Ladies and gentlemen, thank you for standing by and welcome to Genmab First Quarter Report 2020 Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone and wait for your name to be announced. During this telephone conference, you may be presented with forward-looking statements that include words such as believe, anticipate, plans, or expect. Actual results may differ materially. For example, as a result of delays or unsuccessful development projects. Genmab is not under an obligation to update statements regarding the future, nor to confirm such statements in relation to actual results unless this is required by law.
Please also note that Genmab may hold your personal data as indicated by you as part of our investor relations outreach activities in order to update you on Genmab going forward. Please refer to our website for more information on Genmab and our privacy policy. I must advise you that this conference is being recorded today. Now I would like to hand the conference over one of your speakers today, Jan van de Winkel. Please go ahead. We have some technical difficulties, please stand by. Please stand by while we dial out to our speaker today. Thank you. Thank you for waiting. Please go ahead. Thank you.
All right. Thank you. Hello, and welcome to the Genmab conference call to discuss the company's financial results for the quarter ended March 31st, 2020. Our CFO, Anthony Pagano, is joining me on today's call. You will also have a brief introduction to our new Chief Operating Officer, Anthony Mancini. Before I discuss the progress that Genmab has already made this year, I would like to address the unique circumstances under which we are presenting our first quarter results. The COVID-19 pandemic continues to pose unprecedented challenges in our lives and to companies across the globe. At Genmab, we are closely monitoring the evolving landscape created by this global health crisis and its potential impact on our employees, business, and key priorities. 2019 was Genmab's strongest year to date, both with regards to our pipeline and to our financials.
This solid foundation continues to position us very well for the future and for future growth, despite the uncertainty due to COVID-19. Let's move to slide two. As already said, we will be making forward-looking statements. Please keep that in mind as we go through this call. Let's now move to slide three. Now let's turn to some of the highlights from the first quarter of 2020. First, I would like to remind you of the recent changes to our executive management team. Anthony Pagano took on his new role as CFO at the end of February, and you will be hearing from him later in today's presentation. At this point, I would like to introduce you to Genmab's Chief Operating Officer, Anthony Mancini, who joined us in March.
In this newly created role, Anthony is responsible for ensuring that Genmab will be able to bring its innovative and differentiated medicines to patients around the world with his leadership of our commercial, corporate development, business development, and IT functions. I will now turn the presentation to Anthony Mancini to introduce himself. Anthony, please go ahead.
Thanks, Jan. Good afternoon and good evening, everyone. I'm excited to have joined Genmab, my first month here has been extremely positive. I'm very pleased to take on the commercial, IT, as well as the business and corporate development responsibility as we work together to achieve our vision of bringing our own differentiated medicines to the market. I've been impressed by the highly talented people, the innovative spirit, and the relentless drive at Genmab through the COVID-19 challenges and overall. Let me just share a little bit about my background. The vast majority of my career was spent at Bristol Myers Squibb, where I had the opportunity to launch and lead large teams of over 1,100 people across various functions in therapeutic areas, including oncology, hematology, immunology, transplant, and cardiovascular disease.
I've also had the privilege of leading several very successful partnership-based brands in the U.S. and around the world. I believe Genmab is in a unique position. It has a track record of creating highly innovative medicines, a rich and differentiated clinical pipeline, a solid financial position, and a fantastic team.
I'm really looking forward to continuing to work with the entire Genmab organization and our partners to bring innovative new cancer medicines to patients, and I'm also looking forward to meeting everyone on this call in person. With that, let me pass the call back to Jan.
Thank you, Anthony. We are very pleased that you have joined our leadership team. Let's now turn to our proprietary pipeline. We've maintained the momentum from 2019 with advances, including the dosing of the very first patient with a DuoHexaBody product, as DuoHexaBody-CD37 has now moved into the clinic. We look forward to an additional product in the clinic with the submission of the IND and the first CTAs for DuoBody-CD3x5T4. One of our products in collaboration with BioNTech, DuoBody-PD-L1x4-1BB, also progressed in its development with an expansion cohort initiated in a phase I/II trial in solid tumors. Finally, I'm pleased to announce that following initial data at last year's ASH, complete dose escalation and efficacy results from the phase I/II study of epcoritamab was accepted for presentation at this year's ASCO meeting.
As a reminder, we expect to have nine products in the clinic by the end of this year, so we are very well on our way. Recent progress was not limited to our proprietary products. In addition to the approval of Horizon's TEPEZZA, which I discussed during our full year results presentation, both U.S. and European authorities accepted Novartis' submissions for approval of subcutaneous ofatumumab in relapsing MS. At present, we still anticipate a potential U.S. approval in this indication in the first half of this year. Of note, one of the DuoBody products consisting of 100% Genmab-created antibody building blocks and now in clinical development with Janssen called amivantamab or JNJ-372, received a breakthrough therapy designation from the FDA, and this is the very first of such designation for a DuoBody product candidate.
For Darzalex, we reported $937 million in net sales by J&J during the first quarter, this was an increase of 49% over Q1 last year, resulting in DKK 775 million in royalties to Genmab. Given the challenging COVID-19 situation, we are very pleased with Darzalex's performance in Q1. In addition to its strong sales performance, Darzalex received an additional approval in Europe in the first quarter based on the CASSIOPEIA study, Janssen submitted applications for approval to regulatory authorities in the U.S. and Japan based on the CONDOR study. I'm extremely pleased to be able to conclude with the exciting U.S. approval of the subcutaneous formulation of daratumumab, now called Darzalex Faspro, this is a landmark approval for patients.
