Ladies and gentlemen, good morning, and welcome to the Pelthos Therapeutics 2026 first quarter financial results conference call. At this time, all participants are in listen-only mode. A brief question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please signal the operator by pressing star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mike Moyer, from LifeSci Advisors. Please go ahead.
Good morning, everyone, and welcome to the Pelthos Therapeutics 2026 first quarter financial results conference call. Pelthos issued a press release today announcing its financial results for the quarter ended March 31st, 2026. A copy can be found in the investor relations tab on the corporate website www.pelthos.com. Before we begin, I'd like to remind you that during today's call, statements about the company's future expectations, projections, plans, and prospects are forward-looking statements. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees and involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance, or achievements to be materially different from our current expectations expressed or implied by the forward-looking statements. Any such forward-looking statements represent management's estimates as of the date of this conference call.
While the company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. As a reminder, this conference call is being recorded and will remain available for 90 days. I'd now like to turn the floor over to Scott Plesha, Chief Executive Officer. Sir, you may begin.
Thank you, Mike. Good morning, everyone. We're delighted to be with you today and to share with you our first quarter 2026 operating results and highlights. Joining me today are John Gay, our Chief Financial Officer, and Sai Rangarao, our Chief Commercial Officer. The first quarter of 2026 was a successful one for Pelthos with strong execution and progress made in several key areas that I'll share at a high level with you. First, we experienced substantial revenue growth driven by increased prescriptions of our lead product, ZELSUVMI, during its third quarter since its launch. Next, we completed the expansion and optimization of our sales force from 50 sales representatives to 64. We believe that the expansion of our sales force and the contract we executed with a major pharmacy benefit manager in December 2025 have been important catalysts in demand for ZELSUVMI since January.
Within this PBM, unit dispense have doubled, and the number of prescribers has increased 121%. Finally, we continue to make progress in establishing the manufacturing of our two other highly complementary products, Xepi and Xeglyze. John and Sai will provide a more detailed look at the quarter's ZELSUVMI launch metrics and reported financial results, but I'd like to share a brief overview of results of operations. Our top-line results were driven by a 25% increase in prescription units as reported by Symphony Health, which increased from 6,312 units in the fourth quarter of 2025 to 7,884 units in the first quarter of 2026.
This drove an increase in net product revenue from $9.1 million during the fourth quarter of 2025 to $10.7 million in the first quarter of 2026. Importantly, we achieved this growth with only a minimal increase in wholesaler inventory while reducing the days on hand by more than one week from the end of Q4 2025 to the end of Q1 2026. As a reminder, ZELSUVMI is a novel topical nitric oxide-releasing product indicated for the treatment of molluscum contagiosum or MC in patients one year of age and older for up to 12 weeks. ZELSUVMI is an important advancement in the treatment of MC as it's the first and only FDA-approved therapy that can be applied by parents, patients, or caregivers in the home or on the go.
We believe the opportunity to treat MC at home and without the need for an in-office procedure has been and will continue to be a key driver of ZELSUVMI demand. We are pleased with the growth delivered in Q1 and are confident we can build on our momentum as units dispensed during April 2026 increased to 3,776 from 3,309 units in March 2026, a 14.1% month-to-month increase. Regarding Xepi and Xeglyze. Xepi is a novel FDA-approved topical treatment for impetigo that addresses a critical unmet need in antibiotic-resistant skin infections caused by staph and strep infections, most commonly affecting children. Impetigo is the most common skin infection in children seen by pediatricians with approximately nine million patients diagnosed with this bacterial infection each year.
We believe Xepi is a highly complementary product as it mostly treats children that are managed by the same healthcare providers as ZELSUVMI. Importantly, this allows us to leverage our commercial infrastructure, including our expanded sales force. We continue to focus on establishing the manufacturing process and building launch inventory. Expect to launch Xepi in early 2027. With respect to Xeglyze. Xeglyze is a novel FDA-approved product that is highly complementary to ZELSUVMI and Xepi and is expected to require minimal incremental overhead to commercialize. At the operational level, we are standing up manufacturing for Xeglyze and expect to bring it to market in mid-2027.
