Hello, and welcome to the Genmab conference call to discuss the company's financial results for the period ended March 31st, 2021. With me today to present these results is our CFO, Anthony Pagano. 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. Genmab has an innovation-based culture, collaborations and partnerships have always been part of our DNA. During today's presentation, we will reference some of the products being developed under these strategic collaborations, this slide acknowledges those relationships. Let's move to slide four. Through our 22-year history, we've had a laser-sharp focus on harnessing the power of human antibodies to develop differentiated cancer therapeutics.
This slide provides a review of what is behind that focus, our core purpose, which guides our work, our extremely successful strategy, and our ambitious vision for the company. Genmab's evolution into a fully integrated biotechnology powerhouse continued with the events of the first quarter of 2021. Now let's move to slide five and a look at some of these recent achievements. We continue on our ambitious path to bring our own medicines to patients and are excited about the recent U.S. FDA's acceptance of the tisotumab vedotin BLA for priority review based on the innovaTV 204 phase II study. If approved, tisotumab vedotin would be a first-in-class therapy, and we believe that it has the potential to become an important treatment option for patients with recurrent or metastatic cervical cancer. The preferred target date for potential U.S. FDA approval is October of this year.
Along with our partner, Seagen, we continue to assess our regulatory strategy for submission of tisotumab vedotin in metastatic cervical cancer with health authorities and plan to prepare the most robust regulatory package to support the potential regulatory approval in Japan and the rest of the world. A submission in Japan will take place later than we initially anticipated to ensure we meet the Japan Health Authority requirements; our pipeline for potential filing in Japan will reflect the inclusion of data from the innovaTV 301 phase III study. The first patient was dosed in this study during the first quarter of 2021. Additional pipeline progress included the first patient dosed in the first phase III study of epcoritamab and the first ever patient dosed with HexaBody-CD38.
The company also expanded our executive management team on March 1st, when, as we discussed during our full year 2020 results presentation, Dr. Tahi Ahmadi was appointed to the position of Chief Medical Officer for Genmab. In addition to progress in our own pipeline, the power of Genmab's innovation was reflected in important updates for therapies created by Genmab that are being developed by other companies. Let's move to slide six. As a reminder, there are currently three Genmab-created therapies on the market developed and commercialized by other companies, DARZALEX, Kesimpta, and TEPEZZA. During the first quarter of 2021, there were significant events for both DARZALEX and Kesimpta. In January, Janssen's DARZALEX FASPRO became the first and only FDA-approved treatment for AL amyloidosis.
Sales over the quarter were also strong. We reported $1,365 million in net sales by J&J, an increase of 46% over the first quarter of 2020, resulting in DKK 984 million in royalties to Genmab. Turning to Kesimpta, at the end of March, Novartis received approval in Europe for the treatment of relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features. This approval makes Kesimpta the first bispecific therapy that can be self-administered once a month at home, both in the U.S. and in Europe. We are enthusiastic about the future of all three of these medicines as they exemplify our commitment to applying our world-class antibody expertise to create differentiated antibody therapeutics with the potential to fundamentally improve patients' lives.
As Anthony will discuss in further detail, the collaborations for these three medicines provide us with the financial foundation of our current success with recurring revenue from royalties, which we can then use to invest further in our business to deliver our inspirational vision. I am pleased to now turn over the call to Anthony. Anthony, please go ahead.
Great. Thanks, Jan. Let's move to slide seven. To start, I'd like to take a moment and highlight our financial framework and the related key drivers. First off, let's think about our revenue profile. On the left, you can see our current and future recurring revenue streams. You're all very familiar with our three existing approved products as DARZALEX, TEPEZZA, and Kesimpta. Each of these have exceptional growth profiles and are expected to generate significant cash flows for us for the years to come. We have two potential revenue streams that could come online later this year. We submitted the BLA for tisotumab vedotin in Q1. At the end of last year, Janssen submitted a BLA and an MAA for amivantamab. If both are approved, that will bring our total number of approved products to five, which for me is really exciting.
Now on to our focused approach to investment shown on the right. We'll continue to invest in our business and capabilities to position us for sustained success. We'll accelerate and expand the potential winners in our pipeline. We'll also ensure we're ready to launch should tisotumab vedotin, and in the future, epcoritamab be approved. As well as investing, we'll of course remain focused on the bottom line. Let's take a closer look at an important component of our recurring revenue growth, DARZALEX sales on slide eight. We saw continued strong performance for DARZALEX in Q1. You can see that in the chart on the left. Overall, DARZALEX sales grew by 46%. That's net sales of nearly $1.4 billion, which translates to DKK 984 million in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the SubQ formulation.
DARZALEX remains a key driver of our revenue, as you can see on slide nine. Looking at the graph on the left, you can see our revenues grew by 77% in Q1. There were two main drivers. First, recurring revenue grew by 30%, and that's primarily due to higher DARZALEX royalties. Second, we recognized milestone payments from AbbVie for epco and from Janssen for daratumumab. Coming back to our recurring revenues, it's useful to unpack this a bit. We've already spoken about DARZALEX and the very strong performance there. For Kesimpta, we're encouraged by the nice quarter-over-quarter growth seen in Q1 and the recent approvals in Europe and Japan. On to TEPEZZA. Here, due to the supply chain disruption, we didn't record any royalties for the quarter.
