lupin limited corporate presentation august 2006
TRANSCRIPT
Lupin LimitedCorporate Presentation
August 2006
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
Contents Pg Nos
Introduction 4
Pharmaceutical Industry Overview 6
Approach 9
Advanced Markets 14
Other Emerging Markets 19
API & Intermediates 22
Research & Development 25
Business Update 29
Facilities 36
Management 38
And Beyond 40
4
Introduction . . .
Section 1Section 1
5
Vision
• To be an Innovation led Transnational Pharmaceutical Company
Values
• Superior Performance
• Entrepreneurship
• Customer Orientation
• Working Together
• Respect for People
• Integrity
Pharmaceutical Industry Overview
Section 2Section 2
7
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
8
Indian Pharma – Emerging Scenario
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
CONTRACT MANUFACTURING
• JV/ Alliances
• Competition from China
INDIGENOUS R&D
• ANDA/NDDS/NCE
• Out Licensing
• High Investment/ Long gestation
Indian Pharma
Domestic Market: US$ 5bn Exports: US$ 2.5bn Total: US$ 7.5bn
9
Approach
Section 3Section 3
10
Lupin Strives For
Sustainable Earnings
Accelerated Growth
Fulfilling Stakeholder Aspirations
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 Japan, Australia, Latin America
• TB Institutional
• Alliances with Global majors for certain markets
• New therapies (In-Licensing)
12
Regulated Markets (US): Lupin Approach
LUPINLUPIN
Generics Para III
Specialty
Para IV ComplexGenerics Branded
Generics
Lisinopril…
Ramipril…
Ceftriaxone...
NCE/
ND
DS
Suprax…
Other Regulated Markets:
• Focus on Branded Products
• Partnerships & Alliances
13
Developing Markets : Lupin Approach
Rural
IND
IA/ C
IS/ AA
ME
/ LA
SpecialtyPost 2005
In-licensing
Ceff-E
R, Odo
xil O
D, …
Lup
inov
aNDDS
LUPINLUPIN
Global Tenders
GTB
Enoxaparin Sodium…
Branded Generics
Urban
14
Advanced Markets
Section 4Section 4
15
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 Total ANDAs filed: over 40
16
Generics US
Target Therapies
Mkt size Lupin
$ billion No. of products
Launched till now
Cephalosporins 2 10 7
CVS 25 15 1
CNS 15 11 -
Anti-ulcer 13 4 -
Macrolides 2 2 -
Others 3 3 -
Total 60 45 8
17
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
18
Robust pipeline
Country Total submissions
US 41
EU 12
France 2
Australia/ NZ 11
RoW 1230
19
Other Emerging Markets
Section 5Section 5
20
India Region Formulations
• Growing at 23% vs 16% 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 (119%)
• 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
Odoxil 77 R-Cinex 101
AKT – 4 93 Cefaxone 41
Ceff 44 Tonact 96
AkuriT – 4 56 L-Cin* 49
Rablet 62 Ramistar 47
Rs. Mn ORG-MAT JAN 06*introduced in last 3 years
21
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%
22
API & Intermediates
Section 6Section 6
23
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
24
Global Position in API & Intermediates
1Cephalosporin -
Intermediate7ADCA
1CardiovascularLisinopril
2Cephalosporin -
Intermediate7ACCA
1Anti-TBPyrazinamide
1Anti-TBRifampicin
1Anti-TBEthambutol
Global Rank
Therapeutic SegmentProduct
Two new products in 2006-07
25
Research & Development
Section 7Section 7
26
R&D
• Over 350 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
27
R&D
• NCEs – Anti Psoriasis (Herbal) - In Phase II
– Anti Migraine - Nearing completion of Phase II
– Anti Psoriasis (Chemical) - In Phase II
– Anti TB - In Phase I
28
Patents
Patents Issued, Allowed & Pending302
Issued, Allowed 71
Pending231
US14
EU
RoW47
EU10
US31
EU18
RoW182
29
Business Update
Section 8Section 8
30
2005-06
6618
8896
5505
7714
12123
16610
02000400060008000
1000012000140001600018000
Domestic Exports Total
2004-05 2005-06
34% 40%
37%
(Rs
Mn)
Sales Growth
Fml Ind37%
Fml Reg13%
API SR10%
API Reg18%
API Ind17%
Fml SR5%
Revenue Composition
31
2005-06
• Revenue Growth : 37%
• EBITDA margin : 18%
• PBT : 14%
• PAT : 11%
• ROCE : 22%
844
18271458
3009
0
500
1000
1500
2000
2500
3000
3500
Net Profit EBITDA
2004-05 2005-06
106%(R
s M
n)
Profit Growth
116%
32
2004-05
Exports45%
Domestic55%
Geographical Coverage
Exports46%
Domestic54%
2005-06
33
Anti Diabetics3%
Anti Asthma3%
Cephs23%
NSAIDS3%
CVS13%
Anti TB33%
Others22%
Therapeutic Coverage
2004-05
2005-06
Anti Diabetics6%
Anti Asthma4%
Cephs19%
NSAIDS4%
CVS16%
Anti TB26%
Others25%
34
2004-05
FD45%
API55%
API vs FD
FD55%
API45%
2005-06
35
3655
4851
0
1000
2000
3000
4000
5000
6000
Sales
Q1 FY0506 Q1 FY0607
432
507
380
400
420
440
460
480
500
520
Net Income
Q1 FY0506 Q1 FY0607
2006-07 – Q1(R
s M
n)
33%
17%
(Rs
Mn)
36
Facilities
Section 9Section 9
37
Lupin’s Facilities
Manufacturing
Research Center
Goa
Pune
Tarapur
Ankleshwar
Mandideep
Aurangabad
JammuLOCATION 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,
J&K
Formulations -
Pune, Maharashtra
R&D
Mumbai,
Maharashtra
Head OfficeHead Office
Mumbai
38
Management
Section 10Section 10
39
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 KhannaGroup 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 DhawanPresident--Business Development
• Heads the AAMLA region, responsible for the development of Lupin’s 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 NarulaPresident Corporate Affairs
• Heads the company’s business initiatives in the CIS region • Supports the businesses through various Embassies and trade Associations
Nilesh Gupta Exec VP, IPMG• Responsible for driving product identification for the advanced markets identifying in-licensing and out-licensing
opportunities13
40
and Beyond . . .
Section 11Section 11
41
Going Forward with
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
42
Going Forward with
Explore New Therapies/ Business Segments
• Therapeutic Areas Oncology Dermatology
• Business Segments Biosimilars CRAMS
43
Thank you