-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MJLEPh8l0sriNzkwQAJAxicn473U/QqtBY6W3x4/7fATv1I8ctojFBPV8lHlFx/F LFK55XUIUqX4lWZVwTKznA== 0000950137-07-011303.txt : 20070803 0000950137-07-011303.hdr.sgml : 20070803 20070803173014 ACCESSION NUMBER: 0000950137-07-011303 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070730 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070803 DATE AS OF CHANGE: 20070803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AKORN INC CENTRAL INDEX KEY: 0000003116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 720717400 STATE OF INCORPORATION: LA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32360 FILM NUMBER: 071025019 BUSINESS ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 8-K 1 c17447e8vk.htm CURRENT REPORT e8vk
 

 
 
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
Date of Report: July 30, 2007
(Date of Earliest Event Reported)
Akorn, Inc.
(Exact Name of Registrant as Specified in its Charter)
         
Louisiana
(State or other
Jurisdiction of
Incorporation)
  0-13976
(Commission
File Number)
  72-0717400
(I.R.S. Employer
Identification No.)
2500 MILLBROOK DRIVE
BUFFALO GROVE, ILLINOIS

(Address of principal executive offices)
(847) 279-6100
(Registrant’s telephone number, including area code)
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)
 
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 July 30, 2007, Akorn, Inc. (“Akorn”) issued a press release announcing certain results of Akorn’s financial review for the quarter ended June 30, 2007. A copy of the press release is attached hereto as Exhibit 99.1.
     The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01     FINANCIAL STATEMENTS AND EXHIBITS.
          (d)     Exhibits.
          99.1     Press release dated July 30, 2007.

 


 

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
      
         
  Akorn, Inc.
 
 
  By:   /s/ Jeffrey A. Whitnell    
    Jeffrey A. Whitnell   
    Chief Financial Officer, Treasurer and Secretary   
 
Date: August 3, 2007

 

EX-99.1 2 c17447exv99w1.htm PRESS RELEASE exv99w1
 

Exhibit 99.1
At the Company:
Akorn, Inc.
Arthur S. Przybyl, President and CEO
Jeffrey A. Whitnell, CFO
(847) 279-6100
FOR IMMEDIATE RELEASE
Akorn Reports Second Quarter 2007 Financial Results
Buffalo Grove, IL, July 30, 2007 — Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the second quarter ended June 30, 2007.
Total revenue for the second quarter 2007 was $11.6 million as compared to $12.5 million in the second quarter 2006. Gross profit for the second quarter 2007 was $2.9 million as compared to $5.0 million in the second quarter 2006. The decline in second quarter 2007 revenue and gross profit versus the comparative prior year period is primarily due to customer backorders for IC-Green, which totaled $2.5 million as of June 30, 2007.
The net loss available to common stockholders for the second quarter 2007 was $4.6 million or $0.05 per fully diluted share vs. a net loss available to common stockholders of $2.2 million in the second quarter 2006 or $0.03 per fully diluted share. As of June 30, 2007, the Company had cash and cash equivalents equal to $12.9 million.
Highlights for the Second Quarter 2007:
    New Product Development:
    April 5, 2007: Akorn announced the appointment of Shawn L. Silvestri, Ph.D. as Vice President, New Product Development. Dr. Silvestri is responsible for transitioning our product development efforts from our manufacturing site locations to a centralized Center for Excellence near our corporate headquarters. The Company’s objective is to file at least 12 internally developed ANDA’s per year.
    Biologics and Vaccines Business Segment:
    May 22, 2007: Akorn announced the appointment of Douglas R. Pinnell as Vice President, Vaccine Sales. Mr. Pinnell is responsible for the September 2007 product launch of our Tetanus Diphtheria Vaccine.

 


 

    Hospital Drugs and Injectables Business Segment:
    June 8, 2007: Akorn announced the expansion of its business partnership with Natco Pharma Limited by adding two injectable ANDA anti-cancer drug products to their API Supply and Margin Sharing Agreement.
 
    June 21, 2007: Akorn announced the signing of an exclusive drug development and supply agreement with Cipla, Ltd. for an oral ANDA drug product for the prevention of organ transplant rejection.
 
