The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: All right. So, a lot to talk about each of you have very interesting pipelines and products that are either close to the clinic or in late stage clinical
trials. So why don't we just go through and give a quick introduction. You know what the lead asset is in ophthalmology. And you know where
you, where you are as far as your your path to commercialization.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Very good.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Okay, great. So although each of you are sort of in different mainly non-overlapping areas except for your early program in AMD, you're improving
on an existing option in the case of presbyopia, in the case of dry eye, where there are many options, in the case of wet AMD, where there are also
a few options. So go through -- for each of you, just sort of explain the value proposition, for example, for LENS100, how is it advanced versus what
was attempted before. What's the value proposition, so people can understand why your asset is interesting.
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DECEMBER 05, 2024 / 6:45PM, ALDX.OQ - Aldeyra Therapeutics Inc at Citi Global Healthcare Conference
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Right?
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: So if you think about commercialization for, your three markets, I guess I would, characterize Eef and Todd, sort of in the same conceptual bucket
where the market is very big. 128 million. I don't think you referenced the number of dry eye, but it's a lot. And you don't need a large share to
command a nice revenue picture. On the other hand, for anti-VEGF, I think the numbers are the share of patients on an anti-VEGF amongst the wet
AMD, it's very, high if I'm not mistaken. So you have sort of, opposite issues that you want to achieve that very, high share to supplement the
efficacy. So as you think about commercialization, give us a sense as to how, you would attempt to, gain share where you don't need a lot of share.
But, even a small share is many 100,000 of--, if not millions of patients.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: And one follow up there if, when I speak with investors on-- it's given that it is largely a market that will be served by the opticians and the, ones
that are, providing eyewear, people aren't completely clear that you do need a prescription for this product and that you do need to have a retinal
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: And Todd, you just got the acceptance of the resubmission. So you're on the final stretch. So tell us about your commercialization plan.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: And just to follow up there, you mentioned dry eye, you mentioned AC. What's the thinking there, in terms of-- how you're going to prosecute this
marketing pitch? Do you need to talk about both because as we know the Venn diagram, there is nicely overlapping.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: It's a good word.
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DECEMBER 05, 2024 / 6:45PM, ALDX.OQ - Aldeyra Therapeutics Inc at Citi Global Healthcare Conference
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Okay. And, Fred, you have an ophthalmologic challenge but a different one, obviously with several approved products and there's continued
innovation in the space you're innovating, but you're not the only one. You know, we've seen the Bispecific approval with Vabysmo, we've seen
the-- EYLEA, we're seeing the TKI inserts. But, tell us what is your path, what is your approach to commercialization?
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: And then just to follow up on that in terms of, how you think about the practice dynamics and, you know, of course, as we know, as we learned
even yesterday from one of the experts, efficacy will rule the day. I mean, convenience is good but, efficacy is better. So, how do you think about
that? I mean, obviously it's a second injection. Do you have plans for co-formulations? How are you thinking about that?.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: It's a good point. If you want to talk a little bit more about your Direct to Consumer initiatives as well as how you're targeting eye care professionals.
I mean, you're going to be using a lot of channels to get the message out. You can't speak to all the details on the label yet, but you can be doing
some market awareness in terms of getting people to understand that they even have Presbyopic because they may not actually realize that it's a
disease or condition. So maybe talk a little bit more about that and you use leveraging social media and potentially some, influencers eventually
to do this.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Todd, maybe talk a little bit more because, you said at the beginning you're an immunology company with applications in the eye or something
to that effect. So, I can you go back and talk a little bit more about, aldehydes and aldehyde biology just at a high level and you know what you're
doing, beyond dry eye. You mentioned Retinitis Pigmentosa as well. So, talk a little bit about that. I think we understand we've got a very good
partner in (inaudible) so that box is checked.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: And Fred maybe. Can you talk also a little more about MOA and you know, not everyone's pretty familiar with the A and the B isoforms but VEGF-C
and D, how do you think about them in terms of, driving the disease?
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DECEMBER 05, 2024 / 6:45PM, ALDX.OQ - Aldeyra Therapeutics Inc at Citi Global Healthcare Conference
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: You have a very extensive Phase III program that the coast and the shore. One with EYLEA one with Lucentis. So just a few follow ups there. I mean,
obviously you did the Phase II with Lucentis. You made the point that these are very similar, the basic VEGFs are very similar anti-VEGFs are very
similar in how they behave. So, you know, just help us understand how you think about the outcomes here and also remind us when the data
because they're coming pretty soon, right?.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Okay. And then, one question. I don't get it as much these days, but I did get it early is obviously with the Phase II, you had a great result with the
2.0 mg with the 0.5 you know, it didn't really differentiate much from just Lucentis. So I mean, the answer, I've heard, it's normal, right? I mean, but
you gotta do dose exploration and that wasn't a high enough dose. But I guess when some people see the picture, they just wonder a little bit. So
maybe just help us understand that.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: Okay. And then just to wrap up, give us just a quick, over the next three or four quarters, what are the key milestones?, I mean you mentioned the
PDUFA day, but what other data sets or presentations of medical meetings or other milestones that we should be aware of from you, as everyone
anticipates the launch which I assume would be late 3Q or 4Q next year.
Question: Yigal Nochomovitz - Citigroup Inc. - Analyst
: And Todd quickly your milestones.
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