Q4 2023 Dare Bioscience Inc Earnings Call and Business Update
Operator: 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.
Welcome to the conference call hosted by Dar a bioscience to review the company's fourth quarter financial results and to provide a general business update.
This call is being recorded.
Operator: 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-Leighton, Chief Accounting Officer. Ms. Johnson, please proceed. Thank you.
Lisa: My name is Lisa and I will be your operator today.
Speaker Change: With us today from dairy are Sabrina Martucci, Johnson, President and Chief Executive Officer, and Marty hearing Leighton Chief Accounting Officer MS. Johnson. Please proceed.
Speaker Change: Thank you good afternoon, and welcome to the Dar Bioscience financial results and business update call for the year ended December 31st 2023.
Sabrina Martucci Johnson: Good afternoon, and welcome to the Dare 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. Therefore, 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.
Speaker Change: Today, We'll review our financial results for 2023, and discuss developments and expectations for our pipeline and portfolio.
Speaker Change: 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.
Speaker Change: Statements made during this call that are not statements of historical facts should be considered forward looking statements actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties you.
Sabrina Martucci Johnson: 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 28th, 2024. DARI undertakes no obligation to update any forward-looking statements to reflect any information or developments after this call, except as required by law.
Speaker Change: 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.
Speaker Change: I would also like to point out that the content of this call includes time sensitive information that is correct only as of today March 28, 2024 die undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.
Speaker Change: Right.
Sabrina Martucci Johnson: 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.
Speaker Change: As you know women's health is our sole focus at Delray.
Speaker Change: 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.
Sabrina Martucci Johnson: To our knowledge, Dare is the only publicly traded company focused solely on women's health pharmaceutical product development. 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.
Speaker Change: Our knowledge 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.
Speaker Change: Our commitment and focus is to make a difference for women in a relatively efficient timeline by leveraging the basic science and pharmacology that it's 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 it has not previously been applied to the indication in question for women.
Sabrina Martucci Johnson: 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, Dare had 15 interactions with the FDA across six product candidates. Completed the Phase 2B study of our investigational subendothelial cream product for female sexual arousal disorder and the Phase 1 study of our investigational vaginal diclofenac product for menstrual pain.
Speaker Change: 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.
Speaker Change: Many of which have already demonstrated proof of concept.
Speaker Change: And that our robust pipeline of product candidates positions us well for the short medium and long term.
Speaker Change: I'm excited to share today, the strides we made in 2023 to advance innovative therapies for women.
Speaker Change: I'd say, it's on our most promising near term opportunities and the milestones we look forward to in 2024.
Speaker Change: In 2023 alone Dara had 15 interactions with the S T a across six product candidates syndications.
Speaker Change: Completed the phase <unk> study of our investigational suburban fill cream product for female sexual arousal disorder.
Speaker Change: The phase one study of our investigational vaginal diclofenac product for menstrual pain.
Sabrina Martucci Johnson: We received IND clearance for Dare BVA1, our hormone-free candidate for sexual pain, and we commenced the Phase 3 study for our investigational hormone-free monthly contraceptive candidate, Overprotein. 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, Dare was invited to participate in an ARPA Earlier this month, the President called on Congress to make a 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.
Speaker Change: We received IND clearance for Derby D. A one R hormone free candidate for sexual pain, and we commenced the phase III study for our investigational hormone free monthly contraceptive candidate overprint.
Speaker Change: 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.
Speaker Change: As you May know in November of 2023, the White House announced the first ever Whitehouse initiative on women's Health research and effort led by first Lady Dr. Joe Biden, and the White House agenda policy Council to bring together congressional leaders the private sector research institution.
Speaker Change: And so I have to pay to quote fundamentally change, how we approach and fund women's health research.
Speaker Change: In February 2024 yard was invited to participate in an ARPA H I aviation event, where Dr. Joe Biden announced along with ARPA H leadership, the hundred million deployment of capital for women's health.
Speaker Change: Earlier this month, the president called on Congress to make bold transformative investment of 12 billion in new funding for women's Health research.
