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Goldman Sachs 45th Annual Global Healthcare Conference

Jun 10, 2024

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Good 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
CFO, Genmab

Yeah, thanks, Rajan. It's great to be back here at this wonderful conference this time in Miami. 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 up front to set a bit of context, and then we really look forward to diving into your questions. 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.

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 the recent and successful launches of both EPKINLY and TIVDAK, and also the recent strong performance that we've seen as we exited 2023 and got 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 eight 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 for 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 1 is really focused on launch excellence and execution for both EPKINLY as well as Tivdak. Then number 2 is really putting our foot on the accelerator for our mid- to late-stage pipeline, particularly EPKINLY GEN1046. Let's not forget about Rina-S. Rina-S was one of the key deal drivers of the recent acquisition for ProfoundBio. 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. 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.

Let's get started.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Let's set quite a high bar. So I hope that can meet that. But yeah, thank you for the intro. So maybe a timely place to start coming off the back of ASCO, Acasunlimab or GEN1046, which I still refer to it. 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
COO, Genmab

Yeah, I know, Rajan, maybe I'll take this. We're really excited about the data. Just to remind you, this was a non-small cell lung cancer population that is PD-L1 positive and non-driver mutated. And the study looked at 3 different arms, 1 monotherapy, 1 Q3 week in combination with pembrolizumab, and 1 Q6 week in combination with pembrolizumab. And what it showed was an 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 a phase III.

Our plans, as was discussed last week, is to move this into a phase III and have the first patient in by the end of the year.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay, perfect. And I guess just on that differentiation point, what is it? We've obviously seen data for ADC, so the TROP2-directed ADCs, for example. How do you think that 1046 kind of differentiates relative to what we've seen previously?

Anthony Mancini
COO, Genmab

Well, when you think about IO 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
Pharma & Biotech Equity Research, Goldman Sachs

And then I guess just on timings, 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
COO, Genmab

Well, again, as we said last week, the regulatory, 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.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay.

Anthony Pagano
CFO, Genmab

Yeah, and I think just there, this is a progression from what we signaled to the market last November on our Q3 earnings call. We said based upon what we saw, we were 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. In terms of additional data from the lung population, should we expect that throughout the course of this year? Obviously we have ASCO, we have World Lung Conference. Could those be potential areas where we get additional data?

Anthony Mancini
COO, Genmab

Yeah, 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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
COO, Genmab

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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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 at least?

Anthony Mancini
COO, Genmab

I think we've learned a lot about 4-1BB biology as we advance both 1042 and 1046. So yeah, I think there's some learnings that'll be applied to the 1042 program.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay, perfect. As you said, there's a lot to talk about. Maybe we move to DARZALEX.

Anthony Pagano
CFO, Genmab

Maybe just quickly on 1042, just to give everyone kind of the path forward there. We said we were committed to providing an update by the end of the year, kind of similar to what we did for GEN1 046 last year. Now, whether that's going to be public data or just an update like we did for GEN 1046, we'll have to wait and see. But we're doing a lot of work and trying to drive some learnings from 1046, see what can be applied for 1042.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. Then, yeah, maybe just moving to DARZALEX. There's obviously kind of consistently been a huge amount of innovation in the multiple myeloma space, new mechanisms, new targets. The midterm outlook for DARZALEX from here against that con?

Anthony Mancini
COO, Genmab

Yeah, 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 are seeing, we're continuing to see, despite a very competitive multiple myeloma, we're continuing to see new patient share outpace total patient share with growth is 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%. And that's grown tremendously year on year, the 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, and line and beyond. And that's what's panning out.

We really see DARZALEX growth both in transplant-ineligible and transplant-eligible frontline patients being the driver of future growth.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

As you talk to kind of the increasing penetration in frontline, I guess firstly, given the data and the experience that 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
COO, Genmab

Look, 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+ 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. And then obviously the second line, there's competitive risk coming, including some of the products that came out of your own portfolio. So thinking about talquetamab and 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
COO, Genmab

I 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 and TALVEY. So we continue to see 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
Pharma & Biotech Equity Research, Goldman Sachs

Perfect. 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 you kind of can't give us too much detail, but just in terms of timelines, are you still kind of tracking in line with what you've provided?

