DC276 Genpharm July2014
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GENPHARM OVERVIEW July 2014 Business Overview Creating specialty pharmaceuticals leadership in MENA … Overview Genpharm is a specialty pharmaceutical marketing and consulting company focused on niche therapeutics and diagnostics for rare disease Specialty Therapeutic Focus Women’s Health Immunology Infectious Disease Neurology Rare Disease Iran Morocco Algeria Libya Egypt Saudi Arabia Oman Yemen It provides fast and sustainable market access into the MENA (Middle East & North Africa) region to its strategic partners including regulatory and medical Geographical Presence Tunisia Iraq Jordan Morocco Algeria Libya It provides Business Development and market analysis for companies looking to evaluate the potential of their portfolio in MENA. Syria Lebanon Egypt Saudi Arabia Iran Kuwait Bahrain Qatar UAE (Dubai, Headquarter) Yemen MENA It acts as the representative agent for rare disease, biotech and specialty pharma companies looking to enter or to expand in the MENA Confidential 2 Company Overview Mission, Vision & Values Our Vision Mission Statement “We strive to be the partner of choice for multinational healthcare and pharmaceutical companies expanding into the Middle East and North Africa region. To provide healthcare organizations with innovative therapeutic solutions in niche and rare genetic disease areas, market access strategies and sustainable commercial solutions, while improving patient care and quality of life in the Middle East and North Africa. Iran We aim to consistently differentiate ourselves by serving all of our stakeholders through evidence based medicine.” Core Values Patient Care Innovation Accountability Integrity Teamwork We are dedicated to patient care and quality of life We offer unique and sustainable solutions We are committed, reliable and results focused We act honestly, with inclusivity and respect We are positive, professional and transparent Confidential 3 Targeted and Focused Positioning for Genpharm Genpharm is purposely positioned in the original brands market… Segment Value by Country Business Model Characteristics for different product types 100% 80% 1% 6% Branded Generics Unprotected Originals Protected widely RX Niche Specialty 8% 3% 1% 10% 8% 2% 8% 10% 55% 56% 52% 48% 32% 34% 38% 40% Egypt Jordan Morocco Tunisia 2% 34% 49% 60% Unbranded Generics 1% 40% 59% Commodity 42% 20% Differentiated 0% UAE High Volume & Low Margin Tight Control of Cost Focus on Supply Chain Purchasing professionals are the key stakeholders Promote price and service Seek scale to gain cost efficiencies and market power Lower Volume & High Margin Emphasis on Quality Focus across a complex set of stakeholders Promote efficacy, safety, tolerability Seek differentiation to drive demand Original Brands KSA Branded Generics Others Unbranded Generics Segment Volume by Country 100% 2% 1% 2% 12% 12% 16% 3% 2% 18% 17% 80% 60% 57% 61% 60% 61% 30% 27% 22% 18% UAE KSA Egypt Jordan 29% 54% 52% 40% 20% 2% 27% 18% 0% Original Brands Source: IMS MIDAS June 2012, Licensing Data, Rx bound Note: RX = Protected Formula/Product Confidential Branded Generics Others Morocco Tunisia Unbranded Generics 4 Supportive MENA Pharmaceutical Market Genpharm operates across the entire MENA region and in 8 countries out of the top 10 MEA countries MEA Pharmaceuticals Sales (€ bn) (Top 10 by 2017 sales) 6.0 9% 5.1 14% 5.0 4.8 4.0 8% 3.4 3.4 7% 3.1 3.0 5% 31% 2.5 2.3 2.4 2.3 2.2 13% 1.9 2.0 1.9 10% 1.5 1.0 1.0 1.0 -5% 5% 0.9 1.1 1.2 1.0 0.6 0.0 KSA Egypt South Africa Algeria Iran Libya Nigeria UAE 2012 (Genpharm MEA Countries) 2012 (Non-Genpharm MEA Countries) 2017 (Genpharm MEA Countries) 2017 (Non-Genpharm MEA Countries) Morocco Syria Source: IMS Health Market Prognosis May 2013. Values ex-mfn. at constant exchange rate. Revised Forecast due Sept 30 2013. Confidential 5 Company Overview Overview of current Products & Services Global Pharmaceutical Manufacturers Genpharm Services Consultancy Specialty Pharma Identify business potential Registration Recommend appropriate business & operations models Marketing, Promotion & sales force effectiveness Recommend strategy & organization Importation & distribution & Tender participation Formulate adapted market access strategies Medical & PV services Fast track market