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Building a Global Generics and Specialty Powerhouse Nilesh Gupta Managing Director Lupin Ltd. August 25, 2014

Lupin Ndg Mosl 25 Aug 14

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Page 1: Lupin Ndg Mosl 25 Aug 14

Building a Global Generics and Specialty Powerhouse Nilesh Gupta

Managing Director

Lupin Ltd.

August 25, 2014

Page 2: Lupin Ndg Mosl 25 Aug 14

Disclaimer

Materials and information provided during this presentation may contain ‘forward-looking statements’. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and results to differ materially from these statements. Risks and uncertainties include general industry and market conditions, and general domestic and international economic conditions such as interest rate and currency exchange fluctuations. Risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited, to technological advances and patents attained by competitors, challenges inherent in new product development, including completion of clinical trials; claims and concerns about product safety and efficacy; obtaining regulatory approvals; domestic and foreign healthcare reforms; trends toward managed care and healthcare cost containment, and governmental laws and regulations affecting domestic and foreign operations. Also, for products that are approved, there are manufacturing and marketing risks and uncertainties, which include, but are not limited, to inability to build production capacity to meet demand, unavailability of raw materials, and failure to gain market acceptance. The Company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Page 3: Lupin Ndg Mosl 25 Aug 14

Index

Building a Global Generics Powerhouse 1

Lupin Update 3

Q&A 4

Building a Specialty Business 2

11

Page 4: Lupin Ndg Mosl 25 Aug 14

Section 1 Building a Global Generics Powerhouse

Lupin Ltd.

Page 5: Lupin Ndg Mosl 25 Aug 14

Critical Success Factors for building a Global Generics Company

Strong Market Presence in Significant Geographies 1

World Class Manufacturing 3

Stellar Execution Track Record 4

Excellent R&D and Regulatory Capabilities 2

11

Page 6: Lupin Ndg Mosl 25 Aug 14

Global generics landscape is poised to grow from $242b to $400b by 2016

Source; IMS market prognosis, May 2012

USA : 322 47 78 Canada: 22 6 7

France : 41 6 8 Germany : 45 7 10 UK : 22 5 7

Italy : 29 3.5 4.5 Spain : 23 2 3

Brazil : 30 15 28 Mexico : 10 4 8

China : 67 31 58 India : 14 13 27

Japan : 111 6 10

Australia : 13 1.5 2.5 `

Pharma market (US$ bn / 2011) Gx market (US$ bn / 2011) Gx market (US$ bn / 2016)

Strong Market Presence in Significant Geographies 1

Page 7: Lupin Ndg Mosl 25 Aug 14

Pharmerging Markets: Significant Growth Potential

CAGR (F) % 2012–2017

2%

2%

7%

13%

Source: IMS Health Global Market Prognosis, May 2013, at ex-manufacturer price levels, constant local currency (LC)$. Contains Audited + Unaudited data. Source: IMS.

Global Pharma Sales Global Market Size 2012: US$ 900 bn 2017E: US$ 1,200 bn CAGR: 4.4% p.a.

0

200

400

600

800

1,000

1,200

2008 2012 2017 (F)

Top 8 Mature Markets Other Developed Markets

Other Emerging Markets Pharmerging Markets

US

$ bn

Strong Market Presence in Significant Geographies (cont’d) 1

0

100

200

300

400

2008 2012 2017 (F)

Tier 1 (China) Tier 2 (BR, RU, IN)

Tier 3 Higher Drug Sales per Capita Tier 3 Lower Drug Sales per Capita

Page 8: Lupin Ndg Mosl 25 Aug 14

Excellent R&D and Regulatory Capabilities R&D Focus Areas

Regulatory Understanding

R&D and Regulatory Capabilities

Clinical Capabilities

API Capabilities

Formulation Capabilities

2

ANDAs

Para IV Filings

Complex Generics

Specialty and Biosimilars

NCEs

Complex Injectable, Derm, Controlled Substance Inhalation,

Inhalation, Derm, Biosimilars

Do it sustainably R&D capabilities driving broad product portfolio

Ability to Manage Scale

Ability to go up on Complexity

Page 9: Lupin Ndg Mosl 25 Aug 14

World Class Manufacturing 3

Vertically Integrated and diversified manufacturing platform 1

Ability to manufacture key products from two or more sites 3

Extensive capabilities in multiple dosage forms – solids, semi-solids, liquids, injectables and more 4

