Q&A Genmab 2019-03-04

	4/3 15:57 af Helge Larsen/PI-redaktør	This session starts at 16 o'clock.
	4/3 16:57 af Jan Van de Winkel	Hello all. We are ready for your questions. Jan van de Winkel and David Eatwell here..
	4/3 16:57 af Helge Larsen/PI-redaktør	Great.
	4/3 16:58 af Helge Larsen/PI-redaktør	Good afternoon Jan van de Winkel and Peter Eatwell. Welcome to Q&A here on ProInvestor.com. We are very happy to have you ba ck here and ready to answer questions from our investors.
	4/3 17:00 af Helge Larsen/PI-redaktør	First of all let me congratulate on the great results for 2018 . Can you give us a short-term update on key figures and important events?
	4/3 17:00 af Jan Van de Winkel	Financial highlights: For the sixth year in a row we are profitable, with our Revenue, Operating Result and Net Result in 2018 at the highest level in the history of Genmab…
	4/3 17:00 af Jan Van de Winkel	Revenue DKK 3,025 mio up DKK 660 mio. or 28%...
	4/3 17:00 af Jan Van de Winkel	Expenses DKK 1,645 mio up DKK 624 mio or 61% (or DKK 456 mio. / 49% after reimbursement from partners)…
	4/3 17:01 af Jan Van de Winkel	Operating result DKK 1,380 mio, up DKK 36 mio or 3% and net result DKK 1,472 mio, up DKK 368 mio or 33%...
	4/3 17:01 af Jan Van de Winkel	Key 2018 achievements: Darzalex approved in US & Europe in combination with bortezomib, melphalan and prednisone (VMP) in frontline multiple myeloma (MM)…
	4/3 17:01 af Jan Van de Winkel	Split dosing regimen approved in Europe and in the US [early 2019]…
	4/3 17:01 af Jan Van de Winkel	Reported positive topline results from the MAIA and CASSIOPEIA studies…
	4/3 17:01 af Jan Van de Winkel	DARZALEX became a double blockbuster, with net sales by Janssen exceeding the USD 2 billion sales mark during 2018, triggering a USD 75 million milestone payment to Genmab…
	4/3 17:02 af Jan Van de Winkel	Our collaboration with Seattle Genetics continues to be fruitful, with four new studies started or announced last year. One of these studies, called innovaTV 204 is a potential Phase II registration study in recurrent or metastatic cervical cancer…
	4/3 17:02 af Jan Van de Winkel	We progressed the Phase I/II study of enapotamab vedotin in solid tumors into the expansion phase, and treated the first patients in the first-in-human studies of HexaBody-DR5/DR5 in solid tumors and DuoBody-CD3xCD20 in B-cell malignancies…
	4/3 17:02 af Jan Van de Winkel	Finally, we introduced an exciting new technology, HexElect, and a strategic collaboration with Immatics..
	4/3 17:03 af Helge Larsen/PI-redaktør	The investors and stock market appreciates Genmab's guidance for 2019. What do you expect in key figures and important events this year?
	4/3 17:04 af Jan Van de Winkel	Revenue 4.6 bn; OPEX 2.6 bn leading to a new record operating income of DKK 2 bn. Revenue driven by continued success of DARZALEX...
	4/3 17:06 af Jan Van de Winkel	For this year we expect a speedy approval of DARZALEX in frontline MM based on the MAIA data and we look forward to other data with Daratumumab, the GRIFFIN study, the CANDOR study and of course the full data of the COLUMBA study, where we hit both of the primary endpoints last week...
	4/3 17:07 af Jan Van de Winkel	In the second half of this year we expect meaningful clinical data for all of our four proprietary clinical programs
	4/3 17:07 af Jan Van de Winkel	...
	4/3 17:07 af Jan Van de Winkel	Finally, we expect to file INDs/CTAs for three more proprietary programs in 2019..
	4/3 17:07 af Budweis	Congratulations with the 20th anniversary! What a journey. Last week you participated in an video interview with the danish newspaper Børsen. Can you tell us a little more about the consultant report that have been made calculating the potential dara sale north of 10bn$. What is the peaksale estimate and how is it split between US and ROW?
	4/3 17:09 af Jan Van de Winkel	I can confirm that the numbers from the latest survey among European and US physicians on the use of DARZALEX in multiple lines of therapy of MM north of 10 bn USD. As this is a model, we do not want to provide further colour...

	4/3 17:10 af Jan Van de Winkel	The covering analysts for Genmab currently estimate peak sales north of 9.5 bn USD for MM..
	4/3 17:10 af Darvin	Genmab says the potential for Darzalex is greater than $ 10 billion. Can you tell us whether Genmab finds this likely within the current indications, including Amyloidosis, or whether you are calculating the use of Darzalex in other cancers?
