Martinsried/Munich, November 7, 2008. Today MediGene AG (Frankfurt, Prime Standard: MDG) has published is 9-Months Report 2008. During this period, MediGene increased total revenues by 37 % to Euro 25.5 million and significantly improved its EBITDA (earnings before interest, tax, foreign currency gains/losses, depreciation and amortization) to Euro -19.5 million (9M-2007: Euro -22.2 million). Earnings before interest and tax (EBIT) include a one-time depreciation of Euro 6.4 million, and totals Euro -26.8 million (9M-2007: Euro -23.2 million). The result for the period amounts to Euro -25.0 million. For the full financial year 2008, MediGene expects revenues to total approx. Euro 38 million compared to last year’s Euro 24 million. The loss on EBITDA basis is expected to decrease significantly, to Euro -26 million compared to 2007 (Euro -30 million).
Major events in the first nine months of 2008:
• MediGene obtained very good efficacy and safety data of EndoTAG(TM)-1 in phase II study in pancreatic cancer
• Medigene announced strategic focus on oncology and immunology
• European marketing authorization granted for Oracea®
• MediGene sold European marketing rights to Oracea® to Galderma Laboratories Inc. European market launch of the six-months product of Eligard® largely completed
• Successfully completed a phase IIa pilot study with RhuDex(TM) for the treatment of rheumatoid arthritis
• Phase I study with new formulation of RhuDex(TM) placed on hold
• MediGene exercised option on anti-L1 antibody for cancer therapy, and continues collaboration with the DKFZ (German Cancer Research Center)
Dr Thomas Klaue, Chief Financial Officer of MediGene AG, comments: “In the first nine months of 2008, we have significantly advanced the business. The excellent phase II results obtained with EndoTAG(TM)-1 gave cause for us to focus the company on our core areas oncology and immunology. Material steps in this direction have already been taken through the sale of Oracea® and the spin-off of the mTCR program. Thereby we have created significant cost-saving potential, which make its full impact through 2009. Driven by the clinical data from EndoTAG(TM)-1 we are very confident that we will be able to conclude a strategic partnership next year. In cooperation with a partner we intend to further develop and commercialize this attractive drug candidate with its numerous potential fields of application.”
Financial Result 9-Months 2008
in T Euro Q3-2008 Q3-2008 Change 9M-2008 9M-2007 Change
Total revenues 11,742 6,151 91 % 25,510 18,605 37 %
Cost of sales -6,039 -4,541 33 % -16,012 -14,181 13 %
Gross profit 5,703 1,610 >200 % 9,498 4,424 115 %
Selling, general, and administrative expenses -2,378 -2,052 16 % -8,180 -6,836 20 %
Research and development expenses -6,559 -7,068 -7 % -21,684 -20,788 4 %
EBITDA -3,041 -7,181 -58 % -19,518 -22,155 -12 %
Impairment mTCR -6,384 - - -6,384 - -
Operating result (EBIT) -9,618 -7,510 28 % -26,750 -23,200 15 %
Result before tax -9,058 -7,371 23 % -26,650 -22,280 20 %
Net loss for the period -8,402 -7,249 16 % -24,994 -20,041 25 %
Financial result of the first nine months and the third quarter of 2008:
Total revenues totalled 25,510 T Euro in the first nine months of 2008, (9M-2007: 18,605 T Euro), and 11,742 T Euro in the third quarter of 2008 (Q3-2007: 6,151 T Euro). Revenues have been generated almost exclusively from the commercialization of Eligard® in Europe. MediGene also received research grants and payments from cooperation partners.
Compared to last year’s reporting period, general, administrative, and selling expenses increased by 20 % to 8,180TEuro (9M-2007: 6,836 T Euro) and by 16 % to 2,378 T Euro in the third quarter of 2008 (Q3-2007: 2,052 T Euro). This increase is mainly due to increased marketing expenses, to the cost for the preparation of a prospectus for the admission to trading of shares already issued, and to the increased expenses for employees’ stock options in 2008 according to IFRS2.
In the first nine months of 2008, R&D expenses increased by 4 % to 21,684 T Euro (9M-2007: 20,788 T Euro). In the third quarter 2008 they decreased by 7 % to 6,559 T Euro (Q3-2007: 7,068 T Euro).
