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

September 16, 2022

NASDAQ US Health Care Biotechnology conference_presentation 38 min

Earnings Call Speaker Segments

Tazeen Ahmad

analyst
#1

Thank you, everybody. Hopefully, you can hear me. Good morning. Welcome to be Bank of America Healthcare Conference line from London. I'm Tazeen Ahmad. I'm one of the biotech analysts here at the firm. It is my pleasure to have our next presenting company. Sitting here with me this morning are 3 members from Apellis, CEO, Cedric Francois; Chief Commercial Officer, Adam Townsend; Chief Financial Officer, Tim Sullivan. Good morning, gentlemen and thank you for making the trip over.

Cedric Francois

executive
#2

Good morning. Thank you. Happy to be here.

Tazeen Ahmad

analyst
#3

So I think everyone else is saying is familiar with the company so we can skip over the intro and go straight to, I think, the main questions.

Tazeen Ahmad

analyst
#4

So as you edge closer to becoming a commercial company, I think it might be worthwhile to get a better sense, and maybe this is a question for Adam, on how you're thinking about the GA market because there's nothing approved, you would be the first approved drug to enter the space. Can you just talk about the general challenges of creating a market where currently there isn't one, but at the same time, can you talk to us about -- it's obviously a large market and what proportion of it do you think you can get to.

Adam Townsend

executive
#5

Yes. Great question. Thank you. So obviously, we flexed our commercial muscle a little bit with the launch of PNH just over a year ago. So we've built all of the infrastructure that we need as part of that PNH launch to get ready for the GA launch. So the first part of your question was some of the challenges and obstacles. Obviously, it's a very large patient population, vastly different from our PNH patient opportunity. So there are 1 million patients in the U.S. that have been diagnosed or have some form of diagnosis for geographic atrophy, and 4 million patients outside of the U.S. So you can see how big an opportunity it is. We have the potential to be the first treatment for GA patients. So what we've been doing now is really educating the potential prescribers on, there's a new GA drug coming, here's our data and getting them ready to be prepared for when they can start to treat patients. So the second part of your question was the size of the opportunity. So 1 million patients in the U.S. Based on our market research, about 60% of those patients currently sit on the books of either an optometrist, an ophthalmologist or a retina doctor. And all of that, 60% half sit on the books of retina doctors already, right? So there's already a bolus of patients that sit there. We think the majority of those patients are very treatable with our drug, and we expect very quickly after launch that physicians will start to call patients into their center because, of course, they haven't had any treatments to give those patients outside of vitamins. And they'd likely prioritize their patients on certain patient subsets. And will move those patients within their centers pretty quickly.

Tazeen Ahmad

analyst
#6

So if I'm getting the math right, is it around 300,000 or so patients that retina specialists have access to?

Adam Townsend

executive
#7

Just to touch more than that at the moment, but there are a lot more than that sitting with ophthalmologist and optometrists, yes.

Tazeen Ahmad

analyst
#8

So if we start with, I guess, what I'll call the lower-hanging fruit, which is the patients that the retina specialists have. How often do they see those patients? Until now there has been no treatment. So I guess when you say they'll call the patients in, how long is that going to take, realistically?

Adam Townsend

executive
#9

Yes. So they tend not to see those patients that frequently, right? So what they'll do is if the patient has a symptom or something like that, they may see the patient or if the patients tends to be pushed back to their house and saying, come back if you have any issues, but at the moment, outside of vitamins, there's not a lot I can do for you. But they're all on the books of these retina practices. So the practices that are very well-oiled machines, know where these patients are, how to get in contact with them. So we'll have an opportunity post PDUFA to be -- to allow centers to contact those patients and call them back in to talk about the potential new product.

Tazeen Ahmad

analyst
#10

Okay. And I think you have started your commercial go-live process almost. So can you tell us how many people you've hired to be, I guess, total commercial organization as well as field force?

Adam Townsend

executive
#11

Yes. So we have -- I'll start with the field force because that's the question we get the most, right? So we actually have in field, as of last week, 100 field-based employees. And that's a cross-functional approach through medical affairs salespeople and field reimbursement managers. So what we did is we did a lot of research to compare to the way AMD companies to see what was the right scale of field-based infrastructure for us to have. And we believe that that's the right size to hit. We're going to target 2,600 retina doctors in the U.S. So we think that's exactly the right size and scale to talk to those 2,600 doctors. So they're in field now they're doing disease state education with all of the practices. And obviously, post PDUFA, they'll pivot to commercializing the product.

