-----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, GFLArPQWNs5Nsr0KsaxwCK8D8f1w5pWpJq9BAIui+5Zzd7MpgqucBs+vHvbhzXAc ZcWvkP2hwpgHBfXyfq9P+Q== 0000950137-07-016608.txt : 20071106 0000950137-07-016608.hdr.sgml : 20071106 20071106094807 ACCESSION NUMBER: 0000950137-07-016608 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071101 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071106 DATE AS OF CHANGE: 20071106 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: 071216184 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 c21304e8vk.htm FORM 8-K e8vk
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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
Date of Report: November 1, 2007
(Date of Earliest Event Reported)
Akorn, Inc.
(Exact Name of Registrant as Specified in its Charter)
         
Louisiana   0-13976   72-0717400
(State or other Jurisdiction of
Incorporation)
  (Commission
File Number)
  (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 communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o   Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240. 13e-4(c)
 
 

 


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Item 2.02 Results of Operations and Financial Condition
Item 9.01 Financial Statements and Exhibits
SIGNATURES
Press Release


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Item 2.02 Results of Operations and Financial Condition.          
     On November 1, 2007, Akorn, Inc. (“Akorn”) issued a press release announcing certain results of Akorn’s financial review for the quarter ended September 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 November 1, 2007.

 


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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: November 6, 2007

 

EX-99.1 2 c21304exv99w1.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 Third Quarter 2007 Financial Results
Buffalo Grove, IL, November 1, 2007 – Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the third quarter ended September 30, 2007.
Total revenue for the third quarter 2007 was $15.8 million, an increase of 36% over second quarter 2007 total revenue of $11.6 million, and a 9% increase over third quarter 2006 total revenue of $14.5 million. The revenue increase reflects the impact of the multi-dose Tetanus Diphtheria vaccine product launch as well as the re-launch of IC-Green™. As of September 30, 2007, approximately $1.3 million remained on backorder for IC-Green™.
Gross profit for the third quarter 2007 was $3.0 million as compared to $6.0 million in the third quarter 2006. The aggregate decline in third quarter 2007 gross profit versus the comparative prior year period was due to a sales mix of significantly higher margin products in the comparative prior year period, primarily attributed to the re-launch of Bal-in-Oil. Further, the current year period included introductory pricing levels for the multi-dose Tetanus Diphtheria vaccine, necessary to compete with distributors who are exhausting their on-hand inventories prior to product expiration. Finally, both of our manufacturing facilities incurred production shutdowns in the third quarter 2007.
Selling, general and administrative expenses totaled $5.4 million in the third quarter 2007, an increase of $1.1 million over the comparative prior year period. The majority of this increase is due to the addition of 19 new employees that were hired to expand our sales teams in anticipation of two near-term product launches: Oral Vancomycin and unit dose preservative-free Tetanus Diphtheria vaccine. Research and development expenses were $2.1 million in the third quarter 2007 versus $2.6 million in the comparative prior year period. The net loss available to common stockholders for the third quarter 2007 was $4.7 million or $0.05 per fully diluted share vs. the net loss available to common stockholders of $1.2 million in the third quarter 2006 or $0.02 per fully diluted share.
As of September 30, 2007, the Company had cash and cash equivalents equal to $10.3 million and $10.0 million of undrawn availability under our Credit Agreement. In addition,

 


 

the Company recently announced the pending sale of one million shares of common stock, priced at market, to Serum Institute of India, Ltd.
Highlights for the Third Quarter 2007:
    Biologics and Vaccines Business Segment:
  o   September 5, 2007: Akorn announced the product launch of multi-dose Tetanus Diphtheria vaccine.
    Hospital Drugs and Injectables Business Segment:
  o   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.
 
  o   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.
 
  o   July 30, 2007: Akorn announced the signing of a development and supply agreement with Hyaluron for two injectable ANDA suspension drug products.
 
  o   September 9, 2007: Akorn announced the submission of an ANDA drug product developed jointly with Sofgen Pharmaceuticals for the treatment of nausea and vomiting associated with cancer chemotherapy.
 
