COSMO FULL-YEAR REPORT 2018

Dublin, Ireland – 29 March 2019 – Cosmo Pharmaceuticals N.V. (SIX: COPN) reports Full-Year results for the year ended 31 December 2018. 


Financial Highlights Full-Year 2018

• Revenue €65.6 million compared to €67.2 million in 2017
• Operating costs €82.2 million compared to €76.8 million in 2017, the increase of €5.4 million mainly related to the U.S. organisation and an increase in R&D expenditure
• Operating loss of €16.6 million compared with an operating loss of €9.6 million in 2017
• Loss after tax of €18.1 million, including FX gain of €5.4 million on our US$ liquidity position compared with a loss after tax of €32.5 million in 2017
• Net proceeds of €163.4 million raised through the issue of a convertible bond
• Cash, bonds and investments €375.8 million, up €128.6 million compared to 2017

Key Events 2018 – Products and Business

The FDA approved Aemcolo™ (Rifamycin SV MMX) for the treatment of Travelers’ Diarrhea caused by non-invasive strains of Escherichia coli (E. coli) in adults, Aemcolo™ enjoys marketing exclusivity until 2028 with QIDP and 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. The Aemcolo™ phase II proof of concept study in IBS-D progressing. 
The Methylene Blue MMX NDA was not approved by the FDA who have stated that a confirmatory phase III trial is required to support the approval of the drug. Cosmo will commence a confirmatory phase III trial upon agreement of a new trial design with the FDA. The Methylene Blue MMX Marketing Authorisation Application was filed with the European Medicines Agency in February 2019.
Cortiment® net sales by our licensee Ferring increased by 12.1% to €15.1 million. A generic version of Lialda® was launched in the U.S. in March, as a result the Lialda income of Cosmo was reduced from €25.2 million to €20.7 million. The reduction in the U.S. income was partially offset by increases in Japan and Europe.
A generic of Uceris® was launched in the U.S. in July, as a consequence of which an authorised generic of Uceris® was launched by Bausch Health. The net sales both Uceris® and the authorised generic by Bausch Health declined by 28% to US$96.7 million and the Cosmo royalty and manufacturing income declined from €25.7 million to €17.5 million. 
Cosmo out-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. A 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. The company out-licenced 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 the 12th of July. The preparation of the NDA submission package is ongoing with filing of the NDA is expected by the end of Q1 2019.
The associate Cassiopea SpA, of which Cosmo owns 45.09%, communicated a sequence of very good news including the successful phase III clinical trial outcome of Winlevi for the treatment of acne and the successful phase II clinical trial interim analysis of Breezula for the treatment of Androgenetic Alopecia.


Key figures 

The Full-Year Report 2018 with further information was published on 29 March 2019, 07:00 am CET, and is available for download at: 

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

Outlook
Alessandro Della Chà, Chief Executive Officer, said: “During 2018 the FDA approved Aemcolo™. Dr. Falk Pharma also received approval via the European Decentralised Procedure for Relafalk® (Rifamycin SV MMX). We have progressed our Aemcolo™ phase II proof of concept study and we are setting the stage for further expansion in other indications. Our MB MMX NDA was not approved by the FDA who have requested a phase III confirmatory trial. We will commence this new phase III trial upon agreement with the FDA on the new trial design. Following this set-back we have reviewed our cost structure. In Q1 we have taken steps to reduce the cost base of our Aries organisation and we expect to achieve cost savings in the order of €15m in 2019 vs 2018. Our priorities for 2019 will be to launch Aemcolo™ and progress Remimazolam’s NDA, progress our product pipeline, reach agreement with the FDA on a new trial design for a confirmatory phase III trial for Methylene Blue MMX and start the trial. 

In 2019 we expect to reduce operating losses compared to 2018 to a level of approx. €12m and expect to return to profitability in 2020, the delay being caused by the non-approval of Methylene Blue MMX. 

The Company is financially very strong. We have significant opportunities and therefore we look to the future with optimism. In fact, the Company has been purchasing own shares in the market and currently owns approx. 2% of the issued shares. We have organized a comprehensive R&D day on May 8 in Zurich at which we will inform investors of our new product opportunities and our strategy going forward”. 


Full-Year 2018 results conference call at 10:00 am CET on 29 March 2018
Alessandro Della Chà, CEO and Niall Donnelly, CFO, will present the 2018 results and discuss the outlook for 2019. The conference will be held in English. 

Date:  Friday, 29 March 2018
Time:  10:00 am – 11:30 am CET
Venue:  Haus zum Rüden, Gotischer Saal, Limmatquai 42, 8001 Zurich

Participation is also possible via conference call.

The dial-in numbers are:
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 that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal Disorders and Endoscopic Procedures. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company has developed and launched in the US Eleview, a medical device for polyp and adenoma excision and it has filed the NDA for Methylene Blue MMX, a diagnostic drug for the detection of colon cancer, as well as new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX drugs that have reached the market are Lialda/Mezavant/Mesavancol, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Santarus/Salix/Valeant and in the Rest of the World to Ferring as Cortiment. Cosmo’s proprietary MMX technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com 


Contact:
John Manieri, Head of Investor Relations
Cosmo Pharmaceuticals N.V. 
Tel: +353 1 817 03 70
jmanieri@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.


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