-----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, Omu2wwnd+4gGuK8R4t+4gMW8P8kIxQu6OHAnjDNPQ9HNE5Nan9vYtrxygXRFoav6 Wn1357F0XBRotCpjNy5f3g== 0001157523-09-007908.txt : 20091110 0001157523-09-007908.hdr.sgml : 20091110 20091110090543 ACCESSION NUMBER: 0001157523-09-007908 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20091110 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091110 DATE AS OF CHANGE: 20091110 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: 091170434 BUSINESS ADDRESS: STREET 1: 1925 W. FIELD COURT, SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 1925 W. FIELD COURT, SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 8-K 1 a6096130.htm AKORN, INC. 8-K


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: November 10, 2009
(Date of Earliest Event Reported)


Akorn, Inc.
(Exact Name of Registrant as Specified in its Charter)

Louisiana

001-32360

72-0717400

(State or other
Jurisdiction of
Incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)


1925 W. Field Court, Suite 300
Lake Forest, Illinois  60045
(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):

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))


Item 2.02       Results of Operations and Financial Condition.

On November 10, 2009, Akorn, Inc. (“Akorn”) issued a press release announcing financial results for the quarter ended September 30, 2009.  A copy of the press release is furnished as Exhibit 99.1 to this report.

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 issued by Akorn, Inc., dated November 10, 2009, announcing results for the quarter ended September 30, 2009.


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/ Timothy A. Dick

Timothy A. Dick

Chief Financial Officer

 

Date:

November 10, 2009

EX-99.1 2 a6096130ex99_1.htm EXHIBIT 99.1

Exhibit 99.1

Akorn Reports Third Quarter 2009 Financial Results;
Launches Two New Products:
Ketorolac Tromethamine Ophthalmic and Hydralazine HCL

LAKE FOREST, Ill.--(BUSINESS WIRE)--November 10, 2009--Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the third quarter ended September 30, 2009.

Consolidated revenue for the third quarter 2009 was $19.4 million, versus $31.9 million in the third quarter 2008 representing a decrease of approximately 39%. The decrease was due to lower sales of tetanus-diphtheria (“Td”) and flu vaccines and overall lower sales to wholesalers as part of an effort to reduce wholesaler inventory levels. Ophthalmic segment revenue decreased by $0.3 million or 6%, primarily due to targeted wholesaler reductions in stocking levels. Hospital drugs and injectables segment revenue decreased $3.1 million or 49%, reflecting the targeted wholesaler reduction in stocking levels. Vaccine revenue for this quarter decreased by $8.5 million versus the prior year period primarily due to stronger third quarter 2008 sales resulting from the introduction of a single dose vial Td vaccine and a flu vaccine supply shortage this quarter. As previously disclosed, the Company does not intend to distribute flu vaccine after the 2009 flu season. Contract manufacturing revenue decreased by $0.6 million or 25%, mainly due to decreased order volumes on ophthalmic contract products.

Consolidated gross profit was $2.7 million or 13.9% of revenue for the third quarter of 2009 as compared to a gross profit of $9.9 million or 31.1% of revenue in the same period a year ago. The decrease in third quarter 2009 gross profit compared to the prior year period is primarily due to lower vaccine sales and an increase in Td vaccine unit cost. Also contributing to the decrease were the lower hospital drug and injectable and ophthalmic sales and a corresponding negative impact on manufacturing capacity utilization.

During the third quarter of 2009, the Company recognized equity earnings totaling $0.5 million from its investment in the Akorn-Strides, LLC joint venture and marketing fee revenue of $0.3 million for its commission on sales of joint venture products. The joint venture recognized net sales of approximately $3.8 million during third quarter 2009. Joint venture sales increased $1.9 million over the second quarter 2009 as a result of a full quarter of sales of injectable Vancomycin, which launched in June 2009.

