Medigene AG: Medigene publishes its 2016 annual report and outlook for 2017

Conference call and webcast, March 23, 2017 at 3pm CET (Frankfurt) / 10am EST (New York)

Martinsried/Munich (pta006/23.03.2017/07:30 UTC+1) -
- Total revenue increases 43% to Eur9.8 m
- Cash and cash equivalents rise to Eur52.6 m
- Financial guidance for 2016 met
- Strategic partnership with bluebird bio for T cell receptors
- Phase II of the Phase I/II clinical trial of DC vaccines gets underway
- Outlook: Start of first clinical trials of TCR scheduled for 2017

Medigene AG (MDG1, Frankfurt, Prime Standard, TecDAX), a biotech firm specializing in immunocology with clinical projects focusing on the development of T cell cancer therapies today released its financial results and annual report for 2016 and outlook for 2017.

Prof. Dolores Schendel, CEO/CSO at Medigene AG, commented: "The great progress we made in 2016 has significantly strengthened Medigene's position and reputation in the dynamic market of immunotherapies for the treatment of cancer. Supported by a strong senior leadership team expanded in 2016, we continue on our path of developing Medigene into a global leader in the field of T-cell based immunotherapies. In 2017 we will focus on the clinical progress in the ongoing Phase II DC trial, while initiating our clinical program with TCRs and driving forward our strategic cooperation with bluebird bio.

Dr. Thomas Taapken, CFO of Medigene AG, adds: "Our solid financial situation allows us to continue developing the potential of our immunotherapy platform as planned. In 2017 we will make targeted investments in advancing research and development activities to continue developing the value of Medigene."

Financial highlights in 2016:

In Eur K	2016	2015	Change
Total revenue	9,749	6,808	43%
Revenue bluebird	1,053	0	-
Revenue VeregenÒ	3,048	3,101	-2%
Gain on sale of intangible assets, net (EndoTAG®) (one-time effect)	2,365	0	-
Further other operating income	3,283	3,707	-11%
Research and development expenses	-11,538	-8,529	35%
thereof immunotherapies	-10,468	-5,534	89%
Selling expenses	-4,167	-2,141	95%
General and administrative expenses	-5,858	-5,474	7%
Net profit/loss for the year	-9,492	-12,999	-27%
Income from the sale of financial assets	4,242	0	-
(shares in Immunocore)
EBITDA	-12,371	-9,495	30%
Earnings per share (basic and diluted) (Eur)	-0.48	-0.77	-38%
Cash, cash equivalents and time deposits	52,63	46,759	13%
Total assets	111,715	113,531	-2%
Shareholders' equity	78,592	89,988	-13%
Equity ratio (%)	70%	79%	-11%
Employees as at December 31	88	73	21%

- The increase of 43% in the total revenue of the Company to Eur9,749 k (2015: Eur6,808 k) is mainly attributed to the non-recurring income of Eur2,365 k from the sale of EndoTAG.

- During the fiscal year, revenue of Eur894 k (2015: Eur0 k) from the strategic research and development cooperation with bluebird bio, Inc. was realized (pro rata share of the upfront payment of Eur13.4 m to be spread over an estimated period of 45 months corresponding to the expected duration of the underlying services). In addition, Medigene was reimbursed for research and development expenses of Eur159 k (2015: Eur0 k) incurred within the framework of this cooperation.

- Selling expenses increased to Eur4,167 k (2015: Eur2,141 k) in the reporting period, mainly on account of an accrual of Eur1,662 k associated with the minimum purchase obligation for Veregen® arising in earlier periods.

- Research and development expenses increased over the reporting period to Eur11,538 k (2015: Eur8,529 k) due to the increased activities in the immunotherapy R&D projects. This includes an increase of 89% in research and development expenses for Medigene's immunotherapy programs to Eur10,468 k (2015: Eur5,534 k).

- Net loss for the year was reduced by 27% to Eur9,492 k (2015: Eur12,999 k). The net result for 2016 was positively influenced by income of Eur4,242 k from the sale of shares held in Immunocore, which was recorded below the operating result.

- Cash and cash equivalents and time deposits amounted to Eur52,630 k on the reporting date (12/31/2015: Eur46,759 k).

