Final Pharma First 3 Ppl

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    GROWTH OPPORTUNITIES IN

    PHARMACEUTICAL SECTOR

    Presented by

    Gayatri Limbachiya A-1OPriyam Mhashilkar A-23

    Pallavi Edakhe A-6

    Sheetal Pawar A-31

    Ashwin Soni A-47

    Farhan Siddiqui A-45

    Akhlaque Shaikh A-54

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    INTRODUCTION

    The Pharmaceutical Industry in India is one of the largest in the world

    By 2015 it is expected to reach top 10 in the world beating Brazil, Mexico,South Korea and Turkey

    The estimated worth of the Indian Pharmaceutical Industry is US$ 20billion

    Almost most 70% of the domestic demand for bulk drugs is catered by theIndian Pharma Industry

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    The growth rate of the industry is 13% per year

    Healthcare grew from 4 per cent of average household income in 1995 to 7

    per cent in 2005 and is expected to grow to 13 per cent by 2025

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    The Indian Pharmaceutical Industry is one of the biggest producers of the

    active pharmaceutical ingredients (API) in the international arena

    Indian bulk drug industry will expand at an annual growth rate of 21

    percent to reach $16.91 billion by 2014.

    Around 40% of the total pharmaceutical produce is exported

    55% of the total exports constitute of formulations and the other 45%

    comprises of bulk drugs

    There are approximately 250 large units and about 8000 Small Scale Units,

    which form the core of the pharmaceutical industry in India (including 5

    Central Public Sector Units).

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    PHARMA INDUSTRY STUCTURE

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    Active Pharmaceutical Ingredients (APIs) examples Orchid Chemicals,

    Elder Pharma etc.

    Formulationsexamples Sun Pharma, Cipla, Dr. Reddys etc.

    Contract Research and Manufacturing Services (CRAMS)Examples

    include companies like Divis Labs, Jubilant Life Sciences etc.

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    Export from India March -2011

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    CHANGING FOCUS IN CRAMS

    Contract research is increasing at the rate of 25% per year

    CRAMS sector to the level of $7.6 billion by 2012 from $3.8 billion a yearago

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    Contract Research Organizations(CROs) provides services including

    drug discovery, new product development, formulation, pre-clinical

    trial

    The main factors for the growth of the CRAMSHigh Number of USFDA and UKMHRA approved plants

    Well-developed chemistry skills

    Low production & R&Dcost

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    Under WTOs TRIPS Agreement(2005), Developing countries to provide

    product patents on pharmaceuticals.

    India decided to enforce a product patent regime since 2005, which banned

    copying and selling of patented drugs launched after 1995.

    This gave them confidence to take on global generic companies and went

    ahead to acquire numerous overseas units to enter newer markets

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    Biosimilars

    48% of global revenues of the top 100 drug

    will be from biomolecules by 2016

    Biggest product could be Humira rheumatoid

    arthritis drug in 2020

    Patented Biologicals costlier demand less,

    Companies keen on Biosimilar

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    Challenges

    Tougher to produce

    Manufacturing processes cant be altered

    cost of developing a biosimilar higher than

    chemical generics

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    Biosimilars in India

    15 epoetin, 4 insulin also other Anti Cancer

    Biosimilars

    Market estimated with CAGR 30%+

    Success Story: Dr Reddy's Reditux, biosimilar

    of Roche's cancer drug Rituxan

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    Mergers

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    Alliance and Partnership

    Research

    Co Develop Drugs

    buy or in-license molecules

    Manufacturing

    cost advantage

    highest number USFDA-approved plantsoutside US

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    Innovation DrivesPharmaceuticals Business

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    Stratified Medicine

    the move from mass market therapy to

    specialized therapies to treat smaller groups

    of patients

    Companies with great science and deep

    pockets are developing high tech compounds.

    Pfizers Xalkori (crizotinib)

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    Convergence Of Drug Device

    opportunity to combine the biological and/or

    biomechanical properties of drugs and devices

    e.g. direct in situ delivery of therapeutic

    agents

    It requires a highly specialized marketing and

    sales

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    Reviving Dormant Compounds

    a major growth opportunity lay in revisiting

    dormant compounds

    some companies are re-evaluating and re-

    visiting them

    opportunities in reviewing data, reviewing all

    aspects of past clinical data

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    E.g. Thalidomide

    approved by the Federal Drug Administrationfor treatment of leprosy

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    Embracing Change In Organization

    a shift in mind set hence in behaviours is

    needed in order to redefine success

    daring to propose and implement stepwise

    new ways of working, of competing should be

    part of a firms DNA.