Speaker Change: 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.
Sabrina Martucci Johnson: 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 and 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 over the 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 Before I do so, I'm going to first turn it over to our Chief Accounting Officer, Marty, to review the 2023 financial results. Thanks, Sabrina.
Speaker Change: 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 bringing financial support for the entire ecosystem to boldly innovate for women.
Speaker Change: Even more of these positive tailwind as can be expected to buoy investor interest and funding in the sector long term.
Speaker Change: Most importantly, we believe our achievements in 2023 demonstrate that our approach to accelerating clinical development works.
Speaker Change: Our leading programs have disruptive potential in the conditions and populations. They aim to treat along with significant revenue potential if approved.
Speaker Change: I'm going to put those 2023 accomplishments and our anticipated 2024 milestones into further perspective, shortly particularly in the contracts in the context of metrics that are important to any current or future shareholder specifically the addressable markets their probability of success.
And why do we would take to advance the programs with a focus on our market on market assets actually auto and our phase III assets overtraining and so that is so crazy.
Speaker Change: Before I do so I'm going to first turn it over to our Chief Accounting Officer, Marty to review the 2023 financial results.
Marty Leighton: Thanks, Sabrina and thanks, everyone for joining us today by way of introduction My name is Marty hearing Layton and I've been at Delray 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 <unk> financial results for the full year 2023.
Marty Herring-Leighton: 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'm excited to be here with you all.
Marty Herring-Leighton: 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.
Marty Leighton: But before I do I would like to put them in context for those of you who are newer to the story.
Berry's business strategy is to assemble and advance our portfolio of differentiated product candidates that address meaningful unmet needs. We have identified and women's health and then monetize the value of our portfolio of clinical and regulatory advances over the near and long term.
Marty Leighton: The investment required to build and advance our portfolio includes corporate overhead portfolio acquisition and maintenance costs and ongoing research and development or R&D expenses.
Marty Herring-Leighton: 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 Zossiato, the first FDA-approved product to emerge from our portfolio, as well as a nominal amount of royalty revenues based on net sales of Zossiato during the fourth quarter. Zossiato 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.
Marty Leighton: 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 our shadow the first FDA approved product to emerge from our portfolio.
Leo as well as the nominal amount of royalty revenues based on net sales of soft shadow during the first fourth quarter saw shadow 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 cost of our phase one and phase <unk> studies of Sildenafil cream our phase.
Marty Herring-Leighton: 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 DARE PDM1 vaginal diclofenac for menstrual cramping, and manufacturing activities as well as preparing for and beginning enrollment in our Phase III study of our intravaginal 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.
Marty Leighton: One study of Dare P. D M. One vaginal diclofenac for muscle cramping and manufacturing activities as well as preparing for and beginning enrollment in our phase III study of our invest intervascular hormone free monthly contraceptive candidate Overbreak.
Marty Leighton: As a reminder, R&D expenses vary from period to period based on our clinical preclinical and 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.
Marty Herring-Leighton: 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 Zashiata 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.
Marty Leighton: Approximately $4 7 million and non dilutive grant funding. We also completed a $7 million registered direct offering in September and a $12 million backed royalty backed investment in December at which we took down $5 million in December the remaining $7 million is available to us to take down through three tranches over time.
Marty Leighton: Dairies auction, the finding the financing structure entitled Investor to a percentage of the royalty and milestone payments to be received by diary under its global license agreement for <unk> with Oregon on only until the Investor achieves a targeted return on investment.
Marty Leighton: As of March 27, 2020 for Dara had approximately 100 million shares of common stock outstanding.
Marty Herring-Leighton: 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 R&D expenditures. In 2024, our only active clinical study at this time is our Phase III Pivotal Overprine 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 Overprine expenses in the 2024 year will be primarily associated with certain manufacturing activities.
Marty Leighton: 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 2020 for G&A expenses to approximately $10 million, which to be clear. It does not reflect 10 million and capital required to fund G&A expenses.