Tazeen Ahmad

analyst
#12

And as far as their previous experience, is it safe to assume that they are coming from related areas I'll throw in with AMD sales people or maybe even dry eye sales people, who knows. But I guess the question is, do you feel confident that, that sales force has already established relationships with the retinal specialists that you're targeting?

Adam Townsend

executive
#13

Yes, it's a great question. So we got 3,000 resumes for the 100 physicians that we hired And obviously, the 100 people that come from retina companies, they come from ophthalmology companies, large companies as well as small companies, too. So we try to get a balance of experience of good relationships, great knowledge, professionalism, et cetera. So we're thrilled with the approach that we have. All of them will have knowledge of the retina or of the eye, and can hit the ground running post PDUFA. So we're thrilled with the talent that we attracted.

Tazeen Ahmad

analyst
#14

Okay. So maybe now let's back up a little bit to some of the things that have just recently occurred. So maybe this question is for Cedric. You recently had your mid-cycle review meeting with the U.S. FDA. And to the extent that you can, can you just give us an overview of what topics were discussed? And then, of course, the all-important question you reiterated, of course, that people have been asking you, which is that as of that last meeting, FDA continues to say that there is no need for an advisory committee meeting.

Cedric Francois

executive
#15

Yes, that's correct. So the mid-cycle review meeting took place and the feedback that we got most that everything is on track. And we -- there's really nothing that is...

Tazeen Ahmad

analyst
#16

Was it a live meeting?

Cedric Francois

executive
#17

No. It was not live meeting. Because -- I mean they met -- so the mid-cycle review is then without a threat. And then they come to us if they have questions. That's that. And so everything is on track. Still no AdCom as was the case when they accepted the filing 2 weeks earlier than they had to. So it's been a really great process for us. And I think it's important to note, I mean there's quite a disconnect between kind of the whole -- what's happening on the outside world and how straightforward it has been with the FDA, specifically. And I think people forget that Wiley Chambers and his division for about a decade, right, have worked on creating the circumstances for an approval process in geographic atrophy. Sometimes we get the question around, well, visual acuity, this and that. Well, the reason why visual acuity is not a primary endpoint in GA studies is because VA is a couple of pixels in the middle of your large TV screen that you need to read the letters on the screen, right? Can look through a straw and actually have 2020 vision, but our fraction will, of course, be severely impeded. And the FDA went through a whole process with PNH over a 2-year symposium or workshop to come with that conclusion, hey, we have instruments that with micron level resolution allows us to look at living and dying photo receptor cells. That is what will be the primary endpoint of studies. Of course, Genentech and Roche were the first to take advantage of that and now us. A secret way of running these trials, evaluating them in the U.S., but also in every regulatory jurisdiction that we spoke.

Tazeen Ahmad

analyst
#18

Okay. I'll come back to VA in a minute. But just to wrap up on the meeting. Are there still asks of you guys from the agency to submit things to them at this stage? Or is it mostly a question and answer that doesn't really require much?

Cedric Francois

executive
#19

No That is it. So we have to be the [indiscernible] of course, which has happened or is about to happen, but there's nothing in there that is unexpected. And next step is labeling discussions have been well.

Tazeen Ahmad

analyst
#20

So as far as that 24-month data was concerned, just for -- to be clear, what we saw in the press release, is that what you sent the FDA? Or did you have -- did you send them more information than what was in that press release?

Cedric Francois

executive
#21

No, we communicated to them what we communicated publicly. And again, kind of briefly going back to the submission. So we submitted the 18-month data. But when we did, the FDA saw all of the data that we had available beyond the 18 months as well, right? So there's nothing that came out of that. That was a surprise to anyone. If anything, it was a positive surprise, right? Because the reduction in the lesion size was -- far exceeded our expectations and what we expected based on what we saw at 18 months.

Tazeen Ahmad

analyst
#22

Okay. So obviously, the FDA has a discretion to do what it wants whenever it was. But realistically, again, based on your interactions with them as your PDUFA is approaching in November, what do you think the chances are that they could still decide to hold that outcome?

