VYNE Therapeutics Inc.

to the Vine Therapeutics Third Quarter 2020 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Michael Wood, LifeSci Advisors. Please go ahead, sir.

Thank you. Good morning, everyone, and thank you for joining us this morning. Before we begin the formal remarks, let me remind you that some of the information in the press release that was issued by the company this morning and on this conference call contain forward-looking statements that involve risks, uncertainties, and assumptions. that are difficult to predict. Words that express and reflect optimism, satisfaction with current progress, prospects and 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 include are described in detail in the company's filings with the SEC. These forward-looking statements speak only as of today to 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. The company has provided a reconciliation for such numbers in the earnings release. Participating in this morning's call are Dave Domzalski, Chief Executive Officer of Vine Therapeutics, Andrew Sake, Chief Financial Officer, and Matt Wiley, Chief Commercial Officer. 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. This is our first quarterly call since we announced our rebranding to Vine Therapeutics in September, with the corresponding update of our ticker symbol to VINE. Having achieved FDA approval for our two commercial products, Amzeek and Zilxy, we thought that this was a good opportunity to take a look at our corporate branding and make sure this was aligned with our vision and the positive image we wanted to project to our customers and various stakeholders. The symbolic meaning behind our new name reflects our core values, strength, growth, endurance, and resilience, and is a testament also to the value of our proprietary technology. We are excited to have launched Zilxy on October 1st, which is our 1.5% minocycline topical foam for the treatment of inflammatory lesions of rosacea in adults. We received FDA approval for Zilxy in May, and this is, in fact, the first minocycline product in any form to be approved for use in rosacea. Our immediate priorities for Zilxy are to leverage physician experience with ANSI as well as our MST technology in order to drive rapid trial and experience with Zilksy and to gain broad payer acceptance and reimbursement. We already made progress right out of the gate on the payer front with the signing of a contract with Express Scripts just after launch. Matt Wiley will expand on this. The organization market remains an area of significant unmet medical need, and we believe that Zilksy should receive broad market acceptance. Within just a few weeks of launch, we are already seeing excitement from healthcare providers relating to the availability of Zilce as a new treatment option for patients. Turning now to Amzeek, the overall blended acne market continues to recover and prescription counts for Amzeek continue to grow. I'm pleased to report that both weekly and monthly prescriptions have now eclipsed pre-COVID levels for the first time since the shutdown in March, and then we are gaining market share. we continue to see both interest and enthusiasm among healthcare providers as trial and utilization of Amzeek continues to increase. Also on October 1st, we hosted a physician symposium for investors featuring three dermatologists, which highlighted the way in which these doctors are currently using Amzeek and how they plan to use Zilxie in their practices. They shared that they were pleased with the performance of Amzeek in their patients and expect continued broad utilization of Amzeek in acne. We were also delighted to hear that these doctors believe that Ziltsy could become their first-line therapy fluorization. If you missed the event, a replay can be found on our website at bindtherapeutics.com under the Investor section. So if it goes to the Events and Presentations section, click on the Investor Event Physician Symposium dated October 1, 2020. Fill out the registration form, and you can view the replay. Regarding FCB 105, which is our investigational combination minocycline and adapalene foam for moderate severe acne, we will have our end-of-Phase II meeting with the FDA this quarter and intend to share our Phase II data along with our plans for our Phase III development program. Recall that in June, we announced positive results in the 447-patient Phase II trial, showing potentially best-in-class improvements, on both IGA treatment success score and inflammatory lesion counts. Finally, in September, we announced the appointment of Patrick Lepore to our board of directors. Pat has an extensive record of creating shareholder value both organically and through strategic M&A as a board member and a former CEO of several life science companies. We're thrilled to have Pat on our board. His experience will be enormously helpful as we continue to execute on the launch of our commercial products and grow our business. With that, let me now turn the call over to Matt Wiley, our Chief Commercial Officer, who will provide an update on our commercial activities. Thanks, Dave. We are pleased with the commercial execution for both Amzeek and the recent launch of Pillsy into the rosacea market. Although the pandemic has had impact on both the acne market and physician access for our sales team, I'm encouraged by the resilience and fortitude of our team to continue to sell through these obstacles. AMZ prescription volume in the third quarter came in at 26,900 NRXs and 32,700 TRXs, representing 49% and 52% growth over Q2, respectively. Additionally, in our most recent weekly data, ending the week of October 23rd, we equipped 3,500 TRXs for the first time. We continue to expand our reach and trial of Amzeek with a number of unique prescribers exceeding 5,500 through Q3, representing a 31% increase over the previous quarter. Additionally, since launch, we've educated approximately 1,300 healthcare providers on the features and benefits of Amzeek through virtual and live speaker programs with the ambition of educating over 2,000 healthcare practitioners total in 2020. With respect to market access, our coverage for AMZIC has increased to 67% of total commercial covered lives, with one major PBM negotiation in process. Our goal is to complete negotiations before the end of the year, which would take our covered commercial lives to over 80%, which has been our target. Turning to ZILTI, the Rosacea brand of prescription market appears to have largely recovered from COVID-19 impact. Zilci was launched on October 1st with over 7,500 calls made to date. We've already reached 55% of our Zilci target universe and educated over 500 healthcare providers through peer-to-peer programs in the month of October. Conversations with payers on Zilci continue to be encouraging, with payers expressing strong interest in the brand and acknowledging a significant unmet need in the rosacea population. Express Scripts, one of the nation's leading PBMs, made the decision to cover Zildjie effective October 2, 2020, on its national preferred flex and basic commercial formularies. This is an important step towards broad pair coverage as it represents millions of additional covered lives in the U.S. that follow these formularies. With this successful contract execution, we now have just over 50% of commercial lives covered across the country. We expect additional PPM contracts to execute over the next few months. I will now turn the call over to Andrew, who will provide the financial update.