Company Announcement
Copenhagen, Denmark; February 23, 2021 –
Genmab A/S (Nasdaq: GMAB) announced today the publication
of its Annual Report for 2020. Below is a summary of
business progress in 2020, financial performance for the year and
the financial outlook for 2021. The full report is attached as a
PDF file and can be found on the investor section of the company’s
website, www.genmab.com/investors.
Conference CallGenmab will hold a conference
call in English to discuss the full year results for 2020 today,
February 23, 2021 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
82034909.
A live and archived webcast of the call and relevant slides will
be available at www.genmab.com/investors.
2020 ACHIEVEMENTS Business
Progress Genmab Proprietary Products
- Tisotumab vedotin1 - Phase 2 innovaTV 204 safety & efficacy
analysis in recurrent/metastatic cervical cancer and engage U.S.
FDA for BLA submission subject to trial results - achieved
- Tisotumab vedotin - data on other solid tumor types –
anticipated in 2021
- Enapotamab vedotin – data to support late stage development –
development will not advance
- Epcoritamab (DuoBody-CD3xCD20)2 Phase 1/2 – decision on
recommended Phase 2 dose & initiate expansion cohorts -
achieved
- HexaBody-DR5/DR5 Phase 1/2 - advance dose escalation -
anticipated in 2021
- DuoBody-PD-L1x4-1BB3 Phase 1/2 – initiate expansion cohorts -
achieved
- DuoBody-PD-L1x4-1BB initial data in H2 2020 - achieved
- File INDs and/or CTAs for 2 new products - achieved
Daratumumab4
- U.S. FDA and EMA decision on Phase 3 COLUMBA multiple myeloma
SubQ submission - achieved
- sBLA and MAA Submission Phase 3 ANDROMEDA amyloidosis -
achieved
- sBLA and MAA submission Phase 3 APOLLO multiple myeloma -
achieved
Ofatumumab5 ·U.S. FDA
decision on regulatory dossier submission in multiple sclerosis –
achieved
Teprotumumab6 ·U.S. FDA
decision on Phase 3 OPTIC active thyroid eye disease submission –
achieved
Broad Oncology Collaboration with AbbVie·A broad, long-term
oncology collaboration with Genmab and AbbVie working together to
jointly develop and commercialize epcoritamab, DuoHexaBody-CD37 and
DuoBody-CD3x5T4 and a discovery research collaboration for future
differentiated antibody therapeutics for cancer
Financial Performance
- Revenue was DKK 10,111 million in 2020 compared to DKK 5,366
million in 2019. The increase of DKK 4,745 million, or 88%, was
primarily driven by the upfront payment from AbbVie pursuant to our
new collaboration announced in June and higher DARZALEX®
royalties.
- Operating expenses increased by DKK 1,070 million, or 39%, from
DKK 2,728 million in 2019 to DKK 3,798 million in 2020 driven by
the advancement of epcoritamab (DuoBody-CD3xCD20) and
DuoBody-PD-L1x4-1BB, additional investments in our product pipeline
and the increase in new employees to support the expansion of our
product pipeline.
- Operating result was DKK 6,313 million in 2020 compared to DKK
2,638 million in 2019. The improvement of DKK 3,675 million, or
139%, was driven by higher revenue, which was partly offset by
increased operating expenses.
- 2020 year-end cash position of DKK 16,079 million, an increase
of DKK 5,108 million, or 47%, from DKK 10,971 million as of
December 31, 2019.
2021 OUTLOOK
(DKK million) |
2021 Guidance |
2020 Actual Result |
Revenue |
6,800 - 7,500 |
10,111 |
Operating expenses |
(5,500) - (5,800) |
(3,798) |
Operating result |
1,000 - 2,000 |
6,313 |
Revenue We expect our 2021 revenue to be in the
range of DKK 6,800 – 7,500 million, compared to DKK 10,111 million
in 2020. Our revenue in 2020 was significantly impacted by the
AbbVie collaboration and included DKK 4,398 million related to the
portion of the upfront payment that was allocated to the license
grants and recognized as revenue in 2020.
Our projected revenue for 2021 primarily consists of DARZALEX®
royalties of DKK 4,900 – 5,300 million. Such royalties are based on
estimated DARZALEX® 2021 net sales of USD 5.2 – 5.6 billion
compared to actual net sales in 2020 of approximately USD 4.2
billion. Janssen has started reducing its royalty payments to
Genmab by what it claims to be Genmab’s share of Janssen’s royalty
payments to Halozyme in connection with subcutaneous sales
beginning in the second quarter of 2020. Given the ongoing
arbitration, Genmab has reflected this as a reduction to estimated
2021 revenue. The remainder of our revenue consists of royalties
from TEPEZZA® and Kesimpta®, reimbursement revenue, milestones for
epcoritamab under our AbbVie collaboration, and other
milestones.
Operating Expenses We anticipate our 2021
operating expenses to be in the range of DKK 5,500 – 5,800 million,
compared to DKK 3,798 million in 2020. The increase is driven by
the advancement of our clinical programs, continued investment in
research and development, as well as building our commercial
organization and infrastructure.
Operating Result We expect our operating result
to be in the range of DKK 1,000 – 2,000 million in 2021, compared
to DKK 6,313 million in 2020.
More information on the Risks and Assumptions for the 2021
Financial Guidance can be found in the 2020 Annual Report available
on our website www.genmab.com/investors.
About Genmab Genmab is an international
biotechnology company with a core purpose to improve the lives of
patients with cancer. Founded in 1999, Genmab is the creator of
multiple approved antibody therapeutics that are marketed by its
partners. The company aims to create, develop and commercialize
differentiated therapies by leveraging next-generation antibody
technologies, expertise in antibody biology, translational research
and data sciences and strategic partnerships. To create novel
therapies, Genmab utilizes its next-generation antibody
technologies, which are the result of its collaborative company
culture and a deep passion for innovation. Genmab’s proprietary
pipeline consists of modified antibody candidates, including
bispecific T-cell engagers and next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates. The company 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.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations and
CommunicationsT: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior Director, Head of
Investor Relations T: +45 3377 9558; E: acn@genmab.com
The annual 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
product discovery and development, 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 obsolete, and other factors. For a further discussion
of these risks, please refer to the section “Risk Management” in
the annual report and the risk factors included in Genmab’s most
recent Annual Report on Form 20-F and other filings with the U.S.
Securities and Exchange Commission (SEC). Genmab does not undertake
any obligation to update or revise forward looking statements in
this annual 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®; HexElect®; and UniBody®. Kesimpta® is a
trademark of Novartis AG or its affiliates. DARZALEX® is a
trademark of Johnson & Johnson. TEPEZZA® is a trademark of
Horizon Therapeutics Ireland DAC.
1Developed in collaboration with Seagen Inc. 2Developed in
collaboration with AbbVie Inc. 3Created and developed in
collaboration with BioNTech SE 4Developed by Janssen Biotech, Inc.
under an exclusive worldwide license from Genmab to develop,
manufacture and commercialize daratumumab 5Developed and marketed
worldwide by Novartis under a license agreement between Genmab and
Novartis Pharma AG 6Developed and manufactured by Horizon
Therapeutics, plc
CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122
Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark
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