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Daré Bioscience(DARE) - 2023 Q4 - Annual Results
DAREDaré Bioscience(DARE)2024-03-28 12:05

Financial Performance - Daré Bioscience reported total revenue of approximately 2.8millionfortheyearendedDecember31,2023,includinga2.8 million for the year ended December 31, 2023, including a 1.0 million payment in July and a 1.8millionmilestonepaymentinOctoberfromcollaboratorOrganonrelatedtoXACIATO[21]−Totalrevenuefor2023was1.8 million milestone payment in October from collaborator Organon related to XACIATO[21] - Total revenue for 2023 was 2,807,885, a decrease of 72.1% compared to 10,000,000in2022[38]−Thecompanyrecognizedanetlossofapproximately10,000,000 in 2022[38] - The company recognized a net loss of approximately 30.1 million for 2023, with general and administrative expenses of approximately 12.1million,upabout812.1 million, up about 8% compared to the prior year[21] - Net loss for 2023 was 30,161,391, compared to a net loss of 30,947,738in2022,representinga2.530,947,738 in 2022, representing a 2.5% improvement[38] - Comprehensive loss for 2023 was 30,170,976, compared to 31,144,076in2022,showinga3.131,144,076 in 2022, showing a 3.1% improvement[38] - Loss per common share for 2023 was 0.35, slightly improved from 0.37in2022[38]−Cashandcashequivalentsdecreasedto0.37 in 2022[38] - Cash and cash equivalents decreased to 10,476,056 in 2023 from 34,669,605in2022,adeclineof69.734,669,605 in 2022, a decline of 69.7%[38] - Total assets decreased to 21,282,215 in 2023 from 43,826,383in2022,areductionof51.443,826,383 in 2022, a reduction of 51.4%[38] - Total liabilities decreased to 26,329,855 in 2023 from 32,714,273in2022,adecreaseof19.532,714,273 in 2022, a decrease of 19.5%[38] - Operating expenses for 2023 were 33,747,765, down 18.5% from 41,385,488in2022[38]ResearchandDevelopment−Researchanddevelopmentexpenseswereapproximately41,385,488 in 2022[38] Research and Development - Research and development expenses were approximately 21.5 million in 2023, down from approximately 30.0millionintheprioryear,primarilyduetocostsassociatedwithclinicalstudies[21]−DareˊcommencedthePhase3clinicalstudyforitshormone−freemonthlyintravaginalcontraceptivecandidateOvapreneinDecember2023,withrecruitmentcurrentlyunderwayat17sitesacrosstheU.S.[10]−TheFDAhasclearedtheinvestigationalnewdrugapplicationforDARE−VVA1,anon−hormonaltreatmentforsexualpain,allowingDareˊtoplanforaPhase2clinicalstudy[18]−PositivetoplineresultswereannouncedforDARE−PDM1,aninvestigationalformulationofdiclofenacfortreatingmenstrualcrampingpain,followingaPhase1study[16]−DareˊanticipatesprovidingupdatesontheFDAfeedbackandPhase3studydesignforSildenafilCreamin2Q−2024[14]CollaborationsandMilestones−ThefirstshipmentofXACIATO™triggereda30.0 million in the prior year, primarily due to costs associated with clinical studies[21] - Daré commenced the Phase 3 clinical study for its hormone-free monthly intravaginal contraceptive candidate Ovaprene in December 2023, with recruitment currently underway at 17 sites across the U.S.[10] - The FDA has cleared the investigational new drug application for DARE-VVA1, a non-hormonal treatment for sexual pain, allowing Daré to plan for a Phase 2 clinical study[18] - Positive topline results were announced for DARE-PDM1, an investigational formulation of diclofenac for treating menstrual cramping pain, following a Phase 1 study[16] - Daré anticipates providing updates on the FDA feedback and Phase 3 study design for Sildenafil Cream in 2Q-2024[14] Collaborations and Milestones - The first shipment of XACIATO™ triggered a 1.8 million milestone payment from Organon, and the product is now available nationwide by prescription[7] - Daré is eligible to receive double-digit royalties based on net sales of XACIATO and up to 180millioninpotentialmilestonepaymentsfromOrganon[8]FutureOutlook−Thecompanyexpectsareductionin2024generalandadministrativeexpensestoapproximately180 million in potential milestone payments from Organon[8] Future Outlook - The company expects a reduction in 2024 general and administrative expenses to approximately 10.0 million, despite projected accrual-based non-cash expenses[21] - The weighted average number of common shares outstanding increased to 87,303,701 in 2023 from 84,571,805 in 2022[38] Recognition - The company has been recognized for its contributions to women's health and innovation, with leadership accolades in 2022 and 2023[33]