Analysts' telephone conference with webcast (English) today, 3:30 p.m. (CEST)
Total revenue from continued operations increased to EUR 1.6 million (Q1 2011: EUR 0.6 million)
from continued operations improved to EUR -2.0 million (Q1 2011: EUR -2.9 million)
total: EUR -2.0 million (Q1 2011: EUR 19.2 million due to one-time effect)
from continued operations improved to EUR -2.3 million (Q1 2011: EUR -3.1 million)
total: EUR -2.3 million (Q1 2011: EUR 17.0 million due to one-time effect)
Important developments in product portfolio
Confirmation of 2012 guidance
Martinsried/München, May 11, 2012. Medigene AG (Frankfurt, Prime Standard; MDG) reports the financial results of the first quarter of 2012. The company improved revenues as well as EBITDA and net result from continued operations. Medigene increased total revenue to EUR 1.6 million (Q1 2011: EUR 0.6 million) and reduced EBITDA-loss from continued operations to EUR -2.0 million (Q1 2011: EUR -2.9 million) as well as net loss from continued operations to EUR -2.3 million (Q1 2011: EUR -3.1 million).
Last year's reporting period included a non-recurring item, specifically EUR 20 million received for the sale of the Eligard® rights to Medigene's marketing partner Astellas, which was recorded as "discontinued operations" according to IFRS. Combining continued and discontinued operations, Medigene achieved revenue of EUR 1.6 million (Q1 2011: EUR 27.9 million), EBITDA of EUR -2.0 million (Q1 2011: EUR 19.2 million) and a net result for the period amounting to EUR -2.3 million (Q1 2011: EUR 17.0 million).
Important developments in product portfolio since the beginning of 2012:
- Increase in revenues by 59%
- Positive decision on market approval of Veregen® in 17 additional European countries
- Market approval in Switzerland, Sweden, Norway and Poland
- Agreement with EIP Eczacibasi for the commercialization of Veregen® in Turkey
Final milestone payment of EUR 5 million for the sale of Eligard® rights received
Clinical formulation study of RhuDex® for oral treatment of autoimmune diseases initiated and successfully completed
US patent granted for the application of EndoTAG®-1 in combination with taxanes for the treatment of triple-negative breast cancer
AAVLP Vaccine Technology:
Presentation of positive preclinical data at the World Vaccine Congress, US
Dr. Frank Mathias, CEO of Medigene AG, comments: "The results achieved in the first three months of 2012 confirm the positive development of our focused activities. We are making progress in all our portfolio projects: With increasing sales, additional market approvals, and new partnership agreements, the commercialization of Veregen® is gathering momentum. RhuDex® has successfully taken an important step in its clinical development, and the continuation of its clinical development is in preparation. With regard to EndoTAG®-1 and AAVLP, we have also reported positive news. We feel confirmed in the pursuit of our strategy, and well-positioned to further strengthening our pipeline."
Arnd Christ, CFO of Medigene AG, adds: "We are very happy with the development of our continued operations which will contribute to our company's long-term financial stability. Despite increasing expenditures for clinical development, our overall costs remained stable. Medigene's sound financial and structural situation allows us to take further strategic steps towards future growth."
Financial results of the first quarter of 2012 in detail:
Product sales and other income
During the first three months of 2012, total revenue from continued operations increased to EUR 1,622 thousand (Q1 2011: EUR 648 thousand). It was generated on the one hand from product sales of the drug Veregen® in the USA, Germany, Austria, and Spain which rose by 59% to EUR 604 thousand (Q1 2011: EUR 380 thousand). Veregen® revenues comprise the sale of the product to the marketing partner totaling EUR 225 thousand (Q1 2011: EUR 0), royalties on market sales of Veregen® by the partners totaling EUR 377 thousand (Q1 2011: EUR 277 thousand), and milestone payments which amounted to EUR 2 thousand (Q1 2011: EUR 103 thousand).
On the other hand total revenue includes other income totaling EUR 1,018 thousand (Q1 2011: EUR 268 thousand), which consists mainly of Eligard® product sales. Since March 2011, this corresponds to 2% of the net sales generated by Astellas and is posted as other operating income (Q1 2012: EUR 613 thousand). In addition, Medigene received a payment of compensation for incurred expenses of EUR 390 thousand.
Revenue from discontinued operations decreased to EUR 16 thousand (Q1 2011: EUR 27,296 thousand). Last year's reporting period included a non-recurring item, specifically EUR 20 million received for the sale of the Eligard® rights to Astellas. In addition, product revenue and royalties of Eligard® achieved through the end of February 2011 are posted as revenue from discontinued operations.
Cost of sales
Cost of sales from continued operations totaled EUR 278 thousand in the first quarter of 2012 (Q1 2011: EUR 80 thousand), and were incurred for the purchase of Veregen® and royalty payments for the sale of Veregen®.
Gross profit from continued operations increased to EUR 1,344 thousand in the first quarter of 2012 (Q1 2011: EUR 568 thousand).
Selling, general and administrative expenses
Compared to last year's reporting period, selling, general, and administrative expenses from continued operations increased from EUR 1,644 thousand (Q1 2011) to EUR 1,761 thousand (Q1 2012). This amount is made up of EUR 541 thousand selling expenses (Q1 2011: EUR 451 thousand), and EUR 1,220 thousand general and administrative expenses (Q1 2011: EUR 1,193 thousand). The increase was incurred by the commercialization of Veregen® and business development activities.
Research and development expenses
Research and development expenses were reduced to EUR 1,840 thousand in the first quarter of 2012 (Q1 2011: 2,029 TEUR). This decrease was due mainly to the reduced personnel and lease rental charges, whereas the clinical research expenses increased.
