During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipate, plans, or expects. Actual results may differ materially. For example, as a result of delayed or unsuccessful development projects. Genmab is not under an obligation to update statements regarding the future, nor to confirm such statements in relation to actual results, unless this is required by law. Please also note that Genmab may hold your personal data as indicated by you as part of our investor relation outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. Now, without further delay, I would like to hand the conference over to our speaker today, Jan van de Winkel. Please go ahead, Jan.
Hello and welcome to the Genmab conference call to discuss the company's financial results for the first half of this year. With me today to present these results is our CFO, Anthony Pagano, and we will be joined for the Q&A by our Chief Development Officer, Judith Klimovsky, and our Chief Operating Officer, Anthony Mancini. Let's move to slide two. As I already said, we will be making forward-looking statements, please keep that in mind as we go through this call. Let's move to slide three. I'm proud to say that despite the universal challenges posed by the COVID-19 pandemic, Genmab not only had a strong second quarter, but a transformative one. Two key events have occurred since we presented you with our first quarter results.
We reported very favorable top-line results for tisotumab vedotin in cervical cancer. Of course, we announced our broad foundational oncology collaboration with AbbVie. Starting with the most recent event, the highly anticipated tisotumab vedotin data in late June, we along with our partner, Seattle Genetics, announced that the innovaTV 204 trial of tisotumab vedotin for patients with recurrent or metastatic cervical cancer had met its primary endpoint with a 24% confirmed overall response rate and a median duration of response of 8.3 months. We very much look forward to discussing these results with the FDA and the potential for the first BLA submission for one of our proprietary therapeutic candidates, which would be an important milestone in our company's history. Our landmark AbbVie collaboration was also one of the most anticipated events of the year for Genmab.
Genmab and AbbVie will be equal partners, working together to jointly make all strategy, clinical development, and commercialization decisions for three Genmab bispecific antibody therapies, epcoritamab, DuoHexaBody-CD37, and DuoBody-CD3x5T4, as well as potential novel differentiated cancer therapies created under a discovery research collaboration. This collaboration sets us on a path to accelerate, broaden, and maximize the development of some of our promising bispecific antibody therapies, including epcoritamab, with the ultimate goal to bring differentiated new potential therapies much faster to cancer patients. As you can see on the slide, we have advances to report with two of these potential therapies. As we recently dosed the first patient in an expansion cohort for epcoritamab and initiated a first-in-human trial of DuoBody-CD3x5T4.
I would also like to mention that there is now a phase III trial by Janssen for amivantamab as first-line treatment in non-small cell lung cancer listed on clinicaltrials.gov. This represents the first phase III trial for a DuoBody therapy, and we very much look forward to this study being initiated. In addition, you may have seen the very impressive results from the two ASCLEPIOS phase III trials of ofatumumab in relapsing MS that were published on August 6 in the prestigious New England Journal of Medicine. Of course, DARZALEX also remains an important factor in our success. Another major 2020 milestone was achieved in the second quarter with the subcu formulation of DARZALEX, called DARZALEX FASPRO in the U.S., with approval in both the U.S. and Europe.
This is the first and only subcu CD38 antibody approved in the world, and we look forward to potential approval in Japan as well, following Janssen's submission of an NDA there in April. As a reminder, there is also potential for approval based on Amgen's CANDOR study of daratumumab in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma, with submissions by Janssen to regulatory authorities in the U.S. and Japan in Q1, as well as a submission by Amgen in Europe in the same quarter. While daratumumab may already be considered an important therapy for multiple myeloma, we continue to see the potential for further expansion in positive top-line data sets.
At the end of May, we saw the first phase III results from an indication outside of multiple myeloma, with the positive top-line data from the ANDROMEDA study of subQ daratumumab in combination with cyclophosphamide, bortezomib, and dexamethasone, or in short, CyBorDex, for patients with newly diagnosed AL amyloidosis. This was followed very recently by positive results of the phase III APOLLO study of daratumumab plus pomalidomide and dexamethasone or PomDex in relapsed or refractory multiple myeloma. This study was designed to confirm the results from the phase I EQUULEUS trial, which investigated the IV, or intravenous formulation of daratumumab in combination, the same combination, and this was the basis for an approval in the U.S. in 2017.
Finally, very excitingly, we reported $1,838 million in net sales by J&J during the first half of the year, an increase of 31% over the first half of 2019, resulting in DKK 1,652 million in royalties to Genmab. Given the challenging coronavirus situation, we are pleased with DARZALEX's performance in the first half of 2020, and we look forward to seeing the further impact of the subcu formulation as it continues to be rolled out by Janssen. I will now turn the call over to Anthony Pagano to present our detailed financial results for the first half of 2020. Anthony, go ahead.
