Dare Bioscience, Inc. Common Stock 2026 Q2 Earnings Call

Today, we will review our financial results, provide updates on our commercial products and clinical pipeline, and discuss the continued execution of our expanded business strategy. That strategy includes a dual-path approach, commercializing proprietary formulations through 503B compounding while pursuing FDA approval and advancing select solutions as branded consumer health products that do not require a prescription. In all cases, our goal is to bring innovative women's health solutions to market as efficiently and quickly as possible. 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 actual statements of historical fact should be considered forward-looking statements.

Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our quarterly report on Form 10-Q for the quarter ended June 30, 2026, which was filed today, and our annual report on Form 10-K for the year ended December 31, 2025. Please note that the content of this call includes time-sensitive information that is current only as of today, August 13, 2026. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

I would also like to point out that when we use the term 503B compounding during this discussion, we are referring to compounding drug products by outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act using bulk drug substances on the FDA's interim Category 1 list. I would now like to turn the call over to Sabrina.

Thank you, Marnie, and good afternoon, everyone, and thank you for joining us. For more than 10 years, Daré has been building towards this moment. We built Daré on a simple conviction. Women's health is an investment-grade category, not a niche, not a side project. A category worth building, funding, and holding accountable for delivering the healthcare options women deserve. Every asset we developed, every trial we ran, every grant we secured, every collaboration we've negotiated, all of it has been directed towards this one purpose, closing the gap between promising science and real-world solutions for women. Over the past few months, that strategy crossed an important threshold. We did not stop being a science-driven development company. We added something new, commercial execution.

Even modest penetration could generate significant commercial value, particularly when considering the potential for repeat use. Flora Sync LF5 was priced with accessibility and ongoing use in mind. We believe it has potential to become part of a woman's regular vaginal care routine, creating an opportunity to drive initial trial, encourage recurring demand, and build lasting consumer relationships. Let me now turn to DARE to PLAY sildenafil cream, our proprietary topical sildenafil cream designed for women, which addresses a large and deeply underserved area of women's health. An estimated 20 million women in the U.S. experience symptoms of low or no sexual arousal. Yet there is no currently FDA-approved treatment specifically indicated for female sexual arousal disorder.

Women have waited far too long for solutions developed around their physiology, experiences, and needs. In clinical studies of our formulation, we observed increased genital blood flow and improvements in arousal sensations. The formulation was well-tolerated by both users and their partners in our phase IIb study, and no serious safety concerns were reported. By improving physical arousal sensation, DARE to PLAY sildenafil cream is designed to support a more positive and responsive sexual experience. At a price of $99 per tube, which provides for about 10 uses, the estimated addressable population of 20 million women represents a total market opportunity of approximately $2 billion. Even modest market penetration could create meaningful commercial value in an area with limited female-specific treatment options.

Initially, we intended to make DARE to PLAY sildenafil cream available by prescription as a 503B compounded product while continuing to pursue the 505(b)(2) regulatory pathway toward potential FDA approval. You might ask, why the dual-path regulatory strategy? The reason is that while the compounded pathway offers a capital-efficient way to enter the market, FDA approval would represent an opportunity for women to have an FDA-approved option, as men do. An FDA-approved product could provide greater confidence among patients and prescribers and support broader commercial adoption because FDA-approved products can be administered as treatments and considered for coverage by payers. It could also strengthen our competitive position to create a more durable and valuable commercial franchise.

In this way, the compounded product can provide an efficient path to early market entry while pursuing FDA approval is designed to unlock the potential of the product as the potential first FDA-approved product to treat female sexual arousal disorder. Although DARE to PLAY sildenafil cream is not yet dispensing, interested customers can already begin the simple process of obtaining a prescription. While it's still early, I'm encouraged by what we're seeing in terms of geography of prescriptions being written, a healthy split between office providers and telehealth, and repeat prescriptions from providers. Dispensing is targeted to begin this quarter. Let's now turn to our commercial strategy. It begins with providers. OBGYNs and women's health specialists are trusted voices, and their conviction can drive both product awareness and appropriate patient use.

Digital marketing expands that reach by educating women directly and helping us identify the messages and audience that converts most efficiently. Telehealth creates convenient access and national reach, and the DARE Health Hub brings education, product access, fulfillment, and ongoing engagement into one central destination. Our recently announced collaboration with MyMenopauseRx further expands that ecosystem through an established women's health telehealth platform. Additionally, this collaboration highlights how we plan to engage with other telehealth platforms, where women can receive a prescription for DARE to PLAY sildenafil cream. The DARE Health Hub serves as the foundation of our commercial strategy. For patients, the DARE Health Hub creates a central destination where women can learn about our products, understand which solutions may be relevant to their needs, and navigate the path to access.