Full Press Release Details
Announces Second Quarter 2015 Financial Results
Revenue for Q2 2015 of $2.7 Million
Conference Call to be Held Today at 4:30
SEATTLE, August 6, 2015 - Atossa Genetics Inc. (NASDAQ:
ATOS) today announced second quarter 2015 financial results and provided an update on recent company developments.
Dr. Steven C. Quay, Chairman, CEO & President, commented, "We
are highly encouraged by our second quarter performance with record revenues for our Pharmacogenomics tests and our acquisition
of the rights to Besins Healthcare's Afimoxifene Gel, which we are developing for the potential treatment of hyperplasia
of the breast. We've made great advancements towards achieving our goals for 2015 and we look forward to continued progress
towards initiating clinical trials using our microcathers for the local administration of a pharmaceutical and growing our revenues
with our products and services."
Recent Corporate Developments
Important recent corporate developments include the following:
Second Quarter 2015 Financial Results
For the three months and six months ended June 30, 2015, we had
total net revenue of $2,694,157 and $4,567,425, respectively, from our pharmacogenomics testing, compared to $9,875 and $33,999
of revenue in the same periods in 2014, which consisted of additional cash collections on NAF cytology tests performed in 2013.
In March 2015, we began the launch of the FullCYTE Breast Aspirator in the U.S. and the ForeCYTE Breast Aspirator in the EU, focusing
initially on the Netherlands, Germany, Switzerland and the United Kingdom. These devices are in the early stages of commercialization
and have not yet generated revenue.
For the three months and six months ended June 30, 2015, gross profit
totaled $839,446 and $1,504,760, compared to $9,875 and $33,999 in the same period in 2014. Total cost of revenue for the three
months and six months ended June 30, 2015 was $1,854,711 and $3,062,665, 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 June 30, 2015, total operating expenses
were $4,033,391 consisting of general and administrative (G&A) expenses of $2,790,872, research and development (R&D) expenses
of $510,458, and selling expenses of $732,061, representing an increase of $836,983, or 26% from $3,196,408 in the same period
in 2014, consisting of G&A expenses of $2,462,256, R&D expenses of $510,767, and selling expenses of $223,385. Operating
expenses for the six months ended June 30, 2015 were $7,982,581 consisting of G&A expenses of $5,395,983, R&D expenses
of $1,307,683, and selling expenses of $1,278,915. Operating expenses increased $2,351,124, or 42% from $5,631,457 for the same
period in 2014 consisting of $4,236,964 in G&A expenses, $933,270 in R&D expenses, and $461,223 in selling expenses.
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 and commercialization 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
and outside the United States to support the launch and commercialization of the FullCYTE and ForeCYTE Breast Aspirators and our
laboratory service offerings. Selling expenses may also increase as we market and sell the services offered by the NRLBH, including
NAF cytology tests, 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 increases in compensation expenses, professional fees, and recruiting fees as we hired additional headcounts to support
the launch of our new products; as well as an increase in bad debt expenses as a result of significant increases in revenue.
We expect our G&A and selling expenses to continue to grow throughout
2015 as we hire additional administrative and manufacturing personnel to support increased sales and operating activities as we
commercialize the ForeCYTE Breast Aspirator and FullCYTE Breast Aspirator, pharmacogenomics testing and our other products and
services under development and as we incur additional costs associated with being a publicly traded company.
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 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 Afimoxifene Gel and other potential pharmaceuticals
and conducting one or more clinical studies.
Conference Call Information
Management will host a conference call on Thursday, August 6, 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 September 7, 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 number is 10070543.
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health through
the development of laboratory services, medical devices and therapeutics. The laboratory services are being developed by its subsidiary,
The National Reference Laboratory for Breast Health Inc. The laboratory 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
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, Atossa's ability to achieve its objectives, continue to manufacture and
sell its products, recalls of products, 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
| June 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 11,402,935 | $ | 8,500,718 | ||||
| Accounts receivable, net | 2,012,153 | 297,958 | ||||||
| Prepaid expenses | 239,092 | 247,207 | ||||||
| Inventory, net | 101,339 | 39,788 | ||||||
| Total current assets | 13,755,519 | 9,085,671 | ||||||
| Furniture and equipment, net | 360,206 | 357,532 | ||||||
| Intangible assets, net | 1,822,328 | 1,920,645 | ||||||
| Deferred financing costs | 570,500 | 351,961 | ||||||
| Other assets | 52,647 | 48,193 | ||||||
| Total assets | $ | 16,561,200 | $ | 11,764,002 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 580,541 | $ | 594,357 | ||||
| Accrued expenses | 1,900,284 | 444,861 | ||||||
| Payroll liabilities | 840,228 | 1,056,705 | ||||||
| Short-term lease obligations | 72,338 | 76,025 | ||||||
| Other current liabilities | 20,272 | 42,228 | ||||||
| Total current liabilities | 3,413,663 | 2,214,176 | ||||||
| Deferred rent, net of current portion | 10,019 | 2,483 | ||||||
| Long-term lease obligations | 12,531 | 49,216 | ||||||
| Total liabilities | 3,436,213 | 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, 29,046,260 and 24,564,058 shares issued and outstanding | 29,046 | 24,564 | ||||||
| Additional paid-in capital | 54,751,098 | 44,648,103 | ||||||
| Accumulated deficit | (41,655,157 | ) | (35,174,540 | ) | ||||
| Total stockholders' equity | 13,124,987 | 9,498,127 | ||||||
| Total liabilities and stockholders' equity | $ | 16,561,200 | $ | 11,764,002 |
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| For the Three Months Ended June 30, | For The Six Months Ended June 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Net revenue | $ | 2,694,157 | $ | 9,875 | $ | 4,567,425 | $ | 33,999 | ||||||||
| Cost of revenue | 1,854,711 | - | 3,062,665 | - | ||||||||||||
| Gross profit | 839,446 | 9,875 | 1,504,760 | 33,999 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Selling | 732,061 | 223,385 | 1,278,915 | 461,223 | ||||||||||||
| Research and development | 510,458 | 510,767 | 1,307,683 | 933,270 | ||||||||||||
| General and administrative | 2,790,872 | 2,462,256 | 5,395,983 | 4,236,964 | ||||||||||||
| Total operating expenses | 4,033,391 | 3,196,408 | 7,982,581 | 5,631,457 | ||||||||||||
| Operating loss | (3,193,945 | ) | (3,186,533 | ) | (6,477,821 | ) | (5,597,458 | ) | ||||||||
| Other income (expense) | 48,619 | (1,443 | ) | (2,796 | ) | (2,049 | ) | |||||||||
| Loss before income taxes | (3,145,326 | ) | (3,187,976 | ) | (6,480,617 | ) | (5,599,507 | ) | ||||||||
| Income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (3,145,326 | ) | $ | (3,187,976 | ) | $ | (6,480,617 | ) | $ | (5,599,507 | ) | ||||
| Loss per common share - basic and diluted | $ | (0.11 | ) | $ | (0.13 | ) | $ | (0.25 | ) | $ | (0.24 | ) | ||||
| Weighted average shares outstanding, basic & diluted | 27,686,202 | 24,430,346 | 25,805,293 | 23,515,576 |