Good morning, welcome to the Menlo Therapeutics conference call to discuss the serlopitant phase III results. At this time, all participants are in a listen-only mode. Following the company's formal remarks, we will open the call for your questions. Please be advised that this call is being recorded at the company's request. I will now turn the call over to Michael Wood at LifeSci Advisors. Please go ahead, sir.
Good morning, everyone, and thank you for joining us today. Before we begin the formal remarks, let me remind you that some of the information in the news release and on this conference call contain forward-looking statements that involve risks, uncertainties, assumptions that are difficult to predict. Words that express and reflect optimism, satisfaction with current progress, prospects for projections, as well as words such as believe, intend, expect, plan, anticipate, and similar variations identify forward-looking statements, but their absence does not mean that the 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 Menlo Therapeutics' filing with the SEC.
These forward-looking statements speak only as of the date of today's press release and conference call, 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. At this time, I'd like to turn the call over to David Domzalski, Chief Executive Officer of Menlo. Dave, please go ahead.
Thanks, Michael. Good morning, everyone. This morning, we issued a press release with the results of the NEULARIS phase III clinical trials, which have been investigating serlopitant as a treatment for pruritus or itch associated with prurigo nodularis, or referred to as PN. Unfortunately, the primary endpoint in both trials was not met. We did see numerically higher scores for the active treatment arms compared with placebo, but these differences were not statistically significant. As a result of this outcome, we've made a decision not to develop serlopitant any further. On the call this morning, I want to spend a few minutes talking through the phase III results and then provide a brief update on our business and our priorities as we move forward developing our commercial products.
Joining me on the call this morning is Dr. Iain Stuart, our Chief Scientific Officer, Andrew Saik, our Chief Financial Officer, and Matt Wiley, our Chief Commercial Officer. They will be available to answer questions during the Q&A session. The studies MCI-105 and 106 are identical phase III multi-center placebo-controlled double-blind trials that were designed to enroll patients with a clinical diagnosis of PN who experienced pruritus for at least six weeks prior to enrollment. Additionally, patients should have a minimum of 10 prurigo nodularis lesions on at least two anatomical areas, and the pruritus they were experiencing had to be directly associated with PN. To be enrolled, patients were required to have a worst itch numerical rating scale score, or WI-NRS, of at least seven at screening and a minimum weekly average of 6.5 for each of the two weeks prior to randomization.
Study 105 enrolled 285 patients in the U.S., and Study 106 enrolled a total of 295 patients from Germany, Poland, and Austria. The primary efficacy endpoint for both of these trials is a four-point reduction in the patient's Worst Itch Numeric Rating Scale, or WI-NRS, at week 10. In Study 105, 26.5% of patients in the serlopitant group achieved a four-point or greater improvement on this endpoint at week 10 compared to baseline versus 20.3% of patients treated with placebo. The p-valu e was 0.229. In Study 106, 25.9% of patients in the serlopitant group achieved a four-point or greater improvement compared with 18.95% of those patients on placebo. The p-v alue was 0.158. The primary endpoint analysis was based on the intent-to-treat population with multiple imputation as the primary method of handling missing data.
You will appreciate that after we received the data, we performed additional sensitivity analysis in order to understand the results better and see if there was a treatment benefit if we analyzed the data in different ways. We examined the Worst Itch Numeric Rating Scale changes over 10 weeks using different analytical populations, statistical methods, and method for handling missing data. These included per protocol, last observation carried forward, and repeated measures methodologies. Again, for each of these analyses, a numerically higher percentage of patients in the serlopitant treatment groups achieved the four-point reduction in Worst Itch Numeric Rating Scale compared with the corresponding placebo treatment groups. There was no statistical significance in any of the conducted sensitivity analyses. The trials were designed with a number of secondary endpoints, and we have been analyzing these data also.
