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December 2010
Disclaimer
Except for the historical information contained herein, statements in this presentation and the subsequent discussions, which include words or phrases such as will, aim, will likely result, would, believe, may, expect, will continue, anticipate, estimate, intend, plan, contemplate, seek to, future, objective, goal, likely, project, should, potential, will pursue and similar expressions or variations of such expressions may constitute "forward-looking statements". These forward-looking statements involve a number of risks, uncertainties and other factors that could cause actual results to differ materially from those suggested by the forward-looking statements. These risks and uncertainties include, but are not limited to our ability to successfully implement our strategy, our growth and expansion plans, obtain regulatory approvals, our provisioning policies, technological changes, investment and business income, cash flow projections, our exposure to market risks as well as other risks. Claris Lifesciences Limited does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date thereof.
Industry Overview
Industry Size
Claris is present in the injectables space - a lucrative market segment, given a much smaller number of competitors and hence high profitability margins
Source: CII-KPMG, Pharma Summit 2009, Avalon Global Research, The Global Generic Injectables Business, December 2009
715 648
773
700 560
605
500
300
2004
2005
2006
2007
2008
Number of companies
8 7 6 5 4 3 2 1 0 10 20 30 40 50 60 70
105
8% R1 80 CAG
92
90
62 55
USA and EU are the largest regulated markets for injectables, accounting for 90% of the regulated markets USA is the largest market for generic and non-biological injectables, accounting for about 51% of the global market, whereas emerging markets account for 20% of the global generics injectables market
26% 24%
Injectables is a specialized and niche area within the pharmaceuticals industry: High complexity involved in formulating a large and complex product portfolio across various therapeutics based on multiple technology platforms and multiple delivery mechanisms High capital intensity Governed by tougher regulations Customer segments are almost exclusively hospitals with distinct decision making process and criteria
Manufacturing facilities with sustainable cost leadership that meet the requirements of relevant regulatory agencies
800
773.2
30%
600 20% 400 14.6% 311.8 247.5 200 5.7% 6.4% 76.6 0 2.7% 7.7 India Global scale 6.6% 0% 10%
North America
Europe
Japan
Market size
CAGR (2003-08)
Source: Cygnus, Industry Insight Global Generics, March 2009)
Claris Overview
Claris commences business as a Trading Company in Blood Products Successfully penetrates the Indian hospitals market Creates the core team and support infrastructure Launches Speciality Products development programs Commences manufacturing project
Regulatory teams and manufacturing infrastructure in place Achieves leadership position in India International expansion in emerging markets Manufacturing facility approvals by ANVISA Brazil, INVIMA Colombia, MHRA UK and others Unveils strategy for regulated markets Carlyle invests Rs. 905.06 million in the Company for 13.89% stake
US FDA approval for sterile injectables manufacturing facility Emerges as a significant player in emerging markets Launch of a range of infusion products in non-PVC bags Commenced own sales and marketing activities in the US Scale up of product development and manufacturing facilities Commencement of Oncology vertical in India Received approval for four ANDAs in the United States Received letter from the USFDA in relation to the registration of our aseptic manufacturing line
Enhanced focus on regulated markets In-License ANDAs from companies that are looking to sell them and reduce the lead time to launch new products in the US Increase penetration in markets such as Russia and Turkey Regulatory filing for complex and high potential products such as Propofol and Iron Sucrose US FDA approval for Clarion IV and Clarion V
Claris has evolved from an Emerging Market focused injectables company to one of the leading pure play global injectables players
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Generic
Branded Generics
Patented Brand
APIs
Formulations
NDDS
Ointments
Injectables
Markets
Unregulated
Regulated markets
R&D
Discovery
Claris business focus is higher up in the value chain of the pharmaceutical industry in terms of Therapy & Drug Target Action, Formulation Stage, Delivery Systems & Market Focus
Claris Presence
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Broad product portfolio across therapeutic areas, technology platforms Capability to manufacture complex APIs for captive use
Manufacturing facilities, with sustainable cost leadership, that meet the requirements of relevant regulatory agencies
12
Company
Product Mix
Anesthesia, clinical nutrition, continence care, diabetes care, extracorporeal blood treatment, infection prevention, infusion therapy, neurosurgery, orthopaedics
N/A
N/A
Anesthesia, bio surgery, clinical nutrition, critical care, hemophila, immunoglobulin, infusuion systems / IV tubing, pharmaceuticals, solutions and drug delivery, pulmonology, renal, subcutaneous fluid administration, vaccines
