Company Presentation

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1 Company Presentation

2 DISCLAIMER This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and asset situation of amp biosimilars AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and thus are subject to risks and elements of uncertainty that could result in deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. amp biosimilars AG does not intend to update the forward-looking statements and assumes no obligation to do so. All figures reported relate to the Continuing Operations of amp biosimilars AG. All comparative figures relate to the corresponding last year s period, unless stated otherwise. 2

3 Contents Executive Summary Biosimilars and the Market Opportunity Company and Team Track Record and USPs The Road Ahead Financials 3

4 amp biosimilars: Biotechnology 2.0 amp biosimilars AG is one of Europe s leading pure play biosimilar companies. amp biosimilars AG has created a unique platform which enables it to develp biosimilars faster, cheaper and more efficiently than anyone else before. Its management and partners represent more than 125 years of combined excellence and expertise in biosimilars 4

5 Executive summary biosimilars the rapidly advancing multi-billion opportunity in pharma with growth from 3bn $ to around 110bn $ until 2024 amp a leading German biosimilar group with acess to global markets top management with proven track-record in biosimilars and biotech low cost development facilitesto be set up in China further potential for more than 20 biosimilars to be developed for global markets full market access with global partners future Chinese joint ventures to finance production facilities and R&D attractive risk/reward profile for investors Why amp biosimilars? 5

6 Contents Executive Summary Biosimilars and the Market Opportunity Company and Team Track Record and USPs The Road Ahead Financials 6

7 What are Biosimilars? A biosimilar medicinal product is a biological medicine which is similar to another biological medicine that has already been authorised for use, the reference medicinal product or originator product. By completion of phase I risk is reduced by 80% and no Phase II necessary = less development risk A biosimilar product and its reference biopharmaceutical product are expected to have the same safety and efficacy profile. With Phase III biosimilar products are authorised either for all, or selected indications of the reference medicinal product on a case by case basis = access to huge market volume The development and the manufacturing process of biosimilar medicinal products are more complex and expensive than generics of chemical (small molecule) products but the R&D cost still account for only 10% of of the original biological product! = less cost =A huge new market at marginal costs with less risk 7

8 The Market Opportunity Biosimilars are the fastest growing sector in life sciences Global market of biosimilars approved in highly regulated markets 1 USD Billion Biosimilar market could reach $15 billion by 2020 up from $1.3 billion in 2013 in highly regulated markets alone $35 billion by 2020 in global markets forecasted EU is leading the biosimilar market globally with Germany providing the most favourable environment for biosimilar drugs Chinese biosimilarmarket could already grow to 20% of the global market until Highly regulated markets include North America, Europe, Japan and Australia Source: IMS; company annual reports; Datamonitor; Pharmaceutical Key Trends 2011; Sandoz analysis Assumptions: Between 2017 to 2020 major ramp up of biosimilar monoclonal antibodies launched in EU/US expected 8

9 What makes biosimilars so special? biosimilarsoffer access to existing multi-billion dollar markets with a reduced development risk due to the usage of an already known substance biosimilars do not need phase II clinical trials biosimilarsare expected to relieve strained health care budgets highly similar analytical and PK/PD data assumes lower risk of clinical differences phase III using comparator drug allows extrapolation to all indications acceptable biosimilarsallow the use of an alternative drug delivery device competitive pricing allows access to higher potential patient numbers Biosimilars gain up to 50% of the originators market share to 10% development costs 9

10 Growth Potential and Market Needs in 2014, 8 of the top 10 best-selling pharmaceuticals are biologics with a combined turnover of $55,2 billion Approximately $100 billion of originator biologic are expected to lose patent exclusivity by 2020 the top six biologics already consume 43% of the drug budget for US Medicare Part B first wave of high-quality biosimilars are gaining acceptance rising demand and high cost of biologics will continue to strain shrinking health care budgets a pathway for biosimilars is expected to save the US about $25 billion over 10 years from 2009 to 2018 biosimilars are expected to save between 11,8 to 33,4 billion between in 8 EU countries 10

11 Contents Executive Summary Biosimilars and the Market Opportunity Company and Team Track Record and USPs The Road Ahead Financials 11

12 amp biosimilars: Biotechnology 2.0 amp biosimilars AG has created a unique platform which enables it to develop biosimilars faster, cheaper and more efficiently than anyone else before 400-L bioreactor Batch Fed batch Perfusion Automated Fill and Finish Ampoules Vials Manual Fill & Finish Infusion bags Vials Process chromatography 12

13 The Company With a history of developing pharmaceuticals for some of the worlds biggest pharmaceutical corporations, a long experience in biosimilar development and approval, ampb is ideally positioned for a leading role in the strongest growing market for pharmaceutical products: biosimilars Strong partnerships and potential joint ventures for commercialisation in highly attractive pharma markets around the globe ampb combines all necessary core capabilities to form one of the leading biosimilar companies: Track record in technical and device development State-of-the-art analytics capabilities Excellence in clinical study design & execution Worldwide regulatory and policy experience Reliable global manufacturing network Partners with excellent commercialization skills 13

