Earnings Call: Q1 2020

May 11, 2020

Greetings. Welcome to the Menlo Therapeutics First Quarter 2020 Earnings Call. At this time, all participants are in a listen only phone. A question and answer session will follow the formal presentation. Please note this conference is being recorded. I will now turn the conference over to your host, Michael Wood at LifeSci Advisors. You may begin. Good morning, everyone, and thank you for joining us. Before we begin the formal remarks morning, I'd like to remind you that some of the information in the news release and on this conference call contain forward looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words that express and reflect optimism, satisfaction with current progress, prospects or 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 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 Menlo Therapeutics' filings with the SEC. These forward looking statements speak only as of the date of today's press release and conference call and the company no obligation to publicly update any forward looking statements or supply new information regarding their circumstances after the date of this call. So at this time, I'd like to turn the call over to Dave Domzalski, Chief Executive Officer of Menlo Therapeutics. Dave, please go ahead. Thank you, Michael, and good morning to everyone. Joining me on the call is Matt Wiley, our Chief Commercial Officer and Andrew Saic, our recently appointed Chief Financial Officer, who will take you through our financials. We're very pleased to have Andrew on the team. As this is his 1st quarterly call with us, I want to welcome him. So today, I will provide you with a brief update on both our commercial business as well as our pipeline, and then we'll turn the call over to Matt Andrew to provide more details. As you know, we launched our first product Amzeq in January. We have a PDUFA date coming up on June 2 for our second product FMX103 and assuming it's approved that will put us on track to launch our second product later this year. And our Phase 2 study in acne for FCD105 is slated for a readout in the coming weeks as well. To begin, in early March, we successfully closed the merger in which Foamix became a wholly owned subsidiary of Menlo Therapeutics. While we were disappointed with the outcome of the solopinib Phase 3 results that were subsequently announced, the transaction had been structured to provide a certain amount of protection of Foamix shareholders in the event of this outcome. The issuance of the contingent stock rights resulted in 82% ownership in the combined entity for Foamix shareholders, providing an adjusted ownership split for both legacy Menlo and Foamix holders. The transaction also resulted in a higher cash balance for the combined company. Additionally, as a result of the merger, we are now also a U. S. Domiciled publicly traded company. The launch of Amzik, our topical minocycline product into the U. S. Market as a treatment for moderate to severe acne marked the transition of Menlo from a development stage organization to a fully integrated commercial company. We're very pleased by the initial results of the launch of Amzik as well as the reception from patients and healthcare providers for our product, even though the momentum has understandably slowed as a result of COVID-nineteen. The strong prescription numbers we saw through the middle of March, however, give us confidence that we will be able to successfully market the product as the COVID-nineteen situation stabilizes in the U. S. Matt will give you an update on our commercial strategy. But suffice it to say, we are doing everything we can to educate our customers about the features and benefits of Amzik and increased trial and use of our product during the COVID-nineteen situation and as physician offices continue to open. FMX103, our 1.5 percent minocycline foam for the treatment of papulopustular rosacea, is currently being reviewed by the FDA, which has set a target PDUFA action date of June 2 this year. We have had fluid exchanges with the agency and we do not anticipate a change in the PDUFA date. If approved, our current expectation remains for a launch of FMX103 in the 4th quarter. The NDA includes what we believe to be a very strong clinical package. Both of our Phase III clinical trials that support the application met each of their co primary endpoints, demonstrating a statistically significant improvement in the reduction in inflammatory lesion counts and IgA treatment success. Behind 103, our most advanced pipeline product is FCD105 for the potential treatment of acne. FCD105 is our topical combination product. It utilizes our MST foam platform and comprises a 3% concentration of minocycline and a 0.3% concentration of adapalene. Adapalene is one of the most widely used topical retinoids to treat comedonal acne. FCD105 is currently in a Phase II trial, which completed enrollment late in 2019 and we remain on track for our anticipated data readout this quarter. We had our last patient out of the trial before the COVID-nineteen shutdown, so we do not expect any impact on the timeline of a readout top line results for FCD105. We believe that if approved, this combination product of minocycline and adapalene could provide a novel therapy to potentially address unmet needs of patients and healthcare providers. Finally, we were pleased to announce a few weeks ago our license agreement with Takeda Therapeutics to market Amzeq in China as well as our other topical minocycline products when approved. This license agreement provides a $10,000,000 upfront payment to Menlo plus mid single digit royalty payments on net sales of any of our licensed products to Cutia. We believe this transaction further