Consistent Compliance track record 5

Control over entire supply chain right from early intermediates 2

Page 10: Lupin Ndg Mosl 25 Aug 14

Stellar Execution Track Record 4

Consistent revenue growth across key markets

Consistent track record of product filings and launches

Enhanced manufacturing and supply chain capabilities

Quality culture across the organization

• Consistent Revenue and profitability growth • Business needs to deliver from all key markets and products

• Steady flow of filings and approvals

• Vertically integrated manufacturing capabilities across dosage forms

• Responsive and agile supply chain

• No critical observations and no or few 483s in all audits • 24x7 compliance and audit readiness

Differentiated market entry approach

• Substitution markets – US, UK, Australia, etc. • Branded Generic markets – Japan, Eastern Europe, etc. • Emerging Markets

Page 11: Lupin Ndg Mosl 25 Aug 14

Growth of Indian Pharma Players

Source: Citi Research.

Phase Building Base Expansion Widening Horizon Consolidation Acceleration Business Dynamics

•  API players in India and emerging markets

•  Growing branded formulations business in India

•  Rising formulation presence in India and Emerging Markets

•  DMF filings – API supplies to US begin

•  US and EU Generics opportunity - Para II/III ANDAs

•  In the late 90s, some companies start taking the P-IV route

•  Ramp up in US DMF filings

•  India market growth accelerates

•  ANDA portfolio ramp up, some success with P-IVs

•  More Indian cos enter the US

•  Acquisitions to boost presence/portfolio

•  Robust India market growth

•  US scale up, success in P-IV/complex products

•  Pipelines—quality and quantity

•  Focus on other Emerging markets

Macro Backdrop

▲ New patent regime in India – product patents not recognized

▲ Good process chemistry skills

▲ Hatch Waxman Act

▼ Rising competition in the home market

▲ Formulation facility approvals

▼ Slow growth in India

▲ Rising India GDP drives penetration

▼ Rising competition and pricing strain in US

▲ Big patent expiry wave in the US

▼ Regulatory pressure on pricing, especially in Europe

Timeline 1970–1980 1980–1990 1990–2000 2000–2008 2008–2013

Key Enablers Reverse Engineering

Reverse Engineering,

Low Cost Structure

Vertical Integration, Regulatory Expertise

Formulation capabilities, Regulatory Expertise

R&D Skills, Brand Building,

Marketing Muscle

Page 12: Lupin Ndg Mosl 25 Aug 14

Indian Generics – US market share by value

Indian companies have doubled their dollar market share in the US in the past 5 years

27 29 32 34

38 40 43

4.5% 4.7% 5.6% 5.2%

6.8%

8.4% 9.5%

0%

2%

4%

6%

8%

10%

0

10

20

30

40

50

60

2006 2007 2008 2009 2010 2011 2012

($bn

)

US Generics Market Market Share (by Value) %

Source: MOSL

Page 13: Lupin Ndg Mosl 25 Aug 14

Indian Generics – US market share by volume

Indian companies volume share has increased to ~25% from ~12% five years ago

Source: HSBC

Page 14: Lupin Ndg Mosl 25 Aug 14

Pipeline Evolves to More Complexity

Oral Solid

Oral Contraceptives

Oral Suspension Complex

Controlled Release

Complex Injectables Inhalation

Derm

Biosimilars

Controlled Substances

Ophthalmic

Complexity

Barriers to Entry

Indian company pipelines, esp. of lead companies is rapidly evolving to more complex products, platforms and dosage forms

Page 15: Lupin Ndg Mosl 25 Aug 14

Biosimilar Opportunity

Opportunity is large. High variability seen in the forecasts due to uncertainties around regulatory pathways and uptake.

Source: IMS

Page 16: Lupin Ndg Mosl 25 Aug 14

Worldwide sales of all products losing U.S. patent protection

Value of patent expiries remains strong, esp. biologics

USD billions, net sales

SOURCE: EvaluatePharma (2012)

Small molecule

Biologics

14 19 19 20 25

30 41

58

21

34 34

18 19 20

7

12

8 15

13 5

29

18

49

17

24

16

31

15

49

14

41

13

33

12

66

11

41 1

10

32 2

09

25

08

21 1

07

21 1

06

19

2005

16 1

Page 17: Lupin Ndg Mosl 25 Aug 14

Strategy for Generics going forward

Market Focus

• US to remain the biggest generic market • Maximize opportunities in markets like Europe and Japan • Focus on emerging markets – India, Russia, LatAm and China

Product Portfolio

• Ensure sustainable, predictable product pipeline • Build and acquire capabilities for complex generics and

specialty areas (e.g. complex injectables and inhalation) • Biosimilars

Driving Operations Excellence

• Focus on margin enhancement and overhead optimization • Best practices in supply chain management • Attract global talent and build leadership pipeline • Regulatory and Quality Compliance

Building Blocks to deliver the next phase of Growth

Page 18: Lupin Ndg Mosl 25 Aug 14

Section 2 Building a Specialty Business

Lupin Ltd.

