Veradermics, Incorporated ($MANE)

Okay. We're going to get going on our next session. Thanks for joining us. I'm Marc Goodman, one of the biopharma analyst at Leerink Partners, and we're lucky enough to have Veradermics with us, and we have the CEO, Reid Waldman. Thank you for joining us. Obviously, new company as being public entity. We started the coverage very recently, a story we like a lot, and it's really starting to resonate as we talk with people kind of live and everything. So anyway, thanks for joining us.

Maybe you can start with just how did you originate this idea? Where did it come from? And how did the company get going? Just give us a little sense of that first.

Yes. So it's easy to be really excited about hair loss as a dermatologist, right? It is the single most prevalent chronic dermatologic condition, and it is a condition that essentially transcends being aesthetic, it's deeply personal, it's deeply psychological and it's essentially universal for our patients, affecting 80 million people. And so again, the ability to get excited about the market was very clear to us. I think the question becomes how did we get excited about developing a Minoxidil extended-release tablet? And I became familiar initially with off-label use of oral minoxidil when I was reviewing articles from the Journal of the American Academy of Dermatology. And I started using it off-label. But fundamentally, as I came to recognize, the drug is a blood pressure medication and the way it performs in the body is exactly what you would expect for blood pressure medication. So it spikes very quickly, within 2 the majority is gone. Within 4 hours, almost all of it's gone. And while that's great for lowering blood pressure, it's intended purpose, it is not optimal for hair loss. So as we dove into the pharmacology of minoxidil, we came up with a thesis that we could optimize minoxidil for oral administration, maximization of hair growth and minimization of potential cardiac risks through an extended release tablet that provide consistent and durable exposures of minoxidil throughout the day at the follicle to drive hair growth in...

So this was when? When was this?

So we've been working on this product now for 4 or 5 years. So it's been a long journey to get to this point and then obviously...

So 4 or 5 years ago was the idea of what you're describing?

We started working very quickly after having the idea, we got very excited about the idea.

So where did you get the technology to make an extended release?

Yes. So we had started working with a number of different groups. And it's very interesting because, right, minoxidil in its oral form had not been really played with since the '70s, and as you might imagine, the characterization of minoxidil from the '70s was not modernized. And so much of what people thought they knew about minoxidil turned out to not be true when you try to formulate an extended release tablet. So through quite a bit of trial and effort, we were able to advance, identify a formulation that in vivo performed as we wanted to, took that into Phase II data, which was spectacular and now have 3 ongoing Phase III trials.

Right, right, right. So let's back up and talk about the Phase II data in a second. So give us a little sense of that program.

Yes. So in Phase II, we have put out male data, so males with androgenetic alopecia. And in essence, the profile that was shown is as follows. It was fast with visible results as early as 2 months. It was with an extremely high rate of clinically meaningful response among patients. It was intense with very strong objective and quantifiable hair count changes while maintaining strong tolerability, the convenience of oral administration and the potential, which we think is very exciting to have, the only FDA-approved oral treatment for both male and female pattern hair loss.

So okay. So walk us through what we got to see in the Phase II, in a little more detail.

Yes. So there are 2 co-primary endpoints. And I think importantly, the co-primary endpoints in the Phase II study are the exact same co-primary endpoints in the Phase III study conducted in the exact same way and a markedly population. And those co-primary endpoints are a target area hair count and a patient-reported outcome. And I know most people aren't familiar with these hair count -- with these endpoints. A target area hair count essentially asks how many hairs are there in a given square centimeter that are greater than 30 microns in diameter or a non-vellus hair? And you go, well, how does one measure that? It's a very laborious process, right? We tattoo the scalp, so we know where we're measuring. We clip the hairs so we can visualize all the hairs. We take standardized closeup photographs that go to a vendor that has done every approval in this indication back to 1997. They have a validated digital image analysis algorithm. That algorithm does 3 things. It lines up these photos, right, because in the same way you got a thumbprint, you got a hair print. It counts the hairs and it measures their diameters and ultimately, humans verify that. And we get this hair count. We then have the patient-reported outcome as well, which is the patient's evaluation of their coverage change. And what we saw is that as early as month 2, we had meaningful hair count changes that were out of proportion to what's been observed at peak in prior clinical studies. And by month 4, we saw further improvement beyond that, and that translated into clinically meaningful benefit on that PRO as well.

So maybe just, I guess, back up to what we were just talking about, which is how this is differentiated from IR minoxidil, talk about like, okay, it's an extended release, but here's what the PK looks like and the result.

