Dare Bioscience, Inc. (NASDAQ:DARE) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET
Company Participants
Sabrina Johnson – President, CEO, Secretary & Director
John A. Fair – Chief Strategy Officer
Lisa Walters-Hoffert – CFO
Conference Call Participants
Operator
Good . My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the Dare Bioscience, Inc. Q2 2022 Conference Call. [Operator Instructions]. Ms. Johnson, you may begin your conference.
Sabrina Johnson
Wonderful. Thank you. Good afternoon, and welcome to our Second Quarter 2022 Financial Results and Business Update Call for Dare Bioscience. Our plan today is to review our second quarter results, discuss development since our last call in May and use the time to review our business strategy and highlight our objectives and milestones anticipated for the rest of 2022.
Before we begin, I would 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 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, 2021, which was filed on March 31, 2022, and our quarterly report on Form 10-Q for the quarter ended June 30, 2022, 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, August 9, 2022. Dare undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.
As you know, Dare is solely and squarely focused in women’s health. It is our belief that prioritizing women’s health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their families and partners and, of course, our shareholders. We work to accelerate innovative differentiated product options in contraception, vaginal health, sexual health and fertility, that expand treatment options were not exist, but enhanced outcomes where current standard of care has meaningful shortcomings and that improve ease of use for women where a more compelling form factor can drive adoption. Why? Because these are compelling markets impacting millions of women, and we have seen that innovation in these areas has led to commercially successful brands.
Let’s look at contraception. There are 73 million women in the U.S. ages 15 to 49 and the first monthly intervaginal ring contraceptive, NuvaRing peaked at $900 million annual revenue. The first hormone releasing intrauterine system contraceptive, Mirena peaked at $1.2 billion. And what about menopause? There are 47 million new entrants to the menopause and postmenopausal market each year, the first estrogen hormone therapy, Premarin peaked at $2 billion in annual revenue. And how about arousal problems? There are 10 million women estimated to have arousal problem significant enough to seek treatment.
Now while we can’t point to the success of the first product for women yet, since there is no FDA-approved product for female sexual arousal disorder. The first product for the analogous male condition erectile dysfunction, Viagra peaked at $2 billion in annual sales. Novel products that provide new features and flexibility have the potential to become meaningful brands. So what are the next big ideas in women’s health?
Well, at Dare, we believe these are the 4 novel contraceptive candidates or potential candidates in our portfolio. The first hormone-free monthly contraceptive candidate, Ovaprene, first 6- to 12-month injectable ADARE-204/214, first long-acting reversible contraceptive system, DARE-LARC1, and the hormone-free contraceptive target for men and women, DARE-RH1. We believe it’s a 3 vaginal health programs in our portfolio, our FDA-approved product, XACIATO, clindamycin phosphate vaginal gel, 2% treatment for bacterial vaginosis in a single-dose vaginal administration.
Our product candidate, DARE-HRT1, the first hormone therapy, bioidentical estradiol and progesterone monthly intravaginal ring and our product candidate, DARE-VVA1, the first hormone-free vaginal atrophy therapy for women with hormone receptor positive breast cancer. We believe it’s a sexual health product candidate in our portfolio, the first topical cream with the same active ingredient as Viagra being evaluated as potential first-in-category treatment for female sexual arousal disorder or FSAD. And the pregnancy management product candidates in our portfolio, DARE-FRT1 and DARE-PTB1, IVR designed to release bioidentical progesterone over 14 days.
So yes, it’s our belief that prioritizing women’s health is good for the many women lacking effective or convenient therapeutic choices and good for a broad set of stakeholders, including their families and partners and yes, of course, our shareholders. And it’s our belief that the programs in our portfolio represent a compelling opportunity overall, given that strategic partners are looking for meaningful market potential for differentiated products. Providers are looking for first line and first-in-category product opportunities to address unmet patient needs. And investors are looking for a diverse pipeline with independent outcomes to mitigate risk and enhance the overall commercial opportunity. And women will continue to seek innovative options to help them navigate their needs and preference over the course of a lifetime.
