Journey Medical Corporation

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to Journey Medical's second quarter 2025 financial results and corporate update conference call. At this time, all participants are in 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 webcast replay of this call will be available approximately one hour after the end of the call for approximately 30 days. I would now like to turn the call over to Jacqueline Jaffe, the company's Senior Director of Corporate Operations. Please go ahead, Jacqueline.

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Morali, co-founder, president, and chief executive officer, and Joseph Banesh, chief financial officer. Joining for the Q&A portion of the call will be Ramzi Aloush, chief operating officer and general counsel, Dr. Srini Sidgiddi, vice president of research and development, and Louis Donati, director of market access. 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 files of the SEC today, and the company's press release that accompanies this call, particularly the cautionary statements in it. Today's conference call includes non-GAAP financial measures that Journey Medical believes can be useful in evaluating its performance. You should not consider this additional information in isolation or as a substitute for results prepared in accordance with GAAP. For a reconciliation of this non-GAAP financial measure to net loss, its most directly comparable GAAP financial measure, please see the reconciliation table located in the company's earnings press release. The content of this call contains time-sensitive information that is accurate only as of today, Tuesday, August 12th, 2025. 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 Morali, co-founder, president, and chief executive officer of Journey Medical.

Thank you, Jacqueline, and good afternoon to everyone on the call today. The second quarter of 2025 marks the first full quarter since we introduced Amrosi, our best-in-class oral rosacea treatment, into the market. Today, I am pleased to report that our second quarter net product revenue of $15 million included approximately $2.8 million of OMROSI sales, surpassing our prior year quarter sales and contributing to a notable improvement in the business gross profit margins. Our strategic initiatives aimed at optimizing operations and controlling our overall operating expenses further enhance progress toward our goal of becoming sustainably EVGA positive later this year. We continue to execute on the launch, with MROSI prescriptions increasing at an impressive pace as we gain additional traction with dermatology prescribers. Patients have positive experiences with the product, and we continue to expand the number of covered lives with health plan access to MROSI. As anticipated, Accutane sales were pressured due to aggressive pricing from generic competition. Sales of the product declined compared to the prior year period. However, we were pleased to see our growth brands more than offsetting the decline. While we worked to stabilize our Accutane business, we remained focused on the growth of Amrosi and Cubrexa, our number one and number two sales details, respectively. We believe that these products can drive significant revenue growth and earning power regardless of additional Accutane sales volatility if it continues. The awareness that we have created for Amrosi and the positive responses from physicians and patients thus far have become evident in the prescription trends for the product. Through the end of July, we've generated over 12,800 MROSI prescriptions based on TRX data from Symphony Health. Each month since we've launched MROSI, total prescriptions have reached a new high and on a weekly basis. Each successive week has come in higher than the prior week, with the exception of the Memorial Day and July 4th holidays. Additionally, I am pleased to report that in MROSI's third month of promotion, the product has achieved more than 10 percent share of new prescription demand among dermatology writers, which is our initial prescriber target. Supporting these strong prescription trends is the significant increase in payer access for Ambrosie, from 30 percent of commercial lives in May of this year to approximately 65 percent of commercial lives, as noted in our announcement in July. Our ability to obtain a strong base of plan access so early in the launch demonstrates the strength of our clinical package and the value proposition that Ambrosie offers to patients and payers. Additionally, on our first quarter earnings call, we announced that there were approximately 660 unique prescribers of Ambrosie at the time. Today, I am pleased to report that we have now seen over 1,800 unique prescribers for Amrosi to date. This is a testament to the effectiveness of our commercial team and the unmet need Amrosi is addressing. We are pleased with the progress that we have made in rapidly creating awareness for Amrosi and achieving the significant payer coverage, high unique prescriber count, and strong prescription ramp in a little over one quarter since promotion of the product began. As a result, we expect to build on this momentum, and the traction so far reinforces our confidence that MROSI will generate high contribution margins and provide significant leverage toward our overall profitability and growth. Importantly, our established dermatology commercial organization offers significant leverage as we grow our product sales. Our total operating expenses were mostly flat year over year, reflecting our higher gross profit margins and lower R&D costs. In addition, our cash management discipline resulted in a minimal cash use in the quarter, and as a result, we believe the company has the financial resources and is well-positioned to execute on our business plan through the end of 2025 and into the foreseeable future. During the second quarter, MROSI gained additional visibility with the product being featured in a segment on the Balancing Act on Lifetime TV. Additionally, clinical data from our Phase III program evaluating MROSI for the treatment of moderate to severe papulopustular rosacea in adults were presented at the Society of Dermatology Physician Associates, or the SDPA Summer Dermatology Conference in June. The data showed that MROSI provides consistent relief of key rosacea symptoms with no adjustments needed for patients based on body weight. Lastly, we were pleased to see Journey Medical's common stock added to the small cap Russell 2000 and broad market Russell 3000 indexes, broadening public awareness and institutional investor ownership of our shares. And just yesterday, we were honored to be in New York City to participate in the ringing of the closing bell for the NASDAQ exchange. We have achieved so much in recent months that it is hard to believe Amrosi has only been on the market a little over one quarter. Yet we believe the progress really speaks to the product's therapeutic value as the best-in-class oral rosacea treatment and its potential to become standard of care. Our dermatology folks commercial team is committed to monetizing this important asset And I believe that the execution on our launch progress so far is demonstrating our ability to take our company to new heights. I'll now turn the call over to our CFO, Joe Benesch, who will review the financial results for the second quarter.

