STRATA Skin Sciences, Inc. (SSKN) Earnings Call Transcript & Summary

We would first like to bring your attention to our necessary disclosures. Further, we would like to reiterate this webinar is being recorded. We would also like to highlight what we believe are risk factors related to owning shares of STRATA Skin Sciences. For any questions or concerns, please contact me [email protected]. Without further ado, I would like to hand the floor over to Jeffrey Cohen, Managing Director, Equity Research. Jeff, please go ahead.

Thanks, Destiny, and thank you all for joining us. We want to welcome Dr. Ben Lockshin today to speak with us about psoriasis, vitiligo and XTRAC. So Dr. Lockshin graduated from Brandeis and has medical degree from Georgetown University, residency at Indiana University and did further teachings at Case Western and Johns Hopkins. His practice is in Maryland and the Washington, D.C. area, where he specializes in medical dermatology. He's the Director of the Clinical Trial Center at DermAssociates and conducts various trials. As you can see, has been involved in more than 100 trials to date. So doctor is also on the Board of Directors for the National Psoriasis Foundation and also the Chair of the Research Committee for the NPF. He's been honored to join many scientific advisory council meetings, and he's also involved with the Chapter of the Lupus Foundation of America. So without further ado, Dr. Lockshin, thank you for joining us, and thank you in advance for speaking about XTRAC and psoriasis.

