Q1 2022 Apellis Pharmaceuticals Inc Earnings Call

Hello, and welcome to Appellants Pharmaceuticals first quarter 2022 earnings conference call.

Hello, and welcome to Apellis Pharmaceuticals' first quarter 2022 earnings conference call.

At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session.

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

After the speaker presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone if you require any further assistance. Please press star zero. It is now my pleasure to introduce senior Vice President of Investor Relations and strategic Finance Meredith Kaya.

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

If you require any further assistance, please press star 0.

It is now my pleasure to introduce Senior Vice President of Investor Relations and Strategic, Finance, Meredith Kaya.

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

[music] good afternoon, and thank you for joining us to discuss propel us as first 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 Grossi, and Chief Financial, Officer, Tim Sullivan.

With me on the call our co founder and Chief Executive Officer, Dr. Cedric Francois Chief Commercial Officer, Adam Townsend, Chief Medical officers, Dr. Federico Crosby, and Chief Financial Officer, Jim Sullivan.

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

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

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.

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.

Thank you all for joining us today.

2022 is off to an extraordinary start at Apellis, as we continue to execute across, each of our key priorities.

2022 is off to an extraordinary start at applebee's as we continued to execute across each of our key priorities.

Starting with Intravitreal Taxidermy Plan for Geographic Atrophy, or GA, we've made, important progress as we prepare for the NDA submission later this quarter. We completed the pre-NDA meeting in January, and then in March, we shared 18-month data, from our Phase III, DERBY, and OCHS studies, demonstrating that longer-term treatment with Bexita Coplan resulted in an increasing benefit to patients, with greater amounts of retinal, tissue saved over time, and a favorable safety profile.

Starting with <unk> that group, then for geographic atrophy or G E.

We've made important progress as we prepare for the NDA submission later this quarter.

We completed the pre NDA meeting in January .

And then in March we shared the 18 month data from our phase III Derby and Oaks studies, demonstrating that longer term treatment with Betsy that coupon resulted in an increasing benefit to patients with greater amounts of retinal tissue states overtime and a favorable safety profile.

Additionally, these data showed improving effects in DERBY that were comparable with, OCHS starting at month 6.

Additionally, these data showed improving effect in derby that were comparable with <unk> starting at month six.

Just this week at ARVO, we shared additional 18-month data analyses that showed that Bexita, Coplan reduced lesion growth in patients with extra foveal lesions and in patients with foveal lesions, further supporting Bexita Coplan's benefits for a diverse population of patients across the GA disease spectrum.

Just this week at ARVO, we shared additional 18 month data analyses that showed that actually that groups on reduced lesion growth in patients with extra fulvio lesions and in patients with 12 year lesions.

They're supporting picture that coupons benefits for a diverse population of patients across the disease spectrum.

Collectively, these data reinforce the potential for Bexita Coplan to 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 towards legacy Tyco plan to become the first ever treatment for the millions of patients living with GE.

Relentless disease that is a leading cause of blindness worldwide.

Turning to <unk>.

Turning to Empavedi and PNH, the launch is off to a strong start in 2022, with approximately, $12 million in U.S. net sales, despite the initial headwinds due to the Omicron variant.

The launch is off to a strong start in 2022 with approximately $12 million in U S net sales.

The initial headwinds due to the Omi Crum variants.

We remain focused on further establishing Empavedi as a first-line treatment for patients, living with PNH. Our aim is to ensure that all patients with PNH, regardless of their baseline hemoglobin, levels, have the potential to benefit from Empavedi.

We remain focused on further establishing <unk> first line treatment for patients living with Pn H.

Our aim is to ensure that all patients with be a niche regardless of their baseline hemoglobin levels has the potential to benefit from above it.

The leading indicators for the launch remain strong, with positive physician and patient, feedback, a favorable patient mix, high levels of compliance, and positive recognition by payers.

The leading indicators for the launch remains strong with positive physician and patient feedback.

A favorable patient mix high levels of compliance and positive recognition by payers.

Globally, we are thrilled to see our partner Sobe begin to bring Empavedi, known also as, Aspavedi in certain countries outside the U.S., to patients worldwide.

Globally, we are thrilled to see our partners. So we begin to bring in poverty known also as <unk> in certain countries outside the U S to patients worldwide.

Beyond PNH, we are seeking to advance Empavedi as a transformative therapy for rare, complement-driven, diseases.

Beyond <unk>, we are seeking to advance and bug Eddie as a transformative therapies for rare complements driven diseases.

In the first quarter, we completed enrollment in our potentially registrational Phase II, therapy in amyotrophic lateral sclerosis, or ALS, with top-line results expected in mid-2023.

In the first quarter, we completed enrollment and are potentially registrational phase II study.

Amyotrophic lateral sclerosis, or ALS with topline results expected in mid 2023.

Additionally, Sobe dosed its first patient in a Phase II study in hematopoietic stem, cell transplant-associated thrombotic microangiopathy, or HSTTMA.

Additionally, she'll be dosed its first patient in a phase II study in hematopoietic stem cell transplant associated thrombotic microangiopathy or <unk> TMA.

Together with <unk>, we now have two late stage clinical programs underway and remain on track to initiate two additional programs in the second quarter.

Together with Sobe, we now have two late-stage clinical programs underway and remain on track, to initiate two additional programs in the second quarter. Combined, these opportunities could address the needs of as many as 35,000 patients per, year in the U.S. alone, significantly expanding the opportunity for Empavedi.

Combined these opportunities could address the needs of as many as 35000 patients per year in the U S alone significantly expanding the opportunity for <unk>.

We are also advancing complement inhibition as a novel approach to enabling adeno-associated, viruses, or AAVs.

We are also advancing complement inhibition as a novel approach to enabling <unk> associated viruses or agents.

In collaboration with SPARC Therapeutics, we look forward to sharing in vitro data with, APL-9 at the upcoming annual meeting of the American Society of Gene and Cell Therapy later this month. While early, with additional clinical investigation warranted, these in vitro data further support, our hypothesis that complement, and specifically C3, plays an important role in anti-AAV responses and that targeting C3 has the potential to help mitigate the safety and tolerability concerns associated with AAV delivery.

In collaboration with Spark Therapeutics, we look forward to sharing in vitro data with APL nine at the upcoming annual meeting of the American Society of gene and cell therapy nature of this month.

While early with additional clinical investigation warranted. These in vitro data further supports our hypothesis that complements and specifically C. III.

He has an important role in anti AEP responses, and then targeting <unk> three has the potential to help mitigate the safety and tolerability concerns associated with AAV delivery.

Finally, we are continuing to progress our early-stage pipeline with three INDs expected, over the next 18 months, including APL-2006, APL-1030, and our siRNA program, and continue to make great progress in our partnership with Beam Therapeutics.

Finally, we are continuing to progress our early stage pipeline with three A&D is expected over the next 18 months.

Including APL 20068.

APL 10, 30, and our SA RNA program and continues to make great progress in our partnership with beam therapeutics.

On the finance side, we ended the first quarter with close to a billion dollars in cash, providing, runway into the first quarter of 2024. This strong financial position allows us to head into our NDA submission and potential, launch from a position of strength in otherwise challenging market conditions.

On the finance side, we ended the first quarter with close to $1 billion in cash providing runway into the first quarter of 2024.

This strong financial position allows us to head into our NDA submission and potential launch from a position of strength and otherwise challenging market conditions.

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

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

Let me now turn the call over to Adam for a commercial update.

Let me now turn the call over to Adam for a commercial update Adam.

Adam?

Thank you, Cedric.

Thank you Patrick.

As Cedric mentioned, since our launch last May, we continue to see strong commercial, launch results for Empavelli and PNH, resulting in $12.1 million in U.S. net sales for the first quarter.

Rick mentioned since our launch last May we continue to see strong commercial launch results ramp of valley and P&I, each resulting in $12 1 million in U S. Net sales for the first quarter.

Before I get into the details of the launch, I'd like to take a moment to welcome Dr. Peter Hillman to the Appellus team. Pete will be joining us from the University of Leeds as head of hematology engagement, effective later this month. Pete is an internationally recognized hematologist, clinical researcher, and thought leader in, the PNH field who has been involved in the development of several PNH treatments, including, Empavelli. We are thrilled to have Pete coming on board and incredibly grateful for his continued, contributions to the PNH community.

Before I get into the details of the launch I'd like to take a moment to welcome Dr. Peter Hellman to the palace team Pete.

Pete will be joining us from the University of Leeds as head of Hematology engagement effective later this month.

Pete is an internationally recognized hematologists clinical research and thought leader in the <unk> field, who has been involved in the development of several <unk> treatments, including <unk>. We are thrilled to have peak coming onboard and incredibly grateful for his continued contributions.

The <unk> community.

Turning to the launch since approval in May 2021 through the end of the first quarter. We saw continued positive momentum across our key leading indicators.

According to the launch, since approval in May 2021, through the end of the first quarter, we saw continued positive momentum across our key leading indicators.

More than 150 start forms have been submitted, with 30 received in the first quarter. We continue to see the vast majority of Empavelli patient starts coming from C5 inhibitor patient, switches. With over 75% of these switches coming from Altamiris.

More than 150 start forms have been submitted with 30 received in the first quarter.

We continue to see the vast majority of <unk> patients start coming from C. Five inhibitor patient switches.