validates our technology and the potential of Amzik. It also helps fortify our balance sheet with non dilutive funding. We will continue to seek additional partnership opportunities in non U. S. Territories for our topical minocycline product portfolio. With that, let me now turn the call over to Matt Wiley, who will provide an update on our commercial activities. Matt? Thanks, Dave. The early launch of Amzeq was very promising. The initial uptake and feedback from physicians exceeded our expectations and we remain optimistic about how Amzeq will be used to treat patients with moderate to severe acne. The launch has obviously been interrupted by COVID-nineteen and we saw a pullback in prescriptions as dermatology offices closed due to government restrictions. Our field force, however, has stayed engaged and continued to make sales calls virtually. While the volume of calls per day has been reduced in the virtual environment, in many cases, the duration of and quality of those calls has improved. We have found in the virtual environment, many of our physician customers now have more time to learn about ANSIQ and its differentiated attributes. We believe this should help increase the level of awareness of ANSIQ and ultimately trial for the brand. Despite the various government restrictions due to COVID-nineteen, the number of unique prescribers continues to grow week over week even during the period of shutdown. There have been over 3,200 unique prescribers of Amzik since launch with over 500 of them coming since the week ending March 13, which was the last week of non impacted sales. We've been able to reach over 90% of our targets since launch. We are also seeing productivity of our targets growing, averaging 8 prescriptions per target and over 10 from our most important customers, whom we refer to as our platinum targets. In February, we hosted a national satellite broadcast event with 2 of the most prominent key opinion leaders in the field of acne, Doctor. Jim DelRosso and Linda Steingold. This single event drew over 3 50 attendees at 38 live venues. We have also hosted over 30 live and virtual speaker programs that have reached a total of 2 50 attendees. The field force now redeploying where possible as government restrictions ease. In areas that are reopening now, there are some obvious changes to how we access physician offices and of course no one knows how quickly acne patients will return for diagnosis and treatment. This is happening now in some parts of the United States and we expect that states and counties will continue to ease restrictions over time, allowing more direct selling activity. As we look at the last few weeks of prescription trends, it appears that the initial decline has stabilized and we are now beginning to see volume for both NRxs and TRxs increase. We are encouraged by this as we navigate through the process of dermatologists reopening their we will continue to leverage all of the tools we have at our disposal in our efforts to increase demand for Amitiza. Our market access strategy continues to execute as planned and we continue to build towards broad access for AmSeq. We currently have approximately 50% of the market under contract. We were recently removed from the exclusion list of 1 of the largest TBMs and this will increase our access now to approximately 60% of commercial lives. Our access strategy is on track as we continue to work with the remaining key payers to ensure broad access to our product. We are also using this time to prepare for what we hope to be an approval and subsequent launch of FMX103. As you know, the PDUFA date for FMX103 is June 2. Assuming it is approved, our plan is to launch the product in the Q4 of this year. The patient and healthcare professional called on universe overlap between Amzeq and FMX103 is approximately 80%. We build our sales force in anticipation of launching both products and do not foresee a change in the structure due to the launch of FMX103. There will be some incremental launch costs, but given the similarity to the product, we will be able to leverage much of the commercial apparatus already built for MZ. Our strategy for market access of CapEx 103, leveraging existing contract carers knowledge of the AMP equation, its main profit zoom in price, which we hope will make the 4th quarter contract process efficient. I will now turn the call over to Andrew Saic to review the financials. Andrew? Yes. Thank you, Matt. Before I start with a review of the numbers, I want to remind everyone that this is the first time that we have reported as the new Menlo Therapeutics post the merger between Menlo and Foamix. The deal structure had Menlo as the legal acquirer, but Foamix was the accounting acquirer, so all historic numbers contained in our 10 Q are Foamix through the merger date and then combined financials thereafter. Revenues totaled $1,800,000 for the Q1 of 2020 compared with $300,000 in the comparable period for 2019. Revenues in Q1 2020 were generated from product sales of Amzeq, which we launched in January of 2020. For the Q1 of 2019, revenues consisted solely of royalties from our out licensed product Finacea Foam. The decrease in royalty revenues for the Q1 of 2020 as compared to royalty revenues for the Q1 of 2019 was due to a Finacea, which resulted in no royalties this quarter. In April 2020, however, LEO informed us that it had remedied their supply chain issues related to Finacea Foam and has resumed commercial activities for Finacea Foam in the U. S. Cost of goods sold were 300,000 for the Q1 of 2020. Our gross margin percentage of 85% was favorably impacted during the quarter by product sales with certain material produced prior to FDA approval and therefore expensed in prior