Company Announcement
COPENHAGEN, Denmark; February 22, 2023 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2022. Below is a summary of business progress in 2022, financial performance for the year and the financial outlook for 2023. 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.
Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2022 today, February 22, 2023 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/BI4ae0b28086fa4647832458429ebd9645.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
2022 ACHIEVEMENTS
Business Progress
- The U.S. Food and Drug Administration (U.S. FDA) granted orphan-drug designation to epcoritamab for the treatment of follicular lymphoma.
- The publication by Genmab and collaboration partner AbbVie Inc. (AbbVie) of topline results from the large B-cell lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 epcoritamab study.
- Regulatory submissions for subcutaneous (SC) epcoritamab were made in the U.S. and Japan by Genmab and in Europe by AbbVie.
- The Biologics License Application for SC epcoritamab for the treatment of patients with relapsed/refractory LBCL after two or more lines of systemic therapy was accepted for Priority Review by the U.S. FDA with a Prescription Drug User Fee Act target action date of May 21, 2023.
- The Marketing Authorization Application for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy was validated by the European Medicines Agency.
- 2022 was the first full year of Tivdak® (tisotumab vedotin-tftv), in co-development with Seagen Inc., available for certain cervical cancer patients in the U.S.
- We continued the development of our commercialization capabilities and broader organizational infrastructure.
- We expanded our global strategic collaboration with BioNTech SE, including investigational medicine HexaBody®-CD27 (GEN1053/BNT313).
- Janssen Biotech Inc. (Janssen)’s TECVAYLI® (teclistamab) became the second DuoBody®-based medicine to receive regulatory approval.
Financial Performance
- Net sales of DARZALEX® by Janssen were USD 7,977 million in 2022 compared to USD 6,023 million in 2021, an increase of USD 1,954 million, or 32%.
- Royalty revenue was DKK 11,672 million in 2022 compared to DKK 6,977 million in 2021, an increase of DKK 4,695 million, or 67%. The increase in royalties was driven by higher net sales of DARZALEX, Kesimpta® and TEPEZZA® and higher average exchange rate between the USD and DKK.
- Revenue was DKK 14,595 million in 2022 compared to DKK 8,482 million in 2021. The increase of DKK 6,113 million, or 72%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis, respectively, due to higher net sales and higher average exchange rate between the USD and DKK, and milestones achieved in 2022 under our collaboration with AbbVie.
- Operating expenses were DKK 8,238 million in 2022 compared to DKK 5,464 million in 2021. The increase of DKK 2,774 million, or 51%, 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 6,357 million in 2022 compared to DKK 3,018 million in 2021.
2023 OUTLOOK
| (DKK million) | 2023 Guidance | 2022 Actual Result |
| Revenue | 14,600 - 16,100 | 14,595 |
| Operating expenses | (9,800) - (10,600) | (8,238) |
| Operating profit | 3,900 - 6,200* | 6,357 |
*Operating profit does not sum due to rounding
Revenue
Genmab expects its 2023 revenue to be in the range of DKK 14,600 – 16,100 million, compared to DKK 14,595 million in 2022. Our revenue in 2022 was driven primarily by DARZALEX royalties due to the continued strong growth of DARZALEX net sales, favorable exchange rate movements between the USD and DKK and the positive impact of applying the DARZALEX contractual annual Currency Hedge Rate.
Genmab’s projected revenue growth for 2023 is driven by recurring revenues related to DARZALEX, TEPEZZA and Kesimpta royalties from net sales growth, partly offset by negative exchange rate movements between the USD and DKK due to a lower assumed USD/DKK exchange rate.
Genmab’s projected revenue for 2023 primarily consists of DARZALEX royalties of DKK 10,400 – 11,100 million. Such royalties are based on estimated DARZALEX 2023 net sales of USD 9.4 – 10.0 billion compared to actual net sales in 2022 of approximately USD 8.0 billion. DARZALEX royalties are partly offset by Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with SC net sales. The remainder of Genmab’s revenue consists of increasing royalties from TEPEZZA, Kesimpta, RYBREVANT and TECVAYLI, reimbursement revenue, milestones including those for epcoritamab and collaboration revenue with Seagen for Tivdak.
Operating Expenses
Genmab anticipates its 2023 operating expenses to be in the range of DKK 9,800 – 10,600 million, compared to DKK 8,238 million in 2022. 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 our operating profit to be in the range of DKK 3,900 – 6,200 million in 2023, compared to DKK 6,357 million in 2022.
More information on the Risks and Assumptions for the 2023 Financial Guidance can be found in the 2022 Annual Report available on our website www.genmab.com /investors.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.
Contact:
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
TheAnnual Reportcontains 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 productsor technologiesobsolete, 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 onwww.genmab.comand the risk factors included in Genmab’smost recent Annual Report on Form 20-Fand other filingswith the U.S. Securities and Exchange Commission (SEC), which are available atwww.sec.gov.Genmab does not undertake any obligation to update or revise forward looking statements inthe Annual Reportnor to confirm such statementsto reflect subsequent events or circumstances after the date made orin 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 withthe HexaBody logo®; DuoHexaBody®andHexElect®.Tivdak®is a trademark of Seagen Inc.; Kesimpta®is atrademark of Novartis AG or its affiliates; DARZALEX®, RYBREVANT®, and TECVAYLI®are trademarks of Johnson & Johnson; EPCORE™ is a trademark of AbbVie Biotechnology Ltd.; TEPEZZA®is a trademark of Horizon Therapeutics Ireland DAC.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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