaths Are a Result of Infectious Diseases
Human Immunodeficiency Virus (HIV)
Tuberculosis (TB)
Respiratory Syncytial Virus (RSV)
Influenza
Pathogens of
Global Concern
Ebola, Dengue
Hepatitis Respiratory
HIV
109. Infectious Diseases 109
What Do We Need to Do
Efficacy
• Broad strain coverage
• High rates of response
(cure)
• Combination therapy likely
required (replication
inhibitors preferred)
Convenience
• Route of administration
(oral in most cases)
• Frequency of dosing
(QD preferred)
• Duration of therapy
• Single tablet regimens
Safety
• Selectivity for viral targets
but not host
• Highly targeted drugs with
few side effects
Antiviral Therapies Should Be Optimized for Efficacy,
Safety and Convenience
The pace of antiviral discovery now means that efficacy, safety and
convenience may be achieved rapidly and successful drug regimens must
meet these criteria
110. Infectious Diseases 110
Our Strategy
• Replication inhibitors are the backbone of therapy in all antiviral
settings where they are approved
– Prevent viral protein synthesis and genome replication
– Reduce pool of viral proteins that block innate immunity
• Combination therapy required in many viral settings to
prevent resistance
Focus on Replication Inhibitors While Controlling Multiple
Mechanisms of Action
CureTreatDiagnosePrevent
111. Infectious Diseases 111
Nucleoside Technology Platform (Alios Acquisition)
• Library contains multiple novel modifications
1. Phosphate
2. Sugar
3. Base
• Allows for screening against a wide range of polymerases from
divergent viruses
• Highly specialized chemistry requires unique training and expertise
• Building extensive intellectual property in chemical matter targeting
all RNA viruses important to human health
Proprietary Nucleoside Analog Library Allows Rapid Screening of
Novel Viruses
1
2
3
1
112. Infectious Diseases 112
APPROVED PRODUCTS
PRODUCTS IN REGISTRATION
OR PLANNED FILINGS 2015-2019
SELECTED EARLY- TO
MID-STAGE PIPELINE1
Rich Infectious Diseases Portfolio
1. Filings expected beyond 2019. Products marketed worldwide, but not all products in all Markets/Regions. Filings/approvals assumed to be in US and EU unless otherwise noted. This information is accurate
as of the date hereof to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information. Simeprevir is jointly developed by Janssen and Medivir AB.
STR with emtricitabine & TAF developed by Gilead.
PLANNED FILINGS
FILED HIV Vaccine
HIV prevention
HIV treatment
JNJ-860 ExPEC
E.Coli vaccine; UTI prevention
JNJ-678
RSV Fusion inhibitor
RSV Pediatric Vaccine
RSV prevention
RSV Adult Vaccine
RSV prevention
AL-794
Influenza PA inhibitor
AL-516
HCV Nucleoside
JNJ-379
Capsid inhibitor HBV
HPV Vaccine
HPV prevention
EDURANT
®
– HIV Single Tablet Regimen (STR) with F/TAF
– HIV STR with dolutegravir
– HIV long acting maintenance therapy
PREZISTA
®
– HIV STR with C/F/TAF
SIRTURO
®
– Pediatric TB
JNJ-872 (VX-787)
– Flu A polymerase inhibitor
AL-8176
– RSV Nucleoside
AL-335
– HCV Nucleoside
Monovalent EBOLA
– Vaccine regimen
EDURANT
®
– Pediatric HIV
NME
LE
(US)
(EU)
(EU)
3 Medicines Recently Added to WHO Essential Medicines List
Potential 4 NMEs and 6 LEs by 2019
114. Infectious Diseases 114
Note: Statistics from 2013
HIV: Burden Remains Unacceptably High
• 35 million people living with HIV
(0.8% of world’s adult population)
• 2.1 million new HIV infections
• 1.5 million deaths annually from
AIDS (70% in Africa)
• 1.7% of all deaths globally in
children <5 years
116. Infectious Diseases 116
2006
Launched PREZISTA
®
(PI, combined with Ritonavir) for
treatment experienced patients. PREZISTA
®
became the most
successful Protease Inhibitor
2008
Launched INTELENCE
®
(NNRTI) for treatment experienced
patients with resistance to NNRTIs
2011
Launched EDURANT
®
(NNRTI) for treatment naïve HIV
patients (with viral load less than 100,000 copies/mL)
2012
Launched COMPLERA
®
(EDURANT
®
+ TRUVADA
®
) as single
tablet regimen in partnership with Gilead
2014
Launched a new fixed dose combination of PREZISTA
®
and Gilead’s cobicistat
HIV: Our Transformational Innovation
117. Infectious Diseases 117
HIV: Building on the Established Efficacy and
Safety of PREZISTA
®
and EDURANT
®
Co-develop Convenient Single Tablet Regimens (STR)
