Fortress Biotech, Inc. (FBIO) Q3 2025 Earnings Report, Transcript and Summary

Ladies and gentlemen, thank you for standing by. Good afternoon, and welcome to Journey Medical's Third Quarter 2025 Financial Results and Corporate Update Conference Call. [Operator Instructions] Participants of this call are advised that the audio of this 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 1 hour after the call for approximately 30 days. I would now like to turn the call over to Ms. Jaclyn Jaffe, the company's Senior Director of Corporate Operations. Please go ahead, Jaclyn.

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Maraoui, Co-Founder, President and Chief Executive Officer; and Joseph Benesch, Chief Financial Officer. Joining for the Q&A portion of the call will be Ramsey Alloush, Chief Operating Officer and General Counsel. 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. 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, Wednesday, November 12, 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 Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical.

Thank you, Jaclyn, and good afternoon to everyone on the call today. The third quarter of 2025 was another period of solid execution for Journey Medical as we delivered 21% year-over-year revenue growth. I am pleased to report that EMROSI, our best-in-class oral treatment for the inflammatory lesions of rosacea contributed $4.9 million to our top line in Q3, an increase of 75% compared to Q2. Our legacy and core products, including Qbrexza, Accutane and Amzeeq and Zilxi were essentially flat sequentially compared to the second quarter of 2025. On a year-over-year basis, revenue for this product group in the aggregate declined 16%, mainly due to the impact from Accutane generic competition. Overall, we grew our product revenues by more than 16% compared to the same period last year, while our operating expenses rose just 9%. This highlights the leverage that we are beginning to generate with the launch of EMROSI and our established dermatology commercial infrastructure. We believe that this leverage will continue to increase as EMROSI's sales ramp has significant growth potential and our operating expenses are expected to remain relatively consistent. EBITDA continues to improve, and we continue to expect that Journey will become sustainably EBITDA positive in the fourth quarter. EMROSI achieved third quarter total prescription growth of approximately 146%, with 18,198 prescriptions in Q3 compared to the second quarter of this year with 7,394 prescriptions in Q2 as we have shown strong execution on our commercial plan. As is typical with pharmaceutical product launches, contracts are initially negotiated broadly with the 3 major GPOs, Ascent, Emisar and Zinc, and we have been very successful in the first phase of our payer strategy. As we previously announced in July, over 100 million of the 187 million commercial lives currently have access to EMROSI. Our market access team has successfully contracted with 2 of the 3 largest GPOs. And as we continue to pursue our strategy to broaden access further, we believe that contracting with the remaining GPO for EMROSI will be completed early next year. We are very pleased with our GPO contracting progress so far. However, downstream health plan formulary adoption and implementation takes time, up to 3 quarters on average once contracts are secured, which is standard for most drug launches. While some plans have immediately begun covering EMROSI prescriptions, many will take time to implement coverage and formulary adoption. In the interim, our patient co-pay assistance program is bridging the gap. As time progresses and as drug coverage increases, we expect reliance on our co-pay assistance program to decrease. Physician feedback, which has been a key driver in EMROSI's strong initial launch continues to be very positive with prescribers noting that their patients are doing exceptionally well on treatment. The feedback emphasizes EMROSI's clinical benefits, notably that EMROSI's early onset of efficacy in as little as 2 weeks of therapy. In line with this feedback, initial refill rates for EMROSI have come in strong. During the third quarter, refills and new EMROSI prescriptions were tracking at a 1:1 ratio. We believe that this metric indicates both prescriber and patient willingness not only to try EMROSI, but also to continue on therapy beyond an initial prescription. In addition to anticipated continued growth in new prescriptions, we expect that the ratio of refills to new prescriptions will also increase, which should help accelerate total prescription growth. Another key performance metric that we use to measure our launch traction is unique dermatology prescribers. On our last earnings call, we noted that approximately 1,800 prescribers had written a prescription for EMROSI out of the 3,200 oral rosacea treatment writers that we are targeting during the first phase of the launch. Today, I am pleased to report that the number has increased by approximately 50% to over 2,700 unique EMROSI prescribers, demonstrating substantial progress toward this objective and a key driver of initial product adoption. As our commercial team continues to recruit new EMROSI writers, we have now begun to focus on developing the base of prescribers that have already written an EMROSI prescription into consistent writers. In addition to our activities in the field, we remain active at key dermatology medical conferences across the United States to build awareness and momentum behind the EMROSI brand. To illustrate, we presented data from EMROSI's Phase III clinical trials at the SDPA 2025 Summer Dermatology Conference in June of this year. These data highlighted that EMROSI provides consistent relief of key rosacea symptoms with no adjustments needed for patients based on body weight. Additionally, EMROSI's proprietary formulation of a modified release 40-milligram dose comprised of 10-milligram immediate release and 30-milligram extended release, which is the lowest strength oral minocycline approved by the FDA, which we believe contributes directly to the safety, efficacy and tolerability, making EMROSI a best-in-class rosacea therapy. And more recently, we presented pooled Phase III data in a podium presentation at the 2025 Fall Clinical Dermatology Conference in Las Vegas, showcasing EMROSI's favorable safety profile results and superior efficacy compared to Oracea, the most widely prescribed oral rosacea treatment. Our pooled results featured data from a robust study population of 653 patients was impressive and our statistically significant superiority to Oracea was well received. The fall clinical meeting was well attended this year with over 1,800 prescribers at the conference. As key opinion leaders and dermatologists focused on what's new in dermatology treatment, we believe that EMROSI's podium presentation gained significant visibility at the conference. Reflecting on the year so far, EMROSI is off to a great start, and our focused dermatology commercial team is executing at the highest level. As a result, we believe that the ground is prepared for EMROSI to become a standard of care in the treatment of rosacea and for the product to generate significant revenue and cash flow for the company. And with that, I'll now turn the call over to our Chief Financial Officer, Joe Benesch, who will review the financial results of the third quarter.

