Dare Bioscience, Inc. Q4 FY2021 Earnings Call

Welcome to the conference call hosted by Daré Bioscience to review the company's financial results for the year ended December 31, 2021, and to provide a general business update. This call is being recorded. My name is Catherine, and I'll be your Operator today. With us today are Sabrina Martucci Johnson, Dare's President and Chief Executive Officer, John Fair, Dare's Chief Strategy Officer, and Lisa Walters-Hoffert, Dare's Chief Financial Officer. Ms. Johnson, please proceed.

Thank you. Good afternoon, and welcome to our full-year 2021 financial results and business update call for Daré Bioscience. Our plan today is to review last year's results, discuss developments since our last call in November, and use the time to highlight objectives and milestones anticipated for 2022 as well as other insights for the year. 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 fact 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 is 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 31, 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. Dare is solely and squarely focused on 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, partners, and of course our shareholders. Our strategy involves identifying areas of high unmet need, selecting promising candidates to address such needs, conducting research and development activities in a thoughtful and capital-efficient manner, and developing an appropriate commercialization strategy for each candidate with the goal of reaching as many potential users as quickly as possible. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and well-being, expand treatment options, and improve the outcomes primarily in the areas of contraception, fertility, and vaginal and sexual health. Today, we have seven candidates in various stages of development and one product that has received FDA approval last December. We're going to spend much of our time today providing an update on our late-stage development candidates and our FDA approved product. As it pertains to that FDA approved product, XACIATO, we look forward to reviewing the announcement we made today regarding the global license agreement we entered into with Organon to commercialize XACIATO, which is Clindamycin Phosphate vaginal gel, 2%, our FDA approved treatment for females 12 and older with Bacterial Vaginosis. Before we discuss XACIATO in our late-stage program such as Ovaprene, I want to first review the many factors we consider when evaluating new potential candidates for our portfolio. Since those factors ultimately impact the commercialization strategies for those products and opportunities to enter into collaboration such as those that we have established to date with Organon for XACIATO and Bayer for Ovaprene. Key considerations include the following: candidates must have the potential to be a first-line or first-in-category option; candidates must represent a meaningful commercial revenue opportunity; we ideally seek product candidates to utilize differentiated and diverse APIs and target different indications or drug delivery modes that are personalized for her; and finally, we are particularly fond of candidates that can be developed via a 505B2 regulatory path or have existing proof of concept allowing us to move quickly to later stages of clinical development, potentially shortening the overall development time and cost to obtain marketing approval in the U.S., as was the case with XACIATO where we achieved FDA approval just three years after acquiring rights to the program. Now, before we look forward to what is ahead in 2022, I'd like to take a moment to highlight a few important achievements during 2021 since those achievements set us up for where we are today and what is yet to come. We were awarded a grant for up to $48.9 million over approximately five years to support our preclinical DARE-LARC1 contraceptive program. The FDA accepted our NDA for DARE-BV1, which is now referred to as XACIATO, and the FDA subsequently approved our application on the scheduled PDUFA date of December 7, 2021. We entered into a collaborative research and development agreement, or CRADA, under which a pivotal Phase III clinical study of Ovaprene will be supported financially by NICHD's Contraceptive Development Program and conducted within its contraceptive clinical trial network. We continued our collaboration with Bayer, who has the commercialization rights for Ovaprene. We initiated the Phase 2b RESPOND study evaluating Sildenafil Cream 3.6% as a treatment for Female Sexual Arousal Disorder, her equivalent of erectile dysfunction, for which there are no current FDA approved treatments. We initiated a Phase 1/2 clinical study of DARE-VVA1, our proprietary investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy in women at risk for hormone receptor positive breast cancer. Finally, we generated positive Phase 1 clinical data for DARE-HRT1, our investigational hormone therapy vaginal ring for the treatment of both the vasomotor and vaginal symptoms associated with menopause. Now, let's talk about Bacterial Vaginosis, our FDA approved treatment, XACIATO, and our global license agreement with Organon to commercialize XACIATO. First, the unmet need. Bacterial Vaginosis is the most common vaginal condition and the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the United States. The condition results from an overgrowth of bacteria which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. XACIATO has both qualified infectious disease product (QIDP) and fast track designations from the FDA for the treatment of Bacterial Vaginosis. Organon shares our commitment to advance critically needed innovation in women's health. We are excited to be collaborating with one of the premier companies in women's health, as we believe that Organon's commercial capabilities will ensure that XACIATO reaches the women most impacted by this condition. Through Organon's strong commercial capabilities and expertise in women's health, Organon is uniquely positioned to bring XACIATO to market and enable women across the U.S. to access this important option. Under the terms of the agreement, we will receive a $10 million upfront payment from Organon. We are eligible to receive potential milestone payments of up to $182.5 million and 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. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions, and the transaction is expected to close in the second quarter of 2022. I will shortly turn the call over to John to share some additional insights regarding our collaboration strategy and objectives in selecting Organon as our commercialization collaborator for XACIATO. But before doing so, I'll briefly provide updates on certain development milestones and objectives this year for our other programs. Ovaprene is our potential first-in-category option in the over $7 billion contraceptive category. It is our novel hormone-free monthly contraceptive candidate, whose U.S. commercial rights are under a licensed agreement with Bayer. In the third quarter of 2021, we announced the CRADA that I mentioned with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the NIH, for a pivotal Phase III study of Ovaprene. The CRADA reflects the NICHD's continued support for the development of Ovaprene and allows us to leverage the tremendous development expertise of the NIH in contraceptive clinical studies and to share the cost of the pivotal Phase III study with the NIH. The next stage of clinical development for Ovaprene is that pivotal Phase III contraceptive study that we will be conducting with them. In order to initiate the pivotal Phase III study, we must have an FDA approved IDE in place, and we initiated that IDE process for Ovaprene early this year. Pending the FDA's review and approval of the IDE, we hope to initiate the pivotal study this year. Under the license with Bayer, Dare received access to Bayer's extensive clinical and market expertise through approximately 80 hours per week in advisory support while retaining control over Ovaprene's development and regulatory approval process. Bayer has the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal trial by making a $20 million payment to Dare. We will also be entitled to receive commercial milestone payments potentially totaling $310 million, in addition to double-digit tiered royalties on net sales. Sildenafil Cream is our investigational product to address her version of erectile dysfunction. In March of last year, we commenced our Phase 2b study evaluating Sildenafil Cream 3.6%, our investigational cream formulation of Sildenafil, which is the active ingredient in Viagra for topical administration to treat Female Sexual Arousal Disorder (FSAD). FSAD is a physiological condition characterized by the inability to attain or maintain sufficient general arousal during sexual activity. Of the various types of female sexual dysfunction disorders, it is the most analogous to erectile dysfunction in men, and yet there is no FDA approved product that exists today to treat FSAD. If our clinical development is successful, Sildenafil Cream has the potential to be the first FDA approved FSAD treatment option. We continue to enroll women in the Phase 2b RESPOND clinical study evaluating Sildenafil Cream as a potential treatment for FSAD at sites located across the United States. Our study protocol has a planned interim analysis to evaluate the power calculations and trial sizing. Once we conduct that analysis, which is planned for this year, we will provide guidance on anticipated timing for the top-line data. Next, regarding DARE-HRT1. The results of the completed Phase 1 study of our investigational hormone therapy product, DARE-HRT1, last year demonstrated its potential as an effective hormone therapy for both the vasomotor and the vaginal symptoms associated with menopause. DARE-HRT1 is a unique vaginal ring designed to deliver bio-identical estradiol and bio-identical progesterone together continuously over a 28-day period as part of a hormone therapy regimen. As the next step in the development program, we are now commencing a Phase 1/2 clinical study of DARE-HRT1 in Australia in the second quarter of this year. This open-label study will evaluate the PK of the lower-end high-dose versions that we studied previously of DARE-HRT1 in approximately 20 healthy post-menopausal women over three consecutive months of use. The study will also collect safety, usability, acceptability, and symptom relief data. There are currently no FDA approved IVRs that deliver bio-identical progesterone in combination with bio-identical estradiol. As such, DARE-HRT1 has the potential to be a first-in-category product that offers monthly convenience for women. The last portfolio candidate I will discuss today is DARE-VVA1. More than 3.8 million women in the U.S. have a history of breast cancer. Hormone receptor positive is the most common type of breast cancer, and the prevalence of vulvar and vaginal atrophy in postmenopausal breast cancer survivors is estimated to be 40% to 70%. We would like to provide an option to those women. DARE-VVA1 is our proprietary investigational formulation of tamoxifen for vaginal administration to treat VVA. As a non-hormonal approach to addressing vaginal atrophy, it could be an important option for women with a history of or at risk for hormone receptor positive breast cancer. VVA is often an outcome of effective breast cancer treatments and can lead to vaginal discomfort, including painful intercourse, which can cause significant distress. For many women, an appropriate treatment for vaginal atrophy is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor positive breast cancer and hence DARE-VVA1 may offer a solution for these women and others for whom hormonal treatment is not an option. As I mentioned in my opening remarks, we initiated that Phase 1/2 clinical study in Australia in the third quarter of last year for what we refer to as this breast cancer survivorship vaginal atrophy treatment program, DARE-VVA1, and we expect to report top-line data from the DARE-VVA1 Phase 1/2 study during the second half of this year. Now, you've been waiting to hear more about XACIATO. I'm going to turn the call over to John to provide our perspective on commercialization and collaboration strategies in women's health.

