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spk06: Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Journey Medical's fourth quarter and fiscal year 2022 financial results and corporate update conference call. At this time, all participants are in the listen-only mode. Should you need assistance, please signal conference questions by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you can press star then one on your telephone keypad. To withdraw your question, please press star then two. 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 one hour after the end of the call for approximately 30 days. I would now like to turn the call over to Matt Blasey of CoreIR, the company's investor relations firm. Please go ahead, sir.
spk01: Thank you, Anthony. Good afternoon, and thank you for participating in today's conference call. Joining from Journey Medical Corporation's leadership team are Claude Murawi, co-founder, president and chief executive officer, Joe Benesch, interim chief financial officer, Ramzi Aloush, general counsel, and Dr. Srini Sigidi, vice president of research and development. During this call, management will be making forward-looking statements, including statements that address Journey Medical's expectations for future performance or operational results. Forward-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-K and Form 10-Q, the Form 8-K 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 contents of this call contain time-sensitive information that is accurate only as of today, March 29, 2023. Except as required by law, Journey Medical disclaims any obligations 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 Marawi, co-founder, president, and chief executive officer of Journey Medical.
spk02: Thanks, Matt. Good afternoon, and thanks to everyone for joining our fourth quarter and fiscal year 2022 conference call. We are pleased with many of our accomplishments during our first full year as a public company. And although we faced a number of challenges, we look forward to continued revenue growth in 2023. We are also approaching significant clinical milestones for our Phase III clinical trial evaluating DFD29. We have achieved 100% enrollment in the clinical trials as of the beginning of January 2023. with an expected top-line data readout in the second quarter of 2023, which we expect to be followed by an NDA filing in the second half of 2023. In addition, we recently announced completion of treatment in our Phase I clinical trial assessing the impact of DFD29 on the microbial flora with no significant safety issues noted during the study. We also anticipate launching an additional product in the second half of 2023, which will be Journey Medical's ninth marketed dermatology product. Looking back on 2022, Journey reported record revenues for the fiscal year of $73.7 million, which is a 17% increase from the revenue reported for the prior year of $63.1 million. Fourth quarter revenue was $16 million, which was $1.6 million less than the fourth quarter of 2021. In addition to the macroeconomic challenges faced by our sector, which limited our growth throughout 2022, TargetOx revenue for the year declined by $14.4 million when compared against the full year 2021. reflecting the continued impact of generic competition for the brand. However, this shortfall was offset by increases of Cubrexa, Accutane, Amzik, and Zilxy, which represented 77% of our year-to-date revenue. During 2022, we achieved some noteworthy highlights. At the beginning of the year, we expanded our dermatologic footprint with the acquisition of Amzik and Xilxi from Vine Therapeutics. Amzik and Xilxi are two unique topical products that complement our currently marketed prescription-based products, including Cubrexa. We also executed settlement agreements with Patagas to enforce the patents covering Cubrexa, Amzik, and Xilxi, which will help solidify the exclusivity of Cubrexa, Amzik, and Xilxi and provide a clear pathway to grow the sales of these patented products for years to come. Additionally, we settled the Kebrexa patent infringement matter that we filed against Teva in December of 2022. In January 22, we established our ex-US presence upon receipt of notice from our exclusive out-licensing partner in Japan, Maruho Limited, that Rapafort Wipes 2.5%, the Japanese equivalent of Q-Brexa, was approved for the treatment of primary axillary hyperhidrosis in Japan. This approval triggered a net $2.5 million milestone payment to us pursuant to the terms of the asset purchase agreement between Journey and Dermira for Q-Brexa. On the product development front, As previously mentioned, we have achieved 100% enrollment in our Phase III DFD29 clinical trial as of January 2023, with top-line data readout expected in the second quarter of 2023 and an expected NDA filing in the second half of 2023. To reiterate, the market opportunity for DFD29 is immense. with an estimated 16 million people in the U.S. suffering from rosacea and as many as 415 million worldwide. The rosacea market had 3.6 million prescriptions in 2022 and 3.4 million prescriptions in 2021, according to Symphony data. The phase two trial results for DFD29 demonstrated nearly double the efficacy overall ratio, which is the current market leader and standard of care, with respect to both co-primary endpoints in the study, which were, first, the reduction in total inflammatory lesion count, and second, investigator global assessment success. Horatio had approximately $300 million in prescription sales in 2022, according to Symphony data. Once approved and launched, we believe DFD29 will be able to achieve net sales in excess of $100 million annually, which, to put in context, would exceed Journey's total revenue of $73.7 million in fiscal year 2022. With the anticipated continued growth and momentum of Cubrexa, Accutane, Amzeek, and Zilxy, the expected launch of our anti-itch product later this year, and ongoing efforts to maximize internal efficiencies, we expect our commercial operations to return to profitability. Through the combination of revenue growth and expense optimization, our goal for Journey is to be non-GAAP adjusted EBITDA positive for fiscal 2023. Our strategic focus on the continued expansion of our product portfolio through in-licensing, acquiring, and developing novel dermatology products and future product candidates combined with our industry-leading sales force, continues to be the cornerstone of our future growth. With that, I'll now turn the call over to Joe, who will review our financial results for the fourth quarter and full year.
