Journey Medical Corporation

Good morning and welcome to Journey Medical's Corporate Update Conference Call to review the EMROSI FDA approval received. At this time, all participants are in a listen-only mode. 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 replay of the call will be available approximately one hour after the end of the call for approximately two weeks. 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 morning, and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Morali, co-founder, president, and chief executive officer, Joseph Benesh, Chief Financial Officer, Dr. Srini Sidgiddi, Vice President of Research and Development, Ramzi Aloush, General Counsel and Corporate Secretary, and Dr. Scott Drew, a board-certified dermatologist. 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 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. The context of this call The content of this call contains time-sensitive information that is accurate only as of today, Monday, November 4th, 2024. 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.

Thank you, ladies and gentlemen, for joining our call this morning. These are very exciting times here at Journey Medical. Earlier today, we announced FDA approval of our product candidate, DFD29, which is a modified formulation of minocycline 40 milligram designed with a unique immediate and extended release profile to treat patients with inflammatory papulopustular rosacea. Along with the market authorization, the FDA has adopted our brand name for the product, MROSI. Not only did we obtain FDA approval with a label that clearly differentiates the product from current rosacea treatments, but we also achieved this on time with no development setbacks. Additionally, there are no special post-marketing commitments required for MROSI by the agency. We believe that the strong efficacy, safety, and tolerability results that we generated in our Phase III program, in addition to oral dosing, will support MROSI in becoming the standard of care treatment for patients diagnosed with rosacea. I am extremely proud of the work we have done with MROSI. Acquiring the asset with Phase II data, designing and conducting two successful randomized double-blinded controlled clinical trials, and completing the development through FDA approval. Importantly, we have proven our capability to fully develop late-stage product candidates in-house, which I believe is an important core competency as we continue to grow the company. With the approval in hand, we are now focused on three major areas where the newest addition to our dermatology product franchise can have a positive impact. First and foremost, we believe that MROSI's favorable efficacy and safety profile will greatly benefit the estimated 16 million patients that currently suffer from rosacea in the United States. MROSI will be the first new oral treatment for rosacea since Oracia was launched by Galderma back in 2006, nearly two decades ago. Second, to the practitioners that treat rosacea, MROSI brings new innovation and advancement to the field of medical dermatology. We believe that the strong data package backing MROSI, along with convenient once-daily dosing, will deliver on the promise of therapeutic improvement and provide physicians with a new compelling option for their rosacea patients. And thirdly, we believe that MROSI has potential to transform our dermatology business. Given its anticipated strong competitive position and our existing commercial organization, The rosacea treatment market comprises over 4 million prescriptions written annually, primarily by dermatologists for both oral and topical treatments. Importantly, we already have a strong call into prescribers in the rosacea treatment segment. Over 90% of practitioners that write for Oratia also have prescribed Journey products. Given our competitive coverage, of the rosacea treatment segment today, we believe that we have a major advantage ahead of Ambrosie's launch. As a result, we anticipate a rapid and robust sales ramp of this product and that the growth in sales from Ambrosie will leverage our current commercial infrastructure and become a significant contributor to both our top and bottom lines. Our objective is to become sustainably cash flow positive in 2025. With that, I would like to turn the call over to our Vice President of R&D, Dr. Srinivas Siddhiti, who will discuss Amrosi's novel formulation and the key clinical results that supported regulatory approval. After Dr. Siddhiti's prepared remarks, we will then hear from Dr. Scott Drew, practicing dermatologist who will offer insights into his practice and the treatment of rosacea. Srini?

