Genmab A/S (GMAB) Earnings Call Transcript & Summary
June 10, 2024
Earnings Call Speaker Segments
Rajan Sharma
analystGood morning, everyone. Thanks for joining. My name is Rajan Sharma. I cover European Biotech and Pharma for Goldman Sachs, including Genmab. I'm very happy this morning that we have Anthony Pagano and Anthony Mancini from the company to join us. Thank you, everyone. So Anthony, hand over to you, I know you want to make a few introductory remarks, and then we'll dive into the Q&A.
Anthony Pagano
executiveYes. Thanks, Rajan, and it's great to be back here at this wonderful conference this time in Miami, and it's great, for those in the room, to be here with you as well and those that are listening in virtually. I'm going to spend a couple of minutes upfront to set a bit of context, and then we really look forward to diving into your questions. And Rajan, I'm sure you've got some really interesting questions for us. So I can't wait to get to that. It's really an exciting time for us here at Genmab. We're continuing to accelerate and expand our entire business. We've built a super strong foundation, and that's across our team, our technologies, our pipeline and, of course, our financials. Now on top of that, we've got some really exciting growth opportunities that we really look forward to diving into with you in just a bit. So if we unpack that foundation, first, at the very core, is great science and technology. We've built a super strong pipeline, a really rich pipeline, coupled with a suite of innovative technology platforms. And more recently, we've added to that, with the recent acquisition of ProfoundBio, adding in a bunch of novel ADC type platforms. Second, we're also really excited about these recent and successful launches of both EPKINLY and TIVDAK and also the recent strong performance that we've seen as we exited '23 and gotten into Q1 of this year. And third, as you know, we have a really focused and disciplined approach to investment and capital allocation. Here, we're absolutely focused on driving better outcomes for patients, and at the same time, driving and creating long-term shareholder value. And then fourth, of course, is the strength of our financials. These strong financials really provide us a platform to invest for the future. So let's just unpack those financials very quickly. As you know, we've got a robust balance sheet, coupled with strong and growing recurring revenues. Here, as you know, we have 8 products in market that are driving these very strong and recurring revenues. And you can see this come to life in Q1 of this year, where we saw recurring revenue growth of 42%. So a lot to be excited about today, but as well a lot to be excited about as we look forward to the future. Now in terms of our priorities for 2024, there are a lot of important and key priorities, but for me, there are two that are really at the top of the page: Number one is really focused on launch excellence and execution for both EPKINLY as well as TIVDAK. And then number two is really putting our foot on the accelerator for our mid- to late-stage pipeline, particularly EPKINLY, GEN1046 and let's not forget about Rina-S. Rina-S S was one of the key deal drivers of the recent acquisition for ProfoundBio. So really to sum up, we have all of the ingredients to become that leading innovative biotech powerhouse, a lot to be excited about, super strong foundation, coupled with some very exciting growth opportunities. So with that, Rajan, let's dive into, again, what I'm sure is going to be some awesome questions from you. We're looking forward to it.
Rajan Sharma
analystThat's a quite a high bar, I hope I can meet that. But yes, thanks for the intro. So maybe a timely place to start coming off the back of ASCO. Acasunlimab or GEN1046, which I still refer to as, so apologies on that one. So we have the data. There was some excitement and second-line lung cancer is obviously something that's highly in focus with investors. Could you maybe just give us kind of, from a high level, an overview of the data and what particularly excited you guys?
Anthony Mancini
executiveYes. No, Rajan, maybe I'll take this. We're really excited about the data. As just to remind you, this was a non-small cell lung cancer population that is PD-L1 positive and nondriver mutated, and the study looked at 3 different arms, one monotherapy, one Q3 week in combination with pembrolizumab and one Q6 week in combination with pembrolizumab. And what it showed was impressive 17.5 months of median OS. And actually, the 12-month OS rate was 69%. This compares pretty favorably across other studies, other competitors in the population. The side effect profile was also very manageable, with mostly treatment-related adverse events in the grade 1, 2 range that were manageable. So we're really excited about moving this into Phase III. And our plans as was discussed last week is to move this into Phase III and have the first patient in by the end of the year.
Rajan Sharma
analystOkay. Perfect. And I guess just on the differentiation point, what is it -- and we've obviously seen data for ADC. So the TROP-2 directed ADCs, for example, how do you think that 1046 kind of differentiates relative to what we've seen previously?
