genpharm 11 nov 2013

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gENPHARMA

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  • Management Presentation!

  • Confidential! 2!

    Company Overview!Strong progress since inception!

    Oct, 2012!

    Nov, 2012!Signs agreement for commercialization of

    ChondroCelect!

    Stallergenes SA and Genpharm Services extend

    collaboration to Egypt!

    Signs promotional agreement for Stallergenes AIT treatments in the UAE!

    Genpharm starts operations!

    April, 2012!

    Signs commercialization and distribution agreement

    for PrenaTest!

    Dec, 2012!

    Feb, 2013!

    Signs commercializaton agreement with Genzyme!

    for Aubagio in MS!

    Apr, 2013!

    Sponsors orphan drug meeting in Washington

    DC, US!

    Apr, 2013!

    Multiple-year agreement with Aegerion

    Pharmaceutical!

    Jun, 2013!

    Holds ASPIRE! event for MENA

    Neurologists!

    Oct, 2013!

    Sponsors orphan drug meeting

    Geneva!

    Nov, 2013!

  • Confidential! 3!

    Company Overview!Business overview!

    Overview!

    Algeria! Libya! Egypt! Saudi !Arabia!

    Yemen!Oman!

    Morocco! Iran!

    Womens Health!

    Immunology &!Infectious Disease! Neurology! Rare Disease!

    Specialty Therapeutic Focus!

    Genpharm is a specialty pharmaceutical marketing and consulting company focused on niche therapeutics and diagnostics for rare disease!

    It provides fast and sustainable market access into the MENA (Middle East & North Africa) region to its strategic partners including regulatory and medical!

    It provides Business Development and market analysis for companies looking to evaluate the potential of their portfolio in MENA. !

    It acts as the representative agent for rare disease, biotech and specialty pharma companies looking to enter or to expand in the MENA!

    Algeria Libya Egypt Saudi !

    Arabia

    Morocco Iran

    Tunisia Syria Lebanon

    Jordan Iraq

    Yemen

    UAE!(Dubai, Headquarter)

    Kuwait Bahrain

    Qatar

    MENA

    Geographical Presence!

  • Confidential! 4!

    Company Overview!Mission, Vision & Values!

    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.!

    We strive to be the partner of choice for multinational

    healthcare !and pharmaceutical companies !expanding into the Middle East

    and North Africa region. !!

    We aim to consistently differentiate ourselves by

    serving all of our stakeholders through evidence based

    medicine. !

    Our Vision! Mission Statement!

    Patient Care!

    We are dedicated to patient care

    and quality of life!

    Integrity!

    We act honestly, with inclusivity

    and respect!

    Innovation!

    We offer unique and sustainable

    solutions!

    Accountability!

    We are committed, reliable and

    results focused!

    Teamwork!

    We are positive, professional and

    transparent!

    Iran!

    Core Values!

  • Confidential! 5!

    Company Overview!

    Identify business potential for the product portfolio!

    Registration and fast-track market access strategies!

    Raise disease awareness!Secure funding!Stakeholders management!

    Competent & trained sales force !

    Evidence based medicine!Advocacy building & KOL

    management!Scientific publications &

    events!

    Vast network of trusted and experienced importers/ distributors!

    Solid financial background!Ensures geographic reach!Ensures adapted distribution

    channels to the product portfolio!

    MARKET ACCESS! SCIENTIFIC DIFFERENTIATION! DISTRIBUTION & PARTNERSHIP!

    Genpharms Pillars!

  • Confidential! 6!

    Company Overview!Products & services overview!

    Aubagio! Juxtapid! Staloral! NIOX !

    Sustainable market access solutions that provide long-term value!

    ChondroCelect! NIPT PrenaTest!

    Consultancy! Specialty Pharma!

    Identify business potential! Recommend appropriate business & operations models! Recommend strategy & organization! Formulate adapted market access strategies!

    Registration ! Marketing, Promotion & sales force effectiveness! Fast track market penetration through NPS! Importation & distribution & Tender participation! Medical & PV services!

    Current Partners and Products!

    Genpharm Services!

    Global Pharmaceutical Manufacturers!

  • Confidential! 7!

    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 low-fat 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 Downs 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!

    Portfolio overview!

