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spk08: Welcome to the conference call hosted by DARE 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 DARE are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Marty Herring-Layton, Chief Accounting Officer. Ms. Johnson, please proceed.
spk10: Thank you. Good afternoon and welcome to the DARI Bioscience Financial Results and Business Update call for the year ended December 31st, 2023. Today, we'll review our financial results for 2023 and discuss developments and expectations for our pipeline and portfolio. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical fact should be considered forward-looking statements. Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-K for the year ended December 31, 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. DARE 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 DARE. 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, DARI 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 ingredients 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-suited 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 in 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, DARI had 15 interactions with the FDA across six product candidate syndications. completed the Phase 2B study of our investigational subendophyll 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 DER-VVA1, our hormone-free candidate for sexual pain, and we commenced the Phase 3 study for our investigational hormone-free monthly contraceptive candidate, oviprene. 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 Gender Policy Council to bring together congressional leaders, the private sector, research institutions, and philanthropy to, quote, fundamentally change how we approach and fund women's health research. In February 2024, Dara 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 bring focus, bring financial support for the entire ecosystem to boldly innovate for women. Even more, these positive tailwinds can be expected to buoy investor interest and funding in the 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 markets, their probability of success, and what it will take to advance the programs with a focus on our on-market assets, Zasciato, and our Phase III assets, Oviprene and Sildenafilprene. Before I do so, I'm going to first turn it over to our Chief Accounting Officer, Marty, to review the 2023 financial results.
spk05: Thanks, Sabrina, and thanks, everyone, for joining us today. By way of introduction, my name is Marty Herring-Layton, and I've been at DARE for more than six years, previously serving as the Vice President of Accounting and Finance since October 2018. I am excited to be here with you all. I will summarize DARI'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. DARI'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 and advance a 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 Zasciato. the first FDA-approved product to emerge from our portfolio, as well as a nominal amount of royalty revenues based on net sales of Zosciato during the fourth quarter. Zosciato 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 I and Phase IIb studies of sildenafil cream, our Phase I study of DER PDM-1 vaginal diclofenac for menstrual cramping, and manufacturing activities, as well as preparing for and beginning enrollment in our Phase III study of our intervaginal hormone-free monthly contraceptive candidate, oviprene. 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 investment 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 DARE's option. The financing structure entitles the investor to a percentage of the royalty and milestone payments to be received by DARE under its global license agreement for Zasciata with Organon, only until the investor achieves a targeted return on investment. As of March 27, 2024, DARE 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 III pivotal oviprene study. for which we have already remitted in prior years all but half a million of funds due to the NIH under our Cooperative Research and Development Agreement. And therefore, planned oviprene expenses in the 2024 year will be primarily associated with certain manufacturing activities. Apart from oviprene-related expenses, our currently projected 2024 R&D expenses are primarily carryover slash closeout 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 financings, 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 will 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 31st 2023, which we filed this afternoon. I would now like to turn the call back over to Sabrina.