Anthony Mancini
executiveWell, when you think about I-O therapy, it's really all about overall survival. So really, we go back to the median OS as a very compelling 17.5 months median OS and definitely worth continuing to explore in a Phase III study. But that's really the key differentiating point in this very tough-to-treat population of PD-1 refractory PD-L1 positive patients.
Rajan Sharma
analystAnd then I guess just on timing there. So guidance has been for Phase III to initiate later this year. In terms of kind of your confidence in that trial that you have kind of all the right elements based on the Phase II data, how would you characterize that?
Anthony Mancini
executiveAgain, as we said last week that the health authority discussions have happened. So we're just excited to move it going forward into the Phase III by the end of the year.
Anthony Pagano
executiveYes. And I think there is a progression from what we signaled to the market last November on our Q3 earnings call. We said base on what we saw, we are very confident that we could take this program to late-stage development. We said we would share data in H1, which we just did now. And then we reconfirmed, as Anthony just said, that we are going to put our foot on the gas pedal for this Phase III trial. The regulatory conversations are behind us.
Rajan Sharma
analystOkay. And then in terms of additional data from the lung population, should we expect that throughout the course of this year. So we obviously have ESMO, we have World Lung Conference. Could those be potential areas where we get additional data?
Anthony Mancini
executiveYes, I think we said we'll have some potential additional color at those meetings to ensure people understand the context of what's been studied.
Rajan Sharma
analystOkay. And then in terms of progress ex lung cancer for 1046, should we expect data for non-lung tumors this year as well?
Anthony Mancini
executiveSo although we've seen some signals in other tumors, our focus is really in the PD-L1 positive non-small cell lung cancer space right now.
Rajan Sharma
analystOkay. And then given that 1042 is also a PD-1 -- sorry, a 4-1BB bispecific. Are there any learnings from 1046 that you can kind of transfer there? And does this increase -- given that you've seen data now, does that increase your confidence in the mechanism of these?
Anthony Mancini
executiveI think we've learned a lot about 4-1BB biology as we advance both 1042 and 1046. So yes, I think there are some learnings that will be applied to the 1042 program.
Rajan Sharma
analystPerfect. And as you said, there's a lot to talk about. So maybe we move to DARZALEX.
Anthony Pagano
executiveMaybe just quickly on 1042, just to give everyone just the kind of the path forward there. We always said we are committed to providing an update by the end of the year, kind of similar to what we did for GEN1046 last year. Now whether that's going to be public data or just an update like we did for GEN1046, we'll have to wait and see. But we're doing a lot of work and try to drive some learnings from 1046 and see what can be applied for 1042.
Rajan Sharma
analystOkay. And then maybe just moving to DARZALEX and there has obviously kind of consistently been a huge amount of innovation in the multiple myeloma space, new mechanisms, new targets. [Technical Difficulty] the midterm outlook for DARZALEX from here [indiscernible]?
Anthony Mancini
executiveYes. Maybe I'll take that as well. We really think there's tremendous growth potential still in DARZALEX, I mean, just to kind of give you an overall picture in terms of the latest DARZALEX situation. I think we're continuing to see -- despite a very competitive [Technical Difficulty] multiple myeloma, we're continuing to see new patient share outpace total patient share with [Technical Difficulty] growth that's continuing. And that growth for DARZALEX is driven by the frontline share. And the latest numbers are such that actually, we're up to 58%. [Technical Difficulty] and that's grown tremendously year-on-year [Technical Difficulty] that continued growth of DARZALEX. And I think strategically, what the intent is here is to make DARZALEX a backbone therapy in combination with others in second, third line and beyond, and that's what's panning out. So we really see DARZALEX growth, both in transplant ineligible and transplant eligible frontline patients being the driver of future growth.
Rajan Sharma
analystAs you talk to kind of the increasing penetration in frontline? I guess, firstly, given the data and the experience the physicians have with it, why is that not higher in terms of what are the factors at the minute that could drive that higher?
Anthony Mancini
executiveLook, I think there's continuing data evolving. There's the PERSEUS data, which was filed and should have an approval later this year. We have the MAIA-OS data in the transplant ineligible population that now has 5 plus years of follow-up. I think 58% share in the frontline new patients, I think, is pretty high. But based on the data that's being generated, we see continued potential for growth.
