Journey Medical Corp Q4 FY2022 Earnings Call

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. 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 Blazei of CORE IR, the company's Investor Relations firm. Please go ahead, sir.

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 Maraoui, Co-Founder, President and Chief Executive Officer; Joseph Benesch, Interim Chief Financial Officer; Ramsey Alloush, General Counsel; and Dr. Srini Sidgiddi, 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 refer to 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, 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 Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical.

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 DFD-29. We have achieved 100% enrollment in the clinical trials as of the beginning of January 2023, with an expected topline 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 DFD-29 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, Targadox 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 QBREXZA, ACCUTANE, AMZEEQ, and ZILXI, 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 AMZEEQ and ZILXI from VYNE Therapeutics. AMZEEQ and ZILXI are two unique topical products that complement our currently marketed prescription-based products, including QBREXZA. We also executed settlement agreements with Padagis to enforce the patents covering QBREXZA, AMZEEQ, and ZILXI, which will help solidify the exclusivity of QBREXZA, AMZEEQ, and ZILXI and provide a clear pathway to grow the sales of these patented products for years to come. Additionally, we settled the QBREXZA patent infringement matter that we filed against Teva in December of 2022. In January '22, we established our ex-U.S. presence upon receipt of notice from our exclusive out-licensing partner in Japan, Maruho Limited, that Rapifort Wipes 2.5%, the Japanese equivalent of QBREXZA 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 QBREXZA. On the product development front, as previously mentioned, we have achieved 100% enrollment in our Phase III DFD-29 clinical trial as of January 2023. With topline 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 DFD-29 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 II trial results for DFD-29 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. Oracea had approximately $300 million in prescription sales in 2022 according to Symphony data. Once approved and launched, we believe DFD-29 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 QBREXZA, ACCUTANE, AMZEEQ, and ZILXI, 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.

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 or 17% to $73.7 million from $63.1 million for the full year 2021. The increase is mainly due to revenue growth from our newly acquired products, ACCUTANE and QBREXZA, which were acquired and launched in the first and second quarters of 2021, respectively, and incremental net revenue from AMZEEQ and ZILXI acquired in January 2022. QBREXZA, ACCUTANE, AMZEEQ, and ZILXI 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 Targadox, which began in the fourth quarter of 2021. Our gross profit margins for the full year and fourth quarter of 2022 have increased by 38% and 3%, respectively. The prior year included higher inventory acquisition step-up costs from QBREXZA. In addition, during 2022, our contractual royalty obligations for QBREXZA have decreased. A 10% royalty reduction for QBREXZA occurred in May of 2022 and will decrease another 50% in May of 2023. Furthermore, XIMINO royalty to Sun ended in December 2022 and our EXELDERM 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 from $2.7 million for the full year 2021. R&D increased $2.3 million to $4.3 million for the fourth quarter of 2022 from $2 million for the fourth quarter of 2021. The increase for both periods is related to our continuing clinical trial expenses for the development of DFD-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. The increase is mainly due to the expansion of our sales force and marketing expenses related to expanding our product portfolio, additional headcount costs, including noncash 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 DFD-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 $0.42 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 $0.17 per share basic and diluted versus a net loss of $1.7 million or $0.13 per share basic and 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 31, 2022, we had $32 million in cash and cash equivalents. Thank you very much, and I'll now turn it back to Claude.

Thank you, Joe. Our strategy with our product portfolio expansion was designed to pivot during the life cycle challenges like we have faced over this past year with Targadox, 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 III clinical trials for DFD-29 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-GAAP adjusted EBITDA positive for fiscal year 2023 after backing certain nonrecurring 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 million 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.

Our first question will come from Brandon Folkes with Cantor Fitzgerald.

Congratulations on all the progress in 2022. Maybe just two for me. Maybe just starting on the commercial business. There seems to be 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 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 you think about the commercial landscape?

Thank you, Brandon, it's great to hear from you. Regarding ACCUTANE, we've started 2023 very strongly, with prescription trends showing over 19,000 to 20,000 per month in the initial two months. We're pleased with our progress; our sales and marketing efforts have been effective, and our focus in this area is yielding results. In 2022, we maintained our market share around 11.1% to over 12%, and we see further opportunities for growth in 2023. ACCUTANE is a key priority for our commercial sales team, along with our flagship brand, QBREXZA. As for DFD-29, I want to note that the co-primary endpoints closely align with those used in the Oracea trials for approval. We opted to follow this path, engaging not only against placebo but also in direct comparison to Oracea. Our aim is to produce a strong package insert that our commercial team can leverage effectively. It's crucial in today's market to compete against established standards of care, and the Phase II results indicating double the efficacy in both co-primary endpoints will be beneficial for our negotiations with payers. I'd like to invite Dr. Sidgiddi to provide additional insights on DFD-29's differentiating factors.

Thanks, Claude, and thanks, Brandon, 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 Eridama and 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 II study results, that there is going to be significant superiority on multiple endpoints.

Our next question will come from Scott Henry with Roth Capital.

