Hello, and Welcome to the Novan, Inc 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 would 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 Novan'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. 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 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 is 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 is the Novan leadership team, Ms. Paula Brown Stafford, Chairman, President, and Chief Executive Officer, Mr. John Gay, Chief Financial Officer, and Mr. John Donofrio, Chief Operating Officer of Novan 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. Good morning, everyone, and thank you for joining our corporate update, including Novan's financial results for the third quarter and year-to-date. The Novan 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 11, we announced that Novan 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 III study, B-SIMPLE4, were published in JAMA Dermatology, authored by Dr. John Browning and others. Also last quarter, we paid off the $16.5 million promissory note with EPI Health 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. Finally, we entered into a non-binding memorandum of understanding with SATO Pharmaceutical on Friday to potentially market RHOFADE 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 Berdazimer Gel, 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 pro-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 ±, a week or so. Just giving ourselves a little room there. Slide seven provides our anticipated timeline based on typical regulatory schedules. Once we submit our NDA, we will await the FDA review of our submission, which is usually approximately 75 days. Then, the FDA's filing of our submission, while providing a PDUFA date if it is accepted. A likely PDUFA date is 12 months from our submission date. 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. If approved around the end of 2023, we could then commercially launch Berdazimer Gel 10.3% in the first half of 2024. As we prepare for our potential launch of Berdazimer Gel 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. In a recent digital ethnography research study, more than a dozen research participants with Molluscum contagiosum were each followed for up to 3 months. We learned of the negative impact 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. Through a survey of 142 healthcare practitioners or HCPs, we validated that there is an unmet need for Molluscum treatments. We surveyed pediatricians, dermatologists, pediatric dermatologists, nurse practitioners, and physician assistants. The majority of those surveyed confirmed that there is a need for new options. The highest level of need is with pediatricians and dermatologists, and nearly all dermatologists surveyed saw a need for a treatment option. They are clearly dissatisfied with current options available. According to medical and pharmacy benefit claims data, pediatricians largely take a wait and see approach to treating Molluscum, greater than 90% of them. Less than 10% treat at all. Whereas dermatologists treat 65% of those who visit. The number of patients diagnosed by a dermatologist is approximately 25% of those diagnosed by pediatricians. When HCPs were asked to rate their willingness to prescribe a possible new topical treatment, specifically Berdazimer Gel, 10.3%, there was a high interest in such an option, and this confirmed our view that there is unmet need when it comes to Molluscum. Children, their caregivers, their families, and their healthcare providers are in need of options. Let's look at one of those potential options. We previously reported robustly positive efficacy results from our pivotal phase III study known as B-SIMPLE4, and as mentioned earlier, recently published in JAMA Dermatology. To our knowledge, B-SIMPLE4 included the largest cohort of patients with Molluscum contagiosum randomized in a controlled clinical trial. Patients were eligible to enroll as early as six months of age. A topical prescription alternative to other therapies used is desired for this highly contagious and psychosocially challenging skin condition. B-SIMPLE4 demonstrated clinical and statistical evidence of efficacy with our primary and secondary endpoints and a favorable safety profile. Now, if I look at the last audience that I discussed, payers, our team is actively strategizing regarding payers, pricing, and reimbursement. Our takeaways to date are that there is limited to no management of Molluscum. Payers may be more favorably disposed because this is a pediatric population. Most payers rated Berdazimer Gel quite highly. You'll see here 5.1 on a scale of 1 to 7. We saw that non-coverage seems unlikely. Our strategic efforts continue to make positive progress toward a responsible pricing strategy. These previous slides really are to share some of the results from our market research efforts as we plan and execute toward a potential commercial launch and launch success. We've developed an in-depth launch plan, and importantly, we have acquired our commercial infrastructure to ready ourselves for a potential launch. We've made solid initial progress in building awareness with HCPs through our medical education efforts, and we've begun to develop our pricing and reimbursement strategy. We will start to build up our commercial supply as we get closer to a potential approval. At Novan, we plan for success, and a product launch is no different. I'll now turn the call over to John Donofrio, our Chief Operating Officer and the President of EPI Health, for our commercial update. John? Thank you, Paula. Good morning, everyone. I'm pleased to report that our promoted