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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER
23/11 11:41
af Helge Larsen/PI-redaktør
Denne session starter den 27. november kl. 16.
27/11 16:58
af Helge Larsen/PI-redaktør
Hi Jan van de Winkel. Are you online?
27/11 16:58
af Jan Van de Winkel
Absolutely, and eager to hear your questions.
27/11 16:59
af Helge Larsen/PI-redaktør
Good afternoon Jan van de Winkel. 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.
27/11 17:00
af Helge Larsen/PI-redaktør
Can you give us the financial highlights and the key achievements in Q3.
27/11 17:00
af Jan Van de Winkel
We have seen significant advances in our and our partners’ pipelines throughout 2020 and the third quarter was no exception..
27/11 17:00
af Jan Van de Winkel
On a single day in August, the U.S. FDA granted approvals to Novartis for Kesimpta in relapsing MS and to Janssen for the eighth multiple myeloma indication for DARZALEX. The Kesimpta approval was highly anticipated and we were very pleased that RMS patients in the US had this convenient treatment option approved nearly a month earlier than expected..
27/11 17:01
af Jan Van de Winkel
In July we dosed the first patient in an expansion cohort for epcoritamab and we look forward to presenting further epcoritamab data very shortly at the upcoming ASH conference..
27/11 17:01
af Jan Van de Winkel
In August we saw the start of the first-in-human trial of DuoBody-CD3x5T4. Recall that we are developing both epco and DuoBody CD3x5T4 as part of our broad Oncology collaboration with AbbVie..
27/11 17:02
af Jan Van de Winkel
In September, we presented key data for tisotumab vedotin, which we are developing with Seagen, from the Phase 2 innovaTV 204 trial during a late-breaking oral presentation at ESMO. Based on these results we, together with Seagen, look forward to submitting a BLA to the FDA under the accelerated approval pathway..
27/11 17:03
af Jan Van de Winkel
Since the end of the third quarter, we have kept busy with a number of exciting things. In October we submitted the IND for HexaBody-CD38, the second IND Genmab submitted this year. Earlier this month, we presented the first clinical data for DuoBody-PD-L1x4-1BB, a major milestone in our collaboration with BioNTech, at the SITC annual meeting..
27/11 17:03
af Jan Van de Winkel
Finally, earlier this week, we announced that we are discontinuing the development of enapotamab vedotin since the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept..
27/11 17:04
af Jan Van de Winkel
Financial highlights:.. In the first nine months of the year, Revenue came in at 8.1 billion Danish Kroner an increase of nearly 5.6 billion Kroner compared to the first nine months of 2019..
27/11 17:04
af Jan Van de Winkel
The increase was primarily driven by the upfront payment from AbbVie and higher DARZALEX royalties..
27/11 17:04
af Jan Van de Winkel
Darzalex showed continued strong performance in the third quarter, with the first single quarter sales over $1 billion dollars for Q3..
27/11 17:04
af Jan Van de Winkel
Total expenses in the first nine months of 2020 were 2.6 billion Kroner, with 84% being R&D and 16% G&A..
27/11 17:04
af Jan Van de Winkel
Operating income was 5.4 billion Kroner compared to 462 million in the first nine months of 2019, driven by higher revenue, bringing us to our net income of 4.2 billion Kroner..
27/11 17:05
af Jan Van de Winkel
So, an extremely strong 2020 so far, despite the COVID-19 pandemic..
27/11 17:05
af Jan Van de Winkel
Now, let us turn to your inspirational questions.
27/11 17:05
af Sukkeralf
After discontinuing enapotamab vedotin whats your view on AXL as a target?
27/11 17:06
af Jan Van de Winkel
AXL is more challenging than anticipated on the basis of the preclinical work, but may well be pursued as a target for cancer therapy with combinations of therapeutics.
27/11 17:06
af Sukkeralf
Have Genmab any active research into other classes of antibodies besides IgG?
27/11 17:07
af Jan Van de Winkel
In our preclinical and research team we also work on other classes of antibodies for novel therapeutic concepts. None of these are yet ready for clinical evaluation.
27/11 17:07
af E L
Genmab recently had an application for an Infectious Diseases Scientist. Could you say something about the ”Genmab Infectious Disease initiative”? Is it only cancer related or is it broader? Is it related to your partnership with ImmunoPrecise as they announced last week?