I have a couple of questions, but I'll start with the big picture. Claude, aiming for EBITDA positivity, even in adjusted results for 2023, is an admirable goal. You're beginning from minus $4 million in Q3 and minus $3 million in Q2. It seems like you're not just looking to exit but aiming for the whole year. I commend you for targeting breakeven. Now, I want to understand better how we will achieve that. I believe you mentioned that $5 million to $7 million in SG&A nearly gets us there. However, within that $5 million to $7 million, will any of it be driven by sales and marketing? Could that present challenges in maintaining the same share of voice in 2023 as you had in 2022?

Sure. Yes. 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. 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 and 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 difficulty in the Targadox 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 question was also targeted, are we going to lose any geography and coverage, reach and frequency, that type of thing. And I’d tell you that we're not. 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 that some territories will only have one individual versus two, and the way we decided to come to that configuration is all about profitability. We look at profitability by territory not just on a quarterly basis but on a monthly basis, and we were able to determine the best configuration, and we feel that what we have right now will 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 for 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 sales force, but like you mentioned, marketing and bringing some things that we've used outside vendors for and bringing those internally.

I look forward to that progress. Regarding the product items, ACCUTANE scripts are performing well, as noted in the previous question, so we should expect growth there. Can you provide some insight on QBREXZA, which I believe you referred to as your flagship product? How should we view it as a growth asset? Should we expect it to grow by 5% to 10%, or would you ideally like it to exceed that in 2023?

Yes. I'll start out by saying this. We had a major success last year when we settled the patent infringement cases with Padagis, and QBREXZA was part of that. 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. Our marketing and commercial teams, I think, have a really good strategy to continue educating and bringing awareness and hopefully that means increasing our demand for QBREXZA out there. In 2022, Scott, we achieved an all-time record for this particular brand, QBREXZA, and we hit well over 116,000 prescriptions. It launched in 2018, and we just hit that record. I think we've got some momentum behind us. Specifically, what percent gain we are 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 #1 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 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.

Okay. And when would you expect the anti-itch product to launch? Any clarity there?

Yes. 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.

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?

Sure. Joe, would you like to take that one, please?

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 AMZEEQ and ZILXI for the most part. 2023 will not have those costs, at least not as high. So with the reduction in the royalties and reduction in some of those expenses, we expect our margins to be around the 60% range, give or take.

And then final question just on the pipeline product, DFD-29. I think the enrollment was complete, let's say, mid-January. If I'm trying to think about when the data should be is a 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?

Yes, it's DFD-29, and Dr. Sidgiddi will give you the specifics on that.

Scott, thanks for that question. DFD-29, 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. Each subject will be treated for 16 weeks with this product. And then there is, as you said, a 4 to 6 weeks duration for analyzing the data. So that's what makes it towards the end of the first half of 2022, somewhere around June 2023.

Our next question will come from Kalpit Patel with B. Riley Securities.

This is Andy Fleszar on for Kalpit. It looks like some of the method of use patents for Oracea are set to expire starting next year. In anticipation of potential generic introductions for Oracea, how should we think about the potential market opportunity for DFD-29. 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 DFD-29 demonstrates improved efficacy over Oracea?

Thank you for your question, Andy. The patent for Oracea is set to expire in December 2025. This product is owned by Galderma, which has had an authorized generic on the market for several years, leading to a current distribution of about 60% for the generic and 40% for the brand. You've pointed out the key aspects well. The Phase II study results for DFD-29 are very impressive, nearly doubling the effectiveness of the co-primary endpoints. If we can achieve such results and secure approval, we believe this will be significant as it would show that this product has much better efficacy while maintaining comparable safety. This finding is promising, and discussions with our key opinion leaders and consultants indicate that early adoption for DFD-29 is likely to be substantial. We anticipate a swift uptake, which aligns with our projected figures. Whether it's brand or generic, a product demonstrating outstanding results can make a significant impact in dermatology. Reaching close to the $100 million threshold is regarded as a major success for small molecules.

That's helpful. And then maybe one follow-up on the efficacy 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 DFD-29 over Oracea if the efficacy holds up in the pivotal study?

Sure. What we did is share all the Phase II data during our due diligence and asked them to analyze it. We provided messages regarding what we believe we could achieve once we have an approved label. The feedback was to ensure we have a product that will not only be approved against a placebo but also compete with the market leader, which is Oracea. Fortunately, the Phase II included this aspect, and we are counting on it for the Phase III study. Additionally, when examining the various adverse events, the results were very comparable. They are already familiar with Oracea and have been relatively satisfied with its efficacy. Now, we are introducing a new product indicated specifically for rosacea, which we hope will nearly double the efficacy. The question is, why wouldn’t they quickly switch to this new brand? This was a consistent sentiment we heard. We spoke with many doctors who typically prescribe doxycycline and received very positive feedback. This was a key factor in our decision to move forward with licensing and acquiring this asset.

This concludes our question-and-answer session. I would like to turn the conference back over to Claude for any closing remarks.

Sure. I just want to thank everyone for their participation 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.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.