On February 16, 2022 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2021 (Press release, Genmab, FEB 16, 2022, View Source [SID1234608179]). Below is a summary of business progress in 2021, financial performance for the year and the financial outlook for 2022 . The full report is attached as a PDF file 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 2021 today, February 16, 2022 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 76485840.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
2021 ACHIEVEMENTS
Business Progress
Bring our own medicines to patients
Tisotumab vedotin1 — U.S. FDA decision on BLA and progress to market — achieved
Tisotumab vedotin — Japanese New Drug Application (JNDA) submission in cervical cancer — potential JNDA filing timeline postponed to include Phase 3 innovaTV 301 data
Epcoritamab2 — acceleration & maximization of development program by advancing expansion cohorts and initiating additional Phase 3 trials — partial criteria was met for this goal in 2021, further progress is anticipated in 2022
Build world-class differentiated product pipeline
DuoBody-PD-L1x4-1BB3 — expansion cohort data — achieved
DuoBody-CD40x4-1BB3 — dose escalation data — achieved
Tisotumab vedotin — data in other tumor indication — achieved
Earlier stage products — progress & expand innovative product pipeline — partial criteria was met for this goal in 2021, further progress is anticipated in 2022
Become leading integrated innovation powerhouse
Operational commercialization model in US & Japan — achieved
Further strengthen solid financial foundation — achieved
Financial Performance
Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 6,023 million in 2021 compared to USD 4,190 million in 2020, an increase of USD 1,833 million, or 44%.
Royalty revenue was DKK 6,977 million in 2021 compared to DKK 4,741 million in 2020, an increase of DKK 2,236 million, or 47%. The increase was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta resulting in higher royalties.
Total revenue was DKK 8,482 million in 2021. In addition to the royalty revenue described above, Genmab also recognized DKK 954 million of milestone revenue during 2021. Revenue in 2020 was DKK 10,111 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 5,464 million in 2021 compared to DKK 3,798 million in 2020. The increase of DKK 1,666 million, or 44%, was driven by the continued advancement of multiple pipeline projects, the increase in new team members to support the launch of Tivdak and expansion of our product pipeline, as well as the continued development of commercialization capabilities and Genmab’s broader organizational infrastructure.
Operating profit was DKK 3,018 million in 2021 compared to DKK 6,313 million in 2020. The decrease of DKK 3,295 million, or 52%, was driven by lower revenue as a result of the non-recurring license revenue in 2020 associated with the upfront payment from AbbVie and increased operating expenses.
Revenue
Genmab expects its 2022 revenue to be in the range of DKK 10,800 – 12,000 million, compared to DKK 8,482 million in 2021. Our revenue in 2021 was driven primarily by the continued strong growth of DARZALEX net sales.
Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties of DKK 7,700 – 8,500 million. Such royalties are based on estimated DARZALEX 2022 net sales of USD 7.3 – 8.0 billion compared to actual net sales in 2021 of approximately USD 6.0 billion. Since the second quarter of 2020, Janssen has reduced its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. in connection with subcutaneous sales. Given the ongoing arbitration, Genmab has reflected this as a reduction to estimated 2022 revenue. The remainder of Genmab’s revenue consists of increasing royalties from TEPEZZA, Kesimpta and RYBREVANT, reimbursement revenue, milestones for epcoritamab, other milestones and collaboration revenue related to Tivdak commercialization efforts in the U.S. as part of our Seagen Inc. (Seagen) collaboration.
Operating Expenses
Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,200 – 7,800 million, compared to DKK 5,464 million in 2021. The increase is driven by the advancement of Genmab’s clinical programs, continued investment in research and development, as well as building Genmab’s commercial organization and broader organizational infrastructure.
Operating Profit
We expect our operating profit to be in the range of DKK 3,000 – 4,800 million in 2022, compared to DKK 3,018 million in 2021.
More information on the Risks and Assumptions for the 2022 Financial Guidance can be found in the 2021 Annual Report available on our website www.genmab.com/investors.