Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Jefferies 2018 Healthcare Conference
44 slides from Cosmo Pharmaceuticals Nv's conference presentation, Jun 5, 2018
Slide 1: Jefferies 2018 Healthcare Conference
Jefferies 2018 Healthcare Conference New York, 5 June 2018
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: Agenda
Agenda Introduction and ytd 2018 Key Events 2017 Financial Review Products and R&D Update 2018 Outlook & Forecast Questions & Answers 3
Slide 4: Key Events - YTD 2018: Business activities
Key Events - YTD 2018: Business activities Expanded exclusive distribution agreement for Eleview with FUJIFILM Europe B.V. beyond Europe and South Africa to South East Asia, Middle East, Africa, Australia and New Zealand Entered into a license and supply agreement for Eleview, Methylene Blue MMX, Ri
Slide 5: Key Events - YTD 2018: Business activities
Key Events - YTD 2018: Business activities Unfavourable award of Arbitral Tribunal in respect of request to terminate Uceris License Agreement with Valeant Cosmo Pharmaceuticals receives Complete Response Letter from the FDA on Methylene Blue MMX NDA FDA accepts new drug application submission for C
Slide 6: Financial Review 2017: Highlights
Financial Review 2017: Highlights Revenue €67.2m vs €67.7m in 2016 Operating costs of €76.8m, up €33.8m vs 2016 mainly as a result of establishment of marketing and sales organization in US and launch of Eleview Loss as share of Cassiopea’s result: €5.9m vs. €3.6m in 2016 Operating loss: €15.5m vs.
Slide 7: Financial Review 2017: Highlights
Financial Review 2017: Highlights Change in equity of €54.6m primarily as a result of: − Capital increase of €96.2m as a result of the issue of shares related to the exercise of ESOP vested options and sale of treasury shares − Dividend payment €22.6m − Loss after tax €32.4m Cash and bonds of €247.2
Slide 8: Financial Review: Income Statement
Financial Review: Income Statement €'000 FY 2017 FY 2016 FY Change Revenue 67,242 67,664 (422) Other Income 470 730 (260) Cost of sales (21,988) (19,851) (2,137) Research and development costs (9,049) (8,257) (792) Selling, general and administrative costs (46,279) (15,659) (30,620) Net Operating ex
Slide 9: Financial Review: Income Statement
Financial Review: Income Statement Revenue €67.2m v €67.7m in prior year − Eleview income of €1.6m, Cortiment income up €2.0m (inc. milestone €1m), Lialda income up €3.5m − Uceris income down €6.2m, Generic manufacturing income and other down €1.3m COGS increase of €2.1m due to different mix of prod
Slide 10: Financial Review: Income Statement – Revenue
Financial Review: Income Statement – Revenue €'000 - (Unless otherwise stated) FY 2017 FY 2016 % Change UCERIS Net Sales - US$ $134,170 $155,278 -14% Manufacturing Income 11,644 14,127 -18% Royalty Income 14,078 17,767 -21% Total Income 25,722 31,894 -19% Cortiment Net Sales 13,476 9,771 38% Milesto
Slide 11: Financial Review: Income Statement – Revenue
Financial Review: Income Statement – Revenue €'000 FY 2017 FY 2016 % Change Lialda/ Mezavant/ Mesavancol Manufacturing Income 24,050 21,197 13% Royalty Income 1,168 503 132% Total Income 25,218 21,700 16% Generic & Other Manufacturing & Other Income 10,322 11,609 -11% Total Income 10,322 11,609 -11%
Slide 12: Financial Review: Income Statement – Revenue
Financial Review: Income Statement – Revenue €'000 FY 2017 Eleview sales Units 5,323 Net Sales 1,568 Launched in May 2017 Sales growing as planned, more than 1,000 accounts opened so far Each unit contains 5 vials 12
Slide 13: Financial Review: Income Statement – Net Result
Financial Review: Income Statement – Net Result Net operating expenses €76.8m up €33.8m mainly due to increase in SG&A costs due to significant investment in US marketing and sales organization Share of result of Cassiopea: loss of €5.9m Net financial expenses €16.9m largely related to movement in E
