The transformation into a global company - PróGenéricos Sharma - Lupin - The... · The...

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Dr Kamal Sharma Lupin: The transformation into a global company

Transcript of The transformation into a global company - PróGenéricos Sharma - Lupin - The... · The...

Dr Kamal Sharma

Lupin:The transformation into a global company

Contents

Current Landscape

The building blocks for being globally competitive

Lupin : A quick update

Lupin : Going forward

USA : 328 38 55Canada: 34 8 18

France : 50 5 10Germany : 68 24 31UK : 34 7 9

Italy : 35 1 2Spain : 28 2 4

Brazil : 20 2 4Mexico : 14 2 3

China : 17 15 24India : 09 07 13 Japan : 67 5 10

GenericsGenerics

CountryCountry IncInc CAGRCAGR

USA 17 8.0%

China 9 9.9%

India 6 13.2%

France 5 14.9%

Japan 6 14.9%

UK 2 5.2%

Canada 5 10.7%

Italy 1 12.5%

Spain 2 13.8%

Brazil 2 14.9%

Mexico 1 10.5%

Germany 7 5.3%

The Global Pharmaceutical Market: 2008 -2013 ($Bn)

Pharma Mkt 2008- $740 BnGeneric Mkt 2008- $122 BnGeneric Mkt 2013- $188 Bn

Source: Espicom’s World Generic Market Report 2007 & 2009

Market breakdown and penetration levels

Generic Penetration

63% 65% 64%44% 38% 38%

17%

37% 35% 36%56% 62% 62%

83%

0%10%20%30%40%50%60%70%80%90%

100%

USA

Germ

any UK

Fran

ce

Italy

Spai

nJa

pan

CountriesV

olu

me m

ark

et

share

Source: Espicom’s World Generic Market Report 2007 & 2009

Generic Retail Market Estimates USD Bn2008 Geographic Generics Market breakdown

Source : IMS Health, MIDAS, Market Segmentation, Rx only,MAT June 2008; 25 Market Segmentation countries

Japan

3.2%Poland

3.2%Spain

3.6%Italy

4.0%

Canada

6.0%UK

6.7%

France

7.1%

Germany

8.9%

US

44.8%

All Others

12.6%

Global Generics – Growth is slowing, gross margins declining

Source : IMS Health, MIDAS, Market Segmentation, Rx only,Dec 2008; 27 Market Segmentation countries

7.9%7.2% 6.8% 6.6%

10.0%

13.0%12.0%

10.0%

8.0%

2.5%

4.8%3.5%

0%

2%

4%

6%

8%

10%

12%

14%

2004 2005 2006 2007 2008 2009

Gro

wth

Pharma Generic

54.2

51.251

48

55.154.1

51.9

49.3

54.5

53.1

51.6

49.1

54.5

51.4

50.249.1

44

46

48

50

52

54

56

Q1 Q2 Q3 Q4

2005200620072008

Companies include: Actavis, Gideon Richter,Stada, Zentiva,Barr, Mylan, Cipla, DRL, Ranbaxy, Sun Pharma

Gross Margin declining over last Four years.

Drug Pricing Case Studies

• Citalopram:– Price Competition has reduced the price of Citalopram by 96% since first generic

launch in 2004

• Ciprofloxacin:– Prices fell by 95% in the first month following its generic launch. Produced by

circa 11 companies (2004)

• Simvastatin:– European market highly competitive. Market participants expect Simvastatin to

go down to 99% discount to brand price

• Irinotecan:– 9 players got approval. Drove down launch price to 7% of brand value within

weeks (2008)

However, whilst increasing number of competitors drive However, whilst increasing number of competitors drive down price, top players retain their market sharesdown price, top players retain their market shares

Big Pharma – Approach towards generics in recent times

Pfizer Pfizer

• Announced setting up of emerging markets unit

• Recent press reports suggest that Greenstone will commence producing the ex-Pfizer generic products

