Journey Medical Corporation

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to Journey Medical's second quarter 2023 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 the call will be available approximately one hour after the end of the call for approximately 30 days. I would like now to turn the call over to Mr. Matt Blasey of Core IR, the company's investor relations firm. Please go ahead, sir.

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team are Claude Morawi, co-founder, president, and chief executive officer, Joe Benesch, Interim Chief Financial Officer, Dr. Srini Sidgiti, Vice President Research and Development, and joining us for the Q&A session will be Dr. Neil Bhatia, Director of Clinical Dermatology at Therapeutics Clinical Research. 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 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 companies 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, August 8th, 2023. 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 Mrawi, co-founder, president, and chief executive officer of Journey Medical.

Thanks, Matt. Good afternoon, and thanks to everyone for joining our second quarter 2023 conference call and corporate update. This is an exciting time for Journey Medical. Our commercial business has seen a strong rebound this quarter. And as we recently announced, our phase three trials for DFD29 treatment for rosacea achieved the co-primary and all secondary endpoints with no significant safety issues. I will begin by making some brief comments on the clinical trials and will then be joined by our Vice President of Research and Development, Dr. Srini Sigidi. who will present this clinical data in greater detail. Immediately following the presentation, we will review our second quarter results and open the line for questions. For the benefit of those on the call who are following our slides, please note that those slides will only be used in the section of the call where Dr. Sigity is reviewing the data from the Phase III trials. We are very pleased with the positive results of our two Phase III clinical trials evaluating DFD29 for the treatment of rosacea, which demonstrated statistical superiority over both aurasia and placebo. This is a significant milestone for Journey Medical and potentially the broader dermatology community. There were approximately 4 million prescriptions written for rosacea in 2022, according to Symphony Health prescription data. Based on these positive study results, we plan on submitting a new drug application for DFD29 in the second half of 2023. If approved by the FDA, we believe that DFD29 has annual peak sales potential of $300 million globally. With these clinically meaningful outcomes, DFD29 has the potential to become the new treatment paradigm for the millions of patients suffering from rosacea as the lowest dose oral minocycline on the market. The success of the program is a direct result of the exceptional collaboration between Journey Medical Dr. Reddy's, the investigators, and all the others that have been involved. We believe the potential approval of DFD 29 will be a transformational event for Journey. At this point, I would like to turn the call over to Dr. Sigity to discuss the results of the Phase III data in more detail. I will follow up to discuss this market opportunity and our strategy on becoming the market leader in this space.