Q3 2022 Apellis Pharmaceuticals Inc Earnings Call
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Hello, and thank you for standing by.
Welcome to the Q3 2022 appellate Pharmaceuticals earnings conference call at.
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I would now like to hand, the conference over to your Speaker Meredith Kaya.
Vice President of Investor Relations and strategic Finance. Please go ahead.
Good afternoon, and thank you for joining us to discuss.
Third quarter 2022 financial results with me on the call our co founder and Chief Executive Officer, Dr. Cedric Francois Chief Commercial Officer, Adam Townsend, Chief Medical Officer, Dr. Federico Gretzky, and Chief Financial Officer, Tim Sullivan.
Before we begin I would like to point out that we will be making forward looking statements that are based on our current expectations and beliefs.
Statements are subject to certain risks and uncertainties and our actual results may differ materially.
Courage you to consult the risk factors discussed in our SEC filings for additional detail now I'll turn the call over to Patrick.
Thank you Meredith and thank you all for joining us today, let.
Let me start this call with what is on all of our minds right now, which is our decision to submit a 24 month efficacy data from the phase III studies.
Studies.
This submission will be considered a major amendment to the NDA.
Ending a review time by three months with a new <unk> in February 2023.
Let me just state upfront, yes, we agree.
So many questions about this.
This decision was ours.
It has not requested by the FDA.
The reason why we decided to do this is because including these efficacy data.
There's the opportunity to have the best product profile that launch with minimal impact to our launch timing.
Recall that they already had the 24 months safety data as far as the 120 day update.
The inclusion of these additional data in the label would allow us to better educate physicians and patients with a clear message around the robust treatment effect that goes on over the full three year period.
Remember at 24 months those every other month and monthly treatments with Cooper.
Delta and meaningful slowing <unk> progression with increasing effect overtime.
Between months ATM in 2004.
Studies show these exercises of 24%.
30%, respectively with every other month and multi tree.
Unfortunately.
24.
The data were remarkably consistent between Derby and Oaks.
Meaning that we can spend more time discussing the efficacy of the two studies rather than the differences between them.
And we continued to see a favorable safety profile in over 200 patients with nearly 12000 injections.
Now let me talk about why we did this now.
We recognize the Peirce unusual given how close to our original two sided.
At the time of our 24 months top line readout in August .
How strong the data, where we had the discussion internally as to whether we would file a major amendment.
We decided against it because we believe that it will delay the timing of our launch and the timing of our permanent J code.
Months.
We also did not expect it to 24 months data package to be completed before the btu fab without compromising the European filing deadlines.
However.
As we continued to prepare for the launch some of these factors changed.
The completion of our 24 month data package happened faster than we expected.
Putting us in a position to submit the data.
Prior to RFP do that without stealing our European filing.
Also given the December holidays changes to medical coverage at the start of the year and finalizing the supply and logistics. We have already made the decision to launch in January which also meant that we would receive our J code in October .
The combination of these factors meant that the impact of the extended review period with only be six weeks delay to commercial launch with no impact on vehicles timing as the best possible Nagel.
The FDA is aligned with our decision to submit these data.
We understand that this gave us a surprise and we.
Did not take this decision lightly.
There was a significant unmet need in this disease and patients are waiting for a treatment.
But we also strongly believe that this is the right decision.
It is the fastest way to get our 24 month data into the label and to deliver the best product profile to physicians and patients.
The U S approval is the first step in our overall strategy to bring packages that goes onto gea patients around the world.
We remain on track with our EU marketing authorization application.
And plan to submit alright.
By the end of this year.
Turning now to the rest of the business.
Privately launch continues to progress well in its second year on the market.
With U S product sales of $17 7 million in the third quarter.
Globally, our partner Sylvie.
So making progress in bringing our stuff they need to be built with PVH.
Beyond <unk>, we continue to advance and poverty as it comes.
Affirmative therapy for other rare complements driven diseases.
<unk> based gene therapy products and <unk>.
Degenerative conditions.
