Conference call and webcast (in English) today, 12 May 2016, at 3:00 pm CEST (9:00 am EDT)
Martinsried/Munich, 12 May 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, today reports financial results and corporate updates for the first quarter of 2016.
Major events since the beginning of 2016:
Immunotherapies:
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Phase II of Phase I/II trial with DC vaccine for the treatment of acute myeloid leukaemia (AML) initiated following positive recommendation by DSMB
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Early IIT clinical data for DC vaccines presented at AACR by academic partner Oslo University
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DC patent portfolio strengthened
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Additional viral vector production capacities secured for clinical TCR studies
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Research collaboration started with University of Lausanne for TCRs
Company:
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Management change: CSO Prof Dolores Schendel appointed CEO/CSO, Dave Lemus takes over as COO
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Strengthened management team with appointment of three Senior Vice Presidents
Key figures in the first quarter of 2016:
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Increase in total revenue by 132% to €3,909 k (3M 2015: €1,686 k)
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Increase in R&D expenses for immunotherapies by 64% to €1,907 k (3M 2015: €1,166 k)
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EBITDA loss reduced by 54% to €939 k (3M 2015: €2,042 k)
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Cash and cash equivalents and time deposits of €46,310 k as at 31 March 2016 (31 December 2015: €46,759 k)
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Confirmation of financial guidance 2016
Prof. Dr Dolores Schendel, Chief Executive Officer of Medigene AG, comments: "In the first quarter of 2016, the clinical development of our immunotherapy programmes progressed further. We are making extensive efforts now towards putting into practice our first clinical studies with TCRs. As Medigene`s new CEO, I`m delighted about these important examples of progress."
Dave Lemus, Chief Operating Officer of Medigene AG, adds: "Medigene`s transformation into a leading immuno-oncology company begins increasingly to take shape. Accordingly, the planned increase in expenses for immunotherapy-driven research and development in the first quarter of 2016 evidences this change, and is enabled by the company`s positive financial condition."
Key figures in Q1 2016:
| IN € K | Q1 2016 | Q1 2015 | Change |
| Results of operations | |||
| Total revenue | 3,909 | 1,686 | 132% |
| Veregen revenue | 624 | 714 | -13% |
| Other operating income | 3,285 | 972 | >200% |
| thereof gain on sale of intangible assets, net (EndoTAG) | 2,365 | 0 | - |
| Gross profit | 3,594 | 1,418 | 153% |
| Selling and general administrative expenses | -2,312 | -1,740 | 33% |
| Research and development expenses | -2,395 | -1,932 | 24% |
| Operating result | -1,113 | -2,254 | -51% |
| Net profit/loss for the period | -1,387 | -3,672 | -62% |
| EBITDA | -939 | -2,042 | -54% |
| Earnings per share (€) | -0.07 | -0.26 | -73% |
| Personnel expenses | -2,452 | -1,758 | 39% |
| Cash flows | |||
| Net cash used in operating activities | -1,064 | -1,777 | -40% |
| Net cash provided by/used in investing activities | 626 | -53 | >-200% |
| Net cash used in financing activities | -11 | 0 | - |
| Balance sheet data as at 31 March 2016 and 31 December 2015 | |||
| Cash and cash equivalents and time deposits | 46,310 | 46,759 | -1% |
| Total assets | 110,095 | 113,531 | -3% |
| Current liabilities | 9,013 | 9,664 | -7% |
| Non-current liabilities | 12,970 | 13,879 | -7% |
| Shareholders` equity | 88,112 | 89,988 | -2% |
| Equity ratio (%) | 80 | 79 | 1% |
| Employees as at 31 March | 81 | 69 | 17% |
| FTE as at 31 March | 75 | 62 | 20% |
| Medigene share as at 31 March | |||
| Total number of shares outstanding | 19,688,202 | 13,956,417 | 41% |
The Company generates its revenue and other operating income from its non-core business. Total revenue of the Company increased by 132% to €3,909 k in the reporting period (3M 2015: €1,686 k) on account of extraordinary effects related to the sale of EndoTAG® agreed in December 2015.