Jeff, Destiny, thank you very much for the introduction. Over the next 45 minutes, we'll cover basically XTRAC and the role for psoriasis and vitiligo. Let's see if I can just get that going. Well, that's me. I think Jeff did a pretty good job of introducing me. But I'm a board certified dermatologist the past 18 years. I've circulated through the academic and private practice worlds. I've been a private investigator for -- a principal investor, sorry, not a private investigator -- principal investigator for over 100 clinical trials, almost all focusing in the inflammatory condition disease states: psoriasis, atopic dermatitis, vitiligo, alopecia areata. In addition, I've written fairly extensively on these fields with both chapters and many peer-reviewed articles. Prior to enrolling anyone in a clinical trial, I have them sign a consent, I review what we're going over. Prior to initiating one of these conversations, I'd like to talk about my conflicts of interest. I am a speaker and consultants for pretty much any major company in the psoriasis, atopic derm, vitiligo space. So nothing here should overlap with any of those conflicts of interest. So phototherapy has actually played a role in terms of managing patients for thousands of years, dating back to 1500 BC when they noticed that actually smearing a plant extract on the skin actually intensified the reaction on the skin. And then over time, what we saw is we honed in kind of what was the meaningful wavelength that had a benefit without having significant side effects and drawbacks. And in 1923, Goekerman actually used a combination of using phototherapy plus tar to amplify the effects of the light source. But what we did see with this is a lot of collateral damage with skin cancers, photoaging, lentigos which is sun spots, et cetera. Then we went from broad-spectrum UV light to broadband UVB light, getting more specific, identifying that UVB light actually has very targeted effects in terms of decreasing the cellular turnover that we see in both -- in psoriasis primarily, and also the inflammation that occurs in many disease states, notably vitiligo, eczema and psoriasis. And that anti-inflammatory effect is central to these -- the benefits seen in these disease states. Then in the 1980s, what we saw is that there's a very narrow spectrum of this, 308 to 313 or 311 nanometers of light that is this range that has maximal benefit with very little liability or adverse events. And really, what we see is up to 200 treatments and probably well beyond that is that there's no increase in skin cancer rates using generalized phototherapy. Well, in 1997, we actually -- there was kind of an explosion in the '80s with laser technologies, and lasers uses the concept called selective photothermal lysis, which is one certain wavelength of light target specific colors or chromophores and it actually works in terms of decreasing inflammation, specifically the XTRAC laser, which is a 308-nanometer light. Laser is one specific wavelength of light, okay? So not only are we using a specific wavelength of light that has decreased effect in skin cancer, but we're also targeting specific lesions without targeting the -- treating the patient in general. Noneffective areas are not getting the light source with this laser source. And then really, in the last 20 years, 20-plus years, we really have a much better understanding of what psoriasis is and what atopic dermatitis is on a molecular and immunologic level. And this is just a nice illustration of what this narrow band of light column is. So we've got the x-rays going to -- gamma rays, x-rays, then UV light, then the visible spectrum, which is reflected here with this little rainbow, and then infrared, microwaves and radiowaves, but let's just focus for a second UV light. We have UVA, B and C, okay? Primarily, the UVA is causing a lot of the sunburns, but we see that also with UVB. We see that this narrow column of light that's seen with narrowband UVB light and extract laser is really what we're targeting for the maximal benefit in terms of cutting down that inflammation and reducing the signs and/or symptoms of psoriasis vitiligo and eczema. And what do we see here? Well, we have 4 different indications for XTRAC laser and it's primarily psoriasis, vitiligo, atopic dermatitis and leukoderma, which just really means white skin. Which if you look this up, it kind of overlaps with vitiligo, but there are other causes of leukoderma as well. What we'll show throughout this deck is that we have significant efficacy in terms of clearing the skin with few treatments for psoriasis patients. For vitiligo, we see high levels of efficacy, especially in the cosmetically sensitive areas, the face, genital area and [indiscernible] areas. And we also see benefits in terms of atopic dermatitis as well. And this is the evolution of these photo -- of these light sources. My father, who was a dermatologist, who retired after 50 years of practicing, when I was growing up, we had a broadband UVB box in our old office. And this is a pretty good illustration of what the new modern phototherapy boxes look like. They look like a time machine. There are also home units available for patients. They tend to be cumbersome, large. The light bulbs are fairly expensive, challenging to get covered by insurance for home use. But we've been involved in some studies looking at utilization of home phototherapy. But once again, this is a nonspecific generalized source. Just to complete the array of options. Over here, we've got the hand/foot unit as well as a localized unit. And then there's scalp and handheld units that are either sold with a prescription or even you can look on Amazon, which has less energy output. I will say I found very little utility using these localized light sources as I do think that the XTRAC laser technology is far more efficient and effective. And once again, you do have that -- the ability to have selectivity of these plaques. These handheld ones and scalp devices, patients are prone to overtreating certain areas or crossing over areas because of the lack of specificity. And these are the 2 devices that are used in the office. We already talked about the FDA indication and the rationale for this, which is allowing for targeted treatment of the lesions without treating unexposed areas. As we can see that this is not a fringe therapy. Phototherapy use has been endorsed by many of the guidelines we see, including the American Academy of Dermatology, psoriasis guidelines, the European Dermatology forum for Vitiligo as well as for atopic dermatitis, another AAD guidelines, which really are kind of the top of the pyramid in terms of evidence-based medicine. Guidelines are very helpful in terms of our decision-making processes and also play a pivotal role in terms of getting clearance from insurance companies and approval because the access to a medication is just as important as the efficacy of the product. A drug that is only as good as our ability to utilize and harness this. And I think that phototherapy is somewhat unique in its role because it's administered in the office, that it can be approved and used for patients with commercial insurance as well as the patients that have Medicare, which that Medicare population tends to be a more challenging patient population that we deal with because many patients can have coverage for these, but we can't employ any of the discounts. And as we know that many of the topical therapies as well as biologic therapies can be very cost prohibitive for those individuals. Let's just talk about epidemiology for a second. Well, we've got a lot of patients in the U.S. afflicted with these conditions. We have about 7.5 million patients in the U.S. alone with psoriasis, vitiligo numbers have been rising. If you look at some of the older literature, it says about 400,000 patients are suffering with vitiligo. But new reports and estimates look at about 2 million to 3 million patients in atopic dermatitis, spanning the spectrum of mild to moderate to severe, we see over 16 million patients. What's interesting is that these disease states are broken down into patients living in a mild category, moderate and severe. And I do think phototherapy plays a role in all these treatment modalities as you'll see a little bit later in this