Genmab Announces Financial Results for the First Nine Months of 2021
11 11월 2021 - 1:00AM
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™ (tisotumab
vedotin-tftv) for patients with
recurrent or metastatic cervical cancer
- DARZALEX® 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® and Kesimpta®
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.
OutlookAs 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 CallGenmab 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
For Investor Relations: 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®; DuoBody in combination
with the DuoBody logo®; HexaBody®; HexaBody in combination with the
HexaBody logo®; DuoHexaBody®; and HexElect®. TIVDAKTM is a
trademark of Seagen Inc. Kesimpta® and Sensoready® are trademarks
of Novartis AG or its affiliates. DARZALEX®, DARZALEX FASPRO® and
RYBREVANT® 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
2021 on attachment or at www.genmab.com/investors.
CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122Genmab A/SKalvebod
Brygge 431560 Copenhagen VDenmark
- 101121_CA67_Q3 2021 Interim Report
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