Summary: Genmab reports financial results for the 12 months ended
December 31, 2009.
Genmab A/S (Copenhagen:GEN) announced today results for the
financial year ended December 31, 2009.
Revenues of DKK 586 million (USD 113 million) compared to DKK
692 million (USD 133 million) in 2008. The revenues arise primarily
from the recognition of milestone payments, deferred revenue, and
services provided under Genmab's development collaboration
agreement with GSK. For 2009, revenues also include royalty income
of DKK 6 million, based on Arzerra sales of DKK 29 million.
An operating loss of DKK 498 million (USD 96 million). This
compares to an operating loss of DKK 722 million (USD 139 million)
reported in 2008. The savings are driven by our continued strong
focus on cost savings and control.
Net financial items reflected a net income of DKK 156 million
(USD 30 million), compared to a net loss of DKK 95 million (USD 18
million) in 2008. The net financial items reflect a combination of
interest income and unrealized and realized fair market value
adjustments on our portfolio of marketable securities and realized
and unrealized foreign exchange adjustments.
A net loss for continuing operations of DKK 348 million (USD 67
million)compared to a net loss in 2008 of DKK 817 million (USD 158
million). The net loss per share continuing operations was DKK 7.75
(USD 1.49) in 2009 compared to a net loss per share continuing
operations of DKK 18.31 (USD 3.53) in 2008.
A net loss of DKK 1,011 million (USD 195 million) compared to
DKK 965 million (USD 186 million) in 2008. This includes the
results of our manufacturing facility, which has been classified as
held for sale and presented as a discontinued operation due to our
decision to sell the facility. The loss for discontinued operation
amounted to DKK 662 million (USD 128 million) in 2009 including an
impairment of DKK 419 million (USD 81 million) compared to DKK 148
million (USD 28 million) in 2008.
Genmab ended the year with a cash position of DKK 1.3 billion
(USD 247 million), which is a decrease of DKK 481 million (USD 93
million) from the end of 2008. The decrease is primarily related to
the investment in our research and development activities.
USD 1.00 = DKK 5.1901 (Danish Central Bank's spot rate on
December 31, 2009)
2009 highlights
During 2009, Genmab achieved a number of business and scientific
milestones, as follows:
Arzerra (ofatumumab) Approved by FDA
Filed Biologics License Application (BLA) with the FDA for
ofatumumab in refractory chronic lymphocytic leukemia (CLL), in
collaboration with GlaxoSmithKline (GSK)
Received accelerated approval for ofatumumab from the FDA for
CLL that is refractory to fludarabine and alemtuzumab
Submitted Marketing Authorization Application (MAA) to the EMA
and subsequently received a CHMP positive opinion recommending the
granting of a conditional marketing authorization for ofatumumab
for the treatment of CLL in patients who are refractory to
fludarabine and alemtuzumab
Collaboration Milestones
Reached three milestones for payments totaling DKK 261 million
in the GSK collaboration
Received one-time payment of USD 4.5 million from GSK in
exchange for terminating ofatumumab co-promotion option
Clinical Trial Progress
Published results from four ofatumumab studies
Phase III study in rheumatoid arthritis (RA)
Phase II front line combination study in CLL
Phase II front line combination study in non-Hodgkin's lymphoma
(NHL)
Pivotal Phase III study in rituximab refractory NHL
Initiated Phase III study of ofatumumab with chemotherapy versus
rituximab with chemotherapy in relapsed or refractory DLBCL
Completed enrolment in one zalutumumab study and two ofatumumab
studies
Reorganization
Announced plan to match resources to ongoing and future needs,
sell manufacturing facility and reduce headcount by approximately
300 positions. The majority of the reductions were completed by the
end of the year; the remaining reductions will be completed during
2010 once tasks have been transferred.
Subsequent events
Subsequent to the balance sheet date we announced that the CHMP
issued a positive opinion for ofatumumab for the treatment of
patients with CLL who are refractory to fludarabine and
alemtuzumab.
Further, in February, we announced that we had closed a license
agreement under which we granted exclusive worldwide rights to
develop and commercialize zanolimumab (HuMax-CD4(R)) to TenX
Biopharma, Inc.
In February, we also announced net sales of Arzerra in the U.S.
for the fourth quarter of 2009 of approximately DKK 29 million
(approximately USD 5.5 million) resulting in royalty income of DKK
6 million.
Outlook
We expect our 2010 revenue, exclusive of royalties from Arzerra
sales, to be approximately DKK 350 - 450 million, compared to DKK
586 million reported for 2009. This projected revenue consists
primarily of deferred revenue and 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.
Royalty income from Arzerra sales has not been included in the
guidance above as it is difficult to estimate product revenues
given the short period that the product has been on the market in
the U.S.
We anticipate that our 2010 operating expenses from continuing
operations will be slightly lower than 2009 at approximately DKK
950 - 1,050 million, reflecting the advancement of our clinical and
pre-clinical programs offset by the implementation of the
reorganization plan that was announced in November 2009. The
reorganization plan included a headcount reduction of 300 positions
and the intent to sell our manufacturing facility in Minnesota.
We expect the operating loss from continuing operations for 2010
to be approximately DKK 550 - 650 million, compared to the
operating loss of DKK 498 million reported for 2009.
The discontinued operation guidance of DKK 50 million relates to
the ongoing running costs of the Minnesota manufacturing facility
and represents a full 12 months of activity maintaining the
facility in a validated state. This cost could be lower if the
facility is sold before the end of the year. We have launched an
active sales process and further details of the facility can be
viewed at www.genmab-facility.com.
The fair value of the manufacturing facility less costs to sell
is estimated at USD 145 million, approximately DKK 750 million.
Please refer to note 1 of the financial statements for further
details.
As of December 31, 2009 we had cash, cash equivalents and
marketable securities of DKK 1,281 million. Therefore we project a
cash balance at the end of the year of approximately DKK 1,050 -
1,200 million.
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2010 Guidance
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DKK USD
Millions Millions
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Revenue* 350 - 450 67 - 87
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Operating expenses (950) - (1,050) (183) - (202)
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Operating loss continuing (550) - (650) (106) - (125)
operations
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Discontinued operation (50) (10)
Facility sale 750 145
Cash at beginning of year** 1,281 247
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Cash at the end of year** 1,050 - 1,200 202 - 231
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* Not including Arzerra royalties
** Cash, cash equivalents, and marketable securities
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The estimates above are subject to change due to numerous
factors, including the timing of the sale and consideration
received for the manufacturing facility, 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 2010 that could materially
affect the results, and as such does not include any licensing
revenue or other cash inflows relating to zalutumumab.
Conversion of our 2010 guidance has been made using the Danish
Central Bank closing spot rate on December 31, 2009, of USD 1.00 =
DKK 5.1901.
Conference Call
Genmab's management will hold a conference call to discuss the
2009 financial results, tomorrow, Wednesday, March 3, 2010 at:
3:00 pm CET
2:00 pm GMT
9:00 am EST
The conference call will be held in English.
The dial in numbers are as follows:
+1 877-941-0843 (in the U.S.) and provide conference ID number
4244382
+1 480-629-9643 (outside the U.S.) and provide conference ID
number 4244382
To listen to a live webcast of the call please visit
www.genmab.com.
The financial statements release for 2009 and slides relevant
for the conference call can be found on Genmab's website
www.genmab.com.
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 and development
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 Annual Report, 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.
Stock Exchange Release no. 06/2010
CONTACT: Genmab A/S
Helle Husted, Vice President, Investor Relations
+45 33 44 77 30
Mobile: +45 25 27 47 13
h.husted@genmab.com