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Jefferies Global Healthcare Conference New York June 6, 2012 1

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Page 1: Jefferies Global Healthcare Conference - Cosmo …/media/Files/C/Cosmo...Jefferies Global Healthcare Conference New York June 6, 2012 1 2 Safe Harbour Statement This presentation may

Jefferies Global Healthcare Conference

New York

June 6, 2012

1

Page 2: Jefferies Global Healthcare Conference - Cosmo …/media/Files/C/Cosmo...Jefferies Global Healthcare Conference New York June 6, 2012 1 2 Safe Harbour Statement This presentation may

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Safe Harbour Statement

This presentation may include forward-looking statements that are based on our management’s beliefs

and assumptions and on information currently available to our management.

The inclusion of forward-looking statements should not be regarded as a representation by Cosmo that

any of its plans will be achieved. Actual results may differ materially from those set forth in this

presentation due to the risks and uncertainties inherent in Cosmo’s ability to develop and expand its

business, successfully complete development of its current product candidates and current and future

collaborations for the development and commercialisation of its product candidates and reduce costs

(including staff costs), the market for drugs to treat IBD diseases, Cosmo’s anticipated future revenues,

capital expenditures and financial resources and other similar statements, may be "forward-looking" and

as such involve risks and uncertainties and risks related to the collaboration between Partners and Cosmo,

including the potential for delays in the development programs for Budesonide MMX® and Rifamycin SV

MMX®. No assurance can be given that the results anticipated in such forward looking statements will

occur. Actual events or results may differ materially from Cosmo’s expectations due to factors which

include, but are not limited to, increased competition, Cosmo’s ability to finance expansion plans, the

results of Cosmo’s research and development activities, the success of Cosmo’s products, regulatory,

legislative and judicial developments or changes in market and/or overall economic conditions. Cosmo

assumes no responsibility to update forward-looking statements or to adapt them to future events or

developments.

You are cautioned not to place reliance on these forward-looking statements, which speak only as of the

date hereof, and Cosmo undertakes no obligation to revise or update this presentation.

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Cosmo – an entrepreneur led pharma company

• Identified a market need

• Reduce tablet load from 24 tablets taken at various intervals

• Developed MMX technology based on in-house knowledge

• 3-4 tablets taken all at once

• Objective to find best development & distribution partners but keep all

manufacturing in house since this is our USP

• Built a new manufacturing plant

• Focused MMX applications on niche IBD market

• This created substantial colon knowledge

• Colon expertise allowed identification of large markets

• Careful development of sole new molecule

• Objective: Build a loyal employee base with strong analytical, galenic

and manufacturing skills

• Objective: Only venture into projects that we can finance ourselves

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MMX: Proving extended release

10h transverse colon

4h 30’ ascending colon 7h 30’ transverse colon 1h 30’ duodenum

16h descending colon 24h rectum

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EUR million 2007 2008 2009 2010 2011

Market revenues in $ m 50 140 236 293 372

Growth 180% 69% 24% 27%

Royalties for Cosmo 1,2 3,5 6,0 8,5 10,0

Manufacturing Income for Cosmo

2,7 7,1 6,8 7,7 10,8

Total Lialda Income Cosmo

3,9 10,6 12,8 16,2 20,8

Growth 172% 21% 27% 28%

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Development of first product: Lialda

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Expand the focus of MMX applications to all levels of IBD

Diet (+ Probiotics)

Aminosalicylates (5-ASA)

Corticosteroids

Immuno- suppressants

Surgery

Zacol NMX®

LMW Heparin MMX®

Lialda®/Mezavant ®/Mesavancol ® Launch date: 2007

1. Status of disease severity ° EU * US

MILD(1)

SEVERE(1)

Rifamycin SV MMX®

Budesonide MMX® Uceris®; Cortiment®

Asacol*: 1992 Pentasa* : 1993 Colazal*: 2000

Prednisolone: late 50’s Budenofalk°: 1998 Entocort EC *: 2001

Remicade*: 1999 Humira*: 2003 Tysabri*: 2008

Imurek*: 1981 Sandimmun*: 1983

Sandimmun Neoral* : 1995

Flagyl*: 1963 Ciproxin*: late 80’s

Xifaxan*: 2004

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Product Development to date

• Budesonide licensed out worldwide (except Japan) and phase III trials

in USA and EU completed and filed

• Rifamycin SV licensed out in USA and EU and phase III clinical trials in

final stages

• LMW Heparin phase II completed and partner search underway

• Methylene Blue phase II practically completed

• New molecule CB-03-01 licensed out and treatment of first patient in

phase II acne imminent

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Improvement of income parameters moving forward

• Lialda licensed out at royalty of ~3% (with cap at $ 95 m) plus

manufacturing income of ~ 3%

• Budesonide aspires to be sole approved steroid for treatment of UC in

USA. Total return ~ 4 X higher for Cosmo. No further development

costs for Cosmo

• Rifamycin SV is a NCE in USA, targeted at multiple indications such as

Diverticulitis, a very large market for which no drug is currently

approved. Total return similar to Budesonide

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CB-03-01, a unique NCE in the very large acne and alopecia market

Hypothalamus

Pituitary

Testicle Adrenals

testosterone

LHRH LHRH Analogues, Inhibitors

LH FSH Cyproterone ac.