Great. Thanks, Jan. Let's move to slide four. Before I get into the results and the guidance, I'm going to spend a moment reiterating our overarching financial framework, because I think we have materially strengthened what was already a strong foundation with our AbbVie collaboration. 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. Here we're looking forward to continued growth and expansion. You can also see ofatumumab and TEPEZZA. We're excited about the potential ofatumumab approval in RMS that is expected in September. The TEPEZZA launch is off to an exceptionally strong start. Next, onto R&D investment, shown on the right. This is one of the areas where our collaboration with AbbVie is going to make a real difference.
We'll continue to be focused and disciplined in our approach. As we've told you before, we're going to continue to expand and accelerate our potential winners. Clearly, the cash from AbbVie and the fact that we're sharing the investment in the existing clinical programs on a 50/50 basis means we'll be able to do more and faster. 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. These prospects have now been further strengthened by our collaboration with AbbVie. We see this collaboration kind of like a turbocharger towards our 2025 vision. With that intro, we can turn to slide five. If you attended our call on our transformational collaboration with AbbVie, then the information on this slide will look familiar to you.
As a reminder, here are its key elements. This is one of the largest oncology partnerships in history, with a potential total deal value of up to $3.9 billion. This includes the upfront payment of $750 million and $3.15 billion related to the achievement of additional development, regulatory, and sales milestones and opt-in payments. The collaboration includes 3 existing clinical programs. It is important to remember that we've got material commercialization rights for these potential products, which will enable us to build and increase our commercial footprint. We'll do that with an initial focus on the U.S. and Japanese markets. We've also agreed a broad research collaboration combining the R&D capabilities of both companies. This is definitely a situation where the whole is greater than the sum of the parts. We've got the potential to create 4 additional differentiated next-generation antibody product candidates.
Overall, this is a partnership that further strengthens our financial position and supports our evolution into a fully integrated biotech powerhouse, all working towards our 2025 vision. Now, let's move to DARZALEX on slide six. Here, we saw continued strong performance with only a modest COVID impact in the second quarter. You can see that in the chart on the left. As noted by J&J during their first half results call, DARZALEX saw continued strong market growth and share gains in the U.S. Overall, DARZALEX worldwide sales grew by 31% year-over-year. That's net sales of $1.84 billion, which translates to DKK 1.65 billion in royalty income for Genmab. Now, calculating the exact impact from COVID-19 is difficult, especially as we have limited insight into sales in countries outside the U.S.
As we highlighted during our first quarter call, we believe this is a short-term delay and not a fundamental disruption, and that's because of the seriousness of the disease and the need for patients to be treated, coupled with DARZALEX's strong product profile. Additionally, we expect to see continued uptake of the subcu formulation which was approved in the second quarter. For the second half of 2020, we anticipate that sales will ramp up, and we're already seeing early signs of that in the U.S. DARZALEX continues to be on a clear path to market leadership in multiple myeloma. Remains a key driver of our revenue, as you can see on slide seven. Looking at the graph on the left, you can see that there were three significant contributors to the increase in revenue in the first half.
First, we recognized nearly 90% of the $750 million upfront payment from AbbVie. Clearly, it's important to remember that that's a one-off contribution. Second, DARZALEX royalties grew more than 40% compared to the first half of 2019. Finally, you see other, and most of that $97 million comes from TEPEZZA. We've seen a really strong start here. As you may have seen, Horizon has now raised its 2020 sales guidance for TEPEZZA. Of course, it's early days, but we see this as a very promising launch. If we take DARZALEX and TEPEZZA together, we're really pleased to have seen recurring revenues grow by 47% in H1. 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 first half of the year. In total, OpEx increased by DKK 521 million, which was driven by the accelerated investment in our product portfolio, including the advancement of both epcoritamab and DuoBody-PD-L1x4-1BB. We also spent more on expanding our very talented team. We've continued to hire key team members to support our growing product pipeline, 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 4.57 billion of operating income. Having looked at the individual parts, let's look at our first half 2020 financials as a whole on slide nine. Here you will see a P&L summary.
In the first six months of the year, revenue came in at DKK 6.34 billion, an increase of nearly DKK 5 billion compared to the first half of 2019. The increase was primarily driven by the upfront payment from AbbVie and higher Darzalex royalties. Total expenses in the first half of 2020 were DKK 1.78 billion, with 84% being R&D and 16% G&A. Operating income, as I noted, was DKK 4.57 billion compared to DKK 111 million in the first half of 2019, driven by higher revenue. That brings us to our net income of DKK 3.6 billion. An extremely strong first half of 2020 despite the COVID-19 pandemic. Which brings me to our guidance on slide 10. We are updating certain aspects of our 2020 guidance previously published on June 10th.
