NASDAQ:DERM Journey Medical Q4 2024 Earnings Report $7.47 -0.09 (-1.19%) Closing price 04/25/2025 04:00 PM EasternExtended Trading$7.44 -0.03 (-0.40%) As of 04/25/2025 06:51 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Journey Medical EPS ResultsActual EPS$0.08Consensus EPS -$0.22Beat/MissBeat by +$0.30One Year Ago EPSN/AJourney Medical Revenue ResultsActual Revenue$14.30 millionExpected Revenue$14.21 millionBeat/MissBeat by +$87.00 thousandYoY Revenue GrowthN/AJourney Medical Announcement DetailsQuarterQ4 2024Date3/26/2025TimeAfter Market ClosesConference Call DateWednesday, March 26, 2025Conference Call Time4:30PM ETUpcoming EarningsJourney Medical's Q1 2025 earnings is scheduled for Monday, May 12, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Journey Medical Q4 2024 Earnings Call TranscriptProvided by QuartrMarch 26, 2025 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to Journey Medical's twenty twenty four Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen only mode. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of this call will be available approximately one hour after the end of the call for approximately thirty days. Operator00:00:43I would now like to turn the call over to Jacqueline Jaffe, the company's Senior Director of Corporate Operations. Please go ahead. Speaker 100:00:54Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Merawi, Co Founder, President and Chief Executive Officer and Joseph Binesh, Chief Financial Officer. Joining for the Q and A portion of the call will be Randy Alush, General Counsel and Corporate Secretary Doctor. Srini Sidgheddy, Vice President of Research and Development and Louis Donati, Director of Market Access. During this call, management will be making forward looking statements, including statements that address, among other things, Journey Medical's expectations for future performance, operational results, financial condition and the receipt of regulatory approvals. Speaker 100:01:37Forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Journey Medical's most recently filed periodic reports on Form 10 ks and Form 10 q, the Form eight ks filed with the SEC today and the company's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call includes non GAAP financial measures that Journee Medical believes can be useful in evaluating its performance. You should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. For a reconciliation of this non GAAP financial measure to net loss, its most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release. Speaker 100:02:31The content of this call contains time sensitive information that is accurate only as of today, Wednesday, 03/26/2025. Except as required by law, Journey Medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Claude Murali, Co Founder, President and Chief Executive Officer of Journey Medical. Speaker 200:02:58Thank you, Jacqueline, and good afternoon to everyone on the call today. 2024 was a pivotal year for Journey Medical as we delivered on all of our guidance ranges for the year and position the company to launch MROCI, our best in class oral treatment for rosacea. We reported annual revenue of $56,000,000 in 2024. And the fourth quarter marked the sixth consecutive quarter that the company achieved positive non GAAP adjusted EBITDA. Additionally, we submitted our new drug application for IMROCI in early twenty twenty four and received an on time first cycle approval from the FDA in November. Speaker 200:03:47In 2024, we also paid out a total of $22,000,000 in FDA filing fees and milestone payments to Doctor. Reddy Labs. These one time payments completed our financial obligations associated with the IMROCI's regulatory fees and development milestones in The United States for the rosacea indication. As a result, this clears the way for AMROSI's commercial debut and our ability to increase our product revenues and operating cash flow as the product gains traction in the market. Despite these payments, our balance sheet remains strong ahead of the IMROCE launch with $20,300,000 in cash as of December 31. Speaker 200:04:41We believe that Journee is well positioned ahead of the IMROCE launch, given that our current commercial organization is already targeting the same dermatology prescribers that treat the vast majority of rosacea patients. This means that IMROCI sales have potential to generate significant operating leverage for the business. Given the market opportunity for IMROCI, which is entering $1,000,000,000 plus treatment category with superior Phase three clinical results against the current oral standard of care, we believe that the product can be transformational to our business. Other accomplishments in 2024 include presentations of IMROCI clinical data at key medical congresses, such as the American Academy of Dermatology annual conference in March, the Dermatologic Education Foundation, Nurse Practitioner and Physician Assistant Conference in July, and the Fall Clinical Dermatology Conference in October. And in November 2024, our licensed partner, Cutia Therapeutics, received regulatory approval to market Amzik in China, which triggered a $1,000,000 milestone payment to Journee. Speaker 200:06:12Continuing the business momentum from last year, 2025 is off to a strong start. Earlier this month, we hosted an exhibit booth at the twenty twenty five AAD Conference in Orlando, Florida. The AAD meeting attracts more than 20,000 attendees, including top dermatology KOLs and high prescribing physicians, nurse practitioners and physician assistants. Our exhibit booth at the conference was very productive in terms of foot traffic and the time that attendees spent in our exhibit to learn about IMROCI's recent FDA approval and our superior head to head Phase III results against Oration. Notably, dermatologists were interested in IMROCI's low dose modified release formulation comprised of ten milligram immediate release and thirty milligrams of extended release minocycline, as well as the product's favorable safety and tolerability profile. Speaker 200:07:26We also have served significant attendee interest in the before and after photos of patients in our Phase III clinical trials, which were a focal point in our exhibit. Many dermatologists already know Journee, our current products and the strong customer service that we provide, including our co pay assistance and access programs. We believe that the AAD meeting was highly successful and generated significant customer interest heading into the IMROCE launch. Our national sales meeting kicks off next week. And with our launch quantities in place, we recently began shipping MROCI inventory into the distribution channel and have already begun seeing prescriptions dispensed. Speaker 200:08:18As a result, we are well prepared to execute on a robust launch in early April. On our pre commercial update call in February, we noted approximately 12% commercial payer coverage for IMROCE at the time. Due to our initial market access efforts, which began immediately after IMROCE's FDA approval last November. As an update, we now have coverage of approximately 20% of the 188,000,000 commercial lives and 4% of the 58,000,000 Medicare lives, enabling those patients access to IMROCI through their health insurance plans. We expect the number of payers and covered lives to increase substantially throughout the remainder of this year and into 2026. Speaker 200:09:16So far, we believe that the early progress is promising and we expect to report on the ramp up in payer coverage throughout the year. Earlier this month, our Phase three results from Ambrosi were published in a peer reviewed article in the Journal of the American Medical Association or JAMA Dermatology, one of the most well recognized journals in medicine. Notably, this journal has among the highest impact factors in the dermatology field. The paper focused on the head to head clinical superiority of IMROCI on both of our co primary endpoints against Oresia and placebo with very high statistical significance. As well, the publication noted that IMROCI's Phase three results met all of the secondary endpoints, including a statistically significant benefit in reducing erythema or the retinas associated with rosacea compared to placebo. Speaker 200:10:23The publication also noted the favorable safety profile of IMROSI. We believe