TIDMGEN
August 11, 2021; Copenhagen, Denmark;
Interim Report for the First Half of 2021
Highlights
-- The U.S. FDA accepted for Priority Review the tisotumab vedotin Biologics
License Application (BLA), for patients with recurrent or metastatic
cervical cancer
-- DARZALEX(R) net sales increased 52% compared to the first half of 2020 to
USD 2,798 million, resulting in royalty income of DKK 2,360 million
-- Following a positive CHMP opinion, Janssen-Cilag International NV
received European Marketing Authorization for DARZALEX SC (daratumumab
and hyaluronidase-fihj) for adult patients with newly diagnosed
light-chain (AL) amyloidosis
-- Genmab improves its 2021 financial guidance
"Genmab's antibody expertise and innovation were on display
during the second quarter of 2021 with the U.S. FDA's acceptance
for priority review of the BLA for tisotumab vedotin, which we are
developing with Seagen, and with the approval of Janssen's
RYBREVANT(TM) (amivantamab-vmjw), the first regulatory approval for
a product created using Genmab's proprietary DuoBody(R) technology
platform. The majority of Genmab's clinical stage products are
based on our DuoBody technology, and we hope that the approval of
RYBREVANT is just the first validation of many of the potential for
this technology to create effective treatments for patients with
cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab.
Financial Performance First Half of 2021
-- Net sales of DARZALEX by Janssen Biotech, Inc. (Janssen) were USD 2,798
million in the first half of 2021 compared to USD 1,838 million in the
first half of 2020, an increase of USD 960 million, or 52%.
-- Royalty revenue was DKK 2,595 million in the first half of 2021 compared
to DKK 1,738 million in the first half of 2020, an increase of DKK 857
million, or 49%. The increase was driven by higher net sales of DARZALEX,
TEPEZZA(R) and Kesimpta(R) resulting in higher royalties.
-- Total revenue for the first half of 2021 was DKK 3,553 million. In
addition to the royalty revenue described above, Genmab also recognized
DKK 731 million of milestone revenue during the first half of 2021.
Revenue for the first half of 2020 was DKK 6,343 million and included the
one-time upfront payment of DKK 4,398 million recognized as license
revenue from AbbVie Inc. (AbbVie) pursuant to our collaboration announced
in June 2020.
-- Operating expenses were DKK 2,234 million in the first half of 2021
compared to DKK 1,775 million in the first half of 2020. The increase of
DKK 459 million, or 26%, was driven by the continued advancement of
multiple pipeline projects, and the increase in new employees to support
the expansion of our product pipeline and building our commercialization
capabilities and broader organizational infrastructure.
-- Operating result was DKK 1,319 million in the first half of 2021 compared
to DKK 4,568 million in the first half of 2020. The decrease of DKK 3,249
million, or 71%, was driven by lower revenue as a result of the
non-recurring license revenue in 2020 and increased operating expenses.
Outlook
Genmab is improving its 2021 financial guidance published on
February 23, 2021, driven primarily by increased royalty revenue
related to the net sales of DARZALEX.
Revised Previous
(DKK million) Guidance Guidance
---------------------
Revenue 7,300 - 7,900 6,800 - 7,500
Operating expenses (5,500) - (5,800) (5,500) - (5,800)
Operating result 1,500 - 2,400 1,000 - 2,000
Conference Call
Genmab will hold a conference call to discuss the results for
the first half of 2021 today, Wednesday, August 11, at 6:00 pm
CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333 000804
(international participants) and provide conference code
78377092.
A live and archived webcast of the call and relevant slides will
be available at genmab.com/investors
https://www.globenewswire.com/Tracker?data=b2jXf8mjlar7tB401uUEHtbSHFQq3TBH6dB3I47Z8wUa3bNny6E7M46MKc2Dd5hlLBpd8uQ-g_YWWDDvVX1YALxeHkO7DqcMSTKRuIVKFYg=
.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
and Communications
T: +1 609 524 0065; E: mmp@genmab.com
https://www.globenewswire.com/Tracker?data=hh_0sJmNGl7XPRnn9Wy1YnP7l91BHypoINExgNiUhFEioEcp-k2bxDt6ma_vACNIQlpu5LHpxIF764cO60gzcw==
For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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=ae_KlREDDL4oOSvWoHlJdIGe_J4OGwWzcbUE7ZlzIUsJOnbVQ5GziWAEalc5yp8f2_FJpoOX3vQtowPHM3b_Bw==
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.
SEC, which are available at
https://www.globenewswire.com/Tracker?data=ae_KlREDDL4oOSvWoHlJdA-8j3-VhButWlnTHDXKn-UCoXvqHUsmi4c_bfAsfw-W_YmvJz8G344eRtcxYlS5mA==
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) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) and
HexElect(R) , UltiMAb(R) is a trademark of Medarex, Inc.,
Kesimpta(R) and Sensoready(R) are trademarks of Novartis AG or its
affiliates. DARZALEX(R) , DARZALEX FASPRO(R) and RYBREVANT(TM) 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 2021 on
attachment or at www.genmab.com/investors.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 110821_CA60_Genmab Q2 2021 Interim Report
https://ml-eu.globenewswire.com/Resource/Download/d28e8eb4-17c5-47c5-865a-154ebdf00b5c
(END) Dow Jones Newswires
August 11, 2021 11:01 ET (15:01 GMT)
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