Pharmaceutical Business Review - September 13, 2018 - Quarterly ...
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Pharmaceutical Business
Review
September 13, 2018
Jessica Riley, Shells
Artwork from Reflections Art in Health
Welcome and Introductions
Joaquin Duato Jennifer Taubert Mathai Mammen, M.D., Ph.D.
Vice Chairman of the Executive Committee Executive Vice President, Global Head, Janssen Research & Development
Johnson & Johnson Worldwide Chairman, Pharmaceuticals
2
Today’s Agenda
Welcome and Introductions Lesley Fishman
Global Pharmaceutical Overview Joaquin Duato
Our Strategy for Delivering Growth
• Pipeline Progress and Growth Drivers Jennifer Taubert
• Deep Dive: Immunology and Oncology Portfolios Mathai Mammen
• Other Key Portfolio/Pipeline Opportunities
Q&A All
Closing Remarks Jennifer Taubert
3
Cautionary Note on Forward-Looking Statements
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 Measures
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 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.
4
Strategic Partnerships, Collaborations
and Licensing Arrangements
During 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:
Cardiovascular & INVOKANA® / INVOKAMET® / VOKANAMET® / INVOKAMET® XR fixed-dose combination licensed from Mitsubishi Tanabe Pharma Corporation; XARELTO ®
Metabolism/Other co-developed with Bayer HealthCare AG; and PROCRIT ®/EPREX® licensed from Amgen Inc.
REMICADE® and SIMPONI® / SIMPONI ARIA® marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi
Immunology Tanabe Pharma Corporation; TREMFYA® discovered using MorphoSys AG antibody technology; and JNJ-4500 (NKG2D) licensed from Novo Nordisk
Infectious
PREZCOBIX® / REZOLSTA® fixed-dose combination, SYMTUZA™ and ODEFSEY® developed in collaboration with Gilead Sciences, Inc.; JULUCA® developed in
Diseases collaboration with ViiV Healthcare UK; and pimodivir licensed from Vertex Pharmaceuticals, Inc.
& Vaccines
Neuroscience INVEGA SUSTENNA® / XEPLION® / INVEGA TRINZA® / TREVICTA® includes technology licensed from Alkermes Pharma Ireland Limited
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; erdafitinib
discovered in collaboration with Astex Pharmaceuticals, Inc.; imetelstat licensed from Geron Corporation; niraparib licensed from TESARO, Inc.; JNJ-4528 BCMA
Oncology CAR-T Therapy licensed and developed in collaboration with Legend Biotech USA Inc., Legend Biotech Ireland Limited (“Legend”), subsidiaries of GenScript
Biotech Corporation
Pulmonary UPTRAVI® worldwide (except for Japan) license and supply agreement with Nippon Shinyaku (co-promotion in Japan) and OPSUMIT® co-promotion agreement
Hypertension with Nippon Shinyaku in Japan
5
Global Pharmaceutical
Overview
Joaquin Duato
Vice Chairman of the Executive Committee
Johnson & Johnson
Michelle Hammer, Silence
Michelle Hammer is a NYC
native with Schizophrenia.
Global Pharmaceutical Market Continues
to Be Attractive and Dynamic
$1.4T ~5%
Pharmaceutical Estimated branded
market value by 2021 market growth 2017-2021
Source: IQVIA Source: IQVIA
Health Care Other Market
Trends Dynamics
• Global aging population increasing demand • Rising cost of health care is straining budgets
for health care of public and private payers
• New disease insights offer opportunity to • Innovators are capturing a shrinking
address unmet needs proportion of spending on drugs
• New modalities such as cell and gene therapy • Uncertainty of pricing policy proposals
can be transformational
• Competition from biosimilars is accelerating
• Machine Learning and AI will affect cost,
speed and probability in R&D
7
Our Business Model Positions
Us for Sustainable Success
Deep Scientific Expertise World-Class Commercial Capabilities
6 350+ 100%
Focused
Therapeutic
Areas
R&D Programs Operational Growth from Volume
(2017–1H 2018)
Prioritized R&D Investment
$8.4B
Invested in R&D (2017)
14
New products* approved
50/50
Approximate historical split between
since 2011; industry leader internal and external sources of growth
in $1B+ brands**
*Excludes OPSUMIT® and UPTRAVI®
Note: Internal data, 2017 **EvaluatePharma CY 2017 Sales 8Our Growth Is Double That of the Pharm
Industry ― Driven by Strong Brands
7
Sales CAGR (2010-2017)
Consecutive
8.6% years of
operational
4.3% sales growth
Janssen Global Branded Market
Sources: Internal data (Janssen Growth ex-Actelion was 8.0%)
IQVIA MIDAS sales data for Innovative Branded Products 9Delivering Above-Market Growth Through 2021
Blockbuster Industry-Leading, Additional
Portfolio Late-Stage Pipeline Growth Driver
Up to
14 10 Actelion
Blockbusters, Majority with Anticipated $1B+ Launches Sixth Therapeutic Area:
Share Growth and Line &/or Filings 2017-20211 Pulmonary Hypertension
Extension Opportunities
1. Peak non-risk adjusted sales, including partner sales 10Our Strategy for
Delivering Growth
Pipeline Progress and Growth Drivers
Jennifer Taubert Mathai Mammen, M.D., Ph.D.