products delivered strong year-over-year prescription growth, both year-to-date and for the third quarter. This growth is due to our continued execution of our commercial plan, strong prescriber base, and solid product portfolio. As noted in our Q2 earnings call, seasonality of the third quarter historically does not lead to quarter-over-quarter growth in some of our disease states. We saw this play out with RHOFADE and WYNZORA with a reduction in prescriptions versus previous quarter. However, and importantly, both brands maintained their writer base levels from previous quarter and continue to deliver strong growth compared to same quarter last year. An increased commercial focus on our acne brand, MINOLIRA, led to strong double-digit year-to-date growth quarter versus last year and quarter-over-quarter growth. While we don't yet provide revenue guidance, I can say that we remain confident we will finish 2022 with strong double-digit prescription growth in each brand versus 2021. I will now provide additional highlights on each of our promoted products. With RHOFADE, we continue to dominate the persistent facial erythema market, owning approximately 90% of the market. RHOFADE is fast-acting, lasts all day. Improvement persists with regular daily use over 52 weeks. Prescription volume for RHOFADE in the third quarter came in at 37,900 total prescriptions, representing a 31% growth over year-over-year and beating the total rosacea market, which grew only 7% for the same time period. In addition, the number of unique prescribers exceeded over 8,000 in Q3, demonstrating a strong base of healthcare providers who believe in the value of RHOFADE for their patients. In fact, RHOFADE increased its growth rate of new patients and new prescriptions in Q3 to 32% year-over-year, compared to 26% growth year-over-year in Q2, demonstrating the increased use of RHOFADE to treat persistent facial erythema among rosacea patients. WYNZORA, which was launched July of last year, continues to grow steadily year-over-year. We have a strong partnership and collaborations with MC2 Therapeutics for the sale and marketing of WYNZORA in the U.S. for plaque psoriasis. This is the first and only water-based combination product with the power of a high-potency steroid and the added benefits of a vitamin D analog in a cream formulation. WYNZORA has quick onset of action with visible improvement at one week, including impact on itch and is ideal for localized plaques on knees, elbows, and scalp. As we covered on our Q2 call, new competitors have launched in Q3 and have challenged the use of topical steroids for psoriasis. You can see the impact in the reduction of total prescriptions from Q2. However, WYNZORA managed to finish Q3 with no loss in market share within the topical psoriasis market. We maintained our writer base, and WYNZORA consistently gets more new patients per writer than any other branded steroid-based topical product. We are confident in the continued use of topical steroids for the treatment of plaque psoriasis going forward and the benefits that WYNZORA brings to patients who need and desire quick relief. Our growth strategy continues to focus on expanding our writer base so more patients can get the benefit of WYNZORA. MINOLIRA, an oral minocycline for the treatment of acne, offering weight-based flexible dosing and the first-ever biphasic delivery system. We have seen significant growth in prescriptions since increasing our promotional efforts on the brand this year. We delivered our largest growth in MINOLIRA prescriptions during this quarter as MINOLIRA hit another all-time high in total prescriptions, over 12,000, and grew 78% versus prior year and 23% over previous quarter. We picked up almost half a share point in a very large oral antibiotic acne market, putting MINOLIRA on a continued path for growth going forward. Overall, we are very pleased with the continued prescription growth of our promoted brands in quarter three, especially given the seasonality and significant noise of new competitors. We look to close out 2022 with the same energy, execution, and performance that we have demonstrated over the last three quarters, and we look further out with excitement of our upcoming potential launch of SB206. Thank you, and I'll hand it back over to Paula. Thank you, John. In summary, we're pleased with our commercial performance in a quarter that met our internal expectations in terms of total prescriptions. Now I am confident in our commercial team and their efforts to continue on a growth trajectory into the fourth quarter. I'll now turn the call over to John Gay, our Chief Financial Officer, to review our third quarter and year-to-date financials. John? Thank you, Paula. Good morning, everyone. This quarter represents the second quarter in which we have fully consolidated results from our commercial business. I'll remind our listeners that when I refer to year-to-date figures, this represents 203 days of commercial activities based on our March eleventh acquisition of EPI Health. Before I touch on some of the key data points for this quarter, I would like to remind our listeners that we are not yet in a position to provide guidance as it relates to full year 2022 revenues or EBITDA. However, as John noted, we see a path for continued year-over-year prescription growth in our promoted product portfolio. As of September 30, our year-to-date commercial business reported total revenues of $11.2 million. Net product sales of RHOFADE included in our commercial business's total revenue was $8.6 million, with other products in our portfolio contributing $2.6 million year to date. RHOFADE prescriptions have continued to grow with a year-over-year