Fortress Biotech, Inc.

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to Journey Medical's 2024 Financial Results and Corporate Update Conference Call. 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 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.

Good afternoon. And thank you for participating in today's conference call. Joining me from Journey Medical's leadership team are Claude Marawi, 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, general counsel and corporate secretary, 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 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, March 26, 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 Clyde Morali, co-founder, president, and chief executive officer of Journey Medical.

Thank you, Jacqueline, and good afternoon to everyone on the call today. 2024 was a pivotal year for Journey Medical. as we delivered on all of our guidance ranges for the year and positioned the company to launch MROSI, our best-in-class oral treatment for rosacea. We reported annual revenue of $56 million in 2024, and the fourth quarter marked the sixth consecutive quarter that the company achieved positive non-gap adjusted EBITDA. Additionally, we submitted our new drug application for Ambrosie in early 2024 and received an on-time first cycle approval from the FDA in November. In 2024, we also paid out a total of $22 million in FDA filing fees and milestone payments to Dr. Reddy Labs. These one-time payments completed our financial obligations associated with Ambrosie's regulatory fees and development milestones in the United States for the rosacea indication. As a result, this clears the way for Ambrosie's commercial debut and our ability to increase our product revenues and operating cash flow as the product gains traction in the market. Despite these payments, our balance sheet remains strong ahead of the MROSI launch with $20.3 million in cash as of December 31st. We believe that Journey is well positioned ahead of the MROSI launch, given that our current commercial organization is already targeting the same dermatology prescribers that treat the vast majority of rosacea patients. This means that MROSI sales have potential to generate significant operating leverage for the business. Given the market opportunity for MROSI, which is entering a billion-dollar-plus treatment category with superior Phase III clinical results against the current oral standard of care, we believe that the product can be transformational to our business. Other accomplishments in 2024 include presentations of MROSI clinical data at key medical congresses, such as the American Academy of Dermatology Annual Conference in March, the Dermatologic Education Foundation Nurse Practitioner and Physician Assistant Conference in July, and the Fall Clinical Dermatology Conference in October. And in November 2024, our licensed partner, Cutia Therapeutics, received regulatory approval to market Amzeek in China, which triggered a $1 million milestone payment to Journey. Continuing the business momentum from last year, 2025 is off to a strong start. Earlier this month, we hosted an exhibit booth at the 2025 AAD conference in Orlando, Florida. The AAD meeting attracts more than 20,000 attendees, including top dermatology KOLs and high prescribing physicians, nurse practitioners, and physician assistants. Our exhibit booth at the conference was very productive in terms of foot traffic, and the time that attendees spent in our exhibit to learn about Ambrosie's recent FDA approval and our superior head-to-head Phase III results against aurasia. Notably, dermatologists were interested in Ambrosie's low-dose modified release formulation comprised of 10-milligram immediate release and 30 milligrams of extended release minocyclines. as well as the product's favorable safety and tolerability profile. We also observed significant attendee interest in the before and after photos of patients in our Phase III clinical trials, which were a focal point in our exhibit. Many dermatologists already know Journey, our current products, and the strong customer service that we provide including our co-pay assistance and access programs. We believe that the AAD meeting was highly successful and generated significant customer interest heading into the MROSI launch. Our national sales meeting kicks off next week, and with our launch quantities in place, we recently began shipping MROSI inventory into the distribution channel and have already begun seeing prescriptions dispensed. As a result, we are well prepared to execute on a robust launch in early April. On our pre-commercial update call in February, we noted approximately 12% commercial payer coverage for Amrosi at the time. Due to our initial market access efforts, which began immediately after Ambrosie's FDA approval last November. As an update, we now have coverage of approximately 20% of the 188 million commercial lives and 4% of the 58 million Medicare lives, enabling those patients access to Ambrosie through their health insurance plans. We expect the number of payers and covered lives to increase substantially throughout the remainder of this year and into 2026. So far, we believe that the early progress is promising, and we expect to report on the ramp up in payer coverage throughout the year. Earlier this month, our phase three results from MBROSI were published in a peer-reviewed article in the Journal of the American Medical Association, or JAMA, Dermatology, one of the most well-recognized journals in medicine. Notably, this journal has among the highest impact factors in the dermatology field. The paper focused on the head-to-head clinical superiority of ambrosia on both of our co-primary endpoints against aurasia and placebo, with very high statistical significance. As well, the publication noted that Ambrosie's Phase III results met all of the secondary endpoints, including a statistically significant benefit in reducing erythema or the redness associated with rosacea compared to placebo. The publication also noted the favorable safety profile of Ambrosie. We believe that the JAMA publication is a significant positive that coincides well with our launch and can create additional awareness of Ambrosie's benefits as we roll the drug out into the market. In addition to the JAMA article, we anticipate two more publications on Ambrosie this year, with one focusing on the microbiology study that we conducted. which demonstrates the drug's sub-antimicrobial effects, and the other on the quality of life improvement for patients taking Ambrosie to treat their rosacea symptoms. As well, Journey is planning to attend, exhibit, and present at additional dermatology-focused medical congresses throughout 2025. With that, I will now turn the call over to our CFO, Joe Benesch, to review our financial results for 2024. Thank you, Claude.