Daré Bioscience Inc. Q1 2023 Earnings Call
Speaker 1: I that.
Speaker 1: you
Speaker 2: Welcome to the conference call hosted by Daraa Bioscience to review the company's financial results for the quarter ended March 31, 2023. And to provide a general business update. This call is being recorded.
Speaker 2: 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. And I'm going to hand it over to you. Great.
Speaker 3: So good afternoon and welcome to the financial results and business update call for the quarter ended March 31st 2023 for Daria Bioscience.
Speaker 3: 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 Prime Minister.
Speaker 3: 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, 2023.
Speaker 3: Dyer undertakes new obligation, depicting a forelooking statement to reflect new information or developments after this call except it is required by law.
Speaker 3: or nearing phase three clinical development, is focused solely and squarely on women's health and is built upon the following core principles.
Speaker 3: Each product candidate must address a meaningful market opportunity in the form of a persistent and unmet need.
Speaker 3: 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 standards of care.
Speaker 3: And ideally, each product candidate has demonstrated proof of concept and or uses while characterized active pharmaceutical ingredients, which can mitigate development time, cost, and even risk. Our current innovation efforts are focused in contraception.
Speaker 3: Vaginal health, reproductive health, menopause, sexual health and fertility.
Speaker 3: On our recent 2022 financial results and update call, we discussed the key milestones anticipated for the year 2023.
Speaker 3: to Denifil cream for female sexual arousal disorder.
Speaker 3: The U.S. Launches a Shiat O, by organon.
Speaker 3: The initiation of the Phase III clinical study of overpring are investigational, potential first in category, hormone-free, monthly, intravaginal contraceptive, whose US commercial rights are under a license agreement with Bayer, which we expect will be the single pivotal study to support overpring pre-market application.
Speaker 3: IND related activities for DRHRT1, which is our Investigational 28-Day Interventional Ring for Hormone Therapy for the Vezamotor Symptoms of Menopause. And IND related activities for DRVVA1, our Investigational Hormone Free Intervalgely and Minister Treatment for Bulbulin Vaginal Atrophy.
Speaker 3: As well as our Phase 3 related clinical study plans for the Canada's DERHRQ1 and Phase 2 clinical study plans for DERGD-81.
Speaker 3: Additionally, their PDM1, which is our Investigational Vaginal Hydrogel Formulation of the Closenac, to treat primary dysminorrhea or menstrual cramps, the Phase I study contact and the top line data this year.
Speaker 3: On today's call, Lisa will review our first quarter, 2023 financial result shortly. But we will otherwise focus on our anticipated milestones for this quarter, this second quarter of 2023. So namely, we'll send our time today on the Sedentisl Cream 3.6% phase to be respond study for writing a Greek
Speaker 3: and the commercial launch of Dashiado in the US by Oregonon. We'll start with the CINICAL cream update and we will review both the exploratory phase to be a response study objective to provide context for the anticipated upcoming top line data readout. And as importantly, we'll talk about the market dynamics for female sexual aroused with disorder.
Speaker 3: a fill cream, 3.6%. We're looking to address the lack of physical, general, arousal response and sensations and the associated distress, but are the hallmark of female sexual arousal disorder or FSAD.
Speaker 3: As I mentioned up front, FSD is a malignant to erectile dysfunction or ED in men.
Speaker 3: 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.
Speaker 3: As we approach the Phase GB top line data readout expected this quarter, we wanted to give you a sense of what you can expect.
Speaker 3: First, by way of refresher, previously conducted studies by Dauré and our licensore SST demonstrated that this cream formulation of sedentifil, which is the same active ingredient as in Viagra, increased blood flow to the female genital tissue.
Speaker 3: Both when assessed via an internal vaginal probe and when assessed via an external temperature sensing camera.
Speaker 3: These data provide the proof of concept that the formulation is achieving its target activity in the tissue, increasing blood flow.
Speaker 3: Obviously, vaginal probes and general temperature sensors are not practical end points for a Phase III program.
Speaker 3: Thus, the exploratory Phase IIb study was designed to evaluate the performance of the sidentifo 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 IIb study.
Speaker 3: be as large or larger in terms of potential patients as the ED market.
Speaker 3: 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 general arousal symptoms associated with FSAD. 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 general arousal symptoms associated with FSAD.
