Transcript moodle.univ
Khadra LASWAD, Youssou NDAO, Anne-Félice PELLET, Laure TIQUET, Florent ZOONEKYND
1
Profile
This is an independent study performed by students from the Faculté des Sciences Pharmaceutiques de Lille The opinions expressed are our own and not necessarily those of Eisai
2
Profile
A japanese pharmaceutical company Created on December 6, 1941 15,000 employees work in America, Europe and Asia
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Profile
Manufacturing and marketing of pharmaceutical drugs, over-the counter drugs, generic medicines and veterinary medicinal products.
Sales in 2011 : 6.42 billions € R&D : 19,3% of net sales Total equity : 4,19 billions € (as of March 31, 2012)
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History
1941
Nihon Eisai Co., Ltd. established in Honjo machi, Saitama Prefecture http://eisai.com/company/profile/timeline.html
1961
Eisai listed on the first section of the Tokyo and Osaka Stock Exchanges.
Office established in Taiwan.
1981
Eisai established in California, United States.
5
History
1988
Eisai established in London, United Kingdom and in New Jersey, USA.
1989
Eisai established in Germany and Thailand http://eisai.com/company/profile/timeline.html
1991
Eisai established in China
1996
Eisai established in France 6
History
1997
ARICEPT launched in the United States, the United Kingdom and Germany
2007
Eisai established in India http://eisai.com/company/profile/timeline.html
2007
Acquisition of Morphotek
2008
Acquisition of MGI PHARMA, INC.
2010
ARICEPT composition of matter patent expires in the United States 7
Eisai’s Acquisitions : Rich oncology pipeline
2007 : Acquires Morphotek US biopharmaceutical compagny
Discovery and development of monoclonal antibodies (mABs) 2008 : Acquires U.S. biopharmaceutical company MGI PHARMA, INC.
Chemotherapy Support 8
Eisai Regions
9
Corporate Objectives
Making meaningful contribution under health care system while observing the highest standards in business activities :
•
Improving Access to medicines worldwide
•
Providing Products at an Affordable Price Transformation into a high-performing company by acheving :
•
Over 7,9 billion € in net sales
• •
Over 2 billion € in operating income Over 25% operating income ratio by the year ending 31 March, 2016
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Strategies
Loss of exclusivity of Aricept® (Annual Net Sales > 3 b€) East Japan Earthquake Strategies to overcome that situation : Innovation : New Products Development
Maintaining profitability through sustainable growth in domestic business,
combined with reductions in selling, expenses Realize interaction of global and regional knowledge (expansion into New Markets) Strike a balance among investing for gross future and paying dividend and debt
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Eisai products
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Aricept® Donepezil HCl
Major product For the treatment of all stages of Alzheimer’s disease – mild, moderate and severe dementia of the Alzheimer’s type
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Aricept® Donepezil HCl
Reversible and specific inhibitor of the acetylcholinesterase
Loss of ACh caused by the death of cholinergic neurons ACh is involved in memory and learning 14
Neuroscience area
Research continue since the launch of Aricept :
- adding indications - more patients - new formulations
15 http://www.eisai.com/ir/individual/digest/point2_1.html
Neuroscience area
Insomnia treatment : Lunesta / Eszopiclone R&D on potential next-
generation Alzheimer’s disease drugs
Epilepsy treatments : Zonegran / Zonisamide Inovelon / Rufinamide Zebinix / Eslicabazepine acetate Perampanel (on developing) 16 http://www.eisai.com/ir/individual/digest/point2_1.html
Banzel® / Inovelon® Rufinamide
For adjunctive treatment of
seizures associated with Lennox-
Gastaut syndrome (LGS) in children 4 years and older and adults.
LGS is a rare form of epilepsy in which patients experience seizures of multiple types. LGS accounts for 1 to 4 percent of all childhood epilepsy cases.
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Banzel® / Inovelon® Rufinamide
Tools and Resources
http://www.banzel.com/tools-and-resources.aspx
The mechanism of action is unknown. It is presumed to
involve stabilization of the sodium channel inactive state
, effectively keeping these ion channel closed.