As we saw in the pivotal Phase III COLUMBA study, the fixed-dose subcutaneous formulation significantly reduced treatment time from hours to just three to five minutes, while still demonstrating similar efficacy and safety with significantly fewer administration-related reactions compared to IV daratumumab. DARZALEX FASPRO is the first and only subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma, we are very much looking forward to its launch, especially during these chaotic times, as it could provide patients with a choice for a faster treatment option. Of course, we are also looking forward to a potential approval in Europe, following the positive opinion from the CHMP for subcutaneous daratumumab, which occurred just one day before the U.S. approval. I will now turn the call over to Anthony Pagano to present our financial results for the first quarter of 2020. Anthony?
Thanks, Jan. Let's move to slide four. Before I get into the results and the guidance, I'm going to spend a moment reiterating our overarching financial framework because I think it provides a useful context against which to consider the impacts of COVID-19. First off, let's think about our revenue profile. On the left, you can see the component parts of our current and future recurring revenue streams. We are looking forward to the continued growth and expansion of DARZALEX. You can also see ofatumumab and TEPEZZA, and there's a lot to be excited about here. As we've heard from our potential partners, these are both potential blockbuster products, and we're really excited about the potential of adding two additional recurring revenue streams in the years to come. Next, on to R&D investment shown on the right.
We'll continue to be focused and disciplined in our approach, and we're going to expand and accelerate our potential winners. As well as investing, we remain focused on the bottom line. In 2019, we delivered our seventh consecutive year of profitability, and we continue to have a strong balance sheet with a significant cash position and no debt. When we put this all together, we have a robust financial framework and a strong foundation to continue to execute against our 2025 vision. Of course, we're not immune to COVID-19, and I'll return to that shortly.
Stepping back, what stands out for me from this overall framework is that at a time when growth may be hard to come by, Genmab is a resilient business with a very high-quality product pipeline and great growth prospects. With this context set, let's now take a closer look at an important component of our recurring revenue growth, DARZALEX sales on slide five. As you know, continued strong market growth led DARZALEX to near triple blockbuster status in 2019. For 2020, we anticipate that sales will continue to ramp up significantly. DARZALEX had continued strong market growth and share gains in the first quarter of 2020, with worldwide net sales of $937 million, a 49% increase over sales in the first quarter of 2019. This translates to DKK 775 million in royalty income for Genmab. DARZALEX is on a clear path to market leadership in multiple myeloma.
It's really continuing to deliver for us, and you can see that in the Q1 revenues on slide six. A revenue breakdown by category is shown on the left of this slide. The largest contributor to the increase in revenue is a good illustration of our key theme of recurring revenue growth. DARZALEX royalties grew more than 50% compared to the first quarter of 2019. Additional drivers for our Q1 revenue were milestones and reimbursement income related to additional partnership agreements. As well as increasing revenues, we also increased investment in our pipeline, in our team, and in our capabilities, as you can see on the next slide. On the graph on the left, you can see the major drivers of our increased investment in Q1.
In total, operating expenses increased by DKK 204 million, which was driven by the accelerated investment in our product portfolio, including the advancement of both epcoritamab and DuoBody-PD-L1 x 4-1BB, which together accounted for more than 80% of the increase in Q1. We've also spent more on expanding our very talented team. We have hired key team members to support our growing product pipeline, and we've continued to build our commercial and other capabilities. Our revenue growth outpaced the higher investment levels, driving DKK 71 million of operating income. Overall, this is a great illustration of the robust financial framework that I described earlier. Now, having looked at the individual parts, let's look at our Q1 financials as a whole. Here, you will see a P&L summary. In Q1, revenue came in at DKK 892 million, an increase of 51% compared to Q1 2019.
The increase was primarily driven by higher DARZALEX royalties. Total expenses in Q1 were DKK 821 million, with 87% being R&D and 13% G&A. Operating income was DKK 71 million compared to an operating loss of DKK 26 million in the first quarter of 2019, primarily driven by higher revenue. That brings us to the net result, where we reported net income of nearly DKK 269 million, compared to DKK 72 million in the same period last year. A strong Q1, both in terms of our overall numbers and DARZALEX sales. Of course, that preceded COVID-19. Let's turn to that on the next slide. As we enter Q2, we've started to see some softness in sales of DARZALEX. Clearly, patient visits have become more difficult, and some newly diagnosed patients are delaying the start of treatment.
According to IMS data, U.S. sales of DARZALEX on a gross basis are down around 15% to approximately $40 million per week, compared to the four-week average at the end of March. You know, sales in the rest of the world are a bit more challenging to unpack as they cover many countries being impacted by COVID-19, and our line of sight here is more limited. Given the seriousness of multiple myeloma, patients with active disease need treatment to avoid progression or worse. Patients who are foregoing treatment now will still need to be treated soon. On balance, we believe what we're currently seeing is likely to be a temporary delay rather than any fundamental disruption.
Based on the very strong clinical data of DARZALEX supporting the seven approved indications in the United States, as well as the approval of the subQ version last week, we currently expect that sales will recover in H2. Brings me to our guidance on slide 10. Despite some headwinds, at this stage, the guidance we issued in February remains intact. As a reminder, starting with the summary P&L, we expect our revenue to be in the range of DKK 4.75 billion-DKK 5.15 billion, driven by continued growth of DARZALEX. We anticipate our 2020 operating expenses to be in the range of DKK 3.85 billion-DKK 3.95 billion. This step up in investment reflects our enthusiasm for our pipeline.
Our project costs account for more than half of our total investment and are also driving more than half of the growth of our cost base. 87% of the increase in our project investment relates specifically to epcoritamab and DuoBody-PD-L1x4-1BB, the two programs we are looking to expand and accelerate in 2020. Putting all this together, we're planning for substantial operating income in 2020 in a range of DKK 0.85 billion-DKK 1.25 billion. Let's zoom in on DARZALEX. The key drivers underpinning DARZALEX's growth remain very much in place, notwithstanding COVID-19. The key drivers are, first, following the MAIA and other approvals in 2019, we expect further market share gains in frontline. Second, the recent approval of the subq formulation. We believe this approval is even more important given the clear advantages of subq delivery in the current environment.
