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Bellevue Health Care Day
Zurich
August 23, 2016
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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 Methylene Blue MMX®, Rifamycin SV
MMX®, and Eleview™. 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 undue 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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2016 First Half Highlights
• Successful completion of EU Phase III trial for Rifamycin
• Decision to set-up own commercial infrastructure in the US; agreementswith US management team close to finalization
• SIC 8000 (re-named EleviewTM) EU approval in June
• MB phase III trial close to completion
• Significant expansion of Cortiment® franchise
• Purchase of 9% of PAION AG and license agreement for Remimazolam, afast acting procedural sedative
• Took an equity stake of 3.98% in VolitionRX
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Financial Condition per 30.6.2016 and outlook
• 14’103’536 shares outstanding
• 638’000 stock options outstanding
• 315’447 treasury shares
• € 414,4 million equity
• € 396,9 million tangible net worth
• € 157,9 million worth of industrial investments
• -€ 3.8 million net working investment
• € 7,7 million debt
• € 14,0 million cash from operating activities in H1
• € 19.7 million payment of dividend
• US$ 6,5 million build up of US organization
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Product Update
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Lialda® & Mezavant® & Mesavancol ®
• Lialda® & Mesavancol® Net Sales
• H1 2016: $ 361.7 m (+18%)
• Cosmo Income
• H1 2016: € 11.0 m (+7.6%)
(€ 0.3 m royalties, € 10.7 m manufacturing)
• 157.3 million tablets delivered (+8.3%)
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Uceris®
• Uceris® estimated net sales in H1
• $ 70.6m versus $ 24.9m in prior year
• Cosmo Revenue on Uceris® (based on estimated Uceris® net sales):
Total Uceris® revenue € 13.8m versus € 4.2m in prior year
• Manufacturing revenue: € 6.2m versus €1.9m prior year
• Royalties: € 7.6m versus €2.3m in prior year
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Cortiment®
• Cortiment® estimated net sales in H1
• € 4.2m versus € 1.6m
• Cosmo Revenue on Cortiment® :
• Manufacturing revenue: € 374k (€ 47k prior year)
• Royalties: € 808k (€ 114k prior year)
• Approved in 41 countries
• Launched in 19 countries
• Registrations pending in 12 countries
• Further 32 countries will be included into the global marketing plan
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Late stage Products
under development
Rifamycin SV MMXgeneral background
• The market is desperately seeking for new antibiotics
• Rifamycin SV MMX (Rifamycin) is a new broad-spectrum antibiotic, withnegligible systemic absorption and lower probability of resistance thanother comparable antibiotics, delivered topically in all colonic districtsthroughout the MMX® technology
• Rifamycin has excellent anti-inflammatory/immunomodulatory properties,ideally suited for the treatment of colonic infections
• Rifamycin is a New Chemical Entity (NCE) in the US
• Rifamycin will, upon approval, enjoy 10 years of exclusivity in the USA under the NCE/GAIN Act combined rules
Rifamycina little science
• Rifamycin has bactericidal activity interfering with the synthesis of nucleic acids by inhibiting DNA-dependent RNA polymerase
• Rifamycin has a broad spectrum of activity targeted to the main enteropathogen microorganisms:
• E. coli (ETEC, EPEC, EHEC, EIEC)
• Salmonella
• Shighella
• Enterobacter faecalis
• Staphilococcus aureus
• Mycobacterium Tuberculosis
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RifamycinTrial design
Two phase III trials jointly requested for US and EU registration:
• Phase III US trial Superiority vs. Placebo (completed bySantarus in 2012)
Randomized, double-blind, multi-centre, placebo-controlled studyto evaluate the efficacy and safety of Rifamycin SV MMX for thetreatment of travellers’ diarrhoea
• Phase III EU trial Non-inferiority vs. Cipro
(by Dr. Falk Pharma)
Randomized, double-blind, double-dummy, multi-centre,comparative parallel-group study to evaluate the efficacy andsafety of oral daily Rifamycin SV MMX 400 mg b.i.d. vs.Ciprofloxacin 500 mg b.i.d. in the treatment of acute infectiousdiarrhoea in travellers
