Summary: Genmab reports results for the first three months of
2010.
Genmab A/S (Copenhagen:GEN) announced today results
for the three month period ended March 31, 2010. During this
period, Genmab reported the following
results:
Genmab's revenues were DKK 107 million (USD 19 million) for the
first quarter of 2010. In the same period of 2009, Genmab
recognized revenues of DKK 250 million (USD 45
million).
An operating loss of DKK 147 million (USD 27 million). This
compares to an operating loss of DKK 37 million (USD 7
million) for the corresponding period of 2009. The higher operating
loss was mainly related to the decrease in revenues
compared to the first quarter of
2009.
An income of DKK 36 million (USD 7 million) from net financial
items for the first quarter of 2010, compared to a loss of DKK
110 million (USD 20 million) in the same period of 2009. The
financial items, net have continued to be positively impacted
by the improved market conditions which have resulted
in improved fair market valuations of our marketable
securities and foreign exchange rate
adjustments.
A net loss for continuing operations of DKK 116 million (USD 21
million) compared to a net loss of DKK 150 million (USD
27 million) for the same period in 2009. The net loss per
share for continuing operations was DKK 2.57
(USD
0.47) for the first quarter of 2010 compared to DKK 3.34 (USD
0.61) for the first quarter of 2009.
A net loss of DKK 130 million (USD 24 million) compared to DKK
199 million (USD 36 million) in the first quarter of 2009. 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
15 million (USD 3 million) in the first quarter of 2010
compared to DKK 49 million (USD 9 million) in the
first quarter of 2009.
Genmab ended the first quarter with a cash position of DKK 1,077
million (USD 195 million), a decrease of DKK 204 million (USD
37 million) from the end of 2009. The decrease arises
primarily from the investment in our research and development
activities.
Highlights
During the first quarter of 2010, Genmab announced a number of
business and scientific highlights, as follows:
For ofatumumab:
In January, we announced that Arzerra(R) (ofatumumab) received a
positive opinion for conditional approval in Europe for
refractory chronic lymphocytic leukemia
(CLL).
In February, we published net sales of Arzerra for the fourth
quarter of 2009 of approximately DKK 29 million, with an expected
royalty payment to Genmab of DKK 6
million.
For zalutumumab:
In March, we announced top-line results from a zalutumumab Phase
III study in refractory head and neck cancer patients who
failed platinum based chemotherapy. The trial did not meet the
primary endpoint, however patients did experience a
61% increase in progression free survival. The company is
reviewing the results with clinical advisors and regulatory
agencies to determine on how best to proceed with the
product.
For zanolimumab:
In February, we closed a license agreement under which Genmab
granted exclusive worldwide rights to develop and
commercialize zanolimumab (HuMax-CD4(R)) to TenX Biopharma,
Inc.
Declaratory relief complaint:
In March, we announced that Genentech, Inc. and Biogen Idec,
Inc. had filed a declaratory relief complaint at the US
District Court, Southern District of California against
Genmab's collaboration partner GlaxoSmithKline (GSK)
for patent infringement under US patent No 7,682,612 based on
GSK's manufacture, marketing and sale of Arzerra in the US for
the treatment of fludarabine and alemtuzumab refractory
CLL.
Subsequent to the balance sheet
date:
In April, GSK and Genmab announced that the European Commission
had granted a conditional marketing authorization for Arzerra
for the treatment of refractory CLL. The authorization triggered a
milestone payment of approximately DKK 87
million to Genmab.
In April, we announced a new pre-clinical antibody program,
HuMax-cMet™, as well as a novel next generation bispecific antibody
technology.
In April, we published net sales of Arzerra for the first
quarter of 2010 of approximately DKK 42 million, with an
expected royalty payment to Genmab of DKK 8 million.
Outlook
Genmab is maintaining its 2010 financial guidance as announced
on March 2, 2010.
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 cannot 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 US.
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 55 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
http://genmab-facility.com/.
The fair value of the manufacturing facility less costs to sell
is estimated at USD 145 million, approximately DKK 800 million.
Please refer to note 1 of the annual report 2009 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.
In addition to factors already mentioned, the estimates above
are subject to change due to numerous reasons, including
the timing and variation of development activities, related
income and costs and fluctuations in the value of our
marketable securities, fair value less cost to sell related to
our manufacturing facility 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.
Conversion of Certain DKK Amounts to USD
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 March 31, 2010 of USD
1.00 = DKK
5.5232.
Conference Call
Genmab will hold a conference call to discuss the first quarter
results tomorrow, Wednesday, May 12, 2010, 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:
+1 866 224 2914 (in the US) and provide conference ID no.
75100748
+44 (0) 1452 569 103 (outside the US) and provide conference ID
no. 75100748
A live webcast of the call and relevant slides will be available
at 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 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); HuMax-Wnt; HuMax-cMet(TM) and UniBody(R)
are all trademarks of Genmab A/S. Arzerra(R) is a trademark
of GlaxoSmithKline.
CONTACT: Genmab A/S
Helle Husted, Vice President, Investor Relations
+45 33 44 77 30,
M: +45 25 27 47 13
h.husted@genmab.com
