Press and analysts conference call with webcast today, 27 March 2014, 3 p.m. (CET)
- Veregen® in-market sales growth of 40%
- Total revenue increased by 21%
- Net loss from continued operations reduced by 31%
- Strategic progress achieved through acquisition of Trianta Immunotherapies
- Partnership agreements for EndoTAG®-1 and RhuDex®
- Further improvement in sales and result expected for 2014
Martinsried/Munich, 27 March 2014. The biotechnology company Medigene AG (MDG1, Frankfurt, Prime Standard) today published its 2013 Annual Report as well as its outlook for 2014. In 2013, Medigene increased its total revenue by 21% and reduced net loss for the year from continued operations by 31%. For the 2014 financial year, Medigene expects a further improvement in revenue development and a significant reduction in its EBITDA loss.
Medigene achieved an increase in revenue generated with the drug Veregen® of 24% to EUR 4.2 m in 2013 (2012: EUR 3.4 m). Royalties from Veregen®rose by 38% to EUR 2.6 m (2012: EUR 1.9 m). In addition, Medigene's other operating income was up 17% to EUR 3.4 m (2012: EUR 2.9 m). Total revenue improved by 21% in 2013 to reach EUR 7.6 m (2012: EUR 6.3 m).
With stable operating expenses overall, Medigene was able to reduce its EBITDA loss from continued operations by 12% to EUR 8.3 m (2012: EUR 9.4 m) and the net loss from continued operations by 31% to EUR 10.3 m (2012: EUR 14.9 m). Cash and cash equivalents totalled EUR 10.2 m as at 31 December 2013 (31 December 2012: EUR 20.1 m).
For 2013, Medigene had guided total revenue of around EUR 8 m and an EBITDA loss of approximately EUR 9 m (9-month report 2013).
Dr. Frank Mathias, CEO of Medigene AG, comments: "Medigene has changed substantially over the last twelve months. Through the transformative acquisition of Trianta and with partnerships secured for EndoTAG®-1 and RhuDex® we have shaped new prospects for Medigene focused on cutting-edge cancer immunotherapies. Our goal is to build a franchise in hematological malignancies with our own development programs and to offer further development options in solid tumours to selected partners. This approach provides Medigene with a clear strategic path forward underpinned by a wide range of exciting development opportunities."
Peter Llewellyn-Davies, CFO of Medigene AG, comments: "We have consistently implemented our strategy by improving cost structures and strengthening our pipeline to optimally position ourselves for long-term growth. The improvements in revenue and EBITDA achieved in 2013 will be continued in 2014, further reducing the EBITDA loss significantly. At the same time, we are investing in our newly acquired immunotherapy technology and products, for which we are driving forward the clinical and preclinical development. This will open up new partnership and financing options as well as further strategic opportunities."
Prof. Dr. Dolores Schendel, Managing Director of Trianta GmbH and Executive Board member responsible for research and development at Medigene AG, explains: "Our three T cell-focussed immunotherapy platforms have development potential to enable the treatment of a range of cancers in various stages of disease. In the ongoing development, Medigene/Trianta will be concentrating on haematology across all platforms with the aim of making personalised and highly effective treatment options available spanning the oncological blood disease spectrum. We will take important steps in 2014, especially the start of a further clinical trial in leukaemia, to bring our therapies to seriously ill patients as fast as possible."
|consolidated income statement (abbreviated)|
|In € k||2013||2012||change|
|thereof revenue from supply chain||1,326||896||48%|
|thereof milestone payments||298||610||-51%|
|Other operating income||3,383||2,900||17%|
|Cost of sales||-1,735||-1,250||39%|
|Selling, general and administrative expenses||-8,273||-7,909||5%|
|Research and development expenses||-6,605||-7,399||-11%|
|Other expenses (deconsolidation)||0||-6,166||-|
|Income from revaluation of investment||0||2,220||-|
|Result from discontinued operations||0||5,018||-|
|Net result for the year||-10,282||-9,859||4%|
|Net result for the year from continued operations||-10,282||-14,877||-31%|
|EBITDA from continued operations||-8,270||-9,427||-12%|
Financial forecast for 2014
Medigene expects a double-digit percentage increase in total revenue in 2014. Thereof revenue from Veregen® is likely to amount to EUR 5 - 6 m. In addition, Medigene expects to generate revenue consisting mainly of reimbursements of development costs for EndoTAG®-1 from SynCore, of non-cash payments from a transaction with Medigene's former drug Eligard as well as milestone payments and pro rata upfront payments from partnerships. The EBITDA loss in 2014 is likely to be reduced to EUR 4 - 6 m.
According to the current business assumptions, Medigene expects to be financed at least until the second quarter of 2015. Medigene has various options for financing beyond this period including grants, additional partnerships with pharmaceutical or biotechnology companies or capital measures.
Medigene expects the market launch of Veregen® in 2014 in numerous other countries, especially in Europe. The Company is planning to file for approval in a further seven to nine European countries under the mutual recognition procedure in the second half of 2014. Medigene is planning to conclude further partnerships for the international commercialisation of Veregen®. Medigene expects a double-digit percentage increase in Veregen® sales in 2014.
SynCore, is planning a pivotal international phase III trial of EndoTAG®-1 in the indication triple-negative breast cancer (TNBC). SynCore will bear the costs of the trial and is planning to start the study end of 2014.
In March 2014, Medigene signed a licence agreement with Falk Pharma for RhuDex®. Falk Pharma is now preparing clinical development for RhuDex® in the indication primary biliary cirrhosis. Under the terms of the licence agreement, Falk Pharma obtained the rights to RhuDex® in hepatology and gastroenterology and will bear all development and marketing costs for RhuDex® in these therapeutic areas.
The current investigator initiated trials (IITs) being conducted at the University Hospital in Oslo (phase II trial in prostate cancer) and at the University Hospital in Munich (phase I/II trial in AML) will continue. Medigene plans to initiate a further clinical study in AML (acute myeloid leukaemia) in 2014.
TCR-modified T cells
The development of a GMP-compliant manufacturing process for the adoptive T cell therapy using TCR-modified T cells will continue. Clinical development of the first product candidates is in preparation and the first preparatory talks with the authorities have already taken place.
Preclinical development of the anti-TCR monoclonal antibodies (TABs) continues with the aim of achieving proof of principle.
The current preclinical development in cooperation with Pennsylvania State University aims to demonstrate long-term protection against infection from various types of HPV. AAVLP technology is available for partnerships and for out licensing.
The detailed Annual Report is available at www.medigene.com/reports
Press and analysts' conference call: A press and analysts conference call (in English) will be held today at 3:00 p.m. CET and will be webcast live. Please access the synchronized presentation slides and a recording 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 concentrates on the development of personalized T cell immunotherapies with focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, Veregen®, which is distributed by commercial partners companies. Medigene has various drug candidates in clinical development and it is developing highly innovative treatment platforms. Medigene's wholly-owned subsidiary, Trianta, is developing next generation antigen-tailored dendritic cell (DC) vaccines, T cell receptor (TCR)-based adoptive cell therapy and T cell-targeted antibodies (TABs). For more information, please visit 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® and Veregen®are registered trademarks of Medigene AG. Polyphenon E® is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.
Julia Hofmann, Claudia Burmester
Tel.: +49 - 89 - 20 00 33 - 33 01
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