Novan, Inc. (NASDAQ:NOVN) Q4 2022 Earnings Call Transcript

Novan, Inc. (NASDAQ:NOVN) Q4 2022 Earnings Call Transcript March 30, 2023

Operator: Hello and welcome to the Novan Inc. full year 2022 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 that a replay will be 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 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 those contemplated by such forward-looking statements are discussed in the periodic reports Novan 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 that or of any independent source that has verified any information obtained from any third party sources. Joining us on today’s call from Novan’s leadership team are Paula Brown Stafford, Chairman, President and Chief Executive Officer; John A. Donofrio, Executive Vice President and Chief Operating Officer; and John M. Gay, Chief Financial Officer. I would now like to turn the conference over to Paula Brown Stafford, Chairman, President and Chief Executive Officer. Please proceed.

Paula Brown Stafford: Thank you Operator. Before I begin my formal presentation, I would like to take a moment to recognize two important individuals to me and to the full Novan team. Both individuals recently passed away: first, Dr. John Palmer, one of our original board members and shareholders passed away in November, and second, Mr. Bob Ingram, previous Chair before myself of the Novan board, a decade-long member and shareholder and an icon in the pharmaceutical industry passed away this past weekend. I ask for just a moment of silence in their memory. Thank you. Now I would like to thank our stakeholders and analysts for joining our annual earnings webcast and general business update. Novan is building a premier medical dermatology company that is focused on developing and commercializing innovative therapies for diseases of the skin.

In January, we submitted our NDA for berdazimer gel 10.3% for the treatment of molluscum contagiosum. Our filing has been accepted for review and we were provided our PDUFA goal date of January 5, 2024. We are in the review cycle with nine months remaining, hence we anticipate a potential FDA approval in the first quarter of 2024 if not before. Importantly, we could be the first FDA approved prescription treatment solution for molluscum. Over the course of 2022 and in the first quarter of 2023, we have achieved a number of noteworthy accomplishments. We remain excited about our progress, our momentum and what lies ahead. Our NDA was filed and accepted for review with no known potential issues. This followed our submission in January which followed the completion of our CMC and analytical testing, which we had shared with you, which was required for submission.

Prior to that in July, the results from our pivotal Phase III trial were published in JAMA Dermatology, and to start 2022 we acquired EPI Health, which had marketed products and a commercial capability to launch berdazimer gel 10.3% if approved. We firmly believe that Novan remains a compelling investment opportunity. Speaking of berdazimer, berdazimer sodium, our active pharmaceutical ingredient, is a new chemical entity, and berdazimer gel 10.3% is a novel topical nitric oxide-releasing medication for viral skin infections. Our NDA is based on a Phase III program that demonstrated clinical evidence of efficacy and a favorable safety profile. As I mentioned, clinical trial data from the B-SIMPLE4 trial were published in 2022 in JAMA Dermatology and, 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 contagiosum has no standard treatment of care today. More than 70% of molluscum patients go untreated. 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 one million new patients annually. Approximately 90% of pediatricians have a wait-and-see approach. We believe the lack of at-home options results in many undiagnosed cases. Berdazimer gel 10.3% has the potential to become a first line therapy for molluscum. Dermatologists and communities will lead the way and we expect pediatricians to follow. As I mentioned, there are no FDA approved treatments today. Our NDA is in the review cycle and we are expecting the review to be complete by the goal date of January 5, 2024, again just nine months away.

As we respond to FDA information requests, we are also investing in a successful launch in 2024. Specifically, we are planning to build awareness and excitement for our potential product among our customers and our employees to educate healthcare providers about the disease and the treatment options to deliver the best possible access program. Based on our market research, we expect favorable access with payors, to prepare our existing commercial organization and to protect our proprietary platform technology with patents, both nationally and globally. We are committed to the medical dermatology community with our diverse portfolio of promoted products and with strong development pipeline. Our commercial unit is built to expand disease states within the medical dermatology area, such as molluscum, and to other specialty areas such as pediatrics.

I’ll now hand the call over to our Chief Operating Officer, John Donofrio to provide an update on the successes of our commercial unit in 2022. John?

John Donofrio: Thank you Paula, and good morning everyone. Our commercial organization provides an established foundation for the potential berdazimer launch with an ideal complement to our R&D and manufacturing expertise. Our commercial capabilities include an integrated platform with supply chain, patient access and distribution, with a sales and marketing team ready to scale for the future. We start with supply chain management of our third party suppliers along with an optimized demand management process and distribution capability to both wholesalers and direct network pharmacies. Our market access strategy focuses on favorable insurance coverage volume complemented with patient affordability programs to ensure patients have affordable access to our medications.