Yes. So from a clinical pharmacology perspective, our premise is that we are able to deliver more minoxidil or greater exposures of minoxidil for a greater duration of time while blunting those peak spikes that are what drive the cardiac effects of the drug with the idea that those greater exposures for a greater duration of the follicle drive hair growth and then blunting the peaks can minimize cardiac risk. And so we see essentially the ability to deliver 2x more drug for 2x longer than what is delivered with a 2.5 milligram immediate release minoxidil tablet.

How do we know what that cardiac level is? Is it an established -- this is the answer, stay below it kind of thing?

Great question. So yes, this is not our threshold. This is FDA recognized in the summary basis of approval for topical minoxidil or Rogaine. And in essence, when Rogaine went over the counter, there was a question of, well, what is the safety threshold given it's absorbed systemically. And so the company at the time had taken 41 individuals with uncontrolled hypertension. Those are individuals that are known to be sensitive to the cardiac effects of minoxidil, and they gave them intravenous infusions of minoxidil. They sustained those infusions for 12 hours, and they did that at ascending doses until they saw the first sign of cardiac effects. So this wasn't a symptom or an adverse event. It was heart rate change greater than 5 beats per minute. That occurs at approximately 20 nanograms per ml. You stay below that, you reduce cardiac risk.

And then the other kind of, I guess, threshold, so to speak, is the -- if you're below this, you're probably not getting much hair growth. And if you're above it, you are. Help us understand how that was established and how your product works.

Yes. So originally, the way that was theorized is that there is oral or systemic data that ties Cmax concentrations of minoxidil to hair growth. And the minimal Cmax at which hair has seen is 1.62 nanograms per ml. So above that, you can grow hair. In our case, we're able to maintain fairly sustained exposures above that threshold while staying below the cardiac threshold. And at the follicle, there's a key piece of nuance that many people miss, which is in addition to being able to give more for longer, we are able to drive the drug's bioactivation to its sulfate metabolite. And I think a lot of people are not aware of this, but minoxidil has no effect on the follicle. It has to be sulfated to minoxidil sulfate, and that can occur -- that activation can occur in the outer route sheath of your hair. Now that enzyme is capacity-limited, meaning it can become saturated and time dependent, meaning it takes time to metabolize minoxidil. If you think to the pharmacokinetics of the immediate release drug, it spikes quickly, like saturating enzyme. It's not around for very long, giving insufficient time. Whereas with consistent and durable exposure of the follicle, you give more of a chance for the body to activate that drug and potentially get more hair growth.

So we've seen the pictures in Phase II, which you were describing. So we're getting twice as much basically hair growth in, I don't know, much less time. I don't remember exactly what was 4 months versus 2 months or 6 months or whatever it was. And that was in men. Have you done this in women as well?

Yes. So we have a Phase II study ongoing in women and a Phase III study ongoing in women. We started those studies after we had started the studies in men. I think from a scientific perspective, we feel very convicted that a minoxidil instant-release tablet has a lot of promise in females. The reason for that is that topical minoxidil and it's 2%, 5% and foam versions is approved in female pattern hair loss, which shows a treatment effect in females as the only approved molecule in females, right?

So your view is the men's study work and the women's studies should work.

Yes.

So no reason that men should work better than women. They both should work.

Yes. They should both work given the topical minoxidil was approved in both males and females.

Right, right. So the Phase III program, just let's make sure we understand the Phase III program. So you've got 2 in men that are ongoing, both are fully enrolled. You just talked about what the endpoints are. So the primary endpoint.

Exactly. So I think before we speak specifics on design, I think it's important what gives us conviction that Phase II data can translate in Phase III, right? Why should we feel good going into these studies. And I think there are really 3 reasons. First and foremost, as mentioned, the endpoints that we're studying in Phase III are the exact same endpoints conducted in the way in a markedly similar population to Phase II. The second is that minoxidil is fundamentally validated biology. It has been studied in numerous Phase III trials for topical, 2% topical, 5%, the foam. It's always beaten placebo decidedly. And the third, is that we have a deep understanding of this clinical space. We're a very obsessive group from a ClinOps perspective. So as we scale this from a smaller number of sites to a larger number of sites, we're very in tune with that. In terms of the studies themselves, each of these has approximately 500 subjects. They have 6 months to the primary endpoint. We talked about what those endpoints are. And ultimately, looking to be placebo. I think many people say, well, what does success look like in Phase III? How will we judge that this...