Marty Leighton: Since approximately $3 million of that estimate is estimated accrual based noncash expenses.
Marty Leighton: In addition, as previously noted.
Marty Leighton: 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 are only active clinical study at this time is our phase III pivotal overprint study for which we have already remitted in prior.
Marty Leighton: <unk>, all but half a million of funds due to the NIH under our cooperative research and development agreement and therefore planned overprint expenses in the 2024 year will be primarily associated with certain manufacturing activities.
Marty Herring-Leighton: 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 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, 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.
Marty Leighton: Apart from over Prime related expenses are currently projected 2020 for R&D expenses are primarily carryover slash closeout expenses from the studies completed in 2023, therefore until such time as we commenced an additional late stage clinical study, we anticipate 2020 for R&D expenses to be.
Marty Leighton: Incidentally less than the 2023 R&D expenses.
Marty Leighton: 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.
Marty Leighton: As we have for many of our preclinical programs and these earlier stage programs with grant funding and 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 app.
Marty Leighton: <unk> and build shareholder value.
Marty Leighton: 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.
Marty Herring-Leighton: 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.
We also encourage investors to review the more detailed discussion of our financials and 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. Thank you Don.
Sabrina: 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 there with a focus on our on market assets or shadow and phase III asset.
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 assets, Saciato, and Phase 3 assets, Overpring, and Savanifil Cream. But first, a high-level statement on the R&D spend that Marty just discussed. So, over the last few years, our R&D spend has averaged around $26 million per year.
Sabrina: They have a premium and so then until 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 is averaged around $26 million per year.
Despite the fact that we have typically had multiple ongoing clinical studies in any one year.
Sabrina: 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 and therapeutic categories.
Sabrina Martucci Johnson: Despite the fact that we typically have multiple ongoing clinical studies in any one year, for contact. 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 brand.
Sabrina: This is in part what has contributed to our capital efficient model.
Sabrina: Historically industry wide, we see this trend only 1% of health care investment had gone into women's health and that 1% investment, though has generated 27% of the blockbuster brands.
Sabrina: 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.
Sabrina: So now to transition to our programs in the fourth quarter of 2023, we achieved our first commercial milestone for XI Shadow and now in the first quarter of 2020 for that Shadow is available by prescription across the United States. As a reminder, dashi auto which is clindamycin phosphate vaginal gel is a key.
Sabrina Martucci Johnson: That is reflective of what we believe is the efficiency of the Women's Health Investment Thesis and that we're leveraging in our program. 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, Dashiata, 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.
Sabrina: <unk> 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.
That shadow is indicated for the treatment of bacterial vaginosis and female 12 years of age and older in the United States.
Sabrina: 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 the organon.
Sabrina Martucci Johnson: Tsao 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 the market, I'll focus on what it is 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 it 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.
Sabrina: The prevalence of bacterial vaginosis in the United States is estimated to be 23 million women and as an on market product, thus, Seattle, which represents a non dilutive source of revenue for Dara, we are eligible to receive double digit royalties and up to $180 million in milestone payments from.
Sabrina: Organon.
We look forward to providing that quarterly revenue update that we book as we receive them from Morgan on and we are impressed with organized to go to market strategy that leverages, the knowledge and experience of their established an excellent on commercial team.
Sabrina: And 2023, we also shared positive data from our exploratory phase two b responds study at <unk> cream as a treatment for female sexual arousal disorder.
In terms of end market and revenue potential there are no FDA approved treatment for any form of sexual arousal disorder in women and therefore, <unk> cream has the potential to be the first.
Sabrina Martucci Johnson: In 2023, we also shared positive data from our Exploratory Fair's Safe2Be response study of Sodenafil 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.
Sabrina: <unk> 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.
Sabrina: Symptoms of low or no sexual arousal.
We believe this is a promising untapped market given the numerous equivalent products approved for Madden not only by Agra, but also cialis and <unk> tried to name a few and viagra alone generated $2 billion annually at its peak.