spk10: 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 a focus on our on-market assets, Ashiato, and Phase III assets, Evapreen and Savenafil Cream. But first, a high-level statement on R&D spend that Marty 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, this can be the case in other indications of 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 Zasciato. And now in the first quarter of 2024, Zasciato is available by prescription across the United States. As a reminder, Zasciato, 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. Zasciato 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, Zasciato represents a non-dilutive source of revenue for DARE. 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 update that we book as we receive them from Organon And we are impressed with Organon's 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 face-to-be response 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, sidenafil cream has the potential to be the first. Sidenafil 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 U.S. 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 and Levitra, 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 sedentifil 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 sobenafil 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 IIb study data showed that sildenafil cream demonstrated statistically significant and meaningful patient improvements. In terms of next steps and what it will take to bring sildenafil cream through Phase III and to a potential approval, well, we had a positive end to Phase II 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, or 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 III, we would anticipate the cost of a Phase III efficacy trial to be comparable to the cost of the Phase IIb 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 three designs and plans, and any relevant updates on our collaboration strategy. In 2023, we also commenced our pivotal phase three study of oviprene, our potentially first in category hormone-free monthly intravaginal contraceptive candidate. In terms of market and revenue potential, we believe oviprene 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 oviprene 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 oviprene has the potential to demonstrate efficacy approaching hormonal birth control methods. There are currently no FDA-approved monthly hormone-free contraceptives, and based on market research, approximately 35 million women in the U.S. are potential candidates for oviprene. We see parallels to NuvaRing when it entered the market as the first monthly intravaginal hormone 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 U.S. commercial rights to Obaprene under a license agreement with us. Under that agreement, we're eligible to receive a $20 million milestone payment at Bayer's sole discretion following the completion of the ongoing Phase III 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 oviprene 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 Oviprene toward potential approval, the pivotal study is a multicenter, single-arm, non-comparative phase three contraceptive study of Oviprene 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 this single registration study will be required to support a premarket approval application submission with the FDA. As mentioned by Marty, 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 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 DARE. Our investigational products are some of the most potentially disruptive candidates for women in decades, and we collaborate with leading companies, including Organon for Zosciato and Bayer for Obaprene, to commercialize and deliver these treatments to as many women as possible. And we do all of this with thoughtful and efficient capital deployments and by leveraging non-dilutive sources of capital wherever feasible. I'd now like to turn the call over to the operator for Q&A.
spk08: Thank you. Thank you for attending the conference call. If you would like to ask a question on the phone lines today, please press star 1 on your telephone keypad. To remove yourself from the queue, it is star 1 again.
spk00: We'll pause for a moment. take our first question from Douglas Tell with HCU Wainwright.
spk02: Hi, good afternoon, and 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 Zasciata 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, IQVIA isn't necessarily capturing everything. Thank you.
spk10: 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 sort of the advent of specialty pharmacies, sometimes some of our historic data sources aren't fulsome. as maybe we've gotten accustomed with other products. But what I can say specifically about the Zasciata launch 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 via 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, if that, in terms of the timing of the product really becoming available. And so, you know, that's why we're looking forward to the year and the activities that are projected for this year. You know, the product, as I mentioned, is in the hands of their Nexplanon Salesforce. You know, 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, and the 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. So, you know, beyond that, you know, we're, 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. you know, and what they have planned and what they're executing on, you know, with the brands this year. And, you know, we're very much looking forward to getting updates as the year continues and particularly as those, you know, royalty revenue dollars show up in our financial statements.
spk02: And Sabrina, maybe as a follow-up, just so Organon made the product fully available nationally in January. I mean, do you know when it sort of had the full attention of the Nexplanon sales force and do you know the relative position in the reps bags between Nexplanon and Zasciata?
spk10: Yeah so obviously we can't you know comment on you know any any of the information as you can appreciate might be you know proprietary obviously to Organon but What we can say is that, again, we selected them because of their Nexplanon Salesforce. And part of the beauty of that is that Salesforce only had Nexplanon in their bag prior to Zasciato. And so, you know, anyone who's been in a sales situation or a selling situation understands how important it is to have more than one product in the bag, how valuable 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 weren't you know, didn't suit their patients maybe as well as they hope and didn't have some of the features that Zasciato does. And so, you know, we really selected Organon because of the attention in the commercial organization that this product would get, 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 Zasciato. But beyond that, in terms of the specifics, I can't add.
spk12: Okay. Thank you so much.
spk09: Absolutely.
spk07: As a reminder, everyone, that is star one to ask a question.
spk08: We'll take our next question from Will Heidel with Brookline Capital Markets.
spk04: Hi, thank you for taking the questions. I just have one quick question. Regarding the other trials, the VBA one, PDM one, HRT one, what is your plan going forward with these trials? Do you have a priority or emphasis on any of them?
