TIDMGEN
August 10, 2022 Copenhagen, Denmark;
Interim Report for the First Six Months Ended June 30, 2022
Highlights
-- Genmab and AbbVie Inc. (AbbVie) announced topline results for epcoritamab
from the Phase 1/2 trial in patients with relapsed/refractory large
B-cell lymphoma (LBCL)
-- Genmab announced its intent to submit a biologics license application
(BLA) to the U.S. Food and Drug Administration (U.S. FDA) for epcoritamab
for the treatment of patients with relapsed/refractory LBCL, in the
second half of 2022
-- DARZALEX(R) net sales as reported by Johnson & Johnson increased 37%
compared to the first six months of 2021 to USD 3,842 million, resulting
in royalty revenue to Genmab of DKK 4,024 million
-- Genmab announced the resolution of its arbitration with Janssen Biotech,
Inc. (Janssen) under its daratumumab license agreement and subsequently
commenced a new arbitration under the daratumumab license agreement with
Janssen
-- Genmab improves its 2022 financial guidance
"Genmab's innovation was on display during the second quarter of
2022 with data presentations at multiple prestigious conferences
and the publication by Genmab, and our partner, AbbVie, of topline
results for epcoritamab from the Phase 1/2 trial in patients with
relapsed/refractory LBCL. Based on this data, we intend to submit a
BLA to the U.S. FDA for epcoritamab in the second half of this
year," said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab.
Financial Performance First Half of 2022
-- Net sales of DARZALEX by Janssen were USD 3,842 million in the first six
months of 2022 compared to USD 2,798 million in the first six months of
2021, an increase of USD 1,044 million, or 37%.
-- Royalty revenue was DKK 4,727 million in the first six months of 2022
compared to DKK 2,595 million in the first six months of 2021, an
increase of DKK 2,132 million, or 82%. The increase in royalties was
driven by higher net sales of DARZALEX, TEPEZZA(R) and Kesimpta(R) and
higher average exchange rate between the USD and DKK.
-- Revenue was DKK 5,281 million for the first six months of 2022 compared
to DKK 3,553 million for the first six months of 2021. The increase of
DKK 1,728 million, or 49%, was primarily driven by higher DARZALEX,
TEPEZZA and Kesimpta royalties achieved under our collaborations with
Janssen, Roche and Novartis Pharma AG (Novartis), respectively, partly
offset by milestones achieved under our collaborations with Janssen and
AbbVie in the first six months of 2021.
-- Operating expenses were DKK 3,520 million in the first six months of 2022
compared to DKK 2,234 million in the first six months of 2021. The
increase of DKK 1,286 million, or 58%, was driven by the continued
advancement of epcoritamab and multiple pipeline projects, an increase in
new employees to support Tivdak(R) post launch and expansion of our
product pipeline, and the continued development of Genmab's
commercialization and broader organizational capabilities and
infrastructure.
-- Operating profit was DKK 1,761 million in the first six months of 2022
compared to DKK 1,319 million in the first six months of 2021.
Outlook
As announced in Company Announcement No. 40, Genmab is raising
its 2022 financial guidance published on May 11, 2022, driven
primarily by increased royalty revenue due to higher net sales of
DARZALEX and the foreign exchange impact of the strong US
Dollar.
Revised Previous
(DKK million) Guidance Guidance
---------------------
Revenue 12,000 - 13,000 11,000 - 12,000
Operating expenses (7,600) - (8,200) (7,200) - (7,800)
Operating profit 3,800 - 5,400 3,200 - 4,800
Conference Call
Genmab will hold a conference call in English to discuss the
results for the first half of 2022 today, Wednesday, August 10, 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 3333000804
(international participants) and provide conference code 29756170.
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, Communications and
Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
https://www.globenewswire.com/Tracker?data=tGwkHBmVaRIU0mrY-Nprz9uh_bTMGIZ80oMqMz-sh16VCkWn1RhD-iWzwszrQtKD1oVR6Cck7SCcsDr2PHZOxg==
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
https://www.globenewswire.com/Tracker?data=otEPMFR9UEwgamsa431wW8iCtMRCFBGQ5-_t1PryTNNWZkT2Pz73Vr9_tAHmEwytaj8UmVaXrNnKEOe-z3QTbA==
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=8Vq_yEPxvLZVdsKDPRIEsRHm8VkzxqKVjRt1L6gmU2rVzDba9o1ogA6ixYa7XTgECsVBimK-337FKL4zARLf_g==
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=8Vq_yEPxvLZVdsKDPRIEseMGKqhRnwu0oBrPNHVCclhG5C0k2H0ofkLVGVxcdY49rVfNlIisaZuev0QwX7qiug==
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) . Tivdak(R) is a trademark of Seagen Inc.; EPCORE(TM)
is a trademark of AbbVie Biotechnology Ltd.; Kesimpta(R) and
Sensoready(R) are trademarks of Novartis AG or its affiliates;
DARZALEX(R) , DARZALEX FASPRO(R) and RYBREVANT(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 2022 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
-- 100822_CA41_Genmab Q2 2022 Interim Report
https://ml-eu.globenewswire.com/Resource/Download/93ae0f6f-e151-4b20-9563-422cd4f4aa3d
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