Conference Transcript - MANE 2026-06-03

Operator

Good afternoon and welcome to the Jeffreys Global Healthcare Conference in New York. My name is Addison Marshall with the Jeffreys Investment Banking Team and it is my great pleasure to introduce Reid Waldman, CEO and Mark Newman, Chief Commercial and Strategy Officer of Veridermics.

Reid Waldman, CEO

Thank you, Addison, and thank you everyone for coming and spending time with us. Obviously, you have many ways you can spend time while you're at the Jeffreys Conference and we are appreciative that you came in person rather than waited later and listened to the webcast. I think this is going to be a lot of fun today. For those of you I don't know, and I see a lot of new faces, I'm Reid Waldman, co-founder and CEO of Veridermix, board-certified dermatologist by background, and prior to founding the company, my focus was primarily in clinical research, so I've done 100 publications, wrote a textbook, been an investigator for numerous Phase II and Phase III trials, and Veridermix, as you all know, is an aesthetics and dermatology-focused company that is aiming to bring forward the first oral treatment for both male and female pattern hair loss, an 80-million-person market. market. Today our goal is really to talk about the market opportunity and that in the back of favorable study 302 data, it has given us the opportunity to dive much deeper into the market, into the assumptions we've made, into understanding what it takes for this to be a major product. And so today we will walk through some highlights of that study 302 data that inform what the profile looks like and then I'll hand it to Mark Newman to talk about how that plays into the commercial case, but Mark, do you want to introduce yourself before we hop in?

Mark Newman, Other

Yeah, good afternoon, everyone. My name is Mark Newman. I'm the Chief Commercial and Strategy Officer here at Veridermics. Just by way of background, 35 years in the industry, first 25 years with Bristol-Myers Squibb in a variety of executive sales and marketing roles. Went out to Amgen for four years, launched a new cardiovascular business unit out there, spent a couple years in the global commercialization group before heading to Intracellular Therapies, where I built out the commercial organization, Launch Cap Blyda, until we attracted the attention of J&J and were acquired by them in April of last year and have been on board here at Veridermics for about six months, so look forward to interacting with you.

