Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2022 Earnings Call Transcript

Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2022 Earnings Call Transcript March 30, 2023

Operator: Welcome to the conference call hosted by Daré Bioscience to review the company’s Financial Results for the Year Ended December 31, 2022 and to provide a general business update. This call is being recorded. My name is Abby and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Commercial Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer. Ms. Johnson, please proceed.

Sabrina Johnson: Thank you. Good afternoon and welcome to our year-end December 31, 2022 financial results and business update call for Daré Bioscience. Our plan today is to review our full year results, discuss development since our last call in November and use the time to review our business strategy, including why we believe investment in women’s health is efficient and disproportionately impactful and to 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 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 these 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 annual report on Form 10-K for the year ended December 31, 2022 which was filed today. I’d also like to point out that the content of this call includes time-sensitive information that is current only as of today, March 30, 2023. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

By the time 2022 came to a close, we had secured our second commercial collaboration in this case, for our FDA-approved product, XACIATO with Organon. We received FDA acceptance to commence what we believe will be the single pivotal study required for our monthly hormone-free contraceptive candidate, Ovaprene, commercial rights to which our under license agreement with Bayer. We announced that we completed enrollment in our Sildenafil Cream female sexual arousal disorder Phase IIb study and we announced 2 positive Phase I/II study top line readouts, one for our hormone-free vaginal atrophy treatment candidate, DARE-VVA1; and one for our 28-day vaginal ring hormone therapy candidate for the vasomotor symptoms in menopause, DARE-HRT1. These accomplishments in 2022 position us well to potentially achieve additional commercialization, clinical and regulatory milestones in 2023, that I look forward to sharing shortly.

And our 2023 milestones include not only objectives related to the programs I just identified but to other portfolio candidates as well. Those who have been following Daré know that we are focused solely and squarely on women’s health. With 12 independent stand-alone development stage candidates in our portfolio, we have, to our knowledge, the deepest pipeline of women’s health product candidates of any other company, including global pharmaceutical companies. It has been reported that a mere 1% of health care research is invested in female-specific conditions beyond oncology. And yet, based on IQVIA data for 2013 to 2022, women’s health products make up 27% of the blockbuster products as in those that generate over $500 million in annual sales.

And those products contribute 35% as a revenue generated by all blockbuster products. Thus, given those statistics, with 12 development stage candidates in our portfolio, we like our odds of generating value for our shareholders and the disproportionately impactful investment, a women’s health product candidate can potentially represent particularly given that a number of our candidates are in the contraceptive, menopause and sexual health categories, all of which have seen over $1 billion and even over $2 billion individual brand, including the potential of our sexual health program, Sildenafil Cream, since there is yet to be an FDA-approved product for arousal disorder in women, the most analogous condition in women to erectile dysfunction in men.

We would love the first and more on our cinemas program shortly. So as such, it is our belief that prioritizing women’s health is not only good for the many women lacking effective or convenient therapeutic options. And for the broad set of stakeholders, they care about women’s health, including family members and partners but importantly, also for those investing in the category. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health and fertility. We chose these areas because we saw opportunities to bring new innovation to women in indications where we could be first to market, have a first-in-category product or develop the first-line product in a given therapeutic category.

So while we have a broad portfolio, importantly, every single product candidate in our portfolio has to stand on its own merits to justify our investment in that individual product candidate. Specifically, before we select a new candidate for development, we make a determination that it meets the strict criteria. First, the product candidate has to address a meaningful market opportunity in the form of a persistent unmet need. Second, it has to have the potential to be first line or first in category or both. Third, it should already have demonstrated proof of concept and ideally use well-characterized active pharmaceutical ingredients which committed gate development time, cost and even risk. And finally, it should represent an opportunity to deliver a clear improvement over the standard of care as measured by clinical outcomes and patient acceptability and is ultimately evidenced by a clearly differentiated product label which is critical for market access and pull-through.

Our focused efforts to deliver differentiated innovation in women’s health have resulted in 12 development-stage programs across 9 distinct indications. With more than 5 milestone events anticipated in 2023 that we will discuss shortly, 3 candidates in or nearing Phase III development, 2 potentially transformative transformational collaborations with leaders in women’s health product commercialization, Bayer and Organon and 1 FDA-approved product XACIATO. I want to share with you now Daré’s key 2022 results and milestones and our anticipated 2023 milestones. In addition to my remarks, I encourage you to read our press release issued this morning since it provides a more comprehensive review of our 2022 accomplishments. We have important upcoming milestones for XACIATO, Ovaprene, Sildenafil Cream, DARE-VVA1, DARE-HRT1 and DARE-DPM1.

