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spk09: Welcome to the conference call hosted by DARE Bioscience to review the company's financial results for the quarter ended March 31st, 2023 and to provide a general business update. This call is being recorded. My name is Mallory and I will be your operator today. With us today are Sabrina Martucci Johnson, DARA's President and Chief Executive Officer, John Fair, DARA's Chief Commercial Officer, and Lisa Walters-Hoffert, DARA's Chief Financial Officer. Ms. Johnson, please proceed.
spk05: Thank you. Good afternoon and welcome to the financial results and business update call for the quarter ended March 31st, 2023 for DARI Bioscience. Our plan today is to review our first quarter results, discuss development since our recent call in March, and highlight some important objectives and milestones anticipated in 2023. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by the statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31, 2023, which was filed today. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, March 11, May 11, 2023. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As a reminder, DARI's diversified portfolio, which includes one FDA-approved product and 12 development stage candidates, three of which are in or nearing Phase III clinical development, is focused solely and squarely on women's health and is built upon the following core principles. Each product candidate must address a meaningful market opportunity in the form of a persistent unmet need. Each product candidate must have the potential to be first line or first in category or both because we seek to deliver a clear improvement over the standard of care. And ideally, each product candidate has demonstrated proof of concept and or uses well-characterized active pharmaceutical ingredients which can mitigate development time, cost, and even risk. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. On our recent 2022 financial results and update call, we discussed the key milestones anticipated for the year 2023. Phase 2B RESPOND studied top-line results for our investigational sidenafil cream for female sexual arousal disorder. the U.S. launch of Xaxiado by Organon, the initiation of the Phase III clinical study of Oviprene, our investigational potential first-in-category hormone-free monthly intravaginal contraceptive, whose U.S. commercial rights are under a license agreement with Bayer, which we expect will be the single pivotal study to support Oviprene's premarket application. IND-related activities for DER-HRT1, which is our investigational 28-day intravaginal ring for hormone therapy for the vasomotor symptoms of menopause, and IND-related activities for DER-VVA1, our investigational hormone-free intravaginally administered treatment for vulva and vaginal atrophy, as well as our Phase III-related clinical study plans for the candidate DER-HRT1 and Phase II clinical study plans for DER-VVA1. And additionally, DARE PDM-1, which is our investigational vaginal hydrogel formulation of diclofenac to treat primary dysmenorrhea or menstrual cramps, the phase one study conduct, and the topline data this year. On today's call, Lisa will review our first quarter 2023 financial results shortly. But we will otherwise focus on our anticipated milestones for this quarter, this second quarter of 2023. So, mainly, we'll spend our time today on the Sidenafil-CREME 3.6% phase-to-be response study top-line results and the commercial launch of Zosciato in the U.S. by Organon. We'll start with the Sidenafil-CREME update, and we will review both the exploratory phase-to-be response study objectives to provide context for the anticipated upcoming top-line data readout, And as importantly, we'll talk about the market dynamics for female sexual arousal disorder, which will highlight why we're so excited to be conducting this Phase 2B study for this yet-unserved indication that's analogous to erectile dysfunction in men. I'll then turn the call over to John, who will provide an update on Organon's Ashiado launch activities. With sildenafil cream, 3.6%, we're looking to address the lack of physical genital arousal response and sensations and the associated distress that are the hallmark of female sexual arousal disorder or FSAD. As I mentioned up front, FSAD is analogous to erectile dysfunction or ED in men. Both in terms of the pathophysiology of the condition as well as the target pharmacology, and the addressable markets are also quite comparable in size. As we approach the Phase IIb top-line data readout expected this quarter, we wanted to give you a sense of what you can expect. First, by way of refresher, previously conducted studies by DARE and our licensor, SST, demonstrated that this cream formulation of sidenafil, which is the same active ingredient as in Viagra, increased blood flow to the female genital tissue, both when assessed via an internal vaginal probe and when assessed via an external temperature sensing camera. These data provide the proof of concept that the formulation is achieving its target activity in the tissue, increasing blood flow. Obviously, vaginal probes and general temperature sensors are not practical endpoints for a Phase III program. Thus, the exploratory Phase 2b study was designed to evaluate the performance of the sidenafil cream and to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements, which are referred to as patient-reported outcomes, in their at-home setting. So this way, we could identify and select the appropriate patient-reported outcomes to take forward into the Phase 3 program. So that's where we're expecting