Q4 2023 Dare Bioscience Inc Earnings Call

Participants

Sabrina Martucci Johnson; President and CEO; Dare Bioscience, Inc.

MarDee Haring-Layton; Chief Accounting Officer; Dare Bioscience, Inc.

Douglas Tsao; Analyst; H.C. Wainwright & Co., LLC

Will Hidell; Analyst; Brookline Capital Markets

Presentation

Operator

Welcome to the conference call hosted by Daré Bioscience to review the company's fourth quarter financial results and to provide a general business update. This call is being recorded. My name is Lisa 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. Johnson, please proceed.

Sabrina Martucci Johnson

Thank you. Good afternoon, and welcome to the Daré Bioscience financial results and business update call for the year ended December 31, 2023. Today, we'll review our financial results for 2023 and discuss developments and expectations for our pipeline and portfolio. Before we began, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.
Any statements made during this call that are not statements of historical fact should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-K for the year ended December 3, 2023, which was filed today.
I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, March 28, 2024. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As you know, women's health is our sole focus at Daré. Women's health products make up 27% of total blockbuster products, while contributing to 35% of total blockbuster sales, and there continue to be many unmet needs in the market.
To our knowledge, Daré is the only publicly traded company focused solely on women's health pharmaceutical product development broadly, and we remain committed to advancing through clinical development, regulatory review, and ultimately to market disruptive products for women. Our commitment and focus is to make a difference for women in a relatively efficient timeline, by leveraging the basic science and pharmacology that is understood about certain active pharmaceutical ingredient and marketed products to accelerate innovative treatments that women want and need. We seek to optimize these treatments for our target indications to enhance outcomes, convenience, and side effect profile, or to address a novel indication where the pharmacology is well seeded, but has not previously been applied to the indication in question for women.
We believe we have built a premier company in women's health, with the broadest portfolio of potential high impact, first and category product candidates; many of which have already demonstrated proof of concept. And that our robust pipeline of product candidates positions us well for the short, medium and long-term. I'm excited to share today, the strides we made in 2023 to advance innovative therapies for women, updates on our most promising near-term opportunities, and the milestones we look forward to in 2024. In 2023 alone, Daré had 15 interactions with the FDA across six product candidates, indication. Completed the Phase 2b study of our investigational Sildenafil Cream product for female sexual arousal disorder and the Phase 1 study of our investigational vaginal diclofenac product for menstrual pain.
We received IND clearance for DARE-VVA1, our hormone-free candidate for sexual pain, and we commenced the Phase 3 study for our investigational hormone-free monthly contraceptive candidate Ovaprene. Before we continue, I also want to acknowledge a few recent industry developments that underscore what a fantastic time it is to be working in women's health and the significant opportunity in this space. As you may know, in November of 2023, the White House announced the first ever White House initiative on women's health research, an effort led by first lady, Dr. Jill Biden, and the White House agenda Policy Council to bring together congressional leaders, the private sector, research institutions, and philanthropy to quote, fundamentally changed how we approach and fund Women's Health Research.
In February 2024, Daré was invited to participate in an ARPA-H ideation event, where Dr. Jill Biden announced, along with ARPA-H leadership, the $100 million deployment of capital for women's health. Earlier this month, the president called on Congress to make bold transformative investment of $12 billion in new funding for women's health research. And just last week, I had the honor and privilege of attending a reception at the White House in honor of Women's History Month, where President Biden signed an executive order dedicated to advancing women's health research. It's encouraging to see further comprehensive executive action aimed at increasing investments in women's health and making it a priority in various ways, because initiatives like these brings focus, bring financial support for the entire ecosystem to boldly innovate for women.
Even more, these positive tailwinds can be expected to boo in investors' interest and funding in this sector long term. Most importantly, we believe our achievements in 2023 demonstrate that our approach to accelerating clinical development works and that our leading programs have disruptive potential in the conditions and populations they aim to treat along with significant revenue potential, if approved. I'm going to put those 2023 accomplishments and our anticipated 2024 milestones into further perspective shortly, particularly in the context of metrics that are important to any current or future shareholder, specifically, the addressable market, their probability of success, and what it would take to advance the programs, with a focus on our on-market asset, XACIATO, and our Phase 3, Ovaprene and Sildenafil Cream. Before I do so, I'm going to first turn it over to our Chief Accounting Officer, MarDee, to review the 2023 financial results.

