Daré Bioscience FY2025 Earnings Call - DARE to PLAY pre-fulfillment live nationwide, revenue expected Q2 2026
Summary
Daré presented a clear, execution-focused year end 2025 update, pivoting from R&D heavy years into commercial activation. The headline is DARE to PLAY, a GMP-made topical sildenafil cream backed by published clinical data, which went live for pre-fulfillment prescriptions across all 50 states and via telehealth in February 2026. Dispensing is expected to begin in the coming months as the 503B outsourcing facility completes state licensing, with product revenue targeted to start in Q2 2026. The company is executing a dual path playbook, using 503B compounding to build real-world prescribing data and clinician relationships while pursuing a 505(b)(2) NDA for long-term market protection.
Beneath the DARE to PLAY launch sits a deep, grant-funded pipeline. Flora Sync LF5, a vaginal probiotic consumer product, and DARE-HPV, an ARPA-H funded investigational therapy with an IND cleared in February 2026, are moving forward. Ovaprene, a non-hormonal monthly contraceptive in phase III, expects enrollment completion in 2026 with a possible 2027 data readout. Financially, Daré ended 2025 with $24.7 million cash and working capital of $3.4 million, materially supplemented by non-dilutive grants. The company stresses capital efficiency via grant funding, but near-term revenue execution and channel economics will determine whether the story re-rates materially.
Key Takeaways
- DARE to PLAY, a topical sildenafil cream with published clinical data showing increased genital blood flow within 10-15 minutes, went live for pre-fulfillment prescriptions in all 50 states as of February 11, 2026.
- Telehealth access for DARE to PLAY launched alongside pre-fulfillment, enabling remote prescribing; dispensing will begin once the 503B outsourcing facility completes state licensing and fulfillment preparations.
- Daré is using a dual path commercial strategy: immediate 503B compounding to generate prescriptions and real-world data, while simultaneously pursuing a 505(b)(2) NDA for the sildenafil cream.
- Company claim: DARE to PLAY is the only sildenafil topical cream manufactured to GMP and backed by clinical data specifically in women, a core marketing differentiator versus untested compounded creams.
- Management expects product revenue from DARE to PLAY to begin in Q2 2026, with Flora Sync LF5 consumer probiotic revenue also targeted to start in Q2 2026.
- Flora Sync LF5, a vaginal probiotic developed with Probiotical and studied in a 100-person trial with peer-reviewed publication, is expected to be commercially available in the U.S. in Q2 2026 as a DARE to RESTORE consumer product.
- Ovaprene, a non-hormonal monthly intravaginal contraceptive in a pivotal phase III trial, has DSMB affirmation to continue enrollment and management expects enrollment to complete in 2026, positioning a 2027 data readout and potential PMA pathway.
- DARE-HPV received IND clearance in February 2026 and is preparing to enter a phase II study later in 2026, development funded in part by an ARPA-H award, aiming to be the first pharmacologic therapy for persistent high-risk HPV.
- DARE to RECLAIM, a monthly intravaginal ring delivering bioidentical estradiol and progesterone, is targeted for 503B availability in 2027, with IND-preparatory activities underway toward a potential phase III program.
- Daré emphasizes its pipeline breadth, asserting it may be the most robust development-stage, exclusively women’s health portfolio globally, with multiple grant-funded early programs focused on contraception and preterm birth prevention.
- Financial position at year-end 2025: $24.7 million cash and cash equivalents, working capital approximately $3.4 million; company also raised about $20.8 million net from ATM and equity line activity in 2025.
- Non-dilutive funding materially supplements R&D: approximately $13.6 million from the Gates Foundation, $4.5 million ARPA-H award, and $1.3 million NIH reimbursements in 2025; contra-R&D recognized was $13.9 million.
- Reported 2025 P&L highlights: SG&A $8.8 million (down from $9.2 million in 2024), reported R&D $5.5 million (down from $14.3 million in 2024), but reported R&D is offset by significant contra-R&D grant recognition.
- Commercial playbook is digitally native, centered on the DARE Health Hub, targeted digital marketing, telehealth partnerships and Medvantx as fulfillment partner, with provider-to-provider education used to build clinician adoption.
- Key operational risks and focus areas called out by management: need to convert pre-fulfillment prescriptions into dispensing and revenue as the 503B partner completes licensing, clarify patient acquisition economics across channels, and fend off commoditization by compounded alternatives by educating on formulation and time-to-effect.
Full Transcript
Operator: Welcome to the conference call hosted by Daré Bioscience to review the company’s 2025 financial results and provide a business update. This call is being recorded. My name is Desiree, and 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, Daré Bioscience: 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 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 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 bulk drug substances on the FDA’s interim Category One list. I will now turn it over to Sabrina.
