So hello, and welcome to the Genmab conference call to discuss the company's financial results for the period ended March 31, 2021. With me today to present these results is our CFO, Anthony Pagano. Let's move to Slide 2. As already said, we will be making forward looking statements. So please keep that in mind as we go through this call.
Let's move to Slide 3. Genmab has an innovation based culture and 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 and this slide acknowledges those relationships. Let's move to Slide 4. 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. Thermo's evolution into a fully integrated biotechnology powerhouse continued with the events of the Q1 of 2021. So now let's move to Slide 5 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 INNOFA-two zero four Phase 2 study. If approved, tisotumor fedotin would be a 1st 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 PDUFA target date for potential U. S.
FDA approval is October of this year. Along with our partner, CEGEN, we continue to assess our regulatory strategy for submission of tislecomafedotin, a metastatic cervical cancer with health authorities and plan to prepare the most robust regulatory package to support the potential regulatory approval in Japan and 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. So our pipeline for potential filing in Japan will reflect of data from the Innovative 301 Phase 3 study. The first patient was dosed in this study during the Q1 2021.
Additional pipeline progress included the 1st patient dosed in the 1st Phase 3 study of abcaritamab and the first ever patient dosed with HexaBody CD38. The company also expanded our executive management team on March 1, when as we discussed during our full year 2020 results presentation, Doctor. Tai Amari 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 6.
As a reminder, there are currently 3 genlop created therapies on the market developed and commercialized by other companies DARZALEX, KESYMTA and TEPESA. During the Q1 of 2021, there were significant events for both DARZALEX and KESYMTA. In January, Janssen's DARZALEX FASPO became the 1st and only FDA approved treatment for AL amyloidosis. Sales over the quarter were also strong and we reported $1365,000,000 and net sales by J&J, an increase of 46% over the Q1 of 2020, resulting in DKK984 million and royalties to Genmab. Turning to KRYSTIMTA.
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 CECIMTA the 1st piece of 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.
And 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'm pleased to now turn over the call to Anthony. Anthony, please go ahead.
Great. Thanks Jan. Let's move to slide 7. To start, I'd like to take a moment and highlight our financial framework 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 3 existing approved products as DARZALEX, TEPEZZA and COSIMTA. Each of these have exceptional growth profiles and are expected to generate significant cash flows for us for the years to come. Then we have 2 potential revenue streams that could come online later this year. We submitted the BLA for tazomab vedotin in Q1.
At the end of last year, Janssen submitted a BLA and an MAA for amivantumab. If both are approved that will bring our total number of approved products to 5, 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 and will accelerate and expand the potential winners in our pipeline. We'll also ensure we are ready to launch should tazotamab vedotin and in the future epritimab 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 8. 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 $1,400,000,000 which translates to DKK 984,000,000 in royalty revenue. This exceptional growth was driven by continued strong market shares across all lines and by the strong uptake of the subcu formulation. So DARZALEX remains a key driver of our revenue as you can see on slide 9. Looking at the graph on the left, you can see our revenues grew by 77% in Q1. There were 2 main drivers.
First, recurring revenue grew by 30% and that's primarily due to higher Darzalex royalties. 2nd, we recognized milestone payments from AbbVie for EPCO and from Janssen for daratumumab. Now 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 COSIMTA, we're encouraged by the nice quarter over quarter growth seen in Q1 and the recent approvals in Europe and Japan.
Now on to Tepesa. Here, due to the We are pleased to hear the positive commentary from Horizon earlier today and that they have started to supply the market again. So 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 EFCO and dual body PD L1-four-1BB. We've also spent more on expanding our team, hiring key team members to support our growing product pipeline. And 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. Now, let's look at our financials as a whole on slide 11.
Here you can see our summary P and L. For Q1, revenue came in at approximately DKK 1,600,000,000 up nearly $700,000,000 The increase was primarily driven by higher DARZALEX royalties and the milestones related to EPCO and DERA I mentioned earlier. Total expenses were slightly north of $1,000,000,000 with 81% being R and D and 19% G and A. Operating income was $532,000,000 compared to $71,000,000 last year. Our net financial items amounted to a gain of $892,000,000 which is 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. Then we have tax of $328,000,000 which equates to an effective tax rate of 23%. And that brings us to our net income of $1,100,000,000 So by any measure, the Q1 of 2021 was extremely strong. Now let's take a look at our guidance on slide 12.
