Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — H1 2018 Earnings Presentation
45 slides from Cosmo Pharmaceuticals Nv's earnings presentation, Jul 26, 2018
Slide 1: Half Year 2018
Half Year 2018 Dublin, 26 July 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 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
Slide 4: Introduction and H1 2018 Key Events
Introduction and H1 2018 Key Events Alessandro Della Chà, CEO
Slide 5: Key Events H1 2018
Key Events H1 2018 ➢ 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 authorisat
Slide 6: Key Events H1 2018
Key Events H1 2018 ➢ 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 J
Slide 7: H1 2018 Financial Review
H1 2018 Financial Review Niall Donnelly, CFO
Slide 8: H1 FY18 Financial Highlights
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
Slide 9: Income Statement
Income Statement EUR ‘000 H1 2018 H1 2017 Change Revenue 36,660 31,824 4,836 Other income 240 268 (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)
Slide 10: Income Statement - Revenue
Income Statement - Revenue EUR ‘000 H1 2018 H1 2017 % Change Uceris Net Sales – US$ US$ 69,726 US$ 62,850 10.9% Manufacturing Income 5,936 5,584 6.3% Royalty Income 7,110 6,564 8.3% Total Income 13,046 12,148 7.4% Cortiment Net Sales 7,248 6,341 14.3% Manufacturing Income 303 242 25.2% Royalty Incom
Slide 11: Income Statement - Revenue
Income Statement - Revenue EUR ‘000 H1 2018 H1 2017 Change Lialda/Mezavant/Mesavancol Manufacturing Income 9,660 12,267 (2,607) Royalty Income 929 478 451 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
Slide 12: Income Statement - Revenue
Income Statement - Revenue EUR ‘000 H1 2018 H1 2017 Change Eleview Units 10,656 99 10,557 Net Income 2,761 32 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
Slide 13: Income Statement
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
Slide 14: Statement of financial position
Statement of financial position EUR ’000 30 Jun 18 31 Dec 17 Change Non current financial assets 58,620 93,811 (35,191) Investment in associates 132,898 135,742 (2,844) Other non current assets 71,675 71,115 560 Cash and cash equivalents 84,343 144,944 (60,601) Current financial assets 102,758 27,75
Slide 15: Statement of financial position
Statement of financial position EUR ’000 Cash & Financial Assets 30 Jun 18 31 Dec 17 Change Bonds & investments in funds 145,900 102,218 43,682 Equity Investments 15,478 19,352 (3,874) Total non-current & current financial assets 161,378 121,570 39,808 Cash 84,343 144,944 (60,601) Total cash, non-cu
Slide 16: Statement of financial position
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 ta
Slide 17: Statement of financial position
Statement of financial position € ’000 Other non-current assets 30 Jun 18 31 Dec 17 Change Property, plant and equipment 29,497 30,152 (655) Goodwill 109 109 - Other intangible assets 31,325 28,525 2,800 Deferred tax assets 8,638 10,456 (1,818) Other non-current receivables 2,106 1,873 233 Total oth
Slide 18: Statement of financial position
Statement of financial position € ’000 Intangible Assets 30 Jun 18 31 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 925 437 488 Capitalised Development Costs 17,495 14,705 2,790 Remimazolam license 10,000 10,000 -
Slide 19: Statement of financial position
Statement of financial position Total Assets Total liabilities Equity €479.6m €23.2m €456.4m 19
Slide 20: Products and R&D Update
Products and R&D Update Alessandro Della Chà, CEO
Slide 21: Methylene Blue MMX
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
Slide 22: Methylene Blue MMX
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-e
Slide 23: Methylene Blue MMX increases Adenoma Detection Rate
Methylene Blue MMX increases Adenoma Detection Rate 1 2 3 4 The adenoma ADR is a key In patients where at There is a clear and detection rate (ADR) colonoscopy quality least one adenoma is well-established is the percentage of measure found, the patient will connection between patients aged ≥50 go u
Slide 24: Methylene Blue MMX increases Adenoma Detection Rate
Methylene Blue MMX increases Adenoma Detection Rate 5 6 7 8 ADR HDWL 47.81% An absolute gain in We believe that the We will continue to versus Methylene ADR (including concerns raised by pursue regulatory Blue MMX 200 mg carcinomas) of 8.3% the FDA are fully approval for the 56.29%, p-value translat
Slide 25: Rifamycin SV MMX
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 H1 2019 subject to regulatory approval ➢ FDA granted both Qualified Infectious Dis
Slide 26: Rifamycin SV MMX
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 Q4 2018 ➢ IBS-D phase II trial started October 17, 25 sites, 342 patients, first
Slide 27: Rifamycin SV MMX
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
Slide 28: 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 end Q1 2019 ➢ Five years regulatory exclusivity as NCE ➢ Six patents granted, last
Slide 29: 2018 Outlook & Forecast
2018 Outlook & Forecast Alessandro Della Chà, CEO
Slide 30: Eleview US Market opportunity
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$
Slide 31: Eleview
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
Slide 32: Eleview
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
Slide 33: Methylene Blue MMX US Market Opportunity
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
Slide 34: Methylene Blue MMX US Market Opportunity
Methylene Blue MMX US Market Opportunity Physican Patient Payor • Methylene Blue MMX significantly • 81% of respondents patient would • Value is centered on improving clinical improves Adenoma Detection Rate proactively speak to their Doctor about outcomes and quality measures (ADR) a key colonscopy
Slide 35: 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 advantag
Slide 36: 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 acc
Slide 37: US Market Opportunity
US Market Opportunity Payors Landscape - Unmet Need: Physician Perceptions of Rifamycin: • Payors are generally satisfied with current • Sampled physicians consider Rifamycin SV MMX treatments but note that some treatments have to perform slightly better across all product limitations attributes • P
Slide 38: Remimazolam US Market Opportunity
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
Slide 39: Remimazolam US Market Opportunity
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 ➢ Midazo
Slide 40: Remimazolam US Market Opportunity
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 – $20
Slide 41: Aries Pharmaceuticals, Inc.
©)ARIES Pharmaceuticals, Inc. Member of Cosmo Pharmaceuticals NV Group e COSMO Pharmaceuticals
Slide 42: US Market Opportunity
US Market Opportunity ➢ 85-person organization in place as at June 2018 ➢ 61 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
Slide 43: US Market Opportunity
US Market Opportunity Estimated peak sales US: 7 - 8 years after launch Eleview Methylene Blue Rifamycin SV Remimazolam MMX MMX procedural sedation: US$65m - $75m US$600m - US$200m - US$150m - $700m $250m $200m 43
Slide 44: 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 44
Slide 45: Cosmo Pharmaceuticals NV
Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson’s Quay Dublin 2, Ireland [email protected] Mr. Alessandro Della Cha, CEO [email protected] Mr. John Manieri, IR [email protected] +353 1 817 03 70
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