Cosmo Pharmaceuticals NV · SIX:COPN
Cosmo Pharmaceuticals NV — JP Morgan Healthcare Conference 2015
34 slides from Cosmo Pharmaceuticals NV's conference presentation, Jan 15, 2015
Slide 1: JP Morgan Healthcare Conference
JP Morgan Healthcare Conference San Francisco January 15, 2015 1
Slide 2: Safe Harbour
Safe Harbour 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 p
Slide 3: Cosmo at a glance: 2013 – E 2014
Cosmo at a glance: 2013 – E 2014 EUR/Million 2013 E 2014 Traditional contract manufacturing and other revenue 10 11 +5.7% MMX® products, manufacturing 20 30 +55,6% MMX® products, royalties 20 23 +12,6% MMX® licence fees, up-front fees and milestones 5 18 +236,0% TOTAL OPERATING REVENUES 56 83 +46,7%
Slide 4: Cosmo: a simple business philosophy
Cosmo: a simple business philosophy … • Leverage on internal know-how • Keep low overheads and small & flexible managerial infrastructure • Develop proprietary R&D • Retain manufacture of own products • Combine optimal returns while minimizing risk in deals structuring 4
Slide 5: … with expertise in deal making
… with expertise in deal making 2001 Licensing deal with Giuliani/Shire 2005 Private placement 2006 Spin off of Cosmo Biotech 2007 IPO on SIX (Zurich, Switzerland) 2007 Licensing deal with Ferring 2008 Licensing deals with Dr. Falk and Santarus 2010 Take over of BioXell 2012 Licensing deal with Medi
Slide 6: A world leader in GI with MMX technology
A world leader in GI with MMX technology MMX allows topical application of API throughout whole colon with no side effects 1h 30’ 4h 30’ ascending 7h 30’ trasverse duodenum colon colon 6 16h descending colon 10h trasverse 24h rectum colon
Slide 7: With two very successful products in the market
with two very successful products in the market Launch 2007 • Lialda First year sales $ 50 m Second year sales $ 140 m 2013 year sales $ 529 m Launch 2013 • Uceris First year sales $ 66 m Second year sales $ 173 m (e) Patent extended from 2020 to 2031 7
Slide 8: Cosmo's distinct path to organic growth
Cosmo‘s distinct path to organic growth 1) Expand GI pipeline 2) Expand activities to other therapeutic areas 3) Willingness for “equity for product” deals 4) Create as much value as possible in-house and enter deals when value maximization and risk reduction can be achieved 8
Slide 9: Expansion of GI Pipeline (1)
Expansion of GI Pipeline (1) Rifamycin • NCE (in US) antibiotic with lower resistance Candidate for 10 years exclusivity under GAIN Act • Indication currently sought: Travellers’ Diarrhoea (TD) Clinical status: Phase III USA completed; Phase III EU in Lat Am ongoing: NDA filing Q 1 2016 • Additional
Slide 10: Expansion of GI Pipeline (2)
Expansion of GI Pipeline (2) Monoclonal antibody MMX • Proven preservation of Infliximab antibody activity in tablets and in colonic environment • Currently developing clinical model in mice • Bio-similar API (Bio-better since not injected) under development • API manufacturing scale up process ongo
Slide 11: Expansion into new therapeutic areas
Expansion into new therapeutic areas Endoscopy Dermatology 11
Slide 12: Endoscopy. A Promising Pipeline
Endoscopy. A Promising Pipeline Two new powerful tools to support endoscopists in their battle against colon cancer Methylene Blue SIC 8000 MMX® 12
Slide 13: Methylene Blue (MB)
Methylene Blue (MB) Revolutionary diagnostic for cancer screening during colonoscopy • Leverages on MMX technology • Delivers the only suitable vital dye to the whole colon • Creates previously unavailable contrast • Significantly increases adenomas detection rate (*) (*) According to phase II clini
Slide 14: MB MMX Main Target
MB MMX® Main Target Diminutive Polyps ˂5 mm in right section of the colon
Slide 15: MB MMX Main Target
MB MMX® Main Target Polyps not otherwise visible
Slide 16: Invisible without MB MMX
INVISIBLE WITHOUT MB MMX® COSMO Pharmaceuticals
Slide 17: MB development timeline
MB development timeline • Phase III ongoing, expanded from 13 sites in US and EU to 20 • Primary endpoint: proportion of subjects with at least one histologically proven adenoma or carcinoma vs. white light endoscopy • 1,270 patients to be treated • Data available H2 2015 • Centralized Registration
Slide 18: MB market potential in US
MB market potential in US • 15 m annual colonoscopies (about 16% of population are in SSRIs) • ~12.6 m available for treatment • Patent granted to 2031 • Price per treatment to be determined • No competing product in the market (spray chromo-endoscopy is not approved) 18
Slide 19: MB market potential in EU & RoW
MB market potential in EU & RoW • ~38 million annual colonoscopies • By 2031 market will grow to ~110 million annual colonoscopies • Approval in EU expected 2016 • Approvals in other markets to be determined • MB is expected to generate higher returns in EU and RoW than in the US 19
Slide 20: After finding it, the lesion must be taken out
