japan's new growth strategy: msd’s contribution as a ... › wp-content › uploads › 2011 ›...
TRANSCRIPT
-
Japan's New Growth Strategy:MSD’s Contribution as a Global Company
Presentation at Pharma Delegates
Tony AlvarezRepresentative Director and President
MSD K.K.January 20, 2011
-
2 Tony Alvarez @ Pharma Delegates 012011
Forward-Looking StatementMerck & Co., Inc., Whitehouse Station, N.J., U.S.A.
This presentation contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2009, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
-
3 Tony Alvarez @ Pharma Delegates 012011
No Duty to Update
The information contained in the presentation set forth below was current as of December 29, 2010. While this presentation remains on the company’s website the company assumes no duty to update the information to reflect subsequent developments. Consequently, the company will not update the information contained in the presentation and investors should not rely upon the information as current oraccurate after December 29, 2010.
-
4 Tony Alvarez @ Pharma Delegates 012011
Agenda
New MSD
New MSD: A compelling combination1 Introduction of New MSD
2 Japan’s New Growth Strategy 2010
3 MSD’s Global Contributions toJapan’s Growth through Innovation
-
5 Tony Alvarez @ Pharma Delegates 012011
Agenda
New MSD
New MSD: A compelling combination1 Introduction of New MSD
2 Japan’s New Growth Strategy 2010
3MSD’s Global Contributions to Japan’s Growth through Innovation
-
6 Tony Alvarez @ Pharma Delegates 012011
► Approximately 93,000 employees around the world
► Operations in more than 140 nations
► Scientists committed to finding the best science globally, and accessing a great diversity of scientific thought
► 2010 Revenues (Jan.-Sep.) : $33.9 billion
► 2009 R&D Expense: $5.8 billion
Today’s MSD: Expanded Global Presence
-
7 Tony Alvarez @ Pharma Delegates 012011
7
A Diverse Portfolio and Global Presence1Q - 3Q 2010 Pharma & Vaccines Revenue¹1Q - 3Q2010 Total Revenue
Japan9%
Latin America7%
Canada4%
EasternEurope/Middle East Africa
4%
Other0%
Asia Pacific6%
Europe27%
United States42%
Animal Health6%
ConsumerHealth
3%
Other4%
Neuro & Ophth3%
InfectiousDisease
10%
Oncology5%
Women'sHealth
4%
Diabetes8%
Vaccines9%
DiversiliedBrands
11%
Bone, Resp,Immun & Derm
25%
Cardiovascular10%
¹ Excludes $38 million of other sales in 1Q 2010
-
8 Tony Alvarez @ Pharma Delegates 012011
Animal Health ConsumerHealth Care
Emerging Markets Vaccines
ComplementaryBusinesses
Focused Integrated Effort on Greatest
Growth Opportunities
Cardiovascular Diabetes/Obesity
Bone/ImmunologyRespiratory/Dermatology
Expanded and Strengthened
Franchises
Oncology Neurosciences/Ophthalmology
Women’s Health/
EndocrineMature Brands
Infectious Diseases
Biologics
Positioned to Capitalize on Growth Opportunities & Combined Strengths
-
9 Tony Alvarez @ Pharma Delegates 012011
9
CV andDiabetes
Infectious Diseases
Respiratory/ Bone/
Imm/Derm
Women’s Health
Neuro/Ophthalmology
Oncology
Vaccines
Mature Brands
Best Positioned to Offer Customers a Portfolio of Options in Key Therapeutic Areas
-
10 Tony Alvarez @ Pharma Delegates 012011
Financial strengthto invest in the best opportunities in healthcare
Merck* and Schering-Plough: A Compelling Combination
Strong & diverse portfoliowith leading brands in key businesses
Powerful late-stage pipelinewith more than 20 late-stage compounds in global
Expanded global focuswith a greater proportion of sales outside the U.S. and a dedicated strategy for emerging markets
*Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
-
11 Tony Alvarez @ Pharma Delegates 012011
MSD Started in Japan on October 1, 2010
Expanded product portfolio
Increased market presence
Diverse and robust pipeline
Banyu Pharmaceutical Co., Ltd.
x
Schering-Plough K.K.
