Apellis Pharmaceuticals, Inc. (APLS) Earnings Call Transcript & Summary

All right. Tell us, best company in Massachusetts, and by that, you mean the United States. So Cedric Francois, CEO; Tim Sullivan, CFO. Welcome. So for those in the room, there's a mic runner if you have questions, and I can relay to management. So again, I'm Yigal Nochomovitz covering Apellis since, well, a long time. Since the -- before the IPO, since we were private, since I went to visit in Louisville in 2014 or something like that. I forgot when.

Not many have, Yigal, not many analysts have.

Yes. Well, yes, that was a good meeting with Pascal and the old guard, I guess.

Okay. So let's start with the new indication, which -- well, it's not so new for you, but for -- maybe for investors that need to understand it better in kidney disease, C3G, IC-MPGN, you had some very nice data, Phase III data recently a few months ago. Tell us about it, tell us about how you believe it could impact patients. And I'm sure we'll have plenty of detailed questions soon?

Okay. Thank you so much, Yigal. Well, first of all, thank you for inviting us to this conference. It's wonderful to be here. So yes, the data in C3G and IC-MPGN in the so-called Valiant study was a study run in 124 subjects, where we -- I'd say like it's a little bit of a tradition of ours to go very broad in these populations and afterwards find out where the real defects lie. And so we enrolled in this study adolescent adults, C3G patients, IC-MPGN patients, pretransplant, post-transplant, C3 depleted patients, C3 competent patients. And across the board in all of these phenotypes saw the same kind of remarkable efficacy profile that Empaveli and the ingredient pegcetacoplan has shown time and again across so many indications now. Results far outweighed what we had even expected from this trial. And to make a long story short, I mean, across the 3 parameters, which are proteinuria, eGFR stabilization and then also, and very importantly, the deposition of C3C, which you can find on histopathology in these kidneys, seeing that disappear completely in about 70% of patients after 6 months when these kidneys in these patients basically look normal, that was really incredibly gratifying to see. That means that if you're an adolescent or a young adult with this disease and normally having to face a kind of an unstoppable progression towards the end-stage renal disease, hemodialysis and maybe transplantation, the efficacy profile of this drug seems to indicate that you may never need those interventions in the future. Another element that is worth pointing out is that the need for concomitant medications may be drastically reduced to something that we see in Valiant, we will be talking about more. That is, of course, very important. These are strong immunosuppressants, including steroids that have side effects for these patients. We're going to find out if that is even still needed. But for now, we are incredibly happy with the data that we found.

So I think it would be helpful if you could just -- I think there's still some not confusion, but just help us understand the difference between C3G and IC-MPGN. I mean are they distinct, are they related? And the point being is that your -- you've studied both of those populations. The competitor -- the oral competitors not generated data yet in IC-MPGN as far as I understand and it may not be for a few years. So maybe just help us understand that a little bit better?

Thank you, Yigal, and that is a very important point, right? So I mean, the main difference between C3G, IC-MPGN, which are believed to be kind of twin indications look very similar phenotypically, in terms of manifestation, histopathologically as well. The main difference is that in the deposits that you see in the kidney in IC-MPGN, you have immune complexes, right? So when you stain them for antibodies, they will show up positively, where as in C3 glomerulopathy, you will find complements, but not associated with antibodies. So there may be or there is believed to be a classical pathway components to IC-MPGN that may not be there so much in C3G. But certainly, there is overlap between these conditions. Now in terms of what this means in incidence or prevalence in the overall population, we believe that in the United States, there are 5,000 patients between these 2 conditions. The way in which we came up with this number because it's still unclear really where the prevalence sits. Other companies have come up with much higher numbers. There are some ideas that there may be lower numbers. We went back 5 years in the past. And a patient identified as having 1 of these 2 conditions was a patient that in the past 5 years, had at least 2 diagnostic codes. That's a pretty high bar, right? I mean so we believe that, that number of 5,000 is quite conservative. That is split more or less 50-50 between C3G and IC-MPGN, and 20% of those 5,000 patients, so approximately 1,000 patients are transplanted. So those are kind of the gross numbers, but importantly, in our trial, we took a little bit of a chance, right? I mean by including IC-MPGN, where we enrolled fewer IC-MPGN patients than C3G patients, but saw the same effects across again both phenotypes in this trial.

