0RGI Cosmo Pharmaceuticals Nv

DUBLIN, March 26, 2021 /PRNewswire/ -- Cosmo Pharmaceuticals N.V. (SIX: COPN) reports Full-Year results for the year ended 31 December 2020.

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:

http://www.cosmopharmaceuticals.com/investor-relations/financial-reports 

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.

The dial-in numbers are:

Switzerland/Continental Europe:       +41 (0) 58 310 50 00

UK:                                                     +44 (0) 207 107 06 13

USA:                                                  +1 (1) 613 570 56 13

About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo^® to Red Hill Biopharma Ltd. for the US and has licensed Relafalk^® to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

Disclaimer

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.

This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.

This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.

This press release does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union (the "Prospectus Directive") of the securities referred to in it (the "Securities") in any member state of the European Economic Area (the "EEA"). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

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SOURCE Cosmo Pharmaceuticals N.V.