COPENHAGEN, Denmark, Oct. 29 /CNW/ -
- Summary: Genmab Reports Results for the Nine Month Period Ended
September 30, 2008
Genmab A/S (OMX: GEN) announced today results for the nine month period
ended September 30, 2008. During this period, Genmab reported the following
- Genmab's revenues were DKK 667 million (USD 128 million) for the nine
month period ended September 30, 2008. In the same period of 2007,
Genmab recognized revenues of DKK 356 million (USD 68 million).
- An operating loss of DKK 508 million (USD 97 million). This compares
to an operating loss of DKK 309 million (USD 59 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 nine month period ended September 30,
2008 reflected a net loss of DKK 18 million (USD 4 million), compared
to a net income of DKK 48 million (USD 9 million) in the same period
of 2007. The net financial income reflects a combination of interest
income and fair market value adjustments on our portfolio of
marketable securities and unrealized foreign exchange adjustments.
Our net financial income was negatively impacted by the continued
international financial credit crisis.
- A net loss of DKK 526 million (USD 101 million) compared to a net
loss of DKK 261 million (USD 50 million) for the same period in 2007.
The net loss per share was DKK 11.81 (USD 2.26) for the first nine
months of 2008 compared to DKK 5.97 (USD 1.14) in the first nine
months of 2007.
- Genmab ended the nine month period with cash and marketable
securities of DKK 2.1 billion (USD 402 million), which is a decrease
of DKK 1.6 billion (USD 306 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.
During the third quarter of 2008, Genmab achieved a number of business and
scientific milestones, as follows:
- We announced 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 milestone under the
GlaxoSmithKline (GSK) collaboration agreement.
- We completed recruitment in a second pivotal ofatumumab study in
refractory non-Hodgkin's Lymphoma (NHL) patients and in two Phase II
studies. Data from all three are expected in 2009.
- We announced plans to begin four studies with ofatumumab this year:
1) Phase III CLL front line chlorambucil combination study.
2) Phase II CLL ofatumumab retreatment and maintenance treatment study
for patients who have participated in the ongoing Phase III CLL
3) Phase II NHL ofatumumab retreatment and maintenance study for
patients who have participated in the ongoing Phase III NHL study.
4) Phase I study in Japan. In September we received a milestone payment
of DKK 29 million for this study.
Subsequent to the balance sheet date:
- We announced the outcome of a portfolio and organizational review. We
conducted this review in order to bring greater focus to creating the
most potential value for patients and shareholders and to build a
sustainable business. As a result of the review, we plan to
concentrate on development of cancer therapeutics and will focus on a
less broad, but higher potential portfolio. Consequently, key
decisions from the review include discontinuing the zanolimumab
program, moving to out-license three pre-clinical programs and
reducing head count by approximately 100 employees, or 15%.
- We announced data showing that rheumatoid arthritis patients who
participated in the ofatumumab Phase II study achieved long lasting
results at the 48 week follow up period.
Genmab is maintaining its 2008 financial guidance with a net loss in the
range of DKK 800 to 900 million and projects that the operating loss will be
at the lower end of the prior guidance of DKK 850 to 950 million.
The revenue is also anticipated to be at, or slightly below, the range
indicated in the prior guidance of DKK 850 to 900 million due to a slight
change in the timing of some anticipated milestone events. However, savings
driven by reductions in our research and development costs resulting from our
efforts to focus on the most critical programs in our portfolio in the most
efficient manner, more than offset the change in revenue and lower net
We expect that the net financial income will be lower than the previous
guided income of DKK 40 to 50 million due to the impact of the turbulent
credit markets on the fair market values of our marketable securities.
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, unchanged from previous guidance.
Pre-clinical Program Overview
During tomorrow's conference call, Genmab will provide an overview of
some of its pre-clinical programs. Genmab is working very actively on multiple
pre-clinical cancer programs including antibodies directed to the clinically
validated targets Her-2 and VEGF as well as antibodies to two novel targets,
Tissue Factor and a target expressed on cancer stem cells.
Genmab will hold a conference call to discuss the results for the first
nine months of 2008 tomorrow, Thursday, October 30, 2008, at
2:00 pm CET
1:00 pm GMT
9:00 am EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1-800-304-7079 (in the US) and ask for the Genmab conference call
+1-706-634-5694 (outside the US) and ask for the Genmab conference call
Please provide the following conference ID number: 69561922.
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.
Selected Consolidated Key Figures
2008 2007 2008 2007
DKK'000 DKK'000 USD'000 USD'000
Revenues 667,496 356,062 127,959 68,257
development costs (1,020,774) (582,045) (195,682) (111,578)
expenses (110,265) (82,973) (21,138) (15,906)
Operating loss (508,057) (308,956) (97,394) (59,227)
Net loss (526,474) (261,226) (100,925) (50,077)
Cash and marketable
securities 2,095,389 3,921,296 401,685 751,710
Non-current assets 1,284,660 32,874 246,269 6,303
Assets 3,641,566 4,092,670 698,086 784,564
Shareholders' equity 2,546,762 2,972,654 488,213 569,856
Share capital 44,735 44,506 8,576 8,532
Cash flow from
operating activities (288,652) 692,865 (55,334) 132,821
Cash flow from
investing activities 349,576 (2,530,227) 67,015 (485,043)
Cash flow from
financing activities 13,334 1,560,631 2,556 299,172
Basic and diluted net
loss per share (11.81) (5.97) (2.26) (1.14)
market price 300.00 325.00 57.51 62.30
Price/book value 5.27 4.87 5.27 4.87
per share 56.93 66.79 10.91 12.80
Equity ratio 70% 73% 70% 73%
Average number of
employees 535 288 535 288
Number of employees at
the end of the period 643 335 643 335
About Genmab A/S
Genmab is a leading international biotechnology company focused on
developing fully human antibody therapeutics for the potential treatment of
cancer. Genmab's world class discovery, development and manufacturing teams
are using cutting-edge technology to create and develop products to address
unmet medical needs. Our primary goal is to improve 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
For further information:
For further information: Helle Husted, Sr. Director, Investor Relations,
T: +45-33-44-77-30, M: +45-25-27-47-13, E: firstname.lastname@example.org