Cosmo makes significant progress in 2016

Financial highlights

• Operating revenues increased by 11.6% to € 67.7 million.
• Increase in personnel by 8%, operating costs down by 34.8% to € 43.0 million because of decrease in management bonus.
• Profit after tax of € 19.3 million (2015 results were primarily driven by the € 257.8 million gain on the sale of Cassiopea shares).
• Equity increased by 3.0% to € 415.5 million and equity ratio increased from 92.2% to 93.7%.
• Cash, cash equivalents and liquid financial assets decreased by 2.0% to € 238.5 million but more than ample to finance expansion into the USA.
• A dividend payment of EUR 1.5/share will be proposed at the next AGM on May 24, 2017.

2016 Key strategic events

• Excellent results of LuMeBlue® phase III trial with all primary and secondary end-points being met.
• Excellent Results of Rifamycin SV MMX® second pivotal phase III trial for Travellers' Diarrhoea with all primary and secondary clinical end-points being met.
• In-licensing of Remimazolam, a procedural sedation drug in phase III in the USA, from PAION AG.
• Set up of Aries Ltd. and Aries Inc. to market and distribute Cosmo's existing and future products in the USA.
• Cortiment® now marketed in 22 (+11) countries, approved in 42 (+8) countries, registrations pending in 18 countries and filings to be made in 29 more countries.

Key consolidated financial figures

The Annual Report 2016 is available here.

Confident outlook

Eleview® is scheduled to enter the market in the USA in May while in Europe the partnering process is currently underway. On the product development side Cosmo expects to file the NDAs for LuMeBlue® and Rifamycin SV MMX® in summer.

SG&A are expected to increase materially in 2017 with the US organization scheduled to grow from 16 to 95 persons. Overall, while there are some timing uncertainties, Cosmo expects to post another excellent year in 2017.

Alessandro Della Chà, CEO, said: "The excellent results of our phase III LuMeBlue® and Rifamycin SV MMX® trials have triggered the decision to set up our own US distribution organization. We are confident that both drugs will be approved. Setting up an organization in the US costs money up front, but we have ample liquidity to finance this. In the long run the US organization should substantially increase both our margins and strategic options. I think we are very well positioned to exploit our great potential."

FY16 results presentation and conference call at 10 am CET on 24 March 2017

Mauro Ajani, Chairman, Alessandro Della Chà, CEO, Luigi Moro, CSO and Chris Tanner, Head of Transactions Office and Investor Relations, will present the full year results and discuss the outlook for 2017 at a media and analyst conference to be held March 24 at 10.00 am CET in the Zunfthaus zum Rüden, Constaffelsaal, Limmatquai 42, 8001 Zurich.

Participation is also possible via conference call. The dial-in numbers:

The presentation will then be available for download here.

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 completed clinical trials of LuMeBlue®, a diagnostic 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: www.cosmopharma.com

Next events

Contact

Dr. Chris Tanner, Head of Transactions Office and Head of Investor Relations

Cosmo Pharmaceuticals NV.

Tel: +353 1 817 03 70