A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an...

31
Rovi A Specialty Pharma Growth Story

Transcript of A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an...

Page 1: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

RoviA Specialty Pharma Growth Story

Page 2: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

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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 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 of 1988 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 affirmations or review the future projections, even if new data is published or new facts arise.

Page 3: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Overview

Page 4: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

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Multiple Pillars of Growth

Ex

ce

pti

on

al G

row

th D

rive

rsHighly attractive risk / reward profile

Differentiated specialty product portfolio

Partner of choice in Spain

Novel extended release injectable delivery technology with transformational potential

World class pre-filled syringe and oral compounds toll manufacturing services

Fully invested infrastructure delivering strong operational leverage

Strong flagship product Bemiparin and unique expertise in LMWH

Accelerating internationalization of Bemiparin

Fully integrated, profitable Spanish specialty pharmaceutical company

Leading Spanish

Specialty

Pharma Company

2013 Revenue: €157 Mn

’04-’13 CAGR: 18%

World Class

Pre-filled Syringe

and Oral Forms

Toll Manufacturing

2013 Revenue: €60 Mn

’04-’13 CAGR: 18%

Robust

Research and

Development

and Broad Pipeline

2013 Operating revenues: €218Mn

‘04-’13 CAGR: 15%

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Diversified Specialty Pharmaceutical Business

• 30 principal marketed products across 7 core franchises

– not impacted by Spanish reference pricing regime

– long patent protection portfolio

• 20 new products since October 2005

• Highly skilled and efficiently targeted > 250 person sales force

Focused on Most Attractive Areas of the Spanish

Pharmaceutical Market

Cardiovascular

Osteoarticular

Franchise Focused Business

Anaesthesia /

Pain Relief

Central Nervous System

Primary CareRespiratory

Contrast Imaging

Page 6: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

19,8

23,5

25,6

29,3

31,2

31,1

35,4

36,6 43,8

31,4

34,4

0,0

10,0

20,0

30,0

40,0

50,0

2005 2006 2007 2008 2009 2010 2011 2012 2013 9M 2013

9M 2014

(€Mn)

5

Hibor: Differentiated 2nd Generation LMWH

• Internally developed flagship product

• No. 2 market position in the ~€186Mn Spanish

market with ~26% market share

• The only 2nd generation LMWH

– clinically differentiated

– applicable in a wider therapeutic window

• Sales in Spain of €43.8 Mn in 2013

• Patent protected until 2019

• Potential growth opportunity following Lovenox

Hibor Highlights Hibor Sales

Growing US $3.4 Bn Global LMWH market

Differentiated Product

Mean molecular weight (in Daltons) Anti-Xa: Anti-IIa Ratio Half-life (in hours)

Source: Expert Opin. Pharmacotherapy (2003); 4: 1551-61

RangeRange

CAGR +10%+9%

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5,7

4,7

8,7 9,8 12,8

15,1 19,1 22,9

17,6

18,6

0,0

4,0

8,0

12,0

16,0

20,0

24,0

2006 2007 2008 2009 2010 2011 2012 2013 9M 2013

9M 2014

(€Mn)

6

Bemiparin International presence

Highly efficient international strategy of partnering with leading local players

Rovi Group

52 countries with

products launched

through strategic

alliances

59 countries with

approved registration

14 countries with

registration pending

15 countries with

registration on-hold

Established International Network

+22%+6%

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Partner of Choice in Spain: Leading Specialty Sales

Force>250 member leading sales force: 11 products in-licensed in last 9 years and active

pipeline of attractive new opportunities.

4 new in-license products to be launch until March 2020 under the MSD agreement.

Key In-licensing Partners

2002 2003 2005 20072004Before 2002 2006

Strontium Ranelate

Ivabradine

Lidocaine

+ Prilocaine

Gadoteridol

Iomeprol

Iopamidol

Sulfur hexafluoride

Gadobenate

dimeglumine

2008 2010 20112009 2012 2013

MEDICE

2014

Page 9: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Product portfolio enhanced during 2013

8

In 2013, ROVI reinforced its product portfolio both through buying new products and signing new license

agreements.

In June 2013, ROVI exercised the Purchase Option held over Rhodogil in Spain, which was owned by

Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is

directly marketed by ROVI in Spain.

