ImmunityBio, Inc. (IBRX) Earnings Call Transcript & Summary

Good morning, everyone, and welcome to the last day of the 2026 J.P. Morgan Healthcare Conference. My name is Ben Davis. I'm an associate with the Healthcare Investment Banking team at JPMorgan. And I'm pleased to introduce Richard Adcock, CEO; and David Sachs, CFO of ImmunityBio. Richard will be running through his presentation, after which we'll have some time for questions and answers.

Thank you. Thanks for everybody being here, and thanks, [ Benjamin ] and JPMorgan team for inviting us. Today, what I really want to do is talk to you about what did we do in 2025, setting us up for 2026. I think the most important thing to note is that we had an absolutely incredible 2025. And if you've been following the press releases that we've been issuing this week, really spotlight a number of pieces, and I'll be talking about those in more detail. Everyone here is familiar with forward-looking statements. So in 2025, and I'm not going to read every word on the slide here, we really are going to provide you an update on what do we do in bladder, what are we doing in lung, lymphopenia and then other solid tumors like pancreatic and you'll see some others as well on these. In bladder cancer, obviously, as everyone knows, we got our approval in 2024. But right out of the gate, we said that we're going to need the reimbursement code. So January of this year was when we received our J-Code, and that's really when the commercial team really was able to start in full force on those. What I'm happy to report is today, we announced a 700% revenue growth year-over-year. It was 400% quarter-over-quarter from those from '24 to '25. Beyond that, we received our on-label NCCN guidelines. We received both U.K. MHRA approval, and then we received the EMA recommendation at the end of the year for our marketing authorization, and we expect the European Commission to receive that in early February or February on those. Beyond that, we're working on additional key rest of the world regulatory preparations for each one of those, and we'll talk more about that later. On the papillary only, we had submitted and are up for review, and it's actually been reviewed and expected to read out by the NCCN first quarter of 2026 on those. Again, that's one of those that our data is stronger than everything else has already been done. So we have every reason to believe that we should be receiving that in Q1 likely. But beyond that, we -- as many know, we submitted a supplemental BLA at the FDA's urging. They issued a refuse to file like they've done with many folks. But what I want you to know is that we're still having ongoing conversations with the FDA about this, and this is a piece that is not yet done as we continue to have productive actions with the FDA on that. And then on BCG naive, we'll go through this in great detail. We're near full enrollment, and we anticipate having that fully enrolled in the first half of the year. So as a reminder, if you take a look at ANKTIVA in the use for non-muscle invasive bladder cancer, specifically in the BCG unresponsive market, ANKTIVA has 53 months in ongoing duration, way more than anybody else that exists out in the marketplace. And this is one of the things that sets us apart, and there are many pieces on here. As we have worked to deliver this around the world, and we worked with EMA and MHRA and the Saudi FDA, it's that duration is one of the things that continually point to and say this is absolutely a breakthrough that no one else has. Some of the other highlights is 84% of the patients who responded to ANKTIVA were able to keep their bladder up to 3 years. That is what the holy grail is. If you get bladder cancer, obviously, you don't want it to take your life, but you also don't want it to take your quality of life. And that's where ANKTIVA sets itself apart from everybody else again. 71% of the study participants had a complete response, meaning their cancer was eliminated. This is in the full N of 100 that was fully reviewed by EMA on those. And again, as I had said, 53 months of duration or over 4 years, and it's ongoing. And so it won't be that long. We hope you will see it's even over 5 years. There's a 99% disease-specific overall survival at 36 months, 99% disease-specific survival. Again, each one of these numbers, you compare them to anybody who's out there currently or coming on the market are very much stronger. Setting up for commercial success, we've had a very, very strong year. The market access team, as we've reported in the past, has hundreds of millions of lives that are all of the major U.S. plans. Knock on wood, again, is always on those. We have not had any reimbursement issues with anybody. All of the sites are getting great reimbursement. We have a full concierge program that we can help sites as they get going on those. It's our ImmunityBio CARE's program. Our NCCN guidelines were issued for on-label in May of 2024. But then the big one, which we told everybody last year at JPMorgan was really the announcement of the J-code is what's really going to open up the sales year, and you can see by the incredible growth this year, that's exactly what it is. Last year, we also reported that we'd be working on EMA and MHRA approvals, and then Saudi Arabia is the most recent approval, which we're very proud of for bladder cancer. So you can see ImmunityBio has taken a very concentrated effort to not just get a U.S. approval and commercialize it, but also truly make this drug globally available. Just another way of looking at the incredible sales performance that has happened here with a 700% product net revenue increase. Again, as it was reported by others, a 400% quarter 4 over quarter 4 [ on site ] of those an 84% change as