With over 75% of these switches coming from Altamira.

Another positive sign of demand is the continued growth of our Rems program with approximately 170 physicians certified at the end of the first quarter.

Another positive sign of demand is the continued growth of our REMS program, with approximately, 170 physicians certified at the end of the first quarter. Additionally, 19 of the top 20 payers have added Empavelli to formulary.

Additionally, 19 of the top 20 payers have added and P valley to formulary.

As we stated before, we initially focused on the top 20 payers, covering approximately, 85% of all US PNH prescriptions, and are thrilled with the progress we've made within the first year. One of the largest US payers has also placed Empavelli as exclusive for all treatment naive, patients.

As we stated before we initially focused on the top 20 payers covering approximately 85% of all U S. <unk> prescriptions and are thrilled with the progress we've made within the first year.

One of the largest U S. Paas has also placed and per valley as exclusive for all treatment naive patients.

And lastly, we are continuing to see high patient compliance rates in 2022, which we, believe is a testament to the benefits of Empavelli, and how much better patients feel when their disease is well controlled.

And lastly, we are continuing to see high patient compliance rates in 2022, which we believe is a testament to the benefits of <unk> and how much better patient feel when that disease is well controlled.

As the quarter progressed in Paas and access to physicians increased and we saw a return of impasse in conferences and events.

As the quarter progressed, in-person access to physicians increased, and we saw a return, of in-person conferences and events. This has allowed us to better connect with key HCPs who had been more difficult to engage, with during the Omicron wave earlier this year.

This has allowed us to better connect with key HCP, who.

Had been more difficult to engage with during the omicron wave earlier this year.

We look forward to further executing on our launch efforts in the US, and will continue, to educate physicians, secure additional payer coverage, and bring Empavelli to patients in the need of treatment.

We look forward to further executing on our launch efforts in the U S and we will continue to educate physicians <unk>.

Few additional payer coverage and bring <unk> to patients in the need of treatment.

Additionally, we've submitted our supplemental NDA, which includes the phase 3 PRINCE results, in addition to the 48-week phase 3 PEGASUS data.

Additionally, we submitted a supplemental NDA, which includes the phase III <unk> results. In addition to the 48 week phase III Pegasus data.

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

Proved by the FDA this will allow us to strengthen our promotion of <unk> for treatment naive patients and raise more awareness of our long term efficacy and safety data.

Turning to our commercial efforts in GA, 2022 will be a pivotal year for all of us here, at Appellus, and for the millions of patients suffering from GA globally.

Turning to our commercial efforts in <unk> 2022 will be a pivotal year for all of US here at palace and for the millions of patients suffering from Gi globally.

GA causes irreversible damage, and is the leading cause of vision loss, impacting more, than 5 million people worldwide, including 1 million people in the United States. We are compelled by the unmet need, loss of independence, and emotional burden of patients, living with GA. We recently shared results from a Geographic Atrophy Insights Survey, referred to as GAINS, conducted by the Harris Poll on behalf of Apellis. GAINS surveyed over 200 adults with GA across nine countries.

GAA causes irreversible damage and is the leading cause of vision loss impacting more than 5 million people worldwide, including 1 million people in the United States. We are compelled by the unmet need lots of independents and emotional burden of patients living with GE.

We recently shared results from a geographic atrophy insight survey referred to as game.

Conducted by the Harris poll on behalf of our palace.

Gay surveyed over 200 adults with GAA across nine countries.

Results revealed that nearly 7 in 10 people believe the impact on independence and quality of life, due to their visual decline is worse than they expected.

Results revealed that nearly seven in 10 people believe the impact on independence and quality of life.

To that ratio decline is worse than I expected.

More than two out of three people reported that they rely on a caregiver for support.

More than two added three people reported that they rely on our CAG gives us the support.

And the majority said that they feel the disease negatively affects aspects of everyday life, such as the ability to read, drive, and travel.

And the majority said that they feel that disease negatively affects aspects of everyday life, such as the ability to read drive and travel.

Approximately one in three said they have recently withdrawn from their social lives because of their disease, and reported feelings of anxiety, powerlessness, and frustration.

Approximately one in three said they have recently withdrawn from their social lives because of their disease and reported feelings of anxiety powerlessness and frustration.

It is overwhelmingly clear treatments are needed and needed now.

It is overwhelmingly clear treatments are needed and need it now.

More than ever, we believe that Pegstetter-Coughlin is positioned to meet this significant unmet need, and we are committed to working to bring this therapy to as many patients as possible as quickly as possible.

More than ever we believe that <unk> is positioned to meet the significant unmet need and we are committed to working to bring this therapy to as many patients as possible as quickly as possible.

Our commercial team is preparing for a potential launch as early as the end of the year. We have onboarded several of the key leadership positions in medical affairs, sales and marketing, and market access within the U.S., and additional leadership positions globally.

Our commercial team is preparing for a potential launch as early as the end of the year.

We have on boarded several of the key leadership positions in medical affairs sales and marketing and market access within the U S and additional leadership positions globally.

We are initially focused on those retina specialists who manage the majority of GA patients.

We are initially focused on those retina specialists to manage the majority of <unk> patients. We also continue to make strides in our near term launch initiatives focused on disease State education, K O L and payer engagement activities.

We also continue to make strides in our near-term launch initiatives focused on disease state education, KOL and payer engagement activities.

In the EU, we remain on track to submit our MAA in the second half of 2022.

In the EU, we remain on track to submit our MAA in the second half of 2022.

We look forward to providing more detail on our commercial plans as we prepare for launch.

We look forward to providing more detail on our commercial plans as we prepare for launch.

We will now turn the call over to Feday to review our clinical developments.

I will now turn the call over to Fred to review, our clinical development today.

Feday?

Thank you, Adam.

Thank you Adam.

Submitting the MDA later this quarter is one of our highest priorities. As Cedric mentioned, we are excited to share the 18-month data from Derby and OCHS, which showed continuous and clinically meaningful benefits to a diverse and broad group of patients over time.

Submitting the NDA later this quarter is one of our highest priorities.

As Cedric mentioned, we are excited to share the 18 month data from Derby and Oaks, we showed continuous and clinically meaningful benefits to a diverse and broad group of patients over time.

As highlighted on this slide, both monthly and every-other-month treatment with Pexeta-Coplan, continue to reduce GA lesion growth compared to PUL-SHAM at 18 months, with all nominal P-values below 0.05 in both Derby and OCHS.

As highlighted on this slide both monthly and every other month.

Men with VIX at the Copeland continued to reduce G&A lesion growth compared to pull sham at 18 months, we'd all nominal P values below 0.05 in boss Derby and Oaks.

This means that there was a larger absolute difference between Pexeta-Coplan and SHAM, in GA lesion area than observed at month 12.

This means that there was a larger absolute difference between fix at the Copeland and Sham NGA lesion area than officer at month 12.

In an effort to understand how the treatment benefits evolve over time, we then look at the effects with Pexeta-Coplan at 6-month intervals and found that the treatment effects in Derby were comparable to OCHS during months 6 through 18.

In an effort to understand how the treatment benefit evolve over time.

We then look at the effects with Brexit the Copeland at six months intervals and.

Found that the treatment effect in Derby, where comparable to ox during months six through 18.

Exeter-Copeland, in both studies, continued to demonstrate a favorable safety profile, as shown in the Philly study and the 12-month top-line Derby and Oakes data readout.

Except the Copeland in both studies continued to demonstrate a favorable safety profile as shown in the <unk> study and the 12 months topline that'll be <unk> data readout.

Additionally, and most importantly, the combined 18-month data showed the potential for improvement, treatment effects over time.

Additionally, and most importantly the.

Combined 18 month data showed the potential for improvement treatment effect over time.

Then earlier this week at the ARVO.

Again, earlier this week, at the ARBO Annual Meeting, we and our collaborators had 10 presentations, including three oral presentations, showcasing our leadership in the retina. In one of the oral presentations, we shared 18-month data, which showed that Pexeter-Copeland, continued to demonstrate a reduction in GA lesion growth in patients with extra-fold lesions and an improved effect in patients with foveal lesions. In the combined Derby and Oakes data, monthly and every other month treatment with Pexeter-Copeland, reduced extra-fold lesion growth by 26% and 21%, respectively, and reduced foveal lesion growth by 13% in both arms.

Annual meeting, we and our collaborators at 10% patients, including three oral presentations showcasing our leadership in the west.

And one of the oral presentations, we sure 18 month data, which showed that thinks that the Copeland continued to demonstrate a reduction in GAA lesion growth in patients with extra formulations.

And then improve effect in patients with formulations.

In the combined there'll be announced data.

Anthony and every other month treatment with Brexit, the Copeland reduce extra forgone lesion growth by 26% and 21% respectively.

And we use formulation growth by 13% in both arms.

The total OP values were all below 0.05.

Nominal P values were all below zero point zero flat.

This additional data reinforces the potential effects of the Copeland to slow the progression of <unk> outgrowth of disease spectrum.

This additional data reinforced the potential of Pexeter-Copeland to slow the progression, of GA across the disease spectrum, which is critically important given the heterogeneity of this patient population.

Which is critically important given that the journey of this patient population.

We are excited to potentially bring a therapy to all patients with GA, with an additional, opportunity to treat early in disease progression and save as many photoreceptor cells as possible throughout the course of the disease.

