Full Press Release Details
Aspira Women's Health Reports Second Quarter 2023 Financial Results
Continued growth trend with second quarter revenue of $2.5 million, an increase of 23% over the second quarter of 2022.
OvaSuite volume of 6,289 units, an increase of 16% year-over-year
Achieved cash used in operations of $3.4 million, a decrease of 46% compared to the second quarter of 2022
Conference Call and Webcast scheduled for today 4:30 pm Eastern Time
AUSTIN, Texas August 14, 2023 Aspira Women's Health Inc. ( Aspira ) (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 second quarter ended June 30, 2023.
Our optimism continues to grow as we achieved sustained improvement across the company this quarter. OvaWatch test volume grew 80% in its second full quarter, contributing 14% of the total 6,289 OvaSuite tests performed. Test volume per field representative continues to improve, growing more than 69% to 598 for the six months ended June 30, 2023, as a result of the ongoing strategic refresh of our commercial programs, said Nicole Sandford, Aspira's President and Chief Executive Officer. As we look to the second half of the year, our focus is on the successful expansion of OvaWatch as a longitudinal monitoring test, and the launch of our EndoCheck blood test. Both efforts are progressing as planned.
Cash used in operations was $3.4 million, a decrease of nearly 46% compared to the second quarter of last year. Fiscal discipline, combined with the forgiveness of $1 million of debt, and an equity raise in July that brought net proceeds of $4.3 million, has strengthened our balance sheet and sets us up for a successful second half, Sandford continued.
The company lowered its operating cash utilization guidance for the second half of the year to between $6 and $8 million.
Second Quarter and Recent Corporate Highlights
Second Quarter 2023 Financial Highlights
First Half 2023 Financial Highlights
Conference Call and Webcast Details
Aspira will host a conference call today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:
Time:4:30 pm Eastern Time
Toll Free:(877) 407-4018
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 transforming women's gynecological health with the discovery, development, and commercialization of innovative testing options for women of all races and ethnicities, starting with ovarian cancer.
Our ovarian cancer risk assessment portfolio is marketed to healthcare providers as OvaSuiteSM. OvaWatchSM is a non-invasive, blood-based test intended for use in the initial clinical assessment of ovarian cancer risk in women with benign or indeterminate adnexal masses for which surgical intervention may be either premature or unnecessary. With a negative predictive value (NPV) of 99%, OvaWatch allows physicians to confidently rule out ovarian cancer malignancy and choose the appropriate clinical management for the right patient at the right time. Ova1Plus combines our FDA-cleared products, Ova1 and Overa , to detect risk of ovarian malignancy in women with adnexal masses planned for surgery.
EndoCheck , the first-of-its-kind non-invasive diagnostic test for endometriosis, is currently in development. Visit our website for more information at www.aspirawh.com.
Forward-Looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the potential effects of widespread use of OvaWatch and the availability of OvaWatch in New York. Forward-looking statements involve a number of risks and uncertainties. Words such as may, expects, intends, anticipates, believes, estimates, plans, seeks, could, should, continue, will, potential, projects and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties, and assumptions, including those described in the section entitled Risk Factors in Aspira's Annual Report on Form 10-K for the year ended December 31, 2022, and as supplemented in Aspira's 10-Q filing for the quarter ended March 31, 2023. These risks include, but are not limited to: our ability to continue as a going concern; our ability to comply with Nasdaq's continued listing requirements; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates, including our ability to continue secure reimbursement for our products; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform laboratory developed tests; our ability to comply with Food and Drug Administration ( FDA ) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers' ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations. The events and circumstances reflected in Aspira's forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Relations Contact:
LifeSci Advisors, LLC
Aspira Women's Health Inc.