in the Phase 2B readout. So as we wait for the Phase 2B respond data readout, it's a great time to also remind everyone why we're so excited about the FSAD opportunity. We've mentioned on numerous calls that it's our belief that the FSAD market could be as large or larger in terms of potential patients as the ED market. We've also mentioned that our product candidates, the NFL Cream 3.6%, is the only development stage program to our knowledge that is specifically designed to address the lack of genital arousal symptoms associated with FSA-D. As I mentioned, sidenafil is the active ingredient in Viagra, and our innovative topical cream formulation for women is designed to be used on demand prior to sexual activity and to deliver sidenafil directly to the genital tissue to facilitate vasodilation and increase blood flow directly where needed to improve the physical arousal response to address the lack of those genital arousal sensations commonly associated with FSAD. So, sidenafil cream has the potential to be the first FDA-approved product to treat FSAD and create an entirely new market of comparable addressable market size as ED. To put some of the market dynamics into context, We only need to look back to the launch of Viagra in 1998. According to an article published at that time in CNN Money, there were 2.7 million prescriptions filled for Viagra in its first full quarter on the market. And at that time, that was the most prescriptions ever for any pharmaceutical product in its first quarter on the market. According to the same source, more than 160,000 physicians prescribed the product during that period of time. making it one of the most successful product launches in history and helping to double Pfizer's market cap. It can be challenging to be first as a drug developer, blazing a new path as we are with our exploratory phase 2b study, where, as I mentioned, we need to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements in order to identify and select the appropriate patient-reported outcomes to take forward into the Phase III program. But that level of uptake that I described in the Viagra launch from both providers and patients is incredibly impressive. And we see a number of similarities between ED and FSAD markets. So principally in ED, a lack of viable pharmaceutical intervention created a situation where before Viagra, men had a significant condition which often led to depression, isolation, and frustration. As is now the case with women with FSAD, without a viable intervention for ED like Viagra, men were reluctant to have a conversation or ask their provider for help or information. According to a 2004 study conducted by the British Medical Journal, The authors noted that men reported that ED affected their personal relationships, often left them feeling embarrassed, and they generally suffered in silence, as many men felt unable to talk to their partners or friends about their condition. The authors also noted that once Viagra became available and when it provided symptom relief, men reported feeling happy and elated, as well as great improvements in their well-being. These findings mirror the insights that we have uncovered about FSAD. We know that women are similarly reluctant to speak about their condition with their partners and often report feeling dissatisfaction with their sex lives, unhappiness, and general frustration due to their sexual problems. We also believe that without an FDA-approved intervention, women are left alone to suffer in silence and are often affected by a feeling of shame or embarrassment. Given the similarities of ED and FSAD in terms of the pathophysiology of the condition, as well as the psychological and emotional impact that we've been discussing, we believe there is enormous unmet need, and we see the potential for a large amount of pent-up demand for a product like sildenafil cream. Therefore, we're excited to bring our exploratory Phase IIb study to conclusion. This quarter, we plan as the first step to report the top line data for a number of the assessment tools that we utilized in the study. Subsequent to reporting the top line results, when we have the full data set from the study, we will formalize our proposals to the FDA regarding the patient population to study and the endpoints to evaluate in the Phase III program. In addition to the Phase IIb study where the product was used at home, We recently announced the initiation of a supplemental thermography study in a clinical setting. This phase one thermography study of sidenafil cream is expected to enroll around 15 women and to be completed this year. These data are an important part of our comprehensive clinical development and regulatory plan for sidenafil cream, and they'll add to our existing clinical and non-clinical data package to support the ongoing development program. These data are expected to complement the forthcoming clinical findings from our Phase 2B RESPOND trial in preparation for a Phase 3 program. Our goal is to bring a much needed solution to the women, estimated to be 10 million in the United States alone, who are distressed and seek treatment for low or no sexual arousal, and with no FDA approved option to address their condition, Our goal is for sedentafil cream to be the first FDA-approved product for women with FSAD as Viagra was for men with ED. Now, we're not planning on providing detailed updates on the other development programs today, but I do want to note that we've been enjoying working with our collaborator, NICHD of the NIH, on the oviprene pivotal study start plan for later this year. And we continue to expect to commence patient