However, we believe the strong fundamentals of the product remained intact, and we were pleased to hear the positive commentary from Horizon earlier today, and that they have started to supply the market again. Our revenue profile continues to get stronger, and we're taking those revenues and investing in a highly focused way, as you can see on the next slide. Total operating expenses grew by 28% in Q1, and here you can see where we invested. We accelerated our investment into our product portfolio, especially the advancement of both epco and DuoBody PD-L1, 4-1BB. We've also spent more on expanding our team, hiring key team members to support our growing product pipeline. We've continued to build our commercialization and broader organizational capabilities to support our expansion.
Finally, we are leveraging the AbbVie collaboration by utilizing their expertise and significant financial contributions to further expand and accelerate our partnership programs. Let's look at our financials as a whole on slide eleven. Here you can see our summary P&L. For Q1, revenue came in at approximately DKK 1.6 billion, up nearly DKK 700 million. The increase was primarily driven by higher DARZALEX royalties and the milestones related to epco and Dara, I mentioned earlier. Total expenses were slightly north of DKK 1 billion, with 81% being R&D and 19% G&A. Operating income was DKK 532 million compared to DKK 71 million last year. Our net financial items amount to a gain of DKK 892 million, which was primarily driven by unrealized foreign exchange rate gains related to our U.S. dollar-denominated cash and investments due to the move higher in the dollar during the quarter.
We have tax of DKK 328 million, which equates to an effective tax rate of 23%. That brings us to our net income of DKK 1.1 billion. By any measure, the first quarter of 2021 was extremely strong. Let's take a look at our guidance on slide 12. Following our strong Q1 numbers, I want to provide some additional color on where we are headed for the balance of the year. We are confirming our full year guidance. If we look at our revenues, we're unquestionably off to a strong start. With our market of products that are generating royalty revenues. We really like what we've seen here in Q1 from Dara and Kesimpta, and we're looking forward to TEPEZZA coming back online. For me, moving forward, it will be important to see this momentum continue as we progress into Q2 and Q3.
We have a fairly sizable chunk of revenue to come in order to hit our non-recurring revenue guidance, which includes both milestones and cost reimbursement. For operating expenses, we expect to step up our investments as the year progresses. This is in line with our overall strategy and the key priorities I highlighted at our Capital Markets Day in November and reiterated in February. For us, it starts with our focus on progressing epco and the rest of our pipeline and preparing for the potential launch of tisotumab vedotin later this year. Putting all this together, we're on track to deliver another year of substantial operating income in a range of DKK 1 billion-DKK 2 billion. For my final slide, let me provide a few closing remarks. In summary, we've had a very solid start to the year.
We've created growing recurring revenue streams based on products with exceptional growth profiles, that gives us a strong backbone of significant underlying profitability. We're investing those revenues in a highly focused way to realize our vision and capitalize on the significant growth opportunities in front of us. On that note, I'll hand you back to Jan to discuss our key priorities.
Thanks, Anthony. Let's move to slide 14. As we have discussed, our key priorities are essential to our success in 2021. With the submission of the tisotumab vedotin BLA and the subsequent receipt of priority review, we are on track toward reaching these goals, even with the adjustment of our timeline for the tisotumab vedotin regulatory submission in Japan. All other goals remain on track, and thanks to the excellent work and tireless dedication of our team members, we will continue to focus our resources on further progressing, expanding, and developing a world-class antibody product pipeline. We very much look forward to providing you with updates on a number of our clinical programs over the course of this year as we evolve into a leading, fully integrated biotech innovation powerhouse. Let's move to our final slide 15. That ends our presentation of Genmab's first quarter 2021 financial results.
Operator, please open the call for questions.
Thank you. If you wish to ask an audio question, please press zero one on your telephone keypad. If you wish to withdraw from your question, you may do so by pressing zero two to cancel. Once again, please press zero one on your telephone keypad if you wish to ask an audio question. Our first question comes from Wimal Kapadia from Bernstein. Please go ahead.
Thank you very much for taking my questions. Wimal Kapadia from Bernstein. Just a first one, a bit of clarity, please, just on the Halozyme Therapeutics royalty impact. I see a DKK 64 million impact in 1Q, can you just confirm what percentage of sales in the quarter came from the SubQ? How does Genmab think about that number by the end of the year, and what do you think will be steady state? My second question is just on amivantamab, please. I appreciate this is a J&J asset, I'm curious to hear Genmab's view on the potential for the drug. The initial target is exon 20, given J&J are running trials in a broader population and head-to-head versus TAGRISSO, the profile of the products may change significantly.
How are you thinking about the contribution for this asset, and what impact does that make for Genmab? Thank you.
