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

Let's go ahead and get started. My name is Vikram Purohit. I'm one of the biotech analysts with the Morgan Stanley Research team, joined by my colleague from the EU Biopharma team, James Quigley. This is the fireside chat with Genmab. Before we get started, I need to read a brief disclosure statement. For all important disclosures, please see www.morganstanley.com/research disclosures. And for any questions, please see your Morgan Stanley sales representative. With that, happy to have with me on the stage the team from Genmab. Thanks for joining us. Appreciate it. James, I'll turn it over to you to kick off with some questions, and then we'll just go back and forth. And if there's questions from the audience, please let us know.

Excellent. I mean the biggest thing -- the biggest event happened to Genmab in the last sort of year or so was the approval of product EPKINLY. So that's probably the best place to start. So it's very early. But in terms of the launch, in terms of physician reaction, payer reaction, what's the latest now? And what are your expectations going forward?

I propose if Anthony will like to approach this question, Anthony?

Yes. Great. Thanks, James. You're right. I mean you think about EPKINLY, I think, it's useful to start and put it in perspective about how far we've come as a company and how fast we've come as a company, thinking about it, where EPKINLY was first put into patients in July of 2018. Fast forward to May of 2023 with an approval. Just to put that in perspective, less than 5 years, first patient, first dose to approval. So that speaks to not only the quality of the drug, all of the features of the drug, but also as a company when we really focus on something and that's backed up by a drug like EPKINLY how fast we can actually move. Now if we do fast forward to the launch, we're very pleased as we highlighted on our Q2 earnings call about the initial launch. The team is very much in place, was ready to execute. And so far, they've done an excellent job in executing. Everything we said on the Q2 call continues to be true today in terms of our overall -- how we think about being pleased with the launch, feedback from the customer base continues to be positive. And as we talked about, that initial set of patients that were dosed with EPKINLY in terms of commercial products, we're probably skewing towards at least some of them being a little bit sicker. So with that bolus to work through. I think we're starting to see it working through that. And as we sit here now in September, again, we're very pleased with how the launch is progressing, how the product is performing in the marketplace, but also thinking about it from a Genmab's perspective, we're very pleased with how our team is doing and competing in the marketplace.

Got it. And this is a competitive area as well. So there are 2 to 3 approved on the market, and Regeneron also filed in Europe. But from a competition standpoint, particularly versus [indiscernible], what are your expectations? Or what are the key points of differentiation between the 2 assets that can allow you to potentially win? And what are you expecting in terms of the market dynamics?

So I can take that one, James. I think epcoritamab is having a very, very good efficacy profile also relative to some other competitors at a very clean, a manageable safety profile, very predictable safety profile with cytokine release syndrome. If it happens, it happens always at the first full dose at day #15. So very predictable and that is very much different from what we understand from the other, some of the other competitors. Also very much less stringent hospitalization requirements than the other -- some of the other competitors. And it actually is getting subcutaneously, which is a huge advantage for both patients and doctors. So we believe that actually, the efficacy and safety profiles are shaping up more and more. There will be more data this year also at medical conferences also showing that this is actually very easy to combine a great market all the other medicines and multiple other medicines and the data actually gets better and better. You see very, very good levels of complete responses and very durable responses, it's definitely in the combination. So we believe it's a very competitively positioned medicine. As Anthony already highlighted, we developed it in record time, in less than 5 years from first injection into a patient to an approval I think is really quite stunning where you look at some -- what time it takes for other medicines to move to the market. So we believe that we're in a very solid position to compete effectively. And as Anthony said already before, the customers are very, very positive about the medicine. I think it's a bit too early, James, to really talk about sales and sales relative to one of the competitors, which is also on the market now in the U.S. But I think at the end of this year, we should be able to really give you some pretty good color into what Q4 looks like and we keep receiving positive feedback. So well positioned, I think, for further growth. And what I should highlight, I think, here as we also expect an approval in Europe quite quickly because already in July, we had a positive recommendation from the CHMP. We also expect an approval in Japan because also there from the regulatory body, we have already gotten a positive opinion. And so the Japanese market, we hope to enter also early next year, if not at the end of this year. It's a very, very good market. And the initial market is at least as big as the U.S. market, which I think, not so many people realize that, I think, at this moment, and it's also a different dynamics in that market we understand because once you build up a very good relationship with the customers there, they tend to actually stick with the first mover and not be very open to other competitors moving into the market later. So Genmab has been doing the right thing here to position itself also as one of the really fast-moving and hopefully, in the future, leading commercial companies in this area. So we're very pleased with what we see up till now, but it's still early days.