spk08: Thank you, Claude. And hello, everyone. I will now review the full year and fourth quarter financial results for 2022. Our net revenues for the full year 2022 increased by $10.5 million, for 17 percent, $73.7 million, and $63.1 million for the full year of 2021. Increase is mainly due to revenue growth from our newly acquired products, Accutane and Cubrexo, which were acquired and launched in the first and second quarters of 2021, respectively, and incremental net revenue from Amzeek and Zilksey acquired in January 2022. Cubrexa, Accutane, and Zika and Zilxy now represent approximately 77% of our total net product revenues. Our net revenues for the fourth quarter of 2022 decreased by $1.6 million, or 9%, to $16 million from $17.5 million for the fourth quarter of 2021. The decrease is mainly related to generic competition for TargetOx, which began in the fourth quarter of 2021. Our gross profit margins for the full year and fourth quarter 2022 have increased by 38% and 3% respectively. The prior year included higher inventory acquisition step-up costs from CubeXA. In addition, during 2022, our contractual royalty obligations for CubeXA have decreased. A 10% royalty reduction to CubeXA occurred in May of 2022. It will decrease another 50% in May of 2023. Furthermore, as the mineral royalty to sun ended in December 2022, and our exoderm royalty to sun ends in the fourth quarter of 2023. These contractual royalty reductions will lead to further improvement in our margins going forward through 2023. Research and development expenses increased by $8.2 million to $10.9 million for the full year 2022, and $2.7 million for the full year 2021. RMD increased $2.3 million to $4.3 million for the fourth quarter of 2022, from $2 million for the fourth quarter of 2021. Increase for both periods is related to our continuing clinical trial expenses for the development of DFE 29. Looking now to our selling general and administrative expenses, SG&A increased $19.6 million, or 49%, to $59.5 million for the full year 2022, from $39.8 million for the full year 2021. Increase is mainly due to the expansion of our sales force and marketing expenses related to expanding our product portfolio. Additional headcount costs, including non-cash stock compensation, legal expenses associated with patent litigation, and compliance and other professional fees associated with being a public company that we did not incur as a privately held company prior to our IPO in November 2021. SG&A decreased by $1.1 million, or 7%, to $14 million for the fourth quarter, from $15.1 million for the fourth quarter of 2021. The decrease is mainly due to our expense optimization efforts, as we continue to improve our operational efficiencies post-IPO. while ensuring continued focus on the development and commercialization of VFD 29. We anticipate that our SG&A will decrease for 2023 as we continue to focus on expense optimization. Continuing to our net loss for the periods, net loss to common shareholders was $29.6 million, or $1.69 per share basic and diluted for the full year 2022, compared to a net loss to common shareholders of $44 million, or $4.32 per share basic and diluted for the full year of 2021. Net loss to common shareholders was $10.6 million, or $0.60 per share basic and diluted for the fourth quarter of 2022, compared to a net loss to common shareholders of $21.8 million, or $1.64 per share basic and diluted for the fourth quarter of 2021. Focusing now on our non-GAAP results, Our non-GAAP-adjusted EBITDA for the full year 2022 resulted in a net loss of $7.3 million, or 42 cents per share basic and diluted, versus a net loss of $10.9 million, or $1.07 per share basic and diluted for the full year of 2021. Our non-GAAP-adjusted EBITDA for the fourth quarter of 2022 reflects a net loss of $3 million, or 17 cents per share basic and diluted, versus a net loss of $1.7 million, with 13 cents per share basically diluted for the fourth quarter of 2021. We expect sequential improvement in our non-GAAP-adjusted EBITDA as we progress through 2023 and work towards our goal to be non-GAAP-adjusted EBITDA positive for fiscal year 2023. Moving to our cash, at December 31st, 2022, we had $32 million in cash and cash equivalents. Thank you very much, and I'll now turn it back to Clyde.
