Aspira Women’s Health Reports Third Quarter 2021 Financial Results
11 November 2021 - 12:00AM
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 third quarter
ended September 30, 2021.
“We are very pleased with the growth in positive
medical policy coverage with the addition of AIM Specialty
Health’s Clinical Appropriateness Guidelines and Medicaid coverage
and credentialing for OVA1. In addition, in spite of renewed
COVID-19 restrictions we were able to grow in specific markets,”
indicated Valerie Palmieri, Aspira’s Chief Executive Officer. “We
are also making positive progress on our product collaboration with
the Dana Farber Cancer Institute with the successful completion of
the Phase 1 of our proof of concept study relating to our
OvaInherit trial. We had continued positive dialogue with the Food
and Drug Administration regarding our planned EndoCheck product and
expect resolution on our optimal regulatory path forward for
Endocheck by the end of the year.”
Recent Corporate Highlights
- Coverage for OVA1®
Increased to over 194 Million Covered LivesWe increased
covered lives during the third quarter to a total of over 194
million. This is an 8% increase from our base of approximately 179
million covered lives as of April 1, 2021. The Company’s OVA1 test,
a pelvic mass risk assessment for ovarian cancer, has been
determined to be medically necessary according to AIM Specialty
Health’s Clinical Appropriateness Guidelines in addition to the
eviCore Guidelines. Our market access strategy made significant
progress with reaching over 194 million covered lives, and we
believe inclusion in the AIM and eviCore guidelines provides us
with further validation and credibility in our discussions with
ALL health plans.
- Medicaid
CoverageWe are now credentialed in the top 5 states by
Medicaid population for OVA1, including California, New York,
Texas, Florida, and Pennsylvania, bringing the total credentialed
national Medicaid population to nearly 61 million Medicaid lives,
which represents approximately 77% of the U.S. Medicaid
population.
- Collaboration with Harvard
Dana Farber Cancer Institute miRNA Technology Passes Phase 1 Proof
of ConceptWe have completed with the teams at Dana Farber
Cancer Institute, Brigham and Women’s Hospital and Medical
University of Lodz the Phase 1 of the Proof of Concept evaluation.
The evaluation surpassed all required metrics and based on the
outcome of the evaluation, the Aspira Innovation team along with
the collaborators from the institutions have begun implementing
Phase 2. With the first critical stage gate passed, we are
proceeding to evaluate the combined potential impact of our protein
biomarker algorithms and the miRNA technology in the development of
a combined technology and platform which we
believe may set the foundation for a high risk ovarian
cancer screening application, which is branded as our OvaInherit
trial.
-
Publication in Third Quarter Demonstrates OVA1 Superiority
Versus CA125, the Most Common Ovarian Cancer Risk Assessment Used
TodayIn a special ovarian cancer edition, Diagnostics,
published a paper entitled “Salvaging Detection of Early-Stage
Ovarian Malignancies When CA125 Is Not Informative.” In a
retrospective study of 2,305 patients, OVA1 detected over 50% of
ovarian malignancies in premenopausal women of all cancer
stages, that CA125 would have missed. OVA1 also correctly
identified 63% of early-stage cancers missed by CA125. This paper
further validates and supports the superior early-stage risk
detection of ovarian cancer of OVA1 versus CA125 in a large
population.
- OvaSight
Development ProgressWe have determined that we will
be branding the OvaSight test as OvaWatch which we
believe is more descriptive of the utility of the
test. The test was developed through a rigorous
scientific and clinical-based process based on data from
our New York State laboratory developed tests (LDT) and from
our FDA regulatory process in 3,000 patients. We will be performing
additional scientific and market review with the intent to
refine the intended use for OvaWatch.
Financial Highlights
- Quarter over Quarter
Results – Third Quarter of 2021 versus Third Quarter of
2020:
- Total product and genetics revenue
increased 34% to $1,663,000 up from $1,239,000
- Total product and genetics volumes
increased 20% to 4,386 units up from 3,660 units
- Quarter over Quarter Results
– Third Quarter 2021 versus Second Quarter 2021:
- Total product and genetics revenue
decreased 7% to $1,663,000 down from $1,797,000 in the second
quarter of this year.
- Total product and genetics volumes
decreased 7% to 4,386 units down from 4,708 units in the second
quarter of this year.
Highlights of Third Quarter 2021 vs.
Third Quarter 2020:
- Product revenue was $1,614,000 for
the three months ended September 30, 2021, compared to $1,217,000
for the same period in 2020, an increase of 33%.
- The number of OVA1plus tests
performed increased 19% to 4,281 OVA1plus tests during the three
months ended September 30, 2021, compared to 3,596 OVA1plus tests
for the same period in 2020.