So I’m going to focus my comments today primarily on those programs. So let me begin by highlighting our global license agreement with Organon that supports the commercialization of XACIATO, clindamycin phosphate vaginal gel 2%. As a reminder, XACIATO is a lencostamide 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 XACIATO story is a great validation of our portfolio candidate selection and development strategy. Bacterial vaginosis is most common vaginal condition in women of reproductive age, estimated to affect approximately 23 million women in the U.S. alone. But yet a number of women with the condition have been underserved by currently available products.

We hoped that by focusing on improving outcomes and her overall user experience, we could deliver a novel option. Understanding the differentiation drives value, we stroke to design a Phase III study to generate the data necessary to support the target labeling. And by doing so, create the opportunity for a commercialization collaboration that could drive value. We are thrilled that Organon, the women’s health focused spin out of Merck is launching XACIATO and that they will leverage their established Nexpenon sales team to accelerate XACIATO uptake. Specifically, with the manufacturing validation activities required to support the commercial launch now nearly completed, we are excited about the commercial launch activities underway at Organon, in preparation for what will be Organon’s first pharmaceutical product launch into the women’s health category since spinning out of Merck.

Given that the Nexplanon sales team will be leveraged for the XACIATO to launch, we expect to benefit from the track record of commercial success that team has demonstrated. Organon believes that there is roughly a 90% overlap of those health care providers who prescribe Nexplanon and our viable XACIATO targets based on treatment patterns. The strong relationships the sales team has with these providers are expected to enable immediate access. We anticipate the first commercial sale before the end of the second quarter, more on the XACIATO commercial activity when John provides his update. In terms of our Ovaprene program, the FDA’s acceptance of our Ovaprene IDE last year was an important milestone for the program, as it allows us to commence what we believe will be the single pivotal clinical study required to support the PMA submission for registration.

Ovaprene is our investigational potential first-in-category hormone-free, monthly intravaginal contraceptive, whose commercial rights around a license agreement with Bayer. We announced IDE approval for our planned pivotal study by the FDA in October 2022 and confirmed our belief that a single pivotal study of approximately 12 months duration will be sufficient to support a PMA submission to the FDA. The study will target having around 200 to 250 subjects complete, 13 mental cycles of use. The pivotal study is being conducted under a collaborative research and development agreement, or CRADA, with the NIH’s NICHD division and with NICHD’s contraceptive clinical trial network. And in December, NICHD brought the investigators from those sites together for an investigator meeting.

We anticipate initiation of pivotal Phase III subject recruitment in the middle of 2023. So that’s 2 innovative brands, XACIATO and Ovaprene and 2 potentially transformational collaborations, one with Organon and one with Bayer. So what’s next for Daré on our unpartnered programs. Well, let’s begin listen premium 3.6% to a product candidate with the potential to create a completely novel category in women’s health. We are looking to address the lack of physical general arousal response and sensations and the associated distress that are the hallmark of female sexual arousal disorder, or FSAD. As I mentioned upfront, FSAD is analogous to erectile dysfunction or ED in men, both in terms of pathophysiology as well as target pharmacology and the addressable markets are also quite comparable in size.

We completed enrollment in our exploratory Phase IIb study in 2022. And as we approach the Phase IIb top line data readout projected for the second quarter of 2023, we wanted to give you a sense of what you can expect. First, by way of refresher, previously conducted studies by Daré and our licensor, SST, demonstrated that this cream formulation of Sildenafil which is the same active ingredient as in Viagra, increased blood flow to the female genital tissue, both when assessed to be 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. Obviously, vaginal probes and genital temperature sensors are not practical endpoints for a Phase III program.

Thus, the exploratory Phase IIb study was designed to evaluate the performance of Sildenafil Cream and to evaluate a number of different potential ways to ask women questions about their general sensations and improvements referred to as patient reported outcomes in the at-home setting, in order to identify and select the appropriate patient-reported outcomes to take forward into Phase III program. Therefore, as we bring our exploratory Phase IIb study to a conclusion, we will, as a first step, report top line data for a number of the assessment tools we utilized in the study and 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.

