NASDAQ:DERM Journey Medical Q2 2023 Earnings Report $6.25 +0.04 (+0.64%) Closing price 04/17/2025 04:00 PM EasternExtended Trading$6.23 -0.02 (-0.32%) As of 04/17/2025 04:40 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-$0.46Consensus EPS -$0.34Beat/MissMissed by -$0.12One Year Ago EPSN/AJourney Medical Revenue ResultsActual Revenue$17.17 millionExpected Revenue$14.81 millionBeat/MissBeat by +$2.36 millionYoY Revenue GrowthN/AJourney Medical Announcement DetailsQuarterQ2 2023Date8/8/2023TimeN/AConference Call DateTuesday, August 8, 2023Conference 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)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Journey Medical Q2 2023 Earnings Call TranscriptProvided by QuartrAugust 8, 2023 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to Journey Medical's Second Quarter 2023 Financial Results and Corporate Update Conference Call. At this time, all participants are in 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 the call will be available approximately 1 hour after the end of the call for approximately 30 days. I would like now to turn the call over to Mr. Operator00:00:37Matt Blasey of CORE IR, the company's Investor Relations firm. Please go ahead, sir. Speaker 100:00:43Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team Are Claude Morawy, Co Founder, President and Chief Executive Officer Joe Benesch, Interim Chief Financial Officer Doctor. Sarene Sajani, Vice President, Research and Development and joining us for the Q and A session will be Doctor. Neel Bhatia, Director of Clinical Dermatology at Therapeutics 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. Forward looking statements involve risks and other factors and may cause actual results to differ materially from those statements. Speaker 100:01:30For 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 8 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 Journey 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. The content of this call contains time sensitive information that is accurate only as of today, August 8, after this call. Speaker 100:02:26It is now my pleasure to turn the call over to Claude Monrawi, Co Founder, President and Chief Executive Officer of Jurnee Medical. Speaker 200:02:33Thanks, Matt. Good afternoon and thanks to everyone for joining our Q2 2023 conference call Corporate Update. This is an exciting time for Journee Medical. Our commercial business has seen a strong rebound this quarter. And as we recently announced our Phase 3 trials for DFD-twenty nine treatment for rosacea achieved And we'll then be joined by our Vice President of Research and Development, Doctor. Speaker 200:03:13Srini Sijidi, who will present this clinical data in greater detail. Immediately following the presentation, We will review our 2nd quarter results and open the line for questions. For the benefit of those on the call who are following our slides, please note that those slides will only be used in the section of the call where Doctor. Siggity is reviewing the data from the Phase 3 trials. We are very pleased with Positive results of our 2 Phase 3 clinical trials evaluating DFD-twenty 9 for the treatment of rosacea, which demonstrated statistical superiority over both Oracea and placebo. Speaker 200:04:01This is a significant milestone for Journey Medical and potentially the broader dermatology community. There were approximately 4,000,000 prescriptions written for rosacea in 2022 according to Symphony Health prescription data. Based on these positive study results, We plan on submitting a new drug application for DfD-twenty nine in the second half of twenty twenty three. If approved by the FDA, we believe that DfD-twenty nine has annual peak sales potential of $300,000,000 globally. With these clinically meaningful outcomes, DfD-twenty 9 has the potential to become the new treatment paradigm for the millions of patients suffering from rosacea as the lowest dose oral collaboration between Journey Medical, Doctor. Speaker 200:05:07Reddy's, the investigators and all the others that have been involved. We believe the potential approval of DFD-twenty 9 will be a transformational event for Journee. At this point, I would like to turn the call over to Doctor. Sijidi to discuss the results of the Phase 3 data in more detail. I will follow-up to discuss this market opportunity and our strategy on becoming the market leader in this space. Speaker 300:05:39Thank you, Claude. I would like to begin by reviewing the highlights from the Phase 3 for DFT-twenty nine top line data readout. I would also like to refer investors to the investor presentation on our website, which will have slides supporting my comments here in more detail. Journey Medical, in collaboration with Doctor. Reddy's, has conducted 2 Phase 3 studies for DFT-twenty nine. Speaker 300:06:09The Phase 3 studies had the following key design elements. Each study enrolled approximately 320 patients with moderate to severe papillopustular rosacea In a 3:3:2 randomization to DFT-twenty nine, Oracea Placebo. The first study, MBOR 1, enrolled all patients in the USA, while the second study, MBOR 2, Enrolled patients in a ratio of approximately 70 is to 30 in the U. S. And Germany. Speaker 300:06:47Of the total of approximately 6 40 patients in the two trials, approximately 540 patients were white Caucasians, while approximately 100 patients were of darker skin colors. All the subjects had an IGA grade of 3 or 4 and an inflammatory lesion count of 15 to 60 at study entry. Subjects were adequately washed out of any previous medication they were taking before starting the study treatments. Thus, the efficacy seen in these studies can be attributed to the study medication and not to any confounding or previous medication. The study treatments were assessed on 2 co primary endpoints. Speaker 300:07:371st, Proportion of subjects with IgA treatment success second, reduction in total inflammatory lesion count. The results show that DFT-twenty nine was statistically significantly superior to both placebo and oresia with 16 weeks treatment duration. The proportion of subjects that showed IgA treatment success was 65% for DFT-twenty nine, 46.1% for Auracea and 31.2% for placebo in MBOR 1. The P value for the difference between DFT-twenty 9 and Oracea was 0.014, while it was less than 0.001 against placebo. In MuR2, the proportion of subjects that showed IGA treatment success was 60.1% for DFT-twenty nine, 31.4% for Orescia and 26.8 percent for placebo. Speaker 300:08:42The P values were less than 0.001 for DFT-twenty 9 against both Orescia and placebo. In MUR1, the reduction in total inflammatory lesion count was 21.3 lesions for DFT-two thousand nine hundred and fifteen point nine for Orescia and 12.2 lesions for placebo. The P values were less than 0.001 for DFT-twenty 9 against both oresia and placebo. In Mv OR2, the reduction in total inflammatory lesion count was 18.4 lesions for DFT-twenty nine, 14.9 lesions for oresia and 11.1 lesions for placebo. The P values were less than 0.0 1 for DFT-twenty 9 against both Auracea and placebo. Speaker 300:09:37As can be seen from the data, DFT-twenty nine has consistently outperformed both ORACIA and placebo on the 2 key endpoints in both studies. DFT-twenty nine has shown statistically significant reduction of erythema in both studies Compared to placebo, DFT-twenty nine has also demonstrated statistically significant improvement in quality of life Against placebo, with regards to 2 very commonly used quality of life tools, the DLQI, Dermatology Quality of Life Index, which is