Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2025 Earnings Call Transcript

Daré Bioscience, Inc. (NASDAQ:DARE) Q2 2025 Earnings Call Transcript August 14, 2025

Daré Bioscience, Inc. beats earnings expectations. Reported EPS is $-0.45, expectations were $-0.55.

Operator: Welcome to the conference call hosted by Daré Bioscience Therapeutics Company’s Second Quarter 2025 Financial Results and to provide a business update. This call is being recorded. My name is [ Jericho, ] and I will be your operator today. With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. Haring-Layton, please proceed.

MarDee J. Haring-Layton: Good afternoon, and welcome to Daré Bioscience Financial Results and Business Update Call for the quarter ended June 30, 2025. Today, we will review our financial results, provide updates on our 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 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, 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, August 14, 2025.

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 will now turn it over to Sabrina.

Sabrina Martucci Johnson: Thank you, MarDee, and thank you to everyone joining us today. Daré is at an inflection point. The second quarter of 2025 reflects the continued acceleration of our dual-path strategy as we focus on closing the gap in women’s health between promising science and real solutions, generating near-term commercial revenue while advancing long-term innovation in women’s health. We remain on track to support the commercial availability of DARE to PLAY Sildenafil cream through a 503B outsourcing facility in the fourth quarter of this year. This anticipated launch represents a major milestone not just for Daré, but for the field of women’s sexual health, where innovation has historically lagged behind other therapeutic areas.

Q&A Session

At the same time, we continue to advance our differentiated clinical pipeline, which includes primarily grant-funded programs, targeting areas of significant unmet need, including contraception, HPV and preterm birth. We believe this dual-path approach enables us to unlock value efficiently by leveraging nondilutive capital and a disciplined investment strategy. Let me walk you through several highlights across our portfolio. First, DARE to PLAY Sildenafil cream, a near-term revenue opportunity. We remain on track to support a fourth quarter 2025 launch. [Technical Difficulty]

MarDee J. Haring-Layton: I’m going to jump in here because we’re having some technical difficulties. As Sabrina said, we remain on track to support a Q4 2025 launch of DARE to PLAY via a 503B outsourcing facility. This channel allows us to accelerate patient access to our proprietary formula while discussions with the FDA continue on defining acceptable endpoints for a future FDA registration path. In partnership with Rosy Wellness, we launched the first phase of our direct-to-patient awareness campaign. Feedback from this early effort reinforces the significant interest and unmet need in supporting women with arousal concerns. On August 6, Daré hosted a provider-oriented webinar titled the DARE to PLAY Difference, The Sildenafil Cream That Raises the Bar in partnership with the National Association of Nurse Practitioners in Women’s Health.

This session featured renowned experts, Dr. Irwin Goldstein, Founding Editor of the Journal of Sexual Medicine; Sue Goldstein, former President of the International Society for the Study of Women’s Sexual Health and Certified Sexual Educator; and Rose Hartzell-Cushanick, an AASECT-certified Sex Therapist. The discussion explored DARE to PLAY’s formulation science, clinical evidence showing improved genital blood flow and arousal outcomes and critical clinician insights on why DARE to PLAY Sildenafil cream would set a new standard in women’s arousal — women’s sexual arousal health care. The replay is available at daretoplaybio.com. This is a large under-recognized market where the promise of Sildenafil, the same active ingredient in an oral erectile dysfunction drug, is recognized, but the clinical evaluation of topical Sildenafil formulations has been lacking.

We, therefore, believe DARE to PLAY Sildenafil cream is positioned to be the first meaningful prescription innovation in this category. We are excited about its potential as a near-term revenue driver. Please visit www.daretoplaybio.com for updates and access alerts so that you can be among the first to know when the only evidence-based Sildenafil cream formulation DARE to PLAY Sildenafil cream becomes available. Next on to Ovaprene Phase III trial update. Turning to Ovaprene, our first — our potential first-in-category, hormone-free monthly contraceptive candidate. We announced this quarter that the independent Data and Safety Monitoring Board, or DSMB, reviewed interim data from the Phase III study and recommended that the trial continue as planned.

