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
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Claris life investor relations-presentation-may 2015
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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”,
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
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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
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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.”
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
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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
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
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%
Corporate Restructuring
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•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)
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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
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.)
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
Current Group Structure
Claris Otsuka Pvt Ltd (COPL)
Claris Injectables Ltd (CIL)
Icubix Infotech
Claris Lifesciences Ltd
Mr. Arjun Handa Promoter, Vice Chairman & MD
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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
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
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About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
FDA Interaction
Other Updates
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
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
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.$5 billion market opportunity in the regulated markets
36 highly experienced employees in regulatory affairs
548 registrations currently
23
About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
FDA Interaction
Other Updates
www.clarislifesciences.com
On course to become a significant player in the US
CLARIS INJECTABLES LIMITED
11
9
23
22
20 2
13
100
Launched 2015 2016 2017 2018 2019 2020 Total
ANDA Approval Pathway
24
About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
FDA Interaction
Other Updates
www.clarislifesciences.com
Pipeline Launch Profile
CLARIS INJECTABLES LIMITED
Business poised for significant growth from an attractive and unencumbered pipeline
Targeting a portfolio of 127 products spread across 2,486 registrations by 2020
*A launch is considered to be the launch of one product in one geography
25
About CIL Commercial
Strategy US Market
Cumulative Addressable Opportunity in Regulated Markets for All Products ($ 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
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
Peru Venezuela
Ukraine
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About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
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:
CLARIS INJECTABLES LIMITED
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About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
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
CLARIS INJECTABLES LIMITED
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About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
FDA Interaction
Other Updates
Sales team
CIL
Wholesaler GPO
Hospitals
Product price offer
Purchasing decision information to hospital at
selection
US commercial value chain
CLARIS INJECTABLES LIMITED
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About CIL Commercial
Strategy US Market EM Market Key Products
Manufacturing Infrastructure
FDA Interaction
Other Updates
US Organization Structure
CLARIS INJECTABLES LIMITED
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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
Our Approach to Emerging Markets
CLARIS INJECTABLES LIMITED
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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
Strategy for Tier 1 Emerging Markets
CLARIS INJECTABLES LIMITED
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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
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
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About CIL Commercial
Strategy US Market Key Products Manufacturing
Infrastructure FDA
Interaction Other
Updates EM Market Key Products
Manufacturing Infrastructure
FDA Interaction
Other Updates
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
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
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
Financial Performance – CY2014
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Financial Performance
Financials CY 2014 (INR Mn)
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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
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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
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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
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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.
“
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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.
“
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Claris Corporate Headquarter I Nr. Parimal Crossing I Ellisbridge I Ahmedabad I India