Thank you, Sabrina. As Sabrina noted at the start of the call, we closed 2021 by achieving a number of important milestones for Dare. Chief among them was the FDA approval of XACIATO in December of 2021. As we communicated on our last call, we are a company focused on providing better therapeutic options for women and collaboration is core to our business model. In the context of XACIATO, our objective was to identify the right commercial collaborator for the product, specifically one with strong commercial capabilities and expertise in women's health, that would be in a unique position to bring XACIATO to market and leverage the clinical outcomes achieved in the Phase III clinical study. XACIATO uses a novel thermal setting gel formulation containing Clindamycin at a concentration of 2%, present as Clindamycin Phosphate with one-time dosing. In the Phase III trial, XACIATO demonstrated a clinical cure rate of 70% at the test of cure visit, the day 21 to 30 visit, as compared to 36% for placebo. The potential to offer women a new option for treating Bacterial Vaginosis enabled us to engage with the most capable potential partners in the women's health landscape, and we are excited that Organon will be leveraging its strong commercial capabilities and expertise in women's health to bring XACIATO to market. Organon's goal to deliver innovation, improve access, and expand choice to help address therapeutic gaps in women's health is clearly aligned with our mission and what we wanted to accomplish with XACIATO. Transitioning to Ovaprene. Our Ovaprene collaboration with Bayer has remained focused on activities to support the IDE process with the FDA, including manufacturing activities and importantly, pre-commercialization activities that inform the design of the pivotal study targeted to commence later this year and ultimately, the launch strategy for this potential first-in-category contraceptive candidate. We are fortunate to work with collaborators that share our vision to deliver innovation in women's health and have the access and expertise and sales capabilities to enhance our impact. I will now turn the call over to Lisa, who will give you a financial update.

