Jefferies Global Health Care Conference. London 14. November 2012

Transcription

1 Jefferies Global Health Care Conference London 14. November

2 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 MMX, Methylene Blue MMX and CB 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. 2

3 Financial development since IPO EUR million e Revenues 15,2 33,5 59,6 R&D Cost 3,9 5,2 12,4 Total Cost 13,8 24,6 32,9 Operating Result 1,4 8,9 26,7 Net Income -0,3 7,6 19,3 Cash & Financial Assets 2,3 31,9 65,2 Inventory & Receivables 4,1 8,4 8,7 Total Assets 25,3 78,0 110,3 Equity 4,7 63,1 95,5 Debt 10,7 2,1 1,3 Payables 4,9 4,1 4,2 Other liabilities 5,0 8,7 9,3 3

4 Cosmo s share price development compared to the SPI and the SXI Life Sciences Index 4

5 Cosmo s share price development in EUR/GBP/USD 12/03/ /10/2012 Increase Closing price CHF 22,30 28,25 26,7% FX EUR 13,82 23,39 69,3% FX GBP 9,43 18,87 100,1% FX USD 18,18 30,40 67,2% 5

6 First MMX product in the market: Lialda million Market revenues in $ m Growth 180% 69% 24% 27% Royalties for Cosmo 1,2 3,5 6,0 8,5 10,0 Manufacturing Income for Cosmo Total Lialda Income for Cosmo 2,7 7,1 6,8 7,7 10,8 3,9 10,6 12,8 16,2 20,8 Growth 172% 21% 27% 28% Indicated for Patients with Ulcerative Colitis of mild to moderate severity Shire Analysts project Lialda Net Sales for 2012 to increase by 13% to $ 422 m In H1 Cosmo generated Lialda Income of 13.2 m 6

7 Budesonide MMX : Uceris and Cortiment The clinical endpoints were the most severe of all trials for mild to moderate UC to date: Remission defined as UCDAI 1; stool frequency score 0, rectal bleeding score 0, mucosal appearance score 0, physician rating max 1 2 full colonoscopies Population selection based on independent assessment of active inflammation through histology at trial entry Remission was attained in 17.4% vs 4.5% placebo in EU, 17.9% vs 7.4% placebo in the USA. Statistical significance attained in both trials Odds ratio of 4.48/2.71 (Lialda = 2.40) Summary of adverse events treatment related was practically identical to placebo Extension (12-month) trial using Budesonide MMX 6 mg confirmed very good safety results MEB decision to decline approval for lacking clinical relevance is being appealed PDUFA date January 16, 2013 Unlicensed in Japan 7

8 Rifamycin SV MMX : Status and Opportunities Indication Travellers and Infectious Diarrhoea Status US phase III clinical trial run by Santarus attained clinical endpoints N=264; TLUS of 46 hrs vs 68 hrs for placebo; p= Well tolerated, no major adverse events Phase III trials in EU run by Dr. Falk Pharma ongoing Opportunities EU trail is for non inferiority to Cypro; 1000 patients: Completion expected Q 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 Second indication will be selected this year Unlicensed in Asia, Africa, Latin America 8

9 Colon cancer diagnosis: current alternatives FOBT Low cost test that detects blood in the stool Does not pin point location DNA tests High cost stool test ($350-$800) which analyses cells shed from the lining of the colon. Cannot pin point location ie mark it Considered experimental and is not reimbursed by health insurance in the US Colonoscopy is the best diagnostic according to American Society of Gastroenterologists Reimbursed by health insurance in the US With proper pre screening 75%-90% of all colon cancer could be avoided 9

10 Different kinds of colonoscopy White light colonoscopy is the standard treatment Skills and experience of colonoscopist are essential Up to 1/3 of all polyps <10 mm are not detected 6 fold range of adenoma detection rate amongst colonoscopists National Health Agencies recommend the use of visual enhancers As optics (High definition scopes) and lighting (narrow band imaging and different color filters) improve, detection rates increase Chromoendoscopy, or chromoscopy, refers to the topical application of dyes at the time of endoscopy in an effort to enhance tissue characterization, differentiation, or diagnosis. 10

11 11 Identifying dysplasia via Chromoendoscopy

12 Chromoendoscopy is not routinely used No stains are cleared by FDA for chromoendoscopy Stain preparation and dilution of the stock solution must be done in house Costly Mainly performed in hospitals Duration of chromoendoscopy is ~ 2 x duration of white light colonoscopy A spray catheter must be used In sum Single use spray catheter costs ~$ 81 in USA, 40 in UK A dwell time of 1-2 minutes is necessary Excess dye must be removed with water Effective where applied Still subjective Tedious, messy & time consuming (doubles standard time) Considered experimental and not always reimbursed 12

13 Opportunity for MMX application of diagnostic coloring agent Chemical entity Cosmo analysis identifies a new formulation of Methylene Blue as best coloring agent Mechanism of action depicts cellular structures in the mucosal (gut) tissue Indication Colon cancer diagnostic IBD patients have a higher incidence of colon cancer Advantages Taken pre colonoscopy, stains the entire colon, increases yield on identifying mucosal lesions substantially 13

