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

Great. Good morning, and once again, welcome to the 40th Annual, and unfortunately, second-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 are the company's cofounders, CEO, Len Schleifer; and CSO, George Yancopoulos. Please note that following this presentation, we'll go right in to Q&A, where you can submit questions via the Ask a Question button on your conference portal and we'll work in as many as we can, time permitting. So with that, let me turn things over to Len.

Thanks, Cory. We've been getting introductions for 30 years, and that's one of the more stellar ones. All kidding aside, we were hoping for something like live from New York, it's Regeneron. And anyway, we are here in New York. And remarkably enough, we're here for the second time at the epicenter of this scourge, known as COVID. We'll have some stuff to say about that a little bit. But it is good to be here with you, all kidding aside, at the conference. Even if it's virtual. We hope next year, we get to see you all live. As I go through the slides, I'll be referencing slide numbers that I hope will appear on the screen. If not, you can find them on our website and follow along. Let's turn to the next slide, if you will. That is our ever-complex forward-looking statement slide. And I would like to remind you that remarks we make today will include forward-looking statements. Each forward-looking statements is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. And a more complete description of these and other risks can be found in Regeneron's SEC filings. We don't undertake any obligation to update any forward-looking statements. And if you need further information, you can contact us. And if you need to understand how we go from GAAP to non-GAAP measures, you can -- that we'll be talking about today, you can find those transformations, if you will, in reconciliations at the end of our presentation. Let's jump right in. If we can go to the fourth slide. And I have to say, I think we're pretty proud all of us at Regeneron that over the last 3 decades, we have built a company that uses the power of science to bring medicines to patients over and over again. We think we are positioned to thrive on exactly that mission. We're executing on core competencies. We have a remarkably growing and diversified product portfolio and a best-in-class, well-diversified R&D pipeline. We're continuing to invest in the company, positioning Regeneron for long and sustained growth. We're advancing our pipeline forward. We utilized human genetics that George is going to tell you a lot about. Tremendous forward-looking investment, I think, that was made there to create the Regeneron Genetics Center, which advances drug target, drug discovery and drug development efforts. George will be looking a little bit more to the future to explain how we're broadening our efforts by supplementing our homegrown pipeline with external innovation, novel modalities, CRISPR, siRNA as examples. And we think we'll have the opportunity to create significant benefits for the company's efforts in the near, mid- and long-term future. In totality, we're very confident in our trajectory. And the future, we think, remains bright. If you turn to the next slide, we can review quickly some of the accomplishments of 2021. And looking back, the business performed extremely well. Through the first 3 quarters of the year, we had a 20% top line growth, and that's excluding COVID-related revenues, which is a testament to the strength of our growing and diversified core business. EYLEA, which we preannounced fourth quarter U.S., net sales today had substantial growth. In its tenth year, tenth year on the market, it's still growing 17% last year over the prior year. That's quite remarkable for a product of this size. And I think it's a testament to the safety, efficacy and experience that patients and their doctors have had with EYLEA over the past decade. Dupixent, continues to demonstrate substantial growth in global net product sales are annualizing based on third quarter sales at a $6.6 billion run rate. We don't yet have fourth quarter sales with Sanofi we'll present when they give their end-of-year report, sometime coming up, I think, later this month. Regeneron responded to the pandemic. We think, in a robust fashion, we were able to delivered several million doses. Treating individuals with REGEN-COV cocktail that generated $5.8 billion in net sales in the U.S. in 2021. So I think as we've demonstrated, our overall business is growing with increasingly diversified revenue and cash flow streams, and we continue to deploy substantial cash on our internal pipeline, on R&D collaborations and finally, even returning cash to shareholders via stock buybacks. We also made significant progress advancing our world-class R&D pipeline across all stages and ranges of disease, which George will discuss some upcoming future drivers of our business. If you turn to Slide 6, please. On the next few slides, I'll discuss some of the key business drivers, starting with EYLEA. As