Genmab - Q2 2023
August 3, 2023
Transcript
Operator (participant)
Hello, welcome to Genmab's Q2 2023 financial results conference call. As a reminder, this conference call is being recorded. During this telephone conference, you may be presented with forward-looking statements that include words such as believes, anticipates, plans, or expects. Actual results may differ materially, for example, as a result of delays or unsuccessful development projects. Genmab is not under any 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 would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead.
Jan G. J. Van de Winkel (President and CEO)
Hello, welcome to Genmab's conference call to discuss our financial results for the period ending June 30, 2023. With me today to present these results is our CFO, Anthony Pagano. For the Q&A, we will be joined by our Chief Development Officer, Judith Klimovsky, and our Chief Operating Officer, Anthony Mancini. As I already said, we will be making forward-looking statements, so please keep that in mind as we go through this call. During today's presentation, we will reference products being developed under some of our strategic collaborations, and this slide acknowledges those relationships. In May, Epkinly became the first T-cell–engaging bispecific antibody approved for use in the U.S. for third-line plus diffuse large B-cell lymphoma.
With this approval, we achieved an important milestone, both for Genmab and, most importantly, for patients with third-line plus diffuse large B-cell lymphoma, who are in need of an innovative treatment option administered subcutaneously. Our teams, along with our partner, AbbVie, were in place and fully prepared prior to launch. Now they are actively engaging key stakeholders, and we are encouraged by the overall positive response we have received as we deliver Epkinly to appropriate patients. We look forward to the potential for additional opportunities for Epkinly as we work with AbbVie to progress development into a variety of patient populations and treatment settings. The third-line plus diffuse large B-cell lymphoma indication is the first step to potentially establishing Epkinly as the core therapy across diffuse large B-cell lymphoma, follicular lymphoma, and beyond.
Epkinly's approval is also a testament to our team's dedication to turn novel science into medicine, and to develop differentiated antibody therapeutics with the goal of improving the lives of patients. It is the third approved therapy to be developed using our proprietary dual-body technology, and overall, it's the seventh medicine based on our innovation. I would like to thank the patients and investigators who took part in the EPCORE NHL-1, trial. That was the basis for this approval. Our partners at AbbVie for their excellent collaboration and the unstoppable team at Genmab, responsible for the discovery, development, and now commercialization of Epkinly. Let's now turn to our other recent highlights. In June, we announced that Epcoritamab has been added to the NCCN guidelines for B-cell lymphomas with a Category 2A designation.
As these guidelines are an important resource for providing U.S. healthcare providers with the information they need to make optimal treatment decisions, we were pleased that they were updated to include epcoritamab so soon after approval. Looking beyond the U.S. approval, we were pleased to announce in July that AbbVie received a positive opinion from the CHMP, recommending the conditional marketing authorization of epcoritamab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. If approved, epcoritamab would become the first and only subcutaneous bispecific antibody, conditionally approved in Europe as a monotherapy in this indication.
As I mentioned, together with AbbVie, we are advancing a robust clinical development program for epcoritamab across B-cell malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. To this end, also in June, we announced positive top-line results from the follicular lymphoma cohort of the phase 1, 2 EPCORE NHL-1 trial. The results showed an overall response rate of 82%, which exceeded the protocol's pre-specified threshold for efficacy. The observed median duration of response was not reached, and no new safety signals were observed.
These results are encouraging for patients with relapsed or refractory follicular lymphoma that are in need of new treatment options, and based on the data, together with AbbVie, we will engage with global regulatory authorities to determine next steps. The full results will be submitted for presentation at a future medical conference. As we noted last quarter, we had data presentations at a number of recent medical conferences covering a variety of our investigational antibody therapeutics, including epcoritamab....
We also continued to grow our pipeline last quarter with an IND submission for GEN3017, or DuoBody CD3/CD30, which has potential in hematological malignancies. Turning to other programs that incorporate our innovation, last month, Janssen announced that they had received positive CHMP opinions for both Talvey or talquetamab and Tecvayli, both of which were created via our DuoBody platform. The CHMP recommended conditional marketing authorization for Talvey as monotherapy for patients with relapsed or refractory multiple myeloma, who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.
The CHMP also recommended the approval of a type two variation for teclistamab, providing a reduced biweekly dosing schedule of one and a half milligram per kilogram every other week in patients who have achieved a complete response or better for six months or longer. Darzalex also continues to redefine the treatment of multiple myeloma. As you have seen, J&J's net sales for DARA were up 22% over the first half of 2022, and that is generating DKK 4.9 billion in royalties for us, contributing materially to our robust financials. I will now hand over the, the call to Anthony Pagano, who will take you through our first half 2023 financial results. Anthony, the floor is yours.
Anthony Pagano (EVP and CFO)
Great. Thanks, Jan. We continue to strengthen our foundation over the first half of the year. Of course, top of mind for everyone is the FDA approval of Epkinly. As we'll see, our financials continue to be strong. Recurring revenues grew by 27% in H1. This was principally driven by strong royalties from Darzalex and other approved medicines. Our solid balance sheet, growing recurring revenues, and significant underlying profitability allow us to continue to invest in our business and our pipeline in a very focused and disciplined way. An important part of this has been to continue to build the team and capabilities that we need to succeed. Let's take a look at those revenues in a bit more detail. We saw robust performance for Darzalex in H1. As you can see in the chart, overall, net sales grew by 22%.