Page 19: Lupin Ndg Mosl 25 Aug 14

Why Specialty? Specialty has strong fundamental growth drivers underpinned by significant barriers to entry

Specialty Pharma Set to Grow at the Expense of Big Pharma Specialty Pharma Positioning

• High revenue visibility and sustainable earnings

• Significantly higher margins than Generics

• Barriers to entry

– Focus on differentiated products

– New technology and creation of IP

– Clinical expertise and expense

– Life cycle management

• Lower R&D and sales force costs compared to Innovator / Big Pharma

• Stepping stone to Big Pharma game

Low

High Low

70% 64%

53%

20% 27%

39%

10% 9% 8%

2005 2010 2015E

Patented Generic Others

Page 20: Lupin Ndg Mosl 25 Aug 14

Big  Pharma,  85%

Big  Biotech  &

Specialty,  15%

Big  Pharma,  70%

Big  Biotech  &

Specialty,  30%

Why the shift to Specialty?

Generics Specialty Generics

Key

Driv

ers

Moving to a mix of specialty + generics because of market dynamics

“In 2013, performance of Big biotech and specialty pharma

companies exceeded that of Big pharma, in

terms of topline, valuations and M&A

premiums”

Market Valuations Share Evolution

Volume driven business Price risk à Low margins

High competition à Saturation Low cost manufacturing

challenging Lesser small molecules LOEs

Value driven high margin business High prices

Lower competition Complex manufacturing Life Cycle Management

High promotion expenses

2013 Source: EY

2009

Page 21: Lupin Ndg Mosl 25 Aug 14

Case Studies in Creating Value through Specialty Transformation

•  Grew by $10 bn in Revenues in 2 years

•  Market Cap up by $52bn in 2 years

•  Grew by $3 bn in Revenues in a year

•  Market Cap up by $10 bn in 2 years

Page 22: Lupin Ndg Mosl 25 Aug 14

Watson / Actavis Transformation

2000 2006 2009 2011 2012 2012 Schein ANDRx Arrow Specifar Ascent Actavis

Generics Controlled release tech

Ex-US Euro distribution Asia Pacific 3rd largest generic global

Nephrology Generics distribution

Biologic / biosimilar base

European manufacturing

Regional marketing

10% US share

Rev.: $0.8 B $2.0 B $2.8 B $4.6 B $5.4 B $8.0 B

Evolution to Global Generics Leadership

48%

27%

15%

10%

2014E - Balanced US Brand/Generic/Intl/Distribution

Revenues

N America Rx

N America Gx

International

Anda Distrib

Post Warner Chilcott: 25% Brand; Post Forest: 48% Brand

Evolution to Specialty Business at Scale

Watson/Actavis: scale •  Adds global footprint •  3rd largest global generic company Actavis/Warner Chilcott •  Specialty brand/pipeline •  Irish domicile/tax efficiency Actavis/Forest •  Specialty brand/pipeline

Actavis 4/12 WC 5/13 Forest 2/14

Deal Value ($B) 5 9 25

Pre Mkt Cap 6 17 32

Post Mkt Cap 11 26 57

10x Mkt Cap increase in 2.5 Yrs

Post Forest: $15B

Revenue

Page 23: Lupin Ndg Mosl 25 Aug 14

Mylan: From US Generic to Multinational Specialty/Generic Hybrid

2007 2007 2011 2012 2013 2014 Merck Generics (includes Dey

Labs)

Matrix (72% stake)

Pfizer respiratory Partnership with Pfizer for Japan

Agila Abbott

90 country presence

API vertical Platform for Advair and others

Japan generics injectables ex-US specialty brands and branded generics

Epipen brand Asia presence

Ex-US branded infrastructure (2000 reps)

Improves ex-US tax structure

Revenue: $1.6B $6.1B $6.8B $6.9B Projected ProForma: $10B Rev/$3B EBITDA

•  Evolving specialty/branded generic presence over time •  From 70% external manufacturing to 80% internal

manufacturing •  Globalization of generics and branded footprint •  Significant multi-years investment in high barrier

generics and in capacity to produce (inhalation/biosimilars/complex inj)