EDURANT
®
STR
Two drug combination of EDURANT®
and ViiV’s integrase inhibitor dolutegravir
(DTG) for maintenance therapy in those with fully suppressed viral replication
PREZISTA
®
STR
First PI based STR of PREZISTA®
combined with Gilead’s cobicistat,
emtricitabine, and tenofovir alafenamide (TAF)
EDURANT
®
STR Combining EDURANT®
with Gilead’s emtricitabine and TAF
119. Infectious Diseases 119
RSV Infections: No Current Treatment Options
• Pediatric: Most frequent cause of hospitalization of infants and young
children in industrialized countries
• Adult: Under diagnosed in the elderly, with serious consequences
Source: World Health Organization; Collins et al, Journal of Virology (2008); Pfeil et al, Medicine (2014);
CDC MMWR Dec 05 2014; CDC MMWR Mar 01 2013; CDC MMWR Mar 05 2010; Falsey, et al, NEJM (2005)
Approximately two-thirds of infants
are infected in their first year of life
Estimated 132,000-172,000
hospitalizations
2.1 million outpatient visits annually
among children <5 years old in the US
Hospitalization costs alone exceed
$1 Billion
Estimated 177,000 hospitalizations and
14,000 deaths a year in the US
120. Infectious Diseases 120
RSV: Critical Pathways and Targets
• Inhibition of viral replication
(polymerase)
− AL-8176, nucleoside analog −
Completed Phase 2a
− Non-nucleoside inhibitors −
Preclinical
• Inhibition of virus fusion
− JNJ-678 / JNJ-516 − Phase 2a
Focused on Multiple Mechanisms of Action to Inhibit Viral Replication
and Re-infection
1. Palivizumab approved for prophylaxis
Antibodies1
121. Infectious Diseases 121
AL-8176 375 mg Q12 (N=8)
AL-8176 750 mg LD/150 mg MD (N=7)
AL-8176 750 mg LD/500 mg MD (N=8)
Pooled Placebo (N=12)
0 1 2 3 4 5 6 7 8 9 10
0
1
2
3
4
5
6
RSV: AL-8176 Nucleoside Analog Achieved
Significant Reduction in Viral Load
Phase 2a Human Challenge Study; All Patients Achieved Undetectable
Viral Load
Viral Load (log10 PFUe/mL)
LD: Loading Dose
MD: Maintenance Dose
Days After First Dose
Dosing Period
Source: Devincenzo, IDSA 2014C
122. Infectious Diseases 122
AL-8176 375 mg Q12 (N=8)
AL-8176 750 mg LD/150 mg MD (N=7)
AL-8176 750 mg LD/500 mg MD (N=8)
Pooled Placebo (N=12)
0 1 2 3 4 5 6 7 8 9 10
0
1
2
3
4
5
6
7
RSV: AL-8176 Achieved Significant Reduction
in Symptom Score
Phase 2a Human Challenge Study
LD: Loading Dose
MD: Maintenance Dose
Total Symptom Score
Days After First Dose
Dosing Period
Source: Devincenzo, IDSA 2014C
123. Infectious Diseases 123
RSV: Further Clinical Development
• AL-8176 nucleoside analog
− Phase 1 study in hospitalized infants ongoing
− Phase 2b study in hospitalized infants planned for early 2016
− Phase 2b study in hospitalized adults planned for early 2016
• JNJ-678 fusion inhibitor
− Human challenge study ongoing
− Phase 1 study in hospitalized infants planned for late 2015
• Only company with portfolio allowing to study combinations in RSV
infected patients to optimize treatment outcomes
Pursuing Pediatric and Adult Indications in Parallel
125. Infectious Diseases 125
Influenza: Resistance Emerging to Current
Standard of Care
• 1 billion cases and 300,000-500,000 deaths annually worldwide
• 10-20% of the population in developed countries infected each season
• The risk of developing serious complications is especially high in the very young
and the elderly
Source: World Health Organization; Kostova et al, PLOS ONE (2013); Zhou et al, Clinical Infectious Diseases (2012);
CDC MMWR Aug 27, 2010; Sleeman, K. et al, AAC (2010)
Hospitalization rates highest in
persons >65 years and <1 year
US: annual death toll 3,300-49,000
In the US from 2005 to 2011, each season had an estimated average of
• 19 million total cases
• ~8.5 million cases attended to by a medical specialist
• 128,000 hospitalizations
126. Infectious Diseases 126
Influenza: Critical Pathways and Targets
• JNJ-872, PB2 inhibitor Phase 2b
• AL-794, PA inhibitor
Starting Phase 1 Q3 ’15
Focused on Multiple Mechanisms of Action to Inhibit Viral Replication
(Polymerase)
Polymerase Complex
(PA, PB1, PB2)
127. Infectious Diseases 127
Influenza: JNJ-872 PB2 Inhibitor Achieved
Significant Reduction in Viral Load
Phase 2a Human Challenge Study
Dosing Period
0 1 2 3 4 5 6 7
Day
0
2
4
6
Mean Viral Load
(Log10 copies/mL)
Source: Vertex, data on file.
