Novan, Inc.

Hello, and welcome to the Novant Incorporated quarterly update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star then 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 risk and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and 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 but such forward-looking statements are discussed in the periodic reports NOVAN files with the Securities and Exchange Commission. These documents are made available in the investor 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 is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified, and any information obtained from third-party sources. Joining us on today's call is the Novant Leadership Team, Ms. Paula Brown-Stafford, Chairman, President, and Chief Executive Officer, Mr. John Gay, Chief Financial Officer, and Mr. Don Ofrio, Chief Operating Officer of Novant and President of EPI Health. I would now like to turn the call over to Ms. Paula Brown-Stafford. Please go ahead.

Thank you, Chuck. Thank you, Chuck. Good morning, everyone, and thank you for joining our corporate update, including Novant's financial results for the third quarter and year to date. The Novant team remains focused and passionate towards achieving our goals for 2022, and I am very proud of our many accomplishments so far this year. As a reminder, on March 11th, we announced that Novant had closed on our acquisition of EPI Health, providing Novan with commercial infrastructure and commercial revenue. We expanded the depth and breadth of the Novan opportunity to our stakeholders. We have created a medical dermatology company that has the capabilities to discover, develop, and commercialize innovative therapies, bringing medications to patients with diseases of the skin. We have made solid progress since July and have great momentum and focus going into the remaining weeks of 2022. We're pleased to share that we are tracking toward our target submission date, potentially the first FDA-approved treatment for molluscum contagiosum. We are very proud that in the third quarter, the results from our pivotal phase three study, B-simple 4, were published in the JAMA Dermatology Journal authored by Dr. John Browning and others. Also last quarter, we paid off the $16.5 million promissory note with EPG ahead of plan, saving the company nearly $11 million of future expense and no securitization of the company's marketed assets. We've delivered strong volume growth year over year for our promoted prescription products, with total revenue of over $5 million in the third quarter, results for which we are very pleased. And finally, we entered into a non-binding memorandum of understanding with Sato Pharmaceuticals on Friday to potentially market Rofate in Japan and other Asia Pacific territories, representing an important milestone in the execution of our business development strategy. We're driving the company forward. with our development and commercial achievements. Our lead product candidate is Berdasmagel 10.3% or SB206, a potential topical prescription treatment and likely the first FDA approved treatment for molluscum contagiosum. We are progressing our NDA submission for SB206 as planned. We have completed our drug product stability testing necessary for the NDA submission. We are now awaiting our drug substance stability testing and other ongoing analytical testing results. We're targeting the submission of our NDA around the end of 2022, plus or minus a week or so. Just giving ourselves a little room there. Slide seven provides our anticipated timeline based on typical regulatory schedules. So once we submit our NDA, we will await the FDA review of our submission, which is usually approximately 75 days. There, the FDA is filing of our submission while providing a PDUFA date if it is accepted. So a likely PDUFA date is 12 months from our submission date. So during 2023, we anticipate a typical FDA drug review process, and we plan to execute on our pre-launch activities and prepare supply of drug product. And if approved around the end of 2023, we could then commercially launch Ferdasmagel 10.3% in the first half of 2024. As we prepare for our potential launch of Berdasmagel 10.3% for molluscum, we have sponsored a series of market research activities to best prepare for our potential market entry. We have four primary audiences, dermatologists, pediatricians, payers, and the patients, caregivers, and families. With respect to the latter, the majority of patients with molluscum are children, primarily 1 to 14 years of age. So in a recent digital ethnography research study, more than a dozen research participants with molluscum contagiosum were each followed for up to three months. We learned of the negative impacts on the daily lives of sufferers of molluscum. Physical, functional, emotional, social, and on self identity. Physical damage and mental damage can be an outcome of molluscum and or today's molluscum treatments.

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