Half Year Dublin, 26 July 2018

Transcription

1 Half Year 2018 Dublin, 26 July 2018

2 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 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 commercialization 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 forwardlooking 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 its products. 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. 2

3 Agenda Introduction and ytd 2018 Key Events Alessandro Della Chà, CEO 2018 Half Year Financial Review Niall Donnelly, CFO Products and R&D Update Alessandro Della Chà, CEO 2018 Outlook & Forecast Alessandro Della Chà, CEO Questions & Answers All 3

4 Introduction and H Key Events Alessandro Della Chà, CEO

5 Key Events H Complete response letter received from FDA in relation to Methylene Blue MMX NDA. NDA not approved in current form. Type A meeting held with FDA on 25 July 2018, the outcome will be communicated once available. Rifamycin SV MMX New Drug Application seeking marketing authorisation for the treatment of Traveler s Diarrhea accepted by the FDA. PDUFA date of 16 November set by FDA to complete their review. Rifamycin SV MMX Phase II proof of concept study in IBS-D progressed. Eleview gross sales in the U.S. $4.6m vs $2.1m in H License and supply agreement entered into with Pharmascience for Eleview, Methylene Blue MMX, Rifamycin SV MMX and Qolotag for the territory of Canada. 5

6 Key Events H Eleview agreement with FUJIFILM Europe B.V. expanded to South East Asia, Middle East, Africa, Australia and New Zealand, Cosmo to receive 45% of gross revenues. License and supply agreement entered into with EA Pharma for Methylene Blue MMX and Eleview for the territories of Japan and South Korea. Our associate Cassiopea SpA, of which we own 45.09%, communicated a sequence of very good news including the successful Phase III clinical trial outcome of its drug Winlevi for the treatment of acne. As at the 24th of July, Cosmo s stake in Cassiopea has a market value of million compared to million as at 31 December ICC Tribunal ruled that Valeant was not in breach of the Uceris License Agreement. 6

7 H Financial Review Niall Donnelly, CFO

8 H1 FY18 Financial Highlights Revenue up 15.2% to 36.7m driven by up-front license fees Operating costs up 21.4% to 43.9m mainly due to build up of our U.S. organisation Operating loss 7.2m vs 4.3m last year Net finance income 4.8m related to /US$ FX rate movement Loss for the period 7.8m (including share of Cassiopea loss 2.9m) Cash and investments 230.2m vs 247.1m at FY17 YE Total assets 479.6m vs 498.0m at FY17 YE Equity 456.4m vs 470.1m at FY17 YE 8

9 Income Statement EUR 000 H H Change Revenue 36,660 31,824 4,836 Other income (28) Cost of sales (10,714) (10,670) (44) Research and development costs (4,459) (4,557) 98 Selling, general and administration (28,938) (21,184) (7,754) Net Operating Expenses (43,871) (36,143) (7,728) Operating (Loss) / Profit (7,211) (4,319) (2,892) Net finance income / (expenses) 4,823 (11,000) 15,823 Share of result of associates (2,895) (4,049) 1,154 (Loss) / Profit before taxes (5,283) (19,368) 14,085 Income tax expenses (2,506) 2,098 (4,604) (Loss) / Profit for the period (7,789) (17,270) (9,481) 9

10 Income Statement - Revenue EUR 000 H H % Change Uceris Net Sales US$ US$ 69,726 US$ 62, % Manufacturing Income 5,936 5, % Royalty Income 7,110 6, % Total Income 13,046 12, % Cortiment Net Sales 7,248 6, % Manufacturing Income % Royalty Income 1,521 1, % Total Income 1,824 1, % 10

11 Income Statement - Revenue EUR 000 H H Change Lialda/Mezavant/Mesavancol Manufacturing Income 9,660 12,267 (2,607) Royalty Income Total Income 10,589 12,745 (2,156) Generic of Lialda approved during 2017, current TRx of branded and Authorised Generic at 50% of branded TRx pre launch of generic. Decline in U.S. partially offset by increase in income in Japan and Europe Eur 000 H H Change License fees, up-front fees & milestones & Generic & Other License fees, up-front fees and milestones 3, ,205 Generic & Other 4,735 4,957 (222) Total Income 8,440 5,457 2,983 11

12 Income Statement - Revenue EUR 000 H H Change Eleview Units 10, ,557 Net Income 2, ,729 In H1 FY18 10,656 units shipped to end users compared with 5,224 units in H2 FY17 Gross sales US$4.6m in H1 FY18 compared to US$2.1m in H2 FY17 Each unit contains 5 vials 12

