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spk02: Hello, and welcome to the Novant Incorporated quarterly update conference call and webcast. As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star then zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request, and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risk and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and based on Novant's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements Some of the factors that could cause actual results to differ materially from these contemplated but such forward-looking statements are discussed in the periodic reports NOVAN files with the Securities and Exchange Commission. These documents are made available in the investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies. publications, surveys, and other data obtained from third-party sources, and the company's own estimates and research. While the company believes these third-party sources to be reliable as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified, and any information obtained from third-party sources. Joining us on today's call is the Novant Leadership Team, Ms. Paula Brown-Stafford, Chairman, President, and Chief Executive Officer, Mr. John Gay, Chief Financial Officer, and Mr. Don Ofrio, Chief Operating Officer of Novant and President of EPI Health. I would now like to turn the call over to Ms. Paula Brown-Stafford. Please go ahead.
spk15: Thank you, Chuck. Thank you, Chuck. Good morning, everyone, and thank you for joining our corporate update, including Novant's financial results for the third quarter and year to date. The Novant team remains focused and passionate towards achieving our goals for 2022, and I am very proud of our many accomplishments so far this year. As a reminder, on March 11th, we announced that Novant had closed on our acquisition of EPI Health, providing Novan with commercial infrastructure and commercial revenue. We expanded the depth and breadth of the Novan opportunity to our stakeholders. We have created a medical dermatology company that has the capabilities to discover, develop, and commercialize innovative therapies, bringing medications to patients with diseases of the skin. We have made solid progress since July and have great momentum and focus going into the remaining weeks of 2022. We're pleased to share that we are tracking toward our target submission date, potentially the first FDA-approved treatment for molluscum contagiosum. We are very proud that in the third quarter, the results from our pivotal phase three study, B-simple 4, were published in the JAMA Dermatology Journal authored by Dr. John Browning and others. Also last quarter, we paid off the $16.5 million promissory note with EPG ahead of plan, saving the company nearly $11 million of future expense and no securitization of the company's marketed assets. We've delivered strong volume growth year over year for our promoted prescription products, with total revenue of over $5 million in the third quarter, results for which we are very pleased. And finally, we entered into a non-binding memorandum of understanding with Sato Pharmaceuticals on Friday to potentially market Rofate in Japan and other Asia Pacific territories, representing an important milestone in the execution of our business development strategy. We're driving the company forward. with our development and commercial achievements. Our lead product candidate is Berdasmagel 10.3% or SB206, a potential topical prescription treatment and likely the first FDA approved treatment for molluscum contagiosum. We are progressing our NDA submission for SB206 as planned. We have completed our drug product stability testing necessary for the NDA submission. We are now awaiting our drug substance stability testing and other ongoing analytical testing results. We're targeting the submission of our NDA around the end of 2022, plus or minus a week or so. Just giving ourselves a little room there. Slide seven provides our anticipated timeline based on typical regulatory schedules. So once we submit our NDA, we will await the FDA review of our submission, which is usually approximately 75 days. There, the FDA is filing of our submission while providing a PDUFA date if it is accepted. So a likely PDUFA date is 12 months from our submission date. So during 2023, we anticipate a typical FDA drug review process, and we plan to execute on our pre-launch activities and prepare supply of drug product. And if approved around the end of 2023, we could then commercially launch Ferdasmagel 10.3% in the first half of 2024. As we prepare for our potential launch of Berdasmagel 10.3% for molluscum, we have sponsored a series of market research activities to best prepare for our potential market entry. We have four primary audiences, dermatologists, pediatricians, payers, and the patients, caregivers, and families. With respect to the latter, the majority of patients with molluscum are children, primarily 1 to 14 years of age. So in a recent digital ethnography research study, more than a dozen research participants with molluscum contagiosum were each followed for up to three months. We learned of the negative impacts on the daily lives of sufferers of molluscum. Physical, functional, emotional, social, and on self identity. Physical damage and mental damage can be an outcome of molluscum and or today's molluscum treatments.
