investor presentation may 2006 lupin. safe harbour statement materials and information provided...
TRANSCRIPT
Safe Harbour StatementMaterials 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
– Global Pharmaceutical Industry Overview
– Indian Pharmaceutical Industry
– Lupin -Business Update
– 2006-07 and Beyond
Vision
• To be an Innovation led Transnational Pharmaceutical Company
Values
• Superior Performance
• Entrepreneurship
• Customer Orientation
• Working Together
• Respect for People
• Integrity
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
4
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
Regulated Markets (US): Lupin Approach
LUPIN
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
Developing Markets : Lupin Approach
Rural
IRF/ C
IS/ AA
ME
/ LA
SpecialtyPost 2005
In-licensing
Ceff-E
R, Odo
xil O
D, …
Lup
inov
aNDDS
LUPIN
Global Tenders
GTB
Enoxaparin Sodium…
Branded Generics
Urban
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
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
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
RoW 346 1107
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
Rs. Mn ORG-MAT JAN 06*introduced in last 3 years
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
• 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
1Cephalosporin -
Intermediate7ADCA
1CardiovascularLisinopril
2Cephalosporin -
Intermediate7ACCA
1Anti-TBPyrazinamide
1Anti-TBRifampicin
1Anti-TBEthambutol
Global Rank
Therapeutic SegmentProduct
Two new products in 2006-07
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– US: ANDAs: 18– EU: MAAs: 11– ANZ: Dossiers: 9– Other: Dossiers: 346– DMFs/EDMFs/COS:41
• Going Forward– NDDS– Paediatrics range– Patented Technology platforms– Products for paediatric pipeline
R&D at Lupin
• NCEs – Anti Psoriasis (Herbal) - In Phase II
– Anti Migraine - In Phase II
– Anti Psoriasis (Chemical) - Entering Phase II
– Anti TB - In Phase I
Patents
Patents Issued, Allowed & Pending302
Issued, Allowed 71
Pending231
US14
EU
RoW47
EU10
US31
EU18
RoW182
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
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%
Lupin’s Facilities
Manufacturing
Research Center
Goa
Pune
Tarapur
Ankleshwar
Mandideep
Aurangabad
Jammu
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,
J&K
Formulations -
Pune, Maharashtra
R&D
Mumbai,
Maharashtra
Head OfficeHead Office
Mumbai
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