That's net sales of nearly $4.7 billion, which translates to over DKK 4.9 billion in royalty revenue. Darzalex remains a key driver of our revenue. In H1, we grew total revenue to over DKK 7 billion, and as I've already highlighted, that included a 27% increase in our recurring revenue. To be clear, that's on a reported basis. Excluding some minor FX headwinds, recurring revenues grew by 30% on an operational basis. As a reminder, last year's H1 results make for a somewhat tough comparator, given that in 2022, we had significant FX tailwinds, and this is primarily related to the benefit from the Darzalex currency hedge rate.
The strong operational growth in H1 for this year was driven by higher Darzalex royalties, as well as royalties from other products. Taken together, this really illustrates the power of our recurring revenue. In Q2, we also recognized net product sales for Epkinly, and we're pleased with how the initial launch is progressing so far. It's, of course, super early days at this stage, so we shouldn't draw too many conclusions from a single month of sales. Nevertheless, we remain excited by Epcor's potential to transform the lives of patients. As we said, we're taking our strong recurring revenue and investing in a highly focused way, as you can see on the next slide. In line with our significant growth opportunities, total OpEx grew 45% in H1. In R&D, we've accelerated our investment into our product portfolio, especially the advancement and expansion of Epcor and other pipeline projects.
We've also further strengthened our team to enhance our commercial capabilities and support our expanding pipeline. Of course, that includes the launch of Epkinly. Now, let's take a look at our financials as a whole. Here you can see our summary P&L. Revenue came in at over DKK 7 billion. That's up 34% on last year. As mentioned, that's negatively impacted by a small FX headwind. Total expenses were DKK 5.1 billion, with 70% being R&D and 30% SG&A. Even with this increased investment, we're still delivering over DKK 1.9 billion of operating profit. Moving to our net financial items. Here, we have a gain of DKK 75 million so far in 2023, and this is driven by 2 partially offsetting items.
First, we've got the weakening of the US dollar against the Danish kroner. That's negatively impacting the value of our cash and investments. On the other side of the ledger, we have an increase in interest income due to higher effective interest rates. We have tax expense of DKK 426 million, which equates to an effective tax rate of 21.2%. That brings us to our net profit of nearly DKK 1.6 billion. As you can see, strong financial performance for H1. With that, let's take a minute to revisit our robust financial framework. First off, our revenue profile on the left. With the approval of Epkinly in May, we now have seven products on the market that are generating significant recurring revenues.
We see a clear path to potentially expand the number of approved products with the potential approval of Janssen's talquetamab. Taken together, we expect significant cash inflows for the years to come. Moving to the right, we remain focused in our investments as we evolve our organization for continued success. At the top of the list is accelerating and expanding Epcor, but that's just one of the exciting opportunities that provide us with a compelling rationale for increasing investment. As we've told you before, if we want to seize these meaningful opportunities, we've got to invest, and that's exactly what we're doing. With that background, let's take a look at our guidance. As you will have seen, we updated our 2023 guidance last week.
We now expect our revenue to be in a range of DKK 15.5 billion-DKK 16.5 billion. That's an increase to both the bottom and top end of our range. This increase is driven by continued strong recurring revenue growth, including higher total royalty revenues from Darzalex and other marketed products. For Darzalex, following strong H1 performance, we've increased the low end of our guidance for net sales and now estimate a range of $9.8 billion-$10 billion. Turning to our investments. As always, we remain focused on executing against our strategy and key priorities, and at the same time, creating long-term value. We're investing to capture the significant opportunities in front of us. Here, we're increasing our OpEx guidance to a range of DKK 10.4 billion-DKK 10.9 billion.
This is primarily related to increased and accelerated investment in Epcoritamab and the progression of other pipeline products. More specifically, for Epcor, our higher investment reflects increased and accelerated dose optimization work to potentially achieve a best-in-class profile. We are also accelerating our investment for our frontline trial in FL. As you know, this is a significant value driver for the Epcor franchise, and we're doing everything we can to accelerate this opportunity. Putting all this together, we're on track to deliver another year of substantial operating profit in a range of DKK 4.5 billion-DKK 6 billion. Finally, as a reminder, note that these projections are based on an assumed US dollar, Danish kroner exchange rate of 6.8. Now, let me provide a few closing remarks. In summary, we've had a very solid H1.
We've created growing recurring revenue streams, including now two of our own products on the market, 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 to capitalize on the very significant growth opportunities in front of us. On that note, I'm going to hand you back over to Jan.
Jan G. J. Van de Winkel (President and CEO)
Thank you, Anthony. In the first half of 2023, we continued to work towards our 2030 vision, where our KYSO antibody medicines are fundamentally transforming the lives of people with cancer and other serious diseases. We are very excited about the launch of Epkinly in the U.S., and we look forward to working with AbbVie to continue to expand Epcor development with new studies. We are collaborating with our partner, Seagen, to establish Tivdak as a clear choice for patients with metastatic cervical cancer, and together, we will continue to broaden the tisotumab vedotin in the clinical development program in cervical cancer and beyond. We also continue to look forward to data from the clinical expansion cohorts and progress to the next steps for both DuoBody molecules targeting 4-1BB that are in development with BioNTech.