-
12 Tony Alvarez @ Pharma Delegates 012011
Our Company’s Origin in Japan…
Established in 1891Founder: George Merck23 years oldat that time
1891 Founded Merck in New York
1915 First Merck Research Laboratory in Rahway, NJ- Sulfas- Antibiotics- Hormones, etc.
1930s Established framework for scientific research cooperation with universities
Merck & Co., Inc.,Whitehouse Station, N.J., U.S.A.
Established in 1915Founder: Toru Iwadare 26 years oldat that time
1915 Synthesizing and mass-producing SalvarsanFounded Banyu during post-graduate at University of Tokyo
1946 Developed penicillin (first in Japan)
Schering-Plough K.K.
1959 Established in Japan under the name of Essex Nippon(renamed to Schering-Plough K.K. in 1989)
1960 Nippon Organon K.K. was founded(was merged by S-P K.K. in 2008)
Banyu Pharmaceutical Co., Inc.
-
13 Tony Alvarez @ Pharma Delegates 012011
MSD: Increased Scale
Tokyo Head Office
Menuma Plant
Shiga PlantOsaka Office
• Approximately 4,400 employees
• Approximately 2,400 MRs
• 15 nationalities• Capital:Y26,349 million (As of October 1, 2010)
-
14 Tony Alvarez @ Pharma Delegates 012011
2009 FYRanking Company
2009 FYSalesBillion
Yen
2010 FYRanking Company
2010 FYSalesBillion
YenETHICAL TOTAL 8,852 ETHICAL TOTAL 8,874
1 TAKEDA YAKUHIN KOG 531 1 TAKEDA YAKUHIN KOG 5372 DAIICHI SANKYO 492 2 PFIZER 5203 PFIZER 472 3 DAIICHI SANKYO 4704 CHUGAI SEIYAKU 423 4 MITSUBISHI TANABE 3935 MITSUBISHI TANABE 401 5 CHUGAI SEIYAKU 3926 NOVARTIS PHARMA
-
15 Tony Alvarez @ Pharma Delegates 012011
Continuous Growth Through Delivering Innovative Medicines & Vaccines to Japan
0
50
100
150
200
250
300
350
400
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Banyu and Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.Integration
Banyu & SPKKIntegration
Claritin®, Qvar®Claritin®, Qvar®
Rebetol®Rebetol®
PegIntron®Claritin® Reditab®
PegIntron®Claritin® Reditab®
Nulotan®Nulotan®
Preminent®Preminent®
Propecia®Propecia®
Eyevinal®Eyevinal®
Trusopt®Trusopt®
Singulair®, Fosamac®Singulair®, Fosamac®
PegIntron®, OthersPegIntron®, Others
Temodal®Temodal®Zetia®Zetia®
Claritin® DS, Nasonex®,Aroglycem® Follistim® Pen
Claritin® DS, Nasonex®,Aroglycem® Follistim® Pen Remeron®
Asmanex®Ganirest®
Remeron®Asmanex®Ganirest®
Isentress®Isentress®
Januvia®Januvia®
Sales in SPKK Sales in Banyu
(Bill
ion
yen,
NH
I Bas
is fr
om IM
S)
-
16 Tony Alvarez @ Pharma Delegates 012011
Cardio /Metabolic
Infectious Disease/ Vaccine
Respiratory
Therapeutic Area
MSD: Expanded Japan Product PortfolioLegacy Banyu Products
Dermatology
Bone
Neuro/Ophthalmology
Women’s Health
Oncology
Legacy SPKK Products
Anesthesiology
-
17 Tony Alvarez @ Pharma Delegates 012011
MSD’s pipeline has been expanding(As of December 27, 2010)
2010 Phase Ⅱ
Infectious Dis., V710
Cancer, MK-8669
Insomnia, MK-6096
Cancer, MK-0683NHL
2010 Phase III
Moved forward in 2010
Osteoporosis, MK-0822
Infectious Dis., MK-0991
Insomnia, MK-4305
HPV Vaccine, V-503
Cardiovascular, SCH-530348
Schizophrenia, SCH-900274
Atherosclerosis, MK-0859
Infectious Dis., MK-7009
Cancer, MK-0683Mesothelioma
-
18 Tony Alvarez @ Pharma Delegates 012011
Positioned for Growth: Successful Integration
Focus on Customer- Maximize product value
Deliver on Pipeline- Keep programs on time
Upgrade Capability- Develop and retain talents
Build Long-term Strategy- Set course for growth in
Research and Commercialization
Accelerate BreakthroughLaunch
-
19 Tony Alvarez @ Pharma Delegates 012011
Delivering on Our Pipeline:All Planned NDAs Achieved during Integration
*Add-on indication or new formulation
NDAs submitted in 2010
*Follistim®900IU
NDAs Under ReviewNDAs Under Review
Cervical cancer Vaccine
Rotavirus vaccine
*Januvia®AGI
*Follistim®900IU
Vorinostat
*Nasonex®unscented
Daptomycin
*Januvia®Insulin
2010Planned NDAs
2010Planned NDAs
Rotavirus vaccine
Daptomycin
*Januvia®AGI
Vorinostat
*Januvia®Insulin
All submissions completed
Product Approvals 2010
Product Approvals 2010
Bridion® (Jan)
*Temodal® (Jan)
Cosopt® (Apr)
-
20 Tony Alvarez @ Pharma Delegates 012011
Build Long-term Strategy:MSD’s R&D Strategy is Basis for Growth
