Claris life investor relations-presentation-may 2015

Investor Update 2015

CLARIS LIFESCIENCES LTD (BSE CODE: 533288 SCRIP ID: CLARIS)

A multi-business enterprise with holdings in

Claris Injectables, a wholly-owned subsidiary dealing in Specialty Injectables business

And

20% in Claris Otsuka Pvt. Ltd., a Joint Venture with Otsuka Pharmaceutical Factory, Inc. & Mitsui & Co. Ltd. for Infusion business in India & emerging markets.

www.clarislifesciences.com

Except for the historical information contained here in, statements in this presentation and the subsequent discussions, which

include words or phrases such as “will”, “aim”, “will likely result”, “would”, “believe”, “may”, “expect”, “anticipate”,

“estimate”, “intend”, “plan”, “contemplate”,“seekto”, “future”, “objective”, “goal”, “likely”, “project”, “should”,

“potential”, “will pursue” , “will continue” 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 tor effect events or

circumstances after the date thereof.

DISCLAIMER

www.clarislifesciences.com 2

•About Claris Lifesciences Limited • Corporate re-structuring • Business Overview -Claris Injectables Limited • Financial Performance – CY 2014 •Corporate Social Responsibility

Key Contents


About Claris Lifesciences Limited


(The Holding Company)

•The Leader •Vision & Mission

•Our Evolution

•Corporate Facts

www.clarisotsuka.com Mr. Arjun Handa Promoter, Vice Chairman & MD Claris Lifesciences Limited

Mr. Arjun Handa is the Vice Chairman and MD of Claris Lifesciences Limited. Arjun is an MBA from Northeastern University, Boston, USA and holds a Bachelor of Commerce degree from H L College, Ahmedabad.Arjun's vision is to make Claris, India’s most admired injectables company. Arjun likes to focus on strong entrepreneurial - corporate and marketing strategies and his HR philosophy is evident in setting up the culture of the company. Claris has achieved significant milestones including launching niche difficult to develop products and expand into the regulated markets. Under his leadership, the company has won several awards including the Frost and Sullivan manufacturing award and the "Great Place to Work” award. Apart from work, Arjun likes to read books on entrepreneurship and management, is a car and technology freak and holds a deep interest in world music. He is also a soccer player and in earlier times used to play for his school and college.

THE LEADER


The Leader Vision & Mission

Evolution Corporate

Facts

CLARIS LIFESCIENCES LIMITED

Mission

To be one of the world’s leading and most admired pharmaceutical companies in the global generics industry

To continually create value and bring pride to our stakeholders, partners, customers and the community at large

To preserve Earth’s most precious resource… Human lives

A world-class organization, built on:

Achieved in a manner of fairness, honesty and corporate responsibility

Outstanding performance led by an entrepreneurial culture

Product quality through emotional pharmacopoeia

Management capability, efficient processes and technology

Youth, hard work and discipline



Evolution Corporate

Facts

Vision

“Commitment to achieve a level of perfection that matches the highest international pharmacopoeial standards.”

Quality Philosophy

Our final test for Quality is a very simple question that we ask ourselves without fail,

"Would we use it to treat our dearest ones?" If the answer is an unhesitant "Yes," then the product has passed our final quality test.

We call this "Emotional Pharmacopoeia.”


Set up office in Brazil. Opened 50+ New countries

Set up Sales office in NJ, US Commences Sales in US

Investment of $20 mn from Carlyle

Developed128 Product basket and Sold products across 76 countries.

Went public through IPO on BSE of Rs. 300 Cr

Voted as #1 by the “Best Companies To Work For” in Healthcare sector

Capacity

Financial

Regulatory

Business

Grew the Infusion Business in India & EM markets.

Received cGMP from WHO and Plant approval from ENVISA (Brazil)

Received 50 product approvals in EU

Received7 ANDA approvals in the US

Re-approval from USFDA for manufacturing facility

Set up first manufacturing plant and the API Plant

Set up New Plant for Infusion products

Set up 4th Plant with 4 Line



Evolution Corporate

Facts

Sales of Infusion business (EM) to Otsuka & Mitsui (both Japanese).

