Q2 2022 Apellis Pharmaceuticals Inc Earnings Call

August 8, 2022

Ladies and gentlemen, thank you for standing by and welcome to the Apellis Pharmaceuticals second quarter 2022 earnings call.

Well, ladies and gentlemen, thank you for standing by and welcome to the Euro.

At this time, all participants are in a listen-only mode.

So we're going to look at what we get from the study and, in addition to that, all the natural history data to find the relationship between the functional endpoints, sorry, between the anatomical endpoints and function that may not necessarily come from central visual acuity, which is hard to measure.

Second quarter 2022 earnings call at this time, all participants are in a listen only mode.

After the speaker's presentation, there will be a question and answer session.

After the Speakers' presentation there'll be a question and answer session to ask a question during the session need to press star one on your telephone I would now like to turn the call over to your host Meredith Kaya you may begin.

To ask a question during the session, you need to press star 11 on your telephone.

I would now like to turn the call over to your host, Meredith Kaya.

So we're going to be doing a little more investigation on the data in the study to see what correlations we get.

You may begin.

Okay, thanks.

Good afternoon, and thank you for joining us to discuss the second quarter 2022 financial results with me on the call our co founder and Chief Executive Officer, Dr. Cedric Francois Chief Commercial Officer, Adam Townsend, Chief Medical Officer, Dr. Federico Gretzky and Chief Financial Officer.

Good afternoon and thank you for joining us to discuss Apellis's second quarter, financial results.

And then, Adam, could you just tell us, if you could, what percent of the PNH market you believe you've captured so far in the U.S.?

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 on slide three 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.

Tim Sullivan.

Before we begin I would like to point out on slide three we will be making forward looking statements that are based on our current expectations and beliefs. These.

I encourage you to consult the risk factors discussed in our SEC filings for additional detail.

<unk> 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 Patrick.

Now, I'll turn the call over to Cedric.

Thank you all for joining us today.

Yes.

Thank you all for joining us today.

2022 is a transformational year at Applebee's.

2022 is a transformational year at Apellis, and we are making great progress across each of our key priorities.

So, thanks, Miguel.

And we are making great progress across each of our key priorities.

I'll start with geographic atrophy, or GA. A few weeks ago, we were thrilled to announce, that our NDA for intravitryl pexitacoplan was accepted by the FDA with a priority review designation and a PDUFA date of November 26, 2022.

So, obviously, we think there are 1,585 treated patients, and we have over 200 start for approximately 190 to 200 start forms.

I'll start with geographic atrophy or <unk>.

A few weeks ago, we were thrilled to announce that our NDA for <unk> was accepted by the FDA with a priority review designation and a <unk> of November 2006 2022.

So that should give you a good hint of how, of the progress that we're making as we go.

The FDA also stated that it is not planning to hold an advisory committee meeting to discuss the application.

This is the best outcome, we could have hoped for and I am so proud of the <unk> team for their efforts in getting us to this pivotal point.

This is the best outcome we could have hoped for, and I am so proud of the Apellis team for their efforts in getting us to this pivotal point.

The NDA includes all available data from our Derby and Oakes studies out to 18 months, and in the case of some patients, even longer, as well as the 12-month data from our Philly study.

The NDA includes all available data from our Derby and Oaks studies out to 18 months and in the case of some patients even longer as well as the 12 month data from our <unk> study.

Collectively, these data reinforce the potential for pexitacoplan to meaningfully slow disease progression and become the first-ever treatment for the millions of patients living with GA, a relentless disease that is a leading cause of blindness worldwide.

Collectively these data reinforce the potential for Pepsi that group them to meaningfully slow disease progression and become the first ever treatment for the millions of patients living with GE.

A relentless disease that is a leading cause of blindness worldwide.

We continue to work with the agency in our efforts to bring this therapy to patients, who currently have no approved treatments.

We continue to work with the agency and our efforts to bring this therapy to patients who currently have no approved treatments.

In parallel, we are also ramping up our commercial preparations so that we are well-positioned to bring intravitryl pexitacoplan to patients immediately upon potential approval.

In parallel we are also ramping up our commercial preparations. So that we are well positioned to bring in <unk> opex at that group them to patients immediately upon potential approval.

In Europe, we are on track to submit our application to the EMEA by the end of this year.

In Europe , we are on track to submit our application to the EMEA by the end of this year.

We will include the 24-month data from Derby and Oakes in our, submission, which we plan to report in September.

We'll include the 24 month data from Derby and Oaks in our submission, which we plan to report in September .

J.D.

J D will speak to this EBIT more in a few minutes.

will speak to this a bit more in a few minutes.

Turning to <unk>, we remain focused on further establishing impact at this first line treatment for patients living with <unk>.

We obviously don't give guidance on revenue or anything along those lines, but with over 200 REM-certified physicians and start forms continue to come in, we think we're really making good progress in converting C5 patients and starting treatment in naive patients within PNH.

We are seeing continued strength across a number of key indicators.

Okay, thank you.

Translating to $15 $7 million in U S net revenues for the second quarter.

Turning to PNH, we remain focused on further establishing empathy as a first-line treatment, for patients living with PNH.

One moment for our next question.

Globally, our partner <unk> is also making progress in bringing <unk> to patients with <unk> outside of the U S.

Our next question comes from Ellie Merle with UBS.

Beyond <unk>, we continue to advance <unk> as a transformative therapy for rare complements driven diseases.

Your line is open.

Hey, guys.

Together with <unk> we.

Now Thats for later stage clinical programs underway.

Thanks so much for taking the question.

We are also continuing to progress our early stage pipeline with <unk>.

Just first on the ION, can you just elaborate on the cases that were seen, I guess, how the patients presented and how they were managed and, I guess, if it was resolved?

<unk> planned for APL 2006, and our SA RNA program in the first half of next year.

We have made great progress in our partnership with beam, hence with our efforts to advance complement inhibition as a novel approach to enhancing <unk> associated viruses or Z based gene therapy products.

We are also continuing to advance our preclinical work with APL 10, 30 for potential use in neuro degenerative diseases, but no longer expect to submit the IND by the end of 2022.

We are seeing continued strength across a number of key indicators, translating to $15.7 million in U.S. net revenues for the second quarter.

And then also specifically, I think, in one of the first questions on the call, you mentioned some comorbidities that the patients had.

On the finance side.

We ended the second quarter with approximately $850 million in cash providing runway into the first quarter of 2024.

Globally, our partner Sobe is also making progress in bringing empathy to patients with PNH outside of, Beyond PNH, we continue to advance EmpatheD as a transformative therapy for rare, complement-driven diseases.

Together with SOBE, we now have four later-stage clinical programs underway.

We are also continuing to progress our early-stage pipeline, with INDs planned for APL 2006 and, our siRNA program in the first half of next year.

This puts us in a uniquely strong position in this challenging market environment as we head into a potential launch later this year.

We have made great progress in our partnership with BEAM and with our efforts to advance, complement inhibition as a novel approach to enhancing adeno-associated viruses or AAV-based gene therapy products.

We are also continuing to advance our preclinical work with APL 1030 for potential use in neurodegenerative, diseases, but no longer expect to submit the IND by the end of 2022.

We look forward to building on our momentum as we further cements our position as a leader in complements across multiple therapeutic areas.

On the finance side, we ended the second quarter with approximately $850 million in cash, providing, runway into the first quarter of 2024.

If you could just kind of elaborate on this and maybe why this sort of leads you to think that this was not drug-related in those cases seen.

And with that I will turn it over to Adam.

This puts us in a uniquely strong position in this challenging market environment as, we head into a potential launch later this year.

And then just second question, just in terms of thinking about the real-world potential duration of use of anti-VEGFs in the cases of sort of new-onset exudations.

Thank you Cedric.

Maybe just, you know, how you're thinking about that and, you know, how long anti-VEGFs might be used in those cases.

Thanks.

And, I guess, if there's any data that we can expect, such as from the 24-month data or, you know, in thinking about sort of the longer-term Yale study about sort of the management of the new-onset exudations and thinking about the duration of use of the anti-VEGF.

Turning to slide five we are now in our second year of commercial MTV Olly in the us.

Cedric mentioned the commercial launch remains strong.

In the first year, we focused our efforts on the patients with the highest unmet need who are the one third of patients on <unk> inhibitors, who require transfusions to address their falling hemoglobin levels.

We are continuing to see positive trends across the key leading indicators.

In the second quarter, approximately 30 start forms which generated <unk>.

The total number of start forms since launch to approximately 190.

Over 75% of C. Five inhibitor patient switches are continuing to come from Altamira.

Over 35, additional physicians, who are rems certified bringing the total since launch to greater than 200, we continue to see strong rems certification growth, which continues to be a key leading indicator as we move into the second year of launch.

Patient compliance rates remained high at 95% and we have established strong formulary access amongst the top 20 pads.

Thank you, Ellie.

Now in the second Yeah, we are heading into the next phase of our commercial strategy.

Which is expanding our focus to the broader pnas community by further positioning <unk> as.

First line treatment for all patients with ph.

Our refining our physician targeting so that we efficiently call on those prescribers, who are treating the majority of <unk> patients.

We are also advancing our outreach to key thought leaders.

Especially now that Doctor Hillman is fully on boarded.

In this next phase of launch we will have all of our partnerships with new centers to drive additional prescribers.

Pure that patients with <unk> have access to empirically.

Additionally.

NDA, including the phase III <unk> results and the 48 week Phase III Pegasus data was accepted with a <unk> date in February 2023.

If approved by the FDA this will allow us to strengthen our promotion of empathy for treatment nave patients and raise more awareness of our longer term efficacy and safety data.

So, on the IOM cases, you know, the details is not something we're going to talk about on this call.

Now turning our attention to our progress MGA on slide six.

We are excited to be even closer to our anticipated approval and commercial launch in this critical area of high unmet need.

I think the first and important point was to find out if these SAEs, you know, were becoming worse over time, right?

I mean, we had one from 6 to 12 and then two from 12 to 18.

You know, there was, of course, I think a rightful consideration, is this going to become worse or not?

GI impact 5 million people worldwide, including 1 million people in the U S and I expect that the first approved therapy for this devastating disease may uncover even more patients.

And it didn't, right?

Here at the palace, we are compelled by the potential to bring the first ever treatment to patients as quickly as possible and excited by the Fda's decision to grant <unk> trio <unk> Copeland a priority review designation.

So, we didn't have a single additional case.

We are eagerly awaiting on November Paducah date, and our team is focused on ensuring that we are well positioned for the launch we are ramping up our commercial capabilities with a key U S leadership positions already in place as well as additional key positions globally and much of the U S.

Field force is starting imminently.

Our focus prior to approval is on disease state awareness, specifically within the retinal community and amongst some of the broader <unk> groups.

We are also advancing payer engagement to help us to secure a strong reimbursement and access post approval.

And we have established a retina advisory Council made up of several global opinion leaders to provide insights and advice as we prepare to bring <unk> to the market.

At launch our initial focus will be on the top 2600, retinal specialists and injecting ophthalmologists in the U S.

These physicians in managing the vast majority of Gi patients currently.

We will expand our assets overtime to activating additional referral pathways to ensure that patients are being referred to the right physician for treatment consideration.

We look forward to building on our momentum as we further cement our position as a leadering, complement across multiple therapeutic areas.

We look forward to providing more granular details on launch preparation and execution as we closer to our Paducah date.

And with that, I will turn it over to Adam.

Let me now turn the call over to F&I.

Thank you, Cedric.

Thank you Adam.

Turning to slide five, we are now in our second year of commercial empivelli in the U.S., and as Cedric mentioned, the commercial launch remains strong.

We are continuing to see positive trends across the key leading indicators.

Now, as it relates to the real-world evidence for the new-onset exudations, the Derby and Oak studies, when patients have new-onset exudations, they get treated with anti-VEGF on regular pathology.

In the first year, we focused our efforts on the patients with the highest unmet need, who are the one-third of patients on C5 inhibitors who require transfusions to address their falling hemoglobin levels.

The data from our <unk> studies continue to underscore the significant potential of our seafood complement approach.

In the second quarter, approximately 30 start forms were generated, bringing the total number, of start forms since launch to approximately 190.

Over 75% of C5 inhibitor patient switches are continuing to come from Ultimiris.

Over 35 additional physicians were REM certified, bringing the total since launch to greater, than 200. We continue to see strong REM certification growth, which continues to be a key leading, indicator as we move into the second year of launch.

Patient compliance rates remain high at 95%, and we have established strong formulary access, amongst the top 20 payers.

At the end of the two-year time period, we have one PRN step.

Following the 18 month data reported in March we have shared additional analysis at key retina meetings.

Now in the second year, we are heading into the next phase of our commercial strategy, which is expanding our focus to the broader P&H community by further positioning empivelli as first-line treatment for all patients with P&H. We are refining our physician targeting so that we efficiently call on those prescribers, who are treating the majority of P&H patients.

We are also advancing our outreach to key thought leaders, especially now that Dr. Hillman, is fully on board.

Does that mean people stop receiving anti-VEGF?

Additionally, our SNDA, including the Phase III PRINCE results and the 48-week Phase III, Pegasus data, was accepted with a PDUFA date in February 2023.

In this next phase of launch, we will evolve our partnerships with new centers to drive, additional prescribers and ensure that patients with PNH have access to EmpaVeli.

Reinforcing that treatment with both monthly and every other month interim each opex at the Copeland and these studies demonstrated a clinically meaningful reduction in Gi lesion growth with a favorable safety profile.

As approved by the FDA, this will allow us to strengthen our promotion of EmpaVeli for, treatment-naive patients and raise more awareness of our long-term efficacy and safety data.

And then we find out, how long does it take for these patients to leak again?

And we compare that between active and the sham control.

As highlighted on slide seven at ARVO in May.

Center data showing that treatment with <unk> continued to demonstrate a robust effect in patients with extra for deletions and then improve the effect in patients with formulations as compared to what we observed in the 12 month results.

So, that's going to be an interesting piece of information on which we will have more information next year as well.

So, Gail is important there again to find out what that means, how dependent patients are going to be on anti-VEGF.

But I can tell you that in the studies, the combined administration of anti-VEGF and Plexus Acoban has not been an issue.

Great.

Thanks for the call.

Thank you.

We also had a strong presence at Macula Society in June .

One moment for our next question.

This included data showing consistent reductions in GAA lithium growth in treated eyes basis and treated cellulite.

Our next question comes from Annabelle Femi with CFL.

Your line is open.

The compound also demonstrated sustained reductions in Gi lithium growth across all subgroups defined by increasing the expenses from the <unk> Center.

And just last month at the Srs.

<unk> analysis from Derby, and Oaks that showed the mean weight or slope of GAA lesion growth at 18 months.

The results from this analysis were consistent what we have shown previously at 18 months.

We'd all nominal P values for both dosing regimens below zero point real quick.

Collectively all the data from Derby Oaks filly reinforced the potential opex at the top line to slow the progression of gea across the disease spectrum, which is critically important given the third gen. AP of these patient populations.

Now turning our attention to our progress in GA on slide 6, we are excited to be even, closer to our anticipated approval and commercial launch in this critical area of high unmet need. GA impacts 5 million people worldwide, including 1 million people in the U.S., and I expect, that the first approved therapy for this devastating disease may uncover even more patients.

Hi.

We're excited to potentially bring the first ever therapy to patients with <unk> with an opportunity to save as many photoreceptor cells as possible.

Here at Apellis, we are compelled by the potential to bring the first-ever treatment to patients, as quickly as possible and excited by the FDA's decision to grant intravitreal pexetocoplin a priority review designation.

Thanks for taking my question.

We are eagerly awaiting our November PDUFA date, and our team is focused on ensuring, that we are well-positioned for the launch. We are ramping up our commercial capabilities with the key U.S. leadership positions already, in place, as well as additional key positions globally, and much of the U.S. field force is starting imminently.

Our focus prior to approval is on disease state awareness, specifically within the retinal, community and among some of the broader eye care groups.

We are also advancing payer engagement to help us to secure strong reimbursement and, access post-approval, and we have established a retina advisory council made up of several global opinion leaders to provide insights and advice as we prepare to bring pexetocopin to the market.

At launch, our initial focus will be on the top 2,600 retinal specialists and injecting, ophthalmologists in the U.S. These physicians are managing the vast majority of GA patients currently.

The course of their disease.

We will expand our efforts over time to activating additional referral pathways to ensure that, GA patients are being referred to the right physician for treatment consideration.

So, I realize I'm possibly putting the cart before the horse, but, you know, you studied GA in a range of disease severities.

In September we plan to share top line results from Derby and Oaks at 24 months.

So, how do you envision approaching this market now?

As you May recall at 18 months, we presented full data showing that treatment with Brexit. The Copeland resulted in increased efficacy over each six months intervals.

It's clear from the data that the earlier the better, but clearly the most desperate are the patients at risk of losing sight and maybe getting relief benefits.

Six six to 12 and 12 to 18.

We look forward to providing more granular details on launch preparation and execution, as we get closer to our PDUFA date.

We look forward to evaluating whether this improvement continue between month 18.

Let me now turn the call over to Fede.

<unk> 24.

Thank you, Adam.

If confirmed it could mean that the longer patients are on treatment the better the response to the drug.

The data from our Derby and Oak studies continue to underscore the significant potential of, our C3 complement approach. Following the 18-month data reported in March, we have shared additional analysis at key, retina meetings. Reinforcing that treatment with both monthly and every other month intravitrol pexeta-Coupland, in these studies demonstrated a clinically meaningful reduction in GA lesion growth with a favorable safety profile.

As highlighted on slide seven at Arbo in May, we presented data showing that treatment with, intravitrol pexeta-Coupland continued to demonstrate a robust effect in patients with extra foveal lesions and an improved effect in patients with foveal lesions as compared to what we observed in the 12-month results.

We also had a strong presence at Macular Society in June. This included data showing consistent reductions in GA lesion growth in treated eyes versus, untreated cell eyes. Pexeta-Coupland also demonstrated sustained reductions in GA lesion growth across all, subgroups defined by increasing distances from the foveal center.

This good compound into very large nishu size reductions overtime.

And just last month at the ASRS, we shared analysis from Derby and Oakes that showed, the mean rate or slope of GA lesion growth at 18 months. The results from this analysis were consistent with what we have shown previously at 18 months, with all nominal p-values for both dosing regimens below 0.05.

Collectively, all the data from Derby, Oakes, and Philly reinforced the potential of pexeta-Coupland, to slow the progression of GA across the disease spectrum, which is critically important given the heterogeneity of this patient population.

Additionally, the secondary functional endpoints will be assessed at 24 months.