    Company Overview!

  • Confidential! 8!

    GENPHARM!

    MENAs fast growing economy! High GDP per capita levels! Rising income levels, increase in literacy levels,

    higher healthcare spend by government!

    !Strong MENA

    Macro Background!

    !

    Middle East markets are expected to grow from 12bn in 2012 to 19 bn in 2017, 12-14% growth is among the highest in the world!

    Supportive MENA Pharmaceutical

    Market!

    Genpharm has strong and high-profile board of non-executive members that bring along comprehensive experience!

    Senior Non-Exec Board!

    Genpharm has an experienced management team and extensive network with key stakeholders !

    !Strong

    Management Team !

    !

    Key Highlights !

    Genpharm operates in fast growing Orphan drug market that is expected to reach 93 bn by 2018, while there are ~2.8 mn people in the Middle East that are affected by rare disease!

    !Targeted and

    Focused Positioning!

    !

  • Confidential! 9!

    7,572!

    28,633!30,611!

    37,805!

    1,097!4,439!

    8,305!10,457!

    5,892!

    2,275!3,567!4,610!5,270!7,539!

    17,223!17,931!18,540!

    32,007!35,653!

    76,595!

    Global!

    UK!Germany!

    US!

    India!China!Brazil!

    Russia!

    MENA!

    Egypt!Jordan!

    Iraq!Iran!

    Lebanon!Bahrain!

    KSA!Oman!

    UAE!Kuwait!Qatar!

    GDP per capita , 2012!MENA population growth to outpace other economic groups!

    Strong MENA Macro Background!

    2.0%!

    0.8%!0.7%!

    0.0%!

    0.5%!

    1.0%!

    1.5%!

    2.0%!

    2.5%!

    MENA Countries! Developing Countries! Developed Countries!

    Top Countries where

    Genpharm Operates!

    Developed Economies!

    Developing Economies!

    Population Growth (CAGR 2013-2018)!

    390 !

    491 !

    346 !

    - !

    100 !

    200 !

    300 !

    400 !

    500 !

    600 !

    MENA Total! Top 5 European Countries!

    North America!

    Population, 2012 (mn)!

    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 - Germany, France, Italy, Spain, & Netherlands!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!

    2!

    11!

    17!

    30!

    31!

    33!

    66!

    78!

    87!

    99!

    123!

    48!

    62!

    89!

    143!

    10!

    21!

    23!

    #! Rank out of 188! countries!

  • Confidential! 10!

    Strong MENA Macro Background!

    7.2%!

    6.1%!5.0%!

    4.2%! 4.2%! 4.0%! 3.8%! 3.8%! 3.7%! 3.6%!3.5%! 3.2%! 2.8%!

    1.4%!

    4.1%!

    7.1%!

    5.8%!

    3.1%! 3.1%! 2.9%!

    1.9%!1.2%!

    3.8%!

    0.0%!1.0%!2.0%!3.0%!4.0%!5.0%!6.0%!7.0%!8.0%!

    Iraq!

    Qata

    r!

    Mor

    occo

    !

    KSA!

    Tuni

    sia!

    Jord

    an!

    Oman

    !

    Bahr

    ain!

    UAE!

    Alge

    ria!

    Egyp

    t!

    Leba

    non!

    Kuwa

    it!

    Iran!

    MEN

    A!

    Chin

    a!

    Indi

    a!

    Russ

    ia!

    Braz

    il!

    US!

    UK!

    Germ

    any!

    Glob

    al!

    Average GDP Growth (2013-2018)!Strong GDP growth provides an upside to healthcare spend!

    Health expenditure!per capita:! 394!

    Health expenditure! % of GDP:! 4.6%!

    Health expenditure!per capita:! 103!

    Health expenditure! % of GDP:! 3.9%!

    Health expenditure!per capita:! 316!

    Health expenditure! % of GDP:! 5.2%!

    Health expenditure!per capita:! 6,294!

    Health expenditure! % of GDP:! 17.9%!

    MENA1! India! China! United States!

    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)!

  • Western Europe!Size: 128-150 bn!CAGR (2013-17): -2% to 4%!

    Middle East!Size: 12-19 bn!CAGR (2013-17): 12% to 14%!

