Verrica Pharmaceuticals Q4 2024 Earnings Call Transcript

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March 11, 2025

There are 8 speakers on the call.

Operator

evening, ladies and gentlemen, and welcome to the Verica Pharmaceuticals Fourth Quarter and Full Year twenty twenty four Corporate Update Conference Call. At this time, all participants are in a listen only mode. After the speakers' remarks, there will be a question and answer session. As a reminder, this conference is being recorded. I would now like to turn the call over to your host, John Francis of LifeSci Advisors.

Operator

You may begin your conference.

Speaker 1

Thank you, operator. Hello, everyone, and welcome to Verica Pharmaceuticals' fourth quarter and full year twenty twenty four corporate update conference call. With me on the line this evening are Jason Reager, President and Chief Executive Officer of Verica Pharmaceuticals John Kirby, Interim Chief Financial Officer David Zowetz, Chief Operating Officer Chris Hayes, Verica's Chief Legal Officer and Aaron Hullitt, Chief of Commercial. As a reminder, during today's call, management will make forward looking statements. These statements may include expectations related to the commercialization of WiCAM, the treatment of molluscum contagiosome in The United States, regulatory developments, the development of Verica's product candidates, the company's expected cash runway and its ability to obtain funding for future operations and Verica's overall business strategy and planned operations.

Speaker 1

These forward looking statements are based on the company's current expectations and involve inherent risks and uncertainties. And based on those risks and uncertainties, Verica's actual results and the timing of events could differ materially from those anticipated in such forward looking statements. Please see Vareka's SEC filings for important risk factors. Vareka cautions you not to place undue reliance on forward looking statements and undertakes no duty or obligation to update any forward looking statements as a result of new information, future events or changes in expectations. In addition, during today's call, management will discuss certain non GAAP financial measures.

Speaker 1

These non GAAP financial measures are in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with GAAP. There are a number of limitations related to the use of these non GAAP financial measures versus their closest GAAP equivalents. The earnings release that the company issued today includes GAAP to non GAAP reconciliations for these measures and is also available on the Investor Relations section of Verica's website. I'll now turn the call over to Verica's President and CEO, Jason Reager.

Speaker 2

Thank you, John. Good evening, everyone, and thank you for joining us for our fourth quarter and full year twenty twenty four corporate update call. As most of you are aware, in the fourth quarter of twenty twenty four, we began a transition period at Verica, including a significant change to our commercial organization, a leadership transition and a significant capital raise in November. We are executing on our turnaround plan with a more focused commercialization strategy for Y Camp, while substantially reducing costs across the organization. In a few moments, I'll describe in more detail the progress we have made and continue to make on this plan and why I believe we are now on a trajectory towards sustainability in the company with a clear focus on maximizing YCAMP utilization for for the treatment of musculoskeletal and advancing our late stage pipeline programs.

Speaker 2

We continue to support our development partner, Tori Pharmaceutical, in their effort to obtain approval from Japanese regulators for TO-two zero eight referred to as Wycanth in The United States and we were happy to see their filing of a new drug application in Japan for TO-two zero eight during the fourth quarter of twenty twenty four. We are also excited to continue to work with Linix BioPharma in advancing our basal cell carcinoma asset BP315. At our update at the end of Q3 last fall, we indicated a belief that it could be into the first quarter of this year before we saw business stabilization and the signs of working through channel inventory. I am pleased to report that we have already seen new purchases from our distributors in the fourth quarter to replace depleted inventory levels ahead of what we had previously anticipated. We look forward to updating you with more details regarding Q1 twenty twenty five dispense units in the near future.

Speaker 2

We are making significant progress in advancing our clinical stage pipeline, which includes pursuing YCAM for common warts as an additional indication as well as our novel on clinic peptide BP315 for the treatment of basal cell carcinoma. Each of these programs represent potential key value drivers for our company and in my view remain underappreciated assets given each program's potential to become first in class treatments in two large dermatological conditions with significant unmet medical need. We are in a unique development position where we believe we will be able to advance our common war program through Phase three in collaboration with Tori and also achieve key data and regulatory feedback for our basal cell program with minimal additional cash outlay for VERICA. We also made significant progress with respect to our financial position raising approximately $42,000,000 in an equity follow on offering in November and subsequent to the end of the quarter obtaining a waiver of going concern covenant for the quarter and year ended 12/31/2024 and the first quarter of twenty twenty five from our lending partner, Orbimed. I will now provide an update on our commercial activities for Wycanth and related results from the quarter.