•  Balance of organic growth and M&A

North  America  60%  

Europe  24%  

ROW  16%  

Mylan  

North  America  48%  Europe  

33%  

ROW  19%  

Mylan+Abbo+  

Generic  85%  

Specialty  15%  

Mylan  

Generic  67%  

Specialty/  

Branded  Gx  31%  

OTC  2%  

Mylan+Abbo+  

Mkt Cap: $9.6B Mkt Cap: $19.2 B

Page 24: Lupin Ndg Mosl 25 Aug 14

Specialty pharma market has seen significant rise in approvals

No. of 505(b)(2) approvals has been constantly increasing over the last few years

4643

39

33

28

0

10

20

30

40

50

2012 2011 2010 2009 2008

No. of 505(b)(2) approvals

SOURCE: FDA Website

▪  Specialty pharma companies account for >$65B in revenues with a 6-8% annual growth rate and much higher valuation ratios than generic pharma companies

▪  Leading players include Allergan, Endo, Forest, Hospira, Jazz, Teva and Valeant

▪  505(b)(2) pathway is seen as a low-cost way to enter branded markets, adding $15-20B in overall new pharma sales with approvals recently outpacing those of NMEs

Page 25: Lupin Ndg Mosl 25 Aug 14

Specialty product approvals (cont’d)

More specialty drugs than traditional drugs have been approved every year since 2010

Source: FDA and PWC

Specialty drug approvals inch out traditional drugs

22 22 18 23 24 14 18 22

8 9

6 7 8

8 10

12 17

21

19 10

0

15

30

45

60

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Dru

gs a

ppro

ved

(FD

A)

Traditional Specialty

28 29 26

31 34

26

35

43

27

19

Till July

Page 26: Lupin Ndg Mosl 25 Aug 14

Specialty in US – Spending

Source: pwc and Express Scripts

Specialty drugs will account for nearly half of US drug sales in coming years

53%

61%

47%

39%

2020

2013

62%

66%

38%

34%

2020

2013

Global Spending US Spending

Traditional Specialty

Global Spending on specialty drugs is expected to increase by 361% from $87bn in 2012 to $402bn in 2020 as they carry a higher price tag…

Page 27: Lupin Ndg Mosl 25 Aug 14

Specialty – Barriers to Entry

Many challenges for a generic manufacturer to crack the Specialty business

Challenge Description Therapy Area Focus •  Need to identify and work on select niche therapy areas with

a long term perspective in mind •  Large therapy areas are domain of Big Pharma

Product Development

•  Specialized research and clinical/regulatory capabilities needed

•  Need clear medical advantage in products identified •  Clear differentiation advantage to payors also •  Complex and expensive R&D required including clinical trials

High development cost

•  High development cost compared to generics •  Clinicals usually involved •  Spend $3-25 million per product

Life Cycle Management

•  Need to have clear LoE strategy •  Sustainable pipeline

Page 28: Lupin Ndg Mosl 25 Aug 14

Specialty Strategy

Market Focus • Developed markets – US is the biggest market but markets

like Western Europe and Japan are interesting also • Market needs to incentivize innovation

Product Portfolio

• Focus on niche Therapy Areas – Dermatology, Pediatrics, Gastroenterology, etc.

• Proprietary platforms like inhalation device is a plus • Build capability to develop product portfolio, esp. research,

clinical and regulatory capabilities

M&A • The best Specialty companies have been built by a series of

acquisitions • Technology Platforms, Products and Companies

Page 29: Lupin Ndg Mosl 25 Aug 14

Section 3 Lupin

Lupin Ltd.

Page 30: Lupin Ndg Mosl 25 Aug 14

Market Cap

Revenues

PAT

PAT%

FD%

2005

Rs. 22 bn.

Rs. 1,161 cr.

Rs. 84 cr.

7%

45%

2014

Rs. 418 bn.

Rs. 11,087 cr.

Rs. 1,836 cr.