Thanks, Wimal, for the questions. I will definitely park the first one for Anthony so he can think about that one for the Halozyme royalty rate. Let me take the amivantamab one. As we both know, the initial population in lung cancer is quite small. It's a subset of patients and a very small subset. There is already a trial ongoing in a much larger population with amivantamab, an over 1,000 patient trial as we know, which is representing about 20% of the lung cancer patients. We think that the contribution of amivantamab to our income stream, Wimal, for this year will be very limited. We assume an approval in the middle of this year for a subset of lung cancer patients.
If actually that larger population would read out positively, then the income profile is quite substantial, especially when you realize that we get royalties from the high single-digit to the low double-digit percentage range. That's pretty substantial in potential. I think I'm going to park it here. I think we will first need to see the data from the larger phase III trial before we can really project income streams more reliably. I think next year we will probably, in our guidance, take into account the amivantamab contribution if the product is approved, Wimal. For this year it will be small. We will update you hopefully in Q3 and Q4 of this year, assuming that we get a mid-2021 approval for amivantamab as the first DuoBody generated antibody product.
The nice thing is there's now 13 DuoBody molecules in the clinic, five by Genmab and seven by Janssen and one by Novo Nordisk. I think this will be the year that I think DuoBody will become very hot on the radar screen as a key technology for driving excellent next generation antibody products, not only for Genmab, but also for partners of Genmab. We see that list getting longer for sure already within 2021. Having said that, I'm going to hand over to Anthony to see what you can say about the Halozyme contribution now and potentially near the end of the year. Anthony, the floor is yours.
Great. Yeah. Thanks, Jan and Wimal. First of all, I certainly appreciate that you want to fine-tune your models, and I'll try to be helpful as I can, but I think you can also appreciate I really can't comment on the specific royalty that J&J is paying to Halozyme. That's really a relationship between the two of them. Maybe I'll try to walk you through some additional pieces of information, and we can hopefully still be helpful. Overall, the key message I want to leave you with here today is that the guidance that we gave on this back in February remains intact. Here what I said was that the full year impact would be around DKK 450 million . For Q1, the headwind was DKK 64 million . For 2021, we expect more than 50% of global DARZALEX sales will be SubQ.
What we've seen is a rapid uptake of the SubQ in the U.S. and in other parts of the world. To provide a little bit more context, in the U.S. market, where we have the best visibility to some data, currently SubQ accounts for around 60% of DARZALEX gross sales according to IMS. This compares, to give you a sense, to around 50% at the beginning of the year. As a reminder, we do have limited access to timely info in terms of splits of sales between IV and SubQ in markets outside the U.S. I think, to get to the other part of your question, if we step back for a moment, we continue to believe the overall growth profile for dara, including the SubQ version, is exceptional, and we expect the trend towards strong SubQ conversion will continue.
Hopefully that gives you some context, Wimal, in terms of where we're headed for the balance of the year and where we landed in Q1.
Great. Much appreciated. Thank you.
Thanks, Wimal.
Our next question comes from Michael Schmidt from Guggenheim. Please go ahead.
Hey, guys. Thanks for taking my questions. I had a few on epcoritamab. Perhaps first, I know you have an update coming up here at the ASCO conference. Could you just help us understand how significant this update will be, perhaps relative to what we've seen at ASH last year? Will there be a focus on the phase II expansion cohorts perhaps, or is it longer-term follow-ups still on the dose escalation portion of the study? Secondly, could you remind me what the target size is of the three planned expansion cohorts in this study, and what duration follow-up perhaps, is required for potentially filing for accelerated approval in those indications? Lastly, where are you with respect to meeting potential CMC manufacturing requirements for potential approval down the road? Thanks so much.
Thanks, Michael, for the questions. The abstract you've seen the title of for ASCO will be a follow-up, an update on the dose expansion cohorts in follicular lymphoma, diffuse large B-cell lymphoma, and in mantle cell. It will give you more information and clarity on duration of responses, the development of the depth of the responses, et cetera, but no data from the expansion cohorts. It's from the dose escalation part from the phase I/II. The other data in different tumors, potentially also in CLL, may be scheduled for the second half of the year, Michael. That's what I can say right now on epco data at ASCO. The abstracts, I think, will come out, I think, on the 19th of May, I see when I know. The expansion cohorts will be over 100 patients for each of the expansion cohorts.
The diffuse large B-cell lymphoma one is the most advanced, followed by follicular lymphoma and then mantle cell. Hopefully updates also during this year on how that progresses. We think that each of these could potentially be used for potential accelerated filing if the data would allow that, and we certainly will have interactions with the regulatory authorities on that. Finally, your CMC question that is in full swing, and potentially supporting us to assuming that the expansion cohorts will read out positively, Michael. We can potentially file in 2022 for an accelerated pathway for at least one of these expansion cohorts, perhaps more, depending on how recruitment will go in the coming time. CMC is completely on board and in line with a potential product filing and approval within 2022.