Thank you, John, and thanks to all of you for joining us today. I would now like to summarize Dare's financial results for the year ended December 31, 2021, which I will refer to as fiscal 2021 or 2021. Dare's business model is to assemble, advance, and monetize a portfolio of novel product candidates in women's health. As a result, our expenses consist of corporate overhead, portfolio acquisition and maintenance costs, and research and development, or R&D activities. While our general administrative expenses tend to be somewhat predictable throughout the year, our R&D expenses will vary with our clinical, pre-clinical manufacturing, regulatory, and other activities related to advancing our portfolio candidates. For fiscal 2021, Dare's G&A expenses were approximately $8.4 million and our R&D expenses were approximately $30.6 million. The $9.8 million increase in R&D in 2021 compared with 2020 is primarily attributable to the cost of the ongoing Sildenafil Cream RESPOND clinical trial for Female Sexual Arousal Disorder, manufacturing and regulatory affairs activities related to Ovaprene, and development activities for our Phase 1 and Phase 1 ready programs. Our comprehensive loss for the year was approximately $38.8 million. During fiscal 2021, net cash proceeds from financing activities were approximately $75.8 million and primarily reflected sales of stock under our ATM program. We ended 2021 with approximately $51.7 million in cash and cash equivalents. I'd like to take a moment to highlight two interesting financing developments that occurred during 2021. In June, we entered into a grant agreement making us eligible to receive up to $48.9 million to support the preclinical development of DARE-LARC1 over the next five years. We received an initial payment of $11.5 million in July, and any future payments will be contingent upon DARE-LARC1 achieving specified development and reporting milestones. At year-end December 31, 2021, approximately $10.5 million was recorded as deferred grant funding liability under this grant agreement in our balance sheet. We are truly grateful to have been selected for a grant of this magnitude that covers multiple years of development work to advance this truly innovative technology. Second, in July, as Sabrina mentioned, we entered into the Cooperative Research and Development Agreement or CRADA with NICHD for the conduct of the Phase III study of Ovaprene. Dare agreed to contribute $5.5 million towards the total estimated cost of the pivotal study, and we paid about $5 million to date. Dare will also be responsible for providing the clinical supplies of Ovaprene for this study. For its part, NICHD will be responsible for the other costs related to the conduct of the pivotal study and will manage the payment of expenses to third parties. We truly believe NICHD's contraceptive trial experience and financial support should facilitate the completion of the Ovaprene pivotal study in an efficient and cost-effective manner. In terms of developments during the first quarter of 2022, as Sabrina and John just discussed, we were thrilled to announce a global license agreement with Organon for the commercialization of XACIATO. Again, Dare will receive a $10 million upfront payment from Organon, and Dare will be eligible to receive potential future milestones 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 2022. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is, however, expected to close in the second quarter of 2022. As of March 30, 2022, Dare had approximately 83.9 million shares of common stock outstanding. So in closing, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital that we need to advance our candidates and build shareholder value. As Sabrina noted at the beginning of the call, we encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources, and our risk factors in our annual report on Form 10-K for the year ended December 31, 2021, that was filed today. I would now like to turn the call over to the Operator.

Thank you. Our first question comes from Zegbeh Jallah with ROTH Capital Partners. Your line is open.

Hello, thanks for taking my questions, and congrats on the progress as well as the recently signed deal with Organon. I think everything looks like it is on track, so I'm just going to ask questions that a lot of folks have been wondering. I think the first is just about your decision to have Organon fully take over the commercialization as opposed to partnering with them on the commercialization, and then also your decision around perhaps giving them the right of first negotiation to some specified products.

Great questions, and thank you for asking about Organon and the decision. First of all, just taking a step back, it's always wonderful when you've developed a product and you have a vision of selecting product candidates that truly address persistent unmet needs and therefore have an opportunity to be first in line or first in category and have meaningful commercial potential. Thus they should be partnerable to actually, when you get to the finish line of an FDA approval, you have interest from parties in that product candidate. What that does is provide a lot of optionality. As we've talked about prior to today, being able to disclose our selected partner for this program, we certainly looked at a variety of different structures and options. Fortunately, we are in a position where those were possibilities and opportunities, including co-promotion opportunities. However, as we've also said several times, we tried to be disciplined and look at each product on its individual basis and merits and really be very, very focused on the best way to ensure that the product has access to the most women as quickly as possible. Because what that does is it maximizes access that's good socially, good for women, it's also good financially, and it can also impact your time to peak sales. So we looked at it from that perspective. Clearly, partnering with one of the premier companies in women's health, as we believe Organon is, with their commercial capabilities will ensure that XACIATO reaches the most impacted women from this condition as quickly as possible. While we'd love to think that Dare can add a lot of value commercially, it's clear that an organization like Organon, with their global footprint and strong commitment to women's health, aligned with what our mission is, is a great partner for this program. This allows Dare to continue innovating. Regarding your question about the transaction, which includes an opportunity for Organon to have exclusive worldwide rights and first negotiation for specified potential future Dare products, this represents the kind of work that Dare does. Organon's commitment to the category, our commitment to continuing to enhance and build our portfolio again with products that address persistent unmet need that have a potential to be first line or first in category products and have the potential to address and be meaningful commercial opportunities. That represents our alignment and vision regarding the future products.

