SOURCE: Atossa Genetics, Inc.

Atossa Genetics, Inc.

May 15, 2013 08:30 ET

Atossa Genetics Reports First Quarter 2013 Results and Operating Highlights

SEATTLE, WA--(Marketwired - May 15, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), the Breast Health Company™, today announced its first quarter 2013 financial results and corporate developments. 

"The national rollout of our ForeCYTE Breast Health Test is proceeding well and we are pleased with the response we are getting from the physician community and from patients," stated Dr. Steven Quay, chairman, CEO and president. "We were particularly pleased to have completed an agreement with Millennium HealthCare, Inc., which provides primary care physician practices, physician groups and healthcare facilities of all sizes with cutting edge medical devices focused primarily on preventive care through early detection. Millennium has initially submitted an order for 10,000 ForeCYTE Breast Health collection kits for distribution to its network of physicians' offices in the New York Metro area and Northern New Jersey. We anticipate signing up additional distributors this year and continuing to build our internal sales and marketing team."

Corporate Highlights

  • Continued the national rollout of the ForeCYTE Breast Health Test, which the Company launched in January 2013.
  • Completed a $30 million At-The-Market Common Stock Purchase Agreement with Aspire Capital Fund, LLC. Upon signing the agreement, Aspire purchased $1.0 million of Atossa's stock at $12.00 per share. Aspire has committed to purchase up to $29 million of Atossa's common stock over the next three years at prices based on prevailing market prices over a period preceding each sale.
  • Signed a distribution agreement with Millennium HealthCare, Inc. Millennium placed an initial purchase order for 10,000 ForeCYTE collection kits, which it intends to distribute to its physician practices in the New York Metro Area and Northern New Jersey.
  • Two leading breast centers in Texas, Aurora Breast Center in San Antonio and The Breast Center at Wellness Lubbock in Lubbock, will begin offering the ForeCYTE test to their patients. Three breast centers in Texas are now offering the ForeCYTE test.
  • Launched a Nationwide Awareness Program including a new video to educate women and health care providers on the prevention of breast cancer by early testing for pre-cancerous breast conditions using the ForeCYTE Breast Health Test.
  • Continued development of the FullCYTE test, which is designed to identify the particular duct that is undergoing pre-cancerous or cancerous changes, and the NextCYTE test, which uses genomic analysis to provide important insights to inform and improve the effectiveness of breast cancer treatment for women with early-stage breast cancer. Atossa intends to launch both of these tests in 2013.
  • Atossa exhibited the ForeCYTE test at the 61st Annual Clinical Meeting of the American Congress of Obstetrics and Gynecology in New Orleans, the largest gathering of OB/GYNs in the U.S.

First Quarter 2013 Financial Results

Revenues for the three months ended March 31, 2013, were $182,670, which included $13,440 of product revenue from the sale of MASCT Systems and $169,230 of diagnostic testing service revenue from the ForeCYTE breast health tests. This compares with total revenues of $54,713 for the first quarter ended March 31, 2012. The year-over-year increase in total revenue was driven by the national rollout of the ForeCYTE test in January 2013.

Gross profit for the three months ended March 31, 2013, was $116,206. This compares to gross profit of $27,709 for the quarter ended March 31, 2012.

Net loss for the quarter ended March 31, 2013, was $1.9 million, or $(0.14) per share, compared with net loss of $1.1 million, or $(0.09) per share, for the first quarter ended March 31, 2012. The increase in net loss was primarily attributable to an increase in general and administrative expense of $963,420, including increased expenses related to the national launch of the ForeCYTE test.

Total operating expenses were $2.1 million for the three months ended March 31, 2013, consisting of G&A expenses of $1.6 million, selling expenses of $272,575 and research and development expenses of $220,192. This compares to total operating expenses of $1.1 million for the three months ended March 31, 2012, consisting of G&A expenses of $601,452, selling expenses of $70,435 and research and development expenses of $417,990. The increase in G&A expenses of $963,420, from the first quarter of 2012 to the first quarter of 2013, is attributed to the launch of the Company's MASCT System, ForeCYTE test and ArgusCYTE test and the related growth in expenses to hire additional staff and expand the Company's operations. Atossa expects that its G&A expenses will continue to increase as it adds additional employees and incurs additional costs as a publicly traded company. Additionally, G&A costs are expected to rise as the Company increases headcount to coordinate the production and manufacture of the MASCT System, and the expected increase in service revenue. Selling expenses increased $202,140 from the first quarter of 2012 to the first quarter of 2013 as a result of hiring additional sales and marketing personnel and incurring additional marketing expenses directly and to the Company's distributor for the national launch of the ForeCYTE test. Research and development expenses decreased by $197,798 from the first quarter of 2012 to the first quarter of 2013 as a result of completion of the development of the ForeCYTE test and ArgusCYTE test in 2012 and as a result of Atossa's focus in 2013 on the national launch of ForeCYTE.

