Ladies and Gentleman, thank you for standing by. Good afternoon and welcome to Journey Medical Second Quarter 2023 Financial Results and Corporate Update conference call. At this time all participants are in listen-only mode. [Operator Instructions]. I would like now to turn the call over to Mr.

Matt Blazei of CoreIR, the company's investor relations firm. Please go ahead, sir..

Good afternoon and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team are Claude Maraoui, Co-Founder, President & Chief Executive Officer; Joe Benesch, Interim Chief Financial Officer; Dr.

Srini Sidgiddi, Vice President of Research and Development; and joining us to the Q&A session will be Dr. Neal Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research.

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 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 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, it's most directly comparable GAAP financial measure, please 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, August 8, 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 second quarter 2023 conference call and corporate update. This is an exciting time for Journey Medical. Our commercial business has seen a strong rebound this quarter.

And as we recently announced, our Phase 3 trials for DFD-29 treatment for rosacea, achieved the co-primary and all secondary endpoints with no significant safety issues. I will begin by making some brief comments on the clinical trials and will then be joined by our Vice President of Research and Development, Dr.

Srini Sidgiddi, who will present this clinical data in greater detail. Immediately following the presentation, we will review our second 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 Dr.

Sidgiddi is reviewing the data from the Phase 3 trials. We are very pleased with the positive results of our two Phase 3 clinical trials evaluating DFD-29 for the treatment of rosacea, which demonstrated statistical superiority over both Oracea and placebo.

This is a significant milestone for Journey Medical and potentially the broader dermatology community. There were approximately 4 million 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-29 in the second half of 2023.

If approved by the FDA, we believe that DFD-29 has annual peak sales potential of $300 million globally. With these clinically meaningful outcomes, DFD-29 has the potential to become the new treatment paradigm for the millions of patients suffering from rosacea as the lowest dose oral minocycline on the market.

The success of the program is a direct result of the exceptional collaboration between Journey Medical, Dr. Reddy’s, the investigators, and all the others that have been involved. We believe the potential approval of DFD-29 will be a transformational event for Journey. At this point, I would like to turn the call over to Dr.

Sidgiddi 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..

Thank you, Claude. I would like to begin by reviewing the highlights from the Phase 3 for the DFD-29 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 Dr.

Reddy’s has conducted two Phase 3 studies for the DFD-29. The Phase 3 studies had the following key design elements. Each study enrolled approximately 320 patients with moderate to severe papulopustular rosacea in a 3:3:2 randomization to DFD-29 Oracea placebo.

The first study, MVOR-1 enrolled all patients in the USA, while the second study MVOR-2 enroll patients in a ratio of approximately 70:30 in the US and Germany. Of the total of approximately 640 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 three or four 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 two co-primary endpoints, First proportion of subjects with IGA treatment success; second, reduction in total inflammatory lesion count.

The results show that DFD-29 was statistically significantly superior to both placebo and Oracea with 16-weeks treatment duration. The proportion of subjects that showed IGA treatment success was 65% for DFD-29, 46.1% for Oracea and 31.2% for placebo in MVOR-1.

The p-value for the difference between DFD-29 and Oracea was 0.014, while it was less than .001 against placebo. In MVOR-2 to the proportion of subjects that showed IGA treatment success was 60.1% for DFD-29, 31.4% for Oracea and 26.8% for placebo. The p-values were less than point .001 for DFD-29 against both Oracea and placebo.

In MVOR-1, the reduction in total inflammatory lesion count was 21.3 lesions for DFD-29; 15.9 for Oracea; and 12.2 lesions for placebo. The p-values were less than .001 for DFD-29 against both Oracea and placebo.

In MVOR-2 the reduction in total inflammatory lesion count was 18.4 lesions for DFD-29,14.9 lesions for Oracea, and 11.1 lesions for placebo. The p-values were less than .001 for DFD-29 against both Oracea and placebo. As can be seen from the data, DFD-29 has consistently outperformed both Oracea and placebo on the two key endpoints in both studies.