Worldwide Chairman, Global Head, Janssen R&D
Pharmaceuticals
Martin Freeman, Untitled
Diagnosed with AIDS in 1990,
Martin lives in San Francisco where
he continues to create new pieces.Since Our Last Pharmaceutical Business Review
Our business remains strong, with volume gains driving growth across
our market-leading brands
• 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
We remain confident we can continue to deliver above-market
growth through 2021 in the face of challenging market dynamics
12Continued Uptake and New Indications
Driving Above-Market Growth Through 20211
Fueled by share gains and expected 50+ line extensions,
10+ with $500M+ potential
Blockbuster Portfolio
Blockbusters Mega-Blockbusters
$1B+ Brands1 $4B+ Brands1
1. Non-risk adjusted projected sales, including partner sales 13Major Line Extensions
Potential Approvals and Filings 2017-20211
ONCOLOGY CARDIOVASCULAR & METABOLISM
Front-Line Multiple Myeloma (Non-Transplant) VMP Approved Coronary Artery Disease/Peripheral Artery Disease Filed
Front-Line Multiple Myeloma (Non-Transplant) Rd 2019 VTE Prevention Medically-Ill Patients 2019
Front-Line Multiple Myeloma (Transplant) 2019 Approved
Cardiovascular Outcomes
(EU)
Subcutaneous Rapid Administration 2019
Diabetic Kidney Disease 2019
CLL Front-Line Combo with Obinutuzumab Filed
CLL Front-Line Combo with Rituximab 2020 PULMONARY HYPERTENSION
Front-Line Maintenance Mantle Cell Lymphoma 2020 Chronic Thromboembolic Pulmonary Hypertension
Filed
(CTEPH)
Follicular Lymphoma Relapsed/Refractory 2020
Fontan-Palliated 2020
Front-Line CLL (IV Fixed Duration) 2021
Chemo-Naïve Prostate Cancer (ZYTIGA® Combo) 2019 Pulmonary Arterial Hypertension IV 2019
Hormone-Naïve Prostate Cancer 2019
Localized Prostate Cancer 2021 IMMUNOLOGY
Ulcerative Colitis 2018
INFECTIOUS DISEASES & VACCINES
Psoriatic Arthritis 2019
Darunavir STR for HIV Approved
NEUROSCIENCE
Rilpivirine/Dolutegravir STR for HIV Approved
Paliperidone
palmitate Maintenance Treatment of Schizophrenia
Rilpivirine 2020
6-month (Injectable)
Long-Acting HIV (Injectable) 2019
long-acting
Maintenance
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. 14
The Company assumes no obligation to update this information.A Pipeline of Differentiated NMEs and 2019-2021 Potential Filings
BCMA CAR-T
Emerging Science Driving Patient Impact Multiple Myeloma
imetelstat
Myelofibrosis
lumicitabine*
RSV Infection
Recent Launches niraparib
In-Market Prostate Cancer
Blockbuster 2018 Filings
Portfolio
esketamine pimodivir
+ Major New
Indications Non-metastatic CRPC Treatment-Resistant Depression Influenza A
erdafitinib ponesimod
Urothelial Cancer Relapsing Multiple Sclerosis
Psoriasis
Select Next Wave of Innovation
• Oncolytic Immunotherapy Platform • Curative Hepatitis B Regimens
• Locally-Directed Therapies for IBD • T-Cell Redirection
• Factor XIa Inhibition • Glutamatergic Transmission
• Immunometabolism Modulation • Immune Checkpoint Modulation
*On clinical hold. Development timeline under review. 15STELARA®: Unique Mechanism of Action
Redefining Treatment in PsO, PsA and CD IMMUNOLOGY
Now Janssen’s Largest Product
Drivers of Current Success STELARA® CD Indication Is Contributing
• Large unmet medical need in Crohn’s disease (CD) to Solid Growth
• As the only IL-12/23, STELARA® demonstrates highly- 4,011
competitive efficacy and durability of remission in CD CD
patients PsO/PsA
3,232
• Strong uptake in CD with WW sales approaching $1B+
REPORTED NTS ($M)
• Consistent performance in large PsO/PsA markets 2,474 2,402
continues to provide a significant, solid base business 2,072
Opportunities for Growth 1,508
• STELARA® CD — ongoing trials to demonstrate expanded 1,026
clinical utility, including:
̶ H2H vs. Humira — biologic-naïve patients with moderately-
to-severely active CD
