Hello, and thank you for standing by. Welcome to the Q3 2022 Apellis Pharmaceuticals Earnings Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker, Meredith Kaya, Senior Vice President of Investor Relations and Strategic Finance. Please go ahead..

Good afternoon, and thank you for joining us to discuss Apellis’ third quarter 2020 financial results. With me on the call are Co-Founder and Chief Executive Officer, Dr. Cedric Francois, Chief Commercial Officer, Adam Townsend, Chief Medical Officer, Dr. Federico Grossi; and Chief Financial Officer, Tim Sullivan.

Before we begin, I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now I’ll turn the call over to Cedric..

Thank you, Meredith, and thank you all for joining us today. Let me start this call with what is on all of our minds right now, which is our decision to submit the 24-month efficacy data from the Phase III DERBY and OAKS Studies to the FDA.

This submission will be considered a major amendment to the NDA, extending our revenue timeline by 3 months with a new PDUFA expected in February 2023. Let me just state upfront, as we have received so many questions about this that this decision was ours. This was not requested by the FDA.

The reason why we decided to do this is because including these efficacy data gives us the opportunity to have the best product profile at launch with minimal impact to our launch timing. Recall that they already had the 24-month safety data as part of the 120-day update.

The inclusion of these additional data in the label would allow us to better educate physicians and patients with a clear message around the robust treatment effect of pegcetacoplan over the full 2-year period.

Remember, at 24 months, both every other month and monthly treatment with pegcetacoplan resulted in meaningful slowing of GA progression with increasing effects over time. Between months 18 and 24, the combined studies showed effect sizes of 24% and 30%, respectively, with every other month and monthly treatment.

Importantly, at month 24, the data were remarkably consistent between DERBY and OAKS, meaning that we can spend more time discussing the efficacy of the 2 studies rather than the differences between them. And we continue to see a favorable safety profile in over 1,200 patients with nearly 12,000 injections.

Now let me talk about why we did this now, which we recognized appears unusual given how close we were to our original PDUFA date. At the time of our 24-month top-line readout in August, given how strong the data were, we had the discussion internally as to whether we would file a major amendment.

We decided against it because we believe that it would delayed the timing of our launch and the timing of our permanent J code by 3 months. We also did not expect the 24-month data package to be completed before the PDUFA without compromising the European filing deadlines.

However, as we continued to prepare for the launch, some of these factors changed. The completion of our 24-month data package happened faster than we expected, putting us in a position to submit the data prior to our PDUFA without delaying our European filing.

Also, given the December holidays, changes to medical coverage at the start of the year and finalizing the supply logistics, we had already made the decision to launch in January, which also meant that we would receive RGA code in October.

The combination of these factors meant that the impact of the extended review period would only be a 6-week delay to commercial launch with no impact on RGA timing and the best possible label. The FDA is aligned with our decision to submit this data. We understand that this game as is suppressed and we did not take this decision lightly.

There is a significant unmet need in this disease and patients are waiting for a treatment, but we also strongly believe that this is the right decision. It is the fastest way to get our 24-month data into the label and to deliver the best product profile to physicians and patients. The U.S.

approval is the first step in our overall strategy to bring pegcetacoplan to GA patients around the world. We remain on track with our EU marketing authorization application and plan to submit RGA MAA [ph] by the end of this year. Turning now to the rest of the business.

The EMPAVELI launch continues to progress well in its second year on the market with U.S. product sales of $17.7 million in the third quarter. Globally, our partner, Sobi, is also making progress in bringing Aspaveli to pre-COVID PNH. Beyond PNH, we continue to advance EMPAVELI as a transformative therapy for other rare complement-driven diseases.

AAV-based gene therapy products and neurodegenerative conditions. And our early-stage pipeline, including both our collaboration with Beam and our internal programs continue to advance. And with that, I will turn it over to Adam..

Thank you, Cedric. I will start with our commercial plans for pegcetacoplan in GA. The team is excited by the potential of having the 24-month data in the label at launch. Physician perceptions of these data has been very strong.

Based on both recent market research and direct feedback we have been receiving as recently as last week at the Retina Society meeting. In any launch, the label is the most important document that you can have.

Having the 24-month data included in the label allows us to have a more impactful conversation with the physician, broadens how they think about using pegcetacoplan and allows them to have a more meaningful conversation with their patients.

