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

Good morning and good afternoon. I'm James Gordon, JPMorgan European pharma and biotech analyst. And today, it's my pleasure to introduce this Genmab presentation with CEO, Jan van de Winkel, as part of the JPMorgan Healthcare Conference. So today, we have a 20-minute presentation from Jan and then 20 minutes for questions. And then we'll also have CFO, Anthony Pagano, joining us as well. And you can immediately start registering your questions. [Operator Instructions] And then I'll be reading out those questions in the Q&A segment. So with that said, I'd like to welcome Jan to the conference, and I'm looking forward to the presentation.

Thank you, James. It's a pleasure to join you once again, albeit virtually, at the Annual JPMorgan Healthcare Conference as we kick off 2021. Slides from today's presentation will be available for download on our website immediately after the event. So let's get started. Let's move to the next slide. This presentation may contain forward-looking statements and as such may contain certain risks and uncertainties. Next slide. Genmab is focused on the development of innovative antibody therapeutics with the potential to transform cancer treatment and improve the lives of cancer patients. For over 20 years, we have not wavered from this commitment. In 2010, we linked this core purpose to an extremely effective strategy by focusing on our core competencies of being able to identify the very best disease targets, develop differentiated next-generation antibody technologies and create unique, best-in-class or first-in-class antibodies. In this way, we have been able to turn Genmab's innovative science into medicines, which has effectively allowed us to build a profitable and successful biotech. And I am extremely pleased with our track record of success, but we are only just getting started. Let's move to Slide 4. Genmab has never been in a better position to achieve our vision of transforming cancer treatments, while at the same time, creating value for our shareholders. My objective today is to explain why I say this with such confidence. I want to start by reminding you of the very strong foundation we have built. You can see the key elements here. First, we have a solid track record of success. This success has allowed us to steadily grow and mature all areas of our business. Second, and at the very core of this growth is great technology. We have built several novel next-generation antibody technology platforms and a rich internal pipeline. In fact, we are excited by the prospect of potentially launching 2 of our own product candidates in the coming years. Third, we are leveraging partnerships that can help take our products further than we could do alone. Finally and another cornerstone of our foundation is the strength of our financials. A sound balance sheet and growing recurring revenues affords us to -- affords us a great platform to continue our focused and strategic investments in our pipeline, people and capabilities. Let's look at these elements of our foundation in more detail. Next slide, Slide 5. Genmab has had many successes since our founding in 1999, and these have propelled our growth. So far, there are 38 INDs for antibodies created by Genmab or with Genmab technologies. This has led to 22 Genmab-created products currently in full-blown clinical trials. Of these, 3 have been approved already: DARZALEX with Janssen; Kesimpta with Novartis and TEPEZZA with Horizon Therapeutics, bringing much needed differentiated treatment options to patients. Due to royalties for these approved products and key partnerships with companies like AbbVie, our revenue expanded significantly, and we anticipate 2020 will be our eighth year of profitability. Strong recurring revenue will allow us to continue to invest in next-generation technologies and differentiated antibody therapies. As part of this investment, we have added new commercial capabilities and are further strengthening our world-class R&D teams with key talent, growing our internal competencies to become an end-to-end biotech with a global presence. Led by an experienced and the first senior leadership team, our ability to consistently deliver on our goals, including revenue growth and on our pipeline, along with our potential for future growth, all led to an incredibly successful IPO in 2019, making Genmab a dual-listed company. As I stated before, at the core of our growth is our innovation, so let's look more closely at what makes Genmab special. Next slide. Slide 6. At Genmab, we firmly believe in the natural ability of the immune system to fight against disease. We combine our deep understanding of disease mechanisms, targets and antibody biology with strategic partnerships. Partnerships that can help us take our products further than we could take on our own and partnerships that give us access to high-quality, unique disease targets and cutting-edge technologies. We use our in-house proprietary antibody technologies to create novel products. This is possible because we leverage our own cutting-edge scientific capabilities, innovative scientific approach, translational medicine laboratory expertise and strategic partnerships. By harnessing the power of human antibodies to combat cancer, we create revenue streams we can use to invest back into Genmab and into the continued development of our innovations and our company as a whole. So now let's look at the result of this innovation, our pipeline. Next slide, please. Listed here are all the compounds created by Genmab science or technology that are currently in active clinical development. Those in green at the top are the 7 compounds owned by Genmab, defined as no less than 50% ownership. We anticipate an additional product candidate to be listed here soon as we filed an IND for HexaBody-CD38 in the fourth quarter of 2020. Notably, most of our product candidates are first-in-class, including 2 in Phase III, illustrating the innovative nature of our pipeline. This is absolutely the result of our differentiated proprietary antibody technologies, novel approaches to target discovery and collaboration with partners. Our