Good evening, everyone, apologies for just the slight delay in logging in here. We have close to 400 people pre-registered for the event, but we are at the bottom of the hour here, so we're going to get started. So everyone joining us from North America, good evening. Everyone from Australia, a pleasant good morning to all of you. I'm Vince Ippolito, Executive Chairman of the Board of Botanix Pharmaceuticals, and we are pleased to present the Botanix Quarterly Activity Report and 4C Quarterly Cash Flow Report for the period ending 31 December 2025. Today, we're speaking to you live from the 2026 Botanix National Sales Meeting. It's an annual gathering of our sales professionals and company employees.
Here, we do advanced training with the sales representatives, lay out the key objectives and tactics for the upcoming quarters, but most importantly, we recognize outstanding sales performance from our top sales representatives. As you would imagine, there is a lot of high energy and enthusiasm from our employee base on our first successful launch year here at Botanix. It was just one year ago, we were at the company's first national sales meeting, preparing our sales professionals to launch Sofdra the week after they left. The company's come a long way in the past 11 months, that's in 2025, since that highly successful commercial launch of Sofdra, and we're very pleased with the progress that we've made and believe that we're well-positioned for future growth. At the end of this presentation, we're gonna have some time for a few questions.
You can put them into the chat. We'll try to get to as many of them as possible, but without any more delay, I'd like to turn the presentation over to our Chief Executive Officer, Dr. Howie McKibbon, and our U.S. Chief Financial Officer, Chris Lesovitz. They'll take you through today's presentation. So Howie, all yours.
Yeah, thank you, Vince, and thank you to all of our current investors for joining and our prospective investors. We're gonna break the presentation down into two parts. We'll give a brief background of the company, where we've come since launch, and then get into our quarter results. So Botanix is a fast-growing dermatology company, and we successfully launched Sofdra last February for the treatment of hyperhidrosis, commonly referred to as excessive sweating. So Sofdra, it's the first and only NCE, or new chemical entity, for primary axillary hyperhidrosis. This affects over 10 million patients in the U.S. alone. Now, just to put the value of what an NCE is worth in, into perspective, there were only about 44 new chemical entities approved in the U.S. across all therapeutic categories in 2025, and one of them was Sofdra.
Now, moving on to our fulfillment platform, it's proven to increase patient adherence, which, as you know, is the extent to which a patient stays on drug treatment. In fact, the refill rate exceeds the industry standard by 250%. So ultimately, when a patient gets on product, they're very sticky throughout their patient life cycle. We'll further discuss that innovative platform, what makes it a key value driver for Botanix in the coming slides. As many of you know, we completed the sales force expansion from 27 to 50 sales specialists in late October. So both the new hires and existing sales specialists have been highly productive. They're performing like we planned they would, and in many cases, better than we planned.
We expect the new sales specialists will continue to build increasing momentum in the coming quarters as they increase market penetration to both new physicians and to new areas of the country. We look forward to helping them contribute in a meaningful way to increase Sofdra prescriptions and help as many patients as possible get on therapy. Next slide, please. So this is our team. It's a highly experienced board and management team, and together, this particular group has successfully commercialized more than 30 derm products between them. They also represent multiple dermatology companies. They have an unrivaled track record, not only commercializing these products, but also exiting derm companies to larger partners ultimately. Next slide, please. There's a pretty, pretty large target market for Sofdra, 10 million patients alone in a very underserved patient population.
So to put the market opportunity in perspective, consider that primary hyperhidrosis affects twice as many people, more than twice as many people, as psoriasis, which in the United States is generally recognized as a pretty large disease state population. In fact, hyperhidrosis is the third largest derm or dermatologic condition, third only to acne and atopic dermatitis, with the 10 million patients that we have in the U.S. And keep in mind, 3.7 million of those 10 million are already seeking treatment in the physician offices that we're calling on. So a good opportunity with a very impressive product so far. Next slide, please. So as I said earlier, we launched Sofdra last year, prescription medicine for excessive underarm sweating, but it goes down to children 9 years of age and older.
