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spk11: Hello everyone 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 and 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 is not independently verified or makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified any information obtained from the 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 M. Gay, Chief Financial Officer, and John A. D'Onofrio, Chief Operating Officer of Novant and President of EPI Health. I'd now like to turn the floor over to Paula Brown-Stafford, Chairman, President, and Chief Executive Officer. Please proceed.
spk02: Thank you, Jamie. Appreciate that. Good morning, and thank you for joining our corporate update. including Novan's financial results for the second quarter of 2022. I want to start off by stating that we remain steadfast in our belief that Novan remains a compelling investment opportunity, and I look forward to sharing with you during this discussion exactly why. As a reminder, on March 11th, we announced exciting news for Novan. We closed on the acquisition of EPI Health, truly a foundational leap forward for Novan. We've created a medical dermatology company that has the capabilities to discover, research, develop, and commercialize innovative therapies, bringing medications to patients with diseases of the skin. We've made solid progress and have great momentum going into the second half of 2022. We've delivered strong volume growth for our promoted products. We're very proud that in July, the results from our pivotal phase three study, Be Simple 4, were published in the JAMA Dermatology Journal, authored by Dr. John Browning and others. And it was preceded by an editorial titled, Molluscum Contagiosum Therapeutics, New Options May Be Around the Corner, written by Dr. Vikash Oza. Also in July, we paid off our promissory note for EPG with EPG for our $16.5 million, saving the company nearly $11 million of future expense with no securitization of the company's marketed assets. We're pleased to share that we're tracking toward our target submission date of no later than the end of 2022, for our NDA for Berdazim or Gel 10.3% as a treatment option and potentially the first FDA approved treatment for molluscum contagiosum. And finally, we're actively exploring partnership opportunities for Rofaid, our product for rosacea in ex-US territories. Our commercial platform is focused on execution, field readiness, engagement among our customers and employees with strong performance management across our organization to ensure we deliver value to the patients we serve and to our shareholders. We've demonstrated a commitment to the medical dermatology community with our diverse promoted product portfolio and with our strong development pipeline. Our commercial platform is built to expand disease states within the medical dermatology area, such as molluscum, and into other specialty areas, such as pediatrics. Our commercial organization is focused on expanding our promoted products in three of the top four dermatology markets through seven key mandates that you see here. We continued to execute on these commercial initiatives in the second quarter of 2022 toward helping to grow our commercial business. We hired our national sales lead, Carolyn Duracimo, in May, and I couldn't be more thrilled. And we completed the integration of our Novan Legacy and EPI Health leadership team at the beginning of July. We've also made good progress in nearly all of the remaining mandates. We are holding off on hiring into new territories at this time based on our current momentum that we have as is. In the second half of 2022, we'll remain focused on driving awareness of our brands, continuing to invest in our people, and as I mentioned, exploring ex-U.S. opportunities. Speaking of brand awareness, we've been busy promoting our product brands via sales and marketing and our product candidate, SB206, via medical education. Our commercial team and our medical affairs team have been supporting medical meetings and or contributing to scientific publications, sharing our data and our approved messages. Now, let's discuss at a high level how we performed in the second quarter of 2022. I'm pleased to report continued growth in total prescriptions for three of our four promoted products. Overall, double-digit growth from quarter one to quarter two. For Rofade, we're excited to have closed quarter two with, again, the strongest quarter in the history of the brand, now with over 40,000 prescriptions. which is a 33% increase above the prior year for the same period and 10% over the previous all-time high quarter of quarter one. When Zora, which was launched in mid-2021, has shown consistent growth month over month and quarter over quarter since launch, 26% growth in the second quarter compared to the first quarter. Menelira also had strong growth. nearly 50% growth compared to the same quarter in the prior year, with 38% above the previous quarter. Cloderm prescriptions remain down over the last quarter and the last year, but this is to be expected as Cloderm is not our focus. And as we ready our infrastructure for the potential addition of SB206 into the mix, if it's approved for molluscum. So overall, You see 50% growth in total scripts comparing quarter two of 2022 to quarter two of 2021. So in summary, we're really pleased with our performance and a quarter that met our internal expectations in terms of total prescriptions. Looking at Rofate specifically, the market in the U.S. is around 16 million people. Our Rofade product is the number one prescribed product for the treatment of persistent facial erythema, or facial redness. Rofade is fast-acting, and improvement persists with regular daily use over 52 weeks. We have driven growth in total scripts since early 2020, as you'll see here to the right, after acquiring the product in late 2019. Now on to Winsora. We have a strong partnership and a collaboration with MC2 Therapeutics for the commercialization of Wenzora in the U.S. for plaque psoriasis. This is the first and only water-based combination product of calciptriene and betamethasone dupropionate cream, ideal for knees, elbows, and scalps. We launched just over a year ago and have seen the number of prescriptions and prescribers grow