deck. So let's just hone in on psoriasis for a second. As I mentioned in the previous slide, about 7.5 million adults in the U.S., which accounts for about 2.5% of the population are affected with psoriasis. And it's a chronic autoimmune disease, okay, that basically causes hyperproliferation of the keratinocytes. Basically, a turnover of the cells at a higher rate than normal. We do know that this is a -- has a genetic basis for some patients. About 50% of patients will have a family member that does have psoriasis. But we also know that there are some environmental components that are playing a role in the initiation of this, a disease state. We do see that this does occur a little bit later in life and within a bimodal distribution where we see a peak around 30 to 40, and then another peak around 50 to 60 or 50 to 70. And you're like, well, why are patients or individuals developing psoriasis? Well, we do know some environmental triggers like strep infections, which can act as a super antigen which basically tricks your body -- body's immune response to basically flip that switch causing psoriasis. And once that switch has flipped, for the vast majority of patients, they're living in this new world of having psoriasis. And what we see is that like most things, and the same holds true for atopic dermatitis, is that most of our patients live in that mild category is less than 3% body surface area. In these guidelines, these groupings are based on National Psoriasis Foundation AAD guideline recommendations, which is just a touch of psoriasis, 3% is considered mild. So about 2/3 of those patients live there. About 1/4 of the patients are moderate, 3% to 10% body surface area. And then 10% body surface area or greater is seen in about 10% of those patients. No surprise, psoriasis has a major impact in terms of quality of life measures. I think the most pointing example of this is one of my patients who has bad psoriasis, but his sister, I also see, had bad lupus. And my patient, Allan comes to me and goes, "You know what, my sister, Laura, she's in pain, but she can just put a smile on her face, and no one really knows she's got lupus. Because it's just inflammation, she's got no cutaneous effects. For me, it's everything I do. I've got psoriasis on the back of my hands, my nails are affected. It's in my scalp. I've got scaling all over. He said I can't hide this. This limits what I do, my daily function. I don't feel comfortable getting in shorts. I don't -- I haven't been to a public pool in many years. So in addition to the other effects that he has holistically, the effect in terms of his self esteem and quality life is huge. In fact, when you look at the Short Form 36 scores, which really looks at the effect on quality of life, really only congestive heart failure patients actually had a lower score, and the lower, the worse, in terms of physical component, and really depression in chronic lung disease were the only 2 things that had lower scores in terms of the mental effect of this. So we see that this effect on quality of life is huge, comparable to cancer, psoriasis, hypertension, diabetes and depression. So thinking about this and thinking about treatments that can not only improve itch, but also improve the cosmesis, I think, is really meaningful. So let's take a sec talking about some of the treatment options that I present to my patients. So we have phototherapy, which incorporates really, in our practice, now, narrowband UVB light for patients with psoriasis and XTRAC Laser. There are other forms of light therapy that we do offer for other conditions, including broadband UVB and UVA and UVA1. But for the scope of this, really, narrowband UVB light and XTRAC are the central components to managing patients with phototherapy that suffer with psoriasis. There's a whole array of topical therapies. I'd say, for a long time, the cornerstone of therapies have been corticosteroids. And really since 1997, there hasn't been an introduction of a new topical therapy until those recently. And that's the aryl hydrocarbon receptor agonist, which is Tapinarof, but we also have vitamin D analogues, okay, calcineurin inhibitors for sensitive areas like tacrolimus. Retinoids and tar, which has kind of been more of a fringe medication alternative for many of these patients. In fact, in Europe, tar is actually not approved because of the potential for carcinogenesis, the ability to form cancers with those. Now moving to the systemic route generally reserved for patients with more significant disease, I think the biologics space is really kind of captured a lot of our attention. I think for -- Jeff and I were talking earlier, if you watch the news or watch the Discovery Channel or History Channel, you're going to see probably 3 or 4 ads for biologic therapies during the course of 1 new cycle. But there are also phosphodiesterase inhibitors. There will be a new introduction of the topical phosphodiesterase inhibitor soon, retinoids, methotrexate, cyclosporine in our space. So the systemic medications do come with a little bit of additional baggage. So some of these medications have risk for malignancies. We have risk for not only skin cancers but systemic cancers, from methotrexate. You have got liver function issues, effects on pregnancy for both men and women. Cyclosporine has effect on kidney function and high blood pressure as well as cholesterol. In my eyes, cyclosporine utilization, I think, is pretty consistent with everyone else is, it is a short-term fix for a long-term problem. So we really want to think about patients in terms of managing this long term. What's going to be an effective treatment option that doesn't put patients at short-term and long-term risk? And do patients really want to go on a systemic medication for the rest of their life, okay? And some patients with extensive disease, I think, are very open to that. For a mild to moderate treatment, I think that they -- me, as a clinician, and most patients don't feel that there's a good justification for utilization of these systemic agents for mild to low moderate patients. But where I do think that topicals and phototherapy play a role is in perhaps monotherapy for those mild patients and adjuvant therapy for patients that have kind of breakthrough plaques on systemic agents. And we'll talk about that a little bit later as well. And this is kind of the AAD NPF guidelines in terms of managing patients in each group. And unlike clinical trials where we wash patients out of a certain therapy and put them on just one agent, in the real world, this is more of an additive option. So for mild disease, we're thinking about other targeted therapies like XTRAC laser or topical steroids, which tend to be the cornerstone. For moderate, we have, once again, topical therapies plus phototherapy and systemic agents. Once again, additive effect, and then the same holds true for severe disease. I did want to add this slide in because I think that as a clinician, I like to be very mindful of the cost of medications, the value of the medication, and then for -- certainly, for psoriasis, pardon me, everyone wants to be better yesterday, so we talk about the speed. And then what's come up recently is the durability of response. And what that means is when you stop the medication, what's the remitted effect? How long can you go without needing to be on the medication again? And what we see is that XTRAC Laser checks many of these boxes. They have high rates of clinical clearance. The cost out of pocket for patients and also the cost to the health care system is minimal compared to some of these other medications. Jeff and I were talking about this earlier, which is there's a nice study looking at the cost for biologics to achieve a PASI 75. So how many patients does it take to actually achieve PASI 75 and then divide that by the cost of the medication, and looking at this in terms of metric. And what we see is many of these biologics, the cost to achieve a PASI 75 is staggering, somewhere between $50,000 and over $100,000 for some of these medications. Let's talk about the number. How much does this impact your quality of life? Well, to tell you the truth, the number of sessions needed to achieve these outcomes is pretty short. I tell patients somewhere between 10 and 20 treatments, you should