Study Result

Nov 7, 2018

Good morning, and welcome to the Foamix Conference Call to discuss the Phase 3 Results for FMX103. We will open the call for your questions. Please be advised that this call is being recorded at the company's request. For further information related to today's announcement, you may visit the Foamix website at www.foamix.com. At this time, I would like to turn the call over to Mr. Michael Wood of LifeSci Advisors. Mr. Wood, please go ahead. Thank you, operator. Good morning, everyone, and welcome to the Foamix conference call. This morning Foamix issued a press release summarizing the top line results from the recently receive the press release, it's available on the Investor Relations page of the company's website. There are also slides accompanying this call. These can be viewed by logging into the webcast. The link is in the Investors page of the corporate website under upcoming events, and the link is also in the press release. The call is being recorded and a replay will be available on the company's website beginning later this morning. Before we begin formal remarks, let me remind you that some of the information in the news release and on the conference call or webcast contain forward looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words that express and reflect optimism, satisfaction and current progress on clinical data, prospects, projections, as well as words such as believe, intend, expect and similar variations identify forward looking statements, but their absence does not mean that a statement is not forward looking. Such forward looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Several factors that could cause or contribute to such differences are described in detail in Foamix's filings with the SEC. These forward looking statements speak only as of the date of today's press release and call. That's November 7, 2018, and the company undertakes no obligation to publicly update any forward looking statements or supply new information regarding the circumstances after the date of this call and webcast. Leading today's call will be Dave Domzalski, Chief Executive Officer, Phonetics. Also on the call will be Doctor. Linda Steilngold, who is Principal Investigator in Study FX201612. Doctor. Linda Steingold serves as an advisor to the company through a consulting services agreement. She is not receiving any remuneration for her participation in today's investor call. Also on the call will be Doctor. Ed Stewart, Senior VP of Research and Development at Foamix and Alain Hadar, the Chief Financial Officer of the company, who will be available during the Q and A session to answer your questions. So with that, I'd like to turn the call over to Dave Domzalski. Dave, please go ahead. Thank you, Michael, and good morning, everyone, and thank you all for joining our call today as we share the top line results from studies FX2016-eleven and FX2016-twelve, which have been evaluating FMX103 in moderate to severe papulopustular rosacea. And as a reminder, FMX103 is our foam containing minocycline at a concentration of 1.5%. By now, hopefully, you have had a chance to read the press release we issued earlier this morning. We are undoubtedly very excited to announce that both these Phase 3 studies successfully met both of their co primary efficacy endpoints. Additionally, FMX103 also appears to be safe and well tolerated. This is another major milestone for Foamix. We believe that these results together with the expected long term safety data on FMX103 will eventually support a successful new drug application in the United States for this difficult to treat condition. Papillopustular rosacea is a chronic inflammatory condition of the skin that usually first appears in patients in their 30s and in addition to the physical symptoms can cause significant psychological distress for patients. We think the market is considerably underserved and it represents a very compelling commercial opportunity for Foamix. Joining me on the call today to talk about the data and help put these results in context is Doctor. Linda Steingold, who is one of the principal investigators in this program. Doctor. Steingold is Director of Dermatology Clinical Research at the Henry Ford Health System in Detroit, as well as being Division Head of Dermatology at the Henry Ford Health System in West Bloomfield, Michigan. She is a practicing dermatologist, educator and highly experienced clinical researcher, having participated in clinical trials for numerous leading dermatology products. I will hand the call over to Doctor. Steingold for comments once I have reviewed the top line data and she will also be available to answer your questions. So moving on, let me begin with the design of these trials. FX2016-eleven and 12 are identical, double blind randomized vehicle controlled Phase 3 studies. Together they enrolled a total of 1522 patients aged 18 years or older with moderate to severe papulopustular rosacea. Between both studies, subjects were enrolled from a total of 100 investigator sites across the United States. Subjects were randomized 2 to 1 into 1 of 2 arms, FMX103 or vehicle, applying their allocated treatment once daily for 12 weeks. There are 2 co primary efficacy endpoints. These are 1, the absolute change from baseline in the number of inflammatory lesions and 2, IgA treatment success, where success is defined as an investigator global assessment or IgA score of 0 or 1, which is clear or almost clear, and at least a 2 grade improvement or decrease from baseline. Safety and