Thank you, Claude. And hello to those of you on the call this morning. MROSI is a unique formulation, and we believe it has a very unique value proposition. It is the lowest fixed-dose minocycline product on the market, approved in any indication. The product is formulated with the multiple unit pellet system, or MUPS, which allows us to mix immediate release and extended release pellets of the active ingredient in the same capsule. The mix in EMBROSI consists of 25% immediate release and 75% extended release pellets, allowing for uniform drug distribution, absorption, and release in the bloodstream throughout the day. Pharmacokinetically, This results in lower plasma exposures and high levels of minocycline in the skin. From the beginning, MROSI was designed to fill gaps in the market for an oral rosacea treatment. These gaps include the unmet medical need for high efficacy in reducing inflammatory lesions and reliable safety and tolerability. The hypothesis for MROSI was that its formulation would result in better partitioning of minocycline into the skin. Both the Phase I and Phase II studies in Germany validated this hypothesis. Based on these study results, we made the decision to conduct the head-to-head studies with the standard of care oral rosacea treatment, that is, Oratia, pre-specifying our Phase III trial design for a superiority claim. As a reminder, our two phase three trials recruited 653 Rosacea patients with 15%, that is 96 subjects, coming from Europe. Despite initiating the two phase three trials during the tail end of the COVID pandemic, we recruited all of the patients for this study in just nine months, maintaining our initial timeline expectations. The phase three results that we achieved again proved our initial hypothesis and, in fact, exceeded our product design goals for efficacy and safety. The key endpoints in our trials included IgA treatment success and reduction in inflammatory lesion counts, as well as reduction in associated erythema. On the two key endpoints of IgA success and inflammatory lesions, In both of our phase three trials, we achieved head-to-head superiority against the market leader, Aurasia, with high statistical significance. We believe that having head-to-head superiority in the product's label is an important differentiator and a significant value add to patients and providers. To summarize, we believe that MROSI is the only approved treatment in the Rosacea treatment landscape. with head-to-head superiority data and placebo-like safety and tolerability. We believe that the first cycle approval from the FDA with no special post-marketing commitments highlights the quality of our clinical and regulatory program for ambrosia. With that, I'm pleased to introduce Dr. Scott Drew, a practicing dermatologist located in Marion, Ohio, who can offer a clinician's perspective on the FDA approval of Ambrosie. Over to you, Dr. Scott Drew.

Great, thanks very much. I appreciate the invitation. So I'm Scott Drew. I'm a dermatologist, but I've practiced for about 35 years in Central Ohio. We have three offices. And so why me? I am not an employee at Journey. I'm not paid for this. But I've been asked to discuss the importance of rosacea in my clinical practice. My practice is mainly in medical, surgical, inflammatory dermatology practice, and we have a very significant rosacea population in our practice. Let me help you understand, put some girders around what rosacea is. Not only is it a painful, obvious, inflammatory dermatology problem, harking back, if any of you are old enough to remember the days of Jimmy Durante and Carl Malden and W.C. Fields, it is a It is a quality of life concern. So imagine for a moment you have to go to an event, a cocktail party, an opening, a museum, a spouse's family event, and you've got horrible red bumps and pimples and pus bumps across your cheeks, forehead, and nose and chin, and you flush and you have heat and burning. People are embarrassed to be seen in those sorts of events. And it hurts. And left unchecked, it can progress, progress, progress to the point where you get that scarring, which you're all familiar with, with WCPOs and gemadurine. We call that FIMA. So there's also a medical component as well as a psychosocial component. And the numbers that Claude was proposing and the number of diagnosis of rosacea, that does not come into account the number of people who don't go to the doctor because they're told, oh, it's just cosmetic or that's the way you were born or your dad had that. So the prospective number of patients is even higher. And as Claude mentioned here before, we only have one really significant option, and that's oratia, which is, I think, comports about 30% of the market share. If you're thinking about trying to get your arms around how big rosacea is, well, there's a very popular band called the gin blossoms. And the gin blossom refers to W.C. Fields' explanation for his rosacea, because the blossom of my nose that was caused by the gin I drank. That's the misperception of what people think rosacea is. It's the stigma of alcoholism, which is absolutely not true. It's an inflammatory dermatology condition that can be controlled with medicines. And now we have a new agent available to us, thanks to Journey. which is just named yesterday. So that's a very significant outcome. Why is dermatology excited about this? Claude and his company thought a very strict protocol. We have a double-blind placebo-controlled study that's not just placebo-controlled, but also against an active comparator with a 60% improvement over placebo and a 30% improvement over the existing molecule that we have to us. And Journey has a well-established sales force and management force that is well known to all of us in dermatology across the nation and across North America that enables us to have access to the drug and access to our patients who then are provided patient education assistance. So this is a very, very exciting time because rosacea patients are frustrated, they're uncomfortable, they're in pain. And now we have another option to help them. And I, among my colleagues, are very excited to have this opportunity and this new agent to treat our patients. And I'll hand this back to Claude.