Thank you, Claude, and good afternoon to everyone. I'll now take you through our financial performance for the third quarter of 2025. Total revenues for the quarter were $17.6 million, representing a 21% increase compared to $14.9 million in the third quarter of 2024. This growth reflects incremental net product revenue related to successful U.S. commercial launch of EMROSI, which has continued to meet our expectations since its introduction. Turning to margins. Gross margin was 67.4% in the third quarter compared to 69.4% in the same period last year. The decrease from quarter-to-quarter primarily reflects the favorable nonoperational adjustments and product mix that benefited Q3 2024. More importantly, we continue to see steady quarter-over-quarter gross margin improvement in 2025 from 63.5% in Q1 to 67.1% in Q2 and now 67.4% in Q3. This ongoing improvement is driven by higher revenues from EMROSI and Qbrexza, both higher-margin products, combined with lower overall inventory period costs. SG&A expenses totaled $12.1 million, up approximately 6% from $11.4 million in the third quarter of 2024. This increase reflects additional operating activities tied to the launch and commercialization of EMROSI. SG&A for the quarter also includes noncash stock compensation expense of $1.9 million compared to $1.5 million in the prior year quarter. We reported a GAAP net loss of $2.3 million or $0.09 per share basic and diluted for the third quarter of 2025. This compares to a GAAP net loss of $2.4 million or $0.12 per share basic and diluted for the same period last year. On a non-GAAP basis, both EBITDA and adjusted EBITDA improved from the prior-year quarter. EBITDA improved by $500,000 from a loss of $1 million in the third quarter of 2024 to a loss of $500,000 in the current quarter. We achieved positive adjusted EBITDA of $1.7 million for the third quarter of 2025 compared to $300,000 for the third quarter of 2024. We ended the quarter with $24.9 million in cash and cash equivalents as compared to $20.3 million at December 31, 2024. Looking ahead, we remain focused on disciplined expense management and margin expansion as we continue to scale EMROSI's commercial footprint and strengthen our product portfolio. With this focus, we believe we are well positioned to deliver improved profitability and sustained revenue growth over the coming quarters. Thank you very much. I will now turn the call back over to Claude.