Reid Waldman, CEO

Obviously, we have all our disclaimers about forward-looking statements, et cetera, that's available on our website. I'm sure you've all seen it previously. But today we're talking about pattern hair loss or androgenetic alopecia, right? A pattern hair loss transcends being aesthetic. It's deeply personal, it's deeply psychological, and it's essentially universal. It affects 80 million people in the U.S. That makes it ten times more prevalent than psoriasis, two times more prevalent than eczema and psoriasis combined. Obviously both of those conditions have heralded numerous blockbuster products over the past decades, a time period during which we've had no new approvals for pattern hair loss. And at Veridermix, our premise is very simple. We are taking Minoxidil, which is validated biology for hair, and that it's approved as a topical for both male and female pattern hair loss, and we are aiming to optimize it for oral administration. Now as you may know, Minoxidil is used off-label for the treatment of hair loss in its oral form, but in that oral form it's a blood pressure medication, and the way in which it performs in the body is exactly as you would expect for a drug that was designed to rapidly lower your blood pressure. It spikes very quickly in plasma, within two hours the majority is gone, within four hours almost all of it's gone. And those spikes drive the cardiac effects of the drug, not necessary for hair growth, and that they don't provide consistent and durable exposures at the follicle that drive hair growth. And so, again, we set out with this idea and really this question, why is the best drug in the dermatologist's toolkit a 40-year-old blood pressure medication that no one's revisited and aim to optimize it to maximize hair growth, minimize cardiac risk through an extended-release tablet that provides consistent and durable exposure of minoxidil throughout the day at the follicle. We currently are a late-stage company with three ongoing registration-directed trials, two in males, the first of which we top-lined in April and we'll review data from that trial today, the second of which fully enrolled in February for which we anticipate top-line data in the second half of the year. We also have the first-ever registration-directed trial for an oral treatment for female pattern hair loss that is actively enrolling, which we're very excited about. Now when we talk about study 302 data up front I think it's clear the data was spectacular. We achieved a high degree of statistical significance in both co-primary endpoints and all key secondary endpoints demonstrating that VDPHL has a best indication potential as the only treatment that is positioned to generate fast hair growth with consistent treatment effect in up to 86% of patients while maintaining a strong tolerability profile with placebo-like overall AE rates, placebo-like AE-related discontinuation rates, and the convenience of oral administration. Now, we're going to look at data again just briefly from study 302. For those of you who are not familiar with this study, study 302 is a registration-directed phase 2-3 study of approximately 500 male subjects aged 18 to 65 at 44 sites in the U.S. In this trial, All subjects were randomized to either receive once daily, twice daily, or placebo. After the six-month treatment period, which is the treatment period we're looking at, or the primary endpoint period, patients then rolled into an extension study that is ongoing. Now there are two co-primary endpoints in the study. The first is target area hair count. The second is a patient reported outcome. Target area hair count essentially asks the question, how many hairs greater than 30 microns, what we call non-bellus hairs, are in a given square centimeter? We measure that in a very rigorous manner. We tattoo one scalp so that we know where we are. We clip the hair so we can visualize all the hairs. We take a close-up photograph. That photograph gets transmitted to a vendor that's done all approvals in the space in the U.S. since 1997. They have a validated digital image analysis algorithm that does three things. One it's going to line up the photo so we know we're in the exact same spot. Two it's going to measure the diameters of the hair because we only care about hairs greater than 30 microns. And then three it's going to count them. And we're looking at an absolute change in hair count from baseline, meaning that if someone started at 150 and they go to 180, then the absolute change is 30. And the reason we look at it that way is that that's how it's analyzed statistically. The second co-primary endpoint, as mentioned, is a patient-reported outcome. And the patient-reported outcome essentially asks the subject to look at their photo and evaluate their hair coverage change on a seven-point scale from much worsened to much improved. And if they're improved or much improved, they're considered to be a treatment responder. So what did we see in this study? non-vellous hair count, we saw a highly statistically significant benefit with about a 30 change in the QD group, about a 33 change in the BID group. Many of you may say