a general quality of life tool used across dermatology trials and a rosacea specific quality of life Finally, we are pleased to say that DFT-twenty nine also has So on rapid onset of action, that is, it has shown statistically superior efficacy or placebo on both IGA success and lesion count reduction from week 2 onwards, which is a very significant achievement considering these were monotherapy studies. On the safety front, DFT-twenty nine was found to be safe and well tolerated in both the studies with the adverse event rates being close to placebo. These results indicate the possibility of TFT-twenty nine Being the new standard of care in rosacea and also being the best in class therapy, it is likely to be perceived As a safe minocycline formulation compared to other formulations because of the low and fixed dose, We anticipate DFT-twenty nine to capture significant market share upon its launch based on the significant differentiators it brings to the table. Speaker 300:11:38I will now hand it back to Claude to discuss our 2nd fiscal quarter results in more detail. Thank you. Speaker 200:11:49Thank you, Doctor. Sijidi. I would like now to turn our attention to the improving results in our commercial operations for the second quarter. As discussed on our last call with investors, our objective was to see continued sequential growth in revenues throughout this year and to achieve positive non GAAP adjusted EBITDA for fiscal year 2023. The key metrics for the Q2 surpassed our internal expectations, generating 17 point Some key highlights noteworthy of mentioning. Speaker 200:12:39Our leading core product, QBREXZA led the way with net sales of $8,000,000 in Q2 compared to $4,000,000 in Q1, which is an outstanding 97% increase in addition to achieving a new quarterly all time high for the brand. Accutane currently, our 2nd highest volume core product in our portfolio had an impressive gain as well. Accutane had net sales of $5,500,000 in Q2 versus net sales $4,600,000 in Q1 of 2023, which is a 20% increase. In our 3rd and 4th position of priority, we saw sequential increases in Amzik net revenue of 15% and ZILCY of 82% versus their Q1 results. We expect these trends to continue as we build momentum. Speaker 200:13:45Our legacy brands, which are Exelderm, TargaDox and Zimino continue to see anticipated erosion and combined only account for 8% of our total revenue in Q2 2023. I'd like to congratulate our commercial sales and marketing teams for remaining focused and executing our strategic plan. Journey continues making great strides towards the guidance that we gave during our 2022 10 ks earnings call, in which is achieving non GAAP adjusted EBITDA positive for calendar year 20 Our entire organization has taken the necessary steps in becoming more efficient Journey has successfully reduced SG and A expenses in Q2 2023 by over $3,000,000 compared to Q2 2022. We remain steadfast in our efforts and well on track of achieving a projected reduction of over $12,000,000 in SG and A spend this calendar year. Important to note, not only have we been able to implement the appropriate expense reduction efforts, We also were able to achieve revenue growth in parallel. Speaker 200:15:19We are certainly trending towards meeting our financial objectives and continue to expect this trend to continue into the second half of twenty twenty three. Finally, I am pleased to announce that we have paid off the entire debt facility we had with EastWest Bank. Jurney now has 0 bank debt. With that, I'll now turn the call over to Joe, who will review our financial results for the Q2. Speaker 400:15:51Thank you, Claude, and hello, everyone. I will now review The 2nd quarter financial results for 2023. As Claude mentioned, total net revenues for the Q2 of 2023 were $17,200,000 41 percent increase from $12,200,000 in the 1st quarter and a slight decrease of $1,100,000 from the prior year quarter. The decrease from the prior year quarter is primarily due to lower unit volumes from our legacy products, Targetox, Zimino and Exoderm, substantially driven by continued generic competition for Targetox. These results were offset by an increase in net product revenues from our 4 core products, QBREXZA, Accutane, And Zeke and Zeke, primarily due to increased unit volumes as a result of our focused sales and marketing emphasis on these products, which led to 19% growth for these products combined from the prior year quarter. Speaker 400:16:53These products combined reflect approximately 92 percent or $15,600,000 of the company's total product revenues for the Q2 of 2023. R and D expenses decreased by 32% from the prior year quarter related to lower clinical trial SG and A expenses decreased by 20% from the prior year quarter. The decrease is mainly due to our expense reduction efforts, primarily in sales and marketing. During the last quarter of 2022, We implemented a cost reduction initiative designed to improve operational efficiencies, optimize expenses and reduce overall costs. The initiative is intended to reduce SG and A expenses to better align costs with revenues being generated. Speaker 400:17:46In connection with this cost reduction initiative, we executed a headcount reduction to our sales force and implemented marketing and other cost cuts. The impact of this cost reduction initiative is expected to result, as Claude mentioned, in a reduction of greater than $12,000,000 of annual SG and A expenses. In the Q2 of 2023, we recorded $3,100,000 non cash impairment loss towards the Xamino intangible asset. Based on Ximino's current net product revenue and gross profit levels, we revised the financial outlook for Ximino, resulting in lower projected sales and net cash flows for future periods. We assess this revised forecast and determined that the revision constituted a triggering event. Speaker 400:18:34We reviewed the undiscounted future cash flows identified for Zanino and the results of the analysis indicated that the carry amount of the Zimino intangible asset on our balance sheet was not expected to be recovered. GAAP net loss to common shareholders was $8,400,000 or $0.46 per share basic and diluted for the Q2 of 2023 compared to a GAAP net loss of $10,100,000 or $0.57 per share basic and diluted for the Q1 of 2020 $7,500,000 or $0.43 per share basic and diluted for the Q2 of 2022. Our non GAAP adjusted EBITDA for the Q2 of 2023 resulted in a net loss of $600,000 were $0.04 per share basic and diluted compared to an adjusted EBITDA net loss of $5,300,000 or $0.30 per share basic and diluted for the Q1 of 2023 and an adjusted EBITDA net loss of $2,600,000 or $0.15 per share basic and diluted for the Q2 We are well on our way to becoming non GAAP adjusted EBITDA positive in 2023. At June 30, 2023, we had $17,000,000 in cash and cash equivalents and restricted cash as compared to $26,100,000 at March 31, 2023. At December 31, 2022, We had $32,000,000 in cash and cash equivalents. Speaker 400:20:11From a cash burn perspective, in May 2023, we paid down $10,000,000 of our term loan and our $3,000,000 revolver with East West Bank. Subsequently, in July of 2023, we voluntarily paid off the entire $10,000,000 Outstanding East West Bank Term Loan, effectively terminating the entire East West Bank facility. We therefore have no further obligations to East West Bank. We were able to pay off all of our East West Bank debt without any additional dilution to the company. Thank you very much. Speaker 400:20:44And now I'll turn Speaker 500:20:45it back to Claude. Speaker 200:20:48Thank you, Joe. In summary, I'd like to recap the highlights discussed First, DFD-twenty 9 achieved outstanding results. DFD-twenty 9 showed The NDA filing in Q4 2023 is on schedule. Our Phase 1 sub antimicrobial data suggests suitable long term usage. And if approved, DFD 29 has sales potential over $300,000,000 globally. Speaker 200:21:372nd, our Q2 2023 financial results rebounded from Q1. In Q2, we were up 41% over Q1 net sales, over 90% of revenue in our for promoted products. 