• Aurobindo (India) tie up

Sanofi AventisSanofi Aventis• Zentiva acquired, platform in Central &

Eastern European market• Already established generic presence

through Winthrop.• Shantha Biotech deal complementing

current vaccine portfolio to accelerate growth in strategically important emerging mkt

Glaxo Glaxo

• Strategic alliance with Aspen & Strides Arcolab

• Access to renewable, high quality and competitively priced source of branded pharmaceuticals

• Tie-up with DRL

Daiichi Sankyo Daiichi Sankyo

• Acquisition of Ranbaxy expands Daiichi Sankyo's business model from a primarily Japan focused innovator company to a global generics and innovator company

• Expands global reach from 21 to 56 countries with leading market positions

Brand Interest in Generics – The Strategic Rationale

Access to high growth marketsAccess to high growth markets

• Emerging markets currently largely (branded) generic in nature

• Entering new markets through alliances to access large portfolio and sales & distribution capability

Cost ContainmentCost Containment

• Access to significant assets at low cost countries can support reduction of mfg. costs, raw materials supply

• In addition, many emerging players offer increasing low cost capabilities in new drug development

Life cycle managementLife cycle management

• AG deals/settlements etc enable brand pharma to protect turf for a longer time

• Eg: Dr Reddy’s AG launches of Zocor® (Simvastatin) and Proscar® (Finasteride).

Future convergenceFuture convergence

• Potential for convergence between brand and generics around biologics development, manufacturing and marketing

Value of products going off patent expected to increase from 201Value of products going off patent expected to increase from 20100

Patent Cliff in Generics… Take off in Bio-similars post 2011

15 1619 18 15

31 4631

23 2325

2 1 4 2 0 4 611

21 2216

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

35 24 2233

27 45 34 3835 33

24

3 3 31

4 6 6 59 6

14

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Worldwide sales of expiring products in year of US patent expiry in $ Billions

Molecules coming off patent : number of molecules

Biotech products

Conventional products

Favorable tailwinds have helpedFavorable tailwinds have helpedgeneric growth thus far .. generic growth thus far .. • Record level of patent expirations

continue to drive growth • Generic penetration levels have been

different across geographies reflecting significant growth potential in several geographies

Headwinds are gathering forceHeadwinds are gathering force

• Price erosion to intensify given high competition

• Slow down in growth rates • Margin expansion increasingly difficult

Smaller players: act fast or dieSmaller players: act fast or die

• Limited ability to survive longer term if “me too”

– Acquire size– Differentiated products– Highly specialized formulations– Distinct geographies

Big Pharma is flexing muscles... Big Pharma is flexing muscles...

• Increasingly, Big pharma is licensing authorized generics to third parties.

• Generic companies seeing at least half of value potential disappear due to AGs

• Big Pharma taking over generic companies or looking at alliances

Reflecting on the Current Landscape

Contents

Current Landscape

The building blocks for being globally competitive

Lupin : A quick update

Lupin : Going forward

Six Levers For Long Term Competitiveness

Building scaleBuilding scale• Achieve cost economies • Balance market power of customer channel• Increased ability to pursue Para IV strategy, ‘at

risk’ launches• Market share creates effective barrier to entry

Market Consolidation, Geographic Market Consolidation, Geographic diversification & Alliancesdiversification & Alliances

• Key strategy to manage price /growth pressures• Leveraging pipeline• Diversify revenue streams/ regulatory risks• Alliances with key institutions ( universities,

research institutes) for greater innovation possibilities

Expand into niche generic areasExpand into niche generic areas• Niche generics offer better margins/less

competition• Going forward, Speciality therapies will be a key

differentiator.• Here too, ultimately vertical integration will be

required

Vertical IntegrationVertical Integration• Earlier access to APIs in order to attain FTF

status• Capture profits across the value chain• Provide critical ability to manage cost and

profitability through product life-cycle, allowing for first in- late out strategies

Emerging Branded Generic marketsEmerging Branded Generic markets• Acquisitions in key markets where organic growth

would be difficult• Alliances with key players across geographies,

therapies

BiogenericsBiogenerics• The final frontier for Generic Companies ..….

