Q&A Genmab 2020-05-11

	11/5 13:23 af Helge Larsen/PI-redaktør	This session starts at 15 o'clock.
	11/5 14:59 af Helge Larsen/PI-redaktør	Hi Jan van de Winkel. Are you online?
	11/5 14:59 af Jan Van de Winkel	Hello. We are just fixing an issue with sound - two minutes and we are ready.
	11/5 15:00 af Helge Larsen/PI-redaktør	Fine. :-)
	11/5 15:03 af Jan Van de Winkel	Hello all. Thank you for inviting us back to share some insight to our Q1 2020 results. We look forward to your inspirational questions.
	11/5 15:03 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.
	11/5 15:03 af Helge Larsen/PI-redaktør	Can you give us a short-term update on key figures and important events in Q1?
	11/5 15:04 af Jan Van de Winkel	We are delighted to be here and can't wait to see you questions.
	11/5 15:04 af Jan Van de Winkel	A few Development highlights:
	11/5 15:04 af Jan Van de Winkel	We dosed the first patient with DuoHexaBody-CD37, and we submitted IND and CTAs for DuoBody-CD3x5T4. Further, we initiated an expansion cohort in the DuoBody-PD-L1x4-1BB (jointly developed with BioNTech). Finally, complete dose escalation data and efficacy results from the phase I/II study of epcoritamab have been accepted for presentation at ASCO 29-31 May 2020.
	11/5 15:05 af Jan Van de Winkel	On our partnered products, we have seen progress with the approval and impressive launch of Tepezza. The Ofatumumab applications for relapsing MS have been accepted by the US and EU regulatory authorities and we anticipate potential approval in this indication in the 1st half of this year. Finally, Janssen’s amivantamab, developed using the DuoBody technology and consisting of 100% Genmab developed antibody building blocks, has received a Breakthrough Therapy Designation from the FDA
	11/5 15:05 af Jan Van de Winkel	– the very first such designation for a DuoBody product candidate.
	11/5 15:05 af Jan Van de Winkel	For DARZALEX, we reported USD 937 million in net sales by J&J during the first quarter, an increase of 49% over Q1 last year, resulting in DKK 775 million in royalties. Given the challenging coronavirus situation we are very pleased with DARZALEX’s performance in Q1
	11/5 15:05 af Jan Van de Winkel	Darzalex received an additional approval in EU based on the CASSIOPEIA study and finally, following the end of the quarter, we were very pleased to see the approval in the US of the subcutaneous formulation of daratumumab, Darzalex FasPro. This approval leads to a significantly reduced treatment time from hours to just 3-5 minutes with similar efficacy and safety profile and fewer Infusion-related reactions.
	11/5 15:05 af Jan Van de Winkel	Financial highlights:
	11/5 15:06 af Jan Van de Winkel	In Q1, Revenue came in at DKK892 million an increase of 51% compared to Q1 2019..
	11/5 15:06 af Jan Van de Winkel	Total expenses in Q1 were DKK 821 million, with 87% being R&D and 13% G&A..
	11/5 15:06 af Jan Van de Winkel	Operating income was DKK 71 million compared to an operating loss of DKK 26 million in the first quarter of 2019 primarily driven by higher revenue. .
	11/5 15:06 af Jan Van de Winkel	That brings us to the net result where we reported net income of nearly 269 million Kroner, compared to 72 million in the same period last year..
	11/5 15:06 af Jan Van de Winkel	At Genmab we are not immune to the current COVID-19 crisis and we are seeing some headwind, but we expect this to be temporary and our guidance as issued in February is maintained.
	11/5 15:07 af Plimsoller	Congratulations on the SC approval. Does that mean that Dara again will be tried in solids, or is it still the plan to await the isatuximab trial readout?
	11/5 15:08 af Jan Van de Winkel	Our first priority is to roll out the SC formulation in MM. We have also a Phase 3 ongoing amyloidosis..
	11/5 15:09 af Jan Van de Winkel	as it relates to solid cancers, JnJ is awaiting data from isatuximab by Sanofi before testing SC dara in solid cancers...
	11/5 15:10 af Jan Van de Winkel	1 option is for Genmab to potentially evaluate HexaBody-CD38 in solid tumors, but that will only be considered after we establish safety and efficacy in MM..

	11/5 15:10 af Jan Van de Winkel	so some time from now.