Both Xepi and Xeglyze will have meaningful call overlap for existing sales force, providing the company with greater operational and financial leverage from our existing team and infrastructure. Supporting our continued launch execution of ZELSUVMI and the launch preparation of Xepi and Xeglyze, we closed a $50 million term debt loan in January 2026, of which we drew $30 million. This additional capital strengthens our balance sheet and together with expected revenue growth, supports our current business plan.
In summary, we are pleased with the strong response from healthcare professionals to ZELSUVMI, as demonstrated by the more than 20,000 units dispensed since its launch in July of 2025. We continue to plan for the upcoming launches of Xepi and Xeglyze, two complementary FDA-approved products. We'll continue to evaluate and optimize our commercial strategy to drive sustainable long-term shareholder value. I'll now turn it over to Sai to provide more specifics on the results of the ZELSUVMI launch and key performance indicators. Sai Rangarao?
Thank you, Scott. Good morning, everyone. I'm pleased to provide an update on our Q1 2026 ZELSUVMI performance. Our progress to date continues to deliver better than expected results in just our third quarter since launch. For Q1 2026, shipments and prescriptions were ahead of expectations. On the qualitative side, we continue to receive very positive feedback from HCPs, patients, and caregivers on the ease of use and efficacy of ZELSUVMI. Getting into prescription details, the number of prescriptions rose a very strong 25% from 6,312 in Q4 2025 to 7,884 prescribed units in Q1 2026.
The number of unique prescribers rose from 2,377 in the fourth quarter of 2025 to 3,228 by the end of the first quarter, with both sets of data reported in Symphony Health Metys data. We are pleased with our sales force's ability to drive a significant increase in prescriptions in Q1, despite seasonal dynamics at the start of the year and severe weather conditions disrupting operations in January. Our belief remains strong that ZELSUVMI is revolutionizing the treatment of MC and is becoming the first-line treatment of choice for many HCPs and patients. We affirm this confidence with the increased utilization of ZELSUVMI in April 2026. Prescribed units in April were 3,776 versus 3,309 in March.
We continue to see weekly highs in our prescribed units with our latest data week ending May 1st, hitting an all-time high of 917 prescribed units. Our coverage for ZELSUVMI remains strong in 2026. As of today, we have a 59% coverage rate for commercial insurance plans and an incredible 99% coverage rate for Medicaid. This is a testament to the fact that ZELSUVMI, as the first FDA-approved at-home treatment for MC, is being adopted as a first-line treatment option and is being well-received by HCPs and coverage providers. As previously announced, we executed a contract with a large PBM to remove friction and help gain access to ZELSUVMI for many patients. This effort has continued to help many patients gain rapid access to ZELSUVMI. For Medicaid coverage, a large number of states do not require a prior authorization.
For other states that require a PA, Medicaid only requires a prior authorization written to label, meaning that a patient over one year of age presenting with MC qualifies for coverage. We also continue to have very good Gross-to-Nets or GTNs. Our current GTNs largely revolve around distribution costs, Medicaid discounts, payer contracts, and our co-pay voucher program. It is our goal to pay down with the co-pay card program so that prescription costs are $0 or close to $0 for the patient in most instances. For the first quarter of 2026, we had favorable GTNs of 29.1%, in line with our expectations, and going forward, we are expecting our GTNs to move to the mid-30% range. I would like to provide an update on our sales team.
As mentioned previously, we commenced the launch of ZELSUVMI in July 2025 with 50 territory managers, placing them in locations based on the ICD-10 data of most prevalent MC cases. We announced an expansion of an additional 14 territory managers in Q4 2025 in metropolitan areas not previously supported by the original sales footprint. Q1 data suggests that this is a highly effective expansion as prescriptions in many of those territories have jumped markedly to the point where in a very short time they have covered the costs of their sales efforts entirely. We continue to grow awareness and utilization for ZELSUVMI as the first and only at-home prescription treatment option for MC through various channels and venues. Our ZELSUVMI YouTube commercial continues to be very successful with more than 6.7 million total views.
This unique and informative short-form video has prompted parents and caregivers along with adult patients to ask their HCPs about ZELSUVMI. To further our digital outreach, we launched a new YouTube video in April featuring a real patient testimonial, including a young patient and a renowned pediatric dermatologist. This effort helps educate parents and caregivers on the benefits of treating MC with ZELSUVMI. The video and others like it to follow also help HCPs understand the significant benefits ZELSUVMI can provide for their patients very quickly.
