Aspira Women’s Health Reports Fourth Quarter and Full Year 2023 Financial Results
- 15% increase in 2023 OvaSuite revenue to $9.2 million
- 12% rise in OvaSuite volume to 23,990 units
- Lowered cash utilization in Q4 and full-year 2023
- Successful conference call and webcast held
- Raised $5.5 million in a direct offering
- Secured reimbursement agreements for Ova1 and Ova1Plus tests
- Improved gross profit margin to 57.5% in 2023
- Decreased operating cash usage by 49% in 2023
- None.
Insights
The reported increase in OvaSuite revenue and unit sales for Aspira Women's Health Inc. indicates a positive growth trajectory for the company. A 15% year-over-year rise in revenue, along with a 12% increase in unit sales, suggests that the company's market penetration and sales strategies are effective. The decline in cash utilization for both the fourth quarter and the full year highlights improved operational efficiency and could signal a strengthening financial position. The gross proceeds of $5.5 million from a registered direct offering demonstrate the company's ability to attract investment, which is essential for sustaining research and development as well as commercial expansion efforts.
From an investor's perspective, the final crosswalk pricing determination from CMS and the approval for reimbursement rates are critical developments. These determinations often serve as a benchmark for the market's valuation of diagnostic tests and can significantly influence revenue projections. The exclusive distribution agreement with Hi-Precision Laboratories expands Aspira's international reach, potentially opening up new revenue streams and diversifying market risk. However, investors should monitor the company's ability to maintain and grow its gross profit margin, which has seen a slight decrease from the previous year.
Aspira's focus on women's health diagnostics, particularly in the domain of gynecologic diseases, positions the company within a specialized and growing sector of the healthcare market. The innovation in proteomic blood tests and AI-enabled diagnostics for ovarian cancer and endometriosis represents a competitive edge in an industry where early and accurate detection can significantly impact patient outcomes. The company's ability to innovate and secure intellectual property around these advancements could drive long-term growth.
The strategic decision to reduce sales and marketing expenses by 40% while maintaining revenue growth suggests a shift towards more efficient marketing channels or a stronger reliance on partnerships and collaborations. The formation of a Clinical Advisory Board and the appointment of Dr. Sandra Milligan as President indicate an investment in leadership and expertise, which could enhance the company's research and development capabilities. These moves are likely to be well-received by stakeholders looking for signs of sustainable growth and innovation leadership.
The advancements in Aspira's diagnostic tools, particularly the non-invasive tests for ovarian endometriosis and the use of miRNA-protein models for ovarian cancer triage, are significant. These developments could lead to improved patient outcomes through better diagnostic accuracy, which in turn, can enhance the company's reputation and credibility in the medical community. The adoption of such tests by healthcare providers hinges on clinical efficacy, cost-effectiveness and reimbursement coverage, which appears to be aligning favorably for Aspira with the recent CMS reimbursement rate determinations.
The data presented at scientific meetings serves as a form of peer validation, potentially accelerating the adoption of Aspira's tests in clinical practice. However, it is important to consider the long-term research and development costs and the need for continuous innovation to stay ahead in a competitive market. The decrease in research and development expenses, if not due to achieved efficiencies, could be a concern if it reflects a reduction in investment in future product pipelines.
2023 OvaSuite revenue of
2023 OvaSuite volume of 23,990 units, an increase of
Cash utilization declined in both the fourth quarter and full-year 2023 to
Conference Call and Webcast scheduled for today at 8:30 am ET
AUSTIN, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or the “Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today reported its financial results for the fourth quarter and year ended December 31, 2023.
“We made a great deal of progress in 2023. Not only were we able to cut our cash used in operations in half by aligning spending to business needs, but we simultaneously increased revenues and test volume, implemented enhancements to our commercial organization and achieved important market access milestones,” said Nicole Sandford, Chief Executive Officer of Aspira. “Progress in our innovation program continued to accelerate with the announcement in December of the first ever proteomic blood test to identify endometriomas and the achievement of major milestones in the development of our promising AI-enabled protein and miRNA diagnostic tests for ovarian cancer and endometriosis.”
Sandford continues, “Now, we turn towards 2024 with a strong, talented team and unprecedented momentum for women's health progress at both the Federal and state levels. The hard work of the past two years has positioned us to rise to these opportunities and reach our full potential.”
Fourth Quarter 2023 and Recent Corporate Highlights
- Raised
$5.5 million in gross proceeds through a registered direct offering with a single healthcare focused institutional investor alongside participation from Nicole Sandford, CEO of Aspira, as well as certain existing shareholders.
- Received final crosswalk pricing determination from the Centers for Medicare & Medicaid Services (CMS) and approval of the crosswalk of the fee to be paid to the company for OvaWatch to the fee paid historically for Ova1. Aspira will be reimbursed at a rate of
$897 for all OvaWatch and Ova1 tests processed for Medicare patients meeting applicable coverage requirements.