Following our strong Q1 numbers, I want to provide some additional color and where we are headed for the balance of the year. To start, we are confirming our full year guidance. If we look at our revenues, we're unquestionably off to a strong start. First, with our marketed products that are generating royalty revenues. We really like what we've seen here in Q1 from Dara and Cosimpta 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. In addition, 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 Epto and the rest of our pipeline and preparing for the potential launch of tazotamab 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 1,000,000,000 to DKK 2,000,000,000. Now 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. And 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. And 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. And with the submission of the tisotumor Fedotan BLA and the subsequent seek off priority review, we are on track towards reaching these goals even with the adjustment of our time line for the tisotumab vedotin regulatory submission in Japan. Our 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 our 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, Slide 15. That ends our presentation of Genmab's Q1 2021 financial results. Operator, please open the call for questions.
Thank Our first question comes from Wilmar Kapadia from Bernstein. Please go ahead.
Great. Thank you very much for taking my questions. Wilmar Kapadia from Bernstein. So just a first one, a bit of clarity, please, just on the Halozyme royalty impact. I see a DKK 64,000,000 impact in 1Q.
But can you just confirm what percentage of sales in the quarter came from the subcu? And then how do we think about how does Genlab 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 amivantumab, please. I appreciate this is a J and J I said, but I'm curious to hear Genmab's view on the potential for the drug.
The initial target is exon 20, but given J and J are running trials in a broader population and head to head versus Tagrisso, the profile of the products may change significantly. So how are you thinking about the contribution for this asset? And what impact did that make for Genmab? Thank you. Thanks, Wimal for the questions.
And I will definitely park the first one Anthony, so he can think about that one for the Halozyme royalty rates. Let me take the amifantumab 1. As we both know, the initial population in lung cancer is quite small. It's a subset of patients in a very small subset, but there is already a trial ongoing in a much larger population with amifantumab and over 1,000 patient trial as we know, which is representing about 20% of the lung cancer patients. So we think that the contribution of amivantumab to our income We model for this year will be very limited.
We assume an approval in the middle of this year for a subset of lung cancer patients. But if actually that larger population would read out positively, then the income profile is quite substantial, especially when to realize that we had kept royalties from the high single digit to the low double digit percentage range. So that's pretty substantial and potential. So I think I'm going to park it here. I think we will first need to see the data from the Phase III trial, the larger Phase III trial before we can really project income streams more reliably.
I think next year we will probably guide in our guidance take into account the amivantumab contribution if the drug is approved Wimal. But for this year, it will be small. And we will update you hopefully in Q3 and Q4 of this year, assuming that we get a mid-twenty 21 approval for amivantamab as the first dual body generated antibody product. And the nice thing is just now 13 dual body molecules in the clinic, 5 by Genmab and then 7 by Janssen and 1 by Novo Nordisk. And I think this will be the year that I think DuoBody will become very, very hot on the radar screen as a key technology for driving excellent next generation antibody products not only for Genmab, but also of partners of Zenmab.
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 can say about the Halozyme contribution now and potentially near the end of the year. Anthony, the floor is yours.
Great. Thanks Jan. And Vimal, first of all, I certainly appreciate that you want to fine tune your models and I'll try to be helpful as Ken, but I
think you can also appreciate,
I really can't comment on the specific royalty that J and J is paying to Hellasign. That's really a relationship between the 2 of them. But maybe I'll try to walk you through some additional pieces of information and we can hopefully this will be helpful. So 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. And here what I said was that the full year impact would be around DKK450 1,000,000.
For Q1, the headwind was DKK 64 1,000,000. For 2021, we expect More than 50% of global DARZALEX sales will be subcu. So far what we've seen is a rapid uptake of the subcu in the U. S. And 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 subcu accounts for around 60% of DARZALEX gross sales according to IMS. And this compares to give you a sense to around 50% At the beginning of the year. And as a reminder, we do have limited access to timely info in terms of splits of sales between IV and subcu It's 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 subcu version is exceptional and we expect the trend towards strong subcu conversion will continue. So Hopefully that gives you some context 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 epcaritumab. 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 is will there be a focus on the Phase II expansion cohorts perhaps?
