PO executive summary 2015-2016 260115

O PRIENTATION LAN 2016 / 2017

Central America and the Caribbean

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Executive Summary of the Marketing Orientation Plan

ENVIRONMENT ANALYSIS

Composed by 9 countries, the SCAC zone is compounding 75 million inhabitants, in a globally growing economic
environment, even though the growth is slowing down.
Most of the countries are democratics, politically stable in a growing (2/7%) region of developing countries taking
advantage of the US growth. Many of the region’s countries receive income from the US immigrants sending part of their
salary to their families.
The burden of Cardiovascular Disease is important with all countries slightly above the world average in diabetes and
hypertension (WHO data). The diabetes market is growing by 13% and the Hypertension market by 6% (USD, IMS 1015)

Country Pop. (ku) GDP/Unhab Inflation Growth
15
(USD) 15

Guatemala 15480 5300 4.3 3.5

Honduras 8098 4700 5.5 3.1

El Salvador 6230 7600 2 1.7

Nicaragua 6127 4500 7 4

Costa Rica 4771 12800 4.7 4.1

Panama 3771 15900 3.3 6.9

Rep Dominicana 10415 9800 4.3 4.1

Source Coface

PHARMA MARKET : 2 markets for 2 opportunities

The drugs market is split in 2 independent markets,
1. The PRIVATE MARKET (+/- 65% of the sales), based on non-reimbursed drugs sold in pharmacies. It is highly

sensitive to prices.
 The whole private market sold 2.1 billion dollars in 2015, driven by a generic growth of 7%.
 The investigation drugs represent an 851 million USD market, growing by 1 % in dollars and dropping in

units.

Page 2

Orientation Plan 2016/2017 Country: Central America and the Caribbean

MS USD QTR growth IE  IMS only evaluate the private market which represents 20
vs n-1 %

Total market 100.00 8 100 to 100% of the sales of each laboratory, depending on the
MERCK
4.77 12 103 level of public sales.
SANOFI-AVENTIS  Servier is the 25st laboratory of the market, and the 13st
MENARINI 4.58 2 95

4.69 19 110

PFIZER 4.33 1 94 among the investigation companies.
 Its growth is the second out of the investigation
ROEMMERS 4.20 4 96

NOVARTIS PHARMA 3.89 -4 89

ASTRAZENECA 3.39 6 98 companies.
UNIPHARM-PHARMANOV 3.18 15 106  DAFLON 500 is the # 11 product in the total market,
3.05 0 92
MSD

BAYER HEALTHCARE P 3.15 11 102 despite a very low coverage at GP level.
ASOFARMA 3.00 24 115  Local brand generic companies from Argentina
2.45 -8 85
BOEHRINGER ING

GLAXOSMITHKLINE 2.28 -2 91 (Rowe), Mexico (AsoFarma) and Guatemala (Unipharm)
are growing and leading a fast moving brand generic
ROWE 2.15 6 98

ABBOTT 1.76 6 98

MK 1.68 7 99 market open to biosimilars.
EXELTIS 1.80 27 117
ROCHE 1.50 -8 85  Menarini is the second laboratory out of the investigation

STEIN 1.40 9 101 companies thanks to an aggressive strategy of licences.
JANSSEN 1.29 -9 84 Enanthyum is the market leader in Value and its cardio
CALOX 1.27 9 101

GUTIS 1.32 29 119 franchise is leader in Market Share and growth thanks to
LILLY 1.09 8 100 a complete portfolio (ACEi, BB, ARBs, CCBs, Ranexa..)
GENFAR 1.00 11 103

SERVIER 1.05 8 100 and aggressive commercial strategy.
VIJOSA 0.98 -2 90

LANCASCO 0.91 13 104

GRUNENTHAL 0.82 -2 91

GRUPO FERRER 0.87 14 106

2. The INSTITUTIONAL MARKET, in which drugs are provided for free to the population covered by the social security:

it is an important market but is highly instable due to the tenders system and political stability and constraints.

Despite a globally positive trend in the private market, the pharma companies recently suffered 2 major events impacting

the market in 2 of our main priorities:

- The new Panamanian government impacted dramatically the length to file new drugs (from 12 to 18+

month to file a product), and slowed down the institutional market.

- A corruption crisis in Guatemala led to a blockage of the most important public market in the zone, leading to

a drop of -54% of public health spending’s since 2015 (from 320 MUSD to 147 MUSD for drugs and devices)

3. INVESTIGATION MARKET POTENTIAL PER THERAPEUTIC AREAS AND COUNTRIES

 HT market is the most important
market for Servier and is balanced in
our top 5 countries

 Costa Rica is the main country for
Valdoxan (50%+ of the market)

 Diabetes is the second market for
Servier, even though led by
metformin and DDP4i dynamism

 It is necessary to fine tune strategies
to country potential

Page 3

Orientation Plan 2016/2017 Country: Central America and the Caribbean

SCAC ANALISIS – SALES, TARGETING, PROMOTION STRATEGY

Servier Centroamerica y Caribe (SCAyC) closed the 2014/15 exercice with a T.O. of 22.500 kUSD, -3% vs y-1, and +4%

vs budget.

The breakdown private/institutional was:

 15.550 kUSD private, 68% of the total, +10.5% vs n-1, leading to an uplift of 1,5 MUSD.
 6.950 kUSD institutional, 32% of the total, represent a loss of 24% of the sales, due to the public spending cut-

offs.

Private sales MOSAIC 0915

Products Mat 0915 % of sales evol vs Uplift Ac 3 of the 4 priority product grew by more than
n-1 % 10% (Daf/Proco/CVM/Vastarel)
DAFLON 6,221,634 40% 19% 1,005,882 Vastarel dropped due to low SOV and
VASTAREL 2,579,272 17% -5% -144,874 vacancies
1,562,469 10% 41% 455,584
NATRILIX 1,188,926 8% 87,854 HT Franchise growing by 19%, to support
DIAMICRON 854,420 6% 8% 100,399 Triplixam and Natrixam launch
PROCORALAN 803,444 5% 13% -21,592
COVERSYL 604,019 4% -3% 80,210 Private sales +10.5% in a steady (+1%)
COVERAM 570,437 4% 15% 44,527 investigating market
PRETERAX 416,794 3% 8% -124,303
PROTELOS 404,518 3% -23% -71,620
VALDOXAN 204,198 1% -15% 37,976
ARCALION 1% 23%
STABLON 82,346 0% -5% -4,570
NATRIXAM 8,364 23% 8,364
3548733 14056734 19% 567093
HT 15511705 10% 1454969
TOTAL

1. PRIVATE SALES Private Sales per country Mosaic USD dic

Servier Market Share / Market Size per country (IMS oct 15)
2015

 The Costa Rica and Panama market are the most profitable due to the local level of revenue per unhabitant.
Costa Rica is the most important market, with the lower rate of generics. It is the number 1 priority.

 Guatemala and Honduras are also priorities due to the size of their market, and therefore their potential for
growth.