We anticipate expanding and advancing other early-stage programs, including the potential for additional INDs or CTAs this year. Fundamental to our success is having the right team and culture in place. We intend to continue to scale Genmab based on our planned portfolio development and business needs. Finally, we will continue to leverage our solid financial base to support our growth. We have a lot to look forward to in the second half of the year. That ends our presentation of Genmab's financial results for the first half of 2023. Operator, please open the call for questions.
Operator (participant)
Thank you. If you wish to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Once again, if you wish to ask a question, please press star one and one. We will take our first question. Your first question comes from the line of Vikram Purohit from Morgan Stanley. Please go ahead. Your line is open.
Vikram Purohit (Analyst)
Hi, thank you for taking our questions. We had two on the Epkinly launch. First, we were just wondering if you could provide some color on the types of patients you've been able to treat so far in the first phase of the launch, and any kind of patient characteristics you're observing in the patients you have been able to treat and also in the centers that these patients are coming from? Secondly, on a related note, how are you benchmarking the early phase of the launch internally versus other second line plus DLBCL launches? How are you framing what you're seeing in terms of the launch trajectory here versus other, other recent launches in the space? Thanks. Bye.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Vikram, for the, for the questions. Let's move them over to Anthony Mancini. I think he can give you color on both, both of the questions. Anthony, floor is yours.
Anthony Mancini (EVP and COO)
Thanks, Jan, and thanks, Vikram, for the question. First, we're really, really pleased with the Epkinly launch, uptake to date. I think your question around characterizing a little bit the types of patients that we're seeing here in these early, first phases is very difficult at this point, but because really claims data is pretty limited, but I can give you some sort of sense qualitatively of what we're hearing. It's really in line with our expectations with, you know, about a 27-day head start versus competition. Most of the early patient starts here, or some of the early patient starts are later line refractory patients, and most of them are coming from, centers we've identified as key accounts, mostly academic centers, for the most part.
As the first FDA-approved T-cell engaging bispecific, antibody for the treatment of third line plus DLBCL, really what customers are telling us is they're enthusiastic about the power of Epkinly overall responses, the manageable safety profile, and the seamless and efficient step-up dosing and subcutaneous administration that goes along with it. This, what's encouraging is this is really consistent with what we've been hearing pre-launch from opinion leaders and clinical trial sites, and in our view, reinforces a really differentiated profile for Epkinly.
In terms of, of framing, the launch uptake relative to other launches in the space, I think it's important to ground ourselves in, the size of this first indication. This third line plus relapse refractory DLBCL population, it's a modest one with about 3,600 patients in the US, and it's, it's really an important starting point from which we will build to help make Epkinly a core therapy across B-cell malignancies in collaboration with AbbVie. I think that covers it.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Anthony, and thanks, Vikram, for the question. Let's move on to the next question.
Operator (participant)
Yes, of course. Please stand by. Your next question comes from the line of Peter Verdult from Citi. Please go ahead. Your line is open.
Peter Verdult (Managing Director)
Yeah, thanks. Peter Verdult, Citi. Two questions if I can, or just the first one, if that's the rule. But yeah, firstly, just on GEN3014 HexaBody CD38, we understand J&J is telling investors that an opt-in decision could potentially come in 2023. Now, I realize you're not going to comment on that per se, but could you just remind us how the open label head-to-head trial is progressing in terms of recruitment, event rate, and your level of confidence that hexabody can indeed raise the bar in myeloma versus Darzalex in a clinically meaningful way? Then just quickly on 42 and 46, can you provide an update on what data you expect to have in-house versus presented at a scientific congress in 2023? Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Peter, for the questions. For the HexaBody CD38 program, I can tell you happily that we actually are very actively recruiting the head-to-head arms of the trial with the optimal dose of HexaBody CD38 versus subQ DARA, but we will still need this year for recruitment of the patients. We will actually anticipate that next year in 2024, we will have the readout of that head-to-head study. Of course, we can on an ongoing basis, under confidentiality, share data with J&J, but we still believe that it's very likely that they want to see all the data, or at least a meaningful part of the data of the head-to-head.
It's progressing well, and now in multiple countries, we have initiated new sites and new countries. I think we're doing fine there. Once we have all these patients in, Peter, we will be happy to give you a good update to the market. For 1042, 1046, what we actually want to do is come to a decision point this year, to progress one or both of these programs to the next stage of clinical development. That is the key target for this year, Peter.
We will internally, hopefully get the data to allow us to take a rational decision to move to the next stage, and then it is possible to share that data at a medical conference this year, when we are in time for an abstract, et cetera, maybe a late breaker. For conference, we will also try to present that data publicly. What we could, of course, do is take the decision internally and then potentially flag it up at, like, an event like the Post ASH update event from Genmab after, after ASH, which we usually do to actually educate the market on, on key, key, steps happening with the company.
It's very likely that the full complement of data for either of these programs or both would be presented in 2024 because we may simply not make the abstract deadline this year. We hope that we at least get the data to allow for a rational decision to move to potential next steps together with BioNTech. That's where I probably want to leave it at, Peter, at this point.