We will also continue to attend key conferences throughout 2026, educating HCPs on featured benefits of ZELSUVMI for their patients. Our attendance and presentations at these meetings have garnered significant attention and generated vast HCP leads, resulting in significant prescriptions from many new prescribers. We continue to build off our great tactical platform along with strong execution of our sales team to grow Xeglyze. I'm very pleased with our strong performance to date alongside our highly passionate, dedicated, and hardworking commercial team. With that, I now turn the call over to John to discuss our financials. John?
Thank you, Sai. Good morning, everyone. I am pleased to be with you on today's call, and thank you for joining us. As Scott and Sai have already touched on, we continue to see increasing demand for our flagship product, ZELSUVMI, as demonstrated with our growing pull-through and dispensed units to date. Please note that my comments will focus on our first quarter 2026 results as compared to the fourth quarter of 2025, as the first quarter of 2025 is not comparable due to the timing of our merger in July of last year. For the first quarter of 2026, we reported $10.7 million of net product revenue, representing a 17% increase from the fourth quarter of 2025.
With today's filings, including our quarterly report on Form 10-Q also filed this morning, we have now completed and reported on three full fiscal quarters of commercialization efforts for ZELSUVMI. While these quarters straddle two fiscal years, we have reported in aggregate $26.9 million of net product revenue for the three fiscal quarters since commercial launch of ZELSUVMI in July of 2025. This amount is comprised of our net product revenue from the third and fourth quarters of fiscal 2025 of $7.1 million and $9.1 million respectively, plus $10.7 million of net product revenue for the first fiscal quarter of 2026. In both the first quarter of 2026 and fourth quarter of 2025, cost of goods sold was $1.7 million.
During the fourth quarter of 2025, write-offs of inventory totaled $121,000 related to previously capitalized process validation expenses. As discussed on prior calls, a component of our cost of goods sold includes fair value adjustments associated with the July 2025 merger. At the time of the merger, all finished goods and active pharmaceutical ingredient inventory on hand was fair value as prescribed under U.S. GAAP. We expect to run through the stepped-up fair value finished goods inventory by late summer of 2026 and approximately 12 - 15 months thereafter to consume the stepped-up fair value API inventory. Once we have sold all the inventory with a basis step-up, we expect to have a normalized per unit cost of goods sold of approximately a mid-single digit percentage of our current WAC price.
For the first quarter of 2026, we reported $21.1 million of SG&A expenses, representing a 14% increase from the fourth quarter of 2025 at $18.5 million. We provide a detailed breakdown of the components of SG&A within the MD&A section of our quarterly report on Form 10-Q filed this morning.
In summary, the $2.6 million quarter-over-quarter change in SG&A was primarily related to an anticipated increase in total cash base personnel cost of $1 million, which excludes stock-based compensation but includes the expanded sales force, an expected increase in marketing and commercial spend supporting current and future net revenue growth of ZELSUVMI of $1.5 million, an increase in regulatory and manufacturing related expenses of $1.2 million, an increase in royalties expense of $300,000, and non-cash depreciation expense of $200,000, and a reduction in corporate expenses of $1.6 million. Total cash basis SG&A, excluding royalties, was approximately $16.9 million for the first quarter of 2026 as compared to $14.7 million for the fourth quarter of 2025.
We expect that quarterly cash basis SG&A, excluding royalties, will fluctuate in 2026 as we continue to invest in the expected growth of ZELSUVMI and as we prepare Xepi and Xeglyze for commercialization. Interest expense for the first quarter of 2026 was $2.4 million as compared to $1.3 million for the fourth quarter of 2025. Interest expense is attributable to the company's existing convertible notes and its Horizon loan facility and the accounting treatment of certain royalty and purchase agreement obligations entered into by the company. Net loss for the first quarter of 2026 was $10.2 million as compared to $21.7 million for the fourth quarter of 2025.
Whereas adjusted EBITDA for the first quarter of 2026 was a - $8.0 million as compared to a - $7.6 million for the fourth quarter of 2025. Now turning to our balance sheet. As of March 31st, 2026, we have $32 million of cash and $11.7 million in accounts receivable. Our working capital at the end of the first quarter of 2026 was $44.8 million as compared to $27.4 million at the end of the fourth quarter of 2025. As Scott mentioned, during the first quarter, we entered into the Horizon loan facility, which after netting fees and expenses, added cash of $27.5 million to our balance sheet.