Rajan Sharma
analystOkay. And then obviously, the second line. There's competitive risk, I mean, including some of the products that came out of your own portfolio, so thinking about teclistamab, how do you characterize kind of the competitive threats in second, third line? And how do you think DARZALEX kind of maintains that backbone position?
Anthony Mancini
executiveI mean, really, if you look at the data generation that's going on in the second-line plus space. DARZALEX is part of many, many regimens in combination, including our own bispecifics, talquetamab, TECVAYLI and TALVEY. We continue to see growth potential across the spectrum. And it's also in combination with the CAR T. So in every line of therapy, we see DARZALEX having a place.
Rajan Sharma
analystPerfect. And then, I guess, one of the developments in your own pipeline in myeloma, HexaBody-CD38, it's something that people have obviously been focused on. I realize that you kind of can't give us too much detail, but just in terms of time lines, are you still kind of tracking in line with what you've provided?
Anthony Pagano
executiveYes, I mean, absolutely. [indiscernible] kind of back up a little bit to remind everybody, the hypothesis here can we apply some of our technologies to come up with a next generation CD38 based product. We tested a number of different concepts. So it wasn't just HexaBody [Technical Difficulty] but different concept bispecifics, ADCs, et cetera. [Technical Difficulty] HexaBody-CD38 stood out. We've done the dose escalation work. We did the expansion work at the recommended Phase II dose. Now we're doing the most important experiment, which is the head-to-head DARZALEX subcu versus HexaBody-CD38. So you're right, we started that trial, the head-to-head [Technical Difficulty] we're on track to have the data in hand by the end of the year [Technical Difficulty] decision by J&J. So [Technical Difficulty] that nothing has changed as it relates to what we said historically in terms of [Technical Difficulty] we're on track.
Rajan Sharma
analystOkay. And in that head-to-head trial, what does a positive outcome look like to you guys?
Anthony Pagano
executiveWell, it's going to be looking at the totality of the data, right. We've to look at the response rate, complete response rate, the overall safety profile and we put that all together. From a target product profile perspective, we're looking that's going to be ultimately something that's going to create value for patients. So [indiscernible], we'll be looking for higher response rates, somewhat similar safety profile. But we have to look at the totality of the data package, very much look forward to seeing that hopefully later this year.
Rajan Sharma
analystOkay. Perfect. Maybe if we turn to epcoritamab or EPKINLY. Obviously, kind of we'll receive the course of sales, it looks like the initial launch has been favorable potentially relative to your competitors. So could you maybe just talk about what you've seen, how you characterize the success of the launch to date?
Anthony Mancini
executiveYes. No, I think we're really pleased with the launch to date. We've seen a very strong uptake in the U.S. and Japan and now we have approvals around the world. I think it really -- to characterize some of the success, I think it boils down to a couple of things. First, it's the profile of the EPKINLY. If you think about the balance between powerful efficacy, manageable safety and a seamless and efficient step up dosing with subcutaneous administration. What we continue to hear from our customers in the U.S. and Japan and around the world is that, that makes a difference and fulfills a really meaningful unmet need in the third line plus DLBCL space. The second piece is, it's really about execution. I think our field-based teams across our account managers, our access team and our MSLs are doing a fantastic job. And what that's resulted in is a very rapid access and institutional formulary uptake and that's really been the driver of success. So we're really pleased with the U.S. and Japan performance. And those 2 countries actually account for about 90% of our sales to date.
Rajan Sharma
analystOkay. And obviously, we see the sales data, but ex the sales data, what else do you look for as kind of the indicators of the launch progress?
Anthony Mancini
executiveLook, I think what I just said is we're looking to -- in different markets, it's different. In Japan, it's really about account opening. That's the sort of driver of uptake. In the U.S., it has been really about focusing on key accounts. And we've seen about 80% of our key accounts ordering. So that's really favorable. And of course, the goal is to continue -- third line plus DLBCL is a modest size of population. There's only about 3,600 patients in the U.S., and it's always been our goal to become the core therapy across B-cell malignancies. So third line plus DLBCL is a starting point. We're very excited about the upcoming PDUFA date for third line plus FL. And again, we see that as another step on our way to becoming a core therapy across B-cell malignancies.
