pharmaceutical business review
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Jessica Riley, ShellsArtwork from Reflections Art in Health
Pharmaceutical Business Review
September 13, 2018
Welcome and Introductions
2
Mathai Mammen, M.D., Ph.D.Global Head, Janssen Research & Development
Joaquin DuatoVice Chairman of the Executive Committee
Johnson & Johnson
Jennifer TaubertExecutive Vice President,
Worldwide Chairman, Pharmaceuticals
Today’s Agenda
3
Welcome and Introductions Lesley Fishman
Global Pharmaceutical Overview Joaquin Duato
Our Strategy for Delivering Growth• Pipeline Progress and Growth Drivers
• Deep Dive: Immunology and Oncology Portfolios
• Other Key Portfolio/Pipeline Opportunities
Jennifer TaubertMathai Mammen
Q&A All
Closing Remarks Jennifer Taubert
Cautionary Note on Forward-Looking Statements
4
This presentation contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other
things: future operating and financial performance, product development, market position and business strategy. The viewer is cautioned not to rely on
these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or
known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson.
Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition,
including technological advances, new products and patents attained by competitors; challenges inherent in new product research and development,
including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new and existing products;
challenges to patents; the impact of patent expirations; the ability of the company to successfully execute strategic plans, including restructuring plans;
the impact of business combinations and divestitures; manufacturing difficulties or delays, internally or within the supply chain; product efficacy or
safety concerns resulting in product recalls or regulatory action; significant adverse litigation or government action, including related to product liability
claims; changes to applicable laws, regulations and government policies, including tax laws and global health care reforms; trends toward health care
cost containment; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international
economies and legal systems and sovereign risk; increased scrutiny of the health care industry by government agencies; and the potential failure to
meet obligations in compliance agreements with government bodies. A further list and descriptions of these risks, uncertainties and other factors can be
found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned
“Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Reports on
Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at
www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Any forward-looking statement made in this presentation speaks only as of the date
of this presentation. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or
developments.
Cautionary Note on Non-GAAP Financial MeasuresThis presentation refers to certain non-GAAP financial measures. These non-GAAP financial measures should not be considered replacements for, and
should be read together with, the most comparable GAAP financial measures.
A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures can be found in the accompanying
financial schedules of the Company’s most recent earnings release of July 17,2018 and the Investor Relations section of the Company’s website at
www.investor.jnj.com.
Cardiovascular &Metabolism/Other
INVOKANA® / INVOKAMET® / VOKANAMET® / INVOKAMET® XR fixed-dose combination licensed from Mitsubishi Tanabe Pharma Corporation; XARELTO®
co-developed with Bayer HealthCare AG; and PROCRIT®/EPREX® licensed from Amgen Inc.
Immunology REMICADE® and SIMPONI® / SIMPONI ARIA® marketing partners are Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. and Mitsubishi Tanabe Pharma Corporation; TREMFYA® discovered using MorphoSys AG antibody technology; and JNJ-4500 (NKG2D) licensed from Novo Nordisk
Infectious Diseases & Vaccines
PREZCOBIX® / REZOLSTA® fixed-dose combination, SYMTUZA™ and ODEFSEY® developed in collaboration with Gilead Sciences, Inc.; JULUCA® developed in collaboration with ViiV Healthcare UK; and pimodivir licensed from Vertex Pharmaceuticals, Inc.
Neuroscience INVEGA SUSTENNA® / XEPLION® / INVEGA TRINZA® / TREVICTA® includes technology licensed from Alkermes Pharma Ireland Limited
Oncology
IMBRUVICA® developed in collaboration and co-marketed in the U.S. with Pharmacyclics, LLC, an AbbVie company; ZYTIGA® licensed from BTG International Ltd.; VELCADE® developed in collaboration with Millennium: The Takeda Oncology Company; DARZALEX® licensed from Genmab A/S; erdafitinibdiscovered in collaboration with Astex Pharmaceuticals, Inc.; imetelstat licensed from Geron Corporation; niraparib licensed from TESARO, Inc.; JNJ-4528 BCMA CAR-T Therapy licensed and developed in collaboration with Legend Biotech USA Inc., Legend Biotech Ireland Limited (“Legend”), subsidiaries of GenScriptBiotech Corporation
Pulmonary Hypertension
UPTRAVI® worldwide (except for Japan) license and supply agreement with Nippon Shinyaku (co-promotion in Japan) and OPSUMIT® co-promotion agreement with Nippon Shinyaku in Japan
Strategic Partnerships, Collaborations and Licensing ArrangementsDuring the course of this presentation, we will discuss a number of products and compounds developed in collaboration with strategic partners or licensed from other companies. Following is an acknowledgement of those relationships:
5
Michelle Hammer, SilenceMichelle Hammer is a NYC native with Schizophrenia.
