Journey Medical Corporation

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Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. 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 Jacqueline Jaffe, the company's Senior Director of Corporate Operations. Please go ahead, Jacqueline.

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team are Claude Morawi, Co-Founder, President, and Chief Executive Officer, Joseph Banesh, Interim Chief Financial Officer, Dr. Srini Sidghetti, Vice President of Research and Development, and Ramzi Alush, General Counsel and Corporate Secretary, who will be joining for the Q&A portion of the call. 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 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 report 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 content of this call contains time-sensitive information that is accurate only as of today, November 7, 2023. Except as required by law, Journey Medical disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occur after this call. It is now my pleasure to turn the call over to Claude Morawi, Co-Founder, President, and Chief Executive Officer of Journey Medical.

Thanks, Jacqueline. Good afternoon, and thanks to everyone for joining our third quarter 2023 conference call and corporate update. Let me begin by saying that Q3 2023 continues to be a very positive and evolving time for Journey Medical. Our focus during our second year as a public company is to achieve profitability from our commercial operations. To achieve this, we've been working with three critical factors. The first is driving net revenue for our four core brands, Cubrexa, Accutane, Amzeek, and Zulci. The second is optimizing and reducing our SG&A. And the third is building out our portfolio through licensing and acquisition while advancing our DFD29 product candidate for Rosacea. In the third quarter of 2023, our total net revenues, which included the MARUHO Outlicensing upfront payment, was $34.5 million, which is an increase of 101% from $17.2 million in the second quarter, and an increase of 114% from $16.1 million in the third quarter of 2022. As evidenced by our most recent transaction, we believe that CubeRexa, as well as our patented products, including DFD29, are extremely attractive near-term opportunities for those companies looking to exclusively in-license our products in other countries. We previously gave guidance in March of this year that we expected our SG&A expense to be reduced by $12 million for 2023 compared to 2022. Through our financially disciplined approach, we are raising our guidance to reduce SG&A expense by approximately $17 million for 2023 compared to 2022. Regarding our clinical development asset that is being evaluated for the treatment of rosacea, DFD29, we are encouraged by the recent positive top-line results demonstrating statistically superior efficacy over rosacea and placebo in the two Phase III clinical trials. We remain on track to submit a new drug application to the FDA for DFD29 around the end of this year. We believe that the opportunity to enhance patient care for those who suffer from rosacea with a potentially best-in-class therapy will be appealing to both patients as well as medical providers who treat this type of condition. In terms of prescription market size, There were approximately 4 million prescriptions written for rosacea in 2022, according to Symphony Health prescription data. If approved by the FDA, we believe that DFD29 has annual peak net sales potential in excess of $300 million globally. With these clinically meaningful outcomes, DFD29 has the potential to become the new treatment paradigm for the millions of patients suffering from rosacea as well as the lowest dose oral minocycline on the market. We believe that the potential approval and commercial launch of DFD29 will be a transformational event for both Journey and the broader dermatology community. At this point, I would like to turn the call over to Dr. Srini Sigiddi to discuss our DFD29 clinical program in greater detail.