Peter Verdult (Managing Director)
Very clear. Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thank you.
Operator (participant)
Thank you. We will take our next question. Your next question comes from the line of Sachin Jain from Bank of America. Please go ahead. Your line is open.
Sachin Jain (VP)
Hi, thanks. My question is actually two follow-ups on the same topics that Peter had. The first one is, do you have any, a best sense, Jan, of how many patients you may have HexaBody CD38 by year end, should J&J want to make a decision? Just to get a sense of how quickly that patient recruitment is going. If you just give us a sense of where you think you might be by the end of this year. Just secondly, to clarify, I think it was clear in the answer, but, are you basically ruling out a conference presentation for 1042, 1046 this year, and your working assumption is to update us at your post ASH, R&D event? Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Sachin, for the, for the questions. For the head-to-head, I mean, I cannot give you a prediction because recruitment is not linear. Usually, once you build momentum, Sachin, you know, this, this goes quicker and quicker. Hopefully by year-end, we will have many of the patients in the head-to-head arms of the, of the, of the trial HexaBody CD38, but probably not all. I think there are still some remaining patients. Whether that will be enough, in follow-up to your and Peter's question for J&J, I don't know. I mean, it's their decision, but I would still stick with 2024 as the more likely, I think, point where we have enough data in order for J&J to take a good decision on potential next steps.
For 1042, 1046, now, it's, it's, it's very likely that the bulk of the data will be described in 2024 at the medical conference. I think for at least one of those, we hope to present also some data this year at a medical conference, because there are key medical conferences in the second term, in the last part of the fourth quarter of this year, which we could potentially use for data dissemination. At this moment, we don't have that data.
I think it's a very good likelihood that we will actually be able to share at least some data at a medical conference session, and then potentially further color on the data at our post ASH events, but it's, it's speculation at this point. We are very rapidly now collecting data. That, that is going well. We are preparing for next steps for a number of programs, but we need the data in order to allow for a rational decision. That's probably where I want to leave at this point.
Sachin Jain (VP)
Can I just take one follow-on? Can you remind me of your target recruitment number of patients for HexaBody CD38 head-to-head?
Jan G. J. Van de Winkel (President and CEO)
Yes. Yes.
Sachin Jain (VP)
Sorry, I was just after what the number of patients you're targeting to recruit in that study is?
Jan G. J. Van de Winkel (President and CEO)
Yeah, we haven't made that public, Sachin, but we are well, well on track, basically for targeting the number we want to, to actually recruit there, but we haven't put it in the public domain, Sachin.
Sachin Jain (VP)
Okay. Thank you.
Jan G. J. Van de Winkel (President and CEO)
All right. Thank you.
Operator (participant)
Thank you. We will take our next question. The question comes from the line of Michael Schmidt from Guggenheim Partners. Please go ahead. Your line is open.
Michael Schmidt (Senior Biotech Analyst and Senior Managing Director)
Hey, good afternoon. Thanks for taking my questions. I just had a follow-up on Epkinly, obviously understanding that the initial indication is of a, a small opportunity in third line plus DLBCL, but could you talk about some of the cadence of possible label expansions? I know the second line phase 3 trial, I believe, is fully enrolled now, and you also started the first line DLBCL trial recently. Just curious of how we should think about the pace of possible label expansions into larger markets. Then, follow up, you know, your competitor, Roche, is marketing sort of this fixed duration treatment aggressively for their CD20 bispecific antibody. Just curious, you know, if that is something that is under consideration for Epkinly as well, or if you're sticking with the continuous treatment in the earlier patient populations. Thanks so much.
Jan G. J. Van de Winkel (President and CEO)
Thank, thanks, Michael. I will hand over both questions to Judith, who is on line here. Judith, you can start with giving your call, and then I can potentially add to that if needed. Judith, please go ahead.
Judith Klimovsky (EVP and Chief Development Officer)
Thank you. Yeah, thank you, Jan. For the label expansion, as you are aware, you know, we announced the positive opinion from CHMP for the third line in LBCL or DLBCL. We also announced that we filed in Japan for similar indications. You know, this potentially gives us more opportunities to reach patients unmet in different territories with the initial indication. Additionally, I mean, we announced the positive data from on follicular lymphoma, third-line plus, and we are engaging with health authorities, as Jan well alluded, which will provide potentially additional expansion to other B-cell malignancies, in this case, FL. Additionally, you know, we have three phase three studies as per clinicaltrials.gov, as per today in follicular lymphoma, in relapse refractory in combination with R2, in first line DLBCL, in combination with R-CHOP, based on the stellar data that we made public at ASCO and EHA.
We have in the third line or above, EPCO versus GemOx-R or VR.All these phase 3 studies will allow us more opportunities to compare to full approval or expand the indications. This is with regard to question 1. With regard to question 2, I would like to make a clarification first, that the treatment until progression is disease and setting dependent. The treatment of the progression was important in the pipeline plus for DLBCL because of the nature of the disease, and I would believe that sustained aggregation of B-cells with the CD20, it could be beneficial for patients. Having said that, you know, we also did MRD in the study that showed that a good proportion of patients, around 50%, get MRD negativity.