I'm not familiar with non-vellous hair count. How does that compare to other treatments in the space? While this was not a head-to-head study and cross-trial comparisons have limitations, in general, we see versus other treatments like Rogaine 5% foam, off-label use of oral minoxidil, and Propecia, that there's about 150% to 300% treatment benefit. This then translated into clinically meaningful benefit reported by the patients with about half of all patients in the QD group, about two-thirds of all patients in the BID group reporting that they were improved or much improved in their hair coverage. Now, importantly, that's the outcome that we use for the regulator, but when we ask patients what matters to you, what is the outcome you're looking for, patients told us if we have any improvement, then that would be clinically meaningful. And as you can see here, almost eight out of ten patients in the once daily group, almost nine out of ten patients in the twice daily group report improvement. I will tell you as a dermatologist, if you ask me what is the piece of data that is just really remarkable, it's this, and that it has the potential to change the literal conversation that happens in the room. I spent so much time in practice telling patients our goal is to stabilize, stabilization is success, if you get extra hair, that's gravy on top. This data tells us that conversation could potentially change to say we think you're likely to grow more hair. The question is more how much. That is a major step forward. It's something we're extremely enthusiastic about. Now, importantly, it's not just the patients who thought they were better. The investigators also graded these photos. And here you can see a two or three point change on the Investigator Global that looks markedly similar to what we saw from the patients. When we look at any improvement on the Investigator Global, again, it looks similar to what the patients say. This is also very important clinically. So I want you all to put yourselves in my shoes. If you were a dermatologist, you're seeing a patient, how is this going to go? Well, you're going to say to the patient, how's your hair? In this case, 8 to 9 out of 10 of those patients, it's better. You're going to then look and say, how's the hair doing? And you're likely to concur. That is a recipe for treatment success and something that we're, again, very enthusiastic about. Now, importantly, I think people go, well, what does this look like? And, you know, today we're not going to look at a ton of photos, but we decided it would be good to look at the 50th percentile hair count responder on the frontal and the vertex scalp. And I think, as you can see, this is visibly noticeable hair regrowth for this individual, and it's something that I think is very exciting in as little as six months. Now I think everyone goes, well, what about the tolerability profile, and that, you know, obviously, you know, hair loss is not a life-threatening condition, even though it's very important to people, and tolerability here we were very, very happy with. We saw a placebo-like rate of overall AEs, a placebo-like rate of AE-related discontinuations, no treatment-related SAEs, no AESIs of cardiac origin, and for those of you who go, well, does that mean? It means no pericardial effusion, no pleural effusion, no heart failure, no angina, while seeing, and I'm trying to see what else is on our slide, and we saw no clinically significant differences in heart rate, blood pressure, or ECGs. I think that's very important because for those of you who have followed the story for a long time, the original design parameter around pharmacokinetics was the idea that if you blunted the C-max, then you could reduce right below a threshold where heart rate change occurs, and this, you know, is supportive there given that both the And then I think there was a surprise on safety, and most people hear surprise on safety and get nervous. In this case, it was a positive surprise, which is that we did not see hair shedding. And what we mean by that is after treatment initiation with minoxidil-based products, you typically expect to see an increase in hair shedding as hairs that are in the resting phase or telogen phase will exit. Here we didn't see that reported by patients. I think that was just an interesting point to note, and certainly we recognize for patients It can be really hard if you tell them you're going to get worse before you get better, so that was very exciting. In short, this substantiated a very exciting profile that Mark will then talk about how that tested with patients and physicians that demonstrates the potential for fast hair growth as early as two months, a consistent treatment effect with up to 86% of patients reporting improvement, an intense objective treatment effect with hair count changes that are out of proportion to what we've seen in prior studies, while maintaining strong tolerability profile and the convenience of oral administration and lining up for the potential for the first FDA approval for an oral treatment in male pattern hair loss in 30 years. I'll now hand it to Mark to talk about commercial.