penetration through NPS Current Partners and Products Aubagio Juxtapid Stalor al NIOX Baclofe n ChondroCele ct NIPT PrenaTest Gene Therapy Bemfola Sustainable market access solutions that provide long-term value Confidential 6 Company Milestones In 24 months Gene Therapy Market Assessment Multiple-year agreement with Aegerion Pharmaceutical Signs commercializaton agreement with Genzyme for Aubagio in MS Signs commercialization and distribution agreement for PrenaTest Sponsors orphan drug meeting Geneva Jun, 2014 Apr, 2014 Nov, 2013 Jun, 2013 Apr, 2013 Apr, 2014 Dec, 2012 Jan, 2014 Oct, 2013 Signs promotional agreement for Stallergenes’ AIT treatments in the UAE Holds ASPIRE event for MENA Neurologists Apr, 2013 Oct, 2012 Feb, 2013 Nov, 2012 Signs agreement for commercialization of Bemfola Signs commercialization deal for Baclofen Sponsors Orphan Drug Congress, Washington Sponsors orphan drug meeting in Washington DC, US Stallergenes SA and Genpharm Services extend collaboration to Egypt Signs agreement for commercialization of ChondroCelect April, 2012 Genpharm starts operations Confidential 7 Portfolio overview Bemfola® is the first Swiss biosimilar recombinant FSH, approved by the EMA for the treatment of couples suffering from Infertility Baclofen Baclofen® Sintetica Intrathecal is indicated severe chronic spasticity originating from Multiple Scelerosis, Trauma or other spinal cord disorders unresponsive to other orally administered antispastic agents and/or for patients that experience serious adverse events from orally administered doses. Aubagio is an FDA & EMA approved once-daily oral tablet, developed by Genzyme, A Sanofi Company, that offers an effective alternative for patients suffering from Relapsing Multiple Sclerosis (RMS) Genzyme has partnered with Genpharm to commercialize Aubagio in the MENA region Juxtapid is an oral inhibitor of the microsomal triglyceride transfer protein (MTP) and is specifically indicated as an adjunct to a lowfat diet and other lipid-lowering treatments Aegerion Pharmaceuticals partnered with Genpharm to commercialize Juxtapid (Lomitapide) in the Levant region Staloral is a sublingual product for patients suffering from moderate to severe allergic rhinitis and/or mild to moderate allergic asthma Stallergenes has partnered with Genpharm to commercialize Staloral in U.A.E and Egypt NIOX, developed and distributed by Aerocrine/Stallergenes, is the first point-of-care medical device for measuring Fractional Exhaled Nitric Oxide (FeNO) Stallergenes partnered with Genpharm to commercialize NIOX in the U.A.E ChondroCelect is the only approved somatic cell therapy product from TiGenix, Belgium for repair of cartilage lesions in the knee using characterized viable autologous cartilage cells TiGenix NV partnered with Genpharm for commercialization of ChondroCelect in the GCC and Levant region PrenaTest is the first Non Invasive Prenatal Diagnostic (NIPD) developed by LifeCodexx in Germany for the detection of Down’s syndrome, Edwards Syndrome and Patau Syndrome LifeCodexx AG partnered with BioGen Medical and Genpharm for the commercialization and distribution of PrenaTest in Turkey, the Middle East and Gulf regions Confidential 8 Experienced Management Team Mr. Karim Smaira Co-founder & CEO Mr. Kamel Ghammachi Co-founder & Managing Partner 14 years of regional experience in Senior Executive roles in the Pharma industry More than 25 years of regional Pharma experience in Senior Executive roles within MNCs & Distributors. Launched and managed operations for several Biotech and rare disease products including (go to market strategies & funding) Established and Managed several regional offices in MENA Pharmaceutical entrepreneur with several start ups in the region, active member of several industry associations and business councils Wide expertise and network in emerging markets, in particular in the Middle East & North Africa Region as well as in South East Europe and Russia. Active member of several industry associations and business councils Honored by Rotary several times as Paul Harris Fellow for meeting outstanding personal, professional standards and charitable work. Member of the Diplomatic Circle in Geneva and Public speaker on industry matters Several awards recognizing successful businesses in MENA Confidential 9 Senior Non-Executive