VYNE Therapeutics Inc.

Good morning, and welcome to the Vine Therapeutics conference call to discuss the fourth quarter and full year 2020 financial results and update. 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 this morning. Before we begin with formal remarks, let me remind you that some of the information in the press release issued this morning and on this conference call contain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict, including statements, forecasts, and observations regarding future financial and operating performance, impacts of the COVID-19 pandemic on buying, and observations regarding ongoing operating expenses and net revenue. These statements will include observations associated with the commercialization of advocacy consultancy in the United States. They will also include plans and expectations regarding the success, timing, and cost of clinical trials. Words that express and reflect optimism, satisfaction with current progress, prospects and rejections, 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 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 this call will include certain non-GAAP financial information. For additional disclosures regarding to these non-GAAP financial measures, including a reconciliation of 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 Sake, Chief Financial Officer, Dr. Ian Stewart, Chief Scientific Officer, and Mark Wiley, the company's Chief Commercial Officer. Please note that following the company's prepared remarks on the 2020 financial and operating results, Dr. Stewart will be reviewing the company's pipeline candidate, FMX114. His review includes a number of slides via the webcast, and these are posted on the Investor Relations section of the company's website. At this time, I'd like to turn the call over to Dave Zamzowski. Dave, please go ahead.

Thank you, Michael, and good morning to everyone. The past few months have been productive for Vine, and we believe the company is well positioned to deliver value to our shareholders as we continue to execute on our vision. As we think about our key objectives for the year, there are three areas of focus. First is commercial execution. The past year has certainly posed challenges that have never been seen before in the commercialization of therapeutics. and has been even more challenging for new product launches as companies have faced continued shutdowns and customer access issues globally. As discussed in past calls, we have faced and continue to address these challenges head on. Despite the headwinds, we continue to progress trial and utilization of AMSEC and Zilxy, driving market share in their respective markets of acne and rosacea. Matt Wiley, our Chief Commercial Officer, will provide a more detailed update on both product launches. The second is maximizing our operational leverage. The significant overlap that exists between prescribers for acne and rosacea is a key factor in our commercial strategy. And as we add new products in the future, there will be further opportunities to leverage both our sales organization and R&D capabilities to increase revenue and earnings. Importantly, we will continue to prioritize our resources carefully and keep a tight control of expenses. Andrew Sake, our CFO, will provide a financial update today for you. Our third area of focus is to continue to build a diversified pipeline. For FCD105, which is our minocycline and adapalene combination, we held a successful end of phase two meeting with the FDA in November. The meeting provided clear direction and guidance on the planned Phase III clinical and pharmaceutical development for FCD-105, and we anticipate initiating this study later this year. Earlier this week, we unveiled a new therapeutic candidate that we believe has tremendous value. This product candidate, which we refer to as FMX-114, is a fixed combination of the Pan-JAK inhibitor topacitinib, and a sphingosine 1-phosphate receptor modulator, Fingolimod, in a topical gel formulation for the treatment of mild to moderate atopic dermatitis. We believe this has the potential to be the first topical combination JAK inhibitor. Atopic dermatitis is a substantial market opportunity with approximately 22 million patients treated in the United States alone. We issued a press release on Monday highlighting the preclinical efficacy and tolerability data. Our Chief Scientific Officer, Dr. Ian Stewart, is joining our call this morning to provide an overview of FMX 114. Ian will walk you through the data and discuss the Phase 2a program NAD that we plan to initiate in the third quarter of this year and from which we would anticipate generating top line results prior to year end. 2021 has been busy. We executed new PBM contracts for both Amzeek and Zilxy in mid-January. The completion of these agreements is consistent with our goals to achieve broad commercial coverage of Amzeek and Zilxy. It gives us commercial access to an additional 20 to 25 million new lives. For Amzeek, we received FDA approval to include new information in the product label referencing the low propensity of P. acnes strains to develop resistance to minocyclin. which is the active ingredient in AMZEQ. This label update can provide further product differentiation for AMZEQ, which will be useful to healthcare providers in their treatment selection for patients. Additionally, we strengthened our balance sheet, raising a combined $81 million in net proceeds from mid-fourth quarter last year through January of this year. Approximately $46.7 million of this was through a registered direct offering with high-quality investors, and $34.3 million of net proceeds were generated from the sale of common stock through our ATM facility, which is now complete and terminated. In addition to the company's existing cash and investments as of December 31, 2020, and projected cash flows from revenues, We now expect to have sufficient cash to fund our operating expense and capital requirements through the end of 2022. And finally, we executed a one for four reverse stock split on February 12th. We had a large number of shares outstanding following the merger last year, which we felt was disproportionate to the market cap and underlying value of the company. Our shareholders approved the reverse split, And we look forward to unlocking shareholder value and continuing to drive additional visibility among the important strategics and shareholders in our universe. I will now turn the call over to Matt Wiley. He will give further insight regarding our progress on the commercial front. Matt.