Genmab Announces Financial Results for the First Half of 2013 and Improves
2013 Financial Guidance
COPENHAGEN, Denmark, Aug. 14, 2013 (GLOBE NEWSWIRE) --
Interim Report First Half 2013
*Reported positive top line results in Phase III study of ofatumumab in
previously untreated chronic lymphocytic leukemia (CLL)
*Received Breakthrough Therapy Designation for daratumumab
*First half net sales of Arzerra(r) increased 40% over prior year
*Improved operating result by DKK 93 million over H1 2012
*Improved guidance and year-end cash balance
"The strength and value of our pipeline is becoming very clear as we achieve
our goals with ofatumumab and daratumumab. We reported two strong sets of data
on ofatumumab in chronic lymphocytic leukemia during the second quarter which
show the future promise of this therapy. We were also very pleased that
daratumumab was awarded Breakthrough Therapy Designation by the FDA, which we
hope will expedite bringing this treatment to the market. These achievements,
together with our improved financial guidance, continue to move Genmab forward
to our goal of becoming sustainably profitable," said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half
*Genmab's revenue was DKK 298 million for the first half of 2013 compared
to DKK 206 million for the corresponding period in 2012. The increase of
DKK 92 million or 45% was mainly driven by revenue related to our
daratumumab collaboration with Janssen Biotech (Janssen) as well as higher
*Operating expenses were unchanged at DKK 287 million compared to the first
half of 2012.
*Operating income was DKK 11 million in the first half of 2013 compared to
an operating loss of DKK 82 million in the corresponding period for 2012,
an improvement of DKK 93 million. The improved operating result was driven
by increased revenue and continued strong focus on cost control.
*The net result for discontinued operation amounted to a net income of DKK
42 million in the first half of 2013. The net income in 2013 related to
the final few months of running costs of the Minnesota manufacturing
facility of DKK 10 million prior to its divestiture and a gain on the sale
of DKK 52 million. The facility maintenance cost amounted to DKK 20
million in the first half of 2012.
*On June 30, 2013, Genmab had a cash position of DKK 1,547 million. This
represented a net increase of DKK 31 million from the beginning of 2013
which was primarily related to proceeds from the sale of the manufacturing
facility and proceeds from the exercise of warrants in the first half of
2013, partially offset by the ongoing investment in our research and
development activities. The cash burn for the first half of 2012 was DKK
Business Progress Second Quarter to Present
*April & May: The US Food and Drug Administration (FDA) granted
Breakthrough Therapy, Fast Track and Orphan Drug Designations for
daratumumab. The designations cover patients with multiple myeloma who
have received at least three prior lines of therapy including a proteasome
inhibitor (PI) and an immunomodulatory agent (IMiD) or are double
refractory to a PI and an IMiD.
*April: The US Court of Appeals for the Federal Circuit upheld the US
District Court's judgment in favor of GSK in a patent infringement case
involving Arzerra brought against GSK by Genentech and Biogen Idec. A
request for a re-hearing was filed by Genentech and Biogen Idec in May and
subsequently refused by the US Court of Appeals in July.
*May: Reported positive top line data from a Phase II study of ofatumumab
in combination with bendamustine in patients with untreated or relapsed
CLL. The overall response rate (ORR) in the study was 95% in previously
untreated patients and 74% in patients with relapsed CLL.
*May: Reported positive top line results from a Phase III study of
ofatumumab in combination with chlorambucil versus chlorambucil alone in
patients with previously untreated CLL. A 9.3 month improvement in median
progression free survival (PFS) was seen in patients who received
ofatumumab and chlorambucil compared to patients who received chlorambucil
*May: Launched Sponsored Level 1 American Depositary Receipt (ADR Program)
under the ticker symbol GMXAY.
*June: Phase II development of teprotumumab (RG1507, an antibody created by
Genmab in collaboration with Roche) in active thyroid eye disease was
restarted by River Vision Development Corporation, who licensed the
product from Roche.
*July: A Phase III study of ofatumumab given subcutaneously to treat
pemphigus vulgaris (PV), a rare autoimmune disorder of the skin, is being
started by GSK.
*July: Filed an Investigational New Drug application (IND) with the US FDA
for HuMax(r)-TF-ADC in solid tumors.
*July: GSK reported net sales for Arzerra for the second quarter of 2013 of
GBP 17.8 million, an increase of 19% over Q2 2012, resulting in royalty
income of DKK 31 million to Genmab.
Genmab is improving its 2013 financial guidance as announced on March 7,
Genmab will hold a conference call in English to discuss the results for the
first half of 2013 today, Wednesday, August 14, 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
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
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; HuMax^(r); HuMax-CD20^(r); DuoBody^(r),
HexaBody^TM and UniBody^(r). Arzerra^(r) is a registered trademark of
Company Announcement no. 34
CVR no. 2102 3884
1260 Copenhagen K
Press spacebar to pause and continue. Press esc to stop.