Jefferies Global Health Care Conference
New York June 5, 2013
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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®, Rifamycin SV
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including the potential for delays in the development programs for Budesonide MMX®, Rifamycin SV
MMX®, Methylene Blue MMX® and CB-03-01 . 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.
Cosmo Pharmaceuticals
• Founded 1997; 2007 completed IPO on Swiss Stock Exchange (SIX:COPN), raising € 30 m. Current market cap ~ US$ 850 m
• Focus on gastrointestinal and skin diseases
• 2 products in market for mild to moderate Ulcerative Colitis using
A profitable specialty pharma company
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• 2 products in market for mild to moderate Ulcerative Colitis using proprietary MMX technology:
• Lialda licensed to Shire 2007, 2012 sales $ 400 m
• Uceris licensed to Santarus/Cortiment for US, licensed to Ferring for EU, both approved Jan 2013, launched in US Feb 2013
• 2 additional products in phase III and one in phase II
• Financially robust: historically profitable with increasing royalty and manufacturing revenues, strong cash position
€ million 31.12.2006 31.12.2012
Revenues 15,2 59,5
R&D Cost 3,9 10,9
Total Cost 13,8 33,1
Operating Result 1,4 26,4
Net Income -0,3 19,3
Cash & Financial Assets 2,3 93,4
Steady financial development since IPO
Cash & Financial Assets 2,3 93,4
Inventory & Receivables 4,1 8,4
Total Assets 25,3 151,8
Equity 4,7 124,6
Debt 10,7 12,8
Payables 4,9 4,0
Other liabilities 5,0 10,3
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Cosmo Pharmaceuticals
• Develop a new technology (MMX) to create new drugs using existing chemical and biological entities: > probability of success, < risk
• Improve efficacy
• Improve compliance
How did we get there ?
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• Improve safety
• Establish ways of entrenching the market position
• Increasing range of patents
• Exclusive in-house manufacturing of all MMX products
• Know your strengths
• Focus on areas of expertise: Colon and topical applications
• Restrict yourself to your skills: develop and manufacture
4h 30’ ascending colon 7h 30’ trasverse colon1h 30’ duodenum
MMX® technology at a glance: proof of advantage
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10h trasverse colon
4h 30’ ascending colon 7h 30’ trasverse colon1h 30’ duodenum
16h descending colon 24h rectum
Focus on IBD, a disease with little recent innovation
Immuno-suppressants
Surgery
LMW Heparin MMX®
SEVERE(1)
Uceris™
Prednisolone: late 50’s
Remicade*: 1999Humira*: 2003Tysabri*: 2008
Imurek*: 1981Sandimmun*: 1983Sandimmun Neoral* : 1995
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Diet (+ Probiotics)
Aminosalicylates(5-ASA)
Corticosteroids
Zacol NMX®
Lialda®/Mezavant ®/Mesavancol ®Launch date: 2007
1. Status of disease severity° EU* US
MILD(1)
Rifamycin SV MMX®Asacol*: 1992Pentasa* : 1993Colazal*: 2000
Prednisolone: late 50’sBudenofalk°°°°: 1998Entocort EC *: 2001
Flagyl*: 1963Ciproxin*: late 80’sXifaxan*: 2004
Methylene Blue MMX®
First MMX® product in market: Lialda®
Prior to Lialda®: Total of 16-24 5-ASA tablets of 250 mg taken three
times a day
now:
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now: 3-4 tablets of 1200 mg taken at once
In € m Shire revenue in m $
Royalties for Cosmo
Manufacturing income for Cosmo
Total Cosmoincome
2007 50 1,2 2,7 3,9
2012 399 11,6 14,5 26,1
Parameters of Lialda®
24% share of the 5-ASA market and growing
Cosmo is sole manufacturer at indexed prices
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Cosmo is sole manufacturer at indexed prices
Requirements for attainment of bioequivalence are very challenging
ASA Market: mid size market, continuous growth
2% 2%2012 Nov YTD IMS Sales
$ 1.7 billion; 7% growth p.a.