that the JAMA publication is a significant positive that coincides well with our launch and can create additional awareness of IMROCI's benefits as we roll the drug out into the market. In addition to the JAMA article, we anticipate two more publications on IMROCE this year, with one focusing on the microbiology study that we conducted, which demonstrates the drug's sub antimicrobial effects and the other on the quality of life improvement for patients taking IMROCI to treat their rosacea symptoms. As well, Journee is planning to attend, exhibit and present at additional dermatology focused medical congresses throughout 2025. With that, I will now turn the call over to our CFO, Joe Banesch, to review our financial results for 2024. Speaker 300:11:33Thank you, Claude, and hello, everyone. I'd like to start by saying that we are pleased to have met all of our financial guidance ranges for 2024. As a reminder, for the full year, we anticipated product sales in the range of $55,000,000 to $60,000,000 SG and A expense in the range of $39,000,000 to $42,000,000 and R and D expense in the range of $9,000,000 to $10,000,000 For this year, given the upcoming launch of IMROCI and the variability that goes along with any drug launch, we plan to offer 2025 financial guidance later in the year. After we assess initial and ROSI prescription demand, we have conducted additional payer contract negotiations. Moving to our financial results for 2024. Speaker 300:12:25Our total net product revenue in 2024 was $55,100,000 which compares to the $59,700,000 that we reported in 2023. The decrease was primarily due to overall higher rebate costs across our product portfolio and lower unit volumes mainly from our legacy products. Total revenues for 2024 were $56,100,000 This includes a $1,000,000 milestone payment that was triggered upon Cutia receiving market authorization for Amzik in China. Under the Cutia agreement, Journee is also entitled to royalties on sales of Amzik in the licensed territory. Full year 2023 total revenues of $79,000,000 includes a $19,000,000 upfront licensing payment and $500,000 in royalties that we received from our partner Maruho Limited. Speaker 200:13:27Ltd. Speaker 300:13:27Our cost of goods sold decreased by $2,000,000 or 9% to $20,900,000 for the full year 2024. The lower cost of goods was mainly due to decreased product royalties stemming from contractual royalty decreases in 2023 and the discontinuation of XEMINNO in 2023. Research and development expenses increased by $2,300,000 to $9,900,000 for the full year 2024. The increase was primarily driven by non recurring payments of $4,100,000 in the IMROCI NDA filing fee in January 2024 and the $3,000,000 contractual milestone payment to Doctor. Reddy's, which was triggered by the FDA's acceptance of our NDA application for IMROSI in March 2024. Speaker 300:14:20These increases were offset by lower clinical trial expenses as the IMROCE Phase III clinical program was concluded in 2023. Looking now to our SG and A expenses. SG and A decreased by $3,700,000 or 8% to $40,200,000 for the full year 2024. Year over year decrease was mainly due to the full realization of our expense optimization efforts that were completed in 2023. Continuing to our net loss for the periods. Speaker 300:14:56Net loss to common shareholders was $14,700,000 or $0.72 per share basic and diluted for the full year 2024. This compares to a net loss to common shareholders of $3,900,000 or $0.21 per share basic and diluted for the full year of 2023. The net loss in 2023 includes the license fee revenue and product related royalties of $19,500,000 that we received from Maruho. Turning now to our non GAAP results. Our non GAAP adjusted EBITDA for the full year 2024 was a positive $800,000 or $0.04 per share basic and $0.03 per share diluted. Speaker 300:15:40This compares to positive adjusted EBITDA of $15,600,000 or $0.85 per share basic, $0.75 per share diluted for the full year of 2023. This includes the licensee revenue and product related royalties of $19,500,000 that we received from Maruho. At 12/31/2024, we had $20,300,000 in cash and cash equivalents compared to the $27,400,000 at 12/31/2023. Thank you very much. I will now turn the call back over to Clyde. Speaker 200:16:18Thank you, Joe. We executed well in 2024, ending the year on a high note and setting up our business for a transformational year in 2025. IMROCI is now approved and ready for launch. And the entire company is energized as we prepare to go to market with a product that is clearly superior to the current standard of care and addresses an unmet need for improving the treatment of rosacea patients. As the first internally developed asset for the company, IMROCI fits directly into our current dermatology commercial model with no need to add to our sales force to promote the product. Speaker 200:17:02As such, we have the financial and organizational resources in place to execute on a strong launch. We believe that IMROCI will become a major growth driver for Journee Medical, given its potential to achieve peak annual sales of an estimated $200,000,000 in The United States and $100,000,000 internationally, providing significant operating leverage to our business. An exciting year lies ahead with several potential catalysts to create value, including the launch of IMROCI and subsequent ramp in prescriptions for the product two additional peer reviewed publications and medical conference presentations anticipated during the year and anticipated increase in covered lives gaining access to IMROCI during 2025. Our financial progress as we drive the business towards sustainable positive EBITDA and profitability and the potential for business development activity, which may include licensing the commercial rights to our products outside The U. S. Speaker 200:18:16To create additional shareholder value. We at Journe Medical are looking forward to a productive 2025, and we are laser focused on driving value for patients, our physician customers and our shareholders. Thank you. Operator, we are now ready to open the lines for Q and A. Operator00:18:41We will now begin the question and answer session. Our first question comes from Thomas Flaten with Lake Street Capital Markets. Please go ahead. Speaker 400:19:09Thank you. Hey, good afternoon. Thanks for taking the questions. Claude, just first on payer coverage. What do you think we should be expecting as you exit 2025? Speaker 400:19:18I know you said there'd be a nice ramp, but relative to the '24 ish percent that you have now, where do you think we should be ending the year? Speaker 200:19:27Yes. Hi, Thomas. Our goal obviously is to obtain as many covered lives as possible. The expectation to peak commercial coverage should take anywhere from twelve to say eighteen months. I do have our MarketAxess lead with us here, Louis Donati. Speaker 200:19:46I'm going to pass that to him and let him give you a little more detail. Speaker 500:19:52I appreciate the question by the way. MarketAxess team is working actively obviously on commercial coverage as well as the Medicare line of business. So out of the 188,000,000 lives commercially across The U. S, the anticipation that is April 1, July '1, October '1 and so forth, we will have that ramp up period with peak coverage twelve to eighteen months out. The anticipation again is based on a lot of the high demand through the field because the more demand, the better coverage we will get. Speaker 500:20:24And the head to head studies will back up that demand also because the payers are very happy with the head to head study. So to give you a specific target right now, let's just wait a few months until we get more intel from the demand from the field. And I'm actively working with the GPOs and PBMs to obviously let them know of the head to head study. So give us a few more months and we will report back. But again, peak coverage is twelve to eighteen months post launch. Speaker 400:20:53Great. I appreciate that. And then from your interactions with KOLs and other doctors at AAD, how important did they view the erythema data? And depending on that, what are you doing to get that data into the hands of physicians given that it didn't end up in the label? Speaker 200:21:12Yes. I guess a couple of things there. First of all, the AAD had significant interest from our providers and