notice a very meaningful improvement of your skin. And we see that for many of these patients, as you effectively treat patients, you see response rates as early as 3 to 5 treatments from my experience, this table shows 5. And then more importantly, the remitted effects. So once you're clear, you can have a nice vacation from this treatment. I tell patients when we get you clip, we're not going to treat those spots, okay? We're going to wait for them to come back and we're going to treat them again when and if they come back. And really, the side effect profile, we talked about some of the systemic agents where we're concerned about malignancies. These -- the blood pressure issues, kidney issues, et cetera, we have the common side effects that, "Oh, you can get a little redness and burning with the XTRAC Laser, and that's pretty much it. And I divide side effects into 2 different categories. The common, the rare and scary, there's really no rare and scary with XTRAC. It's more of the -- you might in to get some redness and some burning associated with it. And really, we don't see any meaningful amplification of malignancy signals with this device because of the specificity of what we're treating. So how does phototherapy work? Well, it induces apoptosis in T cells and keratinocytes. Apoptosis really means cellular depth and programs cell there. That's a natural occurrence in cells just in general. But what we see is this device goes after those cells that turn over quickly, causing localized immunosuppression of the skin. And what we see on a molecular level is we have a dysregulation of the immune system, overexpression of certain key cytokines, predominantly IL-4 -- I mean, sorry, IL-17, IL-23 cytokines as well as tumor necrosis factor alpha. And no surprise, these are really the cornerstones of therapy for the biologic agents. And we see in skin biopsies and also cellular tape strip assays that we see reduction of these cytokine profiles in patients that are receiving phototherapy. And I'm not really good at taking pictures of my clinic. Sometimes, I need to do a better job, but these are some of my colleagues' photos. But my experience have been pretty consistent with this. And what we see is before the treatment. And this patient, I would classify as an IgA4, which is pretty severe disease, large thick, scaly plaques on the knees and shins. And what we see is after treatment, we see a little post-inflammatory erythema, which is the shadows of some of these old spots, but a dramatic reduction. And as I'm going to show you a little bit later in the deck is with time, this actually reduces as well. And this is pretty consistent with any of our treatment modalities is the shadows of the disease state tend to linger for psoriasis and eczema. Another example of a well circumscribed psoriatic plaque and after 13 treatments okay, either twice or 3 times weekly, we see a very meaningful reduction. And I will tell you that the farther away from your heart, the more prone you are to getting this post-inflammatory change. So areas on the face, scalp, arms and legs, the clearance of this tends to be faster and more reliable. And I think this is -- this picture is not a great illustration. I probably shouldn't have thrown this in with scalp, but it's a good reminder that we are treating the scalp. This is actually adjacent to scalp. But let's just talk about just a study looking at a retrospective chart review. And what we see is that we have the -- about 50% of those patients achieved 59% clearance. And then in a scalp, which is identified as a tough-to-treat area, scalps and palms and soles as well as genital areas, and we'll really talk about where this is the sweet spot. In my eyes, this is the #1 treatment for managing these patients, and about half of those patients achieved greater than 95% clearance. So we see -- when patients respond, they respond very nicely to this treatment modality. Palmoplantar disease very, very, very challenging no matter what treatment option you use, from biologics to classical small molecules, this is where this shines. And I will say that it is very challenging for us, not only clinically, to diagnose palmoplantar psoriasis in many patients if we don't have other clues like psoriasis in other parts of the body. Histologically, it can be equally as confusing as psoriasis and eczema can look very similar in terms of clinical appearance and histological appearance. And the nice thing about XTRAC Lasers, once again, you have -- you can dial up the fluence to the palms and soles, and it can treat both diseases. So without having to truly understand the etiology of it, psoriasis or eczema, we can get this better. And we can see that on the palms, these deep fissures accounting for effect on quality of life, doing anything is challenging when your hands look like this. And then what we see is after 16 treatments, a real meaningful improvement in terms of the scale of the erythema and the fissuring. I think that the exposure of these is a little off. All of these just showing a little bit of -- a little too much redness. But this is a very happy patient. I've had many patients that fit right into this category as well. I'm not going to spend a lot getting into the nuts and bolts of various clinical trials, but this text box down at the bottom really kind of is a meat of it. Looking at a pool, a meta-analysis of 13 different studies, what we see is about 61% of the patients achieved a PASI 75 with targeted UVB treatments, which is [indiscernible]. And what that means is that a 75% reduction of that PASI score, and a PASI score is a score from 0 to 72, it's kind of almost like a logarithmic score. And a 75% reduction generally translates into about 90% improvement of the skin from my assessments in my clinical trials. So what we're doing is looking at erythema scale in duration, thickness and body surface area and looking at that as a Gestalt score. And then where does this fit in, in terms of treatment, in terms of the strength of recommendations? Well, the Journal of the American Academy of Dermatology, which is really our main reference journal as a practicing dermatologist, shows that phototherapy has the strongest level of recommendation for treating patients with localized disease, okay? It also has strongest recommendation in terms of having -- inducing remission, keeping people better. And then looking down in terms of tough-to-treat areas like the scalp and also as an additive adjuvant therapy, it is a -- has high levels of recommendation, which once again, is meaningful to us as clinicians and also helpful for us as clinicians getting it approved with the insurance companies. So what is XTRAC's role in terms of my patient management? Well, as I mentioned earlier, I think it's a great treatment option for those stubborn plaques, for patients with mild to moderate psoriasis. So if they have just a dime-sized lesion to a number of little what we call guttate or drop like spots, I think it works great. I think that for tough-to-treat areas, this is really spot on. Traditional phototherapy does not get it through the scalp where XTRAC Laser does. You can split the hair and put that handpiece on each spot individually. You can do this in a matter of a few minutes. And then palms and soles. Once again, it does not discriminate if it's psoriasis or eczema. And even for someone like me who lives and breathes psoriasis, eczema, vitiligo, these inflammatory conditions, this can be very difficult to differentiate. In addition, those patients that are on systemic therapies, many of the patients are not completely clear. So it's a really nice adjuvant therapy. I'd like to call it touch-up paint, hitting those spots that are just stubborn. Because how many of us have walked around with an acne spot on our forehead and get bent out of shape? So being -- having 30% body surface area going down to 5% or 2% body surface area, that 5% or 2% is still distressing to them. And in terms of benefiting the health care system, it's very, very expensive to change biologic agents. The loading dose of many of these medications is just as expensive as 2 years on maintenance of these medications. So being able to utilize an adjuvant therapy that's safe and effective can delay switching biologic agents for these patients, helping