Large outlays & unclear regulatory pathways not withstanding

1 Building Scale brings in several benefits

Some dimensions of sizeSome dimensions of sizeNo. of products in the market-Broad PortfolioNo of products & rich pipeline for the futureGeographical spread of operationsGlobal supply chainR&D spendsAlliances in place

35% players control 65% of key market.Size begets size : Teva grew 10x in 10 yearsSize brings in cost leadership through economics of scale, muscle power in the market

Source: Goldman Sach’s Research

EBIT Margin of large vs small manufactures

0%

5%

10%

15%

20%

25%

30%

35%

1Q03

2Q03

3Q03

4Q03

1Q04

2Q04

3Q04

4Q04

1Q05

2Q05

3Q05

4Q05

1Q06

2Q06

3Q06

4Q06

1Q07

2Q07

3Q07

4Q07

1Q08

E2Q

08E

3Q08

E4Q

08E

Small Cap Large Cap

2 Vertical Integration

Strategy:Strategy:▶

As the market becomes commoditized, an increasing number of firms are focusing on enhancing vertical integration and cost competitiveness

Improves time to market

Enhances ability to react to price pressures by knowing and controlling internal costs instead of having to renegotiate with suppliers

Examples:Examples:▶

Fresenius acquisition of Dabur

Mylan acquired Matrix Labs

Actavis acquisition of Zhejiang Chiral Medicines company (China)

API producers like Aurobindo moving downstream into FDF

Increasing competition will make capturing the entireIncreasing competition will make capturing the entireValue chain a key to success Value chain a key to success –– Case study: FreseniusCase study: Fresenius

2 Vertical Integration

Source: Company Presentation

3 Niche Areas

Strategy:Strategy:▶

The previous focus on large value generics has created a treacherous commodity environment where profitability is low

Instead, harder to develop/ produce niche areas such as oncology, steroids, dermatology are providing higher margins and better sustainability

Examples:Examples:▶

Teva’s acquisition of Sicor (Oncology)

Hospira’s acquisition of Mayne ( Oncology)

Sandoz’s acquisition of Sabex (injectables)

Teva’s acquisition of Ivax (respiratory and oncology)

Sun’s entry into Controlled products

Rapidly changing market dynamicsRapidly changing market dynamics

Leverage pipeline & portfolio, target new growthLeverage pipeline & portfolio, target new growth

4 Geographical Expansion incl. consolidation in existing markets

Acquisition drive diversification Acquisition drive diversification

Strategy:Strategy:▶

The volatility of commodity markets are increasing the attractiveness of the branded markets

Companies are now increasingly focusing on those areas (which tend to be emerging market economies) such as Turkey, Russia, Romania, Poland, Latin America and India

The focus is both organic (Ranbaxy, Ratiopharm, Zentiva) and inorganic

Examples:Examples:▶

Teva’s acquisition of Barr and their footprint in CEE via Pliva

Stada’s acquisition of Hemofarm (Serbia) and Nihzpharm( Russia)

Polpharm bought Akrikhin

Zentiva’s acquisition of Eczacibasi (Turkey) and Sicomed ( Romania)

5 Emerging Branded Generic Markets

6 Follow-on Biologicals

Strategy:Strategy:▶

One of the bright areas in the generic sector is the potential for bio similars

Because of the technical hurdles for producing (and registering) these products, coined with their size, the bio generic sector offers significant potential upsides to firms willing to invest the enormous amounts required (likely in the $ 40-50 millions range)

Examples:Examples:▶

Teva/Lonza

Teva’s acquisition of Barr to gain steroid and enhance biologics

Novartis/Lek

Mylan/Biocon

Barr/Pliva

Sandoz

Substantial future opportunitySubstantial future opportunity

Substantial future opportunitySubstantial future opportunity

Follow-on Biologicals

The Generic industry should build critical skillThe Generic industry should build critical skill--setssets

Biologic formulation capabilities

Biologic manufacturing capabilities

Clinical Trial capabilities

Sales force capable of marketing these products since generic

biologics are unlikely to be deemed substitutable

Sufficient capital to invest in above as well as the scale in the

respective P&Ls to withstand the necessary incremental annual

costs

Contents

Current Landscape

The building blocks for being globally competitive

Lupin : A quick update

Lupin : Going forward

Lupin: A Quick Update

13123

1750320717

27730

38238

0

5000

10000

15000

20000

25000

30000

35000

40000

FY 05 FY 06 FY 07 FY 08 FY 09

Net Revenue (Rs. Mn) • Has grown into a transnational company with about 65% of its turnover from outside India.

