So hello and welcome to the Genmab conference call to discuss the company's financial results for the 1st 9 months of 2020. With me today to present these results is our CFO, Anthony Pagano and for the Q and A, we will also welcome our Chief Development Officer, Jurett Klimovsky and our Chief Operating Officer, Anthony Monsigny. Let's move to slide 2. As already said, we will be making forward looking statements, so please keep that in mind as we go through this call. Let's move to Slide 3.
We have seen significant advances in our and our partners' pipelines throughout 2020 and the Q3 was no exception. On a single day in August, the U. S. FDA granted approvals to Novartis for Casynta in relapsing MS and to Janssen for the 8 multiple myeloma indication for DARZALEX. The Cosimpta approval was highly anticipated and we were very pleased that RMS patients in the U.
S. Had this convenient treatment option approved nearly a month earlier than expected. I'm also very pleased to note the progress in our proprietary pipeline where we have at least 50% ownership of potential therapies. In July, we dosed the 1st patient in an expansion cohort for abcuritumab. As you may have seen this morning, abcuritumab will be featured in an oral presentation at ASH.
In August, we saw the start of the 1st in human trial of dual body CD35T4. And as you may recall, we are developing both aptaritumab and CD3534 as part of our broad oncology collaboration with AbbVie. It is also my pleasure to announce that in October, we submitted the IND for HexaBody CD38, the 2nd IND genmab submitted this year. We're also very much looking forward to the presentation of the first clinical data for dual body PDL-onefour-1BB, a major milestone in our collaboration with BioNTech at the SITC Annual Meeting next week. In September, we presented key data for tisotumab vedotin, which we are developing with CGM from the Phase 2 innovative 204 trial during a late breaking oral presentation at ESMO.
Based on these results, we together with Cgen look forward to submitting a BLA to the FDA under the accelerated approval pathway. Recently, we entered into a joint commercialization agreement with Cgen. Genmab will co promote tisotumab vedotin in the U. S. And we will lead commercial operational activities and book sales in Japan, while CGM will lead operational commercial activities in the U.
S, Europe and China with a fifty-fifty cost and profit split in those markets. In any other market, Seagen will be responsible for commercializing tisotumab vedotin and Genmab will receive royalties based on a percentage of aggregate net sales ranging from the mid teens to the mid-20s. The companies will continue to practice of joint decision making on the worldwide development and commercialization strategy for tislelizotamab vedotin. I would also like to highlight recent developments in the very productive dual body research and license agreement with Janssen. A 7th dual body molecule has now entered the clinic and there are 2 Phase 3 trials by Janssen for amivantamab in non small cell lung cancer listed on ct.gov.
In late October, clinicaltrials.gov was updated at an expanded access program to provide amifantumab to patients with metastatic non small cell lung cancer who have epidermal growth factor receptor exon 20 insertion mutations and whose disease has progressed during and after current standard of care platinum based chemotherapy. Excitingly, Janssen has announced that they are planning a U. S. Filing for amivantumab. If this occurs, it will be the 1st investigational therapy using our proprietary dual body technology platform submitted for approval in the U.
S, a major milestone for this technology and for Genmab. And we are very excited that ASH has selected 2 Janssen products that were created using our dual body bispecific platform for all presentation at our annual meeting. Turning to DARZALEX. As I mentioned, the FDA broadened the label for the 8th time with an approval based on the Phase 3 CANDOR study. Janssen has now also submitted an SPLA seeking approval in AL amyloidosis.
And if this is approved, it would become the first indication for DARZALEX outside of multiple myeloma. Recently, we announced data from the second part of the Phase III CASSIOPEIA study, which met the primary endpoint of progression free survival at a pre planned interim analysis. Following the positive data from the first part of CASSIOPEIA, we are very pleased to see this benefit in the Part 2 of this study. Finally, we reported $2,937,000,000 in net sales by J and J during the 1st 9 months of the year, an increase of 35% over the 1st 9 months of 2019, resulting in about DKK2.9 billion in royalties. On September 22, Genmab commenced a binding arbitration of 2 matters under the license agreement with Janssen.
We refer you to the details mentioned in the announcement and we cannot provide additional information until the arbitration is concluded. Telmab intends to vigorously protect its rights under the agreement. However, the outcome of any arbitration proceeding is inherently uncertain. I'm pleased to now turn over the call to Anthony Perhano to present our detailed financial results for the 1st 9 months of 2020. Anthony, go ahead.
Thanks, Jan. Let's move to Slide 4. Before I get into the results and the guidance, I'm going to spend a moment reiterating our overarching financial framework. First off, let's look at our revenue profile. On the left, you can see the component parts of our current and future recurring revenue streams.
It starts with DARZALEX. And here, we are looking forward to continued growth and expansion. And you can also see COSIMTA and TEPEZZA. We're excited about the launch of COSIMTA in RMS that occurred in August and the Tepesza launch continues to be strong. Next, on to R and D investment shown on the right.
And this is one of the areas where our collaboration with AbbVie makes a real difference. We'll continue to be focused and disciplined in our approach. And as we told you before, we're going to continue to expand and accelerate our potential winners. But clearly, the cash from AbbVie and the fact that we're sharing the investment in the existing clinical programs on a fifty-fifty basis means we'll be able to do more and faster. Now stepping back, what continues to stand out for me from this overall framework is that Genmab remains a resilient business with a very high quality product pipeline and great growth prospects.