That was my next question.

Yes. It's like I'm a mind reader. But in terms of judging success, we judge success based on commercial viability. And the way in which we determine what is a commercially viable profile is based on what we tested in our quant work. As you may recall, we had surveyed 410 patients and 150 HCPs and the profile that we showed them is an FDA-approved, rigorously studied product that is orally administered minoxidil extended release tablet with an efficacy profile that is essentially on par with Rogaine, topical minoxidil, with a safety profile that's devoided treatment-related SAEs. And really, the response was remarkable. 99% of the HCPs said they were willing to use in some capacity, more than 70% very likely, but the 1% who wouldn't was because they wanted to see more data. And so there was a lot of enthusiasm about that profile. I think people go, well, why? For the patients, it's very clear that today, prescription treatment is a last resort. They don't feel like it's meant for them, right? Off-label use, it doesn't feel intentional, it doesn't feel like wellness or self-care. A prescription drug that is specifically studied for them, characterized for them does. And having the first approval in females and particularly would deliver that type of outcome. In the HCPs, right, today, and I think you heard this in your webinar, when you have to say to someone, Hey, I'm doing off-label -- is off-label use, it's a blood pressure medication and that creates friction. When you say, hey, this drug might give you erectile dysfunction, that creates friction. Whereas if there is an approved drug that's been studied in the indication, the talk track is much simpler. The visit is much simpler and docs like that.

Yes. So let's talk through some of the pushbacks that I hear and you can kind of respond to them. First one is, how do you expect everyone to pay $100 a month versus $20 a month for the IR today? Do you feel like your drug is 5x better, and you know any worth the money or something like that's one pushback. So what's the kind of...

This is one of my favorite questions, and I'm glad you're asking this question that I think that you got to hear this front and center in the webinar from the KOLs. This market requires a different thought process than, let's say, if we were judging oncology agents and that this is a consumer-directed market. And as a dermatologist, I can tell you, those derms did. These are motivated patients, right? When you see a hair loss patient, they come in and they say, I'm really worried about my hair. I'm losing my hair. I don't want to lose any more hair. Here's what I found on the Internet. What do I do? I don't think any derm has ever been asked, what's the cheapest option to treat my hair loss. That's not the psychology of this consumer-directed market. And similarly, for the prescriber, they're looking for something that they can have conviction around that's characterized that has actually been studied that they can have an easier conversation around. And we win on both of those elements. So to us, I think that's a no-brainer. And if you go out and talk to docs, which I spend about 20% of my time doing, I think it's a no-brainer.

So another would be, while the Phase II was open label, we saw pictures and stuff, but how do we feel comfortable, okay, it's going to work in Phase III. These are retrospective analysis -- that whole...

Oh, yes, all of that. So I think 2 points there. One is that we have an objective quantifiable endpoint in these studies. So the hair count, right, is objective in nature. It's done by people who are blinded to study blinded to treatment. And ultimately, in oral studies historically, placebo has gone down, right? People's hair growth only goes one direction, and that's that they lose more hair. From a photographic perspective, importantly, there are 2 things. So one, if there was ever a condition that lended itself to open-label study, it's hair loss because, again, people only worsen with time. You don't see people spontaneously regrow their hair that have pattern hair loss. And then two, we subsequently conducted an expert blinded grader review or something we call them a panel review where people were blinded to baseline, right? So they saw before and after photos, they're blinded to the baseline and they're blinded to the treatment and then they graded those identified baseline. And essentially nearly 100% of our patients, and this was presented at the EADV, they were able to identify the baseline because there's a visible difference between the photos.

Women don't want to use the product because they'll be afraid of hair growth in places they don't want it to grow. How do you view that?

So I think that, a couple of things there. One, right, minoxidil as a class effect definitely can result in unwanted hair growth, right? It's seen with Rogaine and we have greater systemic exposures than Rogaine. With that in mind, that hair growth is mild and manageable in nature. And so as a result, if you speak to derms, the mantra is very clear. And that mantra is it's much easier to remove unwanted hair growth than it is to grow new scalp hair. In fact, there's an article in the New York Times recently that said that 75% of American women removed unwanted hair growth within the last year. And so I think people imagine that we're going to turn the female population and having a nice beard like me, that's certainly not the type of hair growth that you see off target with this drug. And so while it is a potential tolerability issue, it is a mild one.

How do you have IP on this product because this is an old drug?