spk10: Yeah, no, absolutely. Great questions. And thanks for highlighting some of the other, you know, disruptive products in the portfolio. And so, with all of those other programs, we're really at a stage with those various programs where there's certain, you know, preparatory, I would describe them, activities that are underway. So, for instance, with HRT1, We have had interactions with the FDA. So we have, you know, obviously we've published a number of the outcomes of the two different studies that we 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 for, so that we can then start that pivotal phase three 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 until we, and that's ongoing, so as soon as we have an update on that, we will definitely, you know, provide that update. And then that timing will obviously, you know, be important in determining next steps. But the next steps with that program would be, after IND submission, its next phase would be to go into a single phase three registration study. And then in terms of VBA1, as I mentioned and as you noted, so 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, you know, identifying clinical sites, protocol preparations, things like that. We don't plan to conduct the Phase II study until after we secure additional capital that would support it, but the next phase for that program would be the Phase II, and as part of our IND process, we got really great feedback from the FDA on the Phase II design so that we could ensure that that would put the product where it needs to be, you know, to advance after that and really leverage kind of this first-in-category opportunity as a non-hormonal product for sexual pain. Okay, thank you. Yeah, absolutely. Yeah, so, you know, doing all we can to get them ready to move forward.
spk04: Yeah, thank you.
spk09: Absolutely.
spk08: 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.
spk10: Well, thank you. Thanks for taking the time this afternoon and the afternoon before the holiday, sort of holiday weekend for some. So thank you for taking the time to hear about our recent updates and our ongoing commitment to drive value for all of DARI 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 Zosciato 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 three for our potential first in category treatment option for women with female sexual arousal disorder, our Sedentafil 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 we're well-positioned to accelerate innovation for women in a manner that also drives 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.
spk08: Thank you. And that does conclude today's presentation. Thank you for your participation today, and you may now disconnect. Thank you. Thank you. So, Thank you. Welcome to the conference call hosted by DARE 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 DARE are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Marty Herring-Layton, Chief Accounting Officer. Ms. Johnson, please proceed.
spk10: Thank you. Good afternoon and welcome to the DARI Bioscience Financial Results and Business Update call for the year ended December 31st, 2023. Today, we'll review our financial results for 2023 and discuss developments and expectations for our pipeline and portfolio. Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meeting 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 31st, 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. DARE 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 DARE. 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, DARI 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 ingredients 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-suited 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-in-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, DARI had 15 interactions with the FDA across six product candidate syndications. Completed the Phase 2b study of our investigational submethyl 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 DER-VVA1, our hormone-free candidate for sexual pain, and we commenced the Phase 3 study for our investigational hormone-free monthly contraceptive candidate, oviprene. 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 Gender Policy Council to bring together congressional leaders, the private sector, research institutions, and philanthropy to, quote, fundamentally change how we approach and fund women's health research. In February 2024, Dara 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 bring focus, bring financial support for the entire ecosystem to boldly innovate for women. Even more, these positive tailwinds can be expected to buoy investor interest and funding in the 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 markets, their probability of success, and what it will take to advance the programs with a focus on our on-market assets, Zasciato, and our Phase III assets, Oviprene and Sildenafilprene. Before I do so, I'm going to first turn it over to our Chief Accounting Officer, Marty, to review the 2023 financial results.
