2014 IR PPT Claris Life Science
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Transcript of 2014 IR PPT Claris Life Science
Our endeavour is to help preserveEarth’s most precious resource...
Human Lives
Investor Relations Presentation2014
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, performance or achievements, to differ materially from those projected 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 can not guarantee that the mentioned assumptions and expectations are accurate or will be
realized; and also does not undertake any obligation to update forward-looking statements to reflect events or
circumstances after the date thereof..
28th February 2014 2Claris Lifesciences Limited
Company at a Glance
► One of the largest Indian sterile injectables pharmaceuticalcompanies
► Diversified revenue base across a range of products offerings soldin a number of countries in regulated as well as emerging markets
► Products range across various therapeutic segments, includinganesthesia, critical care, renal care, and nutrition
► In-house development and regulatory capabilities with over1000+ product registrations filings worldwide
► Market presence across 84 countries worldwide, includingregulated markets of US and Europe
► Established sales, marketing and distribution network throughdistributors & subsidiaries
► Manufacturing facility at a campus located in Ahmedabad, Indiawith approval from key global regulatory agencies
► Strong financial profile with significant growth potential, best-in-class profitability margins and stable cash-flow profile
28th February 2014 3Claris Lifesciences Limited
State of the Art Manufacturing Facilities
28th February 2014 Claris Lifesciences Limited 4
Overview
►Manufacturing facility at a campus located in Ahmedabad, India
►Approved by key global regulatory agencies
►Capabilities in successfully bringing laboratory batches to full production scale.
►One of the largest non-PVC/PVC bag and emulsion products manufacturing capacity in India
►Current capacity of ~100 million units, expected to increase threefold by 2015 with the start of new manufacturing facility
►Manufacturing facilities are ISO 9001-2000 and WHO GMP certified
Ahmedabad
Existing Facility
► Used for manufacturing of sterile injectable products
► Five separate manufacturing lines for glass ampoules and vials line, large volume parentals in glass, emulsion manufacturing, non-PVC Bags and PVC bags
Manufacturing Units
New Facility
► Plans to expand manufacturing facilities to develop capabilities in aseptic injectables products, in both liquid and lyophilised forms
► New manufacturing facility is expected to be operational by Q4 2014
Diversified Technologies & Delivery Systems
28th February 2014 Claris Lifesciences Limited 5
Delivery Systems
► Glass Ampoules
► Glass Vials
► Glass Bottles
► PVC/Non-PVC Bags
Technological Capabilities
► Emulsion Technology
► Aqueous Technology
─ SVP
─ LVP
► Form-Fill-Seal Technology
─ Non-PVC Bags
► Lyophilised
► Aseptic
Development capabilitiesOverview
►A team of 36 personnel employed in formulation development and analytical development labs
►R&D facilities approved by Department of Science & Technology, Government of India
►One of the few companies in the world to develop APIs like Hydroxyethyl Starch and Iron Sucrose
►Pioneer in bag and fat emulsion technology
Regulatory Approvals for the Plant
28th February 2014 Claris Lifesciences Limited 6
Approvals by key regulatory authorities
Authority Country
United States of America
United Kingdom & European Union
Australia & New Zealand
Gulf Cooperation Council
Brazil
Colombia
GCC
Authority Country
Tanzania
Uganda
Oman
Ethiopia
Egypt
IndiaFDCA
Diversified Portfolio
28th February 2014 Claris Lifesciences Limited 7
Diversified product portfolio targeted to the Regulated Markets
Anesthesia
► Bupivacaine
► Ropivacaine
► Ketamine
► Lidocaine
► Midazolam
► Propofol
► Propofol MCT-LCT
Anti-Infective
► Aciclovir
► Ciprofloxacin
► Clindamycin
► Fluconazole
► Levofloxacin
► Linezolid
► Meropenem
► Metoclopramide
► Metronidazole
► Paracetamol
Renal Care
► Essential Amino Acids
► Iron Sucrose
Other Injectables
► Diclofenac
► Dobutamine
► Furosemide
► Metoprolol
► Ondansetron
Nutrition & PVE
► Celecel TM-5
► Tetrastarch
► Pentastarch
► Hetastarch
► Amino Acids
► Fat Emulsion
Company Evolution
Head 2000-2005 2006-2009 2010 2012 2013 2014
CapacitySetup first
manufacturing plant.
Setup New plant for Infusion
products
Setup new plant 4 with 4 line
Transferred 2 plant (2 & 4) to the JV as part of
the deal.
FinancialInvestment of $20 mn from
Carlyle
Went public through IPO on
BSE of Rs. 300 Cr.
Received 1050 Cr at an EV of 1313 for the Business
Sale.
Distributeddividend of ~70 Cr and initiated process for buy back of ~230 Cr.
Regulatory
Received cGMPfrom WHO and Plant approval from ENVISA
(Brazil)
Received 50 product
approvals in EU
Received 7 ANDA approvals in the
US
Re-approval fromUSFDA for
manufacturing facility
Received 5 more ANDA approvals
in the US
Business
Setup office in Brazil.
Opened 50+ New countries.
Setup sales office in NJ, US
Commences sales in US
Developed 128 Product basket
and Sold products across
76 countries.
