My name is Greg Renza, one of the equity research analysts here at RBC. For our next session, we're pleased to have Verrica, and the Chief Executive Officer, Ted White. Ted, thanks for, thanks for joining us. Good to see you.
Thank you, Greg. Appreciate it.
A lot going on. We can say that Verrica is a commercial stage company, and you've had a nice running start with YCANTH. Maybe for those who aren't familiar with the Verrica story, maybe offer us a brief introduction of the company, the lead asset in Molluscum, and even touch on the pipeline.
Sure, happy to. So, Verrica Pharmaceuticals, we're a dermatology therapeutics company based outside of Philadelphia, Pennsylvania, in West Chester, Pennsylvania. We're really focused on addressing high unmet needs within medical dermatology, and our lead asset, YCANTH, was just approved July last year for the treatment of molluscum contagiosum, which is a highly contagious viral skin disease that affects 6 million in the U.S., primarily children, ages two to 14 every year. Up until YCANTH, there were no FDA-approved therapies, and so, as you mentioned, you know, we're in full launch mode there. We also plan on looking at other indications for YCANTH, including common warts, external genital warts, and plantar warts. So when you think about it, the product has the ability to affect, you know, 10% of the U.S. population.
In addition to YCANTH, we have VP-315, which is our first-in-class. It's a first-in-class oncolytic peptide that we're currently in a phase II trial for basal cell carcinoma. So this would be a non-invasive procedure, an alternative to Mohs surgery. And we expect preliminary top-line results by the end of Q2, so call it, you know, mid to late June.
Yes, certainly with three opportunities across a spectrum of maturity, with an approval, a phase III-ready asset, an opportunity with warts, and then also a phase II in an additional indication. So nice optionality and kudos for really just building and delivering on this dermatology platform. And it is all about YCANTH now, and you set the stage a bit on molluscum and some of those numbers. Maybe just walk us through the presentation of molluscum, the progression by age. It may be an area that many parents and many families know, many investors certainly are aware of it, but you're certainly tuned into the nuances and how YCANTH certainly fits in.
Yeah, sure. So listen, molluscum is one of the top 50 diagnosed diseases worldwide. But to your point, a lot of people never heard of the disease. And as I mentioned, it, you know, as the name implies, contagiosum, it's a very contagious viral skin disease. And it presents with a, a... The typical patient presents anywhere from 10 lesions-30 lesions. That's on average. And the challenge is, what happens is these children typically pick and scratch at these lesions and then touch other surfaces of their body and spread the disease, and auto-inoculate themselves. So it becomes a real challenge. And then, of course, if you have siblings, you have a 50% chance of spreading the disease to a sibling. And then when you're in school, all the lesions have to be covered.
So it becomes a real challenge for parents. And also, there's a social stigma because it affects playdates, extracurricular activities, etc. So that becomes the challenge.
Yeah. And how do you capture and summarize some of the feedback? We certainly hear them from families, but what about the clinicians that maybe the burden that molluscum can incur on their practice? And we talked to the pediatricians, we talked to the derms, and even the primary care docs. So what is Verrica doing to collect that feedback and actually implement what you're hearing from that community?
Well, listen, I think the good news is, you know, this is a disease that typically the first line of defense is the pediatrician.
Yeah.
Because pediatricians, up until YCANTH, had nothing to treat the disease, it was typically wait and watch.
Yeah.
Okay? Then, if the parent was adamant about therapy, then they would refer them on to the dermatologist. Now that YCANTH's available, they have a safe, effective product. We're seeing adoption by pediatricians. A lot more interest now in treating the disease. We were just listed in the Red Book, which is the guidelines for infectious disease in pediatrics, so YCANTH was just-
Mm-hmm
... published in the book, so that's, that's gaining a lot of traction with the, among the pediatricians.
Great. And how are you leveraging the applicator? Certainly, ease of use is important, so went from watch and wait, maybe for some home remedies, if you will. There are treatment options that could be emerging at home, but really, as the first FDA-approved, you're well-positioned, and the aspect of convenience is key to sort of that leveraging and improving that clinical efficacy and also that tolerability. Just talk to us about how the applicator does deliver on that.
Yeah, well, I would say the applicator is the star of the show-
Yeah
... because now you're enabling the healthcare provider to precisely put on the cantharidin to the exact size of the lesion.
Mm-hmm.
You know, when there was compounded cantharidin available, it was challenging because they put it on with a wooden stick, a very antiquated way. But we're doing a lot of work around training. We're doing, you know, live training, virtual training to make sure that, you know, the end user is having a positive experience with the product. And the feedback we've gotten has been tremendous, 'cause now, again, they can put the medication on precisely to the size of the lesion.
