Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Investor Day (January 2015)
104 slides from Cosmo Pharmaceuticals Nv's investor day presentation, Jan 30, 2015
Slide 1: R&D Investor Day
R&D Investor Day Lainate January 30, 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 11 12 +9,1% MMX® products, manufacturing 20 30 +50,0% MMX® products, royalties 20 23 +15,0% MMX® licence fees, up-front fees and milestones 5 18 +260,0% TOTAL OPERATING REVENUES 56 83 +48,2%
Slide 4: Cosmo's path to organic growth
Cosmo‘s path to organic growth 1) Expand GI pipeline 2) Expand activities to other therapeutic areas, namely: Endoscopy & Dermatology 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
Slide 5: Two very successful products in the market
Two very successful products in the market Launch in 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 > $ 150 m Patent protection extended from 2020 to 2031 5
Slide 6: Products on the market GI
Products on the market GI e COSMO Pharmaceuticals
Slide 7: Lialda: market projections
Lialda: market projections Lialda/ Mezavant 2015 p 2016 p 2017 p Cosmo Revenues in EUR m 15,7 16,9 17,9 7
Slide 8: Lialda: litigation update
Lialda: litigation update Genericising Lialda is quite challenging • 4 par. IV litigations currently pending (first filed 2010) for counterfeiting/infringement against Zydus/Cadila, Osmotica, Mylan and Watson (now Actavis) • Cosmo/Shire have won in first instance against Watson (now Actavis) as the
Slide 9: Uceris: market projections
Uceris: market projections Uceris 2015 p 2016 p 2017 p royalties & manufacturing income in EUR m 29.9 37.4 43.9 9
Slide 10: Uceris: Santarus/Salix Add-On Study Features
Uceris: Santarus/Salix Add-On Study Features Source CCFA 2014 10
Slide 11: Uceris: Add-On Study Achieving histological healing
Uceris: Santarus/Salix Add-On Study Achieving histological healing Source CCFA 2014 11
Slide 12: Uceris: Cosmo's benefits from Add-On Trial
Uceris: Cosmo’s benefits from Add-On Trial Add-On trial shows that treatment with Uceris in addition to 5-ASA: • is more effective than 5-ASA alone in terms of clinical, endoscopic and hystological remission • allows a much better mucosal healing compared to 5-ASA alone As UC patients are normally f
Slide 13: Uceris: potential expansion beyond UC
Uceris: potential espansion beyond UC • Microscopic Colitis (MC) is an IBD, namely an inflammation of the colon that can be detected only with a microscope • MC stems from an abnormal immune-system response to bacteria normally living in the colon • MC includes collagenous colitis and lymphocytic co
Slide 14: Uceris Patent Protection (2020-2031)
Uceris Patent Protection (2020-2031) FDA Orange Book listing Drug Drug Patent Patent Use Delist Appl No Prod No Patent No Substance Product Expiration Code Requested Claim Claim N203634 001 7410651 Jun Y U - 1325 9,2020 N203634 001 7431943 Jun Y 9,2020 N203634 001 8293273 Jun Y 9,2020 N203634 001 87
Slide 15: Uceris Additional Patent Protection on Pharmacokinetic Parameters
Uceris Additional Patent Protection on Pharmacokinetic Parameters (PK) • US Patent 8,895,064 was granted on November 25, 2014 with claims containing the in vivo pharmakinetics parameters related to the product • It is important to have PK parameters granted in a US patent on an already marketed prod
Slide 16: Uceris additional protection against ANDA Filers
Uceris additional protection against ANDA Filers stemming from new Bio-Equivalence (BE) Guidance • In response to the Citizen Petition filed by Santarus/Cosmo (2013), FDA issued a BE Draft Guidance specific for Uceris (December 2014), requesting two in vivo (pharmacokinetics) and one in vitro testin
Slide 17: Cortiment
Cortiment • Cortiment was successfully launched in The Netherlands in 2013. Market dynamics (units/inhabitants) equal to US • Approval extended in 27 EU countries with MRP concluded in October 2014 • Launch sequence on the basis of National approvals and of price optimization, starting from Q1 2015
Slide 18: Cortiment: RoW approval path