MarDee Haring-Layton

Thanks, Sabrina, and thanks, everyone, for joining us today. By way of introduction, my name is MarDee Haring-Layton, and I've been at Daré for more than six years, previously serving as the Vice President of Accounting and Finance since October 2018. I'm excited to be here with you all. I will summarize Daré's financial results for the full year 2023. But before I do, I would like to put them in context for those of you who are newer to the story.
Daré's business strategy is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs we've identified in women's health, and then monetize the value of our portfolio's clinical and regulatory advances over the near and long-term. The investment required to build in advance of portfolio includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses. During 2023, we recognized total revenue of approximately $2.8 million, which included a $1 million payment in July 2023, and an additional $1.8 million milestone payment in October 2023 from our commercial collaborator, Organon, relating to XACIATO, the first FDA-approved product to emerge from our portfolio, as well as a nominal amount of royalty revenues based on net sales of XACIATO during the fourth quarter.
XACIATO became more widely available by prescription to treat bacterial vaginosis in January of this year. Our general and administrative or G&A expenses were approximately $12.1 million, which was up slightly compared to the prior year. Our R&D expenses across our entire portfolio were approximately $21.5 million, and primarily reflected the costs of our Phase 1 and Phase 2b study of Sildenafil Cream, our Phase 1 study of DARE-PDM1, vaginal diclofenac for menstrual cramping and manufacturing activities, as well as preparing for and beginning enrollment in our Phase 3 study of our intervaginal, hormone-free monthly contraceptive candidate, Ovaprene. As a reminder, R&D expenses vary from period to period based on our clinical, preclinical, manufacturing, regulatory, and other development activities. We reported a net loss for 2023 of $30.1 million and ended the year with approximately $10.5 million in cash and cash equivalents.
During the year, we received approximately $4.7 million in non-dilutive grant funding. We also completed a $7 million registered direct offering in September, and a $12 million royalty backed investments in December; of which, we took down $5 million in December. The remaining $7 million is available to us to take down through three tranches over time at Daré's options. The financing structure entitles investor to a percentage of the royalty and milestone payments to be received by Daré, under its global license agreement for XACIATO with Organon, only until the investor achieves a targeted return on investment.
As of March 27, 2024, Daré had approximately 100 million shares of common stock outstanding. Since our inception, we have made fiscal responsibility a top priority, maintaining a lean and focused team, and managing our overhead costs closely. To that end, we expect a reduction in our 2024 G&A expenses to approximately $10 million, which to be clear, does not reflect $10 million in capital required to fund G&A expenses, since approximately $3 million of that estimate is estimated accrual based non-cash expenses. In addition, as previously noted, our R&D expenditure is predicated on ongoing development programs.
In 2023, we had four active clinical studies that contributed to our $21.5 million of R&D expenditures. In 2024, our only active clinical study at this time is our Phase 3 pivotal Ovaprene study, for which, we have already remitted in prior years, all but $0.5 million of funds due to the NIH under our cooperative research and development agreement. And therefore, planned Ovaprene expenses in the 2024 year will be primarily associated with certain manufacturing activities. Apart from Ovaprene related expenses, our currently projected 2024 R&D expenses are primarily carryover/close-out expenses from the studies completed in 2023.
Therefore, until such time, as we commence an additional late-stage clinical study, we anticipate 2024 R&D expenses to be considerably less than the 2023 R&D expenses. Looking ahead, we will continue to evaluate a wide range of financing opportunities, including more creative and innovative alternatives to fund our broad portfolio of differentiated product candidates, which we believe, opens the door to financing opportunities that other companies may not have access to. These opportunities may include, but are not limited to non-dilutive grants, as we have for many of our preclinical programs, and these earlier-stage programs with grant funding enhance our pipeline: equity sales, license agreements, structured financing, and strategic collaborations or alliances. We will continue to explore a variety of options to fund our operations, advance our candidates, monetize the value of our assets, and build shareholder value.
As we've said previously, we look to be creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value. We believe our December financing met that goal, and we'll work to identify similar opportunities moving forward. We also encourage investors to review the more detailed discussion of our financial condition, liquidity, capital resources, and risk factors on our Form 10-K for the year ended December 31, 2023, which we filed this afternoon. I would now like to turn the call back over to Sabrina.

