Claris life investor relations-presentation-may 2015

1. 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

2. 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

3. •About Claris Lifesciences Limited
• Corporate re-structuring
• Business Overview -Claris Injectables Limited
• Financial Performance – CY 2014
•Corporate Social Responsibility
Key Contents
www.clarislifesciences.com 3

4. About Claris Lifesciences Limited
www.clarislifesciences.com 4
(The Holding Company)
•The Leader
•Vision & Mission
•Our Evolution
•Corporate Facts

5. www.clarisotsuka.comMr. 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
www.clarislifesciences.com 5
The Leader
Vision &
Mission
Evolution
Corporate
Facts

6. 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
www.clarislifesciences.com 6
The Leader
Vision &
Mission
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.”

7. CLARIS LIFESCIENCES LIMITED
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
www.clarislifesciences.com 7
The Leader
Vision &
Mission
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
20142013201220102006 - 20092000 -2005 2015
Introduced
Aseptic &
Lyophilized
production
capabilities
Received API
Plant approval
for Iron Sucrose.

8. 1993 3.088
1000
2479
4.056
5200
2206
CY 2013 CY2014 Projection CY 15
CLL (Group) CIL COL Total CIL Growth%
Corporate Facts
CLARIS LIFESCIENCES LIMITED
 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
www.clarislifesciences.com
Expected increase from 29% of CY 2014 to 32% in CY 2015
EBITDA
Margin%
Claris Lifesciences Ltd : Revenues (INR Mn)
8
The Leader
Vision &
Mission
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%

9. Corporate Restructuring
www.clarislifesciences.com 9
•Holding Structure
•JV for Infusion Business
•Current Group Structure

10. 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)
www.clarislifesciences.com 10

11. 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!
www.clarislifesciences.com
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
CLL
Manpower:121
Sr. Management
TreasuryManagement
CIL
Manpower:957
Plants: 3
SpecialityInjectables
(International Business)
COPL
Manpower:986
Plants: 2
Infusion Business
(Domestic & Emerging Market)
Claris Lifesciences Limited
(Holding Co.)

12. www.clarislifesciences.com
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
CLARIS LIFESCIENCES LIMITED
Holding Structure JV for Infusion Business Current Group Structure

13.  Current Group Structure
Claris Otsuka Pvt Ltd
(COPL)
Claris Injectables Ltd
(CIL)
Icubix Infotech
Claris Lifesciences Ltd
Mr. Arjun Handa
Promoter, Vice Chairman & MD
www.clarislifesciences.com 13
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

14. Claris Injectables Limited (CIL)
A highly attractive pure-play generic Injectables company
www.clarislifesciences.com 14
•About CIL
•Commercial Strategy
•US Market
•EM Market
•Key Products
•Manufacturing Infrastructure
•FDA Interaction
•Other Updates

15.  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
www.clarislifesciences.com 15
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

16. www.clarislifesciences.com
 Our focus – general Injectables segment of the market
CLARIS INJECTABLES LIMITED
 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

17. www.clarislifesciences.com
 General Injectables segment - Competitive and regulatory environment
CLARIS INJECTABLES LIMITED
 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

18. www.clarislifesciences.com
 Therapeutic focus
CLARIS INJECTABLES LIMITED
•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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

19.  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
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 19
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

20.  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
CLARIS INJECTABLES LIMITED
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
www.clarislifesciences.com 20
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

21. www.clarislifesciences.com
 Broad product capabilities across various platforms
CLARIS INJECTABLES LIMITED
• 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

22. www.clarislifesciences.com
 Global Commercial Presence
CLARIS INJECTABLES LIMITED
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

23. www.clarislifesciences.com
 Strong R&D and regulatory capabilities
CLARIS INJECTABLES LIMITED
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

24. www.clarislifesciences.com
 On course to become a significant player in the US
CLARIS INJECTABLES LIMITED
11
9
23
22
20 2
13
100
Launched 2015 2016 2017 2018 2019 2020 Total
ANDA Approval Pathway
24
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