innovative science and technologies have contributed to 15 products being developed by our partners. Soon, we hope to add 1 of our own products to the list of approved medicines as we are planning our first BLA for tisotumab vedotin in partnership with Seagen. Next slide, please. Our maturing pipeline is the result of our world-class R&D engine. We are confident that our technologies will continue to grow our pipeline because we have already been doing this. In the last -- in the chart on the right, you can see a comparison of our pipeline over the last 5 years. In 2016, we only had 2 product candidates in the clinic. Yet, thanks to our productive R&D engine, we closed 2020 with 7 in the clinic, over 70% of which are based on our DuoBody technology. What's equally important is the continuous growth of our early-stage pipeline due to an influx of INDs as well as new Phase III trials recently announced for epcoritamab and tisotumab vedotin. So now let's take a deeper look at some of the exciting antibodies in our pipeline. Next slide, please, Slide 9. Based on its product profile and upon a successful regulatory review, tisotumab vedotin may be positioned as a first-in-class ADC. Mid last year, we announced very favorable top line results from the Phase II innovaTV 204 study of tisotumab vedotin as treatment for patients who have relapsed or progressed on or after treatment for recurrent or metastatic cervical cancer. This study included a broad patient population, and activity was seen in both adenocarcinoma and squamous cell carcinoma. The prognosis for patients diagnosed in the later stages of cervical cancer is very poor, with 83% mortality within 5 years. So the need for better treatments is very high as recently approved options have relatively low overall response rates and poor overall survival of 6 to 9 months. We are working with Seagen to build the strategy and plans to achieve an impactful launch of -- for tisotumab vedotin, should it be approved, and looking forward to the BLA submission in the first quarter of 2020. In addition, we continue to invest in multiple clinical trials to potentially expand this opportunity. Let's move to the next slide. Epcoritamab, which is part of a broad collaboration with AbbVie, has being studied in the diffuse large B-cell lymphoma and follicular lymphoma, 2 most common types of non-Hodgkin lymphoma, and has the potential to be used in a broad range of B-cell malignancies. We fundamentally believe that the mechanism of effective T-cell redirection against CD20 we see with epcoritamab has the potential to truly disrupt and transform the treatment paradigm for patients with B-cell malignancies across all lines of therapy. Epcoritamab continues to show data that supports its potential for best-in-class, as most recently seen at ASH in December last year. In addition to the excellent data we have seen, epcoritamab is also differentiated by its convenient subcutaneous route of administration, and its off-the-shelf production offers timely treatment and consistency. It's also clear that epcoritamab has the potential to be very competitive beyond diffuse large B-cell lymphoma and other B-cell malignancies with high unmet medical needs, such as follicular lymphoma, CLL and mantle cell lymphoma with potential utility in each in combination and across earlier lines of therapy. We are working with AbbVie on a broad and comprehensive development program so that epcoritamab can realize its full potential, and we look forward to initiating multiple additional studies this year. And we just today, a few moments ago, announced the start of the recruitment in the first Phase III trial in diffuse-type B-cell lymphoma, also triggering a $40 million milestone by AbbVie to us. Next slide. As a reminder, this slide includes some of the results and conclusions from the epco data presented in an oral session at December's ASH meeting. When all aspects of epcoritamab are taken together, it's clear that this bispecific has the potential to be a best-in-class antibody therapeutic that possibly -- positively impacts diffuse large B-cell lymphoma patients by delivering deep, durable responses and improved survival, along with a manageable safety profile. Let's move to the next slide. And this shows 2 of our other promising product candidates and which are DuoBody-PD-L1x4-1BB, also known as GEN1046 and do DuoBody-CD-40x4-1BB known as GEN1042, both being developed in collaboration with BioNTech. Both are first-in-class bispecific antibodies in development for treatment of solid tumors. GEN1046 is designed to block PD-L1 on tumor on immune cells within the tumor microenvironment or draining lymph nodes and simultaneously activate 4-1BB on antigen-experienced T cells as well as NK cells. The Fc portion of GEN1046 is silent. And consequently, the crop arm binding PD-L1 blocks the PD-L1 access while 4-1BB is conditionally activated only when the PD-L1 arm is bound. This focuses 4-1BB activation on the tumor immune synapse and is intended to avoid or reduce some of the systemic toxicities that have been observed with a 4-1BB agonism in the past with other molecules. The first clinical data for GEN1046 was presented at SITC last November, and we are anticipating data from both of these next-generation bispecific programs within 2020 -- sorry, within 2021. GEN1046 and GEN1042 also highlight the power of our DuoBody platform which allows for rapid and efficient screening of several thousands of antibody combinations in order to identify the optimal therapeutic candidate with the appropriate biophysical properties to harness the therapeutic potential via the desired mechanism of action. Let's move to the next slide. We have 3 additional product candidates in Phase I dose escalation soon before following the IND for HexaBody-CD38 at the end of last year. And 2 of these, DuoHexaBody-CD37 on the left and DuoBody-CD3x5T4 in the middle, are part of our broad oncology collaboration with AbbVie, and we look forward to providing you with updates on these in the coming years. I also want to take a moment to update you on our Hexabody DR5/DR5 program here on the right. If you recall, one of our goals for 2020 was