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Lupin Limited

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Indian Pharma Emerging Scenario. DOMESTIC FORMULATIONS. IPR Regime ... President, Pharma research. Himadri Sen, Ph.D. Has driven Lupin's entry in the ... – PowerPoint PPT presentation

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Title: Lupin Limited


1
Lupin Limited Corporate Presentation
January 2007
2
Safe Harbour Statement
  • Materials and information provided during this
    presentation may contain forward-looking
    statements. These statements are based on
    current expectations, forecasts and assumptions
    that are subject to risks and uncertainties which
    could cause actual outcomes and results to differ
    materially from these statements.
  • Risks and uncertainties include general industry
    and market conditions, and general domestic and
    international economic conditions such as
    interest rate and currency exchange fluctuations.
    Risks and uncertainties particularly apply with
    respect to product-related forward-looking
    statements. Product risks and uncertainties
    include, but are not limited, to technological
    advances and patents attained by competitors,
    challenges inherent in new product development,
    including completion of clinical trials claims
    and concerns about product safety and efficacy
    obtaining regulatory approvals domestic and
    foreign healthcare reforms trends toward managed
    care and healthcare cost containment, and
    governmental laws and regulations affecting
    domestic and foreign operations.
  • Also, for products that are approved, there are
    manufacturing and marketing risks and
    uncertainties, which include, but are not
    limited, to inability to build production
    capacity to meet demand, unavailability of raw
    materials, and failure to gain market acceptance.
  • The Company disclaims any intention or obligation
    to update or revise any forward-looking
    statements whether as a result of new
    information, future events or otherwise.

3
Contents
  • Global Pharmaceutical Industry Overview
  • Indian Pharmaceutical Industry
  • Lupin -Business Update
  • 2006-07 and Beyond

4
Introduction . . .
Section 1
5
Vision
  • To be an Innovation led Transnational
    Pharmaceutical Company

Values
  • Superior Performance
  • Entrepreneurship
  • Customer Orientation
  • Working Together
  • Respect for People
  • Integrity

6
Pharmaceutical Industry Overview
Section 2
7
Global Pharmaceutical Industry Overview
  • Global Pharmaceutical market at US600 billion
    market in 2005
  • Market expected to grow at a rate of 6-7
  • Ten major markets account for almost 81 of the
    market in terms of revenue
  • North America is the single largest market
    accounting for approx. 50 of global sales and is
    expected to grow at a CAGR of 5-8
  • Japan, the second largest market, at US60bn is
    growing at 6
  • EU experiencing growth at 7 at US 170bn
  • Growing importance of generics in regulated
    markets
  • Pressure from healthcare providers and insurance
    companies to reduce healthcare costs driving
    usage of generic drugs
  • Increasing patent expirations driving generic
    drug availability
  • Stringent testing requirements and declining RD
    productivity has led to limited new drug pipeline

8
Indian Pharma Emerging Scenario
Domestic Market US 5bn Exports US
2.5bn Total US 7.5bn
CONTRACT MANUFACTURING JV/ Alliances Competition from China
Indian Pharma
DOMESTIC FORMULATIONS IPR Regime Pricing pressure on older molecules Brands/ differentiated products Likely to witness higher growth In Licensing
GENERICS BUSINESS Increasing competitive landscape Pricing pressure Aggressive build up of products Acquisitions US 60 bn opportunity
INDIGENOUS RD ANDA/NDDS/NCE Out Licensing High Investment/ Long gestation
9
Section 3
Approach
10
Lupin Strives For
11
Creating an Edge
  • Technology
  • New Delivery Systems
  • Complex Products
  • Bottom Quartile of costs for generic products
  • Integration
  • NCE
  • Markets
  • Expansion Efficiency in Sales Force
  • Direct to Market approach in US
  • Build on Paediatric
  • On-shore presence in 5 select countries
  • Alliances
  • Partnerships in Advanced as well as Emerging
    markets
  • TB Institutional
  • Alliances with Global majors for certain markets
  • New therapies (In-Licensing)

12
Advanced Markets
Section 4
13
Advanced Markets Lupin Approach
14
US
  • Branded
  • Suprax continues its prescription growth over
    5000Rx per week
  • Sales force internalised
  • Copromotion of Atopiclair with Chester Valley
  • New Products in 2006-07
  • Generics
  • 7 products launched in the US in FY06 3 launched
    till date in FY07
  • Timely launch of Ceftriaxone and Cefprozil
    immediately on expiry
  • Launched Lisinopril in Dec05 Consolidating
    Market share
  • Commenced Direct Marketing (DTM) in Dec05
  • Total ANDAs filed 45