Presents a novel, safe, and effective solution for the greater than 10 million patients in our TAM, who've lacked treatment options for this medical condition in the past. So we believe the novel mechanism of action of Sofdra allows it to reduce sweat at its source by selectively binding to the M3 receptor, which is implicated in sweat signaling. It's rapidly metabolized as it enters the bloodstream, which helps minimize systemic adverse events. Physicians have told us that Sofdra's proprietary metered- dose pump, that you can see on the right-hand side here, is one of the main reasons they prescribe Sofdra, so patients aren't getting the product in areas where they're not intending it to be. Next slide, please. Now we'll move over to our fulfillment platform. This is a huge asset for the company.
It's innovative within the United States, in that it provides seamless fulfillment through a single pharmacy network that supports both derm practices and patients, and ultimately mails not only the initial prescription to patients very quickly, but also the subsequent refills. That's a key value driver, among others. Another value driver is its ability to improve insurance clearance rates. Ultimately, we get a higher number of fully reimbursed prescriptions, which improves the gross-to-net yield. The design allows for personal follow-up with patients by the pharmacy, which effectively drives that adherence, and gives both the patient and the physician a concierge experience, which ultimately, from what we've heard in our market research, causes physicians to prescribe even more. A side benefit here is that we have very high visibility into pharmacy operations, which enables rapid insight and our ability to make decisions quickly.
It immediately provides margin benefits for Sofdra, which also contribute to the improved gross-to-net yield versus our competitors. I think most importantly, it's scalable to do the same for future Botanix products. Next slide. All right. We're excited to talk about what's happened in the past year. Before I move on to the quarter results, I want to take a step back and holistically look at where we've come. We've moved from a non-revenue generating development company to a revenue-generating company approaching almost $100 million in cumulative gross sales. In the 11 months from February to December, since the launch of Sofdra, cumulative gross sales rose dramatically from a negligible amount to $93.5 million. Cumulative net revenue grew significantly from a minimal sum to $21.2 million, and total prescriptions increased very substantially to 62,500.
So I want to take a second to highlight this achievement because it's important to acknowledge the team behind this, which helped us go from essentially no sales to where we are today, 11 months later. So as you know, we launched with only 27 sales representatives, and due to the strong physician responsiveness to the benefits of Sofdra and the positive patient experience, we quickly expanded, quickly expanded the sales team to 50 reps, in the December quarter to meet the expectations of physicians in, in service and to expand the number of physicians that we can get the message to. Now, the original sales representatives in the first quarter of launch outperformed 3 recent dermatology product launches in the comparable quarter. So it's a testament to the team the company's pulled together, and we thank them for their efforts over the past year.
So lastly, I think it's worth mentioning, we have very long patent coverage here by comparison to, you know, many products that are out there, going out to 2040. It's a valuable asset for the company, having 15 years of clear runway to continue to commercialize the product, and as always, we'll continue to seek ways to strengthen or leverage that patent coverage. Okay, so why don't we move on to the financial results on the next slide? So total prescriptions shipped grew 24% versus Q1, driven by our fulfillment platform and a productive sales team. The increase in prescriptions and strong refill rates indicates rapid acceptance of the benefits of Sofdra by patients and physicians alike. Net revenue increased by 28%, quarter-over-quarter to $9.1 million versus $7.1 million in Q1, fiscal year 2026.
Gross-to-net yield continued to improve up to 24% versus the 23% in Q1, and it showed continuous improvement quarter-over-quarter. So we're pleased with the improvements in gross-to-net yield, given that the ... I'm sorry, 23 new sales specialists were educating physicians for the first time on how to use the platform. And it worked even faster than it did with the initial 27 sales representatives. So we're excited to see the continued improvement in gross- to- net over time, ultimately, as we move toward that 30%-40% target. Next slide. So you can see here that Sofdra's demonstrated solid growth in total prescriptions shipped each quarter since launch in double digits, and we'll look forward to continuing that momentum and seeing the full contribution of the new sales representatives next quarter. Next slide, please.
So net revenue increased from $7.1 million in Q1 to $9.1 million in Q2, representing a double-digit increase of 28%. Net revenue has grown quarter-over-quarter since launch, and we expect this to continue for the foreseeable future for many of the reasons we've already discussed today. Over to the right, you can see the gross- to- net yield has also improved in each consecutive quarter, which is pleasing to see. We note that over time, the company aims to achieve that target I spoke to earlier of 30%-40%, which is typical only of the successful US dermatology pharmaceutical companies in the United States. Achieving closer to this range would have a significant positive impact on the company's cash flow, so we're going to continue to have a laser focus on improving this in the future.