    July 17, 2007: Akorn announced the signing of an exclusive development and supply agreement with Haemonetics Corporation for three premix drug products. Premix medications are ready to use intravenous drug products which eliminate drug compounding steps in the pharmacy or point of care.
 
    July 17, 2007: Akorn-Strides, LLC announced its first ANDA approval for Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL.
 
    July 19, 2007: Akorn announced the signing of an exclusive drug development and supply agreement with Cipla, Ltd. for an injectable ANDA drug product for the prevention of organ transplant rejection.
    Ophthalmic Business Segment:
    June 29, 2007: Akorn announced the filing of NDA 22-221 for Akten® Ophthalmic Gel 3.5%, a topical anesthetic formulation. Akten® is a novel, unit dose, preservative free gel formulation intended to be used in any ocular procedure that requires a topical anesthetic agent.
Arthur S. Przybyl, President and Chief Executive Officer stated, “Over the last several quarters, we have built an infrastructure that will allow us to achieve our short term and long term objectives. We have a strong balance sheet and are a debt-free company. We have invested in product development efforts, both internally and externally with our fourteen business development partnerships, and are now poised to capitalize on these strategic investments.
Our opportunity for growth is represented by three near-term product launches:
· Akten®, our filed opththalmic NDA awaiting a PDUFA date
· Oral Vancomycin, on schedule for an ANDA approval in 2007
· Tetanus Diphtheria Vaccine to be launched September 2007
In the third quarter 2007, our expectation is to increase quarterly revenues by at least 50% as compared to the current quarter. This is based on the re-launch of IC-Green™, which requires us to successfully pass a pre-approval inspection at our Decatur manufacturing facility, the commercial launch of Tetanus Diphtheria Vaccine, and the launch of our Advanced Vision Research contract manufacturing agreement for TheraTears®.”

 


 

About Akorn, Inc.
Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn has manufacturing facilities located in Decatur, Illinois and Somerset, New Jersey and markets and distributes an extensive line of hospital and ophthalmic pharmaceuticals. Additional information is available at the Company’s website at www.akorn.com.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, these include statements relating to future steps we may take, prospective products, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. You are advised, however, to consult any further disclosures we make on related subjects in our reports filed with the SEC. In particular, you should read the discussion in the section entitled “Cautionary Statement Regarding Forward-Looking Statements” in our most recent Annual Report on Form 10-K, as it may be updated in subsequent reports filed with the SEC. That discussion covers certain risks, uncertainties and possibly inaccurate assumptions that could cause our actual results to differ materially from expected and historical results. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results.

 


 

AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
                 
    JUNE 30,     DECEMBER 31,  
    2007     2006  
    (UNAUDITED)     (AUDITED)  
ASSETS CURRENT ASSETS
               
Cash and cash equivalents
  $ 12,885     $ 21,818  
Trade accounts receivable (less allowance for doubtful accounts of $1 and $3, respectively)
    1,987       4,781  
Inventories
    15,897       11,734  
Prepaid expenses and other current assets
    881       1,321  
 
           
TOTAL CURRENT ASSETS
    31,650       39,654  
PROPERTY, PLANT AND EQUIPMENT, NET
    32,956       33,486  
OTHER LONG-TERM ASSETS
               
Intangibles, net
    8,198       8,825  
Other
    103       118  
 
           
TOTAL OTHER LONG-TERM ASSETS
    8,301       8,943  
 
           
TOTAL ASSETS
  $ 72,907     $ 82,083  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Current installments of debt
  $ 408     $ 394  
Trade accounts payable
    3,827       4,719  
Accrued compensation
    726       1,849  
Customer accrued liabilities
    253       391  
Accrued expenses and other liabilities
    963       2,900  
 
           
TOTAL CURRENT LIABILITIES
    6,177       10,253  
LONG-TERM LIABILITIES
               
Long-term debt, less current installments
          208  
Product warranty
    1,308       1,308  
 
           
TOTAL LONG-TERM LIABILITIES
    1,308       1,516  
 
           
TOTAL LIABILITIES
    7,485       11,769  
 
           
SHAREHOLDERS’ EQUITY
               
Common stock, no par value — 150,000,000 shares authorized; 87,579,283 and 85,990,964 shares issued and outstanding at June 30, 2007 and December 31, 2006, respectively
    156,877       150,250  
Warrants to acquire common stock
    2,820       4,862  
Accumulated deficit
    (94,275 )     (84,798 )
 