Third, we anticipate continued strong market shares across all lines of therapy and geographies as DARZALEX gains further traction globally. For 2020, we anticipate that sales will continue to grow somewhere between 30% and 43% and be in the range of $3.9 billion-$4.2 billion. I'll move to my final slide. Clearly, in the short term, COVID-19 is affecting everyone's lives. In conclusion, I think in times like this, it's useful to take a step back and reflect on our business and financial position. We have a very strong foundation. We have great recurring revenues and they're growing, and we're using those revenues to invest in a really focused and disciplined way. We're investing in both our highly innovative and differentiated product pipeline, as well as the team to deliver it.
Especially important in today's environment, we've got a robust balance sheet, DKK 1.9 billion of cash at the end of Q1 and no debt. I'll turn it back over to Jan for an update on our 2020 goals.
Thank you, Anthony. Let's move to slide 12. We continue to anticipate robust progress across all areas of development during 2020. The most significant area of advancement is still expected to be with our own proprietary pipeline of product candidates, where we are responsible for at least 50% of development. Our extremely solid financial foundation will allow us to maintain the investment in our innovative proprietary products, unique next-generation antibody technologies, and capabilities that we laid out for you when we presented our 2020 guidance in February. Genmab remains steadfast and focused on our core competencies, and we will continue to use our world-class expertise in antibody drug development to create truly differentiated products with the potential to help cancer patients. Let's move to slide 10. That ends our presentation of Genmab's Q1 2020 financial results. Operator, please open the call for questions.
Thank you so much. Now, ladies and gentlemen, we will begin our question and answer session. As a reminder, if you wish to ask a question, please press star one on your telephone. Remember, please, there will be one question per participant. If you wish to ask another question, please press star one again. If you wish to cancel your request, please press the hash key. Once again, please remember that there will be one question per participant. The first question comes from the line of Trung Huynh from Credit Suisse. Please go ahead.
Hi, guys. Thanks for taking my questions. Trung Huynh from Credit Suisse. One question. I guess if you can comment on when you expect the launch of the subq dose and the price that's going to come in at versus the IV formulation. Thanks very much.
Hello, Trung. First of all, welcome. As a covering analyst, we greatly enjoyed your initiation report, so we are delighted to have you on the line. Let me comment on the launch. It will likely be next week in the U.S. It will be available, FASPRO will be available probably from Monday or next week. The price is up to Janssen, and it's very similar actually to the price of the IV dose of daratumumab, based on the average weight of a U.S. patient.
Excellent. Thanks very much.
Thank you.
Thank you. The next question comes from the line of Wimal Kapadia from Bernstein. Please go ahead.
Great. Thanks very much for taking my question. Wimal Kapadia from Bernstein. Following on from Trung's question, just want to get your thoughts on the subq launch during the pandemic. Is the impact from COVID-19 negative given that it's harder to get new patients started? Would you argue that actually the ability to get patients out of the clinic hospitals quicker will increase the launch trajectory? I'm just trying to think about the impact in totality. Maybe near term it's a delay, but longer term, for the rest of 2020, it actually may be beneficial. To get some thoughts will be great.
Thanks, Wimal, for the question. I will start off with this answer and then see whether Anthony Mancini can give further color. Let me start off with the question on the launch. Janssen is, of course, doing a completely virtual launch. In this era, it's impossible to have salespeople on the floor, basically, for launching DARZALEX FASPRO. We have already heard from bigger medical centers, Wimal, that they are training nurses right now in the U.S. Actually, the nurses have been trained to actually visit patients at their homes and actually inject them at home with DARZALEX FASPRO. This is initiated by the major medical centers in the U.S., and that could actually be a very significant positive impact on the use of DARZALEX, because as Anthony Pagano has already said in his introduction remarks, these patients need to be treated.
When you don't treat a multiple myeloma patient, Wimal, it doesn't end positively for the patient. They really need to be treated with drugs like daratumumab. I think by having available a very rapid three-to-five-minute injection, which can potentially be even given at home to patients, is a huge advantage, because if one considers that these patients are definitely many times in the risk category of being immunocompromised, they are elderly patients, because that is the population which gets multiple myeloma, Wimal. I think it is a huge advantage to potentially give it in a short time and at home. As I already said in my introductory remarks, the safety is just excellent of DARZALEX FASPRO. It seems to be better. Administration-related reactions are roughly two-third less basically than what they are with IV. I think this could actually be a benefit in the end.
Let me ask Anthony Mancini to see whether he can add further color on the launch of DARZALEX FASPRO in this era with coronavirus and infections threatening us all. Anthony?
Thanks, Jan, thanks, Wimal, for the question. I think Jan covered it pretty thoroughly. I think we're really enthusiastic about the potential for DARZALEX FASPRO, particularly in an environment where infusion centers have limitations. I think Jan covered the key point, which is, relative to sitting through a several-hour infusion, being able to give a fixed-dose, three-to-five-minute injection, we think presents significant advantages in addition to the consistent efficacy that DARZALEX FASPRO has with the IV formulation. I think those are the key advantages. The couple things that I would add are related to what Janssen has been able to do in terms of launch readiness, and enable practices across the U.S. to really flexibly learn about DARZALEX FASPRO, and whether they choose to do that through representatives, MSLs, or nurse educators, or whether they choose to do that through non-personal approaches.