Thanks, Sabrina. And then I just have two quick ones, and I'll get back in the queue. The first one here is just about the broad reach of Organon. I imagine that the XACIATO opportunity is important. So I wanted to get some commentary around what that market opportunity could be since it's primarily been talking about the U.S. market, and then how quickly could that be leveraged in terms of the market?

Yes, definitely. Obviously, they are a global organization, so they have that global footprint. In terms of the focus right now, we have the U.S. approval, so that is clearly a focus, and I think growth outside of the U.S. is an ongoing consideration. There's no confirmed plans that we're going to talk about right now, but obviously it is a global transaction. Women around the world experience Bacterial Vaginosis; it's not focused in the U.S., but the current approval today is in the United States. So that is a clear priority right now.

Thanks, good for modeling. And then the last here is just about some clarification for Ovaprene. I know after the IDE is removed, you can move into a Phase III study, but I was just wondering if there is anything that we need to know that can take place between the IDE approval and when you can start the Phase III just so we can guesstimate when that Phase III for Ovaprene can get underway.

Yes, that's a great question, and I'll try to provide as much clarity as I can. But basically, as I mentioned, we have initiated the IDE process with the FDA, which really allows us to have that collaborative discussion around the IDE and the clearance of the IDE. Importantly, one of the reasons we started that process is so that we can ensure we are aligned on the protocol for the pivotal study. One of the longest lead time items when preparing for a trial of any kind is that pivotal study protocol and design. Since Ovaprene is unique as a candidate in the contraceptive category—it's the first product that has the potential to be the first monthly hormone-free vaginal contraceptive method—having an understanding of some of those requirements is one of the important steps because there is work we have to do along with the NIH to prepare for that pivotal study so that we can initiate this year. By starting those discussions with the FDA, we have an understanding of some key pivotal study requirements (200 women completing 12 months). That significantly aids us in planning the manufacturing process, product supply to support the study, site selection, and other related activities. From an FDA perspective, we are focused on completing the IDE process. As we have updates on that, we'll provide them. We are really working toward this big picture, and we've got great clarification on the protocol which allows us to start planning activities.

Thanks, and congrats again on the partnership.

Thank you, thank you so much.

Thank you. And our next question comes from Douglas Tsao with H.C. Wainwright. Your line is open.

Thanks for taking the questions, and congrats on the deal. Just as a starting point, Sabrina, you've obviously successfully partnered XACIATO as well as Ovaprene, two of the premier women's health organizations in the world. I'm curious how you're now thinking about the pipeline and at what point is it right for you to become a commercial organization and begin to build out that capability.

Thank you for your question. First of all, thank you for recognizing what we've achieved to date in partnering with organizations like Bayer and Organon that have prioritized women's health. It's important to us to partner with organizations that truly align with our goals. When we partner for commercialization, we seek organizations that are aligned and have capabilities, as John mentioned, around access and commercial sales infrastructure to ensure that women impacted most by the conditions are served. So that's critical. Looking at commercialization strategy, we always want to do the best thing for the product. To your question about when it may become interesting for Dare to participate commercially, we have a portfolio of women's health products. I noted we have seven other programs in development, and I only discussed a few today. At what point might it become interesting for Dare to get involved? If we have various products that start to have approvals aligned from a timing perspective, we wouldn't want to be in a position with one product trying to build all infrastructure around it. It's more appealing when multiple products start to align. If we continue to deliver the way we have to date on these key two programs, developing products that address persistent unmet needs, that have first-in-category opportunities and commercial potential, we'll have real options, where we can partner if it makes sense or participate at some level in commercialization. If we decide to participate, it will be because we believe we can add value to the brand and our shareholders by doing so. You build value by ensuring that products reach the women who need them quickly and effectively. So our collaboration with organizations like Bayer and Organon, which have shown success in building significant and commercially successful brands in women's health, is key.