I think further news probably during this year, Michael, and we'll keep you very firmly updated. What I can tell you also is that the more data we see, the more we become encouraged by the potential of epcoritamab. We think it's a fantastic candidate therapeutic. We actually get more and more reassurance that it is potential real best in class in this category.
Thank you, Jan. Appreciate it.
All right. Thank you.
Our next question comes from Jonathan Chang from SVB. Please go ahead.
Hi, guys. Thanks for taking my questions. First question, when should we expect to see updated GEN1046 data this year?
We have not yet decided on the exact timing, but it will be in the second half of this year, and we expect you to see data coming from different expansion cohorts at the right dose, Jonathan. We're going to pick one of the conferences likely in the second half of this year.
Understood. Second question, I wanted to touch on a topic that we haven't heard much about. I'd love to get your latest thoughts on your partnership with Immatics and the ongoing efforts there. What's the latest status of those early-stage initiatives? More broadly, what are your thoughts on the promise and risks associated with TCR bispecifics? Thank you.
Thank you, Jonathan, for that question. We haven't had that one for a long time. I can tell you that the partnership is progressing really well. We have generated panels against a number of targets, and we have created bispecifics that we are now comparing to actually select out empirically the most potent molecule. You know that our strategy is with the DuoBody technology platform, is to actually generate lots of candidates and then empirically screen for the most potent ones. We are in that process, Jonathan, with some of the Immatics programs. It's a number of them running in parallel. We believe that these unique antibodies, which can be made by Immatics technology, which are targeting totally tumor-specific epitopes in the context of MHC molecules are very promising molecules to allow for really specific bispecific-mediated tumor cell targeting.
We are very excited about the potential of the technology. I think the partnership is going well. It's progressing. Hopefully, probably within this year, we come to final clinical candidates, and then we can then discuss also in more detail the route towards the clinic, et cetera. We think the potential is absolutely there, but we are still in the midst of generating really good therapeutic candidates from panels of bispecific antibodies. I think one of the strengths of Genmab's approach is that we actually have been very good in selecting truly differentiated product candidates because of the robustness of the DuoBody platform. That I think is the basis of us being so successful in actually progressing IND candidates towards the market up to now.
With the company, we think that hit rate is going to get better rather than worse going forward, because I think we understand better and better what makes a good candidate antibody a component for a differentiated next generation antibody drug. We will see a number of really, really promising candidates from other partnerships and from our own in-house pipeline, moving towards the clinic very rapidly. There will certainly be updates, Jonathan, this year. We will broaden the pipeline from eight proprietary clinical programs to a higher number this year. Some of them will be bispecifics and others may come from other technology platforms like our HexaBody platform. That's probably where I need to leave it at this time.
Thank you.
Thank you.
Our next question comes from Emily Field from Barclays. Please go ahead.
Hi. Thank you. I was just wondering if you could provide any color on the increase in the expected enrollment in the ongoing GEN1046 study, and whether you think that any of the data from that trial could be registrational. Thank you.
Thanks, Emily. We have, I think right now, nine expansion cohorts which we are recruiting patients for. You will see more expansion cohorts for GEN1046 in the coming time. I think each of these expansion cohorts can be expanded to a number of patients which could potentially support accelerated regulatory approval paths. I think it's a bit too early, Emily, to say more about it right now, I think there is definitely potential that we could find data in some of these expansion cohorts, which would allow us, upon discussion with the regulatory authorities, to go for a rapid and accelerated approval path. I think more data will be presented this year, in the second half of this year, then more next year. We continue to be very, very excited about that molecule.
You've already seen a combination between GEN-1046 and TAXOTERE, a chemotherapeutic, in one of the cohorts, and there will be other new expansion cohorts added in the coming time. We look forward to be able to present data to you all within this year at a medical conference.
Thank you.
Thank you, Emily.
Our next question comes from Sachin Jain, from Bank of America. Please go ahead.
Hi there. Sachin Jain. A couple of questions, please. Firstly, on epco. Jan, you mentioned the potential CLL data 2H. I wonder if you could just give us any early comments on signs of efficacy you're seeing in that setting. Are you aware of any other CD3/CD20s having seen efficacy in that setting? Secondly, on the 4-1BB, just to follow on to the last question. On the expansion of the recent study size, any comments you can make on what that implies re your comfort on liver tox, and whether you are seeing efficacy signals beyond lung? A follow-on, on the accelerated filing question. Some of the physician feedback we've had is that obviously the lung data in a very refractory population, data in 80-100 patients with roughly a 20% response rate could be a reasonable basis for an early file.
Just any comments you have there as to whether you've had any discussions in that regard. Thank you.