On the next slide, we'll turn to some market research that we're very pleased to get the results on. It's typical at this time of product life cycle to conduct market research and find out how the physicians see the product, how they are prescribing it now, and how they intend to prescribe it in the future. Results show that Sofdra strongly resonates with our healthcare providers, and 90% of those surveyed expect to increase Sofdra prescribing in the next six months. This gives us great confidence in our product and its future growth. These in-depth market research interviews were conducted in late October and early November with U.S. dermatology healthcare providers, with a mix of dermatologists, physician assistants, and nurse practitioners.
Now, regardless of what type of prescriber they were, all the cohorts indicated that their use was driven by the streamlined process of the platform, the strong efficacy, the applicator, and the safety profile. They also indicated that many patients remain undiagnosed and untreated in their practices, which tells us there's still quite a bit of runway and opportunity for the activity that's ongoing in the physician office. So we're very excited to see what is going to come in the next couple of quarters. Next slide. So during the market research, they also gave us some direct quotes, and they told us why they chose to prescribe Sofdra to their patients, and we wanna share a few of those with you. You can read them on your own. I'll just pull a few out.
You can see the depth of one healthcare professional's preference for Sofdra, who proactively brings up Sofdra, even if patients aren't doing well on the current therapy. Another said that SendRx enables switching patients from a competitor to Sofdra, saying, "It makes it easy, and that's why it's my option now." In the area of patient adherence, another stated they have not heard of anyone discontinuing it yet. These statements show the enthusiasm for Sofdra and importance of the Botanix fulfillment platform developed by the company. We also appreciate hearing this kind of feedback from physicians when they're talking about our product. I encourage you to read through some of those, and we'll bring forward others as we get them in the future.
Now I'd like to introduce our US Chief Financial Officer, Chris Lesovitz, who will take us through the financial results.
Thank you, Howie. So I'm pleased to share our Q2 results and outlook. We've achieved another quarter of strong revenue growth while maintaining disciplined cost management. First of all, let's start off with the fundamentals. Our operating cash flow increased from 7... up to $17.2 million, up from $13.1 million in the prior quarter. The higher operating cash outflow was due to the addition of 23 sales professionals. With the addition of the 23 sales professionals, it included a one-month prepayment in October. There was one-time start-up costs associated with the sales professionals and production of our initial marketing materials needed. In addition, we had annual cash outflows, which included bonuses for corporate staff and the required PDUFA fee that we paid in the Q2.
Inventory closed in at approximately $27.5 million, which will be sufficient to support the higher prescription volume generated by the expanded sales force in the 3rd quarter, and to meet the continued strong demand for Sofdra. And importantly, available funding stands at $46.4 million, including $31.5 million in cash and $14.9 million in undrawn debt. Next slide, please. On the cost side, we maintained strong operational discipline throughout the expansion, even as we doubled the size of our sales force. This allowed us to scale effectively without overspending or putting pressure on the cash space. As you can see, product manufacturing cost increased 25% to $2.7 million in Q2, compared with $2.2 million in Q1. These costs reflect the conversion of raw materials into finished goods and exclude the purchases of API.
Once API procurement commences for future production runs, we expect a temporary uplift in cost before returning to normalized levels. Our operating expenses increased 43%, rising from AUD 10.2 million to AUD 14.7 million in a quarter. As I've mentioned, this was largely due to the expansion of our sales team to 50 sales professionals, and again, which included the one-time prepayment in October, as well as the initial start-up costs associated with these reps, and the one-time PDUFA fee, which also occurred during this quarter. In our staff expenses, you can see these increased by 32%. This was driven by the annual corporate staff bonuses, and our G&A expenses declined 22%, from AUD 2.4 million to AUD 1.9 million.
This is reflective of the tighter controls we had during this period for G&A expenses. Looking ahead, we remain focused on disciplined growth and execution. As noted, we expanded our sales reps from 27 to 50 reps during the second quarter. This investment is expected to support our accelerated revenue growth and to represent meaningful progress towards achieving break-even. Manufacturing costs are to remain stable when we continue to convert raw materials into finished goods in the periods without API purchases. Over the longer term, our priority remains optimizing production efficiency while managing API procurement cycles effectively. We continue to expect strong revenue growth, supported by the expanded sales footprint and underlying demand for Sofdra. With that said, I'd like to turn it back to Howie.
