Genmab Announces 2008 First Half Year Results

Summary: Genmab Reports Results for the Six Month Period Ended June 30, 2008

COPENHAGEN, August 27 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN)
announced today results for the six month period ended June 30, 2008. During
this period, Genmab reported the following results:
Genmab's revenues were DKK 277 million (USD 59 million) for the first
half of 2008. In the same period of 2007, Genmab recognized revenues of DKK
280 million (USD 59 million).
An operating loss of DKK 471 million (USD 100 million). This compares to
an operating loss of DKK 119 million (USD 25 million) reported for the
corresponding period of 2007. The larger operating loss was driven by the
increased level of pre-clinical and clinical activities associated with the
advancement of our product pipeline.
Net financial income for the first half of 2008 reflected a net loss of
DKK 20 million (USD 4 million), compared to a net income of DKK 32 million
(USD 7 million) in the same period of 2007. The net financial income reflects
a combination of interest income and fair market value adjustments from our
portfolios of marketable securities and unrealized foreign exchange losses
derived from the continued weakening of the USD against the DKK in the first
half of 2008.
A net loss of DKK 491 million (USD 104 million) compared to a net loss of
DKK 87 million (USD 18 million) for the same period in 2007. The net loss per
share was DKK 11.02(USD 2.33) for the first half of 2008 compared to DKK
2.01(USD 0.42) in the first half of 2007.
Genmab ended the six month period with cash and marketable securities of
DKK 2.1 billion (USD 443 million), which is a decrease of DKK 1.6 billion
(USD 338 million) from the end of 2007. The decrease primarily arises from
the DKK 1.2 billion (USD 240 million at the date of acquisition) acquisition
of the manufacturing facility in March 2008.
Highlights
During the second quarter of 2008, Genmab achieved a number of business
and scientific milestones, as follows:
We achieved a development milestone for ofatumumab (HuMax-CD20(R)) under
the collaboration with GlaxoSmithKline (GSK). A milestone payment of DKK 29
million (USD 6 million) was triggered by the first patient participating in
the Phase II study for the treatment of relapsing remitting multiple
sclerosis (RRMS).
We announced a Phase I/II study to evaluate a subcutaneous route of
administration of ofatumumab (HuMax-CD20(R)) in rheumatoid arthritis (RA).
We appointed David Eatwell as new Chief Financial Officer.
We initiated two Phase I/II studies of zalutumumab (HuMax-EGFr(TM)), one
to treat colorectal cancer (CRC) and another study in combination with
radiotherapy for the treatment of advanced head and neck cancer.
Subsequent to the balance sheet date:
We announced the positive top-line results from a Phase III pivotal study
evaluating ofatumumab (HuMax-CD20(R)) in two groups of patients with chronic
lymphocytic leukaemia (CLL). The study met the primary endpoint in both
patient populations and the results from the secondary endpoints also
supported the primary endpoint. This event also marked the achievement of a
DKK 233 million (USD 49 million) milestone under the GSK collaboration
agreement.
We announced plans to begin four studies of ofatumumab in CLL and NHL
this year, including;
1) Phase III CLL front line chlorambucil combination study. This
open-label, parallel-arm study will include 444 patients with previously
untreated CLL.
2) Phase II CLL ofatumumab retreatment and maintenance treatment study.
This study will examine the retreatment and maintenance treatment of
refractory CLL patients who participated in the ongoing Phase III CLL study.
3) Phase II NHL ofatumumab retreatment and maintenance study. This study
will examine the retreatment and maintenance treatment of refractory
follicular NHL patients who participated in the ongoing Phase III NHL study.
4) Phase I study in Japan. The primary objective of the study is to
evaluate the safety and tolerability of ofatumumab in Japanese
relapsed/refractory follicular NHL and CLL patients.
We completed recruitment of 56 patients in the Phase II study of
ofatumumab in combination with fludarabine and cyclophosphamide to treat CLL
in previously untreated patients.
Amgen informed Genmab that it would discontinue development for AMG714 in
psoriasis and RA based on disappointing results from recent clinical studies.
Amgen is exploring options to maximize the value of this asset, but at this
time no further internal development of a lead indication is planned.
Outlook
Genmab is maintaining its financial guidance for the net loss in 2008 in
the range of DKK 800 to 900 million and projects a slightly improved
operating loss of DKK 850 to 950 million compared to previous guidance of DKK
900 to 1,000 million. This is despite a lower revenue estimate, which is now
anticipated to be in the range of DKK 850 to 900 million due to a slight
change in the timing of some anticipated milestone events and lower net
financial income which is now expected to be DKK 40 to 50 million. The
savings are driven by a reduction in our research and development costs which
is a result of our efforts to focus on the most critical programs in our
portfolio in the most efficient manner. We therefore currently anticipate
that we will start fewer new studies in 2008 than the 17 previously planned.
As of December 31, 2007, Genmab had cash, cash equivalents and short-term
marketable securities of DKK 3.7 billion. For 2008, we project that our
operations together with the DKK 1.2 billion acquisition of the manufacturing
facility in Minnesota will lead to a year end cash position of DKK 1.7 to 1.8
billion (USD 359 million to USD 380 million), unchanged from previous
guidance. The proportion of the budget spent on research and development, and
on the ofatumumab program, also remain approximately the same as previous
guidance.
Conference Call
Genmab will hold a conference call to discuss the 2008 first half year
results tomorrow, Thursday, August 28, 2008, at
3.00 pm CEST
2.00 pm BST
9.00 am EDT

The conference call will be held in English.

The dial in numbers are as follows:

+1-877-795-3648 (in the US) and ask for the Genmab conference call
+1-719-325-4750 (outside the US) and ask for the Genmab conference call

A live webcast of the call and relevant slides will be available at
http://www.genmab.com. The webcast will also be archived on Genmab's website.
About Genmab A/S
Genmab is a leading international biotechnology company focused on
developing fully human antibody therapeutics for unmet medical needs. Using
cutting-edge antibody technology, Genmab's world class discovery, development
and manufacturing teams have created and developed an extensive pipeline of
products for potential treatment of a variety of diseases including cancer
and autoimmune disorders. As Genmab advances towards a commercial future, we
remain committed to our primary goal of improving the lives of patients who
are in urgent need of new treatment options. For more information on Genmab's
products and technology, visit http://www.genmab.com.
This press release 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
http://www.genmab.com. Genmab does not undertake any obligation to update or
revise forward looking statements in this press release nor to confirm such
statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R);
HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM);
HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab
A/S.
Stock Exchange Release no. 38/2008
Contact: Helle Husted, Sr. Director, Investor Relations, T:
+45-33-44-77-30, M: +45-25-27-47-13, E: hth@genmab.com
SOURCE Genmab A/S

Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30,
M: +45-25-27-47-13, E: hth@genmab.com