Vistin Pharma ASA
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Vistin Pharma ASA Oslo Børs 10 June 2015 1 COMPANY OVERVIEW This is Vistin Pharma Overview Key financials (NOK million) . Leading producer of active ingredients for diabetes medicine (metformin) and opiates for use in pain relief 242 and cough medicine 229 199 . Significant contract manufacturer (CMO) of solid dosage 170 form (tablets) products 155 131 . Production of codeine API since 1950, and production of metformin since 1969 22 20 . Headquartered in Oslo with production plants in Kragerø . Employs ~140 highly qualified people 2009 2010 2011 2012 2013 2014 . Debt free company Revenues B2B segment as reported in Weifa EBITDA . Kjell-Erik Nordby, previous CEO of Weifa ASA, is the CEO of Vistin Pharma Note that the historical reported figures do not include revenues or EBITDA from the CMO business area established in Vistin Pharma, or any stand alone costs for Vistin . Ole Enger is Chairman of the Board Pharma Vistin Pharma business areas Metformin Opioids 3rd party CMO 2 METFORMIN First line treatment of type 2 diabetes Vistin Pharma metformin overview Global manufacturing capacity – Metformin HCI Vistin Pharma ~8% . Producer of three different metformin API products - Metformin HCl (bulk API, “fine, dry powder”) - Metformin DC (“directly compressible”, a granulated pre- tablet form) ~35 000MT - Metformin tablets (ready for consumption) . Sales to reputable international pharmaceutical companies . Positioned as “high-value” producer in a low cost competitive market (many low cost Asian competitors) Historical reported revenues (NOK million) . State-of-the-art plant in Kragerø (Fikkjebakke) 150 +13% 142 . Certificated by all significant international regulatory bodies 111 101 88 . Positioned closely to major customers – can supply 80 customers within 24 hours 2009 2010 2011 2012 2013 2014 3 METFORMIN Diabetes - The Global Epidemic . Diabetes is estimated to grow 55% from 2013 to 2035 . Largest growth in developing economies Source: IDF (International Diabetes Federation) 4 METFORMIN Expected foreseeable annual metformin volume growth of 7-8% . Metformin consumption in 2013 Type 2 diabetes (T2D) corresponds to . Represents about 90% of diabetes cases - treatment of ~50% of diagnosed population and - ~25% of total population with T2D . 46% of total T2D population estimated to be undiagnosed . Expected 7-8% p.a. growth explained by: . Significant portion of diagnosed population - Average daily dose increase from 500/850mg currently not receiving recommended to 1000mg dosage/therapy - Increased number of diagnosed patients - Increased number of treated patients Metformin . Plain metformin is the standard 1st line therapy for T2D . Metformin combined with other APIs are 2nd and 3rd line therapy . Fixed dose combination products containing metformin represent about 10% of metformin volume 5 METFORMIN Value proposition in the metformin market Two key characteristics placing Vistin Pharma in a unique position within the metformin market Operational excellence Aim to dominate the high value customer segment . Provides among the purest and most free-flowing qualities . Focus on reliable supply and consistent high quality API of metformin in the global market . Supplies customized products and services . Measures to be taken to further increase the product quality . Excellent customer support with short lead times and capacity . Sufficient capacity and long term delivery . Capacity can easily be expanded by +300- 400MT up to 3500MT/year with limited investments - Expand to 5000 MT when sufficient high value volume is secured . Multi-source suppliers secure delivery of critical raw material . Strong risk based management . Transform the underlying cost structure through scale economies EXCELLENT QUALITY SHORT LEADTIME RELIABILITY PREMIUM VALUE ADDED OFFER PRICE 6 OPIOIDS Major opioids “powder-to-pill” supplier Overview Global manufacturing capacity . Drugs delivered from opium and their chemically Codeine market Pholcodine market related derivatives Vistin Pharma Vistin Pharma ~7% ~16% - Opioids is a group of natural and synthetic drugs with morphine-like properties . The competitive market for opioids production is heavily influenced by tight controls and regulations ~400MT ~10MT . Vistin Pharma produces two APIs in the opioid sector - Codeine (analgesics and cough syrup) - Pholcodine (cough syrup) . Also produces codeine tablets (FDF) Historical reported revenues (NOKm) - First commercial sales of codeine tables in Q4 2014 NOK million . Production in Kragerø (Gruveveien) +9% . Customers are leading pharmaceutical companies 82 75 worldwide 71 57 58 . Few raw material suppliers (and API competitors) due to the high barriers to entry (regulatory requirements) 2010 2011 2012 2013 2014 7 OPIOIDS Stable growth in the use of opioids Growth driven by developing countries Competitive situation - high entry barriers . Aging population and rising prevalence of diseases . Only a few companies are allowed to manufacture - Demand, measured by defined daily doses, has increased 3.5 opioids times in 20 years (CAGR of ~6.5%) . Strong international control and regulations by INCB . North America dominates the global market for opioids . Several of the manufacturers have strong, protected . Asia expected to be the fastest growing market the positions in their home markets due to import next years restrictions - Current shortage of opioid medication and fast economic . Few European opioid API suppliers development . Raw material supply controlled by a small number of producers GLOBAL CODEINE API PRODUCTION +6% 414 382 42 340 323 331 36 14 78 19 21 62 70 53 80 295 256 258 284 224 2008 2009 2010 2011 2012 Other uses Utilized to make other APIs Consumed as Codeine Source: INCB statistics 8 OPIOIDS Unique position in today’s codeine market driven by… Vistin Pharma: …the industry’s unusual key features… . Established market share of ~30% in the UK – . Tight regulatory controls create high entry barriers the largest codeine market in Europe - eliminates the risk of low cost Asian competition as prevailing . Codeine production since 1950 in other API industries . Very few raw material suppliers – an oligopoly . Very good relationship with the regulators resulting in swift import/export licenses . Is the world largest independent manufacturer of codeine phosphate API . Aim for global codeine business leadership and to become a fully integrated supplier …and the Company’s in-house FDF capabilities . The customers (codeine FDF marketers) either make their own FDFs or are supplied under B2B contracts by CMO . All major NRM producers also produce codeine API… . …but none of them have in-house FDF capabilities . Vistin Pharma is uniquely positioned in the value chain through both API and FDF manufacturing capabilities (API supplier with in-house FDF capabilities) 9 3RD PARTY CMO Vistin Pharma - a CMO tablet manufacturer Vistin Pharma has a CMO agreement with Weifa Preliminary estimated key financials . Contract manufacturer agreement (CMO) with Weifa for 2015 full year basis the production of Weifa’s key pain relief brands . Revenues: approximately NOK 110 - 120 million - The first term duration of five years with extension option . EBITDA: approximately NOK 8 million . Key drivers for the CMO industry is: - Change in regulatory frameworks - Margin pressure - Efficiency gap compared to other industries CAPACITY ILLUSTRATED . Production at the company’s plant in Gruveveien, Kragerø - Estimated production of ~650 million tablets in 2015 - Vistin Pharma can produce up to ~950 million tablets annually without any significant new investments Current Capacity capacity potential New capacity from new shifts and/or new investments Free capacity Capacity utilization with current agreements 10 .