0001193805-18-000343.txt : 20180305 0001193805-18-000343.hdr.sgml : 20180305 20180305070101 ACCESSION NUMBER: 0001193805-18-000343 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20180305 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20180305 DATE AS OF CHANGE: 20180305 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ADMA BIOLOGICS, INC. CENTRAL INDEX KEY: 0001368514 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 562590442 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36728 FILM NUMBER: 18664391 BUSINESS ADDRESS: STREET 1: C/O ADMA BIOLOGICS, INC. STREET 2: 465 STATE ROUTE 17 CITY: RAMSEY STATE: NJ ZIP: 07446 BUSINESS PHONE: (201) 478-5552 MAIL ADDRESS: STREET 1: C/O ADMA BIOLOGICS, INC. STREET 2: 465 STATE ROUTE 17 CITY: RAMSEY STATE: NJ ZIP: 07446 FORMER COMPANY: FORMER CONFORMED NAME: R&R ACQUISITION VI, INC DATE OF NAME CHANGE: 20060707 8-K 1 e617752_8k-adma.htm

 

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): March 5, 2018

 

ADMA BIOLOGICS, INC.
(Exact name of registrant as specified in its charter)
     
Delaware 001-36728 56-2590442

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

   
465 State Route 17, Ramsey, New Jersey 07446
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (201) 478-5552

 

 
(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 (see General Instruction A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ý

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

Item 2.02.Results of Operations and Financial Condition.

 

On March 5, 2018, ADMA Biologics, Inc. issued a press release announcing its financial results for the year ended December 31, 2017. A copy of the press release is furnished herewith as Exhibit 99.1.*

 

Item 9.01.Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No. Description
99.1 ADMA Biologics, Inc. Press Release, dated March 5, 2018.

 

* The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

  

 

 

 

SIGNATURE

 

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.

 

March 5, 2018 

ADMA Biologics, Inc.
   
   
  By: /s/ Brian Lenz
    Name: Brian Lenz
    Title: Vice President and Chief Financial Officer

 

 

 

 

EX-99.1 2 e617752_ex99-1.htm

 

 

 

ADMA Biologics Reports Full Year 2017 Financial Results

 

RAMSEY, N.J. and BOCA RATON, FL., – March 5, 2018 – ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immmune deficiencies and prevention of certain infectious diseases, today announced its financial results for the year ended December 31, 2017.

 

Financial Results for the Year Ended December 31, 2017

 

ADMA reported total revenues of $22.8 million for the year ended December 31, 2017, as compared to $10.7 million for the year ended December 31, 2016, representing an increase of $12.1 million, or approximately 113%. The increase in revenues was primarily due to the accretive nature of assets and commercial product rights acquired from the Biotest Pharmaceuticals Corporation Therapy Business Unit (“BTBU”), which was completed in June 2017.

 

The consolidated net loss for the year ended December 31, 2017 was $43.8 million, or $1.91 per basic and diluted share, as compared to a consolidated net loss of $19.5 million, or $1.61 per basic and diluted share, for the year ended December 31, 2016. The increase in net loss of $24.3 million was attributable to increased product revenue costs of $22.8 million, which included manufacturing costs related to our plasma fractionation production facility in Boca Raton, FL acquired in the BTBU transaction (the “Boca Facility”), third-party consultant fees of approximately $3.8 million pertaining to the remediation efforts and enhancements of the Company’s quality management systems in preparation for an FDA inspection, as well as increased selling, general and administrative expenses (“SG&A”) of $9.6 million. SG&A in 2017 included transaction costs of $3.9 million for the acquisition of BTBU as well as expenses associated with BTBU not present in 2016. The increased operational costs in 2017 were offset by the increased revenues. Included in the net loss for the year ended December 31, 2017 were non-cash expenses of $6.9 million for stock-based compensation, depreciation and amortization, non-cash interest expense, an asset impairment charge and a loss on the extinguishment of debt related to the refinancing of the Company’s senior debt in October 2017.

 

Adam Grossman, President and Chief Executive Officer of ADMA, stated, “We are pleased with our significant year-over-year revenue growth in 2017, which includes accretive revenues related to Nabi-HB in addition to the organic revenue growth of approximately 11% related to our plasma collection centers business segment. In addition, we believe that the substantial progress we have made with our Compliance Enhancement Program has allowed us to remedy the identified compliance issues at the Boca Facility, and we believe that we are now ready for a routine inspection of the facility by the U.S. Food and Drug Administration as we continue to execute on our business plan.”

 

1

 

At December 31, 2017, ADMA had cash, cash equivalents and short-term investments of $43.1 million, as compared to $15.3 million at December 31, 2016. ADMA’s net working capital as of December 31, 2017 was $53.7 million, as compared to $10.4 million as of December 31, 2016.

 

About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is a vertically integrated commercial biopharmaceutical and specialty immunoglobulin manufacturing company that currently manufactures, markets and develops specialty plasma-based biologics for the treatment of immune deficiencies and prevention of certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283 and 9,815,886 related to certain aspects of its lead product candidate, RI-002. For more information, please visit www.admabiologics.com.

