Simcere Company Presentation 2011.9


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Simcere Company Presentation 2011.9

  1. 1. Simcere Pharmaceutical GroupEmerging Leader in Developing, Manufacturing andMarketing of pharmaceutical products in ChinaSeptember 2011 1
  2. 2. 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 Alternatively, you may request the prospectus by sending us a request via our website at 2
  3. 3. 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
  4. 4. A Leader in China’s PharmaceuticalIndustryRevenue (M, RMB) 2,500 Ranking: 2141 2,000 1850 #21 in Net Profit in 1741 China healthcare 1,500 industry* 1369 #7 among the Top 1,000 951 20 most competitive 737 public listed 564 466 healthcare 500 304 companies in China 0 2002 2003 2004 2005 2006 2007 2008 2009 2010* 2009 Chinese Medical Statistical Yearbook by Ministry of Industry and Information Technology of PRC 4
  5. 5. 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 5
  6. 6. Differentiated Products with Market Leadership inOncology and CNS Therapeutic Area Brand Name Product Endu Proprietary recombinant human endostatin injection, NSCLC Jiebaishu Nedaplatin injection Oncology Sinofuan 5FU sustained release implant Jiebaili Pemetrexed Lowvo Palonosetron Neuroscience Bicun/Yidasheng Edaravone injection, ischemic stroke Xinta Levamlodipine besylate tablets, hypertension Cardiovascular Shufutan Rotuvastain generics, hyperlipidemiaInfectious Disease Anxin Biapenem injection, bacterial infection I Yingtaiqing Diclofenac sodium delayed release capsules , arthritis pain nflammation 6
  7. 7. Strong Commercial Muscle and Deep ChannelPenetration 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 Large field force with broad geographical reach Over 3,000 hospitals Over 70,000 retail pharmacies 7
  8. 8. Diversified R&D Strategy to DeliverSustainable Pipeline Approaches Therapeutic Treatment Areas Modalities • Branded generics • First-to-market • Oncology • Small molecules generics • Neuroscience • Biologics • Biosimilar • Cardiovascular • Peptides • Novel: best-in- • Infectious disease class • Vaccines • Inflammation 8
  9. 9. With Increasing Focus on Novel Products Category Contribution to Revenue 2005 2006 2007 2008 9
  10. 10. Endu: Proprietary Molecular TargetedTherapy 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% Endostatin Endu(Endostar) recovery 10
  11. 11. Pipeline OverviewTherapeutic Status Key Product Areas Candidate Lead Lead Pre- IND Phase Phase Phase New Drug Discovery Optimization clinical I II III ApplicationInflammation Iguratimod tablets ApprovedOncology OxaliplatinOncology Endu combined with NP TherapyCardiovascular rh-RGD-Hirudin for injectionOncology Bendamustine for injectionCardiovascular Oral fixed dose combination of amlodipine & irbesartan SIM-0930 (protein tyrosine kinaseOncology inhibitor)Oncology SIM6802 (protein tyrosine kinase IND approved inhibitor) SIM010603 (protein tyrosineOncology kinase inhibitor)Oncology SIMBD0801 (MAb)Cerebrovascular SIM071201Oncology SIM0710 (PEG-Endostar injection)Onclogy SIM-817378
  12. 12. Simcere R&D Organization Institute of Recombinant Institute of Institute of Institute of Institute of Proteins R&D Discovery Chem., Pharm. Shanghai Discovery Biologics Vaccine Center Chemistry & Anal. R&D Center Biology Research Research Development Shanghai YantaiProf. Xiaojin Yin, Nanjing Nanjing Nanjing Nanjing Nanjing Beijing SVPDr. Peng Wang, CSO Dept. of Market Dept. of Institute of Office of Dept. of Regulatory Dept. of Res. and Clinical Intellectual Project Affairs Operation & Business Research Properties Management HR Development Nanjing Nanjing Nanjing Nanjing Nanjing Nanjing Beijing 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
  13. 13. 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 13
  14. 14. Externalization Critical to OverallR&D Strategy Internal Programs Licensing and Collaboration M&A 14
  15. 15. Selected Key Partnerships Innovative Strategic Partnership Traditional In-Licensing  Joint Venture partnership with Merck (2011):  OSI Pharmaceutical (2009):  A transformational deal that cements Simcere’s  A small molecule protein kinase inhibitor in Phase I leadership in branded generics market in China development  A strategic partnership with development,  Simcere responsible for development and commercialization registration, manufacturing and sales capabilities in China  Initial focus on cardiovascular and metabolic  OSI responsible for ex-China global development diseases  R&D strategic partnership with BMS (2010):  Epitomics (2009):  Co-development partnership  A humanized rabbit monoclonal antibody in preclinical  A small molecule oncology compound in preclinical development development  Simcere responsible for development and commercialization  Simcere responsible for development and in China commercialization in China  Simcere and Epitomics to share cost of development  BMS has option to resume global development (ex- outside of China China) after Simcere achieves PoC in man  GSK (2006):  Simcere licensed the rights to develop an authorized generic version of Relenza in China  Product approved in China in 2010 15
  16. 16. Key Areas of Partnering Interests  Oncology Flexible deal  Molecular targeted therapies of both small molecules and biologics structures based on validated or novel mechanism of action  Aim to create win-  Cytotoxics differentiated on efficacy and/or tolerability with proof-of- win partnership concept in man  Structure deals to  Early stage opportunities and novel technology platforms that lead to fit partner’s step change in cancer therapy strategy  Neuroscience  Committed to fostering growth  Cerebrovascular disease treatment and neuroprotectant and sharing  Alzheimer’s Disease – disease-modifying therapies with proof-of- success concept in man Efficient process  Cardiovascular and Metabolic Disease  Identify and  Atherosclerosis, thrombosis, anti-coagulation, anti-platelet, atrial evaluate fibrillation agents and diabetes opportunity  Infectious Diseases  Conduct due  Antibacterias that address bacterial resistance and serious infections diligence and  Antifungals negotiate agreement  Antivirals – HBV and HCV only  Implement and  Inflammation manage project,  Rheumatoid Arthritis – disease modifying agents with potential to moving toward differentiate based on efficacy and/or cost of treatment success 16
  17. 17. 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 17
  18. 18. 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. 18