Cedric Francois

executive
#23

Close to 0. So for them to do an AdCom at this point in time, would mean taking out the priority review because there's simply no time anymore and returning it to a normal review process, which would be an extraordinary measure based on nothing.

Tazeen Ahmad

analyst
#24

Yes..

Cedric Francois

executive
#25

Correct? So I want to kind of reiterate that we got the feedback from the FDA no AdCom, 2 weeks before they actually had to give us that feedback. That is how clear the story was from their perspective, and that has continued to be the case.

Tazeen Ahmad

analyst
#26

Okay. So you mentioned that labeling discussions will start. So you haven't yet started that. What's going to be -- what is entailed in a labeling discussion, can you just talk to us about things that are going to be important for Apellis to have in the label?

Cedric Francois

executive
#27

One of the great things, I think, that we were able to do is to have the FILLY DERBY and OAKS trial and run in a very consistent manner, right? So we have the exact same patient populations same way of measuring, same way of analyzing. All of that was deliberately kept consistent so that we -- the variability of the disease is enough to deal with to also include variations on these et cetera. So that's all been very consistent, and was designed to address the broad GA population, meaning patients can present either with what are called subfoveal or extrafoveal lesions where the fovea's not involved yet or when the fovea is involved, foveal patients represent approximately 60% of the overall population of patients with GA. And then also, of course, we evaluated both monthly as well as every other month injections with every other month giving us approximately 90% of the benefit that you get with monthly injections. And needless to say, I mean, we've seen what's happened with Eylea, with VABYSMO, et cetera, less frequent injections. There's an enormous advantage for physicians and for patients to use in their practice. So if you think of that as 4 quadrants, foveal, extrafoveal, monthly, every other month, the effect size in terms of reducing the lesion growth between month 18 and 24 is actually very similar. And we submitted all of the data to FDA. Hopefully, all of that will be included in the label and make it, we believe, as easy as possible for a retina doc to take care of their patients.

Tazeen Ahmad

analyst
#28

Okay. Yes, let's maybe focus a little bit on the monthly versus every other month. The doctor checks that we've been doing indicate that physicians are particularly excited about the potential for every other month. Maybe, Adam, can you tell us what your feedback has been as you've kind of asked doctors what they would feel is ideal, and why you think it would be important, if you do, to have the flexibility from monthly versus every other month.

Adam Townsend

executive
#29

Yes. So in our market research, which we did after the 18-month data readout, and I expect it to be exactly the same after people see -- that have seen the 24-month data readout. 99% of physicians in the U.S. gave us the feedback, give us those 4 quadrants, that Cedric talks about, give us the flexibility to be able to treat monthly, every other month, foveal and extrafoveal. In the real world, I do expect every other month to be the dosing schedule of choice, right, just the efficacy that Cedric says is nearly as powerful and also the convenience for patients and the flexibility offers patients, I think, is going to be particularly strong. Now when we get into the actual market, as Cedric described, the demographic at the moment is there are a lot more foveal patients because there's been no treatment. So physicians very quickly come to a couple of subsets that they know top of mind patients, they could name a patient that they will bring in. And so they immediately will be able to name a patient who is blind in 1 eye and has foveal encroachment on the other eye, and they would like to use our product to slow down that progression, and they would likely use that as monthly dosing is the feedback that we get. But immediately in the same conversation, they can identify an extrafoveal patient who they want to stop that progression as early as possible, and they think every other month is the real strong differentiator there. So that flexibility of usage is really important to a retina doctor for the best care, for their patients. But I think every other month will be the dominant usage within the market.

Tazeen Ahmad

analyst
#30

So let's play scenarios for a second. Let's say, for whatever reason, FDA, in the label, says it's approved for monthly injection. How does that impact your view of excitement from doctors' ability to get traction in a real-world setting? How important is that?

Adam Townsend

executive
#31

So I think, again, based on our data set that, that scenario is not as likely, but in this assumption, I think monthly is still a very, very good choice for a certain subset of patients. And I think it's a very viable opportunity, particularly for those more severe patients to use it. But in the real world, I honestly still think that every other month will be the usage of choice.

