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Aspira Women's Health Reports Full-Year 2023 Results

AWH reported full-year 2023 results, mostly in line with our estimates. Full-year 2023 revenue was $9.2 million, a 15% increase from 2022, and slightly below our $9.6 million estimate. Good expense control continued throughout the year, resulting in better-than-expected EPS of ($1.81), compared with our ($1.94) estimate. Our 2024 revenue estimate reflects annual growth of 20% to $11 million, slightly below our prior estimate, while our 2024 EPS estimate is ($1.55), as good cost control continues. We expect revenue growth of 45% and 55% in 2025 and 2026, respectively, as the EndoCheck launch hits its stride. Our EPS estimates for 2025 and 2026 are ($1.40) and ($1.02), respectively. The number of OvaSuite tests performed in 2023 was ~23,990, a 12% increase from 2022. In 4Q23, the average unit price (AUP) of OvaSuite increased slightly from 2022. During the summer of 2023, AWH conducted a commercial refresh with an overhaul of its sales and marketing function, which involved cutting unprofitable sales territories. This resulted in a 50% decrease from 2022 in sales and marketing expenses for the year. The resized sales territories resulted in 17 salespeople at the end of 2023. The company is looking to add three more positions this year. During the year, AWH received final crosswalk pricing determination from the Centers for Medicare and Medicaid Services (CMS) and will be reimbursed at a rate of $897 for all OvaWatch and Ova1 tests processed for Medicare patients. The company secured reimbursement for Ova1Plus tests from the California Department of Health Care Services at a rate of $897 for Medi-Cal patients. Near-term pipeline product EndoCheck showed the ability to successfully detect endometrioma in December 2023. AWH is currently evaluating the best commercial strategy and market launch program for the test. There is strong interest in EndoCheck from the National Institute of Health (NIH) and many others as this is the first ever non-invasive test for any form of endometriosis. The company is hoping to get a grant from the NIH to help get the test on the market. In 4Q23, AWH presented a late-breaking poster titled, “A Protein Biomarker Test and Artificial Intelligence-Based Algorithm for Ovarian Endometriosis” at the 71st Annual Scientific Meeting for the Society for Reproductive Investigation that highlighted data from EndoCheck. The company noted that among its current physician customer base, it has seen a lot of interest in getting access to this test, as it will be the first non-invasive way to detect endometriosis. There are a few treatments for endometriosis available now, but it is expected that many more could be developed and on the market, with the launch of a valid, non-invasive diagnostic tool. Other pipeline products include OvaMDx in ovarian cancer, a risk assessment tool designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of AWH’s current tests. AWH also established a Clinical Advisory Board as an element of its overall mission to develop and distribute high-impact diagnostic tools for gynecologic disease. Each member of the board is a recognized thought leader with deep clinical experience in gynecologic health.