• STELARA® UC — Phase 3; anticipated filings in US, 2012 2013 2014 2015 2016 2017 1H ‘18
Canada, EU and Japan by end of Q1 2019 Source: As reported, worldwide net trade sales, indication splits are internal estimates
• STELARA® lupus — Phase 3
16TREMFYA®: Novel First-in-Class Anti-IL-23
Ongoing PsO Launch Success; Investments in New Indications IMMUNOLOGY
to Drive Growth
Drivers of Current Success
• First and only anti-IL-23 approved for PsO TREMFYA® Launch Exceeding Expectations
̶ Superior efficacy with comparative data against two different
mechanisms (H2H vs. Humira and H2H vs. STELARA® $MM WW Sales USD ($MM)
inadequate responders) $150
̶ Therapeutic longevity with sustained efficacy up to three years
$126
• Launch exceeding expectations with strong demand
̶ Rapid uptake by dermatologists demonstrates highly-
$100
competitive product profile vs. anti-IL-17s
̶ New-to-brand share in US outpacing anti-IL-17s* $72
̶ Launch-aligned, new-to-brand share performance exceeding
previous IL-17 launches* $50
$47
Opportunities for Growth $16
• ECLIPSE: H2H study vs. secukinumab in PsO (PASI 90, PASI
100 comparison at Week 48) $0 Q3 2017 Q4 2017 Q1 2018 Q2 2018
• Phase 3 for PsA under way
Source: As reported, net trade sales
• Phase 2b/3 for CD under way
• IL-23 pathway opens opportunities to treat new diseases
*Source: IQVIA Patient Claims including PsO Simple Trial Program 17Immunology: Advancing Our Leadership
Position Through 2021 and Beyond
PRODUCTS APPROVED/FILED
APPROVED PRODUCTS SELECT NEW PLATFORMS & DISEASE FOCUS
AND PLANNED FILINGS 2017-2021
APPROVED
TREMFYA®
• Psoriasis
Gastroenterology
• Novel biologic targets (e.g., NKG2D)
STELARA® • Microbiome
• Adolescent psoriasis (US) • Orally-delivered, GI-localized therapies
SIMPONI ARIA® (intravenous) and in combination
• Psoriatic arthritis (US) • Anti-sense oligonucleotide therapy
• Ankylosing spondylitis (US) • Biologic combination therapy
PLANNED FILINGS
STELARA® Rheumatology
• Ulcerative colitis • RA Bone protection
• Pediatric (6-11 yr) psoriasis • Sjögren’s syndrome
• Systemic lupus erythematosus • Lupus nephritis
TREMFYA®
• Psoriatic arthritis Other
• Crohn’s disease1 • Type 1 diabetes stages 2 & 3
SIMPONI ARIA® (intravenous) • Hidradenitis suppurativa
• Juvenile idiopathic arthritis (US)
New Molecular Entities Line Extensions
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, 2018
to the best of Johnson & Johnson’s knowledge. The Company assumes no obligation to update this information. 18ERLEADA®: Redefining Prostate Cancer Treatment
Treating Patients Earlier to Improve Outcomes ONCOLOGY
Drivers of Current Success
• Approved by US FDA — first novel oral agent in
Expanding Janssen’s Leadership in Prostate Cancer
non-metastatic disease (nmCRPC), largest
Treatment Across Continuum of Care
segment of population
̶ Proven efficacy providing 40.5 months of metastatic-
free survival (vs. 16.2 months for placebo) Non-Metastatic Metastatic
̶ Robust SPARTAN data package, NEJM publication
and positive NCCN/AUA guidelines
Hormone-
sensitive
• Strong uptake in US with urologists — payer 35K pts
access currently above 80% Biochemical
Castration- Castration- Castration-
Localized disease resistant resistant resistant
recurrence
600K pts1 LINE 1 LINE 2 LINE 2+
100K pts 45K pts
75K pts 60K pts
Opportunities for Growth
• Expected EU approval in Q1 2019 for nmCRPC Castration- +
resistant
• Broad-based approach to prostate cancer, with 1st APPROVAL2
70K pts
APPROVED
intent of creating a new foundational therapy
̶ Localized prostate cancer (ATLAS); filing expected
Focus on Early Disease (CURES) Prevent/Treat Emerging Resistance
2021
̶ Hormone-sensitive prostate cancer (TITAN); 1. Decision Resources: Prostate Cancer Landscape and Forecast, 2016 (G7 estimates)
filing expected 2019 2. US, Canada, Australia, Brazil, Taiwan, Turkey