increase of 37% for the nine months ended, and a year-over-year increase of 31% for the three months ended September 30. We continue to see opportunity for improvement in WYNZORA, which launched in Q3 of last year. In addition, MINOLIRA prescriptions have continued to grow with a year-over-year increase of 59% for the nine months ended, and a year-over-year increase of 78% for the three months ended September 30. I will now provide a bit more detail of our Q3 financial results, which expands on the information filed this morning. Commercial product cost of goods sold was $4.3 million for the nine months ended Q3. Cost of goods includes the cost of procuring finished goods from our third-party manufacturers, in addition to sales-based royalty and milestone expenses and third-party IP licensing costs. Our R&D business incurred research and development expenses of $12.3 million for the nine months ended September 30, compared to $15.9 million in the prior year period. The decrease of $3.7 million was primarily related to the SB206 clinical program based on timing of the B-SIMPLE4 trial. On a consolidated basis, SG&A expenses were $27.2 million for the nine months ended Q3, compared to $8.1 million for the prior year period. The increase of $19.1 million was primarily due to $9.3 million of selling general and administrative expenses related to EPI Health's commercial operations, $4.8 million of transaction-related expenditures related to the EPI Health acquisition, and a $2.3 million increase in investment costs related to the SB206 pre-launch strategy and commercial preparation. For the nine months ended September 30, we had $3 million of other income, primarily related to the net impact of the settlement of the promissory note related to the EPI Health acquisition. As previously noted, in July of this year, we reached agreement with the seller in the EPI Health acquisition regarding payment and termination of the previously outstanding $16.5 million note. We achieved this termination with payment of $10 million, or an approximate 39% discount on the original principal amount of the note. In addition to saving $6.5 million of principal with this termination, we also avoid paying interest over the full term of the note of approximately $4.6 million. Removing this previously existing liability allows us to use our cash for development of our product candidates rather than debt servicing, and to support the commercialization of our products. On a consolidated basis, total revenue was $13.2 million year-to-date compared to $2.3 million for the prior year period. Total net loss was $28.3 million for year-to-date third quarter as compared to $21.5 million in the prior year. We continue to focus on optimizing our commercial business while at the same time investing in and looking forward to the potential launch of SB206. As you can see, a 40% year-over-year growth in our marketed portfolio prescriptions, excluding WYNZORA, which was launched in Q3 of last year, and Cloderm, which we are not actively marketing. This gives us confidence that we'll be able to continue the prescription growth trend for the remainder of the year. As it relates to our balance sheet, as of the end of the quarter, we had a total cash balance of $14.9 million, and accounts receivable also totaling $14.9 million. We will need additional funding to support our plan and future operating activities and our SB206 product candidate and our commercial business. We believe that our cash balance as of September 30, plus expected receipts from our commercial business, will provide us liquidity to fund our operating needs into the beginning of 2023. However, variability in our forecast, driven primarily by commercial sales, timing of certain operating expenditures, and anticipated changes in net working capital may impact this runway. We have been pursuing and will continue to pursue additional capital through a broad range of financing strategy and other strategic alternatives. As an example of potential strategic non-dilutive financing, as we noted in our filings this morning, we have entered into a non-binding memorandum of understanding with SATO for a proposed exclusive license in order to commercialize RHOFADE in Japan. Other potential funding activities may include equity financings, convertible debt, or capital from non-dilutive sources, or traditional debt financings such as term debt, revolving lines of credit, or other asset-based funding facilities. We are working vigorously towards providing the additional capital needed to continue investment in our business. Of course, we will update our shareholders and other interested parties as appropriate and as required. With that, I will turn it back to Paula. Thank you, John, for providing an update on our financial results and status. We're pleased with Novan's progress in the third quarter, and let me just summarize with the following, the good progress and, our top priorities in the fourth quarter and going into 2023. We continue to advance our efforts toward an NDA submission in 2022 or very early 2023, having our drug product stability results in-house. Yet a few moving parts towards the final dossier. We are planning for success and preparing ourselves for a potential product launch of Berdazimer Gel, 10.3% if approved. We have commercial momentum here at the front end of the fourth quarter. We continue to pursue, evaluate, and consider collaborations that could expand our existing commercial products beyond the US, and are pleased with our opportunity to finalize a license agreement with SATO Pharmaceutical to potentially market RHOFADE in Japan as well as other, Asia PAC territories. In closing, the full Novan team remains