► Focus on priority disease areas to meet unmet medical needs and maximize opportunities
– Bone, Respiratory, Immunology and Endocrine, Cardiovascular, Diabetes & Obesity, Infectious Diseases, Neuroscience, Women Health, Oncology, Vaccines
► Redefining R&D success by looking to customers and scientific leaders early and often in product lifecycle
► Leveraging technologies to facilitate drug discovery & development
► Ensure a more sustainable pipeline by translating basic research productivity into late-stage clinical success
► Focus on cycle time reductions
► Supplementing internal R&D capability withexternal collaborations
CycleTimeCycleTime
Probabilityof SuccessProbabilityof Success
ProductivityProductivity
CollaborationCollaboration
-
21 Tony Alvarez @ Pharma Delegates 012011
Agenda
New MSD: A compelling combination1 Introduction of New MSD
2 Japan’s New Growth Strategy 2010
3MSD’ Global Contributions to Japan’s Growth through Innovation
-
22 Tony Alvarez @ Pharma Delegates 012011
Japan’s Future in Innovation:The Cabinet’s New Growth Strategy (2010-20)► 4 growth areas and
3 infrastructure areas by 2020► In the 4 areas, 5 million new
employments and 123 trillion yen in demand will be created.
Science and Technology includes:1. Construct globally competitive
science-tech innovation systems2. Construct national strategy to
promote science-tech innovation3. Strengthen basic research and
accelerate innovation 4. Academia, government, and
industry collaboration is key
4 Growth Areas
Green Innovation
[Environment/E
nergy]
Life Innovation
[Health care/Nursing]
Asian Economy
Sightseeing/Region
3 Infrastructure AreasScience/
Technology/Telecommunication
Employment/Talent
Finance
1 2 3 4
5 6 7
-
23 Tony Alvarez @ Pharma Delegates 012011
Is the Growth Strategy Feasible?
► Aging Society Challenge ► Economic Stagnation
#27(2010)
#1(1990)
3) IMD* global competitiveness
8.9%(2008)
14.3%(1990)
2) Global share of GDP
#23(2008)
#3(2000)
1) GDP per one person
* International Institute for Management Development
Note: 1) , 2) IMF World Economic Outlook Database3) World Competitiveness YearbookSource: National Institute of Population and Social Security
Research
-
24 Tony Alvarez @ Pharma Delegates 012011
Does Economic Growth Strategy support Bio-Pharmaceutical Industries Comprehensively?
Increase Government investments & provide tax incentivesFoster science careers, attract global talent, align science education &
industry needsCross-Ministerial decision -making on budgets & strategies
Basic Research
A pre-requisite for reform: Improve clinical testing environment►Industry-Academia-Government partnerships crucial to success
Clinical Trials
A pre-requisite to reform: Drug approval decisions must be expeditedPMDA operational funds increased in 2010 Supplemental Budget
Regulatory Reviews
►Unapproved Drugs & Indications the primary issue►New Product Premium remains only a trial & not mentioned in Strategy►Pricing rules inconsistently incentivize innovative research
Pricing
Focus of Economic Growth StrategyOur Issues:
► Worldwide, the Bio-Pharmaceutical Industries thrive in a policy environment that comprehensively supports innovation.► Our Issues: Pricing to support innovation, globally-integrated
regulatory review processes, strong clinical trials environment,government support for basic research
-
25 Tony Alvarez @ Pharma Delegates 012011
Significant Growth in Singapore for Pharmaceutical Industries : Japan’s Competitors in Basic Research
► Importing global brains– Top global scientists / Novel prize level (more than 2,000)– ¼ of population come from other countries
► Major company’s core facilities newly built– Roche: Translational Research Center (2010)– Abbott: R&D Center (2010)– MSD: Translational Research Laboratory (2009)– Takeda: Clinical Research Center (2008)– Medtronic: Global Business Center and manufacturing site for
Pacemaker (2010)– Fujitsu: Healthcare Center (2010)– Waseda Univ.: Bio-Science Research Center (2009)
► Expected GDP growth in 2010: 13~15%– Pharma. Industry becomes a core to contribute its growth.
