MolMed Board of Directors Approves the First Half-Year 2012 Financial Report
FOR: MOLMED S.P.A.
AUG 2, 2012 - 12:42 ET
- NGR-hTNF: increased recruitment rate - with completion foreseen by the end of the year - in the Phase III mesothelioma trial, and new European patent granted
- TK: new strategy for marketing authorisation and amendment to the Phase III protocol
- Production for third parties: revenues more than doubled from EUR 931 thousand to EUR 2.2 million
MILAN, ITALY--(Marketwire - Aug. 2, 2012) - The Board of Directors of MolMed S.p.A. (MILAN:MLM), chaired by Professor Claudio Bordignon, today reviewed and approved the half-year financial report at 30 June 2012.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: "The first half-year confirms the positive trend already outlined in the first three months of 2012 in two fields of the Company's activities. The Phase III trial of NGR-hTNF in mesothelioma recorded a constant increase in the rate of patient recruitment, confirming the forecast of recruitment completion by the end of the year. At the same time, we would like to point out that revenues from development and GMP production for third parties in the field of gene therapy have more than doubled. Regarding TK, we are implementing protocol changes to include in the TK008 Phase III trial patients with more advanced disease. We believe that these changes will offer patients a better chance of cure and will help to increase the recruitment rate in the trial, which has been progressing below our expectations. Based on results accumulated in the Phase II trial and the initial data of the Phase III, the Company is pursuing a request through the Conditional Marketing Authorisation procedure, which might allow the Company to maintain its anticipated timelines for market authorisation in Europe."
|Highlights of financial data|
|Key income statements|
|(amounts in EUR thousand)||1st half-year 2012||1st half-year 2011||Change Absolute||Change %|
|Revenues from activities for third parties||2,203||931||1,272||136.6|
|Net financial income and charges||336||681||(345||)||(50.7||)|
|Result of the period||(10,716||)||(9,787||)||(929||)||9.5|
|Net financial position|
|(amounts in EUR thousand)||30 June
|31 December 2011||Change Absolute||Change %|
|Net financial position||28,912||38,667||(9,755||)||(25.2||)|
Key achievements in the first half-year 2012
Research & Development activities
In the first six months of 2012, the Company's activities were mainly focused on pursuing the clinical development of its investigational anticancer therapeutics, NGR-hTNF for the treatment of different types of solid tumours and TK for the treatment of high-risk leukaemia.
Main progress achieved in the development of NGR-hTNF included:
- increase of patient recruitment rate and further international expansion of the Phase III pivotal trial for the treatment of malignant pleural mesothelioma: as of 30 June 2012, well over half of the planned trial population was enrolled in 39 active centres in Europe, USA, Canada and Egypt, allowing MolMed to substantially confirm the foreseen patient recruitment completion by the end of 2012;
- progress of patient recruitment in four ongoing randomised Phase II trials, in non-small cell lung cancer (NSCLC), ovarian cancer, soft tissue sarcomas and mesothelioma as first-line maintenance therapy;
- presentation at ASCO 2012 of new data from four Phase II trials in as many types of solid tumours. The first randomised data for overall survival, available from the trial in metastatic NSCLC, are promising in the variant with squamous histology and confirm the extension of survival as the most significant clinical benefit common to the other three trials - in mesothelioma, ovarian cancer and small cell lung cancer. In all these trials, the onset of chills during drug infusion and high levels of circulating lymphocytes predict greater benefit from the treatment, consistently with the mode of action of the drug;
- grant of a new European patent (EP2285416) covering the therapeutic use of NGR-hTNF for the treatment of mesothelioma, affording protection until 2029 with the possibility of further term extension.
As regards TK:
- despite efforts to enlarge the number of clinical centres, patient recruitment is not in line with the Company's expectations, also due to delays in regulatory approval and in the activation of centres; this is most likely associated with the novelty of the technology and the need of regulatory authorities and centres to become familiar with it. The Company has decided to implement important changes in the design of the Phase III trial protocol, with the objective to provide additional clinical benefit to patients which should, in turn, expand the patient population and therefore address the delay in patient recruitment. The first change consists in widening the indication to patients in leukaemic relapse, in addition to those in disease remission. The second change provides for the introduction in the control arm of an additional treatment option, based on T-repleted transplant with post-transplant administration of cyclophosphamide. According to the Company's estimates, these changes double the number of patients eligible for recruitment in each centre and might significantly increase the potential participation of centres to the trial;
- as to the impact of these changes on the time to market, efficacy data gathered so far, both in Phase II and in the initial stage of Phase III, have led the Company to prepare a request for marketing approval through the Conditional Marketing Authorisation procedure. This request is based on clear evidence regarding the risk/benefit rate, safety, clinical efficacy and rarity of the indication. MolMed expects to file this request to the European authorities in mid-2013 and if the request is approved it would allow to comply with the Company's anticipated timeline for marketing authorization.