Page 4

Orientation Plan 2016/2017 Country: Central America and the Caribbean

IMS sales trend (quarter data nov 15)

IMS USD 1115 Part of total Q4 growth BALANCE of the 4 PRIORITY PRODUTCS
s a l es  Daflon 500 remains a key driver for the growth.
7
SERVIER 100 14  Through a strong investment and a co-promotion, Vastarel MR is
1
DAFLON 39 -7 slowly recovering, with a switch to a positive growth.
3  Procoralan and Coveram are reinforcing their growing trend.
VASTAREL MR SVR 17 41
27 To reach the expected growth of 18%, SCAC will have to:
NATRILIX 8 50 1. maintain a double digit growth for priority products,
7 2. succeed in Natrixam and Triplixam launch and
DIAMICRON-MR SVR 9 -48 3. preserve a positive trend for mature product
-22
PROCORALAN SVR 7 -11
new
COVERSYL 5

COVERAM 5

PRETERAX 3

PROTELOS 3

VALDOXAN SVR 2

BIPRETERAX SVR 0

NATRIXAM 0

2. INSTITUTIONAL SALES
Sales Breakdown(USD)Mosaic PUBLIC Sales MAT dic 2015

- Guatemala remains the major provider a
public sales, but is decreasing due to the
drop in public spending’s (-50%).
Furthermore, new generic entries and
new political orientation seem to lead to
changes in the public system purchases.
There is thus a question mark on the
future’s sales trend in Guatemala. SCAC
is focused to take advantage of the
opportunities that those changes will
provide.

- Panama is a strong contributor to region’s public sales. Diamicron and Coversyl are available for
Panamanian patients, and Procoralan is now available in cardiology services. Nevertheless, a
corrupted purchasing environment makes the futures sales uncertain.

- Honduras, El Salvador and Nicaragua are opportunity markets for Diamicron, Preterax, Coversyl and
Procoralan.

- Costa Rica is the region’s #2 market, but is focused to low price products, generics and needs to be
investigated to develop future sales.

 The institutional sales are supported since Jan. 16 by a trade manager and 2 institutional sales
reps

Page 5

Orientation Plan 2016/2017 Country: Central America and the Caribbean

3. TARGETING

Due to the recent creation of the SCAC subsidiary, the team size is still reduced (51 med reps vs 250+ Menarini) and
doesn’t allow a complete coverage of the high potential doctors among GP and Internists population, needed for Daflon
and HT Franchise (62% of private sales).
The sales force’s size remained unchanged during the last 3 years despite the 28% total sales growth.
Servier is currently visiting 22% of the GPs targeted by the pharma companies in the zone (Censomed IMS 2015), and 2
% of the total registered GP’s.

Cardio Censomed Seen % of IMS
Internists AMC Servier universe
Surgeon
Endo 449 374 seen
Gastro 1275 575 83%
Geriat. 585 193 45%
Nephro 160 104 33%
Neuro 779 37 65%
Psyc h. 43 5%
GPs 69 44 62%
Total 71 39 62%
202 286 19%
420 906 68%
4171 2623 22%
10831 24%

For Daflon 500 and HT drugs, an increase of the number of GPs visited would allow to:
- Follow focusing to specialists with a high frequency
- Take advantage of GP’s potential and increase our base of high potential doctors.

Here below, this example of Daflon 500 shows that there is a huge room for growth for Daflon among the GPs. Daflon is
already the #11 product in the market despite its reduced target of 1000 GPs.

Page 6

Orientation Plan 2016/2017 Country: Central America and the Caribbean

4. PORTFOLIO BREAKDOWN AND MANAGEMENT

Servier Private Sales breakdown for 2015/16 (USD, Sylogic sales)

4 majors franchise are clearly defined among the SCAC portfolio :
o HT with Natrixam and Triplixam launches in YO, Viacoram as a starting dose of Coveram
o Daflon Franchise: with the future developments of Daflon 1000, pharmacy strategy and possible cream
o Angina/HF Franchise: Procoralan reaches the 4th rank in sales in the last 3 months, and Vastarel
remains the #2 product of Servier sales
o Oncology/specialized Franchise: to build to prepare the arrival of Lonsurf/Pixuvri, and the launch of
ITCA 650

The management of those launches in a synergistic way is a key for growth, with 2 drivers of promotion

 DAFLON AND HT FRANCHISE FOLLOW A PRIMARY CARE MODEL: specialists + high potential GPs are key
for growth. The number of prescribers is mandatory to increase units. Thus a GP target increase would support
Daflon 500 and HT products’ growth.

 CAD/HF AND ONCOLOGY FRANCHISE ARE SPECIALISTS FRANCHISES:
o They rely on the market access strategy to trigger products’ use, social security sales and focus to
specialists able to prescribe premium price products
o This is synergistic with the public sales development, focused on buyers and added value offer for
national health systems

Page 7

Orientation Plan 2016/2017 Country: Central America and the Caribbean

5. SALES FORCE TEAMS and PROMOTION

The team is currently dedicated to the 4 priorities defined for SCAC growth in 2015/16.

- PROCORALAN, with a dedicated team focused to cardiologists and high potential internists

- DAFLON 500: 1 st product of the subsidiary, with a target composed of vascular surgeons, internists,
proctologists, GPs and an increase panel of gastrologists. The Agua is also working a specific team of
psychiatrists.

- COVERAM/TRIPLIXAM: the Tierra team is dedicated to visit prescribers in HT (cardios, endos, internists, GPS)

- VASTAREL MR: 2nd product of SCAC, visiting a mix of cardios, internists, GPs and endocrinologists

Page 8

Orientation Plan 2016/2017 Country: Central America and the Caribbean

BALANCE 2014/15 MARKETING STRATEGY AND INVESTMENTS

Key achievements:

 Development of messages and marketing tools dedicated to adapt the medical call the doctors’s needs
and patient profile they most see in their consultation room. Eg: patient profile leaflets, detailing scheme,
specific patient profiles in slide sets and RTM

 A specific campaign’ follow up was set up to ensure understanding, application and regular recall of key
messages , through:

o Webinars follow up, Weekly conf calls, mid –cycle meeting focused to message adjustments and
recall

o Dual call by product managers to follow up the message implementation (2 per month minimum)

 Notoriety actions for all specialties:

o 6 MPIS in cardiology, for HT products, Vastarel MR and Procoralan, 1 MPI for Daflon
o Advisory boards for all products
o 4 Focus group and working groups to prepare launches
o Development of advocates for HT drugs and Vastarel MR
o Rectum model training for residents and surgeons
o Vein act program launched at specialists level

Improving areas:

 Fine tune targeting: the recent purchase of IMS blue book data offers opportunities to improve strategy
definition, target selection, RTM and congresses participant selection and call efficiency

o A specific need for GP target increase was identified for Daflon 500 and HT drugs

 Involve sales team in marketing strategies and tactics: interaction between marketing and sales
needs to be improved by defining specific working sessions to collect feedback and proposals in order to
implement effective and adapted marketing tools and messages.

o A specific action plan defined during interactive sessions needs to be implemented

 Adapt the team to future challenges: The promotion structure is still not adapted to hospital work and
oncology launches. The team has to improve its specialized marketing skills (hospitals protocols, market
access, patient flow follow up and utilization), to face the launches of oncology products and ITCA, and
improve the Procoralan use at hospital level.