Speaker 3: As I mentioned, Susenifil is the active ingredient in Diagra, and our innovative topical cream formulation for women is designed to be used on demand. Prior to sexual activity, and to deliver Susenifil directly to the general tissue to facilitate vasodilation, an increased blood flow directly where needed.
Speaker 3: to improve the physical arousal response to address the lack of those general arousal sensations, commonly associated with FSA-D. The Sedentifil Cream has the potential to be the first FDA approved product to treat FSA-D and create an entirely new market of comparable addressable market size as ED.
Speaker 3: 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 in prescription, filled for Viagra in its first full quarter on the market.
Speaker 3: of uptake that I described in the Viagra launch from both providers and patients is incredibly impressive.
Speaker 3: And we see a number of similarities between ED and FSAD markets. To principally an 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.
Speaker 3: As is now the case with women with FSAG. Without a viable intervention for ED like Viagra, men were reluctant to have a conversation or ask their provider for help or information.
Speaker 3: According to a 2004 study conducted by the British Medical Journal, the authors noted that men reported that ED affected their personal relationships, often less than feeling embarrassed, and they generally suffered in silence, as many men felt unable to talk to their partners or friends about their condition.
Speaker 3: The authors also noted that once Niagara became available and when it provided symptom relief, men reported feeling happy and elated as well as great improvements in their well-being.
Speaker 3: 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.
Speaker 3: 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 FFAD in terms of the path of physiology of the condition, as well as the psychological and emotional impact that we've been discussing,
Speaker 3: We believe there is enormous unmet need, and we see the potential for a large amount of pen-up demand for a product like Sudena Philcreme.
Speaker 3: Therefore, we are excited to bring our exploratory face to be steady 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.
Speaker 3: 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 end points to evaluate in the Phase 3 program.
Speaker 3: In addition to the Phase-2B study where the product was used at home, we recently announced the initiation of a supplemental tomography study in a clinical study, in a tonical setting. This Phase-1 tomography study of Sudennephal Cream is expected to enroll around 15 women and to be completed this year.
Speaker 3: These data are an important part of our comprehensive clinical development and regulatory plan for sudden adult green 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-to-be-response trial in preparation for a phase-3 program.
Speaker 3: Our goal is to bring a much needed solution to the women estimated to be 10 million in the United States alone who are just stressed and seek treatment for low or no sexual arousal. And with no FDA approved option to address their condition, our goal is for Sudena Philkreme to be the first FDA approved product for women women.
Speaker 3: on the OvaPren 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 is a single pivotal contraceptive clinical study required to support the PMA submission for registration.
Speaker 3: I also want to mention that we are thrilled with the interest in our dairy PDM1 study that is underway in Australia. I'm at the reminder this is our investigational product to treat primary dysminarie or menstrual cramps by delivering the non-starortal anti-inflammatory drug diklofenac vaginally using our proprietary hydrogel formulation that same
Speaker 3: 28 billion by 2029.
Speaker 4: So with those updates on the development programs, I will now turn it over to John to provide a commercial update on the Zasciato Launch activities. Thank you, Sabrina. As a reminder, Zasciato, Clinton, Mayas, and Fossate Vaginal Gel is when Kosomy antibacterial for single dose vaginal administration indicated for the treatment of bacterial vaginosis. Thank you.
Speaker 4: in female patients 12 years of age and older in the United States.
Speaker 4: The Zashia Dostory is great validation of our portfolio candidate selection and development strategy. Vacterial vaginosis is the most common vaginal condition in women of reproductive age, estimated to affect approximately 23 million women in the U.S. 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.
Speaker 4: 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.
Speaker 4: completed, commercial launch activities are progressing. Given that the sales team for Nexplanon will be launching Zaxiado, we expect that Zaxiado 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...
Speaker 4: for their patients.
Speaker 4: As I mentioned on our last update call, Organon has, will we believe to be a truly integrated go-to-market plan targeting all 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.
Speaker 4: Organon has been working on launch activities. They're taking a holistic approach to the products introduction, including ongoing work in the areas of non-sales force related promotional activities, and utilization of key symposia and conference events.
Speaker 4: Oregon on 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 pharmac economic insights and learnings across a broad range of products
Speaker 4: 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 Marquis Conference in Women's Health, the American College of Obstetricians and Gynecologists.