periods. If inventory sold during the Q1 2020 was valued at cost, then our gross margin for the period would have been 79%. There was no cost of goods sold in the 3 months ended March 31, 2019 because our revenues in that period consisted solely of royalties. Our R and D expenses for the Q1 of 2020 were $16,000,000 compared to $10,800,000 for the Q1 of 2019. This increase was a result of higher employee related expenses, including $3,800,000 related to the severance expenses associated with legacy Menlo employees and as well as increased payroll and related expenses. In addition, clinical and manufacturing costs related to cerlopetin increased by $2,200,000 This was offset by a decrease of approximately $2,200,000 related to clinical manufacturing expenses for Amzeq and FMX103. Our selling, general and administrative expenses for the Q1 of 2020 were $25,400,000 compared with $5,300,000 for the comparable period in 2019. This was driven by employee related expenses, which increased by $10,500,000 consisting of $6,000,000 primarily due to the expansion of our employee base, including the hiring of the sales force as well as $4,300,000 related to the severance expenses to legacy Menlo employees. We incurred $3,600,000 in expenses relating to the merger, including SG and A expenses. Sales and marketing expenses increased by $1,800,000 related to the commercialization of Amzeek. Total one time expenses related to the merger and consisting primarily of severance and merger costs were $11,700,000 in the Q1. Our net loss for the Q1 of 2020 was $40,200,000 or $0.95 per share as compared to $15,200,000 or $0.47 share in the Q1 of 2019. The increase in net loss was primarily due to an increase in expenses incurred in connection with our commercial launch of Vanzeek together with the merger expenses and severance expenses for Menlo employees. Our weighted average share count reported in our Q1 financial results the timing of the merger and was approximately 40,000,000 shares. The actual share count at the end of Q1 as disclosed in our 10 Q was 61,500,000 shares. In April, we announced the outcome of the Phase 3 sirlapatib trials resulting in the conversion of the CSRs from the recent merger, which resulted in the issuance of 74,500,000 Menlo shares to Foamix shareholders of record as of the closing date. This means that our current share count post the issuance of shares related to the CSR conversion is approximately 136,000,000 shares. Our cash and cash equivalents and investments totaled $82,700,000 as of March 30, 20 20. This amount does not include the $10,000,000 upfront payment that we are due to receive in connection with the licensing deal with Cutia Therapeutics. Due to the COVID-nineteen impact and the resulting disruption of the Amzeq launch and with the recent failure of zolapodent, we have reevaluated our cost structure and implemented a cost savings initiative that we believe was necessary to extend our cost runway. I want to be clear, however, that these cost savings initiatives did not impact the size of our field force and we remain firmly committed to the launch of Amzik and FMX103 later in the year. Changes that were made include us moving from primarily an internal to quickly eliminate all legacy Menlo expenses from the organization post the sirlapoden results. Additionally, as we do not have any large scale trials ongoing or scheduled in the near term, we reduced our support for clinical activities, but are maintaining appropriate clinical capability for the future. You will appreciate that making projections of cash runway is highly uncertain in the current market given the impact and potential future impact of COVID-nineteen. We believe, however, that with the cost savings initiatives put in place and with the cash from the QTL license that we continue to have a cash runway into Q2 of next year without the need to take on additional debt or equity financing. We remain laser focused on the Amzik launch as well as the planned launch of FMX103 in the Q4 assuming approval, even as we aggressively manage our costs in the short term to extend our cash runway and look forward to the data read from FCD105 later this quarter. I will now turn the call back to Dave for closing remarks. Thanks, Andrew. Before I close, on behalf of my fellow colleagues and Board members, our heartfelt sympathy goes out to the families who have lost loved ones from the COVID-nineteen coronavirus, and our best wishes for a full and speedy recovery go to those who are currently fighting this illness. And certainly, our gratitude is sent to the countless healthcare workers and first responders who worked tirelessly on the front lines during these times. In closing, we continue to be resolute in our vision to create a scaled business in therapeutic dermatology through the development and launch of innovative products to address unmet needs of patients. We believe our initial strong launch efforts for AMZYK reflect the strength of the product and our commercial strategy, which we intend to replicate with the launch of FMX103 in rosacea when approved. As always, we plan to deliver on these goals while ultimately building long term value for our shareholders. That concludes our prepared remarks. We are ready now to open up the call to Q and A. So I'll turn it back to the Our first question is from Louise Chen from Cantor Fitzgerald. Please proceed with your question. So my first question is if you could provide more color on the stabilization and pickup of the AmzikRx's that you're seeing, how many weeks has this been? And in addition to the reopening of offices, what else is driving this? And then secondly, you talked about this cost saving initiative. I was wondering if you could give us more