One of these was the change in weekly average Worst Itch Numeric Rating Scale scores over time. On this endpoint, for both studies, we saw a numerical advantage of serlopitant treatment in reducing weekly average WI-NRS scores versus placebo for all assessed time points. This began as early as week two. Once again, statistical superiority was not observed for any of these intra-weekly comparisons. We have also looked at patient characteristics at enrollment, both in terms of demographics as well as severity of symptoms on study entry in order to understand if there were any differences between treatment groups that might help explain the outcome. The treatment and placebo groups were well-matched for parameters such as age, sex, and ethnicity.
Importantly, the Worst Itch Numeric Rating Scale weekly average scores at baseline were highly consistent between all treatment arms. With an average baseline score of approximately 8.5 on a scale of zero to 10. Regarding safety, serlopitant was generally well-tolerated, and the safety information gathered from both phase III trials is consistent with prior experience from the clinical development program. Obviously, these results did not meet expectations, as I shared, we will not be making any further investment in serlopitant. Business development, particularly around pre-commercial assets, always carry a certain amount of risk, certainly in biotech. As Foamix and Menlo were negotiating the terms of the merger in 2019, we were clearly planning for success. We were also careful to structure the transaction in such a way as to protect shareholders.
The merger closed on March 9th, at that time, Foamix shareholders received 0.5924 shares of Menlo common stock for each share of Foamix they held at the closing. They also received contingent stock rights that would convert into additional shares of Menlo common stock, depending on different scenarios related to the serlopitant phase III outcome in PN. As we are announcing today, neither of the phase III trials met their primary endpoints. Given this outcome, each CSR will now convert into an additional 1.2082 shares of Menlo. The result of this is that legacy Foamix shareholders will own approximately 82% of the outstanding Menlo shares as of the closing of the merger. For additional details on these CSRs, I would refer you to the press release we issued this morning, as well as Menlo's filings with the SEC.
The other important benefit of doing this merger was that the combined entity provided for a stronger balance sheet than either of the predecessor companies had independently. As stated earlier this month, we believe our current cash position will be sufficient to support operations into the second quarter of 2021. Despite today's news, our mission at Menlo remains very much intact, and that is to build a successful franchise of dermatology with multiple commercial assets, and in doing so, create value for our various stakeholders. We launched AMZEEQ as treatment for acne at the beginning of the year and are encouraged by positive reception from both physicians and patients. Additionally, we have a PDUFA date coming on June 2nd for FMX103 in rosacea, and assuming a positive decision from the FDA, we expect to have two commercial products on the market by the end of this year.
With the near-term prospect of a second product launch and considerable overlap in the target positions that treat acne and rosacea, we continue to see an opportunity to create increased operational leverage for the company. Our sales team, comprised of 51 representatives, was trained and certified at the AMZEEQ launch meeting held in early January and began selling on January 13th. We've been very pleased with the initial rollout and saw a strong increase in weekly prescriptions through early March, with total prescription volume reaching over 18,000 within just 10 weeks of launch. Obviously, the situation with COVID-19 has changed things somewhat. Like most of our peers in healthcare, it's inevitable that there's going to be a slowdown in the momentum. Our sales representatives, however, are completely focused on staying connected with healthcare providers and are, of course, taking necessary precautionary steps in their interactions.
Given that face-to-face field activity has been suspended, our reps are now taking advantage of digital tactics and virtual meetings to remain engaged with physicians. It's difficult for us to predict exactly when the current situation is going to be resolved, but we are confident that there will be a recovery at some point and that our business will get back to normal. There remains a very significant unmet need in acne and rosacea, and AMZEEQ, as well as FMX103, are differentiated products with a very compelling therapeutic profile. Despite the current economic slowdown, we continue to see positive momentum in our discussions with payers. The payers are open for business virtually, and we are active in our efforts to secure additional access and negotiate contracts.
As stated in the past, our strategic objective has been to secure contracts with the majority of key payers by the end of second quarter or early third quarter of this year. The upside is that once the economy regains momentum, we anticipate having to absorb the cost of fewer prescriptions through our co-pay card program, as more will be covered through patients' insurance plans, and hence, we will be able to get more fulsome value for new prescriptions. Before I close, I would like to take this opportunity to thank the patients and their families who participated in the Phase III serlopitant program, as well as the investigators, nurses, and other healthcare professionals who were involved in these trials. We are grateful for their interest and commitment.
