TIDMGEN
August 3, 2023 Copenhagen, Denmark;
Interim Report for the First Six Months Ended June 30, 2023
Highlights
-- EPKINLY(TM) (epcoritamab-bysp) was approved by the U.S. Food and Drug
Administration (U.S. FDA) as the first bispecific antibody to treat
adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
-- Genmab and AbbVie Inc. (AbbVie) announced positive topline results from
the Phase 1/2 EPCORE(TM) NHL-1 trial evaluating epcoritamab in patients
with relapsed/refractory follicular lymphoma (FL)
-- Genmab revenue increased 34% compared to the first six months of 2022, to
DKK 7,052 million
-- Genmab 2023 financial guidance updated
"The U.S. FDA approval of EPKINLY as the first bispecific
antibody to treat adults with relapsed or refractory DLBCL was an
important milestone both for Genmab and for patients in need of an
innovative treatment option administered subcutaneously. We would
like to thank the patients and investigators who took part in the
EPCORE NHL-1 trial that was the basis of this approval, as well as
the unstoppable team at Genmab responsible for the discovery,
development and now commercialization of EPKINLY. We also thank our
partners at AbbVie for their excellent collaboration as we work
together to bring EPKINLY to cancer patients," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2023
-- Net sales of DARZALEX(R) by Janssen Biotech, Inc. (Janssen) were USD
4,695 million in the first six months of 2023 compared to USD 3,842
million in the first six months of 2022, an increase of USD 853 million,
or 22%.
-- Royalty revenue was DKK 5,935 million in the first six months of 2023
compared to DKK 4,727 million in the first six months of 2022, an
increase of DKK 1,208 million, or 26%. The increase in royalties was
driven by higher net sales of DARZALEX and Kesimpta(R).
-- Revenue was DKK 7,052 million for the first six months of 2023 compared
to DKK 5,281 million for the first six months of 2022. The increase of
DKK 1,771 million, or 34%, 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 5,118 million in the first six months of 2023
compared to DKK 3,520 million in the first six months of 2022. The
increase of DKK 1,598 million, or 45%, 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 1,934 million in the first six months of 2023
compared to DKK 1,761 million in the first six months of 2022.
-- Net financial items resulted in income of DKK 75 million for the first
six months of 2023 compared to DKK 1,340 million in the first six months
of 2022. The decrease of DKK 1,265 million, or 94%, 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.
Outlook
As announced in Company Announcement No. 36, Genmab updated its
2023 financial guidance driven by the continued strong growth of
DARZALEX net sales and higher total royalty revenues from DARZALEX
and other marketed products, partly offset by increased and
accelerated investment for epcoritamab clinical trials and
progression of other pipeline products.
Revised Previous
(DKK million) Guidance Guidance
---------------------
Revenue 15,500 - 16,500 14,600 - 16,100
Operating expenses (10,400) - (10,900) (9,800) - (10,600)
Operating profit 4,500 - 6,000* 3,900 - 6,200*
(*Operating profit does not sum due to rounding)
Conference Call
Genmab will hold a conference call in English to discuss the
results for the first half of 2023 today, Thursday, August 3, at
6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. 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/BI9658367403a443db8fda64d31a3cfbc5.
A live and archived webcast of the call and relevant slides will be
available at www.genmab.com/investors.
Contact
Marisol Peron, Senior Vice President, Global Communications
& Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
https://www.globenewswire.com/Tracker?data=Jerof0Ga1SpSed2wvwyZ1hpwkJm20KsNk704CqspoucyKdJa8O_eAd002uNsU3GBkcztJCn4DTHmFA7zRznvjQ==
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
https://www.globenewswire.com/Tracker?data=naalngTOaEC_ocjL-eRDCK9imZJYLNjWSmTq-WPuxMLjNNrcyWmCbWOM16rVIa04sgos2dryDDjcvszVtqw5-g==
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
https://www.globenewswire.com/Tracker?data=A6wEZEJsImfLCyNJCCSM7jgMBVHbXZW3c3tQ2-jQ9GEZ7n05rQHaSgKHWMOovUu89VVi6euEwV-tqWQ0aRYA8g==
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
https://www.globenewswire.com/Tracker?data=A6wEZEJsImfLCyNJCCSM7rD2zpTUYObgNV9gKXrle743PeK-hC_kfGToSvlyA2Lx6N62DiL2OFJL1YLHB2SwDQ==
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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R); DuoBody(R) ;
HexaBody(R) ; DuoHexaBody(R) ; and HexElect(R) . Tivdak(R) is a
trademark of Seagen Inc.; EPCORE(TM) and EPKINLY(TM) are trademarks
of AbbVie Biotechnology Ltd.; Kesimpta(R) and Sensoready(R) are
trademarks of Novartis AG or its affiliates; DARZALEX(R) , DARZALEX
FASPRO(R) , RYBREVANT(R) and TECVAYLI(R) are trademarks of Johnson
& Johnson; TEPEZZA(R) is a trademark of Horizon Therapeutics
Ireland DAC.
Download the full Interim Report for the First Half of 2023 on
attachment or at www.genmab.com/investors.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark
Attachment
-- 030823_CA37_Genmab Q2 2023 Interim Report
https://ml-eu.globenewswire.com/Resource/Download/21a83983-472c-4f9d-a8b4-e843b59618b4
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August 03, 2023 11:01 ET (15:01 GMT)
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