quarter over quarter since launch. On to Minalera. Minalera is a minocycline for the treatment of acne, and it's the first ever biphasic delivery system for acne, offering functional scoring, weight-based flexible dosing. Here on the right, you can see that we've also seen solid growth in prescriptions over the prior quarters and years. Now, transitioning to our development focus. Our lead product candidate is Bradeisomer Gel 10.3% or SB206, a potential topical prescription treatment and likely the first FDA-approved treatment for molluscum contagiosum. In 2021, we reported robustly positive efficacy results from our pivotal phase three study known as B-simple-4. And recently, these results were published in JAMA Dermatology, as I mentioned. Molluscum is a highly contagious condition prevalent primarily in children aged 1 to 14, for which there is no FDA-approved prescription treatment. Dermatologists and pediatricians remain concerned with the tolerability of the currently sought office-based procedures. Our pivotal phase three study, B-simple four, demonstrated clinical and statistical evidence of efficacy with our primary and secondary endpoints and a favorable safety profile. So what now? We are now preparing for our potential NDA submission. As normal course of business, we are completing customary stability testing of our GMP batches of drugs substance and drug product. Importantly, we remain on track to meet our targeted submission date before the end of the year. We've been planning toward the potential launch of Berdasmagel 10.3%, or if approved, Consolis. We identified a path, the best and the most compelling path that delivers value. and that was to acquire an established business, EPI Health. This season's commercial team will launch and promote Berdasmagel 10.3% if approved. In the meantime, we've developed a launch plan with key activities ongoing in preparation for a potential launch. These include our commercial scale manufacturing capability, a pricing and reimbursement strategy, and continued outreach to our key opinion leaders through our medical affairs team and medical education. At Novant, as we've said many times before, we plan for success, and a product launch is no different. I'll now turn to John Gay, Novant's CFO, for our financial highlights. John.
spk09: Thank you, Paula. Good morning, everyone. We appreciate you joining our call today. This quarter represents the initial quarter in which we have fully consolidated results from our commercial business. As such, my comments will focus primarily on this quarter's activity as it represents the first data set regarding the performance of our commercial business on a full quarter basis. Before I touch on some of the key data points for this quarter, I would like to remind our participants that we are not yet in a position to provide guidance as it relates to 2022 revenues or EBITDA. However, as Paula noted, we certainly see opportunities for growth in our promoted product portfolio. For the second quarter ended June 30, our commercial business reported total revenue of 5.5 million. As you can see, year-to-date total revenue for our commercial business was 6.8 million. I will remind our call participants that the first quarter included only 20 days of activity for our commercial business based upon the March 11 acquisition date of EPI Health. Net product sales of Rofate included in the commercial business's total revenue was 4.3 million and 5.1 million for the three and six months ended June 30, respectively. Rofate prescriptions have continued to grow with a year-over-year increase of 39% for the six months ended Q2. and a year-over-year increase of 33% for the three months ended Q2. In addition, we continue to see opportunity for improvement in WSORA, which launched in Q3 of last year. I will now provide a bit more detail on our Q2 financial results, which expands to provide context for the information presented and complements the financial data presented in this morning's press release. Commercial product cost of goods sold was $2.6 million for the three months ended June 30. Cost of goods sold 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 $3.1 million for the three months ended June 30, compared to $5.3 million in the prior year period. The decrease of $2.2 million was primarily related to the SB206 clinical program based on timing of the B-simple IV trial. On a consolidated basis, SG&A expenses were $8.6 million for the three months ending June 30 compared to $2.4 million for the prior year period. The increase of $6.2 million was primarily due to $3.3 million of selling general and administrative expenses related to EPI Health's commercial operations, 0.6 million of transaction-related expenditures related to the acquisition, and a 1.2 million increase in investment costs related to the SB 206 prelaunch strategy and commercial preparation. On a consolidated basis, total net loss was 8.9 million for the second quarter as compared to 6 million for the prior year period. Net loss for our commercial business was 0.5 million for the second quarter compared to 0.7 million for the first quarter of this year. However, as I mentioned, the first quarter only included 20 days of activity. As you can see, a 28% year-over-year growth in our marketed portfolio prescriptions, excluding Windsor, which launched last year, coupled with a comparative improvement on the bottom line for the commercial business from Q1 gives us the opportunity to continue to drive optimization of our commercial business while at the same time investing in and looking forward to the potential launch of SB206. As it relates to our balance sheet, as of June 30, we had a total cash balance of $37.3 million and an accounts receivable balance of $18.2 million. We expect that we will need additional funding to support our planned and future operating activities and make further advancements in our product development programs. We do not currently have sufficient funds to complete commercialization of any of our product candidates under development. Therefore, we are pursuing a broad range of financing strategy and other strategic alternatives that could be used to extend our ability to continue investment in our SP206 product candidate. With that, I'll turn it back to Paula.
