Genmab A/S 15.08.2012 17:02
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August 15, 2012; Copenhagen, Denmark; Interim Report for the First Half 2012 -- DuoBody(tm) collaborations signed with Novartis and Janssen Biotech -- Daratumumab preliminary safety and efficacy data presented at ASCO and EHA -- Arzerra(r) first half net sales increased 37% over prior year -- 2012 guidance improved and H1 operating result and cash burn improved by 36% over 2011 'During the second quarter we were pleased to see further increases in Arzerra sales, promising early data from our daratumumab program presented at two prestigious cancer conferences and improvements in our operating result, cash burn and full year guidance. The highlight for the quarter though, was the signing of two DuoBody agreements with Novartis and Janssen Biotech which are potentially worth over USD 1.9 billion in milestone payments. These deals further validate the value and potential of our bispecific technology platform. We are delighted to see our strategy evolving into tangible results,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half -- Genmab's revenues were DKK 206 million for the first half of 2012 compared to DKK 167 million for the corresponding period in 2011. The increase of DKK 39 million or 23% was mainly driven by higher Arzerra royalties and the achievement of a milestone under our collaboration with GlaxoSmithKline (GSK). -- Operating expenses decreased 2% from DKK 294 million in the first half of 2011 to DKK 287 million in the first half of 2012. -- An operating loss of DKK 82 million in the first half of 2012 compared to DKK 127 million in the corresponding period for 2011, an improvement of 36%. The improved operating result was driven by increased revenues, and continued strong focus on cost control. -- On June 30, 2012, Genmab had a cash position of DKK 952 million resulting in a cash burn of DKK 153 million in the first half of 2012. This was a reduction of DKK 85 million or 36% compared to the corresponding period in 2011. Business Progress Second Quarter to Present -- April: GSK submitted a New Drug Application (NDA) for ofatumumab to regulatory authorities in Japan for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received prior treatment. This filing triggered a milestone payment of DKK 20 million in May. -- May/June: Preliminary safety and efficacy data from the daratumumab Phase I/II study in multiple myeloma were presented at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) meetings. -- June: Genmab entered a DuoBody technology collaboration with Novartis to create and develop bispecific antibodies. Genmab received an upfront payment of USD 2 million, and the total potential value of the agreement would be approximately USD 175 million, if all milestones are met, plus research funding and royalties. -- July: Genmab entered into a collaboration with Janssen Biotech to create and develop bispecific antibodies for up to 10 programs using its DuoBody technology platform. Genmab received an upfront payment of USD 3.5 million. Genmab will potentially be entitled to milestone and license payments of up to approximately USD 175 million per program, if all milestones are met, plus research funding and royalties. -- July : GSK reported net sales for Arzerra for the second quarter of 2012 of GBP 14.9 million, an increase of 42% over Q2 2011, resulting in royalty income of DKK 27 million to Genmab. Outlook Genmab is improving its 2012 financial guidance. The revenue and operating result are improved and cash burn is reduced, mainly as a result of the inclusion of income from DuoBody collaborations. Conference Call Genmab will hold a conference call in English to discuss the results for the first half of 2012 today, Wednesday, August 15, at 6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are: +1 718 354 1226 (US participants) and ask for the Genmab conference call +44 207 509 5139 (international participants) and ask for the Genmab conference call A live and archived webcast of the call and relevant slides will be available at www.genmab.com. To read the full PDF version of the Interim Report for the First Half 2012, visit Genmab's website at http://ir.genmab.com/annuals.cfm. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com This interim report contains forward looking statements. The words 'believe', 'expect', 'anticipate', 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section 'Risk Management' in Genmab's annual report, which is available on www.genmab.com and the 'Significant Risks and Uncertainties' section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law. Genmab(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); HuMax(r)-EGFr; HuMax(r)-IL8; HuMax(r)-TAC; HuMax(r)-CD38; HuMax(r)-TF; HuMax(r)-TF-ADC; HuMax(r)-Her2; HuMax(r)-cMet, HuMax(r)-CD74, DuoBody(tm) and UniBody(r) are all trademarks of Genmab A/S. Arzerra(r) is a trademark of GlaxoSmithKline. Company Announcement no. 19 CVR no. 2102 3884 Genmab A/S Bredgade 34 1260 Copenhagen K Denmark Click on, or paste the following link into your web browser, to view the associated documents https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=400722 News Source: NASDAQ OMX 15.08.2012 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English Company: Genmab A/S Denmark Phone: Fax: E-mail: Internet: ISIN: DK0010272202 WKN: End of Announcement DGAP News-Service
