new jefferies global health care conference london november 19/media/files/c/cosmo... · 2015. 6....
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Jefferies Global Health Care Conference
New YorkJune 3, 2015
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Safe HarbourThis 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 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 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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Cosmo’s simple business philosophy …
• Leverage on internal know-how
• Keep overheads low and small & flexible managerial infrastructure
• Develop proprietary R&D
• Retain manufacture of own products
• Combine optimal returns while minimizing risk in deal structuring
Last 3 Years Market Cap Performance(1)
........has created substantial value over time
Key Milestones
2007: IPO in SIX, with a market cap of CHF195m
2007: Launch of first product Lialda®
2008: Licensing deals with Santarus and Ferring
2012: Winlevi®
licensing deal with Medicis (now Valeant)
2013: sale of first part of SNTS shares
2014: sale of last part of SNTS shares
2014: repurchase of CB-03-01 license from Valeant
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500
1.000
1.500
2.000
2.500
3.000
mag-12 nov-12 mag-13 nov-13 mag-14 nov-14 mag-15
(CHFm)
Last 3 years:+558%
15-Jan-13Licensee Santarus receives FDA approval for UCERIS®
10-May-13First sale of Santarus stake
8-Nov-13Salix / Santarus merger announced
9-Jul-14Salix tax inversion into Cosmo announced
3-Oct-14Salix tax inversion terminated
30-Jan-15Announced Cassiopea listing
(1) Company website and Capital IQ as of May 7th, 2015.
2-Jan-14Sale of remaining stake in Santarus
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• Lialda
• Uceris
The MMX technology has led to two very successful products
Launch 2007
First year sales $ 50 m
Second year sales $ 140 m
2014 sales $ 634 m
Launch 2013
First year sales $ 66 m
Second year sales $ 152 m
Patent extended from 2020 to 2031
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...and provided the base for a distinct growth strategy
1) Expand GI pipeline
2) Expand activities to other therapeutic areas
3) Consider further “equity for product” deals
4) Create as much value as possible in-house and enter into deals when value risk ratio is best
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expanding the GI Pipeline with a new antibiotic
Rifamycin MMX
• 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 Amongoing: NDA filing targeted for Q 1 2016
• Additional indication under development by Dr. Falk: Uncomplicated Diverticulitis
Clinical status: Phase II ongoing, multi-centre trial, interimanalysis scheduled end 2015
• Subsequent indication: IBS
different strength tablet; Clinical status: PK study applicationfiled
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...and a tabletized anti TNF
Monoclonal antibody MMX
• Proven preservation of Infliximab antibody activity in tablets and incolonic environment
• Currently developing clinical model in mice
• Bio-similar API (Bio-better since not injected) under development
• API manufacturing scale up process ongoing
• Phase I/II trial to begin in 2015
• Potential indication: Ulcerative Colitis (maintenance)
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and provided the impetus for expanding into Endoscopy
Two new powerful tools to support endoscopistsin their battle against colon cancer
Methylene Blue MMX®
SIC 8000
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Current spray chromoendoscopy procedure
Methylene Blue is used in > 10% colonoscopies
via “in situ” spraying onto the colonic mucosa
*ASGE Volume 66, No 4: 2007 GASTROENINTESINAL ENDOSCOPY. Clinical Trial showed increased detection rate with Indigo Carmine.
2-3 fold increased procedure time*[~80$ cost of single use spray catheter]
Localized and partial staining*
Suspicious area according to endoscopistsurvey
Increased Detection Rate in the area*
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MB tablets address an unmet need
MB: a revolutionary diagnostic tool for early cancer detection
* According to Phase II Clinical Data, 51% more polyps and47% 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*
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Methylene Blue (MB) tablets
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 (*)
• colon dyed prior to colonoscopy, so significant time saving
(*) According to phase II clinical data, 51% more polyps and 47% more adenomas were found with MB than in ordinary colonoscopy literature data
MB MMX® Main Target
Diminutive Polyps ˂5 mm
in right section of the
colon
MB MMX® Main Target
Polyps not otherwise
visible
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MB development timeline
• Phase III ongoing, expanded from 13 sites between 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 end 2015
• Centralized Registration Application granted in EU under EMA
• Special Protocol Assessment (SPA) granted by FDA
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High cost of colonoscopies in the US; high cost for adenoma detection
MB Market potential 2017 2018 2019 2020 2021
non SSRI colonoscopies in US in m 12.6 12.8 12.9 13.1 13.2
market penetration 5% 10% 15% 20% 20%
minimum price 120 120 120 120 120
colonoscopies in EU 17.4 17.6 17.8 18.0 18.3
market penetration 5% 10% 15% 20% 20%