~ 700’000 patients in USA; ~70% mild to
moderate
30%
12%
24%
16%
4%
2% 2%
10% Asacol
Asacol HD
Lialda
Pentasa
Apriso
Sulfa
Generic Mesalamine
All Other
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Second MMX® product in market: Uceris™*
• Steroids are more effective than 5-ASAs but they generally have a vastly inferior safety profile
• No steroid was approved for use in mild to moderate ulcerative colitis
Locally acting steroid with MMX® colonic delivery
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colitis
• Uceris™ is corticosteroid with local effect, avoiding significant side effects of systemic corticosteroids
• FDA approved on January 14, 2013 for induction of remission in patients with active, mild to moderate ulcerative colitis
• Only steroid approved for mild to moderate ulcerative colitis
• Commercial launch commenced mid-February, 2013
*Please see www.uceris.com for full prescribing and safety information;
Budesonide MMX formulation: Uceris in US, Cortiment in EU
Unique position of Uceris™
Systemic
Anti-TNFα
Disease severityat presentation
Anti-TNFα
Cyclosporine Thiopurine
Severe
Step-up according to severity at presentation or failure at prior step
5-ASA
SystemicCorticosteroids
5-ASA / Thiopurine
5-ASA
InductionMaintenance
Moderate
Mild
Kornbluth and Sacher, Am J Gastroenterol 2010; 105: 501-523
Uceris
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Marketing advantages for Uceris™
Budesonide is well known
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MMX ® technology is known through
Lialda®
Uceris™ story is logical
• MMX; Lialda® has a satisfaction rating from gastroenterologists ~ 20% higher than 5 ASAs ; strong indication that this will be even higher for Uceris™
• Time to symptoms resolution is much faster than with 5-ASA’s
• This is likely to increase proportion of newly diagnosed patients that get prescribed Uceris™
USPs of Uceris™ and expectations
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get prescribed Uceris™
• In 6 weeks to March 31: $ 6.6 m net sales on 2018 prescriptions; in April continued rapid increase. Analysts project peak sales > $ 300 m
• Economics: 22% up to sales of $ 120 m, 24% above that, $ 5m at net sales of $ 75m and $ 17.5m at net sales of $ 150m
Competitive TRx Launch Comparison
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Budesonide MMX® outside US
Cortiment® obtained Marketing Authorization in The Netherlands
in January 2013 and market introduction planned for Q3 13
In alliance with FERRING:
●MRP planned to obtain the MA in the other EU countries by 1H 14
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●MRP planned to obtain the MA in the other EU countries by 1H 14
● Intention to submit a MA in Canada, Mexico and South America, Middle East and Far East within the year end.
Unlicensed in Japan
Product
MMX®
MESALAZINE MMX®
BUDESONIDE MMX®
RIFAMYCIN SV
ItalyEastern Europe
EP 1198226 / US 6,773,720
EP 1183014 / US 7,431,943
EP 1287822
US 7,431,943
US 8,293,273
RE 43,799 E
EP 176339 / US 8,263,120
20202018 2022 2024 2026 2028 2030 2032
RIFAMYCIN SV MMX®
METHYLENE BLUE MMX®
LMWH MMX®
ZACOL- ZACOFALK
CB-03-01
EP 176339 / US 8,263,120
EP 1455761
EP 1992338
EP 1421099 / US 8143240
granted
pending17
Rifamycin SV MMX®:
• Pivotal Trials US:• Phase III clinical end point (superiority to placebo in travellers diarrhoea)
in US trial attained
• Designated as New Chemical Entity by FDA in USA
• Pivotal Trial EU:• Patient recruiting for phase III infectious colitis trials in EU ongoing
• Phase III delayed because of change in regulatory process in India. EUtrial is for non inferiority to Cipro. Delay could go into H1 2014.
• Costs Borne by licensees
• Cosmo may share some regulatory costs for relocating trial to Latin
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• Cosmo may share some regulatory costs for relocating trial to LatinAmerica
• Opportunities
• Hepatic Encephalopathy
• Diverticulitis
• More than 60% of people over the age of 60 have diverticulae
– In 10-20% of cases the diverticula get infected and inflamed
• No drug is currently approved for this disease
• Falk is starting phase II trial for non complicated diverticulitis shortly
• Unlicensed in Asia, Africa, Latin America
Colon Cancer Economics
• 7 MMs have 760 m population; ~ 35% over fifty years old
• > 500’000 new colon cancer diagnoses every year in 7 MMs
• 60% of colon cancers are detected in a late stage
• > 170’000 deaths of colon cancer each year in 7 MMs
• Average cost to treat a colon cancer medicare patient: $ 140’000
• Average cost to treat a late stage patient: $ 310’000• Average cost to treat a late stage patient: $ 310’000
• Cost of a colonoscopy: ~$ 1200
• Average time of a colonoscopy: 10-12 minutes
• Average white light polyp detection rate: 44-49%
• Average white light adenoma detection rate: 27-32%
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Identifying dysplasia via Chromoendoscopy
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Making pit patterns visible
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US Colonoscopy market dynamics
• 14 m colonoscopies
• Approx 7 m in large hospitals
• Around 10 % of colonoscopies in large hospital systems are chromoendoscopies
• Cost of a single use spray catheter: $ 80
• chromoendoscopy takes twice as long
• 1 m emergency colonoscopies• 1 m emergency colonoscopies
• 6 m colonoscopies in private practices
• Practically no chromoendoscopies in private practices
