Conference call and webcast (in English) today, 5 August 2016, at 3:00 pm CEST
(9:00 am EDT)
Martinsried/Munich, 5 August 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 six months of 2016.
Major events since the beginning of 2016:
- 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
- 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|
|Other operating income||4,085||2,009||103%|
|thereof gain on sale of intangible assets, net||2,365||0||-|
|Cost of sales||-773||-471||64%|
|Selling and general administrative expenses||-4,013||-3,476||15%|
|Research and development expenses||-5,079||-4,117||23%|
|Income from the sale of financial assets||4,242||0||-|
|Net profit/loss for the period||-401||-6,113||-93%|
|Earnings per share (€)||-0.02||-0.44||-95%|
|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%|
|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:
Press and analysts' conference call: A press and analysts conference call (in English) will be held today at 3:00 pm CEST / 9:00 am EDT 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.
Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
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