Joe Benesch Thank you, Claude, and good afternoon to everyone on the call. The total net revenue for the second quarter of 2025 was $15 million. compared to $14.9 million for the second quarter of 2024. The second quarter of 2025 includes $2.8 million in incremental net product revenue related to the U.S. commercial launch of Amrosi. This was offset by a decrease in Accutane revenue of $2.3 million driven by generic competition. Our gross margin increased to 67% for the second quarter of 2025, from 61 percent in the prior period, the low overall product cost of goods mainly related to product sales mix, notably MROSI and Accutane. R&D costs were nil in the second quarter of 2025 compared to $900,000 in the second quarter of 2024. The second quarter of 2024 included MROSI pre-approval project expenses. Looking now to our SC&A expenses, SG&A increased by $1.6 million to $11.9 million for the second quarter of 2025, and $10.3 million for the second quarter of 2024. The increase is mainly due to the incremental operational activities related to the launch and commercialization at MMROSI. Continuing to our net loss for the periods. Net loss to common shareholders was $3.8 million, or 16 cents per share, basic and diluted, for the second quarter of 2025, compared to a net loss to common shareholders of $3.4 million, or 17 cents per share, basic and diluted, for the second quarter of 2024. The second quarter of 2024 includes NROC pre-approval project expenses. We ended the second quarter of 2025 with $20.3 million in cash. compared to the same $20.3 million at December 31, 2024, which reflects minimal cash burn for the year-to-date period. Thank you very much. I will now turn the call back over to Clyde.

Thank you, Joe. We delivered solid performance in the second quarter with Ambrosie leading the way. While it is still in the early days of the launch, Prescription volumes have shown strong initial uptake and are expected to continue on this path. We continue to educate physicians on MROSI's best-in-class product profile through our marketing efforts, conference attendance, and data presentations. We are also continuing to leverage the favorable peer-reviewed article in JAMA Dermatology highlighting the positive Phase III clinical results of MROSI as well as the updated treatment algorithms from the National Rosacea Society, citing Amrosi's utility in the treatment of rosacea, both of which were published earlier this year. These efforts are showing tangible results with the number of unique prescribers nearly tripling since May. Importantly, our strong early ramp in payer coverage, our patient assistance programs, and the availability of Ambrosie in the vast majority of dermatologists' preferred pharmacies also demonstrate our ability to execute on key launch tactics and ensure that patients receiving a prescription of Ambrosie are able to get that prescription filled. Given our execution thus far and the initial traction we are seeing, we believe that we are on pace to achieve our launch objectives and facilitate Ambrosie in becoming the standard of care in the treatment of rosacea. For the second half of the year, we remain focused on expanding the base of Ambrosie prescribers, growing prescription volume, expanding payer access, and converting more of the prescription volume into revenue. We are confident that the prescription ramp for Ambrosie will continue to build momentum and enable us to generate strong revenue growth going forward. This will enable us to further leverage our established dermatology infrastructure and our fixed costs, increase our margins, and accelerate our path to profitability. In closing, I believe that we are well positioned to achieve our core objectives, which are to improve the lives of patients, offer healthcare providers innovative treatment options, and create long-term value for our shareholders. Thank you, operator. We are now ready to open the lines for Q&A.

Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your touch-tone phone. 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 questions, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from the line of Thomas Flatton with Lake Street Capital Markets. Please go ahead.

Good afternoon. I appreciate you taking the questions and congrats on a solid and rosy performance. Claude, you mentioned coverage being 65% or so. What is your goal for the end of the year?

So, thanks, Thomas. Good to talk to you. The managed care and the payer percentage, I'm going to pass that along to Ramsey Alouche, our CEO, to answer that.

Hey, Thomas. Thanks for the question. So, in terms of coverage, yeah, we did disclose that we're at 100-plus million lives, about that 65% or so. We haven't publicly disclosed what that target is going to be. We are continuing to grow that. What I can tell you is that's the quantity side, so we're building out the framework. It covers, again, over 100 million lives, so that's access to the MROSI drug. We're also working on the quality, so that's, you know, getting it on formularies, getting that implementation. That takes a bit more time as well, right? So it's a two-pronged approach. They run parallel, so we'll continue to increase the quantity coverage as the year goes on, but it's also equally as important to get the quality so we can convert that into revenue.

Awesome. Thank you for that. And then maybe one for Joe. You know, I have a nice step up in gross margins. Can you just give us a sense of how you see that evolving over the course of the year? Should we assume incremental improvements in gross margin over the second half of the year?

Yes. Thanks, Thomas. So product mix is really the driver of the gross margin. You know, MROSI is a very low-cost product. So we expect this to continue. We believe it represents a reasonable baseline going forward. So it then really becomes a larger percent of our margins. With the sales mix, we expect the margins to improve.

Got it. And then just one quick final one from me. What do you need to see or at what point do you think you'll be comfortable giving guidance for the year and then looking into next year certainly?

Yeah. Thomas, you know, as you're aware, we just finished our first quarter right now, and it's really early in the start of a brand-new launch. So we're going to wait a few more quarters before we give hard guidance in that. So it's real early, and it's going to just take a little bit more time.

Got it. Appreciate it. Thank you, guys.

Thank you. Next question comes from the line of Scott Henry with AGP. Please go ahead.

Thank you. Good afternoon, and congratulations on a great start for Amrosi. It's been impressive. A couple questions. First, if we just take the revenue for the quarter and divide it by the prescriptions, that generates a revenue per script of around 375, depending exactly what numbers you use. I think the expectation would be around perhaps $300 net revenue per script. But there's a lot of noise in the early quarters. Just curious your thoughts on what we could expect for a net revenue per script, you know, given some of the data that you've seen over the past quarter.

Yeah. Hi, Scott. I would tell you that I wouldn't recommend just doing that simple math on volume and the reported sales. We still have a significant proportion of Scripps utilizing our patient assistance program and coupons, and there could be significant delays in reimbursement from payers. So at this point, we're not going to give guidance to that ASP program.

Okay, now that's, I mean, it makes sense. There'll be a lot of noise, certainly in these first couple quarters. One of the other trends I wanted to get your thoughts on was how we should think about the summer seasonality for the rosacea market. I mean, typically, derms see less patients in the summer. They're out in the sun, their skin is drier. Do you think That is correct, and perhaps that bodes well going into the fall months.

