Aspira Women’s Health Reports First Quarter 2024 Financial Results
15 May 2024 - 9:30PM
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 first quarter ended March 31, 2024.
“Our continued focus on growth, innovation and operational
excellence has positioned us for an exciting year,” said Nicole
Sandford, Chief Executive Officer of Aspira. “We saw OvaWatch®
volume grow 114% this quarter when compared to the first quarter of
last year, and we continued our two-year trend of cost reductions
across the company. Moreover, the price volatility we anticipated
following the introduction of OvaWatch in 2022 never materialized,
and our gross margin remains strong.”
“OvaWatch offers an incredible opportunity for our growth,
especially now that its features have been expanded to allow for
repeat testing at provider-prescribed intervals. Moreover, clinical
evidence to support the use of OvaWatch is stronger than ever.
Recent publications showed that clinicians may have been able to
avoid surgery for a majority of women with low- or indeterminate
ovarian cancer risk if OvaWatch had been used as part of clinical
decision-making. This one-of-a-kind tool offers clear benefits to
patients, providers and payers alike, and is poised to improve
outcomes for patients that choose to delay or avoid surgery in
favor of a watchful waiting approach.”
“Our team is more prepared than ever to take advantage of the
expanded commercially available OvaSuite test portfolio. We saw
very strong signs of a return to growth now that our commercial
strategy has reached the execution phase. March was the strongest
month of the first quarter and that momentum carried into April,
the second largest volume month in company history.”
Recent Corporate Highlights
- Published a study that demonstrated OvaWatch significantly
improves patient selection for surgery in ovarian cancer
management. The study entitled: “Ovarian Cancer Surgical
Consideration is Markedly Improved by the Neural Network
Powered-MIA3G Multivariate Index Assay,” evaluated 785 surgical
results in women with an adnexal mass. Results demonstrated that
the use of OvaWatch would have reduced the number of surgeries by
62% overall, and by 77% in pre-menopausal women. Had physicians
utilized OvaWatch scores for surgery selection, results
demonstrated a 431% improvement in the ability to predict
malignancy.
- Published a study of 500 women validating the use of OvaWatch
as a tool to monitor adnexal masses over time. The study, entitled
“Neural Network-derived Multivariate Index Assay Demonstrates
Effective Clinical Performance in Longitudinal Monitoring of
Ovarian Cancer Risk,” found serial testing with OvaWatch to be a
useful clinical tool in monitoring cancer risk of an adnexal
mass.
- Enhanced the Company’s commercial offering with the formal
launch of the longitudinal monitoring feature of OvaWatch. The new
feature offers physicians a tool for assessing malignancy risk over
time and determining the appropriate personalized treatment path.
OvaWatch utilizes an AI-powered algorithm to assess malignancy risk
of adnexal masses when initial clinical assessment indicates the
mass is indeterminant or low-risk.
- Announced a new agreement with Anthem Blue Cross in California
for reimbursement coverage of the Company’s OvaSuite portfolio of
risk assessment tests effective June 1, 2024. Anthem Blue Cross
will provide coverage for its commercial and government lines of
business, including Medicare Advantage and Medicaid, which
represents a total of approximately six million covered lives in
California. The Company was credentialed by Anthem during the first
quarter of 2024, allowing for its affiliates to partner with
Aspira, and more contracts are expected to follow.
First Quarter 2024 Financial Highlights
- Product revenue was $2.2 million for the three months ended
March 31, 2024, compared to $2.3 million for the same period in
2023. The number of OvaSuite tests performed was approximately
5,829 during the three months ended March 31, 2024, a 7% decrease
compared to the approximately 6,259 OvaSuite tests for the same
period in 2023. The average unit price (AUP) for the Company’s
OvaSuite tests was $369 for the three months ended March 31, 2024,
compared to $370 for the same period in 2023. Sales efficiency, as
measured by volume per full-time sales representative, increased
22% in the first quarter compared to the same period in 2023.
- Gross profit margin was 56% for the three months ended March
31, 2024, compared to 51% for the same period in 2023.
- Research and development expenses for the three months ended
March 31, 2024, were $0.9 million, a decrease of 28% compared to
$1.3 million for the same period in 2023. This decrease was
primarily due to decreases in personnel costs.
- Sales and marketing expenses for the three months ended March
31, 2024, were $1.9 million, a decrease of 27%, compared to $2.6
million for the same period in 2023. This decrease was primarily
due to decreased consulting, personnel, and travel costs.
- General and administrative expenses for the three months ended
March 31, 2024, were $3.1 million, a decrease of 13%, compared to
$3.6 million for the same period in 2023. This decrease was
primarily due to a decrease in personnel costs, as well as outside
accounting and consulting costs.
Balance Sheet HighlightsAs of March 31, 2024,
Aspira had $3.7 million in cash, including restricted cash, up from
$2.9 million in cash, including restricted cash as of December 31,
2023. Aspira raised $5.6 million in gross proceeds in a registered
direct offering during the first quarter 2024. Cash used in
operating activities was $4.4 million for the three months ended
March 31, 2024, compared to $5.7 million in the same period in
2023, a 22% decrease. The Company’s operating cash utilization
target for 2024 remains between $15 million and $18 million.