Anthony Pagano
CFO, Genmab

Yeah, I mean, absolutely. I guess to kind of back up a little bit, to remind everybody, the hypothesis here could 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, different concepts, bispecifics, ADCs, etc. 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 subQ versus HexaBody-CD38. So you're right, we've started that trial, that head-to-head. We're on track to have the data in hand by the end of the year. The opt-in decision by J&J. So what we've done is that nothing has changed as it relates to what we said historically. We're on track.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. And that head-to-head trial, what does a positive outcome look like to you guys?

Anthony Pagano
CFO, Genmab

Well, it's going to be looking at the totality of the data, right? We have to look at response rate, complete response rate, the overall safety profile. We put that all together from a target product profile perspective. We're looking at what's going to be ultimately something that's going to create value for patients. We have to look at the totality. 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay, perfect. Maybe if we turn to epcoritamab or EPKINLY, obviously kind of we see the quarterly sales. It looks like the initial launch has been favorable potentially relative to competitors. So could you maybe just talk about what you've seen, how you'd characterize the success of the launch to date?

Anthony Mancini
COO, Genmab

Yeah, no, I think we're really pleased with the launch to date. We've seen very strong uptake in the U.S. and Japan, and now we have approvals around the world. I think really to characterize some of the success, I think it boils down to a couple of things. First, it's the profile of EPKINLY. If you think about a 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.

What that's resulted in is a very rapid access and institutional formulary uptake. That's really been the driver of success. So we're really pleased with the US and Japan performance. Those two countries actually account for about 90% of our sales to date.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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
COO, Genmab

Look, 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 US, it's 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 US. 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
CFO, Genmab

Okay. And 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 eyed a market a couple of years ago that we decided to prioritize for Genmab. And we can see now it's already paying dividends. We had 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay, perfect. And I realize 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 that 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 at kind of third line plus.

Anthony Mancini
COO, Genmab

Yeah, no, that's a, as we think about the patient population upfront, because of the unmet need being so high, what we saw in the initial phases were really a lot of fourth, fifth, sixth line patients. As 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 it's a really reassuring thing. Now we've had a permanent J code in place in the U.S. since January 1st, but claims data is still 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. And then maybe just thinking about 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 the near term, particularly kind of considering that Columvi has phase III data in the second line coming before EPKINLY?

Anthony Mancini
COO, Genmab

So I 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. I think it's being presented, I think, in a week. But it'll 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
CFO, Genmab

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 on 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. That's ultimately where we want to take EPKINLY is to the frontline setting. So certainly fully acknowledge what you said in terms of the Roche phase III data and second-line, acknowledge at the same time we're really focused also on getting EPKINLY into the frontline.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. And just on that frontline piece, since you mentioned it, kind of what's your level of confidence in R-CHOP versus the Pola-R-CHP regimen being kind of the correct backbone?

Anthony Mancini
COO, Genmab

Look, I think that R-CHOP is still widely used and continues to be widely used. And in all the feedback we receive from top opinion leaders around the world, we think we have a regimen and a trial design that's going to be very, very relevant in the frontline setting. And we're actually really excited to see that trial read out.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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
COO, Genmab

Well, certainly it hasn't hurt the uptake so far, right? This is really from a class perspective, something that's pretty consistent in the DLBCL space. What's exciting is we've done optimization work both in DLBCL and FL. 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. We're excited about the growth prospects as a result of that.

Anthony Pagano
CFO, Genmab

Yeah. And then there also is a reminder, a number of the ongoing phase III 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
Pharma & Biotech Equity Research, Goldman Sachs

Perfect. Maybe just moving again through the pipeline or the portfolio, TIVDAK, and I know that's an asset that you guys sometimes feel that the market underappreciates or overlooks. 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
COO, Genmab

Yeah. So on TIVDAK, again, in the US, 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 innovaTV 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 innovaTV 301 data in other countries around the world, including Japan in early 2025.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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
COO, Genmab

Yeah. So the innovaTV 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 is 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 will likely update the program later on this year.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Maybe we can talk about ProfoundBio. The recent acquisition and you talked about Rina-S as being kind of a key driver of that acquisition and why you're excited. As always, not alone in the folate receptor alpha 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 Elahere, which is already on the market?

