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Key financials improved significantly in 2009 Important development and commercialization milestones met in 2009 Expect revenue growth and similar earnings in 2010
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Company Information/Molecular diagnostics
Subtitle: Key financials improved significantly in 2009
Important development and commercialization milestones met in 2009
Expect revenue growth and similar earnings in 2010
Press release, Berlin, Germany, and Seattle, WA, USA, April 19, 2010 (euro adhoc) - Epigenomics AG (Frankfurt Prime Standard: ECX), a cancer molecular diagnostics company, today hosted its Annual Press Conference and Analyst Meeting in Frankfurt/ Main. Geert Nygaard, CEO, and Oliver Schacht, CFO, informed on the results of the fiscal year 2009, reported on key highlights and provided an outlook on the company's business activities and expectations for 2010 and beyond.
Geert Nygaard, CEO of Epigenomics commented:"Delivering on our promises and meeting all our key development and commercialization milestones in 2009 and early 2010 such as the launches of Epi proColon, Abbott's Real Time mS9 Colorectal Cancer Assay, Quest's ColoVantage test service as well as the successful completion of our PRESEPT study have ideally positioned Epigenomics for the commercial phase in our corporate development."
Oliver Schacht, CFO of Epigenomics added: "With the successful closing of our oversubscribed public rights offering in Q1-2010 that yielded gross proceeds of EUR 33.1 million we are well funded to execute our product development programs and drive commercialization of our products."
Key Financials 2009
In 2009, Epigenomics grew its total revenue to EUR 4.3 million; a significant increase of 65% compared to EUR 2.6 million in 2008.
Cost of sales increased significantly from EUR 1.7 million to EUR 2.8 million as a result of increased collaboration-driven product development expenses and especially due to the acquisition of clinical samples under Epigenomics' collaboration with Abbott.
Other income decreased to EUR 0.5 million in 2009 from EUR 1.1 million in 2008, when high income from a one-time reversal of provisions had affected the total number.
In 2009, R&D costs have decreased significantly by approximately EUR 2.7 million from EUR 10.0 million in 2008 to EUR 7.3 million at the end of 2009.
Marketing and business development costs significantly increased by 39% from EUR 0.9 million in 2008 to EUR 1.2 million in 2009, as a result of increased pre-marketing, sales and technical support activities for the launch of Epigenomics' Epi proColon colorectal cancer blood test.
In 2009, EBIT amounted to EUR -10.2 million, a significant improvement of 20% compared to previous year's EUR -12.8 million as a result of our strict fiscal discipline coupled with solid revenue growth.
Cash flow from operations was EUR -10.6 million for 2009 versus EUR -9.8 million for 2008.
As of December 31, 2009, the company's financial position including marketable securities showed a total liquidity amounting to EUR 6.1 million (31.12.2008: EUR 12.1 Mio.).
On March 30, 2010, Epigenomics successfully completed the placement of 14,697,361 new ordinary bearer shares within a rights offering representing the entire authorized capital available. The new shares were placed at the subscription price of EUR 2.25 per new share resulting in gross proceeds of about EUR 33.1 million. With the registration of the capital increase on March 31 2010 the total issued share capital of Epigenomics has increased from EUR 29,394,724.00 to EUR 44,092,085.00. ICF Kursmakler AG (Frankfurt, Germany) acted as sole lead manager and sole underwriter and Trout Capital LLC (New York, NY, U.S.A.) acted as placement agent to Epigenomics in the U.S.
Key Highlights 2009/2010
Following the launch of Epi proColon as a CE-marked IVD product in Europe in October 2009 Epigenomics has grown its laboratory customer base from a handful in Q4-2009 to 18 customer laboratories in Germany and Switzerland as of today, including synlab with its 55 German sites, one of Europe's largest laboratory networks.
2009 and early 2010 have been characterized by continued focus on Epigenomics' commercialization of the lead product Epi proColon. Enrollment into the PRESEPT Study was completed successfully and substantial progress has been made in the company's product development pipeline especially the lung cancer program.
During 2009 and into 2010, Epigenomics' R&D activities have continued to focus on executing the PRESEPT Study. After the release of preliminary data in January 2010, Epigenomics reported updated top-line PRESEPT Study data on March 8, 2010 showing that the Septin9 biomarker in this academic medicine study detected colorectal cancer cases with a sensitivity of approximately 63% and a specificity of around 89%.
During 2009 Epigenomics continued executing its non-exclusive partnering and commercialization strategy by entering into new collaboration agreements regarding the Septin9 biomarker for colorectal cancer with the Japanese IVD company Sysmex Corp. and the U.S. Reference Laboratory ARUP Laboratories in Salt Lake City, UT. Further deals were signed with Quest Diagnostics and Predictive Biosciences for a laboratory-developed prostate cancer test.