Speaker 2

In November, we announced a new commercialization strategy focused on driving demand for Wycanth in territories with high prevalence of molluscum and established strong insurance coverage for Wycamp. This focus was also intended to make Verica become a leaner and more efficient company in the process. I am pleased to say that over the last several months that is exactly what has happened. As announced in our business update in December, we've reduced our operating expense burn rate by approximately 50%, while not only maintaining our prior sales levels, but also achieving positive growth in dispense applicator units in the fourth quarter compared to the prior quarter. Our sales representatives have substantially increased their productivity measured as an average of sales per selling day and we are now seeing the results of their efforts.

Speaker 2

Our fourth quarter operating results do reflect the beginning of this success and we expect to see further reflection of this strategy in the results for the first quarter of twenty twenty five and beyond. In the fourth quarter, we reported Wycan't dispense applicator units of 8,654 versus the prior quarter units of 7,706, which represents sequential quarterly growth of 12.3%. And when compared to the second quarter of twenty twenty four of 5,975 units, the Wyckham Applicator unit growth increased by 44.8%. Another important dimension of our commercial realignment was to make it easier for physicians to order and acquire YCAMs on a buy and bill basis. We therefore introduced a new single applicator configuration for YCAM or the one count, which became commercially available this quarter.

Speaker 2

We believe the one count will reduce acquisition costs from for physician practices in certain channels and potentially expand distribution and patient access to Y Camp. Furthermore, we have made great strides in increasing access to the pharmacy benefit route by adding local specialty pharmacies to our strong relationship with NuFactor, our nationwide specialty pharmacy. With respect to Wycanth inventory, we believe we have now fully reserved for distributor inventory reasonably expected to be returned to a lower than anticipated pull through and observed a significant reduction in distributor inventory levels from our active distributors exiting the fourth quarter. Based on our latest data, we believe that inventory has now reached a stable normalized level where demand for Wycanf Applicator units will translate into new demand driven revenue regularly going into or going forward into 2025. I'd now like to discuss our plans to develop Wycanf in the treatment of common warts.

Speaker 2

Recall that earlier last year, we amended our licensing agreement with our development and commercialization partner Torrey Pharmaceutical, which enabled us to equally split the cost of a new planned global Phase three clinical program in common warts. Tori previously agreed to fund Verica's portion of the cost as an offset to Tori's future payment obligations to Verica for meeting regulatory milestones and royalties, the sales of Wycamp for molluscum contagiosum and common warts in Japan. As we noted in December, Torrey filed a new drug application in Japan seeking approval of Wycamp called TO-two zero eight in Japan for the treatment of molluscum and we look forward to helping Torrey reach an estimated one point six million molluscum patients in Japan after they obtain regulatory approval. Furthermore, Tori will make a milestone payment of $8,000,000 to VIRICA upon initiation of a Phase three clinical trial with initiation of a global program potentially starting as early as mid-twenty twenty five. Considering the fact that there are approximately 22,000,000 patients in The U.

Speaker 2

S. Alone with common warts and no FDA approved therapies, this makes common warts the single largest unmet need in all of dermatology. Under our amended funding structure, Tory, the capital required for Vericut to fund this large Phase three program is expected to have almost no impact on our cash position, which in my view is fairly remarkable considering that this is a global registrational trial where we will still retain 100% of commercial rights to WiCAMP in The U. S. And elsewhere around the world other than Japan.

Speaker 2

I'd now like to focus the recent progress we have made in advancing our late stage clinical oncology asset BP315. In October 2024, we presented two posters at the twenty twenty four Fall Clinical Dermatology Conference featuring positive preliminary top line results of VP315 for treatment of basal cell carcinoma. The posters include safety and histologic clearance data from eighty two patients with up to two target basal cell carcinoma tumors in Part II of the Phase II study. As a reminder, Part II of the Phase II study was designed to explore dosing regimens to help us identify the recommended regimen for a Phase III study program. As we identified eight milligrams as the optimal dose in Part one of the study.