We're excited to potentially bring a therapy to all patients with <unk>.

With an additional opportunity to treat early in disease progression and save us many photoreceptor cells as possible throughout the course of the disease.

We're also excited to present the 18-month fellow eye compilation at an upcoming medical, meeting and expect the results to be generally consistent with what we saw at Topline.

We're also excited to present, the 18 month fellow completion.

And upcoming medical meeting and expect the results to be generally consistent with what we saw top line.

We're also working to deliver on the broad platform potential.

We're also working to deliver on the broad platform potential of Empabeli to advance, our disease franchise, which includes four late-stage studies in multiple complement-driven diseases.

To advance our rare disease franchise, which includes four late stage studies in multiple complement driven diseases.

In addition to what Cedric mentioned earlier regarding our LS and HSCT TMA studies, we, also expect to dose the first patient in a Phase III study in immune-complex membranoproliferative glomerulonephritis, or ICMPGN, and C3 glomerulopathy, or C3G, in the second quarter.

In addition to what Cedric mentioned earlier regarding a L. S. H S&P TMA studies, we also expect to dose the first patient in the phase III study in immune complex Mcdonough plugging surety glomerulonephritis, or IC and PGN <unk> <unk>, three blue myelopathy or C. G.

In the second quarter.

Our partner, Sobe, remains on track to initiate a Phase III study in collaglutinin disease, or CAD in the second quarter.

Our partner Saudi remains on track to initiate a phase III study in Cala gluten indices.

In the second quarter.

We're excited to share our continuous progress across these rare disease programs.

We're excited to share our continuous progress across the web and since programs.

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

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

Tim?

Dean.

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 first quarter of 2022. Total revenue was $14.4 million, which consisted of $12.1 million in Empabeli net product revenue, and $2.3 million in collaboration revenue from Sobe.

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

Total revenue was $14 4 million, which consisted of $12 1 million and <unk> net product revenue and $2 3 million in collaboration revenue from Tobey.

Our R&D expenses were $90.9 million, G&A expenses were $51.2 million, and we reported a net loss, of $138.9 million.

R&D expenses were $90 9 million G&A expenses were $51 2 million and we reported a net loss of $138 9 million.

As of March 31, 2022, Apellis had $965.3 million in cash, cash equivalents, and short-term, marketable securities, excluding the additional $50 million milestone received in April from, Sobe. Our cash balance reflects $380.1 million in net proceeds from our offering in March.

As of March 31, 2020 to tell us at $965 3 million in cash cash equivalents and short term marketable securities. Excluding the additional $50 million milestone received in April from Tobey.

Our cash balance reflects $380 1 million in net proceeds from our offering in March 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 ceded Coplin NGA and further development of our pipeline.

We expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing Ampevelli launch, the global launch of Pegasida Copland and GA, and further development of our pipeline.

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

We remain confident in <unk> financial future as we continue to execute on our upcoming milestones I will now turn the call back over to Cedric for closing remarks Cedric.

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

Cedric?

Thank you, Tim.

Thank you Tim we have made excellent progress over the past few months and look forward to an exciting rest of the year.

We have made excellent progress over the past few months and look forward to an exciting, rest of the year.

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

By yearend, we expect to have further cements our position as a global leader in complement with two commercial products and a robust pipeline encompassing multiple late stage rare disease programs and additional preclinical programs heading into the clinic.

We look forward to building on the company's momentum throughout the coming year and to, updating you on our progress.

We look forward to building on the company's momentum throughout the coming year and to updating you on our progress.

And let us now open the call for questions.

And that is now open the call for questions operator.

Operator?

Thank you.

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Our first question comes from the line of Madhu Kumar with Goldman Sachs.

And our first question comes from the line of Madhu Kumar with Goldman Sachs.

Hey, guys.

Thanks for taking our questions.

Oh, Hey, guys. Thanks for taking our questions. So I guess the first one relates to the European filing strategy for <unk>. Thanks for the call Glenn how should we think about that and then you can see the 24 month data both in terms of GAA lesion growth and in terms of functional assessments of vision before you kind of.

I guess our first one relates to the European filing strategy for a PEG clinical plan.

How should we think about that, and do we need to see the 24-month data both in terms, of GA lesion growth and in terms of functional assessment divisions before you kind of formally start the process of filing for approval in Europe?

Formally start the process of filing for approval in Europe .

Thank you so much metal great to hear you. So we are meeting with the Rep Archer's in Europe , and those interactions are going very well.

Thank you so much, Madhu.

Great to hear you.

So we are meeting with the rapporteurs in Europe, and those interactions are going very, well.

Our plan continues to be to file in the second half of this year.

<unk> continues to be to file in the second half of this year and as you mentioned the 24 month data is something that you know.

And as you mentioned, the 24-month data is something that, you know, will be updated, in that package.

It will be updated in the package.

The functional endpoints, I want to again point out, you know, that the expectation, there should not be to see something statistical.

The functional end points I want to again point out that the expectation there should not be to see something statistical it never was.

It never was.

The European regulators want to understand what the functional relationship is with the, photoreceptor cell depth that we measure with the anatomical endpoints.

And the European regulators want to understand whats dysfunctional relationship is with the full receptor cell death that we measure.

With the anatomical endpoints. So all of that will be included and against the second half of this year continues to be our guidance.

So all of that will be included, and again, the second half of this year continues to, be our guidance.

Okay.

And then one more question for you on GA market size.

Okay.

A question for you on GM market size so.

So a question we kind of have been getting more recently is what fraction of GA patients, are functionally or legally blind in one eye, and how does that affect kind of the treatment decision versus patients who have functional vision in both eyes?

A question on the claims have been getting more recently is what fraction of <unk> patients are functionally are legally blind in one eye and how does that affect kind of the shipping decision versus patients who have functional vision in both eyes, but can you. Just are you looking at that question and what are you hearing out there.

Like, if you look at that question, and what are you hearing?

Thank you, Maddy, for that question.

Yeah. Thank you Matt for the question. So the number there is around 40% of patients. So it's a very high number of <unk>.

So the number there is around 40% of patients, so it's a very high number of patients who, are legally blind in one eye and affected by GA in the fellow eye. That is particularly a target population that is of interest for many retinadocs because, of course, those are the patients that are most at risk of catastrophic bilateral vision loss.

Patients who are.

Legally blind in one eye and affected by G.

The fellow eye that is particularly.

A target population that is of interest for many retina docs because of course those are the patients that are most at risk of catastrophic bilateral efficient most.

Okay, great.

Okay, great. Thanks, very much guys.

Thanks very much, guys.

Thank you, Nadu.

Thank you Matthew.

Thank you.

Thank you and our next question comes from the line of Jon Miller with Evercore.

And our next question comes from the line of John Miller with Evercore.

Yeah.

Hi, guys.

Hi, guys. Thanks, so much for taking the question I guess, one on let's start with cash runway I guess into 'twenty four seems to get you're willing to the launch, but what's the likelihood that that can get you to profitability.

Thanks so much for taking the question.

I guess one on, let's start with cash runway.

I guess INTO24 seems to get you well into the launch, but what's the likelihood that, that can get you to profitability?

And given the new runway, how have BD priorities and discussions shifted since the recent raise?

And given the new runway.

BD priorities in discussions shifted since the recent raise.

Thanks.

Thanks.

I'm going to hand that one over to Tim.

And over to Tim.

Sure.

Sure. Thanks, John So with this recent capital raise as you said our runway does get us into the first quarter of 2024.

Thanks, John.

So with this recent capital raise, as you said, our runway does get us into the first, quarter of 2024.

And in terms of that.

And in terms of that, there are a lot of assumptions out there that could fluctuate that kind of, profitability one way or the other.

There are a lot of assumptions out there that could fluctuate.

The targeted profitability, one way or the other so we're not guiding to profitability based on that.

So we're not guiding to profitability based on that timeframe.

Time frame.

However, I don't think that capital really gets us a comfortable cash balance if we get, to profitability.

However.

I don't think that capital really gives us a comfortable cash balance if we get to profitability. So we're going to continue to be thoughtful about what.

So we're going to continue to be thoughtful about what that potential financing that would, get us there looks like.

What the potential financing that would get us there looks like.

We're looking at approaches that may include debt, royalty, partnerships, or other financing, vehicles.

We're looking at approaches it may include.

Royalty partnerships or other financing vehicle.

But the good news is that we have a very strong cash balance right now, and we can take our, time to figure out what makes sense for the company.

But.

Good news is that we.

We have a very strong cash balance right now and we can take our time to figure out what makes sense for the company.

Great.

Great that makes sense and then maybe one more follow on on the 24 month data that was just discussing.

That makes sense.

And then maybe one more follow-on on the 24-month data that we just were discussing.

When we think about FDA, if they get that 24-month data later this year, what's so likely, that constitutes a major amendment and pushes out the PDUFA?

We think about F D a.

You'd get that 24 month data later this year, what's the likelihood that constitute a major amendment and pushes out the paducah.

Yeah.

Yeah. Thank you John so likelihood of that is very very small.

Thank you, John.

The likelihood of that is very, very small and would be based on surprises, right?

And would be based on surprises right. So.

So we have, of course, amply discussed this in anticipation.

We have of course amply discussed this in anticipation and the reason why the 24 month data is not something we need to wait for us because we don't expect to learn anything new between months 18 24. So.