           
TOTAL SHAREHOLDERS’ EQUITY
    65,422       70,314  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 72,907     $ 82,083  
 
           

 


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
                                 
    THREE MONTHS ENDED     SIX MONTHS ENDED  
    JUNE 30,     JUNE 30,}  
    2007     2006     2007     2006  
Revenues
  $ 11,638     $ 12,475     $ 23,373     $ 42,205  
Cost of sales
    8 ,752       7,520       17,998       25,517  
 
                       
GROSS PROFIT
    2 ,886       4,955       5,375       16,688  
Selling, general and administrative expenses
    5 ,189       4,669       10,431       9,153  
Amortization and write-down of intangibles
    3 39       350       677       701  
Research and development expenses
    2,161       2,121       4,172       4,166  
 
                       
TOTAL OPERATING EXPENSES
    7 ,689       7,140       15,280       14,020  
 
                       
OPERATING (LOSS) / INCOME
    (4,803 )     (2,185 )     (9,905 )     2,668  
Interest income/(expense) — net
    1 69       234       428       (1,085 )
Debt Retirement Expense
                      (391 )
Other Income/(Expense)
    1       (12 )     1       (29 )
 
                       
(LOSS)/INCOME BEFORE INCOME TAXES
    (4,634 )     (1,963 )     (9,476 )     1,163  
Income tax provision
    1             1        
 
                       
NET (LOSS)/INCOME
    (4,634 )     (1,963 )     (9,477 )     1,163  
Preferred stock dividends and adjustments
          (234 )           (560 )
 
                       
NET (LOSS)/INCOME AVAILABLE TO COMMON STOCKHOLDERS
  $ (4,634 )   $ (2,197 )   $ (9,477 )   $ 603  
 
                       
NET (LOSS)/INCOME PER SHARE:
                               
BASIC
  $ (0.05 )   $ (0.03 )   $ (0.11 )   $ 0.01  
 
                       
DILUTED
  $ (0.05 )   $ (0.03 )   $ (0.11 )   $ 0.01  
 
                       
SHARES USED IN COMPUTING NET (LOSS)/INCOME PER SHARE:
                               
BASIC
    86,982       74,853       86,619       68,321  
 
                       
DILUTED
    86,982       74,853       86,619       76,481  
 
                       

 


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
                 
    SIX MONTHS  
    ENDED JUNE 30  
    2007     2006  
OPERATING ACTIVITIES
               
Net (loss) / income
  $ (9,477 )   $ 1,163  
Adjustments to reconcile net (loss)/income to net cash (used in)/provided by operating activities:
               
Depreciation and amortization
    2,188       1,645  
Amortization of debt discounts
          1,059  
Non-cash stock compensation expense
    1,877       978  
Changes in operating assets and liabilities:
               
Trade accounts receivable
    2,794       (1,765 )
Inventories
    (4,163 )     (691 )
Prepaid expenses and other current assets
    455       (363 )
Trade accounts payable
    (892 )     (314 )
Product warranty
          1,159  
Accrued customer liability
    (138 )     197  
Accrued expenses and other liabilities
    (3,060 )     (1,039 )
 
           
NET CASH (USED IN)/PROVIDED BY OPERATING ACTIVITIES
    (10,416 )     2,029  
INVESTING ACTIVITIES
               
Purchases of property, plant and equipment
    (981 )     (1,388 )
Purchase of intangible assets
    (50 )      
 
           
NET CASH USED IN INVESTING ACTIVITIES
    (1,031 )     (1,388 )
FINANCING ACTIVITIES (See Note 1 below)
               
Repayment of long-term debt
    (194 )     (2,917 )
Proceeds from common stock and warrant offering
          18,078  
Proceeds from warrants exercised
    2,492       888  
Proceeds under stock option and stock purchase plans
    216       300  
 
           
NET CASH PROVIDED BY FINANCING ACTIVITIES
    2,514       16,349  
(DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS
    (8,933 )     16,990  
Cash and cash equivalents at beginning of period
    21,818       791  
 
           
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 12,885     $ 17,781  
 
           
Amount paid for interest
  $ 25     $ 561  
Amount paid for income taxes
  $ 3     $ 2  

 

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