• Preliminary results confirmed:
o Total revenue increased by 82%
o EBITDA loss reduced by 75%
o Net result improved by 44%
• Substantial investments planned in immunotherapies
Martinsried/Munich, 25 March 2015. Medigene AG (MDG1, Frankfurt, Prime Standard) today published its final financial results for the fiscal year 2014, confirming the preliminary results announced earlier this month. The company significantly improved its revenue, EBITDA and net result during the period ending 31 December 2014.
Medigene’s total revenue rose by 82% to EUR 13.8 m (2013: EUR 7.6 m). Revenue from the marketed drug Veregen® increased by 23% to EUR 5.2 m (2013: EUR 4.2 m). The company reduced its EBITDA loss by 75% to EUR 2.1 m (2013: EUR 8.3 m). The net loss was reduced by 44% to EUR 5.8 m (2013: EUR 10.3 m).
With these final results, Medigene surpassed its financial forecast announced at the beginning of 2014 of an increase in total revenue by 20-30% compared to 2013, Veregen® revenues of EUR 5-6 m and an EBITDA-loss of EUR 4-6 m.
Operational Highlights in 2014:
- Acquisition of Trianta Immunotherapies (now Medigene Immunotherapies)
- Focus on immunotherapies with significant progress in all clinical and preclinical immunotherapy programmes; 2015 first company-sponsored clinical trial with DC vaccine started
- Successful capital increase to fund further development of newly acquired immunotherapy pipeline
- Outlicensing of RhuDex® to Falk Pharma for hepatology and gastroenterology
Dr. Frank Mathias, Chief Executive Officer of Medigene AG, commented: “2014 was a great and transformative year for our organization. We successfully repositioned Medigene as an immunotherapy company. The acquisition of Trianta and the integration of a highly qualified team at Medigene Immunotherapies have added lots of expertise, innovation and inspiration. We will continue to fully focus on the development of our immunotherapies and are excited about their potential to impact the way cancer is treated for many patients. We are now looking forward to accelerating the progress of our immunotherapy pipeline in the coming months. The successfully conducted outlicensing of EndoTAG®-1 and Rhudex® strongly supports this focus.”
Prof. Dolores Schendel, Chief Scientific Officer of Medigene AG: “We are very proud of the progress Medigene has made since the acquisition of Trianta one year ago. The pharmaceutical development expertise and financial resources provided by Medigene enable us to strongly advance our three complementary immunotherapy platforms, including the recent start of our own clinical trial with our new generation DC vaccine in AML. Furthermore, we are making progress in GMP manufacturing and preparations for the start of a clinical trial with the TCR therapy platform. We are focussed on bringing our highly innovative approaches to patients as soon as possible.”
Peter Llewellyn-Davies, Chief Financial Officer of Medigene AG: “In 2014, we significantly improved all our key financial parameters and strengthened our cash position through a successful capital measure, adding new renowned international investors to our shareholder base. We enter 2015 prepared to continue to make significant investments in our pipeline to enable the prompt development of our promising immunotherapy programmes. Our financial guidance for 2015 provides evidence of our commitment to patients and to investors to deliver on our business strategy, to spend prudently, and to invest in the innovation and development of therapies that re-engage the immune system to fight cancer.”
| consolidated income statement (abbreviated) | |||
| In € k | 2014 | 2013 | change |
| Revenue Veregen® | 5,195 | 4,209 | 23% |
| thereof royalties | 2,352 | 2,585 | -9% |
| thereof revenue from supply chain | 2,118 | 1,326 | 60% |
| thereof milestone payments | 725 | 298 | 143% |
| Other operating income | 8,589 | 3,383 | 154% |
| Total revenue | 13,784 | 7,592 | 82% |
| Cost of sales | -2,086 | -1,735 | 20% |
| Gross profit | 11,698 | 5,857 | 100% |
| Selling, general and administrative expenses | -7,081 | -8,273 | -14% |
| Research and development expenses | -7,498 | -6,605 | 14% |
| Operating result | -2.881 | -9,021 | -68% |
| Net result for the year | -5,757 | -10,282 | -44% |
| EBITDA | -2,071 | -8,270 | -75 % |
Financial forecast for 2015:
In 2015, the Company expects a double-digit percentage increase in Veregen® royalties (2014: €2.4 m) based on the assumptions made by Medigene’s partners. In spite of reduced milestone payments, total revenue for Veregen® is planned to remain stable (2014: €5.2 m) in 2015. Other operating income will mainly consist of reimbursements of development costs for EndoTAG®-1 by SynCore and of stable non-cash income from Cowen. Medigene plans to significantly increase its R&D expenses for its proprietary immunotherapy programmes in 2015. These expenses are planned to strongly increase to €7 - 9 m (2014: €2.9 m). Due to this increased investment in Medigene’s innovation the anticipated EBITDA loss will increase to €11 - 13 m in 2015 (2014: €2.1 m). Management expects that the company will be financed into the second quarter of 2016, without considering any potential additional licensing agreements or capital measures.
Outlook for Immunotherapies:
DC vaccines
The current investigator-initiated trials (IITs) being conducted at the University Hospital in Oslo (phase II trial in prostate cancer) and at the University Hospital in Munich (phase I/II trial in acute myeloid leukaemia, AML) will be continued. Additionally, a compassionate use programme, including patients with different types of tumour is currently ongoing at the Oslo University Hospital in order to test Medigene’s DC vaccine. Medigene’s own clinical trial recently started in AML should generate further clinical feasibility and safety data for Medigene’s personalised DC vaccines.
TCR-modified T cells
The development of a GMP-compliant manufacturing process for adoptive T cell therapy using TCR-modified T cells will be continued. Medigene prepares the clinical development of the first product candidates. In addition, novel TCRs with specificities for promising tumour-associated antigens will be isolated and further characterised.
TABs
Preclinical development of the T cell specific monoclonal antibodies (TABs) continues with the aim of achieving proof of principle.
The detailed interactive annual report 2014 is available online at http://annualreport2014.medigene.com
Press and analysts’ conference call: A press and analysts conference call (in English) will be held today at 3:00 p.m. CET / 10:00 a.m. 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. Medigene concentrates on the development of personalized T cell immunotherapies with a focus on haematological malignancies. Medigene is the first German biotech company to have revenues from a marketed product, which is distributed by commercial partner companies. Medigene has advanced drug candidates which are licensed to partners and additional candidates in clinical development. The company is developing highly innovative treatment platforms concentrating on cancer and autoimmune diseases. 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®, Veregen®, EndoTAG® and RhuDex® are registered trademarks of Medigene AG. Medigene ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. Trianta ImmunotherapiesTM is a registered trademark of Medigene Immunotherapies GmbH. These trademarks may be owned or licensed in select locations only.
Contact Medigene
Julia Hofmann, Anja Clausnitzer
Tel.: +49 - 89 - 20 00 33 - 33 01
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