tolerability were also evaluated. In order to be included, patients had to have between 1575 inflammatory lesions and be a grade 3 or grade 4, which is considered to be moderate to severe disease on the IGA 5 point scale. The patient demographics and baseline characteristics can be seen here on Slide 5. In Study 11, the mean inflammatory lesion count at baseline was 28.529 for the FMX103 and vehicle treatment groups respectively. The proportion of subjects with an IGA score of 3, which is moderate or 4, which is severe, was 89.7% and 10.3% respectively in the FMX103 treatment group and 86.7% and 13.3% respectively in the vehicle treatment group. In Study 12, the main inflammatory lesion count at baseline was 3030.2 for the FMX103 and vehicle treatment groups respectively. The proportion of patients with an IGA score of 3, again which is moderate or 4 which is severe, was 86.2% 13.8% respectively in the FMX103 treatment group and 82.9% 17.1% respectively in the vehicle treatment group. Moving on to Slide 6. The results for the first co primary endpoint, absolute change of inflammatory lesion count at week 12 are summarized here. In Study 11, mean reduction in inflammatory lesions at week 12 versus baseline was 17.57 for the FMX103 treatment group versus 15.65 for the vehicle treatment group. This gives you a P value of 0.0031. For Study 12, the mean reduction in inflammatory lesions was 18.54 for the FMX103 treatment group versus 14.88 for the vehicle treatment group. P value here was less than 0.0001. On Slide 7, moving to the co primary endpoint of IgA treatment success. In Study 11, 52.1% of patients achieved treatment success at week 12 for the FMX103 treatment group versus 43% for the vehicle treatment group, the p value of 0.027. For Study 12, 49.1% of patients achieved treatment success at week 12 for the FMX103 treatment group versus 39% for the vehicle treatment group. At the P value of 0.007. On the next slide are the results of one of the key secondary endpoints, which is percent change of inflammatory lesion count at weeks 4, 8 and 12. The percent reduction in inflammatory lesions at week 12 was 64% for the FMX-one hundred and three treatment group in Study 1156 percent for vehicle. In Study 12, the same percent reduction was 61% for FMX103 versus 50% for vehicle. I think it's important to note as you can see from the treatment individual treatment week data, statistical significant differences were determined when comparing FMX-one to 3 treatment groups to the VEGAL treatment groups at all assessed time points in both studies. So we demonstrated statistical significance not just at week 12 but also at week 8 and at week 4 for both studies. A summary of the safety data for non cutaneous treatment emergent adverse events occurring greater or equal to 1% of subjects is presented here on Slide 9. The most frequently reported treatment emergent adverse event was upper respiratory tract infection, which was common for both studies. Serious adverse events for the treatment groups in both studies are summarized here and there were no treatment related adverse events in either study. To summarize the safety findings from these studies, the most common respiratory tract infection, which occurred in less than 3% of subjects in the FMX103 treatment groups. Treatment area cutaneous adverse events in the FMX103 pain, pruritus and hyperpigmentation actinic keratosis. Pain, pruritus and hyperpigmentation actinic keratosis. There were no treatment related serious adverse events in either study. 9 subjects discontinued in total from the program due to an adverse event, 7 from the FMX103 arms and 2 from the vehicle arms. So to summarize, the data from studies 11 and 12 showed strong statistically significant disease improvement of FMX103 compared with vehicle for both co primary endpoints of absolute reduction of inflammatory lesions and IGA treatment success at week 12. FMX103 appears to be well tolerated with an excellent safety profile. In both studies, 112, treatment emergent adverse events were few in type of frequency, most for mild and severity with no treatment related serious adverse events being reported. It is worth remarking at this point that the evaluation of the long term safety of FMX103 is currently ongoing and we expect to report these results in the first half of next year. And now to discuss these results further, I would like to turn the call over to Doctor. Linda Steingold. Doctor. Steingold, please go ahead. Okay. Well, thanks so much, Dave, and thanks for having me today. I work a lot with rosacea patients and this disease has a tremendous emotional impact on these patients. It's one thing to see temples on face of its teenager. But when adults have a face full of pimples, they really feel embarrassed and they feel that they're actually being judged. Our patients are really desperate for new innovations. They desire effective, fast acting and well tolerated choices. Now when I think of topical therapy, I think of it as a marriage between the active ingredients and the vehicle. And both of these components important in determining the efficacy as well as the tolerability of the drug. This is especially important in our rosacea patients because they have very sensitive skin and the drug has to be well tolerated if it's going to be used and it's going to be effective. I've actually personally used this vehicle and the feel on the skin appears to be moisturizing, which is important for managing the dryness and irritation, which accompanies the symptoms of rosacea. So these data