With a minimal launch delay, it became clear that including these data in the application was the right decision. We have approximately 100 people across our commercial and medical teams currently engaging with retina specialists, working to build a sense of urgency around GA treatment through disease state awareness and education.

We will continue this disease state education until approval. I am impressed with the talent of our expanded team who come from both large and small companies and bring significant expertise in launching new drugs within the retina. They are incredibly motivated to bring the first and only GA therapy to market.

Now let me turn to our current commercial product, EMPAVELI.

In the third quarter, we continued to see positive trends across the key leading indicators for this patient population, including approximately 30 stack forms, 40 additional physicians receiving REMS certification, high patient compliance rates, and continued strong access among the top 20 payers. This resulted in $17.7 million in U.S.

net product sales for the third quarter. As mentioned on the last quarterly call, following EMPAVELI's first year in the market, we have expanded our focus to the broader PNH community by further positioning EMPAVELI as first-line treatment for every adult living with PNH who could benefit from it.

As such, we brought the full field team together during the quarter to focus on 3 key areas for the second phase of our launch. We refined our target list of healthcare professionals so that we can efficiently call on prescribers who are treating the majority in PNH patients.

We further evolved our partnerships with key centers, and we realized our field structure, including the addition of new team members. We deployed the expanded field force in September, and they are now fully engaging with the PNH community.

Separately, as a reminder, our sNDA with the Phase III PRINCE results and the 48-week Phase III PEGASUS data has a PDUFA date in February 2023. If approved by the FDA, this will allow us to further strengthen our promotion of EMPAVELI for treatment-naive patients and raise greater awareness of our long-term efficacy and safety data.

Let me now turn the call over to Fede..

Thanks, Adam. Good afternoon, everyone. In August, we announced our longer-term 24-month results with pegcetacoplan and had the opportunity to share this data at multiple ophthalmology congresses this four [ph]. The medical team has been engaging with hundreds of renting specialists over these past few months.

Like Adam said, the feedback on the data has been outstanding, and the possibility of having them in the label of launch has been very well received.

Results at 24 months showed 2 highly consistent studies demonstrating that treatment with pegcetacoplan resulted in increased effects over time with greater reductions in initial growth from baseline to month 24. These effects were observed across both the every-month and monthly treatment arms.

Then if you look at the combined data from DERBY and OAKS, pegcetacoplan treatment showed an acceleration in the reduction in invision growth, specifically between month 18 and 24. With reductions increasing to 24% and 30% in the every other month and monthly arms, respectively, the potential magnitude of benefit for patients could be substantial.

Within the same 18- to 24-month period, pegcetacoplan also appeared to be equally effective across both non-subfoveal and subfoveal lesions in both treatment arms. Importantly, we continue to see a favorable safety profile consistent with what we saw at 12 and 18 months.

Safety data has now been collected over 2 years in over 1,200 patients and nearly 12,000 injections. Turning briefly to our systemic pipeline. We are continuing to advance our disease franchise to deliver on the broad platform of EMPAVELI, which includes 4 later-stage studies in multiple complement-driven diseases.

A Phase III study with pegcetacoplan n in IC-MPGN and C3G and the Phase II study in HSTC-TMA are both Apellis rolling patients. In October, our partner Sobi announced the dosing of its first patient in the first 3 study in cold agglutinin disease or CAD.

And finally, we remain on track to report the top-line results from our potentially registrational Phase II study in ALS in mid-2023. Let me now turn the call over to Tim for a review of the financials.

Tim?.

Thank you, Fede. Since we issued a press release earlier today with the full financial results, I will just focus on the highlights for the third quarter 2022 summarized here. As you can see, total revenue was $22.1 million, which consisted of $17.7 million in EMPAVELI net product revenue and $4.4 million in collaboration revenue from Sobi.

R&D expenses were $95.2 million and G&A expenses were $78.4 million, and we reported a net loss of $191.3 million. As of September 30th, 2022, Apellis had $708.6 million in cash, cash equivalents, and short-term marketable securities.

Even with this shift in launch timing, we continue to expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing launch of EMPAVELI, the potential global launch of pegcetacoplan in GA and further development of our pipeline.

We remain confident in Apellis’ financial future as we continue to execute on our upcoming milestones. And with that, I will now turn the call back over to Cedric for closing remarks.