spk02: Thank you, John, for providing the detail behind the highlights. We are pleased with Novant's progress in the second quarter, on the heels of good progress in the first quarter. We have commercial momentum here at the front end of the second half of 2022. We continue to advance our efforts toward an NDA submission in 2022, having our drug substance and drug product now up on stability. We are planning for success and preparing ourselves for a potential product launch of Berdasmagel 10.3% if approved. We continue to pursue, evaluate, and consider collaborations that could expand our existing commercial products beyond the U.S., and we continue to explore our proprietary development pipeline for future growth opportunities. In closing, the full Novant team remains energetic, focused, and we've never been more excited for our future than we are today. So thank you. And operator, I'd now like to turn it to you to facilitate our Q&A session.
spk11: Ladies and gentlemen, at this time, we'll begin that Q&A session. To ask a question, you may press star and then one using a touch-tone telephone. To withdraw your questions, you may press star and two. If you are using a speakerphone, we do ask that you please pick up the handset prior to pressing the numbers to ensure the best sound quality. Once again, that is star and then one to join the question queue. We'll pause momentarily to assemble the roster.
spk04: And our first question today comes from Jeff Jones from Oppenheimer.
spk11: Please go ahead with your question.
spk07: Good morning, guys. Congratulations on a great quarter. on the consolidation of the businesses. Two questions. I guess as we look forward on the commercial programs, should we be looking at or considering any seasonality? We know looking at those prior quarters, Rofate's been a little tough in the third quarter, and Minolera is trended relatively, except for this quarter. And then on the FDA submission of SB206, are there any items we should be looking for as we head into the end of the year target? Thank you.
spk02: Thank you, Jeff. I'm going to take the SB206. 206 NDA question. I'm going to ask John D'Onofrio here to take the Rofade question. So maybe I'll just start with the NDA just in terms of any other items. You know, really, there are a number of activities. There are different modules being obviously prepared for the NDA, and we feel like we have everything in progress. There are ongoing interactions with the FDA in terms of how to present and share different information, but all of that is, as I say, customary and in progress, so we feel confident that we're going to have all that needs to be in order to submit before the end of the year. We are working, as noted on one of the slides, with third-party vendors with our analytical testing. So we're working with them to ensure that we get everything when we need it. And so we don't feel like there are any other items that are gating our submission.
spk03: Thanks, Paula.
spk04: And Jeff, good morning. This is John. Hope you're doing well.
spk08: Yeah, we definitely will see functionality in Q3. In Rosacea, typically July, August timeframe, due to vacations, summer vacations, July 4th and back to school, you see some leveling off in Rosacea, but we still continue to expect momentum and growth of just the overall growth aid brand, but you will see some seasonality. And then in regards to seasonality around our acne in Menolera, even though it was flat last year, I think you'll expect just with the back-to-school season and schools kind of back, you know, in full force kind of, you know, post-COVID environment, you should see normal activity in the back-to-school seasonality in the acne market, and we'll expect Menolera to follow that trend. So, you know, slightly impacted on Rofate just due to the summer months, but with acne season and back-to-school, you should see a little bit of an uplift from that perspective of seasonality.
spk04: Thanks, Sean. I'll hop back into the queue.
spk11: Thanks, Joe. Our next question comes from Kemp Dolliver from Brookline Capital Markets. Please go ahead with your question.
