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Ipca

Greetings from Ipca

Ipca Laboratories Limited Partnering Healthcare Globally September - 2006

Company Overview Incorporation

1949

Present Management since

1975

Turnover in 1975

Rs. 5.00 Mn. USD 0.11 Mn.

Ipca

Total Turnover F.Y. 2005-06

Rs. 7533 Mn. USD 167 Mn.

Exports F.Y. 2005-06

Rs. 4018 Mn. USD 89 Mn.

Number of Employees

(Over 4,500)

Business Model

Fully integrated pharmaceutical company producing Generics & Branded Formulations, Intermediates & APIs 2 of 47

Revenue break-up F.Y. 2005-06 - Rs.7533 Mn. (USD 167 Mn.) Formulations

APIs / Intermediates

Ipca

Rs. 5013 Mn. (USD 111 Mn.)

Rs. 2477 Mn. (USD 55 Mn.)

International

International

Rs. 2100 Mn. (USD 46 Mn.)

Rs. 1918 Mn. (USD 43 Mn.)

Domestic Rs. 2913 Mn. (USD 65 Mn.)

Others

Rs. 43 Mn. (USD 0.95 Mn.)

Domestic

Rs. 559 Mn. (USD 12 Mn.)

3 of 47

Formulations & API share Formulations 66%

APIs / Intermediates 34%

Ipca

Based on 2005-06 turnover of Rs. 7533 Mn. (USD 167 Mn.) 4 of 47

Ipca

Manufacturing Facilities

5 of 47

Formulations Location

Dosage Form

Approvals / Inspections

Athal (Silvassa)

Tablets & Capsules Capacity – 8 billion tablets p.a.

UK-MHRA, TGA-Australia, MCCS.Africa, ANVISA – Brazil

Ratlam (M.P.)

Tablets & Liquids

MCC-S.Africa

Kandla (Gujarat)

Betalactum – Tablets, Capsules & Dry Syrups.

UK- MHRA, TGA – Australia, MCC – South Africa, ANVISA – Brazil

Danudyog Estate (Silvassa)

Tablets

Dehradun (H.P.)

Tablets

Ipca

Production Commenced in

APIs & Intermediates Ratlam (M.P.)

Various APIs & Intermediates Capacity – 1505 MT p.a.

Indore (M.P.)

Various APIs & Intermediates Capacity – 932 MT p.a.

Aurangabad (Mah.)

Various Intermediates Capacity – 600 MT p.a.

May-2006

US – FDA TGA – Australia

6 of 47

Ipca

Domestic Marketing

7 of 47

Domestic Marketing Profile 

All India Rank ORG-IMS : 23 (MAT Aug‘06).



20 Depots , 2 C&F agents & 2 Super Stockiest across India.



7 Marketing Divisions.



Detail Persons (MRs) -1514



Over 1500 Wholesalers.



4 brands among top 300 brands (MAT Aug’06)



Sales of price-controlled products - 16% (52% - 7 years back).

Ipca

8 of 47

MAJOR BRANDS with Sales > USD 1 mn. (ORG-IMS Aug’06)

Brand Name Therapeutic Group Lariago Perinorm Tenolol Zerodol Tenoric Glycinorm HCQS Rapither Eltocin Keftragard Malirid Larither Pacimol Sultax

Antimalarial Gastro-intestinal Cardiovascular Pain Management Cardiovascular Antidiabetic Pain Management Antimalarial Anti-Bacterials Anti-Bacterials Anti-Malarials Antimalarial Pain Management(NSAID) Antibacterial

Brand Size Rs. Mn. USD Mn. 422 173 145 208 149 150 114 83 79 78 72 65 60 54

9.3 3.8 3.2 4.6 3.3 3.3 2.5 1.8 1.7 1.7 1.6 1.4 1.3 1.2

Ipca

Above brands account for 54% of Domestic Formulations Sales Above Includes Brand Extensions

9 of 47

Contribution of Therapeutic Groups (ORG – IMS March’06)

MATMarch’06 Value (Rs.Mln.)