Sabrina Martucci Johnson

Thank you. As I mentioned earlier, I'm now going to put our 2023 accomplishments and our anticipated 2024 milestones into the context of their potential, including the addressable markets for our product candidates, their probability of success, and what it will take to advance them, with the focus on our on-market asset XACIATO and Phase 3 asset, Ovaprene and Sildenafil Cream. But first, a high-level statement on R&D spend that MarDee just discussed. So over the last few years, our R&D spend has averaged around $26 million per year, despite the fact that we have typically had multiple ongoing clinical studies in any one-year. For context, late-stage development studies for the women's health indications we are pursuing are generally in the tens of millions, compared to hundreds of millions can be the case in other indications and therapeutic categories.
This is in part what has contributed to our capital efficient model. Historically, industry-wide, we see this trend. Only 1% of healthcare investment has gone into women's health and that 1% investment though has generated 27% of the blockbuster brands. That is reflective of what we believe is the efficiency of the women's health investment thesis and that we're leveraging in our programs.
So now, to transition to our programs, in the fourth quarter of 2023, we achieved our first commercial milestone for XACIATO. And now, in the first quarter of 2024, XACIATO is available by prescription across the United States. As reminder, XACIATO, which is clindamycin phosphate vaginal gel, is a colorless, single-dose vaginal gel that can be applied at any time of day and is formulated with the goal of limiting leakage and increasing vaginal retention time, which is time spent in place. XACIATO is indicated for the treatment of bacterial vaginosis in females, 12 years of age and older in the United States.
And since this product is already on market, I'll focus on the what's it worth. In the context of the potential patient population and our commercialization agreement with Organon, the prevalence of bacterial vaginosis in the United States is estimated to be 23 million women. And as an on-market product, XACIATO, represents a non-dilutive source of revenue for Daré. We are eligible to receive double digit royalties and up to $180 million in milestone payments from Organon.
We look forward to providing that quarterly revenue updates that we booked, as we receive them from Organon. And we are impressed with Organon to go to market strategy that leverages the knowledge and experience of their established NEXPLANON commercial team. In 2023, we also shared positive data from our exploratory Phase 2b RESPOND study of Sildenafil Cream, as a treatment for female sexual arousal disorder. In terms of market and revenue potential, there are no FDA approved treatments for any form of sexual arousal disorder in women; and therefore, Sildenafil Cream has the potential to be the first.
Sildenafil is the active ingredient in tablet form for oral administration, currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men, which was undoubtedly one of the most successful prescription products ever launched. Market research suggests that approximately 20 million women in the US experience symptoms of low or no sexual arousal. We believe this is a promising untapped market, given the numerous equivalent products approved for men, not only Viagra but also Cialis, [Lee tried], to name a few, and Viagra alone generated $2 billion annually at its peak. In terms of probability of success, we've already demonstrated that Sildenafil Cream increased genital tissue blood flow in quantitative studies.
And in the Phase 2b at-home study, that was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them that best reflect that improvement so that we could take those forward into the Phase 3 clinical development. The patient population and the endpoints we have proposed to the FDA are the ones where our post-hoc analyses of the Phase 2b study data showed that Sildenafil Cream demonstrated a statistically significant and meaningful patient improvement. In terms of next steps and what it will take to bring Sildenafil Cream through Phase 3 and to a potential approval? Well, we had a positive end of Phase 2 meeting with the FDA in December of 2023, and we are continuing to interact with them as they review, in particular, the data we generated on the proposed endpoints to take forward into Phase 3.
The Phase 2b study was importantly the first study of its kind, and the FDA has indicated they anticipate giving us additional feedback on the Phase 3 design in the second quarter of 2024. We've already aligned that female sexual arousal disorder, FSAD, is an approvable indication, as well as the opportunity to perform the efficacy assessments after just 12 weeks of use. Based on the feedback received to date and the effect size that we saw on multiple measures of sexual function in the patient population, we've identified to take forward into Phase 3. We would anticipate the cost of the Phase 3 efficacy trial to be comparable to the cost in the Phase 2b study, so, specifically, in the $15 million range for each efficacy study.
We look forward to providing further updates on the FDA discussions, the Phase 3 designs and plans and any relevant updates on our collaboration strategy. In 202, we also commenced our pivotal Phase 3 study of Ovaprene are potentially first in category, hormone-free, monthly inter-vaginal contraceptive candidate. In terms of market and revenue potential, we believe Ovaprene has the potential to be a disruptive product in the contraceptive category, and potentially life-changing for women who cannot take hormone-based birth control products or those who would prefer not to do so. In addition to providing innovation as a hormone-free contraceptive, the clear differentiation and disruptive potential of Ovaprene is in its convenience and potential efficacy.
Its convenience includes easy, monthly use, and self-administration, without requiring action at the time of intercourse. And we believe Ovaprene has the potential to demonstrate efficacy approaching hormonal birth control methods. There are currently no FDA-approved monthly hormone-free contraceptive. And based on market research, approximately 35 million women in the US are potential candidates for Ovaprene.
We see parallels to NuvaRing when it entered the market as the first monthly inter-vaginal (technical difficulty) contraceptive. And at peak, it generated $900 million in annual revenue. Bayer is a leader in commercializing contraceptive products in the United States, and they hold the right to obtain US commercial rights to Ovaprene under their license agreement with us. Under that agreement, we're eligible to receive a $20 million milestone payment at Bayer sole discretion, following the completion of the ongoing Phase three study, as well as up to $310 million in commercial milestones and double-digit tiered royalties.
And in terms of probability of success, the pre-pivotal study that we completed before we entered into our commercialization collaboration with Bayer, indicated that Ovaprene had the potential to demonstrate typical use contraceptive effectiveness, approaching user-controlled hormonal contraceptive, but without the use of hormones. And in terms of next steps in bringing Ovaprene toward potential approval, the pivotal study is a multicenter, single-arm non-comparative Phase 3 contraceptive study of Ovaprene, to evaluate its effectiveness as a contraceptive, along with its safety and usability over the course of approximately 12 months of use. Based on communications to date with the FDA, if successful, we believe that just the single registration study will be required to support a premarket approval application submission with the FDA.
As mentioned by MarDee, in previous periods, we remitted funds, specifically $5 million, to the NIH to support study activities. In addition to that, we are responsible for manufacturing activities and certain external activities, such as the advertising campaign for the study. And as of this month, the central advertising campaign for the study is live and enrollment is well underway at 17 sites across the United States. Since the Phase 3 is a 12-month study that commenced late last year, we will not have final data this year, but it is an open label study, and therefore, we will look forward to providing recruitment and any relevant data updates in the coming quarters.
So in summary, I'm very excited about the incredible progress we made last year and the promise that 2024 holds for Daré. Our investigational products to some of the most potentially disruptive candidates for women in decades, and we collaborate with leading companies, including Organon for XACIATO and Bayer for Ovaprene, to commercialize and deliver these treatments to as many women as possible. And we do all of this, the thoughtful and efficient capital deployment and by leveraging nondilutive sources of capital wherever feasible. I'd now like to turn the call over to the operator for Q&A.

