Genmab 2012 Annual Report


07.03.13 17:05
Meldung
 
Below is a summary from the report of businessprogress and financial performance for the year and financial outlook for 2013.The full report is attached in PDF form or can be found on the investor sectionof the company's website, www.Genmab.com. IMPRESSIVE 2012 ACHIEVEMENTSBusiness ProgressMaximizing the Value of Ofatumumab> Reported Phase II data in fludarabine and alemtuzumab refractorychronic lymphocytic leukemia (CLL) at American Society of Clinical Oncology(ASCO) meeting > Independent Data Monitoring Committee (IDMC) recommended continuingPhase III study of ofatumumab plus chemotherapy versus rituximab pluschemotherapy in diffuse large B-cell lymphoma (DLBCL) following interimanalysis > Data from 11 Investigator Sponsored Studies (ISS) presented at threemajor medical conferences o Amended protocol for Phase III head-to-head DLBCL study, bringing timelineforward by one year o Completed patient enrollment in Phase III study of ofatumumab incombination with fludarabine and cyclophosphamide (FC) vs FC in patients withrelapsed CLL o Initiated new Phase I/II study of ofatumumab plus chlorambucil inpreviously untreated Japanese patients with CLL o Completed patient enrollment in Phase II study of ofatumumab incombination with bendamustine for treatment of front line and relapsed CLL o Completed patient enrollment in Phase IV observational study in CLLo Presented Phase II follicular lymphoma (FL) data at American Society ofHematology (ASH) meeting x Phase III CLL maintenance safety interim data analysis expected H12013, no impact on trial timeline Expansion of Arzerra(r)> First launch in South America; launched in 26 countries by end of2012 > GlaxoSmithKline (GSK) submitted New Drug Application (NDA) in Japano GSK sales increased in British pounds by 38%, resulting in DKK 111 millionin royalty income to Genmab Advancing Daratumumab> Reported efficacy data from Phase I/II study in refractory multiplemyeloma > Initiated Phase I/II study of daratumumab in combination withRevlimid > Entered partnership agreement with Janssen Biotech, Inc., one of theJanssen Pharmaceutical Companies Expanding Our Pipeline> Presented proof-of-concept for DuoBody(r) technology platform> Presented proof-of-concept for HuMax(r)-TF-ADCProgressing Next Generation Technologies> Entered DuoBody Platform collaborations with Novartis, Janssen andKyowa Hakko Kirin > Janssen activated three DuoBody programs; achieved technicalproof-of-concept milestone o Unveiled proprietary HexaBody(tm) technology platformDriving Value through Collaborations> Achieved second and third pre-clinical milestones in Lundbeckcollaboration > Outlicensed HuMax-IL8 to Cormorant Pharmaceuticalsx Progress on partnered clinical programs not yet reportedManage and Control Cash Burn> Reduced cash burn & lengthened cash runway> Improved loss from continuing operations three timesx Wrote down value of manufacturing facility in 2012, sale executed inQ1 2013 Financial Performanceo Revenue increased by DKK 134 million, 38%, from DKK 351 million in 2011 toDKK 485 million, mainly due to revenue related to our daratumumab and DuoBodycollaborations with Janssen, higher Arzerra royalties, and a milestone paymentfrom GSK. o As the opeRating expenses remained at the same level as 2011, theoperating loss improved by DKK 132 million, or 53%, from DKK 249 million in2011 to DKK 117 million in 2012. o Due to continued uncertainty, we wrote down the value of the facility fromUSD 58 million to zero, which resulted in the recognition of a non-cashimpairment charge of approximately DKK 331 million. o 2012 year end cash position of DKK 1,516 million, compared to DKK 1,105million as of December 31, 2011. The improvement was driven by the proceeds ofapproximately DKK 800 million received from the daratumumab deal, partiallyoffset by the ongoing investment in our research and development activities. > = Stated objective meto = Other achievementx = Stated objective not met2013 OUTLOOKMDKK 2013 2012 Actual Guidance Result --------------------------------Revenue 540 - 580 485 --------------------------------Operating expenses (600) - (602) (650) --------------------------------Operating loss continuing operations (40) - (90) (117) --------------------------------Discontinued operation 40 (376) --------------------------------Cash position beginning of year* 1,516 1,105 --------------------------------Cash used in operations (250) - (389) (300) --------------------------------Cash from license & share subscription - 800 agreement --------------------------------MN facility sale 50 - --------------------------------Cash position at end of year* 1,266 - 1,516 1,316 --------------------------------*Cash, cash equivalents, and marketable securities --------------------------------- Conference CallGenmab will hold a conference call in English to discuss the results for thefull year 2012 today, Thursday, March 7, at 6:00pm CET, 5:00pm GMT or 12:00pmEST. The dial in numbers are: +1 866 682 8490 (US participants) and ask for the Genmab conference call+44 1452 555131 (international participants) and ask for the Genmab conferencecall A live and archived webcast of the call and relevant slides will be availableat www.genmab.com. About Genmab A/SGenmab is a publicly traded, international biotechnology company specializingin the creation and development of differentiated human antibody therapeuticsfor the treatment of cancer. Founded in 1999, the company's first marketedantibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocyticleukemia in patients who are refractory to fludarabine and alemtuzumab afterless than eight years in development. Genmab's validated and next generationantibody technologies are expected to provide a steady stream of future productcandidates. Partnering of innovative product candidates and technologies is akey focus of Genmab's strategy and the company has alliances with top tierpharmaceutical and biotechnology companies. For more information visitwww.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.comThis Company Announcement contains forward looking statements. The words'believe', 'expect', 'anticipate', 'intend' and 'plan' and similar expressionsidentify forward looking statements. Actual results or performance may differmaterially from any future results or performance expressed or implied by suchstatements. The important factors that could cause our actual results orperformance to differ materially include, among others, risks associated withpre-clinical and clinical development of products, uncertainties related to theoutcome and conduct of clinical trials including unforeseen safety issues,uncertainties related to product manufacturing, the lack of market acceptanceof our products, our inability to manage growth, the competitive environment inrelation to our business area and markets, our inability to attract and retainsuitably qualified personnel, the unenforceability or lack of protection of ourpatents 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 therisk management sections in Genmab's most recent financial reports, which areavailable on www.genmab.com. Genmab does not undertake any obligation to updateor revise forward looking statements in this Company Announcement nor toconfirm such statements in relation to actual results, unless required by law. Genmab A/S and its subsidiaries own the following trademarks: Genmab(r); theY-shaped Genmab logo(r); HuMax(r); HuMax-CD20(r); DuoBody(r), HexaBody(TM) andUniBody(r). Arzerra(r) is a trademark of GlaxoSmithKline. Company Announcement no. 06CVR no. 2102 3884Genmab A/SBredgade 34E1260 Copenhagen KDenmarkClick on, or paste the following link into your web browser, to view the associated documentshttps://newsclient.omxgroup.com/cds/DisclosureAttachmentServlet?messageAttachmentId=422152News Source: NASDAQ OMX07.03.2013 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--------------------------------- Language: EnglishCompany: Genmab A/S DänemarkPhone: Fax: E-mail: Internet: ISIN: DK0010272202WKN: End of Announcement DGAP News-Service ---------------------------------


 

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