And our early stage pipeline, including both our collaboration with beam and our internal programs continue to advance.
And with that I will turn it over to Adam.
Thank you Cedric.
I will start with our commercial plans for <unk> and then.
The team is excited by the potential of having the 24 month data in the label at launch.
I shouldn't perceptions that these data has been very strong based on both the recent market research and direct feedback we've been receiving as recently as last week at the Retina Society meeting.
And any launch the label is the most important documents that you can have having.
Having that 24 month data included in the label allows us to have a more impactful compensation with the physician.
And that's how they think about using <unk> and allows them to have a more meaningful conversations with their patients.
With a minimal launch delay it became clear that including these data in the application was the right decision.
We have approximately 100 people across our commercial and medical teams currently engaging with retina specialists.
Working to build a sense of urgency around <unk>, but through disease state awareness and education.
We will continue this disease state education until approval.
I am impressed with the talent of our expanded team who come from both large and small companies have brings significant expertise in launching new drugs within the retina.
They are incredibly motivated to bring the first and only <unk> therapy to market.
Now, let me turn to our current cholesterol product.
And prevailing.
In the third quarter, we continue to see positive trends across the key leading indicators for this patient population.
Including approximately 30 start forms 40, additional physicians, receiving rems certification high patient compliance rates and continued strong access amongst the top 20 payers.
This resulted in $17 $7 million in U S net product sales for the third quarter.
As mentioned on the last quarterly call following everybody. Its first year in the market. We have expanded our focus to the broader <unk> community by further positioning <unk> as first line treatment for EB.
Every adults living with PMA, which you could benefit from it.
As such we brought the full field team together during the quarter to focus on three key areas for the second phase of how much we.
We refined our target list of health care professionals. So that we can efficiently colon prescribers, who are treating the majority of <unk> patients.
We further evolved our partnerships with key centers.
As we realigned our field structure, including the addition of new team members.
We deployed the expanded field force in September and they are now fully engaging with the <unk> community.
Separately as a reminder.
N D with the phase III <unk> results and the 48 week Phase III Pegasus data has the Paducah date in February 2023.
If approved by the FDA this will allow us to further strengthen our.
Our promotion of <unk> for treatment naive patients and raise greater awareness of our long term efficacy and safety data.
Let me now turn the call over to 30.
Thanks, Adam, but thats been on everyone.
In August we announced we announced our longer term 24 months with thoughts with carbon and had the opportunity to share. These data at multiple ophthalmology Congress peaceful.
The medical team has been engaging with hundreds of renting specialties over these past few months.
Got upset the feedback on the data has been outstanding and the possibility of having them in the label at launch has been very well received.
Results in 24 months showed two highly consistent studies demonstrating that treatment with parts of the continent resulted in increase affects over time with greater reductions in admission growth from baseline to month 24.
These effects were observed across both the every other month and monthly treatment arms.
Then if you look at the combined data from Derby and Oaks exit the Copeland treatment showed an acceleration in the reduction in lesion growth specifically between month 18 and 24.
We reductions increasing to 24% and 30% in the every other month and monthly arms respectively.
Potential magnitude of benefit for patients could be substantial.
Within the same 18 to 24 months period exit the Copeland also appeared to be equally effective across both.
Non cell phone bill and subpopulations in both treatment arms.
Importantly, we continue to see a favorable safety profile consistent with what we saw at 12 and 18 months.
Safety data has now been collected over two years in over 200 patients in need.
12000 injections.
Turning briefly George systemic pipeline.
We are continuing to advance our rare disease franchise to deliberate on the broad platform and Bobby.
Which includes for later stage studies and multiple complement driven diseases.
A phase III study, we expected the Copeland in IC and PGN in CPG and the phase III study.
D C DMA or both.
In patients.
In October our partner <unk> announced the dosing of its first patient in the phase III study in Cala gluten indices or.
And finally, we remain on track to reported topline results from our potentially Registrational phase II study in <unk>.
Yes. It is.
2023.
