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Medigene publishes annual report 2015: Cash increased substantially, financial guidance met

Conference call and webcast (in English) today at 3:00 pm CET (10:00 am EST)

Martinsried/Munich, 17 March 2016. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T-cell immunotherapies for the treatment of cancer, publishes its annual report for 2015 today.

Key figures in 2015:

  • Focussed investments in core activities: research and development expenses for immunotherapies increased by 95%
  • EBITDA forecast met
  • Cash and cash equivalents  increased to EUR 46.8 m

Major events in 2015:

  • Capital increase with gross proceeds of EUR 46.4 m successfully concluded
  • Phase I/II DC vaccine trial started
  • Patent position for immunotherapies strengthened
  • EndoTAG® sold to SynCore
  • Catherex sold to Amgen. Milestone payment received.
  • Significant management changes

Peter Llewellyn-Davies, CFO of Medigene AG, comments on the company's financial performance in 2015: "We can look back on yet another successful year. Our financial guidance was met. The completed capital increase and the sale of EndoTAG® and Catherex have put Medigene in a very sound financial position. Medigene is now well-positioned for the continued increased investments in the ongoing and future clinical development of our immunotherapy programmes."

Prof. Dolores Schendel, CEO and CSO of Medigene AG, adds: "In 2015 we achieved significant operational progress, successfully completed the transformation into a clinical-stage immunotherapy company, and positioned Medigene in the field of immuno-oncology. I would like to express my heartfelt thanks to my outgoing management colleagues Dr. Frank Mathias and Peter Llewellyn-Davies for their valuable contribution during Medigene's repositioning process. Our COO Dave Lemus, who will now also assume the responsibilities of the Chief Financial Officer and I, with the support of our strong team are looking forward to further advancing the clinical development of our innovative programmes. Besides our DC vaccines, our TCR technology will also be at the forefront, with three clinical studies to start during the period between 2016 and 2018."

Financial results 2015:

Consolidated income statement (abbreviated)
IN € K 2015 2014 CHANGE
Revenue (Veregen®) 3,101 5,195 -40%
thereof royalties 2,549 2,352 8%
thereof revenue from product sales 467 2,118 -78%
thereof milestone payments 85 725 -88%
Other operating income 3,707 8,589 -57%
thereof R&D payments from partners 1,123 1,936 -42%
thereof R&D milestone payments 0 2,699 -
thereof other revenue 2,584 3,954 -35%
Total revenue 6,808 13,784 -51%
Cost of sales -1,103 -2,086 -47%
Gross profit 5,705 11,698 -51%
Selling and general administrative expenses -7,615 -7,081 8%
Research and development expenses -8,529 -7,498 14%
Operating result -10,439 -2,881 > 200%
Net profit/loss for the year -12,999 -5,757 126%
EBITDA -9,495 -2,071 >200 %

Medigene generated revenues from its non-core business, i.e. from out-licensed/sold drugs. These revenues decreased in 2015 as planned to €6,808 K (2014: €13,784 K) compared to last year, especially as a consequence of one-off revenues and lower cost reimbursements for research and development. Revenue from license fees (royalties) for Veregen® rose by 8% to €2,549 K (2014: €2,352 K).

Research and development costs increased in 2015 according to plan, by 14% to €8,529 K (2014: €7,498 K). The increase is mainly due to the higher expenses for preclinical and clinical trials for Medigene's immunotherapies, which increased significantly as planned in 2015 by 95% to €5,534 K (2014: €2,832 K). This increase was partially balanced out by lower development expenses for other, outlicensed products.

Furthermore, the EBITDA loss increased in 2015 to €-9,495 K (2014: €-2,071 K), as expected. The increase is mainly due to the decreased income from non-core business and higher research and development costs for Medigene's immunotherapy programmes compared to last year.

Medigene also improved its cash, cash equivalents and time deposits to €46,759 K (2014: €14,976 K). This increase is a result of the successfully completed capital increase in July 2015.

At the end of December 2015, Medigene announced that Amgen Inc., USA, had acquired Catherex, Inc. As the largest shareholder of Catherex, Medigene, Inc., USA, is entitled to approximately 40% of all payments to be made by Amgen in the course of the acquisition. The former shareholders of Catherex receive an upfront payment from Amgen of US$10.5 m and are entitled to further payments when certain regulatory and sales-based milestones are reached for Amgen's drug ImlygicTM. In addition, they are entitled to payments based on sales of ImlygicTM until the end of 2020. In February 2016 Medigene, Inc. received its share of the agreed upfront payment (execution fee) less transaction costs and liabilities and received a milestone payment of US$1.2 m as final development/regulatory milestone payment. The gain on sale was recognised in 2015 on a net basis under "share of result/disposal of associates".

Medigene met its improved EBITDA forecast as revised in its 9-Months Report for 2015. According to the forecast, the company anticipated an EBITDA loss of €9 - 10 m, and research and development expenses for its immunotherapy programmes of €6 - 7 m, which were slightly lower due to reduced expenses for external service providers. Total revenue from Veregen® was within the projected €3 - 4 m.

Financial forecast 2016:

Medigene is planning to expand its clinical development programs, and therefore expects a further significant increase in research and development costs for immunotherapies in the range of € 9 - 11 million in 2016 (2015: € 5.5 million). The 2016 EBITDA loss is expected to reach €10 - 12 million (2015: € 9.5 million).

The company expects revenues for Veregen® of € 3 - 4 million (2015: € 3.1 million) for the year 2016, as well as steady/increasing total revenues (2015: € 6.8 million).

The detailed interactive annual report 2015 is available online at: 
annualreport2015.medigene.com
Press and analysts' conference call: A press and analysts conference call (in English) will be held today at 3:00pm CET / 10:00am EST (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. The company is developing highly innovative, complementary treatment platforms to target various types and stages of cancer with candidates in clinical and pre-clinical development. Medigene concentrates on the development of personalized T cell-based immunotherapies.

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® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Contact Medigene
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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