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8-K - 8-K - Aspira Women's Health Inc.vrml-20180809x8k.htm

 

 

 

 

 

Exhibit 99.1

 

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Vermillion Reports Second Quarter 2018 Financial Results

Conference Call scheduled for today, August 9, 2018 at 4:30 p.m. ET

AUSTIN, Texas — August 9, 2018 — Vermillion, Inc. (NASDAQ: VRML), a bio-analytical solutions company focused on gynecologic disease, today reported its financial results for the second quarter ended June 30, 2018.



“We continue to make steady progress in our commercialization efforts and are pleased to see the fundamental building blocks in place.  With the sales force expansion, the hiring of Chris Goulart, SVP of Commercial Operations, and our new platform and portfolio enhancements, we believe we have the core ingredients in place for success,” said Valerie Palmieri, President and CEO of Vermillion. “We fundamentally believe in the ability of our OVA1 test to save lives and change the practice of medicine in women’s health.  Our two new product enhancements are key milestones that should advance the standard of care in ovarian cancer.”



Recent Corporate Developments and Upcoming Milestones



·

Finalizing launch plans for two new offerings:

o

A new platform and cloud service for decentralizing OVA1 testing. The platform and web service will allow OVA1 and its OVA Calc to be performed locally at hospital systems/integrated delivery networks, regional labs, & large OBGyn super groups. Decentralizing OVA1 allows for increased reach and access in the markets we serve with the goal of accelerating adoption.



o

A new clinical pathway offering OVA1/Overa Reflex.  OVA1/Overa Reflex is designed to improve accuracy and reduce false positives by nearly 40% by leveraging the strengths of each product: OVA1’s sensitivity and Overa’s specificity.  This new offering will also be available through a decentralized structure.




 

·

Named Mr. Chris Goulart as Senior Vice President of Commercial Operations, a newly created position focusing on the Company’s growth operations. Added three Senior Large Practice Sales professionals focused on our new platform and cloud service offering. The total number of sales representatives is now 11, all of whom will focus on our new platform in addition to our historical Gynecology practice targets. 



·

Completed an equity financing through the public offering of common and preferred stock on April 17, 2018, with net proceeds raised after offering expenses of $13.5 million. The financing enables the Company to drive its commercialization strategy for OVA1 in the U.S.





Q2 2018 Financial Results



·

Total revenue in the second quarter of 2018 was $708 thousand compared to $898 thousand in the prior year quarter.



·

Product revenue in the second quarter of 2018 totaled $627 thousand compared to $860 thousand in the prior year quarter, representing a 27% year-over-year decrease.  1,884 OVA1 tests were performed in the second quarter of 2018, versus 2,418 OVA1 tests performed in the prior year quarter. The revenue and volume decrease were attributable to the loss of a significant client bill customer in Q3 2017, as well as reductions in volume in uncovered territories. Despite these reductions, revenue associated with Medicare increased more than five-fold driven by a 19% increase in volume and a 440% increase in price. 



·

Revenue on a per-test-performed GAAP basis was $333 in the second quarter of 2018, representing a 15% increase over revenue per test performed on a comparable GAAP basis of $287 in the second quarter of 2017. (This second quarter 2017 GAAP amount reflects Vermillion’s first quarter 2018 adoption of a new revenue recognition accounting rule, so it differs from the $356 per-test-performed reported last year for the second quarter of 2017.)



·

Cost of product revenue in the second quarter of 2018 totaled $528 thousand, representing a 23% increase from the second quarter of 2017 due to increased postage and kits delivered to physicians, non-recurring lab supply costs for our new offerings and clinical validation, as well as Quest Diagnostics Incorporated project management fees incurred in 2018.




 

·

Total operating expenses in the second quarter of 2018 increased to $2.9 million compared to $2.6 million in the same year-ago quarter, representing an increase of 15%. The increase includes one-time costs for severance, increased consulting costs as well as increased investment in sales resources.



·

Net loss for the second quarter of 2018 was $3.0 million or $(0.04) per share, as compared to a net loss of $2.4 million or $(0.04) per share in the same year-ago quarter.



·

There were 75.3 million common shares outstanding at June 30, 2018.



·

Cash and cash equivalents at June 30, 2018 were $14.1 million.



·

The company utilized $2.5 million in cash in the second quarter of 2018, exclusive of the $13.5 million received from the April 2018 public offering net of issuance costs.  



Conference Call and Webcast

Vermillion’s President and CEO, Valerie Palmieri, will host a call today to discuss results followed by a question and answer period at 4:30 p.m. Eastern Time.



Thursday, August 9th @ 4:30pm Eastern Time

Domestic:800-239-9838

International:323-794-2551

Conference ID:5791297

Webcast:http://public.viavid.com/index.php?id=130234



Replays, Available through August 23rd:  

Domestic:844-512-2921

International:412-317-6671

Replay PIN:5791297





About Vermillion, Inc.


 

Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve gynecologic health outcomes for women. Vermillion, along with its prestigious scientific collaborators, discovers, develops, and delivers innovative diagnostic and technology tools that help women with serious diseases. The company's initial in vitro diagnostic test, OVA1® (MIA), was the first FDA cleared, protein-based In Vitro Diagnostic Multivariate Index Assay, and represented a new class of software-based liquid biopsy in vitro diagnostics. In March 2016, Vermillion received FDA clearance for Overa™, a Multivariate Index Assay 2nd Generation (MIA2G) test with significantly improved specificity and ease of use. Vermillions tests are intended to characterize and stage disease, and to help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, or to assist in monitoring response to therapy.



