simcere company presentation 2011.9
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Simcere Pharmaceutical Group Emerging Leader in Developing, Manufacturing and
Marketing of pharmaceutical products in China
September 2011
Disclaimer
The information contained in this presentation does not constitute or form part of any offer for sale or subscription of or solicitation or invitation of any offer
to buy or subscribe for any securities nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment
whatsoever. Any public offering of the securities to be made in the United States will be made solely by means of the prospectus in the registration
statement. The prospectus contains detailed information about the Company and its management as well as the financial statements of the Company.
Any decision to purchase securities in the offering for sale in the United States or anywhere else should be made solely on the basis of the information
contained in the prospectus. This presentation does not contain all relevant information relating to the Company or its securities, particularly with respect
to the risks and special considerations involved with an investment in the securities of the Company, and is qualified in its entirety by reference to the
detailed information appearing in the prospectus.
This presentation contains forward-looking statements, including statements about the Company’s business outlook, our strategy and market opportunity,
and statements about the Company’s historical results that may suggest trends for its business. These statements are individually and collectively
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
These forward-looking statements are made only as of the date of this presentation and the Company undertakes no obligation to update or revise.
These statements are based on estimates and information available to the Company at the time of this presentation and are not guarantees of future
performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Therefore, prospective investors are cautioned
that actual results may differ materially from those set forth in any forward-looking statements herein.
The information contained in these slides has not been independently verified. No representation or warranty, express or implied, is made as to, and no
reliance should be placed on, the fairness, accuracy, completeness or correctness of any information or opinion contained herein. The information
contained in these slides should be considered in the context of the circumstances prevailing at the time and has not been, and will not be, updated to
reflect material developments which may occur after the date of the presentation. None of the Company, any underwriter of securities of the Company, or
any of their respective directors, officers, employees, agents or advisers shall be in any way responsible for the contents hereof, or shall be liable for any
loss arising from use of the information contained in this presentation or otherwise arising in connection therewith.
Before you invest, you should read the prospectus in the registration statement the Company filed with SEC and other documents the Company has filed
with the SEC for more complete information about the Company and this offering. You may get these documents for free by visiting EDGAR on the SEC
Web site at www.sec.gov. Alternatively, you may request the prospectus by sending us a request via our website at www.simcere.com.
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Company Snapshot
Publicly listed on NYSE, with highest standard of corporate compliance and transparency
~3000 sales reps and 1,500 distributors, covering over 3,000 hospitals and 70,000 retail
pharmacies
Leading R&D capabilities in China ranging from early stage discovery to clinical operations
8 GMP facilities supporting small molecule, biologics, and vaccine manufacturing 3
A Leader in China’s Pharmaceutical
Industry
304
466 564
737
951
1369
1741
1850
2141
0
500
1,000
1,500
2,000
2,500
2002 2003 2004 2005 2006 2007 2008 2009 2010
Ranking:
#21 in Net Profit in
China
healthcare
industry*
#7 among the Top
20 most
competitive
public listed
healthcare
companies in
China
* 2009 Chinese Medical Statistical Yearbook by Ministry of Industry and Information Technology of PRC
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Revenue (M, RMB)
Key Strategy
Focus on five therapeutic areas in the mid to high-end markets
Oncology, Neuroscience, Cardiovascular, Inflammation, and Infectious
Disease
Leveraged on deep channel penetration and branding advantage to
expand generic market
Strengthening in-house R&D capabilities and cross boarder
collaboration to develop products quickly and effectively
Executing Our Product-Oriented M&A Strategy
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Differentiated Products with Market Leadership in
Oncology and CNS
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Therapeutic Area Brand Name Product
Oncology
Endu Proprietary recombinant human endostatin injection, NSCLC
Jiebaishu Nedaplatin injection
Sinofuan 5FU sustained release implant
Jiebaili Pemetrexed
Lowvo Palonosetron
Neuroscience Bicun/Yidasheng Edaravone injection, ischemic stroke
Cardiovascular
Xinta Levamlodipine besylate tablets, hypertension
Shufutan Rotuvastain generics, hyperlipidemia
Infectious Disease Anxin Biapenem injection, bacterial infection
I
nflammation Yingtaiqing Diclofenac sodium delayed release capsules , arthritis pain
Strong Commercial Muscle and Deep Channel
Penetration
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Over 3,000 hospitals Over 70,000 retail
pharmacies
Large field force with broad geographical reach
Proven Ability To Quickly
- Select and Position Product - Generate Strong Sales - Build Up Brand and Loyalty
• Collaborating with distributors who have direct selling to the end customers
• Continuing to build up our well trained professional sales team
• Cooperating with nation wide top drug store chains
• Seeking opportunities to leverage on the healthcare reform
Diversified R&D Strategy to Deliver
Sustainable Pipeline
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Approaches
• Branded generics
• First-to-market generics
• Biosimilar
• Novel: best-in-class
Therapeutic Areas
• Oncology
• Neuroscience
• Cardiovascular
• Infectious disease
• Inflammation
Treatment Modalities
• Small molecules
• Biologics
• Peptides
• Vaccines
With Increasing Focus on Novel Products
Category Contribution to Revenue
2005 2006 2007 2008
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Endu: Proprietary Molecular Targeted
Therapy for NSCLC
rh-Endostatin with nine
additional AAs at the N-
terminus (Endostar)
Stable at low pH (2.5) and at
high temperature (100 ℃)
Solubility: >15 mg/ml
Shelf life: 18 months at 4 ℃
Manufactured in E. coli
Large-scale inclusion body
refolding
0.5 mg/ml, with >50%
recovery Endostatin Endu(Endostar)
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Pipeline Overview
Inflammation Iguratimod tablets
Oncology Oxaliplatin
Oncology Endu combined with NP Therapy
Cardiovascular rh-RGD-Hirudin for injection
Oncology Bendamustine for injection
Cardiovascular Oral fixed dose combination of
amlodipine & irbesartan
Oncology SIM-0930 (protein tyrosine kinase
inhibitor)
Oncology SIM6802 (protein tyrosine kinase
inhibitor)
Oncology SIM010603 (protein tyrosine
kinase inhibitor)
Oncology SIMBD0801 (MAb)
Cerebrovascular SIM071201
Oncology SIM0710 (PEG-Endostar injection)
Onclogy SIM-817378
Key Product
Candidate
Therapeutic
Areas
Status
Pre-
clinical
Phase
I
Phase
II
Phase
III
New Drug
Application
Lead
Optimization
Lead
Discovery IND
IND approved
Approved
A staff of ~300, located in Nanjing, Shanghai, Beijing and Yantai
PhD: ~20%; MS: ~60%; 25 staff members with Western training/working experience
Ongoing aggressive recruitment of industrial veterans from US in all R&D areas
Nanjing R&D Center: 200,000 sf
7% of total revenues as R&D budget
Institute of Discovery Chemistry
Nanjing Prof. Xiaojin Yin, SVP
Dr. Peng Wang, CSO
Institute of Discovery Biology
Nanjing
Institute of Chem., Pharm.