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 no FDA-approved product option to address their condition today. Third, I’d like to highlight the positive top line results from the 2 Phase I/II studies completed last year, one for DARE-HRT1 and another for DARE-VVA1, both of which were conducted through our wholly owned Australian subsidiary. So let’s start first with the Phase I/II study of DARE-HRT1, a menopausal hormone therapy for the treatment of the vasomotor symptoms of menopause, or VMS. Fortunately, many of you probably watched the Super Bowl and saw Astellas’s ad challenging people to answer the question, what is VMS.

But it may be worth reminding you that VMS stands for vasomotor symptoms in menopause which are commonly referred to as hot flashes. With over 45 million in women in the U.S. estimated to be in or approaching menopause each year and with the legacy brand in the category, having generated $2 billion in annual revenue, it’s not surprising that the condition was a subject of a Super Bowl ad. So what are we developing for the condition? Well, DARE=HRT1 has the potential to be a first-in-category convenient combination hormone delivering monthly vaginal product for the treatment of the vasomotor symptoms in menopause. Specifically, DARHRT1 is an investigational intervaginal ring designed to release bioidentical estradiol and bioidentical progesterone through this vaginal ring over 28 days.

So DARE-HRT1 has the potential to be the first nondaily, nonoral monthly format product with both bioidentical hormones. There are no FDA-approved options with both hormones and 1 monthly IBR. Hormone therapy remains the most effective treatment for the vasomotor symptoms of menopause and the genitourinary syndrome of menopause and has also been shown to prevent bone loss and fracture. The 2022 hormone therapy position statement of the North American Menopause Society, or NAMS, supports hormone therapy in peri and postmenopausal women and NAMS observes that nonoral routes may offer advantages over oral routes administration. We previously announced the top line data from that Phase I/II study of 2 different dose combinations of DARE-HRT1 over 12 weeks of use in approximately 20 healthy postmenopausal women.

And as we reported, the levels of estradiol released from both the lower and the higher dose formulation of DARE-HRT1 achieved or exceeded the levels that were targeted for hormone therapy. In addition, despite the small sample size, the levels of estradiol released from both the lower and higher dose formulation evaluated in the study achieved statistically significant improvement compared to baseline in BMS as well as the genitourinary symptoms of menopause and vaginal PH and maturation index, all at the P less than 0.1 level. These data support the potential of DARE-HRT1 to deliver effective hormone therapy in a convenient 28-day vaginal ring. Following clinical development, we intend to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and pedestrone specifically to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DAIR-A2T1 in the U.S., that pathway that 505(b)(2), that’s the same pathway we use for XACIATO.

We intend to seek FDA approval of DARE-HRT1 for the treatment of moderate-to-severe vasomotor symptoms due to menopause in women with intact uterine. Based on pre-IND communications with the FDA and the top line pharmacokinetic or PK data from the DARE-HRT1 Phase I/II study, we believe FDA approval of DAER-HRT1 for that indication is achievable via that 505(b) pathway supported by a single placebo-controlled Phase III clinical trial of DARE-HRT1 and a scientifically justified PK bridge basically via relative bioavailability trial between DARE-HRT1 and the selected listed estradiol and progesterone drugs. Ongoing activities to support the pressing directly into that single Phase III study to support registration, include manufacturing and nonclinical studies to support the IND submission and the planned therefore IND opening Phase III study.

We look forward to providing further updates on the time lines to Phase III as these activities continue to progress this year. The second Phase I/II study conducted in Australia was for DARE-VVA1, our hormone-free vaginal atrophy treatment candidate. There are currently no FDA-approved products labeled as safe for use in hormone receptor positive breast cancer. DARE-VVA1 has the potential to be the first in category hormone-free vaginal treatment for vulvar and vaginal atrophy, or VVA. DARE-VVA1 is an investigational proprietary formulation of tamoxifen for intravaginal administration. Approximately 4 million women in the U.S. have a history of invasive breast cancer. It’s estimated that more than 66% are hormone receptor positive cases. VVA which can lead to painful intercourse and associated interpersonal distress is prevalent in postmenopausal breast cancer survivors with rates estimated at 42% to 70%.