Thank you, Dr. Drew. I'd now like to take a moment to discuss the market research that we commissioned as we prepare for MROSI's launch. Importantly, the market research showed that approximately Seventy percent of dermatology practitioners would prescribe Amrosi due to the product's clinical profile, namely the statistically significant head-to-head superiority to Oration. Additionally, we surveyed payers that collectively represent over 200 million covered lives in the United States. These interviews showed that most, if not all, PBMs, GPOs, and other managed care organizations are likely to contract with us to provide health plan coverage for MROSI. Given the positive feedback from these initial surveys and the recent FDA approval, we now have the ability to meet with health insurance companies to negotiate contracts to get MROSI on-plan formularies around the country. We have previously guided for launch of MROSI in late Q1 or early Q2, with several activities for us to perform between now and the launch. These activities include building launch quantities, packaging and labeling activities, and importantly, conducting prelaunch discussions with health plans with the goal to have as many covered lives as possible with access to MROSI at launch. Additionally, we believe that launching in late Q1 or early Q2 is advantageous with deductible resets largely resolved by the second quarter of the year in the United States. Now I would like to turn the call over to our CFO, Joe Banesh to go over a few financial housekeeping items. Joe?

Thanks, Claude. Thanks, Claude. And thank you to everyone for joining us on the call today and for allowing us to share the great news on our approval. First, I'd like to start by sharing some pre-ardings guidance with you. We will be reporting our third quarter 2024 financial results on November 12th. Given that this is only one week away, I'd like to take this opportunity to provide select financial results in advance of our earnings release. For the third quarter of 2024, we intend to report product revenues of $14.6 million. As a result, we remain on track to deliver on our product revenue guidance for the year, which is a range of between $55 to $60 million. In addition, We anticipate that our expenses will come in at or below our expense guidance for the year, which is SG&A in the range of $39 to $42 million, R&D in the range of $9 to $10 million. Lastly, we expect to report that we ended the third quarter with approximately $22.5 million in cash, representing a modest cash burn of approximately $1.4 million for the quarter. This reflects positive cash generated from our core operations offset by MROSI pre-launch spend and non-operating expenses. We will provide more details on our third quarter earnings when we report our full financial results next week. Next, I'd like to provide some perspective on how the approval of MROSI will impact our financial position for the remainder of the year. As we have reported in our past filings, in January 2024, We paid a $4 million filing fee to the FDA upon submission of our NDA for DFD 29. Subsequently, we made a $3 million contractual milestone payment to Dr. Reddy's laboratories in April of 2024, based on the FDA's acceptance of our NDA. Furthermore, the approval of MROSI triggers an additional $15 million milestone payment to Dr. Reddy's, which is due in December of this year. We intend to fund this milestone with the $5 million available to us under our credit facility with SWK, approximately $4.4 million that we expect to soon recover from the cybersecurity incident that occurred in 2021, and cash on hand. Thank you very much. And I will now turn the call over to Ramzi Aloush, our general counsel, who will review Amrosi's IT position and our strategy to derive additional value from the product.

Ramzi?

Thanks, Joe. And thanks to all who have joined this morning's call. Along with today's exciting news, there are a number of potential catalysts that result from MROC's U.S. FDA approval. With respect to our U.S. issued patents, MROC currently has three patents that are expected to be listed in the FDA Orange Book that will provide patent exclusivity until 2039. These US patents focus on methods of treating inflammatory skin condition by selecting and administering an oral composition comprising a reduced dose of minocycline and the relevant pharmacokinetic parameters. Globally, we have several other issued patents and additional pending patent applications for MROSI that coupled with this approval and the significant clinical trial results allow us to explore other markets such as Europe, Asia, Canada, and South America. Looking at Europe specifically, given the robust patent portfolio for EMROSI and the significant number of European participants in our Phase II and Phase III clinical trials, we believe that there is a streamlined pathway to regulatory approval in Europe. This is further strengthened by the fact that EMROSI demonstrated statistical superiority against its active comparator, Oratia, in the Phase III studies, whereas in Europe generally, only demonstrating non-inferiority is required for regulatory approval. As a result, these factors have led to strong interest from potential partners in Europe, in addition to potential partners in other territories outside the United States. This ties back into what we have stated in the past, which is that a key pillar in our business development strategy includes out-licensing our intellectual property and related technologies to interested and capable pharmaceutical companies in countries of abroad. As a recent example of these efforts, last year we executed an out-licensing transaction with Maruho Limited, a dermatology-focused pharmaceutical company based in Japan, granting Maruho the rights to develop and commercialize Q-brexa in certain Asian countries, which resulted in an upfront payment of $19 million to Journey Medical. This was a significant milestone, which we look to replicate in the future, not only with Q-brexa, but with all of our patented products. particularly with Ambrosie's recent FDA approval. As we work to create shareholder value with the launch of Ambrosie in the United States, we remain active in our business development efforts and our objective to bring in additional non-volutive capital to the company throughout licensing. And with that, I'd like to turn the call back to Claude. Thank you very much.