Now let's move to DARZALEX on Slide 5. Here we saw continued strong performance in the 3rd quarter with the 1st single quarter with sales over $1,000,000,000 You can see that in the chart on the left. Overall, DARZALEX worldwide sales grew by 35% year over year. That's net sales of $2,900,000,000 which translates to DKK2,900,000,000 in royalty income for Genmab. For Q3, we believe this shows a normalizing of the sales following the softness we saw in Q2 due to COVID-nineteen.
Additionally, we're pleased that sales include continued uptake of the subcu formulation, which was approved in the Q2. As I've just highlighted, Q3 was strong. And so far in Q4, we like what we're seeing in the U. S. But we do need to bear in mind the context of the unfortunate reemergence of COVID-nineteen.
Even so, we continue to expect that DARZALEX sales will be in the range of 3.9 dollars to $4,200,000,000 for 2020. So DARZALEX continues to be on a clear path to market leadership in multiple myeloma and remains a key driver of our revenue as you can see on Slide 6. Looking at the graph on the left, you can see that there were 3 significant contributors to the increase in revenue. First, as we noted in Q2, we recognized 90% of the $750,000,000 upfront payment from AbbVie. Now clearly, that's a one off contribution.
And second, DARZALEX royalty grew 43% compared to the 1st 9 months of 2019. Finally, you see other. Most of that DKK 399,000,000 comes from 2 main items. 1st, the peso royalties. Here, we've seen a really strong start.
It's still early days, but we see this as a very promising launch. And second, the payment from Novartis as a result of Novartis' plan to transition Arxera to an oncology access program for CLL patients in the U. S. Now if we take DARZALEX and TEPEZZA together, we're really pleased to have seen recurring revenues grow by 51% in the 1st 9 months of 2020. As well as increasing revenues, we also increased investment in our pipeline, in our team and in our capabilities as you can see on the next slide.
On the graph on the left, you can see the major drivers of our increased investment in the 1st 9 months of the year. In total, operating expenses increased by DKK 698,000,000, which was driven by the accelerated investment in our product portfolio, including the advancement of both eptiridumab and dual body PD L1-four-1BBB. We've also spent more on expanding our very talented team. We've continued to hire key team members to support our growing product pipeline and we've continued to build our commercial capabilities. With the upfront from the AbbVie collaboration, our revenue growth significantly outpaced the higher investment levels driving DKK 5,400,000,000 of operating income.
Now having looked at the individual parts, let's look at our financials as a whole on Slide 8. Here you will see a P and L summary. In the 1st 9 months of the year, revenue came in at DKK 8,100,000,000, an increase of nearly DKK 5,700,000,000 compared to the 1st 9 months of 2019. The increase was primarily driven by the upfront payment from AbbVie and higher DARZALEX royalties. Total expenses were DKK 2,600,000,000 with 84% being R and D and 16% G and A.
Operating income, as I noted, was DKK 5,400,000,000 compared to DKK 462,000,000 in the 1st 9 months of 2019, driven by higher revenue. And that brings us to our net income of DKK 4,200,000,000. So an extremely strong 2020 so far despite the COVID-nineteen pandemic, which brings me to our guidance on Slide 9. We are maintaining our 2020 guidance. In summary, we expect our revenue to be in the range of DKK 9,250,000,000 to DKK 9,850,000,000.
This is still driven by the upfront payment from AbbVie and the continued growth of DARZALEX complemented by the strong launch of Tepeso. We continue to anticipate our 2020 OpEx to be in the range of DKK3.85 billion to DKK3.95 billion. Putting this together, we're planning for substantial operating income in a range of DKK 5,350,000,000 to DKK 5,950,000,000. Now I will move to my final slide, Slide 10. In conclusion, I just want to take a moment to reflect on our business and financial position.
We have a very strong foundation, even stronger following our collaboration with AbbVie. Especially important in today's environment, we've got a robust balance sheet, dollars 2,700,000,000 of cash at the end of the quarter and no debt. We have great recurring revenues and they're growing. And we're using those revenues to invest in a really focused and disciplined way. We're investing in our highly innovative and differentiated product pipeline as well as in the team and capabilities to deliver it, all driving towards our 2025 vision.
Now, I'll turn it back over to Jan.
Thanks, Anthony. Let's move to Slide 11. 2020 has been an incredibly successful year for Genmab. Due to the drive and determination of our team, we have already hit over half of our key goals and I'm confident that over the final quarter of this year, we will continue to make progress against our priorities. That said, the target we set for ourselves for this year were extremely ambitious.
And as you will have noted here, we are no longer anticipating additional solid tumor data for tisotumab vedotin in 2020. One goal we will meet very soon is, as I mentioned, the presentation of the preliminary clinical data for dual body PD L1-four-1BB at SITC next week. We look forward to being able to walk you through that data among other topics during our Capital Markets Day next Friday, November 13. We are furthermore very excited to inform you that our abstract for dual body PD L1-four-1BB has been selected to be presented and discussed with selected media outlets at the SITC virtual press conference next Monday on November 9. We are also anticipating a very exciting ASH this year.
We will hold a virtual 2020 ASH data review meeting following ASH on December 8. At this event, we will discuss the data from some of the well over 40 accepted presentations on Genmab created antibody programs, including many that were accepted for oral presentation and details about this event have been released about an hour ago and can be found on our website. So let's move to slide 12. That ends our presentation of Genmab's 1st 9 months of 2020 financial results. Now operator, please open the call for questions.