And the reason why the 24-month data is not something we need to wait for is because we, don't expect to learn anything new between month 18 and 24.

So, of course, when we have the data, we will communicate it, but it's not scheduled to, be a major amendment.

Of course, when we have the data we will communicate it but it's not scheduled to be a major amendments.

Great.

Great. Thanks very much.

Thanks very much.

Thank you.

Q.

Thank you and our next question comes from the line of Philip Nadeau with Cowen <unk> Company.

And our next question comes from the line of Philip Nadeau with Cowan & Company.

Yes.

Good afternoon.

Good afternoon, and thanks for taking my questions a couple more regulatory in terms of an FDA panel what are your expectations.

Thanks for taking our questions.

A couple more on regulatory.

In terms of an FDA panel, what are your expectations?

Do you think the FDA would want to hold one, and if so, what would they hope to learn?

Do you think the FDA would want to hold on and if so what would you hope to learn and then second on the timing we notice on slide 13, you suggested that kind of approval is possible this year.

And then second, on the timing, we noticed on slide 13 you suggested an approval is, possible this year.

Our understanding of the regs at the FDA is they have two months to accept any filing, and then even with prior review, it's six months after the acceptance for the PDUFA.

Many of the rigs with two months to accept any filing and then even with prior review it's six months after the acceptance.

So it seems like even if you were to file today, The 2023 PDUFA day would be likely, we're curious what you heard from the FDA that gives you some confidence that an approval could actually come before the end of this year.

For the producers.

Like even if you were to file today.

Thanks.

2023 producer day would be likely I'm curious what you heard from the FDA that gives you some confidence that the approval could actually come.

Before the end of this year. Thanks.

Yeah, thank you so much, Phil.

Thank you so much feels so two great questions I'm going to start with the second one.

So two great questions.

I'm going to start with the second one.

So the six months from the time of acceptance is a timeline that depends on a new chemical, entity.

So the six months from the time of acceptance is a timeline that depends on the new chemical entity because picks at that coupon is already approved in the different products of course, it is no longer a new chemical entity and that between six months from the time of filing rather than acceptance.

But because Pexita Coplan is already approved in a different product, of course, it is, no longer a new chemical entity.

And that would mean six months from the time of filing rather than acceptance.

So as it relates to the, and that would, of course, you know, put us at the end of this, year still, even if it were to be at the end of the second quarter.

As it relates to the end up with of course, you know.

What was it at the end of this year still even if it where it should be at the end of the second quarter.

Now as it relates to the FDA panel, we are operating under the assumption that there, will be one.

Now as it relates the FDA panel, we are operating under the assumption that there will be one we will be ready to have one it is of course.

We will be ready to have one.

It is, of course, you know, potentially the very first approval in this very important, new indication.

Potentially the very first approval in this very important new indication.

You know, I think when we think about what could be discussed during a panel like that, I want to remind people that the way in which the NDA is being submitted, kind of the center drums with four cornerstones, right?

You know I think.

When we when we think about what could be discuss during our patent leg.

To remind people that the way in which the NDA is being submitted.

Centered ramps.

With four cornerstones right. The first one is safety the <unk>.

The first one is safety.

The second one is the biological activity of the drug.

One is the biological activity of the drug does it work and that is premised on meeting the primary endpoint in two studies <unk> <unk> and then on the fellow eye analysis in patients with bilateral GA.

Does it work?

And that is premised on meeting the primary endpoint in two studies, Philly and Oakes.

And then on the fellow eye analysis in patients with bilateral GA.

The third chapter or the third cornerstone is then, you know, what is the real effect, size?

Third chapter the third cornerstone is then what is the real effect because between the three studies that we have we have an effect size ranging from 12% to 29% and was a cool varies analysis clearly at one year cleanly sits at around 20%.

Because between the three studies that we have, we have an effect size ranging from, 12% to 29%. And with the covariate analysis, clearly at one year, clearly sits around 20%.

Then the fourth cornerstone is what happens going into year two.

Then.

The fourth cornerstone is what happens going into year, two and of course that was one of the foundational principles of including the 18 month data as well where do we want to understand what is the long term impact of treatment with this drug and the disease that people will have four years, if not decades.

And of course, that was one of the foundational principles of including the 18-month data, as well, where we want to understand what is the long-term impact of treatment with this drug in the disease that people will have for years, if not decades.

So in the context of an outcome, should there be one, kind of the only subject that is really, you know, kind of an interesting one is what does 20% at one year mean?

So in the context of an outcome should there be one kind of the only subject that is really kind of an interesting. One is whats what does 20% at one year mean, what does kind of the continued benefits over time mean for patients in terms of safety, where we set for ourselves.

What does kind of the continued benefits over time mean for patients in terms of safety, for receptor cells?

But we do not believe that, other than that there are many controversial elements in this, submission.

But we do not believe that other than that there are many controversial.

Elements and the submission.

Okay.

So it sounds like you think a panel would go into that major subject of kind of what's, the clinical significance of the data or of the results that you've shown.

Got.

It sounds like you think a panel would go into that major subject.

What's the clinical significance of the Dana.

<unk>.

The results that you're showing is that am I interpreting.

Is that...

Am I interpreting what you're saying correctly?

What youre, saying correctly.

Yeah.

Yeah. The question was if you haven't been on what would be discussed and nothing that would be kind of the probably the VIX.

I mean, the question was, if you have a panel, what would be discussed?

And I think that would be kind of the, probably the sixth.

Now we have done a ton of research on that, of course, in the preparation for the launch.

Now we have done a ton of research on that of course and the preparation for the launch.

And the general consensus among physicians is that 20% is clinically meaningful.

And the general consensus amongst physicians is that 20% is clinically meaningful. So it's also not really subject that we believe that will be problematic for us.

So it's also not a subject that we believe will be problematic for us.

Got it.

Thanks for taking the question.

Got it thanks for taking my question Thats very helpful.

That's very helpful.

You're welcome.

Thank you.

Youre welcome.

Thank you.

And our next question comes from Steve Seedhouse with Raymond James.

And our next question comes from Steve seed House with Raymond James.

Yes.

Hi.

This is Timur Ivanikov on for Steve Seedhouse.

Yes, Hi, this is more of an it goes on for Steve seat House.

So just a question on GA.

So just a question on G&A I think you've talked about the importance of educating retina retina docs and assuming the drug is approved.

I think you've talked about the importance of educating retina docs.

And assuming the drug is approved, what do you think will be the best way to communicate, the benefit of Texa-TACO plan if a patient doesn't really see a change in symptoms over a year, or maybe the symptoms are worse, but it's not really clear whether the drug is helping?

Do you think will be the best way to communicate the benefit of tax attack plan, if a patient doesn't really see a change in symptoms over a year or maybe the symptoms are worse, but it's not really clear whether the drug is helping.

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

Yeah. So thank you so much for that question tumor.

I think it's a very important one right I mean, I would say that what's most resonates with retina doctors is when you talk to them about the area of saved retina right I mean, that's a very tangible.

I think it's a very important one, right?

I mean, I would say that what most resonates with retina doctors is when you talk to them about the area of saved retina, right? I mean, that's a very tangible thing to look at, right?

I mean, it's not a percentage slowdown or whatever.

The thing to look at it right I mean, it's not a percentage slowdown or whatever how much retina.

It's how much retina is actually being preserved. And we disclosed the number with the 18-month data of Oakes, for example, where at one year, 0.41 square millimeter of retina was preserved compared to the sham, whereas at 18 months, that was already 0.66 square millimeters.

Being preserved and we disclosed the number with.

With the 18 month data of Uber for example, we're at one year of <unk> 41 square millimeter of retina preserves compares to the sham, whereas at 18 months that was already 66 square millimeters and you could say well what is the square millimeter into retina, well think about it this way.

And you could say, well, what is a square millimeter in the retina? Well, think about it this way, you know, approximately or even less than two square millimeters is responsible for all of our central vision.

Approximately or even less than two square millimeters is responsible for all of our central vision, So what we need to reach charging which determines.

So what we need to read charts in which, you know, determines visual acuity.

So there's a lot of retina over the course of, you could say, a year and a half, a lot, but in the picture of a treatment with GA, a very short period of time.

Determines visual acuity so.

And Theres a lots of retina over the course of you could say you are in the health of lots, but in the picture of the treatment with <unk>, a very short period of time.

Okay, got it.

Okay got it. Thank you and then maybe just a quick follow up in terms of fast progressive that you've talked about in Derby on the other hand do you have.

Thank you.

People, who are the best responders, who are deep responders do you have patients who did not really progress at all on <unk>.

And then maybe just a quick follow-up.

And if you do what does the distribution of those patients across the studies.

Yeah. So those those are those are deep details that overtime, we will we will talk about more.

Yeah. It is it is.

Very rare for patients do not progress at all that kind of care of course, but it's rare.

And if it goes in distribution rights goes from very fast to no progression at all.

How exactly that burns out.

Will in due time published but what's important is that you have many variables that can drive how fast these patients progress and so it's easy for a study to be out of balance because you can't quite frankly, not stratified study properly engineered.

Be well balanced so sometimes you can't get Lucky and security for example, we probably we were lucky in terms of the distribution of the patients between chairman Xs resident Derby and what we got we were unfortunate right.

In the sense that.

As you mentioned these very rapidly progressive patients for disproportionately allocated to the acquisition of Monkey arm.

