Cosmo reports excellent first half; new product sales exceed expectations and important progress is attained in products in development strong increase in profits Lainate, Italy - 31 July 2013 - Cosmo Pharmaceuticals S.p.A. (SIX: COPN) announced today its half-year results for the period ended 30 June 2013. Highlights *Uceris®, launched in February in the USA, has exceeded all expectations. *The FDA agreed to the Special Protocol Assessment of Methylene Blue MMX® thus allowing green light for start of phase III clinical trials in the USA: EU in H2 2013. *Lialda® continues gaining market share. *Phase III clinical trials for Rifamycin SV MMX® in India re-opened. *A financial gain of EUR 58.2 million was attained on the sale of a part of the investment in Santarus. Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: "I am very pleased with the first half 2013. I always believed that the approval of Uceris® and Cortiment® would be a major strategic step for Cosmo; my expectations have been far exceeded by the reports on first prescriptions and sales of Uceris®. When investors rewarded our Uceris® licensee Santarus with a further strong increase of the share price, we decided to partially cash in on our investment and made eight times our 2008 investment. This is very gratifying considering that our relationship with Santarus continues developing smoothly. Thanks to excellent support in the medical community who helped us design the phase III clinical trial protocols for Methylene Blue MMX® we got the FDA to approve the Special Protocol Assessment we requested. Phase III clinical trials of Methylene Blue MMX® are now scheduled to start in H2 2013. The longer we can wait in taking on a partner, the better our economic terms are likely to be. I am convinced that Methylene Blue MMX® will help save many, many lives by helping to improve the diagnosis of colon cancer and that it will become the most important product of Cosmo. Last but not least, the Indian Authorities have authorized our licensee Dr. Falk Pharma to continue with their phase III clinical trials of Rifamycin SV MMX®. Data from these trials is necessary for the filing of Rifamycin SV MMX® both in the USA as well as in the EU." In the first six months, Lialda® continued gaining market share and Uceris® was launched in the USA. Overall royalties thus increased by 30.9% to EUR 7.3 million and revenue from manufacturing of MMX® products increased by 9.8% to EUR 8.4 million. Revenue from generics and contract drug manufacturing also increased slightly, but the decision to postpone negotiations on the licensing of Methylene Blue MMX® meant that only EUR 5.2 million revenue (from the USD 7.0 million milestone achieved due to the first sale of Uceris®) were generated. Overall operating revenue reached EUR 26.6 million. Financial income increased substantially due to the decision to sell part of the Company's holdings in Santarus. 4'887'500 SNTS that had been purchased at EUR 1.77 were sold for USD 18.25 per share creating a net profit of EUR 58.2 million. Net operating expenses increased by 27.7% to EUR 19.9 million. Total personnel employed remained at 161 persons but personnel expenses increased by EUR 1.6 million or 34.1% because a one-off goal attainment payment was made to all employees after the approval of Uceris®. Costs for outsourced pre clinical and clinical trials only increased slightly by 1.5%. Cost of sales increased primarily because of the new costs related to the outsourced packaging of Uceris®. Depreciation and amortization expense increased by 128.7% to EUR 2.7 million. This is due to the fact that, with the acquisition of Cristoforo Colombo Real Estate S.r.l. in September 2012, property plant and equipment increased substantially and because the amortization of the capitalized R&D costs of Budesonide MMX® (Uceris® and Cortiment®) has started. The operating result consequently declined to EUR 6.7 million but, due to the gain on the sale of the Santarus shares, the profit after tax for the period increased by 238.6% to EUR 63.3 million. The basic profit per share, dividing the net profit attributable to shareholders by the weighted average number of ordinary shares during the period, reached EUR 4.514 up more than three times in comparison to the first half of 2012. Cash and cash equivalents at the end of the period totalled EUR 95.1million, an increase of EUR 67.8 million or 248.5% from the end of last year. Financial assets available for sale decreased by EUR 14.8 m or 22.5% because of the decreased holdings of Santarus shares. In the first six months the Santarus share price increased from USD 10.98 to USD 21.05. Key consolidated financial figures In EUR million (with the exception of the share data in EUR) 1H 2013 1H 2012 Revenue 26.6 40.7 Cost of sales (9.5) (7.8) Research and development expenses (5.8) (4.4) Selling, general and administrative expenses (4.6) (3.4) Operating result 6.7 25.2 Net financial income 58.2 0.7 Profit before taxes 64.9 25.9 Profit after taxes for the period 63.3 18.7 Profit per share 4.51 1.38 30.6.2013 31.12.2012 Cash and cash equivalents 95.1 27.3 Financial assets available for sale 51.2 66.1 Total assets 207.3 151.8 Liabilities 25.0 27.2 Equity attrib. to owners of the company 182.2 124.4 The Half-Year Report 2013 with further information was published on 31 July 2013, 7am CET, and is available for download at: http://www.cosmopharma.com/ir/first-half.aspx Outlook Management expects strong growth in Uceris® sales and also expects Lialda® sales to continue growing at historical levels in H2. Furthermore the launch of Cortiment® is expected in the Netherlands. This will drive MMX® manufacturing revenues and royalties. It is expected that the phase III Methylene Blue MMX® trials in the USA and EU will kick off in H2 and that Rifamycin SV MMX® trials will resume in India. Half year 2013 results conference call at 10:30 am CEST on 31 July 2013 Mauro Ajani, CEO, Luigi Moro, CSO, and Chris Tanner, CFO, will present the half year results and discuss the outlook for 2013 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: http://www.cosmopharma.com/ir/presentations.aspx 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 colonic inflammatory and infective diseases. In addition, the Company is developing a diagnostic for the detection of colon cancer and a new chemical entity in the dermatogical area for the topical treatment of Acne, Alopecia and Hirsutism. Cosmo's first product in the market is Lialda®/Mezavant®/Mesavancol®, a treatment for mild to moderate Ulcerative Colitis that is licensed globally to Giuliani and Shire. Cosmo's second product is Uceris(TM)/Cortiment(TM), a steroid without the typical side effects of systemic steroids, that is indicated for Ulcerative Colitis patients and is licensed globally to Santarus and Ferring. 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 lower part of intestines. For further information on Cosmo, please visit the Company's website: www.cosmopharma.com Next events Full-year results 2013 reporting 27 March 2014 Annual General Meeting 16 April 2014 Contact: Dr. Chris Tanner, CFO and Head of Investor Relations Cosmo Pharmaceuticals S.p.A. Tel: +39 02 9333 7453 email@example.com 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. Media release (PDF) Provider Channel Contact Tensid Ltd., Switzerland newsbox.ch Provider/Channel related enquiries www.tensid.ch www.newsbox.ch firstname.lastname@example.org +41 41 763 00 50
Cosmo reports excellent first half
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