News

Medigene significantly improves financial results for the first three months of 2014

Press and analyst conference call with webcast (in English) today, 15 May 2014, at 3:00 pm (CEST)

  • Total revenue increased by 86%
  • Revenue from Veregen® up by 95%
  • EBITDA loss reduced by 37%
  • Net loss reduced by 38%
  • Acquisition of Trianta Immunotherapies completed

Martinsried/Munich, 15 May 2014. Medigene AG (MDG1, Frankfurt, Prime Standard) published its 3-months report 2014 today. In the reporting period, Medigene significantly increased revenue and reduced loss.

Medigene's total revenue rose by 86% to EUR 2.4 m (Q1 2013: EUR 1.3 m). Revenue from the marketed drug Veregen® increased by 95% to EUR 1.3 m (Q1 2013: EUR 0.7 m).

Compared to the preceding year's reporting period, operating expenses increased slightly by 6% to EUR 3.8 m (Q1 2013: EUR 3.6 m). The increase is due to one-off costs incurred in respect of the acquisition of Trianta Immunotherapies GmbH.

Medigene's EBITDA-based loss was reduced by 37% to EUR -1.5 m (Q1 2013: EUR -2.3 m) due to the increase in revenue and stable operating expenses. The net loss was reduced by 38% to EUR -2.0 m (Q1 2013: EUR - 3.3 m).

As at the reporting date 31 March 2014, cash and cash equivalents totalled EUR 7.2 m. According to current business assumptions, Medigene expects to be financed at least until the second quarter of 2015.

Year-to-date highlights

  • Acquisition of Trianta Immunotherapies completed; new US patents granted for DC vaccine and TCR platform; investigator-initiated clinical trials of DC vaccines ongoing; additional clinical trial of DC vaccine at the planning stage; development of TCR and TAB platforms continues
  • Prof. Dolores J. Schendel appointed as Chief Scientific Officer, effective 1 May 2014
  • Revenue from Veregen® increased by 95% in the first quarter of 2014, market launch in additional countries, new marketing partnerships
  • Licensing agreement signed with Falk Pharma for RhuDex® in hepatology and gastroenterology; further clinical development financed

Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, comments: "We can look back on the first three months of 2014, having achieved pivotal events for the future development of Medigene. Next to the transforming acquisition of Trianta and the partnering of Rhudex® we also achieved significant operational improvements in both our revenue and financial result. The important strategic steps for a continued positive development were taken, now we will focus on driving forward our three immunotherapy platforms with Prof. Schendel on board as CSO of Medigene."

Financial forecast for 2014
Medigene confirms its financial guidance published on the occasion of the annual report 2013 in March 2014. The Company expects a double-digit percentage increase in total revenue in 2014 (2013: EUR 7.6 m). Thereof revenue from Veregen® is likely to amount to EUR 5 m - EUR 6 m (2013: EUR 4.2 m). In addition, Medigene expects to generate revenue consisting mainly of reimbursements of development costs for EndoTAG®-1 from SynCore, of non-cash payments from a transaction with Medigene's former drug Eligard® as well as pro rata upfront or milestone payments from partnerships. The EBITDA loss in 2014 is likely to be reduced to EUR 4 m - EUR 6 m (2013: EUR 8.3 m). According to the current business assumptions, Medigene expects to be financed at least until the second quarter of 2015.

Consolidated income statement (abbreviated)

In € k Q1-2014 Q1-2013 Change
Revenue Veregen® 1,329 680 95%
thereof Veregen® royalties 423 558 -24%
thereof Veregen® revenue from supply chain 226 70 >200%
thereof Veregen® milestone payments 680 52 >200%
Other operating income 1,101 629 75%
Total revenue 2,430 1,309 86%
Cost of sales -267 -223 20%
Gross profit 2,163 1,086 99%
Selling, general and administrative expenses -2,210 -1,821 21%
Research and development expenses -1,596 -1,753 -9%
Operating result -1,643 -2,488 -34%
Net result for the period -2,044 -3,273 -38%
EBITDA  -1,452 -2,296 -37%

Financial results in detail:

Revenue and other operating income
In the first three months of 2014, Medigene's total revenue rose by 86% to EUR 2,430 k (Q1 2013: EUR 1,309 k). Medigene achieved sales growth of 95% to EUR 1,329 k (Q1 2013: EUR 680 k) with the drug Veregen®. Revenue from Veregen® sales comprised royalties, revenue from product deliveries (supply chain) and milestone payments. Compared with the very strong previous year's quarter, royalties received in the first quarter of 2014 were down to EUR 423 k (Q1 2013: EUR 558 k). This was due to an overall weak US dermatology market while a strong increase in revenues was recorded in the remaining markets. At the same time, revenue from Veregen® supply chain to sales partners rose significantly to EUR 226 k in the first quarter of 2014 (Q1 2013: EUR 70 k) and milestone payments received from partner companies were up to EUR 680 k (Q1 2013: EUR 52 k), mainly attributable to a milestone payment received as part of the agreement signed with the new marketing partner Taurus Pharma GmbH.

In addition, Medigene's other operating income rose by 75% to EUR 1,101 k (Q1 2013: EUR 629 k). On the one hand, this included regular, non-cash income of EUR 623 k (Q1 2013: EUR 623 k) from the transfer of rights to Medigene's former drug Eligard®, agreed with US financial investor Cowen Healthcare Royalty Partners in 2012. On the other hand, the figure encompasses development cost reimbursements which Medigene receives under the global EndoTAG®-1 partnership agreement with SynCore Biotechnology that amounted to EUR 441 k in the reporting period (Q1 2013: EUR 0).

Selling, general and administrative expenses
Compared with the previous year's reporting period, selling, general and administrative expenses were up from EUR 1,821 k (Q1 2013) to EUR 2,210 k in the first quarter of 2014. This amount comprises selling expenses of EUR 563 k (Q1 2013: EUR 616 k) as well as general and administrative expenses of EUR 1,647 k (Q1 2013: EUR 1,205 k). General and administrative expenses increased due to one-off costs incurred in respect of the acquisition of Trianta Immunotherapies GmbH.

Research and development expenses
Research and development expenses decreased to EUR 1,596 k in the first quarter of 2014 (Q1 2013: EUR 1,753 k). The reduction in these expenses was mainly attributable to planned lower expenses for preclinical and clinical trials. In contrast, personnel expenses were up following the transfer of Trianta employees who joined Medigene.

EBITDA
Medigene's EBITDA is derived from the result for the period excluding taxes, the financial result, foreign exchange gains and losses, share of result of associates and depreciation and amortisation. The result on an EBITDA basis was up by 37% to EUR -1,452 k in the first quarter of 2014 (Q1 2013: EUR -2,296 k).

The detailed 3-Months Report 2014 is available at www.medigene.com/reports

Press and analysts' conference call: A press and analysts conference call (in English) will be held today at 3:00 p.m. CEST 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. Medigene concentrates on the development of personalized T cell immunotherapies with focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partners. Medigene has various drug candidates in clinical development and it is developing highly innovative treatment platforms. 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® EndoTAG® and Veregen® are registered trademarks of Medigene AG. Polyphenon E® is a trademark of Mitsui Norin Co., Ltd. These trademarks may be owned or licensed in select locations only.

Contact
Julia Hofmann, Claudia Burmester
Tel.: +49 - 89 - 20 00 33 - 33 01
Email: investor@medigene.com

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