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Fortress Biotech, Inc.
11/12/2025
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. At this time, all participants will be in a listen-only mode. Should you need assistance, please signal conference specialist by pressing the star key followed by zero. 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 one hour after the call for approximately 30 days. I would now like to turn the call over to Ms. 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 Benesch, chief financial officer. Joining for the Q&A portion of the call will be Ramzi Aloush, 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 files 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 the 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 Morali, Co-Founder, President, and Chief Executive Officer of Journey Medical.
Thank you, Jacqueline, 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 MROSI, 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 Cubrexa, Accutane, and Amzik and Ziltsi, 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 Ambrosie and our established dermatology commercial infrastructure. We believe that this leverage will continue to increase as Ambrosie'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. Ambrosie 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 three major GPOs, Ascent, MSR, and Zinc. and we have been very successful in the first phase of our pay strategy. As we previously announced in July, over 100 million of the 187 million commercial lives currently have access to Amrosi. Our market access team has successfully contracted with two of the three largest GPOs, and as we continue to pursue our strategy to broaden access further, We believe that contracting with the remaining GPO for Ambrosie 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 three-quarters on average once contracts are secured, which is standard for most drug launches. While some plans have immediately begun covering ambrosia prescriptions, many will take time to implement coverage and formulary adoption. In the interim, our patient copay assistance program is bridging the gap. As time progresses and as drug coverage increases, we expect reliance on our copay assistance program to decrease. Physician feedback, which has been a key driver in Ambrosie's strong initial launch, continues to be very positive, with prescribers noting that their patients are doing exceptionally well on treatment. The feedback emphasizes Ambrosie's clinical benefits, notably that Ambrosie's early onset of efficacy in as little as two weeks of therapy. In line with this feedback, initial refill rates for MROSI have come in strong. During the third quarter, refills and new MROSI prescriptions were tracking at a one-to-one ratio. We believe that this metric indicates both prescriber and patient willingness not only to try MROSI, but also to continue on therapy beyond an initial prescription. In addition to anticipated continued growth and 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 Amrosi 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 Amrosi prescribers. demonstrating substantial progress toward this objective and a key driver of initial product adoption. As our commercial team continues to recruit new MROSI writers, we have now begun to focus on developing the base of prescribers that have already written an MROSI 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 Ambrosie brand. To illustrate, we present the data from Ambrosie's Phase III clinical trials at the SDPA 2025 Summer Dermatology Conference in June of this year. These data highlighted that MROSI provides consistent relief of key rosacea symptoms with no adjustments needed for patients based on body weight. Additionally, MROSI'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 MROS-C 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 Ambrosie's favorable safety profile results and superior efficacy compared to Aurasia, 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 Aurasia 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 Amrosi's podium presentation gained significant visibility at the conference. Reflecting on the year so far, Amrosi 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 MROSI 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.
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