Medigene reports financial results for the first nine months of 2013
November 08 2013 - 12:30AM
Medigene AG / Medigene reports financial results for the first
nine months of 2013 . Ad hoc announcement according to § 15 WpHG.
Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.
Press and
analysts conference call with webcast today, 8 November 2013, 10:00
am (CET)
- Further increase in revenue
with stable operating costs
- Veregen® in-market sales
growth of 40%
- Progress achieved in
development projects
Martinsried/Munich, 8 November 2013. In the first
nine months of 2013, Medigene AG (MDG1, Frankfurt, Prime Standard)
reported an increase in revenue with stable operating costs.
Based on significant growth of
in-market sales (+ 40%), revenue from royalties for
Veregen® increased by
39% to EUR 1.9 million (9M 2012: EUR 1.4 million).
Veregen® revenue
increased by 14% to EUR 2.8 million in the first nine months of
2013 (9M 2012: EUR 2.5 million). Total revenue amounted to EUR 5.1
million compared to EUR 4.8 million in the same period of the
previous year, when Medigene received a one-off compensation
payment amounting to EUR 0.4 million. Excluding this one-time
effect in the previous year, total revenue in the first nine months
of 2013 increased by 17%.
With stable operating expenses of
EUR 10.7 million (9M 2012: EUR 10.9 million), Medigene's EBITDA
result of EUR -6.1 million (9M 2012: EUR -1.3 million) was in line
with the company's expectations. Excluding the preceding year's
one-time effects (a EUR 5 million milestone payment from
discontinued operations and a compensation payment of EUR 0.4
million), Medigene's EBITDA result improved by 8% compared to last
year's reporting period.
The net result for the first nine
months of 2013 amounted to EUR -7.7 million (9M 2012: EUR -0.2
million). The previous year's result was positively influenced by
the aforementioned one-time effects and by the revaluation of an
investment and without these, EUR -7.8 million was posted (9M
2012).
Cash and cash equivalents as at 30
September 2013 totalled EUR 11.7 million. Medigene expects cash
reach at least until early 2015.
Highlights
in the first nine months of 2013
- Revenue from royalties for Veregen®
increased by 39%; further market launches, approvals and marketing
partnerships
- Global partnership agreement for
EndoTAG®-1 concluded;
phase III clinical trial funded
- Preparation of phase III trial for
EndoTAG®-1 and phase
II trial for RhuDex®
- Share consolidation successfully concluded with
4:1 capital reduction
Peter
Llewellyn-Davies, Chief Financial Officer of Medigene AG,
comments: "In the first nine months of 2013, we realised positive
sales and expenses developments, as well as making important
progress with our drug development projects. It remains our
objective to continue developing and strengthening the product
pipeline. Through the successfully completed capital reduction, we
have increased Medigene's transaction ability and therefore
provided an important foundation for exploring strategic
options."
Consolidated income
statement (abbreviated)
In EUR k |
9M 2013 |
9M 2012 |
Change |
Revenue Veregen® |
2,837 |
2,483 |
14% |
thereof
royalties |
1,889 |
1,358 |
39% |
thereof revenue
from supply chain |
735 |
517 |
42% |
thereof milestone
payments |
213 |
608 |
-65% |
Other operating income |
2,284 |
2,276 |
0% |
Total revenue |
5,121 |
4,759 |
8% |
Total revenue before one-time
effect |
5,121 |
4,369 |
17% |
Cost of sales |
-1,055 |
-775 |
36% |
Gross profit |
4,066 |
3,984 |
2% |
Selling, general and administrative
expenses |
-5,616 |
-5,728 |
-2% |
Research and development
expenses |
-5,119 |
-5,169 |
-1% |
Operating result |
-6,669 |
-6,913 |
-4% |
Income from revaluation of an
investment |
0 |
2,213 |
- |
Net result for the
period |
-7,728 |
-167 |
>200% |
Net result for the period before
one-time effects |
-7,728 |
-7,770 |
-1% |
EBITDA |
-6,106 |
-1,269 |
>200% |
EBITDA before one-time
effects |
-6,106 |
-6,659 |
-8% |
Guidance
Financial guidance 2013
Medigene anticipates the financial
results 2013 to be within the announced guidance. The projected
total revenue includes Veregen® revenue,
income from the partnership for EndoTAG®-1 with
SynCore, and non-cash income from the Eligard® deal
concluded in 2012. Total revenue 2013 is expected to be at the
lower end of the guided range of EUR 8 - 9 million due to a slight
shift in market launches of Veregen® in a number
of countries. The respective Veregen® revenues will
be recaptured in 2014. The loss on an EBITDA basis is expected to
be in the middle of the guided range of EUR 8 - 10 million.
Medigene's management anticipates that the funding of the company
is secured until at least the beginning of 2015.
Veregen®
Medigene expects further market
approvals and market launches of Veregen® in several
additional countries in the future. Marketing authorisation
applications for nine remaining European countries participating in
the mutual recognition procedure are scheduled for 2014. For the
global commercialisation of Veregen®, Medigene
plans to enter into additional partnership agreements. The company
anticipates continued significant double-digit growth of
Veregen® in-market
sales.
EndoTAG®-1
Together with its partner SynCore,
Medigene plans a pivotal global phase III trial of
EndoTAG®-1 in
triple-negative breast cancer (TNBC), with the aim to achieve
market approvals worldwide. As part of the global development and
marketing partnership, SynCore has undertaken to finance the phase
III trial in full. This trial is expected to start in the second
half of 2014.
RhuDex®
Medigene plans to conduct a phase
II clinical trial in primary biliary cirrhosis (PBC) to confirm the
mode of action of RhuDex® in autoimmune
diseases. Subject to the successful completion of the preparatory
work and trial approval by the regulatory authorities, the start of
the PBC phase II trial is scheduled for the first half of 2014.
Medigene is looking for a partner to co-finance the study.
AAVLP technology
The preclinical long-term
protection study in cooperation with the Pennsylvania State
University aims to demonstrate long-term protection against
infection with various HPV types will be continued. The AAVLP
technology is available for partnerships and licensing.
The detailed
nine-month report 2013 is available online at
http://www.medigene.com/media-investors/reports-presentations/financial-reports
Press and
analysts' conference call: A press and analysts conference
call (in English) will be held today at 10:00 a.m. CET and will be
webcast live. The synchronized presentation slides and a recording
can be accessed via Medigene's website, www.medigene.com
Medigene
AG is a publicly listed (Frankfurt: MDG1, prime standard)
biotechnology company headquartered in Martinsried near 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 a marketed
product, Veregen®, which is
distributed by partner companies. It has two drug candidates in
clinical trials, EndoTAG®-1 and
RhuDex®; and is
developing an innovative vaccine technology. Further information 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®, Veregen®, EndoTAG® and RhuDex® are registered trademarks of
Medigene AG. These trademarks may be owned or licensed in select
locations only.
Contact
Julia Hofmann, Claudia Burmester
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com
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