VRCA - NASDAQ

Good evening, ladies and gentlemen, and welcome to the Verrica Pharmaceuticals Second Quarter 2025 Corporate Update Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the call over to your host, Kevin Gardner of LifeSci Advisors. You may begin your conference.

Thank you, operator. Hello, everyone, and welcome to Verrica Pharmaceuticals Second Quarter 2025 Corporate Update Conference Call. With me on the line this evening are Jayson Rieger, President and Chief Executive Officer of Verrica Pharmaceuticals; Noah Rosenberg, Chief Medical Officer; John Kirby, Interim Chief Financial Officer; and David

Thank you, Kevin, and good evening, everyone, and thank you for joining us for our second quarter 2025 corporate update call. The second quarter featured a number of notable accomplishments across multiple areas of our business, each of which has made us stronger as a company. First and foremost, I'm very pleased with the continued execution from our commercial team, which continues to grow our YCANTH business and is now helping thousands of patients and their families treat molluscum contagiosum every month. On July 9, we reported a record 13,434 YCANTH dispensed applicator units in the second quarter, which represents sequential quarterly growth of 32.8% over the prior quarter. In a moment, I will describe in more detail our recent business experience and the tailwinds that are helping to drive this growth. We also made major progress in strengthening our relationship with Torii Pharmaceutical, our development partner for YCANTH in Japan. As we announced on July 1, at the end of the quarter, we executed an amendment to our agreement with Torii, whereby we secured Torii's financial commitment to starting our planned global Phase III program to study YCANTH in patients with common warts. And we also received an $8 million milestone payment from Torii shortly thereafter in July. I'll describe in greater detail later in the call the financial and strategic benefits stemming from the Torii amended agreement, which we view as a significant driver of value for our shareholders into the future. I'll also share a brief update on our development plans for VP-315, our other late- stage pipeline asset, which is ready for Phase III trials for the treatment of basal cell carcinoma. We believe this program has strong potential to drive future value for Verrica. Finally, John will take and provide a detailed review of our second quarter financials. I will now provide a more detailed update on our commercial activities for YCANTH. Our strong second quarter results once again reflected our focused commercialization strategy. Starting in the fourth quarter of 2024, we began to focus on those territories with high prevalence of molluscum and robust medical and pharmacy benefit coverage. As our strong sequential growth in the second quarter demonstrates, this more focused commercial strategy is resonating with health care professionals. We believe that these providers are experiencing positive outcomes for their patients, and we expect to continue to build these relationships across both pediatric and dermatology practices, driving continued expansion in YCANTH utilization. In addition, we continue to make substantial investments in our commercial co-pay assistance program, which allows patients with commercial insurance to pay just $25 per YCANTH treatment for up to 2 applicators, which provides physicians with comfort knowing that their patients will find affordable access for YCANTH. Our priority has been making YCANTH broadly available so that many health care professionals as possible can treat their patients. To this end, and because of that investment, we have seen an increase in utilization of the co-pay program during the second quarter, and we believe utilization of the co-pay program may continue to increase in future quarters as more prescribers use this important option to support their patients' treatment with YCANTH. Given our success in growing our core business over the last 2 quarters, we are now applying the same disciplined approach to expand into additional territories where demand and reimbursement for YCANTH is likely to be strong and sustainable. As noted on our first quarter call, we started recruiting sales representatives for these new territories, splitting territories covering certain large markets and entering into these new markets as well. Consistent with the first quarter, we have continued to add local independent regional pharmacies to our pharmacy distribution network, along with our national specialty pharmacy partners. Our approach to distribution of YCANTH continues to focus on making YCANTH available where health care professionals prefer to write their prescriptions, and we continue to see strong adoption with this approach. For the second consecutive quarter, YCANTH inventory remained at normalized levels with YCANTH applicator units shipped to distributors, continuing to closely track underlying market demand of dispensed applicators. In terms of commercial operating costs, as I mentioned earlier, we expect to selectively add sales personnel based on identifying additional high-value territories with our disciplined criteria. Looking ahead to the second half of 2025, we remain confident in generating strong and sustainable growth, primarily driven by YCANTH's unique set of product attributes. As an in-office treatment, health care professionals who choose YCANTH can directly observe the dosing compliance for their patients. We believe ensuring that patients complete the treatment cycle established by their physicians contributes to the clinical safety and efficacy profile of YCANTH. We believe in-office treatment provides -- gives providers a role in making sure patients are actively treated properly rather than just being seen in the office and prescribe a product to take home, as at-home treatments have historically shown only modest patient compliance in dermatology. In addition, our product provides an incremental revenue opportunity for pediatricians while maintaining historic billing models for dermatologists. In summary, we are very excited about the progress we have made so far this year. We believe YCANTH is a product with exceptional growth potential and will be the new standard of care available for the millions of patients impacted by molluscum contagiosum. Before providing an update on our pipeline, I would first like to touch upon our recently amended agreement with Torii Pharmaceutical which, as I mentioned, has significant benefits for our company. On July 1, we announced a second amendment to our existing collaboration and license agreement with Torii, securing Torii's commitment to launch with Verrica a global pivotal Phase III program for YCANTH for the treatment of common warts. As part of this amended agreement, we're able to finalize a path to receive up to $18 million in nondilutive capital in 2025, which includes an $8 million milestone payment already received from Torii earlier in July. If Torii obtains approval for molluscum contagiosum in Japan, which may occur by the end of 2025, this amended agreement provides that we would receive an additional milestone payment of $10 million in cash rather than as an offset to trial costs as previously contemplated. For our investors, it is important to put into proper context the tremendous benefits of this revised agreement. This deal enables us to strengthen our balance sheet without the need to issue a single share of new common stock. Of course, the arrangement with Torii also provides Verrica with critically important drivers of long-term value. Torii committed funding of $40 million for this global program. The $40 million is expected to cover around 90% of the program cost, and Verrica is committed to funding the remainder of the program. As you may recall, Verrica and Torii will split the cost 50-50 with Verrica having the ability to offset its 50% against future milestones, royalties and transfer payments. We plan to initiate a manufacturing transfer to Torii for YCANTH applicators to be sold in Japan, which is expected to take place in stages over the next few years. In the interim, we will continue to receive from Torii a transfer price for applicators manufactured by Verrica's manufacturing partners. After the transfer of at least one component of the manufacturing process, Verrica will begin receiving royalties related to net sales in Japan of applicators manufactured by Torii and/or its manufacturing partners. This commitment further allows Verrica to advance this critical development program in a nondilutive way. Torii's partnership provides us with the funding needed to see the global Phase III program to completion and provides us with a clear pathway to potentially seek the label expansion. Furthermore, we retain 100% ownership of the global rights to YCANTH for all indications in all territories outside of Japan. We believe that the preservation of these exclusive rights may have profoundly transformative implications for the future long-term value of our company. We are also working with Torii to launch the global Phase III program evaluating YCANTH for the treatment of common warts, and Verrica expects to dose the first patient in this global Phase III program in the United States in the fourth quarter of 2025. I'd also like to address our lending partner, OrbiMed. In mid-June, we disclosed an amendment to our credit agreement with OrbiMed, where they agreed to waive the going concern qualification to our financial statement for the remainder of 2025. OrbiMed continues to be a great partner to us throughout the implementation of our new commercial strategy for YCANTH, and we very much appreciate their continued support. I'll now provide a brief update on our clinical-stage programs. Based on Torii's NDA filing for molluscum in late 2024, we expect a regulatory decision on YCANTH-designated TO-208 in Japan by the end of the year. Over 1.6 million patients in Japan alone contract molluscum annually, which represents a significant market opportunity, and we look forward to Torii sharing updates on their regulatory approval process later this year. I would like now to turn to our program in basal cell carcinoma using our novel oncolytic peptide, VP-315. As you may recall, we have previously disclosed top line safety and efficacy data regarding histological clearance and objective response rates. In the second quarter, we also received final minutes from the FDA following a successful End of Phase 2 meeting. Following our End of Phase 2 meeting with the FDA, we now have additional clarity on advancing this unique and promising therapy into a pivotal Phase III program. We plan to explore opportunities to fund the basal cell program, which may include strategic nondilutive partnerships for financing both the development of the program as well as post-approval commercialization for this potential multibillion-dollar opportunity in the most common form of skin cancer. Planning activities are already underway, including engaging with potential clinical research organizations to manage the study, establishing a study budget and a time line and identifying potential study investigators. We plan to provide a comprehensive overview of the basal cell program, including an announcement of additional genomic and immune response data later this year at a scientific conference. I'll now turn the call over to our Interim Chief Financial Officer, John Kirby.

