Summary: Genmab reports results for the six month period ended June 30, 2009
Copenhagen, Denmark; August 18, 2009 - Genmab A/S (OMX: GEN) announced today
results for the six month period ended June 30, 2009. During this period, Genmab
reported the following results:
- Genmab's revenues were DKK 348 million (USD 66 million) for the first half of
2009. In the same period of 2008, Genmab recognized revenues of DKK 277 million
(USD 53 million).
- An operating loss of DKK 326 million (USD 62 million). This compares to an
operating loss of DKK 471 million (USD 89 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 savings and
control.
- An income of DKK 18 million (USD 3 million) from net financial items for the
first half of 2009, compared to a loss of DKK 20 million (USD 4 million) in the
same period of 2008. During 2009, the net financial items experienced
significant volatility with the second quarter income of DKK 128 million (USD 24
million) fully reversing the loss of DKK 110 million (USD 21 million) recorded
in the first quarter of 2009.
- A net loss of DKK 314 million (USD 60 million) compared to a net loss of DKK
491million (USD 93 million) for the same period in 2008. The net loss per share
was DKK 6.98 (USD 1.33) for the first half of 2009 compared to DKK 11.02 (USD
2.09)
in the first half of 2008.
- Genmab ended the six month period with a cash position of DKK 1,474 million
(USD 280 million), a decrease of DKK 288 million (USD 55 million) from the end
of 2008. The decrease arises primarily from the investment in our research and
development activities.
Highlights
During the second quarter of 2009, Genmab announced a number of business and
scientific highlights, as follows:
For ofatumumab in refractory chronic lymphocytic leukemia (CLL):
- The US FDA's ODAC voted 10 to 3 that the ofatumumab data submitted in the BLA
are reasonably likely to predict clinical benefit for patients with CLL whose
disease is refractory to fludarabine and alemtuzumab
- The FDA extended the action date for the ofatumumab BLA by three months to
October 31, 2009 to allow the agency to review additional data
ASCO:
- Data from the Arzerra(TM) (ofatumumab) and R1507 development programs was
presented at the 2009 ASCO Annual Meeting
For zalutumumab:
- The FDA placed a partial clinical hold on zalutumumab clinical studies being
conducted under the US IND application, as well as requests for new studies. The
company met the FDA's request for additional safety information and the hold was
lifted on July 16
- Enrolment of 273 patients in the zalutumumab pivotal Phase III study in
refractory head and neck cancer was completed in June
Subsequent to the balance sheet date:
- In July, we announced completion of patient recruitment in two ofatumumab
studies: the Phase III pivotal study in refractory CLL and the Phase II study in
relapsed DLBCL
- In July and August, we published top-line results from three ofatumumab
studies: a Phase III study to treat RA in patients refractory to methotrexate;
a Phase II front line combination study in CLL; and a pivotal Phase III study
in rituximab refractory follicular NHL
- In August, we published revised financial guidance for 2009 to reflect the
exclusion of a milestone related to the Phase III NHL study, as the top-line
results were not strong enough to trigger the related milestone payment from
GlaxoSmithKline
Outlook
As announced on August 17, 2009, Genmab revised its 2009 financial guidance. We
now expect our 2009 revenue to be approximately DKK 750 million compared to the
previous estimate of DKK 1.2 billion. The reduction in revenue is primarily due
to the exclusion of a milestone payment under the Arzerra™ (ofatumumab)
collaboration with GlaxoSmithKline.
With a continued focus on cost control we now anticipate that our operating
expenses will be approximately DKK 1.4 billion, DKK 200 million below our
previous guidance of DKK 1.6 billion. This will result in a revised operating
loss of approximately DKK 650 million, as compared to our previous guidance of
DKK 400 million.
We now expect the cash burn for 2009 to be approximately DKK 700 million
compared to previous guidance of DKK 500 million. Therefore we project a cash
balance at the end of the year of approximately DKK 1,050 million, DKK 200
million below our previous guidance.
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| 2009 Guidance | New | | Previous |
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| | DKK | USD | | DKK | USD |
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| | Millions | Millions | | Millions | Millions |
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| Revenue | 750 | 142 | | 1,200 | 228 |
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| Operating expenses | 1,400 | 265 | | 1,600 | 304 |
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| Operating loss | (650) | (123) | | (400) | (76) |
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| Cash burn | (700) | (133) | | (500) | (95) |
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| Cash at end of year* | 1,050 | 199 | | 1,250 | 237 |
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| * Cash, cash equivalents and marketable securities |
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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 June 30, 2009 of USD 1.00 = DKK 5.2689.
Conference Call
Genmab will hold a conference call to discuss the 2009 first half year results
tomorrow, Wednesday, August 19, 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:
+1 800 818 6852 (in the US) and ask for the Genmab conference call
+1 719 325 2457 (outside the US) and ask for the Genmab conference call
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, 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. 34/2009
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