- The revenue per OVA1plus test
performed increased to approximately $377 compared to $338 for the
same period in 2020, an increase of 11%. This increase was
primarily driven by an increase in payments by contracted payers
and improved collections.
- Gross profit margin for OVA1plus
was 57% in the third quarter compared to 45% in the third quarter
of 2020. The year on year increase was driven by volume
improvement.
- Research and development expenses
for the three months ended September 30, 2021 increased by
$923,000, or 155%, compared to the same period in 2020. This
increase was primarily due to clinical utility and product
development costs related to OVASight, as well as investments in
bioinformatics, investments in Aspira Synergy and consulting
expenses associated with EndoCheck regulatory clearance.
- Sales and marketing expenses for
the three months ended September 30, 2021 increased by
$2,931,000, or 136%, compared to the same period in 2020. This
increase was primarily due to increased personnel, consulting and
recruiting costs.
- General and administrative expenses
for the three months ended September 30, 2021 increased by
$1,873,000 or 95%, compared to the same period in 2020. This
increase was primarily due to an increase in stock compensation
expenses, headcount, and personnel expenses.
- We ended the third quarter with
approximately $44.9 million in unrestricted cash. Cash used in
operations in the third quarter of 2021 was $7.9 million compared
to $3.1 million in the third quarter of 2020. This increase was
across all elements of operating expenses but primarily employment
costs and travel and entertainment as commercial travel in the
prior year was depressed due to COVID-19 pandemic related travel
restrictions.
Highlights of Third Quarter 2021 vs.
Second Quarter 2021:
- Product revenue was $1,614,000 for
the three months ended September 30, 2021, compared to $1,718,000
for the second quarter of 2021, a decrease of 6%.
- The number of OVA1plus tests
performed decreased 6% to 4,281 OVA1plus tests during the three
months ended September 30, 2021, compared to 4,553 OVA1plus tests
for the second quarter of 2021.
- The revenue per OVA1plus test
performed remained flat at approximately $377 compared to the
second quarter of 2021.
- Gross profit margin for OVA1plus
was 57% in the third quarter compared to 52% in the second quarter
of 2021.
- Research and development expenses
for the three months ended September 30, 2021 increased by
$47,000, or 3%, compared to the second quarter of 2021.
- Sales and marketing expenses for
the three months ended September 30, 2021 increased by
$1,065,000, or 27%, compared to the second quarter of 2021. The
increase was primarily driven by increases in personnel costs and
investments in marketing.
- General and administrative expenses
for the three months ended September 30, 2021 increased by
$560,000, or 17%, compared to the second quarter of
2021.
- We ended the third quarter with
approximately $44.9 million in unrestricted cash. Cash used in
operations in the third quarter of 2021 was $7.9 million compared
to $6.5 million in the second quarter of 2021. The increase was
primarily driven by new hires, consultants, marketing and
promotional activities as well as research and development spending
focused on EndoCheck.
Conference Call and Webcast
Aspira will host a call today at 8:30 a.m.
Eastern Time to discuss results followed by a question-and-answer
period.
Domestic: |
877-407-4018 |
International: |
201-689-8471 |
Conference ID: |
13724440 |
Webcast: |
https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/47156/indexl.html |
|
|
About Aspira Women’s Health
Inc.Aspira Women’s Health Inc. (formerly known as
Vermillion, Inc., Nasdaq: VRML) 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 more
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 are OVASight™, which we are rebranding as OvaWatch™,
and EndoCheck™. Visit our website for more information at
www.aspirawh.com.