actually show what's important to me, which is good tolerability and good efficacy. The hardest endpoint to achieve in doing these clinical trials is actually getting that endpoint of clear or almost clear. This is a very, very high bar. And when we think about patients who come into the study with moderate severe rosacea, we see that in the studies about 50% of these patients achieved the high bar clear almost clear. And this was statistically better than the well formulated vehicle. So this is very impressive considering these patients at baseline had moderate to severe disease. Our patients also think it's important that the drugs act quickly and I was just happy to see that we saw statistically significant reductions in lesions as early as the first time point, which was week 4. Looking at the safety profile, this is very reassuring. The dropout rate due to adverse reactions was low and the tolerability was good. We also have to keep in mind that when we look at clinical trial results, this is for monotherapy and it's to see the drug is only needed to be used once a day. When we talk about once daily application, this is important in my experience for patient compliance. And then finally, topical minocycline actually offers us a novel approach for our rosacea patients and it gives them the efficacy of minocycline without the potential systemic side effects of systemic exposure. So Dave, I'm going to turn it back over to you. Thanks, Doctor. Steingold. And for the audience listening on the call, The next few slides that I want to spend a little bit of time on really highlights, first, where we are on next steps for both FMX103 as well as FMX101, our topical minocycline product for acne. And as you know, we announced very positive results on the Phase III trial for acne just a matter of a few weeks ago. And I also want to talk about how our company now is preparing for its next stage of evolution, which is moving from purely a development stage company to a commercial stage company. But I think before as we start here on Slide 12, let me reiterate, first of all, how thrilled we are with the outcome of these Phase III clinical trials and the potential opportunity for FMX103 now to set what I believe is a new standard in the treatment of papulopustular rosacea. I think Doctor. Steingold alluded to that as well. We are obviously grateful to the patients and investigators who were involved in both of these studies and we plan to continue to share further data from the FMX103 Phase 3 trials as it becomes available over the next several weeks and few months. Take a look at Slide 12 for 101 and 103, but specifically for 103, the next steps for this program include completing our open label safety extension trial. And we hope to have the data for this again in the first half of next year. And this will put us potentially in a position to file an NDA in the United States in the second half of twenty nineteen. So again, just staying on Slide 12, I think we're very fortunate for a company at this stage that we have not just 1, but 2 programs that are completing their Phase III trials, have demonstrated strong clinical efficacy and safety. We are looking at filing an NDA for FMX101, our 4% minocycline foam product for acne by the end of the year. And then for FMX103, hopefully do that in about a year after that. So we could have 2 products sitting down at the agency within a year's time period being reviewed and hopefully approved. So if we then move on a little bit to Slide 13, as I've shared before, this is a very busy and exciting time for Foamix. I've obviously already shared that we reported very positive results from our 3rd and confirmatory Phase 3 trial for FMX101 and modest sphere acne. Again, so we now have positive Phase III data on our 2 most advanced drugs. Both rosacea and acne represent very attractive markets. They're estimated to be more than 16,000,000 people in the United States who suffer from rosacea and between 40,000,000 and 50,000,000 potential acne patients. And despite the availability of various products to treat these conditions, there's been little innovation to address the unmet needs of patients. If approved, both FMX101 and FMX103 will be the 1st commercially available topical minocycline products ever. And I believe both of these products can provide significant benefits to patients. If we stay here on Slide 13, I think it's important to know a couple of key points for us as an organization. 1st and foremost, we have the experience in commercializing products. I think you should see it from this slide, although there is a variety of different components, a lot of the work is already being done. We certainly know the importance of the reimbursement landscape. We are in the process of executing on our pricing of patient assistance programs, contracting distribution and the appropriate market research in that space. We already have begun our medical communications efforts. We have our scientific message platforms in place. We believe we have great data to talk about at the platform at Congress's conventions over the course of the next 12 to 18 months, where we will highlight our efficacy and safety data, obviously the importance of our vehicle. And we have a strong publication plan laid out, which is beginning as we speak. We've already outsourced and selected our agency partners for medical education, advertising, market access and data. I think the key thing here is having launched several drugs in dermatology, we could do this quite efficiently and quite cost effectively. We