In closing, our vision has been to create a scaled business in therapeutic dermatology through the development and launch of innovative products to address unmet needs of patients. Though today's results for serlopitant are disappointing, it has not changed our goal, our focus, or our vision. We believe our initial strong launch efforts for AMZEEQ reflect the merits of the product and the execution of sound commercial strategy, which we intend to replicate with the launch of FMX103 in rosacea when approved. We plan to deliver on these goals while ultimately building long-term value for our shareholders. That concludes my prepared remarks. I'll turn it back to the operator, as we are now ready to open up the call for any questions. Thanks.
Thank you. We'll now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 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. One moment please while we pull through your questions. Our first question comes from the line of Louise Chen with Cantor. Please proceed with your question.
Hi. Thanks for taking my questions here. I had a few questions. First on AMZEEQ, can you provide any color on the launch and physician feedback?
If there has been any impact from COVID-19 yet on your launch here. The second question I had was on the approval for FMX103. Will there be any potential delays as a result of the pandemic? Last question is on serlopitant for psoriasis. Will you still pursue this product, or are all these serlopitant assets kind of moved aside right now? Thank you.
Thanks, Louise. I'll take the last one regarding serlopitant for psoriasis. Obviously, as everyone knows, we had conducted a phase II study for pruritus associated with psoriasis some time ago and got good results. As I alluded to in my opening remarks, at this time, our focus is going to be on the launch of AMZEEQ and what we would hope to be an approval, and then the subsequent launch of FMX103. That is where our focus is right now. We are not putting additional development efforts or resources behind serlopitant. With that, I'll turn it over to Matt to provide some color on the initial uptake from the launch of AMZEEQ and physicians' reactions. Matt, you want to take that?
Sure. Thanks, Dave, and thanks, Louise, for the question. If you've been following the weekly TRX and NRX trends, we've seen quite robust uptake. As Dave mentioned, we had over 18,000 TRXs, almost that number in NRXs, for the first 10 weeks of launch. We have seen a bit of an impact over the last couple of weeks. We did see NRX and TRX decline. When we think about COVID-19, there are really three things that are impacting the market. You have patients that aren't necessarily seeking treatment. You have physicians who are closing their doors for non-essential patients, and so acne may fall into that category. Our sales team, the last couple of weeks, has been working remotely. Of those three things, we can really impact the last, and so that's what we've done.
We've pivoted to remote detailing, lunch and learns, speaker programs, things of that nature. We've reimagined all of the assets that they had in the field for virtual use. We've seen some early signs that they've been able to have some impact. We actually saw the number of details increase last week versus the prior week, which is an encouraging sign. There has been a bit of an impact. We would expect that throughout all business, not just in pharmaceuticals, that there'd be an impact based on those factors. We are encouraged by some of what we're hearing from the field and some of what we anticipate will be phy sicians also reimagining how they do business through telemedicine and others. So far, the feedback that we've gotten from our reps and from physicians has been very positive.
Yeah, thanks, Matt. I'll just echo Matt's thoughts. Obviously, we were thrilled, and are thrilled, with the initial uptake for AMZEEQ. As we talked about before, our prescription trends were literally tracking at the same level as what we saw with Almirall's product, SEYSARA, a year ago the same time, which is an oral antibiotic. We obviously are very encouraged by the initial uptake. Obviously, not unlike any other business right now, COVID-19 is having an impact. Our focus is to do what we can from a virtual perspective to continue to drive momentum as much as possible and be ready once the offices open back up to continue with the trajectory that we've seen prior to where we are right now under this current global pandemic. Coming back to your question, Louise, on FMX103. We've had fluid discussions with the FDA.
