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Product › Details


Products Next higher product group gastrointestinal drug_oo
Period Status 2017-07-28 development p3 existent
Organisations Organisation Dr. Falk Pharma GmbH
  Group Dr. Falk Pharma (Group)
  Organisation 2 Cosmo Pharmaceuticals N.V. (SIX: COPN)
  Group Cosmo Pharmaceuticals (Group)

Cosmo Pharmaceuticals N.V.. (7/28/17). "Press Release: Cosmo Half-Year Report 2017". Dublin.

Cosmo Pharmaceuticals N.V. (SIX: COPN) reports half-year results for the period ended 30 June 2017.


> Expansion of organization to commercialize products in the US progressed with the addition of further personnel with strong sales and marketing experience

> LuMeBlue NDA submitted to the FDA on 21 July 2017

> Zemcolo NDA under preparation

> Pre-marketing of LuMeBlue and Zemcolo commenced

> Successful results of a clinical trial comparing Eleview to the standard of care in endoscopic mucosal resection of large sessile polyps announced

> Zemcolo phase II clinical trial for a second indication for diarrhea-predominant irritable bowel syndrome (IBS-D) commenced

> Remimazolam successfully concluded its US Phase III clinical trial in procedural sedation in patients undergoing bronchoscopy

> Dr. Falk Pharma, the licensee for Europe and selected countries excluding the US, is preparing the EU Marketing Authorization submission for Zemcolo

> Qolotag was filed for approval in the EU as a medical device and approval was granted on 24 July 2017

> The Company received CHF102.8 million from the placement of 315,447 treasury shares and 618,500 ordinary shares created by the exercise of stock options

> Uceris royalty and manufacturing income in the first half of 2017 is an estimated EUR 12.1 million vs EUR 13.8 million in the same period last year as a result of lower Uceris net sales by Valeant, the lower income is an estimate based on TRX data as the Q2 report from Valeant has not been received yet

> Cosmo announced that it had filed for arbitration against Santarus Inc. and Valeant Pharmaceuticals Ireland Ltd. seeking the termination of its Uceris license agreement with Valeant and the transfer of the marketing authorization to Cosmo

Financial Highlights Half-Year 2017

> Revenue of EUR 31.8 million compared to EUR 31.6 million in prior year

> Net operating expenses EUR 36.1 million compared to EUR 19.4 million in prior year, EUR 13.4 million of costs associated with US sales and marketing organisation
> Operating loss EUR 8.4 million compared to an operating profit of EUR 8.8 million in prior year

> Financial expenses of EUR 11 million includes an unrealised loss of EUR 9.9 million on the Company’s US Dollar cash and investment bonds.

> Loss after taxes EUR 17.3 million compared to a profit of EUR 5.6 million in prior year

> Cash, cash equivalents and bond investments EUR 263.5 million at 30 June 2017

Key figures

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The Half-Year Report 2017 with further information was published on 28 July 2017, 07:00am CET, and is available for download at:

Confident Outlook

Cosmo has filed the NDA for LuMeBlue and expects to file the NDA for Zemcolo in the second half of this year. Selling, general & administrative expense costs will increase materially in 2017 due to the pre-marketing of LuMeBlue and Zemcolo and the build-up of the US organization. The Zemcolo phase II clinical trial for a second indication for diarrhea-predominant irritable bowel syndrome (IBS-D) commenced.

Alessandro Della Chà, CEO, said: “We have progressed building our US marketing and sales organization in the first half of this year. We have launched Eleview in the US, filed the LuMeBlue NDA and will file the Zemcolo NDA in the second half of this year. We are confident that approval will be granted for these products and we have commenced pre-marketing activity. We have the necessary liquidity in place to continue financing the set-up of our US marketing and sales organization and combined with our strong pipeline of products we expect our US organization to deliver substantial shareholder value. We are also continuing our out-licensing activities and we believe we shall be able to deliver interesting news in the second half of 2017”.

Half-year 2017 results conference call at 10:30am CEST on 28 July 2017
Alessandro Della Chà, CEO, Luigi Moro, CSO, Niall Donnelly, CFO and John Manieri, Head of IR, will present the half-year results and discuss the outlook for 2017 at a conference call to be held today at 10:30 am CEST.

The dial-in numbers:
+41 (0) 58 310 50 00 Continental Europe
+44 (0) 203 0595 862 UK
+1 (1) 631 570 5613 USA

The presentation is available for download at:

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 a medical device for polyp and adenoma excision and is has filed the NDA for LuMeBlue, 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 products 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:

Next events

Investora Conference September 20/21, 2017 in Zurich
Jefferies Global Healthcare Conference November 15/16, 2017 in London
Full-year results 2017 reporting March 2018
Annual General Meeting May 2018


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

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.

Record changed: 2017-08-02


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