The Dare portfolio is built on these core principles, meaningful market opportunities, product candidates for women with first-line or first-in-category potential and a highly diversified pipeline that often leverages well-known and well-characterized active pharmaceutical ingredients or API. And a great example of the execution of these core principles can be found in our FDA-approved product XACIATO. In the case of XACIATO, use of a well-characterized API mitigated the development risk, the time and cost as compared to new molecular entities. As with XACIATO, that 505(b)(2) regulatory pathway that’s possible for non-new molecular entities is planned for most of our development candidates. Why is that important? Well, 505(b)(2) candidates have a 23% probability of success of advancing from Phase I to approval in a 67% likelihood of success advancing from Phase III to approval versus just 6% and 38%, respectively, for new molecular entities.
And let’s talk about multiple delivery platforms. Persistent unmet needs require creative new approaches designed for her. Novel delivery platforms allow us to configure the most relevant API for the condition in a dosage form and delivery duration that has an opportunity to improve outcomes. This can lead to first-in-category products while using that well-characterized API, that allows us to use that 505(b)(2) regulatory pathway. The commercial value in women’s health has been evidenced by differentiated brands and recent transactions in the category. Anyone following the category knows that women are often the most frequent consumers of health care. They manage 80% of the health care dollars in the household. Recent transformational pharma transactions are a good reminder of the global opportunity for differentiated women’s health brands.
We continue to drive our portfolio forward to deliver value as evidenced by our anticipated milestones. The milestones we expect our programs to achieve in 2022 alone include a product launch, a Phase III initiation, and we have 2 data readouts will be the focus of our call today. Specifically, in terms of the milestones, XACIATO, the clindamycin phosphate vaginal gel, 2% for bacterial vaginosis. We have that commercial launch planned and targeted for the fourth quarter of this year. So more on that to follow.
Ovaprene, our hormone-free monthly contraceptive, were talked about the IDA approval process in the pivotal Phase III study commencement that’s planned for the fourth quarter this year. VVA1 our vaginal atrophy program treatment for women with breast cancer. That’s one of the Phase I/II study top line data readouts anticipated this year for the fourth quarter. DARE-HRT1, a hormone therapy for the treatment of menopausal symptoms. That Phase I/II study top line data is anticipated fourth quarter this year; and Sildenafil Cream, our female sexual arousal disorder program, the Phase IIb study top line data target data announcement is pending an interim analysis for study sizing, which is planned for this year.
So shortly, I’ll turn the call over to John to provide an update on the collaboration with Organon to commercialize XACIATO and the launch targeted for later this year as well as to provide an update on various of the anticipated program milestones this year. But first, I want to address some questions we’ve received regarding Ovaprene and particularly to provide some perspective on our IDE-related discussions with the FDA. As I mentioned, we’re targeting commencement this year of what we expect to be the single pivotal Phase III study necessary to support a premarket approval or PMA submission to the FDA.
In order to initiate the pivotal Phase III study, we must have an FDA-approved IDE in place. We initiated the IDE process for Ovaprene in early 2022. You may remember that the device division of the FDA is leading a review of Ovaprene. There is no predicate device for Ovaprene in that there is no existing FDA-approved product that the FDA can use to compare with Ovaprene. As such, Ovaprene will be reviewed via a PMA and not a 510(k) submission. While the regulatory process for such a novel product via a PMA can require more interactions and research to support the approval, the benefit is a clearly differentiated product.
We’ve seen firsthand how challenging the contraceptive payer process can be and also pleased to be working on such a clearly differentiated product. Even if it means more FDA discussions and time to prepare for the pivotal study than would be required if Ovaprene were not so clearly differentiated. Those of you following the company, the last couple of years may recall that we’ve been utilizing the presubmission process with the FDA to align with the FDA on certain biocompatibility, chemical characterization and animal studies to support the safety profile of Ovaprene, such as a 9-month sheet study, which was completed and demonstrated the safety of Ovaprene over several months of use.
We’ve also been discussing the Phase III study protocol with the FDA and Bayer, our commercialization collaborator from Ovaprene has contributed to these and other discussions with the FDA. Based on these ongoing interactions with the FDA and the IDE process for Ovaprene that we initiated in early 2022, we anticipate continuing the IDE process into the third quarter and subject to the FDA’s approval of the IDE, we are targeting the investigator meeting for the fourth quarter of 2022, that preparatory step to commence the pivotal study based on communications with the FDA in terms of study sample size and duration, we expect that at least 200 subjects completing 12 months of Ovaprene use will be adequate.