Our dedicated marketing team has significant experience in dermatology with demonstrated success with brand and disease state messaging and education. Our team has extensive launch experience across numerous therapeutic areas both in competitive selling and medical education, providing a solid foundation for our potential future launches. We have also built strong professional relations engagement with our healthcare practitioners and key opinion leaders across the country. Our sales organization consists of four regions in 42 territories with the ability to reach more than 4,000 healthcare practitioners across the country. We’re extremely excited to prepare for the potential launch of berdazimer gel 10.3%. While we’re excited about the future, let’s review our promoted product growth in 2022.

I’m pleased to report that our promoted products delivered strong double digit prescription growth for the full calendar year. All three brands exceeded targets established at acquisition and each outperformed the growth in their respective markets. We are also pleased to see similar strong double-digit prescription growth for the fourth quarter, demonstrating our continued focus on execution of our commercial plans, strong prescriber base, and solid promoted product portfolio. I will now provide additional highlights in each of our promoted products. Rhofade is the number one prescribed treatment for persistent facial erythema – PFE, or facial redness, owning approximately 90% of the market. Our growth strategy is to continue the expansion of the PFE market and increase the number of rosacea patients treated for redness.

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Q4 prescription volume of 40,791 prescriptions was just shy of an all-time high set in Q2 and total prescriptions for December exceeded 15,000, the highest ever monthly total for the brand. We are also extremely excited about the opportunities outside the U.S. for Rhofade, starting in Japan with strong potential to expand in other markets. As we complete our first full year on the market with Wynzora, we have established a strong first base of prescribers. We have a partnership in collaboration with MC2 Therapeutics for the sales and marketing of Wynzora in the U.S. for plaque psoriasis. As we’ve covered in our previous calls, a new competitor launch in Q3 has challenged the use of topical steroids for psoriasis. You can see the impact in the reduction of total prescriptions from Q2 and we have primarily remained flat for the second half of the year.

However, despite the strong competition, Wynzora managed to finish Q4 with no loss in market share within the topical psoriasis market, and today Wynzora outperforms all competitors on average number of total prescriptions per writer, or productivity. 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 increasing brand awareness and the continued expansion of our writer base. MinoLira is an oral minocycline for the treatment of acne, offering weight-based flexible dosing for patients with the first-ever biphasic delivery system. We’ve seen significant growth in prescriptions since increasing our promotional efforts on the brand this year.

We delivered our largest growth in MinoLira prescriptions during the third quarter and are extremely pleased with the 68% growth in Q4 versus last year. The reduction in Q3 all time high was in part due to seasonality and competitive supply challenges in Q3. MinoLira’s strong growth in 2022 was a highlight in the overall market that declined 10% throughout the year. Overall, we’re extremely pleased with the performance and continued prescription growth of our promoted brands. Thank you, and I will now hand it over to John Gay, our Chief Financial Officer.

John Gay: Thank you John. Our December 31, 2022 year end represents our first fiscal year in which we have fully consolidated results from our commercial business. I’ll remind you that when I refer to year-to-date figures, this represents 295 days of activity based upon our March 11 acquisition. I would like to let our listeners know that we are not yet in a position to provide guidance as it relates to Q1 and full year 2023 revenues EBITDA. As of December 31, our year-to-date commercial business reported total revenues of $21 million. Net product sales included in our commercial business’ total revenue was $11.5 million for Rhofade, $1.6 million for Wynzora and $1.6 million for MinoLira, with other products in our portfolio contributing $1.1 million year-to-date.

In addition, our commercial business also reported licensing and collaboration revenue of $5.2 million comprised primarily of the $5 million out-license agreement for Rhofade signed in December of 2022 for the Japanese territory with Sato Pharmaceuticals. For our promoted product portfolio, Rhofade prescriptions have continued to grow with a year-over-year increase of 33%. We continue to see market opportunity for improvement and Wynzora, which John mentioned launched in Q3 of 2021. In addition, MinoLira prescriptions have continued to grow with a year-over-year increase of 61%. As of December 31, 2022, our year-to-date R&D business reported total revenues of $2.7 million. This amount related to the Sato agreement related to the Japanese territory out-license of two of our product candidates, including berdazimer gel 10.3%.