Mark Newman, Other

Yeah, thanks, Reed. And note to self, always give the CEO the seat that has the clearest view of the monitor. Next time I'll get that one right. So as you can imagine, we are very excited about these phase three results. And with the results in hand now, we have undertaken a deeper assessment of the pattern hair loss market and also had the opportunity to take the emerging results from the clinical trial, the actual clinical trial results, put in front of physicians and patients, engage early reaction both in terms of the extent of differentiation they see for this product as well as their intent to prescribe. And so what this has allowed us to do is to refine the way in which we segment this market and our understanding of the market. And the headline on this slide is, of the 80 million people out there with pattern hair loss, 50 million men, 30 million women, there are about 20 million who are already either treating their pattern hair loss or they're demonstrating treatment-seeking digital behavior. And these are the 20 million patients that we'll target immediately upon launch, and these are the ones that we feel have the greatest potential for a rapid adoption of VDPH-L01. So I'll go through each of the three subsegments of these 20 million, because each is very important, and we've gained new insights from the research that we've done just recently. So if we look at the far left-hand side, the first subsegment I'd like to take a look at is those that are on prescription therapy. They're either on minoxidil, they're on finasteride, they're on some combination of the two, oral, injectable, et cetera. Consistently in the market research that we've done, this is the group of patients that will most rapidly adopt VDPH-L01. This number is actually quite a bit higher than where we thought it was, both because of the growth rate that we've seen in low-dose oral minoxidil, as well as some additional databases we've been able to identify that allows us to better estimate. And quite honestly, we believe that this box still might be underestimated because the prescription reporting services don't capture all of the cash pay telehealth scripts that come through as well. So that's a very important box, but represents 3 million of those 20 million patients. To the right of that, there's another 10 million patients who are currently treating their pattern hair loss with over-the-counter products. The two largest subsegments of this, 5 million Rogaine users, about 2 million Nutrafol users. And in a little bit I'll share some market research with you. For those patients, our ability to convert them from an OTC product to a prescription product, our conviction in being able to do that is getting higher and higher with the additional research that we do. And finally, there's a group of patients in the not currently treating but are showing digitally signaling high intent to seek treatment. And how do we identify those 7 million patients? We've worked with a consulting partner who has a collaboration with a company called V, which takes a look at the digital footprint of consumers and can reliably separate those consumers that are looking at, that are active treatment seekers in the marketplace versus those that are just passively looking at the space in which the treatment is. So they take a look at things like online purchasing behavior, Google searches, website visits, et cetera. And this has been validated with a number of other categories, including the GLP-1. So this box here in particular gives us a high degree of conviction that even those that are not currently treating their pattern hair loss, that we'll be able to activate those patients with our commercialization efforts. So in total, there's 20 million patients out there immediately at launch that we feel that will represent the most rapid uptake of VDPH-LO1. So the market today is really not serving patients well, and there are significant treatment limitations of the existing options that are out there. The market is characterized by a great deal of unmet need, And on the left-hand side, you can see here in the surveys that we do, only 9 percent of patients report satisfaction with the currently available options they have to treat their pattern hair loss, and nearly 50 percent of patients are actively seeking a new treatment. So this really speaks to the degree of unmet need that exists in the marketplace. And why is that? Those reasons are on the right-hand side. There are certainly efficacy reasons. So as Reed had spoken to in some of the data we saw that addresses this unmet need, there's a slow onset of hair growth with the existing products. Clinically significant results are often not seen for 4 to 12 months, and for patients this is just too long to wait. There's inconsistent results, so there's a great deal of intrapatient variability, and this can lead to treatment cycling from one therapy to the next therapy. And finally, there's insufficient density of hair growth, and this is results in patients being dissatisfied with the results that they see from the current treatments. But beyond the efficacy measures, there's also tolerability issues related to hormonal mood and cardiac side effects. There's inconvenient administration, either because they're cumbersome topical applications or they're multiple pills a day given in several doses. And finally, there are limited FDA-approved options out there. There are currently no FDA-approved oral options for women. So this creates a marketplace that is primed for disruption with an innovative prescription product. So as Reid said, when we got the top-line results for the Phase 2-3 study, our study 302, we were able to actually the weekend before take these actual results and put them in front of physicians and patients to gauge their early reaction to the profile. And I'd like to share some of those results with you here today. So this was a large quantitative and qualitative study of over 150 physicians and nearly 200 patients. These physicians are very much the physicians we would be targeting at launch. As you can see, they are high-volume treaters of pattern hair loss, over 250 patients on average a year. And the patients in this study are representative of the three segments that I spoke to before. So you have 60 percent of them who are currently treating their hair loss, either with a prescription product or with over-the-counter products, but another 40 percent in this survey that are not currently treating their hair loss. So what did we find? First of all, VDPHL is seen as highly differentiated by both physicians as well as by patients. So physicians, over 90% of them see VDPHL being positively differentiated versus the current treatment options, and patients, 95%. So on a seven-point scale, that means physicians rated it a five through seven, and patients did the same. If you took an even more stringent measure of the top two box of this, nearly two-thirds of physicians and over two-thirds of patients say this is either very or extremely differentiated from the products they currently have to choose from. in the marketplace. And this perceived differentiation on the part of physicians and patients translates into a strong intent to adopt VDPHL-01 seen across both physicians