News

Medigene publishes results for the first three months of 2015

Press and analysts conference call with webcast today, 12 May 2015, 3 p.m. (CEST)

Key figures in the first quarter of 2015:

  • Royalties from Veregen® increased by 39%  
  • Total revenue decreased by 31% due to one-off milestone payment in previous year 
  • R&D expenses for immunotherapy programmes significantly increased
  • EBITDA-loss increased by 41% as planned  
  • Financial guidance 2015 confirmed

Mayor events since the beginning of 2015:

  • Phase I/II trial with DC vaccines in acute myeloid leukemia (AML) initiated
  • Licenced EU patent for the process to manufacture DC vaccines granted
  • Early clinical data on DC vaccines presented at AACR Annual Meeting, USA, by academic partner Oslo University
  • Publication on TCRs in "Nature Biotechnology"
  • Positive decision on marketing approval for Veregen® granted in eight further European countries

Martinsried/Munich, 12 May 2015. Medigene AG (MDG1, Frankfurt, Prime Standard) today published its final financial results for the first three months of 2015.

In the first three months of 2015, Medigene's royalties from the drug Veregen® increased by 39% to €589 k as a result of higher market sales (Q1 2014: €423 k). Mainly due to a one-off milestone payment for Veregen® in the first quarter of 2014, Medigene's total revenue fell in the reporting period to €1,686 k (Q1 2014: €2,430 k).

As planned, research and development expenses increased by 21% in the first quarter of 2015 to €1,932 k (Q1 2014: €1,596 k). The increase in these costs is mainly due to higher expenses for preclinical and clinical trials for Medigene's immunotherapies which increased significantly to €1,166 k in the first three months of 2015 (Q1 2014: €145 k). The development expenses incurred for EndoTAG®-1 decreased in the reporting period to €631 k (Q1 2014: €691 k). These development expenses are reimbursed by the partner SynCore and recorded in other operating income as R&D payments from partners.

As planned, the EBITDA loss rose in the first quarter of 2015 to €2,042 k (Q1 2014: €1,452 k). The net loss increased to €3,672 k (Q1 2014: €2,044 k). The difference to the EBITDA loss is primarily attributable to foreign exchange losses from non-cash revaluation of €1,531 k.

Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, commented: "The positive newsflow of the first three months of 2015 documents the numerous activities and achievements in our immunotherapies business. Since the start of the year we have begun a clinical trial with our DC vaccines, an important patent on the manufacturing process was granted, and positive clinical data were presented by our academic partner at a leading medical conference. Regarding our TCR technology, we are progressing in our preparations for clinical development, whereas a publication in 'Nature Biotechnology' validates the scientific foundation for future clinical trials. This motivates us to further concentrate our resources on our immunotherapies."

CONSOLIDATED INCOME STATEMENT (ABBREVIATED)

IN € K Q1 2015
unaudited
Q1 2014
unaudited
Change
Revenue Veregen® 714 1,329 -46%
thereof royalties 589 423 39%
thereof revenue from product sales  125 226 -45%
thereof milestone payments from product sales  0 680 -
Other operating income 972 1,101 -12%
Total revenue 1,686 2,430 -31%
Cost of sales -268 -267 0%
Gross profit 1,418 2,163 -34%
Selling and general administrative expenses -1,740 -2,210 -21%
Research and development expenses -1,932 -1,596 21%
Operating result -2,254 -1,643 37%
Net profit/loss for the period -3,672 -2,044 80%
EBITDA profit/loss -2,042 -1,452 41%

Financial forecast for 2015:

Medigene confirms its financial guidance for 2015 and expects a double-digit percentage increase in Veregen® royalties (2014: €2.4 m) based on the assumptions made by the Company's partners. In spite of reduced milestone payments, total revenue for Veregen® is projected to remain stable in 2015 (2014: €5.2 m). Furthermore, Medigene expects to generate other operating income consisting mainly of reimbursements of development expenses for EndoTAG®-1 by SynCore and of stable non-cash income from Cowen Healthcare Royalty Partners L.P. The Company plans to significantly increase its research and development expenses for its immunotherapy programmes. In 2015, these expenses are planned to amount to €7 - 9 m (2014: €2.9 m). Mainly due to these increased investments in Medigene's innovations the EBITDA loss is anticipated to increase to €11 - 13 m in 2015 (2014: €2.1 m).

Based on the current business planning, management expects that Medigene will be financed into the second quarter of 2016 without considering any potential licencing partner agreements or any measures to raise capital. Financing beyond the second quarter of 2016 will require further external financial resources and the Executive Management Board currently assumes that these funds can be obtained. The Company can obtain these funds from, for example, additional partnerships with pharmaceutical companies or capital measures.

The detailed three 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 / 10:00 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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