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Medigene AG: Medigene publishes results for the first six months of 2015

Press release

Medigene publishes results for the
first six months of 2015

Successful fundraising enables acceleration of R&D activities in immunotherapies

Major events since the beginning of 2015:

  • Gross proceeds of €46.4 m raised from the successful capital increase to finance immunotherapy programmes
  • Phase I/II trial initiated with DC vaccine for the treatment of acute myeloid leukaemia (AML)
  • Progress in phase I/II DC trial triggered milestone payment
  • Licensed patent for the manufacturing process of DC vaccines granted in Europe and prolonged in the US
  • Early clinical data on DC vaccines presented at the AACR Annual Meeting 2015, USA, by academic partner Oslo University
  • Publication on TCRs in "Nature Biotechnology"

Key figures in the first half of 2015:

  • Increase in research and development expenses by 21% to €4.1 m (6M 2014: €3.4 m)

 

  • Significant investments in the area of immunotherapy programmes of €2.6 m (6M 2014: €0.7 m)

 

  • Scheduled increase in EBITDA loss to €4.3 m (6M 2014: €1.6 m)
  • Increase in royalties from Veregen®
  •  by 16% to €1.2 m (6M 2014: €1.0 m)
  • Decrease in selling and general administrative expenses by 11% to €3.5 m (6M 2014: €3.9 m)

Martinsried/Munich, 6 August 2015. Medigene AG (MDG1, Frankfurt, Prime Standard) today published its results for the first six months of 2015. In 2015, Medigene achieved significant operational progress and consequently invested in the development of its cancer-immunotherapy programmes.

As planned, research and development expenses increased by 21% to €4,117 k in the first half of 2015 (6M 2014: €3,408 k). The increase in these expenses is mainly due to the increase in expenses for preclinical and clinical trials for Medigene's immunotherapies, which rose significantly to €2,582 k in the first six months of 2015 (6M 2014: €663 k).

In contrast, selling and general administrative expenses were decreased by 11% to €3,476 k in the first half of 2015 (6M 2014: €3,906 k).

Outside of its core business, Medigene generated revenue from the partnered drug Veregen® as well as other operating income from the out-licensed drug candidates EndoTAG®-1 and RhuDex®. Due to one-off payments in the previous-year period for Veregen® and RhuDex® and lower reimbursements for EndoTAG®-1 costs, Medigene's total revenue decreased in the reporting period to €3,372 k (6M 2014: €6,093 k).

As planned, the EBITDA loss increased to €-4,251 k in the first half of 2015 (6M 2014: €-1,629 k) as a result of the higher investments in the immunotherapy programmes and lower revenues from the non-core business segment.

Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, commented: "In the first half of 2015, Medigene has shown strong performance with significant achievements in our core business, cancer immunotherapy. We have advanced the clinical development of our DC vaccine programme. The support from leading international investors allows us to accelerate and further broaden our research and development activities, especially for the TCR platform. Based on our successful funding of over €46 million, we can now comprehensively implement our cancer immunotherapy strategy."

CONSOLIDATED INCOME STATEMENT (ABBREVIATED)

IN € k 6M 2015

 
6M 2014

 
CHANGE
Revenue Veregen® 1,363 2,555 -47%
thereof royalties 1,182 1,018 16%
thereof revenue from product sales  156 837 -81%
thereof milestone payments  25 700 -96%
Other operating income 2,009 3,538 -43%
thereof R&D payments from partners 712 1,018 -30%
thereof R&D milestone payments  0 728 -
thereof other revenue 1,297 1,792 -28%
Total revenue 3,372 6,093 -45%
Cost of sales -471 -799 -41%
Gross profit 2,901 5,294 -45%
Selling and general administrative expenses -3,476 -3,906 -11%
Research and development expenses -4,117 -3,408 21%
Operating result -4,692 -2,020 132%
Net profit/loss for the period -6,113 -2,841 115%
EBITDA -4,251 -1,629 161%

Financial forecast for 2015:
Medigene confirms its financial forecast for the fiscal year 2015. According to this, the Company plans to significantly increase its research and development expenses for its immunotherapy programmes to €7 - €9 m (2014: €2.9 m) and anticipates an EBITDA loss of €11 - €13 m (2014: €2.1 m). Outside of its core business and based on the assumptions made by the partners, Medigene expects a double-digit percentage increase in Veregen® royalties and stable total revenue for Veregen® (2014: €5.2 m).  Furthermore, Medigene expects to generate other operating income consisting mainly of non-cash income from Cowen at a level comparable to the previous year and of reimbursements of development costs for EndoTAG®-1 from SynCore. By successfully concluding the capital increase at the beginning of July 2015, Medigene has extended the Company's cash reach significantly. Based on the current business planning, management expects that the Company will be financed at least until the second half of 2019.

The detailed six months report 2015 is available online at:
www.medigene.com/media-investors

Press and analysts' conference call: A press and analysts conference call (in English) will be held today at 3:00 p.m. CEST / 9:00 a.m. EDT (USA) 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 a focus on hematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partner companies. Medigene has advanced drug candidates which are licensed to partners and additional candidates in clinical development. The company is developing highly innovative treatment platforms concentrating on cancer and autoimmune diseases. 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®, Veregen®, EndoTAG® and RhuDex® are registered trademarks of Medigene AG. Medigene ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. Trianta ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. These trademarks may be owned or licensed in select locations only.

Contact Medigene
Julia Hofmann, Anja Clausnitzer
Tel.: +49 - 89 - 20 00 33 - 33 01

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