Or is it longer term follow-up Still on the dose escalation portion of the study. Secondly, could you remind us what the target size Is of the 3 planned expansion cohorts in the study? And what duration follow-up perhaps It's required for potentially filing for accelerated approval in those indications. And 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 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. And it will give you more information and clarity on duration of responses, the development of the depth of the responses, etcetera, but no data from the expansion towards it's from the dose escalation part from the Phase III. The other data in different tumors potentially also in CLL maybe the schedule for the second half of the year, Michael. But that's what I can say right now on APCO data at ASCO and the abstracts I think will come out I think on the 19th May as you and I know.
The expansion cohorts will be over 100 patients for each of the pension cohorts, the diffuse large B cell lymphoma 1 is the most advanced, followed by follicular lymphoma and then mantle cell. So hopefully updates also during this year on how that progresses. And 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. And finally, your CMC question that is on in full swing and potentially supporting us to assuming that the expansion cohorts will read out positively, Michael, but 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. And CMC is completely on board and in line with a potential product filing and approval within 2022.
But 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 eperitimab. We think it's a fantastic candidate therapeutic. We actually get more and more reassurance that it is a 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.
Hi guys. Thanks for taking my questions. First question, when should we expect to see updated 1046 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 from different coming from different expansion cohorts at the right dose, Jonathan, but we are going to pick one of the conferences likely in the second half of this year.
Understood. And 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 Emmatix and the ongoing efforts there, what's the latest status of those early stage initiatives? And more broadly, What are your thoughts on the promise and risks associated with PCR 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 by with the dual body technology platform is to actually generate lots of candidates and then empirically screen for the most potent ones.
So we are in that process, Jonathan with some of the Imetix programs, so it's a number of them running in parallel. And we believe that these unique antibodies which can be made by AemetX technology, which are targeting totally tumor specific epitopes in the context of MHC molecules are very, very promising molecules to allow for really specific bispecific mediated tumor cell targeting. So we are very excited about the potential of the technology. I think the partnership is going well. It's progressing.
And 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, etcetera. So 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. And 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 dual body platform. And that I think is the basis of us being so successful and actually progressing the IND candidates towards the market up to now. But the company, we think that that hit rate is going to get better rather than those 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.
And 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 and there will certainly be updates Jonathan this year. So we will broaden the pipeline from 8 proprietary clinical programs to a higher number this year. And some of them will be bispecifics and others may be coming 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 Thill 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 9 expansion cohorts, which we are recruiting patients for. You will see more expansion cohorts for 1046 in the coming time. And I think each of these expansion cohorts can be expanded to a number of patients which could potentially for an accelerated regulatory approval part. I think it's a bit too early.
I only need to say more about it right now, but But 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 rapid and accelerated approval path. And I think more data will be presented this year in the second half of this year and then more next year. So we are we continue to be very, very excited about that molecule. You've already seen a combination between 1046 and take a toxotere, a chemotherapeutic in one of the cohorts and there will be other new expansion cohorts added in the coming time. So we look forward to be able to present data to you all within this year at a medical conference.
Thank you.
Thank you, Amelie.
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.
So wondering if you could just give us any early comments on signs of efficacy you're seeing in that setting? And are you aware of any other CD3, CD20s having seen efficacy in that setting? Secondly, on the 4 1BB, just a follow on to the last question. On the expansion of the recent study size, Any comments you can make on what that implies where your comfort on liver tox and whether you are seeing efficacy signals beyond lung? And then a follow on on your lung sorry, a follow on on the accelerated filing question.
Some of the physician feedback we've had is obviously the lung data in a very 3 population, data in 80 to 100 patients with roughly a 20% response rate could be a reasonable basis for an early file. So Just any comments you have there as to whether you've had any discussions in that regard? Thank you.
Thanks, Sachin, for the questions. So CLL, I think it's still early stage. We are recruiting patients in one of the studies with abgaritumab. And I can tell you, we certainly see that we have an active drug there. I should probably limit keep it with that session.
And I think that is new data. That is a unique data for a CCD20 or CCD20 targeted antibody. So I think we need to see how the data develops. We're testing 2 different doses of eplaritumab 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 APCO.
Then moving to 1046, the PD L1-four 100B antibody, Livotox 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 1046, this is a unique very, very potent immune checkpoint targeted by specific antibody and you ask for is there evidence for other tumors than lung cancer of responses? The answer is absolutely yes. And we have already described, I think at SITC last year in November, triple negative breast and ovarian cancer So patients responding to this antibody.