Tazeen Ahmad

analyst
#32

Okay. Let's talk about foveal versus non-foveal. So I think -- so there was a competing dataset that read out recently, which I think adds value to the thesis that complemented vision is a good way to treat GA. But in terms of patients that are more advanced, what's your view on the utility of treatments for a patient who already has foveal involvement with PEG?

Cedric Francois

executive
#33

Yes. So what's fascinating to observe is that in the first year of treatment, the effect on foveal patients was relatively small compared to extrafoveal patients. Whereas in the second year, and particularly by month 18 to 24, there's a full catch-up that has happened, right? But clearly, foveal and extrafoveal patients behave differently when you look at the data set that we have available. Thankfully, both respond well, just that foveals are a little bit behind on the extrafoveal response. So I think that, again, those populations are very important. Foveal patients are 60% of the overall population. I think we'll all be radial doctors.

Tazeen Ahmad

analyst
#34

So do you think -- what do you think would be easier initially to gain traction with once you're approved patient-wise? And how should we be thinking -- again, we're jumping ahead a couple of steps because you still need to get approved. But how should we be thinking about the cadence at least initially of the launch? Should we expect that because you had a pretty large clinical trial program that there should be some low-hanging fruit and therefore, out of the gate, you'll be pretty steep. Or should we be thinking about it more on lines of the first half to get on to formulary, so it could be a flatter launch?

Adam Townsend

executive
#35

Yes. So the first part of your question was the patient segmentation, basically, which patients, I think, has -- as we've said previously, it's going to be a healthy mix of foveal patients and extrafoveal patients. And I think eventually that once we start to treat the foveal patients, that Cedric says is 60% of the population, I think you'll start to see it skewed towards the extrafoveal patients. And in our research, physicians already have started to identify which type of patients they would treat with a potentially approved product. Now the second part of your question was what does it look like post PDUFA? So PDUFA is 26th of November. We are assuming a launch for us in the first couple of weeks of January, purely because of the timing of the PDUFA, and what we want to do is we will then bring our field-based teams in post a positive PDUFA back in, train them on the label. And then what they'll do is they'll prime the retina physicians to say we now have an approved product. Here is the label. This is how you would order our product, how you would get it into your refrigerator and give those retina centers time to reach in and start to schedule patients to come in and visit for the month of January. So out of the gates, post-PDUFA, we're assuming our launch phase starts in January. A few things about the launch phase right. It's the first ever GA potential ever GA treatment there's no permanent J-code for GA therapy. So within the first phase of the launch from January, we would submit for a permanent J-code, which just helps physicians guarantee reimbursement for their product. And we would use a temporary J-code until probably June, July time when we would hope to get an approved permanent J code. So some physicians in smaller centers might wait for that permanent J-code because it helps them get reimbursement. Another group and population of physicians have told us that they will test by purchasing a vial and trying to get reimbursement through a local Medicare site or a local plan and see what the response is. And they did the same thing for the reason where AMD launches right. They go out and say, can I get reimbursement for this drug covered by this plan or this group of plans? And if the answer is yes, then they know that they can confidently do more and more patient. And if the answer is no, they tend to wait for that permanent J-code for that plan. So we'll work through all of that. There are some very strong tools and tactics that we can use that help those physicians through that time period for the first 3, 4, 5, 6 months when they're waiting for that permanent J-code. Post permanent J-code, it's full speed ahead.

Tazeen Ahmad

analyst
#36

Okay. So you mentioned something important in your description that physicians have to order the product and store it in their office. So how is that going to work? Do they have to pay for the product to be delivered to their office ahead of time? And is that going to be rate limiting for the early part of the launch? You haven't talked about pricing, so maybe let's talk about that.