Received 1050Cr at an EV of 1313 for the Business Sale.

Received 5 more ANDA approvals in the US

Transferred 2 plant (2 & 4) to the JV as part of the deal.

Distributed dividend of ~70 Cr and initiated process for buy back of ~230 Cr. Overall 7% revenue growth compared to 2013.

Set up new plant for Critical care targeting US, EU & ORM

Formation of CIL with Org. Restructuring

Production capability for Aseptic & Lyophilized products added in new plant.

Company Evolution

2014 2013 2012 2010 2006 - 2009 2000 -2005 2015

Introduced Aseptic & Lyophilized production capabilities

Received API Plant approval for Iron Sucrose.

1993 3.088 1000

2479

4.056

5200

2206

CY 2013 CY2014 Projection CY 15

CLL (Group) CIL COL Total CIL Growth%

Corporate Facts


One of the largest pure-play sterile generic injectable companies in India

Global business with sales in 90+ countries

Two business units:

– Generic Injectables subsidiary

– 20% stake in the infusion business JV with Otsuka

Founded in 1999

Based in Ahmedabad, India

Listed on Bombay Stock Exchange (BSE) since December 2010

Well-Recognised Pharmaceutical Company

India’s Best Companies to Work (2010 -2014) - The Economic Times

India Innovative 100 – Inc. India

India Manufacturing Excellence Awards – The Economic Times and Frost & Sullivan

Our endeavor is to help preserve earths most precious resource . . . Human Lives


Expected increase from 29% of CY 2014 to 32% in CY 2015 EBITDA Margin%

Claris Lifesciences Ltd : Revenues (INR Mn)

8


Evolution Corporate

Facts

6678 7144 6200

Post JV for Infusion Business in 2013, COL pass through sales revenue is included in CLL revenue for CY 2014 & Projection CY 15

64% 28%

Corporate Restructuring


•Holding Structure

•JV for Infusion Business •Current Group Structure

On the 1st of November, after the receipt of the Board and Shareholder’s approval the Speciality Injectable Business has been transferred to a wholly owned subsidiary;

Claris Injectables Limited (CIL)


Claris Injectables Ltd Claris otsuka (P) Ltd

100% Stake 20% Stake

CIL CO(P)L

Claris Lifesciences Ltd(Holding Co.)

Holding Company : Strategic move for future growth

Group Strategic Driver

100% Stake of Claris Injectables Ltd (CIL).

20% Stake of Claris Otsuka (Pvt) Ltd. (CO(P)L)

Pass Through Sales of CO(P)L & CIL.

Treasury & Cash Management

Holding Co. Role & Revenue Source

Dedicated resource allocation & teams in subsidiaries for Operation

As a Group – to drive strategic initiatives.

Clear reporting of all business segments

To decentralize operational decision process

Strategic team to work on new business ventures

Why this Restructuring!


Holding Structure JV for Infusion Business

CORPORATE RESTRUCTURING

Current Group Structure

*Manpower as on 31st Mar 2015 11

Claris Otsuka (P) Limited(20% Stake)

Claris Injectables Limited(100% owned Subsidiary)

Total

Manpower

2064

CLLManpower:121

Sr. Management

Treasury Management

CIL

Manpower:957

Plants: 3

Speciality Injectables

(International Business)

COPL

Manpower:986

Plants: 2

Infusion Business

(Domestic & Emerging Market)

Claris Lifesciences Limited(Holding Co.)


