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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER
8/11 16:38
af Jan Van de Winkel
We will also hold our 2019 RnD update and ASH data review on December 9 and very much look forward to that event as well.
8/11 16:38
af Jan Van de Winkel
Excitingly, this bispecific antibody seems to be much better than a key competitor, Emicizumab...
8/11 16:37
af Jan Van de Winkel
There will be three presentations by Novo Nordisk on an exciting next generation bispecific antibody called MIM-8 created with Genmab's DuoBody technology...
8/11 16:36
af Jan Van de Winkel
34 presentations on Daratumumab of which 7 oral presentations, 2 DuoBody CD3xCD20 presentations and a presentation on our next-gen CD38 program HexaBody CD38 ...
8/11 16:35
af Jan Van de Winkel
ASH will be a key event in early December where Genmab will have 37 presentations on Genmab created products...
8/11 16:35
af Helge Larsen/PI-redaktør
What do you expect regarding key figures and important events in Q4?
8/11 16:34
af Jan Van de Winkel
Finally, sales of DARZALEX continue to meet expectations, with net sales reaching USD 2,168 million in the first nine months of 2019, resulting in DKK 2,033 million in royalties to Genmab.
8/11 16:34
af Jan Van de Winkel
Over the past few months, Genmab also reported two separate sets of positive topline results for daratumumab. The Phase II GRIFFIN and the Phase III CANDOR study, sponsored by Amgen, both met their primary endpoint...
8/11 16:34
af Jan Van de Winkel
DARZALEX momentum continued apace with new approvals in multiple myeloma. These include an approval in the U.S. based on the CASSIOPEIA study, approval in Japan based on the ALCYONE study, and the first ever DARZALEX approval in China, as monotherapy for patients with relapsed or refractory multiple myeloma...
8/11 16:34
af Jan Van de Winkel
The potential to further expand our preclinical pipeline into new and exciting areas also increased as we entered into strategic collaborations with Tempus and with BliNK Biomedical...
8/11 16:34
af Jan Van de Winkel
Also, in September, the preliminary data from the non-small cell lung cancer expansion cohort of the Phase I/II study of enapotamab vedotin in solid tumors was featured in an oral presentation at the International Association for the Study of Lung Cancer 2019 World Conference on Lung Cancer.. .
8/11 16:34
af Jan Van de Winkel
We also saw progress with Genmab’s proprietary products during the past quarter. In September, the first patient was dosed in the first-in-human Phase I/II trial of DuoBody-CD40x4-1BB in solid tumors.. .
8/11 16:33
af Jan Van de Winkel
Another partnered product moving towards potential approval is teprotumumab. The U.S. FDA granted Priority Review to the BLA submitted by Horizon Therapeutics for teprotumumab in the treatment of active thyroid eye disease, assigning a PDUFA target date of March 8, 2020. If the BLA is approved, it would make teprotumumab the third Genmab-created product to reach the market...
8/11 16:33
af Jan Van de Winkel
Based on this data, our partner for ofatumumab, Novartis, has stated that they will initiate submissions to health authorities by the end of this year, signifying a possible turning point for ofatumumab...
8/11 16:33
af Jan Van de Winkel
The highly anticipated Phase III data for subcutaneous ofatumumab in relapsing multiple sclerosis was presented at ECTRIMS in September. Both ASCLEPIOS trials met the primary endpoints with ofatumumab showing a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate, demonstrating superiority versus teriflunomide...
8/11 16:32
af Jan Van de Winkel
This event is significant not only because it was the second largest US IPO ever by a biotechnology company, with total gross proceeds of USD 582M, but because of how it positions Genmab for future success. This dual-listing provides Genmab with far greater visibility in the US, allowing us to share Genmab’s compelling story with a wider group of thought leaders including academia and the financial community...
8/11 16:32
af Jan Van de Winkel
In July Genmab officially became a dual-listed company, trading on both the Nasdaq Copenhagen stock exchange and the Nasdaq Global select Market in the U.S...
8/11 16:32
af Jan Van de Winkel
Key Events:
8/11 16:32
af Jan Van de Winkel
We anticipate our operating expense base will be 2.75Bn DKK, which is consistent with the previous guidance. Taken together the result is an operating income of 2.35Bn DKK, an increase of 300 million DKK compared to the previous guidance...
8/11 16:31
af Jan Van de Winkel
We now expect our 2019 revenue to be DKK 5.1Bn. This 300 million DKK increase, compared to previous guidance, is mainly due to positive foreign exchange movements between the USD and DKK resulting in increased milestone income and royalties on sales of DARZALEX...
8/11 16:31
af Jan Van de Winkel
Operating income of 462M DKK for the first nine months of 2019, compared to 659M DKK in the same period in 2018. The decrease of 197M DKK, or 30%, was driven by higher operating expenses and the one-off Novartis payment in Q1 2018...
8/11 16:31
af Jan Van de Winkel
Total expenses in the first nine months of 2019 were 1,943M DKK, an increase of 813M, or 72%, which was driven by the advancement of our clinical products including tisotumab vedotin and enapotamab vedotin as well as our other pipeline products. As planned, we also increased the number of employees to support our pipeline expansion...
8/11 16:31
af Jan Van de Winkel
Revenue for the period came in at 2,405M DKK, an increase of 616M, or 34%, compared to the first nine months of 2018…
8/11 16:31
af Jan Van de Winkel
Financials:
8/11 16:30
af Helge Larsen/PI-redaktør
First of all let me congratulate on the great results for the first nine months in 2019. Can you give us a short-term update on key figures and important events?
8/11 16:29
af Helge Larsen/PI-redaktør
Good afternoon Jan van de Winkel to our Q&A here on ProInvestor.com. We are very ha ppy to have you back here and ready to answer questions from our investors.
8/11 16:29
af Helge Larsen/PI-redaktør
Great.
8/11 16:29
af Jan Van de Winkel
Yes and ready to go!
8/11 16:29
af Helge Larsen/PI-redaktør
Jan. Are you online?
8/11 16:29
af Jan Van de Winkel
Hello all. Good to be back at ProInvestor. We look forward to your questions. Fire away.
8/11 15:45
af Helge Larsen/PI-redaktør
Denne Q&A starter kl. 16,30.
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