Company Announcement
- Net trade sales of DARZALEX in 2019 totaled USD 2,998
million
- Genmab to receive milestone payment of USD 150 million
in DARZALEX collaboration
- Milestone triggered by sales of DARZALEX reaching USD 3
billion in the calendar year of 2019 as calculated on the basis of
the license agreement terms
Copenhagen, Denmark; January 22, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that worldwide
net trade sales of DARZALEX® (daratumumab) as reported by Johnson
& Johnson were USD 2,998 million in 2019. Net trade
sales were USD 1,567 million in the U.S. and net trade sales in the
rest of the world were USD 1,430 million. Genmab receives royalties
on the worldwide net sales of DARZALEX as calculated on the basis
of the license agreement terms under the exclusive worldwide
license to Janssen Biotech, Inc. (Janssen) to develop, manufacture
and commercialize DARZALEX. Worldwide net trade sales of DARZALEX
in 2018 were USD 2,025 million, resulting in royalty income of DKK
1,708 million to Genmab.
Genmab has also achieved a USD 150 million sales volume
milestone payment triggered by sales of DARZALEX reaching USD 3
billion in the calendar year of 2019 as calculated on the basis of
the license agreement terms. Under the license agreement, DARZALEX
sales are calculated based on a hedged foreign exchange rate and as
such are different than net trade sales reported by Johnson &
Johnson. The difference was mainly due to the translation of sales
denominated in currencies other than USD into USD under the license
agreement. No further sales volume milestones are due under the
license agreement.
“We are extremely pleased that DARZALEX continued its solid
sales growth in 2019, as it is indicative of the strong benefit
DARZALEX provides across its many indications in multiple myeloma,”
said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
“We are grateful to our partner for DARZALEX, Janssen, and their
continued efforts to ensure that this treatment is made available
to all the many patients who might benefit from it.”
The milestone was included in the original financial guidance
issued by Genmab on February 20, 2019, and in the improved
financial guidance issued on November 6, 2019, as such there is no
change to the company’s financial guidance for 2019.
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) intravenous
infusion is indicated for the treatment of adult patients in the
United States: in combination with bortezomib, thalidomide and
dexamethasone as treatment for patients newly diagnosed with
multiple myeloma who are eligible for autologous stem cell
transplant; in combination with lenalidomide and dexamethasone for
the treatment of patients with newly diagnosed multiple myeloma who
are ineligible for autologous stem cell transplant; in combination
with bortezomib, melphalan and prednisone for the treatment of
patients with newly diagnosed multiple myeloma who are ineligible
for autologous stem cell transplant; in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone,
for the treatment of patients with multiple myeloma who have
received at least one prior therapy; in combination with
pomalidomide and dexamethasone for the treatment of patients with
multiple myeloma who have received at least two prior therapies,
including lenalidomide and a proteasome inhibitor (PI); and as a
monotherapy for the treatment of patients with multiple myeloma who
have received at least three prior lines of therapy, including a PI
and an immunomodulatory agent, or who are double-refractory to a PI
and an immunomodulatory agent.1 DARZALEX is the first monoclonal
antibody (mAb) to receive U.S. Food and Drug Administration (U.S.