spk05: Great, thank you. As we head into the second half of the year, there will be managed care, formulary changes, Are your contracts multi-year? And the reason I ask is that there are several competing products that have popped up on the market in the last 12 months that do not have formulary coverage and presumably are knocking on managed care's doors to get positions. So how do you protect yourselves from their efforts?
spk04: Yeah. No, great question.
spk08: And yes, our care contracts are multi-year. Some are reviewed annually, even though they're multi-year contracts. It's an ongoing annual process, and as products leave and enter the market, you continue to see ongoing negotiations. We've been fortunate with Rofade to maintain the coverage across all our plans, and we'll continue to see that as we head into 2023. And we've seen very similar trends for Minolera and psoriasis. We're actively negotiating and going through category reviews with the payers as we speak. And I think the entrance of some new players, I think, has generated some excitement and positives around topical treatments and psoriasis. And we feel like this only helps enhance our position to the benefit of topicals and not just systemic and biologics. in the topical psoriasis space. So it's an ever ongoing discussion and opportunities and challenges, but right now we solidified coverage that built up over the years and we're continuing to look to add more as we negotiate and further come forward.
spk05: Thank you. That's helpful. The second question relates to the Rofade out-licensing. Are there – I mean, you obviously have a Japanese partner who is an obvious target for discussions, but how do you view opportunities beyond Japan? There's obviously Europe where you haven't out-licensed anything yet, I believe, even with the legacy portfolio. So broadly, how are you thinking about the – non-US markets.
spk02: Yeah, thanks, Kim. We're really focused on Japan, Europe, Canada primarily. We're having good discussions. As you know, it's a process. It's a selling cycle with multiple discussions and multiple parties and multiple regions and territories. So we're encouraged with our conversations, but we'll share more details along the way, if and when A or deals are agreed.
spk04: Okay. Thank you. Thank you.
spk11: And our next question comes from Jonathan Ashcroft from Roth. Please go ahead with your question.
spk06: Thank you. Good morning, folks. I was wondering, is the developmental pace of 204, you know, slowing down because I no longer see it associated with a timeline to start phase three, at least as per the press release.
spk02: Yeah, thank you. Thanks, Jonathan. You know, as we previously shared, you know, we prioritize our pipeline and SB204 is our second priority product candidate, you know, for acne. And as we focused on our commercial activities and the NDA for SB206, that's, you know, our current focus. But SB 204 remains a compelling opportunity for us. We really are excited to hopefully get back there. We're poised to initiate a final pivotal phase three, potentially in 2023, given adequate funding. So SB 204 is a new mechanism of action compared to anything on the market today for acne. We are excited to potentially advance SB 204 and potentially submit a second NDA with our NitroCell technology. We, you know, it's really a funding and timing issue for us. Other than that, we remain excited about the product.
spk06: Okay, thank you. You know, is SBO19 being retargeted to other viruses, you know, more so because you see less of an opportunity in COVID? Would that be more accurate or not?
spk02: Yep, you're exactly right. We're evaluating SB019 for just general respiratory diseases. You know, all the nitrosil technology products that have been in the clinic today are all a topical formulation, either gel or cream. So we've been focused on a non-topical formulation for respiratory diseases. So, you know, the COVID... Market is pretty crowded at this point, and it behooves us to look at the broader respiratory market. So, again, though, until future funding or partnering presents itself, we'll evaluate it in a preclinical setting for that broader range of respiratory diseases, increasing that optionality for SBO19 as a potential product candidate.
spk06: Okay, and lastly, just two parts to this. R&D. Is that to stay down here, or is 2Q an anomaly? And for SG&A, especially since you didn't terminate anybody from EPI, why is that down 14% sequentially, and what should we expect of that going forward, those two main expense lines?
spk09: Thanks, Jonathan. So as it relates to R&D, the two expense line items, You know, R&D really has ratcheted down, and as it relates to the continued progression of getting 206 and through a regulatory perspective, you know, that is kind of more of a normalized level once you take out the clinical trials. So really, R&D, you know, is down, and as we continue to progress, 206 will stay more in that range. If there's an opportunity for 204, like Paula just mentioned, that could change in the future. As it relates to SG&A, you know, there's a lot of variables now in SG&A. You know, historically, Novant had general and administrative expenses, and now with the EPI acquisition, the lion's share is now selling. So as it relates to period over period, you know, if you take out the activity from the SG&A or the selling expenses from EPI health, You know, really, there are other activities that are going through there from a legacy Novant business relate to the acquisition, you know, which are one-time type of expenses. So, as we look forward to SG&A in the future, obviously, we'll look to optimization of certain cost areas, but there are some anomalies, if you will, from a period-over-period perspective, primarily generated from the EPI health acquisitions.
