Journey Medical Corporation

Ladies and gentlemen, thank you for standing by. Good afternoon and welcome to the Journey Medical's third quarter 2022 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. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. 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 now like to turn the conference call over to Matt Blasey of CoreID. the company's investor relations firm. Please go ahead.

Good afternoon, and thank you for participating in today's conference call. Joining me from Journey Medical Corporation's leadership team are Claude Murawi, co-founder, president and chief executive officer, Ernie DiPalantonio, chief financial officer, Ramzi Aloush, general counsel, and Dr. Srini Sidgidi, VP of clinical development and medical affairs, who will be joining us for the Q&A session. During this call, management will be making forward-looking statements, including statements that address Journey Medical's expectations for future performance or operational results. 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, November 10th, 2022. 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 Merawi, co-founder, president, and chief executive officer of Journey Medical. Thank you.

Thanks, Matt. Good afternoon, and thanks to everyone for joining our third quarter of 2022 conference call. While third quarter financial results did not meet our expectations, we continue to report record revenues for the nine months ended September 30th, 2022 of 57.7 million, which is 26% greater than revenues for the nine months ended of the prior year of 45.1 million. Third quarter revenue was $16.1 million, which was $3.5 million less than the third quarter of 2021. In addition to the macroeconomic challenges faced by our sector, which limited our growth in the third quarter, TargetOx revenue for the quarter was $4 million less when compared against third quarter of the prior year. reflecting the continued impact of generic competition for the brand. However, this shortfall was partially offset by an increase in Accutane revenue of 0.6 million, or a 17% increase versus the third quarter of the prior year. Our flagship products, Cubrexa and Accutane, along with the contributions of our newly launched products, Amzik and Ziltsi, represented $44.4 million, or 81% of our year-to-date revenue. On the product development front, we are pleased to have enrolled 75% of patients throughout the U.S. and Europe in our two Phase III clinical studies, MVOR1 and MVOR2, for our DFD29 product candidate that is being evaluated for the treatment of papulopustular rosacea in adults. We anticipate completing enrollment by year's end and expect to announce top line data from the clinical trials in the first half of 2023 with an expected NDA filing in the second half of 2023. To reiterate, the market opportunity for DFD29 is significant. with an estimated 16 million people in the United States suffering from rosacea. This equates to an estimated 1 billion plus in prescription sales in 2021, according to Symphony data. The phase two clinical trial results for DFD29 demonstrated nearly double the efficacy overall ratio the current market leader and standard of care with respect to both co-primary endpoints in the study, which were, one, reduction in total inflammatory lesion count, and two, IgA success. Oracia had approximately 340 million in prescription sales in 2021, according to Symphony data. Once approved and launched in 2024, We believe that DFD29 will be able to achieve net sales in excess of $100 million annually, providing meaningful revenue contribution for the company. To provide context of the expected revenue contribution of DFD29, our total revenue for fiscal year 2021 was $63.1 million. We believe that the commercial opportunity for DFD29 and the near-term launch of our anti-itch product, together with our robust portfolio of prescription dermatology products, positions Journey Medical for continued growth in the future. Further strengthening our ability to achieve continued growth and expanding our runway to do so are our successful three paragraph four litigation settlements with Patagas, which resulted in the following. Cubrexa with an entry date no earlier than August 15th, 2030. Amzeek with an entry date no earlier than July 1st, 2031. And Zilksi with an entry date no earlier than April 1st, 2027. With the continued expected growth of our newly launched products, the expected launch of our anti-itch product, and our ability to maximize internal efficiencies, we expect our commercial operations to return to profitability. Our strategic focus on the continued expansion of our product portfolio through in-licensing, acquisition, and developing novel dermatology products and future product candidates, combined with our industry-leading sales force, continues to be the cornerstone of our future growth. With that, I'll now turn the call over to Ernie DePalantonio, our CFO, who will review our financial results for the third quarter.