Genmab Interim Report for the First Quarter Ended March 31,2021
May 5, 2021; Copenhagen, Denmark;
Genmab A/S, Interim Report for the First Quarter Ended March31,2021
Highlights
- Genmab and Seagen Inc.submittedtisotumab vedotin Biologics License Application (BLA) to the U.S. FDA for patients with recurrent or metastatic cervical cancer
- First patient dosed in Phase 3 epcoritamab study triggersUSD 40 million milestone in collaboration with AbbVie Inc.
- DARZALEX® net sales increased 46% compared to the first quarter of 2020 to USD 1,365 million, resulting in royalty income of DKK 984 million
- Janssen Biotech, Inc. granted U.S. FDA approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for patients with newly diagnosed light-chain (AL) amyloidosis
- Novartis received a positive CHMP opinion, followed by approval in Europe, for Kesimpta® (ofatumumab) in the treatment of relapsing forms of multiple sclerosisin adults with active disease defined by clinical or imaging features
- Tahamtan Ahmadi appointed Executive Vice President and Chief Medical Officer, Head of Experimental Medicines
“In 2020, Genmab reached an inflection point in our evolution into a fully integrated biotech innovation powerhouse. This momentum has continued into the first quarter of 2021, with the BLA submission for tisotumab vedotin, our product in development with Seagen. If approved by the U.S. FDA, we believe that tisotumab vedotin as monotherapy has the potential to become an important treatment option for women with recurrent or metastatic cervical cancer, who have disease progression on or after chemotherapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter of 2021
- Revenue was DKK 1,581 million in the first quarter of 2021 compared to DKK 892 million in the first quarter of 2020. The increase of DKK 689 million, or 77%, was primarily driven by higher DARZALEX royalties and milestones related to epcoritamab and DARZALEX FASPRO.
- Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 1,365 million in the first quarter of 2021 compared to USD 937 million in the first quarter of 2020, an increase of USD 428 million, or 46%.
- Operating expenses were DKK 1,049 million in the first quarter of 2021 compared to DKK 821 million in the first quarter of 2020. The increase of DKK 228 million, or 28%, was driven by the continued advancement of multiple pipeline projects, and the increase in new employees to support the expansion of our product pipeline and building our commercialization capabilities and infrastructure.
- Operating result was DKK 532 million in the first quarter of 2021 compared to DKK 71 million in the first quarter of 2020. The increase of DKK 461 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2021 financial guidance published on February 23, 2021.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2021 today, Wednesday, May 5, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 29164332.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations and Communications
T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
TheInterim 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 theInterim 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®; and HexElect®. Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Johnson & Johnson. TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.
Download the full Interim Report for the First Quarter of 2021 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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