DFD-29 has shown statistically significant reduction of erythema in both studies compared to placebo. DFD-29 has also demonstrated statistically a significant improvement in quality of life against placebo with regards to two 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 the rosacea specific quality of life tool, RosaQoL that is Rosacea Quality of Life. Finally, we are pleased to say that DFD-29 also has shown rapid onset of action.

That is, it has shown statistically superior efficacy over placebo on both IGA success and lesion count reduction from week two onwards, which is a very significant achievement, considering these were monotherapy studies.

On the safety front, DFD-29 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 DFD-29 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 DFD-29 to capture significant market share upon its launch, based on the significant differentiators it brings to the table.

I will now hand it back to Claude to discuss our second fiscal quarter results in more detail. Thank you..

Thank you Dr. Sidgiddi. 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 second quarter surpassed our internal expectations, generating $17.2 million in net revenue, which corresponds to a remarkable 41% sequential gain over Q1 2023. Some key highlights noteworthy of mentioning.

Our leading core product Qbrexza led the way with net sales of $8 million in Q2, compared to $4 million in Q1, which is an outstanding 97% increase, in addition to achieving a new quarterly all-time high for the brand. Accutane, currently our second highest volume core product in our portfolio, had an impressive gain as well.

Accutane had net sales of $5.5 million in Q2, versus net sales of $4.6 million in Q1 of 2023, which is a 20% increase. In our third and fourth position of priority, we saw sequential increases in Amzeeq, net revenue of 15% and Zilxi of 82% versus their Q1 results. We expect these trends to continue as we build momentum.

Our legacy brands which are Exelderm, Targadox and Ximino 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 in executing our strategic plan.

Journey continues making great strides towards the guidance that we gave during our 2022 10-K earnings call and which is achieving non-GAAP adjusted EBITDA positive for calendar year 2023. Our entire organization has taken the necessary steps in becoming more efficient in optimizing our business goals.

A key example of this effort is limiting our SG&A spent. Journey has successfully reduced SG&A expenses in Q2 2023 by over $3 million compared to Q2 2022. We remain steadfast in our efforts and well on track of achieving a projected reduction of over $12 million in SG&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. We are certainly trending towards meeting our financial objectives, and continue to expect this trend to continue into the second half of 2023.

Finally, I am pleased to announce that we have paid off the entire debt facility we had with East West Bank. Journey now has zero bank debt. With that, I'll now turn the call over to Joe, who will review our financial results for the second quarter..

Thank you, Claude, and hello, everyone. I will now review the second quarter financial results for 2023. As Claude mentioned, total net revenues for the second quarter of 2023 were $17.2 million, 41% increase from $12.2 million in the first quarter, and a slight decrease of $1.1 million from the prior year quarter.

The decrease from the prior quarter is primarily due to lower unit volumes from our legacy products Targadox, Ximino and Exelderm, substantially driven by continued generic competition for Targadox.

These results were offset by an increase in net product revenues from our four core products, Qbrexza, Accutane, Amzeeq and Zilxi, primarily due to increased unit volumes as a result of our focused sales and marketing emphasis on these products, which led to 90% growth for these products combined from the prior year quarter.

These products combined reflect approximately 92% or $15.6 million of the company's total product revenues for the second quarter of 2023. R&D expenses decreased by 32% in the prior year quarter related to lower clinical trial expenses for DFD-29 with the project wind down.

SG&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&A expenses to better align costs, with revenues being generated. In connection with this cost reduction initiative, we executed a headcount reduction to our sales force, implementing 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 million of annual SG&A expenses. In the second quarter of 2023, we recorded $3.1 million non-cash impairment loss towards the Ximino 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 determine that the revision constituted a triggering event.

We reviewed the undiscounted future cash flows identified for Ximino and the results of the analysis indicated that the carry amount of the Ximino intangible asset on our balance sheet was not expected to be recovered.

GAAP net loss, common shareholders was $8.4 million or $0.46 per share basic and diluted for the second quarter of 2023 compared to a GAAP net loss of $10.1 million, or $0.57 per share basic and diluted for the first quarter of 2023 and $7.5 million or $0.43 per share basic and diluted for the second quarter of 2022.