as well as patients. So for physicians, nearly three-quarters of them are highly likely to prescribe VDPHL-01 as evidenced by a top two box, very or extremely likely to adopt this product, and in terms of magnitude of their adoption, over 50 percent of their patients in their practice would receive VDPH-L01. Now, I've been doing these market surveys for an awful long time, and this is an extremely high magnitude of prescribing. Typically in these studies, even with clear differentiation, you typically see about a 20 or 30 percent allocation to the new product. So to see physicians state that they would put 50 percent of their patients on a product like this is really extraordinary. And the same is true on the patient side. So nearly three-quarters of patients are highly likely to talk to their doctor about VDPHL01. And remember, this is an aggregate number, so this includes the 40 percent of patients who are currently not even treating their hair loss who would be likely to talk to their physician about VDPHL01. And on this next slide, what we see is that both, again, physicians on the left, patients on the right report consistent intent to act across the treatment subgroups that I referenced in the first market segmentation slide that I was going through. So on the left-hand slide, regardless of whether a patient is on prescription therapy like minoxidil or finasteride, or they're currently treating their hair loss with an OTC product like Rogaine or Nutrafol, or they're not treating their hair loss at all, physicians see putting anywhere from 50% to 60% of their patients on VDPHL01, and in particular, that bottom line, that not currently treating, what this suggests is that they're very much viewing VDPHL01 as a potential first-line therapy for treating pattern hair loss. And on the right-hand side of the slide, in terms of the percent of patients who would talk to their doctor, the vast majority of patients who are currently on prescription therapy would talk to their doctor about VDPH-L01. Three-quarters of those taking an OTC product would talk to their physicians. And over half the patients who are not currently treating, based on their view of this product profile and the differentiation that it provides, they would be talking to their doctor as well. And the last data slide I have to show you is your typical sort of share allocation pre- and post-exposure to the new data. So on the left-hand side, this is what the physicians in the study, how they're currently treating their patients. So almost a third of the physicians in this survey had their patients on off-label low-dose oral minoxidil at about 30 percent. About a quarter of them were treating them with oral finasteride. Another quarter of them were on Rogaine, and then the remainder were on a variety of prescription or OTC products. After exposure to the actual data from the study 302, on the right-hand side, you see what their new allocations would be. So clearly VDPH-L01 becomes their go-to hair loss product at approximately a 50 percent share. And where would that share come from? It would come across the board. They would reduce their IR minoxidil use by half. They would reduce their finasteride use by half. And even with topical minoxidil, Rogaine, they would significantly decrease their use there, and this would all be in favor of VDPHL01. So that's the results of the study where we put the actual results of the study in front of physicians and patients, but we also, beyond our own market research, look at analogs in the marketplace and the ability to take a category that has emotional resonance to it, high prevalence indication, and with the introduction of an innovative new prescription product, the ability to see explosive growth in that category. So the most recent example of this is obviously with the GLP-1s and what those products have done in the obesity category with ZepBound and Magovi. They've grown the prescription weight loss market 16 times in recent years. But even looking at one of the original products that had a great deal of success in this, Viagra, grew the ED market seven times within the first month of launch. And the pattern hair loss market shares a number of these important dynamics with those two products and others that we think is instructive in looking at the potential of taking a market that's largely an OTC-dominated market, introducing new innovation with a new prescription product and being able to see explosive growth in the category. Those things like high prevalence conditions, you see the number of patients with pattern hair loss, 80 million in the U.S. alone. The fact that prescription treatments have not had any new innovation in this category for 30 years, very similar in the obesity category and in ED. There is a significant latent demand due to the lack of compelling treatment options that result in these categories really being OTC dominated until an innovative new prescription product is introduced into the market and those patients get converted over. And the other thing that is shared with the obesity and the ED analogs is the easily facilitated patient-centric access. We believe certainly that this will be a cash pay audience. It will be consumer-directed and shares a lot of the same characteristics as both the ED and the obesity market. So this gives us additional conviction in our ability to take this market and produce explosive growth. That's also instructive for how we'll go to market with VDPH-L01, and we believe that the clinical profile that's emerging from the clinical trials paired with a comprehensive commercialization effort will allow us to drive both explosive market growth but also capture market share within the category. So the compelling profile, you've seen the potential to have improved efficacy, improved safety and tolerability in a convenient oral form combined with a comprehensive commercialization go-to-market model that will include comprehensive HCP promotion, digitally-enabled patient acquisition and a patient-first channel and distribution strategy that reduces friction in the system, we believe is going to drive market growth, so more patients will be treated, more patients will come off the sidelines, as it were, because of the existence of VDPH-L01. The percentage of those patients that will be treated with an RX therapy will grow significantly, favoring VDPH-L01. But as you saw in the results of our clinical trials, we'll also be capturing share from the existing treatments. Both of these will drive the growth of VDPH-L01. So I think in summary, we see pattern hair loss as a large, untapped market that is primed for innovation and disruption with a product like VDPH-L01. There are over 20 million patients that we see as priority market segments at launch, another 60 million with the potential for activation. VDPHL, as you saw, is seen as highly positively differentiated from the existing treatments that are out there on the market today and has the potential to drive both market growth as well as capture share. And the analog markets that we take a look at also support the opportunity that we see in the marketplace. So with that, I will turn it back to Reid for a couple last comments, and I think we'll open it up for any questions that you might have.

