Veradermics, Incorporated ($MANE)

Good morning, ladies and gentlemen. Welcome to the Veradermics 302 Phase 2/3 Topline results conference call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Dominic Carrano, Chief Financial Officer of Veradermics. Please go ahead, sir.

Thank you, operator, and good morning, everyone. Thank you for joining us today to discuss Veradermic's positive top line results from the Phase 2/3 302 trial of VDPHL01 in patients with mild-to-moderate pattern hair loss. This morning's press release is available on the Investors section of our website where we will also post the slides used today following the conclusion of this call. Joining us on the call today are Dr. Reid Waldman, Chief Executive Officer; [ Mark Newman ], our Chief Commercial and Strategy Officer; and Veradermic's Scientific Advisory Board member, [ Dr. Mary Anne Sena ]. Dr. Sena is a leading hair loss expert, board-certified dermatologist at Best Israel AH Health and Assistant Professor of Dermatology at Harvard Medical School. She will provide clinical perspective later in the call. Dr. Waldman will begin with opening remarks and present the results from Part A of Study 302. We will then hear from Dr. Sena for our clinical perspective on the PHL treatment landscape and implications of the results presented today for both patients and their physicians. Mark will then provide commentary on the commercial opportunity around VDPHL01 and quantitative and qualitative research conducted with patients and physicians using the VDPHL01 profile demonstrated in today's results. We'll close the call with remarks from Reid read and then Q&A. Before we begin, I would like to remind everyone that today's discussion, including discussions during the question-and-answer portion, will contain forward-looking statements. Any statement that relates to expectations or predictions of future events, results or performance are forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Please refer to the forward-looking statements section in today's press release and our most recent SEC filings for a discussion of these risks. With that, I turn the call over to Dr. Reid Waldman.