Ipca

Therapeutic Group Cardiovascular + Diabetology Antimalarial Antibacterial Pain Management Gastro-intestinal CNS+Dermatalogy Cough & Cold Others Total

871 664 507 466 261 205 109 73 3156

MAT-Mar’06 % Contribution 28% 21% 16% 15% 8% 7% 3% 2% 100% 10 of 47

Domestic Marketing Divisions General Pharma Product Range

3C

General CardiacPractitioners Diabetic

Innova

Intima

Activa

Hycare

CNS & Derma

Mature Brand s

Pain & GI

CardiacDiabetic

Ipca

Year Launched

1976

1997

2001

2002

2003

2004

Medical Rep. Force

432

217

213

319

181

152

Brands (Nos)

22

17

23

26

10

9

Sales 05-06 in Rs.Mn. / (USD Mn.)

1003 (22)

450 (10)

191 (4)

947 (21)

240 (5)

82 (2)

Growth–12mth

31%

31%

52%

37%

79%

68%

Note : The above sales are primary sales. 11 of 47

Growth – Ipca vs Industry (ORG-IMS Aug’06)

MAT Sept'05 Oct'05 Nov'05 Dec'05 Jan'06 Feb'06 Mar'06 Apr'06 May'06 June'06 July'06 Aug'06

Ipca

Industry

31.60% 16.10% 16.80% 16.60% 18.00% 19.90% 25.30% 23.70% 23.50% 22.70% 24.50% 16.00%

9.80% 7.40% 8.20% 8.60% 9.50% 10.90% 15.60% 15.60% 16.20% 15.80% 16.90% 13.30%

Ipca

12 of 47

New Product Sales Value Value % (USD Mn.) (Rs. Mn.) Contribution

Ipca

Products Launched in 2003–04

6.03

272

9%

Products Launched in 2004-05

7.47

336

12%

Products Launched in 2005-06

2.36

106

4%

Sub Total – New products

15.86

714

25%

Products Launched before 2003

48.87

2199

75%

Net Domestic Formulation Sales in 2005-06

64.73

2913

100%

Note : The above sales are primary sales. 13 of 47

Ipca

International Marketing

14 of 47

Highlights 

Exports to over 100 countries.



Recognised Trading House.



9th largest pharma exporter from India.

Ipca

(Source : Economic Times)



54% of sales is from exports.



Subsidiaries in USA, UK, South Africa, Nigeria & Brazil.



Marketing offices in Russia, Kazakhastan, Ukraine, Vietnam, Philipines, Kenya & Sri Lanka 15 of 47

Highlights contd….. 

Field-force to promote brands in Cambodia, Kazakhastan, Kenya, Mauritius, Myanmar, Oman, Russia, Sri Lanka, Sudan, Uganda, Ukraine, Vietnam & Yemen.



Formulations Dossiers registered / under registration in 68 countries.



Life Time Achievement Award from Chemexcil in 2004 for export performance.

Ipca

16 of 47

Continent-wise Exports 2005-06 Rs. In Crs

Continent EUROPE

Year 2005-06 2004-05 AFRICA 2005-06 2004-05 ASIA 2005-06 2004-05 CIS 2005-06 2004-05 AMERICAS 2005-06 2004-05 AUSTRALASIA 2005-06 2004-05 Total 2005-06 Total 2004-05

Formulations 84.29 139.61 51.18 33.19 10.26 10.73 56.40 44.06 4.25 4.14 3.60 4.71 209.98 236.44

Bulk drugs/ Intermediates 90.11 81.04 11.57 7.78 39.41 30.24 1.05 0.73 42.54 48.05 7.17 6.30 191.85 174.14

Total 174.40 220.65 62.75 40.97 49.67 40.97 57.45 44.79 46.79 52.19 10.77 11.01 401.83 410.58

Ipca

Growth over P.Y. -21% 53% 21% 28% -10% -2% -2%

Cont.% 43% 54% 16% 10% 12% 10% 14% 11% 12% 13% 3% 3% 100% 100%

17 of 47

International Business (USD Mn.)

4500

Rs. Mn.

4000

2500

(89)

4106

4018

3575

Ipca (62)

3500 3000

(82)

(94)

(52) 2313

2000 1500

2780

1000 500 01-02

02-03

03-04

04-05

05-06 18 of 47

Ipca

International Formulations Business

19 of 47

    Formulations Exports 2500

Growth % (USD Mn.) Rs.Mn.)

