Genmab Announces Financial Results for the First Quarter of 2014
COPENHAGEN, Denmark, May 7, 2014 (GLOBE NEWSWIRE) --
Interim Report First Quarter 2014
*Arzerra(r) (ofatumumab) was approved by the FDA in combination with
chlorambucil for previously untreated patients with chronic lymphocytic
leukemia (CLL) for whom fludarabine-based therapy is considered
*Achieved USD 22 million milestone payment under Janssen Biotech, Inc.
collaboration for daratumumab
*Announced two Phase III studies for daratumumab in multiple myeloma
*Successful international equity private placement
*Improved operating result by DKK 67 million over first quarter 2013
*Original guidance improved
"During the first quarter, we made substantial progress towards meeting our
2014 goals. We successfully launched a private placement, bringing DKK 972
million into the company and further strengthening our financial position. We
made significant progress in our daratumumab collaboration with Janssen, as we
announced two Phase III studies in our broad and robust development program
and reached a USD 22 million milestone based on progress in an ongoing Phase
II study. In April we were also very pleased that the US regulatory
authorities approved an additional indication for Arzerra in combination with
chlorambucil to treat CLL patients in the first-line setting. We look forward
to further data readouts this year from ongoing Phase III studies with
ofatumumab which could lead to other potential regulatory applications to
expand the label," said Jan van de Winkel, Ph.D., Chief Executive Officer of
Financial Performance First Quarter
*Genmab's revenue increased DKK 87 million or 55% to DKK 247 million in the
first quarter of 2014. The increase was mainly driven by higher revenue
related to our daratumumab collaboration with Janssen.
*Operating expenses were DKK 151 million in the first quarter of 2014,
compared to DKK 131 million in the first quarter of 2013. The increase of
DKK 20 million or 15% was primarily related to an increased investment in
daratumumab and in our other research programs, partly offset by a
decrease in costs associated with the ofatumumab program.
*Operating income was DKK 96 million in the first quarter of 2014 compared
to an operating income of DKK 29 million in the corresponding period for
2013, an improvement of DKK 67 million, which was driven by increased
revenue, partly offset by the increase in operating expenses.
*On March 31, 2014, Genmab had a cash position of DKK 2,530 million. This
represented a net increase of DKK 973 million from the beginning of 2014.
The increase was driven by the net proceeds of DKK 972 million received
from the private placement in January 2014.
Business Progress First Quarter to Present
*May: A Phase III study investigating daratumumab in combination with
bortezomib and dexamethasone versus bortezomib and dexamethasone alone for
the treatment of relapsed or refractory multiple myeloma was announced.
2014 guidance improved due to the inclusion of an anticipated milestone
related to this Phase III study.
*April: The US FDA approved a Supplemental Biologic License Application
(sBLA) for the use of Arzerra (ofatumumab) in combination with
chlorambucil for the treatment of previously untreated patients with CLL
for whom fludarabine-based therapy is considered inappropriate.
*April: GlaxoSmithKline (GSK) reported net sales for Arzerra for the first
quarter of 2014 of GBP 15.6 million, resulting in royalty income of
approximately DKK 28 million to Genmab. The first quarter 2014 net sales
did not include sales related to the supply of ofatumumab for clinical
trials run by other parties. Sales in the first quarter of 2013 were
impacted by clinical trial supply sales.
*March: A USD 22 million (DKK 119 million) milestone payment to Genmab was
triggered by progress in the ongoing Phase II study of daratumumab in
double refractory multiple myeloma under the collaboration with Janssen.
*March: A Phase III study investigating daratumumab in combination with
lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone
for the treatment of relapsed or refractory multiple myeloma was
*January: Raised net proceeds of DKK 972 million following a private
placement of 4.6 million new shares in the company.
*January: Announced a research collaboration with Eli Lilly and Company to
use and evaluate the DuoBody technology platform.
Genmab is maintaining the improved 2014 financial guidance published on May 1,
Genmab will hold a conference call in English to discuss the results for the
first quarter of 2014 today, Wednesday, May 7, at 6.00 pm CEST, 5.00 pm BST or
noon EDT. The dial in numbers are:
+1 866 682 8490 (US participants) and ask for the Genmab conference call
+44 1452 555 131 (international participants) and ask for the Genmab
A live and archived webcast of the call and relevant slides will be available
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing
in the creation and development of differentiated human antibody therapeutics
for the treatment of cancer. Founded in 1999, the company currently has one
marketed antibody, Arzerra(r) (ofatumumab) for the treatment of certain
chronic lymphocytic leukemia indications, a clinical pipeline with both late
and early stage programs, and an innovative pre-clinical pipeline. Genmab's
technology base consists of validated and proprietary next generation antibody
technologies - the DuoBody(r) platform for generation of bispecific
antibodies, and the HexaBody(tm) platform which creates effector function
enhanced antibodies. Genmab's deep antibody expertise is expected to provide a
stream of future product candidates. Partnering of selected innovative
product candidates and technologies is a key focus of Genmab's strategy and
the company 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: firstname.lastname@example.org
This 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
product discovery and development, 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 section "Risk Management" in Genmab's annual report, which is
available on www.genmab.com and the "Significant Risks and Uncertainties"
section in this interim report. Genmab does not undertake any obligation to
update or revise forward looking statements in this interim report 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^(r); the
Y-shaped Genmab logo^(r); Genmab in combination with the Y-shaped Genmab
logo^TM; the DuoBody(tm) logo; the HexaBody(tm) logo; HuMax^(r);
HuMax-CD20^(r); DuoBody^(r), HexaBody^TM and UniBody^(r). Arzerra^(r) is a
registered trademark of the GlaxoSmithKline group of companies.
Company Announcement no. 22
CVR no. 2102 3884
1260 Copenhagen K
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