Daré Bioscience, Inc. (DARE) Earnings Call Transcript

Okay. We are ready to get started, and welcome, and thank you for joining us for the Daré Bioscience's, virtual Buswor. My name is Jenene Thomas. I am CEO of JTC IR, and I will be the moderator for today's event. We are excited to continue the virtual bus tour series with the Midwest stop. And for the format today, Sabrina Martucci Johnson. She is President and Chief Executive Officer of Daré Bioscience will take you through the Daré story. I will then open the event up for a Q&A and take your questions. So now it is my pleasure to turn it over to Sabrina.

Great. Thank you, Sam, and thank you for all those of you tuning in today. So before I get started, I definitely wanted to highlight that the presentation will contain forward-looking statements. And these factors about our business, so please do refer to our SEC filing for a full overview of the risks and uncertainties associated with our business. So for those of you who know us well, you may know that we're focused solely on advancing health for conditions that affect women. And it's a great time to really tune in and get to know us better because 2026 and 2027 and really 2 exciting years for us. So our portfolio is built solely on closing those therapeutic gaps in care using finance that serves her needs. And in 2026, as you'll hear, we have 2 products that are commercializing for women. So we're going to talk about those. As well as in 2027, we had 2 products that are going to have really important data readouts. And what you'll see as we go through the portfolio is across the portfolio, whether it's our commercial products, which we strive to make available via all paths that we can leverage to make sure that we're getting these evidence-based solutions in the hands of women -- so whether we're talking about a commercial products, and we're talking about development stage candidates, but everything has in common is that clinical and evidence basis to the solutions. The other thing you'll see, as I highlight the portfolio and our achievements and what we're doing on the research side is how we leverage grant funding to advance programs in our portfolio. Daré's portfolio is not built around a specific life stage or a specific product. Specifically, we're looking to, again, build those therapeutic gaps in care wherever they may exist. They are from contraception through to menopause, sexual health to fertility and infectious disease, we're closing those critical gaps in care using that science that serves their need. And as I go through the top today, I'm really going to focus on 6 of our programs. And these are programs that I'm going to highlight because they are the programs that are commercializing like Flora Sync LF5 5 and data plan identical cream -- or their programs that have clinical data readouts like our DRHV program and our Ovaprene contraceptive program or like Goodes on 2018 at ola.It's something that we're looking to commercialize next year or like our geared PTVI program, it's something that we're looking to get into a Phase I study supported by grant funding. But before I go into the portfolio in more detail, I really want to take a minute to talk about why woman's health and why now. We really love working in this category for a few important reasons apart from the important mission of our work. But from a value perspective, what we like about this category is really 3 important pillars that make it so exceptional. One is, despite the disproportionate lack of funding that has gone into women's health, where women's health only receives 1 to 5% of private health care investment. If you look at products that actually generate over $500 million in the annual revenue, 27% of those are in women's health. So it's been a disproportionately accretive category from that perspective. Second, women's health is interesting because so many of the areas where there are therapeutic gaps are not really diseases in a traditional sense, but these are things that women are likely to experience throughout their lifespan, whether it's thinking about contraception, going through a pregnancy or fertility, going through menopause, sexual health that can be impacted by hormonal shifts and life ships, -- so that makes it building compelling with those large categories that everyone is affected -- and then also because there hasn't been as much investment in the category over the years, and women weren't even required to be included in clinical research until 1993, there are a number of conditions that are quite serious that don't have any pharma ologic pharmaceutical solution. So think about high risk HPV infection. It's the virus that causes cervical cancer, 6 million women acquire that infection every single year, and yet there's no FDA-approved product to treat that infection. Then the third thing that we find so compelling about this category from a development and investment perspective is the amount of grant funding that's available. And we've really leveraged that across our portfolio and from different types of grant makers, whether it's the Gates Foundation or government agencies like Arca or NIH across our portfolio, including our late-stage programs, we've really leveraged that grant funding to advance our portfolio. And another highlight before I really get into the products is the white space we're filling. There's a lot of conversations happening about women's health, and that is fantastic that the medicine is not keeping up with the conversation. And many of the options that are available to remind today are just not built on finance, right? Their marketing language versus actual trials. And so what really distinguishes our products and us as a company is that it's a portfolio built on science. So all of our products go through clinical development. Our proprietary products are protected in terms of novel formulations and development and delivery technologies -- and then we're making sure that we then have access to them wherever they're getting their care and wherever they're seeking solutions. So whether they're going to a brick-and-mortar health care provider, they're participating in telehealth. They're searching for products online, -- we want to make sure that our products are directly available to them wherever they are. So let me dive right into that purpose-built portfolio. So first of all, I want to talk about Flora Sync LF5 because this is live and on the market now. This is a vaginal probiotic. So we might be -- have heard of probiotics in the context of Gut Health and the gut microbiome. -- but the vagina has the microbiome as