Telephone conference for analysts and the media via webcast today, November 10, 2016, 3 pm CET (Munich/Frankfurt) / 9:00 am EST (New York)
Martinsried, Munich, November 10, 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 nine months of 2016.
Major events since the beginning of 2016
- Strategic partnership with bluebird bio for T cell receptors (TCRs) for cancer immunotherapy
- Phase II part of Phase I/II trial with DC vaccine for the treatment of acute myeloid leukemia (AML) initiated following positive DSMB recommendation
- Collaboration with Max Delbrück Center and The Charité in Berlin for first investigator-initiated clinical TCR trial in Germany.
- TCR technology and DC platform strengthened by new patents
- Management team reinforced
Key figures in the first nine months of 2016:
- Research and development expenses for immunotherapies increased by 80% to € 7,077k as planned (9M 2015: € 3,915k)
- Total revenue increased by 32% to € 7,052k (9M 2015: € 5,326k)
- EBITDA loss increased by 38% to € 9,095k as planned (9M 2015: EBITDA loss of € 6,581k)
- Net loss reduced by 46% to € 5,725k (9M 2015: net loss of € 10,554k)
- Cash and cash equivalents and time deposits of € 43,599k as of September 30, 2016 (December 31, 2015: € 46,759k) not including upfront payment of USD 15m from the partnership with bluebird commencing in the fourth quarter of 2016.
- Financial guidance for 2016 confirmed
- TCRs: Increased investment earmarked for expansion of the TCR platform and generation of TCRs including substantially increasing the size of the team
- DCs: Based on positive safety data and data from the University of Oslo, extension of the length of treatment planned in the current Phase I/II clinical trial, with the duration of the trial remaining unchanged
Prof. Dolores Schendel, CEO and CSO of Medigene AG comments, "The first nine months of 2016 were very successful and topped by the collaboration agreement with bluebird bio. Having our TCR technology validated by such a top tier biotechnology company at this early stage of development is a huge success for Medigene and we are delighted that we can continue to grow on the basis of our scientific and commercial development. In addition to the ongoing generation of new own TCRs and independent of the bluebird bio alliance, we plan to recruit new staff to expand the TCR technology platform. We will implement new tools and technologies to place the TCR technology platform on a broader base and to expand its applicability. We are on schedule with our preparations for the planned clinical TCR trials and our ongoing Phase I/II trial for DC vaccines."
Dave Lemus, Chief Operating Officer of Medigene AG adds, "We are very satisfied with the operational business of our core business to date. Medigene`s collaboration with bluebird bio, a recognized leader in cell-therapies, is a clear validation of our TCR technology and affirms the significant potential of this technology. Moreover, our collaboration with bluebird bio provides us with a further strengthened financial foundation from which we can invest additional resources into our own proprietary products, technologies and people."
| In € k || 9M-2016 |
| 9M-2015 |
| Change |
| Results of operations || || || |
| Total revenue || 7,052 || 5,326 || 32% |
| thereof Veregen® revenue || 2,208 || 2,376 || -7% |
| thereof other operating income || 4,844 || 2,950 || 64% |
| thereof gain on sale of intangible assets, net (EndoTAG) || 2,365 || 0 || - |
| Cost of sales || -1,127 || -862 || 31% |
| Gross profit || 5,925 || 4,464 || 33% |
| Selling and general administrative expenses || -7,645 || -5,517 || 39% |
| Research and development expenses || -7,985 || -6,214 || 29% |
| Operating result || -9,705 || -7,267 || 34% |
| Income from the sale of financial assets || 4,242 || 0 || - |
| Net profit/loss for the period || -5,725 || -10,554 || -46% |
| EBITDA || -9,095 || -6,581 || 38% |
| Earnings per share (€) || -0.29 || -0.67 || -57% |
| Personnel expenses || -6,850 || -5,633 || 22% |
| || || || |
| Cash flows || || || |
| Net cash used in operating activities || -12,992 || -7,642 || 70% |
| Net cash from/used in investing activities || 10,013 || -420 || >-200% |
| Net cash from/used in financing activities || -181 || 43,855 || -100% |
| || || || |
| Balance sheet data as at Sep 30, 2016 and Dec 31, 2015 || || || |
| Cash and cash equivalents and time deposits || 43,599 || 46,759 || -7% |
| Total assets || 115,175 || 113,531 || 1% |
| Current liabilities || 10,972 || 9,664 || 14% |
| Non-current liabilities || 22,149 || 13,879 || 60% |
| Shareholders` equity || 82,054 || 89,988 || -9% |
| Equity ratio (%) || 71 || 79 || -10% |
| || || || |
| Employees as at 30 September || 84 || 71 || 18% |
| FTE as at 30 September || 77 || 65 || 18% |
| || || || |
| Medigene share as at 30 September || || || |
| Total number of shares outstanding || 20,136,887 || 19,678,221 || 2% |
| Share price (XETRA closing price) (€) || 8.19 || 6.14 || 33% |
Financial guidance 2016:
The Company confirms its financial guidance for 2016 published in the 2015 annual report. Due to the expansion of its clinical development programs, Medigene is planning to significantly increase R&D expenses in the field of immunotherapies to between € 9 - 11m (2015: € 5.5m) in 2016. The EBITDA loss for 2016 is expected to lie between € 10 -12m (2015: € 9.5m).
The Company expects total Veregen® revenue of € 3 - 4m (2015: € 3.1m), and stable or increasing total revenue for 2016 (2015: € 6.8m). Since this revenue is not generated in the Company`s core business, these figures are not conclusive with regard to the Company`s core business, i.e. immunotherapies. This financial guidance assumes constant foreign exchange rates.
Outlook for immunotherapies:
TCR-modified T cells (TCRs):
Medigene aims to initiate up to three clinical trials for this therapy, the first to be started in 2017. This publicly sponsored investigator-initiated Phase I trial with participation from Medigene is the first clinical TCR trial in Germany. Medigene-sponsored trials are planned to start in the second half of 2017 and in the second half of 2018. A GMP-compliant manufacturing process for TCRs is being developed in advance of Medigene`s TCR trials. In addition, novel TCRs with specificities for promising tumor-associated antigens will be isolated and further characterized.
In addition to the ongoing generation of new own T cell receptors (TCRs), Medigene plans to recruit new staff to expand the TCR technology platform. The Company intends to implement new tools and technologies to place the TCR technology platform on a broader base and to expand its applicability. A part of Medigene`s TCR team will be dedicated to the partnership recently announced with the US company, bluebird bio. The costs of the personnel working within the framework of this cooperation agreement and the research and development expenses will be fully absorbed by bluebird bio. Medigene will assign the remaining capacity of the expanded TCR team to broaden its own TCR program efforts.
DC vaccines (DCs):
Medigene will continue the current Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML) and, on the back of positive safety data as well as on data from the University Oslo from compassionate uses, will extend the vaccination of the patients until the scheduled completion of the trial (a two-year treatment) with the overall duration of the trial remaining at two years per patient. The former treatment period was one year followed by a one-year observation period. This has now been replaced by a longer treatment period under the adjusted design of the trial. Medigene anticipates additional positive effects for the patients being treated with no change to the safety profile or duration of the overall trial. The final data from the clinical trial will be published in the second half of 2019, as scheduled.