Operative highlights 2016:

- Strategic partnership with bluebird bio for T-cell receptors (TCRs) in cancer immunotherapy
In September 2016, Medigene and US based bluebird bio, Inc. entered into a license agreement for the joint development of TCR immunotherapies targeting four molecular targets of bluebird. Medigene is responsible for generating and preparing the TCRs identified in the collaboration. Medigene received a non-recurring upfront payment of US$15 m (Eur13.4 m) and has a right to potential milestone payments, which in aggregate could amount to over US$1 bn. Additionally, Medigene will receive R&D funding for work performed in the collaboration and is eligible for tiered royalties on net sales up to a double-digit percentage.

- Phase II of the Phase I/II clinical trial of DC vaccines gets underway
In April 2016, the Company announced the beginning of the Phase II part of Medigene's clinical Phase I/II trial of DC vaccines for acute myeloid leukemia (AML). The independent Data and Safety Monitoring Board (DSMB) had previously come to a positive evaluation of the safety and tolerability data obtained in Phase I part of this trial after the first six patients were treated at least four times with Medigene's DC vaccine. The treatment of the first patient in the Phase II part of the trial commenced in April 2016.

- New approach presented for the development of TCRs to target neoantigens
At the Neoantigen Summit in Boston, USA, which was held in November 2016, Prof. Dolores Schendel presented a new approach to developing T-cell receptors (TCR) targeting neoantigens. Medigene demonstrated that T-cells from healthy donors could be utilized to identify and characterize TCR candidates against neoantigens for individualized cancer patient treatment. Characteristic, patient-specific neoantigens open up new avenues for genuinely personalized immunotherapies to fight cancer.

- Collaboration for publicly funded investigator-initiated clinical TCR trial (IIT) announced
In June 2016, Medigene announced a collaboration with Max Delbrück Center, Berlin, and The Charité - University Clinic, Berlin, to conduct a first investigator-initiated TCR trial. This Phase I trial for the treatment of multiple myeloma is being sponsored by the Federal Ministry of Education and Research (BMBF) and is considered to be the first clinical trial of TCRs in Germany.

Outlook for immunotherapies in 2017:

- TCR-modified T cells (TCRs)
Medigene aims to initiate two own clinical trials for this therapy, the first to be started in the second half of 2017 and the second in the second half of 2018. In addition, Medigene is participating in a Phase I investigator-initiated clinical trial that is also scheduled to begin in 2017 and anticipated to be the first TCR clinical trial in Germany. The development of a GMP-manufacturing process for TCRs is being completed ahead of the start 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 generating a pipeline of own new TCRs, Medigene is planning to broaden the TCR technology platform by expansion of the R&D team. The Company intends to implement new automated processes and technologies around the TCR technology platform to extend its possible applications. A part of Medigene's TCR team will be dedicated to the partnership announced at the end of 2016 with bluebird bio. Medigene expects to rapidly progress with this collaboration in 2017. Bluebird will cover the incurred R&D cost within the scope of the collaboration. Additional capacity within the expanded TCR team will be deployed to broaden Medigene's own TCR program efforts.

- DC vaccines (DCs)
Medigene will continue with the current Phase I/II clinical trial for the treatment of acute myeloid leukemia (AML) as planned and expects to successfully complete patient recruitment in the course of 2017. The final data from the clinical trial will be available in the second half of 2019, as scheduled.

- T-cell-specific monoclonal antibodies (TABs)
Preclinical development will be continued with the objective of obtaining proof of principle.

Financial guidance 2017:

The financial guidance for 2017 reflects Medigene's alignment and continued focus on its core business of immunotherapies.

- Revenue: Planned total revenue in 2017 between Eur8 - Eur10 m. This projection does not include future milestone payments from the current strategic partnership with bluebird or revenue from any potential new transactions.

- R&D expenses: Due to the progress of Medigene's clinical programs in the field of immunotherapies and due to further expansion of the R&D team, the company expects rising research and development expenses to Eur16 - 18 m.

- Projected EBITDA loss of Eur16 - Eur18 m.

- For 2017 Medigene anticipates cash utilization of between Eur23 - 27 m, partly due to non-recurring effects such as investments in laboratory infrastructure. Likewise, this estimate does not include potential cash inflows arising from milestone payments under the existing strategic partnership with bluebird or cash inflows from any potential new collaborations.

- Based on its current planning, the Company has sufficient financial resources to fund business operations well beyond the forecast horizon of two years.

The full version of the annual report for 2016 can be downloaded here:
http://www.medigene.com/investors-media/reports-presentations/

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 10:00 am EST (New York) and transmitted live in the internet. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at http://www.medigene.com/investors-media/reports-presentations/webcasts/.

Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard, TecDAX) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies, with associated projects currently in pre-clinical and clinical development.

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.

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