13 Income Statement Operating costs of 43.9m vs 36.1m in same period last year o Increase in operating costs mainly due to build up of U.S. marketing and sales organisation which is now generating sales and preparing for the launch of Rifamycin SV MMX in H1 FY19 subject to regulatory approval Net finance income 4.8m vs net financial expenses 11.0m in H o Movement largely relates to net FX gains of 3.5m due to the strengthening of the US$ against the Euro in H1 compared to net FX losses in the prior year of 11.5m Loss of share of Cassiopea s result 2.9m vs 4.0m in H

14 Statement of financial position EUR Jun Dec 17 Change Non current financial assets 58,620 93,811 (35,191) Investment in associates 132, ,742 (2,844) Other non current assets 71,675 71, Cash and cash equivalents 84, ,944 (60,601) Current financial assets 102,758 27,759 74,999 Other current assets 29,294 24,603 4,691 Total assets 479, ,974 (18,386) Medium to long term interest bearing loans and borrowings 3,630 3,827 (197) Other non-current liabilities 4,899 4, Short-term interest bearing loans (15) Other current liabilities 14,057 18,783 (4,726) Equity attributable to owners of the company 456, ,117 (13,749) Total equity and liabilities 479, ,974 (18,386) 14

15 Statement of financial position EUR 000 Cash & Financial Assets 30 Jun Dec 17 Change Bonds & investments in funds 145, ,218 43,682 Equity Investments 15,478 19,352 (3,874) Total non-current & current financial assets 161, ,570 39,808 Cash 84, ,944 (60,601) Total cash, non-current & current financial assets 245, ,514 (20,793) Cash, bonds & investments in funds 230, ,162 (16,919) % US$ denominated investments and cash 30.7% 47.1% 15

16 Statement of financial position Investment in associate Cassiopea 132.9m o Market value of Cosmo 45.09% stake as at 24 July 193.5m as a result of share price increase following successful Phase III Winlevi clinical trial Other current assets 29.2m, includes inventory, trade receivables and tax assets 000 Other current assets 30 Jun Dec 17 Change Inventories 3,947 3, Trade receivables 16,200 13,190 3,010 Current tax assets 4,065 2,972 1,093 Other receivables and other assets 5,082 5,200 (118) Total other current assets 29,294 24,603 4,691 16

17 Statement of financial position 000 Other non-current assets 30 Jun Dec 17 Change Property, plant and equipment 29,497 30,152 (655) Goodwill Other intangible assets 31,325 28,525 2,800 Deferred tax assets 8,638 10,456 (1,818) Other non-current receivables 2,106 1, Total other non-current assets 71,675 71,

18 Statement of financial position 000 Intangible Assets 30 Jun Dec 17 Change - Methylene Blue MMX 8,424 9,464 (1,040) - Rifamycin SV MMX 6,586 3,197 3,389 - Eleview 1,560 1,607 (47) - Remimazolam Capitalised Development Costs 17,495 14,705 2,790 Remimazolam license 10,000 10,000 - Patents & Rights 3,830 3, Total Intangible Assets 31,325 28,525 2,800 18

19 Statement of financial position Total Assets 479.6m Total liabilities 23.2m Equity 456.4m 19

20 Products and R&D Update Alessandro Della Chà, CEO

21 Methylene Blue MMX Complete Response Letter received 22 May 2018 NDA not approved in current form Type A meeting request and briefing document submitted to FDA in June Type A meeting took place on 25 July and outcome will be communicated once available 21

22 Methylene Blue MMX CRC is reported to be the third most common cancer and the third cause of deaths within cancers in both women and men in the U.S. In 2014 the NCI estimated that more than 50,000 people died in the U.S. from CRC Experts estimate that at least 95% of CRC cases arise from pre-existing adenomas As of today, the adenoma-carcinoma sequence is not disputed as the most accredited CRC developing route Adenomas are randomly distributed in patients and within patients present in different numbers. Their presence and/or number are not predictable and the prevalence of adenomas in average risk screening population ranged from 22% to 58% ASGE and ESGE recommend removing all lesions found during colonoscopy as a prevention measure 22

23 Methylene Blue MMX increases Adenoma Detection Rate The adenoma detection rate (ADR) is the percentage of patients aged 50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected and removed ADR is a key colonoscopy quality measure For each 1% increase in ADR, the risk of an Interval Cancer (IC) decreases by 3% and the CRC mortality risk decreases by 5% In patients where at least one adenoma is found, the patient will go under an accelerated surveillance program, depending on type and number of adenomas There is a clear and well-established connection between ADR and IC occurrence and mortality, so that an increase in ADR represents a clear and quantitative improvement in CRC prevention 23