The team is ready. The product, as Jan mentioned, will be available as early as next week. The other thing that Janssen has done is they've amended all company-sponsored clinical studies of daratumumab to allow patients to switch from the IV formulation to the subcutaneous formulation if there is a patient and physician desire to do so. That will enable the team to collect really important safety data and patient preference data in these studies. That's, I think, where I'll leave it, Jan.
Thank you very much, Anthony.
Thanks, Wimal.
Thank you. The next question comes from the line of Michael Schmidt from Guggenheim. Please go ahead.
Hey, guys. Thanks for taking my questions. I had a pipeline question regarding epcoritamab, the CD20 DuoBody. We saw that you have the upcoming ASCO presentation. I was just wondering if you could help us understand what the expectations should be with respect to this update, maybe relative to the recent ASH data and how the profile of this product has evolved in recent months.
Thanks, Michael, for the question. We are delighted to give you some further color. We have actually progressed a few more dose levels, Michael, versus what you saw at ASH. We, of course, also followed up the 12-milligram dose where you only saw very early data in different patients and added further patients at that cohort. You got a pretty substantial dataset there with different dose cohorts. We are rapidly moving to know the recommended phase II dose, Michael, and then start expansion cohorts in the coming time. We remain very positive about the profile of epcoritamab. Also, the safety looks very solid, very much in line of what you have seen at ASH. Finally, we are very busy finding a partner for epcoritamab, and we are actually very enthusiastic about the level of enthusiasm by pharma and biotech companies.
We are very much on top of that project. Despite the challenges of the COVID-19 era, Michael, we think that we can deliver by mid this year, if not earlier, with a very important partnership. The most important points for Genmab are that we actually hold on to 50% of the product rights, we share 50% of the costs, and we actually are booking sales in the U.S. and actually have co-commercialization rights in other territories which we are interested in. I think we will get that from the current discussions. We are super excited about moving epcoritamab further into the B-cell therapy area and remain enthusiastic, and the rest will come at ASCO, potentially.
Can I just ask one follow-up, maybe just how many additional patients worth of data you might have at ASCO relative to ASH, just to get a sense of that?
No, we haven't disclosed that, Michael, and we are still in the midst of following up on that data. Cannot give you the number, but we've added a few more dose cohorts, and we have done backfilling of the cohorts, like 12 milligrams, where you've seen the initial data of. I cannot give you the exact number, but it will be a very nice number of patients. What is also good, Michael, is that despite the challenges, of course, of recruiting patients in this COVID-19 era, I can tell you that the doctors have been very enthusiastic about moving patients into this study, this Phase I/II study.
Because these patients are very heavily pretreated and they really need new treatments, we have actually treated patients with many rounds of prior treatment. I think the enthusiasm level of the doctors and the willingness of the patients to participate in the trial, I think make us quite enthusiastic about the potential of that product. I think I should leave it with that.
Great. Looking forward to seeing that. Thank you, Jan.
All right. Thanks, Michael.
Thank you. The next question comes from the line of Peter Verdult from Citi. Please go ahead.
Yes, thank you. Peter Verdult, Citi. A somewhat left field question, if possible, for Anthony. We don't often talk about TEPEZZA in detail on the conference call. Horizon today raised expectations just for this year alone, to in excess of $200 million. I think current consensus is around $30 million. I just wanted to understand that a 5% royalty is the right way of thinking about Genmab's economic interest in this asset. Am I right to assume that sort of level of sales is not built into current guidance for Genmab, i.e., TEPEZZA generating over $200 million in its first year of launch? Thank you.
Anthony, I think you can take this. Anthony Pagano?
Sure. Yeah, sure. Thanks for the question, Peter. First of all, we're very encouraged by what we heard from management of Horizon today about their comments on Q1 and the performance in Q1, as well as their comments around 2020. Stepping back, it's also great to see that at least it seems that Tepezza is providing a needed treatment option for patients with TED. In terms of the financial impact to Genmab, and given also the comments today from Horizon, we'll take that back. We'll digest it. As a reminder, we do have a mid-single-digit royalty here. As it relates to our guidance, for 2020, we haven't given specific guidance. Just to orient everyone, we've included royalties from Tepezza, any potential royalties from Ofatumumab and other income in our guidance for 2020.
Have not given specific guidance for TEPEZZA. I guess my sort of last comment, as I mentioned, I was very encouraged on what we heard from Horizon today. I think that does bring us back to our financial framework and one of the key pillars there being the recurring revenue growth. Obviously, we're encouraged about what they said about 2020, but also just more broadly moving forward, we're excited about adding another recurring revenue stream to our overall financial profile. I think I'll leave it there, Peter.
Thank you. Thank you very much.
Sure.
Peter, I can give you something extra. What Horizon Therapeutics also said today, which was also new to us, is that they were actually investing in two new development programs with TEPEZZA. One is in fibrotic disease, and the second one is in a subcutaneous formulation for Graves' disease patients with Graves' eye disorder. I think that is potentially a very nice way to further broaden and optimize the market for TEPEZZA. As Anthony Pagano already said, Peter, we will happily enjoy the income and then invest it in our own differentiated product pipeline. All in all, good news today on TEPEZZA, and this is only the beginning.
Thank you. Sounds good.
You're welcome.
Thank you. The next question comes from the line of Kennen MacKay from RBC Capital Markets. Please go ahead.
Hey, thanks for taking the question and big congrats on the quarter. This was really a very quite strong DARZALEX quarter. I was wondering if you could sort of give us a sense, a little bit more granularity for what drove the quarter-over-quarter growth. Was that increased uptake in first-line or deeper penetration in second-line? Then, hoping maybe you could elaborate a little bit on what your ambitions are for subcutaneous DARZALEX as maybe a portion of total DARZALEX, maybe by sort of the end of the year, just so we can get a sense of how you are thinking about this product. Thanks so much, and congrats again.