These women are generally not candidates for hormone-containing therapies despite their vaginal atrophy symptoms, as the use of estrogen in any form is often contraindicated for hormone receptor positive breast cancer patients and survivor. So there is a clear unmet medical need for an effective nonhormonal treatment for VVA. And in November of 2022, we announced the positive top line results from our Phase I/II study of DARE-VVA1. In that study, DARE-VVA1 demonstrated improvement in vaginal cytology parameters and bothersome symptoms of VVA supporting the ongoing development. Following clinical development, we intend to similarly leverage the existing safety and efficacy data on the active ingredient in DARE-VVA1 tamoxifen and again, to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-VVA1 in the U.S. As we continue to engage with the FDA on the IND process this year, we’ll provide additional updates on the time line to Phase II.

Last development candidate I’d like to highlight is DARE-PDM1, our investigational product to treat primary dysmenorrhea, or menstrual cramps by delivering the NSAD diclofenac vaginally, utilizing our proprietary hydrogel formulation, the same formulation technology that is used in XACIATO. We initiated a Phase I study of DARE-PDM1 this year in Australia and top line data are also expected this year. Primary dysmenorrhea is defined as painful menstruation in women with normal pelvic anatomy typically described as cramping pain in the lower abdomen before, during the menstrual period. Recent market research suggested the global market for dysmenorrhea treatment is estimated to be valued at $13 billion in 2022 and that the size of this market is expected to increase to $28 billion in 2029.

Primary dysmenorrhea usually begins during adolescence and is a leading cause of recurrent short-term school absence and adolescent girls and a common reproductive age. According to the American College of Obstetrics and Gynecologists Committee on adolescent Healthcare, it’s the most common menstrual symptom of adolescent girls and young women and most adolescents experiencing it have primary dysmenorrhea. The preference rates range vary but they range from 15% to 19% . The most common interventions for temporary relief for the painful symptoms, include oral NSAIDs or hormonal contraceptives which often can produce undesirable side effects, oral NSAIDs which are available over the counter may cause an increased risk of gastrointestinal adverse events, including nausea, vomiting, bloating alterations and hormonal contraceptives can also produce a number of undesirable side effects.

So by leveraging a vaginal administration, we believe we can provide a localized treatment option that addresses the pain-related symptoms at the condition while minimizing side effects commonly seen with the oral medications. Because there are currently no FDA-approved vaginal diclofenac treatment options for primary dysmenorrhea, DARE-PDM1 has the potential to be a first-in-category product, delivering diclofenac in a convenient vaginal format that may extend the duration of pain relief and reduce side effects commonly associated with the oral delivery of NSAIDs. Now in my opening comments, I noted that part of our strategy is to identify promising candidates that can be developed efficiently in terms of time and cost. The ability to leverage our hydrogel platform technology that has recently undergone successful preclinical and clinical testing and regulatory review could offer both time and cost savings and advantages in the development of new candidates to address meaningful unmet needs in women’s health.

It is our hope that the development of DARE-PDM1 and DARE-LDT1 which I’ve not discussed today but similarly relies on the hydrogel platform, will benefit from the use of that technology that has already been closely evaluated. I will now turn it over to John to provide an overview of the 2 license agreements we have in place for commercialization of XACIATO and Ovaprene, respectively.

John Fair: Thank you, Sabrina. As Sabrina outlined, we strive to develop differentiated first-line or first-in-category products. We believe this creates optionality for our commercialization strategy by allowing us to enter into commercialization agreements as we have with XACIATO and Ovaprene on a product-by-product basis and in those circumstances where we believe a collaborator with an established commercial capability in women’s health is the most effective and efficient way to bring a Daré product to market and the optimum way to provide value to Daré stakeholders. Our model gives us the flexibility to work with top commercial companies in women’s health for certain products but also directly engage in commercial activities for other Daré products when we believe it’s most appropriate strategy given the target product profile and the stage of development within our portfolio.

As Sabrina outlined, we retain this level of optionality with the remaining 11 development stage product candidates in our portfolio. To date, we have entered into commercialization license agreements with what we believe to be our 2 of the best commercial companies in women’s health. The value of having the breadth and experience of a women’s health commercial market leader behind the brand is clear when we consider the XACIATO go-to-market strategy. We continue to remain excited about XACIATO’s launch as we look forward to seeing XACIATO added to the health care providers armamentaria. As Sabrina noted, Organon has been working on launch activities, taking a holistic approach to the products introduction which will include direct selling which is also known as personal promotion as well as nonpersonal promotion efforts and utilizing key digital platforms as well as payer and health care provider channels.