well, and it can be very easily disrupted from antibiotics, whether activities we participate in hormonal shifts -- so a lot of things can disrupt that batch of microbiome. And when a microbiome individetial environment is disrupted, it can lead to things that women experience and will notice in terms of changes and changes in discharge changes odor, changes in comfort. And so a probiotic can really assist with that -- the vast majority of the probiotics that are available today for women are got strains for the stomach that are delivered orally. So those are not really optimized or delivered to the vaginal environment, and that's where Flora Sync LF5 really shines. This is a biotic that was specifically developed strain from winning their vagal microbiome who have never experienced last infection, and it's been clinically studied and back by over 30 years of research -- and in a 100% clinical study demonstrated that 96% of women achieved that for microbiobalance within just 3 days of onetime use each day in the product at that time and 90% maintain that balance 2 weeks out. So it's available now on the Daré Health Hub, it's $49 for the box and the box comes with 2 courses -- and that's really purposeful. This is something that we think women can incorporate into their vaginal wellness routine and really start to think about evangelwellness routine. It's available right now exclusively on the Daré Health Hub that we are actively looking at some other channels, including clinician offices as well as other retail channels for the product. So more on that to follow, Daré place NFL cream is a prescription product that is a first of its kind of reuse cream for one. It has been demonstrated to increased general blood flow within just 10 to 15 minutes of application. -- and to improve arousal sensations and that's been demonstrated using clinically validated and FDA reviewed endpoints. There's really nothing else out that's available on the market today that has been clinically studied and designed specifically to do this for women. We're making it available as a 503B compounded product. And what that means is it's manufactured at a feet facility, it's not yet FDA approved. -- but it's manufactured by the 3D facility that does register with the FDA was subject to FDA infection and is required to manufacture the product under the same quality manufacturing standards called good manufacturing practices that pharmaceutical products are required to be manufactured to -- and they are looking to make this product available later this quarter and start dispensing. And I say start dispensing because prescribers are already writing prescriptions and women are already going through telehealth, so that their prescriptions are in the queue so that as this product start dispensing, they can be the first to get this product was first of its kind of a reuse cream for women. And it's available. It comes in a tube. The tube is $99 and it has 10 doses in the tube. And it's just used on-demand perceptual event by women. So we're very excited to make this available this year. And I want to talk about something that really distinguishes are in terms of how we can leverage our commercialization strategy for these products because we're leveraging the clinical relationships that we built through product development -- there are not many companies innovating therapeutic prescription products in the women's health space, unfortunately. And so Daré has really stood out in that regard in our clinical development over the last 10 years. And we're really able to translate those clinical relationships into now, really a commercial advantage because those providers provide peer-to-peer education about our product, they become prescribers for our product as our portfolio continues to expand, it's even more opportunities for us to have that kind of level of provider engagement because these products really speak for themselves. And in terms though of, as we think about getting our products to market in that really unified women's help ecosystem, it takes those provider relationships as they're so critical -- but as I mentioned upfront, we want to make sure that wherever she's getting her information or her care, she's going to have access to our products. So in addition to health care providers that have clinical practices in office. It's also really important that we're working with health care providers with the telehealth infrastructure, right? That has national reach -- and those prescribers can become very important in terms of integrating new products like these into their recommendations and prescribing habits for the woman that they serve. We also want to make sure that we're really leaning into a digital native strategy. So a lot of people are getting their information online. And there's an opportunity for products like this that are clinically and evidence back solutions for us to work with really health care provider influencers. So think about influencers, can think about influencers that are clinicians that are health care providers that are institutions that put out information for consumers like the Menopause Foundation, those kind of organizations are great for us to really leverage as we work to get the word out about our products because they're trusted sources and information and they're looking for trusted products that they can talk about the people that follow them as well. And then in terms of where people can get the products, it's really important that we have a central patient destination that is designed for them and for fulfillment there. So that's our Daré Health Hub, -- and it's really our central commercial platform. So we work with Movantik pharmacy. They really support all the logistics on the back end -- and on the Daré Health Hub, women can get access to our prescription products as well as our nonprescription product. So Data crore for in they can link to get 1 information about the products. If they don't have a prescription, they can access telehealth, that is service through Avanti and it allows them to also get information across our products. And then on the back end, it's where prescribers can submit their prescriptions. Movantik is a central mail order pharmacy. They show up in most electronic record systems automatically. So it's really seamless. So for both the provider experience and the consumers' experience. I want to now highlight a few things that I mentioned up front from the development time line. So the first is Ovaprene. So Ovaprene is a first in category nonfuel vaginal contraceptive. It is a once-a-month nonhormonal contraceptive. There's really