Q&A Genmab 2021-03-23
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23/3 16:16 af Helge Larsen/PI-redaktør |
This session has ended.
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23/3 16:15 af Jan Van de Winkel |
Thank you for a great exchange of information. Looking forward to chat after Q1.
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23/3 16:15 af Helge Larsen/PI-redaktør |
Thank you for joining us and thank you for the many fullfilling answers to our questions. We look forward to seeing you back here on ProInvestor.com after Q1.
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23/3 16:14 af Jan Van de Winkel |
Genmab intends to bring one or two new products into the clinic each year. At present our entire product pipeline is built up of novel next-generation antibody therapeutics.
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23/3 16:13 af Jan Van de Winkel |
It is too early to provide timelines. We will only message specific timelines once a product candidate is slotted for introduction into the clinic..
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23/3 16:12 af GeorgeBest |
When do you expect the first candidates from collaboration with CureVac, Immatics or Blink moving into the clinic?
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23/3 16:12 af Helge Larsen/PI-redaktør |
And now to the last question.
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23/3 16:12 af Jan Van de Winkel |
This is related to the DuoBody platform, which is patent protected by Genmab.
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23/3 16:11 af GeorgeBest |
You have often mentioned the unique robottic technology which gives you an advantage compared to Roche and others when developing new duobody candidates. Why can‘t competitors copy that process?
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23/3 16:11 af Jan Van de Winkel |
It is up to Janssen to message on CASSIOPEIA part 2 filing.
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23/3 16:10 af rsharma |
Could you please discuss the progress of CASSIOPEIA Part 2 filing?
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23/3 16:09 af Jan Van de Winkel |
We currently anticipate data for Cepheus in 2021 and Janssen will determine what data will be used for potential filing.
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23/3 16:08 af rsharma |
When can we expect data updates on CEPHEUS? Will it be filed to regulators based on MRD- or will it require secondary endpoint analyses?
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23/3 16:08 af Jan Van de Winkel |
The development program for epco will expand significantly during 2021. We will comment on it in detail, once new trials appear on ct.gov. We also expect updated data from epco clinical evaluations during 2021 and will inform you on the timing once decided. 2022 would be the absolute fastest time for a filing.
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23/3 16:06 af soniarao2008 |
Can you discuss epcoritamab developments? When can we next expect data and filing? What indication would the first filing be in?
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23/3 16:06 af Jan Van de Winkel |
It is too early to comment here. Preclinically HexaBody-CD38 is far more potent than daratumumab and it depends on its clinical potency whether one would need high amounts of antibody for therapy in man. So we have to await data before we can say more about the need for a co-formulation.
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23/3 16:03 af troldmanden |
Hi Jan. I have a question regarding HexaCD38. Would that molecule still need HALO?
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23/3 16:03 af Jan Van de Winkel |
Analysts anticipate peak sales for tisotumab vedotin to be north of 500 mio USD a number of years from here. Genmab will obtain 50% of the income for TV.
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23/3 16:02 af StockBull |
What is the expected peak sale for Tisotumab Vedotin and when is it expected to peak. Whats the agreed royalty and for how long
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23/3 16:01 af Jan Van de Winkel |
However, if the data are really promissing and HexaBody-CD38 is clearly differentiated from daratumumab, Janssen could also opt in early so that they can put their military machine behind accelerated development of HexaBody-CD38. We are super excited that we are cuirrently testing this promising and unique CD38 targetted antibody in the clinic and cannot wait to see data.
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23/3 16:00 af Jan Van de Winkel |
Janssen has an option to opt in into the HexaBody-CD38 program and can in theory wait for the clinical data from two clinical studies that Genmab is operationalizing..
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23/3 15:58 af peter12 |
Could you tell anything about when Janssen could opt-in on GEN3014 Hexa-CD38, bearing in mind the trial now is ongoing ?
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23/3 15:58 af Jan Van de Winkel |
Genmab receives a nice mid-single digit royalty for all Teprotumumab sales.
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23/3 15:57 af Sukkeralf |
Horizon is using Halozymes technology to make a sc version of Tepezza - how is Genmabs situation here regarding royalties or could we end up with another arbitration ?
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23/3 15:57 af Jan Van de Winkel |
We expect a number of readouts for daratumumab in 2021, including phase III data.
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23/3 15:56 af Sukkeralf |
Any clinical readouts from dara maintenance this year?
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23/3 15:55 af Jan Van de Winkel |
It is too early to provide such numbers as Genmab is currently spending 50% of the operating costs for epco. As it relates to Ofatumumab, analysts estimate peaks north of 2.5 bn USD and we get a 10% royalty for Ofa in MS.
