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ROVI Enoxaparin Biosimilar An opportunity worldwide

Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

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Page 1: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

ROVI Enoxaparin BiosimilarAn opportunity worldwide

Page 2: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

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Disclaimer

This document has been prepared by Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”), solely for its use during theattached presentation.

The information and each of the opinions and statements contained in this document have not been verified by independent expertsand, therefore, no guarantee is provided of the impartiality, accuracy, completeness or precision of the information or opinions andstatements 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 orthe information it contains.

This document does not constitute an offer or invitation to acquire or subscribe shares, in accordance with the Spanish SecuritiesMarket Law and its implementing regulations. Moreover, this document does not constitute an offer to purchase, sell or exchangesecurities, a solicitation of any offer to purchase, sell or exchange securities, a solicitation of any kind of voting rights, or approval inthe 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 agreementor any kind of undertaking.

This presentation may contain information and statements or declarations with future projections regarding ROVI. The futureprojections 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 holdersof ROVI shares are advised that the information and future projections are subject to risks and uncertainties, a large part of which aredifficult to foresee, and which are, in general, out of ROVI’s control. These risks could cause the results and real development to differsubstantially from those expressed, implicit or projected, in the information and future projections. Among these risks anduncertainties 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 onwhich 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 arebased on the information available on the date hereof. Except when legally required, ROVI does not assume any obligation to updateits statements or review the future projections, even if new data is published or new facts arise.

Page 3: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

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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

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• 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&Dmilestone.

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 tobe 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 biosimilarshave 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

Page 5: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

European Market: a clear opportunity

Page 6: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

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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 launchedyet (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 marketOther biosimilars approved in Europe (Techdow and Pharmathen)

ROVI’s biosimilar started the National Phase after DCP completed with apositive outcome

Momenta/Sandoz (Novartis) since 2010Amphastar, Actavis (acquired by TEVA) since 2012

New launches in 2015: TEVA and Fresenius (Sanofi’s license)

Market

*Source: Sanofi annual results

Page 7: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

854

85

8

898

90

9

1.0

27

0,5%

4,7%

1,3%

12,9%

0%

2%

4%

6%

8%

10%

12%

14%

2012 2013 2014 2015 20160

200

400

600

800

1.000

1.200

6

Enoxaparin market in Europe

Source: Sanofi annual results* QuintilesIMS, 2015Note: 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. Eliminatingthe 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 figuresin Western Europe the previous years

CER: Constant Exchange Rates or constant currencies: eliminate the impactof exchange rate fluctuations when calculating sale annual variations.

Page 8: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

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Source: QuintilesIMSNote: units (U) are related to pre-filled siringesSomatropin, 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 activeprinciple.

• Epoetin (acute) reached a market share of 60% and 30% the first year, after the launch of theproduct, 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 biosimilarentrance

Nºcompet.

2007 1

2006 1

2007 1

2007 1

2007 1

First biosimilarentrance

Nºcompet.

2009 1

2007 3

2009 2

2009 1

2009 2

First biosimilarentrance

Nºcompet.

2009 5

2008 3

2009 4

2009 4

2008 6

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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 AVERAGEEU

GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF) MS (%) Biosimilar vsReference ProductGRANULOCYTE 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 AVERAGEEU

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 AVERAGEEU

ANTI-TUMOR NECROSIS FACTOR (Anti-TNF) MS (%) Biosimilar vs Reference Product

ANTI-TUMOR NECROSIS FACTOR (Anti-TNF) Biosimilar Price Reduction (%) vs ReferenceProduct

AcuteDiseases

ChronicDiseases

High potentialmarket.

Limited potentialmarket as chronicdiseases have higherresistance tochanging 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 AVERAGEEU

HUMAN GROWTH HORMONE (HGH) MS (%) Biosimilar vs Reference Product

HUMAN GROWTH HORMONE (HGH) Biosimilar Price Reduction (%) vs ReferenceProduct

Source: QuintilesIMS, June 2016Note: units (U) are related to pre-filled syringesSomatropin, Epoetin, Filgrastim and Infliximab are hospital biosimilars.

Page 10: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

1.8

93

1.7

03

1.6

99

1.7

19

1.6

36

-10,1%

-0,2%1,2%

-4,8%

-12%

-10%

-8%

-6%

-4%

-2%

0%

2%

2012 2013 2014 2015 20160

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, with612*Mn units (2015 figure).

• The Enoxaparin worldwide market decreased -3.6%(CAGR 2012-2016) in terms of value. Eliminating theeffect of exchange rate fluctuations, the Enoxaparinworldwide market decreased by 1.7% in 2016.

• Europe is the biggest market with a market share (invalue) 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, 2015Note: 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 impactof exchange rate fluctuations when calculating sale annual variations.

Page 11: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

ROVI in the Enoxaparin market

Page 12: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

• ROVI has competitive advantages within the LMWHs market:

Heparin has been the main focus of the company since its foundation: deep knowledge ofLMWH 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.

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ROVI’s competitive advantages

Page 13: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In

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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 Gulfcountries.

• €17.2Mn invested in the last 3 years to increase capacity in the plants.

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• Limited initial capacity subject to regulatory variations for thefirst 18/20 months.

• Potential additional investments in the future to increasecapacity.

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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 ineach country) already signed to commercialize the product in 26 countries (outside EU and USA).

Direct presence in somecountries

Partnership with domesticand/or international players

ROVI will have its own salesforce in some countries.

Decision of countries whereROVI would have directpresence yet to be taken.

Distribution throughdomestic and/or internationalplayers.

Potential agreements basedon up-front fees, royalties andmilestones.

ROVI

Potential European Markets

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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.

Page 16: Enoxaparin Biosimilar Presentation Enoxaparin: the market • Enoxaparin was launched by Sanofi-Aventis and marketed under the trade names of Lovenox (USA) and Clexane (Europe). In