I think this is actually the very first four-1BB targeted antibody that has shown to induce responses in patients which are refractory to Immune checkpoint targeting antibody before. So I think it's a very, I think promising concept. It's still early days And we think that we can we need to see more data also on duration of the responses before we can to offer the conclusions, but we continue to be very, very excited. And that excitement is not only 1046 session also then 42, the CD4400B antibody is also doing very, very well. And 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 we have an agonistic antibody arm and then 400B on T cells, 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? And then your third question was, well, have there already been contacts with regulatory authorities about some of the expansion cohorts with 1046? 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, Sascha.
Thank you.
Our next question comes from Trung Young from Credit Suisse. Please go ahead.
Hi, guys. It's Truong from Credit Suisse. Just three questions from me, please. First one, just Following up on Dimal's question on subcutaneous share. Just can you just give us a bit more help or a ballpark Of the share of subcutaneous DARZALEX ex U.
S. For 1Q that you saw? Then on EPCO And Roche's Polarex 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 EFCO's development program? And what you're targeting later lines of therapy.
Are you still committed to your multiple line strategy here with combinations? And then finally, earlier this week, we saw Pfizer pause the enrollment of their BCMA CD3 due to pneumococcal. I'm aware J and J is handling the development of ciclistumab, but can you perhaps give us your thoughts on peripheral neuropathy safety? And is there any potential this could be a class effect?
Thanks, Trung, for the questions. And I will definitely ask Anthony to speak more about the subcu share ex U. S, because he already did speak about the share in the U. S, which was over 60% now at Pfung. So I'll park that question for Anthony.
Let me move into ecuritimab development. Yes, the landscape is changing and we are adapting continuously adapting our development plan, TRIM. You will see a very rapid expansion of the number of studies for aparitamab in on ct.gov in the coming time and then we will also speak about it very actively. You will see novel combinations This has not been shown before for other CD3, CD20 bispecifics. And your question about multiple lines of therapy for sure, We are now planning Phase 3s in different lines of therapy for different B cell cancers.
So that enthusiasm level goes up and not down, also not despite the landscape changing term. So I think this year will give you a lot more clarity on how we are going to position eparitamab 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 eptaritamab. We are together with that we're 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. And then the 3rd 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. But what I can tell you is that there will be an oral presentation on teclistamab at ASCO and actually also on talcretamab, the other bispecific antibody for multiple myeloma by Janssen, the TPRC5D CD3 bispecific.
And I think you would probably have heard it when they would have had stops by toxicity like the toxicity seen with the Pfizer compounds. But I think the technology base So it's very, very different. I mean what Janssen did in our 7 bispecifics in the clinic from the dual body technology, out of 9 clinical candidates for different programs selected. And for each of them, they made hundreds of candidates, which you only can do with a very good and robust technology like DuoBody. And that is very different from what Pfizer did.
I mean 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 panel. So I think that the chance that the ciclizumab is a very, very different molecule from the Pfizer antibodies really there. But you need to ask Janssen I think for more details on the toxicity profile of the clicklistermab. And at the very latest, I think you will see an abstract on May 19 on the oral presentation. And I think there's actually a few more abstracts also on posters.
So poster presentation, so please come up at ASCO. I think 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 Secudara for a trend?
Sure. Thanks, Jan. And Yes, Trung, I'll try to be helpful here. Again, I do appreciate similar to what I said to the model that you want to fine tune your models. But again, I'll talk you through the way I kind of think about this.
It starts with We certainly expect the trend towards strong subcu conversion will continue. We gave a walk through the specific metrics in the U. S. And 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, I mean, 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 to 100, but 0 to a very high number rather quickly. Again, this is on a market by market basis. So it comes down to the individual markets in terms of any particular market dynamics there, a particular market or country and also the function of time to reimbursement approval as well. So from that's probably where I got a little bit ultimately, to conclude here, we see the overall trend towards subcu adoption to continue.
Thanks, Anthony. And I can probably share with you Trung that in some countries there's over 90% usage already of subcu Dara, like some of the Nordic countries and some other European countries, very large countries and other which is closer to 30%, but building up rapidly. And 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 subcu now in Europe. Thank you, Trung.
Are you still there? I think operator, we can probably go to the next question.
Our next question comes from Peter Welford from Jefferies. Please go ahead.
Hi, thanks very much for taking
my questions. Let me start with cetozumab. 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 regard 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 Cgen and how that sort of impacts that thinking.