We now expect our revenue to be in the range of DKK 9.1 billion -DKK 9.7 billion, an increase of DKK 200 million to the top end of the previous guidance. This is still driven by the upfront payment from AbbVie and the continued growth of DARZALEX, complemented by a strong start from TEPEZZA. We continue to anticipate our 2020 OpEx to be in the range of DKK 3.85 billion to DKK 3.95 billion. Putting this together, we are planning for substantial operating income in 2020 in a range of DKK 5.2 billion to DKK 5.8 billion. I will move to my final slide. Clearly, COVID-19 continues to affect everyone's lives. I think in times like this, it is useful to take a step back and reflect on our business and financial position. We have a very strong foundation, even stronger now with our collaboration with AbbVie.
Especially important in today's environment, we've got a robust balance sheet, DKK 1.9 billion of cash at the end of the second 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 12. Looking at this list, we set many ambitious goals for ourselves in 2020. Based on the robust progress we've made here to date, our strong financial foundation, and our world-class expertise and capabilities, I'm confident that we will continue to be successful in the remainder of this year. Not only will our proprietary clinical pipeline continue to advance, the many regulatory milestones on this list, and some of bits have already been met, including the spectacular launch for TEPEZZA, means that there is potential for many more patients to one day have access to, and hopefully benefit from, novel therapies created by Genmab. Let's move to slide 13. This ends our presentation of Genmab's first half 2020 financial results.
Before we take your questions, I wanted to point out one of the events we have listed on this slide here, our 2020 Capital Markets Day, taking place in November. For the safety of our attendees and speakers, the event will be virtual this year, but it will still feature a comprehensive update on our business and presentations from many of our talented and passionate team members. We will be sending a save-the-date for this event soon, and details on how you can register and listen to the webcast will be available on our website closer to the event. Now, operator, please open this call for questions.
Thank you, Jan. Ladies and gentlemen, we will now begin the question and answer session. To ask, please press star one on your telephone keypad. Will all participants limit themselves to one question each. If you have further questions, please rejoin the queue. If you wish to cancel, please press the hash key. Once again, that's star one if you wish to ask a question. Our first question is coming from the line of Peter Verdult from Citi. Please ask your question. Your line is now open.
Thank you. Peter Verdult, Citi. Jan, just one question on the data that we can expect in 2020 and 2021, particularly thinking about 41BB, PD-L1, and EPCO in terms of incremental data and phase III plans. Could you just map out for us what we can expect for those two assets data-wise and strategy-wise, in 2020 and 2021? Thank you.
Thanks, Peter, for the question. I will start with that question. Then we'll ask Judith to basically add to that. For DuoBody-PD-L1x4-1BB, we expect data in the coming months, Peter, at a conference. That will be data from the dose escalation and maybe limited data also from the expansion cohorts. For epcoritamab, we expect also data in the coming months at a key conference. That will be at the optimal dose level for EPCO in different B-cell tumors. That is for 2020. For 2021, I will ask Judith to give you some further perspective on data from these two compounds, Peter, and potentially others, like tisotumab vedotin, daratumumab, et cetera. Judith, maybe you can start on here.
Yes. Thank you, Jan. For 2020, nothing to add, but we are very well on track for those two major milestones. For 2021, we haven't mapped yet, but could be the case that we could present some more data toward the second half of 2021 on PD-L1 41BB. That's not yet mapped, so take it with a grain of salt. It's a little early for the projections, but we are on track for 2020.
Thanks, Judith. Thanks, Peter.
Thank you. Our next question comes from the line of Wimal Kapadia from Bernstein. Please ask your question. Your line is now open.
Oh, great. Thank you very much for taking my question. Wimal Kapadia from Bernstein. Just following up with Pete's question on the PD-L1 41BB. Jan, you previously mentioned six patients were treated with the product and you had seen good responses, including in PDX failures, and that you had selected a phase II dose. I just wondered if you had any incremental color to add. In particular, I appreciate that the molecule looks relatively potent from what we've seen so far. Any additional color on tolerability would be greatly appreciated. Thank you.
Thanks, Wimal, for the question. I think we have to keep very brief here until we present the data. I could tell you we have actually now treated a pretty nice number of patients, and that includes patients who are either already treated with other checkpoint blockers, Wimal, or patients with tumors which are normally not responsive to checkpoint blockers. You will probably have to wait until we present the data. We are super excited about this compound. As Anthony already mentioned in the introductory remarks, Wimal, we have stepped up this program considerably. We did for the epcoritamab program this year. We are really a company who want to invest in the potential winners.