Since we had filed the NDA, we have our PDUFA date scheduled for June 2nd. We're obviously quite far down the line in the review process. We have not received any signs or any indication that the PDUFA date is at risk from June 2nd. As I sit here today, things continue to be on track. The dialogue with the agency continues to be fluid. Any requests, we believe we've been able to provide the information to the agency quickly and according to what their requests have been. Again, I'll just reiterate, right now, we've not heard anything to suggest that the PDUFA date of June 2nd would be in jeopardy.
All right. Thank you.
Got it.
Thank you. Our next question comes from the line of Ken Cacciatore with Cowen and Company. Please proceed with your question.
Hey, guys. Sorry about this news. Just had a couple questions. First, I know this is going to sound overly simplistic. Can you just help us with what the share count now is for the company post adjusting for the news here? Also on cost, I know that you're running down the Menlo, obviously, cost structure. Can you just talk about any other thoughts you have as you think about COVID-19 and impact on the business, how you can adjust maybe the cost structure of the company for what we all hope is just a temporary pause? Lastly, obviously, can't drop samples, or I'm sure sampling is becoming very difficult here. Can you just talk about how you're adjusting in terms of maybe couponing and ensuring that patients have access during this time? Thank you.
Yeah. Thanks, Ken. Andrew, why don't you take the first two, if you don't mind, and then, Matt, I'll have you speak regarding how we're handling samples with physicians.
Yeah, no problem, Dave. Thanks for the question, Ken. As you know, and as has been disclosed in company filings in the 8-K that we did this morning all Foamix shareholders of record as of the merger date are now entitled to an additional 1.2082 shares.
Those are going to be issued as soon as practical by our exchange agent. We expect that once that is done, our shares outstanding will be in the neighborhood of 136 million shares. As far as costs, the company had a plan in place prior to this to consolidate operations with Menlo. We don't see a significant change to our plans based on this outcome. Like all companies, we're always going to be looking to save money where we can and run our operations as efficiently as possible. Given the plan that we already had in place, this doesn't represent a big change. We still have a cash runway into the second quarter of next year, and we're going to be just focused on running the business as efficiently as we can.
I'll hand it over to you, Matt, for the next question, Ken, unless you have a follow-up.
No, thank you. That's great.
All right. Thanks, Ken, for the question on samples. We're doing a couple things. One is we established what we're calling a curbside sample drop program, where physicians are still in their practice and want samples. They can contact the rep, and the rep can deliver them basically curbside as you would any other delivery. Either meeting them at the door or out in the parking lot, whatever the case may be, to get them the samples they need. We're also looking at a direct HCP sample program. It's a little bit more time to get something like that set up.
The other thing to keep in mind is that as physicians are reimagining how they're dealing with acne patients, telemedicine is really the first opportunity because they can either see the patient symmetrically via FaceTime or via some type of webcast service, or asymmetrically by looking at patient pictures, et cetera. As they're prescribing drugs for patients in that environment, those patients are going directly to the pharmacy to fill prescription. They're not using a sample to get started. We would expect that samples will become, at least for the next few weeks, less important as a driver for those patients as physicians are using telemedicine to diagnose and prescribe drugs.
Yeah, thanks, Matt. I'll just offer a few additional follow-up points to that. Obviously, if there's less sample utilization, that's certainly a net positive to the balance sheet for us. Not like any other company, we're in this environment where people are home and including that, though, are the patient population where prevalence of acne is most profound. High school-aged patients and college-age patients. One of the thoughts that we're obviously monitoring closely is dermatologists or the derm community, they are obviously looking at ways they can continue to sustain their businesses. Since they may not be having patients come in their office except for emergencies, patients that have conditions such as acne or rosacea, as Matt alluded to before, are quite easy to diagnose from a telemedicine perspective. We're obviously seeing that happening, and we're monitoring that quite closely.
We are looking at there could be a bolus of patients out there that are now home, that are candidates for acne treatments. Whether it's now through telemedicine or as soon as the offices open up, there could be a bolus of patients that are coming in to seek treatment. That's why we're obviously staying quite close to our healthcare providers and the engagement that the reps are having virtually, so we could take advantage of that as patients are seeking treatment, as they call their offices to get treatment, and then going to the pharmacies. We can look to potentially capitalize on that.