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Aciphex
®
/Pariet
®
Rabeprazole sodium
Aciphex is a proton pump inhibitor that reduces the amount of acid in your stomach.
Approved by FDA in 1999 • To heal acid-related damage to the lining of the esophagus (erosive esophagitis); to relieve symptoms, such as heatburn • pain.
To maintain the healing of the oesophagus and relif of • symptoms related to erosive esophagitis For the treatment of daytime and nightime heartburn and other symptoms that happen with Gastroesophageal Reflux • Disease.
For the healing and relief of duodenal ulcers 20
Aciphex
®
/Pariet
®
Rabeprazole sodium
Aciphex : Prodrug Absorption in the small intestine Systemic blood circulation Passage through the gastric parietal cell Reaction with H+ of the parietal cell (HCl) : cyclisation of the molecule Formation of cyclic sulfenamide : active forme Irreversible covalent bond with the proton pomp (ATPase H+/K+) at the SH groups of cysteines Decrases in the release of H+ increased pH 21
Oncology area
1986 : Start research for
treatments against cancer
Halaven / Eribulin for breast cancer E7080 / Lenvatinib VEGF receptor tyrosine kinase Eisai is working on developing
multiple anticancer treatments :
Therapeutic antibodies MORABb-003 / Farletuzumab 22 http://www.eisai.com/ir/individual/digest/point2_1.html
Consumer health care products
Nabolin Juvelux Chocola BB Selbelle 23 http://www.eisai.com/ir/individual/digest/point1_1.html
Eisai’s Alliance / Acquisitions History in the US
1994 : Agreement with Pfizer Inc to co promote Aricept ® 1997 : Agreement with Janssen Pharmaceuticals Inc to co-promote Aciphex ® 2002 : Acquires Cerebyx from Warner Lambert compagny
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Eisai’s Alliance / Acquisitions History in the US
2003 : Agreement with Teva Pharmaceuticals to co promote Rasagiline 2004 : Acquires anti epileptic drug Zonegran ® from Elan Corporation
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Eisai’s Alliance / Acquisitions History in the US
2006 : Acquires four oncology-related products from Ligand Pharmaceuticals
Exclusive global rights :
ONTAK ® (denileukin diftitox) TARGRETIN ® (bexarotene) Caspules & Gel 1% PANRETIN ® (alitretinoin) gel 0.1%.
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Therapeutic areas
27 http://www.eisai.com/ir/individual/digest/point2_1.html
Products supplied in 2009
32% Total sales
€7.95 billion
40% 10% 18%
http://www.eisai.com/pdf/esocial/epdf2010es.pdf
Aricept €3.20 billion Pariet €1.47 billion Oncology-related products €0.79 billion Other products €2.50 billion 28
Aricept loss of exclusivity strategy
2010 2011 2012 2013 LOE in US (mild to moderate AD) LOE in EU & Japan (mild to moderate AD) LOE of Pariet in Europe LOE of AcipHex in US
29 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Aricept loss of exclusivity strategy New indications and formulations
New higher dose : Aricept 23 mg tablet => launched in August 2010 in the US => 2014 in Japan Weekly transdermal patch formulation => On evaluation Pediatric indication in US and Europe => On evaluation 30 http://www.eisai.com/news/news200924.html
: Current Status of the Development Programs of New Indications and Formulations of Aricept® for Enhancing Patient Value
Products supplied by EISAI
Sales (billion €)
8,00 7,00 6,00 5,00
7.95
4,00 3,00 2,00 1,00 0,00 2009 http://www.eisai.com/pdf/esocial/epdf2012es.pdf
2010
7.61
6.42
2011 Other products Oncology-related products Humira Pariet Aricept 31
Mid term strategic Plan « Hayabusa »
ERA OF TRANSFORMATION
32 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Roadmap for the Plan « Hayabusa »
Embarked on from April 2011
7,61 b € 1,15 b € 33 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Roadmap for the Plan « Hayabusa »
Embarked on from April 2011 Increase Net Sales OP margin at 25%
Aim for 7.9 b € + 7,61 b € 2.0 b € + 1,15 b € 34 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Global Access
120 100 80 60 40 20 0 FY2006-10 2 10 6 3
66
23
Number of countries Served by EISAI products
2 10 12
114
13 37 40 22 North America Middle East Central / South America Africa Europe Asia / Oceania FY2011-15
5-year cumulative number of patients served by EISAI Products
(Million)
200+ 500+
FY2011-15 FY2006-10 (Internal estimates) 35 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Human Health Care
36 Annual report 2012
Human Health Care
Affordability
Providing medicines at affordable prices suitable to the social, economic and healthcare environments of individual countries.