We think that this one is a potential winner in a very exciting, expanding market, where we really need new and differentiated drugs, I think, to help cancer patients better. I think you have to await the clinical presentation in the coming months. We're very excited. That's probably why I want to keep it there.
Oh, great. Thank you very much.
Thank you.
Thank you. Our next question comes now from the line of Michael Schmidt from Guggenheim. Please ask your question. Your line is now open.
Hey, guys. Thanks for taking my questions. I just had a bigger picture questions on epcoritamab. I was just wondering, Jan, if you could maybe just share your vision for the longer-term development plan for this antibody, just given that in DLBCL, for example, it seems like it's getting a little bit more crowded with novel antibody and ADCs entering the market there in addition to CAR T. I was just curious how you think about the optimum development strategy longer term for epcoritamab.
Thanks, Michael, for the question. I will start with that answer and then will also ask Judith to complement me on that. I can tell you that we have very big plans for epcoritamab. We are continuously dosing patients. We have started dosing in the expansion cohorts, Michael. One of the ways we're seeing is that not only do we think that we have a very competitive molecule in indications like diffuse large B-cell lymphoma, follicular lymphoma, we are also having a very active molecule as it now looks at other types of B cancers, where all compounds are far less active and potent. We think that we can actually, in one way, open up new markets, basically, with this asset, which is given in a subcutaneous formulation, which we think has very distinct advantages, Michael, over the IV-delivered antibodies.
We're going to penetrate all of the lines of treatment in different B-cell tumors. We are working with our partner, AbbVie, now, to work on a very comprehensive, very aggressive plan. That's probably where I want to keep it at for the time being, but certainly new insight this year, certainly data, Michael, at key conferences. We only get more and more excited about this asset. Also in the context of the competitive landscape, we've seen some other compounds struggling from other companies recently. We think there's real opportunity here for a game-changing, differentiated, novel B-cell targeting antibody therapeutic. We believe that we have one of the potentially best in our hands here, with a very strong partner of AbbVie.
Maybe I can hand over to Judith to see whether you can shed further color without going into much detail on the development plan.
Yes. No, thank you, Jan. The vision is based on the data, and the data so far, and the data that you will see, and we're coming back, obviously, speaks to the fact that this epcoritamab can be best-in-class. It's not only the subcutaneous formulation, but also the efficacy and safety. Based on that, and leveraging on the partnership with AbbVie, we have mapped a very thorough, comprehensive plan, and you will see more in clinicaltrials.gov and when it becomes public in coming months. Stay tuned. Basically, I cannot disclose the clinical development plan because you need to understand it's a competitive space. Again, the competition encourages us because we truly believe that we have something in hand that is differentiating and better.
Thanks, Judith. Thanks, Michael, for the question.
Thank you. Your next call is now from the line of Matthew Harrison from Morgan Stanley. Please now ask your question.
Great. Good afternoon. Thanks for taking the question. I guess two from me that I just wanted to ask. One, can you just talk a little bit about HexaBody-CD38 and what you're doing internally to decide how you may move that compound forward or not? Then on tiso, now that you have the pivotal data in hand, how are you thinking about potential other indications with solid tumors, and when might we hear something about that? Thanks.
Thanks, Matt, for the questions. I'm going to hand over both to Judith, who's heading all development.
Yes.
Judith, maybe you can give your perspective on HexaBody-CD38?
Yeah. Thank you. For AXL, as we made public when we presented the data in September last year, we're in the process of optimizing the PK and understanding the biomarkers data to guide us further on potential future steps. The biomarker piece is with fresh biopsies, so it's taking a little bit longer in terms of recruitment, given the burden that is imposed on patients in the COVID era. We still are confident that by the end of the year, we'll have enough data to guide us on future steps. This is with regard to AXL. With regard to tisotumab vedotin , I want to first echo Jan on how excited we are about the data in cervical cancer.
First, the data is exciting, but in addition, we can take it as a proof of concept for tissue factor as a target for potential other tumors. As we know, a tissue factor is broadly expressed in other tumor types, and in particularly those with a very bad prognosis. This is why we started in partnership with Seagen, the Basket study and the Ovarian study. In Ovarian, we have an interesting signal even in the phase I expansion in the 30 patients there. We are looking, monitoring very closely with Seagen, the progress of the Basket study, where we enroll like 40 different tumor types, and to understand where we gather enough data of substance to get to present in public domain. It will be in the future at certain point. Stay tuned.
I cannot provide a commitment because we are monitoring it closely, but we expect to have data in the future.
