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2016-05-12

Medigene AG: Medigene reports results of first quarter 2016

Medigene AG / Medigene reports results of first quarter 2016. Processed and
transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely
responsible for the content of this announcement.
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:

* 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

Company:

* 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 |
| 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.

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:
www.annualreport2015.medigene.comhttp://www.medigene.com/media-investors/reports-presentations/financial-...

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 visitwww.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.

Contact Medigene

Julia Hofmann, Dr. Robert Mayer
Tel.: +49 - 89 - 20 00 33 - 33 01
Email:investor@medigene.com

In case you no longer wish to receive any information about Medigene, please
inform us by e-mail (investor@medigene.com). We will then delete your address
from our distribution list.

Press release English PDF
http://hugin.info/132073/R/2011888/745011.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medigene AG via Globenewswire

HUG#2011888

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