Anthony Pagano
executiveAnd then Rajan there, I think just to kind of draw out a bit what Anthony just said, make sure it's not lost that we were able to also launch in Japan last year that we used the market a couple of years ago that we decided to prioritize for Genmab, and we can see now it already paying dividends with the approval in the United States in May and then the approval in Japan in September. So we're starting to see some dividends from making that investment to open up the Japanese market for Genmab.
Rajan Sharma
analystOkay. All right. And I realized it's relatively early in the launch. And to your point, Anthony, it's a relatively modest patient opportunity. But of those patients that are on therapy right now, is there anything kind of you could call out in terms of background? Is it typically third line, fourth line or later? I know it's quite a broad label that you have in kind of third line plus.
Anthony Mancini
executiveYes. No, that's -- as we think about the patient population upfront because of the unmet need being so high, what we saw in the initial phases were a lot of fourth, fifth, sixth line patients. And with time, we're seeing a lot more purely third-line plus patients. The good thing is we're continuing to hear positive feedback from key customers, and what they're experiencing in the real world is actually what the data has shown. So really a reassuring thing -- now we've had a permanent J-code in place in the U.S. since January 1, but claims data is pretty limited. So we'll be able to add a lot more color on the exact patient profiles as that claims data gets more robust.
Rajan Sharma
analystOkay. And then maybe just thinking about the forward from here in terms of how you think about the continued launch of EPKINLY. What are the key drivers? What are your expectations in near term, particularly kind of considering that Columbia has Phase III data in the second line coming before EPKINLY?
Anthony Mancini
executiveI would say that, again, our goal with EPKINLY is to continue to study different lines of therapy, different combinations and across B-cell malignancies. So certainly, it's too early to comment on any second-line competitor data, and I think it's being presented I think in a week, but it will depend on the risk-benefit ratio. We, of course, have data in combination with GemOx in the second line DLBCL setting that showed very strong complete response rates. And it just really is all about continuing to study epcoritamab across B-cell malignancies, and we feel very confident that the product profile lends itself to treatment, not just in the academic setting, but in the community as well. So we think those are all potential drivers of growth.
Anthony Pagano
executiveOkay. And here in terms of broadening out that clinical development plan, we outlined that in some detail at ASH last year, again, just to put a finer point or highlight the progress we're making in the frontline DLBCL space. So there, we'd like -- in terms of when we started, but as we've signaled before, we're very happy with the progress that trial is making in terms of patient recruitment. And ultimately where we want to take Epcoritamab is to the frontline setting. So certainly fully acknowledge what you said in terms of ROCHE Phase III data and second-line, acknowledged at the same time, we're really focused also on getting up EPKINLY into the frontline.
Rajan Sharma
analystOkay. And just on that frontline piece, since you mentioned it, kind of what's your level of confidence in R-CHOP versus the POLARIX regimen being kind of the correct [indiscernible]?
Anthony Mancini
executiveLook, I think that R-CHOP is still widely used and continues to be widely used. And all the feedback we receive from top opinion leaders around the world, we think we have a regimen that [Technical Difficulty] trial design that's going to be very, very relevant in the frontline setting, and we're actually really excited to see that trial readout.
Rajan Sharma
analystOkay. And on the label currently for EPKINLY, you have kind of the hospitalization post administration. We know that you're working to get that removed. How important is that?
Anthony Mancini
executiveWell, certainly, it hasn't hurt the uptake so far, right? And this is really from a class perspective, something that's pretty consistent in the DLBCL space. What's exciting is that we've done optimization work, both in DLBCL and FL, and we think that as we continue to evolve the profile, we feel more and more confident that large physician group practices are going to continue to broaden their adoption. They've already started to use EPKINLY in large physician group practices, but we think that with optimization, that will continue and we're excited about the growth prospects as a result of that.
Anthony Pagano
executiveAnd then there also, as a reminder, a number of the ongoing Phase IIIs do not have this hospitalization requirement. So certainly, as we move forward and get more experience, something that we're hopeful over time can provide an overall better target product profile.
Rajan Sharma
analystPerfect. Maybe just moving again to the pipeline or the portfolio at TIVDAK. And I know that's an asset that you guys sometimes feel that the market underappreciates or overlooks. So could you just give us an overview of commercial performance of that asset and kind of where you see the potential in the near term?