15
Generics US
Target Therapies Mkt size Lupin Lupin
Target Therapies billion No. of products Launched till now
Cephalosporins 2 10 7
CVS 25 15 2
CNS 15 11 -
Anti-ulcer 13 4 -
Macrolides 2 2 -
Others 3 3 1
Total 60 45 10
16
Other Markets
  • Europe
  • Ramping up MAA/ Dossier filings
  • Alliances in progress
  • Revenues commenced
  • Expressions of interest at advanced stages
  • Japan, Australia LA
  • Expressions of interest moving forward
  • MDR-TB sales commenced in LA
  • South Africa
  • Aspen (Anti-TB FDC) for Africa

17
Robust pipeline
Country Total submissions
US 45
EU 29
Australia/ NZ 14
18
Emerging Markets
Section 5
19
Emerging Markets India Region - Lupin Approach
Institutional

Rural
Branded Generics
Urban
Specialty Post 2005
NDDS
In-licensing
Lupinova
LEP
Ceff-ER, Odoxil OD,
Enoxaparin Sodium, EGF,
LUPIN
20
India Region
  • 27 in 9mon FY07(16 Industry IMS Nov 06 MAT)
  • Growth 23 vs 7-8 industry average (FY 06)
  • Contributed by CVS(41), and GI (38)
  • Anti-Asthma range launched in Aug 04, already
    number 2 in its segment and growing (91)
  • Signoflam (Endeavour), the best product launch
    (IMS Data) of the year 2005 in the industry
  • Lupinova driving foray into rural and less
    penetrated regions
  • Top 10 brands

Tonact 304 R-Cinex 282
AKT 251 Odoxil 193
Rablet 185 L-Cin 158
AkuriT 150 Ceff 164
Ramistar 149 Cefaxone 124
Rs. Mn. YTD Dec 06
introduced in last 3 years
21
India Region
  • Divisions
  • Anti-TB, Anti-Infectives, Critical Care
    Speciality, CVS, Diabetology, CNS, Rural
    Marketing
  • Distribution Network
  • Nationwide spread with over 25 CFAs
  • Three centrally located warehouses
  • Covering over 2500 Stockists nationwide
  • Doctor Universe coverage
  • Over 130,000
  • Field Force Strength
  • Current strength of about 1800
  • Expanding to cater to newer therapy areas
  • Inlicensing introductions in FY07
  • Enoxaparin Sodium
  • IMS Nov 06, Gross sales for the month over Re. 1
    crore
  • Epidermal Growth Factor

22
Emerging Markets Others - Lupin Approach
Institutional

Generics
Branded Generics
Alliances
Specialty
NDDS
Alliances/ Licensing
GTB
CIS/ SEA/ ME/ Africa
LATAM
LUPIN
23
Other Markets
  • CIS
  • Posted a healthy growth CAGR of 44 over last 4
    years
  • Expanding Field Force
  • Russia, Ukraine, Azerbaijan, Kazakhstan,
    Uzbekistan
  • Increased market penetration
  • Around 20 Products Registered in each around 10
    under Registration
  • SE Asia
  • Alliance with GSK
  • Middle East
  • Will be shared as Alliances progress
  • Africa
  • Alliance with Ranbaxy
  • GTB
  • Posted a healthy growth 122

24
API Intermediates
Section 6
25
API Intermediates
  • Sales 11 growth 13 in H1 FY07
  • Focus on Cost Quality Leadership and
    Reliability
  • Long Term Supply Contracts
  • Global Leadership in areas of therapeutic
    presence
  • Future expansion only at SEZs

26
Global Position in API Intermediates
Global Rank
Therapeutic Segment
Product
1
Anti-TB
Ethambutol
1
Anti-TB
Rifampicin
1
Anti-TB
Pyrazinamide
2
Cephalosporin - Intermediate
7ACCA
1
Cephalosporin - Intermediate
7ADCA
1
Cardiovascular
Lisinopril
Two new products in 2006-07
27
Research Development
Section 7
28
RD
  • Over 400 scientists
  • Actively engaged in Process Improvement/
    Formulation Development/NCE/ NDDS
  • Expenditure (FY0506) Rs.1030mn 6.2 of Sales
  • Continue investing incrementally
  • Filings rate to continue
  • Going Forward
  • NDDS
  • Paediatrics range
  • Patented Technology platforms
  • Products for paediatric pipeline

