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4/3 16:49
af Helge Larsen/PI-redaktør
This session have ended.
4/3 16:48
af Jan Van de Winkel
Thank you again for a lively session and looking forward to interact again in May..
4/3 16:48
af Helge Larsen/PI-redaktør
Jan and David. This was all we had for you this time. Thank you for joining us and thank you for the many fulfilling answers to the broad range of interested questions from our investors here at ProInvestor. com. We look very much forward to having you back again here for a Q&A in the near future after Q1.
4/3 16:47
af Jan Van de Winkel
Our priority for capital allocation remains investing in our exciting product pipeline..
4/3 16:47
af Jan Van de Winkel
We need to get the authority from the AGM first before being able to buy back shares...
4/3 16:46
af Solsen
Mr Winkel Could you sheed some light on the future capital structure now Genmab are heading towards 10 bn DKK in the bank. You opens for buy back of new 500.000 shares at the annual meeting (ca 1 mln in all). But when will you do it and will more come. And are dividend an issue now ?
4/3 16:45
af Jan Van de Winkel
We are entitled to some small milestones and mid-single digit royalties on sales. We are very excited with the recent clinical data of Tepro in Graves' Eye Disease which may lead to the first drug ever approved for treatment of these patients..
4/3 16:43
af Solsen
Mr Winkel/Eatwell After many years Teprotumumab seems to be on the track for marketing - congrats. Could we hear something about the value for Genmab - like milestones and royalty ?
4/3 16:43
af Helge Larsen/PI-redaktør
Great. We have 2 questions more left for you.
4/3 16:42
af Jan Van de Winkel
Hyalironidase, and thus is a new combination of two active ingredients, we believe RTOR would not apply..
4/3 16:41
af Jan Van de Winkel
sorry...
4/3 16:41
af Jan Van de Winkel
As the SubCu formulation of Dara also involved Hyaluronise
4/3 16:41
af Jan Van de Winkel
RTOR is a pilot programme from the FDA for drugs that are already approved in the market and seek a broader label...
4/3 16:40
af Solsen
Mr Winkel Could the approval process for dara sc include RTOR ?
4/3 16:40
af Jan Van de Winkel
Princing of Daratumumab formulations is the responsibility of our partner Janssen. As the SubCu formulation is not yet approved for therapy of MM, it is too premature to speculate on perceived prices in some European countries..
4/3 16:38
af nohope
How is the total economy in the Dara sc for patients ? Could the pricing of the Dara sc formulation be so high that the product is rejected by NICE and other similar institutions - despite great advantages ?
4/3 16:38
af Jan Van de Winkel
We are confident that the availability of a SubCu formulation in 2020 will have a very positive effect on usage of Daratumumab at all sites..
4/3 16:37
af Jan Van de Winkel
We know that in major medical centres in the US, the split dosing regimen is used frequently. Unfortunately, in the large community healthcare centers that are key for treatment of MM, far less use of the split dosing regimen was observed up to now. We estimate that this usage will now go up, as Janssen can now promote for the split dosing alternative more broadly...
4/3 16:35
af Vester
One could be worried that the potential dara 1st line sales in 2019 could be greatly limited by the treatment bottleneck issue. Do you expect the split dosing to have a significant impact on the dara treatment capacity?
4/3 16:35
af Jan Van de Winkel
In the second half of 2019 we expect meaningful data in at least 4 other solid tumors with T.V. Right now, it is too premature to speculate on market potential before any data readout..
4/3 16:34
af Jan Van de Winkel
With regards to cervical cancer, we are rapidly progressing recruitment in the PHII cervical cancer study and are also making plans to enter other lines of therapy...
4/3 16:33
af Darvin
Two questions about Tisotumab. We know that Tiso is progressing well in cervical cancer. Genmab has also talked about high expectations in eg. Pancreatic Cancer - perhaps greater than Cervical. First - Can you tell us something new here. Second - In what area do you se the biggest potential for Tisotumab.
4/3 16:33
af Jan Van de Winkel
The scientific team has not compared E.V. with ADCT-601, we do note that the payload used by ADC-Therapeutics is far more toxic in cancer patients than MMAE..
4/3 16:32
af Jan Van de Winkel
We can confirm that Genmab also has active programs on companion diagnostics and biomarkers for E.V. at present...
4/3 16:31
af Sukkeralf
BergenBio is probably in front with their selective AXL inhibitor bemcentinib (small molecule) and they have shown good progress with their biomarker companion diagnostic - two questions: Are Genmab actualy working on a biomarker companion diagnostic for EV? Have you compared preclinical data for AXL ADC with ADCT-601 and can elaborate on that?