128. Infectious Diseases 128
% Subjects with
Unresolved Symptoms
Influenza: JNJ-872 Achieved Significant Reduction
in Symptom Duration
Phase 2a Human Challenge Study
Day
Dosing Period
0 1 2 3 4 5 6 7
100
75
50
25
0
Source: Vertex, data on file.
129. Infectious Diseases 129
Influenza: Further Clinical Development
• JNJ-872 PB2 inhibitor
− Phase 2b study in adult outpatients ongoing
• AL-794 PA inhibitor
− Phase 1 healthy volunteer study planned for Q3 ’15
− Phase 2a human challenge study planned for early 2016
• Will study potential combinations in 2016
− Potential for two replication inhibitors
First Opportunity to Combine Multiple Influenza Polymerase Inhibitors
in the Clinic
131. Infectious Diseases 131
HCV: Major Public Health Challenge
Still an unmet medical need for:
• Pan-genotypic regimen
• Short treatment duration
• Simplified treatment regimen
• Therapy to address both cirrhotic
and non-cirrhotic patients
170 million
infected
worldwide
135. Infectious Diseases 135
HCV: Potential for New Simplified Treatment
Options
Develop Short-Duration, Highly Effective, Pan-Genotypic,
All-Oral Regimens
1. Pending HSR clearance
Note : RVR and ETR were defined as HCV RNA < LLOQTND at Week 4 of treatment and at the end of treatment (Week 8), respectively. SVR4, SVR8 and SVR12 were defined as HCV RNA < LLOQ 4, 8 and 12 weeks after the
completion of treatment, respectively. EASL, 2015
Exclusive Worldwide License
and Collaboration with
Achillion1:
ACH-3102 NS5A inhibitor
ACH-3422 NS5B RNA polymerase
inhibitor
Sovaprevir NS3/4A protease
inhibitor
ACH-3102, FDA Fast Track
Designation
ACH-3102 + Sofosbuvir
(‘Proxy’ Study)
6-week Treatment:
Final Efficacy ResultsOptimization of NS5A Inhibitors Against Resistance
End groups of ACH-3102 were optimized to retain
activity against resistant variants
136. Infectious Diseases 136
HCV: Simeprevir
• SMV / SOF indication approved
• Final results
1, 2
of Phase 3 OPTIMIST
confirmed safety and efficacy
• HCV TARGET
3
confirmed safety
and efficacy in real-world setting
1. Kuo, EASL 2015
2. Lawitz, EASL 2015
3. Jensen, AASLD 2014
Next Generation Protease Inhibitor Approved in 47 Countries
137. Infectious Diseases 137
HCV: AL-335 (Phase 1b) and AL-516 (Preclinical)
• AL-335 (uridine base) and AL-516 (guanosine base) are potent nucleosides
• Excellent preclinical safety profile with no inhibition of human polymerase;
compounds are not substrates for human mitochondrialRNA polymerase
Distinct Resistance Profiles Provide Opportunity for Highly Efficacious,
Pan-genotypic Regimen
Compound
HCV Genotype EC50 (nM)
GT1a GT1b GT2b GT3a GT4a
AL-335 60 40 40 60 60
AL-516 2.6 3.2 2.3 2.8 4
138. Infectious Diseases 138
HCV: Future Clinical Development
• Complete multiple ascending dose study of AL-335
• Initiate large Phase 2 study combining our assets with
Achillion compounds
• Move regimen into Phase 3 by early 2017
139. Infectious Diseases 139
APPROVED PRODUCTS
PRODUCTS IN REGISTRATION
OR PLANNED FILINGS 2015-2019
SELECTED EARLY- TO
MID-STAGE PIPELINE1
Rich Infectious Diseases Portfolio
1. Filings expected beyond 2019. Products marketed worldwide, but not all products in all Markets/Regions. Filings/approvals assumed to be in US and EU unless otherwise noted. This information is accurate
as of the date hereof to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information. Simeprevir is jointly developed by Janssen and Medivir AB.
