Company Announcement
COPENHAGEN, Denmark; February 14, 2024 –
Genmab A/S (Nasdaq: GMAB) announced today
the publication of its Annual Report for 2023. 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.
Conference CallGenmab 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.
RevenueGenmab 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 ExpensesGenmab 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 ProfitGenmab 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.
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
x.com/Genmab.Contact:
Marisol Peron, Senior Vice President, Global Communications &
Corporate AffairsT: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +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
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 products or technologies obsolete,
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 on www.genmab.com 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), which are available at www.sec.gov. Genmab does
not undertake any obligation to update or revise forward looking
statements in the 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 KYSO®. Tivdak® is a trademark of
Seagen Inc.; Arzerra® is a trademark of Novartis Pharma AG.
Kesimpta® and Sensoready® are trademarks of Novartis AG or its
affiliates; DARZALEX®, DARZALEX FASPRO®, RYBREVANT®, TECVAYLI® and
TALVEY™ are trademarks of Johnson & Johnson; EPCORE™, EPKINLY®,
TEPKINLY® and their designs are trademarks of AbbVie Biotechnology
Ltd.; TEPEZZA® is a trademark of Horizon Therapeutics Ireland DAC.
©2023, Genmab A/S. All rights reserved.
CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122Genmab A/S Carl
Jacobsens Vej 30 2500 Valby Denmark
1 In March 2023, Genmab’s partner Seagen Inc. (Seagen)
announced that it would be acquired by Pfizer. Pfizer closed the
acquisition of Seagen on December 14, 2023. All references to
Seagen in this announcement have been updated to Pfizer.
- GMAB_2023_Annual_Report_140224
- 529900MTJPDPE4MHJ122-2023-12-31-en
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