̶ ERLEADA® plus ADT + ZYTIGA® plus prednisone
(ACIS): chemo-näive mCRPC; filing expected 2019
19IMBRUVICA®: Expanding Market Leadership
Eight Potential New Filings to Drive Growth ONCOLOGY
Drivers of Current Success
Leader in CLL L2+ New Patient Share
• First BTK inhibitor with proven efficacy and safety profile
across nine US indications 50%
̶ >120,000 patients treated WW since launch 45%
̶ Approved in 92 countries 40%
̶ Best-in-class market access 35%
30%
̶ Approvals for both monotherapy and combination therapies
25%
• Leadership in CLL (L1 & L2+), Waldenström’s 20%
macroglobulinemia (WM) (L2+) and MCL (L2+) in US new
15%
patient share
10%
Opportunities for Growth 5%
• Eight potential new filings ahead; five with $500M+ potential 0%
• New registrations could access >40,000 additional patients
annually in US alone
IMBRUVICA R3M Rituxan Benda +/- R Chlor +/- R
̶ Ibrutinib + rituximab approved in WM in US
R CHOP Fluda +/- Others Others Idela
̶ US submission of IMBRUVICA® + obinutuzumab in L1 CLL filed Obin +/- chlor Venetoclax Calquence Lena +/- R
Q3 2018
̶ Exploring new innovative combinations in L1 CLL
▪ ibrutinib + venetoclax
20DARZALEX®: Reshaping Treatment
of Multiple Myeloma ONCOLOGY
Front-Line Indications and SubQ Rapid Administration to Drive Future Growth
Drivers of Current Success
WW Launch-Aligned Sales Exceeding Multiple
• First and only anti-CD38 approved for multiple myeloma; Myeloma Analogs
approved in 70+ countries
550 USD ($M)
• Five indications approved WW from late-stage to front-line,
with two BT designations 500 DARZALEX®
̶ Approval as single agent and in combination regimens 450 EMPLICITI®
KYPROLIS®
̶ Front-line indication approved Q2 2018 in US; Q3 2018 in EU 400 NINLARO®
̶ >50,000 patients treated WW since launch 350
POMALYST®
REVLIMID®
Opportunities for Growth 300 VELCADE®
• Clinical data presentations in front-line multiple myeloma 250
− ALCYONE: non-transplant population (approved) 200
− MAIA: non-transplant population
150
− CASSIOPEIA: transplant-eligible population
100
− Additional front-line studies in combination with VRd
50
• Split-dose administration submitted Q3 2018
0
• SubQ rapid administration in Phase 3; anticipated filing Q0 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10 Q11
2H 2019
• Broad clinical development plan with 14 registration studies Source: EvaluatePharma
under way, including potential new indications such as
smoldering myeloma, AL amyloidosis, etc. 21Our Approach to Immuno-Oncology
1 2 3
Directed T-Cell Antigen Presentation/ Immune-Suppressive
Therapies Priming Combinations Cell Modulation
With Checkpoint
CAR-T Oncolytic Viruses T-Cell Checkpoint Inhibitors
T-Cell Redirection Vaccine Myeloid Cells
CD40 Agonist, STING
Agonist, TLR9 Agonist
Costimulators
22CAR-T Cell Therapy
Groundbreaking 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
23Oncology Pipeline: Building and Sustaining Our
Leadership Position Through 2021 and Beyond
PRODUCTS APPROVED/FILED EARLY-STAGE FOCUS AREAS
APPROVED PRODUCTS
OR PLANNED FILINGS 2017-2021 AND PLATFORMS
APPROVED/FILED
IMBRUVICA® DARZALEX® ZYTIGA® Oncogenic Drivers
• cGVHD R/R (US)^ • R/R MM (EU)^ • Hormone-naïve
metastatic PC^ • EGFR/cMET
• Marginal zone lymphoma^ • MM R/R combo with
• Waldenström’s PomDex (US)^ ERLEADA® • PRMT5
macroglobulinemia combo^ • Front-line MM (non-transplant) • Non-metastatic
prostate cancer^
• KRAS
VMP^
• CLL front-line combo with
(OUS) obinutuzumab*
PLANNED FILINGS1 Directed T-Cell Therapies
DARZALEX® ERLEADA® • CAR-Ts
• Front-line MM (non-transplant) Rd • Chemo-naïve PC (+ ZYTIGA®) • xCD3 bi-specific
• Front-line MM (transplant) • Hormone-naïve PC
• Subcutaneous Rapid Administration • Localized PC
• Amyloidosis • ERLEADA® fixed-dose combo Comprehensive Regimens
• MDS low/intermediate risk
