TIDMGEN
May 11, 2022 Copenhagen, Denmark;
Interim Report for the First Quarter Ended March 31, 2022
Highlights
-- DARZALEX(R) net sales as reported by Johnson & Johnson increased 36%
compared to the first three months of 2021 to USD 1,856 million,
resulting in royalty revenue of DKK 1,501 million
-- Genmab updates its 2022 financial guidance
"During the first quarter of 2022, there were continued
advancements in our pipeline, including the first patient dosed
with DuoBody(R) -CD3xB7H4 (GEN1047), the presentation of data from
the tisotumab vedotin innovaTV 207 study, and the U.S. Food and
Drug Administration (U.S. FDA) granting orphan-drug designation to
epcoritamab for the treatment of follicular lymphoma (FL). Together
these events help to progress us further in our evolution into a
fully integrated biotech innovation powerhouse," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter of 2022
-- Net sales of DARZALEX by Janssen were USD 1,856 million in the first
three months of 2022 compared to USD 1,365 million in the first three
months of 2021, an increase of USD 491 million, or 36%.
-- Royalty revenue was DKK 1,836 million in the first three months of 2022
compared to DKK 1,017 million in the first three months of 2021, an
increase of DKK 819 million, or 81%. The increase was driven by higher
net sales of DARZALEX, TEPEZZA(R) and Kesimpta(R) resulting in higher
royalties.
-- Revenue was DKK 2,119 million for the first three months of 2022 compared
to DKK 1,581 million for the first three months of 2021. The increase of
DKK 538 million, or 34%, was primarily driven by higher DARZALEX, TEPEZZA
and Kesimpta royalties achieved under our collaborations with Janssen,
Roche and Novartis, respectively, partly offset by milestones achieved
under our collaborations with AbbVie and Janssen in the first three
months of 2021.
-- Operating expenses were DKK 1,605 million in the first three months of
2022 compared to DKK 1,049 million in the first three months of 2021. The
increase of DKK 556 million, or 53%, was driven by the continued
advancement of multiple pipeline projects, the increase in new employees
to support Tivdak(R) post launch and expansion of our product pipeline,
as well as the continued development of commercialization capabilities
and Genmab's broader organizational infrastructure.
-- Operating profit was DKK 514 million in the first three months of 2022
compared to DKK 532 million in the first three months of 2021.
Subsequent Events
-- April: Genmab and AbbVie Inc. (AbbVie) announced topline results for
epcoritamab from the first cohort of the EPCORE(TM) NHL-1 phase 1/2
clinical trial evaluating epcoritamab. The study cohort includes 157
patients with relapsed / refractory large B-cell lymphoma who received at
least two prior lines of systemic therapy, including 38.9% who received
prior treatment with chimeric antigen receptor T-cell therapy. The
topline results from this cohort demonstrated an overall response rate of
63.1% as confirmed by an independent review committee, which exceeded the
protocol prespecified threshold for efficacy. The observed median
duration of response was 12 months. The most common treatment-emergent
adverse event was cytokine release syndrome with 49.7%, including 2.5%
grade 3. Based on the topline results, the companies will engage global
regulatory authorities to determine next steps.
-- April: The arbitral tribunal issued an award in the binding arbitration
of two matters arising under Genmab's license agreement with Janssen
relating to daratumumab. Genmab did not seek a review of the award, and
the award is now final. The arbitral tribunal decided both issues in
favor of Janssen. The first issue concerned the question as to whether
Janssen's obligation to pay royalties on sales of licensed product
extends, in each applicable country, until the expiration or invalidation
of the last-to-expire relevant Genmab-owned patent or the last-to-expire
relevant Janssen-owned patent covering the product, as further defined
and described in the license agreement. As to that issue, the tribunal
determined by majority opinion that Janssen's obligation to pay royalties
to Genmab on sales of licensed product, in each applicable country,
extends through the expiration or invalidation of the last-to-expire
relevant Genmab-owned patent covering the product or use thereof, but not
the relevant Janssen-owned patent. The relevant Genmab-owned issued U.S.,
European and Japanese patents will expire in the late 2020s and early
2030s. The second issue concerned the question as to whether Genmab is
required to share in Janssen's royalty payments to Halozyme Therapeutics,
Inc. (Halozyme) for the Halozyme enzyme technology used in the
subcutaneous (SC) formulation of daratumumab (marketed as DARZALEX
FASPRO(R) in the U.S.). The royalties Janssen pays to Halozyme represent
a mid-single digit percentage rate of SC daratumumab sales. As to that
issue, the tribunal ruled by majority opinion that Janssen is permitted
to continue reducing its royalty payments to Genmab as an offset against
a share of Janssen's royalty payments made to Halozyme.
Outlook
Genmab is updating the lower end of its 2022 financial guidance
published on February 16, 2022, driven by increased royalty revenue
related to net sales of DARZALEX.
Revised Previous
(DKK million) Guidance Guidance
---------------------
Revenue 11,000 - 12,000 10,800 - 12,000
Operating expenses (7,200) - (7,800) (7,200) - (7,800)
Operating profit 3,200 - 4,800 3,000 - 4,800
Conference Call
Genmab will hold a conference call in English to discuss the
results for the first quarter of 2022 today, Wednesday, May 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 3333000804
(international participants) and provide conference code 48414786.
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=WsnAyiLgYg_lctx4f-7U-_JAOg3RZaeHmAmoiqyH3z9Fj6E82h7biYc5xUzJTpuo_Xowjmb-7USwB5yBx-G8cw==
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
https://www.globenewswire.com/Tracker?data=xW_g9ZGe-iNrk8jw4bxmnrIIRWVWZ9jV8W-VPZwzc_h87rJDpF7eFxwgDdt-gNV_Ad5w-R5RL7jR7pM7eezZJw==
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(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 Quarter 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
-- 110522_CA17_Q1 2022 Interim Report
https://ml-eu.globenewswire.com/Resource/Download/2d2588be-2057-4987-9a3f-9d7a04f5742b
(END) Dow Jones Newswires
May 11, 2022 11:01 ET (15:01 GMT)
Copyright (c) 2022 Dow Jones & Company, Inc.
Genuit (LSE:GEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Genuit (LSE:GEN)
Historical Stock Chart
From Apr 2023 to Apr 2024