Thanks, Judith. Thanks, Matthew, for the question.
Our following question comes from the line of Trung Huynh from Credit Suisse. Please go ahead.
Hi, guys. Thanks for taking my questions. I've got a couple on Dara. Can you just give us a bit more color on the progress of the subQ Dara? I know it's pretty early in the launch, but are you seeing any kind of accelerating use in Dara in the earlier lines of therapy? Are you seeing you managing to capture new patients, new DARZALEX patients, with this subQ formulation? Perhaps can you update us where you are on the penetration you have with Dara across all of the lines of therapy? Thanks very much.
Thanks, Trung, for excellent questions. I'm happy to actually hand them over to Anthony Mancini, our Head of Operations. Anthony will give you a good perspective for both of these questions. Anthony.
Hi. Thanks for the question. I think we're, as Anthony Pagano mentioned earlier, we're really pleased with the strong growth and share gains across Dara for the first half of 2020 and the FASPRO launch overall. Janssen has really done a nice job on the FASPRO launch with early rapid access in the U.S. with NCCN listing very quickly as well as all of the details, related to access like P&T and pathways lining up really well. The customer feedback on FASPRO has been very positive to date, with them replaying the fact that there's a significant benefit both to patients and offices, related to reduced chair time and short duration of in-person visits. When you have a three-to-five-minute injection, as Jan mentioned, versus a several-hour infusion, it's particularly valuable in a COVID-19 environment. We're very pleased with the overarching update.
In fact, the launch uptake of DARZALEX FASPRO is tracking at a similar pace to DARZALEX overall. We really look forward to seeing the continued positive impact of the subcu formulation in the second half. Just to comment a little bit about market shares, in terms of your question. Overarching market share in the latest data point was 24%, which is the highest overall patient share that DARZALEX has achieved to date. It's really being driven by earlier and earlier lines of usage of DARZALEX. In the frontline setting, compared to last year, we're seeing a threefold increase in frontline uptake, so 9% in the latest data point and 3% in last year at the same time. Really what's driving a large part of the gains is the second-line patient setting where DARZALEX achieved 42% overall share, and that compares to that 34% last year.
Overall, I think really strong uptake of the FASPRO, not just in the U.S. but actually around the world. We're looking forward to much more of that in the back half of the year, in order to reaffirm our guidance that Anthony referred to earlier, of $3.9 billion-$ 4.2 billion. Maybe Anthony , you can comment further on the guidance.
Yeah. Thanks. Anthony, overall, as you've heard from us today, I guess if I take a step back, right, let's start with that very, very strong product profile for DARZALEX. I think for those of you who've heard me say it before, it really is the complete package. I think looking at the 7 approved indications, now the subQ, the approval in 85 countries, reimbursement in 40 countries, now more than 130,000 patients treated. I think overall, we're very happy with the first half of the year. Obviously, we saw a little bit of softness in April, some stabilization in May, as we exit the Q2 and got into Q3, we really like what we're starting to see here, particularly in the U.S.
Thanks, Anthony. Thank you, Trung, for the questions.
Our following question comes from the line of Kennen MacKay from RBC Capital Markets. Please go ahead.
Hi. Thanks for taking the question and congrats to the team. I certainly agree with Jan that this has really been a really transformational year despite everything going on with COVID-19.
Thanks, Kennen.
My question is also on the 41BB, that phase I DuoBody. You're enrolling a number of different cancers with really varying degrees of immunologic temperature, as we say, from lung cancer to triple-negative breast cancer, which is basically the extreme of hot versus not. From the emerging trial data or biomarker data, really any other distinguishing features or differentiation, which tumors are you so far most excited about for the 41BB DuoBody?
Thanks.
I can take this one.
Yes. Please do, Judith.
Yeah. Thank you. As you alluded to, by design, phase I component of the study, it's not restrictive. We have expansion. Because of the mechanism of action, which is totally different, because it's not just the blockage of the PD-1, PD-L1 axis, but the conditional activation of 41BB, we see the opportunity broader and the potential to impact tumors that are traditionally sensitive to PD-1. Checkpoint inhibitors like PD-1, PD-Ls, and those which are difficult or nonsensitive. Part of this data will be presented at a future meeting, and you will see more by yourself. We'll present actual data, and based on that, the cohorts that were selected for the expansions are to dissect out biologically, what are the different tumors that we can go.
There you have some cohorts that focus on these sensitive tumors where they can relapse or didn't respond to, or which will be like the post-checkpoint scenario or tumors that today cannot be tackled by PD-1 and PD-L1. These cohorts will give us this data and the benchmark with current PD-1, PD-L1 inhibitors. By the end of the year, we will have this data on the dose escalation that will give you more color and the basis for the expansion.