to advance the Phase I/II trials in solid tumors, and we have been working towards this. We amended the protocol and additional provisions are made to ensure patient safety. Additional patients were enrolled at a dose level that has so far shown both good tolerability and biological activity. We are currently enrolling more patients to better characterize the preliminary benefit/risk and to optimize the therapeutic index. Based on this data, further work is ongoing to determine next steps in combination with chemotherapy. Let's move to the next slide. As I noted, these are the 3 Genmab-created medicines developed by third parties that are on the market right now, and all of them had firsts in 2020. DARZALEX is a meta blockbuster that has redefined the treatment of multiple myeloma. In 2020, a subcu formulation was approved in both the U.S. and in Europe, making it the first and only subcu CD38 antibody approved for the treatment of multiple myeloma. A second subcu medicine approved in 2020 was Kesimpta for relapsing MS. Considered a potential blockbuster by Novartis, it is the first piece of therapy that can be self-administered by patients at home. And finally, TEPEZZA, which became the first and only FDA-approved medicine for the treatment of thyroid eye disease. We are really enthusiastic about these medicines as they exemplify our commitment to using our world-class antibody expertise to create antibody therapeutics with the potential to fundamentally improve patients' lives. The success of these products also demonstrates the benefit of working collaboratively with strong partners that are complementary with Genmab in terms of technologies, capabilities and knowledge across the whole ecosystem in pharma, biotech and academia. Some of our strategic partnerships provide us with access to unique disease targets and cutting-edge technologies, others like the collaborations with AbbVie, Seagen and BioNTech will help us bring in next-generation antibody technologies to patients in need much faster than we could actually do on our own. And of course, partnerships have also provided us with the financial foundation for our future -- of our current success with recurrent revenues on royalties on DARZALEX, Kesimpta and TEPEZZA that can be used to further invest in our business to deliver our vision. Next slide, please. You can here see the 3 key areas where we are currently investing in. First, in research. We are investing to ensure that we can build on our own strong track records. We have invested in state-of-the-art facilities both in the Netherlands and in the U.S., and we continue to invest in new technologies and formats. Second, for development, we are focus on further scaling up so we can more readily expand from early to late-stage developments. And third, we are also investing significantly in commercialization. We put a strong leadership team in place, and we are now expanding the team to enable us to bring our own products to the market. Underpinning all of this is investment in key enabling functions to both support growth and manage risk. Finally, we see significant potential to drive insights through data sciences. We believe that data science and real-time integration of translational research are key to accelerate development and ensure the right therapies get to the right patients. Next slide, the 2020 guidance. As you can see, both our expected revenue and spend for the past year as shown here on this slide. Once again, 2020 is anticipated to become an eighth year of profitability for Genmab. We expect our revenue to be in the range of DKK 9.25 billion to DKK 9.85 billion. This is still driven by the upfront payment from AbbVie last year and the continued growth of DARZALEX, complemented by the very strong launch of TEPEZZA. We anticipate our 2020 operating expenses to be in the range of DKK 3.85 billion the DKK 3.95 billion. And putting it together, we are planning for substantial operating income in 2020 in the range of DKK 5.3 billion to DKK 5.95 billion. So we look forward to providing you with the actual numbers along with our 2021 financial guidance when we publish our 2020 annual report on February 23. And in addition to our financial guidance, in February, we will also update you on our road map and very firm commitment to corporate social responsibility and environmental, social and governance matters. Let's move to the next slide. Also essential to our success in 2021 are our key priorities for the year. Key among these events is the anticipated submission of our first BLA along with Seagen for tisotumab vedotin. And if approved, tisotumab vedotin would become the first Genmab-owned product on the market, a major milestone for the company. We are also planning, along with partner AbbVie, to accelerate development of our potential best-in-class epcoritamab with the advancement of expansion cohorts and additional Phase III trials. In addition to advancing our late-stage product candidates, we will also focus our resources on continuing to further develop and expand our world-class antibody product pipeline in general. We will also continue the strategic development of our internal capabilities with the goal of building a smart commercialization model as we aim to not only just create medicines to transform cancer, but to provide these medicines to doctors and patients in the most effective manner possible. Finally, we will further strengthen our already extremely solid financial foundation. Let's move to the last slide. As evidenced in the previous slides, we are very close to reaching our inspirational 2025 vision. Our vision has acted as a guiding light for us. It has focused us on our core purpose to fundamentally improve the lives of cancer patients. And this core purpose is linked to a laser-sharp strategy that will allow us to build a profitable and very successful biotech. And today, we actually reached an inflection point in this evolution where we find ourselves with 2 potential product launches in the next couple of years and with more to come as we evolve into a fully integrated biotech innovation powerhouse. Thank you all for your attention. The floor goes back to James Gordon.