Session. We now have your first question. It's coming from the line of Wimal Kapadia from Bernstein. Please go ahead. Your line is now open.
Great. Thank you very much
for taking my questions. Wimal Kapadia from Bernstein. So Jan, I have to ask about the EPCO ASH abstract that's just come up. Clearly very strong data, particularly at the high dose. So first, I just wanted to get your thoughts on the extent of the deepening responses with time for the product that you have seen.
So just trying to get a sense of how the complete response could evolve with greater duration given the OOR is already 100% of the high dose. And then just tied to that, Jan, you previously talked about an earlier filing for the product in select indications. Given the emerging data we are seeing, can you provide any additional color on these indications and timelines? Then my second question is just on tellequitamab and the GPRC5D target. Again, the early ASH data looks quite encouraging in a sick population.
But I'm interested to hear your thoughts on the IV versus the subcu dosing for the product and just some of the safety your thoughts on safety given some of the CRS rates look quite high. Does that kind of limit the optionality of the product? Thank you.
Thanks, Wimal, for the questions. I will definitely turn the first question over to Judith. But let me first take one aspect of that earlier filing. We definitely see possibilities, Wimal, but I think we have to first present to you the detailed data and then give you further color at that moment. So we're going to park that.
And as it relates to your second question, Wimal, these are Janssen programs. We are not onto the details of the dalcretamab and teclistamab. So I'm not able to comment on the toxicity profile and on the IV versus the subcu profile of these molecules. But I think you need to ask Janssen for that. But I will ask you to maybe give a bit more color on the APCO data.
And I can tell you that we cannot wait Wimal to present the data at ASH. I think this will be a fantastic ASH this year for Tienmab. And as I said before, the more data we see with aporitumab, the more happy we get with the data. I think we have really a potential best in class molecule here. And having said that, maybe Judith over to you to see whether you can say anything further on duration of response.
Yes. Thank you, Jens. So just to answer the question, the first, the card of the abstract is July. But for the actual poster, you will see a little bit more data. As disclosed in the abstract, by the time of the cut, the median follow-up was 8.3 months and 25 patients were still ongoing.
And I think that with this, I give you a signal that 25 patients were still ongoing. And if you look at the data again at the table in above 48 milligrams for the DLBCL from 7 patients, the ORR was 100%, CR 28%, 72% PRs and those patients were ongoing. So and if they're same thing above 12 and the cat is arbitrary, but in order to have like a little number of patients within 12, 3 patients, 100 percent ORR, 33% PR and 66 percent CR, 63% PR. So we expect duration of follow-up is 8 months, but you need to appreciate that most of the patients who are enrolled early in low dose cohorts.
Great. Thank you very much.
Thanks, Jusser. Thanks, Wimal, for the questions.
Thank you. Your next question comes from the line of Peter Verdult from Citi. Please go ahead. Your line is now open.
Thank you. Pete Verdold, Citi. Jan, you did on the ASH abstracts, great to see the CRs for EPCO and the data from the myeloma bispecific programs. Just thinking ahead to see next week, is it too greedy or early to hope that we might see similar efficacy signals in the PD L1, four-1BB data to be presented next week. I realize you're not going to say anything in detail, but if you could just sketch in broad terms what we might expect to see over and above the SITC abstract, that will be helpful.
And then secondly, Antony, to better understand why guidance unchanged, especially when we can all see how strong the DARZALEX and TEPETTA trends are. Is it just simply conservatism given the macro backdrop? Is there the J and J royalty spat, OpEx phasing or something else that's driving you to be to maintain the guidance? And if I could, just a clarification on this arbitration process. I realize you're going to make no forward looking statements.
But factually, J and J have withheld something in Q2 and Q3. I know it relates to the Halozyme royalty they believe you need to contribute to, which is 5%. So factually speaking, did they deduct 1% or 2.5% of FASPRO sales from the royalty they paid during Q2 and Q3? So it's a backward looking question. Thank you.
Thanks, Peter. I will definitely leave the last two questions to Anthony. For the first one, I think we can say very minimally because we are on barcodes basically Peter. As you will understand by SITC, you will definitely see a very nice data set from the dose escalation with the PD L1-four 100B bispecific antibody. And yes, I think the fact that it has been selected for presentation and highlighting at the press conference probably already tells enough at this point.
I want to leave it with that Peter and then hand over to Anthony for the financial questions on the guidance and on the potential offset for the Halozyme royalties by Janssen.
Yes, great. Thanks, Peter. So I think looking at where we're at, starting with revenue on a year to date Q3 basis, just sort of summarizing, we're at DKK 8,100,000,000 of revenue, which means we need just DKK 1,200,000,000 to get to the lower end of our guidance and DKK 1,800,000,000 to get towards the upper end. Putting this into context, our total revenue for Q3 was $1,700,000,000 but this did include around $200,000,000 of one time items primarily related to the payment from Novartis that I mentioned in my opening remarks. And Peter, you put the nail on the head or hit the nail on the head.