Yes. So this is an area that we spend a lot of time, and I think it's one of the great strengths of the program. In essence, the company aims to generate 100-plus Orange Book listable patents across 3 core pillars of intellectual property, the formulation, it's manufacturing, methods of use and clinical data and then pharmacokinetics release and dissolution. And we've done a lot of filing as we've disclosed. Ultimately, I think one of the key nuances here many people miss is that normally when you think about an extended-release product, it was a drug that was 3 times a day or 4 times a day and someone made it once a day in a bioequivalent formulation that is meant to be convenient. Now the problem with doing that is that because it's bioequivalent to an existing product, that means that the pharmacokinetics, for example, are inherent, right? They're in the prior art, they're not patentable. In this case, that's not at all what we're doing. We are taking a once-daily drug, and we have modulated its pharmacokinetics to achieve a different pharmacodynamic profile specific to hair and the pharmacokinetics of this drug are not inherent to any existing tablet. And so it is an incredibly novel, incredibly protectable type idea.

Yes. This is not a pushback, but more of just a question. What about competition, any? What else is out there?

So from an oral perspective, and we think that the oral route of administration is really the supreme route of administration. It's what patients are looking for. There are no clinical stage programs in the United States. What we see primarily are topicals and topicals are really challenging in hair. As we see with Rogaine, which has almost a 90% discontinuation rate, very few people understandably want to put something messy and cumbersome on their scalp twice a day for the rest of their lives. And even if they do, drug delivery right to the follicle with the topical is challenging. And so we see that as being a challenging area to work. I think there are other things that are earlier stage. And fundamentally, there have been no major scientific breakthroughs in understanding the biology of hair loss that would herald some sort of breakthrough at this point in time, unlike what we saw in alopecia areata, where GWAS studies identified the JAK-STAT pathway as being a critical underpinning. Now we have JAK inhibitors, and they work tremendously well.

Anything in like the injectable world that's been interesting to you as a physician?

Yes. So 2 types of injectables, right? There's intralesional injectables where people inject into the scalp itself. That involves a visit in the office that can be painful. I think some people are needle averse. And we look at PRP as being something that exists today. And that's a relatively small market realistically and from a commercial perspective, requires significant training. Most importantly, though, it's a different market than the market we're talking about, potentially complementary and not something that is necessarily direct competitive in that landscape. And then there's the monoclonal antibody type that is early in development. I think realistically, similarly, you're talking about a different segment of the population. And for a product at that price point to be compelling, the TPP of what's actually shown in the clinic needs to be rather compelling.

Yes., yes. Let's pivot to a conversation about the market, the number of patients out there, how you dissect them into different groups and kind of attack it from a marketing perspective. So pivot to the marketing strategy. It's kind of a all-in question.

Yes. So this is the single most prevalent chronic dermatologic condition, 80 million people that makes it 10x more prevalent than psoriasis, 2x more prevalent than psoriasis and atopic dermatitis combined. Now when we think about this market, it is certainly not a monolith. And we break it down by the treatments that people are using today. And there are about 15 million people actively treating. Within that, it's about 1 million people on prescription drugs, about 1.5 million to 2 million people on a supplement called Nutrofol, 4 million to 5 million people on Rogaine and the people on other various lotions and potions. Now in terms of how do you attack this market and what is the willingness from them, right? I think in order of adoption curve, you think people being on prescription drugs today already have a physician, they're at your highest likelihood of early switch, followed by OTC, followed by nontreaters. Importantly, when we did quantitative work, each of these segments has receptivity. And I think one of the things that was most important was that more than 60% of patients that are not actively treating their hair loss are open to talking to their doctor about [ BDPHL ]. And that's big because it's a 65 million person market right there. Now in terms of how do you get to these patients, there are 3 core pillars to our commercial strategy, right, essentially: physician adoption, patient adoption and then having a distribution network that is patient-centric. From a physician perspective, this is a dermatology-focused sales force type of product. And that when we look at prescribing data, 70% of this -- of these prescriptions are written by 11,000 physicians so that 100 to 150 type sales force is able to service that type of market.

Are there primary care in there too? Maybe pinpointed to a big writer so you can go after them as well?

They are high-volume primary care, and that raises a really important point in high-volume nurse practitioners and PAs that work within dermatology offices. One thing that makes adoption, like if you think about physician work streams different in this space than maybe if we had a psoriasis injectable is here, there's no complex prior authorization process, which is often a barrier to a primary care or someone writing. In this case, right, if you see an ad and you go, man, I want more hair. I'm going to call my primary care, there's really no barrier to them writing this drug. And so this is an area where things like nonpersonal promotion like your Medscape type has an ability to have an outsized impact versus an indication where the burden on the physician is really great and requires it really to be a specialist to write the drug.

