Dare Bioscience Inc (DARE) 2025 Q4 法說會逐字稿

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  • Operator

  • Welcome to the conference call hosted by Daré Bioscience to review the company's 2025 financial results and to provide a business update. This call is being recorded. My name is Desiree. I will be your operator today.

  • With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer.

  • Ms. Haring-Layton, please proceed.

  • Mardee Haring-layton - Chief Accounting Officer

  • Good afternoon, and welcome to the Daré Bioscience financial results and business update call for the year ended December 31, 2025. Today, we will review our financial results, provide updates on our clinical pipeline, and discuss the continued execution of our expanded business strategy.

  • That strategy includes a dual-path approach, commercializing proprietary formulations through 503B compounding, while pursuing FDA approval and advancing select solutions as branded consumer health products that do not require a prescription. In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible.

  • I would 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 to known and unknown risks and uncertainties.

  • You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-K for the year ended December 31, 2025, which was filed today.

  • Please note that the content of this call includes time-sensitive information that is current only as of today, March 26, 2026. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

  • I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act, using both drug substances on the FDA's interim Category 1 list.

  • I will now turn it over to Sabrina.

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Thank you, MarDee. Good afternoon, everyone. Thank you for joining us. 10 years ago, we made a decision to focus exclusively on women's health, not as a sideline, not as a franchise within a broader portfolio, as our entire reason for existing. Every dollar raised, every clinical trial run, every regulatory submission prepared, every partnership negotiated, all of it for one purpose: building the company with the most comprehensive pipeline comprised exclusively of differentiated products for health issues and conditions that uniquely impact women.

  • From contraception to menopause, sexual health to fertility, vaginal health to infectious disease, we're working to close critical gaps in care with science that meets her needs. What distinguishes Daré is not just the breadth of the pipeline but the strategy behind it: a disciplined approach to capital allocation; the payers' non-dilutive grant funding, with focused development, moving multiple programs towards the clinic, simultaneously.

  • That's not a single product bet. That's a portfolio of strategy, built from the ground up, for one of the most chronically underfunded areas in all of medicine, despite affecting half the world's population. We're not a company that's just getting into women's health, we are a women's health company. 2026 is the year investors get to see what 10 years of that commitment actually looks like.

  • I want to take the next few minutes to share why we believe the investors who pay attention to the story, right now, will be glad they did. The best place to start that story -- because it's already happening in the market -- is DARÉ to PLAY.

  • Pre-fulfillment prescribing for DARÉ to PLAY Sildenafil Cream went live in February 2026 across all 50 states. We're just getting started. DARÉ to PLAY is a first-of-its-kind topical arousal cream for women.

  • To our knowledge, there is no other sildenafil topical cream manufactured under GMP requirements, with clinical data demonstrating increased general blood flow in just 10 to 15 minutes; and improvements in arousal, orgasm, and desire measured by clinically validated and FDA-reviewed endpoints.

  • Men have had Viagra in their medicine cabinet for over 25 years. Women have had nothing clinically studied and developed specifically for them until now. An estimated 20 million women in the United States alone report challenges related to genital arousal. There's not a single FDA-approved therapy that directly addresses this need; not one.

  • While there's not yet an FDA-approved therapy, DARÉ to PLAY was designed to fill that void. We're making DARÉ to PLAY available as a Section 503B-compounded product.

  • In December of 2025, prescription intake commenced through the DARÉ Health Hub, powered by Medvantx Pharmacy, our fulfillment partner, initially in just a handful of states. That rapidly expanded. As of February 11, 2026, DARÉ to PLAY is available for pre-fulfillment prescriptions in all 50 states.

  • Telehealth access launched, at the same time, so that women in most states can now receive a DARÉ to PLAY prescription, if it's appropriate for them, without ever leaving their home. Prescribers are writing. Women are engaging with telehealth. We expect dispensing to begin in the coming months, as the 503B outsourcing facility completes certain state licensing and other fulfillment preparations.