We allowed, or we suggest that the right thing to do is, you know, to treat the progression in the belief that these patients will continue to get benefit. You know, if it's a decision from the side or the physician and the treating physician and the patient. In other settings, though, the duration is more limited, and this is related to earlier lines where they are, we treat for 1 year or for 2, 2 years, depending on the disease of the setting. I hope this helps.
Jan G. J. Van de Winkel (President and CEO)
Thanks. Thank you, Judith. Maybe Anthony Mancini can add some further color on the fixed duration question. Anthony Mancini, please go ahead.
Anthony Mancini (EVP and COO)
Yeah, I know. Thanks, Jan, and thanks, Michael, for the question. I think in third line plus DLBCL, as Judith sort of described, you know, the setting matters and difficult to treat patients have already undergone several unsuccessful fixed duration therapies, so maintaining treatment until progression effectively provides, in our view, patients the greatest chance for a positive outcome. With Epkinly, obviously, this is done with even with a treat to progression approach with less chair time per patient through the first six months compared to the competition. As Judith outlined earlier, in other disease settings and earlier lines with less heavily pretreated patients, we're exploring fixed duration regimens for Epkinly.
Jan G. J. Van de Winkel (President and CEO)
Okay, thanks. Very clear, Anthony. Thanks, thanks a lot. Thanks, Michael, for the questions. Let's move to the next question.
Operator (participant)
Thank you. We will take our next question. The next question comes from the line of Asthika Goonewardene
Asthika Goonewardene (Managing Director and Senior Biotech Analyst)
Hi, guys. Thanks for taking my question. Again, congrats on delivering on another solid quarter. Just a quick financial one: Does the increased OpEx guidance for 2023 include an increase in expenditure for GEN1042 or GEN1046? In your first month of sales of epkinly, I know I don't want to tease too much out of the data here, but have you had any patients from the community centers that are being referred to the academic center? Just wondering if you were seeing that in the early data already. Lastly, on the potential data that you hope to present for GEN1042 or GEN1046 later this year, if you do do that, would that be in just one tumor type, or could there be possibility of more than one tumor type there? Thanks.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Asthika, for the questions. At the first one, I will definitely hand over to Anthony Pagano, the second one, to Anthony Mancini, but let me take the third one. I think right now we are collecting data in multiple cohorts, Asthika, so we haven't decided yet which which cohort we have enough data to make a decision to move to the next step. Very likely in the public presentation, it will probably be in 1 or, or maximally 2 settings, I think, for GEN1042 and GEN1046, but that's not decided yet, but that at least gives you some direction. Maybe we can move over to Anthony Pagano for the question on the OpEx guidance.
Anthony Pagano (EVP and CFO)
Sure. Yeah, to be clear, the vast majority of the higher investment is reflective of what I said in my comments, where I did a double click for you in terms of the increased and accelerated investment in for epcoritamab. The comments in the text of our, our company announcement and some report around other pipeline products, there's nothing there for any of the products that's individually significant or material. What I really would like you all to leave with is really that the, the, the increase in acceleration, the vast majority of it is absolutely down to epcoritamab and the key drivers supporting that, that I outlined in my opening remarks.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Anthony. Maybe move over to to Anthony Mancini for the Epkinly question on community center patients versus academic. A bit more color there, potentially.
Anthony Mancini (EVP and COO)
Yeah, really, Astica, at this, at this point in the launch, the vast majority of, of the, of the starts are coming from the, academic centers and, and hospitals at this point. I'll, I'll leave it at that, and, and as, as more data matures, we'll be able to share a little bit more around the, the setting detail.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Anthony. Thanks, Asthika. Let's move to the next question, operator.
Operator (participant)
Yes, of course. Please stand by. Your next question comes from the line of Emily Field from Barclays. Please go ahead. Your line is open.
Emily Field (Director)
Hi. Thanks for taking my questions. I was just checking here 'cause I wasn't sure. For Epkinly, you know, Roche said last week that they've had some feedback from the regulators that the Polox regimen needs to be even given that it's moving towards standard of care, should be a comparator arm for any first-line DLBCL trials. You know, is that your take, and is that included in your first line programs? Just any thoughts on the, on the first line development there? Then also a question, you know, I know that the label language for Epkinly is, should be hospitalized, and that did allow for some flexibility for healthcare professionals to determine the appropriate level of monitoring. Just any color that you could give on, you know, how that's being enacted in the real-world setting, and just what the regulatory process is to getting that hospitalization requirement removed. Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thank you, Emily, for very good questions. I will hand over both to Judith first, and then maybe Anthony Mancini can give, can add to the second one, if needed. Judith, why don't you give it a go?
Judith Klimovsky (EVP and Chief Development Officer)
Yeah. Yeah, thank you, Jan. Thank you, Emily. I will start with the second one with regard to the hospitalization. As you well alluded, the wording reads, "should be hospitalized," not "must be hospitalized." However, you know, the should is that the patient should be monitored, you know, close to the hospital or in close to that setting. With regard to the removal of the hospitalization, as we flagged it up in several calls, there was an evolving and knowledge with epcoritamab or Epkinly in terms of the requirements for patients' monitoring. In the expansion for the first approval, we made the day 15, 24 hours hospitalization mandatory.