Adam Townsend

executive
#37

Sure. So yes, so obviously, physicians now if you go into a retina practice, you will see a refrigerator full of wet AMD vials. And so what you should think post January is that there will be another refrigerator with our GA vials in it. So what happens is that physicians will order the vial, put it in their fridge and then when they put it into the eye of a patient, they'll seek reimbursement for that type of vial. So, that's how it will work simplistically as we get into the January phase of the launch. So pricing, it's a great question. We get asked a lot. So we've done all of our research with retina specialists. We also include some ophthalmologists just for a benchmark and with some payers. And the consistent feedback we get is you need to price within the range of the wet AMD vials. So physicians buy vials, right? So they don't look at it at an annual level, they look it at a per vial price. And the benchmark for the vials subject to which wet AMD product you're talking about goes from about $800 a vial to approximately $2,400 a vial. So consistently within that range, we get told by retina specialists. If you can use our drug, please make sure that you fit within that range just because that's something that we know, we're used to. We know how to balance that range based on our experience from the wet AMD treatments. So that's a likely good range for us to look at, and that's been consistent through our research. Now obviously, we need to wait and see what our label is before we make our final decisions on pricing.

Tazeen Ahmad

analyst
#38

Are you going to be offering any kind of program to subsidize the cost to physicians when you launch?

Adam Townsend

executive
#39

So we have done all of it again, all of the thorough research on what's currently offered to physicians about getting access to the vial and payment terms and samples, et cetera. And we have a very nice, robust compliant approach of tactics that we can use to help physicians get access to the product.

Tazeen Ahmad

analyst
#40

Okay. This is going back on several years, and I'm going to just ask you because it popped into my head, but what was the launch trajectory, of the early days, let's say, for Eylea. So before they got their permanent coverage code. And maybe that's not even the most fair question because Lucentis was there before, and that market was already established. But can you give us a sense of how much the J-code actually helped once Eylea got that J-code.

Adam Townsend

executive
#41

Yes, I think you'll see that the J-code really unlocks the potential of the product because it just means that physicians have no qualms, worries about seeking payment and getting payment for the reimbursement for the product. So the past is a hard one to triangulate against, right? So the wet AMD products keep building on the current launch -- the previous launch of the wet AMD product. This is the first-in-class potential launch at GA. So that J-code is going to be a critical piece of our strategy. I think post June, July, if we submitted January, which is our plan, then it's level playing field with all of the other wet AMD drugs, and anything else that required a permanent J-code.

Tazeen Ahmad

analyst
#42

Okay. Let's talk about clinical benefit because I do get a lot of questions on this, as I'm sure you do. Specifically, going back to Cedric's comments about visual acuity gains. Now VA was not the primary endpoint of the study, but you did examine it. And at 24 months, I think some investors had the question of when should we realistically expect to see meaningful benefit in VA. At 24 months, there was actually a couple of letters lost for the monthly versus every month dose. Does that mean anything? Or is that background noise?

Cedric Francois

executive
#43

It's background noise, right? So it's a letter up, a letter down. And even [indiscernible] will tell you that that's irrelevant. The timing over which you should see it remains to be seen. But I want to again go back to what VA really means in order to understand that, right? So VA is something that you measure by having a patient read a chart. And if you look through a straw, you can have 20/20 vision, but of course, your function would be severely impeded. In geographic atrophy, there's something called foveal sparing. So actually, the fovea is the last piece of your retina to go. So if you have an active arm of about 200 patients, you need to look at the patients that actually are at risk of losing that central vision in the first place. And those are the ones that are going to be driving the differences in your VA. So it's just -- it's a very narrow band within that large group of patients that are going to -- that you have to look at. So either you enrich the trial for those patients or you have to look for a longer period of time. We are currently doing the investigation between function, not just VA, but also all the other ones, right? And with the lesions in order to have an idea about exactly what you're asking us. And so that is what we will present as part of our package to the EMEA.

Tazeen Ahmad

analyst
#44

Okay. Upcoming at AAO at the end of this month, you will be presenting additional data. Can you talk to us about what to expect there?

Cedric Francois

executive
#45

Yes, we'll just be kind of more detail, more consistency around what we have already presented. We are particularly excited about that increased slowdown in the lesions, right? So while we won't be able to empirically test it, and though we have GALE, and we will have a sense if these compounding effects that we see were to continue and you draw a line, I mean you're talking about 50% or so slowdown after 4 years, right? So that's something that we'll be able to continue to evaluate. We'll hopefully also have some early indications as to what the functional story for EMEA will look like. But all in all, there won't be a lot. Obviously, we're only months beyond the top line.