We're excited to potentially bring the first-ever therapy to patients with GA with an opportunity, to save as many photoreceptor cells as possible throughout the course of the disease.

JA progression is correlated with loss of visual function over long periods of time, meaning that reducing the rate of Gi lesion growth should eventually reduce the weight of vision loss.

In September, we plan to share top-line results from Derby and Oakes at 24 months. As you may recall, at 18 months, we presented pooled data showing that treatment with pexeta-Coupland, resulted in increased efficacy over each six-month interval, 0 to 6, 6 to 12, and 12 to 18. We look forward to evaluating whether these improvements continue between month 18 to, 24.

If confirmed, it could mean that the longer patients are on treatment, the better the, response to the drug. This could compound into very large lesion-size reductions over time.

Additionally, the secondary functional endpoints will be assessed at 24 months. GA progression is correlated with loss of visual function over long periods of time, meaning that reducing the rate of GA lesion growth should eventually reduce the rate of lesion loss.

As we have mentioned before, and as literature will suggest, we do not expect to detect a, difference between pexeta-Coupland and sham at 24 months due to the limitations of the functional endpoints and the relatively short period of time over which they are being assessed. We anticipate the separation to occur over longer periods of time.

As we have mentioned before an escalator Archer will suggest we do not expect to detect the difference between the top line and Sham at 24 months due to the limitations of the functional endpoints in a relatively short period of time.

Although which they are being asked that.

We anticipate the separation chaco over longer periods of time.

We will include this 24-month data in our MAA.

We will include this 24 month data and our MAA.

We have had productive discussions with the rapporteurs to date and are on track to submitting, to EMA by the end of 2022. The rapporteurs have shared with us that the EMA wants to understand the relationship between, preserving visual function and reductions in GA lesion growth.

We have had productive discussions with the <unk> to date and are on track to submit into EMEA by the end of 2022.

The porters have shared with us that the EMA wants to understand the relationship between preserving visual function and reductions in Gi lesion growth.

We're confident in our ability to show this based on published natural history studies, and data from our Phase III study.

We're confident in our ability to show these based on published natural history studies and data from our Phase III study.

Moving onto our pipeline on slide eight we're also working to deliver on the broad platform potential of <unk> to advance our rare disease franchise, which includes support later stage studies and multiple complement driven diseases.

Moving on to our pipeline on slide eight, we're also working to deliver on the broad, platform potential of Empavelic to advance a rare disease franchise, which includes four later-stage studies in multiple complement-driven diseases.

So, how are you initially going to be targeting this market as you enter the market?

I had a hard time hearing you.

One second.

In May, we dosed the first patient in a Phase III study with Paxetacoplan in immune complex, membranoproliferative glomerulonephritis, or ICMPGN, and C3 glomerulopathy, or C3G. We also learned that FDA granted orphan drug designation for Paxetacoplan for the treatment, of ICMPGN. This designation had previously been granted for Paxetacoplan for C3G.

Hello.

In May we dosed the first patient in our phase III study.

With box at the top line immune complex Membrana, Florida creative drama on a Friday or IC and PGM.

Okay.

C III gloom or ultimately or CPG.

Also learn that FDA granted orphan drug designation for Opex at the top line for the treatment of IC and PGM.

This is a nation has previously been granted corporates at the compound for CPG.

The Phase II study in hematopoietic stem cell transplant-associated thrombotic myocardiopathy, or HFCT-DMA, is actively enrolling patients.

The phase two study in hematopoietic stem cell transplant associated thrombotic microangiopathy or <unk> TMA is actively enrolling patients.

Our partner, Sobe, is currently screening patients in the Phase III study in collaglutin, immune disease, or CAD, and has guided to now dosing the first patient in the second half of 2022.

Our partner Saudi is currently screening patients in the phase III study in cold agglutinin disease, or <unk> and <unk>.

<unk> guided to now dosing the first patient in the second half of 2022.

And finally, we remain on track to report the top-line results of our potential registrational, Phase II study in MS in mid-2023.

And finally, we remain on track to report topline results from our part.

<unk> Registrational phase III study.

In mid 2023.

Let me now turn the call over to Tim for a review of the financials.

Sorry, Annabelle.

Let me now turn the call over to team for a review of the financial team.

Tim?

I had a hard time hearing you.

Tim.

Thank you, Fede.

Thank you.

Since we issued a press release earlier today with the full financial results, I will just, focus on the highlights for the second quarter of 2022, summarized here on slide 9. Total revenue was $16.3 million, which consisted of $15.7 million in Empaveli Net Product Revenue, and $0.6 million in collaboration revenue from Sobe.

But Tim, who has better hearing than me, just clarified it for me.

Since we issued a press release earlier today with the full financial results I will just focus on the highlights for the second quarter of 2022 summarized here on slide nine.

So, I think, again, one of the very exciting parts of our data set is that every other month, with half the number of injections, seems to give you close to probably 90% of the benefit in terms of slowing down the progression of geographic atrophy.

So, that fits very nicely with the product profile.

Total revenue was $16 3 million, which consisted of $15 7 million and <unk> net product revenue and $6 million in collaboration revenue from Tobey.

R&D expenses were $102 million, G&A expenses were $63 million, and we reported a net loss, of $156 million.

R&D expenses were 102 million G&A expenses were $63 million and we reported a net loss of $156 million.

As of June 30, 2022, TELUS had $853 million in cash, cash equivalents, and short-term, marketable securities. We expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing Empaveli launch, the global launch of Peg, Ceta, Coplin, and GA, and further development of our pipeline.

As of June 32020 to tell us at $853 million in cash cash equivalents and short term marketable securities.

We expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing <unk> launch the global launch of TEG, Cedar Copland NGA and further development of our pipeline.

We remain confident in TELUS's financial future as we continue to execute on our upcoming, milestones.

We remain confident in the palaces financial future as we continue to execute on our upcoming milestones.

I will now turn the call back over to Cedric for closing remarks.

I will now turn the call back over to Cedric for closing remarks Cedric.

Cedric?

Thank you, Tim.

Thank you Tim we.

Tim, we are excited about the many opportunities ahead.

But I think, you know, there's many product profiles, but two that stand out as being particularly attractive.

We are excited about the many opportunities ahead.

By year-end, we will expect to advance our position, as the global leader in complement with two commercial products and a robust pipeline encompassing multiple late-stage rare disease programs and, additionally, preclinical programs heading into the clinic.

One is you have a patient who has lost all vision in one eye and wants to save as much vision as possible in the fellow eye.

By year end, we would expect to advance our position as the global leader in complement with two commercial products and a robust pipeline encompassing multiple late stage rare disease programs and additionally, preclinical programs heading into the clinic.

Those are patients that probably you're going to want to treat as aggressively as possible, maybe with monthly dosing.

But then the other one, the one that you alluded to, is you're a newly diagnosed patient, maybe in your first eye.

We look forward to continuing to share our progress, as we build on the company's momentum.

We look forward to continuing to share our progress as we build on the Companys momentum.

Let us now open the call for questions.

You have an extra fovea, and even the fovea is not affected.

That is now open the call for questions operator.

Operator?

It's still small, and you're going to want to make that investment in getting the most benefits over a long period of time.

Okay.

If you have a question or a comment at this time, please press star 1-1 on your phone.

And you're going to treat that patient with every two months dosing.

Question or a comment at this time. Please press star one on your phone, we will pause for a moment, while we compile our Q&A roster.

We'll pause for a moment while we compile our Q&A roster.

Our first question comes from Madhu Kumar.

Our first question comes from Madhu Kumar Europe with Goldman Sachs. Your line is open.

You're up for the Goldman Sachs.

Your line is open.

Hey, everyone. Thanks for taking our questions. So I guess two from US. So the first one is a question we've been getting a lot recently some investor is is how to think about some of the disclosed. This can you make optic neuropathy events that were mentioned in the ARVO presentations few months ago. So how are you guys thinking about ion and how you're thinking about in terms of kind of ongoing review process.

Hey, everyone.

Thanks for taking our questions.

So, I guess two from us.

For Pegging G H.

Good question, we've been getting a lot of from investors is how to think about the recently passed drug pricing reform. That's part of the inflation reduction acts that happened over the weekend.

How do you think that impacts the drug lag pegs set a copay and that is largely bias towards patients on Medicare in elderly patients and has kind of like a big market opportunity framework. So any visibility on those two points would be greatly appreciated.

Thank you so much Netherlands, great to hear you. So first of all on the <unk>.

So, the first one is a question we've been getting a lot recently, is how to think about some of the disclosed ischemic optic neuropathy events that were mentioned in the Arvo presentation a few months ago. So, how are you guys thinking about ION, and how are you thinking about it in terms of kind of the ongoing review process for PEG and GA?

And, again, there is something there that we will continue to evaluate that we spoke about at the 18-month time point, which is that with every six-month segment, we saw that the reduction in the lesion growth became better, not linearly, but essentially the efficacy profile of the drug seemed to improve over time.

Now, we're going to see that's not a requirement for approval, of course, but it is something that is very exciting when you think about treatment not for two, but five or ten years, especially for those early lesions.

Okay. So no assays for chemical optic neuropathy.

So, we're going to find out what happens between month 18 and 24.

Between the 18 and 24 month standpoint, so as you may recall between the two studies, we had one case between month six and 12, two cases between 12 and 18.

But if that trend from the first three segments continues, that's something very exciting that I think we can then look forward to.

Extra fovea lesions early on, newly diagnosed, and making a long-term investment with every other month dosing, we believe is very important.

We're again sufficient thats versus objected to this also has kind of comorbidities.

And why this happened.

But it's something that we continue to track because we were very happy to see that.

It does not occur again, and it's something that we are concerned about at this point in time.

Second question we've been getting a lot of from investors, is how to think about the recently passed drug pricing reform as part of the Inflation Reduction Act that happened over the weekend.

Okay.

I'm going to hand, it over to Ed just talk briefly about the pricing.

How do you think that impacted drugs like PEG, as I said to Copeland, that is largely biased towards patients on Medicare, kind of elderly patients, and has kind of like a big market opportunity framework?

And if I could, ask a follow-up.

Thanks for the question, Matt. So obviously, we are monitoring this.

So, any visibility on those two points would be greatly appreciated.

So, you know, a lot of the payoffs we've talked to are looking for continued improvement over, time and maybe separation of slopes, you know, that you've shown in the segment data every six months.

But as far as expectations for 24 months, I guess you've somewhat downplayed what we, might be able to see at 24 months, but if there's no further separation, do you think physicians will be motivated to continue to treat long-term?

Quite closely but we believe the direct impact on our <unk> portfolio is currently pretty limited and let me explain a little bit thinking so let's start with anybody right.

Thanks.

Thank you so much, Madhu, and great to hear you.

So, first of all, on the ION cases.

We don't think can be subject to negotiation until 'twenty.

And even that and we think it's probably unlikely that Medicare spending on the drug would be sufficient to result in CMS seeking to negotiate a price for the drug.

As a reminder of our call.

Right.

<unk> represents 25% of the card business now.

Now, obviously with future indications.

The Medicare spend we determined that likelihood.

The ability for inclusion or negotiation in the future now as we move to <unk> and interventional pain.

Based on the most recent bill language again, the drug would not be subject to negotiation until early 2013.

Yes.

Obviously at the moment.

Determine a likelihood of negotiation until later in the 2010 20 <unk> when we have more data on the spending on peg NGA and how that compared to other Medicare products.

What is interesting is obviously currently our composition of matter patents for peg.

Buyer in the early 2013.

So even with the negotiated price potential and without any really have an impact for two to three years and so our IP is so as we as I said at the beginning I think at the moment as we can see the bill we believe the direct impact on our pallets and helpful.

So, no assays for ischemic optic neuropathy, were reported between the 18 and the 24-month time point.

Is this something that we have an idea of, is it just so they're looking at sustainability, or do they really want continued separation?

And currently limited.

No, thank you, Annabelle.

I think, look, if you continue to stay in photoreceptor cells the way we believe you, will, right, even if that is a linear saving, so if you stay, you know, around that 20 percent or even a little bit below that for a reduction in the growth of geographic attributes based on the research that we did with the retinal community, that is sufficient.

Should we get, you know, an increased effect over time, that would, of course, be very, exciting and something that we can then explore at that point in time, but it's not, we believe, a requirement for adoption of this drug.

Great. Thanks for taking my questions.

And one of them are for our next question.

Our next question comes from Raimo <unk>.

With Evercore your line is open.

Great.

Hi, guys. Thanks for taking my questions, maybe a couple of them. If I may 1st could you clarify and I know theres been a lot of confusion on this could you clarify.

So, as you may recall, between the two studies, there was one case between month 6 and 12 and two cases between month 12 and 18, where, again, the patients that were subjected to this also had, you know, kind of comorbidities that could explain why this happened.

But it's something that we continue to track, but we were very happy to see that it does not occur again, and it's not something that we are concerned about at this point in time.

Any cases, they try this uveitis or ion.

Phase II filly trial that may not have been in the presentation and I think there's one case and Sham for example, if you could speak to that and then secondly.

Folks listening in I know, there's been a lot of.

Interest and understanding.

The profile on the cloud side for Bellevue from their phase III experience. If you could speak to any observations along those lines from from your data to date.

I'm, specifically, referring to the inclusion of <unk> and <unk> and if there's any been anything like that thank you very much.

Thank you.

Thank you so much for that question, so and city, we had a case of Iowa, and the Sham control and the unseated fell away as well.

And Thats as I already mentioned.

The previous question.

<unk> is something that does occur naturally in the elderly population and it used to be something that occurs more commonly.

<unk> received in traditional injections something that we know also from the.

Patients that arent seeing movement and adjust.

Also the cadence of the strategies go hand in hand, with the intra ocular inflammation background that we have for this and traditional administration of fixes that combat.

In the cases that we have first of all on the on.

On a qualitative basis are different from what we see with <unk>. We did the same store NOI that we had predicted.

Therapy.

Can be very disruptive to the EIA.

The profile that we have seen for the case submission are.

First of all quantitatively very low and in line with what you would expect from patients on interventional treatment and also not on the guidance.

I will turn to them. So we believe that the safety profile.

<unk> continues to be very favorable.

Look forward to reporting a 24 month of investment as well.

And subject would you guys be able to speak to vision loss with any of these cases when the 24 month data comes out I don't want to put you on the spot right now.

Okay.

Well I mean look we will of course elaborate more on the safety profile, including on.

What exactly the impact of these cases are when exactly we will do that remains to be determined so I'm not sure it will.

The top line unless it is considered meaningful.

But definitely in the future, we'll talk more about that thank.

Thank you.

One moment for our next question.

Our next question comes from Joseph Stringworth Needham.

Our next question comes from <unk> Rama with Jpmorgan. Your line is open.

Your line is open.

Yeah.

Hi.

Hey, guys. So much for taking my question and congrats on all the progress, particularly on the G&A side.

This is Ben Ricard on for Joey Stringer.

I wanted to.

Ask a question on the 24th.

Derby and Oaks.

Coming on back of some of your opening comments so.

And of note last week.

That sort of etsy to Copeland preservation.

Reservation.

Relative to basis, and or a couple letter relative thibault.

A win scenario where tobacco.

Thanks.

Thank you so much for the question. So we look forward to the 24 month data.

In September as mentioned.

On the functional endpoints as we have always said we believe that.

Those end points.

But we know that those endpoints are not relevant to the FDA and the reason for that is that measuring functional endpoints.

<unk> is very valuable and takes a long time to manifest itself.

On the baseline although lower than you are on treatment. So it all comes down to seeing the correlation between the reduction in lesion growth and showing that you state of Florida, Recept herself and estimating how in the long run that will actually impact.

The functional endpoint, so we will be working on that.

So we expect it to be in line between at 24 months I'm not sure what difference yes.

Both statistical.

Please note that we will have though.

<unk>.

The FDA approval process.

Thanks for taking our question.

Thanks, so much for taking my question.

Thank you.

Just a quick one.

Next question.

Our next question comes from <unk> <unk> with Bank of America. Your line is open.

You kind of mentioned a little bit about the Impavelli payer mix.

I think I heard around 25 percent Medicare, but just the overall payer mix, would you, still characterize that as relatively stable around 50-50, or do you expect that trend to continue or change?

Hi, guys. Good afternoon, and thanks for taking my question.

Thanks.

As it relates to dosing frequency is every other month, so something thats realistically on the table as far as your discussions with the agency and do you think that physicians, having flexibility to Joseph either once a month or once every other month is going to be important for commercial uptake and then secondly can you just give us an update on where you are with.

Thank you, Iga.

I'm going to hand that over to Adam.

Yes.

So, yes, the majority of Impavelli payer is obviously commercial, and as we said before, 25 percent is a Medicare population.

I expect that to continue.

Ramping on the commercial front in terms of.

Hiring people and when they would be trained and would you be ready to go on day, one if you got it.

Great.

In November thank you.

Thank you very much.

Thank you so much Doug so not only every other month on the table.

One moment for our next question.

<unk> profile that we are very excited with us right. So.

When you look at the efficacy profile that we would more than 18 months, we'll see what happens in 'twenty four.

Our next question comes from Douglas Au with H.P.

You get a lot of advantages maybe as much as 90% of the benefits with every other month injections.

Wainwright.

Your line is open.

Treatment was helped a number of injections right. So something that is very exciting to us is something that we will continue to evaluate.

Hi.

To get to your point on the competitive profile.

Good afternoon.

We have several elements that position us favorably competitively as well first one of course against the ability to dose every two amongst secondly, the effects that we have reported all of the data to the FDA all the way up to 18 months, because I think a reasonable expectation that should we get approval, but that will be included into the table.

Thanks for taking the questions, and congrats on the progress.

We also have of course, both wholesale as well ex stressful healed patients that were included from a broad patient population.

All of which we look forward to talking about some more.

I'm going to hand it over to Adam, to talk briefly about the pricing.

I'm going to hand, it over to Adam spoke briefly about what we are doing in terms of commercial prep pay to Athene. It's Adam. Thank you for your question. So yes, we are.

Thanks for the question, Madhu.

Just maybe as a follow-up, you made the comment about, you know, a lot of trying to start, patients early, especially with every other month dosing.

We are ready to go we are starting to look for all of our field based teams prior.

So, obviously, we're monitoring this quite closely, but we believe the direct impact on Appellate's portfolio is currently pretty limited. And let me explain a little bit our thinking.

So, let's start with Empavelli, right?

Over the last couple of months and we have now in the process of Onboarding all of them. So quick step back prior to the Great News we.

Had hired the high level leadership roles within the U S. The high level leadership roles within Europe and rest of world.