- Announced an exclusive 5-year distribution agreement with Hi-Precision Laboratories, one of the largest medical laboratories in the Philippines.
- Presented a poster, entitled: “Improving the diagnostic accuracy of an ovarian cancer triage test using a joint miRNA-protein model,” at the AACR Special Conference in Cancer Research. The poster highlighted data showing miRNA’s potential to improve the diagnostic accuracy of non-invasive diagnostic tests suggesting that using combined approaches could improve the triaging of patients with suspected ovarian cancers.
- Presented a late-breaking poster entitled “A Protein Biomarker Test and Artificial Intelligence-Based Algorithm for Ovarian Endometriosis,” at the 71st Annual Scientific Meeting for the Society for Reproductive Investigation. The poster highlighted data from the first non-invasive test for ovarian endometriosis.
- Secured reimbursement for Ova1Plus from the California Department of Health Care Services. Aspira will be reimbursed at a rate of
$897 for all Ova1Plus tests processed for Medi-Cal patients meeting applicable coverage requirements.
- Established a Clinical Advisory Board as an element of the company’s 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 expertise in gynecologic health.
- Named Dr. Sandra Milligan as President with direct responsibilities for Research and Development, Operations, Information Technology, and Human Resources.
Fourth Quarter 2023 Financial Highlights
- Product revenue was
$2.1 million for the three months ended December 31, 2023, compared to$2.1 million for the same period in 2022. The number of OvaSuite tests performed was approximately 5,659 during the three months ended December 31, 2023, flat when compared to the approximately 5,642 OvaSuite tests for the same period in 2022. The average unit price (AUP) increased to$376 for the three months ended December 31, 2023, compared to$369 for the same period in 2022.
- Gross profit margin was
57.2% for the three months ended December 31, 2023, compared to57.6% for the same period in 2022.
- Research and development expenses for the three months ended December 31, 2023, increased by
$0.1 million , or7% , compared to the same period in 2022.
- Sales and marketing expenses for the three months ended December 31, 2023, decreased by
$1.1 million , or40% , compared to the same period in 2022. This decrease was primarily due to decreased employment-related expenses and travel costs.
- General and administrative expenses for the three months ended December 31, 2023, increased by
$0.1 million , or4% , compared to the same period in 2022.
Full Year 2023 Highlights
- Product revenue was
$9.2 million for the year ended December 31, 2023, compared to$8.0 million for the same period in 2022. The15% product revenue increase was due to the addition of the Company’s OvaWatch product, and an increase in the average unit price (AUP) per test to$382 for the year ended December 31, 2023, compared to$372 for the same period in 2022.
- The number of OvaSuite tests performed increased
12% to approximately 23,990 tests during the year ended December 31, 2023, compared to approximately 21,423 tests for the same period in 2022.
- Gross profit margin was
57.5% for the year ended December 31, 2023, compared to52.8% for the year ended December 31, 2022. The change in gross margin was primarily due to a decrease in variable lab supply and shipping costs compared to the prior year.
- Research and development expenses for the year ended December 31, 2023, decreased by
$1.9 million , or32% , compared to the same period in 2022. The decrease was primarily due to a decrease in costs related to the Company’s sponsored research collaboration agreements, a decrease in consulting expenses and a decrease in costs due to the closure of a research and development lab in 2023.
- Sales and marketing expenses for the year ended December 31, 2023, decreased by
$7.1 million , or48% , compared to the same period in 2022. This decrease was primarily due to decreased employment-related expenses and travel costs.
- General and administrative expenses for the year ended December 31, 2023, decreased by
$2.4 million , or16% , compared to the same period in 2022. This decrease was primarily due to a decrease in employment-related expenses and a decrease in outside legal costs, offset by increased accounting costs.
Balance Sheet Highlights
As of December 31, 2023, Aspira had
Conference Call and Webcast Details
Aspira will host a conference call beginning at 8:30 am ET today, March 28, 2024. Conference call and webcast details are as follows:
| Time: Toll Free: International: Webcast: | 8:30 am ET 877-407-4018 201-689-8471 Click HERE |
The webcast will also be available on the Events & Presentations page of the Aspira Women’s Health Investor Relations website. An archive of the webcast replay will be available on the Company’s website for up to 90 days.
About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.
OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of
Our in-development test pipeline is designed to expand our ovarian cancer portfolio and addresses the tremendous need for noninvasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, our OvaMDxSM risk assessment is designed to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, EndoCheckSM is the first-ever noninvasive test designed to identify endometriomas, one of the most commonly occurring forms of endometriosis. The EndoMDxSM test is designed to combine microRNA and protein biomarkers with patient data to identify all endometriosis.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the pipeline development and other statements that are predictive in nature. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as “designed to,” “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this press release and other factors that may cause such differences include the satisfaction of customary closing conditions related to the offering and the expected timing of the closing of the offering. These and additional risks and uncertainties are described more fully in the company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 10-K, for the fiscal year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira’s expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company’s assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.
