On August 5, 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, reported financial results and corporate updates for the first six months of 2016 (Press release, MediGene, AUG 4, 2016, View Source [SID:1234514267]).
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Major events since the beginning of 2016:
Immunotherapies:
Phase II of Phase I/II trial with DC vaccine for the treatment of acute myeloid leukaemia (AML) initiated following positive recommendation by DSMB
Collaboration started with Max Delbrück Center and The Charité in Berlin for Germany’s first investigator-initiated clinical TCR trial
DC platform and TCR platform strengthened by new patents
Additional viral vector production capacities secured for clinical TCR trials
Company:
Expansion of management team
Capital increase by contribution in kind to fund milestone payment for the beginning of Phase II of Medigene’s Phase I/II trial with DC vaccines
Key figures in the first half of 2016:
R&D expenses increased by 23% to €5,079 k (6M 2015: €4,117 k)
Total revenue increased by 62% to €5,470 k (6M 2015: €3,372 k)
EBITDA loss reduced by 6% to €4,011 k (6M 2015: €4,251 k)
Cash and cash equivalents and time deposits increased by 4% to €48,672 k (12/31/2015: €46,759 k)
Prof. Dolores Schendel, Chief Executive Officer and CSO of Medigene AG, comments: "In recent months we have made huge advances in preparations for the clinical development of TCRs and strengthened our portfolio of patents for this highly innovative therapy. In addition, our DC trial reached a meaningful milestone with progression into Phase II. I am delighted to be able to announce such significant progress in the first five months of my term as CEO of Medigene AG."
Dave Lemus, Chief Operating Officer of Medigene AG adds: "The continued improvement in our financial position in the first six months of 2016 reflects in part the successful repositioning of Medigene as a leading player in the field of immuno-oncology. Moreover, our solid financial situation allows us to increasingly exploit the full potential of our immunotherapy capabilities by funding further research and development activities."
Key figures in first half of 2016:
In € k 6M-2016
6M-2015
Change
Results of operations
Revenue 1,385 1,363 2%
Other operating income 4,085 2,009 103%
thereof gain on sale of intangible assets, net 2,365 0 -
Total revenue 5,470 3,372 62%
Cost of sales -773 -471 64%
Gross profit 4,697 2,901 62%
Selling and general administrative expenses -4,013 -3,476 15%
Research and development expenses -5,079 -4,117 23%
Operating result -4,395 -4,692 -6%
Income from the sale of financial assets 4,242 0 -
Net profit/loss for the period -401 -6,113 -93%
EBITDA -4,011 -4,251 -6%
Earnings per share (€) -0.02 -0.44 -95%
Personnel expenses -4,536 -3,581 27%
Cash flows
Net cash used in operating activities -8,818 -4,953 78%
Net cash from/used in investing activities 10,864 -159 >-200%
Net cash from financing activities -132 195 -168%
Balance sheet data as at June 30, 2016 and December 31, 2015
Cash and cash equivalents and time deposits 48,672 46,759 4%
Total assets 105,599 113,531 -7%
Current liabilities 5,244 9,664 -46%
Non-current liabilities 12,781 13,879 -8%
Shareholders’ equity 87,574 89,988 -3%
Equity ratio (%) 83 79 5%
Employees as at June 30 80 71 13%
FTE as at June 30 73 65 12%
Medigene share as at June 30
Total number of shares outstanding 20,088,260 14,051,815 43%
Total revenue of the Company increased by 62% to €5,470 k in the reporting period (6M 2015: €3,372 k) on account of non-recurring impacts related to the sale of EndoTAG in December 2015. Income of €2,365 k was generated by this sale in the first quarter of 2016. The Company generates its revenue and other operating income from its non-core business.
Research and development expenses increased by 23% in the first six months of 2016 to €5,079 k (6M 2015: €4,117 k) as expected. The increase in these expenses is mainly due to planned increases in expenses for preclinical and clinical trials for Medigene’s immunotherapies which increased significantly by 68% to €4,345 k in the first six months of 2016 (6M 2015: €2,585 k). This increase was partially offset by the decrease in development expenses for other sold products.
Despite higher research and development expenses for Medigene’s immunotherapy programs, the EBITDA loss decreased by 6% in the first half of 2016 to €4,011 k (6M-2015: €4,251 k). Medigene’s EBITDA is derived from the net profit/loss for the period; it excludes any taxes, financial results (comprising interest income, interest expense, other financial result and income the sale of financial assets), foreign exchange gains or losses, share of results of associates, or depreciation or amortization.
Due to non-recurring effects, including the sale of EndoTAG and Immunocore shares, the net loss after taxes improved in the first six months of 2016 to just €401 k (6M 2015: €6,113 k).
The net cash used in operating activities increased to €8,818 k in the first half of 2016 (6M 2015: €4,953 k). This represents an average monthly cash outflow of €1.5 m in the first six months of 2016 (6M 2015: €0.8 m). The major part of the cash used was directed at research and development, sales and administration and an increase in working capital. The current level of cash used in operating activities is not indicative of future trends as it is significantly impacted by non-recurring payments in partner arrangements and research and development expenses, which in turn are impacted by project stage/status.
Medigene recorded a cash inflow from investing activities of €10,864 k in the first six months of 2016 in contrast to a cash outflow of €159 k in the comparable period of the prior year. The cash inflow resulted primarily from the sale of shares in Immunocore Ltd. for €6 m and from the sale of Catherex, Inc. to Amgen Inc. for €4 m.
The cash and cash equivalents and time deposits of the Company amounted to €48,672 k as at the end of the reporting period (December 31, 2015: €46,759 k). Medigene generated a cash inflow of €10,672 k from the above sales.
Financial forecast 2016:
Medigene confirms its financial guidance for the fiscal year 2016. In line with previous expectations, the Company plans to expand its clinical development programs, which will significantly increase R&D expenses in the immunotherapies segment to €9 – 11 m (2015: €5.5 m). The EBITDA loss for 2016 is anticipated to come to €10 -12 m (2015: €9.5 m).
The Company expects total Veregen revenue of €3 – 4 m in 2016 (2015: €3.1 m), and stable or increasing total revenue (2015: €6.8 m). As revenue is not generated in the Company’s core business of immunotherapies, these figures are not indicative of progress in the Company’s core business.. This financial guidance also does not include any possible revenues from potential new partnership agreements, or any exchange rate fluctuation.
The detailed 6-Months Report 2016 is available online at:
View Source