-
26 Tony Alvarez @ Pharma Delegates 012011
Japan’s Current trends:Impact to Pharma Industries - Challenges
►Increasing pressure on drug pricing and reimbursement
►Patent expiries and growing generic threats have increased
►Diversification of customer needs►Possibility of insurance system crisis►Persistence of slow-growth economy
-
27 Tony Alvarez @ Pharma Delegates 012011
Japan’s Current trends:Impact to Pharma Industries - Opportunities
►Aging population with growing healthcare needs►Rising incidence of chronic disease►High unmet medical needs, e.g. Alzheimer’s,
Oncology, etc.
►Increasing importance of preventive care- Increasing importance of promoting health of the working population
►Advancing science and technology enabling new drug discovery
-
28 Tony Alvarez @ Pharma Delegates 012011
Agenda
New MSD
New MSD: A compelling combination1 Introduction of the New MSD
2 Japan New Growth Strategy 2010
MSD’s Global Contributions toJapan’s Growth through Innovation3
-
29 Tony Alvarez @ Pharma Delegates 012011
29
Merck*/ Schering-Plough Integration:Commitment to Discovery and Development for Patients
►Schering-Plough and Merck R&D organizations share a common culture of scientific excellence
►Schering-Plough has an established presence in oncology and neuroscience, two areas Merck is building
►Schering-Plough’s expertise in novel biologics complements Merck’s BioVentures technology
►Schering-Plough’s therapeutic areas of focus complement those of Merck– Mechanistic diversity adds strength to our joint
pipeline
*Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
-
30 Tony Alvarez @ Pharma Delegates 012011
► Launching new commercial models around the world –including the U.S., EU, Japan and Canada – with common tenets:
– Focus on customer value and trust – Portfolio approach– Solutions to improve health outcomes– Multi-channel approaches and new technologies– Efficient management of resources through common
infrastructures, systems and processes
► Flexible models created by local market leaders who determine execution and channel selection based on local market dynamics and customer input
New, Differentiated Commercial Modelsto Grow Our Business
-
31 Tony Alvarez @ Pharma Delegates 012011
Investing in Future Growth► Merck BioVentures
► Regional Business Development
► Franchise Strategy
► Emerging Markets– Brazil, China, India,
Korea, Turkey, Russia and Poland
► Japan: Key Growth Market
Invest in Future Growth
Become Lean & Flexible
-
32 Tony Alvarez @ Pharma Delegates 012011
32
Best Positioned R&D Pipeline
File 20111Filed 2009 File 20101 File 20121
• AIT Grass3 (US)
• BRIDION® (US)
• Ezetimibe + Atorvastatin
• SAFLUTAN® (US)
• Sitagliptin + Pioglitazone
• Telcagepant
• Vorapaxar
• BRINAVESS (EU)
• DULERA2
• NOMAC/E2 (EU)
• SYCREST (EU)
• Boceprevir
• JANUMET® XR (US)
• NOMAC/E2 (US)
• Ridaforolimus
• Sitagliptin + Simvastatin
• Acadesine
• AIT Ragweed (US)
• ELONVA (US)
• MK-0524A (US)
• MK-0524B
• MK-4305
• Odanacatib
• V503
1Anticipated filing date2Trade name DULERA is under regulatory review in the US3Anticipated filing 2010/2011
-
33 Tony Alvarez @ Pharma Delegates 012011
33
Today’s MSD R&D Strategy:Continued Investment in Innovation
Extract greatest pipeline value fromInnovative internal and external R&D
►Ensure a strong internal research capability►Leverage the capability through collaborations►Openly collaborate with the best partners►Continually evaluate potential transactions
– From platform technologies to late-stage product opportunities
– In a coordinated approach across the company►Celebrate the global and distributed nature of innovation!