It was expected key contributors in Q4 will continue to be DARZALEX and TEPEZZA. Looking at Dara after a strong Q1, we did see some softness in Q2 due to COVID-nineteen. As you've seen earlier in October when the numbers came out, this was followed by an exceptionally strong Q3, whereas I mentioned earlier, we sold the 1st single quarter with over $1,000,000,000 sales. In fact, sales reached nearly $1,100,000,000 which is a 22% quarter over quarter growth compared to Q2.
And there
are a couple of factors that sort of think about then where we're at. As I mentioned, there's significant quarter over quarter growth. So we need to sort of think about any potential intra quarter patient dynamics. Secondly, you referred to the macro environment, we need to put this in the context of the unfortunate reemergence of COVID-nineteen. And as I mentioned in my opening remarks, I did talk about what we're seeing in the U.
S. Being strong here in the early parts of Q4, but our visibility ex U. S. Is rather limited. Now in terms of the arbitration, maybe a comment in this regard regarding DARZALEX and the related royalties.
Given the ongoing arbitration and Janssen starting to make deductions in Q2, we do need to follow the accounting rules and we have started to approve for this as a reduction to our royalty revenue. I can't get into the specifics of exactly how we're doing that or exactly as to what Janssen is sort of withholding from us. If I put all this together, we're really pleased with the progress of Dara and remain confident in our full year guidance range of $3,900,000,000 to $4,200,000,000 as well as our total revenue range of $9,300,000,000 to 9.9, We think that's the right place to be as we sort of exit Q3 and get into Q4. And I'll be brief in terms of OpEx. Here we see a number of sort of significant increase items in Q4, primarily related to DUOBAL and PDL-one hundred and forty one BB and EFCO in terms of existing and potentially new trials as well as some significant CMC activities.
Thank you.
Thanks, Peter. Thanks, Anthony.
Thank you. Your next question comes from the line of Kennen MacKay from RBC Capital Markets. Please go ahead. Your line is now open.
Congrats on the quarter and stellar 2020 so far. Another question on the PD L1-four-one CB. I think this combination is maybe one of the most exciting within the sort of immunotherapy landscape beyond PD-one, beyond the initial checkpoint. I was just wondering, given evaluating single arm trials has been a challenge in the past. So how you're thinking about the discriminating the efficacy, the contribution of 401BB versus PD L1 here and really what we should be looking for as we look at this data coming up at SITC?
Thank you and congrats again.
Thanks, Kennen for the kind words and congratulations. PD L-one hundred and forty one-1 hundred B, I'm going to hand that over to Judith and then ask Judith to give you some color and maybe add to that. Judith?
Yes. Thank you, Jan. So for as Jan alluded, we will have ample time to discuss this at the Capital Market Day and the actual poster and the actual data to give you a hint on how we think about the contribution of each one of the components. As you have seen, we are running several expansion cohorts, parallel arms. And each of the expansion cohorts have will teach us where we stand because we chose indications where breast cancer or head and neck cancer or urothelial as examples.
So these opportunities will give us an indirect comparison or where or what 1046 can do visavis what is very consistently reported for PD-1s PD L1s. Is it clear?
Judith, maybe just to elaborate on that a little bit, that sort of those indications span both sort of immunologically cold as well as hot tumors, obviously, post PD-one treatment in earlier lines of therapy. Just wondering where yourself and the team are sort of most excited about the potential for this bispecific? Is it turning cold tumors hot, so to speak, or much more so in reactivating tumors that previously were immune responsive? Thanks again.
Okay. I would say all of the above, option A and B. So as you see in the expansions, we are enrolling patients that are naive to checkpoint inhibitors in those tumors where the activity for PD-1s or PD-one is modest or low. And in addition, we are enrolling like 5 tumor types that failed PD-1s, PD L1s. So obviously, after PD-1s, PD L1s is kind of low hanging fruit.
And we will collect those data and the totality of the data will guide us on future steps. With regards to hot or cold, I don't know what definition are you using. But for the conditional activation of 4 1 BD, there is some level of PD L1 that we need. And we are collecting a very comprehensive biomarkers to understand better how this could or could not play a role for this agent?
Thanks, Judith. Thanks, Kennen. Next week, there will be a lot more Kennen. So it will be PDL-one hundred and forty one will be weak next week. All right.
Operator, we can move to another question.
Thank you. Your next question comes from the line of Trung Huang. Please go ahead. Your line is now open.
Hi, guys. Thanks for taking my questions. It's Trung from Credit Suisse. So firstly, just
on tisotumab vedotin.
You saw the
pivotal data at ESMO. You over 50% of people having ocular adverse events. So they were mild to moderate. But are you putting in your plans an expectation for a REMS program or any type of eye care education program to avoid these ocular events turning severe? And then if you could just confirm when you expect to file?
And then secondly, you're on the cusp of transitioning from this R and D company to a commercial company, and that starts with tisotumab. But perhaps can you talk about the level of investments that you're going to need to next year? And when does those expenses start to ramp? So any help there would be welcome. Thanks very much.
Thanks, Trung. And I'm going to definitely hand over to Judith for the first one. For the filing, I can tell you that you should stay tuned. I mean, we're very busy preparing that. And then I will ask Anthony to give you some color on the investments needed to really make the move to a fully fledged commercial company.
But Judith, maybe you can start with the Ocala events and then on the potential REMS program?
