Regeneron Pharmaceuticals, Inc. (REGN) Earnings Call Transcript & Summary

All right. Good morning, and once again, welcome to the 39th Annual, and first and hopefully only time, Virtual JPMorgan Healthcare Conference. My name is Cory Kasimov, I'm the senior large-cap biotech analyst, and it's my pleasure to introduce our next company to present, which is Regeneron. Representing Regeneron for the presentation are the company's co-founders: CEO Len Schleifer and CSO George Yancopoulos. Please note that following this presentation, we will have a Q&A session right here in the same Zoom room. So there's no need to fight the crowd to get to the [ Burge ] room. [Operator Instructions] So with that, Len, let me turn things over to you.

Great. Thanks, Cory, and it's really good to be here. Normally, it's these first 15 seconds when I look out at the audience and I get worried that no one's paying attention or the room is half empty or everybody is looking at some news that some other company announced, that I get kind of that nauseated feeling in my stomach. I'm just assuming everybody is rapt with attention in front of their computers, and most important, is staying safe and feeling well. So we're going to jump right in. And we'll start with our ever-growing forward-looking statements slide, which you can see. And I remind you that the remarks I make today and that George makes and the rest of the management team will include forward-looking statements, and every forward-looking statement is subject to risks and uncertainties, and you should read this carefully. And you can find more about our risks in our SEC filings. In addition, please note that we're going to be mentioning some non-GAAP and GAAP measures that will be discussed, and the reconciliation of that is at the end of the slide deck, which can be accessed on our website. Okay. So turning to Slide 4. If you will, I'm going to ask you all to follow along. I'll give you the slide numbers. This is our 33rd year, probably 30 of which, or so, we've been coming to this conference. And we have built, over these 3 decades, what we feel is a very strong and diversified growth company. As I'm going to outline further over the next few minutes, the strength of our core products, a wave of new launches and a broad pipeline, position us well for continued and, frankly, for accelerating growth. If you can move on to Slide 5. I'd like to note briefly at this point that we have been performing well on all fronts despite COVID and with respect to COVID. It's been a difficult year, obviously, but for the 9 months ended September 30, we were able to deliver 29% top line growth, 28% bottom line growth. And this is really no small feat given the challenges that everybody endured this year. We also continue to push forward our R&D pipeline, which George is going to tell you a lot about in a few minutes. And so I'm going to move kind of quickly so we have enough time to hear from George the important advances that the company is making. We believe that, in addition to the strong financial performance that I'm going to tell you about, that it's this wave of next product pipeline advances that's allowing us to really say with some degree of confidence that we think the best is still in front of Regeneron. The important thing also to remember is that we'd like to think that the company is based around our technologies and our research and our platforms. And I think if you listen carefully, you'll see just how we leveraged all of that, how George and the team leveraged all of that to, we hope, make an important contribution for COVID-19. Moving on to Slide 6. Let me just briefly give you our strategy. For those -- most of you are probably familiar with the company, but if you're not, we have our in-market products, EYLEA and Dupixent. We're continuing, remarkably enough, a decade in, we're still having significant market growth with EYLEA; and just really getting going with our partner, Sanofi, on Dupixent, where we believe we are transforming the treatment of type 2 inflammatory diseases. But these in-line products, which still have, we think, room to grow, particularly Dupixent, we think that we can really be best-in-class in the immuno-oncology space, and George is going to tell you a lot about that. Beyond these 3 core areas that are going to drive our diversified growth, we have opportunities, such as in COVID-19, our cocktail, which we'll talk more about in a minute. So turning to a little bit more specific. We're announcing this morning, for the first time, our fourth quarter numbers for EYLEA. We had net sales of $1.34 billion. That represents 10% year-over-year growth through a fiscal year of $4.95 billion. These are the U.S. net product numbers, we don't have the sales yet from Bayer. So in the U.S., it's about a $5 billion product in 2020. But we still have a ways to go to realize our potential in diabetic eye disease, and we're initiating some direct-to-consumer to drive disease awareness in the diabetic eye space because we think that really represents an opportunity for growth, both in a variety of diabetic eye diseases, such as diabetic macular edema as well as diabetic retinopathy. Hopefully, to prevent the complications of diabetic eye disease, we want people to be more aware of the treatments that are out there. We do focus on the science, and we are exploring other ways to leverage our EYLEA franchise, including high-dose formulations for less frequent dosing, and we have a robust preclinical gene therapy and a few other novel approaches that we're studying in the laboratories. Turning to Dupixent. We have what we feel has been