Page 9

Orientation Plan 2016/2017 Country: Central America and the Caribbean

SWOT

Strengths Weaknesses

New sales manager focused to ROI and call improvment Lack of promotion manager leading to weak review of
marketing campaigns and actions
Management
Improving follow up at all level (spendings, message, events High turn over among sales force (36% in y-1)
Products and follow up)
sales
Double digit growth in private market thanks to priority Protelos downlift impacting SCAC growth
Promotion product growth

Launch of Natrixam and Triplixam: unique proposals in HT Drop of public market slows the investment for private
market market - Need of action plan

Notoriety actions for all priority products Weak involvement of sales force in marketing action plan
preparation

Messages focused to patient profile leading to better efficacy Lack of precision in target definition for message and actions
of the call

Increased number of marketing tools allowing increased Knowledge of potential per specialist needs to be improved
frequency for highpo DRs

Opportunities Threats

Markets Most of the Servier's markets are growing (CVD, HD, HT) Generics growing by 8% and representing 61% of the market,
Tenders and investigation brands steady (0%)
Oportunity to developp pharmacy strategies for Daflon Very high SOV of direct competitors in cardio market:
Oncology market is can be exploted either at public and Menarini, Sanofi and Novartis are the 3 first players of the
private level Centroamerican market
Patient pool using ARBs: patient sourcing for Servier combo
and Triplixam

Procoralan for SS in Panama. Development of El Salvador and Political instability leading to unpredictable tender delivery,
Honduras sales. corrupted health system
Defense of Daflon sales in Guatemala.

Page 10

Orientation Plan 2016/2017 Country: Central America and the Caribbean

KEY FACT

Even though notoriety actions and marketing campaigns focused to specific patient profiles resulted in a double digit
growth, there is a clear room to grow by focusing better the resource allocation through a revised targeting and a

messaging oriented to identified patients.

STRATEGIC GOAL

SCAC needs to fine tune its targeting and adapt its action plan to the market opportunities:
- A strong and dynamic hypertension and CAD market

- A CVD/HD market open to novelties and pharmacy aggressive strategies
- A pool of high potential GPs still undertargeted and undervisited

- The need to prepare futures challenges in institutional and oncology markets
By

Improving interaction marketing/sales through a shared action plan to fit to each market opportunities
Increasing GPs target and therefore med reps number

Develop a patient centric approach to fit to doctor’s needs and real potential
Preparing the pillars for the new Servier markets (Oncology, biosimilars)

Page 11

Orientation Plan 2016/2017 Country: Central America and the Caribbean

O PRIENTATION LAN 2016 / 2017

Country: Central America and the
Caribbean

Product: Daflon 500 mg

PROJECT MANAGER: Aurélia Ballesteros

TO 6 914 659 Evolution (%)
Unit 669 152 +37%
Contribution to 36% +14%
subsidiary TO

Page 12

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Contents

1. SUMMARY ..................................................................................................................... 14
2. PRODUCT POSITIONING ............................................................................................. 16

2.1. Key figures ............................................................................................................. 16
2.2. Perceived product image ...................................................................................... 22
2.3. Perception of competitor products ...................................................................... 23
2.4. Feedback on product promotion .......................................................................... 24
2.5. Key environment-related facts.............................................................................. 26
2.6. Expected key items related to the product .......................................................... 27
2.7. SWOT analysis ....................................................................................................... 28

2.7.1 Strengths/Weaknesses - related to the product ............................................ 28
2.7.2 Opportunities/ Constraints -Threats - related to the environment............... 29
2.7.3 Diagnosis .......................................................................................................... 29
3. ORIENTATION............................................................................................................... 30
3.1. Strategic goal ......................................................................................................... 30
3.2. Promotional axis and main messages ................................................................. 30
3.3. Operational strategy (main strategic orientations in term of mediamix) .......... 31
4. APPENDIX ..................................................................................................................... 32

Page 13

Orientation Plan 2016/2017 Country: Central America and the Caribbean

1. SUMMARY

Based on sylogic data, with 669 152 units sold (+14% vs Y-1) for a gain of 6 914 659 USD
(+37% vs Y-1), daflon 500 represents 36% of the total market of the subsidiary.

Based on IMS data, daflon 500 mg is a strong leader prescribed in more than 50% of
cases. This success is the result of the historical leadership of daflon in the region and of
doctors´ very good experience with daflon 500 mg.
Daflon 500 mg´s leadership position was reinforced by a leader campaign offering to
healthcare professional a better support in the management of their patient suffering
from chronic venous and hemorrhoid disease (daflon 500 mg´s updated scientific data,
detection campaigns, innovative educational material for patients, regional MPI “Together,
we are leaders”), a closer relationship with KOLs, the extension of our promotion in
hemorrhoid disease and a better continuous medical education in CVD and HD.

But daflon 500 mg´s dynamism is not reflected in units: even if he still remains the
market leader with 33% of market share, daflon 500 mg is less dynamic than the market
(10% vs 13% growth vs Y-1). The loss observed between daflon 500 mg’s prescriptions
and units could be explained by the switch at pharmacists’ level, even when the patient has
a prescription. Daflon 500 mg´s competition is tough particularly face to daflon 500´ copies
and OTC treatment which have preferential commercial offers with pharmacies.

Moreover, despite the fact that CVD and HD are serious and progressive diseases that
need to be treated right from the first symptoms, many patients remain underdiagnosed
and undertreated.

Our strategy for the 2016/2017 exercise will consist in reinforcing our leadership strategy
for all actors involved in chronic venous disease and hemorrhoid disease by:

- Reinforcing daflon 500 mg´s scientific leadership and its position as the reference
treatment for doctors

- Extending our actions toward pharmacists
- Extending hemorrhoid disease promotion
- Increasing patients´ awareness and detection

Page 14

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Page 15

Orientation Plan 2016/2017 Country: Central America and the Caribbean

2. PRODUCT POSITIONING

2.1. Key figures

From IMS, MAT, 09/15 DAFLON 500 mg
C05C MARKET 369 458 units, +10.4%
986 084 units, +12.9% 6 838 179 $, +14.8%
18 455 080 $, +13.4%

The C05c market in Central America and the Caribbean is a dynamic market: +13% vs Y-1
in units and TO where Daflon 500 is the leader with 37% of market share and a growth vs
Y-1 of +15% in TO.

Nevertheless, the market is mainly driven by our copies, 8 in total which represent 12% of
market share in TO.

Page 16

Orientation Plan 2016/2017 Country: Central America and the Caribbean

In prescriptions, daflon 500 is the incontestable leader, prescribed in more than 50% of
cases. But this dynamism is not reflected into units: daflon 500 is less dynamic than the
market (10% vs 13% growth vs Y-1), even if he still remains the market leader with 33% of
market share.

+13%

The loss observed between daflon´s prescriptions and units is explained by the switch at
pharmacists’ level, even when the patient has a prescription.
This highlights the important role of pharmacists in disease management.

With the change this exercise of daflon´s obligatory prescription to non-mandatory
prescription status, we plan to have a complete pharmacy strategy. The objective is
double: avoid the switch and since 30% of patients go directly to pharmacy (Instar 2013
survey), encourage daflon 500´s recommendation by pharmacists.

Daflon´s top 3 contributing countries in private sales remains in order Costa Rica,
Panama, and Honduras. They represent 60% of daflon total sales in Central America and
the Caribbean.

Based on IMS data in TO, although Honduras has the biggest phlebotonic market of
Central America thanks to its population´ size, daflon 500 mg´s market share in Honduras
remains quite low face to the average in the region (30% vs 37%). We plan a retargeting of
most potential doctors in this country to increase daflon prescriptions. (IMS INTE
prescriptions: 66% CVD, 34%HD)

Page 17

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Key success factors for countries with the highest private sales growth and IMS growth
such as Panama and Republica Dominicana were:

- More investment in hemorrhoid disease indication,
- Closer relationship with KOL and scientific societies,
- Better continuous medical education within the country in CVD and HD with

the participation of KOL.

