On March 26, 2021 Cosmo Pharmaceuticals N.V. (SIX: COPN) reported its Full-Year results for the year ended 31 December 2020 (Press release, Cosmo Pharmaceuticals, MAR 26, 2021, View Source [SID1234577220]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In 2020, Cosmo received European approval for Methylene Blue MMX, received FDA approval for BYFAVO, continued to execute its equity for product strategy and has returned to operating profit. The Company is very well positioned with €212.9 million in cash and significant equity stakes in other companies.
Financial Highlights Full-Year 2020
Revenue €60.9 million compared to € 62.5 million in 2019.
Net expenses €54.0 million compared to €74.8 million in 2019 following restructuring of business.
Operating profit of €6.9 million compared to an operating loss of €12.3 million in 2019.
Loss after tax of €7.9 million, including share of our associate Cassiopea loss of €4.9 million, compared with a loss after tax of €24.5 million in 2019.
Cashflow inflow from operating activities of €10.1 million compared to a cash outflow from operating activities of €17.6 million in 2019.
Cash & liquid investments €212.9 million compared to €268.2 million 2019, of which €45 million of the movement related to our investment in and loan to Acacia.
Market value of Cosmo’s stake in Cassiopea, equity investments, treasury shares, loans and cash & liquid investments at 31 December 2020 €624.6 million.
Equity €400.1m vs €393.7m at 31 December 2019.
Key Events 2020 – Products and Business
BYFAVO sub-licensed to Acacia Pharma Group (EURONEXT: ACPH) in an equity for product deal and subsequently approved by the FDA. Cosmo now owns 19.66% of Acacia and has advanced a €25 million loan to the company.
Very positive results of the first investigator initiated prospective clinical study of GI Genius announced, ADR (Adenoma Detection Rate) and APC (Adenoma Per Colonoscopy) were significantly higher in the GI Genius group compared to the control group.
GI Genius approved in Australia, Israel and the United Arab Emirates.
Methylene Blue MMX approved in Europe and European rights (plus Switzerland, the U.K., EEA countries, Russia and Mexico) subsequently licensed to Alfasigma S.p.A. in February 2021; protocol and related statistical analysis plan for the confirmatory phase III trial filed with the U.S. FDA for final comment and Chinese rights licensed to China Medical System Holdings Ltd.
Cosmo’s associate Cassiopea S.p.A. received FDA approval for Winlevi (clascoterone cream 1%) for the treatment of acne.
Italian Agenzia del Farmaco (AIFA) granted Marketing Authorisation for Stadmycin (Rifamycin SV MMX), licensed to E.G. S.p.A. (part of the STADA Group), for the treatment of Travellers’ Diarrhoea.
Japan’s Pharmaceuticals and Medical Devices Agency approved Eleview.
Licence agreement with Dr. Falk Pharma Gmbh (‘Dr. Falk’) amended to include Rifamycin SV MMX in the new 600mg formulation.
Successful outcome of phase II proof of concept (POC) clinical trial of Rifamycin SV MMX 600mg in Irritable Bowel Syndrome with Diarrhoea (IBS-D) announced in January 2021.
Key figures
Alessandro Della Chà, Chief Executive Officer, said: "2020 has been a year full of positive events for Cosmo. Methylene Blue MMX was approved in Europe, BYFAVO was approved by the FDA, Cassiopea, our associate, received FDA approval for Winlevi. We continued to execute our equity for product strategy, returned to operating profit and delivered a positive cash flow from operating activities. We have a very strong balance sheet, we are replenishing our development pipeline and we are confident that GI Genius will eventually be approved by the FDA. We therefore look to the future with optimism".
2021 Financial Outlook
Cosmo provided 2021 full year guidance, assuming approval of GI Genius by the FDA, of:
Full year revenues in the range of €60 – €64 million
Total expenses in the range of €57 – €59 million (of which ESOP €5.9 million and Depreciation & Amortisation €6.2 million)
Operating profit in the range of €3 – €5 million
The Full-Year Report 2020 with further information was published today on 26 March 2020, 07:00 am CET, and is available for download at:
Full-Year 2020 results conference call at 02:00 pm CET on 26 March 2021
Alessandro Della Chà, CEO and Niall Donnelly, CFO will present the 2020 results and discuss the outlook for 2021. The conference call will be held in English.