25. www.clarislifesciences.com
 Pipeline Launch Profile
CLARIS INJECTABLES LIMITED
 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
About CIL
Commercial
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

26. Commercial strategy
CLARIS INJECTABLES LIMITED
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
PeruVenezuela
Ukraine
www.clarislifesciences.com 26
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

27. 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:
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 27
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

28. 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 WholesalersManufacturing
CIL Third Parties
US market access strategy
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 28
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

29. Sales
team
CIL
Wholesaler GPO
Hospitals
Product price
offer
Purchasing decision
information to hospital at
selection
US commercial value chain
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 29
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

30. US Organization Structure
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 30
About CIL
Commercial
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
EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

31. Our Approach to Emerging Markets
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 31
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Tier 1
Emerging
Markets
1
Other
Emerging
Markets
2
Other
Updates

32. Strategy for Tier 1 Emerging Markets
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 32
About CIL
Commercial
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

EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

33.  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
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 33
About CIL
Commercial
Strategy
US Market Key Products Manufacturing
Infrastructure
FDA
Interaction
Other
Updates
EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

34. Propofol – a highly differentiated injectable product
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

35. Global Scale Manufacturing Infrastructure for Propofol
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

36. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
 Innovator: Vifor
 Innovator Brand: Venofer
Product
Details
 Iron deficiency anaemiaIndication
 Off patent worldwide
Patent
Status
 Colloidal solution with suspended particlesTechnology
 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

37. Global Scale Manufacturing Infrastructure for Iron Sucrose
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

38. Top Products in US Market Size ($m) Claris Position
Product 1 240 Pipeline Product
Product 2 254 Pipeline Product
Product 3 10 Under Development
Product 4 58 Pipeline Product
Product 5 26 Under Development
Levofloxacin 63 Marketed
Product 7 47 Pipeline Product
Product 8 27 Pipeline Product
Product 9 40 Pipeline Product
Product 10 13 Filed
Product 11 10 Pipeline Product
Metronidazole* 15 Marketed
Ciprofloxacin 14 Marketed
Product 14 13 Pipeline Product
Fluconazole 10 Marketed
Well Positioned to become significant player in Bag Products
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com 38
About CIL
Commercial
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
EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

39. Robust manufacturing infrastructure
CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

40. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

41. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
Overview of manufacturing operations
Clarion I – FDF Facility Clarion III – API FacilityClarion 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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

42. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
Manufacturing facility plan
Claris Otsuka Limited (JV)
Clarion II – FDF Facility
Clarion III – API Facility
Clarion I – FDF Facility
Area for new plant
42
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

43. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

44. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

45. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

46. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

47. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

48. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

49. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

50. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
Corporate Trainings ( Few Key Programs attended by employees)
50
About CIL
Commercial
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
EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

51. CLARIS INJECTABLES LIMITED
www.clarislifesciences.com
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
About CIL
Commercial
Strategy
US Market EM Market Key Products
Manufacturing
Infrastructure
FDA
Interaction
Other
Updates

52. Financial Performance – CY2014
www.clarislifesciences.com 52

53. Financial Performance
 Financials CY 2014 (INR Mn)
www.clarislifesciences.com 53
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.)

54. 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

www.clarislifesciences.com 54
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…

55. Corporate Social Responsibility
www.clarislifesciences.com 55

56. 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
www.clarislifesciences.com 56

57. Corporate Social Responsibility
 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.
“
www.clarislifesciences.com 57

58. Corporate Social Responsibility
 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.
“
www.clarislifesciences.com 58

59. Claris Corporate Headquarter I Nr. Parimal Crossing I Ellisbridge I Ahmedabad I India
www.clarislifesciences.com
Thank You
E-Mail: Investorrelations.corp@clarislifesciences.com