Cortiment: RoW approval path Cortiment marketing authorization application (MAA) already submitted in : • Australia • Israel/Jordan/Kuwait/Lebanon • Brazil • South Africa • Russia • Mexico Submissions in CH, Turkey, UAE, Chile, Canada to follow Expected approvals in 2015: • Australia • Israel/Lebano
Slide 19: Cortiment: market projections
Cortiment: market projections Cortiment 2015 p 2016 p 2017 p royalties & manufacturing income in EUR m 0.7 2.3 5.5 milestones in EUR m 1 • As per units sold, the forecast is in line with US’ (after 3 years from launch, ~12m tablets sold for each of Cortiment and Uceris) 19
Slide 20: ZACOL NMX
ZACOL NMX • Jan-Apr: 3 weeks TV and 3 months radio advertising, highly successful • 90’000 packs sold in the market in the ads period • test confirmed the market need of products to regulate intestinal functions in healthy subjects Next steps: • classification of Zacol as a medical device (ZacolMed)
Slide 21: Products under development GI Pipeline
Products under development GI Pipeline 21
Slide 22: GI Pipeline - Rifamycin
GI Pipeline - Rifamycin NCE (in US) antibiotic with negligible absorption after oral administration and lower possibility of resistance. Candidate for 10 years exclusivity in USA under GAIN Act Indication currently sought: Travellers’ Diarrhoea Clinical status: Two pivotal clinical trials were requi
Slide 23: GI Pipeline - Rifamycin subsequent indications
GI Pipeline - Rifamycin subsequent indications Uncomplicated Diverticulitis • Phase II managed by Falk in Germany, Italy, Hungary and Romania. • approximately 100 patients enrolled. • expansion to other two countries ongoing. Development timeline: interim analysis by end of 2015 IBS • New formulatio
Slide 24: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Target: to deliver MoAb topically in the intestine, in order to avoid toxicity associated with their systemic absorption and reduce immunoreactions Potential indication: Ulcerative Colitis (maintenance of remission), as an ideal follow-up to Uceris-Cortiment/Lialda Evidence: •
Slide 25: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX The colon does not host proteolytic enzymes that may destroy MoAbs * From “METABOLISM” – compiled and edited by Phlip L.Altman and Dorothy S. Dittmer 25 Federation of Amer. Soc. for Exp. Biology
Slide 26: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX MMX® manufacturing process does not degrade or change the structural conformation of MoAbs Tablets manufactured with MMX® technology maintain the antibody binding capacity
Slide 27: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Infliximab extracted from tablets manufactured with MMX® technology maintains the antibody biologic activity LNCaP TNFa-induced cell death inhibited by anti-TNFa 2,E+05 2,E+05 2,E+05 Relative Cell Number 1,E+05 1,E+05 1,E+05 z 8,E+04 6,E+04 MMX-48 4,E+04 MMX-49 Inflix 2,E+04 n
Slide 28: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Infliximab locally delivered in DNB colitis is effective Infliximab 0.008 mg/die Vehicle Intracolon Daily dose Colon weight Mucosal Damage Inhibition P treatment (mg/die) (g) Area (mm2) * (%) Vehicle --- 1.81 ± 0.76 262 ± 209 --- --- Infliximab 0.008 1.62 ± 0.31 88 ± 80 66.73
Slide 29: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Administration of an anti-TNFα soluble receptor into the colonic lumen is effective in reducing the necrosis area in the treated mice 70 58,4 % of inhibition vs baseline 60 49,2 48,6 50 40 30 18,7 20 10 2,24 -5,5 0 0,0008 0,002 0,008 0,04 0,08 0,80 -10 daily topical dose mg
Slide 30: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Interferon MMX tablets match MMX dissolution standards t=0h t=4h t=8h t = 12 h
Slide 31: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Study Aim: show clinical efficacy of topical delivery of MoAb in the intestine Treatment Regimen Infliximab 100 mg/100mL administered as enemas. Three enemas one week apart, on days 0, 7, and 14. Study Duration 42 days Subjects characteristics Four patients presenting with act