well, which shows you real consistent growth quarter-over-quarter, which is really what you want to see. Another way of looking at this on a unit basis, a 750% increase from year-over-year or an 87% on monthly consistent adoption. And what's happening, we're seeing this as new sites sign up, they almost inevitably always say, here's our toughest patient. Let's see how this one does. And when they go into a response and then more and more patients show up. And remember, this is 36 doses over 37 months. And so once they start, they're with us for a long time because they're having great success with it. On a cash basis, we reported this morning in addition to the $113 million of sales that we had $243 million of Q4 opposed to the $257 million that we had in Q3 of just this year. So very strong or the end of last year, very strong cash position on those. And as you see sales grow quarter-over-quarter, you see the lessened need on all of those. So that's really kind of the quick summary as we take a look at those pieces. I now want to talk to you about our BCG naive. That was our unresponsive -- in the naive setting, and this is one we've issued press releases on just most recently as a reminder, in the process of getting our BCG unresponsive trial, the FDA asked us to unblind and take a look at those first cohorts. In the original one, before we even jump to those, there was 9 of 9 patients to start this at the Phase I that had a complete response. Prior to us getting our approval, they said, please go tell us where those 9 patients are. As we went and did that, we found out that 2 had passed the disease other than bladder cancer because 73 is the median age. 9 years later, that happens. One was not followed up because no one was supposed to be followed up, but we were able to identify 6 of 6. All 6 were still in complete response. They had no follow-on treatments. And most importantly, they all had their bladders. That was 8.5 years. Now it's 9.5 years out on those. The conclusion here is really important is that ANKTIVA plus BCG in the BCG-naive setting gives patients both a durable and complete response. And that's one of the pieces that you just don't see about this. When you start getting 9.5 years out on those, it really changes the way everybody looks at this. But as I indicated, we were also asked to take a look at the randomized controlled trial by the FDA. And obviously, when they ask you that you do that. And in that interim analysis, what it showed is that the BCG alone arm was 52%. The BCG plus ANKTIVA arm was 84%. And what's important, it was statistically significant at very much that small number. Now if everybody knew that you'd make a much smaller trial because you'd already have won that one. But today, what I'm here to tell you and what we've announced at this conference is that we're 85% already enrolled in that. We had previously indicated we thought we'd finish that out in the first half of 2026. We're ahead of schedule. We're still with that same time line, but it will likely even be faster than that. So we have ongoing recruitment. In 2025, we moved it really from a U.S.-only trial to U.S., India, Europe, South Africa and many others. And so that's, again, in that wave of ImmunityBio truly being a global company. That's what we set out to do inside of those pieces. Expanding that trial clinically internationally also accelerated that. And so now we have a much, much bigger piece. And again, we're here today with an 85% enrollment. So in early '26, you'll see a readout of that. That trial design is that after the last patient has enrolled, 6 months, and you can go ahead and submit that, and we anticipate it being an sBLA with the FDA. Obviously, they're not surprised by this because they're the ones who asked us to submit this data. And so we've been in contact with them, and we'll be very actively submitting that. Okay. Staying in the bladder, but now moving on to the recombinant BCG. So as announced when we received approval, ImmunityBio and Serum Institute entered into a global exclusive for their recombinant BCG. And this year, we were proud to announce that we had opened up an expanded access program for that. And what I can tell you is there have been literally hundreds, hundreds of patients, many hundreds of patients in sites with thousands of doses, all very successfully delivered on to those pieces. The recombinant BCG, amongst many pieces, one of the things that it has is the ability to manufacture at scale. So instead, as many people know, BCG is manufactured in all roller bottles, 40-, 50-year-old technology, and you have a lot of variability to those. What the Serum Institute did in collaborating with us was the ability to produce this in large stainless steel tanks, and so we can quite literally make unlimited supplies. And instead of it taking months to produce, it takes weeks. So it's a faster production at a higher quality and more consistency. So this is really our pipeline we're looking forward to on all of these pieces. And what I would tell everybody to focus in on is what we're doing on the unresponsive globally, but really that BCG naive trial. That BCG-naive trial instead of really saying, well, let's do intermediate, let's do this, let's just go right to the very beginning of this. And that's the approach that we're taking. We believe from everything that we know that we're the furthest, most advanced in that. And the beautiful thing sitting here today, we all already know what the outcome is because the FDA required us to be able to provide that to them, which we obviously provided to the entire world. I think it's important to always talk about what you're doing, but what I really want to do now is let one of our patients talk about what this means to them. [Presentation]