Thanks, Kennen. I will hand over this question to Anthony Pagano. Then I can potentially add to that. Anthony?
Yeah, sure. Thanks, Kennen, for the question. I mean, overall, I think we're very pleased with what we saw in Q1 in terms of DARZALEX performance, the $937 million, as you've seen, looking at the sort of the quarter-over-quarter growth rates. We had very strong growth at broadly 13% on a consolidated basis. Looking at the U.S., it came in at 4% and 23% for rest of world. I think as we look across the different data points, there really isn't anything that jumps off the page at us in the U.S. As I mentioned, some of the weekly sales figures we're seeing in the U.S. prior to COVID-19 were really trending in the right direction. Overall, we have some really strong and nice market shares in the U.S., and are looking forward to gaining further traction in frontline.
Also, we feel that DARZALEX FASPRO will be a game changer for both patients and physicians. In terms of the rest of the world, here, as I mentioned, our line of sight is a bit more limited. Of course, it's a mosaic of many different countries with different DARZALEX regimens approved and reimbursed. The only thing I can really kind of point to here is some bits and pieces of some market share data that we are looking at as we exited Q4. We're really looking pretty strong. In that respect, we're really pleased with what we saw overall for DARZALEX, also what we saw in terms of the rest of world performance in Q1 and growth. Jan, you want to add something there?
Sorry, I was on mute. I think we will leave it with that. The second question was, of course, the conversion to the subcu formulation. What we understand is that Johnson believes that many patients will actually be switching to the subcu in time. To give actual numbers is very difficult, especially given the coronavirus era, Kennen. I think that could actually accelerate the conversion rate to subcu. DARZALEX pricing is roughly similar, as we have heard from Janssen. I think the convenience and the potential even better safety of the subcu formulation can really help, especially in times like this, to really accelerate that conversion rate. We prefer not to give you percentages here, so you have to do your own modeling, Kennen, and we will happily read that tomorrow.
Fair enough. Thank you.
Thank you.
Thank you. The next question comes from the line of Robert Burns from H.C. Wainwright. Please go ahead.
Hi, guys. Thanks for taking my questions, and congrats on the quarter again. My question is directed more towards Anthony. In prior quarters, you've sort of given us what the market penetrations were by the end of the quarter. I was curious what you're seeing with regard to those market penetrations towards the end of the first quarter and where they currently sit. Thanks.
I think Anthony can give you color on that on the basis of the brand impact data. Anthony Pagano?
Yeah, sure. Happy to take it. Thanks for the question, Robert. Overall, as I mentioned, you sort of step back and think about DARZALEX, really happy with the overall performance globally. In terms of the actual brand impact data, remember, this is sort of survey data, and really encouraged about what we're seeing broadly as we exited Q1. A couple of the key figures I'd highlight for you would be looking at the overall market share being at 22% and overall share of new patients growing to 26% compared to 23% at the end of December. Front line, we've seen some improvement there, going from 8% in December to 9% in March. New patients in front line, we did see some improvement from the 12% where we were at in December, both in January and February, but we did see a bit of a drop off back to 12%.
Kind of flat there in terms of first-line new patient starts. The rest of it, in terms of second-line, third-line, and fourth-line, I think no matter which number you look at, we've seen very strong growth in terms of market shares. Maybe the one I would highlight would be second-line growing from 36% in terms of total market share, second-line patients up to 38%. In terms of new patient starts, going from 45% in December up to 46%. I think that gives you an overall good picture of what we were seeing. I think you saw similar trends both in third and fourth line. What was really kind of jumping off the page at us, I think it's, again, just one data point, were the new patient starts both in third and fourth line increasing.
First of all, in terms of the 3rd-line patients, going from 43% up to 55%, and then 4th-line going from 29% all the way up to 40% in March. I think we've seen overall what I would characterize as continued market share gains and really nice growth.
Thank you, Anthony.
Thank you.
Thanks, Robert.
Thank you. The next question comes from the line of Matthew Harrison from Morgan Stanley. Please go ahead.
Hi, Jan and Anthony. Thanks for taking the question. This is Connor on for Matthew. You touched on both of my questions briefly, but I just wanted to press a little bit more. Could you just provide a little bit more detail on your status of the partnership for CD3xCD20. You mentioned maybe an update mid-year, but I guess, is that all you guys are willing to disclose at this point? Have they progressed at all since earlier in the year? Just quickly, now that SubQ is approved in the U.S. and on track in the EU, how quickly do you expect patients to be transitioned over from the IV drug, and I guess the impact of COVID to that transition? Thank you very much.
Thanks very much for the questions. I cannot give you a lot of extra color on the partnership process for epcoritamab, apart from telling you that it's going really, really well. It's not impacted by COVID-19 at all. We have lots of video conferences, telephone conferences, and also some physical meetings with potential candidate partners. We're very, very optimistic that we can actually close a very good partnership by mid this year, if not earlier. It's always difficult to estimate, of course, what the timing will be, because there's lots of paperwork to be done. We are very rapidly progressing. What is important, actually, to say here that this will not impact the expansion of epcoritamab, because we are really progressing rapidly with the clinical trial. We're going to very soon add expansion cohorts.
We are going to start a few more studies, that could potentially also include one or more phase III study before the end of the year. We are already speaking very actively with the candidate partners about how to expand those plans. We will not actually let the coronavirus troubles hinder that, because we actually think that we can turn this era into an advantage potentially for Genmab and for the partner for epcoritamab, because we know that some of the large phase III trials from competing programs like the Roche CD3xCD20 bispecific programs are on hold right now, whereas we are still recruiting patients and planning new studies. We are very aggressively and proactively moving into that. That's my first priority project to really get done. That's about all we can say, I think, at this moment on the partnership progress.
