Full Press Release Details
Genetics Announces Third Quarter 2015 Financial Results
Provides Company Update
Conference Call to be Held Today at 4:30
SEATTLE, November 12, 2015 - Atossa Genetics Inc.
(NASDAQ: ATOS) today announced third quarter 2015 financial results and provided an update on recent company developments.
Dr. Steven C. Quay, Chairman, CEO & President, commented,
"We are very pleased with our ongoing progress in establishing our two Phase II pharmaceutical clinical programs, topical
Afimoxifene Gel and intraductal fulvestrant, both of which have extensive patent portfolios. Today we are announcing that the National
Cancer Institute has approved protocol development for a study to be funded by them using Afimoxifene Gel in their Cancer Prevention
Clinical Trials Program. With respect to intraductal fulvestrant, we are on track to commence the study in women with ductal carcinoma
in situ, or DCIS, during December 2015."
Dr. Quay added, "We are taking a number of steps to address
recent adverse changes in Medicare reimbursement for our pharmacogenomics test and to improve our pharmacogenomics test revenue,
including the recent addition of additional sales personnel, targeting conditions and drugs that provide a higher rate of reimbursement,
and enhancing sales incentives to drive sales volume."
Concluding, Dr. Quay commented, "We have much to look
forward to in the last quarter of 2015 and into 2016. Our Phase II pharmaceutical development programs are expected to produce
a number of value-creating milestones over the next six months for our shareholders
Recent Corporate Developments
Important recent corporate developments include the following:
Third Quarter 2015 Financial Results
For the three months and nine months ended September 30, 2015,
we had total net revenue of $772,244 and $5,339,669, respectively, consisting of pharmacogenomics testing, compared to $3,426 and
$37,425 of revenue in the same periods in 2014, which consisted of additional cash collections on NAF cytology tests performed
in 2013. Our pharmacogenomics test was launched in the fourth quarter of 2014 and we did not generate revenue in 2014 prior to
that. In March 2015, we introduced the FullCYTE Breast Aspirator in the U.S. and the ForeCYTE Breast Aspirator in the EU; however,
we have not generated any revenue in 2015 from sales of these products.
For the three months and nine months ended September 30, 2015,
gross profit totaled $458,838 and $1,963,598, respectively, which was attributable to pharmacogenomics testing, compared to $3,426
and $37,425, in the same period in 2014. Total cost of revenue for the three months and nine months ended September 30, 2015 was
$313,406 and $3,376,071, respectively, consisting of costs relating to pharmacogenomics testing services; there was no cost of
revenue during the same periods in 2014 as the only revenue generated during those periods was from additional cash collections
on NAF cytology tests performed in 2013.
For the three months ended September 30, 2015, total operating
expenses were $4,846,294, consisting of general and administrative (G&A) expenses of $3,017,909, research and development (R&D)
expenses of $1,090,349, and selling expenses of $738,036, representing an increase of $1,597,613, or 49% from $3,248,681 in the
same period in 2014, consisting of G&A expenses of $2,043,138, R&D expenses of $923,169, and selling expenses of $282,374.
Operating expenses for the nine months ended September 30, 2015 were $12,828,874 consisting of G&A expenses of $8,413,891,
R&D expenses of $2,398,032, and selling expenses of $2,016,951. Operating expenses increased $3,948,736, or 44% from $8,880,138
for the same period in 2014 consisting of $6,280,102 in G&A expenses, $1,856,439 in R&D expenses, and $743,597 in selling
The increase in selling expenses is mainly due to increases
in compensation expenses, travel, and advertisement as a result of the ForeCYTE and FullCYTE launch in Europe and the United States.
We expect that our selling expenses will continue to increase during 2015, as we build a sales force in the United States to support
primarily the services offered by the NRLBH, pharmacogenomics tests and potentially other tests.
G&A expenses consist primarily of personnel and related
benefit costs, facilities, professional services, insurance, and public company related expenses. The increase in G&A expenses
is mainly due to an increase in compensation expenses, professional fees, and recruiting fees as we increased our headcount to
support the launch of our new products. The increase also reflects an increase in bad debt expenses as a result of significant
increases in revenue and also higher than expected denials on non-Medicare appeals from prior periods.
We expect our G&A and selling expenses to continue to grow
throughout 2015 as we hire additional administrative and manufacturing personnel to support the increased sales and operating activities
as we promote, market and sell our pharmacogenomics testing and our other products and services under development.
The increase in R&D expenses is attributed to additional
R&D expenditures on the launch and development of ForeCYTE and FullCYTE in the first quarter of 2015. We expect that our R&D
expenditures will continue to grow as we develop our new products and tests in the pipeline, including Afimoxifene Gel, our intraductal
microcatheters and our NextCYTE test and other laboratory tests we may develop. We will add additional full-time employees and
incur additional costs to continue the development of our products and services under development, including the development of
our potential pharmaceuticals and conducting clinical studies.
Conference Call Information
Management will host a conference call on Thursday, November
12, 2015 at 4:30 pm eastern time to review financial results and corporate highlights. Following management's formal remarks, there
will be a question and answer session.