Cedric?.

Thank you, Tim. This is an incredibly important time for our company. Our position in the PNH market is expanding.

We are close to having a second commercial product available that we believe can have a life-changing impact on people's lives, and we continue to advance a robust pipeline, encompassing multiple late-stage rare disease programs as well as preclinical programs heading into the clinic.

We are on track to achieving our vision of being the global leader in compliment. And let us now open the call for questions.

Operator?.

[Operator Instructions] Madhu Kumar of Goldman Sachs..

This is Rob on for Madhu.

First, what's the time frame for submitting the 24-month data to the FDA? And how long after the submission, should we expect to wait for clarity on the PDUFA date and if Natomas [ph] still necessary?.

Thank you so much, Rob, for that question. So we -- in our discussions with the FDA, again, this is classified as an unsolicited submission or amendment. We agreed with the FDA that if this was submitted before the current PDUFA date that we would get in new PDUFA that would be sometime in the latter part of February.

So that is where we currently step..

Our next question comes from Tazeen Ahmad of BAML..

Cedric, I was wondering if you could share any of the feedback that you might have gotten this weekend. I know that you attended the Retina Society, meeting since the press release was put out in time for you to talk about it there.

Just wondering what reaction you got from physicians when you mentioned that you would be applying now to have 24-month data in the label.

And then secondly, for the J-code, if your PDUFA date does get pushed to February, when should we expect to see the permanent J-code when you launch?.

Thank you, Tazeen. On the feedback from the doctors, I will hand it over to Federico, who was there with me as well, but it was overwhelmingly positive. And again, we are doing this for the benefit of physicians and patients. And Fede, maybe you can elaborate a little bit..

Yes. The feedback was very positive this week and with this disease, like geographic atrophy, having understanding the effects over time, it’s highly valuable, and physicians understand that, and we really welcome our decision and the possibility of having all our data at 24 months in the label to start with..

And then for your second question, Tazeen, on the J-code. So we expect to have the J code early October..

Jon Miller of Evercore..

I have a question. Have you been in labelling discussions yet with the FDA? And if so, how is that being impacted by 24 months data? And then secondly, previously, you had mentioned that the agency was treating 18 months data as primary just the trials were designed for 12 months as primary.

Do you anticipate the FDA would instead treat 24-month data as primary now? And how does that work statistically given the trial wasn’t prespecified at the later time?.

Thank you so much, Jon. So our discussions on this amendment preempted the label discussions with the FDA. So to be clear about that. But again, it was a very productive back-and-forth interaction as it relates to the primary endpoint.

So we will have to see -- I mean, this is, of course, something that we hope based on the language that we had before, may indeed apply. But that's, of course, the decision from the agency..

I understand. Separately, did the FDA ever bring up questions around the microperimetry data in any of your earlier discussions, I asked because, obviously, that is another important difference between 18 and 24-month data..

Yes. Thank you, Jon. So we were very excited about, as you may recall, looking at the microperimetry around the actual lesion size where we had a signal for a functional impact of the treatment.

But to be clear, the primary endpoint and every efficacy consideration with the FDA was and continues to be showing that we can anatomically reduce the growth of the lesion in these patients..

Anupam Rama of JPMorgan..

I thought maybe I’d throw the one PNH question that might get asked on this call. On the SNDA for EMPAVELI, just wondering what your market research suggests about how including those data from the PRINCE study might change the ramp curve and the phenotype of the patient -- the PNH patient that is treatment naïve that might initiate therapy..

Thanks, Anupam. I'm going to hand that one over to Adam..

Thanks, yes. So obviously, the team is thrilled with the progress on the EMPAVELI launch as we go into Phase II. So the supplemental NDA with the Phase III PRINCE data just allows us to have even more robust conversations with the physicians about treatment-I patients and the benefit of switching to EMPAVELI.

So at the moment, we have about 10% of our patients are actually treatment-I patients. And we expect that having a much more detailed conversation and the update on the label will allow us to remind people that EMPAVELI is the product of choice.

So the field-based team is super excited to have that potentially in the label, and I think we’ll see some really strong progress there..

Philip Nadeau of Cowen..

One question that we get all the time, Cedric is on pegcetacoplan in the filing is whether the filing was in any way in response to a proposed label where maybe there are some elements that you didn’t like.