I will now provide a bit more detail on our fiscal year 2022 financial results, which expands on the information filed this morning with our earnings release and in our annual report on Form 10-K. Total cost of goods sold was $7.4 million for the year ended 2022. Cost of goods sold includes the cost of procuring finished goods from our third party manufacturers, sales-based royalty and milestone expenses, and other third party IP licensing costs. For the year ended December 31, 2022, we recognized net product revenue related royalty expense of $4 million within cost of goods sold. This amount included our current obligations to third parties in addition to amounts related to the accounting presentation for the MC2 license agreement of $1.4 million.

In addition, $1.25 million was included in cost of goods sold as part of the Sato Rhofade license and collaboration upfront payment for the Japanese out license agreement due to a third party. Our R&D business incurred research and development expenses of $16 million for the year ended December 31, 2022 compared to $20.4 million in the prior year. The decrease of $4.6 million was primarily driven by decreased clinical costs associated with the timing of the B-SIMPLE4 trial totaling $7.7 million, offset by an increase of $3.1 million of costs related to regulatory activities, stability testing, CMC and material costs to support our berdazimer gel 10.3% NDA filing. On a consolidated basis, SG&A expenses were $34.1 million for the year ended December 31, 2022 compared to $12.3 million for the prior year.

The increase of $21.8 million was primarily due to $13.7 million of selling, general and administrative expenses incurred to support the conduct of our commercial operations acquired during the year, $4.7 million of transaction-related expenditures related to the EPI Health acquisition, $1.1 million of investment costs related to the SB206 pre-launch strategy and commercial preparation, and $2.3 million of facility and depreciation, personnel and other general and administrative costs. For the year ended December 31, 2022, we also had $2.9 million of other income, which was composed of a $4.3 million gain on debt extinguishment related to the promissory note issued in March of 2022 in connection with the EPI Health acquisition, partially offset by $1.4 million of interest expense incurred prior to the settlement of that promissory note in July of 2022.

On a consolidated basis, total revenue was $23.7 million for the year ended 2022 compared to $3 million for the prior year. Consolidated net loss was $31.3 million for the year ended 2022 compared to $29.7 million for the prior year. Our commercial business net loss for the year ended 2022 was $1.8 million, and our R&D business net loss for the year was $29.5 million. As it relates to our balance sheet as of the end of the year, we had a total cash balance of $12.3 million and accounts receivable totaling $22 million. Since December 31, 2022, we closed a registered direct offering for gross proceeds of $6 million. We receive the Sato upfront payment of $5 million related to the Rhofade out-license agreement, and we have continued to use our $15 million accounts receivable factory facility executed in December of 2022, which provides working capital in an amount that is up to 70% of our commercial business’ gross eligible receivables.

We will need additional funding to support our plan and future operating activities in our berdamizer gel 10.3% product candidate and our business in general. We believe that our cash balance as of December 31, 2022 plus expected receipts associated with product sales from our commercial product portfolio and the proceeds of the March 2023 registered direct offering will provide us with adequate liquidity to fund our planned operating needs into the latter part of the second quarter of this year. Variability in our operating forecast driven primarily by commercial product sales, timing of operating expenditures, and unanticipated changed in net working capital may impact our cash runway. We are tirelessly working to obtain the additional funds necessary to get to a potential approval and launch of berdazimer gel 10.3%, if approved, including evaluating potential strategic opportunities while at the same time conserving cash by delaying or deferring certain expenditures.

We have been pursuing and will continue to pursue additional capital through a broad range of financing strategies and other strategic alternatives. Other potential funding activities may include equity financing, convertible debt, or capital from other sources, or traditional debt financing. With that, I will turn it back to Paula.

Paula Brown Stafford: Thank you John Gay, and thank you John Donofrio. Listeners, you’ve heard an update regarding our lead asset, berdazimer gel 10.3%, our commercial operations and our financial update and status. Novan is in a solid position to succeed with a potential approval and the infrastructure to support a launch. We are therefore focused on driving towards the potential approval of berdazimer gel, on aligning our commercial infrastructure to support a potential launch, on continued growth of our marketed products, Rhofade, Wynzora and MinoLira, and on pursuing additional ex-U.S. out-licensing opportunities. In closing, we at Novan remain focused and excited for our future. Thank you, and Operator, you may now open the line for questions.

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Q&A Session

Operator: Yes, thank you. At this time, we will begin the question and answer session. The first question comes from Jonathan Aschoff with Roth.

Jonathan Aschoff: Thank you. Good morning guys, and congrats on the increasing sales. You guys have definitely talked about some of the special items that have led to, I guess, like a 74% COGS for the fourth quarter, but what can you say about gross to net for 2023, and also should R&D drop substantially in that year–I mean, in this year versus last year?

