UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): May 13, 2015
Atossa Genetics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-35610 | 26-4753208 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (I.R.S. Employer Identification No.) |
|
2345 Eastlake Ave. East, Suite 201 Seattle, Washington |
98102 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (206) 325-6086
Not Applicable
Former name or former address, if changed since last report
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. Results of Operations and Financial Condition.
On May 13, 2015, Atossa Genetics Inc. (the “Company”) issued a press release announcing first quarter 2015 financial results and a company update. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
The information in the report, including Exhibit 99.1 attached
hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended,
or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended.
The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the
U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general
incorporation language in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated May 13, 2015 |
* * *
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 13, 2015 | Atossa Genetics Inc. | |
| By: | /s/ Kyle Guse | |
| Kyle Guse | ||
| Chief Financial Officer, General Counsel and Secretary | ||
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release, dated May 13, 2015 |
Exhibit 99.1
Atossa Genetics Announces First Quarter 2015 Financial Results
and Provides Company Update
Achieves Total Revenue for Q1 2015 of $1.9 Million
Conference Call to be Held Today at 4:30 pm Eastern Time
SEATTLE, May 13, 2015 -- Atossa Genetics Inc. (NASDAQ: ATOS) today announced first quarter 2015 financial results and provided an update on recent company developments.
Steve Quay, President and CEO, commented, “We have made tremendous progress towards achieving our 2015 objectives by launching the ForeCYTE Breast Aspirator in the European Union and the FullCYTE breast aspirator in the United States. We engaged key national distributors in the United States and are seeing very strong growth with our pharmacogenomics tests. We look forward to continued progress towards our other key 2015 objectives which are to begin clinical studies in a therapeutic using our devices and growing our revenue with our products and services.”
Recent Corporate Developments
Important recent corporate developments include the following:
| · | Launched the ForeCYTE Breast Aspirator in the European Union |
| · | Launched the FullCYTE Breast Aspirator in the United States |
| · | Engaged two leading national distributors in the United States |
| · | Hired Biopharmaceutical industry veteran Cindy Atha as Vice President of Sales and Marketing |
| · | Secured In-Network Contract With Meridian Health Plan of Michigan |
| · | The College of American Pathologists certified our laboratory, The National Reference Laboratory for Breast Health Inc. |
First Quarter 2015 Financial Results
Revenue for the three months March 31, 2015 totaled $1,873,268, consisting of mainly pharmacogenomics testing, compared to $24,124 revenue in the same period in 2014 from additional cash collections on NAF cytology tests. Total cost of revenue for the three months ended March 31, 2015 was $1,207,954 and consisted of costs relating to pharmacogenomics testing services, compared to $0 for the same period in 2014.
Gross profit for the three months ended March 31, 2015 was $665,314, attributable to pharmacogenomics testing, compared to $24,124 gross profit in the same period in 2014.
Total operating expenses were $3,949,190 for the three months ended March 31, 2015, consisting of general and administrative (G&A) expenses of $2,605,111, R&D expenses of $797,225, and selling expenses of $546,854 representing an increase of $1,514,141, or 62%, from $2,435,049 for the three months ended March 31, 2014, which consisted of G&A expenses of $1,774,708, R&D expenses of $422,503, and selling expenses of $237,838.
Conference Call Information
Management will host a conference call today, Wednesday, May 13, 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 June 14, 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 10065375.
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 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, 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.
Contact:
Atossa Genetics, Inc.
Kyle Guse
CFO and General Counsel
(O) 800-351-3902
Kyle.Guse@atossagenetics.com
Investor Relations:
CorProminence LLC
Scott Gordon
President
516-222-2560
scottg@corprominence.com
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2015 | 2014 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 9,728,369 | $ | 8,500,718 | ||||
| Accounts receivable, net | 1,280,209 | 297,958 | ||||||
| Prepaid expense | 263,763 | 247,207 | ||||||
| Inventory, net | 94,628 | 39,788 | ||||||
| Total current assets | 11,366,969 | 9,085,671 | ||||||
| Furniture and equipment, net | 381,590 | 357,532 | ||||||
| Intangible assets, net | 1,877,755 | 1,920,645 | ||||||
| Deferred financing costs | - | 351,961 | ||||||
| Other assets | 176,551 | 48,193 | ||||||
| Total assets | $ | 13,802,865 | $ | 11,764,002 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 966,208 | $ | 594,357 | ||||
| Accrued expenses | 1,117,932 | 444,861 | ||||||
| Payroll liabilities | 1,279,528 | 1,056,705 | ||||||
| Short-term lease obligations | 79,974 | 76,025 | ||||||
| Other current liabilities | 42,914 | 42,228 | ||||||
| Total current liabilities | 3,486,556 | 2,214,176 | ||||||
| Deferred rent, net of current portion | 7,227 | 2,483 | ||||||
| Long-term lease obligations | 25,230 | 49,216 | ||||||
| Total liabilities | 3,519,013 | 2,265,875 | ||||||
| Commitments and contingencies | ||||||||
| 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, 27,217,257 and 24,564,058 shares issued and outstanding | 27,217 | 24,564 | ||||||
| Additional paid-in capital | 48,766,466 | 44,648,103 | ||||||
| Accumulated deficit | (38,509,831 | ) | (35,174,540 | ) | ||||
| Total stockholders' equity | 10,283,852 | 9,498,127 | ||||||
| Total liabilities and stockholders' equity | $ | 13,802,865 | $ | 11,764,002 | ||||
ATOSSA GENETICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| For the Three Months Ended March 31 , | ||||||||
| 2015 | 2014 | |||||||
| Revenue | ||||||||
| Diagnostic testing services | $ | 1,872,798 | $ | 24,124 | ||||
| Product sales | 470 | - | ||||||
| Total revenue | 1,873,268 | 24,124 | ||||||
| Cost of revenue | ||||||||
| Diagnostic testing services | 1,206,312 | - | ||||||
| Product sales | 1,642 | - | ||||||
| Total cost of revenue | 1,207,954 | - | ||||||
| Gross profit | 665,314 | 24,124 | ||||||
| Selling expenses | 546,854 | 237,838 | ||||||
| Research and development expenses | 797,225 | 422,503 | ||||||
| General and administrative expenses | 2,605,111 | 1,774,708 | ||||||
| Total operating expenses | 3,949,190 | 2,435,049 | ||||||
| Operating loss | (3,283,876 | ) | (2,410,925 | ) | ||||
| Interest income | 279 | 143 | ||||||
| Interest expense | 1,784 | 749 | ||||||
| Other losses | 49,910 | - | ||||||
| Loss before income taxes | (3,335,291 | ) | (2,411,531 | ) | ||||
| Income taxes | - | - | ||||||
| Net loss | $ | (3,335,291 | ) | $ | (2,411,531 | ) | ||
| Loss per common share - basic and diluted | $ | (0.13 | ) | $ | (0.10 | ) | ||
| Weighted average shares outstanding, basic and diluted | 24,916,867 | 24,419,060 | ||||||