17%

90%

Lupin’s Journey

CAGR 39%

CAGR 28%

CAGR 41%

Page 31: Lupin Ndg Mosl 25 Aug 14

• Lupin is a vertically integrated global generics player with an emerging specialty presence

• Business spread across regulated and emerging markets

• Extensive R&D capabilities across API, formulations, Biosimilars and Drug discovery

• R&D expense at 8.4% of sales for FY14

• 200 ANDAs filed, of which 103 are approved as of June 30, 2014

• Manufacturing facilities

– 12 sites across the globe (10 in India & 2 in Japan)

– 9 Formulations sites and 5 API sites

• Team of over 1,400 scientists and 15,000 employees

Lupin Today

FY14 Revenue Mix

Formulations 90%

API 10%

US 44%

India 22%

Japan 12%

API 10%

ROW 9%

Europe 3%

Total Revenue: US$1,848 mn

By Business Mix

By Market

Page 32: Lupin Ndg Mosl 25 Aug 14

Our Market Position

1. AIOCD AWACS March 14. 2. IMS MAT March 14. 3. Bloomberg as on August 19, 2014. 4. Street research. 5. IMS July 14.

2.8% IPM Market Share

(by total sales1) Market Size: $13 bn4

4th

Largest South Africa Generics

Player2

No. 1 in CVS Market Size: $4 bn4

Emerging Markets

5th Largest US

Generics Player (by prescriptions2 5.3% )

Market Size: $95 bn4

8th Largest Japanese

Generics Player2

Market Size: $10 bn4

Advanced Markets

6th

Largest Generics Player

(by market cap3)

10th

Largest Generics Player

(by sales3)

Globally

3rd

Largest Indian Pharma Player

(by total sales)

No.1 In Anti-TB Globally

11th Largest Player in

Indian Pharma Market (5)

Page 33: Lupin Ndg Mosl 25 Aug 14

Lupin has historically delivered outstanding shareholder returns

Total return to shareholders

CAGR Percent, INR Total return index

Dec 2000 = 100, INR

8Teva

Mylan 12

Cipla 14

DRL 18

Lupin 35

Sun Pharma 36

SOURCE: DataStream

0500

1,0001,5002,0002,5003,0003,5004,0004,5005,0005,5006,000

Jan-

14

Jan-

13

Jan-

12

Jan-

11

Jan-

10

Jan-

09

Jan-

08

Jan-

07

Jan-

06

Jan-

05

Jan-

04

Jan-

03

Jan-

02

Jan-

01

Mar 2012 – Jun 2014

6

42

18

20

36

49

BSE Sensex Lupin India Pharma Dec 2000 - Jun 2014

Market capitalization1

(USD bn)

25.6

8.2

7.5

5.8

19.3

45.9

1 Market capitalization as of Jul 18, 2014

Page 34: Lupin Ndg Mosl 25 Aug 14

Lupin’s Transformation

Anti-infective and API focused domestic player

Pre-2005 Generics and branded generics player focusing on domestic and regulated markets

2005–2013 Global specialty and generics player

2014 …

2002 •  First 5 ANDA’s filed •  Exports cross INR 1bn 2003 •  Lupin Pharmaceuticals Inc

founded in USA

2005 •  Suprax® launched

2006-08 •  Generics business launched •  Acquired Kyowa in Japan •  Indore SEZ and Biotech facility 2009 •  Acquisitions in Australia,

Germany and South Africa 2010-13 •  Sales crossed US$ 1 bn •  Acquired I’rom in Japan •  No.1 amongst US generics

players with 99.6% fill rates •  Foray into OC’s, ophthalmics

and derm

2014 •  Mexico acquisition leads entry

in LatAm Market •  Yoshindo JV for Biosimilars •  Nanomi acquisition marks

entry in complex injectables space

•  2 new research centers in US •  Brand build through Alinia® and

Locoid® cream

Page 35: Lupin Ndg Mosl 25 Aug 14

Business Growth – Last 12 Quarters

15.4 17.4

17.9 18.8 22

.2

22.4 24

.7 25.4

24.2 26.3 29

.8 30.5 32

.8

3.0 4.1

3.8

3.8 4.8 5.2 6.3 6.6 6.9 7.4 8.1 8.8 11

.4

19%

23%21% 20%

22%23%

26% 26%29% 28% 27% 29%

35%

0%

10%

20%

30%

40%

0.0

10.0

20.0

30.0

40.0

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1

Rs  bn.

Revenues EBITDA EBITDA  Margins

2014-15 2011-12 2012-13 2013-14

Revenues doubled growing at a rate of 6% compounded per month, and EBITDA tripled growing at a rate of 12% compounded per month for last 12 quarters

…EBITDA margins at 35% in Q1’15 vs 19% in Q1’12

Note 1 - Compounded monthly growth rates

Page 36: Lupin Ndg Mosl 25 Aug 14

Q&A

Lupin Ltd.