Great. Thanks so much.
You got it.
Thank you. Our next question comes from the line of David Amsellem with Piper Sandler. Please proceed with your question.
Thanks. I had a longer-term question. Obviously right now the field force is not in the field and there's more remote work being done and you're doing more digital initiatives. I wanted to get a sense from you as to potential permanent changes in the promotional landscape where the sales force does more digital initiatives and less face-to-face interaction and the extent to which that impacts AMZEEQ in acne and rosacea, either good, bad, or net neutral. How do you think about that?
Hey, David, I'll offer some initial thoughts, then I'll turn it to Matt. One of the things that we're looking at, not just in the sales organization, but for our entire company is, what are the pearls that one could take from this current environment that change the way we operate business on a go-forward basis, and where we can operate more efficiently? I think that's certainly the biggest thing that I look at is when you're in times like this, you are forced even more so than ever to look at how you get more out of less. I think on a more macro basis, I think, virtual meetings, telecoms, digital utilization of interactions will become more and more the norm. I think we're seeing that right now.
Perhaps people are hesitant or are not as quick to jump on a plane for a meeting in Columbus, Ohio for four people at an agency because you can just be more efficient in running your business from a telemonitor back home. I think when we look at the sales force, we're seeing initiatives that the team has put together that I would believe will have a permanent net positive impact on how commercial businesses operate. Matt's alluded to some of them. These virtual interactions, these virtual speaker-based training programs, which can be ultimately much more efficient. I think one of the things that we're also finding, and Matt provide some more color, is that in these tele details, virtual exchanges with a representative and a healthcare provider, although there may be less frequent exchanges, the duration of those exchanges are clearly longer.
An opportunity to expand and extend the relationships with that healthcare provider. I mean, think of it this way, if that healthcare provider, that physician, is willing to conduct a virtual session, FaceTime, with a representative, a marketing manager on the other end of the line, you get complete attention from that person. It's no different than our exchange right now on this call. You get complete attention and engagement with that person, which as we all know, is a bit different from the normal routine of sales calls in a face-to-face setting, where you're navigating through the offices, patients in the waiting room, trying to get time with the physician, going from office patient to patient. Although maybe the number of exchanges are less frequent, what I anticipate we'll continue to see is that those engagements are certainly more durable.
Building or improving the relationships, which ultimately should help us when the doors open and everybody's back out in the field. That's my initial thoughts. I'll turn it over to Matt for some additional color.
All right. Thanks, David. Thanks, David, for the question. One of the things that we've observed over the last couple of weeks is that for those physicians who are in more distant locations from the rep's home, so four or five hours away, for those physicians who might be in white space, who are still valuable potential customers, we've been able to access those physicians through digital means. Rather than, as Dave alluded to, getting on a plane and flying to meetings or in a rep's case, getting in a car and driving four or five hours, it's a very efficient way to establish a relationship, number one, establish some habit, number two, and then maybe make those trips less frequently as a third opportunity. The other thing too is that when we have speaker programs, typically your speakers would fly into a city.
If folks who might want to hear that physician speak live don't have that opportunity from the digital platform, and we had a handful of these last week, we've got several more over the next couple of weeks, where we're seeing our key opinion leaders speak on AMZEEQ, and we're drawing in physicians who might not otherwise be able to attend a live meeting. These changes, I think, are durable changes that we can continue to leverage on a go-forward basis and make us more efficient.
That's helpful. If I may just make in a follow-up. It sounds like if I'm paraphrasing you correctly, that there's a net benefit to the cost structure that should endure. Number one is, am I correct in making that characterization? Then number two, is that a large net benefit? I know it's hard to quantify that, but is that a large net benefit or is that something that you envision will be more modest over time?