enrollment in mid-2023, and what we expect to be the single pivotal contraceptive clinical study required to support the PMA submission for registration. I also want to mention that we are thrilled with the interest in our DARE PDM-1 study that is underway in Australia. As a reminder, this is our investigational product to treat primary dysmenorrhea or menstrual cramps. by delivering the non-steroidal anti-inflammatory drug diclofenac vaginally, using our proprietary hydrogel formulation, that same formulation technology that is used in Zosciato. The top-line data are expected this year, and recent market research suggests that the global market for dysmenorrhea treatment was estimated to be valued at $13 billion in 2022, and that the size of this market is expected to increase to $28 billion by 2029. So with those updates on the development programs, I will now turn it over to John to provide a commercial update on the Zosciato launch activities.
spk02: Thank you, Sabrina. As a reminder, Zosciato clindamycin phosphate vaginal gel is a lincosamide antibacterial for single-dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older in the United States. The Zasciato story is great validation of our portfolio candidate selection and development strategy. Bacterial vaginosis is the most common vaginal condition in women of reproductive age, estimated to affect approximately 23 million women in the US alone. However, a large number of women with the condition are underserved by currently available products. We believe that we could deliver a novel option. Understanding that differentiation drives value We designed a phase three study capable of generating the data necessary to support a compelling label. We believe that if we were successful in our clinical development planning, we would be able to create an opportunity for commercialization collaboration that could drive value. And in regard to securing a collaborator capable of maximizing value, we believe we have been very successful. We are thrilled that the women's health company Organon is launching Zasciato, and that they will leverage their established Nexplanon sales team to accelerate Zasciato uptake. With the manufacturing validation activities required to support the commercial launch completed, commercial launch activities are progressing. Given that the sales team for Nexplanon will be launching Zasciato, we expect that Zasciato will benefit from Organon's track record of commercial success in the branded women's health category. Organon believes there's a roughly 90% overlap of healthcare providers or HCPs who prescribe Nexplanon and have the potential to be prescribers of Zosciato based on provider treatment patterns. Because of the strong relationships the sales team has with these HCPs in the women's health space, we expect Organon to be well positioned to inform these HCPs about Zosciato, ultimately providing benefits for their patients. As I mentioned on our last update call, Organon has what we believe to be a truly integrated go-to-market plan targeting all of the key stakeholders, HCPs, payers, and patients in order to quickly drive interest and awareness in Zasciato. With a strong product label and a powerful commercial partner, we are excited about the launch of Zasciato expected this quarter. And Organon has been working on launch activities. They're taking a holistic approach to the product's introduction including ongoing work in the areas of non-Salesforce-related promotional activities and utilization of key symposia and conference events. Organon had a very prominent presence at a recent payer-focused industry conference called AMCP, which stands for the Academy of Managed Care Pharmacy. This annual event is one of the key conferences where payers and manufacturers can interact and share key pharmacoeconomic insights and learnings across a broad range of products therapeutic areas. Organon shared important insights into the pharmacoeconomic and socioeconomic impact of a bacterial vaginosis diagnosis and I attended this conference personally and I really believe this information was very well received by many of the key stakeholders attending the conference as well. In addition to their presence at AMCP and their ongoing work with payers, Organon is planning activities in support of the physician community including their branded exhibit at the Marquee Conference in Women's Health and the American College of Obstetricians and Gynecologists annual clinical and scientific meeting, commonly referred to in our field as the ACOG meeting. The upcoming ACOG meeting, which takes place later this month, provides unique opportunities to interact with key HCPs focused in women's health, which is critical given the role that OBGYN offices play in treating patients with bacterial vaginosis. And finally, I know we touched on this earlier, but I feel it's worth repeating, Organon will leverage its established Nexplanon sales team which currently focuses on contraception to maximize Zasciato uptake at launch. And because the vast majority of sufferers of bacterial vaginosis are also women of reproductive age, the Nexplanon sales force is well-positioned to leverage their existing relationships with HCPs in women's health. So in summary, we believe that Zasciato should be well-positioned for commercial success, given the knowledge and experience of Organon's Nexplanon sales team, coupled with Organon's payer outreach provider and patient-centered initiatives. We are working towards the first commercial sale before the end of the second quarter. And with that, I will now turn the call over to Lisa to provide a financial update.