a really terrific launch. Working closely together with Sanofi, we were able to show nearly 70% worldwide sales growth in the third quarter versus a year ago. And that was growth across all of our approved indications. And we are advancing clinical development. People talk about disease, a pipeline of diseases in a drug. We truly are executing on that as you'll see in a minute and you'll hear more from George. These are the third quarter numbers. We don't have the fourth quarter numbers just yet. And people know that, in our collaboration with Sanofi, we have turned the corner on profitability last year and continue to see substantial growth in our share of the collaboration profits, which, as Dupixent continues to grow, obviously, we hope to get substantial leverage and grow these numbers even more significantly. Where are we? People are somewhat worried. Competition is coming. Or have you reached a plateau? The numbers and data would suggest otherwise. The number of people in atopic dermatitis, 2.3 million. Nearly 1 million in asthma. Another almost 100,000 in chronic rhinosinusitis with nasal polyps. You add all of these up. These are just the current approved indications and we really have only just a little bit over 5% market penetration. So there is room for substantial growth. There's room for growth that could depend on other indications, but tremendous room for growth in, actually, even the approved indications. So this -- we know that competition will be coming here and there, but this drug presents a really substantial barrier given its robust safety. I think that safety is very important when you're dealing particularly with the adolescent or the pediatric populations. Our drug has really been shown to be able to deal with type 2 inflammatory diseases such as atopic dermatitis or asthma, but do so in a very specific and thereby very safe manner. Much more going on which George will talk to you about in a minute. Our way to get leadership in oncology starts with our version of an anti-PD-1, which is Libtayo. As you know, it's the first approved anti-PD-1 in cutaneous squamous cell carcinoma. But we have more indications coming. We've got priority review in second-line BCC as well as priority review in non-small cell lung cancer. That priority review is important because we think it reflects the fact that we have some differentiation in terms of the patient population that we studied. And frankly, we think of Libtayo as potentially best-in-class. And we'll have to see how it all plays out. But it's already running at close to $100 million in the third quarter. So big opportunity with these new indications coming. And frankly, cancer, as you know, very depressingly, despite all the advances in immuno-oncology, there's just so much more that needs to be done. There are cancers that are not responsive, and they are cancers that even if they are responsive, only select and small populations respond. And so our pipeline of over 12 candidates has the potential to address many, many cancers, and George is going to get into this in great detail. Let me turn quickly over to our efforts in COVID. I'm just going to say that George will get into the science behind it, but we, as you know, had an emergency use authorization for our cocktail. We do believe the cocktail is very important. You've heard about all sorts of variants out there, and we think that having a cocktail makes it more likely you'll be able to deal, as we have evidence for, for variants that might pop up because it reduces the likelihood that a single variant can become resistant to both antibodies in the cocktail. And frankly, having a cocktail means less likely that you're going to select the variants. And we begin -- we can see the danger in this. So we're strongly believers in the cocktail. We had net product sales in the fourth quarter of $144 million. That's a little bit lower than some of you might have been expecting, but that's just a timing event, we think, because we'll be delivering those products in the first part of this quarter. It's approved for recently diagnosed mild to moderate patients. And the initial purchase was for 300,000 doses, but we're in negotiations for additional doses. We think there's substantial demand for this cocktail. We're in the early days of working out some of the kinks in terms of making it easier for patients to get it. We're collaborating with Roche, who's been working and -- on getting approvals and dealing with the demand outside the United States. They should be coming online in the near future. And frankly, we have a lot going on, which George is going to talk to you about. We do have up and coming a PDUFA date on evinacumab, which we think adds and addresses an important need in homozygous FH, and it's going to help us build our rare disease strategy, leveraging cardiometabolic expertise. And finally, this is a slide that you can look at, at your leisure. It has to do a little bit with the regulatory submissions that are going on. And you can see there's a steady stream of more things coming. And so we are very pleased, really pleased, how 2020 was a transformational year for us. We had growth in our -- by good commercial execution despite the problems. We showed what our pipeline can deliver, with EYLEA continuing to grow at double digit; with Dupixent hitting its first $1 billion quarter; and, frankly, the pipeline and innovations being leveraged to help deal with COVID. I'm going to stop now so I'll leave ample time for you to hear about the most important stuff, is how well is the research and development that leads to these products coming along. George?