STR with emtricitabine & TAF developed by Gilead.
PLANNED FILINGS
FILED HIV Vaccine
HIV prevention
HIV treatment
JNJ-860 ExPEC
E.Coli vaccine; UTI prevention
JNJ-678
RSV Fusion inhibitor
RSV Pediatric Vaccine
RSV prevention
RSV Adult Vaccine
RSV prevention
AL-794
Influenza PA inhibitor
AL-516
HCV Nucleoside
JNJ-379
Capsid inhibitor HBV
HPV Vaccine
HPV prevention
EDURANT
®
– HIV Single Tablet Regimen (STR) with F/TAF
– HIV STR with dolutegravir
– HIV long acting maintenance therapy
PREZISTA
®
– HIV STR with C/F/TAF
SIRTURO
®
– Pediatric TB
JNJ-872 (VX-787)
– Flu A polymerase inhibitor
AL-8176
– RSV Nucleoside
AL-335
– HCV Nucleoside
Monovalent EBOLA
– Vaccine regimen
EDURANT
®
– Pediatric HIV
NME
LE
(US)
(EU)
(EU)
Potential 4 NMEs and 6 LEs by 2019
140. Infectious Diseases 140
In Conclusion, Making a Difference
• Optimize treatments for efficacy,
safety and convenience
• Continue our growth in HIV
• Drive paradigm shift in the
treatment of RSV and flu
• Develop HCV therapies to
improve outcomes
• Potential 4 NME’s and 6
LEs by 2019
Corbis-42-25116849.jpg
141. Morning Speakers
May 20, 2015
Q&A Panel 1
Dorethey Gorham, Day of the Armada Dorethey is a
joyful, self-taught artist living with arthritis, general
anxiety syndrome, and diabetes.
142. Janssen Pharmaceuticals: Driving the Next Wave of Growth 142
Guest Panelists
Jennifer Taubert
Company Group Chairman, The Americas
Jay P. Siegel, MD
Chief Biotechnology Officer and
Head, Scientific Strategy and Policy
145. Neuroscience 145
Brain Disorders and Chronic Pain Cause Enormous
Human Suffering
44.4 million people have dementia
worldwide
By 2030 depression will be the
#1 global cause of disability
Affects ~30 million people
worldwide
One in four Americans lives
in chronic pain
Schizophrenia
Severe Mood
Disorders
Alzheimer’s
Disease
Chronic
Pain
146. Neuroscience 146
Janssen Leading the Way in Next
Neuroscience Frontier
• Leveraging scientific advances in neural plasticity,
cellular resilience
• Building on strategic advantages, internal expertise
and strong external networks
• Advancing methodologies in clinical trials, biomarkers,
translational medicine
• Moving earlier into disease processes from diagnose
and treat to predict and preempt
ALZHEIMER’S DISEASE
MOOD DISORDERS
CHRONIC PAIN
SCHIZOPHRENIA
147. Neuroscience 147
Neuroscience Portfolio
APPROVED PRODUCTS PLANNED FILINGS 2015-2019
SELECTED EARLY TO
MID-STAGE PIPELINE2
PLANNED FILINGS Alzheimer’s Disease
• Lead BACE Inhibitor
‒ Alzheimer’s dementia in asymptomatic individuals
• BACE Inhibitor back up
• Anti-Tau vaccine
‒ Prodromal Alzheimer’s disease
• AAB-003
‒ Prodromal Alzheimer’s disease
• Alpha-2C AR antagonist
‒ Neurobehavioral symptoms in Alzheimer’s disease
Mood Disorders
• JNJ-922 (Orexin-2 antagonist)
‒ Adjunctive major depressive disorder
• Sirukumab
‒ Major depressive disorder
• Orexin-1 antagonist
‒ Mood disorders
• P2X7 antagonist
‒ Mood disorders
• FAAH inhibitor
‒ Anxious depression
Paliperidone palmitate
• 3-month long-acting injectable (EU)
Esketamine (intranasal)
• Treatment-resistant depression
• Major Depressive Disorder at imminent risk
for suicide
Fulranumab
• Osteoarthritis pain
JNJ-922 (Orexin-2 antagonist)
• Primary insomnia
Point-of-care diagnostic1
• Schizophrenia
Line ExtensionsNew Molecular Entities
1. 510(k) filing in US and CE Mark in EU planned.
2. Filings expected beyond 2019. This information is accurate as of the date hereof 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.