Speaker 2

Preliminary top line results showed that approximately fifty one percent of tumors treated with VP315 achieved complete histological clearance. For those patients with a residual tumor achieved on average approximately seventy one percent reduction in tumor size. BP315 was well tolerated. No treatment related serious events were reported in the study and most treatment related adverse events from mild to moderate. Most recently, we presented the results from a post hoc analysis of the data from Part two of the study at the twenty twenty five Winter Clinical Dermatology Conference, which demonstrate that treatment of with VP315 led to a calculated objective response rate or ORR of ninety seven percent, which is defined as the percentage of study subjects who do not demonstrate disease progression and who experienced at least thirty percent reduction in tumor size along with partial or complete response following treatment.

Speaker 2

This is quite a compelling observation as it suggests that nearly every subject of the study obtained benefit from BP315 treatment. We still expect to report genomic and immune response data from this trial in the coming months and to receive minutes from an end of Phase two meeting in the first half of twenty twenty five, which will be critical for gaining alignment for the advancement of the program into Phase three trials. We are highly encouraged by these positive preliminary top line results, which we believe demonstrate the potential for VP315 to change treatment paradigm for patients with basal cell carcinoma, the most common form of skin cancer. Over the last several months, I've had the opportunity to speak with many investors about Verica and without a question, I believe our common warts program and basal cell carcinoid programs are two significantly underappreciated assets. To that end, we will continue to provide updates on the progress of these pipeline programs, while the majority of the organization remains laser focused on the YCAM for molluscum commercial efforts.

Speaker 2

I'll now turn the call over to our Interim Chief Financial Officer, John Kirby, to discuss our recent financing activities and to review our fourth quarter and full year 2024 financials.

Speaker 3

Thanks, Jason. I'd like to start by covering our recent financing activities, which have enabled us to strengthen our balance sheet. In November, we raised $42,000,000 in a public offering of common stock, pre funded warrants and accompanying Series A and B warrants. As you will recall, in July 2023, Verica entered into a debt financing with OrbiMed and upon closing of the agreement, we borrowed $50,000,000 from the facility. In February of this year, we negotiated with OrbiMed a waiver of certain covenants under our credit agreement, including the requirement that there be no going concern qualification with respect to the financial statements for the period ended 12/31/2024 and 03/31/2025.

Speaker 3

Turning to the financial results, for the fourth quarter and full year of 2024, we reported total revenues of $300,000 which was substantially all Wycanth revenue. Net Wycanth revenue reflects shipments to our distributor partners offset by standard gross to net adjustments, including actual or anticipated product returns, off invoice discounts and distribution fees and expenses. For the full year 2024, we reported total revenue of $7,600,000 versus $5,100,000 in the prior year. Total revenue for 2024 included net product revenue of $6,600,000 versus net product revenue of $4,700,000 in the prior year. As a reminder, Wycanth became available for commercial sale and shipment to patients in August of twenty twenty three.

Speaker 3

And so we did not recognize any product revenue prior to that point. Collaboration revenues of $29,000 in the fourth quarter of twenty twenty four related to our supply of applicators to Tory in connection with their development and commercialization activities. For the full year 2024 collaboration revenue was $1,000,000 compared to $500,000 for the year ended 12/31/2023. Similarly to the fourth quarter collaboration revenue for the full year 2024 and 2023 was related to supplies and development activity provided to Tory as needed support to the clinical supply agreement. Gross product margins for the full year 2024 were 72%.

Speaker 3

Cost of product revenue of $1,900,000 included $900,000 of obsolete inventory costs. Research and development expenses of $1,200,000 in the fourth quarter of twenty twenty four decreased versus the fourth quarter of twenty twenty three by $4,200,000 primarily driven by a $2,100,000 decrease of clinical trial costs related to VP315 as well as costs related to increased headcount of $1,200,000 and a decrease in regulatory costs of $700,000 For the full year 2024, research and development expenses were $11,800,000 compared to $20,300,000 for the year ended 12/31/2023. The decrease of $8,500,000 was primarily attributable to reductions of costs related to WiCan preapproval activity of $3,800,000 and decreased clinical costs for VP315 of $3,100,000 Selling, general and administrative expenses of $10,000,000 in the fourth quarter of twenty twenty four decreased versus the fourth quarter of twenty twenty three by $6,800,000 reflecting our commercial realignment activity and realization of cost savings. For the full year 2024, selling, general and administrative expenses were $58,800,000 compared to $47,300,000 for the year ended 12/31/2023. The increase of $11,500,000 was primarily a result of higher expenses related to commercial activities for Wycanth for the treatment of molluscum, including increased compensation, recruiting fees, benefits and travel due to ramp up of sales force of $8,500,000 as well as increased commercial related costs of $5,100,000 GAAP net loss was $16,200,000 or $0.24 per share for the fourth quarter of twenty twenty four compared to a GAAP net loss of $24,600,000 or $0.53 per share for the fourth quarter of twenty twenty three.