29
RD
  • NCEs
  • Anti Migraine - In Phase III
  • Anti Psoriasis (Chemical) - In Phase II
  • Anti Psoriasis (Herbal) - In Phase II
  • Anti TB - In Phase I

30
Patents
Patents Issued, Allowed Pending 406
Issued, Allowed 71
Pending 335
US 14
RoW 47
EU 10
US 31
EU 44
RoW 260
EU
31
Business Update
Section 8
32
2005-06
Sales Growth
37
(Rs Mn)
34
40
Revenue Composition
33
2005-06
  • Revenue Growth 37
  • EBITDA margin 18
  • PBT 14
  • PAT 11
  • ROCE 22

Profit Growth
106
(Rs Mn)
116
34
Geographical Coverage
2004-05
Domestic
55
2005-06
Exports
45
35
Therapeutic Coverage
36
API vs FD
2004-05
API
2005-06
55
FD
45
37
2006-07 9 month period ended Dec 06
(Rs Mn)
22
(Rs Mn)
25
38
Section 9
Facilities
39
Lupins Facilities
LOCATION PRODUCTS APPROVALS
Mandideep, Madhya Pradesh Cephalosporins Prils USFDA, UK MHRA, TGA USFDA
Tarapur, Maharashtra Rifampicin Lovastatin USFDA, UK MHRA -
Ankleshwar, Gujarat Ethambutol Intermediates USFDA USFDA
Aurangabad, Maharashtra Rifampicin Pyrazinamide Ethambutol Lisinopril WHO, MCC (South Africa) WHO, MCC (South Africa) WHO, MCC (South Africa) WHO, MCC (South Africa)
Verna, Goa Non-cephalosporin Oral Formulations USFDA, UK MHRA
Jammu, JK Formulations -
Pune, Maharashtra RD
Mumbai, Maharashtra Head Office
Jammu
Tarapur
Mumbai
Pune
Goa
Manufacturing
Research Center
Head Office
40
Section 10
Management
41
Expert Management Team
NAME POSITION BRIEF PROFILE
Desh Bandhu Gupta, Ph.D Chairman Founded the company in 1968 Started his career teaching chemistry at Birla Institute of Science and Technology, Pilani, Rajashthan
Kamal K Sharma, Ph.D Managing Director Experience of more than three decades at a range of senior management positions managing projects, corporate development and general management in the pharmaceuticals and chemicals industries
Satish Khanna Group President, API Strengthened Lupin's API business and secured the company's position among top manufacturers, globally Rich experience of more than 25 years in leading companies including Mitsu Industries, Tata Chemicals and Union Carbide
Vinita Gupta President, Lupin Pharmaceuticals Inc, US Leads Lupin's foray in the advanced markets of the US and Europe and in cementing alliances with global majors
Himadri Sen, Ph.D President, Pharma research Spearheads Lupin's drive for NDDS, ANDA and patent fillings Has worked with leading Indian and global pharma companies in the areas of pharma research, technology development and transfer and manufacturing support
Shakti Chakraborty President, India Region Formulations Has driven Lupin's entry in the lifestyle segments Experience of more than three decades with leading pharmaceutical companies like Wockhardt, Aristo Pharma
Vinod Dhawan President--Business Development Heads the AAMLA region, responsible for the development of Lupins business strategy for these markets. Has worked with Ranbaxy in their international business
Indrajit Banerjee President, Finance Planning Responsible for the finance, IT and planning functions and aligning it with overall business strategy of the company
Rajan Dutta President, Human Resources Responsible for developing HR management strategy and align it with overall business strategy of the company Brings along with him rich business experience of about 2 decades in organizations like Xerox, Idea, Bharti Airtel, etc
Harish Narula President Corporate Affairs Heads the companys business initiatives in the CIS region Supports the businesses through various Embassies and trade Associations
Nilesh Gupta President, Advanced Markets Responsible for Product Pipeline management, Intellectual Property Strategy, RD integration, Supply Chain and New Projects for Advanced Markets
13
42
Year 2006-07 and Beyond . . .
Section 11
43
Going Forward
  • New Markets/ Initiatives
  • Enter Advanced Markets
  • EU
  • Japan
  • Australia
  • South Africa
  • Establish On-shore presence in 5 select markets
  • Acquisition
  • Brands in US
  • Businesses in select countries of EU
  • Domestic
  • Explore New Therapies/ Business Segments

44
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