Thank you. So first, we are encouraged by the data and variance of the assets and actively working on the BLA. At this point, we don't disclose timelines, but stay assured that our commitment to patients with cervical cancer is to file as soon as the BLA is ready. With regard to the ocular toxicity, as highlighted by Doctor. Ocmin in the ESMO discussion with the management plan that we included in the protocol that includes a corticoid throat and a mask and those modifications is absolutely manageable and very different what is known from MMIS.
As to whether we will go with educational rent, these are regulatory details that we are not disclosing publicly. So I didn't answer.
Thanks, Judith. And then maybe Anthony Pagano, a bit of color for Trung on the steps in the coming time. I don't know how much we are willing to disclose, but maybe you can provide some perspective here for Trung.
Yes. Happy to do so Trung. Yes. I mean for me it really does start with our financial framework of being focused and disciplined. So in this context, we've been thoughtful about how we've made investments in building out our early commercial capabilities over the last several years.
And that would have accelerated here more recently. And also more recently, we've begun to further build out leadership position in the U. S. And of course, really excited now to have Anthony Mancini on board as well. In terms of this focus, the U.
S. And Japan, these are the two markets where we plan to focus our initial activity. Now following the positive data, we're starting to further build out our capabilities and all of this was an eye for the potential TSo launch, but also thinking about the broader opportunities that are in front of us. And maybe just quickly thinking about our investments generally. We'll continue to be focused and disciplined as we invest in our business and with growth opportunities that are in front of us.
And really I've talked about this in the past. As we think about being focused and disciplined, there are really two sides to this point.
On the
one hand, about discipline, about derisking investments that we can and making tough decisions along the way. Now the other side of that point, we're thinking about focus, it starts with our focus strategy, we've been executing again for some time. It's also about how we allocate capital. And for 2020, I'm very deliberate about focusing our investment dollars and our growth towards key programs and how we're thinking about really moving our business forward. And we should commit to really as we move forward we'll likewise be focused and disciplined and provide relevant sort of thought process to why we're making certain investments.
That's probably where I'm going to leave it now.
Thanks, Anthony. Thanks, Trung.
Thanks, guys.
Thank you. Your next question comes from the line of Michael Schmidt from Guggenheim. Please go ahead. Your line is now open.
Thanks for taking my questions and congrats on all the progress. Maybe another follow-up on epcaridumab. I guess now that you have more clinical data in hands and congrats on the ASH presentation. I guess what is your latest thinking around the development opportunity longer term, maybe relative to your competitors, primarily Roche and Regeneron? And where do you think the drug may have the strongest value proposition?
And another question on GEN-ten forty six, again, I know you commented around the update coming up here at SITC. I'm just wondering if we should think about this as a potential monotherapy opportunity in patients progressing or resistant to checkpoint inhibitor therapy or whether there's what type of bar efficacy bar one should think of in those settings potentially and whether there's an opportunity longer term also in earlier stage maybe patients maybe in combination with other drugs? Thanks so much.
Thanks, Michael for the questions. And I'm going to hand over both to Judith to give some color on EPCO and the value proposition and the development plan. This is expensive and very rapidly developing. You will see very soon Michael more and more trials appear on city.gov I can assure you. And then for the PD L1-four hundred and one BB maybe also a bit more color, Judith, on how to develop this as monotherapy and in combination with other drugs for different cancers.
Judith, over to you.
Yes. Thank you, Jan. Thank you, Michael. So with regard to the question for EPCO, as the data unleash, it will guide us further. But the way we see this asset visavis the others is with very, very high efficacy, very acceptable safety and convenience of the subcutaneous formulation.
And because of these characteristics, ECCO in the whole spectrum of B cell malignancies. Of course, we will go to the traditional development paradigm, which is start with a low hanging fruits and expand as we learn more in different combinations. And as Jan alluded, you will see more in coming weeks. So this is with regard to EPO. And related to other assets, cross trial comparisons are difficult, but we are very pleased with how the data is consolidating in each card and as we increase the N and the characteristics and attributes of EPCO becoming more consistent.
And I would like to flag that oloronexamab started in 2014 and the recommended Phase 2 dose, I think was declared last year or we started 2 years ago and we started the expansions already and more to come in coming weeks, months. So this is regard to EPO. So fully committed to unleash the full potential and more to come. With regard to 1046, I don't think that single agent or combinations are mutually exclusive. The way that we are exploring is we start with single agent, we define the safety profile and the efficacy bar and we assess the potential for combination in terms of A, which combination partner and these will be guided by the data that we see as single agent.
So we are thinking of both strategies and the data from the expansion cohorts will tell us, I mean, where to combine and we will explore. And there are several agents that we started a discussion that could have additivity or synergy with 1046. So more to come as we learn about the expansions and where we stand. In terms of efficacy, what is the bar as with other IO or that is important, but duration like PFS and impact on overall survival is super important and it is a characteristics of IO where you have responses, but you have long lasting stable disease, which really benefit patients. So it will be a time landmark analysis plus the traditional TCR and order.
Okay, great. Thank you so much.
Thanks Judith. Thanks Michael.
Thank you. Your next question comes from the line of Sung Jin Jiang from Bank of America. Please go ahead. Your line is now open.
Hi. Thanks for taking my questions. A couple, please. Just firstly, kicking off with DARZALEX, could you give an update as to where subcut penetration is in the U. S?