That's really helpful. And just a quick follow-up on the XACIATO deal with Organon specifically; just it's a global deal. Are any of the milestone payments tied to ex-U.S. commercialization?

Great question. What we've disclosed about the transaction is the overview, including the $10 million upfront consideration and the $2.5 million at first commercial sale. This also includes $180 million in additional milestone payments, which consist of tiered commercial sales milestones and regulatory milestones.

Okay. Great. Thank you very much.

Thank you.

Thank you. And our next question comes from Kumar Raja with Brookline Capital. Your line is open.

Thanks for taking my questions, and I will also add my congratulations for the partnership. Regarding drug supply, in terms of manufacturing, how is it going to work? Is Organon going to take over all of that?

Yeah, great question. As we guided previously, we are in the supply chain. Regarding supply, we have guided that because of our supply chain, the earliest that commercial supply is anticipated to be available is summer of this year; this ties into the anticipated timing around the commercial launch, which we expect in the fourth quarter. In terms of who is responsible, we will oversee regulatory interactions and provide that product supply on an interim basis until Organon assumes those responsibilities. Until that time, they'll purchase all product supply from us, and we will oversee manufacturing activity. We've been preparing for launch and supporting the clinical supply for the successful Phase III study.

So, I assume that would be a markup compared to whatever it's going to cost you guys?

Yes. There will be a transfer price which will equal our manufacturing costs plus a single-digit percentage markup.

Okay. And is there a timeline when it will switch completely to Organon?

Yes, that's not something we're discussing yet, but that is the intent that over time, those responsibilities will be taken over by them when it makes sense. We are all working toward a launch opportunity this year, which makes this an efficient way to get there.

Okay. And regarding Ovaprene, you touched on it a little bit regarding the IDE. Where are you in the process with the interactions? Can you share anything additional, especially on how long it will take to get clearance?

Really no more color than what I've shared to date other than we started that process at the beginning of this year with the IDE submission, which we converted to a pre-submission. This allows for a collaborative discussion around critical items such as the pivotal protocol, which was key since Ovaprene is so different from other contraceptive products. We wanted to ensure we received significant commercialization insights from Bayer before the pivotal study, so we could position it best for success. The IDE process allows us to engage interactively with the FDA while considering feedback. I'm unable to give you an end date right now, but our goal is to get underway with that pivotal study this year.

Yes, that's very helpful. So basically the understanding is it's going to be a seamless process once the pre-submission is gone and upon accomplishment; they have about 30 days, that duration is okay?

Thank you. Yes, that's correct.

Thanks so much. Congratulations again.

Thank you.

Thank you. And I am showing no further questions in the queue. I would like to turn the call back to Sabrina for closing remarks.

Great. Thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to really drive value for all of our stakeholders; women, healthcare providers, and our shareholders. In closing, 2021 was a year of very meaningful developments for Dare and positioned us well for this strong first quarter in 2022. We look forward to keeping you updated on our progress against important 2022 objectives and milestones, including activities over the next several months with Organon regarding XACIATO, preparations for the Ovaprene Phase III study with NIH and Bayer, and our ongoing Sildenafil Cream Phase 2b study for Female Sexual Arousal Disorder. Thank you all so much for taking the time. Thank you for supporting our work, and thank you for being aligned with our commitment to drive value for all of our stakeholders.

This concludes today's conference call. Thank you for participating. You may now disconnect.