COSMO HALF-YEAR REPORT 2019

Dublin, Ireland – 30 July 2019 – Cosmo Pharmaceuticals N.V. (SIX: COPN) reports half-year results for the period ended 30 June 2019. 

Key Events Half-Year 2019 – Products and Business

• Revolutionary artificial intelligence product GI Genius for the detection of lesions during colonoscopy unveiled and subsequent worldwide validation deal entered into with Medtronic.
• Collaboration agreement entered into with Medtronic in the artificial intelligence field for additional indications.
• Eleview® distribution agreement entered into with Medtronic for USA, China and South America with sales expected to begin in August 2019. 
• Investigational New Drug (IND) for new chemical entity CB-03-10 for new oncologic product accepted by the FDA
• ByFavo™ (remimazolam) NDA accepted by the FDA. 
• Aries restructuring completed, savings of c. €20m expected in 2019. 
• Very positive results of Breezula® full phase II clinical trial announced by our associate Cassiopea. 
• Aemcolo™ phase II proof of concept study in IBS-D progressed. 
• Health Canada approved Eleview® which will be commercialised by Pharmascience under the existing licence agreement. 
• GI Genius to start sales in Europe in July 2019 by Medtronic.
• Aemcolo™ commercial launch to take place end of July 2019 with direct marketing strategy.

Alessandro Della Chà, Chief Executive Officer, said: “In the first half of this year we took a number of key steps. Following the regulatory delay of MB MMX we have reduced our U.S. cost base significantly; announced new interesting product opportunities (GI Genius and CB-03-10); entered into important deals with Medtronic; shifted strategy for our medical devices and for the Aemcolo launch. In doing so, we are not expecting significant impact on financial results this year, but rather to lay a solid foundation for things to come.” 

“Although our focus is to achieve US approval for GI Genius in H1 2020, sales have already started in Europe; Aemcolo launch in the US is still on track for end of July and Eleview sales in the US will be reinitiated in August by Medtronic,” added Mr Della Chà. “As of June 30, the total of cash and investment in funds, market value of our Cassiopea stake and treasury shares is approx. € 539m/CHF 590m, providing ample financing and flexibility to pursue our strategy for growth. We look to the future with optimism. 2020 will be a pivotal year for us, when we expect to return to profitability.”

Financial Highlights Half-Year 2019

• Revenues €21.5m vs €36.7m last year, impacted by the generic competition for Uceris® and Lialda® in 2018 and up-front fees and milestones received in prior year which did not reoccur. 
• Operating costs down 11.8% to €38.7m following cost reductions in our U.S. organisation.  
• Operating loss €17.2m vs €7.2m last year.  
• Net financial expense €2.6m mainly relates to interest on convertible bonds of €4.1m of which cash impact €2.2m.  
• Loss for the period €20.8m including share of Cassiopea loss €2.8m, ESOP costs of €3m and €4.1m convertible bond charge of which € 2.2m coupon paid.  
• Cash outflow from operations before changes in working capital €11.0m for the period.
• Cash and investments in funds €324.0m vs €375.8m at FY18 YE (excluding €35.5m treasury shares). 
• Cosmo’s stake in Cassiopea worth €180m at 30 June 2019. 
• Total assets €594.7m vs €625.7m at FY18 YE.
• Equity €404.4m vs €444.8m at FY18 YE. 
• Purchased 212,214 treasury shares in H1 for €17.2m. As at 30 June 2019 total treasury shares held 413,984.    
   

Key figures 

The Half-Year Report 2019 with further information was published on 30 July 2019, 07:00 am CET, and is available for download at: 
http://www.cosmopharmaceuticals.com/investor-relations/financial-reports


Half-Year 2019 Results Conference Call on Tuesday, 30 July 2019, 10:30am CET
Alessandro Della Chà, CEO, Luigi Moro, CSO, Niall Donnelly, CFO will present the half-year results 2019 and will provide an update of Cosmo’s activities. 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)207 107 06 13
From USA: +1 (1) 631 570 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 focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and 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 its novel Artificial Intelligence device to be used in coloscopies and GI procedures. Further, Cosmo is the licensee for US of the novel agent for procedural sedation, ByFavo™ (remimazolam). For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com

Next events 
Full-year results 2019 reporting March 2020
Annual General Meeting May 2020
 

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. 

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