Thanks, Jayson. I'll now take a few minutes to summarize our financial results for the quarter ended June 30, 2025. For the second quarter of 2025, we reported total revenue of $12.7 million compared to total revenue of $5.2 million in the second quarter of 2024. Total revenue for the second quarter of 2025 primarily consists of $8 million of Torii milestone revenue and net YCANTH revenue of $4.5 million compared to no milestone revenue and $4.9 million of net YCANTH revenue in the second quarter of 2024. Net YCANTH revenue in the second quarter of 2025 reflects shipments to our distribution partners, offset by standard gross-to-net adjustments, including actual or anticipated product returns, off-invoice discounts, distribution fees, rebates and co-pay assistance programs. As a reminder, in the second quarter of 2024, approximately 54% of net YCANTH revenue represented a onetime impact of an initial stocking order from a new specialty distributor. This year, as Jayson mentioned earlier, net YCANTH revenue represents orders from our distribution partners to meet demand from their customers. Gross product margins for the second quarter of 2025 were approximately 93% and cost of product revenue was $0.3 million, with no material obsolete inventory costs. Research and development expenses of $1.8 million in the second quarter of 2025 decreased compared to the second quarter of 2024 by $1.5 million, driven by a $0.8 million decrease of clinical trial expenses primarily related to VP-315 as well as decreases in costs related to CMC and medical affairs expenses of $0.6 million. Selling, general and administrative expenses of $8.9 million in the second quarter of 2025 decreased compared to the second quarter of 2024 by $7.7 million, driven primarily by the implementation of our more focused commercial strategy for YCANTH, including a reduction in sales force of $5.7 million, decreased marketing and sponsorship costs of $1.1 million and decreased legal costs of $0.9 million. Before I discuss net income and net loss per share, I will note that on July 24, we effected a reverse stock split at a ratio of 1-for-10 shares of our common stock. As a result, every 10 shares of our issued and outstanding common stock were automatically combined into 1 share. The 2025 and 2024 per share amounts I will note reflect the impact of the reverse stock split. GAAP net income was $0.2 million or $0.02 per share for the second quarter of 2025 compared to a GAAP net loss of $17.2 million or $3.70 per share for the second quarter of 2024. On a non-GAAP basis, which excludes stock-based compensation, noncash interest expense and change in fair value of embedded derivatives, the second quarter of 2025 net income was $2.4 million or $0.25 per share compared to a net loss of $14.4 million or $3.11 per share for the second quarter of 2024. And finally, as of June 30, 2025, Verrica had aggregate cash and cash equivalents of $15.4 million. Under GAAP, the cash and cash equivalents as of June 30, 2025 would not be sufficient to fund operations for the 1 year period following the release of our financial statements. However, as Jayson mentioned earlier, under our recently amended collaboration and license agreement with Torii, we received an $8 million milestone payment in July. We are also eligible to receive a $10 million cash milestone payment from Torii for the Japanese approval of YCANTH, TO-208 in Japan for molluscum. The approval decision in Japan is expected to occur by the end of 2025. In addition, it is also possible that we could receive up to $25 million in proceeds from the exercise of Series A warrants issued as part of our November 2024 equity financing, which expire in November of 2025. Nonetheless, we will continue to apply discretion in our uses of cash and explore opportunities to further bolster the strength of our balance sheet, while still advancing our commercial and clinical efforts. I'll now turn the call back over to Jayson for closing remarks.