30% (47) 2067

-11% (46) 2100

33% (37) 1595

2000

(27) 1500

14% (54) 2364

1195

1000

Ipca

500

0 01-02

02-03

03-04

04-05

05-06

20 of 47

Ipca

International API Business

21 of 47



Focus on submission of Drug Master Files in USA & Europe.



69% of API sales from USA & Europe.



Strong API pipeline.



One of the largest manufacturer of APIs Atenolol, Propranolol, Chloroquine, Amodiaquine, Artemisinin derivatives, Pyrantel Salts, Frusemide, Hydroxychloroquine Sulphate.

Ipca

22 of 47

    API Exports 2000

1500

Growth % (USD Mn.) Rs.Mn.)

(26) 1118

1000

27% (35) 1507

6% (27) 1186

15% (40) 1741

10% (43) 1918

Ipca

500

0 01-02

02-03

03-04

04-05

05-06

23 of 47

Drug Master Files Sr. No.

US FDA

1

Atenolol

2

Trimethoprim

3

Pyrantel Pamoate

4

Furosemide

5

Metoclopramide HCl

6

Hydroxychloroquine Sulphate

7

Flumequine

8

Chloroquine Phosphate

9

Triclosan

UK MHRA

Canada HPFB

Australia

EDQM

5

11

Ipca

10

Pyrantel Tartrate

11

Propranolol HCl

12

Metoprolol Tartrate

13

Hydrochlorothiazide

14

Losartan Potassium

15

Metoprolol Succinate

16

Probenecid

17

Pentoxyfylline

18

Nabumetone

19

Balsalazide Disodium Dihydrate

20

Chlorthalidone

21

Lisinopril

22

Metformin

23

Mesalamine T otal

22

8

4

24 of 47

Ipca

International Business Strategy

25 of 47

Branded Promotional Markets 

Aggressive Brand promotion in the S-E. Asia, CIS & African markets.



Improve reach / penetration.



Aggressive product registration.

Ipca

- Dossiers registered : 851 - Under registration : 1456 

Field-force expansion Continent CIS S-E. Asia Africa

Field-force Current Planned Strength Strength 198 250 76 90 78 90

26 of 47

Developed Generics Market United Kingdom  68% generic sales to developed markets is from U.K.

Ipca

 Subsidiary incorporated in U.K. for Dossier filings.  75 product dossiers targeted for registration in U.K. -

Approved Submitted Cleared by R&D Under development

- 14 - 21 - 15 - 25

 Marketing through Distributors.

27 of 47

Other European countries 

Product dossiers registration work initiated in Hungary & Portugal.



Subsidiary Office opened in Portugal.



Marketing through Distributors.

Ipca

28 of 47

Australia & New Zealand PRODUCT DOSSIERS Registered Submitted TOTAL

5

NEW ZEALAND 2

--

17

5

19

AUSTRALIA

Ipca

Marketing is done through distributors.

29 of 47

Developed Generics Market

Country U.K. Europe (excl. U.K.) South Africa New Zealand / Australia Total

2004-05 2005-06 Sales Sales Growth (USD Mn.) (USD Mn.)

Ipca 25.57

14.92

-42%

3.91

3.81

-3%

2.37

2.46

4%

1.08

0.80

-26%

32.93

21.99

-33% 30 of 47

United States / Canada – Generics Market 

20 products identified for development and ANDA filing in a phased manner.



Most ANDAs to be backed by own APIs.



Marketing partner identified and agreement signed on profit-sharing basis.

 

5 ANDAs filed. Another 4 ANDAs are in Pipeline which are targeted by March, 2007.

Ipca

31 of 47

International Business - APIs  Contract manufacturing/ outsourcing arrangements with MNCs.

Ipca

 DMF filings :

 50 DMFs filed (for 23 APIs)

32 of 47

International Business - APIs  APIs development focussed towards non-infringing processes.

Ipca

 Non-infringing process patents filed for APIs currently under patent : Losartan Potassium

Metoprolol Succinate

Clopidogrel – Polymorph 1 Perindopril

33 of 47

Ipca

Domestic Business Strategy

34 of 47

Domestic Formulations Business  Therapy-focussed marketing divisions.  Brand Acquisition. Recently acquired Cardiac Brand “Isordil” from an MNC for India / Nepal Market.

