Genmab Announces Financial Results for the First Nine Months of 2023
07 Novembre 2023 - 5:01PM
November 7, 2023 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September
30, 2023
Highlights
- Epcoritamab
(TEPKINLY®) was granted
conditional marketing authorization by the European Commission (EC)
to treat adults with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL) after two or more lines of systemic
therapy
- Epcoritamab
(EPKINLY™) was approved by the
Japan Ministry of Health, Labour and Welfare to treat adults with
certain types of relapsed or refractory large B-cell lymphoma
(LBCL) after two or more lines of systemic therapy
- Genmab and Seagen Inc. (Seagen) announced that the
Phase 3 innovaTV 301 confirmatory trial of tisotumab vedotin for
the treatment of recurrent or metastatic cervical cancer met its
primary endpoint of improved overall survival (OS) at a
predetermined, independent interim analysis
- Genmab revenue increased 26% compared to the first nine
months of 2022, to DKK 11,796 million
- Genmab 2023 financial guidance updated
“With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY
is the first Genmab-owned medicine to become available to patients
outside of the United States. In addition to being an important
milestone for Genmab, these approvals mark an important milestone
for patients in these territories who are in need of alternative
therapeutic options,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab. “We look forward to continue to work
with our partner, AbbVie Inc. (AbbVie), to further explore
epcoritamab as a potential future core therapy across B-cell
malignancies.”
Financial Performance First Nine Months of
2023
- Net sales of DARZALEX® by Janssen Biotech, Inc. (Janssen) were
USD 7,194 million in the first nine months of 2023 compared to USD
5,894 million in the first nine months of 2022, an increase of USD
1,300 million, or 22%.
- Royalty revenue was DKK 9,803 million in the first nine months
of 2023 compared to DKK 8,207 million in the first nine months of
2022, an increase of DKK 1,596 million, or 19%. The increase in
royalties was driven by higher net sales of DARZALEX and Kesimpta®,
partly offset by negative foreign exchange rate impacts due to a
lower average exchange rate between the USD and DKK.
- Revenue was DKK 11,796 million for the first nine months of
2023 compared to DKK 9,368 million for the first nine months of
2022. The increase of DKK 2,428 million, or 26%, was primarily
driven by higher DARZALEX and Kesimpta royalties achieved under our
collaborations with Janssen and Novartis Pharma AG (Novartis),
respectively, a milestone achieved under our collaboration with
AbbVie for the first commercial sale of EPKINLY in the United
States, and higher reimbursement revenue driven by increased
activities under our collaboration with BioNTech SE
(BioNTech).
- Operating expenses were DKK 8,045 million in the first nine
months of 2023 compared to DKK 5,676 million in the first nine
months of 2022. The increase of DKK 2,369 million, or 42%, was
driven by the expansion of our product pipeline, EPKINLY launch in
the U.S., the continued development of Genmab’s broader
organizational capabilities, and related increase in team members
to support these activities.
- Operating profit was DKK 3,651 million in the first nine months
of 2023 compared to DKK 3,692 million in the first nine months of
2022.
- Net financial items resulted in income of DKK 1,060 million for
the first nine months of 2023 compared to DKK 2,681 million in the
first nine months of 2022. The decrease of DKK 1,621 million, or
60%, was primarily driven by movements in USD to DKK foreign
exchange rates impacting Genmab’s USD denominated cash and cash
equivalents, and marketable securities in the respective
periods.
OutlookGenmab is updating the lower end of its
revenue and operating expenses of its 2023 financial guidance
driven by higher total royalty revenues from DARZALEX and other
marketed products and increased and accelerated investment for
epcoritamab clinical trials and progression of other pipeline
products.
|
|
|
|
|
|
|
Revised |
|
Previous |
(DKK million) |
|
Guidance |
|
Guidance |
Revenue |
|
15,900 - 16,500 |
|
15,500 - 16,500 |
Operating expenses |
|
(10,600) - (10,900) |
|
(10,400) - (10,900) |
Operating profit* |
|
4,800 – 5,750 |
|
4,500 - 6,000 |
*Operating profit includes DKK~0.2 billion of cost of product
sales, which is not classified within operating expenses
Conference CallGenmab will hold a conference
call in English to discuss the results for the first nine months of
2023 today, Tuesday, November 7, at 6:00 pm CET, 5:00 pm GMT or
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/BIa45c5d7cd5384835a879e0ab083d0577.
A live and archived webcast of the call and relevant slides will be
available at www.genmab.com/investors.
ContactMarisol 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 Interim 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 Interim
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®; HexaBody®; DuoHexaBody®;
HexElect® and KYSO™; Tivdak® is a trademark of Seagen Inc.;
EPCORE™, EPKINLY™, TEPKINLY® and their designs are trademarks of
AbbVie Biotechnology Ltd.; Kesimpta® and Sensoready® are trademarks
of Novartis AG or its affiliates; DARZALEX®, DARZALEX FASPRO®,
RYBREVANT®, TECVAYLI® and TALVEY® are trademarks of Johnson &
Johnson; TEPEZZA® is a trademark of Horizon Therapeutics Ireland
DAC.
Download the full Interim Report for the First Nine Months of
2023 on attachment or at www.genmab.com/investors.
CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122
Genmab A/SCarl Jacobsens Vej 302500 Valby Denmark
- 071123_CA44_Genmab Q3 2023 Interim Report
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