November 4, 2020; Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2020
Highlights
- Novartis granted U.S. FDA approval for Kesimpta® (ofatumumab) in relapsing multiple sclerosis
- Janssen and European Myeloma Network achieved positive topline results from Phase 3 APOLLO study of daratumumab in relapsed or refractory multiple myeloma
- Janssen was granted U.S. FDA approval for DARZALEX® (daratumumab) in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma based on Phase 3 CANDOR study
- DARZALEX net sales increased 35% compared to the first nine months of 2019 to USD 2,937 million, resulting in royalty income of DKK 2,898 million for the first nine months of 2020
- Genmab commenced binding arbitration of two matters under daratumumab license agreement with Janssen
·Announcement of plan to transition Arzerra® (ofatumumab) to an oncology access program for chronic lymphocytic leukemia patients in the U.S.
“Genmab continued to deliver on the promise of improving the lives of patients, with multiple regulatory milestones for Genmab-created products under development by our partners, including the exciting U.S. FDA’s approval of Kesimpta and the 8th U.S. FDA approval for DARZALEX,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “During the first nine months of 2020, with our solid financial footing Genmab has continued its focused investment in advancing its proprietary antibody product pipeline and building its capabilities as we evolve into a fully integrated biotech.”
Financial Performance First Nine Months of 2020
- Revenue was DKK 8,067 million in the first nine months of 2020 compared to DKK 2,405 million in the first nine months of 2019. The increase of DKK 5,662 million, or 235%, was primarily driven by the upfront payment from AbbVie pursuant to our new collaboration announced in June and higher DARZALEX royalties.
- Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 2,937 million in the first nine months of 2020 compared to USD 2,168 million in the first nine months of 2019, an increase of USD 769 million, or 35%.
- Operating expenses were DKK 2,641 million in the first nine months of 2020 compared to DKK 1,943 million in the first nine months of 2019. The increase of DKK 698 million, or 36%, was driven by the advancement of epcoritamab (DuoBody®-CD3xCD20) and DuoBody-PD-L1x4-1BB, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
- Operating income was DKK 5,426 million in the first nine months of 2020 compared to DKK 462 million in the first nine months of 2019. The increase of DKK 4,964 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2020 financial guidance published on August 20, 2020.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2020 today, Wednesday, November 4, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call dial
+1 646 741 3167 (U.S. participants) or +44 2071 928338 (international participants) and provide conference code 7839599.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
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 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 or technologies 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 and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
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®, Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.
Download the full Interim Report for the First Nine Months of 2020 on attachment or at www.genmab.com/investors.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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