4/3 16:31
af Jan Van de Winkel
..
4/3 16:31
af Jan Van de Winkel
With regard to the second question, the first half of 2020 is too optimistic for E.V.
4/3 16:30
af Jan Van de Winkel
With regard to the first question, we first need to see clinical data before any projections can be made on approval timelines etc...
4/3 16:29
af Darvin
Two questions about Enapotamab vedotin. First - when the current Phase 2 trial is completed, what trials / actions are then needed before you can apply for approval and marketing authorization? Second - Do you see EV on the market in the first half of 2020?
4/3 16:29
af Jan Van de Winkel
We have a very productive and stimulating partnership with BioNTech from which the first two clinical candidates are close to IND/CTA filings, and there is more to come..
4/3 16:28
af Jan Van de Winkel
The acquisition of MAB Discovery has no impact on some of the work performed by this company for Genmab...
4/3 16:28
af Sukkeralf
Mab Discovery was recently bought by BioNTech - does that impact your deal with Mab Discovery? Are the BioNTech/Genmab DuoBody partnership still active besides the two 4-1BB BsAbs?
4/3 16:27
af Jan Van de Winkel
As communicated to the market, we feel that a targeted smaller market could be handled by Genmab without a partner. If the therapeutic would be active in larger market, a partnership makes best sense..
4/3 16:26
af Jan Van de Winkel
It is too early to say whether we want to partner E.V. as we do not have robust clinical data at present...
4/3 16:25
af Thomas
Do you expect to partner up on Enapotamab?
4/3 16:25
af Jan Van de Winkel
As Genmab intends to hold on to 50% or more of the product rights, the negotiations of contracts and future partnerships is more complicated and lengthy..
4/3 16:24
af Jan Van de Winkel
We are currently actively evaluating the HexaBody platform for a number of targets, some of these in collaboration with (future) partners...
4/3 16:23
af Thomas
In the Capital markets day in 2016 we heard that potential partners were queueing up interested in doing deals on the Hexabody platform. Why havent we seen any deals?
4/3 16:23
af Jan Van de Winkel
In order to obtain a broader label, we would also need to obtain safety data from the PLEIADES study which is evaluating 3 cohorts of patients DARA + RD, DARA + VMP and DARA + VRD. If this study reads out positively, we expect to obtain a broad label for SC DARA..
4/3 16:21
af Jan Van de Winkel
The COLUMBA study is the only non inferiority PHIII that would be needed to obtain a label for SC daratumumab...
4/3 16:21
af Bulder
Can data from the Columba study be the basis for approval in all treatment lines in MM, or do we have to await the sc combo study MMY2040?
4/3 16:20
af Jan Van de Winkel
We currently E.V. for solid tumors that are known to over-express AXL. In the second half of this year, we expect meaningful data from all expansion cohorts and may want to broaden the range of tumors for testing E.V..
4/3 16:19
af JStudsgaard
After skin cancer, breast cancer is the most common cancer diagnosed in women. About AXL, you write that it contributes to tumor progression in breast cancer among others. Why are you not including Breast cancer in your trials with HuMax-AXL-ADC ?
4/3 16:19
af Jan Van de Winkel
We do anticipate approval in the second half of 2019..
4/3 16:18
af Bulder
Did Janssen achieve Priority Review for Alcyone in Japan? If so, is it also 6 months?
4/3 16:17
af Jan Van de Winkel
We can confirm that the numbers you quote are correct..
4/3 16:16
af Jan Van de Winkel
It depends how the pipeline develops and which projects move to later stage development. In addition it will depend on our partnering strategy..
4/3 16:16
af kkjoel
Mr Eatwell - given the 2685M DKK outlook on 2019 from a $3B Darza turnover at the 6 USD/DKK rate - and all our previos knowledge of the royalty-tiers - I tried to do the math (as you suggested on a few CCs;-). Would it be possible for you to confirm this full range (which hits spot-on for all the given numbers): 0-750 12%, 750-1500 13%, 1500-2000 16%, 2000-3000 18%, 3000- 20%?
4/3 16:16
af Jan Van de Winkel
At present, Janssen has over 95 clinical studies with Daratumamb, including over 14.500 patiens..
4/3 16:15
af Relax
Genmab has considerably expanded the cost of developing the pipeline for 2019! Can investors expect these costs to accelerate further over the coming years? If so, is their an estimate of how much will be invested before results can be expected?
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