There were no new safety or tolerability concerns or serious safety concerns identified, and the interim pregnancy rate of women treated in the study was consistent with our expectations based on our prior postcoital test study of Ovaprene. These data support Ovaprene’s potential to fill a significant gap in the contraception landscape, providing women with a nonhormonal user-controlled option without daily intervention. With millions of women in the U.S. seeking effective hormone-free birth control, Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape. We look forward to the completion of the study and the final analysis of study endpoints, including the primary endpoint of pregnancy rate calculated using the Pearl Index.

Recall that Bayer received the right to obtain exclusive U.S. rights to commercialize the product following completion of the pivotal clinical trial if Bayer in its sole discretion, makes a $20 million payment to Daré. Daré may receive up to $310 million in commercial milestone payments, plus double-digit tiered royalties on net sales. The potential $20 million payment and royalty payments are subject to a third party’s minority interest under royalty purchase agreement entered into in April 2024. Next, DARE-HRT1 dual commercialization pathway. We are also excited to update you on DARE-HRT1, our proprietary intravaginal ring designed to deliver bio-identical estradiol and progesterone for monthly hormone therapy. We are pursuing both a traditional FDA approval path and a 503B compounding opportunity similar to our dual-path strategy for Sildenafil cream.

We believe this approach allows us to accelerate patient access while continuing to generate the data necessary to seek FDA approval and support long-term value creation. DARE-HRT1 will be a unique solution in the estimated $4.5 billion compounded hormone therapy market, and we believe it could generate meaningful revenue alongside DARE to PLAY Sildenafil cream. We are targeting its availability via a 503B outsourcing facility in late 2026. Next, vaginal probiotics represent our consumer health expansion. In parallel with our prescription portfolio, we are preparing to launch two nonprescription vaginal probiotics designed to support vaginal microbiome health. At Daré, we believe women deserve access to the highest quality evidence-based products.

Our goal is simple: to bridge the innovation gap and ensure that women have access to the tools to support their intimate health. To that end, we seek to leverage innovative science-backed vaginal health approaches developed in Europe and already being used by women in countries where they are available. We look forward to bringing those products to women in the United States. These products will complement our prescription offerings and represent an important diversification of our commercial platform. We anticipate introducing them following the launch of DARE to PLAY, so please stay tuned to learn more later this year. Grant-funded clinical programs, innovation through efficiency. We continue to advance programs supported entirely by nondilutive funding awards.

DARE-HPV is in development as a novel intravaginal therapy for persistent high-risk HPV infection. The program is currently funded through an ARPA-H award and NIH grant. DARE-LARC1 is a preclinical stage long-acting contraceptive intended to offer multiyear protection with remote pause/resume control. A $6 million grant installment was received just last month. These programs target significant unmet needs and further differentiate our pipeline in women’s health. And now on to review the financial results for the recently completed quarter. I’d now like to summarize Daré’s financial results for the quarter ended June 30, 2025, which I will refer to as the second quarter. We ended the quarter with approximately $5 million in cash and cash equivalents, and working capital deficit of approximately $12.6 million.

After quarter end, we received approximately $17.6 million in net proceeds from sales of our common stock and a $6 million grant payment. This additional capital significantly strengthens our balance sheet, enhancing our ability to execute on our dual-path strategy. G&A expenses were $2.4 million compared to $2.5 million in Q2 2024. The year-over-year change was primarily due to decreases in personnel costs, stock-based compensation expense and general corporate overhead, partially offset by an increase in professional services expense. R&D expenses were $1.4 million, a 71% decrease versus Q2 2024, primarily due to an increase in contra R&D expenses or reductions to R&D expenses that we recognized due to nondilutive funding awards as well as decreases in manufacturing costs related to Ovaprene and development costs related to Sildenafil cream, partially offset by increases in costs related to development activities for other clinical and preclinical R&D programs, including DARE-HPV and DARE-LARC1.

We encourage investors to review the more detailed discussion of our financial statements, our financial condition, liquidity, capital resources and risk factors in our Form 10-Q for the quarter ended June 30, 2025, filed today. Due to technical difficulties, we will not be able to hold the Q&A session today. So I will turn it back over to the operator.

Operator: Thank you. And since there’s no Q&A and that concludes our event, conference call for today. Thank you so much for joining, and you may now disconnect.