Vermillion: Aspira Women’S Health Reports

The following excerpt is from the company's SEC filing.
Third Quarter 2021 Financial Results
Total Revenue Increased 34% to $1.67
 million
; OVA1 Volume Grew 19% to 4,281 Units
Successful Completion of Proof of Concept with Harvard Dana Farber Cancer Institute Collaboration
Achieved Over 194 Million Covered Lives for OVA1
Conference Call and Webcast Today at 8:30 a.m. ET
AUSTIN, Texas —
November 
10, 2021
 — 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 Lives
We increased covered lives during the third quarter to a total of over 194
. This is an 8% increase from our base of approximately 179
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
covered lives, and we believe inclusion in the AIM and eviCore guidelines provides us with further validation and credibility in our discussions with
health plans.
Medicaid Coverage
We 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
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 Concept
We 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 Today
In 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 Progress
We 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
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
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
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 
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
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
in unrestricted cash.  Cash used in operations in the third quarter of 2021 was $7.9
compared to $3.1
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:
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
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.
30, 2021 increased by $47,000, or 3%, compared to the second quarter of 2021.
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.
30, 2021 increased by $560,000, or 17%, compared to the second quarter of 2021. 
compared to $6.5
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.
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
bout 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 Statements
This 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
. 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. Robinson
LifeSci Advisors, LLC
Tel 617-535-7742
Condensed Consolidated Balance Sheets
(Amounts in Thousands, Except Share and Par Value Amounts)
(Unaudited)
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 

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 

366 

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
30, 2021 and
31, 2020; 112,100,049 and 104,619,876 shares issued and outstanding at
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
Condensed Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
Three Months Ended
Nine Months Ended
Revenue:
1,614 

1,217 

4,748 

3,128 

Genetics
49 

22 

208 

64 

Service
Total revenue
1,666 

1,239 

4,961 

3,205 

Cost of revenue
694 

670 

2,167 

1,793 

223 

133 

746 

394 

Total cost of revenue
917 

807 

2,913 

2,200 

749 

432 

2,048 

1,005 

Operating expenses:
1,518 

595 

3,861 

1,370 

5,083 

2,152 

12,209 

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)

(35)

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
20 

73 

(2)  Research and development
115 

16 

235 

(3)  Sales and marketing
367 

843 

116 

(4)  General and administrative
646 

343 

1,734 

915 

The above information was disclosed in a filing to the SEC. To see the filing, click here.

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