spk14: Through a survey
spk15: 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's 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. Then, 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. But 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 Berdasmagel 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. So let's look at one of those potential options. We previously reported robustly positive efficacy results from our pivotal phase three study known as B-simple-4. And as mentioned earlier, recently published in JAMA Dermatology. To our knowledge, B-simple-4 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-simple 4 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 berdazomer gel quite highly. You'll see here 5.1 on a scale of one to seven. And we saw that non-coverage seems unlikely. So 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 D'Onofrio, our Chief Operating Officer and the President of EPI Health, for our commercial update. John?
spk13: Thank you, Paula. Good morning, everyone. I'm pleased to report that our promoted products deliver 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 Rofate and Winsora with a reduction in prescriptions versus previous quarter. However, and importantly, both brands maintained their writer-based levels from previous quarter and continue to deliver strong growth compared to the same quarter last year. An increased commercial focus on our Acme brand Menolera 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 Rofate, we continue to dominate the persistent facial erythema market, boning approximately 90% of the market. Rofate is fast-acting, lasts all day. Improvement persists with regular daily use over 52 weeks. Prescription volume for Rofate in the third quarter came in at 37,900 total prescriptions, representing a 31% growth 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 Rofate for their patients. In fact, Rofate 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 Rofate to treat persistent facial erythema, amongst rosacea patients. Winsora, 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 Winsora 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. when Zora 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, Wenzora managed to finish Q3 with no loss in market share within the topical psoriasis market. We maintained our writer base, and Wenzora 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 Wenzora brings to patients who need and desire quick relief. Our BRO strategy continues to focus on expanding our rider base so more patients can get the benefit of Wenzora. Menolera and oral minocycline for the treatment of acne, offering weight-based flexible dosing and the first-ever bi-phasic 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 Menolera prescriptions during this quarter, as Menolera 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 Menolera 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.
spk15: Thank you, John. So, in summary, we're pleased with our commercial performance. and a quarter that met our internal expectations in terms of total prescriptions. So 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.
spk10: Thank you, Paula. Good morning, everyone. This quarter represents the second quarter in which we have fully consolidated results from our commercial business. I will remind our listeners that when I refer to year-to-date figures, this represents 203 days of commercial activities based on our March 11th 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-day commercial business reported total revenues of $11.2 million. Net product sales of Rofade 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. Rotary 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 30th. We continue to see opportunity for improvement in Winsora, which launched in Q3 of last year. In addition, middle-earth 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-simple IV 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 EPA Health's commercial operations, $4.8 million of transaction-related expenditures related to the EPA Health acquisition, and a $2.3 million increase in investment costs related to the SB206 prelaunch 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 Winsor, 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 SB 206 product candidate and our commercial business. We believe that our cash balance says that September 30th 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 growth aid in Japan. Other potential funding activities may include equity financings, convertible debt, or capital from non-dilutive sources, or traditional debt financing 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'll turn it back to Paula.
spk15: Thank you, John, for providing an update on our financial results and status. We're pleased with Novant'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 and yet a few moving parts towards the final dossier. We are planning for success and preparing ourselves for a potential product launch of Berdasmagel 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 U.S. and are pleased with our opportunity to finalize a license agreement with Sato Pharmaceuticals to potentially market Rofaid in Japan as well as other Asia-packed territories. In closing, the full Novant team remains energetic, focused, and confident in our future path. We appreciate your continued support. Operator, I'm going to now ask and turn the call back to you to facilitate our Q&A session.
spk02: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. And to withdraw your question, please press star then 2.
spk20: And at this time, we'll pause momentarily to assemble our roster. And the first question will come from Jeff Jones with Oppenheimer. Please go ahead. Good morning, guys, and thanks for taking the question.
spk09: I guess a couple of things. In terms of SB 206 and the language used around the 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.
spk15: All right. Thank you, Jeff. I'll take the first on 206, and then I'll have John D'Onofrio discuss the product revenue for fourth quarter. So, is it a concern or is it timing? It is the latter. So 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 so we are partnering and we don't have a concern with the timing. I just want to give ourselves some room if we don't get it at the expected time to be able to put it in the full dossier. Okay. So not a concern with the results, but a concern potentially, you know, with the timing. But we don't think that it would, and that's why I say a week or so is our expectation at this time, if we need that expert.
spk13: Yeah.
spk22: Appreciate it. Thank you.
