Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2023 Earnings Call Transcript

Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2023 Earnings Call Transcript August 10, 2023

Daré Bioscience, Inc. reports earnings inline with expectations. Reported EPS is $-0.1 EPS, expectations were $-0.1.

Operator: Welcome to the conference hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30, 2023, and to provide a General Business Update. This call is being recorded. My name is Mark and I will be your operator today. With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Commercial Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer. Ms. Johnson, please proceed.

Sabrina Martucci Johnson: Thank you. Good afternoon, and welcome to the financial results and business update call for the quarter ended June 30, 2023 for Daré Bioscience. For those of you joining us via webcast, you should be able to access presentation slides from within the webcast module. We’ve included the slides to provide some additional context on our portfolio that you may find helpful while you listen to the call. The slide deck is also available in the Investor Relations section of our website under Presentations, Events and Webcast and will remain on the site for two weeks. Today we will review our second quarter results, and discuss developments and expectations for XACIATO commercialization and for two of our late-stage investigational products, our hormone-free monthly, intravaginal contraceptive candidate Ovaprene and Sildenafil Cream 3.6% which is being developed as a treatment for arousal disorder in women.

Before we begin, I would like to remind you that today’s discussion will include forward-looking statements within the meaning of federal securities laws which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical 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 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-Q for the quarter ended June 30, 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, August 10, 2023. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. As a reminder, at Daré Women’s health is our sole focus. We believe that innovation in women’s health needs to be a priority and we believe investment in women’s health would be efficient and disproportionately impactful. Given that women control 80% of US healthcare purchasing decisions and that although only 1% of healthcare research dollars are invested in women’s health, women’s health products nonetheless makeup 27% of total products generating over $500 million in revenue annually and contribute to 35% of total blockbuster sales.

We are working to identify and advance new therapies that provide additional choices and improve outcomes so that we can make a difference in the lives of women everywhere. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health and fertility. Our portfolio includes one, FDA-approved product which is being commercially launched by Organon and five clinical development-stage candidates, three of which are in or nearing phase 3 development. Today, I will provide development updates on two of the late-stage candidates Ovaprene and Sildenafil Cream; John will provide an update on XACIATO and Lisa will review our financial results for the quarter ended June 30th. So let’s start with Sildenafil Cream.

Sildenafil Cream is our investigational candidate to treat sexual arousal disorder in women. Arousal disorder in women is characterized by the inability to achieve a sufficient physical response to sexual stimulation that causes clinically significant distress and at the various types of female sexual dysfunction disorders arousal disorder in women is most analogous to erectile dysfunction or ED in men. Sildenafil, which is a phosphodiesterase five inhibitor is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of ED in men. Sildenafil Cream is an investigational proprietary topical cream formulation of Sildenafil, specifically designed to be used on-demand at the time of sexual activity to increase blood flow to the genital issue of women.

If development is successful, Sildenafil Cream has the potential to be the first FDA-approved product to treat any form of arousal disorder in women. Market research suggests that 16% of women in the U.S. ages 21 to 60 or approximately 10 million women are distressed from experiencing no or low sexual arousal and are actively seeking solutions to improve their condition. In comparison, the prevalence of complete ED in men is estimated to be about 5% as men at age 40 increasing to about 15% at age 70. Women who experience no or low sexual arousal are bothered by and/or are dissatisfied with their sex lives, they’re frustrated with her sexual problem, they experience guilt about their sexual difficulties and they are likely to feel sexually inadequate, inferior and embarrassed.

Sound familiar, like what men with erectile dysfunction experience as men did before effective ED treatments, women are suffering in silence and are affected by a feeling of shame and embarrassment. We are working to change this for women by developing a treatment that can address their lack of physical arousal response, which we believe in turn will improve their sexual interest and reduce dissatisfaction with their sex lives as the effective ED treatments did for men. On June 5th, we reported top-line results of the exploratory phase to be RESPOND clinical study of Sildenafil Cream and on July 11th we reported additional positive data from the study and hosted a webinar with KOLs or key opinion leaders to further discuss the findings from the study.

