08 maj: Rapport for 1. kvartal 2019
09 maj: Three-month interim report (Q1) 2019
08-05-2019 17:01:49

Genmab Announces Financial Results for the First Quarter of 2019

May 8, 2019; Copenhagen, Denmark; 

Interim Report for the First Quarter Ended March 31, 2019

Highlights

  • Regulatory applications for daratumumab in combination with lenalidomide and dexamethasone based on the MAIA study in frontline multiple myeloma submitted in U.S. and Europe

  • Regulatory applications for daratumumab in combination with bortezomib, thalidomide and dexamethasone based on the CASSIOPEIA study in frontline multiple myeloma submitted in U.S. and Europe

  • Positive topline results from Phase III COLUMBA study of subcutaneous daratumumab for relapsed or refractory multiple myeloma

  • MorphoSys patent infringement complaint against Genmab and Janssen Biotech, Inc. dismissed, MorphoSys patents ruled invalid for lack of enablement, case ended

  • DARZALEX® net sales increased 46% over Q1 2018 to USD 629 million, resulting in royalty income of DKK 502 million

“The first quarter was filled with regulatory news for DARZALEX, with our collaboration partner Janssen filing multiple new regulatory applications and achieving one new approval.  In addition, we reported positive topline data for subcutaneous daratumumab in relapsed or refractory multiple myeloma,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “During the first quarter we also continued to invest in and advance our innovative proprietary products under development using Genmab’s expertise in antibody drug development to create truly differentiated products to help cancer patients.”

Financial Performance First Quarter of 2019

  • Revenue was DKK 591 million in the first quarter of 2019 compared to DKK 681 million in the first quarter of 2018. The decrease of DKK 90 million, or 13%, was mainly driven by the one-time payment from Novartis of USD 50 million (DKK 304 million) during the first quarter of 2018 for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra® (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets, partly offset by higher DARZALEX royalties and reimbursement income from our collaborations with Seattle Genetics and BioNTech.
  • Operating expenses were DKK 617 million in the first quarter of 2019 compared to DKK 357 million in the first quarter of 2018. The increase of DKK 260 million, or 73%, was driven by the advancement of enapotamab vedotin and tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
  • Operating loss was DKK 26 million in the first quarter of 2019 compared to operating income of DKK 324 million in the first quarter of 2018.  As anticipated, the decrease of DKK 350 million, or 108%, was driven primarily by the one-time payment from Novartis in 2018 and increased operating expenses.

Outlook                                                                                          

Genmab is maintaining its 2019 financial guidance published on February 20, 2019.

Conference Call

Genmab will hold a conference call in English to discuss the results for the first quarter of 2019 today, Wednesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. To join the call dial

+1 631 510 7495 (US participants) or +44 2071 928000 (international participants) and provide conference code 8692103.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:          

Marisol Peron, Corporate Vice President, Communications & Investor Relations

T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:

Andrew Carlsen, Senior Director, Investor Relations

T: +45 3377 9558; E: acn@genmab.com 

The 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 the interim report. Genmab does not undertake any obligation to update or revise forward looking statements in the interim report nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody™; HexElect™; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.

Download the full Interim Report for the First Quarter of 2019 on attachment or at www.genmab.com.

                                                                                                             

 

 

Company Announcement no. 20

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

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