Thanks, Len. And as you said, 2020 was, in so many ways, a remarkable year filled with significant accomplishments and pipeline advances across all stages of our diverse and growing portfolio. Can we move, please, to Slide 18? And I guess I'm still seeing Len on my image. I don't know who's in charge of doing all this. But hopefully, you guys are all seeing me, and you can turn to your Slide #18, which gets to the core of all -- where all of our efforts start and where they come from. Most importantly, it starts with an incredible group of dedicated people who have worked tirelessly and, most importantly, innovatively, over the last 3 decades, creating and developing the core technologies and capabilities that power everything we do, in as turnkey a manner as possible, that allow us to produce repeated breakthroughs across different therapeutic areas. These technologies start with functional genetics approaches in humans coming from our Regeneron Genetics Center, which has now sequenced over 1 million humans, all linked to their detailed electronic health records, creating arguably the largest big data set in the human sequencing arena. Our technologies also include a parallel high-throughput functional genetics approach in mice, which we call VelociGene. It's quite remarkable that the world's leading human and mouse functional genetic efforts reside in one company. And this results in an incomparable competitive advantages. Our technologies also include our world-leading platform to deliver fully human antibodies that revolves around the mouse we created with a genetically humanized immune system that we call VelocImmune. As well as related technologies that power our capabilities to make several different classes of bispecifics which we call Veloci-Bi. These core technologies include additional proprietary capabilities for the discovery, development and manufacturing that we repeatedly leverage to develop life-changing medicines, from EYLEA and Dupixent, that you already heard a lot about, to our oncology pipeline. But perhaps the power and speed of our technologies has been most dramatically demonstrated in our ability to rapidly respond to emerging epidemics, like Ebola and coronavirus. So please turn to Slide 19. In 2020, our antibody cocktail for Ebola became the first treatment for Ebola to be approved by the FDA based on its ability to save lives, as demonstrated in a remarkable clinical trial carried out in the Congo. But as we all know too well, 2020 also brought the devastation and horror of a truly worldwide pandemic. And once again, our people, working with our technologies, responded by producing a corresponding antibody cocktail for COVID-19. Using our technologies and with our people working tirelessly, we compressed time lines from years to months. And not only did we get to the clinic in record time, our cocktail was the first treatment of any kind to, in the clinic, prospectively demonstrate statistically significant and profound antiviral activity against the virus with rapid and robust reductions in virus load. And we were also able to demonstrate that our cocktail reduced the risk of recently infected patients from progressing to more serious disease by as much as 84%, which formed the basis of the FDA granting an EUA for high-risk patients in the [ non- ] hospitalized setting. And we also recently announced compelling initial clinical data in the hospitalized patient set. I am sure you have all heard that there have been problems getting our antibody cocktail to the many, many patients who could benefit, and we could -- we are working very hard with the government to rectify this situation. Obviously and unfortunately, millions will continue to be infected and at risk over the next many months, and perhaps years, until vaccines can be used to help create widespread immunity. And we will do our best to make our cocktail available to those who could potentially help -- to the many who we could potentially help with our cocktail, for whom the vaccine will be too late. Please move to Slide 20, okay, which shows the comprehensive ongoing clinical development program for our COVID-19 antibody cocktail, in which we have already demonstrated -- we have already enrolled close to 15,000 patients. And we hope we will continue to demonstrate the value of using our cocktail as a bridge treatment until the point that vaccines help the world hopefully achieve widespread immunity. I should note that our cocktail approach has resulted in a treatment that thus far should still be active against the major variants described in the United Kingdom, in California and in South Africa, but that we are also working on additional cocktails should the virus continue to mutate and escape. Please go to Slide 21. While Ebola and COVID-19 have provided for dramatic examples of the power and speed of our Regeneron approach, we applied the same principles, technologies and processes across our entire platform and pipeline, resulting in a very deep, broad and diverse set of approved products and investigational medicines. We are really unique in the biopharma industry in that our pipeline is largely driven by our internal discovery efforts and platforms, and that we do not depend on one therapeutic area or one pipeline drug for the long term. We have multiple opportunities