Ipca

 Identified product pipeline for next 2 years.  Undertaking clinical research to introduce novel combinations / NDDS, and new indication approval.  3 clinical trials in progress in India  3 products CT permission applied  Open to co-marketing arrangements. 35 of 47

Ipca

Research & Development (APIs & Formulations)

36 of 47

Research & Development  Current scientist manpower of over 200.  Research focus on developing APIs with noninfringing process and development of finished dosage forms.

Ipca

 Development of NDDS for domestic market.  95 patent applications filed.

 5 Patent applications granted (Indian – 4, US PTO 1)

37 of 47

Research & Development R & D Spending Year 2001 – 02

Rs. Million

Ipca USD Mn.

% to Sales

82.63

1.89

2.06%

129.80

2.97

2.80%

248.40

5.71

4.12%

2004 – 05

335.90

7.46

4.97%

2005 – 06

378.60

8.41

5.05%

2002 – 03 2003 – 04

38 of 47

Major Player In Malaria Therapy 

Largest producer of Chloroquine & Amodiaquine.



40% share of antimalarial market in India .



First company to launch oral Artemether and Beta-arteether in India.



Recently launched artesunate-based combination therapy (ACT) in Nigeria , Kenya, Uganda & Burundi. Launches planned in Tanzania, Zimbabwe, Sudan & Rwanda.



WHO approved plants to manufacture Artesunate ACTs & other Antimalarials to UNICEF.

Ipca

39 of 47

Malaria – Global Scenario 

Malaria remains the world’s most devastating human parasitic infection, afflicting more than 500 million people and causing from 1.7 million to 2.5 million deaths each year.

Ipca

(World Health Organisation, 1997)

 

Remains a major health and economic burden in most tropical countries. Major cause of death equal with HIV/AIDS and tuberculosis. (Drugs 2002:62(9):1315-1329)

40 of 47

Current Status Of Malaria Therapy 

Spread and intensification of resistance.



Currently, Artemisinin based combination therapy – the only effective remedy.

Ipca

41 of 47

Ipca’s Initiatives in Malaria 

In-licensing agreement with CDRI to further develop synthetic trioxane as an alternative to Artemisinin (CDRI compound 97 / 78).



Collaboration with CDRI under DST (Department of Science and Technology) funding for research in derivatives of Artemisinin having enhanced activity.



In-licensing agreement with CIMAP for Artemisia annua Agri-technology.

Ipca

42 of 47

The Way Forward – Up the value chain Research & Product Development EU Dossiers/ANDA filings

NDDS

Manufacturing Formulations

Generics - Developed Mkts

Ipca APIs

Process Research

Marketing

Intermediates

Promotional Brands - Exports

Domestic Formulations.

KEY MANAGEMENT FOCUS R&D allocation being stepped up to 5%

• Addition of Internationally approved plants. • New formulation project planned at SEZ Indore for U.S. market.

Aggressive marketing & product range expansion. 43 of 47

Financials Particulars

2003-04 Value (Rs. Crs.)

Total Sales & Income PBIDT PBIDT % PBT PBT % PAT PAT %

2004-05

% Growth

Value (Rs. Crs.)

2005-06

% Growth

Ipca

Value (Rs. Crs.)

% Growth

622.74

29%

685.45

10%

753.30

10%

128.53

33%

131.49

2%

117.09

-11%

21%

108.01

19%

36%

17% 79.26 13%

101.55

-6%

15% 28%

80.71 12%

16% 78.39

-23%

10% 2%

63.98

-21%

8%

44 of 47

Financials Particulars

Quarter II July'06- Sept'06 Value (Rs. Crs.)

Total Sales & Income PBIDT PBIDT % PBT PBT % PAT PAT %

% Growth

1st Half Ended Sept'06 Value (Rs. Crs.)

Ipca

% Growth

244.48

24%

466.66

16%

58.59

72%

100.27

29%

24%

45.54

79%

19% 35.40 14%

21% 75.48

25%

16% 102%

59.74

38%

13% 45 of 47

Distribution of Shareholding (June 06)

Banks/ MFs/FIIs/FIs 27.97%

Ipca

Promoters 51.84%

Others 20.19%

46 of 47

Ipca 47 of 47

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