Thank you, Ramsey. We believe that the approval of MROSI marks a significant milestone for Journey Medical and our shareholders. This high-value asset comes at a great time for the company and complements our proprietary core dermatology product profile. We expect a strong launch in the early part of 2025 with a focus on improving the care of patients with rosacea. educating our physician customers and health plans on the benefits of Ambrosie and leveraging our commercial infrastructure to continue to focus on opportunities to out-license the intellectual property on our patented products globally to bring in additional non-dilutive capital. As Jill mentioned, we will release our third quarter earning results on November 12th. Given this morning's conference call, we will provide our Q3 results in a press release, but will not host an earnings call next week. We are planning to host a pre-commercial update conference call in late January or early February next year to provide additional information on the upcoming launch of MROSI, including the progress that we are making on pre-commercial activities, launch timing specifics, and our commercial plans. Thank you for your attention today. Operator, we are now ready to open the lines for Q&A.

We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. The first question comes from Thomas Flatton with Lake Street Capital Partners. Excuse me, Lake Street Capital Partners.

Hey, good morning, everyone.

Go ahead.

Good morning. Many congrats on the approval. Claude, I was wondering if you might walk us through any discussions you had with FDA on the erythema data and the fact that it's missing from the label. Maybe you could just walk us through that.

Yeah, sure. Great question. I'm going to hand this off to Srini, and he'll go through that.

Srini? Thanks, Thomas, for that question. It was an important discussion. Based on the robust study data, we were expecting the erythema indication to be on the label. The FDA determined otherwise due to a concern that the prevalence of erythema across other types of rosacea could lead to confusion amongst the providers. We plan to publish the strong erythema data in a peer-reviewed journal and leverage it to the extent the regulations allow.

So that will be consistent with label promotional strategy, if I'm understanding that?

That's correct.

Got it. And then a quick one for Joe. Joe, I was wondering if you could comment on the significant upswing in gross margins in the third quarter.

Yeah, I'm really happy to show the increased gross margins. In the past, we've had some inventory charges that are well behind us. Our contractual milestones are at the lowest they've been. So we expect those margins to be where they are now and continue to grow in the future.

So we should use this as a baseline going forward? Yeah, okay.

I would use this as a baseline going forward, yes.

Excellent. I appreciate our hot back in the queue. Thank you.

The next question comes from Scott Henry with Alliance Global. Please go ahead.

Thank you. Good morning and congratulations on the great news. Just a couple questions. First, could you speak about the incremental cost of marketing in ROSI as far as do you expect to add reps and how should we think about the cost of promotion?

Yeah, thanks, Scott. Yeah, first of all, you know, we're very excited. In terms of MROSI and the marketing cost, additional marketing costs, I'm going to pass that part over to Joe, and he'll get into some of the specifics. Right now, our coverage with our current field force really is very sufficient. As I mentioned in the remarks, 90%. of the Oratia prescriptions that are out there have already, those prescribers have already been prescribing Journey products. So we feel that we've got very good coverage in that front. So in 2025, we are not expecting to add additional reps. We're very good as is. So Joe, if you'd like to talk about the marketing expenses, please.

Sure. So just to give you some perspective here, the key costs that we expect in the preparation of the launch primarily relate to manufacturing of the finished product lots. But in addition to that, you know, we'll have some incremental marketing and sales expenses on promotional materials, digital advertising, et cetera. Got all these expenses are in our launch plan and our budget forecasts. And, you know, we have the cash to get through it.

Okay, fantastic. And Joe, since I have you, when we think about revenue recognition for the product, it doesn't sound like there should be any sales in Q1, but sometimes there's a lag in terms of when that flows through into the income statement. How should we think about Q2? Do you think it will reflect demand, or should we see more demand reflection in third quarter. Just trying to get an idea of how we should expect revenue recognition.

No, I think you're going to see the demand immediately. However, until we get the payers online, our ESPs may be a little bit lower than expected, not expected, but as expected, a little bit lower. But you should see the demand coming right out of the gate.

Okay. And being recognized on the income statement as well. in line with that or will there be a delay? Okay.