Reid Waldman, CEO

Yeah, absolutely. And I think that everyone's question at this point is obviously We put out data that we believe to be spectacular. The first half of the year has been really a great year for us. What is coming in the second half of the year, right? What is there to look forward to at Veridermix? And I think there are a couple of things. On the male side of the house, right, we have a second confirmatory study that is a markedly identical study to the first study, you know, for which we believe that study 302 served as a highly de-risking event. We also have long-term extension data out of that first male study that will give us a sense as to how a treatment effect looks over time. We also recently have announced that in the second half of this year there will be additional female data, really the first female data that the company has released from a proof of concept study. And I think that there are really two critical messages that we want to get across on females today. One, we believe the female market opportunity to be a large additive opportunity that includes 30 million motivated females who currently make up the majority of hair loss treatment spending and for whom there are no FDA approvals of oral agents, there are no FDA approved prescription agents, and for whom we are positioned to disrupt that market potentially through the development, through the approval potentially of the first ever oral treatment for female pattern hair loss. The second item here is that we believe the female readout to be a high probability readout. And the reason we say that is that minoxidil has been demonstrated to be effective for the treatment of female pattern hair loss in its topical form. It's approved as a 2% solution, it's approved as a 5% solution, it's approved as a 5% foam. And the exposures that we generate in the female population in study 207 and study 306 are similar to those that we showed to be effective in study 302. And I think realistically if you asked us, what are people, you know, not getting right on the story right now, or where are people not put adequate attention? It's the female opportunity. And in my clinical practice, when I think about all of the conditions we treated, all of the patients I saw, female pattern hair loss from an emotional perspective was at the top of the list. It is so impactful. There is a serious dearth of treatment options, and if we can deliver the first FDA-approved oral treatment for female pattern hair loss, I think it would be very, very exciting. So So thank you so much. I know we're like out of time. I don't know if we have time for one cell side question, but if not, feel free to come up in and ask us. But, Nabil, do you have any questions for us?

Operator

I see that exponential growth that you saw on the shield once entered, right?

Mark Newman, Other

Yeah, I think we've taken a conservative approach in identifying the seven million patients that have exhibited a very high intent. There are different levels of intent that the VE database tracks and takes a look at and has validated. That represents the highest of the high intent. Those are the ones that you can think about literally have been sitting on the sidelines waiting for something to come out that they feel is worth pursuing as a treatment option for them, and those are the ones that would be converted the most rapidly. That's not to say that the remaining of those 60 million that they won't be able to be activated. We think we will, but in terms of thinking about the initial launch, those 20 million patients, including those that are on prescription therapy, those that are on OTC, and the additional patients that are showing very high intent to seek treatment would be the initial target for us.

Operator

And then to do the hair part, and there's maybe less distance to show that?

Reid Waldman, CEO

Yeah, so I think you're getting an interesting concept is that, you know, when we look at historic data in females, and we look at it using the same methodology that we look at males, that on a relative basis, you know, the numbers on hair count are lower, and they're probably two reasons for that, as I think you're alluding to. One is that, on average, females lose less hair than their male counterparts, and so there's less hair to regrow. And then, two, as we think about, you know, where you place the tattoo, right, a hair count is only as good as the square centimeter that you measure. In the male population, there's a clear transition zone, given we see circumferential vertex balding. In females, there's not always that same level of enriched transition zone. I think, realistically, if you call dermatologists, you will hear very resoundingly that minoxidil works in females. And in every clinical study, right, for 2%, 5%, and 5% foam, you know, they've beaten placebo. So we have a lot of enthusiasm about female pattern hair loss. We have a lot of enthusiasm about that opportunity, and I think that that's an area where there is really an under-recognition of how impactful that is on the patients. I know we're out of time, and I want to be respectful of whoever is coming next, but thank you, everyone, for making the time to come and see us.