curb costs for health care expenses. And for many of my patients, and I had someone probably about 30 minutes prior to this meeting, is -- she didn't want to go on a systemic therapy. She's a nonprescription kind of girl, and she wanted a nonmedicinal option, and this really fits that bill. It's a natural option that patients feel comfortable with. And I feel comfortable knowing that this is not going to increase the risk of skin cancer, and it does not have any systemic effects. So many of the patients gravitate towards this at least as a first-line option prior to initiating treatment with biologic agents and for those patients who are not candidates as well. Life is all about managing expectations, and the same is true with this. And I tell providers in our group and when I speak to my colleagues around the contrary, say, these are what you should expect to see when recommending this product, and I tell the same thing to our patients. They're going to come 2 to 3 times a week. I'd like to space them out with 48 hours between the sessions ideally. The average time to improvement, I set the bar low. I tell them between 10 and 20 treatments, you're going to notice a major improvement. But patients start to see meaningful change much earlier, somewhere between 5 and 10 treatments. And this is really where the money is. Once you're clear, you can have periods of time with remission that lasts up to half a year. And patients love hearing this, so they come early spring. They do their sessions, and they know throughout the summer, they can live without slipping in and out of our office, okay? And I do tell patients tough to treat areas, irregardless of what treatment option you use, are tough to treat. So scalp, palmoplantar disease may take a few more treatments. And this is a really good representation of what patients look like before treatment. And I would classify this as a patient that has a moderate disease based on an IGA scale, which is Investigator Global Assessment. We see that post inflammatory erythema after 11 treatments. We see it diminishing after the 13 treatments. Well, treatment was probably stopped at 13 treatments here. And after a year of treatments, they are not only clear, but we see that complete resolution of the post-inflammatory changes. And the darker your skin, the more prone you are to getting it. Just like I mentioned earlier, the farther away from your heart, lower extremities, the longer it takes for that to diminish as well. We'll answer questions at the end. We'll shift gears for a second and move on to vitiligo. Well, we talked about the epidemiology of these disease states earlier. I'm just going to refresh your memory. We see newer data actually shows JAMA Dermatology, about 2 million to 3 million adults in the U.S. suffer with vitiligo. It was really just underrepresented for a long time, primarily because, to tell you the truth, we didn't have too many good options for these patients, and they kind of just disappear. They learned to just live with it. And we'll talk about some of the strategies they use to live with it that circumvented medicinal treatments. Vitiligo can appear at any age, given about 1/3 of the patients with vitiligo are children and it progresses through adulthood. 75% of the adults developed vitiligo before age 30, and these really are in the formative years, and we're going to see that the younger patients have much greater impact in terms of their quality of life with this disease state. The older people just tend to -- I hate to say it, they become acclimatized to it and they just learn to live with it. And that's not right. Prevalence of vitiligo, we talked about U.S., what's going on outside the U.S. We tend to be somewhat xenophobic in terms of our data, but we see pretty consistent numbers. And a lot of literature that's actually coming out of Vitiligo happens to focus around the Indian patient population as well as Asian population because it is stigmatized a lot greater in those groups. Moreover, we see -- what's surprising to me is that the quality of life measurement effects are pretty consistent. It doesn't matter if you've got very fair Scandinavian skin or Sub-Saharan black skin, patients are very distressed, especially when this involves the head and neck areas as well as the hands. And we see, just as I mentioned earlier, quality of life indices for vitiligo can be elevated to a significant amount in patients that have head and neck lesions. And the DLQI, which is the Dermatology Quality of Life Index, the range goes up to 14 and some change. What does that mean to you? Well, what we see is that 5 and above goes into the moderate distress. When you get above 10, you're in severe distress in terms of how this affects you, okay? And we talked about how this affected people with psoriasis. What we see in terms of the psychological impact that this can sometimes be worse, especially involving the face in patients dealing with psoriasis. Vitiligo's mental and emotional burden is comparable to both of these other disease states we talked about in terms of hand eczema and psoriasis. And no surprise, this can actually disrupt intimacy issues. And I always ask patients with psoriasis and eczema, do you have involvement in the genital area? And just like we talked about, don't ask, don't tell. If you don't ask, they won't tell. And many of these patients are really bothered. They are self-conscious of the fact that new partners might feel that this as a sexually-transmitted disease or this is infectious in nature. And we talked about areas, including the face and hands. Imagine being in an industry where you're presenting yourself and you have deep pigment of patches on your face, neck, hands; it's distracting. Even though this doesn't affect their longevity in terms of systemic effects, this has a major effect in terms of psychological burden. In many societies, the etiology is poorly understood in the community. And people thought that this could be a sign of leprosy, and there are forms of leprosy that do have deep pigmentation. I can certainly understand how this could be confused with this. Or as I mentioned earlier, many people think that this is transmitted sexually or is contagious just in general. And this is a great example. I've seen many patients that are just like this that have really meaningful responses to phototherapy. And the nice thing is this treatment sticks. So when you clear a patient, most of the times, the remission lasts. Somewhat indefinitely from what I've seen, some people do need a little bit of touch up. So what we see is that phototherapy stimulates melanocyte proliferation and melanogenesis. And so as we see with tanning just in general, the tanning causes increase in melanin production. This also causes repopulation, receding of -- like receding your yard of melanocytes. It induces that T cell apoptosis, that cellular depth of these T cells, which basically are causing the inflammation driving this disease state. So what are the current treatment options that we have? Well, let's start at the bottom. Many of the patients that don't come to our office really just resort to derma blend or camouflage, using makeup. And to tell you the truth, some of the makeups actually work pretty darn well. But that's not really an effective treatment for many of these patients. Phototherapy, either narrowband or XTRAC therapy, I think, are great. To tell you the truth, many times, I'll use them concurrently for these patients. And then topical treatments, most of these are off-label, including JAK kinase inhibitors, corticosteroids. Calcineurin inhibitors are the cornerstone for my treatment for these patients that are using topical therapies like tacrolimus. Vitamin D analogues, I think have minimal benefit, but are in that treatment ladder. And really, we throw pretty much everything we have at these patients because very few of the topical therapies work by themselves. And I think that using topical therapies in conjunction with phototherapy does have some additive benefit. Well, the good thing is for everyone suffering for vitiligo is there's a big pharma company now shooting out ads over and over again, talking about their new topical treatment. And let's just look at this line. This is actually stolen from one of the pop-up heads that I got when