Slide 14: Financial Review: Statement of financial position
Financial Review: Statement of financial position €'000 FY 2017 FY 2016 FY Change Non current financial assets 93,811 71,984 21,827 Investment in associates 135,742 141,511 -5,769 Other non current assets 71,115 42,905 28,210 Cash and cash equivalents 144,944 117,649 27,295 Current financial assets
Slide 15: Financial Review: Statement of financial position
Financial Review: Statement of financial position Cash and bonds as of December 31 € 247.2m – 49.6% of total assets Cash as of May 31 € 239m Investment in associate Cassiopea €135.7m Other current assets €24.6m, includes inventory, trade receivables and tax assets Total Assets €498.0m Total liabilit
Slide 16: Financial Review: Statement of financial position
Financial Review: Statement of financial position €'000 Other non-current assets FY 2017 FY 2016 FY Change Property, plant and equipment 30,152 20,672 9,480 Goodwill 109 109 - Other intangible assets 28,525 19,546 8,979 Deferred tax assets 10,456 2,578 7,878 Other non-current receivables 1,873 - 1,8
Slide 17: Financial Review: Statement of financial position
Financial Review: Statement of financial position €'000 Intangible Assets FY 2017 FY 2016 FY Change - Methylene Blue MMX 9,464 4,189 5,275 - Aemcolo 3,197 1,050 2,147 - Eleview 1,607 523 1,084 - Remimazolam 437 - 437 Capitalised Development Costs 14,705 5,762 8,943 Remimazolam license 10,000 10,000
Slide 18: Financial Review: Statement of financial position
Financial Review: Statement of financial position €'000 - Cash & Financial Assets FY 2017 FY 2016 FY Change Bonds 102,217 101,517 700 Investments 19,352 19,303 49 Total non-current & current financial assets 121,569 120,820 749 0 Cash 144,944 117,649 27,295 • The increase in property plant and equip
Slide 19: Products and R&D Update
Products and R&D Update 19
Slide 20: Methylene Blue MMX
Methylene Blue MMX Complete Response Letter Received 22 May 2018 We are engaging with the FDA to address issues raised in the CRL 20
Slide 21: Methylene Blue MMX addresses:
Methylene Blue MMX addresses: 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 US In 2014 the NCI estimated that more than 50,000 persons died in the US from CRC Experts estimate that at least 95% of CRC cases arise from pre
Slide 22: Methylene Blue MMX increases: Adenoma Detection Rate
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 For each 1% increase in ADR, the risk of an Interval Cancer (
Slide 23: Methylene Blue MMX increases: Adenoma Detection Rate
Methylene Blue MMX increases: Adenoma Detection Rate ADR HDWL 47.81% versus MB MMX 200 mg 56.29%, p-value 0.0027, 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, in a d
Slide 24: Rifamycin SV MMX
Rifamycin SV MMX FDA has accepted our new drug application submission for Rifamycin SV MMX and has set the PDUFA date of November 16, 2018 with accelerated review Mid-cycle review meeting scheduled for June 26, proposed labelling scheduled for August 23, Expected approval Q4 2018; pre-commercializat
Slide 25: Rifamycin SV MMX
Rifamycin SV MMX IBS-D phase II trial started October 17, 25 sites, 342 patients, first patient randomized December 2017, trial end expected by end of 2018. Estimated 8 yrs of regulatory exclusivity as a New Molecular Entity (NME – 3 yrs) and under the QIDP for the additional IBS-D indication combin
Slide 26: Remimazolam
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 the Q42018/1Q2019 Five years regulatory exclusivity as NCE Six patents granted, last e
Slide 27: 2018 Outlook and Forecast
2018 Outlook and Forecast 27
Slide 28: Eleview – US market opportunity