spk06: Okay. Thank you very much for that. And thank you guys for being one of the only people who actually put your press release out, you know, a useful lead time before a conference call. I really wish you would spread that philosophy.
spk02: John was up early.
spk09: You're welcome, Jonathan.
spk06: Take care, guys.
spk11: Thank you. Our next question comes from Oren Livnat from HC Wainwright. Please go ahead with your questions.
spk10: Good morning. Thanks for taking the questions. I have a few. If I could just piggyback on John's question about SG&A, I think he was remarking on how low it was, which I think surprised us and the street with regards to the incremental addition of EPI selling expenses. I think you said it was only about $3.3 million and profitable in the quarter, and that's, I think, significantly better than than I had modeled. So just going forward, is that the expectation that that business is profitable and staying profitable on an operating basis, you know, the standalone business? And I have a follow-up.
spk09: Yes, certainly, Warren. Good morning. Thanks for the question. Yeah, as it relates to that, you know, as we said publicly before, you know, we're really looking toward improving the contribution margin of the commercial business. You know, we saw that in this quarter. you know, on a go-forward basis, that line item of expenditures is really going to be part of a continuation, but also as it relates to some of the mandates that Paula touched on in the prepared remarks, you know, continue to driving, you know, script volume. So, at the end of the day, you know, that will vary based upon either some of the mandates that we are rolling out and continuing to pursue, or it could, you know, be managed from an optimization standpoint. So, You know, again, from a kind of a quarter-over-quarter rate, this is the first quarter that we have a full quarter of EPI health. So on a go-forward basis, we'll see. But, you know, I think that this is, you know, a baseline that we can certainly measure against in the future.
spk10: Okay. And just one more question on EPI before I ask about 206. Was there a change to revenue recognition with regards to Winsora? I think did something move out of collaboration and into product revenue? And does that hit, you know, margins, I think gross margins – We're about 55%, which is down quarter over quarter. And I'm just wondering what we should think about going forward on the profit margin side.
spk09: Yeah, that's a good question, Oren. Yes, there was a, you know, again, with only 20 days of activity, there wasn't really a whole lot of activity from a revenue perspective related to the MC2 agreement. But, yes, there has been a slight change in presentation with regards to the LNC or the License and Collaboration Revenues. You know, that adjustment was roughly, you know, $0.4 million for this quarter, three-month ended. On a go-forward basis, that, you know, this is a one-time adjustment, if you will. So, going forward, as it relates to kind of the, regardless of, you know, the impact to net income is zero, regardless of how the presentation is shown for NMC2 revenue recognition. But now, yes, we are showing the gross sales of Winsora in top-line revenue. and in product revenue rather than as part of a licensing fee in LNC revenue.
spk10: Okay. And the gross margin profile on that business in general now and going forward?
spk09: Yeah, so gross margins get interesting, you know, as it relates to the MC2 agreement because effectively, you know, we are commercializing and distributing that asset on behalf of MC2. Uh, so I think if you, if you look at the core business of, um, the, the assets that we own, uh, you, you, you would have to kind of calculate or back calculate a margin with respect to that. So I think looking primarily at, you know, Rofade, Cloderm, Minolera, seeing that net product revenue and looking at that, uh, is probably more indicative of true impact on in the future as it relates to cashflow. So the gross margins, um, are a bit skewed for this quarter, but on a go-forward basis, we expect it to be, you know, this to be the baseline and this to be expected going forward.
spk10: Okay. And then on SB 206, and thanks for taking all these questions, there is material year-over-year spend pre-commercial, I think you called out, and I do appreciate all the detail you guys have provided in general across the business. You know, you're potentially, you know, a month away from a filing, and then you have another year to review the Between now and potential launch of this product, how much pre-commercial activity do you think you'll be engaged in and how much investment ahead of building a sales force and launching this product should we be thinking about?