Mm-hmm. Great, great. And then, of course, it starts with access as well, once an approval occurs. You have a J-code now issued. You've done sampling programs. So maybe just elaborate a bit on the aspect of the J-code, the access that's opening up and the receptivity from the payer front.
... Yeah. So, first, I'm really happy to report that we have 228 million lives that have covered commercially, and that includes Medicaid and federal programs, state programs, et cetera. So the key to any launch is obviously reimbursement and coverage. And then, as you mentioned, our J-code was published April first, and happy to report we tracked the top 106 plans, and the J-code is published amongst all those top 106 plans, representing over 190 million lives. So we feel really good about that.
We definitely saw an uptick in spike in, in utilization and also interest in, buy-and-bill accounts in April, due to the publishing of that J-code, because it just gives, healthcare providers assurance that they're going to be reimbursed. So we definitely, definitely saw a nice uptick.
Yeah. And just with when it comes to incentivization, how does this model actually play into empowering the clinicians, ultimately dermatologists, but then really encouraging that upstream adoption of YCANTH?
Yeah, well, listen, I think our opportunity, what I like about it so much is it creates a partnership.
Yeah
... between us and, and the healthcare provider, because obviously, there's, not only we providing a safe, effective, medication, but there's also the revenue opportunity, right? So, for healthcare providers, they'll get their normal office visit fee. There's an additional CPT destruction code for the treatment of the lesions. And then, for those physicians that, elect to buy and bill, then they'll have an opportunity for, to get revenue on the product and ASP plus model, depending upon their individual contracts with the payers.
Okay, great. As far as you building your organization, that infrastructure, working with Joe and the team, what's the latest on the numbers, the size of the go-to-market and sales force, and how you're organizing around the number of prescribers and the clinics?
Yeah, so currently, right now, the field force is we've got 53 dermatology representatives in, you know, call it the top MSAs across the country.
Mm-hmm.
And then we have seven institutional representatives that are focused on major teaching institutions, children, pediatric institutions. And then we have 20 representatives that are dedicated to pediatrics, and they're in the top 20 MSAs focused on pediatricians.
Nice. Nice. And then seasonality comes up with molluscum. The prevalence changes through the spring, the summer, fall, and entering school. How does that actually plan now tie into the launch? It's always difficult to predict, but I'm sure there are some base cases that you're thinking about as far as harvesting that.
Yeah, no, great question. So, first of all, molluscum is seen all year round, but you definitely do see spikes in the warmer weather months. So we're getting ready to hit that stride as we speak. You know, kids that are getting ready to go to camps, you know, kids that are at swimming pools, this is where you see a bolus of these patients. So, you know, we definitely expect to see an uptick in the number of molluscum patients coming up here in these next few months.
Nice. Nice. Great. And then just talk a bit about Orange Book listing and just the IP and how that positions YCANTH.
Yeah. So look, when you think about the intrinsic value, you know, while cantharidin has been around since the 1950s, it's never been FDA approved. And there were some people who had some questions about whether or not we would get NCE status.
Mm-hmm.
So we have NCE status. We're Orange Book listed, so five years exclusivity. And then we've got patent protection on our formulation and also our applicator. So, and then I think we've talked about in the past that we've also been working on a synthetic version of cantharidin. So we have that as well, ready to go. So when you look at all the patents, you know, for the method of use, for the applicator, for the formulation, it takes us out for the next couple of decades, out to 2041. So we feel really good about that. And plus, we also have other indications that will be coming, you know, the common warts, you know, external genital warts-
Yeah
... things along those lines.
Yeah, and you touched on that, even on your earnings call, which was only two days ago, if I recall, just a couple of days ago, on the plans for the common wart study. And also spoke about the agreement with Torii Pharmaceuticals. What are the updates there and the latest on the phase III plans, the phase II results, and then also just the general timelines?
Yeah, so listen, we're really excited about our opportunity with the common warts, which I say is the holy grail of dermatology, 22 million prevalence in the United States, no FDA-approved therapies. So a tremendous opportunity, huge addressable market. Our partner in Japan, Torii, has been phenomenal. As you saw this morning, we announced that, you know, Torii is basically fronting us the funding for this phase III program. This is based off of our expected milestones that they'll receive for molluscum contagiosum in Japan. So it's going to be, you know, a negative impact to our cash runway to conduct the study. We have the green light from the FDA to go into the phase III study, but we'll do it. We'll have one more meeting with the FDA.
The Torii has to have a meeting with the PMDA.
Mm-hmm.