And now we're going through the training process over the next couple of weeks to fully onboard the field based teams from a medical affairs perspective, and a market access perspective, as well as any more sales and marketing people.

A huge amount of interest.

And people wanting to join our company, which is super exciting obviously, we are getting ready for our November date.

So, Empavelli, we don't think, can be subject to negotiation until 2030 at the earliest.

And even then, we think it's probably unlikely, that Medicare spending on the drug would be sufficient to result in CMS seeking to negotiate a price for the drug.

And the second part of your commercial ramping question was are we going to be ready.

As a reminder, right, of our current sales, Medicare only represents 25% of the current business.

At that time and the answer is absolutely and that's our plan I mean with a high unmet need NGA, we're going to do.

Everything that we can be ready.

Mediately post that Paducah date.

Teens, exactly where they need to be today.

I'm just curious, how do you think about providing guidance to clinicians about when the time, might be appropriate to switch a patient from every other month dosing to monthly dosing?

Thank you.

One moment for our next question.

Yes.

Now, obviously, with future indications, and the extent of the Medicare spend, we've determined the likelihood of eligibility for inclusion or negotiation in the future.

Yeah, thank you so much, Doug, for that question.

Our next question comes from literally Lyla Youssef with Cowen Your line is open.

Now, if we move to GA and Intravitreal PEG, based on the most recent bill language, again, the drug would not be subject to negotiation until early 2030s at the earliest.

Obviously, at the moment, we can't determine the likelihood of negotiation until later in the 2020s, when we have the more data on the spending on PEG in GA and how that compares to other Medicare products.

So I think, look, there is a dose response, right, but that dose response is not like, you get quite the benefit from doing the monthly injections from what you get from every other month, right?

What is interesting is, obviously, currently our composition of MAPSA patents for PEG expire in the early 2030s.

So, but to your point, if you are a patient who has foveal encroachments, which means, that you are now at risk for losing central vision, and especially if you are already blind or have lost vision in the other eye, that is a strong motivator to, you know, extract as much efficacy as you can.

Alright. Thanks, so much for taking my question and congrats on the front end maybe quickly on the European filing.

So, even with a negotiated price potential, it would only really have an impact for two to three years until our IP hits.

So, as I said at the beginning, I think at the moment, as we can see the bill, we believe the direct impact on our pallets and our portfolio is currently limited.

So that's something that we will continue to evaluate over time.

Next question comes from Umer Raffat with Evercore, your line is open.

And again, every other month for us is something that is very important competitively as well.

I mean, again, to kind of reiterate, we have the first-mover advantage, we have every other, month dosing, we have data up to 18 months included in the file, and then we have patients with foveal as well as extra-foveal lesions that are included in this profile.

Thank you Mr. Yang.

Can you maybe clarify what else is outstanding.

One month data for that is any component of that may be dependent on feedback from the SBA.

Hi guys, thanks for taking my question.

Be it that quick.

Maybe a couple of them if I may.

I appreciate that.

<unk> Com currently.

I think your understanding as well.

That line of thinking.

Actually change their mind.

On the AD com given.

So it is something that we believe covers all populations that have this disease, whether, it's early, late, whether it's foveal, extra-foveal, and where we believe over the long run you can make a big difference in terms of saving forever.

Okay.

Thank you so much by that so for us.

It was limits marvels that I believe that yes to both of the European submission, including the 24 month data.

Which is what we R&D is going to do and we plan to file before the end of the year.

I'm not sure whether you had a question more specific to that.

Yes.

If there is anything else that was outstanding Arthur waiting on feedback from the FDA that could help change that timing.

No. So this is not needs to feedback from the FDA, just including the 24 months.

And then as it relates to the no eskom so.

I believe from my understanding.

Up to six weeks before the due date.

You can have an outcome.

I think thats considering.

Considering this very tight timelines that we have that of course the longer.

Gross size of this.

<unk> comes to still organized so far we have not received any indication that there wouldn't be one I think it's also worth mentioning that the feedback that we gave as it relates to the regulatory communication was felt in rising and as to the best of our knowledge of course.

Thank you very much for the color.

Next question.

Our next question comes from Stephen Suite helps with Raymond James Your line is open.

First, could you clarify, and I know there's been a lot of confusion on this, could you clarify any cases of vitreitis, uveitis, or ION in Phase 2 Philly trial that may not have been in the presentation?

And just as a follow-up, I'm just curious, in the conversations with KOLs, do they appreciate, how much bang for your buck you get from every other month of dosing?

Yes, hi.

And I think there's one case in Sham, for example, if you could speak to that.

Does the drug work or not?

And then secondly, folks listening in, I know there's been a lot of interest, in understanding the profile on the clouding side for BofU from their Phase 3 experience.

I think, you know, we've clearly shown over time that it does work and that it works well, that it may potentially work better the longer you treat, and that with every other month dosing, you're close to probably in the range of 90% of the efficacy profile of monthly with half the number of injections.

That's not a part of the message that we focused on, but something that we will focus on a lot in the months and years to come.

Thanks for taking the question.

So if you could speak to any observations along those lines from your data to date.

Okay, great.

And I'm specifically referring to the occlusion scene in BofU, and if there's anything like that.

Just from a statistical analysis plan standpoint, when the FDA reviews. The GI submission is the primary analysis 12 months in all three studies or 18 months in Derby and Oaks, and just given the availability of the 18 month data in the filing are you still.

Thank you very much.

Thank you.

Sort of needing to specify the affiliate and Oaks or the two positive well controlled studies or do all three studies fit that criteria now.

Yeah, thank you so much, Umer, for that question.

Yes. Thank you so much Steve so.

The FDA considers this primary analysis endpoint is 18 months in Derby and Oaks.

So in Philly we had a case of ION in the Sham control in the untreated fellow eye as well.

And that's, as I already mentioned in the previous question, ION is something that does occur naturally in elderly population, and it appears to be something that occurs more commonly when patients receive intravitreal injections, something that we know also from the patients that are on treatment with anti-NHS.

Also the cases of vitreitis go hand-in-hand with the intraocular inflammation background, that we have for this intravitreal administration of pexitacotam.

Of course the team it was up to 12 months it was at 12 months.

And the IOI cases that we have, first of all, on a qualitative basis, are different from what we see with BofU where, you know, really the types of IOI that we had or that you have with that therapy can be very destructive to the eye.

The profile that we have seen for the cases of inflammation are, first of all, qualitatively very low and in line with what you would expect from patients on intravitreal treatment and also not of the kind that we are concerned about.

So we believe that the safety profile, you know, continues to be very favorable, and look forward to reporting 24-month data soon as well.

Correctly.

Find out that it was very important to us to get an adjudication on Sealy in November last year.

It gives us confidence and also allowed us to prepare the NDA.

And already without spending a lot of time trying to understand therapy and with the confidence that overtime Derby with catch up to the <unk> trial and that is what we saw happening at the 18 month data growth quarters. The P values.

And Cedric, would you guys be able to speak to vision loss with any of these cases, when the 24-month data comes out?

And we will continue to see what happens as to 24 months, whether thats all.

<unk> continues to take place.

Okay, and then just quickly for APL 2006, what precisely is the indication of our eligible patient for that product just wet AMD.

So we are going to be talking about this more in the future for those on the call that are not familiar with this product and this is something that combines <unk> with an anti C. Three access more than a single molecular entity.

So it will be something that we believe will become very valuable in the context of early treatment.

Either for within the <unk> cash receipts and how we are going to approach. This from a regulatory and development perspective is remains to be determined.

Alright, thanks, very much for the questions.

And I'm not showing any further questions at this time.

One moment for our next question.

I don't want to put you on the spot right now.

I'd like to turn the call back, over to Cedric for any remarks.

Our next question comes from Christopher Howerton with Jefferies. Your line is open.

Well, I mean, look, we will, of course, you know, elaborate more on the safety profile including on, you know, what exactly the impact of these cases are.

Thank you so much.

When exactly we will do that remains to be determined.

I'm not sure.

So I'm not sure we'll do that in the top line unless it's considered meaningful.

Did you hear that for any remarks, Cedric?

Hi team this is comedies on for Chris.

But definitely in the future we'll talk more about that.

My closing remarks are not opening.

I just want to thank all of you for joining.

Thank you.

We are really excited about the progress that, we have made and what's ahead for us.

Maybe.

On kind of <unk> and fidelity label expansion opportunity can you help us understand the mechanistic differences between IC and PGN in CPG.

In September, we will report the 24-month data, and we will be around later today and tomorrow should you have any additional questions.

What proportion of these posts of the post transplant patients have recurrent disease.

And do you expect <unk> will perform as well in more severe patients.

Put the kind of more moderate patients.

And then maybe as a second indication for <unk> can you help us understand the task score endpoint and what will be important to demonstrate in terms of survival time in terms of ALS functional rating score.

One moment for our next question.

Thank you again for joining us today, and have a wonderful day and have a wonderful rest of the week.

Your next question comes from Andrew Pomerama with J.P. Morgan.

Well, ladies and gentlemen, this concludes today's presentation.

Thank you very much.

Your line is open.

You may now disconnect, and have a wonderful day.

The conference will begin shortly.

Thanks Colby.

So on the CTG indications, so we kind of think about the CPG for that matter the <unk> population.

Hey, guys.

Kind of three buckets. The first one is newly diagnosed patients typically at a lesson.

Thanks so much for taking the question, and congrats on all the progress particularly on the GA side.

I wanted to ask a question on the 24th Derby, and Oaks upcoming on back of some of your opening comments.

So in a note last week we had that sort of Pecceda-Copeland preservation, relative to base and or a couple letters relative to Sebo as kind of a win scenario.

Where would you push back on this assessment?

Thanks so much.

Thank you so much, Anupam, for that question.

So we look forward to the 24-month data.

Still with well functioning kidneys, but with of course, a path towards kidney failure.

The progression of the disease typically means that over the course of 10 years half of your patients who will go into end stage renal disease.

So of course, when you and your teams not a lowest time.

The second bucket of patients. Therefore are those that are having significant loss of renal function, sometimes with different nephrotic syndrome.

And those are patients where efficacy becomes crucially important to avoid of course dialysis or let alone transplantation and then to your point. The third category of patients are those that have been transplanted and <unk>.

Recurrence again is something that occurs in more than half of the patients.

And something where we believe we can have.

Excellent and avoiding that from happening.

In, September, as mentioned, on the functional endpoints, as we have always said, we believe that, you know, those endpoints, well, we know that those endpoints are not relevant to the FDA, and the reason for that is that measuring functional endpoints is very difficult to do, is very variable, and takes a long time to manifest itself on a baseline, or let alone when you are on treatment. So it all comes down to seeing the correlation between reduction in lesion growth and showing that you have safe photoreceptor cells and estimating how, in the long run, that will actually impact the functional endpoints.

Then as it relates to that.

So the primary endpoint that we have there is a combined assessments of function and survival.

This is an endpoint that was discussed not just with U S regulators, but also internationally.

And the study is a registrational phase II clinical trial.

So.

It is properly powers should it have a positive readouts to obviously loves to file in the various jurisdictions.

Great. Thank you and then one quick follow up is there any lessons you can learn from kind of a systemic administration.

At the valley for ALS that you may be able to apply chair.

In critical programs are.

Nothing nothing there thanks again and that's my final question.

Yes, so I think look.

As many of you know and as you cite as Phil before Windows <unk> assistant ambitions with Alice.

But we also all know that <unk>. There is many things that FIFA controlled personal to be show that very clearly of course <unk> that was the source of our approval there.

We are now well north of 600 patient years of dosing with <unk>.

Thank you.

The point that we will be talking about more of as we haven't seen a single case, so far of many local infection not one whereas at this point in time Shouldnt have been on the C. Five inhibitor is probably reasonable than expected in the range of three cases, if not more so that is something thats.

We're very excited about the safety profile that is building as we get more patients on <unk> and.

Something that should we have a positive result.

The other indications, where we're testing both of course defended very beneficial as well.

Thank you one moment for our next question.

To raise your hand during Q&A, you can dial star 11.

So we'll be working on that.

Thank you.

Our next question comes from Carlos <unk> with RW Baird. Your line is open.

Ladies and gentlemen, thank you for standing by.

So we expect it to be in line between, at 24 months, to not show a difference yet, at least not statistical, and we believe that that will have no impact on the FDA approval process.

Welcome to the Apellis Pharmaceuticals' second quarter 2022 earnings call.

Hi, good afternoon, and thanks for taking our question as a follow up to Steve's question earlier on the 18 month data.

Thanks so much for taking our question.

Based on any feedback you've received from the FDA, how do you see the 18 months data sitting in to the filing.

Specifically as it relates to the 12 month data.

Thank you.

At this time, all participants are in a listen-only mode.

I think thats. Thank you calling for that question.

Okay, we'll move on to our next question.

After the speaker's presentation, there will be a question and answer session.

It was very important for us to include the 18 month data. So when we got the readout in September and of course, the disappointments over narrowly missing the primary end point in Derby.

Our next question comes from Casina Med with Bank of America.

Your line is open.

Hi, guys.

Good afternoon, and thanks for taking my question.

We had two important strategic steps that we took the first one was to get that adjudication in Chile that we got in early November the <unk>.

As it relates to dosing frequency, is every other month still something that's realistically on the table, as far as your discussions with the agency?

Second one was our decision in January to go to the FDA and to propose in our pre NDA meeting that we would include the full analysis for safety as well as efficacy all the way up.

Up to 18 months, hoping that there would be a catch up of <unk> and as you know that is indeed, what happened right. So.

The data up to 18 months was submitted and the primary endpoints of interpretation was very important within 18 months.

So I think.

Create a very complete picture for the FDA.

I think it was a good decision too.

To do that.

It's a very complete picture for the FDA.

I think it was a good decision to do.

To do that.

Im not sure that answers your question Cody.

Great. Thank you.

And do you think that physicians having flexibility to dose either once a month or once every other month is going to be important for commercial uptake?

Are there any avenues that you are aware of that the FDA has available to get feedback from industry experts outside of a formal AD com or if there is no AD com how should we assume there is no interaction between the FDA and the field during its review.

Yes so.

Look I think.

Mitchell from electrical division at the FDA, we have.

Very well informed and well run division that has been stable for a very long time, our leadership there has been therefore.

I believe it's now three decades.

And I know for effect that this is a division that has a very deep interaction with key opinion leaders in this field. So.

The reason why there was no <unk> im not going to speculate on.

Leave that this filing was just rates for risk based on the content that we submitted.

And it seems that they agree with us.

But we also know for our sector theres lots of interactions that happen offline.

Great.

Got it that makes sense. Thank you and last one for me just on the manufacturing part of the filing you submitted can you make any high level high level comments, there when the CMC inspection might occur.

Yes.

So manufacturing of the drug substance is the same as it is for any retrospective that go with them.

As you know, we got our approval for <unk> without a single 483 issues.

<unk> and <unk> manufacturing.

We don't know if youll get inspections on the manufacturing side or should we have any we feel very comfortable that we will be able to.

To come out of those processes.

Great. Thanks for taking our questions.

To ask a question during the session, you need to press star 1-1 on your telephone.

Thank you.

One moment for questions.

Our next question comes from Derek <unk> with Wells Fargo. Your line is open.

I would now like to turn the call over to your host, Meredith Kaya.

And then secondly, can you just give us an update on where you are with ramping on the, commercial front in terms of hiring people, and when they would be trained, and would you be ready to go on day one if you got approval in November?

You may begin.

Hey, good afternoon, guys. Thanks for taking the question just.

<unk> costs. The first I was just wondering if.

Thank you.

The FDA discuss with you any potential finding either safety or efficacy.

Thank you so much, Tati.

24 month data done that might prompt the dotcom where required.

So not only is every other month on the table, it's a product profile that we, are very excited about, right?

Four month data to be submitted as part of the review.

Then one question on <unk> I guess, how are you tracking the plan launch in I guess.

What are the major benefit of the inclusion of the <unk>.

Steve.

The issue is that addressing the launch thanks.

Good afternoon, and thank you for joining us to discuss Apellis' second quarter 2022 financial results.

Thank you Derek I will handover to the financial question to Adam.

But as it relates to the 24 month data I think it's important to note that we don't expect any surprises between 18 to 24 months. So we believe to see an extension.

So when you look at the efficacy profile that we reported at 18 months, we'll see what happens at 24, you get a lot of the benefits, you know, maybe as much as 90% of the benefits with every other month injections, every other month treatment with health and number of injections, right?

Both the efficacy as well as the safety profile as it was established at 18 months. So I think that is the way the.

I looked at it that's the way we look at it.

Of course.

Unexpected emerge at that point in time, it's hard to know, what's what actions would be required or what we would do but thats not something that we believe will be the case.

And then for <unk> I will hand, it over to Ed.

So something that is very exciting to us, something that we will continue to evaluate.

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.

Thanks, Eric.

Obviously, we are entering year two of our launch and internally, we've now pivoted our strategy, what we call phase II right, whether it's starting to target new sensors and new physicians.

Before we begin, I would like to point out on slide 3 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 all for joining us today.

2022 is a transformational year at Apellis, and we are making great progress across each of our key priorities.

I'll start with geographic accuracy, or GA. A few weeks ago, we were thrilled to announce that our NDA for intravitreal Paxieta co-plan was accepted by the FDA with a priority review designation and a PDUFA date of November 26, 2022.

The FDA also stated that it is not planning to hold an advisory committee meeting to discuss the application.

We need to drive those sources of demand.

This is the best outcome we could have hoped for, and I am so proud of the Apellis team for their efforts in getting us to this pivotal point.

We'll keep talking about start forms and switches from <unk>, five rems certifications et cetera.

The NDA includes all available data from our Derby and Oakes studies out to 18 months, and in the case of some patients, even longer, as well as the 12-month data from our Philly study.

The 48 week and print.

Just really solidifies.

First slide treatment of choice for PMA trial, the more data that we have in the label the more robust conversations we can have with <unk>.

Collectively, these data reinforce the potential for Paxieta co-plan to meaningfully slow disease progression and become the first ever treatment for the millions of patients living with GA, a relentless disease that is a leading cause of blindness worldwide.

To get to your point on the competitive profile, you know, we have several elements that position us favorably competitively as well. First one, of course, again, the ability to dose every two months.

Actions.

Long term efficacy and safety, but also on treatment naive, we're making a really good inroads with treatment naive patients and I'll give you a little.

Secondly, the fact that we have reported all of the data to the FDA all the way up to 18 months with, I think, a reasonable expectation that should we get approval that that will be included into the label.

We also have, of course, both foveal as well as extra foveal patients that were included, so a broad patient population, all of which we look forward to talking about more.