spk05: Thanks, Sabrina, and thanks, everyone, for joining us today. By way of introduction, my name is Marty Herring-Layton, and I've been at DARE for more than six years, previously serving as the Vice President of Accounting and Finance since October 2018. I am excited to be here with you all. I will summarize DARE'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. DARE'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 and advance a 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 Zasciato, the first FDA-approved product to emerge from our portfolio, as well as a nominal amount of royalty revenues based on net sales of Zasciato during the fourth quarter. Zasciato became more widely available by prescription to treat bacterial vaginosis in January of this year. Our general and administrative, or GNA, 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 I and Phase IIb studies of sildenafil our phase one study of DARE PDM-1 vaginal diclofenac for menstrual cramping and manufacturing activities, as well as preparing for and beginning enrollment in our phase three study of our intervaginal hormone-free monthly contraceptive candidate, oviprene. 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 investment 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 DARE's option. The financing structure entitles the investor to a percentage of the royalty and milestone payments to be received by DARE under its global license agreement for Zasciata with Organon, only until the investor achieves a targeted return on investment. As of March 27, 2024, DARE 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 III pivotal oviprene study, for which we have already remitted in prior years all but half a million of funds due to the NIH under our Cooperative Research and Development Agreement. and therefore planned oviprene expenses in the 2024 year will be primarily associated with certain manufacturing activities. Apart from oviprene-related expenses, our currently projected 2024 R&D expenses are primarily carryover slash closeout 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 financings, 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 will work to identify similar opportunities moving forward. We also encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors on our Form 10-K for the year ended December 31st, 2023, which we filed this afternoon. I would now like to turn the call back over to Sabrina.
spk10: 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 a focus on our on-market assets, Asciato, and Phase III assets, Evapreen and Savenafil Cream. But first, a high-level statement on R&D spend that Marty 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, as can be the case in other indications of 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. And now, in the first quarter of 2024, that shadow is available by prescription across the United States. As reminders, which is close to minus and phosphate. Vaginal gel is a colorless. Single does 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. Zasciato 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, Zasciato represents a non-dilutive source of revenue for DARE. 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 update that we book as we receive them from Organon and we are impressed with Organon's 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 face-to-be response 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, sidenafil cream has the potential to be the first. Sidenafil 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 U.S. 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 and Levitra, 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 Sidenafil 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 sobenafil 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 IIb study data showed that sildenafil cream demonstrated statistically significant and meaningful patient improvements. In terms of next steps and what it will take to bring sildenafil cream through Phase III and to a potential approval, well, we had a positive end to Phase II 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, or FSA-D, 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 III, we would anticipate the cost of a Phase III efficacy trial to be comparable to the cost of the Phase IIb 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 three designs and plans, and any relevant updates on our collaboration strategy. In 2023, we also commenced our pivotal phase three study of oviprene, our potentially first in category hormone-free monthly intravaginal contraceptive candidate. In terms of market and revenue potential, we believe oviprene 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 oviprene 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 oviprene has the potential to demonstrate efficacy approaching hormonal birth control methods. There are currently no FDA-approved monthly hormone-free contraceptives, and based on market research, approximately 35 million women in the U.S. are potential candidates for oviprene. We see parallels to NuvaRing when it entered the market as the first monthly intravaginal hormone 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 U.S. commercial rights to Obaprene under a license agreement with us. Under that agreement, we're eligible to receive a $20 million milestone payment at Bayer's sole discretion following the completion of the ongoing Phase III 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 oviprene had the potential to demonstrate typical-use contraceptive effectiveness approaching user-controlled hormonal contraceptives, but without the use of hormones. And in terms of next steps in bringing oviprene toward potential approval, the pivotal study is a multicenter, single-arm, non-comparative Phase III contraceptive study of oviprene 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 this single registration study will be required to support a premarket approval application submission with the FDA. As mentioned by Marty, 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 three 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 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 DARE. Our investigational products are some of the most potentially disruptive candidates for women in decades, and we collaborate with leading companies, including Organon for Zasciato and Bayer for Obaprene, to commercialize and deliver these treatments to as many women as possible. And we do all of this with thoughtful and efficient capital deployment and by leveraging non-dilutive sources of capital wherever feasible. I'd now like to turn the call over to the operator for Q&A.
spk08: Thank you. Thank you for attending the conference call. If you would like to ask a question on the phone lines today, please press star 1 on your telephone keypad. To remove yourself from the queue, it is star 1 again.
spk00: We'll pause for a moment. take our first question from Douglas Tell with HCU Wainwright.
spk02: Hi, good afternoon and 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 Zasciata launch, just given, you know, 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, IQVIA isn't necessarily capturing everything. Thank you.