spk02: Thank you, Joe. Our strategy with our product portfolio expansion was designed to pivot during the lifecycle challenges like we have faced over this past year with TargetOx, which declined in revenue by $14.4 million in 2022. We remain optimistic about the future performance of our newly launched products heading into 2023. We are also excited about the full enrollment for both phase three clinical trials for DFD29 and the launch of another prescription product to add to our portfolio. With a strong financial foundation and continued momentum with our new products, we expect to achieve another year of product revenue growth in 2023. And our goal is to be non-gap adjusted EBITDA positive for fiscal year 2023 after backing certain non-recurring expenses, such as R&D, stock-based compensation expense, and other similar one-time expenses. Additionally, we anticipate sequential net revenue growth throughout 2023, beginning in our second quarter. Finally, we expect our SG&A expense for 2023 to be reduced by 5 to 7 million, targeting a range between 52 million to 54 million for the full fiscal year. I will now turn the call over to the operator for questions. Thank you.
spk06: Ladies and gentlemen, if you wish to ask a question on today's call, You will need to press the star button, then the number one on your telephone. If your question has been answered and you wish to withdraw your request, you may do so by pressing star, then two. If you're using a speakerphone, please pick up your handset before entering your request and speaking on the call. One moment, please, for the first question. Our first question will come from Brandon Foulkes with Cancer Fitzgerald. You may now go ahead. Hi.
spk07: Thanks for taking my questions, and congratulations on all the progress in 2022. Maybe just two from me. Maybe just starting on the commercial business, you've seen quite a big uptake in Accutane prescriptions in 2023. So just any color in terms of what you're doing different there or what's resonating or what's driving that strength And then maybe on DFD 29, in terms of looking at the differentiating factors of this product, obviously there's efficacy that, you know, if it holds, it's obviously going to be a very strong differentiating factor. But any other differentiating factors you think we should pay attention to when we look at the data and we think about the commercial landscape? Thank you very much.
spk02: Okay, great. Thank you, Brandon, and good to hear your voice. The first question regarding Accutane. Yes, absolutely. 2023, we have gotten off to a very strong start, and prescription trends by Symphony Data are indicating anywhere in the ranges of 19,000 plus to 20,000 plus per month in the first two months here. So we like where we are headed. I think our sales force, our marketing efforts are really making some headway. And our aggressiveness in this area have started to pay dividends. So we were able to, for the most part in all of 2022, hold our market share anywhere between about 11.1% to 12 plus percent. And we believe that there is more ample opportunity for that market share to grow in 2023 here. It is one of our key focuses. Our flagship brand is Qbrexa, followed secondly to Accutane. So our commercial sales team is focused on it in terms of their priorities. And so far, I'd say we're in stride with Accutane. In terms of DFD29, to your second question, So there's a couple key things I'd like to mention. First, you know, the co-primary endpoints are almost or are exactly the way Oratia had done their trials when they got approval. So we decided to mimic that as well as not only going head-to-head against placebo, but also doing the same thing with Oratia. What we want to do is have a robust package insert allow our commercial and marketing team to really take advantage, as you said, about the efficacy. The additional part of this is, for myself, is the fact that in terms of payers, it's not enough to go against just placebo these days. So going head-to-head against what is considered the standard of care and the Phase II results showing double that efficacy in both co-primary endpoints really will help with, I think, the payer contracts and where we end up negotiating. I'd like to also pass the same question on to Dr. Sidgiddi to give some more differentiation surrounding DFD 29.
spk05: Thanks, Claude, and thanks, Ben, for that question. The significant differentiator, as you said, Brandon, is going to be the efficacy. And as Claude mentioned, the two co-primary endpoints of lesion count, as well as IgA treatment success, those are going to be significant differentiators. We might also look at a couple of additional secondary endpoints, like the impact on erythema, the impact on quality of life, those are going to be additional handles that we might get if we get good results. We do expect, based on the phase two study results, that there is going to be significant superiority on multiple endpoints.
spk07: Great. Thanks for that question. It does. And thank you very much to both of you for the answers. Very helpful. Thank you.
spk06: Our next question will come from Scott Henry with Roth Capital. You may now go ahead.