27/11 17:09
af Jan Van de Winkel
Genmab ID is evaluating some of our next gen antibody platforms for a number of infectious pathogens. This in order to assess whether our unique next gen platforms provide a benefit for treatment of diseases caused by these pathogens.
27/11 17:10
af GeorgeBest
You have previously mentioned that you aim to narrow the gap timewise for getting epcoritamab to marked compared to the Roche cd3/cd20 drug candidates. Are there any indications that you succeded in narrowing the gap?
27/11 17:11
af Jan Van de Winkel
We are very actively broadening the clinical programs for epcoritamab and are making excellent progress on multiple fronts..
27/11 17:12
af Jan Van de Winkel
Currently the Corona Virus is impacting our programs in some clinical sites, but this impact may be smaller than the impact the pandemic has on large phase 3 studies by other parties. So in that sense, we are progressing to further limit the gap between us and competitors.
27/11 17:13
af GeorgeBest
Do you expect to send any new preclinical candidates to the clinic next year?
27/11 17:14
af Jan Van de Winkel
In the coming months, we expect HexaBody-CD38 to move into patients. On top of that, we also anticipate other next generation therapeutics to progress towards the clinic. Early next year we expect to provide further color on such programs.
27/11 17:14
af GeorgeBest
AbbVie has 4 more options to select candidates from Genmabs pipeline. When do you expect news about this? Can they choose both clinical and preclinical candidates?
27/11 17:16
af Jan Van de Winkel
We have a research agreement with AbbVie where Genmab and AbbVie jointly work on entirely new programs, either using Genmab antibodies or AbbVie antibodies in combination with Genmab's DuoBody technology or AbbVie's new ADC technologies to create entirely new product candidates..
27/11 17:17
af Jan Van de Winkel
So now picking and choosing from Genmab's proprietary product pipeline, but newly creating product options in the partnership.
27/11 17:17
af GeorgeBest
When do you expect any INDs from the CureVac and Immatics cooperation, and could we also expect more INDs from the BioNTech cooperation?
27/11 17:18
af Jan Van de Winkel
We are making good progress on all of these partnerships and definitely expect INDs to result from these. Stay tuned for timing.
27/11 17:18
af GeorgeBest
How big is the amyloidosis market in percentage compared to multiple myeloma marked?
27/11 17:19
af Jan Van de Winkel
Most analysts currently predict a market between 500 and 750 mio USD. This is considerably smaller than the multiple myeloma market.
27/11 17:20
af E L
Novartis this week mentioned Kesimpta had a 5,2% NBRx share just 10 weeks post launch; can you tell us roughly how many actual patients have started since the launch?
27/11 17:20
af Jan Van de Winkel
This is a question for Novartis. We are thrilled with the update from our partner and cannot wait to see the sales number for Q4.
27/11 17:21
af peter12
Novartis announced they will give away Kesimpta for free in a period, but will Genmab receive royalties anyway ?
27/11 17:21
af Jan Van de Winkel
Genmab receives royalties on net sales.
27/11 17:22
af E L
You are hoping to file your BLA for Tisotumab Q1 ’21; should we expect simultaneous filings in the US, Europe and Japan?
27/11 17:22
af Jan Van de Winkel
The initial filing will be in the US. The next one is currently anticipated in Japan.
27/11 17:23
af Solsen
Mr Winkel How will Genmab book the revenue if Epco gets an approval - as sales - which markets or as royalties ?
27/11 17:24
af Jan Van de Winkel
Genmab will book the net sales for both the US and Japan, and will receive royalties from AbbVie for the ROW sales.
27/11 17:24
af Solsen
Mr Winkel Could you give us some timeline on the epco to the market. Just wonder if your statement on Genmabs 2025 vision could be realised some years earlier referes to epco.
27/11 17:25
af Jan Van de Winkel
We anticipate that the next product reaching the market will be tisotumab vedotin, followed by epcoritamab if all goes well.
27/11 17:25
af Solsen
Mr Winkel Do you se a risk in Teclistamab/Talquetamab taking marketshare from Dara if approved ?
27/11 17:26
af Jan Van de Winkel
We don't see teclistamab and talquetamab as competitors but as combination therapeutics with daratumumab.
27/11 17:26
af Solsen
Mr Winkel Livertox in GEN1046 seems to bother analyst and investors. Genmab sees less concerned as patiens with livertox can continue on GEN1046. Do you see dose depend livertox or PD-L1 saturation depend livertox. Could livertox be a PD-L1 issue as we se cases in mono PD-1/PD-L1 drugs ?
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