Press telephone conference today, 9:30 a.m. (CET)
Analysts' telephone conference with webcast (English) today, 2:00 p.m. (CET)
All 2011 financial targets met:
Positive net result for the year: EUR 6.3 million (2010: EUR -17.9 million)
Continuous increase of revenue from continued operations to EUR 4.7 million
(2010: EUR 2.3 million)
and revenue from discontinued operations EUR 27.8 million
EBITDA: EUR 11.2 million (2010: EUR -12.8 million)
Main developments in product portfolio:
Veregen®: progress in approval and marketing
EndoTAG®-1: presentation of final data from clinical phase II trial in TNBC
RhuDex®: resumption of the clinical development
AAVLP: presentation of positive data from preclinical studies
2012 outlook - higher revenue and increased investment in clinical development of RhuDex®
Funding of the company secured beyond 2013
Martinsried/Munich, March 23, 2012. MediGene AG (Frankfurt, Prime Standard, MDG) achieved positive results for fiscal year 2011 and met its financial guidance. The company doubled revenue from continued operations to EUR 4.7 million (2010: EUR 2.3 million) and recorded revenue from discontinued operations totaling EUR 27.8 million (2010: EUR 47.4 million). In addition, Medigene achieved positive EBITDA of EUR 11.2 million (2010: EUR -12.8 million) while net profit amounted to EUR 6.3 million (2010 net loss: EUR -17.9 million). At the end of the fiscal year, the balance of cash and cash equivalents was EUR 12.8 million (December 31, 2010: EUR 4.8 million). The results were compiled in accordance with IFRS (International Financial Reporting Standards).
Major events in 2011 fiscal year:
Completed transfer of Eligard® rights for EU countries to Astellas
Granted market approval for Veregen® in Spain
Submitted applications for marketing authorization of Veregen® in a further 17 European countries (March 2012: positive decision by regulatory authorities)
Signed seven Veregen® partnership agreements for 25 countries
Presented overall survival data on EndoTAG®-1 from the phase II trial in triple-negative breast cancer (TNBC)
Initiated IIT phase II study (investigator initiated trial) of EndoTAG®-1 in HER2-negative breast cancer by Institute Jules Bordet
Developed new formulation concept for RhuDex® in preclinical trials
Received official approval to conduct formulation trial for RhuDex® (January 2012: trial starts)
Signed development collaboration agreement with Johns Hopkins University to test the first vaccine candidates of the AAVLP platform
Presented positive data on AAVLP vaccine program together with the German Cancer Research Center (DKFZ)
Dr. Frank Mathias, Chief Executive Officer of Medigene, comments: "2011 was an important year for our company, in which we successfully took significant steps towards implementing our strategy for long-term growth. Our three core objectives were achieved: We increased the company's financial capabilities, optimized the cost structure and strengthened our drug pipeline. In particular the resumption of the clinical development of drug candidate RhuDex® with a new formulation concept is important progress for our pipeline."
Arnd Christ, Chief Financial Officer of Medigene, adds: "In fiscal year 2011, Medigene once again considerably improved its EBITDA and revenue for the year - even when adjusted for one-time effects - and met the forecast targets for 2011. With the financial resources available, we can successfully carry out the upcoming tasks, and we believe the company's funding is secured beyond 2013. We consider ourselves both financially and structurally well-positioned for future growth."
Financial result for 2011 fiscal year:
Product sales and other income
In 2011, Medigene increased revenue from continued operations by 103% to EUR 4.7 million (2010: EUR 2.3 million) and achieved revenue from discontinued operations totaling EUR 27.8 million (2010: EUR 47.4 million), amounting to EUR 32.5 million in total. Thus, the company's 2011 total revenue forecast of EUR 32 to EUR 33 million was achieved.
Revenue from continued operations was generated by the commercialization of Veregen® in the USA, Germany and Austria amounting to EUR 2.1 million (2010: EUR 1.5 million), as well as from milestone payments for Veregen® of EUR 0.2 million (2010: EUR 0.7 million). Other operating income amounted to EUR 2.4 million (2010: EUR 0.1 million). Since March 2011, this has been comprised of a 2% royalty share amounting to EUR 2.2 million of the net sales of Eligard® achieved by Astellas.
Revenue from discontinued operations was comprised of milestone payments of EUR 20 million, which Medigene posted in connection with the transfer of the EU Eligard® rights to Astellas on March 1, 2011. The Eligard® product sales achieved and license payments received through the end of February 2011 are also reported under this item.
Selling, general and administrative expenses from continued operations decreased year-on-year from EUR 9.4 million (2010) to EUR 8.1 million (2011). This amount consists of EUR 2.3 million (2010: EUR 2.0 million) in selling expenses and EUR 5.8 million (2010: EUR 7.4 million) in general administrative expenses, which were reduced by 21 %.