Inside our July Stockholm over a third of our July start forms were treatment naive patients. We continue to see growth as physicians start to broaden that use.

We continue to work with the agency in our efforts to bring this therapy to patients who currently have no approved treatments.

In parallel, we are also ramping up our commercial preparations so that we are well positioned to bring intravitreal Paxieta co-plan to patients immediately upon potential approval.

In Europe, we are on track to submit our application to the EMEA by the end of this year.

From those with the highest unmet need.

Larger and broader PMA, which patients in treatment naive patients. So I expect to see us continue to progress and accelerate as we enter the next phase of our launch so that's how as a presentation that 48 week Pegasus data help us out.

I'm going to hand it over to Adam to talk briefly about what we are doing in terms of commercial prep.

Hey, Cezine, it's Adam.

So thanks for your question.

Great. Thanks, so much for answering the questions.

So, yes, we are ready to go.

And one moment for our next question.

We, started to look for all of our field-based teams prior over the last couple of months, and we are now in the process of onboarding all of them.

Our next question comes from Justin Kim with Oppenheimer. Your line is open.

So a quick step back prior to this great news, we had hired the high-level leadership roles within the U.S., the high-level leadership roles within Europe and the rest of the world, and now we're going through all of the training process over the next couple of weeks to fully onboard the field-based teams from a medical affairs perspective and a market access perspective as well and any more sales and marketing people.

Hi, good.

Good afternoon, and thanks for taking the question just maybe one question from us.

We will include the 24-month data from Derby and Oakes in our submission, which we plan to report in September.

I know thats. The 24 month data may not be sort of that point, where you can see separation on visual acuity, but how should we think about scale.

And sort of that sort of duration of treatment as you combine it with potentially Derby I know is that something that could show maybe that hinder.

Or separation just wondering.

How we should think about that study.

We had a huge amount of interest in people wanting to join our company, which is super exciting, and obviously we are getting ready for our November PDUFA date.

Today, we'll speak to this a bit more in a few minutes.

Yes. Thank you very much for that question Justin So Gail is something that we are incredibly excited unhappy with threat. So for those not familiar with that its three year extension on the patients from Derby and Oaks that we then enroll.

Turning to PNH, we remain focused on further establishing Empavedi as a first-line treatment for patients living with PNH.

We are seeing continued strength across a number of key indicators, translating to $15.7 million in U.S. net revenues for the second quarter.

Globally, our partner Sobe is also making progress in bringing empathe influenza to, patients with PNH outside of the U.S.

Beyond PNH, we continue to advance empathe influenza as a transformative therapy for, rare complements-driven diseases.

Together with Sobe we now have four later-stage clinical programs underway.

We are also continuing to progress our early-stage pipeline, with INDs planned for APL2006 and, our siRNA program in the first half of next year.

We are also continuing to advance our preclinical work with APL1030 for potential use in neurodegenerative, diseases, but no longer expect to submit the IND by the end of 2022.

On the finance side, we ended the second quarter with approximately $850 million in cash, providing, runway into the first quarter of 2024.

To continue to money tour.

The function of how the lesion size reductions in safety profile themselves overtime and its also something thats very important to us competitively. So again, we have every other month dosing we have our first mover advantage, we are facing not defensive filing.

This puts us in a uniquely strong position in this challenging market environment as, we head into a potential launch later this year.

We look forward to building on our momentum as we further cement our position as a leadering, complement across multiple therapeutic areas.

Both types of patients with <unk> was extra full realization and then again the ability to looking Gail as to what happens in the long run.

Something very important to us.

We will talk about in the years to come.

And with that, I will turn it over to Adam.

Great. Thanks, so much.

Thank you, Cedric.

And the second part of your commercial ramping question was, are, we going to be ready at that time?

Turning to slide five, we are now in our second year of commercial empivelli in the U.S., and as Cedric mentioned, the commercial launch remains strong.

Thank you.

And the answer is, absolutely, that's our plan. I mean, with a high unmet need in GA, we're going to do everything that we can to be ready immediately post that PDUFA date.

We are continuing to see positive trends across the key leading indicators.

One moment for our next question.

So the team's exactly where they need to be today.

In the second quarter, approximately 30 start forms were generated, bringing the total number, of start forms since launch to approximately 190.

One moment for our next question.

Over 75% of C5 inhibitor patient switches are continuing to come from Altamiris.

Second comes from Douglas <unk> with Citi. Your line is open.

Hi, great. Thanks for taking the question I think Federico you said that the EMA wanted to see the relation between preserving visual function and lesion growth. So could you just expand a little bit on what data specifically youre going to leverage to make this point to EMA. Since you said that the 'twenty 'twenty four month update we won't be sufficient to show the separation.

On the functional endpoints.

Our next question comes from Leila Yousef with Cowen.

Thank you for the question so.

Well, let me try to the 24 months.

Not being something significant doesn't mean that may not be sufficient to show trends on the data. So we're going to do.

Look at what we get from the study.

You bet.

Natural history data to find the relationships between the functional endpoints.

Sorry between that ophthalmic endpoints.

Function that nonetheless, Saudi may come from central visual acuity, which is hard to measure so we're going to be doing a little more investigation on the data in the study.

Do you see what correlations we get.

Okay. Thanks, and then just Adam could you just tell us if you could what percent of the <unk> market you believe you've captured so far in the U S.

Yes.

We got also obviously, we think there are 1500 <unk> treated patients.

We have over 200 stockpile of approximately 190 to 200 stockpiles so that should give you a good.

Hence if how the progress that we're making.

As we got we obviously don't give guidance on revenue or anything along those lines.

With over 200, Rems certified physicians and start forms continue to come in and we think we're really.

Patient compliance rates remain high at 95%, and we have established strong formulary access, amongst the top 20 payers.

Making good progress in converting five patients starting treatment naive patients with <unk>.

Now in the second year, we are heading into the next phase of our commercial strategy, which is expanding our focus to the broader PNH community by further positioning empivelli as first-line treatment for all patients with PNH. We are refining our physician targeting so that we efficiently call on those prescribers, who are treating the majority of PNH patients.

Okay. Thank you.

We are also advancing our outreach to key thought leaders, especially now that Dr. Hillman, is fully onboarded.

Yes.

One moment for our next question.

Your line is open.

In this next phase of launch, we will evolve our partnerships with new centers to drive, additional prescribers and ensure that patients with PNH have access to EmpaVeli.

Additionally, our SNDA, including the Phase III PRINCE results and the 48-week Phase III, Pegasus data, was accepted with a PDUFA date in February 2023.

Our next question comes from Ellie Merle with UBS. Your line is open.

Hi.

If approved by the FDA, this will allow us to strengthen our promotion of EmpaVeli for, treatment-naive patients and raise more awareness of our long-term efficacy and safety data.

Now, turning our attention to our progress in GA on slide 6, we are excited to be even, closer to our anticipated approval and commercial launch in this critical area of high unmet need. GA impacts 5 million people worldwide, including 1 million people in the U.S., and I expect, that the first approved therapy for this devastating disease may uncover even more patients.

Hey, guys. Thanks, so much for taking my question just first on the Io and can you just elaborate on the cases that we're seeing I guess, how the patients presented and how they were managing that.

Here at Appellus, we are compelled by the potential to bring the first-ever treatment, to patients as quickly as possible and excited by the FDA's decision to grant intravitreal pexetocoplin a priority review designation.

Let me now turn the call over to Fede.

Our focus prior to approval is on disease state awareness, specifically within the retinal, community and among some of the broader eye care groups.

At launch, our initial focus will be on the top 2,600 retinal specialists and injecting, ophthalmologists in the U.S. These physicians are managing the vast majority of GA patients currently.

We will expand our efforts over time to activating additional referral pathways to ensure that, GA patients are being referred to the right physician for treatment consideration.

We look forward to providing more granular details on launch preparation and execution, as we get closer to our PDUFA date.

Thank you, Adam.

It was resolved and then also specifically I think.

The data from our Derby and Oak studies continue to underscore the significant potential of, our C3 complement approach.

First question from Macquarie You mentioned.

Comorbidities application Pat if you could just kind of elaborate on that.

So, we're going to start with the clinical analysis of the treatment.

Maybe why this furnace.

Non truck related in those cases.

And then just second question just in terms of thinking about the real world the potential duration of use of anti VEGF and the cases I would say that's new.

On site activation, maybe just how youre thinking about that and how long anti that Jeff maybe year end.

Keith and I guess, if there's any data that we can expect that just from the 24 month data or I'm thinking about sort of a longer term study about the management of the nuance that excavations and thinking about the duration of use of anti that job. Thanks.

Thanks so much for taking the question, and congrats on the progress.

And we're going to use the patient-centered approach.

Thank you.

Maybe quickly on the European filing expected by the end of the year, GA.

Can you quickly clarify what else is outstanding besides the European filing?

Following the 18-month data reported in March, we have shared additional analysis at key retina meetings, reinforcing that treatment with both monthly and every other month in trabezoidal proxetacoflin in these studies demonstrated a clinically meaningful reduction in GA lesion growth with a favorable safety profile.

In May, we presented data showing the treatment with proxetacoflin continued to demonstrate a robust effect in patients with extra-foggy lesions and an improved effect in patients with foggy lesions as compared to what we observed in the 12-month results.

We also had a strong presence at macular society in June. This included data showing consistent reductions in GA lesion growth in treated eyes versus untreated fellow eyes. Proxetacoflin also demonstrated sustained reductions in GA lesion growth across all subgroups defined by increasing distances from the foveal center.

IOM case, the detail is not something we're going to talk about on this call.

Is any component of that maybe dependent on feedback from the FDA?

And then maybe a quick question.

First an enforcement point was to find out is these assays.

I appreciate that the FDA didn't request an adcom currently, but what is your kind of, understanding of the last possible deadline that they would have to essentially change, Thank you so much, Leila.

So it was a little bit marveled, but I believe that you asked about the European submission, and including the 24-month data, which is what we are indeed going to do, and we plan to file before the end of the year.

I'm not sure whether you had a question more specific to that.

They're becoming worse over time right I mean, we had one from six to 12 and then two from 12 to 18. There was of course I think your rightful considerations is going to be comverse startup and it didn't fit so we didn't have a single additional kit now as it relates to the.

Oh, yeah.

And just last month at the SRS, we shared analysis from Derby and Oakes that showed the mean rate or slope of GA lesion growth at 18 months. The results from this analysis were consistent with what we have shown previously at 18 months, with all nominal p-values for both dosing regimens below 0.05.

Collectively, all the data from Derby, Oakes, and Philly reinforced the potential of proxetacoflin to slow the progression of GA across the disease spectrum, which is critically important given the heterogeneity of this patient population.

We're excited to potentially bring the first-ever therapy to patients with GA with an opportunity to save as many photoreceptor cells as possible throughout the course of the disease.

To visa Europe members for the non <unk> expeditions.

Yes.

Derby and Oaks studies, when patients have nuances expedition, they get treated with anti VEGF on regular plus others.

In September, we plan to share top-line results from Derby and Oakes at 24 months. As you may recall, at 18 months, we presented pooled data showing that treatment with proxetacoflin resulted in increased efficacy over each six-month interval, 0 to 6, 6 to 12, and 12 to 18. We look forward to evaluating whether these improvements continue between month 18 to 24. If confirmed, it could mean that the longer patients are on treatment, the better their response to the drug. This could compound into very large lesion-size reductions over time.

At the end of the three year time period.

We have one prs that what does that mean people stop receding at that entity and then we find out how long does it take for these patients.

As we have mentioned before, and as literature will suggest, we do not expect to detect a difference between proxetacoflin and sham at 24 months due to the limitations of the functional endpoints and the relatively short period of time over which they are being assessed. We anticipate the separation to occur over longer periods of time.

We will include this 24-month data in our MAA.

We're confident in our ability to show this based on published natural history studies, and data from our phase 3 studies.

Moving on to our pipeline on slide 8, we're also working to deliver on the broad platform, potential of Empaveli to advance our rare disease franchise, which includes four later stage studies in multiple complement-driven diseases.

And we compare that between axis.

In May, we dosed the first patient in a phase 3 study with Paxetacoplan in immune complex, membranoproliferative glomerulonephritis, or ICMPGN, and C3 glomerulopathy, or C3G.

We also learned that FDA granted orphan drug designation for Paxetacoplan for the treatment, of ICMPGN. This designation had previously been granted for Paxetacoplan for C3G.

And the sham controls, so thats going to be interesting piece of information on which we will have more information.

The phase 2 study in hematopoietic stem cell transplant-associated thrombotic myocardiopathy, or HFCT-TMA, is actively enrolling patients.

Tim?

Our partner, Sobe, is currently screening patients in the phase 3 study in collaglutin, immune disease, or CAD, and has guided to now dosing the first patient in the second half of 2022.

And finally, we remain on track to report the top-line results of our potential registrational, phase 2 study in MS in mid-2023.

Let me now turn the call over to Tim for a review of the financials.

Next year as well, so guilds enforcing their again to find us.

What that means.

<unk> patients are going to be honest that adjust but I can tell you that in the studies to combined administration of anti VEGF.

And fixes that Copa is healthier this year.

Great. Thanks for the color.

If there is anything else that was outstanding, or if you're waiting on the next question, please go ahead.

Thank you.

Okay.

Thank you, Fede.

One moment for our next question.

Since we issued a press release earlier today with the full financial results, I will just, focus on the highlights for the second quarter of 2022, summarized here on slide 9. Total revenue was $16.3 million, which consisted of $15.7 million in Empaveli net product revenue, and $0.6 million in collaboration revenue from Sobe.

Our next question comes from Annabel <unk> with Stifel. Your line is open.

Thank you.

R&D expenses were $102 million, G&A expenses were $63 million, and we reported a net loss, of $156 million.

Great.

As of June 30, 2022, Appellis had $853 million in cash, cash equivalents, and short-term, marketable securities. We expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing Empaveli launch, the global launch of Peg, Ceta, Coplin, and GA, and further development of our pipeline.

I will now turn the call back over to Cedric for closing remarks.

We remain confident in Appellis' financial future as we continue to execute on our upcoming, milestones.

Hi, Thanks for taking my question.

So I realize im constantly cleaning the carpet final court, but you're studying <unk> in a range of disease severity.

So how do you envision approaching this market now it's clear from the data that the earlier the better but clearly the most desperate or the patients are a little tight.

And maybe getting relief benefit. So how are you initially going to be targeting this market as you as you as you entered the market.

I had a hard time hearing you.

Okay.

So if there is anything else that was outstanding, or if you're waiting on feedback from the, FDA, that could help change that timing.

Cedric?

Hello, Yes, sorry.

No.

Thank you, Tim.

So this is not linked to feedback from the FDA.

Sorry, yes, sorry, yes.

Tim, we are excited about the many opportunities ahead.

But Tim who is better hearing that maybe just to clarify this further.

We look forward to continuing to share our progress, as we build on the company's momentum.

It's just including the 24-month data.

Let us now open the call for questions.

Operator?

I think again one of the very exciting part of our data set is that every other month.

If you have a question or a comment at this time, please press star 11 on your phone.

With <unk> the number of injections seems to give you close to probably 90% of the benefit in terms of slowing down the progression of.

Geographic atrophy, so that fits very nicely with the product profile.

Theres, many product profiles, but two that stand out as being particularly attractive. One is you have a patient who is lawful vision in one eye and wants to save as much business as possible in the fell away.

Those are patients that probably you are going to want to treat as aggressively as possible <unk> monthly dosing, but then the other one the one that you alluded to is your newly diagnosed patients mainly in your first.

You have an extra formulation before we add another sector.

It's still small and you're going to want to make that investment and getting the most benefits over a long period of time and youre going to treat that patient with every two months dosing and again there is something there that we will continue to evaluate that we spoke about at the 18 months time point, which is that with every six months segments, we sell that the reduction.

And the lesion growth became better not linearly, but essentially the efficacy profile of the drug seem to improve over time, and we're going to see that's not a requirement for approval of course, but it is something that is very exciting when you think about treatments, thus far to cyber 10 years, especially for those early lesions. So we're going to find out what happens.

Between month 24, but if that trend from the first three segments continues that's something very exciting that I think we can then the extra.

Extra formulations early on newly diagnosed and making a long term investment with every other month dosing. We believe is very important.

And then, as it relates to the no ad com, so, you know, I believe from my understanding, that up to six weeks before the PDUFA date, you can have an ad com.

You know, I think that, you know, considering the very tight timelines that we have, that, of course, the longer time goes by, the less favorable time becomes to still organize an ad com.

Okay. If I can ask a follow up so yes.

Yeah, a lot of Kols, we've talked to are looking for continued improvement over time, we may be a separation of slopes.

<unk> segment data every six months.

But as far as expectations for 24 months.

Yes.

Somewhat downplayed, what we might be able to complete 24 months, but if there is no further separation do you think physicians will be motivated to continue to create long term.

Is this something that is that we have an idea of is it just theyre looking at sustainability or do they really want to continue its operations.

Yeah, No I think look if you.

<unk> continued to stay photoreceptor cells. The way, we believe you will even if that is the linear saving.

So if you stay around that.

20% or even a little bit below that.

For a reduction in the growth of geographic atrophy is based on the research that we did with the retinal community that is sufficient should we get.

And increased effect over time that would of course be.

Very exciting and something that we can then explore at that point in time.

And also we believe the requirements for adoption of this right.

Great. Thank you.

We'll pause for a moment while we compile our Q&A roster.

One moment for our next question.

Our first question comes from Madhu Kumar.

Our next question comes from Joseph Stringer with Needham Your line is open.

You're up for the Goldman Sachs.

Hi, This is been required on for Joe Thanks for taking my question.

Just a quick one you kind of mentioned a little bit about the payer mix I think I heard around 25% Medicare, but just the overall payer mix for you still.

Characterize that is relatively stable around 50, 50 or do you expect that trend to continue.

Thanks.

Thank you Lee I'm going to hand that over to.

Yes.

Yes, the majority of events of any payer rates, obviously commercial.

As we said before 25% in the.

A Medicare population.

And I think continue.

Okay, great. Thank you very much.

<unk> next question.

Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.

Your line is open.

Hey, everyone.

Thanks for taking our questions.

Hi, good afternoon, thanks for taking the questions and congrats on the progress just maybe as a follow up.

You made the comment about a lot of trying to start patients early especially with every other month dosing I'm. Just curious how do you think about providing guidance to clinicians about when the time might be appropriate to switch a patient from every other month dosing two monthly dosing.

So, I guess two from us.

Yes. Thank you so much thanks for the question so I think look.

There is.

There is a dose response.

Dose response is not like you get twice the benefit from doing.

