Cadila Healthcare Limited: Investor Presentation

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Cadila Healthcare Limited

Investor Presentation
May 2016
Well integrated pharma player with global footprints

> 60 years 9th largest 1st Indian Company


Generic co. in US in To discover & develop an
Operational experience terms of prescriptions NCE in-house : Lipaglyn
(Saroglitazar)

~ $ 1.5bn Among top 5 1st Company


Pharmaceutical To launch biosimilar of
Global Revenues Adalimumab anywhere in
companies in India
the world

>16% CAGR 15 brands 20 Biosimilars


In global revenues and Among top 300 brands in In pipeline, including 6
net profits (FY11-FY16) India novel biologics

~20% CAGR 19,000+ employees 1190 patents


In net worth Across the globe, with
(FY11-FY16) ~1200 for R&D Filed globally

~ $ 4.9 bn 25+ mfg. sites 8 R&D Centers


Producing > 15bn pills For NCE, APIs, Generic
Market Cap formulations, Biosimilars
annually
and Vaccines
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Track Record of Value Creation
INR Bn.
which gave us
Total Income
from significant external
Operations recognition

INR Bn. CII


Industrial
Net Profit Innovation
Awards
2015

INR Bn.

Market CNBC
TV 18
Capitalisation India
*
Innovator
Award 2013

3 * Market Capitalisation is calculated by applying the closing price of the financial year.
Key businesses for ZyNext journey

Zydus

Formulations Business Other Businesses and Emerging


Key Markets Alliances Businesses

US EU Formulations Biosimilars
India Consumer Vaccines
Latin America Wellness NCEs
Emerging Markets Animal Health
Asia, Africa APIs
JVs & alliances

High, Stable growth High upfront


sustainable & investments
Low investment
profitable
Large potential
growth
upside

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Key Financial Numbers FY 2015-16
Consolidated (Rs. Mio.) Amount Gr.% Segment-wise Gross Sales *
Total Income from Operations 98,376 13.7%
India Form.,
EBIDT 23,829 35.7% 31%

JVs ,5%
EBIDT % to Income from Ops. 24.2%
APIs, 4%
Profit before tax 21,236 46.9% Animal
Health, 3%
PBT % to Income from Ops. 21.6% Wellness, US Form.
5% 42%
Net Profit 15,226 32.3% EU Form.,
3%
EM Form.,
Net Profit % to Income from Ops. 15.5% Latam Form.,
5%
2%
R&D Spend % to Income from Ops. 7.7%
Other Businesses Form. Business -
Debt net of cash (as at 31-Mar-16) 17,467 and Markets, Key Markets,
20% of total, 80% of total,
Capex (FY 2015-16) 9,477 Up 1% y-o-y Up 15% y-o-y

* Gross Sales = Rs. 96,597 Mio.

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US formulations 9th largest generic player (based on scripts)

Market size* : ~$ 68 bn Aspirations


Market growth* : 4%+
Zydus size** : ~ $ 614 mn Be amongst the top 10 generic cos. in US with continued
strong focus on customer needs
Zydus growth** : 10%
One of the significant contributors to revenues and profits

24% CAGR in Sales (Last 5 years) Strengths to be leveraged


Gross Sales (USD mn) Sale of generic oral solids and injectable products
614
557 Strong sales and marketing base long-term relationships
with large whole-sellers & retail chains
Cost efficient manufacturing and supply chain
366
277
Robust regulatory pipeline - 265+ ANDA fillings, 100+
260 approvals
Alliance with AbbVie for sale of authorized generics (AGs)
70+ products launched so far (incl. 8 AGs)
Among top 3 for ~3/4th of the products marketed in US
2011-12 2012-13 2013-14 2014-15 2015-16
Ranked 9th among US generic companies based on
scripts (Source : IMS).