Thank you, Joe. We delivered strong results in the third quarter with EMROSI already making a positive impact on our business. Total prescriptions for EMROSI more than doubled from Q2 to Q3, and the fourth quarter is already off to a strong start. The number of EMROSI prescription writers is now at its highest level to date, and we expect to develop the current prescriber base into consistent writers over the next several months. With the positive physician feedback that we have received so far, we believe that EMROSI is starting to gain brand recognition as the preferred oral solution for the treatment for rosacea. We have executed well in terms of our early payer strategy, and the focus remains on increasing access to EMROSI, as well as enlisting more of the downstream health plans to adopt formulary coverage for EMROSI in order to drive more covered prescriptions. All of these activities are key steps in developing EMROSI into the standard of care treatment for inflammatory lesions of rosacea, and we believe that we are on track to accomplish this. Based on the initial strong momentum we are seeing with EMROSI's launch, we are confident that EMROSI can reach its full potential in the rosacea treatment market. We continue to believe that EMROSI can achieve peak annual net sales of over $200 million in the United States and over $300 million globally. Meanwhile, financially, EBITDA for the company continues to improve from quarter-to-quarter, and we expect to become sustainably EBITDA positive in the fourth quarter of this year. We set out to make 2025 a transformational year, setting up the company for potential strong growth and cash generation, and our progress indicates that we are delivering on that promise. As such, I believe that we are well positioned to continue executing on our core objective to improve the lives of patients, offer dermatology health care 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.

[Operator Instructions] And our first question for today will come from Brandon Folkes with H.C. Wainwright.

Congratulations on all the progress. I guess, can you just talk about how you view the usage of your patient assistance program on EMROSI at this stage of the launch? And when you talked about it improving, do you see an improvement in 4Q or sort of in 2026? How should we think about that aspect of the EMROSI launch?

Sure. Brandon, it's Claude. So first of all, I think it's important to take a look at the progress we're making here commercially with EMROSI in particular. Again, when you take a look at revenues from Q2 to Q3, we've increased that by 75%. So we certainly like how things are being directed. Additionally, when you take a look at the strength of the commercial organization being able to create demand, we've gone from approximately 7,400 prescriptions in Q2 all the way up to about 18,200 prescriptions in Q3. So our focus is really to drive demand as quickly and continue to grow that month-over-month, quarter-over-quarter, and we're successfully doing that. Now where the co-pay assistance program comes into play, we've talked about the 3 major GPOs. We now have 2 of these GPOs on board. We certainly expect the last one to come on board in early 2026. So I think you're going to see additional value for that in terms of payers reimbursing for the claims as they come in. Our co-pay assistance program will have less balance in terms of more reimbursements will come as time continues. It takes about 2 to 3 quarters for that to adjust with each GPO and then the PBMs and the downstream health plans. So we are patiently waiting for that time to go. It's just the way the health care system has worked, it works out, and we see that continuing. More so, I would tell you, in 2026, where I think you'll see some significant gains and less reliance on the co-pay program.

Great. And maybe one just follow-up. You touched on the growth of EMROSI. And breadth of prescribing has obviously grown with the unique prescribers. It looks like depth of prescribing is growing quite nicely as well. So can you just talk about sort of the focus between breadth and depth of prescribers in 4Q and maybe in 2026 as well? What's going to be the focus? Where do you see the most significant growth for EMROSI near term in terms of depth or breadth of prescribing?

