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Genmab — Earnings Release 2010
May 11, 2010
3365_rns_2010-05-11_2e1745bc-1fc4-43cf-8040-46a421711c79.html
Earnings Release
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News Details
Ad-hoc | 11 May 2010 17:37
Genmab Announces 2010 First Quarter Results
Genmab A/S /
11.05.2010 17:37
Dissemination of a Adhoc News, transmitted by
DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
Summary: Genmab reports results for the first three months of 2010.
Copenhagen, Denmark; May 11, 2010 - Genmab A/S (OMX: 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
approxi-mately 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: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: [email protected]
Stock Exchange Release no. 18/2010
News Source: NASDAQ OMX
11.05.2010 Ad hoc announcement, Financial News and Media Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
Language: English
Company: Genmab A/S
Denmark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
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