November 9, 2022 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2022
- Genmab revenue increased 60% compared to the first nine months of 2021, to DKK 9,368 million
- Genmab improves its 2022 financial guidance
“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
- Net sales of DARZALEX® by Janssen Biotech, Inc. (Janssen) were USD 5,894 million in the first nine months of 2022 compared to USD 4,378 million in the first nine months of 2021, an increase of USD 1,516 million, or 35%.
- Royalty revenue was DKK 8,207 million in the first nine months of 2022 compared to DKK 4,698 million in the first nine months of 2021, an increase of DKK 3,509 million, or 75%. The increase in royalties was driven by higher net sales of DARZALEX, Kesimpta® and TEPEZZA® and a higher average exchange rate between the USD and DKK.
- Revenue was DKK 9,368 million for the first nine months of 2022 compared to DKK 5,863 million for the first nine months of 2021. The increase of DKK 3,505 million, or 60%, was primarily driven by higher DARZALEX, Kesimpta and TEPEZZA royalties achieved under our collaborations with Janssen, Novartis Pharma AG (Novartis) and Roche, respectively, an increase in Tivdak® collaboration revenue, and reimbursement revenue driven by higher activities under our collaboration agreements with BioNTech SE (BioNTech), partly offset by milestones achieved under our collaborations with Janssen and AbbVie in the first nine months of 2021.
- Operating expenses were DKK 5,676 million in the first nine months of 2022 compared to DKK 3,654 million in the first nine months of 2021. The increase of DKK 2,022 million, or 55%, was driven by the continued advancement of epcoritamab and multiple pipeline projects, an increase in team members to support Tivdak post launch and expansion of our product pipeline, and the continued development of Genmab’s commercialization and broader organizational capabilities and infrastructure.
- Operating profit was DKK 3,692 million in the first nine months of 2022 compared to DKK 2,209 million in the first nine months of 2021.
- Net financial items was income of DKK 2,681 million for the first nine months of 2022 compared to income of DKK 808 million in the first nine months of 2021. The increase of DKK 1,873 million was primarily driven by net foreign exchange rate gains due to the USD strengthening against the DKK.
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.
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.
|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|
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.
Marisol Peron, Senior Vice President, Communications and Corporate Affairs
T: +1 609 524 0065; E: email@example.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: firstname.lastname@example.org
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.
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®; 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.
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