On February 24, 2024 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2023 (Press release, Genmab, FEB 14, 2024, View Source [SID1234640090]). Below is a summary of business progress in 2023, financial performance for the year and the financial outlook for 2024. The full report is attached as a PDF file and in iXBRL format and can be found in the investor section of the company’s website, www.genmab.com/investors.

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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2023 today, February 14, 2024 at 6:00 pm CET, 5:00 pm GMT, 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/BId9317ea1b2844573b09971b162f4d87b.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

2023 ACHIEVEMENTS

Business Progress

Multiple regulatory approvals granted to Genmab and AbbVie for EPKINLY/TEPKINLY.
Successful launch of EPKINLY (epcoritamab-bysp) in the U.S. and Japan, a first in Genmab’s history.
Regulatory submissions based on positive topline results from the follicular lymphoma (FL) cohort of the pivotal EPCORE NHL-1 epcoritamab study.
Genmab and Pfizer Inc.1 initiate discussions with regulatory authorities based on positive topline results from the innovaTV 301 and innovaTV 207 tisotumab vedotin studies.
Decision on moving to late-stage development for acasunlimab (GEN1046/BNT311).
Multiple Investigational New Drug (IND) submissions.
Entered into collaboration with argenx to jointly discover, develop and commercialize therapeutic antibodies with applications in immunology and oncology.
Continued development of Genmab’s broader organizational infrastructure with the addition of over 500 new colleagues.
Grand opening of new headquarters in Copenhagen, Denmark, and expansion of Genmab Research and Development Center (GRDC) with the Accelerator in Utrecht, the Netherlands.
Janssen’s TALVEY becomes 8th approved medicine applying Genmab innovation.
Financial Performance

Net sales of DARZALEX by Janssen were USD 9,744 million in 2023 compared to USD 7,977 million in 2022. The increase of USD 1,767 million, or 22%, was driven by share gains in all regions.
EPKINLY delivered USD 64 million for FY2023 with two full quarters of sales. USD 55 million were from the US market.
Royalty revenue amounted to DKK 13,705 million in 2023 compared to DKK 11,582 million in 2022. The increase of DKK 2,123 million, or 18%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our daratumumab collaboration with Janssen and ofatumumab collaboration with Novartis, respectively, partly offset by negative foreign exchange rate impacts due to a lower average exchange rate between the USD and DKK.
Genmab’s revenue was DKK 16,474 million in 2023 compared to DKK 14,505 million in 2022. The increase of DKK 1,969 million, or 14%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis, respectively, partly offset by milestones achieved in 2022 under our collaboration with AbbVie. EPKINLY net product sales, driven by a strong product launch, also contributed to increased revenue in 2023.
Genmab’s operating expenses increased by DKK 2,689 million, or 33%, from DKK 8,238 million in 2022 to DKK 10,927 million in 2023, driven by the increase and accelerated advancement of epcoritamab under our collaboration with AbbVie, advancement of acasunlimab and DuoBody-CD40x4-1BB under our collaboration with BioNTech, further progression of pipeline products, EPKINLY launch in the U.S. and Japan, the continued development of Genmab’s broader organizational capabilities, and related increase in team members to support these activities.
Operating profit was DKK 5,321 million in 2023.
2024 OUTLOOK

(DKK millions) 2023 Actual Result 2024 Guidance 2024 Guidance Mid-Point 2023 Growth % 2024 Growth %*
Revenue 16,474 18,700 – 20,500 19,600 14% 19%
Royalties 13,705 15,600 – 16,700 16,150 18% 18%
Net product sales/Collaboration revenue** 728 1,700 – 2,200 1,950 231% 168%
Milestones/Reimbursement revenue 2,041 1,400 – 1,600 1,500 -24% -27%
Gross profit 16,248 18,000 – 19,500 18,750 12% 15%
Operating expenses (10,927) (12,400) – (13,400) (12,900) 33% 18%
Operating profit 5,321 4,600 – 7,100 5,850 -15% 10%
*Mid-point of guidance range
**Net product sales and collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak (Genmab’s share of gross profits) in the U.S. Collaboration revenue excludes one-off payment in 2022 from Pfizer of approximately USD 15 million (DKK 112 million) related to the sublicense of rights to develop and commercialize tisotumab vedotin in China to Zai Lab Hong Kong. This amount is included in Milestone/Reimbursement revenue for this presentation.

Revenue
Genmab expects its 2024 revenue to be in the range of DKK 18.7 – 20.5 billion, compared to DKK 16.5 billion in 2023. Our revenue in 2023 was driven primarily by DARZALEX (daratumumab) royalties due to the continued strong growth of DARZALEX net sales partially offset by negative exchange rate movements between the USD and DKK and negative impact of applying the DARZALEX contractual annual Currency Hedge Rate.

Genmab’s projected revenue growth for 2024 is driven by higher royalties, net product sales and collaboration revenue. Royalty growth relates mainly to DARZALEX and Kesimpta (ofatumumab) net sales growth. Net product sales and collaboration revenue growth driven by strong performance for both Tivdak and EPKINLY. Net product sales and collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak (50% gross profit share) in the U.S.

Genmab’s projected revenue for 2024 primarily consists of DARZALEX royalties of DKK 12.6 – 13.3 billion. Such royalties are based on estimated DARZALEX 2024 net sales of USD 10.9 – 11.5 billion compared to actual net sales in 2023 of approximately USD 9.7 billion. DARZALEX royalties are partly offset by Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with subcutaneous (SC) net sales as well as royalty reduction in countries and territories where there are no Genmab patents. The remainder of Genmab’s revenue consists of royalties from Kesimpta, TEPEZZA, RYBREVANT, TECVAYLI, TALVEY and TEPKINLY, net product sales and collaboration revenue from EPKINLY and Tivdak, reimbursement revenue and milestones.

Operating Expenses
Genmab anticipates its 2024 operating expenses to be in the range of DKK 12.4 – 13.4 billion, compared to DKK 10.9 billion in 2023. The growth in operating expenses is to support Genmab’s continued portfolio advancement and investing for future product launches, including epcoritamab.

Operating Profit
Genmab expects its operating profit to be in the range of DKK 4.6 – 7.1 billion in 2024, compared to DKK 5.3 billion in 2023.

More information on the Risks and Assumptions for the 2024 Financial Guidance can be found in the 2023 Annual Report available on our website www.genmab.com/investors.

Share Buy-back Program

Repurchase of up to 190,000 shares to honor our commitments under our Restricted Stock Unit Program.
At the Annual General Meeting on March 13, 2024, the Board of Directors will propose the Annual General Meeting authorizes the Board of Directors to allow the Company to initiate a new share buyback program of up to DKK 3.5 billion.