color on SG and A and R and D expenses in the second 79% what we should be using in the second quarter for sales? And the last question I have for you is on FMX103. You're ahead of a launch here. What is your go to market strategy? And where would this product fit into the treatment armamentarium for patients and physicians? Thank you. Thanks, Elyse. So, got a couple of questions there from you. So I'll turn the first one over to Matt to provide some more color on the stabilization and pickup for Amzeq. So, Matt, you want to take that? Sure. Thanks, David. Thanks, Louise, for the question. So what we've observed in probably the last 5 or 6 data points has been a bottom or kind of a formation of the bottom of our TRxs. And so the last data week we have, which is from a week ago, we see that there's been a slight uptick in TRxs. And I think that's due to the fact we had a handful of reps out making live calls about 2 weeks ago. We had a much larger number last week. And we anticipate actually that the majority of our sales representatives are going to have some live call activity this week. So I think that kind of speaks to the stabilization initially due to the virtual efforts that we undertook And then the additional growth that we've seen at least in the last one data point that we have has been due to some of that live activity and probably more physicians seeing patients in their practices. Yes. Thanks, Matt. So, Louisa, this is Andrew, and I'll take the next two questions. With regard to your cost savings, we're not going to provide specific guidance on this call. But I think relative to Q2, what you're going to see is a gradual decrease in our expenses relative to Q1. We had in Q1, as you know, we had a launch of Amzik and we had 2 clinical trials wrapping up, 1 on sirlapoden and then obviously 103. I think that you're going to see a gradual decrease of expenses that should kind of stabilize into a new norm later in the year, call it by Q4. With regard to gross margin, gross margin is going to be a little bit variable in the near term. I think Matt has talked previously about the use of the trial card that we're using in launch as we bring various medical groups up on formulary, that should stabilize. I think Dave has guided at a 90% gross margin going forward. Think that we'll slowly see us getting closer to that number as we move into the year. Yes. I'll offer some initial thoughts on the go to market strategy, and then turn it over to Matt. But just to echo his thoughts on the stabilization and pickup for Amzik. Again, I'm very pleased with the work that our team has done under very challenging environments. The work that the team has deployed, as Matt outlined, certainly seems to stress that we've stabilized the business. We've seen increases in time with physicians, quality of the calls with healthcare providers. I think all that bodes well for us as offices continue to open up. So again, very pleased with the work that the team has done under very challenging environments. For FMX103, as we've said, we've always viewed that the rosacea marketplace is an untapped marketplace for an opportunity for such as FMX103. Though it's a smaller marketplace than the acne arena, there is less competition and fewer products that are in development in the category. And when we take a look at the data from FMX103 in our clinical trials, not only did we have very strong efficacy results in our primary endpoints and reduction of lesion counts, but we also saw that had very meaningful impact on sector endpoints such as improvement in erythema, which Luis as you know there are products in the marketplace specifically indicated just for that. So we believe the product has lots of optionality, lots of potential in the category. We know from our discussions with healthcare providers that they are eager for a new product to address patients' unmet needs for this condition. I think we'll deploy a lot of the same focused efforts that we have done with Amzik. And so I'll turn it over to Matt to provide some additional color on our go to market strategy. Matt? Sure. Thanks, Dave. And so Luis, a couple of things to note here. One is that what we found in primary marker research is that better than 70% of the current rosacea patients are dissatisfied with their current treatment. In other words, they're likely or extremely likely to choose another therapy if something new were to come to market. And we've seen this also in retrospective claims analysis as well, where we see that roughly 70% would either discontinue or switch medications after their first diagnosis and therapeutic option. So this, coupled with what we see from physician behavior and how they've responded in market research, where there is a high preference share for the product profile of FMX103 really gives us an opportunity to position around this unmet need. So as we think of the go to market strategy, it's really predicated on unique positioning, not dissimilar to what we did with Amzik. Focusing more so on the unmet need and the clinical profile of FMX103. We have an ambition to accelerate our support and market access environment to ensure that we do have broad access for the product. And then there are a couple of unique discoveries that we've made in the market itself that we plan on using as part of our platform. I'm not going to disclose those here for competitive reasons, but we think they offer us significant opportunities, especially as a smaller company to compete with larger competitors. And we're going to use that leverage to our advantage. Okay, great. Thank you. And our next question is from David Amsellem from Piper Sandler. Please proceed with your question. Hi, everyone. This is Zach on David. Thank