Speaker 3

GAAP net loss was $76,800,000 or $1.48 per share for the full year 2024 compared to a GAAP net loss of $67,000,000 or $1.48 per share for the prior year. On a non GAAP basis, which excludes stock based compensation, non cash interest expense and change in fair value of embedded derivatives for the full year 2024, net loss was $64,600,000 or $1.25 per share compared to a net loss of $51,800,000 or $1.14 per share in the full year 2023. And finally, as of 12/31/2024, Erika had aggregate cash and cash equivalents of $46,300,000 Under GAAP, the cash and cash equivalents as of 12/31/2024 would not be sufficient to fund operations for the one year period following the release of our financial statements. However, should Vareka receive the $8,000,000 milestone payment from Tori triggered by the initiation of the Phase three clinical trial in Japan for common warts or receive a portion of the $25,000,000 in proceeds from the exercise of Series A warrants issued as part of our November 2024 equity financing, which expire in November of twenty twenty five, we could have sufficient cash to fund our operations for such period. Nonetheless, we will continue to prudently use our cash and explore opportunities to further bolster the strength of our balance sheet.

Speaker 3

Before turning the call back over to Jason, I'd like to provide some additional details, which relate to partitioning of our debt into current and long term liabilities and the increase in valuation of embedded derivatives related to our OrbiMed agreement. Verrica did not meet thresholds specified in the OrbiMed debt agreement as of 12/31/2024, thus triggering the initiation of principal payments beginning in 2025. As principal payments have begun in 2025, America was required to reclassify the debt balance previously classified as all long term debt to have both a current and long term component on the balance sheet. Finally, I'd like to address embedded derivatives in the structure of the OrbiMed debt facility and its impact of their valuation on our financials. Since inception of this debt, the repayment of the debt prior to the balloon payment was deemed to not be probable and therefore the derivatives were valued at zero.

Speaker 3

However, since we are now required to make monthly principal repayments, the embedded derivatives, which include the exit fee and repayment fee were deemed to have value. For the fourth quarter, the change in fair value of the embedded derivatives resulted in a non cash expense of $2,600,000 in our statement of operations. I'll now turn the call back to Jason for closing remarks.

Speaker 2

Thanks, John. Although I arrived at Verica just a few months ago, I can tell you that we have made an extraordinary amount of progress over a very short period of time. We are faithfully executing on our new strategic initiatives across every area of our company and I believe we are now on a pathway towards strong and sustainable growth for Y Camp and our development programs. We have cut non essential spending as we execute on our strategy. Core to our commercial strategy is an emphasis on fostering an environment that will lead to more solid long term relationships with the physicians and the patients that we serve.

Speaker 2

As I mentioned earlier, we are also excited about the outstanding progress we are making in our clinical stage pipeline. As these programs continue to advance, we believe investors will see the massive potential of these programs, each of which could become the new standard of care in their respective indications. In summary, the Verica team has executed with a true sense of purpose and urgency in a few short months since I joined in November. As a commercial stage company with robust pipeline, we are excited about the future of Verica. We are seeing the fruits of the efforts over the last few months take hold as reflected by increased ease of access to YCAM by HCPs, increased dispensed units, reduction in channel inventory and advancement of our pipeline programs all at a pace ahead of our initial thoughts late last year.

Speaker 2

In Wycanth, we not only have a commercial product for the treatment of molluscum that is already back on a positive growth trajectory, but we also are uniquely positioned to address the largest and most underserved population in all of dermatology in common warts, as well as perhaps change the paradigm in which HCPs treat basal cell carcinoma through BP315. I would like to thank all of my VARECA teammates, both in the field and in our corporate organization. Going through a turnaround is difficult and requires substantial additional efforts to properly execute and the way that I am seeing our team respond to tough situations has strengthened my resolve that we can be successful and achieve positive outcomes for our physician customers and their patients. We believe we will emerge from this transition as a much stronger and capable team when working in close alignment to ensure that Verica achieves its potential and becomes one of the most innovative high growth companies in dermatology drug development. With that, we'd be now happy to take your questions.