Thank you, Dom, and good morning, everyone. I'm extremely excited to walk through the initial top line readout from 302, a randomized, double-blind, placebo-controlled Phase II/III study evaluating VDPHL01 in males with mild to moderate pattern hair loss. . Now upfront, let's be clear. We believe the data is spectacular. We achieved a high degree of statistical significance in both co-primary endpoints and all key secondary endpoints in both dose groups. And the magnitude, speed and consistency of care growth exceeds every metric we set forth for the base case. Furthermore, we observed a remarkable safety profile that was characterized by placebo-like overall AE rates. And so we believe these results indicate the potential for VDPHL01 as a possible best in indication treatment that could transform the treatment landscape if approved. And if approved, this would be the first FDA-approved oral treatment for pattern hair loss in nearly 30 years. Thank you again for joining us on what is truly an exciting day for Veradermics and what we believe is a truly exciting day for the 80 million people living with pattern hair loss in the United States. Now as you all know, pattern hair loss transcends being aesthetic. It's deeply personal. It's deeply psychological and it's essentially universal as it is the single most prevalent chronic dermatologic condition affecting approximately 80 million people in the U.S. That makes it 10x more prevalent than psoriasis, twice as prevalent as atopic dermatitis and psoriasis combined. Now both of those conditions have heralded nearly 2 dozen blockbuster drugs over the past 2 decades, that's a time period during which there have been no new prescription drugs for pattern hair loss. Now despite being so prevalent and having so little innovation, this is a market where patients are motivated. It are frustrated. In fact, only 9% of treatment-seeking patients report satisfaction with existing therapies. And really, this should come as no surprise as today's treatments are slow, they're inconsistent. They primarily deliver slight regrowth when they do work and they force patients to choose between side effects like erectile dysfunction and decreased [ leadout ] or messy topical application twice daily for the rest of their lives. Now as a result, many patients who are bothered by their hair loss sit on the sidelines of treatment. But with today's results, we're hoping to change that. As you all know, we are developing VDPHL01 as an oral nonhormonal treatment for both male and female pattern hair loss. And VDPHL01 is an oral minoxidil extended-release tablet. The premise is very straightforward. Minoxidil is validated biology for hair as it's approved in its topical format for both male and female pattern hair loss, and it also exists in oral immediate-release blood pressure medication that is prescribed off-label for the treatment of hair loss, now the problem with that blood pressure medication is that it does exactly what you would expect a drug that is intended to rapidly lower your blood pressure to do. It spikes quickly in the plasma. The majority has gone within 2 hours, almost all of it within 4 hours. And those spikes drive the cardiac effects of Minoxidil, but they're not required or conducive to hair growth as they don't provide consistent and durable exposures to Minoxidil at the follicle. Now we set out with the goal of optimizing minoxidil for oral administration, maximization of hair growth and minimization of cardiac risks via the development of an extended-release tablet that provides consistent and durable exposures of Minoxidil to the follicle throughout the day, while blunting those peak plasma concentrations that drive cardiac effects. The premise being more Minoxidil for longer will drive air growth and that wanting those peaks would minimize cardiac risk. And today's 302 trial readout supports our view that optimizing VDPHL01 PK profile can deliver a clinically differentiated profile of maximized hair growth with minimized cardiac risk. Now one key nuance to this profile that many people miss is that in addition to giving more monoxide for longer, we believe that we can maximize hair growth by driving the bio activation of Minoxidil to Minoxidil Sulfate. And I think many people are unaware of this, but Minoxidil itself has no effect on the hair follicle. It's sulfate metabolite Minoxidil Sulfate does. And Minoxidil can be activated to Minoxidil Sulfate in the outer [ reef sheet ] of the hair itself via the [ SALT 1A1 ] enzyme. Now that enzyme, like mini enzymes, is capacity limited, meaning it can saturate spikes in plasma concentrations and it's time dependent, meaning that it takes time to activate Minoxidil. Now when you think about the PK profile of the immediate release, right, that drug spikes quickly, overwhelming and saturating the capacity of the enzyme, and it crashes quickly, giving insufficient time for the enzyme to activate Minoxidil. Whereas with an extended release tablet, we can provide consistent and durable exposures that drive bio activation and potentially drive additional hair growth. Now before we dive deeper into the data, let's review the study design in more detail. Study 302 is a registration-directed Phase II/III trial that enrolled 519 male subjects across 44 sites in the United States. Today, we are sharing data from Part A, the 6-month placebo-controlled period for both the once-daily or QD and twice daily or BID dosage forms versus placebo. Now let's discuss these co-primary end points in detail. And as a reminder, we achieved a high degree of both statistical significance and clinical significant benefit on both. And we'll start with the co-primary endpoint of Target Area Hair Count or TAHC. This is a quantitative and objective metric that has been the gold standard for hair growth approval since 1997. This is a very specific endpoint that measures the number of hairs that are greater than 30 microns or [ non-Bellaire ] in a given square centimeter on the scalp. And the way in which we measure this is that we begin by tattooing a small area on the scalp to ensure we're measuring the exact same spot every single time. We then click the hairs that we can visualize every hair, including individuals that are curly haired and we take a high-resolution standardized photograph. That photograph has been transmitted to a vendor that has been involved in every single approval in the U.S. since 1997. They analyze the image using a validated digital image analysis algorithm that does three things: it aligns the image, it measures the hair with and then it counts the hairs, those accounts then undergo a two human independent quality assurance review. Our second co-primary endpoint is the patient-reported outcome or subject evaluation of hair coverage change on the Androgenetic Alopecia Impact Rating Scale or AAIRS. In this instrument, patients compare standardized photographs of their scalp at baseline to follow-up and they rate their hair coverage on a 7-point scale for much worsened to much improved. And this endpoint is a responder analysis where we're looking at the percentage of patients who rate themselves as improved or much improved. Now let's look at baseline characteristics. And as we begin, I want to call out a number of critical baseline characteristics that can impact the interpretation of both safety and efficacy data and that demonstrate that the study population is uniquely representative of the overall hair loss population. First and foremost, this is the oldest group of individuals that have participated in the Phase III trial for Pattern Hair Loss. We enrolled subjects up to age 65, whereas [ Propecia ] went to 41, [ Rogaine ] to 49. And when you look a little closer, roughly 60% of subjects are over the age of 40. That's important for two reasons. First, when you think from an efficacy perspective, each decade of life, people become less responsive to hair growth treatments. Second, each decade of life, people become more likely to experience adverse events. So this gives us a more representative population from both a safety and efficacy perspective. Furthermore, this is an ethnically diverse population that generally mirrors the demographics of the overall U.S. population. From a severity perspective, we see severity of hair loss right down the [ Norwood Hamilton ] scale that is similar to prior studies. That means that roughly half of our patients are classified as [ Norwood Hamilton 3Vs, meaning they have some [ Vertex ] balding while about 1/4 of 4s and 1/4 of 5s, respectively. Mean baseline hair counts were approximately 150 and which demonstrates appropriate selection of target areas within the transition zone. And then finally, we did not cherry pick this population for safety. The majority of subjects in the study have a cardiac risk factor, high blood pressure. And that's important not only because it's representative of the U.S. population. But in the context of a Minoxidil-specific study, hypotensive individuals are known to be more sensitive to the [ hemodynamic ] effects of Minoxidil, so it gives us a more representative look at safety. Now let's look at co-primary endpoint data, starting with the [ non-vellus ] hair count. With the [ non-vellus ] hair count as an