Joint-venture of the Infusion Business with Otsuka & Mitsui

Common solutions, plasma volume expanders & parenteral nutrition therapies for India & Emerging Markets

Historically accounted for c.55% of the overall Claris business

Formed a joint venture (JV) in August 2013 with Otsuka and Mitsui

Claris holds 20% stake in the JV

Claris retains top managerial positions and operational control of the JV

Cash consideration of $193 million to Claris for 80% stake in the JV

Claris-Otsuka to co-brand its products in India and across Emerging Markets

Two of the four manufacturing plants of Claris were transferred to the JV

Debt prepayment - $60 million

Buyback of shares - $50 million

General corporate purposes - $83 million

Business Overview

Transaction Terms

Fund Utilization

12


Holding Structure JV for Infusion Business Current Group Structure

Current Group Structure

Claris Otsuka Pvt Ltd (COPL)

Claris Injectables Ltd (CIL)

Icubix Infotech

Claris Lifesciences Ltd

Mr. Arjun Handa Promoter, Vice Chairman & MD


CORPORATE RESTRUCTURING

Holding Structure JV for Infusion Business Current Group Structure

President, HRM

& Communication

25 years experience

Sr. Vice President, Corporate Affairs & Development

23 years experience

President, Finance

18 years experience

Joint CEO – Technical and Supply Chain

42 years experience

Joint CEO – Sales, Finance and HR

20 years experience

Vice President, Sales

18 years experience

Sr. Vice President, Information Technology

21 years experience

CEO

13 years experience

Sr. Vice President, Manufacturing & SCM,

COL

28 years experience

Claris Injectables Limited (CIL) A highly attractive pure-play generic Injectables company


•About CIL

•Commercial Strategy

•US Market •EM Market •Key Products •Manufacturing Infrastructure

•FDA Interaction

•Other Updates

Claris At A Glance…

One of the largest Indian sterile injectables pharmaceutical companies

Diversified revenue base across a range of products offerings sold in a number of countries in regulated as well as emerging markets

Products range across various therapeutic segments, including anesthesia, critical care, renal care, and nutrition

In- house development and regulatory capabilities with over 1000+ product registrations filings worldwide

Market presence across 100+ countries worldwide, including regulated markets of US and Europe

Established sales, marketing and distribution network through distributors & subsidiaries

Manufacturing facility at a campus located in Ahmedabad, India with approval from

key global regulatory agencies

Strong financial profile with significant growth potential, best-in-class profitability margins and stable cash-flow profile

Revenue

Products

R & D

Market

Network

Manufacturing

Overall

Size

CLARIS INJECTABLES LIMITED


About CIL Commercial

Strategy US Market EM Market Key Products

Manufacturing Infrastructure

FDA Interaction

Other Updates


Our focus – general Injectables segment of the market


Large and growing market with attractive industry dynamics

General Injectables with c.$6bn market size represents the largest segment of the generic Injectables

Market growing at a robust 17% CAGR (10-13)

General

injectables

73%

Oncology

17%

Beta-

lactam

antibiotics

8%

Others

2%

+7% +8% +17%

Oncology General Injectables

US Generic Injectables Market

$8bn

2010-13

Growth rate for generic segment

Beta-lactam antibiotics

16




FDA Interaction

Other Updates


General Injectables segment - Competitive and regulatory environment


Sophisticated manufacturing process

High regulatory standards and increased FDA oversight

Investment required to build and maintain Injectables manufacturing infrastructure

