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Genmab Reaches First Milestone in Daratumumab Collaboration With Janssen & Improves 2013 Financial Guidance

Company Announcement

  • Genmab to receive USD 8 million milestone payment from Janssen
  • Milestone triggered by clinical development progress
  • 2013 financial guidance improved

COPENHAGEN, Denmark, Nov. 26, 2013 (GLOBE NEWSWIRE) -- Genmab A/S (Copenhagen:GEN) announced today it has reached the first milestone in its daratumumab collaboration with Janssen Biotech, Inc. ("Janssen"). The milestone was triggered by progress in the clinical development of daratumumab. Genmab will receive a USD 8 million milestone payment from Janssen in connection with this event.

"Since the inception of our agreement with Janssen, we have reported encouraging data from two clinical studies of daratumumab and have started one new study. We are pleased to reach the first milestone in this productive collaboration and look forward to making further progress with daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Outlook

Income Statement Revised Guidance
(MDKK)
Previous Guidance
(MDKK)
Revenue 595 – 635 550 - 590
Operating expenses (600) – (625) (600) – (625)
Operating result continuing operations 35 – (30) (10) – (75)
Discontinued operation 42 42
Cash Position Revised Guidance
(MDKK)
Previous Guidance
(MDKK)
Cash position beginning of year* 1,516 1,516
Cash used in operations (180) – (230) (225) – (275)
MN facility sale 52 52
Warrant exercise 155 155
Cash position at end of year* 1,475 – 1,525 1,430 – 1,480
*Cash, cash equivalents, and marketable securities

Genmab is improving its 2013 financial guidance as published on August 14, 2013 and as amended on November 13, 2013 due to proceeds from warrant exercises.

Continuing Operations

Due the achievement of the USD 8 million daratumumab milestone, approximately DKK 44 million, we are improving the revenue guidance, which is now expected to be in the range of DKK 595 – 635 million compared to DKK 550 – 590 million in the previous guidance.

There is no change to the operating expense guidance, which remains at DKK 600 – 625 million.

As a result of the improved revenue, we now project an operating result between an operating income of DKK 35 million and an operating loss of DKK 30 million.

Cash Position

As of December 31, 2012, we had a cash position of DKK 1,516 million and now, with the inclusion of the daratumumab milestone, we are projecting a cash burn from operations in 2013 of DKK 180 - 230 million, an improvement from the previous guidance of DKK 225 – 275 million. With the proceeds from warrant exercises we are now projecting an improved cash position at the end of 2013, including the facility sale at DKK 52 million, of DKK 1,475 – 1,525 million. This compares with the previous guidance of DKK 1,430 – 1,480 million.

The estimates above are subject to change for numerous reasons, including but not limited to, the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; achievement of certain milestones associated with our collaboration agreements; Arzerra sales and corresponding royalties to Genmab; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance also assumes that no significant agreements are entered into during 2013 that could materially affect the results.

About daratumumab

Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.

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.

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 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®; Genmab in combination with the Y-shaped Genmab logoTM; the DuoBody™ logo; HuMax®; HuMax-CD20®; DuoBody®, HexaBodyTM and UniBody®. Arzerra® is a registered trademark of GlaxoSmithKline.

Company Announcement no. 49
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

Attachments:

49 Daratumumab milestone_uk_261113.pdf

Source: Genmab A/S