objective, quantifiable endpoint that evaluates the absolute change in [ non-vellus ] hair count over baseline. That means that if someone's baseline hair count is 150, and it increases to 180, then the change is 30. And the reason that we present data this way is because that's how it's statistically analyzed as a co-primary endpoint. Now in the QD arm, we saw a hair count increase of 30.3% and in the BID arm an increase of 33%. And I think one of the big surprises of this data set is just how strong net once daily data walks. Now to put this data in context, this represents leading data on this endpoint. And while these are cross-trial comparisons with inherent limitations that are not based upon head-to-head studies, our data suggests a 150% to 300% greater benefit than oral Minoxidil 5 milligram, topical Minoxidil 5% foam and [ finasteride ] 1 milligram, and our data is ITT or intention to treat data, whereas other existing data is calculated either as last observation carry forward or as-observed data, which can artificially inflate the results of these comparator studies. Additionally, because there is no regulatory grade trial of off-label immediate-release oral Minoxidil for hair loss, the study shown here for oral Minoxidil are the only two prospective studies to use a digital image analysis algorithm to measure hair count. Now these objective improvements in hair count translated directly into hair growth that patients reported as being clinically meaningful to them. At month 6, nearly half of patients in the QD arm and nearly 2/3 of the patients in the BID arm rated themselves has improved or much improved on the AAIRS. And while regulators evaluate a 2-point or greater change I think what's more important is what the patients feel is meaningful to them. And in our in trial interviews, more than 80% of patients told us that any improvement would be clinically meaningful. And at month nearly 90% of patients in BID, nearly 80% of patients in QD reported improvement in their hair coverage. And this consistency is further supported by the Investigator Global Assessment, we're going to start by looking at patients who had moderate to great improvement on the [ IGA ] and it looks just like the data for patients who are improved or much improved on the PRO. Now we look at patients with any improvement on the and it looks just like patients that reported improvement on the PRO. And this is extremely important. And I want to put you all in my shoes as a dermatologist. In the real world, when a patient comes in for hair loss follow-up, the first thing that you would ask as a dermatologist is how is your hair doing. In this trial, nearly 8 out of 10 patients in the once-daily group nearly 9 out of 10 patients in the twice-daily group are going to report improvements in their air coverage the a doctor, I'm better. Now as a dermatologists are going to examine their hair and compare it to photos from their prior visit and based on the level of consistency that we saw between the IGA and the patient assessment almost every time the dermatologist and the patient are going to come to the same conclusion. And we believe that, that level of consistency and that level of alignment is a very important determinant of real-world adoption because when I think about my experience treating hair losses dermatologists one of the biggest limitations of treatments is that they're inconsistent, but it often felt like I was throwing darts in the dark. And today's data has the potential to be a strong breakaway from status quo, a strong breakaway from that experience and has the potential to get patients and physicians an option with very high rates of visible hair growth. So what does this hair growth actually look like? We're going to look through representative photos of patients at the 25th, 50th and 75th percentiles of response based on [ non-vellus ] hair count. And these are meant to be illustrative of the average type of response and a range of responses that we observed in the study. starting with the 25th percentile. Note that in both the Frontal and the Vertex scalp, we are seeing visible regrowth. And that funnel regrowth is especially important because no drugs today are FDA approved for the treatment of frontal hair loss. When we move to the 50th percentile, we see similarly strong regrowth on both the Frontal and the Vertex scalp and the 75th percentile, much of the same. And the criticality of business that it shows that there is a strong consistency of outcomes across the treatment spectrum as is consistent with what we saw on both the patient and investigator assessment of hair regrowth. Turning now to safety. We're extremely pleased with the tolerability in the study and that it's consistent with our goal of minimizing cardiac risk by blunting minoxidil peaks and the data is generally in line with what we saw in Phase II. Specifically, we saw no observed drug-related SAEs, no AESIs of cardiac origin, so no pericardial effusion, no perifusion no angina to heart failure. Furthermore, the overall rates of adverse events or placebo like. The overall rates of AE-related discontinuations were placebo-like and the AEs that did occur were primarily mild moderate in nature, often self-resolving and they were an uncommon cause of discontinuation as mentioned. Additionally, and I think this is very important. We saw no clinically meaningful changes in heart rate, blood pressure or ECGs. Interestingly, Participants in the study did not report an increase in hair shedding after treatment initiation and an increase in hair shedding or what's called the [ dredshed ], is extremely common with both topical and immediate release oral mono. In fact, at AED, we presented a poster demonstrating that the risk of shedding is the #1 concern of patients that discuss Minoxidil-based treatments online. And we're very pleased to report we didn't see that in our study. This slide again highlights the safety profile, showing placebo-like overall AE rates, a placebo-like rate of AE-related discontinuation and no treatment-related SAEs. The only events that occurred in more than 5% of patients with an imbalance between active and placebo or edema and hyperthecosis. Edema resulted in an extremely low discontinuation rate approaching 1%. And for hyperthecosis, there were 0 discontinuations. This supports that these are expected, as they've seen with [ Rogaine ], they're low grade and are generally well tolerated. Prior to the readout, we shared expectations to finding a commercially viable profile based on robust quantitative market research of 150 HCPs in 410 patients. And in this research, we saw a response from patients and their physicians that demonstrated that more than 70% of physicians were very likely to prescribe and that patients showed similar enthusiasm. The profile that we had tested was essentially an FDA-approved, rigorously studied and characterized oral minoxidil extend release tablet with an efficacy profile that is on par with [ Rogaine ] game 5% foam, meaning, as shown here, placebo-adjusted hair count rates of about 15, placebo-adjusted PR response of about 25% and while having a profile that was deployed of treatment-related SAEs and with the convenience of oral administration. I think it goes without saying the trial is a clear beat of this commercially viable case. With us exceeding targets for [ non-velus ] hair count by meaningful margin, of PRO response by nearly 2x in the BID group, while maintaining that safety profile with no observed treatment-related SAEs in maintaining the convenience of an oral pill. In summary, we saw a profile on 302 that's given us conviction that VDPHL01 is positioned as a best in indication treatment for pattern hair loss, if approved. Specifically, we saw a profile that's fast, with superior aircraft to placebo as early as month 2, the earliest time point measured, that's consistent with nearly 90% of BID patients, nearly 80% of QD patients reporting improvement in their hair coverage. Its intense with non-vellus hair count increases, right? Objective changes that are out of proportion to what's been observed in prior modern trials in the space while seeing a strong tolerability profile with AE rates that are placebo-like with AE-related discontinuations that are placebo-like and having the convenience of oral administration. So to recap, PD-L1 was fast, consistent and generally well tolerated while maintaining the convenience of oral administration and having the potential to become the first ever FDA-approved oral treatment for both male and female pattern hair loss. Now I'd like to welcome to the call, Dr. Mary Ann Sena. Dr. Sena is a board-certified dermatologist and renowned alopecia expert who practices at the Lake Clinic in Massachusetts. Dr. Sena founded and directed the Mass General hair loss clinic as well as the Lake hair loss Center of Excellence. She's an Associate Professor of Dermatology at Harvard Medical School and has published over 200 publications, most of which were on hair loss. She is a true authority on the topic. Dr. Sena, thank you for joining us today. We're hoping you can tell us a little more about current treatment options for hair loss, your thoughts on our data and how VDPHL01 might fit into your practice if approved.