So that's the derm. So the plan is to put some feet on the ground and bang on some doors of the dermatologist. And as a derm, your view is the derms are going to be receptive to this. They're going to be excited about this.

Absolutely. So I spend, again, about 20% of my time speaking to dermatologists. We spend a lot of time with the dermatologists, and there's a lot of enthusiasm. And I think I always say even to people who are on the lower end of enthusiasm, they say, well, of course, we'll end up using this because there's not a lot of options and our patients are going to ask us about it. And so I think, again, lots of enthusiasm to have an option within the hair loss space. For patients, we have a lot of experience as a company already with kind of direct-to-patient advertising in the form of our clinical trial recruitment. As I think you know, more than 100,000 people have submitted an online screener to try and participate in one of our trials from digital advertisements because just so much demand in this space.

100,000?

100,000. 100,000 people, it's massive. It's 1/3 of the population of Iceland. It's a lot of people. And I think then we think about being where the patients need to be, and that's something that I think is very critical, and that includes the traditional distribution type channels as well as the emerging or we like to call them emerged at this point channels, things like telehealth.

Right. So talk a little bit more, how does that work?

About how does telehealth work?

Yes, and what you're thinking right now and what the options are?

Yes. So I think from a telehealth perspective, what's in it for us is something everyone, I think, intuitively understands, which is there's a bucket of patients who aren't seeing a dermatologist currently that you could access in a rather high velocity manner. I think the question or the better question is what's in it for the telehealth provider? And I think the answer there is very straightforward. The challenge with selling generic drugs on the Internet, which is the state of telehealth hair loss today, is that there is nothing to keep someone else from selling a generic drug on the Internet. And so we've seen 2 economic dynamics. One, there has been downward price pressure, right, a race to the bottom on price. And then two, there's simultaneously been an increase in customer acquisition costs because there's multiple places you can shop. And so it squeezes in both directions, whereas if you can have a mass premium type product like this, then that is the ability to be really a tremendous winner for these individuals. And how do you know that to be true? Well, if you watch the Super Bowl, which I imagine you did, you probably saw an ad advertising the Novo products. If you are on the Metro North in New York, you probably see that many of the cars have, well, ads for Novo, if you have Hulu with ads, but this is a big area of really a lot of interest by virtue that with these products that can have, again, a mass premium type pricing, there is an ability to make the much more attractive.

So how many are out there that we know of?

How many telehealth players?

Yes, these direct players. I mean we know Hims & Hers and Ro, but how many others are there?

Those are the 2 dominant players. I think that the other people that you see like from the GLP-1s, they're on like LifeMD and there are several others. I think ultimately, to us, that's sort of a commodity type business. And so for us, the ability to reach patients is the critical element, not necessarily the specific provider.

Would you start your own, Veradermics Direct?

I think at this point, right, no specific plans related to...

It's a scenario. It's possible. So you could start your own. You could go to Hims & Hers, you could go to Ro. I guess you could go to one of the GLP-1s and just say, hey, we'll we write next to you? Sell to, right? I mean that's -- and so what will be the economics? How do we think about that?

Yes. So I think the way to think about it is, one, there's a different bucket of patients that you're not accessing otherwise, right? The Venn diagram of people who go to the doctor versus people who go get drugs on the Internet are different buckets of people. But two, really, the economics here that there is an arbitrage between the cost at which one of these direct-to-consumer players is able to sell a drug and the price at which the pharmaceutical company is able to sell the drug with the direct-to-consumer player having a lower customer acquisition cost because they have different regulations around advertising and because they have vertical integration through their system, allowing for better targeting and that they make money in that arbitrage.

Okay? So what would be the margin? What would be an example? Do you have any idea like what...

Yes. So I think we're not disclosing like a specific breakdown of how that works at this point. But I think as you see with large pharma clearly having a large channel there, the economics are viable.

So how do you convince Hims & Hers or Ro to sell your product when they're also selling like oral minoxidil, which they have -- I don't know if they -- I hadn't really looked, I probably should, but they brand it, they call it the Hims & Hers hair growth product or whatever they call it, right?

