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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER
26/2 14:32
af troldmanden
Hi Jan I have a clarification question. You mention that Genmab will spend 825 mill DKK on CD3xCD20 and PD-L1X4-1BB in 2020. How is the split between those two programs? Are the clinical programs for both antibodies equal size this year? You also mentioned possible start of phase 3 this year with CD3XCD20. Is the cost to that included in the 825 mill dkk, or will phase 3 ONLY be started AFTER a partner is on board?
26/2 14:32
af Jan Van de Winkel
In conclusion 2020 looks like another very exciting year for Genmab.
26/2 14:32
af Jan Van de Winkel
On Daratumumab we look forward to the FDA and EMA decision on SubQ filing which we believe is going to be a game changer. We also expect data from ANDROMEDA in amyloidosis and APPOLLO trial in MM. Finally a decision from the FDA on Ofatumumab in RMS is expected in June 2020…
26/2 14:31
af Jan Van de Winkel
For 2020 from our proprietary pipeline we look forward to the data readout from the innovaTV 204 trial in H1 2020 which could potentially be pivotal and allow us to file with the FDA. Tisotumab vedotin data in other solid tumor types. Enapotamab vedotin data to support late stage development, to advance dose escalation of Hexabody-DR5/DR5, and present initial data on DuBody-PD-L1x4-1BB in H2 2020. A top priority for 2020 is establishing recommended Phase II dose and initiating expansion cohorts
26/2 14:31
af Jan Van de Winkel
And if that is not enough..
26/2 14:31
af Jan Van de Winkel
We expect our operating income to be in the range of DKK 850 – 1,250 million in 2020 compared to DKK 2,638 million in 2019…
26/2 14:31
af Jan Van de Winkel
We anticipate our 2020 operating expenses to be in the range of DKK 3,850 – 3,950 million, compared to DKK 2,728 million in 2019. The increase is driven by the advancement of our clinical programs, particularly epcoritamab (DuoBody-CD3x-CD20) and DuoBody-PD-L1x4-1BB…
26/2 14:30
af Jan Van de Winkel
We project cost reimbursement income of approximately DKK 475 million which is related to our collaborations with Seattle Genetics and BioNTech. The remainder of our revenue is approximately DKK 200 million and consists of milestones and other royalties…
26/2 14:30
af Jan Van de Winkel
Our projected revenue for 2020 primarily consists of DARZALEX royalties of DKK 4,075 – 4,475 million. Our 2020 guidance for DARZALEX royalties represents a 30% to 43% increase compared to 2019. Such royalties are based on estimated DARZALEX net sales of USD 3.9 – 4.2 billion…
26/2 14:30
af Jan Van de Winkel
We expect our 2020 revenue to be in the range of DKK 4,750 – 5,150 million, compared to DKK 5,366 million in 2019…
26/2 14:30
af Jan Van de Winkel
So on to Guidance...
26/2 14:30
af Jan Van de Winkel
Operating income was DKK 2,638 million in 2019 compared to DKK 1,380 million in 2018. The improvement of DKK 1,258 million, or 91%, was driven by higher revenue, which was partly offset by increased operating expenses.2019 year-end cash position of DKK 10,971 million, an increase of DKK 4,865 million, or 80%, from DKK 6,106 million as of December 31, 2018…
26/2 14:29
af Jan Van de Winkel
Operating expenses increased by DKK 1,083 million, or 66%, from DKK 1,645 million in 2018 to DKK 2,728 million in 2019 driven by the advancement of tisotumab vedotin and enapotamab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline…
26/2 14:29
af Jan Van de Winkel
Revenue was DKK 5,366 million in 2019 compared to DKK 3,025 million in 2018. The increase of DKK 2,341 million, or 77%, was mainly driven by higher DARZALEX royalties and milestones achieved under our daratumumab collaboration with Janssen…
26/2 14:29
af Jan Van de Winkel
Financial highlights...
26/2 14:29
af Jan Van de Winkel
Finally not to forget the U.S. IPO in July…
26/2 14:29
af Jan Van de Winkel
We filed INDs and/or CTAs for 3 new product candidates…
26/2 14:28
af Jan Van de Winkel
Much anticipated data from the Phase I/II epcoritamab (DuoBody®-CD3xCD20) clinical data dose escalation cohorts was presented at ASH…
26/2 14:28
af Jan Van de Winkel
The Phase I/II HexaBody®-DR5/DR5 trial had a partial clinical hold and initial clinical data is now anticipated in 2020…
26/2 14:28
af Jan Van de Winkel
On our innovative Pipeline, for Tisotumab we completed study enrollment of the Phase II innovaTV 204 tisotumab vedotin recurrent / metastatic cervical cancer study and expect data read out in H1 2020. We presented data from the Phase II enapotamab vedotin expansion cohort at WCLC…
26/2 14:28
af Jan Van de Winkel
On Ofatumumab Novartis completed and presented positive data on the Phase III ASCLEPIOS I & II relapsing multiple sclerosis SubQ ofatumumab studies. Application for approval have been submitted to US and European Health authorities and in the US a priority voucher has been used to reduce the approval process to 6 months…
26/2 14:28
af Jan Van de Winkel
On Daratumumab we received the positive U.S. FDA decision on Phase III MAIA multiple myeloma (MM) submission the positive U.S. FDA decision on Phase III CASSIOPEIA MM submission and finally the positive Phase III COLUMBA MM subcutaneous daratumumab safety and efficacy analysis which has been submitted to the U.S. FDA and European Medicine Agency…
26/2 14:27
af Jan Van de Winkel
Sure..
26/2 14:27
af Helge Larsen/PI-redaktør
First of all let me congratulate on the great results for 2019 . Can you give us a short-term update on key figures and important events?
26/2 14:27
af Jan Van de Winkel
Sound good, exciting times.
26/2 14:27
af Helge Larsen/PI-redaktør
Good afternoon Jan van de Winkel and Andrew Carlsen. 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.
26/2 14:26
af Jan Van de Winkel
eager to start. Please fire away. Kr Jan
26/2 14:26
af Helge Larsen/PI-redaktør
Great.
26/2 14:26
af Jan Van de Winkel
Hello All, we are very ear
26/2 12:55
af Helge Larsen/PI-redaktør
Denne session starter kl. 14,30.
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