Slide 32: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Assessment and assumptions for MMX® application 1- Protein and peptide degrading proteolytic enzymes or peptidases are less abundant in the colon than in the upper GI tract 2 - Drug delivery into the colonic region, also in the left side of it, through MMX® tablets is validate
Slide 33: GI Pipeline - MoAb MMX
GI Pipeline - MoAb MMX Development timeline: • Formulation and analytical development ongoing with model APIs • Generation by AIMM of a series of stable Remicade bio-better clones • AIMM bio-better with physico-chemical and biological properties similar to Remicade (before and after lyophilization)
Slide 34: Products under development Endoscopy Pipeline
Products under development Endoscopy Pipeline 34
Slide 35: Endoscopy Pipeline
Endoscopy Pipeline Two new powerful tools to support endoscopists in their battle against colon cancer Methylene Blue MMX® SIC 8000 35
Slide 36: Endoscopy Pipeline - Methylene Blue MMX (MB)
Endoscopy Pipeline - Methylene Blue MMX (MB) Methylene Blue is used in > 10% colonoscopies via “in situ” spraying onto the colonic mucosa Suspicious area according to endoscopist survey 2-3 fold increased Localized Increased procedure time* and partial Detection [~80$ cost of single use spray cathet
Slide 37: Age
1D Age ex Comment Dr. Facility i-scan 1 @ 00821 (158003) COSMO Pharmaceuticals
Slide 38: Endoscopy Pipeline - MB
Endoscopy Pipeline - MB MB: a revolutionary diagnostic tool for early cancer detection Normal Whole Colon Sharp increase in Procedure stained, Detection Rate, Time overcoming especially for flat/small lesions* * According to Phase II Clinical Data, 51% more polyps and operator 47% more adenomas were
Slide 39: COSMO
39 e COSMO Pharmaceuticals
Slide 40: MB Main Target
MB Main Target Polyps not otherwise visible
Slide 41: MB Main Target
MB Main Target Polyps not otherwise visible
Slide 42: Invisible without MB
COSMO Pharmaceuticals
Slide 43: Endoscopy Pipeline - MB development timeline
Endoscopy Pipeline - 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 within H1 2015 • Data avai
Slide 44: MB Phase III Clinical Trial Sites: EU
Dr. Alessandro Repici, Istituto Clinico 310 Humanitas Rozzano, Italy MB Phase III Clinical Trial Sites: EU Dr. Renato Cannizzaro, Centro di 330 Riferimento Oncologico Aviano, Italy 730 Dr. Ralph Kiesslich, Klinikum der Landeshauptstadt Wiesbaden und der 431 HELIOS Kliniken Gruppe 610 611 Drittmittel
Slide 45: MB Phase III Clinical Trial Sites: North America
MB Phase III Clinical Trial Sites: North America Dr. Michael Wallace 130 Mayo Clinic Jacksonville, FL Dr. Prateek Sharma 131 University of Kansas School of Medicine, Kansas City, MO 111 230 Dr. Francisco Ramirez 110 Mayo Clinic, Scottsdale, AZ Prof David Bruining 112 132 111 131 Mayo Clinic, Rochest
Slide 46: Endoscopy Pipeline MB market potential estimate
Endoscopy Pipeline MB market potential estimate 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% 2
Slide 47: Endoscopy Pipeline - SIC
Endoscopy Pipeline - SIC After the lesion is found, it must be removed 47 Total time for lesion removal: 40 minutes
Slide 48: Polyps removal techniques: EMR
Endoscopy Pipeline - SIC Polyps removal tecniques Endoscopic Mucosal Resection (EMR) • Most commonly used technique for the removal of mucosal lesions, smaller than 2 cm, or piecemeal removal of larger lesions (> 2 cm) • A cushion is needed to lift the lesion and facilitate its removal, minimizing t
Slide 49: Polyps removal techniques: ESD
Endoscopy Pipeline – SIC Polyps removal tecniques Endoscopic Submucosal Dissection (ESD) • Developed specifically for removing larger lesions (> 2 cm) • Predicted to replace conventional surgery • Higher rate of perforation and bleeding complications • Submucosal injection is essential in ESD, and a
Slide 50: Endoscopy Pipeline - SIC
Endoscopy Pipeline - SIC • To avoid risk of perforation, particularly for flat polyps, endoscopists need to create a ’’safety cushion‘‘ between the lesion and the deep layers of the GI wall • Current procedures foresee the injection of normal saline solution, which is easy to inject but dissipates q