After finding it, the lesion must be taken out • The mucosa is between 1-3 mm thick • Taking out GI lesions creates perforation risk • For flat polyps, the operator needs to separate the tissue structures • Current procedure foresees the injection of saline solution or very expensive Hyaluronic Acid
Slide 21: SIC 8000 satisfies an unmet need
SIC 8000 satisfies an unmet need • No products for this indication currently available in the US market: self made mixtures and off-label products currently used • Most commonly used submucosal injectable solution is normal saline, which is cheap, widely available and easy to inject, but dissipates
Slide 22: SIC 8000: making polyp removal faster and safer
SIC 8000: making polyp removal faster and safer • A liquid composition developed as submucosal injection formulation to be used in endoscopic resection procedures in the GI tract • Dyed with methylene blue, so it assists the endoscopist in visualizing the target lesion and performing the resection p
Slide 23: SIC 8000 development timeline
SIC 8000 development timeline • Biocompatibility according to ISO 10993 standard on medical devices completed: raw data showed that SIC 8000 is fully biocompatible. Final reports expected by end of January • 510(k) filing in US scheduled by end Q1 2015 • FDA approval scheduled by end Q2 2015 • Europ
Slide 24: SIC worldwide market potential
SIC worldwide market potential • CRC prevention colonoscopies • 15 m in USA and 38 m in RoW annual colonoscopies • Ratio of colonoscopies requiring SIC not less than 10% in US (although evidence being gathered in current MB trial suggests ratio is higher) • 1-2 10ml vials average requirement per rem
Slide 25: Dermatology: a market with little innovation and many opportunities
Dermatology: a market with little innovation and many opportunities • No NCE in Acne in the US market in the last 15 years • Dermatologists generally prescribe 2-3 products at the same time as they look for new therapeutic options • Historically dermatology has had the lowest product failure rate in
Slide 26: A first class portfolio: CB-03-01 (Acne)
A first class portfolio with very high growth potential 1) CB-03-01 (Acne) • Unique skin penetrating topical anti-androgen for treatment of acne, with innovative mechanism of action, mainly based on sebum production control • Phase II dose ranging study successfully completed in US on 350 patients:
Slide 27: A first class portfolio: CB-03-01 (Alopecia)
A first class portfolio with very high growth potential 2) CB-03-01 (Alopecia) • Only topical anti-androgen for treatment of Androgenetic Alopecia • POC Phase II started in US, 90 patients & 6 months treatment, conclusion by Q4 2015 • Kinetic proof of scalp penetration obtained • Same safety as for
Slide 28: A first class portfolio: CB-06-02 (HPV – Genital Warts)
A first class portfolio with very high growth potential 3) CB-06-02 (HPV – Genital Warts) • Tellurium based compound for treatment of HPV and genital warts • POC Phase II ongoing, completion by Q1 2016 • HPV vaccination is currently in regression because of fertility concerns 28
Slide 29: A first class portfolio: CB-06-01 (Antibiotic for Acne)
A first class portfolio with very high growth potential 4) CB-06-01 (Antibiotic for Acne) • NCE topical antibiotic for Acne, ideal complement for CB-03-01 • Active on most resistant bacterial strains • POC Phase II ongoing, completion by Q1 2016 29
Slide 30: Cosmo's next deals opportunities
Cosmo‘s next deals opportunities Endoscopy SIC (w/w rights) MB (w/w) GI Rifamycin (rights in US and selected RoW countries) Monoclonal Antibody MMX (w/w) Dermatology CB-03-01 for Acne (w/w) CB-03-01 for Alopecia (w/w) CB-06-02 for HPV-Genital Warts (w/w) CB-06-01 for Acne (w/w) 30
Slide 31: Cosmo's 2015 projected clinical news flow
Cosmo‘s 2015 projected clinical news flow Endoscopy SIC: approval MB: end of phase III GI Rifamycin: end of phase III Dermatology CB-03-01 for Acne: start of phase III CB-03-01 for Alopecia: end of POC – phase II 31
Slide 32: Cosmo's next strategic steps
Cosmo‘s next strategic steps • Change of registered office to Luxembourg To increase flexibility, access to capital market and talent recruitment registered office will be moved Q1 2015 (subject to withdrawals not exceeding 600.000 shares; current data shows that only 110’700 shares have been tender
Slide 33: 2014 – 2016 Guidance
2014 – 2016 Guidance EUR/Million E 2014 E 2015 E 2016 Traditional contract manufacturing and other revenue 12 12 12 MMX® products manufacturing 30 34 38 MMX® products royalties 23 (1) 24 (2) 29 (3) MMX® licence fees, up-front fees and milestones 18 - 1 Revenues from products under development - 80 (
Slide 34: Cosmo Pharmaceuticals
Cosmo Pharmaceuticals Information Contacts • Number of shares: 14,418,983 • Alessandro Della Cha , CEO adellacha@cosmopharma.com • Listing: SIX Swiss exchange, Main board • Chris Tanner, CFO ctanner@cosmopharma.com • ISIN: IT0004167463 ph: +39-02-9333’7276 • Giuseppe Cipriano, COO gcipriano@cosmopha
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