I was surfing the Internet. And it says, it is the first and only FDA-approved vitiligo prescription treatment that helps to repigment skin. Well, technically, it's a prescription treatment, I guess, using a cream. But it is not the first FDA-approved treatment because, once again, XTRAC, in my eyes, tends to be something that is overlooked. It doesn't get the attention it deserves. There aren't a lot of people speaking at the podium, talking about why this is a great treatment option because there aren't a ton of studies that are going on. There -- a lot of the data tends to be 5, 10 years old, but it's great data. And when it's not new and fresh and there's not a lot -- there's not billions of dollars of pharma money being spent to gobble up ad spaces, it tends to be an afterthought, less people are very involved in using this treatment option. And the data actually, from OPZELURA says that nearly 1 in 3 patients achieved at least a 75% improvement in facial vitiligo at 24 weeks. Well, 33% is not that great. But let's just see how that stacks up to what we see with XTRAC Laser. And we do see that the vitiligo working group, once again, treatment guidelines from 2017, really does show that it is really the main treatment of choice for managing these patients, and the European guidelines mirror those as well. So we talked about 1/3 of the patients having a 75% response to their vitiligo. And remember, in this clinical trial space with OPZELURA, and in full disclosure, I was an investigator for the study, is that OPZELURA patients that were enrolled in these studies really had to fit in a very narrow spectrum of the disease state where they couldn't have vitiligo for really long periods of time. They had to have it in select areas. They didn't have -- they couldn't have very extensive disease. This, which happens to be a retrospective chart review of real-world evidence, which is a muddier patient population, which really emulates what we see in our clinical trial space -- I mean, in our clinical patient space, is that 75% improvement was seen on the face about 75% of the time. 50% was seen in 4 out of 5 patients. And then as you go down to tougher to treat areas, we see close to 2/3 of the patients have 75% improvement on their neck and scalp. Genital improvement, we see about close to 3/4 of the patient have 50% improvement. And then trunk, we see about 50% as well. And hands and feet, to be honest, I tell patients to set expectations very low. Nothing gets this better. If you look throughout the literature, everything's been treated -- tried to treat this. I have one of my colleagues who works in a different practice who's come to me for pretty much every different option to manage his limited vitiligo is hands, and we really have made very limited headway, unfortunately. Here's is the important thing: this textbox says no pigmentary loss during the 2-year follow-up in this retrospective chart review, okay? As I talked about this earlier, unlike psoriasis, this sticks, and this has a meaningful impact in terms of restoring that pigmentation. And these are just some other studies. What I will tell you, as I mentioned earlier, is there's not a lot of studies that have been produced in the last 10 years on this. This is from 2005, looking at studies with small patient populations. And I think it's important to raise awareness. And the best way to raise awareness is having new investigator-initiated studies looking at this. We're storing interest in this because I think that having physician interest, understanding the benefits of this treatment option, and getting this into the hands of the right providers and also educating patients about the benefit of this. And once again, safety and efficacy, that balance, I think, is really, really -- there's a large chasm between the safe -- the data in terms of safety and the limited side effect profile that we see. And I have a number of patients that look just like her. I wish I took pictures of them. But I mean, this is a patient who comes in and gives you a hug, you've changed her life. She's a type 4, 5 skin individual, darker complex-ted. This is almost impossible to camouflage. And what do we see? It does take a number of treatments, but we see really after 5 treatments, we see a reduction. And to be honest, I think this is a little bit earlier than what I classically see. But I see this after about 20 treatments. And then really, here's where the money is, once again, durability of response. And just like for psoriasis, I'd like to set expectations for patients and providers. 2 to 3 times a week, separating them by 48 hours or more, repigmentation. I tell patients come back after 20 treatments. Let's see how they go. I tell patients they can take up to 100 treatments because if I tell them 100 and it's really 50, they're thrilled. And once repigmentation is achieved, don't treat those areas. Once again, it's going to stick. Patients love hearing that. This, unlike, psoriasis, doesn't have the dispigmentation in the shadows because, once again, you're just treating the areas to induce repigmentation. And this, in my eyes, is far superior to generalized phototherapy because with generalized phototherapy, you're tanning the rest of the body, increasing the contrast between areas that have no pigmentation and the areas that tan with pigmentation. And as I mentioned earlier, let patients know. Managing expectations in terms of the tough-to-treat areas, including acral areas, hands and feet, are important for patient satisfaction and also for patient compliance. If patients don't start to see it in one area, don't see it in another area, if they're not coached, they're not going to continue treatment at the same rate. So taking things full circle, let's talk about the key takeaways from this presentation. We've got an effective treatment option for patients suffering with psoriasis and vitiligo irregardless of the spectrum of disease from mild, moderate to severe, it's cost-effective, and it has a very good safety profile for these patients. It's a nonpharmaceutical approach to managing these chronic diseases because people think about the cumulative exposure of these medications. And certainly, as we've seen cumulative exposure to topical therapies. A recent article from the Archives of Dermatology from January or February of 2021 showed that patients using topical steroids have an increased risk of osteoporosis and bone fractures in a dose-related curve, meaning the more that you use, then the higher the rate of that is. So using topical steroids is not trivial. There is some systemic effects with that over time. It can be used in all body sites, and especially in those tough-to-treat areas, which I really think are where this excels, which is palms and soles and scalp. And to tell you the truth, scalp is the first area of involvement that we see in patients with psoriasis. And really, this is a treatment for disease states that this treatment option is often the stepchild, no disrespect to stepchildren here, but it falls into the back of our mind sometimes if you don't have it in your clinic or you don't have a clinic close by that offers it. So making patients aware of the options, because as providers, we are in the unique position to talk patients in or out of treatments, talking about the safety and efficacy, or overlooking either accidentally or intentionally some of these agents. Some of my colleagues don't feel comfortable prescribing cyclosporine or methotrexate, so it's not even in the discussion. And for phototherapy, I think it's not feeling comfortable about it, it's just forgetting about it and putting it back in the center of their scope. So I think as a clinician, making providers more aware of the utilization of this. And certainly, there's a value-added benefit that this is a win-win for the providers. It is an economic benefit for me as a clinician, even though as a provider, my job is to do what's best for the patient first. That's always #1. But there's certainly some benefit of making sure that our business is above water, that we're making money. So having a win-win certainly doesn't hurt at all. So at this point, I'm going to pause, open it up to any questions that you guys may have about either the treatment modality of these states or anything in this space.

