Investor Relations Presentation

Transcription

OUR ENDEAVOR IS TO HELP
PRESERVE EARTH’S MOST PRECIOUS
RESOURCE …HUMAN LIVES
INVESTOR PRESENTATION – March 2016
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.
WWW.CLARISLIFESCIENCES.COM
DISCLAIMER
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”,
“potential”,
“intend”,
“plan”, “contemplate”,“seekto”, “future”, “objective”, “goal”, “likely”, “project”, “should”,
“will pursue” , “will continue” and similar expressions or variations of such expressions may constitute
"forward-looking statements".
These forward looking statements including procedures 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.
www.clarislifesciences.com
2
Corporate Facts
3
CORPORATE PHILOSOPHY
 Vision
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
 Mission
A world-class organization, built on:


Outstanding performance led by an entrepreneurial culture

Product quality through emotional pharmacopoeia

Management capability, efficient processes and technology

Youth, hard work and discipline
Achieved in a manner of fairness, honesty and corporate responsibility

Quality Philosophy
“Commitment to achieve a level of perfection that matches the highest international pharmacopoeial standards.”
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.”
4
CORPORATE FACTS - CLL
Historic evolution of Claris Lifesciences Ltd
2000 -2005
CAPACITY
Set up first
manufacturing
plant and the
API Plant
2006 - 2009
2010
2012
Set up New Plant
for Infusion
Products
Investment of
$20 mn from
Carlyle
Went public
through IPO on
BSE of Rs. 300 Cr
FINANCIAL
REGULATORY
Received cGMP
from WHO and
Plant approval
from ENVISA
(Brazil)
Received 7
ANDA approvals
in the US
Re-approval
from USFDA for
manufacturing
facility
Set up Sales
office in NJ, US
BUSINESS
Commences
Sales in US
2013
2014
Transferred 2
plant (2 & 4)
to the JV as
part of the
deal.
Set up new
plant for
Critical care
targeting US,
EU & ORM
Received
1050 Cr at an
EV of 1313 for
the Business
Sale.
Distributed ~300 Cr
for Buyback &
dividend .
Received 5
more ANDA
approvals in
the US
Received API
Plant approval
for Iron Sucrose.
Sales of Infusion
business (EM) to
Otsuka & Mitsui
(both
Japanese).
Formation of
CIL with Org.
Restructuring
2015
Production
capability for
Aseptic &
Lyophilized
products added in
new plant.
Revenue for SIB
grew by 39% for
FY16 compared
to previous year.
5
CORPORATE FACTS - CIL
Key Takeaways for speciality Injectables Business

One of the largest pure-play sterile
Our endeavor is to help preserve earths most precious resource . . .
Human Lives
generic injectable companies in India

Global business with sales in 90+
countries

Three Manufacturing Plants

Manufactures and markets products
across multiple delivery systems

Key Strengths
Products ranges in multiple therapeutic
segments including anesthesia, blood
products, anti-infectives, and plasma
volume expanders.
Focusing only on
Injectables
Strong legacy &
knowledge base
Robust Management
bandwidth
6
CORPORATE FACTS - CLL
Management Group Structure
Claris Lifesciences Ltd
(Mr. Arjun Handa)
Promoter, Vice Chairman & MD
Claris Injectables Ltd
(CIL)
Joint CEO
Joint CEO
Sales, Finance & HR
Technical & Supply
Chain
22 years
43 years
President,
Finance
19 years
President,
Corporate Strategy
& Planning
President,
HRM
& Communication
Sr. Vice President,
Sr. Vice President,
24 years
27 years
25 years
22 years
Corporate Affairs
& Development
Information
Technology
7
Industry Overview
8
INDUSTRY OVERVIEW
Global Pharma & Targeted Market
Global Pharma Market : USD 770 bn
Global Injectables Market : USD 150 bn
Generic Injectables Market : USD 20 bn
General
Injectables :
USD 8 bn
Cef, Beta-lactam,
Penam : USD 3 bn
Non Targeted
Products:
USD 3 bn
Selling:
USD 1 bn
Bio tech:
USD 4 bn
Oncology:
USD 5 bn
Targeted Products:
USD 5 bn
Developed/Filed:
USD 2 bn
Pipeline:
USD 2 bn
9
INDUSTRY OVERVIEW
General Injectables segment - Competitive and regulatory environment
Competitive Environment
Regulatory Environment

