Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in...

38
Lupin Limited February 4, 2004 Lupin Ltd.

Transcript of Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in...

Page 1: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Lupin Limited

February 4, 2004

Lupin Ltd.

Page 2: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Safe Harbor Statement

The information presented in this presentation contains forward looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in the following materials represents management's expectations and intentions asof date. Lupin expressly disavows any obligation to update the information presented in this presentation

Lupin Ltd.

Page 3: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Our Mission

To be an innovation led transnational pharmaceutical company

Lupin Ltd.

Page 4: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

What are we today…..

• Amongst the Top 5 pharmaceutical companies in India• Strong R&D Process Chemistry, ANDA, NDDS,NCE• Focused on US, EU, India, China• In India Lupin has 20 brands in the "Top 3" of respective

segments• US FDA approved manufacturing facilities• Leading player in anti-TB, Cephalosporins

Lupin Ltd.

Page 5: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

World class manufacturing…

• India's only finished products sterile cephalosporins facility to receive approvals by the USFDA and UKMCA

• Asia's only USFDA-approved fermentation plant for rifampicin

• Successful USFDA certification for 9 manufacturing facilities

• WHO certified finished products manufacturing facility for tuberculosis products

Lupin Ltd.

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World class facilities

Tarapur

Ankleshwar

Aurangabad

Mandideep

LCTL(Thailand)

Pune

Goa

Manufacturing

Research CenterLupin Ltd.

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Mandideep, Bhopal, Central India

Hub of Lupin's competencies in cephalosporins and prils- FDA approved Injectable/Oral Cephalosporins facility- FDA approved Cephalosporin API facilities- FDA approved facility for Lisinopril

Lupin Ltd.

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Tarapur, Western India

• Fermentation Facility (FDA Approved)– Rifampicin – Lovastatin

Lupin Ltd.

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R & DCHEMISTRY

ANDANDDS

Core

Strengths

Therapeutics•TB•Cephalosporins•CVs

FacilitiesIntegrated/cost effective manufacturing

Lupin Ltd.

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Research Capability

•• State of the art Research Park at Pune, IndiaState of the art Research Park at Pune, India•• 150,000 sq. ft., 20150,000 sq. ft., 20--acreacre•• Over 180 scientistsOver 180 scientists•• 133 Patents filed till date, 50 granted.133 Patents filed till date, 50 granted.•• 13 DMFs and 5 ANDAs filed with the US FDA13 DMFs and 5 ANDAs filed with the US FDA

Lupin Ltd.

Page 11: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Research focus

ANDANDDS

NCE

IP

ADVANCED MARKETS

CREATING V

ALUE

PARTNERING GLOBALLY

Lupin Ltd.

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Research focus:Intellectual Property Management

• Intensive product identification process• API complexity• Finished product complexity• Commercial potential of products

• Cautious risk management• Dovetailed with research groups

Lupin Ltd.

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Research focus:NDDS – creating value

• Development of value added products• Six patent applications filed for NDDS platforms• Ceff-ER (cephalexin once-a-day) and Odoxil OD (cefadroxil

once-a-day) launched in the domestic market• Projects for treatment of HIV and TB• Out licensing opportunity to global majors

Lupin Ltd.

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Research focus:NCE – creating value

• Team of 60 scientists• Focus on synthesis and herbal based products• Collaborative research with CSIR: anti TB and Psoriasis• Achievements:

• Anti Migraine - IND approved by ICMR / DCGI, clinicalsbeing initiated in India

• Anti Psoriasis (Desoris) – IND filed with DCGI

Lupin Ltd.

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Highlights of the current year

• R&D:– We received IND approval for our Migraine product– Filed IND for our Psoriasis product– Received 3 ANDA approvals, including first approval for

Ceftriaxone• Business:

– Launched our first ANDA Cefuroxime Ax in the US– International revenues contibuted 47% of turnover– Regulated markets contributed 30% of turnover– Domestic market grew at 19%

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API – Global Position

2Cephalosporin -Intermediate

7ACCA

1Cephalosporin -Intermediate

7ADCA

1Anti-TBPyrazinamide

1Anti-TBRifampicin

1Anti-TBEthambutol

RankTherapeutic Segment

Product

Amongst the top 2 in each area of focusLupin Ltd.

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US / EU Market focus

July 2003On approval

July 2005

July 2003Expected

October 2003September 2003

Formulation• Cefuroxime Axetil Tablets• Cefixime Tablets & Dry Suspn• Ceftriaxone Injection• Cefotaxime Injection

LaunchApprovalProduct

• 5 ANDAs filed, 3 approved; including 2 injectables• 13 DMFs filed with the US FDA• 75 dossiers filed in the EU

Lupin Ltd.

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India & new markets

• Grow in India• Expanding therapeutic width• Value added products• In-licensing & co-marketing• Herbal Product portfolio

• Increasing presence in CIS• Enter Japan, ANZ and Latin America

Lupin Ltd.

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Europe

• Key markets – UK, France, Germany, Italy

• Identified product pipeline for each market

• Working through marketing partners

• Long term supply contract with key customers

Lupin Ltd.

