Presentation on the biosimilar Enoxaparin of ROVI

ROVI Enoxaparin Biosimilar An opportunity worldwide 1 Disclaimer This document has been prepared by Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”), solely for its use during the attached presentation. The information and each of the opinions and statements contained in this document have not been verified by independent experts and, therefore, no guarantee is provided of the impartiality, accuracy, completeness or precision of the information or opinions and statements contained in this presentation. The Company and its advisors do not assume responsibility for any damage or losses that may arise from the use of this document or the information it contains. This document does not constitute an offer or invitation to acquire or subscribe shares, in accordance with the Spanish Securities Market Law and its implementing regulations. Moreover, this document does not constitute an offer to purchase, sell or exchange securities, a solicitation of any offer to purchase, sell or exchange securities, a solicitation of any kind of voting rights, or approval in the United States of America or any other jurisdiction. Neither this document nor any part of it are of a contractual nature, and they cannot be used to form part or construe any agreement or any kind of undertaking. This presentation may contain information and statements or declarations with future projections regarding ROVI. The future projections do not constitute historical facts and are generally identifiable by the use of terms such as “expects”, “anticipates”, “believes”, “intends”, “estimates” and similar expressions. In this regard, although ROVI believes that the expectations contained in such statements are reasonable, the investors and holders of ROVI shares are advised that the information and future projections are subject to risks and uncertainties, a large part of which are difficult to foresee, and which are, in general, out of ROVI’s control. These risks could cause the results and real development to differ substantially from those expressed, implicit or projected, in the information and future projections. Among these risks and uncertainties include those identified in the documents submitted by ROVI to the Spanish Securities Exchange Commission (Comisión Nacional del Mercado de Valores), which are available to the public. It is recommended that investment decisions not be taken based on the future projections, which refer exclusively to the date on which they were publicised. All the future projections contained below and made by ROVI or any of its directors, managers, employees or representatives are expressly subject to the above warnings. The future projections included in this presentation are based on the information available on the date hereof. Except when legally required, ROVI does not assume any obligation to update its statements or review the future projections, even if new data is published or new facts arise. 2 Index Introduction 1. European market: a clear opportunity 1. Enoxaparin: the market 2. Enoxaparin market in Europe 3. Biosimilar market in Europe 4. Enoxaparin worldwide market 2. ROVI in the Enoxaparin market 1. ROVI’s competitive advantages 2. Vertical integration 3. Commercial strategy 4. Decentralised procedure in Europe – National Phase 3 • ROVI’s history has been linked to heparins since it was founded. • Bemiparin, a second generation Low Molecular Weight Heparin (LMWH): ROVI’s first major R&D milestone.  Present in more than 55 countries.  Second market position in Spain with a market share of 28%. • Development of a biosimilar of enoxaparin: logical evolution of our business.  Marketing authorisation requested in 2014 in Europe.  Validation and starting of the assessment process in Feb 2015.  Decentralised procedure (DCP) used with Germany as Reference State Member. • DCP of ROVI's biosimilar of Enoxaparin completed with a positive outcome in Feb 2017. • Starting of the National Phase in 26 countries in the EU (Lithuania not included), which is expected to be completed with the granting by the competent local authorities of the marketing authorization.  This National Phase could last from three to ten months. • With the biosimilar of enoxaparin, ROVI:  Is aiming to become one of the European top players in a €1Bn* market where no biosimilars have been launched yet.  