So Dr. Soon-Shiong, our Founder, our Executive Chairman, Global Chief Scientific Medical Officer, always reminds us stay focused on the [ why, ] those patients are [ why, ] many of those patients were the patients that were in the original Phase I trial that really delivered on the ultimate results that we're seeing today. And it's really, really important to always stay focused on those. Now as you all know, ANKTIVA and ImmunityBio is not a bladder-only company. We love uro-oncology. We're incredibly excited and very focused on it. But ANKTIVA quite literally works across every tumor type. It works in infectious diseases from HIV and others. What I want to now talk to you about is lung cancer. So I'm going to actually take you back just a minute. At ASCO 2024, it was a very important headline. I remember grabbing the ASCO paper that day. And basically, it says, what are we going to do? Checkpoints are failing, specifically in lung cancer, and there's nothing on the horizon. And nothing else has yet come up through those beyond ANKTIVA. Non-small cell lung cancer standard of care, 2 very large trials, the REVEAL trial as well as the PRAGMATICA trial, both showed standard of care about 9 months. Nothing has moved off of that mark. We were recently this year at the World Lung Conference, and we had a group of clinicians with us and they said, we believe and we know based on the data you're showing to us that ANKTIVA plus checkpoint is what will truly move that needle forward on those. Let me give you a little more information on it. And you've heard likely Dr. Soon-Shiong talk about lymphocytes. Lymphocytes matter. There are many papers, whether it's from Mayo Clinic, whether it's from Johns Hopkins, MSK, MD Anderson, all talking about that your lymphocyte count is a prognostic indicator as to how well you will do in treatment of your cancer. If you look at this one here, and first of all, look at the p-value in the center, p-value of 0.0065, highly statistically significant data. This is new breaking data here at this conference. QUILT-2.023 was a randomized controlled trial in first-line non-small cell lung cancer, ANKTIVA plus checkpoint versus checkpoint alone. In the experimental arm, you can see the blue line running along there, they both started. The experimental arm and the control arms both started where they were effectively the same, not statistically significant. But as you move through the blue line separation from the red line, looking at the ALC in those, you see a very clear separation and again, statistically significant on those. This data is truly what is very important, and some of you have already heard about the announcements that we've made. Following on with our next trial, QUILT-3.055, this was a single-arm trial, which was about the restoration and the maintenance of ALC and that correlated with the prolonged overall survival in second line. So the last one was in frontline. Now we're looking at second line. If you look at the ALC nonresponders versus the ALC responders, here you see a median of 11.5 months, which is still better than the about 9 months you were seeing with standard of care. But on the ALC responders, you're seeing 21 months. And again, a p-value of 0.0009, highly statistically significant and really quite impactful because if you know standard of care is running at 9 months, and here, you're now looking at pieces that are 21 months out, it's really a very powerful piece. On the strength of all of this, we've met with the FDA. We've met with others. We opened our ResQ201A trial, which is enrolling. But more importantly, and we announced that at this JPMorgan, the Saudi Arabia FDA not only reviewed our bladder, they reviewed lung. They reviewed the 2.023 trial as well as the 3.055, so our frontline and second line. And on the basis of that, they granted accelerated approval for ANKTIVA plus checkpoints in metastatic non-small cell lung cancer. Now this is truly a historic moment for ImmunityBio because it truly is the demonstration of what Dr. Soon-Shiong and the entire team, medical and scientific team have said, which is ANKTIVA works across all tumor types. And so now we're approved in both our intravesical delivery as well as our subcutaneous delivery on those. And so this was broken yesterday, I believe it was, as with everybody, JPMorgan is one series of long days on those, but again instead of me telling about it, I want to tell you about one of our patients that was in QUILT-2.023. [Presentation]

