Ad-hoc | 12 May 2009 17:35
Genmab A/S /
Release of a Adhoc News, transmitted by DGAP - a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
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Summary: Genmab reports results for the first three months of 2009.
Copenhagen, Denmark; May 12, 2009 - Genmab A/S (OMX: GEN) announced today
results for the three month period ended March 31, 2009. During this period,
Genmab reported the following results:
Revenues of DKK 252 million (USD 45 million) for the first quarter of 2009. In
the same period of 2008, Genmab recognized revenues of DKK 167 million (USD 30
million).
An operating loss of DKK 86 million (USD 15 million). This compares to an
operating loss of DKK 197 million (USD 35 million) for the corresponding period
of 2008. The improvement is mainly related to increased revenues compared to the
corresponding period in 2008, as well as a strong focus on cost control.
A net financial items net loss for the first quarter of 2009 of DKK 110 million
(USD 20 million) compared to a net loss of DKK 14 million (USD 2 million) in the
same period of 2008. The net financial items reflect a combination of interest
income, fair market value adjustments on our portfolio of marketable securities
and foreign exchange adjustments. In 2009, the net financial items were
negatively impacted by the continued international financial credit crisis.
Given the current market conditions all new cash inflows are invested in highly
liquid and conservative investments, such as government obligations.
A net loss of DKK 199 million (USD 36 million) compared to a net loss of DKK 210
million (USD 38 million) for the same period in 2008. The net loss per share was
DKK 4.44 (USD 0.79) for the first quarter of 2009 compared to DKK 4.73 (USD
0.84) in the first quarter of 2008.
Genmab ended the first quarter with a cash position of DKK 1,429 million (USD
255 million), a decrease of DKK 333 million (USD 60 million) from the end of
2008. The decrease arises primarily from the cash burn on our research and
development activities and reduced market values of some of our marketable
securities.
Highlights
During the first quarter of 2009, Genmab announced a number of business and
scientific highlights, as follows:
For ofatumumab in refractory chronic lymphocytic leukemia (CLL):
- Biologics License Application (BLA) filed with the US FDA in collaboration
with GlaxoSmithKline (GSK) on January 30
- BLA filing accepted and granted priority review status on March 30, triggering
a milestone payment from GSK to Genmab of DKK 87 million (approximately USD 16
million)
- As a result of the BLA acceptance, Genmab received a one-time payment of USD
4.5 million from GSK for terminating its option to co-promote ofatumumab
- FDA granted ofatumumab an orphan drug designation in CLL
- Marketing Authorization Application (MAA) submitted to the European Medicines
Agency, together with GSK, on February 5. On February 25, the MAA was deemed
valid, resulting in a milestone payment from GSK to Genmab of DKK 58 million
(approximately USD 10 million)
For zalutumumab:
- Interim survival analysis of the Phase III pivotal study in refractory head
and neck cancer patients did not fulfill a criterion for early stopping after
half of the trial had been completed. However, an independent data monitoring
committee (IDMC) evaluated the interim results and concluded that the
benefit-risk profile was acceptable and that the trial should continue.
Subsequent to the balance sheet date:
- We announced on May 4 that the FDA's Oncologic Drugs Advisory Committee will
hold a meeting to review the Arzerra BLA for the treatment of patients with CLL
on May 29.
- On May 11 we announced that data from the ofatumumab and R1507 development
programs will be presented at the 2009 ASCO Annual Meeting.
Outlook
Genmab is maintaining its 2009 financial guidance. We expect our 2009 revenue to
be approximately DKK 1.2 billion. 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.
We anticipate that our operating expenses will be in line with the 2008
operating expense of DKK 1.6 billion.
With the projected increase in revenue and stable operating expenses, we expect
the operating loss for 2009 to be approximately DKK 400 million.
As of December 31, 2008 we had cash, cash equivalents and marketable securities
of DKK 1,762 million. We expect the cash burn for 2009 to be approximately DKK
500 million. Therefore we project a cash balance at the end of the year of
approximately DKK 1,250 million.
2009 Guidance DKK USD
Millions Millions
Revenue 1,200 214
Operating expenses 1,600 285
Operating loss (400) (71)
Cash burn (500) (89)
Cash at end of year* 1,250 223
*Cash, cash equivalents and marketable securities.
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.
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, 2009 of USD 1.00 = DKK 5.5968.
Conference Call
Genmab will hold a conference call to discuss the first quarter results
tomorrow, Wednesday, May 13, 2009, 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:
+1 877-857-6147 (in the US) and ask for the Genmab conference call
+1 719-325-4773 (outside the US) and ask for the Genmab conference call
To listen to a live webcast of the call please visit www.genmab.com.
Relevant slides for the call can be found on www.genmab.com prior to the call.
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 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: h.husted@genmab.com
Stock Exchange Release no. 17/2009
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News Source: NASDAQ OMX
12.05.2009 Financial News transmitted by DGAP
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Language: English
Issuer: Genmab A/S
Denmark
Phone:
Fax:
E-mail:
Internet:
ISIN: DK0010272202
WKN:
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