Global Pharmaceutical Overview
Vice Chairman of the Executive Committee
Johnson & Johnson
Joaquin Duato
Global Pharmaceutical Market Continues to Be Attractive and Dynamic
Pharmaceutical market value by 2021
$1.4T
Source: IQVIA
Estimated branded market growth 2017-2021
~5%
Source: IQVIA
• Rising cost of health care is straining budgets of public and private payers
• Innovators are capturing a shrinking proportion of spending on drugs
• Uncertainty of pricing policy proposals
• Competition from biosimilars is accelerating
• Global aging population increasing demand for health care
• New disease insights offer opportunity to address unmet needs
• New modalities such as cell and gene therapy can be transformational
• Machine Learning and AI will affect cost, speed and probability in R&D
7
Health Care Trends
Other Market Dynamics
Our Business Model Positions Us for Sustainable Success
Focused Therapeutic Areas6
14Approximate historical split between internal and external sources of growth
50/50Invested in R&D (2017)
$8.4B
Deep Scientific Expertise
Prioritized R&D Investment
World-Class Commercial Capabilities
R&D Programs
350+
Note: Internal data, 2017
New products* approved since 2011; industry leader in $1B+ brands**
*Excludes OPSUMIT® and UPTRAVI®
**EvaluatePharma CY 2017 Sales 8
(2017–1H 2018)
100%Operational Growth from Volume
Our Growth Is Double That of the Pharm Industry ― Driven by Strong Brands
7Consecutive years of operational sales growth
Global Branded MarketJanssen
Sale
s C
AG
R (
20
10
-20
17
)
8.6%
4.3%
9Sources: Internal data (Janssen Growth ex-Actelion was 8.0%)
IQVIA MIDAS sales data for Innovative Branded Products
Delivering Above-Market Growth Through 2021
101. Peak non-risk adjusted sales, including partner sales
14Blockbusters, Majority with
Share Growth and Line Extension Opportunities
Up to
10Anticipated $1B+ Launches
&/or Filings 2017-20211
Sixth Therapeutic Area:Pulmonary Hypertension
Blockbuster Portfolio
Industry-Leading, Late-Stage Pipeline
Additional Growth Driver
Actelion
Martin Freeman, UntitledDiagnosed with AIDS in 1990, Martin lives in San Francisco where he continues to create new pieces.
Our Strategy for Delivering Growth
Pipeline Progress and Growth Drivers
Jennifer Taubert
Worldwide Chairman, Pharmaceuticals
Mathai Mammen, M.D., Ph.D.
Global Head, Janssen R&D
Since Our Last Pharmaceutical Business ReviewOur business remains strong, with volume gains driving growth across our market-leading brands
We remain confident we can continue to deliver above-market growth through 2021 in the face of challenging market dynamics
• Successfully launched TREMFYA® and ERLEADA®
• Twelve recent approvals including new indications for DARZALEX®, IMBRUVICA®, ZYTIGA®, SIMPONI ARIA®, JULUCA® and SYMTUZA™
• Filed esketamine in US (September); anticipate filing in EU in Q4
• On track to file erdafitinib (US) in Q3
• Successfully integrated Actelion with its Pulmonary Hypertension portfolio
• Strong operational sales growth and share gains
12
Continued Uptake and New Indications Driving Above-Market Growth Through 20211
Fueled by share gains and expected 50+ line extensions, 10+ with $500M+ potential
131. Non-risk adjusted projected sales, including partner sales
Blockbuster Portfolio
Blockbusters$1B+ Brands1
Mega-Blockbusters$4B+ Brands1
ONCOLOGY
Front-Line Multiple Myeloma (Non-Transplant) VMP Approved
Front-Line Multiple Myeloma (Non-Transplant) Rd 2019
Front-Line Multiple Myeloma (Transplant) 2019
Subcutaneous Rapid Administration 2019
CLL Front-Line Combo with Obinutuzumab Filed
CLL Front-Line Combo with Rituximab 2020
Front-Line Maintenance Mantle Cell Lymphoma 2020
Follicular Lymphoma Relapsed/Refractory 2020
Front-Line CLL (IV Fixed Duration) 2021
Chemo-Naïve Prostate Cancer (ZYTIGA® Combo) 2019
Hormone-Naïve Prostate Cancer 2019
Localized Prostate Cancer 2021
INFECTIOUS DISEASES & VACCINES
Darunavir STR for HIV Approved
Rilpivirine/Dolutegravir STR for HIV Approved
Rilpivirine Long-Acting Maintenance
HIV (Injectable) 2019
Major Line Extensions Potential Approvals and Filings 2017-20211
1. Filings/approvals are in the US or EU, unless otherwise noted. All dates represent first filing dates.This information is accurate as of September 13, 2018 to the best of Johnson & Johnson’s knowledge. The Company assumes no obligation to update this information.