3rd, the East West Bank full debt payoff happened in July. We are confident in our ability to have enough cash to see DFD-twenty 9 through approval. 4th, we are targeting operational profitability, non GAAP adjusted by end of this year The R and D expense is winding down with completion of our Phase 3 studies. Speaker 200:22:30And finally and 5th, our BD team continues to be opportunistic in looking at various on out licensing efforts with our current product portfolio and as well as with DFD-twenty 9 and its Operator00:23:52Our first question today comes from Scott Henry of ROTH Capital. Please go ahead. Speaker 600:23:58Thank you. Good afternoon. Tremendous improvement from the Q1. I'm sure It was tough making a lot of those cuts, but I do think it was instrumental to making the company viable in the long term. So I commend you and your team on that, Claude. Speaker 600:24:22Shifting gears, I'm going to start with the quarter, then I do have some DFD 29 questions. First, my assumption would be that when you paid off the loan that was all out of restricted cash. Is that correct? Speaker 200:24:38Joe, would you like to take that please? Speaker 400:24:41Yes, Scott. We had $8,750,000 of We took the cash on the books and it was definitely paid off with that. Speaker 600:24:49Okay, excellent. And then Your target of being EBITDA positive for the year still requires a lot of work because You got to make money in the second half, but you also have to work down some of the loss you started with in the Q1. To do that, do you expect that to be driven by higher revenues or lower expenses or a little bit of both? Speaker 500:25:21Yes. Thanks, Scott. Speaker 200:25:23Go ahead, Joe, please. Speaker 500:25:26It's going to be a little bit Speaker 400:25:27of both, Scott. So The Q2 still had some residual expenses in there from the cuts, right? So April May still had some higher We expect to be sequentially better. Speaker 600:25:51Okay, great. Now I just want to shift to DSD-twenty 9. You told us what your peak sales would be. Could you comment on how long you expect it to take to reach peak sales? This category, does it tend to be rapid uptake or what kind of trajectory do we typically see? Speaker 200:26:12Sure, Scott. Yes. In terms of uptake and launching DFD-twenty 9, we plan on Doing that in early 2025, a few months after we get approval hopefully from the FDA. In terms of how quickly to the peak sales numbers, typically you're going to be looking between 2 to 3 years as the peak annual sales ramp up. We're going to be looking at this asset going Head to head using what we hope to be a very rich package insert that FDA has approved, we'll be able to go and start to change the habits of utilizing Oracea as the gold standard and starts to switch that over To DFD-twenty 9, what's key with this asset is the ability of us not just sticking in the oral Systemic marketplace, but this drug candidate DFD-twenty 9 has the ability to go into the topical market, which has a much greater potential. Speaker 200:27:21So you're looking at 4,000,000 prescriptions written last year, oral And topical and that market is right in our sweet spot. We call on Doctors that prescribe Oracea, we already cover 90% of those that are currently prescribing Oracea in the last 12 months, just to give you some background. Speaker 600:27:46Okay. And just following up on that, because I think you're correct. I believe The rosacea market is about 90% topical and maybe 10% oral, which is oracea. In the acne market, orals have done very well. If we think about the acne market, what percent It is oral versus topical. Speaker 600:28:11So we get a sense of the ability to expand into that topical market with a better product offering. Speaker 200:28:19Yes. In terms of the number off the top of my head, I can get back to you on the exact size of oral versus topical Speaker 300:28:27in the acne Speaker 200:28:28Irina, but you're right about that percentage. It holds true on the rosacea side. So about 360 of the topical. So very close to those percentages. Speaker 600:28:51Okay. And then just the final question on the balance sheet. How comfortable are you with your cash balance? Obviously, at the right time, you would probably consider raising Some more equity, but I'm trying to get a sense of how flexible are you? Are you comfortable that you don't have to raise it down here and you may have a path to get Pretty close to breakeven from here as well. Speaker 200:29:18Yes. I'll start with this one, Joe. Yes. So far, like you said, we've had an exceptional second quarter. We've really cut our losses dramatically. Speaker 200:29:30Adjusted EBITDA at $600,000 So the breakeven is within a throw away. So We expect to be able to continue with operations. We're not looking to raise Any equity funding whatsoever, we are looking at debt facilities. Certainly, I think that would be proper to do. But right now, in terms of being operationally profitable, We're at that point where our revenues and where our SG and A is falling allows us the ability To go for all the way through the end of 2024 as a matter of fact, Scott. Speaker 600:30:16Okay, great. I'll jump back in the queue. Thank you for taking the questions. Operator00:30:24Our next question comes from Kalpit Patel of B. Riley. Please go ahead. Speaker 700:30:30Yes. Hey, Good afternoon and congrats on clearing the Phase 3 studies for DfD-twenty 9. Maybe I'll start with A couple of questions on this asset. You obviously beat both placebo and Auracea in the Phase 3 Maybe give us a sense of how reflective were the patients Enrolled in the trial compared to the real world population that gets Auratia today? Speaker 200:31:07Sure. I'll tell you, I think Doctor. Sigadie could take that and talk about the And we also have a guest investigator dermatologist, Doctor. Neel Bhatia, and Perhaps you can follow-up to Doctor. Srini's comments. Speaker 300:31:29Thanks, Claude. And that's a great question, Calcutt. The inclusion exclusion criteria that we had on these studies were very much reflective of the real world population for Rosacea. The kind of IgA grades and the lesion counts at baseline that we used, Those are the common kind of patients that providers see when they have to prescribe oral drug. Having said that, I'll transfer the question to Neil. Speaker 300:32:04Neil, could you please explain a little more? Speaker 500:32:11Yes. Hi there. Can you guys hear me okay? Speaker 200:32:14Yes, we can. Speaker 500:32:15Hi, everybody. Yes. I'm Doctor. Neil Batem in San Diego. One of the investigators for the study, I've worked with Journey as well as Doctor. Speaker 500:32:24Reddy's labs for many years, just as Aside, I think commercially as a dermatologist, we have not been seeing much support of Oration from Galderma, Neither they're generic nor they're branded in the past year or so due to their inability to cover the market. That's In turn, led to a downturn in the amount of oral treatments for rosacea that have been considered to be safe Or effective. By contrast, we've seen an upturn in the amount of topical products like Epsilay, the demise of But even though sales are flat, and I think to the point that