28.7
12.5
Medication management systems, I.V. Sets, solutions & irrigation, drug delivery systems, in-patient glycemic control, pharmaceuticals, invasive monitoring systems, suction products
8.9
3.8
Hemodialysis, acute dialysis, peritoneal dialysis, dialysis care, spectra laboratories, liver support therapy, therapeutical apheresis
16.2
14.8
13
15
16
Manufacturing Infrastructure
5 manufacturing plants across a 78 acre campus Certain facilities have been approved by Foreign Regulatory Authorities including US FDA, MHRA(UK), TGA (Australia) & GCC FDCA One of the few manufacturers in India and other emerging markets to have facilities approved by multiple regulatory authorities in the regulated markets for: Large volume parenterals in glass bottles Emulsions manufacturing and Bag manufacturing (PVC & Non PVC)
Over 100 successful audits from regulatory authorities; WHO GMP, ISO 9001-2000 and regulatory compliance certifications Cost leadership These facilities have a significant cost advantage over the facilities set up by international competitors in North America or Western Europe Technologies purchased from international suppliers such as a double pass reverse osmosis system from Christ (Switzerland), distillation columns from Stillmas (Italy), manufacturing vessels from Diesel (Germany), glass vials washing and sterilization tunnels from Groninger (Germany), etc. Received Indian Drug Manufacturer Associations Quality Excellence Award and Frost and Sullivan award for manufacturing excellence
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Manufacturing Infrastructure
Clarion I Manufactures sterile injectable products 5 Manufacturing lines for: Glass Ampoules & Vials LVP in Glass Emulsion Manufacturing Non-PVC Bags PVC Bags Clarion II Manufactures Sterile Infusion Products Blow, Fill & Seal (BFS) Technology Equipped to manufacture products in various volumes in the IV fluids and antibiotic segments 6 LVP Lines and 1 CAPD bag line (Peritoneal dialysis) Clarion III Dedicated to manufacturing highly complex and difficult to source APIs meant solely for Captive Consumption 2 lines - iron sucrose and starches Clarion IV Same manufacturing lines as Clarion I for LVP More sophisticated & advanced equipment achieving higher manufacturing capacities A bag manufacturing line which can be used to produce Multi-Chamber bags
World class manufacturing facilities provide a long term sustainable competitive advantage
19
20
Sales team of approximately 422 people in India who supply mainly to hospitals Network of approximately 43 clearing and forwarding agents, 40 distributors, 16 consignee agents and 1,120 stockists in India Total sales force of about 107 people in the international markets Business arrangements with local companies in regulated markets to grow the distribution network and to strengthen the sales and marketing presence across 76 countries
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Board of Directors
Board of Directors
Post Graduate in Management from Northeastern University, Boston, USA and holds a Bachelor of Commerce degree from Gujarat University, Ahmedabad Appointed as Director of the Company on February 19, 2001 and has been the Managing Director & CEO since September 26, 2008 Holds a Bachelors degree in Commerce and Doctorate in finance from Mumbai University and also qualified & practicing Chartered Accountant and Cost and Works Accountant Appointed as a Director on April 27, 1999 Holds a Master of Business Administration degree from Babson College, Boston, USA and holds a Bachelor of Commerce degree from Gujarat University, Ahmedabad Appointed as a Director of the Company on June 13, 2006 and served as CFO of the Company from January 1, 2008 to March 31, 2009 Holds a Bachelor of Science degree from Saurashtra University, Rajkot Chetan Majumdar Executive Director Joined the Company on April 1, 1999 and has around 34 years of experience in the pharmaceutical industry Responsible for the technical aspects of the business Eminent & Experienced directors bring extensive knowledge and best practices, assisting in attaining higher levels
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Board of Directors
Holds a Master of Commerce degree from Maharaj Shivajirao University, Vadodara Appointed as an Executive Director in July , 2009, he has been with the company since April 1, 1999 Has around 13 years of experience in the pharmaceutical industry
Hold a Bachelor of Electronics and Communication degree from Gujarat University, Ahmedabad and holds MBA degree from Gujarat University Been with the Company since February 1, 2003 and has about 15 years of experience in the pharmaceutical industry Responsible for spearheading Companys foray in to the regulated markets Holds a Post-graduate degree in Mathematics and a Graduate degree in Law from Punjab University and has completed his training in Public Administration from the National Academy of Administration Served in the Indian Administrative Service for about 35 years Retired from Public Service as Chairman of the Board for Industrial and Financial Reconstruction
Eminent & Experienced directors bring extensive knowledge and best practices, assisting in attaining higher levels
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Board of Directors
