Q&A Genmab 2020-08-26
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
26/8 15:40 af Jan Van de Winkel |
This is a question for Novartis. The label for Kesimpta is broad and very very clean as it relates to safety aspects.
| |
26/8 15:39 af Bulder |
It has lately in MS-news been described that treatment with Ocrevus can result in loss of vaccinal immunity for RRMS-pts. Is this also the case for Kesimpta?
| |
26/8 15:39 af Jan Van de Winkel |
We are still in the process of fine tuning dose frequency and dose levels and expect to have the data available this year to make decisions on next steps.
| |
26/8 15:38 af Bulder |
How far have you come with the hexabody dr5/dr5 study?
| |
26/8 15:38 af Jan Van de Winkel |
Currently for DKd only the IV formulation is approved. We expect PLEIADES trial to deliver data for a SubCu label.
| |
26/8 15:36 af Bulder |
Does the approval of sc dara in the us also cover the newly approval of DKd?
| |
26/8 15:36 af Jan Van de Winkel |
Excitingly, we are well on track to file an IND in 2020.
| |
26/8 15:36 af Jan Van de Winkel |
We believe the future of HexaBody-CD38 looks bright. as pioneers in the CD38 field, we have never seen an Antibody product more potent than HexaBody- CD38, and cannot wait to see it in the clinic..
| |
26/8 15:34 af Bulder |
What does the JnJ aquisition of Momenta mean for the future of Hexabody-cd38? Momenta has the anti-cd38 SIF-body in preclinical developement.
| |
26/8 15:34 af Jan Van de Winkel |
Yes, absolutely. Both these AB's are currently tested in combination with daratumumab in MM.
| |
26/8 15:33 af Bulder |
Could teclistamab and/or talquetamab be combined with dara to treat MM?
| |
26/8 15:33 af Jan Van de Winkel |
Based on the robust progress we made year-to-date, our strong financial foundation and our world-class expertise and capabilities, I am confident that we will continue to be successful in the remainder of the year. And now, let us open up for your questions.
| |
26/8 15:33 af Jan Van de Winkel |
Guidance updated to be a revenue of DKK 9.25-9.85 billion. Operating expenses maintained at DKK 3.85-3.95 billion and an operating income of DKK 5.35-5.95 billion..
| |
26/8 15:33 af Jan Van de Winkel |
Total expenses in the first half of 2020 were 1.78 billion Kroner, with 84% being R&D and 16% G&A. Operating income was 4.57 billion Kroner compared to 111 million in the first half of 2019, driven by higher revenue. That brings us to our net income of 3.6 billion Kroner..
| |
26/8 15:32 af Jan Van de Winkel |
Financial highlights:
In the first six months of the year, Revenue came in at 6.34 billion Danish Kroner an increase of nearly 5 billion Kroner compared to the first half of 2019. The increase was primarily driven by the upfront payment from AbbVie and higher DARZALEX royalties..
| |
26/8 15:32 af Jan Van de Winkel |
Our pipeline is progressing rapidly and is currently stronger than ever. We are working particularly hard on accelerating our potential “next winners”, epcoritamab and DuoBody PD-L1X4-1BB. We look forward to sharing updated data from both of these programs later this year..
| |
26/8 15:31 af Jan Van de Winkel |
DARZALEX also remains an important factor in our success. Another major 2020 milestone was achieved in the second quarter with the subcutaneous formulation of DARZALEX, called DARZALEX FASPRO in the US, approval in both the US and in Europe..
| |
26/8 15:31 af Jan Van de Winkel |
This collaboration sets us on a path to accelerate, broaden and maximize the development of some of our promising bispecific antibody therapies, including epcoritamab, with the ultimate goal to bring differentiated new potential therapies to cancer patients much faster..
| |
26/8 15:31 af Jan Van de Winkel |
Our landmark AbbVie collaboration was one of the most anticipated events of the year for Genmab. Genmab and AbbVie will be equal partners, working together to jointly make all strategy, clinical development and commercialization decisions for three Genmab bispecific antibody therapies – epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4 – as well as potential novel differentiated cancer therapies created under a discovery research collaboration..
| |
26/8 15:31 af Jan Van de Winkel |
Along with our partner Seattle Genetics, we announced that the innovaTV 204 trial of tisotumab vedotin for patients with recurrent or metastatic cervical cancer had met its primary endpoint, with a 24% confirmed ORR and a median duration of response of 8.3 months. We very much look forward to discussing these results with the FDA and the potential for the first BLA submission for one of our proprietary therapeutic candidates, which would be an important milestone in our company’s history..
| |
26/8 15:30 af Jan Van de Winkel |
Development highlights:
Two key events have occurred since we last talked to you at ProInvestor on our first quarter results; we reported very favorable topline results for tisotumab vedotin in cervical cancer and of course we announced our broad, foundational oncology collaboration with AbbVie..
| |
26/8 15:30 af Helge Larsen/PI-redaktør |
Can you give us the financial highlights and the key achievements in H1?
| |
26/8 15:30 af Jan Van de Winkel |
We can't wait to get started
| |
26/8 15:30 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.
| |
| ||
26/8 15:29 af Jan Van de Winkel |
Hello all,
Thank you for having us back to interact with you all. We look forward to an energizing session with lots of smart and inspirational questions.
| |
26/8 15:29 af Jan Van de Winkel |
Yes
| |
26/8 15:29 af Helge Larsen/PI-redaktør |
Hi Jan van de Winkel. Are you online?
| |
26/8 12:09 af Helge Larsen/PI-redaktør |
Denne session starter kl. 16,30.
|