20110111_en
TRANSCRIPT
Astellas Growth Strategy-Leveraging Our Strengths to Grow-
Masafumi NogimoriPresident & CEOAstellas Pharma Inc.
J.P. Morgan HealthCare ConferenceJanuary 2011
Target figures in this material are not forecasts of business results. In addition, any description relating to the future in this material is subject to known or unknown risks and uncertainties, although it is based on management’s current assumptions and beliefs in light of the information currently available to it. Please be cautioned that a number of important factors could cause actual results to differ significantly from the description in the material.
Such risks and uncertainties include adverse economic conditions, currency exchange rate fluctuations, adverse legislative and regulatory developments, delays in new product launch, pricing and product initiatives of competitors, the inability of the company to market existing and new products effectively, interruptions in production, infringements of the company’s intellectual property rights and the adverse outcome of material litigation.
This material contains information on pharmaceuticals (including compounds under development), but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations nor provide medical advice of any kind.
Cautionary statement regarding forward-looking information
3
Business Model of Astellas
VISION 2015で掲げた指針・目標を継続するConcentration on Proprietary
Ethical Pharmaceutical Business
新薬ビジネス
Establish a competitive edge as a Global Category Leader (GCL)
A “GCL” shows higher competitiveness by providing value-added products ‘globally’ in several ‘categories’where a high degree of expertise is required. And takes over the position of ‘leader’ in the categories
Strengthen In-house R&D capabilities
Concentrate proprietary ethical pharmaceutical business Innovative
pharmaceutical business approach
Proprietary ethical pharmaceuticalbusiness approach
Landing of Science
Landing of Science
H2 receptor antagonists Beta receptor blockers etc.
HMG-CoA
Nucleic acid drugs
Molecularly-targeted drugs
Antibodies etc.
Current Market
Tissue engineering(ES cell, iPS cell, Somatic cell )
System biologyPharmacogenomics ToxicogenomicsDeciphering the human genome
Drug discovery research utilizing drug target moleculeand disease related gene (HTS, structural biology, CADD)DNA recombination technology
PCR
Technology innovation sustaining drug discovery
NSAIDs etc.Market Size
Drug Discovery and Science Progress
4
~1950 1950~1990 latter half
Pharmaceutical market grew as science progresses
Future Market
Current GCL Area and Future GCL Candidates
Establish a GCL model in the five focus therapeutic areas utilizing multiple NME platforms
Current GCL areas Future GCL candidates
Oncology
Neuroscience
DM Complications & Metabolic Diseases
Immunology & Infectious
DiseasesTransplantationUrology
Small molecule synthesis
NME platform
Fermentation Antibody Protein
NME platform
6
Actively Approach to Precision Medicine Drug Discovery
Astellas aims to establish a leading position in Precision Medicineby leveraging translational science and biomarker research
“One-size fits all” prescription
Past
Highly effective drugs for defined patients
Future
Higher efficacy and fewer side effectsSmaller-scale clinical trials targeting specific population of patientsPharmacoeconomical advantages by prescribing for responders only
Precision Medicine:Offering highly effective therapeutic options for precisely defined patient populations based on molecular targeting and precise diagnosis
Mass Medicine Precision Medicine
7
FY2010-FY2014 Mid-term Management Plan- Basic Policy and Strategy
長期成長
Growth strategy• Therapeutic area strategy
• Regional strategy
• R&D innovation strategy
Efficiency strategy• Improve cost efficiency
Overcome decrease in sales and earnings from U.S. patent expiry of Prograf and Harnal and accelerate growth to a new stage
8
Transplantation :Maintain and Reinforce Global Leading Position
n ASKP1240 P2 (US), P1(JP)Antibody- CD40 antagonistic monoclonal antibody
n ASP0485 P2 (EU/US)Protein
- LFA3-IgG fusion protein
n ASP015K P2 (US), P1 (JP)Small molecule
- Immunosuppressant
20%
13%
29%
38%FY2009 FY2010
ForecastFY2014 Target
JapanEurope
AsiaAmericas
Over 160.0*154.7
186.7(billion yen)
Maintain and Maximize Prograf Business
Suppression of Organ rejection in organ transplant
Prevention of DGF in Kidney transplant
n Diannexin P2 (EU/US)Protein-Phosphatidylserine binding inhibition
Unique Candidates in Clinical Phase
Aim to contribute further to the transplantation community
*Revised sales target which was announced in May, 2010 due to revise expected FX rate.