energetic, focused, and confident in our future path. We appreciate your continued support. Operator, I'm gonna now ask, and turn the call back to you to facilitate our Q&A session. Thank you. We will now begin the question-and-answer session. To ask a question, you may press star, then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. At this time, we'll pause momentarily to assemble our roster. The first question will come from Jeff Jones with Oppenheimer. Please go ahead. Good morning, guys, and thanks for taking the question. I guess a couple of things. In terms of SB206 and the language used around end of year, just wanted to confirm there's no concerns around the drug substance registration batch stability, it's just a timing issue? And then in terms of the product revenues and the slight pull down due to seasonality, is that something you continue to expect to see in Q4, or when does that begin to reverse itself? With that, I'll hop back into the queue. All right. Thank you, Jeff. I'll take the first on 206, and then I'll have John Donofrio discuss the product revenue for fourth quarter. Is it a concern or is it timing? It is the latter. It's not a concern, it is the timing of getting those stability testing and other analytical testing that we're doing, getting those results. Most of it is with third parties, and we are partnering, and we don't have a concern with the timing. I just wanna give ourselves some room if we don't get it at the expected time to be able to put it in the full dossier. Not a concern with the results, but a concern potentially with the timing, but we don't think that it would. That's why I say a week or so is our expectation at this time. If we need that expert. Yeah. [John.] Appreciate it. Thank you. [Thank you.] Thank you, Jeff. Good morning. Yes, in regards to Q4, we do not expect seasonality in Q4. Again, we feel like it's for rosacea and psoriasis, it's a Q3 dynamic within the summer months. As we've seen kind of end of October and what we expect for November and December, we feel confident on the Q4 uptake in seasonality. Appreciate that. I guess just one more follow-up question on SATO. Is there, and beyond the MOU program, any other update around the other programs that they have rights in, and timing and/or financial implications around potential milestones? No update at this time. They are continuing to pursue SB206 in Molluscum and are advancing their development program, as expected. Okay. Thank you. Sure. Thank you, Jeff. Operator? Yes, ma'am. The next question will come from Jennifer Kim with Cantor Fitzgerald. Please go ahead. Hey, everyone. Thanks for taking my questions. I have a few here. One is sort of a follow-up from the last question. The memorandum of understanding with SATO, could you give any color on what the terms of agreement could ultimately look like and when we could get an update on that agreement moving forward? Related to that, I'm just wondering how your discussions around other territories, how that's going. Okay. Thanks, Jennifer. In terms of the memorandum of understanding, you know, we are moving toward the definitive agreement, and it's our plan to have that before the end of the year. We will share those terms as soon as we can. Those terms generally include, you know, an upfront milestone payment and royalties thereafter, and that would be for Japan, and then the right to, for SATO to have agreements in other Asia PAC territories as well. So as soon as we have those details, we will certainly share them, and we're trying to move to a definitive agreement quickly. In terms of other territories, we do have interests and continue to have conversations. As you've seen, and as John's described with RHOFADE in the U.S., it's a good product, and there is interest in other countries to bring RHOFADE to market. We have global rights to RHOFADE, and it is currently only marketed in the U.S. It's a product that we see gaining momentum in other territories. Okay, that's really helpful. My second question is on WYNZORA. I think during the call you commented that you lost no market share within the topical psoriasis market. Does that mean the impact from this quarter was primarily due to seasonality? Because I would think if newer topicals are expanding the overall topical market, you maintaining market share means that you're sort of benefiting from that expansion. Yes, great question. Yeah, that's what we're seeing. If you look at it, obviously the non-steroidals have had an impact, a positive impact on the market. When you look at the steroids themselves, the monosteroids, you know, it's tough 'cause they're written for multiple things outside of psoriasis, but when you look at the segment, they maintained. We saw the loss really in the branded in the combination products. That's where you saw the hit quarter-over-quarter. When you look at the overall market, we were able to maintain our market share and our prescriber base. Yes, overall to your question. We've seen that stabilize towards the end of Q3 and in the beginning of Q4. As we noted, you know, we're excited about new innovation and new entrants into overall medical dermatology and especially in the psoriasis market on the topical side. We feel like we're very complementary to the new product entrants. There was a lot of investment, a lot of resource, and a lot of noise that was, again, very positive for our industry. I think that as it continues to sort itself out, we will continue to benefit from the growth of the market. Okay, great. Then maybe one more quick question on Molluscum. Regarding the analytical testing, is the way that you're thinking about timing based on your latest communications with those