I mentioned, after 10 years, post launch and millions of injections later, we continue to view EYLEA as an enduring product with significant future opportunity. We preannounced, as I just mentioned, our U.S. net sales, which grew 15% year-over-year in the fourth quarter to $1.54 billion. Total 2021 EYLEA net sales were nearly $5.8 billion, which grew 17% versus the prior year. EYLEA's track record on efficacy, safety, durability, we still think positions it well for continued growth despite emerging competition. High dose aflibercept, which is known as 8 milligrams of aflibercept, the active ingredient EYLEA, has the possibility to drive continued growth beyond what we get from EYLEA alone. Phase III studies are expected to read out in the second half of this year. Turning to Dupixent on the next slide. Looking at our [indiscernible] indications, you can see that Dupixent is delivering on our vision of transforming the treatment of type 2 inflammatory diseases. And what's remarkable is that we are in a high-growth, high-revenue state but very low penetration. And therefore, with less than double-digit penetration, 110% in our current indications and our new indications, we think that the growth prospects are truly outstanding for Dupixent. As I mentioned, it's annualizing at a $6.6 billion run rate based on the third quarter of sales. And if you compare that to other biologic launches, it compares quite favorably. Next slide, please. On Slide 8, you can see that Dupixent, we will continue to invest. We are creating a tremendous group of type 2 inflammatory diseases that Dupixent can address its safety, its efficacy and its ability to actually treat people who might have comorbid. Somebody who has both asthma and atopic dermatitis, for example, positions us very well for a strong, long-term growth. 2022 is shaping up to be an important year with many new indications and readouts and potential submissions in diseases such as eosinophilic esophagitis and others. Looking beyond 2022, we have several additional Phase III trials ongoing in new opportunities with the largest unmet need being in COPD. Next slide sort of summarizes the opportunity of Dupixent in COPD. And you can see we have a two-pronged approach there, working with Sanofi on our IL-33 antibody as well as Dupixent addressing different segments of the COPD opportunity. There are large Phase III programs for both of these molecules enrolling, and we expect results in 2023. We've already had some preliminary earlier-stage results, which have been reported in the medical literature. Turning to the next slide. Let's take a look at how we did with COVID. Our teams put in extraordinary effort. As I mentioned, we're live from New York here in the epicenter. And we -- this is the second time we're going through a surge of cases and our teams operated in the backdrop of this, their families, themselves at risk for getting sick. They continue to work on antibodies to -- that brought forth REGEN-COV as well as our next-generation antibodies that will address Omicron. This morning, we announced that we completed our latest government supply contract with delivering 1.1 million doses in the fourth quarter. In 2021, overall, we delivered over 2.8 million doses to the U.S. government and recognized $5.8 billion in net sales in just the U.S. alone. Obviously, we've been working outside the U.S. with Roche. And so we're trying to address the global needs. George is going to discuss our next-generation efforts against Omicron. And the enduring opportunity, most importantly, I think there's some confusion that George, I hope will explain, that we're going to -- we hope that the enduring opportunity is for antibodies to be given in a preventive, protective mode for the immunocompromised. Next slide, please. If you take a look at where we spend our money, I think we've got our priorities right. We are disciplined in what we do. We don't -- we're not formulaic. We allocate capital in the first priority to our internal R&D pipeline, which has been quite substantial in its productivity as well as our investment. We also allocate capital to collaborations, whether it be Alnylam, CRISPR and a host of others. We try and be very choosy about the people we work with. And so far, we've done very well, I think, in advancing together, new technologies, which I think will serve the company well, and George will address. Let me just make a couple of quick comments before we turn this over to George, saying 2021 really was an exceptional year, but we're even more excited. We've been doing this together for a very long time for more than 3 decades. I can tell you we're as excited about '22 and beyond as we've ever been about the company. People say that, but we really feel it in our guts, this fire in our bellies, and the whole company really wants to continue to realize our potential. So with that, I'm going to turn the presentation over to George, who will discuss some of our technologies and how our oncology and genetic efforts will play into the success of our business, we hope over the years to come. George?

