Genmab A/S (GMAB) 2005 Q1 法說會逐字稿

Good morning and welcome, ladies and gentlemen, to the Genmab conference call. At this time I would like to inform you that this conference is being recorded and that participants are in a listen-only mode. At the request of the Company we will open the conference up for questions and answers after the presentation.

During this telephone conference you may be presented with forward-looking statements that include words such as "believes", "anticipates", "plans" or "expects". Actual results may differ materially; for example, as a result of delayed or unsuccessful development projects. Genmab is not under any obligation to update statements regarding the future nor to confirm such statements in relation to actual results unless this is required by law.

I will now turn the conference over to Dr. Lisa Drakeman, Chief Executive Officer of Genmab.

Good afternoon, good morning to any of you calling in from the United States, and welcome to the Genmab first-quarter results conference call. If you've seen our press release you know that we had results that were consistent with previously published guidance for 2005. The net loss for the quarter was DKK100.9 million, operating loss was 108, and we also had cash at the end of the quarter of DKK1.102 billion which is approximately $192 million U.S. I would like to remind people that we are accounting for stock options in 2005 and that that helps explain some of the increase in operating loss this year.

We also had some very exciting highlights during the first quarter of 2005. For HuMax-CD4 we had encouraging duration of response data from the Phase II study showing that patients were maintaining their responses on average for ten and a half months. This appears to be an advantage over other products that are currently on the market. This product is now in Phase III under a special protocol assessment process agreement with the U.S. FDA to treat patients who have failed other therapies.

We also completed enrollment with the HuMax-CD20 Phase I/II study to treat patients who had chronic lymphocytic leukemia who had failed standard therapy. We expect to have data from this study later this year.

Genmab was honored to receive the James D. Watson Helix Award in the international category for the Company's achievements in 2004. The Helix Award honors biotechnology companies that display leadership in scientific innovation, company growth and corporate citizenship. I think this is a tribute to the entire Genmab team because everyone worked together to achieve the goals of 2004 and we do plan to take accomplishments of 2004 and use them to help continue the development of the Company this year.

Finally, during its first-quarter results presentation, Amgen announced it had completed dosing in the AMG 714 Phase II rheumatoid arthritis study. While Amgen has not said publicly when they expect to make the data from this study available, we all hope that we will see it sometime this year.

Today on the call I'm joined by Bo Cruza; he's our Chief accounting officer, the person who oversees our reporting and our finance group. With that I would like to turn this call over to all of you who have joined us for any questions you may have.

(OPERATOR INSTRUCTIONS). Annette Rye Larsen, Gudme Raaschou.

It's Annette Rye Larsen. I have a question regarding the CD4 trial where you have now been granted this SPA. And I wonder about these 18 patients that you need to treat ahead of the 70 patients, what kind of impact does that have on the timeline for the Phase III trial?

Actually when we talked about the Phase III trial because the 18 patients are part of it, we say that we expect, assuming enrollment goes as we plan, to have this study finish in about a year from now. So the overall timing for the study is as we had previously said. We hope to be finished by about a year from today and then we also hope that we'll be able to put our information together and file for approval before the end of 2006.

Okay. And can I ask also another question? Regarding the CD20 in rheumatoid arthritis, when did you start to enroll patients for that?

You may recall that we said the U.S. FDA had allowed our IND in December and we started enrolling patients in January. That study has been ongoing for a few months now with patient accrual.

Okay, thank you.

(OPERATOR INSTRUCTIONS). If there are no further questions I will now turn the conference back to Ms. Drakeman.

Thank you all for joining us today. It looks like Bo and I are off the hook pretty easily. We look forward to talking to you again in the future and to also moving Genmab forward as the year progresses. Thank you and good-bye.

Ladies and gentlemen, this concludes our conference call for today. Thank you for participating and have a nice day. All parties may now disconnect.