No, there won't be a delay. We'll see it on the P&L, on the income statement.

And Joe, your expectation, I heard you say that you expect profitability in 2025. Would you also expect MROSI as an individual product to be profitable? That's pretty challenging in the first year.

Yeah, absolutely. It will be profitable in the first year and actually drive our margins a little bit higher.

Okay, great. Final question. I don't expect you to have an answer for it at this point in time, but any comments on price we should expect for the product?

Scott, you know, we will certainly go over that in our pre-commercial call early in next year, late January, early February, and we'll give the specifics on there. But you are looking at Ambrosie with great data, very compelling superiority. So I would anticipate it close to where Horatio is, if not with a little bit of a premium.

Okay. Thank you for that, Keller. Congratulations again, and thank you for taking the questions.

The next question comes from Kalpit Patel with B. Reilly Securities. Please go ahead.

Yeah, hey, good morning and congrats on the approval here. Maybe one for Dr. Drew on the line here. Doctor, I guess, you know, with Oratia not being generic and Ambrosie being available, how do you anticipate positioning this drug in the treatment landscape relative to Oratia?

Oh, thanks. Great question. A couple things. So, you know, generics are about 25% as bioavailable as a reproducible branded non-generic medication. That's one thing. Number two, beyond the generic availability, I think the data on the 33% superiority availability in the pivotal trials is going to draw people's attention because rosacea is this chronic inflammatory burden of life problem that And if I can give my patient a small, easily digestible, swallowable, one-fourth ER, three-fourths non-ER tablet to make them that much better with one tablet, I think that's going to be a no-brainer. Got it. How do you – I'm sorry. Go ahead.

I was just going to ask you on the erythema benefit. I guess how do you see the erythema benefit on this drug versus what you have seen in the real world for Oration?

Yes, thank you. And I want to expand on that earlier question that was asked about erythema and the unlabeled part of that comment. So I think the erythema is also going to be very, very profound. And I'm not too worried about the label consideration. And there's real world data to tell us that, you know, indications and labels are a far different animal than the reality of our practice. For example, we know that psoriasis affects skin and joints. And so we go ahead and treat the joint disease of psoriasis, even though it's not on label. We know that drugs often get the label, but that doesn't hinder the practicing dermatologist from making choices that best benefit their patients. And because journey has the indication for the rosacea, that will flow over onto the erythema. So I think that irrespective of the type of rosacea you have, you know, there are four subtypes of rosacea. I don't want to get into the weeds, but this is going to have an impact on all four of those types, including the one that's most frustrating, the erythematotelangiectatic rosacea. That's like 11 syllables. But that's the rosacea that causes that diffused erythema. the so-called slapped cheek, and you walk in and you look like someone just slapped the crap out of you on both sides of the face, that will impact that as well.

Okay, got it. Thank you very much for answering the question. Oh, great to be here.

The next question comes from Jason Wittes with Roth Capital. Please go ahead.

Hi, thanks for taking the question, and congratulations. So just in terms of timing, you kind of outlined sort of the initial launch, but in terms of when you're fully stocked and fully in the registries, et cetera, how long do you anticipate that would, how many quarters or how much time do you think that would take?

Yeah. Hi, Jason. Thanks for the question. Yeah, no, it's not going to take that long. As a matter of fact, our anticipation is right now to get the launch quantities needed in March I would imagine that you will see distribution into the product channels. That way the pharmacies have it on the shelf. The wholesalers, the three big wholesalers, will have it distributed to retail pharmacies. So it should be relatively fast. Within about a two-week period, it should be sufficient enough for us to start launching with our sales force to build that demand as early as April, possibly at the end of March.

Okay, great. And then maybe a question for the doctors that follow up to an earlier question. In terms of the label for, you know, there's no label for erythema as discussed, but, you know, you mentioned real world, you know, results are going to be impactful. I'm just curious, when you prescribed erythema in the past, has there been much impact on erythema? And, you know, assuming we see it, obviously, as the data shows for this drug, is that going to be highly influential in terms of how you prescribe and how other doctors prescribe?