Condensed Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
| June 30, | December 31, | ||||
| 2023 | 2022 | ||||
| Assets | (Unaudited) | ||||
| Current assets: | |||||
| Cash and cash equivalents | $ | 4,246 | $ | 13,306 | |
| Accounts receivable, net of reserves of $57 and $9, at June 30, 2023 and December 31, 2022, respectively | 1,638 | 1,245 | |||
| Prepaid expenses and other current assets | 706 | 1,442 | |||
| Inventories | 272 | 316 | |||
| Total current assets | 6,862 | 16,309 | |||
| Property and equipment, net | 261 | 368 | |||
| Right-of-use assets | 342 | 282 | |||
| Restricted cash | 255 | 251 | |||
| Other assets | - | 163 | |||
| Total assets | $ | 7,720 | $ | 17,373 | |
| Liabilities and Stockholders' Equity (Deficit) | |||||
| Current liabilities: | |||||
| Accounts payable | $ | 1,072 | $ | 881 | |
| Accrued liabilities | 3,549 | 3,650 | |||
| Current portion of long-term debt | 259 | 403 | |||
| Short-term debt | 306 | 764 | |||
| Lease liability | 188 | 77 | |||
| Total current liabilities | 5,374 | 5,775 | |||
| Non-current liabilities: | |||||
| Long-term debt | 1,334 | 2,315 | |||
| Lease liability | 228 | 272 | |||
| Warrant liabilities | 1,312 | 2,280 | |||
| Total liabilities | 8,248 | 10,642 | |||
| Commitments and contingencies | |||||
| Stockholders' equity (deficit): | |||||
| Common stock, par value $0.001 per share, 200,000,000 and 150,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 8,473,363 and 8,306,326 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 9 | 8 | |||
| Additional paid-in capital | 506,745 | 505,621 | |||
| Accumulated deficit | (507,282) | (498,898) | |||
| Total stockholders' equity (deficit) | (528) | 6,731 | |||
| Total liabilities and stockholders' equity (deficit) | $ | 7,720 | $ | 17,373 |
Aspira Women's Health Inc.
Condensed Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Par Value Amounts)
| Three Months Ended | Six Months Ended | ||||||||||
| June 30, | June 30, | ||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||
| Revenue: | |||||||||||
| Product | $ | 2,491 | $ | 2,018 | $ | 4,806 | $ | 3,853 | |||
| Genetics | - | 48 | 1 | 106 | |||||||
| Total revenue | 2,491 | 2,066 | 4,807 | 3,959 | |||||||
| Cost of revenue (1) : | |||||||||||
| Product | 941 | 1,036 | 2,066 | 1,893 | |||||||
| Genetics | - | 64 | - | 139 | |||||||
| Total cost of revenue | 941 | 1,100 | 2,066 | 2,032 | |||||||
| Gross profit | 1,550 | 966 | 2,741 | 1,927 | |||||||
| Operating expenses: | |||||||||||
| Research and development (2) | 693 | 1,410 | 1,924 | 2,758 | |||||||
| Sales and marketing (3) | 1,772 | 3,580 | 4,334 | 8,077 | |||||||
| General and administrative (4) | 3,406 | 4,196 | 6,573 | 8,559 | |||||||
| Total operating expenses | 5,871 | 9,186 | 12,831 | 19,394 | |||||||
| Loss from operations | (4,321) | (8,220) | (10,090) | (17,467) | |||||||
| Change in fair value of warrant liabilities | 992 | - | 968 | - | |||||||
| Interest income (expense), net | 8 | (10) | 34 | (28) | |||||||
| Other income (expense), net | 1,004 | (13) | 704 | (16) | |||||||
| Net loss | $ | (2,317) | $ | (8,243) | $ | (8,384) | $ | (17,511) | |||
| Net loss per share - basic and diluted | $ | (0.28) | $ | (1.10) | $ | (1.00) | $ | (2.34) | |||
| Weighted average common shares used to compute basic and diluted net loss per common share | 8,400,157 | 7,482,860 | 8,357,013 | 7,479,435 | |||||||
| Non-cash stock-based compensation expense included in cost of revenue and operating expenses: | |||||||||||
| (1) Cost of revenue | $ | 2 | $ | 35 | $ | 15 | $ | 87 | |||
| (2) Research and development | 56 | 53 | 133 | 49 | |||||||
| (3) Sales and marketing | 139 | 58 | 122 | 205 | |||||||
| (4) General and administrative | 291 | 464 | 351 | 1,107 |