High entry barriers

Long gestation period

Less than 5 competitors for 70% products

Shortages in the USA

Manufacturing legacy& Technology intensive
% Products
20%
32%
1 company
2 companies
3 companies
10%
4 companies
5+ companies
13%
22%
77% products have 4
competitors or less
10
About Claris Injectables Ltd
www.clarisinj.com
11
CLARIS INJECTABLES LTD - OVERVIEW
Fully integrated Injectables platform
Product
Development

32 products developed
Regulatory

and launched till date
In-house regulatory
capabilities

3 manufacturing units

582 Full time employees

FDA, MHRA, TGA,

55 employees

39 employees

Expertise in fat emulsions

Registrations in over 90
ANVISA, and GCC
countries
approved
and pre-mix bag
products

402 registrations
worldwide.
Sales,
Marketing &
Distribution
Manufacturing

Only Indian company

Full-fledged front-end
presence in US and India

Sales in Europe, Canada
and ANS

Sales in over 75 markets
globally
with regulated market
capabilities across
complex delivery system
and technology
12
CLARIS INJECTABLES LTD – DIVERSIFIED PORTFOLIO
Therapeutic focus
Anaesthesia & Analgesics
Total Products
11
Therapy wise % of Sales
Top 5 Products
Propofol I Bupivacaine I Lidocaine I Paracetamol I Midazolam
Anti-Infectives
Total Products
15
38%
Current
36%
Products:
Top 5 Products
Levofloxacin I Ciprofloxacin I Metrodinazole I Fluconazole I Aciclovir
51
Critical Care & Renal
26%
Total Products
23
Top 5 Products
Iron Sucrose I Furosemide I Ondansetron I Norepinephrine I Heparin
13
CLARIS INJECTABLES LTD – GLOBAL PRESENSE
Global Commercial Presence
Emerging
Market,
29%
FY2016
Other
Regulated
Market,
19%
US, 52%
US & Canada
Other Regulated Markets
Other Emerging Markets
Latin America
Corporate Headquarters
Strong Commercial Presense




Sales in over 75 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 60 countries
14
CLARIS INJECTABLES LTD – DISTRIBUTOR OVERVIEW
Commercial strategy
Commercial
Strategy
1
Direct sales
US and India
India
EU (25)
US
– Wholly owned subsidiary
– 17 employees including 3 senior sales Executives
 India
– Sales marketing and distribution network

US
2
Key
Highlights
S. Korea

Europe and ORM
Canada
Aus
Distributors

Country managers based in India, managing
distributor relationships
Registrations in 25 European countries
Others (4)
Brazil
3
Philippines

Tier 1 Emerging Markets
Russia
Mexico
Distributors

Country manager based in the country
Operating business infrastructure in key Latin
American countries
Others (6)
4
Other Emerging Markets
Venezuela
Peru
Colombia
Ukraine
Distributors

Country managers based in India, managing
distributor relationships
Others (58)
15
CLARIS INJECTABLES LTD – US MARKET
USA – Strong Front-end Operations
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
(Intalere)
Wholesalers
Third parties
R&D
Regulatory
Filling
Manufacturing
Sales
& Marketing
3PL
Wholesalers
16
CLARIS INJECTABLES LTD – US MARKET
Current US Commercial Team – Organization Structure
About Claris Lifesciences Inc.
Jt. CEO
President

Wholly owned operating subsidiary

Competent local management team

Strong focus on the market
Assistant*
Sales
Marketing
Compliance
Regulatory
GMP,
Corp. QA
Operations &
SCM
Finance
VP- Sales
CMO*
Sr. Director
AVP
VP*
GM
AVP
Director
Manager
Manager*
Manager
GM*
Purchase Exe.
Manager
Director*
SCM Manager*
Manager*
Executive
Asst. Mgr.
Executive
Associate
Executive
Executive
Future Plan - Three Sales
Executives
New Positions
17
CLARIS INJECTABLES LTD - MANUFACTURING
State-of-the-art Manufacturing Infrastructure
Key Facts






State-of-the-art manufacturing infrastructure in
a 166,800 sq. mts campus
3 manufacturing units – 2 FDF and 1 API
Well Invested
Facility