Yes. And let me use some historical context because prior to the advent of Oratia, we were giving high-dose metacycline, high-dose doxycycline in the 100 to 200 milligram dosing per day. And that was in adjuvant therapy with things like topical metronidazole, topical sodium salicylamide, uh topical ivermectin which has made news of late um and so the advent of oratia enabled us to reduce the dose of the of the antibiotic component of that to a sub-antimicrobial dose eliminating the whole issue of um a myriad of issues of adverse events not the least of which is antibiotic resistance So that was very, very important. And Oracia did make an impact in erythema and made an impact in the decreased lesion count. And let's not forget the issue of quality of life. Now, however, we actually have clinical data to tell us that the erythema is going to get better, 30-some percent better than with Oracia. And we are going to have difficulty ascertaining against genericization. But again, with the bioavailability difference, we're going to see significant improvement. The other thing that Claude mentioned, this is new and exciting, and we dermatologists by nature like new and exciting. And our rosacea patients who are still on oracea, frankly, are frustrated. And so we are going to be able to come in and help these people get rid of that redness and get rid of those pustules. So I think the short answer to your question is yes. And I think as soon as we get our hands on it, we dermatologists are going to be eager to attend to that. In fact, many of us, you all individually go to your own private dermatologist. You know, we all have signs on the wall about various conditions. And all of us, all of us have rosacea posters on the walls. It's rosacea and onychomycosis, nail fungus. They're all on our walls because patients have been told for decades that there's no treatment for that. It's just a red face or it's just rancid nails, and don't worry about it. Well, when people come in for their skin cancer or whatever, they look at those pictures and think, well, you can actually do something about that? And we say, yes, we can. And that also drives the market, in which I also think that number of $16 million might be a bit low. Great. Thanks. I'll jump back in here.

The next question comes from Brandon Foulkes with Rodman and Renshaw. Please go ahead.

Hi. Thanks for taking my questions, and congratulations on the approval. Maybe, Claude, can you just elaborate on the insurance coverage? I know you did sort of mentioned you expect good coverage at launch, but how should we think about that in the context of achieving, you know, what would be considered maybe full coverage or, you know, end of 2025 coverage? And should we expect any patient assistance programs as coverage comes online?

Yeah, absolutely. I think a couple things. Now that we have the approval we have the green light to begin our discussions and negotiations with all of the healthcare plans. And those will start immediately. I think we'll start to see in about five months or so the coverage start to really become quantifiable and you'll see that really continue through about 12 months, a little bit longer as we launch the product. Six months after the approval, we'll start seeing some good coverage happening. And then over that year, we'll get optimized. So we'll work on getting towards that 200 million lives in terms of coverage. And you'll see that coverage increase on a monthly basis, quarterly basis.

Great, thanks. And just one more, if I may. You know, you've obviously had tremendous success here in getting this approved. Does that change your risk appetite at all in terms of business development and perhaps maybe looking at more development stage assets in future versus commercial stage assets, just given your success here?

Yeah, I'd like to start out by saying, you know, we have really built together a fantastic portfolio of products here. that have good IP and NDAs, and we continue to be looking for differentiated products that offer good relief for patients and good opportunities for dermatologists to choose from. So we're going to continue to look at commercial products, but we certainly have an appetite for late stage assets. I'm going to pass the mic over to Ramzi Alush. elaborate a little bit more on this.

Great. Brandon, thanks for the question. So in terms of our business development strategy, there's really three pillars. Obviously, we discussed the outlicensing as one, where we're monetizing our intellectual property abroad. I think that's a strong way to bring in non-dilutive capital to the company and allow our products to be launched in other countries. The second part is really two-pronged. It's the commercial assets that are on market that are either deprioritized or mismanaged, right? And that's what you've seen in the past in terms of, you know, our acquisitions of Kebrexa, Amzeek, Silksy, so on and so forth. So that's certainly still part of our strategy. And in terms of risk appetite on the late stage development, I think our strategy remains very similar where we like low risk, you know, proven out phase two data readouts on clinical programs. that have a controlled phase three budget for spend, and then, you know, you'll see the success. For example, DFD 29, right, up to $25 million in R&D expenses, capital efficient terms with our partners, and then you can see here the tremendous opportunity that the results have, you know, created. So I think in terms of risk, you know, we're right where we need to be, very similar to what you've seen with DFD 29. is what we'll be looking to replicate, hopefully, in the future.

Thank you to you both, and congratulations again, and congratulations to the whole journey team. Fantastic achievement. Thank you.

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

Thanks. We appreciate you all tuning into this call today on short notice, and we appreciate all of your good questions. Also, I would like to thank Dr. Drew for offering his insights today. We look forward to reporting our third quarter earning results on November 12th and to delivering on a strong launch with MROSI next year. Have a good rest of your day.

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