For those of you who missed those updates, I want to take a moment today to highlight some of the key results and outcomes of the Phase 2b RESPOND study and the implications for future development. Now, the purpose of the exploratory Phase 2b RESPOND study was to test the sensitivity of several patient-reported outcomes also referred to as PRO efficacy endpoints and their ability to determine a treatment effect of Sildenafil Cream compared to placebo to inform the ongoing development of Sildenafil Cream. This study also served as a validation study of exploratory endpoints that could be candidate efficacy endpoints in a Phase 3, study of Sildenafil Cream. Because there are no currently FDA approved treatments for any form of arousal disorder in women there are no efficacy endpoints that have been previously approved for use in a Phase 3 pivotal study for potential treatment of those disorders.

Photo by National Cancer Institute on Unsplash

In the Phase 2b study, the Sildenafil Cream treated group showed improvements in multiple aspects of the sexual experience, including arousal, lubrication, achievement, and pleasure of orgasm, and sexual desire. The data indicates that as compared to placebo Sildenafil Cream had a therapeutic effect based on several of the exploratory PROs. The data from the Phase 2B RESPOND study we believe, certain of the primary secondary and exploratory endpoints based on that study could be candidate endpoints in a Phase 3 study of Sildenafil Cream. Having now completed this pioneering work in the field of arousal disorder in women, we look forward to reviewing the data with the FDA including discussing the data from assessments as early as the four and eight week mark after randomization and continuing the development of Sildenafil Cream including our objective of initiating the first-ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women.

It is our belief that a candidate that can successfully address the significant unmet need of arousal disorder in women represents one of the largest opportunities in women’s health today. We therefore believe that Sildenafil Cream represents a promising clinical candidate in a meaningful valuation driver for our company. Sildenafil Cream has the potential to be the first FDA approved product to treat any form of arousal disorder in women. And we remain committed to working with our development partner SST and the FDA to move this candidate forward. We are continuing to analyze the data from the Phase 2b RESPOND study, and are targeting and end of Phase 2 meeting with the FDA before the end of this year, before the end of 2023, which if successful, would support Phase 3 commencement in early 2024.

Following clinical development, which we expect will include two pivotal Phase 2 studies, we intend to leverage the existing safety and efficacy data on the active ingredient in Sildenafil Cream to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval in the U.S. We look forward to keeping you updated on this program, particularly as we collaborate with the FDA on the Phase 3 program. Now I’d like to turn to Ovaprene. Ovaprene is our investigational, potentially first in category hormone-free monthly intravaginal contraceptive. There truly is nothing like it on the market today. while a monthly hormone containing vaginal ring product has been available for several years, NuvaRing peak sales reached nearly a billion dollars, there is no hormone-free counterpart with a similar monthly intravaginal dosing format.

We have been working closely with our Phase 3 collaborator NICHD of the NIH on the pivotal study plan to start later this year. Specifically, the pivotal Phase 3 study of Ovaprene is being supported by the NICHD’s contraceptive development program, which oversees the Contraceptive Clinical Trials Network, or CCTN established in 1996 to conduct studies of investigational contraceptives. We expect to commence subject to enrollment in the fourth quarter of this year. This study is a multicenter, single-arm, non comparative pivotal Phase 3 contraceptive study of Ovaprene to evaluate its effectiveness as a contraceptive device, along with its safety and usability. Based on our communications with the FDA, if successful this will be the single registration study required to support the pre-market approval, application submission with the FDA.

Now a few details on the study. This is a non-comparative study meaning all women will use over Preen. There is no placebo in this study. We will target having approximately 250 subjects, complete 12 months, that’s 13 menstrual cycles of use. Based on typical dropout rates for contraceptive studies, we will look to enroll more than double of our target number of completers. Once enrollment is well underway and we have a clear sense of dropout rates in this study, we will be able to provide guidance on when to expect study completion. The primary objective of the study is to assess pregnancy rates over 13 cycles. Primary endpoint will be using a pearl index typical use pearl index this is the common primary endpoint for contraceptive product candidates.