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Thank you, Mardi. Good afternoon, everyone, and 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 that pairs 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 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, and 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 DARE to PLAY. Pre-fulfillment prescribing for DARE to PLAY sildenafil cream went live in February 2026 across all 50 states, and we’re just getting started.
DARE 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 genital blood flow in just 10-15 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, DARE to PLAY was designed to fill that void, and we’re making DARE to PLAY available as a Section 503B compounded product.
In December 2025, prescription intake commenced through the DARE Health Hub, powered by Medvantx Pharmacy, our fulfillment partner, initially in just a handful of states. That rapidly expanded. As of February 11, 2026, DARE 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 DARE to PLAY prescription, if it’s appropriate for them, without ever leaving their home. Prescribers are writing, women are engaging with telehealth, and 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 DARE Health Hub, working through the telehealth process, and providers are already submitting prescriptions. The market’s 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, but DARE to PLAY is the only formulation that’s backed by published clinical studies.
DARE to PLAY is the only product backed by clinical data in women, specifically formulated and demonstrated to increase genital 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 DARE 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, so they know exactly what they’re getting every single time. These are not baseless statements. They’re what the clinical data show and 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 Dare to Play through telehealth without an in-person office visit, a discreet and convenient option. Medvantx handles fulfillment and dispensing through the DARE 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 and how long they stay on the product, 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’s what else is what makes our approach uniquely powerful. While DARE 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, and 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 kind of strategic flexibility. It’s a direct result of how deliberately we designed our pipeline. DARE to PLAY is our most immediate new revenue story, so I wanted to start there because it’s happening. 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 DARE to RESTORE family. DARE to RESTORE products are probiotics designed to support vaginal microbiome balance. Our first DARE 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 is the exclusive manufacturer using their proprietary LF5 strain.
We believe that level of clinical evidence really distinguishes Flora Sync LF5 from the majority of vaginal probiotic suppositories on the market today, and we expect it to be an important differentiator. We intend to distribute DARE to RESTORE products through the DARE Health Hub. These vaginal probiotic products are intended to be complementary to our 503B prescription offerings. Healthcare providers may recommend DARE to RESTORE products alongside DARE to PLAY or other DARE products as part of a comprehensive approach to women’s vaginal and sexual health. We also expect to continue exploring opportunities to expand the DARE to RESTORE commercial offering through additional collaborations, including with Probiotical. DARE to RECLAIM is our proprietary monthly intravaginal ring designed to deliver bioidentical estradiol and progesterone, targeting the estimated $2.5 billion-$4.5 billion compounded hormone therapy market.
Women are demanding alternatives to synthetic hormones, and bioidentical hormone therapy is a category on the rise. DARE to RECLAIM is designed to be the first monthly intravaginal delivery solution in this space that includes both bioidentical estradiol and bioidentical progesterone together in one product. We’re targeting to have DARE to RECLAIM available for 503B prescription fulfillment in 2027, while simultaneously pursuing activities to support an IND filing for a pivotal phase III clinical study. Again, utilizing the dual path strategy of executing on both fronts at once. Imagine being the first monthly bioidentical hormone therapy intravaginal ring, including both estradiol and progesterone together in that estimated $2.5 billion-$4.5 billion market. That’s what DARE to RECLAIM is positioned to be, and investors can invest in that potential today. Now Ovaprene.
Ovaprene is our monthly intravaginal hormone-free contraceptive candidate, and 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, and 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 III pivotal trial right now. As you may recall, the Data Safety Monitoring Board reviewed interim data in July 2025, and 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 a 2027 data readout in reach. With it comes a 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 DARE-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, and if it doesn’t, the only recourse has been surgery once precancerous 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 2026, we are now preparing to advance DARE-HPV into a phase II clinical study later this year. DARE-HPV has the potential to be the first pharmaceutical therapeutic in one of the largest unaddressed infectious disease markets affecting women globally. Significant address, unaddressed market, grant-funded development, advancing into phase II.
That’s exactly the kind of asset that should get re-rated when investors discover it, and 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, DARE-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 DARE-PTB1, which is our bioidentical progesterone intravaginal ring candidate aiming to reduce the risk of preterm birth in at-risk women. Our pipeline is deliberately built to address the most persistent gaps, from preterm birth to HPV-associated disease to sexual health and beyond, and 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 options 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, and 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 healthcare 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, and revenue is on the near-term horizon. Women represent half the global population, yet women’s health receives just 6% of private healthcare investment. Conditions that solely affect women, the very conditions we’re developing treatments for, attract less than 1%. That’s not because it’s niche. That’s a market failure, and 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 DARE to RECLAIM enters the estimated $2.5 billion-$4.5 billion hormone therapy market, and before DARE-HPV data readout, the story is being written today. This is the catalysts, the catalyst stack that we’re targeting to deliver this year. DARE 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 DARE to PLAY to be announced as our channel infrastructure matures. DARE to RESTORE, Flora Sync LF5, advancing towards commercial availability in the U.S. consumer health market in the second quarter of 2026.