& Anal. Development
Nanjing
Institute of Biologics Research
Nanjing
Institute of Vaccine
Research
Nanjing
Shanghai R&D Center
Shanghai
Recombinant Proteins R&D
Center
Yantai
Beijing
Dept. of Market Res. and Business
Development
Nanjing
Institute of Clinical
Research
Nanjing
Office of Intellectual Properties
Nanjing
Dept. of Project
Management
Nanjing
Dept. of Regulatory
Affairs
Nanjing
Beijing
Dept. of Operation &
HR
Nanjing
Simcere R&D Organization
Strong Track Record
Clinical development:
Over 30 successfully completed clinical trials
Endu Ph IV trial completed in Dec. 2009, with >3,000 patients recruited, the largest clinical
study in China history
Regulatory affairs:
Approximately 100 NDAs/ANDAs obtained
Five (5) INDs filed in 2010 alone
A FIH trial in Australia completed
Endu has been re-registered for marketing authorization in 2010: the first in China
New head of Regulatory Affairs, Mr. Bo Xu (a former SFDA reviewer), has been on board
since 2010
~120 patents and patent applications
Over 100 scientific publications
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M&A Licensing and
Collaboration
Internal
Programs
Externalization Critical to Overall
R&D Strategy
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Selected Key Partnerships
Innovative Strategic Partnership
Joint Venture partnership with Merck (2011):
A transformational deal that cements Simcere’s
leadership in branded generics market in China
A strategic partnership with development,
registration, manufacturing and sales capabilities
Initial focus on cardiovascular and metabolic
diseases
R&D strategic partnership with BMS (2010):
Co-development partnership
A small molecule oncology compound in preclinical
development
Simcere responsible for development and
commercialization in China
BMS has option to resume global development (ex-
China) after Simcere achieves PoC in man
Traditional In-Licensing
OSI Pharmaceutical (2009):
A small molecule protein kinase inhibitor in Phase I
development
Simcere responsible for development and commercialization
in China
OSI responsible for ex-China global development
Epitomics (2009):
A humanized rabbit monoclonal antibody in preclinical
development
Simcere responsible for development and commercialization
in China
Simcere and Epitomics to share cost of development
outside of China
GSK (2006):
Simcere licensed the rights to develop an authorized generic
version of Relenza in China
Product approved in China in 2010
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Key Areas of Partnering Interests
Oncology
Molecular targeted therapies of both small molecules and biologics
based on validated or novel mechanism of action
Cytotoxics differentiated on efficacy and/or tolerability with proof-of-
concept in man
Early stage opportunities and novel technology platforms that lead to
step change in cancer therapy
Neuroscience
Cerebrovascular disease treatment and neuroprotectant
Alzheimer’s Disease – disease-modifying therapies with proof-of-
concept in man
Cardiovascular and Metabolic Disease
Atherosclerosis, thrombosis, anti-coagulation, anti-platelet, atrial
fibrillation agents and diabetes
Infectious Diseases
Antibacterias that address bacterial resistance and serious infections
Antifungals
Antivirals – HBV and HCV only
Inflammation
Rheumatoid Arthritis – disease modifying agents with potential to
differentiate based on efficacy and/or cost of treatment
Flexible deal
structures
Aim to create win-
win partnership
Structure deals to
fit partner’s
strategy
Committed to
fostering growth
and sharing
success
Efficient process
Identify and
evaluate
opportunity
Conduct due
diligence and
negotiate
agreement
Implement and
manage project,
moving toward
success
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Value Proposition to Partners
Leverage Simcere’s internal R&D capability to develop partner’s asset in
China under the FDA and SFDA requirements
Accelerate clinical trials indications through faster patient enrollment
Generate critical data package to support global development
Leverage Simcere’s powerful commercial platform to achieve rapid and
broad market access
Utilize Simcere’s experience, resources, leadership and homeland
advantage to penetrate the market
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Simcere’s Commitment
Clear corporate mandate of externalization
Bring products to address significant unmet medical needs in China
through sourcing global innovations
Commitment to fostering partnership and sharing success
Flexible deal structures
Highest standard of corporate compliance and transparency
Experienced management team with proven track record
World-class R&D leadership team with U.S. industry veterans
Clinical Advisory Board with leading thought leaders in the U.S.
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