COPENHAGEN, August 27 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today results for the six month period ended June 30, 2008. During this period, Genmab reported the following results:
Genmab’s revenues were DKK 277 million (USD 59 million) for the first half of 2008. In the same period of 2007, Genmab recognized revenues of DKK 280 million (USD 59 million).
An operating loss of DKK 471 million (USD 100 million). This compares to an operating loss of DKK 119 million (USD 25 million) reported for the corresponding period of 2007. The larger operating loss was driven by the increased level of pre-clinical and clinical activities associated with the advancement of our product pipeline.
Net financial income for the first half of 2008 reflected a net loss of DKK 20 million (USD 4 million), compared to a net income of DKK 32 million (USD 7 million) in the same period of 2007. The net financial income reflects a combination of interest income and fair market value adjustments from our portfolios of marketable securities and unrealized foreign exchange losses derived from the continued weakening of the USD against the DKK in the first half of 2008.
A net loss of DKK 491 million (USD 104 million) compared to a net loss of DKK 87 million (USD 18 million) for the same period in 2007. The net loss per share was DKK 11.02 (USD 2.33) for the first half of 2008 compared to DKK 2.01 (USD 0.42) in the first half of 2007.
Genmab ended the six month period with cash and marketable securities of DKK 2.1 billion (USD 443 million), which is a decrease of DKK 1.6 billion (USD 338 million) from the end of 2007. The decrease primarily arises from the DKK 1.2 billion (USD 240 million at the date of acquisition) acquisition of the manufacturing facility in March 2008.
Highlights
During the second quarter of 2008, Genmab achieved a number of business and scientific milestones, as follows:
We achieved a development milestone for ofatumumab (HuMax-CD20(R)) under the collaboration with GlaxoSmithKline (GSK). A milestone payment of DKK 29 million (USD 6 million) was triggered by the first patient participating in the Phase II study for the treatment of relapsing remitting multiple sclerosis (RRMS).
We announced a Phase I/II study to evaluate a subcutaneous route of administration of ofatumumab (HuMax-CD20(R)) in rheumatoid arthritis (RA).
We appointed David Eatwell as new Chief Financial Officer.
We initiated two Phase I/II studies of zalutumumab (HuMax-EGFr(TM)), one to treat colorectal cancer (CRC) and another study in combination with radiotherapy for the treatment of advanced head and neck cancer.
Subsequent to the balance sheet date:
We announced the positive top-line results from a Phase III pivotal study evaluating ofatumumab (HuMax-CD20(R)) in two groups of patients with chronic lymphocytic leukaemia (CLL). The study met the primary endpoint in both patient populations and the results from the secondary endpoints also supported the primary endpoint. This event also marked the achievement of a DKK 233 million (USD 49 million) milestone under the GSK collaboration agreement.
We announced plans to begin four studies of ofatumumab in CLL and NHL this year, including;
1) Phase III CLL front line chlorambucil combination study. This open-label, parallel-arm study will include 444 patients with previously untreated CLL.
2) Phase II CLL ofatumumab retreatment and maintenance treatment study. This study will examine the retreatment and maintenance treatment of refractory CLL patients who participated in the ongoing Phase III CLL study.
3) Phase II NHL ofatumumab retreatment and maintenance study. This study will examine the retreatment and maintenance treatment of refractory follicular NHL patients who participated in the ongoing Phase III NHL study.
4) Phase I study in Japan. The primary objective of the study is to evaluate the safety and tolerability of ofatumumab in Japanese relapsed/refractory follicular NHL and CLL patients.
We completed recruitment of 56 patients in the Phase II study of ofatumumab in combination with fludarabine and cyclophosphamide to treat CLL in previously untreated patients.
Amgen informed Genmab that it would discontinue development for AMG714 in psoriasis and RA based on disappointing results from recent clinical studies. Amgen is exploring options to maximize the value of this asset, but at this time no further internal development of a lead indication is planned.
Outlook
Genmab is maintaining its financial guidance for the net loss in 2008 in the range of DKK 800 to 900 million and projects a slightly improved operating loss of DKK 850 to 950 million compared to previous guidance of DKK 900 to 1,000 million. This is despite a lower revenue estimate, which is now anticipated to be in the range of DKK 850 to 900 million due to a slight change in the timing of some anticipated milestone events and lower net financial income which is now expected to be DKK 40 to 50 million. The savings are driven by a reduction in our research and development costs which is a result of our efforts to focus on the most critical programs in our portfolio in the most efficient manner. We therefore currently anticipate that we will start fewer new studies in 2008 than the 17 previously planned.
As of December 31, 2007, Genmab had cash, cash equivalents and short-term marketable securities of DKK 3.7 billion. For 2008, we project that our operations together with the DKK 1.2 billion acquisition of the manufacturing facility in Minnesota will lead to a year end cash position of DKK 1.7 to 1.8 billion (USD 359 million to USD 380 million), unchanged from previous guidance. The proportion of the budget spent on research and development, and on the ofatumumab program, also remain approximately the same as previous guidance.
Conference Call
Genmab will hold a conference call to discuss the 2008 first half year results tomorrow, Thursday, August 28, 2008, at
A live webcast of the call and relevant slides will be available at http://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 unmet medical needs. Using cutting-edge antibody technology, Genmab’s world class discovery, development and manufacturing teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab’s products and technology, visit http://www.genmab.com.
This press 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 http://www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this press 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-CD4(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
Stock Exchange Release no. 38/2008
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, M: +45-25-27-47-13, E: hth@genmab.com
CONTACT: Contact: Helle Husted, Sr. Director, Investor Relations, T:
+45-33-44-77-30, M: +45-25-27-47-13, E: hth@genmab.com