commercially, we see a lot of rosacea patients who are tired of applying bad vehicles to their face, which is already hypersensitive. They're concerned about the photosensitivity of Higher doses of antibiotics like doxycycline. And minocycline, until now, unfortunately, a lot of the brands have fell by the wayside. Speaker 500:33:27So seeing this dose of minocycline come to fruition, as well as what we saw in the trials, I think this could actually have a very strong foothold in gaining that spot for oral treatment as a standard. I think the other component to rosacea patients is Many of them are otherwise healthy. They're not on other medications. They again would prefer a pill And something orally to minimize the labor involved with treating topically. So I think some of those would fit very well into the potential for the rosacea market. Speaker 500:34:03I know that a lot of our trial patients did not want to let this drug go out of their hands. They were So pleased with the way things turned out for them that they were actually sad the trial ended. Speaker 700:34:16Okay, understood. And Doctor. Bhatia, since We have you here today. I guess, can you give us an understanding of how minocycline capsules Maybe used today in the market for rosacea, are they used commonly as an off label treatment Or is it more or less reserved just for Oracea? Speaker 500:34:42Yes. I mean, the doxycycline Let me sit back. The tetracycline family as a whole impacts a number of processes that start the inflammatory cascade of rosacea. That's been understood for many years in terms of different proteins that get cleaved, the cathelicidin pathway and Without getting too scientific, a lot of the cell lines that are progressing the process of rosacea. So Both doxycycline and minocycline have been proven effective at an optimal dose because for one there's no bacterial Target. Speaker 500:35:17So there's no action as an antibiotic. It's more an anti inflammatory dose. But the problem is above a certain threshold, The medication, whether it's doxycycline or minocycline can have antibiotic properties, which can lead to consequence down the road, which is what led to the cultivation of Oracea at that dosage. Now the way minocycline will work At this dosage in the DFD product, DFD 29 product, it will be in a very similar directed fashion against The process that makes rosacea and the safety of it will allow it to be used again year long, if you will, Whatever indication comes from it. The long term studies for 52 weeks and everything else that goes along with this class of drugs tells us that we have a safety profile we can rely on. Speaker 500:36:12So I think in the end, rosacea patients, you think about your average 30 some year old, they have a high co pay, high deductible. I'd rather treat them with something that I know will work for the long run and not have to see them back in the office to fine tune them and let them do well on the medication that's going to serve the purpose of treating the process of their disease, not So I hope that makes sense. I don't want to Speaker 400:36:41be specific for you. Speaker 700:36:43No, that's helpful. And this one, I believe, is an extended release or it's a special formulation of minocycline. Do you see any advantages here in terms of safety profile or tolerability profile versus Just using generic immediate release minocycline tablets or capsules? Speaker 500:37:04I mean minocycline is a synthetic drug compared to doxycycline, which is natural. So doxycycline's effects are more immediate. They cause headaches, photosensitivity, GI distress, Menocycline over the long term at high doses can cause vertigo and lupus like effects and Kidney issues and things that are dose limiting at higher doses. So with this dose, we are less likely to see Any long term chronic issues that were once a stigma related to higher doses of minocycline. So minocycline by nature It's better absorbed in the fat and the pilosubaceous unit and the middle layers of the skin, which is why it was always a better drug for acne From a logistics standpoint and this might sound selfish, dermatologists always looked at minocycline as Our drug, because a lot of the primary care physicians and others who were treating rosacea and acne, they were sending the patients 2 of us on Doxy and we'd say, well, let's switch it up. Speaker 500:38:16So there's going to be a little bit of possession that the dermatologists will feel When they get their hands on this. Speaker 700:38:26All right. And maybe one last market opportunity related question here for you, Assuming this drug gets approved, what proportion of your rosacea patients would you prescribe this drug? And what proportion will you continue to use Oresia? Speaker 500:38:44Sure. I mean, I'll be honest, I'm an early adopter. So when I get something new and I get my hands on something, I pretty much flood everybody with it. There are going to be those who might be tied to Oracea. There are going to be others who will take a chance on minocycline. Speaker 500:39:02And in all fairness, there's probably going to be a few Dermatologists will say, no, I'm not comfortable with nocycline. So all of that will be up to Journee to Kind of bring all those mindsets forward and approach the marketing that way. I'm an educator myself. I speak at conferences on Rosacea published textbooks. I would have no problem talking about safety first and talking about here's an efficacious approach to the process I have rosacea with an oral route, and I would probably work on convincing my colleagues to maybe get off the ledge rather than We'll be concerned with what we used to know about your father's minocycline, if you want to call it that. Speaker 300:39:48Okay. Speaker 700:39:50And maybe one question for the company, the clinical trial itself. How did erythema fare in both of your studies? I believe in ORASIA's pivotal studies back in the day, we saw Speaker 200:40:15Srini, can you take that one, please? Speaker 300:40:18Sure, Claude. So, Calpet, you are right. Back in those days, Auratia had statistical significance against placebo on erythema in one of their studies, while the other one didn't show the significance, but during the NDA review process, I think the FDA did The impact on erythema as an important secondary endpoint and we found that both the studies have shown Statistical significance against placebo for DFT-twenty nine. But that's going to be one of our key messages on the NDA filing. Speaker 700:41:07Okay. If I could add to that Speaker 500:41:11just real quick and all of that is correct. The clinical erythema assessment That is done when you walk in the door as an investigator is often a marker of overall success. Keep in mind that's the patient, their number one concern is looking less red. So when you're looking at them when you walk in the door to assess their grading, The erythema assessment is included in your overall grade of improvement even though the papulon pustular count is still one of the more objective measures. So keep in mind, if people are not getting less red as a result of the post inflammatory The background of the Iradema, they're going to let you know. Speaker 700:41:56Okay. Thank you very much for taking the questions. Operator00:42:11With no further questions, this will conclude our question and answer session. The conference has now concluded. Thank you for attending today's presentation. You may nowRead morePowered by Conference Call Audio Live Call not available Earnings Conference CallJourney Medical Q2 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Journey Medical Earnings HeadlinesJourney Medical promotes Ramsey Alloush to COOApril 2, 2025 | markets.businessinsider.comJourney Medical Corporation Appoints Ramsey Alloush as Chief Operating OfficerApril 1, 2025 | globenewswire.comThey Won’t Tell You This About GoldInflation, digital currency, and government policy are quietly eating away at your savings — and most people won't realize it until it's too late. A new underground report, Gold’s Next Move, reveals why gold could be on the edge of a major breakout — and what you should be doing right now to protect your wealth before the next big move hits.April 18, 2025 | American Alternative (Ad)B.