Release Date: August 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Dare Bioscience Inc (DARE, Financial) reported a comprehensive income of approximately $12.9 million for the second quarter, driven by proceeds from a royalty monetization transaction.
- The company ended the second quarter with approximately $16.4 million in cash and cash equivalents.
- Dare Bioscience Inc (DARE) has a robust pipeline with potential first-in-category product candidates, including Sildenafil Cream and Ovaprene.
- The commercialization of XACIATO, the first FDA-approved product from their portfolio, is progressing well with steady month-over-month increases in prescriptions.
- The company received $1 million as the latest installment under a grant agreement to support the development of DARE-LARC1, with potential total funding of up to $49 million.
Negative Points
- General and administrative expenses were approximately $2.4 million, a 16% decrease compared to Q2 2023, indicating cost-cutting measures such as reduced headcount.
- Research and development expenses were approximately $4.9 million, a 19% decrease compared to Q2 2023, which may impact the pace of product development.
- The FDA's review of the Phase 3 design for Sildenafil Cream is ongoing, causing delays in the initiation of the Phase 3 trial.
- Enrollment rates for the Phase 3 study of Ovaprene vary considerably across different sites, potentially delaying the study's completion.
- The company implemented a reverse stock split on July 1, 2024, which may indicate efforts to maintain compliance with stock exchange listing requirements.
Q & A Highlights
Q: With the timing updates for Ovaprene, can you give us a sense of what implications this has for top-line readout? And do you have any plans for an interim look?
A: We don't have a specific timing for the top-line readout yet. There's a difference in enrollment rates between some sites, but the central advertising campaign has generated significant patient interest. We anticipate having half of the subjects complete six months of assessment by the end of Q2 2025. We are considering an interim analysis at that point but need further enrollment to provide exact timing for the final top-line readout.
Q: Can you remind us of the typical use Pearl Index that would make Ovaprene a commercially compelling asset?
A: The Pearl Index for contraceptive methods varies widely. Non-hormonal methods like spermicides have a Pearl Index in the 27-28 range, while hormonal methods are more effective. Ovaprene's pre-pivotal data suggests it could be as effective as short-acting hormonal methods. Given its unique once-a-month, non-hormonal nature, it has a broad range of acceptability and commercial viability.
Q: Are you anticipating another meeting with the FDA for the Sildenafil Cream program to get final alignment?
A: It's not clear if another meeting will be needed. The FDA is reviewing a lot of data, and we've provided extensive information on outcome measures and clinically meaningful improvements. We are open to another meeting if necessary, but nothing definitive has been planned yet.
Q: How are you prioritizing your pipeline opportunities in the context of your current balance sheet?
A: Our priorities are Ovaprene and Sildenafil, given their advanced stages and significant market opportunities. We are focusing our operational and financial resources on these programs while also advancing other pipeline projects responsibly.
Q: Can you provide an update on the progress and market potential of XACIATO?
A: XACIATO, a treatment for bacterial vaginosis, became available nationwide in Q1 2024. The Organon sales team reports steady increases in prescriptions and positive clinical acceptance. We are unlocking access channels to ensure a smooth fulfillment experience for patients and providers.
Q: What are the next steps for DARE-HRT1 and DARE-VVA1 in the menopause space?
A: DARE-HRT1 is being prepared for a single Phase 3 clinical study for vasomotor symptoms of menopause. DARE-VVA1, a hormone-free vaginal candidate for sexual pain due to VVA, is Phase 2 ready. We are exploring opportunities to advance these programs and will provide updates as available.
Q: Can you elaborate on the financial impact of the royalty monetization transaction with XOMA?
A: The transaction provided $22 million in gross proceeds and ensures significant capital to advance our late-stage products. It allows us to focus on Ovaprene and Sildenafil Cream while retaining a significant majority of future economics and achieving attractive margins through retained net sales and commercial milestones.
Q: What are the anticipated milestones for Ovaprene and Sildenafil Cream in the coming quarters?
A: For Ovaprene, we aim to have half of the study participants complete six months of product use by the end of Q2 2025. For Sildenafil Cream, we are awaiting FDA feedback on the Phase 3 study design and plan to initiate Phase 3 preparations. We will provide updates on these milestones as they become available.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