Both trials had positive outcomes with endpoints successfullyreached
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RifamycinTrial Results Outline
• All clinical endpoints successfully reached
• Overall number of patients treated: over 1200
• No Safety issues
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Rifamycinindications sought
US (rights owned by Cosmo)
Travellers’ Diarrhoea
To be extended to: IBS D
Development Timeline: Phase II DR to start in Q3 16
EU (licensed to Dr. Falk)
Infectious Diarrhoea/Colitis
To be extended to: Uncomplicated Diverticulitis
Development Timeline: Phase II P.O.C. ongoing
interim analysis in H2 2016
RifamycinUS case
• Rifamycin is a sister molecule of Rifaximin, the API of Xifaxan®
• Xifaxan® first indication was Travellers’ Diarrhea – launched in 2004 - achieved yearly peak sales under first indication of USD 117m (2009)
• Xifaxan® second indication was Hepatic Encephalopathy - launched in 2010, achieved yearly peak sales under both indications of USD 650m (2014)
• Xifaxan® third indication is IBS-D - launched in 2015
• Xifaxan® expected 2016 sales in excess of USD 1,1 b
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Rifamycinwrap-up
• A new antibiotic ideally suited for colonic infections with no resistance issues
• A NCE in the US with 10 yrs exclusivity
• A product with an easily traceable peer (Xifaxan®)
• A wider indication at onset for the EU (Infectious Colitis)
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The colon cancer prevention strategy
Colonoscopy cancer parameters in USA
• Approximately 15 million colonoscopies for colon cancer prevention are done yearly in the USA
• Total costs for colonoscopies are ~US$ 45 billion per annum
• A colonoscopy costs between US$ 1’000 and US$ 8’500 with the average at ~US$ 3’000
• One in three eligible persons are not screened
• 134’787 persons were diagnosed with colon cancer in the USA in 2012
• Total direct colon cancer costs are ~US$ 14 billion per annum
• 38% of the persons diagnosed with colon cancer die of the disease
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Colonoscopy trends
• With one in three eligible persons not being screened, insurance companies/health care plans may start
• Charging different insurance rates for screeners vs non screeners
• Increasing co-pay rates or refuse coverage for persons > 50 years old that elected not to have a colonoscopy
• Colonoscopy quality needs to be improved
• Increase polyp detection rate
• Increase ease and safety of polyp extraction
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Historical value chain in colonoscopy
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Identification of high colon
cancer risk segment
Non invasive tests
Family history
Fecal occult blood tests
Bowel cleaning
sedation
visualization
Extraction
Propofol; Midazolam
Optical equipment
Nooses, tweezers
Tablets; liquids
Opportunities to segments of value chain in colonoscopy
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Identification of high colon
cancer risk segment
Non invasive tests
Molecular diagnostics
non fecal blood
Bowel cleaning
sedation
visualization
Extraction
reduce time of sedation by faster
onset and quicker wake up
Improve detection rate
faster & safer extraction
Less voluminous dosage
Sedation agent Remimazolam
• Procedural sedation is used in practically all colonoscopies in the USA
• Market is split ~50%: 50% between propofol and midazolam
• Targeted to save costs
• Phase II b clinical trial demonstrate 6 min reduction in sedation time (faster onset and faster wake up) than midazolam allowing time for 1-2 additional colonoscopies per day
• Propofol use will require presence/availability of an anaesthesist
• One phase III completed for colonoscopies and one underway for bronchoscopy
• Licensed in from PAION AG, who will pay for bronchoscopy trial as an ideal marketing complement to EleView and MB MMX
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Methylene Blue (MB):enhancing visual detection
MB: a revolutionary tool for early cancer detection
* According to Phase II Clinical Data, 51% more polyps and
47% more adenomas were found with MB
Normal
Procedure
Time
Whole Colon
stained,
overcoming
operator
subjectivity
Sharp increase in
Detection Rate,
especially for
flat/small lesions*
MB Main TargetPolyps not otherwise
visible
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Methylene Blue MMX