Based on current projections, including forecasted cash flows related to net product sales of Xeglyze and proceeds from the initial draw of the Horizon facility, we believe we have the capital and flexibility needed to advance and execute our business plans.
In summary, our performance since the launch of ZELSUVMI in July of 2025 has exceeded our expectations. Furthermore, since launch, we have strengthened our balance sheet and believe we are well-positioned to continue our commercial execution story, bringing a much-needed treatment to molluscum patients. With that, I will now turn it back over to Scott. Scott?
Thank you, John. In closing, I'd like to highlight a few key points. To begin, we are extremely pleased with the success of the ZELSUVMI launch and our financial results to date. As we remain relatively early in our launch, we have not yet provided discrete revenue and earnings guidance. However, we remain extremely confident about our revenue growth trajectory and believe that our current cash balance provides the runway to execute our business plan. I wanna thank you for joining us today to learn more about the Pelthos story, and will now turn the call over to the operator for any questions.
Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you'd like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we request you to limit to one question and one follow-up question per participant. One moment, please, while we poll for questions. We take the first question from the line of Olivia Brayer from Cantor Fitzgerald. Please go ahead.
Hi. Good morning, nice quarter, and thank you for the question. What are you guys seeing at this point in terms of repeat prescribers? I know it's early, but can you quantify how many repeat prescribers you have at this point? Are you starting to see a bigger proportion of physicians that are actually increasing their written scripts of ZELSUVMI? On Gross-to-Net, when do you guys expect to actually hit that mid-30% range? Is that something that could happen by the end of this year? Is there a stepwise function, or should we think about the step up over time over the course of the year, any differently? Thank you so much, guys.
Thanks for the questions, Olivia. This is Scott. First off, regarding repeat prescribers, we've been very encouraged with two important metrics. One is new prescribers. In any given week, really in the last month or two, we are seeing anywhere from 170 to 200 first-time prescribers. Really the highest levels we've seen since launch as far as adding new prescribers. Importantly, repeat prescribers has been trending right along with our script trends. The most recent data week, for example, we had over 500 repeat prescribers. Exactly 500 repeat prescribers, the highest level it's ever been. We're encouraged by not only new prescribers coming on, but those that are writing scripts over time and adopting the drug. I'll let Sai go into a little bit more depth around that.
Yeah. Thank you, Scott. Good morning, Olivia. Thanks for the question. In addition to what Scott had mentioned, we see a tremendous amount of trial utilization currently based on our really high NRx numbers. A large proportion, as Scott mentioned, week over week, still continuously start to again repeat prescribe because they see the value it's been providing for their patients qualitatively. As we've mentioned on previous calls, we're starting to hear more of the product utilization and the efficacy a bit faster than what's in the packaged insert, which is really what's contributing to a lot more utilization amongst those prescribers. It is a key focus area for us commercially as well. I believe our strategy and our approach tactically is what's resulting in some of those efforts.
The last thing I'll add to that is we track our prescribers, the number of units they prescribed, over time, obviously, and we have different bands that we look at. If you were to compare Q1 to Q4, really in every band, we've seen a nice jump up in each different range, including those that have written over 100 units since we've launched. On the GTN side, you know, we're really encouraged by the ability to keep our GTNs below 30% so far, you know, this quarter being at 29.1%. We do see that possibly going up in the future. We're evaluating whether we do a contract with another payer that has been, you know, more difficult than the others.
It's always been our strategy to get into market and decide where we need to contract, where we don't. I think that mid-30s% gives us some headroom to do that if we want to do that contract. We don't know the timing, and again, a lot has to be decided there and worked through. You know, obviously right now at 29.1, it's very favorable to us.
Okay. Very helpful.
Thanks, Olivia.
Thank you, guys.
Thank you. We take the next question from the line of David Amsellem from Piper Sandler. Please go ahead.