Sabrina Martucci Johnson: 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 and Levitra, to name a few. And Viagra alone generated $2 billion annually at its peak.
Sabrina: In terms of probability of success, we've already demonstrated that that until cream increase genital tissue blood flow in quantitative studies and in the phase <unk> at home study that was specifically designed to identify the patient population that experienced the most meaningful improvement from some benadryl cream.
Sabrina Martucci Johnson: In terms of probability of success, we've already demonstrated that sodenophil 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 sodenophil cream and the questions to ask them that best reflect that improvement so that we could take those forward into phase three 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 two B study data showed that sildenafil cream demonstrated statistically significant and meaningful patient improvement. In terms of next steps and what it will take to bring sildenafil cream through phase three and to a potential approval, well, we had a positive end-of-phase two meeting with the FDA in December of 2023.
Sabrina: And the questions to ask them that does reflect that improvement. So that we can take those forward into the phase III clinical development.
Sabrina: The patient population and the endpoints we have proposed to the FDA are the ones, where our post hoc analyses of the phase <unk> study data showed that <unk> cream demonstrated statistically significant and meaningful patient improvement.
Sabrina: In terms of next steps and what it will take to bring so that it's a cream through phase III and to a potential approval. While we had a positive end of phase two meeting with the FDA in December of 2023 and.
Sabrina: 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 III.
Sabrina: The phase <unk> study with importantly, the first study of its kind and the FDA has indicated they anticipate giving us additional feedback on the phase III design in the second quarter of 2024, we've.
Sabrina: We've already aligned.
Sabrina: That female sexual arousal disorder FSA D is an approvable indication.
Sabrina: As well as the opportunity to perform the efficacy assessment. After just 12 weeks of use.
Sabrina Martucci Johnson: 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 important the first study of its kind, and the FDA has indicated it anticipates 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. 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 it to take forward into phase 3. We would anticipate the cost of a phase 3 efficacy trial to be comparable to the cost of the phase 2b study, so specifically in the $15 million range for each efficacy study.
Sabrina: 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 have identified to take forward into phase III.
Sabrina: We would anticipate the cost of a phase III efficacy trial to be comparable to the cost of the phase <unk> study.
Sabrina: So specifically in the $15 million range for each efficacy study.
Sabrina: We look forward to providing further updates on the FDA discussions the phase III designs and plans and any relevant updates on our collaboration strategy.
Sabrina: In 2023, we also commenced our pivotal phase III study of <unk>, our potentially first in category hormone free monthly <unk> contraceptive candidate.
Sabrina: In terms of market and revenue potential we believe <unk> 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 are those who would prefer not to do so in addition to providing innovation as a hormone free contraceptive.
Sabrina Martucci Johnson: 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 Ovapreen 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 Ovapreen 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 Ovapreen has the potential to demonstrate efficacy comparable to hormonal birth control methods. There are currently no FDA-approved monthly hormonal contraceptives.
Sabrina: The clear differentiation and disruptive potential of overpaying.
Sabrina: It's convenient and potential efficacy.
Sabrina: Its convenience includes easily monthly used in self administration without requiring action at the time the better of course, and we believe <unk> 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.
Sabrina: Research approximately 35 million women in the U S are potential candidates for <unk>.
Sabrina: We see parallels to Nuvaring when it entered the market as the first monthly <unk> contraceptive.
Sabrina: Contraceptive and.
Sabrina: And at peak it generated 900 million in annual revenue.
Sabrina Martucci Johnson: And based on market research, approximately 35 million women in the U.S. are potential candidates for Ovapreen. We see parallels to NuvaRing when it entered the market as the first monthly intravaginal hormone contraceptive, and at its peak, it generated $900 million in annual revenue. Baer is a leader in commercializing contraceptive products in the United States, and they hold the right to obtain U.S. commercial rights to oviprene under a license agreement with us.
There is a leader in commercializing contraceptive products in the United States and they hold the right to obtain U S commercial rights to <unk> under a license agreement with us.
Sabrina: That agreement, we're eligible to receive a $20 million milestone payment at their 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.