• 82% of its business is from FDF. API set to come down with more of API being used for value added formulations

• Geographical diversification set in motion in the last two years. Acquisition philosophy predicated on the need to be in certain geographies of strategic interest where organic growth would be difficult. Prudence is the cornerstone of our acquisition philosophy though we are not unfazed by size of the transaction.

918

17302200

3336

5015

0

1000

2000

3000

4000

5000

6000

FY 05 FY 06 FY 07 FY 08 FY 09

Net Income (Rs. mn)

Note: Other Income excluded from the Income of FY07 & FY08

Contents

Current Landscape

The building blocks for being globally competitive

Lupin : A quick update

Lupin : Going forward

Advanced Markets

Whilst Emerging Markets would grow at a faster pace, the critical mass would still come from the Advanced markets. It would be imprudent to ignore these markets…

USA▶

Europe▶

Japan▶

South Africa▶

Australia

Building Scale and Niche Therapy FocusBuilding Scale and Niche Therapy Focus

USA

$16 $17$19

$24

$31$34

$38

$43$47

$52

$58

$64

20

6

12

26

29

1012

13

911 11 11

$0

$10

$20

$30

$40

$50

$60

$70

2002 2003 2004 2005 2006 2007 2008 2009E 2010E 2011E 2012E 2013E0

5

10

15

20

25

30

35

% G

row

th

US Generic Mkt ($bn) % Growth

US growth under pressure in near termPolitical landscape and customer consolidation

adding further pressure in the US

Customers are consolidatingCustomers are consolidating 90% of generic volume is sold to 12 90% of generic volume is sold to 12 customerscustomers

Remains the biggest pharma market butRemains the biggest pharma market but……

17

3011

12

10

10

5

0

11

06

0

22 21

2718

2002 2008

Others

Alberton's

Eckerd

Kroger

Wal-Mart

CVS

Rite Aid

Walgreens

7 retailers

78%

4 retailers

79%Source: Espicom’s World Generic Market Report 2007 & 2009

US Generics market share Evidence of price pressure in US – Annual % changeon basket of widely used generics (WAC)

Market Trends

0

10

20

30

40

50

60

70

2000 2001 2002 2003 2004 2005 2006 2007 Q1 2008

Ge

ne

ric

s R

xe

d (

%)

% Total Prescriptions Dispensed % Dollar

Pricing Pressure and rapid erosionPricing Pressure and rapid erosion

2000 – 2007 CAGR Prescriptions = 4.7%

2000 – 2007 CAGR

Dollar = 4.5%

7.8

16

7.1

-9.6

-0.3 -0.6-2.5

2.81.6

2.3 2.73.4 3.2 2.9

-15

-10

-5

0

5

10

15

20

2001 2002 2003 2004 2005 2006 2007A

ve

rag

e a

nn

ua

l %

ch

an

ge

Manufacturer's Price General Inflation (CPI-U)

Source: AARP, FDA

Lupin in the USA

Outperform the market• Drive growth with high-value new products• Differentiate from competitors with our portfolio• Maintain strong historical growth trend

Sustain branded portfolio – mitigate earnings volatility

Expanding the boundaries of generics• Differentiated products• Serving customers with high quality and top end supply chain metrics• Meeting demand of specialty business with full range of products

