Analyst call and webcast (in English) today, 3:30 p.m. (CEST)
Increase in total revenue (from continued operations and discontinued operations) by 18% to EUR 29.6 million (6M 2010: EUR 25.2 million)
Veregen® revenue from product sales and royalties increased by 43%
Positive EBITDA result of EUR 17.0 million (6M 2010: EUR -5.4 million)
Net profit of EUR 14.4 million (6M 2010: Net loss EUR -3.3 million)
Cash and cash equivalents of EUR 15.9 million as of June 30, 2011
(Dec. 31, 2010: EUR 4.8 million)
Confirmation of forecast for the year
Martinsried/Munich, Germany, August 2, 2011. The biotechnology company MediGene AG (Frankfurt, Prime Standard) generated total revenue (from continued operations and discontinued operations) of EUR 29.6 million in the first half of the 2011 fiscal year (6M 2010: EUR 25.2 million). This revenue consists primarily of product sales from the commercialization of the drugs Eligard® and Veregen® and milestone payments of EUR 20.0 million from the transfer of European rights for Eligard® to Astellas. The EBITDA result was positive and totaled EUR 17.0 million (6M 2010: EUR -5.4 million). Net profit for the period was EUR 14.4 million (6M 2010: EUR -3.3 million). Cash and cash equivalents at the end of the reporting period totaled EUR 15.9 million. These results have been prepared under IFRS (International Financial Reporting Standards).
Key events of the first half of 2011:
Conclusion of further partnership agreements for the commercialization of Veregen®:
Laboratoires Expanscience for France
Meditrina for Romania and Bulgaria
Pierre Fabre for Mexico, Central America, Venezuela, and Colombia
Will-Pharma for the Benelux countries
Triton Pharma for Canada
SynCore Bio for Taiwan
Veregen® market approval granted in Spain
Veregen® eligible for insurance reimbursement in Austria since June 2011
Eligard® rights for EU countries transferred to Astellas, payment of EUR 15 million received
AAVLP development partnership agreed with The Johns Hopkins University
Arnd Christ, Chief Financial Officer of MediGene AG commented: "The first half 2011 results presented today reinforce our commitment to and belief in our overall corporate strategy. With the company's financing secured beyond 2012 and our expenses optimized, we will continue to work on strengthening our pipeline both through internal progress and business development activities."
Results of the first half of 2011:
Product sales and other income
MediGene increased total revenue from continued operations by 49% in the first half of 2011 to EUR 1.9 million (6M 2010: EUR 1.3 million). This revenue was generated from Veregen® product sales and royalties in the USA, Germany, and Austria, which increased by 43% to EUR 0.8 million (6M 2010: EUR 0.5 million), and from milestone payments for Veregen® of EUR 0.1 million (6M 2010: EUR 0.7 million). In addition, since March 1, 2011, MediGene has recorded a 2% participation in net sales of Eligard® in continued operations under other income. This line item amounted to EUR 0.9 million.
Revenue from discontinued operations totaled EUR 27.7 million (6M 2010: EUR 23.9 million). Revenue from discontinued operations was generated from European Eligard® product sales, royalties and milestone payments.
EBITDA and net results
In the first half of 2011, MediGene recorded a positive EBITDA result of EUR 17.0 million, compared to EUR -5.4 million for the same period the previous year. Net profit was EUR 14.4 million (6M 2010: EUR -3.3 million). This significant improvement is due primarily to higher revenue. The company has continued to significantly reduce operating expenses compared to the same period of the previous year.
Cash and cash equivalents and average monthly cash flow from operating activities
Cash and cash equivalents totaled EUR 15.9 million as of June 30, 2011 (December 31, 2010: EUR 4.8 million). At the beginning of March, MediGene received a payment of EUR 15 million from the sale of distribution and marketing rights for the cancer drug Eligard® to Astellas.
In the first six months of 2011, the average monthly net cash inflow rate from operating activities amounted to EUR 1.9 million (6M 2010: EUR -1.4 million). Adjusted for the non-recurring items of the milestone payments received from Astellas, the average monthly operating cash burn rate was EUR -0.6 million in the first half of 2011.