  • Women are finding their way to the DARÉ Health Hub, working through the telehealth process. Providers are already submitting prescriptions. The market is getting ready before we've even opened the commercial faucet.

  • You may be wondering why women would want to obtain a prescription for a product that isn't even being dispensed yet, when a pharmacy could compound a custom sildenafil cream for them, right now. That's the question we love because the answer is decisive: Every custom Rx pharmacy-compounded prescription sildenafil cream on the market may have been formulated to fill a prescription for women but not one of them was ever actually studied in women to evaluate whether or how it works in female physiology. They assumed it.

  • DARÉ to PLAY is the only formulation that's backed by published clinical studies. DARÉ to PLAY is the only product backed by clinical data in women, specifically formulated and demonstrated to increase general blood flow within just 10 minutes of application, studied for female response, and manufactured in accordance with FDA's current good manufacturing practice regulations, or GMP, and related product quality standards. That means consistent potency and quality guidelines that custom Rx prescription pharmacy or section 503A compounders simply cannot guarantee.

  • Healthcare providers and women tell us the same three things about DARÉ to PLAY that uniquely resonate with them: It works fast. It was genuinely built by biotech and studied for them. Following GMP potency and quality guidelines, they like that. They know exactly what they're getting every single time. These are not baseless statements. There was the clinical data show on what compliance with GMP requirements validates.

  • Our 503B commercial model is digitally native by design. We drive consumer awareness through targeted digital marketing. Women can access DARÉ to PLAY through telehealth without an in-person office visit, a discrete and convenient option.

  • Medvantx handles fulfillment and dispensing through the DARÉ Health Hub, with the quality infrastructure they already have in place. The daretoplaybio.com website is the conversion engine. The conferences we attend build healthcare provider credibility and patient community, simultaneously.

  • As we prove out what it costs us to acquire a patient digitally; how long they stay on the product; and, once dispensing commences in all 50 states, we can add channels and scale spend accordingly, layering in platform distribution partnerships from a position of leverage, not dependency. That's the playbook for a capital-efficient, strategically sequenced launch that we believe will maximize value for shareholders.

  • As our commercial footprint grows, we expect additional strategic partnerships with telehealth platforms, platform distributors, and clinical networks. Please stay tuned.

  • Here else is what makes our approach uniquely powerful: While DARÉ to PLAY is available for pre-fulfillment today through the 503B-compounding pathway, generating real prescribing data, building clinician relationships, and creating patient demand, we continue to simultaneously work to advance our sildenafil cream towards the 505(b)(2) NDA pathway for FDA approval, at the same time. That's the power of building our products around well-characterized chemical entities, compounds that have established safety databases.

  • It means we can start building a market for certain of our product candidates. We build that market while we are simultaneously building the regulatory file. The real-world data we generate through our 503B strategy may ultimately strengthen our NDA submission.

  • To our knowledge, there is no company of our size in women's health that has this strategic flexibility. It's a direct result of how deliberately we designed our pipeline. DARÉ to PLAY is the most immediate new revenue story. I wanted to start there because it's happening. But, now, let me step back and make a broader statement about what we've built because I believe most investors have not yet grasped the full scope of it.

  • To our knowledge, Daré Bioscience has the most robust development-stage pipeline of any company in the world, developing products exclusively for conditions that solely affect women. We have not been able to identify another company with a comparable portfolio.

  • Let me walk you through the most advanced programs in that portfolio: In addition to 503B-compounding, we're working to bring to market, in the United States, a line of consumer health products, branded as the DARÉ to RESTORE family.

  • DARÉ to RESTORE products are probiotics designed to support vaginal microbiome balance. Our first DARÉ to RESTORE product, Flora Sync LF5, a vaginal probiotic suppository developed by Probiotical, one of the world's leading probiotic research companies, is expected to become commercially available in the United States in the second quarter of 2026; this year.

  • The formulation is based on scientific research into the vaginal microbiome composition and health. It's been studied in a 100-person human clinical trial. Findings have been published in a peer-reviewed journal.