in large and specialized therapeutic areas to create our long-term growth outlook. While we could speak for many hours on these programs, my remaining remarks today will focus on Dupixent and on oncology. So please turn to Slide 22 now, which shows Dupixent's progressing and expanding clinical development program. A long time ago now, we proposed that all type 2 inflammatory diseases, that is the so-called allergic-related diseases, like asthma and atopic dermatitis and others, might all be driven by the same 2 sister cytokines, that is interleukins-4 and interleukins-13. In fact, it is our own clinical trials in these diseases with Dupixent that has definitively proven and extended this hypothesis. Our approvals in atopic dermatitis, in asthma, in chronic rhinosinusitis with nasal polyps, define the fundamental role of these 2 critical interleukins as the drivers of these 3 important type 2 diseases which already encompass more than 3 million people in need with moderate to severe versions of these diseases. And our clinical efforts with Dupixent continue to progress and expand with pivotal trials for 8 additional type 2 diseases that are not currently in the label and could address disease in nearly 1 million additional patients in the United States alone. Slide 23, please, which shows an important additional opportunity for Dupixent as well as for another of our pipeline antibodies which targets interleukin-33, which together, could provide for a two-pronged approach against chronic obstructive pulmonary disease, or COPD. Like many diseases, COPD appears to be a heterogeneous disease, with some patients suffering from more of a type 2 version of this disease, and others, not. As we reported previously, Dupixent achieved a prespecified efficacy milestone in interim analysis of our first Phase III study in type 2 COPD, which encompassed a combination of a reduction in exacerbations and improvement in lung function. And meeting this efficacy milestone triggered for us and our Sanofi partners to initiate a second Phase III study of Dupixent in COPD. Furthermore, our human genetics data indicated that our anti IL-33 antibody could also help COPD patients, but perhaps a different subset. And indeed, our initial results from our proof-of-concept Phase II trial suggest that blocking IL-33 could be especially useful in a different subset of these patients, the former smoker COPD patient subgroup. There is incredible unmet need for new treatments for COPD, and we hope that Dupixent and itepekimab fulfill their promise for these different subsets of these patients. Slide 24 summarizes the Phase III programs for Dupixent and itepekimab fulfill their promise in COPD as well as the significant unmet need. As many biologics have failed to demonstrate a benefit for this population, we are -- we all need and hope the promise of Dupixent with data readouts in 2023 for Dupixent and 2024 for itepekimab. Moving on to our oncology portfolio and starting with Slide 25. Our entire strategy in oncology centers around approaches to allow us to compete, enhance and extend the benefits of targeted immunotherapies in cancer. Slide 26, please. If you turn to this slide, it tries to outline what makes Regeneron unique in our platforms. As I described earlier, it is these platforms which allow us to generate and combine antibodies, as well as several different classes of bispecifics, against many cancer targets. While others in the field aspire to extend treatment benefits to more patients using individual therapies, nobody has -- in the industry has the toolkit that we have that offers the combinatorial flexibility that we have. Libtayo, our approved PD-1 antibody that Len has already told you about, is foundational to our approach, where our portfolio consists of multiple classes of bispecifics in addition to Libtayo, not only these additional checkpoint inhibitors, but multiple classes of bispecifics. Beyond our own pipeline, we have the ability to combine our novel modalities with those coming from many of our partners as well. So with this powerful toolkit, well positioned for combinatorial possibilities, we really believe we have the ability to compete, enhance and extend the benefits of immunotherapy to broader patient populations to those that benefit today and so many in need. So Slide 27, if you can turn to it, summarizes how our technologies, which were so foundational to build our pipeline, also create these novel bispecific classes that allow us to really do new things in cancer. In particular, we have created bispecifics that work like nature does, to mimic the normal signals that T cells use, most notably: Signal 1, that's mediated by our CD3 class of bispecifics; and CD2, that's mediated by our so-called co-stimulatory class of bispecifics. And it's our large collection of bispecifics, of these and other different classes, that allow for the large amount of combinatorial flexibility that really distinguishes our approach. So Slide 28, if you can turn to it, summarizes this unique capability of combining different classes of reagents, one that would allow checkpoint release, such as Libtayo being the first in our class; CD3 bispecifics that activate Signal 1; and costimulatory bispecifics that activate Signal 2. We're mimicking what nature normally does to optimally activate