Aricept ®
INDIA
: remains the leading brand. Price : 90 % less than in Japon.
Free pamphlets and provides training and education for the medical staff.
PHILIPPINES
: Affordable pricing to Revovir® (Clevudine) for chronic hepatits B.
Exclusive rights to develop, market and manufacture
INDONESIA
: The price of Aricept® was revised. Sales x4 in 2 years.
Support program to raise local awareness and improve compliance.
37 Annual report 2012
Human Health Care
Availability
The Group utilizes the Eisai Knowledge Centre / Vizag Plant in India strategically to supply high-quality medicines at competitive prices.
30 tons of API - 2 billion tablets per year
Manufacturing and supplying API for products
in emerging and developing countries.
API process research for the next generation of Eisai’s global products 38 Annual report 2012
Human Health Care
Availability Development of a New Drug for Chagas Disease
License agreement with the non-profit independent foundation, Drugs for Neglected Diseases initiative (DNDi)
DNDi Eisai
Responsible for assessment Scientific expertise Supply drug for the clinical studies Manufacture, register and make available the product 39 Annual report 2012
Human Health Care
Adoption Support for the Program to Eliminate Lymphatic Filariasis
International public-private partnership with the aim of investing long term to bring a “zero price” model for providing medicine to reality.
Eisai : 2.2 billion tablets of diethylcarbamazine free of charge
through 2020.
40 Annual report 2012
Global Access
120 100 80 60 40 20 0 FY2006-10 2 10 6 3
66
23
Number of countries Served by EISAI products
2 10 12
114
13 37 40 22 North America Middle East Central / South America Africa Europe Asia / Oceania FY2011-15
5-year cumulative number of patients served by EISAI Products
(Million)
200+ 500+
FY2011-15 FY2006-10 (Internal estimates) 41 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Entries to all top 20 countries in next 5 years
http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
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Make use of significant growth opportunity in pharmamerging
China CAGR * = 22.4%
* Compound Annual Growth Rate • • Announced the direction of healthcare reform including shift to provide national
insurance coverage by 2020 (Apr. 2009)
Revision of National Reimbursement Drug List (Nov.2009) • New government to enhance access to medicine and pharmaceuticals (30% increase in government health care spending)
India CAGR * = 14.8%
* Compound Annual Growth Rate http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Brazil CAGR * = 10.5%
* Compound Annual Growth Rate • Prime Minister sets up expert committee to
propose action for universal health
coverage in India (Oct.2010) 43
Revenue announcement
9 8 7 6% 6 5 4 40% 1% 3 2 1 0 2010 49%
Revenue by Region (Billion €)
2011 2012 2013 2014 7% 23% 4% 63% 2015 Others Europe
US
Emerging / New Mkts
East Asia
(China CAGR 26%) 44 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Roadmap for the Plan « Hayabusa »
Increase Net Sales
Global Access
Aim for 7.9 b € + 7,61 b € 2.0 b € + 1,15 b €
OP margin at 25%
?
45 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Roadmap for the Plan « Hayabusa »
Structural transformation Increase Net Sales
Aim for 7.9 b € + 7,61 b € 2.0 b € + 1,15 b €
OP margin at 25%
?