• Development status• Clinical Trial practically completed
• Data cleaning activities ongoing
• Timing• NDA Filing targeted for Q1 2017
• Business Development• Licensing to the RoW is planned to commence in H2 2016
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Extraction of growths
• To avoid risk of perforation, endoscopists need to create a ’’safety cushion‘‘ between the polyps and the deep layers of the GI wall
• Current procedures foresee the injection of normal saline solution; easy to inject but dissipates quickly
• Longer lasting cushions are sometimes obtained with expensive Hyaluronic Acid solutions or self made cocktails
• Strong need to obtain similar long lasting effect with alternative solutions. Ideal product should:
• have low viscosity to facilitate injection
• Provide a long lasting cushion (> 30 min)
• Include a dye to enhance borders definition
• be safe and bio-compatible
• Affordable in terms of pricing
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• EleviewTM is a Submucosal Injectable Composition, easy to be injected, developed to be used in all endoscopic polyp removal procedures in the GI tract
• EleviewTM creates a long lasting cushion which is essential for a successful Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD)
• EleviewTM is dyed with methylene blue, so it helps in visualizing the lesion and performing the resection procedure, minimizing risk of perforation
• EleviewTM is patented, covered by two international and one US patent applications filed in 2014 (priority 2013)
Eleview®
ELEVIEWTM will be used inEndoscopic Mucosal Resection (EMR) …
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• The mucosa is between 1-3 mm thick; key perforation risk
• various techniques have been developed to take out lesions
• EMR for the removal of mucosal lesions that are smaller than 2 cm, or piecemeal removal of larger lesions (> 2 cm)
• A cushion is needed to lift the lesion and facilitate its removal, reducing perforation-risk and damage to the deep layers of the GI wall
Injection in the
submucosaCapture with the snare Removal
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Circumferential injections Mucosal elevationSubmucosal dissection
• Predicted to replace conventional surgery
• Intention to mitigate risks of higher rate of perforation and bleeding complications
• Submucosal injection is essential in ESD, and a high and long lasting submucosal cushion is needed for a safe cutting
• EleviewTM needed if large lesion is to be removed in one piece
… as well as in Endoscopic Submucosal Dissection (ESD)
(used to excise lesions >2 cm)
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Eleview®
• Development status• USA
• approved
• Marketing trials in four sites ongoing (speed and safety versus standard care in EMR)
• EU
• Approved
• Timing• Targeted for launch in EU and USA in H1 2017
• Business Development• Licensing process in EU and RoW ongoing
Cosmo’s Changes in value chain in colonoscopy
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Identification of high colon
cancer risk segment
Non invasive tests Nucleosomic analysis in non
fecal blood by investment
Volition RX
Bowel cleaning
sedation
visualization
Extraction
Remimazolam™ is faster and
safer
MB increases detection rate;
usable with all optical equipment
Eleview™ allows faster & safer
extraction
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Outlook for 2016
• Operations • Set up of US commercial organization has started, two companies incorporated
for the purpose, started hiring personnel
• Slight continued growth in Lialda/Mezavant/ Mesavancol manufacturing revenues
• Normal development in general contract drug manufacturing
• Clinical development • Completion of phase III Methylene Blue MMX in North America and EU
• Completion of Eleview® marketing trials
• Business development• Licensing of Eleview, Methylene Blue ex USA and Rifamycin ex USA & EU likely
to be delayed into 2017
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Cosmo Pharmaceuticals
Information Contacts
• Number of shares: 14,418,983
• Listing: SIX Swiss exchange, Main board
• ISIN: NL0011832936
• Alessandro Della Cha , [email protected]
• Luigi Moro, [email protected]
• Niall Donnelly, [email protected]
• Giuseppe Cipriano, [email protected]
• Chris Tanner, Transactions & [email protected]