In November 2013, ROVI signed two important in-license agreements:

Agreement with Novartis for co-marketing Hirobriz Breezehaler (indacaterol maleate) and Ulunar Breezhaler

(indacaterol + glycopyrronium), being both products inhaled bronchodilators for patients with COPD. The

combination of indacaterol and glycopyrronium delivered through the Breezhaler® device is the first once-daily

dual bronchodilator (LABA-LAMA) for the maintenance treatment of COPD to be approved both in Europe

and in Japan, and will marketed by ROVI in the last quarter of 2014.

Agreement with MEDICE to market in Spain, on exclusivity basis, both Medicebran and Medikinet,

pychostimulant drugs aimed for the treatment of ADHD in children and teenagers. These products are already

marketed in Spain with annual sales c. €9Mn and a 20% market share.

These operations will significantly contribute to revenue growth.

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Pre-filled Syringe Toll Manufacturing: High Value

Added Business Model

• Differentiated capabilities

– Highly flexible and

responsive to our

customers’ needs

– Annual capacity of

180 Mn pre-filled syringe

units

– Can deliver pre-filled

syringes in 4 weeks

• GMP, FDA approved for

filling syringes that are

prefilled with Water for

Injection.

• Highly profitable contracts

• Limited competition and

significant barriers to entry

Strong Revenue VisibilityA Global Leader in Pre-filled

Syringes

“Customer-for-life”

Business Model

• Numerous late stage

conversations with

multinationals

• Revenues: +15%

CAGR 2010-2013.

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• Long tradition of formulation

excellence in pharmaceutical

products

• GMP, FDA approved for

formulation and packaging of

solid compounds

• Exports to more than 40

countries

• State of the art technology –

Roller compaction

• Manufacturing capabilities of

3 billion of tablets and 100

million of boxes

Strong Revenue VisibilityFrosst Ibérica Customers

• Formulation and packaging

activities for Maxalt and

Maxalt-MLT until March 2020

• Packaging activities until

March 2017 for products sold

in Spain and March 2015 for

products sold abroad

• In conversations with

potential new customers

Oral Compounds Toll Manufacturing: High Value

Added Business Model

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A Productive R&D Engine with a Higher Probability

of SuccessFull spectrum of in-house R&D capabilities with a market-driven approach focusing

on chronic diseases with large, unmet medical needs

Efficient R&D Model

• ~5% of sales dedicated to R&D

• Broad pipeline

• Focused on approved compounds

with proven safety and efficacy

• Pursuing new indications and

product enhancements

• Smaller clinical trials expected

• R&D effort enhanced through

extensive partnerships

• Strong IP protection of product

portfolioGlycomics area

Innovative ISM

technology

“in-situ

microparticles”

Page 13: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Spanish pharmaceutical market

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Historical market crisis

Pharmaceutical expenditure growth rate

• In the last four years (2010-2013), pharmaceutical

expenditure decreased by 27%.

• 19% of reduction in the monthly pharmaceutical

expenditure since the introduction of the

copayment (July 2012) to December 2013.

• ROVI’s prescription products sales increased by

50% in 2010-2013, beating the market by 77pp.

• Slight rise of 1% and 2% reduction in pharma

expenditure expected1 for ‘14 and ‘15 respectively.

(*) Source: Farmaindustria (Spanish Pharmaceutical Association)1 http://www.farmaindustria.es/web/indicadores/mercado-farmaceutico/

2010 Var. 2011 Var. 2012 Var. 2013 Var.

Pharmaceutical

expenditure €12.2Bn -2.4% €11.1Bn -8.7% €9.8Bn -12.2% €9.2Bn -6.0%

Registered

prescriptions 957.1Mn 2.5% 973.3Mn 1.7% 913.7Mn -6.1% 859.6Mn -5.9%

Average

expenditure per

prescription €12.7 -4.8% €11.4 -10.3% €10.7 -6.5% €10.7 -0.1%

Pharmaceutical expenditure vs ROVI sales growth (%)

-2,4%

-8,7%

-12,2%

-6,0%

3,9%

14,6%

10,2%

14,3%

-15,0%

-10,0%

-5,0%

0,0%

5,0%

10,0%

15,0%

2010 2011 2012 2013

Pharmaceutical expenditure ROVI's prescription product sales

7,5%

7,9%

9,9%

12,2%

6,4%5,6% 5,8%

5,3%

6,9%

4,5%

-2,4%

-8,7%

-12,2%

-6,0%

0,9%

-1,9%

-15%

-10%

-5%

0%

5%

10%

15%

00 01 02 03 04 05 06 07 08 09 10 11 12 13 14E 15E

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Reduction of pharmaceutical spending in SpainMarch 2010 May 2010 March 2011 August 2011 Dec . 2011 April 2012 March 2014

Reform of

the Reference

Price System

(RPS). The

reference price

calculated

taking the

lowest price in

the market.