spk01: Thank you, John, and thanks, everyone, for joining us today. I would now like to summarize DARI's financial results for the quarter ended March 31, 2023, which I will refer to as the current quarter or first quarter. As you know, DARI's business model is to assemble in advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health, and then to monetize the value of our portfolio's clinical and regulatory advances over both the near and long term. The investment required to build and advance a portfolio include corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development, or R&D, expenses. So during the first quarter of 2023, our general and administrative expenses, or G&A, were approximately $3.3 million. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately $5 million, and primarily reflected the costs of two of our later stage programs, including the ongoing sildenafil cream 3.6% phase 2B respond clinical trial and manufacturing and regulatory affairs activities related to overprint. Our comprehensive loss for the quarter was approximately $8 million. We ended the first quarter with approximately $19.8 million in cash-in-cash equivalents, and we had approximately 86.3 million shares of common stock outstanding as of May 10th. In terms of upcoming milestones and future sources of cash, under our license agreement with Organon to commercialize Zasciato, we are entitled to receive $2.5 million following first commercial sale. Thereafter, we will be eligible to receive potential additional milestone payments of up to $180 million as well as tiered double-digit royalties based on Sociato's net sales. We are continuing to explore a variety of options to fund our operations, advance our candidates, monetize the value of our assets, and build shareholder value. As a reminder, these alternatives include, but are not limited to, non-dilutive grants, equity sales, license agreements, structured financings, strategic collaborations and alliances. As we've noted previously, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and build shareholder value. We also encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended March 31, 2023, which we filed this afternoon. as well as our annual report on Form 10-K for the year ended December 31st, 2022, which was filed on March 30th, 2023. I would now like to turn the call back over to Mallory, the operator.
spk09: Thank you for attending the conference call. At this time, if you would like to ask a question, please press star followed by the number one on your telephone keypad. Your first question comes from the line of Catherine Novak with Jones Research.
spk03: Hi. Good afternoon. Congrats on the quarter, and thank you so much for taking my question. My first question is about sildenafil cream. Just thinking about the response study, you know, what kind of, Endpoints are important for efficacy study that's specifically directed at arousal. And to that point, how are arousal and desire differentiated from the FDA's perspective, you know, when you're thinking about a product that's directed specifically at FSAD versus hypoactive desire?
spk05: Great questions. Thank you for them. And it's a good reminder of some of the things that maybe we should have also talked about in our prepared comments, because they're great questions to kind of get everyone ready right for the day to read out. So in terms of the kind of questions that one can ask about general sensations of arousal, they are... concussive as the name implies, they're questions about what someone might be feeling, right, literally a sensation, a physical sensation, as part of their sexual activity and part of that arousal response to activity. And you may remember that, and we've talked about this on past calls, that we utilize both a combination of already validated questionnaires about sexual functioning that have a lot of domains, questions about orgasm, questions about lubrication, questions about arousal sensations, questions about cognition even, right, and questions about desire, right, things that you talked about. So we used some of the kind of relevant parts of some validated questionnaires like that, and then we also included what we're referring to as our exploratory endpoints, and those really came out of interviews with women who have the condition to understand what bothers them, what are they not feeling physically, what are the words they use to describe it, and what would they like to see improved. And so those are the type of things that we included in our study. And to your question, too, about the difference between those kind of questions versus desire disorder, You know, think about what sildenafil does. Sildenafil increases blood flow, right? That is what it does, right, through its mechanism. And so we're really focusing on questions about what sildenafil does and what someone is likely going to feel as a result of that. And that's very different from desire. Desire is interest, right? It's emotional. It's are you interested in having a sexual activity? Do you have sexual fantasies? It's more that thought aspect of it. And so we do ask questions about that in the trial, because I think it's important for us to understand our patients, both the subjects in the study, but before we enroll them in the study, and to understand all the benefits that a product like Sidenafil could potentially have. But the focus is really on those general sensations, those physical manifestations. as opposed to how interested they are or how much they fantasize.