14 The Team Senior Management Team with Long Track Record and Deep Industry Experience Dr. Marc Hentz Chief Executive Officer & Co-Founder Global Group Strategy Strategic Partner Relations Joint Venture coordination Financials Investor Relations Gerry McGettigan Chief Operating Officer Scale-up Manufacturing CMO management Clinical Regulatory Dr. Knut Adermann Chief Technology Officer & Co-Founder R&D Project coordination Analytics Pre-clinical development Intellectual Property 14

15 Contents Executive Summary Biosimilars and the Market Opportunity Company and Team Track Record and USPs The Road Ahead Financials 15

16 The team integrates all skills essential in order to successfully compete in biosimilars. Technical Development Skills Thorough understanding of process development Expertise in microbial fermentation and mammalian cell culture Expertise in bioanalytics, including design and testing Quality-by-design (QbD) experience and processes Clinical Trial Expertise Clinical trial design expertise in relevant therapeutics area Access to trial centers in various locations to conduct studies Regulatory Expertise Strong regulatory team to interface with agencies in development of acceptable, streamlined regulatory packages (especially in absence of specific guidance) Expertise in filing and approval process Manufacturing Expertise Track record in cgmp manufacturing Access to approved cgmp facilities with appropriate technology platforms and competitive COGS Sufficient scale to meet demand Commercial Expertise Experience in setting up and running biotech companies Board level experience Successful project management in lean development organizations Commercial strategy 16

17 Superior Expertise and Proven Track Record in biosimilars Selected Projects Products Biosimilar development and tech transfer project to Thailand (growth factor) Biosimilar strategy for Saudi Arabian Ministry of Health Growth factors Monoclonal antibodies Hormones Major due diligence for large US distributor to enter market Buy side due diligence for FSH Several sell side due diligences for US companies Clinical, Nonclinical & Regulatory support for 4 mabs in EU and USA Several meetings and advice procedures with EMA and FDA Indications Oncology Rheumatoid Arthritis Haematology Neutropenia Renal disease IVF Detailed development strategic analyses for mabs Supporting major manufacturing change for large biotech Various other projects inc. strategic analyses for mabs 17

18 But what makes amp biosimilars so special? Competitive advantage: Unique platform to develop biosimilars faster, cheaper and more efficiently Experienced team of successful entrepreneurs Track record in building lean & efficient development organizations Proven biosimilar competence: developmental, regulatory & manufacturing Exclusive development and manufacturing facilities 100 years of experience in biologicals Proven skill set for complex products, e. g. Antibodies 18

19 Contents Executive Summary Biosimilars and the Market Opportunity Company and Team Track Record and USPs The Road Ahead Financials 19

20 Numerous biosimilars to come out of amp platform ampb list of selected potential future candidates Product Originator Indication Sales (US$M) (Year) Patent Off (early/late) Simponi (golimumab) Erbitux (cetuximab) Orencia (abatacept) Prolia (denosumab) Stelara (ustekinumab) Yervoy (ipilimumab) Cimzia (certolizumab) Merck / J&J RA, UC, AS, PsA 500 (2013) 2015 / 2027 BMS / Merck Cancer (CRC, H&N, NSCLC) 2016 (2013) 2015 / 2018 BMS RA 1170 (2012) 2018 / 2029 Amgen Osteoporosis 1200 (2012) 2016 J&J Psoriasis, PsA 1025 (2012) 2005?? BMS Melanoma 706 (2012) 2019 / 2026 UCB RA, Crohn s, AS, PsA 760 (2013) 2019 /

21 Contents Executive Summary Biosimilars and the Market Opportunity Company and Team Track Record and USPs The Road Ahead Stock information 21

22 Shareholder structure and Stock details amp biosimilars AG DE-Symbol: 1YA ISIN: DE000A0SMU87 DE-Security Code: A0SMU8 Par value: none / bearer shares Total shares: 2,050,000 Reg. Capital: EUR 2,050, Stock Exchange: Munich, Germany Shareholding Structure 22

23 Executive Summary biosimilars the new multi-billion opportunity in pharma with growth from 3,5bn to 35bn $ until 2020 ampb a leading German biosimilar group with access to global markets high quality management with proven track-record in pharma and biosimilars low-cost production facility to be set up in China potential for numerous biosimilars to be development for global markets full market access with top tier partners future Chinese joint ventures for production facilities and R&D attractive risk/reward profile for investors in addition to superior growth perspective 23

24 Contact Dr.Marc W. Hentz Chief Executive Officer amp biosimilars AG Am Kaiserkai Hamburg Germany Tel: Tel: