Genmab A/S (GMAB) Earnings Call Transcript & Summary

June 8, 2021

Nasdaq Copenhagen DK Health Care Biotechnology conference_presentation 42 min

Earnings Call Speaker Segments

Graig Suvannavejh

analyst
#1

Okay. Thank you, everyone. Good afternoon. Welcome to the 3:50 p.m. session at the 42nd Annual Goldman Sachs Global Healthcare Conference. My name is Graig Suvannavejh. I cover both European and U.S. biopharma names here at the firm. It's my great pleasure to be hosting Genmab today in a fireside chat. And with that, let me welcome CFO, Anthony Pagano; and Chief Development Officer, Judith Klimovsky. So with that, Anthony, it's good to see you. This is your second Goldman Sachs Healthcare conference. And if you may recall, you did this with us last year where you had just announced your broad partnership for epcoritamab and some other earlier-stage assets with AbbVie. So it's great to see you again. And maybe if -- I'm just going to start conversationally just right now, and then I'll have you kind of give an introduction to the company.

Graig Suvannavejh

analyst
#2

But the past year has been a very interesting one. And maybe if you want to recap, from your perspective, as relatively new to the company, like how the year has gone for you and the company.

Anthony Pagano

executive
#3

Yes. Thanks, Graig. It's a pleasure to be here, and I look forward to the conversation today. You're right, it was just a year ago that we announced the partnership with AbbVie. But yes, maybe just to sort of step back and reflect on the last year, from my perspective, we've materially derisked, accelerated and expanded our pipeline, but indeed, our entire business. And this is from looking at our, again, our pipeline, our capabilities, our partnerships, and also our overall financial profile, so I think this has been an absolutely wonderful 2020. And so far, the first 5-plus months of 2021 have also been excellent, well on track on moving our pipeline forward. In particular, we did file tisotumab vedotin, looking forward to a PDUFA date later this year. And epcoritamab, again, when coming back to the AbbVie partnership, which was obviously the centerpiece at ASCO, sitting back here a year later, epcoritamab continues to deliver. That's just an absolutely fantastic product, and I look forward to sort of diving in deeper to talk a bit more about that and the rest of our pipeline and our business as we get into the conversation with you here, Graig.

Graig Suvannavejh

analyst
#4

Okay. Well, great. Thank you for that 1-year review perspective. Maybe just to start off at a very high level, if you could, for perhaps those who are newer to the Genmab story or revisiting for a time now and it might have been a while for them, can you just tell us about Genmab, core areas of expertise, core technologies, what makes Genmab unique as a company?

Anthony Pagano

executive
#5

Yes. Thanks. There's a lot of ground to cover here, so I'll try to really just sort of hit the highlights. At our core, Genmab is an antibiotic company, and we focus all of that antibody science, technology, engineering capabilities in the field of oncology. We've been very focused on building out as our pipeline has matured over the last number of years of building out the appropriate and relevant capabilities to make sure we're in the best position possible to really maximize the value of our pipeline. In that context, we have 2 potential upcoming launches. As I highlighted, we have tisotumab vedotin in later-line cervical cancer and in epcoritamab, potentially a broad set of B-cell malignancies. And this really speaks to the evolution of the company. And maybe to step back, what's the history of the company. Really from its founding, roughly up until around 2013, Graig, we would take products to a certain level of development or technology and really make those available to other big pharma or big biotech companies and really then collect passive income streams. That sort of phase of the company, if you like, has been extremely lucrative and profitable. We now have 4 products on the market, DARZALEX, Kesimpta, TEPEZZA and now amivantamab from that sort of phase of the company. And there's another -- there's a pretty long tail that can generate very significant recurring revenue streams for the years to come. And now as I kind of highlighted, we've taken all of those cash flows to build out our own pipeline. And now we're very excited about a moving pipeline where we own at least 50% of the economics and have 50% control and really pushing those forward to make those potential new therapies available to patients, but really where we're managing and controlling development and ultimately having the larger share of the economics.

Graig Suvannavejh

analyst
#6

And that perspective is very well-appreciated. In terms of that kind of driving that next leg of value creation and getting to a place where you own 50% of the economics and can drive 50% or more of kind of the R&D direction, where do you think Genmab is right now on that journey?

Anthony Pagano

executive
#7

Yes. So I think we've made material -- again, coming back to where I started, we've made material progress here in the last period of time. If I kind of step back and also introduce Judith a bit, I'm sure everyone knows her, but really, as we got into 2017, when she joined the company, our pipeline was just starting to emerge. And where we've now grown from roughly 1 or 2 products in the clinic in 2017 to now 2 assets in late-stage development, with Phase III starting this year, tisotumab vedotin and epcoritamab, and that are very rich and exciting pre-proof-of-concept pipeline. So we expect some of those to mature into later-stage opportunities, so we're very well on the way to building out the development capabilities, to really maximize from a development perspective the value of our pipeline. Then likewise, we've continued to build out the leadership team now, with bringing on board Anthony Mancini as our Chief Operating Officer, to make sure we're really well-situated not only to develop our assets, but really also, in a focused way, commercialize our products moving forward. So I think it's about not only having very, very attractive potential new therapies, but it's having the right team at the leadership level, at the team level, but also the right capabilities to make sure our assets are getting the right level of resources.

Graig Suvannavejh

analyst
#8

Okay. I want to get straight into some of the main investor debates that -- at least in the conversations that I'm having or haven't been having and maybe not so much recently. Clearly, you announced 2021 financial guidance, which I think created a few ripples, and I think it took the market maybe some time to understand where the guidance was relative to what people were expecting. Can you revisit the 2021 guidance? And I think importantly, and I think I've heard you say this before, but I think it's important to remind people the guidance that you gave seems to indicate a base case that's a bit on the conservative side. But I just want to make sure that when we think about 2021 guidance and what you put out there, that we understand better, or maybe to remind me again, kind of the guardrails with which you're providing kind of the lower end and the top end and where pushes and pulls could be as we're now in the beginning of June.

Anthony Pagano

executive
#9

Sure. Maybe it's useful just to remind everyone of our overall financial framework, which has the 2 components, which is the growing recurring revenue streams and then the focused and disciplined investment. As it relates to the growing recurring revenues, at the beginning of 2020, we had one product that was generating recurring revenues. That was DARZALEX. In 2020, we added 2 additional products, namely TEPEZZA and then Kesimpta. And for 2021, we had -- indicated we could add 2 additional products in the form of amivantamab. Now we've actually checked that box, and we can potentially add a fifth, tisotumab vedotin. So I think in terms of the fundamentals of growing our recurring revenue base over time, the fundamentals have gotten much, much stronger. But let's unpack that a bit from a quantitative perspective. Looking at the recurring revenue streams, Graig, I think that it's actually a very, very strong guidance that we outlined for 2021. Think about dara, we projected that will grow around 29% at the net sales level, growing from around 4.1 billion up to 5.2 billion to 5.6 billion. Now in terms of the other 2 sort of inline products, TEPEZZA and Kesimpta on the royalty line, we said that they would grow by nearly 40%. So overall, I think it's a very attractive growth profile. Now on top of that, we'll be adding amivantamab and then potentially tisotumab vedotin moving forward. So I think that's a very attractive revenue perspective. But you're right, there were some kind of puts and takes. Some of that on the dara line was FX-driven, you know where that sort of went. And the other element, Graig, related to the ongoing arbitration with Johnson & Johnson, right, where Johnson & Johnson is claiming that we have to contribute. Obviously, we disagree, but they're claiming that we need to contribute to a royalty they're paying to Halozyme. And that had a roughly DKK 450 million sort of headwind to our revenue, which obviously was something that we don't like, but we thought it was the appropriate thing to do to really just highlight that very clearly to the market what the magnitude of that could be. So all in all, I think very, very strong revenue guidance. And to summarize, we're looking at DKK 6.8 billion to DKK 7.5 billion for the year, dara being a very, very important driver, and it got off to a very strong start in Q1, exceeding $1.3 billion of sales. So at a run rate level, we're already trending towards the middle point of our guidance. So that's a very good place to be. On the OpEx line, that's really a function of a lot of the things I said earlier, where our business has been materially moving forward and materially maturing. So I actually look at this -- the way I look at it is investment opportunities. I think the more investment opportunities, the better. And we'll continue to be focused and disciplined. We're not going in multiple different therapeutic areas, multiple modalities. We're looking at antibodies in oncology in a very focused way. The team is super focused. And we've been very clear about our capital allocation priorities from an R&D perspective, right, around filing and launching of tiso, putting our gas -- our foot on the gas pedal for epco, expanding 1046, that's the DuoBody-PD-L1x4-1BB program. And then more broadly, underpinning all of this is standing up our commercial capability. So I think if I put this all together, Graig, it's a long answer to your question, I really like the overall financial profile of our business.

Graig Suvannavejh

analyst
#10

As it relates to kind of the swing factors in your guidance, and you've identified them as being FX and also the outstanding arbitration that you have with J&J, on the FX side, I mean, FX can swing here and there, back and forth? And for biotech analysts, like myself, I can't certainly -- I don't have any visibility like where that's going to go. But is it possible that FX could swing back into a place where it could be less of an impact? Or is there a reason to believe it actually could be a greater impact? Or has the base case assumption that you've put in place basically tried to solve for both?

Anthony Pagano

executive
#11

Yes. We did try to -- we looked at -- we're obviously -- obviously, I don't have a crystal ball, none of us do, where FX levels are going to go. If we did, we could be in a different line of business perhaps. We try to be reasonable and responsible as we think about putting together guidance, including FX. I believe when we gave guidance, Danish kroner-U.S. was probably around DKK 6.15, let's call it. We gave guidance at DKK 6. I think at the moment, we're probably DKK 6.10 or so. So I think so far, the first 5 months, it hasn't been a major factor. But it was a major factor, looking at 2020 actuals versus 2021. So that's really what the headwind was. I think the other thing to sort of think about is just sort of seeing how Kesimpta will ramp. But also, as we know, we had the pause with TEPEZZA, where there -- some of their supply chain was disrupted. We've heard from them, it has now come back online. But like the rest of the market, they've stopped providing data via IMS, so we're, at this point, looking forward to sort of see how this sort of ramp-up, once the TEPEZZA comes back online, will actually look like.

Graig Suvannavejh

analyst
#12

And then just switching to the arbitration and the number that you put out there in terms of the potential impact. Is that based on the $5.2 billion to $5.6 billion guidance? And obviously, there's some uncertainty around that, which is hard for us to kind of get our hands on because it's an arbitration. I think the company has been a bit, and appropriately so, a little shy about providing some sort of bigger picture answer on kind of what the resolution could be, the timing of the resolution. But I'm going to have to ask you this because I have you here, what's the latest? What can you say if there's anything different? But getting back to the magnitude of the impact of that Halozyme royalty, are there potential kind of swings there as well? Could it be worse? Could it be not as bad?

Anthony Pagano

executive
#13

Yes. So maybe I'll start with the kind of the more specific question around the kind of the guidance, and then we can come back to the arbitration afterwards, but I hate to sort of give you the preview, I don't have much to say on that one, but I'll -- we'll talk about it briefly. So in terms of the guidance and the impact on the ongoing arbitration for 2021 guidance, what I said at beginning of the year is I estimated the impact to be around DKK 450 million. That is sort of looking at the midpoint of our DARZALEX sales guidance, which, as a reminder, is $5.2 billion to $5.6 billion. Now what we need to estimate is what is going to be the total magnitude of SubQ sales. So it's not only estimating the total sales, it's actually more important -- or actually, what's relevant is to estimate the magnitude of the SubQ sales. And what I said there is, I expect at least half of the total sales globally to be SubQ. And we have to see how that plays out throughout the course of 2021. And what we kind of said at the Q1 call was, at least in the United States, we have more visibility. Around 60% of the total sales in the U.S. market are SubQ at this point in time, and it varies in other markets. Coming back to the broader arbitration question, I really can't get into this, Graig. I think it wouldn't be really, as you kind of had said, really responsible. Just to summarize where we're at, we announced in September of last year that we're in arbitration with J&J on 2 matters. One relates to the term of the royalty payment. And the second, as we kind of spent some time discussing, is that Janssen is claiming, again, we disagree, that we need to contribute to the royalty that they're paying to Halozyme. And of course, the timing and potential outcome is inherently uncertain. But I can say, this is something we're -- at the top of our agenda, taking super serious and really spending the appropriate amount of time and energy, defending our very, very important contractual rights, and we'll continue to do so.

Graig Suvannavejh

analyst
#14

Okay. Great. You've got a much larger pipeline now than you had, as you referenced, several years ago. We'll try to get through the different assets. But since we have been talking about DARZALEX, clearly, it's been a magnificent product, both for patients. But obviously, from a sales perspective, $5.2 billion to $5.6 billion is a very impressive number. As we look at the duration of that asset and given what we know about perhaps the competitive landscape, and now you've got a SubQ formulation, you've got use in the first-line, how are you positioning with investors kind of the duration of that asset? And when should we think about perhaps that not continuing to grow beyond, whether it's going to be 8 billion or 10 billion or 12 billion or whatever the number is, but obviously, there are going to be either competitive factors, there's going to be second-generation products, how do you position kind of the duration of the DARZALEX asset because obviously, you're getting a royalty on it?

Anthony Pagano

executive
#15

Yes. I mean what I would think about this, Graig, and I'll focus on, initially, on the growth elements. What we've seen is the sales -- maybe a recap for everybody. We had around, 2019, $3 billion of sales. Last year, it grew to north of $4.1 billion. This year, we're guiding to $5.2 billion to $5.6 million, and we had a very, very strong Q1. I think for the foreseeable future, we expect to continue to see significant growth on the top line for dara. This is a function of the historical investment, the duration of treatment, the really unprecedented data, and Judith can talk about this in a minute, of overall survival in frontline. This is really tremendous, tremendous data. And all that really coupled with the ongoing continued investment. So Janssen is continuing to invest into this asset as we think about investments with dara plus RVd. So I think the growth story for dara has many, many years to go in front of us. What the ultimate peak year sales number is, let's see, let's have that conversation as we move forward. But I don't expect the growth to sort of abate anytime here soon. Overall, I think the fundamentals are absolutely on track. Now in terms of bolstering that growth, we're continuing to look at the next-generation CD38 concept. We think together with J&J, we're the perfect set of companies to look at next-generation CD38 concepts. That's exactly what we did. We looked at potentially a number of different opportunities. Ultimately, we settled on the HexaBody-CD38 product, which we put into the clinic earlier this year. And this is an opportunity for us to really build on all of the great CD38 knowledge that we've accumulated over the years, the biology, understanding where dara has worked, where it hasn't worked, to really invest in this next-generation product. So we're super excited about that leg of the story as well. So all in all, I think I really liked the overall dara franchise, but also the overall CD38 franchise. Your final -- your sort of more pointed question is the duration of the royalty. And I think I just have to park that one, Graig, because that's sort of at the heart of the ongoing arbitration matter with J&J.

Graig Suvannavejh

analyst
#16

Okay. That was my backwards way of trying to get you to comment on that. So...

Anthony Pagano

executive
#17

I'm learning, Graig, how to say "no comment" in about 10 or 15 different languages. So we can test that out later.

Graig Suvannavejh

analyst
#18

I know you referenced the SubQ formulation and that you're seeing that perhaps as of the end of last year. If I have my stats correct, it was almost greater than 50% market share. That's where it will be by the end of the year on a global basis. Maybe it's 60% here in the U.S. now. How should we be thinking about what ultimately that could look like, knowing that perhaps there are some other factors that are at play and patients wanting to stay on an IV. Clearly, I think, on the last earnings call, you had -- the company had mentioned that in some, perhaps, Nordic countries, like the market share was quite high. And is it realistic, I guess, to think that in the U.S., market share could be in the range that is closer to 70% or 80%, just based on what you're seeing with the growth profiles today with FASPRO?