Thanks, Sachin, for the question. CLL, I think it's still early stages. We are recruiting patients in one of the studies with epcoritamab, and I can tell you we certainly see that we have an active drug there. I should probably keep it with that, Sachin. I think that is new data, that is unique data for a CD3, CD20 or CD20-targeted antibody. I think we need to see how the data develops. We're testing two different doses of epcoritamab in CLL. Hopefully in the second half of this year, we can show you the results from that initial set of patients being treated with epco. Moving to 1046, the PD-L1 4-1BB antibody. Liver tox, from the fact that I described to Emily that we are progressing different expansion cohorts, you can draw the conclusion that we actually can manage the toxicity
We think it's actually very manageable. What we see with GEN1046, this is a unique, very, very potent immune checkpoint targeted bispecific antibody. You ask for, is there evidence for other tumors than lung cancer of responses yet? The answer is absolutely yes. We have already described, I think it's SITC last year in November, triple-negative breast and ovarian cancer patients responding to this antibody. I think this is actually the very first 4-1BB targeted antibody which has shown to induce responses in patients which are refractory to immune checkpoint targeting antibodies before. I think it's a very promising concept. It's still early days, and we think that we need to see more data also on duration of the responses before we can draw further conclusions. We continue to be very, very excited.
That excitement is not only GEN1046, Sachin, also GEN1042, the CD40 4-1BB antibody is also doing very, very well. We hope to show you also in the second half of this year dose escalation data from that bispecific antibody. It's a different concept. It's targeting CD40 via an agonistic antibody arm and then 4-1BB on T-cells via the other arm of the bispecific. Also there we see clear responses at different dose levels, and we are going to progress that bispecific together with BioNTech as well, and initial clinical data to which we very much look forward to presenting in this year, probably also in the second half of this year. Then your third question was, have there already been contacts with regulatory authorities about some of the expansion cohorts with GEN1046?
The answer is no, not up to now, but we are following that progression really, really well and we'll give you updates once these are there, likely in the second half of this year, Sachin.
Thank you.
Our next question comes from Trung Huynh from Credit Suisse. Please go ahead.
Hi, guys. It's Trung from Credit Suisse. Just three questions from me, please. First one, just following up on Wimal's question on subcutaneous share. Can you just give us a bit more help or a ballpark of the share of subcutaneous DARZALEX in ex-U.S. for 1Q that you saw? On epco, and Roche's POLARIX study in first line DLBCL, which we'll see later this year. If it becomes the new standard of care, how does that change your thinking on epco's development program? Roche are targeting later lines of therapy. Are you still committed to your multiple line strategy here with combinations?
Finally, earlier this week, we saw Pfizer pause the enrollment of their BCMA CD3 due to neurotoxicity. I'm aware J&J is handling the development of teclistamab, can you perhaps give us your thoughts on peripheral neuropathy safety? Is there any potential this could be a class effect? Thank you very much.
Thanks, Trung, for the questions. I will definitely ask Anthony to speak more about the SubQ share ex-U.S., because he already did speak about the share in the U.S., which was over 60% now at trend. I'll park that question for Anthony. Let me move into epcoritamab development. Yes, the landscape is changing. We are continuously adapting our development plan, Trung. You will see a very rapid expansion of the number of studies for epcoritamab on ClinicalTrials.gov in the coming time. We will also speak about it very actively. You will see novel combinations, which have not been shown before for other CD3, CD20 bispecifics. Your question about multiple lines of therapy, for sure, we are now planning phase III and different lines of therapy for different B-cell cancers.
That enthusiasm level goes up and not down, also not despite the landscape changing term. I think this year will give you a lot more clarity on how we are going to position epcoritamab, and you will get more and more data, hopefully at ASCO initially, and then probably in the second half of the year a lot more data on different B-cell cancers, and that will hopefully help you to also build a better appreciation of the potential of epcoritamab. We are, together with AbbVie, getting more and more enthusiastic about the potential of this bispecific, which we think is truly unique and differentiated from the other CD20-targeted antibodies. The third question on the Pfizer BCMA CD3 bispecific. I cannot really comment on teclistamab because I really don't have an oversight of the data, the exact data.
What I can tell you is that there will be an oral presentation on teclistamab at ASCO, and actually also on talquetamab, the other bispecific antibody for multiple myeloma by Janssen, the GPRC5D CD3 bispecific. I think you would probably have heard it when they would have had stops by toxicity, like the toxicity seen with the Pfizer compounds. I think the technology base, Trung, is very different. What Janssen did in all of seven bispecifics in the clinic from the DuoBody technology, out of nine clinical candidates for different programs selected. For each of them, they made hundreds of candidates, which you only could do with a very good and robust technology like DuoBody. That is very different from what Pfizer did.
Pfizer did the initial, the very, very simplistic pasting together of arms of antibodies, which you can only do with a few antibodies and not with large panels. I think that the chance that teclistamab is a very, very different molecule from the Pfizer antibody is really there. You need to ask Janssen, I think, for more details on the toxicity profile of teclistamab. At the very latest, I think you will see an abstract on May the 19th on the oral presentation, and I think there's actually a few more abstracts also on posters. Poster presentations for teclistamab at ASCO. It's not possible for me to comment on that any further here. Anthony, do you want to speak a bit more on ex-U.S. shares of SubQ dara for Trung?