FDA) approval to treat multiple myeloma. DARZALEX intravenous
infusion is indicated for the treatment of adult patients in
Europe: in combination with bortezomib, thalidomide and
dexamethasone as treatment for patients newly diagnosed with
multiple myeloma who are eligible for autologous stem cell
transplant; in combination with lenalidomide and dexamethasone for
the treatment of patients with newly diagnosed multiple myeloma who
are ineligible for autologous stem cell transplant; in combination
with bortezomib, melphalan and prednisone for the treatment of
adult patients with newly diagnosed multiple myeloma who are
ineligible for autologous stem cell transplant; for use in
combination with lenalidomide and dexamethasone, or bortezomib and
dexamethasone, for the treatment of adult patients with multiple
myeloma who have received at least one prior therapy; and as
monotherapy for the treatment of adult patients with relapsed and
refractory multiple myeloma, whose prior therapy included a PI and
an immunomodulatory agent and who have demonstrated disease
progression on the last therapy2. The option to split the first
infusion of DARZALEX over two consecutive days has been approved in
both Europe and the U.S. In Japan, DARZALEX intravenous infusion is
approved for the treatment of adult patients: in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone for
the treatment of relapsed or refractory multiple myeloma; in
combination with bortezomib, melphalan and prednisone for the
treatment of patients with newly diagnosed multiple myeloma who are
ineligible for autologous stem cell transplant; in combination with
lenalidomide and dexamethasone for the treatment of patients with
newly diagnosed multiple myeloma who are ineligible for autologous
stem cell transplant. DARZALEX is the first human CD38 monoclonal
antibody to reach the market in the United States, Europe and
Japan. For more information, visit www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that
binds with high affinity to the CD38 molecule, which is highly
expressed on the surface of multiple myeloma cells. Daratumumab
triggers a person’s own immune system to attack the cancer cells,
resulting in rapid tumor cell death through multiple
immune-mediated mechanisms of action and through immunomodulatory
effects, in addition to direct tumor cell death, via apoptosis
(programmed cell death).1,2,3,4,5,6
Daratumumab is being developed by Janssen Biotech, Inc. under an
exclusive worldwide license to develop, manufacture and
commercialize daratumumab from Genmab. A comprehensive clinical
development program for daratumumab is ongoing, including multiple
Phase III studies in smoldering, relapsed and refractory and
frontline multiple myeloma settings. Additional studies are ongoing
or planned to assess the potential of daratumumab in other
malignant and pre-malignant diseases in which CD38 is expressed,
such as amyloidosis, NKT-cell lymphoma and T-cell ALL. Daratumumab
has received two Breakthrough Therapy Designations from the U.S.
FDA for certain indications of multiple myeloma, including as a
monotherapy for heavily pretreated multiple myeloma and in
combination with certain other therapies for second-line treatment
of multiple myeloma.
About Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company has two approved
antibodies, DARZALEX® (daratumumab) for the treatment of certain
multiple myeloma indications, and Arzerra® (ofatumumab) for the
treatment of certain chronic lymphocytic leukemia indications.
Daratumumab is in clinical development for additional multiple
myeloma indications, other blood cancers and amyloidosis. A
subcutaneous formulation of ofatumumab is in development for
relapsing multiple sclerosis. Genmab also has a broad clinical and
pre-clinical product pipeline. Genmab's technology base consists of
validated and proprietary next generation antibody technologies -
the DuoBody® platform for generation of bispecific antibodies, the
HexaBody® platform, which creates effector function enhanced
antibodies, the HexElect® platform, which combines two
co-dependently acting HexaBody molecules to introduce selectivity
while maximizing therapeutic potency and the DuoHexaBody® platform,
which enhances the potential potency of bispecific antibodies
through hexamerization. The company intends to leverage these
technologies to create opportunities for full or co-ownership of
future products. Genmab has alliances with top tier pharmaceutical
and biotechnology companies. Genmab is headquartered in Copenhagen,
Denmark with core sites in Utrecht, the Netherlands and Princeton,
New Jersey, U.S.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
This Company Announcement 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 final prospectus for our U.S. public offering and listing
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 this Company Announcement 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®; HexElect®; and UniBody®. Arzerra® is
a trademark of Novartis AG or its affiliates. DARZALEX® is a
trademark of Janssen Pharmaceutica NV.
1 DARZALEX Prescribing information, September 2019. Available
at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf
Last accessed September 20192 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed October 20193 De Weers, M et al. Daratumumab, a Novel
Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of
Multiple Myeloma and Other Hematological Tumors. The Journal of
Immunology. 2011; 186: 1840-1848.4 Overdijk, MB, et al.
Antibody-mediated phagocytosis contributes to the anti-tumor
activity of the therapeutic antibody daratumumab in lymphoma and
multiple myeloma. MAbs. 2015; 7: 311-21.5 Krejcik MD et al.
Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell
Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood.
2016; 128: 384-94.6 Jansen, JH et al. Daratumumab, a human
CD38 antibody induces apoptosis of myeloma tumor cells via Fc
receptor-mediated crosslinking. Blood. 2012; 120(21): abstract
2974.
Company Announcement no. 04CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 220120_CA04_DARZALEX FY 19 Sales_Milestone
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