Let me now turn the call over to Tim for a review of the financials.
Sure.
Thank you said it since we issued a press release earlier today with the full financial results I'll just focus on the highlights for the third quarter 2022 summarized here.
As you can see total revenue was $22 1 million, which consisted of $17 7 million and <unk> net product revenue and $4 4 million in collaboration revenue from <unk>.
R&D expenses were $95 2 million and G&A expenses were $78 4 million and we reported a net loss of $191 3 million.
As of September 32022, pellets at $708 6 million in cash cash equivalents and short term marketable securities.
Even with the shift in launch timing, we continue to expect our current cash balance to fund our operations into the first quarter of 2024, including the ongoing launch of empathy Ali the potential global launch of <unk> and further development of our pipeline.
We remain confident in our palaces financial future as we continue to execute on our upcoming milestones and with that I will now turn the call back over to Cedric for closing remarks et cetera.
Thank you.
This is an incredibly important time for our company our position in the <unk> market is expanding we are close to having a second commercial product available that we believe can have a life changing impact on People's lives and we continue to advance a robust pipeline encompassing multiple at this stage rare disease programs as well as pre.
Clinical programs heading into the clinic.
We are on track to achieving our vision of being the global leader in complement.
And Theres now open the call for questions operator.
Thank you at this time, we will conduct a question and answer session to ask a question. Please press star one on your phone and wait for your name to the EMR.
Please standby, while we compile the Q&A roster.
No Matt.
Mod, who Kumar of Goldman Sachs. Your line is now open.
Hey, Hey, Thanks for taking our question. This is Rob on for Madhu.
First what's the timeframe for submitting the 24 months' data to the FDA and how long after the submission should we expect to wait for clarity on the <unk> data and have an AD com is still necessary.
Thank you so much for that question so.
We and our discussions with the FDA again this is classified as an unsolicited submission or amendment.
We agreed with the FDA has asked if this was submitted before the current we do find is that we would get in <unk>.
<unk>.
Be sometime in the latter part of February .
So that is where we currently stand.
Okay. Thank you.
One moment please.
Our next question comes from <unk> Ahmad of CA and now.
Your line is open.
Hey, guys. Good afternoon, Thanks for taking my question.
Eric I was wondering if you could share any of the feedback that you might have gotten this weekend I know that you attended the retina Society meeting.
Since the press release with to that time for you to talk about it there just wondering what kind of reaction Scott from physicians.
When you mentioned that you would be applying now to have 24 month data in the label and then.
Secondly for the J code. If you participate does get pushed out to February when should we expect to see the permanent J code when you launch.
Thank you.
The feedback from the doctors I will hand, it over to Peter who was there with me as well, but it was overwhelmingly positive and again, we are doing this for the benefit of physicians ambitions and maybe you can elaborate a little bit yes.
But what's very positive about this weekend.
These dcs.
Geographic atrophy, having understanding the FX overtime as highly valuable.
Physicians.
Understand that.
They really welcome our decision and.
And the possibility of having all of our data 24 months in the label to start with.
And then for your second question on the J code, who we expect to have the J code early October .
Okay. Thank you.
Thank you.
Thank you one moment please.
John Miller of Evercore. Your line is open.
Hey, guys. Thanks for taking the question.
Uh huh.
I have a question have you been in labeling discussions yet with the FDA and.
So how is that being impacted by 24 month data and then secondly, previously you had mentioned that the agency was treating 18 months data as primary does that type of the trials were designed for 12 months as primary do you anticipate the FDA would instead treat 24 month data is primary now and how does that work statistically given.
While it wasn't pre specified at the later time points.
Thank you so much John so our discussions on this amendments pre empted the label discussions with the FDA so to be clear about that.
But again it was a very productive back and forth and direction as it relates to the primary endpoint. So we will have to see I mean this is of course.
Something that we that we hope based on language that we had before may indeed play.
Of course, the decision from the agency.
I understand.
Separately did you ever bring up questions around the micro perimetry data in any of your earlier discussions I asked because obviously that is another important difference between 18 and 24 month data.
