Company: DARE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001401914-25-000050
Chunk: 104

Company: Dare Bioscience, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 2
Chunk 104
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 recognized as non-cash royalty revenue. Generally, because the royalties are required to be paid more than 45 days after the end of each quarter other than with respect to the fourth quarter, we estimate the non-cash royalty revenue we will recognize for a particular quarter based on our analysis of historical experience and interim data provided by Organon including its publicly announced sales. Differences between actual and estimated royalty revenue will be adjusted for in the quarter in which the actual amount becomes known, which is generally expected to be the following quarter. For information regarding potential payments to upstream licensors, see Note 3 “Strategic Agreements” to the accompanying condensed consolidated financial statements. For information regarding our contractual obligations to XOMA and UiE, see Note 8 “Royalty Purchase Agreements” and Note 7 “Royalty Interest Financing,” respectively, to the accompanying condensed consolidated financial statements. 

Research and Development Expenses

Research and development, or R&D, represents a core operational focus. We are actively advancing multiple product candidates through preclinical and clinical development, supported in part by significant non-dilutive grant funding from governmental and non-governmental organizations. 

Although our R&D activities remain substantial, as explained in more detail below, grant funding and other financial awards offset a significant portion of our R&D expenses. As a result, our reported operating expenses may appear to be weighted more heavily toward general and administrative, or G&A, expenses. However, this reflects the reduction to R&D expenses (contra R&D expense) as a result of grant funding and other financial awards, rather than a reduction in our commitment to or investment in R&D activities.

 We expect our R&D expenses will continue to represent the majority of our operating expenses, on a pre-contra R&D expenses basis, for at least the next twelve months. R&D expenses consist primarily of:

•direct program costs, including:

◦expenses incurred under agreements with clinical research organizations (CROs), investigative sites and other third parties that assist in the conduct of our clinical trials and nonclinical studies and conduct other R&D and regulatory affairs activities on our behalf,

◦contract manufacturing expenses, primarily for the production of materials for use in our clinical trials and   nonclinical studies;

◦expenses related to production of select proprietary formulations by 503B-registered outsourcing facilities prior to commercial launch of the product via Section 503B compounding; 

◦transaction costs related to acquisitions of companies, technologies and related intellectual property, and other assets, and

◦milestone payments due