Q&A Genmab 2019-03-04
Aktiesnakken
Genmab
Bavarian Nordic
NOVO
Zealand Pharma
TESLA
Amerikanske aktier
Gubra
BITCOIN
Shipping
AMBU
EL-BILER
Smallcap og First North aktier
Biotek-snakken
Grønne Aktier
Pharma
Vestas
Ennogie
Hansa Biopharma
Laks
GN Store Nord
ExpreS2ion
Krypto
Medico
Banker og Finans
Chemometec
Embla Medical
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..
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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?
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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...
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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.
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4/3 16:31 af Jan Van de Winkel |
..
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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?
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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...
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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..
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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.
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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...
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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..
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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?
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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...
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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..
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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 ?
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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..
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4/3 16:40 af Solsen |
Mr Winkel Could the approval process for dara sc include RTOR ?
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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...
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4/3 16:41 af Jan Van de Winkel |
As the SubCu formulation of Dara also involved Hyaluronise
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4/3 16:41 af Jan Van de Winkel |
sorry...
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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..
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4/3 16:43 af Helge Larsen/PI-redaktør |
Great. We have 2 questions more left for you.
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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 ?
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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..
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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 ?
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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...
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4/3 16:47 af Jan Van de Winkel |
Our priority for capital allocation remains investing in our exciting product pipeline..
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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.
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4/3 16:48 af Jan Van de Winkel |
Thank you again for a lively session and looking forward to interact again in May..
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4/3 16:49 af Helge Larsen/PI-redaktør |
This session have ended.
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