PAs as well. The erythema, interesting enough, was not the key subject at all. The head to head performance really is catching people and saying, okay, let me listen to more. Speaker 200:21:36Tell me about the safety. They did not hit the erythema whatsoever. Outside of that, we also have held already to date, Thomas, we've done three ad boards. We've done a scientific ad board already. And overwhelmingly, the response again the head to head is really what's capturing people's interest and why they want to prescribe MROCI moving forward. Speaker 200:22:03And that's really one of the reasons why we believe we anticipate this to becoming the new standard of care. In terms of erythema, to answer your question, we have our Head of Medical Affairs on as well and that's Doctor. Srinivas Siddhgidi and he can speak more about that. Srinivas Siddhgidi? Speaker 600:22:29Sure, Claude. Thank you so much. I hope I'm audible. Thomas, thanks for the question. First of all, we are very pleased with the JAMA publication and the data presented there. Speaker 600:22:43As Claude mentioned in his presentation, the JAMA publication covers the co primary endpoints as well as all the secondary endpoints. And erythema was one of the secondary endpoints, which showed success against placebo. And that data being in a journal like JAMA Derm is really very important and we are fortunate to get this out at the right time. With the high impact factor, the high credibility and the wide readership of JAMA Dermatology, there will be natural visibility of the IREDIMA data from the Phase III studies. And the medical affairs group is well trained to answer specific questions related to erythema from the dermatology prescribers about the Phase three results on erythema or any other clinical data related to those studies. Speaker 600:23:40As a result, we expect that the JAMA DERM publication will have a huge impact in disseminating the erythema data. Speaker 400:23:52Sorry, go ahead. Speaker 200:23:53Yes, Tom. The other part I would invite you if you haven't yet and as well as all the other listeners, the Ambrosi website really has phenomenal before and after photos. And I would invite you to take a look and see the baseline versus the finished results of the patients at week sixteen. It's pretty dramatic and there's really great indication of how powerful it is to your question specifically. Speaker 400:24:22Got it. Thanks for taking the questions. I appreciate it. Operator00:24:26And the next question comes from Scott Henry with AGP. Speaker 600:24:30Please go ahead. Speaker 700:24:34Thank you and good afternoon. I don't know if I missed it, but or if your plan is to do it later, but do you have any thoughts on 2025 guidance or a plan for initiating that? Speaker 200:24:52Yes. Give us a few more months. This is really mostly related to the 2024 and us hitting all of our guidance that we gave. So we're going to let the launch of Emarosy really begin here. We've got our national sales meeting set up next week and then we'll have the full force of the commercial team out there for physicians to hear their voice and learn about MROCI. Speaker 200:25:17So we're going to wait a little bit before we give guidance. So at this point, just please be patient with that. Speaker 700:25:25Okay. Fair enough. And then as far as the early days, because you have filled some prescriptions, Would you say that the reimbursement environment, has it been in line with expectations? Has it been better? Has it been worse? Speaker 700:25:45I know you have very few data points, but I'd like to ask the question just to see if there's anything there to focus on. Speaker 200:25:52Yes, definitely. The distribution into the pharmacy channel is there. So we're glad to say that we've got that checked off and ready to go for the full launch year in the next couple of weeks. In terms of coverage and reading into that, it's just too early to tell. We're definitely seeing the prescriptions coming in. Speaker 200:26:16We certainly have some coverage happening. I would tell you that around the 20% mark right now in terms of getting adoption on formularies is probably on target and what I would utilize at this point as of today. Okay. Speaker 700:26:37And should we expect reported revenues in Q1? I know you'll fill some scripts, but sometimes there's a lag there. Should we look for just modest small amounts in Q1? Speaker 200:26:50Yes, that's correct, Scott. Just I would tell you that Q2 will have a meaningful revenue starting to begin with IMROCE in Q2. I wouldn't expect much in Q1. Speaker 700:27:04Makes sense. And then for fourth quarter, if my math is correct, the revenue was down sequentially from Q3, somewhat notably. I know you talked about some of the reasons. My question is, when we think about the base business, is it more reflective of all the quarters in 2024? Or is there a step down in fourth quarter 'twenty four that we should think about continuing into 2025? Speaker 200:27:38Yes. I'll start out and then I'm going to hand this off to Joe. If you take a look at the last several years, I think the base business has been relatively steady. We've got some legacy brands that continue to erode. When we look at our base business, our core four, it's been pretty consistent. Speaker 200:28:00Joe, if you wanted to add to that, please. Speaker 300:28:03Yes. And I think when we look at the first quarter, the first quarter is always going to be a little bit lower, right, because of rate resets that go through our P and L. But I think you can look at the full year 2024 and that's more representative of the true business. Speaker 700:28:23Okay. So none of the products you would say have kind of reset at lower levels. I mean, mostly I'm thinking QBREXZA and Accutane are the main drivers there. Speaker 200:28:35Yes. QBREXZA continues to perform well for us. We continue to see script growth year over year. And it's holding very solid. It obviously has some new competition out there. Speaker 200:28:50But again, the prescriptions continue to show very good positive signs. Again, when you look year over year, we're growing that product. With Accutane, as we've stated in the past, there were a couple new entries towards the second and third quarter of twenty twenty four. We did see some slowdown with Accutane. We've stabilized that business relatively well and we believe we're going to have good performance with Accutane. Speaker 700:29:23Okay, great. And just one accounting question. I see the loss recovery of 4,553. Was that in fourth quarter? Is that related to the cyber attack? Speaker 700:29:38And also on the accounting side, the $15,000,000 approval milestone, how should we think about that being I thought we may see it expensed in the fourth quarter, but it doesn't look like it. How should we account for that going forward? Speaker 300:29:53Right. So to your first question, Scott, the $4,600,000 crypto, it was the recovery. We received the cash in December. So we're happy to put that through our P and L. And for the second question, the $15,000,000 we are able to capitalize that as an intangible asset and we will amortize that over the life of the patent, which is through 02/1939. Speaker 700:30:18Okay. And will that be amortized through the acquired intangible assets line, which is now broken it out or it will be lower down? Speaker 300:30:27No, it will be right in that line. Speaker 700:30:31Okay, great. Thank you for taking the questions. Speaker 300:30:34You're welcome. Operator00:30:35And the next question comes from Brandon Folkes with Rodman and Renshaw. Please go ahead. Speaker 800:30:43Hi, thanks for taking my questions and congratulations on all the progress. Maybe just two from me. Firstly, how do you think about pricing across the portfolio? Obviously, talking about more the legacy portfolio here in 2025? And then just kind of with the Amrosy launch, with the operating leverage you do have in your business, how do you think about capital allocation in 2025 and maybe beyond that as well? Speaker 800:31:13Thank you. Speaker 200:31:16Sure. Joe, would you like to take that? Speaker 300:31:20Sure. Calvin, as far as capital allocation, we're good with cash. We're very comfortable with our cash at this point. And can you talk can you speak to the other part of the question, please? Speaker 800:31:41Pricing across the base business