 

Forward-Looking Statements

This press release contains "forward-looking statements" pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. ("we“, “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "estimate," “project,” "intend," “forecast,” "target,” ”anticipate,” “plan,” “planning,” “expect,” “believe,” “will," “is likely,” “will likely,” “should,” “could,” "would," "may," or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements concerning our plans to develop, manufacture, market, launch and expand our own commercial infrastructure and commercialize our current products and future products, the safety, efficacy and expected timing of, and our ability to, obtain and maintain regulatory approvals of our current products and product candidates, and the labeling or nature of any such approvals, the success of our work with our third party vendors and the U.S. Food and Drug Administration (the “FDA”) in furtherance of and progress towards an approval of our Biologics License Application for specialty plasma-based biologics and the ability of such third parties to respond adequately or in a timely manner to the issues raised by the FDA, our ability to successfully pursue commercialization and prelaunch activities, the timeframe within which we may receive approval from the FDA for specialty plasma-based biologics, if at all, the potential of our specialty plasma-based biologics to provide meaningful clinical improvement for patients living with Primary Immune Deficiency Disease or other indications, our ability to realize increased prices for plasma growth in the plasma collection industry and our expectations for future capital requirements. Actual events or results may differ materially from those described in this document due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by ADMA or any other person that the objectives and plans of ADMA will be achieved in any specified time frame, if at all. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

 

CONTACT: Brian Lenz

Vice President and Chief Financial Officer |201-478-5552 | www.admabiologics.com

 

INVESTOR RELATIONS CONTACT: Jeremy Feffer

Managing Director, LifeSci Advisors, LLC |212-915-2568 |

 

2

 

ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
Years Ended December 31, 2017 and 2016

 

   2017  2016
REVENUES:          
  Product revenue  $15,617,726   $10,518,203 
  License revenue   142,834    142,834 
  Other revenue   7,000,000    —   
      Total Revenues   22,760,560    10,661,037 
           
OPERATING EXPENSES:          
   Cost of product revenue (exclusive of amortization expense shown below)   29,164,321    6,360,761 
   Research and development   6,229,587    7,688,238 
   Plasma centers   6,503,750    5,447,691 
   Asset impairment charge   845,389    —   
   Amortization of intangibles   1,234,674    —   
   Selling, general and administrative   18,092,835    8,494,742 
           
TOTAL OPERATING EXPENSES   62,070,556    27,991,432 
           
LOSS FROM OPERATIONS   (39,309,996)   (17,330,395)
           
OTHER INCOME (EXPENSE):          
   Interest and other income   57,228    50,317 
   Interest expense   (3,285,847)   (2,239,569)
   Loss on extinguishment of debt   (1,210,216)   —   
   Other (expense) income   (10,144)   4,496 
OTHER EXPENSE, NET   (4,448,979)   (2,184,756)
           
NET LOSS  $(43,758,975)  $(19,515,151)
           
BASIC AND DILUTED LOSS PER COMMON SHARE  $(1.91)  $(1.61)
           
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:          
   Basic and Diluted   22,896,042    12,153,407 

 

 

ADMA BIOLOGICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED Balance Sheets:

   December 31,  December 31,
   2017  2016
ASSETS          
 Current assets:          
   Cash and cash equivalents  $43,107,574   $9,914,867 
   Short-term investments   —      5,390,184 
   Accounts receivable, net   3,880,154    1,018,027 
   Inventories   12,628,181    5,020,146 
   Prepaid expenses and other current assets   2,050,740    313,914 
   Restricted cash   1,500,000    —   
      Total current assets   63,166,649    21,657,138 
 Property and equipment, net   30,466,858    2,000,784 
 Intangible assets, net   4,849,350    —   
 Goodwill   3,529,509    —   
 Assets to be transferred under purchase agreement   1,496,410    —   
 Restricted cash   4,000,000    —   
 Deposits and other assets   510,057    27,163 
 TOTAL ASSETS  $108,018,833   $23,685,085 
           
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)          
 Current liabilities:          
   Accounts payable  $5,920,873   $2,564,681 
   Accrued expenses   3,318,478    2,385,356 
   Current portion of notes payable   —      6,111,111 
   Current portion of deferred revenue   142,834    145,154 
   Other current liabilities   57,998    16,559 
      Total current liabilities   9,440,183    11,222,861 
 Notes payable, net of discount   25,368,458    12,321,640 
 End of term liability, notes payable   2,760,000    1,790,000 
 Deferred revenue, net of current portion   2,547,199    2,690,033 
 Note payable - related party, net of discount   14,842,396    —   
 Obligation to transfer assets under purchase agreement   12,621,844    —   
 Other non-current liabilities   105,996    117,813 
 TOTAL LIABILITIES   67,686,076    28,142,347 
           
COMMITMENTS AND CONTINGENCIES   —      —   
           
STOCKHOLDERS' EQUITY (DEFICIT)          
           
   Preferred Stock, $0.0001 par value, 10,000,000 shares authorized,          
      no shares issued and outstanding   —      —   
   Common Stock - voting, $0.0001 par value, 75,000,000 shares          
      authorized, 36,725,499 and 12,886,741 shares issued and outstanding   3,673    1,289 
   Common Stock - non-voting, $0.0001 par value, 8,591,160 shares          
      authorized, 8,591,160 and 0 shares issued and outstanding   859    —   
   Additional Paid-In Capital   191,022,018    102,476,267 
   Accumulated Deficit   (150,693,793)   (106,934,818)
TOTAL STOCKHOLDERS' EQUITY (DEFICIT)   40,332,757    (4,457,262)
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)  $108,018,833   $23,685,085 

 

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