World-class equipment from international
suppliers
582 Full Time Employees including 275 in
Manufacturing & 307 in Quality
Large emulsion and bag products
manufacturing capacity


Regulatory
Compliance


World-class equipment from leading global suppliers
including Plumat, 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
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
Approvals by Key Regulatory Authorities
Authority
Country
United States
United Kingdom
Australia
Brazil
GCC
Gulf Countries
18
CLARIS INJECTABLES LTD – CAMPUS OVERVIEW
Manufacturing facility plan
Clarion III – API
Facility
Clarion I – FDF
Facility
Clarion II – FDF
Facility
Area for new plant
Claris Otsuka Limited (JV)
19
CLARIS INJECTABLES LTD – PLANT OVERVIEW
Overview of manufacturing operations
Clarion I – FDF Facility
Clarion II – FDF Facility

14,400 square metres

13,145 square metres

Aqueous, emulsion

Aqueous, lypholised

Bags, vials, ampoules

Ampoules, vials

5 lines

4 lines (2 lines already in place)

115 million units (2014)

200 million units (2014)
Key Regulatory
Approvals
FDA, MHRA, TGA, ANVISA

MHRA approved


FDA (Audit Expected early 2017)
Peak Revenue

INR 600 Cr with two Lines


INR 1000 Cr with Four Lines
Manufacturing Area
Clarion III – API Facility


Capabilities
Capacity
INR 900 Cr

4,100 square metres
API production for:
– Iron Sucrose
– Hydroxyethyl Starch
– Dexmeditomidine
FDA-approved
20
CLARIS INJECTABLES LTD – TECHNICAL CAPABILITIES
Strong R&D and regulatory capabilities
Key Facts

55 highly qualified employees across R&D, F&D and analytical development

Strong expertise in products in PVC/PVC-free bags and fat emulsion technology

32 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.$5 billion market opportunity in the regulated
markets

39 highly experienced employees in regulatory affairs

402 registrations currently
Registrations
Products*
US, 13
Europe,
76
Emerging
Markets,
271
402
ORM, 42
38
18
17
Europe
Other Regulated
Markets
8
US
Emerging
Markets
*1 Product equals 1 Molecule. Molecules do not add to 51 in total as some are in multiple geographies.
21
CLARIS INJECTABLES LTD - QUALITY
Strong focus on quality
Manufacturing & Quality Manpower ration: 1: 1.12

Laboratory area spread over 1,250 sq. metres

Dedicated quality control and quality assurance for all plants

All quality control tests conducted in-house

Ongoing quality system upgrade programmes through internal and external resources

Separate dedicated stability department

Systems complying CFR 21 for all equipment

Uniform quality assurance system for all markets
307
Quality
Headcount
275
Manufacturing
Headcount
State-of-the-art Equipment from World Renowned Suppliers
22
Products (Key Growth Driver)
23
KEY PRODUCTS – US MARKET
USA - Pipeline Launch Profile

Business poised for significant growth from an attractive and unencumbered pipeline

Targeting a portfolio of 100 products in USA
ANDA Approvals per year & US Market Size (USD Mn) - *projected pipeline is subject to FDA approval
New ANDA Approvals
Market Size(USD Mn)
3916
4000
160
3500
140
2773
120
1935
27
80
60
0
1293
6
3
807
40
20
1212
297
14
22
CY2017
8
297
Under Approval
23
1463
Under
Development
56
2156
Total
87
3916
2000
16
1000
500
0
CY2016
Approved
1500
13
Registered
Est. Mkt. Size
(USD Mn)
3000
2500
100
Molecule
Product Segment
CY2018
CY2019
CY2020
2021+
24
Strong Pipeline of products awaiting approval from the FDA
45
297
388
543
803
2031
40
35
13
30
4
25
39
20
9
15
10
13
5
0
Approved
CRL Responded
CRL Received
ANDA Status
Under Approval
TOTAL
Mkt Size
US$ mn
25
USA – Recent GPO Contracts
GPO






(Includes MedAssets &
Novation)



(Intalere)
Award Type
Total Contracted
Value ($mn)
CIL Projected
Contract Value ($mn)
Metoprolol
Norpinephrine
Sole and Dual
20.2
16.8
Sole, Dual and
Multiple
30.1
9.0