The Phase III study will be conducted under our cooperative research and development agreement, or CRADA, with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the National Institute of Health or NIH. We look forward to collaborating with the NIH and Bayer on the ongoing development of this potential first-in-category contraceptive.
With that, I will now turn it over to John for additional portfolio updates.
John Fair
Thanks, Sabrina. Given the stage of our current portfolio and market dynamics in the therapeutic categories, specific to XACIATO and Ovaprene, we believe the best avenue to generate value for Dare and its shareholders is via external commercialization collaboration or out-license agreements rather than attempting to commercialize these assets on our own. Opportunity to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first in category.
So let me begin with bacterial vaginosis and our first FDA-approved product XACIATO. As we’ve mentioned on previous calls, bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to impact approximately 21 million women in the U.S. The condition is a result of an overgrowth of bacteria, including Gardnerella vaginitis, an anaerobic bacteria, which disrupts the balance of natural vaginal microbiome and can result in symptoms such as vaginal odor and discharge.
Organon, our global collaborator for XACIATO, shares our commitment to advance critically needed innovations in women’s health, and we believe that Organon’s unique focus on women’s health, coupled with their strong commercial capabilities, will ensure that XACIATO reaches the women most impacted by this condition. We believe that Organon is uniquely positioned to bring XACIATO to market and drive patient and provider awareness and utilization of XACIATO based on its unique and differentiated product characteristics.
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 also eligible to receive potential milestone payments of up to $182.5 million as well as tiered double-digit royalties based on net sales. XACIATO is expected to be available commercially in the U.S. in the fourth quarter of this year.
While we are still very early in our collaboration, Organon, our experience with the various Organon functional teams, including sales and marketing, market access and really the broader commercial leadership team has been overwhelmingly positive. We have been collaborating with Organon to accelerate the integration of the XACIATO brand into their larger women’s health franchise and Organon is very focused and highly driven commercial organization in our . We will be in a better position to provide you with more substantive commercial updates after the product launches, but I can assure you that our team is very pleased with the level of effort organized putting into building the XACIATO brand.
So let me transition now to commercial activities underway for Ovaprene, our novel hormone 3 monthly 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, Dare has access to Bayer’s extensive clinical, manufacturing and commercialization resources in an advisory capacity for approximately 80 hours per week, while Dare retains full control over overprints development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize Ovaprene in the U.S. following the completion of the pivotal Phase III study by making a $20 million payment to Dare. Thereafter, Dare is entitled to receive commercial milestone payments potentially totaling $310 million in addition to double-digit tiered royalties on net sales.
And as Sabrina noted earlier, Ovaprene is a distinct and novel form of contraception without an FDA-approved predicate and without a generic equivalent. Bayer has proactively initiated pre-commercialization activities, including discussions with payers, providers and women and their commercial team is uniquely focused on identifying the key drivers and points of differentiation that will resonate with payers, providers and patients. Many of you know that Bayer has a unique leadership position in the hormonal contraceptive category with the Mirena franchise, and they’re looking to establish a similar leadership position in the hormone-free category with Ovaprene. They are actively engaging payers and providers to gain meaningful insights into the best way to position Ovaprene to maximize market uptake.
Turning now to Sildenafil Cream, our investigational product to address female sexual arousal disorder, which as Sabrina mentioned, is really akin to her version of erectile dysfunction. FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. Currently, there are no FDA-approved therapeutics for this condition, which means our Sildenafil Cream has the potential to be the first and only FDA-approved product in the category. As we previously mentioned, we started the Phase IIb RESPOND clinical study in 2021, evaluating Sildenafil Cream as a potential new treatment for FSAD at sites across the country.
The immediate interest in the study was so overwhelming that there were over 10,000 online inquiries about the study in the first few months post initiation. As this is a first of its kind Phase IIb study, we want to be best positioned to learn as much as we can about the endpoints being evaluated and the characteristics of women most responsive to Sildenafil Cream. As such, we’ve been cautious and thoughtful relative to our enrollment criteria characterizing each subject and her partner via a series of medical exams, interviews and screen periods. We are continuing to enroll women in the study at a deliberate pace.