Now in terms of development, so on the development side, in early lines, first line of DLBCL, the POLARIX regimen was approved. So what are you hearing in terms of feedback from physicians in terms of using that as a regimen. You mentioned before about potentially moving down the combination with POLARIX. Is there anything about EPKINLY that might impact its combinability?

No. I think EPKINLY is very easy to combine with other medicines, and we are doing a frontline study now combining epcoritamab with R-CHOP which is still the standard of care and the gold standard basically for frontline diffuse [indiscernible]. They also have a Phase II study now where we combine POLIVY with Rituxan chemo and epcoritamab because we are looking at different combination therapies. And we also have a number of others to follow, also with novel combinations, James, which haven't been tested at other T cell engaging CD20 targeted antibody. So we are very, very confident that epcoritamab is just a perfect profile to be easily combinable with other types of medicines. And I don't kind of tell you what the golden combination will be. But we know that the landscape is changing and changing quite quickly. The whole field is doing -- is definitely moving towards an era where we see less and less use of chemotherapy, which I think is a good thing for patients in the future because of the -- I think disease is hopefully getting better treatable and manageable in the future, and we want to be at the forefront there. And I think epcoritamab is one of the key assets here for us. And then we have other T cell engagements following very soon thereafter because we actually have a pipeline where we actually have in the preclinical phase, the number of T cell engagers, where we just recently announced the IND filing for 3017, which is also CD3xCD30 T cell engager with fantastic preclinical data, which we hope to move into the clinic this year. So Genmab will continue to fill its clinical pipeline so that we can continuously take from that pipeline, the best molecules and then rank all of them, prioritize them in order of efficacy and tolerability so that we actually can come with better and better therapies for different types of cancer.

2 more questions on EPKINLY and the landscape there. So first of all, just because it's the right combination, so you have your development partner, AbbVie. Part of the development plan was to look at novel combinations with -- from their pipeline and annual pipeline. What's the latest there in terms of potential for moving into new indications, new...

I mean we are doing a CLL and Richter’'s Syndrome trial, a Phase I/II where we actually combine epcoritamab now with Venclexta as well as epcoritamab alone and we already have some very early, highly encouraging data, potentially more to come at ASH Hematology Conference in December, James. But we're also testing other combinations, which we have not yet flagged up to the market to keep the cards quite close to us just because of the competitive situation, but definitely the Venclexta combination is doing very well.

Got it. And finally on this point. We've seen some approvals in second line for CAR-T in DLBCL. To what extent is that going to be a risk for earlier lines for EPKINLY?

We see CAR-T development is not very competitive to the bispecifics because they are off the shelf. They're very easy to give. We all know that CAR-T is quite laborious. It's patient specific. It's very costly to society. And when you look at the total costs and actually quite risky for the patients as well. So we think it's good that CAR-T technologies are being developed as an extra option for patients that the combinability, the easiness of which one can give bispecific antibodies of the shelf many times administered in a way like we do subcutaneously, I think we'll give them a competitive advantage, I think, versus CAR-T. But the landscape is dynamic, James, it will develop and evolve over time. But we believe that actually bispecifics and definitely bispecific T-cell engagers are a very good proposition for patients to repeat them effectively in rapid time and at a very high level of continuance.

Excellent. Vikram?

Yes. Thanks, James. So I thought maybe we could pivot the discussion a little bit towards the HexaBody-CD38 asset. There's been a lot of focus on that program, the potential for J&J opt-in, so maybe we can unpack a couple of different things there. I guess step one, remind us how is HexaBody-CD38 distinct from DARZALEX? And what could it add beyond what DARZALEX has shown us in the real-world setting?