Great. Thanks a lot, Jan. Thanks for the presentation. I can see we've also got Anthony with us as well for the Q&A part of the session. So yes, we'll kick off the Q&A. Maybe just to start, you talked about quite a few different bispecific products, with DuoBody within the pipeline. Could we start by talking about the 4-1BB, PD-1 asset? And in particular, what do we see next to that? I know we've seen some early lung data. But what do we see next in lung? And what's the potential part to market? And what about other indications?

Thanks, James, for the question. So for the DuoBody PD-L1 4-1BB, we are now doing 9 expansion cohorts in a total of 9 tumors, different tumors. And we are also doing lung cancer in like different settings. We do them without exposure to prior checkpoint inhibitor and basically, after exposure to a checkpoint and also in other lines of treatment. So what you will see this year, likely in the second half of this year, but we haven't yet decided on timing, James, is the data from the expansion cohorts with the optimal dose of the bispecific in these different settings. And we have seen already some very encouraging data at SITC in not only in lung cancer, but also we saw a triple-negative breast cancer patient and a ovarian cancer patient with some very good responses. We have showed you some initial data from one of the expansion cohorts after checkpoint inhibitor therapy in lung cancer. But we saw actually a number of patients with partial responses and also a number of patients with stable diseases. But this was very early data change. You will get a more mature data set to see this year. Because it's not only important to look at responses, but also at duration of responses, of course, for some of these settings. And that data will become available this year. And the next steps could potentially be further broadening the expansion cohorts we are super excited about, James. And then potentially go to the regulators and actually discuss whether there would be a way to accelerate actually progression towards a product filing, but it's a bit too early to speculate on that right now. But this will be, I think, a very exciting year for PD-1 4-1BB. So thank you for asking that question. And on February 23, we'll actually give you further color on how we're going to step up and maximize the potential of this program because this is clearly still 1 of the 2 key focus areas for the company in addition to epcoritamab. This gets a lot of attention. And I just mentioned like half an hour ago, we flagged up the start of recruitment in the first Phase III together with AbbVie. And I already said in my presentation, there are a number of other Phase IIIs to follow pretty soon. So both of these programs will get a lot of attention, I'm sure, at upcoming meetings and events within 2021.