don't have to bring in legions of people into the organization. It's an inefficient way to launch products in this category. We have great partners that can help us do this efficiently. I think if you look at the upper right hand corner of Slide 13, our years of experience in launching products speaks for itself. I have on this slide alone just 8 products that myself and the team have experienced launching or have successfully launched these products. I personally have done this over the course of 10 years. Unlike a lot of stage companies like ours, clinical stage companies that have very strong science background in their management team, we have that. But we also have very strong commercial experience, including myself. So we clearly know how to launch drugs in this category. We knew how to do this effectively and successfully. And I think lastly and most importantly, we're well capitalized. We have the cash to do this and to get this done. Moving on to Slide 14 in terms of the market opportunity. As I shared before, these are big opportunities for us. This slide just shows some of the recent product launches that have taken place in acne. So these are the QD dose for Axsome, Epiduo Forte, and Nextin and Retin A. And if you take a look at on this slide, just where we have it circled, that gives you the average prescription volumes over the last quarter of data that we have in the 1st year of launch. It's just the 1st 12 months of launch. You can see if you actually take all these products, whether it's Axone, Epiduo, Nexa Retin A, average them up and that's about 25,000 prescriptions per month. I've also provided what the current WACC price is for these products. So you can really apply whatever price point you deem is appropriate, but if you just apply that to an average of 25,000 prescriptions per month as exit run rates in the 1st year of launch, I certainly look at this as significant opportunities for us and I'm quite confident in our ability to be in the range of these products. We move on to Slide 15. This gives you the same view, but in the rosacea marketplace. The orange line is Oracea, which is branded oral doxycycline. You have SULANTRA and also FINACI foam, which is our foam platform. And again, you can see the average prescription volume, the last quarter of the 1st month of launch is also again around 25,000 prescriptions. I provided the current lag prices associated with that. So we view that both of these categories, acne and rosacea, are underserved, significant upside potential and we believe that based on the efficacy and safety data we've demonstrated for both of these programs that we are confident we can have significant market share and revenue projections for these products. So as we wrap up here, and then before that, I'll and then after this, I'll open up for questions. For myself personally, it's been 4.5 years since I joined Foamix. And over that time, I've watched the company make enormous progress and mature to the point where we have executed on our late stage programs and are now preparing NDA submissions in 2 major dermatology indications. I'm incredibly proud of the team of professionals here at Foamix. Their dedication to new technologies and science and to the dermatology community and what they have been able to accomplish in a relatively short period of time. As we prepare our regulatory submissions, we will continue to progress our plans to bring these products to market and advance our pipeline, which I look forward to providing more details on soon. So that concludes our prepared remarks. I would now like to open the call for questions. So I'll turn it back to the operator. And we will take our first question from Ken Cacciatore with Cowen. Please go ahead. Your line is open. Great. Thanks so much. Congratulations on the data. I had a question actually for Doctor. Steingold, if she's willing to answer. I was wondering if she could give her thoughts on the absolute magnitude versus the delta with the vehicle. Understanding you said that the vehicle you've used it and it seems to maybe have a really nice qualities and moisturizing. Can you just talk about how we should interpret that data, the absolute versus the delta between vehicle? And then secondly, was hoping Doctor. Steingold, you could just walk through the typical treatment paradigm for rosacea. How exactly this product would fit? And then maybe lastly, what percent of patients do you think this would be used in percentage of your patients? Thank you. Sure. Thanks a lot. Basically, to talk about the difference between the active and the vehicle, again, I think that the vehicle component, especially for a rosacea treatment is critical, because the number one problem I have with my rosacea patients is that often topical therapy can be irritating. They have a side effect, they stop their medication. So it's important that the vehicle be formulated to actually add to the overall complete product of the topical. So I'm actually happy when I see some of the vehicle effect. With rosacea, a lot of the treatment actually comes down to barrier repair. They have an abnormal barrier. They have what we call increased trans epidermal water loss. Their skin is a little bit leaky. It's inflamed. It's very sensitive. So we often rely on the vehicle to help out in that component of the treatment. So we want them to kind of use basically gentle cleansers, moisturizers and hopefully a product that actually adds to the efficacy not only the vehicle effect, but also the active effect as well. When we look at