Investor Relations Contact:
Torsten Hombeck, Ph.D.
Chief Financial Officer
Aspira Women’s Health
Investors@aspirawh.com
| Aspira Women’s Health Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (Amounts in Thousands, Except Share and Par Value Amounts) | ||||||||
| (Unaudited) | ||||||||
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,597 | $ | 13,306 | ||||
| Accounts receivable, net of reserves of | 1,459 | 1,245 | ||||||
| Prepaid expenses and other current assets | 997 | 1,442 | ||||||
| Inventories | 227 | 316 | ||||||
| Total current assets | 5,280 | 16,309 | ||||||
| Property and equipment, net | 165 | 368 | ||||||
| Right-of-use assets | 528 | 282 | ||||||
| Restricted cash | 258 | 251 | ||||||
| Other assets | 31 | 163 | ||||||
| Total assets | $ | 6,262 | $ | 17,373 | ||||
| Liabilities and Stockholders’ (Deficit) Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,261 | $ | 881 | ||||
| Accrued liabilities | 2,863 | 3,402 | ||||||
| Current portion of long-term debt | 166 | 403 | ||||||
| Short-term debt | 670 | 764 | ||||||
| Lease liability | 159 | 77 | ||||||
| Total current liabilities | 5,119 | 5,527 | ||||||
| Non-current liabilities: | ||||||||
| Long-term debt | 1,430 | 2,315 | ||||||
| Lease liability | 427 | 272 | ||||||
| Warrant liabilities | 1,651 | 2,280 | ||||||
| Total liabilities | 8,627 | 10,394 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ (deficit) equity: | ||||||||
| Common stock, par value | 11 | 8 | ||||||
| Additional paid-in capital | 515,927 | 508,584 | ||||||
| Accumulated deficit | (518,303 | ) | (501,613 | ) | ||||
| Total stockholders’ (deficit) equity | (2,365 | ) | 6,979 | |||||
| Total liabilities and stockholders’ (deficit) equity | $ | 6,262 | $ | 17,373 | ||||
| Aspira Women’s Health Inc. | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (Amounts in Thousands, Except Share and Per Share Amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product | $ | 2,130 | $ | 2,080 | $ | 9,153 | $ | 7,970 | ||||||||
| Genetics | - | 73 | 1 | 214 | ||||||||||||
| Total revenue | 2,130 | 2,153 | 9,154 | 8,184 | ||||||||||||
| Cost of revenue: | ||||||||||||||||
| Product | 911 | 926 | 3,892 | 3,694 | ||||||||||||
| Genetics | - | (13 | ) | - | 167 | |||||||||||
| Total cost of revenue | 911 | 913 | 3,892 | 3,861 | ||||||||||||
| Gross profit | 1,219 | 1,240 | 5,262 | 4,323 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,077 | 1,002 | 4,035 | 5,917 | ||||||||||||
| Sales and marketing | 1,743 | 2,888 | 7,812 | 14,915 | ||||||||||||
| General and administrative | 2,534 | 2,441 | 12,267 | 14,629 | ||||||||||||
| Total operating expenses | 5,354 | 6,331 | 24,114 | 35,461 | ||||||||||||
| Loss from operations | (4,135 | ) | (5,091 | ) | (18,852 | ) | (31,138 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Change in fair value of warrant liabilities | 862 | 468 | 629 | 1,704 | ||||||||||||
| Interest income, net | 2 | 27 | 48 | 17 | ||||||||||||
| Forgiveness of DECD loan | - | - | 1,000 | - | ||||||||||||
| Other income (expense), net | 182 | 5 | 485 | (468 | ) | |||||||||||
| Total other income (expense), net | 1,046 | 500 | 2,162 | 1,253 | ||||||||||||
| Net loss | $ | (3,089 | ) | $ | (4,591 | ) | $ | (16,690 | ) | $ | (29,885 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.30 | ) | $ | (0.55 | ) | $ | (1.81 | ) | $ | (3.85 | ) | ||||
| Weighted average common shares used to compute basic and diluted net loss per common share | 10,408,132 | 8,299,729 | 9,233,306 | 7,769,109 | ||||||||||||
FAQ
What was the percentage increase in OvaSuite revenue for Aspira Women’s Health Inc. in 2023?
How much was the cash utilization decline in the fourth quarter of 2023 for Aspira Women’s Health Inc.?
What was the gross profit margin for Aspira Women’s Health Inc. in the year ended December 31, 2023?
How much did Aspira Women’s Health Inc. raise through a registered direct offering?
What was the change in operating cash usage for Aspira Women’s Health Inc. in 2023 compared to 2022?
