- Conference call and webcast (in English) today at 3:00pm CET (9:00am EST) -
Key figures for the first nine months of 2015:
• Guidance adjusted with improved EBITDA • Increase in R&D expenses for immunotherapies by over 150% to EUR 3.9 m (9M 2014: EUR 1.6 m) • Cash and cash equivalents increased to EUR 50.8 m from successful capital measure
Major events since the beginning of 2015:
• Phase I/II trial initiated with DC vaccine for the treatment of acute myeloid leukaemia (AML) • Capital increase successfully concluded with gross proceeds of EUR 46.4 m to finance the immunotherapy programs • Progress in phase I/II DC trial triggered milestone payment • Licensed patent for the process to manufacture DC vaccines granted in Europe and prolonged in the US • Early clinical data on DC vaccines presented at the AACR Congress, USA, by academic partner Oslo University • Publication on TCRs in “Nature Biotechnology”
Martinsried/Munich, 12 November 2015. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immunotherapy company focussing on the development of personalised T-cell therapy platforms for the treatment of cancer, today publishes its nine-month report for 2015.
Dr Frank Mathias, CEO of Medigene AG: “In the first nine months of 2015, we have made significant operational progress and consistently invested in the development of our cancer immunotherapy programmes. Above all, we have continued to work towards the transformation of our company into a clinical stage innovative immunotherapy company. The start of our own phase I/II study with dendritic cell (DC) vaccines for the treatment of acute myeloid leukaemia (AML) marked an important step in strengthening our immunotherapy pipeline. At the beginning of the year, our academic partners presented positive early clinical data for this therapy approach and further evidence will be delivered at the upcoming ASH Conference in the USA early December. Alongside our DC platform, we also intend to launch our clinical T-cell receptor (TCR) programme. We have laid the necessary groundwork through our research advances, preclinical development and regulatory preparations, as well as by building up our in-house immune monitoring facility and by further extending our infrastructure.”
Peter Llewellyn-Davies, CFO of Medigene AG: “The capital measure we successfully carried out this year generated gross proceeds of EUR 46.4 million. As a result, we are in a sound financial position and can make larger investments in our innovative immunotherapy platforms in the coming years, enabling us to drive forward our progress in this field. Over the first nine months of 2015, we have met all our operational objectives with continued cost discipline; our total spending was lower than planned, despite a considerable increase in our research and development costs. For this reason, we are able to announce with this report an improvement in our guidance for EBITDA in 2015.”
Prof. Dr Dolores Schendel, CSO of Medigene AG: “For our TCR technology, we are planning to start up to three clinical trials and to develop up to 10 TCR lead candidates in the next years. Preparations have begun for the start of the first study, a clinical investigator-initiated phase I trial with Medigene’s involvement, which is scheduled to begin in the first half of 2016, subject to public grant funding. Additionally, Medigene is planning its own TCR studies in the second half of 2017 and 2018, which will further strengthen our position as an innovative immunotherapy player.”
CONSOLIDATED INCOME STATEMENT (ABBREVIATED)
| IN € K | 9M 2015
| 9M 2014
| CHANGE |
| Revenue Veregen® | 2,376 | 3,672 | -35% |
| thereof royalties | 1,895 | 1,747 | 8% |
| thereof revenue from product sales | 426 | 1,200 | -65% |
| thereof milestone payments | 55 | 725 | -92% |
| Other operating income | 2,950 | 4,704 | -37% |
| thereof R&D payments from partners | 1,010 | 1,486 | -32% |
| thereof R&D milestone payments | 0 | 742 | - |
| thereof other revenue | 1,940 | 2,476 | -22% |
| Total revenue | 5,326 | 8,376 | -36% |
| Cost of sales | -862 | -1,212 | -29% |
| Gross profit | 4,464 | 7,164 | -38% |
| Selling and general administrative expenses | -5,517 | -5,648 | -2% |
| Research and development expenses | -6,214 | -5,383 | 15% |
| thereof immunotherapies | -3,915 | -1,560 | 151% |
| Operating result | -7,267 | -3,867 | 88% |
| Net profit/loss for the period | -10,554 | -5,644 | 87% |
| EBITDA | -6,581 | -3,269 | 101% |
Medigene generated revenue from out-licensed drugs not belonging to its core business. Due to one-off revenue in the previous-year period and a decrease in the reimbursement of research and development costs, Medigene’s total revenue decreased in the reporting period to €5,326 k (9M 2014: €8,376 k). Revenue from royalties for the drug Veregen® increased by 8% to €1,895 k (9M 2014: €1,747 k).
Moreover, research and development (“R&D”) expenses increased by 15% to €6,214 k in the first nine months of 2015 (9M 2014: €5,383 k). The increase in these expenses is mainly due to the planned increase in expenses for preclinical and clinical trials for Medigene’s immunotherapies, which increased significantly by 151% to €3,915 k in the first nine months of 2015 (9M 2014: €1,560 k). This increase was partially offset by the decrease in development expenses for other, out-licensed products.
Furthermore, the EBITDA loss increased lower than anticipated to €-6,581 k in the first nine months of 2015 (9M 2014: €-3,269 k). The increase is primarily due to lower revenue from non-core business and higher research and development expenses for Medigene’s immunotherapy programmes.
Cash and cash equivalents amounted to €50,768 k as at the reporting date (2014: €14,976 k). The increase is due to the capital measure that was successfully concluded in July 2015 which generated net proceeds of €43,706 k.
Revised guidance 2015
Medigene has improved its EBITDA forecast for the entire fiscal year 2015. According to the current forecast, the Company plans research and development expenses for its immunotherapy programmes of €6 - 7 m (previous guidance: €7 - 9 m) due to more favourable costs for external service providers in particular and anticipates an EBITDA loss of €9 - 10 m (previous forecast: €11 - 13 m).
Outside of its non-core business, Medigene currently expects lower revenue for Veregen® than previously forecasted. Based on the current assumptions of the partners, in spite of growing royalties, Medigene estimates total revenue from Veregen® of €3 - 4 m (previous guidance: approximately €5 m) due to the decrease in milestone payments and product sales, some of which will now not occur until 2016. Furthermore, Medigene will generate other operating income consisting mainly of reimbursements of development costs for EndoTAG®-1 by SynCore and non-cash income from Cowen, the latter at a level comparable to the previous year.
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 until the second half of 2019.
The detailed nine months report 2015 is available online at:
http://www.medigene.com/media-investors
Press and analysts’ conference call: A press and analysts conference call (in English) will be held today at 3:00pm CET / 9:00am 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
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