Judith.
Thanks, Judith.
A follow-up on that. When these data are presented, I'm just trying to understand if we'll have sufficient data to really make a call on efficacy here. Is this going to just be PK/PD, or will we also see response rates and even durational response rates?
Oh, no. Okay. Yeah. It's a good point. It's a phase I dose escalation, so the objective of the study is to determine the recommended phase II dose and safety. We also collected activity, so some activity will be presented. For sure, the dose escalation, it's not designed per se for efficacy, but for safety. You will see some preliminary activity on the dose escalation. This data will be presented as any other phase I.
Thanks, Judith.
Thanks, Judith.
Thank you. Our next question comes now from the line of James Gordon from JPMorgan. Please ask your question, James. Your line is now open.
Hello. Thanks for taking the question. James Gordon from JPMorgan. My question was about CD3, CD20, Roche's mosunetuzumab. They recently got a breakthrough designation in FL. Just curious, does that change your view about how far you are in terms of time to market behind them? Are you also seeing an expedited route? Does everyone get sped up or just whoever gets there first? That was the question. If I could also just squeeze in a quick clarification as well. For 41BB, given the timing of the CMD on November 13th, is it plausible that you actually present the data at SITC, November 9th to 14th? You're actually going to have the data at the CMD, and it'll already blow up in a conference?
I think. Thanks, James, for joining. Thank you for the questions. I think both questions will go to Judith.
Yeah.
Maybe you can start with the epcoritamab, Judith.
Yeah. epcoritamab, for sure, we are aware of the data from every other asset in the CD3, CD20 space or the lymphoma space. It makes us even more excited of what we have done in two years, from 13 new to recommended phase II dose, and expansions, makes us even work harder with our partner, AbbVie, to try to take any other step to safely accelerate. This is what we are doing. We know that the space is competitive, we know the value that epcoritamab could potentially bring to patients. It doesn't change the plan. Rather, encourages us to work harder and better and with more excellence. With regard to PD-1 for 41BB, could you repeat the question?
Sure. The question is in terms of when exactly we see the data. I know you're having a Capital Markets-
Yeah.
Day, I believe, on the 13th of November, and I believe the SITC virtual conference.
No. Yes, you will see the data in the medical conference.
Got you. That could be in time for the CMP as well to be discussed.
Yes.
Okay. Thank you.
Thank you, Judith. Thanks, James. Very sharp question.
Our following question comes from the line of Emily Field from Barclays. Please go ahead.
Hi. Thanks. I was just going to try to get a little bit more precise on the last question, just because I know in prior communications this year, you talked about closing the gap with Roche. I know we-
Are you still there, Emily? I don't think we hear you. Operator, is she still there?
I think her line dropped.
I think line dropped. I think the question was closing the gap between epcoritamab and Roche's mosunetuzumab. Judith, you can say a bit more on how we think we can actually-
Yeah.
-progress epcoritamab.
No, thank you. This is what I said. We are actively working hand in hand with AbbVie to try to safely accelerate and close the gap as much as possible. We cannot quantify in months, but the fact that we started the expansion cohorts tells you that we have caught up substantially. We studied other CD3, CD20s, and we will continue in that, taking this momentum to continue accelerating.
Thanks, Judith. Then Emily, when you hear the recording, we will definitely follow up with you and see whether you have additional questions.
Yeah. Just only one thing. We never said close the gap, but our goal is to minimize the gap and to shutting the gap as much as possible in a realistic manner.
Thanks. All right, operator, I think we can take the next question.
Our following question comes from the line of Carsten from SEB. Please go ahead.
Thank you very much. Carsten Lønborg from SEB. Another question on your CMD. I was wondering whether you see the CMDs as strictly as a science event, or whether there will also be some financial outlook. What I'm trying to understand here is whether you would maybe consider updating your 2025 vision with maybe some financial targets now that you're a more mature company. Would that be something that you could discuss at this CMD? Thanks.
Hey, Carsten. Thanks for the question. What we're thinking about is, of course, the bulk will be on the science and on the products. We have some very exciting things cooking now at Genmab. The pipeline has never had the quality it has now, and we want to give you further insight in that and in some use of the novel technology platforms. We will, of course, also speak about some financial aspects, how we see the future, and also about the next phase and basically investing wisely and selectively in the potential winners. The bulk will be on the scientific and the development angle.
Great. Just a follow-up to that, because now we're talking a bit finances. Could you also, maybe Anthony Mancini or Judith Klimovsky, detail the increase in the G&A cost for the quarter? How much of this was the commercial cost related to ASR?