In parallel, in new studies, we made it optional, leaving it to the patient and investigator to discuss whether they can be accessible to a hospital, but not in the hospital. We made the hospitalization optional and gave the option to treat it in the outpatient setting as well. Additionally, we have a study ongoing testing only this outpatient setting, so we will have data accrued as we go, with both options, patients in the hospital or patients remaining in close proximity to the hospital. This is with regard to question two. The question one, with, regarding to POLIVY, is what, was that the question?
Emily Field (Director)
Yes, and just whether that needs to be the comparator arm.
Judith Klimovsky (EVP and Chief Development Officer)
Yeah. Yeah, yeah, yeah. Again, thank you for the question. Well, POLIVY is an option in first line, you know, that, or POLIVY you see, with, in conjunction with rituximab and chemotherapy. We have the phase 3 ongoing study is epcoritamab versus R-CHOP, because R-CHOP is the gold standard of care as well. POLIVY is an option as first line, but as you well know, the approval was based on PFS without OS benefit. Some sites might choose R-CHOP for patient, some sites might not. The standard of care, you know, as R-CHOP is, is very strong. In conjunction with that, we have in one of our, we call basket studies, we are exploring very actively the potential combination of epcoritamab with POLIVY rituximab and chemotherapy, and this is ongoing.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Judith. Emily, I think it's clear, I mean, this is an option. This is not mandatory, so it's different from what I think you have heard from other competitors.
Asthika Goonewardene (Managing Director and Senior Biotech Analyst)
Great. Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thank you. Let's move on to the next question.
Operator (participant)
We will take our next question. The question comes from the line of Yaron Werber from Cowen. Please go ahead. Your line is open.
Yaron Werber (Managing Director and Senior Biotechnology Analyst)
Great. I have a, a couple of questions. Maybe the first one, just thinking about, is there any way to get an accelerated approval into first-line DLBCL, or is the only way is to really do a full study? I know you're doing a combination, that you alluded to, plus or minus R-CHOP in first-line. I think that probably doesn't have data in about 4 years or so, but is there any chance to, to get an earlier approval? Then secondly, on 3014, are you able to release data publicly before J&J's opt-in option, or are you just gonna wait for J&J to make an, a decision and only then present the data? 'Cause I, I believe it's your dataset, so do you drive the public disclosure of the data? Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thanks, thanks for the questions. I think the first question I will hand over to Judith to see whether there are options for potential more aggressive, more rapid approval for the first line diffuse large B-cell lymphoma setting. Let me take the second one for for 3014 for HexaBody CD38. It's our data, and yes, we can release data without the agreement of J&J for sure. It's the option of Genmab to do that. Judith, maybe you can handle the first question.
Judith Klimovsky (EVP and Chief Development Officer)
Yeah. The regulations related to accelerated approval, so part H, are very delineated, and first-line DLBCL doesn't fall in this category.
Jan G. J. Van de Winkel (President and CEO)
Thanks. Thank you, so that's clear. Let's move to the next question then.
Operator (participant)
Thank you. Please stand by. Your next question comes from the line of Xian Deng from UBS. Please go ahead. Your line is open.
Xian Deng (Executive Director of Equity Research)
Hey, thank you for taking my questions. Two, please, both on epcoritamab, potentially additional indications. The first one, for follicular lymphoma. In front line, I can see you have a trial, the phase 3 trial in combination with R2, but you also have lots of other trials, trials in follicular lymphoma with either Rituxan or just with Revlimid. Just wondering, how do you actually think about a combination partner in follicular lymphoma in general, especially how does it work in, in terms of, I mean, this is a much more indolent disease? Are you more cautious with combination with other drugs? The second question is on CLL. I'm just wondering if you could remind us where, you know, where are you with, with epcoritamab in CLL, and what is your general strategy here? Are you aiming to potentially target the high-risk patients, like, Richter syndrome first, or are you targeting your all comers? Thank you very much.
Jan G. J. Van de Winkel (President and CEO)
Excellent questions, Xian, I will hand them both over to Judith, who can address them really well. Judith?
Judith Klimovsky (EVP and Chief Development Officer)
Yeah. Thank you. The phase 3 ongoing in relapse refractory follicular lymphoma is combination with R2, based on the approved R2 regimen, for this particular disease. This is based on, I would say, a very, very nice data, of the combination of R2 plus Epco that was presented in the oral setting at ASCO and EHA this year, that showed an unprecedented level of efficacy, and in particular, in those difficult-to-treat patients, as patients with post-24 or double refractory. The phase 3 is comparing R2, which is approved in this, line and setting, in the, and versus R2 Epcor. You know, it's given by the fact that, there is no restrictions for Epcor to be, infused with Rituximab because it's a different epitope, so we are not restricted, by that.
This is the phase 3 ongoing. Additionally, we are testing in a phase 1b/2 Epcoritamab plus lenalidomide, only without Rituximab, to have this data as well, but the phase 3 is in combination with R2, which is the approved regimen. This is with regard to R2. With regard to CLL and Richter, we have a study ongoing. We presented very good data in Richter as well in CLL, in patients heavily pretreated, all of them failing ibrutinib, and most of them BCL-2 as well, most of them with TP53 or mutations. There we found a very interesting and encouraging single-agent activity. In both diseases, the strategy is to combine, to make it even better for the patient and to combine with lenalidomide, ibrutinib or R-CHOP, based on the disease, in both disease. The study is actively ongoing, and we plan to share more data in these two very promising settings in, in a coming congress.