MAT 09/2015

countries daflon daflon daflon IMS daflon 500 countries daflon 30
contribution private sales institutional growth ($) MS IMS ($) position / average
growth ($) sales growth phlebotonic price (60
in daflon market ($) pack: x2 -5%)
private sales ($)

($)

16%

COSTA RICA 25% 23% NA (vs +18% 59% leader 2nd 18.48
PANAMA
market)

30%

19% 28% -2.5% (vs +21% 54% leader 5th 17.64

market)

HONDURAS 16% 9% NA 8% 30% leader 1st 18.65
(= market)

13%

NICARAGUA 11% 9% -64% (vs 15% 35% leader 6th 8.4

market)

4% 23%, 2nd

GUATEMALA 11% 9% -18% (vs +9% after 3rd 17.64

market) Nikzon

REP DOM 11% 50% NA NA NA 4th 15.79

EL SALVADOR 7% 27% NA 10% 20%, 2nd 7th 14.95
-19% (vs +12% after 16.6
TOTAL CA 100.0% 19% market) Nikzon

15% 37% leader
(vs +13%
market)

Institutional market is decreasing by 19%. Countries that are involved are Guatemala and
Nicaragua. In Guatemala healthcare system budget was decreased by 50% in 2015 due to

Page 18

Orientation Plan 2016/2017 Country: Central America and the Caribbean

corruption. In 2016, we expect to completely loose the institutional market in Guatemala
and Nicaragua due to aggressive copies pricing.

TARGETING
We have for the first time, the opportunity to have data of prescription from IMS INTE in
Central America. Based on those data we can see that GPs make 2/3 of phlebotonics´
prescriptions. While a gynecologist gives 9 prescriptions, a gastroenterologist or GP gives
21 and a surgeon gives 72. It is helping us to redefine our target and actions for this
exercise: increasing the panel of GPs visited (currently only 5% of total GPs and 25% of
total visited GPs by pharmaceutical companies in the region), increasing continuous
medical education toward GPs, maintaining our close relationship with surgeons dedicated
to chronic venous and hemorrhoid disease, increasing the number of gastroenterologists
visited.

Page 19

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Based on easymed data reported by sales rep, we can see that daflon´s doctors are moslty
trialists doctors (62%). Our challenge is to convert those trialists doctors into regular users
and champions by implementing some specific actions and promotion with the most
potential ones.

Doctors´ profile is defined as followed:

Daflon 500 Px >4 / week 2-3 / week 1 / week 0-1 / month
Trialist Non user
Doctor´s profile Champion Regular User

NOTORIETY IN CHRONIC VENOUS DISEASE
As a privileged partner for specialists in Chronic Venous Disease, we initiated notoriety
actions, such as an:

- An advisory board in CVD (with the participation of one leader from each country of
the region),

- Participation to international congresses (EVF St Petersburg, 7 invited doctors),
- We organized our first regional MPI in chronic venous disease “Together, we

are Leaders” with the international participation of the doctor Leal Monedero from
Spain. It was the first expert meeting in Chronic Venous Disease in Central America
and the Caribbean where we connected the most important KOL of the region (35
KOL in total from all the countries of the region).

Page 20

Orientation Plan 2016/2017 Country: Central America and the Caribbean

As clinical studies are fewly practiced in Central America and the Caribbean, we turned the
VEIN ACT program as a notoriety program and involved as national coordinators the most
important specialists of the region. We expect the results in Q3 2016.

KOL mapping in Chronic Venous Disease

NOTORIETY IN HEMORRHOID DISEASE
In order to become a privileged partner for specialists in hemorrhoid disease, we get
closer with proctologists’ societies and in some countries with gastroenterologists
societies. We developed more added value material for KOL in hemorrhoid disease.
Nevertheless, we still have an important work to do, and to develop this year more specific
actions with those KOL, such as the the planification of training program in coloproctology
and a specific advisory board dedicated to hemorrhoid disease.

Page 21

Orientation Plan 2016/2017 Country: Central America and the Caribbean

2.2. Perceived product image

Daflon 500 mg remains the 1st choice phlebotonic treatment for chronic venous disease
and hemorrhoid disease in Central America and the Caribbean.

Qualitative survey realized by sales reps to doctors, in chronic venous disease

Clinical leg examination is the most common CVD detection in routine consultation.
Moreover the major patient profile for daflon 500 mg is a patient with signs and
symptoms. Patients C0s with pain without visible remain underdiagnosed and
undertreated.

The 2 main criteria to judge a treatment efficacy is its rapidity of action and reduction
of the pain reported by the patient. New messages on the prevention of disease
evolution and the prevention of reflux aren´t yet reasons of prescriptions.

The first reason why doctors prescribe daflon 500 is for its clinical efficacy. It is confirmed
by their positive experience with daflon 500 mg in daily life. Another important reason
to prescribe daflon 500 is its reference in the international guidelines and studies.

In another hand, the most important reason for no prescribing daflon 500 is its price,
showing that we still have to convince doctors of the high added value of daflon 500
compared with the other drugs.

Qualitative survey realized by sales reps to doctors, in hemorrhoid disease:

The main reasons to prescribe daflon 500 mg is its efficacy on pain and rapidity of action,
its efficacy in stopping bleeding and doctor´s positive experience.

Main reason for not prescribing daflon 500 mg is its price.

Qualitative survey realized by sales reps to pharmacists:

Their experience with daflon 500 mg is very good in term of efficacy, ease of use and
price but poor in term of commercial conditions and advertising investment of the

Page 22

Orientation Plan 2016/2017 Country: Central America and the Caribbean

company compared with competitors. It is also necessary to create added value of daflon
500 mg and to find new ways of promotion in pharmacies.

In conclusion, daflon 500 benefits from a positive image at both doctors and pharmacies
level. He´s considered as the reference treatment. Nevertheless, at doctors level, it is still
necessary to create higher added value with daflon 500 in order to differentiate him
from the others competitors and confirm his leader position and price.

At pharmacists’ level, even if daflon 500 is considered as the reference treatment, it is still
not the most preferred brand. The change to non-obligatory prescription status will be
an opportunity to have a complete pharmacy strategy and increase daflon 500´s
sales at pharmacies level.

Moreover, as there are still many patients underdiagnosed and undertreated, we have an
opportunity, as the leader of the market to sensibilize doctors and pharmacists to the
importance to detect and treat those patients with daflon 500.

2.3. Perception of competitor products

Competition is wide, tough, diversified and different depending on the countries.
Our main competitors in terms of uplift are daflon 500 mg copies, and Nikzon.

Page 23

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Daflon 500 mg copies (1st uplift in the C05C market). They are 8 in total: Venartel,
Phlebodia, Diosmil, Diosmina+hesperidina, Vedipal, Flomacor, Diatonb, fleboxin500.
Flomacor and Fleboxin 500 are from local laboratory from Dominican Republic. They are
promoted and commercialized as MPFF. Venartel communicate on his “micronized 2.4μm
and purified” formulation”. Those competitors are very present in doctor’s cabinet in terms
of branding with posters, patient pad and gimmicks. They communicate that they are the
same as daflon 500 mg but cheaper and they have many commercial agreements with
distributors and pharmacies.