T cells for their ability to both recognize, be released and to actively kill tumor cells, which we think will provide enormous opportunities to really benefit patients. If you can turn to Slide 29, it summarizes our first example of our CD3 class of bispecifics, which is proving to be potentially best-in-class for this targeted agent. This single bispecific is effective against both indolent and aggressive lymphomas, including patients who have failed CAR-Ts. It's an off-the-shelf reagent administered in the outpatient setting. And over 350 patients have been dosed to date across the program with durable responses, including over 3 years now, with good tolerability. As recently presented at ASH, it has among the most promising efficacy data in the field in both indolent lymphoma, that is relapsed/refractory follicular lymphoma on the left; in more aggressive diffuse large cell B-cell lymphoma in the middle; as well as having profound [ activity ] in patients who have progressed and failed on CAR-T therapies on the right. So obviously, we're very excited not only about this first CD3 class of agents, but also its ability, as I'll be telling you shortly, to combine with additional classes of bispecifics to even extend on this initial efficacy that we're seeing. Very promising right now. The next slide, Slide 30, summarizes data as we recently presented at ASH for our second example of a CD3 bispecific. One targeted against BCMA for relapsed/refractory multiple myeloma. Also as disclosed at ASH, this BCMA has also demonstrated very profound and competitive efficacy profile in a heavily pretreated, vulnerable, multiple myeloma patient population, with deep responses across all dose levels, culminating with the highest responses and response rates at the highest levels with manageable tolerability profile. We're currently enrolling patients in our potentially pivotal Phase II portion of our program. And we're particularly excited that this bispecific is part of our partnership with Sanofi with obvious potential synergies not only with our additional classes of bispecifics, that I'll get to shortly, but also with their CD38-targeted isatuxiumab program. So please now move on to Slide 31, which highlights the combinatorial opportunities that we have by combining our different classes of bispecifics. I've already told you about our CD3 bispecifics that are already in the clinic and demonstrating very promising, perhaps best-in-class, efficacy profiles. I've also told you that we've created a second class of co-stimulatory bispecifics. And this slide shows the dramatic synergies that one sees when one combines a CD3 bispecific, this is the one that's targeting a lymphoma, shown in green; with a costimulatory bispecific in red, which on its own has very little activity. So when you combine them, as shown in blue, highlighted by the red arrow, you can almost completely ablate certain very aggressive lymphomas and cancers in preclinical models. We are now moving these combinations of bispecifics in the clinic, and we hope to improve and build on the exciting profiles and efficacy we're seeing with our CD3 bispecifics by enhancing their efficacy and their ability to help patients by combining with the CD3 class of bispecifics and, additionally, with future classes of bispecifics as well. So if you move to Slide 32, it highlights the point about combining costimulatory bispecifics as well as combining them not only with CD3 bispecifics, but with checkpoint inhibitors, can really enhance patient benefit. This slide summarizes combination programs that we already have in the clinic or which will soon be in the clinic, combining our costimulatory bispecifics with Libtayo to really potentially enhance patient benefit in a variety of solid tumor settings as well, as what I've been showing you with the liquid tumor settings before. So if you can move to Slide 33, it provides a quick summary of the diverse oncology portfolio, which is really based and founded on this notion of combinations which are only possible because of our foundational technologies that produce either the individual antibodies or the various classes of bispecifics, from the CD3s, to the costimulatories, to more. So Slide 34 once again emphasizes the potential combinations, those that are currently being treated in the clinic already or soon to be entering clinical testing. And we really look forward to advancing these combinations and hopefully demonstrating potential benefit to the many patients who need them. So I just wanted to end by focusing on our unique collaboration approaches. We don't really in-license products, but we establish relationships with companies that we believe we can really work together with to really enhance and extend our own capabilities, really empower what they bring to the table by adding our own toolkits and our own capabilities. These include a number of important collaborations that we think can create the next generation of genetics-based medicines. Many of these depend on our genetics capabilities and our abilities to work hand-in-hand with these important partners to create the next generation of therapeutics. So if you can turn to the last slide, which is Slide 36, it just summarizes some key upcoming milestones. And with that, I'll end my portion of the presentation.

