Daré Bioscience (DARE) Q2 2024 earnings summary

Executive summary

• Achieved Q2 2024 net income of $12.9M, reversing prior losses, mainly from a $20.4M gain on the sale of royalty and milestone rights to XOMA.

• Focused on advancing a broad portfolio of first-in-category women's health products, with late-stage assets including Ovaprene and Sildenafil Cream.

• XACIATO, the first FDA-approved product, is available nationwide and continues U.S. commercialization via Organon, with growing prescriptions.

• Pipeline includes menopause-related candidates DARE-HRT1 and DARE-VVA1, and robust clinical development for Ovaprene and Sildenafil Cream.

• Operates as a single business segment focused on women's health, spanning contraception, vaginal health, menopause, sexual health, and fertility.

Financial highlights

• Q2 2024 net income: $12.9M, compared to a net loss of $8.8M in Q2 2023, driven by a $20.4M royalty sale.

• Q2 2024 revenue: $22K, all from XACIATO royalties; operating expenses were $7.4M, down 18% year-over-year.

• R&D expenses were $4.9M in Q2 2024, a 19% decrease from Q2 2023; G&A expenses were $2.4M, down 16% year-over-year.

• Cash and cash equivalents at June 30, 2024, totaled $16.4M, with working capital of $6.2M.

• Cash provided by operations in H1 2024 was $6.1M, compared to $22.7M used in H1 2023.

Outlook and guidance

• Full-year 2024 R&D expenses anticipated to be lower than 2023, with focus on Ovaprene and Sildenafil Cream.

• Significant losses and negative cash flows are expected for at least the next several years; current cash is insufficient for the next 12 months.

• Initiation of Sildenafil Cream Phase 3 study contingent on FDA alignment and capital resources; each Phase 3 study estimated at $15M.

• Interim analysis for Ovaprene Phase 3 possible once half of target participants complete six months of use, with further timing updates as enrollment progresses.

• Advancement of other programs, including DARE-LARC1, depends on securing additional funding.