Nikzon (2nd uplift in the C05C market, +12% of growth in TO)
Nikzon from Gennoma Lab, a Mexican company is an indirect competitor, not promoted
to doctors. He´s made of a combination of ruscus aculeatus, lactobacillus and ascorbic
acid. It´s an auxiliary treatment indicated in hemorrhoid disease and promoted only on
TV spot and pharmacies. Their branding is “with Nikzon, I´m feeling in the cloud”.
Promotion on TV spot is based on the medicalization of the disease. There is a doctor
explaining symptoms and complications with visual picture of hemorrhoids and short video
of hemorrhoidectomy and promoting Nikzon to prevent from such complications.
Doctors have a very bad perception of Nikzon: first because is taking them out patients and
then because they see many patients not alleviated which come back after having taken
Nikzon for a while.

In conclusion, although doctors perceive DAFLON 500 as the leader in the market,
they are also influenced by the strong promotion of competitors: medical calls,
brand reminders…and pharmacies are playing an important role in the switch of
prescription or direct sales to patients. It highlights the importance to differentiate
daflon 500 mg from other competitors confirming his leadership position by
developing action at high added value and having a complete pharmacy strategy.

2.4. Feedback on product promotion

In order to be a privileged partner of healthcare professional in chronic venous and
hemorrhoid disease, we developed a leader campaign to offer to healthcare

Page 24

Orientation Plan 2016/2017 Country: Central America and the Caribbean

professional a support in the management of their patient: daflon 500 mg´s updated
scientific data, detection campaigns, innovative educational material for patients, regional
MPI “Together, we are leaders”.

Our communication was focused on daflon 500´s unique anti-inflammatory and
venoprotective actions to rapidly relieve pain, to prevent from complications and to
preserve venous capacity. The MPFF was used to explain direct patients benefits: 5
synergic components for more efficacy, purification for more quality and micronization for a
rapid relief. As well, daflon 500 mg´s unique action on venous valves and walls highlighted
in international guidelines and daflon 500 mg´s recommendation in first position in
international guidelines were used to confirm daflon 500 mg´s unique anti-inflammatory and
venoprotective action and its leadership position.

Unique anti-inflammatory action

Daflon 500 mg´s efficacy on rapidly relieving pain is well recognized by doctors and they
have a very good experience of it. Daflon 500 mg superior efficacy on rapidly relieving pain
compared to other drugs such as daflon 500 mg´s copies is not so clear for some doctors.
To communicate on the benefits of daflon 500 mg´s unique MPFF and daflon 500 mg´s first
position in international guidelines helped to convince those doctors. Nevertheless, there
are still doctors to convince and to go further in order that doctors are able to convince their
patients not to change the prescription in pharmacy.

Unique venoprotective action

To convince doctors about the importance of preventing venous reflux and chronic venous
disease progression is not so easy, as it is something new for them to consider C0s
patients as patient to be detected and treated. It will require more time, in order that they
assimilate and integrate it automatically to their daily practice and in order to be convinced
about daflon 500 mg´s unique action on venous valves and walls to protect from further
deterioration.

Privileged partner for healthcare professional

Doctors feel that Servier and Daflon 500 mg are much more present and closer to them.

Page 25

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Launch of daflon 500 mg, 60 tablets

For more commodity, adhesion to treatment and economy for the patient, we launched
daflon 500 mg, 60 tablets (25% of daflon total sales after 3 months of active promotion)
through an active “I love 60´s” communication.

2.5. Key environment-related facts

Based on INSTAR 2013 study, when a patient is suffering from chronic venous disease or
hemorrhoid disease:
- 60% of them consult a doctor. After the consultation, in 30% of cases, pharmacists will
suggest to switch the treatment prescribed.
- 30% of patients go directly to the pharmacy and in 35% of the cases pharmacists
suggest a specific product.

Based on IMS data, almost 30% of phlebotonic prescriptions are for hemorrhoid
disease. Taking into consideration Nikzon results (auxiliary treatment for hemorrhoid
disease, only TV promotion, 3rd uplift of the C05C market), the percentage of patients in
Central America and the Caribbean going directly to pharmacy for hemorrhoid disease is
probably exciding 30%.

Those data highlight the opportunity of growth that we have at promoting those
indications and particularly the hemorrhoid indication at pharmacists’ level and also
by obtaining doctors’ compromise to explain to their patients why not changing their daflon
500 mg´s prescription at pharmacy.

Page 26

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Based on the Vein Consult Program, 80% of patients seeking for care whatever the reason
are suffering from chronic venous disease. On these 80%, only 2 out of 10 patients
spontaneously consult a doctor (mostly at advanced stages), which highlight that they are
many undiagnosed and undertreated patients especially at early stages that could
benefit from daflon 500 mg´ unique properties in preventing complications and
preserving venous capacity.

2.6. Expected key items related to the product

Non obligatory prescription status

We are expecting the daflon 500 mg´s non obligatory prescription status change in Q2
2016, which will allow us to have a more complete pharmacy strategy in order to avoid the
switch and encourage daflon 500´s recommendation by pharmacists.

Launch of daflon 1000 mg oral suspension and tablet

We expect also the launch of daflon 1000 mg oral suspension in Q3 2016 and daflon
1000 mg tablet in Q4. It will be a tremendous opportunity to reinforce our leadership
position in the market, to increase patient adherence, to gain new patients and to regain
institutional market.

New scientific data

- to reinforce Daflon’s mode of action and efficacy, thanks to new studies on:
o The factors of venous inflammation
o The preservation of venous valves morphology
o The symptoms and signs

- To support daflon efficacy among new patients particularly in association with
endovenous treatment of varicose veins.

- to develop disease awareness through programs and consensus documents:
o The Vein Act Program to understand better what prompt the 1st prescription
in symptomatic patients (Q2 2016 UIP Roma).
o The SymVein document to reach a consensus and define the term “venous
symptoms”.

Page 27

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Local results of the Vein Act Program

We expect the results of our local Vein Act Program in Costa Rica, Panama, Dominican
Republic and Guatemala for Q3.

2.7. SWOT analysis

2.7.1 Strengths/Weaknesses - related to the product WEAKNESSES
STRENGTHS

Perceived by the doctor Perceived by the doctor

 Rapid efficacy in relieving symptoms  High perceived price
 Anti-inflamatory action  Lack of perceived investments at
 Positive product experience
pharmacists´ level

Not perceived by the doctor Not perceived by the doctor

 Superior efficacy  Loss of institutional market in
 Preservation of venous capacity / Guatemala

limitation of disease evolution
 Benefits of the unique micronization

and composition

 Change of daflon 500 mg´s status to
non-mandatory prescription status to
increase promotion and actions at

Page 28

Orientation Plan 2016/2017 Country: Central America and the Caribbean

pharmacists level
 Launch of daflon 1000 mg --> new

patients + reconquest institutional
market

2.7.2 Opportunities/ Constraints -Threats - related to the environment

OPPORTUNITIES CONSTRAINTS-THREATS

 Underdiagnosed and undertreated  Wide, tough and diversified
patients in both indications competition (copies, OTC)

 More investments in hemorrhoid  CVD and HD are not perceived as a
disease serious disease

 Increasing GPs´ panel

2.7.3 Diagnosis

-Even if daflon 500 mg remains doctors´ treatment of choice, he´s losing market share,
particularly at pharmacists´ and patients´ level.

-Gps are under visited compared to their important potential.

-Patients in CVD and HD are undertreated and under diagnosed.