Yeah. It's probably tough to answer, David, in terms of giving a hard number on it, right? Because this is fluid. We're a couple of weeks into this global pandemic. Obviously, we're responding accordingly and looking for opportunities to run a more efficient business wherever possible. To quantify if it's a net significant benefit or net modest benefit, our hope is that we can provide more color on that as we move to over the course of the next couple of weeks and months. I do believe firmly, that this current global pandemic is allowing us, as well as other companies, to identify ways to run our business more effectively and more efficiently. I think that's just the nature of who we are as a business and who we are in our society here in America.
Okay. All right. Thanks, guys.
You got it, David.
Thank you. Our next question comes from the line of Jason Gerberry with Bank of America. Please proceed with your question.
Oh, hi. Good morning. This is Shane for Jason. Thanks for taking our questions. I guess the first one is, just want to follow up on the telemedicine. I just want to confirm that a rep can initiate a or a physician can initiate a new prescription through telemedicine that a face-to-face appointment is not required. I guess the second question from us will be, if we look ahead, maybe a few months further down the line when social distancing eases, maybe can you talk about how you envision the launch activity involved? Just curious, do you think this is going to go back to business as usual right away? Do you think there might be a constraint to physician bandwidth for some period of time and how Menlo Therapeutics is expecting to work through that process? Thank you.
Yeah. I'll take the second question, then I'll turn it to Matt and Iain for any thoughts just on telemedicine. Shane, the short answer is, I think the state and local authorities will ultimately dictate our response. If this is likely, I would suspect that it'll be a phased approach, that as the various areas around the country as shut-ins are lifted and restrictions are lifted, we'll respond accordingly. That's the best that we can do. That's what we're doing right now. I do think to your first point of that question, obviously, we're eager to get back and engage with customers on a face-to-face basis. That's obviously the nature of our business, but we are learning things, as Matt talks about reimagining our business.
We're learning things now that I suspect will be durable, that we'll continue to use regardless of when we can have our field force, our commercial team, get back out there on a face-to-face basis. I'll turn it over to Matt and Iain regarding telemedicine and being able to write prescriptions.
Sure. I'll take a stab at the telemedicine portion of this. The physicians, when they do a consult via telemedicine, A, they would bill for that consult via whatever mechanism they typically would. They can make a prescription as they normally would for the patient, either by calling it into the pharmacy or using the EMR platform. That's typically how it works. I don't know, Iain, if you have any other color around it.
No, that's right, Matt. Just one comment on the discipline. I think dermatology, in general terms, are probably one of the more advanced medical specialties in relation to Telederm. That's primarily just a reflection of the fact that most dermatoses are mostly clinically identifiable. During this time, we're certainly hearing from a lot of our clinical centers and customers. They're adapting to this pretty well. Obviously, it's a moving target over time. As Matt said, primarily most of the prescriptions these days are through EMR. I'm sure anyone who goes to any clinic usually gets a prescription sent straight to a retail pharmacy these days, or if it's processed through a specialty pharmacy. We don't see any major problems in relation to a Telederm component to this.
Thanks, Iain. Thanks, Matt. Thanks, Shane.
Thank you. Our next question comes from the line of Oren Livnat with H.C. Wainwright. Please proceed with your question.
Thanks. I'd like to touch on a few things you've already addressed, maybe just a little more explicitly. We've seen, I think, about a 50% drop since the peak two weeks ago. That's undeniable. We're having to see an impact in the field. I'm just wondering, based on your leading indicators, do you expect that to sort of continue to melt downward until we get a bigger industry return to normal? Is there some sticky base there? Also just regarding the launch, I guess given the double whammy you sort of highlighted of the general disruption, but also the patients being at home, not in school, which I assume is a big demand driver in general, should we just assume that until there's like a definitive back to school season, so to speak, that we won't see any, I guess, ramp in prescriptions?
In the meantime, can you cut costs materially? Is there any reason that you would do that to extend your runway beyond second quarter next year? Thanks.
