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:
- Phase II of Phase I/II trial with DC vaccine for the treatment of acute myeloid leukaemia (AML) initiated following positive recommendation by DSMB
- Early IIT clinical data for DC vaccines presented at AACR by academic partner Oslo University
- DC patent portfolio strengthened
- Additional viral vector production capacities secured for clinical TCR studies
- Research collaboration started with University of Lausanne for TCRs
- Management change: CSO Prof Dolores Schendel appointed CEO/CSO, Dave Lemus takes over as COO
- Strengthened management team with appointment of three Senior Vice Presidents
Key figures in the first quarter of 2016:
- Increase in total revenue by 132% to €3,909 k (3M 2015: €1,686 k)
- Increase in R&D expenses for immunotherapies by 64% to €1,907 k (3M 2015: €1,166 k)
- EBITDA loss reduced by 54% to €939 k (3M 2015: €2,042 k)
- Cash and cash equivalents and time deposits of €46,310 k as at 31 March 2016 (31 December 2015: €46,759 k)
- 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|
|Other operating income||3,285||972||>200%|
|thereof gain on sale of intangible assets, net (EndoTAG)||2,365||0||-|
|Selling and general administrative expenses||-2,312||-1,740||33%|
|Research and development expenses||-2,395||-1,932||24%|
|Net profit/loss for the period||-1,387||-3,672||-62%|
|Earnings per share (€)||-0.07||-0.26||-73%|
|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%|
|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.
Medigene increased research and development expenses by 24% in the first three months of 2016 to €2,395 k (3M 2015: €1,932 k). The increase in these expenses is mainly due to the intended increase in expenditure for preclinical and clinical trials for Medigene's immunotherapies, which increased significantly by 64% to €1,907 k in the first three months of 2016 (3M 2015: €1,166 k).
In spite of higher development expenses for its immunotherapy programmes, Medigene reduced its EBITDA loss in the first three months of 2016 by 54% to €939 k (3M 2015: EBITDA loss of €2,042 k). Medigene's EBITDA is derived from the net profit/loss for the period; it does not include any taxes, financial result, foreign exchange gains or losses, share of result of associates, or depreciation or amortisation.
Medigene reduced its net loss in the first three months of 2016 by 62% to €1,387 k (3M 2015: €3,672 k).
Medigene reduced its net cash used in operating activities significantly in the first three months of 2016 to €1,064 k (3M 2015: €1,777 k). This represents an average monthly cash outflow of €0.4 m in the first three months of 2016 (3M 2015: €0.6 m). The major part of the cash used was directed at research and development as well as sales and administration.
The cash and cash equivalents and time deposits of the Company amounted to €46,310 k as at the end of the reporting period (31/12/2015: €46,759 k).
Financial forecast 2016:
Medigene confirms its financial guidance for 2016 published in the 2015 annual report. In 2016, Medigene is planning to expand its clinical development programs, which will significantly increase R&D expenses in the field of immunotherapies to €9 - 11 m (2015: €5.5 m). The EBITDA loss is estimated to be €10 -12 m (2015: €9.5 m).
Medigene expects total Veregen® revenue of €3 - 4 m (2015: €3.1 m), and stable or increasing total revenue for 2016 (2015: €6.8 m). Since this revenue is not generated in the Company's core business of immunotherapies, these figures are not indicative of the same. This financial guidance does not include any possible proceeds from potential new partnership agreements, or any exchange rate fluctuation.
The detailed Q1 statement 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 (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.
Julia Hofmann, Dr. Robert Mayer
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