Page 29

Orientation Plan 2016/2017 Country: Central America and the Caribbean

3. ORIENTATION

3.1. Strategic goal

To develop a real leadership strategy for all actors involved in chronic venous disease and
hemorrhoid disease by:

- Reinforcing daflon 500 mg as the reference treatment for doctors
- Extending our actions toward pharmacists
- Increasing patients´s awareness and detection
- Increasing GP´s panel and GP´s continuous medical education

3.2. Promotional axis and main messages

Specialists in chronic venous disease

As chronic venous disease is a serious and progressive disease, you should prescribe
daflon 500 mg, the reference treatment, whatever the stage of the disease, and in
association with endovenous procedures to rapidly relieve patients and accelerate their
recovery, thanks to its unique anti-inflammatory and venoprotective action

Specialists in hemorrhoid disease

As hemorrhoid disease is a serious and progressive disease, you should prescribe daflon
500 mg, the reference treatment, whatever the stage of the disease, and in association with
instrumental methods to rapidly relieve patients and stop their bleeding, thanks to its
unique anti-inflammatory and venoprotective action

GPs

As chronic venous and hemorrhoid disease are serious and progressive diseases, you
should prescribe daflon 500 mg, the reference treatment, whatever the stage of the

Page 30

Orientation Plan 2016/2017 Country: Central America and the Caribbean

disease, to rapidly relieve patients and preserve their venous capacity, thanks to its unique
anti-inflammatory and venoprotective action

Pharmacists

As chronic venous and hemorroidal disease are serious and progressive diseases, patients
need to be treated right from the first symptoms with the reference treatment, daflon 500
mg.

Patients

Pain, heaviness and swelling / pain and bleeding are the first symptoms of chronic venous /
hemorrhoid disease, 2 serious and progressive diseases that need to be treated right from
the start by the treatment the most used worldwide, that can be advised by your healthcare
professional

3.3. Operational strategy (main strategic orientations in term

of media mix)

• Extend the market and benefit more patients with an earlier diagnostic and
daflon 500 mg´s treatment

• Develop more hemorrhoid disease indication
• Differentiate daflon 500 mg from competitors confirming his leadership position

by developing action at high added value
• Limit switch at pharmacists level and increase daflon 500 mg´s

recommendation by pharmacists
• Launch of daflon 1000 mg
• Increase GPs panel and GP´s continuous medical education

Page 31

Orientation Plan 2016/2017 Country: Central America and the Caribbean

4. APPENDIX

IMS MAT SEPT 2015

Panama Costa Rica HondurasGuatemalaNicaraguaEl Salvador TOTAL CA

C05C MARKET (UNIT) 117,721 144,617 205,521 164,627 231,166 122,432 986,084

growth (UNIT) 13.5 11.5 6.3 10.3 13.3 33.6 12.9

C05C MARKET (TO) 2,548,900 3,510,275 4,776,096 3,324,889 2,243,292 2,013,051 18,455,080

growth (TO) 20.9 18.0 9.2 8.5 14.8 12.0 13.4

Panama Costa Rica Honduras GuatemalaNicaragua El SalvadorTOTAL CA

DAFLON 500 (UNIT) 73,365 92,263 58,412 36,743 84,102 24,573 369,458

Growth(UNIT) 21.5 9.8 2.0 1.0 13.0 10.0 10.4

MS (UNIT) 60.3 57.7 27.4 22.0 34.7 19.9 35.6

EV 108.6 98.5 96.0 91.6 99.7 82.4 97.7

DAFLON 500 (TO) 1,372,637 2,066,874 1,415,265 761,152 793,923 408,194 6,838,179

Growth (TO) 28.8 16.4 8.2 3.5 13.4 9.7 14.8

MS (TO) 53.9 58.9 29.6 22.9 35.4 20.3 37.1

EV 106.6 98.6 99.1 95.4 98.8 98.0 101.2

Page 32

Orientation Plan 2016/2017 Country: Central America and the Caribbean

O PRIENTATION LAN 2016 / 2017

Country: Central America & Caribbean

Product: Vastarel MR

PROJECT MANAGER: Alexa Ochoa

TO 3,165,394 Evolution (%)
Unit 369,898 -5
-5
Contribution to 14%
subsidiary TO

Page 33

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Contents

1. SUMMARY ..................................................................................................................... 14
2. PRODUCT POSITIONING ............................................................................................. 16

2.1. Key figures ............................................................................................................. 16
2.2. Perceived product image ...................................................................................... 22
2.3. Perception of competitor products ...................................................................... 23
2.4. Feedback on product promotion .......................................................................... 24
2.5. Key environment-related facts.............................................................................. 26
2.6. Expected key items related to the product .......................................................... 27
2.7. SWOT analysis ....................................................................................................... 28

2.7.1 Strengths/Weaknesses - related to the product ............................................ 28
2.7.2 Opportunities/ Constraints -Threats - related to the environment............... 29
2.7.3 Diagnosis .......................................................................................................... 29
3. ORIENTATION............................................................................................................... 30
3.1. Strategic goal ......................................................................................................... 30
3.2. Promotional axis and main messages ................................................................. 30
3.3. Operational strategy (main strategic orientations in term of mediamix) .......... 31
4. APPENDIX ..................................................................................................................... 32

Page 34

Orientation Plan 2016/2017 Country: Central America and the Caribbean

1. SUMMARY

 Market:
The stable coronary artery disease market in Central America and the Caribbean represents
2,763,263 in units, USD 42,758,356 in value and has a positive dynamism +4%, lead by the Beta
Blockers.

The Angina market represents 7% of the CAD market, 307,124 in units, USD 3,361,609 in value.
The class of coronary therapy plays an important role in the treatment of Angina and is led
by Vastarel MR and represents 77% of the market share, with a total growth of -8% (IMS MAT
units 10.2015).

 Vastarel MR sales:
Vastarel MR is the second product in SCAC portfolio in value and units with 26% of the
subsidiary sales, so it is necessary to boost our sales, that is the reason why it´s working
currently as one of the subsidiary priority products.

Costa Rica is the country with the biggest contribution in units (33%) and values (26%) for Vastarel
MR, followed by Panama (16%) and El Salvador (16%). The rest of the countries have a very
similar sales contribution, which makes us see that every country in the region is very important
for Vastarel MR.

 Promotion:
The number of med reps promoting Vastarel MR in the region was doubled in octuber 2015, from
12 med reps to 27, is a great opportunity to have a bigger team in the region, to positioning
Vastarel MR as an effective anti-anginal treatment.

 Product image:
In terms of image on the product in the region, the increased of energy in the ischemic
myocardium of Vastarel MR is not perceived as a benefit for the angina patient, we have to
work in differentiate ourselves from other treatments, for the unique benefits to provide more
energy to the ischemic heart.

Page 35

Orientation Plan 2016/2017 Country: Central America and the Caribbean

 Goal:
We thus have to:
 Develop an awareness program at regional level about the important role that energy

plays in ischemic heart disease
 Highlight the importance of energy supply for the ischemic* patient, demonstrating the

powerful anti anginal and anti-ischemic efficacy of Vastarel MR, because of its unique
improvement of energy to the ischemic heart.

*angina, post MI, HF, diabetics, pre/post revascularization

Page 36

Orientation Plan 2016/2017 Country: Central America and the Caribbean

2. PRODUCT POSITIONING

2.1. Key figures

Stable coronary artery disease market:
2,763,263 units – USD 42,758,356 values (IMS MAT 09.2015)
C7A: Beta blockers: 48% in units +5%
C8A: CCB: 38% in units +3
C01E: Nitrates 2% in units -9%
C01D: Coronary Therapy: 11% in units -3

The Stable coronary artery disease market in Central America and the Caribbean has a positive
dynamism +4 (IMS MAT 10.2015) and is led by Beta blockers which have a positive trend, as a
second alternative are the CCB that are also growing, followed by the class of Coronary Therapy
that presented a decrease.

