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2/3 16:51 af Helge Larsen/PI-redaktør |
In 10 minutes we begin the online Q&A with Genmab.
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2/3 16:57 af Helge Larsen/PI-redaktør |
Are you with us here online Jan?
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2/3 16:57 af Jan Van de Winkel |
Yes I am here with David Eatwell Genmab's CFO.
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2/3 16:57 af Jan Van de Winkel |
Looking forward to speaking with you all.
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2/3 16:58 af Helge Larsen/PI-redaktør |
Welcome to CEO Jan van de
Winkel and CFO David Eatwell to ProInvestors Q & A. We are very glad to have you back here on ProInvestor.com and ready to answer questions from our investors.
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2/3 16:59 af Jan Van de Winkel |
Thank you, looking forward to some good questions as always.
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2/3 16:59 af Helge Larsen/PI-redaktør |
Great. First of all let me just congratulate on the great results for 2015 .
Can you give us a short-term update on key figures and important events in quarter 4 and for 2015.
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2/3 17:00 af Jan Van de Winkel |
Let's start with the key figures (from David). Highest ever revenue....
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2/3 17:00 af Jan Van de Winkel |
at over 1.1bn DKK, flat expenses for the fifth year in a row...
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2/3 17:01 af Jan Van de Winkel |
highest ever operating income at 730 mn DKK. Up 465 on 2014. Cash position 3.5 bn at the end of the year.
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2/3 17:01 af Helge Larsen/PI-redaktør |
About your goals for 2016: Which do you consider the most important for Genmab?
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2/3 17:01 af Jan Van de Winkel |
Highlights for this 2015: DARZALEX approval in November was of course the biggest highlight of the year....
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2/3 17:02 af Jan Van de Winkel |
Highlights for 2016 - we are hoping for an approval in Europe for DARZALEX....
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2/3 17:03 af Jan Van de Winkel |
we expect to get interim results for two key phase three combination studies in second line MM. And if positive we hope to file in both the US and EU....
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2/3 17:03 af Jan Van de Winkel |
Furthermore, we hope to see initiation of clinical studies in MS by our partner Novartis with subcue ofatumumab....
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2/3 17:04 af Jan Van de Winkel |
and we hope to see further data with tisotumab vedotin in the second half of this year as well as initiation of clinical work with HuMax-AXL-ADC.
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2/3 17:05 af Helge Larsen/PI-redaktør |
As for the European market - in case of an approval of Darzalex - will we then experience an equally rapid roll out similar to the one in USA? And: How do you estimate the potential for the sale in Europe in percents compared with USA?
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2/3 17:05 af Jan Van de Winkel |
It will of course take time in Europe to negotiate pricing on a country to country basis, however we anticipate a rapid launch in some countries such as Germany following approval.
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2/3 17:07 af Helge Larsen/PI-redaktør |
To what extent will such a successful outcome of the Phase 3 studies Pollux and Castor affect the sale of Darzalex? Somewhere I saw you quoted, for saying that it will “increase sales dramatically in the United States”. It the quote is correct, what do you consider “a dramatic increase”?
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2/3 17:08 af Jan Van de Winkel |
If the data at the interims is positive and hits the primary endpoint, the next steps for Janssen will be to file in 2016 leading to a broader label. Second line is of course, a much larger market than the last line fourth therapy.
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2/3 17:09 af MUFC Oberanven |
Question about pricing of Castor and Pollux when they hit the market: As I see it, it will be very expensive products, because you combine 3 products who each are very expensive. Should we expect prices in the area of USD 300t per year? How are the prices compared to other combo products?
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2/3 17:10 af Jan Van de Winkel |
Janssen have priced very competitively in the US. DARZALEX is slightly lower than the competing drugs in the first year, however, it becomes much cheaper in the second year of use as there are fewer doses.
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2/3 17:10 af investor1989 |
The Castor and Pollux studies recruited patients with rocket speed. Can you tell how recruitment are going in the two front line studies?
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2/3 17:11 af Jan Van de Winkel |
The US price for the first year is 135,000 USD and for the second year is 76,000 USD.
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2/3 17:11 af Jan Van de Winkel |
Furthermore...both Velcade and Revlimid will become generic in the coming years. So likely resulting in less costly combi therapies. ....