Mandatory

discount of 7.5% on

the sales of

medicines excluded

from the reference

prices system.

Reference

prices

update.

Prescription

per active

principle, except

for drugs

belonging to a

group of a drug

and its licenses at

the same price.

Reference

prices

update.

Co-payment on

medicines based

on income levels.

A max of €8 or

€18/month is set for

pensioners. Active

workers will rise to

50-60%.

Incorporation

to the RPS of

medicines

authorized for

>10 years,

without generic,

as long as there

is another

medicine with the

same AP.

Reduction

of the

generics

prices on an

average

amount of 25%

with a

maximum limit

of 30%.

Adaptation of the

number of units of

the medicines

packages to the

standardized

duration of the

treatments.

Discount of

15% on the

medicines

without generic,

except if a patent

proof approved in

all the EU

countries is

presented.

Packaging

adapted to

treatment

duration.

Encouragement

of generics use.

Exclusion of

some drugs from

reimbursement.

Reference

prices update.

Reduction of

the reference

price to the

lowest in any EU

country.

Specific

regulation on

discounts

applied by

distributors to

pharmacies

(10% generics

& 5% patented

products)

Elimination of

the gradualness

to reduce prices

for drugs

affected by the

Reference Price

System.

Single health

card and health

service portfolio.

Restriction of

health tourism.

Joint purchasing

centre.

Savings €1,500m €1,300m €1,033m €2,400m €650m €7,000m €580m

When? July 2010 June 2010 Mar 2011 Nov 2011 Apr 2012 July 2012 Sept 2014

Impact

for ROVI Minimal

€3.5m on ‘10 sales

and €8m on ‘11 sales Minimal < €1.0m Minimal

Growth to be

slowed downMinimal

Page 16: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Business growth strategy

Page 17: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

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Our main strategic pillars to lead growth

Specialty pharma

• Bemiparin

• Recent launches such as

Vytorin, Absorcol and

Medikinet

• Existing portfolio (Corlentor,

contrast imaging agents…)

• New in-licensed products to

be launched (Hirobriz, Ulunar)

• 4 additional MSD products

Toll manufacturing

• Spare capacity both in the

injectable plant and in the oral

compounds plant

• New customers to be acquired in

both plants

R&D

• ISM Platform

Risperidone

Paliperidone

Letrozole

• Glycomics

Page 18: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Focus on Drug Release Platform & Glycomics

17

Platform Product Potential indication Current situation

Pre-

ClínicalI II III

Expected milestones

• Phase I results disclosed

• Phase II ongoing

• Phase III starts 2H 2015

Glycomics

ISM

Risperidone,

monthlySchizophrenia

Letrozole,

quarterlyBreast Cancer

Paliperidone,

monthlySchizophrenia

ISM: in situ microparticles; LMWH: low molecular weight heparin;

* Currently looking for a strategic partner to go on further clinical development

Phase I starts 2H 2015

Phase II results

publishedBemiparin (LMWH) Small Cell Lung Cancer (*)

Phase I starts 1H 2015

Page 19: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

ISM®: innovative technology for the prolonged

release of substances

Administration technology

• Separated syringes containing:

– The drug and polymer (solid state)

– The solvent (liquid state)

Reconstitution

Combination of syringes

Carrier strengthening

Drug released in body fluids

Epidermis

Dermis

Subcutaneous

cell tissue

Muscular

The ISM technology aims to combine the advantages of micro-particles and pre-formed implants

18

Page 20: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Risperidone ISM®. First Phase I study (“proof of

concept”)

• Phase I, open label, single dose escalation, single centre, on 17 healthy volunteers

• “Proof of concept”: kinetics, safety, and tolerability

• Results disclosed in July 2011

19

25 mg

25 mg

37.5 mg

37.5 mg

7 vol.

2 vol.

6 vol.