Awesome. Thank you.

Destiny, I see a couple of things in the chat. Do you want me to just address this?

Please.

Sure. Absolutely.

So there's 2 questions. What is your perspective on efficacy regarding UVB light therapy at home? I don't know what the [ Zerio Health ] is, but I will tell you, I am involved in a study in partnership with the University of Pennsylvania looking at the efficacy of home phototherapy versus office-based phototherapy. I do think that home phototherapy is a reasonable option for patients that live very far from our clinic. I do think there are some shortcomings in terms of, A, patient utilization and limited oversight as many of the treatment options will allow patients the devices. I'm most familiar with the [ Davan ] units or National Biological Corporation units, where the minimum number of sessions you can go down to those patients is 75. So those patients are kind of running off into the wild. I have had patients that have sustained burns with their home units. In addition, it does require some space at their house. But I do think that even though they do have fewer bulbs resulting in lower fluency and taking more time, I think it's a reasonable treatment option. And then the next question is, what percentage of patients with psoriasis would you categorize as moderate versus severe? And what we see is that the lion's share of those patients are mild in nature. We see about 2/3 of those patients. We see about 20% or -- I think it's 24% are classified as moderate, and about 10% live in the severe category. So the lion's share of those patients do fall in that lower end of the spectrum. I will say there's 2 different ways to categorize this. As I mentioned, mild, moderate, severe, broken down by body surface area for the NPF is just a touch to 3% is mild, 3% to 10% is moderate, greater than 10% is severe. Another way is actually stratifying based on a PASI score or a PGA. A PGA is a physician global assessment, which is often utilized in the clinic, which does not take body surface area into account. And it's really just the thickness of the plaque. You can have one little tiny area that's super thick that could be severe -- categorized as severe, or patients with very extensive, very thin plaques that could be mild or moderate. So generally, what people in the clinics are doing, and there's been advocacy towards switching our assessments to a BSA, body surface area, times a PGA, physician global assessment, to provide a global score. And then the last scoring strategy is something that I presented at the summer AAD meeting at Vancouver about a month ago is something called the OPAT, which is using one patient recorded outcome, or PRO, plus BSA, body surface area, and that really actually represents and is very consistent in terms of scoring of the PASI score and that DLQI score. I probably missed it, but is there any benefit to eczema for phototherapy? So it was brought up at the beginning. It is indicated for patients with eczema. So phototherapy, in general, I think plays a very nice role in terms of management of patients suffering from eczema or atopic dermatitis. And XTRAC Laser also does a really nice job for stubborn areas, especially those patients with palmoplantar disease or eczema involving the scalp. Very good questions.