We'll look to start the trial in the, let's call it, first half of 2025, so it'll be a global phase III program between the U.S. and Japan. And again, we, you know, we could not be more excited about the opportunity. I think it's also important to note that I think it's very de-risked.
Yeah.
I mean, our phase II trial, we showed 51% complete clearance. And again, cantharidin, while being the gold standard for molluscum, it's also a gold standard treatment for the treatment of common warts.
That's, that's great. I want to ask on 315, but before I do that, I want to see if anyone in the audience has any questions on YCANTH.
Yeah, thanks so much for taking my question. I just wanted to see, you know, I remember-
... you know, coming into, you know, the approval of YCANTH and, you know, looking at the competitive landscape, there was always some debate around the, the berdazimer gel and, you know, the take-home therapy versus in-office use. I'm curious now that, you know, both respective, you know, franchises and programs have gotten their legs under them, you know, albeit early. I'm curious what the latest is on KOL, patient-physician feedback is on, you know, preference and, you know, real, real-world use case for both?
You know, great question. I think, you know, first and foremost, we think it's great that, you know, another player is coming into the space. I think that's just going to raise the noise level, which will ultimately help YCANTH. Again, as I mentioned, you know, YCANTH compared to being the gold standard for the treatment of molluscum. But you're really talking apples and oranges, because, you know, our products dose once every three weeks. There's no limit on the number of doses, but you know, typically we're seeing, you know, anywhere from two-four applications.
That product is obviously, you have to apply it every day for 84 straight days to every lesion, which we think is, you know, a big ask, the product has to be mixed together in order to activate the nitric oxide. And then finally, as I mentioned earlier, you know, what I always love about our opportunity is, you know, being a clinician-administered asset, there's a revenue a revenue opportunity for the physician, and so, that creates the partnership. With this particular product, there'll be no CPT code, there'll be no ASP plus model for those physicians, but it'll definitely have its place.
You said on the basal cell, give us a little more on that opportunity, and does it change your reach with derms at all?
So, great question. So, first, we're really excited about the opportunity that we have with basal cell. We think that there's a real need for a non-invasive procedure for basal cell because, look, no matter how good the Mohs surgeon is, especially if you're having a basal cell on your face, there's always some type of residual effect, and so people are really looking for alternatives. Some of the hedgehog inhibitors that are out there available, they have a lot of toxicity issues, a lot of side effect issues. So, you know, we think if 315 is effective, it could be a real alternative. It does not change our target base. It's still going to be the dermatologist.
The difference is now the dermatologist could potentially treat basal cell versus referring them out to a Mohs surgeon. Now, a lot of your dermatology group practices have Mohs surgeons, you know, included in the group practice, so it's all contained. In addition, you know, we did something, we went to the payers first on 315 to see what reimbursement would be like. So we kind of did things a little bit backwards, but we want to make sure that it would be dermatologists would be incentivized to treat. So what we found is same thing, CPT codes are available, the administration of the drug, so very similar to what we see with YCANTH for molluscum, we'll see for 315.
In some respects, doing it, as you call it, backwards, is probably the right way, right?
Yeah, exactly.
Starting with the end in mind.
That's right.
Phase II is underway, top line first half. Now, how should we be thinking about that, as you and Gary set up the expectations or what we should be looking for?
Yeah. So, you know, listen, the phase II study was primarily a safety study, tolerability study, dose escalation study. You know, we found the optimal dose. I think the way, you know, you should look at it as, you know, there'll be two things. We'll look at, you know, percentage of patients who had complete clearance and of their basal cell, and then we'll also look at for those patients that did not clear, what was the % of reduction in the basal cell?
Mm-hmm.
So that will tell us, you know, our next steps in the phase III program.
Okay. Fantastic. And then just to wrap up, just taking a step back as you're building a derm franchise and certainly the focus on YCANTH, on VP-315, how is this journey of going it alone, certainly with Torii, which is an external partner, but how do you think about strategically your assets, these indications, and other assets that you're looking at when it comes to partnerships and leverage from yourself, but also from external partners?
Yeah. So listen, I think that another great question. I think we're very open to partnerships.
Mm-hmm.
I think when you look at the disease states that we're in, they're all over the world. So it's not just exclusive to-
Mm-hmm
... you know, to certain regions. We're open to strategic partnerships and where it makes sense.
Great. And your latest cash position and the runway and where that's taking you?
Yeah. So we ended the quarter at $48.9 million, and we said that will take us into Q1 of 2025.
Great. Great. Well, I think maybe that's a good place to leave it. It's a lot going on at Verrica. We appreciate the time and look forward to the data for basal cell, but also the continued progress.
Great. Thanks for having us, Greg.
Thank you.
Thank you. Alright.