DARE to RECLAIM, targeting 503B commercial availability in 2027 with IND preparatory activities ongoing pursuant to our dual path strategy. Ovaprene phase III enrollment expected to complete this year, and as I mentioned, completing enrollment in 2026 puts a 2027 data readout within reach. DARE-HPV preparing to advance into phase II 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 DARE 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 that is difficult to replicate, establish relationships with telehealth providers, specialty pharmacies, and clinical KOLs in women’s sexual health and 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, DARE to PLAY, DARE to RESTORE, DARE 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, and 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, and we have been building our pipeline at low tide. Investors who want in before the water rises are looking at our company right now. With that context, I’ll turn it back over to Marty for the financial review.
MarDee Haring-Layton, Chief Accounting Officer, Daré Bioscience: 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 DARE 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, our actual total R&D investment when you add back contra-R&D amounts 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 DARE 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 DARE 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: Thank you, Marty. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via speakerphone in your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Again, press star one to join the queue. Our first question comes from the line of Catherine Novack with Jones Trading. Your line is open.
Leona, Analyst, Jones Trading: Hi, this is Leona on for Catherine. Thank you for taking our questions. 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 Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Thanks. Thanks for the question. Just a reminder to everyone. We did have interactions with the FDA last year, and 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 kind of interpersonal challenges should constitute part of that co-primary assessment and how specifically that’s going to be analyzed like, as it pertains to the statistical analysis plan and success. You know, we wanna 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 and providing and discussing together the various assessments that were included, not only in the phase II-B 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 erectile dysfunction because the clinical definitions are the same.
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.
Leona, Analyst, Jones Trading: Okay. Got it.
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: That dialogue is ongoing. Yeah. Thank you.
Leona, Analyst, Jones Trading: Okay. Do you need to conduct any additional safety studies, or will the submission rely on existing data for, like, systemic sildenafil in women?
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Yeah. The data we’ve collected from a safety perspective and what would be planned in the phase III would certainly be sufficient. I mean, 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 objective 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, you know, within that first 10-15 minutes of application, without really significant systemic uptake. In fact, we’re, you know, two orders of magnitude lower than what you would see with a comparable sort of 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, you know, not be supportive of the objective of the product in terms of enhancing arousal. But we just get that localized effect. We really did not see any difference in the phase II-B study, and the safety data are all published between the placebo group and the active group in terms of adverse event profile. Okay. Thank you so much. Yeah, thank you.
Operator: Our next question comes from the line of Kemp Dolliver with Brookline Capital Markets. Your line is open.
Kemp Dolliver, Analyst, Brookline Capital Markets: Thank you. What are you seeing with the order patterns so far for DARE to PLAY?
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Yeah, great question, and one, you know, we anticipated and are excited to get to talk about. You know 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 at 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.
They wanna make sure they get that prescription in for their patient, and they wanna 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. 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 kind of data to help us see that both channels are important, because this is a product that resonates with a healthcare provider.
It has the data, it has the peer-reviewed publications that they look to, and we don’t have to solely rely on, you know, a consumer channel and to see the breadth of both. More to follow on that as these convert to orders, as they start dispensing, and we will, you know, in the coming months be able to and start to provide more clarity, as I alluded to, in terms of, you know, that channel strategy, that approach, acquisition costs. Right now the focus has been on that very digital-focused campaign to make sure that consumers are aware of what’s available.
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, you know, published clinical data in their most trusted journals for products like this.
Kemp Dolliver, Analyst, Brookline Capital Markets: How are you thinking about promoting DARE to RESTORE, which really looks like, as you say in the press release?
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Yes.
Kemp Dolliver, Analyst, Brookline Capital Markets: It’s a consumer/OTC product.
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: 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. We’re gonna be able to leverage here some of the same channels that we’re leveraging for DARE to PLAY. It’ll certainly appear on the DARE Health Hub, which is where someone who’s getting a DARE to PLAY prescription will be going. It’ll 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 sort of strategy in terms of creating very focused and targeted strategy in the digital channels to create awareness and drive conversion through the DARE Health Hub and through the website. 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 finished 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, you know, they may be interested in obtaining products while they’re in that office visit, right, with that healthcare provider.