Speaker 2

Operator?

Operator

Thank We will move first to Stacy Ku with TD Cowen.

Speaker 4

Hey, thanks so much for taking our questions and congratulations on the progress. So maybe a first question around maybe that patient demand. You talked about the applicators that are dispensed, but are you getting a sense around the number of patients roughly that are being treated with WiKan maybe from average dosing? Maybe talk about the feedback that you're getting from clinicians about whether or not it's now getting a little bit easier to access WiKan, whether they're able to kind of get that infrastructure that you're trying to improve. So that's the first question.

Speaker 4

And then obviously in the second the second question is looking to 25. Can you comment what you're seeing early in the year in terms of why can't adoption now that we're in March? Understand that you're trying to stay high level, but how is the new single applicator doing? How is broadening into pediatricians? Any type of maybe high level commentary about early twenty five would be appreciated as you're trying to kind of change the strategy.

Speaker 4

And then maybe the last comment is going to be around your expectations on sales for '25. Consensus is around $15,000,000 So maybe discuss your thoughts on where sell side is versus some of the sales force investment and potential R and D investment as it relates to your guidance to be cash positive monthly operating results by year end? Thank you so much.

Speaker 2

Thank you, Stacy. This is Jason. I appreciate all those questions. I'll try and tackle them in order. If I leave something out, please feel free to follow-up.

Speaker 2

In general, we're seeing very good adoption and interest in the use of Lycan for the treatment of molluscum both across the pediatrician market, but also our core dermatology market as well. The patients you are seeking the dermatologists and the pediatricians and are getting treated. Obviously, we published our clinical results and the efficacy and safety of YCAMP has been disclosed and has been well accepted by the medical professionals and we're seeing in the continued use of the product. Depending on the pediatrician or the dermatologist, you will see them using obviously several applicators or sometimes one depending on the need of that patient. We still encourage treatment to clearance as we did in our clinical study and as the FDA helped us in designing that program.

Speaker 2

The mixture of those treating with Wycamp continues to be a blend of all healthcare providers as we continue to roll out the program. In terms of 2025, I think we're continuing to see good momentum that we saw going into the end of last year. As we discussed in the past, we expected this to be a turnaround and would take into the first quarter to realize. And we're starting to see that traction even ahead of our original schedule. We're still being cautiously optimistic, but remain optimistic and confident we'll continue to see growth in the business.

Speaker 2

And that we're wrapping up the quarter and we'll be disclosing updates on that obviously in the next few months as the quarter comes to a close. In terms of guidance and consensus, at this point, we're going to just leave guidance where the analysts have left it so far. And as we gain momentum in the year and have better clarity on that, we may have further conversations. But at this point, our policy is not to provide revenue guidance.

Speaker 4

Okay. Incredibly helpful. Thank you.

Speaker 2

Thank you, Stacy.

Operator

We'll go next to Gregory Renzo with RBC Capital Markets.

Speaker 5

Great. Hey, good afternoon, Jason and team. Congrats on the progress scheduled. Thanks for taking my question. Jason, maybe just building on your commentary as you're focusing the field force and your efforts and as you've really geared towards that demand generation.

Speaker 5

I'm just curious if you could comment on maybe some of those seasonal tailwinds or even some sort of the periodic headwinds that can occur throughout a year as certainly we enter the warmer months, the spring and the summer. Do you have any views on what you're hearing as far as potential lifts or momentum that you could get as it converges with the demand generation you're working on? Thanks so much.

Speaker 2

No problem. So I would say that we were we've been establishing this business to be poised for both changes in seasonality if they are to occur. Often there is commentary that as the weather warms up and kids are more active outside that could continue to support the growth. And we're building our sales force and our team to be prepared for both the seasonality should it occur going into the second quarter and third quarter beyond this year as the weather warms up. Fortunately, it's beautiful weather out today.