spk13: Thank you, Jeff, for the morning. And, yes, in regards to Q4, we do not expect seasonality in Q4. And, again, we feel like it's a – rosacea, anseriasis. It's a Q3 dynamic within the summer months. And as we've seen kind of the October, end of October, and what we expect for November and December, we feel confident on the Q4 uptake in seasonality.
spk08: Appreciate that. I guess just one more follow-up question on Sato.
spk09: Is And beyond the MFU program, any other update around the other programs that they have rights in and timing and or financial implications around potential milestones?
spk15: Not any update at this time. They are continuing to pursue SB 206 in Moleskine and are advancing their development program. as expected.
spk21: Thank you.
spk02: Sure.
spk15: Thank you, Jeff.
spk02: Operator? Yes, ma'am. The next question will come from Jennifer Kim with Cancer Fitzgerald. Please go ahead.
spk24: Hey, everyone. Thanks for taking my questions. I have a few here. One is sort of a follow-up on 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. And then related to that, I'm just wondering how your discussions around other territories, how that's going.
spk15: 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. So we will share those terms as soon as we can. But those terms generally include an upfront milestone payment and royalties thereafter. And that would be for Japan and then the right 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. And in terms of other territories, we do have interests and continue to have conversations. As you've seen, and as John's described with Rofate in the U.S., it's a good product, and there is interest in other countries to bring Rofate to market. We have global rights. to Rosade, and it is currently only marketed in the U.S. So it's a product that we see gaining momentum in other territories.
spk23: Okay, that's really helpful.
spk24: My second question is, on Winsora, 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 think if newer topicals are expanding the overall topical market, you maintaining market share means that you're sort of benefiting from that expansion.
spk13: Yes, great question. And, yes, that's what we're seeing. And 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 themselves, You know, it's tough because they're written for multiple things outside of psoriasis, but when you look at the segment, they maintained. And we saw the loss really in the branded and the combination products. So that's where you saw the hit quarter over quarter. But when you look at the overall market, we were able to maintain our market share and our writer base. So, yes, overall to your question. And we've seen that stabilize towards the end of Q3 and in the beginning of Q4. And as we noted, we're excited about new innovation and new entrance into overall medical dermatology, and especially in the psoriasis market on the topical side. And we feel like we're very complementary to the new product entrance. And there was a lot of investment, a lot of resource, and a lot of noise that was, again, very positive for our industry. And I think that as it continues to sort itself out, we will continue to benefit from the growth of the market.
spk24: Okay, great. And then maybe one more quick question on Moleskine. Regarding the analytical testing, is the way that you're thinking about timing based on your latest communications with those third parties?
spk14: It is.
spk15: And 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.
spk24: Okay. And do you anticipate issuing an update once that testing is complete? Or would the next sort of update be the filing?
spk15: Unless we have any issues, the next update will be the filing. So I am feeling good about the next update being a filing.
spk24: Okay, great.
spk03: Thanks, guys. The next question will come from Kim Dolliver with Brookline Capital Markets. Please go ahead.
spk04: Thank you. Good morning.
spk05: First question. As we go into 2023, have you had any consequential changes in your coverage with the health plans?
spk11: Yes. Thank you very much for the question.
spk13: And, you know, we've been able to maintain coverage, our existing coverage that we've contracted for both Rofaid and Menolera. And we will continue to see access to covered lice of about 55 million covered lice on Windsora. So we've been able to maintain the coverage for each of those products heading into 2023. Thank you, Kim. Do you have another?
spk05: Okay. Yes. The other question is on the topic of license agreements. With SB 206, and I'm thinking really specifically EU, are you actively engaged in any discussions there for that product?
spk14: Not at this time, Kemp.
spk15: You know, we are really focused on Rofade 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.
spk04: Great. Thank you.
spk03: The next question will come from John Vandermosen with ZACS.
spk02: Please go ahead.
spk07: Good morning, Paula, John, and John. I 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 think that having the FDA looking at two products that are addressing the same indication provides any benefit or hurdle, perhaps, to approval?
spk15: You know, with the FDA, we don't see it as a hurdle. The FDA has been reviewing our, I want to say, competitor because really Verica 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, again, The FDA is reviewing primarily their contract manufacturing organization, to my knowledge, and I think to everyone's publicly. So 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.
