Novan, Inc.

Hello, and welcome to the Novant, Inc. quarterly update conference call and webcast. As a reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request. and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risks and uncertainties. Forward-looking statements on this call are made pursuant to the Safe Harbor provisions of the federal securities laws and are based on Novant's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements. Some of the factors that could cause actual results to differ materially from these contemplated by such forward-looking statements are discussed in the periodic reports Novant files with the Securities and Exchange Commission. These documents are available in the Investors section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies, publications, surveys, and other data obtained from third-party sources and the company's own estimates and research. While the company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified any information obtained from third-party sources. Joining us on today's call from the Novant leadership team are Paula Brown-Stafford, Chairman, President, and Chief Executive Officer, John A. D'Onofrio, Executive Vice President and Chief Operating Officer, and John M. Gay, Chief Financial Officer. I would now like to turn the call over to Paula Brown-Stafford. Please proceed.

Thank you, Andrew. And thanks to everyone for joining us this morning. Novan is building a premier medical dermatology company that is focused on developing and commercializing innovative therapies for diseases of the skin. Our priority is our NDA for Berdasmagel 10.3% for the treatment of molluscum, molluscum contagiosum. It is under review at the FDA with a PDUFA goal date of the 5th of January, 2024. We are in the review cycle, and we have less than eight months remaining. Since January, we have had a number of noteworthy accomplishments. Our entire team remains excited about our progress, our momentum, and what lies ahead. Our NDA was submitted in early January. This represents the most significant milestone NoVAN has achieved to date and something of which we are extremely proud. In March, our filing was accepted for review with no known potential issues. And we were provided our PDUFA goal date, as I mentioned, as well as other expected milestone dates for a standard review cycle. We continue our dialogue with the agency while we move forward with preparing toward our commercial supply of drug substance in anticipation of a potential approval. Ferdazomer gel, 10.3%, is a novel topical nitric oxide releasing medication for viral skin infections. Ferdazomer sodium, our active pharmaceutical ingredient, is a new chemical entity. Our NDA is based on a Phase III program that demonstrated clinical evidence of efficacy with robust clinical data from our B-simple-IV trial and a favorable safety profile for patients with molluscum. Our clinical trial data from B-simple-IV were published in JAMA Dermatology in July of last year. So if approved, this product would satisfy an important patient care need largely displacing in-office procedures that are often cumbersome, painful, and time-consuming. Molluscum is highly contagious. It is one of the five most prevalent skin diseases worldwide and the third most common viral skin infection in children, most of them less than 10 years old. And if left untreated, it could last up to 48 months. Through recent market research, we received caregiver feedback that speaks to the impact of the disease, really on the psyche of the patient. And to give you a sense of the real-world experiences, as you can see in these quotes here, it leaves children feeling depressed, hopeless. bullied, a need to build their self-confidence. And last week, we actually received an email from a parent. We get these quite frequently. And this one, it was just a striking email. And at the end, it said, I am looking for a sign of hope. We think we're that sign. The market is prime. for a topical self-administered or caregiver-administered therapy. The market potential is large with 6 million patients in the U.S. today and approximately 1 million new patients annually. We believe the lack of at-home options results in many undiagnosed cases. The current standard of care is in-office procedures, freezing, cutting, blistering, And off-label and OTC offerings that have no proven efficacy. Per U.S. claims data, over 70% of patients with molluscum go untreated. 19% of molluscum patients seek treatment from a dermatologist. 72% visit their pediatrician. But approximately 90% of these pediatricians have a wait and see approach. Whereas 65% of dermatologists will treat molluscum, but it's typically with a treatment that's an in-office procedure.

So this is how we view the future.