• According to a survey by Braintree, the leading colon prep company in the USA, all private practice gastroenterologists would use a dyeing agent if it is not as complicated and messy as chromoendoscopy
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Methylene Blue MMX®; a logical move into diagnostics
Chromoendoscopy is effective but infrequently performed because it is time consuming, messy
and thus too costly
Tabletise methylene blue
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MMX ensures it is not absorbed in stomach and ileum and brings vital dye methylene blue to colon
in random staining process
Tabletise methylene blue
Patients take tablets prior to colonoscopy
Methylene Blue application with MMX tablets
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Methylene Blue MMX penetrates cells
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• Number and proportion of subjects with detected polyps, adenomas and serrated lesions by colonic region in the FAS population (N=96
Study CB-17-01/05: DETECTION RATES
Population Colonic region
Methylene blue MMX® tablets
Subjects with at least
one polyp
n (%)
Subjects with at least one
adenoma
n (%)
Subjects with at least one
serrated lesion
n (%)
All regions 61 (63.5) 45 (46.9) 26 (27.1)
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FAS
(N=96)
Right colon 32 (33.3) 24 (25.0) 9 (9.4)
Caecum 14 (14.6) 13 (13.5) 2 (2.1)
Ascending colon 16 (16.7) 10 (10.4) 5 (5.2)
Hepatic flexure 9 (9.4) 7 (7.3) 2 (2.1)
Transverse colon 12 (12.5) 8 (8.3) 4 (4.2)
Splenic flexure 6 (6.3) 5 (5.2) 0 (0.0)
Descending colon 7 (7.3) 4 (4.2) 3 (3.1)
Sigmoid 21 (21.9) 12 (12.5) 8 (8.3)
Rectum 19 (19.8) 9 (9.4) 12 (12.5)
Adenoma detection rates: comparison with published data
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25
30
35
40
45
50
27
0
5
10
15
20
MB-MMX NBI meta-
analysis GIE
2012
i-SCAN GIE
2012
Split-dose GIE
2012
Screening Berlin
Gut 2012
Methylene Blue MMX® market potential
MB price in USD MB price in USD MB price in USD MB price in USD MB price in USD
80/55 90/65 100/75 110/85 120/95
market share of
% of
colonoscopies
for surveillance
done with dyes
% of
colonoscopies
for IBD done
with dyes after
revenues in $ m revenues in $ m revenues in $ m revenues in $ m revenues in $ m
projected colonoscopies in USA
Canada and Mexico in million
2013 2014 2015 2016 2017
15,89 16,20 16,52 16,84 17,17
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market share of
first entrant
done with dyes
after 5 years
with dyes after
5 years
100% 50% 70% 704,3 796,6 888,8 981,1 1073,3
90% 50% 70% 633,9 716,9 799,9 883,0 966,0
80% 50% 70% 563,4 637,3 711,1 784,9 858,7
70% 50% 70% 493,0 557,6 622,2 686,8 751,3
60% 50% 70% 422,6 477,9 533,3 588,6 644,0
50% 50% 70% 352,2 398,3 444,4 490,5 536,7
40% 50% 70% 281,7 318,6 355,5 392,4 429,3
30% 50% 70% 211,3 239,0 266,6 294,3 322,0
Methylene Blue MMX®: next steps and timeline
EMA approved design. SPA filed with FDA; feed back expected in June
Phase III in 12 well known large hospitals with endoscopy specialization in USA and Europe
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endoscopy specialization in USA and Europe
Phase III completion expected latest Q1 2014
Unique treatment proposition and mechanism of action of CB-03-01
HypothalamusHypothalamus
PituitaryPituitary
TesticleTesticle AdrenalsAdrenals
testosterone
LHRH LHRH Analogues, Inhibitors
LHFSH Cyproterone ac.
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testosterone
DHT
5a reductase Finasteride, Dutasteride, Progesterone
CB-03-01, Cyproterone ac., Flutamide
Receptor
Skin and skin appendages
CB-03-01 in 2012 and onwards
• IND filed and approved
• Signed licensing agreement with Medicis in April 2012
• $ 25 m received
• 360 patients to be enrolled, 4 cohort phase II increasing dose study in acne
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study in acne
• Second cohort under completion, third cohort recruiting, no major adverse events to date
• Valeant acquired Medicis and reaffirmed major strategic interest
• Next milestone
• At end of phase ll $ 20 m (expected H1 2014) depending on successful outcome
Future developments
Use cash to purchase promising projects in non systemic treatment of gastro and
skin diseases
Continue controlling all manufacturing of
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Develop a protein, peptide and MAB MMX®
application for gastro diseases
Continue controlling all manufacturing of MMX applications
• Took Santarus shares in lieu of cash in 2008
• Per 31.12.2012 Cosmo Technologies owned 7’878’544 respectively 12.2% of SNTS shares which were purchased at a price of € 1.77 per share ie € 13.9 m
• Per 15.5.13 4’887’500 SNTS shares were sold for $ 18.25 in
The Santarus investment
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• Per 15.5.13 4’887’500 SNTS shares were sold for $ 18.25 in an accelerated book building in the US
• Present holding is 2’991’044 shares amounting to 4.63% of outstanding shares
• FDA reply to SPA for phase III Methylene Blue MMX in June
• Uceris H1 sales in July
• First patient phase III Methylene Blue MMX
Newsflow 2013
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• Rifamycin End of Phase III EU trial for non inferiority vs Cipro
Cosmo Pharmaceuticals
Information Contacts
• Number of shares: 14,995,743
• Listing: SIX Swiss exchange, Main board
• ISIN: IT0004167463
• Mauro Ajani, [email protected]
• Chris Tanner, [email protected]: +39-02-9333’7453
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ph: +39-02-9333’7453
• Giuseppe Cipriano, [email protected]
• Luigi Moro, [email protected]