spk03: Right, that's helpful. My understanding, FDA does not have separate draft guidances for arousal and benign disorders. They're kind of lumped together.
spk05: Yeah, so what they did, it's one guidance document, but it is very, very clear that the conditions are So what they've done is they have one guidance document that covers both as discrete conditions, female sexual arousal disorder and hypoactive desire disorder, but they are all part of one guidance document. And I think part of that came out of the fact that the desire products, there are two products now FDA approved for desire disorder. They came before us in terms of approaching the FDA and talking about studies and talking about indications that really led to ultimately the FDA putting out that draft guidance document in 2016 to very clearly try to distinguish the two disorders. They are different, and they certainly don't want, for instance, a product that only demonstrates improvement in one aspect. like desire to get labeling to imply that they improve arousal, because those are two very different things. And so that's what the guidance document was really intended to do, was to spell out they're both aspects of sexual dysfunction, but they're different, and to give examples for sponsors on what the pathway to approval is. And it gives a lot of leeway. That's why we did all this work to align on our exploratory endpoints and align with the FDA that the Phase 2B really is the validation study for those exploratory endpoints so that we really have an opportunity to take the best, most responsive questions forward into the Phase 3.
spk03: Got it. No, that's helpful. Thanks again and congrats on the quarter.
spk05: Thank you so much. And maybe one other point on that too that might be helpful to just, again, help frame it for people that are going to be watching for the top line data. In any clinical trial, your primary outcome measures that you declare as the primary, they have to be, if you're using a patient-reported outcome, it has to be an already validated questionnaire. So we were not able to use some of the questions, those very specific questions that women with the condition helped us develop. We were not able to use any of those as our primary or secondary endpoints. So those are all our exploratory endpoints. So the primary endpoint really came out of an already validated questionnaire, a sexual function questionnaire of 28 questions, and then we use this particular arousal domain of it. And then an already established and validated questionnaire around around distress and we use one question out of that. So that's how we came up with the primary endpoints using those already validated questionnaires. And then the exploratory endpoints use all of the new questions and new way of asking the questions and new descriptive words that came out of our patient interviews. Those are our exploratory endpoints. And that's why our top line data readout will be a little A traditional top-line data readout usually just has the primary endpoint, but these exploratory endpoints are just as interesting. We can't do all of it for the top-line data readout because that would just be a little bit much to do quickly, which is why we made the comment that we'll end up having to look at the whole Folsom database before we can decide what goes into phase three, but at least for top-line, we'll be able to share a combination of both the primary, secondary, as well as some of these exploratory endpoints. It's the fun of being first.
spk09: Your next question comes from Kumar Raja with Roth Capital.
spk06: Thanks for taking my questions, and congratulations on the progress. Continuing with the sealed Denafil cream, What is the expectation in terms of when you will have the full data set?