Okay. Thank you very much.

Youre welcome.

Thank you.

Question comes from the line of Chris Howerton with Jefferies.

Hi team. This is <unk> on for Chris. Thank you for taking our questions.

Couple of questions for Us what are your takeaways from the Derby extra fogel.

Subgroup analysis were you surprised to see every other month performing better than monthly and that group in.

General broader takeaways NGA.

From that finding.

And then as a second question.

Thinking about kind of function.

How <unk> will impact patients' visual function.

A high fidelity functional measure NGA and kind of like what's the most practical.

To measure function with something like a digital amsler grids beam tactical and easy to implement.

To measure visual function.

Thank you so much cone beam so.

Let me start with the extra Formula question, So here too.

By the way the 12 month data on extra full view, we also disclosed I believe it was at the retina Society and at the beginning of October right and so to continue we do have an inverse dose relationship there, but one that will be interesting to see how it continues to progress over time right and there you see the true manifestation of what I am.

And earlier, which is that in Derby and the monthly arm not in every other month, but in lumpy. We had this rapidly progressing patients right.

In terms of fast progressors, that you've talked about in DERBY, on the other hand, do you have people who are best responders, who are deep responders?

Do you have patients who, you know, did not really progress at all on GA?

They have they.

They run at a disadvantage compared to the sham and there even at a disadvantage compared to every other months, but what's very interesting and good to see is how over time that compensates, which.

And if you do, what is the distribution of those patients across the studies?

Yeah, so those, you know, those are deep details that over time we will talk about, more.

It is very rare for patients to not progress at all.

That can occur, of course, but it's rare.

And it goes in distribution, right?

It goes from very fast to no progression at all.

How exactly that pans out, you know, we will, in due time, publish.

Which we also clearly disclosed in the 18 months update that we gave in March.

And then as it relates to functions. So one of the big problems that we have in geographic atrophy, but in the retina in general is that measuring function, it's very difficult and incomplete and the retina right. So you can see visual acuity for example, which is the best known well that only measures your central vision to read the chart.

What you need is the central portion of your vision and you could read the chart looking through a straw if you wanted to but as I told you to run across the street looking through a strong of course that gives you an idea.

How far of the measure for function that medias rent we do.

I have some visual questionnaires that can be helpful again to understanding how function evolves, but theyre also incomplete.

Reading speeds is another one but that one two varies widely.

Then the same patients right I mean, you're reading speed in the morning is different from the evening for example.

Micro Perimetry. This is a really interesting one it's an intense examination takes several hours, where we signed a laser with different frequencies in the back with.

With several spots, but again there are a number of spots you can test are limited. So all of these things have their limitations.

And they can provide the contextual context, but what is important and this is the reason why the FDA and every regulatory organization that we deal with has accepted the anatomical endpoints of auto fluorescence.

But what's important is that you have many variables that can drive how fast these patients progress.

And so it's easy for a study to be out of balance because you can, quite frankly, not, stratify a study properly in GA to really be well-balanced.

So sometimes you can get lucky in study, for example.

You know, we probably were lucky in terms of the distribution of the patients between CHEM and Actis, whereas in DERBY, you know, we got, we were unfortunate, right? In the sense that, as you mentioned, these very rapidly progressive patients were disproportionately allocated to the Actis monthly arm.

Overtime is that its measures directly how quickly retinal cells die right. So yes, it's not all anatomical endpoints, but with almost with close to single cell resolution rate, we can measure.

How quickly patients are actually losing photoreceptor cells, which is directly correlated positions.

Okay, thank you very much.

Thank you so much.

You're welcome.

Youre welcome.

Thank you.

Thank you and our next question comes from the line of Colleen <unk> with Baird.

And our next question comes from the line of Chris Howerton with Jeffries.

Hi, team.

This is Kambizan for Chris.

Hi, good afternoon, thanks for taking our questions.

Thank you for taking our questions.

So can.

Can you I think in the 18 months update we did see some of the slope analysis I.

I guess do you have a sense of.

Yes.

On the slope analysis, and what they care about the entirety. So I'm here to 12, or even 18 or could that be more heavily weighted towards the later slope St months 12 to 18.

Thank you so much and that is a really great question. So.

A couple questions, for us.

What were your takeaways from the DERBY extrafobial subgroup analysis?

Were you surprised to see every other month performing better than monthly in that group?

Again kind of going back to the way in which our primary endpoint is measured right. We look at lesion size reduction overtime.

And I guess just any general broader takeaways in GA from that finding.

And then as a second question, thinking about kind of function and how a fixated coplan will impact patients' visual function, what's the most high-fidelity functional measure in GA?

And kind of like what's the most practical way to measure function?

That is what we agreed on with the FDA and Thats. The way we do the primary endpoint analysis. However in secondary analysis. Among many other things we do is look analysis.

Would something like a digital AMSLR grid be practical and easy to implement to measure visual function?

Thank you.

Thank you so much, Kambiz.

So let me start with the extra-foveal question.

Broke analysis gives you exactly the same outcome as you get four.

For the measurement of overtime, but as close to the exactly the same.

You make it very important in my opinion really critical importance, which is also a slow can be measured in various ways. You can go from for example over one year from zero to 12 months you can go from zero to six months six to 12.

Or you could even go from 12 to 18 the way we did it.

18 months' time point that is important because the slope gives you an idea of what to expect over time and how consistent the measurements are amongst each other so it is a contextual tool to understand what the long term impact of treatment on patients and what we showed with the 18 month data in March is that if you take.

So here too, you know, by the way, the 12-month data on extra-foveal, we also disclosed, I, believe it was at Retina Society in the beginning of October, right?

And so to continue, we do have an inverse dose relationship there, but one that will, be interesting to see how it continues to progress over time, right?

And there you see the true manifestation of what I mentioned earlier, which is that, in DERBY, in the monthly arm, not in every other month, but in monthly, we had this rapidly progressing patients, right? So they have, they're at a disadvantage compared to the sham, and they're even at a disadvantage, compared to every other month.

It's in the <unk> piece wise linear slope analysis from zero to six 6% to 12 and 12 to 18 that these insects seem to be compounded right and as I have geographic atrophy today, it's not that important how bad my disease was two years ago or 18 months ago I care about what it is like now because that is what I will do.

In all likelihood carryforwards as long as that.

But what's very interesting and beautiful to see is how over time that compensates, you know, which we also clearly disclosed in the 18-month update that we gave in March.

And in that sense, a 12 to 18 month data looks very good with a data much more consistent between Derby and Oaks that for example at the beginning of the study.

Then as it relates to functions, so one of the big problems that we have in geographic, atrophy, but in the retina in general, is that measuring function is very difficult and incomplete in the retina, right?

So you can say visual acuity, for example, which is the best known, well, that only measures, your central vision.

To read a chart, what you need is the central portion of your vision, and you could read, a chart looking through a straw if you wanted to.

But if I told you to run across the street looking through a straw, of course, that gives, you an idea how poor of a measure for function that really is, right?

We then have some visual questionnaires that can be helpful, again, to understanding how, function evolves, but they're also incomplete.

Reading speed is another one, but that one, too, varies widely within the same patient, right? I mean, your reading speed in the morning is different from the evening, for example.

Great. Thank you, that's really interesting and potential G. A launch I guess, how much focus will be on retina specialists that are already seeing probably more advanced <unk> patients and how much focus will be on educating optometrists are general ophthalmologists.

And then microperimetry is a really interesting one.

So all of these things have their limitations, and they kind of provide a contextual context.

It's an intense examination, takes several hours, where we shine the laser with different, frequencies in the back with several spots, but again, there, the number of spots you can test are limited.

But what is important, and this is the reason why the FDA and every regulatory organization, that we deal with has accepted the anatomical endpoint of autofluorescence over time, is that it measures directly how quickly retinal cells die, right?

So yes, it's an anatomical endpoint, but with almost, with close to single cell resolution, right, we can measure how quickly patients are actually losing photoreceptor cells, which is directly correlated to vision.

<unk> earlier stage patients.

Thank you so much.

Yeah. Thank you so much coding I'm going to hand that one over to Adam.

You're welcome.

Thanks, Kelly and thanks for the question.

Thank you.

And our next question comes from the line of Colleen Cussey with Baird.

<unk>.

A quick Little reminder, right. So we'll target around 3000, retina specialists and some optometrists as well right to drive patients who are unaware that the treatment to a retina specialists.

Hi.

Good afternoon.

Thanks for taking our questions.

Our focus is on the target list of about 3000.

But an interesting piece of information right about 900 retinal specialists do about 85% of all of the <unk> injections for asbestos. So it's a really really concise group of physicians that do the bolus of injecting so it's a very easy target for us too.

Go and introduce ourselves to and start to build commercial relationships with as we said on the call. We started to onboard several of our leadership positions across commercial medical affairs marketing and interestingly enough we.

So can you talk, I think in the 18-month update, we did see some of the slope analysis.

I guess, do you have a sense of the FDA's view on the slope analysis, and would they, care about the entirety, so, you know, like 0 to 12 or 0 to 18, or could that be more heavily weighted towards the later slope, so say months 12 to 18?

Thank you so much, Colleen.

That is a really great question.

So again, kind of going back to the way in which our primary endpoint is measured, right, we look at lesion size reduction over time. That is what we agreed on with the FDA, and that is the way we do the primary endpoint, analysis.