the IGA or the investigators global assessment, we see that the delta between the actives and the vehicle is about 10%, which is pretty strong. These are both statistically significant results, which is quite a good delta. So although the vehicle helps, the active significantly helps more. So I think this is pretty powerful. And you can't just buy the vehicle over the counter. This has been formulated, it's proprietary, it's part of this particular product. And when we look at the product as a whole, we're seeing that about half of these patients are getting to the clear, almost clear. And that bar is exceptionally high. That's basically standing and looking at a patient at arm's length and saying, how many of you went from like 30 bumps on your face all the way to clear, almost clear with one drug once a day. So given that, we do study this in clinical trials, which means it's monotherapy. In real life, this goes into our basket of treatments for rosacea patients. Technically on label, at this point it's a monotherapy drug because it hasn't been studied in combination. I will tell you in real life what dermatologists do is they take all of their products and often they mix and match drugs that have different mechanisms of action. We have used oral antibiotics for rosacea very, very commonly. They're used as oracea, but they're also used off label as systemic therapy for both minocycline and doxycycline. So the fact and they're very, very commonly prescribed as oral therapy. So the fact we now have a topical that gives us this quality of results without having to go to a systemic antibiotic is really quite promising. I don't know if I hit all your points. Just lastly, any thoughts of maybe percentage of your patients as you think about different rosacea patients? I'm sure they present differently. What percent of patients you think this product could touch? There's not a rosacea patient that would not be appropriate for this particular drug unless they had an allergy to minocycline. So it could it has the potential to be used in every rosacea patient. How will it be used? I think people will be impressed by looking at the data and to be honest, only time will tell. But there's no reason somebody wouldn't reach for this as opposed to reaching for a systemic agent. I think it makes sense to reach for this first before going to an oral agent. Great. Thank you. And we will take our next question from Vamil Divan with Credit Suisse. Please go ahead. Great. Thank you so much for taking the questions. I guess, mine also sort of follows on the comments from Doctor. Steingold and then maybe one for the company. So just in terms of Doctor. Stengel, curious, I think in the acne market, we hear a lot about payer pressures and the need to use generic medications before getting to the branded side. I'm curious if you could just talk about your perspective in the rosacea market and how much pressure do you see from payers in terms of what you're allowed to prescribe? And then second one would be for the company. You mentioned well capitalized to support the launch, but maybe you can just remind us of your cash position now and thoughts on the need for additional financing prior to launch of either of these? Thank you. Okay. So I guess I'll start. This is our world right now. We have pressures to use generics. We have pressures not just in rosacea and acne, but in everything that we prescribe. So the doctor has to have a reason to prescribe a branded product. So this gets harder when we're talking about just reformulations of existing products. Now you don't necessarily want to sit on the phone and fight for a branded that might just be a reformulation. But we're actually talking about a different class of drugs now for the treatment of rosacea. We have not had a new topical antibiotic drug in a very, very long time. And so the fact is, I think people will be willing to fight to say, look, I don't want to give my patient a systemic antibiotic. I want to have the option of giving them a topical that has proven efficacy. The numbers are very, very strong. So I think in this case, many doctors will take the time to fight to get this particular branded product. Thanks, Linda. And then I'll just follow-up on Doctor. Steingold's comments regarding the payering and then I'll turn it over to Lon, our CFO that can talk about cash. We've conducted extensive research for both acne and rosacea. We're clearly aware of the continuous reimbursement pressures in these categories, but for that matter in all therapeutic classes, it's just our world, if you will. We believe from our discussions that we have clinical relevance for our product to be reimbursed, the payers that we've talked to reinforce that. And I think also as Doctor. Steingold has alluded to, we would be the 1st topical minocycline for the treatment of acne and rosacea that's ever been available on the markets. The price points for topicals, and we have obviously not announced a top price point for us, would be significantly less than the oral therapies that are currently available and that bodes well for us. So we believe from the research we've done, we've got strong clinical messages and we certainly know what our value proposition is relative to the other therapies that are currently available. And we feel quite good about that. As we move down the line and get closer to launch, obviously, we'll provide more color and insight on that. But as I already alluded to, a lot of work is well underway. So I believe we're ahead of the game. So I'll turn it over to