Cosmo Pharmaceuticals FULL YEAR REPORT

Transcription

1 FULL YEAR REPORT 2018

2 SAFE H ARBOUR 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 forward-looking 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. 1

3 AGENDA 01 INTRODUCTION AND 2018 KEY EVENTS Alessandro Della Chà, CEO FINANCIAL REVIEW Niall Donnelly, CFO OUTLOOK & KEY PRIORITIES Alessandro Della Chà, CEO 04 QUESTIONS AND ANSWERS Alessandro Della Chà, CEO 2

4 COSMO: 3 APPROVED PRODUCTS STEMMING FROM THE SAME TECHNOLOGY! 3

5 INTRODUCTION AND 2018 KEY EVENTS ALESSANDRO DELLA CHÀ, CEO 4

6 KEY EVENTS 2018 In November the FDA approved Aemcolo for the treatment of Traveller s Diarrhoea caused by non-invasive strains of Escherichia coli in adults Aemcolo enjoys marketing exclusivity until 2028 with the QIDP and the NCE designations Dr. Falk Pharma received approval via the European Decentralized Procedure for Relafalk (Rifamycin SV MMX) for the treatment of Travelers Diarrhea with marketing authorization granted in Germany, United Kingdom, Spain, Denmark, Greece, Finland, Hungary, Norway, Portugal, Poland, Sweden and Bulgaria. Launch is expected in Germany in 2019 and the other main EU countries in 2020 Our Aemcolo phase II proof of concept study in IBS-D is progressing, the trial is open in Belgium, Italy, Spain and Germany and recruitment is ongoing, in the meantime, we are also setting the stage for further expansion in other indications 5

7 KEY EVENTS CONTINUED The franchise of Lialda has grown in Japan and in the EU and that of Cortiment (Uceris ) all over the world, Cortiment is now approved in 61 countries, launched in 38 and under registration in 18 Generics were launched in the U.S. competing with Lialda and Uceris Eleview gross sales in the U.S. were $10.9m (2017: $2.1m) Net sales after royalty to Olympus were $7.5m 23,500 units were sold to end customers Exclusive distribution agreement with FUJIFILM Europe B.V. for Eleview was extended beyond Europe and South Africa to South East Asia, Middle East, Africa, Australia and New Zealand 6

8 KEY EVENTS CONTINUED Licenced Eleview, Methylene Blue MMX, Aemcolo and Qolotag for Canada to Pharmascience with an up-front payment of CA$5 million, additional commercial milestones and high double-digit royalties Regulatory submissions were made by Pharmascience to Health Canada for Methylene Blue MMX and Eleview, approval expected in the third quarter of 2019 Licensed Methylene Blue MMX and Eleview for Japan and South Korea to EA Pharma with an upfront payment, additional development and commercial milestone and royalties A pre-nda meeting for Remimazolam took place with the FDA on 12 July 2018, the preparation of the NDA submission package is ongoing with filing of the NDA expected by the end of Q

9 KEY EVENTS CONTINUED 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 and the successful Phase II clinical trial interim analysis of its drug Breezula for the treatment of Androgenetic Alopecia As at 27 March 2019, Cosmo s stake in Cassiopea had a market value of 184.5m compared to 134.2m as at 31 December

10 KEY EVENTS CONTINUED In November we successfully placed a 175m senior unsecured convertible bond due 2023, raising net proceeds of 163.4m The annual coupon is 2.5% and maturity is five years, so we believe we have raised capital at very favourable conditions Even more importantly, the essential feature of the bond is that we are entitled to reimburse it, if we elect to do so, using up to 2.4m Cosmo shares (which is a feature normally reserved to much larger issuers) This was especially crafted in order to reduce as much as possible the risk for Cosmo The bond gives us increased firepower at very attractive terms 9

11 KEY EVENTS CONTINUED Methylene Blue MMX NDA was not approved by the FDA, notwithstanding the Special Protocol Assessment agreement and the excellent trial results The dispute resolution process helped clarifying several issues but the FDA, while stating again that the completed phase III clinical trial has been successful and statistically significant, concluded that a phase III confirmatory trial is needed since Methylene Blue MMX is not intended to cure a disease but help the prevention of colorectal cancer and will likely be taken by millions of patients undergoing colonoscopy Cosmo has decided to present a new clinical plan encompassing different endpoints that will take into account all excellent findings of the completed phase III Upon agreement with the FDA on a new trial design we will immediately start a confirmatory phase III trial In February 2019 we filed a Marketing Authorisation Application with the European Medicines Agency 10

12 2018 FINANCIAL REVIEW NIALL DONNELLY, CFO 12

13 2018 FINANCIAL HIGHLIGHTS Revenue 65.6m vs 67.2m last year Operating costs increased by 5.4m to 82.2m Aries Inc operating costs 33.7m vs 30.3m of which: Personnel costs 18.2m vs 16.4m Other costs 15.5m vs 13.9m R&D costs 10.4m vs 9.0m Operating loss 16.6m vs 9.6m last year Net financial income 4.6m vs net financial expenses 16.9m last year Net FX gain in 2018 of 5.0m versus net FX loss of 18.4m in 2017 mainly related to /US$ FX rate movements Loss after taxes for the period 18.1m (2017: loss after tax of 32.5m) including share of Cassiopea loss 5.5m (2017: 5.9m) 13