Question and Answer Session

Operator

(Operator Instructions) Douglas Tsao, H.C. Wainwright.

Douglas Tsao

Hi, good afternoon, thanks for taking the questions. Sabrina, I know you're not responsible for commercialization, but it would maybe be helpful just to provide a little perspective on the exact status of the XACIATO launch, just given -- the scripts aren't really necessarily taking off and are scripts fully reflective of what's going on in the market? I know, with some products going through specialty pharmacies, on [IQVIA] isn't necessarily capturing everything. Thank you.

Sabrina Martucci Johnson

Yeah, no, thank you. That's a great question. So first of all, yeah, absolutely, I think as we're all aware, with different product brands and different types of launches. And so the advent of specialty pharmacies and the time, some of our historic data sources on Folsom, as maybe we've gotten accustomed with other products. So what I can say, specifically, about the XACIATO are a few things that obviously have already been said by our commercialization, collaborator, Organon.
So first of all, while launch activities in terms of us meeting our commercial sales milestone commenced in 2023, as Organon put out the press release in January of this year, the product became available nationwide in January. So that's really when certain activities, obviously, commenced in terms of the product availability. Obviously, we're in early days of launch, just given that we're literally just months in at that, in terms of the timing of the products really becoming available. And so, that's why we're looking forward to the year and the activities that are projected for this year.
The product, as I mentioned, is in the hands of their NEXPLANON sales force. We've previously talked about the reason that we selected Organon and their NEXPLANON commercial team, quite frankly, for this product, in terms of the overlap, in terms of the provider base that prescribes contraceptives, as well as those that prescribe and treat bacterial vaginosis, which is primarily a condition of women of reproductive age. Any opportunity for those sales reps to ensure that clinicians and the right providers get an experience with the product and that the product is available through all of the appropriate channels. And so beyond that, we are I can say, very enthusiastically, we are very happy with the work that Organon is doing and the progress that they're making with the brand, and what they have planned and what they're executing on with the brands this year.
And we're very much looking forward to giving you updates as the year continues and particularly as those royalty revenue dollars show up in our income in our financial statements.

MarDee Haring-Layton

And Sabrina, maybe as a follow up, so Organon made the product fully available nationally in January. I mean, do you know when it's had the full attention of the NEXPLANON sales force? And do you know the relative position in the rep's bag between NEXPLANON and XACIATO?