Branded ProductsBranded ProductsProducts supported by brands

Dedicated sales force to call on doctors

Price hikes as against price erosion

Specialty therapy areas

Valued ProductsValued ProductsDistinctive dosage / delivery form

Limited API supply

Difficult formulation, challenging to match bioequivalence

Paragraph IV patent challenges

Limited competition

Sustainable prices

Long-term value

Commodity ProductsCommodity ProductsUn-disseminated dosage/ delivery form

Multi-source API

Straightforward formulation

Limited legal and regulatory

Hurdles, clear patent expiration

Multi-player generic market,

>6 generic players on day 1

Up to 99% price erosion

USA

Speciality Business will Drive GrowthSpeciality Business will Drive Growth

Optimal Portfolio includes balance of all CategoriesOptimal Portfolio includes balance of all Categories

Pharmaceutical market in % terms Key dispensing influencerGeneric volume penetration

Japan

4 1

9

6

2 6

4

13

6373

17

3727

83

GenericsOriginators

R.O.W

R.O.E

S.A

Japanese government target and actions2012 target: = 30% generic volume shareActively promoting generics:Fixed Sum allocation system (DPC*)2008 Changes to prescription format:“Substitutable unless ticked”Pharmacy incentive for generics dispensing

DPC Hospitals

Pharmacies

Segment ProductsCNS CVS GI

Blockbusters {e.g. amlodipine in 2008}Easy substitutable products

{e.g. tablets and capsules}

Lupin in Japan

3

5.6

10

2007 2010E 2013E

Japan Generics Market. USD bn

Asthama

Gastro Intestinal

CVS

CNS

Others

The Generics Medicines Reality in EU A non single market

The rate of volume Market Share varies considerable throughout Europe due to different Generic Medicines Policy between European countries

- 40 – 65% UK/D/DK/NL- 10 – 15% and expanding rapidly in

Ptgl/Fr….but- 60 – 80% CEE- 10% stagnant (Spain and Italy)

• 27 pricing systems and P&R agencies

• 27 differing prescription and substitution cultures

• Differences in functioning of distribution channel

• Average realisations of generic medicines are lower in Europe than in USA. This is despite –– Lower volume share– Higher ‘operating costs’– More IP hurdles– Lack of single market environment

for generic companies in European markets

Market Environment for Generic medicines USA EU Japan

Generic Medicines as % of Total Pharmaceutical Volume 63% 42% 17%

Basic Product Patent Yes20 years

Yes20 years

Yes20 years

Data ExclusivityBlocks market authorization procedures for generics

5 years 8+2+(1) years 6 years

Patent ExtensionsSupplementary Protection Certificates, etc.

Yes14 years Max

Yes15 years

Yes upto 15 years

Bolar ProvisionRight to perform generic R&D before patent expiration

Yes Yes(but no correctly

implemented in all member states)

Yes

Immediate Generic CompetitionUpon Patent Expiration

Yes No(due to price & reimbursement

procedures in many member states)

NoGeneric

approval/NHI listings done twice

a year

Fees for Generic Registrations No Yes(between 80,000 –

120,000 Euros)

Yes$6553 for each

strength

Free Price Competition Yes No(not in most member

states)

No Re-imbursement

by NHI

Harmonized Regulatory and IP Requirements Yes No No

EU versus USA versus JapanEU versus USA versus Japan

Lupin in Europe

• Tailor made strategies for individual markets• DTM in UK, Scandinavia, Partnered play in France;

Acquisition in Germany• Potential acquisitions in certain parts of Eastern Europe,

Spain• Competitive strategies would encompass:

– Vertical integration– Differentiated products, richness of pipeline– Speciality business

Lupin Pipelines for Advanced Markets

Submitted Approved

USA 94 35

Japan 21 5

EU 53 22

ANZ 25 21

Attractive market dynamics

Fast growing economies with strong GDP growthDemographic changes Expansion of government healthcare coverageIncreasing purchasing power of growing middle class

Complex environment

Heterogeneous healthcare systemsDifferences in local regulatory environment and market accessInvestment in local infrastructureImproving IP environment

Emerging markets are a key driver today and tomorrow

Growth contribution of Emerging Markets is projected to be around 70% in 2013(1)

Emerging Markets will outgrow per-capita GDP

Growth in Emerging Markets will more than offset the diminishing U.S. growth contribution

Emerging Markets are expected to reach >$500bn by 2020, up from less than $200bn in 2008(2)

Strategic opportunity for sustainable growthStrategic opportunity for sustainable growth

Emerging Markets

Special Mention: India

• The domestic market is expected to grow 12.1% p.a. to $20Bn by 2015

• Lupin is well positioned to rise above the tide due to differentiated product and marketing policies.