The result from continued operations on an EBITDA basis totaled EUR -2,047 thousand in the first quarter of 2012 (Q1 2011: EUR -2,889 thousand). The result from continued and discontinued operations on an EBITDA basis totaled EUR -2,050 thousand (Q1 2011: EUR 19,211 thousand). The result on an EBITDA basis in last year's reporting period was influenced by a non-recurring item comprised of EUR 20 million income for the sale of the Eligard® rights.
Result from investment in associate companies
The result from investments in associate companies totaled EUR -19 thousand in the first quarter of 2012 (Q1 2011: EUR -521 thousand). It was allocated to the associate Catherex, Inc. Following the issue of new shares of Immunocore Ltd., Medigene's ownership share in the company decreased to 19.06% as of March 31, 2012. Since Medigene holds less than 20% of the voting rights, this investment is no longer rated according to the equity method. Starting in the first quarter of 2012, the investment in Immunocore Ltd. is reported as a financial asset in the balance sheet.
3-months result 2012
In the first three months of 2012, a net result for the period of EUR -2,278 thousand (Q1 2011: EUR 16,985 thousand) was generated. Compared to last year's reporting period, the loss for the period from continued operations amounted to EUR -2,275 thousand (Q1 2011: EUR -3,105 thousand), and the result for the period from discontinued operations was EUR -3 thousand (Q1 2011: EUR 20,090 thousand). The profit in last year's reporting period was generated mainly by the milestone payments received for the sale of the Eligard® rights.
Cash from/used by operating activities
Cash used by operating activities totaled EUR -2,531 thousand in the first quarter of 2012 (Q1 2011: cash from operating activities EUR 14,463 thousand). In last year's reporting period, the cash inflow mainly resulted from a EUR 15 million milestone payment by Astellas.
Average monthly cash flow from operating activities
Average monthly net cash used by operating activities in the first quarter of 2012 totaled EUR -0.8 million (Q1 2011: cash inflow EUR 4.8 million). Cash used by operating activities is of limited informative value as regards future development, since it is significantly influenced by non-recurring payments received within partnership agreements, as well as research and development expenses, the amount of which depends on the project status.
As of closing date March 31, 2012, cash and cash equivalents totaled EUR 10,122 thousand. In addition, Medigene received a milestone payment of EUR 5 million from Astellas for the sale of the Eligard® rights.
Consolidated income statement (abbreviated)
|In EUR thousand||Q1 2012||Q1 2011||Change|
|thereof Veregen® product revenue and royalties||602||277||117%|
|Cost of sales||-278||-80||>200%|
|Selling, general, and administrative expenses||-1,761||-1,644||7%|
|Research and development expenses||-1,840||-2,029||-9%|
|Result from continued operations before tax||-2,275||-3,466||-34%|
|Result from continued operations||-2,275||-3,105||-27%|
|Product sales from discontinued operations||16||27,296||-|
|Result from discontinued operations||-3||20,090||-|
|Net result for the period||-2,278||16,985||-|
Financial forecast for 2012
Medigene confirms the financial guidance for fiscal year 2012. The company expects increasing revenue from continued operations to be greater than EUR 5 million. In addition, Medigene has earned revenue from discontinued operations of EUR 5 million, relating to the sale of the Eligard® rights. Higher expenses in the further clinical development of RhuDex® are expected to lead to a loss on an EBITDA basis in the mid-single digit million euro range. Based on current business planning and scenarios developed on the basis of this planning, the management expects the company funding to be secured beyond the end of 2013.
Medigene continues to benefit from a 2% royalty rate on Eligard® net sales achieved by Astellas.
Market launch of Veregen® in Spain is scheduled for the second quarter of 2012. On the basis of the requlatory decision to grant marketing authorization of Veregen® in 17 additional European countries (Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Finland, France, Greece, Hungary, Luxembourg, the Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, and Sweden), the respective national marketing authorizations will be issued separately by the authorities in each country. Furthermore, Medigene anticipates positive decisions in 2012 regarding marketing authorization in selected countries outside the EU, as well as market launch in additional selected countries. For the global commercialization of Veregen®, Medigene is planning to continue its licensing strategy. Medigene assumes a further increase in Veregen® sales revenue in 2012.
Medigene aims to establish one or more partnerships with pharmaceutical or biotechnology companies for EndoTAG®-1. The company envisions the partner or partners taking over the drug candidate's further development and subsequent marketing.
Medigene expects the results of the current formulation study to be available by mid-2012. Based on this, the company plans to continue the clinical development of RhuDex®. The production of additional trial medication is in preparation.
AAVLP Vaccine Technology
Additional preclinical studies will be conducted in 2012 in connection with Medigene's proprietary AAVLP vaccine technology.
The analysts' telephone conference in English will be held today at 3:30 p.m. CEST and will be webcast live. It will be possible to access the synchronized presentation slides and a recording via Medigene's website, www.medigene.com.
The complete 3-months report can be found online under www.medigene.com/reports.
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®, RhuDex® and Veregen® are registered trademarks of Medigene AG. Eligard® is a trademark of Tolmar Therapeutics, Inc. These trademarks may be owned or licensed in select locations only.
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Medigene AG is a publicly listed (Frankfurt: MDG, prime standard) biotechnology company headquartered in Martinsried/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 marketed products, which are distributed by partner companies. It has two drug candidates in clinical trials and is developing an innovative vaccine technology.
Contact Medigene AG
Julia Hofmann, Kerstin Langlotz
Investor & Public Relations
Tel.: +49 - 89 - 20 00 33 - 33 01
Fax: +49 - 89 - 20 00 33 - 29 20
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