Anthony Mancini
COO, Genmab

So 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 six products on the market that others have developed and commercialized. Six years ago, we built out development and commercialization capabilities. And we continued to build on top of that early phase of out-licensed products with royalty, milestone revenue 50/50s. This third phase of Genmab is really all about moving to the greater than 50% phase. And with Rina-S as that sort of backbone of that, we think it moves us into that next phase and continues to, 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 expressors, which the first generation folate receptor alpha ADCs have shown activity in, but actually the greater than 1% expressors. And to give you some context, the greater than 75% expressors of folate receptor alpha in PROC represent about a third of the population. Greater than 1% expressors 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 to 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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
COO, Genmab

So I think ProfoundBio had shown some data in PROC and endometrial in the past. I think we're going to, 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
Pharma & Biotech Equity Research, Goldman Sachs

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 Mancini
COO, Genmab

I think it's across indication.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. And then just on that one in terms of data updates. So the last update we saw, well, 36 patient data at the time of the acquisition. What should we expect going forward?

Anthony Mancini
COO, Genmab

We'll likely see an update with more patients later this year.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. Any kind of, if I could push you a little bit more in terms of number of patients, is that 50% more, doubling?

Anthony Mancini
COO, Genmab

No.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

No. Okay. I tried.

Anthony Pagano
CFO, Genmab

You tried. This is not falling into category of interesting questions. 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 this 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. I think the other important point here, in addition to everything that Anthony said, outlining 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.

Now that 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. That's an important point here. This is not a situation where there's an additional investment that was required to de-risk the program prior to starting those registration trials. It's a really important point.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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 ProfoundBio? Will it be kind of fully integrated into Genmab or will it be almost kind of a separate group that operates?

Anthony Pagano
CFO, Genmab

I mean, I 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 on board 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 a classic kind of textbook 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. And then maybe just on the financials of that deal, and you've talked about expecting the ProfoundBio transaction to be diluted until the first year of Rina-S sales, which I think is 2027. Is that primarily R&D costs or is there an SG&A element to that as well?

Anthony Pagano
CFO, Genmab

I think we said the year after launch to get that out there. So there'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's 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 we'll think about this and Anthony will comment on this in a minute. We'll then think about what additional markets we may want to go into. Again, that will be very much product-driven, market-driven, what makes sense for us to do, likely did in Japan. Now, some people could have questioned, well, why is Genmab investing and 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, anything you want to talk about potential geographic expansion and investment?

Anthony Mancini
COO, Genmab

No, look, 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
CFO, Genmab

Just real quick, I mean, I do want to just sort of re-emphasize something I've been saying now for probably a year and a half, which is around our focus on investments. 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 what's called 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. Okay.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Got it. And I guess just on that R&D piece and kind of just thinking about operating expenses ex Profound, and you provide 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, is there an, within current guidance, is there an expectation that there will be a phase III initiated?

Anthony Pagano
CFO, Genmab

When you're formulating guidance for a program or a company that's 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 start a 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, it's not a major driver and not a major, it's more just what's going to be in the ranges that we've previously communicated.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Very clear. Maybe we could just in the last few minutes just touch on BD. So obviously following the ProfoundBio acquisition, you kind of commented on the call that you got balance sheet flexibility. What should we be thinking about from a BD perspective? Because you have 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 going forward?

Anthony Pagano
CFO, Genmab

So first thing first is 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 progressed and again, putting our foot on the gas pedal there, particularly as it relates to starting those registration trials. So that is job number one. We're making that super clear both externally and also internally. Now, as I think about additional inorganic growth or BD or M&A, whatever you want to call it, I think you put it into two boxes. Box number one 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 make sense for us. Now, having said that, part of the ProfoundBio acquisition is also that we've 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 number one, which is what we've done historically. Now, box number two is something that looks a little bit more like what we've done for ProfoundBio. And there I come back to what I said is that we really have to 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, we'd 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. 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
CFO, Genmab

Yeah. I mean, there's a lot to be excited about in Genmab, but I'll kind of leave it where I started. We've got a super strong foundation, some very exciting growth opportunities. We have the in-market performance and 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 in 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
Pharma & Biotech Equity Research, Goldman Sachs

Okay. Perfect. I think we're about right on time. Anthony, Anthony, thank you very much.

Anthony Pagano
CFO, Genmab

Thank you. Always a pleasure. Thank you.

Rajan Sharma
Pharma & Biotech Equity Research, Goldman Sachs

Thank you.

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