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10/8 13:57 af Helge Larsen/PI-redaktør |
Jan and David. Are you online?
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10/8 13:57 af Jan Van de Winkel |
Yes, we are here. Looking forward to talking to you.
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10/8 13:58 af Helge Larsen/PI-redaktør |
:-)
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10/8 13:59 af Helge Larsen/PI-redaktør |
Jan van de Winkel and David Eatwell. Welcome to Q & A here on ProInvestor.com. We are very happy to have you back here and ready to answer questions from our investors.
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10/8 13:59 af Jan Van de Winkel |
Looking forward. Thank you for hosting us.
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10/8 13:59 af Helge Larsen/PI-redaktør |
First of all let me congratulate on the great results for Q2 . Can you give us a short-term update on key figures and important events?
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10/8 14:00 af Jan Van de Winkel |
Key figures: revenue for H1 1024 mn kr 95% vs 2016...
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10/8 14:00 af Jan Van de Winkel |
expenses at 21% operating income at 582 mn which I s268% up since last year...
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10/8 14:01 af Jan Van de Winkel |
cash is at 5.2 bn DKK......
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10/8 14:01 af Jan Van de Winkel |
Janssen DARZALEX sales 554 mn USD vs 209 last year, and royalty of DKK 454...
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10/8 14:02 af Jan Van de Winkel |
Key business highlights. US approval for dara + Pomalyst....
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10/8 14:02 af Jan Van de Winkel |
EU approval for dara in secondline combination with certain standard treatments in April....
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10/8 14:02 af Jan Van de Winkel |
tisotumab vedotin, encouraging prelim. data in cervical cancer....
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10/8 14:03 af Jan Van de Winkel |
and many more highlights detailed in the report.
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10/8 14:03 af Sibelius |
Question: How is the large cash position managed? Is there a hedging policy in place to adress currency and interest movements?
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10/8 14:05 af Jan Van de Winkel |
in terms of the FX the hedging - its probably easier to read the annual report note 4.2...42mn USD of royalties is hedged at a rate locked in. Marketable securities are all high quality assets with short term durations.
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10/8 14:06 af bibob |
Mr Winkel. In your first half you have higher financial costs. What did the more costs been used for. ?
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10/8 14:07 af Jan Van de Winkel |
The 171 mn DKK
net financial item expense was impacted by FX movements impacting the USD portfolio and cash holdings
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10/8 14:08 af Budweis |
In a couple of interviews have you indicated that your (J&J / Genmabs) internal sales estimates for Darzalex were higher than the bank analysts. How do you see that indications after the market introduction and what are you internal sales expectations for 2020 (compared with the bankers)?
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10/8 14:09 af Jan Van de Winkel |
The launch of DARZALEX is going extremely well. We are confident about the peak sales model, with analysts average peak sales at 8.5 bn USD in MM.
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10/8 14:10 af Joakim Von And |
Are production of darzalex able to follow the growing market or happens restorders ?? Productionlines must / may extend rapidly over the last years. I think the last month sale was a slight disapointing and that could be because of restorders/ productionsproblems
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10/8 14:12 af Jan Van de Winkel |
We don't look at sales on a month by month basis, but concentrate on Q by Q sales. Also the June sales were not disappointing. DARZALEX sales in Q2 were actually 17% higher than in Q1.
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10/8 14:12 af transalp |
Thanks for you spend time with us here at proinvestor.. Means a lot to us.. Jan i understand why you give your co workers, warrents.. Genmab is if any firm, the result of people with fantasic knowledge and workeffort. How do you devide warrents between you? It is both to keep important research inside and to reconice a secretarys effort?
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10/8 14:14 af Jan Van de Winkel |
Genmab is about teamwork, and everybody contributes to building a success. Therefore, we want recognize everyone's contribution by giving them warrants....
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10/8 14:14 af Jan Van de Winkel |
Biotech is a global industry and this is quite a normal practice.
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10/8 14:15 af Raffles |
What is the next step in relation to the patent case (Morphosys AG) and what is the timing?
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10/8 14:15 af Jan Van de Winkel |
We cannot comment on an active cases.
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10/8 14:16 af E L |
What do you see as the biggest competitor for Dara? Do you see CAR-T therapy as a serious threat?
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10/8 14:16 af Jan Van de Winkel |
There are not many active competitors for dara...
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10/8 14:17 af Jan Van de Winkel |
perhaps some of the 'new' checkpoint blockers could turn out to be active in the same therapeutic area, but we really view dara as a backbone treatment ie a drug that can be an ideal combination partner for other drugs...
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10/8 14:18 af Jan Van de Winkel |
as it relates to CAR-T, this is more of a procedure than a traditional medicine. Potentially more suited to end stage patients in limited numbers of clinical centres.
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10/8 14:18 af Sukkeralf |
Will Janssen still present data from the Carina study this year ?
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10/8 14:19 af Jan Van de Winkel |
We don't control when data will be published, but we have learned from Janssen that they intend to publish the Carina data.
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10/8 14:20 af bongobob |
Since Daratumumab has shown effect in CLL by ADCC do you think we will see combination studies with Ofatumumab
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10/8 14:21 af Jan Van de Winkel |
The top priorities for dara are multiple myeloma and solid cancers. We expect to see an increasing number of ISS studies in other cancers. These could include CLL.
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10/8 14:21 af Bulder |
Is the combination of panobinostat and dara ready for use, since both pano and dara are approved? Or does it need a specifical approval from the authorities?
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10/8 14:22 af Jan Van de Winkel |
Both drugs are on the market and could in theory be used for combination treatment but it is not an approved indication for dara.
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10/8 14:22 af Raffles |
OFA - Regarding Complement A+B study. Patient enrollment was completed in May 2017. What is the expected next step and what is the timing ?
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10/8 14:23 af Jan Van de Winkel |
We still expect data to become available in the second half of this year.
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10/8 14:24 af Bulder |
If it is decided to go further with JNJ...957, will that include a sc-version of it?
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10/8 14:25 af Jan Van de Winkel |
This is a Janssen product, where we get royalties and milestones but Janssen is responsible for positioning and development.
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10/8 14:25 af Raffles |
AMG714 had primary completion date in june-17. What is the expected next step and what is the timing ?
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10/8 14:26 af Jan Van de Winkel |
This is a product that is out-licensed to Celimmune by Amgen, so they are responsible for positioning and further development.
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10/8 14:26 af Raffles |
What is the expected next step for HuMax IL8 (Solid tumors / BMS) and what is the timing?
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10/8 14:27 af Jan Van de Winkel |
This product is now developed and positioned by BMS so they control further development and timing.
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10/8 14:27 af Raffles |
TisotumabVedotin. It is expected that data will be presented at ESMO in Madrid in Sept. When can we expect to get a decision from Seattle Genetics regarding their future involvement? If SG decide to opt-in, will there be a payment to Genmab (Cost covering)?
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10/8 14:28 af Jan Van de Winkel |
Seattle Genetics has an option where they can exercise the option at the end of the Phase I/II study. But of course there is always a possibility for an opt in before that but that would be up to Seattle Genetics.
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10/8 14:29 af Sukkeralf |
How many DuoBody programs have Janssen activated and do Janssen expect more IND´s this year ?
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10/8 14:29 af Jan Van de Winkel |
The analysts covering Genmab have overall a very similar view of the DARZALEX/dara case, the JNJ analysts might have a more mixed view because the JNJ business is more than just pharma.
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10/8 14:30 af Jan Van de Winkel |
12 activated programs with 8 clinical candidates and three active clinical programs under the Janssen DuoBody
collaboration
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