At March 31, 2013, Atossa had cash and cash equivalents of $1.4 million.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, is based in Seattle, WA, and is focused on preventing breast cancer through the commercialization of patented, FDA-designated Class II diagnostic medical devices and patented, laboratory developed tests (LDT) that can detect precursors to breast cancer up to eight years before mammography, and through research and development that will permit it to commercialize treatments for pre-cancerous lesions.

The National Reference Laboratory for Breast Health (NRLBH), a wholly owned subsidiary of Atossa Genetics, Inc., is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, WA, that provides the patented ForeCYTE Breast Health Test, a risk assessment test for women 18 to 73 years of age akin to the Pap Smear, and the ArgusCYTE Breast Health Test, a blood test for recurrence in breast cancer survivors that provides a "liquid biopsy" for circulating cancer cells and a tailored treatment plan for patients and their caregivers.

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, regulatory clearances, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, the efficacy of Atossa's products and services, the market demand for and acceptance of Atossa's products and services, performance of distributors and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its registration statement on Form S-1 filed April 5, 2013, and periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

   
ATOSSA GENETICS INC.  
(A DEVELOPMENT STAGE COMPANY)  
CONSOLIDATED BALANCE SHEETS  
   
  March 31,   December 31,  
  2013   2012  
  (Unaudited)   (Audited)  
Assets            
Current Assets            
  Cash and cash equivalents $ 1,385,199   $ 1,725,197  
  Accounts receivable   259,339     141,665  
  Prepaid expense   2,521,098     122,633  
    Total Current Assets   4,165,636     1,989,495  
             
Fixed Assets            
  Furniture and Equipment, net   150,421     159,967  
    Total Fixed Assets   150,421     159,967  
             
Other Assets            
  Security deposit   36,446     36,446  
  Intangible assets, net   4,559,326     4,640,224  
    Total Other Assets   4,595,772     4,676,670  
               
    Total Assets $ 8,911,829   $ 6,826,133  
             
Liabilities and Stockholders' Equity            
             
Current Liabilities            
  Accounts payable   34,591     68,217  
  Accrued expenses   1,901,674     1,582,381  
    Total Current Liabilities   1,936,265     1,650,598  
             
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, 14,508,019 and 11,256,867 shares issued and outstanding   14,508     12,919  
  Additional paid-in capital   18,634,404     14,894,522  
  Accumulated deficit   (11,673,348 )   (9,731,906 )
    Total Stockholders' Equity   6,975,564     5,175,535  
               
    Total Liabilities and Stockholders' Equity $ 8,911,829   $ 6,826,133  
             
             
             
ATOSSA GENETICS, INC.  
(A DEVELOPMENT STAGE COMPANY)  
CONSOLIDATED STATEMENTS OF OPERATIONS  
(UNAUDITED)  
   
    For the Three Months Ended March 31,     From April 30, 2009
(Inception) Through
 
    2013     2012     March 31, 2013  
                         
Revenue                        
  Diagnostic Testing Service   $ 169,230     $ 52,713     $ 644,632  
  Product Sales     13,440       2,000       21,380  
    Total Revenue     182,670       54,713       666,012  
                         
Cost of Revenue                        
  Diagnostic Testing Service     (47,599 )     (3,197 )     (83,344 )
  Product Sales     (18,865 )     -       (24,029 )
    Total Cost of Revenue     (66,464 )     (3,197 )     (107,373 )
                         
Loss on Reduction of Inventory to LCM     -       (23,807 )     (121,910 )
                         
    Gross Profit (Loss)     116,206       27,709       436,729  
                         
Selling expenses     (272,575 )     (70,435 )     (912,451 )
Research and Development expenses     (220,192 )     (417,990 )     (3,777,578 )
General and Administrative expenses     (1,564,872 )     (601,452 )     (7,387,209 )
    Total operating expenses     (2,057,639 )     (1,089,877 )     (12,077,238 )
                         
Operating Loss     (1,941,433 )     (1,062,168 )     (11,640,507 )
                         
Interest Income     -       863       6,588  
Interest Expense     (7 )     (1,613 )     (39,178 )
                         
Net Loss before Income Taxes     (1,941,440 )     (1,062,918 )     (11,673,097 )
                         
Income Taxes     -       -       250  
                         
Net Loss   $ (1,941,440 )   $ (1,062,918 )   $ (11,673,347 )
                         
Loss per common share - basic and diluted   $ (0.14 )   $ (0.09 )   $ (1.36 )
Weighted average shares outstanding, basic & diluted     13,421,119       11,256,867       8,594,390  
                         

Contact Information

  • Contact:

    Atossa Genetics, Inc.
    Kyle Guse
    Chief Financial Officer and General Counsel
    800-351-3902
    Email Contact

    Matthew D. Haines (Investors)
    Managing Director
    MBS Value Partners
    212-710-9686
    Email Contact