  • Probiotical uses the exclusive manufacturing, using their proprietary LF5 strain. We believe that level of clinical evidence really distinguishes Flora Sync LF5 from the majority of vaginal probiotic depositories on the market today. We expect it to be an important differentiator.

  • We intend to distribute DARÉ to RESTORE products through the DARÉ Health Hub. These vaginal probiotic products are intended to be complementary to our 503B prescription offerings. Healthcare providers may recommend DARÉ to RESTORE products alongside DARÉ to PLAY or other Daré products as part of a comprehensive approach to women's vaginal and sexual health.

  • We also expect to continue exploring opportunities to expand the DARÉ to RESTORE commercial offering through additional collaborations, including with Probiotical. DARÉ to RECLAIM is our proprietary monthly intravaginal ring designed to deliver bio-identical estradiol and progesterone, targeting the estimated $2.5 billion to $4.5 billion compounded hormone therapy market.

  • Women are demanding alternatives to synthetic hormones. Bio-identical hormone therapy is a category on the rise. DARÉ to RECLAIM is designed to be the first monthly intravaginal delivery solution in this space that includes both bio-identical estradiol and bio-identical progesterone, together, in one product.

  • We're targeting to have DARÉ to RECLAIM available for 503B prescription fulfillment in 2027, while simultaneously pursuing activities to support an IND filing for a pivotal Phase 3 clinical study; again, utilizing the dual-path strategy of executing on both fronts at once.

  • Imagine being the first monthly bio-identical hormone therapy, intravaginal ring, including both estradiol and progesterone, together, in that estimated $2.5 billion to $4.5 billion market. That's what DARÉ to RECLAIM is positioned to be. Investors can invest in that potential today.

  • Now, Ovaprene. Ovaprene is our monthly intravaginal hormone-free contraceptive candidate. It's among the programs that I believe carries some of the most extraordinary long-term value in our portfolio because the contraceptive market is large and it is shifting. A growing number of women -- particularly, younger women -- are actively seeking alternatives to hormonal contraception. They're demanding effective, convenient, non-implanted, non-hormonal options. That demand is real. It's growing.

  • The current market has nothing to offer beyond in-the-moment solutions like condoms or vaginal gels. Ovaprene is in a Phase 3 pivotal trial, right now. As you may recall, the Data and Safety Monitoring Board reviewed interim data in July of 2025. They recommended that the study continue; and that we continue enrollment without modification.

  • We are now happy to let you know that we currently anticipate enrollment to complete this year. Completing enrollment in 2026 puts the 2027 data read-out in reach. With it comes the potential PMA pathway for what could be the first non-implanted, non-hormonal monthly contraceptive option on the market. This asset alone in a world actively demanding non-hormonal contraception has partnership and licensing potential that we believe the market has dramatically undervalued.

  • Speaking of undervalued, I want to turn to DARÉ-HPV, which is perhaps our most underappreciated program, given its potential. Roughly 6 million women in the United States alone acquire a high-risk HPV infection every year. Today, every single one of them is being managed with watchful waiting or surgery. There is no drug therapy. That represents a completely untreated patient population, with a clear clinical need and no existing direct competition in the pharmacologic space.

  • High-risk HPV types are the underlying cause of virtually all cervical cancer cases in the United States; 99% of them. For decades, women with persistent high-risk HPV infection have been told to watch and wait; to monitor and hope that the virus clears on its own. If it doesn't, the only recourse has been surgery.

  • Once pre-cancerous changes appear, there's not a single FDA-approved pharmacologic treatment for high-risk HPV infection, not one. We're developing one with ARPA-H funding.

  • With FDA clearance of our IND application just this February of 2026, we are now preparing to advance DARÉ-HPV into a Phase 2 clinical study later this year. DARÉ-HPV has the potential to be the first pharmaceutical therapeutic in one of the largest unaddressed infectious disease markets affecting women, globally.

  • Significant unaddressed market, grant funded development, advancing into Phase 2, that's exactly the asset that should get re-rated when investors discover it. We believe very few have.