Metoprolol
Metronidazole
Norpinephrine
Ondansetron

Norpinephrine
Dual
1.9
1.0
Norpinephrine
Metoprolol
Dual and
Multiple
26.2
11.1
78.4
37.9
Product




Ciprofloxacin
Fluconazole
Furosemide
Levofloxacin


Ciprofloxacin
Fluconazole
Furosemide
Levofloxacin



Fluconazole
Metronidazole
Ciprofloxacin
Fluconazole
Furosemide


Total
In addition to the above, there are other Off Contract and direct sales to Customers.
26
KEY PRODUCTS - PROPOFOL
Anesthesia & Propofol Market Growth
Propofol – key facts
700
Market Size at CIF Prices (US$ mn)
503
600
500
400
300
145
575
235
281
344
2011
2012
2013
202
0
2010
Other Anesthesia
EU & ORM
EM
Global
Claris Region wise sales of Propofol – FY16 (Rs. mn)
246
120
116
246
US
222
200
100
184
355
318
590
Propofol
Leading Market Position
 The only emerging market player to have approval and
commercial sales in regulated markets
 Over 8 years of experience in manufacturing and marketing
Propofol in regulated markets
627
1,389
762
 Approval in 86 countries with commercial sales in over 50
0
US
Capacity
Market Size
 Over 100 million units sold globally
countries in 2013. Filing in the US
EU & ORM
EM
Global
 Capacity to meet c.25% of the Regulated
market requirements
 Global market size of c.US$900m
 US market size of c.US$245m with a 2010-2013
historical CAGR of c.29%
 Well established global distribution network
Competitive Strengths
 India cost advantage
 Economies of scale
27
KEY PRODUCTS – IRON SUCROSE
Leading Market Position
Market Size at CIF Prices (US$m)
 FDA-approved own manufacturing of API along with finished
32
formulation
32
223
 Manufacturing capabilities in ampoules & vials
159
US
 Strong international footprint
 The only generic player in many countries incl. Brazil and South
EU & ORM
EM
Global
Claris Region wise sales of Iron Sucrose – FY16 (Rs. mn)
Africa
 Clinical data to establish B.Eq. with the innovator product
Iron Sucrose – key facts
Market Size
0
17
US
ORM
239
256
EM
Global
 Global market size: c.US$530m
 US market size of c.US$320m with a 2010-2013
historical CAGR of 8%
Competitive Strengths
 India cost advantage
Capacity
 Capacity to meet c.28% of the Regulated
market requirements.
 Economies of scale
28
Corporate Practices
29
REWARDS & RECOGNITIONS
Well-Recognised Pharmaceutical Company

For 6 consecutive years - India’s Best Companies to Work (2010 -2015) - The Economic Times & Great Place to Work (R) Institute, India.

India Innovative 100 – Inc. India
Asia Pacific Entrepreneurship
Award - 2016
In-House Communication
Excellence Award 2014
Global HR Excellence
Awards - 2016
Merit Award 2014
SPC, Sri Lanka
India’s Best Companies to Work
(2010-2015)
Certificate of Excellence for
smart innovation - 2013
Greentech HR Excellence
Awards -2010
30
HR BEST PRACTICES
Talent development and retention strategy
Induction & Learning


Capability Enhancement Programs (Trainings)
Induction & Orientation programs:

–
Functional overview
–
Managerial Leadership Programs
–
Manufacturing campus visit
–
Managerial Executive Programs
–
Sessions by senior management
–
External trainings at prestigious institutes
–
Product
– IT training
Learning & knowledge enhancement through international
trips, and sponsorships to seminars/conferences
Performance Review Policies




Behavioural programs and trainings:

Functional trainings
–
Capsule courses – pharmacy, engineering, dossier
preparation, finance for non-finance managers
Career Planning & Progression
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

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
31
HR BEST PRACTICES
Improving the quality of living for employees
Festival Celebration
Activities


Organization of sports competitions

Organization of cultural activities and welfare campaigns

Dedicated area for playing indoor games with fitness and
Celebrations of functional achievements & traditional festivals
recreation including air hockey, basketball nets, boxing
bags and darts
Talent Shows & Special Days Celebration

C–Bash (Creativity Bash unveiling hidden talent in music, plays, etc.)