Thanks. I will be pleased to do that. HexaBody-CD38 is a different antibody, this is modified to the HexaBody mutation, that one amino-acid mutation in order to make it more effective and complement killing and actually preclinically with saline sort of the primary tumor cells from patients, it's much more effective than DARZALEX in complement-mediated killing. And another effect is that it can actually kill target cells at much lower levels of CD38 than DARZALEX can do. And the second differentiating aspect from HexaBody-CD38 is that it actually is much more effectively blocking the ectoenzymatic activity of CD38. CD38 is a ectoenzyme involved in the generation of adenosine. Adenosine is an immunosuppressive molecule. And then you can block the formation of adenosine, you potentially have a therapy which can much better relieve immunosuppression. So it can actually activate the immune system, the more effective, that is difficult to prove in the preclinical setting, because we hope to see that in the clinical setting. Because one of the mechanisms of action of DARZALEX is we believe that it activates the immune system against the cancer because how else can you actually explain that we have some patients only treated with monotherapy of DARZALEX living for many, many, many years and with very good quality of life. When it's not -- that is not activating the immune system. And I think when this is a much stronger activity that HexaBody-CD38, you could expect not only higher effectiveness, the deeper responses against different cancers, but also much more durable responses. And I think it's too early right now to conclude that on the basis of the data we have up to now. But there is a considerable level of enthusiasm, I can tell you about HexaBody-CD38 today. I think at your conference about -- I think 60% of the questions is all about HexaBody-CD38. So it's definitely very popular question among your followers and investors and candidate investors.

And I guess on that point then, so it seems like from your perspective, the preclinical rationale is quite clear for why this could be differentiated. How much head-to-head data do you think you would need to see both in terms of number of patients and amount of follow-ups to get conviction that from a response rate and from a durability perspective, this is truly something that's in the real world going to be unique versus DARZALEX.

Yes. We have actually designed a plan together with Johnson, interaction with Johnson that a pretty sizable number of patients, I think, some of it's now at the size now, we cannot really breastfeed information in very, very small amounts to the market and to our potential partners. But this is a sizable number of patients, and I think it depends on how clearly the differentiation is already early on of the 2 arms because this is a relapsed refractory multiple myeloma patients. They need to be naive to CD38 therapy. And the populations are actually very different from what you would see a few years ago because a lot of these patients today definitely have seen a produce and -- for sure. And also in this trial, but here, the nice thing is this is had to have with a sizable number of patients in both of the arms. And then the question is, well, how many patients do you need to see? But maybe you see a split up already very early on in the arms. I think it's too early to judge that. I think next year, then we will see probably different data cuts, we had to have arms and then it's up to J&J, I think when do you want to make up the decision. I think the question now to actually use a next-generation CD38 for treatment of multiple myeloma in the future, is actually getting stronger and stronger than -- now that I hear the message from J&J after the Q2 that actually they think that actually 3 out of 4 patients in the future will be on a Johnson regimen with multiple myeloma. This market is going to be an over $20 billion market. And when you then realize that actually 3 of the 4 top multiple myeloma drugs are coming from Genmab or from Genmab Technology. I think -- and all of these -- with all of these new drugs, a combination with the CD38 antibody seen as the backbone therapy, I think that the upcoming impact from the legislation from IRA, et cetera, Johnson says in somewhere in 2034. I think it's probably going to be very wise for J&J to try to shrink their CD38 antibody for a much better differentiated CD38 antibody as quickly as you can and then try to do test in combinations with all of the new agents because that is the way to make it the gold standard for the future for very, very long time. So I think actually, the requirement for very, very large differentiation is actually getting less and less as long as it's clearly differentiated, I think it would make sound rationale to me to actually try to fix the current CD38 for a new CD38 with higher potency, but we'll have to see.

Got it. Got it. And then on that point, remind us of 2 things. what -- like what is the scope of the agreement with J&J? What are the mechanics of their opt-in process? And the second question admittedly a bit more difficult probably for you to answer is what do you think is a likely process for them to follow?

So I will pass over this tough question to Anthony and then see whether I can add to that. Anthony?