Yes. Okay. Well, I'll tell you, I think it's a combination of what you're mentioning here. We focused in on 3,200 physicians at the beginning of our launch. Again, brand-new launch, only 2 quarters deep into it so far. As I mentioned, we're up to 2,700-plus unique prescribers. And those are brand-new physicians breaking a 20-year habit of being reliant on Oracea. That was the only product that was indicated orally for inflammatory lesions. Now that EMROSI is here, I think our commercial team has done a great job building awareness that EMROSI is here, talking about the great benefits from the Phase III clinical trials. If I may, just highlight 2 things. One, we're showing a superiority in IGA success over a 60% greater than what Oracea demonstrated. And then when you take a look at inflammatory lesions, EMROSI is showing approximately a 30% better inflammatory lesion reduction. So I think that message is penetrating well. Physicians, dermatologists, HCPs and so forth are trying it on new patients right now. And as those patients come back in for their second visit to the dermatology community, they're seeing that those results from Phase III are actually happening in their own practices with their own patients. That's going to help build reinforcement, take those physicians that are writing maybe 1 or 2 prescriptions to doubling that and tripling that and so forth. So I think you'll see a snowball effect taking place there. And those are really new patients. I think you're going to see the fact that as there's more confidence that's built with the dermatology community, our sales organization, marketing organization will be asking for switches as well from Oracea over to EMROSI. And again, that takes time and just a little history to start to happen, and I think that will take place. There's about 14,000 dermatologists. We're only at 2,700 right now, and we're focused on a core. But naturally, we are calling altogether in our universe more than 5,000. So you'll see that number expand as well, and we're going to get more out of the ones that have been trying it and waiting to observe their patients coming back in. So the NRx to TRx ratio is going to benefit from this as well. So right now, it's about 1:1. In October, we're seeing about 1:1.2. And we expect that to go up to hopefully 1:3 and maybe even more than that, Brandon. So there's a lot of variables in play here, which really gives us great potential for fantastic success in becoming the standard of care in time.

The next question will come from Scott Henry with AGP.

Congratulations to the whole team on the EMROSI launch. It's been very impressive so far. Just a couple of questions, and I know I ask about this a lot. Revenue per script, looked like it was about $380 in 2Q, about $275 in the third quarter. Do you think the third quarter is probably a pretty good reflection? Or was there any stocking or destocking that could maybe move that number around? Just trying to get a sense of how we should think about that net revenue per script.

Sure. Always a good question, always a fair question, Scott. Gross to net is going to continue to vary as reimbursement for the product it's just very early. We're only 2 quarters into it, and it's just dynamic at this point. As I mentioned, we are going to be getting a third GPO into play here early in 2026. And I think we'll see some nice improvements with that once that takes place. And that's just part of the system. We have to give it a little bit of time. And that's really why we aren't giving any particular guidance to gross to net at this point in time. So I don't think I can give you any further precision on that than what you're coming up with right now. But again, it's going to vary from our co-pay assistance program. It will be used less as there's better reimbursement from managed care companies. Joe or Ramsey would -- I'm sorry, go ahead.

That's helpful. I appreciate that color. I don't know if any of the other team members want -- did you want them to mention anything?

Yes, I was just going to ask Joe or Ramsey, if you wanted to add anything to that.

No, I think just in summary, the more reimbursement we get, like you said, the less on the co-pay program. And we just can't give a number right now.

Okay. Fair enough. That's helpful. And then sort of a bigger picture launch question is we're trying -- always trying to get an idea of what the launch curve looks like. And from my perspective, it looks like at worst, it's a consistently growing launch curve, but probably more likely an accelerating launch curve. How do you view the launch curve based on the 4 or 5 months you've had? And any thoughts on that?