Thanks, John. Based on the performance for the first half of 2025, we believe it is increasingly evident that our more focused commercial strategy is helping to drive significant demand for YCANTH. This demand is being driven primarily by the unique attributes of our product, robust commercial and Medicaid insurance coverage and most importantly, the outstanding relationships that our commercial team continues to build in the medical community. Looking at the second half of the year, I believe we remain on track to realize strong and sustainable growth based on the significant momentum in our business. We expect our commercial team will continue to execute. And with our recently amended agreement with Torii, Verrica has also taken important steps to realize the long-term value in our late-stage pipeline. We are excited about the future of our company and significant value-creating opportunities that lie ahead for us as YCANTH utilization continues to expand and our clinical programs into pivotal testing. With that, we would now be happy to take your questions. Operator?

[Operator Instructions] We'll take our first question from Stacy Ku with TD Cowen.

Congrats on the quarter. So we have a few questions. First, now have been 2 quarters kind of discussing high level the expansion of the sales force. So could you provide more details how many additional, let's say, folks are you considering in the near term? And then for those areas of success, are you able to pinpoint what exactly is maybe the few reasons for increased YCANTH adoption? So that's the first question. The second question is compounded cantharidin, something that we haven't asked about recently. So just kind of curious with the sales force that's really now reacquainting themselves with YCANTH and the prescribers, what are they experiencing currently in terms of maybe the feedback you're hearing there? And then last question is on consensus, which has now increased to between $15 million to $20 million, so a touch above the $15 million from before. So curious what are your views? And of course, as a housekeeping -- for housekeeping purposes, maybe provide some additional color around the specialty distributor. Is that going to result in any lumpiness between quarters?