So since you've covered all year basis in terms of both of the phenotypes and then the pre- and the post-transplant and in terms of pediatrics and adults. So, you have covered everything. And the competitive molecule is oral. So there's some discussion around oral versus subcu, but there's not a parallel there in terms of what's been explored in the clinical setting?

Yes. So our competitor chose a different approach. They only study C3G. They only studied adults, not adolescents. They only studied pre-transplant, not post-transplant, and they only studied C3 depleted patients. So if you kind of narrow that down, that's a small number of those 5,000 patients in total. Of course, we're going to have to see how the label ends up. I mean that may not be exclusionary. I mean we'll have to find out, but having the data in hand is, of course, very powerful. And I think when we see how it was received at the American Society for Nephrology in October, it was, I mean, incredibly grading.

And so just really quickly, just remind everybody when you're filing that's, I guess, an sNDA or how would you characterize it?

Correct. Yes. supplemental NDA because Empaveli is already approved for PNH. We are on track to file early in the year as we had promised. And then depending if it's priority review, it would be 6-month review. If it's not priority review, it would be a 10-month review cycle. So I would say like the longest case would be that we would be ready to commercialize around this time next year.

Okay. And you have teams in place that you're working on building out that commercial effort?

Yes, absolutely. So Maybe, Tim, do you want to speak a little bit more to that?

Yes. So basically, we've already hired the senior management from the commercial perspective. We are leveraging some of our existing PNH infrastructure because it's the same drug. It's the same manufacturing. It's also the same more or less distribution. So we do plan to build out a sales force of somewhere between 40 and 50, which is approximately what we -- but we think we will need -- our competitor has 100 reps. We believe, and that's targeting a broader population. So that's all nephrologists. We have a much more narrow one that would focus on this population. So we think we're pretty well covered. Probably about 4,000 nephrologists we're aiming to target.

I mean, we've talked to a number of KOLs, as you know. And they obviously highlighted the very, very strong efficacy. And I think some of your experts obviously have noted that having the efficacy should be the determining factor over maybe slightly better conveniences with oral. I guess I've kind of summarized it, but anything else you want to add to that statement?

No, I think that's the key, right? I mean it is -- I would say that our competitor, we have not seen the data on C3C deposition. That's really important. I think it's something that we need to take a look at because it's an important differentiator, beyond, of course, the differentiation in proteinuria and also on eGFR, but also kind of the need for concomitant medications. I mean that's something else that you want to take as few medications as possible. So I think the story in C3G, IC-MPGN has just started to get written. In IC-MPGN, we will for sure be the first one. The C3G, we will not be far behind our competitor. And again, I think in the post transplant segment, especially in the pediatric population, we will have like a pretty unique position. And also important to point out is that in development behind us, there is very little, right? So that's something else where for several years, I think we will become a mainstay for these patients.

And like in some other areas in development with your pipeline, you've done long-term extension studies. Do you have such a plan for C3G, IC-MPGN to continue to monitor or like to see longitudinal benefits on eGFR beyond the primary endpoint?

Yes. So we have, again, a long tradition of taking care of our patients beyond the clinical trial. So after Valiant, we have the VALE extension study where patients can -- well, are continued to be monitored. And then at the right time, of course, if my commercial product is available, it can be switched over.

Okay. And then what are the plans outside of the United States to develop this indication?

So we have our partner, Sobi, which has the rights to Empaveli outside of the U.S. where it's marketed under the name Aspaveli.

So they have the rights to the glomerulopathy, okay.

They do. Yes. You should absolutely speak with Guido because his enthusiasm is infectious.

Okay. And what about other territories, they have everything outside the United States?

Everything...

Outside Asia as well?

Correct.

Okay. Okay. Great. And as far as other conference presentations, I mean, you've given a lot already, but what's the -- is there another data point that we should be looking for outside of the typical regulatory?

You mean specifically in C3G and IC-MPGN?

Yes, just in terms of other clinical -- I mean, I know, for example, I mean in ophthalmology, you have many studies that beyond the -- go beyond the primary data?

Yes. So we -- look, in C3G and IC-MPGN, I mean the story is as complete as it could be. What we will do, however, is I mean, we, again, it exceeded our own expectations, and it was a reflection of what has to be kind of exquisite target engagement in the glomerulus. That, of course, opens then the question, are there other indications where exquisite control of C3 in the glomerulus would be a good therapeutic approach. And there are, believe it or not, I mean like a long -- it's actually quite believable when you know something about the...

I'm curious, what other settings would you be worth pursuing?