IMS MAT 10.2015

The stable coronary artery disease market is a very dynamic market, we can have many
opportunities to growth with Vastarel MR if we expand our message not only to the angina market
but also to all ischemic patients such as diabetics patients, post MI patients, pre/post revascularized
patients and Heart Failure patients, through the development of Vastarel MR clinical proofs for
those patients.

Page 37

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Coronary Therapy market:
307,124 units – USD 3,361,609 values (IMS MAT 09.15)
Vastarel MR 77% in units -8%
Procoralan 11% in units +16%
Ranexa 6% in units +19%
Generics Trimetazidine 6% in units

INTE MAT 10.2015

The Angina market represents 7% of the stable coronary artery disease market and is led by the
Coronary Therapy C01D, demonstrating the importance of class C01D in the treatment of
angina.

The Coronary Therapy according IMS 09.2015 is decreasing -3% in MAT, but shows a trend of
improvement versus the previous year in That was -6%.

Vastarel MR leads the Coronary Therapy market (C01D) with a 77% market share, and a total
growth of -8%, according to IMS in September 2015.

Vastarel MR is losing prescriptions, for the indication of vertigo, Vastarel MR is gaining
prescriptions in the angina treatment, but still doesn´t compensate the lost of vertigo prescriptions,
our goal is to win more prescriptions for angina than we lose by Vertigo.

Prescriptions Vastarel MR in units 2014 vrs 2015

Growth % Uplift Vértigo Uplift Angina Uplift Others

-3 -5,036 1,149 862

Page 38

Orientation Plan 2016/2017 Country: Central America and the Caribbean

INTE MAT 06.2015
Procoralan and Ranexa also participate in the Coronary Therapy market and have a good
position as Antianginal treatment, both products shows a good dynamism of growth,
Procoralan maintains its growth versus last year and Ranexa after the first years of Its launch, also
maintains a positive growth trend, but is losing its dynamism.

This shows that we can grow inside our therapeutic class and our goal is to be the fastest
anti anginal treatment in the C01D class.

IMS MAT 09.2015

 Local sales
Vastarel MR is the second product in SCAC portfolio in value and units with 26% of the
subsidiary sales, so it is necessary to boost sales and that is the reason why it is working currently
as one of the subsidiary priority products.

Servier CAC portfolio values

1% 1% 0%
3% 3%
3% DAFLON
VASTAREL MR

4% NATRILIX
5% 39% DIAMICRON-MR
6%
PROCORALAN
9% COVERSYL
COVERAM

9% PRETERAX
PROTELOS
17% VALDOXAN

Page 39

Orientation Plan 2016/2017 Country: Central America and the Caribbean

IMS MAT 09.2015
In recent months Vastarel MR is showing a lineal trend in local sales across the region, the
growth of Vastarel MR in September 2014 was -6%, with 257.856 units at year-end, right now we
are growing in the last trimester by +3%. (Suivi des ventes units 11.2015)

Sales Units % Value USD %
Private 257,856 -6% 2,777,589 -2%
Public 145,050 10% 1,034,086 -12
Total 402,906 1% 3,811,675 -4

SUIVI DE VENTES 09.2015

SUIVI DE VENTES QTR 11.2015
Costa Rica is the country with the largest contribution to sales in units and values for
Vastarel MR, it presents a decrease of -9% (IMS MAT units 09.2015), followed by Panama and El
Salvador, with a growth in both countries of -2%, the rest of the countries has a very similar sales
contribution, which makes us see that every country in the region is very important for Vastarel
MR.

Page 40

Orientation Plan 2016/2017 Country: Central America and the Caribbean

SUIVI DE VENTES 09.2015
The Vastarel MR team at regional level suffered of many vacancies and staff turnover,
especially in Costa Rica, which is the most potential market in the treatment of angina and our
biggest to sales (IMS 09.2015), what has prevented to have constant visits to doctors and to get our
message to our prescribers.

The number of med reps promoting Vastarel MR in the region was dobled in octuber 2015
from 12 med reps to 27, 12 med reps of Aire team, this team are working in the first position
Vastarel MR and 15 new med reps of Agua team working Vastarel MR as a third product, which will
increase the number of contacts for Vastarel MR.

In conclusion:
 The class of coronary therapy plays an important role in the treatment of Angina and is

led by Vastarel MR, indicating the need for the doctors to use treatments of 2nd and 3rd
line for angina patient.
 Each country is important in terms of contribution to sales in the region of Vastarel MR.
 Is a great opportunity to have a complete team with a higher number of Med Reps in the
region, to achieve a better brand positioning as an effective anti-anginal treatment for
patients with angina.

Page 41

Orientation Plan 2016/2017 Country: Central America and the Caribbean

2.2. Perceived product image

The three main reasons why cardiologists prescribe an anti-anginal treatment are: reducing
angina attacks, anti-ischemic protection and improved prognosis.

Vastarel MR Qualitative Survey SCAC 2015
The doctor recognized the reduction of the angina attacks with Vastarel MR, which is the
first reason for prescribing an anti anginal treatment, also considered as benefits of Vastarel
MR the good tolerability, improvement the quality of life and an affordable price, but they still
prescribe Vastarel MR as a last option of the treatment.

Vastarel MR Qualitative Survey SCAC 2015

Vastarel MR Qualitative Survey SCAC 2015
Page 42

Orientation Plan 2016/2017 Country: Central America and the Caribbean

The Increased of energy in the ischemic myocardium of Vastarel MR is not perceived as a
benefit for the angina patient, we have to work in differentiate ourselves from other
treatments.

The doctor thinks in 91% the angina is caused by a mismatch between oxygen demand and supply
and not yet considered that the energy plays an important role in treatment of angina.

Vastarel MR Qualitative Survey SCAC 2015
Vastarel MR still has a good brand positioning as a treatment for vertigo, highly recognized
brand in the region and most of our prescriptions still come from vertigo or other indications and
when compared with Procoralan that within our therapeutic class C01D have the best performance,
we observe its good positioning in Angina.

INTE MAT 06.2015

Page 43

Orientation Plan 2016/2017 Country: Central America and the Caribbean

The perceived weaknesses of Vastarel MR are:
 It´s not be a first-line treatment according to international guidelines for the management of

patients with angina
 The perception of doctors of the small quantity of patients in our studies and not actual studies
 We do not have mortality studies and we are not approved by FDA,

All of this makes makes Vastarel MR prescribed in most cases as a last option of the
treatment.

 Patients profile
The profile of patients where doctors have greater acceptance in using Vastarel MR, are the
profiles that are currently promoting in the campaign, except for the revascularized patients, where
we have to present more evidence to the doctors to convince of Vastarel MR in this type of patients,
but we see a new opportunity in the elderly angina patient.

Vastarel MR Qualitative Survey SCAC 2015
In conclusion:
 Our promotional message must be based on the anti-anginal efficacy of Vastarel MR,

since its the # 1 reason for the doctors to prescribe an anti-anginal therapy.
 We have to develop an awareness program at regional level about the important role that

energy plays in ischemic heart disease

Page 44

Orientation Plan 2016/2017 Country: Central America and the Caribbean

 We have to differentiate Vastarel MR from other angina treatment, for the unique benefits
to provide more energy to the ischemic heart in angina diabetics patients, elderly and
angina patients with revascularization.