Secondary objectives are looking at the contraceptive effectiveness on a typical use pregnancy probability basis within 13 cycles, as well as safety and acceptability. We recognize that while much work had been done over the last 20 years to improve hormonal contraception, efforts to innovate non-hormonal options have lagged. And therefore, we believe that Ovaprene has the potential to be a disruptive product in the contraceptive category as NuvaRing was when it entered the market as the first monthly intravaginal contraceptive delivering hormones and as Mirena did, when it entered the market as the first hormone releasing intrauterine system. Speaking of Mirena, they are a leader in commercializing contraceptive products in the United States, holds the US commercial rights to Ovaprene, under a license agreement with us.

I will now turn it over to John to provide a commercial update on the XACIATO launch activities, as well as on commercial preparedness activities for our development candidates Ovaprene and Sildenafil Cream.

John Fair: Thank you, Sabrina. As a reminder, XACIATO clindamycin phosphate vaginal gel is lincosamide antibacterial for single dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients, 12 years of age and older in the United States. Organon, our global commercial collaborator believes there’s roughly a 90% overlap of healthcare providers who prescribe their contraceptive product NEXPLANON and have the potential to be prescribers of XACIATO, based on provider treatment patterns. Because of these strong relationships, the Organon sales team has with these healthcare providers, we expect Organon to be well-positioned to detail XACIATO and drive product prescriptions and pullthrough on day one of launch.

We believe that XACIATO should be well-positioned for commercial success, given the knowledge and experience of Organon’s Nexplanon sales team, coupled with their planned marketing and payer outreach initiatives as we have outlined on previous calls and we plan to provide further updates once the product is on the market. Organon and Daré are working towards a US launch as soon as feasible. Looking ahead to our later-stage programs, in parallel with the Ovaprene Phase 3 study activities, our team has been busy working with our collaborator Bayer on key commercial initiatives to ensure a seamless transition from clinical development to commercial introduction. We have organized a cross-functional team to align and activate on key aspects of the brand, including packaging, messaging and key opinion leader targeting.

These activities will help set the foundation for additional downstream, post-approval sales and marketing activities. And finally, we are truly excited about the progress on the Sildenafil Cream program. As we continue to analyze the data we are planning to implement a robust medical communication strategy to make sure we are educating all of the key stakeholders in women’s health and sexual health on key aspects of the condition, including pathophysiology and quality of life issues and plan to work with our colleagues on the medical side to ensure broad dissemination of this information. We will have more information on these initiatives moving forward, but we remain very excited about the opportunity to bring forward a first in category solution like Sildenafil Cream that has the potential to improve the lives of millions of women dealing with sexual disorder and bring a much-needed new option for providers that currently have nothing to prescribe them.

With that. I will turn the call over to Lisa.

Lisa Walters-Hoffert: Thank you, John. And thanks for all of you for joining today. I would now like to summarize Daré’s financial results for the quarter ended June 30th 2023, which I will refer to as the current quarter or the second quarter. As, you know, Daré’s business model is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet means that we’ve identified in women’s health and then to monetize the value of the portfolio’s clinical and regulatory advantage 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 the second quarter, our general and administrative or G&A expenses were approximately $2.9 million. Our R&D expenses, which vary from period-to-period based on our clinical, preclinical, manufacturing, regulatory and other activities across our entire portfolio were approximately $6 million and primarily reflected the cost associated with the Sildenafil Cream Phase,2b RESPOND clinical trial that Sabrina just summarized and manufacturing and regulatory affairs activities related to Ovaprene’s planned Phase 3 study. Our comprehensive loss for the current quarter was approximately $8.7 million. We ended the current quarter with approximately $13.3 million in cash and cash equivalents. And as of August 9th 2023, we had approximately 87.8 million shares of common stock outstanding.