  • In addition to the portfolio programs that I just highlighted, other potential first-in-category contraceptive candidates currently supported entirely with grant funding -- DARÉ-LARC1, Casea S -- and activities will aid in the identification and development of a novel non-hormonal intravaginal contraceptive candidate suitable for and acceptable to women in low- and middle-income country settings, who need or would prefer to use such a product to avoid unplanned pregnancy. Those programs continue to advance with that 100% grant funding.

  • We also recently announced an extension of an NIH award for DARÉ-PTB1, which is our bio-identical progesterone intravaginal ring candidate aiming to reduce the risk of pre-term birth in at-risk women. Our pipeline is deliberately built to address the most persistent gaps, from pre-term birth to HPV, associated disease to sexual health and beyond. Where we can use strategic non-dilutive funding, like the foundation and NIH grants I mentioned; and ARPA-H grants to advance that work, we will.

  • Every dollar of grant funding we secure is a dollar that moves us closer to putting better option in women's hands, without diluting our shareholders.

  • I want to speak directly to every investor on this call -- institutional, retail, and everyone who listens to the replay -- we spent 10 years building this. We did it the right way, with clinical rigor, disciplined capital management, and with an unwavering commitment to women who have been underserved by the health care system for far too long.

  • Right now, in early 2026, we're at the moment where all of that investment converges into action. Products are coming live. Demand is building. Data is forthcoming. We're poised for partnership. Revenue is on the near-term horizon.

  • Women represent half the global population yet women's health received just 6% of private healthcare investments. Conditions that solely affect women, the very conditions we're developing treatments for, attract less than 1%. That's not because it's a niche. That's a market failure. It is exactly the gap that Daré was built to address.

  • The investors who will look back and say they saw this coming are the ones paying attention, right now. Before the prescriptions become revenue, before the Ovaprene data reads out, before DARÉ to RECLAIM enters the estimated $2.5 billion to $4.5 billion hormone therapy market, and before DARÉ-HPV data read-out, the story is being written today. This is the catalyst stack that we're targeting to deliver this year.

  • DARÉ to PLAY dispensing, scaling nationally in the coming months, with revenue expected to begin in the second quarter of this year. Additional commercial and telehealth partnerships for DARÉ to PLAY, to be announced, as our channel infrastructure matures.

  • DARÉ to RESTORE, Flora Sync LF5, advancing towards commercial availability in the US consumer health market in the second quarter of 2026. DARÉ to RECLAIM, targeting 503B commercial availability in 2027, with IND preparatory activities ongoing, pursuant to our dual-path strategy.

  • Ovaprene Phase 3 enrollment, expected to complete this year. As I mentioned, completing enrollment in 2026 puts the 2027 data read-out within reach. DARÉ-HPV, preparing to advance into Phase 2 this year, with our ARPA-H funding. This is not a single-event binary bet. It's a portfolio with multiple catalysts, multiple pathways to value, and multiple ways to win.

  • Here's what I want you to understand about our competitive position: We believe we're positioned for advantages that compound, over time. With every prescription written for DARÉ to PLAY, we build the real-world data set that strengthens our NDA submission. Every Ovaprene patient enrolled moves us closer to data that will attract partners. Every clinician who prescribes one of our products becomes an advocate for the next.

  • We're not starting over with each product. We're building a platform on years of clinical data -- data that is difficult to replicate; establish relationships with telehealth providers, specialty pharmacies, and clinical KOLs and women's sexual health, vaginal health, and beyond; groundwork laid for the 505(b)(2) regulatory pathway that we believe provides an opportunity to protect and expand our market positions after the 503B market matures; brands DARÉ to PLAY, DARÉ to RESTORE, DARÉ to RECLAIM built around clear resonant identity with women.

  • We're operating at a moment when the culture and commercial conversation about women's health has never been louder. The femtech and the services sectors are attracting serious capital. Women are demanding that healthcare take their needs seriously. Payers and providers are beginning to respond. Political and media attention on women's health, including contraception, sexual health, and menopause is at historic highs.