Thanks, Len. And first of all, I'd like to add my appreciation to all of our people at Regeneron and throughout our great biopharma industry for continuing their incredible dedication and efforts during the challenging times of this ongoing epidemic, not only to try to bring forth important weapons to fight back against COVID-19, but to continue their efforts across the board against all forms of disease. I think all these people should be considered essential frontline workers and heroes. Okay. Slide 13, please. For us, all of our efforts begin with the innovative new technologies that we have been developing and enhancing, involving many years of ingenuity and investment. An important principle that we repeatedly applied is that we aim to turn all of our technologies into turnkey plug-and-play platforms that once we develop the platform, we can easily then modify the components to change the specific target, which provides us a tremendous advantage. We did this first for platforms that deliver TRAPs like EYLEA or antibodies like Dupixent or REGEN-COV. And more recently, bispecific antibodies, such as those that we have for lymphoma and myeloma and in ovarian cancer as well as our so-called costim bispecific antibodies, all of which I'll tell you a little bit more about. Our ability to subsequently combine and mix all these agents in intelligent and creative ways, provides for an exciting portfolio with breadth across a variety of therapeutic spaces, from cancer to infectious disease. Please turn to Slide 14 now. A few years ago, we began to apply the same principles that gave us antibodies and bispecifics and costims to instead create the genetics medicines of the future. Basically, we took the lessons that we learned in becoming one of the world's leading antibody and bispecific companies and applying them to genetics. We started with our Regeneron Genetics Center, which gave us an unprecedented ability to explore human genetic variation through mega scale human sequencing. We have sequenced more than 2 million volunteers to date, representing almost half of all humans ever sequenced. But all of our sequence volunteers are linked to their electronic medical records, creating perhaps the world's largest and most valuable genetics-based big data, data set and which have already led to import new genetics-based drug targets and neurogenetics insights into clinical trial design. We then took all of this from the Regeneron Genetics Center, and we strategically incorporated a series of selected partners with synergistic genetic capabilities such as Alnylam, that allowed us to develop an siRNA platform; or Intellia, delivering us a CRISPR-based gene knockout and insertion approach. Together with this significant internal effort in developing novel approaches to viral-based gene delivery, we believe we are becoming leaders in the future of genetics medicines with multiple exciting clinical and near clinical programs. Moving to Slide 15, please. I wanted to touch on an example of how our platforms can be powerfully applied even to new challenges that had perhaps previously not been anticipated, such as combating an infectious disease pandemic, which is still unfortunately on top of everybody's mind. From the beginning, we fear that the virus will continue to evolve and that new and more resistant variants would emerge. And so we use our antibody platforms to create what we believe is the largest and most diverse collection of antibodies targeting SARS-CoV-2, positioning us to continue our fight against this disease as the virus evolves. Slide 16. Regarding the Omicron variant of the COVID-19 virus. We have identified multiple next-generation monoclonal antibodies that are highly active against Omicron and other variants of concern. We have begun to scale up production, and we anticipate that these next-gen antibodies will enter the clinic later this quarter. We continue to productive conversations with regulatory authorities to establish our clinical path forward for these next-gen antibodies. And as Len said, in the long term, if the virus becomes endemic, as many anticipate, we and others realized that the millions of immunocompromised people in the United States and across the world who don't adequately respond to vaccines, will be left vulnerable and unprotected. We foresee REGEN-COV and other monoclonal abides playing a significant ongoing role in protecting this highly vulnerable patient population, and we are working hard to be there to provide such solutions in the future. Slide 17. Now I'd like to move to highlight another key growth driver for Regeneron going forward, which also starts with our turnkey platforms, our expanding oncology portfolio. We have made considerable progress to unlock the potential of immunotherapy. First, with our approved anti-PD-1 agent, Libtayo, and we have advanced many additional candidates into the clinic, additional antibodies, bispecific antibodies as well as what we call our cost inventory bispecifics, which provide for an impressive set of intelligently designed combinatorial opportunities. And Slide 18 is intended to highlight the combinatorial potential for these various agents to truly unlock the potential of immunotherapy. For example, we can combine our CD3 bispecifics, whether it be for lymphoma, myeloma or ovarian cancer, with our co-stimulatory bispecifics. Or we can also combine each of these with Libtayo, all of which have the important potential as demonstrated in preclinical models, to significantly enhance potential efficacy. And many of these combinations are