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    CHALLENGES

    delivering affordable health care to India's

    billion-plus people

    the regulatory environment

    to create access to a reasonable quality healthcare for all

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    FUTURE PROJECTIONS

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    Divis laboratory Limited

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    Introduction

    Established in the year 1990

    Headquarters and Registered Office

    at Hyderabad

    four multi-purpose manufacturing facilities withall support infrastructure like Utilities,

    environment management and safety systems.

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    Fundamentals and strength

    As a Prime fundamental, focused on developingnew processes for the production of ActivePharma Ingredients (APIs) & Intermediates.

    Complete turnkey solutions to the domesticIndian pharmaceutical industry.

    With 5 years of experience, expertise and aproven track-record of helping many companieswith its turn-key and consulting strengths,

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    It undertakes custom manufacture of APIs andadvanced Intermediates offering a competitiveadvantage to its clients over the entire life cycle of

    the products.

    Transparency in operation

    Great benefit from Divis Research Center givesclients the advantage to concentrate on actualinvention

    Invested heavily in knowledge, equipment and man-power to expand in technology area which issophisticated, challenging and rewarding. Currently,Divis is a major manufacturer of protected amino-

    acids.

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    Stock Analysis

    Q1 Net profit up

    67% Y-o-Y to

    Rs167 cr

    Q4 net profit up24% Y-o-Y to

    Rs 216 cr

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    Key financial indicators

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    Financial Ratios

    Net Profit ratio : 28.57 %

    Expense Ratio : 63%

    Current ratio : 3.181

    Return on Asset : 25 %

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    About Sun Pharma

    Established by Mr. Dilip Shanghvi in 1983 inKolkata

    57% sales (US).

    fourth largest pharma company in India

    The company markets over 200 generics, withanother 150 awaiting approval from the USFDA.

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    Manufacturing is across 23 locations

    Canada

    U.S

    Mexico

    Brail

    Isral

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    A planned acquisition of Israeli Taro Pharmaceuticalsinitiated in March 2007 completed in Sept 2010.

    Acquisition via Alkaloida

    Sun's subsidiaries has stake in Taro to 66.5 per cent asper the deal

    Proposes acquiring remaining stake (33.5%) in Oct2011

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    1 Not interested in taking over

    Wockhardt: Sun Pharma

    2 Lupin's acquisition

    agenda for the future

    With Sun Pharma-Merck

    striking JV, why is SPARC

    shining?

    The good, the bad &

    the ugly of Q4

    earnings(12%

    increase442 cr)

    Sun Pharma to

    acquire Taro, to pay

    $367m for 33.5%

    stake

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    6 Wockhardt to

    conclude nutrition

    business sale by

    20127 Wockhardt to conclude

    nutrition business sale by 201

    8 Sun Pharma to

    acquire Taro, to pay

    $367m for 33.5%

    stake

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    Financial Analysis

    0

    500

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    2010 2011 2012

    PAT

    Operating Profit

    Income

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    Highlights

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    Reasons

    Sales in India were Rs. 19,334 million, down 6%.

    Caraco, Sun pharmas 75%

    us-base subsidiary

    Stopped manufacturing

    operations from June 2009

    Total Income

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    0.00

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    2,000.00

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    2010 2011 2012

    Total Income

    Total Income

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    0

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    2010 2011 2012

    R&D

    R&D

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    R&D

    Creating new molecules

    537 products

    Developed APIs in cost effective manner

    Anticancer ,steroid

    Generic formulation (nasal sprays , dose inhaler )

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    Initiated exports to Europe for the first time

    received 11 product approvals in Europe up to

    March 2010.

    Received approvals for eight APIs from various

    regulatory authorities; this took the total

    regulated market-approved APIs to 89 out of155

    Net Block

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    0

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    2010 2011 2012

    Net Block

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    0

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    40

    45

    50

    2010 2011 2012

    Earning Per Share (Rs)

    Earning Per Share (Rs)

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    COMPANY ANALYSIS:

    DRL

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    Company was founded by Dr. Anji Reddy.

    Pharmaceutical company global generics segment, API segmentand proprietary products segment.