All indicators are pointing to a very positive launch. We're meeting our internal expectations for sure. I like what the sales force is doing out there. Again, those key indicators adding additional prescribers on board with our focus on 3,200 physicians to start. We're well on our way to attaining that. I would expect that we will get there and then we'll expand from that. So that's just one part of it. And I think the ratio between one new prescription to one refill will expand as well. And in time, think about it, we're getting 700, 800, 900 new prescriptions on a monthly basis now. Those are new patients coming into the market each and every single month coming on to the EMROSI brand. And if they continue getting those refills and getting -- expanding more than that first refill to 2 or 3, you can see that potential momentum really accelerate. So time will tell. We're definitely moving in the right direction here.

Okay. Great. Final question, just quickly. Among the other products, Accutane, you mentioned the generic competition. I think I just saw the Q come up. It looks like it did about $2.8 million in the quarter. Do you think that's starting to base out? Or is there some more -- another leg down? How should we think about that Accutane franchise?

Yes. I would tell you that Accutane is off to a good start here in Q4. I think that when we're looking at it, we're on a good position right now. We believe it's stable. You never know what the other generic competitors do if they really play with price again to drive that down and potentially take more market share. But all indications, we just had a nice uptick. We received October numbers right now. It's looking like it's stabilized from our vantage point right here. It's got a great name to it, lots of recognition. And this is a highly promotional sensitive area here. And I think with our team speaking to dermatologists about this, keeping it in front of their mind, I think we're in a good spot right now. So that's what I would say.

The next question will come from Thomas Flaten with Lake Street Capital Markets.

You may have mentioned it, and I probably missed it, but did you mention at all, Claude, what your retention rate has been of those 22 prescribers since launch? How many of them have continued to prescribe regularly since launch?

We didn't speak to retention of the 2,700 prescribers, I think you're saying. So we continue to gain, and we've got it split out, obviously, the ones that are writing 1 to 5 and then 5 to 10 and so forth all the way up to 20, 30, 40, et cetera, Scott, so. But we didn't break it down, but it's a wide array. And obviously, as we bring on new prescribers, they fall in the lower buckets. And over time, they get to move into the secondary and tertiary and so forth. So no specific guidance on that yet.

Yes. No, what I was trying to get at was, if there are those that might have trialed it a couple of months ago and not come back to it, I'm just curious if there are any learnings for why those doctors haven't rewritten prescriptions either for the same patient or for other new patients, if you have any learnings from that -- from those docs.

I see. So far, no real key learnings in that front of it. What we are seeing, I guess, to my point of view is we're getting trial for new patients, for doctors that have not initially tried it. So they're starting to dip their toe in the water. And then I think you have a month or 2 until they get to see those patients back. You have the representatives going in, doing the regular call schedule, reminding the doctors, dropping off samples, talking about our co-pay program or managed care coverage and so forth. Like I said, that number continues to evolve. And we really see a lot of patients -- excuse me, HCPs that are writing more than one, but that takes about 3 months or so and then they start to catapult to the next level. Physician feedback has been exceptional. They really like the way the product is working. They like the side effect profile. Again, it's really just habit breaking of Oracea that they've been used to for so long. So we haven't gotten any critical feedback on the product.

That's great. And then just one final one, if I may. Qbrexza was down year-over-year, but up sequentially, but less than it was in Q3 '24. What impact has the launch of EMROSI had on how you manage around Qbrexza? Like what's the overlap of those 3,200 with Qbrexza writers? How are you trying to ensure that Qbrexza also maintains a good clip of growth?

Yes. So fortunately, for us, in terms of Qbrexza, we are in a real good position. We're seeing prescription growth compared to last year, even with the new entrant, the new competition that came in early this year. So prescription-wise, we are right on schedule, and we're going to have good single-digit growth year-over-year, again, with Qbrexza. The overlap with EMROSI is working out just fine because right now, you've got Qbrexza in a P2 position because EMROSI is here now, and that's going to be first and foremost. We've been calling on these doctors. We've had this product, Qbrexza since middle of 2021. Zilxi, which is part of our portfolio, was also -- gave us a great segue into introducing EMROSI, but those are the same doctors. Our called-on universe hasn't necessarily changed. So we're still reaching the physicians with the right frequency in a way that's been targeted. Our sales force is compensated heavily on Qbrexza. It's currently our #1 revenue generator for the quarter, for Q3, for example. And that will eventually become our #2 revenue generator as EMROSI continues forward. But we're in a good spot with it. And I think the competition has just increased the noise level of hyperhidrosis, and we've benefited from that.