already in clinical trials. Slide 19, which summarizes our recent discussions and data releases around the ASH 2021 Conference. Odronextamab, our CD3xCD20 bispecific, demonstrates potentially best-in-class efficacy across both aggressive and indolent lymphomas, including patients who have failed multiple therapies, including CAR-T therapy. After implementation of our recently revised stepped-up dosing protocol, the cytokine release syndrome, or CRS event rates, are now comparable or even lower than what has been observed in the field. And we anticipate that these observed low rates of CRS will guide the future hospitalization requirements in the real life clinical practice setting. Regarding REGN5458, our BCMAxCD3 program in myeloma. We are encouraged by our progress in the data presented at ASH, which also suggests potential best-in-class efficacy, with a desirable safety profile. We are on track to file both these programs later this year as well as to move to additional multiple studies, including earlier line settings and perhaps most excitingly, initiate combination studies with our lymphoma and myeloma costim agents, which could further enhance the already impressive efficacy that we're seeing here. Moving now to Slide 20, please. In our earlier stage solid tumor efforts, we now have several novel experimental treatments in the clinic, many of them bispecifics of novel design with more coming quickly on their own or in combination with current candidates, all as a variety listed here. Regarding our METxMET tumor program. We are pleased to report that we are now observing early signs of clinical activity in the MET exon14 skip mutation patient population as well as in patients with MET protein overexpression. This is very exciting since it validates our hypothesis, and it also bodes well for our next class agent, or METxMET antibody drug conjugate program, which is now actively enrolling and treating patients. We're hoping to share these preliminary exciting data with the naked METxMET bispecific at a medical meeting in the second half of this year. More imminently, we're also excited to share initial data from the dose escalation monotherapy study of our MUC16xCD3 bispecific in late-stage ovarian cancer, which we'll be sharing at a medical meeting in the first half of this year. As a reminder, this agent is also enrolling cohorts in combination with both Libtayo as well as with our novel MUC16xCD28 costim candidate, very exciting possibilities of new standards of care in the ovarian cancer space. Similarly, in prostate cancer, our PSMAxCD28 costim REGN5678 is steadily progressing through dose escalation in combination with Libtayo, and we are still expecting to share some initial data from this clinical trial later this year. The other PSMA targeting bispecific PSMAxCD3 is now also enrolling patients. This agent will be tested once again as a monotherapy, but also in various combinations with costim as well as with Libtayo. In summary, we are pleased with the continuing expansion of our footprint in oncology, and we are very excited to soon share some of these groundbreaking data in difficult-to-treat solid tumors that have had historically low response rates to date with immunotherapy. Slide 21, please. Slide 21 provides an expanded view of the abundance of molecules and combinations, which we are uniquely positioned to advance through clinical development in oncology. Next Slide 22, please. I'd like to briefly elaborate on our future vision involving Regeneron Genetics Medicines. With the Regeneron Genetic Center as our backbone and our growing external partnerships with like-minded companies, such as Alnylam, Intellia and Decibel, we are well-positioned to be at the forefront of the next wave of biotech innovation. While still in its infancy, we think that these groundbreaking technologies, such as siRNAs, CRISPR-based therapies as well as virally directed gene therapy, have the potential to be just as large as the biologics are today. On Slide 23 is a summary of some of our near and longer-term opportunities emerging from our Regeneron Genetic Medicines capabilities. Our strategy involves creating synergistic partnerships that can synchronize with what we can do internally and which can help further empower and build on, resulting in world-leading turnkey therapeutic solutions that can yield entire pipelines, all going after targets elucidated and validated biogenetics, giving us the highest chance of success in the clinic. Slide 24. You can see the current clinical stage and improved products, all stemming from the technologies and efforts that I've just described to you as well as our -- some of our novel collaborations and combinations. Slide 25. As you can see on this slide, over the next several years, we see a wave of potential regulatory submissions. There are many opportunities to expand our existing product portfolio with new indications. As we look out further, we see the potential for approval of new molecules that are now in the clinic, which, if approved, will further diversify our growing portfolio. And ending with the next, Slide 26, which summarizes anticipated Regeneron milestones over the next year. As you can see, there is no pause at Regeneron, and we are excited about what next year and beyond will bring for our innovation and most importantly, for patients. With that, let's turn to Slide 27 and turning it over to Q&A. I'd like to thank everyone for their attention, and hand it back to Cory. And note that Marion and Bob will join Len and me for the question-and-answer session.