9
Urology:Maximize Global Sales
20%
13%
29%
38%
154.1
Growth Driver :Vesicare and Mirabegron
Vesicare
Over 215.0 *
BPHOAB
(billion yen)
Over 155.0
FY2010Forecast
FY2014Target
Strengthen Global Leading Position in OAB
Vesicare+Mirabegron
89.5
Harnal/Omnic
OABn Vesicare OD Approval (JP) LCM of Vesicare n ASP3652 P1 NME
BPH n EC905 P3(EU) LCM of Harnal
/Vesicaren AKP0306 P1 NMEn AKP-002 P1 NME
Nocturian ASP7035 P1
Mirabegron NDA filing Japan: June, 2010 US/EU: 2Q/ FY2011
Harnal/Omnic+EC905
*Revised sales target which was announced in May, 2010 due to revise expected FX rate.
64.6Approx.60.0
Maximize Global Sales in OAB and BPH
LCM and NME Candidatesin Clinical Phase
Aim for continuous high sales growth
October 2010Submit NDA of Degarelix
June 2010Acquisition of OSI-Acquire fully integratedoncology capabilities in the U.S. -Expand clinical stage oncologypipeline
-Access to small molecule discovery research platform in oncologyDecember 2009
AC220 (AML)Licensed fromAmbit
October 2009MDV3100 (Prostate cancer)Licensed from Medivation
December 2007Acquisition of Agensys-Generation of fully human monoclonalantibodies
-Gain target molecules in the oncology field
-Therapeutic antibodies in R&D pipeline
Oncology:Reinforcement of Oncology Business Base
Select “oncology” as a focus therapeutic areaPromote in-house research system(Initiate antibody research headed by Molecular Medicine Research Labs.)
March 2007 MorphoSys: Phage antibody library
March 2007 Regeneron: VelocImmuneⓇ generating fully human monoclonal antibodies
2006 2010
July 2010Extend license agreement
Oncology Pipeline ExpansionProject
Product name Target cancer P1 P2 P3 Filing
Small molecule
MDV3100 Prostate cancer EU/USA/JP
AC220 Acute myeloid leukemia EU/USA
ASP3550degarelix Prostate cancer 1M formulation: JP
3M: JP
YM155 Breast cancer, Non-Hodgkin's lymphoma, Melanoma EU/USA/JP
ASP1707 Prostate cancer, Endometriosis
Tarceva (Extension)
NSCLC (1st line for patients with EGFR mutation, adjuvant), Hepatocellular carcinoma USA
OSI-906 Adrenocortical carcinoma, Ovarian cancer, NSCLC, Hepatocellular carcinoma
Adrenocortical: USAOvarian etc: USA
OSI-027 Renal cell cancer
Antibody
AGS-1C4D4 Pancreatic cancer EU/USAASP6183
(AGS-8M4) Ovarian cancer USA
AGS-16M18 Cancer
AGS-16M8F Renal cancer
ASG-5ME Prostate cancer, Pancreatic cancer11
* Development suspended
OSI
OSI
OSI
12
Achieved many alliances that have helped bolster the pipeline and products
Qutenza Peripheral neuropathic pain
in non-diabetic adults
VIBATIV cSSTI: Complicated Skin and Soft Tissue Infection
telavancinHAP: Hospital-acquired
Pneumonia
ASP8825(XP13512)
Restless legs syndrome
GeninaxOral quinolone antibiotic
Degarelix Prostate cancer
AmevivePsoriasis
YM311 ASP1517 etc.(FG-2216 FG-4592, etc.)