  o   October 11, 2007: Akorn announced the signing of an exclusive licensing, development and supply agreement with Sofgen Pharmaceuticals for an ANDA oral drug product for women’s healthcare.
    New Product Development:
  o   July 7, 2007: Akorn-Strides, LLC announced its first ANDA approval for Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 mg/mL.
 
  o   July 27, 2007: Akorn announced FDA approval of Ketotifen Fumarate Ophthalmic Solution, 0.025%.
    Ophthalmic Business Segment:
  o   September 26, 2007: Akorn announced FDA approval for alternate manufacturing site for IC-Green™.

 


 

Arthur S. Przybyl, President and Chief Executive Officer stated, “Our third quarter results highlight the initial launch of our first vaccine product, multi-dose Tetanus Diphtheria (Td) vaccine. First month introductory sales of the Td vaccine were $4.7 million. Gross margins for this product should stabilize at approximately 20%, once inventories of the distributors are exhausted by the end of the first quarter 2008. At the same time, we anticipate the launch of the unit dose preservative-free Td vaccine product. This vaccine will allow us to effectively compete in the hospital market, where we expect to increase our market share at gross margins in the range of 25% — 30%. Manufacture of multi-dose Td vaccine will be discontinued once the unit dose preservative-free Td vaccine is launched.
We continue to add sales representatives in order to enhance sales coverage for two anticipated new product introductions: Oral Vancomycin and unit dose preservative-free Td vaccine. Our hospital sales team currently has 18 representatives and our vaccine sales team has 7 representatives. We expect that by the end of the first quarter 2008, levels of these sales teams will each be at 20 representatives, our target staffing objective.
Product Development partnership alliances continue to grow. We added two new drug products with Cipla and Sofgen, and entered into new partnership agreements with Haemonetics and Hyaluron, for Injectable premix and suspension drug products, respectively.
For our three near-term product approvals, we continue to guide towards the end of 2007 for Oral Vancomycin, the first quarter 2008 for unit dose preservative-free Td vaccine, and the second quarter 2008 for Akten®, our ophthalmic topical anesthetic NDA drug product.”

 


 

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
                 
    SEPTEMBER 30,     DECEMBER 31,  
    2007     2006  
    (UNAUDITED)     (AUDITED)  
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $ 10,260     $ 21,818  
Trade accounts receivable (less allowance for doubtful accounts of $3 and $3, respectively)
    5,645       4,781  
Inventories
    19,749       11,734  
Prepaid expenses and other current assets
    721       1,321  
 
           
TOTAL CURRENT ASSETS
    36,375       39,654  
PROPERTY, PLANT AND EQUIPMENT, NET
    32,648       33,486  
OTHER LONG-TERM ASSETS
               
Intangibles, net
    7,860       8,825  
Other
    993       118  
 
           
TOTAL OTHER LONG-TERM ASSETS
    8,853       8,943  
 
           
TOTAL ASSETS
  $ 77,876     $ 82,083  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Current installments of debt
  $ 309     $ 394  
Trade accounts payable
    12,038       4,719  
Accrued compensation
    944       1,849  
Customer accrued liabilities
    235       391  
Accrued expenses and other liabilities
    1,362       2,900  
 
           
TOTAL CURRENT LIABILITIES
    14,888       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
    16,196       11,769  
 
           
SHAREHOLDERS’ EQUITY
               
Common stock, no par value — 150,000,000 shares authorized; 87,730,355 and
85,990,964 shares issued and outstanding at September 30, 2007 and
December 31, 2006, respectively
    157,887       150,250  
Warrants to acquire common stock
    2,795       4,862  
Accumulated deficit
    (99,002 )     (84,798 )
 
           
TOTAL SHAREHOLDERS’ EQUITY
    61,680       70,314  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 77,876     $ 82,083  
 
           

 


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
                                 
    THREE MONTHS ENDED     NINE MONTHS ENDED  
    SEPTEMBER 30,     SEPTEMBER 30,  
    2007     2006     2007     2006  
Revenues
  $ 15,814     $ 14,490     $ 39,187     $ 56,695  
Cost of sales
    12,846       8,539       30,844       34,056  
 