Could increase its footprint in emerging markets, with a potential market of €0.5Bn*.  Has a significant competitive advantage thanks to vertical integration. Introduction *Source: Sanofi 2016 European Market: a clear opportunity 5 Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe).  In Europe, Clexane is the leading anti-thrombotic and no biosimilars have been launched yet (although patent expired). The market achieved €1.0Bn* sales in 2016.  In Spain, Clexane has a market share of 63% vs. 28% of Hibor.  In Europe: Other Enoxaparin biosimilars (Techdow and Pharmathen) were approved. Limited number of additional competitors is expected. USA Europe Generics on the market No biosimilars on the market Other biosimilars approved in Europe (Techdow and Pharmathen) ROVI’s biosimilar started the National Phase after DCP completed with a positive outcome Momenta/Sandoz (Novartis) since 2010 Amphastar, Actavis (acquired by TEVA) since 2012 New launches in 2015: TEVA and Fresenius (Sanofi’s license) Market *Source: Sanofi annual results 854 858 898 909 1.027 0,5% 4,7% 1,3% 12,9% 0% 2% 4% 6% 8% 10% 12% 14% 2012 2013 2014 2015 2016 0 200 400 600 800 1.000 1.200 6 Enoxaparin market in Europe Source: Sanofi annual results * QuintilesIMS, 2015 Note: units (U) are related to pre-filled syringes. • Europe is the largest Enoxaparin market worldwide with€1,027Mn and 396Mn* units (2015 figure). • In 2016, Europe represented 63% (in value) of total Enoxaparin sales. • The Enoxaparin European market increased +4.7% (CAGR 2012-2016) in terms of value. Eliminating the effect of exchange rate fluctuations, the European Enoxaparin market decreased by 1.1% in 2016. • Top 5 largest markets in Europe (France, Germany, Italy, Spain and UK) represent 73%* in units. Enoxaparin European market evolution (€Mn) Enoxaparin European market growth (% CER) 0,9% 4,3% 0,4% -1,1% 2013 2014 2015 2016 -1% 0% 1% 2% 3% 4% 5% Note: Sanofi reported sale figures in Europe in 2016 compared to sale figures in Western Europe the previous years CER: Constant Exchange Rates or constant currencies: eliminate the impact of exchange rate fluctuations when calculating sale annual variations. 7 Source: QuintilesIMS Note: units (U) are related to pre-filled siringes Somatropin, Epoetin, Filgrastim and Infliximab are hospital biosimilars. Biosimilar market in Europe (1/2) • Penetration of biosimilars varies depending on acute and chronic diseases, and the active principle. • Epoetin (acute) reached a market share of 60% and 30% the first year, after the launch of the product, in Germany and Spain respectively. • Penetration of Filgrastim (acute), the first year, was of 40% in Spain and 80% in UK. Biosimilars’ market share evolution per country (U) First biosimilar entrance Nº compet. 2007 1 2006 1 2007 1 2007 1 2007 1 First biosimilar entrance Nº compet. 2009 1 2007 3 2009 2 2009 1 2009 2 First biosimilar entrance Nº compet. 2009 5 2008 3 2009 4 2009 4 2008 6 8 Biosimilar market in Europe (2/2) 98% 78% 88% 85% 85% 79% 85% 4% -30% -24% -47% -87% -41% -32% -100% -50% 0% 50% 100% UK GERMANY ITALY POLAND PORTUGAL SPAIN AVERAGE EU GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF) MS (%) Biosimilar vs Reference Product GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF) Biosimilar Price Reduction (%) vs Reference Product 5% 69% 52% 96% 67% 49% 51% -7% -53% -11% -67% -71% -30% -33% -80% -60% -40% -20% 0% 20% 40% 60% 80% 100% UK GERMANY ITALY POLAND PORTUGAL SPAIN AVERAGE EU EPOETIN (EPO) MS (%) Biosimilar vs Reference Product EPOETIN (EPO) Biosimilar Price Reduction (%) vs Reference Product 9% 10% 11% 78% 15% 13% 13% 0% -4% -1% -38% -20% -2% -8% -60% -40% -20% 0% 20% 40% 60% 80% 100% UK GERMANY ITALY POLAND PORTUGAL SPAIN AVERAGE EU ANTI-TUMOR NECROSIS FACTOR (Anti-TNF) MS (%) Biosimilar vs Reference Product ANTI-TUMOR NECROSIS FACTOR (Anti-TNF) Biosimilar Price Reduction (%) vs Reference Product Acute Diseases Chronic Diseases High potential market. Limited potential market as chronic diseases have higher resistance to changing medicines. G-CSF (Filgrastim) (U) Epoetin (U) Anti TNF (Infliximab) (U) HGH (Somatropin) (U) 17% 26% 23% 99% 4% 29% 35% -26% 3% -17% -47% -33% -19% -19% -60% -40% -20% 0% 20% 40% 60% 80% 100% 120% UK GERMANY ITALY POLAND PORTUGAL SPAIN AVERAGE EU HUMAN GROWTH HORMONE (HGH) MS (%) Biosimilar vs Reference Product HUMAN GROWTH HORMONE (HGH) Biosimilar Price Reduction (%) vs Reference Product Source: QuintilesIMS, June 2016 Note: units (U) are related to pre-filled syringes Somatropin, Epoetin, Filgrastim and Infliximab are hospital biosimilars. 