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.comJourney Medical reports FY24 EPS (72c) vs (21c) last yearMarch 28, 2025 | markets.businessinsider.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 8 speakers on the call. Operator00:00:00Good afternoon, and welcome to Journey Medical's Second Quarter 2023 Financial Results and Corporate Update Conference Call. At this time, all participants are in 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 the call will be available approximately 1 hour after the end of the call for approximately 30 days. I would like now to turn the call over to Mr. Operator00:00:37Matt Blasey of CORE IR, the company's Investor Relations firm. Please go ahead, sir. Speaker 100:00:43Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team Are Claude Morawy, Co Founder, President and Chief Executive Officer Joe Benesch, Interim Chief Financial Officer Doctor. Sarene Sajani, Vice President, Research and Development and joining us for the Q and A session will be Doctor. Neel Bhatia, Director of Clinical Dermatology at Therapeutics 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. Forward looking statements involve risks and other factors and may cause actual results to differ materially from those statements. Speaker 100:01:30For 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 8 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 Journey 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. The content of this call contains time sensitive information that is accurate only as of today, August 8, after this call. Speaker 100:02:26It is now my pleasure to turn the call over to Claude Monrawi, Co Founder, President and Chief Executive Officer of Jurnee Medical. Speaker 200:02:33Thanks, Matt. Good afternoon and thanks to everyone for joining our Q2 2023 conference call Corporate Update. This is an exciting time for Journee Medical. Our commercial business has seen a strong rebound this quarter. And as we recently announced our Phase 3 trials for DFD-twenty nine treatment for rosacea achieved And we'll then be joined by our Vice President of Research and Development, Doctor. Speaker 200:03:13Srini Sijidi, who will present this clinical data in greater detail. Immediately following the presentation, We will review our 2nd quarter results and open the line for questions. For the benefit of those on the call who are following our slides, please note that those slides will only be used in the section of the call where Doctor. Siggity is reviewing the data from the Phase 3 trials. We are very pleased with Positive results of our 2 Phase 3 clinical trials evaluating DFD-twenty 9 for the treatment of rosacea, which demonstrated statistical superiority over both Oracea and placebo. Speaker 200:04:01This is a significant milestone for Journey Medical and potentially the broader dermatology community. There were approximately 4,000,000 prescriptions written for rosacea in 2022 according to Symphony Health prescription data. Based on these positive study results, We plan on submitting a new drug application for DfD-twenty nine in the second half of twenty twenty three. If approved by the FDA, we believe that DfD-twenty nine has annual peak sales potential of $300,000,000 globally. With these clinically meaningful outcomes, DfD-twenty 9 has the potential to become the new treatment paradigm for the millions of patients suffering from rosacea as the lowest dose oral collaboration between Journey Medical, Doctor. Speaker 200:05:07Reddy's, the investigators and all the others that have been involved. We believe the potential approval of DFD-twenty 9 will be a transformational event for Journee. At this point, I would like to turn the call over to Doctor. Sijidi to discuss the results of the Phase 3 data in more detail. I will follow-up to discuss this market opportunity and our strategy on becoming the market leader in this space. Speaker 300:05:39Thank you, Claude. I would like to begin by reviewing the highlights from the Phase 3 for DFT-twenty nine top line data readout. I would also like to refer investors to the investor presentation on our website, which will have slides supporting my comments here in more detail. Journey Medical, in collaboration with Doctor. Reddy's, has conducted 2 Phase 3 studies for DFT-twenty nine. Speaker 300:06:09The Phase 3 studies had the following key design elements. Each study enrolled approximately 320 patients with moderate to severe papillopustular rosacea In a 3:3:2 randomization to DFT-twenty nine, Oracea Placebo. The first study, MBOR 1, enrolled all patients in the USA, while the second study, MBOR 2, Enrolled patients in a ratio of approximately 70 is to 30 in the U. S. And Germany. Speaker 300:06:47Of the total of approximately 6 40 patients in the two trials, approximately 540 patients were white Caucasians, while approximately 100 patients were of darker skin colors. All the subjects had an IGA grade of 3 or 4 and an inflammatory lesion count of 15 to 60 at study entry. Subjects were adequately washed out of any previous medication they were taking before starting the study treatments. Thus, the efficacy seen in these studies can be attributed to the study medication and not to any confounding or previous medication. The study treatments were assessed on 2 co primary endpoints. Speaker 300:07:371st, Proportion of subjects with IgA treatment success second, reduction in total inflammatory lesion count. The results show that DFT-twenty nine was statistically significantly superior to both placebo and oresia with 16 weeks treatment duration. The proportion of subjects that showed IgA treatment success was 65% for DFT-twenty nine, 46.1% for Auracea and 31.2% for placebo in MBOR 1. The P value for the difference between DFT-twenty 9 and Oracea was 0.014, while it was less than 0.001 against placebo. In MuR2, the proportion of subjects that showed IGA treatment success was 60.1% for DFT-twenty nine, 31.4% for Orescia and 26.8 percent for placebo. Speaker 300:08:42The P values were less than 0.001 for DFT-twenty 9 against both Orescia and placebo. In MUR1, the reduction in total inflammatory lesion count was 21.3 lesions for DFT-two thousand nine hundred and fifteen point nine for Orescia and 12.2 lesions for placebo. The P values were less than 0.001 for DFT-twenty 9 against both oresia and placebo. In Mv OR2, the reduction in total inflammatory lesion count was 18.4 lesions for DFT-twenty nine, 14.9 lesions for oresia and 11.1 lesions for placebo. The P values were less than 0.0 1 for DFT-twenty 9 against both Auracea and placebo. Speaker 300:09:37As can be seen from the data, DFT-twenty nine has consistently outperformed both ORACIA and placebo on the 2 key endpoints in both studies. DFT-twenty nine has shown statistically significant reduction of erythema in both studies Compared to placebo, DFT-twenty nine has also demonstrated statistically significant improvement in quality