148. Neuroscience 148
Large CNS Market with Significant Unmet Need
2014 WW Sales: $44.5B 2019 WW Sales: $43.7B
Note: Excludes OTC products.
Source: EvaluatePharma, April 2015.
Neuropsychiatric Disorders have the greatest disease burden of all diseases according to the WHO, 2015
Neuropathic
Pain $4.2B
Epilepsy
$5.6B
Parkinson’s
Disease
$2.4BSchizophrenia
$9.5B
Alzheimer’s
Disease
$4.4B
Anxiety
$1.0B 2%
Sleep
$2.0B
Mood
Disorders
$9.8B
Neuropathic
Pain $2.7B
Alzheimer’s
Disease
$5.0B
Anxiety
$0.7B 3%
Sleep
$3.2B
ADHD
$5.0B
Schizophrenia
$6.8B
Epilepsy
$6.6B
Parkinson’s
Disease
$3.5B
Mood
Disorders
$10.2B
22%
13%
21%
10%
9%
5%
5%
ADHD
$5.6B
13%
23%
15%
8%16%
11%
6%
11%
7%
CAGR 2014-2019: (0%)
149. Neuroscience 149
Schizophrenia
• Affects ~30 million people
worldwide1
• Chronic, disabling disease;
often starts in late teens or early
adulthood2
• Most patients have multiple relapses
• Medication non-adherence single
largest factor in relapse3
• Relapse fuels clinical progression
Devastating Disease, High Burden for Patients and Society
1. Global Prevalence of Schizophrenia, PLOS Medicine, 2005.
2. NIMH.
3. Weiden PJ (2004), Kozma C, Grogg A, et al. Psychiatr Serv 2004;55:886-891.
Medications and diagnostics that:
• Ensure consistent dosing and address adherence
• Free patients from need for daily oral medicines
• Allow patients and treatment team to focus on holistic care
What Do We Need?
150. Neuroscience 150
Chronic/
Residual
Repeated
Psychotic
Episodes
Pre-
morbid
Prodromal
Years
Stages of Illness
Schizophrenia: Not a Classic Neurodegenerative Disease
Yet Associated with Progressive Atrophic Changes
Can Progression and Disability be Attenuated by Delaying Relapses?
Neurons of Patient
with Schizophrenia
Neurons of Healthy
Individual 20 30 40 50
JA Lieberman, et al. Pathologic stages of schizophrenia. Biol Psychiatry 2001; 50: 884-897.Nestler, et al. Nature Reviews Neuroscience 7, 137-151 (Feb 2006).
151. Neuroscience R&D 151
INVEGA TRINZA
TM
: The Latest in a Long Legacy
of Innovation in Schizophrenia
RISPERDAL
®
INVEGA
®
HALDOL
®
Discovery DiscoveryDiscovery
RISPERDAL
®
CONSTA
®
HALDOL
DECANOATE
INVEGA
SUSTENNA
®
Technology
Prodrug ester
in oil
Technology
Nanocrystal
technology
Technology
Microsphere
technology
INVEGA
TRINZA
TM
Technology
Nanocrystal
technology
152. Neuroscience 152
PP3M: n=160
Placebo: n=145
p-value<0.0001
30 60 90 120 150 180 210 240 270 300 330 360 390 420 450
0
20
40
60
80
100
Days Since Randomization
INVEGA TRINZA™
Significantly Delays
Time to Relapse in Schizophrenia
Estimated Percent of Patients without a Relapse
Berwaerts J, Liu Y, Gopal S, et al. JAMA Psychiatry, March 29, 2015.
305 Study
Participants
153. Neuroscience 153
Antidepressant treatments that:
• Act rapidly, including in patients at imminent risk for suicide
• Are effective in patients who do not respond to
existing medicines
• Intercept disease to prevent downward course
and chronicity
What Do We Need?