Thanks. Just regarding the Gross-to-Net, I know it's going up, but thinking longer term, particularly as you consider, other contracts, do you have a good read on what steady-state will be? Is the mid-to-high 30s% a good way of thinking about it? Secondly, how are you thinking about further sales force expansion down the road, particularly with Xepi and Xeglyze? Lastly, just latest thoughts on your willingness or appetite for adding another product to the bag. Maybe not in the near term, just given the upcoming launches, but longer term as you think about further growth of the business. Thank you.
Good. Thanks, David. Appreciate the questions. I'll handle the GTN and then adding to the bag, and I'll let Sai address the expansion or potential expansion. On the GTNs, we feel very confident that the mid-30s% is a good number going forward, based on kind of what we see in front of us. And again, the ability maybe to do one more contract. We don't know and don't believe we'll have to do much beyond that. We're seeing very favorable approval rates. We feel like patients have very good affordable access. In fact, we've seen even, you know, the time to process PAs has gone down dramatically over the last, you know, few months here. That's all a positive.
As far as adding the bag, obviously, we've been very optimistic in adding highly complementary products to ZELSUVMI. You know, we'll continue to evaluate opportunities that present themselves to us. You know, we're really trying to, you know, build a, you know, a premier company here. They'd have to make sense. They'd have to fit. We don't want to go off strategy and run off into a different specialty, we'll be very disciplined if we were to do that. For now, we need to get ZELSUVMI, launched, continuing down the path it's on with the same momentum. Need to get that right first and foremost, then layer in Xepi and Xeglyze. That's our focus now, trying to build the best company every morning when we wake up. If something presents, we would definitely look at it. I'll let Sai talk about sales force sizing.
Yeah. Thanks, Scott, and good morning, David. Just on the view of our expansion to date, our expansion that we announced, basically earlier in the year and really deployed earlier in the year has been quite successful for us to date. We're seeing increased scripts week over week from that cohort. In terms of Xepi and Xeglyze, our intent is for all of the field force, all 64 territory managers, to carry all three products. And the way in which we've been operating is really ultimately earning the right to expand. Looking at our progress to date, looking at the weekly data and how that will roll up monthly, quarterly, and then decide upon some key areas.
We will actually, in fact, be adding three new additional territories here by June, and that's going to be specific areas like Albany, Pittsburgh, and Shreveport, Louisiana. Again, that was very tactically analyzed and really an opportunity for us to ensure that we can maximize the footprint. As of this point, no imminent expansion as we would call it, but looking at it tactically and really focused in a highly targeted and measured way.
The last thing I'll add, David, is that Xepi and Xeglyze, one of the reasons we really like those acquisitions is that does not require us to expand our sales force around those products. They're in the right offices, calling on the right healthcare providers. It just allows us to leverage the team going forward. So it's really about bringing other revenue into their bag, each and every day. So great fit for us.
All right. Thank you.
Thanks, David.
Thank you. We take the next question from the line of Brandon Folkes from H.C. Wainwright. Please go ahead.
Hi. Thanks for taking my questions, and congratulations on the quarter. Sorry if I missed this, you know, can you just remind us or update us on the split of business between derms and pediatricians? You know, obviously, you've had great success so far with Xeglyze. Any color on how you think about the commercial infrastructure post the addition of the new reps and future investment from here, you know, especially with the two additional products potentially coming to market? Thank you.
Yeah. Brandon, I'll let Sai talk about the derm ped split and maybe then talk a little bit about infrastructure and spend around that the other launches going forward.
Yeah, sure. Good morning. Good morning, Brandon. Thanks for the question. The current distribution that we see definitely anchors more towards dermatology, as we've mentioned previously, being a cutaneous infectious disease product. Dermatology is usually where products like these and adjacent products typically get utilized the most and frequently. However, we have seen an increased utilization point amongst pediatricians, and that's a mix between standard pediatrics and the NPs and PAs that also support them. We see about 25%-27% utilization in the pediatrics category. Again, anchoring a bit more towards dermatology and the overall, you know, kind of utilization points as they see it.
In terms of the second part of the question around investment, around commercial infrastructure, aside from what we've already mentioned with the field force, we're really anchoring towards some really cost-effective but highly impactful non-personal promotional efforts. As I already mentioned in our prepared remarks, we have some really high success utilizing platforms like YouTube, but we do also invest in other third-party platforms for where HCPs go to actually get their information, and it comes across in a very objective manner about the clinical profile of the product. Ultimately, should they choose to utilize Xeglyze for appropriate patients, there's support mechanisms embedded within there for them to seamlessly prescribe.