Pleasure to be here, Reid. Thank you for inviting me. I think it's important first for clinical -- for context is to understand what my practice looks like. So I have been seeing primarily hair loss patients, 98% to 99% of my patient panel are seeing me for hair loss and I've been doing this for 15 years. I think unless you've lost your hair yourself, it's hard to appreciate just how impactful hair loss can be for people. It's so tied to our identity, our sort of considerations that we have youth and fitness and health that when people start to lose their hair, it literally goes into every aspect of their lives, right, how they do their job, how confident they feel how it impacts your relationships, how they present themselves to the world. And so it's not surprising that there's this huge demand for patients who want to treat their hair. They're waiting over a year to see someone like me. In the meantime, they've tried to over-the-counter things, supplements, et cetera, all of which really fall short of where they want to be for therapeutical. So when they come to see me, they're looking for something that's going to give them meaningful hair growth that's going to make them feel better, the more like themselves, and they want those results as quickly as possible. So current treatments fall short of patient expectations. And let's talk about what I mean by that. First of all, the last time we had an FDA-approved medication for men with hair loss was 30 years ago, 30 years ago. And for women, the only FDA-approved medication that we have is topical Minoxidil. patients hate topical medications, right? They hate having to rub something into their scalp every day. There are practical issues like, how am I saddling my here, it's gunking up my hair. It's not something that patients are going to want to stay compliant with day after day, year after year, I hear this all the time. So patients are coming in and they're opting for something that's oral medication that's easier to stay compliant with in the long term. And when we start to review their oral options, again, we're falling really short of where patients want to be. So if we think about [ Propecia ] or [ finasteride ] for example, there's 1 dose that's given that's available. And with that dose, we see clinical efficacy and patient satisfaction in my clinical practice that falls significantly short of where patients want to be. They're just not getting the hair regrowth that they want. In addition, patients are understandably concerned that this is a hormonal medication that it could potentially lead to sexual side effects and other side effects on mood and energy levels that not only make it impossible to push the dose but make patients sort of want to increasingly shy away from this as an option as well. When immediate-release Minoxidil came on the market, I was like, this is great. It's not hormonal. It gives me another option to offer these patients. I was really excited. I thought great. We have something else to give them as a treatment. And initially, we were seeing some hairy growth, but very quickly, I saw that patients were plateauing, right? They were getting a little bit more hair growth, still not where they want it to be as therapeutic goal still not satisfied with how they were doing. And when we tried to push the dose further we ended up seeing increasingly emerging side effects that made it intolerable for patients. But more importantly, with incremental increases in dose, we were seeing increases in hair density and meaningful improvements for patients, which makes sense because the wave immediate release Minoxidil is sort of made it doesn't hang around the hair halt long enough to make significant here growth happened even on higher doses. This huge gap still remains where we aren't able to offer patients treatments to get them to where they want to be. So now I'm really excited about this data and what it will mean for our clinical practice. So let's review specifically what I mean by that. First and foremost, this was a really well-designed trial, right? Not all treatments in this space have been studied in such a robust and like rigorous manner, right? So the first thing that stands out to me is the hair count. When we look at post-treatment hair counts, compared to other studies that I've seen and the treatments in this space, this far surpasses what we're seeing with other therapies. So that's huge. The second thing is that there's a very reassuring safety signal here, right, where there's no significant safety concerns that we're seeing coming out of the study, but many of which at baseline had cardiovascular risk factors. This is huge for dermatologists and non-dermatologists like for people who are going to be prescribing a medication like this. This is incredibly reassuring and makes us feel like we have something that has clinical efficacy while also a proven towards safety record. But probably the most exciting data out of this for me as someone who treats these patients all the time is the patient reported outcomes, right? The fact that 86% of patients came back and said, I've seen improvement. I feel like my hair is better. That's just like something I never hear in clinic, right? Patients will come back after 8 months or a year and still not really feel like they're improved, to see these sort of base report outcomes were 86 patients are saying, "I'm better" is enormous. And really that says to me, this is something that will be a no-brainer as a first-line therapy. In addition, patients are seeing these results as early as 2 months, right? So it addresses the most important things for me as a prescriber, one, clinical efficacy; two, safety; and three, patients are happy, right? We don't have something like that right now. So I'm really excited to be able to have this in what I'm able to offer patients. And I think very quickly, it's going to catch on as the first line treatment that people are looking to offer.