Anthony Mancini
executiveYes. So on TIVDAK, again, in the U.S., we're seeing 10 straight quarters of demand growth, which we're excited about. The teams are doing a fantastic job with TIVDAK. We're on the heels of a full approval based on innovative 301 data that showed a 30% improvement in overall survival. So we think there's a broadening of the population of prescribers for TIVDAK based on that OS data and the teams are working hard to broaden our prescriber base. And we expect approvals based on the innovative 301 data in other countries around the world, including Japan, in early '25.
Rajan Sharma
analystOkay. And then on the head and neck piece, I know there's kind of an ongoing discussion with the regulator there. Can you just provide us with an update as to kind of where you are?
Anthony Mancini
executiveYes. So the innovative 207 data was presented at ASCO just a couple of weeks ago. It's a study of TIVDAK in the head and neck population. And what we saw in second and third line -- actually, the study enrolled in an intent-to-treat basis, second through fourth line patients in head and neck cancer. So heavily pretreated patients that have very poor outcomes, what we saw is a 32.5% overall response rate, which in head and neck cancer that's heavily pretreated as a very positive overall response rate. If you look at the population of interest, the second and third line head and neck cancer patients, we continue to see a 40% response rate. So we're excited about the data. We have ongoing discussions with health authorities, and we'll likely update the program later on this year.
Rajan Sharma
analystAnd maybe we can talk about ProfoundBio, so the recent acquisition. And you talked about Rina-S as being kind of the key driver of that acquisition and why you were excited. So as always, not alone in the photoreceptor A space. Could you just maybe outline why you're confident in Rina-S in terms of the extent to which the data that you've seen gave you confidence to execute on that acquisition, particularly in the context of [indiscernible], which is already on the market?
Anthony Mancini
executiveSo maybe I'll start with kind of why we're excited about the ProfoundBio acquisition. First, it fits exactly with our strategy. And if you think about Genmab's growth over time, if you don't know the company, we started out really as purely a discovery company. We've continued to build. Now we have 6 products on the market that others have developed and commercialized. Six years ago, we built out development and commercialization capabilities, and we continue to build on top of that early phase of out-licensed products with royalty medicine revenue 50-50. This third phase of Genmab is really all about moving to the greater than 50% phase. And with Rina-S is that sort of backbone of that, we think it moves us into that next phase, and the growth continues from Phase I, Phase II and Phase III. And so I think in addition to Rina-S, we're excited about the complementarity of the ADC platform with novel payloads and novel linker technology, which we think in combination with our antibody platforms, can create incredible permutations of novel products going forward. But to answer your question on Rina-S, the reason we think Rina-S has the potential to be a best-in-class folate receptor alpha ADC is because -- two things. First, we've seen activity in a broader proportion of patients in PROC -- in ovarian cancer, not just the greater than 75% folate receptor alpha expressers, which is the first-generation folate receptor alpha ADCs have shown activity in, but actually the greater than 1% expressers. And to give you some context, the greater than 75% expressers of folate receptor alpha in PROC represent about 1/3 of the population, greater than 1% expressers represent about 90% of the PROC population, so we think it can treat a broader population of PROC patients. And second, the ADC technology that I just talked about looks very different than the first-generation ADCs. So we're not seeing any ocular toxicity. We're not seeing ILD. And the toxicity profile is very different. So we think that it lends itself nicely the combinations. It lends itself nicely to earlier lines of use. And the toxicities that we do see with this hydrophilic linker technology are more hematologic toxicities that are easily managed with GCSF.
Rajan Sharma
analystOkay. And those additional indications with Rina-S beyond ovarian, what are you thinking could be kind of the key areas to focus on?
Anthony Mancini
executiveSo I think Profound had shown some data in PROC and endometrial in the past. I think we're looking to move that forward quickly. And I think the potential for its use across folate receptor alpha expressing tumor types is high, and we'll get there when we get there.
Rajan Sharma
analystAnd then at the time of the acquisition, you talked about potential blockbuster sales for Rina-S. Is that specifically in the lead indication? Or is that across all of the potential indications?
Anthony Pagano
executiveI think it's across indications.