We will continue to invest in those particular arenas because one, it's supportive of the HCP population, but also supportive of the patients, the caregivers, the parents that are seeking treatment. We will continue to monitor those to make sure, again, that they're providing the intended results.
Yeah. What's nice about the little bit of time here with the Xepi and Xeglyze launches, Brandon, is that we can also, you know, do more work with the different thought leaders. We're also, our medical affairs team has done a really nice job now of building up some interest in publications around these different products and their indications. They'll actually be different posters and abstracts and publications that, you know, will be out in the public domain as we go to market too. Those are some things we're looking to put in place. Again, all, as Sai mentioned, all very cost-effective and, you know, most of our resources are going to ZELSUVMI.
Great. Thank you very much, and congrats on a really good quarter.
Thanks, Brandon.
Thank you. We take the next question from the line of Jeff Jones from Oppenheimer & Co.. Please go ahead.
Good morning, guys, and congrats on the really nice quarter. I guess two from us. As we look ahead 2026 and 2027, where are you focusing in terms of growth? Is it, is it more new accounts, or is it deriving greater use within existing accounts? Which do you see contributing to the greatest extent in your forward revenue growth? Then drilling down on the pediatricians versus dermatologists, do you see this mix changing with more dermatologists or rather more pediatricians out there in the market and seeing these patients sooner? Can you comment on maybe the, where you're seeing the greatest traction within those accounts and maybe the pushback you see, respectively?
Jeff, I'll let, I'll let Sai jump in on these questions and handle the new and repeat what, you know, where we're focused as far as, new prescribe depth or breadth, I guess, is the way to look at it, right?
Sure. Thanks, Scott. Good morning, Jeff. Thanks for the questions. Again, depth and breadth are really important metrics and really important areas that we focus on. We still very much are in launch mode. Obviously, we just completed only our third quarter in the launch, and we're deep into our fourth quarter, really making sure that we're growing, you know, month-over-month. Depth and breadth are equally important today. As we mentioned earlier on this call, we are seeing a good amount of repeat prescribing, that's where within that cohort, if you can get them to continuously prescribe, that really, again, helps the growth curve. We really do need to be adding on a tremendous amount of new prescribers, which we are doing at a high clip.
I would say both, you know, areas are equally important, and we're really focused on them. I would say, you know, week-over-week, we're seeing that the numbers are increasing across the board. From a derm, peds split, and in terms of utilization, as I mentioned, definitely a higher extent of dermatologist utilization as expected. But the growth in peds, I think is above our expectations at this point. And the fact that they are looking for an at-home, first-line treatment option, which we are positioned very well within those particular accounts. Really, I would say, we expect, you know, both categories, if you will, of derms and peds at large and the NPs and PAs that support them to grow with volume.
As we grow, quarter -over -quarter here, we should see both cohorts, you know, start to grow. We should intend to see the pediatric side of things grow markedly with that as well. As per your last question around any pushback, to date, we have not received any clinical pushback. The profile, as we are out there promoting and educating through our venues commercially and within our medical affairs team, the clinical profile has been received very, very well, and the real-world utilization has also been received incredibly well.
The only types of pushbacks that we would typically hear and see are going to be access-related, by which we have a tremendous amount of resources that help with the PA medical necessity process, a robust, co-pay card program, and really to intend that we're able to deal with any kind of friction or challenges. Really, that's why we brought on that additional payer earlier on or late last year into this year. Those are the measures that we really have in place with our Pelthos commercial team to date.
Great. Really appreciate it, guys. Thanks.
Thanks, Jeff.
Thank you. We take the next question from the line of Thomas Flaten from Lake Street Capital Markets. Please go ahead.
Hey, good morning, guys. Thanks for taking the questions. Sai, just perhaps an obvious question, but I want to ask it. With the, I think anchoring is the word you used in the derms versus peds, does that align with how your targeting is designed as well, or is that just more happenstance where derms have been the quicker adopters and peds are coming on board later?
