Jefferies Global Healthcare Conference
New York
June 6, 2012
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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
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
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%
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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]