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Genmab — Earnings Release 2009
Mar 2, 2010
3365_rns_2010-03-02_d2087ee1-0270-4842-896f-49c489b51f6a.html
Earnings Release
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News Details
Ad-hoc | 2 March 2010 18:54
Genmab Announces Year End 2009 Financial Results
Genmab A/S /
02.03.2010 18:54
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 financial results for the 12 months ended December 31,
2009.
Copenhagen, Denmark; March 2, 2010 - Genmab A/S (OMX: 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 US 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 have 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 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.
| 2010 Guidance | |
| | DKK | USD |
| | Millions | Millions |
| Revenue* | 350 - 450 | 67 - 87 |
| Operating expenses | (950) - (1,050) | (183) - (202) |
| Operating loss continuing | (550) - (650) | (106) - (125) |
| operations | | |
| Discontinued operation | (50) | (10) |
| Facility sale | 750 | 145 |
| Cash at beginning of year** | 1,281 | 247 |
| Cash at the end of year** | 1,050 - 1,200 | 202 - 231 |
| * Not including Arzerra royalties |
| ** Cash, cash equivalents, and marketable securities |
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 US) and provide conference ID number 4244382
+1 480-629-9643 (outside the US) 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.
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. 06/2010
News Source: NASDAQ OMX
02.03.2010 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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