Thank you, Dr. Sena. At this point, I'd like to ask Mark Newman, our Chief Commercial and Strategy Officer, to discuss the commercial implications of this data.

Thanks, Reid, and good morning, everyone. As Reed mentioned, the clinical outcomes we observed in the 302 study reinforce our confidence in the product profile of VDPHL01. And we believe positions VDPHL01 to become a foundational oral treatment option and a new standard of care for patients with pattern hair loss, the largest aesthetics market in the world. Following receipt of the 302 study results, we feel that a market survey this weekend with both health care providers and patients to gauge early reactions to this top line data and to generate insights into product perception and usage intent. And I'm pleased to report that there was a very high degree of enthusiasm by both HCPs and patients for the results seen in Study 302. But before I share the details of the market research results, I'd like to remind you of the patient population segments that make up this market. As Reid mentioned earlier, there are approximately 80 million people in the U.S. alone with pattern hair loss, including 50 million men and 30 million women. It is a massive market. We estimate that there are approximately 6 million patients whose condition is of a severity that they will be unlikely to benefit from hair loss treatment, still leaving 74 million patients as the total addressable market. Of those 74 million, 15 million are currently actively treating their pattern hair loss without a prescription therapies, such as low-dose oral Minoxidil being used off-label or [ finasteride ] or they're treating their condition with over-the-counter products such as Rogaine, nutraceutical, shampoos or a variety of other OTC products. The remaining 59 million patients are not currently treating their pattern hair loss, either because they are treatment naive or they had previously tried but discontinued their treatment due to a lack of efficacy, tolerability or convenience. Simply put, they are not satisfied with the currently available treatment options. We believe in the market research results confirm that VDPHL01, if approved, has the potential to capture significant market share across all four of these addressable segments. We feel that this market research in a double-blinded manner, including both a quantitative survey and qualitative interviews. It was a large sample size with 153 HCPs and 190 male patient participants, including representation from each of the patient population segments on the previous slide. The physicians in our study see a high volume of patients with pattern hair loss, treating on average over 250 patients per year. Of that, about 56% are male and 44% are female. Now keep in mind that since our top line data in Study 302 are from the male population only, we focused our respondent on their male population. And the data we will walk through today is applicable to the male population. The patients in our study included approximately 60% that are actively treating their condition and another 40% who are not currently on treatment, and we had a good mix of ages, consistent with the population in Study 302. So let's get into the market survey results. As you can see on this first slide, greater than 90% of both HCPs and patients view VDPHL01 as being positively differentiated versus the currently available treatment options for pattern hair loss. And approximately 2/3 of both HCPs and patients rated VDPHL01 as either very or extremely positively differentiated. We take a closer look at the specific attributes that distinguish VDPHL01 from existing therapies. You can see that it is seen as highly differentiated based on FDA approval and a combination of strong efficacy and strong safety with greater than 70% of both HCPs and patients rating VDPHL01 as very or extremely differentiated on each of these attributes. And as you'll see on the next slide, this perception of clear differentiation translates into a strong intent to adopt VDPHL01 by both HCPs and patients. In this survey, 73% of HCPs indicated they would be either very or extremely likely to prescribe VDPHL01 once approved. And in terms of the magnitude of prescribing, they said that greater than half of the male patients in their practice with pattern hair loss would receive VDPHL01, suggesting significant market share capture. Patients were similarly enthusiastic with over 70% indicating that they would be highly likely to talk to their doctor about VDPHL01. And importantly, on the left-hand side of this next slide, we see that HCPs intend to prescribe VDPHL01 at a high level across all of the patient population segments discussed previously, including those patients who are currently on a prescription therapy with or without an OTC product at 52%, those who are currently only on an OTC product at 58% and nearly 50% of those who are not currently treating their pattern hair loss at all. And HCPs have a high degree of confidence in VDPHL01's ability to address the unmet needs in the market today of more FDA-approved treatments, greater overall efficacy and treatment options without hormonal or sexual side effects. And you can see on this next slide that patients across all of these same segments show a high intent to ask their doctor about VDPHL01 with a large majority of current prescription patients in more than half of currently untreated patients expecting to talk to their doctor about VDPHLO1. Their reasons for interest in VDPHL01 are very similar to what we saw in the previous slide for HCPs and include hair growth results, more FDA-approved treatments no hormonal or sexual side effects and greater overall efficacy. Now in terms of where VDPHL01 business will come from, we can see on this slide that it is expected to be sourced from all current therapies particularly from oral IR Minoxidil and [ finasteride ] whose market share would be reduced by half but also from Rogaine and other OTC products, which would decline significantly as well in favor of VDPHL01. Lastly, I'd just like to close by sharing the voice of the patients and HCPs from the qualitative interviews, which highlight the unique opportunity for VDPHLO1. As you look at some of these quotes here, you can sense the excitement and enthusiasm of both patients and HCPs for the potential of product with the clinical profile of VDPHL01 to address the limitations of the currently available options to treat pattern hair loss. We are deeply encouraged by these survey results, which reinforce our prior quantitative market research and now with actual clinical trial results where we see robust intent to prescribe and intend to use among both health care providers and patients. All of these data points continue to confirm that this product's differentiated profile meets or exceeds what physicians and patients have told us that they need to adopt the new oral therapy. So thank you for your time today, and I look forward to continuing to update you on our go-to-market commercialization plan and our launch readiness in the coming months. And with that, I'll turn it back to you, Reid.