  • Daré Bioscience is not trying to ride that wave. We were building for it for a decade before it arrived. Our pipeline is not reactive to a trend. It foresaw the trend and exactly is what the trend is calling for. The tide's rising in women's health. We have been building our pipeline at low tide, to investors who want to end before the water rises are looking at our company right now.

  • With that context, I'll turn it back over to MarDee for the financial review.

  • Mardee Haring-layton - Chief Accounting Officer

  • Thanks, Sabrina. Good afternoon, everyone. I will now walk through our financial results for the full year ended December 31, 2025; and provide context on our balance sheet and forward financial positioning.

  • We ended the year with approximately $24.7 million in cash and cash equivalents; and working capital of approximately $3.4 million. During 2025, we received approximately $20.8 million in net proceeds from sales of common stock under our ATM facility and equity line agreement.

  • Additionally, we received non-dilutive capital that contributed to strengthening our balance sheet in 2025, including approximately $13.6 million received from the Gates Foundation, $4.5 million received under an ARPA-H award, and $1.3 million received from NIH grant reimbursements. Together, these sources allowed us to advance multiple programs simultaneously, while managing shareholder dilution responsibly.

  • Selling, general, and administrative, or SG&A, expenses for the full year were $8.8 million compared to $9.2 million in 2024. The year-over-year change was primarily driven by decreases in stock-based compensation expense, personnel costs, and general corporate overhead expenses. Such decreases were partially offset by increased commercial readiness expenses -- primarily for DARÉ to PLAY -- and increased professional services expenses.

  • Research and development, or R&D, expenses were $5.5 million for the full year compared to $14.3 million in 2024. I want to highlight an important feature of our R&D expense reporting: We recognize non-dilutive funding awards as contra-R&D expense; meaning, grant funding directly offsets our reported R&D costs on our income statement. In practical terms, this means we are investing more in R&D than our reported R&D expense line suggests.

  • Contra-R&D expense, reflecting grant dollars received was $13.9 million in 2025 compared to $7.7 million in 2024. In other words, while reported R&D expenses declined year over year, are actual total R&D investment, when you add back contra-R&D amount, was much closer between 2025 and 2024 than the R&D expense line alone reflects.

  • We believe this is an important dynamic for investors to understand when evaluating our capital efficiency, with the use of grant funding and the true scale of our R&D investment.

  • We expect to begin recording product revenue from DARÉ to PLAY in Q2 2026, as dispensing commences nationally. Flora Sync LF5 consumer health revenue is also expected to begin in Q2 2026. We are targeting to begin recording revenue from DARÉ to RECLAIM in 2027. We are building toward a multi-product revenue profile that diversifies and grows across 2026 and 2027.

  • We encourage investors to review the more detailed discussion of our financial statements, financial condition, liquidity, capital resources, and risk factors in our Form 10-K for the year ended December 31, 2025, filed today.

  • Operator, please open the line for questions.

  • Operator

  • (Operator Instructions)

  • Catherine Novack, JonesTrading.

  • Leona Nease, PhD - Analyst

  • This is Leona, on for Catherine. When was your last interaction with FDA on sildenafil cream? What are the next steps for clinical development in the 505(b)(2) regulatory path? I'll ask a follow-up after.

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Thanks for the question. Just a reminder of everyone: We did have interactions with the FDA last year. Really, at this point, what we are looking at with that program is making sure that we're 100% aligned on the endpoints -- the primary endpoint -- for the trial and not so much the arousal part -- our arousal questions are really clear and straightforward -- but what else in terms of any interpersonal challenges should constitute part of that co-primary assessment and how specifically that's going to be analyzed for part of the statistical -- like, as it pertains to the statistical analysis plan and success.

  • We want to make sure that we're very clearly aligned on that. Our interactions with the FDA -- particularly, the last set of interactions in 2025 -- were really to make sure that we were sharing, providing, and discussing together the various assessments that were included, not only in the Phase 2b study but, also, the work we had done prior to that in the content validity study, which really is a study that helps you ascertain what questions are content-valid and fit as patient-reported outcomes to make sure that we're all thinking together about a full picture of what makes sense for this particular indication, which is really focused on improvement of genital sensations of arousal; very analogous -- couldn't be more analogous to a erectile dysfunction because the clinical definitions are the same.