I hand that question over to Anthony Pagano, our CFO, and he can handle that for sure. Anthony?
Great. Carsten , looking about sort of the higher G&A costs, I think there are a couple of moving parts here, right? In terms of R&D versus G&A split, for Q1 this year, we're 87, 13, and for Q2, we're at 81 versus 19. If I put those two quarters together for the first half of the year, we're at 84, 16, right? Maybe I'll sort of talk you through these actual moving parts with that framework. For the H1 2020, we have higher costs compared to last year, and a lot of this is down to incremental costs following our U.S. IPO in July of 2019. Separately, apart from those sort of ongoing recurring costs, separately for Q2 2020, we do have some one-off costs that we incurred in conjunction with the AbbVie collaboration.
If we were to exclude these one-off costs, our R&D and G&A costs for Q2 would be more similar to what we saw in Q1. There are some moving parts here, Carsten, but there is certainly this one-off element that I just described, which is impacting the numbers.
Okay, makes sense. Thanks.
Thanks, Anthony. Thanks, Carsten, for the questions.
Our following question comes from the line of Emily Field from Barclays. Please go ahead.
Hi, can you hear me now?
Yeah.
Great. Sorry. I don't know what happened. Thanks for answering my other question. I just had another follow-up. I believe in one of the prior answers you mentioned, at epcoritamab, having a place kind of across all lines of therapy. I just wanted to dig into that, in terms of what maybe you see as the ideal place for the drug in terms of the treatment paradigm in DLBCL, whether relapsed/refractory 2nd line, if you could just give some more thoughts on that.
Thanks, Emily. I will pass the question over to Judith.
Yeah, no, thank you for the question. I think it's premature. I think that there are still unmet medical needs in every line of therapy, and this is what I'm most excited about because this is where the impact on patients will be more evident and remarkable. Still, I think that we are looking for opportunities to improve the whole continuum of treatment, given the differential aspects and potential transformative nature of CD3xCD20. I will stop there.
Thanks, Judith.
Thank you.
Thanks, Emily.
Our following question comes from the line of Laura Sutcliffe from UBS. Please go ahead.
Hello. Thank you. Just a quick one on DARZALEX, please. Could you give us any thoughts on how you're looking at the potential in the amyloidosis market, and in particular, any thoughts around duration would be welcome. Thanks.
Thanks, Laura, for the question. I think I will first hand it over to Judith and then probably Anthony Mancini. Judith?
Yeah. Thank you, Jan. For amyloidosis, I am personally, as a hematologist, super excited about these results because as you know, there are no drugs approved in amyloidosis. It's really rewarding as a hematologist to see something that provides such a benefit in terms of organ damage. As you know, many tried, but nothing succeeded. Again, I'm talking about the full package of DARZALEX. In terms of market. It's hard to predict because the prevalence, like in the U.S., for example, they say that it's 12,000 patients living with amyloidosis. As you know, when there are no good treatments, diseases are not in the radar screen of physicians and therefore not diagnosed, under-diagnosed, or diagnosed late. It's very hard to predict.
What is underneath the work, let's say, the patient population that have amyloidosis, that they don't get a Congo red test to be diagnosed because there's no awareness if there is not a good treatment. Part of understanding the commercial opportunity is working on really an awareness campaign, not only because this is not a disease that comes through hematologists. It comes through cardiologists, through nephrologists, through clinicians, because this is the prototype for symptoms of the disease. This is from a medical background. Now, Anthony , if you want to elaborate more on, yeah.
Thanks, Judith.
No, thanks, Judith. I don't know that I can add much more except to say that really this is great news for patients. As you mentioned, it's an area of huge medical need and yet another positive data set to add to the many positive DARZALEX data sets. I think once filed and approved, J&J is probably best positioned to provide more color on incremental impact and duration. It's a great question, Laura. Thank you.
Thanks.
Thank you, Laura. The next one.
Our following question comes from the line of Graig Suvannavejh from Goldman Sachs. Please go ahead.
Thank you for taking my question. Congrats. Hey, can you hear me? Hello?
Yes, we can hear you now. Yep.
Okay. Sorry about that. First of all, thanks for taking my question and congrats on all the progress and your achievements here to date. I had just one question on capital allocation. You've got a very nice cash balance right now. I'm just wondering, as you think about your business, where are you prioritizing investments? Is it in the internal pipeline? Is it around commercialization? Are you thinking strategically around BD opportunities? Any color around how you're thinking about that would be appreciated. Thank you.
Thanks, Graig, for the question. I will first hand it over to Anthony Pagano and then see whether Anthony wants to add anything on the commercialization, which is a very important part of the company now going forward. Anthony Pagano.