Thank you, Mark. In conclusion, and I think this goes without saying, we're extremely excited about this data, which demonstrate the profile that we believe has the potential to be the best in indication treatment, if approved, specifically a profile that is fast, with visible results as early as 2 months that's consistent with an extremely high rate of patients responding to treatment that's intense with strong objective and measurable changes in hair count while maintaining good tolerability, the convenience of the oral administration and the potential to become the first FDA-approved oral treatment for both males and females with pattern hair loss. And as we think about the potential significance of this data, I want to take a moment to step back and tie this data to the experiences of the actual patients in this trial in their own words. Now here, you can see several patient quotes from the in-trial interviews, and these quotes illustrate how hair loss can impact ones day-to-day life and how hair growth can ameliorate those impacts in an extremely meaningful manner. In closing, this 302 data is a meaningful step towards bringing a new foundational treatment to both the physicians, the treat hair loss and the tens of millions of motivated patients that seek treatment. We believe that this data supports a differentiated clinical profile in males with pattern hair loss and believe that this profile increases our conviction in our second male readout, which is anticipated in the second half of the year and in our ongoing female trial. Now from a female perspective, Minoxidil was validated biology in females. And in prior trials, we've achieved similar Minoxidil exposures in females that we've now shown in Study 302 are effective in males. Finally, we believe that 2026 is a transformational year for Veradermics. In that it's a year in which we will top line our final registration directed mail study, 12-month data from this 302 study and additional Phase II data in both males and females. In addition to advancing our clinical program, in 2026, we are making strides towards building a credible and independent commercial organization. Now before we open the call for Q&A, I want to thank the patients and investigators who made this study possible the investors who have made this company possible as well as the entire Veradermics team, who continue to deliver on an extremely ambitious vision. We're now ready to take questions.