46 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Structural Transformation
Environmental_and_social_report_2010, EISAI
5 Regions
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Structural Transformation
The Americas
(North, Central and South America)
• Effective and efficient sharing of business resources (knowledge and experience) developed in the U.S. with Canada and Latin
America
• Utilization of U.S. CPP (Certificate of Pharmaceutical Product)
for regulatory submissions in Latin American countries
• Mexico functions as a major hub of other Spanishspeaking Latin American countries
CAGR (fiscal 2011 to fiscal 2015) : 7%
48 EISAI annual report 2012
Structural Transformation
Environmental_and_social_report_2010, EISAI
5 Regions
49
Structural Transformation
EMEA (Europe/the Middle East/Africa) CAGR (fiscal 2011 to fiscal 2015) : 5%
• Transmission of medical and marketing knowledge • Utilize the EU regulatory dossier for regulatory submissions
among countries in the EMEA region
Indo-Pacific
(South Asia, ASEAN countries, and Oceania) CAGR (fiscal 2011 to fiscal 2015) : 11%
• Interactive knowledge sharing in the IndoPacific region • Introduce a range of brand name prescription pharmaceuticals and branded generics.
50 EISAI annual report 2012 & plan Hayabuza
Structural Transformation
Environmental_and_social_report_2010, EISAI
5 Regions
51
Ressource Optimization
Launch of Eisai East Asia Japan Korea China Taiwan Hong Kong
• Implementation of exchange programs involving front-line sales staff and exchange programs for physicians in the region • Promotion of mutual understanding through the interaction
of key opinion leaders in Japan and China
• Outward transmission of hhc knowledge accumulated in
Japan to the region
52 EISAI annual report 2012
Japan
Ressource Optimization
Launch of Eisai East Asia Korea Taiwan Hong Kong China Major growth driver for the Eisai Group CAGR (fiscal 2011 to fiscal 2015) : 11%
53 EISAI annual report 2012
Structural optimization
4 Regions Extension Interactive knowledge sharing
EISAI annual report 2012
Regroupment
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Headcounts Reduction
3b€ United States 1.8b€
2010 2015
Transform from mass market/co-promotion model to independent neuroscience/oncology franchise model
•
Focus on women’s oncology
, or the treatment of cancers that primarily affect women, and accelerate the transformation of this therapeutic franchise • Further enrich neuroscience franchise with
epilepsy product line addition of Headcounts from under 1,600 to 1,000+
EISAI annual report 2012 & plan HAYABUZA 55
Roadmap for the Plan « Hayabusa »
Increase Net Sales
New Princeps
Aim for 7.9 b € + 7,61 b €
?
1,15 b €
OP margin at 25%
56 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Optimization of R&D
Product Creation Units (PCUs) 6 Discovery Area
Neuroscience PCU Oncology PCU Morphotek PCU Frontier PCU KAN PCU Japan/Asia Clinical Reasearch PCU
Chief Product Creation Officer (CPCO)
Collaboration
Core Function Units (CFUs) 6 Technology & Function Area Pharmaceutical science & Technology CFU Biomarkers & Personalized Medecine CFU Scientific & Operational Clinical Support CFU Next Generation Systems CFU Biopharmaceutical Assessments CFU
Global Regulatory Affairs CFU
Chief Scientific Officer (CSO)
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Aims of specific R&D structure
To ensure up-to-date information from all sources.
To decrease time consuming on the research.
To facilitate decision making and enhances R&D success.