We are very, very enthusiastic about progress and reception. The conversion from IV to subcu is very difficult to predict, but we actually believe, and also I think Janssen believes, that the Coronavirus situation will actually help us to go for even more rapid switching from the IV to the subcu formulation because the advantage is so massive. For patients, there will be at roughly the same out-of-pocket cost for most of the patients, I understand from Janssen. To have only a five-minute injection rather than a three-and-a-half-hour infusion in times that people are worried about getting contaminated with Coronavirus and then potentially getting into real trouble, especially because these elderly cancer patients are many times immunocompromised because of the treatment with other drugs. I think this is a huge advantage, and I think that could actually accelerate the conversion from the IV to the subcu formulation.
We haven't really publicly spoken about the percentages we use internally, but it could be very rapid, we believe. Coronavirus infections could actually facilitate the switching. That's where I want to leave it at.
Great. Thank you.
Thank you.
Thank you. The next question comes from the line of Emily Field from Barclays. Please go ahead.
Hi. Thank you. I was just wondering if you would comment if your guidance assumes much of a contribution in the transplant population based on the CASSIOPEIA data, and if you had an update on sort of the plans with the GRIFFIN data. I know that you talked on the last call about Janssen looking to have that included in the NCCN guidelines. Just any updates there would be great. Thank you.
Thank you, Emily. I will take the second question, then the first one I will pass on to Anthony to speak about contribution of the transplant-eligible population in our modeling and the guidance. The GRIFFIN data have actually been published recently in Blood, Emily, we can give you the link or the exact reference of that paper. I think has been submitted to the compendia in the United States. I think Janssen is trying to get it into the compendia listings mid this year. That is, I think, super important for the Dara-VRd combination therapy. Of course, also both of the phase III, which test Dara-VRd in the transplant-eligible and the transplant-ineligible populations are also fully recruited, and we expect that that data from the PERSEUS and CEPHEUS studies will also be used to actually get it formally in the label for daratumumab.
I think as it relates to GRIFFIN, I think we are progressing towards hopefully a compendia listing very soon, and hopefully at least the ability of doctors to decide on whether they want to use that. Janssen cannot promote for that. Maybe to Anthony Pagano for the CASSIOPEIA data, how far that was actually in our models for pickup this year.
Yeah. Thanks, Emily, for the question. Look, overall, our guidance of DKK 3.9 billion-DKK 4.2 billion for the year covers a number of different sort of positive contributors and key drivers, which I sort of summarized on the call. Just to summarize again here, key one is obviously following MAIA and other approvals in 2019. We expect further market share gains in frontline. As I went through some of the market shares, I think we are starting to see some of that and certainly would expect and hope for more as we progress throughout the course of 2020. We talked a lot today, second driver, subcu formulation. Third, I think is more broadly, I think as we sort of just really do believe as we move forward into 2020 and beyond, that DARZALEX is going to gain further traction globally.
This is going to be continued strong market shares across all lines of therapy and geographies. Emily, I'd love to give you some more detail, but we really haven't given that level of guidance as it relates to the sort of individual parts as our guidance for $3.9 billion-$4.2 billion. Overall, I think, we do expect further gains in frontline.
Thanks, Anthony.
Thank you.
Thanks, Emily, for the question. Yep.
Thank you. The next question comes from the line of Sachin Jain from Bank of America. Please go ahead.
Hi, Sachin Jain, Bank of America. Just two quick questions. I wonder if you could just update on timing for some of pipeline data for some of the other assets. In particular, AXL ADC and 4-1BB, just when should we expect updates on those? Just secondly, sorry, Jan, just go back to partnering. I want to just try and tweak out some more.
Yeah.
Are you still running discussions with multiple partners, or have you singled it down to a single player? You've been very clear on what's important to you in terms of U.S. co-promotes, et cetera. How important is the upfront payment, and is that still a delta in your mind? Thank you.
Thanks, Sachin, for the questions. As it relates to timing for other data, I can tell you that the PD-L1x4-1BB data will be in the second half of this year. Epcor will, of course, be at upcoming ASCO data. For tisotumab vedotin, we expect the top-line data from the potentially pivotal cervical cancer study to be either at the end of Q2 or very early in Q3. The other data we haven't given the timings on, but AXL-ADC will very likely be in the second half session of this year. As it relates to partnering, this is, of course, a key topic of interest for all of you.
I can tell you that we are still speaking with multiple parties, we actually are most aggressively moving forward with one of the parties now to hope to push it towards a close in the coming time. We are focusing and prioritizing one partner now very strongly at this moment. As it relates to the upfront payment, I've always said that, well, it's more important to do it as a true 50/50 partnership session and to be able to book sales in the U.S. and potentially other territories where we are very interested in. I flagged up Japan as a territory, which is also important for tisotumab vedotin for Genmab, where it makes sense to have a commercial presence. The upfront in that context is less important.
However, since it's such a competitive process, and this is a very actively searched and looked after asset, I think the market can also foresee to get a very impressive upfront also in this potential deal. That's where I really need to leave at that Sachin.
Very clear. Thank you, Jan.
Thank you.
Thank you. The next question comes from the line of Peter Welford from Jefferies. Please go ahead.
Hi. Yes, thanks for taking my question. It's really just a more general question in terms of, you mentioned PD-L1 4-1BB and Aptamer and the AXL, as well as, I guess, I'm thinking the DR5. I'm just wondering with regards to these ongoing phase I, II studies, what you're doing special, if you like, or what measures you've put in place to continue patients being enrolled and followed up in these sorts of studies, given the current COVID-19 disruption. We've heard from a lot of pharma companies where a lot of trials that are fully enrolled or trials that are late stage are managing to stay on track, but it's a real challenge to enroll patients and follow up in earlier stage studies. I wonder if you can comment on that at all from your perspective. Thank you.