nothing like it available today in the contraceptive category. The closest product that has existed to something with a form factor like Ovaprene that 1 month form factor, vaginal is NuvaRing, which is a hormonal product. But when it was still branded, it peaked at almost $1 billion in annual revenue. So Ovaprene was really designed to similar ED a once-a-month vagal product, but to work with that 1 amount. So it has a physical barrier and a chemical that it releases, which is a promeostatic agent. It's in its pivotal Phase III registration study. So this is a study that we used to submit to the FDA. So far, it is performing exactly as predicted. We've had 2 now positive independent data safety monitoring board meetings, 1 last summer and on this summer. And in both cases, the typical use effectiveness based on the pregnancy rates being seen is continuing to perform in the projected range was to 86% to 91%. The adverse event profile has been very consistent throughout the trial as well. And as I mentioned, it has the potential to be the first FDA-approved product of its kind. So right now, based on where we are, we're expecting to complete enrollment to achieve our target of 2,500 cycles and data to evaluate -- we expect to complete that enrollment this year and to have this data available and a top line data readout in 2027 for this product. The other development stage product I want to talk about is DARE HPV, which is our product that's designed to treat human capolovirus eduction -- so human papilloma virus infection is the virus that causes cervical cancer. And despite the fact that we know the virus that causes cynical cancer, there are no FDA-approved products to treat that infection when a woman tests positive, instead, she's told to just wait until that infection can lead to sort of goal lesions or precancer lesions or even cancer solutions, which then have to be surgical remove from the cervix. And so DARE HPV is really designed to be taken right when she has that persistent high-risk infection instead of waiting for her to get those precancerous lesions. So it's in a Phase II trial right now. That trial is funded by ARPA-E, through a contract grant funding mechanism we have from. And we expect to have top line data from this trial in 2027 as well. And then in terms of what's coming down the pipe decks in terms of prescription products on the commercial side is we're working to do the same thing with our DARE to RECLAIM hormone therapy interventional ring as we've done with which is make it available as a 503B compounded product, while we continue activities that would continue to work to advance it through an NDA pathway. And so we're targeting to have this 1 for month hormone therapy product available for commercialization late next year. Menopause is definitely having a moment. There's more pulverization about menopause -- but unfortunately, for women, there is still no product available to be prescribed today that is clinically studied and actually follows the Menopause Society guidelines for menopause on therapy, which is if it's a women the uterus, both progesterone and Estratel, together in 1 product that is nonoral, -- and that is exactly what our estradiol progesterone international rain, once-a-month product is designed to do. So looking forward to keeping update on that. We're actively looking at activities to also support nonhormonal products for menopause and specific regenerator urinary syndrome of menopause, which can lead to sexual pain discomfort. This is a really important side effect that women going through a breast cancer hometapositive breast cancer therapeutic regimen may experience and yet hormonal products are often not recommended for them. So this is a non-hormonal solution that the FDA has cleared for us to start preparations for Phase 2. And then the last 1 I wanted to highlight is our vaginal ring technology with progesterone-only and same kind of technology as we talked about for the hormone therapy product. But progesterone only, for IVF support as well as investigational product for preterm birth. So those are places where progesterone injections or other vaginal forms of progesterone are often used and this is a very convenient national that can release for just over several days. And we do have support from NIH to start a Phase I trial with this product. So we're in preparations for that. So we want that to follow. We have an extensive preclinical pipeline, most of it supported by grants and outside funding, similar first-in-category opportunities that as they advance, we look forward to keeping you updated on. A couple of highlights from the financial perspective. Our last reported cash balance was $18.5 million. The management team at Daré is highly experienced. There are people that come from both experience to be in a team that's experienced both from the clinical development side as well as the commercialization side and women's health specialists as well as general pharmaceutical specialists, which are important in the development kind of development programs that we have. And then I want to end with a couple of slides just really highlighting the near-term catalyst and why Daré why now. So in terms of things to watch for in the coming months and year. First of all, obviously, there's 2 commercial products that are going live this year. At play in for cream for arousal and our drystored forcing LFI bag probiotic, which is available now. Both of those are available on the Daré Health Hub that you can get to by just going to our website, deal bioscience.com. And then we've got the Ovaprene 1 contraceptive clinical readout and the DR HPD clinical readout next year. And then we're working to get that menopause hormone therapy battering commercializes a 53 compounded product next year as well. So stay tuned for that. And I'll just end on the why Daré why now? I started the talk today we're highlighting, it's a great time to get to know us. This is 10 years in the building getting to this point now where we are going to be commercializing 2 products directly 1 prescription, 1 not really looking at all the best ways to get products in the hands of women as quickly as we can. We've got that late-stage pipeline advancing with that nondiluted funding with those clinical readouts next year that are also so important. And then all of it is back with this really scalable commercial platform in place through Daré help Hub and the infrastructure we're building both internally and with our telehealth partnerships to support scalable growth. So with that, I will open it up for questions, and thank you again for listening in today.