Tazeen Ahmad

analyst
#46

Yes. So that 4-year mark that you just mentioned, we've talked about this before. And so maybe I'll ask Adam this question. There's nothing approved, obviously. These patients are in need of options. But in terms of what you think is practical, do you think that once a patient goes on therapy, it is a commitment you have to go to the doctor's office, either monthly or every other month to get an injection. Do you think patients and their physicians will be patient enough to stay on therapy consistently for 4 years?

Adam Townsend

executive
#47

Yes. That's a great question based on our patient research that we've done, patients are highly, highly motivated to seek treatments for GA. We give a lot of comments around if there's anything I can do to help my vision or stop my lesion from growing or something along those lines. I'm going to seek it. And they strive for that conversation with the physician. And I think at the end of the day, our physician is going to have a conversation with a patient and say, look, dying retina cell is, when they can't see. It's not a good retina cell. So if there's something that we can do that can help prevent that, I think that's going to be critically important. The patient drive is huge. So I actually think that there will be a very strong movement from the patient population to seek treatment. And that every other month dosing, I really think it's going to be a game changer for that patient that wants to continue with their therapy, having that flexibility of every other month of dose.

Tazeen Ahmad

analyst
#48

What percent of patients do you think will also be on concurrent anti-VEGFs?

Adam Townsend

executive
#49

Yes. Based on our research, it's about 30% to 35% of GA patients that will have some form of wet AMD issues or administration.

Tazeen Ahmad

analyst
#50

So let's say a patient needs both injections, how is it going to work for the physician? Do you think that the physician has to make separate appointments for each injection? Or do they come and get both at the same time? And I think importantly, how would a physician be reimbursed for that as well?

Adam Townsend

executive
#51

Sure. It's -- so it differs a little bit by practice. Obviously, they have their own routines of schedules when they have patients come in. I think it's highly likely that they would do the administration on a separate day particularly within the first phases of our lunch in particular, right? So I think that's going to be the normal practice. As it comes to reimbursement, my understanding is that physician will obviously get reimbursed for the 2 products, and we'll get reimbursed 100% for the administration of the first eye. So this is if you're treating 2 separate eyes, to use this example, and 50% reimbursement for the administration of the second eye.

Tazeen Ahmad

analyst
#52

And I guess economics-wise, is that something that doctors, based on your conversations, are comfortable with?

Adam Townsend

executive
#53

Doctors are highly motivated to use the potential first-in-class GA product.

Tazeen Ahmad

analyst
#54

Yes. Go ahead.

Cedric Francois

executive
#55

There's one other thing I'd like to add. So when we talk about concomitant use of anti-VEGF and this potential GA products, 1 thing is for patients with geographic atrophy to develop oxidations. There is also the whole population of patients with wet AMD on treatment with anti-VEGF who do develop geographic atrophy. And that happens with an incidence of 15% to 20% per year. So when you look -- and that has actually been studied after 7 years of treatment, 97% to 98% of patients will actually have geographic atrophy. And most of the retina docs that we've spoken with will tell you well if I have the patients on anti-VEGF who develops GA, I want to slow that down. I would use both drugs.

Tazeen Ahmad

analyst
#56

Now maybe let's jump to what you just said for patients who develop oxidation while being treated. Has FDA brought that up at all as a point of concern. I know at the beginning, maybe like 1 year, 1.5 years ago, that was a question mark about what the [ C-t ] profile of PEG was going to look like. Based on your Phase III results, a lot of that has been put to rest, but I'm just going to clarify, are you getting any specific questions that indicate any kind of concern from the agency around safety profile.

Cedric Francois

executive
#57

No.[indiscernible]

Tazeen Ahmad

analyst
#58

Yes. Okay. So maybe let's now talk about what you think the overall market is going to evolve to. So figures cost you will be the first so much into the space. There is certainly a first mover advantage. We would expect at least 1 more entrant maybe over the next year or so after you launch, and then the potential for maybe 1 or 2 more beyond that. Now looking maybe 3 years ahead when there are multiple options for doctors to choose from. What would you say would be something that would have physicians prefer your product to anything else that might be out there in the complement space?