So there's a long list of indications where complement is known to be involved, right? So including IgA nephropathy, FSGS, delayed graft function, FGN, I mean, like it's a list of about at least 10 kidney indications. It's now a careful consideration of what does the competitive landscape look like, what the development time lines look like? What is the benefit that we can offer to patients. So it needs to be integrated with everything else that Empaveli is doing, but very exciting from a patient benefit perspective. And in the months to come, we'll talk more about what we intend to do.

Okay. Well, those -- we follow a lot of those companies as well in IgA and all cards of interesting possible scenarios for combining because those, for example, like Travere, [indiscernible] is a steroid, but Travere, that's maybe like an orthogonal MOA, so it could be interesting. Okay. Very good. So maybe we should spend a little bit of time on ophthalmology. So just give us the latest updates as far as how you're seeing -- how you're seeing the launch progress. We're -- you're now almost -- well, I guess, 7.5, 7 quarters in something like that?

Yes. No, it's been quite a ride to say the least. But we're incredibly proud and happy with what Syfovre has been doing in this disease. It's a new category. It's a new patient population that has never had anything before. And as is always the case, these things need to find their way. This is a space in which complement inhibition, C3 inhibition will be pretty much by itself for the next 5 years. I mean, without any new competition coming around. So it's a big responsibility for us to do it right. Kind of 2 parallel efforts have to happen in that context. On one hand, of course, we are the market leader in geographic atrophy compared to our competitor there, our sole competitor. We want to maintain that market leadership. And last week, our competitor had some unfortunate news for them that I think will drive patients towards being treated with Syfovre. We can talk more about that. But that's an important first element. The second one is to grow the overall market and make sure that every patient with geographic atrophy gets proper access to this drug, right? So at this point in time, fewer than 10% of patients are on treatment with Syfovre or our competitors' drug. So really, I mean, just the tip of the iceberg, not unexpectedly considering how young this launch has been. But there is an enormous unmet need that needs to be addressed. And in the first 6, 7 quarters that we've gone through now, there have been lots of things that happened. And when there's a lot of noise, that can keep people on the sidelines [indiscernible].

Tell us how you've got that -- is it almost 5 years now? How long -- how much time do you have on that?

It is beyond the 4 years.

Beyond 4, okay. That's almost 5.

Yes. It will be 5, that's true. So -- but I mean, really exciting, right? I mean, the largest study in that sense ever done in this disease and really privileged to be able to share that also.

Tell I mean, we want everyone to succeed, but still -- I mean, I remember when Adam Townsend made the point about getting the 2-year data on the label from the outset and that whole situation back then, which we won't discuss too much, -- but basically, that clearly was the right decision. And then -- and now, of course, Izervay doesn't have that claim, at least not for a little bit. So how is that -- how are the retina experts thinking about that because that's clearly an important point?

Yes. I think with the benefit of hindsight, I mean, we kind of -- we took the right decisions there, right? I mean we have a very clear lable, broad label without limitations on how long to treat and with the posology that clearly provides these outlines between 28 and 60 days of dosing. So the majority of our patients are on every-other-month treatment. We now also start seeing the real world evidence emerging from physicians that do lots of injections where you see these effects repeated in the real world. That's something that next year you will hear a lot more about. In the meantime, our competitors took a much smaller approach in terms of their clinical development, as you mentioned, kind of focused on the 1 year. And the second year did not generate the data that was needed to support every other month dosing. And surprisingly, got a CRL also for dosing beyond that first year, which was an initial label limitation that was a bit of a surprise because it's rare to get a label like that for a chronic disease. But this is something that our competitor will have to find a way out of, right? There's 2 elements to bear in mind in that context. Our competitor has no access to every other month, and we don't think they will get that because the price per vial is more or less the same. That means that the cost per patient with monthly dosing is going to be significantly higher than every-other-month dosing as is the case for Syfovre. And that means that Medicare Advantage plans and payers obviously are going to have a preference towards our product.

And they can't improvise, right? They can't take, I mean there's no data to support that?