Yes. Thanks, Sheila So we were very excited about as you may recall looking at the macro perimetry around the actualization space, where we had a signals for our functional impacts of the treatment.
But to be clear the primary endpoints in every efficacy consideration with the SBA was and continues to be showing that we can anatomically reduce the growth of the vision in these patients.
Okay. Thanks, so much.
Thank you John .
Thank you one moment please.
I know from Rama of Jpmorgan. Your line is open.
Hey, guys. Thanks.
Thanks for taking the question I thought maybe I'd throw the <unk> question that might get asked on this call.
On the <unk> for <unk>, just wondering what your market research suggests about how including those data from the Prince study might change the ramp curve.
The phenotype of the patient <unk> patient that is treatment naive that might initiate therapy. Thanks, so much.
Thanks, Greg.
We're going to end up on over to the other banks out of power gap. So obviously the team is thrilled with the progress on the antibiotic launches we go into phase III.
The supplemental NDA with the phase III Prince days. It just allows us to have an even more robust conversations with physicians about treatment naive patients and the benefit of switching to <unk>. So at the moment, we have about 10% of our patients are actually treatment naive patients and we expect that having.
A much more detailed conversation and the update that LIBOR will allow us to remind people that <unk> is the product of choice for the field based team is super excited to have.
That potentially in the label and I think we'll see some really strong progress there.
Thanks, so much for taking my question.
Thank you Erica.
Thank you one moment.
Phil Nadeau of Cowen Your line is open.
Good afternoon, thanks for taking our questions.
One question that we get all the time Cedric is.
Political Brendan and the filing is whether the filing was in any way in response to our proposed label, where maybe there are some elements that you didn't like I know you just said that you werent actually label negotiations, but have you seen.
Any proposed label from the FDA.
The first question and then second question during the prepared remarks, you mentioned that the 24 month data would broaden how doctors.
Think about using political Brian can you elaborate on that and what ways we will.
Well the 24 months David change how physicians could you just could you just the terrific. Thanks.
Okay. Thank you so as I mentioned earlier, so we went to the FDA.
This.
The proposed amendments.
Pre empted the label discussions right. So we proposed that we wanted to include the full 24 month data.
The FDA represents so it's important to point out that.
Charter agreements, we actually did run the press release that we issues on the subject.
Just to make sure that we were in full alignment.
And so this is the path that we chose which we believe will be the best interest of patients and physicians and Adam why don't you tell us why that is so important to yes, absolutely. Thank you Phil.
Obviously, the team and the whole of the pallets is actually excited about the 24 month data, particularly.
Efficacy increasing overtime more consistency between our two studies and the robust safety. So one of the thing that we've done is we've tested.
With retina specialists in the U S and ex U S. At 12 months 18 months 24 months and not as surprised in our market research the profile of the drug improved in that in that perception and 24 months, we got comments from rent, especially about how they are much more comfortable.
At about talking to a broader set of patients based on the efficacy profile of the drug and the consistency between the two studies. So I expect as we continue to do disease State education until launch that will have a physicians will have a much easier conversations with their patients and I would expect them to bring more patients into that.
<unk> as a result of the strong efficacy data that.
That's helpful. Thank you.
And just to.
Think about it this way right the Derby prep the trial that just a year ago ready for the issues that we're all familiar with in the <unk> analysis from the 18 to 24 of the most of the patients for the slope is at 36% slowdown in the growth and 29% for every other month so.
Just really important data for us again.
Importantly effect between months Aetna's 2004 generate that consistency is 24 months between the two studies and that is something that we find particularly important.
Perfect. Thanks for taking my questions.
Thank you one moment please.
Steven <unk> of Raymond James Your line is open.
Great. Thanks for taking the questions.
I wanted to go back to a comment you just made about running the press release by the agency to make sure Youre in full alignment.
Why why do we even need to give a press release.
Last week since this was an elective decision on your part and since as far as we can tell as of today you still have been submitted.