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300 250 200 150 100 50 0
Top 25 companies by pipeline size 2011
Number of R&D products Number of originated products
17 th
59
Investigator Initiated Studies IIS Research grants Clinical supplies Funding to eligible applicants
Aim : support scientifically compelling and innovative research 60 http://www.eisaigrants.com/docs/Getting%20Started%20(IIS).pdf
Neurology
9 products Fycompa Phase I Phase II Phase III • Partial-onset seizures (Additional indication) • JP/CN/AS Phase III Aricept Inoveron / BANZEL / E2080 • Severe Alzheimer’s disease (Additional Indication) • JP Phase III • Pediatric Lennox-Gastaut syndrome (Additional Indication) • US/EU Phase III Approved AS-3201 • Diabetic neuropathy • US/EU Phase II/III Fycompa • Pediatric partial-onset seizures(Additional Indication) • US/EU Phase II 61 http://www.eisai.com/pdf/eir/erepo/epipeline.pdf
Vascular and Immunological Reaction
6 products E5501 Phase I Phase II • Idiopathic thrombocytopenic purpura • US/EU/AS Phase III Phase III Approved E5564 • Severe sepsis • JP/US/EU Phase III E5501 • Thrombocytopenia in chronic liver disease requiring surgery • US Phase II E6201 • Psoriasis • US/EU Phase II E6005 • Atopic dermatitis • JP Phase II 62 http://www.eisai.com/pdf/eir/erepo/epipeline.pdf
Gastrointestinal and Hepatic Disorders
Phase I Phase II Phase III Approved Pariet • • Prevention of recurrence of gastric and duodenal ulcers during treatment with low-dosage aspirin – ADDITIONAL INDICATION JP Phase II/III Pariet • Functional dyspepsia – ADDITIONAL INDICATION • JP Phase II 63 http://www.eisai.com/pdf/eir/erepo/epipeline.pdf
Oncology and Supportive Care
21 Products
8 for an Additional Indication 6 products in phase 3 14 products in phase 2 1 product in phase 1/2 64 http://www.eisai.com/pdf/eir/erepo/epipeline.pdf
Oncology and Supportive Care
E7040 Phase I Phase II Phase III • • Transcatheter arterial embolization of hypervascular tumors JP Phase III Approved Halaven MORAb-003 • Second-line treatment for breast cancer – Non small cell lung cancer - Sarcoma • JP/US/EU/AS Phase III • Approved in Japan (april 2011) & Switzerland (may 2011) • Platinum-sensitive ovarian cancer • JP/US/EU/AS Phase III MORAb-003 • Non-small cell lung cancer • US/EU Phase II MORAb-004 • • Melanoma – Colorectal cancer - Sarcoma US/EU Phase II E7080 • • Endometrial cancer – Melanoma – Glioma – Non-small cell lung cancer US/EU Phase II 65 http://www.eisai.com/pdf/eir/erepo/epipeline.pdf
Innovation 7 Major NMEs expected to be launched
HALAVEN Microtubule dynamics inhibitor Cancer LENVATINIB VEGF-R multi target Tyrosine kinase inhibitor Cancer FARLETUZUMAB IgG1 that targets folate receptor alpha (FRA) Cancer PERAMPANEL AMPA receptor antagonist CLEVUDINE DNA polymerase inhibitor Epilepsy Hepatitis B LORCASERIN 5HT2C receptor agonist
AVATROMBOPAG
Obesity Thrombopoietin receptor agonist ITP
66 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Halaven®
1986 : Discovery of Halichondrin B from marine sponge 1992 : Preclinical studies (high cytotoxic effects) 1998 : Development of complete synthetic method by Dr Yoshiro Kishi 2002: National Cancer Institute started Phases I study 2003: Eisai opened additional Phase I trials 2004: Phase II trials began 2006: Phase III trial of eribulin
67
www.halaven.com
EMBRACE Phase III trial
Halaven®
www.halaven.com
EMBRACE Phase III trial
Halaven®
Revenue announcement
Revenue by Franchise (Billion €)
9 8 7 24% 6 5 3% 18% 4 3 10% 7% 2 1 38% 0 2010 2011 2012 2013 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
2014 27% 4% 9% 22% 22% 16% 2015
LORCASERIN AVATROMBOPAG
Others
CLEVUDINE
GI / liver Oncology Pariet®
HALAVEN LENVATINIB FARLETUZUMAB
Epilepsy, etc.
Neuroscience Aricept®
PERAMPANEL
71
(million €) 800 600 400 200 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
Goals
Top three epilepsy player
72
Revenue announcement
Revenue by Franchise (Billion €)
9 8 7 24% 6 5 3% 18% 4 3 10% 7% 2 1 38% 0 2010 2011 2012 2013 http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
2014 27% 4% 9% 22% 22% 16% 2015
LORCASERIN AVATROMBOPAG
Others
CLEVUDINE
GI / liver Oncology Pariet®
HALAVEN LENVATINIB FARLETUZUMAB
Epilepsy, etc.