[ Valorie ] story was actually just recorded last week. Once we got the Saudi Arabia approval, we wanted to make sure that we had something that was not something that had been sitting around, but it was truly relevant for this audience. And if you remember her story, what she said is the doctor gave me 6 to 8 weeks. She's 43 months out at a high quality of life because you heard her talk about I couldn't take the chemo. Standard of care was just too much for me. Maybe it was going to work, maybe it wasn't going to work for me. But my quality of life, I couldn't spend time with my granddaughter. 43 months in a high quality of life. That's the difference that ANKTIVA brings to this piece. And that, honestly, and I want to extend my gratitude to the Saudi Arabian FDA. They were amazing to work with. They truly reviewed every piece of our bladder, asked absolutely the right questions and then rapidly looked at the lung data and said, this is truly groundbreaking data. And on the basis of that, we're going to offer you an accelerated approval on that one. This is truly what I told the team, this is the beginning of the beginning. And as we're starting this here now, it's going to really start to unlock and unleash other ones because we've already had other global health regulatory authorities since we've been here, reach out and say, let's talk about this. What else can we do with this? Now the next ones that I'm going to go on are more used with ANKTIVA but this round of them is ANKTIVA plus our cellular therapies. So the first one was ANKTIVA plus BCG. The next one was ANKTIVA plus checkpoints. Now we're getting into ANKTIVA plus our CAR-NK cells. So a little bit of update on lymphopenic because we've been talking about lymphopenia and all of those. If you go to any scientific conference, whether it's ASCO, whether it's a GU conference, whether it was just published, what we published in the American Journal of Urology, everybody is now waking up and saying, well, it's really all about lymphocytes. And up until now, there really hasn't been anything we can do. On the basis of that, last year, we were very proud to announce that the FDA had worked with ImmunityBio to open an expanded access program. I had to look it up once we received this because it's actually the broadest expanded access they've ever opened on an issue which tells you they're highly confident about the safety profile of this, but they're also equally confident about the efficacy profile. And so as we step through these standard of care destroys your -- the very cells that kill cancer. If you've ever listened to Dr. Soon-Shiong, our Founder and Global Chief Scientific Medical Officer, he talks about a 400 million-year-old cell inside of all of us the natural killer cell, the only cell that is designed to kill cancer. your T cells and your natural killer cells. When you get chemo, when you get steroids, when you get checkpoints, all of those are destroying the cells that you need to actually kill cancer. But that's been the standard of care for the last 4 or 5 decades. Now with ANKTIVA, we actually have one that reverses that. Lymphopenia and low ALC clearly and unarguably result in reduced overall survival. So just as Epogen is used across all tumor types for low red blood cell count and Neupogen is used for your low neutrophil. Well, up until now, with lymphopenia, there's been nothing for almost 50 years and not been able to do those. But with the approval of ANKTIVA in bladder, if you look at Section 12.1 of the actual label itself on the package insert, what it says that ANKTIVA activates and proliferates natural killer cells, CD8 killer T cells, helper T cells, memory T cells without the Treg. So when CEO speak, I always say you get the good guys without the bad guys in those. It's those memory T cells that you get to see [ Valorie ] story. So those memory T cells, you got to see the other ones. It's, first of all, bringing it back so you can fight the battle, but then have that prolonged high quality of life. That's one of the big differences. And it was on this that really the FDA gave us that. Now what I want to talk to you about is our GBM program. We've issued some press releases on this. Again, more exciting data. Our QUILT-3.078-GBM is an open-label Phase II where we're using ANKTIVA or N-803 as well as our CAR-NK, specifically the PD-L1 version of those, along with standard of care. If you look at these trials, and I'm actually going to jump to the next slide because I think it's the most impactful. The image on the left, you can clearly see the tumor. That's March 3 of this year. They had an ALC of 500. Just a few months forward, October 15, you can see the tumor is largely gone. Just plain naked eye, you can see that. But also notice what happened to the ALC. It went from 500 to 1,100, and it's increasing. That's the power of activating and proliferating your own body's natural killer cells as well as T cells so that your body can actually do that. Now we did this in combination with our CAR-NK, specifically the PD-L1. Here's another version, another patient of this, May 14, 2025, where they had an ALC of 1,100, which is technically not lymphopenic, although they're still struggling to fight it. September 14 -- September 4, excuse me, 2025. It increased during treatment. And that's what's really important is usually, if you plot them all, every treatment you do decreases your ALC while you're actually fighting to do those. So now when you're getting the results, you're actually increasing your immune system. This is the entire new paradigm shift that you're going to see, and we believe will ultimately change the overall course of care. Not to be outdone with that, NHL, again, will be ANKTIVA plus now our CD19 CAR-NK. This is an open-label Phase I exploratory trial where we're enrolling up to 20 subjects of those that are randomized between different cohorts of those. What I can tell you is the initial ones after just 2 rounds of treatment, we're already showing complete responses. While this is still an ongoing trial, we've actually submitted a larger trial to the FDA to continue on both our GBM as well as our NHL. Each one of these are demonstrating and delivering on the exact proof principle that Dr. Patrick Soon-Shiong set out originally. If we want to bring long-term durable responses, you've got to be able to protect the immune system. You've got to be able to bolster the immune system, but then you've got to bring the killers along with it. And so each one of these I've shown you is a very common, and it happens to work across, quite literally, we've done in almost every tumor type now. And so as you take a look, I'll finish clinically on these pieces here in pancreatic. Most importantly, again, last year, we had a very big year. The FDA gave us an RMAT authorization for our use of our PD-L1 t-haNK and ANKTIVA in third-line metastatic pancreatic cancer. So you can see there's been a lot of global growth that has happened on all these pieces as well as a sustained overall contribution. In this trial, what we saw -- and unfortunately, QUILT-88 is metastatic pancreatic cancer. Everybody knows that is the cancer you don't want to get. It's certainly one of them. GBM is not another one that you want to get with those, and you're seeing these strong results. In QUILT-88, we had all subjects or an N of 50 had an overall of 5.3 months. But if you looked at the responders versus the nonresponders, those who had an ALC response had a 7-month duration on those. But look at the p-value, 0.0001 with a hazard ratio of 0.28. You can see a very common theme across all of these over and over again. And in conclusion, if you look at this, what we talked about is we had -- and I just want to, first of all, say thank you to the entire ImmunityBio team. I guarantee you, everybody that worked for the company worked incredibly hard. I want to thank Dr. Patrick Soon-Shiong. It's his vision, but it's his daily execution that is driving these results. This absolute attention to what are we doing in bladder, where you see a 700% growth in revenue. You see global health regulatory agencies giving us this. You see commercial success now and the Street had us with an expectation of about $100 million, and we announced today that we did $113 million. So strong performance by everybody on those. But the one I really want to focus everybody's attention on for 2026 in bladder is the naive trial. We're running ahead of schedule. That trial, since we already know the preliminary results on that one will be one of those things that we think will differentiate ImmunityBio in the years to come. In lung, Saudi Arabia being the first in the world to be able to offer that demonstrates that ImmunityBio is, one, doing amazing things in bladder, but now outside of bladder as well, what you saw in lymphopenia and then in other solid tumors. And with that, I would actually open up for questions.