Q2 2011 results
Total revenue from continued operations rose by 136% in the second quarter of 2011 to EUR 1.2 million (Q2 2010: EUR 0.5 million). This revenue was generated from Veregen® product sales, royalties and milestone payments. It also includes other operating income, generated mainly from Eligard® product sales since March 2011. Revenue from discontinued operations (Eligard®) in the same period totaled EUR 0.4 million (Q2 2010: EUR 12.6 million). The EBITDA result improved to EUR -2.2 million in the second quarter (Q2 2010:
EUR -3.0 million). The net loss for the second quarter was EUR -2.6 million (Q2 2010: EUR -1.0 million). The increase in the net loss for the period is due to lower revenue sharing for Eligard® as a result of the transfer of rights to Astellas. Cash used by operating activities totaled EUR -3.0 million for the second quarter (Q2 2010: EUR -2.2 million). This corresponds to an average monthly cash burn rate of EUR -1.0 million (Q2 2010: EUR -0.7 million).
|In EUR thousand||Q2 2011||Q2 2010||Change||6M 2011||6M 2010||Change|
| - thereof Veregen® |
product revenue and royalties
|- thereof Veregen® milestones||32||127||-75%||135||680||-80%|
|Other operating income||704||30||>200%||973||43||>200%|
|Total operating expenses||-3,658||-6,086||-40%||-7,411||-12,193||-39%|
|Operating result from continued operations||-2,425||-5,563||-56%||-5,529||-10,928||-49%|
|Result from continued operations||-2,699||-4,760||-43%||-5,803||-10,794||-46%|
|Product sales from discontinued operations||406||12,629||-97%||27,702||23,906||16%|
|Result from discontinued operations||81||3,801||-98%||20,170||7,500||169%|
|Net result for the period||-2,618||-959||173%||14,367||-3,294||>-200%|
Financial Forecast 2011:
MediGene today confirms its financial outlook for the 2011 fiscal year. Based on its present product portfolio, MediGene expects a positive EBITDA result of EUR 10 to 16 million for fiscal year 2011. This result includes non-recurring one-time effects in the form of milestone payments totalling EUR 20 to 25 million for Eligard®, which will also contribute to the total revenue (from continued and discontinued operations) guidance for 2011 of EUR 32 to 38 million.
Since March 1, 2011, MediGene has received a 2% share of net sales revenue from Eligard® generated by Astellas in Europe. The transfer of the rights for non-EU countries is expected to be completed by the end of 2011 or early in 2012, and will lead to a EUR 5 million milestone payment.
MediGene is planning to submit further applications for market approval of Veregen® in additional European countries in 2011. The German market approval will serve as the reference within the scope of the mutual recognition procedure. MediGene also plans to conclude further marketing partnership agreements within and outside of Europe, and has already signed several agreements in the first half of 2011. MediGene expects continued growth in both Veregen® in-market sales and revenue in 2011.
MediGene intends to enter into one or more partnerships for EndoTAG®-1 with pharmaceutical or biotech companies, and envisages the partner or partners taking over further development and future commercialization of the drug candidate.
MediGene is preparing to resume clinical development of RhuDex®. The objective is to initiate a phase I clinical trial in 2011, in which a new formulation customized for treatment of chronic conditions will be tested and optimized.
As part of its collaboration with The Johns Hopkins University, additional pre-clinical trials will be carried out in 2011 in order to test the first vaccine candidates of the AAVLP platform for the prevention of HPV-associated cancers.
An analyst call (in English) and webcast will be held today at 3:30 p.m CEST. The webcast with synchronized slide presentation can be accessed via MediGene's website: www.medigene.com. A recording of the presentation will be made available following the live webcast.
The complete quarterly report is available online at www.medigene.com/media-investors/reports-presentations/.
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 registered 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 is the first German biotech company to have revenues from marketed products. It has various drug candidates in clinical development and possesses innovative platform technologies. MediGene focuses on clinical research and development of novel drugs against cancer and autoimmune diseases.
Contact MediGene AG
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Tel.: +49 - 89 - 85 65 - 33 01
Fax: +49 - 89 - 85 65 - 29 20