spk03: Thank you, and good afternoon. I have a couple questions, but I'll start on the big picture. Claude, you know, targeting EBITDA positive, albeit adjusted results in 2023, is an admirable goal. I mean, you're starting from minus $4 million in Q3, minus $3 million in Q2. It sounds like you just don't want to exit it, but you want to have the whole year break even. I commend you for that. But now I want to try to figure out a little better of how we're going to get there. I think you said it sounds like $5 to $7 million in SG&A. That gets you almost all the way there. But then, you know, the question are, you know, within that five to seven million, do you, you know, will any of that be sales and marketing driven? Will that present any challenges to have the same share of voice out there in 2023 that you had in 2022?
spk02: Sure. Yeah. Thank you, Scott, for that question. It is a goal of ours, and we are highly focused on achieving that. I think a number of ways, as you mentioned, partly due to the commercial structure that we have. We have taken steps in early January, and we have reduced the size of our sales force. And what we did when we were aggressive in building our portfolio, we had doubled the size of our sales force. If you go back in time in some of our other conversations, we had 42 individuals. We doubled that to another 42 to a total of 84. As we peaked at that point and as the sales trends continued and then really the uh difficulty in the in the target ox with the generic competition we had to make some adjustments to that so we've taken those necessary steps with the field sales force but your your question was also targeted you know are we going to lose any geography and coverage reach and frequency that type of thing and i i tell you that we're we're not so what we did was we actually had two individuals in each territory when we were at our peak of 84. We've reduced that now, but we still have all the geographic coverage that we had in the past, albeit some territories will only have one individual versus two. And the way we decided to come to that configuration is all about profitability. And we look at profitability by territory not just on a quarterly basis, but by a monthly basis. And we were able to determine the best configuration and we feel that what we have right now will really suffice and still get us to the goals that we want to achieve. So you would expect with the lower numbers to possibly have lower expectations, but we still have the same expectations as before. And again, all the geography is still being covered. Now, every representative doesn't have the same portfolio to promote and educate and answer questions to our customers. So we do that very custom-styled in each territory. And then in the second part, really, optimization and efficiencies, we're taking other steps to reduce that, not just by the Salesforce, but by, like you mentioned, marketing and bringing some things that we've used outside vendors for and bringing those internally.
spk03: Okay, great. I look forward to that progress. Shifting to the product items, Accutane scripts are great, as the previous question hit on. So we should expect that to grow. Can you talk a little bit, you know, CubeRex is a big, the flagship product, I believe you referred to it as. How should we think about that as a growth asset? Is that a, you know, should we be thinking about that as a 5% to 10% grower? Or, you know, ideally, I think you'd like it to be higher than that. But how should we think about it in 2023?
spk02: Yeah, I'll start out by saying this. You know, we had a major success last year when we settled the patent infringement cases with Patagus, and Qbrexa was part of that. And I'm glad to say we've got a long road of exclusivity with this brand that takes us all the way out into 2030. And our marketing and commercial teams, I think, have a really good strategy to continue educating and bringing awareness to and hopefully that means increasing our demand for Q-brexa out there. In 2022, Scott, we achieved an all-time record for this particular brand, Q-brexa, and we hit well over 116,000 prescriptions. It launched in 2018, and we just hit that record. So I think we've got some momentum behind us. Specifically, What percent of gain that we're going to have with each product, we're not necessarily giving guidance on that, but I can tell you I have high expectations. It's number one out of the bag with a significant majority of our sales force. We have great marketing strategies to continue to be able to get the product as simple and as easy as to the patients once the doctor has decided to prescribe that for their primary axillary hyperhidrosis. So I think we've got a number of key items here that are going to really help bring some growth into this brand.
spk03: Okay. And when would you expect the anti-itch product to launch? Any clarity there?
spk02: Yeah. I'd love to give you an exact date and month. I'm not going to be able to do that. Right now, it's positioned for the second half of 2023. We are working very closely with our manufacturer, and we have some good guidance from them, but that has been pushed out several times before. They've given us guidance again, and it's going to be in the second half of 2023.
spk03: Okay, great. Now, shifting gears, and I'll wrap up pretty quick here, but COGS was pretty high in Q4. Anything going on there? When should we expect that to kind of normalize with higher margins?
spk02: Sure. Joe, would you like to take that one, please?
spk08: Sure, sure. Our COGS in the fourth quarter included some freight, some additional validation and testing costs that we have through COGS. That was for Amzeek and Ziltsi for the most part. 2023 will not have those costs, at least not as high. So with the reduction in the royalties and the reduction in some of those expenses, we expect our margins to be around the 60% range. Okay, great.