* Approx. numbers as per IMS MAT March 2016 Report


** Zydus numbers include that of Nesher and Hercon, as reported in books, for FY 2015-16
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US formulations strong product pipeline
Growing Focus on Complex Generics

Modified Release Oral Solids


Immediate Release Oral Solids
Transdermals
Injectables
Topicals
Controlled Substances
Nasal Sprays

Total Approved ANDAs 103(1) Total ANDAs Pending Approval 166


As on March 31, 2016 As on March 31, 2016

1. Including tentative approvals.


61 Para IV filings pending approval.
* Incl. Oral Suspensions (3)
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India formulations 4th largest player

Aspirations Market size* : Rs. 980 bn+


Market growth* : 13%
Leadership in CVS, female healthcare and pain mgt. area, Zydus size** : Rs. 41 bn+
among top 5 players in GI, respiratory and derma Market Share** : 4.25%
Continue to be one of the significant contributors to Zydus growth** : 12%
revenues and profits

Strengths to be leveraged Key therapies : ~66% of total sales#


One of the largest market players with leading positions in
key therapy areas

Strong brand equity : 15 brands among top 300 in India


New product launches : > 40 during FY 2015-16 (incl. line
extensions), with 10 First-in-India

Alliances with global players for new product launches


Sovihep (Sofosbuvir)

First company in the world, which launched CVS = Cardiovasculars


GI = Gastro Intestinals


Respi = Respiratory
Lipaglyn (Saroglitazar in Q2 FY 14), the first NCE FHC = Female Healthcare
Derma = Dermatology
discovered and developed by an Indian company AIs = Anti Infectives
Neutra = Neutraceuticals
Exemptia (Q3 FY 15), worlds first biosimilar of Neuro = Neurologicals

Adalimumab, the worlds largest selling therapy

* All market related information sourced from AWACS MAT-Mar-16


** Zydus numbers including Biochem as reported by AWACS MAT-Mar-16
8 # Sales of branded formulations in India for FY 2015-16.
Latin America formulations
Aspirations : To establish strong base with aggressive product launches
Brazil Presence in branded generics and generic generics segments with a
continued focus on brand building initiatives

Robust product pipeline from India - 95 filings, 40 approvals


Mkt. Size* :
~ BR$ 78 bn. Focused segments (Branded) female healthcare, hepatology, CNS,
Mkt. Gr. : ~ 14% CVS, Nutraceuticals and Pain Mgt.

Product launches : 25+ branded, 20+ generic generics

Mexico Focus therapy area (Branded) CNS


Building product pipeline from India 40+ filings and 35+ approvals so
Mkt. Size* : far
~ US$ 9 bn.
Mkt. Gr. : ~ -11% Commenced commercial operations in 2013 with launch of first product
from India
In overall Latin America : Launched 16 products in the market so far.
Zydus Size** :
Rs. 2,177 mn
Zydus growth** : 24% in
constant currency

* Approx. numbers of Brazil as per IMS MAT March 16 Report and approx. numbers of Mexico as per KNOBLOCH MAT March 16 Report
** Zydus numbers as reported in books, for FY 2015-16
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Emerging Markets formulations

Market size* : ~ $ 13 bn
Aspirations
Market growth* : ~ 12-13% To strengthen the position in different markets of
Zydus size** : Rs. 4,760 mn Asia and Africa
Zydus growth** : 17%
Strengths to be leveraged

Operations in different markets of Asia Pacific and


Africa and Middle East region with leadership
position in several of these markets.

Focus on brand building initiatives and


strengthening branded generics portfolio to ensure
sustainable growth in topline and bottomline.

Increased product development activities supported


by strong regulatory teams.

Commenced biosimilars business in emerging


markets by launching the first biosimilar viz.
Pegihep in FY 2015-16.

* Approx. numbers as per EvaluatePharma for emerging markets


** Zydus numbers as reported in books for FY 2015-16

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Other businesses (1/2)
Aspirations : To be a relevant player in generic markets of France and
EU formulations Spain

Mkt. Size* : ~Euro Among top 10 in France, among top 20 in Spain


Mkt. Size* : ~Euro+5.4
5.4 bn (France
bn (France + Spain Gx) Expansion through new products : launched 145+ molecules in France and
Spain Gx) 105+ molecules in Spain so far (incl. several Day 1)
Mkt. Gr. : 2.5%
Mkt.
ZydusGr.
Size: 2.5%
**:
Zydus
Rs. 2,956 mn**:
Size Leveraging India cost advantage : 200+ new products and 65+ site transfer
Rs. 2,956
Zydus mn
Gr. : -12% filings so far, >50% of sales supplied from India
Zydus Gr. : -12%

Consumer Wellness Aspirations : To create niches in wellness space through innovation

Leadership in sugar substitutes (~94% market share), peel-off and scrub


Zydus Size **: range for skin-care and margarine category in India
Rs. 4,570 mn
Zydus Gr. : 3% Recently re launched EverYuth face wash range with fresh, new and
contemporary looking packaging.