All right. Well, let's close with the three pillars that are gonna drive future success here at Botanix. We have a strong opportunity with Sofdra. We've talked about that today in great detail. Just to summarize, 10 million patients, very large market, and an underserved market in the past. And it's a perfect time to have a product with overwhelmingly high patient physician satisfaction. So we're pleased that Sofdra is performing even better than we've expected regarding its clinical and safety profile. Importantly, derms or dermatologists are highly promotionally sensitive to the product, and we've continued to see double-digit prescription growth, and we look forward to seeing more of, more of the same. We're confident in the future of the product, which is patent protection until 2040, so a very long runway in that pillar.
Secondly, we discussed our differentiated fulfillment platform, what it's doing for patients, physicians, and refills. And just a reminder, it immediately improves gross margin for almost any product, and it's scalable to be able to maintain the same high level of performance with exponentially higher throughput. So when the opportunity is right in the future to have other products to put on the platform, it immediately makes them more valuable. We've built a solid foundation for future growth and profitability. Consider this, clinical development was de-risked with the approval of Sofdra. The execution was de-risked with the hiring of the sales specialists, their performance, and the expansion to the new sales force. Operations were de-risked with the validation of the platform, having it work as expected or even better than expected.
We're moving toward an additional supplier to create manufacturing efficiencies, which will decrease cost of goods by 25%-40%. Each of these things serves as a foundation for future growth. We have 50 high-performing sales specialists to continue growth for Sofdra, and this is in an environment where 90% of the surveyed physicians expect to increase their prescribing within the fiscal year. These reps also have the capacity and the talent for additional products, and our fulfillment platform is ready to meet the need at the appropriate time. Both the immediate long-term future of Botanix is bright. Our focus is clear, and we're looking forward to coming back to you next quarter with another time period of growth, both for prescriptions, for net sales, and gross- to- net optimization. That concludes our presentation.
We're happy to take as many questions as possible in the time remaining, and with that, I'll transition back to Vince. Thank you.
Thank you, Howie, and thank you, Chris. We do have some time for some questions, and we did get a number of questions. A couple of these, where there were multiple questions, I've consolidated them together into a similar topic. Others were just gonna ask the direct question here. So, let's start off with a question about the gross-to-net. So the question is, in quarter two, the gross-to-net was 24% compared to 23% in the last quarter. So although an improvement, why just a slight increase here? Howie, can you take that?
Yeah. I'll take that one, Vince. We were pleased to hit 24% gross- to- net. As our new sales professionals activate physicians, those prescribers experience a learning curve as they're learning the process for SendRx, and it can temporarily reduce gross- to- net yield. I mean, if you think back to the launch, it was not only during a high deductible period, but they were learning the system and how to clear insurance. So for these new sales professionals, it's like another launch. So it was good to see that we got improvement even during that time period. Let me explain why we created the fulfillment platform itself and how it was designed to improve gross- to- net.
It bypasses the wholesaler, so our fulfillment platform bypasses the wholesaler, consigns the product directly to the pharmacy, so we ultimately get a cost savings there. It was also designed to deliver strong insurance clearance rates, increase the number of fully reimbursed prescriptions, and achieve the high refill adherence rates that we're getting as well. So all those things go into our gross-to-net yield, and we're looking forward to that continuing to improve over time, especially as these new 23 sales professionals get through that education phase.
Thanks, Howie. Chris, I'm gonna let you take this next one. There were a couple of questions about cash and debt and funding to get to profitability. So, I'm gonna read one of the questions straight then. Would you say you say you have AUD 46.4 million in cash and available debt. Is that enough funding to get to profitability?
Thanks, Vince. First, we'd have to look back at the 4C I just went through, right? As we mentioned, we just completed the sales force expansion in the quarter. So we virtually doubled our sales force, which was the main cash driver in the quarter. As well as there's some one-offs in there, too, when you look at our cash 4C. We had the prepayment, like I said, in October for the sales force. We had the initial start-up cost associated with that, the expansion of that sales force... and then we had our one-time yearly outflows of the PDUFA and the bonus for the corporate staff.