Rajan Sharma
analystOkay. And then just on that one in terms of data update. So the last update we saw patients -- well 36 patient data at the time of the acquisition, what should we expect going forward?
Anthony Mancini
executiveWe'll likely see an update with more patients later this year.
Rajan Sharma
analystOkay. If I could push a little bit more in terms of number of patients, is that 50% more or doubling?
Anthony Mancini
executiveNo. No.
Rajan Sharma
analystOkay. I tried.
Anthony Pagano
executiveIt does not fall into the category of interesting question. It's going to be more. I mean, I think basically, you're going to see more data, right? As we said, obviously, when we made these very important investment decisions, we saw the data that was presented publicly last year, but we were able to look under the hood and see a lot more data. So we'll see what's relevant to present, and we'll share that with the market. And I think the other important point here, in addition to everything that Anthony said that outlined the business case for the acquisition, but for me, as I think about Rina-S being the deal driver for me in terms of allocating this capital to this program, is that based upon everything that we've seen, this is a registration trial ready program. After of the deal is closed, you can rest assured, our team is absolutely in execution mode and putting that foot on that gas pedal to do just that. And it's an important point here. This is not a situation where there's additional investment that was required to derisk the program prior to starting those registration trials. It's a really important point.
Rajan Sharma
analystOkay. Got it. And then just on that piece, in terms of integration, it's your first acquisition as a company, how should we think about Profound? Will it be kind of fully integrated into Genmab? Or would it be almost kind of a separate group that operates?
Anthony Pagano
executiveI can start. I mean I think -- again, the main deal driver is Rina-S. And that will be -- looking at that as being now part of the Genmab portfolio, there are some very talented team members that have come onboard from ProfoundBio that will be integrated into the Genmab overall operating structure. So we'll take the best of both worlds. The existing team members from ProfoundBio that are doing an absolutely awesome job. And now we're going to just augment that with some of the Genmab resources, particularly as it relates to late-stage development. But certainly, they had a ton of momentum if you look at what they've achieved since the founding of the company and how far and how quickly they've brought Rina-S. It's absolutely remarkable. So we're taking the right approach to not mess up or to disrupt any of their positive momentum. At the same time, what can we do to turbocharge it or accelerate it. So it might not be the kind of classic kind of text book kind of thing we're doing. It's really, I'd say, a highly customized approach, particularly as it relates to Rina-S.
Rajan Sharma
analystOkay. And then maybe just on the financials of that deal, and you've talked about expecting the transaction to be dilutive until the first year of Rina-S sale, which I think is in '27. Is that primarily R&D costs? Or is there an SG&A element to that as well?
Anthony Pagano
executiveI think we said the year after launch, just to get that out there. So it's no change to what I said on the call that when we announced the deal. Of course, the primary driver is going to be R&D. Our intent is to start registration trials here quickly. So that will be additive to our overall investment profile. As I also highlighted, again, this is just repeating things we've said in the past. Of course, we have a very high bar for programs we're going to push forward at Genmab, and we'll continue to exercise that high bar in terms of what programs we're going to continue to invest in. And as we think about incremental R&D investment moving forward, it's really going to be driven by these registration type trials. As we think about really sales and marketing -- not really G&A, but sales and marketing costs moving forward, there are a lot of foundational investments that we've made in the United States and Japan that we can leverage. There will be some incremental build out there, I would say. And then certainly -- Anthony will comment on this in a minute, we'll then think about what additional markets we may want to go into, but again, that will be very much product-driven, market-driven, what makes sense for us to do, like we did in Japan. Now some people could have questioned, well, why is Genmab investing in building out a team in Japan? Well, the answer is very clear. Now based upon the market assessment, it was the right thing to do. Anthony will talk about potential geographic expansion?
Anthony Mancini
executiveLook, I think nothing different than what we've said previously that our geographic expansion is going to be on a market-by-market basis. We'll assess the potential for reimbursement, the potential for strategic fit and then we'll do it on a market by market. What I would say, though, is that a product like Rina-S fits very nicely into the portfolio. So as Anthony was saying, we can leverage a lot of the foundational spend we already have. It's a second ADC in the gynecologic oncology space. So those are strategic considerations and operational considerations that we'll make as we expand our footprint.