-
34 Tony Alvarez @ Pharma Delegates 012011
34
Collaboration Creates Value
MSD
• Novel technology application
• Clinical Development
• Commercialization expertise
• Subject Matterexpertise
Partners
• Discovery• Innovation• Formulation• Subject Matter
expertise
Combining our StrengthsSharing our Successes
34
-
35 Tony Alvarez @ Pharma Delegates 012011
35
• MSD publishes our Areas ofInterest twice each year.
• For each therapeutic area, welist the Mechanism of Actionsthat we are interested in andthose that we are not.
• Late-stage clinical compounds(phase 2b or beyond) are ofinterest in any therapeutic area.
• Visit us at:www.merck.com/licensingto learn more!
We have defined our Areas of Interest
35
Merck & Co., Inc.,Whitehouse Station, N.J., U.S.A.
-
36 Tony Alvarez @ Pharma Delegates 012011
Build Long-term Strategy:Partnerships as the Foundation
Basic Basic Research Research
Drug Drug Discovery Discovery
Drug Drug Development Development
Clinical Clinical TrialTrial ApprovalApproval
Pharmaceutical IndustryPharmaceutical Industry
VC/BiotechVC/Biotech
AcademiaAcademiaAcademiaAcademia
Source: Alzheimer’s & Dementia, 2008 (modified)
AcademiaAcademia
• Academia, Pharma and Biotech more closely collaborate, expanding Academia’s role• Academia will be more involved in drug development stage (e.g. development and understanding of appropriate animal models…)
-
37 Tony Alvarez @ Pharma Delegates 012011
Academia: Powerhouse of Innovation
► Novel drug target for unmet medical needs► New methodologies for target validation in human biological function► Elucidate pathogenetical and pathophysiological mechanism of
intractable diseases► Innovative technology platform for drug development► Biomarkers for disease and pharmacology
Breakthrough knowledgeNew concepts of diseaseEpoch-making technology
PowerhousePowerhouseofof
InnovationInnovation
What pharmaceutical industries need from academia
-
38 Tony Alvarez @ Pharma Delegates 012011
Collaborative and Innovative R&D Partnering with Academia IncreasesTraditional Approach► Narrow alliance on specific
technology/knowledge► Restricted contracts► Separate labs► Limited information exchange
Collaborative Approach► Broad alliance on certain disease area
or research field► Comprehensive contracts► Fusion labs/frequently visit each other► Share all information
► Harvard Medical School – Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., 2007
– A broader R&D alliance to conduct research into oncology and central nervous system disorder
► Columbia University - AstraZeneca, 2008– A broader pact to develop new drugs for diabetes and obesity, and to pursue
basic research for neurology
► Universities in UK – Shionogi, 2009– International academia-industry collaboration initiatives with the United
Kingdom to research and develop new seeds for innovative medicine
Collaborative Approach
-
39 Tony Alvarez @ Pharma Delegates 012011
We have a long history of successful collaborations with Japanese partners
Kyorin: NOROXIN®First quinolone antibiotic
Yamanouchi: PEPCID®H2 antagonist for ulcers
Kitasato Institute: ivermectinAntiparasitic for animals/humans
Osaka University/Biken: VARIVAX® /ZOSTAVAX®Varicella virus vaccines
Japan Tobacco: JTT-305Osteoporosis
Santen: SAFLUTAN®Prostaglandin analogue for Glaucoma
-
40 Tony Alvarez @ Pharma Delegates 012011
Seeking Potential Partners in Japan During 2010- Much More Coming in 2011
MSD Satellite Luncheon Seminar at Bio International 2010 in Chicago
“New MSD Worldwide Licensing Strategy”- How to Work Together with Asia Pacific Partners -
MSD Technology Days and Partnering Meetings at Bio-Expo Japan 2010 in Tokyo
Wants and Needs of MSD in Basic Research and Platform Technology - A Showcase for Partnerships in Biomarkers, Drug Delivery-Formulation and Data Management-Mining Technologies
Luncheon Seminar and Partnering Meetings at Bio Japan 2010 in Yokohama
-
41 Tony Alvarez @ Pharma Delegates 012011
Toward the Best Healthcare Company in Japan
Meet unmet medical needs
Deliver high customer value
Achieve long-term growth
Most trusted partner in science and innovation
-
42 Tony Alvarez @ Pharma Delegates 012011
Thank you !