Aspira Women’s Health Reports Fourth Quarter and Full Year 2020 Financial Results
26 March 2021 - 7:20AM
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 fourth
quarter and year ended December 31, 2020.
“In a year dominated by the pandemic, we
delivered strong stock price appreciation, growth in revenue and
test volume, and financial stability. In addition, we strengthened
our team and board of directors. We are starting 2021 by announcing
an accelerated product launch of OVASight, a new strategic
partnership and increases in our sales footprint,” stated
Valerie Palmieri, President and CEO.
Recent Corporate Highlights
- Acceleration of Launch Date of OVASight to Fourth
Quarter 2021Aspira announced the acceleration of the
target launch date of OVASight to the fourth quarter of 2021 with
full national availability in 2022. This test allows physicians to
classify suspected benign masses as low or high risk for malignancy
to help guide clinical management. The test is specifically
designed for a population with a low prevalence of disease, and we
estimate it may reach approximately 1.2 million to
1.5 million additional women in the United States.
- Strategic Research Collaboration to Develop a Combined
Technology Product-Development of Highly Sensitive
and Specific Proteomic and Transcriptomics Early Detection Test For
Women With High-Risk Of Ovarian CancerAspira announced it
has entered into an agreement with Dana Farber Cancer Institute
(DFCI), Brigham and Women’s Hospital, and Medical University Lodz
to evaluate their jointly-developed novel microRNA (miRNA)
technology in combination with current Aspira technologies, for the
development of a highly sensitive and specific early detection test
for women with high-risk of ovarian cancer.
- New York Medicaid CoverageWe announced
coverage by New York State Medicaid – one of the larger Medicaid
populations in the U.S., covering 33% of the population in the
state. This is a significant add to serve this underserved
population in New York State, and this will bring our total covered
lives to approximately 179M or 54% of the U.S. population as of
April 1, 2021.
- FinancingOn February 8, 2021, the Company
completed an offering of Aspira common stock resulting in net
proceeds of approximately $48.4 million, including full exercise of
the underwriters option to purchase additional shares and after
giving effect to underwriting discounts but before expenses.
- Board UpdateAspira
announced the appointment of Nicole Sandford to its board of
directors. The board is now 71% female.
Quarter over Quarter Results
– Fourth Quarter 2020 versus Fourth Quarter 2019:
|
- |
Total product and genetics volumes were relatively flat at 3,937
units compared to 3,950 units in the fourth quarter of last
year |
|
- |
Total product and genetics revenue increased 11% to $1.4 million up
from $1.3 million in the fourth quarter of last year |
Year over
Year Results – Full Year of 2020 versus Full Year
2019:
|
- |
Total product and genetics volumes increased 7% to 13,864 units up
from 12,994 units in 2019 |
|
- |
Total product and genetics revenue increased 5% to $4.6 million up
from $4.4 million in 2019 |
Fourth Quarter Highlights:
- Total Product and genetics revenue was $1.446 million for the
three months ended December 31, 2020, compared to $1.239 million
for the third quarter 2020. The 17% sequential increase is
primarily due to an increase in OVA1plus test volume compared to
the prior quarter. Prior year fourth quarter total product and
genetics revenue was $1.306 million.
- The number of OVA1plus tests performed increased 7% to
approximately 3,849 OVA1plus tests during the three months ended
December 31, 2020, compared to approximately 3,596 OVA1plus tests
for the third quarter. This test volume increase was primarily due
to our continued investment in commercialization and a further
increase in patient doctor visits as patients have adjusted to the
COVID-19 environment. Prior year fourth quarter OVA1plus tests
performed was 3,854.
- Gross profit on OVA1plus product revenue was $695 thousand (50%
profit margin) for the fourth quarter 2020 compared to $547
thousand for the third quarter of 2020 (45% profit margin). Prior
year fourth quarter OVA1plus gross profit was $619 thousand (48%
profit margin).