Forward-Looking Statement

This 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, including statements regarding Vermillion’s commercialization plans and the results thereof, expected results of the launch of the new platform and cloud service for decentralizing OVA1 testing, future test volumes and the anticipated activities of Vermillion’s sales representatives.  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 the risks and uncertainties inherent in Vermillion’s business, including those described in the section entitled “Risk Factors” in Vermillion’s Annual Report on Form 10-K for the year ended December 31, 2017.  The events and circumstances reflected in Vermillion’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements.  Vermillion 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. Robinson


 

LifeSci Advisors, LLC

Tel 617-535-7742

Arr@lifesciadvisors.com




 



Vermillion, Inc.

Consolidated Balance Sheets

(Amounts in Thousands, Except Share and Par Value Amounts)

(Unaudited)















 

 

 

 

 



June 30,

 

December 31,



2018

 

2017

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

14,135 

 

$

5,539 

Accounts receivable, net

 

707 

 

 

205 

Prepaid expenses and other current assets

 

334 

 

 

459 

Inventories

 

110 

 

 

102 

Total current assets

 

15,286 

 

 

6,305 

Property and equipment, net

 

835 

 

 

1,181 

Other assets

 

 -

 

 

11 

Total assets

$

16,121 

 

$

7,497 



 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

783 

 

$

745 

Accrued liabilities

 

1,686 

 

 

1,650 

Short-term debt

 

187 

 

 

185 

Other current liabilities

 

10 

 

 

29 

Total current liabilities

 

2,666 

 

 

2,609 

Non-current liabilities:

 

 

 

 

 

Long-term debt

 

1,387 

 

 

1,481 

Total liabilities

 

4,053 

 

 

4,090 

Commitments and contingencies

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock, par value $0.001 per share, 150,000,000 shares authorized at

 

 

 

 

 

June 30, 2018 and December 31, 2017; 75,274,251 and 60,036,017 shares

 

 

 

 

 

issued and outstanding at June 30, 2018 and December 31, 2017,

 

 

 

 

 

respectively

 

75 

 

 

60 

Additional paid-in capital

 

413,445 

 

 

399,400 

Accumulated deficit

 

(401,452)

 

 

(396,053)

Total stockholders’ equity

 

12,068 

 

 

3,407 

Total liabilities and stockholders’ equity

$

16,121 

 

$

7,497 




 

Vermillion, Inc.

Consolidated Statements of Operations

(Amounts in Thousands, Except Share and Per Share Amounts)

(Unaudited)









 

 

 

 

 

 

 

 

 

 

 



Three Months Ended June 30,

 

Six Months Ended June 30,



2018

 

2017

 

2018

 

2017

Revenue:

 

 

 

 

 

 

 

 

 

 

 

Product

$

627 

 

$

860 

 

$

1,240 

 

$

1,538 

Service

 

81 

 

 

38 

 

 

117 

 

 

86 

Total revenue

 

708 

 

 

898 

 

 

1,357 

 

 

1,624 

Cost of revenue:(1)

 

 

 

 

 

 

 

 

 

 

 

Product

 

528 

 

 

428 

 

 

1,061 

 

 

850 

Service

 

280 

 

 

266 

 

 

550 

 

 

571 

Total cost of revenue

 

808 

 

 

694 

 

 

1,611 

 

 

1,421 

Gross profit (loss)

 

(100)

 

 

204 

 

 

(254)

 

 

203 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development(2)

 

154 

 

 

268 

 

 

296 

 

 

493 

Sales and marketing(3)

 

1,478 

 

 

1,041 

 

 

2,703 

 

 

2,064 

General and administrative(4)

 

1,299 

 

 

1,241 

 

 

2,613 

 

 

2,648 

Total operating expenses

 

2,931 

 

 

2,550 

 

 

5,612 

 

 

5,205 

Loss from operations

 

(3,031)

 

 

(2,346)

 

 

(5,866)

 

 

(5,002)

Interest income (expense), net

 

(7)

 

 

(10)

 

 

(19)

 

 

(22)

Other income (expense), net

 

(11)

 

 

(4)

 

 

(14)

 

 

(9)

Net loss

$

(3,049)

 

$

(2,360)

 

$

(5,899)

 

$

(5,033)

Net loss per share - basic and diluted

$

(0.04)

 

$

(0.04)

 

$

(0.09)

 

$

(0.09)

Weighted average common shares used to compute basic and diluted net loss per common share

 

69,353,622 

 

 

56,113,917 

 

 

64,721,128 

 

 

55,123,977 

Non-cash stock-based compensation expense included in cost of revenue and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

(1)  Cost of revenue

$

28 

 

$

40 

 

$

58 

 

$

79 

(2)  Research and development

 

 

 

 

 

 

 

(3)  Sales and marketing

 

28 

 

 

40 

 

 

71 

 

 

77 

(4)  General and administrative

 

304 

 

 

295 

 

 

412 

 

 

510