Thank you, Claude. And hello, everyone. I would like to begin by reviewing the highlights from the phase three studies for DFD29. I'd also like to refer investors to the investor presentation on our website, which contains the slides supporting my remarks here in more detail. Journey Medical in collaboration with Dr. Reddy's has recently conducted and completed two pivotal phase three studies for DFT29. Both studies had the following key design elements. Each study enrolled approximately 320 patients with moderate to severe rosacea in a 3 is to 3 is to 2 randomization to DFT29, Aurasia, or placebo. The first study, MVOR1, enrolled patients solely in the US, while the second study, MVOR2, enrolled patients in a ratio of approximately 70 is to 30 in the US and Germany. All subjects had moderate to severe rosacea 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 two co-primary endpoints. The first, proportion of subjects with IgA treatment success. The second, reduction in total inflammatory lesion count. In addition, this study had five secondary endpoints that were adjusted for multiplicity, meaning that there is a possibility of being included in the label upon FDA approval if the results are statistically superior to placebo. The results for the co-primary and all five secondary endpoints demonstrated that DFT29 was statistically significantly superior to both placebo and Aurasia with 16 weeks treatment duration. The proportion of subjects that showed IgA treatment success was 65% for DFT29, 46.1% for Aurasia, and 31.2% for placebo in MVOR1. The p-value for the difference between DFT29 and Aurasia was 0.014, while it was less than 0.001 against placebo. In MVOR2, the proportion of subjects that showed IgA treatment success was 60.1% for DFT29 31.4% for Aurasia and 26.8% for placebo. The p-values were less than 0.001 for DFT29 against both Aurasia and placebo. In MVOR1, the reduction in total inflammatory lesion count was minus 21.3 for DFT29, minus 15.9 for Aurasia, and minus 12.2 for placebo. The p-values were less than 0.001 for DFT29 against both Aurasia and placebo. In MVOR2, the reduction in total inflammatory lesion count was minus 18.4 for DFT29, minus 14.9 for Aurasia, and minus 11.1 for placebo. The p-values were less than 0.001 for DFT29 against both Auresia and placebo. As can be seen from the data, DFT29 consistently outperformed both Auresia and placebo on the two co-primary endpoints in both studies. One of the important secondary endpoints was erythema reduction because erythema, that is redness, happens to be one of the important signs relevant to both providers and their patients. The proportion of subjects that showed CEA success, that is erythema success, was 31.7% for DFT29 and 13.8% for placebo in MVOR1. The p-value for the difference between DFT29 and placebo was 0.006. In MVOR2, The proportion of subjects that showed CEA success was 24.5% for DFT29 and 12% for placebo. The p-value was 0.023 for the difference between DFT29 and placebo. If approved, the significant impact on erythema reduction is expected to result in a unique differentiator on the label and DFT29 is likely to be the first oral therapy with an indication for the treatment of inflammatory lesions and erythema of rosacea, while most other therapies approved for rosacea have either treatment of inflammatory lesions or treatment of erythema on their labels, but not both. DFT29 has also demonstrated statistically significant improvement in quality of life against placebo with regards to both DLQI and ROSACOL, two widely accepted tools for quality of life assessment in dermatology. We are encouraged by DFT29's safety profile that was demonstrated in both of the studies with the adverse event rates being close to placebo. These results indicate the possibility of TFT29 being the new standard of care in rosacea and also being the best in class therapy with head to head superiority over the current standard of care. Additionally, it is likely to be perceived as a potentially safer minocycline compared to other oral minocycline therapies because of the low and fixed daily dose. We anticipate DFT29 to capture significant market share upon its launch based on the significant differentiators demonstrated in the phase three studies. The most recent update on DFT29 is from October 2023, where we had a productive pre-NDA meeting with the FDA for DFT29. We expect to provide and update following receipt of the FDA meeting minutes. Thank you very much. And now I'll hand it to Joe to discuss our third quarter financial results in greater detail.

