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?