CARDIOVASCULAR & METABOLISM
Coronary Artery Disease/Peripheral Artery Disease Filed
VTE Prevention Medically-Ill Patients 2019
Cardiovascular OutcomesApproved
(EU)
Diabetic Kidney Disease 2019
PULMONARY HYPERTENSION
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Filed
Fontan-Palliated 2020
Pulmonary Arterial Hypertension IV 2019
IMMUNOLOGY
Ulcerative Colitis 2018
Psoriatic Arthritis 2019
NEUROSCIENCE
Paliperidone palmitate 6-month long-acting
Maintenance Treatment of Schizophrenia(Injectable)
2020
14
Select Next Wave of Innovation
+ Major New Indications
Recent Launches
Non-metastatic CRPC
Psoriasis
2019-2021 Potential Filings
BCMA CAR-TMultiple Myeloma
imetelstatMyelofibrosis
lumicitabine*RSV Infection
niraparibProstate Cancer
pimodivirInfluenza A
ponesimodRelapsing Multiple Sclerosis
• Curative Hepatitis B Regimens
• T-Cell Redirection
• Glutamatergic Transmission
• Immune Checkpoint Modulation
• Oncolytic Immunotherapy Platform
• Locally-Directed Therapies for IBD
• Factor XIa Inhibition
• Immunometabolism Modulation
2018 Filings
esketamineTreatment-Resistant Depression
erdafitinibUrothelial Cancer
A Pipeline of Differentiated NMEs and Emerging Science Driving Patient Impact
In-Market Blockbuster
Portfolio
15*On clinical hold. Development timeline under review.
STELARA®: Unique Mechanism of Action Redefining Treatment in PsO, PsA and CDNow Janssen’s Largest Product
RE
PO
RT
ED
NT
S (
$M
)
20162015201420132012 2017
Source: As reported, worldwide net trade sales, indication splits are internal estimates
1,026
1,508
2,072
2,474
3,232
4,011
2,402
1H ‘18
CD
PsO/PsA
16
STELARA® CD Indication Is Contributing to Solid Growth
Drivers of Current Success
• Large unmet medical need in Crohn’s disease (CD)
• As the only IL-12/23, STELARA® demonstrates highly-competitive efficacy and durability of remission in CD patients
• Strong uptake in CD with WW sales approaching $1B+
• Consistent performance in large PsO/PsA markets continues to provide a significant, solid base business
Opportunities for Growth
• STELARA® CD — ongoing trials to demonstrate expanded clinical utility, including:
H2H vs. Humira — biologic-naïve patients with moderately-to-severely active CD
• STELARA® UC — Phase 3; anticipated filings in US, Canada, EU and Japan by end of Q1 2019
• STELARA® lupus — Phase 3
IMMUNOLOGY
TREMFYA®: Novel First-in-Class Anti-IL-23 Ongoing PsO Launch Success; Investments in New Indicationsto Drive Growth
17
TREMFYA® Launch Exceeding Expectations
WW Sales USD ($MM)
Source: As reported, net trade sales
$16
$47
$72
$126
$50
$0
$100
$150
Q4 2017 Q2 2018Q1 2018
$MM
Q3 2017
Drivers of Current Success
• First and only anti-IL-23 approved for PsO
Superior efficacy with comparative data against two different mechanisms (H2H vs. Humira and H2H vs. STELARA®
inadequate responders)
Therapeutic longevity with sustained efficacy up to three years
• Launch exceeding expectations with strong demand
Rapid uptake by dermatologists demonstrates highly-competitive product profile vs. anti-IL-17s
New-to-brand share in US outpacing anti-IL-17s*
Launch-aligned, new-to-brand share performance exceeding previous IL-17 launches*
Opportunities for Growth
• ECLIPSE: H2H study vs. secukinumab in PsO (PASI 90, PASI 100 comparison at Week 48)
• Phase 3 for PsA under way
• Phase 2b/3 for CD under way
• IL-23 pathway opens opportunities to treat new diseases
IMMUNOLOGY
*Source: IQVIA Patient Claims including PsO Simple Trial Program
APPROVED PRODUCTSPRODUCTS APPROVED/FILED
AND PLANNED FILINGS 2017-2021 SELECT NEW PLATFORMS & DISEASE FOCUS
APPROVED
PLANNED FILINGS
STELARA®
• Ulcerative colitis
• Pediatric (6-11 yr) psoriasis
• Systemic lupus erythematosus
TREMFYA®
• Psoriatic arthritis
• Crohn’s disease1
SIMPONI ARIA® (intravenous)
• Juvenile idiopathic arthritis (US)
TREMFYA®
• Psoriasis
STELARA®
• Adolescent psoriasis (US)
SIMPONI ARIA® (intravenous)
• Psoriatic arthritis (US)
• Ankylosing spondylitis (US)
1. Anticipated filing in 2022
Note: Filings/approvals are in the US or EU, unless otherwise noted. This information is accurate as of September 13, 2018to the best of Johnson & Johnson’s knowledge. The Company assumes no obligation to update this information.