23%

7%

8%

27%

35%

% Sales

1 company

2 companies

3 companies

4 companies

5+ companies

32%

22%

13%

10%

20%

% Products

1 company

2 companies

3 companies

4 companies

5+ companies

Regulatory Environment

Competitive Environment

c.38% of sales from injectable generic products with three or fewer competitors

c.70% of sales from injectable generic products have three or fewer competitors

Top 3: 38%

Top 3: 70%

17




FDA Interaction

Other Updates


Therapeutic focus


•Propofol

•Bupivacaine

•Lidocaine

•Paracetamol

•Midazolam

•Levofloxacin

•Ciprofloxacin

•Metrodinazole

•Fluconazole

•Aciclovir

•Iron Sucrose

•Furosemide

•Ondansetron

•Norepinephrine

•Heparin

Therapy Anesthesia & Analgesics Anti-Infectives Critical Care & Renal

Products 11 16 27

Registrations 25 156 157

Top 5 Products

18




FDA Interaction

Other Updates

Regulatory Approvals

Authority Country

United States of America

United Kingdom & European Union

Australia & New Zealand

GCC Gulf Cooperation Council

Brazil

Colombia

Authority Country

Tanzania

Uganda

Oman

Ethiopia

Egypt

India






FDA Interaction

Other Updates

http://www.google.co.in/url?url=http://www.minsalud.gov.co/Paginas/Gobierno Nacional fortalece al INVIMA como agencia sanitaria del pa%C3%ADs.aspx&rct=j&frm=1&q=&esrc=s&sa=U&ei=a3nsU_CWO9Xi8AXd9oHABA&ved=0CBkQ9QEwAg&usg=AFQjCNEBJfuqhAWme_szrGAkFyb-6-_OFw

http://www.google.co.in/url?url=http://eindia.eletsonline.com/2013/Hyderabad/Governance/xln-xtended-licensing-laboratory-node-food-and-drugs-control-administration/&rct=j&frm=1&q=&esrc=s&sa=U&ei=hXzsU-qgLYfs8AWOr4HgCQ&ved=0CBkQ9QEwAg&usg=AFQjCNF_95IHrQN25rvQajz9jeisqwiPsQ

Full-fledged front-end presence in US & India Sales in Europe, Canada and ANS Sales in over 70 emerging markets including Brazil, Russia

Fully Integrated Injectables Platform


Product Development

Regulatory

Manufacturing

Sales, Marketing & Distribution

33 products developed and launched 46 employees Expertise in fat emulsions and pre-mix bag products

In-house regulatory capabilities 36 employees Registrations in over 100 countries 548 registrations worldwide

3 manufacturing units 503 employees FDA, MHRA, TGA, ANVISA & GCC approved Only Indian company with regulated market capabilities across complex delivery system and technology





FDA Interaction

Other Updates


Broad product capabilities across various platforms


• Delivery System

• Technology

PVC/PVC-Free Bags

Vials/Bottles

Ampoules

Emulsion & other complex forms

Aqueous

Lyophilisation

7

34

13

3

31

--

14

184

117

52

255

8

Annual Capacity(Mn)

Products

21




FDA Interaction

Other Updates


Global Commercial Presence


US & Canada

Other regulated markets

Other emerging markets

Latin America

Corporate headquarters

US; 23%

Other

Regulated

Market,

27%

Emerging

Market,

50%

Sales in over 100 countries

Direct sales in US and India. Sales through distributors in rest of the world

Strong presence in non-US regulated markets including Europe, Canada, Australia, New Zealand and South Africa

Leader in emerging markets with sales in over 70 countries

Strong Commercial Presense

2014 Revenue

22




FDA Interaction

Other Updates


Strong R&D and regulatory capabilities


Key Facts

Products*

8 12 13

46

US Europe Other Regulated

Markets

Emerging

Markets

US; 13

Europe,

125

ORM; 41 Emerging

Markets,

369

548

Registrations

46 highly qualified employees across R&D, F&D and analytical development

Strong expertise in products in PVC/PVC-free bags and fat emulsion technology

33 products developed and successfully launched in the market

Capabilities to develop c.25 products per year including 12-15 products for the US market

Active R&D programme addressing a c.$5 billion market opportunity in the regulated markets

36 highly experienced employees in regulatory affairs

548 registrations currently

23




FDA Interaction

Other Updates


On course to become a significant player in the US


11

9

23

22

20 2

13

100

Launched 2015 2016 2017 2018 2019 2020 Total

ANDA Approval Pathway

24




FDA Interaction

Other Updates


Pipeline Launch Profile


Business poised for significant growth from an attractive and unencumbered pipeline

Targeting a portfolio of 127 products spread across 2,486 registrations by 2020

*A launch is considered to be the launch of one product in one geography

25


Strategy US Market

Cumulative Addressable Opportunity in Regulated Markets for All Products ($ million)

