Laboratorios Farmaceuticos Rovi, S.a. · BME:ROVI

Laboratorios Farmaceuticos Rovi — Investor Presentation (2017)

16 slides from Laboratorios Farmaceuticos Rovi's investor presentation, 2017

  1. Slide 1: ROVI Enoxaparin Biosimilar: An opportunity worldwide

    ROVI Enoxaparin Biosimilar An opportunity worldwide

  2. Slide 2: Disclaimer

    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, th

  3. Slide 3: Index

    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. Decent

  4. Slide 4: Introduction

    Introduction • 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

  5. Slide 5: European Market: a clear opportunity

    European Market: a clear opportunity

  6. Slide 6: Enoxaparin: the market

    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 2

  7. Slide 7: Enoxaparin market in Europe

    Enoxaparin market in Europe Enoxaparin European market evolution (€Mn) Enoxaparin European market growth (% CER) 1.200 14% 5% 12,9% 12% 1.000 4% 10% 800 3% 8% 4,3% 600 1.027 2% 6% 909 898 858 854 400 4% 1% 0,4% 4,7% 0,9% 200 2% 0% 1,3% 2013 2014 2015 2016 0,5% -1,1% 0 0% 2012 2013 2014 2015 2016 -1%

  8. Slide 8: Biosimilar market in Europe (1/2)

    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 Filgra

  9. Slide 9: Biosimilar market in Europe (2/2)

    Biosimilar market in Europe (2/2) G-CSF (Filgrastim) (U) Epoetin (U) 100% 96% 98% 100% 88% 80% 85% 85% 85% 69% 67% 78% 79% 60% 52% 49% 51% 50% 40% Acute High potential 4% 20% 5% Diseases market. 0% 0% UK GERMANY ITALY POLAND PORTUGAL SPAIN AVERAGE UK GERMANY ITALY POLAND PORTUGAL SPAIN AVERAGE EU -2

  10. Slide 10: Enoxaparin worldwide market

    Enoxaparin worldwide market • Enoxaparin is the LMWH worldwide market leader. • In 2016, the sales of Enoxaparin reached €1.6Bn, with 2016 612*Mn units (2015 figure). % over total € Mn sales • The Enoxaparin worldwide market decreased -3.6% Europe 1.027 63% (CAGR 2012-2016) in terms of value. Elimin

  11. Slide 11: ROVI in the Enoxaparin market

    ROVI in the Enoxaparin market

  12. Slide 12: ROVI's competitive advantages

    ROVI’s competitive advantages • 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-ho

  13. Slide 13: Vertical integration

    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

  14. Slide 14: Commercial strategy

    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  Direct pres

  15. Slide 15: Decentralised procedure in Europe – National phase

    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

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