Forward-Looking StatementsThis
press release contains forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, including
statements regarding expectations with respect to studies relating
to OvaInherit and plans with respect to OvaSight/OvaWatch,
including its rebranding, scientific and market review and launch
dates. 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, 2020, as supplemented by the section entitled
“Risk Factors” in Aspira’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2021. 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. RobinsonLifeSci Advisors, LLCTel:
617-535-7742
|
Aspira Women’s Health Inc. |
Condensed Consolidated Balance Sheets |
(Amounts in Thousands, Except Share and Par Value Amounts) |
(Unaudited) |
|
|
|
|
|
|
|
September 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
44,870 |
|
|
$ |
16,631 |
|
Restricted cash |
|
|
250 |
|
|
|
- |
|
Accounts receivable |
|
|
1,103 |
|
|
|
865 |
|
Prepaid expenses and other current assets |
|
|
828 |
|
|
|
1,077 |
|
Inventories |
|
|
137 |
|
|
|
30 |
|
Total current assets |
|
|
47,188 |
|
|
|
18,603 |
|
Property and equipment, net |
|
|
498 |
|
|
|
583 |
|
Right-of-use assets |
|
|
361 |
|
|
|
406 |
|
Other assets |
|
|
- |
|
|
|
13 |
|
Total assets |
|
$ |
48,047 |
|
|
$ |
19,605 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,155 |
|
|
$ |
1,103 |
|
Accrued liabilities |
|
|
4,998 |
|
|
|
3,618 |
|
Current portion of long-term debt |
|
|
200 |
|
|
|
645 |
|
Short-term debt |
|
|
- |
|
|
|
611 |
|
Lease liability |
|
|
56 |
|
|
|
23 |
|
Total current liabilities |
|
|
6,409 |
|
|
|
6,000 |
|
Non-current liabilities: |
|
|
|
|
|
|
Long-term debt |
|
|
2,768 |
|
|
|
3,477 |
|
Lease liability |
|
|
366 |
|
|
|
409 |
|
Total liabilities |
|
|
9,543 |
|
|
|
9,886 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, par value $0.001 per share, 150,000,000 shares
authorized at September 30, 2021 and December 31, 2020;
112,100,049 and 104,619,876 shares issued and outstanding at
September 30, 2021 and December 31, 2020, respectively |
|
|
112 |
|
|
|
105 |
|
Additional paid-in capital |
|
|
501,159 |
|
|
|
449,680 |
|
Accumulated deficit |
|
|
(462,767 |
) |
|
|
(440,066 |
) |
Total stockholders’ equity |
|
|
38,504 |
|
|
|
9,719 |
|
Total liabilities and stockholders’ equity |
|
$ |
48,047 |
|
|
$ |
19,605 |
|
Aspira Women’s Health Inc. |
Condensed Consolidated Statements of
Operations |
(Amounts in Thousands, Except Share and Per Share Amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
$ |
1,614 |
|
|
$ |
1,217 |
|
|
$ |
4,748 |
|
|
$ |
3,128 |
|
Genetics |
|
|
49 |
|
|
|
22 |
|
|
|
208 |
|
|
|
64 |
|
Service |
|
|
3 |
|
|
|
- |
|
|
|
5 |
|
|
|
13 |
|
Total revenue |
|
|
1,666 |
|
|
|
1,239 |
|
|
|
4,961 |
|
|
|
3,205 |
|
Cost of revenue(1): |
|
|
|
|
|
|
|
|
|
|
|
|
Product |
|
|
694 |
|
|
|
670 |
|
|
|
2,167 |
|
|
|
1,793 |
|
Genetics |
|
|
223 |
|
|
|
133 |
|
|
|
746 |
|
|
|
394 |
|
Service |
|
|
- |
|
|
|
4 |
|
|
|
- |
|
|
|
13 |
|
Total cost of revenue |
|
|
917 |
|
|
|
807 |
|
|
|
2,913 |
|
|
|
2,200 |
|
Gross profit |
|
|
749 |
|
|
|
432 |
|
|
|
2,048 |
|
|
|
1,005 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development(2) |
|
|
1,518 |
|
|
|
595 |
|
|
|
3,861 |
|
|
|
1,370 |
|
Sales and marketing(3) |
|
|
5,083 |
|
|
|
2,152 |
|
|
|
12,209 |
|
|
|
6,000 |
|
General and administrative(4) |
|
|
3,839 |
|
|
|
1,966 |
|
|
|
9,627 |
|
|
|
5,542 |
|
Total operating expenses |
|
|
10,440 |
|
|
|
4,713 |
|
|
|
25,697 |
|
|
|
12,912 |
|
Loss from operations |
|
|
(9,691 |
) |
|
|
(4,281 |
) |
|
|
(23,649 |
) |
|
|
(11,907 |
) |
Interest income (expense), net |
|
|
(14 |
) |
|
|
5 |
|
|
|
(35 |
) |
|
|
14 |
|
Other income (expense), net |
|
|
(2 |
) |
|
|
(11 |
) |
|
|
983 |
|
|
|
69 |
|
Net loss |
|
$ |
(9,707 |
) |
|
$ |
(4,287 |
) |
|
$ |
(22,701 |
) |
|
$ |
(11,824 |
) |
Net loss per share - basic and diluted |
|
$ |
(0.09 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.12 |
) |
Weighted average common shares used to compute basic and diluted
net loss per common share |
|
|
112,077,133 |
|
|
|
103,200,612 |
|
|
|
110,904,824 |
|
|
|
99,555,194 |
|
Non-cash stock-based compensation expense included in cost of
revenue and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
(1) Cost of revenue |
|
$ |
50 |
|
|
$ |
20 |
|
|
$ |
137 |
|
|
$ |
73 |
|
(2) Research and development |
|
|
115 |
|
|
|
16 |
|
|
|
235 |
|
|
|
17 |
|
(3) Sales and marketing |
|
|
367 |
|
|
|
31 |
|
|
|
843 |
|
|
|
116 |
|
(4) General and administrative |
|
|
646 |
|
|
|
343 |
|
|
|
1,734 |
|
|
|
915 |
|
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