Sure. I mean, the mechanics are actually pretty straightforward. So right now, Genmab is doing all of the Phase I/II work that we've defined the dose escalation, the dose expansion, the head-to-head work. So we're doing all of that work for our risk and account, if you like. We then have a very clear data package that we have to generate as Jan outlined. We then finished that data package. We provide that data package to Janssen. They have a defined amount of time to review it. And if you ended that pack -- that review period, they can say yes or no. If they say, yes, it's an essentially a licensed product to them. They would pay us an upfront of $150 million, $125 million of future potential milestone payments and then a royalty that starts at 20% and then in the early 2030s, resets and goes from 13% to 20%. So think about that as they say yes, they would then take over development and it's a licensed product with the back end economics that I explained. If they say, no, there are rights that revert back to Genmab. Essentially within multiple myeloma, we could potentially develop it for areas where that is not approved or not in late-stage development. But to be practical about it, the development opportunities in multiple myeloma, if the -- not opt in or rather limited. But beyond that, we are free and clear to develop it as we see fit. So that's around the mechanics. Your question could be, when would they kind of make that decision? Certainly, there was a back-end date as I've outlined in terms of very clearly the amount of data that we need to generate and what that whole process looks like. They could, of course, make a decision based upon the overall ongoing review of the data to make a decision earlier on that. But that would be more up to Janssen to make that decision if they wanted to opt in earlier.

Got it. Got it. Okay. if they were not to opt in, do you think it's more likely that you prosecute this independently? Or would you seek an additional partner?

I can take that question Vikram. We are very enthusiastic about targeting CD38. This is the area which we pioneer. And we believe that actually this could be a very effective molecule for us to really develop ourselves. Potentially either in solid tumors because of the potential impact on activation of the immune system because of the inhibitory capacity of the HexaBody-CD38 molecule, or potentially in autoimmune diseases or inflammatory diseases because we already know that targeting CD38 model work we did in the year around 2006, 2007 time frame that where we observed already with daratumumab that you could stop information completely in -- models at least as effectively as TNF-alpha blockers IL-17 blockers at that time. Despite that Janssen has never developed daratumumab and autoimmune diseases, but I think HexaBody-CD38 is potentially a superior molecule also where you could actually even more effectively treat inflammatory diseases, and that is now also falling right in the second focus area. In addition to cancer, we recently announced last year in August, but we would have immune diseases and inflammation as the second focus area. We already know that 2 of the 8 approved medicines are outside of cancer. So we know that actually all medicines can actually work really, really well in those areas. And this is a disease area where actually antibody therapies are known to make a huge impact basically on treatment of patients. And I think whether it's a real need for a novel medicine based on next-generation antibody technologies. And this would actually check all the boxes. So we would likely hold on to this molecule.

Got it. And then one final question from me on this topic. Assuming J&J does opt in and you decided to work on this program going forward together, what do you think the development path could look like in terms of the amount of data you'd need to enable endometrial filing. Have you had these discussions with J&J? And is there something you could -- any color you could provide us on that topic?

No, we have only had the initial discussions with J&J and it's up to them because they -- the nice thing is if it comes -- pay for everything and they give us -- pay us 70% royalty. So much better than we get for daratumumab. This is already not too bad, I think, for Genmab at this point. But what I think J&J could do, and that's speculative, thinking about the FDA [ Johnson ] program, which is being actively discussed now more and more, if they could potentially position HexaBody-CD38 in front line combined with the best standard of care regimen and then negotiate with the regulators to get a -- endpoint and molecular endpoint, basically for initial conditional approval and then actually start on the front line rather than at the back, this is also in the context of IRA, I think a very, very smart move. But this has not been discussed in depth with J&J I think it's still a terminology and planning, which is still developing at the regulatory level. But I think this is probably a perfect molecule because of the fact that with daratumumab and other CD38 targeting antibody, Janssen is right now already treated around 400,000 patients and outside of the 37,000 patients on clinical trials, with the data in different regimens. So there's lots of data on targeting CD38, and this is just another CD38 hitting the target more effectively. I think this will be perfect for like potentially frontline development very early on. So then you wouldn't have to run it against the standard of care, but you can actually study a new standard of care, but that's a speculation. We should probably stop it at this point, but J&J will probably when they hear this probably start thinking about it again as well.

Understood. Okay. Helpful. Thank you, James.

Got it. So your first asset that was approved or your proprietary asset was TIVDAK, which has a new owner. In terms of the launch in a refractory cervical cancer and the data you recently have the confirmatory data, could you talk us through what the reaction has been to that, how the launch is progressing? And then where are the additional development focuses for TIVDAK?