of life Against placebo, with regards to 2 very commonly used quality of life tools, the DLQI, Dermatology Quality of Life Index, which is a general quality of life tool used across dermatology trials and a rosacea specific quality of life Finally, we are pleased to say that DFT-twenty nine also has So on rapid onset of action, that is, it has shown statistically superior efficacy or placebo on both IGA success and lesion count reduction from week 2 onwards, which is a very significant achievement considering these were monotherapy studies. On the safety front, DFT-twenty nine was found to be safe and well tolerated in both the studies with the adverse event rates being close to placebo. These results indicate the possibility of TFT-twenty nine Being the new standard of care in rosacea and also being the best in class therapy, it is likely to be perceived As a safe minocycline formulation compared to other formulations because of the low and fixed dose, We anticipate DFT-twenty nine to capture significant market share upon its launch based on the significant differentiators it brings to the table. Speaker 300:11:38I will now hand it back to Claude to discuss our 2nd fiscal quarter results in more detail. Thank you. Speaker 200:11:49Thank you, Doctor. Sijidi. I would like now to turn our attention to the improving results in our commercial operations for the second quarter. As discussed on our last call with investors, our objective was to see continued sequential growth in revenues throughout this year and to achieve positive non GAAP adjusted EBITDA for fiscal year 2023. The key metrics for the Q2 surpassed our internal expectations, generating 17 point Some key highlights noteworthy of mentioning. Speaker 200:12:39Our leading core product, QBREXZA led the way with net sales of $8,000,000 in Q2 compared to $4,000,000 in Q1, which is an outstanding 97% increase in addition to achieving a new quarterly all time high for the brand. Accutane currently, our 2nd highest volume core product in our portfolio had an impressive gain as well. Accutane had net sales of $5,500,000 in Q2 versus net sales $4,600,000 in Q1 of 2023, which is a 20% increase. In our 3rd and 4th position of priority, we saw sequential increases in Amzik net revenue of 15% and ZILCY of 82% versus their Q1 results. We expect these trends to continue as we build momentum. Speaker 200:13:45Our legacy brands, which are Exelderm, TargaDox and Zimino continue to see anticipated erosion and combined only account for 8% of our total revenue in Q2 2023. I'd like to congratulate our commercial sales and marketing teams for remaining focused and executing our strategic plan. Journey continues making great strides towards the guidance that we gave during our 2022 10 ks earnings call, in which is achieving non GAAP adjusted EBITDA positive for calendar year 20 Our entire organization has taken the necessary steps in becoming more efficient Journey has successfully reduced SG and A expenses in Q2 2023 by over $3,000,000 compared to Q2 2022. We remain steadfast in our efforts and well on track of achieving a projected reduction of over $12,000,000 in SG and A spend this calendar year. Important to note, not only have we been able to implement the appropriate expense reduction efforts, We also were able to achieve revenue growth in parallel. Speaker 200:15:19We are certainly trending towards meeting our financial objectives and continue to expect this trend to continue into the second half of twenty twenty three. Finally, I am pleased to announce that we have paid off the entire debt facility we had with EastWest Bank. Jurney now has 0 bank debt. With that, I'll now turn the call over to Joe, who will review our financial results for the Q2. Speaker 400:15:51Thank you, Claude, and hello, everyone. I will now review The 2nd quarter financial results for 2023. As Claude mentioned, total net revenues for the Q2 of 2023 were $17,200,000 41 percent increase from $12,200,000 in the 1st quarter and a slight decrease of $1,100,000 from the prior year quarter. The decrease from the prior year quarter is primarily due to lower unit volumes from our legacy products, Targetox, Zimino and Exoderm, substantially driven by continued generic competition for Targetox. These results were offset by an increase in net product revenues from our 4 core products, QBREXZA, Accutane, And Zeke and Zeke, primarily due to increased unit volumes as a result of our focused sales and marketing emphasis on these products, which led to 19% growth for these products combined from the prior year quarter. Speaker 400:16:53These products combined reflect approximately 92 percent or $15,600,000 of the company's total product revenues for the Q2 of 2023. R and D expenses decreased by 32% from the prior year quarter related to lower clinical trial SG and A expenses decreased by 20% from the prior year quarter. The decrease is mainly due to our expense reduction efforts, primarily in sales and marketing. During the last quarter of 2022, We implemented a cost reduction initiative designed to improve operational efficiencies, optimize expenses and reduce overall costs. The initiative is intended to reduce SG and A expenses to better align costs with revenues being generated. Speaker 400:17:46In connection with this cost reduction initiative, we executed a headcount reduction to our sales force and implemented marketing and other cost cuts. The impact of this cost reduction initiative is expected to result, as Claude mentioned, in a reduction of greater than $12,000,000 of annual SG and A expenses. In the Q2 of 2023, we recorded $3,100,000 non cash impairment loss towards the Xamino intangible asset. Based on Ximino's current net product revenue and gross profit levels, we revised the financial outlook for Ximino, resulting in lower projected sales and net cash flows for future periods. We assess this revised forecast and determined that the revision constituted a triggering event. Speaker 400:18:34We reviewed the undiscounted future cash flows identified for Zanino and the results of the analysis indicated that the carry amount of the Zimino intangible asset on our balance sheet was not expected to be recovered. GAAP net loss to common shareholders was $8,400,000 or $0.46 per share basic and diluted for the Q2 of 2023 compared to a GAAP net loss of $10,100,000 or $0.57 per share basic and diluted for the Q1 of 2020 $7,500,000 or $0.43 per share basic and diluted for the Q2 of 2022. Our non GAAP adjusted EBITDA for the Q2 of 2023 resulted in a net loss of $600,000 were $0.04 per share basic and diluted compared to an adjusted EBITDA net loss of $5,300,000 or $0.30 per share basic and diluted for the Q1 of 2023 and an adjusted EBITDA net loss of $2,600,000 or $0.15 per share basic and diluted for the Q2 We are well on our way to becoming non GAAP adjusted EBITDA positive in 2023. At June 30, 2023, we had $17,000,000 in cash and cash equivalents and restricted cash as compared to $26,100,000 at March 31, 2023. At December 31, 2022, We had $32,000,000 in cash and cash equivalents. Speaker 400:20:11From a cash burn perspective, in May 2023, we paid down $10,000,000 of our term loan and our $3,000,000 revolver with East West Bank. Subsequently, in July of 2023, we voluntarily paid off the entire $10,000,000 Outstanding East West Bank Term Loan, effectively terminating the entire East West Bank facility. We therefore have no further obligations to East West Bank. We were able to pay off all of our East West Bank debt without any additional dilution to the company. Thank you very much. Speaker 400:20:44And now I'll turn Speaker 500:20:45it back to Claude. Speaker 200:20:48Thank you, Joe. In summary, I'd like to recap the highlights discussed First, DFD-twenty 9 achieved outstanding results. DFD-twenty 9 showed The NDA filing in Q4 2023 is on schedule. Our Phase 1 sub antimicrobial data suggests suitable long term usage. And if approved, DFD 29 has sales potential over $300,000,000 globally. Speaker 200:21:372nd, our Q2 2023 financial results rebounded from Q1. In Q2, we were up 41% over Q1 net sales, over 90% of revenue in our for promoted products. 