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August 15, 2012; Copenhagen, Denmark; Interim Report for the First Half 2012 -- DuoBody(tm) collaborations signed with Novartis and Janssen Biotech -- Daratumumab preliminary safety and efficacy data presented at ASCO and EHA -- Arzerra(r) first half net sales increased 37% over prior year -- 2012 guidance improved and H1 operating result and cash burn improved by 36% over 2011 'During the second quarter we were pleased to see further increases in Arzerra sales, promising early data from our daratumumab program presented at two prestigious cancer conferences and improvements in our operating result, cash burn and full year guidance. The highlight for the quarter though, was the signing of two DuoBody agreements with Novartis and Janssen Biotech which are potentially worth over USD 1.9 billion in milestone payments. These deals further validate the value and potential of our bispecific technology platform. We are delighted to see our strategy evolving into tangible results,' said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Financial Performance First Half -- Genmab's revenues were DKK 206 million for the first half of 2012 compared to DKK 167 million for the corresponding period in 2011. The increase of DKK 39 million or 23% was mainly driven by higher Arzerra royalties and the achievement of a milestone under our collaboration with GlaxoSmithKline (GSK). -- Operating expenses decreased 2% from DKK 294 million in the first half of 2011 to DKK 287 million in the first half of 2012. -- An operating loss of DKK 82 million in the first half of 2012 compared to DKK 127 million in the corresponding period for 2011, an improvement of 36%. The improved operating result was driven by increased revenues, and continued strong focus on cost control. -- On June 30, 2012, Genmab had a cash position of DKK 952 million resulting in a cash burn of DKK 153 million in the first half of 2012. This was a reduction of DKK 85 million or 36% compared to the corresponding period in 2011. Business Progress Second Quarter to Present -- April: GSK submitted a New Drug Application (NDA) for ofatumumab to regulatory authorities in Japan for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received prior treatment. This filing triggered a milestone payment of DKK 20 million in May. -- May/June: Preliminary safety and efficacy data from the daratumumab Phase I/II study in multiple myeloma were presented at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) meetings. -- June: Genmab entered a DuoBody technology collaboration with Novartis to create and develop bispecific antibodies. Genmab received an upfront payment of USD 2 million, and the total potential value of the agreement would be approximately USD 175 million, if all milestones are met, plus research funding and royalties. -- July: Genmab entered into a collaboration with Janssen Biotech to create and develop bispecific antibodies for up to 10 programs using its DuoBody technology platform. Genmab received an upfront payment of USD 3.5 million. Genmab will potentially be entitled to milestone and license payments of up to approximately USD 175 million per program, if all milestones are met, plus research funding and royalties. -- July : GSK reported net sales for Arzerra for the second quarter of 2012 of GBP 14.9 million, an increase of 42% over Q2 2011, resulting in royalty income of DKK 27 million to Genmab. Outlook Genmab is improving its 2012 financial guidance. The revenue and operating result are improved and cash burn is reduced, mainly as a result of the inclusion of income from DuoBody collaborations. Conference Call Genmab will hold a conference call in English to discuss the results for the first half of 2012 today, Wednesday, August 15, at 6.00 pm CEST, 5.00 pm BST or noon EDT. The dial in numbers are: +1 718 354 1226 (US participants) and ask for the Genmab conference call +44 207 509 5139 (international participants) and ask for the Genmab conference call A live and archived webcast of the call and relevant slides will be available at www.genmab.com. To read the full PDF version of the Interim Report for the First Half 2012, visit Genmab's website at http://ir.genmab.com/annuals.cfm. About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com. Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com This interim report contains forward looking statements. The words 'believe', 'expect', 'anticipate', 'intend' and 'plan' and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section 'Risk Management' in Genmab's annual report, which is available on www.genmab.com and the 'Significant Risks and Uncertainties' section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law. Genmab(r); the Y-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); HuMax(r)-EGFr; HuMax(r)-IL8; HuMax(r)-TAC; HuMax(r)-CD38; HuMax(r)-TF; HuMax(r)-TF-ADC; HuMax(r)-Her2; HuMax(r)-cMet, HuMax(r)-CD74, DuoBody(tm) and UniBody(r) are all trademarks of Genmab A/S. Arzerra(r) is a trademark of GlaxoSmithKline. Company Announcement no. 19 CVR no. 2102 3884 Genmab A/S Bredgade 34 1260 Copenhagen K Denmark Click on, or paste the following link into your web browser, to view the associated documents https://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=400722 News Source: NASDAQ OMX 15.08.2012 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement. DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English Company: Genmab A/S Denmark Phone: Fax: E-mail: Internet: ISIN: DK0010272202 WKN: End of Announcement DGAP News-Service
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