you for taking our question. This is a bit of a longer term question, but we were hoping to get a better sense of how the recent transition to telemedicine and other digital initiatives might permanently impact the promotional landscape and the broader derm space and what that might mean longer term for AmSeq in both acne and rosacea? And I do have a follow-up after that. Thank you. Go ahead, Matt. Sure. So we're seeing an increase in telemedicine, and we believe that acne and potentially rosacea are disease states that could be could benefit from the advance in telemedicine. We would expect that as physicians become more comfortable with the platform, we will see an increase in diagnosis. Of course, where we fit our efforts is predicated on patient concentration. So regardless of whether physicians are using a telemedicine platform or seeing patients live in their office, we're building our targeting approach around that patient volume. So we will continue to educate our physicians either in a virtual environment during the COVID-nineteen situation or live as we have historically with those physicians who are using either a live or telemedicine platform. That's pretty much it, yes. Okay, great. Thanks. And then one quick question regarding Amzik. Given the macroeconomic landscape and less disposable income in general, could you maybe speak quickly to the extent to which you will provide greater patient out of pocket support over the long term? Thank you. Sure. I mean, right now, we do have a copay relief program in place and we are capping a benefit of $40 but basically buying the prescription down to $35 as part of that co pay release. We also have a denial conversion program in place, but that typically goes away after you've secured broad access. That's always been our ambition to have broad enough access where the patient out of pocket exposure is relatively light. We always have flexibility in the future to make changes to those programs as we need to, but we feel like we've got a pretty good program right now in place to capture the majority of the patients and minimize the out of pocket burden. And our next question is from Stacy Ku from Cowen and Company. Please proceed with your question. Good morning. Thanks for taking my questions. And I wanted to extend my welcome to Andrew. First, just a question on the remaining managed care contracts for ENVEYQ. What's the expected cadence for additional contracting for the remainder of the year? And would you guys be willing to provide some guidance where you think the net pricing of Enveig might settle, either this year or long term? And I have a follow-up. Sure. I'll provide some initial thoughts on managed care, and I'll turn it back to Matt, and then Andrew can provide some thoughts on net pricing. But as alluded to, we're quite pleased with our contacts and our exchanges with the payers. So they go to the heart of our pricing and reimbursement strategy, which was to ensure patients and health care providers can get access to our product. That's obviously our most important objective, but to do so also in a responsible manner. We've taken the approach to partner with payers in the managed care arena since the very beginning, actually 18 months plus before we even launched the drug. So I believe it continues to pay off well for us. As you know, within the first two weeks of launch, we had under contract one of the largest PBMs, Express Scripts, in which Amzik was added to their national formulary in a Tier 2 preferred status. That was unexpected for us and we were pleased with that. As we alluded to on our call so far today, we've been removed from the exclusion list from another one of the largest PBMs. Our discussions in terms of contracts are fluid. We hope to have additional announcements in the coming weeks. Our objective has been to have the majority of the major payers under contract as we go into the Q3. We continue to be on target for that. And we've found also that additional payers that were not in our modeling, I mean, some of the regions say out in the West Coast have come to the table to negotiate contracts with us. I think again that goes to the benefits of the product itself. The view from the payers has consistently been that Amzik provides unique benefits to payers or to patients. So it's not viewed as a just a new dosage form. We continue to have our product go through full P and T review. And so I think the clinical merits of the product, coupled with our pricing strategy, continues to be supportive and we continue to see that. I'll turn it over to Matt to have any additional thoughts on the cadence of our efforts and Andrew can talk about net pricing. Sure. Thanks, Dave. Yes, and I think Dave has pretty much summed up there. What I'll say is that the conversations with the payers have been good. It's consistent with the market research that we've shared on previous calls and in previous venues. And we feel optimistic about being able to secure that broad access that has been our ambition since the start. Andrew? Yes. Thanks, Matt. Yes, and Stacy, thank you for the question and the welcome. Really happy to be here. With regard to net price on Amzeek, we've taken decision to wait a bit and see how the market develops. What I can tell you is we're really happy with our contracting. We think that that's going extremely well. And as Matt alluded to, we expect to have full coverage. We do not view this product as something that we need to give away, right? We think that there's a huge value add with the product. So we're taking a position where we're negotiating prices that we think are very fair to both us and to the Durham offices. And we'll be able to give you more guidance later in the year as