spk07: And then, you know, Verica has had a lot of interactions with the FDA over the last couple of years, you know, with the molestum products. And 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 going to make coming up here in a few weeks or months or so.
spk15: Yeah, we've been focused on our interactions with the FDA, quite frankly. So we've had a number through the last several years and even this year as we prepare to file. We've had ongoing, you know, 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. And so we've been very focused on our submission. So I'm not, I'm really not gleaning anything from theirs other than learning about their CRLs with contract manufacturing. And we are manufacturing here at our facility, our drug substance, and it is Berdazimer only. So it is not competing with any other products in the plant. And then we are using a drug CMO for our drug product. And we've been working with them since 2018, and they have a very good regulatory inspection history. So we have not had those concerns.
spk07: Okay, great. Yeah, things pretty clean on that side of the submission. Last one for me is on SB 206 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 at there to, you know, come up with the appropriate price that will, you know, you know, successfully go into formularies and get your insurance and things like that.
spk15: Right. No, thank you, John, for the question. There really aren't any comparators, so we're just having to look at what we believe the market, you know, and is necessary for, I think John Gay has shared in the filing how much we have previously invested you know, put into the company. I mean, you see a lot of, you know, the averages, it takes a billion dollars 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. But 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 and a thousand dollars a unit. And that is based on our research and payer and pricing strategy.
spk01: Okay, great. That's very helpful.
spk15: Thank you, Paula. Appreciate it. Okay.
spk02: Thank you, Don. This concludes our question and answer session. I would like to turn the conference back over to Ms.
spk03: Paula Brown-Stafford for any closing remarks. Please go ahead.
spk14: Thank you, Operator.
spk15: We made good progress in 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.
spk02: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect. Thank you. Thank you. you Thank you. Thank you. Thank you. you
spk20: Hello and welcome to the Novant Incorporated quarterly update conference call and webcast.
spk02: As a brief reminder, all participants are currently in a listen-only mode. If anyone requires operator assistance during the event, please press star then zero on your telephone keypad. Following the presentation, there will be a question and answer session. Note that this webcast is being recorded at the company's request and a replay will be made available on the company's website following the end of the event. At this time, I'd like to remind our listeners that remarks made during this webcast may state management's intentions, beliefs, expectations, or future projections. These are forward-looking statements and involve risk and uncertainties. Forward-looking statements on this call are made pursuant to the safe harbor provisions of the federal securities laws and based on Novant's current expectations and actual results could differ materially. As a result, you should not place undue reliance on any forward-looking statements Some of the factors that could cause actual results to differ materially from these contemplated but such forward-looking statements are discussed in the periodic reports NOVAN files with the Securities and Exchange Commission. These documents are made available in the investor section of the company's website and on the Securities and Exchange Commission's website. We encourage you to review these documents carefully. Additionally, certain information contained in this webcast relates to or is based on studies. publications, surveys, and other data obtained from third-party sources, and the company's own estimates and research. While the company believes these third-party sources to be reliable as of the date of this presentation, it is not independently verified and makes no representation as to the adequacy, fairness, accuracy, or completeness of or that any independent source has verified, and any information obtained from third-party sources. Joining us on today's call is the Novant Leadership Team, Ms. Paula Brown-Stafford, Chairman, President, and Chief Executive Officer, Mr. John Gay, Chief Financial Officer, and Mr. Don Ofrio, Chief Operating Officer of Novant and President of EPI Health. I would now like to turn the call over to Ms. Paula Brown-Stafford. Please go ahead.