2.3. Perception of competitor products

The Angina market in Central America and the Caribbean is led by the class of coronary
therapy, demonstrating that there is a great growth opportunity for Vastarel MR and is
increasingly common for the doctor to look in the Coronary therapeutic class one alternative for the
treatment of patients with angina.

 Beta - blockers:
The Beta blockers are leading the stable coronary artery disease market and also play an
important role in the treatment of angina, being part of the first-line treatment for the
management of angina patients, they have evidence to improvement prognosis of patient
angina, this is a point in its favor, it is the first choice in the treatment of CAD.

Our strategy is based on the combination of Vastarel MR to Beta blocker, so it is regarded
as an ally and not as our direct competitor.

 Nitrates:
Short-acting nitrates have good positioning as an effective treatment for angina crisis, low price is
well accepted by doctors, but the presence of adverse side effects in LAN as headache and cannot
be combined with treatments for dysfunction sexual is a limitation for use.

 Calcium Chanel Blockers:
The CCBs are an alternative for doctors when they have reached the maximum dose of beta-
blocker and usually used to its maximum dose until the patient has side effects, they doesn't count
with active promotion for the treatment of CAD.

 Ranexa (Ranolazine):
Ranexa is one of our main competitors; It´s a metabolic treatment for CAD and also is a part of
the Coronary Therapy class C01D. His message is based on the reduction in angina attacks,
the nitrate consumption and improved exercise capacity and an excellent option for the
diabetic patient. They do not have a clear mode of action, neither a reliable scientific evidence, but

Page 45

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Ranexa has a large team of med reps in the whole region, a large budget and a constant
participation in local and international scientific congresses. They have generated a strong
promotion against Vastarel MR. They want to develop doubts about the mode of action of MR
Vastarel, its safety and anti anginal efficacy.

 Generics:
The generics of Trimetazidine are prescribed mostly for the indication of vertigo, at regional level
every day are more generic, with the greatest positioning Vasocor, but so far none makes a direct
promotion for CAD. In pharmacies many recipes of Vastarel MR are changed by generic, for push
money o for some agreements among distributors and pharmacies, there is no significant
difference in price between generics and Vastarel MR.

2.4. Feedback on product promotion

The message of our campaign is to convince the doctor to prescribe Vastarel MR in
combination with hemodynamic agents, to a define patients profiles by its anti-anginal, anti-
ischemic efficacy and improved quality of life.

The CLASSICA study of Nesukay has had a very good acceptance by doctors, because the anti-
anginal efficacy of Vastarel MR is validated in combination with other hemodynamic agents,
besides being a new study of 2014 and a considerable population (1213 patients with angina).

Patient profiles of the campaign:
 Patient with angina treated with hemodynamic agents
 Patient with diabetic angina
 Patient with angina after revascularization

The doctor highlight how fragile is the diabetic patients with angina and that it finds a great ally in
Vastarel MR.

The message of the unique mechanism of action of Vastarel MR, "With less oxygen produces
more energy" must be reinforced with an awareness campaign in the doctor about the
importance of energy supply in patients with angina.

In conclusion:
 The three patients profiles presenting on the campaign allows the doctors to identify

more easily in what patient use Vastarel MR.

Page 46

Orientation Plan 2016/2017 Country: Central America and the Caribbean

 The patients profile should be kept in the following campaigns and even find new
potential profiles.

 Is a need to increase the communication in our message of the anti-anginal efficacy of
Vastarel MR as a central point of our campaign.

2.5. Key environment-related facts

 Epidemiological data:
In Central America, chronic diseases are now the leading cause of premature mortality and
disability in the vast majority of countries. The dietary pattern is a key factor leading to a rise in
prevalent overweight and obesity. Population–based surveys from Central America show that, in
2002, 50% to 60% of adults and 7% to 12% of children less than 5 years of age were overweight or
obese.

In 2005 in Central America, 31% of all deaths were attributable to cardiovascular diseases.
Predictions for the next two decades include a near tripling of ischemic heart disease and stroke
mortality in Central America. Concerning the CAD, the prevalence in the region is from 8%. So for a
population of 54 million of habitants, the number of people with a CAD is more than 4 million.

About recommendations of the health authorities, it is very important to enhance the confirmation of
the positive benefits-risk balance of Vastarel MR published by the EMA.

 Guidelines:
Vastarel MR is clearly visible in the ESC Guidelines; in the medical algorithms as a 2nd line
treatment in the management of patients with stable coronary artery disease. This is a great
support for Vastarel MR and we need to get more advantage of it.

The Cardiologists are following mostly the American guidelines of Coronary Artery Disease, where
Vastarel MR is not mentioned.

 KOL Mapping:
We have new leaders for Vastarel MR at regional and national level, standing out
cardiologists of Panama, Costa Rica and Honduras, countries with significant sales
contributions to Vastarel MR.

Page 47

Orientation Plan 2016/2017 Country: Central America and the Caribbean

It is necessary to maintain and develop good relationships with our cardiologists, to get our
message with more credibility during our activities and keep expanding their experience with
Vastarel MR.

 Targeting
The highest percentage of our prescriptions come from the GP's, who still prescribe much Vastarel
MR for vertigo, but those with the greatest potential for angina are cardiologists and that is where
we should focus our actions, the Red Aire is managing Vastarel MR as a priority product.

Doctors by specialty visited with Vastarel MR
during Cycle 1

OTHERS CARDIOLOGIST
6% 26%

INTERNIST
30%

Gp´s
38%

Easymed 11.2015

Page 48

Orientation Plan 2016/2017 Country: Central America and the Caribbean

NUMBER

PRESCRI PTI ONS MED PRESC/MED
64,233
GP´S 14,047 31,757 2
INTERNIST 11,261
CAR D I OLOGI S T 4600 2,701 5
OTROS
967 12

INTE MAT 06.2015

Conclusion:
 It is necessary to adjust the panel in Red Aire to increase the number of cardiologists

visited to optimize our actions and boost our sales.

2.6. Expected key items related to the product

We are expecting the results of the ATPCI study: The efficacy and safety of Trimetazidine in
Patients with angina pectoris having been treated by percutaneous Coronary Intervention.

We also are waiting for the VASTAREL OD 80mg to be launched in 2017.

2.7. SWOT analysis

2.7.1 Strengths/Weaknesses - related to the product WEAKNESSES
STRENGTHS

Page 49

Orientation Plan 2016/2017 Country: Central America and the Caribbean

Perceived by the doctor Perceived by the doctor

 Recognized Brand  No FDA approval
 Excellent tolerability and safety  Third line in CAD guidelines
 Improves quality of life  Small quantity of patients in the studies
 Good previous experience
 Affordable Price and old studies
 Do not have mortality studies

Not perceived by the doctor Not perceived by the doctor

 Unique mode of action 
 Reduction of angina attacks 
 Powerful anti-ischemic efficacy 
 Reducing mortality demonstrated in

several studies
 Unique benefits for ischemic patients

2.7.2 Opportunities/ Constraints -Threats - related to the environment

OPPORTUNITIES CONSTRAINTS-THREATS

 Huge reservoir of patients in the region  Change of prescriptions in some
 Growing CAD Market pharmacies for generic
 ATPC study
 Launch of Vastarel OD 80mg  New competitors
 Generics do not promote angina

2.7.3 Diagnosis

Page 50