• Focus on Lifestyle segments of CVS,CNS, GI, Asthma, Female health and Biosimilars.

Growth drivers for domestic

formulations

Consolidationleading to

better pricing power

Health Insurance

Product Patentregime

Population growth,

demographics and

urbanization

Increasingper capita income & higher

penetration

Key Growth DriversKey Growth Drivers

Lupin’s Emerging Market Thrust- mixture of acquisitions, partnerships and Joint ventures

Philippines, Market size : $2.5 mn, growing at 10%

• Generic Market $ 800 mn• Acquisition of Multi-care in 2008.• To be launch pad for Lupin’s products. • Current focus on OB, Pediatrics, GP:Rx to OTC

switch, Value added generics as line extensions• Build strategic relationship, in-licensing of

products, expand basket of products and hospital range

South Africa• Acquired Pharma Dynamics.• $2.5 Bn mkt growing 13.5% generic mkt $900 Mn

growth 22%• Emergence of national health insurance for all

Compulsory generic substitution implemented by legislation

• Innovative MNCs entering Generic space• Focus area: CVS, CNS, Gastro, OTC’s • Future Growth Model: VAG, Patent Challenges &

Public sector tenders

Vietnam, Malaysia, Myanmar (through Partnerships)

• Malaysia $600mn, Focus area Cephalosporin, Anti- TB

• Vietnam $923mn focus on brand business of TB & Cephalosporin

• Myanmar $105mn, focus Cephalosporin

• Future plan of action: to include CVS and Analgesic segments in all countries. Higher focus in respiratory in Vietnam & Myanmar

Nigeria & Algeria

Nigeria• $700 mn market growth >10% unstructured and

unorganized • Lupin’s focus being Anti malarial OTC, Respiratory

including AsthmaAlgeria• $1.5Bn mkt 80% of population covered under health

insurance • Market growing at 50%• Strategy : Anti TB, hospital products, VAGs

Lupin’s Emerging Market Thrust- mixture of acquisitions, partnerships and Joint ventures

Brazil.• Largest in LATAM $ 13bn

• Private prescription market $10.5 bn growing by 18% for last 5 years

• 360- Pharma players- 60 MNC & 300 National

• MNCs- 65% mkt share & Top 40 Cos- 85% mkt share

• Tapping profitable mkt of women health care through a JV with a local player

• Exploring niche products opportunities through direct business with Dept. of Health (DoH)

Mexico• Total market size $14.2 bn

• Private Trade $9.7 bn – Ethical $7.8 bn, OTC $1.8bn

• Innovator – 60%, branded – 30%, Generic – 10%

• Market for generic is rapidly expanding

• Govt./ institutional $3.5 bn

• Private label mkt $1bn

• Future Focus- Tap GP & Pediatric segment, VAGs, in-

licensing

Gulf Co-operative Council

• Mkt size $4.8 bn • Dominated by innovator companies• Pricing reference – previous generic prices• Prior approval in US/EU before filling in GCC• Institutional business – price preference for local mfgrs• IP not transparent• Strategy- Acquisition of “Ready to Go’ Mfgr Business• Focus on few key segments• Supplement with acquisition /in-licensing of brand

business & new products

Central & Eastern Europe• CEE countries mostly have higher levels of profitability

and are attracting a number of new entrants to CEE region.

• Only a relatively small number of CEE markets are large enough to be very attractive investments locations.

