Cosmo Pharmaceuticals Nv · SIX:COPN
Cosmo Pharmaceuticals Nv — Investor Presentation (November 2018)
29 slides from Cosmo Pharmaceuticals Nv's investor presentation, November 2018
Slide 1: Corporate Presentation
Corporate Presentation November 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 2018 YTD Financial Highlights Products and R&D Update 2018 Outlook & Forecast Questions & Answers 3
Slide 4: Key Events YTD 2018
Key Events YTD 2018 ➢ Methylene Blue MMX: the FDA ODE IV has denied our appeal. Cosmo is now drafting the subsequent appeal to the Office of New Drugs, which is the office that supervises the Office of Drug Evaluation IV (and all the others Offices of Drug Evaluation). Timeline for an answer will be
Slide 5: Key Events YTD 2018
Key Events YTD 2018 ➢ Aemcolo: Phase II proof of concept study in IBS-D progressing ➢ License and supply agreement entered into with Pharmascience for Eleview, Methylene Blue MMX, Aemcolo and Qolotag for the territory of Canada ➢ Eleview agreement with FUJIFILM Europe B.V. expanded to South East Asi
Slide 6: Financial Highlights YTD 30.09.2018
Financial Highlights YTD 30.09.2018 ➢ Revenue €50.1m versus €48.3m in prior year ➢ Uceris and Lialda income slightly decreased, offset by the increased Eleview sales and milestones/licenses fee ➢ Operating costs of €62.6m, up €7.4m versus prior year ➢ Cash, Bonds and Investment in Funds were €234m a
Slide 7: Financial Highlights YTD 30.09.2018
Financial Highlights YTD 30.09.2018 ➢ Cortiment net sales are up 11% versus last year and Cosmo income is up 13% (€2.7m) ➢ Eleview sales on track (expected 2018 gross revenue $11m) ➢ Uceris estimated net sales US$80.8m down 17.6% versus prior year. Manufacturing and Royalty Income down 19.6% to €14.
Slide 8: Statement of Financial Position 30.09.2018
Statement of Financial Position 30.09.2018 Cash, Bonds and Investments in Equity Funds €457.3m €234m 8
Slide 9: Products and R&D Update
Products and R&D Update Pharmaceuticals
Slide 10: Methylene Blue MMX: Formal Dispute Resolution
Methylene Blue MMX: Formal Dispute Resolution ➢ The first appeal on the CRL after the Type A meeting was filed at the FDA Office of Drug Evaluation (ODE) IV. The appeal was denied and a second trial was requested ➢ The next appeal to seek further review will be at the Office of New Drugs, Center for
Slide 11: Aemcolo – Commercialization
Aemcolo – Commercialization ➢ Timing: PDUFA for Traveller’s Diarrhea (TD) November 16, 2018; Launch planned for February 2019 with a wholesale price of $ 144 per box (12 tablets) ➢ Aries Team: Very experience US commercial team with extensive experience launching GI products ➢ Market • Enthusiastic
Slide 12: Aemcolo – Commercialization
Aemcolo – Commercialization ➢ Unique Product Attributes • Received FDA Qualified Infectious Disease Product (QIDP) designation for serious and life-threating infections • Colon-targeting release profile (MMX®) - the site of significant disease-causing bacteria • Only product to compare to ciprofloxa
Slide 13: Aemcolo – US Market Opportunity
Aemcolo – 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 ➢ Will be promoted by a sales force of 48 reps at onset ➢ Aemcolo sales forecast 20
Slide 14: Aemcolo – US Market Opportunity
Aemcolo – US Market Opportunity ➢ Physicians perceive advantages in the product over competitors ➢ Lower likelihood of developing resistance, efficacy in C-diff ➢ Based on a survey of 200+ physicians, they would prescribe Aemcolo in at least 1/3rd of the cases where they prescribe branded competitor
Slide 15: Aemcolo – US Market Opportunity
Aemcolo – US Market Opportunity ➢ Physician Perceptions of Aemcolo: ➢ Sampled physicians consider Aemcolo to perform slightly better across all product attributes ➢ Performance scores of 5.2-5.5/7 for all attributes ➢ Sampled physicians believe that Aemcolo perform moderately better than the SoC (5.