spk05: That's a great question. You know, we are trying to work as quickly as we can, right? So as you know, the way the process works is you have the database lock and then there's, you know, we'll fairly quickly in short order from that have the top line data, which obviously we will announce very quickly upon getting those top line data. But then typically it does take, you know, we're not talking days. It's more time, right, you know, before you actually get the full, the complete data set and really have an opportunity to go through all of it very carefully and ultimately compile your clinical study report. That, as you, you know, probably well know from other corporate experiences, you know, can take weeks to months. for that to happen. So obviously, we're motivated to work very quickly. It's something we pride ourselves on in terms of being a smaller company. You can work quickly, but this is a very rich data set. I cannot stress that enough. We are asking these women who participated in the study, they were asked a lot of different questions, a lot of different ways, a lot of different times, and we collect a lot of information about them. And so we don't want to rush this analysis because we are going to blaze the path, right, hopefully for the phase three and what's going to happen in phase three, and not just for us, but who comes potentially after us. And a program like this, if it's successful, as we hope it can be, we want to make sure that what we request from the FDA in the phase three is very, our formulation favorable as well, right? That's a long way of me saying it's going to take some time. Know that the time is thoughtful and purposeful and well spent with the shared objective of making sure we take something forward ultimately to the FDA. Obviously, as quickly as we can. We want to move the data as we hope. We want to move this forward as fast as we possibly can. But we also know you get that one opportunity to present this to the FDA and what we want to take forward. So we're going to want to make sure we're thoughtful in that.
spk06: Okay. And with regarding to the thermography study, how many sites will you be conducting that study in? And how will that be kind of like, you know, viewed in with this complete data before you present it to the FDA?
spk05: Yeah, so great question. So it's one site that we're working with. And, you know, these studies are very specific in their conduct. So there are only actually in the whole world less than a handful of sites that can do these kind of sexual health thermography studies because they're very specific in terms of the type of equipment you use, in terms of the type of setup you need to have in order to do the study, and the conduct. So we worked with one site for the first thermography study that we did, and we're working with one of the other sites that has the capacity to do this for this particular study. And what they can be very helpful in is helping you understand time to effect and what that time to effect curve looks like. Obviously, we did one of them purposely before the phase 2B study, and that's what determined our dosing regimen. And in the phase 2B, we gave a window of 10 to 20 minutes when the woman would need to dose the product in advance of a sexual activity. So having some additional data around that is very helpful and also data in terms of you know, how quickly it separates from placebo is very helpful for us. And, you know, so we had that great, some of that great data going into the Phase IIb, but, you know, we think it's very powerful to have a more fulsome data set, you know, again on that, you know, as we prepare for discussions with the FDA for the ultimate Phase III plan. But that's what we're really looking at. You know, we're looking at, you know, what is the placebo curve and vehicle curve and active curve? You know, what is the no product, right? What does that all look like? And what is that time when you're seeing kind of that maximum separation so that as we plan our go-forward program, we're really making sure we're taking a lot of very specific data into consideration. Okay, that's great.
spk06: And maybe finally, in terms of ovoprene, maybe just provide some highlights. Like, is everything going as expected for the mid-23 trial start?
spk05: Yeah. No, we're super excited. So the NICHD has been fantastic to work with. They started doing work and prepping, you know, the core sites that we're going to have in the study, which are part of their contraceptive clinical trials network, you may remember, back in December of last year. which was super helpful because, you know, they also gave great kind of insights on the protocol in terms of operationally in conduct. And then, you know, obviously manufacturing activities, as Lisa talked about, in terms of, you know, things we've been spending on, obviously, you know, pivotal study supplies, right, all of that, which is important to have for the study. So things have been shaping up nicely. You know, as you know, part of the time we have said was also, you know, you know, regulatory time. You may remember that the ID approval from the FDA came with some comments and things that, you know, wanted to comment on things we might want to consider for the pivotal study to help really make sure it's that one pivotal study for registration. So we've been working on all of that and are feeling really good about where we are now and the site's excitement and enthusiasm for the study, as well as, you know, the NIH's you know, enthusiasm for working with us on that. So, you know, we're feeling like we're in really good shape and everything's moving forward as planned right now.
spk06: Okay, great. Thanks so much. Yep.
spk09: Your next question comes from the line of Kemp Dolliver with Brookline Capital.
spk07: Good afternoon. I'm going to ask about Zaciano and
spk05: The context of the question.