Sure. Thanks, Jan. Yeah, Trung, I'll try to be helpful here. Again, I do appreciate, similar to what I said to Wimal, you want to fine-tune your models. Again, I'll talk you through the way I think about this. It starts with that we certainly expect the trend towards strong SubQ conversion will continue. I walked you already through the specific metrics in the U.S. Again, here's where we actually have access to really what we think is good data via IMS on a real-time basis. For rest of the world, we really don't have access to the same quality of information. I guess what I can say, and this is, I think, reiterating what I said probably in the Q4 call.
In certain markets, following reimbursement, it almost becomes a little bit binary, not where it goes from 0- 100, but zero to a very high number rather quickly. Again, this is on a market-by-market basis, it comes down to the individual markets in terms of any particular market dynamics there for a particular market or country, and also the function of timing reimbursement approval as well. Trung, that's probably where I got to leave it, but ultimately, to conclude here, we see the overall trend towards SubQ adoption to continue.
Thanks, Anthony. I can probably share with you, Trung, that in some countries, there's over 90% usage already of SubQ dara. Like some of the Nordic countries and some other European countries, very large countries. In other countries, it's closer to 30%, but building up rapidly. I think Janssen can give you further color on that. We are not allowed to share anything further, but I think it's very, very rapidly progressing towards SubQ now in Europe. Thank you, Trung. Are you still there? I think, operator, we can probably go to the next question.
Yep. Our next question comes from Peter Welford from Jefferies. Please go ahead.
Hi. Thanks so much for taking my questions. Let me start with tisotumab. Just curious there if you can talk a little bit about whether you've had discussions yet in other markets outside of the U.S. and Japan with regards to what sort of clinical data is potentially required to consider a conditional accelerated type of pathway in those countries, and whether or not the decision in Japan to wait for 301 data impacts at all your thinking with regards to building your own commercial infrastructure, given the agreement with Seagen and how that sort of impacts that thinking. If I could just ask on DARZALEX, just with regards to the guidance. I know I don't think J&J made much comment about this, I'm curious if you have any insights into the first quarter trend ex-U.S.
Obviously, you're reiterating your aim, which seemingly if the first quarter sales were flat for the remaining quarters, you'd be above the midpoint of that. Curious as to what you're assuming with regards to the trend and what we should perhaps infer from the first quarter ex-U.S. number. Then just finally, sorry, a quick point of clarification just on amivantamab. I think Jan said it was royalties of high single to low double. Is that an equivalent term also for all of the J&J DuoBody, or does the royalty rate potentially vary by DuoBody? Thank you.
Thanks, Peter, for the questions. Let me take the first one and the third one, and then refer the dara guidance one to Anthony. Let's start with tisotumab vedotin. The situation in Japan is not impacting the strategy, Peter, for the other markets. For Europe, we also feel that we need the data from the 301 phase III study, which is recruiting right now of TV versus chemo in second and third-line cervical cancer patients. This year, we are expecting data from other cohorts, Peter, so we think that we can broaden the market beyond second and third-line. If this basically this new situation of the delay in Japan, which I spoke about in introduction and which is in the Q1 reports, impacting the buildup of the commercial teams, the answer is no. Definitely the introduction commercially in Japan will now be later than we originally envisaged.
Let's remember that also under the AbbVie agreement for epcoritamab, we need to prepare the commercial team in Japan also for actually moving epcoritamab to patients potentially even already in the next year or the year thereafter. We need to build up a commercial team anyhow. We probably do it a bit more slowly now because of the longer time needed for tisotumab vedotin. The infrastructure is really needed. We are very, very serious about the two priority markets. This will not impact any of the commercial arrangements with Seagen. We are super enthusiastic about working together with Seagen in the states, really getting ready, launch-ready already immediately after the summer, and hopefully get an approval done in the October timeframe for tisotumab vedotin in the states, and then start co-promoting the drug in the states together with Seagen.
That is all moving very rapidly in the right direction. Japan, I think a bit slowed down, Peter, but not very substantially, I can assure you at this time. We continue to be very motivated to actually build our commercial presence, starting with Japan and the U.S., and then later on, potentially looking at other markets in the future. Amivantamab, t he royalty rate is different for the different DuoBody molecules. What you may remember, Peter, is that we had two different sets of agreements with Janssen in, I think, 2012 and then in 2013 for a broader and broader set of DuoBody candidates for projects for Janssen.
Actually amivantamab is the one where we get the highest royalty, Peter, from all the DuoBody molecules, and the reason is that Genmab not only allowed access to the DuoBody technology platform by Janssen to create panels of bispecifics. We also created, physically created the EGFR arm and the c-Met arm, the panels which Janssen then used to build amivantamab from. Because of that reason that we also not only gave access to the technology, Peter, but also created the composing arms of this specific bispecific makes that we get a higher royalty for the other Janssen bispecifics. They are in the single-digit royalty range, Peter. I cannot be more specific. We are lucky because amivantamab is where Janssen needs to potentially pay us the highest royalty rate off because of that unique aspect that we created also the composing arms of the bispecific.