	11/5 15:11 af bibob	Mr Winkel. Do you see the bottleneck will disappear rapidly when Dara sc is on track. ??
	11/5 15:12 af Jan Van de Winkel	Yes, my expectation is that many MM patients will consider treatment with Darzalex FasPro, especially in times of Corona Virus Disease.
	11/5 15:12 af bibob	Mr Winkel. The Dara sale in US vs ROW has been a little low for some time. Do you see Dara sc will change that. ?
	11/5 15:13 af Jan Van de Winkel	Overall we believe Darzalax FasPro will further build sales in the US as well as in ROW.
	11/5 15:13 af Bulder	Will home administration by a nurse of Faspro be possible already from first injection given need for observation?
	11/5 15:14 af Jan Van de Winkel	It will be up to the treating physicians to determine how Darzalex FasPro can best be brought to patients.
	11/5 15:14 af Bulder	Does the approval of dara sc in the US cover potential compendia listing of DRVd in the asct-setting (Griffin)?
	11/5 15:15 af Jan Van de Winkel	We have a very broad label as of May 8th in the NCCN guidelines for Darzalex FasPro (broader than in the FDA label)...
	11/5 15:16 af Jan Van de Winkel	We currently don't have an NCCN listing for Dara VRD, albeit that the GRIFFIN study has been published recently, so we will have to await next steps.
	11/5 15:17 af E L	We learned from JNJ’s earnings that JNJ-6372 -the DuoBody EGFR-cMET in non-small cell lung cancer- will be submitted at the end of this year. We had already heard it has breakthrough designation and JNJ mentioned it earlier as a potential blockbuster. According to Halozyme it is also a potential SC candidate. Can you add any more colour on this?
	11/5 15:18 af Jan Van de Winkel	JnJ 372 (amivantamab) is a very exciting DuoBody entirely build up from Genmab created antibody building blocks with highly encouraging clinical data in lung cancer patients..
	11/5 15:18 af Jan Van de Winkel	we eagerly look forward to the data on the ongoing phase 2 study and potential regulatory filing..
	11/5 15:19 af Jan Van de Winkel	It will be up to Janssen to decide whether they want to develop a SC formulation of amivantamab.
	11/5 15:19 af GeorgeBest	Have there been any new issues with liver toxicity in patients treated with HexaBody-DR5/DR5 since the clinical hold was liftet last year?
	11/5 15:20 af Jan Van de Winkel	We are still in the process of optimizing dosing and dose frequency with HexaBody DR5/DR5 and hope to be able to present clinical data in the 2nd half of 2020.
	11/5 15:20 af GeorgeBest	Do you know why Roche put their cd3/cd20 on hold? Corona virus or toxicity proble ms?
	11/5 15:21 af Jan Van de Winkel	We are aware of holds on some of the large phase 3 studies by Roche and think that this is related to complications with recruitment in the COVID-19 era, we have no other information on Roche's motivation to stop recruitment.
	11/5 15:22 af GeorgeBest	Where do you see the biggist potential for Epcoritamab. Blood cancer or solid tumors?
	11/5 15:23 af Jan Van de Winkel	Clearly epcoritmab is optimally positioned for treatment of blood cancers and that will be the first focus of us and a potential partner for this super exciting program.
	11/5 15:23 af GeorgeBest	Now that Roche have put their cd3/cd20 on hold, is there then a change that Epcoritamab not only will be "best in class" but also "first in class"?
	11/5 15:24 af Jan Van de Winkel	We currently estimate that the Roche lead programme may still be arriving at the market before epcoritamab. We are working very hard to minimize the distance between the two market introductions.
	11/5 15:24 af E L	Last month we saw the start of a DuoHexaBody-CD37 trial for B-cell NHL, at the same time it was featured in a prominent article in Blood Cancer Journal. Could you say something about the potential you see for this new antibody?
	11/5 15:26 af Jan Van de Winkel	DuoHexaBody-CD37 is a highly potent antibody for treatment of B Cell cancers as based on the preclinical work. We first need to show safety of this antibody therapeutic before we cansay more on the potential of this product candidate.
	11/5 15:27 af GeorgeBest	Is there a change to see Andromeda presented at ASCO as a late breaker?
	11/5 15:27 af Jan Van de Winkel	At this point we have not seen data from ANDROMEDA.