The 24 month data I mean, why not just announced that with earnings I'm curious what prompted the press release in the first place.
Yes, Thank you, Steve Retina Society right.
We do this for physicians and patients and the retina Society.
<unk> enforcement conference of the year.
After this one angiogenesis I'd say would be the next one which is already in February . So we wanted to have the opportunity to really speak openly about this with the retinal community.
Got it Okay, and then how much did competitive dynamics.
Specifically play into this decision so anticipating.
Potential competitor in <unk> being a market next year.
And how that might have changed or evolved.
Your view of the label and how.
That's going to position competitively and then also how much did a O and the feedback you got there from physicians play into this decision. Thanks.
So look we are we believe that we have a very exciting product profile at 24 months that we can bring to physicians that they can then communicate to patients.
Of course, we believe that that positions us well competitively.
These are decisions that are necessary.
Any color I mean, many factors go into it competition is just a small part of that but we wish.
Our competitors the best of luck as well as they've moved forward towards just lastly look are you answer.
Without this amendment would you have anticipated both the full deal subgroup and every other month dosing in the label, regardless or does this specifically enhance the profitability of both of those being included in the label.
Yes, it is yes.
Okay.
Alright, thank you for that and as it relates to <unk>. So let's look at the American Academy of Ophthalmology.
As you may recall that in the month of September we did the whole analysis to really better understand what's the functional impact was of these treatments, which as you know because these measurements are so complicated it can be difficult to do so at <unk>, we had very exciting data on the macro perimetry, but in the meantime, I think a little bit lost in the noise quite frankly was.
How good the 24 month data really was and.
And again something that we believe are fundamental society was a great opportunity to do that again, and we look forward to continuing that in the next year.
Thank you.
Thank you one moment please.
Chris Howerton of Jefferies. Your line is open.
Great. Thank you so much for taking my questions.
Yes. The first one I had was with respect to the 24 month data. If you guys could comment on the relative importance of those data being in the label itself versus a high quality peer reviewed journal article.
And then the second question is maybe just a clarification Cedric in terms of.
How does the conversations change at the retina society, because wouldn't they have already now in the 24 month data and it's really just their perception of it being in the label or another venue. So just help us understand the rationale there specifically thank you.
Thank you, Chris I'm going to hand, it over first to Adam to talk about the label versus article and White label separately.
Thanks, Chris Good to talk to you. So obviously, we have 100 field based employees outlet talking about disease State education.
Are they going to be our most.
Important voice as we get a potential approval.
The label in my experience is the most important document that we could ever have it at palace allows those field base teams to have a really robust compensation based on the label language with conditions. So I think that that critical mass for US here, we got a we got to make sure that those conversations are robust.
As possible and Thats quick hits, the device nimble way of getting the data out there to the 2600 retina doctors that we would target.
Obviously.
Publication of the.
The data also supports but we can move very quickly post approval to have those compensations live with physicians and that's our that's our priority.
Thank you Adam and therefore, the retina Society.
To us it was a risk number seven instead of maybe you want to elaborate a little bit on that.
So basically the conversation changes at the retina Society based on 24 months.
The implication there.
Was that for these doctors didn't know the data, but the ability to have a simplified message towards their patients for these retina docs is important.
It's important to point out as well that have retina society has to kols, but if you talk about the doctors that are actually practicing in rural America, and all the places where we need to go as well and transmit the message.
There will be incrementally important to have this available to us.
Okay. Thanks, so much.
Okay.
Thank you one moment please.
Colleen QC of Baird. Your line is now open.
Hi, good afternoon. Thanks for taking our questions can you comment on how you received the feedback from the FDA on the alignment for the 24 month inclusion was that in writing and how likely do you think it is that the FDA will accept the amendment and then just given the especially short timelines of the original timeline for your NDA review do you have a sense of if the FTE.
The review was tracking to schedule prior to this amendment.
Thank you so first of all with respect to the first question.
This was a very good conversation.
With E mail feedback specifically on the <unk>.
Press release that I mentioned earlier so.