Speaker 4: 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 CHCP's focused in women's health, which is critical given the role that OB-GYN offices play in treating patients with bacterial vaginosis.
Speaker 4: And finally, I know we touched on this earlier, but I feel it's worth repeating, organon will leverage its established next one on sale 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.
Speaker 4: The next one on Salesforce 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 organized next one on sales team, coupled with Organons Payer Outreach, Provider and Patient-Centered Initiatives.
Speaker 4: 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.
Speaker 2: Thank you, John , and thanks everyone for joining us today. I would now like to summarize Daria's financial results for the quarter ended March 31, 2023, which I will refer to as the current quarter or first quarter.
Speaker 2: and primarily reflected the costs of two of our later stage programs, including the ongoing cell-denifil screened 3.6 percent phase to be respond clinical trial, and manufacturing and regulatory affairs activities related to overpring. Our comprehensive loss for the quarter was approximately $8 million. We ended the first quarter with approximately $19.8 million in cash and cash and equivalent, and we had approximately $86.3 million shares of common stockout standing as of May 10th.
Speaker 2: In terms of upcoming milestones in future sources of cash under our license agreement with Oregonon to commercialize the Seattle, we are entitled to receive $2.5 million following first commercial sale. Their after will be eligible to receive potential additional milestone payments of up to $180 million.
Speaker 2: as well as tiered double digit rail tees based on Sashiyato's net sales.
Speaker 2: 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.
Speaker 2: As a reminder, these alternatives include, but are not limited to, non-dilutive grants, fee sales, license agreement, structured financings, and other financial services.
Speaker 2: 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 the financial resources. We also encourage investors to review the more detailed discussion of our financials, our financials, and the financial resources.
Speaker 2: I would now like to turn the call back over to Mallory, the operator.
Speaker 3: 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.
Speaker 2: Your first question comes from the line of Catherine Novak with Jones Research.
Speaker 5: 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 and patient?
Speaker 3: is get everyone ready 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, kind of as the name implies, they're questions about what someone might be feeling, literally a sensation.
Speaker 3: 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. Do we use some of the...
Speaker 3: 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 do they, what are they not feeling physically, what are the words they use to describe it, and what would they like to see improved.
Speaker 3: And so those are the types of things that we included in our study. And to your question too about the difference between those kind of questions.
Speaker 3: versus desire disorder, you know, think about what Sudanese does. Sudanese increases blood flow, right? That is what it does, right? Through its mechanism. And so we're really focusing on questions about what Sudanese does and what someone is likely going to feel as a result of that.
Speaker 3: And that's very different from desire. Desire is, it's interest, right? It's emotional. It's are you interested in having a sexual activity? Do you have sexual fantasies, right? It's more that thought aspect of it.
Speaker 3: 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, both before we enroll them in the study, and to understand all the benefits, right, that a product like Sudenapeh could potentially have. But the focus is really on those general sensations.
Speaker 3: right, those physical manifestations as opposed to, you know, how interested they are or how much they fantasize.
Speaker 5: Right, that's helpful. My understanding is the FDA does not have separate draft guidances for arousal and desire disorders.
Speaker 3: They're kind of locked together. Correct. Yeah, so what they did, it's one guidance document, but it is very, very clear that the conditions are different. So what they've done is they have one guidance document that covers both as discrete conditions, sexual-lateral disorder and hypoactive desire disorder.
Speaker 3: but they all are 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, you know, in terms of approaching the FDA and talking about, you know, studies and talking about indications that really led to ultimately the FDA putting out that draft guidance document.
Speaker 3: 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.
Speaker 3: for those exploratory endpoints so that we really have an opportunity to take the best most responsive questions forward into the Phase 3.
Speaker 3: Got it. No, that's helpful. Thanks again, and congrats on the quarter. 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.
Speaker 3: So the primary endpoint really came out of an already validated questionnaire, a sexual function questionnaire of 28 questions, and then we used this particular arousal domain of it, and then an already established and validated questionnaire around 28 questions.
Speaker 3: 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.
Speaker 3: 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 atraditional, right? A traditional top-line data readout usually just has the primary endpoint. But, you know, 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...
Speaker 6: Your next question comes from Kumar Raja with Ross Capital.
Speaker 7: Thank you for taking my questions and congratulations on the progress. Continuing with the seal-dapal cream.