    Africa!Size: 19-26 bn!CAGR (2013-17): 7% to 10%!

    Central & Eastern Europe!Size: 48-56 bn!CAGR (2013-17): 4% to 7%!

    Asia Pacific!Size: 202-216 bn!CAGR (2013-17): 12% to 15%!

    North America!Size: 276-298 bn!CAGR (2013-17): 1% to 4%!

    Latin America!Size: 71-78 bn!CAGR (2013-17): 10% to 13%!

    Supportive MENA Pharmaceutical Market!Middle East is one of the fastest growing pharma markets!

    11!

    Low Growth!(< 4%)!

    High-Mid Growth!(7% to 13%)!

    High Growth !(12% to 15%)!

    Low-Mid Growth!(4% to 7%)!

    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!

  • Confidential! 12!

    Genpharm is well positioned inthe nichemarket segments!

    Rare Disease! It is a type of disease that influence a small percentage of population! Majority rare diseases are genetic and have an impact on an individual throughout their life, even if

    symptoms do not immediately appear! These type of diseases appear in early life and near about ~30% children die within first 5 years!

    Orphan Drugs!

    An orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease!

    The development of orphan drugs has been financially incentivized through US law via the Orphan Drug Act of 1983!

    The National Organization for Rare Disorders (NORD) estimates 30 million Americans suffer from 7,000 rare diseases. In the MENA regions estimates are around 2.8mio sufferers!

    To date, 425 indication designations covering 347 drugs have been approved ! Global market for orphan drug is estimated at 65.8 bn with US dominating with ~50% share! Highly fragmented market for orphan drug is estimated to grow at a CAGR of ~7% through 2013-2018! Top 10 largest orphan drugs manufacturing companies account for ~33% share of global market! Strong local presence and market knowledge along with good legal relations act a catalyst in this

    organization! These drugs have exclusive market rights with least competitive drug prices (10 in the EU and 7 in the

    US)! Orphan drugs fall under low volume and high price category!

    Specialty drugs!

    These are the drugs that are used to treat medical conditions including multiple sclerosis, hemophilia, hepatitis and rheumatoid arthritis!

    These forms the part of rapidly growing drugs category that are the result of sustained advances in drug development technology!

    Specialty drugs are mostly injectable or infused medicines, but may also include oral medicines! These are expensive with limited access with sometimes complicated treatment and compliance issues!

    Targeted and Focused Positioning for !Genpharm!

  • Confidential! 13!

    59%!42%! 32%! 34%! 38%! 40%!

    34%!49%!

    55%! 56%! 52%! 48%!

    6%! 8%! 10%! 8%! 8%! 10%!1%! 1%! 3%! 1%! 2%! 2%!

    0%!

    20%!

    40%!

    60%!

    80%!

    100%!

    UAE! KSA! Egypt! Jordan! Morocco! Tunisia!

    Segment Value by Country!

    Original Brands! Branded Generics ! Others! Unbranded Generics!

    Targeted and Focused Positioning for !Genpharm!Genpharm is purposely positioned in the original brands market!

    Unbranded Generics!

    Branded Generics!

    Unprotected Originals!

    Protected widely RX!

    Niche Specialty!

    Commodity ! ! ! Differentiated!

    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!

    Business Model Characteristics for different product types!

    30% 27% 22% 18% 27% 18%

    57% 61% 60% 61% 54%

    52%

    12% 12% 16% 18% 17% 29%

    2% 1% 2% 3% 2% 2%

    0%

    20%

    40%

    60%

    80%

    100%

    UAE KSA Egypt Jordan Morocco Tunisia

    Segment Volume by Country

    Original Brands Branded Generics Others Unbranded Generics Source: IMS MIDAS June 2012, Licensing Data, Rx bound!Note: RX = Protected Formula/Product!

  • Confidential! 14!

    and in the orphan drug market which is consistently outgrowing the non orphan drug market!

    Targeted and Focused Positioning for !Genpharm!

    24.1!27.8!

    33.6!

    40.9! 44.6!

    50.5!57.0!

    60.7!

    65.8!70.2!

    76.0!80.4!

    86.3!

    92.9!

    18%!

    15%!

    21%!22%!

    9%!

    13%! 13%!