I know you just said that you weren’t action labelling negotiations, but have you seen any proposed label from the FDA? That’s the first question. And then second question, during the prepared remarks, you mentioned that the 24-month data would broaden have doctors think about using pegcetacoplan.

Can you elaborate on that? In what ways will the 24-month data change how physicians could use the drug?.

Okay. Thank you, Phil. So as I mentioned earlier, so we went to the FDA with this proposed amendment, this preempted the label discussions. So we propose that we wanted to include the full 24-month data. The FDA agreed with that.

So it's important to point out that after our agreements, we actually did run the press release that we issued on the subject via the agency to make sure that we were in full alignment. And so this is the path that we chose, which we believe will be in the best interest of patients and physicians.

And Adam, why don't you tell us why that is important?.

Yes, absolutely. So thank you, Phil. So obviously, the team and the whole of Apellis is actually excited about the 24-month data, particularly the efficacy increasing over time, more consistency between our 2 studies and the robust safety. So one thing that we’ve done is we’ve tested with retina specialists in the U.S. and ex-U.S.

at 12 months and 18 months and not 24 months. And not a surprise in our market research, the profile of the drug improved in their perception.

And 24 months, we got comments from retina specialists about how they are much more comfortable about talking to a broader set of patients based on the efficacy profile of the drug and the consistency between the 2 studies.

So I expect as we continue to do disease-state education and to launch that will have -- physicians will have a much easier conversations with their patients. And I would expect them to bring more patients into that discussion as a result of the strong efficacy data there..

Yes. And just think about it this way, the therapy rep, the trial that just a year ago, ran into the issues that we're all familiar with and the piece-wise linear analysis from out 18 to 24 on the monthly patients for the slope has a 36% slowdown in the growth and 29% for every other month. So these are just really important data for us.

Again, that's an important effect between month 18 and 24 generate, that consistency at 24 months between the 2 studies, and that is something that we find particularly important..

Steven Seedhouse of Raymond James..

Just Cedric, I wanted to go back to a comment you just made about running the press release by the agency to make sure you’re on full alignment. Why did you even need to give a press release last week since this was an elective decision on your part instance, as far as we can tell as of today, you still haven’t submitted the 24-month data.

I mean, why not just announce that with earnings? I’m curious what prompted the press release in the first place..

Yes. Thank you, Steve. Retina Society. So we do this for physicians and patients, and the Retinal Society is really the last important conference of the year. After this one, angiogenesis, I'd say, would be the next one, which is already in February. So we wanted to have the opportunity to really speak openly about this with the Retina community..

Got it. Okay.

And then how much did competitive dynamics specifically play into this decision? So anticipating a potential competitor in Iveric being on market next year and how that might have changed or evolved your view of the label and how that's going to position competitively? And then also how much did AAO and the feedback you got there from physicians play into this decision?.

So look, we are -- we believe that we have a very exciting product profile at 24 months that we can bring to physicians that they can then communicate to patients. And of course, we believe that positions us well competitively. So these are decisions that are never unique colored. Many factors go into it. Competition is just a small part of that.

But we wish our competitors the best of luck, as well as they, move forward towards….

Just lastly.

Are you -- without this amendment, would you have anticipated both the foveal subgroup and every other month dosing in the label regardless? Or does this specifically enhance the probability of both of those being included in the label?.

The answer to that is yes. And as it relates to AO. So look at the American Academy of Ophthalmology, we -- as you may recall, in the month of September, we did the whole analysis to really better understand what the functional impact was of these treatments, which, as you know, because these measurements are so complicated, can be difficult to do.

So at AAO, we had a very setting data on the microperimetry. But in the meantime, I think a little bit lost in the noise, quite frankly, was how good the 24-month data really was. And again, something that we believe we want to hire society [ph], it was a great opportunity to do that again, and we look forward to continuing that in the next year..

Chris Howerton of Jefferies..

I guess the first one I had was with respect to the 24-month data.

If you guys could comment on the relative importance of those data being in the label itself versus a high-quality peer-reviewed journal article? And then the second question is maybe just a clarification, Cedric, in terms of how does the conversations change at the Retina Society because wouldn’t they have already known the 24-month data, and it’s really just their perception of it being in the label or another venue? So just help us understand the rationale there specifically..