That's correct. Yes. So starting January 1, that is something that you will see manifesting itself in the sense that when new patients are onboarded for many Advantage plans, there will be an exception that will have to be made if a physician is interested in prescribing Izervay. The second piece with the label being limited to 1 year, it may well be that, that still gets overridden. We don't know why that CRL was issued. I mean that's, of course, for our competitor to figure out. But in the meantime, should it not get resolved, that's, of course, it's not a disease that you have for 1 year. You want to treat these patients for longer. And if that includes having to prescribe it off-label beyond 1 year, then there's, of course, a risk for reimbursement. So, we'll see how it all evolves. But it's a good position for us to come from with a drug that's differentiated, right? Syfovre is differentiated on its efficacy profile and recognized as such is the only drug that can give in as few as 6 times per year and has these increasing effects over time that create this very meaningful slowdown, of course.

I know, obviously, it's been a tougher road across the pond. Is there anything to say there? Is there another strategy? Is there -- could that come back into more focus with more data, real-world data, more KOLs? I mean both you and Iveric, Astellas have had similar challenges over there?

Yes. Unfortunately, we don't see our product being available outside of the U.S. We want to keep fighting for that. But there's an unrealistic expectation as it relates to not just an improvement on function, but an improvement on best corrected visual acuity, which is really the central point of vision, which in this particular disease is not involved the way it is, for example, in wet AMD. So that was just not a bridge that somehow we could cross, which is very unfortunate for patients. Our approach has been from the beginning that we would look at lesion size reduction. In other words, show that we can save retinal tissue from degenerating. And we have done that. Then we use microperimetry to show that the tissue that was preserved can see late. So it's a functional tissue, right? And after a couple of years, a large swaths of tissue. So the unfortunate disconnect with misunderstanding, the best corrected visual acuity was something that we couldn't overcome. And we'll unfortunately keep this therapy away from patients outside of the U.S.

But it's -- like you've explained to me and others many times, I mean this BCVA, this is an old tool, right? I mean, you put it on the wall and you read letters. It somehow may not be the most appropriate assay, so to speak, right, for GA because of the nature of GA and the way that the lesions creep around the fovea and so things of that nature?

That's exactly correct, yes. So this is a disease that kind of leaves a pinpoint in the middle of your vision intact, like because of how the disease evolves. And through that little central point, you may be able to read letters on a screen, right? So when we think about going to the optometrist or the ophthalmologist and you read the letters on the chart, you can read the small letters because whatever area of retina you have left is not blind, it can read it. But imagine looking through a straw, right, or looking through your fist and having to navigate through life, that's what...

You're not going to move your head around trying to see every part of the big letter?

Exactly, yes. So that's the -- so it's a complex disease to understand. We did what we could to educate, but I couldn't cross it. The Retina Community and I mean, patients as well as retina doctors in Europe overwhelmingly supported this product to be approved, but there were other forces that prevented it from happening.

Understood. Let's spend a little time on PNH, if we could. It's doing well, but it's sort of trending to -- I don't know what you want to say, but it's decelerating. So talk about where you see that growth if it's really more of a mature product now. Or how should we think about that for going forward?

Yes. Thank you, Yigal. So first of all, Empaveli is an amazing drug for patients with PNH, right? We see that reflected in 97% compliance rates. We see that reflected in patients that go from Empaveli to the oral alternative that's on the market now and then come back. So patients really benefit a lot from this product. We also -- and this is something that people don't pay a lot of attention to, but we have well north of 2,000 patient years of dosing. We have not seen any problem with meningococcal infections the way you do with C5 inhibitors, for example, right? So the safety profile of Empaveli has also been quite remarkable. You combine these 2, and it provides this what we believe is a best-in-class opportunity for patients with PNH to control their disease. It is a space -- PNH is a great place to show that complement inhibitors do their work. It's very saturated with clinical trials. I mean, I don't know what percentage of PNH patients are in trials, but it's a lot. They are also in the U.S. quite dispersed, not centralized with certain hematologists, and wherever they are, you see hematologists since they have 1 or 2 patients, if you're lucky. They're hard to convince to call that patient to come in. And if the patient comes in to remember that there is a drug to prescribe for them. So it was [indiscernible] battle to commercialize there. But we have found a niche that I think is relatively stable and that we think will largely be maintained over the next couple of years where we can provide that opportunity to PNH patients, but it's, of course, limited insights. I don't know, Tim, if you want to add something.

No, I think you hit it. Very good job.

Okay. Let's talk about pipeline. I mean you've done some enterprising trials, some sort of high risk, high reward, i.e., ALS, which you characterize as a high-risk study. But there's some other programs that are in the earlier pipeline, if you could elaborate. And then you have a program to help with gene therapy, correct?