* Approx. numbers as per GERS and IMS Report for Europe.


** Zydus numbers as reported in books for FY 2015-16

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Other Businesses (2/2)

Animal Health Aspirations : To be a comprehensive, global animal healthcare provider

One of Indias leading animal healthcare players.


Acquired select brands and manufacturing operations in India from Zoetis, a
Zydus Size *:
global animal healthcare company so as to expand business in India
Rs. 3,169 mn
Zydus Gr. : 3% Presence in key markets across Europe, South America, Asia and Africa through
Bremer Pharma, Germany

APIs Aspirations : To be a reliable service provider to customers

Backward integration capabilities to meet captive API requirements


Zydus Size *: Operations in India, US and select markets of Europe, Latin America, Asia
Rs. 3,647 mn Pacific and Middle East regions
Zydus Gr. :-2% Continuous endeavour to improve service levels by improving cost
competitiveness and continuous process improvement

* Zydus numbers as reported in books for FY 2015-16.

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Joint Ventures and Alliances leveraging strengths

Aspirations : Value creation through win-win alliances and be a partner of choice

Zydus Takeda JV Zydus Hospira JV

State-of-the-art mfg. facility for APIs of Takeda State-of-the-art cytotoxic facility approved by
leading authorities like MHRA, USFDA, TGA,
Commissioned the expanded facility to
Health Canada
manufacture complex high-end APIs
Commercial supply of 10 products for EU
Commercial supply of 10 products (incl. 2 for
market and 7 products for US market.
validation)

Bayer Zydus JV Alliances with other partners

Operates in female healthcare, metabolic 26 ANDAs filed for various partners, 14


disorders, diagnostic imaging, CVS, diabetes approved,11 commercialised.
and oncology segments in India
Received the first NDA approval from US FDA
Leveraging strengths of Bayers optimised which was filed on behalf of a partner.
product portfolio and Zydus marketing and
distribution capabilities Commercial supply of 14 products so far under
JV scope covers launch of innovator products the out-licensing deal with Abbott
of Bayer

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Strong focus on R&D

Capability : target identification, pre-clinical


research and early clinical development
250+ dedicated scientists
NCEs 5 NCEs in pipeline
Launched Lipaglyn, the first NCE of India

600+ dedicated scientists for 70+ dedicated scientists


development of generics for Strong pipeline : 14 biosimilars
global markets and 6 novel products
Filed complex dosage forms like Generics
Bio- Launched 8 products so far (all 8
transdermals, topicals and develop-
similars in India,1 in EM)
nasals ment 1st co. to launch biosimilar of
295 US ANDAs filed (incl. 26 for Adalimumab in the world
partners), 117 ANDAs approved R&D at Strong IP position

so far
67 Para IV filings
Zydus

60+ dedicated scientists


13 vaccines under clinical development
~200 dedicated scientists for chemical API Received marketing authorization for 2
process development of complex and process Vaccines vaccines, launched 1 of them in India
differentiated APIs research First Indian company to launch
122 US DMFs filed so far indigenously developed and manufactured
H1N1 vaccine VaxiFlu-S (in 2010)

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Biosimilars and Vaccines emerging businesses
Aspirations : Leverage technological edge to unlock substantial value and create pillars for
future growth.
Strengths to be leveraged Biosimilar pipeline
Pre- Regulatory Mktg.
Biosimilars No Product Indication Cloning
Process
Devp.
Clinical Permissio
Clinical
Devp.
Authori-
Dedicated facilities for bulk and Devp. n sation
1 G-CSF Oncology
finished formulations 2 Peg G-CSF Oncology

70+ experienced scientists 3 IFN a -2b Infectious diseases


LAUNCHED
4 EPO Oncology/Nephrology
Strong pipeline: 14 biosimilars 5 Teriparatide Osteoporosis (in India)
and 6 novel products 6 Adalimumab Inflammation

Strong IP position either through 7 Trastuzumab Oncology


8 Peg IFN a -2b Infectious diseases Launched in India and EM (Myanmar)
own patent or non-infringing 9 MAB 1 Oncology/RA
processes 10 MAB 2 Oncology
11 Prod 1 AMI
Vaccines
Dedicated R&D and mfg. facilities Prod 2 Fertility
12