Independence Day, Women’s Day, Christmas, Diwali
32
Financial Plan
33
CLL – CORPORATE STRUCTURE
Indicates Speciality Injectables
Business (SIB)
(Before 1st Apr 2016)
Claris Lifesciences Ltd (CLL)
20%
100%
Claris Otsuka (P) Ltd
(COPL)
(CIL)
Claris Venture Capital Ltd
(CVCL)
CLL ME
Claris Pharmaservices
(CP)
ELDA
USA
PHILIPINES
AUS
UK
(2nd Quarter 2016 onwards)
Claris Lifesciences Ltd (CLL)
100%
20%
(CIL)
USA
AUS
Claris Otsuka (P) Ltd
(COPL)
Claris Venture Capital Ltd
(CVCL)
CLL ME
Claris Pharmaservices
(CP)
ELDA
IP Holding – US & ORM
IP Holding – EM
UK
PHILIPINES
34
FINANCIALS - SPECIALITY INJECTABLE BUSINESS P&L
(VALUES IN INR Cr.)
Particulars
FY16
FY15
Growth%
Net Sales
621
447
39%
EBIDTA Pre R&D
200
177
13%
35
31*
EBIDTA Post R&D
165
147
EBITDA Margin (%age)
26%
33%
70
120
0
(52)
R&D
PAT
Effect to PAT due to deferred tax
PAT reduction if R&D was expensed
Revised Comparative PAT
PAT Margin (%age)
12%
(42%)
21*
70
47
11%
11%
49%
* Management representation of R&D Expenses that was capitalized during FY15
•
Revenues for SIB grew by 39% for FY2016 vs FY2015
•
Post R&D EBITDA for the year grew by 12% as compared to the previous year.
•
EBTIDA Margin for the year has dropped to 26% as compared to 33% due to expansion of management overheads and absorption of CL2
fixed overheads.
•
Comparative PAT has grown by 49%, while the margin has remained flat. YoY Reported PAT has de-grew by 42%, but provided above is a
comparative PAT after taking the effects of (i) one time deferred tax reversal and (ii) if R&D would have been expensed out last year as well.
35
FINANCIALS – CLL CONSOLIDATED P&L
(VALUES IN INR Cr.)
Particulars
FY16
FY15
Growth%
Net Income
754
663
14%
Pre R&D EBITDA
221
204
8%
35
31*
EBITDA
186
173
EBITDA%
25%
26%
34
141
R&D
REPORTED PAT
Deferred Tax
(52)
R&D Expensed Adjustment
21*
Loss from Exceptional Item (Q2 FY16)
38
Business PAT
72
68
10%
10%
Business PAT%
8%
6%
* Management representation of R&D Expenses that was capitalized during FY15
•
The company started expensing R&D for this financial year, so a like to like comparison has been provided via a management representation
of R&D of 31 Cr for the previous year.
•
We have provided a comparative PAT above represented as Business PAT. Which has taken into account the effects of (i) deferred tax of 52 Cr
in the previous year (ii) Exception Loss this year of 38 Cr this year and (iii) R&D being expensed out during the year.
•
EBITDA and PAT margins are subdued due to expansion of management overheads and absorption of CL2 fixed overheads.
36
FINANCIAL PLAN – FY17
(VALUES IN INR Cr.)
Margin
SIB REVENUE
SIB EBITDA
26%
24%
621
CLL PAT
30%
12%
39%
770
11%
18%
230
85
165
72
FY16 (A)
FY17 (P)
FY16 (A)
FY17 (P)
FY16 (A)
FY17 (P)
37
FINANCIALS – CLL CONSOLIDATED BS (Key Items)
(VALUES IN INR Cr.)
KEY DEBT RATIOS
Gross and Net Debt Status
DEBT:EBITDA
Working
Capital
Term Loan
Total
Loans in US$
78
315
393
Loans in INR
93
117
210
171
432
602
Particulars
Total
Cash & Equivalents
3.2
2.8
(397)
Net Debt
205
FY2016
Working Capital Cycle
FY2017 (P)
DSCR
1.75
Particulars
Trade Receivables
Inventory
Trade Payable
Net Working Capital
Value
Months
203
3.2
94
1.5
(103)
(1.6)
194
3.1
1.56
FY2016
FY2017 (P)
38
Thank You
E-Mail: [email protected]
Claris Corporate Headquarter I Nr. Parimal Crossing I Ellisbridge I Ahmedabad I India.

Investor Relations Presentation

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