Copenhagen, Denmark; March 7, 2013 – Genmab A/S (OMX: GEN) today published its Annual Report for 2012. Below is a summary from the report of business progress 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 section of the company’s website, www.genmab.com.
IMPRESSIVE 2012 ACHIEVEMENTS
Maximizing the Value of Ofatumumab
› Reported Phase II data in fludarabine and alemtuzumab refractory chronic lymphocytic leukemia (CLL) at American Society of Clinical Oncology (ASCO) meeting
› Independent Data Monitoring Committee (IDMC) recommended continuing Phase III study of ofatumumab plus chemotherapy versus rituximab plus chemotherapy in diffuse large B-cell lymphoma (DLBCL) following interim analysis
› Data from 11 Investigator Sponsored Studies (ISS) presented at three major medical conferences
o Amended protocol for Phase III head-to-head DLBCL study, bringing timeline forward by one year
o Completed patient enrollment in Phase III study of ofatumumab in combination with fludarabine and cyclophosphamide (FC) vs FC in patients with relapsed CLL
o Initiated new Phase I/II study of ofatumumab plus chlorambucil in previously untreated Japanese patients with CLL
o Completed patient enrollment in Phase II study of ofatumumab in combination with bendamustine for treatment of front line and relapsed CLL
o Completed patient enrollment in Phase IV observational study in CLL
o Presented Phase II follicular lymphoma (FL) data at American Society of Hematology (ASH) meeting
× Phase III CLL maintenance safety interim data analysis expected H1 2013, no impact on trial timeline
Expansion of Arzerra®
› First launch in South America; launched in 26 countries by end of 2012
› GlaxoSmithKline (GSK) submitted New Drug Application (NDA) in Japan
o GSK sales increased in British pounds by 38%, resulting in DKK 111 million in royalty income to Genmab
› Reported efficacy data from Phase I/II study in refractory multiple myeloma
› Initiated Phase I/II study of daratumumab in combination with Revlimid
› Entered partnership agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies
Expanding Our Pipeline
› Presented proof-of-concept for DuoBody® technology platform
› Presented proof-of-concept for HuMax®-TF-ADC
Progressing Next Generation Technologies
› Entered DuoBody Platform collaborations with Novartis, Janssen and Kyowa Hakko Kirin
› Janssen activated three DuoBody programs; achieved technical proof-of-concept milestone
o Unveiled proprietary HexaBody™ technology platform
Driving Value through Collaborations
› Achieved second and third pre-clinical milestones in Lundbeck collaboration
› Outlicensed HuMax-IL8 to Cormorant Pharmaceuticals
× Progress on partnered clinical programs not yet reported
Manage and Control Cash Burn
› Reduced cash burn & lengthened cash runway
› Improved loss from continuing operations three times
× Wrote down value of manufacturing facility in 2012, sale executed in Q1 2013
o Revenue increased by DKK 134 million, 38%, from DKK 351 million in 2011 to DKK 485 million, mainly due to revenue related to our daratumumab and DuoBody collaborations with Janssen, higher Arzerra royalties, and a milestone payment from GSK.
o As the operating expenses remained at the same level as 2011, the operating loss improved by DKK 132 million, or 53%, from DKK 249 million in 2011 to DKK 117 million in 2012.
o Due to continued uncertainty, we wrote down the value of the facility from USD 58 million to zero, which resulted in the recognition of a non-cash impairment charge of approximately DKK 331 million.
o 2012 year end cash position of DKK 1,516 million, compared to DKK 1,105 million as of December 31, 2011. The improvement was driven by the proceeds of approximately DKK 800 million received from the daratumumab deal, partially offset by the ongoing investment in our research and development activities.
› = Stated objective met
o = Other achievement
× = Stated objective not met
|MDKK||2013 Guidance||2012 Actual Result|
|Revenue||540 – 580||485|
|Operating expenses||(600) – (650)||(602)|
|Operating loss continuing operations||(40) – (90)||(117)|
|Cash position beginning of year*||1,516||1,105|
|Cash used in operations||(250) – (300)||(389)|
|Cash from license & share subscription agreement||–||800|
|MN facility sale||50||–|
|Cash position at end of year*||1,266 – 1,316||1,516|
|*Cash, cash equivalents, and marketable securities|
Genmab will hold a conference call in English to discuss the results for the full year 2012 today, Thursday, March 7, at 6:00pm CET, 5:00pm GMT or 12:00pm EST. 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 conference call
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
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®), 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.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: firstname.lastname@example.org
This Company Announcement 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 pre-clinical and clinical development of products, 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 risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a trademark of GlaxoSmithKline.
Company Announcement no. 06
CVR no. 2102 3884
1260 Copenhagen K