Great. Thank you, George, and thank you, Len. Appreciate the comments as always. We have about just under 15 minutes left for Q&A. A number of topics to get to. I have a couple of questions in the portal, but just a reminder to our audience, you can submit questions, and we'll work them in as best we can. So I guess just to start on the subject of COVID, so many questions on it. Can you talk a little bit more to the longer-term strategy with your antibody cocktails? And how much of a commercial focus is there for this in '22? And how do you see the opportunity evolving from here with oral options and boosters? It sounds like it's that immunocompromised population that's really going to make up the bulk of this in the future. Is that the right way to think about it?

Yes. I mean from a commercial perspective, I think that, that is the exact right way to think about it, Cory. I think people haven't really focused on that. You need to segment this market to the treatment market and the prevention market. The treatment market is going to be rather crowded. Obviously, you're going to have the orals. You'll have other monoclonals. And maybe the best thing you'll have is vaccines to obviate the need for treatment. But I do think there's a role for monoclonals in the treatment setting. But the big and more enduring role is clearly in the prevention setting. I think that you have millions of people who, no matter how many vaccines you give them, they don't respond. These are people who are getting cancer chemotherapy, people who have innate immune deficiencies, people are taking drugs that knock down their ability to respond to a vaccine. All of these create a huge unmet medical need because vaccines -- they don't get the benefit of a vaccine. And I think there is a real steady opportunity to help them as long as this vaccine remains endemic, which, as George mentioned in his remarks, many people feel will be for quite some time.

Well, to add to that, I think that we've all seen that the initial hope and dreams that vaccinate enough people, and we put this whole pandemic behind us. We're seeing that, that dream is really fading. And I think the future that many people foresee is to protect the vast majority of the population, we will require frequent boosters perhaps twice a year. This is what people are estimating for the vast majority of the population. But as Len said, and very important, perhaps the most vulnerable part of the entire population, the immunocompromised, which represent about 5 million to 10 million people in America alone, don't respond well or at all to vaccines. So if you're going to be giving everybody else boosters twice a year, what are you going to be doing with these people who are more vulnerable because they don't have any ability to fight back to the virus, either on their own or in response to the vaccine? And this is where we think, essentially give them a surrogate immune system, a surrogate antibody response, such as we can with our monoclonal antibodies can really help these individuals. So I think many people are seeing in the future, an endemic situation with the need for frequent boosters for the general population and what we see is correspondingly a need for the immunocompromised, the 5 million to 10 million Americans, that fit in that class and the many more throughout the world, that they may be needing frequent injections. Let's say, 2 to 4x a year of the antibodies such as the next-generation REGEN-COV. And we are continuing to try to keep up with the virus. As we said, now have potent new cocktail opportunities that can deal with Omicron and future variants. And we're going to continue to develop these so they will always be available to the patients who need them as the time occurs if new variants emerge.