Line ExtensionsNew Molecular Entities
Gastroenterology• Novel biologic targets (e.g., NKG2D) • Microbiome• Orally-delivered, GI-localized therapies
and in combination• Anti-sense oligonucleotide therapy• Biologic combination therapy
Rheumatology• RA Bone protection• Sjögren’s syndrome• Lupus nephritis
Other• Type 1 diabetes stages 2 & 3• Hidradenitis suppurativa
Immunology: Advancing Our Leadership Position Through 2021 and Beyond
18
ERLEADA®: Redefining Prostate Cancer TreatmentTreating Patients Earlier to Improve Outcomes
19
2. US, Canada, Australia, Brazil, Taiwan, Turkey
1. Decision Resources: Prostate Cancer Landscape and Forecast, 2016 (G7 estimates)
Castration-resistantLINE 1
75K pts
Metastatic
Hormone-sensitive 35K pts
APPROVED1st APPROVAL2
Prevent/Treat Emerging Resistance
Non-Metastatic
Localized disease 600K pts1
+
Biochemical recurrence 100K pts
Castration-resistant 70K pts
Castration-resistantLINE 2
60K pts
Castration-resistantLINE 2+ 45K pts
Focus on Early Disease (CURES)
Expanding Janssen’s Leadership in Prostate CancerTreatment Across Continuum of Care
Drivers of Current Success
• Approved by US FDA — first novel oral agent in non-metastatic disease (nmCRPC), largest segment of population
Proven efficacy providing 40.5 months of metastatic-free survival (vs. 16.2 months for placebo)
Robust SPARTAN data package, NEJM publication and positive NCCN/AUA guidelines
• Strong uptake in US with urologists — payer access currently above 80%
Opportunities for Growth
• Expected EU approval in Q1 2019 for nmCRPC
• Broad-based approach to prostate cancer, with intent of creating a new foundational therapy
Localized prostate cancer (ATLAS); filing expected 2021
Hormone-sensitive prostate cancer (TITAN); filing expected 2019
ERLEADA® plus ADT + ZYTIGA® plus prednisone (ACIS): chemo-näive mCRPC; filing expected 2019
ONCOLOGY
IMBRUVICA®: Expanding Market LeadershipEight Potential New Filings to Drive Growth
20
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
IMBRUVICA R3M Rituxan Benda +/- R Chlor +/- R
R CHOP Fluda +/- Others Others Idela
Obin +/- chlor Venetoclax Calquence Lena +/- R
Drivers of Current Success
• First BTK inhibitor with proven efficacy and safety profile across nine US indications
>120,000 patients treated WW since launch
Approved in 92 countries
Best-in-class market access
Approvals for both monotherapy and combination therapies
• Leadership in CLL (L1 & L2+), Waldenström’smacroglobulinemia (WM) (L2+) and MCL (L2+) in US new patient share
Opportunities for Growth
• Eight potential new filings ahead; five with $500M+ potential
• New registrations could access >40,000 additional patients annually in US alone
Ibrutinib + rituximab approved in WM in US
US submission of IMBRUVICA® + obinutuzumab in L1 CLL filed
Q3 2018
Exploring new innovative combinations in L1 CLL
▪ ibrutinib + venetoclax
Leader in CLL L2+ New Patient Share
ONCOLOGY
WW Launch-Aligned Sales Exceeding Multiple Myeloma Analogs
DARZALEX®: Reshaping Treatment of Multiple MyelomaFront-Line Indications and SubQ Rapid Administration to Drive Future Growth
0
50
100
150
200
250
300
350
400
450
500
550
21
DARZALEX®
POMALYST®
EMPLICITI®
KYPROLIS®
REVLIMID®
NINLARO®
VELCADE®
Q3 Q7Q0 Q1 Q5Q2 Q4 Q6 Q8 Q9 Q10 Q11
Drivers of Current Success
• First and only anti-CD38 approved for multiple myeloma; approved in 70+ countries
• Five indications approved WW from late-stage to front-line, with two BT designations
Approval as single agent and in combination regimens
Front-line indication approved Q2 2018 in US; Q3 2018 in EU