[Operator Instructions] And the first question will come from Roger Song with Jefferies.

Huge congrats for the data, it's amazing and an impressive. Okay. Two questions from us. One is the -- in terms of the dose response between the QD and BID how should we understand that? And then more importantly, maybe is how you're going to decide which dose or 2 doses to file. A follow-up question is related to the commercial opportunity. understand initial estimated opportunity to maybe [ $1 billion to $2 billion ]. Given this impressive Phase III data along with the -- did the market rise over the weekend great. And then how this profile compared to the previous tested a commercially viable profile may change your initial estimated market opportunity?

Yes. So Roger, thank you for the question. I'll give two pieces of info and then hand it to Mark. One on QD, BID, the other on the commercial opportunity. From a QD, BID question, I think one of the big exciting pieces out of this data is just how strong the once daily data looks like. And I think that's something that we're very enthusiastic about. Now in terms of making a decision on QD, BID or commercial dose regimens, I think it's too early to do that, have another ongoing Phase III trial and have longer-term follow-up out of this study that's coming this year. And so at this time, I think just very excited about the strength of both the QD and the BID data and their ability to outperform our expectations coming into the study. I think my second question before I hand it to -- a second comment before I hand it to Mark, is about commercial opportunity. And as you mentioned, we had the opportunity to spend time with patients and physicians over the weekend. And I think one of the biggest takeaways that I had is that this data suggests that we are positioned to change the conversation about hair loss. What dermatologists tell us is that today, the conversation centers around a lot of expectation setting that stabilization is success. But with this data, the expectations have changed. The expectation is that you grow more hair. The question is just how much. And I think that, that is really a monumental step forward in the treatment of hair loss for both patients and their physicians. But Mark, I'll hand it to you for any other comments on QD, BID or how you're thinking about commercial opportunity from here.

All right. Sorry for that technical glitch there. Thanks for the question, Roger. Yes, I would just echo Reid's comments on QD, BID, we're obviously very pleased to see the results not only in the BID arm, which we studied in Phase 2 and had a high degree of confidence in, but also in the QD arm. And I think as Reid said, we'll await the results for the second Phase III study to confirm these. But obviously, very pleased at the performance of the QD arm that we saw there. In terms of your question about previous market research, as Reed had mentioned in his earlier remarks, the expectation for us going into these Phase III results was based on a quantitative study where we essentially had shown patients and physicians a profile that was in line from an efficacy perspective with [ Rogaine ] at 15 hairs and 25% or better on the PRO. I think it's fair to say the results that we saw in this Phase III study exceeded that and the results from the market research that we feel that this weekend also showed an even greater degree of perceived differentiation between VDPHL01 and the other existing therapies as well as an extremely high intent to prescribe on the physician's part and likelihood to talk to physicians on the patient's part. So while we've not provided any peak revenue guidance, I think it's fair to say we're very pleased both with the Phase III results that we saw in the clinical trial. And very pleased with the reaction we got from patients and physicians this weekend as they view the actual clinical trial results.

And the next question will come from Marc Goodman with Leerink.

Reid, talk about what you think expectations should be after 6 months for when a male is on this drug for 6 months. And then do you expect the data to continue to get better. And are we allowed to ask a question of the doctor, like doctor just curious if you think that this data for this product is enough better than oral Minoxidil that's out there today that patients will be willing to pay, let's just say, 8x more per month to use the product?

Yes. So I can start and then, yes, certainly, Dr. Sena can give her commentary. I think in terms of what are our expectations over growth over time. At this point, we don't have data to guide what longer-term outcomes look like. What I will say is that if you're someone who is longer here, while we can increase the number of pairs that grow, the time it takes for your hair to grow is still the same. So if you're trying to grow shoulder like there or beyond, may take additional time beyond what was seen in the study. So I think it's a reasonable question and something that as we get into the second half of the year, we'll have more visibility into I'll now hand it to Dr. Sena to comment a little bit on kind of the dynamic between whether patients and their physicians would be enthusiastic about prescribing this over the immediate release oral Minoxidil today, understanding there's a likely premium price. But Dr. Sena, go ahead.