DHT

5a reductase Finasteride, Dutasteride, Progesterone

CB-03-01, Cyproterone ac., Flutamide

Receptor

Skin and skin appendages

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CB-03-01: way forward

• IND for acne filed, approved and clinical trial underway

• Control of development through end of phase II. Execution through Intrepid Therapeutics

• Total budgeted cost 2012: $ 4.8 m, 2013: $ 3.9 m, 2014: $ 0.5m

• Worldwide license agreement signed with leading US specialty pharma company

• Up front payment of $ 25 m, development, regulatory and commercial milestones, tiered royalties

• All costs after phase II acne and POC alopecia for the account of licensee

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EUR million 31.12.2006 31.12.2011 31.12.2012 e

Revenues 15,2 33,5 59,6

Share of Lialda 15,4% 62,1% 44,1%

R&D 3,9 5,2 12,4

Total Cost 13,8 24,6 32,9

Operating Result 1,4 8,9 26,7

Net Income -0,3 7,6 19,3

Cash & Financial Assets 2,3 31,9 65,2

Inventory & Receivables 4,1 8,4 8,7

Total Assets 25,3 78,0 110,3

Equity 4,7 63,1 95,5

Debt 10,7 2,1 1,3

Payables 4,9 4,1 4,2

Other liabilities 5,0 8,7 9,3

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Cosmo after CB-03-01 milestone and before Budesonide launch

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Colon expertise leads to identification of Methylene Blue MMX for colon cancer diagnosis

• A very large market unique product opportunity

• Colon cancer is the 4th most prevalent cancer after prostate, breast and lung cancer

• In 7 major markets there will be ~ 470’000 new colon cancer patients in 2012

• Deadliest large cancer because only ~ 10% of all cases are detected in stage I

• Improving prevention has attained highest priority from health agencies in all major markets

• Objective is to find adenomas and polyps, the precursors of colon cancer

• The CIN pathway is preceded by adenomas: responsible for 65-70% of all CRC

• The CIMP pathway is preceded by polyps: responsible for 30-35% of CRC

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The benefits of improved colonoscopy

• Colonoscopy is the best diagnostic according to American Society of Gastroenterologists

• With proper pre screening 75%-90% of all colon cancer could be avoided

• Detecting small polyps and adenomas depends enormously on experience and skill of gastroenterologist

• Up to 1/3 of all polyps < 10 mm are not detected

• 6 fold range of adenoma detection rate amongst colonoscopists

• National Health Agencies recommend the use of visual enhancers

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The requirements to overcome the problem

• Provide an easy administration of the product for the patient

• Stain all areas where adenomas and polyps could be

• Stain reliably and homogenously

• Increase time efficiency of colonoscopist

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Methylene Blue MMX

The transformational business case for Cosmo

Indication Colon cancer and IBD dysplasia diagnostic

Market size Recommendations that all persons over 50 have a colonoscopy every 5 years • This would mean 55 m colonoscopies in 7 major markets • 30 m colonoscopies are projected in 2012 • In 7 major markets ~ 270 m persons > 50 years of age

Competition Local non approved liquid applications sprayed via endoscope

Business Rationale

• Requires identical skills to those developing Lialda® • Develop through phase III in USA and EU • Possibly license earlier in Japan

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Dissolution of MB tablets (pH 7.2; 8 hours)

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8

% d

isso

lved

Time (hours)

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Main objectives of studies CB 17-01/03 & 04

• Determine how the tablets should be administered

• Determine optimal dose

• Observe how the mucosa is stained with MMX®-MB

• Make full safety assessment

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CB-17-01/03 – Preliminary conclusions

• Identified the best dose

• Determined that applied staining score is useful:

• Staining score significantly correlates with polyps/adenoma detection rate

• No minor or major AEs recorded in 109 patients

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• End points

• Primary end-point

• Evaluate and describe the polyp detection rate

• Evaluate and describe the adenoma detection rate

• After colonic mucosal staining obtained with single dose of 200 mg of Methylene Blue MMX tablets

• Secondary end-point

• to classify (through better understanding of pit patterns) polyps and adenomas

• to evaluate the serrated lesion detection rate

• Total number of patients included in the trial:

• 100 (trial completed

• Preliminary data available

Study CB-17-01/05 – Polyp and adenoma detection

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• Substantially higher rate of polyp detection seen than with white light

• Adenoma detection rate much higher than previously reported in most updated literature data

• Standard is currently 25% in men >50 and 15% in women >50

• True prevalence could be twice that number

• No minor or major adverse event recorded

• Colonoscopy time comparable to standard white light colonoscopy (no time increase)

• Upcoming statistical analysis with more detailed data on study outcomes

Study CB-17-01/05: Preliminary data

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Study CB-17-01/05: Preliminary data % of detection vs. disease location

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Study CB-17-01/05: Preliminary data % of detection vs. disease location

SIZE MM % POLYP DETECTION

% ADENOMA DETECTION

1-5 (diminutive) > 50% >40%

6-10 (small) < 25% >10%

≥10 ~25% >30%

Page 25: Jefferies Global Healthcare Conference - Cosmo …/media/Files/C/Cosmo...Jefferies Global Healthcare Conference New York June 6, 2012 1 2 Safe Harbour Statement This presentation may

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News events until end of 2012

FDA regulatory decision on

Uceris ®

Decision on destruction of

treasury shares

EU

regulatory

decision on

Cortiment ®

Methylene

Blue MMX

pre IND

meeting

with FDA

Start phase III

of CB-17-01 in

USA and EU Licensing LMW

Heparin

Licensing CB-17-01 in Japan

Q4 Q3 Q2

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Cosmo Pharmaceuticals

Information Contacts

• Half-Year Report 2012: 30 July 2012

• Number of shares: 14,995,743

• Listing: SIX Swiss exchange, Main board

• ISIN: IT0004167463

• Market Cap: CHF 364.40M

• Mauro Ajani, CEO [email protected]

• Chris Tanner, CFO [email protected] ph: +39-02-9333’7453

• Giuseppe Cipriano, COO [email protected]

• Luigi Moro, CSO [email protected]