spk10: 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 sort of the advent of specialty pharmacies, sometimes some of our historic data sources aren't fulsome. as maybe we've gotten accustomed with other products. But what I can say specifically about the Zasciata launch 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, you know, commercial sales milestone commenced in 2023, as Organon put out via 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, if that, in terms of the timing of the product really becoming available. And so, you know, that's why we're looking forward to the year and the activities that are projected for this year. You know, the product, as I mentioned, is in the hands of their Nexplanon Salesforce. You know, 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, and the 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. So, you know, beyond that, you know, we're, 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. you know, and what they have planned and what they're executing on, you know, with the brands this year. And, you know, we're very much looking forward to getting updates as the year continues and particularly as those, you know, royalty revenue dollars show up in our financial statements.
spk02: And Sabrina, maybe as a follow-up, just so Organon made the product fully available nationally in January. I mean, do you know when it sort of, had the full attention of the Nexplanon sales force and do you know the relative position in the reps bags between Nexplanon and Zasciata?
spk10: Yeah, so obviously we can't, you know, comment on, you know, any of the information as you can appreciate might be, you know, proprietary obviously to Organon, but What we can say is that, again, we selected them because of their Nexplanon Salesforce. And part of the beauty of that is that Salesforce only had Nexplanon in their bag prior to Zasciato. And so anyone who's been in a sales situation or a selling situation understands how important it is to have more than one product in the bag, how valued 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 weren't you know, didn't suit their patients maybe as well as they hope and didn't have some of the features that Zasciato does. And so, you know, we really selected Organon because of the attention in the commercial organization that this product would get, 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 Zasciato. But beyond that, in terms of the specifics, I can't add.
spk12: Okay. Thank you so much.
spk09: Absolutely.
spk07: As a reminder, everyone, that is star one to ask a question.
spk08: We'll take our next question from Will Heidel with Brookline Capital Markets.
spk04: Hi, thank you for taking the questions. I just have one quick question. Regarding the other trials, the VVA one, PDM one, HRT one, what is your plan going forward with these trials? Do you have a priority or emphasis on any of them?
spk10: Yeah, no, absolutely. Great questions. And thanks for highlighting some of the other, you know, disruptive products in the portfolio. And so, with all of those other programs, we're really at a stage with those various programs where there's certain, you know, preparatory, I would describe them, activities that are underway. So, for instance, with HRT1, We have had interactions with the FDA. So we have, you know, obviously we've published a number of the outcomes of the two different studies that we run with that product in humans. And we have had interactions with the FDA in order to prepare for an IMD 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 three clinical trial. So we are still undergoing the activities that the FDA has communicated to us that are needed to support that IND. And that's ongoing. So as soon as we have an update on that, we will definitely provide that update. And then that timing will obviously, you know, be important in determining next steps. But the next steps with that program would be after IND submission, its next phase would be to go into a single phase three registration study. And then in terms of VBA1, as I mentioned and as you noted, so 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, you know, identifying clinical sites, protocol preparations, things like that. We don't plan to conduct the Phase II study until after we secure additional capital that would support it, but the next phase for that program would be the Phase II, and as part of our IND process, we got really great feedback from the FDA on the Phase II design so that we could ensure that that would put the product where it needs to be, you know, to advance after that and really leverage kind of this first-in-category opportunity as a non-hormonal product for sexual pain. Okay, thank you. Yeah, absolutely. Yeah, so, you know, doing all we can to get them ready to move forward.
spk04: Yeah, thank you.
spk09: Absolutely.
spk08: 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.
spk10: Well, thank you. Thanks for taking the time this afternoon and the afternoon before the holiday sort of holiday weekend for some. So thank you for taking the time to hear about our recent updates and our ongoing commitment to drive value for all of DARI 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 Zosciato 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 three for our potential first and category treatment options for women with female sexual arousal disorder, our Sudentafil 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 we're well-positioned to accelerate innovation for women in a manner that also drives 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.
spk08: Thank you. And that does conclude today's presentation. Thank you for your participation today, and you may now disconnect.
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