And when you talk about accelerating, could accelerate, you mean skipping Phase II to do in the Phase I then the Phase III? Or could accelerating could even mean actually filing for an expanded iteration of what you've already got going?

Yes. I mean there's probably a combinations of those, James. I mean what we're doing is we're doing 3 expansion cohorts in the Phase I/II in follicular lymphoma and diffuse large B-cell lymphoma in a month or so, and then we get the right data in those expansion cohorts. We could actually speak with the regulators whether we need more patients and whether we could use each of these arms as a potential way to ask for an accelerated approval. I think it's too early to speculate on that. But what you can also think of is similar to what we did with Janssen for daratumumab, that we actually do basket Phase I studies where we test new combinations for safety and early efficacy in a number of combinations and that we could then actually roll straight from a Phase I into a registrational study upon having the appropriate safety data set and then actually do Phase III start off Phase III to really get into broader and broader labels and more indications. And you will likely see combinations of those, I think, over the coming time. But this will all get a lot clearer within this year. I can assure you there's a lot of focus both at AbbVie and Genmab in progressing and maximizing the potential of epcoritamab. And we have very strong preclinical data, also giving us initial ideas on new combinations. This has not been tested before in the clinic, James. So we believe that this is a potential game changer in the making for B-cell cancers and potentially beyond B-cell cancers in other indications, but we are very excited about what we see currently. And of course, what we need to do is to be a bit careful with projecting progress for all of these programs. Given the pandemic, we are still trying to manage here together in the world. I think we need to get this under control as a population. And then hopefully, in a safe manner, start up new trials and then progress these towards the finish line in order to bring new treatment options to patients because that is in the end goal for Genmab. That's the focus of everything we do at the company, is to bring better medicines to patients, and in our case, cancer patients.

And for epco, so the CD3, CD20, you mentioned combos. What could this potentially be a good combination with? What looks most promising there? Would the combos would be more for refractory patients? Or could that be for frontline patients as well?

Probably both. I think we have a number of combinations, which we know are preclinically very, very synergistic, and it could be combinations of the antibody plus chemo. And this is very traditional in B-cell cancers, but it could also be combinations of antibodies with small molecule inhibitors, which I think is a more modern, next approach way of treating cancers. And also, we believe that it is very good potential actually to combine different antibody therapeutic approaches. And that's one of the reasons, James, that are also added to the basket of programs we are working on together with AbbVie. For example, the DuoHexaBody-CD37 program because CD37 and CD20 are co-expressed on some of these B-cell malignancies. And I think it's also very likely that we go into clinical trials, and potentially further, James, with combinations of antibodies. And we're actually exploring it very broadly together with our partner, AbbVie. I think it's very difficult to predict what will be the golden combination. I mean you see when you look at daratumumab, I mean, this landscape is continuously progressing. I think when we look at the latest developments, I mean, we all know that VRD data had sensational data in frontline. I think it's probably going to be one of the winning regimens. But now Janssen, our partner Janssen, is already combining dara plus teclistamab, which is a next-generation CD3-engaging bispecific, also made with the Genmab technology. They have already arms and trials with dara plus teclistamab plus pomalidomide, the latest generation image basically. So I think it is continuously evolving. And I think that is the way you need to look at drug development. I mean I very much reminded many times by Rituxan. I mean Rituxan is being used in so many combinations in B-cell cancers. And originally, rituximab was just there with a simple chemo, basically in the very first in '97 when it came to the market. So just to remind us all, I think this will be an evolving landscape. And it's very good, I think, for industry, very good for patients, that new combinations are going to be explored, and we are going to be at the forefront of that, James, with epcoritamab because we believe that this molecule has everything we wish to see and a potential winner for patients in the end.

One more epco question, which would be definitely the CD3, CD20 looks like a promising class. But you're not the only company that's got one. There's quite a few other ones out there. And one of the areas where you initially look to be differentiated was that you were the first to go subcu. But that's been copied as well so like Roche had most on their CD3, CD20 are also going subcu. So where else do you see differentiation? in terms of who comes to market first with the subcu? What are your thoughts there?