Absolutely. I will probably start with that, but then maybe Anthony can add more on the launch. So I will be very short on that. I think the launch is very encouraging. And we are very, very pleased with what we see until now and we'll speak about it more and more. But that is indeed a second, third-line cervical cancer setting than basically 2 weeks ago, we got the readout from the Phase III confirmatory study, and we have a very, very clear and significant survival advantage in the same setting versus chemo. And also the secondary endpoints, we've only mentioned 2, I think TNF and overall response rate is also very clearly different between the TIVDAK are and the control arm. So that, I think, will allow us to actually get a permanent approval in the United States, but also to file based on this trial in Europe, in Japan and other territories because we were waiting for this data in cervical cancer. Then beyond cervical cancer, this year at AACR, we had some fairly good head-and-neck cancer data. So we believe that we have now more and more data that we can actually roll out TIVDAK into other cancers, and we believe that the potential is far larger than second, third-line cervical cancer. And I know that because I've spoken with the CEO from Pfizer, they are very, very enthusiastic about TIVDAK, they see it as a sync factor, basically in the deal that potential deal Seagen, but this can be developed into a much, much bigger, much more impactful medicine, that is more or less a renaissance going on for antibody-drug. This is a very active one, and there is a lot more tumors, which also express tissue factor. The target for daratumumab, so we believe that actually, together with potentially a new partner, Pfizer, who has actually already expressed to me that they are willing to invest in the medicine if the merger goes through, we can actually much more broadly position TIVDAK. So this will become one of the 2 pillars next to EPKINLY to actually build the next phase of Genmab and then we will add 2 or 3 more than also if we actually hope to hold on to ourselves to actually keep this growth part, which we see as very steep until the early and mid-2030s for the company. So very exciting times, James, the best is yet to come for the company. Then maybe Anthony, a bit more on the launch for TIVDAK?

I mean, so far, we continue to be pleased with the launch. It's performed well. I mean the kind of perspective I would give you around that launch, which came in September of 2021. We had an eye towards building out our U.S. footprint, our U.S. commercialization footprint, not just for cervical cancer with TIVDAK late line, we already had our eye towards the EPKINLY launch, which came about 18 months later. So I think in that regard, the TIVDAK launch was sort of the perfect stepping stone, if you like, to really -- us in a thoughtful way to build out the U.S. leadership team -- start to build out the U.S. field force. And then when it came time for EPKINLY, we had that foundation to really build on top of. So that's the additional perspective I would add around TIVDAK continues to go in the right direction and while we continue to see sequential quarter-over-quarter growth.

Excellent. Coming up on time, we got 2 minutes left, which I'm very conscious of. But 1042, 1046 you expect to release some data for that or release some -- potentially have some data at the end of this year. What can we expect in terms of number of patients, potentially the tumor types and then what are next steps? And then beyond that because running out of time, where should investor be focused for the next sort of 12 to 18 months in terms of the Genmab story?

So for both the biotech partner -- we targeted bispecific antibodies, which you're now referring to, we hope to actually have the data ready to go this year to make a decision, a rational decision on next step of development, and hopefully, that will be end-stage clinical development for both of these molecules. We actually hope to flag that decision up to the market at our post-R&D update, which we hold after -- yearly, we hope to give you some view into the direction this is taking for one or both of these molecules. And then potentially, James, we could actually also present data from at least one of these molecules at one of the 3 candidate conferences this year if we have them in time for the abstract submission, et cetera, or for the late breaker submission, we're super excited about those molecules. You can hear that from my tone here. And if the data cannot be presented this year, James, we will give you any other color at the ASH update, in December. And then we will actually present the data at a medical conference, which we believe is the right thing to do next year and then basically present them in great detail. And for next year, hopefully, more trials and potentially Phase III trials for multiple compounds to be kicked into gear by Genmab during the year and more data on epcoritamab, more data on earlier stage clinical programs like the T cell engager targeting B7H4. We are near the end of the dose escalation here. We're going to bring more molecules into the clinic, and that means that we are going to be more rigorous in rank ordering, prioritizing the different molecules because in addition to EPKINLY and TIVDAK getting broader and broader, we think that we can add 2 or 3 more molecules, we can do multiple parallel Phase III development by the company in the coming time. And the rest of the molecules, James, either need to be don't prioritize at silence or potentially hand it over to partners. There is an option for Genmab to co-own 50-50 once there is a clinical proof of concept is shown. So it's only going to get more and more exciting. This is only the beginning. So I think watch us in the coming years.

Excellent. Jan and Anthony, thank you for joining us. And have you enjoy the rest of the conference.

Thank you.

Thank you.