The next question will come from Mayank with B. Riley Securities.

Congrats on a strong quarter. So on this ratio of paid scripts, how do you expect this to evolve with some of the payer updates you shared today? And I'm obviously just trying to reconcile sequentially revenue growth versus the TRx growth. And it looks like in October, you are month-over-month on TRx is about roughly 15%. So yes, if you could maybe just give us some color on how to think about sequential revenue growth versus sequential TRx growth? And then I have a follow-up.

Yes. Ramsey, would you like to start that off?

Yes, sure. In terms of -- as you're mentioning sort of covered claims, look, we're executing well against our market access plan. We are seeing some solid progress month-over-month. Claude had mentioned that early next year, we'll have the third of the 3 large GPOs contracted with. And it very much is a top-down approach. And there are multiple layers between GPOs, PBMs and the downstream health plans, right? And each one operates on its own schedule. But from our side, everything we can control is on track. Our market access team does have the strong relationships. There is value proposition for EMROSI that's resonating and payer feedback has been positive. So overall, we're pleased how these things are developing. It's exactly what we'd expect at this stage of launch. And as more plans and formularies adopt, you'll start to see that revenue -- that shift in revenue generation as well.

Yes. Mayank, I just want to add one thing here. Our focus right now is to continue to generate -- you were asking about the prescription and the payer relationship, if you will. We are going to continue to drive prescriptions. And each and every passing day, we expect to make more incremental gains on the payer front. And then early next year, I think we're going to see a larger access, which will mean better reimbursement for the company. So time is going to be our friend over time here over the next few quarters. But it does take a little while.

Yes. No, I totally hear you. And then on the duration of therapy that you've seen so far, I know you gave this refill to NRx 1:1 ratio, but is there any real-world data you have on persistence? And we have this concept of long-term responders or [ duratia ]. So I was just curious if you have learned anything in the real world on how -- what the duration of therapy would trend.

It's a great question. It's a difficult question to give you anything with hardcore data. Anecdotally, what we continue to hear is that they are seeing and appreciating the results the patients have. The feedback from patients has been very good. In terms of getting refills. We're seeing that. I think in another 5, 6 months, we'll be able to give you a more precise answer. But every indication looks like refills are going in. We're able to capture refill data internally with, in fact, our co-pay program as well as just reading the prescription numbers from Symphony and IQVIA. So all trends are positive. But we're hoping to see 3 to 4 refills at least through a 12-month period. You also have to take into effect rosacea, we have a very quick effect as little as 2 weeks, patients are seeing very good results with EMROSI. And obviously, it varies. Some people will take longer, some people will be at 2 weeks. But depending on how the flare-ups are, how long the rosacea stays calm until the next flare-up is another part of this that we're learning and keeping a close eye on.

Understood. And lastly, for Joe, on the financial piece. Your expectation for OpEx growth next year based on how launch is progressing, and it does seem -- you're tracking high single digit year-over-year this year. Is that a similar trend you'd expect next year? Just thinking about operating leverage also.

Thanks. Yes. So really, the key is leveraging our current infrastructure. The increase in expenses, any incremental expense should be more than offset by increases in revenue. Like we said in our prepared remarks, we expect to remain relatively consistent from period to period and into 2026. So as revenue grows, we think the leverage in our operating results will continue to come through. And any increase in revenue should support a higher revenue base also.

And this will conclude our question-and-answer session as well as our conference call for today. Thank you for attending today's presentation. You may now disconnect.