BrazilianPharmaceu/calFieldFiguresByLadinaConsul.ng-Brazil

Socio-demographics & GDP

Population projection in July 16, 2015 (IBGE):

2

Number of pharmacies and physicians

184pharmaciesper1000physicians

37pharmaciesper100kpopula/on

2.272 11.541

61.056

Independent Chains (Franchise) Chains

Independent Pharmacies

Numberofphysicians:406.872

NumberofPoS(pharmacies):74.869

CFM(FederalCouncilofMedicine)3

Annual average exchange rate BRL/USD

4

Key Macroeconomic Indicators

5

RetailMarketAnalysisByLadinaConsul.ng-Brazil

Brazilian Pharmaceutical Market

7

Top 25 companies

8

9

2014 – Total Sales Market

10

Retail Sector Sales

Brazilian Pharmaceutical Market

11

Brazilian Pharmaceutical Market Per product type

12

13

Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture 2013,pg 5

Brazilian Market Pharma – Units Sold

14

Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture 2013,pg 7

Brazilian Market Pharma – Commercial Deficit – Participation of Importation in the market $ Br Reais

15

Business Environment

16

Healthcare Provision

17

Pricing and Reimbursement

18

Regulatory Environment

19

Pharmaceutical Business Environment

20

Pharmaceutical Business Environment

.

21

Pharmaceutical Business Environment

ANALYSIS OF REBATES AND DISCOUNTS

22

New Competitive Scenario : Main Pressures Of Pharmaceutical

Industry in Brazil ByLadinaConsul.ng-Brazil

Source : BNDS (Banco Nacional de Desenvolvimento Social) Market Picture- 2013

Industry Competition

Strengthening retail and

institutional paying

Regulatory Changes

Shortage molecules patent to

expire

Pharmaceutical Industry

Pressure on Prices

New Competitive Scenario : Main Pressures Of Pharmaceutical Industry in Brazil

24

Market Prognosis Scenario 2015-2019: Pricing and Reimbursement

CMED : Camara de Regulação de Mercado de Medicamentos (Pharmaceutical Market Regulatory Agency- Pricing Commission)

25

Mechanisms applied by CMED and the information that applicants must include in pricing dossiers are determined by the classification of a new

drug into one of six categories:

CMED : Camara de Regulação de Mercado de Medicamentos (Pharmaceutical Market Regulatory Agency- Pricing Commission)

26

Generic prices

27

Price increases

28

Public sector prices

29

Influence of Tax to choice best place to implement t Business

30

OncologyByLadinaConsul.ng-Brazil

Market Studies Selected Oncology Molecules

ByLadinaConsul.ng-Brazil

Selected molecules

Selec.oncriteriaThese10moleculeswereselectedbythefollowingcriteria:•  HighersalesinUSD•  BeGergrowthtrend•  Fewerplayers•  BeGeraverageprice

33

2.373

3.5194.096

4.663

5.595

2011 2012 2013 2014 2015

Units (000)

+48%

140.400141.867

146.851

156.106

160.424

2011 2012 2013 2014 2015

USD (000)

73.743

112.602

133.011

153.681

181.328

2011 2012 2013 2014 2015

Tabs (000)

+16% +14% +20% +1% +4% +6% +3% +53% +18% +16% +18%

CAGR+24%

CAGR+3%

CAGR+25%

Numberof

Players:

12

34

20mg48%

10mg37%

40mg13%

80mg2%

Sharebystrength,inunits

35

Sharebyproducttype

5,4% 8,8% 7,2% 7,1% 10,8%32,2%

61,3% 66,1% 67,3% 68,4%

62,5%30,0% 26,8% 25,6% 20,8%

2011 2012 2013 2014 2015

BRANDEDGENERIC NON-BRANDEDGENERIC ORIGINAL

3,0% 6,3% 5,2% 4,6% 6,4%23,8%

48,3% 53,8% 54,7% 56,2%

73,1%45,4% 41,0% 40,7% 37,4%

2011 2012 2013 2014 2015

BRANDEDGENERIC NON-BRANDEDGENERIC ORIGINAL

UNITS

USD

36

Averagediscountperplayer

Rankinginvalues

37

30.278

25.156

2014 2015

Units 27.890

18.305

2014 2015

USD (million)

-34%

38

Regulatory Path

for Registering imported products in Brazil

ByLadinaConsul.ng-Brazil

Introduction

40

Ways to Register in Brazil

41

Timelines for subsidiary opening 1

42

Comparison between scenarios 1 and 2

43

Timelines for registration 1

PE : Pharmaceutical Equivalence BE : Bioquivalence COA: Certificate of Analysis

44

Timelines for registration 2

45

Check list for registration of Imported Finished Products ( Generic and Branded Generic) 1

BMRs : Batch Manufacturing Record RLD : Reference Listed Drug CRO : Certified Research Organization

46

Required documents for GMPc Application

47

Basic Requirements to Sell API in Brazil 1

48

Basic Requirements to Sell API in Brazil 2

List of APIs that must have GMPc of the manufacturing facility and registration at ANVISA.

49

Basic Requirements to Sell API in Brazil 3

50

General Regulatory Notes 1

51

Public Market (Governament)

Oncologies Products – Tenders/ Sell 2014 :

ByLadinaConsul.ng-Brazil

List : Product / Presentation / Quantities / Supplier and Values

53

Thankyou.

54 Mobil : +55 19 991614172