Organon has what we believe to be a truly integrated go-to-market plan targeting all of the key stakeholders which are the health care providers, the payers and the patients in order to quickly drive interest and awareness in the brand. And importantly, we have reported previously Organon’s market access team has been meeting with health plans and PBMs to review XACIATO and obtain competitive coverage in the bacterial vaginosis category which is critical to support patient access and product pull-through, as Sabrina mentioned earlier. Organon will leverage its established Nexplanon sales team to optimize XACIATO uptake at launch. And they believe there’s roughly a 90% overlap of those health care providers who are already prescribing Nexplanon and have the potential to be XACIATO prescribers.

That strong relationship with the sales team and the provider relationships they have in place is expected to enable access to these HCPs and coupled with Organon’s payer outreach and planned patient-centered activities, we think that allow us to be well positioned for in-market success and we look forward to launching the brand by the end of the second quarter. Under our license agreement with Organon to commercialize XACIATO, we received a $10 million cash payment from Organon after the license became effective in June and we are entitled to receive $2.5 million following the first commercial sale. We are also eligible to receive potential additional milestone payments of up to $180 million as well as tiered double-digit royalties based on net sales.

Let me transit announce on pre-commercialization activities underway for Ovaprene, our novel hormone-free monthly intravaginal contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer. As a reminder, as part of our license agreement with Bayer to commercialize Ovaprene in the U.S., Bayer currently supports the Ovaprene program by providing up to 80 hours per week of an advisory capacity giving Daré access to Bayer’s extensive clinical, regulatory, manufacturing and commercialization resources while we retain control over Ovaprene’s development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize Ovaprene in the U.S., following the completion of a pivotal Phase III study by making a $20 million payment to Daré.

Thereafter, we will be entitled to receive commercial milestone payments potentially totaling $310 million in addition to double-digit tiered royalties based on net sales. Bayer has initiated activities to gain meaningful market and key stakeholder insights. Bayer continues to be a great collaborator, including recently sharing important commercial input that we were able to leverage for the Phase III study design. And with that, I’ll turn it over to Lisa for a financial update.

Lisa Walters-Hoffert: Thank you, John and thanks, everyone, for joining us today. I’d now like to summarize Daré’s financial results for the year ended December 31, 2022 which I will also refer to as the current year or 2022. Daré’s business model is comprised of 2 parts. The first is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs we’ve identified in women’s health. The investment required to do so includes corporate overhead, portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses. The second part of our model involves monetizing the value of the portfolio’s clinical and regulatory advances over the near and long term.

There are many ways to generate value from a portfolio and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones and royalties on net sales. This is the arrangement we put in place for XACIATO. And as John just outlined, pursuant to the terms of our global license agreement with Organon for XACIATO, we’ve already received $10 million upfront upon the agreements effectiveness and we will be entitled to receive a milestone of $2.5 million following the first commercial sale. And thereafter, we will be eligible to receive potential additional milestones of up to $180 million and tiered double-digit royalties on net sales. But back to our current year. During 2022, we recognized our first revenue from the $10 million license fee from Organon that I just mentioned.

Our general and administrative, or G&A, expenses were approximately $11.2 million. Our R&D expenses across our entire portfolio which vary from period to period based on our clinical, preclinical manufacturing, regulatory and other activities, they were approximately $30 million and primarily reflected the costs of our late-stage programs, such as the ongoing Sildenafil Cream, 3.6% Phase IIb RESPOND clinical trial and manufacturing and regulatory affairs activities related to Ovaprene. Our comprehensive loss for 2022 was approximately $31.1 million. We ended 2022 with approximately $34.7 million in cash and cash equivalents. During the year, we received approximately $24.1 million in nondilutive funding. This included the $10 million license fee from Organon, approximately $13.3 million in grant funding and approximately $800,000 from an Australian government — from the Australian government as a research and development cash rebate from clinical studies that we have performed in 2021.