Thank you, Dr. Siddighi. And hello, everyone. I will now review the third quarter financial results for 2023. Total net revenues for the third quarter were $34.5 million, a 101% increase from $17.2 million in the second quarter, and an $18.4 million or 114% increase from the prior year quarter due to our most recent out licensing agreement with Meruho. Net product sales were $15.3 million for the third quarter. a slight decrease of $800,000 from $16 million in the third quarter of 2022. The decrease is primarily due to lower net revenue from Zimino, resulting from lower unit volumes due to the winding down of the product during the third quarter. We discontinued selling Zimino on September 29, 2023. The decrease was partially offset by an increase in net product revenues from Accutane, Amzeek, and Ziltsy due to our continued sales and marketing emphasis on these products. Our four core products, Cubrexa, Accutane, Amzeek, and Ziltsy, all acquired and launched since 2022, represent approximately 90%, or $13.8 million, of our total net product revenue for the third quarter of 2023. Cost of goods sold decreased by $800,000, or 11%. to $6.4 million for the third quarter of 2023 and $7.2 million for the third quarter of 2022. The decrease is substantially due to the contractual royalty percentage reduction on QBREX and net sales from period to period. Research and development expenses decreased by $600,000 compared to the prior year quarter due to lower DFD 29 expenses as the clinical development activities continue to wind down. SG&A expenses decreased by $7 million, or 45%, from the prior year quarter. The decrease is mainly due to our expense reduction efforts, primarily in sales and marketing. As we have discussed in prior quarter calls, during the last quarter of 2022, we implemented a cost reduction initiative designed to improve operational efficiencies, optimize expenses, and reduce overall costs. As demonstrated by SG&A expense in Q3, our efforts have proven to be effective. The impact of these cost reduction initiatives is expected to result in a reduction of approximately $17 million of annual SG&A expenses, surpassing our earlier target of $12 million. The company recorded gap net income of $16.8 million, or $0.91 per share basic and $0.80 per share diluted for the third quarter of 2023, compared to a gap net loss of $8.4 million, or $0.46 per share basic and diluted for the second quarter of 2023. and a GAAP net loss of $10.1 million or 57 cents per share basic and diluted in the third quarter of 2022. As you can see, the company has made significant strides and continues to improve its operating performance. The company's non-GAAP adjusted EBITDA for the third quarter of 2023 resulted in income of $20.8 million or $1.13 per share basic and $0.99 per share diluted compared to an adjusted EBITDA net loss of $600,000 or $0.04 per share basically diluted for the second quarter of 2023 and an adjusted EBITDA net loss of $4 million or $0.23 per share basically diluted for the third quarter of 2022. We expect that the company will be non-GAAP adjusted EBITDA positive for the full year 2023. At September 30, 2023, we had $24.8 million in cash and cash equivalents compared to $32 million of cash and cash equivalents at December 31, 2022. As a result of our recent payoff of the EWB debt facility, the company no longer has any debt obligations. Thank you very much. And now we'll turn it back to Claude.

Thank you, Joe. The positive momentum is evident and is expected to continue into the final quarter of 2023. We believe that this momentum is further reflected by our stock price performance, which as of yesterday is up approximately 70% year to date. I'd like to close the call by reminding everyone that November is Hyperhidrosis Awareness Month. A key initiative at Journey is to continue to build disease state awareness, education, and the treatment option that Q-Brexa offers for patients suffering from this condition. Thank you and have a good day. I will now turn the call back over to the operator.

Thank you. We will now begin the question and answer session. To ask a question, you may press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Scott Henry with Roth Capital. Please go ahead.

Thank you. Good afternoon and congratulations. A lot of progress on the income statement. A lot of progress in the pipeline. So great job there. A couple questions. When we think about Q4 to Q3, just trying to get a sense of how we should think about that, both from a revenue standpoint, And as well, that SG&A, do you think you can cut it? It was 8.6 in Q3. Is there more? Is it going lower than that, or are we kind of at a steady state at this point?

Hey, Scott. Good to hear your voice. I'll take part of this question. In terms of Q4 and how that's going to reflect comparing it to Q3 here, You know, we're one month into the fourth and final quarter of the year. We've got good momentum. The prescriptions look solid, and I would expect a very strong quarter similar to what you see in Q3 so far. And then in terms of our SG&A efforts and operating efficiencies, I'm going to have Joe jump in here and give you his take.

Sure. Thanks, Claude. And how are you doing, Scott? So from a CNA standpoint, Scott, we should be pretty even with the third quarter. There's a chance we could be a little bit better, but from an expectations point, I would definitely keep it at, you know, even with the third quarter. Okay, great. Our guidance sticks, you know, with the $17 million.

Okay, fantastic. And then any color on Accutane and Cubrexa? I know you mentioned if you combine them all together, but any surprises there? I mean, I would have guessed they looked kind of similar to last year, but just any color on those two?

Yeah, in terms of Accutane, I think we're very pleased with how the product is performing. I think from a sales and marketing end, the message is getting out there. I think more and more patients and physicians are turning to the brand Accutane. So we like where we are. Right now we have approximately a 14.5% market share. So in no ways have we come close to hitting our ceiling. And we've got a lot of emphasis with the sales force right now on that particular brand. So in terms of Qbrexa, you know, there is seasonality for this brand. We're heading into the winter right now. So there can be some offsets with that. But generally, I would anticipate a very similar solid quarter in Q4 as you've seen in Q3 here with Qbrexa.