3rd, the East West Bank full debt payoff happened in July. We are confident in our ability to have enough cash to see DFD-twenty 9 through approval. 4th, we are targeting operational profitability, non GAAP adjusted by end of this year The R and D expense is winding down with completion of our Phase 3 studies. Speaker 200:22:30And finally and 5th, our BD team continues to be opportunistic in looking at various on out licensing efforts with our current product portfolio and as well as with DFD-twenty 9 and its Operator00:23:52Our first question today comes from Scott Henry of ROTH Capital. Please go ahead. Speaker 600:23:58Thank you. Good afternoon. Tremendous improvement from the Q1. I'm sure It was tough making a lot of those cuts, but I do think it was instrumental to making the company viable in the long term. So I commend you and your team on that, Claude. Speaker 600:24:22Shifting gears, I'm going to start with the quarter, then I do have some DFD 29 questions. First, my assumption would be that when you paid off the loan that was all out of restricted cash. Is that correct? Speaker 200:24:38Joe, would you like to take that please? Speaker 400:24:41Yes, Scott. We had $8,750,000 of We took the cash on the books and it was definitely paid off with that. Speaker 600:24:49Okay, excellent. And then Your target of being EBITDA positive for the year still requires a lot of work because You got to make money in the second half, but you also have to work down some of the loss you started with in the Q1. To do that, do you expect that to be driven by higher revenues or lower expenses or a little bit of both? Speaker 500:25:21Yes. Thanks, Scott. Speaker 200:25:23Go ahead, Joe, please. Speaker 500:25:26It's going to be a little bit Speaker 400:25:27of both, Scott. So The Q2 still had some residual expenses in there from the cuts, right? So April May still had some higher We expect to be sequentially better. Speaker 600:25:51Okay, great. Now I just want to shift to DSD-twenty 9. You told us what your peak sales would be. Could you comment on how long you expect it to take to reach peak sales? This category, does it tend to be rapid uptake or what kind of trajectory do we typically see? Speaker 200:26:12Sure, Scott. Yes. In terms of uptake and launching DFD-twenty 9, we plan on Doing that in early 2025, a few months after we get approval hopefully from the FDA. In terms of how quickly to the peak sales numbers, typically you're going to be looking between 2 to 3 years as the peak annual sales ramp up. We're going to be looking at this asset going Head to head using what we hope to be a very rich package insert that FDA has approved, we'll be able to go and start to change the habits of utilizing Oracea as the gold standard and starts to switch that over To DFD-twenty 9, what's key with this asset is the ability of us not just sticking in the oral Systemic marketplace, but this drug candidate DFD-twenty 9 has the ability to go into the topical market, which has a much greater potential. Speaker 200:27:21So you're looking at 4,000,000 prescriptions written last year, oral And topical and that market is right in our sweet spot. We call on Doctors that prescribe Oracea, we already cover 90% of those that are currently prescribing Oracea in the last 12 months, just to give you some background. Speaker 600:27:46Okay. And just following up on that, because I think you're correct. I believe The rosacea market is about 90% topical and maybe 10% oral, which is oracea. In the acne market, orals have done very well. If we think about the acne market, what percent It is oral versus topical. Speaker 600:28:11So we get a sense of the ability to expand into that topical market with a better product offering. Speaker 200:28:19Yes. In terms of the number off the top of my head, I can get back to you on the exact size of oral versus topical Speaker 300:28:27in the acne Speaker 200:28:28Irina, but you're right about that percentage. It holds true on the rosacea side. So about 360 of the topical. So very close to those percentages. Speaker 600:28:51Okay. And then just the final question on the balance sheet. How comfortable are you with your cash balance? Obviously, at the right time, you would probably consider raising Some more equity, but I'm trying to get a sense of how flexible are you? Are you comfortable that you don't have to raise it down here and you may have a path to get Pretty close to breakeven from here as well. Speaker 200:29:18Yes. I'll start with this one, Joe. Yes. So far, like you said, we've had an exceptional second quarter. We've really cut our losses dramatically. Speaker 200:29:30Adjusted EBITDA at $600,000 So the breakeven is within a throw away. So We expect to be able to continue with operations. We're not looking to raise Any equity funding whatsoever, we are looking at debt facilities. Certainly, I think that would be proper to do. But right now, in terms of being operationally profitable, We're at that point where our revenues and where our SG and A is falling allows us the ability To go for all the way through the end of 2024 as a matter of fact, Scott. Speaker 600:30:16Okay, great. I'll jump back in the queue. Thank you for taking the questions. Operator00:30:24Our next question comes from Kalpit Patel of B. Riley. Please go ahead. Speaker 700:30:30Yes. Hey, Good afternoon and congrats on clearing the Phase 3 studies for DfD-twenty 9. Maybe I'll start with A couple of questions on this asset. You obviously beat both placebo and Auracea in the Phase 3 Maybe give us a sense of how reflective were the patients Enrolled in the trial compared to the real world population that gets Auratia today? Speaker 200:31:07Sure. I'll tell you, I think Doctor. Sigadie could take that and talk about the And we also have a guest investigator dermatologist, Doctor. Neel Bhatia, and Perhaps you can follow-up to Doctor. Srini's comments. Speaker 300:31:29Thanks, Claude. And that's a great question, Calcutt. The inclusion exclusion criteria that we had on these studies were very much reflective of the real world population for Rosacea. The kind of IgA grades and the lesion counts at baseline that we used, Those are the common kind of patients that providers see when they have to prescribe oral drug. Having said that, I'll transfer the question to Neil. Speaker 300:32:04Neil, could you please explain a little more? Speaker 500:32:11Yes. Hi there. Can you guys hear me okay? Speaker 200:32:14Yes, we can. Speaker 500:32:15Hi, everybody. Yes. I'm Doctor. Neil Batem in San Diego. One of the investigators for the study, I've worked with Journey as well as Doctor. Speaker 500:32:24Reddy's labs for many years, just as Aside, I think commercially as a dermatologist, we have not been seeing much support of Oration from Galderma, Neither they're generic nor they're branded in the past year or so due to their inability to cover the market. That's In turn, led to a downturn in the amount of oral treatments for rosacea that have been considered to be safe Or effective. By contrast, we've