Grant funding consisted primarily of funding for the Daré-LAT1 program under a 2021 brand agreement and for the DARE-LVT1 program under a November 2022 grant agreement. But also, in addition to those sources, our brand funding included an NICHD funding for the Daré 204 214 and DARE-PTB1 program. As we’ve said before, nondilutive sources have and will continue to play a very important role in our funding strategy. Our with the NICHD will allow Daré to share cost of the upcoming Ovaprene pivotal study and to tap into the NICHD’s extensive experience in conducting contraceptive studies. Under our existing crater, we are responsible for providing clinical surprise of Ovaprene for the study, coordinating interactions with the FDA, preparing and submitting supporting regulatory documentation and providing a total of $5.5 million to the NICHD to be applied towards the cost of conducting the pivotal study, $5 million of which has already been paid.

NICHD is responsible for other costs related to the conduct of the study. As of December 31, 2022, we had outstanding warrants issued in February of 2018 that were exercisable for up to approximately 1.4 million shares of our common stock. Subsequent to the end of the year, all of those warrants were either exercised or have expired. And today, none of those warrants are expanding. We received approximately $1.3 million in cash and issued approximately 1.4 million shares as a result of such warrant exercises. As of March 28, 2023, Daré had approximately 86.2 million shares of common stock outstanding. In closing, we will endeavor to be creative, collaborative and opportunistic in seeking the capital necessary to advance our candidates and to 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 on our Form 10-K for the year ended December 31, 2022 which we filed this afternoon. I would now like to turn the call over to the operator.

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Q&A Session

Operator: Your first question comes from the line of Catherine Novack from Jones Research.

Catherine Novack: Congrats on all the progress. Just thinking about the upcoming RESPOND data, can you talk about the different components that are going into the arousal sensation domains in both of the primary composite endpoint for both the SFQ 28 and the SBSBAO, what would be considered a clinically meaningful improvement on some of these endpoints? And then again, thinking about this patient population, what proportion of women with FSIID would fall under the category that you’re enrolling into the Phase IIb?

Sabrina Johnson: Great question. And thank you for the kind words about our accomplishments. So let’s start first with the questionnaires and the nature of the question specifically in those primary endpoints. And that’s a great and what’s clinically meaningful, right? That’s a great place to kind of take a step back. And again, explain what the use of this study is, right? And what we’re trying to do here. And you just highlighted one of them. So in any clinical trial, you can only use as your primary endpoint, something that has already been validated. And in the place of sexual health, there are not a lot of validated questionnaires for women, not surprisingly, given that there haven’t been a lot of sponsor programs, right, to take products through the FDA.

But the endpoints you highlighted, those questionnaires have been and those questionnaires on the sexual functioning questionnaire, it does have a subset of questions. It has questions about pretty much everything you can imagine that happens in a sexual experience all across the journey. And some of those questions are very specific to what you would experience as part of a genital arousal response, right? Those — their questions specifically about what happens in the genital region, specifically actually when you get blood flow to the region because that’s what elicits that those sensations that you — that she could experience. So it does have some questions that are very relevant, right, to what Sildenafil does. And the distressed questionnaire that we use, the definition, right, the arousal condition definition includes the fact that this lack of an inability to attain or maintain sufficient general arousal response can lead to distress.

And so there is — therefore, as part of the co-primary and specific question about distress. Because these questionnaires have not been used before, in the context of arousal disorder, there is an opportunity for us on the primaries as well as actually on all of our exploratory endpoints. So we included a number of exploratory endpoints in this study that specifically came out of what’s called content validity work we did with women with the condition to understand the words they use specifically to talk about it and the symptoms they care about and what they might feel is a clinically meaningful improvement. So all of that was included in the Phase IIb as well as a whole component that has to do with exit interviews as well as psychometric work that had after we have all the study data that is important to do exactly what you just asked about, to demonstrate what amount of improvement is considered clinically meaningful and to validate any of the endpoints that we have included here so that any of the endpoints we have included here are candidates for the Phase III.

And that is why I say. So this is a super exciting study. It’s a very rich study in terms of the data that we are going to be generating which is why I say we will make a top line data announcement, obviously, as soon as we have this data in the second quarter but there will definitely be a deeper dive assessment as we do exactly what you’ve outlined. Then we take all that information, we take the exit interviews that we’re done, we take what we have demonstrated to be a clinically meaningful improvement and we pick what do we want to take forward in Phase III and why. And that’s a great tie-in to the second part of your question which is how does our population, patient population, how does the endpoints you’re looking at, right? How does that all relate to different definitions and different populations within the arousal disorder community because the nomenclature and how that condition is defined like in the DSM which is where this condition is defined have continues to evolve.