Severe Mood Disorders
• Major depression: #1 cause of
disability worldwide by 20301
• ~6 million patients in US with
treatment resistant depression2
• 41,000 people died from suicide
in US in 20133
• In China, 2 million suicide attempts
each year4
• Only ~30% achieve remission using
current treatments5
• Slow onset of effect: 4 to 8 weeks
Better, Rapidly-acting Treatments Critically Needed
1. World Health Organization, “Global Burden of Mental Disorders,” 2011.
2. IMS and Truven Health.
3. National Center for Injury Prevention and Control CDC, 2014.
4. China Centers for Disease Control and Prevention, reported 2012.
5. Cleveland Clinic Journal of Medicine Volume 75 • Number 1 January 2008.
155. Neuroscience 155
Esketamine
• Intranasal
– Less invasive, outpatient access,
higher patient and prescriber
acceptance compared to intravenous
– Deliver optimal dose rapidly
to reach target
Transformational Potential Therapy for Treatment Resistant Depression
Starting Phase 3 Development with FDA Breakthrough Designation
Serotonin
NMDA
156. Neuroscience 156
Esketamine (IV) Shows Robust, Rapid Efficacy in
Treatment Resistant Depression in Phase 2a Study
Rapid and Sustained Reductions in Depression
(MADRS Score)
Esketamine
0.20mg/kg
Placebo
Esketamine
0.40mg/kg
Esketamine
0.40mg/kg1
30
20
10
0
2 Hrs
Baseline
Day 2 Day 4 Day 71 Day 14 Day 17 Day 35
1. All patients were treated with 0.4mg/kg starting day 7.
2. Placebo response and remission rates=0.
Note: Poster (52nd Annual Meeting American College of Neuropsychopharmacology, December 8-12, 2013, Florida, USA; 29th World Congress of the CINP, June 22-26, 2014, Vancouver, Canada).
157. Neuroscience 157
Esketamine (IV) Shows Robust, Rapid Efficacy in
Treatment Resistant Depression in Phase 2a Study
Rapid and Sustained Reductions in Depression
(MADRS Score)
Esketamine
0.20mg/kg
Placebo
Esketamine
0.40mg/kg
Esketamine
0.40mg/kg1
30
20
10
0
2 Hrs
Baseline
Day 2 Day 4 Day 71 Day 14 Day 17 Day 35
0%
10%
20%
30%
40%
50%
60%
70%
80%
Days 5-7
Placebo Esketamine
2
50% of Refractory Patients
Achieve Remission by Days 5-7
50%
0%
1. All patients were treated with 0.4mg/kg starting day 7.
2. Placebo response and remission rates=0.
Note: Poster (52nd Annual Meeting American College of Neuropsychopharmacology, December 8-12, 2013, Florida, USA; 29th World Congress of the CINP, June 22-26, 2014, Vancouver, Canada).
158. Neuroscience 158
Neuroactive Cytokines: A Novel Approach
to Treating Refractory Mood Disorders
• Cytokine-based immunotherapies
result in a high incidence of depression1,2
• Cytokines are elevated in patients with
TRD, and correlate with severity3,4
• Increased incidence of depression in
patients with chronic inflammatory and
autoimmune diseases5,6
• Clinical studies with anti-cytokine
antibodies for inflammatory diseases
show improvement in mood regardless
of primary disease outcome7,8
Baseline
Week 12
Improvement
DepressionTotalScore
1. Musselman 2001; 2. Raison 2005; 3. Lanquillon 2000; 4. Dahl 2014; 5. de Groot 2001;
6. Godha 2010; 7. Tyring 2006; 8. Ertenli 2012.
Sirukumab
(N=32)
Placebo
(N=11)
p<0.04
Janssen data presented at Society for Biological Psychiatry SOBP 2015, May 16, Toronto.
Sirukumab (Anti-IL-6 mAb) Improves
Depressive Symptoms
159. Neuroscience 159
Insomnia Affects About 10% of Adults
and the Majority of People with Depression
• ~85% of patients with major depressive
disorder have symptoms of insomnia,
which often persists despite treatment
with currently available sleep medications
– ~13.6 million Americans have major
depression and insomnia
• Most existing treatments “force” sleep,
rather than physiologically attenuating
the “wake drive”
• The Orexin system
regulates the wake drive
CNS Spectr. 2010 Jun;15(6):394-404.
Insomnia in patients with depression: a STAR*D report.
NIMH
Therapies that provide:
• A more physiological approach to treat insomnia
• Rapid onset of action
• Preservation of deep, restful sleep
• Minimal residual daytime sleepiness or cognitive impairment
What Do We Need?
Circadian Rhythm
160. Neuroscience 160
Selectivity for Orexin-2 Receptor May Matter
a Lot… as Does the Drug’s Half-life
OREXIN-2R OREXIN-1R/2R
Sleep Induction (LPS)
Sleep Maintenance (TST)
Normal REM/NREM
Cataplexy Risk
0
2
4
6
8
10
12
14
16
18
20
Suvorexant
0
2
4
6
8
10
12
14
16
18
20
Orexin-2
(Belsomra®
)
Orexin-1/2
2.5 Hrs
12 Hrs
Mean Half-life
161. Neuroscience 161
60
64
68
72
76
80
84
88
0 10 20 30 40 50
JNJ-922 (Orexin-2 Antagonist): Promising New
Approach to Treat Insomnia
Exploratory Phase 1a Study in Patients with Major Depressive Disorder
and Insomnia (n=20)
0
20
40
60
80
100
120
0 10 20 30 40 50
p<0.001 p<0.01
280
300
320
340
360
380
400
420
440
0 10 20 30 40 50
p<0.001
Dose (mg) Dose (mg)Dose (mg)
Time to Sleep Onset Sleep Quality Sleep Duration
LatencytoPersistentSleep
(min.)