We believe that there are thousands of women that will be exceptional candidates for this product, if it’s approved, but are not optimal candidates for the Phase IIb program since as many of you know, are aware, investigational studies place more demands on subjects than would otherwise be expected with an approved product. Our study protocol has a planned interim analysis to evaluate the confidence interval in trial sizing, and we expect to conduct that analysis this year, after which we’ll provide guidance on the anticipated timing for top line data from this trial.
Turning our attention to DARE-HRT1, our investigational, intervaginal ring or IVR designed to deliver bioidentical estradiol and bioidentical progesterone continuously over a 28-day period as part of a hormone therapy regimen. As you may recall, we announced positive top line results from the Phase I study of DARE-HRT1 in 2021. And in April 2022, we announced the start of a new Phase I/II study clinical study. This open-label study will evaluate PK of lower and higher dose versions of DARE-HRT1, the same 2 versions evaluated in the first Phase I study in approximately 20 healthy postmenopausal women over approximately 3 consecutive months of use. And incidentally, many of the women that are participating in this study also participated in the first Phase I study.
In addition to PK data, this study will also collect safety, usability, acceptability and symptom relief data, giving us a more robust data package and providing us with some preliminary evidence of efficacy. As with the previous study, this study is being conducted in Australia through Australian subsidiary to take advantage of the clinical and financial benefits of doing so. We expect to report top line data from this Phase I/II study during the fourth quarter of 2022.
Finally, we can turn our attention to DARE-VVA1. As previously noted, more than 3.8 million women in the U.S. have a history of breast cancer or are considered survivors. Hormone receptor positive breast cancer is the most common type of breast cancer diagnosis and the prevalence of vulvar and vaginal atrophy, or VVA, in postmenopausal breast cancer survivors is estimated to be between 42% and 70%. Currently, there are no FDA-approved products to address this very challenging condition in this very important patient population, and we would like to provide a new first-in-class option for these women.
DARE-VVA1 is our proprietary investigational formulation of tamoxifen for the vaginal administration treatment of VVA and as a nonhormonal approach to addressing VVA, it could be an important new prescription option for women with a history of or at risk for hormone receptor positive breast cancer as many of these women are not ideal candidates for standard estrogen-based interventions. We initiated the Phase I/II study in Australia earlier in this year in the third quarter of 2021 for breast cancer survivorships in the program. We’ll have an update for you by the end of this year. And we expect to report top line data for this, as I mentioned, in the first — excuse me, Phase I/II study during the second half of 2022 later this year.
So in terms of near-term catalysts, we look forward to keeping you updated on the launch of XACIATO, our FDA-approved product for the treatment of bacterial vaginosis, our collaboration with Organon, who is a global leader in women’s health, our pivotal study start for a potential first-in-category contraceptive program, Ovaprene, which is subject to a license agreement for commercialization in the U.S. with Bayer, who maintains a global leadership position in contraception as well as 2 data readouts from our Phase I/II DARE-HRT1 program and our DARE-VVA1 program.
I will now turn the call over to Lisa to provide a financial update.
Lisa Walters-Hoffert
Thank you, John, and thanks, everyone, for joining us today. I would now like to summarize Dare’s financial results for the quarter ended June 30, 2022, which I will refer to as the current quarter or the second quarter of 2022. Dare’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 that we’ve identified in women’s health. The investment required to do this 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 our portfolio’s clinical and regulatory events over the near and long term. There are many ways to do this and generate value from products with differentiated outcomes and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones and royalties on net product sales.
For Dare, this occurred during the second quarter of 2022, when we recognized revenue of $10 million from the upfront license fee due in connection with the closing of our global license agreement for XACIATO with Organon. As my colleagues have mentioned, Dare will be entitled to receive additional milestones and royalties once XACIATO is commercially launched. But back to the current quarter.
Our general and administrative or G&A expenses were approximately $2.8 million. Our R&D expenses, which vary from quarter-to-quarter based on our clinical, preclinical manufacturing, regulatory and other portfolio activities were approximately $6.8 million. The current quarter’s R&D expenses were actually about $0.5 million less than the comparable period for 2021 and primarily reflected the cost of the ongoing Sildenafil Cream Phase IIb RESPOND clinical trial and manufacturing and regulatory affairs activities related to Ovaprene.