Holds a Master of Science degree in Biomedical engineering from the Indian Institute of Technology, Chennai, and is a graduate in mechanical engineering from the Indian Institute of Technology, Chennai Has over 35 years of experience in manufacturing and consulting
Holds a Post-graduate diploma in management from Indian Institute of Management, Ahmedabad and B.Com (Hons) from the University of Delhi Nominee director of First Carlyle Ventures III
Management team includes senior executives, a majority of whom have worked with the Company for over five years Total Employee strength of 1,614 We have around 1,539 employees in India, out of which 75 employees worked for R&D and approximately 493 were post graduates and around 805 were graduates We employed around 75 foreign nationals in the country and around 1,841 contract labourers
Eminent & Experienced directors bring extensive knowledge and best practices, assisting in attaining higher levels
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Business Strategy
Business Strategy
Objectives
Establish and expand presence in key emerging markets
Strategies
Increase presence in emerging markets, such as Brazil, Mexico, South Korea and Saudi Arabia, as well as to establish presence in new emerging markets, such as China, Russia, Turkey Increasing the portfolio of product registrations and filings Increasing customer and distributor base through marketing arrangements with local pharmaceutical companies
Focus on increasing market share for certain key and high potential products
Certain key products such as propofol, iron sucrose and hydroxyl ethyl starch, ciprofloxacin and metronidazole have large markets worldwide
These products are manufactured in India only by a few companies, for the global markets To focus sales and marketing efforts on these product groups to capture larger market share Only company in India to produce UNIBAG non-PVC infusion system which are a preferred delivery system in regulated markets
Plans to expand Clarion manufacturing facilities in Ahmedabad, India These facilities are in a low-cost location as compared to the facilities set up by international competitors in North America or Western Europe
Focus is to ensure that company continues to maintain and grow margins and maintain its cost leadership in the generic injectables business
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Business Strategy
Objectives
Increase product range across existing and new technology platforms and delivery systems
Strategies
Filed 280 applications for product registrations in regulated markets, including 36 applications in the United States as of August 31, 2010 Intend to apply for additional approvals from the USFDA and other regulatory authorities for manufacturing facilities and products to increase product range Primarily targeting injectable products which have or are due to go off-patent in regulated markets Also initiated its foray into the oncology segment
Increase presence in regulated markets such as the United States, Western Europe, Australia, New Zealand, Canada and South Africa
Plans to establish business presence in Japan Further grow business in the US and other regulated markets by expanding the sales and distribution network through business arrangement with the Pfizer group
To get in license and other supply arrangements with companies that have an established presence in the relevant markets, to further increase presence
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Growth Drivers
Growth Drivers
Future Outlook: Global generic injectables are expected to grow rapidly and are estimated to reach USD 33 billion in size in 2014, up from USD 20 billion in 2009 This growth is driven by a large number of innovator injectable products going off-patent (both oncology and other therapies) in the non-biological segment and limited price erosion in these products, even after becoming generics, due to limited competition compared to oral dosage products Products generating revenues of USD 70 bn are expected to go off-patent in US in the next 3 years
2008E 2009E 2010E 2011E 2012E 20 20 Patent Expirations (USD bn) 28 28 27 2009 2014 20 Future Trends Global Generic Injectables
% R 10 CA G
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Source :- Datamonitor, Epsicom Business Intelligence, Avalon Global Research, The Global Generic Injectables Business, December 2009
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Financial Highlights
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Financial Highlights
Total Income (mn)
9,000 8,000 7,000 6,000 5,000 4,000 3,000 2,000 1,000 0 2005 2006 2007 2008 2009 31st May, 2010
4,027 2,924 6,238 3,379 7,639 7,594
EBITDA (mn)
% 27 AGR C
2,500 2,000 22% 1,500 1,000 500
390
56% CAGR
26%
28%
13%
1,620 881
2,101
2,295
15% 10%
1,031
5% 0%
PAT (mn)
1,400 1,200 1,000 800 600 400 200
185 508
ROE (%)
1% R6 CAG
16% 13% 14% 14% 17% 18% 16% 14% 12% 10%
ROCE (%)
26% 24% 30% 22% 27% 24% 24% 21% 28% 26% 24% 22% 20% 18% 16% 14% 12% 10%
35% 30% 25% 20% 15% 10% 2005 2006 19% 22%
18% 23%
6%
893
1,250 1,079
8% 6%
577
4% 2% 0%
2007
2008
ROE
2009
ROCE
* Annualised
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Thank you
BSE: CLARIS (533288) | BLOOMBERG: CLAR:IN | REUTERS: CLAIf.BO BSE: BLOOMBERG: REUTERS:
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