Monthly injections from what you guys from every other month right. So.

So, the first one is a question we've been getting a lot, recently from investors is how to think about some of the disclosed ischemic optic neuropathy events that were mentioned in the Arvo presentation a few months ago.

But to your point, if you are a patient who has fulfilled encroachments, which means that's due to our knowledge at risk for losing central vision and specialty for already planned or <unk> business and the other REIT that is a strong motivator to extract as much efficacy as you can so that's something that we will continue to evaluate over time.

And again every other month for US is something that is very important competitively as well right I mean against kind of reiterate we have the first mover advantage every other month dosing we have data up to 18 months included in the sale and then we have patients with <unk> as well as extra folio lesions that are included.

And this profile. So it is something that we believe covers.

All populations that have this disease, whether it's early days, whether it's <unk> extra fulfilled and where we believe over the long run you can make a big difference in terms of saving photoreceptor cells.

And just as a follow up I'm just curious in the conversations with Kols.

Do they appreciate how much Bang for your Buck you get from every other month dosing.

Yes.

<unk>.

Yes, and it is something that we will continue to work hard on because we think thats I think thats up to this point quite frankly that has all been around whether its the safety profile looks like does the drug work or not.

I think we've really shown over time that it does work and it works well potentially worth better the longer you treat and that with every other month dosing youre close to probably in the range of 90% of the efficacy profile of monthly with half the number of injection that's not a part of the message that we focused on but something that we will focus on a lot.

And the most centers to come.

Okay, great. Thank you very much.

Thank you.

And I'm not showing any further questions at this time ill turn the call back over to Cedric for any remarks.

Thank you so much.

I'm not sure that you're all here for any remarks Patrick.

My closing remarks are not opening.

Closing.

Just want to thank all of you for joining we are really excited about the progress that we have made and what's ahead for us in September we will report to 24 month data.

And we will be around later today and tomorrow should you have any additional thank you again for joining us today.

They are wonderful the rest of them.

Ladies and gentlemen, this does conclude today's presentation you may now disconnect and have a wonderful.

The conference will begin shortly.

As Johan during Q&A, you can dial star one one.

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And so far, we have not received any indication that there would be one.

So, how are you guys thinking about ION, and how are you thinking about it in terms of kind of the ongoing review process for PEG and GA?

Ladies and gentlemen, thank you for standing by and welcome to the <unk>.

Second quarter 2022 earnings call at this time, all participants are in a listen only mode.

Second question we've been getting a lot of from investors, is how to think about the recently passed drug pricing reform as part of the Inflation Reduction Act that happened over the weekend.

How do you think that impacts a drug like PEG, Cetaclopan, that is largely biased towards patients on Medicare, kind of elderly patients, and has kind of like a big market opportunity framework?

Good afternoon, and thank you for joining us to discuss <unk> second quarter 2022 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 Christie, and Chief Financial Officer, Tim Sullivan.

Before we begin I would like to point out on slide three we will be making forward looking statements that are based on our current expectations and beliefs. These.

These statements are subject to certain risks and uncertainties and our actual results may differ materially.

I asked you to consult the risk factors discussed in our SEC filings for additional detail now I will turn the call over to Patrick.

I think it's also worth mentioning that the feedback that we gave as it relates to the, regulatory communication was done in writing and is to the best of our knowledge, of course.

So, any visibility on those two points, would be greatly appreciated.

Thank you all for joining us today.

Gotcha.

Thanks.

2022 is a transformational year at <unk>, and we are making great progress across each of our key priorities.

Thank you very much for the call there.

Thank you so much, Madhu, and great to hear you.

I will start with geographic atrophy or <unk>.

A few weeks ago, we were thrilled to announce that our NDA for <unk> was accepted by the FDA.

With a priority review designation and a <unk> date of November 26th 2022.

Next question.

So, first of all, on the ION cases.

The FDA also stated that it is not planning to hold an advisory committee meeting to discuss the application.

This is the best outcome, we could have hoped for and I am so proud of the equities team for their efforts in getting us to this pivotal point.

Our next question comes from Stephen Seathouse with Redmond James.

So, no assays for ischemic optic neuropathy, were reported between the 18 and the 24 month time point.

The NDA includes all available data from our Derby and Oaks studies out to 18 months and in the case of some patients even longer as well as the 12 month data from our <unk> study.

Collectively these data reinforce the potential for Brexit that group them to meaningfully slow disease progression and become the first ever treatment for the millions of patients living with GE.

Our relentless disease that is a leading cause of blindness worldwide.

We continue to work with the agency and our efforts to bring this therapy to patients who currently have no approved treatments.

In parallel we are also ramping up our commercial preparations. So that we are well positioned to bring <unk> to patients immediately upon potential approval.

In Europe , we are on track to submit our application to the EMEA by the end of this year.

We will include the 24 month data from Derby and Oaks in our submission, which we plan to report in September .

Your line is open.

So, as you may recall, between the two studies, we had one case between month six and 12 and two cases between month 12 and 18, where, again, the patients that were subjected to this also had kind of comorbidities that could explain why this happened.

J D will speak to this EBIT more in a few minutes.

Yeah.

But it's something that we continue to track, but we were very happy to see that it does not occur again and it's not something that we are concerned about at this point in time.

Turning to <unk>.

We remain focused on further establishing impacted at this first line treatment for patients living with <unk>.

Hi.

I'm going to hand it over to Adam to talk briefly, about the pricing.

We are seeing continued strength across a number of key indicators translating to $15 $7 million in U S. Net revenues towards the second quarter.

Thanks for taking the question.

Thanks for the question, Madhu.

Globally, our partner Sanofi is also making progress in bringing <unk> to patients with <unk>.

<unk> of the U S.

Beyond <unk>, we continue to advance <unk> as a transformative therapy for rare complements driven diseases.

Together with <unk>, we now have for later stage clinical programs underway.

We are also continuing to progress our early stage pipeline with Ind's plan for APL 2006, and our ESA R&D program in the first half of next year.

We are also continuing to advance our preclinical work with APL 10, 30 for potential use in neuro degenerative diseases, but no longer expect to submit the IND by the end of 2022.

So, obviously, we're monitoring this quite closely, but we believe the direct impact on Appellate's portfolio is currently pretty limited. And let me explain a little bit our thinking.

On the finance side, we ended the second quarter with approximately $850 million in cash providing runway into the first quarter of 2024.

This puts us in a uniquely strong position in this challenging market environment as we head into a potential launch later this year.

We look forward to building on our momentum as we further cements our position as a leader in <unk> across multiple therapeutic areas.

And with that I will turn it over to Adam.

Thank you Cedric.

So, let's start with Empavelli, right?

Turning to slide five we are now in our second year of commercial <unk> in the U S.

Cedric mentioned the commercial launch remains strong.

In the first year, we focused our efforts on the patients with the highest unmet need who are the one third of patients for the <unk> inhibitors, who require transfusions to address their falling hemoglobin levels.

We are continuing to see positive trends across the key leading indicators.

In the second quarter, approximately 30 start forms with generated bringing the total number of start forms since launch to approximately 190.

Over 75% of <unk> inhibitor patient switches are continuing to come from Altamira.

Okay 35, additional physicians, who are rems certified bringing the total since launch to greater than 200, we continue to see strong rems certification growth.

Which continues to be a key leading indicator as we move into the second year of launch.

Patient compliance rate remained high at 95% and we have established strong formulary access amongst the top 20 payers.

So, Empavelli, we don't think, can be subject to negotiation until 2030 at the earliest.

Now in the second year, we are heading into the next phase of our commercial strategy.

And even then, we think it's probably unlikely, that Medicare spending on the drug would be sufficient to result in CMS seeking to negotiate a price for the drug.

As a reminder, right, of our current sales, Medicare only represents 25% of the current business.

Which is expanding our focus to the broader pnas community by further positioning and potbelly.

Now, obviously, with future indications, and the extent of the Medicare spend, we've determined the likelihood of eligibility for inclusion or negotiation in the future.

First line treatment for all patients with <unk>.

We're refining our physician targeting so that we efficiently call on those prescribers, who are treating the majority of <unk> patients.

We're also advancing our outreach to key thought leaders, especially now that Doctor Hillman is fully on boarded.

In this next phase of launch we will evolve our partnerships with new centers to drive additional prescribers.

Sure that patients with <unk> have access to empirically.

Additionally, S NDA, including the phase III <unk> results and the 48 week Phase III Pegasus data was accepted with a <unk> date in February 2023.

If approved by the FDA this will allow us to strengthen our promotion of empathy for treatment naive patients and raise more awareness of our long term efficacy and safety data.

Just from a statistical analysis plan standpoint, when the FDA reviews the GA submission, is, the primary analysis 12-month in all three studies or 18 months in Derby and Oaks?

Now, if we move to GA and Intravitreal PEG, based on the most recent bill language, again, the drug would not be subject to negotiation until early 2030 at the earliest.

Now turning our attention to our progress in flight.

Slide six.

We are excited to be even closer to our anticipated approval and commercial launch in this critical area of high unmet need.

And just given the availability of the 18-month data in the filing, are you still sort of, needing to specify that Philly and Oaks are the two positive well-controlled studies, or do all three studies fit that criteria now?

Obviously, at the moment, we can't determine, the likelihood of negotiation until later in the 2020s, when we have some more data on the spending on PEG in GA and how that compares to other Medicare products.

G&A impact 5 million people worldwide, including 1 million people in the U S and.

What is interesting is, obviously, currently our composition of MAPSA patents for PEG expire in the early 2030s.

And I expect that the first approved therapy for this devastating disease.

Uncover even more patients.

Yeah.

So, even with a negotiated price potential, it would only really have an impact for two to three years until our IP hits.

Here at the palace, we are compelled by the potential to bring the first ever treatment to patients as quickly as possible and excited by the Fda's decision to grant <unk> trio <unk> Copeland.

Thank you so much, Steve.

Priority review designation.

We are eagerly awaiting on November could do for date and our team is focused on ensuring that we are well positioned for the launch we are ramping up our commercial capabilities with a key U S leadership positions already in place as well as additional key positions globally and much of the U S.

Field force is starting imminently.

Our focus prior to approval is on disease state awareness, specifically within the retinal community and amongst some of the broader <unk> group.

We are also advancing payer engagement to help us to secure a strong reimbursement and access post approval.

And we have established a retina advisory Council made up of several global opinion leaders to provide insights and advice as we prepare to bring <unk> to the market.

At launch our initial focus will be on the top 2600, retinal specialists and injecting ophthalmologists in the U S D.

Physicians in managing the vast majority of Gi patients currently.

We will expand our efforts over time to activating additional referral pathways to ensure that patients are being referred to the right physician treatment consideration.

We look forward to providing more granular details on launch preparation and execution as we closer to our Paducah date.

So, as I said at the beginning, I think at the moment, as we can see the bill, we believe the direct impact on the pellet and our portfolio is currently limited.

Let me now turn the call over to F&I.

Thank you Adam.

So the FDA does consider the primary analysis endpoint at 18 months in Derby and in Oaks.

The data from our Derby and Oaks studies.

To underscore the significant potential all bicephaly complement approach.

In Philly, of course, the treatment was up to 12 months.

First, could you clarify, and I know there has been a lot of confusion on this, could, you clarify any cases of vitreitis, uveitis, or ION in Phase 2 Philly trial that may not have been in the presentation?

Following the 18 month data reported in March we have shared additional analyses at key retina meetings.

And I think there's one case in Sham, for example, if you could speak to that.

We're enforcing that treatment with both monthly and every other month into retail folks at the Copeland and these studies demonstrated a clinically meaningful reduction in <unk> growth with a favorable safety profile.

And then secondly, folks listening in, I know there's been a lot of interest in understanding the profile on the clouding side for BofU from their Phase, 3 experience.

As highlighted on slide seven at ARVO in May.

So there it was at 12 months.

If you could speak to any observations along those lines from your data to date.

And I'm specifically referring to the occlusion scene in BofU, and if there's anything like, that.

<unk> data showing that treatment with Copeland continued to demonstrate a robust effect in patients with extra for the lesions and then improve the effect in patients with formulations as compared to what we observed in the 12 month results.

Thank you very much.

We also have a strong presence at macula Society in June .

Yeah, thank you so much, Umer, for that question.

This included data showing consistent reductions in GAA lithium growth in treated eyes basis and to the fellow eyes.

The compound also demonstrated sustained reductions in GAA lithium growth across all subgroups defined by increasing distances from the <unk> Center.

And just last month at the Srs.

<unk> analysis from Derby, and Oaks that showed the NIM rate or slope of GAA lesion growth at 18 months.

The results from this analysis were consistent what we have shown previously at 18 months. We then we'd all nominal P values for both dosing regimens below zero point real quick.

You correctly point out that it was very important for us to get an adjudication on Philly in, November last year.

So, in Philly, we had a case of ION in the Sham control in the untreated fellow eye as well.

And that's, as I already mentioned in the previous question, ION is something that does occur naturally in the elderly population, and it appears to be something that occurs more commonly when patients receive intravitreal injections, something that we know also from the patients that are on treatment with anti-vegetative.

Collectively all the data from Derby, and Oaks, and really reinforce the potential opex at the topline to slow the progression of GA across the disease spectrum, which is critically important given the <unk>.

Of these patient populations.

Also, the cases of vitreitis go hand in hand with the intraocular inflammation background that we have for this intravitreal administration of pexitacosine.

And the IOI cases that we have, first of all, on a qualitative basis, are different from what we see with BofU, where, you know, really the types of IOI that we had or that you have with that therapy can be very destructive to the eye.

We're excited to potentially bring the first ever therapy.

The profile that we have seen for the cases of inflammation are, first of all, qualitatively very low and in line with what you would expect from patients on intravitreal treatment, and also not of the kind that we are concerned about.

<unk> therapy to patients with <unk> with an opportunity to save as many photoreceptor cells as possible throughout the course of the disease.

You know, it gave us confidence and also allowed us to prepare the NDA, you know, really without, spending a lot of time trying to understand Derby and with the confidence that over time, Derby would catch up to the Oaks trial.

So we believe that the safety profile, you know, continues to be very favorable, and look forward to reporting 24-month data soon as well.

In September we plan to share top line results from Derby and Oaks at 24 months.

And that is what we saw happening at the 18-month data time point where, of course, the p-values flipped.

And Cedric, would you guys be able to speak to vision loss with any of these cases when, the 24-month data comes out?

As you May recall at 18 months, we presented full data showing that treatment with Brexit the Copeland resulted in increased efficacy.

Each six months intervals.

There are 266 to 12 and 12 to 18.

And we will continue to see what happens at the 24 months, whether that correction continues, to take place.

Okay, and then just quickly, for APL2006, what precisely is the indication or eligible, patient for that product?

We look forward to evaluating whether this improvement continue between months 18 to 22.

Is it just wet AMD?

Four.

So we are going to be talking about that more in the future, and for those on the call that, are not familiar with this product, this is something that combines an anti-VEGF with an anti-C3 active moiety in a single molecular entity.

If confirmed it could mean that the longer patients are on treatment the better the response to the drug.

So it will be something that we believe will become very valuable in the context of early, treatment, either for wet AMD or geographic accuracy, but how we are going to approach this from a regulatory development perspective remains to be determined.

This good compound in two very large condition price reductions over time.

Additionally, the secondary functional endpoints will be assessed at 24 months.

JA progression is correlated with loss of visual function over long periods of clients, meaning that reducing the rate of Gi lithium growth should eventually reduce the weight of vision loss.

As we have mentioned before and actually a doctor will suggest we do not expect to take the difference between the top line and Sham at 24 months due to the limitations of the functional endpoints in a relatively short period of time, although which they are being asked that.

We anticipate the separation.

Although longer periods of time.

We will include this 24 month data.

MAA.

We have had productive discussions with the <unk> to date and are on track to submit an EMA by the end of 2022.

Operators have shared with us that the EMA wants to understand the relationship between preserving visual function and reductions in Gi lesion growth.

We are confident in our ability to show. These based on published natural history studies and data from our phase III study.

All right, thanks very much for the question.

I don't want to put you on the spot right now.

And one moment for our next question.

Well, I mean, look, we will, of course, you know, elaborate more on the safety profile, including on, you know, what exactly the impacts of these cases are.

Our next question comes from Christopher Harriton with Jefferies.

Your line is open.

In May we dosed the first patient in our phase III study with Brexit the Copeland immune complex membrana pleasure craft, the drummer and Fridays.

Hi, Cain.

And PGN.

I would see particular neuropathy or CPG.

This is Kambi.

We also learned that the FDA granted orphan drug designation for <unk> for the treatment of IC and PGM.

This accumulation had previously been granted corporates that are Copeland for CPG.

The phase two study in hematopoietic stem cell transplant associated thrombotic microangiopathy or HFC DMA is actively enrolling patients.

Our partners Savi. It's currently screening patients in the phase III study in cold agglutinin disease or <unk>.

And has guided to now dosing the first patient in the second half of 2022.

And finally, we remain on track to report topline results potentially.

Potentially a registrational phase III study in <unk>.

Mid 2023.

He's on for Chris.

When exactly we will do that remains to be determined.

Let me now turn the call over to team for a review of the financials.

Maybe on kind of the infidelity label expansion opportunity, can you help us understand the, mechanistic differences between ICMPGN and C3G?

Tim.

What proportion of the post-transplant patients have recurrent disease, and do you expect, infidelity will perform as well in more severe patients as opposed to kind of more moderate patients?

So I'm not sure what's in the top line, unless it's considered meaningful.

Thank you Sir.

And then maybe as a second indication, for ALS, can you help us understand the CAFs score, endpoint and what will be important to demonstrate in terms of survival time and then in terms of ALS function rating score?

But definitely in the future, we'll talk more about that.

Since we issued a press release earlier today with the full financial results I will just focus on the highlights for the second quarter of 2022 summarized here on slide nine.

Thank you very much.

Thank you.

Thank you, Kambi.

One moment for our next question.

Total revenue was $16 3 million, which consisted of $15 7 million and <unk> net product revenue and $6 million in collaboration revenue from Tobey.

So on the C3G indication, so we kind of think about the C3G, and for that matter, the ICMPGN, population in kind of three buckets. The first one is newly diagnosed patients, typically adolescents, you know, still with, well-functioning kidneys, but with, of course, a path towards kidney failure.

The progression of the disease typically means that over the course of 10 years, half of, your patients will go into end-stage renal disease.

So that's, of course, you know, when you're in your teens, not a lot of time.

The second bucket of patients, therefore, are those that are having significant loss, of renal function, sometimes with nephrotic syndrome, and those are patients where efficacy becomes crucially important to avoid, of course, dialysis, or let alone transplantation.