Conference Call and Webcast DetailsAspira’s
management team will host a conference call beginning at 8:30 am ET
today, May 15, 2024. Investors and other interested parties may
participate in the conference call by dialing 1-877-407-4018. The
call will be available via webcast by clicking HERE or on the
events page of the Company’s website after the conclusion of the
call.
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 comprised 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
may contain forward-looking statements that are made pursuant to
the safe harbor provisions of the federal securities laws,
including those relating to the timing and completion of any
products in the pipeline development and other statement 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 and
subsequent Quarterly Reports on Form 10-Q. We are providing this
information as of the date of this press release and do not
undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future
events or otherwise, except as required by law.
Investor Relations
Contact: Torsten Hombeck, Ph.D. Chief Financial
Officer Aspira Women’s Health Investors@aspirawh.com
Condensed Consolidated Balance Sheets
(unaudited) |
(Amounts in Thousands, Except Share and Par Value Amounts) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2024 |
|
2023 |
Assets |
(Unaudited) |
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
3,413 |
|
|
$ |
2,597 |
|
Accounts receivable, net of reserves of $2 and $15, as of March 31,
2024 and December 31, 2023, respectively |
|
1,531 |
|
|
|
1,459 |
|
Prepaid expenses and other current assets |
|
942 |
|
|
|
997 |
|
Inventories |
|
236 |
|
|
|
227 |
|
Total current assets |
|
6,122 |
|
|
|
5,280 |
|
Property and equipment,
net |
|
131 |
|
|
|
165 |
|
Right-of-use assets |
|
620 |
|
|
|
528 |
|
Restricted cash |
|
260 |
|
|
|
258 |
|
Other assets |
|
31 |
|
|
|
31 |
|
Total assets |
$ |
7,164 |
|
|
$ |
6,262 |
|
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
1,643 |
|
|
$ |
1,261 |
|
Accrued liabilities |
|
2,797 |
|
|
|
2,863 |
|
Current portion of long-term debt |
|
249 |
|
|
|
166 |
|
Short-term debt |
|
416 |
|
|
|
670 |
|
Current maturities of lease liabilities |
|
188 |
|
|
|
159 |
|
Total current liabilities |
|
5,293 |
|
|
|
5,119 |
|
Non-current liabilities: |
|
|
|
|
|
Long-term debt |
|
1,347 |
|
|
|
1,430 |
|
Non-current maturities of lease liabilities |
|
487 |
|
|
|
427 |
|
Warrant liabilities |
|
1,400 |
|
|
|
1,651 |
|
Total liabilities |
|
8,527 |
|
|
|
8,627 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
Common stock, par value $0.001
per share, 200,000,000 and 150,000,000 shares authorized at March
31, 2024 and December 31, 2023, respectively; 12,344,104 and
10,645,049 shares issued and outstanding at March 31, 2024 and
December 31, 2023, respectively |
|
12 |
|
|
|
11 |
|
Additional paid-in capital |
|
521,557 |
|
|
|
515,927 |
|
Accumulated deficit |
|
(522,932 |
) |
|
|
(518,303 |
) |
Total stockholders’ deficit |
|
(1,363 |
) |
|
|
(2,365 |
) |
Total liabilities and stockholders’ deficit |
$ |
7,164 |
|
|
$ |
6,262 |
|
Aspira Women’s Health Inc. |
Condensed Consolidated Statements of Operations
(unaudited) |
(Amounts in Thousands, Except Share and Per Share Amounts) |
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2024 |
|
2023 |
Revenue: |
|
|
|
|
|
Product |
$ |
2,153 |
|
|
$ |
2,315 |
|
Genetics |
|
- |
|
|
|
1 |
|
Total revenue |
|
2,153 |
|
|
|
2,316 |
|
Cost of revenue: |
|
|
|
|
|
Product |
|
939 |
|
|
|
1,130 |
|
Total cost of revenue |
|
939 |
|
|
|
1,130 |
|
Gross profit |
|
1,214 |
|
|
|
1,186 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
906 |
|
|
|
1,267 |
|
Sales and marketing |
|
1,889 |
|
|
|
2,595 |
|
General and administrative |
|
3,129 |
|
|
|
3,604 |
|
Total operating expenses |
|
5,924 |
|
|
|
7,466 |
|
Loss from operations |
|
(4,710 |
) |
|
|
(6,280 |
) |
Other income (expense),
net: |
|
|
|
|
|
Change in fair value of warrant liabilities |
|
251 |
|
|
|
(24 |
) |
Interest (expense) income, net |
|
(5 |
) |
|
|
26 |
|
Other expense, net |
|
(165 |
) |
|
|
(300 |
) |
Total other income (expense), net |
|
81 |
|
|
|
(298 |
) |
Net loss |
$ |
(4,629 |
) |
|
$ |
(6,578 |
) |
Net loss per share - basic and
diluted |
$ |
(0.39 |
) |
|
$ |
(0.79 |
) |
Weighted average common shares
used to compute basic and diluted net loss per common share |
|
11,846,075 |
|
|
|
8,313,091 |
|
|
|
|
|
|
|
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