And just to add one point to that, that it's not just that these people need to be treated, I think there's some reasonable scientific evidence, George, is probably more positioned to comment. That this is an incubation place for new variants if you don't treat these people because they can sort of partially fight things off. George, maybe you want to make a comment about that?

Yes. It's a very important point. And many have, in fact, argued that Omicron arose in an immunocompromised person. That is somebody who can only partially fight back against the virus, that allows the virus to continue to evolve and mutant and create multiple mutations within the same patient. So that, if anything, in terms of the future and in terms of preventing future, even more dangerous variants trying to treat effectively and prevent ongoing viral replication in immunocompromised population, may be as a society of one of the most important things that we have to do. And since vaccines don't work there, antibodies are for perhaps the only approach that really will work there.

Very interesting point. All right. We have a number of questions in here on EYLEA. Let me start with if you could just kind of set your expectations for the high-dose EYLEA program ahead of the anticipated readout in the second half of this year, both from a clinical standpoint, but also what the high-dose formulation might mean in the context of your IP?

Well, maybe I'll start by just saying what the hope here is, is obviously, for years now, EYLEA has stood out as unique in terms of delivering a certain degree of efficacy and safety is the standard bearer in the field. And it's already being used, and initially it was used to extend treatment duration and so forth. What we're hoping to do is to now see with the higher dose EYLEA that we can maintain that incredible safety profile, but now extend treatment duration for the average patient even further. So now patients will be able to be treated less frequently. So that's the design of the trials to test that. And we think, and especially based on the Phase II data, that we have a reasonable chance of now showing that the high-dose EYLEA will deliver similar safety -- exquisite safety profile, while allowing patients to have longer interval of treatment, which will provide, we think, a significant advance for these patients. In terms of the commercial perspective, maybe I'll turn it over to Len and Marion.

Yes. I'm not sure if there's anything more to add because Regeneron commercial is going to follow the science and product profile. And I think it's pretty obvious what it could do, Cory, if -- as George says, if the product profile is as we hope it will be. Maybe we should just move on to the questions.

Yes. And there's a couple of questions in here. I'm just going to combine into one. It might be appropriate for Marion to respond to some of these. Can you discuss your longer-term outlook and expectations for EYLEA? And along those lines, do any of the new entrants pose a particular threat to the program? And they list out things like Lucentis, biosimilars, faricimab, Kodiak, etc.

Sure. So let me -- yes, I'm happy to comment. We don't give future guidance, but I'm very happy to talk about the market and some of the expectations we have. The first I'd add is just we really did see such strength of performance in EYLEA over the last several years. But certainly, as Len gave in the data today, the fourth quarter of this past year and the year-over-year results, we are in a highly competitive market today with low-cost alternative and branded competition. And I'm pleased to confirm the market share we've seen branded at about 75% of the category and about half the overall category in terms of EYLEA performance in the anti-VEGF category. Certainly, strength of performance and appreciation of our breadth of indications, ability to treat and extend patients, the remarkable safety. And for any products coming into the marketplace, this is going to be a very tall order to even be potentially competitive with EYLEA. And of course, the world did forever change as prior competition ran into real-world situations related to safety. So all that said, we're very excited about the coming year with EYLEA. Our competitive readiness is always very, very strong. We take nothing for granted, but we have really a world-class team in the market with our medical affairs and also commercial colleagues. And I feel we're very strongly positioned, not only for EYLEA in the coming years, but also the aflibercept 8-milligram product potentially in our future.

Okay. Terrific. Moving on to the pipeline, and for either George or Len. Curious, what are the key factors you're looking to see in those initial clinical updates we'll get for your CD28 costims? And working a portal question in as well, how do these programs, the CD28s, fit into your overall strategy to expand Libtayo?