14 INCOME STATEMENT EUR 1, Change Revenue 65,617 67,242 (1,625) Other income Cost of sales (22,058) (21,988) (70) Research and development costs (10,428) (9,049) (1,379) Selling, general and administrative costs (50,638) (46,279) (4,359) Net operating expenses (82,238) (76,846) (5,392) Operating loss (16,621) (9,604) (7,017) Net financial income/(expenses) 4,615 (16,936) 21,551 Share of result of associates (5,453) (5,892) 439 Loss before taxes (17,459) (32,432) 14,973 Income tax expenses (598) (15) (583) Loss after taxes for the period (18,057) (32,447) 14,390 14

15 INCOME STATEMENT - REVENUE Uceris EUR 1,000 (Unless otherwise stated) FY 2018 FY 2017 % Change Net Sales US$ $96,678 $134,170 (28%) Manufacturing Income 8,331 11,644 (28%) Royalty Income 9,199 14,078 (35%) Total Income 17,530 25,722 (32%) Uceris revenue reduced due to launch of generic in 2018 Cortiment EUR 1,000 (Unless otherwise stated) FY 2018 FY 2017 % Change Net Sales 15,105 13,476 12% Milestone - 1,000 n/a Manufacturing Income % Royalty Income 3,167 2,791 13% Total Income 3,868 4,412 (12%) 15

16 INCOME STATEMENT - REVENUE Lialda /Mezavant /Mesavancol EUR 1,000 FY 2018 FY 2017 % Change Manufacturing Income 18,483 24,050 (23%) Royalty Income 2,224 1,168 90% Total Income 20,707 25,218 (18%) Lialda /Mezavant /Mesavancol 20.7m (2017: 25.2m) a reduction of 4.5m. Reduction in US partially offset by increases in Japan and EU: USA 3.0m (2017: 13.0m) Japan 5.3m (2017: 1.1m) EU 9.0m (2017: 7.6m) Other 3.4 (2017: 3.5m) 16

17 INCOME STATEMENT - REVENUE Eleview EUR 1,000 FY 2018 FY 2017 % Change Units 25,462 5, % Total Income 6,760 1, % Licence fees, up-front fees & milestones and Generic & Other EUR 1,000 FY 2018 FY 2017 % Change Licence fees, up-front fees and milestones 5,705 1, % Generic & other 11,047 9, % Total income 16,752 11, % Up-front fees received from Pharmascience and EA Pharma and milestone received from Crinos SpA 17

18 INCOME STATEMENT - OPERATING EXPENSES Net operating expenses 82.2m (2017: 76.8m) COGS 22.1m (2017: 22.0m) R&D 10.4m (2017: 9.0m) Increase in clinical trials costs S G&A 50.6m (2017: 46.3m) Increase mainly due to full year impact of U.S. organisation Operating loss 16.6m (2017: 9.6m), with operating costs associated with our U.S. operations of 33.7m and revenue generated from U.S. sales of Eleview of 6.8m We have reviewed our cost structure following the unexpected set back with Methylene Blue MMX. In Q we commenced a restructuring of Aries and we expect to achieve cost savings in the order of 15m in 2019 compared to

19 INCOME STATEMENT Net financial income of 4.6m vs net financial expenses of 16.9m in 2017 Net FX gain of 5.0m vs net FX loss of 18.4m in 2017 Share of result of Cassiopea, loss of 5.5m (2017: loss of 5.9m) Loss before tax 17.5m (2017: 32.4m) Loss after tax 18.1m (2017: 32.5m) 19

20 STATEMENT OF FINANCIAL POSITION EUR 1, Change Non-current financial assets 41,855 93,811 (51,956) Investment in associates 130, ,742 (5,340) Other non-current assets 79,262 71,115 8,147 Cash and cash equivalents 210, ,944 65,745 Current financial assets 138,747 27, ,988 Other current assets 24,731 24, Total assets 625, , ,712 Non-current interest-bearing loans and borrowings 157,623 3, ,796 Other non-current liabilities 7,864 4,598 3,266 Current interest-bearing loans and borrowings (122) Other current liabilities 14,818 18,783 (3,965) Total liabilities 180,832 27, ,975 Net assets 444, ,117 (25,263) Equity attributable to owners of the Company 443, ,117 (26,357) Non-controlling interest 1,094-1,094 20

21 STATEMENT OF FINANCIAL POSITION - CONTINUED Other Non-Current Assets EUR 1,000 FY 2018 FY 2017 FY Change Property, plant and equipment 28,616 30,152 (1,536) Goodwill 1, ,330 Other intangible assets 35,524 28,525 6,999 Deferred tax assets 11,724 10,456 1,268 Other non-current receivables 1,959 1, Total other non-current assets 79,262 71,115 8,147 Other Current Assets EUR 1,000 FY 2018 FY 2017 FY Change Inventories 3,937 3, Trade receivables 12,762 13,190 (428) Current tax assets 5,231 2,972 2,259 Other receivables and other assets 2,801 5,200 (2,399) Total other current assets 24,731 24,