Yeah. Thanks for the question, Thomas. I would say there's an equal amount of focus on both categories from a targeting standpoint and what we do both personally and non-personally. I think because the dermatology community is historically the specialty that's been, let's say, referred to for the disease state, they are the obvious initial treaters. But the ramp that we've seen from launch to date, again, ahead of our expectations in pediatric utilization, primarily because of our promotional and educational efforts to the category, have then garnered the increase that we see here at this point. That's, again, an increase that's occurring month-over-month within the pediatric category.
I think, again, our efforts are aligned equally, and I think we'll provide the end results as we go forward, and quite frankly, will help the future product portfolio in that same manner.
Yeah, the last thing I'll add, Thomas, Can I just add on it, Thomas? This is Scott, really quick. I think you also have to look at historically what those two different specialties have done when they've seen molluscum, and the derms, based on claims data, over 50% of the time, 50%-60% of the time, they actually were treating prior to us launching. What I mean by that, they were doing a destructive modality typically. In the ped space, it was probably only 10%-15% of the time did they actually do a destructive modality and treat, and they typically would take a more wait and see approach.
I think that's why you actually see about half the patients that get to a derm are referred by a ped because they don't treat, the disease progresses, and it ends up in the derm practice. We believe that, you know, with a at-home choice that's very importantly safe and efficacious, that, you know, we can change that paradigm, and they'll start adopting the drug 'cause they actually have something. The parents are taking kids in wanting to be treated. When they say wait and see, that doesn't go over very well with the parents, and they're looking for options. I think, you know, being the first FDA-approved at-home therapy is, you know, kinda game-changing for the pediatric practice. I think it's just gonna take some time there.
Well, yeah, it's interesting, and you kind of alluded to it, Scott. Where I was going with this was I was curious. You know, what we've heard from derms is they'd rather not see the MC patients at all. They'd rather, you know, be doing something that's far more profitable. I'm curious if there would be a long-term opportunity for you guys to help the derms leverage their referral networks to keep the MC patients out of their practice and allow the peds to treat them primarily.
Yeah. It's a great point, Thomas. This is Sai. I was actually gonna mention that but didn't wanna elongate the commentary. We are already beginning to do that more so, where we have our dermatologists really being, as the word we've been using this morning, the anchor to really making sure they convey the messaging to those pediatricians out there who are indeed first line, as you mentioned. That is something we are doing today, and I believe that is actually helping the increased cohort of utilization. I think over time, as mentioned, with volume, we'll start to see the specialty increase more so within general peds and, again, the supportive staff that they do have, treating the disease, again, because they see it at first line. We being a first and only at-home treatment option truly will be a great benefit to them along with the strong clinical profile.
Excellent. Thanks, gentlemen.
Thank you.
Thanks, Thomas.
Thank you. We take the next question from the line of Jonathan Aschoff from Roth MKM. Please go ahead.
Thanks, guys. Congrats on the quarter. I was just curious, what is the average number of prescriptions it takes, you know, to either cure a patient or at least for them to stop ordering it? I guess you really can't tell that difference. Given all the trials that this product's been in the hands of a Novan, are you aware of any off-label use?
Jonathan. I'll take the first question. What we're seeing in the data as far as units, every patient's different. We really can't say there's an average number to a complete clearance, which is kinda the, you know, the gold standard here, you know, the ultimate goal. What we do know is if you can get at least a 50% clearance, that is clinically meaningful. That's what we hear over and over again from our KOLs. What we do see in our data is probably about 1.2- 1.3 units per patient. And, you know, if they were using it, you know, per the directions, using a dosing card and use that exact amount every time, that would last 30 days.
We do know, obviously, in the real world, people miss doses. We saw it in our studies even. In our studies, it didn't impact efficacy. You know, there may be that. They may not be using as much as the dosing card, you know, indicates to use. We do think it's getting extended for those two reasons also. You know, somebody that only uses one tube may be stretching it to one and a half, two months worth of therapy for all we know. We can say that it is about 1.3 units per patient. I'll let Sai jump in and provide additional details here.
Yeah. Just to add on to the commentary, I think qualitatively, we keep hearing that the product is working a lot faster than what's suggested within our package insert, which is a great situation to be a part of because the efficacy and coupled with the safety mechanisms when, you know, utilized correctly, we're hearing a lot of really great stories and patient testimonials through the patients themselves and the HCPs that are supporting them about the faster results of the product. Qualitatively, that is definitely contributing to where, if we think about it from a refill standpoint, we're seeing, you know, increased NRxs, less refills predominantly because of the clinical profile that's working a lot faster for those patients.