spk15: Thank you, Chuck. Thank you, Chuck. Good morning, everyone, and thank you for joining our corporate update, including Novant's financial results for the third quarter and year to date. The Novant team remains focused and passionate towards achieving our goals for 2022, and I am very proud of our many accomplishments so far this year. As a reminder, on March 11th, we announced that Novant had closed on our acquisition of EPI Health, providing Novan with commercial infrastructure and commercial revenue. We expanded the depth and breadth of the Novan opportunity to our stakeholders. We have created a medical dermatology company that has the capabilities to discover, develop, and commercialize innovative therapies, bringing medications to patients with diseases of the skin. We have made solid progress since July and have great momentum and focus going into the remaining weeks of 2022. We're pleased to share that we are tracking toward our target submission date, potentially the first FDA-approved treatment for molluscum contagiosum. We are very proud that in the third quarter, the results from our pivotal phase three study, B-simple 4, were published in the JAMA Dermatology Journal authored by Dr. John Browning and others. Also last quarter, we paid off the $16.5 million promissory note with EPG ahead of plan, saving the company nearly $11 million of future expense and no securitization of the company's marketed assets. We've delivered strong volume growth year over year for our promoted prescription products, with total revenue of over $5 million in the third quarter, results for which we are very pleased. And finally, we entered into a non-binding memorandum of understanding with Sato Pharmaceuticals on Friday to potentially market Rofate in Japan and other Asia Pacific territories, representing an important milestone in the execution of our business development strategy. We're driving the company forward, with our development and commercial achievements. Our lead product candidate is Berdasmagel 10.3% or SB206, a potential topical prescription treatment and likely the first FDA approved treatment for molluscum contagiosum. We are progressing our NDA submission for SB206 as planned. We have completed our drug product stability testing necessary for the NDA submission. We are now awaiting our drug substance stability testing and other ongoing analytical testing results. We're targeting the submission of our NDA around the end of 2022, plus or minus a week or so. Just giving ourselves a little room there. Slide seven provides our anticipated timeline based on typical regulatory schedules. So once we submit our NDA, we will await the FDA review of our submission, which is usually approximately 75 days. There, the FDA is filing of our submission while providing a PDUFA date if it is accepted. So a likely PDUFA date is 12 months from our submission date. So during 2023, we anticipate a typical FDA drug review process, and we plan to execute on our pre-launch activities and prepare supply of drug product. And if approved around the end of 2023, we could then commercially launch Ferdasmagel 10.3% in the first half of 2024. As we prepare for our potential launch of Berdasmagel 10.3% for molluscum, we have sponsored a series of market research activities to best prepare for our potential market entry. We have four primary audiences, dermatologists, pediatricians, payers, and the patients, caregivers, and families. With respect to the latter, the majority of patients with molluscum are children, primarily 1 to 14 years of age. So in a recent digital ethnography research study, more than a dozen research participants with molluscum contagiosum were each followed for up to three months. We learned of the negative impacts on the daily lives of sufferers of molluscum, physical, functional, emotional, social, and on self-identity. Physical damage and mental damage can be an outcome of molluscum and or today's molluscum treatments.
spk14: Through a survey
spk15: 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's 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. Then, 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. But 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 Berdasmagel 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. So let's look at one of those potential options. We previously reported robustly positive efficacy results from our pivotal phase three study known as B-simple-4. And as mentioned earlier, recently published in JAMA Dermatology. To our knowledge, B-simple-4 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-simple 4 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 berdazomer gel quite highly. You'll see here 5.1 on a scale of one to seven. And we saw that non-coverage seems unlikely. So 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 D'Onofrio, our Chief Operating Officer and the President of EPI Health, for our commercial update. John?
spk13: 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 Rofate and Winsora with a reduction in prescriptions versus previous quarter. However, and importantly, both brands maintained their writer-based levels from previous quarter and continue to deliver strong growth compared to the same quarter last year. An increased commercial focus on our Acme brand Menolera 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 Rofate, we continue to dominate the persistent facial erythema market, boning approximately 90% of the market. Rofate is fact-acting, lasts all day. Improvement persists with regular daily use over 52 weeks. Prescription volume for Rofate in the third quarter came in at 37,900 total prescriptions, representing a 31% growth 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 Rofate for their patients. In fact, Rofate 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 Rofate to treat persistent facial erythema, amongst rosacea patients. Winsora, 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 Winsora 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. when Zora 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, Wenzora managed to finish Q3 with no loss in market share within the topical psoriasis market. We maintained our writer base, and Wenzora 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 Wenzora brings to patients who need and desire quick relief. Our BRO strategy continues to focus on expanding our rider base so more patients can get the benefit of Wenzora. Menolera and oral minocycline for the treatment of acne, offering weight-based flexible dosing and the first-ever bi-phasic 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 Menolera prescriptions during this quarter, as Menolera 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 Menolera 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.
