August 8, 2018; Copenhagen, Denmark;
Interim Report for the First Half of 2018
Highlights
- USD 943 million in net sales of DARZALEX® (daratumumab), resulting in royalty income of DKK 695 million
- U.S. FDA approved DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for frontline multiple myeloma
- Phase III study of Arzerra® (ofatumumab) plus bendamustine in indolent B-cell non-Hodgkin's lymphoma (iNHL) did not meet primary endpoint
- Phase Ib/II study (CALLISTO/LUC2001) of daratumumab in combination with atezolizumab in non-small cell lung cancer stopped following data monitoring committee review
“We reached a number of key milestones with our clinical development programs during the second quarter including: treating the first patients in the Phase II study of tisotumab vedotin in cervical cancer and in the Phase I/II study of HexaBody®-DR5/DR5 in solid tumors, and advancing the Phase I/II study of HuMax®-AXL-ADC in solid tumors into the expansion phase of the trial. In addition, while we did have disappointing results with daratumumab in lung cancer, this product continues to rapidly progress in the multiple myeloma space, where DARZALEX received another label expansion in the U.S., making it the first antibody ever approved for treatment of frontline multiple myeloma,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2018
- Revenue was DKK 1,191 million in the first half of 2018 compared to DKK 1,024 million in the first half of 2017. The increase of DKK 167 million, or 16%, was mainly driven by the payment from Novartis of USD 50 million and higher DARZALEX royalties, partly offset by a decrease in DARZALEX milestones.
- Operating expenses were DKK 732 million in the first half of 2018 compared to DKK 442 million in the first half of 2017. The increase of DKK 290 million, or 66%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
- Operating income was DKK 459 million in the first half of 2018 compared to DKK 582 million in the first half of 2017. The decrease of DKK 123 million, or 21%, was driven by increased operating expenses, which was partly offset by higher revenue.
Subsequent Events
- July: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX in the European Union. The recommendation is for the use of DARZALEX in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
- July: Genmab entered into a research collaboration and exclusive license agreement with Immatics Biotechnologies GmbH (Immatics) to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. Genmab received an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or T-cell receptor-based bispecific therapeutic product concepts. Genmab may elect to progress any resulting product candidates, and will be responsible for development, manufacturing and worldwide commercialization. For any products that are commercialized by Genmab, Immatics will have an option to limited co-promotion efforts in selected countries in the EU. Under the terms of the agreement, Genmab will pay Immatics an upfront fee of USD 54 million and Immatics is eligible to receive up to USD 550 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2018 today, Wednesday, August 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. To join the call dial
+1 646 828 8193 (US participants) or +44 330 336 9125 (international participants) and provide conference code 6488927.
A live and archived webcast of the call and relevant slides will be available at 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: rcg@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 its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® 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 half of 2018 on attachment or at www.genmab.com.
Company Announcement no. 23
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