- Research and development expenses for the fourth quarter 2020
were $734 thousand compared to $244 thousand the same period in
2019. This increase was primarily due to product development costs
related to OVASight, our third-generation serial monitoring
product, as well as investments in bioinformatics and Aspira
Synergy, a decentralized platform and cloud service
technology.
- Sales and marketing expenses for the fourth quarter 2020 were
$2.843 million compared to $2.076 million the same period in 2019.
This increase was primarily due to increased expenditures on
marketing to improve product awareness as well as investments in
personnel.
- General and administrative expenses for the fourth quarter 2020
were $2.728 million compared to $1.600 million for the same period
in 2019. This increase was primarily due to an increase in legal
expenditures, board of director fees, which included the cash
settlement of restricted stock units to defray tax liabilities
resulting from earlier-granted restricted stock units, and
headcount and personnel-related expenses in the fourth
quarter.
- The Company ended the year with approximately $16.6 million in
cash. Cash utilization in the fourth quarter of 2020 was $4.205
million, compared to $2.933 million in the prior year fourth
quarter.
- On February 8, 2021, the Company completed a public offering of
its common stock resulting in net proceeds of approximately $48.4
million, after giving effect to underwriting discounts but before
expenses.
Conference Call and
WebcastAspira will host a call today at 4:30 p.m. Eastern
Time to discuss results followed by a question and answer
period.
Thursday March 25th @
4:30pmETInvestors Dial: 877-407-4018 Int’l Investors
Dial: 201-689-8471 Conference ID: 13717832
Webcast:
http://public.viavid.com/index.php?id=144003
About Aspira Women’s Health
Inc.Aspira 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. OVA1®plus combines our FDA-cleared
products OVA1® and OVERA® to detect risk of ovarian malignancy in
women with adnexal masses. Aspira GenetiXSM 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 has expertise in cutting-edge
research to inform our next generation of products. Our focus is on
delivering products that allow healthcare providers to stratify
risk, facilitate early detection and optimize treatment plans.
Visit our website for more information about our
products at www.aspirawh.com.
Forward-Looking StatementsThis
press release contains forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties. All
statements other than statements of historical facts contained in
this press release are forward-looking statements. 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, 2019, as supplemented by the section entitled
“Risk Factors” in Aspira’s Quarterly Reports on Form 10-Q for the
quarters ended March 31, 2020 and September 30, 2020. 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 to reflect
events, new information or circumstances occurring after the date
of this press release, except as required by law.
Investor Relations
Contact:Ashley R. RobinsonLifeSci Advisors, LLCTel
617-535-7742
Aspira Women’s Health
Inc.Consolidated Balance Sheets(Amounts
in Thousands, Except Share and Par Value Amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2020 |
|
2019 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
16,631 |
|
|
$ |
11,703 |
|
|
Accounts receivable |
|
865 |
|
|
|
924 |
|
|
Prepaid expenses and other current assets |
|
1,077 |
|
|
|
758 |
|
|
Inventories |
|
30 |
|
|
|
25 |
|
|
