5/13/2025

speaker
Operator
Conference Operator

your operator today. With us today from DARE are Sabrina Martucci-Johnson, President and Chief Executive Officer, and Marty Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

speaker
Marty Haring-Layton
Chief Accounting Officer, DARE Bioscience

Good afternoon and welcome to the DARE Bioscience Financial Results and Business Update Call for the quarter-ended March 31, 2025. Today, we will review our results, discuss developments and expectations for our pipeline and portfolio, and discuss our recently announced expanded business strategy, leveraging a dual path strategy where we commercialize our proprietary formulations via 503 compounding, while continuing to seek FDA approval, as well as taking steps toward launching certain solutions as branded consumer health products that do not require a prescription, in all cases to bring solutions to market as soon as practicable. 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 and 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 March 31, 2025, which was filed today, and our Form 10-K for the year ended December 31, 2024. I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 13, 2025. DARE undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law. I will now turn it over to Sabrina.

speaker
Sabrina Martucci-Johnson
President & Chief Executive Officer, DARE Bioscience

Thank you, and thank you everyone for joining the call today. We're excited to announce today that in addition to our proprietary Sudenafil cream formulation, we are taking action to make three more solutions for women available commercially. to vaginal probiotics in 2025, and our proprietary monthly hormone therapy in 2026. Making our hormone therapy solution available next year creates a commercial opportunity for DARE in the estimated up to $4.5 billion compounded hormone therapy market and enables women to have access to an evidence-based solution. As you can appreciate, four on-market products will accelerate revenue generation and and provide a path to profitability. We expect to start recording revenue in the fourth quarter of this year. Anyone following the healthcare and biotech sectors knows that the first quarter of 2025 has been marked by distractions and disruptions for the overall healthcare and biotech sector. I'm proud that DARE is uniquely positioned to cut through the noise and deliver value to all of our shareholders, women, healthcare providers, and investors who are all stakeholders in DARE. Today, biopharmaceutical companies with relatively low-risk assets, a competitive advantage, and a path toward near-term revenue are positioned to offer upside. We believe that is DARE today. Women's health is ripe for returns because it has been underfunded and fragmented. And with our recently announced expanded business strategy, we believe we are strongly positioned to deliver value and returns to all of our stakeholders with a business model that is nimble, allowing us to rapidly commercialize multiple products via multiple channels. We're no longer only seeking FDA approval. We're leveraging a dual path strategy where we commercialize via 503 compounding while continuing to seek FDA approval. We're also taking steps towards launching certain solutions as branded consumer health products that do not require a prescription. At DARI, women's health isn't just a priority. It's our sole purpose. And to our knowledge, we are the only publicly traded company focused solely on developing therapeutic products for a broad range of conditions affecting women. Contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health, and menopause. And to our knowledge, we're the only publicly traded company leveraging all available paths to bring evidence-based solutions to market, reflecting where and how women are getting and paying for their care. As an FDA-approved treatment, as a compounded product, as a consumer health product that does not require a prescription, available via telehealth, online, or via an in-person visit with her healthcare provider. Our portfolio is compelling. And over the last months and the next months, we look forward to continuing to provide updates regarding strategic partnerships and collaborations to facilitate access to DARE on market brands for women across multiple channels. Today, I'll provide some perspective on these channels and the strategic relationships we're seeking to enter into to provide women with access to our evidence-based solutions from their trusted sources. where they get their medication, and their healthcare solutions. I'll also provide a refresher on our potential first in category monthly intravaginal hormone therapy, a product candidate we've been developing to really shift the hormone therapy landscape. Gaps in solutions for menopause symptoms have given rise to an explosion of untested supplements and therapies. We believe in delivering hormone therapy that has been rigorously studied to meet the needs of women and their doctors. Please keep in mind that bringing our proprietary Sedentafil cream formulation and our monthly intravaginal hormone therapy solution to market via 503B compounding will not impact the regulatory process or commercial opportunity for an FDA-approved product. Rather, if successful, it accelerates the availability of these proprietary formulations for healthcare providers and women, and it accelerates revenue. It can also provide real world evidence and experience that we would seek to utilize to streamline the path to an FDA approval of these potential first in category candidates. I'll also give some background on the vaginal probiotics that we also intend to bring to market this year. Both of which, by the way, were identified via a grant we received from the Gates Foundation to evaluate the global probiotic manufacturer community and identify evidence-based formulations from manufacturers following GMP. I'll also give a brief update on Oviprene, our novel investigational hormone-free monthly intravaginal contraceptive, the ongoing enrollment in the pivotal phase three contraceptive efficacy study, and our data safety monitoring board interim assessment, which is scheduled for July of this year. as well as other therapeutic development pipeline updates on Sidenafil and DARE-HPV, which is our investigational product for the treatment of human papillomavirus infection, which is the virus that causes cervical cancer. Before I provide additional updates, I'm going to first turn it back over to our Chief Accounting Officer, Marty, to review first quarter 2025 financial results.

Disclaimer

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