Great. Thank you. So to our audience, if you have a question for Sabrina, click the Q&A button at the bottom of your screen and type in your question. So we already have people that are familiar with this process. So we have some questions in queue already Sabrina. -- right. So can you provide an update on the NASDAQ delisting process and whether we should expect any positive development or clarity on retaining the listing?

Absolutely. I mean, obviously, this is important to us, and it's something that we focus on. So the way the process works is basically we were able to request a hearing -- in late July, the panel NASDAQ branch this hearings within 30 to 45 days from their quest at the hearing, we really go in and present our plan for compliance, which is obviously very important to us. And so we present that plan for compliance. And then typically, the P&L takes about 30 days. to respond to that plan that we put forward. So we are in preparation for that. We work for C2 advisers to help us prepare for that and something very important. And we're remaining focused on that. And obviously, all the things we're doing in terms of the products that are launching, all of that, our clinical data, that all becomes a very important part of the narrative that we show with the panels for our compliance strategy and plan as well.

Okay. Our next question, it feels like you have a unique commercialization approach. Can you describe the rationale further and also discuss how your commercial team is comprised?

Yes. So in terms of the rationale for the commercial strategy, so a few of us on the team have backgrounds in pharmaceutical launches historically myself included. I said the first part of my professional career on the commercial side. And as we think about kind of where the world has shifted and where we are today, we really saw an opportunity to lean into where people are getting their care where they're getting their information and how they want to access their products and how they want to pay for their products. And we've seen with telehealth, right, the rise of telehealth, the rise of mail order pharmacies, even before telehealth was the thing the I would say that the larger proportion of people that are really interested in cash pay for products so that as long as they're reasonably priced that they don't have sometimes the complexity and the burden of the prior authorizations and the insurance that they're going through. There are just a lot of things that have shifted. And also, as I mentioned, upfront, kind of where are they trusted versus of information. Health care providers are important in terms of those actual office visits. But the other really trusted source of information about products is health care providers that have that digital platform. Online, right, whether it's a podcast or again, Instagram, Facebook, whatever they're doing to talk. And so we really wanted to lean into that. I mean that's where women are getting information for 1 of the anti products. And because we have products that are actually back in with science and clinical evidence, it opens up all of those channels to us. We don't have to rely on advertising, advertising advertising and spending that way to get a consumer to try something that doesn't have any data behind it because we can't go to a health care provider, right? And we can actually go to those trusted channels. And so that's really what's behind our strategy, and we think it's a more cost-effective strategy that we can leverage. And so we have internal set, we don't have like the traditional big pharmaceutical sales organization again, we just believe that that's not required any more times have changed. We obviously do have professionals who can obviously interact with and really be a partner to the health care provider community to make sure they have the information they need that can partner an entrant relationships and partnerships with telehealth platforms or other organizations that we're going to platform that we're going to partner with and then also to support us in our outreach and our implementation of our digital strategy, which is really leaning into again, podcast, professional.

Ones rather than Daré Kash.