Total current assets |
|
18,603 |
|
|
|
13,410 |
|
|
Property and equipment, net |
|
583 |
|
|
|
353 |
|
|
Right-of-use assets |
|
406 |
|
|
|
52 |
|
|
Other assets |
|
13 |
|
|
|
13 |
|
|
Total assets |
$ |
19,605 |
|
|
$ |
13,828 |
|
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
$ |
1,149 |
|
|
$ |
855 |
|
|
Accrued liabilities |
|
3,618 |
|
|
|
2,588 |
|
|
Current portion long-term debt |
|
999 |
|
|
|
193 |
|
|
Short-term debt |
|
611 |
|
|
|
303 |
|
|
Lease liability |
|
23 |
|
|
|
39 |
|
|
Total current liabilities |
|
6,400 |
|
|
|
3,978 |
|
|
Non-current liabilities: |
|
|
|
|
|
|
Long-term debt |
|
3,077 |
|
|
|
1,099 |
|
|
Lease liability |
|
409 |
|
|
|
13 |
|
|
Total liabilities |
|
9,886 |
|
|
|
5,090 |
|
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, par value $0.001 per share, 150,000,000 shares
authorized at December 31,2020 and December 31, 2019;
104,619,876 and 97,286,157 shares issued and outstanding atDecember
31, 2020 and December 31, 2019, respectively |
|
105 |
|
|
|
97 |
|
|
Additional paid-in capital |
|
449,680 |
|
|
|
430,802 |
|
|
Accumulated deficit |
|
(440,066 |
) |
|
|
(422,161 |
) |
|
Total stockholders’ equity |
|
9,719 |
|
|
|
8,738 |
|
|
Total liabilities and stockholders’ equity |
$ |
19,605 |
|
|
$ |
13,828 |
|
|
Aspira Women’s Health
Inc.Consolidated Statements of
Operations(Amounts in Thousands, Except Share and Per
Share Amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December |
|
Year Ended December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
Product |
$ |
1,402 |
|
|
$ |
1,284 |
|
|
$ |
4,530 |
|
|
$ |
4,404 |
|
Genetics |
|
44 |
|
|
|
22 |
|
|
|
108 |
|
|
|
22 |
|
Service |
|
- |
|
|
|
2 |
|
|
|
13 |
|
|
|
112 |
|
Total revenue |
|
1,446 |
|
|
|
1,308 |
|
|
|
4,651 |
|
|
|
4,538 |
|
Cost of revenue(1): |
|
|
|
|
|
|
|
|
|
|
|
Product |
|
707 |
|
|
|
665 |
|
|
|
2,500 |
|
|
|
2,378 |
|
Genetics |
|
504 |
|
|
|
58 |
|
|
|
898 |
|
|
|
295 |
|
Service |
|
4 |
|
|
|
69 |
|
|
|
17 |
|
|
|
670 |
|
Total cost of revenue |
|
1,215 |
|
|
|
792 |
|
|
|
3,415 |
|
|
|
3,343 |
|
Gross profit |
|
231 |
|
|
|
516 |
|
|
|
1,236 |
|
|
|
1,195 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development(2) |
|
734 |
|
|
|
244 |
|
|
|
2,104 |
|
|
|
1,018 |
|
Sales and marketing(3) |
|
2,843 |
|
|
|
2,076 |
|
|
|
8,843 |
|
|
|
9,645 |
|
General and administrative(4) |
|
2,728 |
|
|
|
1,600 |
|
|
|
8,270 |
|
|
|
5,810 |
|
Total operating expenses |
|
6,305 |
|
|
|
3,920 |
|
|
|
19,217 |
|
|
|
16,473 |
|
Loss from operations |
|
(6,074 |
) |
|
|
(3,404 |
) |
|
|
(17,981 |
) |
|
|
(15,278 |
) |
Interest income, net |
|
(4 |
) |
|
|
20 |
|
|
|
10 |
|
|
|
59 |
|
Other income (expense), net |
|
(3 |
) |
|
|
(3 |
) |
|
|
66 |
|
|
|
(18 |
) |
Net loss |
$ |
(6,081 |
) |
|
$ |
(3,387 |
) |
|
$ |
(17,905 |
) |
|
$ |
(15,237 |
) |
Net loss per share - basic and diluted |
$ |
(0.58 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares used to computebasic and diluted net
loss per common share |
|
10,423,070 |
|
|
|
97,253,311 |
|
|
|
100,723,303 |
|
|
|
86,595,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expenseincluded in cost of
revenue and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
(1) Cost of revenue |
$ |
33 |
|
|
$ |
21 |
|
|
$ |
106 |
|
|
$ |
78 |
|
(2) Research and development |
|
17 |
|
|
|
— |
|
|
|
34 |
|
|
|
4 |
|
(3) Sales and marketing |
|
112 |
|
|
|
31 |
|
|
|
228 |
|
|
|
124 |
|
(4) General and administrative |
|
265 |
|
|
|
248 |
|
|
|
1,180 |
|
|
|
986 |
|
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