Moving forward in transforming the company into a fully integrated molecular diagnostics company Epigenomics has made significant progress. The company obtained ISO 13485 certification in 2009 enabling it to develop, manufacture and market IVD products. Throughout 2009 Epigenomics has made substantial progress in its lung cancer product development program. After the successful clinical evaluation of the mSHOX2 biomarker in bronchial lavage specimen from patients with suspected lung cancer in Q1-2009, Epigenomics initiated the formal product development of an IVD test for lung cancer.
Outlook for 2010 and beyond
Epigenomics intends to build on the successful year 2009 as well as the very promising start into 2010 with EUR 33.1 million gross proceeds from the recently completed financing transaction to complete the transformation into an integrated molecular diagnostics industry player. Focus will be on the commercial execution together with partners and licensees as well as driving direct product sales in the home markets. To that end Epigenomics expects to grow the marketing and sales team in Europe by a handful of key additions and new hires.
The company anticipates commercial traction of all Septin9-based tests that are commercially available to increase gradually during 2010 and to accelerate in 2011 and beyond. The management expects direct product sales of the Epi proColon test in Germany, Switzerland and Austria as well as distributor sales in other key European markets to add to revenue growth. Furthermore Epigenomics expects to maintain a solid base of R&D collaboration, licensing and partnering based revenue generation at similar levels to the previous years, which assumes the closing of one additional IVD partnership in 2010. Royalty income from sales of Abbott's RealTime mS9 Colorectal Cancer product and Quest's ColoVantage? testing service should also gradually start to contribute in 2010 with accelerated growth expected in 2011 and beyond. The expected launch of ARUP's Septin9 testing service in 2010 should add to the royalty income going forward.
On the product development and pipeline progress Epigenomics' management awaits the launch of the CE marked Epi proLung BL Reflex Assays by midyear 2010. In line with the commercial strategy in colorectal cancer the company intends to market and sell directly in home markets and work with distributors in other countries. It also plans to initiate a clinical trial for regulatory approval of the Epi proColon test using the PRESEPT cohort in 2010 with a view to obtaining such regulatory approval in the USA ideally still in 2011. Epigenomics also expect its partner Abbott to complete its clinical trial for regulatory approval of the Abbott RealTime mS9 Colorectal Cancer test and to seek such regulatory approval for the U.S. by 2011.
R&D going forward will focus on enhancement and expansion of Epi proColon product. As an example, the company has recently launched an updated version of the product which can now be used on two real-time PCR devices, the Roche LightCycler? 480 and AB7500 Fast Real Time PCR System. Further R&D in the colorectal cancer program focuses on enhanced clinical characteristics for colorectal cancer early detection as well as expansion of the clinical utility into disease monitoring and adenoma detection. Lung cancer test development will take second priority with prostate cancer taking third priority and requiring current and future partners to commercialization.
Financials for the fiscal year 2010 are expected to be characterized by continued fiscal discipline and focus on commercialization. Epigenomics anticipates 2010 revenue of at least EUR 5 million, with the potential to double in each of the following two years towards achieving profitability by the end of 2012 at the earliest. This will depend on successful commercialization of own products as well as current and new partners being successful in their test commercialization. 2010 EBIT is expected to be similar to 2009 with a target of around EUR -10 million for the fiscal year 2010. Cash burn will be closely monitored and is expected remain around EUR 10 million for 2010 despite the completion of PRESEPT and the lung cancer IVD development, as marketing and sales spending will increase. Further, the Company expects to fund a clinical trial and a filing for regulatory approval in the U.S. in 2010 and 2011 before eventually commercializing a regulatory approved Epi proColon product in the U.S.
The annual report 2009 is available at Epigenomics' website at: http: //www.epigenomics.com/en/investor_relations/Financial_Information/
An Analyst Conference Call will be hosted by Epigenomics' management today at 3 pm (CET)/ 9 am (EST). The conference call will be conducted in English.
Dial-in number (within Germany.): +49 (0) 69 247 501 899 Dial-in number (outside Germany): +1 212 444 0297
Please dial-in at least 10 minutes prior to the start of the call.
To follow the presentation, we kindly ask all participants of the call to download the slide set from the company website prior to the call where it will be made available as a PDF file today at 12 pm CET (5 am EST) on the same day via: www.epigenomics.com/en/down_loads/corporate_material/
The conference call will be recorded and also made available on the company website web as a audio file after the call. Please go to: www.epigenomics.com/en/down_loads/corporate_material/
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests on the market and in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
Epigenomics' product portfolio contains the CE-marked IVD test Epi proColon, the world's first regulatory cleared molecular diagnostic test for the detection of colorectal cancer in blood that is based on the biomarker Septin9, and further proprietary DNA methylation biomarkers and IVD products at various stages of development for colorectal, lung and prostate cancer. For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, and ARUP Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, U.S.A. For more information, please visit Epigenomics' website at www.epigenomics.com.
Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale in the United States. The analytical and clinical performance characteristics of any product based on this technology which may be sold at some future time in the U.S. have not been established.
end of announcement euro adhoc --------------------------------------------------------------------------------
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