Thank you, Chris. I'm going to hand it over first to Adam to talk about the label versus article and white label is important to us..

Yes. Thanks, Chris. Good to talk to you. So obviously, we have 100 field-based employees out there talking about disease day education. And they’re going to be our most important voice as we get a potential approval. And the label in my experience, is the most important document that we could ever have at Apellis.

It allows those field-based teams to have a really robust conversation based on the label language with physicians. So I think that’s a critical mass for us here. We’re going to make sure that those conversations are as robust as possible.

And that’s our quickest and most nimble way of getting the data out there to the 2,600 retina doctors that we will target. Obviously, a publication of the data also supports that we can move very quickly post-approval to have those conversations live with physicians. And that’s our priority..

Thank you, Adam. And then for the Retina Society. It was great cumbersome. Fede, maybe you want to elaborate a little bit on that..

So basically, the conversation changes at the Retina Society based on the 24 months, the implication there was that for the doctors, they know the data, but the ability to have a simplified message towards their patients for these retina doctors is important. And it’s important to point out as well that at Retina Society have the KOLs.

But if you talk about the doctors that are actually practicing in rural America and all the places where we need to go as well and transmit the message, there it will be incrementally important to have this available to us..

Colleen Kusy of Baird..

Can you comment on how you receive the feedback from the FDA on the alignment for the 24-month inclusion? Was that writing? And how likely do you think it is that the FDA will accept the amendment? And then just given the especially short timelines of the original timeline for your NDA review, do you have a sense of if the empty review was tracking to schedule prior to this amendment?.

Thank you, Colleen. So first of all, with respect to the first question, this was a verbal conversation with e-mail feedback specifically on the press release that I mentioned earlier. So this was a very smooth process, to be honest with you.

And we expect there to be no issues in the weeks to come, where we will submit and when we will get into a new PDUFA date.

So then the second question, sorry Colleen, because you were a bit careful, it was on review tracking?.

Yes.

Just do you have a sense of if the -- if the NDA review was tracking to schedule prior to this amendment?.

Yes, it was. So it's worth mentioning here, Colleen, again, that this was a very concentrated review timeline. So we had a priority review, but a priority for Type 3 NDA submission, which meant, as you know, 6 months from the time of submission. So everything has to be increased into a very short timeline between the end of July and now.

And that was, as I mentioned before, a very smooth process with then in yet the decision that we decided to file this amendment..

That’s helpful. And one quick follow-up.

Does this change at all your thoughts on the likelihood of the FDA hosting an advisory committee meeting?.

It does not. So there was no mention or discussion of an ADCOM [ph]..

Justin Kim of Oppenheimer..

Maybe just taking a step back and thinking about the landscape with some recent and upcoming data updates for systemic applications of compliment.

Just curious if the team had any updated thinking on targeting IgA Nephropathy, perhaps with earlier-stage modalities such as an oral Factor B? And any of the implications of some of the siRNA combo data that’s upcoming at ASH as you think about getting into clinic also next year?.

Thank you so much, Justin. So as you know, IgA property is not a focal point for us. Right now, our nephrology programs are set globality and immune complexes [indiscernible] arthritis. The ASH is intriguing with the Apellis [ph], of course, and we continue to look at that.

I think it's a further testament to the broad potential that consumers can control has across a wide range of therapeutic areas. And the siRNA, that's another program that we are very excited about and where we are now nearing up on NDA in the near future..

Yigal Nochomovitz of Citi..

So I just wanted to follow up.

Could you just elaborate a little bit in terms of what specifically happened internally at Apellis that enabled your regulatory team to apparently accelerate the preparation of the full 24-month data, which obviously enabled you to move faster with the timelines, as I understand, which then triggered a chain reaction, which allows you to have more time to submit the 24-month data now? As I think if I'm correct, the original expectation is that you would not be able to move quite as quickly as you ended up moving with the preparation of the 24-month data.

If you could just help me sort that out, that would be great..

Thank you, Yigal. So it was a combination of multiple factors, as we outlined in the script. But on one hand, the launch timelines, which changed and which were planned for the beginning of January, the first 2 weeks, more or less.

And then as you mentioned, the fact that at least in September, we did not want to prioritize the filing of an amendment over the preparation of the European filing. But all these things, of course, go in hand in hand with each other.