Board Mr. Franck Latrille CEO NextPharma Former Deputy CEO Merck-Serono, Executive Vice President International and emerging markets MerckSerono Former Head of product development at SERONO Mr. Rick Pudner Sheikh Yasser Naghi Mr. Dave Dimmell Board Director Emirates Islamic Bank Chairman of the Cigalah group, a leading pharmaceutical company and distributor in KSA & part of the Naghi holding Head of Corporate Banking HSBC Middle East; President and CEO of HSBC Korea Founding member of the Swiss Arab Postgraduate Clinical Acedemy (SAPCA in 2010) Director in Emirates Fund Managers (Jersey) Limited, and a founder member of Visa CEMEA Advisory Forum Board Member of several industrial and business groups in KSA Founding Partner & Managing Director of Genyx LLC consultancy, specializing in management consulting, staff engagement and alignment, employee assessment, senior executive coaching in several industries including Pharma. CEO of Emirates NBD; the largest regional bank by Assets Former Vice President of Pearson Higher Education, UK Former Vice President of Nelsom Education, Canada Confidential 10 Holistic Market Approach Physicians Government Programs Scientific Societies Patient Associations Purchasers Distributors Health Insurance Hospital Pharmacies 11 Delivering new drugs to MENA markets Genpharm masters product registration and commercialization across MENA Commercial and supply chain: Channels and networks Direct management of a network of distributors chosen over more than 40 years of experience Algeria Iran Private Some Gvt. Social Sec. Registration: Background and Insights Slow Reg. ~3 years Jordan KSA Yemen Lebanon Egypt Morocco Iraq UAE Qatar Tunisia Libya Avg. ~15-18months Bahrein Kuwait Logistics and distribution managed through well established sub-distributors with solid financials Direct relationship with purhcasing departments of major hospitals across MENA Rapid Reg ~12month Pre-registration sales for early returns Scrip generation through KOL management and strong network with major institutions Active role in Pharma forums in the region. Registration friendly environment in GCC Possibility for centralized registration procedure & fast track Pricing Harmonization & International referencing system Government coverage for nationals and privatization trend Established reputation of Genpharm management in the Pharma industry Confidential 12 Which Path to Maximal Strategic Value ? Long term ambitions : Growth and Sustainability 2012-2013: The party to talk to 2016 and >: Emerging pharma company leader 2014-2016: The spec pharma in progress Revenue Proprietary Branded Products Major Products Acquisition DX/Med Device Unit Business Development 10+ Products 2012 2013 2014 2015 2016 2017 13 Supportive MENA Pharmaceutical Market Middle East is one of the fastest growing pharma markets Central & Eastern Europe Size: € 48-56 bn CAGR (2013-17): 4% to 7% North America Size: € 276-298 bn CAGR (2013-17): 1% to 4% Western Europe Size: € 128-150 bn CAGR (2013-17): -2% to 4% Middle East Size: € 12-19 bn CAGR (2013-17): 12% to 14% Asia Pacific Size: € 202-216 bn CAGR (2013-17): 12% to 15% Africa Size: € 19-26 bn CAGR (2013-17): 7% to 10% Latin America Size: € 71-78 bn CAGR (2013-17): 10% to 13% High Growth (12% to 15%) High-Mid Growth (7% to 13%) Low-Mid Growth (4% to 7%) Low Growth (< 4%) Source: IMS Market Prognosis, Apr 2013 Note: Western Europe includes EU5 and rest of Western Europe; Size: 2013-2017, CAGR is between 2013-2017 Confidential 14 Strong MENA Macro Background MENA population growth to outpace other economic groups GDP per capita €, 2012 Population Growth (CAGR 2013-2018) Qatar 2.5% 2.0% Top Countries where Genpharm Operates 0.8% 1.0% 0.7% 0.5% 0.0% MENA Countries 18,540 KSA 17,931 Bahrain 17,223 17 30 31 33 7,539 Iran 5,270 Iraq 4,610 Jordan 3,567 Egypt 2,275 66 78 87 99 123 Developed Countries MENA Population, 2012 (mn) 450 400 Developing Countries 11 32,007 Oman Lebanon 2 35,653 UAE 1.5% Rank out of 188 countries 76,595 Kuwait 2.0% # 5,892 390 320 350 Russia 346 Developing Economies 300 250 Brazil China India 10,457 48 8,305 62 4,439 89 1,097 143 200 150 US 100 Developed Economies 50 37,805 Germany 10 30,611 UK 21 28,633 23 MENA Total Top 5 European Countries North America Global 7,572 Source: IMF Data Note: Developing Countries - China, India, Brazil & Russia; Developed Countries - US, Germany, UK & Canada; North America - US & Canada; KSA stands for Saudi Arabia; Top 5 European Countries – UK, Germany, France, Italy, Spain; MENA Countries - Algeria, Bahrain, Djibouti, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Mauritania, Morocco, Oman, Qatar, Saudi Arabia, Syria, Tunisia, UAE & Yemen; Conversion rate used across slides: 1 US$ = € 0.73118 Confidential 15 Strong MENA Macro Background Strong GDP growth provides an upside to healthcare spend Average GDP Growth (2013-2018) 8.0% 7.1% 7.2% 7.0% 6.1% 6.0% 5.8% 5.0% 5.0% 4.2% 4.2% 4.0% 3.8% 3.8% 3.7% 3.6% 3.5% 3.2% 4.0% 4.1% 3.1% 2.8% 3.1% 3.8% 2.9% 3.0% 1.9% 1.4% 2.0% 1.2% 1.0% 1 MENA India China Global Germany UK US Brazil Russia India China MENA Iran Kuwait Lebanon Egypt Algeria UAE Bahrain Oman Jordan Tunisia KSA Morocco Qatar Iraq 0.0% United States Health expenditure per capita: € 394 Health expenditure per capita: € 103 Health expenditure per capita: € 316 Health expenditure per capita: € 6,294 Health expenditure % of GDP: 4.6% Health expenditure % of GDP: 3.9% Health expenditure % of GDP: 5.2% Health expenditure % of GDP: 17.9% Source: IMF, World Bank Note: (1) MENA comprises Arab World and Iran; Health Expenditure - Data is for 2011, Healthcare expenditure per capita PPP (constant 2005 international $ converted to Euro) Confidential 16 Targeted and Focused Positioning for Genpharm …and in the orphan drug market which is consistently outgrowing the non orphan drug market Global Orphan Drugs Growth Global Orphan Drug Sales (€bn) 100.0 Global Non-Orphan Drugs Growth 92.9 22% 21% 90.0 80.0 86.3 80.4 18% 76.0 70.2 15% 70.0 65.8 13% 13% 60.7 60.0 57.0 50.5 50.0 9% 9% 40.0 8% 40.9 8% 33.6 8% 8% 44.6 7% 7% 6% 8% 6% 7% 27.8 30.0 5% 24.1 4% 4% 3% 20.0 4% 3% 2% 1% 0% 10.0 -3% 0.0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Source: EvaluatePharma, April 2013 Confidential 17 Targeted and Focused Positioning for Genpharm Genpharm is well positioned in market segments that offer a number of attractive commercial characteristics: The rare disease drugs are highly priced Genpharm operates in the niche, due to their research and development rare disease/Orphan Drug markets cost. Customers are typically government where the number of patients and High Value Products prescribing physicians is limited hospitals and similar institutions with a Institutional Customers substantial budget for their patients. Innovative products for unmet medical Genpharm manages all needs are given fast approval and stakeholders including Physicians, reimbursement pathway Patient groups, Payers and […] Distributors Need of a highly competent, Limited Number Of Prescribers / Physicians Fast track Registrations Robust local expertise & knowledge of the local processes Existing network with key decision maker centers and stakeholders evidence based selling and markets further helps to access promotion approach through a regional markets and help companies limited number of KAMs/MSLs Named Patient Sales with fast track registrations For unmet medical needs and specialty therapeutic, products can be purchased on a Name Patient Sales basis prior to registration. Fast track market access and market penetration. Early sales upside Confidential 18 Genpharm Summary Strong MENA Macro Background MENA’s fast growing economy High GDP per capita levels Rising income levels, increase in literacy levels, higher healthcare spend by government Supportive MENA Pharmaceutical Market Senior Non-Exec Board Middle East markets are expected to Genpharm has strong and high-profile board of non- grow from €12bn in 2012 to €19 executive members that bn in 2017, 12-14% growth is among bring along comprehensive experience GENPHARM Strong Management Team the highest in the world Targeted and Focused Positioning Genpharm operates in fast growing Orphan drug Genpharm has an experienced management team and extensive market that is expected to reach € 93 bn by network with key stakeholders 2018, while there are ~2.8 mn people in the Middle East that are affected by rare disease Confidential 19 For enquiries and contact: Dubai Biotechnology & Research Park P.O. Box 8145 Dubai, United Arab Emirates Tel: +971 4 4227010 info@genpharmservices.com www.genpharmservices.com
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