Yes. So we have a gene editing, right? And we have a partnership with Beam. So in the new year, I mean, we will have an R&D Day in the spring to kind of display all of the things that we have ongoing. So we're not going to talk too much about it, but we have an siRNA program, where we lower the C3 levels by 90% to 95%. That is currently at the end of the initial testing in healthy subjects, and that will go into specific disease indications soon. Very excited about that. We're very excited also about our preclinical work, which is -- we'll have as many as 3 INDs if things go well in the next year -- by the end of next year, beginning of 2026 as well.

Those are disclosed programs? Or what -- can you say more there?

No. So those are programs that we specifically will keep that information for next year.

So you'll do teaser for the spring, okay.

Correct. So the sequence here is what we want to end up with at the end of next year is kind of find that place in geographic atrophy for Syfovre that it deserves, which is a best-in-class profile with a huge number of injections and experience behind it and real-world evidence supporting that profile and a place of normalcy where every patient that has GA can have access to it. Then what we believe will be a very innovative program, a leading innovative program in geographic atrophy as well with Empaveli, the launch, of course, in C3G, IC-MPGN with then an additional or additional kidney indications in registrational enrollment. And then these new programs that I think people will be very excited about that are about to go into the clinic at this time next year.

By the way, are you going to have a different trade name for C3G? Are you going to call it Empaveli or what's the plan there? I'm just curious.

Yes. I mean I think it will still be called Empaveli. It really is the profile that is the drug as it exists today, that similar pricing, everything.

Okay. I do get a lot of questions around the path to profitability and the financing and the cash. So can you just maybe Tim just walk us through how you're thinking about that? I think you've made the point that you can make it to profitability with the growth of the existing business and the current expectations around the OpEx?

Yes. So the way we look at it right now, we look at our expenses, to your point, on a cash basis right now. And if you look at our net revenue, it pretty much equals our cash operating expenses. So we're on an operating basis, more or less cash neutral. What we currently finance beyond that is our interest expense and also working capital. And we obviously have a financing mechanism to take care of our largest working capital need, which is as sales grow, we also extend credit to the channel, so that creates receivables. And those receivables as they grow, are a cash use for us. So ultimately, we do have a mechanism in place to bring those in a little -- that money in a little sooner. So we did that to kind of alleviate any sense of cash need that might be out there. So really, right now, as we said on our earnings call and certainly would love to reiterate that we see no immediate need to raise -- no need to raise capital to run our business as we have it today. So, yes.

And what -- just to remind everyone what was that vehicle that allowed you to limit that risk on the [indiscernible] ?

So that's called a factoring facility and all it does, it means you take some of your receivables and you can essentially sell them. And so you get the cash for those and it's a very modest cost. So we have that. And then to your kind of final point of your question, anything that represents revenue growth from here then begins to cover, right, that interest expense and anything else in working capital. Again, working capital isn't -- in the past quarter really wasn't a big expense for us at all anyway. So we don't guide on when we become cash flow positive or GAAP earnings positive, but that's, of course, that's, of course, something that we see that we'd be able to do with the existing resources we have.

And then the balance sheet. So just to remind everyone, you -- is there -- have you extinguished all the debt? Or is there a piece there that's still existing?

Yes. So we ended the quarter with almost $400 million in the bank. As I told you, we're operating cash flow more or less neutral, and we had $375 million in the Sixth Street facility, which we used to take out the SFJ liability. The SFJ liability that we had, had $366 million in residual payments. They were fixed milestones, and they were happening every kind of 6 months. And so what we did is we termed that out with an interest-only facility from Sixth Street, which was a phenomenal facility. And obviously, and have some of the best terms we've seen in years in a biotech debt facility. So that was very helpful for us, and it matures in 2030. So that's not for quite a bit, obviously. And then we have...

That's a straight debt, not convertible?

That's straight debt. We have roughly $93 million left in our convertible security that we did that we issued 5 years ago now. And so that...

When does that mature?

That matures In September of 2026. And so those are the 2 debt facilities that we have. And I mentioned the cash and then we have obviously the factoring line that we're able to use for the -- but that's not debt. That's really just being able to monetize those receivables.

So what's the plan for the $93 million? You're just going to let it convert or you're going to [indiscernible]?

It doesn't feel like a [indiscernible] and so that doesn't feel like a big scary thing [indiscernible].

Okay. It's only $93 million. All right. Now any other -- what about external activity in BD? Anything -- are you looking at external assets? To what extent is that a relevant part of the business plan?