spk09: That's a great question, Oren. As we said, currently we don't have the funds to get us to full commercialization of any of our product portfolios. So a lot of that will be determined upon our access to capital and different financing strategies. But preparing for a new product launch, as you know, is a multivariable equation. So part of it will be the ability to access capital. But really, we've already solved a part of the equation with the infrastructure and sales force that we have with EPI Health. That's kind of already in the bag, if you will. But as we continue to prepare the market, educate the market, and launch that robust plan to really try to benefit the max upside for the launch of Consolus approved, that can be a variable amount, again, based upon the availability of capital. There's what we would like to do, and that's what we're pursuing to do. But, again, there's a lot of variability based upon our ongoing operations and our ability to access capital. Okay, thanks. Thanks, Oren.
spk11: Thank you, Oren. Our next question comes from Jennifer Kim from Cancer Fitzgerald. Please go ahead with your question.
spk01: Hey, thanks for taking my question. So I have a couple here. The first is on Rofate. How much more opportunity do you see in terms of uptake for that product? And this relates to what you said about Ashene, this quarter being a good basis going forward. Is the expectation that you can continue that growth without added promotional or selling investments? And then my second question is, I know you talked about active engagement with potential partners for Rofade. Can you just outline how you view the Rosacea opportunity in the EU and how the size of that is relative to the U.S.? Thanks.
spk04: Hey, Jennifer, this is John.
spk08: I'll take the U.S. opportunity for Rofate, and then I'll pass it on to Paul and the rest of the world. But from a Rofate perspective in the U.S., you know, we expect growth in the brand throughout the patent lifecycle. There's a tremendous opportunity for us to expand the treatment of neurovascular dysregulation in every rosacea patient. You know, we're a category leader in persistent erythema with redness. When you look at the components of, when we look at the two components of rosacea, you've got the inflammation and then you've got the treatment of persistent facial erythema. So, and our goal here is to continue to have each and every patient be treated for persistent facial erythema and underlying treatment of neurovascular dysregulation. So, as we look at that opportunity and look at the market size, you know, we have about 95% of the PFE market but we just have a small portion of the inflammatory market. So if we look at it being multifactorial and actually getting every rosacea patient on Rofate for the treatment of PFE, we see still an opportunity. So we'll see that we expect that to continue to grow as we continue to evolve that message throughout the life cycle and do not see or expect a dip from that perspective.
spk02: And, Jennifer, on the partnerships, I think you're specifically asking about Europe. Certainly, there is rosacea in Europe. The size of the market depends on the country. And the PFE, as John mentioned, being what we are primarily targeting is There is, and certainly in specific countries, there's more PFE than in others. So, you know, we're not, you know, those are ongoing conversations with different partners in terms of that potential market. So I don't want to, you know, project what we believe the market to be at this time, but we do believe there's an opportunity.
spk09: And then just add to that. Sorry, Jennifer. With respect to SG&A, again, for clarity, $3.3 million this quarter. It's a baseline that will basically vary with the execution of some of the other mandates, as Paula talked about. So I think it's, again, a baseline. But as we continue to make some investments, that can vary in the future based upon the level of that investment related to those mandates.
spk04: Okay. Thanks, guys.
spk11: Our next question comes from John Bannermosten from Zax. Please go ahead with your question.
spk00: Hey, Paula and John. Good morning to you guys. I wanted to ask about just the post-pandemic demand, perhaps, for dermatology products. You know, you've seen pretty strong growth, and I'm wondering if you sense that it might be coming from that source. And also the summer, perhaps, you know, people are outside, more outside of the house.
spk02: Yeah, well, maybe I'll start and then John D'Onofrio maybe can add again about the seasonality with the different products. But in terms of post-pandemic, you know, I mean, you know, I think everybody saw a little bit of a dip in 2020 and things were coming back in 2021 as doctor's offices, you know, were really opening back up in 2021. So I think from You know, certainly 2020, you know, we've seen a post-pandemic demand. But, you know, 2021 and 2022, you know, are more comparative. But, you know, I think starting in 2022 is when we've seen things get, you know, pretty normal, you know, for all of us. And, you know, I think that the growth you're seeing from quarter one to quarter two is has everything to do with our efforts and our growth mandates that we've put in place to drive the increase in sales. Anything you want to add, John?