This was.
A very smooth process to be honest with you and we expect there to be.
No issues in the weeks to come where we will submit and we will get you to defend it.
So then.
The second question is frequently because you were breaking up a little bit on review tracking.
Yes.
Do you have a sense of if the FDA.
If the NDA review is tracking to schedule prior to this amendment yes.
Yes. It was so it's worth mentioning here choline again.
This was a very concentrated reviewed timeline rates, but we had.
A priority review with the priority for the <unk> III NDA submission, which meant six months from the time of submission. So everything has to be squeezed into a very short timeline between the end of July .
Wow.
And that was as I've mentioned before very smooth process.
Within <unk>, yet the decision that we decided to defer this amendment.
That's helpful. Thank you and one quick follow up.
Does this change at all your thoughts on the likelihood of the FTA hosting an advisory Committee meeting.
It does not so there was no mention or discussion.
Got it.
Great. Thanks for taking our questions.
Thank you.
Thank you one moment please.
Justin Kim of Oppenheimer. Your line is open.
Hi, good afternoon. Thanks for taking the question, maybe just taking a step back and thinking about the landscape with some recent and upcoming data updates for systemic applications that compliment.
Curious if the team has any updated thinking on targeting Iga nephropathy crops with earlier stage modalities, such as an oral factor B and.
Any of the implications of some of the ESI RNA combo data at the upcoming at Ash as you think about getting into clinic also next year.
Thank you so much assistance.
As you know with Iga nephropathy is not a focal point for us.
Right now our neurology programs, RCP, Columbia, <unk> and immune complex new ground up really strategic limited on this crisis.
Alex intriguing with recycle plant of course, and we continue to look at that.
It's a further testament to the <unk>.
Both potential their customers can't control has across a wide range of therapeutic areas.
And yes, they are in there and Thats. Another program that we are very excited about and where we are now nearing up on that on the ANZ in the near future.
Okay. Thanks.
Thank you.
Thank you one moment please.
<unk> <unk> of Citi. Your line is now open.
Hey team. Thanks for taking my question. So I just wanted to follow up could you just elaborate a little bit in terms of what specifically happened internally at a pellet that enabled deregulatory into apparently accelerates the preparation of the full 24 month data, which obviously enabled you to move faster with the timeline as I understand.
Which then triggered a chain reaction, which allowed you to have more time to submit the 24 month data now is I think if I'm correct. The original expectation was that you were.
Would not be able to move quite as quickly as you ended up moving with the preparation of the 24 month data. If you could just help me sort that out that'd be great. Thank you.
So it was a combination of multiple sectors as we outlined in the script, but on one hand.
The launch timelines, which changed and which.
Were planned for the beginning of January and the first two weeks Moreland.
Then as you mentioned the fact that at least in September we did not want to prioritize the filing of an amendment over the preparation of the European filing, but all these things of course go hand in hand with each other filing of Europe move towards very well and very quickly and the possibility of doing an amendment with us.
Starting that effort became clear so when we realized that the only penalty to behavior was you know plus.
Plus or minus a few weeks six weeks.
The current plans for the launch without a delay on the J code and the <unk>.
The ability to file an amendment that was a strong message for us.
Of course combined with the fact that our commercial team in the meantime is working very hard and considered this to be very important.
Okay got it that makes a lot of sense and then maybe just to help everyone is less familiar with the J code process can you just explain specifically what's the reason why that six to seven week delay between starting on January one versus starting to launch on the.
Doesn't impact the timeline to getting the full permanent J code by October just can you just walk through the reason why that doesn't matter. Thank you.
Yes, Thank you Hugo.
Great question, so essentially permanent J codes issued by quarter.
And so to get the supply and logistics in place and be there on time to ship your first analysis what drives that.
That is what led us to realize over the past month or two months.
In all likelihood beginning of October was going to be the permanent J code for us and in that context launching in the first half for January of January or the second half of February does not make an impact or difference for the J code.
Got it okay. Thanks.
Thank you one moment.
