Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — FY2017 Earnings Presentation
46 slides from Cosmo Pharmaceuticals Nv's earnings presentation, Mar 26, 2018
Slide 1: Full Year Report 2017
Full Year Report 2017 Zurich, 26 March 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 2017 Key Events Alessandro Della Chà, CEO 2017 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
Slide 4: Key Events - 2017: Eleview and Methylene Blue MMX
Key Events - 2017: Eleview and Methylene Blue MMX Started to build up our US sales and marketing organization putting in place the resources to commercialize our products in the US Announced the successful clinical trial of Eleview against standard of care in endoscopic mucosal resection of large se
Slide 5: Key Events - 2017: Rifamycin SV MMX
Key Events - 2017: Rifamycin SV MMX Rifamycin SV MMX granted both QIPD and Fast Track designations by the FDA. NDA filed 19 March 2018 NDA approval expected in second half of 2018, expected launch in the US in Q1 2019 Dr. Falk Pharma, our licensee for Europe and selected countries excluding the US,
Slide 6: Key Events - 2017: Remimazolam
Key Events - 2017: Remimazolam Remimazolam successfully concluded its US Phase III clinical trial in procedural sedation in patients undergoing bronchoscopy and in patients with III/IV ASA conditions, meeting the primary endpoint and paving the way for approval filing NDA filing expected 4Q 2018/1Q
Slide 7: Key Events - 2017: Lialda
Key Events - 2017: Lialda In the US, generic entry in June 2017, decrease of revenues in 2017 of €282k In EU and RoW, increase of revenues of €2,910k In Japan, increase of revenues of €443k Expected ramp up in Japan + €2,432 (including royalties) and EU and RoW + €960k will partially compensate lost
Slide 8: Key Events - 2017: Uceris & Cortiment
Key Events - 2017: Uceris & Cortiment UCERIS Net sales US$134.2m vs US$155.3m in 2016 Royalty and manufacturing income in 2017 €25.7m vs €31.9m in 2016 Filed for arbitration against Valeant seeking termination of license agreement, award expected soon Cortiment Sales by Ferring increased 38% and a f
Slide 9: Key Events - Q1 2018: Business activities
Key Events - Q1 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, Rif
Slide 10: 2017 Financial Review
2017 Financial Review 10
Slide 11: 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 12: 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 13: 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 14: 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 15: 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 16: 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% G
Slide 17: Income Statement – Revenue (Eleview sales)
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 17
Slide 18: 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 19: 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 20: Statement of financial position
Financial Review: Statement of financial position Cash and bonds €247.2m – 49.6% of total assets Investment in associate Cassiopea €135.7m Other current assets €24.6m, includes inventory, trade receivables and tax assets Total Assets €498.0m Total liabilities €27.9m Equity €470.1m 20
Slide 21: Statement of financial position: other non-current assets
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 22: Statement of financial position: intangible assets
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 23: Statement of financial position: cash and financial assets
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 24: Products and R&D Update
Products and R&D Update 24
Slide 25: Methylene Blue MMX
Methylene Blue MMX NDA accepted by the FDA PDUFA date 21 May 2018 Pre-commercialization activity underway Launch expected in H2 2018 25
Slide 26: Rifamycin SV MMX
Rifamycin SV MMX NDA filed March 19 2018 Expected approval Q4 2018; pre-commercialization activity in US underway with launch expected in H1 2019 FDA granted both Qualified Infectious Disease Product (QIDP) and Fast Track designation for Rifamycin SV for the treatment of patients with travelers’ dia
Slide 27: 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 28: Remimazolam
Remimazolam Successfully completed phase III trials in 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 expiring 2033
Slide 29: 2018 Outlook and Forecast
2018 Outlook and Forecast 29
Slide 30: 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 31: Eleview – US market opportunity
Eleview – US market opportunity Launched at DDW in May 2017 Units May to December 2017: 5,323 January 2018: 1,586 units + 18.5% month over month compared to December 2017 February 2018: 1,650 units + 4.0% month over month compared to January 2018 March 2018: Forecast 2,000 units + 21.2% month over m
Slide 32: Eleview net sales May 2017 to March 2018 US$3.8M
Eleview net sales May 2017 to March 2018 US$3.8M 32
Slide 33: 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 Forecast sales force expansion for MB will result in 25% increased resources promoting Eleview in second half of 2018 Eleview sales forecast
Slide 34: MB MMX – US Market Opportunity
MB MMX – US Market Opportunity 16m US colonoscopies annually, 74% colorectal cancer related 12m US colorectal cancer related colonoscopies 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 s
Slide 35: MB MMX – Derived value propositions from market research
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 36: 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 37: 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 1/3rd 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 accep
Slide 38: 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 39: 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 40: 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 41: 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 42: 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 Pre-commercialization activity for Methyle
Slide 43: 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 43
Slide 44: Key Priorities and Upcoming Milestones 2018
Key Priorities and Upcoming Milestones 2018 Obtain FDA approval for Methylene Blue MMX PDUFA date 21 May 2018 Launch Methylene Blue MMX in H2 once approved Progress Rifamycin SV MMX NDA Progress Rifamycin SV MMX IBS-D Phase II trial File Remimazolam NDA Partner pipeline in RoW Read-out of Cassiopea
Slide 45: 2018 Cosmo Overall Guidance
2018 Cosmo Overall Guidance €'000 FY 2018 FY 2018 Case a) Case b) Traditional contract manufacturing and other revenue 9 9 Products manufacturing 29 29 Royalties 18 18 Licence fees, up-front fees and milestones 10 10 Aries U.S. sales 18 28 Total Revenues 84 94 Total Operating Expenses* (125) (125) *
Slide 46: Contact
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 46