24 Methylene Blue MMX increases Adenoma Detection Rate ADR HDWL 47.81% versus Methylene Blue MMX 200 mg 56.29%, p-value , relative risk increase 17.7%, Odds ratio 1.41 (1.09, 1.81) An absolute gain in ADR (including carcinomas) of 8.3% translates, according to the results published by Corley in 2014, to a decrease of IC of > 24% and, more importantly, a lower mortality for CRC of > 40% We believe that the concerns raised by the FDA are fully addressable We will continue to pursue regulatory approval for the product 24

25 Rifamycin SV MMX FDA has accepted our NDA submission for Rifamycin SV MMX and has set the PDUFA date of November 16, 2018 with accelerated review Pre-commercialization activity in U.S. underway, launch expected in H subject to regulatory approval FDA granted both Qualified Infectious Disease Product (QIDP) and Fast Track designation for Rifamycin SV MMX for the treatment of patients with Traveler s Diarrhea 10 yrs of regulatory exclusivity 25

26 Rifamycin SV MMX Dr. Falk Pharma has filed for marketing authorization of Rifafalk 200mg (Rifamycin SV MMX tablets) in Germany as Reference Member State through a de-centralized procedure. Response expected by the end Q IBS-D phase II trial started October 17, 25 sites, 342 patients, first patient randomized December 2017, trial end expected by end of Estimated 8 yrs of regulatory exclusivity as a New Molecular Entity (NME 3 yrs) and under the QIDP for the additional IBS-D indication combined (5 yrs) Improved safety profile compared to ciprofloxacin: Rifamycin SV MMX has no systemic absorption (very important for resistance) and no warning box issues 26

27 Rifamycin SV MMX Compared to competitors, Rifamycin SV MMX allows antibiotic to be delivered directly to the colon, avoiding unwanted effects on the beneficial saprophytic bacterial flora living in the upper portions of the gastrointestinal tract Rifamycin SV MMX enjoys significantly more potent anti-inflammatory properties and lower likelihood to develop resistance 27

28 Remimazolam Successfully completed phase III trials in colonoscopy, bronchoscopy and II/IV ASA patients. These trials conclude the set of trials required for procedural sedation registration NDA filing expected by end Q Five years regulatory exclusivity as NCE Six patents granted, last expiring

29 2018 Outlook & Forecast Alessandro Della Chà, CEO

30 Eleview US Market opportunity 16m US colonoscopies annually 2.4 average polyp/patient as found in Methylene Blue MMX trial: total 38.4 million lesions 8% of polyps required injection: total injection approx. 3 million Average 1.5 vial per removal: total 4.5 million vials Current price: US$81 per vial Market Opportunity approx. US$350m Estimated peak sales US$65m - $75m (20% of the market) Time line to peak sales 7-8 years 30

31 Eleview Launched at DDW in May 17 Units Jul 17 to Dec 17: 5,224 Units Jan 18 to Jun 18: 10,656 Cumulative net sales to Jun 18 since launch: US$ 5.1m FY18 U.S. sales forecast US$12m 31

32 Eleview Agreement with FUJIFILM expanded beyond Europe and South Africa to South East Asia, Middle East, Africa, Australia and New Zealand FUJIFILM planning market launch in second half 2018 Cosmo will receive 45% of gross revenues U.S. FY18 sales forecast US$12m 32

33 Methylene Blue MMX US Market Opportunity 16m US colonoscopies annually 31% colonoscopies in IBD patients/high risk patients Estimated market opportunity US$3 billion Estimated peak sales US $600m - $700m Estimated time line to peak sales 7-8 years 33

34 Methylene Blue MMX US Market Opportunity Physican Patient Payor Methylene Blue MMX significantly improves Adenoma Detection Rate (ADR) a key colonscopy quality indicator A 1% increase in ADR results in a 3% decrease in the risk of interval CRC and a 5% decease in mortality risk 81% of respondents patient would proactively speak to their Doctor about Methylene Blue MMX 68% would recommend Methylene Blue MMX to others 87% would take it if recommended by GI N=30 Value is centered on improving clinical outcomes and quality measures Improves quality: Significantly improves colonoscopy quality with 17.7% increase in ADR Improves detection of flat and small lesions that are most often missed and contribute to interval cancers Economic: Does not increase colonoscopy procedure time Compared to direct colonoscopy cost, Methylene Blue MMX is relatively inexpensive 34