1.210

2.356

2.882

4.071

5.119 5.188

2015 2016 2017 2018 2019 2020

EM Market Key Products Manufacturing Infrastructure

FDA Interaction

Other Updates

Commercial strategy


Russia Mexico

Brazil Philippines

US and India

Other Emerging Markets

1

4

India

US

Others (58)

Direct sales

US

– Wholly owned subsidiary

– 6 employees including 2 senior sales Executives

India

– Sales marketing and distribution network

Europe and ORM

2 EU (25)

Canada Aus

S. Korea

Others (4)

Distributors

Country managers based in India, managing distributor relationships

Registrations in 25 European countries

Tier 1 Emerging Markets

3

Others (6)

Distributors

Distributors Country managers based in India, managing

distributor relationships

Commercial Strategy

Key Highlights

Country manager based in the country

Operating business infrastructure in key Latin American countries

Colombia

Peru Venezuela

Ukraine





FDA Interaction

Other Updates

USA – A Key Market

USA, 51%

EU 24%

EM, 20%

ORM 6%

• 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.

World Generic Injectables Market Size: Strengths in US Market:






FDA Interaction

Other Updates

Strategy Target Audience

Group Purchasing Organisations Broad coverage of GPOs and wholesalers

Participate in the GPO bids

Actively promote through marketing programmes

Intense conference participation for greater visibility across

all the stakeholders

Wholesalers

R&D Regulatory

Filling

Sales

&

Marketing

3PL Wholesalers Manufacturing

CIL Third Parties

US market access strategy






FDA Interaction

Other Updates

Sales team

CIL

Wholesaler GPO

Hospitals

Product price offer

Purchasing decision information to hospital at

selection

US commercial value chain






FDA Interaction

Other Updates

US Organization Structure




Strategy US Market

Jt. CEO

Vice President

Sales Marketing Operations Regulatory

Compliances Finance

VP- Sales

Director Sales – West

Director Sales – East*

Director Sales – Central *

Head – Marketing*

Manager

Head – Operations*

Director – Ops.

Manager – Operations*

Sr. Director

Manager*

Manager*

DGM

* New Positions


FDA Interaction

Other Updates

Our Approach to Emerging Markets






FDA Interaction

Tier 1

Emerging Markets

1

Other

Emerging Markets

2

Other Updates

Strategy for Tier 1 Emerging Markets




Strategy US Market

Presence of Claris manager in each country

Dedicated Claris account managers and focused sales representatives from distributors

Claris country manager closely coordinates with distributors in terms of training & development, marketing and operations

Closely work in the market with distributor’s sales team

Participation in local conferences and marketing events


FDA Interaction

Other Updates

Innovator: AstraZeneca

Innovator Brand: Diprivan

Product Details

Indication: Anaesthesia

“Gold Standard” in the market Product Details

US: Patent until 22 Sept 2015

Ex-US: Off-patent

PARA IV filed

Expecting launch in 2016

Patent Status

Fat emulsion technology

Mix of oil and water

Difficult to manufacture and stabilise

Technology

Global market size of c.US$900m

US market size of c.US$245m with a 2010-2013 historical CAGR of c.29%

Market Size

Propofol – key facts




Strategy US Market Key Products Manufacturing

Infrastructure FDA

Interaction Other

Updates EM Market Key Products


FDA Interaction

Other Updates

Propofol – a highly differentiated injectable product



Unique Formulation

Unique and difficult to stabilise emulsion formulation comprising of soya oil and water

Requires multiple formulation development to address the global market demand

Requires highly complex manufacturing infrastructure

Oil and water mixture creates mixing and sterilization challenges

Need of a separate manufacturing line with significantly higher investment

Requires complex bioequivalence studies in hospitalized setting

1

Manufacturing Complexities

Regulatory Challenges

3

2

34




FDA Interaction

Other Updates

Global Scale Manufacturing Infrastructure for Propofol



US 105

EU 90

ANS 8

Canada 5

In Units Million (20ml equivalent)

The global regulated markets of US, EU, ANS and

Canada have sales of c.200 million units annually (20ml

equivalent)