Jan G. J. Van de Winkel (President and CEO)
Thank you, Judith.
Xian Deng (Executive Director of Equity Research)
Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Xian.
Operator (participant)
Thank you. We will take our next question.
Jan G. J. Van de Winkel (President and CEO)
Let's move to the next one. Yep, please go ahead.
Operator (participant)
Please stand by. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead. Your line is open.
Peter Welford (Research Analyst)
Hi, thanks for the question. Just two quick ones. Firstly, a financial one, just trying to understand the split of the P&L, in terms of should we be thinking about on the COGS side of things, that there will be a cost of goods? Because my understanding was that you pay away 50% of the gross profit to AbbVie in the cost of goods side. I got a little bit confused, I guess, as to why that isn't there, and how you, whether you're gonna disclose that in the future. Just on the split of cost, the guidance would seem to suggest relatively modest second half versus first half increase. Are there any sort of one-offs at all in the Q2 R&D that we should think about to explain the phasing?
Secondly, I just wanted to come back to a comment that, that Anthony made in the, in the opening remarks about the cost, where he said that some of the reason was increased and accelerated dose optimization work for Epco to improve the profile. Just curious if you can go into any more detail on that, in terms of what does the increase in accelerated dose optimization work mean? Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Peter. I will ask Anthony Pagano for to address both of these questions and potentially Judith to step in on the second one. Anthony, why don't you get get going?
Anthony Pagano (EVP and CFO)
Yeah, of course. In terms of the, the COGS and, you know, the elements being there, the, the, the cost of the actual product, as well as the, you know, the pay away to, to AbbVie, Peter, you're exactly spot on. Our, our view for Q2 was that it wasn't material. Once you have a chance to read the detailed financials, we disclosed that we put that in SG&A for this quarter. Moving forward, that will most likely be broken out as a, a separate line. Your second question around phasing, I wouldn't say there's nothing or, or anything too specific as it relates to the, the phasing. What you would have seen in Q1, our year-over-year growth rate was 51%.
Now, on a year-to-date basis, that has moderated a little bit, now down to 45%. As you would imagine, as we think about H2 of last year, that's when we really started to put our foot on the gas pedal as it relates to a number of investment opportunities, including further building out the U.S. market in anticipation of the launch for epcoritamab. I think the comps in the second half of the year, in terms of OpEx, will, will be in a, in a, in a different place relative to where they were in H1. As it relates to, you know, specifically, around phasing, there wasn't anything necessarily one-off in the first half of the year. Judith, do you want to address Peter's question on the dose optimization?
Judith Klimovsky (EVP and Chief Development Officer)
Yeah. Yes, sure. Thank you. It's, as Anthony expressed, it is accelerating, means, you know, accelerating enrollment and increasing the number of patients to potentially provide the data to, support Epcor as, best in class in terms of safety and efficacy.
Jan G. J. Van de Winkel (President and CEO)
In follicular lymphoma.
Judith Klimovsky (EVP and Chief Development Officer)
In follicular lymphoma. Correct.
Jan G. J. Van de Winkel (President and CEO)
Yeah. Thanks, Judith. I think, Peter, that's probably where we can leave it at, huh?
Peter Welford (Research Analyst)
Sorry, just to be clear, there's no plan then to, to make any fundamental, sort of, any changes beyond in terms of, you know, the device or in terms of the, the drug itself. This is purely for profile some of the work you've talked about before in terms of outpatients and in terms of follicular lymphoma dose.
Jan G. J. Van de Winkel (President and CEO)
This is the step-up dosing regimen, Peter. This is just basically to get a more optimal regimen for follicular lymphoma.
Peter Welford (Research Analyst)
That's great. Thank you.
Jan G. J. Van de Winkel (President and CEO)
All right. Thanks. Thanks, Peter.
Operator (participant)
Thank you. We will take our next question. The question comes from the line of Matthew Phipps from William Blair. Please go ahead. Your line is open.
Matt Phipps (Group Head of Biotechnology)
Thank you for taking my questions. I, I wanna... I know it can be tough this early in the launch, but what's any of, can you contribute any of the Epcor sales to channel inventory that you might think modulates here in the near term? Then the Epcor DLBCL-1 phase III trial recently changed on clinicaltrials.gov, pushing back the primary completion from 2024 to 2028. Wondering if that is what we should expect or if there's kind of other analysis that could come before that. Thank you.
Jan G. J. Van de Winkel (President and CEO)
Matt, thank, thank you very much for the questions. I missed the first one. I must admit I couldn't hear that. Maybe you can repeat the first one. The second one can definitely be answered by Judith, for sure, but can you repeat the first one, please?
Matt Phipps (Group Head of Biotechnology)
For EPKINLY, was there any kind of excessive channel inventory build initially that can sometimes happen, right when a drug is launched?
Jan G. J. Van de Winkel (President and CEO)
Okay. Okay. All right, thanks, Matt. The first one, maybe you can Anthony Pagano can address that one.
