Genmab Announces Financial Results for the First Quarter of 2014
07 Maggio 2014 - 5:11PM
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 inappropriate
- 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
Genmab.
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 announced.
- 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.
Outlook Genmab is maintaining the improved 2014
financial guidance published on May 1, 2014.
Conference Call 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 conference call A live and archived webcast of
the call and relevant slides will be available at
www.genmab.com.
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.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations
& Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E:
r.gravesen@genmab.com
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 logoTM; the DuoBody(tm) logo; the HexaBody(tm)
logo; HuMax(r); HuMax-CD20(r); DuoBody(r), HexaBodyTM and
UniBody(r). Arzerra(r) is a registered trademark of the
GlaxoSmithKline group of companies.
Company Announcement no. 22 CVR no. 2102 3884
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