We ended the current quarter with approximately $32 million in cash and cash equivalents. Then in July, we received additional cash payments of $18 million, representing the $10 million license fee from Organon and a cash disbursement of approximately $7.9 million under our existing grant to fund the DARE-LARC1 program. As touched upon earlier, under our license agreement with Organon, we will be entitled to receive a cash payment of $2.5 million upon the first commercial sale of XACIATO and here double-digit royalties based on net sales. Again, the launch is expected to occur in the fourth quarter of 2022. And thereafter, in addition to the ongoing net sales royalties, Dare will also be eligible to receive future milestones of up to $180 million in the aggregate based on commercial sales and other developments.
Now during our quarterly calls, we’ve highlighted the importance of nondilutive sources of funding to our strategy. These include grants, collaborations and tax credits. The $7.9 million payment received in July is part of a larger grant established to finance the development of our novel DARE-LARC1 program over multiple years. In addition, we have received other grants in varying amounts from the NIH and the NICHD to fund a variety of development and market research activities related to Ovaprene, DARE-LARC1, ADARE and DARE-PTB1.
In terms of collaborations, our with the NIH allows Dare to share the cost of the Ovaprene pivotal study with the NIH and also did tap into the NIH’s extensive experience in conducting contraceptive studies. And finally, in connection with our studies being conducted currently in Australia, we will continue to apply and receive partial reimbursement for our eligible R&D expenses, which is currently up to 43% of eligible expenses occurred in Australia for those studies.
As of August 8, 2022, Dare had approximately 84.8 million shares of common stock outstanding. shareholders recently approved an increase in our authorized shares to . We want to thank you for your approval of this proposal at our 2022 annual meeting as that will allow us to explore and potentially pursue financing and other transactions using shares of our common stock over multiple years in the future as opportunities arise.
But in closing, to reiterate before we will endeavor to be creative, collaborative and opportunistic in seeking the capital necessary to advance our candidates 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 June 30, ’22, which was filed today, as well as our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022.
I would now like to turn the call back over to the operator for questions.
Question-and-Answer Session
Operator
[Operator Instructions]. And your first question comes from the line of Douglas Tsao with H.C. Wainwright. Your next question comes from the line of Kumar Raja with Brookline Capital Markets.
Unidentified Analyst
I’m for Kumar. Can you share any insights updates regarding the trial? Like how are the patients responding, the safety profile? Whatever you can share?
Sabrina Johnson
So the VVA1 trial is our Phase I/II study that’s going on right now in Australia for our vaginal atrophy program. And just to give you a little more perspective on maybe what that trial is, right, and what we’re looking at in that trial. So first of all, that the active that we’re studying in that case is actually tamoxifen, which is a — as I mentioned earlier, a known chemical entity, that is often used as part of a breast cancer treatment regimen, in this case is being delivered vaginally. And the reason why is tamoxifen has a really interesting profile. It acts as an estrogen antagonist in the breast, but an estrogen agonist vaginally. So it makes it a really interesting chemical entity to consider for this condition.
And prior to the Phase I/II study, there was actually a proof-of-concept study that was run just using a not necessarily optimally formulated vaginal tamoxifen, but looking at tamoxifen delivered vaginally and specifically in that proof-of-concept study that’s been published and they got us really excited about the opportunity. What they showed was some important improvements. So they showed improvements in vaginal pH. So that’s often one of the challenges with vaginal atrophy, the vaginal pH rises, and that can lead to other complications in terms of the vaginal microbiome. And also improvement in vaginal dryness.
And so since that really exciting proof-of-concept study, what we have done is obviously worked to optimize the formulation. And then in this Phase I/II study, we’re actually looking at women — a cohort of women, including women with a history of breast cancer. And we’re actually looking at a number of different treatment groups. So we’re looking at 4 different dose levels and placebo. And so these women will be able to self-administer the product, it comes in sort of a vaginal gel cap is the best way to describe it. They all self-administered intravaginally once a day for the first 2 weeks and then twice a week for the following 6 weeks for a total treatment period of 56 days. So we’ll get some nice data over that period of time.
