08/10/2022 | Press release | Distributed by Public on 08/10/2022 05:54
August 10, 2022 07:30 ET
Increased product revenue by 17% to $2.0 million; Grew OVA1plus volume by 19% to 5,411 units
Entered into a research agreement with Harvard's Dana Farber Cancer Institute, Brigham & Women's Hospital, and Medical University of Lodzfor development of a diagnostic test for endometriosis
Reduced cash utilization by $3.9 Million in the Second Quarter 2022
Conference Call and Webcast scheduled for today, August 10th at 8:30 a.m. ET
AUSTIN, Texas, Aug. 10, 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 second quarter ended June 30, 2022.
"We are pleased by our continued progress and execution during the second quarter, particularly on our three key strategic initiatives: Growth, Innovation, and Operational Excellence. Our commercial team achieved strong sequential and year-over-year growth that will be further fueled in the second half by our recently announced OVA1plus co-marketing agreement with BioReference," said Nicole Sandford, President and Chief Executive Office of Aspira.
Ms. Sandford continued, "On the innovation side, we reiterate our intention to launch OvaWatch - our next generation ovarian cancer laboratory developed test - by the end of the year. Today, we also announce an exciting expansion to our relationship with a consortium of world-class academic institutions that we believe will accelerate our endometriosis product development. Operationally, we reduced our cash utilization by $3.9 million compared to the first quarter of 2022 without sacrificing progress on our most strategic priorities. I am encouraged by our progress on all strategic fronts and look forward to continuing to deliver on our Growth, Innovation, and Operational Excellence initiatives."
Recent Corporate Highlights
Highlights of Second Quarter 2022 vs. Second Quarter 2021
Highlights of Second Quarter 2022 vs. First Quarter 2022:
Balance Sheet Highlights
Conference Call and Webcast Details
Aspira will host a conference call with investors today at 8:30am Eastern Time to discuss financial results and provide a corporate update followed by a question-and-answer period.
Toll Free: | 1-877-407-4018 |
International: | 1-201-689-8471 |
Conference ID: | 13730747 |
Webcast: | https://viavid.webcasts.com/starthere.jsp?ei=1556156&tp_key=c5bafc5645 |
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. OVA1plus™ combines our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. Aspira GenetiX™ testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. The next generation of products in development include OvaWatch™ and EndoCheck™. 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 launch timing for OvaWatch; the expected results of the collaboration with Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Medical University of Lodz; the expected launch timing and sales and margin impacts of Aspira's agreement with BRL; and the Company's cash management for the remainder of 2022. 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 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 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 LDTs; 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; 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.
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) | ||||||||
June 30, | December 31, | |||||||
2022 | 2021 | |||||||
Assets | (Unaudited) | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 20,480 | $ | 37,180 | ||||
Accounts receivable | 1,112 | 1,027 | ||||||
Prepaid expenses and other current assets | 1,173 | 1,624 | ||||||
Inventories | 191 | 174 | ||||||
Total current assets | 22,956 | 40,005 | ||||||
Property and equipment, net | 438 | 464 | ||||||
Right-of-use assets | 315 | 346 | ||||||
Restricted cash | 250 | 250 | ||||||
Other assets | 57 | 14 | ||||||
Total assets | $ | 24,016 | $ | 41,079 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,374 | $ | 1,501 | ||||
Accrued liabilities | 5,059 | 5,299 | ||||||
Current portion of long-term debt | 283 | 201 | ||||||
Short-term debt | 260 | 779 | ||||||
Lease liability | 68 | 60 | ||||||
Total current liabilities | 7,044 | 7,840 | ||||||
Non-current liabilities: | ||||||||
Long-term debt | 2,536 | 2,718 | ||||||
Lease liability | 314 | 349 | ||||||
Total liabilities | 9,894 | 10,907 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Common stock, par value $0.001 per share, 150,000,000 shares authorized at June 30, 2022 and December 31, 2021; 112,296,388 and 112,138,741 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 112 | 112 | ||||||
Additional paid-in capital | 503,249 | 501,788 | ||||||
Accumulated deficit | (489,239 | ) | (471,728 | ) | ||||
Total stockholders' equity | 14,122 | 30,172 | ||||||
Total liabilities and stockholders' equity | $ | 24,016 | $ | 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 | Six Months Ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue: | |||||||||||||||
Product | $ | 2,018 | $ | 1,720 | $ | 3,853 | $ | 3,136 | |||||||
Genetics | 48 | 79 | 106 | 159 | |||||||||||
Total revenue | 2,066 | 1,799 | 3,959 | 3,295 | |||||||||||
Cost of revenue(1): | |||||||||||||||
Product | 1,036 | 839 | 1,893 | 1,494 | |||||||||||
Genetics | 64 | 264 | 139 | 502 | |||||||||||
Total cost of revenue | 1,100 | 1,103 | 2,032 | 1,996 | |||||||||||
Gross profit | 966 | 696 | 1,927 | 1,299 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development(2) | 1,410 | 1471 | 2,758 | 2,343 | |||||||||||
Sales and marketing(3) | 3,580 | 4,018 | 8,077 | 7,126 | |||||||||||
General and administrative(4) | 4,196 | 3,279 | 8,559 | 5,788 | |||||||||||
Total operating expenses | 9,186 | 8,768 | 19,394 | 15,257 | |||||||||||
Loss from operations | (8,220 | ) | (8,072 | ) | (17,467 | ) | (13,958 | ) | |||||||
Interest income (expense), net | (10 | ) | 3 | (28 | ) | (21 | ) | ||||||||
Other income (expense), net | (13 | ) | 995 | (16 | ) | 985 | |||||||||
Net loss | $ | (8,243 | ) | $ | (7,074 | ) | $ | (17,511 | ) | $ | (12,994 | ) | |||
Net loss per share - basic and diluted | $ | (0.07 | ) | $ | (0.06 | ) | $ | (0.16 | ) | $ | (0.12 | ) | |||
Weighted average common shares used to compute basic and diluted net loss per common share | 112,242,893 | 111,958,928 | 112,191,520 | 110,311,666 | |||||||||||
Non-cash stock-based compensation expense included in cost of revenue and operating expenses: | |||||||||||||||
(1) Cost of revenue | $ | 35 | $ | 54 | $ | 87 | $ | 88 | |||||||
(2) Research and development | 53 | 95 | 49 | 121 | |||||||||||
(3) Sales and marketing | 58 | 336 | 205 | 475 | |||||||||||
(4) General and administrative | 464 | 797 | 1,107 | 1,087 |