or legacy portfolio in 2025, just sort of what are you seeing? Obviously, there's competitor interaction. So maybe just whether you want to go product by product or just sort of holistically across the portfolio, how do we think about kind of net pricing in 2025? Speaker 300:31:59So in 2025 go ahead, Claude. Speaker 200:32:03Yes. I mean, just generally, Brandon, with our legacy brands, when we look at ExoDerm and TargaDox, I think our pricing is going to be holding steady. We don't see much of a difference between one year to the next. The fact is those brands do have their competitive generics out there, especially with Targetox. So there's some erosion in the volume of the scripts more so than it is a pricing game with that. Speaker 200:32:41The one benefit is too with ExelDerm is we no longer have the obligation of paying royalties, so our margins for that product have actually gotten better. And then in terms of our remainder, our Core four as I've been calling it in 2024, we believe that net pricing should remain the same as you've seen. Operator00:33:12And the next question comes from Jason Wits with Roth Capital. Please go ahead. Speaker 900:33:18Hi. Thanks for taking the questions. In terms of sort of the milestones for the MROC launch that you guys are looking for internally, at least the things that I guess the bottlenecks, I mean reimbursement and getting into formulary, I would think would be sort of the main things to track, obviously, at least from our checks and physicians, there seems to be a lot of interest in the drug from the physician side. But I assume just that logistics of those other two items are kind of what's going to determine the outlook for 2025. Is that the right way to think about it? Speaker 200:33:53Yes. I think you're tracking correctly. I think there were two areas that we need to focus in on. One was supply and we're glad to say that we've got ample supply and more supply on the way. So we feel real good with that. Speaker 200:34:08The distribution part has been taken care of and the backup supplies again are we're in a good position there. So I think you can put that one on the side. Secondly, in terms of getting more formulary coverage, we feel really good. And the progress that we've done already, I think, shows a good indicator in where things are going. We've had great conversations with all the major plans. Speaker 200:34:37And I keep saying it, but it's so meaningful. These small molecules, there's not too many head to head comparisons. And when you're able to demonstrate statistical significance with a highly efficacious product, the plans are certainly interested and we feel very good in terms of being able to get on these formularies. The one area is like Louis just said earlier, it takes anywhere between twelve to eighteen months and we will see good progress on a quarterly basis and better coverage as we go. So it's have a little patience in this game, but on all accounts it looks very promising from that point as well. Speaker 900:35:28Okay. That's helpful. Thank you. And I guess you put out $100,000,000 international opportunity for Amorosi. Is that something that you're going to look to outlicense at some point? Speaker 900:35:40I assume that's kind of the goal here or how should we think about that? Speaker 200:35:45Yes. In terms of finding the right partner to out license to is exactly what we're looking at. We certainly want to focus our efforts here in The United States. We've got a real good handle on that and that's where our focus is going to be. But our business development strategy is to out license this. Speaker 200:36:08And I think as we continue to see early success onward in 2025, I think it makes it even that much more tempting for partners outside to look at Neurosy as a very viable product on an international basis. Speaker 900:36:28Got it. Thanks. I'll jump back in queue. Operator00:36:33And the next question comes from Talpit Patel with B. Riley Securities. Please go ahead. Speaker 1000:36:39Yes. Hey, good afternoon and thanks for taking the questions. Maybe a few on the market access and launch related questions. You mentioned that the peak coverage for MROCI, you would expect twelve to eighteen months from the day of the launch. I guess what exactly is the peak coverage percentage? Speaker 1000:37:03That's the question number one. And then the second question is in terms of the covered lives, you gave a new updated 204% number for the different groups. What percentage of those are unrestricted versus single step edits? Speaker 200:37:27Thanks, Kelpit. Louis, would you like to take that one, please? Speaker 500:37:33Sure. Hi, Kelpit. It's Lou, by the way. Thanks for the call and thanks for the question. So peak coverage, again, trying to get ahead of it is maybe doing a disservice to what we're trying to do early on because I don't want to give you a number right now, twelve to eighteen months down the road. Speaker 500:37:50All I can say is we've prepped the market early fall through today and right now about 20% commercial coverage is where the forecast should be, actually ahead of forecast in my opinion. I expect them ROESY because again we keep on talking about head to head studies and demand. I really believe this will be a really good product to the market rosacea and we will get the coverage that we anticipated. But just give us a few months to get out there with the field force and we can report back number one. Number two, the 20% commercial coverage and that includes federal employees and health exchange out of the one hundred and eighty eight million lives. Speaker 500:38:30There's a mixed bag of unrestricted access and restricted So the good news is the payer response has been very positive and there are some payers that are actually adopting the Merosi currently in an unrestricted position with no utilization management and that is prior authorization and no step. So the response has been very well received. Again, give us some time as the market access team they get out there once we get the demand from the field. That is definitely going to help our discussions long term. But just give us a few more months and we will report back, okay? Speaker 1000:39:04Okay, got it. And a couple of follow ups here. Is the step edits that's being mandated by some of these payers, should we assume that that's a generic ratio or does it also include off label antibodies? Speaker 500:39:21Primarily, the payer response has been if to get to them, Rosy, if there's going to be a step edit, it's going to be through generic oral agent. It could be minocycline and or doxycycline. The drug policies will vary, but generic oral agents would be the step. Speaker 1000:39:42Got it. Okay. And then last question for me. After you guys announced your pricing and launched the drug here, has there been any pricing moved by Galderma for their branding ratio? Speaker 200:39:58Yes. Actually, we have not seen any market movement in terms of pricing, Calcutt, since we've launched. Okay. Since we've announced. Speaker 1000:40:06Okay. Got it. Thank you very much for taking the questions. Operator00:40:13This concludes our question and answer session. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallJourney Medical Q4 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Annual report(10-K) Journey Medical Earnings HeadlinesIs Journey Medical Corporation (DERM) a Cheap Hot Stock to Buy Right Now?April 18, 2025 | msn.comJourney Medical promotes Ramsey Alloush to COOApril 2, 2025 | markets.businessinsider.comFrom Social Security to Social Prosperity?In less than a decade, Social Security could be out of money. But a surprising plan from Trump’s inner circle may not just save the system — it could unlock a major opportunity for savvy investors. Financial insider Jim Rickards calls it “Social Prosperity,” and says those who act now could see the biggest gains.April 28, 2025 | Paradigm Press (Ad)Journey Medical Corporation Appoints Ramsey Alloush as Chief Operating OfficerApril 1, 2025 | globenewswire.comB.Riley Financial Sticks to Their Buy Rating for Journey Medical Corp (DERM)March 29, 2025 | markets.businessinsider.comJourney Medical Corporation (NASDAQ:DERM) Q4 2024 Earnings Call TranscriptMarch 28, 2025 | msn.comSee More Journey Medical Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Journey Medical? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Journey Medical and other key companies, straight to your email. Email Address About Journey MedicalJourney Medical (NASDAQ:DERM) focuses on the development and commercialization of pharmaceutical products for the treatment of dermatological conditions in the United States. The company's marketed products include Qbrexza, a medicated cloth towelette for the treatment of primary axillary hyperhidrosis; Accutane, an oral isotretinoin drug to treat severe recalcitrant nodular acne; and Amzeeq, a topical formulation of minocycline for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. It also offers Zilxi, a topical minocycline treatment for inflammatory lesions of rosacea; Exelderm cream and solution an antifungal intended for topical use; Targadox, an oral doxycycline drug for adjunctive therapy for severe acne; and Luxamend, a water-based emulsion formulated to provide a moist healing environment for superficial wounds; minor cuts or scrapes; dermal ulcers; donor sites; first- and second-degree burns, including sunburns; and radiation dermatitis. In addition, the company sells sulconazole nitrate cream and solution indicated for the treatment of tinea cruris, tinea corporis, and tinea versicolor; and doxycycline hyclate tablets, as an adjunctive therapy for severe acne. The company was formerly known as Coronado Dermatology, Inc. and changed its name to Journey Medical Corporation. Journey Medical Corporation was incorporated in 2014 and is headquartered in Scottsdale, Arizona. 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There are 11 speakers on the call. Operator00:00:00Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to Journey Medical's twenty twenty four Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen only mode. Participants of this call are advised that the audio of this conference call is being broadcast live over the Internet and is also being recorded for playback purposes. A webcast replay of this call will be available approximately one hour after the end of the call for approximately thirty days. Operator00:00:43I would now like to turn the call over to Jacqueline Jaffe, the company's Senior Director of Corporate Operations. Please go ahead. Speaker 100:00:54Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Merawi, Co Founder, President and Chief Executive Officer and Joseph Binesh, Chief Financial Officer. Joining for the Q and A portion of the call will be Randy Alush, General Counsel and Corporate Secretary Doctor. Srini Sidgheddy, Vice President of Research and Development and Louis Donati, Director of Market Access. During this call, management will be making forward looking statements, including statements that address, among other things, Journey Medical's expectations for future performance, operational results, financial condition and the receipt of regulatory approvals. Speaker 100:01:37Forward looking statements involve risks and other factors that may cause actual results to differ materially from those statements. For more information about these risks, please refer to the risk factors described in Journey Medical's most recently filed periodic reports on Form 10 ks and Form 10 q, the Form eight ks filed with the SEC today and the company's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call includes non GAAP financial measures that Journee Medical believes can be useful in evaluating its performance. You should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. For a reconciliation of this non GAAP financial measure to net loss, its most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release. Speaker 100:02:31The content of this call contains time sensitive information that is accurate only as of today, Wednesday, 03/26/2025. Except as required by law, Journey Medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Claude Murali, Co Founder, President and Chief Executive Officer of Journey Medical. Speaker 200:02:58Thank you, Jacqueline, and good afternoon to everyone on the call today. 2024 was a pivotal year for Journey Medical as we delivered on all of our guidance ranges for the year and position the company to launch MROCI, our best in class oral treatment for rosacea. We reported annual revenue of $56,000,000 in 2024. And the fourth quarter marked the sixth consecutive quarter that the company achieved positive non GAAP adjusted EBITDA. Additionally, we submitted our new drug application for IMROCI in early twenty twenty four and received an on time first cycle approval from the FDA in November. Speaker 200:03:47In 2024, we also paid out a total of $22,000,000 in FDA filing fees and milestone payments to Doctor. Reddy Labs. These one time payments completed our financial obligations associated with the IMROCI's regulatory fees and development milestones in The United States for the rosacea indication. As a result, this clears the way for AMROSI's commercial debut and our ability to increase our product revenues and operating cash flow as the product gains traction in the market. Despite these payments, our balance sheet remains strong ahead of the IMROCE launch with $20,300,000 in cash as of December 31. Speaker 200:04:41We believe that Journee is well positioned ahead of the IMROCE launch, given that our current commercial organization is already targeting the same dermatology prescribers that treat the vast majority of rosacea patients. This means that IMROCI sales have potential to generate significant operating leverage for the business. Given the market opportunity for IMROCI, which is entering $1,000,000,000 plus treatment category with superior Phase three clinical results against the current oral standard of care, we believe that the product can be transformational to our business. Other accomplishments in 2024 include presentations of IMROCI clinical data at key medical congresses, such as the American Academy of Dermatology annual conference in March, the Dermatologic Education Foundation, Nurse Practitioner and Physician Assistant Conference in July, and the Fall Clinical Dermatology Conference in October. And in November 2024, our licensed partner, Cutia Therapeutics, received regulatory approval to market Amzik in China, which triggered a $1,000,000 milestone payment to Journee. Speaker 200:06:12Continuing the business momentum from last year, 2025 is off to a strong start. Earlier this month, we hosted an exhibit booth at the twenty twenty five AAD Conference in Orlando, Florida. The AAD meeting attracts more than 20,000 attendees, including top dermatology KOLs and high prescribing physicians, nurse practitioners and physician assistants. Our exhibit booth at the conference was very productive in terms of foot traffic and the time that attendees spent in our exhibit to learn about IMROCI's recent FDA approval and our superior head to head Phase III results against Oration. Notably, dermatologists were interested in IMROCI's low dose modified release formulation comprised of ten milligram immediate release and thirty milligrams of extended release minocycline, as well as the product's favorable safety and tolerability profile. Speaker 200:07:26We also have served significant attendee interest in the before and after photos of patients in our Phase III clinical trials, which were a focal point in our exhibit. Many dermatologists already know Journee, our current products and the strong customer service that we provide, including our co pay assistance and access programs. We believe that the AAD meeting was highly successful and generated significant customer interest heading into the IMROCE launch. Our national sales meeting kicks off next week. And with our launch quantities in place, we recently began shipping MROCI inventory into the distribution channel and have already begun seeing prescriptions dispensed. Speaker 200:08:18As a result, we are well prepared to execute on a robust launch in early April. On our pre commercial update call in February, we noted approximately 12% commercial payer coverage for IMROCE at the time. Due to our initial market access efforts, which began immediately after IMROCE's FDA approval last November. As an update, we now have coverage of approximately 20% of the 188,000,000 commercial lives and 4% of the 58,000,000 Medicare lives, enabling those patients access to IMROCI through their