Slide 51: Endoscopy Pipeline - SIC
Endoscopy Pipeline - SIC • SIC 8000 (SIC) is a Submucosal Injectable Composition, easy to be injected, developed to be used in endoscopic resection procedures in the GI tract • SIC creates a long lasting cushion which is essential for a successful Endoscopic Mucosal Resection (EMR) or Endoscopic Sub
Slide 52: SIC satisfies an unmet need
Endoscopy Pipeline - SIC SIC satisfies an unmet need • No products for this indication currently available in the US market • Most commonly used submucosal injectable solution is normal saline, but several injections needed to maintain the cushion • Hyaluronic acid solutions are known to be long las
Slide 53: Endoscopy Pipeline – SIC Practical application
Endoscopy Pipeline – SIC Practical application 53
Slide 54: Endoscopy Pipeline – SIC Practical application
Endoscopy Pipeline – SIC Practical application 54
Slide 55: Endoscopy Pipeline – SIC Practical application
Endoscopy Pipeline – SIC Practical application 55
Slide 56: SIC Development as agreed with FDA is completed
Endoscopy Pipeline – SIC Development as agreed with FDA is completed • 3 biocompatibility studies (as per ISO 10993 standard) In vitro cytotoxicity Acute intracutaneous reactivity study in rabbits Delayed dermal sensitization in guinea pigs Biocompatibility studies demonstrated that SIC 8000
Slide 57: Endoscopy Pipeline - SIC Development Timeline
Endoscopy Pipeline - 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 scheduled by end Q1 2015 • FDA approval scheduled by end Q2 2015 • European CE mark filin
Slide 58: SIC market potential estimate (colonoscopies only)
Endoscopy pipeline: SIC market potential estimate (colonoscopies only) 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
Slide 59: SIC market potential (additional indications)
Endoscopy pipeline: SIC market potential (additional indications) The tissues of the esophagus, stomach and duodenum are quite similar to those of the colon. Inspection of these three tracts is conducted by Esophagogastroduodenoscopy (ECG). SIC can be used in all these tracts. As many ECGs are perfo
Slide 60: SIC Additional Indications - Stomach
Endoscopy Pipeline – SIC Additional Indications - Stomach 60
Slide 61: SIC Additional Indications - Esophagus
Endoscopy Pipeline – SIC Additional Indications - Esophagus 61
Slide 62: Products under development Dermatology Pipeline
Products under development Dermatology Pipeline 62
Slide 63: Dermatology pipeline
Dermatology pipeline Product Pre-clinical Phase I Phase II Phase III MA Launch CB-03-01 ACNE CB-03-01 ALOPECIA CB-06-02 AS 101 CB-06-04 ACNE ANTIBIOTIC
Slide 64: 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 65: Acne market dynamics & opportunity
Dermatology Pipeline Acne market dynamics & opportunity 85% of all persons age 12-24 get acne, characterized as a chronic disease In US 17 m person have acne, 35 m prescriptions are written p.a. primarily generics as there are no new drugs WW market ~ $ 3 b; US Market at $ 2.3 b, growing by ~ 1% p.a
Slide 66: Dermatology pipeline – CB-03-01 (Acne)
Dermatology pipeline – CB-03-01 (Acne) CB-03-01 (Cortexolone 17α-propionate) is a NCE with a new mechanism of action, acting on the sebum secretion control. It can prevent the cascade of physiological events: follicle closure by sebum overproduction -> colonization by Prop. acnes -> Inflammation tha
Slide 67: CB-03-01 (Acne) Phase II overview
Dermatology pipeline – CB-03-01 (Acne) Phase II overview Phase II dose ranging trial completed in US 360 patients – 4 doses + vehicle Best dose identified (1% BID) No adverse events 67
Slide 68: CB-03-01 (Acne) Phase II overview
Dermatology pipeline – CB-03-01 (Acne) Phase II overview • CB-03-01 is a NCE • FDA requires at least 1000 patients treated for safety evaluation • 110 patients treated in Phase I/IIa • 290 patients treated in Phase IIb • Primary Endpoints: reached • 700 treated patients planned for Phase III (2 pivo
Slide 69: CB-03-01 (Acne) Phase II overview