Yes. So I think this goes back to that concept that, right, it's tough to make a living selling generic drugs on the Internet because there's always someone who will sell it for cheaper and that your customer acquisition cost goes up. And importantly, right, as your revenue per user drops, the amount you can advertise to acquire those users simultaneously is going to drop. And so it impacts your ability to scale these types of units. So clearly, having a premium product. Importantly, when we have a differentiated product like this product that in and of itself drives demand, right? We anticipate there will be substantial enthusiasm around the product, that in and of itself, right, either you have our product or the train runs over you, right, then someone else will. And so I think that, that is a big reality. And when you think about these players, there's hair loss, but they have other verticals as well. And so their goal is to attract customers so that they can sell you your hair loss...

This one can bring them in and they could buy some other.

Right. We have the differentiated product in space so we can draw on you.

So is it possible that you could do it? Possible -- it's an interesting question. Is it possible that you could do a deal with Hims & Hers where they said, "You know what, we won't sell any minoxidil anymore. We'll just do an exclusive with you. But by doing an exclusive, we get a little better economics because we're giving up this other stuff. Is that even a possibility or...

I don't think we've discussed specifics of structures and what these things with different players could look like. Again, this is an emerging channel where each of these players has a different set of specific [indiscernible] approaches.

Right. But I mean, obviously, your product will incentivize them to want to play. So I guess it's possible that...

It's always.

They could replace it or they could just sell it right alongside and just say, hey, this is the best new thing.

I mean I think fundamentally, the great thing about if you can deliver differentiated product is that a differentiated product in the largest dermatologic market drives demand. It's a market, as mentioned, where people are motivated, they're motivated by branded products and that they are likely to seek out, right, the product.

Yes. Just one of those other debates that I keep hearing has to do with the idea of, well, we have to incentivize. Veradermics has to incentivize one of these systems to use the product because otherwise, if they're making more money off the IR, why...

Yes, I think that's a misunderstanding of economics, and I think a misunderstanding of generic pricing pressure. And similarly, again, a misunderstanding of the motivation of the patients in this market, and this goes back to the comment on price. The patients here are so motivated. They're frustrated, they're motivated, and we are trying to deliver them a product that actually aligns with the needs that matters for them, and that is the incentive.

Yes. Is this product potentially going to ever leave the United States and go elsewhere? Like what's the plan there?

Yes. So hair loss is a global problem. I think in South Korea, they said that this is a national emergency. And I had the privilege of getting to know dermatologists in Europe, dermatologists in Brazil, dermatologists all over the world. And there is clearly a need for hair loss treatment everywhere, and there's willingness to pay among consumers everywhere. And so while we've not disclosed a specific global strategy at this point, what I can tell you is that, right, the prevalence of this condition is relatively conserved across populations. The cultural significance of this condition is relatively conserved and that outside the U.S., the availability of a generic or minoxidil type product is reduced and in some place, absent completely.

Are you even available these direct systems? Like if I was living in Italy, could I go to Hims and Hers and...

So I don't know the specifics about Italy. I think it's very dependent on what jurisdiction you're in is available to.

But I mean you would need a drug approved in Italy to be able to access.

For us to sell a drug in Italy?

Yes. So if oral minoxidil is being sold over there, that's -- someone's got to write a prescription, which means it's got to be approved in Italy to sell it in Italy.

Yes, yes. And so importantly, in Italy, for example, currently, they do not have the generic oral minoxidil immediate release like we do in the U.S.

I mean I'm just using Italy...

It's a good example. In the EU, there's a minimum access, if no access.

Right. So there is a case to be made here where it makes a lot of sense to take all this data, submit it to Europe, try to get it approved in Europe and then...

Again, this is a global problem. I mean there's, what, 7 billion people in the world. And of those, 3.5 billion of them are going to lose their hair in their lifetime.

Yes. So our time is kind of up, even though we're the last of the day, so we can go a little bit longer if we want. But I guess, is there anything that we missed? Is there anything you want to kind of say before we shut it down?

Yes. I think fundamentally, the reason to be excited here is that we are close to Phase III data, right? We're going to top line first Phase III study in the first half of this year for a drug that is based on validated biology in a market that is tremendously large, tremendously hungry for a new solution. And we are a group of people who spends a lot of time trying to understand the physicians and their patients to try and deliver that actually matters to them. I think that there is tremendous value to unlock with hair loss, and I think it's reasonable to think that hair loss could be the next weight loss.

Yes.

Do you hear that?

Hopefully. Thank you. Thanks for joining us. That was fun. Great to see you. Good luck with everything.