And how you're thinking about that into 2021? And then going back to the arbitration, and apologies, Anthony, if you're unable to answer this, but do we expect this to be resolved by the time of full year 2021 guide? Or should we start thinking about 2021 on a reduced royalty rate basis, where the impact could be more material if subcut to bigger percentage of DARZALEX sales? That's topic 1. Topic 2, just to go back to 41BB, I've seen a lot of comments already.
But just to clarify, are you ready to announce next steps in terms of trial expansion tumors etcetera at the Investor Day at the end of next week? I just wanted to clarify that. Thank you.
Thanks Sachin for the questions. I'm going to hand over the first one to Anthony Monsigni to give a bit more color on subcu. Then the second question to Anthony Pagano. And then 4.1 would be, I think we should park that question basically till next week, Sachin. We have a Capital Markets Day.
We have SITC and we are not willing to give you further color on that at this point. But we will definitely be more than pleased to work you over the data and I think we need to wait till next week. So maybe I can hand over to Anthony Monsigni to give a bit more color on subcu and how it is actually progressing in the U. S. Anthony?
Thanks Jan and thanks Sachin for the question. Yeah, overall we're pleased with the strong growth and share gains across lines of therapy for DARZALEX. And specifically as it relates to FastPro in the U. S, it was clearly a driver of some of the share gains that we're seeing in earlier and earlier lines. And now to give you some color, if you look at IQVIA and SINFONI data, it accounts for in the latest weekly gross sales data about 40% of U.
S. Weekly gross sales. And as it relates to market share, we're also seeing encouraging performance. I think in the latest data point and this is brand impact data from IQVIA, We saw the highest point in total frontline patient share at 12% and also the highest ever point as it relates to new frontline patient share at 16%. So we continue to believe that earlier and earlier use of DARZALEX will be driven by Faspro.
And certainly, we're continuing to hear that the convenience, the efficacy and the safety I'll pass Maybe I'll pass it to Anthony Pagano to talk about the second part of your first question.
Thanks, Anthony. Anthony Pagano, any color on offset for royalties in 2021?
Yes. Thanks, yes. Thanks, Sach. Sachin, I can really appreciate that. I wish I could help you out, but I do have to just refer you back to the details that we mentioned in the announcement around the arbitration.
And I really I can't provide any additional information until the arbitration is concluded. So unfortunately, I just have to leave it there. Okay. No worries at all.
Thank you very much.
Thanks, Asher. Thanks, Anthony.
Thank you. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Your line is now open.
Hi, thanks for taking my question. Just a couple of coke wins. If you could remind us of the FX basis for the current guidance? And then also just in the answer to the last question, you gave the update for frontline penetration for DARZALEX. So just if you wouldn't mind giving the full update across the different lines of therapy.
Thank you.
Thanks, Emily for the questions. The first one is for Anthony Paragano. The next one is for Anthony Monsigni to give you full color because we just got the brand impact data for September. Emily, we will be happy to read them out to you. Anthony Paragano?
Yes. Hi, Emily. Yes, in terms of FX, we had original assumption to begin a year of a U. S. Kroner rate of 6.5 percent and we've left that in place all year as kind of our full year assumption as we're all well aware.
We started the year off ahead of that. We've been out and fired ourselves. At least this morning was I think around 635, 637. And so we're just leaving that assumption of 6.5 unchanged. And maybe now over to Anthony Mancini to sort of talk about the market shares.
Yes. Thanks, Anthony, and thanks, Emily, for the question. Just to give you the update on market shares for total patient share, I gave you the frontline total patient share at 12%. 2nd line is up to 41%. 3rd line is now 49% and 4th line is 43%.
Thanks, Anthony.
Thank you.
Thanks, Emily. Let's move on to the next because we have still a number of people asking questions I believe. Next one?
Yes. Your next question comes from the line of Jonathan Chang from SVB. Please go ahead. Your line is now open.
Hey, guys. This is David Ruch on for Jonathan. Congratulations on the progress and we appreciate you taking our questions. First question on tisotumab vedotin. Could you talk a little bit about the potential to expand into additional indications beyond cervical cancer and the timing of data disclosure for these additional tumor types?
Thanks, Dave for the questions. I will hand it over to Judith. We are now testing tislelomafedotin out in 5 other solid tumors. Judith can give you some further color on which tumors there are and potential timing. Judith?
Yes. Thank you. So as Jan alluded, we are testing in ovarian cancer and in 4 tumors in the based on the presence that were selected based on the presence of the expression of tissue factor, head and neck, 1x, 1x, small cell lung cancer, pancreas and colorectal cancer. These two studies are operationalized by our partner CIGEN. We are actively enrolling patients.
And at this point, we cannot commit on a particular time lines. And we will see and we expect like by next year, we'll have more clarity on when these cohorts will have enough data to be presented. Now in terms of tislelomar, vivoting, the way I think about it and the data on cervical cancer is super favorable, but it can be think about as a proof of mechanism of action where other tumor types with that expressed tissue factor might respond as well. And this is why we are looking forward as well to have more data on each one of these tumors to understand the potential.
Thanks, Judith. Thanks, Dave.
Thank you. I just wanted to follow-up for enapotumab vedotin. Could you talk a little bit more about the data disclosure we might get over the remainder of this year? And how you're thinking about next steps for that program? And that's it for me.
Thank you.
So I can be brief. Dave, we haven't updated you on that yet. This year, we will have the data to allow for decisions on next steps and that's where I want to leave it at. So busy times ahead in the coming 2 months.