However, in secondary analysis, among many other things, we do a slope analysis, and, the slope analysis gives you exactly the same outcome as you get for the measurement of loss over time, but close to exactly the same.

We started on a high level leadership sales position recruiting and we had over 400 resumes come in for those positions. So you can see the interest within the industry on the potential excitement around <unk>.

You make a very important and, in my opinion, really critical point, which is also the slope, can be measured in various ways. You can go from, for example, over one year from 0 to 12 months.

You can go from 0 to 6 months, 6 to 12, or you could even go from 12 to 18, the way we, That is important because the slope gives you an idea of what we expect over time and how consistent the measurements are among each other.

It is contextual tool to understand, what the long-term impact of treatment is on patients.

And what we showed with the 18 month data in March, is that if you take it and through this piecewise, linear slope analysis from zero to six, six to 12, and 12 to 18, that these effects seem to be compounded, right?

And if I have geographic accuracy today, it's not that important how bad my disease was two years ago or 18 months ago. I care about what it is like now, because that is what I will in all likelihood carry forward as long as I stay on treatment, right?

<unk> or so.

That answers your question please.

Yes. It does thank you thanks for taking my question.

Thank you.

And our next question comes from the line of Derek <unk> with Wells Fargo.

Hey, Thanks, and good afternoon, and thanks for taking the questions maybe just shifting gears to <unk> for a SEC just to your questions. I mean first I guess, how has the <unk> patient mix trended in terms of naive versus five switches since launch. So that's question number one and the second question.

<unk> I guess can you talk to what the competitors are doing in this market right. Now are you starting to see some more counter detailing.

Since you've been in the market for now.

Several months.

That would be helpful. Thanks.

Thank you Derek this one too I will hand, it over to Adam.

Yes. Thanks, Derik. Thanks for the question so not a surprise we are finding the C. Five inhibitor switch patients continue to be the majority of our antibody stores and as a reminder, <unk> 1500, <unk> five treated patients within the U S and 150 treatment naive patients give or take.

Again consistently 75% of the switches are coming from <unk> patients.

That just tells you that benefit that people see <unk> treatment over a <unk> five trillion.

We're also seeing patients with hemoglobin levels.

And all that have experienced the benefits of <unk> pay.

Patients from this group will still potentially suffer from symptoms such as jaundice and fatigue.

And so we're seeing that the high levels of hemoglobin and now entering the market and asking to switch and switching to antibody. We continue to see treatment naive patients come in as well to have the valley and they are also benefiting from the significant increase in hemoglobin.

As we get later into the launch of this year I expect us to continue to build on the <unk> switch population to continue to drive higher hemoglobin in patients on <unk> two <unk>.

And I expect the treatment naive patients to also increase so.

I think we're getting a hole.

Some patients within the market.

Benefiting from switching to a P value.

Now the second part of your question competitors and what we're seeing.

So one thing I will say Eric is we are laser focused on executing our plan and for me. That's best practices. We as we launch into these ultra rare diseases to make sure that we offer the best solutions for empathetic patients at wholesale.

Colleges and oncologists that are willing to put patients on a fair value. So we we try and make sure that when we hear about competitors and everything thats happening in the market that we just stay true to our plan, which is we want to elevate the standard of care for <unk> patients. So we have not surprisingly.

More action and noise from from various companies, but again, we are determined that we have the best products and we believe that we can have the best impact on.

On patients so we're going to continue to execute our plans. So we tend to.

Listen to the noise ignore it and stay focused and true to what we wanted to execute in the market.

Got it thanks, guys. Thanks Adam.

Thank you and our next question comes from the line of Uganda, The Joe <unk> with Citigroup.

And in that sense, the 12 to 18 month data, looked very good with data much more consistent between Derby and Oaks, for example, at the beginning of the study.

Hi, et cetera contain thank you very much for taking the question Patrick I had a question on FX.

Great, thank you.

Okay.

So obviously extra program. The data are very very strong for both Oaks and Derby sofa.

That's really interesting.

So portfolio the situation I think that was a bit more complicated since the data looked really good or not.

Not quite as good in Derby, though of course on a core basis.

Sure.

No not really.

That's like 18 months, so with that being said what is your level of confidence you can get claims to fulfill in the label and more to the point how mission critical the OBL claim given that these patients are ready have irreversible central vision loss and one we're gonna docs will have more opportunities to save vision, but they can start.

Treating patients with the <unk> extra peripheral lesions.

And on a potential GA launch, how much focus will be on retina specialists that are already seeing probably more advanced GA patients and how much focus will be on educating optometrists or general ophthalmologists on referring earlier stage GA patients to specialists?

Yeah, thank you so much, Colleen.

I'm going to hand that one over to Adam.

Thank you so much you got so that's a very good and in enforcing question.

Because I think it's worth briefly speak about these COVID-19.

Mobile involvement so.

Toby lesions are leased up.

As you know sits centrally in the sector.

Yeah, and therefore have a dramatic.

On the Covid as.

As opposed to extra food conditions, where the central vision is preserved.

Bruce.

Thanks.

Newly diagnosed patients with <unk>.

Sure.

Diagnosed initially with extra formulations.

For the reasons that we don't fully understand.

Yes.

Protected until the very very.

The progression so it is a fair assumption.

Patients you could think of it as more expensive compared to those locations.

The early people want it.

Advanced patient even with homes.

Homes involved.

Can still relies very heavily on whatever retina is available to them outside of the scope yet so those patients when they get to that same point you don't want to stop dosing. We're treating no. If anything you want to you you may want to consider being even more aggressive because these patients are the ones that are really using the most.

Most quickly so to your point in Derby.

They did.

Nacho lot of an effect.

In books.

Is it what's again most fascinating.

That seems so we're going to continue to follow that.

But the way in which that he was done on the primary endpoint is but it's.

Oh, okay.

Well fuel as well as express fulfill.

And once you start that.

What would you have to be careful with effective quarters that you're dealing with smaller patient populations, where <unk> can have a bigger.

Hum.

But our staffing will be on old patients the geographic split.

As well as extra Huawei.

Okay, great. Thanks.

And then just.

On the dosing regimen for <unk>. So as you know there doesn't appear to be a clear dose response between monthly and every.

The other months as for example, the extra fulfill every other month and monthly dose responses are inverted between Oaks and Derby. So I'm. Just wondering is there any credence to the argument that the agency should only approve every other month given comparable efficacy to monthly and then incrementally corner.

Our safety profile, a nuance that T&D.

Disagree with that assertion and believe both scheduled merit approval.

Yeah, So we look at where both.

But every other month dosing scheme, but I think especially for patients with extra for few lesions at the beginning of the disease, you know who want to preserve as much as possible. If you end up getting 80% to 90% of the benefits of monthly injections by doing every other amongst that.

That is desirable if you start early and you want to get as much as possible over the long run. So we think that is very important piece of our filing. There is also the 18 month data that we have so not just 12, but we have this full data package on the 18 months, both on safety as well as efficacy and then of course as we discussed earlier.

Kind of the improving effect profile that we see on these foveolate patients as well.

So I think that in terms of the dosing regimen. Both doses. We believe have the data necessary to get approved we do not believe that the safety profile of warrants limiting the label and we would like to provide as much flexibility as possible to the physicians so and.

Unfortunately, again, you don't get the full benefit threat.

Just touching as I did in the previous question on the every other month versus monthly.

And version in Derby that is related to the fact that we had you know rapidly progressing patients in the monthly arm. So if you look at the totality of the data monthly as a slight benefit over every other month without a doubt.

Thank you and our next question comes from the line of Eliana Merle with UBS.

Thanks, Colleen.

Thanks for the question.

Hey, guys. Thanks for taking the question just in terms of the G H sort of commercial landscape and any sort of pre commercialization kind of analysis that you guys are doing.

I guess, what data do you have or sort of whats kind of your latest understanding of sort of that number of patients that might be diagnosed today, just given sort of no available treatments. So maybe not.

Vantiv to accurately diagnose and how youre thinking about that.

Just as we all kind of ran sort of standard kind of model in terms of the number of patients that might be out there with G. I.

Thank you so much.

That one over to Adam as well.

So a quick little reminder, right?

Thanks Sally.

A quick refresh us obviously 5 million patients worldwide million alone in the U S. Now and all discussions we had the retina physicians we've.

We've gone to a level, where a lot of retinal physicians believe that that number is actually greater than one 1 million patients because all patients that might not make it to their retina central to injecting ophthalmologists or something like that so I think if you speak to the experts within the field that will tell you that number could be it.

Could be higher than that so for all intents and purposes, we're focusing on that $1 million and we're looking at various ways, including targeting certain optometrists and ophthalmologists to allow that drive of the patient.

So we'll target around 3,000 retina specialists, and some optometrists as well, right?

To drive patients who are unaware, that there's a treatment to a retina specialist.

<unk> as a potential treatment on the horizon, two and injecting retina specialists, we're also exploring various ways through digital footprint.

So our focus is on the target list of about 3,000.

Education and awareness.

To really make it known to patients through various channels, but they could and should potentially see that retina specialists are injecting position. So we've looked at we've looked at a lot of those type of activities. We have plans around that we do think it's going to be important to make sure that we can drive patients to injecting physicians.

Hopefully that answers your question.

That's helpful. Thanks.

Thank you.

But an interesting piece of information, right?

