Genmab Announces Financial Results for the First Quarter of 2022
11 Maggio 2022 - 5:01PM
May 11,
2022 Copenhagen,
Denmark; Interim Report for the
First Quarter Ended March 31, 2022
Highlights
- DARZALEX® 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®-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® and Kesimpta®
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® 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™ 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® 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.
OutlookGenmab 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 CallGenmab 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 AffairsT: +1 609 524 0065; E:
mmp@genmab.com
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®. Tivdak® is a trademark
of Seagen Inc.; EPCORE™ is a trademark of AbbVie Biotechnology
Ltd.; 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 Quarter of 2022
on attachment or at www.genmab.com/investors.
CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122Genmab A/SKalvebod
Brygge 431560 Copenhagen VDenmark
- 110522_CA17_Q1 2022 Interim Report
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