If I could then just ask on DARZALEX. Just with regards to the guidance, I think J and J made much comment about this, I'm curious if you have any insights into the Q1 trend ex U. S. Obviously, you're reiterating your aim, which Steven Lee, if the Q1 sales were flat for the remaining quarters, you'd be above the midpoint of that. So curious as to what you're assuming with regards to the trend and what we should perhaps infer from the Q1 ex U.
S. Number? And 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 curve also for the all of the J and J duo bodies?
Or does it does the royalty rate potentially vary by DUOBODI? Thank you.
Thanks, Peter, for the questions. Let me take the first one and the 3rd one and then refer the Dara guidance one to Anthony. Let's start with the sotamafedotin. 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 3 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. Is this basically this new situation of the delay in Japan, which I spoke about in my 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 we originally envisaged. But remember that also under the AbbVie agreement for abcaritumab, we need to prepare The team commercial team in Japan also for actually moving aducretumab to patients potentially even already in the next year or the year thereafter.
So 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 tisletoamafedoten, but the infrastructure is really needed. We are very, very serious about the 2 priority markets. This will not impact any of the commercial arrangements with Cision. We are Super enthusiastic about working together with Cheetion in the States, really getting ready, launch ready already immediately after the summer and hopefully get an approval done in the October time frame for tisotumafedotin in the States and then start co promoting the drug in the States together with CGen.
So that is all moving very rapidly in the right direction. So Japan, I think a bit slowdown, 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.
Then amifantamab, the royalty rate is different for the different Neuobody Molecules. What you may remember, Peter, is that we had 2 different sets of agreements with Janssen in, I think, 2012 and then in 2013 for a broader and broader set of dual body candidates for projects for Janssen. And the actually amifantumab is the one where we get the highest royalty, Peter, from all the dual body modules. And the reason is that Genlop not only allowed access to the dual body technology platform, by Janssen to create panels of By specifics, we also created physically created the EGFR arm and the CNET arm, the panels which Janssen then used to build amivantumab from. So because of that reason that we also not only gave access to the technology, Peter, but also created the composing arm.
So this specific bispecific makes that we get a higher royalty. And for the other Janssen bispecifics, They are in the single digit royalty range, Peter. I cannot be more specific, but we are lucky because avivantamab 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. And I think more data at ASCO, 4 different presentations, which is very, very exciting I think. Then for Dara guidance, Anthony?
Yes. Thanks, Jan, and hi, Peter. I mean, certainly after a strong Q1, I can absolutely see why you'd asked this question. For me at this stage and from my perspective, our guidance continues to be appropriate. Now 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 $691,000,000 were up 49% compared to the Q1 in the previous year, but the sequential quarter over quarter performance was more muted. So here it's not uncommon for us to experience lower to Sequential growth in the U. S.
In Q1 compared to Q4. So, 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 $674,000,000 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 and 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. Now so far, this doesn't seem to have been a significant barrier for Dara, but it's something we need to take into consideration. So overall, if I sort of just sort of 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. So with that and stick all this together, Peter, I think and I hope you can see why we feel our guidance continues to be appropriate.
Yes, that's great. Thank you.
Thank you. The next question comes from Peter Verdult from Citi. Please go ahead.
Yes, thanks. Peter Verdult, Citi. Jan, just to take you briefly Away from the pipeline and then we can dive back in. The share price by our calculations fully pricing in The downside from your spat with J and J, no DARZALEX royalties beyond 2,030, 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 Time lines or even willingness to seek resolution of this through alternative avenues? That's question number 1. And then on to the more interesting My questions, just checking in on MIM-eight. Any sense or feel as to whether the emerging data is strong enough For a move into Phase 3, just interested to hear your views on the asset, realize it's your technology in the hands of a partner. And then 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, was that very much a 2022 event? Thank you.
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.
But what I can tell you that the process is progressing very rapidly. I mean lots of documents are being exchanged and I think both parties are working on the case. And we would very much like you want that overhang, that perceived overhang to be disappearing as quickly as possible, but it's in the hence of the judges and the process. So I cannot basically comment any further on time lines, but there is a clear Activity, I can tell you at all and to really get that case finished in the shortest possible time frame. And yes, I think we have been hit by the uncertainty here.