And our next question comes from the line of Joe Stringer with Needham <unk> Company.

About 900 retina specialists do about 85% of all of the individual injections for anti-VEGF. So it's a really, really concise group, of retina physicians that do the bolus of the injecting.

So it's a very easy target for us, to go and introduce ourselves to and start to build commercial relationships with.

Hi, good afternoon, thanks for taking our questions one on <unk>, obviously, you've added based on your start forms 25 for the last.

Over the last few quarters.

Just curious if you see this sort of.

Sort of reaching sort of a status.

Steady state.

Were there any impacts on start forms.

<unk> co.

Covid related.

<unk>.

In in <unk>.

Just on the compliance rate.

It remains quite high.

Do you still expect this to remain this high or where do you see the compliance rates sort of.

Leveling out and thanks for taking our questions.

Thank you Joey Adam.

As we said on the call, we started to onboard several of our leadership positions across commercial, medical affairs, sales, and marketing.

Yes, Thanks Joey.

So I think we believe that we're going to see consistent growth quarter over quarter in an ultra rare disease like <unk>, it's incredibly encouraging that we continue to see that demand.

And interestingly enough, we've started our high-level leadership sales position recruiting, and we had over 400 resumes come in for those positions.

To your point Joey in light of the COVID-19 restrictions, which thankfully we're seeing now as we exit the first quarter lifting a little bit and access is improving for sure.

So you can see the interest within the industry, on the potential excitement around our RGA launch.

So hopefully that answers your question, Colleen.

Yes, it does.

That allows us to get back into the physician's offices.

Train patients more frequently face to face.

Do you expect some fluctuation when it comes to stop phones right.

As of January February and March for an approved product right. So we're learning the seasonality we're letting the impact.

But I'm pleased with the consistent demand that we're seeing when it comes to start forms. Another good metric for everyone to think about as we continue to see Rems certifications and programs increase that we had over 170 <unk> physician sign up for Rins Rins program that continues to grow.

And that's another another good sign for everything.

That's coming back.

So more to come I expect the demand to continue everything we're hearing from physicians and patients points in that direction.

Thank you.

Great. Thank you.

Thank you and our next question comes from the line of Laura Chico with Wedbush Securities.

Thanks for taking our questions.

Thank you.

And our next question comes from the line, of Derek Archilla with Wells Fargo.

Hey, thanks, and good afternoon.

Good afternoon. Thanks for taking the question I kind of wanted to follow up on one on the commercial side for G E and I think he discussed this a little bit but what is the capacity of the system in the U S to treat.

Thanks for taking the questions.

Maybe just shifting gears to PNH and Empedeli for a sec.

I V T injector to handle IV injections by ophthalmologists and retinal specialists I'm just trying to understand how.

How many patients could feasibly be treated.

More at a peak period, but as we're ramping up and then kind of related to that what would be the timeline to obtaining a J code and just curious how that might impact I'll take during the prior during the period prior to issuance of the J code.

Thank you Laurent those are two excellent question I'm going to hand, it over to Adam, but very briefly on the capacity levels.

Just two questions.

First, I guess, how has the Empedeli patient mix, trended in terms of naive versus C5 switches since launch?

So that's question number one.

One of the things that is that is really great is that the infrastructure there.

Reimbursement model.

You know the habits that retina doctors have of administering anti VEGF product is of course.

And then second question, I guess, can you talk to what the competitors are doing in this market right now?

Perfect point of entry for Us right.

The fact that we're talking about the capacity rather than capability.

Is it great points for us to start from because all of these physicians. These retina docs are used to managing inventory the buy and bill model that is typical for these products.

And we are.

Slowly entering into a phase where with Endesa just injections everything goes towards fewer anti VEGF injections were less frequent dosing will hopefully become possible. So in many ways you know it is.

There is a scenario here, where the introduction of our product.

If and when it occurs would help us.

Kinda fill what would otherwise be avoid that gets created but less frequent dosing I meant that interest, but it Adam I'm going to hand, it to you to talk more about that as well as to comment on the J code. Please.

Are you starting to see some more counter-detailing, since you've been in the market for now more than several months?

That would be helpful.

Thanks.

Thank you, Derek.

Yeah, Thanks, Patrick and Thanks, Laura I guess, Patrick you said, it very well I mean, we did some capacity research.

This one too, I will hand over to Adam.

Yeah, thanks, Derek.

Thanks for the question.

Last year on on our products and one thing, we found consistently et cetera et cetera.

Retina physicians know how to make sure that they can get their patients and then treated with the wet AMD is a great analog but they also consistently told us that.

They they knew what it would take to allow them to improve that capacity.

But when you see a technician to help onboard patients. So they already have started to think of plans should capacity be an issue. So.

I think the capacity is going to be an issue, which I don't expect it will be.

Earlier on in the launch phase window as people are getting <unk>.

Products approved as potentially and then people are starting to identify patients and bring them in so I think in the initial phase of the launch window. That's when we would see any headwinds that but we have plans on how we can help do that and we have a pretty good piece of robust research that helps us do it so often tied to your second part of your question.

Alright, I'm J codes, so obviously.

A little bit of a refresher for people.

Only use physician administered drugs like this one that fell through miscellaneous J codes. So we expect at launch.

That we would have that type of miscellaneous J code and then well.

Work with CMS and permanent J codes are awarded.

Most people know on a quarterly basis January April July and October of <unk>.

With my head.

And we understand the impact of that right. So we understand that provide is it going to be relatively sensitive around uncertainty of reimbursement for these type of drugs.

And so therefore, I think they're going to take that into account as they look in the early stage of the launch until a permanent J code becomes effective for them.

We're looking also based on the.

The question, we're looking at various ways that we can help support that provide a confidence.

Prescribing.

Product as quickly as possible and we'll obviously apply and obtain a permanent J code to help it said it would take all of the claims processing and payments and I expect that to be within hopefully six to nine months of approval. So that's that's where we stand on all things J code.

Thanks, guys.

Thank you. Thank you.

So, not a surprise we're finding that C5 inhibitor, switch patients continue to be the majority of our EmpaValue staff.

And as a reminder, you know, there's 1,500 C5-treated patients within the U.S. and 150 treatment-naïve patients, give or take.

I'll now turn the call back over to CEO Cedric Francois for any closing remarks.

Again, consistently, 75% of the switches are coming from ultramarous patients.

And that just tells you that the benefit that people see of a C3 treatment over a C5 treatment.

We are also seeing patients with hemoglobin levels near normal that have experienced the, benefits of EmpaValue.

Patients from this group will still potentially suffer from, you know, symptoms such as jaundice and fatigue.

And so we're seeing that the higher levels of hemoglobin are now entering the market and asking to switch and switching to EmpaValue.

Thank you.

We continue to see treatment-naïve patients come in as well to EmpaValue, and they're also benefiting from the significant increase in hemoglobin.

And our next question comes from the line of Yagal Nachomovitz with Citigroup.

Thank you very much and in closing thank you all for joining US today, we look forward to keeping you updated on our progress in the months ahead.

So as we get later into the launch of this year, I expect us to continue to build on that C5 switch population to continue to drive higher, hemoglobin patients on C5s to C3 to EmpaValue.

Hi, Cedric and Dean.

And I expect the treatment-naïve patients to also increase. So I think we're getting a whole mix of patients within the market that are benefiting from switching to EmpaValue.

Thank you very much for taking the question.

Now, the second part of your question, competitors and what we're seeing.

Cedric, I have a question, on effect sizes for extrafovial and foveal subsites.

So one thing I'll say, Derek, is we are laser-focused on executing our plan.

So obviously, in extrafovial, the data are very, very strong for both oats and derby.

And for me, that's best practice as we launch into these ultra-rare diseases to make sure that we offer the best solutions for EmpaValue patients and also hematologists and oncologists that are willing to put patients on EmpaValue.

So for foveal, the situation, as you know, is a bit more complicated since the data look really good in oats but not quite as good in derby.

So we try and make sure that when we hear about competitors and everything that's happening in the market, that we just stay true to our plan, which is we want to elevate the standard of care for PNH patients.

Though, of course, on a pool basis, foveal still shows a very solid signal and is not an excessive 18 months.

So we have, not surprisingly, seen more action and noise from various companies.

So with that being said, what is your level of confidence you can get claims to foveal in the label?

But, again, we are determined that we have the best products and we believe that we have the best impact on patients.

And more to the point, how mission critical is a foveal claim given that these patients already have irreversible central vision loss and won't retinodocs, will have more opportunities to save vision if they can start treating patients with the extra foveal?

We are around later today and tomorrow, if any additional questions feel free of course to reach out to Meredith.

So we're going to continue to execute our plan. So we tend to listen to the noise, ignore it, and stay focused and true to what we wanted to execute in the market.

Thank you so much, Yigal.

Got it.

So that's a very good and an important question, because I think, it's worth briefly speaking about this foveal involvement. So, foveal lesions are lesions that, as you know, sit centrally and have affected the fovea and therefore have a dramatic effect on the tissue, as opposed to extra foveal lesions where the central lesion is affected.

Thanks, guys.

Newly diagnosed patients get diagnosed initially with extra foveal lesions, because there is, for reasons that we don't fully understand, the fovea is often protected until the very, very end of the disease progression. So it is a fair assumption that foveal patients you should think of as more advanced patients, compared to extra foveal patients, particularly the earlier ones.