To listen to the call by phone, interested
parties within the U.S. should call 1-866-652-5200 and
International callers should call 1-412-317-6060.
All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast
at www.atossagenetics.com. Details for the webcast may be found on the Company's IR events page at http://ir.atossagenetics.com/ir-calendar.
A replay of the call will be available
approximately one hour after the end of the call through December 12, 2015. The replay can be accessed via Atossa's website or
by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through
the development of pharmaceuticals to treat breast health conditions and through the commercialization of medical devices and laboratory
services. The laboratory services are being developed by its subsidiary, The National Reference Laboratory for Breast Health Inc.
The laboratory's services and the Company's medical devices are being developed so they can be used as companions to therapeutics
to treat various breast health conditions. For more information, please visit www.atossagenetics.com.
Forward-Looking Statements
Forward-looking statements in this press release are subject
to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results,
including the risks and uncertainties associated with actions by the FDA, the outcome or timing of regulatory approvals needed
by Atossa to sell its products, responses to regulatory matters, including recalls of products, Atossa's ability to achieve its
objectives, successfully complete clinical studies, continue to manufacture and sell its products, and the safety and efficacy
of Atossa's products and services, performance of distributors, whether Atossa can launch and commercialize in the United States
and foreign markets the additional tests, devices and therapeutics in its pipeline in a timely and cost effective manner, and other
risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation
its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time. Atossa does not undertake any obligation
to update any forward-looking statement.
Atossa Genetics Inc.
CFO and General Counsel
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 7,839,439 | $ | 8,500,718 | ||||
| Restricted cash | 275,000 | - | ||||||
| Accounts receivable, net | 1,055,059 | 297,958 | ||||||
| Prepaid expenses | 201,652 | 247,207 | ||||||
| Inventory, net | 170,860 | 39,788 | ||||||
| Total current assets | 9,542,010 | 9,085,671 | ||||||
| Furniture and equipment, net | 484,544 | 357,532 | ||||||
| Intangible assets, net | 1,768,812 | 1,920,645 | ||||||
| Deferred financing costs | 509,375 | 351,961 | ||||||
| Other assets | 52,649 | 48,193 | ||||||
| Total assets | $ | 12,357,390 | $ | 11,764,002 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,179,329 | $ | 594,357 | ||||
| Accrued expenses | 934,675 | 444,861 | ||||||
| Payroll liabilities | 1,156,000 | 1,056,705 | ||||||
| Short-term lease obligations | - | 76,025 | ||||||
| Other current liabilities | 22,601 | 42,228 | ||||||
| Total current liabilities | 3,292,605 | 2,214,176 | ||||||
| Deferred rent | 5,688 | 2,483 | ||||||
| Long-term lease obligations | - | 49,216 | ||||||
| Total liabilities | 3,298,293 | 2,265,875 | ||||||
| Stockholders' equity | ||||||||
| Preferred stock - $.001 par value; 10,000,000 shares authorized, 0 shares issued and outstanding | - | - | ||||||
| Common stock - $.001 par value; 75,000,000 shares authorized, 30,446,260 and 24,564,058 shares issued and outstanding | 30,446 | 24,564 | ||||||
| Additional paid-in capital | 55,001,918 | 44,648,103 | ||||||
| Accumulated deficit | (45,973,267 | ) | (35,174,540 | ) | ||||
| Total stockholders' equity | 9,059,097 | 9,498,127 | ||||||
| Total liabilities and stockholders' equity | $ | 12,357,390 | $ | 11,764,002 |
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF
| For the Three Months Ended September 30, | For The Nine Months Ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Net revenue | $ | 772,244 | $ | 3,426 | $ | 5,339,669 | $ | 37,425 | ||||||||
| Cost of revenue | 313,406 | - | 3,376,071 | - | ||||||||||||
| Gross profit | 458,838 | 3,426 | 1,963,598 | 37,425 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling | 738,036 | 282,374 | 2,016,951 | 743,597 | ||||||||||||
| Research and development | 1,090,349 | 923,169 | 2,398,032 | 1,856,439 | ||||||||||||
| General and administrative | 3,017,909 | 2,043,138 | 8,413,891 | 6,280,102 | ||||||||||||
| Total operating expenses | 4,846,294 | 3,248,681 | 12,828,874 | 8,880,138 | ||||||||||||
| Operating loss | (4,387,456 | ) | (3,245,255 | ) | (10,865,276 | ) | (8,842,713 | ) | ||||||||
| Other income (expense) | 69,345 | (140 | ) | 66,549 | (2,189 | ) | ||||||||||
| Loss before income taxes | (4,318,111 | ) | (3,245,395 | ) | (10,798,727 | ) | (8,844,902 | ) | ||||||||
| Income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (4,318,111 | ) | $ | (3,245,395 | ) | $ | (10,798,727 | ) | $ | (8,844,902 | ) | ||||
| Loss per common share - basic and diluted | $ | (0.15 | ) | $ | (0.13 | ) | $ | (0.39 | ) | $ | (0.37 | ) | ||||
| Weighted average shares outstanding, basic & diluted | 28,766,012 | 24,537,379 | 27,500,855 | 23,860,843 |