I mean subcu is a clear differentiation, but you can wonder how long this lasts. We also are differentiated preclinically by being far more potent. Actually this antibody is more potent than most other CD3, CD20 molecules preclinically. It's also more effectively silenced, James. And the level of inertness of the tail of the antibody there is actually believed to be linked to potential side effects by these molecules. And up to now, with the limited data we have seen, and you've seen the last data at ASH 2020, our molecule seems to be safer than several of the competing molecules. So safety may be a distinct differentiator versus other bispecific CD3 engagers. But I think it's probably going to be the combination of the efficacy with a very good safety and tolerability. And on top of that, you got the subcutaneous application route for the bispecific. But it's clear that the competition is also moving quite rapidly. We have to be on our toes, I think, to really stay and become more competitive, I think, in this very dynamic field. But I think, in the end, I think it's going to be good for the patients, I think, and that makes me happy. I think, at the end, they're going to have more treatment options, and we are fully convinced, as I said in my presentation, that epco has the potential to be a best-in-class here, but we still need to show that in bigger cohorts of patients. But the nice thing is 2021 will be the year that you will see the robustness of the plan to unfold. And in time, we'll get more and more data on the Phase I/II study, potentially at the second half of the year, also of the expansion cohort study when we can progress them as readily as we hope to do. But the caveat is, of course, the coronavirus situation. We need to be a bit careful there, James. But I think, all in all, this molecule looks as good as it can get basically from the preclinical perspective. And then it comes down to good execution, James, and that's what we -- that's why we did the partnership with AbbVie. I think they are wonderful. A very, very good drug developers in this B-cell area, and we hope to actually use a lot of their muscle and their talents and capabilities to together build a fantastic franchise and most of all a fantastic new treatment for patients with B-cell cancers and potentially beyond B-cell cancers.

We've talked a bit about DuoBody. We haven't actually talked about what's the biggest driver of [ MPV ], i.e., DARZALEX. So on DARZALEX, you've got the subcu launch going on. So what are we looking like in terms of conversion? And is it actually driving an acceleration in DARZALEX growth? Or is this just to gate a conversion over to subcu? Is it actually an uplift you think? And also is some of the boost because of COVID and the convenience? Could that roll back or slow? What do you think about that?

Yes. The subcu formulation is clearly doing a lot -- it's getting a lot of traction right now. I can tell you that the latest IMS data, which we can follow on a weekly basis, and there are 2 weeks lagging behind. I can tell you that in the states, about 50% of the patients already is using the subcu formulation. Overall, DARZALEX is really penetrating the different lines of treatment very, very readily. 25% of all the patients, and these are November brand impact numbers, James, will get in all of the lines of treatment will get a DARZALEX treatment. But of the new patient starts over all the lines, it's 30%. So this will move up basically from here. Frontline, it's 13% of the patients in the U.S., but new patients start 19% that has never been higher. Then second line, 45% of the second-line patients, get DARZALEX in the U.S., but 60% of the new patient starts. So there's a robust trend upwards. And more and more of that will be subcu. I can tell you that we have heard from our partner, Janssen, without naming the exact country, that in some European countries, the usage of subcu is now over 80% of the usage of daratumumab. So much, much quicker converting into subcu uses than we had anticipated, and that may or may not be linked to the pandemic. And we know that in the U.S., a number of major hospitals have trained nurses, James, to actually move to the patients' houses and inject them in the belly with a subcu formulation in order to protect these poor patients from being potentially exposed to coronavirus-positive other individuals. And we know that, for example, in the Netherlands, I read just before Christmas, on one of the local hospitals in the Netherlands, not even an academic hospital. They have trained teams of nurses to do exactly the same, to go to patients' homes and then treat them with the subcu formulation. Is this new patients or conversion? I think it's a combination. And I hope that Janssen, on the 26th of January, will give you some further color because they don't want me to speak about these trends, but they have obviously a lot of market information. I use it definitely after the J&J colleagues about the same question. I think they will be able to give you probably a bit more granularity here. But I think it's a combination of conversion from IV to subcu, James, and also new patients being immediately moving to subcu. But what we see is the market is clearly growing, and we cannot wait until we see the full year data for 2020 from J&J on January 26. But I can tell you that we are quite confident that we will end up in our target range between $3.9 billion and $4.2 billion in total sales for DARZALEX over 2020. And that is almost like a miracle because at the beginning of the year, when we set the guidance, James, we were absolutely not taking into consideration, of course, this type of impact from the pandemic. Because who could foresee that in January and early February last year?