Our non-GAAP adjusted EBITDA for the second quarter of 2023 resulted in a net loss of $600,000 or $0.04 per share basic and diluted compared to an adjusted EBITDA net loss of $5.3 million or $0.30 per share basic and diluted for the first quarter of 2023, and an adjusted EBITDA net loss of $2.6 million or $0.15 per share basic and diluted for the second quarter of 2022.

We are well on our way to becoming non-GAAP adjusted EBITDA positive in 2023. At June 30, 2023, we had $17 million in cash and cash equivalents in restricted cash as compared to $26.1 million at March 31 2023. At December 31, 2022, we had $32 million in cash and cash equivalents.

From the cash burn perspective, in May 2023, we paid down $10 million of our term loan and our $3 million revolver with East West Bank. Subsequently, in July of 2023, we voluntarily paid off the entire $10 million 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. And now I'll turn it back to Claude..

Thank you, Joe. In summary, I'd like to recap the highlights discussed on today's call. First, DFD-29 achieved outstanding results. DFD-29 showed superiority to current standard of treatment Oracea. We met all primary and secondary endpoints. 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 million globally. Second, our Q2 2023 financial results rebounded from Q1. In Q2, we were up 41% over Q1 net sales, over 90% of revenue in our core four promoted products. Third, the East West Bank full debt payoff happened in July.

We are confident in our ability to have enough cash to see DFD-29 through approval. Fourth, we are targeting operational profitability non-GAAP adjusted by end of this year 2023, the R&D expenses winding down with completion of our Phase 3 studies.

And finally and fifth, our BD team continues to be opportunistic in looking at various commercial stage assets to add to our portfolio. Plus, we look forward in continuing to work on out licensing efforts with our current product portfolio and as well as with DFD-29 and its successful Phase 3 trials.

We look forward to sharing our ongoing progress for both our commercial and clinical business when we report our third quarter results in November. Thank you and have a good day..

We will now begin the question-and-answer session. [Operator Instructions] Our first question today comes from Scott Henry of Roth Capital. Please go ahead..

Thank you. Good afternoon, tremendous improvement from the first quarter. 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. Shifting gears, and I want 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?.

Joe, would you like to take that please?.

Yeah, Scott, we had $8.75 million of restricted cash on the books. And it was definitely paid off with that..

Okay, excellent. And then your target of being EBITDA positive for the year, you know, 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 first quarter.

To do that, do you expect that to be driven by higher revenues or lower expenses? Or a little bit of both?.

Scott, to --.

Yeah. That Scott -- go ahead Joe, please..

It's going to be a little bit of both, Scott. So the second quarter still had some residual expenses in there from the cuts, right. So April and May still had some higher expenses in there. So the third quarter, fourth quarter are going to show the true cuts. And also from a revenue standpoint, we expect to be sequentially better..

Okay, great. Now, I just want to shift to DFD-29, 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?.

Sure, Scott. Yeah, in terms of uptake, and launching DFD-29, 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 two to three years, as the peak annual sales ramp up.

You know, 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-29.

What's key with this asset is the ability of us not just sticking in the oral systemic marketplace but this drug candidate, DFD-29, has the ability to go into the topical market, which has a much greater potential. So you're looking at 4 million 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..

Okay, and just following up on that, because I think you're correct and I believe the rosacea market is about 90% topical and maybe 10% oral which is Oracea.

You know, in the acne market orals have done very well, you know, well, if we think about the acne market, what percent is oral versus topical, so we get a sense of the ability to expand into that topical market with a better product offering?.

Yeah, 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 in the acne arena. But you're right about that percentage, it holds true on the rosacea side.

So about 360,000 prescriptions, 400,000 prescriptions for Oracea last year and about 3.6 million of the topical, so very close to those percentages..

Okay, and then just a 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, pretty close to break-even from here as well?.

Yeah, I'll start with this one, Joe. Yeah. So far, like you said, we've had an exceptional second quarter. We've really cut our losses dramatically. You know, adjusted 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&A’s falling allows us the ability to go for, all the way through the end of 2024, as a matter of fact, Scott..

Okay, great. I'll jump back in the queue. Thank you for taking the questions..

