Genmab Achieves USD 25 Million Milestone for First Commercial Sale of DARZALEX (daratumumab) in Japan and Updates Financial Guidance
Genmab Achieves USD 25 Million Milestone for First Commercial Sale of DARZALEX
(daratumumab) in Japan and Updates Financial Guidance
-- First commercial sale of DARZALEX in Japan triggers USD 25 million in
milestone payments from Janssen
-- Financial guidance updated
Copenhagen, Denmark; November 14, 2017 Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that the first commercial sale of DARZALEX (daratumumab) in
Japan has taken place, triggering USD 25 million in milestone payments from
Janssen Biotech, Inc. (Janssen). The milestone was mentioned at the time of the
September 2017 announcement of the approval of DARZALEX for the treatment of
adults with relapsed or refractory multiple myeloma in Japan. As a result of
this milestone, Genmab is updating its 2017 financial guidance.
Were pleased that DARZALEX is now commercially available for patients with
relapsed or refractory multiple myeloma who are living in Japan, said Jan van
de Winkel, Ph.D., Chief Executive Officer of Genmab.
MDKK Revised Guidance Previous Guidance
Revenue 2,110 2,310 1,950 2,150
Operating expenses (1,000) 1,100) (1,000) (1,100)
Operating income 1,060 1,260 900 1,100
Cash position at end of year* 4,900 4,500
*Cash, cash equivalents, and marketable securities
Genmab is improving its 2017 financial guidance last published on November 8,
2017 due to the inclusion of the DARZALEX milestones totaling USD 25 million
associated with first commercial sale of DARZALEX in Japan.
We expect our 2017 revenue to be in the range of DKK 2,110 2,310 million, an
increase of DKK 160 million compared to the previous guidance. We have
increased our projected daratumumab milestones to DKK 960 million (previously
DKK 800 million) due to inclusion of USD 25 million in milestone payments
triggered by the first commercial sale of DARZALEX in Japan. We expect
DARZALEX royalties to remain in the range of DKK 930 1,100 million, which are
based on an estimated USD 1,100 1,300 million of DARZALEX sales in 2017. The
remainder of the revenue mainly consists of Arzerra royalties, DuoBody
milestones, and non-cash amortization of deferred revenue.
We anticipate that our 2017 operating expenses will remain in the range of DKK
1,000 1,100 million.
As a result of the increased revenue, we now expect the operating income for
2017 to be approximately DKK 1,060 1,260 million, compared to DKK 900 1,100
million in the previous guidance.
As a result of the above and proceeds from the exercise of warrants during the
year, we are now projecting a cash position at the end of 2017 of greater than
DKK 4,900 million.
Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to
change due to numerous reasons, including but not limited to the achievement of
certain milestones associated with our collaboration agreements; the timing and
variation of development activities (including activities carried out by our
collaboration partners) and related income and costs; DARZALEX and Arzerra
sales and corresponding royalties to Genmab; fluctuations in the value of our
marketable securities; and currency exchange rates. The financial guidance does
not include any potential proceeds from future warrant exercises and also
assumes that no significant agreements are entered into during 2017 that could
materially affect the results.
About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the
United States 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 (FDA) approval to treat
multiple myeloma. DARZALEX is indicated in Europe 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 therapy. In Japan, DARZALEX is approved in combination with lenalidomide
and dexamethasone, or bortezomib and dexamethasone, for treatment of adults
with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38
monoclonal antibody to reach the market. For more information, visit
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 persons 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
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, including multiple Phase
III studies, is ongoing with daratumumab in relapsed and frontline multiple
myeloma settings, and additional studies are ongoing or planned to assess its
potential in other malignant and pre-malignant diseases on which CD38 is
expressed, such as smoldering myeloma, NKT-cell lymphoma, amyloidosis,
myelodysplastic syndromes and solid tumors. Daratumumab has received two
Breakthrough Therapy Designations from the U.S. FDA, for multiple myeloma, as
both a monotherapy and in combination with other therapies.
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 solid tumors.
A subcutaneous formulation of ofatumumab is in development for relapsing
multiple sclerosis. Genmab also has a broad clinical and pre-clinical product
pipeline. Genmabs technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody platform for generation of
bispecific antibodies, and the HexaBody platform which creates effector
function enhanced antibodies. 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. For more information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
T: +45 33 44 77 20; M: +45 25 12 62 60; E: email@example.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 obsolete,
and other factors. For a further discussion of these risks, please refer to the
risk management sections in Genmabs most recent financial reports, which are
available on www.genmab.com. Genmab does not undertake any obligation to update
or revise forward looking statements in this Company Announcement nor to
confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab; the
Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo;
the DuoBody logo; the HexaBody logo; HuMax; HuMax-CD20; DuoBody; HexaBody
and UniBody. Arzerra is a trademark of Novartis AG or its affiliates.
DARZALEX is a trademark of Janssen Biotech, Inc.
1 DARZALEX Prescribing information, June 2017. Available at:
accessed June 2017
2 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.
3 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.
4 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.
5 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of
myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;
Company Announcement no. 40
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