  • And so we're working closely with the FDA to make sure that there are endpoint frameworks that are reflective of the similarity between the conditions and the unmet needs. That dialogue is ongoing.

  • Leona Nease, PhD - Analyst

  • Okay. And then, do you need to conduct any additional safety studies? Or will the submission rely on existing data for, like, systemic sildenafil in women?

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Yeah. The data we've collected from a safety perspective and what would be planned in the Phase 3 would certainly be sufficient.

  • One of the things that has been, I would say, fantastic about being able to formulate a product like this into a topical formulation that achieves the blood flow objectives that we want is that it's really been designed to target those tissue and get that very rapid increase in temperature that we've seen quantitatively in the published study within that first 10 to 15 minutes of application, without really significant systemic uptick.

  • In fact, we're two orders of magnitude lower than what you would see with a comparable oral dose, as seen in the male studies. That's really been the objective -- is to make sure that we keep that systemic exposure very low so we don't get those off-target effects of headache and flushing. That would not be supportive of the objective of the product in terms of enhancing arousal. But we just get that localized effect.

  • And so we really did not see any difference in the Phase 2b study. The safety data are all published between the placebo group and the active group in terms of adverse event profile.

  • Operator

  • Kemp Dolliver, Brookline Capital Markets.

  • Kemp Dolliver - Analyst

  • What are you seeing with the order patterns, so far, for DARÉ to PLAY?

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Yeah. Great question, one we anticipated and they're excited to get to talk about. What's been exciting about it, I would say, is that we're in this pre-fulfillment phase for the product, while our 503B collaborator continues certain activities. Prescriptions are coming in. But they're not being dispensed yet.

  • What has been exciting about it is that we're seeing a mix of prescriptions coming in from brick-and-mortar providers, right? People that we have been engaging with the conferences, who have gotten to know the product, and are excited to write it for their patients when they see their patients, even though it's not dispensing yet.

  • But they want to make sure they get that prescription in for their patient and they want to make sure that they are letting their patient know, right, that there's a solution like this that is going to be available for them that actually has clinical data; has published peer-reviewed findings; as well as women engaging with telehealth.

  • We're really seeing that both of those channels are active and relevant. And so that's been really helpful for us to understand. Particularly, early in this awareness and education campaign, it's been very nice to be able to have these data to help us see that both channels are important because this is a product that resonates with the healthcare provider.

  • It has the data. It has the peer-reviewed publications that they look to. We don't have to solely rely on a consumer channel to see the breadth of both. More to follow on that, as these convert to orders, as they start dispensing. We will, in the coming months, be able to and start to provide more clarity, as I alluded to, in terms of that channel strategy, that approach, the acquisition costs.

  • But, right now, the focus has been on that very digital-focused campaign to make sure that consumers are aware of what's available. But, also, we've really been attending the conferences and doing the provider-to-provider education that is very relevant for a product like this that has published clinical data in their most trusted journals for products like this.

  • Kemp Dolliver - Analyst

  • How are you thinking about promoting DARÉ to RESTORE, which really looks -- as you say in the press release, it's a consumer/OTC product?

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Great. Another great question. You really hit something important, which is, it does not require a prescription, right? These are products that consumers -- these types of products are something that a consumer is a little more familiar with.

  • I will say it's also in a category of products that a number of consumers do also engage with their healthcare provider to understand what their healthcare provider recommends. And so we're going to be able to leverage here some of the same channels that we're leveraging for DARÉ to PLAY.

  • It will certainly appear on the DARÉ Health Hub, which is where someone who's getting a DARÉ to PLAY prescription will be going. It will appear right there as something that can also be purchased, at the same time.

