Latest News by Industry
November 9, 2022 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2022
Highlights
“During the first nine months of the year we continued to build on Genmab’s consistent track record of success. We have strengthened our pipeline, our team and our financial foundation is even more robust. We are pleased with the recent U.S. and European regulatory submissions for epcoritamab. These submissions are an important step in potentially bringing epcoritamab to people living with certain hematologic malignancies who are in need of a new treatment option,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2022
Epcoritamab Regulatory Update
There were two regulatory submissions for epcoritamab in the second half of 2022. Genmab submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (U.S. FDA) for subcutaneous (SC) epcoritamab for the treatment of patients with relapsed/refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Additionally, AbbVie submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for SC epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, which has been validated by the EMA. Both submissions were supported by results from the LBCL cohort of the pivotal EPCORE™ NHL-1 open-label, multi-center trial evaluating the safety and preliminary efficacy of epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL.
Outlook
As announced in Company Announcement No. 54, Genmab is improving its 2022 financial guidance published on August 8, 2022, driven primarily by the positive foreign exchange rate impact on our royalty revenue, and the continued strong performance of DARZALEX net sales.
| Revised | Previous | ||||
| (DKK million) | Guidance | Guidance | |||
| Revenue | 13,500 - 14,500 | 12,000 - 13,000 | |||
| Operating expenses | (8,000) - (8,400) | (7,600) - (8,200) | |||
| Operating profit | 5,100 - 6,500 | 3,800 - 5,400 |
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2022 today, Wednesday, November 9, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BI2f752c494cf441f8b2fd8379c5219dc7. 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, Communications and Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
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 onwww.genmab.comand 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 atwww.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.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with theY-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; and HexElect®.Tivdak®is a trademark of Seagen Inc.;EPCORE™ is a trademark of AbbVie Biotechnology Ltd.;Kesimpta®and Sensoready®are trademarks of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®RYBREVANT®and TECVAYLI®are trademarks of Johnson & Johnson; TEPEZZA®is a trademark of Horizon Therapeutics Ireland DAC.
Download the full Interim Report for the First Nine Months of 2022 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
Attachment