22 STATEMENT OF FINANCIAL POSITION - ASSETS Cash and investments in funds & bonds 375.8m (2017: 247.2m) Investment in associate Cassiopea 130.4m (2017: 135.7m), market value of 184.5m at 27 March 2019 Current and non-current tax assets 17.0m (2017: 13.4m) Trade receivables and inventory 16.7m (2017: 16.4m) Other investments 15.5m (2017: 19.4m) 22

23 STATEMENT OF FINANCIAL POSITION INTANGIBLE ASSETS EUR 1,000 FY 2018 FY 2017 FY Change - Methylene Blue MMX 9,835 9, Aemcolo 7,540 3,197 4,343 - Eleview 1,512 1,607 (95) - Remimazolam 2, ,238 Capitalised Development Costs 21,562 14,705 6,857 Remimazolam License 10,000 10,000 - Patents & Rights 3,867 3, Assets under Construction Total 35,524 28,525 6,999 23

24 STATEMENT OF FINANCIAL POSITION - CASH & FINANCIAL ASSETS EUR 1,000 FY 2018 FY 2017 FY Change Investments in Funds & Bonds 165, ,218 62,859 Investments 15,525 19,352-3,827 Total non-current & current financial assets 180, ,570 59,032 Cash 210, ,944 65,745 Total Cash, non-current & current financial assets 391, , ,777 Cash and Investments in Funds & Bonds 375, , ,604 % Bonds and Cash denominated in US$ 9% 47% 24

25 STATEMENT OF FINANCIAL POSITION - LIABILITIES Interest bearing loans and borrowings 158.2m (2017: 4.5m) Mainly liability component of convertible bond Current and Deferred tax liabilities 7.9m (2017: 5.8m) Trade payables 8.8m (2017: 11.3m) Other liabilities 5.9m (2017: 6.2m) Total Liabilities 180.8m (2017: 27.9m) 25

26 STATEMENT OF FINANCIAL POSITION SUMMARY Total Assets 625.7m Total liabilities 180.8m Equity 444.9m 26

27 CA SHFLOW EUR 1,000 FY 2018 FY 2017 Loss for the period before tax (17,459) (32,432) Income taxes paid (net) (4,156) (9,051) Adjustment for non-monetary item 14,906 33,376 Change in net working capital (3,455) (1,321) Net cash flows from operating activities (10,164) (9,428) Investments in property, plant and equipment (1,898) (12,289) Investments in other intangible assets (7,774) (9,746) Disposals of property, plant and equipment Net (outflows)/inflows from the investment in/disposal of financial assets (64,851) (5,619) Interest received 2,793 3,889 Net cash flow due to Linkverse acquisition (79) - Cash flows from investing activities (71,781) (23,729) 27

28 CA SHFLOW CONTINUED EUR 1,000 FY 2018 FY 2017 Repayments of interest-bearing loans and borrowings (665) (854) Change in other non-current receivables - (173) Purchase of treasury shares (18,353) - Capital increase / stock option exercise - 48,963 Sale of treasury shares - 47,290 Dividends paid - (22,556) Issue of convertible bond 166,250 - Transaction costs related to loans and borrowings (2,841) - Cashflows from financing activities 144,391 72,670 Net increase/(decrease) in cash and cash equivalents 62,446 39,513 Cash and cash equivalents at the beginning of the year 144, ,649 Net foreign exchange differences 3,299 (12,218) Total cash and cash equivalents at the end of the year 210, ,944 28

29 2019 OUTLOOK & KEY PRIORITIES ALESSANDRO DELLA CHÀ, CEO 29

30 NEAR TERM CATALYSTS Breezula full phase II results Remimazolam NDA filing R&D day in May and related announcements Winlevi NDA filing Aemcolo IBS-D phase II result 30

31 COSMO AS A SUM OF THE PARTS Cash, bonds and fund investments 375.8m Investment in Cassiopea 184.5m (as at 27 March 2019) Lialda /Mezavant & Uceris /Cortiment franchise Aemcolo Remimazolam Eleview Methylene Blue MMX Contract drug manufacturing Undisclosed pipeline (R&D Day) Investments in other companies 31

32 2019 ESTIMATES EUR Million 2019 E 2018 A Contract manufacturing and other Products manufacturing Royalties Licence fee, up-front fees and,milestones 1 6 U.S. sales 13 6 Total Revenues Operating Expenses* (72) (83) Operating loss** (12) (17) *Of which ESOP expenses 7.0m in FY19 & 9.0m in FY18 ** Excludes share of result of Cassiopea 32

33 KEY PRIORITIES FOR 2019 Launch Aemcolo File Remimazolam NDA Progress our product pipeline Restructuring of U.S. organisation Reach agreement with the FDA for new confirmatory phase III trial for Methylene Blue MMX and start trial 33

34 IN A NUTSHELL The Company is financially solid and has plenty of opportunities We look to the future with optimism We have been purchasing own shares and currently own approx. 2% of the issued shares See you at the R&D day on 8th May in Zurich!! 34

35 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