minimum price 50 50 50 50 50
colonoscopies in RoW 24.8 26.8 29.0 31.5 34.2
market penetration 0% 2,5% 5,0% 7,5% 10,0%
minimum price 30 30 30 30 30
total revenues in EUR m 119.1 261.2 409.6 564.8 602.4
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MB market potential estimate
Identified lesions must be removed
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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 submucosa
Capture with the snare
Removal
Endoscopic Mucosal Resection (EMR)
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Circumferential injections Mucosal elevation Submucosal 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
Endoscopic Submucosal Dissection (ESD)
larger lesions (>2 cm) require refined techniques:
Current mechanism to create safety cushion
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• normal saline solution is easy to inject but dissipates quickly
• expensive Hyaluronic Acid solutions or self made cocktails, both non approved in US
• low viscosity to facilitate injection
• long lasting cushion (> 30 min)
• Include a dye to enhance borders definition
• be safe and bio-compatible
• Affordable in terms of pricing
Requirements of the ideal submucosal injectable
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• SIC 8000 (SIC) is a Submucosal Injectable Composition, easy to be injected, developed to be used in all endoscopic polyp removal procedures in the GI tract
• SIC creates a long lasting cushion which is essential for a successful Endoscopic Mucosal Resection (EMR) or Endoscopic SubmucosalDissection (ESD)
• SIC is dyed with methylene blue, so it helps in visualizing the lesion and performing the resection procedure, minimizing risk of perforation
• SIC is covered by two international and one US patent applications filed in 2014 (priority 2013)
Submucosal injectable composition SIC 8000
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SIC Development Timeline
SIC is a medical device classified as a class II medical device in US and as either a class IIa or IIb medical device in EU
Approval timeline:
• 510(k) filing in US made on March 31, 2015
• FDA approval scheduled for June/July
• European CE mark filing scheduled by Q2 2015
• European approval scheduled by Q4 2015
SIC market estimates 2016 2017 2018 2019 2020
polyps/adenomas per colonoscopy in phase II 1,75 1,75 1,75 1,75 1,75
% of polyps/ adenomas removal requiring SIC 20% 20% 20% 20% 20%
Minimum vials per colonoscopy 1,5 1,5 1,5 1,5 1,5
estimated price in US 100 100 100 100 100
market penetration in US 10% 20% 30% 40% 50%
estimated price in EU 40 40 40 40 40
market penetration in EU 7% 15% 25% 30% 30%
estimated price in RoW 30 30 30 30 30
market penetration 3,5% 7,5% 12,5% 15,0% 15,0%
Revenue (millions) 68,5 143,1 227,8 298,6 353,6
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SICmarket potential estimate (colonoscopies only)
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market potential from additional indications
• Esophagus, stomach and duodenum have similar tissues as the colon
• Inspection by Esophagogastroduodenoscopy (ECG)
• SIC can be used in all these tracts
As many ECGs are performed as colonoscopies, both in the US and Europe.
•During ECG, removal of tissues/polyps is frequently necessary and will require SIC as per below examples:
Barrett Esophagus
• Caused by GERD, ~ 1,6% of population affected
• Requires an ECG every 3 years
• Tissue removal required in ~ 10% all cases
Stomach & duodenal polyps
• polyps requiring extraction are found in around 0,7% of all procedures
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Cosmo is currently pursuing a Swiss IPO of its dermatology division
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Cosmo’s strategic aims for a Cassiopea IPO
• Best equity-for-product strategy is an in-house transaction
• Ability to recruit specific derma talents with dedicated Company
• Ability to remunerate specific performance with a dedicated ESOP
• Ability to purchase companies & business with Cassiopea shares
• Set-up of dedicated US commercial infrastructure when appropriate to retain maximum value in the most important derma market
Confidential
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Expected main features in Cassiopea’s IPO
• Listing SIX
• Timing Targeted in 2015
• Structure Cosmo will fund the company prior to listing
all secondary
target retaining less than 50%
• Investors expected support from core Cosmo investors
Multiple catalysts and anticipated value inflection milestones on the horizon
Exclusive focus on dermatology: a large specialty-driven market with little innovation and with unmet medical needs in Acne and Alopecia
Four unencumbered products with novel mechanisms of action
Winlevi® in Phase III(2) with statistical significance shown in Phase II
Strong barriers to entry
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Key Investment Highlights
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Cassiopea is a clinical-stage specialty pharmaceutical company focusing on developing and commercializing innovative and differentiated medical dermatology products
Winlevi® – Lead NCE for Acne(1)
Breezula® – NCE for Alopecia(1)
CB-06-01 – NCE Antibiotic for Acne
CB-06-02 – NCE for HPV
(1) Winlevi® and Breezula® are different formulations of the same NCE, for different indications.
(2) Special Protocol Assessment submitted to the FDA in April 2015.