    Reddys manufactures and markets a wide range ofpharmaceuticals in India and overseas.

    Co. has 190 medications, 60 API for drug manufacture, diagnostickits and biotechnology products.

    1st pharma company from Asia (except Japan) to be listed on NYSE.

    DRL d B t h i iti

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    DRL and Beta pharma acquisition DRL acquire 100% equity of the German drug major.

    Benefits to DRL DRL immediately got access to the generic market of germany.

    66% market in Europe was held by Germany.

    DRL gained strategic presence in EU.

    There was not much liability linked to this acquisition.

    Stock market, Jan 16, 06 1030, Feb 16,06 1260.

    Synergy

    Distribution

    Manufacturing

    Pipeline

    Branding

    Presence

    Size

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    DRLs acquisition of GSK's penicillin facility in US

    Completed the acquisition of Glaxosmithkline (GSK) oral penicillin facility

    in US on Nov10. The buy was in line with its strategy to scale up its generic business in

    North America.

    It also brought an opportunity to explore additional synergy with itsbusiness.

    Dr Reddys scrip gained 2.93% to end at Rs 1680 on BSE.

    DRL and Merck Serono announce collaboration to develop

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    p

    and commercialize Biosimilars

    DRL has been pioneer in Biosimilar space as launched 4 Biosimilarmolecules till date.

    The partnership with Merck Sereno expands DRLs presence in theBiosimilar space select emerging markets and enables partnershipglobally.

    With FDA guidance, any significant player in the field will need strongbiologics, development, manufacturing and commercialization

    capabilities. Merck Serenos & DRLs Joint expertise in these fields makes for a powerful

    global partnership.

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    DRL to acquire Octoplus pharma

    DRL announced to acquire Octopus pharma, a service based

    pharmaceutical company of Netherlands for 27.39 million in cash on 22October, 2012.

    DRL offered to acquire 100% of the issued and outstanding shares of

    octopus with a premium of 30%.

    DRL already got commitment from over 50% of share holders of Octoplus.

    Deal would help expand the companys expertise and scientific capabilities

    as DRL is aiming to build a research base in Leiden (Netherlands).

    DRLs New molecule

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    DRL s New molecule

    DRLs stock surged about 4% on announcement of encouraging phase III

    trials of an anti diabetic drug and tie up for manufacturing obesity

    management drug, Orlistat. DRL and its research partner, Rheoscience announced that the initial trials

    of phase III stage of its anti diabetic compound, Balaglitazone is effective

    in reduction of HbA1c.

    HbA1c test is carried out to test blood sugar levels and it is the first Indian

    molecule to reach this stage. The company will have to prove the superiority of its molecule over

    Pioglitazone, a $3 billion drug launched a decade ago in trial, if it is to have

    a commercial launch which is estimated to be 1 year from now.

    DRL is in a tie up with Indian Bio technology company Transgene Biotek to

    manufacture and market Orlistat, an obesity management drug.

    The market size from obesity management drugs accounts for $2

    billion worldwide.

    Molecule

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    Molecule

    Takeda filed patent infringement suit

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    p g

    Global pharma major Takeda Pharmaceuticals Ltd. had filed a

    patent infringement suit in New york court over the latters

    efforts to manufacture generic version of acid refluxtreatment drug Dexilant (Dexlansoprazole) in April 2011.

    According to Takeda, the 2 patents which it alleged Dr. Reddy

    infringed would expire in June 2020 & August 2026.

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    Crosses USD 2bn in

    revenuesFuji film & Dr. Reddy - JV

    Expands R&D centre in

    cambridge, UK

    Key Financial Trends

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    Key Financial Trends

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    Key Financial Highlights

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    Key Financial Highlights

    Rs in crore

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    Balance Sheet of Dr Reddys Laboratories

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    Balance Sheet of Dr Reddys Laboratories

    Mar 201212 mths Mar 201112 mths Mar 201012 mths

    Rs Cr

    Reserves 6,633.00 5,935.60 5,830.20

    Net worth 6,717.80 6,020.20 5,914.60

    Net Block 1,896.80 1,691.00 1,315.60

    Total Assets 8,251.20 7,465.00 6,477.80

    Ratios

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    Ratios

    Mar 12 Mar 11 Mar 10

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    Mar 12 Mar 11 Mar 10

    l

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    Financial

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    THANK YOU