                       
GROSS PROFIT
    2,968       5,951       8,343       22,639  
Selling, general and administrative expenses
    5,362       4,226       15,793       13,379  
Amortization and write-down of intangibles
    338       345       1,015       1,046  
Research and development expenses
    2,135       2,649       6,307       6,815  
 
                       
TOTAL OPERATING EXPENSES
    7,835       7,220       23,115       21,240  
 
                       
OPERATING (LOSS) / INCOME
    (4,867 )     (1,269 )     (14,772 )     1,399  
Interest Income/(Expense) — net
    140       230       568       (855 )
Debt Retirement Expense
                      (391 )
Other Income/(Expense)
          (28 )     1       (57 )
 
                       
(LOSS)/INCOME BEFORE INCOME TAXES
    (4,727 )     (1,067 )     (14,203 )     96  
Income tax provision
                1        
 
                       
NET (LOSS)/INCOME
    (4,727 )     (1,067 )     (14,204 )     96  
Preferred stock dividends and adjustments
          (182 )           (742 )
 
                       
NET (LOSS)/INCOME AVAILABLE TO COMMON STOCKHOLDERS
  $ (4,727 )   $ (1,249 )   $ (14,204 )   $ (646 )
 
                       
NET (LOSS)/INCOME PER SHARE:
                               
BASIC
  $ (0.05 )   $ (0.02 )   $ (0.16 )   $ (0.01 )
 
                       
DILUTED
  $ (0.05 )   $ (0.02 )   $ (0.16 )   $ (0.01 )
 
                       
SHARES USED IN COMPUTING NET (LOSS)/INCOME PER SHARE:
                               
BASIC
    87,651       76,420       86,971       71,050  
 
                       
DILUTED
    87,651       76,420       86,971       71,050  
 
                       

 


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
                 
    NINE MONTHS  
    ENDED SEPTEMBER 30  
    2007     2006  
OPERATING ACTIVITIES
               
Net (loss) / income
  $ (14,204 )   $ 96  
Adjustments to reconcile net (loss)/income to net cash (used in)/provided by operating activities:
               
Depreciation and amortization
    3,273       2,444  
Amortization of debt discounts
          1,059  
Non-cash stock compensation expense
    2,484       1,524  
Changes in operating assets and liabilities:
               
Trade accounts receivable
    (864 )     (3,717 )
Inventories
    (8,015 )     (142 )
Prepaid expenses and other current assets
    (275 )     218  
Trade accounts payable
    7,319       (1,007 )
Product warranty
          1,131  
Accrued customer liability
    (156 )     403  
Accrued expenses and other liabilities
    (2,443 )     (137 )
 
           
NET CASH (USED IN)/PROVIDED BY OPERATING ACTIVITIES
    (12,881 )     1,872  
INVESTING ACTIVITIES
               
Purchases of property, plant and equipment
    (1,420 )     (3,571 )
Purchase of intangible assets
    (50 )      
 
           
NET CASH USED IN INVESTING ACTIVITIES
    (1,470 )     (3,571 )
FINANCING ACTIVITIES (See Note 1 below)
               
Repayment of long-term debt
    (293 )     (3,009 )
Proceeds from common stock and warrant offering
          21,621  
Proceeds from warrants exercised
    2,507       1,213  
Proceeds under stock option and stock purchase plans
    579       606  
 
           
NET CASH PROVIDED BY FINANCING ACTIVITIES
    2,793       20,431  
(DECREASE)/INCREASE IN CASH AND CASH EQUIVALENTS
    (11,558 )     18,732  
Cash and cash equivalents at beginning of period
    21,818       791  
 
           
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 10,260     $ 19,523  
 
           
Amount paid for interest
  $ 43     $ 577  
Amount paid for income taxes
  $ 3     $ 2  
 
Note 1:   In March 2006, $7,298 in principal and interest related to convertible notes was retired by conversion to the common stock of Akorn, Inc.

 

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