Thanks, Adam.

Those advanced patients, even when fovea becomes involved, however, can still rely very heavily on whatever retina is available to them outside of the fovea.

So those patients, you know, when they get to that time point, you don't want to stop, dosing or treating.

You know, if anything, you may want to consider being even more aggressive, because these patients are the ones that are really losing the most tissue most quickly.

So to your point, in Derby, the foveal patients, you know, did not show a lot of an effect.

Wonderful rest of the week.

In Oakes, they did, and once again, it's most fascinating to see how over time that seems, to be the case.

So we're going to continue to follow that.

Ladies and gentlemen, this concludes today's conference call.

But the way in which study was done on the primary endpoint is we included all patients with foveal, as well as extra foveal.

Thank you for participating and you may now disconnect.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating and you may now disconnect.

And once you start diving into the population, you always have to be careful with the fact, of course, that you're dealing with smaller patient populations, where retina effects can have a big impact.

So to be continued, but our finding will be on all patients with geographic foveal, as well as extra fovea.

Okay, great.

Thanks.

And then just on the dosing regimen for pegcidipoprine and GA.

So as you know, there, you know, there doesn't appear to be a clear dose response between monthly and every other month.

As for example, the extra foveal every other month and monthly dose responses are inverted between Oakes and Derby.

[music].

So I'm just wondering, is there any credence to the argument that the agency should only approve every other month, given comparable efficacy to monthly and an incrementally cleaner safety profile on new onset C and D?

Or do you disagree with that assertion and believe both schedules merit approval?

Yeah, so we look, we're very excited about every other month dosing schedule, right? I think especially for patients with extra fovea lesions at the beginning of the disease, you know, we want to preserve as much as possible. If you end up getting, you know, 80 to 90% of the benefit of monthly injections by doing, every other month, you know, that is desirable if you start early and you want to get as much as possible over the long run.

So we think that is a very important piece of our filing.

There's also the 18 month data that we have.

So not just 12, but we have the full data package on the 18 months, both on safety as well as on efficacy.

And then of course, as we discussed earlier, kind of the improving effect profile that we see on these foveal patients as well over time.

So I think that in terms of the dosing regimen, both doses, we believe have the data necessary to get approved.

We do not believe that the safety profile warrants limiting the label, and we would like to provide as much as flexibility as possible to the physicians.

So, and importantly, again, you don't get the full benefits, right?

Just touching as I did in the previous question on that every other month versus monthly inversion, in Derby, that is related to the fact that we had, you know, rapidly progressing patients in the monthly arm.

So if you look at the totality of the data, monthly has a slight benefit over every other month without a doubt.

Thank you.

And our next question comes from the line of Eliana Merle with UBS.

Hey, guys.

Thanks for taking the question.

Just in terms of the GA sort of commercial landscape and any sort of pre-commercialization, kind of analysis that you guys are doing, I guess what data do you have or sort of what's, you know, kind of your latest understanding of sort of the number of patients that might be undiagnosed today, just given sort of no available treatment, so maybe not an incentive to actively diagnose and how you're thinking about that, just as we all kind of run sort of the, you know, standard kind of model in terms of the number of patients that might be out there with GA.

Thank you so much, Ellie.

I will hand that one over to Adam as well.

Thanks, Ellie.

So a quick refresher.

So obviously 5 million GA patients worldwide, a million alone in the US.

Now in our discussions with retina physicians, we've got to a level where a lot of retina, physicians believe that that number is actually greater than 1 million patients because of patients that might not make it to their retina center or to an injecting ophthalmologist or something like that.

No.

So I think if you speak to the experts within the field, they'll tell you that number could, be higher than that.

[music].

So for all intents and purposes, we're focusing on that 1 million, and we're looking at various, ways, including targeting certain optometrists and ophthalmologists to allow that drive of the patient, now that there's a potential treatment on the horizon, to an injecting retina specialist.

We're also exploring various ways through digital footprint, disease education, and, awareness to really make it known to patients through various channels that they could and should potentially go and see their retina specialist or injecting physician.

So we've looked at a lot of those type of activities.

We have plans around that.

We do think it's going to be important to make sure that we can drive patients to injecting, physicians.

So hopefully, Ellie, that answers your question.

That's helpful, thanks.

Thank you.

And our next question comes from the line of Joey Stringer with Needham and Company.

Hi, good afternoon.

Thanks for taking our questions.

One on P&H, both that you've added based on your start forms, 25 over the last two quarters.

Just curious if you see this sort of reaching sort of a steady state, and were there any, impacts on start forms, COVID-related, in OneQ, and just on the compliance rate remains quite high.

Do you still expect this to remain this high, or where do you see the compliance rate sort, of leveling out at?

Thanks for taking our questions.

Thank you, Joey.

Adam?

Yep, thanks, Joey.

So I think we believe that we're going to see consistent growth quarter over quarter, in an ultra-rare disease like P&H.

It's incredibly encouraging that we continue to see that demand, especially to your point, Joey, in light of the COVID-19 restrictions, which thankfully we're seeing now as we exit the first quarter, lifting a little bit and access is improving for sure.

So that allows us to get back into physicians' offices and train patients more frequently, face-to-face.

I do expect some fluctuation when it comes to start forms, right?

This is our first January, February, and March for an approved product in EmpaVe, right?

So we're learning the seasonality, we're learning the impact.

But I'm pleased with the consistent demand that we're seeing when it comes to start forms.

Another good metric for everyone to think about is we continue to see RAMS certifications, and programs increase.

So we had over 170 physicians sign up for our RAMS program that continues to grow.

And that's another good sign for everything that's coming there.

So more to come.

I expect the demand to continue.

Everything we're hearing from physicians and patients points in that direction.

Thank you.

And our next question comes from the line of Laura Chico with Wedbush Securities.

Good afternoon.

Thanks for taking the question.

I kind of wanted to follow up on one on the commercial side for GA. And I think you discussed this a little bit, but what is the capacity of the system in, the U.S. to treat IVT, or to handle IVT injections by ophthalmologists and retinal specialists?

I'm just trying to understand how many patients could feasibly be treated more at a peak period, but as we're ramping up.

And then kind of related to that, what would be the timeline to obtaining a J-code?

And just curious how that might impact uptake during the prior, during the period prior, to issuance of the J-code.

Thanks.

Yeah.

Thank you, Laura.

Those are two excellent questions.

I'm going to hand it over to Adam, but very briefly on the capacity level, I think one, of the things that is, that is really great is that the infrastructure, the reimbursement model, the, you know, the habits that retinal doctors have of administering anti-VGF products is of course kind of a perfect point of entry for us, right?

The fact that we're talking about capacity rather than capability is a great point for, us to, to start from because all of these physicians, these retinal docs are used to managing inventory, the buy and build model that is typical for these products.

And you know, we are slowly entering into a phase where with anti-VGF injections, everything, goes towards fewer anti-VGF injections where less frequent dosing will hopefully become possible.

So in many ways, you know, it is, there is a scenario here where the introduction of, our product, you know, should, if and when it occurs, would help us kind of fill what would otherwise be a void that gets created by less frequent dosing on anti-VGF.

But Adam, I'm going to hand it to you to talk more about that as well as to comment on the, J-code, please.

Yep.

Thanks, Cedric.

And thanks, Laura.

Yes, Cedric, you said it very well.

I mean, we did some capacity research last year on, on our product and one thing we found, consistently, as Cedric said, is that, you know, retina physicians know how to make sure that they can get their patients in and treated with the wet AMD as a great analog.

But they also consistently told us that they, they knew what it would take to allow them, to improve that capacity, be it a new bed or a new seat or a new technician to help onboard patients.

So they already had started to think of plans should capacity be an issue.

So I think if capacity is going to be an issue, which I don't expect, it will be earlier, on in the launch phase window as people are getting, you know, their products approved potentially and then people are starting to, to identify patients and bring them in.

So I think in the initial phase of the launch window, that's when we would see any headwinds, there.

But we have plans on how we can help do that and we have a pretty good piece of robust, research that helps us do it.

It's also tied to your second part of your question around J codes.

So obviously, you know, a little bit of a refresher for people, all new physician administered, drugs like this one, they're built through miscellaneous J codes, right?

So we expect at launch that we would have that type of miscellaneous J code and then, we'll work with CMS and permanent J codes are awarded, as probably most people know, on a quarterly basis, January, April, July, and October off the top of my head.

And we understand the impact of that, right?

So we understand that providers are going to be relatively sensitive around the certainty, of reimbursement for these types of drugs.

And so therefore, I think they're going to take that into account as they look in the, early stage of the launch until a permanent J code becomes effective for them.

We're looking also based on the capacity question, we're looking at various ways that we can help support that provider confidence in prescribing our product as quickly as it's possible, and we'll obviously apply and obtain a permanent J-code to help facilitate all of the claims processing and payment, and I expect that to be within hopefully six to nine months of approval.

So that's where we stand on all things J-code.

Thanks, guys.

Thank you, Laura.

Thank you.

I'll now turn the call back over to CEO Cedric Francois for any closing remarks.

Thank you very much.

And in closing, thank you all for joining us today.

We look forward to keeping you updated on our progress in the months ahead.

We are around later today and tomorrow.

If you have any additional questions, feel free, of course, to reach out to Meredith and have a wonderful rest of the week.