Ellie Merle of UBS. Your line is now open.
Hey, guys. Thanks for taking the question just after all the interactions with the FDA can you just speak to your confidence that Ta lesion growth.
Considered an approvable endpoint I guess any reason to think that the FDA or someone within the FDA, even perhaps higher than Wiley chambers might be questioning the clinical meaningfulness or expressing any doubts and then just in terms of like the approval itself I guess, who has the FDA signed the ultimate approval is that sort of west Wiley chambers.
The ophthalmology division or could it become somewhat higher.
Thank you Eddie.
As far as we know nothing has changed so there has never been mentioned at all that there is a change in the approved ability or the process in house decent growth as the primary endpoint. So that is absolutely not something that I think anyone should be concerned about.
So then the approval process I believe.
Ken I'm kind of getting on the burden of how I understand the regulatory regulatory process to be but at the end of the day the division.
Makes the determination and Dr Chambers signs off on it and I believe that there is further sign of higher up in the FDA, but I don't think that that is.
Typically a place where we are.
Problems emerge.
Speak of it that way.
Understood. Thank you.
Thank you so much.
Thank you one moment please.
Annabel Sammy of Stifel. Your line is open.
Hi.
Taking my questions.
Prefer a little bit before but can you just help us understand whether the FDA is can be reviewing the 24 month data with any statistical rigor as it is the 18 month data.
Except that I guess is the primary endpoint or is it just going to be reviewed transformative purposes and then.
Based on the label for information. So you can talk about it I guess, if that's the case.
So why not just wait for a publication.
Because it seems like a lot of the physicians notice date already they've seen it multiple times now so I just want to understand.
How FDA is going to be looking at this data.
The other data that you have already submitted.
Yes of course, we are.
We're hopeful that that's.
The language that we got that 18 months makes us hopeful that the 24 months, mainly would be considered the primary endpoints. So.
That in combination with the strength of the data and again I cannot overemphasize, how powerful that increase the sector overtime is right. I mean, you are talking about getting into the ZIP code of 30%.
That's extraordinary breadth I mean, the fact that it increases the longer you treat these patients is a really important message and creates a lot of hope and remember I mean at least for now I think we still hope that that continues to go beyond year, two as well. The reason why this is the primary endpoints with the FDA.
Is that this is not a disease of two or one years. This is a disease, where ambitions are affected for five or 10 years, sometimes decades, right and the long term impact of this disease is terrible and were hoping to mitigate that.
So just to follow up on that are these.
I guess are these.
Patients.
Or is the.
Okay. Let me just step back how often does the FDA just change the endpoint.
Yes, that's the question.
It went from 12 months to 18 months to 24 months. So is the statistical rigor.
Hence at 'twenty four 'twenty formats, if it wasn't so much as it was at 12 months I guess.
That's another way of asking the question.
Only know and abilities to communications that will begin from the FDA right. So.
We don't write those rules.
B groh with Samsung.
It is.
That's all I can say.
Okay. Thank you.
Youre welcome.
Thank you one moment please.
Joey finger of Needham Your line is open.
Hey, Thanks, Vincent Chen or Joey Thank you for taking our questions. So.
Our first question is what is your current thinking on any potential partners shapes.
Either in the U S or ox you ask for Pepsico coal plant NGA and our second question is could you help frame expectations for.
<unk> phase two.
<unk> study next year, so what is the plan.
Clinical meaningfulness.
The.
<unk> primary endpoint.
With this trial potentially consider registrational. Thank you.
Thank you Zoe so on partnerships in geographic atrophy, we.
<unk> has been preparing to launch this product ourselves in the U S as well as the ex U S. So that has been our Atlantic continues to be our plan.
As it relates to the Lf study. This is of course, a high risk high reward study right. So.
The likelihood of meeting the primary endpoint in that study like old Elisa studies is going to be low, but should we need it of course, it would be of high.
Clinical and.
In human Meaningfulness for the company and for patients.
Okay. Thank you.
Thank you.