Anthony Pagano

executive
#19

Yes. So maybe I'll talk about some of the numbers and maybe get Judith's perspective on this as well. To maybe put a finer point on the numbers, Graig, in the United States as we exited 2020, we are at around 50%. And at the time of our Q1 earnings call, we had exceeded 60%. So just in that being launched, I guess, it was last May or last June, it went from 0 to above 60% in just under a year. So that's pretty significant uptake. In other parts of the world, it's really a function of reimbursement. You have to look at each individual market. What I would say there, a number of markets, we've seen it like -- almost like a light switch that's turned on, it goes from 0 to a very, very high number very, very quickly. It's probably hard to predict the future, but I think there's a lot of fundamental reasons why both patients and physicians would really gravitate towards the SubQ version. In particular, in the United States, just maybe to ask a question that wasn't -- or answer a question that wasn't asked, there really aren't any practiced economic reasons why people would not receive the SubQ version. But maybe Judith, this is a good time to also bring you into the conversation, what angles you might have on the SubQ version.

Judith Klimovsky

executive
#20

Yes, thank you. So I think that the -- what the SubQ version brings is benefits in terms of convenience, like 5, 10 minutes vis-à-vis longer duration, is safety, is less -- much less incidence of infusion reactions. And last but not least, an aspect that was totally unpredicted before the COVID -- which is COVID, and this is another trigger for whether -- or more appetite for adoption of something that makes you like 5 minutes in the hospital rather than 2 hours. So I think that those 3 factors, and in addition, I mean, no economics not to do it, are playing nicely to take this adoption, I think, that's faster than expected. Because originally, we said no, for new patients, they would go to SubQ. But for existing patients, usually, patients that are comfortable with a certain modality and they go to the infusion clinic, especially when dara, after the first year, which is it requires going once a month and patients become used and they want to go because they'd be like social. So we didn't know how it could play. But certainly, the COVID was an unpredicted situation that accelerated this uptake of the subcutaneous, and we think that will continue as such. And I think that this is influencing as well the slope of the curve.

Graig Suvannavejh

analyst
#21

Maybe one last question on DARZALEX or FASPRO is you've got an approval in amyloidosis, and I think many of us may still be trying to learn about the indication. So maybe briefly, how should we think about that opportunity, numbers of patients, what the standard of care is? And realistically, is this just a -- it's a nice add-on indication, or how meaningful could amyloidosis be? And obviously, for patients, it is meaningful, but from a Genmab perspective?

Judith Klimovsky

executive
#22

Yes. So it's meaningful because it's such a high unmet medical need. I mean there is no drug approved for this disease, FDA-approved, and unfortunately, transplant is very rarely a possibility because patients are old or they have multiple comorbidities because of the disease, like renal failure or cardiac failure. In terms of incidence prevalence, it is assumed that in the U.S., there are approximately 12,000 patients with amyloidosis, in U.S., and big Europe countries, 35,000, 40,000. But in fact, the -- nobody knows for sure because the disease is underdiagnosed, which is very typical in diseases that they don't have active treatment or efficient treatments. So there is -- although the diagnostic test is very simple, physicians don't -- they don't think about it because the point of entry is not hematology, but cardiac failure or renal failure. So part of the -- part of what Janssen is focused on doing is raise awareness about the disease now that there is such an active treatment that improved the cardiac like by twice or the renal by twice or combating hematology. I mean the results are amazing. So they are trying to raise awareness. The other part of the equation is although it was approved recently because of the efficacy of dara across the board, there was some level of usage. So this, we don't know yet how will drive the growth. It's -- again, I mean, for commercial opportunity, we cannot quantify it. As transformative for patients and transformative of what dara is doing is massive because amyloidosis was a graveyard for drugs. I mean lenalidomide failed. They had -- ixazomib failed. I mean all of them failed, and having this data is a great situation.

Graig Suvannavejh

analyst
#23

I want to quickly transition to your bispecific antibody efforts, and I kind of think of it as multiple buckets. You've got your epcoritamab partnership with AbbVie. You've got a very significant partnership with J&J around a number of bispecifics. And you've got perhaps other interests as well, perhaps from a proprietary side. So I realize that we have probably about 15 minutes left in our presentation. But with that in mind, this is clearly an area of emerging interest for investors. There's a lot going on. Maybe let's start with epcoritamab and what's next for epcoritamab. I think the data you've shared have been very compelling. I think you've opened up a first-line DLBCL trial, clearly a lot of excitement. What's the latest with epcoritamab?