The finding of Europe moved forward very well and very quickly and the possibility of doing an amendment without hurting that efforts became clear. So when we realized that the only penalty to pay here was plus or minus a few weeks, 6 weeks on the current plans for the launch without a delay on the J-code and the possibility to file that amendment.

That was a strong message for us, of course, combined with the fact that our commercial team in the meantime is working very hard and considered this to be very important..

Okay. Got it. That makes a lot of sense. And then maybe just to help everyone who’s less familiar with the J-code process.

Can you just explain specifically what’s the reason why that 6- to 7-week delay between starting on January 1st versus starting the launch on end of Feb doesn’t impact the timeline to getting the full permanent J-code by October? Just can you just walk through the reason why that doesn’t matter?.

Yes. Thank you, Yigal. That's a great question. So essentially, permanent J-codes get issued by quarter. And so to get the supply logistics in place and be there on time to ship your first trial is what drives that.

And that is what led us to realize over the past month or 2 months that a likelihood at the beginning of October was going to be the permanent J-code for us. And in that context, launching in the first half of January or the second half of February does not make an impact or a difference for the J-code..

Ellie Merle of UBS..

Just after all the interactions with the FDA, can you just speak to your confidence that GA lesion growth is still considered an approvable endpoint? I guess any reason to think that the FDA or someone within the FDA, even perhaps higher than Wiley Chambers, might be questioning the clinical meaningfulness or expressing any doubt.

And then just in terms of like the approval itself, I guess who at the FDA signs the ultimate approval? Is it with Wiley Chambers and the ophthalmology division or could it become somewhat higher?.

Thank you, Ellie. So as far as we know, nothing has changed. So there has never been a mention at all that there is a change in the approvability or the process and how lesion growth is the primary endpoint. So that is absolutely not something that I think anyone should be concerned about.

So then the approval process, I believe, getting on the border of how I understand the regulatory process to be. But at the end of the day, the division makes the determination that Dr. Chambers [ph] signs off on it.

And I believe that there is a further sign of higher in the FDA, but I don't think that, that is typically a place where problems emerge to speak of it that way..

Annabel Samimy of Stifel..

I touched on a little bit before.

But can you just help us understand whether the FDA is going to be reviewing the 24-month data with any statistical rigor as it is the 18-month data, which accepted, I guess, is the primary endpoint? Or is it just going to be reviewed for informative purposes and then placed on the label for information so you can talk about it? I guess if that’s the case [indiscernible].

So I’ll just wait for a publication because it seems like a lot of the physicians know the date already. They’ve seen it multiple times now. So I just want to understand how FDA is going to be looking at this data versus the other data that you’ve already submitted..

Thank you, Annabel. Yes, of course, we are hopeful that, that language that we got at 18 months makes us hopeful that the 24 months may need be considered the primary endpoint. So that in combination with the strength of the data. And again, I cannot overemphasize how powerful that increased effect over time is.

You're talking about getting into the ZIP code of 30%, that's extraordinary. The fact that it increases the longer you treat these patients, is a really important message and creates a lot of hope. And remember, at least for now, I think we should all hope that, that continues to go beyond year 2 as well.

The reason why this is the primary endpoints with the FDA is that this is not a disease of 2 or 1 years. This is a disease where patients are affected for 5 or 10 years, sometimes decades. And the long-term impact of this disease is terrible, and we're hoping to mitigate that.

So just to follow up on that, are these -- I guess, are these patients?.

Just to follow-up on that. Let me just step back. How often does the FDA just change the endpoint? I mean, I guess that’s the question. They went from 12 months to 18 months to 24 months. So is the statistical rigor as intense at 24 months as it was, was it 18 months as it was at 12 months? I guess that’s another way of asking the question..

All we know Annabel is the communications that we get from the FDA. So we don't write those rules, and we go along with them. So that is that's all I can say..

Joey Stringer of Needham..

This is Chen [ph] for Joey. So our first question is, what is your current thinking on any potential partners should either in the U.S. or ex-U.S. or exit of coal plant in GA? And our second question is, could you help frame expectations for tax core [ph] plan Phase II ALS study next year.

So what you see clinical meaningfulness on the AFS primary endpoint? And would this trial potentially be consider registrational?.