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23/3 15:53 af StockBull |
For Q&A: 1. The royalty that Genmab receive for Darzalex is around 17% (rough average) and its probably pure profit. How much profit is expected from the 50/50 partnership with AbbVie if Epcoritamab meet the expected peak sale. Just an approx. average percentage e.g. until expected peak sales reached. 2. What’s the expected peak sale for Ofatumumab and what is the royalty
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23/3 15:53 af Jan Van de Winkel |
We have seen a number of analysts following Novartis estimating peak sales for Kesimpta higher than 2.5bn USD.
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23/3 15:52 af Bulder |
How much would you estimate peaksale to be for Kesimpta?
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23/3 15:52 af Jan Van de Winkel |
TheJanuary data show that overall 25% of the patients in the US with MM are treated with Darzalex, 14% of the frontline patients, 45% of the 2nd line patients and 49% of the 3rd line patients.
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23/3 15:51 af Jan Van de Winkel |
I cannot comment on the list prices, but am pleased to inform you that we have seen very good sales recently via IMS in the US for both Darzalex and Darzalex FasPro. Also the Brand Impact surveys are highly encouraging..
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23/3 15:49 af E L |
Can you tell us if Daratumumab list prices were raised again for 2021 and if that raise was the same for IV and Faspro? Can you indicate how Dara sales started in the first months of 2021?
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23/3 15:49 af Jan Van de Winkel |
It is too early to comment on individual products. We are excited about the potential to add at least one more program beyond epco and TV into late-stage clinical development.
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23/3 15:48 af GeorgeBest |
Do you see possibilities to start phase 3 trials for GEN1046 this year?
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23/3 15:48 af Jan Van de Winkel |
We are very enthusiastic about DuoHexaBody-CD37 and believe this unique therapeutic antibody candidate can potentially be used in combination with epco as well as several other products for therapy of B-Cell cancers.
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23/3 15:46 af GeorgeBest |
Do you see GEN3009 as mainly a combination partner for epco, or do you also see it having its own life in monotherapy and as combination partner for other products?
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23/3 15:46 af Jan Van de Winkel |
We are currently evaluating DuoBody PD-L1x4-1BB in multiple expansion cohorts involving six different solid tumors and also in different lines of therapy. We anticipate data for a number of cohorts in 2021.
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23/3 15:45 af GeorgeBest |
Where do you see possibilities for GEN1046. Only in later lines of treatment or also in first line?
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23/3 15:44 af Jan Van de Winkel |
We definitely intend to position epcoritamab over the different lines of therapy for multiple B-Cell malignancies. I cannot comment on Roche's positioning of Glofi.
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23/3 15:43 af GeorgeBest |
As I understand you aim to position epco also for first line treatment. Latest information around Glofitamab seems to indicate Roche positions Glofitamab as a nicheproduct for later lines. Do you agree on this assumption?
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23/3 15:43 af Jan Van de Winkel |
We don't know the Roche plans for their products and continue to believe that epcoritamab has best in class characteristics with its subcutaneous delivery as one of the key differentiators.
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23/3 15:42 af GeorgeBest |
Do you expect Roche to develope a subcu formulation for Glofitamab?
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23/3 15:42 af Jan Van de Winkel |
Genmab only stands to its commitment to limit dilution from our warrant programs as promised to the market. The primary target for investments is our product pipeline.
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23/3 15:40 af Jan Van de Winkel |
we don't give guidance over different years and base the projections on operating expenses on the development of our product pipeline. We anticipate 2021 to be a very important year for a number of products. It will also be the year where both our DuoBody platform and HexaBody platform will get a lot of attention on the biotech innovation ecosystem.
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23/3 15:37 af Jan Van de Winkel |
Biotech is about potential and our increased investment high quality differentiated pipeline is a testament to our ability to create new medicines that can impact the lives of patients. In our history we have never had a better pipeline and our guided operating expense should be seen as a sign of strength.
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23/3 15:35 af E L |
There has been a lot of debate in this chat on the size of the 2021 operating expenses, where some are really happy that you are speeding up investments, while others are scared that you are taking on too much risk and think that you should have at least signalled these high costs earlier to prevent a miss on analyst guidance. Can you respond to those critics and explain why you believe this is the best way forward?
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23/3 15:35 af Jan Van de Winkel |
With that, let us open up for questions from all of you.
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23/3 15:34 af Jan Van de Winkel |
Putting all this together, we’re still planning for substantial operating income in 2021 in a range of 1 to 2 billion Kroner..
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23/3 15:34 af Jan Van de Winkel |
For operating expenses, we expect to be in a range of 5.5 to 5.8 billion kroner. This step-up in investment is fully in line with our strategy and our focus on creating long-term value..
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