35 Rifamycin SV MMX US Market Opportunity Sales of Xifaxan US$1 billion Estimated Market Opportunity US$1 billion 20-25% market share Estimated peak sales US$200m - $250m Estimated time line to peak sales 7-8 years Rifamycin sales forecast 2019: US$11m gross Physicians perceive advantages in the product over competitors Lower likelihood of developing resistance, efficacy in C-diff Price is a potential lever 35

36 Rifamycin SV MMX US Market Opportunity Based on a survey of 200+ physicians, they would prescribe Rifamycin SV MMX in at least 1/3rd of the cases where they prescribe branded competitors assuming similar price Based on a survey of 15 payors covering over 100m US lives, payors believe that an acceptable price for Rifamycin SV MMX is close to that of Xifaxan, the only branded treatment for Traveler s Diarrhea 36 Source: Aries Physician and Payer Market Research, March 2018

37 US Market Opportunity Payors Landscape - Unmet Need: Physician Perceptions of Rifamycin: Payors are generally satisfied with current treatments but note that some treatments have limitations Payors report a level of unmet need of 3.3/7 Key unmet needs noted are: Bacterial resistance, C. Diff. infections Payors would welcome new agents to treat GI infections. They see no reason not to cover, other than the product being priced higher than its overall value to the market Sampled physicians consider Rifamycin SV MMX to perform slightly better across all product attributes Performance scores of /7 for all attributes Sampled physicians believe that Rifamycin SV MMX perform moderately better than the SoC (5.2/7) Clinical cure rate as well as general safety/tolerability were noted as the primary positive attributes for Rifamycin SV MMX this mirrors favorably to their stated prescribing decision-making Non-systemic absorption is also stated as a key product attribute There is little difference in product perception between gastroenterologists and internal medicine physicians 37

38 Remimazolam US Market Opportunity Sedative selection is highly correlated with monitored anesthesia care (MAC) utilization In general, physicians are moderately satisfied with available sedative options Onset of action, breakthrough discomfort, and delayed recovery were the most cited areas of concern for Midazolam Hypotension was mentioned as a concern for Propofol Reaction to the product concept was favorable with an average enthusiasm score of 7.5 (scale of 1-10) Potential for faster patient throughput, shorter half-life, safety, and speed of onset were cited as the most valuable attributes of the product 38

39 Remimazolam US Market Opportunity Physicians indicated that Remimazolam will most likely be considered as a replacement for midazolam in routine procedures dependent on price and value Based on the primary research feedback, no significant changes to the forecast for procedural sedation Midazolam share capture of 30-45% and eventual Propofol share capture depending on overall perception of the benefits of Remimazolam once on the market Pricing assumed at US$30/procedure (average 24mg used, or US$1.25/mg), pending updates from the reimbursement assessment work 39

40 Remimazolam US Market Opportunity 24.5m annual US colonoscopies, upper GI endoscopies and bronchoscopies 90% of US colonoscopies, upper GI endoscopies and bronchoscopies that used Moderate Sedation Estimated market opportunity in procedural sedation US$600m Estimated peak sales US$150m $200m Estimated timeline to peak sales: 5-7 years 40

41 41

42 US Market Opportunity 85-person organization in place as at June marketing and sales 10 MSL and Scientific Affairs 14 Management and Administration Eleview launched at DDW in May 2017 and co-promotion agreement with Olympus Americas Inc. in October 2017 which added 200 salespersons We do not expect guidance for 2018 to change, while there may not be Methylene Blue MMX revenues in this year, there also won t be the associated product launch and sales force costs Expected Opex 2018: US$50m Expected revenues: US$12m 42

43 US Market Opportunity Estimated peak sales US: 7-8 years after launch Eleview Methylene Blue MMX Rifamycin SV MMX Remimazolam procedural sedation: US$65m - $75m US$600m - $700m US$200m - $250m US$150m - $200m 43

44 Key Priorities and Upcoming Milestones 2018 Address issues with FDA re Methylene Blue MMX Rifamycin SV MMX PDUFA 16 November 2018 Progress Rifamycin SV MMX IBS-D Phase II trial File Remimazolam NDA Partner pipeline in RoW 44

45 Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson s Quay Dublin 2, Ireland media@cosmopharma.com Mr. Alessandro Della Cha, CEO adellacha@cosmopharma.com Mr. John Manieri, IR jmanieri@cosmopharma.com