Great. And then Dr. Lockshin, we had one come in via e-mail. Based on your commentary around there not being quite as much current or newer data on XTRAC, as someone who's been involved in a lot of clinical trials, what kind of data would you like to see be presented at some of these kind of scientific conferences or podiums? And what kind of trial design do you think would be necessary to generate that type of data?

Excellent question. So the reality is the data is already here. And the -- it's hard to get this built into our nonbranded from the podium national presentations when I'm asked to give new and emerging therapies because this isn't a new and emerging therapy. So pulling something that is 15 years old, even though it's great data, doesn't have the same pizazz or wow effect to talking about a brand-new mechanism of action with the biologic agent or newer data incorporating brand-new small molecule agents. So I would -- if I were working for, say, STRATA or as a clinician and I had more bandwidth, I would seek out a company like STRATA and say, "Hey, I'd like to do an investigator-initiated study or partner with the company, talking about having patients using combination therapy or treating patients specifically with tough-to-treat areas and getting newer publications out there. And pushing this to the KOLs and saying, hey, we've got new information. These are some new pictures, and most of my colleagues and myself are very receptive to adding this on. We've gotten very little up to this point in terms of fresh information or photos to present to our audiences. And generally, in my nonpromotional decks, it's one slide, maybe even one line that's dedicated to XTRAC. Not because I don't want to talk about it, because I think it's a great option. It's just there's nothing fresh. It's kind of a hacking discussion point, and it makes me look like I'm not presenting new data if I have something from 15 years ago. So I think also making sure that you continue to have an active place in the guidelines, working with the National Psoriasis Foundation is really good. But yes, circling back, having more investigator-initiated studies, you don't have to have large numbers, just freshening up that information.

All right. Thank you for that. Jeff, I know you had some questions, so I'll hand it over to you.

Dr. Lockshin, again, thanks for the presentation. It was awesome. There are a couple of questions. So why is it mechanistically why you don't have to retreat patients after a therapy on vitiligo versus psoriasis?

It's an excellent question, and I'll start by the, we don't know exactly. That's the truth. But what we do see is that with vitiligo, there's probably some initiating event that causes depigmentation and then it does fizzles out. And then once the melanocytes are -- once there's a vacancy sign up, there's no more pigmentation. So using a therapy like XTRAC to stimulate the reappearance of those melanocytes that occupy the basal layer of the skin, then they'll start producing pigmentation. And what we'll see once we start seeing some reappearance, you see it around the hair follicles as those tend to be the reservoir for some of those sleeping melanocytes. So unlike some constant internal flame that's fueling the fire, I think that the vitiligo is almost like a squirt short. The fire is gone, but the foliage is -- there's no flame, but there's no foliage. We need to get -- we need to repopulate the field.

Okay. Got it. And then I'm going to throw in one more as we have one more minute. So are there any trends out there about using combination therapies, meaning such as a biologic along with UVB or phototherapy light that's going on, and how might the payers react to that?

Excellent question. So another one of my favorite talks that I give our academy meetings is clinical trial data versus real-world data and how they complement each other. Clinical trial space is a beautifully manicured patient population that fits nicely in this neat box generally on monotherapy. The real world is a messy, messy place. We're throwing pretty much everything at them in an additive approach. So many of these patients are getting -- that have -- that are on a biologic agent that are in the moderate to severe category that still needs something to give them that added umpf to get them clear. Quality of life measures are dramatically higher in patients that are clear versus patients that are even almost clear. So in terms of payers, we get almost no pushback in terms of adding phototherapy. Especially when you look at the price point, where you're looking at between $1,000 and kind of $3,000 annually for photo -- for XTRAC Laser for a treatment course as opposed to some of these new topical medications, steroids or hydrocarbon receptor agonist, which just for a 60-gram tube can cost -- the average wholesale price could be $2,000. So from my experience, very limited pushback about adding this on.

Fantastic. Destiny, do we have any other questions? I know we're running low on time.

No, I believe we answered all the questions.

Wonderful. So Dr. Lockshin, again, thank you so much. That was super comprehensive and informative, and hopefully, folks get a better view of what's going on out there in the marketplace. Certainly, any follow-up, feel free to reach out to us and we're happy to accommodate it. So again, thank you all for joining us.

Thank you very much for your time and attention. Have a great day, guys.

Thank you.

Thank you. This concludes our webinar. You may now disconnect.