Medigene reports positive 2011 fiscal year results
(Thomson Reuters ONE) -
MediGene AG /
Medigene reports positive 2011 fiscal year results
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The issuer is solely responsible for the content of this announcement.
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.
Expenses
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).
Key figures:
In EUR thousand 2011 2010 Change
-------------------------------------------------------------------------------
Product sales 2,300 2,214 4%
thereof Veregen(®) product revenue and 2,050 1,529 34%
royalties
Other operating income 2,356 78 >200%
thereof 2% share of net sales of Eligard(®) 2,157 0 -
Total revenue 4,656 2,292 103%
Cost of sales -953 -781 22%
Gross profit 3,703 1,511 145%
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 -
EBITDA 11,180 -12,756 -
Cash and cash equivalents as at Dec. 31 12,811 4,770 169%
Outlook:
Financial guidance:
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.
Press conference:
A press telephone conference in German will be held today at 9:30 a.m. CET.
Analysts' conference:
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 www.medigene.com/reports
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.
Contact
Julia Hofmann & Kerstin Langlotz
Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20
Email: investor(at)medigene.com
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press release as pdf:
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Source: MediGene AG via Thomson Reuters ONE
[HUG#1596658]
Unternehmensinformation / Kurzprofil:
Datum: 23.03.2012 - 07:30 Uhr
Sprache: Deutsch
News-ID 127786
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contact information:
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