And then to your point, the third category of patients are those that have been transplanted, and where recurrence, again, is something that occurs in more than half of the patients and something where we believe we can have an influence in avoiding that from happening.

Then as it relates to ALS, so the primary endpoint that we have there is the combined, assessment of function and survival.

Great.

Our next question comes from Andrew Pomerama with JPMorgan.

This is an endpoint that was discussed not just with the U.S. regulators, but also internationally, and the study is, it's a registrational phase two clinical trial, so, you know, it is properly powered should it have a positive readout to hopefully allow us to file in the various jurisdictions.

Thank you.

Your line is open.

R&D expenses were 102 million G&A expenses were $63 million and we reported a net loss of $156 million.

Hey, guys.

Thanks so much for taking the question, and congrats on all the progress, particularly on the GA side.

As of June 32020 to tell us at $853 million in cash cash equivalents and short term marketable securities.

We expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing <unk> launch the global launch of TEG, Cedar Coplin NGA and further development of our pipeline.

I wanted to ask a question on the 24-month Derby and Oaks coming on back of some of your opening comments.

We remain confident in the palaces financial future as we continue to execute on our upcoming milestones.

So in a note last week, we had that sort of Pecceda-Copeland preservation of trees relative to basin and or a couple-letter, relative to seabow as kind of a win scenario.

I will now turn the call back over to Cedric for closing remarks Cedric.

Where would you push back on this assessment?

Thank you Tim we.

We are excited about the many opportunities ahead.

Thank you so much, Anupam, for that question.

We look forward to continuing to share our progress as we build on the Companys momentum.

So we look forward to the 24-month data.

And maybe as one quick follow-up, is there any lessons you can learn from kind of the, systemic administration of epidemiology for ALS that you may be able to apply to your intrathecal neuro programs, or nothing there?

That is now open the call for questions operator.

Thanks again.

So it all comes down to seeing the correlation between the reduction in lesion growth and showing that you have safe photoreceptor cells and estimating how, in the long run, that will actually impact the functional endpoints.

Okay.

And that's my final question.

So we'll be working on that.

So we expect it to be in line between, at 24 months, not, show a difference yet, at least not statistical, and we believe that that will have no impact on the FDA-approved process.

Question or a comment at this time. Please press star one on your phone, we will pause for a moment, while we compile our Q&A roster.

Yeah, so I think, look, as many of you know, anti-C5 has failed before, when lutefamiris, was tested in patients with ALS, but we also all know that C3 does many things that C5 control does not do.

Thanks so much for taking our question.

Thank you.

I mean, we showed that very clearly, of course, in PNH, and it was the source of our approval, there with empavedi.

Our first question comes from Madhu Kumar Europe with Goldman Sachs. Your line is open.

We are now well north of 600 patient years of dosing with empavedi, and I think, you, know, and it's a point that we will be talking about more, is we haven't seen a single case so far of meningococcal infection, not one, whereas at this point in time, should he have been on a C5 inhibitor, it's probably reasonable to have expected in the range of three cases, if not more.

So that is something that, you know, we're very excited about.

And we'll move on to our next question.

I think it's a safety profile that is building as we get more patients on active, and something, that, should we have a positive result in ALS, or the other indications where we're testing, will, of course, be very beneficial as well.

Our next question comes from Tazina Med with Bank of America.

Hey, everyone. Thanks for taking our questions. So just two from US. So the first one is a question we've been getting a lot recently submitted investor is is how to think about some of the disclosed ischemic optic neuropathy events that were mentioned in the ARVO presentations a few months ago. So how are you guys thinking about ion and how you're thinking about in terms of kind of ongoing review process.

Your line is open.

Thank you.

Hi, guys.

One moment for our next question.

Good afternoon, and thanks for taking my question.

Our next question comes from Colleen Hefty with R.W.

As it relates to dosing frequency, is every other month still something that's realistically on the table, as far as your discussions with the agency?

For pegging GAA.

And do you think that physicians having flexibility to dose either once a month or once every other month is going to be important for commercial uptake?

Question, we've been getting a lot of from investors is how to think about the recently passed drug pricing reform as part of the inflation reduction act that happened over the weekend.

How do you think that impacts the drug like Craig said set a copay and that is largely bias towards patients on Medicare kind of elderly patients and has kind of like a big market opportunity framework. So any visibility on those two points we greatly appreciate it. Thanks.

And then secondly, can you just give us an update on where you are with ramping on the, commercial front in terms of hiring people and when they would be trained, and would you be ready to go on day one if you got approval in November?

Baird.

Thank you.

Thank you so much Netherlands, great to hear you. So first of all on the <unk>.

Your line is open.

Thank you so much, Tazi.

Hi, good afternoon, and thanks for taking our questions.

So not only is every other month on the table, it's a product, profile that we are very excited about.

<unk> cases.

As a follow-up to Steve's question earlier on the 18-month data, based on any feedback, you've received from the FDA, how do you see the 18-month data fitting in to the filing, I guess, specifically as it relates to the 12-month data?

No SaaS for ischemic optic neuropathy.

Between the 18 to 24 months standpoint, so as you may recall between the two studies, we had one case between month six and 12 two cases between months 12 and 18.

Well, I think that, thank you, Colleen, for that question.

So it was very important for us to include the 18-month data, right?

We're again divisions Thats were subjected to this also has kind of comorbidities that could explain why this happened.

But it's something that we continue to track, but we were very happy to see that.

It does not occur again, and it's not something that we are concerned about at this point in time.

So when we got the readout in September, and of course, the disappointment over narrowly, missing the primary endpoint in DERBY, we had two important strategic steps that we took.

I'm going to hand, it over to Adam just talk briefly about the pricing.

Thanks for the question, Matt. So obviously we are monitoring.

Quite closely but we believe the direct impact on our <unk> portfolio is currently pretty limited.

Finding a little bit thank.

So when you look at the efficacy profile that we reported at 18 months, and we'll see what happens at 24, you get a lot of the benefits, you know, maybe as much as 90% of the benefits with every other month injections, every other month treatment with half the number of injections, right?

<unk>, let's start with anybody right.

So something that is very exciting to us, something that we will continue to evaluate.

Antibody, we don't think can be subject to negotiation until 20, <unk>, yes I.

And even then we think its probably unlikely that Medicare spending on the drug would be sufficient to result in CMS seeking to negotiate a price for the drug.

To get to your point on the competitive profile, you know, we have several elements that position us favorably competitively as well.

As a reminder of our card sales Medicare only represent 25% of the card business now.

Now, obviously with future indications.

The Medicare spend we determined that the likelihood of eligibility for inclusion or negotiation in the future now as we move to <unk> and <unk>.

Based on the most recent bill language again, the drug would not be subject to negotiation until early 2000.

Yes.

Obviously at the moment, we can't determine the likelihood of negotiation until later in the 2010 2020 is when we have more data on the spending on peg NGA and how that compared to other Medicare products.

What is interesting is obviously currently our composition of matter patents for peg.

Buyer in the early 2013.

So even with the negotiated price potential it would only really have an impact for two to three years and so our IP is so.

As we as I said at the beginning I think Marlin equity you can see the bill we believe the direct impacts on a pallet that our portfolio is currently limited.

Great. Thanks for taking my questions.

And one of them are for our next question.

Our next question comes from Raimo <unk>.

With Evercore your line is open.

Hi, guys. Thanks for taking my questions, maybe a couple of them. If I may 1st could you clarify and I know theres been a lot of confusion on this could you clarify.

Any cases, they try this uveitis or ion in phase II filly trial that may not have been in the presentation and I think there's one case and Sham for example, if you could speak to that and then secondly.

Folks listening in I know theres been a lot of.

Interest and understanding.

The profile on the cloud side for Bellevue from their phase III experience. If you could speak to any observations along those lines from from your data to date.

Specifically, referring to the occlusions lean and VW and if there's any been anything like that thank you very much.

The first one was to get that adjudication in Philly that we got early November.

The second one was our decision in January to go to the FDA and to propose in our pre-MDA, meeting that we would include the full analysis for safety as well as efficacy all the way up to 18 months, hoping that there would be a catch-up of DERBY to OCHS.

Yes. Thank you. So much you refer that question. So in <unk>, we had a case of IOM and descent control, Indeed unseated fell away as well.

And that's as I already mentioned.

The previous question.

<unk> is something that does occur naturally.

An elderly population than we used to be something that occurs more commonly.

<unk> received an trended for the injections something that we know also from the.

Patients that arent treatment with anti digest.

Also the cases of detritus go hand in hand, with the intra ocular inflammation background that we have for this and traditional administration of fixes I called them and the cases that we have first of all on.

On a qualitative basis are different from what we see with <unk> with <unk>.

Same store NOI that we had or that you have with them.

Therapy.

Can be very destructive to the eye.

The profile that we have seen for the case sort of submission.

First of all quantitatively very low and in line with what you would expect from patients on <unk> treatment and also not all of the guidance that we were concerned about so we believe that the safety profile.

<unk> continues to be very favorable.

Look forward to reporting 24 months of investment as well.

And as you know, that is indeed what happened, right?

And Cedric would you guys be able to speak to vision loss with any of these cases when the 24 month data comes out I don't want to put you on the spot right now.

Okay.

Well I mean look we will of course elaborate more on the safety profile, including on.

What exactly the impact of these cases are.

When exactly we will do that remains to be determined so I'm not sure it will.

Top line unless it is considered meaningful.

But definitely in the future, we'll talk more about that.

Thank you.

One moment for our next question.

So the full data up to 18 months was submitted, and the primary endpoint interpretation was, very important with that 18-month data in mind.

Our next question comes from Andrew <unk> with Jpmorgan. Your line is open.

So I think it just creates a very complete picture for the FDA.

Yeah.

Hey, guys. So much for taking my question and congrats on all the progress, particularly on the G&A side.

I wanted to.

Ask a question on the 24th.

<unk>.

I think it was a good decision to do that.

On back of some of your opening comments so.

And of note last week.

Sort of Etsy to Copeland preservation slot.

Information.

Relative to basis, and or a couple letter bit relative thibault.

A win scenario where tobacco.

Thanks.

Thank you so much and upon further questions. So we look forward to the 24 month data.

In September as mentioned.

On the functional endpoints as we have always said we believe that.

Those endpoints, but.

But we know that those endpoints are not relevant to the FDA and the reason for that is that measuring functional endpoints.

It creates a very complete picture for the FDA.

I think it was a good decision to do that.

I'm not sure that answers your question, Colleen.

Difficult to do.

Very valuable and takes a long time to manifest itself on.

The baseline although when you are on treatment. So it all comes down to seeing the correlation between reduction in lesion growth and showing that your sales were to reset herself and estimating how in the long run that will actually impact.

The functional endpoint, so we will be working on that.

Yes.

So we expect it to be in line between at 24 months not show a difference yet.

These most statistical hence we believe that that will have though.

<unk>.

On the FDA process.

Yeah, great.

Thanks, so much for taking my question.

Thank you.

For next question.

And are there any avenues that you're aware of that the FDA has available to get feedback, from industry experts outside of a formal adcom?

Our next question comes from <unk> <unk> with Bank of America. Your line is open.

Or if there's no adcom, how should we assume there's kind of no interaction between the, FDA and the field during its review?

Yeah, so, look, I think with the ophthalmological division at the FDA, we have a very well-informed, and well-run division that has been stable for a very long time, right?

Hi, guys. Good afternoon, and thanks for taking my question.

The leadership there has been there for, I believe it's now three decades.

And I know for a fact, you know, that this is a division that has a very deep interaction, with the key opinion leaders in this field.

As it relates to dosing frequency is every other month still something thats realistically on the table as far as your discussions with the agency and do you think that physicians, having flexibility to dose either once a month or once every other month is going to be important for commercial uptake and then secondly can you just give us an update on where you are with.

Ramping on the commercial front in terms of.

Hiring people and when they would be trained and then would you be ready to go on day one.

In November thank you.

Thank you so much Doug.

So not only every other month on the table.

Product profile that we are very excited with us right. So.

When you look at the efficacy profile that we reported at 18 months and we'll see what happens in 'twenty four.

You get a lot of the benefits maybe as much as 90% of the benefits with every other month injections.

Every other month treatment was helped the number of injections right. So something that is very exciting to us is something that we will continue to evaluate.

To get to your point on the competitive profile.

Have several elements that position us favorably competitively as well first one of course again the ability to dose every two months secondly, the effects that we have reported all of the data to the FDA all the way up to 18 months, because I think a reasonable expectation that should we get approval.

The first one, of course, again, the ability to dose every two months.

Secondly, the fact that we have reported all of the data to the FDA all the way up to 18 months, with I think a reasonable expectation that should we get approval, that that will be included into the label.

We also have, of course, both foveal as well as extra foveal patients that were included to a broad patient population, all of which we look forward to talking about more.

It will be included into the label.

We also have of course, both <unk> as well as extra fulfilled patients that were included in a broad patient population.

All of which we look forward to talking about Mark.

I'm going to hand it over to Adam to talk briefly about what we are doing in terms of commercial prep.

I'm going to hand, it over to Adam talk briefly about what we are doing in terms of the commercial prep pay to Zane. It's Adam. Thank you for your question. So yes, we are.

Hey, Tehzeen, it's Adam.

We are ready to go we are starting to look for all of our field based teams prior.

So thank you for your question.

So yes, we are ready to go.

The last couple of months and we have now in the process of Onboarding all of that so quick step back prior to that.

Right.

We had high end the high level leadership roles within the U S. The high level of leadership roles within Europe and rest of world.

We started to look for all of our field-based teams prior over the last couple of months, and we are now in the process of onboarding all of them.

A huge amount of interest.

And people wanting to join a company, which is super exciting obviously, we are getting ready for our November <unk> date.

And the second part of your commercial ramping question was are we going to be ready.

At that time and the answer is absolutely not the plan I mean with a high unmet need NGA.

We're going to do everything we can to be ready.

Mediately post that Paducah date, so the teams.

Exactly where they need to be today.

Thank you.

One moment for our next question.

So a quick step back.

Yes.

Our next question comes from locally Lyla Youssef with Cowen Your line is open.

Prior to this great news, we had hired the high-level leadership roles within the U.S., the high-level leadership roles within Europe and the rest of the world.

And now we're going through all of the training process over the next couple of weeks to fully onboard the field-based teams from a medical affairs perspective and a market access perspective as well and any more sales and marketing people.

We had a huge amount of interest in people wanting to join our company, which is super exciting.

Obviously, we are getting ready for our November PDUFA date.

Alright, thanks, so much for taking the question and congrats on the progress maybe quickly on the European filing.

And the second part of your commercial ramping question was, are we going to be ready, at that time?

Against the Yankees.

Can you quickly clarify what else is outstanding.

The 24 month data for that is any component of that will be dependent on feedback from the FDA, although maybe at that.

So, you know, the reason why there was no adcom, I'm not going to speculate on.

We believe that the filing was straightforward based on the content that we submitted.

Question I appreciate that.

At currently but I think your understanding as well.

Well that's fine.

And switching to your line.

Tom.

Okay.

And it seems that they agree with us.

But we also know for a fact that there's lots of interactions that happen offline in this, very tight-knit community.

Okay.

Got it.

And the answer is absolutely.

Thank you so much for it.

It was limits Marvel's, but I believe that you asked about the European submission, including the 24 month data.

That makes sense.

That's our plan.

I mean, with a high unmet need in GA, we're going to do everything that we can to be ready immediately post that, PDUFA date.

So the teams are exactly where they need to be today.

Which is what we are indeed going to do and we plan to file before the end of the year.

Thank you.

I'm not sure whether you had a question more specific to them.

Yes.

If there is anything else that was of any heart youre waiting on feedback from the FDA that could help change that timing.

No. So this is not linked to feedback from the FDA, just including the 24 months.

And then as it relates to the no eskom so.

I believe from its my understanding that.

Up to six weeks before the <unk> UK.

You can have an outcome.

I think thats considering.

Considering this very tight timelines that we have that of course the longer.

Same goes by the less.

<unk> comes to still organized so far we have not received any indication that there would be one I think it's also worth mentioning that the feedback that we gave as it relates to the regulatory communication was both interesting and as to the best of our knowledge of course.

Okay. Thank you very much for the color.

Next question.

Thank you.

One moment for our next question.

Our next question comes from Stephen Suite helps with Raymond James Your line is open.

Yes, hi.

And last one for me.

Our next question comes from Leila Youssef with Cowen.

Just on the manufacturing part, of the filing you submitted, can you just make any high-level comments there and when the CMC inspections might occur?

Your line is open.

Thanks for taking the question.

Yes.

Hi.

But just from a statistical analysis plan standpoint, when the FDA reviews. The submission is the primary analysis 12 months in all three studies or 18 months in Derby and Oaks, and just given the availability of the 18 month data in the filing are you still.

Sort of needing to specify that affiliate Oaks or the two positive well controlled studies or do all three studies fit that criteria now.

Thanks so much for taking the question and congrats on the progress.

Yes. Thank you so much Steve so.

So, the manufacturing of the drug substance is the same as it is for Empavedi, right?

So it's Mexicacosa.

The FDA considers the primary analysis endpoint in 18 months in Derby and Oaks and video of course the team it was up to 12 months.

As you know, we got our approval for Empavedi without a single, 483 issued on either GCP or on manufacturing.

At 12 months.

We don't know if we will get inspections on the manufacturing side or not, but should we have any, we feel very comfortable that we will be able to come out of those positively.

Correctly pointed out that it was very important for us to get an adjudication on city in November last year.

Great.

Thanks for taking our questions.

One moment for our next question.

Thank you.

It gives us confidence and also allowed us to prepare the NDA.

Our next question comes from Derek Archila with Wells, Fargo.

And already without spending a lot of time trying to understand derby and with the confidence that overtime Derby with catch up to the <unk> trial and that is what we saw happening at the 18 month data growth quarters. The P values.

And we will continue to see what happens as to 24 months, whether thats <unk>.

Maybe quickly on the European filing expected by the end of the year, GA, can you quickly, clarify what else is outstanding besides the 24-month data for that?

Your line is open.

Is any component of that maybe dependent on feedback from the FDA?

Correction continues to take place.

Okay, and then just quickly for APL 2006, what precisely is the indication of our eligible patient for that product just wet AMD.

Hey.

Good afternoon, guys.

Thanks for taking the question.

So we are going to be talking about that more in the future for those on the call that are not familiar with this product. This is something that combines <unk> with an enticing three active moiety in a single molecular entity.

So it will be something that we believe will become very valuable in the context of early treatment.

Either for wet AMD or geographic as receive and how we are going to approach. This from a regulatory and development perspective remains to be determined.