Judith Klimovsky

executive
#24

So I can start. But before even epcoritamab, there is -- you asked at the beginning, what positioned Genmab to be different? And one of the things in that position is our technologies because not every bispecific is created equal. And the reason why so many DuoBodies are making a difference for patients is because of the DuoBody. So let's start with epco. So the latest is the data set that we presented at ASCO, which is the 68 patients enrolling in dose escalation with more durability. So basically, what the data strongly indicates is that epco has the potential to be best-in-class in terms of very good efficacy that is sustainable now that we have a median follow-up of 14 months, to the point that 10 out of the 10 patients in complete remission for DLBCL continue on complete remission and 4 or 5 follicular lymphoma. So you have the efficacy, safety that looks very comparable or better in certain domains than other bispecifics in terms of CRS, mostly Grade 1, 2, very limited neurotoxicity, very limited neutropenia vis-à-vis other assets, convenience, subcutaneous and combinability, which is very much linked to safety. And we are assessing the combinability in 5 different parallel cohorts in a study that is in the public domain. So more data to come in terms of combinations, more data to come. We have another study open in CLL that is assessing the potential in CLL. We have the study in Japanese patients to potentially breach with the global studies. We have the Phase III enrolling nicely and more studies to come based on those data sets that I alluded before.

Graig Suvannavejh

analyst
#25

I think epcoritamab is being viewed as perhaps the best-in-class CD3/CD20. And again, the data are still relatively early, but lots of excitement. What's the -- what is AbbVie bringing to the table there? Or is it more than just their dollars? Is it their vision of the development program? Help us understand kind of the scope of where you really think epcoritamab could go in partnership with AbbVie.

Judith Klimovsky

executive
#26

Yes. Thank you. So we elaborated on that when we signed the partnership 1 year ago, but we chose AbbVie because of several reasons, mostly 3. The first one, having the same vision and ambition for the product; when we had limited data, that design as potential best-in-class; having a strong presence in B-cell malignancies. As you know AbbVie has a strong presence in the CLL field, which is something very important to be competitive. And having not just only the dollars, but the right resources to collaboratively invest to -- because we knew that it's not only important to be best-in-class, but do it in an excellent manner in terms of execution and timely execution. So they bring these 3 aspects, and this is why we chose them as a partner for epco.

Graig Suvannavejh

analyst
#27

There are some other earlier-stage assets, but I do want -- in the AbbVie collaboration. Is there maybe a bullet points on 1 or 2 of the assets you want to talk about? Or maybe you want to talk about the broader J&J bispecific collaboration with them as well?

Judith Klimovsky

executive
#28

Yes. I can talk a couple of points with the other 2 assets in collaboration with AbbVie. One is very appropriate, which is the CD37-DuoHexaBody, because we put it in the same basket because of the potential synergy or -- with the CD3/CD20. And the study is actively enrolling in dose escalation. And it depends on data, could be a great addition to the -- to our heme franchise. And the other one is CD3x5T4, which is our first CD3 bispecific in a solid tumor, and we expect to have dose escalation data in the future. Now moving about to the bispecifics or the DuoBodies, let's call them like they are, DuoBodies, developed and commercialized by Janssen, we have RYBREVANT; the amivantamab, which was recently approved, and it was very, very nice to see this beautiful data presented at ASCO. And teclistamab and talquetamab. And for teclistamab, we got BTD, I think, about a month ago or so, and very strong data as a BCMA, CD3. And likewise, talquetamab, the GPRC5 and CD3. So all in all, I mean, they strongly back up what we said from the very beginning, which is the differentiation of our technologies.

Graig Suvannavejh

analyst
#29

And then in light of the arbitration that you have with the company, is it fair to assume that the business end in terms of like the scientific collaboration continues without kind of an eye as to what's happening on that front?

