Product Revenue Increased 30% to $1.8 million; OVA1plus Volume Grew 28% to 4,819 Units
New Ordering Physicians in the First Quarter Grew 47% to 603 Year Over Year
Board and Leadership appointments announced
Conference Call and Webcast scheduled for today, May 11th at 8:30 a.m. ET
AUSTIN, Texas, May 11, 2022 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on gynecologic disease, today reported its financial results for the first quarter ended March 31, 2022.
“We are pleased to announce our first quarter 2022 results. Strong commercial performance – especially the trend in new ordering physicians - should set the stage for commercial success for the rest of the year,” said Nicole Sandford, Aspira’s President and Chief Executive Officer. “We are also pleased to announce the acceptance of our OVAWatch manuscript, an important milestone on the path to the expansion of our ovarian cancer product portfolio. We believe these developments – along with the addition of an outstanding Executive to our leadership team and the nomination of two highly qualified Board Members – are strong indicators of things to come.”
Recent Corporate Highlights
Highlights of First Quarter 2022 vs. First Quarter 2021:
Highlights of First Quarter 2022 vs. Fourth Quarter 2021:
Conference Call and Webcast Details
Aspira will host a call today at 8:30 a.m. Eastern Time to discuss results followed by a question-and-answer period.
Toll Free: | 1-844-826-3033 |
International: | 1-412-317-5185 |
Conference ID: | 10166732 |
Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1546648&tp_key=889c6ae07f |
About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is transforming women’s health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women. Aspira Women’s Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1plusTM combines our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. Aspira GenetiXTM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health is working to deliver a portfolio of pelvic mass products over a patient’s lifetime with our cutting-edge research. The next generation of products in development include OVAWatchTM and EndoCheckTM. To improve patient accessibility, Aspira Women’s Health has recently launched our Aspira SynergyTM technology transfer platform to empower health systems, academics, regional labs, and physician group labs to conduct genetic and specialty tests in-house. 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 expected future effects of our commercial performance and the pending publication of our OVAWatch manuscript and our plans to launch OVAWatch. 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, 2021. These risk include, but are not limited to: 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; 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 environmental laws; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS, Inc.; 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:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel: 617-430-7577
[email protected]
Aspira Women’s Health Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(Amounts in Thousands, Except Share and Par Value Amounts) | ||||||||
(Unaudited) | ||||||||
March 31, | December 31, | |||||||
2022 | 2021 | |||||||
Assets | (Unaudited) | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 26,855 | $ | 37,180 | ||||
Accounts receivable | 1,136 | 1,027 | ||||||
Prepaid expenses and other current assets | 1,620 | 1,624 | ||||||
Inventories | 189 | 174 | ||||||
Total current assets | 29,800 | 40,005 | ||||||
Property and equipment, net | 480 | 464 | ||||||
Right-of-use assets | 331 | 346 | ||||||
Restricted cash | 250 | 250 | ||||||
Other assets | - | 14 | ||||||
Total assets | $ | 30,861 | $ | 41,079 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,298 | $ | 1,501 | ||||
Accrued liabilities | 4,035 | 5,299 | ||||||
Current portion of long-term debt | 223 | 201 | ||||||
Short-term debt | 519 | 779 | ||||||
Lease liability | 64 | 60 | ||||||
Total current liabilities | 6,139 | 7,840 | ||||||
Non-current liabilities: | ||||||||
Long-term debt | 2,646 | 2,718 | ||||||
Lease liability | 332 | 349 | ||||||
Total liabilities | 9,117 | 10,907 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock, par value $0.001 per share, 150,000,000 shares authorized at March 31, 2022 and December 31, 2021; 112,141,741 and 112,138,741 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 112 | 112 | ||||||
Additional paid-in capital | 502,628 | 501,788 | ||||||
Accumulated deficit | (480,996 | ) | (471,728 | ) | ||||
Total stockholders’ equity | 21,744 | 30,172 | ||||||
Total liabilities and stockholders’ equity | $ | 30,861 | $ | 41,079 | ||||
Aspira Women’s Health Inc. | |||||||
Condensed Consolidated Statements of Operations | |||||||
(Amounts in Thousands, Except Share and Per Share Amounts) | |||||||
(Unaudited) | |||||||
Three Months Ended | |||||||
March 31, | |||||||
2022 | 2021 | ||||||
Revenue: | |||||||
Product | $ | 1,835 | $ | 1,416 | |||
Genetics | 58 | 80 | |||||
Total revenue | 1,893 | 1,496 | |||||
Cost of revenue(1): | |||||||
Product | 857 | 655 | |||||
Genetics | 75 | 238 | |||||
Total cost of revenue | 932 | 893 | |||||
Gross profit | 961 | 603 | |||||
Operating expenses: | |||||||
Research and development(2) | 1,348 | 872 | |||||
Sales and marketing(3) | 4,497 | 3,108 | |||||
General and administrative(4) | 4,363 | 2,509 | |||||
Total operating expenses | 10,208 | 6,489 | |||||
Loss from operations | (9,247 | ) | (5,886 | ) | |||
Interest income (expense), net | (18 | ) | (24 | ) | |||
Other income (expense), net | (3 | ) | (10 | ) | |||
Net loss | $ | (9,268 | ) | $ | (5,920 | ) | |
Net loss per share - basic and diluted | $ | (0.08 | ) | $ | (0.05 | ) | |
Weighted average common shares used to compute basic and diluted net loss per common share | 112,139,038 | 108,661,712 | |||||
Non-cash stock-based compensation expense included in cost of revenue and operating expenses: | |||||||
(1) Cost of revenue | $ | 52 | $ | 34 | |||
(2) Research and development | (4 | ) | 26 | ||||
(3) Sales and marketing | 147 | 139 | |||||
(4) General and administrative | 643 | 290 |