With that said, though, the cash outflows will be steady going forward, and the sales momentum is expected to increase to offset some of those costs. In addition, when you look at the 4C, we increased our cash receipts from product sales this quarter by 44%. So at the end of the quarter, we ended up with $31.31 million of cash, plus the undrawn debt and inventory at hand, which we do believe this meets our immediate needs. Our sales are growing quickly. We will likely have to buy additional inventory soon to meet our anticipated future needs that's associated with this. To do this, we will consider our various funding options when that time comes necessary.
All right, great. Thank you, Chris.
Mm-hmm.
Howie, I'm going to give you this next one here. It's on alternate API supplier. Why is the company highly focused on engaging on an alternate API supplier? Can you explain the rationale?
Yeah. Thanks, Vince. You know, we've mentioned before, I think, in the last quarterly, that we were exploring additional options for multiple reasons. Now, when we started to bring in potential partners, it became very clear to us quickly that we could save 25%-40% on our COGS or cost of goods sold. So, not only does this increase our gross profit, it also de-risks the supply chain, among other things. So in order to do that, we're going to need to secure the appropriate supply to bridge us to that additional supplier, and we're speaking with Kaken as to what that schedule could look like. They're vested to work with us because as we brought this information to them, they would benefit from an additional supplier with reduced COGS as well. So there's clear advantages to this initiative.
We're going to be focused on it very tightly in the coming quarters. You know, just to reiterate, when you see a potential 25%-40% savings on your COGS, that's very meaningful to your gross profit and ultimately, your profit point.
Thanks, Howie. One more for you here. There's a great deal of interest on the new sales representatives that started in the last quarter here. Several questions on that. You said you were pleased with the performance of the new sales professionals. How strong was their early performance here?
Yeah, the performance has been impressive. You know, comparatively, they're on track with the original on a prescription per rep basis, what the original 27 had done. Now, keep in mind, those were the 27 that did better than the comparable successful dermatology launches over the past, you know, five years. They started during a time here in late October and grew their territories when the U.S. holiday season was in full swing, right? So for those in Australia, we have Thanksgiving at the end of November, obviously Christmas and New Year's following. And this year, those holidays fell midweek, so there was some downtime for physicians and some of the sales reps, but mostly the prescribing physicians during that time period.
So we're very happy to see what they've done compared to what was done back in February, and we're optimistic as we move forward. Actually excited as we move forward because, you know, you see some... We're starting to see some seasonality in this market, and you come out of that in February and March, and those sales representatives will be in full swing. We're very excited to see what that uptick looks like, but also, impressed with what they've done to hold their ground during that time period, comparatively to what those original 2027 had done.
Great, thank you. Maybe changing gears here a little bit. Chris, I'm going to let you take this one. There were some questions about Kaken, mainly centered around the Korean launch of ECCLOCK. So, first off, can maybe you give just a little bit of background on that out licensing agreement, and then any updates that you can share on it?
Sure. A little history on Botanix's partner, Kaken. So they successfully launched ECCLOCK in Japan in November 2020. They secured a sub-license and a distribution agreement with Dongwha in June 2023 to bring ECCLOCK to South Korean market. Dongwha received regulatory approval for ECCLOCK for South Korea's Ministry of Food and Drug Safety on August 29, 2025. And just as of last week, January 19, ECCLOCK was launched in South Korea by Dongwha Pharma.
Okay. Thanks, Chris. I'm going to let you-
Mm-hmm
... stay in the hot seat here, if you don't mind.
Thank you.
Two or three questions here about tariffs, and mainly wanting to know how they're affecting our costs. I know we've, we've brought this up a couple of times before, but some people have noticed there were some recent tweets, not specific on pharmaceuticals, but just how have the Trump tariffs affected our costs here at Botanix?
Got it. Okay, what I can say, as of to date, the tariffs have had no impact on our business. But in abundance of caution, as mentioned previously, we continue to develop on an API source and explore other defensive measures, including other manufacturing sites. With that said, we do continue to monitor the situation very, very, very closely.
Okay. Thanks, Chris. We only have time for a couple of more questions here. Howie, question here about the market research. You said 90% of the physicians expected to increase their Sofdra prescribing. How do you come to this conclusion through the market research?