13 MAB 3 Rabies

60+ experienced scientists 14 PEG-EPO Nephrology


15 Prod 3 Oncology
13 vaccines under different 16 MAB 4 Osteoporosis
stages of development 17 MAB 5 Oncology

Received MA for 2 vaccines in 18

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Prod 4
Prod 5
Oncology
Oncology
India, 4 vaccines submitted for Complement
20 Prod 6
MA mediated disease

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NCE Research
Aspirations : Add more NCEs in pipeline to drive towards becoming a research based
pharma co. by 2020

Key strengths NCE Pipeline


Pre-
State-of-the art research facility Drug
Lead
clinical
Project Target Indication optimi- IND Phase I Phase II Phase III NDA
Discovery Develop-
Capability of target identification to saiton
ment
pre-clinical research / early clinical Saro-
PPAR-a,g Dyslipidemia First glitazar to be approved in the world. Launched in India as "LIPAGLYN"
glitazar
development
Saro- Hypertrigly-
First glitazar to be approved in the world. Launched in India as "LIPAGLYN"
250+ scientists dedicated for NCE glitazar
PPAR-a,g
ceridemia
research Saro-
PPAR-a,g Lipodystrophy
glitazar
Strong scientific advisory board Saro- Nonalcoholic
PPAR-a,g
comprising of worlds renowned glitazar Steatohepatitis
scientists, academicians and Saro-
PPAR-a,g
Type 2
glitazar Diabetes
clinicians
Saro- Hypertrigly-
PPAR-a,g Clinical trials going on in US
glitazar ceridemia

ZYH7 PPAR-a Dyslipidemia

DPP-IV Type 2
ZYDPLA1 Clinical trials going on in US
inhibitor Diabetes
HIF -
ZYAN1 Anemia Clinical trials going on in Australia
inhibitor
PARP -
ZYTP1 Oncology
inhibitor

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World class infrastructure to support ZyNext journey
Ahmedabad
Formulations
Oral Solids (Moraiya)
Oral Solids (SEZ) India U.S.
Topicals
Transdermal (SEZ)
Alidac Pharma (SEZ)
Lyophilised Inj. (Vatva) Sikkim
Biologics
Oral Solids and Gel
Bulk I
Consumer Wellness
Bulk II
Fill and Finish Baddi
Vaccines
Flu vaccine Haridwar
MMR vaccine (Animal Health)
Hepatitis vaccine
API
Oncology API Nesher 2 plants
(Controlled Substances Hercon
Consumer Wellness and Oral Solids) (Transdermals)
Nutralite Table spread
Brazil Germany

Goa
(Formulations)

Daman Ankleshwar
Dabhasa- API Baroda
Formulations API Ankl API Unit I (Injectable Formulations)
Biochem Unit I
Ankl API Unit II Zydus Nikkho Warburg, Bremer
Biochem Unit II (Formulations) (Animal Health)

Total facilities 30 (Formulations 16, APIs 4, Vaccines 3, Biosimilars 3, Consumer 2, Animal Health 2)

Total facilities inspected by US FDA 10 (Formulations 8, APIs 2)

Capabilities across delivery platforms Oral Solids, Controlled Substances, Injectables,


Topicals, Lyophilized Injectable, Sprays and Transdermals
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Key strategies for ZyNext journey

Strong execution focus for the U.S. market; drive growth with continuous focus on product
1
launches

2 Focus on difficult to develop and manufacture and specialty products to improve margins

In India, focus on high growth Therapeutic Areas, outperform the domestic market and
3 improve operational efficiency through increasing sales force productivity and
technological advancement

4 Leverage strong platform of biosimilars and vaccines business

Select inorganic growth to expand in India, U.S. and Emerging Markets, acquire capability
5
platforms and move forward in value chain on specialty and branded business

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Thank You.

Safe Harbour Statement

This presentation may include certain forward looking statements , based on current expectations, within the
meaning of applicable laws and regulations. Actual results may differ and the company does not guarantee
realization of these statements. The Company also disclaims any obligation to revise any forward-looking
statements . The readers may use their own judgment and are advised to make their own calculations before
deciding on any matter based on the information given herein.
No part of this presentation may be reproduced, quoted or circulated without prior written approval from Cadila
Healthcare Ltd.

www.zyduscadila.com

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