spk07: Yes. So, so excuse me, you, your milestones dependent upon, you know, the first commercial sale, which is a pretty low bar in the grand scheme of things. And I have, you know, you, it does appear to be getting some formulary coverage and, and I think the real heart of my question is, given all this talk about launch and the fact that you haven't, say, aren't saying that you've had the first sale yet, that tells me that there's a question about the timing of when Organon's actually detailing it. Have they started detailing the product? Yeah, it's a great question for us to answer.
spk05: Yeah, it's a great question for us to clarify. So as John mentioned, right, in his comments, there's, and we've been talking about, right, and as you just noted, right, in terms of formulary and payer and all that, there are activities that started last year, frankly, right, around, you know, those activities that we would all characterize as launch activities, right? So launch activities have been underway. Obviously, there is a big, important marquee conference, as John noted, in the women's health space happening in May. As John also noted, and we've mentioned on past calls, there were manufacturing validation activities that had to happen before you could put product in the channel. With the manufacturing validation activities required to support that commercial launch now completed, you know, that really allows us into that next phase of the commercial launch activities that, you know, to your point, achieve that low bar of that first commercial sale. And, you know, and that's why we're guiding that with everything that's happening with, obviously, ACOG being a very important, you know, big branded company. right? Branded exhibit event, um, for this product. Obviously that's happening this month, you know, in May, that's what we're saying. Look, you know, the anticipation is, is second quarter.
spk07: Okay. Super. And the, the product is in licensed and I think you have to share the economics, uh, with the licensor and, uh, or the licensee. And so, um, Well, that applies to the milestones and the royalties.
spk05: Yeah, so taking a step back in terms of just in general, right, at DARE, because I think it's an important thing to understand, our portfolio is built, right, of products in women's health that we selected based on the products Indication we wanted to treat, right, that we identified is having that, you know, kind of going back to the beginning of the call, the three things I talked about that are so important to us in terms of making sure we're bringing ultimately to market very differentiated products that have considerable market opportunities. So you start with the need. you identify that, you design that sort of target product profile, and you go look for the product. And what that means, therefore, by design is that in our portfolio, someone else has likely invented it, right? And so there are financial obligations that we owe to a third party. But we built our company knowing that was our strategy and that we would not, as a company, you know, find ourselves in a place where we have to bear the expense of commercialization, right? You heard Lisa talk about our burn. Our burn is so low despite the fact that we have 12 products in active development and it stays low relatively, right? Because we have been able to enter into commercialization partnerships. So knowing that we are going to do that upfront, All of our transactions, all of our in-license transactions are designed to support exactly what you talked about, that we're going to get money from someone, and we are likely going to owe money to right, to someone else, but ultimately that has to make sense for our shareholders, right, because ultimately that's who we are working for, right? And so we look at all of that. Our deals are all very different. Every transaction is different depending on the indication, the opportunity, the likely downstream transaction that we're going to have, and the nature of the product. So in this case, but generally, to your point, they do include some milestones and royalties to the other party. You know, in this transaction, we have 180 million, as Lisa talked about, in terms of milestones that we're eligible to receive from Organon on top of the double digit. tiered royalties. In this case, our license or the milestones are quite low. And I can let Lisa talk to them specifically because we've just disclosed them. So they're nowhere near the 180.
spk01: Yeah, no. And thank you, Sabrina. And exactly what she was describing. Each deal is different, but with our license, so this is to obtain the rights to the product, our license agreement with Milano Farm, we will only owe them one commercial milestone, and we've disclosed that that's $1 million when the net sales are over $50 million, and then just to bring it, and so that's it on commercial milestones, and everything else is a low royalty based on net sales.
spk05: Yeah, and then there is the $500,000 on the first commercial sale, right? Yeah.
spk07: Okay, so there's a way to think about... Go ahead. The way to think about how the royalty works is in a way you're keeping, for lack of a better term, a spread between what you're getting or will get from working on versus what you'll pay out.
spk05: Yeah, absolutely. Obviously, there's a spread on just the royalty part, and then there's a spread, as we were just talking about, specifically on the milestones, which are two different, right? Those are two different revenue streams coming into DARE.
spk07: Great. Thank you.
spk04: Absolutely. Yeah, thanks.
