VYNE Therapeutics Inc.

Welcome to the Vine Therapeutics conference call to discuss the first quarter 2021 financial results and updates. At this time, all participants are in a listen-only mode. Following the company's formal remarks, we will open the call for your questions. Please be advised that this call is being recorded at the company's request. I will now turn the call over to Michael Wood at LifeSci Advisors. Please go ahead.

Good morning, everyone, and thank you for joining us. Before we begin formal remarks, let me remind everyone you that some of the information in the press release issued this morning and on this conference call contained forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict, including statements, forecasts, and observations regarding future financial operating performance, impacts of the COVID-19 pandemic online, and observations regarding ongoing operating expenses and net revenue. These statements include observations associated with commercialization of Amnesty Consultancy in the United States. It will also include plans and expectations regarding the success, timing, and cost of clinical trials. Words that expect and reflect optimism, satisfaction with current progress, prospects or projections, as well as words such as believe, intend, expect, plan, anticipate, and similar variations identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Such forward-looking statements are not a guarantee of performance, and the company's actual results could differ materially from those contained in such statements. Several factors that could cause or contribute to such differences are described in detail in Vine Therapeutics' filings with the SEC. These forward-looking statements speak only as of the date of today's press release and conference call, and the company undertakes no obligation to publicly update any forward-looking statements or supply new information regarding the circumstances after the date of this call. In addition, the financial portion of the call will include certain non-GAAP financial information. For additional disclosures relating to these non-GAAP financial measures, including a reconciliation to the most directly comparable GAAP measures, please see today's press release, which is posted on the Investor Relations section of the company's website. Participating in this morning's call are Dave Domzalski, Vines President and Chief Executive Officer, Andrew Saik, Vines Chief Financial Officer, Matt Wiley, Vines Chief Commercial Officer. In addition, Dr. Ian Stewart, the company's Chief Scientific Officer, is also on the line and will be available during the Q&A sessions. At this time, I'd like to turn the call over to Dave Domzalski. Dave, please go ahead.

Thank you, Michael, and good morning to everyone. I'd like to talk about our recent progress and plans for 2021. As we continue to build the business, we are focused on three key areas. The first is commercial execution, where our top priority is to expand initial trial of Amzeek and Ziltsi and grow continued utilization of our products. Matt Wiley, our Chief Commercial Officer, will provide an update on our two lead assets. The second is maximizing operational leverage. We are in a position to take advantage of the significant overlap that exists between acne and rosacea prescribers as we deploy our sales organization efficiently. There will be opportunities to leverage this even further as we continue to add additional products over time. In parallel, We will prioritize our resources prudently and keep a tight control of expenses. At Andrew's sake, our CFO will provide a financial update. The third is building a diversified portfolio and pipeline. During Q1, we unveiled our newest therapeutic candidate, FMX114, which is a fixed combination of topazidinib, a Pan-JAK inhibitor, and Fingolimod, a sphingosine-1 phosphate receptor modulator, an atopical gel that is being developed for the treatment of mild to moderate atopic dermatitis. Preparation activities for our upcoming Phase IIa study are ongoing, and we plan to initiate this study in the third quarter and anticipate top-line results before the end of this year. FCD-105, which is our minocycline and adapalene combination product candidate for the treatment of moderate to severe acne, is now Phase III ready. We continue to be prudent as to when we would commence a Phase III program for FCD-105. This will largely hinge on our results of operations and market conditions, which depend on numerous factors, including the impact of the COVID-19 pandemic, recent payer formulary decisions, and our ability to successfully enroll patients in Phase III studies. With our focused efforts on the introduction of Amzeek for the treatment of acne, as well as our recent launch of Zilxy for rosacea, Our prioritization of resources should remain on these two assets within our acne and rosacea franchise until we believe the environment is optimal to progress the phase three studies for our next product in acne, FCD105. As we broaden our pipeline beyond acne and rosacea, advancing FMX114 into the clinic next quarter is both an important strategic step for our company and also a judicious deployment of our R&D resources. Let me review the highlights for the quarter. Beginning with FMX114, we created this investigational combination product to address the multifactorial nature of atopic dermatitis and to target both the source and cause of inflammation. Topacitinib reduces inflammation by inhibiting cytokine release from inflammatory cells, and Fingolimod inhibits the migration of inflammatory cells, as well as potentially supporting skin barrier recovery an important factor for patients afflicted with this inflammatory skin disorder. On our year end 2020 call in March, Dr. Ian Stewart presented compelling preclinical proof of concept data for FMX114. We now plan to initiate a phase 2A proof of concept study in this third quarter coming up and anticipate top line results prior to the end of this year. Atopic dermatitis represents a large market opportunity. with an estimated 30 million patients diagnosed in the U.S. Of these, 22 million are classified as mild to moderate and are on treatment. Topical steroids account for 8 out of 10 of the most prescribed products, but are associated with negative effects on the endocrine system and skin structure when used for a prolonged period of time. So there clearly is a need for an alternative that can address the underlying disease pathogenesis, and most importantly, is safe enough for patients to apply chronically. We look forward to providing further updates on FMX 114 this year as the product advances. Regarding our commercial business, we generated a revenue of 4.1 million in the first quarter of 2021 compared to 1.8 million in the first quarter of 2020. We now have further clarity on market access and now anticipate AMSEC and Zilksy market access to be in the range of 70 to 75% of commercial lives for the balance of this year, as Matt Wiley will discuss further. We also ended the quarter with $120.4 million in cash. I will now turn the call over to Matt Wiley, who will talk about our progress on the commercial front. Matt.