Slide 16: 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$92.50 per
Slide 17: Eleview – US Market Opportunity
Eleview – US Market Opportunity ➢ Launched at DDW in May 2017 ➢ Units October 2018: 2,684, Units May 2017 to October 2018: 24,492 ➢ Eleview forecast 2018: US$ 11m (gross sales), 2019: US$ 15m 17
Slide 18: Eleview – US Monthly Units
Eleview – US Monthly Units 2,800 2,684 2,600 2,400 2,200 1,958 1,955 1,977 1,922 1,930 2,000 1,776 1,731 1,800 1,650 1,586 1,600 1,338 1,400 1,287 1,200 1,021 1,000 800 692 572 600 400 314 200 74 25 - May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 J
Slide 19: Eleview – Cumulative Net Sales US$ May '17 to October '18
Eleview – Cumulative Net Sales US$ May ‘17 to October ‘18 $8,000,000 $7,703,177 $6,794,269 $7,000,000 $6,162,597 $5,634,087 $6,000,000 $5,088,785 $4,600,813 $5,000,000 $3,952,650 $3,595,297 $4,000,000 $3,009,801 $2,539,578 $3,000,000 $1,770,310 $1,383,851 $2,000,000 $979,543 $645,585 $1,000,000 $377
Slide 20: Remimazolam – Regulatory Approval Update
Remimazolam – Regulatory Approval Update ➢ 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 NC
Slide 21: Remimazolam – Physician Feedback
Remimazolam – Physician Feedback ➢ 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 22: Remimazolam – Commercial Opportunity
Remimazolam – Commercial 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 ➢ Mid
Slide 23: Remimazolam – Commercial Opportunity
Remimazolam – Commercial 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 –
Slide 24: US Organisation: Aries
US Organisation: Aries ➢ 82-person organization in place as at October 2018 (to be increased to 107 in 2019) ➢ 59 marketing and sales ➢ 10 MSL and Scientific Affairs ➢ 13 Management and Administration ➢ Eleview launched at DDW in May 2017 ➢ Aemcolo pre-launch activity underway ➢ Expected revenues 20
Slide 25: US Market Opportunity
US Market Opportunity Estimated peak sales US: 7 - 8 years after launch Eleview Methylene Blue Aemcolo Remimazolam MMX procedural sedation: US$65m - $75m US$600m - US$200m - US$150m - $700m $250m $200m 25
Slide 26: Cosmo: A Manager of Multiple Assets
Cosmo: A Manager of Multiple Assets License agreements Uceris/Cortiment for selected pipeline and 100% 45,09% products in Europe, Lialda/Mezavant/ Japan, Middle East, Mesavancol South East Asia, Franchise China, Canada US rights to successful phase III Eleview, Aemcolo, for Winlevi®, Undisclosed Rem
Slide 27: Key Priorities and Upcoming Milestones 2018-2019
Key Priorities and Upcoming Milestones 2018-2019 Appeal MB MMX decision within FDA Aemcolo PDUFA on November 16 2018 Progress Aemcolo IBS-D Phase II trial File Remimazolam NDA Partner pipeline in RoW 27
Slide 28: 2018 Cosmo Overall Guidance
2018 Cosmo Overall Guidance €M FY 2018 Traditional contract manufacturing and other revenue 11 Products manufacturing 27 Royalties 15 Licence fees, up-front fees and milestones 5 Aries U.S. sales 10 Total Revenues 68 Total Operating Expenses* (85) *Of which investment in Aries 36 Total EBITDA** (17)
Slide 29: Cosmo Pharmaceuticals NV Contact Details
Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson’s Quay Dublin 2, Ireland [email protected] Mr. Alessandro Della Chà, CEO [email protected] Mr. John Manieri, IR [email protected] +353 1 817 03 70
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