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Lupin’s US focus

• API• Continue to growing the business through partnerships

• Generics• Leveraging Lupin’s integrated manufacturing capability to

introduce a portfolio of generic products

• Specialty • Committed to providing quality products for pediatric practice in

the US market

Lupin Ltd.

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Generic Market Focus

• Building the product portfolio- gearing to file 8-10 ANDA’s per year• Oral/Injectable Cephalosporins• Cardiovasculars• Controlled Release ANDA’s• Paragraph IV’s

Lupin Ltd.

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Finished Dosages – US opportunity

Products worth $ 50 bn to go off patent by 2010Products worth $ 50 bn to go off patent by 2010

0

2000

4000

6000

8000

10000

12000

14000

'04 '05 '06 '07 '08 '09 '10

US $ mn

OUR TARGET MARKET $ 20 bn

Lupin Ltd.

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Specialty Focus

Pediatric Market

We see eye to eye with Kids

Lupin Ltd.

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Opportunity…

• Substantial market potential ($8B+)• Niche market with large unmet needs• Very few companies focus on pediatrics• Fastest growing Rx segment• Niche Physician targets-Pediatricians, pediatric

allergists & other HVP• Lupin’s Development strength in convenient

dosage forms & taste masked products.

Lupin Ltd.

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First brand - SUPRAX

• FDA approval expected shortly• Ready to ship product • Launch with 45 reps• Dedicated to calling on pediatricians and FP’s who Rx

antiinfective oral suspensions• Target 10,000 high Rx’ing physicians• Suprax in first position on all detailing calls

Lupin Ltd.

Page 26: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Financial Review

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Revenues: the rising trend

137.6163.5

200.7

46.5

56.3

0.0

50.0

100.0

150.0

200.0

250.0

300.0

2001-02 2002-03 2003-04 (9m)

USD mn

184.1

219.8

23%19%

Lupin Ltd.

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9 Months Review FY 2003-04Net Sales – Segment Mix

USD mn

45%

55%

% toTotal

164

73

91

2002/03

23%201Total

34%49%98Formulations

13%51%103API

Growth over PY

% toTotal

2003/04Particulars

Page 29: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

37%

48%

5%11%

23%

50%

17%

10%

Anti TB Cepha Cardiac Others

Therapeutic ProfileExpanding chronic segments

FY 2001-02 FY 2003-04 (9m)Lupin Ltd.

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Changing Scenario:Focus on advanced markets

10%

68%

19%2%

30%

53%

15%2%

India US/EU SEA & China Others

FY 2001-02 FY 2003-04 (9m)Lupin Ltd.

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Changing Scenario: Increasing global presence

47%

70% 68%59% 53%

41%32%30%

0%

20%

40%

60%

80%

100%

2000-01 2001-02 2002-03 2003-04(9m)

Exports IndiaLupin Ltd.

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Pre-tax income: rising faster

USD mn

21.2 21.3

35.0

0.0

10.0

20.0

30.0

40.0

50.0

2001-02 2002-03 2003-04(9m)

•2003-04 (9m) Pretax income before extraordinary expenses

Lupin Ltd.

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Key financial indicators

26.016.0Post Tax Income (before extraordinary)

35.017.4%

21.39.7%

Pre Tax Income% to revenues

200.723%

219.819%

Gross Revenuesyoy growth

40.318.4%

2002-03

49.424.6%

2003-04 (9m)

Operating Margin% to revenues

ParticularsUSD mn

Lupin Ltd.

Page 34: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Improving cost trends

56.728.2%

63.829.0%

SG&A Expenses% to revenues

200.723%

219.819%

Gross Revenuesyoy growth

100.845.8%

2002-03

85.442.5%

2003-04 (9m)

Material Cost% to revenues

ParticularsUSD mn

Lupin Ltd.

Page 35: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Key Ratios

0.85:11.70:1Debt Equity

15%

2002-03

26%

2003-04 (9m)

ROCE (before extraordinary)

Particulars

Page 36: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Major investments to support the future, in place

20023.7Anti TB modernization

20032.9IT initiatives

20013.3Oral Ceph. dosage facility

58.0

5.5

4.8

2.2

4.8

30.8

FY2001-04

2004

2004

2004

2003

2001

Comm. Year

xCephalosporin Intermediates

xNon-ceph oral new dosage facility

xAPI Statins facility

New API Prils facility

…..Research and Technology

BenefitsUSD mn

Page 37: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Realizing the dream

Time

Value

Global Generic business

Critical Mass in focus markets

Leveraging India advantage

International generics

SpecialtyPharmaceutical

Innovative research

Horizon 1Drive core growth

Horizon 2Build momentum of

growth engines

Lupin Ltd.

Horizon 3Secure future options

Expanding discovery research

International clinical development

Rx marketingBrand building in developedmarkets

Proprietary technology products

Networking and alliances

Page 38: Lupin Limited at the GS Conference - Feb... · Safe Harbor Statement The information presented in this presentation contains forward looking statements that involve known and unknown

Thank You

Lupin Ltd.