2014 ir ppt claris life science

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Our endeavour is to help preserve Earth’s most precious resource... Human Lives Investor Relations Presentation 2014

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Claris Life Science Investor Presentation

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Page 1: 2014 IR PPT Claris Life Science

Our endeavour is to help preserveEarth’s most precious resource...

Human Lives

Investor Relations Presentation2014

Page 2: 2014 IR PPT Claris Life Science

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

Page 3: 2014 IR PPT Claris Life Science

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

Page 4: 2014 IR PPT Claris Life Science

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

Page 5: 2014 IR PPT Claris Life Science

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

Page 6: 2014 IR PPT Claris Life Science

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

Page 7: 2014 IR PPT Claris Life Science

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

Page 8: 2014 IR PPT Claris Life Science

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

Page 9: 2014 IR PPT Claris Life Science

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

Page 10: 2014 IR PPT Claris Life Science

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

Page 11: 2014 IR PPT Claris Life Science

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

Page 12: 2014 IR PPT Claris Life Science

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.

Page 13: 2014 IR PPT Claris Life Science

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

Page 14: 2014 IR PPT Claris Life Science

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

Page 15: 2014 IR PPT Claris Life Science

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

Page 16: 2014 IR PPT Claris Life Science

Thank you...

Our endeavour is to help preserve

Earth’s most precious resource...

Human Lives