John Gay: Yes, thanks Jonathan, good morning. This is John Gay. Thanks for the question. To your point, making sure I touch on all of them, COGS, you’re correct – there is some atypical activity for the current quarter as it relates to the Sato agreement. As it relates to your question on gross to net, I’ll give a little bit of background, as you know, but I think it might be helpful. The components of gross to net, or GTN deductions could really be categorized in two parts: first, the actual activity based upon the number of prescriptions filled by our patients in a given period, and second estimates used to project future activity for prescriptions not yet filled for patients as the channel inventory held at wholesalers were for our pharmacy-direct customers.

But both components, both of those GTN components, consider them as–you know, if you think about the most significant line items for those deductions, it’s comprised of payor rebates, co-pay coupons, and reserves for products. Each period, we update our gross to net deductions for both parts, both the actual and the estimated. The actual activity can vary based upon the numbers and method of how prescriptions are effectively filled by our customers – for example, what insurance program they’re covered by, what healthcare plan they’re on, and which PBM is utilized. In addition, the mix of coverage of PBM versus coupon will vary by the underlying patient, so this product mix and changes period over period will impact the actual GTN deduction and may up or down over time.

The estimated activity for that part of the gross to net is going to also vary based on how we utilize historical trends paired with assumptions to project future deductions based on channel inventory, open lots and other factors. During the fourth quarter, you’re right – we saw TRx increase for certain products, for Rhofade for example, but we also saw a decline in the period-over-period gross margin for that. This was based upon the gross to net deductions, based on actual activity as it relates to payors and coupon mix, and our estimates which are based upon historical trends and year-end accounting adjustments. Both the commercial and finance teams are working closely with our partners to work towards optimizing both the payor and coupon mix, if you will, and we’ll continue to focus on improvements in the near term.

John Donofrio, would you have any thoughts on that?

John Donofrio: Yes, thanks John. Jonathan, thanks for the question, too. I think as you know, probably the industry issue across the board with some challenges, and we have seen some increased rebates and some challenges at the pharmacy, but we’ve already started to implement in 2023 a better partnership with the PBMs to ensure that the coverage that we have acquired is actually pulled through at the pharmacy level. We’ve also looked at a copay card redesign to ensure the business rules that we set in place, to make sure there’s access but also profitability on our scripts implemented, and we’re also looking to implement an e-hub service to help facilitate the scripts and ensure that our scripts go through, to follow the coverage that we’ve won and earned as we focus on 2023. I think there’s some critical operational programs that have already been started or that will be implemented in Q2 to ensure you see that kind of be just a bump for Q4 versus an ongoing trend.

Jonathan Aschoff: Okay, and the second part of that question was the R&D drop. Should that be substantial this year versus 2022?

John Gay: Yes, so obviously with the reduction of the clinical trial, so it will–you know, we ended out the year down as it relates to prior periods, clearly because of the cost and nature of the clinical trials, but we will continue to have R&D expenses as it relates to the activities associated with the regulatory process, right, so as we continue to move toward the PDUFA goal date of January of next year, we will continue to have R&D costs associated with that, or costs that will be categorized as R&D because obviously prior to approval, the nature of those expenditures will be characterized as R&D. I think it’s fair to say that we will continue to have a relatively consistent R&D spend as we move toward the regulatory approval process.

Jonathan Aschoff: Okay. Does the year-end ’22 cash of $12.3 million include the $5 million that was booked in the fourth quarter, or does it not include that?

John Gay: It was not included, Jonathan. We had it as an account receivable, but we did collect that in January.

Jonathan Aschoff: Okay, and how much of it is paid out to a third party?

John Gay: $1.25 million–

Paula Brown Stafford: Twenty-five percent.

John Gay: –or 25%.

Jonathan Aschoff: Okay, and how much of the $15 million facility has been used?

John Gay: At the end of the year, we had $10.3 million as it relates to what had gone through as of the balance sheet date, but you can see it in our statement of cash flows, we had almost $20 million of usage, $18 million or so end of fourth quarter.

Jonathan Aschoff: Okay, but there’s no subsequent event footnote in the 10-K about usage subsequent to the fourth quarter end?

John Gay: That’s correct. We continue to utilize it at our discretion, but that’s correct. I think it’s fair to say that just the nature of commercial business and the nature of our payables and account receivables cycles and timing with our customers and vendors, it’s advantageous to have a working capital line, so we do continue to utilize it. It’s all again subject to our gross sales and activity from a TRx perspective.