But sometimes in life, Peter, you have to keep your back straight and you feel that you're doing the right thing. And that's this is one of those situations. And of course, we would be open to resolved this in any possible way, but we have to defend our opposition here and we feel that we are doing the right thing here and feel very strong. Than with MIMH. Yes, I'm not so I don't know the data that well, but I know the preclinical data actually very well and 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 and seeing at HEMLIBRA and in vitro studies.
So I think the clinical data, Peter, will have to give you the guidance for how rapidly this can move to Phase 3. But what I can tell you is that Novo is super enthusiastic about what they see clinically. I have not seen that data and I hope that it will be presented pretty soon, but that's definitely something we also look forward to quite eagerly? And then the 3rd question escaped to me, maybe you can repeat that very briefly, yes, Peter.
Yes. With your back straight, just a question on The 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?
All right. I think it's a full known yes. And of course, Janssen could potentially wait on data from the comparison between HexaBody CD38 and Dara, subcu Dara because they are entitled to wait on that data before deciding on the potential opt in. But 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. And 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.
So there is definitely potential, but I think the likelihood is very low, Peter, I think they will want to see potentially more data, but we hope to show you some data in the second half of this hexa body and force molecule. I think this will be a good year as I already said before for our dual body platform with 13 molecules in the clinic and more to come. We have 3 HexaBody molecules in the clinic now. This the third one, HexaBody CD38. And we are super enthusiastic about what we see with the different molecules.
Also the CD37 one is doing really, really well, I can assure you clinically. So 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. So this will be a good year, Peter. And I think this could be one of the spearhead molecules for exabody, but it will still be early days because I think the real comparison with Dara will come not this year, but potentially next year in 2022.
Thanks very much. I understand.
Thank you. Thanks, Peter.
Our next question comes from Michael Neufeld From Nordea, please go ahead.
Yes. Just a few follow-up questions. So first of all, on the cash position. So you're accumulating a lot of cash and you're going to be extremely cash in the years to come. So maybe just a brief update on sort of how you And tend to deploy it in terms of targeting M and A, etcetera.
That will be very interesting. And then 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. And 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. So Genmab is going to really focus on the creation and development of differentiated antibody therapeutics. And yes, we are getting more and more cash share risk rich. And we will focus on accelerating the potential winners like we're doing now with 1046 and with daparitumab and potentially this year we will actually identify another potential winner from our pipeline of now 8 proprietary clinical programs, Michael, and we will further build the pipeline.
And in that process, we already discussed the AMETYX color ratio. We will and on 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. And 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 that we accumulated in our deal and that was to get access to our mRNA based technology for potential future delivery of antibody therapeutics in the form of mRNA. And we now know how enthusiastic the pharma field is about mRNA based therapeutics.
So 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. So do expect to spend some money on that. And we could potentially even acquire a technology platform if we think that fits well with our portfolio of platforms already in the company. But 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 commercialize Michael, in the key markets, initially focusing on the U. S.
And Japan, potentially later on also looking at other markets. And that's probably where I want to leave it at this point and then ask Anthony to chip in here.
Great. Yes. Thanks Jan. And Michael maybe see if I could add on to what Jan said. I think the first thing would be That overall, I think historically this having the strong cash position has really served us well.
I mean, whether I think about when 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. So I think it's served us well historically. I also think as we sort of think about this growth cycle that we're kind of in the middle of Having that a really strong robust balance sheet is going to continue to serve us well moving forward. So 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.
So I think that gives you
some color on that A question, Michael, in terms of our cash position. In terms of the net financial items, I
mean, I might ask you if
you have a crystal ball as it relates to where the dollar, euro is going to go. And that's what this is really about. I mean, if you look at the number really for Q1, it was really around 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. So now the majority of our cash and investment position is held in U. S.
Dollar denominated securities. So it's really going to be a function of unrealized gains coming through that line as the euro dollar moves. To give you some context, we ended the year and I'm referring to Danish Kroner dollar rates, we were 605. We went up to 634 at the end of the quarter and now I believe we're at 6.20 today. So it's really going to be a function of that, Michael, so I can't give you a precise guidance, but at least it gives you a sense of what's going through that line.
And 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. And so we're now holding at the end of the quarter around 1,500,000 shares and that's the other significant item flowing through that line. So with that Michael hopefully that gives you a sense You have an inside track on where the euro dollar is going. Just you know what 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 we have questions for or time we have questions for. So I'm going to hand back to the speaker.
All right. Thank you all for calling in today to discuss GenMark's financial results for the Q1 of 2021. We will not 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.