With its current capacity CIL can address c.25% of overall

Propofol manufacturing requirements in global regulated

markets

Significant headroom to further expand manufacturing

capacity

India cost advantage allows CIL to be cost competitive

on a sustainable basis

Capacity to address 25% of global requirements with India cost advantage

35




FDA Interaction

Other Updates



Innovator: Vifor

Innovator Brand: Venofer

Product Details

Iron deficiency anaemia Indication

Off patent worldwide Patent Status

Colloidal solution with suspended particles Technology

Global market size: c.US$530m

US market size of c.US$320m with a 2010-2013 historical CAGR of 8%

Market Size

Iron Sucrose – key facts

36




FDA Interaction

Other Updates

Global Scale Manufacturing Infrastructure for Iron Sucrose



The global regulated markets of US, EU, ANS and

Canada have sales of c.21 million units annually (5ml

equivalent)

With its current capacity CIL can address c.28% of overall

Iron Sucrose manufacturing requirements in global

regulated markets

Sufficient headroom to expand API manufacturing

capacity

India cost advantage allows CIL to be cost competitive

on a sustainable basis

Capacity to address 28% of global requirements with India cost advantage

US 12,4

EU 8,1

ANS 0,2

Canada 0,4

In Units Million (5ml equivalent)

37




FDA Interaction

Other Updates

Top Products in US Market Size ($m) Claris Position

Product 1 240 Pipeline Product


Product 3 10 Under Development


Product 5 26 Under Development

Levofloxacin 63 Marketed




Product 10 13 Filed


Metronidazole* 15 Marketed

Ciprofloxacin 14 Marketed


Fluconazole 10 Marketed

Well Positioned to become significant player in Bag Products




Strategy US Market

*Includes addressable market of products in vial format. Management believes that bags are the preferred format and can replace vials

• Currently markets 4 products in the US with an addressable market size of c.$100 million

• Attractive and unencumbered pipeline expected to drive growth

Key Competitive Strengths for Bag Products

Claris is also developing some of these products in other delivery systems.

Only emerging market supplier of injectable products in bag forms in the US and other regulated markets

Highly differentiated capabilities in the development, manufacturing and supply of PVC/PVC-free bags

Registrations across the world including US, Europe and emerging markets

Easily scalable manufacturing capabilities; current capacity to manufacture 14 million bag products annually


FDA Interaction

Other Updates

Robust manufacturing infrastructure



Key Facts

State-of-the-art manufacturing infrastructure spread over 166,800 square metres in Ahmedabad, India

Two FDF facility and one API facility all located in a single campus

Broad product capabilities across different technologies like ampoules, vials, emulsions, aqueous, bags, lyophilisation

Production capacity of 315 million units by December 2014

503 FTEs in manufacturing and quality control

86% of total sales in 2014 from own-manufacturing plants; expected to reach c.98% of total sales by 2020

39




FDA Interaction

Other Updates



World-class equipment from leading global suppliers including lumat, Groninger, Christ, Stillmas, Diesel,

Clestra, Bomer, Nikka Densok, etc.

State-of-the-art technology

On-going investment for continuous upgrading and improvements of the facility

Well-Invested Facility

3 successful FDA inspections in last 3 years

Approvals from other key global regulatory agencies such as MHRA, TGA, ANVISA and GCC

New manufacturing plant approved by MHRA in August 2014

Regulatory Compliance

Range of delivery systems, such as PVC/PVC-free bags, glass containers and ampoules

Technological capabilities across emulsion, lyophilised and aqueous injectable forms

Ability to manufacture products in varied delivery systems catering to specific geographic requirements

Iron Sucrose in vial for US and ampoules for non-US markets

Ciprofloxacin / Levofloxacin / Metronidazole in glass / PVC / non-PVC form

Production Versatility

Current capabilities sufficient to support near-term growth

c.$27m investment in a new manufacturing facility

Headroom to set 2 additional lines in the new facility

Significant Headroom for Future Expansion

Robust manufacturing infrastructure

40




FDA Interaction

Other Updates



Overview of manufacturing operations

Clarion I – FDF Facility Clarion III – API Facility Clarion II – FDF Facility

Manufacturing Area 14,400 square metres 4,100 square metres 13,145 square metres

Capabilities Aqueous, emulsion

Bags, vials, ampoules

API production for:

– Iron Sucrose

– Hydroxyethyl Starch

– Dexmeditomidine

Aqueous, lypholised

Ampoules, vials

Capacity 5 lines

115 million units (2014)

Iron Sucrose – 1 ton per Month

HES – 4 tonnes per Month

Dexmeditomidine

4 lines (2 lines already in place)

200 million units (2014)

Key Regulatory Approvals

FDA, MHRA, TGA, ANVISA FDA-approved

Iron Sucrose

MHRA approved

FDA inspection expected in Q3 2015

41




FDA Interaction

Other Updates



Manufacturing facility plan

Claris Otsuka Limited (JV)

Clarion II – FDF Facility

Clarion III – API Facility

Clarion I – FDF Facility

Area for new plant

42




FDA Interaction

Other Updates



History of FDA interaction

•Receipt of first complaint and product recall •Fourth FDA inspection •Issue of warning letter

2009

2010

2011

2012

•Third FDA inspection

•Interaction with FDA •Request for site inspection

•Fifth FDA inspection •Closure of all violations in the warning letters

2006 •First FDA inspection

2008 •FDA approval and second FDA inspection

2013 •Sixth FDA inspection

2014 •Cleared sixth FDA inspection •Approval of API plant

Six FDA inspections since 2006

43




FDA Interaction

Other Updates



Summary of FDA’s warning letter

Complaints: Three complaints found in bags in 2010 of the total 1.7m bags supplied to the US market

Reason for leakage: Hot foil printing technology

Result: FDA warning letter

Key observations:

– Inadequacy in global reporting

– Critical observations regarding validation system

– No adverse comment on equipment, set-up or data integrity

44




FDA Interaction

Other Updates



Hiring of Lachman and Protocol Link

Consultant

Description

Most reputable consultant in the industry

Role: Closing the I483 for unannounced inspection

Time spent: 6 months long and 15 man-days in total

Well-renowned consultant

Role: Internal inspection and building of QSEP

Time spent: 6 months and 300 man-days in total

Key Recommendations

Reorganise the QA/QC departments

Replace the printing machine that caused the leakage

Establish SOPs for all practices

Improve documentation

Add accountability for line managers

45




FDA Interaction

Other Updates



Well-defined product selection criteria

Feasibility study

Market potential

Therapeutic focus

Strategic fit

Margin potential

Product Selection for R&D

CIL’s product selection criteria is based on:

- Technical feasibility study: can the

product be delivered using CIL’s

existing delivery technologies?

- Therapeutic focus: does the product fit

with CIL’s portfolio and therapeutic

capabilities?

- Market potential: does the product

have strong market dynamics and

growth potential?

- Margin: does the product have good

margin potential?

- Strategic fit: does this product fit with

the overall strategy of the business

46




FDA Interaction

Other Updates



HR practices

HR Philosophy

People are the “cornerstone” & “driving force” for sustainable growth

Value-based culture of excellence and desire to be among the world’s most admired organizations

Commitment to help employees make a difference to the world, and through their work, be a source of pride to their country, family, and themselves

Professional approach of offering an individual a challenging career rather than a job

47




FDA Interaction

Other Updates



Multiple accolades for HR practices

Awarded one of the best companies to work for in India 5 years consecutively from 2010 to 2014 by The Economic Times

Merit Award 2014 SPC, Sri Lanka

In-House Communication Excellence Award 2014

Certificate of Excellence for smart innovation - 2013

Greentech HR Excellence Awards -2010

48




FDA Interaction

Other Updates



Talent development and retention strategy

Induction & Orientation programs:

– Functional overview

– Manufacturing campus visit

– Sessions by senior management

– Product

– IT training

Learning & knowledge enhancement through international trips, and sponsorships to seminars/conferences