>50,000 patients treated WW since launch
Opportunities for Growth
• Clinical data presentations in front-line multiple myeloma
− ALCYONE: non-transplant population (approved)
− MAIA: non-transplant population
− CASSIOPEIA: transplant-eligible population
− Additional front-line studies in combination with VRd
• Split-dose administration submitted Q3 2018
• SubQ rapid administration in Phase 3; anticipated filing 2H 2019
• Broad clinical development plan with 14 registration studies under way, including potential new indications such as smoldering myeloma, AL amyloidosis, etc.
USD ($M)
ONCOLOGY
Source: EvaluatePharma
Our Approach to Immuno-Oncology
Directed T-Cell Therapies
CAR-T
T-Cell Redirection
Antigen Presentation/Priming Combinations
With Checkpoint
Oncolytic Viruses
Vaccine
CD40 Agonist, STING Agonist, TLR9 Agonist
Costimulators
T-Cell Checkpoint Inhibitors
Myeloid Cells
Immune-Suppressive Cell Modulation
1 2 3
22
CAR-T Cell TherapyGroundbreaking Immunotherapy Platform for the Treatment of Cancer
• Foundational to our strategy in immuno-oncology
• Creates a specific, potent and durable anti-tumor T-Cell response in patients
• Potential for exceptional potency and curative responses across tumor types
• Single dose can drive potent and long-lasting activity; “living drug”
• Lead program, LCAR B38M (BCMA), IND open and study now enrolling in US
• Multiple additional programs under development in hematologic malignancy and solid tumors
• Ongoing build of commercial manufacturing capabilities
23
APPROVED PRODUCTSPRODUCTS APPROVED/FILED
OR PLANNED FILINGS 2017-2021 EARLY-STAGE FOCUS AREAS
AND PLATFORMS
IMBRUVICA®
• cGVHD R/R (US)^
• Marginal zone lymphoma^
• Waldenström’smacroglobulinemia combo^
• CLL front-line combo with obinutuzumab*
DARZALEX®
• Front-line MM (non-transplant) Rd
• Front-line MM (transplant)
• Subcutaneous Rapid Administration
• Amyloidosis
• MDS low/intermediate risk
• MM R/R combo with Car/Dex
IMBRUVICA®
• CLL front-line combo with rituximab
• CLL watch and wait
• MCL front-line maintenance
• MCL R/R combo with venetoclax
• Follicular lymphoma R/R
• DLBCL front-line combination
• GVHD front-line
• Front-line CLL (IV fixed duration)
imetelstat• Myelofibrosis
• Myelodysplastic syndrome low/intermediate risk
ERLEADA®
• Chemo-naïve PC (+ ZYTIGA®)
• Hormone-naïve PC
• Localized PC
• ERLEADA® fixed-dose combo
niraparib• metastatic castration-resistant PC
• mCRPC combination
• Metastatic hormone-sensitive prostate cancer combination
erdafitinib (FGFR inhibitor)• Urothelial cancer
JNJ-4528 (BCMA CAR-T)• Multiple myeloma
DARZALEX®
• R/R MM (EU)^
• MM R/R combo with PomDex (US)^
• Front-line MM (non-transplant) VMP^
ZYTIGA®
• Hormone-naïve metastatic PC^
ERLEADA®
• Non-metastatic prostate cancer^
Oncology Pipeline: Building and Sustaining Our Leadership Position Through 2021 and Beyond
(OUS)
(EU)
(US)
(OUS)
(OUS)
P L A N N E D F I L I N G S 1
A P P R O V E D / F I L E D
Line ExtensionsNew Molecular Entities
24
(US)
Oncogenic Drivers
• EGFR/cMET
• PRMT5
• KRAS
Directed T-Cell Therapies
• CAR-Ts
• xCD3 bi-specific
Comprehensive Regimens for Immune Therapy
• Oncolytic virus
• Antigen presentation/pPriming
• Vaccines
• Checkpoint/Agonist combinations
^Approved; *In Registration1. Does not include registrations where Janssen is not the study sponsor. This information is accurate as of September 13, 2018 to the best of the Company’s knowledge. Johnson & Johnson assumes no obligation to update this information. Note: Filings/approvals assumed to be in US, EU unless otherwise noted.