Speaker 7: What is the expectation in terms of when you will have the full data set?
Speaker 3: 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..
Speaker 3: and really have an opportunity to go through all of it very carefully and ultimately compile your clinical study report. That, as you probably well know from other corporate experiences, you know, can take weeks to months, right, 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, you know, a smaller company. You can work quickly, but there...
Speaker 3: 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 3 and what's going to happen.
Speaker 3: 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.
Speaker 3: you know, the data are as we hope we want to move this forward as fast as we possibly can, but we also know we only get, you 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.
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? 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, you know, 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 demography 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 IIB study, and that's what determined our dosing regimen. And in the Phase IIB, 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, you know, 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.
looking at what is the placebo curve and vehicle curve and active curve, what is the no product, 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 Full Program, we're really making sure we're taking a lot of of time and making sure that we're doing what we need to be. Okay.
specific data into consideration. Okay, that's great. And maybe finally in terms of overprene, maybe just provide some highlights like is everything going as expected for the mid-23 trial start? Yes, no, we're super excited. So the NACHD has been fantastic to work with. They started doing work and prepping the core sites that we're going to have in the study, which are part of their contraceptive...
nicely. As you know, part of the time we have said was also regulatory time. Remember that the ID approval from the FDA came with some comments and things that wanted to comment some 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 this.
as planned right now.
Thank you so much. Yep. Your next question comes from the line of camp dolever with Brookline Capital. Good afternoon. I'm going to ask about Zasciano and. And.
the context of the question. I did it at the eyeshadow too. Yes. So excuse me, 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, it does appear to be getting some formulary coverage.
And I think they were a heart of my question is, given all this talk about launch and the fact that you haven't saved.
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 is actually detailing it. Have they started detailing the product?
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
And as John also noted, there were, and we've mentioned on past calls, there were manufacturing validation activities that had to happen before you could put product in the channel, right? So, 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 activity.
big branded, right, branded exhibit event 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 second quarter.
Okay, super. And the product is light in life and I think you have to share the economics with the life and so on or life and see. And so that applies to the milestones and the royalties. Yeah, so taking a step back in terms of this.
in general, right, at Dara, because I think it's important to be able to understand. Our portfolio is built of products and women's health that we selected based on the indication we wanted to treat, right, that we identified as 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.
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've heard me to 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-licensed transactions are designed to support exactly what you talked about that you know we're gonna get money from someone and we are like we're gonna owe money, right to someone else but ultimately that has to make sense for our share.
The milestones are quite low and I can at least talk to them specifically because we've just disclosed them so there's no way or near Pudernade. 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 just close that that's one million dollars when the net sales are over
how the royalty works is in a way you're keeping, for the lack of a better term, a spread between what you're getting or will get from Morganon versus what you'll pay out. 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 revenues.
available at pharmacy or will this be distributed through a best-of-farmacy? Specialty Pharmacy. Yeah, at the pharmacy, and I know John , if you want to see any comments on this, just like every, you know, kind of broad women's health product is going to be available through the pharmacy. So the retail outlet is where you'll see the product show up. And, you know, and go ahead, Doug.
I was going to ask you to follow up. Do we have a sense of the tech transfer and the timing for organon taking on the manufacturing? Yeah, great question. So, 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 then is the holder of the marketing authorization. So, as we know this is negative, that we are saving energy and saving for the organ, we work for hours and hours, it reflects bringing life to another.
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. So, Dashiado is part of what we love about Dashiado because it's part of an addition to intellectual property, part of what protects the brand. You know, it's a very specific technology in order to make that hydrogell technology. It does require, I see certain equipment and certain processes and all of that good stuff. So, we...
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...
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 end 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 Dari'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 a...
earlier, which include the Zaxiada product launch and first commercial sale and milestones associated also with our three candidates interning phase three clinical development.
first commercial sale of Zaxiado by Organon. In addition, as we've talked about, the initiation of that Phase III clinical study of oviprene, which is our investigational potential first and category hormone-free monthly intervaginal contraceptive, whose U.S. commercial rights render a license agreement with Bayer. And again, as we've talked about, we expect that to be a single pivotal study.
one are investigational hormone-free intervaginal administered treatment for vulvar 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 steady 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.
This concludes today's conference. All you may now disconnect.
I have.
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