things develop with the product. Yes. And I'll just add before Stacy, if they have any additional questions is, yes, as we are in discussions with the payers for Amzik, we've obviously let the payers know that we hope to have another product, FMX103, that will come back to them on those. It's the same product but a different concentration and a different indication. Since we're going through the efforts now of getting under contract for Amzik, we hope that this should facilitate a quicker process in having FMX103 assuming approved, added to the formularies for these various plants. That's great. You kind of answered my second question. I guess, just specifically, maybe your initial launch strategy for 103 in Q4, is it going to be a little bit more targeted just given the current situation Or any details would be appreciated. Yes, Matt. Yes. I mean, so the way that we think about targeting is, again, we look at the rosacea patient concentrations in physicians. We look at predilection concentrations in physicians. We look at predilection for brand versus generic. And we then rank those docs from top to bottom. So we can have a fairly targeted approach to this patient diagnosis in a way where we should see good productivity. And we're seeing that already with Amzic. Our targeting model is predicated on the same philosophy. And we're seeing that as we are working through our targeting list, our platinum targets, which are our highest decile positions, are much more productive than our mid tier, which are our gold targets. And then, of course, non targets, those that may be in an office where we have targets and they hear detail on AMZ. They then also prescribe obviously not with same productivity. So we're applying the same philosophy to FMX103 and we believe that that gives us a very focused and efficient Lee. And our next question is from Jason Gerberry from Bank of America. Please proceed with your question. Hi, good morning. This is Chi on for Jason. Thanks for taking my question. Just a couple on the FCD105. Given near term readout expectation, curious what's your expectation on the Phase 2 data? I guess, as it pertains to the safety and efficacy profile compared to MSeq. And the second question would be, you talked about how you're thinking about your cost structure reducing on the activities. Just curious, does that in any way impact the development on 105 if the basic data is supported? Thank you. Yes. Thanks, Gene. So FCD105, it's our first combination product. I think an important point to offer is, as you know, developing a topical minocycline was a challenging exercise. We're proud of being the 1st company ever to develop a topical 2nd generation tetracycline product, minocycline or doxycycline. No one's ever been able to do this before until we did it with Amzik. This is unstable molecule minocycline. So we were thrilled to be able to do that with minocycline. Equally as important is, it was also a quite a challenge to develop a combination product with minocycline and took quite a bit of time and it's a credit to the development team that we have in the organization. So it's really taking what we believe is a gold standard in the treatment of inflammatory acne, minocycline with a gold standard for treating comedonal acne, which is adapalene. So we have a stable product, cosmetically appealing, that's now underway in a Phase 2 study. It's a fairly substantial Phase 2 study. It's 400 patients split across 4 arms, 125 patients in the combination arm of 3% meniscalculin and 0.3 percent adapalene, 100 patients in each of the Monad arms and 75 patients in the vehicle. We'll obviously be looking at efficacy as well as safety. The bar obviously for this Phase 2 is versus vehicle, but we want to measure it against each of the individual constituents depending on what a Phase 2 program would have to look like. So in terms of comparing it to Amzik, I would not comment, Chi, on expectations till we actually see the data. Obviously, we have expectations, a meaningful expectation for this product. And I've said on record that if approved in the market, it could be the biggest product that we would have for this particular category. Dermatologists, they do use combination products a fair amount. And again, we believe it could address some end needs for patients and health care providers. But I'll hesitate on providing any comparators to Amzick, etcetera or any other product in the market until we get the results. I think from there, again, we anticipate having the readouts sometime this quarter. From there, we would obviously assuming success, we would schedule an end of Phase 2 meeting. That will take a little bit of time to get that scheduled. And then from there depending on the results, then we could look to move towards a Phase 3 program for FCD105. But I would not envision that study taking place certainly until sometime next year, probably the earlier part of next year. It kind of goes to the cost expenditures for the balance of 2020. Our focus is squarely on the launch of Amzik and what we hope to be an approval and launch for FMX103. There's not a lot of large clinical activities for organization over the course of the next couple of quarters. That's just a function of timing and a function of the normal progress of completing a trial, getting in front of the FDA and then beginning to establish what the next trial would look like. So there's no rush for us to do this. We want to make sure that we take appropriate timing, get in front of the FDA, review the data and then go from there. In the meantime, again, we're going to keep our costs squarely focused on the launch of Amzinc and FMX103 assuming approved, which has always been our focus for some time. I'll turn it