spk08: Yeah, I would agree, Paula. Obviously, there's some small dynamic, just things opening up a little bit more. But, John, what we'll look at, too, to support that is we've seen an increase in volume, but we're also seeing a significant increase in riders. So if we saw the same amount of writers year over year and just increased volumes, you're going to attribute that to patient access and more patients coming in. And I think what we're seeing is both volume in scripts and new writers as well across each one of the categories in psoriasis, acne, and rosacea. So we are seeing better access to offices now, so we can continue to and get more education to our healthcare practitioners. So that's also a piece that's driven by COVID opening up, if you will. But I think, as Paula mentioned, the volume based on the metrics we're looking at, based on the new riders and the productivity of the new riders, is as much as on execution as it is just a COVID dynamic. Okay. Okay.
spk00: And on DTC advertising, is that something you'd consider, and do you think that would be effective here since, you know, it's a lot of times consumer-driven?
spk08: When you look at DTC, you know, obviously when you look at the big brands and the big biologics, the big pharma companies, we won't look at it from, you know, a direct-to-consumer advertising, commercials and TVs and so forth, but there is absolute awareness we can do from a data perspective that we have programs for that will educate patients on rosacea, persistent facial erythema, and our other disease states. So we'll look at it more to a digital perspective and definitely will reach out to our consumers and patients. But our primary focus is on education and promotion to our healthcare practitioners around the benefits of our medications. And just the economics. From that perspective, as a smaller company, trying to make sure we ensure we get the right value to our shareholders, we'll look at more cost-effective ways that we'll get the same message across for our particular products.
spk00: It seems like a digital campaign might be a really effective use of your spending for that, I guess. It sounds like that's the direction you're going. Yes. Okay. And last question, just on inflationary pressures, product inputs, and perhaps other things. Any comments on that? And if you see them tapering off, slowing down, or, you know, what direction do you sense in terms of inflationary pressures on the income statement items?
spk09: Yeah, good morning, John. Thanks for the question. Yeah, we really haven't noticed any, you know, inflationary pressures, you know, one way or the other. You know, we've talked about, you know, in previous quarters, you know, kind of The general economic environment, supply chain stuff has been more of an issue in the past, but as it relates to the inflation in the current market, we're not really seeing anything that's driving one way or the other.
spk00: Okay, great. Well, John, Paula, John, thank you so much for taking my questions. Appreciate it. Thank you, John.
spk11: And our next question is a follow-up question from Kemp Dolliver from Brookline Capital Markets. Please go ahead with your follow-up.
spk05: Great, thank you. Excuse me. How are you thinking about the competitive situation when you launch Consolus? I think if we were going back a year ago, it was a fair assumption that you were going to be second to market. And now, given the changes and the dynamics, you could effectively be going head-to-head at the time of launch. How is that influencing your thinking with regard to your launch tactics and strategy and how you might be working with plans to get formulary coverage?
spk02: Yeah, thanks, Kemp. You know, we've always contended that the market has room for both the Verica product and the Novan product. Our treatment is a prescription treatment. that would be used at home. And the Barica product is an in-office medical treatment. And we think that they are complementary. So we've always had that in our assumptions that there would likely be the two in the market. And so we'll still plan for that. I think whether they go first or we go first, hopefully, we're both going. and both get approvals. For us, it really doesn't change because we will be in the doctor's offices already. We're already there with our sales force, and we'll just put this in the bag and begin having those conversations very quickly. So we think that we have a very accelerated launch with our commercial platform ready to go. and regardless of whether we're first or they're first.
spk04: So, good question. Thank you. Great. Thank you.
spk02: Yeah. Operator, anything else?
spk11: Ladies and gentlemen, at this time, and showing no additional questions, I'd like to turn the floor back over to you, Ms. Brown-Staffer, for any closing remarks.
spk02: Okay. Thank you, operators. Quarter two, as you saw, was another positive step forward for NoVan and we believe for our shareholders. So we've got a first-class commercial team and a supporting infrastructure to propel us forward, further forward. And so in summary, NoVan has still five product candidates in our development pipeline. We've got four products promoted by our commercial team. We've got three near-term value creators. two priority products, and one lead product candidate. We've got two business units, and we've got one NDA submission targeted before the end of 2022. So we're excited for the remainder of the second half of 2022 and going forward. So thanks, everyone, for attending the call, and thanks to our analysts for some great questions. Have a great rest of your week.
spk11: And ladies and gentlemen, with that, we'll conclude today's presentation and conference call. We do thank you for joining. You may now disconnect your lines.
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