Alright, thanks, very much for the questions.

One moment for our next question.

Just two from us.

Our next question comes from Christopher Howerton with Jefferies. Your line is open.

So first, I just wondered if, you know, has the FDA discussed with you any potential finding of either safety or efficacy from the 24-month data set that might prompt an outcome or require the 24-month data to be submitted as part of the review?

And then one question on P&H.

I guess, how are you tracking the plan, you know, in the launch?

Hi team this is <unk> on for Chris.

Maybe.

On kind of <unk> and fidelity label expansion opportunity can you help us understand the mechanistic differences between IC and PGN in CPG.

What proportion of these posts of the post transplant patients have recurrent disease.

And do you expect <unk> will perform as well in more severe patients.

The kind of more moderate patients.

And then maybe as a quick question, I appreciate that the FDA didn't request an adcom currently, but what is your kind of understanding of the last possible deadline that they would have to essentially change their mind and request an adcom given the timing of their current DUFA?

Thank you.

Thank you so much, Leila.

Thank you very much.

I guess, you know, what, are the major benefits of the inclusion of the 48, I guess, in the print data?

Thank you <unk> so on the <unk>.

<unk> indications, so we kind of think about the CPG and for that matter. The <unk> population and kind of three buckets. The first one is newly diagnosed patients typically at a lesson.

Still with well functioning kidneys, but with of course, a path towards kidney failure.

The progression of the disease typically means that over the course of 10 years half of your patients who will go into end stage renal disease.

So of course, when you and your teams not a lot of time.

The second bucket of patients. Therefore are those that are having significant loss of renal function, sometimes with nephrotic syndrome.

And something where we believe we can have.

And avoiding that from happening.

And then as it relates to this so the primary endpoint that we have there is a combined assessments of function and survival.

This is an end point that was discussed not just with the U S regulators, but also internationally.

And the study, it's a registrational phase two clinical trial.

So.

It is appropriately powers should it have a positive readouts to obviously loves to file in the various jurisdictions.

Great. Thank you and then one quick follow up is there any lessons you can learn from kind of a systemic administration.

At the valley for ALS, but you may be able to apply chair.

And critical neuro programs are.

Okay. Thanks, again, and that's my final question.

Yes, so I think look.

As many of you know and as you cite as Phil before when <unk> was tested in patients with ALS.

But we also all know that <unk>. There is many things that Steve five control personal to be show that very clearly of course <unk> that was the source of our approval there with <unk>. We are now well north of 600 patient years of dosing with <unk> and I think.

With the point that we will be talking about more is we haven't seen a single case, so far of Meningococcall infection, not one whereas at this point in time Shouldnt have been on the C. Five inhibitor, it's probably reasonable to unexpected in the range of three cases, if not more so that is something that we have.

Very excited about the safety profile that is building as we get more patients on <unk>.

And <unk>.

Something that should we have a positive result.

The other indications, where we're testing both of course defended very beneficial as well.

Thank you one moment for our next question.

Our next question comes from Carlos <unk> with RW Baird. Your line is open.

Hi, good afternoon, and thanks for taking our question as a follow up to Steve's question earlier on the 18 month data.

Based on any feedback you've received from the FDA. How did you see the 18 months data sitting in the filing I guess, specifically as it relates to the 12 month data.

I think thats. Thank you calling for that question.

It was very important for us to include the 18 month data. So when we got the readout in September and of course, the disappointments over narrowly missing the primary end point in Derby.

I'm not sure whether you had a question more specific to that.

We had two important strategic steps that we took the first one was to get that adjudication in Sealy that we got the early November the second one was our decision in January to go to the FDA and to propose in our pre NDA meeting that we would include the full analysis for safety as well as efficacy all the way up to <unk>.

Oh, yeah.

If there is anything else that was outstanding or if you're waiting on feedback from the, FDA that could help change that timing?

No.

So this is not linked to feedback from the FDA, it's just including the 24-month data.

18 months, hoping that there would be a catch up of derby to folks and as you know that is indeed, what happened right. So.

Data up to 18 months was submitted and primary endpoints interpretation was very important with an 18 month payback in mind, So I think.

<unk> creates.

A complete picture for the FDA.

I think it was a good decision too.

To do that.

It's a very complete picture for the FDA.

I think it was a good decision.

To do that.

Im not sure that answers your question Cody.

And then as it relates to the no adcom, so, you know, I believe from my understanding, that up to six weeks before the DUFA date, you can have an adcom.

Great. Thank you and are there any avenues that youre aware of that the FDA has available to get feedback from industry experts outside of a formal AD com or if there is no outcome health should we assume there is no interaction between the FDA and the field during its review.

You know, I think that considering the very tight timelines that we have, that of course, the longer time goes by, the less favorable time becomes to still organize an adcom.

And so far, we have not received any indication that there would be one.

I think it's also worth mentioning that feedback that we gave as it relates to the regulatory, communication was done in writing and is to the best of our knowledge, of course.

Thank you very much for the color.

Yes so.

Look I think.

With Youll, some electrical division at FDA.

Very well informed and well run division that has been stable for a very long time right. The leadership there has been there before.

I believe it's now three decades.

And I know for effect that this is a decision that has a very deep interaction with key opinion leaders in this field. So.

The reason why there was no <unk> im not going to speculate on.

We believe that this filing was straightforward based on the content that we submitted.

It seems that they agree with us.

But we also know for our sector theres lots of interactions that happen offline and this great community.

Yes.

So manufacturing of the drug substance is the same as it is for <unk>, but any retrospective that call them.

As you know, we got our approval for <unk> that even without a single 483 issues on that.

GPU on manufacturing.

We don't know if we will get inspections on the manufacturing side or not but should we have any we feel very comfortable that we will be able to move to.

To come out of those positives.

Great. Thanks for taking our questions.

Thank you.

One moment for our next question.

We'll go to the next question.

Our next question comes from Steven Seathouse with Redmond James.

Our next question comes from Derek <unk> with Wells Fargo. Your line is open.

Your line is open.

Hey, good afternoon, guys. Thanks for taking the question just two costs.

First I was wondering if as the FDA discuss with you.

You'll find either safety or efficacy.

For marketing and done that might prompt an ad com where required.

Like, what issue is that addressing, you know, in the launch thing?

Four month data to be submitted as part of the review.

One question on <unk> I guess, how are you tracking the plan and the launch I guess.

What are the major benefit of the inclusion of the 48.

Thank you, Derek.

Steve.

Was that a threatening launch thanks.

Thank you Derek I will handover to the teenage question to Adam.

As it relates to the 24 month data I think it's important to note that we don't expect any surprises between 18 to 24 months. So we believe to see an extension of both the efficacy as well as the safety profile as it was established at 18 months.

That is the way you look at it and Thats the way we look at it.

<unk>.

Of course should something unexpected emerge at that point in time, it's hard to know what's what actions should be required or what we would do but that is something that we believe will be the case.

I will hand over the P&H question to Adam.

And then for <unk> I will hand, it over to Adam.

But as it relates to the, 24-month data, I think it's important to note that we don't expect any surprises between 18 and 24 months, right?

Thanks, Eric.

Obviously, we are entering year two of our option internally, we've now pivoted our strategy, what we call phase III right well, it's starting to target new sensors, and new physicians and continue to drive those sources of demand.

Talking about start forms and switches from <unk>, five rems certifications et cetera.

So we believe to see an extension of both the efficacy as well, as the safety profile as it was established at 18 months.

The 48 week and print.

<unk> really solidifies.

First slide treatment of choice for PMA trial, the more data that we have in the label the more robust conversations we can have with physicians.

Long term efficacy and safety, but also on treatment naive, we're making a really good inroads with treatment naive patients and I'll give you a little insight.

Inside our July Stockholm over a third of our July start forms were treatment naive patients. We continued to see growth as physicians start to broaden that use.

From those with the highest unmet need.

Larger and broader PMA ICH patients and treatment naive patients. So I expect to see a continued to progress and accelerate as we enter the next phase of our launch so that's how the precise from the 48 week Pegasus data help us out.

Great. Thanks, so much for answering the questions.

And one enrollment for next question.

Yeah.

Our next question comes from Justin Kim with Oppenheimer. Your line is open.

Hi.

Good afternoon, and thanks for taking the question just maybe one question from us.

I know that the 24 month data may not be sort of that point, where you can see separation on visual acuity, but how should we think about Gail.

And sort of that sort of duration of treatment as you combine it with potentially Caribbean.

Is that something that could show, maybe that hinder trend or separation just wondering.

How we should think about that study.

Thanks for taking the question.

Yes. Thank you very much for the question Justin So Gail is something that we are incredibly excited and happy with threat. So for those not familiar with that its three year extension on the patients from Derby and Oaks that we then enroll.

To continue to monitor.

<unk> function and how a decent size reduction is that the safety profile of themselves over time, and it's also something that's very important to us competitively.

Just from a statistical analysis plan standpoint, when the FDA reviews the GA submission, is, the primary analysis 12-month in all three studies or 18 months in Derby and Oaks?

We have every other month dosing, we have our first mover advantage we are facing this.

This filing.

Both types of patients with the <unk> extra mobile patients and then again the ability to looking Gail as to what happens in the long run.

Something very important to us.

We will talk about in the years to come.

Great. Thanks, so much.

Thank you.

One moment for our next question.

So I think that is the way the FDA looked at it.

And just given the availability of the 18-month data in the filing, are you still sort of, needing to specify that Philly and Oaks are the two positive well-controlled studies or do all three studies fit that criteria now?

Second comes from Dugald Ghansham brisk with Citi. Your line is open.

That's the way we look at it.

You know, of course, you know, should, something unexpected emerge at that point in time, it's hard to know what action should be required or what we would do.

Hi, great. Thanks for taking the question I think better Rico, you said that the EMA wanted to see the relation between preserving visual function and lesion growth.

Could you just expand a little bit on what data, specifically youre going to leverage to make this point to EMA. Since you said that the 21 to 24 month update we won't be sufficient to show the separation on the functional endpoints.

But that's not something that we believe will be the case.

Yeah.

Thank you for your question so.

<unk>.

Although referred to the 24 months.

Not being something significant doesn't mean that may not be sufficient to show <unk>.

And some of the data so we're going to look.

Look at what we get from the study in addition to that all the natural history data to find the relationships between the functional endpoints.

Alright between that ophthalmic endpoints.

Function that none there probably may come from central visual acuity, which is hard to measure so.

To be doing a little more investigation of the data in the study.

Do you see what correlations we get.

And then for P&H, I will hand it over to Adam.

Thank you so much, Steve.

Okay. Thanks, and then just Adam could you just tell us if you could what percent of the <unk> market you believe you've captured so far in the U S.

Thanks, Derek.

So, the FDA does consider the primary analysis endpoint at 18 months in Derby and in Oaks.

Yes, so obviously we're entering year two of our launch, and internally, we've now pivoted to strategy, what we call phase two, right, where we're starting to target new centers and new physicians and continue to drive those sources of demand.

In Philly, of course, the treatment was up to 12 months, so there it was at 12 months.

You correctly point out that it was very important to us to get an adjudication on Philly in, November last year.

Yes.

So obviously, we think there are 1500 <unk> five treated patients.

We have over 200 thoughtful of approximately 190 to 200 stockholders. So that should give you a good.

Hint of how the progress that we're making.

And we'll keep talking about staff forms and switches from C5s and REM certifications, et cetera.

That is what we saw happening at the 18-month data time point where, of course, the p-values, flipped.

As we got we obviously don't give guidance on revenue or anything along those lines.

With over 200, Rems certified physicians and start forms continue to come in and we think we're really.

Making good progress in converting C. Five patients starting treatment naive patients with <unk>.

And we will continue to see what happens at the 24 months, whether that correction continues, to take place.

Okay. Thank you.

Yes.

One moment for our next question.

The 48-week print date just really solidifies our first-line treatment of choice for P&H, right?

Okay, and then just quickly, for APL2006, what precisely is the indication or eligible, patient for that product?

Our next question comes from Ellie Merle with UBS. Your line is open.

The more data that we can have in the label, the more robust conversations we can have with physicians on the long-term efficacy and safety, but also on treatment naive.

Is it just wet AMD?

Hey, guys. Thanks, so much for taking my question just first on the Io and can you just elaborate on the cases that we're seeing I guess, how the patients presented and how they were managed.

We're making a really good inroads with treatment naive patients, and I'll give you a little insight. Our July staff forms, over a third of our July staff forms were treatment naive patients.

We continue to see growth as physicians start to broaden their use from those with the highest unmet need to those larger and broader P&H patients and treatment naive patients.

So I expect to see that continue to progress and accelerate as we enter the next phase of our launch.

So that's how the print date and the 48-week, Pegasus data help us.

It was resolved and then also specifically I think.

Great.

Thanks so much for answering the question.

And one of the first question from Macquarie You mentioned.

Comorbidities application Todd if you could just kind of elaborate on.

Maybe why this.

Non truck related in those cases.

And then just second question just in terms of thinking about the overall potential duration of use that as my bad Guy in the cases.

That explanation, maybe just how youre thinking about that and how long anti that Jeff. Thank you.

Keith and I guess, if there's any data that we can expect that just from the 24 month data or thinking about sort of a longer term study about the management of the nuance that excavations and thinking about the duration of use of anti that Jeff. Thanks.

All right, thanks very much for the question.

Thank you.

IOM cases, the detail is not something we're going to talk about on this call.

First an enforcement point was to find out is this is <unk>.

They're becoming worse over time right I mean, we had one from six to 12 and then two from 12 to 18. There was of course I think your rightful considerations is going to be comverse or another and it did so we didn't have a single additional kit.

Now as it relates to the.

Two these are real world evidence for the non did you also expositions.

Yes.

<unk> studies when patients have nuance in expedition, they get treated with anti VEGF on regular puzzle.

At the end of the three year time period.

We have one prs that what does that mean people stop receiving advantages and then we find out how long does it take for these patients.

And we compare that between axis.

And the sham controls, so thats going to be interesting piece of information on which we will have more information next.

Next year as well so deals in person there again to find those.

What that means how dependent patients are going to be honest that adjust but I can tell you that in this study is to combine the administration of anti VEGF and fixes that cobalt has not being an issue.

Great. Thanks for the color.

Thank you.

And one moment for our next question.

One moment for our next question.

Our next question comes from Justin Kim with Oppenheimer.

Our next question comes from Christopher Harrington with Jefferies.

Our next question comes from Annabel <unk> with Stifel. Your line is open.

Your line is open.

Hi.

Hi, Cain.

Hi, Thanks for taking my question.

Good afternoon and thanks for taking the question.

So I realize that we're constantly cleaning the carpet final court, but you're studying <unk> in a range of severities.

Just maybe one question from us.

So how do you envision a freshness market now it's clear from the data that the earlier the better but clearly the most desperate or the patient services.

Alright, and maybe getting relief benefit. So how are you initially going to be targeting this market as you as you as you entered the market.

This is Kambi's on for Chris.

I had a hard time hearing you.

Okay.

Hello, Yes, sorry.

Sorry, yes, sorry, yes.

But Tim was that or hearing that maybe just to clarify this further.

Maybe on kind of the infidelity label expansion opportunity, can you help us understand the, mechanistic differences between ICMPGN and C3G?

What proportion of the post-transplant patients have recurrent disease, and do you expect, the infidelity will perform as well in more severe patients as opposed to kind of more moderate patients?

I think again one of the very exciting version of our data set is that every other month.

With <unk> the number of injections seems to give you close to probably 90% of the benefit in terms of slowing down the progression of.

Geographic atrophy, so that fits very nicely with the product profile.

Theres, many product profiles, but two that stand out as being particularly attractive one is the other patients with muscle vision in one eye and wants to save as much business as possible in the fell away.

Those are patients that probably youre going to want to treat as aggressively as possible <unk> monthly dosing, but then the other one the one that you alluded to is you're a newly diagnosed patient imagine your first.

You have an extra <unk> <unk> is not affected.

It's still small and you're going to want to make that investment and getting the most benefits over a long period of time and youre going to treat that patient with every two months dosing and again there is something there that we will continue to evaluate that we spoke about 18 months time point, which is that with every six months segments, we sell that the reduction.

And the lesion growth became better not linearly, but essentially the efficacy profile of the drug seems to improve over time and we're going to see that's not a requirement for approval of course, but it is something that is very exciting when you think about treatments, thus far to cyber 10 years, especially for those early vision. So we're going to find out what happens to be.

Between month 24, but if that trend from the first three segments continues that's something very exciting that I think we can then the extra.

Except for the lesions early on newly diagnosed and making a long term investment with every other month dosing. We believe is very important.

Okay. If I can ask a follow up so yeah.

A lot of Kols with top two are looking for continued improvement over time and maybe separation of slopes.

These shut in the segment data every six months.

You know, I know that the 24-month data may not be sort of that point where you can see separation on visual acuity.

But, you know, how should we think about gale and sort of that sort of duration of treatment as you combine it with potentially derby and nose?

As far as expectations for 24 months.

Yes.

Somewhat downplayed, what we might be able to say 24 months, but if there is no. Further separation do you think physicians will be motivated to continue to create long term.

Is that something, you know, that could show maybe that hint or trend or separation?

Is this something that is that we have an idea is it just.

Theyre looking at sustainability or do they really want to continue.

Just wondering, you know, how we should think about that study.

Yeah.

Yeah, No I think look if you continue to stay photoreceptor cells. The way. We believe you will even if that is the linear saving.

As you say.

Around that 20% or even a little bit below that.

For a reduction in the growth of geographic atrophy based on the research that we did with the retinal community that is sufficient should we get.

And increased effect over time that would be great.

Very exciting and something that we can then explore investment in Texas.

And also we believe the requirements for adoption of this right.

Great. Thank you.

One moment for our next question.

Thank you very much for that question, Justin.

Our next question comes from Joseph Stringer with Needham Your line is open.

So gale is something that we are incredibly excited and happy with, right?

So for those not familiar with that, it's a three-year extension on the basis from derby and oaks that we then enroll to continue to monitor how function and how lesion size reductions and safety profile themselves over time.

It's also something that's very important to us competitively.

You know, again, we have every other month dosing.

Hi, This is been required on for Joe Thanks for taking my question.

We have our first mover advantage. We have 18-month data and the filing includes all types of patients with foveal as well as extra foveal patients.

And then, again, the ability to look in gale as to what happens in the long run.

Great.

So it's something very important to us that we will talk about in the years to come.

Just a quick one you kind of mentioned a little bit about the improved payor mix I think I heard around 25% Medicare, but just the overall payer mix would you still characterize that as relatively stable around 50, 50 or do you expect that trend to continue.