Sabrina Martucci Johnson: Under that agreement, we're eligible to receive a $20 million milestone payment at Baer'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 oviparine toward potential approval, the pivotal study is a multi-center, single-arm, non-comparative, phase three contraceptive study of oviparine 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 pre-market approval application with the FDA. As mentioned by Marty, in previous periods, we remitted funds, specifically $5 million, to the NIH to support study activities.
Sabrina: 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 <unk> had the potential to demonstrate typical use contraceptive effectiveness approaching user controlled hormonal contraceptive, but without the use of hormones.
Sabrina: And in terms of next steps in bringing orbit printing toward potential approval.
Sabrina: Pivotal study is a multi center single arm non comparative phase III contraceptive study of <unk> to evaluate its effectiveness as a contraceptive along with its safety and usability over the course of approximately 12 months abuse.
Based on communications to date with the FDA. If successful we believe that just this single registration study will be required to support our pre market approval application submission with the FDA as mentioned by Marty in previous periods, we remitted funds, specifically 5 million to the NIH to <unk>.
Sabrina: Support study activities in.
Sabrina: 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.
Sabrina Martucci Johnson: In addition to that, we are responsible for manufacturing activities and certain external activities, such as the advertising campaign for the study. 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 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 Zasciato and Bayer for Ovaprene, 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.
Sabrina: Since the phase III 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.
Sabrina: So in summary, I'm very excited about the incredible progress we made last year and the promise that 2024 holds for Dara.
Sabrina: Our investigational products or some of the most potentially disruptive candidates for women in decades, and we collaborate with leading companies, including Oregon on <unk> and Bayer for <unk> to commercialize and deliver these treatment to as many women as possible and we do all of this the thoughtful and efficient capital deployment and.
Sabrina: By leveraging non dilutive sources of capital wherever feasible.
None: I'd now like to turn the call over to the operator for Q&A.
Okay.
None: Thank you. Thank you for attending our conference call. If you would like to ask a question on the phone lines. Today. Please press star one on your telephone keypad to remove yourself from the queue. It is star one again.
Operator: Well pause for a moment.
Operator: I'd now like to turn the call over to the operator for Q&A. 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 one on your telephone keypad to remove yourself from the queue. It is star one again.
Operator: We'll take our first question from Douglas Tsao with H C Wainwright.
Douglas Dylan Tsao: Hi, good afternoon. Thanks for taking the question Sabrina I know you are not responsible for commercialization, but.
Douglas Dylan Tsao: Maybe it'd be helpful just to provide a little.
Operator: We'll pause for a moment. We'll take our first question from Douglas Tao, with HCU Wayne-Raymond. Hi, good afternoon.
Douglas Dylan Tsao: Active the exact status of disaster out of launch just given.
Douglas Dylan Tsao: The scripts aren't really necessarily taking off in our scripts fully reflective of whats going on in the market I know you know with some products going through specialty pharmacy to specialty pharmacies.
Sabrina Martucci Johnson: 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 Zasciato launch, just given that the scripts aren't really necessarily taking off and are scripts fully reflective of, you know, what's going on in the market. I know, you know, with some products going through specialty pharmacies, IQVIA isn't necessarily capturing everything. Thank you. Yeah, no, thank you.
None: That isn't necessarily capturing everything thank you.
None: Yeah no. Thank you that's a great question. So first of all yes, absolutely I think as we're all aware with different product brands in different types of launches and so to be advantaged specialty pharmacies and the timing of some of our historic data sources on fulsome.
None: As maybe we've gotten accustomed with other products, but what I can say specifically.
Sabrina Martucci Johnson: That's a great question. So, first of all, yeah, absolutely. I think, as we're all aware of different product brands and different types of launches and the advent of specialty pharmacies, sometimes some of our, you know, historic data sources aren't fulsome, as maybe we've gotten used to with other products. So, what I can say specifically about the Zasciato 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 product availability. Obviously, we're in the 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.