to Andrew to have any additional thoughts or color. I think you covered it, Dave. I don't have anything to add on that. Thanks, Jay. Maybe just a quick follow-up on the OpEx for 1Q. How much of that total is one time non recurring costs post the merger? I think you'll see some color to that, but if you can provide that again, that would be great. Thanks. Yes. Sure, Chief. So there was 11,700,000 dollars in one time expenses. They broke down. There were $3,800,000 mainly severance, actually all severance in research and development and then $7,900,000 in SG and A and that broke down to $4,370,000,000 and $3,600,000 other. In addition, Chi, there were about $9,000,000 of expenses that were recorded on the Menlo side in the period between January 1 and the merger date. Those don't show up obviously on the financials, but they would show up in cash and then some of them would show up in accrued liabilities on the balance sheet, right, if the sums weren't paid. So total amount was $21,000,000 for the quarter, but only $11,700,000 ran through our P and L. Got it. Thank you. Sure. Our next question is from Patrick Dolezal from LifeSci Capital. Please proceed with your question. Hi, everyone. This is Valentino on Patrick. Thanks for taking our questions. Just a couple more on FCD105. Given a positive readout, what might the pivotal program look like FCD105 just in terms of patient numbers and the primary endpoints? And what do you anticipate the timeframe being for the duration as well as the associated costs? And maybe if you could give us more granularity on how you're thinking about the commercial prospects for FCD105, specifically when considering the competing products within the acne space? Thank you. Thanks, Valentina. I'll talk or share some thoughts on potential structure of the Phase 3 program and I'll turn it to Matt to talk more about the commercial opportunity around it. In short, the size of the Phase 3 study is going to depend on the results of the Phase 2. So it's tough for me to give you any concrete numbers around what that would look like. What we do envision though is that would be 2 Phase 3 studies, double blind vehicle controlled similar to what we've done in the past for our clinical programs with AMZYK as well as FMX103. Obviously, we have a lot of experience in knowing how to run trials in the derm category, especially for trials such as these. So we would it would be 2 Phase 3 studies, plus a long term safety extension, similar to what we have done also for FMX103 and AMZYK. We'd have the requisite human dermal safety studies, which we could run-in parallel. So normally, yes, under a normal environment, again, assuming we're not in a shutdown scenario as much of the country still is, we generally think somewhere in the range of 20 months or so all in from 1st patient enrolled until long term safety completed, somewhere in that range. We would anticipate that would go through then a normal 18 to 20 months or so, then it would go through a normal filing, and again, likely a 10 month review on this. So that gives you a sense of the duration of a clinical program. Again, we would not envision kicking off the Phase 3 program by the end of this year just based on timing. By the time again we get the readout of this Phase 2, get in front of the FDA for an end of Phase 2 meeting, start mapping out what a Phase 3 program would look like, etcetera. So I hope that helps. And then I'll turn it to Matt for some thoughts on the opportunity of the brand itself or the product itself. Matt? Sure. So it's still a bit early because we don't have Phase 2 readouts. But this is obviously a very big market and we believe that the combination of minocycline and adapalene creates a very novel product, one that would be desirous by the physicians. We will have established ourselves in the market by the time this would launch. We have a pretty good knowledge of where minocycline is being preferentially used in these patients as well as Adaptalyn for that matter. And so we think that it's a good market opportunity. It's still premature on kind of defining the go to market strategy, not knowing the Phase 2 data, but we're optimistic. Great. That's helpful. Thank Our next question is from Arun Livnat from H. C. Wainwright. Please proceed with your question. Hey, thanks for taking my questions. I have a couple. Just if you don't mind, I understand you're waiting until you have some more clarity on some of these contracts upcoming with managed care before you give us guidance on value per script. But for now, the math works out to like under $100 a script in IQVIA at least. And so can you help us understand what are the sort of bookends maybe around like best case, worst case for potential normalized growth to net? And maybe also some color on what percentage of your current volume that we're seeing come through IQVIA is coming from free drug? Thanks. I have a follow-up. Yes, Lauren. So as we've said in the past that the view from the payers is that their expectation is the net price plan to be somewhere between $200 $400 a unit. That's always been the assumption that we've operated within and that's our goal ultimately when all this shakes out to be somewhere in that range. At this stage that's where we'll stay in terms of providing any color around this. Obviously, as you can appreciate within the 1st couple of months of launch while we're engaged with payers to get under contract, our denial conversion program will take up a larger share of the volume than what ultimately will be the case once we're under contract. Our objective has always been to partner with payers as opposed to going around payers. We know a lot of other companies use these coupon programs in perpetuity. That