Transcript Lupin Limited

LUPIN
Investor Presentation
May 2006
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.
Agenda
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Global Pharmaceutical Industry Overview
Indian Pharmaceutical Industry
Lupin -Business Update
2006-07 and Beyond
Lupin Limited
Vision
• To be an Innovation led Transnational
Pharmaceutical Company
Values
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Superior Performance
Entrepreneurship
Customer Orientation
Working Together
Respect for People
Integrity
Pharmaceutical Industry Overview
Global Pharmaceutical Industry Overview
 Global Pharmaceutical market at US$600 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 US$60bn is growing at 6%
 EU experiencing growth at 7% at US$ 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 R&D productivity has led to
limited new drug pipeline
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Indian Pharma – Emerging Scenario
Domestic Market: US$ 5bn
Exports: US$ 2.5bn
Total: US$ 7.5bn
CONTRACT MANUFACTURING
• JV/ Alliances
• Competition from China
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DOMESTIC FORMULATIONS
IPR Regime
Pricing pressure on ‘older’ molecules
Brands/ differentiated products
Likely to witness higher growth
In Licensing
Indian Pharma
INDIGENOUS R&D
• ANDA/NDDS/NCE
• Out Licensing
• High Investment/ Long gestation
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GENERICS BUSINESS
Increasing competitive landscape
Pricing pressure
Aggressive build up of products
Acquisitions
US$ 60 bn opportunity
Lupin Strives For:
Sustainable Earnings
Accelerated Growth
Fulfilling Stakeholder Aspirations
Regulated Markets (US): Lupin Approach
Para IV
Complex
Generics
Branded
Generics
Generics Para III
LUPIN
Other Regulated Markets:
• Focus on Branded Products
• Partnerships & Alliances
Specialty
Developing Markets : Lupin Approach
Branded Generics
Rural
Urban
Specialty
Post 2005
LUPIN
Advanced Markets
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 2005-06
 Timely launch of Ceftriaxone and Cefprozil immediately on expiry
 Launched Lisinopril in Dec05: Consolidating Market share
 Commenced Direct Marketing (DTM) in Dec05
 18 ANDAs filed taking total ANDAs to over 35
Generics US
Mkt size
Target Therapies
$ billion
Lupin
No. of products
Launched till now
Cephalosporins
2
10
7
CVS
25
15
1
CNS
15
11
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Anti-ulcer
13
4
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Macrolides
2
2
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Others
3
3
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Total
60
45
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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:
• JV with Aspen (Anti-TB FDC) for Africa
Robust pipeline
Country
Submissions
during the year
Total
submissions
US
18
37
EU
9
11
France
2
2
Australia/ NZ
9
11
346
1107
RoW
India Region
India Region Formulations
• Growing at 24% vs 8% industry average
Contributed by CVS (57%), NSAIDS (38%) and Diabetology (174%)
• Anti-Asthma range launched in Aug 04, already number 2 in its
segment and growing (126%)
• Signoflam (Endeavour), the best product launch (IMS Data) of the
year in the industry
• Lupinova driving foray into rural and less penetrated regions
• Top 10 brands
Odoxil
341
R-Cinex
316
AKT – 4
236
Cefaxone
185
Ceff
166
Tonact
148
AkuriT – 4
147
L-Cin*
127
R- Cin
121
Ramistar
119
*introduced in last 3 years
Rs. Mn ORG-MAT JAN 06
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%
API & Intermediates
API & Intermediates
• Sales : 11% growth
• Ceftriaxone launched in US
• Focus on Cost & Quality Leadership and
Reliability
• Long Term Supply Contracts
• Global Leadership in areas of therapeutic presence
• Future expansion only at SEZs
Global Position in API & Intermediates
Therapeutic Segment
Global
Rank
Ethambutol
Anti-TB
1
Rifampicin
Anti-TB
1
Product
Pyrazinamide
Anti-TB
1
7ACCA
Cephalosporin Intermediate
2
7ADCA
Cephalosporin Intermediate
1
Lisinopril
Cardiovascular
1
Two new products in 2006-07
Research & Development
R&D at Lupin
• Over 300 scientists
– Actively engaged in: Process Improvement/ Formulation
Development/NCE/ NDDS
• Expenditure: Rs.1030mn – 6.2% of Sales
– Continue investing incrementally
• Filings in last year
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US: ANDAs: 18
EU: MAAs: 11
ANZ: Dossiers: 9
Other: Dossiers: 346
DMFs/EDMFs/COS:41
• Going Forward
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NDDS
Paediatrics range
Patented Technology platforms
Products for paediatric pipeline
R&D at Lupin
• NCEs
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Anti Psoriasis (Herbal)
Anti Migraine
Anti Psoriasis (Chemical)
Anti TB
- In Phase II
- In Phase II
- Entering Phase II
- In Phase I
Patents
Patents Issued, Allowed & Pending
302
Issued, Allowed
71
US
14
EU
10
Pending
231
RoW
47
US
31
EU
18
EU
RoW
182
Business Update
2005-06
Sales Growth
18000
16000
14000
12000
10000
8000
6000
4000
2000
0
2004-05
2005-06
37%
16610
12123
34%
40%
8896
7714
6618
5505
Domestic
Exports
Revenue Composition
Total
API Reg
18%
API SR
10%
Fml Ind
37%
API Ind
17%
Fml Reg
13%
Fml SR
5%
2005-06
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Revenue Growth : 37%
EBITDA margin : 18%
PBT
: 14%
PAT
: 11%
ROCE
: 22%
Profit Growth
2004-05
2005-06
3500
3000
3009
2500
106%
2000
1827
1500
1458
116%
1000
844
500
0
Net Profit
EBITDA
Geographical Coverage
2004-05
Domestic
55%
2005-06
Exports
45%
Domestic
54%
Exports
46%
API vs FD
2004-05
API
55%
2005-06
FD
45%
API
45%
FD
55%
Lupin’s Facilities
LOCATION
PRODUCTS
APPROVALS
Mandideep,
Madhya
Pradesh
Cephalosporins
Prils
USFDA, UK MHRA, TGA
USFDA
Tarapur,
Maharashtra
Rifampicin
Lovastatin
USFDA, UK MHRA
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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
Noncephalosporin
Oral
Formulations
USFDA, UK MHRA
Manufacturing
Jammu,
J&K
Formulations
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Research Center
Pune,
Maharashtra
R&D
Mumbai,
Maharashtra
Head Office
Jammu
Mandideep
Ankleshwar
Tarapur
Mumbai
Aurangabad
Pune
Goa
Head Office
Year 2006-07 and Beyond
Lupin 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
Lupin Going Forward
Explore New Therapies/ Business Segments:
• Therapeutic Areas
 Oncology
 Dermatology
• Business Segments
 Biosimilars
 CRAMS
Thank you