None: About <unk> launch are a few things that obviously has already been said by our commercialization collaborator organon.
None: So first of all while launch activities in terms of US meeting our commercial sales milestone commenced in 2023.
None: As Oregon on put out via press release in January of this year the product became available nationwide in January so thats really when certain activities, obviously commenced in terms of the product availability.
None: Obviously, we're in early days of launch.
None: Just given that we're literally just.
None: Months, and if that in terms of the timing of the product really becoming available and so that's why we're looking forward to the year and the activities that are projected for this year.
None: The product as I mentioned is in the hands of their Nexplanon salesforce.
None: We've previously talked about the reason that we selected working on and they're in their next one on the 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 prescribed and treated bacterial vaginosis is primarily a condition of women.
Sabrina Martucci Johnson: You know, the product, as I mentioned, is in the hands of their Nexplanon sales force. 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 between the provider base that prescribes contraceptives, as well as those that prescribe and treat bacterial vaginosis, which is primarily a condition in 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 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 brand this year.
None: Productive age.
None: And the opportunity for those sales reps to ensure that clinicians and the right providers getting experience with the product.
None: And that the product is available through all of the appropriate channels.
None: So beyond that.
None: I can say very enthusiastically we are very happy with the work that Oregon is doing and the progress that theyre, making with the brand.
None: 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 updates as the year continues and particularly as the royalty revenue dollars show up in our in our financial statements.
None: Okay.
None: And Sabrina maybe as a follow up.
Sabrina: Just to organize data product fully available nationally in January I mean, do you know when it sure does.
Sabrina: Has the full attention.
Sabrina: The next one on sales force and do you know the relative position in the reps back between Nexplanon.
Sabrina Martucci Johnson: 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 statement. And Sabrina, maybe as a follow-up, 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 Zashiata? Yeah, so obviously, we can't, you know, comment on any of the information, which, 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 they only had Nexplanon in their bag prior to Zashiato.
Xactly auto.
Sabrina: Yes, so obviously, we can't comment on any any of the information as you can appreciate might be proprietary obviously to Oregon on budge.
Sabrina: What we can say is that again, we selected them because of their next one on Salesforce and part of the beauty of that is that sales force.
Sabrina: Only half nexplanon in their bag.
Sabrina: Prior to the Shadow.
Sabrina: So anyone who's been in the sales.
Sabrina: Situation or selling situation understand how important it is to have more than one product in the bag how value that value of the black can be how important it is to have something novel.
Sabrina Martucci Johnson: 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, didn't suit their patients maybe as well And so 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 to talk about in terms of Daciato. So beyond that, in terms of the specifics, I can't add anything.
Sabrina: 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 work.
Sabrina: Didn't suit their patients maybe as well as they hope and didn't have some of the features that <unk> does and so we really selected Oregon on because of the attention in the commercial organization that this product would get and particularly that it would be in the hands of our commercial organization.
Sabrina: That really would only have these two products.
Sabrina: To be promoting and obviously nexplanon is a very important brand obviously for organon.
Sabrina: As you've seen in their own numbers.
Sabrina: But this gives that sales organization something novel right to talk about in terms of lost shadow.
None: But beyond that in terms of the specifics I you know I can't I can't add.
None: Thank you so much.
None: Absolutely.
None: As a reminder, everyone that is star one to ask a question. We will take our next question from will <unk> with Brookline capital markets.
Sabrina Martucci Johnson: Okay, thank you so much. Absolutely. As a reminder, everyone, that is star number one to ask a question. We'll take our next question from Will Heidel with Brookline Capital Market. Hi, thank you for taking the questions. I just have one quick question. Regarding the other trials, VVA-1, TDM-1, and HR-2-1, what is your plan going forward with these trials? Do you have a priority or emphasis on any of them? Yeah, no, absolutely not.
Will: Hi, Thank you for taking the questions I just had one quick question.
Will: Regarding the other trials.
Will: PJM ones.
Will: For Q1, what is your plan going forward with these trials do you have a priority or emphasis on any of them.