Neuroscience Aricept®
PERAMPANEL
73
Goals
Top 3 position in women’s Oncology Top 10 Oncology Player
10/01/2013 : « Farletuzumab did not meet the study’s primary endpoint » 74 http://www.morphotek.com/news-events/News-Archive/2013-News/Morphotek-Announces-Top-Line-Results-of-A-Phase-II.aspx
Development of disease modifiers
Phase I for Alzheimer disease http://www.eisai.com/pdf/eir/emat/4523_110304e.pdf
75
Financial analysis
76
Billion €
Net sales
Net sales (billions of euros)
9 8 7 2 1 0 6 5 4 3 Exchange rate at 12 November 2012 : 1 euro = 100.982 ¥ Net sales (billions of euros) Annual report 2012 77
Net sales 2010
0,49 b € 0,39 b € 0,44 billions €
Net sales
3 billions € 3,47 billions € Japon (44,53 %) North America (38,51 %) Europe (5,65 %) ASEAN (5 %) Others (6,29 %)
Net sales 2011
0,4 b € 0,41 b € 0,42 billions € 1,56 billions € 3,97 billions € Exchange rate at 12 November 2012 : 1 euro = 100.982 ¥ Japon (58,73 %) North America (23,08 %) Europe (6,21 %) ASEAN (6,06 %) Others (5,92 %) Annual report 2012 78
Gross Profit
3 2 1 0 9 8 5 4 7 6 Million € 2008 2009 2010 Exchange rate at 12 November 2012 : 1 euro = 100.982 ¥ 2011 Net sales Cost of sales Gross profit 79
Net income VS R&D
2500 Million € 2000 1500 1000 500 Acquisition U.S. biopharmaceutical company Morphotek & MGI PHARMA, INC 0 -500 Exchange rate at 12 November 2012 : 1 euro = 100.982 ¥ Net income R&D expenses 80
-2 -4 2 0 10 8 6 4
ROA (%)
TorreyPines Therapeutics Inc.
ROA (%) 81
ROE (%)
20 15 10 5 0 -5 ROE (%) Return of equity : Which measures how effectively a compagny is able to produce a profit with the money invested by shareholders 82
Shareholder’s equity
Billion €
Equity
1 0 3 2 6 5 4 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 83
Dividends
84
Foreign tax credits and dividends of foreign branches
Foreigners credit paid directly by a Japanese company on income gained out of the nation.
Credits taxes specially reduced in a country in the term of fiscal agreement. Exclusion of foreign dividend.
85 http://www.jetro.go.jp/fr/invest/setting_up/laws/section3/page9.html
Top 10 Shareholders*
(as of March 31, 2012) 86
Share Price
To
kyo stock
P
rice
I
nde
X
87
EBITDA
Billion € 1,8 1,6 1,4 1,2 1 - 8,6% 6,4% - 6,8% - 8,0% 0,8 0,6 - 2,6% 0,4 0,2 0 2007 2008 2009 2010 2011 2012 2013 2014 2015 Expected EBITDA Published EBITDA
88
SWOT - Strengths
Contributing to a variety of patients in the Neuroscience area Multiple approaches for Cancer treatments Acquisition of MGI Pharma strengthning Eisai’s presence in growing US oncology market Consumer oriented approach to Product improvement and information provision Eisai’s Key product patent
89
SWOT - Weaknesses
Several « Dramatic Lead Plans » Setbacks in obtaining regulatory approvals limiting drug candidates’ commercial potential
90
SWOT - Opportunities
Enhancing footprint in European and emerging markets could help Eisai offset sales decline in US Integrating Morphotek R&D capabilities could bring potential biologics to Eisai New solutions, developing drug uickly and getting them to the market Belviq®
91
SWOT - Threats
Healthcare reforms in Japan could affect Eisai’s domestic sales growth Mature product portfolio facing generic erosion Patent expiration of key drivers products Globalization with intensified market competition
92
Thank you for your attention
93