Genmab Announces Financial Results for the First Half of 2021
August 11, 2021; Copenhagen, Denmark;
Interim Report for the First Half of 2021
Highlights
- The U.S. FDA accepted for Priority Review the tisotumab vedotin Biologics License Application (BLA), for patients with recurrent or metastatic cervical cancer
- DARZALEX® net sales increased 52% compared to the first half of 2020 to USD 2,798 million, resulting in royalty income of DKK 2,360 million
- Following a positive CHMP opinion, Janssen-Cilag International NV received European Marketing Authorization for DARZALEX SC (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed light-chain (AL) amyloidosis
- Genmab improves its 2021 financial guidance
“Genmab’s antibody expertise and innovation were on display during the second quarter of 2021 with the U.S. FDA’s acceptance for priority review of the BLA for tisotumab vedotin, which we are developing with Seagen, and with the approval of Janssen’s RYBREVANT™ (amivantamab-vmjw), the first regulatory approval for a product created using Genmab’s proprietary DuoBody® technology platform. The majority of Genmab’s clinical stage products are based on our DuoBody technology, and we hope that the approval of RYBREVANT is just the first validation of many of the potential for this technology to create effective treatments for patients with cancer,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2021
- Net sales of DARZALEX by Janssen Biotech, Inc. (Janssen) were USD 2,798 million in the first half of 2021 compared to USD 1,838 million in the first half of 2020, an increase of USD 960 million, or 52%.
- Royalty revenue was DKK 2,595 million in the first half of 2021 compared to DKK 1,738 million in the first half of 2020, an increase of DKK 857 million, or 49%. The increase was driven by higher net sales of DARZALEX, TEPEZZA® and Kesimpta® resulting in higher royalties.
- Total revenue for the first half of 2021 was DKK 3,553 million. In addition to the royalty revenue described above, Genmab also recognized DKK 731 million of milestone revenue during the first half of 2021. Revenue for the first half of 2020 was DKK 6,343 million and included the one-time upfront payment of DKK 4,398 million recognized as license revenue from AbbVie Inc. (AbbVie) pursuant to our collaboration announced in June 2020.
- Operating expenses were DKK 2,234 million in the first half of 2021 compared to DKK 1,775 million in the first half of 2020. The increase of DKK 459 million, or 26%, 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 broader organizational infrastructure.
- Operating result was DKK 1,319 million in the first half of 2021 compared to DKK 4,568 million in the first half of 2020. The decrease of DKK 3,249 million, or 71%, was driven by lower revenue as a result of the non-recurring license revenue in 2020 and increased operating expenses.
Outlook
Genmab is improving its 2021 financial guidance published on February 23, 2021, driven primarily by increased royalty revenue related to the net sales of DARZALEX.
| Revised | Previous | ||||
| (DKK million) | Guidance | Guidance | |||
| Revenue | 7,300 - 7,900 | 6,800 - 7,500 | |||
| Operating expenses | (5,500) - (5,800) | (5,500) - (5,800) | |||
| Operating result | 1,500 - 2,400 | 1,000 - 2,000 |
Conference Call
Genmab will hold a conference call to discuss the results for the first half of 2021 today, Wednesday, August 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
(U.S. participants) or (international participants) and provide conference code 78377092.
A live and archived webcast of the call and relevant slides will be available at .
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations and Communications
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For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
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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 and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. SEC, which are available at . 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®, UltiMAb® is a trademark of Medarex, Inc., Kesimpta® and Sensoready® are trademarks of Novartis AG or its affiliates. DARZALEX®, DARZALEX FASPRO® and RYBREVANT™ are trademarks of Johnson & Johnson. TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.
Download the full Interim Report for the First Half of 2021 on attachment or at .
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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