Thank you, Joey. So on partnerships in geographic atrophy, we are and have been preparing to launch this product ourselves in the U.S. as well as ex-U.S. So that has been our plan and continues to be our plan. As it relates to the ALS study, this is, of course, a high-risk, high-reward study.

So the likelihood of meeting the primary endpoint in that study, like all ALS studies is going to be low. But should we meet it, of course, it would be of high clinical and human meaningfulness for the company and for patients..

Douglas Tsao of H.C. Wainwright..

A lot of my questions have been answered. But just curious, in terms of the Retina Society meeting, I’m just curious in terms of feedback you got from physicians, what was it that the most were impressed by the 24-month data? Was it safety? Was it efficacy? Was it the acceleration? Was it — I’m just curious in terms of the feedback.

What -- or maybe said a different way, what about it, did the 24-month data, due to change their perception that they already didn’t think from the 18-month data?.

Thank you for that question, Doug because, honestly, this is why we did it. The data between 18 and 24 is absolutely remarkable and the ground-breaking in the retina. We are starting to understand how this drug works in this disease.

We're seeing that with those increased effects over time, again, getting into that discos of 30% slowdown, 30%, by the end phase of those 2 years, which is incredibly important for these patients. We also are starting to see the functional impact on these microperimetry analysis that we run. So all these things are important.

And last but not least, of course, something that was first presented at AAO, where on the OCT images in these patients, we can also specifically look at the rate at which photoreceptor cells are lost. It's really honing on these cells that detect the vision in the retina and where we have extraordinary results as well.

So all of that was very positive and important and we are starting to really understand how this direct works, and we look forward through this major amendment to being able to talk about many of these things and the label with the border community..

And maybe just as a quick follow-up, Cedric, all those points, what was -- was there anything that really captured the imagination of the physicians at the Retina Society meeting?.

Yes. So I would say we've captured most of their imagination in the discussions that we had was the work that was done. This gets a little bit technical, but the work that was done by our collaborator, Lucerastat Air Force in Austria, where again, looking at these OCT images, she looked at the photoreceptor cell loss specifically.

So not the supportive still that you have in the retina. And there, in this blinded analysis that we did, after 1-year time points, both in DERBY as well as in OAKS, we had as much as approximately 75% saving of photoreceptor cells. So work that requires more to be done, of course.

But I think that Retina [ph] looking at that and understanding how the mechanism works is very helpful. And Adam would like to add something to that as well..

Yes. Doug, I just thought it would be interesting for you. You’re asking about the Retina Society meeting, but also our 24-month data market research. I’ll summarize the overall feedback from the market research, which is with retina specialists, key opinion leaders as well as those that potentially don’t go to those type of meetings.

At 24 months, there was a really strong conviction towards the therapeutic effect. And DERBY’s near miss at month 12 became irrelevant to those physicians that we used within the market research. From an efficacy perspective, they were impressed by the longevity and the consistency of the efficacy curve of separation across both studies.

And they start to really appreciate the robustness of the clinical data. And we continue to get quotes during that market research, such as its impressive that the effect of treatment is increasing with time. It’s just really impressive. We kept getting that impressive word was the one that came out.

The effect was already proven after 6 months, but we’re speaking about reductions of about 30% after 24 months. That type of feedback we consistently got from our 24-month market research..

Our last question comes from Madhu Kumar of Goldman Sachs..

It's Rob on again.

Just one other question we had was, is there any impact from the IR, the inflation Reduction Act and moving the approval potentially back to 2023?.

Thank you, Rob. You’re double dipping here. I like that. No. So this was not a consideration in our decision-making process. And look, it’s understandable that this comes late. It generates confusion. But when the circumstances are there and they always evolve and they’re never one circumstance, but several things.

When we get to a point where we truly believe that it’s going to be better for patients and for physicians. Sometimes you have to make difficult choices. And doing it now close to the PDUFA is not ideal, but we believe it’s going to be serving us very well as the next year comes. So thank you for your question.

And is there anybody else after you, Operator?.

That's all. That concludes our Q&A..

Thank you so much. So in closing, thank you all for joining us today. We are around later today and tomorrow. And if you have any additional questions, please feel free to reach out to Meredith..

Thank you for your participation in today's conference. This concludes the program. You may now disconnect..