health insurance plans. We expect the number of payers and covered lives to increase substantially throughout the remainder of this year and into 2026. Speaker 200:09:16So far, we believe that the early progress is promising and we expect to report on the ramp up in payer coverage throughout the year. Earlier this month, our Phase three results from Ambrosi were published in a peer reviewed article in the Journal of the American Medical Association or JAMA Dermatology, one of the most well recognized journals in medicine. Notably, this journal has among the highest impact factors in the dermatology field. The paper focused on the head to head clinical superiority of IMROCI on both of our co primary endpoints against Oresia and placebo with very high statistical significance. As well, the publication noted that IMROCI's Phase three results met all of the secondary endpoints, including a statistically significant benefit in reducing erythema or the retinas associated with rosacea compared to placebo. Speaker 200:10:23The publication also noted the favorable safety profile of IMROSI. We believe that the JAMA publication is a significant positive that coincides well with our launch and can create additional awareness of IMROCI's benefits as we roll the drug out into the market. In addition to the JAMA article, we anticipate two more publications on IMROCE this year, with one focusing on the microbiology study that we conducted, which demonstrates the drug's sub antimicrobial effects and the other on the quality of life improvement for patients taking IMROCI to treat their rosacea symptoms. As well, Journee is planning to attend, exhibit and present at additional dermatology focused medical congresses throughout 2025. With that, I will now turn the call over to our CFO, Joe Banesch, to review our financial results for 2024. Speaker 300:11:33Thank you, Claude, and hello, everyone. I'd like to start by saying that we are pleased to have met all of our financial guidance ranges for 2024. As a reminder, for the full year, we anticipated product sales in the range of $55,000,000 to $60,000,000 SG and A expense in the range of $39,000,000 to $42,000,000 and R and D expense in the range of $9,000,000 to $10,000,000 For this year, given the upcoming launch of IMROCI and the variability that goes along with any drug launch, we plan to offer 2025 financial guidance later in the year. After we assess initial and ROSI prescription demand, we have conducted additional payer contract negotiations. Moving to our financial results for 2024. Speaker 300:12:25Our total net product revenue in 2024 was $55,100,000 which compares to the $59,700,000 that we reported in 2023. The decrease was primarily due to overall higher rebate costs across our product portfolio and lower unit volumes mainly from our legacy products. Total revenues for 2024 were $56,100,000 This includes a $1,000,000 milestone payment that was triggered upon Cutia receiving market authorization for Amzik in China. Under the Cutia agreement, Journee is also entitled to royalties on sales of Amzik in the licensed territory. Full year 2023 total revenues of $79,000,000 includes a $19,000,000 upfront licensing payment and $500,000 in royalties that we received from our partner Maruho Limited. Speaker 200:13:27Ltd. Speaker 300:13:27Our cost of goods sold decreased by $2,000,000 or 9% to $20,900,000 for the full year 2024. The lower cost of goods was mainly due to decreased product royalties stemming from contractual royalty decreases in 2023 and the discontinuation of XEMINNO in 2023. Research and development expenses increased by $2,300,000 to $9,900,000 for the full year 2024. The increase was primarily driven by non recurring payments of $4,100,000 in the IMROCI NDA filing fee in January 2024 and the $3,000,000 contractual milestone payment to Doctor. Reddy's, which was triggered by the FDA's acceptance of our NDA application for IMROSI in March 2024. Speaker 300:14:20These increases were offset by lower clinical trial expenses as the IMROCE Phase III clinical program was concluded in 2023. Looking now to our SG and A expenses. SG and A decreased by $3,700,000 or 8% to $40,200,000 for the full year 2024. Year over year decrease was mainly due to the full realization of our expense optimization efforts that were completed in 2023. Continuing to our net loss for the periods. Speaker 300:14:56Net loss to common shareholders was $14,700,000 or $0.72 per share basic and diluted for the full year 2024. This compares to a net loss to common shareholders of $3,900,000 or $0.21 per share basic and diluted for the full year of 2023. The net loss in 2023 includes the license fee revenue and product related royalties of $19,500,000 that we received from Maruho. Turning now to our non GAAP results. Our non GAAP adjusted EBITDA for the full year 2024 was a positive $800,000 or $0.04 per share basic and $0.03 per share diluted. Speaker 300:15:40This compares to positive adjusted EBITDA of $15,600,000 or $0.85 per share basic, $0.75 per share diluted for the full year of 2023. This includes the licensee revenue and product related royalties of $19,500,000 that we received from Maruho. At 12/31/2024, we had $20,300,000 in cash and cash equivalents compared to the $27,400,000 at 12/31/2023. Thank you very much. I will now turn the call back over to Clyde. Speaker 200:16:18Thank you, Joe. We executed well in 2024, ending the year on a high note and setting up our business for a transformational year in 2025. IMROCI is now approved and ready for launch. And the entire company is energized as we prepare to go to market with a product that is clearly superior to the current standard of care and addresses an unmet need for improving the treatment of rosacea patients. As the first internally developed asset for the company, IMROCI fits directly into our current dermatology commercial model with no need to add to our sales force to promote the product. Speaker 200:17:02As such, we have the financial and organizational resources in place to execute on a strong launch. We believe that IMROCI will become a major growth driver for Journee Medical, given its potential to achieve peak annual sales of an estimated $200,000,000 in The United States and $100,000,000 internationally, providing significant operating leverage to our business. An exciting year lies ahead with several potential catalysts to create value, including the launch of IMROCI and subsequent ramp in prescriptions for the product two additional peer reviewed publications and medical conference presentations anticipated during the year and anticipated increase in covered lives gaining access to IMROCI during 2025. Our financial progress as we drive the business towards sustainable positive EBITDA and profitability and the potential for business development activity, which may include licensing the commercial rights to our products outside The U. S. Speaker 200:18:16To create additional shareholder value. We at Journe Medical are looking forward to a productive 2025, and we are laser focused on driving value for patients, our physician customers and our shareholders. Thank you. Operator, we are now ready to open the lines for Q and A. Operator00:18:41We will now begin the question and answer session. Our first question comes from Thomas Flaten with Lake Street Capital Markets. Please go ahead. Speaker 400:19:09Thank you. Hey, good afternoon. Thanks for taking the questions. Claude, just first on payer coverage. What do you think we should be expecting as you exit 2025? Speaker 400:19:18I know you said there'd be a nice ramp, but relative to the '24 ish percent that you have now, where do you think we should be ending the year? Speaker 200:19:27Yes. Hi, Thomas. Our goal obviously is to obtain as many covered lives as possible. The expectation to peak commercial coverage should take anywhere from twelve to say eighteen months. I do have our MarketAxess lead with us here, Louis Donati. Speaker 200:19:46I'm going to pass that to him and let him give you a little more detail. Speaker 500:19:52I appreciate the question by the way. MarketAxess team is working actively obviously on commercial coverage as well as the Medicare line of business. So out of the 188,000,000 lives commercially across The U. S, the anticipation that is April 1, July '1, October '1 and so forth, we will have that