All right. Terrific. So we have about 10 minutes left for Q&A. [Operator Instructions] We have one already. I want to start, though, on the COVID front, and just ask you guys -- and welcome to Marion and Bob as well. Just ask, what you're seeing in the real world, of where antibody therapies are being used, and why you think they're maybe not being used more given the obvious surge we've been seeing in cases for some time now.

Well, this is George. Maybe I'll take that on. I think that it's a problem. As in any situation, with a rollout in real time in the midst of an emergency, I think that we need to work much more closely with the government to figure out much more effective ways to get this to the patients. We know that every day, there are hundreds of thousands of people getting infected that fit the profile where they could benefit from the antibody therapies. It could slow down very significant the progression of these people into hospitals and into more severe states. We think it would be a very important component, because right now, the vaccine is not helping any of these people. The only thing that can really help these people right now that's been demonstrated to are these antibody therapies. And we, as a society, have to do a much better job of getting these therapies into these patients where it could really make a difference and make a difference on their prognosis and also greatly impact the health care system as well, which is under stress right now.

Okay. And probably for you again, George. We get a lot of questions, we're very interested in your costim program within your oncology franchise. When -- what are the time lines, think early on, associated with this? And when might we be able to see kind of an early peek at how these evolve in the clinic?

Well, as with any new class of agents, we work very carefully with the FDA to make sure that we move forward safely. But as I've already shown you in the presentation, we now have a number of different programs, 3 different programs, where we already have costims either in or about to enter in the clinic. And we are very hopeful that, over the course of this year, we will start seeing signals that will be able to suggest to us, and to you when we share the data, that these costims really have the sort of dramatic ability to take patient benefit to the next level as we have been able to see in the preclinical models.

Okay. And then with your first generation of bispecifics, what's the latest with the partial clinical hold for 1979? What do you have to do to remove that?

Well, we have responded to the FDA with an approach that we hope, we feel, will fulfill their need and that will allow us to go back to actively treating patients in this very important program.

All right. And then sticking with the oncology theme, maybe for Marion. How should we think about the pending Libtayo launch in lung cancer? And maybe added to that, the potential impact your chemo combo study could have on market dynamics.

Sure, Cory. Let me comment first on the lung launch. We look forward to approval, and certainly not just for lung for Libtayo, but also for basal cell carcinoma, hopefully coming up shortly as the PDUFA date approaches. And I think the way we think about it is that oncologists are very interested in the clinical profile of Libtayo. Many have come to see the amazing results and durability in cutaneous squamous cell carcinoma. We look forward to the lung launch, the differentiation of our product and the ability to offer choice in this really important category for oncologists. Obviously, future combinations give us the opportunity to broaden our potential to help more patients, and we look forward to that clinical data.

Okay. And I have an investor question here that follows up on lung cancer, and probably for George. It's are there any specific [ elements ] versus the analogous Keytruda trials you would call out in your front-line non-small cell lung cancer trial to assess whether the outcome of this study will be more like that of nivo versus Keytruda?

I'm sorry, but you zoned out. I couldn't hear the question.

I'm sorry. Here we go, first Zoom moment of this. Are there any design elements of your front-line lung study versus the analogous Keytruda trials to assess whether the outcome might be more like that of nivo versus Keytruda?

I'm a little confused by the question. So in the front-line lung study that we just described over the last -- a few months ago, our results were in very line...

George, I think he's referring to the upcoming study, whether -- is there any differences in our chemo combination study that would make people believe, or you believe, that it would be closer to Keytruda than it would be a nivo-like effect? I believe...

Well, all right. Like I said, I'm very confused only in that the first-line lung cancer studies is monotherapy, that we already showed, was that the results were much more Keytruda-like. Because as you all know, nivo has failed to demonstrate a benefit in the first-line lung cancer study as monotherapy. So that is the strongest data that suggests that Libtayo is behaving much more Keytruda-like than Opdivo-like, which has failed to show a monotherapy benefit in the first-line lung study. And as you know, our patient population, as Len already mentioned, was a broader and, in some ways, different population. And some could actually view our data as best-in-class data at this point.

Okay. Another investor question that we have here on the oncology front, but back to bispecifics. Any plans to evaluate Regeneron 5458 in the subcu formulation? And what would be an ideal combination for 5458?

Yes. I think that, that's actually already in the plans and in the works, to be initiating a subcu formulation. And there are multiple combinations that we've already talked about. As I said, one is simply an important combination with our partner and their CD38. Another important combination is with our follow-on costims. So we have an assortment of myeloma-specific costims that will be able to be combine to extend and enhance the benefit that's seen already with the CD3 bispecific by itself. So we think combinations of biologicals, either in the CD38 class or in the upcoming bispecific costimulatory classes, will be very exciting, important combinations that could really take the BCMA class to an entirely whole level and change the paradigm and -- the treatment paradigm for myeloma for patients.

And then, George, in our last minute we have left here, so if you could just answer this one quickly. From a development point of view, how do you think you might shift your clinical priorities once your subcu formulation for bispecific is ready for the clinic? I mean, do you still see a viable path for IV? Or do you expect the market to all trend to subcu?

Well, we are obviously hoping that subcu administration will become a much more convenient and, there's some evidence that suggests that it might even be, a safer way of actually delivering these kinds of potent biologicals. So we're certainly moving into that direction.

Okay. It's unfortunately all we have time for. I want to thank you guys very much for participating today. Look forward to speaking with you and hopefully seeing you very soon.

Thank you, Cory, very much.

Thank you, Cory.