Genmab Announces Financial Results for the First Half of 2021
August 11 2021 - 11:01AM
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® 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™ (amivantamab-vmjw), the first regulatory approval for a
product created using Genmab’s proprietary DuoBody® 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® and Kesimpta® 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.
OutlookGenmab 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.
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. 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®, UltiMAb® is a trademark
of Medarex, 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 Half of 2021 on attachment or at
www.genmab.com/investors.
CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122Genmab A/SKalvebod
Brygge 431560 Copenhagen VDenmark
- 110821_CA60_Genmab Q2 2021 Interim Report
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