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  • Cosmo reports good 2010 operational results

    March 25, 2011

Strategic goals met – Confident outlook for 2011

Lainate, Italy – 25 March 2011 – Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today announced its results for the year ended 31 December 2010.

Financial highlights
– Total revenue increased by 20.1% to €32.0 million
– Royalties increased by 41.0% to €8.5 million
– Manufacturing of MMX® based products increased by 13.6% to € 7.7 million
– Other contract drug manufacturing revenue increased by 11.2% to €11.7 million
– One time license fees and milestones increased by 25.1% to €2.6 million
– Operating costs increased by 22.5% to €27.2 million
– Cost of sales increased by 12.1% to € 14.3 million
– Total research and development costs increased by 15.3% and reached €16.3 million
– €4.2 million reimbursed by partners (plus 5.5%)
– €6.8 million expensed (plus 51%)
– €5.4 million capitalized (plus 1.9%)
– Personnel increased by 3.0% to 138 FTEs
– EBITDA increased by 11% to €6.8 million
– Net profit reached €3.6 million, a decline by 10.9%, primarily because financial income decreased and one time financial expenses increased (primarily in conjunction with the BioXell acquisition)
– Cash and cash equivalents increased by 65.2% to €28.5 million amongst other because of the BioXell acquisition
– Financial assets available for sale decreased by 5.5% to €18.2 million primarily because the 7 m Santarus (NASDAQ: SNTS) shares declined in value by 29.2% to $3.27.

Operational highlights
– Lialda®, Cosmo’s first marketed MMX® product, had $293 million sales in 2010 and was the fastest growing 5-amino salicylic acid (“5-ASA”) drug in the Ulcerative Colitis market in the USA reaching a market share of 20.2% of all 5-ASA products.
– Progress was achieved in all research projects and clinical trials.

Strategic highlights
– On 30 September 2010 the Company announced that the primary clinical end point of the phase III Budesonide MMX® clinical trials in the USA was attained, on 8 November 2010, the Company announced that the primary clinical endpoint of the phase III – – Budesonide MMX® clinical trials in the EU had been attained.
– On 5 October 2010 the Company announced that it had attained a proof of concept for CB -03-01 in alopecia
– At the R&D day on 1 December 2010, the Company announced that it had attained a proof of concept for Methylene Blue MMX® a novel approach for the diagnosis of the colon diseases
– The BioXell transaction was completed on 12 March 2010

Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: “We are pleased to have achieved another set of good operational results and, more importantly, substantial progress across our development portfolio in 2010. We delivered on our objectives and are on solid ground, both financially and in our research and development projects. I believe that we have again made substantial progress in expanding the scope of our business and transforming Cosmo towards a premier specialty company that develops solutions for patients with colon diseases and also innovates in selected topically treated skin diseases. For 2011 we expect news flow re the filing of Budesonide MMX® in the EU and USA, expect to be able to report on the clinical progress of Rifamycin SV MMX® and Methylene Blue MMX® and we expect news on the strategic partnerships for CB 03-01 and LMW Heparin MMX®.”

→ Key consolidated financial figures

The Annual Report 2010 with further information was published on 25 March 2011 and is available for download at:〈=ENG

Confident outlook
Management is confident that sales of Lialda® in the USA and of Mezavant®/Mesavancol ® in the EU will continue to show healthy growth and that revenues from royalties and MMX® manufacturing will continue to increase in 2011. The Company expects to file the NDA for Budesonide MMX® in the EU and USA during the course of 2011. Cosmo intends to decide on its strategic partner for the development of CB-03-01 and possibly LMW Heparin MMX® in 2011.

In clinical development, the Company anticipates to progress Methylene Blue MMX®, intends to file an IND for CB-03-01 in the USA and to start its dose ranging phase II trial for the maintenance of remission of mild to moderate ulcerative colitis patients for LMW Heparin MMX® . Furthermore it expects news from its partners’ phase III trials for Rifamycin SV MMX® by year-end.

A strong emphasis will remain on cost control. Cost of goods is not expected to increase materially. Cosmo’s partners bear the cost of the phase III clinical trials for Rifamycin SV MMX®. However, the Company is developing a series of new programmes so the external cost of new clinical trials is likely to be similar to that of 2010. Overall, Cosmo expects to generate cash from operations and to post another operating profit in 2011.

The put option issued in conjunction with the takeover of BioXell in March 2010 will become exercisable between 1 July and 31 December 2011. The Company has sufficient cash to honour any shares that are put to it. The Company is under no obligation to place or destroy any of the shares that are potentially put to it and may opt to keep them for its ESOP.

FY10 results presentation and conference call at 10am CET on 25 March 2011
Mauro Ajani, CEO, Luigi Moro, CSO, and Chris Tanner, CFO and Head of Investor Relations, will present the full year results and discuss the outlook for 2011 at a media and analyst conference to be held today at 10am CET in Haus zum Rüden (Limmatquai 42, 8001 Zurich).

Participation is also possible via conference call. The dial-in numbers:
+41 (0)91 610 56 00 Continental Europe
+44 (0) 203 0595 862 UK
+1 (1) 866 291 41 66 USA

The presentation sis available for download at:

About Cosmo Pharmaceuticals
Cosmo is a speciality pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal and topically treated Skin Disorders. 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 is developing a new chemical entity for the topical treatment of Acne, Alopecia and Hirsutism. Cosmo’s first MMX® product that has reached the market is Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited. 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 intestines. For further information on Cosmo, please visit the Company’s website:

Next events
Annual General Meeting 21 April 2011, Lainate
Half-year results 2011 29 July 2011, Lainate

Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals S.p.A.
Tel: +39 02 9333 7614

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.