ramp up period with peak coverage twelve to eighteen months out. The anticipation again is based on a lot of the high demand through the field because the more demand, the better coverage we will get. Speaker 500:20:24And the head to head studies will back up that demand also because the payers are very happy with the head to head study. So to give you a specific target right now, let's just wait a few months until we get more intel from the demand from the field. And I'm actively working with the GPOs and PBMs to obviously let them know of the head to head study. So give us a few more months and we will report back. But again, peak coverage is twelve to eighteen months post launch. Speaker 400:20:53Great. I appreciate that. And then from your interactions with KOLs and other doctors at AAD, how important did they view the erythema data? And depending on that, what are you doing to get that data into the hands of physicians given that it didn't end up in the label? Speaker 200:21:12Yes. I guess a couple of things there. First of all, the AAD had significant interest from our providers and PAs as well. The erythema, interesting enough, was not the key subject at all. The head to head performance really is catching people and saying, okay, let me listen to more. Speaker 200:21:36Tell me about the safety. They did not hit the erythema whatsoever. Outside of that, we also have held already to date, Thomas, we've done three ad boards. We've done a scientific ad board already. And overwhelmingly, the response again the head to head is really what's capturing people's interest and why they want to prescribe MROCI moving forward. Speaker 200:22:03And that's really one of the reasons why we believe we anticipate this to becoming the new standard of care. In terms of erythema, to answer your question, we have our Head of Medical Affairs on as well and that's Doctor. Srinivas Siddhgidi and he can speak more about that. Srinivas Siddhgidi? Speaker 600:22:29Sure, Claude. Thank you so much. I hope I'm audible. Thomas, thanks for the question. First of all, we are very pleased with the JAMA publication and the data presented there. Speaker 600:22:43As Claude mentioned in his presentation, the JAMA publication covers the co primary endpoints as well as all the secondary endpoints. And erythema was one of the secondary endpoints, which showed success against placebo. And that data being in a journal like JAMA Derm is really very important and we are fortunate to get this out at the right time. With the high impact factor, the high credibility and the wide readership of JAMA Dermatology, there will be natural visibility of the IREDIMA data from the Phase III studies. And the medical affairs group is well trained to answer specific questions related to erythema from the dermatology prescribers about the Phase three results on erythema or any other clinical data related to those studies. Speaker 600:23:40As a result, we expect that the JAMA DERM publication will have a huge impact in disseminating the erythema data. Speaker 400:23:52Sorry, go ahead. Speaker 200:23:53Yes, Tom. The other part I would invite you if you haven't yet and as well as all the other listeners, the Ambrosi website really has phenomenal before and after photos. And I would invite you to take a look and see the baseline versus the finished results of the patients at week sixteen. It's pretty dramatic and there's really great indication of how powerful it is to your question specifically. Speaker 400:24:22Got it. Thanks for taking the questions. I appreciate it. Operator00:24:26And the next question comes from Scott Henry with AGP. Speaker 600:24:30Please go ahead. Speaker 700:24:34Thank you and good afternoon. I don't know if I missed it, but or if your plan is to do it later, but do you have any thoughts on 2025 guidance or a plan for initiating that? Speaker 200:24:52Yes. Give us a few more months. This is really mostly related to the 2024 and us hitting all of our guidance that we gave. So we're going to let the launch of Emarosy really begin here. We've got our national sales meeting set up next week and then we'll have the full force of the commercial team out there for physicians to hear their voice and learn about MROCI. Speaker 200:25:17So we're going to wait a little bit before we give guidance. So at this point, just please be patient with that. Speaker 700:25:25Okay. Fair enough. And then as far as the early days, because you have filled some prescriptions, Would you say that the reimbursement environment, has it been in line with expectations? Has it been better? Has it been worse? Speaker 700:25:45I know you have very few data points, but I'd like to ask the question just to see if there's anything there to focus on. Speaker 200:25:52Yes, definitely. The distribution into the pharmacy channel is there. So we're glad to say that we've got that checked off and ready to go for the full launch year in the next couple of weeks. In terms of coverage and reading into that, it's just too early to tell. We're definitely seeing the prescriptions coming in. Speaker 200:26:16We certainly have some coverage happening. I would tell you that around the 20% mark right now in terms of getting adoption on formularies is probably on target and what I would utilize at this point as of today. Okay. Speaker 700:26:37And should we expect reported revenues in Q1? I know you'll fill some scripts, but sometimes there's a lag there. Should we look for just modest small amounts in Q1? Speaker 200:26:50Yes, that's correct, Scott. Just I would tell you that Q2 will have a meaningful revenue starting to begin with IMROCE in Q2. I wouldn't expect much in Q1. Speaker 700:27:04Makes sense. And then for fourth quarter, if my math is correct, the revenue was down sequentially from Q3, somewhat notably. I know you talked about some of the reasons. My question is, when we think about the base business, is it more reflective of all the quarters in 2024? Or is there a step down in fourth quarter 'twenty four that we should think about continuing into 2025? Speaker 200:27:38Yes. I'll start out and then I'm going to hand this off to Joe. If you take a look at the last several years, I think the base business has been relatively steady. We've got some legacy brands that continue to erode. When we look at our base business, our core four, it's been pretty consistent. Speaker 200:28:00Joe, if you wanted to add to that, please. Speaker 300:28:03Yes. And I think when we look at the first quarter, the first quarter is always going to be a little bit lower, right, because of rate resets that go through our P and L. But I think you can look at the full year 2024 and that's more representative of the true business. Speaker 700:28:23Okay. So none of the products you would say have kind of reset at lower levels. I mean, mostly I'm thinking QBREXZA and Accutane are the main drivers there. Speaker 200:28:35Yes. QBREXZA continues to perform well for us. We continue to see script growth year over year. And it's holding very solid. It obviously has some new competition out there. Speaker 200:28:50But again, the prescriptions continue to show very good positive signs. Again, when you look year over year, we're growing that product. With Accutane, as we've stated in the past, there were a couple new entries towards the second and third quarter of twenty twenty four. We did see some slowdown with Accutane. We've stabilized that business relatively well and we believe we're going to have good performance with Accutane. Speaker 700:29:23Okay, great. And just one accounting question. I see the loss recovery of 4,553. Was that in fourth quarter? Is that related to the cyber attack? Speaker 700:29:38And also on the accounting side, the $15,000,000 approval milestone, how should we think about that being I thought we may see it expensed in the fourth quarter, but it doesn't look like it. How should we account for that going forward? Speaker 300:29:53Right. So to your first question, Scott, the $4,600,000 crypto, it was the recovery. We received the cash in December. So we're happy to put that through our P and L. And for the second question, the $15,000,000 we are able to capitalize that as an intangible asset and we will amortize that over the life of the patent, which is through 02/1939. Speaker 700:30:18Okay. And will that be amortized through the