2 vol. •Pharmacokinetic

•Safety

•Tolerability

ClinicalTrials.gov # NCT 01320410

Page 21: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

9M 2014 Results

Page 22: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

9M 2014 financial results - Highlights

21

Operating revenue increased by 8% to €173.3Mn, mainly driven by the strength of the prescription-based

pharmaceutical business, where sales rose 9%, clearly outperforming the market, and by the toll manufacturing

business which grew by 6%. Total revenue increased by 8% to 175.5 million euros in the nine-month period ended

30 September 2014.

For 2015, ROVI expects a mid-to-high single digit growth rate for the operating revenue.

Outstanding performance of Bemiparin: +8% growth to €53.0Mn, representing 31% of total operating revenue.

Excellent performance of Absorcol & Vytorin: sales increase of 19%.

Excellent performance of Corlentor: sales increase of 19%.

Sales of Medicebran and Medikinet, both products launched in December 2013 and marketed on exclusivity basis

by ROVI in Spain, reached €5.1Mn.

EBITDA increased by 14% to €28.9Mn, reflecting a 0.9pp EBITDA margin rise vs 9M 2013.

Net profit (€19.9Mn) growth of 6%.

In July, ROVI paid a gross dividend of €0.1612/share on 2013 earnings, +18% vs last dividend.

Page 23: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

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Growth driven by the specialty pharmaceutical

business strength…

Total operating revenue (€Mn) Operating revenue growth by category (€Mn)

Operating revenue increased by 8% in 9M 2014, up to €173.3Mn, driven by the strength of:

the specialty pharmaceutical business, where sales rose 9%; and

the toll manufacturing business, where sales increased by 6%.

ROVI forecasts to continue growing despite the difficult situation that the Spanish pharmaceutical industry is going through:

1% rise expected by Farmaindustria1 for 2014;

2% reduction expected by Farmaindustria1 for 2015; and

continued decreases in the pharmacy retail market at least until 2017 according to IMS Health2.

+6%

+9%

+8%

1 http://www.farmaindustria.es/web/indicadores/mercado-farmaceutico/2 http://www.farmaindustria.es/web/documentos/boletines (boletín nº 108, April 2014)

+8%

160,9

173,3

100

120

140

160

180

9M 2013 9M 2014

115,0124,9

45,648,2

0,3

0,2

0

20

40

60

80

100

120

140

160

180

9M 2013 9M 2014

Specialty pharma Toll manufacturing Royalties

160,9

173,3

Page 24: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

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Gross margin impacted by the increase of customers being

invoiced for materials in the injectables plant

Gross profit (€Mn) & Gross margin (%)

Gross margin decreased by 1.4 pp in 9M 2014 vs

9M 2013 mainly due to:

the increase in volumes manufactured for

clients being invoiced for materials in the

injectables plant, contributing with lower

margins.

The decrease of the Bemiparin raw material

cost impacted positively in 9M 2014 gross

margin.

Gross profit increased by 5% to €105.7Mn in 9M

2014.

+5%100,3

105,7

62,3% 61,0%

50

60

70

80

90

100

110

0%

10%

20%

30%

40%

50%

60%

70%

9M 2013 9M 2014

Gross profit Gross margin

Page 25: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

24

EBITDA & EBIT

EBITDA (€Mn) and EBITDA margin (%) EBIT (€Mn) and EBIT margin (%)

EBITDA increased by 14% to €28.9Mn in 9M 2014, reflecting a 0.9 pp rise in the EBITDA margin to 16.7% in

9M 2014 up from 15.8% in 9M 2013. This increase has been achieved on higher sales and operating leverage of

the business.

Depreciation and amortization expenses increased by 31% in 9M 2014, up to €6.5Mn, as a result of the new

PP&E and intangible assets purchases made during the last twelve months.

EBIT increased by 10% to €22.4Mn in 9M 2014, reflecting a 0.2 pp rise in the EBIT margin to 12.9% up from

12.7% in 9M 2013.

+10%+14%

25,428,9

15,8%16,7%

0

5

10

15

20

25

30

0%

3%

6%

9%

12%

15%

18%

9M 2013 9M 2014

EBITDA EBITDA margin

20,522,4

12,7%

12,9%

10

12

14

16

18

20

22

24

0%

4%

8%

12%

16%

9M 2013 9M 2014

EBIT EBIT margin

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25

Net profit

Net profit (€Mn)

Net profit increased by 6% to €19.9Mn in 9M 2014.