1.893 1.703 1.699 1.719 1.636 -10,1% -0,2% 1,2% -4,8% -12% -10% -8% -6% -4% -2% 0% 2% 2012 2013 2014 2015 2016 0 400 800 1.200 1.600 2.000 9 Enoxaparin worldwide market • Enoxaparin is the LMWH worldwide market leader. • In 2016, the sales of Enoxaparin reached€1.6Bn, with 612*Mn units (2015 figure). • The Enoxaparin worldwide market decreased -3.6% (CAGR 2012-2016) in terms of value. Eliminating the effect of exchange rate fluctuations, the Enoxaparin worldwide market decreased by 1.7% in 2016. • Europe is the biggest market with a market share (in value) of 63%. Enoxaparin worldwide market evolution (€Mn) -7,2% 2,1% -0,5% -1,7% 2013 2014 2015 2016 -10% -8% -5% -3% 0% 3% 5% Enoxaparin worldwide market growth (% CER) Source: Sanofi annual results * QuintilesIMS, 2015 Note: units (U) are related to pre-filled syringes. € Mn % over total sales Europe 1.027 63% USA 54 3% Emerging markets 462 28% Rest of the world 93 6% Total worldwide sales 1.636 100% 2016 CER: Constant Exchange Rates or constant currencies: eliminate the impact of exchange rate fluctuations when calculating sale annual variations. ROVI in the Enoxaparin market • ROVI has competitive advantages within the LMWHs market:  Heparin has been the main focus of the company since its foundation: deep knowledge of LMWH products.  Present in > 55 countries: excellent knowledge of the LMWH market.  Owner of the dossier and the know-how.  Important player with a market share of 28% in Spain.  Vertically integrated manufacturing process:  IP/ registration Owner of the dossier  API  Filling & Packaging  Distribution ROVI sales force/International & domestic partners • ROVI aims to be a key player of the LMWH market in the long term. 11 ROVI’s competitive advantages 12 Vertical integration • ROVI will manufacture the active principle and will fill and package its biosimilar of Enoxaparin. • San Sebastián de los Reyes plant approved by authorities from Europe. • Julián Camarillo plant approved by authorities from Europe, USA, Korea, Brazil and Gulf countries. •€17.2Mn invested in the last 3 years to increase capacity in the plants. 12 • Limited initial capacity subject to regulatory variations for the first 18/20 months. • Potential additional investments in the future to increase capacity. 13 Commercial strategy • ROVI obtained the approval for two registrations in Europe. Depending on the market evolution, ROVI may use one registration to grant licenses to third parties. • ROVI expects to follow a double strategy in distributing the biosimilar of enoxaparin, based on: • ROVI is in advanced negotiations with a partner in USA. Once the agreement is reached,  It will specify dates for the resubmission of the dossier.  It will use the European information for the resubmission. • Distribution agreements (subject to marketing authorization to be granted by local authorities in each country) already signed to commercialize the product in 26 countries (outside EU and USA).  Direct presence in some countries  Partnership with domestic and/or international players  ROVI will have its own sales force in some countries.  Decision of countries where ROVI would have direct presence yet to be taken.  Distribution through domestic and/or international players.  Potential agreements based on up-front fees, royalties and milestones. ROVI Potential European Markets 14 Decentralised procedure in Europe – National phase • End of the Decentralised procedure with positive outcome. • Germany acted as Reference Member State. • ROVI obtained the approval for two registrations in Europe. • Starting of the national phase of the registration process.  26 countries of the European Union (Lithuania is not included).  National translation of: • Summary of Product Characteristics (SmPC) • Package Leaflet (PL) • Labelling  Presumably granting of national Marketing Authorisations. • Pricing and reimbursement in each country*. • Length of the process: 3 to 10 months. * Only for countries where prices are regulated. In some countries such as UK and Germany prices are free.

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