Total expenses for research and development (R&D) were down to EUR 11.3 million (2010: EUR 13.5 million). A large part of the cost for research and development consisted of expenses for the evaluation of the clinical trial with the drug candidate EndoTAG®-1 for the indication triple-negative breast cancer. In addition, the write-down of an early-stage research project that Medigene is no longer pursuing was posted as a EUR 3.8 million expense. Other costs arose in connection with additional development projects.
EBITDA and net result for the year
In 2011, Medigene's profit based on EBITDA amounted to EUR 11.2 million (2010: EBITDA EUR -12.8 million). Net profit for the year amounted to EUR 6.3 million compared with a net loss of EUR -17.9 million in the previous year. Medigene had forecast EBITDA of EUR 10 to 12 million for 2011.
Monthly cash inflow/burn from operating activities
The consolidated statement of cash flows for 2011 shows an average monthly net cash inflow from operating activities of EUR 0.6 million (2010: cash burn rate of EUR -1.0 million). Adjusted by one-time effects, the monthly cash burn rate from operating activities for 2011 was an average of EUR -0.8 million (2010: EUR -1.4 million).
|In EUR thousand||2011||2010||Change|
|thereof Veregen® product revenue and royalties||2,050||1,529||34%|
|Other operating income||2,356||78||>200%|
|thereof 2% share of net sales of Eligard®||2,157||0||-|
|Cost of sales||-953||-781||22%|
|Selling, general and administrative expenses||-8,103||-9,399||-14%|
|Research and development expenses||-11,254||-13,494||-17%|
|Product sales from discontinued operations||27,828||47,398||-41%|
|Net result for the year||6,281||-17,869||-|
|Cash and cash equivalents as at Dec. 31||12,811||4,770||169%|
In 2012, Medigene expects revenue from continued operations to be greater than EUR 5 million. In addition, the company expects revenue from discontinued operations of EUR 5 million, relating to the transfer of the rights to Eligard® for non-EU countries. Higher investment in the further clinical development of RhuDex® is expected to lead to a loss on an EBITDA basis in the mid-single digit million euro range.
For 2013, Medigene anticipates growth in revenue from continued operations as a result of the expected expansion in the commercialization of Veregen®.
In the event that Medigene expends the product portfolio, the financial forecast will be adjusted accordingly.
Based on current business planning and scenarios developed on the basis of this planning, Medigene management expects the company's funding to be secured beyond the end of 2013.
Eligard® - transfer of rights for non-EU countries in Europe
Medigene expects the milestone payment of EUR 5 million for the transfer of the rights for European countries outside the EU in 2012. In addition, Medigene will continue to receive 2% royalties on net sales from Eligard® achieved by Astellas.
Veregen® - market launch in Spain and marketing authorization for numerous countries expected
The market launch of Veregen® in Spain is scheduled for the first half of 2012. On the basis of the regulatory decision at the beginning of March 2012 to grant marketing authorization of Veregen® for 17 additional European countries (Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Slovenia and Sweden), the relevant national marketing authorizations will be issued by the authorities in each country. Furthermore, Medigene anticipates positive decisions in 2012 regarding approval in selected countries outside the EU. Medigene intends to sign additional partnership agreements for marketing Veregen® at global level. For 2012, Medigene assumes a further increase in Veregen® sales revenue.
EndoTAG®-1 - activities for establishing development and marketing partnerships
Medigene aims to establish one or more partnerships with pharmaceutical or biotechnology companies for EndoTAG®-1. The company foresees the partner or partners taking over the drug candidate's further development and subsequent marketing.
RhuDex® - continuation of clinical development
Medigene expects the results of the current formulation study to be ready by mid-2012. Based on this, the company plans to continue the clinical development of RhuDex®. Medigene aims to out-license RhuDex® no later than once proof of concept has been provided.
AAVLP technology - preclinical studies for further validation
Additional preclinical studies will be conducted in 2012 in connection with Medigene's proprietary AAVLP vaccine technology.
A press telephone conference in German will be held today at 9:30 a.m. CET.
The analysts' telephone conference in English will be held today at 2:00 p.m. CET and will be webcast live. It will be possible to access the synchronized presentation slides and a recording via Medigene's website, www.medigene.com.
The complete Annual Report can be found online under http://www.medigene.com/media-investors/reports-presentations/
New Medigene website: Visit our new internet page at www.medigene.com!
This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene®, EndoTAG®, RhuDex® and Veregen® are registered trademarks of MediGene AG. Eligard® is a trademark of Tolmar Therapeutics, Inc. These trademarks may be owned or licensed in select locations only.
- End -
MediGene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered in Martinsried/Munich, Germany. Medigene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to have revenues from marketed products, which are distributed by partner companies. It has two drug candidates in clinical trials and is developing an innovative vaccine technology.
Julia Hofmann & Kerstin Langlotz
Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
To unsubscribe from the press release distribution list, please go to www.medigene.com/unsubscribe.