  • We will also be similarly engaging in a very digital-native strategy in terms of creating very focused and targeted strategy in the digital channel to create awareness and drive conversion through the DARÉ Health Hub and through the website.

  • But, also, we will be participating in medical conferences and showcasing this product at those conferences because it is very distinct in the fact that there are peer-reviewed published data on both the strain itself and on the final-finish formulation. We think that's something that healthcare providers will be very interested in.

  • There is a whole category of healthcare providers that are starting to recognize that, for some women, they may be interested in obtaining products while they're in that office visit, right, with that healthcare provider. And so those are other channels that we're also looking at; very analogous to the derm space that's very mature, right, in that regard, in terms of the products that are sometimes also available in your clinician's office.

  • And so for those clinicians, where this becomes a very trusted solution for them, we see those channel opportunities, as well.

  • Operator

  • Douglas Tsao, HC Wainwright.

  • Douglas Tsao - Equity Analyst

  • Sabrina, on DARÉ to PLAY, it sounds like you're doing a lot of work in terms of physician education. I know you've also done some work with different online platforms, as well. How do you envision or what you could see as the bigger driver of volume, ultimately? Will it be some of the different telehealth and subscription model platforms? Or do you see it being more driven by prescribers?

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Yeah. It's a fantastic question. It's something that we have been looking at very closely and monitoring very closely.

  • As I noted in the comments, one of the things that we want to make sure that we understand very clearly, as we look at these various platforms, is making sure that we understand in the channels that we have available to us, today as well as what those conversations look like, right, with those other telehealth providers and platforms, what the patient acquisition cost -- customer acquisition cost -- is in those various scenarios, paired with their reach, right, in there and the number of touch points that they have.

  • What we want to make sure that, once dispensing commences in all 50 states, right, we have all of those -- it's available in all of the states. We have been collecting all of these data; that we're making sure that we're layering in these partnerships with a financial structure that makes sense to extend the reach and the touch points for the product. But in a smart, righ, structure that takes into consideration the various acquisition costs in the channels that we have been in already, as well as the reach in those channels.

  • And so it's really coupling all those factors together, right? How many patients, right? How many touch points? How many users do they already have on a particular platform, right? What is that relationship going to look like with them to access those people? Where do the cultures align and this product fit nicely there? I feel like there's a new telehealth platform stood up every day.

  • Practically, for women's health, right now, because it's become a very hot area. We want to make sure that there is financial stability. There's solid alignment, culturally, with the product fit. And then, again, there's a financial structured model that makes a lot of sense, from a cost of acquisition perspective; and reach for this product. And so those are the things that we've been evaluating.

  • We want to make sure that the product is available in all of the channels that make a lot of sense, both in terms of reach and demand; and to make sure it's available where women are going for their care. Those are the factors that we're looking at.

  • Douglas Tsao - Equity Analyst

  • As a follow-up question -- and I hear your point earlier in terms of -- you're the only product that's actually been tested. It's hard. It's thinking about the GLP-1 class, right, where they have a lot of compounded products out there, as well.

  • How do you necessarily -- but, I think, with your product, there are arguably more formulation differences that are arguably more important, right, to distinguish your product from other products that are out there?

  • How are you able to -- or how are you thinking about being able to convey that message very broadly to make sure that patients don't try some of the alternative formulations and give up on the topical sildenafil and, ultimately, market share coalesces around your product?

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Yeah. Absolutely fantastic question. You hit the nail on the head in two: One, on the one hand, the GLP-1 experience that people have had have given people perhaps an impression that you can go anywhere, right, and get the same product. But, of course, there are already initiatives underway in that category to educate around that and make sure it's aware.

  • But you also touched on something super important with regard to this formulation, which has been very compelling to people. It's very easy, both for healthcare providers -- and we found it's very easy messaging with the consumer -- to explain that, when you're putting something on your skin, the formulation matters, right?

  • Women have used a lot of different topical products. We use face creams every day. We use whatever, right? Being able to explain that what is key here is that this is a very important medicine that needs to get into the skin and that you can't just mix something together and do that.