spk03: Thank you. And then final question just on the pipeline product DVD, I think 124. Hopefully I got those letters right. Enrollment was complete, let's say, mid-January. If I'm trying to think about when the data should be, is it follow-up in that trial? Remind me, is it a 12-week follow-up? And then we should maybe think about a month to slice and dice the data. Is that the right way to think about the timing of that data?
spk02: Yeah, it's DFD 29, and Dr. Sagitti will give you the specifics on that.
spk05: Hey, Scott. Thanks for that question. DFD29, as we mentioned in our press release, the last subject first visit, that is the last subject enrolled, was early January. And there is a treatment duration of 16 weeks. That is, each subject will be treated for 16 weeks with this product. And then there is, as you said, a four to six weeks duration for the slicing the data and analyzing. So that's what makes it towards the end of the first half of 2023, somewhere around June 2023.
spk03: Perfect. Thank you for the clarity there, and thank you for taking the questions. Thanks, Scott.
spk06: Again, if you have a question, please press star then 1. Our next question will come from Kelpit Patel with 3 Riley Securities. You may now go ahead.
spk04: Good afternoon. This is Andy Fleischer on for Kelpit. Thank you for taking questions. It looks like some of the method of use patents for Aurasia are set to expire starting next year. In anticipation of potential generic introductions for Aurasia, how should we think about the potential market opportunity for DFB29? Specifically, you guided the peak sales of over $100 million. Does this figure factor in the possibility of generic cannibalization, and does it assume that DFD29 demonstrates improved efficacy over Aurasia?
spk02: Yeah. Hi, Andy. Yeah, it's Claude here. Thanks for the question. Yeah, the final, you know, the patent expiry on Aurasia is on December 2025 is the way we're looking at it. Again, this product is a Galderma asset, and they actually have had an authorized generic out into the marketplace now for several years. So that mix has been out there, and it's now more skewed to the generic. Again, roughly it's about 60% on the generic and 40% on the brand. And I think you really honed in on exactly it. The study results for DFD 29 in the Phase 2 are superb. Again, almost doubling the efficacy of the co-primary endpoints. If we are able to achieve that type of level and get that approval, we believe that that is going to be very meaningful. where you can actually say that this product has this much better efficacy and very comparable safety, for example, I think that goes a long way. And that's why we believe, again, when we've discussed this with our KOLs and other consultants, the early adoption for DFD is going to be quite considerable. So we're expecting a very quick uptake. And that's how we see us getting to those numbers. So brand or generic, if you have an asset that has tremendous results, you're going to have a very big home run in the field of dermatology. Any time you can get close to that $100 million mark, that's considered a grand slam, again, in these small molecules.
spk04: That's helpful. Thank you. And then maybe one follow-up on the advocacy piece of it. I guess what feedback are you hearing specifically from those KOLs and the physician community that gives you confidence that they would prescribe DFD29 over Oratia if the advocacy holds up in a pivotal study?
spk02: Sure. You know, what we did simply is we've shared during our due diligence, we have shared all the Phase II data and we've asked them to analyze it, and we've given them the messages that we believe we would be able to do once we have an approved label, and the feedback was exactly that. Make sure you have a product that's not just going to be approved going against a placebo. You have to go against the market leader, and that's Horatio. So that's what the phase two included, fortunately for us, and that's what we are counting on here in the Phase III study. And secondly, when they looked at all the various adverse events, very comparable. So they're already familiar with Oratia. They've been relatively satisfied with its efficacy. Now we're going to be introducing a new indicated product for Rosacea specifically that hopefully is getting close to doubling the efficacy. You know, the question is, why wouldn't they convert over quickly to this brand? And that's what we heard time and time again. And, you know, there's minocycline doctors, there's doxycycline doctors, and there's different classes, right? And a lot of these doctors that we did speak to were the doxycycline, and we were very positive and very pleased with what we were the feedback that we received. And that really was a key factor in us moving forward in licensing and acquiring this asset.
spk04: I appreciate the additional color, and we're looking forward to the results of that study here in the second quarter. Excellent. Thank you, Andy.
spk06: This concludes our question and answer session. I'd like to turn the call back over to Claude for any closing remarks.
spk02: Sure. I just want to thank everyone for their participating in today's conference call and their interest in Journey Medical. We look forward to sharing our ongoing progress when we report the first quarter results in May. Thanks, and have a good day, everyone.
spk06: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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