Got it. Thank you.
All right.
Thank you. Your next question comes from the line of Greg Suvannavejh from Goldman Sachs. Please go ahead. Your line is now open.
Yes. Hey, it's Greg Silvanovich, Goldman. Thank you for taking my questions and congrats on the progress in the quarter. I've got 2, please. Just as a follow-up to an earlier question on the litigation, just wanted to and I might have missed it, any expectations on the timing of that resolution, and how we should be thinking about that, whether it's year end or first half of next year or sometime next year?
And then my follow-up, just on the uptake of FAST PRO. I'm just curious, if, you're seeing from a reimbursement or market access perspective, whether there are any hurdles or challenges, that might still be in place that is perhaps currently still holding back the potential uptake of that product? Thank you.
Thanks, Craig for the questions. I will definitely pass the second one over to Anthony Mumsini. But let me start with the arbitration. As you and I know and I said in my introductory remarks, we cannot make any further comments and the timing of any arbitration proceedings Greg is inherently uncertain, so we cannot give any further color. We will do that after the arbitration is over basically.
Then we can give you all the details, but not now. And then maybe Anthony Monsigni on the potential hurdles for Fast
Pro? Yes. Thanks, Jan, and thanks, Greg, for the question. At this point in the U. S, the Janssen team has done a really, really nice job as far as removing any hurdles there.
The uptake from a or the uptake from a P and T and pathway perspectives and GPO perspective has been spot on. So there are no remaining hurdles in the U. S. And certainly in Europe, it takes time to get public reimbursement for the subcu formulation and knowing at least a couple of the major markets as is the case that there is public reimbursement achieved for the subcu formulation in some of the EU major markets already. So it's going very, very well.
Thanks, Anthony. Thanks, Greg.
Thank you. Your next question comes from the line of Asthika Gounodhika from Trust Securities. Please go ahead. Your line is now open.
Hi, guys. AstraZeneca from Trust Securities. Thanks for taking my questions. Yang, I believe a couple of quarters ago, you mentioned that with Faspro, J and J was training hospital staff at home administration as a workaround to the shutdowns that were happening with COVID-nineteen. I'm wondering now with COVID-nineteen underway, has your partner broadened this out to more across in the U.
S. And also maybe into Europe to do this kind of at home administration to help sustain volumes there of Faspro? And then on PD-onefour-1BB, if I may, I'm excited for PD-onefour-1BB week next week, but I was wondering if you guys could help me prep with some of my immunology homework here. You know what you know about your own asset, but we've also seen some of the data for Roche's FAB four-1BB plus at ESMO where we didn't see activity in PD-one failed patients and didn't see much activity on TNBC. Reading between the lines in your abstract, you seem to have maybe a better profile here.
So maybe on a high level, in terms of targeting, dosing, other engineering aspects, could you maybe walk us through why yours is better than Roche's PABP-four and VB approach? Thanks.
Thanks, Astika, for the questions. And I will start with the first one. I can tell you that what we said before is that actually bigger cancer centers in the U. S. Were training nurses to visit patients at home for FOSPRO treatments.
And I don't know whether this actually has been broadened in the 2nd wave of coronavirus. So I'm going to ask Anthony Monsigni in a sec to give his perspective on that because I'm simply unaware of that Asthika. But as it relates to PD L1-four forty one BB, I will let Judith give you a bit more color there. But I think the big difference is I think is our dual body platform, because we actually can create thousands of candidates of bispecifics and then empirically select the best one. And that is why we are so unusually effective now in actually creating these very well working bispecifics against different targets.
You've seen it at APCO, more data at ASH. You've seen it with the eclistamab, with our createmab from Janssen also with more data at ASH. And you will hopefully see it next week with PDL-fourteen 100 and would be at SITC from us Asthika. So I think the secret is really that we can actually create thousands of candidates with the robots and then actually empirically select the one based on very strict criteria, which is working the best. And I've given already the example of Novo Nordisk who created more than 30,000 bispecifics with the dual body technology to FISH OUT 1, which is 15 fold better than HEMLIBRA for hemophilia.
So I think this is now a recurrent team. And I will let I'll leave it up to Judith to give you some further color on the specific PD-onefour-1BB combination versus the Roche four-1BB combination. But let's first start with Anthony Monsini and see whether Anthony knows of any further activities in training nurses or other hospital personnel in actually treating patients with DARZALEX FASTPRO at home. Anthony?
Thanks Jan and thanks Dastika for the question. As you know, FASTPRO is approved for HCP administration. And although some teaching centers did, at the onset of COVID initially start to do some at home administration, There aren't any plans for Janssen to do that in the near future. What's really good though is that based on the inherent advantages of Faspro in that it provides a 3 to 5 minute injection, the same efficacy as IV and safety benefits that are actually 2 thirds fewer infusion reactions than IV. And the Janssen team has trained extensively nursing staff in oncology offices around the U.
S, the sense is that they'll be much better positioned here in the second wave to do the in office administrations quickly without exposure as was potentially a concern the first time around. So hopefully that answers your question.
Thanks, Anthony. Let's move over to Jure to see whether you want to give a bit more color to Asthika on the Roche compound versus the PD-onefour-1BB or do you want to park that to next week Jure?