That's right. 90% of the interviewed healthcare professionals spoken to had to increase prescribing volume in the next six months. So I'll just take a step back. This is typical market research, as I said earlier, that you conduct at this stage of the launch. You're trying to get a better understanding of how the healthcare providers use the product now, who they're using it for, and how they expect it to use in the future. So the research focused on areas or questions like why they choose to prescribe Sofdra, its effect on competitive prescribing, the importance of its features and benefits. For example, the metered- dose pump, the ease of working with SendRx Pharmacy, et cetera. So we conducted in-depth market research interviews in Q3, mostly late October, early November, with those in the U.S.
Those that participated were a mix of high, medium, and low prescribers of Sofdra, both physician assistants, nurse practitioners, and physicians, all individuals who can prescribe in the United States. So regardless of what cohort they were from, Sofdra use was driven by its streamlined access, strong efficacy, and unique applicator, along with the safety profile. But really, those percentages in that order. So we're encouraged to hear that from our prescribers, but mostly encouraged by the fact that their intent to treat, right? Which is the term that's used to describe this, was that 90% of them will increase, whether they're low, medium, or high riders now, they're all gonna use more. So we're slowly moving, actually pretty quickly, moving those habits of physicians from either not treating, treating with something else, to thinking Sofdra first.
We're looking forward to continuing that momentum with the new providers or new prescribers that the expansion sales force will be focused on as well.
Thanks, Howie. We're gonna go with just two more questions here. Chris, your your question answer about Kaken spurred a whole bunch of questions about out-licensing. So I, I'll take the the first question here. What is the out-licensing strategy? And the second question that came up unique to that, when could we see Sofdra in Australia? So out-licensing of our asset is a very important strategy for the company. First and foremost, the successful launch and commercialization here in the U.S. is, is paramount to us. As we look across the globe, there are certain parameters that we wanna make sure that we meet before we out-license the drug. One, is there a favorable regulatory environment for us to get the drug approved and commercialize it in that market?
Two, can we be reimbursed or paid for the drug? Obviously, the United States is one of the most favorable markets in the world for that. That's why we started here. But also importantly, the platform has become a very important part of our success here, the United States, and can we replicate that platform in some degree in other countries around the world? So where Australia is a target for us, we can't specifically speak when, but out-licensing is a very important strategy. Howie, last question, and it's actually from this last slide that you just put up. Somebody asked a question about the refill rate at 2.5 times, and what they really wanted to ask is, is this unique to just dermatology?
Is this unique to other drugs that you see in the US? And you having a pharmacy degree, you're the most qualified person in the company, really, to talk about refill rates and prescriptions here. So I'll leave this last question from you and let you go ahead and close out the session after that.
Yeah. Thank you, Vince, and thank you for the question. You know, when we talk industry standard, we're speaking about dermatology, but overall, you know, within all therapeutic areas, refill rates and compliance or adherence is very low. We hear this even with organ transplant drugs, where somebody might wait a year on a list to be able to get a donor organ, and their refill rates on the prescription are extremely low. We only see very high refill rates and maybe pain in a couple of other therapeutic areas, but it's a challenge across all of them. In dermatology, specifically, it's been consistently low throughout the history that we've been involved.
So we've been focused on this for quite a long time, on how to get the adherence and compliance increased for a couple of reasons. You know, number one, it's good for the patient, right? The right drug, the right patient, with the right dose, with the right frequency. Ultimately, it's good for the company as well. It makes our patient acquisition costs very, very worth it, you know, as patients are getting more and more refills. So it's a constant focus for us, and in this instance, the platform is delivering. And that said, we'll always be looking to improve that over time. Until they're at 100%, we'll keep focused on that.
But that said, yeah, challenge across all therapeutic areas and baffling at times as to why patients don't necessarily take their medicine or get it refilled, but the data speak for itself. We'd like to thank everyone for taking the time, both our current investor base and those that are interested in Botanix. We're happy to talk with anyone over the coming week and the week after. We'll be quite busy this week with the national sales meeting, but we'll make ourselves available. And we look forward very much to speaking to you next quarter with what we believe will be continued growth in both prescriptions, net sales, and optimizing our gross-to- net. Thank you.