Aspira Women’s Health Reports Fourth Quarter and Full Year 2023 Financial Results
28 März 2024 - 12:30PM
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 to 57.6% for the same period in
2022.
- Research and development expenses for the three months ended
December 31, 2023, increased by $0.1 million, or 7%, compared to
the same period in 2022.
- Sales and marketing expenses for the three months ended
December 31, 2023, decreased by $1.1 million, or 40%, 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, or 4%, 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. The
15% 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 to 52.8% 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, or 32%, 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, or 48%, 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, or 16%, 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 $2.9 million in cash,
including restricted cash. Subsequent to the end of the quarter,
Aspira raised $5.5 million in gross proceeds in a registered direct
offering and concurrent private placement. Cash used in operating
activities was $3.5 million for the three months ended December 31,
2023, compared to $7.1 million in the same period in 2022. Cash
used in operating activities for the year ended December 31, 2023,
was $15.9 million, a 49% decrease compared to $31.1 million in the
same period in 2022.
Conference Call and Webcast DetailsAspira 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
ET877-407-4018201-689-8471Click HERE |
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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 99% and is used to
assess ovarian cancer risk for women where initial clinical
assessment indicates the mass is indeterminate or benign, and thus
surgery may be premature or unnecessary. Ova1Plus is a reflex
process of two FDA-cleared tests, Ova1® and Overa®, to assess the
risk of ovarian malignancy in women planned for surgery.
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 StatementsThis 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 $15 and $9, at September
30, 2023 and December 31, 2022, respectively |
|
|
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 $0.001 per share, 200,000,000 and 150,000,000
shares authorized at December 31, 2023 and December 31, 2022,
respectively; 10,645,049 and 8,306,326 shares issued and
outstanding at December 31, 2023 and December 31, 2022,
respectively |
|
|
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 |
|
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