Jonathan Aschoff: Okay, thank you very much, guys.

John Gay: Certainly.

Paula Brown Stafford: Thanks Jonathan. Operator?

Operator: Yes, thank you. The next question comes from Oren Livnat with HC Wainwright.

Oren Livnat: Thanks for taking the questions. I was hoping to talk bigger picture as you look forward to the SB206 potential approval in January. Can you just talk about what you’re able to do with the EPI business in place in terms of, I guess, priming the pump, so to speak, as like you said, we’re only theoretically nine months away and you’ve got boots on the ground already. What are your reps able to do now before a product is approved in terms of education, if anything, in terms of awareness building molluscum, and also when you think about a potential catalyst in another in-office procedure for Verrica’s product getting approved in July potentially, what kind of impact do you think that has on awareness in the space, and do you think that helps or hurts you guys heading into January approval of your own? Then I have a follow-up, thanks.

Paula Brown Stafford: Okay, thanks Oren. Our reps, we are not able to train them or prime the pump because we do not have an approved product. Our sales reps are aware and are excited to potentially have something to begin to talk to their healthcare providers about, but they cannot do so until it’s approved. If you will, the only way to prime the pump is through education, and we do that with our medical affairs group, and so we actually have four individuals in our medical affairs group and three of them are dedicated to really SB206, and that is around publications, presentations at meetings, be it abstracts or posters, or full on presentations. We were active at the AAD, the American Academy of Dermatologists meeting, which was just two weeks ago, and we were very active there and had a late breaker presentation that Dr. John Browning, one of our KOLs presented, and that was very exciting for us.

That’s how we can get out and build awareness, but with reference to Verrica, they will build awareness for the disease of molluscum if they are approved, so they have a PDUFA date in late July but, again, this is for a procedure, and as I said, we believe that we would be–once if approved, we would likely be the first line therapy because it is a prescription take-home gel topical treatment once a day, versus a procedure that is potentially requiring three of four doctor’s visits. But we believe because roughly 70% of patients today go untreated because there is no FDA approved treatment, we believe that there are patients that will begin to hear and be offered this–you know, it’s really not a new procedure, it’s a new way of delivering the same product, cantharidin.

But we have a novel new chemical entity that, again, is a prescription benefit as opposed to a medical benefit, so those are some of the differences.

Oren Livnat: Okay, and when you talk about preparing with your existing commercial infrastructure for that launch, can you remind us how much of that SB206 market is addressable with your current infrastructure versus how much you think you would need to scale up more and add onto your capabilities to actually launch it?

Paula Brown Stafford: Yes, it’s a good question. Thank you Oren. We will begin with the dermatologists because as I mentioned in my statement, we believe that the dermatologists will be the first to prescribe berdazimer gel if it’s approved, and we believe that in a community, the pediatricians know the dermatologists to whom they refer their patients for the treatment, because generally pediatricians don’t offer these in-office procedures. After they begin to see that the dermatologist is offering a prescription, they will look to the dermatologist as the key opinion leader in their community and then the pediatricians will follow. There are a large number of pediatricians in the U.S., it’s a very difficult market to call on with reps, and we are planning for digitally informing them once the product is approved, and that’s the way we would do that, and so it wouldn’t necessarily be increasing our number of reps at this point.

Preparing the field also means looking at the payor access and preparing for that, and then preparing ourselves to train a sales force. We are limited by our funds or lack thereof, and so this preparedness is an investment that we will make as funds are available.

Oren Livnat: Okay, and you kind of just segued on one more follow-up on payor prep. Can you just remind us, what’s your thinking on pricing? I know it’s early, but have you done any more since the data was out, since you’ve filed? Have you been doing more payor outreach and research and refining your thinking around likely net monthly pricing around the product?

Paula Brown Stafford: Yes, we did some market research in August of last year, and we continue to have some discussions. In terms of payor research, it was from August, and it was pretty much in line with the–you know, maybe a bit of an increase from what we had seen in 2019 when we went out and did that research, so we’ve updated it. We haven’t given guidance, but I know our analysts have been looking at anything between $500 and $1000 per kit, and a kit is–

Oren Livnat: Okay. Sorry, go ahead? I didn’t mean to interrupt.

Paula Brown Stafford: Yes, I was just saying, a kit is for four weeks of treatment.

Oren Livnat: All right, I appreciate the time. Thank you.