I think more data at ASCO, four different presentations, which is very exciting, I think. For Dara guidance, Anthony?
Yeah, thanks, Jan, and hi, Peter. Certainly after a strong Q1, I can absolutely see why you'd ask this question. For me, at this stage, and from my perspective, our guidance continues to be appropriate. Let me spend a few moments and explain why. To start, I think it's really useful to drill down into the geographic split in sales. For the U.S., sales of $691 million are up 49% compared to the Q1 in the previous year, the sequential quarter-over-quarter performance was more muted. Here it's not uncommon for us to experience lower to modest sequential growth in the U.S. in Q1 compared to Q4. We have to take this into account.
Now, if we look at the rest of the world, this was the real driver of the strong Q1 performance with sales of $ 674 million, which was up 20% compared to Q4 and up 42% year-over-year. We're really encouraged by the strong growth here. However, as we previously highlighted, we do have less visibility as to the individual markets and growth drivers. Also Q1, there were some tailwinds from FX. Another thing I want to highlight, which I think is useful to remind ourselves, and we've heard this from a number of other companies that have been here reporting during earnings season, that's that COVID continues to represent a challenge in terms of diagnosing new cancer patients and getting the needed treatment to existing cancer patients.
So far, this doesn't seem to have been a significant barrier for Dara, but it's something we need to take into consideration. Overall, if I sort of just take a step back from this, what we really want to see here is the strong momentum that we observed in Q1 really continue here as we move forward here into Q2 and Q3. With that, and to take all this together, Peter, I think, and I hope you can see why we feel our guidance continues to be appropriate.
Yeah. That's great. Thank you.
Thank you.
Thanks, Peter.
Our next question comes from Peter Verdult from Citi. Please go ahead.
Thanks. Peter Verdult, Citi. Jan, just to take you briefly away from the pipeline, then we can dive back in. The share price by our calculations, fully pricing in the downside from your spat with J&J. No DARZALEX royalties beyond 2030, despite you paying 50% of the Halozyme royalty for the foreseeable future. Just wanted to check in on arbitration. I know you're not going to say much, and you can't say much, but is there anything you can say on timelines or even willingness to seek resolution of this through alternative avenues? That's question number one. Onto the more interesting pipeline questions, just checking in on Mim8. Any sense or feel as to whether the emerging data is strong enough for a move into phase III? Just interested to hear your views on the asset, realize it's your technology in the hands of a partner.
The last question, this will just require a yes or no answer. Any chance we will see HexaBody-CD38 data that could lead to an opt-in this year, or is that very much a 2022 event? Thank you.
Thanks. Thanks, Peter, for the questions. Interesting questions for sure. Let me start with the arbitration. I can tell you that we are feeling very strongly that we are morally and ethically doing the right thing here by defending our position. Timing is uncertain, as I already said before, Peter. What I can tell you that the process is progressing very rapidly. Lots of documents are being exchanged, and I think both parties are working on the case. We would very much, like you, want that overhang, that perceived overhang to be disappearing as quickly as possible. It's in the hands of the judges and the process, so I cannot basically comment any further on timelines. There is a clear activity, I can tell you, at or and to really get that case finished in the shortest possible timeframe.
Yes, I think we have been hit by the uncertainty here. Sometimes in life, Peter, you have to keep your back straight when you feel that you're doing the right thing. This is one of those situations. Of course, we would be open to resolve this in any possible way. We have to defend our position here, and we feel that we are doing the right thing here and feel very strong. With Mim8, I don't know the data that well, but I know the preclinical data actually very well. This is a super well-differentiated molecule for hemophilia, created with the DuoBody technology platform, where Novo has seen over 15-fold better activity than seen with Hemlibra in in vitro studies.
I think the clinical data, Peter, will have to give you the guidance for how rapidly this can move to phase III. What I can tell you is that Novo is super enthusiastic about what they see clinically. I've not seen that data, and I hope that it will be presented pretty soon. That's definitely something we also look forward to quite eagerly. Then the third question escaped me. Maybe you can repeat it very briefly here, Peter.
Yeah, Jan, with your back straight, just a question on HexaBody-CD38. Just yes or no, is there any chance we will see data that could trigger an opt-in for that asset this year, or is that very much a 2022 event?
Oh, I think it's a full known, yes. Of course, Janssen could potentially wait on data from the comparison between HexaBody-CD38 and dara, SubQ dara, because they're entitled to wait on that data before deciding on the potential opt-in. I can tell you that we are now treating patients, Peter, and we think that this molecule is potentially 10-fold or more, more potent than dara. We could potentially, during the dose escalation, already see that this is a much more potent molecule and with the right safety profile, it is definitely possible that a company like Janssen, who wants to work on a follow-up or maybe a expansion from daratumumab, could opt in. There is definitely potential, but I think the likelihood is very low, Peter. I think they will want to see potentially more data.