So just to open up the Q&A, I was wondering if you could expand a bit on the ANKTIVA launch and the commercial performance so far and what you've seen as some of the key drivers?

Yes. So interestingly enough, when we launched specifically in 2024, one of our competitors, they had a very rough launch in sites and it literally, I couldn't tell if it was [indiscernible] would tell us how we lost not with our product, with somebody else product, $0.5 million. I lost $0.25 million because the market access wasn't in order. And it's really important. That's why I say I'm incredibly proud of our market access team and really the entire ImmunityBio CARE's team that does all of that, that offers that white glove. To date, I'm not aware of anybody who's not received full reimbursement. I think that's what separates those. Obviously, everybody knows in these drugs, they're high-cost drugs, but they have amazing results on those. But it's not just the science of getting the drug done. It's the ability to focus down to the smallest insurance company to that individual patient and get -- make sure they have that. That's what's ultimately delivering the results that we're seeing and why we're seeing strong results quarter-over-quarter-over-quarter. I'll tell you what's been fascinating for me is watching new sites come online because we're seeing many new sites come online. And inevitably, each of them always start with saying, here's our toughest patient, show us what you got. And when we get a response in that one, it literally just kind of opens up the floodgates and they say, here's a second, a third, a fourth because it's important to remember, this drug is actually administered in most instances by the nurse. And so while the doctor is clearly doing all of the care on those, BCG for the last 4 decades has largely been administered by MAs, nurses and nurse practitioners. We're just admixing ANKTIVA with it. And so it's the same treatment path. We're not asking to buy any new refrigerators, no new freezers, and it's the same course of care. So the doctor has been able to take care of a patient over here while the nurse is taking care of this one. That's incredibly well received by them.