And then part of the analysis, to your question of what will we be sharing. So part of it is we’ll be looking at the pharmacokinetics, a very traditional kind of approach that you would take with any kind of Phase I study. We’ll obviously be looking at safety and tolerability. So we’re looking because this is administered vaginally, you look for any sort of vaginal effects as well, as well as just the safety systemically as well. But again, we’re using a much lower dose than what’s typically administered orally.
But the secondary endpoints will really look at that preliminary efficacy of the formulation. In terms of a couple of things. So we are asking these women in the Phase I/II study to tell us what their most bothersome symptom is. So for some women, it is the dryness for some women, it’s painful intercourse. So we have asked them when they enroll in the study with their most bothersome symptom is because these are symptomatic women. So we will be looking to see if any changes in the most bothersome symptoms. And then importantly, kind of similar to that proof-of-concept study that was run, we will be looking at things like vaginal cytology and PH, which are really important determinants of success in managing vaginal atrophy.
So that’s why it’s really a Phase I/II study. It’s not powered for efficacy per se. But because these are all symptomatic women, we should be able to get a really nice sense of how they’re doing on the product. So those are the kind of data that we’ll be able to report when we do the top line data readout in the fourth quarter. So hopefully, that was a helpful answer to your question.
Unidentified Analyst
One more — one question regarding the — like could you provide some color to the rate of enrollment in the ongoing HRT1 trial? Like how many sites do you have activated? And do you plan to add more sites to it?
Sabrina Johnson
Yes. So the HRT1 study is — and similarly, is a Phase I/II trial, evaluating our vaginal ring for hormone therapy. We have already completed a Phase I study, which I point out simply because the study that we’ve already completed is relevant to your question a couple of ways. So first of all, the study that’s already been completed with HRT1 really already demonstrated the PK profile and importantly, demonstrated its potential to be effective in both the vaginal atrophy as well as the vasomotor symptoms of menopause because we looked at — we know the therapeutic dose levels of those hormones. And so that has already been demonstrated.
What we wanted to do in this study is give women an opportunity to actually use the product for 3 months in a row with a 28-day vaginal ring. So 3, she’ll get to use it 3 different times, 3 different rings over the course of 3 months, and we are looking at the same 2 doses again. It’s about 20 women. They are all postmenopausal. So again, these are women that are in menopause. And so similarly to what I talked about with the VVA1 study, we’ll be looking at safety, usability, acceptability as well as symptom release data. So very similarly, we’re asking them about their most bothersome symptoms of menopause before they come in and then we’re going to ask them how they’re doing, after 3 months of using the product. So again, not powered for efficacy, but will give us some nice signs.
In terms of the site, we do a number of our Phase I studies in Australia, very cost effective, right, because of the Australian R&D cash rebate. And we actually have a few sites, and Australia is not huge. So we have a few sites that we work with across our studies in Australia, so it’s the same sites. And as John mentioned in his comments, what we found quite interesting, and I think it says a lot about the product is women who had been in the prior Phase I asked the — at the end of that study, said, “My gosh, can’t we just keep using this? No, you can’t. But they asked to be notified of any future study. So many of the participants in this study already had experience with the product because they were in the prior — prior Phase I study. So we don’t need to really add any additional sites. So at this point, we’re following the subjects in the trial, and then we expect, as I mentioned, that top line data readout in the fourth quarter.
Operator
[Operator Instructions]. There are no further questions. I will now turn the call back over to Ms. Johnson for closing remarks.
Sabrina Johnson
Great. Well, thank you so much for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of our stakeholders, the women, the health care providers and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that really prioritize women’s health and well-being and expand those treatment options where not exist, enhance the 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 as we’ve been discussing of contraception, vaginal health, sexual health and facility and where we think there are really compelling market opportunities.
Today, we have 7 candidates in various stages of development and 1 FDA-approved product expected to be launched commercially in the fourth quarter of this year. So we look forward to keeping you updated on our progress against the important 2022 objectives and milestones we set for all of our candidates under development as well as the activities with Organon regarding the XACIATO launch. So thank you for tuning into the call today and for all of your support.
Operator
This concludes today’s conference call. You may now disconnect.
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