Anthony Pagano

executive
#30

Yes. I mean in summary, you just said it correctly, these things, from my perspective, are decoupled, right? On the one hand, you have the arbitration. On the other hand, it's moving forward and doing the important work for the programs that are under the various partnerships and doing what's right for patients. So these things, from my perspective, are 100% decoupled.

Graig Suvannavejh

analyst
#31

Great. I would be remiss if I left out tisotumab vedotin. This is a program that had been, at least several years ago, highlighted as one of the higher profile assets. It's still an important asset, obviously. And can you walk us through, Anthony, kind of now that you're at the stage that you are, kind of the pre-commercialization, how are you going to resource appropriately that full commercialization effort? And what is the strategy that you have? Obviously, it's partnered with Seattle Genetics.

Anthony Pagano

executive
#32

Yes. So I mean, what we're excited about is this potential, having a novel therapy or new therapy for later-line cervical cancer patients. They're in desperate need of new potential therapies. We think tisotumab vedotin sort of checks that box. We have to go through the regulatory process. But putting that to the side and sort of thinking about us now standing up our commercialization organization, which is part of our 2025 Vision, that's exactly what we're doing. It starts with getting the right leadership in place. We got Anthony Mancini. We now are focused squarely in the United States, together with our partner, CGEN, to make sure that we have -- bring the right resources to bear to get this important potential new therapy to patients at the right time. That's exactly where we're focused. At the same time, Graig, we have an eye towards epcoritamab. As you heard from Judith, we're super excited about this product and are really moving forward as quickly as possible. It's probably premature to talk about specific time lines there. But as we build out our commercialization capabilities, we also have an eye towards the future because we again firmly believe that Genmab has all the right ingredients to be one of the leaders in biotech and oncology and not looking at it as just being tisotumab vedotin. It's kind of then, hopefully, the epcoritamab and then whatever the next product is after that. So we're trying to rightsize this investment and make sure that we're bringing to bear the right resources. So we'll put that all together and ultimately do what's right for patients.

Graig Suvannavejh

analyst
#33

I appreciate that you've got commercialization efforts in oncology as it relates to tisotumab vedotin on the solid tumor side. And then as you think about epcoritamab on the hematology side, at least for me, there's not a direct like, oh, yes, if you know what happens on the solid tumor side, then you're going to be expert on the hematology side. So can you talk about kind of how you kind of make that bridge? Obviously, there's going to be an additional -- hiring of additional sales reps to address that side of things. But where are the synergies? And then where are the areas that you're going to have to build upon that's going to be additive?

Anthony Pagano

executive
#34

Yes. So maybe to sort of -- I think, overall, we're building foundational fundamental commercialization capabilities, right? Now let's pick apart at least these 2 initial opportunities. On the one hand, we have tisotumab vedotin, in partnership with CGEN. So there, again, it's a 50-50 relationship. But CGEN is in the lead, right? So they're going to be the one who is the principal in booking the sales. Now somebody says, so what, you book sales, you just put an entry in the accounting system. It's actually a lot more complex than that. So I think -- when I think about the relationship with CGEN around tisotumab vedotin, it's a way to start to build some of those sort of foundational organization capabilities. We're going to continue to do that with epcoritamab. And there, for epcoritamab with AbbVie, we're actually the principal. We're going to be booking the sales, so what will be a step-up in our overall organizational capabilities. But Graig, you're right, there will be some additional incremental investments that we'll need to make on some of this stuff that I said around booking of sales, but also in terms of the sales force. Ultimately, we'll make sure we bring together the right sales force, MSLs, nurse educators, market access professionals, et cetera, et cetera, to make sure we're appropriately resourcing this opportunity. And I think the benefit too, and this goes back to what we're talking about, why we have these partnerships, is that we can do this together, right? We have the benefit of not necessarily going it alone and learning all of this by ourselves. In the first instance, we do this together with CGEN. And the second instance, we do it together with AbbVie. So I think if we put this all together, it's a pretty logical step-wise approach to building out our commercialization capabilities.