Renal anemia
ASP1585(AMG223)
Hyperphosphatemia
CD40 antagonistic monoclonal antibody
Transplantation
CTS-21166, etc.Alzheimer's disease
MAXY-4Transplantation,
rheumatoid arthritis and otherautoimmune diseases
febuxostatHyperuricemia in gout
Sumavel DosePro Acute treatment of migraine
and cluster headache episodes
Caduet Combination TabletsHypercholesterolemia and
hypertension treatment
Symbicort TurbuhalerTreatment of
adult bronchial asthmaMDV3100
Prostate cancerLinaclotide
IBS and chronic constipation
AC220Acute myeloid leukemia
IsavuconazoleFungal infections
Joint venturewith Maxygen
Licensed in Regeneron ’sVelocImmune technology
Utilizing MorphoSys AG’s antibody library
Agensysacquisition
Strengthened antibody drug business
Seattle Genetics and Agensys Expand
antibody-drug conjugate (ADC) collaboration
Alliance Achievements Between FY2005 and FY2010
Technology in-licensing
FY2005 FY2006 FY2007 FY2008 FY2009 FY2010UMN-0501/-0502
Influenza
AKP-002Functional symptoms
of benign prostate hyperplasia
DiannexinPrevention of DGF
in kidney transplantation
Regeneron ’sVelocImmune technology
Extension of license agreement
Strategic equity agreement with Cytori
Technology in-licensing
OSIacquisition
Technology in-licensing
: In-house global :Local, licensed-in, new Indication, or new formulation
MDV3100 (JP)AGS-16M18AGS-16M8FASG-5MEYM155 (JP)ASP1707
Oncology
ASP0777FK949ECNS
telavancin (JP)Anti-
Infective
ASKP1240 (JP)ASP015K (JP)ASP3291ASP4058
TransplantImmunologyInflammation
P2
ASP0456Others
YM311 (JP)#ASP1517 (JP) #ASP4178ASP5034
DiabetesCardiologyRenal
ASP3652, ASP7035ASP0306, AKP-002Urology
P1P3Filed
ASP8825 (Restless legs syndrome, JP)
YM177 (Acute pain, JP)
ASP1585 (Hyperliphosphatemia, JP)
YM178 (OAB, EU/USA)
YM150 (VTE, JP)
solifenacin/tamuslosin (EU)
YM529 (1M, JP)YM443 (FD, JP)
telavancin (NP, USA)
RSD1235 (AF, USA)
ASP0485 (Transplant, EU/USA)
ASP9831 (Hepatitis, EU)ASP015K (Transplant, USA)
ASP3550 (1M, JP)
telavancin (cSSTI/NP, EU)
ASP1941 (DM, JP) YM150 (VTE:EU/USA, AF:EU/JP/Asia, ACS:EU)
YM311 (USA), ASP1517 (USA)#
ASP1941 (EU/US)YM533 (Chronic renal failure, JP/Asia)
ASP2151* (USA/JP)
ASKP1240 (Transplant, USA)
isavuconazole (Aspergillosis, candidemia, EU/USA)
YM178 (OAB, JP)
YM060 (IBS, EU)YM060 (IBS Female, JP)
MDV3100 (EU/USA)
elrotinib (USA)
OSI-906 (Adrenocortical, USA)
YM155 (EU/USA)
AGS-1C4D4 (EU/USA)AC220 (EU/USA)
ASP6183* (AGS-8M4) (USA)ASP3550 (3M, JP)
YM905 (Pediatric, EU/USA)
Diannexin (DGF, USA)
PSN821 (Diabetes, obesity, USA)
*Development suspended, # Licensed territory: EU and JP etc.,
OSI-027(USA)
Robust Pipeline
OSI-906 (Ovarian, USA)
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Well-Balanced Business Expansion in 4 Regions
179.8 billion yen18.4%
Americans
Consolidated Net Sales(FY2009):974.8 billion yen
529.2 billion yen54.3%235.8 billion yen
24.2%
29.9 billion yen3.1%
Europe
Japan
Group HQ/Regional HQ