Voted as #1 by the “Best
Companies To Work For” in the
Healthcare sector
Sales of Infusionbusiness (EM) to Otsuka & Mitsui (both Japanese).
28th February 2014 Claris Lifesciences Limited 8
Stable Business Model
28th February 2014 Claris Lifesciences Limited 9
38
48
17
28
54
37
8
8
5
MENA
Latin
Far East
CIS
Asia
Africa
ORM
Europe
USA
Regulated
Market
Emerging
Markets
Track record of successfully launching products across regulated and emerging markets
Overview
►Stable base business with diversified portfolio of current sales across a number of products and in a number of geographies
►Successfully launched 54 molecules till date with another 25 molecules under development
►Robust portfolio of registered products in regulated markets, further complimented by a promising registration pipeline
►Current base business provides a stable revenue stream, with potential to introduce additional products in Regulated Markets
Distribution Network across 84 Countries
28th February 2014 Claris Lifesciences Limited 10
Regulated MarketsEmerging Markets
AFRICAAngolaBeninCameroonEthiopiaGhanaIvory CoastKenyaMadagascarMalawiMaliMauritaniaMauritiusMozambiqueNigeriaSenegalTanzaniaTogoTunisiaUgandaZambiaZimbabwe
ASIABangladeshBhutanCambodiaIndiaIndonesiaLaosMalaysiaNepalPhilippinesSingaporeSri LankaThailandVietnam
CISAzerbaijanBelarusGeorgiaKazakhstanKyrgyzstanRussiaTajikistanTurkmenistanUkraineUzbekistan
LATAMBrazilColombiaMexico
GCC & MEAfghanistanAlgeriaBahrainEgyptJordanKuwaitMaltaMoroccoOmanQatarSaudi ArabiaUAEYemen
OLABoliviaChileCosta RicaDREcuadorEl SalvadorGuatemalaGuyanaJamaicaPanamaParaguayPeruT&TUruguayVenezuela
EUROPEAlbaniaAustriaBalticBelgium BulgariaCzechDenmarkFinlandFranceGermanyGreeceHungaryIrelandItalyKosovoLatviaLithuaniaNetherlandsNorwayPolandPortugalRomaniaSlovakiaSloveniaSwedenUK
ORMAustraliaHong KongItalyNew ZealandSouth AfricaSouth KoreaTaiwan
NORTH AMERICACanadaUSA
Key Competitive Strengths
28th February 2014 Claris Lifesciences Limited 11
7 State-of-the-art manufacturing facilities
2 Diverse portfolio of sterile injectable products across delivery forms
5 Significant upside to the base business via launch of key high value pipeline products
4 Significant value opportunity from a pipeline of products underdevelopment
3 Stable base business and track record of product launches
6 Established sales, marketing and distribution network
1 Focused on the attractive generic injectables market
USA – A Key Market
28th February 2014 Claris Lifesciences Limited 12
USA, 51%
EU, 24%
ORM, 6%
EM, 20%
World Generic Injectables Market Size
Strengths in the US
► Wholly owned subsidiary; Claris Inc.; to manage the front end in the US
► One of the few companies from the Emerging Markets to have its own Front End for the US
► Building its team in the US for future product launches and incremental market reach
► Claris Inc. has tie-ups and is selling in the US through GPOs and wholesalers.
Product Approvals in the USA
Sr. Molecule ANDAsContainer
Glass Vials Bags
01 Ciprofloxacin 2 a a
02 Fluconazole 3 a a
03 Furosemide 1 a
04 Levofloxacin 2 a a
05 Metoprolol 1 a
06 Metronidazole 1 a
07 Norepinephrine 1 a
08 Ondansetron 2 a
Total ANDAs 13
28th February 2014 Claris Lifesciences Limited 13
Growth Strategies
28th February 2014 Claris Lifesciences Limited 14
Organic growth via capacity expansion and introduction of new delivery systems
Developing capabilities for manufacturing of aseptic products in addition to the terminally sterile products currently
Increase focus on bag products and other niche ‘difficult to manufacture’ products
Acquisition of ANDAs and additional products for inorganic growth
Focus on increasing market share for certain key and high potential products
Intensify growth in all international markets, especially the regulated markets through launch of a high value product pipeline
325 865
1,610 2,040
632
678
1,909
2,596
2014 2015 2016 2017
EU US
Going Ahead...
Activities
• Installing two SVP lines in a new plant
Clarion 5, targeted for sales in Regulated
Markets of US and EU.
• Working towards filing at 15+ ANDAs every
year with an intention to reach a 100 ANDA
pipeline in the next 3 years.
• The focus of New Product Launches to
move to US and EU, 45 products; currently
under various stages of development.
Result
• Addressable market size of Claris products
in US and EU to reach $ 4.6 Bn by 2017
28th February 2014 Claris Lifesciences Limited 15
1330
22
70
2014 2017
Reg U.Reg
35
100
ANDA Filings
Estimated Addressable Market size (USD Mn)
957
1,544
3,519
4,636
Source: IMS Data and Company’s Internal Estimates
Thank you...
Our endeavour is to help preserve
Earth’s most precious resource...
Human Lives