Okay, great. Final question just on DFD29. The Rosacea data was pretty compelling. Pretty big potential product, particularly relative to the size of the company Journey is today, although a lot more today than three months ago. The question is, do you get any incoming calls on that asset? I mean, is it possible if someone made you an offer you couldn't refuse that you would look at partnering that in perhaps bigger hands, or do you even consider that? Thank you.

Sure. Yeah, Scott, great question. You know, with the results that came out, the Phase 3 results that came out in early July, it certainly has caught a lot of attention from the from the industry as well as a lot of interested parties and potentially licensing the asset from us outside of the country here in the U.S. In terms of, you know, would we ever entertain any sort of potential offer for the asset, you know, I think it's all in the in what the offers look like. We're always open. We're very opportunistic when it comes to business development, and we've always got an open ear. But right now, we are really focused on continuing to execute and make sure we have all the launch plans ready to really hit the door running once we get the approval, hopefully, in the later half of 2024. So, all hands are on deck, and that's as much as I could say. Okay.

Great. Thank you for taking the questions.

Our next question comes from Andy. Please go ahead.

Hey, good afternoon. Thank you for taking questions. A few from us, starting with DFC-29, what market research may be emerging ahead of the NDA and the potential launch there? And have you sampled prescribers to get a better understanding of the drug's potential positioning in the market?

Sure, Andy. Thanks for the question. Yeah, previously we've already conducted some market research, specifically with payers, to really examine drug the price sensitivity, for example, and potential contracting requirements that would be needed. Now we want to revalidate that, and we've got additional research that's being conducted as we speak. So, I mean, some of the areas are in terms of looking at a ratio where it's contracted, potential generics to a ratio, and what that means to the marketplace. as well as considerations of the perceptions of our providers. So, you know, how does DFD29, this modified minocycline release once a day that will have hopefully a very unique indication for anti-inflammatory and erythema associated to rosacea, you know, and we want to get aided and unaided, you know, qualifications from our customers. So we want to look at all sorts of factors. And like I said, we really want to understand and validate our adoption and our peak demand for this particular product, and then how long it will take for that peak to come. So we have great assumptions. We've already validated a lot of this with previous market research. But now with the studies conducted and complete, And now we're doing additional research.

Okay, great. We'll look forward to some of the results there. And then from your prepared remarks, it sounds like erythema may be included in the label. Can you elaborate on that at all?

Sure. I'm going to have Dr. Srinivas talk about that a little bit.

Thanks, Claude. And thanks, Andy, for that question. That's a very good question. The thing that I would like to say about erythema is that erythema happens to be one of the secondary endpoints that we had on the phase three studies. And the secondary endpoints were adjusted for multiplicity, which means that if there is statistical superiority to placebo, there is a very high chance of that endpoint ending up on the label. So since it was a multiplicity adjusted secondary endpoint and it was agreed with the FDA in terms of where it would be placed in the hierarchy, we believe that we have a good chance of getting that on the label.

Excellent. That's very helpful. And now switching gears, one final question for me on Accutane. It sounds like you're having continued growth in market share at 14.5%. But I know that we had a bit of a slowdown in the iso-tretinoin market overall last year. Have things kind of returned to the expected long-term growth rate there and any additional color you can provide on the overall market?

Sure. Yeah, Andy, just to give you some market background on the iso-tretinoin market in 2021, and that's all iso-tretinoins included. there was about 2,075,000 prescriptions. And in 2022, about the same amount. And now in 2023, through the first three quarters, we're at about 1.5 and change. So it looks like it is going to be close to that 2 million prescription market. There was a touch of a slowdown, but I think we're starting to see that ramp back up. So it's holding very strongly. I think we saw some good single digits year over year. That's just backed off a bit, but it's very nominal.

Great. Thanks for the additional color, and thank you for taking the questions.

Sure. Absolutely.

This concludes our question and answer session, as well as our call for today. Thank you for attending today's presentation. You may now disconnect.