Our next question comes from Kalpit Patel of B. Riley. Please go ahead..

Yeah. Hey, good afternoon, and congrats on clearing the Phase 3 studies for DFD-29. Maybe I'll start with a couple of questions on this asset.

You obviously beat both placebo and Oracea in the Phase 3 studies, maybe give us a sense of how reflective were the patients enrolled in the trial compared to the real world population they gets Oracea today?.

Sure, I'll tell you, I think Dr. Sidgiddi could take that and talk about the inclusion criteria and of real world types of patients. And we also have a guest investigator dermatologist, Dr. Neal Bhatia, and perhaps he can follow up to Dr. Srini’s comments..

Thanks, Claude. And that's a great question, Kalpit. The inclusion exclusion criteria that we had on these studies were very much reflective of the real world population for rosacea. The kinds 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 Neal.

Neal, could you please explain a little more?.

Yeah, hi there.

Can you guys hear me okay?.

Yes, we can. Hi, Neal..

Good morning, Neal. .

Hi, everybody. I'm Dr. Neal Bhatia in San Diego, I was one of the investigators for this study. I've worked with Journey as well as Dr. Reddy labs for many years, just as a side.

I think, commercially the dermatologist, we have not been seeing much supportive oration from Galderma, neither their generic nor their branded, in the past years, so due to their inability to cover the market. That 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 Epsolay, the Dermavive, Soolantra and metronidazole. But even those 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.

So 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. I 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..

Okay, understood. And Dr.

Bhatia since we have you here today, I guess, can you 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?.

Yeah, I mean, the doxocy -- let me sit back, the tetracycline family as a whole impacts a number of processes that stop 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 targets, so 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, you know, the DFD-29 product, 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, you know, 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. So I think in the end, rosacea patients, you think about an average 30 something old, they have a high copay, 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 just the symptoms. So I hope that makes sense. I don’t want to be [scientific] for you. .

No, that's helpful. And this one, I believe, is an extended release or, it's a special formulation of minocyclin.

Do you see any advantages here in terms of the safety profile or tolerability profile, versus just using generic immediate release minocyclin tablets or capsules?.

I 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. Minocycline 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, is better absorbed in the fat and the pilosebaceous unit and the middle layers of the skin, which is why it was always a better drug for acne than doxycycline.

From a logistic standpoint, and this might sound selfish, is 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 to us on doxy. And we'd say, well, let’s switch it up.

So there's going to be a little bit of possession that the dermatologists will feel when they get their hands on this..

And maybe one last market opportunity related question here for your doctor.

If assuming this drug gets approved, what proportion of your rosacea patients would you prescribe this drug and what proportion would you continue to use Oracea?.

Oh, sure. 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.

And in all fairness, there's probably going to be a few dermatologists who say, no, I am not comfortable with minocycline. So all of that will be up to Journey to kind of bring all those mindsets forward and approach the marketing that way. As, you know, I'm educator myself, I speak at conferences on rosacea, I publish textbooks.

I would have no problem talking about safety first, and talking about here's an efficacious approach to the process of rosacea with an oral route. And I would probably work on convincing my colleagues to maybe get off the ledge rather than be concerned with what we used to know about your father's minocycline, if you want to call it that..

Okay. Okay. And maybe one question for the company, the clinical trial itself. How did erythema fare in both of your studies? I believe in Orascea’s pivotal studies back in the day, we saw a statistically significant improvement at least in one of those two studies for erythema.

Can we see that here as well?.

Srini, can you take that one, please?.

Sure, Claude. So Kalpit, you are rights. Back in those days, Oracea had a parasitical 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 find out from their own end, that there was no significance on both the studies.

Now, coming back to our studies, we did study the impact on erythema as an important secondary endpoint. And we found that both the studies have shown statistical significance against placebo for DFD-29. So that's going to be one of our key messages on the NDA filing..

Okay..

Yeah, if I could add to that. If I could like to add just real quick, and all of that is correct. You know, the clinical erythema assessments 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 papulopustular 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 erythema or the background erythema, they're going to let you know..

Okay, thank you very much for taking the questions..

[Operator Instruction] With 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 now disconnect..