• The following 7 markets are worth serious consideration of which 4 highlighted are for Lupin DTM operations;

– Russia - The Czech Republic– Poland - Hungary– Turkey - Romania– Ukraine

• Market entry will be through acquisition, Joint Venture or Greenfield start-up depending upon the country.

Lupin and Speciality Business

• Oral Contraceptives

• Ophthalmology

• Asthma

• Bio Similars

Vertical Integration Strategy: API

• API division is the Indian Industry leader for active pharmaceutical

ingredients (API) for generics

• Scale and technology driven market (not just market driven as in FDF)

• Manufactures approx. 80 % of Lupin’s finished pharmaceutical product

businesses requirements. Restrictive sales to third parties

• Provides Lupin with strategic advantages through vertical integration

– A major source for Lupin’s R&D and finished products

– Provides Lupin a strong competitive advantage – capital expenditure, strong IP

and leading worldwide expertise make Lupin’s API capabilities hard to replicate

• 4 production sites located in India

Research & Development

Lupin Research InfrastructureLupin Research Infrastructure

• Over 600 Research and Development scientists• Expenditure: 7% of sales and growing• Strong API Synthesis Capability• Complex and Niche Formulation Development

Capability• In-house BA/BE Studies Capability (At Lupin

Bioresearch Center)• Strong Intellectual Property function

Novel Drug Discovery and DevelopmentNovel Drug Discovery and Development

• Clinical development programsAnti-migraineAnti-psoriasisAnti-TB

• Pre-clinical programsMetabolic disordersCNS disorders

• Necessary infrastructure is being further strengthened and skill sets enhanced

Developing Products for Global MarketsDeveloping Products for Global Markets• Generics for Advanced Markets

(US, EU, JP, AU, CAN, SA)• Products for ROW & IRF markets• Products for WHO• New IP-backed Products (Branded, ADDS-based)• New Specialties

Steroids (Oral Contraceptives)

OphthalmicAsthmaBio-similars

ADDS Technology PlatformsADDS Technology Platforms• Bio-adhesive ER oral solids• Laser-drilled ER oral solids• Improved Bioavailability

Solubilization (Co-solvents, Surfactants, Lipids - SMEDDS)Particle Modulation (Nano-particles, API Co-crystals)

• Taste Masking for oral liquids• Inhalations (MDI/DPI)

Scaling and gaining critical mass

• Garnering market share in all markets,

becoming bigger and noticeable

• Portfolio going beyond standard generics

• Increasing share of products with some degree of

exclusivity

• Broad and deep, covering established and emerging markets

• Proven skills to adapt rapidly to changing environment

• Constant focus on high quality at lowest cost

Geographic Presence, organic/inorganic

Differentiation/niche products

Vertical integration & Operational Excellence

Replicating our Branded business model in new markets

– Developing our specialty business, bio-similars

– Focusing the US business on more specialised products

– Strategic investments in APIs will support growth across all businesses

Targeting doubling of sales growth every 4 years while improving operating margin

Lupin: Summary of Strategies

Consolidation in existing markets

• Consolidate through acquisitions in Japan, USA, India

Increased Focus on Bio Similars

Proven Capabilities Across the Value Chain

Sourcing

Execution Skills

Innovative sourcing of products, RM

Regulatory

Manufacturing

Marketing and Sales

Executing trials/projects at low cost

Experience in working with regulators

First class capabilities , Synergies leveraging expertise of Generic R&D

Proven strategies that drive market share, highly –productive sales force

Product Identification Differentiated products , Successful litigation experience

Being present in key markets around the globe

• Lupin sees itself as a transnational with sizable presence in various geographies of strategic interest

• These would be a mix of branded generic and INN markets

• Whilst geographical diversification would involve acquisitions, it would be based on prudence- ‘buy at a cost and not at all costs’.

Lupin :the road ahead

Challenges & Imponderables

• Challenges common to all

generic players – the

changing landscape

• Challenges of scale, growth

• Integration of subsidiaries

• People challenges

Near- Medium Term Value Creation

Generics

BrandedProducts

Medium-Long Term Value Creation (Proprietary Products)

Thank You