    6%!

    8%!

    7%!

    8%!

    6%!

    7%! 8%!

    8%! 8%!9%!

    7%!

    2%!1%!

    5%!

    -3%!

    0%!

    3%!4%! 4%! 4%! 3%!

    0.0!

    10.0!

    20.0!

    30.0!

    40.0!

    50.0!

    60.0!

    70.0!

    80.0!

    90.0!

    100.0!

    2005! 2006! 2007! 2008! 2009! 2010! 2011! 2012! 2013! 2014! 2015! 2016! 2017! 2018!

    Global Orphan Drug Sales (bn)! Global Orphan Drugs Growth! Global Non-Orphan Drugs Growth!

    Source: EvaluatePharma, April 2013!

  • The rare disease drugs are highly priced due to their research and development cost. Customers are typically government hospitals and similar institutions with a substantial budget for their patients.!

    Confidential! 15!

    []

    Fast track !Registrations!

    Limited Number !Of Prescribers / !

    Physicians!

    Institutional !Customers!

    !

    Named Patient !Sales!

    High Value !Products!

    Genpharm is well positioned in market segments that offer a number of attractive commercial characteristics:! Genpharm operates in the niche,

    rare disease/Orphan Drug markets where the number of patients and prescribing physicians is limited!

    Innovative products for unmet medical needs are given fast approval and reimbursement pathway!

    Robust local expertise & knowledge of the local processes!

    Existing network with key decision maker centers and stakeholders further helps to market and fast track registrations!

    Genpharm manages all stakeholders including Physicians, Patient groups, Payers and Distributors!

    ! Need of a highly competent,

    evidence based selling and promotion approach through a limited number of KAMs/MSLs!

    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 !

    Targeted and Focused Positioning for !Genpharm!

  • Confidential! 16!

    Strong Management Team (1/2)!

    14 years of regional experience in Senior Executive roles in the Pharma industry!

    Launched and managed operations for several Biotech and rare disease products including (go to market strategies & funding)!

    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!

    Member of the Diplomatic Circle in Geneva and Public speaker on industry matters!

    Mr. Karim Smaira,!Co-founder & CEO!

    More than 25 years of regional Pharma experience in Senior Executive roles within MNCs & Distributors.!

    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!

    Honored by Rotary several times as Paul Harris Fellow for meeting outstanding personal, professional standards and charitable work.!

    Several awards recognizing successful businesses in MENA!

    Mr. Kamel Ghammachi,!Co-founder & Managing Partner!

  • Confidential! 17!

    Mr. Karim Smaira,!Co-founder & CEO!

    Mr. Kamel Ghammachi,!Co-founder & Managing Partner!

    Strong Management Team (2/2)!

    Yassin Taha,!Market Access!

    Mohamed Nabil Al-Nayeb, !Sales!

    Dalia Kamal,!Marketing!

    Magdy Makram,!Commercial Operations!

    Ashwathy Anil,!Business Development!

  • Confidential! 18!

    CEO NextPharma! Former Deputy CEO

    Merck-Serono, Executive Vice President International and emerging markets Merck-Serono!

    Former Head of product development at SERONO!

    CEO of Emirates NBD; the largest regional bank by Assets!

    Board Director Emirates Islamic Bank!

    Head of Corporate Banking HSBC Middle East; President and CEO of HSBC Korea!

    Director in Emirates Fund Managers (Jersey) Limited, and a founder member of Visa CEMEA Advisory Forum!

    Chairman of the Cigalah group, a leading pharmaceutical company and distributor in KSA & part of the Naghi holding!

    Founding member of the Swiss Arab Postgraduate Clinical Acedemy (SAPCA in 2010)!

    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.!

    Former Vice President of Pearson Higher Education, UK!

    Former Vice President of Nelsom Education, Canada!

    Mr. Franck Latrille!

    Mr. Rick !Pudner!

    Sheikh Yasser Naghi!

    Mr. Dave !Dimmell!

    Senior Non-Executive Board!

  • For enquiries and contact:!!!!

    Dubai Biotechnology & Research Park !P.O. Box 8145!

    Dubai, United Arab Emirates!Tel: +971 4 4227010!

    [email protected]!www.genpharmservices.com!

    !

    services