Yeah. Regarding off-label, obviously, we don't track that first off, you know, to be clear. The reps, obviously, are trained to be highly compliant. We do have an avenue or an outlet for questions that are off-label to go through medical affairs and handled appropriately. I'd say that the areas we see the most questions around are the use in common warts, as well as genital warts. Those are probably the two most...
You know, I mean, the reps have ears, so no actual prescriptions there that you're actually aware of?
Yeah. This is Sai. I can address that. There is no situation compliantly and legally where we have our reps entertaining any of those conversations or responding to them. Regardless of what they might hear qualitatively out there, all those questions and commentary, to Scott's point, are directed through a very specific and compliant channel, which is our medical inquiry request form, which then is handled directly from our medical affairs team. There is nothing that is shared directly from them to anyone as they are trained compliantly.
Okay. Thank you for that. Lastly, you know, given this ease of administration compared to some other approaches that are a lot more hands-on, do you foresee that maybe disrupting the seasonality of treatment, making people, you know, more willing to treat in those colder months where it's just not that much of a decision to make to get treatment just 'cause it, you know, it's a lot easier, simpler for the patient?
First off, there are a lot of patients not seeking treatment, and I think just having an at home option that doesn't require a procedure will definitely drive patients in over time. There's still work to be done there, and we've seen, you know, our YouTube commercial, we've seen 6.5 million views there. People are definitely going and trying to learn. Really, Jonathan, I think the seasonality also is tied a little bit to just offices being open or not. Being an acute medication for the most part, where we're really driven by new prescriptions, if an office is shut down or closed, or just reduced staffing for, you know, two, three days, you know, in December, November, that can have an impact on those months.
You can lose 10%, 15% of the business, or the opportunity to treat patients. I think that's probably a bigger part of it than, you know, and then obviously weather. We saw a big weather impact in the Northeast, and even parts of the Midwest, this year. It's that, and then if you think about it, you're covered up more too. You know, it probably isn't as visible. People aren't asking about it, so kids aren't, you know, feeling like people are saying, "Hey, what's that on your? You know, what's on your skin? What is that?" They start feeling anxious. Parent takes them in because, you know, they're upset. You're covered up and it's less likely to be visible to others.
Got you. Thank you very much, guys.
Yep. Thank you, Jonathan.
Thank you. We take the next question from the line of James Malloy from Alliance Global Partners. Please go ahead.
Hi, guys. Thanks for taking our questions. Matt on for Jim today. Congrats on the quarter. Just one, two for us. Do you have any color on the percentage of scripts written by telehealth providers and/or fulfilled by Amazon Pharmacy or similar services kind of directly to the patients? Any color would be great there. Thank you.
Good morning, Matt. This is Sai. Thanks for the question. From a distribution standpoint on mail order, we see that probably closer to the 10% range of all of our prescriptions that are distributed via traditional retail channels or pharmacy channels. Again, Amazon is mixed in within that traditional mail order channel, just around 10%. From the breakdown of telehealth versus in office, it is actually not a metric that we can break down objectively because even offices that see patients live also have a component of their office that's telehealth though, so it's not really marked as that in our data. They might mark that as their data within their respective practice. We don't really have an objective measure that I can share with you.
However, I do hear qualitatively it's used in the telehealth channels, just as equally as it is in office from a prescription mechanism. Good question. I think from a qualitative view, we definitely see that it is being utilized via that channel.
Great. Thank you, guys. Again, congrats on the Q.
Thanks, Matt.
Thanks, Matt.
Thank you. Ladies and gentlemen, as there are no further questions, I will now turn the call back to Scott Plesha, Pelthos CEO, for closing remarks.
Thank you, operator. I want to thank everyone for joining today's call. I'd also like to thank the employees of Pelthos for their continued focus, execution, hard work, and dedication in supporting patients, caregivers, and healthcare providers. Thank you again for joining our call, and we look forward to updating you on our progress in the future. Have a great day.
Thank you. Ladies and gentlemen, the conference of Pelthos Therapeutics has now concluded. Thank you for your participation. You may now disconnect your line.