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2/3 17:12 af Jan Van de Winkel |
re the three frontline studies in MM, they are all recruiting well.
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2/3 17:12 af Sukkeralf |
If Daratumumab interim data for Pollux and/or Castor are good enough for filing - then it´s a sBLA right ?
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2/3 17:12 af Jan Van de Winkel |
Yes, correct.
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2/3 17:13 af Sukkeralf |
Jan how do you think Janssen will position Daratumumab/Vecade against Daratumumab/Kyprolis or Daratumumab/Ninlaro in the comming years?
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2/3 17:14 af Jan Van de Winkel |
The strategy is to make daratumumab the solid backbone regimen for treatment of MM. In that context, it could be combined with a number of PIs and IMiDs...!
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2/3 17:18 af investor1989 |
You said on the conference call weekly uptake on Dara sales from IMS was up pretty well every week . Now 3 weeks later, are the data still the same with nice uptake?
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2/3 17:19 af Jan Van de Winkel |
We saw IMS data at around 26 mn USD for January which is well above the 16 mn USD we saw for December.....
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2/3 17:19 af Jan Van de Winkel |
which is nice progress and we look forward to watching over the coming months.
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2/3 17:19 af investor1989 |
Darzalex royalty is currently 12 % and moving to 20 % above 3 bio. $ in sales. Should we calculate with a linear uptake from 12 to 20 % between 0 and 3 bio. $ in sales or can you tell anything here?
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2/3 17:20 af Jan Van de Winkel |
There are several tranches - unfortunately we cannot provide more detail.
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2/3 17:21 af Tattitappi |
First of all, a big thank you for taking part in this Q&A. My first question is as follows: 1) You mentioned about a possible opt-in by Seattle Genetics later in 2016. Does this opt-in include any major future plans with Seattle Genetics or is it a one-off deal? Second, how would you comment on the latest prognosis of Darzalex sales? Does the prognosis differ from the initial reports which were presented during the Q&A after 2015 year s
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2/3 17:22 af Jan Van de Winkel |
In answer to the question on the Seattle Genetics opt in for tisotumab vedotin...
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2/3 17:23 af Jan Van de Winkel |
Seattle have an opt in right after Phase 1 data, and if they choose to opt in, then we would split the product rights and costs 50/50. This is unique to this tisotumab vedotin program.
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2/3 17:24 af Jan Van de Winkel |
With regards to question 2 - we confident that we can reach the guidance for 2016. it is too early to provide more accurate projections of sales at this time.
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2/3 17:25 af jkj |
as you probaly know nordea recently has estimated the turnover for dara to be around 30 mio. dollars for jan, 2016.
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2/3 17:25 af jkj |
whit that in mind, and as we know, you also follows that prescription for dara. Do you have any knowledge, whether we should expect the same rapid progress.
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2/3 17:26 af Jan Van de Winkel |
We use IMS data to track DARZALEX sales, and we are very encouraged by the progress so far.
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2/3 17:26 af Sukkeralf |
Will the Halozyme sc version of Daratumumab be something Janssen will take forward as quickly as possible or should we look at it more of a life cycle management kind of thing ?
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2/3 17:26 af Jan Van de Winkel |
The subcue is in Phase 1 and progressing well.
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2/3 17:27 af maskinerne |
To what extend have you seen injection site reactions in cohort 1 and 2 in your subcu studies on Dara?
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2/3 17:27 af Jan Van de Winkel |
It is too early to have any data from this study.
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2/3 17:27 af Sukkeralf |
For Daratumumab outside MM which indications are you pursuing besides FL, DLBCL and MCL (or if you can´t mention which indications maybe just confirm if we will see clinical trials outside MM, FL, DLBCL and MCL in 2016) ?
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2/3 17:28 af Jan Van de Winkel |
We currently have the NHL trial that you reference ongoing. We expect progress outside of NHL and MM in the future.
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2/3 17:29 af Bo Benn |
Considering the hit Arzerra sales has taken due to competition in CLL, could you expand a little on the label extension strategies in cancer, both in CLL and NHL (and other potential indications), to perhaps boost future cancer revenue from that product?
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2/3 17:31 af Jan Van de Winkel |
There are several studies ongoing and Novartis intends to file in the secondline CLL setting. All of these can lead to a broader label. We are also very excited to hear about Novartis' plans in Autoimmune diseases.
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