niraparib for Immune Therapy
• MM R/R combo with Car/Dex
• metastatic castration-resistant PC • Oncolytic virus
IMBRUVICA® • mCRPC combination
(US) (OUS)
• CLL front-line combo with rituximab • Metastatic hormone-sensitive prostate • Antigen
• CLL watch and wait cancer combination presentation/pPriming
• MCL front-line maintenance • Vaccines
erdafitinib (FGFR inhibitor)
• MCL R/R combo with venetoclax • Urothelial cancer
(US) (OUS) • Follicular lymphoma R/R • Checkpoint/Agonist
• DLBCL front-line combination JNJ-4528 (BCMA CAR-T) combinations
• Multiple myeloma
• GVHD front-line
• Front-line CLL (IV fixed duration)
imetelstat
(EU) • Myelofibrosis
• Myelodysplastic syndrome low/
intermediate risk New Molecular Entities Line Extensions
^Approved; *In Registration
1. 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 24
no obligation to update this information. Note: Filings/approvals assumed to be in US, EU unless otherwise noted.OPSUMIT® and UPTRAVI®:
Delivering Value and Growth PULMONARY
HYPERTENSION
CTEPH Offers Substantial Opportunity
Drivers of Current Success
OPSUMIT® and UPTRAVI® Sales Since Launch
• 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 1H ‘18
gap between disease onset and physician diagnosis OPSUMIT® UPTRAVI®
• Fixed-dose combination products advancing in clinic
• Triple-therapy study under way: TRITON (with OPSUMIT®,
UPTRAVI® and tadalafil)
25Esketamine: First New MOA in Major
Depressive Disorder (MDD) in 30 Years NEUROSCIENCE
Transformational Investigational Therapy for Treatment-Resistant Depression (TRD)
and for MDD Patients at Imminent Risk for Suicide
Key Highlights Clinically-meaningful and statistically-significant
improvement in depressive symptoms (MADRS Score)
• TRD is a hard-to-treat population, with high unmet need: ~30%
of drug-treated patients with MDD have TRD and do not respond
vs. Oral AD + placebo*
to existing therapies Least Squares (LS) Mean Change (± SE) from Baseline in MADRS
Total Score Over Time
• Novel mechanism of action: glutamate receptor modulation
thought to help restore neuronal connections in patients with 0
LE Mean Change in MADRS Total Score
* Placebo + Antidepressant (n=109)
MDD Antidepressant +… (n=114)
Esketamine + Antidepressant
-5
• 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 -10 -4.0
data available at launch (1-sided
P < 0.010)
̶ Data show rapid reduction of symptoms -15 69.3%
response rate
̶ Long-term efficacy established in relapse prevention study (3003) MADRS LS
Mean
-20 52.5%
• US filing Sept. 2018; EU filing anticipated Oct. 2018 remission rate
Difference at
Day 28
Future Opportunities -25
Baseline Day 2 Day 8 Day 15 Day 22 Day 28
• MDD with imminent risk for suicide in Phase 3; US and EU (24 hrs)
Time (Days)
filing anticipated 2020
• Glutamate pathway offers opportunities for other
neuropsychiatric disorders
26Evolving Our R&D Strategy to Embrace
Future Drivers of Innovation
1 2 3
Accelerating Use Building New Disease Investing in
of Data Sciences and Pathway Area New Platforms and
in R&D Strongholds Critical Talent
27Delivering Transformational Medical Innovation
to Drive Long-Term Growth
#1
• Deep scientific expertise and world-class
commercial capabilities Pharm company
based on $1B+
• Robust, differentiated pipeline generating near- and products*
long-term growth
• Potential for significant new product filings and/or
launches ($1B+ in revenue) and >50 potential new
#4
line extensions
Globally
• Industry-leading internal and external innovation in branded
market net trade
• Proven business model continues to deliver strong sales for 2017*
performance with above-market growth
Well-positioned for continued above-market
compound annual growth through 2021
*EvaluatePharma 2017 2829
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