acquired intangible assets line, which is now broken it out or it will be lower down? Speaker 300:30:27No, it will be right in that line. Speaker 700:30:31Okay, great. Thank you for taking the questions. Speaker 300:30:34You're welcome. Operator00:30:35And the next question comes from Brandon Folkes with Rodman and Renshaw. Please go ahead. Speaker 800:30:43Hi, thanks for taking my questions and congratulations on all the progress. Maybe just two from me. Firstly, how do you think about pricing across the portfolio? Obviously, talking about more the legacy portfolio here in 2025? And then just kind of with the Amrosy launch, with the operating leverage you do have in your business, how do you think about capital allocation in 2025 and maybe beyond that as well? Speaker 800:31:13Thank you. Speaker 200:31:16Sure. Joe, would you like to take that? Speaker 300:31:20Sure. Calvin, as far as capital allocation, we're good with cash. We're very comfortable with our cash at this point. And can you talk can you speak to the other part of the question, please? Speaker 800:31:41Pricing across the base business or legacy portfolio in 2025, just sort of what are you seeing? Obviously, there's competitor interaction. So maybe just whether you want to go product by product or just sort of holistically across the portfolio, how do we think about kind of net pricing in 2025? Speaker 300:31:59So in 2025 go ahead, Claude. Speaker 200:32:03Yes. I mean, just generally, Brandon, with our legacy brands, when we look at ExoDerm and TargaDox, I think our pricing is going to be holding steady. We don't see much of a difference between one year to the next. The fact is those brands do have their competitive generics out there, especially with Targetox. So there's some erosion in the volume of the scripts more so than it is a pricing game with that. Speaker 200:32:41The one benefit is too with ExelDerm is we no longer have the obligation of paying royalties, so our margins for that product have actually gotten better. And then in terms of our remainder, our Core four as I've been calling it in 2024, we believe that net pricing should remain the same as you've seen. Operator00:33:12And the next question comes from Jason Wits with Roth Capital. Please go ahead. Speaker 900:33:18Hi. Thanks for taking the questions. In terms of sort of the milestones for the MROC launch that you guys are looking for internally, at least the things that I guess the bottlenecks, I mean reimbursement and getting into formulary, I would think would be sort of the main things to track, obviously, at least from our checks and physicians, there seems to be a lot of interest in the drug from the physician side. But I assume just that logistics of those other two items are kind of what's going to determine the outlook for 2025. Is that the right way to think about it? Speaker 200:33:53Yes. I think you're tracking correctly. I think there were two areas that we need to focus in on. One was supply and we're glad to say that we've got ample supply and more supply on the way. So we feel real good with that. Speaker 200:34:08The distribution part has been taken care of and the backup supplies again are we're in a good position there. So I think you can put that one on the side. Secondly, in terms of getting more formulary coverage, we feel really good. And the progress that we've done already, I think, shows a good indicator in where things are going. We've had great conversations with all the major plans. Speaker 200:34:37And I keep saying it, but it's so meaningful. These small molecules, there's not too many head to head comparisons. And when you're able to demonstrate statistical significance with a highly efficacious product, the plans are certainly interested and we feel very good in terms of being able to get on these formularies. The one area is like Louis just said earlier, it takes anywhere between twelve to eighteen months and we will see good progress on a quarterly basis and better coverage as we go. So it's have a little patience in this game, but on all accounts it looks very promising from that point as well. Speaker 900:35:28Okay. That's helpful. Thank you. And I guess you put out $100,000,000 international opportunity for Amorosi. Is that something that you're going to look to outlicense at some point? Speaker 900:35:40I assume that's kind of the goal here or how should we think about that? Speaker 200:35:45Yes. In terms of finding the right partner to out license to is exactly what we're looking at. We certainly want to focus our efforts here in The United States. We've got a real good handle on that and that's where our focus is going to be. But our business development strategy is to out license this. Speaker 200:36:08And I think as we continue to see early success onward in 2025, I think it makes it even that much more tempting for partners outside to look at Neurosy as a very viable product on an international basis. Speaker 900:36:28Got it. Thanks. I'll jump back in queue. Operator00:36:33And the next question comes from Talpit Patel with B. Riley Securities. Please go ahead. Speaker 1000:36:39Yes. Hey, good afternoon and thanks for taking the questions. Maybe a few on the market access and launch related questions. You mentioned that the peak coverage for MROCI, you would expect twelve to eighteen months from the day of the launch. I guess what exactly is the peak coverage percentage? Speaker 1000:37:03That's the question number one. And then the second question is in terms of the covered lives, you gave a new updated 204% number for the different groups. What percentage of those are unrestricted versus single step edits? Speaker 200:37:27Thanks, Kelpit. Louis, would you like to take that one, please? Speaker 500:37:33Sure. Hi, Kelpit. It's Lou, by the way. Thanks for the call and thanks for the question. So peak coverage, again, trying to get ahead of it is maybe doing a disservice to what we're trying to do early on because I don't want to give you a number right now, twelve to eighteen months down the road. Speaker 500:37:50All I can say is we've prepped the market early fall through today and right now about 20% commercial coverage is where the forecast should be, actually ahead of forecast in my opinion. I expect them ROESY because again we keep on talking about head to head studies and demand. I really believe this will be a really good product to the market rosacea and we will get the coverage that we anticipated. But just give us a few months to get out there with the field force and we can report back number one. Number two, the 20% commercial coverage and that includes federal employees and health exchange out of the one hundred and eighty eight million lives. Speaker 500:38:30There's a mixed bag of unrestricted access and restricted So the good news is the payer response has been very positive and there are some payers that are actually adopting the Merosi currently in an unrestricted position with no utilization management and that is prior authorization and no step. So the response has been very well received. Again, give us some time as the market access team they get out there once we get the demand from the field. That is definitely going to help our discussions long term. But just give us a few more months and we will report back, okay? Speaker 1000:39:04Okay, got it. And a couple of follow ups here. Is the step edits that's being mandated by some of these payers, should we assume that that's a generic ratio or does it also include off label antibodies? Speaker 500:39:21Primarily, the payer response has been if to get to them, Rosy, if there's going to be a step edit, it's going to be through generic oral agent. It could be minocycline and or doxycycline. The drug policies will vary, but generic oral agents would be the step. Speaker 1000:39:42Got it. Okay. And then last question for me. After you guys announced your pricing and launched the drug here, has there been any pricing moved by Galderma for their branding ratio? Speaker 200:39:58Yes. Actually, we have not seen any market movement in terms of pricing, Calcutt, since we've launched. Okay. Since we've announced. Speaker 1000:40:06Okay. Got it. Thank you very much for taking the questions. Operator00:40:13This concludes our question and answer session. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.Read morePowered by