None: Yeah, no absolutely great questions and thanks for highlighting some of the other.
None: Disruptive products in the portfolio and said with all of those other programs, we're really at a stage with those various programs where there are certain.
Sabrina Martucci Johnson: 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 are certain, you know, preparatory activities, I would describe them as activities that are underway, 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 to get clarity that just the one pivotal study would be required 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 doing the activities that the FDA has communicated to us that are needed to support that IND. And so until we do, 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 be important in determining the next steps.
Preparatory I would describe them activities that are under way.
So for instance, with HR T. One we have had interactions with the FDA. So we have obviously we published.
None: A number of the outcomes of the two different studies that we've run with that product in humans.
None: 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.
None: We are currently conducting the activities necessary to enable the submission of the IND.
None: Application for us so that we can then start that pivotal phase III 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 did and that's ongoing so as soon as we have an update on that we will definitely provide that update.
None: And then that timing will obviously be important in determining next steps, but the next steps with that program would be after IMD submission its next phase.
Sabrina Martucci Johnson: 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 BVA1, as I mentioned, and as you noted, we have the IND application that is cleared and was supported by our phase one, two results that we generated last year. So at this stage, I mean, we're definitely doing activities that would support preparations for moving into a phase two study in terms of, you know, identifying clinical sites, protocol preparations, things like that. We don't plan to conduct the phase two study until after we secure additional capital that would support it, but the next phase for that program would be phase two, and as part of our IND process, we got really great feedback from the FDA on the And I think, absolutely. Yeah. So, you know, doing all we can to get them ready to move forward. Yeah, thank you. Absolutely not.
None: To go into a single phase III.
None: Registration study and then in terms of DVA, one and as I mentioned and as you noted so we have the IND application that is clear.
None: Cleared and was supported by our phase <unk> results that we had.
None: Generated last year.
None: So at this stage I mean, we're definitely doing activities that would support preparations to moving into a phase II study.
None: In terms of identifying clinical sites.
None: Protocol preparations things like that we don't plan to conduct a phase II study until after we secure additional capital that would support it but the next phase of that program would be the phase II and as part of our R&D process. We got really great feedback from the FDA on the phase III design. So that we can ensure that that would put the product.
None: It needs to be.
None: Yeah to advance after that and really leverage kind of this first in category opportunity as a non hormonal product for.
Yes.
None: Your sexual pain.
None: Yes.
None: And I think.
None: Yes.
None: Absolutely Yeah. So you know doing all we can to get them ready to move forward.
None: Thank you.
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. Well, thank you. Thanks for taking the time this afternoon and the afternoon before the holiday, sort of a holiday weekend for some.
Speaker Change: 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.
Speaker Change: 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 a recent updates on our ongoing commitment to drive value for all of <unk> stakeholders by transforming women's health as you heard today, we made important progress in 2023 with our novel.
Sabrina Martucci Johnson: So thank you for taking the time to hear about our recent updates and our ongoing commitment to drive value for all of DARE's 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 quarterly revenue updates on Zosciato as that launch progresses this year, Overcreme 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 Sudenosilcreme program.
Speaker Change: 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 everyday we expect to have numerous 2024 milestones, including the quarterly revenue updates on <unk> as that launch progresses. This year.
Speaker Change: <unk> 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 III for our potential first in category treatment option for women with female sexual arousal disorder, or <unk> program and while not the focus.
Sabrina Martucci Johnson: And while not the focus of today's call, our grant-funded product candidates enhance 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 are well positioned to accelerate innovation for women in a manner that also drives shareholder value.
Speaker Change: Today's call are grant funded product candidates enhance the portfolio and we look forward to providing relevant updates on those ongoing programs as well this year.
Speaker Change: 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 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: We look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you again for your time and your. Thank you. And that does conclude today's presentation. Thank you for your participation today and you may now disconnect, www.dare.gov.uk, ?? ?? ?? ?? ?? ?? ??
None: Thank you and that does conclude todays presentation. Thank you for your participation today and you may now disconnect.
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