Anthony Pagano
executiveAnd just real quick, I mean, I do want to just reemphasize something I've been saying now for probably 1.5 years, which is around our focus on investments. And now here, I'm talking about the G&A and getting that number to scale. And that number is at scale. And we're really focused on maintaining that moving forward. Now there are going to be some investments we need to make, to make sure we're managing risk and supporting growth, but that G&A number is a number that we're really focused on managing that the right way. We'll have to make investments in R&D. Ultimately, those R&D investments, particularly the incremental investments, are going to be in the, let's call it, registration trials, which hopefully, if successful, are revenue generating and likewise, making the investments in the sales and marketing and commercialization operations to drive the interaction with customers.
Rajan Sharma
analystOkay. Got it. And I guess just on the R&D piece and kind of just thinking about operating expenses ex Profound, and you provided quite a lot of detail on that. Just as you think about 1042 and there's an update coming at the end of the year, within current guidance, is there an expectation that there will be a Phase III initiated?
Anthony Pagano
executiveWhen you're formulating guidance for a program or a company that is as dynamic as Genmab, with a lot of moving parts, you kind of have to have kind of placeholders for different things. What I would say whether or not we started Phase III for 1042 this year or not is not a major driver in our guidance. I'm not going to get into the specifics of what's exactly in or out, but I would say whether we start the trial this year or not is not a major driver. It's more just what's going to be in the ranges that we've previously communicated.
Rajan Sharma
analystVery clear. And maybe we could, in the last few minutes, just touch on BD. So obviously, following the Profound acquisition, you kind of commented on the call that you've got balance sheet flexibility. What should we be thinking about from a BD perspective? Because you've a history of doing some partnerships with early-stage biotechs, collaborations and then obviously, now you have an acquisition under your belt as well. So what should we think about on the forward?
Anthony Pagano
executiveSo first thing first. As we've just allocated a substantial amount of capital to the ProfoundBio acquisition, particularly Rina-S, we have to be super focused on integrating that and really putting all of the efforts in the Genmab organization behind getting Rina-S really progressing. Again, putting our foot on the gas pedal there, particularly as it relates to starting those registration trials. So that is job #1. We're making that super clear, both externally and also internally. As I think about additional inorganic growth or BD or M&A, whatever you want to call it, I think you put it into 2 boxes. Box #1 is to what we've done historically. This is bringing in tools and components for our discovery engine. And there, I would say nothing has really changed. Our team is still in a very much bottom-up fashion, science-driven fashion, evaluating the landscape. And we'll think about bringing things in that makes sense for us. Now having said that, part of the ProfoundBio acquisition is also that we brought in several novel ADC platforms. We've also given a lot of new tools and components to our discovery team. So we'll still keep on doing box #1, which is what we've done historically. Now Box #2 is something that looks a little bit more like what we've done for ProFoundBio. And there I come to what I said is that we really be focused first on integrating and really putting our foot on the gas pedal for Rina-S. Once that's sort of well under our belts, we can, not out of a position of need, but a position of strength, think about opening up the aperture again and look for opportunities that make sense. And really, from my perspective, would tick all the boxes if we were to pull the trigger, tick all the boxes like ProfoundBio did that is really super obvious in terms of the strategic fit and logic of the deal.
Rajan Sharma
analystOkay. Perfect. And I'm conscious of time. I know you've got a busy schedule. In the last 30 seconds, could you maybe just wrap up on the key catalysts that you guys are focused on for the next 12 months before we meet again here next year?
Anthony Pagano
executiveYes. I mean there's a lot to be excited about in Genmab, but I'll kind of leave you where I started. We've got a super strong foundation, some very exciting growth opportunities. We have the in-market performance and the continued successful launch of EPKINLY and TIVDAK and then really putting our foot on the gas pedal for EPKINLY, GEN1046 and Rina-S. In terms of data, I think, in the second half of the year, in particular, we were very excited about sharing the Rina-S data and really share with the market a little bit more detail why we're so excited about the program. And then of course, on top of that, we have the HexaBody-CD38 progress as well as starting the Phase III for GEN1046. So a lot to be excited about here as we progress through into the back half of 2024 and get into 2025.
Rajan Sharma
analystOkay. Perfect. I think we're about right on time. So Anthony, Anthony, thank you very much.
Anthony Pagano
executiveThank you. Always a pleasure. Thank you.
Anthony Mancini
executiveThank you.
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