	4/3 17:11 af Jan Van de Winkel	The numbers we are referring to were solely for MM. Currently there are also studies ongoing in Amyloidosis, NKTCL lymphoma and ALL so there could be further upside is such studies would read out positively..
	4/3 17:11 af troldmanden	Could you try and shed some light on the clinical cost What ballpark figure can do you calculate per person for the early phase 1/2 trials and later phase 2 and 3 trials. And as a bonus question what amount do you believe J&J have used so fare on Dare?
	4/3 17:14 af Jan Van de Winkel	On our top ten projects we will spend approximately 1.3 bn DKK in 2019. These will be split between our top 2 projects of about 800 m DKK and the next 8 at about 500 m DKK. So on the early stage projects, we will spending about 60 m DKK per project...
	4/3 17:14 af Jan Van de Winkel	In general, we estimate that per patient costs for clinical trials amount to about 1 million DKK per patient..
	4/3 17:15 af Relax	Genmab has considerably expanded the cost of developing the pipeline for 2019! Can investors expect these costs to accelerate further over the coming years? If so, is their an estimate of how much will be invested before results can be expected?
	4/3 17:16 af Jan Van de Winkel	At present, Janssen has over 95 clinical studies with Daratumamb, including over 14.500 patiens..
	4/3 17:16 af kkjoel	Mr Eatwell - given the 2685M DKK outlook on 2019 from a $3B Darza turnover at the 6 USD/DKK rate - and all our previos knowledge of the royalty-tiers - I tried to do the math (as you suggested on a few CCs;-). Would it be possible for you to confirm this full range (which hits spot-on for all the given numbers): 0-750 12%, 750-1500 13%, 1500-2000 16%, 2000-3000 18%, 3000- 20%?
	4/3 17:16 af Jan Van de Winkel	It depends how the pipeline develops and which projects move to later stage development. In addition it will depend on our partnering strategy..
	4/3 17:17 af Jan Van de Winkel	We can confirm that the numbers you quote are correct..
	4/3 17:18 af Bulder	Did Janssen achieve Priority Review for Alcyone in Japan? If so, is it also 6 months?
	4/3 17:19 af Jan Van de Winkel	We do anticipate approval in the second half of 2019..
	4/3 17:19 af JStudsgaard	After skin cancer, breast cancer is the most common cancer diagnosed in women. About AXL, you write that it contributes to tumor progression in breast cancer among others. Why are you not including Breast cancer in your trials with HuMax-AXL-ADC ?
	4/3 17:20 af Jan Van de Winkel	We currently E.V. for solid tumors that are known to over-express AXL. In the second half of this year, we expect meaningful data from all expansion cohorts and may want to broaden the range of tumors for testing E.V..
	4/3 17:21 af Bulder	Can data from the Columba study be the basis for approval in all treatment lines in MM, or do we have to await the sc combo study MMY2040?
	4/3 17:21 af Jan Van de Winkel	The COLUMBA study is the only non inferiority PHIII that would be needed to obtain a label for SC daratumumab...
	4/3 17:23 af Jan Van de Winkel	In order to obtain a broader label, we would also need to obtain safety data from the PLEIADES study which is evaluating 3 cohorts of patients DARA + RD, DARA + VMP and DARA + VRD. If this study reads out positively, we expect to obtain a broad label for SC DARA..
	4/3 17:23 af Thomas	In the Capital markets day in 2016 we heard that potential partners were queueing up interested in doing deals on the Hexabody platform. Why havent we seen any deals?
	4/3 17:24 af Jan Van de Winkel	We are currently actively evaluating the HexaBody platform for a number of targets, some of these in collaboration with (future) partners...
	4/3 17:25 af Jan Van de Winkel	As Genmab intends to hold on to 50% or more of the product rights, the negotiations of contracts and future partnerships is more complicated and lengthy..
	4/3 17:25 af Thomas	Do you expect to partner up on Enapotamab?
	4/3 17:26 af Jan Van de Winkel	It is too early to say whether we want to partner E.V. as we do not have robust clinical data at present...
	4/3 17:27 af Jan Van de Winkel	As communicated to the market, we feel that a targeted smaller market could be handled by Genmab without a partner. If the therapeutic would be active in larger market, a partnership makes best sense..
	4/3 17:28 af Sukkeralf	Mab Discovery was recently bought by BioNTech - does that impact your deal with Mab Discovery? Are the BioNTech/Genmab DuoBody partnership still active besides the two 4-1BB BsAbs?
	4/3 17:28 af Jan Van de Winkel	The acquisition of MAB Discovery has no impact on some of the work performed by this company for Genmab...