COSMO HALF-YEAR REPORT 2018

Dublin, Ireland – 26 July 2018 – Cosmo Pharmaceuticals N.V. (SIX: COPN) reports half-year results for the period ended 30 June 2018. 

Financial Highlights Half-Year 2018

• Revenue up 15.2% to €36.7m driven by up-front license fees
• Operating costs up 21.4% to €43.9m mainly due to the build-up of the U.S. operation 
• Operating loss €7.2m vs €4.3m last year 

• Net finance income €4.8m related to € / US$ FX rate movement 
  
• Loss for the period €7.8m including share of Cassiopea loss €2.9m
  
• Cash and investments in funds and debt securities €230.2m vs €247.1m at FY17 YE
  
• Total assets €479.6m vs €498.0m at FY17 YE
• Equity €456.4m vs €470.1m at FY17 YE

Key Events 2018 – Products and Business

• Complete response letter received from FDA in relation to Methylene Blue MMX NDA. NDA not approved in current form. Type A meeting held with FDA on 25 July 2018, the outcome will be communicated once available. 

• Rifamycin SV MMX New Drug Application seeking marketing authorisation for the treatment of Traveler’s Diarrhea accepted by the FDA. PDUFA date of 16 November set by FDA to complete their review. 
  
• Rifamycin SV MMX phase II proof of concept study in IBS-D progressed.
  
• Eleview gross sales in the U.S. $4.6m vs $2.1m in H2 2017.   
• License and supply agreement entered into with Pharmascience for Eleview, Methylene Blue MMX, Rifamycin SV MMX and Qolotag for the territory of Canada.
• Eleview agreement with FUJIFILM Europe B.V. expanded to South East Asia, Middle East, Africa, Australia and New Zealand. Cosmo to receive 45% of gross revenues. 
• License and supply agreement entered into with EA Pharma for Methylene Blue MMX and Eleview for the territories of Japan and South Korea. 
• 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 its drug Winlevi for the treatment of acne. As at the 24 July 2018, Cosmo’s stake in Cassiopea has a market value of €193.5m compared to €134.2m as at 31 December 2017. 
• ICC Tribunal ruled that Valeant was not in breach of the Uceris License Agreement. 

The Half-Year Report 2018 with further information was published on 26 July 2018, 07:00 am CET, and is available for download at: 
http://www.cosmopharmaceuticals.com/investor-relations/financial-reports

Alessandro Della Chà, Chief Executive Officer, said: “In H1 we grew revenue by 15.2% and our operating loss was €7.2m. The first half of this year presented challenges for Cosmo however we remain firmly focused on executing our strategy. The FDA did not approve our Methylene Blue MMX NDA in its current form and provided recommendations for resubmission. This was an unexpected setback and we believe the issues raised are addressable. We are strongly committed to working with the FDA to obtain regulatory approval for the drug. A Type A meeting took place with the FDA on 25 July and the outcome will be communicated once available. Separately, the FDA has accepted our Rifamycin SV MMX NDA seeking marketing authorisation for the treatment of Traveler’s Diarrhea and have set a PDUFA date of 16 November. Subject to regulatory approval, we expect to launch Rifamycin SV MMX in the U.S. in the first half of 2019 and have commenced pre-commercialisation activities. We have progressed our Rifamycin SV MMX IBS-D Phase II trial and also our out-licensing activities by signing license and supply agreements with Pharmascience and EA Pharma. We expect to file the NDA for Remimazolam by Q1 2019.”

Half-Year 2018 Results Conference Call on 26 July 2018, 15:00 – 16:00 h CET
Alessandro Della Chà, CEO, Luigi Moro, CSO, Niall Donnelly, CFO, John Manieri, Head of Investor Relations will present the half-year results 2018 and will provide an update of Cosmo’s pipeline. The conference call is scheduled to last 30-45 minutes and will be held in English.

Dial-in numbers:
From Continental Europe:  +41 (0)58 310 50 00
From UK:  +44 (0)203 059 58 62
From USA:  +1 (1) 613 570 56 13

The presentation is available for download at: 
http://www.cosmopharma.com/ir/presentations.aspx  



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 Eleview, a medical device for polyp and adenoma excision, in the U.S. and it has filed the NDA for Methylene Blue MMX, a diagnostic drug for the detection of colon cancer. In addition, new chemical entities are being developed by its associate company Cassiopea S.p.A. for the topical treatment of skin diseases. Cosmo’s MMX drugs already on the market are Lialda/ Mezavant/Mesavancol, a treatment for IBD that is licensed globally to Giuliani and Shire and Uceris, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in the U.S. 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

Next events 
Jefferies Global Healthcare Conference November 2018 in London
Full-year results 2018 reporting March 2019
Annual General Meeting May 2019
 
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.
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.