Sales Affiliate/Promotion Base (EUR)
R&D Base
Manufacturing Base
5,600 MRsSales through own affiliatesin more than 40 countriesWide coverage including emerging countries such as BRICs
Sales by Geographical Areas (FY2009)
Asia
Strength for Each Area
15
Americas
nBusiness model focused on specialty areasnSales affiliates
in USA, Canadaand Brazil
nRealize high growth by expanding sales in each country nMain Asia market cover
-Sales affiliates in 8 countries/areas
nNo.1 sales among Japanese pharmaceutical companies*n Extensive geographic coverage
-20 sales affiliates/9 promotion offices
n Top ranked sales forcen Rich product lineup
(Therapeutic areas and product numbers)
*Copyright 2010 IMS health. All rights reserved. Source: World Review Preview 2010 (2009 YR) Reprinted with permission.
Japan
Asia
Americas
Europe
Europe
Growth Drivers for Each Area
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Japan Americasn Vesicare n Lexiscann Mycaminen Protopicn VIBATIVn Sumavel DosePron Tarceva revenue
n Prografn Harnaln Vesicaren Mycaminen Protopic
n Vesicaren Prografn Micardis family
(Micombi, Micamulo)n Celecoxn Geninax n Symbicortn Bonoteon Irribow
n Vesicaren Eligardn Mycaminen Protopicn Qutenza n Bendamstine royalty income
Asia
Business Expansion in Emerging CountriesExpect High growth
Europe
n Russia -Established the affiliate in 1994
• High growth rate (2Q/FY10 +42%)• The 5th largest sales among
European countries • Further expanding in CIS
n Brazil -Established the affiliate in 2009 -Expect high sales growth
Americas
17
n India-Established the affiliate in
2008
n Expanding intoother countries
n China -Established the affiliate in 1994
• High growth rate (2Q/FY10 +19%)• Aim for sales of more than double of
FY2010 in FY2014• Increase MRs to expand customer
coverage• No.1 in sales among Japanese Companies
Brazil
n Turkey / Poland- High growth rate (2Q/FY10 +30%)
n Romania/Bulgaria-Recent Regal entity for promotion
n Expanding into other countries
(Source: IMS MIDAS®, CY2009.3QYTD)
ブラジル
FY2010Forecast
FY2009
China
Russia
China
Russia
Brazil
Approx. 30 billion yen
Asia
18
Growth Realization to FY2014
Continuous growth in both net sales and operating income after FY2010
Symbicort (JP)Bonoteo(JP)
Qutenza (EU)Sumavel
DosePro (US)VIBATIV (US)
FY2009 New Products
ASP8825 (JP)
Launches
Mirabegron (JP/US/EU)
Launches
Japan New Product Lineup (Degarelix, YM150VTE,
YM529, YM443, ASP1585)telavancin (EU)
EC905 (EU)
LaunchesMDV3100 (US,EU)
ASP1941 (JP)RSD1235 (US)AC220 (EU,US)
isavuconazole (EU,US)
Launches
910.9
OSI ImpactSales +56.0 OP +5.0
FY2010 FY2011 FY2012 FY2013FY2014
FY2010 Forecast
Sales 942.0 OP 124.0
(billion yen)
FY2014 Target
Sales 1,096.0 OP 226.0
(billion yen)
OSI ImpactSales +31.0 OP -11.0
FY2014
19
Further strengthen the orientation to patients and make the best efforts to meet unmet medical needs for
patients all over the world.