seen an upturn in the amount of topical products like Epsilay, the demise of But even though sales are flat, and I think to the point that commercially, we see a lot of rosacea patients who are tired of applying bad vehicles to their face, which is already hypersensitive. They're concerned about the photosensitivity of Higher doses of antibiotics like doxycycline. And minocycline, until now, unfortunately, a lot of the brands have fell by the wayside. Speaker 500:33:27So seeing this dose of minocycline come to fruition, as well as what we saw in the trials, I think this could actually have a very strong foothold in gaining that spot for oral treatment as a standard. I think the other component to rosacea patients is Many of them are otherwise healthy. They're not on other medications. They again would prefer a pill And something orally to minimize the labor involved with treating topically. So I think some of those would fit very well into the potential for the rosacea market. Speaker 500:34:03I know that a lot of our trial patients did not want to let this drug go out of their hands. They were So pleased with the way things turned out for them that they were actually sad the trial ended. Speaker 700:34:16Okay, understood. And Doctor. Bhatia, since We have you here today. I guess, can you give us an understanding of how minocycline capsules Maybe used today in the market for rosacea, are they used commonly as an off label treatment Or is it more or less reserved just for Oracea? Speaker 500:34:42Yes. I mean, the doxycycline Let me sit back. The tetracycline family as a whole impacts a number of processes that start the inflammatory cascade of rosacea. That's been understood for many years in terms of different proteins that get cleaved, the cathelicidin pathway and Without getting too scientific, a lot of the cell lines that are progressing the process of rosacea. So Both doxycycline and minocycline have been proven effective at an optimal dose because for one there's no bacterial Target. Speaker 500:35:17So there's no action as an antibiotic. It's more an anti inflammatory dose. But the problem is above a certain threshold, The medication, whether it's doxycycline or minocycline can have antibiotic properties, which can lead to consequence down the road, which is what led to the cultivation of Oracea at that dosage. Now the way minocycline will work At this dosage in the DFD product, DFD 29 product, it will be in a very similar directed fashion against The process that makes rosacea and the safety of it will allow it to be used again year long, if you will, Whatever indication comes from it. The long term studies for 52 weeks and everything else that goes along with this class of drugs tells us that we have a safety profile we can rely on. Speaker 500:36:12So I think in the end, rosacea patients, you think about your average 30 some year old, they have a high co pay, high deductible. I'd rather treat them with something that I know will work for the long run and not have to see them back in the office to fine tune them and let them do well on the medication that's going to serve the purpose of treating the process of their disease, not So I hope that makes sense. I don't want to Speaker 400:36:41be specific for you. Speaker 700:36:43No, that's helpful. And this one, I believe, is an extended release or it's a special formulation of minocycline. Do you see any advantages here in terms of safety profile or tolerability profile versus Just using generic immediate release minocycline tablets or capsules? Speaker 500:37:04I mean minocycline is a synthetic drug compared to doxycycline, which is natural. So doxycycline's effects are more immediate. They cause headaches, photosensitivity, GI distress, Menocycline over the long term at high doses can cause vertigo and lupus like effects and Kidney issues and things that are dose limiting at higher doses. So with this dose, we are less likely to see Any long term chronic issues that were once a stigma related to higher doses of minocycline. So minocycline by nature It's better absorbed in the fat and the pilosubaceous unit and the middle layers of the skin, which is why it was always a better drug for acne From a logistics standpoint and this might sound selfish, dermatologists always looked at minocycline as Our drug, because a lot of the primary care physicians and others who were treating rosacea and acne, they were sending the patients 2 of us on Doxy and we'd say, well, let's switch it up. Speaker 500:38:16So there's going to be a little bit of possession that the dermatologists will feel When they get their hands on this. Speaker 700:38:26All right. And maybe one last market opportunity related question here for you, Assuming this drug gets approved, what proportion of your rosacea patients would you prescribe this drug? And what proportion will you continue to use Oresia? Speaker 500:38:44Sure. I mean, I'll be honest, I'm an early adopter. So when I get something new and I get my hands on something, I pretty much flood everybody with it. There are going to be those who might be tied to Oracea. There are going to be others who will take a chance on minocycline. Speaker 500:39:02And in all fairness, there's probably going to be a few Dermatologists will say, no, I'm not comfortable with nocycline. So all of that will be up to Journee to Kind of bring all those mindsets forward and approach the marketing that way. I'm an educator myself. I speak at conferences on Rosacea published textbooks. I would have no problem talking about safety first and talking about here's an efficacious approach to the process I have rosacea with an oral route, and I would probably work on convincing my colleagues to maybe get off the ledge rather than We'll be concerned with what we used to know about your father's minocycline, if you want to call it that. Speaker 300:39:48Okay. Speaker 700:39:50And maybe one question for the company, the clinical trial itself. How did erythema fare in both of your studies? I believe in ORASIA's pivotal studies back in the day, we saw Speaker 200:40:15Srini, can you take that one, please? Speaker 300:40:18Sure, Claude. So, Calpet, you are right. Back in those days, Auratia had statistical significance against placebo on erythema in one of their studies, while the other one didn't show the significance, but during the NDA review process, I think the FDA did The impact on erythema as an important secondary endpoint and we found that both the studies have shown Statistical significance against placebo for DFT-twenty nine. But that's going to be one of our key messages on the NDA filing. Speaker 700:41:07Okay. If I could add to that Speaker 500:41:11just real quick and all of that is correct. The clinical erythema assessment That is done when you walk in the door as an investigator is often a marker of overall success. Keep in mind that's the patient, their number one concern is looking less red. So when you're looking at them when you walk in the door to assess their grading, The erythema assessment is included in your overall grade of improvement even though the papulon pustular count is still one of the more objective measures. So keep in mind, if people are not getting less red as a result of the post inflammatory The background of the Iradema, they're going to let you know. Speaker 700:41:56Okay. Thank you very much for taking the questions. Operator00:42:11With no further questions, this will conclude our question and answer session. The conference has now concluded. Thank you for attending today's presentation. You may nowRead morePowered by