Eleview – US market opportunity 16m US colonoscopies annually 2.4 average polyp/patient as found in MB 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$81 per vial Market O
Slide 29: Eleview – US market opportunity
Eleview – US market opportunity Launched at DDW in May 2017 ELEVIEW - Monthly Units 1.984 1.958 200 0 Units May to December 2017: 5,323 180 0 1.650 1.731 1.586 160 0 140 0 1.338 January 2018: 1,586 units + 18.5% month 1.287 over month compared to December 2017 120 0 1.021 100 0 800 692 February 2018
Slide 30: Eleview net sales May 2017 to May 2018 US$ 4.8M
Eleview net sales May 2017 to May 2018 US$ 4.8M ELEVIEW - Cum ulative Sales US$ 4.757.522 5.0 00. 000 4.5 00. 000 4.186.517 4.0 00. 000 3.684.073 3.5 00. 000 3.121.966 3.0 00. 000 2.545.451 2.5 00. 000 1.770.310 2.0 00. 000 1.383.851 1.5 00. 000 979.543 1.0 00. 000 645.585 377.298 500. 000 155.681 9
Slide 31: Eleview
Eleview Agreement signed with FUJIFILM for distribution in Europe and South Africa and also to South East Asia, Middle East, Africa, Australia and New Zealand Eleview sales forecast 2018: USD 12m 31
Slide 32: MB MMX – US Market Opportunity
MB 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 32
Slide 33: MB MMX – Derived value propositions from multiple market research studies
MB MMX – Derived value propositions from multiple market research studies Physicians are most likely to classify MB MMX as The Payor value is centered on improving clinical a "visualization and detection aid" that outcomes and quality measures ADR is a top priority with an inverse correlation with i
Slide 34: Rifamycin SV MMX – US market opportunity
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 pr
Slide 35: Rifamycin SV MMX – US market opportunity
Rifamycin SV MMX – US market opportunity Based on a survey of 200+ physicians, they would prescribe Rifamycin SV MMX in at least 1/3 rd 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 acce
Slide 36: Rifamycin SV MMX – US market opportunity
Rifamycin SV MMX – US market opportunity Payors Landscape - Unmet Need: 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
Slide 37: Remimazolam – US Market Opportunity
Remimazolam – US Market Opportunity Remimazolam 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
Slide 38: Remimazolam – US Market Opportunity
Remimazolam – US Market Opportunity Remimazolam 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 sedatio
Slide 39: Remimazolam – US Market Opportunity
Remimazolam – US Market Opportunity Remimazolam 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
Slide 40: Aries
Aries 91-person organization in place as at December 2017 67 marketing and sales 12 MSL and Scientific Affairs 12 Management and Administration Eleview launched at DDW in May 2017 and co-promotion agreement with Olympus Americas Inc. adding 200 salespersons We do not expect MB MMX guidance for 2018
Slide 41: US Opportunity Summary
US Opportunity Summary Estimated peak sales US: 7 - 8 years after launch Eleview US$65m - $75m Methylene Blue MMX US$600m - $700m Rifamycin SV MMX US$200m - $250m Remimazolam procedural sedation: US$150m - $200m 41
Slide 42: Key Priorities and Upcoming Milestones 2018
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 Read-out of Cassiopea Winlevi phase III pivotal study Read-out of Cassiopea Br
Slide 43: 2018 Cosmo Overall Guidance
2018 Cosmo Overall Guidance €'000 FY 2018 Traditional contract manufacturing and other revenue 9 Products manufacturing 29 Royalties 18 Licence fees, up-front fees and milestones 10 Aries U.S. sales 10 Total Revenues 76 Total Operating Expenses* -107 * Of which investment in Aries -42 Total EBITDA*
Slide 44: Cosmo Pharmaceuticals NV contact details
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 +353 1 817 03 70 44
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