Q&A Genmab 2019-11-08

	8/11 16:45 af Helge Larsen/PI-redaktør	Denne Q&A starter kl. 16,30.
	8/11 17:29 af Jan Van de Winkel	Hello all. Good to be back at ProInvestor. We look forward to your questions. Fire away.
	8/11 17:29 af Helge Larsen/PI-redaktør	Jan. Are you online?
	8/11 17:29 af Jan Van de Winkel	Yes and ready to go!
	8/11 17:29 af Helge Larsen/PI-redaktør	Great.
	8/11 17:29 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 17:30 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 17:31 af Jan Van de Winkel	Financials:
	8/11 17:31 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 17:31 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 17:31 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 17:31 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 17:32 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 17:32 af Jan Van de Winkel	Key Events:
	8/11 17:32 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 17:32 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 17:33 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 17:33 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 17:33 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 17:34 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 17:34 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 17:34 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 17:34 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 17:34 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 17:34 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 17:35 af Helge Larsen/PI-redaktør	What do you expect regarding key figures and important events in Q4?
	8/11 17:35 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 17:36 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 17:37 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 17:38 af Jan Van de Winkel	Excitingly, this bispecific antibody seems to be much better than a key competitor, Emicizumab...
	8/11 17:38 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 17:39 af Relax	Dear JvW it is good to hear You are full of energy. Can you tell us what the most difficult challenges for Genmab will be for 2020?
	8/11 17:40 af Jan Van de Winkel	At the end of this year Genmab has an amazing 7 proprietary programs and we are currently anticipating to accelerate one or two of these programs in 2020. On top of that, we intend to bring new programs in to the clinic in 2020 and the challenge will be to make the right decisions on which programs to accelerate and which to terminate or put on the shelves.
	8/11 17:40 af nohope	Does doctors and hospitals in US have an economic incentive to continue using IV Dara instead of sc Dara ?
	8/11 17:41 af Jan Van de Winkel	To our knowledge, they do not, but in the end the local healthcare system will dictate the availability of treatment options to patients.
	8/11 17:42 af Bulder	What is the future for dara in solid cancers, now that Sanofi has dropped isatuximab in prostate cancer and nsclc?
	8/11 17:43 af Jan Van de Winkel	Sanofi is still evaliuating Isatuximab in combination with Atezolizumab in a number of solid tumors, so we eagerly await the clinical data from the ongoing study before determining next steps for Dara in potential treatment of solid cancers.
	8/11 17:43 af Bulder	Is dara in RA still an option?
	8/11 17:45 af Jan Van de Winkel	Janssen is currently evaluating Daratumumab in a number of disease settings outside of MM including blood cancers, NKT cell lymphoma, Amyloidosis, Alzheimers, and this list may well grow in the future.
	8/11 17:45 af E L	Can you give us your comment on the early Enapotamab vedotin data that was released at the WCLC early September? Do you still think screening for AXL expression could improve results?
	8/11 17:47 af Jan Van de Winkel	We are currently very actively studying biomarkers. One of which is expression of AXL, but also a number of other biomarkers. We get a better and better data set and insight into which patients are optimally responding to Enapotamab Vedotin. Next year we anticipate to present data of a number of expansion cohorts in the current clinical study.
	8/11 17:48 af E L	Can you tell us already what the potential royalty % is on the DuoBody pragrams with JNJ?
	8/11 17:49 af Jan Van de Winkel	The royalty percentage varies from single digits to double digits and is different between the various programs...
	8/11 17:49 af Jan Van de Winkel	Excitingly, there are six DuoBody programs evaluated in the clinic by JnJ. One of which is already moving into PH II clinical development.
	8/11 17:50 af E L	When do you think you could start the first HexaBody-CD38 trial? Do you intend to do this all alone, or will Janssen already have input from the start?
	8/11 17:50 af Jan Van de Winkel	We have publicly stated that we intend to move into the clinic with our exciting HexaBody Cd38 program in 2020...
	8/11 17:51 af Jan Van de Winkel	The initial clinical studies will be operationalized by Genmab, and we will have continuous contact with our CD38 partner Janssen.
	8/11 17:51 af E L	From what you have seen so far pre-clinical, do you think HexaBody-CD38 could potentially be a better option than Dara in a solid trial?
	8/11 17:52 af Jan Van de Winkel	We will present a very impressive preclnical data set at the ASH conference in early December showing that HexaBody CD38 can effectively kill tumors that are not sensitive to Daratumumab...
	8/11 17:53 af Jan Van de Winkel	A number of tumors will be presented in Orlando and we certainly think that HexaBody CD38 could well provide an option for treatment of solid cancers.