Yeah. Graig, good to hear your voice and chat with you today. Look, I think first of all, I was thinking about our balance sheet. You're right for pointing out we do have a strong balance sheet. I think this has sort of been very useful for us here over the most recent period, right? I think more recently, we sort of think about being able to look through any issues as it relates to COVID-19 from that position of strength. That the strong balance sheet also meant when we were negotiating and what ultimately resulted in the wonderful collaboration with AbbVie, that we were also able to negotiate from a position of strength for that collaboration. I think moving forward, the strong balance sheet is going to continue to be super important as we execute towards our 2025 vision.
Now with the Tiso data, there's potentially a clear path to market there. We'll have to wait and see and work our way through the FDA interactions, but we're super excited about that. Also looking at our pipeline and how that's maturing. Having that rock-solid balance sheet means that we can absolutely execute against moving those programs forward and our 2025 vision with sort of the absolute confidence and the power of the balance sheet behind us. Thinking a bit about our maybe OpEx levels moving forward, we're going to continue to be focused and disciplined as we invest in our business and the growth opportunities that are in front of us. I think we think about being focused and disciplined. There are really two sides to the coin, right?
On the one hand, when we think about discipline, we can think about de-risking investments and when we can, and making tough decisions along the way. That's really around discipline. On the other hand, thinking about focus, it starts with our focus strategy that we've alluded to, that we've been executing against since 2013, and that's our 2025 vision, right? We're really laser-sharp focused on delivering against that. Final point, Graig, as it relates to kind of external opportunities, I think we'll continue to be focused there, right? The theme I've talked about more recently is really where we can be natural owners, right? Where we can be good evaluators of what we're bringing in and then ultimately good owners of it once we have it in-house.
I think at least for the shorter term, more of the same in terms of the deals we've done more recently. Maybe Anthony , you want to add some stuff on the commercial side?
Yeah, no, look, I would reiterate what Anthony Pagano mentioned in terms of how the AbbVie collaboration is a critical step towards our 2025 vision. Part of investing behind that thoughtful step is really being thoughtful about our priorities from a commercialization standpoint. We've taken steps now to start to build our commercial organization in the U.S. and Japan, recently making key strategic appointments there, and we'll continue to do that. Looking externally, we'll continue to look for, as Anthony Pagano talked about, opportunities to complement what we have, opportunities to deepen what we have and accelerate our quest to achieve that vision and beyond. I think I'll leave it there, Jan, and pass it back to you. Thanks, Graig, for the question.
Thanks, Anthony. Anthony, I think, Graig, we'll leave it with this here.
Okay, thank you.
Our last question comes from the line of Sachin Jain from Bank of America. Please go ahead.
Hi there.
Hi.
Thanks for putting me onto the call. Just a couple of pipeline questions to wrap up. On epcoritamab for the CMP in November, will you be able to outline the full phase III program at that point? By then, do you expect to have visibility on how you propose the timeline versus competition on a faster market strategy to be able to give us further color there? Second question is on HexaBody-CD38. Do we still expect some initial data from that through 2021? The final question, obviously there's a lot of exciting data coming to year-end, but I wonder if you could just flag some earlier-stage assets which will be giving initial data next year that we can perhaps begin to focus on now. Thank you.
Thanks, Sachin. Let me start with question two. I will give the first one to Judith so that she can think about what will be known at the time of Capital Markets Day and can communicate it separately, given the competitive landscape on adcetrisumab. For HexaBody-CD38, we still plan to move it into the clinic this year, so it's fully on schedule, Sachin. I think at the very earliest, end of next year, we could see some data, but more likely in 2022. In the new year, probably some early data from some of the programs which are now in the clinic. We now have several new programs in the clinic. It could be the DuoHexaBody-CD37 program, but that could be in the second half of 2021, I would say.
For the DuoBody-CD3x5T4, probably second half of next year at the very earliest, or in 2022 more realistically. Maybe, Judith, you can give some further color to Sachin on the full phase III program for tisotumab vedotin as we are working on a plan with that field.
At Capital Market Day, we won't disclose all our plans because it won't be smart from our part. By November there will be the clinical development map. You will have two more tick points on that map to guide you on the whole journey. We will never, ever discuss at the Capital Market Day the whole clinical development plan because there's no way to do that.
Thanks.
Thanks, Sachin.
There are no further questions at this time. Please go ahead.
All right. Thank you all for calling in today to discuss Genmab financial results for the first half of 2020. If you were not able to get your question or you were unable to get to us with the question, please reach out to the investor relations team. We hope that you all stay safe, remain healthy, keep optimistic, and very much look forward to speaking with you again soon. This concludes the call.