| Segment Information |
SEGMENT INFORMATION Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker (“CODM”), in deciding how to allocate resources and in assessing performance. The Company and the Company’s chief operating decision maker view the Company’s operations and manage its business in one operating segment, which is the business of identifying, developing and commercializing pharmaceutical products that target unmet needs in women's health. The CODM, who is the chief executive officer (“CEO”), manages and allocates resources to the operations of the Company on a consolidated basis. The Company’s measure of segment profit or loss is net loss. Managing and allocating resources on a consolidated basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions and research and development projects that are in line with the Company’s long-term company-wide strategic goals. Consistent with this decision-making process, the CEO uses consolidated financial information for purposes of evaluating performance, forecasting future period financial results, allocating resources and setting incentive targets. Operating expenses are used to monitor budget versus actual results. The CODM does not review assets in evaluating the results of the Company, and therefore, such information is not presented. In addition, substantially all of the Company's revenue was generated in the United States and substantially all of the Company's long-lived assets reside in the United States.
The following table summarizes the segment's financial information including the Company’s significant segment expenses: | | | | | | | | | | | | | | | | | | | | | | | | | Three Months Ended June 30, | | Six Months Ended June 30, | | 2026 | | 2025 | | 2026 | | 2025 | | Revenue: | | | | | | | | | | | | | | | | | | | | | | | | Research and development services and royalty revenue | $ | 187,546 | | | $ | (21,172) | | | $ | 340,001 | | | $ | 4,255 | | | Total revenue | 187,546 | | | (21,172) | | | 340,001 | | | 4,255 | | | Cost of revenues | 319,889 | | | — | | | 562,214 | | | — | | | Segment operating expenses: | | | | | | | | | Research and development: | | | | | | | | | Direct program costs: | | | | | | | | Ovaprene (1) | 843,503 | | | 1,316,372 | | | 2,075,263 | | | 2,812,101 | | Sildenafil Cream (2) | 134,769 | | | 49,881 | | | 202,560 | | | 261,270 | | | Other advanced clinical stage programs | 1,244,028 | | | 975,489 | | | 1,619,791 | | | 1,466,051 | | Phase 1 and Phase 1-ready clinical stage programs (1) | 164,068 | | | 628,595 | | | 260,123 | | | 1,125,342 | | | Preclinical stage programs | 1,457,723 | | | 1,718,320 | | | 2,626,102 | | | 2,767,058 | | | | | | | | | | | Personnel-related (including stock-based compensation) | 1,084,019 | | | 1,209,437 | | | 2,276,881 | | | 2,701,684 | | Contra-R&D expenses (3) | (4,017,949) | | | (3,780,794) | | | (7,087,095) | | | (6,399,167) | | | Total research and development direct program costs | 910,161 | | | 2,117,300 | | | 1,973,625 | | | 4,734,339 | | | Indirect costs: | | | | | | | | | Other indirect costs | 30,654 | | | 70,462 | | | 59,500 | | | 199,196 | | | Contra R&D expenses | (698,849) | | | (759,000) | | | (1,130,697) | | | (1,207,392) | | | Total research and development indirect costs | (668,195) | | | (688,538) | | | (1,071,197) | | | (1,008,196) | | | Total research and development | 241,966 | | | 1,428,762 | | | 902,428 | | | 3,726,143 | | | Selling, general and administrative | 2,593,671 | | | 2,377,866 | | | 4,842,237 | | | 4,687,030 | | | | | | | | | | | Total segment operating expenses | 2,835,637 | | | 3,806,628 | | | 5,744,665 | | | 8,413,173 | | | Loss from operations | (2,967,980) | | | (3,827,800) | | | (5,966,878) | | | (8,408,918) | | | | | | | | | | | Interest expense | 190,965 | | | 268,532 | | | 390,359 | | | 402,583 | | | Interest income | (176,145) | | | (69,847) | | | (367,833) | | | (226,469) | | Other income, net | 27 | | | 10,002 | | | 6,742 | | | 190,242 | | | Net loss | $ | (2,982,773) | | | $ | (4,016,483) | | | $ | (5,982,662) | | | $ | (8,394,790) | | (1)The applicable program(s) receive grant funding and/or the Tax Incentive. The amount of R&D expense for the period indicated is shown on a gross basis (i.e., without deducting the amount of contra R&D expense for the applicable program(s). See footnote (3) below. (2)The amount of expenses includes expenses for Sildenafil Cream, 3.6% and DARE to PLAY Sildenafil Cream. (3)These contra R&D expenses were recognized as follows for the three months ended June 30, 2026 and 2025: (a) Ovaprene, $0.8 million and $0.4 million, respectively; (b) other advanced clinical stage programs, $1.3 million and $1.0 million, respectively, (c) Phase 1 and Phase 1-ready clinical stage programs, $0 and $0.1 million, respectively; and (d) preclinical stage programs, $1.9 million and $2.2 million, respectively. These contra R&D expenses were recognized as follows for the six months ended June 30, 2026 and 2025: (a) Ovaprene, $1.7 million and $0.9 million, respectively; (b) other advanced clinical stage programs, $1.8 million and $1.5 million, respectively, (c) Phase 1 and Phase 1-ready clinical stage programs, $0 million and $0.2 million, respectively; and (d) preclinical stage programs, $3.6 million and $3.8 million, respectively. |
|