Anthony Pagano (EVP and CFO)
Yeah, sure, happy to. As I, as I highlighted in my opening remarks, look, I mean, we're, we're, we're super pleased with the launch so far. The team is in place. They're executing well. Feedback has been positive, as Anthony Mancini highlighted. Look, I, I think we're talking about really pretty small numbers here, you know, around a month of sales. There, there's nothing in the, the reported number, Matthew, that I, I would kind of be pointing you to really, really focus on at, at this stage. Again, I think it's just small numbers, a month of sales, nothing that I would particularly get you to focus on other than what's already been said on today's call.
Jan G. J. Van de Winkel (President and CEO)
Thanks. Thanks, Anthony. Then maybe, Judith, a bit of color on the timeline change on the Epcor diffused large B-cell lymphoma trial?
Judith Klimovsky (EVP and Chief Development Officer)
Yeah, I think in event-driven studies, and points at event-driven, you can have projections, but, you know, you follow the course of events and project completion date based on course of events. This is the only comment I can make.
Jan G. J. Van de Winkel (President and CEO)
Thank you. All right, Matt, that's probably it for these, two questions, and then let's move to the next one, operator.
Operator (participant)
Yes, please stand by. Your question comes from the line of Rajan Sharma from Goldman Sachs. Please go ahead. Your line is open.
Rajan Sharma (Executive Director)
Hi, thanks for taking my questions. Just two. Firstly, on I&I, and obviously that's an area that you're expanding into, so could you just kind of help us understand where we may get some additional clarity on plans there, and whether we may be able to get some clarity on what the specific asset or the first asset in I&I will be, and whether that will be this year? Secondly, just on the additional investment behind EPCO, can you just help us understand how much of that is actually kind of a pull forward from what you were expecting to do in future years, versus how much is kind of absolutely new?
Jan G. J. Van de Winkel (President and CEO)
Thanks, Rajan, for the questions. Let me give you a bit of color on I&I. It's very early days. We have a number of programs internally which we are progressing pre-clinically, and then they need to be tested on animal models, and then the best ones will be ready potentially for clinical work. That is a few years from clinical introduction, Rajan. We also have, of course, the argenx partnership, where we actually have two concrete targets we're working on, one for I&I, one for cancer. But we are now creating the lead molecule. Also that is a few years of clinical introduction. We will actually update you in the future on the exact phasing.
We are only going for differentiated, truly differentiated antibody-based therapeutic candidates here. The good thing is we have a number of programs already ongoing at Genmab and others starting up now with with argenx. The timing is still very much dependent on how effectively we can move forward through the pre-clinical and animal testing phase. Animal tested, some of the candidates are going to be slotted in pretty quickly, so we are moving rapidly, but it's still a few years from clinical introduction in patients. For EPCO, the investment question may be to Anthony Pagano.
Anthony Pagano (EVP and CFO)
Yeah, as we think about investing in our business, we're always on the lookout for opportunities, particularly for epcoritamab, where we can expand and accelerate. I outlined for you the areas which we've done that for so far this year in my opening remarks. As I think about the, the, the increase here, look, I think this is a little bit on, on, on the margin. We're, we're probably talking about relatively small numbers. I would say that the, the vast majority of this is probably expansion of work and acceleration.
Again, we're always looking for opportunities where it makes sense to from an investment perspective, to expand and accelerate, particularly on epcoritamab, we're gonna do just that. I know, Rajan, I'm not really giving you a precise number, but I would leave you with those remarks and really for you to think about this as more of our investment framework and how we think about investing in our products, and the majority would be around expansion.
Jan G. J. Van de Winkel (President and CEO)
Thanks, Anthony. Thanks, Rajan. Let's move to the next question, operator.
Operator (participant)
Thank you. We will take our final question. Your final question comes from the line of Jonathan Chang from Leerink. Please go ahead. Your line is open.
Faisal Khurshid (Director of Equity Research)
Hi, guys. This is Faisal Khurshid on for Jonathan. just wanted to ask if you could sort of remind us, how are you thinking about the potential positioning of opportunities for GEN-1046 compared to GEN-1042? For example, like, how could these products be potentially complementary to each other versus potentially being, like, more of an either/or type of decision? Thank you.
Jan G. J. Van de Winkel (President and CEO)
That, that is a very detailed question for which we can give a very lengthy answer. What I've said publicly, up to now is that we believe that we can actually position them differently in different settings to different tumors, based on what we see in the clinic right now. That will become clearer, hopefully, in the coming months, when we are going to share data, I hope, or at least speak about the data at our post-ASH events. The short version is, we think that we can actually position them in different tumors and different settings. It will not be an either/or, but they will be very clearly developed, we hope, in different therapeutic sessions.
Faisal Khurshid (Director of Equity Research)
Thank you.
Jan G. J. Van de Winkel (President and CEO)
Thank you.
Operator (participant)
Thank you. I would like to hand back for any closing remarks.
Jan G. J. Van de Winkel (President and CEO)
Thank you for calling in today to discuss Genmab's financial results for the first half of 2023. If you have additional questions, please reach out to our investor relations team, and we hope that you all stay safe and remain healthy, and very much look forward to speaking with you again soon.
Operator (participant)
This concludes today's conference call. Thank you for participating. You may now disconnect.