Thank you one moment please.
Douglas Tsao.
Wainwright Your line is now open.
Hi, good afternoon. Thanks for taking the questions a lot of my questions have been answered, but just curious centric in terms of the retina Society meeting I'm just curious.
In terms of feedback you got from physicians what.
Was it that the most were impressed by the 24 month data was it safety with it efficacy was the deceleration was it.
I'm just curious in terms of the feedback what or maybe said a different way.
What about it.
Did the 24 month data due to changed their perception that they already didn't think from the 18 month data. Thank you.
Thank you for that question because obviously this is why we did it right I mean the.
The data between months 18, Ensco DS four is absolutely remarkable and groundbreaking in the retina I mean, we are starting to understand how this drug works in this disease.
We're seeing that with those increased effects overtime again getting into the ZIP code of 30% slowdown 30% right.
Phase of those three years.
Incredibly important for these patients. We also are starting to see the functional impact right. On these micro previously analysis that we ran so all these things are important and last but not least of course something that was first presented at <unk>. We're on the OCC images in these patients. We can also specifically look at the <unk>.
At which photoreceptor cells are lost.
To really hone in on B cells that detect decision into retina, and where we have extraordinary.
Extraordinary resource as well so all of this was very positive and important and.
We are starting to really understand how this drug works and we look forward through this major amendments to being able to talk about many of these things and the label with the broader community.
And maybe just as a quick follow up centric also points. What was was there anything that really sort of captured the imagination of the physicians at the retina Society meeting.
Yes, so I would say with captured most of there you mentioned nation into discussions that we had was the work that was done this gets a little bit technical but the work that was done by our collaborator looks reversed estimates are for it in Austria, where again looking at these OTT images she looks at the floater receptor cell loss specifically.
So not the supportive so that you have in the retina and there in this blinded analysis that we did add to one year time points.
Both in Derby as well as in books, we had as much as approximately 75% saving of photoreceptor cells. So work that requires more to be done of course.
But I think thats recognize or looking at a depth of understanding of the mechanism works is very helpful and we'd like to add something to that as well, yes, Doug I just thought it would be interesting for you you.
Youre asking about the retina Society meeting, but also our 24 month data market research I'll summarize the overall feedback from that market research, which is with retina specialists key opinion leaders as well as those that potentially go to those type of meetings.
At 24 months, there was a really strong conviction towards the therapeutic effect in <unk>.
You may have missed that month 12 became irrelevant to those physicians that we used within the market research from an efficacy perspective, they were impressed by the longevity and the consistency of the efficacy curve separation across both studies and they started really appreciate the robustness of the clinical data.
And.
We continue to get quotes during that market research such as it is impressive that the effective treatment is increasing with time.
It's just really impressive we kept getting that impressive what was the one that came out.
The effect was already proven after six months, but with speaking about reductions of about 30%. After 24 months that type of feedback we consistently golf from a 24 month market research.
Okay, great. Thank you very much that's super helpful.
Thank you so much Doug.
Thank you Glenn.
Okay.
Our last question comes from Madhu Kumar of Goldman Sachs. Your line is open.
Hey, guys. It's traveling again just one other question. We had was is there any impact from the IRS inflation reduction act and moving the approval potentially back to 2023.
Thank you so much your double dipping here.
I like that.
So this was this was not a consideration in our decision making process.
And.
Look at it's understandable that this company needs it generates confusion.
But when the circumstances are there and they always evolve and they are never kind of one circumstance several things when we get to a point, where we truly believe that is going to be better for patients and for physicians.
Sometimes you have to make difficult choices and doing.
Doing it now close to the <unk> is not ideal but.
We believe is going to be serving us very well as the next year comps so.
Thank you for your question.
And is there anybody else after you.
Operator.
So that concludes our Q&A.
Thank you so much.
In closing thank you all for joining US today, we are around later today and tomorrow and if you have any additional questions. Please feel free to reach out to Meredith.
Thank you for your participation in today's conference. This concludes the program you may now disconnect.
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