Under our license agreement with Organon for XACIATO, we received $1 million in July and we are entitled to receive $1.8 million following the first commercial sale. Thereafter, we will be eligible to receive potential additional milestone payments of up to $180 million, as well as tiered, double-digit royalties based on XACIATO’s net sales. We are continuing to explore a variety of options to fund our operations and advance our candidates, monetize the value of our assets and build shareholder value. These alternatives include, but are not limited to non-dilutive grants like the one we recently received from the NIH for a preclinical candidate, equity sales, license agreement, structured financings, and strategic collaborations or alliances.

As we said previously, we will endeavor to be creative, collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value. We encourage all investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, risk factors in the Form 10-Q for the quarter ended June 30th 2023, which we filed today, and in our Annual Report on form 10-K for the year ended December 31st 2022, which was filed on March 30th 2023. I would now like to turn the call over to the operator.

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Q&A Session

Operator: Thank you for attending the conference call. [Operator Instructions] Our first question comes from the line of Catherine Novack with Jones Research. Catherine, the line is now open.

Catherine Novack : Hi. Good afternoon. Thanks for taking my question. I guess just, a couple questions on Ovaprene. Can you remind us what’s still gating to the initiation of the study? And what are some key inclusion exclusion criteria that you are anticipating that might affect the screen rate and enrollment rate of the study?

Sabrina Martucci Johnson : Yeah, great questions. And thanks for your questions as always. In terms of what’s gating the start of the study, we’re really gearing up to be ready to go. So, as I’ve mentioned in my comments today, we’re working with the NIH, the NICHD on the conduct of the study and they actually held an investigator meeting with the investigators who identified for the Ovaprene study actually last December. So these investigators are been excited in prime for a while. You may recall, there were some comments from the FDA when we got our IDE approval to move forward with the study with some recommendations on some tweaks around considerations around the protocol that they encouraged us to make to ensure that it would meet all their expectations.

And so we have done that. And then we’ve been getting the sites kind of reoriented to the protocol and ready to go. And so, we’re really preparing to initiate enrollment now in the fourth quarter. And then, obviously, we’ve been manufacturing with our partner to prepare for that. So, we’re super excited to get started obviously, and all the pieces are coming together and are on track right now for that. In terms of and all the sites as I mentioned, there’s a clinical trial, their networks – the Contraceptive Clinical Trial Network sites that are participating in this study. So it’s about 20 sites right now that are participating in the study. And so they are, they’re almost set up. In terms of the key in kind of inclusion exclusion criteria, it’s pretty standard for a contraceptive study.

So patients have to be a certain age. They have to be in a committed partnership. They have to have a commitment to have certain number of sexual events every month. So they can’t have certain medical conditions that would be pretty standard in a contraceptive study to be exclusionary. So there’s nothing really unique in terms of the inclusion and exclusion criteria for this study. What we do see there was contraceptive studies that as we’ve looked across a number of this contraceptive studies that have been conducted over the years and that’s one of the nice things about working with the NIH and the Contraceptive Clinical Trial Network is that we get the benefit of a lot of other studies they’ve done for their sponsors and products. What we’ve seen is that, the difference we’ve seen kind of meaningful frankly differences in dropout rates and screening rates across different contraceptive studies.

And those all can obviously impact kind of your timelines and enrollment. And that’s one of the reasons that I stated in my comments. We want to get our particular study going in this particular day and age right in this environment and then get a sense of what those metrics look like. And then that’ll allow us to give kind of strong predictions on occasions when we expect the study to complete. But in terms of initiating the movement, we’re targeting that for the fourth quarter and are very much looking forward to getting started. So hopefully that answered your questions.