spk15: Thank you, John. So, in summary, we're pleased with our commercial performance. and a quarter that met our internal expectations in terms of total prescriptions. So 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?
spk10: Thank you, Paula. Good morning, everyone. This quarter represents the second quarter in which we have fully consolidated results from our commercial business. I will remind our listeners that when I refer to year-to-date figures, this represents 203 days of commercial activities based on our March 11th 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-day commercial business reported total revenues of $11.2 million. Net product sales of Rofade included in our commercial businesses' total revenue was $8.6 million, with other products in our portfolio contributing $2.6 million year-to-date. Rotary 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 30th. We continue to see opportunity for improvement in Winsora, which launched in Q3 of last year. In addition, middle-earth 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-simple IV 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 EPA Health's commercial operations, $4.8 million of transaction-related expenditures related to the EPA Health acquisition, and a $2.3 million increase in investment costs related to the SB206 prelaunch 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 Winsor, 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 says that September 30th 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 networking 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 growth aid in Japan. Other potential funding activities may include equity financings, convertible debt, or capital from non-dilutive sources, or traditional debt financing 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'll turn it back to Paula.
spk15: Thank you, John, for providing an update on our financial results and status. We're pleased with Novant'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 and yet a few moving parts towards the final dossier. We are planning for success and preparing ourselves for a potential product launch of Berdasmagel 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 U.S. and are pleased with our opportunity to finalize a license agreement with Sato Pharmaceuticals to potentially market Rofaid in Japan as well as other Asia-packed territories. In closing, the full Novant team remains energetic, focused, and confident in our future path. We appreciate your continued support. Operator, I'm going to now ask and turn the call back to you to facilitate our Q&A session.
spk02: Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. And to withdraw your question, please press star then 2.
spk20: And at this time, we'll pause momentarily to assemble our roster. And the first question will come from Jeff Jones with Oppenheimer. Please go ahead. Good morning, guys, and thanks for taking the question.
spk09: I guess a couple of things. In terms of SB 206 and the language used around the 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.
spk15: All right. Thank you, Jeff. I'll take the first on 206, and then I'll have John D'Onofrio discuss the product revenue for fourth quarter. So, is it a concern or is it timing? It is the latter. So 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 so we are partnering and we don't have a concern with the timing. I just want to give ourselves some room if we don't get it at the expected time to be able to put it in the full dossier. Okay. So not a concern with the results, but a concern potentially, you know, with the timing. But we don't think that it would. And that's why I say a week or so is our expectation at this time. If we need that expert. Yeah.
spk22: Appreciate it. Thank you.
spk13: Thank you, Jeff. Good morning. And yes, in regards to Q4, we do not expect seasonality in Q4. And again, we feel like it's a... rosacea, anseriasis. It's a Q3 dynamic within the summer months. And as we've seen kind of the October, end of October, and what we expect for November and December, we feel confident on the Q4 uptake in seasonality.
spk08: Appreciate that. I guess just one more follow-up question on Sato.
spk09: Is the And beyond the MFU program, any other update around the other programs that they have rights in and timing and or financial implications around potential milestones?
spk15: Not any update at this time. They are continuing to pursue SB 206 in Moleskine and are advancing their development program. as expected.
spk21: Thank you.
spk02: Sure. Thank you, Jeff. Operator? Yes, ma'am. The next question will come from Jennifer Kim with Cancer Fitzgerald. Please go ahead.
spk24: Hey, everyone. Thanks for taking my questions. I have a few here. One is sort of a follow-up on the last question. The Memorandum of Understanding with SADO, 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. And then related to that, I'm just wondering how your discussions around other territories, how that's going.
spk15: 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. So we will share those terms as soon as we can. But those terms generally include an upfront milestone payment and royalties thereafter. And that would be for Japan and then the right 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. And in terms of other territories, we do have interests and continue to have conversations. As you've seen, and as John's described with Rofate in the U.S., it's a good product, and there is interest in other countries to bring Rofate to market. We have global rights. to Rosade, and it is currently only marketed in the U.S. So it's a product that we see gaining momentum in other territories.
spk23: Okay, that's really helpful.
