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Genmab announces financial results for the first half of 2024


Genmab announces financial results for the first half of 2024

Genmab A/SGenmab A/S

Genmab A/S

August 8, 2024 Copenhagen, Denmark;
Interim report for the first six months to 30 June 2024

Highlights

  • Completed acquisition of ProfoundBio Inc (ProfoundBio), giving Genmab worldwide rights to three candidates in clinical development, including Rinatabart Sesutecan (Rina-S), as well as ProfoundBio’s novel antibody-drug conjugate technology platforms

  • The US Food and Drug Administration (FDA) has approved EPKINLY® (Epcoritamab-bysp) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy

  • The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion and recommended the granting of a conditional marketing authorisation for TEPKINLY.® (Epcoritamab) for the treatment of adult patients with relapsed or refractory FL after two or more lines of systemic therapy

  • Tivdak® (Tisotumab Vedotin-Tftv) received full US FDA approval for the treatment of recurrent or metastatic cervical cancer

  • Genmab has submitted a marketing authorization application for Tivdak (tisotumab vedotin) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of adult patients with advanced or recurrent cervical cancer that has progressed during or after chemotherapy.

  • Genmab’s sales increased by 36% to DKK 9,545 million compared to the first six months of 2023

  • Genmab 2024 financial forecast updated

“In the second quarter of 2024, we achieved a number of important milestones for the company. The acquisition of ProfoundBio as well as the regulatory approvals for EPKINLY and Tivdak underscore our commitment to developing differentiated antibody therapies and bring Genmab closer to our ambitious 2030 vision of changing patients’ lives with our innovative antibody medicines,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial development in the first half of 2024

  • Sales amounted to DKK 9,545 million in the first six months of 2024 compared to DKK 7,003 million in the first six months of 2023. The increase of DKK 2,542 million or 36% was primarily due to higher DARZALEX® (Daratumumab) and Kesimpta® (Ofatumumab) royalties generated from our collaborations with Janssen Biotech, Inc. (Janssen) and Novartis Pharma AG (Novartis), respectively, and increased EPKINLY’s net product sales.

  • Royalty income for the first six months of 2024 was DKK 7,673 million compared to DKK 5,886 million for the first six months of 2023, an increase of DKK 1,787 million or 30%. The increase in royalty income was due to higher net sales of DARZALEX and Kesimpta.

  • Net sales of DARZALEX, including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the trade name DARZALEX FASPRO® Janssen’s revenues (including sales in the United States) were $5,570 million for the first six months of 2024 compared to $4,695 million for the first six months of 2023, an increase of $875 million, or 19%.

  • Total costs and operating expenses amounted to DKK 7,104 million in the first six months of 2024 compared to DKK 5,118 million in the first six months of 2023. The increase of DKK 1,986 million or 39% is due to the expansion of our product pipeline, post-launch activities of EPKINLY in the US and Japan, the continued development of Genmab’s broader organizational capabilities and the related increase in team members to support these activities, as well as profit sharing amounts payable to AbbVie Inc. (AbbVie) in connection with the EPKINLY sales.

  • Operating profit was DKK 2,441 million in the first six months of 2024, compared to DKK 1,885 million in the first six months of 2023.

  • Net financial item resulted in income of DKK 1,402 million in the first six months of 2024 compared to DKK 75 million in the first six months of 2023. The increase of DKK 1,327 million was mainly due to exchange rate fluctuations between USD and DKK affecting Genmab’s USD-denominated cash and cash equivalents and marketable securities, with the USD/DKK rate increasing in the first six months of 2024 while weakening in the first six months of 2023.

Important event after the end of the quarter

  • August: Genmab announced that it will assume sole responsibility for the continued development and potential commercialization of acasunlimab. BioNTech SE (BioNTech) has elected not to participate in the further development of the acasunlimab program under the parties’ existing collaboration agreement. The program is subject to the payment of certain milestones and a tiered single-digit royalty on Genmab’s net sales to BioNTech. Although the emerging clinical profile of acasunlimab is encouraging, BioNTech informed the company that it made this decision for reasons related to its portfolio strategy. The companies’ long-standing collaboration in antibody research remains intact, and both parties will continue to advance the existing programs under their existing agreements, which were expanded in 2022.

outlook
As announced in Company Announcement No. 52, Genmab updates its 2024 financial guidance.

Revised

Revised

Orientation aid

Orientation aid

(DKK million)

excl. takeover and integration costs

including acquisition and integration costs

Previous instructions

revenue

20,500 – 21,700

20,500 – 21,700

18,700 – 20,500

License fees

16,600 – 17,400

16,600 – 17,400

15,600 – 16,700

Net product sales/cooperation sales*

2,000 – 2,200

2,000 – 2,200

1,700 – 2,200

Milestones/Reimbursement Proceeds

1,900 – 2,100

1,900 – 2,100

1,400 – 1,600

Gross profit**

19,600 – 20,800

19,600 – 20,800

18,000 – 19,500

Operating expenses**

(13,700) – (14,300)

(14,100) – (14,700)

(12,400) – (13,400)

Operating result

5,300 – 7,100

4,900 – 6,700

4,600 – 7,100

*Net revenue from product sales and collaborations consists of net revenue from EPKINLY in the US and Japan and Tivdak (Genmab’s share of net profit) in the US.
**The operating expenses area excludes the cost area of ​​the product sales area, which is included in the gross profit area

telephone conference
Genmab will hold a conference call today, August 8, 2024, at 6:00 p.m. CEST, 5:00 p.m. BST or 12:00 p.m. EDT to discuss its first half 2024 results. To join the call, please use the registration link below. 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/BI61134ed097674233a89964e3bc06a69e. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.

Contact
Marisol Peron, Senior Vice President, Global Communications and Corporate Affairs
T: +1 609 524 0065; E: [email protected]

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: [email protected]

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. Important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties associated with the outcome and conduct of clinical trials, including unforeseen safety issues, uncertainties associated with product manufacturing, lack of market acceptance of our products, our inability to manage growth, the competitive environment related to our business and markets, our inability to attract and retain appropriately qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliates, changes and developments in technology that may render our products or technologies obsolete, and other factors. For a further discussion of these risks, see the risk management sections in Genmab’s most recent financial reports, which are available at www.genmab.com and the risk factors contained in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), available at www.sec.govGenmab undertakes no obligation to update or revise any forward-looking statements in the interim report or to confirm such statements to reflect subsequent events or circumstances after the date hereof or to reflect actual results, except as 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®; HexaBody®; DuoHexaBody®; HexElect® and KYSO®; Tivdak® is a trademark of Seagen Inc.; EPCORE™, EPKINLY®TEPKINLY® and their designs are trademarks of AbbVie Biotechnology Ltd.; Kesimpta® and sensor ready® are trademarks of Novartis AG or its subsidiaries; DARZALEX®DARZALEX FASPRO®RYBREVANT®TECVAYLI® and TALVEY® are trademarks of Johnson & Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.

Download the full interim report for the first half of 2024 in the appendix or at www.genmab.com/investor-relations.

CVR No.: 2102 3884
LEI code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsen’s Road 30
2500 Valby
Denmark

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