No, I can give like a general answer because the concept are totally different. So for the FAS four-1BB, the FAS helps to globalize the four-one BB PD L1-four-1 BB is a different concept. It's not only the localization based on the presence of PD L1, but you have it while signaling the inhibition of the PD L1, PD L1 axis plus the 4 1BB in the context of the cell cell synopsis that acts like as a zipper. So I think that these biologically is different than the concept of the SARS for 1BB.
Thanks very much Judith. I think you So, I'm still
signaling the yes, yes. I don't know if you're
We need to probably park the seal Astika, but more to come next week for sure.
Thanks guys.
Thank you.
Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead. Your line is now open.
Hi. Yes, thanks for squeezing me in. A few. Firstly, and I think I missed this at the start, but I wonder if you could just outline the commercial deals for the CGen that you've agreed to. I got cut off, and I'm afraid I'm missing the explanation of the CGen collaboration.
Secondly then, just on the arbitration, I appreciate details of scamp, but can you confirm whether or not the first arbitration claim is related in any way to the second arbitration claim, either reduction in royalties and the extension of the patent? Or are these 2 completely separate arbitration issues? And then just thirdly, curious the amount of time that was spent, I guess, in the slide I've not sort of seen before on the strong financial position. I mean, it's obviously very clear that there is. Does this reflect increased appetite within Genmab to pursue business development and perhaps bringing in assets, obviously, as you shift towards a commercial entity?
Or is there really no change internally in your appetite and desire to perhaps pursue those sorts of deals and the money very much Thanks, Peter, for the questions. So
Thanks Peter for the questions. So the first question I'm going to pass over to Anthony Monsigni who can also give you a bit of color as he's heading the BD activities now on the strategy going forward. Let me handle the second question Peter on the arbitration. These are 2 related items basically both focused on the subcu formulation of daratumumab. So they are clearly related, but clearly 2 different questions we have, which are both going to be part now at the arbitration judges to take a decision on.
I think I should leave it with that and then ask Anthony Mancini to explain the Cgen commercial agreement, which we've recently put into place, which I did mention Peter at the beginning of the remarks, but Anthony is happy to repeat them for you for sure. Anthony?
Thanks Jan and thanks Peter for the question. Just to recap some of the detail that Jan covered earlier. We're really pleased, by the way, just with the amendments to the joint commercialization agreement with Seagen. We think it's a win win for both Seagen and Genmab. But from a development and commercialization strategy perspective, we will continue to work together with Seagen.
From a operations or economics perspective in the major markets, which are the U. S, the EU, China and Japan, they'll be fifty-fifty cost and profit split. And as Jan mentioned, in other markets outside of those, there will be royalty territories, whereby Genmab will receive royalties on net sales in the mid teens and mid-20s. From an operational perspective, Genmab will be the exclusive commercialization party and book sales in Japan and Cgen will book sales and lead commercial operational activity in other territories. As it relates to the U.
S, Genmab and Seagen will co promote TB in the U. S. With each party contributing 50% of medical representatives as well as MSLs. And from a clinical operational perspective, Seagen will be the operational development lead for future TB studies. So overall, we really leverage Seagen's presence in one presence in one of our key markets with 50% of field resources in the U.
S. And continue to lead exclusively in Japan. So we're really pleased with that. Just to answer the other part of your question, Peter, with respect to business development, corporate development, Clearly, we're going to continue to look at opportunities for partnerships in a disciplined and focused way. And we'll keep you posted as that evolves.
But we're definitely going to continue, first, to work towards becoming a fully integrated biotech company, to attract the best talent in order to do that and also in parallel with the opportunity partnership and complement their fixed costs. With that,
I'll pass. Thanks, Anthony. And then Peter Morte come next week at the Capital Markets Day on Friday 13th. That's great. Thank you.
Thanks.
Thank you. Our last question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead. Your line is now open.
Hi, all. This is Connor on for Matthew. Thanks for squeezing us in. So cognizant that a bunch of questions have been asked on 401BB, but can you just give us the highlights on your expectations for the program after the data at SITC? And then maybe, you mentioned that you're going to discuss the plans at the Capital Markets Day as well.
But do you across both monotherapy and the other expansion cohorts, do you see a need for more dose escalation before you maybe move it into the next phases? And then just quickly, this may be similar to the actual program, but on DR5, do you think you have an active therapeutic window? And what do you see as your expectations for that asset before the end of the year? Thank you.
Thank you very much for the question. So I can I think be very brief on the PDL-onefour-one hundred BBM barcode? So we cannot give you any further color on the data. We have to wait until at least Monday, the press meeting from SITC. So and then the second question related to that I think you can handle as well.
We know the recommended Phase 2 dose. So we are not going to do further dose escalation. We know exactly which dose we want to use for the expansion cohort and for the further development. And then for DR5, DR5, more updates this year. I cannot give it at this time, but we are definitely still exploring different doses and dose frequencies.
We've a very active program. And even in the coronavirus era, the patients are coming into the trial. So also no further news at this time. And in few of the time, I think I'm going to give it back to the operator here.
We have no further questions.
All right. So thank you all for calling in today to discuss Genmab's financial results for the 1st 9 months of 2020. If you are not able to get to your question, please reach out to our Investor Relations team. They are ready to answer the questions and address the issues that we haven't gotten to. So hope that you will all stay safe, remain healthy and very much look forward to speaking with you again soon, hopefully next week, if not before.
Thank you.