Development and GMP production for third parties
Development and production of new gene therapy treatments performed for third parties are consolidating the company's technological leadership in this field and are also generating a significant increase in revenues (as described in the comments to financials). During the first six months of 2012, work continued under two major agreements signed in 2011, respectively with Telethon Foundation and GlaxoSmithKline, for the development and production of new investigational gene therapy treatments for a total of seven rare genetic diseases. In addition, work has been carried out to upgrade and optimise the GMP production facility.
Comments to financials
Operating revenues in the first half-year 2012, amounting to EUR 2.4 million, had a sharp increase - up 84.1% compared to the first half-year of 2011 - due to the intensification of development and GMP production activities for third parties, which generated revenues of EUR 2.2 million compared to EUR 931 thousand in the corresponding period of 2011, up 136.6%, while income from activities carried out under co-funded projects, amounting to EUR 220 thousand, decreased compared to the corresponding period of 2011.
As expected, operating costs for the first six months of 2012 totalled EUR 13.5 million, up 14.3% compared to the first half-year of 2011.
The increase in operating costs is mainly due to intensified clinical development and to industrial development of NGR-hTNF, and to a small extent to the increase of development and GMP production activities for third parties.
Costs for services recorded an increase of 30.8%, consistent with the progress of development plans for NGR-hTNF and TK. More specifically, the increase is mainly due to the rise in external development and advisory costs related to the industrial development of NGR-hTNF and to the progress of clinical trials.
Costs for use of third-party assets, which essentially include rental costs for the Company's headquarters in Milan and secondary premises in Segrate, amounted to EUR 515 thousand in the first half-year 2012, with no significant change.
Personnel costs in the first half-year 2012 were slightly higher compared to the same period of 2011. The increase was maintained at 4.5% despite a higher increase in the number of employees in the Company's operating functions, following a strengthening of these functions due to the intensified development and production activities for third parties.
Other operating costs amounted to EUR 93 thousand in the first half-year 2012, with no significant changes over the first half-year 2011, while the 46.5% reduction of amortisation and depreciation reflects the completion in FY 2011 of the amortisation of costs capitalised in prior periods.
Investments made in the first half-year 2012 totalled EUR 219 thousand, mainly related to ordinary renewal of laboratory equipment and purchase of new equipment used in development and production processes, as well as to the upgrade and optimisation of the GMP facility.
The operating result for the first half-year of 2012 is negative for EUR 11.1 million. The increase of 5.6% in operating loss compared to the corresponding period of 2011 is due to the expected increase in operating costs linked to the development plans for the Company's investigational therapeutics.
Negative operating results are peculiar to the business model of biotech companies focused on R&D of new biopharmaceutical products and with no products on the market. At this stage high costs must be sustained for the clinical and pharmaceutical development of investigational therapeutics, whose return is deferred to future 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.
Net financial income and charges
Financial income is primarily derived from the management of the Company's cash through temporary, low-risk investments. The decrease of such income in the period is mainly due to the progressive reduction of financial resources due to the absorption of liquidity for ordinary business.
Result of the period
The result of the first half-year 2012 shows a loss of EUR 10.7 million, compared to a loss of EUR 9.8 million in the corresponding period of 2011.
Net financial position
The net financial position at 30 June 2012 amounted to EUR 28.9 million, including cash and cash equivalents for EUR 15.8 million and investments in current assets for EUR 13.3 million, net of EUR 182 thousand for lease payables for lease contracts of lab equipment.
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:
- Operating Result: defined as the difference between sales revenues and other income and costs for materials, costs of services received, costs for use of third-party assets, personnel costs and amortisation, depreciation & write downs. It represents the profit before financial flows and taxes;
- Net Financial Position: is the algebraic sum of cash, cash equivalents, financial receivables and other financial assets, and current and non-current financial debt.
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.
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of novel anti-tumour therapies. In addition to NGR-hTNF, MolMed's pipeline includes another novel therapeutic in clinical development: TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in Phase III in high-risk acute leukaemia. MolMed also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral vectors, and manufacturing of patient-specific genetically engineered cells. 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. (Ticker Reuters: MLMD.MI).
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 press release available on MolMed website (www.molmed.com).
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