Ivan that could talk about our cash position. Thank you, Dave. So following the follow on equity offering in September where we raised $76,300,000 net, We have in the bank right now over $100,000,000 I do not anticipate that we will have to do any offering in the near future. We do have enough cash to finance our operations until mid-twenty 20, including as we communicated in the past, the full development and filing of an NDA for FMX101, the same for FMX103 filing the NDA during 2019. We will commence our pre commercialization and launch preparation for FMX101 during 2019 and we'll continue developing certain pipeline activities of the company. So I think the main takeaway message is that we do not anticipate to do any offering in the near future and we do have enough cash at the current time. Yes. I think just to follow-up on the last comments. Obviously, the biggest spend when launching products often is sales force. And I think a couple of key points of note. One is, unlike other arenas, other therapeutic classes, you do not need a large field force or sales force footprint between 5,001 100 representatives. I've said this many times, 60, 70, 75 generally is the sweet spot. That's also one of the last things that you bring on board. There's no reason for us to bring on a sales organization until we get towards the PDUFA. So we could be very, very efficient in our cash burn over the course of the next year and a half. As Lon said, we've got sufficient capital to get us to mid-twenty 20, so well within the range to go ahead and launch these products. So we feel quite good about doing this. We don't need large sales forces to do this. It will be very, very efficient. I've said before, there's about 15,000 dermatologists in the United States. About a third of them generate about 80% of the prescription volume. So it's very targeted. So we feel great about our position for this. We know how to launch products in the category. And I think the last point too is unlike other recently launched products in the derm realm, where there's been significant capital spend to build markets, create awareness in the various categories of products that we launched in. We do not need to do that. Acne is a very well defined category. Rosacea is a very well defined category. Doctor. Steingold, I think, alluded to it quite perfectly. What we do have to offer are what we believe are significant advances and new options for physicians and for patients. So we can focus on the benefits of our products, not having to spend enormous amount of resources educating physicians and payers on a particular product or a particular category. Okay. Thank you so much. You got it. We will take our next question from Louise Chen with Cantor Fitzgerald. Please go ahead. Yes. Thank you for taking my call and congratulations. This is Sudan in for Luis. So I had a quick question about Study 11. I noticed that the P value was not as robust, statistically significance versus the Study 12 and the IGA score analysis. And I was kind of wondering what was the if the patient breakdown of moderate to severe rosacea patients kind of may have an effect on that and kind of what was the breakdown of the severe moderate patients in that group specifically versus Study 12? And then like what is the design of the long term safety study and any additional efficacy data that can be gleaned from that? I'll turn it over to Doctor. Ann Stewart, our Head of Research and Development that obviously Randy studies. Thanks for your questions. I think it's speculative to suggest that those particular factors could influence that because obviously there is a slight difference in sample size, but we're talking about a difference of 20 patients here and a population size in excess of 1500. So the statistical test here is to ensure that by at the 5% level that we had a significant difference in both IgA and lesion count. So we met that by quite some margin. I think when you look at the baseline severities here, I think we have pretty much similar to what you would expect in any product in the category. Certainly encourage everyone to look at the corresponding product labeling for these types of products. This is a pretty typical profile you would expect to see for subjects moving into a moderate to severe rosacea study, pretty well balanced across both studies and all four arms in our opinion. So I don't think there's anything here that can, if you like, explain slight differences in P value. The key message here is that we did see statistical significance. In relation to the open label safety design, it's a very similar design to our acne open label extension from our 4 and 5 studies reported in the past. This is PRN study. So subjects can stop and start therapy based on their clinical response in collaboration with their corresponding investigator. Clearly, if someone is clear, it doesn't make sense for them to continue in therapy. They can use clearly if they flare up, they can recommence therapy. They can use other combinations, concomitant medications that may be appropriate at the physician's discretion. We did assess or we are assessing open label efficacy as well in a very similar way to what we did with acne as well. And we will communicate that information along with the, if you like, the primary purpose of the study is to evaluate the long term safety. Yes. This is Dave. I'll pop up on a couple of points. I think, one, what we've seen in our studies is when we take a look at safety and thinking through the effect of the drug, we had a significant rollover