SleepEfficiency(%)
TotalSleepTime(min.)
Reference: Internal data, study 42847922ED1002, disclosed by Minerva Neurosciences, Q1 2015.
40
0
40
0
162. Neuroscience 162
Alzheimer’s Disease
• One of the most devastating
diseases of our time
• 44.4 million people with dementia
globally1
– Number expected to triple by 20502
– 5.1 million Americans
have Alzheimer’s3
– Annual global economic cost
of dementia: $604B4
Large and Growing Prevalence with Enormous Costs to Society
1. NEJM, January 28, 2010 Vol. 362 No. 4.
2. Neurology®, American Academy of Neurology, Feb. 6, 2013.
3. Alzheimer’s Association, Changing the Trajectory of Alzheimer's Disease:
How a Treatment by 2025 Saves Lives and Dollars, 2015.
4. Alzheimer’s Disease International – Global Impact of Dementia –
2013-2050, Dec. 2013.
Advances that provide:
• Improved diagnostics to identify at-risk individuals prior to
dementia onset
• Therapies that slow or prevent disease progression with good
safety profiles
• Treatments to improve function, cognition and behavioral symptoms
What Do We Need?
163. Neuroscience 163
The Importance of Disease Interception:
Alzheimer’s Disease Is Not Alzheimer’s Dementia
Abnormal
Normal
Cognitively Normal MCI Dementia
Plaques & Tangles Cognitive Impairment
Clinical Disease Stage
PRIMARY
PREVENTION
PRESYMPTOMATIC AD DISEASE
INTERCEPTION
MCI-AD/
pAD
MILD AD
Amyloid
Tau
Brain Structure
Memory
Clinical Function
MODERATE – SEVERE AD
Amyloid
Tau
Memory
Clinical
Function
Time
Mild-to-moderate
164. Neuroscience 164
Anti-Amyloid Immunotherapy Trial
in Mild-to-moderate AD
Baseline Week 78
0 20 45 78
p=0.0031
-0.2
-0.1
0
0.1
0.2
0.3
0.4
Est.MeanChangefrom
BaselineinMean11C-PiB
Weeks
-14
-12
-10
-8
-6
-4
-2
0
2
4
p=0.02702
Bapineuzumab
(n=27)
Placebo
(n=19)
Placebo
CSF P-Tau % change from baseline
AAB-003
Phase 1 study completed1. Rinne et al. The Lancet Neurology, published online, March 1, 2010. 2. Blennow et al. Arch Neurol. 2012.
Bapineuzumab
Insight: Higher Dose, Earlier in Course of Illness
165. Neuroscience 165
Atherosclerotic
Blood Vessel
with Lipid Plaque
HMG CoA Reductase
Inhibitor (Statin) Prevents
Disease Progression
b-secretase
BACE Inhibitor
Prevents Production
of Amyloid
Brain of Individual
with Alzheimer’s
Showing Amyloid Plaque
Attenuating Atherosclerotic Plaque
Formation Prevents Heart Attack, Stroke
Attenuating Brain Amyloid Plaque
Prevents Alzheimer’s Dementia?
Elevated Blood Lipids
Adapted from Citron, NATURE REVIEWS, NEUROSCIENCE, 2004
(BACE)
166. Neuroscience 166
BACE Inhibitor Phase 1 Study in Healthy Subjects
Shows Robust and Sustained Abeta Lowering Effect
52 Study Participants
Phase 1 clinical study: “Profiling the Dynamics of CSF and Plasma Abeta Reduction with JNJ-54861911, an oral BACE Inhibitor, M Timmers, B VanBroeck, J Slemmon,
et al, Presented, ADPD 2015, Nice, France.
Dose (mg)
Steady-statemeanCSFAbeta40(%ofbaseline)
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
0102030405060708090100110120130
90% population interval
Population
Abeta40 (% of baseline) ALZ1002
BACE inhibitor:
Alzheimer’s dementia in asymptomatic
individuals (FDA Fast-Track Designation)
172. Neuroscience 172
Janssen Continues to Advance
Chronic Pain Management
• ~116 million American adults
have chronic pain1
– More than total affected by
heart disease, cancer,
and diabetes combined
– 39.6 million patients
not adequately treated2
• Pain management today
is very suboptimal
– Current therapies have limited
efficacy and carry considerable
tolerability and safety issues
1. IOM Report on Pain in America, 2010.
2. Chronic Pain EPI, Johannes et al. JoP, 2010(3).
Analgesia that provides:
• Safe and effective long-term pain relief
• Restoration of function
• Good tolerability
• No risk of abuse
What Do We Need?