You're not the only CD38, so there is a bit of competition now. Or is that so -- it's completely not SARCLISA. Is that slowing things? Or is there a bit of a risk that, that slows things down?

I mean what I can follow from the IMS data is that SARCLISA is not doing very well. I mean it's a very small product, and it's not really moving up strongly. So I think they have really -- I think they have challenges, I think, to really penetrate the market. That's just a strong product and such a good company. Let's give Janssen some credit also in the hematological area. But I think the strongest potential competitor for DARZALEX is probably going to move into the clinic in the coming weeks, and that is HexaBody-CD38. I mean that is a molecule that Genmab scientists created, which is unusually potent, like ten to hundredfold more potent depending on which assay you look at preclinically than DARZALEX and actually can hit tumor cells at lower levels of CD38 much harder than DARZALEX can. We are very excited about the potential of that molecule. We are testing -- we're going to test it out initially in multiple myeloma and in diffuse B-cell lymphoma. We'll start with multiple myeloma, James, to do dose escalation to see whether this molecule can be safely applied and dosed into patients. And then in the second part of the multiple myeloma trial, once we know the molecule is safe, we're going to run it head to head against subcu dara and we will only progress that molecule then it is like substantially better than daratumumab. So we have actually -- at Genmab, we have actually looked at different formats, bispecific formats, ADC formats and the supercharged formats. And we cannot find a more potent molecule than HexaBody-CD38. So we are very encouraged by the preclinical data, and we hope that, that will become a very strong competitor. And you know that we have given Janssen an option in 2019 to that molecule. They can wait on the clinical data and depends -- and they have to decide on how much clinical data they want to see before they can take over that development and put a big military machine behind it. And then we could either further build the market from where the market is currently with daratumumab, James, or they could actually move into other markets like basically acute myeloid leukemia, AML, or diffuse large B-cell lymphoma or potentially even solid cancers because this is a molecule with the characteristics that potentially, at least on a theoretical basis, could be far more effective in blocking the ecto-enzymatic activity of CD38, which is underlying some of the immune suppression by CD38, at least that is the model. So I think this could be a molecule to move into solid cancers again. But that's all speculation. Let's first wait on the data. And hopefully, by the second half of this year, James, you get some feeling for safety and how well this can be dosed to patients, basically.

Great. And I can see we're out of time. I'll just squeeze in one more question. So I will just ask, which is, say, your DR5/DR5 development status, where are we on that asset? And do you see this as one that gets accelerated in 2021?

So DR5/DR5, what I said in the update in my presentation is we have found a dose where the safe to use that the molecule because you had some liver tox with that molecule last year, we had the partial clinical hold last year, but that is now over. We are now progressing with the trial. We have also made some different tweaks and changes in the protocol to really protect the safety of the patients. And we actually have seen that at the dose where we can actually safely dose this DR5/DR5 molecule, which is a combination of 2 antibodies, James, we have also seen some very good signs of biological activity. So we are encouraged by that data. We are now trying to work further on optimizing the therapeutic index as we speak, and we're going to prepare for a combination therapy with chemotherapy to do some combinations and then see how strong these combination data will be. And I think that in the -- probably either at the end of this year or beginning of next year, we'll give you updates on that data set, but we'll clearly move forward with that program. And as you remember from the enapotamab vedotin program which we closed down in November last year, Genmab is going to be rigorous in its decision taking. It's going to be data-driven. But DR5/DR5, I think, is a very appealing concept, where we actually have struggled a bit with the safety of the compound, but with very good preclinical data. I mean this molecule is far more potent than any of the 8 previously tested DR5 antibodies ever tested in the clinic. I think it's clearly differentiated molecule. And I think we have now found a dose where we can actually progress that quite robustly in patients. So we will update the market on this molecule. This is 1 of the 7 proprietary programs, James. We will add 1 or 2 more to the proprietary portfolio this year. And then we are excited to progress. And let's see how this will further develop over the coming months.

Looks like an exciting year. Unfortunately, we're out of time and there's a lot by the pipeline we can talk about. So thanks a lot for joining us, and enjoy the rest of the conference.

Thank you, James. And thank you for having us, and stay safe.

You, too. See you, everybody. Bye.

Bye.