TIDMGEN
November 9, 2022 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30,
2022
Highlights
-- Genmab revenue increased 60% compared to the first nine months of 2021,
to DKK 9,368 million
-- Genmab improves its 2022 financial guidance
"During the first nine months of the year we continued to build
on Genmab's consistent track record of success. We have
strengthened our pipeline, our team and our financial foundation is
even more robust. We are pleased with the recent U.S. and European
regulatory submissions for epcoritamab. These submissions are an
important step in potentially bringing epcoritamab to people living
with certain hematologic malignancies who are in need of a new
treatment option," said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab.
Financial Performance First Nine Months of 2022
-- Net sales of DARZALEX(R) by Janssen Biotech, Inc. (Janssen) were USD
5,894 million in the first nine months of 2022 compared to USD 4,378
million in the first nine months of 2021, an increase of USD 1,516
million, or 35%.
-- Royalty revenue was DKK 8,207 million in the first nine months of 2022
compared to DKK 4,698 million in the first nine months of 2021, an
increase of DKK 3,509 million, or 75%. The increase in royalties was
driven by higher net sales of DARZALEX, Kesimpta(R) and TEPEZZA(R) and a
higher average exchange rate between the USD and DKK.
-- Revenue was DKK 9,368 million for the first nine months of 2022 compared
to DKK 5,863 million for the first nine months of 2021. The increase of
DKK 3,505 million, or 60%, was primarily driven by higher DARZALEX,
Kesimpta and TEPEZZA royalties achieved under our collaborations with
Janssen, Novartis Pharma AG (Novartis) and Roche, respectively, an
increase in Tivdak(R) collaboration revenue, and reimbursement revenue
driven by higher activities under our collaboration agreements with
BioNTech SE (BioNTech), partly offset by milestones achieved under our
collaborations with Janssen and AbbVie in the first nine months of 2021.
-- Operating expenses were DKK 5,676 million in the first nine months of
2022 compared to DKK 3,654 million in the first nine months of 2021. The
increase of DKK 2,022 million, or 55%, was driven by the continued
advancement of epcoritamab and multiple pipeline projects, an increase in
team members to support Tivdak 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 3,692 million in the first nine months of 2022
compared to DKK 2,209 million in the first nine months of 2021.
-- Net financial items was income of DKK 2,681 million for the first nine
months of 2022 compared to income of DKK 808 million in the first nine
months of 2021. The increase of DKK 1,873 million was primarily driven by
net foreign exchange rate gains due to the USD strengthening against the
DKK.
Epcoritamab Regulatory Update
There were two regulatory submissions for epcoritamab in the
second half of 2022. Genmab submitted a biologics license
application (BLA) to the U.S. Food and Drug Administration (U.S.
FDA) for subcutaneous (SC) epcoritamab for the treatment of
patients with relapsed/refractory large B-cell lymphoma (LBCL)
after two or more lines of systemic therapy. Additionally, AbbVie
submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for SC epcoritamab for the
treatment of patients with relapsed/refractory diffuse large B-cell
lymphoma (DLBCL) after two or more lines of systemic therapy, which
has been validated by the EMA. Both submissions were supported by
results from the LBCL cohort of the pivotal EPCORE(TM) NHL-1
open-label, multi-center trial evaluating the safety and
preliminary efficacy of epcoritamab in patients with relapsed,
progressive or refractory CD20+ mature B-cell non-Hodgkin lymphoma
(B-NHL), including DLBCL.
Outlook
As announced in Company Announcement No. 54, Genmab is improving
its 2022 financial guidance published on August 8, 2022, driven
primarily by the positive foreign exchange rate impact on our
royalty revenue, and the continued strong performance of DARZALEX
net sales.
Revised Previous
(DKK million) Guidance Guidance
---------------------
Revenue 13,500 - 14,500 12,000 - 13,000
Operating expenses (8,000) - (8,400) (7,600) - (8,200)
Operating profit 5,100 - 6,500 3,800 - 5,400
Conference Call
Genmab will hold a conference call in English to discuss the
results for the first nine months of 2022 today, Wednesday,
November 9, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join
the call please use the below registration link. Registered
participants will receive an email with a link to access dial-in
information as well as a unique personal PIN:
https://register.vevent.com/register/BI2f752c494cf441f8b2fd8379c5219dc7.
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
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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=tNSVHkdFByuFpp972Kp3GDKGBuBcVwO92vNvsvG6GMwNma7JQASOdPsC_wWLX1B9ZNcagdngpntdDsmnrBf9jA==
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=tNSVHkdFByuFpp972Kp3GAkco974GscYmfjzbEA30_Su0nmc0f5ZjnfhSOvDUo7C7c9UuvGA2BLa4P1kohgI0Q==
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) RYBREVANT(R) and TECVAYLI(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
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
-- 091122_CA55_Genmab Q3 2022 Interim Report
https://ml-eu.globenewswire.com/Resource/Download/5f04a95b-1918-4ca8-b059-5f98ac05f9e8
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