Catherine Novack : No. That was very helpful. Just curious, if you can talk about the expected geographic spread of the 20 sites and I’m curious what you’re seeing in terms of enrollment dynamic based on, I guess, you would say the political environment.

Sabrina Martucci Johnson : Yeah, I go to Seattle.

Catherine Novack : Right. And what’s the level of interest across different areas of the U.S.?

Sabrina Martucci Johnson : Yeah. Fantastic question. So the sites are spread across the country. So, pretty, good diversity across the country in terms of where the sites are. And that also means there’s some diversity in terms of kind of what the reproductive right landscape is in a particular state, where that site is. What we’ve seen across the board and these are investigators that have all participated in lots of contraceptive studies and are very experienced in that regard, their view is that obviously, it’s a factor, right? It’s something that people are considering and certainly people that are signing up for a contraceptive study, by definition they have to be open to the fact that they may get pregnant right? It’s an investigational product.

And so they have to be aware that that is a factor. And where they reside that may be more meaningful to them than maybe in a different state in terms of what their propensity and comfort with that is. But all of the sites feel that, none of them have really projected that it would change how they anticipate enrollment progressing. Because their view is that it’s always a consideration anyhow and then, in general people who tend to participate in contraceptive studies generally have a good acceptance of the fact that they may get pregnant and are prepared for that outcome. But it’s definitely something that has been [Aidio Gap] Sort of the cost providing the Ovaprene supplies for the study. And then, the way the creative works is Daré puts funds into basically to the NIH basically into an account for use in the study.

So we have contributed our $5 million today to that account. There’s another $500,000 that we would anticipate right now providing this year to support the study, as well. And those funds should be sufficient. However, clinical trial costs can vary, right, as you’ve said as progress things happen, right? Or if we add additional sites so there are a number of factors that could change the cost of the study. And so if that happens, then we and the NIH would come together and decide what our contribution would be, what their contribution would be if that were to happen and adjust accordingly. But right now, like we’ve put our monies there and those are the funds along with support from the NIH to conduct the study.

Catherine Novack : Okay, that’s very helpful. Thanks for taking my questions. Have a great afternoon.

Sabrina Martucci Johnson : Yeah. Thank you.

Operator: [Operator Instructions] Your next question comes from the line of Michael Elsa – Michael. I’m sorry, but I think we lost Michael. Okay. So there are no further questions at this time, I would like to turn the call back over to our presenters.

Sabrina Martucci Johnson : Alright. Well, thank you for taking the time this afternoon to hear about our recent updates and ongoing commitment to drive value for Daré stakeholders, women, health care providers, and our shareholders. With our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women’s health and well-being expand treatment options where none exists, enhance outcomes where current standard-of-care has meaningful shortcomings and improve ease of use for women, where a more compelling form factor can drive adoption, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. We definitely look forward to keeping you updated on our progress towards the milestones we discussed today.

Specifically, our XACIATO product launch and first commercial sale by Organon. As John mentioned, we are working together to achieve a 2023 launch as soon as feasible. Patient enrollment in the Phase 3 clinical study of Ovaprene, our investigational potential first in category, hormone-free monthly intravaginal contraceptive, whose US commercial rights are under the license agreement with Bayer. And as we just discussed, we expect that single pivotal study to support Ovaprene’s pre-market, approval application and enrollment is targeted to commence this fourth quarter of this year. We’re also looking forward to our end of Phase 2 meeting with the FDA and finalization of a Phase 3 protocol for the next Sildenafil Cream study. In addition, we look forward to announcing data later this year from our Phase 1 study evaluating a vaginal gel formulation of Aceclofenac being developed as a treatment for menstrual pain and cramps, as well as ongoing activities related to IND and Phase 3 and Phase 2, preparations for our two menopause programs, hormone therapy for the vasomotor symptoms of menopause and hormone free vulvovaginal atrophy treatment respectively.

So with that, I thank you again for your time today and for your support. Thank you.

Operator: This concludes today’s conference call. You may now disconnect.