A very good question and very pertinent as it relates to the COVID-19 era, Peter. I can tell you it varies a lot from trial to trial. I can tell you that the two most important studies for Genmab right now are the ones with epcoritamab, which is still recruiting patients as we speak. I already referred to that earlier on in the Q&A. Also the DuoBody-PD-L1x4-1BB in solid tumors. I've said in my introductory words and also in the Q1 reports that we already started an expansion cohort. That means that we have already determined the recommended phase II dose. They are very rapidly. Remarkably, doctors are still very eager to put patients into that trial, also new patients, and the same holds for epcoritamab.
For some other studies, it's more difficult, as you rightly say, because then in some hospitals, actually new patients recruitment is very difficult. We still believe that the overall impact on our studies is rather minimal up to now, Peter. Actually, patients on treatment with our experimental drugs are being treated as we speak. New patients are in some hospitals not allowed to be recruited because priority needs to be given to the coronavirus-infected patients. The two most important studies are rather unimpacted at this moment. What we do is a lot of monitoring via the internet, via digital systems. We cannot visit some of these sites ourselves. We have actually changed our way of working to actually made a number of procedural changes in order to be able to follow and document and monitor patients in our clinical trials.
It may not all be bad, Peter, which comes out of this coronavirus crisis. I think we actually can potentially even more effectively work with patients in multicenter trials. For Genmab, we're now speaking about, I think, 11 studies in 15 countries at 150 clinical sites, to give you a feeling for the complexity. For many of these studies, we actually do a lot more digital monitoring. Also the regulators, both in Europe and in the U.S., are actually quite proactive in allowing you to actually do that. We all have to see how this in the end pans out. Our way of working may be, I think, forever different after this coronavirus crisis. That's probably where I need to leave it at at this moment. During the year, Peter, we'll give you updates, of course.
What we hope is that in some countries, actually, we begin to get control over the situation, like Denmark. We have actually, as of end of April, started to repopulate the offices of Genmab again in a very gradual manner because the health authorities and the government there believe that it's safe. In Utrecht, we are now going to scale up the lab activities for Genmab personnel in time, in the coming time. We have kept our critical projects running also during the crisis. We are now trying to bring as many people as possible back to the offices of Genmab in a safe way, also adhering to social distancing and other procedures to keep our employees and collaborators safe. I think it seems to be moving in the right direction, Peter.
Also as it relates to clinical trials, I think that will also then again accelerate some of the clinical studies, because don't forget that most of our studies are in cancer patients, and we're trying to help these patients actually with experimental therapeutics. One I want to mention here especially is a BMS program where we actually have an antibody created by Genmab targeting IL-8, HuMax-IL8, which is right now being tested in cancer patients with coronavirus disease to really see whether it can help those poor patients who have double bad luck. One, first the cancer, and then second, coronavirus infection. I'm very thrilled to mention that study, and I hope that very much for the patients and for BMS that HuMax-IL8 can actually help those poor patients doing better with their disease. That's probably where I need to leave it at.
Thank you. The next question comes from the line of Michael Novod from Nordea. Please go ahead.
Yeah, thanks a lot. Just a single question to Mancini . The data reads out sort of in early Q3 as guided by Seattle. Maybe you can just remind us where you stand in terms of scaling up the entire commercialization organization and all that now you're also building a strong organization also with the new chief operating officers. Maybe just a reminder of where you're standing when you get the data.
Thanks very much, Michael, for the question. Yes, data end Q2, early Q3 because data cleaning is actually more challenging now in the coronavirus era. That is basically behind that potential small or minimal delay, but we are very much on track to come with the data. I am actually pleased, Michael, to hand over to Anthony Mancini, who has a very robust commercial experience. Almost 24 years at BMS with multiple products, also cancer products. Why don't we ask Anthony to give a short peek into how we are building up the commercial organization for TIVDAK, epcoritamab, and potential other products like DuoBody-PD-L1x4-1BB. As a reminder, Genmab will also lead the worldwide commercialization of that product with some limited co-commercialization rights for BioNTech or 50/50 partner for that program. Anthony Mancini.
Thanks, Jan, thanks, Michael, for the question. I think Genmab and Seattle Genetics are really working closely together on launch readiness for tisotumab vedotin and really focused on the first potential indication in the second line metastatic cervical cancer setting. We're working hard to jointly build launch strategies and plans, and as has been shared previously, obviously, it's a collaboration agreement that's in place, sharing costs and profits 50/50. As we advance launch readiness and as Jan pointed out, we start to see data late the second quarter and early in the first quarter, we'll start to share a little bit more about how we'll execute on a country-by-country basis going forward. Our focus is to make tisotumab vedotin a success and from a Genmab perspective, have a presence in the U.S. and Japan.
Great. Thanks, Anthony. What we will do is we'll actually update you, Michael, during the year on the expansion and the further structuring of our commercial organization that will come in line with the data for tisotumab vedotin and the further plans for epcoritamab. What I also want to flag up here is that we have a capital markets day on November the 13th. Let's hope that we can all fly, Michael, or at least log in onto that meeting, where we actually want to give you a far greater color and insight into how we are going to build up and expand our commercial organization in a very clever way. We want to be as innovative here as we are in the rest of our business, and I think this is super exciting times, Michael.
I think for Genmab, this is only the start and the best is yet to come.
Thanks.
Thank you.
Thank you. The next question comes from the line of Asthika from Goonewardene. Sorry for that. Please go ahead.
