Press and analysts conference call with webcast today, 8 November 2013, 10:00 am (CET)
- Further increase in revenue with stable operating costs
- Veregen® in-market sales growth of 40%
- Progress achieved in development projects
Martinsried/Munich, 8 November 2013. In the first nine months of 2013, Medigene AG (MDG1, Frankfurt, Prime Standard) reported an increase in revenue with stable operating costs.
Based on significant growth of in-market sales (+ 40%), revenue from royalties for Veregen® increased by 39% to EUR 1.9 million (9M 2012: EUR 1.4 million). Veregen® revenue increased by 14% to EUR 2.8 million in the first nine months of 2013 (9M 2012: EUR 2.5 million). Total revenue amounted to EUR 5.1 million compared to EUR 4.8 million in the same period of the previous year, when Medigene received a one-off compensation payment amounting to EUR 0.4 million. Excluding this one-time effect in the previous year, total revenue in the first nine months of 2013 increased by 17%.
With stable operating expenses of EUR 10.7 million (9M 2012: EUR 10.9 million), Medigene's EBITDA result of EUR -6.1 million (9M 2012: EUR -1.3 million) was in line with the company's expectations. Excluding the preceding year's one-time effects (a EUR 5 million milestone payment from discontinued operations and a compensation payment of EUR 0.4 million), Medigene's EBITDA result improved by 8% compared to last year's reporting period.
The net result for the first nine months of 2013 amounted to EUR -7.7 million (9M 2012: EUR -0.2 million). The previous year's result was positively influenced by the aforementioned one-time effects and by the revaluation of an investment and without these, EUR -7.8 million was posted (9M 2012).
Cash and cash equivalents as at 30 September 2013 totalled EUR 11.7 million. Medigene expects cash reach at least until early 2015.
Highlights in the first nine months of 2013
- Revenue from royalties for Veregen® increased by 39%; further market launches, approvals and marketing partnerships
- Global partnership agreement for EndoTAG®-1 concluded; phase III clinical trial funded
- Preparation of phase III trial for EndoTAG®-1 and phase II trial for RhuDex®
- Share consolidation successfully concluded with 4:1 capital reduction
Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG, comments: "In the first nine months of 2013, we realised positive sales and expenses developments, as well as making important progress with our drug development projects. It remains our objective to continue developing and strengthening the product pipeline. Through the successfully completed capital reduction, we have increased Medigene's transaction ability and therefore provided an important foundation for exploring strategic options."
Consolidated income statement (abbreviated)
|In EUR k||9M 2013||9M 2012||Change|
|thereof revenue from supply chain||735||517||42%|
|thereof milestone payments||213||608||-65%|
|Other operating income||2,284||2,276||0%|
|Total revenue before one-time effect||5,121||4,369||17%|
|Cost of sales||-1,055||-775||36%|
|Selling, general and administrative expenses||-5,616||-5,728||-2%|
|Research and development expenses||-5,119||-5,169||-1%|
|Income from revaluation of an investment||0||2,213||-|
|Net result for the period||-7,728||-167||>200%|
|Net result for the period before one-time effects||-7,728||-7,770||-1%|
|EBITDA before one-time effects||-6,106||-6,659||-8%|
Financial guidance 2013
Medigene anticipates the financial results 2013 to be within the announced guidance. The projected total revenue includes Veregen® revenue, income from the partnership for EndoTAG®-1 with SynCore, and non-cash income from the Eligard® deal concluded in 2012. Total revenue 2013 is expected to be at the lower end of the guided range of EUR 8 - 9 million due to a slight shift in market launches of Veregen® in a number of countries. The respective Veregen® revenues will be recaptured in 2014. The loss on an EBITDA basis is expected to be in the middle of the guided range of EUR 8 - 10 million. Medigene's management anticipates that the funding of the company is secured until at least the beginning of 2015.
Medigene expects further market approvals and market launches of Veregen® in several additional countries in the future. Marketing authorisation applications for nine remaining European countries participating in the mutual recognition procedure are scheduled for 2014. For the global commercialisation of Veregen®, Medigene plans to enter into additional partnership agreements. The company anticipates continued significant double-digit growth of Veregen® in-market sales.
Together with its partner SynCore, Medigene plans a pivotal global phase III trial of EndoTAG®-1 in triple-negative breast cancer (TNBC), with the aim to achieve market approvals worldwide. As part of the global development and marketing partnership, SynCore has undertaken to finance the phase III trial in full. This trial is expected to start in the second half of 2014.
Medigene plans to conduct a phase II clinical trial in primary biliary cirrhosis (PBC) to confirm the mode of action of RhuDex® in autoimmune diseases. Subject to the successful completion of the preparatory work and trial approval by the regulatory authorities, the start of the PBC phase II trial is scheduled for the first half of 2014. Medigene is looking for a partner to co-finance the study.
The preclinical long-term protection study in cooperation with the Pennsylvania State University aims to demonstrate long-term protection against infection with various HPV types will be continued. The AAVLP technology is available for partnerships and licensing.
The detailed nine-month report 2013 is available online at www.medigene.com/media-investors/reports-presentations/financial-reports
Press and analysts' conference call: A press and analysts conference call (in English) will be held today at 10:00 a.m. CET and will be webcast live. The synchronized presentation slides and a recording can be accessed 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 focuses on clinical research and development of novel drugs against cancer and autoimmune diseases. Medigene is the first German biotech company to have revenues from a marketed product, Veregen®, which is distributed by partner companies. It has two drug candidates in clinical trials, EndoTAG®-1 and RhuDex®; and is developing an innovative vaccine technology. Further information at 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®, Veregen®, EndoTAG® and RhuDex® are registered trademarks of Medigene AG. These trademarks may be owned or licensed in select locations only.
Julia Hofmann, Claudia Burmester
Tel.: +49 - 89 - 20 00 33 - 33 01
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