is not our intent. We believe as Andrew outlined, we're not give the product away. We believe we have an excellent product. We believe we've got a very good pricing strategy and a good price point. Our objective is to get contracts wrapped up as we go into the Q3 with the major payers and once that's done we're going to shut off the denial conversion program. Understanding that there will be some patients that they may not get access to the product because it's not covered under formulary, but our intent is to have the vast majority of plans cover our product. So that will certainly improve the gross to net. That's also why we're not providing any guidance as you can appreciate right now because we're still in this transition period. But coming back to your fundamental question of where we anticipate the land, that $200 to $400 range has always been our focus and what we intend to lock in on. So I'll stop there and see if there's any additional questions. Yes. That's helpful. Thanks. And I guess you did mention some states are opening up. You've got some reps in those offices. So presumably, they're getting some feedback from those docs. And what are we seeing, if anything, yet I know it's early on, actual acne patients coming back into the offices? I think last quarter, I asked you if you thought the back to school season could be hit, if that would hit you guys. And you said not everybody is only getting their treatment because of back to school. So if that's not the case, hopefully, we're seeing some patients already coming into the office. Is that the case? Yes. So the data that we would use to help determine that, we're still not necessarily seeing that in the data. We saw the NRx for branded prescription. We saw the NRx volume decline by about 40% or so during the COVID-nineteen shutdown. We would anticipate that as physicians start to open their offices, they are going to start to see more acne patients. Now this is still in a magnitude of 50,000 plus NRxs per week. That's just down from the mid-seventy thousand back before the COVID-nineteen shutdown. So there are a lot of patients out there. The physicians who are opening up, I believe that they have a backlog of patients that they're working through. And so you'd expect that acne patients would be among those. Anecdotally, we are hearing that patients are coming back across the spectrum. One of the things that we saw during the last few weeks of data, which I think is interesting, is that if you look at share shifting between different drugs in the acne space, you see a share shift towards the isoprenoids, which means that the most severe patients were getting treated. That doesn't mean that there weren't other acne prescriptions being prescribed and other acne brands being prescribed. And we saw that. Clearly, we added 500 unique prescribers for AmZEEK over that period. So there is a Padreos physician to not only are prescribing branded products, but also taking up a trial for Amzik for the first time. So we think that the opening up of physician offices is a good thing because with that comes all the patients that may have been backlogged for a period of time. And we'll know more with real data probably in a couple of weeks. Okay. Yes. Orin, I'll offer some additional thoughts. Again, I think it goes to the efforts of our commercial team and our sales force. As we said, in this current environment, although the aggregate number of calls may be less than what a normal sales force would experience in a face to face environment, The feedback that we've gotten and what we've seen is that the duration and quality of the calls has increased. And so, we're seeing environments that in a normal or physician office that in a normal environment may be challenging to get a lot of face time with that particular practice, busy practice, navigating through a waiting room, navigating through the office protocol to get time, can be challenging. And we know that, for any commercial company in any therapeutic category, derm is not remiss from that. So what we are seeing is the team taking advantage of this particular time period and getting good quality time with ACPs. And so it's not unlike what we're doing right now. If you get that healthcare provider through a virtual call, whether it's FaceTime or the like or a virtual speaker event, you have a captive audience, you're engaged and that time may go from, in a normal face to face environment, 5 to 8 minutes to 10 minutes for a call to double or more than that. So that's enabled our team to have very good quality discussions and educational discussions about the features and the benefits of our product for their patients, with the aim that as the offices continue to open up, they obviously have an awareness of our product and an increased awareness. I think that's reflected in the fact that, as Matt outlined, we've seen over 500 new unique prescribers that have tried the drug, have prescribed Amzeek despite this current environment. So our hope is that serves us well as all of them continue to open up. I hope that provides some additional help with it. Yes, thanks. Appreciate it. Got it. And we have reached the end of the question and answer session. And I will now turn the call over to management for closing remarks. Okay. Thank you, operator. And again, thanks to everyone for taking time out of your busy schedules to listen to our call. We look forward to providing you with continued updates as our business progresses. And in the meantime, I hope we on behalf of the company, wish everyone the best. Stay well. Stay safe. We look forward to talking with you soon. Thank you. This concludes today's conference and you may disconnect your lines at this time. Thank you for your