of patients from the double blind portion to long term safety, significantly low dropout rate. So the number of patients or the percent of patients that wanted to rollover out of the double blind portion of these studies into long term extension was very high. I think as you recall, we actually announced that we had stopped rolling patients over into the safety study before we completed enrollment of the double blinded efficacy of these studies. So I think that goes to an overall high level of satisfaction with the product. I think we've seen in our safety data, again, appears to be a very clean, very well tolerated product. Again, coming back to the IGA, these are strong STAT SEG results. Doctor. Steingold also framed I think quite well. We're looking at basically 1 of 2 patients enrolled in the study that's on active reaches treatment success after 12 weeks. And that's clear or almost clear. So again, you're talking patients that have 30 lesions roughly on average to start and after 3 months, they're basically gone. We have a vehicle that is proprietary, works very well. We see that. We've seen this in our acne studies. But again, I think Doctor. Steingold framed it very nicely. Our vehicle is part of the overall finished product that we will be bringing to the marketplace. So and when you take a look at then the significant additive effect of adding a highly effective active hearing minocycline, that's ultimately what the patients are going to have. So our vehicle, we've always been quite proud of it. It's what's enabled us to do something no one's been able to do, which is to put this very, call it, fickle antibiotic that's that degrades quite rapidly in other topical regimens. We have a in our topical foam formulations, we have a physically stable, cosmetically appealing product that obviously we seem to be showing quite substantial efficacy and safety, whether it's in rosacea or in acne. Okay, thanks. Got it. And we will take our final question of the day from Patrick Dolezal with LifeSci Capital. Please go ahead. Hi, thanks for taking the questions. I think most of mine have been answered, but perhaps you could just provide a little additional color on the AEs causing the discontinuations in the 103 arm. And then maybe just give us your thought process and how you think about some of these challenges commercializing a product as a small spec pharma company kind of in comparison to partnering with a larger organization? So I'll turn it over to Ian first to address the discontinuation rates. Yes. Discontinuation of the 7 versus 2 here, obviously, that's across the entire program, all 1522 subjects. We don't have the data yet about causality. I think that's probably what you're most interested in. It doesn't necessarily mean that 7 of those subjects within this FMX103 treatment arms had adverse events related to medication and subsequently discontinued. It's just they discontinued for an adverse event. So we will obviously provide more information a little bit later on when we have that information. So really not much more to comment just now. Patrick, addressed your question around commercializing versus partnering, a couple of thoughts. Again, this is a very large commercial footprint sales force is very large commercial footprint sales forces as we talked about before. This was a category that we did not have experience in. It may be a different story, but we have significant experience in launching products, myself personally, as well as the staff and the team that we have here. We came to this company to develop and ultimately bring to market these products. We know how to do this. We've done this quite successfully. It's again not a category where we need to build the markets or we need to educate the physician and patient base on a new disease state. This is a well known, well defined disease state, whether it's rosacea or acne, that has significant unmet needs. And we believe that our product is going to address many of those unmet needs. And I think lastly, the idea of just partnering, I always take the approach of if you own it yourself in terms of the products, I'm always one that you get to control your destiny if you own it versus having a co promote and somebody else having to do that. I've been involved in those. There's lots of challenges when you get in those types of arrangements. We've always said that we have no hesitation to launch these products ourselves. We're focused on doing this as we transition from a clinical stage to commercial stage company. We have the wherewithal, the experience and resources and the cash to do that. And I'll leave it at that. Great. Thank you. And we have no further questions at this time. I'd like to hand it back over to management for any closing comments. Thank you, operator, and thank you again to everybody on this call for joining us today. As a reminder, we will be holding a call to discuss our Q3 financial results tomorrow at 8:30 am Eastern Time. And we also plan to hold a, call it an R and D day for the investment community in the near future. This will provide the opportunity to interact with some key opinion leaders in dermatology and to learn more about the landscape and opportunities in acne rosacea as well as some further insight into our pipeline activities. We'll let you know the actual date soon. It will likely be sometime in December, and we look forward to speaking with you and seeing you then. So thanks again everyone for joining this call, and look forward to speaking with you tomorrow. Have a good rest of the day.