173. Neuroscience 173
Fulranumab
• Anti-NGFs are transformational
therapeutics for treatment-
resistant chronic pain
– Robust efficacy in pain relief and
functional improvement substantially
better than standard of care,
including opioids
– New approach could dramatically
change the way pain is treated
• Following successful discussions
with FDA, Phase 3 program in
osteoarthritis has started in 2015
Novel Anti-Nerve Growth Factor (NGF) Biologic
Modified from Pezet and MacMahon 2006.
3
2
1
Synaptic plasticity
Gene regulation
Sensitization of nociceptors
TRPV1
trkA
ERK
PI3K
Ø
Ø
Ø
174. Neuroscience 174
Fulranumab Improves Pain and Function
in Osteoarthritis
1. WOMAC = Western Ontario and McMaster Universities Arthritis Index.
2. Phase 2 data, Sanga, et al, Janssen R&D, EULAR, 2011.
3. Clin Drug Investig. 2010;30(8):489-505.
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
OSTEOARTHRITIS PAIN
Fulranumab 3mg every 4 weeks2 (p≤0.03)
Fulranumab 10mg every 8 weeks2 (p≤0.03)
Oxycodone CR 10mg-50mg BID (p=0.051) (Afilalo, M, et al, 2000.3
)
Pain Reduction – WOMAC1 Scale, Placebo Subtracted
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
OSTEOARTHRITIS FUNCTION
Fulranumab 3mg every 4 weeks2 (p≤0.03)
Fulranumab 10mg every 8 weeks2 (p≤0.03)
Function Improvement – WOMAC1 Scale, Placebo Subtracted
1. WOMAC = Western Ontario and McMaster Universities Arthritis Index.
2. Phase 2 data, Sanga, et al, Janssen R&D, EULAR, 2011.
0.0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
175. Neuroscience 175
Neuroscience Portfolio
APPROVED PRODUCTS PLANNED FILINGS 2015-2019
SELECTED EARLY TO
MID-STAGE PIPELINE2
PLANNED FILINGS Alzheimer’s Disease
• Lead BACE Inhibitor
‒ Alzheimer’s dementia in asymptomatic individuals
• BACE Inhibitor back up
• Anti-Tau vaccine
‒ Prodromal Alzheimer’s disease
• AAB-003
‒ Prodromal Alzheimer’s disease
• Alpha-2C AR antagonist
‒ Neurobehavioral symptoms in Alzheimer’s disease
Mood Disorders
• JNJ-922 (Orexin-2 antagonist)
‒ Adjunctive major depressive disorder
• Sirukumab
‒ Major depressive disorder
• Orexin-1 antagonist
‒ Mood disorders
• P2X7 antagonist
‒ Mood disorders
• FAAH inhibitor
‒ Anxious depression
Paliperidone palmitate
• 3-month long-acting injectable (EU)
Esketamine (intranasal)
• Treatment-resistant depression
• Major Depressive Disorder at imminent risk
for suicide
Fulranumab
• Osteoarthritis pain
JNJ-922 (Orexin-2 antagonist)
• Primary insomnia
Point-of-care diagnostic1
• Schizophrenia
Line ExtensionsNew Molecular Entities
1. 510(k) filing in US and CE Mark in EU planned.
2. Filings expected beyond 2019. This information is accurate as of the date hereof 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.
176. Neuroscience 176
Neuroscience
• Transforming care for treatment resistant depression
with intranasal esketamine
• Leading the movement to non-opioid era with fulranumab
• Physiological approach to treat insomnia
with JNJ-922 (Orexin-2 antagonist)
• Advancing schizophrenia care with INVEGA TRINZA™
• Broad program in Alzheimer’s with focus on
disease interception: anti-amyloid immunotherapy,
BACE inhibitor, anti-Tau vaccine
• Developing diagnostics and biomarkers
to bring forth predictive tools and
preemptive, precision medicines
Significant Unmet Needs Remain
We Are Advancing New Science and Solutions
177. Cardiovascular & Metabolism 177177
Cardiovascular & Metabolism
James List, M.D., Ph.D.
Global Therapeutic Area Head, Cardiovascular & Metabolism