Thanks so much.

Thank you.

Thanks.

Thank you Lee I'm going to hand that over to.

Yes.

Yes, the majority of any payer rates, obviously commercial.

As we said before 25% in the Medicare population.

I expect that to continue.

Great. Thank you very much remember for next question.

One moment for our next question.

One second.

Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.

It comes from Griswood City.

Your line is open.

Oh, hi.

Hi, good afternoon, thanks for taking the questions and congrats on the progress <unk> made.

And then maybe as a second indication, for ALS, can you help us understand the CAFT score, and point, and what will be important to demonstrate in terms of survival time, and then in terms of ALS function rating score?

Maybe as a follow up.

Great.

Thank you very much.

Thanks for taking the question.

Thank you, Kambi.

I think, Federico, you said that the EMA wanted to see the relation between preserving visual function and lesion growth.

Yes. Thank you so much thanks for the question So I think Luke.

So could you just expand a little bit on what data specifically you're going to leverage to make this point to EMA since you said that the 24-month update won't be available?

The progression of the disease typically means that over the course of 10 years, half of, your patients will go into end-stage renal disease.

So that's, of course, you know, when you're in your teens, not a lot of time.

There is.

Could you just expand a little bit on what data specifically you're going to leverage to make this point to EMA since you said that the 24-month update won't be sufficient to show the separation on the functional endpoints?

There is a dose response.

That dose response is not like you get twice the benefit from doing the monthly injections from what you guys from every other month right. So.

And then to your point, the third category of patients are those that have been transplanted, and where recurrence, again, is something that occurs in more than half of the patients, and something where we believe we can have an influence in avoiding that from happening.

Then as it relates to ALS, so the primary endpoint that we have there is a combined, assessment of function and survival.

But to your point, if you are a patient who has fulfilled encroachments, which means that's due to our knowledge risk for losing central vision and specialty for already planned or above business than the other right that is a strong motivator to extract as much efficacy as you can so thats something that we will continue to evaluate that over time.

And again every other month for US is something that is very important competitively as well right I mean against kind of reiterate we have the first mover advantage.

This is an endpoint that was discussed not just with the U.S. regulators, but also internationally, and the study is a registration of Phase II clinical trial, so, you know, it is properly powered should it have a positive readout to hopefully allow us to file in the various jurisdictions.

The other monthly dosing, we have data up to 18 months included in the sale and then we have patients with <unk> as well as extra fulfilled lesions that are included.

Great, thank you.

And maybe as one quick follow-up, is there any lessons you can learn from kind of the, systemic administration of epidemiology for ALS that you may be able to apply to your, N50 COLE neuro programs, or nothing there?

And this profile. So it is something that we believe covers all populations that have this disease, whether it's early days, whether it's <unk> extra fulfilled and where we believe over the long run you can make a big difference in terms of saving photoreceptor cells.

Thanks again.

And that's my final.

And just as a follow up I'm just curious in the conversations with Kols.

Do they appreciate how much Bang for your Buck you get from every other month dosing.

Yeah, so I think, look, as many of you know, anti-C5 has failed before, when lutefemiris, was tested in patients with ALS, but we also all know that C3 does many things that C5 control does not do.

I mean, we've shown that very clearly, of course, in PNH, and it was the source of our, approval there with empavedi.

Yes.

It's something that we will continue to work hard on because we think Thats I think thats up to this point quite frankly has all been around whether its the safety profile looks like does the drug work or not.

We are now well north of 600 patient years of dosing with empavedi, and I think, you, know, and it's a point that we will be talking about more, is we haven't seen a single case so far of meningococcal infection, not one, whereas at this point in time, should you have been on a C5 inhibitor, it's probably reasonable to have expected in the range of three cases, if not more.

I think we've clearly shown over time that it does work and it works well may potentially worth better the longer you treat and that with every other month dosing youre close to probably in the range of 90% of the efficacy profile of monthly withheld the number of injection that's not a part of the message that we focused on but something that we will focus on a lot.

As amongst centers to come.

Okay, great. Thank you very much.

Thanks.

Thank you.

And I'm not showing any further questions at this time I'd like to turn the call back over to Cedric for any remarks.

Thank you so much.

I'm not sure did you all hear that for any remarks metrics.

My closing remarks are not opening.

Thank you for the question.

At closing.

Just want to thank all of you for joining we are really excited about the progress that we have made and what's ahead for us in September when we will report to 24 months data.

So that is something that, you know, we're very excited about.

Thank you.

One moment for our next question.

And we will be around later today and tomorrow should you have any additional thank you again for joining us today.

Our next question comes from Colleen Kessie with RW Bayer.

Your line is open.

Hi, good afternoon, and thanks for taking our questions.

They are wonderful the rest of them.

So when we refer to the 24 months not being something significant, that does mean that it may not be sufficient to show trends on the data.

I think that, thank you, Colleen, for that question.

Well, ladies and gentlemen, this concludes today's presentation.

So it was very important for us to include the 18-month data, right?

Ladies and gentlemen, this does conclude today's presentation you may now disconnect and have a wonderful.

So when we got the readout in September, and, of course, the disappointment over narrowly, missing the primary endpoint in Derby, we had two important strategic steps that we took.

The first one was to get that adjudication in Philly that we got early November.

And as you know, that is indeed what happened, right?

So the full data up to 18 months was submitted, and the primary endpoint interpretation was, very important to put that 18-month data in mind.

So I think it just creates a very complete picture for the FDA.

I think it was a good decision to do that.

I'm not sure that answers your question, Colleen.

Yep.

Great.

Thank you.

And are there any avenues that you're aware of that the FDA has available to get feedback, from industry experts outside of a formal ADCOMM?

Or if there's no ADCOMM, how should we assume there's kind of no interaction between the, FDA and the field during its review?

I think that's a good question.

How should we assume there's kind of no interaction between the FDA and the field during its review?

Yeah.

So, look, I think with the ophthalmological division at the FDA, we have a very well-informed, and well-run division that has been stable for a very long time, right? The leadership there has been there for, I believe it's now three decades.

And I know for a fact, you know, that this is a division that has a very deep interaction, with the key opinion leaders in this field.

So, you know, the reason why there was no ADCOMM, I'm not going to speculate on.

We believe that the filing was straightforward based on the content that we submitted.

And it seems that they agree with us.

But we also know for a fact that there's lots of interactions that happen offline in this, very tight-knit community.

Got it.

That makes sense.

Thank you.

And last one for me.

Just on the manufacturing part, of the filing you submitted, can you just make any high-level comments there and when the CMC inspections might occur?

Yeah.

So the manufacturing of the drug substance is the same as it is for Empavedi, right?

So it's fix-it-I-call-them.

As you know, we got our approval for Empavedi without a, single 483 issued on either GCP or on manufacturing.

We don't know if we will get inspections on the manufacturing side or not, but should we have any, we feel very comfortable that we will be able to come out of those positively.

Great.

Thanks for taking our questions.

Thank you.

One moment for our next question.

Our next question comes from Derek Archela with Wells Fargo.

Your line is open.

Hey.

Good afternoon, guys.

Thanks for taking the question.

Just two for us.

So first, I, just wondered if, you know, has the FDA discussed with you any potential findings, either safety or efficacy, from the 24-month data set that might prompt an ADCOM or require the 24-month data to be submitted as part of the review?

And then one question on P&H.

I guess, how are you tracking the plan, you know, in the, launch, and I guess, you know, what are the major benefits of the inclusion of the 48 Pegasus in the print data?

Like, what issue is that addressing, you know, in the launch, thing?

Thank you, Derek.

I will hand over the P&H question to Adam.

But as it relates to the, 24-month data, I think it's important to note that we don't expect any surprises between 18 and 24 months, right?

So we believe to see an extension of both the efficacy as well, as the safety profile as it was established at 18 months.

So I think that is the way the FDA looked at it.

That's the way we look at it.

You know, of course, you know, should, something unexpected emerge at that point in time, it's hard to know what action should be required or what we would do, but that's not something that we believe will be the case.

And then for P&H, I will hand it over to Adam.

Thanks, Derek.

Yes, so obviously, we're entering year two of our launch, and internally, we've, now pivoted to strategy, what we call phase two, right, where we're starting to target new centers and new physicians and continue to drive those sources of demand.

And we'll be talking about start forms and switches from Z5s and REM certifications, et cetera.

The 48-week and print date just really solidifies our first-line treatment of choice for P&H, right?

The more data that we can have in the label, the more robust conversations we can have with physicians on the long-term efficacy and safety, but also on treatment naive.

We're making a really good inroads with treatment naive patients, and I'll give you a little, insight.

Our July start form, over a third of our July start forms were treatment naive patients.

We continue to see growth as physicians start to broaden their use from those with the highest unmet need to those larger and broader P&H patients and treatment naive patients, and I expect to see that continue to progress and accelerate as we enter the next phase of our launch.

So that's how the print data and the 48-week Pegasus data help us out.

Great.

Thanks so much for answering the question.

And one moment for our next question.

Our next question comes from Justin Kim with Oppenheimer.

Your line is open.

Hi.

Good afternoon and thanks for taking the question.

Just maybe one question from us.

You know, I know that the 24-month data may not be sort of that point where you can see separation on visual acuity.

But, you know, how should we think about gale and sort of that sort of duration of treatment as you combine it with potentially derby and note?

Is that something, you know, that could show maybe that hint or trend or separation?

Just wondering, you know, how we should think about that study.

Yeah.

Thank you very much for that question, Justin.

So gale is something that we are incredibly excited and happy with, right?

So for those not familiar with that, it's a three-year extension on the patients from derby and oaks that we then enroll to continue to monitor how function and how lesion size reductions and safety profile themselves over time.

It's also something that's very important to us competitively.

You know, again, we have every other month posting.

We have our first mover advantage. We have 18-month data and the filing. It includes all types of patients with foveal as well as extra foveal patients.

And then, again, the ability to look in gale as to what happens in the long run.

So it's something very important to us that we will talk about in the years to come.

Great.

Thanks so much.

Thank you.

One moment for our next question.

Our next question comes from Iago.

Your line is open.

Oh, hi.

Great.

Thanks for taking the question.

I think, Federico, you said that the EMA wanted to see the relation between preserving visual function and lesion growth.

So could you just expand a little bit on what data specifically you're going to leverage to make this point to EMA since you said that the 24-month update won't be available until the end of the year? Or that the 24-month update won't be sufficient to show the separation on the functional endpoints?

Thanks.

Thank you for the question.

So when we refer to the 24 months not being something significant, that does mean that it may not be sufficient to show trends on the data.

So we're going to look at what we get from the study and, in addition to that, all the natural history data to find the relationship between the functional endpoints, sorry, between the anatomical endpoints and function that not necessarily may come from central visual acuity, which is hard to measure.

So we're going to be doing a little more investigation on the data in the study to see what correlations we get.

Okay, thanks.

And then, Adam, could you just tell us, if you could, what percent of the PNH market you believe you've captured so far in the U.S.?

Yes, so thanks, Miguel.

So, obviously, we think there are 1,500 T5-treated patients, and we have over 200 start forms, approximately 190 to 200 start forms.

So that should give you a good hint of how, of the progress that we're making as we go.

We obviously don't give guidance on revenue or anything along those lines.

But with over 200 REM-certified physicians and start forms continue to come in, we think we're really making good progress in converting T5 patients and starting treatment in IE patients within PNH.

Okay, thank you.

One moment for our next question.

Our next question comes from Ellie Merle with UBS.

Your line is open.

Hey, guys.

Thanks so much for taking the question.

Just first on the ION, can you just elaborate on the cases that were seen?

I guess how the patients presented and how they were managed and, I guess, if it was resolved.

And then also specifically, I think, in one of the first questions on the call, you mentioned some comorbidities that the patients had.

If you could just kind of elaborate on this and maybe why this sort of leads you to think that this was not drug-related in those cases seen.

And then just second question, just in terms of thinking about the real-world potential duration of use of anti-VEGF in the cases of sort of new onset exudation.

Maybe just, you know, how you're thinking about that and, you know, how long anti-VEGF might be used in those cases.

And I guess if there's any data that we can expect, such as from the 24-month data or, you know, in thinking about sort of the longer-term Yale study about sort of the management of the new onset exudations and thinking about the duration of use of the anti-VEGF.

Thanks.

Thank you.

So on the ION cases, you know, the details is not something we're going to talk about on this call.

I think the first and important point was to find out if these SAEs, you know, were becoming worse over time.

Right.

I mean, we had one from 6 to 12 and two from 12 to 18.

You know, there was, of course, I think a rightful consideration that it's going to become worse or not.

And it didn't.

Right.

So we didn't have a single additional case.

Now, as it relates to the real-world evidence for the new onset exudations, the Derby and Oak studies, when patients have new onset exudations, they get treated with anti-VEGF on regular pathology.

At the end of the two-year time period, we have one PRN step.

What does that mean?

People stop receiving anti-VEGF.

And then we find out how long does it take for these patients to leak again?

And we compare that between active and the sham control.

So that's going to be an interesting piece of information on which we will have more information next year as well.

So it feels important there again to find out what that means, how dependent patients are going to be on anti-VEGF.

But I can tell you that in the studies, the combined administration of anti-VEGF and Plexus acotin has not been an issue.

Great.

Thank you for the caller.

Thank you.

One moment for our next question.

Our next question comes from Annabelle Femi with FIFO.

Your line is open.

Hi.

Thanks for taking my question.

So I realize I'm possibly putting the cart before the horse, but, you know, you studied GA in a range of disease severities.

So how do you envision approaching this market now?

It's clear from the data that the earlier the better.

But clearly the most desperate are the patients at risk of losing sight and maybe getting relief benefits.

So how are you initially going to be targeting this market as you as you as you enter the market?

I had a hard time hearing you.

Sorry, Annabelle, I had a hard time hearing you.

But Tim, who has better hearing than me, just clarified it for me.

I think, again, one of the very exciting parts of our data set is that every other month, with half the number of injections seems to give you close to probably 90 percent of the benefit in terms of slowing down the progression of geographic atrophy.

So that fits very nicely with the product profile.

But I think, you know, there's many product profiles, but two that stand out as being particularly attractive.

One is you have a patient who has lost all vision in one eye and wants to save as much vision as possible in the fellow eye.

Those are patients that probably you're going to want to treat as aggressively as possible, maybe with monthly dosing.

But then the other one, the one that you alluded to, is your newly diagnosed patient, maybe in your first eye.

You have an extra fovea, leaving the fovea as not affected.

It's still small, and you're going to want to make that investment in getting the most benefits over a long period of time.

And you're going to treat that patient with every two months dosing.

And we're going to see that's not a requirement for approval, of course, but it is something that is very exciting when you think about treatments not for two, but five or ten years, especially for those early lesions.

So we're going to find out what happens between month 18 and 24, but if that trend from the first three segments continues, that's something very exciting that I think we can then look forward to.

Extra foveal lesions early on, newly diagnosed, and making a long-term investment with every other month dosing, we believe is very important.

Okay.

And if I could, ask a follow-up.

So, you know, a lot of the TAOs we've talked to are looking for continued improvement over, time and maybe separation of slopes, you know, that you've shown in the segment data every six months.

Is this something that we have an idea of, is it just so they're looking at sustainability, or do they really want continued separation?

No.

Thank you, Annabelle.

I think, look, if you continue to save photoreceptor cells the way we believe you will, right, even if that is a linear saving, so if you stay, you know, around that 20% or even a little bit below that for a reduction in the growth of geographic atrophy based on the research that we did with the retinal community, that is sufficient.

Should we get, you know, an increased effect over time, that would, of course, be very, exciting and something that we can then explore in that point of time.

But it's not, we believe, a requirement for adoption of this drug.

Great.

Thank you.

One moment for our next question.

Our next question comes from Joseph Stringer with Needham.

Your line is open.

Hi.

This is Ben Ricard on for Joey Stringer.

Thanks for taking our question.

Just a quick one, you kind of mentioned a little bit about the Impovelli payer mix.

I think I heard around 25% Medicare, but just the overall payer mix, would you still characterize, that as relatively stable around 50-50, or do you expect that trend to continue or change?

Thanks.

Thank you.

I'm going to hand that over to Adam.

Yes.

So, yeah, the majority of Impovelli payer is obviously commercial.

And as we said before, 25% is a Medicare population.

I expect that to continue.

Great.

Thank you very much.

One moment for our next question.

Our next question comes from Douglas Au with H.P.

Wainwright.

Your line is open.

Hi.

Good afternoon.

Thanks for taking the questions, and congrats on the progress.

Just maybe as a follow-up, you made the comment about, you know, a lot of trying to start, patients early, especially with every other month dosing.

I'm just curious, how do you think about providing guidance to clinicians about when the time, to switch a patient from every other month dosing to monthly dosing?

Yeah.

Thank you so much, Doug, for that question.

So, I think, look, there is a dose response, right?

But that dose response is not like you get twice the benefit from doing the monthly injections, from what you get from every other month, right?

So, that's something that we will continue to evaluate over time.

And, again, every other month for us is something that is very important competitively as well, right?

I mean, again, to kind of reiterate, we have the first-mover advantage.

We have every other month dosing. We have data up to 18 months included in the file.

And then we have patients with foveal as well as extra foveal lesions that are included, in this profile.

So, it is something that we believe covers all populations that have this disease, whether, it's early, late, whether it's foveal, extra foveal, and where we believe over the long run you can make a big difference in terms of saving for recovery.

And just as a follow-up, I'm just curious, in the conversations with KOLs, do they appreciate, how much bang for your buck you get from every other month of dosing?

Yes, and it is something that we will continue to work hard on because we think that, I think, that up to this point, quite frankly, it has all been around, you know, what does the safety profile look like, does the drug work or not, and I think, you know, we've really shown over time that it does work and that it works well, that it may potentially work better the longer you treat, and that with every other month dosing you're close to probably in the range of 90% of the efficacy profile of monthly with half the number of injections.

That's not a part of the message that we focused on, but something that we will focus on a, lot in the months and years to come.

Okay, great.

Thank you very much.

Thank you.

And I'm not showing any further questions at this time, so I turn the call back over, to Cedric for any remarks.

Thank you so much.

I'm not sure, did you hear that, for any remarks, Cedric, or were you?

My closing remarks are not opening, so I'm closing.

I just want to thank all of you for joining.

We are really excited about the progress that we have made and what's ahead for us.

In September, we will report the 24-month data, and we will be around later today and, tomorrow should you have any additional questions.

Thank you again for joining us today, and have a wonderful rest of the week.

Q2 2022 Apellis Pharmaceuticals Inc Earnings Call

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