Operator: Thank you. The next question comes from Jeff Jones with Oppenheimer.

Jeff Jones: Hi guys. Congratulations on the quarter and thanks for taking the question. I guess two questions. In terms of cash needs, which you’ve spoken to in terms of where you get later–the latter part of Q2, what are you looking at to get through the year, and what does that allow you to do in terms of building up for sales and marketing prep for launch? Then, any update on discussions with Sato or others around further ex-U.S. partnering for Rhofade?

John Gay: Yes, thanks Jeff. I’ll take the first question as it relates to cash needs and S&M prep. If you look back at kind of the historical activity that we had during 2022, we were utilizing about $8 million to $10 million of cash on a quarterly basis. Going forward end of Q1, that should probably look similar. Really as it relates to from here forward for the rest of the year, it’s going to be dependent upon, to Paula’s comment just a moment ago, the amount of activity that we do to prepare the market, if you will, so that number could vary, but I think it’s fair to say that if we look at that activity, I think the prior year numbers, call it $8 million to $10 million on a quarterly basis, we can probably bring that down a couple of million on a quarterly utilization just based on some of the cost conservation measures that we’re doing, and also paired with the amount of activity we’re able to do as it relates to preparing the field.

So again, that can be variable, again it is dependent upon our access to capital. Then as it relates to Sato, ex-U.S.–?

Paula Brown Stafford: Yes, so ex-U.S., we have active discussions going on in many countries in Asia Pacific, Europe, Canada, others, so there is interest–I was going to qualify that, but there is interest in Rhofade because it is a very good product and a number of companies and countries are interested in that. We continue to progress those discussions and, as always, as we can or when we can, we’ll share the details of those discussions and those potential agreements. Thanks for asking.

Jeff Jones: Okay. Just a quick follow-up on Sato, I believe they had a limited time to exercise rights in certain additional territories. How much time is left on that, or has that expired?

Paula Brown Stafford: It has not expired, and we’ve got a couple months to go before that expires. We are aware and we’ll proceed elsewhere if for some reason that doesn’t move forward, so there is interest in addition to Sato.

Jeff Jones: Great, thanks guys.

Operator: Thank you. The next question comes from Jennifer Kim with Cantor Fitzgerald.

Jennifer Kim: Hey, good morning. Thanks for taking my questions. I have two here. Maybe on the first, following up on a prior comment, the digital investments that you’re currently planning, what degree of additional investment would go into that, and is there a way to think about your potential reach through digital investment or analog to other similar approaches to launches? Then my second question is I know you’re not in a position to provide guidance just yet, but is there anything you can say on, I guess, expectations on the cadence of growth over time and maybe when you believe you’ll be in a position to provide guidance? Thanks.

Paula Brown Stafford: Thank you Jennifer. I’ll take the first, John Gay will take the second. I think in terms of the digital investments and the investment for the potential launch of berdamizer gel is–you know, for us is measuring over time and balancing over time the funds available and the win, etc. I think one thing to say is that it’s not just sales and marketing but it’s also manufacturing, so it’s to be able to launch in 2024 and hopefully in the first half of 2024, we need to manufacture product, so I’ll put that spend ahead of some of even the sales and marketing to make sure that we have the product available, and then put that spend into 2024 if we don’t have it to spend in 2023. It’s a matter of how much you put in is how much you get out, and so we will continue to evaluate and balance our funds with the investment in our potential launch.

John Gay: Jennifer, good morning. I’ll take the first part of that–the second part of your question and then maybe ask John Donofrio to weigh in. But as it relates to guidance, we continue to evaluate that. Keep in mind, it’s been roughly nine months from a fiscal period that we’ve shown consolidated results, so I think we’re still working through that both internally and with the board on how to approach potential guidance going forward. That being said, as it relates to product or TRx growth and prescription growth, we continue to focus on that. Maybe John, you have some comments on that going forward?

John Donofrio: Yes, I think as you can tell, Jennifer, just the momentum we’ve had throughout the years across our products, we’ve had a few ups and downs in the psoriasis space, but we continue to be the market leader and expand persistent facial erythema, and we expect to continue to do that, that’s what our goal and our objectives are for 2023. I think the Paula and John’s point, the continued investment around that, we’ve demonstrated that that will also be dependent on funds going forward, but we expect to still grow that market and still seeing significant opportunity in the oral antibiotic market with MinoLira. Again, we feel like we’ve leveled out with the noise with the new–the competitors in the topical psoriasis market and we expect to see a rebound in that.

