MolMed Board of Directors Approves the Financial Report for the First Half-Year 2011
- New Promising Results of Six Clinical Trials of Its Investigational Anticancer Drugs NGR-hTNF and TK, Including Data of a Randomised Phase II Trial of NGR-hTNF in Non-Small Cell Lung Cancer - Positive Net Financial Position of EUR 50.9 Million, Consisting Mainly of Cash and Other Current Financial Assets - Molmed's Financials Are Peculiar to the Business Model of Biotech Companies Developing New Therapeutic Products and Having No Products on the Market; at This Stage, High Costs Must Be Sustained for the Clinical and Pharmaceutical Development of Investigational New Drugs, and Return is Expected in Forthcoming Years
(firmenpresse) - MILAN, ITALY -- (Marketwire) -- 08/04/11 -- The Board of Directors of MolMed S.p.A. (MILAN: MLM), chaired by Professor Claudio Bordignon, today approved the half-year financial report at 30 June 2011.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, comments: "The new clinical data presented in June at ASCO 2011 demonstrate the quality, solidity and depth of our clinical development programme. For NGR-hTNF, we had further confirmed evidence of its promising antitumour activity, now observed in six different types of solid tumours, including both orphan indications and severe widespread cancers like non-small cell lung cancer. For TK, we have strengthened evidence of its direct role in providing immune protection against infections and leukaemia relapse. Both investigational products are in pivotal Phase III trials, and we are progressing in the international expansion of these trials in Europe and in the United States."
HIGHLIGHTS OF DEVELOPMENT ACTIVITIES
During the first half-year 2011, MolMed's activities were mainly focused on pursuing the clinical development of its investigational anticancer products, NGR-hTNF for the treatment of different types of solid tumours, and TK for the treatment of high-risk leukaemia.
Substantial progress achieved in the development of NGR-hTNF included:
In the area of development and GMP production, MolMed entered into an agreement with Fondazione Telethon to develop and manufacture novel investigational gene therapy treatments for six rare genetic diseases, worth up to EUR 8.3 million in revenues over a four-year period.
COMPANY ORGANISATION
In January 2011, MolMed significantly strengthened its top management and company organisation with the arrival of Germano Carganico as General Manager responsible for Research & Development and Operations, in charge of coordinating the final development stages and registration of MolMed's investigational therapeutics.
SUMMARY ON FINANCIAL RESULTS
MolMed's financials are peculiar to the business model of biotech companies developing new therapeutic products and having no products on the market. At this stage high costs must be sustained for the clinical and pharmaceutical development of investigational new drugs, and return is expected in forthcoming years. In addition, given the Company's operating activities and the characteristics of trials conducted, research and development costs are fully recorded in the period they are incurred.
Operating revenues
Overall, operating revenues totaled EUR 1.3 million in the first half 2011, with an increase of 11.7% compared with the same period of 2010.
At present, The Company's typical revenues are mainly generated from service activities related to development and production of investigational cell and gene therapy treatments, and in the first half of 2011 they were in line with those achieved in the same period of 2010. The positive effects of revenues stemming from the agreement recently signed with Fondazione Telethon are expected to materialise in the second half of 2011.
The increase of "Other income" was substantially due to R&D grants for projects co-funded by the European Union.
Operating costs
Operating costs totaled EUR 11.8 million, up 21.7% compared to the corresponding period of 2010, reflecting the intensification of development activities for MolMed's investigational therapies.
In particular, the increase in costs for raw materials and consumables, which largely consist of materials and reagents used in R&D activities, was linked to the NGR-hTNF industrial manufacturing process.
Costs for services recorded an increase consistent with the progress of development plans for the Company's investigational therapies. More specifically, the increase was largely due to the rise in external development and advisory costs relating to the NGR-hTNF industrial manufacturing process and to the progress of clinical trials of NGR-hTNF and TK.
Costs for use of third-party assets, mainly rental costs for the Company's headquarters in Milan and secondary premises in Segrate, amounted to EUR 0.5 million in the first half of 2011, with no significant change.
Personnel costs in the first half of 2011 were higher than those recorded in the same period of 2010 because of an increase in the number of employees, in order to strengthen the Company's operating functions in view of the intensification of production and development activities.
Other operating costs, which amounted to EUR 82 thousand, and amortisation, depreciation and write-downs, which totalled EUR 0.6 million, are in line with those of the same period of 2010.
Investments made during the period totaled EUR 0.1 million, and were mainly related to ordinary renewal of laboratory equipment and purchase of new equipment used in production processes.
Operating result
The planned increase in operating costs, due to the Company's product development plans, resulted in a negative operating result of EUR 10.5 million in the first half of 2011, with an increase of 23.1% compared to the same period last year.
Net financial income and charges
Financial income mainly resulted from the management of cash and cash equivalents through temporary, low-risk investments. The increase in the period was linked to the investment of the financial resources obtained through the share capital increase completed in August 2010.
Result for the period
The result for the first half-year of 2011 is negative for EUR 9.8 million, compared to a negative result for EUR 8.6 million in the first half of 2010.
Net financial position
The trend in the net financial position, from EUR 60.0 million at 31 December 2010 to EUR 50.9 million at 30 June 2011, is connected to the absorption of financial resources required to run the Company's ordinary business.
The net financial position as of 30 June 2011 included cash and cash equivalents for EUR 5.8 million and other current financial assets for EUR 45.4 million, net of EUR 0.3 million for lease payables connected with lease contracts for laboratory equipment.
Taking into account current financial receivables and other financial assets, cash absorbed in the period amounted to EUR 9.2 million (EUR 1.5 million per month on average), and was entirely due to the Company's ordinary operations.
The official Corporate Financial Reporting Manager of MolMed S.p.A., Enrico Cappelli, herewith attests, pursuant to Article 154-bis, paragraph 2 of the Italian Consolidated Law on Finance (Legislative Decree 58/1998), that the accounting disclosure contained in this press release matches documentary evidence, corporate books and accounting records.
In this press release, use is made of "alternative performance indicators" which are not provided for under European IFRS, and whose significance and content - in line with Recommendation CESR/05-178b published on November 3, 2005 - are illustrated below:
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian securities & exchange commission) resolution no. 11971 of 14.5.1999 as subsequently amended.
About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel antitumour therapies. MolMed's pipeline includes two novel therapeutics in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular targeting agent (VTA), in Phase III in malignant pleural mesothelioma and in Phase II in six more indications: colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed is headquartered at the San Raffaele Biomedical Science Park in Milan, Italy. The company's shares are listed on the Milan Stock Exchange, at the Standard segment (class I) of the MTA managed by Borsa Italiana.
DISCLAIMER
This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, including scientific, business, economic and financial factors, which could cause actual results to differ materially from those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking statements or adapt them to future events or developments. This document does not constitute an offer or invitation to subscribe or purchase any securities of MolMed S.p.A.
FULL VERSION OF THIS PRESS RELEASE IS AVAILABLE ON MOLMED'S WEBSITE
Contacts:
Investor Relations: MolMed S.p.A.
Holger Neecke
Director Business Development & Investor Relations
+39 02 21277.205
+39 02 21277.325 (FAX)
Administration, Finance & Control: MolMed S.p.A.
Enrico Cappelli
Chief Financial Officer
+39 02 21277.302
+39 02 21277.325 (FAX)
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Datum: 04.08.2011 - 11:24 Uhr
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