Effective tax rate of 5.2% in 9M 2014 vs 4.1% in 9M 2013. This

favourable effective tax rate is due to:

deduction of existing R&D expenses; and

capitalisation of existing negative tax bases from Frosst

Ibérica.

As of December 2013, Frosst Ibérica had €57.5Mn of negative tax

bases, of which €7.4Mn were used in the 2013 income tax and

€6.2Mn to be used in 9M 2014.

On 20 June 2014, the Spanish Government announced a deep tax

reform, to be introduced from January 2015.

These suggested tax measures would positively affect ROVI

income statement and income tax payable rate. ROVI expects to

maintain an effective tax rate from mid to high single digit for the

following years.

The tax reform content is still pending to be approved. Among the

suggested tax measures that would affect corporate income tax, it

should be noted that:

the tax rate is reduced from 30% to 28% in 2015 and to 25%

from 2016;

tax losses may offset positive taxable income faster and

without time limit from 2016; and

R&D tax credit schedule is maintained.

18,719,9

10

12

14

16

18

20

9M 2013 9M 2014

+6%

Page 27: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

Debt with public administration represented 44% of total debt, with 0% interest rate.

New banking debt of €20Mn, of which €12Mn came from European Investment bank funds (through banking

institutions) with very good conditions.

despite the new banking debt (€20Mn) obtained in 9M 2014, total debt increased only by €6.3Mn as of 30

September 2014 compared to total debt as of 31 December 2013.

Gross cash position of €36.1Mn as of 30 September 2014 vs €36.7Mn as of 31 December 2013.

Net cash position of -€1.2Mn as of 30 September 2014 vs €5.8Mn as of 31 December 2013 mainly as a result of a

6.3 million euros total debt increase.

On July 3, ROVI paid a dividend of €0.1612 per share on 2013 earnings. This dividend meant an increase of 18%

compared to the dividend on 2012 earnings.

26

Financial debt

Debt breakdown by source (%)

€37.3 million

Debt maturities by year (€Mn)

1,1

3,6

7,2

9,5

15,9

0

3

6

9

12

15

2014 2015 2016 2017 2018 & beyond

Page 28: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

27

Guidance 2014 and 2015

Specialty pharma

• Bemiparin

• Recent launches such as

Vytorin, Absorcol, Medikinet…

• Existing portfolio (Corlentor,

contrast imaging agents…)

• New in-licensed products to be

launched (Hirobriz and Ulunar)

Toll manufacturing

• Spare capacity both in the

injectable plant and in the oral

compounds plant

• New customers to be acquired

in both plants

Our main strategic pillars to lead growth

Operating revenue

2013

€217.6Mn

Operating revenue

2014

mid single digit –

high single digit

Operating revenue

2015

mid single digit –

high single digit

Page 29: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

28

News-flow 2014/2015

Additional new in-licensing products to be launchedSpecialty pharma

New contracts to be announcedToll manufacturing

Results of ISM-Risperidone® Phase I to be released in Q4 2014

Results of ISM-Risperidone® Phase II to be released in Q3 2015

Start of ISM-Risperidone ® Phase III

R&D

Page 30: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by

29

Multiple Pillars of Growth

Specialty Pharma

• Specialty focus

• Bemiparin, Ulunar,

Vytorin, Absorcol,

• Corlentor, Hirobriz,

Medikinet ...

• Partner of choice

• Internationalisation

• MSD marketing

agreement

• New secured products

Toll Manufacturing

• Fast growing market

• Unique capabilities

• Trusted partner

• Targeting diluents

• FDA approval

• MSD manufacturing

and packaging

agreement

• Novel extended

release injectable

technology (ISM)

• Risperidone

• Paliperidone

• Letrozole

• Glycomics

• Bemiparin in

Small Cell Lung

Cancer

Research &

Development

• Long patent life

• Not affected by

reference pricing

• Customer for life

• Strong revenue visibility

• High barriers to entry

• Proven compounds

• Efficient approach

• Market-driven strategy

High

Growth

Low

Risk

Page 31: A Specialty Pharma Growth Story - Jefferies · Sanofi. Under the new agreement, Rhodogil (an antibacterial drug used against infections of the oral cavity) is directly marketed by