spk24: My second question is, on Winsora, 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 think if newer topicals are expanding the overall topical market, you maintaining market share means that you're sort of benefiting from that expansion.
spk13: Yes, great question. And, yes, that's what we're seeing. And 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 themselves, You know, it's tough because they're written for multiple things outside of psoriasis, but when you look at the segment, they maintained. And we saw the loss really in the branded and the combination products. So that's where you saw the hit quarter over quarter. But when you look at the overall market, we were able to maintain our market share and our writer base. So, yes, overall to your question. And we've seen that stabilize towards the end of Q3 and in the beginning of Q4. And as we noted, we're excited about new innovation and new entrance into overall medical dermatology, and especially in the psoriasis market on the topical side. And we feel like we're very complementary to the new product entrance. And there was a lot of investment, a lot of resource, and a lot of noise that was, again, very positive for our industry. And I think that as it continues to sort itself out, we will continue to benefit from the growth of the market.
spk24: Okay, great. And then maybe one more quick question on Moleskine. Regarding the analytical testing, is the way that you're thinking about timing based on your latest communications with those third parties?
spk14: It is.
spk15: And 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.
spk24: Okay. And do you anticipate issuing an update once that testing is complete? Or would the next sort of update be the filing?
spk15: Unless we have any issues, the next update will be the filing. So I am feeling good about the next update being a filing.
spk24: Okay, great.
spk03: Thanks, guys. The next question will come from Kim Dolliver with Brookline Capital Markets. Please go ahead.
spk05: Thank you. Good morning. First question. As we go into 2023, have you had any consequential changes in your coverage with the health plans?
spk11: Yes. Thank you very much for the question.
spk13: And, you know, we've been able to maintain coverage, our existing coverage that we've contracted for both Rofaid and Menolera. And we will continue to see access to covered lights of about 55 million covered lights on Windsor. So we've been able to maintain the coverage for each of those products heading into 2023. Thank you, Kim. Do you have another?
spk05: Okay. Yes. The other question is on the topic of license agreements. With SB 206, and I'm thinking really specifically EU, are you actively engaged in any discussions there with that product?
spk14: Not at this time, Kemp.
spk15: You know, we are really focused on Rofaid 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.
spk04: Great. Thank you.
spk02: The next question will come from John Vandermosen with ZACS. Please go ahead.
spk07: Good morning, Paula, John, and John. I 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 think that having the FDA looking at two products that are addressing the same indication provides any benefit or hurdle, perhaps, to approval?
spk15: You know, with the FDA, we don't see it as a hurdle. The FDA has been reviewing our, I want to say, competitor because really Verica 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 publicly. So, 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.
spk07: And then, you know, Verica has had a lot of interactions with the FDA over the last couple of years, you know, with the molestum products. And 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 going to make coming up here in a few weeks or a month or so.
spk15: Yeah, we've been focused on our interactions with the FDA, quite frankly. So we've had a number through the last several years and even this year as we prepare to file. We've had ongoing, you know, 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. And so we've been very focused on our submission. So I'm not, I'm really not gleaning anything from theirs other than learning about their CRLs with contract manufacturing. And we are manufacturing here at our facility, our drug substance, and it is Berdazimer only. So it is not competing with any other products in the plant. And then we are using a drug CMO for our drug product. And we've been working with them since 2018, and they have a very good regulatory inspection history. So, we have not had those concerns.
spk07: Okay, great. Yeah, things are pretty clean on that side of the submission. Last one for me is on SB 206 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 at there to, you know, come up with the appropriate price that will, you know, you know, successfully go into formularies and get your insurance and things like that.
spk15: 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 invested you know, put into the company. I mean, you see a lot of, you know, the averages, it takes a billion dollars 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. But 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 and a thousand dollars a unit. And that is based on our research and payer and pricing strategy.
spk01: Okay, great. That's very helpful.
spk15: Thank you, Paula. Appreciate it. Okay.
spk02: Thank you, John. This concludes our question and answer session. I would like to turn the conference back over to Ms.
spk03: Paula Brown-Stafford for any closing remarks. Please go ahead.
spk14: Thank you, Operator.
spk15: We made good progress in 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.
spk02: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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