third parties? It is. That's, you know, I am not ruling out 2022. That's why I just said plus or minus, just, as we await final results coming in. That is our latest information. Okay. Do you anticipate issuing an update once that testing is complete, or would the next sort of update be the filing? Unless we have any issues, the next update will be the filing. I am feeling good about the next update being a filing. Okay, great. Thanks, guys. The next question will come from Kemp Dolliver with Brookline Capital Markets. Please go ahead. Thank you. Good morning. First, as we go into 2023, have you had any consequential changes in your coverage with the health plans? Yes. Thank you very much for the question. No, we've been able to maintain coverage or existing coverage that we've contracted for both RHOFADE and MINOLIRA. We will continue to see access to covered lives of about 55 million covered lives on WYNZORA. We've been able to maintain the coverage for each of those products heading into 2023. Thank you, Kemp. Do you have another? Okay. Yes. The other question is, on the topic of license agreements, with SB206, and I'm thinking really specifically EU, are you actively engaged in any discussions there for that product? Not at this time, Kemp. You know, we are really focused on RHOFADE and its immediate ability to add, you know, positive cash flow for us, or you know, add cash to our runway, I should say. The SB206, we're really waiting more for our submission, and then we'll more heavily pursue that as an option. Great. Thank you. The next question will come from John Vandermosten with Zacks. Please go ahead. Good morning, Paula, John, and John. Thought I'd start out with a question on the filing of the NDA. It looks like you'll be in pretty close parallel track with your closest peer, and I'm wondering if, you know, you think that having the FDA looking at two similar or, you know, the two products that are addressing the same indication provides any benefit or hurdle perhaps to approving? You know, with the FDA, we don't see it as a hurdle. The FDA has been reviewing our competitor because really, Verrica is not a competitor. I think that there's space for both because they are a medical benefit, we are a pharmacy benefit if either or both are approved. I think that with the FDA, the FDA is reviewing primarily their contract manufacturing organization, to my knowledge, and I think to everyone's knowledge publicly. You know, ours is a very different product. They are a device. We are a topical and, you know, they're very different products, so we don't see that as being the issue. The FDA is always reviewing multiple products at a time in the dermatology area, so that is not a concern for us. Okay, great. You know, Verrica's had a lot of interactions with the FDA over the last couple of years, you know, with the Molluscum products. I'm just wondering if, you know, you've been able to learn or glean anything from those interactions that will help you in the submission you're gonna make coming up here in a few weeks or month or so. Yeah. We've been focused on our interactions with the FDA, quite frankly. We've had a number through the last several years, and even this year as we prepare to file. We've had ongoing letters to and from the FDA, you know, really making sure that we are, you know, filing everything that they are interested in seeing and need. We've been very focused on our submission, so I'm really not gleaning anything from theirs other than, you know, learning about their CRLs with contract manufacturing. We are manufacturing here at our facility, our drug substance, and it is Berdazimer only. It is not competing with any other products in the plant. We are using a drug, a CMO for our drug product, and we've been working with them since 2018, and they have a very good, regulatory inspection history. We have not had those concerns. Okay, great. Yeah, things pretty clean on that side of the. Yeah. ... submission. Last one for me is on SB206 and some of the comparators you may be looking for in terms of pricing, and your analysis when it finally goes to market. What are you looking out there to, you know, come up with appropriate price that will, you know, go, you know, successfully go into formularies and get your insurance and things like that? Right. No, thank you. Thank you, John, for the question. There really aren't any comparators, so we're just having to look at what we believe that the market, you know, and is necessary for. I think John Gay has shared in the filing how much we have previously, you know, put into the company. I mean, you see a lot of, you know, the averages, it takes $1 billion to get a product to market, and I think we're around $300 million. So I think we're doing well in terms of our investment and potential return. In terms of where we see a unit, and a unit supply is around 28 days, and a unit supply would probably, based on our research, be somewhere between, you know, $600-$1,000 a unit. That is based on our research and payer and pricing strategy. Okay, great. That's very helpful. Thank you, Paula. Appreciate it. Okay. Thank you, John. This concludes our question and answer session. I would like to turn the conference back over to Ms. Paula Brown Stafford for any closing remarks. Please go ahead. Thank you, operator. We made good progress in the third quarter with our development efforts and with our promoted product sales. We achieved many milestones and have momentum in the fourth quarter with six or so weeks to go. We look forward to sharing our progress as we move through the quarter and into 2023. Thank you all for attending today's call. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.