Cedric Francois

executive
#59

Yes. So we've done -- we've been very fortunate, but we have built something that will, I think, create a very strong competitive position, right? First, we have the first mover advantage, which is huge, obviously, in this disease. We have every other month dosing, which is huge in this disease. We have 18 months, which will in all likelihood find us weigh into the label. The FDA thinks about to slow at 18 months and there again OAKS is the primary endpoints. So we believe that we will have 3 positive studies with a favorable safety profile in our label as well. Talking about the safety profile, we have a treatment emergence adverse event profile that is very similar, close to identical to what you get with anti-VEGFs. So physicians are very comfortable with that and used to that. So putting all these things into the equation, imagine a retina doc has been using [ Japanese ] product for a year, can choose between monthly and every other month does not have to make a distinction between extrafoveal and foveal patients. Does not have to worry about an extrafoveal patient becoming foveal and then having to discontinue treatment for a product that may have a more narrow label. And a competitor comes in with less efficacy on a monthly dosing regimen compares to every other month dosing with the one that you are using and 1 that is limited to only patients with extrafoveal lesions. That is, we believe, the best case scenario for that potential competitor, and I think it will be a tough path of entry.

Tazeen Ahmad

analyst
#60

So talk about Europe before we run out of time. Where are you with that? Are you open to a partnership potentially for Europe? And maybe that's a question for Tim.

Timothy Sullivan

executive
#61

That's for all of us. But at the moment, no. I mean -- our plan is to build out Europe on our own, right? We've made that strategic decision. We think we can do it just as well as anybody else. It's a concentrated prescriber base and community that basically feeds information about the disease state and what's available. It's very something we think we can do with a pretty reasonable infrastructure. I think Adam can talk about that. But from a cost perspective, it's something that -- really is something we can do on our own without much trouble.

Tazeen Ahmad

analyst
#62

Okay. And where are you with the application process?

Cedric Francois

executive
#63

End of the year.

Tazeen Ahmad

analyst
#64

And would they -- so if you complete your application at the end of the year, would you expect to be approved next year? Or could that be tight?

Cedric Francois

executive
#65

It would be approximately a 1-year turnaround.

Tazeen Ahmad

analyst
#66

Yes, so end of '23 approval here?

Cedric Francois

executive
#67

We're not going to comment to a specific time, but we believe that the average review process would be approximately 1 year.

Tazeen Ahmad

analyst
#68

Yes. We usually in our space model a European launch about a year after U.S. launches. So is that reasonable?

Cedric Francois

executive
#69

That's a clear assumption.

Tazeen Ahmad

analyst
#70

Okay. And then maybe just to wrap things up, how are you thinking about cash needs as you approach the launch? And I guess what's your view on business development, in general? The last year has seen -- a lot of biotech stocks have a lot of volatility in their share price, early-stage companies, et cetera. Are you open to looking to bringing in external assets?

Cedric Francois

executive
#71

I'll start with that, and then I will let Tim answer the rest. But that's the -- look, at this particular point in time, we have I think done a fantastic job, building early-stage developments, pre-clinical development all the way to commercial. In the next year, we have 2 INDs coming online that we're very excited about. We have the mid-stage development with EMPAVELI as well. We're going to have the Enable devise to help us make the administration of EMPAVELI more convenient for patients and a whole bunch of other things, including our collaboration with Beam and potentially the first data on gene editing it complements. So for now, that is enough for us to see what happens. And Tim how do we pay for this?

Timothy Sullivan

executive
#72

Although last year I will tell you has been a really fun year as a CFO, making sure we're well capitalized and appointed tumultuous -- and too much of its time post data post primary endpoint data a year ago. But now we're in a pretty good position range. We have $850 million in cash at the end of the second quarter, and we see that gets us into the first quarter of 2024, which is luxurious runway for us. We've never really had that level of runway. So we haven't been out on smoke. We've been looking at other ways to raise capital because we think once we actually get to that point, we're going to need some sort of war chest in the bank partly, maybe to do some business development. But today, just to Cedric's point, from a business development perspective, we're mainly focused on bringing in early-stage technologies, things that don't cost too much. We don't really have the capital to do much more than that, but maybe downward.

Tazeen Ahmad

analyst
#73

With that, we will end the session. So thanks so much for coming over to London, and it was pleasure going to catch up with you again. Thanks, everybody, for listening.

Cedric Francois

executive
#74

Thank you.

For developers and AI pipelines

Programmatic access to Apellis Pharmaceuticals, Inc. earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.