Dermatology pipeline – CB-03-01 (Acne) Phase II overview statistical significance in IGA improvement (co-primary endpoint) BID 1.0% VEHICLE P value cream ITT % % 2-Point Improvement 17.1% 6.7% 0,0321 No Change 35.7% 61.3% PP % % 2-Point Improvement 21.8% 8.5% No Change 23.6% 59.3% 69
Slide 70: CB-03-01 (Acne) Phase II overview
Dermatology pipeline – CB-03-01 (Acne) Phase II overview CB–03–01 Phase II: statistical significance in total lesion count (co-primary endpoint) CB-03-01 1% cream VEHICLE P-value BID ITT MEAN -35.7% -13.1% 0.0173 70
Slide 71: CB-03-01 (Acne) Phase II overview
Dermatology pipeline – CB-03-01 (Acne) Phase II overview successful also in secondary endpoint showing reduction in Inflammatory Lesion Counts CB-03-01 1% cream BID VEHICLE P-value* ITT % % MEAN -37.2% -27.0% 0.0384 * Kruskal Wallis test 71
Slide 72: CB-03-01 (Acne) Phase II overview
Dermatology pipeline – CB-03-01 (Acne) Phase II overview successful also in secondary endpoint showing reduction in Non-Inflammatory Lesion Counts CB-03-01 1% cream VEHICLE P-value BID ITT MEAN -32.9% -16.1% 0.0178 72
Slide 73: CB-03-01 (Acne) Development timeline
Dermatology pipeline – CB-03-01 (Acne) Development timeline • EOP2 achieved on Jan 28th • Special Protocol Assessment to be discussed with FDA in Q2 2015 • Phase III trials program: - 2 pivotal trials (US + EU) with > 700 patients/each FPI in Q3 15 LPO in Q1 17 - 1 extension trial - data available Q
Slide 74: Alopecia market dynamics & opportunity
Dermatology Pipeline Alopecia market dynamics & opportunity 20% of all men and 10% of all women between 20-64 lose part of their hair ~ 17% of persons affected use at least one substance • <1% of affected men and women have done hair transplants • <1% of affected men and 5% of affected women use hai
Slide 75: Dermatology Pipeline – CB-03-01 (Alopecia)
Dermatology Pipeline – CB-03-01 (Alopecia)
Slide 76: Dermatology Pipeline – CB-03-01 (Alopecia)
Dermatology Pipeline – CB-03-01 (Alopecia) Rinaldi 2010 - International Hair Research Foundation (IHRF) 76
Slide 77: Dermatology Pipeline – CB-03-01 (Alopecia)
Dermatology Pipeline – CB-03-01 (Alopecia) Rinaldi 2010 - International Hair Research Foundation (IHRF) 77
Slide 78: Dermatology Pipeline – CB-03-01 (Alopecia)
Dermatology Pipeline – CB-03-01 (Alopecia) Rinaldi 2010 - International Hair Research Foundation (IHRF) 78
Slide 79: Dermatology Pipeline – CB-03-01 (Alopecia)
Dermatology Pipeline – CB-03-01 (Alopecia) Rinaldi 2010 - International Hair Research Foundation (IHRF) 79
Slide 80: Dermatology Pipeline – CB-03-01 (Alopecia)
Dermatology Pipeline – CB-03-01 (Alopecia) • Only topical anti-androgen for treatment of Androgenetic Alopecia (Propecia® is a tablet) • Kinetic proof of scalp penetration obtained • Same mechanism and safety as for acne 80
Slide 81: CB-03-01 (Alopecia) Development timeline
Dermatology Pipeline – CB-03-01 (Alopecia) Development timeline • POC Phase II ongoing in USA: 90 patients, double blind, 3 parallel arms, placebo and Minoxidil controlled, 26 weeks of treatment, endpoints on scalp darkness and patient satisfaction. • The Modified Norwood-Hamilton Scale is used to a
Slide 82: CB-06-02 (HPV) market dynamics & opportunity
Dermatology Pipeline – CB-06-02 (HPV) market dynamics & opportunity >20 m persons are infected with HPV in the US, around 1% of sexually active persons in US have visible external genital warts (AGW) HPV can lead to cancer and should be eradicated In western countries many young children are vaccina
Slide 83: Dermatology Pipeline – CB-06-02 (HPV)
Dermatology Pipeline – CB-06-02 (HPV) • Anogenital warts (AGWs) is a common, highly infectious disease caused by the human papillomavirus (HPV) • Tellurium based compound for treatment of HPV and genital warts • HPV vaccination is currently in regression because of fertility concerns 83
Slide 84: Dermatology Pipeline – CB-06-02 (HPV)
Dermatology Pipeline – CB-06-02 (HPV) American family Physician December 15, 2004, 70 (12) 84
Slide 85: CB-06-02 (HPV) Development timeline