Sabrina Martucci Johnson

Yeah, so obviously we can't on any of the information, as you can appreciate might be proprietary obviously to Organon. But what we can say is that again, we selected them because of the NEXPLANON sales force. And part of the beauty of that is that sales force only had NEXPLANON in their bag prior to XACIATO. And so, anyone who's been in sales situation or selling situation understands how important it is to have more than one product in the bag, how value that's the value that can be how important it is to have something novel to talk with the healthcare provider about, especially when it's a condition like bacterial vaginosis which can be very frustrating historically for providers when treatment options were didn't suit their patients maybe as well as they hope and didn't have some of the features that XACIATO has.
And so we really selected Organon because of the attention in the commercial organization that this product would guide, and particularly, that it would be in the hands of a commercial organization that really would only have these two products to be promoting. And obviously, NEXPLANON is a very important brand, obviously, for Organon, as you've seen in their own numbers. But this gives that sales organization something novel right to talk about in terms of XACIATO. Beyond that, in terms of the specifics, I mean, I can't add.

MarDee Haring-Layton

Okay, thank you so much.

Sabrina Martucci Johnson

Absolutely.

Operator

(Operator Instructions) Will Hidell, Brookline.

Will Hidell

Hi, thank you for taking the questions. I just have one quick question, regarding the other trials, the VVA1, PDM1, HRT1, what is your plan going forward with these trials? Do you have a priority or an emphasis on any of them?

Sabrina Martucci Johnson

Absolutely. Great questions, and thanks for highlighting some of the other disruptive products in the portfolio. And so, with all of the other programs, we're really at a stage with the various programs, whether certain preparatory, I would describe them activities that are under way. And so for instance, with HRT1, we have had interactions with the FDA that we have, obviously, be published a number of the outcomes of the two different studies that we've run with that product in humans. And we have had interactions with the FDA in order to prepare for an IND submission, as well as get clarity that just the one pivotal study would be required to support registration.
We are currently conducting the activities necessary to enable the submission of the IND application, so that we can then start that pivotal Phase 3 clinical trial. So we are still undergoing the activities that the FDA has communicated to us that are needed to support that IND. And so, that's ongoing. As soon as we have an update on that, we will definitely provide that update. And then that timing will obviously be important in determining next steps.
But the next steps with that program with the FDA and the submission, its next phase, would be to go into a single Phase 3 registration study. And then in terms of VVA1, and as I mentioned, and as you noted that we have the IND application that is cleared and was supported by our Phase 1/2 results that we had generated last year. So at this stage, I mean, we're definitely doing activities that would support preparations to moving into a Phase 2 study in terms of identifying clinical sites, protocol preparation, things like that. We don't plan to conduct the Phase 2 study until after we secure additional capital that was supported, but the next phase for that program would be the Phase 2.
And as part of our IND process, we got really great feedback from the FDA on the Phase 2 design, so that we can ensure that that would put the product where it needs to be to advance after that and really leverage dispersed and category opportunity as a non-hormonal product for sexual pain. (multiple speakers)

MarDee Haring-Layton

Okay, thank you.

Sabrina Martucci Johnson

Yes, absolutely. Yes, we are doing all we can to get them ready to move forward.

MarDee Haring-Layton

Yeah, thank you.

Sabrina Martucci Johnson

Absolutely.

Operator

And with that, that concludes the question-and-answer session. I would like to turn the call back over to Sabrina Martucci Johnson for any additional or closing remarks.

Sabrina Martucci Johnson

Well, thank you, guys, for taking the time this afternoon and the afternoon before the holiday weekend for some. Thank you for taking the time to hear about our recent updates and our ongoing commitment to drive value for all Daré stakeholders by transforming women's health. As you heard today, we made important progress in 2023 with our novel investigational treatment options that have the potential to expand choices and improve health outcomes. And we continue to work towards the goal of bringing innovative new treatments to market every day.
We expect to have numerous 2024 milestones, including the quarterly revenue updates on XACIATO, as that launch progresses this year, Ovaprene pivotal study updates as we work to complete what we expect will be a single registration study, and updates on our discussions with the FDA and activities to commence Phase 3 for our potential first in category, treatment option for women with female sexual arousal disorder, our Sildenafil Cream program. And while not the focus of today's call, our grant funded product candidates enhanced the portfolio, and we look forward to providing relevant updates on those ongoing programs as well this year. With our unique model support of our commercial collaborators and focus on fiscal responsibility, we believe are well positioned to accelerate innovation for women, in a manner that also drive shareholder value.
We look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you again for your time and your questions.

Operator

Thank you. And that does conclude today's presentation. Thank you for your participation today, and you may now disconnect.