MediGene has today introduced EBITDA as a new figure into its reporting. MediGene uses the term EBITDA as earnings before interest, tax, foreign currency gains/losses, and depreciation of fixed and intangible assets. As a cash-flow-related parameter, EBITDA possesses a higher operational significance than EBIT. Therefore the operating result (EBIT) which, for example, is impacted in the reporting period Q3/2008 due to an impairment in the course of the mTCR spin-off, does not allow a reasonable comparison with the previous reporting periods. This change of focus to EBITDA is expected to improve the comparability of actual operating results before depreciation and special items in the individual reporting periods.
The loss on an EBITDA basis decreased by 12 % to 19,518 T Euro (9M-2007: 22,155 T Euro) in the first nine months, and by 58 % to 3,041 T Euro in the third quarter (Q3-2007: 7,181 T Euro), since there was a significant impact by the sale of the European marketing rights to Oracea® to Galderma.
Depreciation increased to 7,232 T Euro in the first nine months of 2008 (9M-2007: 1,045 T Euro), and to 6,577 T Euro in the third quarter of 2008 (Q3-2007: 329 T Euro). This severe increase is due to the one-time impairment of value according to IAS 36 of the mTCR platform which was spun out into Immunocore Ltd.
Cash used by operating activities decreased to 22,959 T Euro in the first nine months of 2008 (9M-2007: 26,238 T Euro), and to 7,774 T Euro in the third quarter of 2008 (Q3-2007: 7,916 T Euro). The difference between the net loss for the period and the cash outflow in the first nine months of 2008 is mainly a consequence of the impairment referring to the mTCR platform that does not affect cash, which became effective as a result of the sale of assets to Immunocore Ltd.
The average monthly net cash burn rate from operating activities was approx. Euro 2.5 million in the first nine months of 2008 (9M-2007: Euro 2.9 million ), and of Euro 2.6 million in the third quarter of 2008 (Q3-2007: Euro 2.6 million).
During the first nine months of 2008 net cash flow from investing activities amounted to 4,400 T Euro (9M-2007: -466 T Euro), and to 4,627 T Euro in the third quarter of 2008 (Q3-2007: -167 T Euro). The net cash inflow results from the sale for the European marketing rights to Oracea® to Galderma, the proceeds of which totalled Euro 8 million, as well as an investment of Euro 3.3 million in the Immunocore Ltd. stake.
At September 30, 2008, cash and cash equivalents totalled 29,845 T Euro.
Financial forecast 2008:
Early in 2008, MediGene predicted a significant increase in total revenues and a reduction of the loss on EBIT basis for the financial year 2008. MediGene now expects a significant increase in total revenues to approx. Euro 38 million, compared to last year’s Euro 24 million. These revenues will be generated by product sales of Eligard®, and by proceeds from the sale of the European marketing rights to Oracea®. Operational costs will increase slightly compared to the financial year 2007 due to increased R&D expenses resulting from the extended activities around our product candidates EndoTAG(TM)-1 and RhuDex(TM). Except for impairment due to the spin-off of the mTCR technology, MediGene expects a decrease in loss on an EBIT basis compared to last year. Using EBITDA as the comparator, MediGene expects a significantly improved result of Euro -26 million compared to last year (Euro -30 million).
Analyst Conference call with webcast: MediGene will present the Q3-2008 earnings in a conference call to analysts and investors alongside a live webcast. The call will be held in English and starts today at 2pm CEST, 1pm BST and 8am EDT.
Access to the webcast, including synchronized slides, will be available on the MediGene website at www.medigene.com. Following the live presentation, a replay will also be available.
The detailed Nine-Months Report 2008 of MediGene AG is available on the internet at http://www.medigene.de/deutsch/quartalsberichte.php
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 statements made herein. MediGene is not bound to update any of these forward-looking statements. MediGene®, EndoTAG(TM) and EndoTAG(TM)-1 are registered trademarks of MediGene AG. Oracea® is a registered trademark of CollaGenex Pharmaceuticals, Inc. Eligard® is a registered trademark of QLT USA, Inc. RhuDex(TM) is a trademark of MediGene Ltd. These trademarks may be owned or licensed in select locations only.