We hope to show you some data in the second half of this HexaBody and force molecule. I think this will be a good year, as I already said before, for our DuoBody platform, the 13 molecules in the clinic and more to come. We have three HexaBody molecules in the clinic now. This, the third one, HexaBody-CD38. We are super enthusiastic about what we see with the different molecules. Also, the CD37 one is doing really well, I can assure you, clinically. I think this could be a good year for Genmab's technology platforms and put them firmly on the radar screen as technologies to allow for generation of truly differentiated, excellent antibody therapeutics. This will be a good year, Peter, and I think this could be one of the spearhead molecules for HexaBody.
It will still be early days, because I think the real comparison with DARZALEX will come, not this year, but potentially next year in 2022.
Thanks very much. Understand.
Thank you.
Thanks, Peter.
Our next question comes from Michael Novod from Nordea. Please go ahead.
Yeah, just a few follow-up questions. First of all, on the cash position. You're accumulating a lot of cash and you're going to be extremely cash generative in the years to come. Maybe just a brief update on sort of how you intend to deploy it in terms of targeting M&A, et cetera. That would be very interesting. Just a housekeeping question on the modeling in terms of net financials for the full year. Maybe Anthony has some comments to how we should expect that to pan out given the major boost we saw in Q1.
Thanks, Michael, for the questions. Perhaps I can start off with the first one, and then Anthony can step in there and then follow on with the modeling on net financials, Michael, for the second question. Genmab is going to really focus on the creation and development of differentiated antibody therapeutics. Yes, we are getting more and more cash rich. We will focus on accelerating the potential winners like we're doing now with GEN1046 and with epcoritamab. Potentially this year, we will actually identify another potential winner from our pipeline of now eight proprietary clinical programs, Michael, and we will further build the pipeline. In that process, we already discussed the Immatics collaboration.
We will enter new agreements with other companies, which can give us access to components, which we can then use together with that partner, Michael, to create differentiated next generation antibody therapeutic candidates. That will be an area where we will certainly spend money. You could see from the Q1 report that CureVac is a company we work with. We closed a deal a number of years ago, and we decided to sell actually 30% of the shares which we accumulated in our deal. That was to get access to our mRNA-based technology for potential future delivery of antibody therapeutics in the form of mRNA. We now know how enthusiastic the pharma field is about mRNA-based therapeutics.
You will see Genmab spend money in the coming time proactively in getting access to components, which we can use as building blocks to create truly differentiated next generation antibody therapeutics. Do expect to spend some money on that. We could potentially even acquire a technology platform if we think that that fits well with our portfolio of platforms already in the company. We will do this in a careful manner and then spend the majority of the cash on accelerating potential winners and bringing them to the market and then commercializing them, Michael, in the key markets. Initially focusing on the U.S. and Japan, and potentially later on also looking at other markets. That's probably where I want to leave it at this point, and then ask Anthony to chip in here.
Great. Yeah, thanks Jan. Michael, maybe see if I could add on to what Jan said. I think that the first thing would be that overall, I think historically, having this strong cash position has really served us well. Whether I think about a year ago now reflecting on it, where we were a year ago when the pandemic was emerging. The strong cash position, the recurring revenue profile meant we could really stay focused on executing against our strategy and our key priorities for last year. I think it's served us well historically. I also think as we sort of think about this growth cycle that we're in the middle of, having that really strong, robust balance sheet is going to continue to serve us well moving forward.
I think overall, this kind of level of cash on our balance sheet continues to be absolutely appropriate for running our business in the way that we have been. I think that gives you some color on that question, Michael, in terms of our cash position. In terms of the net financial items, I might ask you if you have a crystal ball as it relates to where the dollar or euro is going to go, that's what this is really about. If you look at the number really for Q1, it was really around the FX movement. The vast majority of the move was to FX, and it was really just a reversal of the FX loss that we saw in Q4. Now the majority of our cash and investment position is held in U.S. dollar-denominated securities.
It's really going to be a function of unrealized gains going through that line as the euro dollar moves. To give you some context, we ended the year, now I'm referring to Danish kroner dollar rates, we were DKK 6.05. We went up to DKK 6.34 at the end of the quarter, and now I believe we're at DKK 6.20 today. It's really going to be a function of that, Michael. I can't give you a precise guidance, but at least that gives you a sense of what's going through that line. The other thing is, since Jan alluded to it, and you can find this in our interim report, we did take the opportunity to take a little bit of money off the table with our investment in CureVac as we sold down around 30% of the position.
We're now holding at the end of the quarter around 1.5 million shares, and that's the other significant item flowing through that line. With that, Michael, hopefully that gives you a sense. If you have an inside track on where the euro dollar is going, just you know where to reach me and let me know.
Thanks. Thank you both.
Thanks, Michael. Operator, are there any further questions?
Thank you. Unfortunately, that's all time we have questions for. I'm going to hand back to the speakers.
All right. Thank you all for calling in today to discuss Genmab's financial results for the first quarter of 2021. If we are not able to get your question or when you're thinking about a question right now, please reach out to our investor relations team. We hope that you all stay safe and remain healthy and optimistic, and very much look forward to speaking with you all again soon.