I mean we have, of course, an important business development unit to evaluate things on a rolling basis. But there is no strategic need right now. So we are -- we have a really good strategy that was put together that we look forward to sharing and 2025 will be a great year for us.

Yes. I would reiterate, we don't have anything that's large and in front of us. I mean we do regularly do very small little scientific BD deals. We're very active in that area, and these are things that we augment our discovery efforts with. So whether that was working together with the company to develop our siRNA or whatever, it's those sorts of things. They're not big dollar things. I don't envision a big dollar transaction happening in the short term. We have a lot on our plate, and we're pretty comfortable that we have great opportunities ahead with our native opportunities.

Okay. Well, we have some more time. So a few other kind of grab baggy questions. So everyone's asking about a few things AI. Does that feature in any way in your organization, either for efficiency purposes or actually for real drug development or not?

So yes is the short answer, right? I mean, I don't think any company can afford to not look into that. We kind of implementing it within our system is a challenge, right? I mean it needs to be complaint. It needs to be -- you cannot -- you have to make sure your IP is protected. I mean there's a lot of guardrails around it. So where we currently use or are exploring AI is in document generation, of course, in cybersecurity that takes a big priority for us. And the development of -- in the laboratory itself, we use AI through third parties and then also in imaging in the [ eye ]. So those are kind of the 4 areas where we are most active.

Okay. And then as far as the marketing efforts with the social media and of course, the Henry Winkler and all these other -- so you -- how is that going? And do you expect to leverage that sort of effort for -- I mean, for C3G, maybe it's not really necessary, right? But I just...

Yes. So that is -- Henry Winkler is going to be back for us, branded this time, starting in January, really an amazing.

[indiscernible] the next fireside?

Sorry. Well, ask him. But really, really amazing. I mean he's incredible. And he's very personally invested in this, because of his father-in-law. So it's been a great collaboration for us. What we will do there is essentially identifying patients, right. We will recognize them, identify that they have the disease. And then we will make sure that these patients find the right retina doctors to take care of them. And that's going to go in synchrony with what I look forward to next year as well, which, as I mentioned earlier, is going to be a much more quiet place, right? I mean it's not very complicated, right? When you look at the data, when you know what you need to know about this drug, if you have geographic atrophy, there's a drug available. That discussion should happen between a retina doctor and a patient and if the patient is interested, the drug should be made available. And I think we're going to get there. And fewer than 10% of patients have been treated. So we have a big job ahead of us.

Okay. Another new question, which only emerged after November 5th or 6th or whenever the election was. So I mean, on the manufacturing, just remind everybody, where do you source -- how much is sourced internally in the United States versus anything offshore as regards to the potential, more protectionist trade policy that could happen?

Yes. So this is not something that we are concerned about. We don't manufacture in weird geographies or geographies that would be at risk. And we have redundancy in manufacturing as well. So this is really not something that we are too concerned about. Of course, very aware of it and very on top of it, but not concerned.

Okay. And you don't have to answer this one, but you can if you want. So any thoughts on the potential changes in leadership at the following HHS, CMS and the FDA?

Let's see what happens. I mean I think that it's in all likelihood going to be quite different. But when people talk about change at the FDA, there's kind of the desire to implement change and then just the reality of things as well, right? It's not like drugs get approved because they look good or smell good. I mean like usually, data do play an important role in decision-making there. And to think that change in philosophy can drastically change how many drugs get approved or not approved, it's just not in touch with reality. I think that I have to believe that well-designed confirmatory studies are going to be the mainstay of the approval process as it should be, right? People that work at the FDA and that do the work, have a way of going about it that is very standard has led to incredible innovation in our world in the last 50 years. And I don't see that changing overnight.

[indiscernible] maybe a more concrete question. I mean given the change in leadership specifically at your division, does that impact you in any meaningful way? Or I mean, you're obviously approved, so it's kind of in the past, but I'm just wondering if that has any relevance now for you?

The ophthalmology division?

Yes, yes, yes.

Well, I think look, I mean, Bill Boyd is a great leader, very by the book. And as you said, I mean we are approved. It is not something that we -- but they're very good in collaborative organization. So I think Wiley left it in great hands. And you don't want that the FDA surprises or things that you feel are left to factors that are not under a good protocol and process and that definitely doesn't seem to be the case in this division.

Perfect. Okay. Well, thanks again. We'll have Henry Winkler here next year.

Thanks, Yigal.