I think the market has been stable. There is some seasonality with it, to your point there. But overall, I would expect, you know, right now we are at a good pace. Our ramp is moving along nicely week over week, month over month. We're seeing some really good growth because it is a brand-new launch with Ambrosie. So I don't think the seasonality is going to come into play much at all at this point. And I think as the product matures well into year two, three, I think that would become more of a factor.

Yeah, I was thinking more that it could be a tailwind coming out of the summer, meaning you've got a good launch going in one of the tougher seasons. So that could be a nice tailwind when we get into the fall. But I appreciate your comments.

No, I agree with that, yeah.

Okay, great. And then a final question, just could we get, Joe, maybe you could give us a number for CubeRexa. I mean, it looks like it was around 6.3 million.

For what, the year or the quarter? For the quarter. Right, 6.9 for the quarter.

Okay. Okay. Great. Thank you for taking the questions.

You're welcome.

Thank you. Next question comes from the line of Mayank Mamdani with B-Rally Securities. Please go ahead.

Yes. Good afternoon, Tim. Thanks for taking our questions and congrats on the strong start to MBC launch. Also, a follow-up to a prior question, the impressive NRX volume growth that we're seeing, trying to reconcile that with the sales you have here, 2.8 million, and then the 2.1 million stocking you had in 1Q. Can you maybe just give a little bit more color on how the pair rebating and also maybe any stocking dynamics we should be aware of, and then I will follow up.

Yeah, I mean, I'll take one part of that. Early when we first got all of our inventory needed to launch the product successfully, We did do stocking of the channel, if you will, in Q1 late March of this year. And now you're just seeing the ramp picking up and just moving along in its cycle and the internal expectations that we've expected. In terms of the payer and the copay assistance program, that dynamic is going to change over the next several quarters and evolve. We expect as more managed care and the different plans sign up, we're going to have less utilization of the co-pay assistance program and more coming in through the managed care program. So that's evolving right now, and as we pick up volume with prescriptions, again, as we're seeing from month to month to month, that dynamic will change as well.

Yeah, and just to add to that, the demand that's getting driven right now is really assisting us in our negotiations with managed care. We did announce, I think, in July that we signed up with one of the largest GPOs, and we are in late-stage discussions with the other two. But it does take time, right, for implementation with the plans, with the pharmacies, to start to see that covered prescription volumes. go up. We're monitoring that. We're working the channels top to bottom with the plans. There are a number of plans, so many. We're being diligent with all of that. Again, it will all convert to dollars. It does take time. We launched, I think, April 7th. We're pleased with the progress that we've accomplished to date.

Great. Then on the 10% market share that you report among high volume dermatologist target initial segment. What's the, is there like a year end goal that you have? And are you able to share any, you know, early refill kind of adherence trends for MROSI and maybe put in context what we may have seen with Aurasia when they launched? Thanks for taking our questions.

Yeah, so I'm going to speak in generalities here because, you know, we just haven't given guidance. And, again, the launch is off to a great start, right? We're three, four months into it now. So the 10% NRXs in June is fantastic. We see that continuing to grow. In terms of NRX to TRX refills, we're seeing a strong uptake. And, again, that is growing as well from month to month. I'm not going to give specific ratios quite yet on that. And then the NRX and TRX expectations, you know, if we continue going the way we are, we'll certainly meet all of our goals that we want and that MROSI is delivering. I think the key is to take away, one, we went from 660 unique prescribers to well over 1,800 prescribers. These are prescribers that we targeted. There was about 3,200 that we've looked at and have gone after. So we've done a great job in getting access to them and getting them to give trial to the product and ROSI. We're getting exceptional feedback in terms of how patients are responding when they come back in. And I think another dynamic that's important is that right now we are getting ambrosia filled for the most part with new patients coming in with rosacea. So that's really been what's been bringing this good, strong uptake. I think once they get really comfortable with that, we're hoping and expect to start seeing conversion from oratia over to ambrosia. And lastly, the launch of Horatio was 20 years ago. So it's very difficult for us, especially with the whole landscape of payers and managed care, to really look at that on the same playing field. So we're not looking at that as a strong analog to consider.

Fantastic. I'll hop back in the queue. Thank you.

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