Those are other channels that we’re also looking at, very analogous to, you know, the derm space is very mature, right, in that regard in terms of the kind of products that are sometimes also available in your clinician’s office. For those clinicians where this becomes, you know, a very trusted solution for them, we see those channel opportunities as well.
Operator: Our next question comes from the line of Douglas Tsao with H.C. Wainwright. Your line is open.
Douglas Tsao, Analyst, H.C. Wainwright: Hi. Good afternoon. Thanks for taking the questions. Sabrina, I guess on DARE to PLAY, you know, 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 sort of platforms as well. I guess, how do you envision or what do you foresee as the bigger driver of volume ultimately? Will it be some of the different sort of telehealth and sort of subscription model platforms or do you see it being more driven by, you know, prescribers?
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Yeah. It’s a fantastic question, and 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 wanna 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? Kind of their reach and the number of touchpoints that they have.
What we wanna make sure that, you know, once dispensing commences in all 50 states, right, that we have all of those, you know, it’s available in all of the states, and we’ve 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 touchpoints for the product, but in a smart right, in a smart 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. It’s really coupling all those factors together, right? How many patients, right, how many touchpoints, 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? 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. You know, we wanna make sure that there’s financial stability, there’s solid alignment culturally and with the product fit, and that again, there’s a financially structured model that makes a lot of sense from a cost of acquisition perspective and reach for this product. Those are the things that we’ve been evaluating. You know, we wanna 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, you know, it’s available where women are going for their care.
Those are the factors that we’re looking at.
Douglas Tsao, Analyst, H.C. Wainwright: I guess as a follow-up question, I hear your point earlier in terms of you’re the only product that’s actually been tested. I guess it’s hard, you know, it’s like thinking about like, you know, so the GLP-1 class, right, where there are a lot of compounded products out there as well. You know, how do you necessarily. I think, you know, with your product, there are arguably more formulation differences that are arguably more important, right, to distinguish, you know, your product from other products that are out there.
You know, how are you able to or how are you thinking about being able to convey that message very broadly to sort of make sure that, you know, patients don’t try some of the alternative formulations and sort of give up on the, you know, sort of the topical sildenafil, and ultimately any sort of, you know, market share coalesces around your product? Thank you.
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Yeah. Absolutely. Fantastic question. You kinda hit the nail on the head in two. One, you know, On the one hand, the GLP-1 experience that people have had given people perhaps an impression that, you know, 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’ve found it’s very easy messaging with the consumer to explain that when you’re putting something on your skin, the formulation matters, right? We women have used a lot of different, you know, 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 it 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 the arousal sensations that the blood flow is gonna cause within 10 minutes. When a clinician or a consumer looks at any compounded sildenafil cream product that is not DARE 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.
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, and they understand it. With the consumer, it’s really about time to effect and that there are this has been engineered by Biotag specifically for them.
Douglas Tsao, Analyst, H.C. Wainwright: I guess as a follow-up, though, in terms of, you know, clinicians, I guess that sort of requires traditional, you know, sales promotion/detailing. With consumers, I guess it is some generally kind of mix through DTC advertising. Are you able to sort of defray some of that cost? ’Cause DTC can be expensive with some of the different sort of eHealth or partner, you know, sort of partnerships that you have in place to help with those costs.
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Yeah, absolutely. The other way to think about this, again, the world has really changed significantly in terms of. I’m gonna refer to the influencer space, and 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 kind of channels. Like, when we’re talking about enhancing our digital, you know, 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, DARE 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 product. We’re also very much leveraging, I would call it provider-to-provider, education and provider-to-provider, you know, promotion, marketing, for lack of a better word. Because we have credibility as a builder of solutions for the women that they serve and, you know, many of them have worked with us.
That’s not, you know, that’s not something that, you know, a compounder, for instance, is going to be able to do. It really resonates.
Douglas Tsao, Analyst, H.C. Wainwright: Okay, great. Thank you very much.
Sabrina Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: 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 Martucci Johnson, President and Chief Executive Officer, Daré Bioscience: Well, thank you. I definitely wanna close with something that I feel deeply, and it ties into some of the questions that we just went through, right? Women’s health has been dismissed, it’s been deprioritized, 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 was founded on the belief that women deserve better, and 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.
DARE to PLAY is entering the market, and as we just discussed, women are getting prescriptions and clinicians are engaging, and telehealth is live and is a great access path. The pipeline behind DARE to PLAY, it’s deep, it’s differentiated, and we’re finding ways to advance it. We built this company to really change how women experience healthcare, and that change is beginning in earnest now. 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, and we intend to execute on it. It’s 10 years of building, but the commercial inflection is here, and the pipeline is deep, and 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 who 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, and you may now disconnect.