Again, we’re not giving guidance per se, but our brand plans, our tactics, we talked about SB206 and berdazimer plans, we have plans for all three products. They’ve all been initiated in a national sales meeting in early March and are being active, so we would expect to continue that momentum that we’ve seen.

Jennifer Kim: All right, thanks for taking my questions, guys.

Paula Brown Stafford: Thank you Jennifer.

John Gay: Thanks Jennifer.

Operator: Thank you. The next question comes from Kemp Dolliver with Brookline Capital Markets.

Kemp Dolliver: Thank you and good morning. This is based on backing into the numbers and could be off, but Wynzora fees look like they are down sequentially, or just in broad terms barely depressed versus last year’s quarters. Could you talk, A, is that correct, and then B, could you just discuss what’s going on behind that?

John Gay : Yes, so good morning Kemp, this is John. Thanks for your question. The Wynzora piece, keep in mind a couple of things. One, subsequent to the acquisition, the accounting presentation and treatment of Wynzora did evolve a little bit over time, so if you’re looking period over period, there could be some artificial changes. But effectively, the agreement with Wynzora, the way that it works is that–the agreement is that we’re the distributor and commercial partner for MC2 and for that product, so we effectively recognize all the revenue because we get the cash as it relates to the product sales, but we do effectively remit 85%, if you will, back to MC2 because effectively–and we share that as a COGS because effectively that’s the way that this agreement works.

The net-net, if you will, is the residual 15%. As it relates to changes in the fees, quote-unquote, or the part of the MC2 agreement that goes through COGS, that can vary based upon Wynzora and net product revenue, but then again, like I said, we’ve also had some presentation changes during the quarter–or I’m sorry, during the year, I should say.

Kemp Dolliver: Okay, but looking at the underlying script trend, is still a reliable measure of what the fees would be on a normalized basis?

John Gay: Yes.

Kemp Dolliver: Okay, great. Just shifting to Rhofade and the activity there, I think the one question in my mind with regard to how that’s impacting you is I’m assuming–looking at the competitors’ data, it looks like they’re doing the typical thing at a launch – a lot of sampling, very depressed net to gross, and despite the fact you do have rebate agreements in place, you are somehow having to respond. The discussion around coupons in the pharmacy and the like, don’t seem to, you know, may be the adequate, the full explanation to that, but I’m just trying to understand in that context of this initial period of virtually free product out there, if in the final analysis, that just responding to that is what you’re dealing with.

John Donofrio: Yes, this is John Donofrio, I’ll take that. I think you hit a few points in just the gross to net dynamic of payor rebates have increased, not only for new market entrants but also for products on the market, like Rhofade. We continue to still have strong coverage across all the major players that have been with Rhofade for a while, but we have seen increased rebate percentages. I think where the challenge and opportunity is, is still what’s going on at the pharmacy. We’ve seen less scripts being adjudicated through that coverage through numerous reasons, and I think we’ve identified that, we’re working with the payors and the pharmacies to ensure that those scripts that are coming through are not getting rejected and they’re following the business rules and the contractual obligations have been set up.

I think that’s a primary driver of some of the correction you’ve seen, but we continue to see good coverage. As far as our competitors go, really no one competes in the redness market per se. The new products are all still going against anti-inflammatory, and yes, they’ve come out with heavy sampling and heavy discounts. We did mention in my commentary too, Rhofade at this point in its life cycle still has very, very favorable copay card rules, and we’re looking to assess that and ensure that we meet the optimal, that we still have patient affordability, which is still important, but that we can bring optimal value back to Novan, so that’s being assessed as well. As you know, there’s a lot of analogs out there, what that means, and I think we’re very comfortable with some of those opportunities going forward, especially with Rhofade, with the solid writer base that we do have.

Kemp Dolliver: Yes, thank you, and the increased rebate levels, that’s something that’s carrying through in 2023 as part of your annual discussion with the plans? Is that correct?

John Donofrio: Yes, we’re baked for 2023, so we’re already having conversations for 2024. But our contracts go through 2023, so yes, the experience we had in 2022, no changes for 2023 for the rebate percentage.

Kemp Dolliver: Great, thank you.

John Donofrio: You’re welcome, thank you.

Operator: Thank you. The next question comes from John Vandermosten with Zacks.

John Vandermosten: Good morning Paula and John. Regarding gross margin, we saw a lot of volatility in 2022, for a number of reasons that you mentioned. How should we think about it for this year, product gross margin for 2023? Will it be as volatile? Then if we look at kind of the full year percentage there, what way directionally should we think about that going, product gross margin?