14 14 Methylene Blue application with MMX tablets

15 Study CB-17-01/05: DETECTION RATES Number and proportion of subjects with detected polyps, adenomas and serrated lesions by colonic region in the FAS population (N=96) Methylene blue MMX tablets Population Colonic region 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) Right colon 32 (33.3) 24 (25.0) 9 (9.4) FAS (N=96) 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) 15

16 % of subjects with detected polyps, adenomas and serrated lesions by colonic region 12,5% polyps; 8,3% adenomas, 4,2% serrated lesions 6,3% polyps; 5,2% adenomas, 0% serrated lesions 9,4% polyps; 7,3% adenomas, 2,1% serrated lesions 16,7% polyps; 10,4% adenomas, 5,2% serrated lesions 7,3% polyps; 4,2% adenomas, 3,1% serrated lesions 16 14,6% polyps; 13,5% adenomas, 2,1% serrated lesions 20% polyps; 9,4% adenomas, 15,5% serrated lesions 22% polyps; 12,5% adenomas, 8,3% serrated lesions

17 % of subjects with detected polyps, adenomas and serrated lesions by colonic region 12,5% polyps; 8,3% adenomas, 4,2% serrated lesions 6,3% polyps; 5,2% adenomas, 0% serrated lesions 9,4% polyps; 7,3% adenomas, 2,1% serrated lesions 31% of all adenomas detected in the right colon 16,7% polyps; 10,4% adenomas, 5,2% serrated lesions 7,3% polyps; 4,2% adenomas, 3,1% serrated lesions 17 14,6% polyps; 13,5% adenomas, 2,1% serrated lesions 20% polyps; 9,4% adenomas, 15,5% serrated lesions 22% polyps; 12,5% adenomas, 8,3% serrated lesions

18 Study CB-17-01/05: Detection by size Proportion of subjects with detected polyps, adenomas and serrated lesions by size in the FAS population (N=96) Lesion size Subjects with at least one polyp n (%) Subjects with at least one adenoma n (%) Subjects with at least one serrated lesion n (%) 5 mm 50 (52.1) 30 (31.3) 23 (24.0) 6-9 mm 12 (12.5) 10 (10.4) 3 (3.1) 10 mm 24 (25.0) 22 (22.9) 3 (3.1) 18

19 Study CB-17-01/05: Detection by size Proportion of subjects with detected polyps, adenomas and serrated lesions by size in the FAS population (N=96) Lesion size Subjects with at least one polyp n (%) Subjects with at least one adenoma n (%) Subjects with at least one serrated lesion n (%) 5 mm 50 (52.1) 4030 (41.7) (31.3) with 23 (24.0) 6-9 mm 12 (12.5) adenomas 10 < (10.4) mm 3 (3.1) 10 mm 24 (25.0) 22 (22.9) 3 (3.1) 19

20 The unique offering of Methylene Blue MMX No loss of time by endoscopist Tablets taken pre colonoscopy Patients come to the endoscopist with fully dyed colon MMX is the only way of making cellular structures visible In chromoendoscopy only the intracellular space is dyed since methylene blue absorption takes longer HD and NBI cannot depict cellular structures Homogenous and reliable stain of the entire colon Traditional chromoendoscopy is subjective Highest likelihood of detection of polyps and adenomas Detection allows immediate excision Less discomfort for patient Substantial cost savings for patient Allows first in class colon cancer prevention also in regional hospitals and private practice and will thus contribute to substantially reducing the incidence of colon cancer 20

21 Methylene Blue MMX, the transformational business case Very large and continuously growing market Recommendations that all persons over 50 have a colonoscopy every 5-10 years Business Case In the 7 major markets this would mean ~ 55 m colonoscopies, in the whole industrialized world ~ 200 m colonoscopies per year In m colonoscopies are projected in 7 major markets The world wide population is ageing quickly; this increases market potential Best method to depict cellular structures Will substantially improve the cost per polyp and adenoma detected and excised 81% more polyps and 49% more adenomas found than with white light colonoscopy Lowest cost of colonoscopy in EU is in Italy with EUR 510 Can be applied world wide Not a competition to HD scopes and filters Delivery of all stains and dyes by tablets to the colon patented by Cosmo 21

22 Methylene Blue MMX ; next steps In EU EMA has authorized centralized procedure In USA an IND will be submitted before year end Phase III to start Q1 13 ~1500 Patients between CRC diagnosis and longstanding UC KOLs involved as PI in the main US and EU sites 3 CROs to be selected with specific tasks Total cost:~ EUR 10 m Data report: end 2013 Partner will be sought to support regulatory process 22

23 Cosmo Pharmaceuticals Information Number of shares: 14,995,743 Listing: SIX Swiss exchange, Main board ISIN: IT Contacts Mauro Ajani, CEO Chris Tanner, CFO ph: Giuseppe Cipriano, COO Luigi Moro, CSO 23