Hi, guys. Asthika Goonewardene from SunTrust. Jan, thanks for taking my question. Jan, on the last quarter call, you teased us a bit, you said that 1046, that you've seen some initial efficacy signals in checkpoint inhibitor failed patients. I'm wondering if you're willing to tease us a little bit more and tell us now that you got a few more doses out there, you've seen a few more of that. If I can just squeeze in a couple of other quick ones here. For 3013, how important is CLL to the discussion with the partners, were you hoping to share any first looks of 3013 in CLL with your potential partners before inking the deal? Lastly, was the rest of world growth of Dara in one Q in any way helped by one of those one-time large purchase orders?
We just noticed that every second quarter, you seem to get a bit of a bump from something like that in the J&J numbers, and I was just wondering if that came in a little bit early this year into the Q1.
Thanks, Asthika. You sneaked in a few more questions, that's, I think, okay with me. PD-L1/4-1BB, we have definitely treated on more patients than at the full-year results in February. I cannot give you further data apart from saying that we and BioNTech are super enthusiastic about what we see clinically with early signals in patients, including patients that have already been treated with checkpoint blockers. With solid tumors, we now have started the first expansion cohort at the recommended phase II dose. We're very excited, and we have to await Asthika data until second half when we present them at the medical conference. Unless, basically BioNTech and us decide to release some data in the public domain, we need to do that in a coordinated manner. As Anthony Pagano has already said, we are super excited about expanding that program.
From that, you can already infer that we are really quite pleased with what we see there with that program. I need to leave it with that. With the epcoritamab program, CLL is very important because we think that actually, better treatment of CLL potentially in better and more efficacious regimens which are without chemotherapy. Combinations of epcoritamab and potential small molecule drugs are of high interest to us and potential partners, so we are discussing that. We don't have any clinical data there, but we believe that based on the preclinical data and the potential synergies we have seen already in preclinical studies, Asthika, this is a very attractive target indication. Yes, we have already, together with potential partners, planned follow-on clinical studies also in CLL, and we believe that's an important area to move into.
As it relates to the rest of the world's data in Q1 for daratumumab, I believe there were no one-time benefits, basically. I will ask Anthony Pagano to give you some further color on the rest of the world's data, because you're right, Asthika. Last year, we did benefit in Q2 from a one-off, but I believe that was not the case in Q1 this year. I will ask Anthony Pagano to comment on that.
Sure. Yeah. Thanks, Jan. You're right. Absolutely. First of all, really happy with the growth in Q1 globally. Rest of world, a strong performance in the 23% quarter-over-quarter growth. Look, there really wasn't anything of any material nature. Just to try to give you a bit of additional color and be helpful, there was a small favorable impact, really some normal timing shifts of tenders in some of the emerging markets. Again, it's really a small contributor. We're talking very low single digits in terms of the growth. Really, again, this was more so in the spirit of trying to be full and complete. Overall, nothing material at all in Q1. It certainly doesn't change the overall picture, and it was not a primary driver of the excellent growth we saw for the quarter.
Again, as I said overall during my remarks, we looked at Q1 as being a really strong quarter for DARZALEX, but also for our overall financial results.
Thank you, Anthony.
Thank you so much for the color, guys.
Thank you.
Thank you. The next question comes from the line of Laura Sutcliffe from UBS. Please go ahead.
Hi. Thank you. Laura Sutcliffe at UBS. Could you update us on any progress that you've made with the selection of clinical candidates from your HexElect platform? Maybe just secondly, if I can, I think your press release has some quite general language in it relating to coronavirus and sort of potential risks from that. I think there is a point where it says something about impact to regulatory approval timelines. Is that intended as very general, or is there something specific that you're getting at there? Thank you.
Thanks, Laura, for the questions. Let me start with the HexElect question. We have actually a number of potential clinical candidates selected, Laura. They are not in the public domain. We actually decide to only give you those candidates from the different platforms when we have formally scheduled an IND filing and a CTA filing. Another fact is that I don't get any credit from you all when I flag up exciting candidates with our new next-generation platforms, when the timelines are not concrete. To make it worse, Laura, once I would stop such programs, I would be punished and beaten up, basically, at the moment that I give up on a program like that, which is, of course, also part of our business of only forwarding the best and potentially first-in-class differentiated molecules.
Very likely at the November R&D day, on November the 13th, Laura, you will get some further insights into HexElect and the type of targets which we have selected to work on going forward. As it relates to epcoritamab coronavirus impact, maybe Anthony Pagano can give further color on that.
Yeah. Thanks. Yeah. Maybe Laura, if you don't mind, would just repeat the question? I didn't quite get what you're sort of looking to give some more color on there.
Sure, yeah. It wasn't an epcoritamab question. It was just a question about the language in your press release. I think one of the things you highlighted around sort of potential coronavirus disruption was the potential for impact to regulatory approval timelines. My question is there something specific that you're getting at with that or not?
Yeah. Certainly would welcome comments from Jan, but no, I think this was sort of just more of a general risk, not anything in particular that's sort of worrying us too much at this point in time. Jan, anything you'd like to add to Laura's question?
No, absolutely. I agree with you, Anthony. No, this is a general qualifier, Laura. I think coronavirus can, of course, impact the regulatory timelines of a number of programs. I think this was just meant as a general indicator, basically, of risk conferred by the era with coronavirus infections, but nothing specific for any of the programs at this time.
Okay. Thank you.
Thank you.
Thank you for your participation. We have run out of time. We have to end the Q&A session now. Speakers, please go ahead.
All right. Thank you for calling in today to discuss Genmab's financial results for the first quarter of 2020. We hope that you all stay safe, keep optimistic, and remain healthy. We very much look forward to speaking with you again soon.
Thank you so much. That does conclude our conference call today. Thank you for participating. You may all please disconnect. Speakers, please continue to stand by.