Drivers of Current Success
• Global leader in pulmonary arterial hypertension (PAH) with treatments across continuum of disease
• OPSUMIT® achieved blockbuster status in 2017, less than four years after launch
• OPSUMIT® and UPTRAVI® benefitting from regulatory approvals and market access capabilities globally
Opportunities for Growth
• OPSUMIT® potential new indications:
CTEPH ― a near-term significant opportunity; filed with FDA in
April 2018 and EMA in August 2018
Fontan-palliated; Phase 3
• UPTRAVI® growth from earlier use and combination therapy
• Developing improved diagnostics to reduce current 2.5 year gap between disease onset and physician diagnosis
• Fixed-dose combination products advancing in clinic
• Triple-therapy study under way: TRITON (with OPSUMIT®, UPTRAVI® and tadalafil)
25
1H ‘18
OPSUMIT® UPTRAVI®
OPSUMIT® and UPTRAVI®: Delivering Value and GrowthCTEPH Offers Substantial Opportunity
PULMONARYHYPERTENSION
OPSUMIT® and UPTRAVI® Sales Since Launch
Esketamine: First New MOA in Major Depressive Disorder (MDD) in 30 YearsTransformational Investigational Therapy for Treatment-Resistant Depression (TRD) and for MDD Patients at Imminent Risk for Suicide
Key Highlights
• TRD is a hard-to-treat population, with high unmet need: ~30% of drug-treated patients with MDD have TRD and do not respond to existing therapies
• Novel mechanism of action: glutamate receptor modulation thought to help restore neuronal connections in patients with MDD
• Comprehensive global clinical program demonstrates superiority vs. standard of care (oral AD) in MDD
Five Phase 3 studies in TRD, with acute and long-term maintenance
data available at launch
Data show rapid reduction of symptoms
Long-term efficacy established in relapse prevention study (3003)
• US filing Sept. 2018; EU filing anticipated Oct. 2018
Future Opportunities
• MDD with imminent risk for suicide in Phase 3; US and EU filing anticipated 2020
• Glutamate pathway offers opportunities for other neuropsychiatric disorders
-25
-20
-15
-10
-5
0
Antidepressant +…
Day 28Day 22Day 15Day 8Day 2(24 hrs)
Baseline
LE M
ean
Ch
an
ge in
MA
DR
S T
ota
l S
core
Placebo + Antidepressant (n=109)Esketamine + Antidepressant (n=114)
Time (Days)
-4.0(1-sided
P < 0.010)
MADRS LS Mean Difference at Day 28
Least Squares (LS) Mean Change (± SE) from Baseline in MADRS Total Score Over Time
26
NEUROSCIENCE
Clinically-meaningful and statistically-significant improvement in depressive symptoms (MADRS Score) vs. Oral AD + placebo*
69.3% response rate
52.5% remission rate
*
Evolving Our R&D Strategy to Embrace Future Drivers of Innovation
Accelerating Use of Data Sciences
in R&D
Building New Disease and Pathway Area
Strongholds
Investing in New Platforms and
Critical Talent
1 2 3
27
Delivering Transformational Medical Innovation to Drive Long-Term Growth
• Deep scientific expertise and world-class commercial capabilities
• Robust, differentiated pipeline generating near- and long-term growth
• Potential for significant new product filings and/or launches ($1B+ in revenue) and >50 potential new line extensions
• Industry-leading internal and external innovation
• Proven business model continues to deliver strong performance with above-market growth
28
Pharm company based on $1B+ products*#1Globally in branded market net trade sales for 2017*#4
Well-positioned for continued above-market compound annual growth through 2021
*EvaluatePharma 2017
29
30
See you at our
next full-day
Pharmaceutical
Business Review
in May 2019!
Details to be provided
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