Well, thanks, Stacy. This is Jayson. I appreciate all the questions. Keep me honest if I leave any of them out and don't answer them fully. In terms of the sales reps, we were around 35 late last year and into the beginning of this year, and we expect that number to stay within that range to maybe 5 or 10 more in the short-term predictable future. I think that gives us robust coverage across the country, and we also buttress that with some inside sales and other support sales mechanisms. In terms of what's driving success, I think there's a lot of factors there. One, just the pure tenacity of our sales reps being out there calling on doctors every day and advocating the support for YCANTH, but that's coupled by strong support in the medical community on the clinical and safety benefits and efficacy benefits of YCANTH for patients. We worked very hard to improve access to YCANTH, both through the buy-and-bill mechanism where the company focused initially on the launch, but also through our expanding pharmacy network where patients can access the drug; b, a doctor writing a script to the pharmacy and that pharmacy couriering under a white bag service right back to the doctor. So that goes into the normal pharmacy benefit. Commercial patients only pay up to $25 for 2 applicators and the drug is there for their treatment. So that's been a very big advantage. A lot of these doctors, particularly dermatologists, have preferred local pharmacies that they've worked with historically and provide great customer service, and that provides very rapid access to the drug for treatment of their patients. In terms of compounded cantharidin, as we've said in the past, it is on the book drugs list. It is available and clinicians can access it. We've seen a significant change in that utilization. We still do find it on-site from time to time, but it is allowed to be used for common warts and other indications. But we've seen a larger adoption of the use of compounded cantharidin only for that indication and much more use of YCANTH for molluscum. We continue to simply advocate for the value proposition of YCANTH for the patients and the clinicians that are treating them. In terms of consensus, I appreciate you always asking for forward-looking guidance. I know that $15 million to $20 million is sort of where the analysts seem to be, as you indicated. I think our goal is to continue to execute quarter-over-quarter in growing the number of applicators dispensed on our underlying revenue. So at this point, we continue to grow, continue to push and make that happen, and we'll see where the next rest of the year comes from.

And we'll next go to Serge Belanger with Needham & Company.

This is John on for Serge today. Congrats on the continued progress. So you reported another solid quarter of growth in dispensed applicator units, 17% in Q1 and now 33% in Q2. So since we're still in peak season here for molluscum, I just wanted to gauge if we should expect similar growth for Q3 or more of a less pronounced growth trajectory just based on seasonality trends? And then second, regarding patient access. I believe you've previously mentioned the majority of pediatrics are covered under Medicaid. Just curious how progress is going there? And any updates on the derm side, particularly pertaining to improvements in commercial coverage?

Thank you. So in terms of general guidance, we don't really give that. What we can say is molluscum seems to be a disease that exists year round. It's often diagnosed as a secondary diagnosis when a parent is at a pediatrician and asks for what is the spot of my child, and we're trying to capture and encourage that treatment rather than a watch-and-wait mentality. And we're seeing adoption of that approach, both by pediatricians and by dermatologists. We are seeing an uptick in the number of pediatricians and the number of [ dermatologists ] both who treat molluscum with YCANTH. So we're seeing that trend continue. In terms of just the general accessibility of the drug, I think that's where the growth is going to continue to come. As it's easier for clinicians to gain access to the product and the coverage continues to expand, that will continue to help. Every quarter, we seem to get greater access on either Medicaid or commercial access to YCANTH across the country as we build robust coverage both on the medical and the pharmacy side. So every quarter, we seem to get greater coverage in one of those sort of 4 categories, and we continue to use that as a driving factor for bringing on and expanding our sales force and our commercialization efforts.

[Operator Instructions] We'll go next to Kemp Dolliver with Brookline Capital.

A couple of questions on the receivables and then GTN. The receivables had a pretty sharp increase quarter-to-quarter. Can you comment on the drivers of that because they looked like they were in excess of the growth in revenue sequentially? And then also, what are you seeing with GTN, particularly with the increased use of the $25 co-pay program?

Kemp, this is John. Thanks for your question. So remember that our collection terms are 60 days. So if you think about it, things that were sold in the second and third month of the quarter are being collected in the first and second month of the following quarter. So that gives rise to part of the increase. Also from the -- your second question, which...

Gross to net.

Gross to net, sorry. So you can -- our WACC is out there. You can get a rough estimate from the dispensed applicator units, which we are disclosing or have disclosed for the second quarter and the first quarter. As Jayson noted in his comments during the beginning of the call, right, we do have -- we have been trying to get the product out there and get the patients treated and the co-pay card has been used. So that may lead to slightly different gross to nets in the future, but we haven't given direct guidance on the gross to nets. Also, just to -- sorry, to come back to your first question, just to confirm, my comments were around the commercial receivables. The $8 million Torii receivable was included in a separate line item on the balance sheet, but that was another $8 million in receivable. But obviously, that's a unique item, shall we say.

Right and higher quality. And then just to clarify on the GTN, have you changed WACC since launch?

We have not.

And that does conclude today's question-and-answer session. I would now like to turn the call back over to Jayson Rieger for final and closing remarks.

Thank you, operator. I'd just like to thank everyone for joining the call this evening, and we look forward to providing updates on our progress throughout 2025. Have a great evening.