Graig Suvannavejh

analyst
#35

We've got maybe a minute or 2 left with our fireside chat. Maybe I could ask you, going back to maybe the financial positioning of the company. Can you remind us kind of where you are in cash? And with that in mind, as you think about these very nice royalty streams and revenue streams that are coming potentially from the company over the next several years, how do you think about kind of managing that cash? And part of a broader BD strategy, we've seen M&A in this space, granted on a relatively kind of medium-sized scale. Just wondering what is the Genmab BD strategy? And is there -- given your -- the profile of your company, maybe a company acquisition is not really what you're looking to do, but just overall BD strategy right now?

Anthony Pagano

executive
#36

Yes. I think it's a great question. Overall, we're very happy with our overall financial profile, right, both from a balance sheet perspective, but also a cash flow perspective. I think the strong balance sheet has really met -- when we went into the partnership with AbbVie, we can do that from a position of strength and confidence. And I think it's also important as we go through the sort of growth phase of the company to really have this strong balance sheet. It serves us very, very well. I think moving forward, Graig, as we think about capital allocation, our priority is absolutely focused on moving and maximizing our pipeline towards the market. So we have a wonderful set of internal growth opportunities, but we are looking outside the 4 walls of Genmab to complement what we can do. And I would say history is a good proxy, at least -- in the shorter term, history is a good proxy on what to expect. So more recently, over the last sort of 24, 36 months, we've done partnerships with companies like Immatics, CureVac, Tempus and now more recently with Bolt, so very highly complementary to what we do here at Genmab. So I would say more of the same for now. But as our capabilities further are broadened out, we'll continue to evaluate what our priorities are. So all in all, I think the financial position of the company has never been stronger, nor has the company ever been in a stronger position.

Graig Suvannavejh

analyst
#37

Great. Maybe just a quick rundown for investors who are trying to look at the next 6 to 12 months, what do you think are the key events that investors should look for? And while I would probably be better off asking this strategy question for Jan, but as you think about where the company -- where you'd like the company to be in 5 years, what does that company look like in 2026 relative to where we are today? If we were going to be doing this fireside chat in 2026, kind of where do you think our conversations would be like?

Anthony Pagano

executive
#38

Yes. So we're really kind of bookending here short-term and then long-term. So I like it, Graig. So in the short term, we've been very deliberate about what our goals are for 2021. We're looking -- we filed tisotumab vedotin. We look forward to the PDUFA date later there in Q4. We expect some more data in tisotumab vedotin. We expect more data from epcoritamab. We also -- we didn't talk about these programs, which we're super excited about. We're also expecting data from the 2 programs we have in partnership with BioNTech. This is the DuoBody-PD-L1x4-1BB as well as the DuoBody-CD40x4-1BB, so some data there. So rich and data-rich H2 of 2021, so that's what you should be thinking about there. And I think just overall, from a top line perspective, continued material progress with the epcoritamab program. As I think as we move forward, I think our focus -- we set this out in 2013, we set our 2025 Vision. We're very deliberately in a focused way executing against that vision. And again, we've made material progress against that. We have the 2 upcoming launches, so tisotumab vedotin and epcoritamab. So we're really focused now on executing those, getting those to market, expanding the market opportunities for those 2 products. I think broadening that out, we're going to be looking to move more products from early-stage development to later-stage development. So I'm not going to give you a particular number. But as I sort of think about Genmab here in the coming years, it's going to be more of the same, perhaps at a different scale and continue to really deliver meaningful value for cancer patients, but also meaningful and important returns for our shareholders. And I think with our strong foundation rooted in science, we're extremely, extremely well-positioned to do that. And now the final thing would be just to highlight how proud we are of our entire team. And that team is ultimately what makes us successful. It's not just science, but it's the team members who deliver the science and the pipeline for us and for patients and for our shareholders.

Graig Suvannavejh

analyst
#39

Anthony, that was a fantastic way to finish it out. Appreciate your appearance. Judith, it's great to see you as well. Thank you. And I want to thank the audience also for joining our fireside chat. Wishing you all a good rest of the conference and a good rest of the day. So thank you.

Judith Klimovsky

executive
#40

Thanks, Graig.

Anthony Pagano

executive
#41

Thanks, Graig. Our pleasure. Thank you.

Judith Klimovsky

executive
#42

Thank you.

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