TIDMGEN
November 10, 2021; Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30,
2021
Highlights
-- The U.S. Food and Drug Administration (U.S. FDA) granted Genmab and
Seagen Inc. (Seagen) accelerated Approval for TIVDAK(TM) (tisotumab
vedotin-tftv) for patients with recurrent or metastatic cervical cancer
-- DARZALEX(R) net sales as reported by Johnson & Johnson increased 49%
compared to the first nine months of 2020 to USD 4,378 million, resulting
in royalty income of DKK 4,167 million
-- Genmab improves its 2021 financial guidance
"The U.S. FDA approval for TIVDAK represents an important
milestone both for the treatment of cervical cancer as well as for
Genmab as a company, " said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab. "TIVDAK is the first and only approved
antibody-drug conjugate (ADC) for adult patients with recurrent or
metastatic cervical cancer with disease progression on or after
chemotherapy, providing a new treatment option for patients
impacted by this devastating disease. The decision by the U.S. FDA
also marks the first regulatory approval for an ADC combining
Genmab's antibody with Seagen's ADC technology and is the first
approval for any therapy owned at least 50% by Genmab. This
achievement was only possible because of the efforts of our
dedicated and talented team, the excellent collaboration with our
partner for TIVDAK, Seagen, and the patients, families and
caregivers as well as the nurses, physicians and study teams who
participated in our clinical trials."
Financial Performance First Nine Months of 2021
-- Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 4,378
million in the first nine months of 2021 compared to USD 2,937 million in
the first nine months of 2020, an increase of USD 1,441 million, or 49%.
-- Royalty revenue was DKK 4,698 million in the first nine months of 2021
compared to DKK 3,090 million in the first nine months of 2020, an
increase of DKK 1,608 million, or 52%. The increase was driven by higher
net sales of DARZALEX, TEPEZZA(R) and Kesimpta(R) resulting in higher
royalties.
-- Total revenue was DKK 5,863 million in the first nine months of 2021. In
addition to the royalty revenue described above, Genmab also recognized
DKK 794 million of milestone revenue during the first nine months of
2021. Revenue for the first nine months of 2020 was DKK 8,067 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 3,654 million in the first nine months of
2021 compared to DKK 2,641 million in the first nine months of 2020. The
increase of DKK 1,013 million, or 38%, was driven by the continued
advancement of multiple pipeline projects, the increase in new employees
to support the launch of TIVDAK and expansion of our product pipeline, as
well as the continued development of commercialization capabilities and
Genmab's broader organizational infrastructure.
-- Operating result was DKK 2,209 million in the first nine months of 2021
compared to DKK 5,426 million in the first nine months of 2020. The
decrease of DKK 3,217 million, or 59%, was driven by lower revenue as a
result of the non-recurring license revenue in 2020 associated with the
upfront payment from AbbVie and increased operating expenses.
Outlook
As announced in Company Announcement No. 66, Genmab is improving
its 2021 financial guidance published on August 11, 2021, driven
primarily by increased royalty revenue related to the net sales of
DARZALEX.
Revised Previous
(DKK million) Guidance Guidance
---------------------
Revenue 7,900 - 8,500 7,300 - 7,900
Operating expenses (5,300) - (5,600) (5,500) - (5,800)
Operating result 2,300 - 3,200 1,500 - 2,400
Conference Call
Genmab will hold a conference call in English to discuss the
results for the first nine months of 2021 today, Wednesday,
November 10, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join
the call dial
+1 631 913 1422 (U.S. participants) or +44 3333000804
(international participants) and provide conference code
90392669.
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 Investor Relations
and Communications
T: +1 609 524 0065; E: mmp@genmab.com
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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
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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=0X7a0vian910aSDZCyTWy9Sij3IPOkmjLgq2egD5LWmiMmiQ7_3SzFrqjrens44DX0MtC2FwHURCsRneAYczAw==
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(TM) is a trademark of Seagen Inc. 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 Nine Months of
2021 on attachment or at www.genmab.com/inve
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.
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 101121_CA67_Q3 2021 Interim Report
https://ml-eu.globenewswire.com/Resource/Download/9a312a6e-5bdd-4e8b-a498-2cc98d7d6aa3
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November 10, 2021 11:00 ET (16:00 GMT)
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