With lymphopenia expected to significantly increase your market size, I was just wondering what steps you're taking to make sure you've got enough supply and maybe also an update on the internal manufacturing that you have?

Yes. So one of the things that's obviously unique about ImmunityBio's Dr. Soon-Shiong and I say this over and over again, he is steeped in manufacturing. And so as he's very, very famous for saying, you can't just have a process, you must have a product, which means you have to have it down to the assay level of everything you know so that we don't have those. I can tell you, and it's something I personally pay quite close attention to, we have ample supply to be able to supply the in total global supply chain. I personally am meeting with everybody that's involved in those. But it's not just the production of the drug substance, the drug product, the finish fill, it's the ability to be able to deliver it to the patient. In the United States, we've set up a system where I had one doctor tell me this is like you Amazon drug delivery. I order it, the next day it shows up because it doesn't even come from the middleman, it just comes directly to our door. And so I can order 1 vial if I want or 6 vials or however many I want. And so it's a really important question because if you don't have the ability to do the supply chain and that you've seen that time and time again, new drugs get approved and then it's months and months and months and then they have limited supply. I'm proud to say that the ImmunityBio team has not had any of that, and we watch that truly like a hawk. Next question?

So you had discussed the wide range of indications that you're currently pursuing. And we got to see a little bit of physician testimony in the video. So I was wondering if you could expand on what the clinical feedback has been so far?

Yes. That's -- honestly, it's one of the pleasures of my job, and I'm very much -- don't sit behind the desk CEO. I love to get out and meet with folks. I have doctor visits set up actually for next week. And one of the things that's important is the doctors always glow about it. But specifically, when you're in bladder, and I've been in this career now for 3-plus decades, I always make time to go find the nurse, not just because they're the ones who run the doctor's life, but in this case, they are ones who actually deliver it. And so when we meet, whether it's large groups of doctors or other ones, I always ask them to include the nurses specifically the BCG nurses. And what over and over again, they tell us, whether it's in the biggest, highest named institution or the smallest one, which is just ma and pa and one nurse that are doing -- running there, they say the same thing, the patients love this. They're always telling me, you got to talk about how you make BCG easier to stomach and I say, we can't say that. You can say it. We can't say that because that wasn't one of our clinical trial endpoints, but we know that. And ANKTIVA is actually helping the immune system to be able to handle this. And so it is one of my privileges is to be able to go those and I make sure we do those patients, you hear from their story, you hear from doctors. The one that we did, I'll share this piece, we had our national sales meeting. And one of the things we did, we brought our entire commercial team together and congratulate on the year they're having and set them up for an even much bigger year next year, and we brought a doctor, a patient and the nurse. And it was fun because the doctor was actually explaining this and that and the nurse sit there for a while and she said, well, actually, doctor, let me tell you -- you're close, but let me tell you the rest of the story because they are the ones that do that. And so ANKTIVA is one of those that you see, whether it's in lung, whether it's in the GBM patients or whether it's in bladder that really just gets everybody in the clinical care team very excited.

Can you expand on your discussions with NCCN regarding guideline expansion to include papillary-only disease? And how critical would this be for physician adoption?

Yes. Probably, I'll tell you, we had an ad board most recently. And in that one, the #1 question they asked was, why don't you get your NCCN guidelines? Because we don't clinically treat papillary only or cyst only, we treat BCG unresponsive bladder cancer. And right now, because of insurance and because of the way the FDA has set this up, we have to. And so they're all anxiously waiting on it. What I can tell you is that the NCCN guidelines and papillary only, the market size is 3 to 4x larger. And so back to the original very important question that was asked back there about supply chain, we're fully ready with supply chain. If you look at the 2 that they've approved, we're not asking for anything different. And in every measure of every part of it, our data is stronger. So I can't think of any foreseeable reason that they wouldn't do that. Obviously, I'm not putting pressure on the NCCN, respect their process. What they've told us is that in August, they'll review it, and it's typically a 6-month review, which would be this February. So we're very eager. We're anxious to be able to see that. But it is very important because not just from a sales or revenue perspective, from the practice of medicine. And that's what doctors are expressing to us. We need this so that we can just practice medicine the way we practice medicine.

Thank you. I think that's all the time that we have. So thank you very much.

Thank you all. I really appreciate it.