Induction & Learning

Behavioural programs and trainings:

– Managerial Leadership Programs

– Managerial Executive Programs

– External trainings at prestigious institutes

Functional trainings

– Capsule courses – pharmacy, engineering, dossier preparation, finance for non-finance managers

Capability Enhancement Programs (Trainings)

Frequency: Annually, usually in July for all confirmed members

Criteria: Performance & potential – Quantitative & Qualitative parameters

Process: Performance evaluation form along with criteria & guidelines

Increments approved by function heads and finalized by Committee / CEO

Performance Review Policies

Behavioural programs and trainings:

– Managerial Leadership Programs

– Managerial Executive Programs

– External trainings at prestigious institutes

Functional trainings

– Capsule courses – pharmacy, engineering, dossier preparation, finance for non-finance managers

Career Planning & Progression

49




FDA Interaction

Other Updates



Corporate Trainings ( Few Key Programs attended by employees)

50


Strategy US Market

Program Institute

Business Strategy for HR Leaders INSEAD, Singapore

Leading Successful Change INSEAD, Singapore

Leading People Organization Wharton, Mumbai

Maximizing your Leadership Potential HBS, Mumbai

Leadership Skills for Top Mgt. INSEAD, Singapore

Leading for Results INSEAD, Singapore

Leading People Organizations Wharton, Mumbai

Finance for non-finance managers IIM, Bangalore


FDA Interaction

Other Updates



Improving the quality of living for employees

Festival Celebration Activities

Celebrations of functional achievements & traditional festivals

Talent Shows & Special Days Celebration

C–Bash (Creativity Bash unveiling hidden talent in music, plays, etc.)

Independence Day, Women’s Day, Christmas, Diwali

Organization of sports competitions

Organization of cultural activities and welfare campaigns

Dedicated area for playing indoor games with fitness and

recreation including air hockey, basketball nets, boxing

bags and darts

51




FDA Interaction

Other Updates

Financial Performance – CY2014


Financial Performance

Financials CY 2014 (INR Mn)


For CY 2014: CLL Revenue includes income from Pass trough sales from COPL, Treasury & Cash Management For CY 2015: Pass through Sales from COPL will reduce due to transfer of infusion business registrations to JV COPL.

4056

1494

3088

551

7144

2045

5200

1820 1000

170

6200

1990

Net Sales EBITDA Net Sales EBITDA Net Sales EBITDA

2014 2015 (P)

941

1106

2009

USA

Other Regulated Market (Excl US)

Emerging Market

Region wise Net Sales – CY 2014 (Speciality Injectables)

Total 4056

29% 32%

Speciality Injectables Treasury + Pass Through Sales Claris Lifesciences Ltd.

Business Segment wise Net sales (INR Mn.)

Growth Strategy

Intensify growth in all international markets, especially the regulated markets through launch of a high value product pipeline 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


5200

CAGR 30%

CY 2015 CY 2018

Estimated Revenue Growth

The Company is well poised to delivery a 30% CAGR over the next 3 years…

Corporate Social Responsibility



Soccer Tournament for pan Gujarat School Children

To promote sports among students Claris sponsored Soccer Tournament for consecutive fourth year in 2014. “ 1296

81

76

65

16

15

Players

Schools

Matches

Boys Teams

Girls Teams

Days



Women’s Running Event : Pinkathon

As part of our CSR philosophy, we co-sponsored and participated in the Pinkathon Amdavad on Oct 12, 2014 at Sabarmati Riverfront. Pinkathon is India’s biggest multi-

city women’s running event to encourage & promote fitness & health among women and create awareness about breast cancer.

“



Half Marathon Powered by Claris

With a goal of improving people's

awareness towards health and

fitness

• 9000 Participants

Half Marathon - powered by Claris

organized on 4th Jan 2015 at Ahmedabad.

“


Claris Corporate Headquarter I Nr. Parimal Crossing I Ellisbridge I Ahmedabad I India


Thank You

E-Mail: [email protected]

Investor Relations

Claris life investor relations-presentation-may 2015