Speaker 2

I think spring is rapidly approaching and we'll see that. Obviously, there was some rough winter weather this year and we've been very, very optimistic by what we've seen so far given the weather, the time of year, the deductible season etcetera. And so we remain cautiously optimistic about what this quarter and the upcoming quarters will look like.

Speaker 5

That's helpful. And maybe just a longer term question, maybe just remind us of how you're framing up the barriers to generic entry, the ultimate IP protection that you see with respect to WiCann?

Speaker 2

We actually have a very robust IP portfolio that takes us well into the future. And in terms of generics, obviously that's a long way off. Historically, the compounders have been the predominant concern and we're working through both any challenges from them, but also just going to where the market is and we're finding good adoption to our product. They have historically removed the 503B compounders from the market predominantly from Canada. That settlement was announced last year and we're moving forward with our program and finding good adoption.

Speaker 5

Thanks again. I'll hop back in the queue.

Speaker 6

Thanks, Greg.

Operator

We'll go next to Serge Belanger with Needham and Company.

Speaker 6

This is John on for Serge today. Thanks for taking our questions. So first on Wycanth, you've previously spoken on looking to expand usage beyond dermatologists and into the pediatric setting. Just wanted to gauge what sort of impact you've had on this front thus far and what you aim to achieve in terms of distribution between pediatrics and dermatologists in the future?

Speaker 2

So to that front, I would say that we are focusing on where the patients are going and we've seen a growth in the pediatric market. The product did start in the derms and I would say the derms have been a customer base that's both been loyal to us and we continue to both focus on and support. And we have found in some cases our pediatric derms, other derms have worked with us to expand access to their pediatric colleagues in the same community. At this moment, I would say the majority of our customers are still dermatologists who see the patients, but we're seeing a very large growing percentage of the pediatric the pediatricians treating with YCAM. So I would expect over time that mix is probably going to waffle back and forth between sixtyforty, fortysixty depending on how this product rolls out.

Speaker 2

But we're rapidly approaching sort of that equilibrium now.

Speaker 6

Okay. That's great. Thank you. And real quick on the VPE315, obviously, we'll see some additional data and FDA minutes in the first half here. But considering your new cost structure, I was just curious what your plans are in terms of timing to move this program into Phase

Speaker 2

3s? Yes. So as we were as we indicated before, we're very fortunate that all of the majority of the expense for that program was spent in the prior year and remaining data that's being collected in the regulatory interactions are de minimis in cost. Once we have that data in hand and that full package, we'll evaluate the program. It will also help us determine what the cost of that development program might look like.

Speaker 2

And we can then explore the best way to advance the program with all options available to us. The company does currently own the full rights to the program. So we have lots of opportunity for developing and advancing it and we'll make a disclosure on what we may or may what we may do to advance it once we have definitive FDA feedback and can confirm on what our development plan looks like.

Speaker 6

Great. Thank you.

Operator

We'll go next to Kent Oliver with Brookline Capital Markets.

Speaker 7

Great. Thanks. You're seeing a sequential uptick in demand for applicators and continuing to make some progress. What do you think you need to do to achieve, I think you've described as a hockey stick improvement in demand at some point?

Speaker 2

Sure. So I think growth in any business requires two things, acquisition of new customers as well as continued use utilization and growth of existing customers. Fortunately, we're seeing both in this business as we've done the turnaround and are moving forward. Our sales reps are very, very active in the field in dealing with customer needs. Our reimbursement teams are there to help.

Speaker 2

We have an expanded access through telesales to cover white space and additional support. And ultimately, it's going to require advancing into larger markets. And so we have historically worked with and are engaging with some of the larger practices, both that exist in the pediatric and the dermatology community, as well as expanding with the independent pharmacies and our pharma distribution partner NuFactor. I think those are ways we can provide product in a scalable way to customers and start seeing extra reach. So I think that's one of those are some of the key areas we'll see expansion and growth in the market.

Speaker 7

Thank you.

Operator

It appears we have no further questions at this time. I will turn the conference back to Mr. Reagor for any additional or closing comments.

Speaker 2

Thank you, operator. I'd like to thank you all for joining this evening and we look forward to providing updates on our progress throughout 2025. Thank you very much.

Operator

Thank you. Ladies and gentlemen, that will conclude today's call. We thank you for your participation. You may disconnect at this time.

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