Summary: Genmab reports financial results for the 12 months ended December 31,
2008.
Copenhagen, Denmark; February 24, 2009 - Genmab A/S (OMX: GEN) announced today
results for the financial year ended December 31, 2008.
Revenues of DKK 745 million (USD 141 million) compared to DKK 530 million (USD
100 million) in 2007. The revenues arise primarily from milestone payments,
deferred revenues and services provided under Genmab's collaboration with GSK.
An operating loss of DKK 870 million (USD 165 million). This compares to an
operating loss of DKK 437 million (USD 83 million) reported in 2007. The
increase is primarily attributable to the costs associated with supporting the
increasing level of pre-clinical, clinical and manufacturing activities in
connection with the advancement of our product pipeline of clinical product
candidates through the development process as well as the addition of our new
manufacturing facility.
Net financial items reflected a net loss of DKK 95 million (USD 18 million),
compared to a net income of DKK 54 million (USD 10 million) in the same period
of 2007. The net financial items reflect a combination of interest income and
fair market value adjustments on our portfolio of marketable securities and
unrealized foreign exchange adjustments. The net financial items were negatively
impacted by the continued international financial credit crisis.
A net loss of DKK 965 million (USD 183 million) compared to a net loss in 2007
of DKK 383 million (USD 73 million). The net loss per share was DKK 21.62 (USD
4.09) in 2008 compared to a net loss per share of DKK 8.72 (USD 1.65) in 2007.
Genmab ended the year with a cash position of DKK 1.8 billion (USD 333 million),
which is a decrease of approximately DKK 1.9 billion (USD 366 million) from the
end of 2007. The decrease is primarily due to the DKK 1.2 billion (USD 240
million at the date of completion) acquisition of the manufacturing facility in
March 2008.
USD 1.00 = DKK 5.285 (Danish Central Bank's spot rate on December 31, 2008)
2008 highlights
During 2008 Genmab achieved a number of business and scientific milestones, as
follows:
Clinical Trial Progress
Reported positive Phase III ofatumumab chronic lymphocytic leukemia (CLL) data
Patients in ofatumumab Phase II RA study achieved long lasting responses
Completed recruitment in three ofatumumab studies
Acquisition of US manufacturing facility
Acquired state-of-the-art antibody manufacturing facility in Brooklyn Park,
Minnesota with a capacity of 22,000 liters
Initiated new studies
Initiated 4 new ofatumumab studies
Phase III front line CLL chlorambucil combination
Phase II relapsing remitting multiple sclerosis
Phase I/II subcutaneous RA
Phase I NHL/CLL in Japan
Initiated Phase I/II study of zalutumumab in combination with radiotherapy in
head and neck cancer
Announced five new pre-clinical programs
Partnership milestones
Reached four milestones for payments totaling DKK 378 million in the GSK
collaboration
Portfolio review
Conducted portfolio review resulting in Genmab focusing on oncology indications
and refinement of portfolio to projects with high potential
Subsequent events
Subsequent to the balance sheet date we announced in January and February
submission of a BLA to the US Food and Drug Administration (FDA) and an MAA to
the European Medicines Agency (EMEA) respectively for ofatumumab to treat
patients whose CLL is resistant (refractory) to current therapies.
Outlook
During 2009, we expect to receive our first regulatory approval for ofatumumab
to treat chronic lymphocitic leukemia. We will continue to expand the
development for this product working with our partner, GSK, and sharing
development costs. We also expect to advance other clinical and pre-clinical
programs.
We expect our 2009 revenue to be approximately DKK 1.2 billion (USD 227
million), an increase of DKK 455 million (USD 86 million) over 2008. This
projected revenue consists primarily of milestone payments. We can not be
certain about the outcome or timing of some of the milestone events and
therefore any change in the timing or achievement of the projected milestones
may impact our estimates.
Due to the advancement of our pipeline and the inclusion of the Minnesota
manufacturing facility for the full year in 2009, we anticipate that our
operating expenses will be in line with the 2008 operating expense of DKK 1.6
billion (USD 303 million).
With the projected increase in revenue and stable operating expenses, we expect
the operating loss for 2009 to be approximately DKK 400 million (USD 76
million), less than half of the operating loss of DKK 870 million (USD 165
million) reported for 2008.
As of December 31, 2008 we had cash, cash equivalents and marketable securities
of DKK 1,762 million (USD 333 million). We expect the cash burn for 2009 to be
approximately DKK 500 million (USD 95 million). Therefore we project a cash
balance at the end of the year of approximately DKK 1,250 million (USD 237
million).
The estimates above are subject to change due to numerous factors, including the
timing and variation of development activities, related income and costs and
fluctuations in the value of our marketable securities and currency exchange
rates. The financial guidance also assumes that no further significant
agreements are entered into during 2009 that could materially affect the
results.
For the convenience of the reader certain DKK amounts have been converted to
USD. The conversion has been made using the Danish Central Bank closing spot
rate on December 31, 2008 of USD 1.00 = DKK 5.285.
Conference Call
Genmab's management will hold a conference call to discuss the 2008 financial
results, tomorrow, Wednesday February 25, 2009 at:
3:00 pm CET
2:00 pm GMT
9:00 am EST
The dial in numbers are as follows:
+1 877-879-6209 (in the US) and ask for the Genmab conference call
+1 719-325-4754 (outside the US) and ask for the Genmab conference call
To listen to a live webcast of the call please visit www.genmab.com.
The financial statements release for 2008 and slides relevant for the conference
call can be found on Genmab's website www.genmab.com. The conference call will
be held in English.
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 www.genmab.com.
This Stock Exchange 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 Financial Statements Release, which is available
on www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange 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-CD20(R); HuMax-EGFr(TM);
HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM);
HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM) and UniBody(R) are all trademarks
of Genmab A/S. Arzerra(TM) is a trademark of GlaxoSmithKline.
Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com
Stock Exchange Release no. 06/2009
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