Yes. So the first thing is patients are always asking if there's anything new, anything better to treat their hair loss. And in my mind, this provides a really great option. There's of course, a small subset of patients who are happy with their results on immediate release [ Minoxidil ] and will likely stay on it until their hair loss, eventually progresses, which happens in most cases. But the vast majority of patients who are on immediate release Minoxidil have and are not at their therapeutic goal. When we try to push their doses, not only does this lead to peak to the plasma concentration where we start to see more emerging side effects of patients don't like. More importantly, even when we push the dose because the immediate release Minoxidil that doesn't hang around the hair follicle long enough, we're not seeing incremental increases in hair growth. So I think a lot of patients are going to be one of these the vast majority of my patients are going to be wanting to switch over to this who are already on it. And I think for new patients coming in, it's going to be the obvious choice.

And our next question is going to come from Geoffrey Meacham with Citi.

Congrats on the data. Really good. Just had a few questions. The first is that maybe, Reid, when you look at best or worst responders from the data, is there a predictive factor or maybe a common feature that you can point to? And then on [ hyperthecosis ], just curious whether there's a pattern of where unwanted hair is present. And does that moderate over time from the patients in the Phase II/III?

Yes. No, great questions, Jeff. And I guess, starting with the question of what predicts response for the drug. And obviously, I think as you can imagine, we have a lot of subgroup analysis to do over the coming months to try and better to find that. I think qualitatively, our belief remains that with pattern hair loss, there does become a point where you're too far going on, right? You go from in fixed cater to miniaturization to follicular destruction or what has now been termed follicular depletion pattern hair loss. And for those individuals, if there's nothing to stimulate, right, Minoxidil growth stimulant, we think that they are less likely to respond in the areas that are banked out. With that in mind, in terms of formal subgroup analysis, not available at this time. In terms of the [ hyperthecosis ], I mean, I think the headline there is nobody discontinued the study for [ hyperthecosis ] because clearly, the trade-off between scalper and this [ hyperthecosis ] was in favor of the scalp pair overwhelmingly. In terms of specific areas, that's not something that we had in the top line readout would anticipate potentially additional information in the future. But again, I think the [ hyperthecosis ] discontinuation rate being 0 is extremely, extremely encouraging about the tolerability of this product, as was the remainder of the tolerability profile with what were essentially placebo-like overall AE rates in a placebo-like AE-related discontinuation rate.

[Operator Instructions] And our next question comes from Prakhar Agarwal with Cantor Fitzgerald.

Congratulations on these really strong data set. Maybe I had a few. So firstly, going back to the dose response, it seems that the QD and the BID dose are a little bit more tighter on the total hair count increase, but you are seeing much better response for the BID dose on the PRO. So maybe if you can elaborate on what the PROs are capturing beyond just [ non-velus ] total head count for the high dose. Secondly, could you confirm like how the second meal Phase III trial differ in terms of baseline inclusion exclusion? Is it similar to Study III or II? And what are the implications for the female trial now that's ongoing? And last question from me. What's the latest thinking on pricing, especially if both drugs make it to the market?

Yes. So I'll start with question number one, what's the difference between the hair count and PRO and what are they measuring what's different? With the hair count, you're getting a picture of 1 square centimeter in the transition zone of the scalp and getting a quantifiable objective measurement of the number of hairs greater than 30 microns within that square centimeter, whereas with the patient-reported outcome, the patient is viewing photos of their vertex and frontal scalp and then grading their hair coverage on a 7-point scale for much worse and to much improved. So you're getting more of a global impression of change in the patient's mind. Importantly, the investigator global, one of the other end points right, is also answered while viewing those photographs. So again, one gives you kind of a snapshot of a single area. One gives you a snapshot of the entirety of the scalp in the eyes of the patient or investigator. Now in terms of second question, about 302 versus 304, what's the difference? I would say they are markedly identical studies. The primary difference is that they're at nonoverlapping sites. So we had 44 sites in 302. There's been a different 44 sites in 304. So that's the primary difference in the studies. But I would not anticipate major differences in baseline characteristics otherwise. In terms of the final question on price, I'll hand it to Mark Newman to give commentary there.

Yes. Thanks, Reid. And we'll obviously make final pricing decisions much closer to the anticipated launch. But we do think we have a good in market benchmark in neutrophil, which is about $90 a month. And at that price point, neutrophil has been able to amass close to 2 million patients on neutrophil and generates over $1 billion a year. So we think that provides a benchmark for what patients are willing to pay in this category. Now we'll be conducting all of the rigorous pricing sensitivity and willingness to pay research that you'd expect us to be doing both with physicians as well as patients. And as we said before, we're very pleased with the results that we've seen in both the QD and the BID treatment arms. And we'll take all those factors into consideration when we make the fund pricing decisions.

Thank you. I am showing no further questions at this time, and I would like to thank you for participating in today's conference call, and you may now disconnect.