  • What really resonates more than that statement is the fact that we have clinical data demonstrating increase in blood flow, which is basically a surrogate for, right, the arousal sensations that the blood flow is going to cause within 10 minutes.

  • When a clinician or a consumer looks at any compounded sildenafil cream product that is not DARÉ to PLAY with our [DermaFlux] technology inside of it to drive that sildenafil into the tissue, they all talk about, put it on at least 30 minutes before or longer because they don't have the data. That time factor resonates more than anything.

  • And so with a healthcare provider, we're able to get into that more complex conversation with them around the clinical work that's been done; and the formulation technology and why that matters. That resonates very clearly with them. They understand it. With the consumer, it's really about time to effect and that this has been engineered by biotech specifically for them.

  • Douglas Tsao - Equity Analyst

  • As a follow-up, though, in terms of clinicians, that requires traditional sales promotion/detailing? With consumers, it is some -- generally mixed through DTC advertising? Are you able to defray some of that cost because DTC can be expensive with some of the different e-health or partnerships that you have in place to help with those costs?

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Yeah. Absolutely. The other way to think about this, again, the world has really changed significantly in terms of -- and I'm going to refer to the influencer space. I don't mean influencers who have, I don't know, no knowledge of clinical science or medical science. But I'm talking about healthcare providers who have very significant followings because they have been educators and are sharing knowledge in an area that women are very desperate and hungry to get information around.

  • These are the channels. Like, when we're talking about enhancing our digital -- our focus around education, these are a lot of the channels that you'll be seeing more and more, right, as this product starts dispensing, that are getting utilized because these are trusted clinicians, trusted voices, that are looking for brands, products solutions that they can get behind.

  • I think the other thing to really highlight -- and we have seen this at every conference that we've been to -- DARÉ to PLAY is one product but Daré Bioscience is a brand in and of itself, right? We've run so many clinical trials, so many healthcare providers have worked with us on one of our studies, right? They are proudly telling their friends, their peers about the products.

  • We're also very much leveraging, I would call it, provider-to-provider education and provider-to-provider promotion, marketing, for lack of a better word, because we have credibility as a builder of solutions for the women that they serve. Many of them have worked with us. That's not something that a compounder, for instance, is going to be able to do. It really resonates.

  • Douglas Tsao - Equity Analyst

  • Okay. Great. Thank you very much.

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Yeah. Absolutely.

  • Operator

  • That concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for closing remarks.

  • Sabrina Johnson - President, Chief Executive Officer, Secretary, Director

  • Well, thank you. I definitely want to close to something that I feel deeply. It ties into some of the questions that we just went through, right? Women's health has been dismissed. It's been de-prioritized. It's been underfunded for generations. The conditions that we address at Daré Bioscience, from arousal, vaginal health, menopause, contraception, HPV, these are conditions that affect millions of women worldwide, right?

  • They're not rare. They're common experiences that have been met far too often with inadequate options, clinical dismissal, lack of data, or simply nothing at all. Daré Bioscience is founded on the belief that women deserve better. That belief has guided every decision we have made. I started Daré because I believe women's health was both a moral imperative but, also, a compelling strategic opportunity.

  • 10 years in, I believe that, more than ever, Daré to PLAY is entering the market. As we just discussed, women are getting prescriptions. Clinicians are engaging. Telehealth is live and is a great access path. The pipeline behind DARÉ to PLAY, it's deep. It's differentiated. We're finding ways to advance it. We built this company to really change how women experience healthcare. That change is beginning in earnest now.

  • And so, to our investors, thank you for your confidence and for being owners. We believe the assets we hold, the catalysts that I outlined that are coming up, and this window of time that we are in represent a compelling opportunity. We intend to execute on it.

  • It's 10 years of building. But the commercial inflection is here. The pipeline is deep. The market is ready. Daré Bioscience in 2026 is a story that is just beginning to be told. I think the investors who had conviction in the first chapter will be the ones you remember this call. I thank you all for participating today and look forward to more updates in 2026.

  • Operator

  • Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.