Financial Performance - The company has an accumulated deficit of approximately $498.9 million as of December 31, 2022, and expects to incur a net loss and negative cash flows from operations for 2023[168][181]. - Total revenue for the year ended December 31, 2022, was $8,184,000, a 20% increase from $6,812,000 in 2021[1]. - Product revenue increased by 21% to $7,970,000, driven by a 23% increase in OvaSuite test volume to approximately 21,423 tests[2][3]. - Genetics revenue decreased by 12% to $214,000, with a 32% drop in the number of tests performed due to the discontinuation of the genetics testing line[4][5]. - Total cost of revenue was $3,865,000, a slight increase of 3% from $3,750,000 in 2021, with product costs rising by 23%[6]. - Research and development expenses rose by 12% to $5,953,000, primarily due to costs related to sponsored research collaborations[7]. - Sales and marketing expenses decreased by 13% to $14,948,000, attributed to reduced employment and consulting costs[8]. - General and administrative expenses increased by 22% to $16,183,000, mainly due to insourcing corporate functions and increased personnel costs[9]. - Net loss for the year was $27,170,000, an improvement of 14% from a net loss of $31,662,000 in 2021[10]. - Cash used in operating activities was $32,185,000, primarily due to the net loss and changes in fair value of warrant liabilities[11]. - Net cash provided by financing activities was $8,544,000, resulting from the 2022 Offering, with net proceeds of approximately $7,675,000[12]. - The company has incurred significant net losses and negative cash flows from operations since inception, raising substantial doubt about its ability to continue as a going concern[209]. Strategic Initiatives - The company plans to launch its second diagnostic algorithm, EndoCheck, for endometriosis diagnosis in the second half of 2023[166]. - The company aims to expand access to its tests among Medicaid patients and raise public awareness regarding the diagnostic superiority of Ova1Plus compared to CA-125[163]. - The company plans to continue commercializing Ova1Plus and expand managed care coverage in select markets in 2023[164]. - The company has established a Key Opinion Leader Network and added to its direct salesforce to support its commercialization efforts[164]. - The company is now credentialed to provide services to a total of 64 million Medicaid lives, representing 80% of the Medicaid population[213]. - A major global commercial payer agreed to cover OvaWatch effective April 1, 2023[213]. - The company plans to continue the development of a novel combined assay utilizing a new platform with collaborators, with Phase II collaboration beginning in 2023[215]. - The company added Medicaid coverage for multiple states, including Virginia and Pennsylvania, enhancing its market reach[212]. - The company has made significant advancements in its government strategy, including a requirement for CMS to develop a National Coverage Determination for multi-marker testing for ovarian cancer[212]. Financial Transactions - The company completed a public offering in 2021 resulting in net proceeds of approximately $47.86 million and another offering in 2022 with net proceeds of about $7.68 million[174][176]. - The company has entered into agreements to raise up to $22.5 million through equity offerings with Cantor Fitzgerald and Lincoln Park Capital[178]. - Payments of approximately $1.25 million are due for a sponsored research agreement with Harvard's Dana-Farber Cancer Institute, with 68% already paid[218]. Operational Challenges - The company has experienced labor shortages and may face future shortages of qualified employees, impacting its commercialization objectives[166]. - The company is engaged in two lease agreements, with one expiring on January 31, 2024, and the other on June 30, 2026[172]. Leadership Changes - Leadership updates include the appointment of a new Chief Financial Officer effective December 1, 2022[211]. Research and Development - The company published a paper validating the OvaWatch algorithm for ovarian cancer detection, highlighting its potential for early diagnosis[214].
Aspira Women’s Health (AWH) - 2022 Q4 - Annual Report