A totally independent team has been put together to lead this project
Management TeamBoard of Directors
Jan de Vries, PhD
Chairman
Head of Novartis Institutes for Biomedical Research 2008-2010; Head of Novartis Autoimmunity, Transplantation and Inflammation 1997-2008
David Hale
Independent Director
Former Chairmanships at Santarus, SkinMedica, Micromet, Somaxon, Crisi Medical Systems, Viagene
Øyvind Bjordal
Independent Director
Managing Director and Head of Switzerland of Lincoln International
Former Investment Banker at Leonardo, Sal. Oppenheim & UBS
Pierpaolo Guzzo
Independent Director
CEO of EQValue (Italy) and charteredaccountant
Former Director of PM & Partners SpA
Diana Harbort
CEO and Director
Formerly VP Corporate Development at Medicis 2005-2012; Director Business Development at Medicis 1999-2004; various functions at Abbott, 1989-1998; MBA from Kellogg
Louise Dube, PhD
Director of R&D
Director of Scientific Assessment at Medicis 2007-2012; various functions at Abbott, 1987-2001; PhD Pharmacokinetics from Purdue
Diane Goostree
Head of Program Management
Former CEO of Intrepid Therapeutics; President & CEO of Artes Medical, 2006; Business Development roles at SkinMedica and Elan 2000-2006
Business Development and Sales Management at Dura Pharma and Sanofi Aventis 1984-2000; MBA from Missouri
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Cassiopea has a balanced pipeline in large markets
ProductPre-Clinical
Phase I Phase II Phase IIIMA /
Expected Launch
Next Catalyst
Market Opportunity
Winlevi®ACNEAnti-androgenNCE(1)
2018
H2 2015 (PIII FPI) H1 2017
(PIII LPO)
US only:$5bn(2)
Breezula®
ALOPECIAAnti-androgenNCE(1)
2021H2 2015
(Phase II)
$1.9bn(3)
(surgical)
$600m(4)
(drugs)
CB-06-01ACNEAntibioticNCE
2021H1 2016(POC)
US only:US$5bn(2)
CB-06-02HPVIntegrin activatorNCE
2021H1 2016(POC)
US only:c.14m new infections
each year(5)
H2 2017
POC H2 2015
DR H2 2017
DR H2 2017
H2 2019
H2 2019POC H1 2016
POC = Proof of ConceptDR = Dose Ranging
H2 2019POC H1 2016
DR H2 2017
(1) Winlevi® and Breezula® are different formulations of the same NCE, for different indications.(2) Management estimates based on IMS Health, IMS SMART MVP Solutions. Comprised of USC3 Classification 37100 Acne Therapy,
Prescription Only, plus antibiotics Doryx, Monodox, Solodyn and Tazorac – Manufacturing prices increased by 20%.(3) International Society of Hair Restoration Surgery. Note: 2012 survey figure.(4) EvaluatePharma.(5) Centers for Disease Control and Prevention.
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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 clinical trials
• Probability of success in phase III clinical trials is high
• Market has important cosmetic and life-style implications
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a novel very high potential acne drug
• 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: - Best dose identified- No adverse events (>500 patients tested)- Statistical superiority attained
• EOPII meeting with FDA on January 28
• Phase III trial scheduled to start H1 2015
• Innovative trial design with support of top KOLs (IGA reduction and total lesion count)
®
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a novel very high potential alopecia drug
• 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 acne
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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
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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
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EUR/Million 2014 E 2015 E 2016
Traditional contract manufacturing and other revenue 11 11 11
MMX® products manufacturing 29 35 38
MMX® products royalties 21 (1) 24 (2) 29 (3)
MMX® licence fees, up-front fees and milestones 18 - 1
Revenues from products under development - 80 (4) 163 (4)
Total Revenues 80 150 243
Operating expenses (49) (5) (54) (5) (67) (5)
EBITDA 31 96 176
Depreciation and amortization (9) (9) (3)
Operating result 23 87 173
Sale of "equity for product" stake 65 (6)
Salix termination fee 17 - -
Net financial income 3 3 6
Profit before taxes 111 90 179
Potentially replaceable with “equity for product” transactions respectively IPO value gains
(1) includes EUR 5.7 M royalties on Lialda/Mezavant: royalty cap reached in 2Q 2014
(2) includes EUR 23,4 M roy on Uceris/Cortiment
(3) includes EUR 28,4 M roy on Uceris/Cortiment
(4) assumes MB and SIC are licensed in 2015 and Rifamycin is licensed in US in 2016
(5) includes SOP and profit bonus
(6) gain on sale of SNTS shares
2014 – 2016 Guidance
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Cosmo Pharmaceuticals
Information Contacts
• Number of shares: 14,418,983
• Listing: SIX Swiss exchange, Main board
• ISIN: LU1202320294
• Alessandro Della Cha , [email protected]
• Chris Tanner, [email protected]
• Giuseppe Cipriano, [email protected]
• Luigi Moro, [email protected]