George can comment on that since he's designed this entire program and strategy with his team. But I would just say that looking back, we've -- what we've already accomplished, I think, is some -- showing that we can get up to doses where safety might have been a concern, and we haven't seen any of the kinds of scary, safety things that this class of agents was originally associated with. But as to what we hope to see, George?

Well, first of all, just to remind everybody, we designed and brought into the clinic, some of the first CD3 bispecific antibodies. And we're now reporting some of the very exciting efficacy results with these. And as Len said, we then developed as a second-generation bispecific -- costimulatory bispecifics. And what we hope for this was, first of all, that they would avoid the safety concerns of these targets that had originally been tried years ago that had severe safety concerns, but could also allow them with significant safety to then be combined with either of these original CD3 bispecifics or with Libtayo, our foundational PD-1. And our plans are going according to our designs now. Our CD3s have all delivered impressive efficacy. And I just told you that even some of our early data in our solid tumor programs with our bispecifics are now delivering efficacy. What we're hoping to do is now add or extend to that efficacy by giving our costim. So for example, in our MUC16 program in ovarian cancer, as I just mentioned, we are seeing activity with our CD3. Can we enhance that activity by either combining it with the CD28 bispecific in a safe manner or with our PD-1? I think these are very, very exciting opportunities because these can really change the field, change the practice of medicine. We're not just talking about putting a CD3 out there. We're talking about a CD3 and then extending its efficacy with either a PD-1 or with a costim in many of these tumors that we're talking about, whether it's ovarian or prostate cancer. Just seeing any enhancement because these have been very immunotherapy-resistant types of tumors. If we can extend that efficacy, we can really change the practice of medicine. Similarly for our lymphoma and myeloma programs, where we already have what we believe is a potential best-in-class efficacy with our CD3 bispecifics, if we can just extend that just minimally with our costim bispecifics that we're adding in those programs, we can really separate the treatments and once again, change the practice medicine to a whole another level. Remember, these bispecifics, on their own, seemingly are working on par with CAR-Ts. What if you could now extend that therapy, okay, and get even more efficacy, even just a little bit more efficacy safely by combining with costim. So we are in very exciting times. Things are core -- going according to plan. Our foundational PD-1 molecule is there and delivering its efficacy. Our CD3 bispecifics are there. They're delivering their efficacy. And now, hopefully, over the next year, we'll be announcing some of the data with our costim bispecifics. And if they can further extend what we're seeing already with our first-generation bispecs and with PD-1, I really think that we can be changing the practice of medicine and really delivering important new benefits to the so many, so many underserved cancer patients that are out there today.

Great. We're down to 1 minute left. I want to work in this one question in the portal that asks about the progress you're making with allergy programs against birch, peanut and cat allergies. Can you summarize super quick how those are going?

Well, once again, those are also first-in-class programs that we're very excited about. We've designed -- the reason you get allergies as your body makes the bad IgE, E for evil antibodies, against all these allergens. We are simply making IgG versions of these antibodies that essentially block the evil IgE antibodies and prevent allergies. Our Phase II data in these programs are really extraordinary. They really are shutting down allergy. And I think that the only challenge is that there are rather complicated Phase III programs that need to be designed in the real-world setting in patients that have multiple allergies, where it may be challenging to show the effects on individual allergies. But the Phase II studies that are studying specifically allergen-induced responses in these patients have been exquisitely blocked and attacked by our anti-allergen IgG antibodies in both the cat and the bird setting. So we think these are very exciting programs. They are somewhat challenging to design in the real-world setting in patients with multi-allergies, the Phase III programs.

All right. Terrific. Well, unfortunately, we're out of time. A lot more questions for you guys. We'll get to those and some other points. So Len, George, rest of the team, thank you very much for participating today. We really appreciate it, and good luck the rest of the week.

Thank you, Cory. We appreciate it.

Thanks, Cory.