Yes. So we're really right now prioritizing our development programs that are either 100% grant funded or very significantly grand funded. Those are the programs that we're really prioritizing now from a development perspective because then that requires minimal contribution on our part or not as material of contribution on our part to support those programs. And so strategically, that's what we're doing. So right now, it's really -- it's Ovaprene, which is in Phase III, which is -- we historically had a collaborative research agreement with NIH and then more recently, had funding also come through from the Gates Foundation -- so we have had some contribution historically to that program. We'll have a little more budgeted to get through the end of the trial as well, but it's very, very heavily grand supported, as you can tell from the financials. The DARE HPV program, which is 100% supported by both the grant from Arta H as well as NIH. So that's completely grant funded. The DARE program, which is preclinical, which is completely granted -- we have another nonhormonal contraceptive development program, which is completely grant funded. Our CCaS implantable contraceptive is 100% grant funded and is going through Phase I right now. And then we're looking to get our DARE PTV 1, which is a progesterone vaginal ranito Phase I, and that's funded with the grant from the NIH. So those are really the development programs that we're focusing on because they either have 100% or very, very significant grant funding to support them. So that our contribution is not significant.

Next question does my menopause Rx direct eligible patients back to Dare -- or does it prescribe, footfill and ship directly to the patient.

Yes. Good question. So it's a great example of the kind of relationships that were really prioritizing with those kind of digital health platforms, which is they prescribe the product, right? And that -- which is what they do best. They prescribe products for their patients. And when they prescribe it, they can access it right through their bioidentical record system. It goes right to the midbanks pharmacy that we work with and then that fulfillment can and be handled centrally. So it's just a super efficient channel. It leverages the logistics, the pharmacy, fulfillment, which, by the way, includes all the things we're also used to having, right? The pharmacy texting us on our prescriptions ready, when it's coming, when is it time for a refill, right? So it gets to leverage all that back end that we've built through mid -- but they are educated about our products and know about our product and know how to prescribe it, so they're ready for their patients, but it's so helpful for us to have that relationship with a trusted and truly specialists in women's health so that when patients come to women come to our platform and are looking for not just the asynchronous telehealth visit, which we offer, which is great. Like if you know you want gear to play and you are ready and you want your prescription it's fantastic. It's a 10-minute I think it's questionnaire. But sometimes, we want more than that, right? We want we want to talk about other things. We want to have an interaction with the health care provider. It's so hard to find a health care provider that is truly expert and, in this case, menopause care, but also is not like kettling a bunch of products that they made themselves, right? It is going to provide clinic-tolutions. So those are the kind of relationships that we love and want to enter into more of. So win-win.

Perfect. Our next question, what is revenue guidance for the current year and next year?

Yes, we haven't provided any guidance yet. But what I will think of it early gains of Flora Sync LF5 launch and data pricing that for Cream hasn't expense yet. But what I can talk about are what are some of those key performance indicators that we're going to be looking for. What are we watching in the launches, right? So when I think about either flooring which nonprescription or dartyplace then aacream, what we're going to be watching for from the consumer perspective is where does she come from, right? How did she get to that product, right? So we'll be watching to understand that where it should come from. And then what is her use behavior, right? How often does you use the product, how often does she reorder right, so that we can understand the average kind of limited perspective and based on where she comes from, how are she using the product calicincorporating those into a routine. From the provider perspective, we're going to be looking for our base stocking the products, right? And if they're stocking the products, are they dispensing more frequently than maybe someone that's not stocking the products and those different behaviors what are the repeat prescribing behaviors at a prescriber, we want raphe prescribers, but we want depth, right? We want to see that a product has been integrated into their clinical practice. So they're tingrepeat prescriptions. That's super important. So those are the kind of things that we're going to be looking for in the early days of launch. And all of that really feeds into us being able to understand customer acquisition costs. And what are our most effective channels so that those could be the ones that we're reinvesting in.

Perfect. I have a question. You had talked about your different approaches using the social channels and really innovative ways. And trusted ways of really doing your marketing. So being science-based and having real solutions for women, do influencers come to you? Do the telehealth providers come to you to I would imagine. I would imagine they would because there's not a lot of credible sources for solutions for women out there that are science back that have the standards that you apply to your products.

Yes. Thank you for highlighting that. They absolutely do. Those both ways. There are people that we seek out right, because we want to make sure they know about what we're doing and what a fit we may be for what they're doing. And we want to make sure that they have the information they need and then also, right, there are people that reach out to us and say, we'd love for you to be on this podcast. And we'd love to -- can you provide us just some materials so that we have nice images and right, things to share on our platform because we really want to make sure we get content out about this. So it goes both ways. And that is 1 of the things that I think is distinct here, right? We're not having to rely on having to buy our way all 100% buy our way into the consumer's mind, right? There's fiat you need to build awareness. Right? But we're able to do that through earned channels because of the work that we've done.