Sure. I'll talk to the second question. I think again, it's not necessarily clear that patients that have acne will just sit at home until it's time to go back to school. I was actually viewing it from a different lens is, patients that have acne, again, the preponderance of these patients are high schoolers, teenagers, college-based kids. We know the prevalence is call it 12, 13 through early 20s. These are high schoolers and college kids in their home. They still have acne, and they want to take care of it. What we're monitoring closely is this is a condition that physicians can diagnose and can treat through telemedicine. Obviously, this is visual. Same thing with rosacea. Perhaps there's opportunities for these patients that are home to get treated by physicians sooner than later, as opposed to wait to going back to school.
We're just monitoring that closely. It's not definitive, but there could be an opportunity there. That's how we look at it. Obviously, as Andrew, and he can offer some additional color, offered is we're very mindful of running our business as efficiently as possible, and doing what is necessary to manage our business and extend our cash runway as long as we can. That's where our focus is, but that's always is where our focus is, certainly more so than ever under today's current environment. I'll turn it back to Matt with any thoughts on the prescription trends and any leading indicators that we're seeing and what we anticipate in terms of flattening and then potentially rebounding.
Sure. Thanks, Dave, and thanks, Oren, for the question. One other point on the patients here is that we're talking about Generation Z, who are very comfortable with video chat, FaceTime, the types of things that lend itself nicely to telemedicine. As physicians become more comfortable with that platform, I think that we will see more of the patients engage. I don't think that they're going to wait until they go back to school necessarily to make that engagement for a number of reasons. One is, they probably expect to get back out and do their normal activities over the course of the summer.
I wouldn't anticipate that they're just going to sit at home and wait this out and then re-engage in July or August. When you ask about the durability and some of the things that we measure on a weekly and monthly basis, we look at the number of unique prescribers in the U.S., which has been steadily increasing on a weekly basis. The number of unique prescribers that are prescribing AMZEEQ have been growing steadily since launch, as you would expect. When we think about our targeting model, we were very efficient in how we defined our targets. We have 6,000 total targets. We examine the productivity of those targets, and when we look at the top 2,000 or so physicians, we look at the productivity of that group, and we see that they have moved along the line from trial to adoption nicely.
Those habits should be sticky over time. You don't become a semi-loyalist and then automatically stop that activity. We would expect that to continue. It's just a matter of the volume of patients right now, the physicians reimagining how they do business, and the patients coming back and engaging in those platforms. We think that we're going to be able to, as soon as some of the restrictions are lifted, that we'll get right back to business.
Thank you.
Thanks, Oren.
Our next question comes from the line of Patrick Dolezal with LifeSci Capital. Please proceed with your question.
Hi, thanks for taking the question. Just one on FCD105. Perhaps you could just kind of remind us of the rationale for this program in acne and help guide expectations for results. Then kind of in a similar vein, are there any impacts from COVID on this study?
Yeah, Iain, why don't you take that?
Hi, Patrick. Thanks for the question. FCD105, the rationale for that is, this is actually going to be the first combination minocycline topical product for the treatment of acne vulgaris. It's a 3% minocycline and a 0.3% adapalene topical form, very similar as consistency of form to AMZEEQ. As you know, that adapalene is probably the most highly written of the retinoids in dermatology, and that deals primarily with normalizing keratinization of acne. With respect to the impact of COVID-19 on the program itself, we no longer have any active patients in the study, the phase II study. We're in data cleaning mode just now, working very closely with our clinical centers to clean data as we lead up towards database lock. In relation to direct effect on patients attending visits, there is no effect on that.
Our plan is to communicate top-line results in Q2. That's still on track.
Great. Thanks.
Thank you. We have reached the end of our question-and-answer session. I'd like to turn the call back over to management for any closing remarks.
Thanks, operator, and thanks to everybody for taking time out of their schedules. We'll continue to keep you updated on the progress of our business, and most importantly, I wish everyone on this call to stay safe, be healthy, practice, obviously, appropriate social distancing. Like all of us, we look forward to getting back to normal courses of business as soon as possible. Stay well. Thanks, everyone.
Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.