John Gay: Thanks John. Sorry – there was a little bit of a breakup, but I think you were asking about the gross margin on a product basis and the volatility we’ve seen, and then what it looks like going forward. Yes, I think–you know, again if you think about it, like I said in the prepared remarks, that margin is impacted by a couple of different things. The true product COGS, if you will, our COGS number–like I said, with royalties and milestones, etc., if you think about true product COGS, that’s going to be a pretty consistent margin, if you will, as it relates to product COGS as a percentage of our gross margin of NPR, net product revenue, so that’s roughly 88% or so, so we would expect that to continue as it relates to the product portion of COGS on a go-forward basis, and where we’ll see some variability will be, again, in the royalties and potential milestones.

John Vandermosten: Great, thank you. When we look at selling, general and administrative, how do we split that between, I guess, sales and marketing and general and administrative for this year?

John Gay: Yes, so if you think about bifurcating, if you will, the SG&A from our commercial business, it was about almost not quite $14 million, and quarter over quarter that spend has stayed–you know, Q4 to Q3 has been kind of relatively consistently. As it relates to what part of that relates to marketing, etc., that has also stayed consistent. Again, as it relates to our activities, I don’t know the exact percentage but I would say it’s fair to say that we expect our G&A as it relates to our–or SG&A, I should say, for the EPI Health business to stay between $4 million and $5 million on a quarterly basis.

John Vandermosten: Okay, and then final question on–you know, if we see approval for SB206, how will that incrementally affect sales and marketing expense as that’s rolled out? I know you have a lot of excess capacity, but there might be some other demands that need to be made. How should we think about that in 2024, assuming approval?

John Gay: Yes, I think there will obviously be some increase, but part of the main benefit of having the acquisition of EPI Health is that it will greatly reduce the amount of marketing spend, quote-unquote, that will be necessary for 206.

Paula Brown Stafford: I was going to say too, the sales, I think stay the same. The marketing might be what increases as we try to market, and as I mentioned earlier, it’s going to be relative to the financing–the funds that we have, how much we are able to market the product ahead or at launch.

John Vandermosten: Great, thank you.

Paula Brown Stafford: Thank you John.

John Gay: Thank you John.

Operator: Thank you. The next question is a follow-up from Oren Livnat with HC Wainwright.

Oren Livnat: Thanks for accommodating the follow-up. You mentioned earlier on the call, John, when discussing R&D that a top priority is certainly progressing to manufacturing activities, so you’re ready to launch if and when the time comes. Can you just talk about in general, what is left to do on that front? Is it just crossing Ts and dotting Is, and manufacturing, keeping things in compliance, or are you going to actually ramp up and build launch quantities ahead of January, and is that in your financial plan?I guess also, just de-risking-wise, are there any things left to do that, in your mind, represent, I guess risk, paths with regards to manufacturing? Are there things that need to be verified still in terms of scale-up or inspection with the FDA? Thanks.

Paula Brown Stafford: Thanks Oren. We are on track for the January PDUFA goal date and the normal course of that standard review. We here are producing in Durham, North Carolina our drug substance and we have submitted what we need to submit, and we are on track. I mean, there are usual processes that you go through in terms of process validation, etc., and so all of that is ongoing, no risks that we are aware of. We continue to progress and want to move toward manufacturing or a potential launch, and in terms of that de-risking and how much do you do ahead of an approval, the midcycle review would come sometime this summer and I think once we get through that, we’d like to be in a position to begin to manufacture product that would be available for a launch. I think John wanted to add–

John Gay: Yes, just to your point as it relates to the cost Oren, obviously anything that we do from preparing for launch in addition to what Paula just mentioned as it relates to product preparedness, that is going to be rolled up into R&D expenses, to my earlier point on an earlier question, which is why we’re going to see effectively the same level of R&D spend next year that we did this year. But to Paula’s point, that amount of cost will be able to get us to a point of the initial launch.

Oren Livnat: Thanks for the clarity.

John Gay: Certainly.

Operator: Thank you. This concludes the question and answer session. I would like to turn the floor to Paula Brown Stafford for any closing comments.

Paula Brown Stafford: Okay, thank you Operator, and thank you all for joining, for really good questions this morning in an extended call. Novan is in a solid position to succeed with this potential launch. We’re on track for our January 5 PDUFA date, so we remain focused and excited for our future. We appreciate you being on the journey with us, so thank you. Have a great day.

Operator: Thank you. The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect your lines.