spk09: Your last question comes from Doug Tissell with HC Wainwright.
spk08: Hi, good afternoon. Thanks for taking the questions. Just curiosity, with Zasciato, do you know, will this be available at the pharmacy or will this be distributed through a specialty pharmacy?
spk05: Yeah, at the pharmacy. And I don't know, John, if you want to say any other comments on this.
spk02: Yeah, just like every kind of broad women's health product, it's going to be available through the pharmacy. So the retail outlet is where you'll see the product show up.
spk04: Yeah. And, you know, and, oh, go ahead, Doug.
spk08: No, I was going to ask this as a follow-up. Do we have a sense of the tax transfer and the timing for Organon taking on the manufacturing?
spk05: Yeah, great question. So, as, and just for the benefit of others, so our agreement with Organon does have us today. Daria is still overseeing the manufacturing activity and is the holder of the marketing authorization contract. But it does contemplate that at some time, Organon will take over those manufacturing responsibilities. And we've obviously together have been working on that. These things take time. You know, so Zasciato, it's part of what we love about Zasciato because it's part of, in addition to intellectual property, part of what protects the brand. You know, it's a very specific brand. technology in order to to make that hydrogel technology it does require I see certain equipment and certain processes and all of that good stuff so we have obviously started the tech transfer process but just mechanistically there's time in terms of things that are needed right equipment that is needed that is specialized in order to to make Zasciato a And then there's also kind of, you know, just the regulatory piece of, right, the process of switching manufacturers. So both parties are, you know, working hard at this, but this is not a, you know, just to set everyone's expectations, you know, appropriately, a tech transfer for something like this in this manner, right, where it's not just a CDMO, where it's truly going to transfer hands from a regulatory perspective as well. is a process that takes time. This is not a tomorrow thing. You know, this is something that takes time and effort from both parties, and we are working diligently together on it.
spk08: Okay, great. Thank you so much.
spk04: Yeah, absolutely.
spk09: There are no further questions at this time.
spk05: Great. Well, thanks, first of all, for the great questions. We really appreciated the opportunity to share our thoughts on some of the upcoming milestones this quarter and spending some time on that and this year. And thanks, everyone, for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of DARA's stakeholders. We've talked about the shareholders today, but obviously the women and the health care providers. And with our diverse portfolio, we really seek to bring to market differentiated prescription therapies that prioritize women's health and well-being, that expand the treatment options where none exist, enhance outcomes where current standard of care has meaningful shortcomings, and improve ease of use for women where a more compelling form factor can drive adoption, primarily in the areas we've been talking about and some that we haven't touched on today, like contraception, vaginal health, reproductive health, menopause, sexual health, and fertility. So we very much look forward to keeping you updated on our progress and the milestones anticipated this year that I outlined earlier, which include the Zasciato product launch and first commercial sale and milestones associated also with our three candidates entering phase three clinical development. And so to list all the milestones again for 2023 that we've talked about, we have the Phase 2B response. Top line study results for this is NFL CREAM study for female sexual arousal disorders. So this quarter is what we're targeting on that. Similarly, this quarter, the U.S. first commercial sale of Zosciato by Organon. In addition, as we've talked about, the initiation of that Phase 3 clinical study of oviprene, which is our Investigational potential first and category hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer. And again, as we've talked about, we expect that to be a single pivotal study to support oviprene's pre-market application. We didn't, other than to mention them, talk about these in detail today, but as we mentioned, the IND-related activities for DER-HRT1, which is our investigational 28-day intravaginal ring for hormone therapy. for the vasomotor symptoms in menopause and DERVVA1, our investigational hormone-free intravaginal minister treatment for vulva and vaginal atrophy. So phase three and phase two activities respectively for those and clinical study initiation plans for those candidates. And then mentioned PDM1, which is our investigational vaginal hydrogel formulation of diclofenac for menstrual cramps. Very much looking forward to that phase one study completion. which is underway right now, and then the top line data this year. So that's all just for 2023. So thank you again for your time today, and we look forward to keeping you updated.
spk09: This concludes today's conference call. You may now disconnect.
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