Dermatology Pipeline – CB-06-02 (HPV) Development timeline • POC Phase II ongoing in Israel on 30 + 30 patients, double blind, parallel arms, 12 weeks of treatment + 3 months of follow up, endpoints on remission and recurrence rates • Trial Completion foreseen by Q1 2016 85
Slide 86: Dermatology Pipeline – CB-06-01 (Acne)
Dermatology Pipeline – CB-06-01 (Acne) • Topical antibiotic for the treatment of Acne • Ideal complement to CB-03-01 • NCE with very potent and selective properties • Effective with bacterial strains resistant to other antibiotics 86
Slide 87: CB-06-01 (Acne) Antibacterial spectrum
Dermatology Pipeline – CB-06-01 (Acne) Antibacterial spectrum 87
Slide 88: CB-06-01 Activity against antibiotic-resistant P. acnes
Dermatology Pipeline – CB-06-01 (Acne) Activity against antibiotic-resistant P. acnes 88
Slide 89: CB-06-01 (Acne) Development timeline
Dermatology Pipeline – CB-06-01 (Acne) Development timeline • POC Phase II ongoing with a gel formulation, completion by Q1 2016 89
Slide 90: Cosmo Corporate Matters
90 Cosmo Corporate Matters armaceutica
Slide 91: No impact of FX turmoil on Cosmo
Cosmo Corporate Matters No impact of FX turmoil on Cosmo No costs in CHF Only 9% of costs in $, rest in EUR 49% of revenues in $; 51% in EUR All liabilities are in EUR 91
Slide 92: Cash & Liquid Investments
Cosmo Corporate Matters Cash & Liquid Investments as of 1/12/2015 EUR 123.6 m USD 63.7 m 92
Slide 93: Financial position
Cosmo Corporate Matters Financial position 35,7 m 151,5 m cash investments 74% in EUR; 64% in EUR 26% in $ 36% in $ 11 m debt 100% in EUR 93
Slide 94: Completed Capital Reduction
Cosmo Corporate Matters Completed Capital Reduction • annullment of 576’760 shares • total capital unchanged by increasing nominal value per share from EUR 0.25 to EUR 0.26 • Total shares outstanding now 14’418’983 shares • Accretion of 4% which is an implicit dividend 94
Slide 95: Next Strategic Steps
Cosmo Corporate Matters Next Strategic Steps • Change of registered office to Luxembourg • Set-up of second plant in Ireland • Potential strategic spin-off of derma franchise by means of IPO or private placement • Initiate discussion for deals re pipeline products • evaluate possibility of setting u
Slide 96: Transfer of Seat to Luxembourg
Cosmo Corporate Matters Transfer of Seat to Luxembourg • Filing for registration in Luxembourg early February • Registration takes place in 10-20 days • After registration in Luxembourg, filing for cancellation in Italy 96
Slide 97: Consequences of shareholders' withdrawal
Cosmo Corporate Matters Consequences of shareholders‘ withdrawal • 104’931 shares put to the company at CHF 156.03 • shareholders who have tendered shares will receive payment value May 5, 2015 • shareholders who did not tender shares have pre-emptive rights to purchase tendered shares at CHF 156.03
Slide 98: Second Plant in Ireland
Cosmo Corporate Matters Second Plant in Ireland • a second FDA approved plant is being built in Dublin, Ireland • Scope: • ensure production continuity • enhance manufacturing franchise • grant second line of supply to strategic partners • Plant will occupy a newly constructed “shell” bordering Dubl
Slide 99: Second Plant in Ireland - Features
Cosmo Corporate Matters Second Plant in Ireland - Features • 3’000 sqm surface, 12m height • MMX tablets production line (500k batch size) + bottle and blister packaging lines • expected timeline: • Q1 2015 planning permission filing • Q4 2015 fit-out works start, around 12 months duration • H2 2017
Slide 100: Potential IPO of Cosmo Derma
Cosmo Corporate Matters Potential IPO of Cosmo Derma • Newco is being set up • Newco to be funded by Cosmo Pharma • Plan to list on SIX • Plan to give existing Cosmo Pharma shareholders pre-emptive rights 100
Slide 101: Next Deals Opportunities
Cosmo Corporate Matters 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) 101
Slide 102: 2015 Projected Clinical News Flow
Cosmo Corporate Matters 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 102
Slide 103: 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 104: 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