The Company’s net loss was approximately $5.1 million in the third quarter 2009 compared to a net profit of $2.4 million in the third quarter 2008. This reflects the revenue and gross profit decreases and a $1.1 million charge for the change in the fair value of warrants issued in conjunction with the Company’s renegotiated revolving line of credit and subordinated debt, offset by a $1.0 million decrease in selling, general and administrative expense compared to the prior year period resulting from targeted cost reductions. Adjusted EBITDA (a non-GAAP financial measure defined below) for third quarter 2009 was a negative $1.6 million compared with a positive $4.4 million Adjusted EBITDA in the prior year period.


Third quarter cash flow from operating activities was a use of $0.7 million. The revolving line of credit ended the quarter with a balance of $7.5 million compared to $5.5 million on June 30, 2009, while the cash balance ended at $2.0 million on September 30, 2009 compared with $1.0 million on June 30, 2009.

Akorn also announces the launch of the generic version of Acular® (Ketorolac Tromethamine Ophthalmic), a drug with estimated brand sales of $119 million in 2008 according to IMS data. In addition, the company launched Hydralazine Hydrochloride, an existing generic, with estimated sales of $23 million in 2008 according to IMS data.

Raj Rai, Interim Chief Executive Officer said, “We are very pleased with the progress we have made this quarter. While we are on track to achieve the operational objectives we initiated in the second quarter, we are transitioning the company to generate higher margins from the sale of our core ophthalmic and hospital products and positive cash flow in the fourth quarter.”

Rai further stated, “We are pleased to announce the launch of two new generic products, Ketorolac Tromethamine and Hydralazine HCL. These products, in addition to the products launched in the third quarter, will serve as building blocks to the future growth of the company.”

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.

This press release includes statements that may constitute "forward-looking statements", including with regard to the company's future operations and its earnings expectations. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. 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. Factors that could cause or contribute to such differences include, but are not limited to: 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. These cautionary statements should be considered in connection with any subsequent written or oral forward-looking statements that may be made by the company or by persons acting on its behalf and in conjunction with its periodic SEC filings. 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. Other factors besides those listed there could also adversely affect our results.


Non-GAAP Financial Measures

In addition to reporting all financial information required in accordance with generally accepted accounting principles (GAAP), Akorn is also reporting Adjusted EBITDA, which is a non-GAAP financial measure. Since Adjusted EBITDA is not a GAAP financial measure, it should not be used in isolation or as a substitute for consolidated statements of operations and cash flow data prepared in accordance with GAAP. In addition, Akorn’s definition of Adjusted EBITDA may not be comparable to similarly titled non-GAAP financial measures reported by other companies. For a full reconciliation of Adjusted EBITDA to net income (loss), please see the attachments to this earnings release.

Adjusted EBITDA, as defined by the Company, is calculated as follows:

Net income/(loss), plus:

  • Interest income/(expense), net
  • Provision for income taxes
  • Depreciation and amortization
  • Non-cash expenses, such as share-based compensation expense and changes in the fair value of warrants
  • Non-recurring operating expenses, such as supply agreement termination expenses

The Company believes that Adjusted EBITDA is a meaningful indicator, to both Company management and investors, of the past and expected ongoing operating performance of the Company. EBITDA is a commonly used and widely accepted measure of financial performance. Adjusted EBITDA is deemed by the Company to be a useful performance indicator because it includes an add back of non-cash and non-recurring operating expenses which have little to no bearing on cash flows and may be subject to uncontrollable factors not reflective of the Company’s true operational performance (i.e. fair value adjustments to the carrying value of stock warrants liability).

While the Company uses Adjusted EBITDA in managing and analyzing its business and financial condition and believes it to be useful to investors in their evaluating the Company’s performance, Adjusted EBITDA has certain shortcomings. Specifically, Adjusted EBITDA does not take into account the impact of capital expenditures on the liquidity or GAAP financial performance of the company and likewise omits share-based compensation expenses, which may vary over time and may represent a material portion of overall compensation expense. Accordingly, the Company’s management utilizes comparable GAAP financial measures to evaluate the business in conjunction with Adjusted EBITDA and encourages investors to do likewise.


         
AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS, EXCEPT SHARE DATA
 
September 30, December 31,
2009 2008
(Unaudited)  
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 2,018 $ 1,063

Trade accounts receivable (less allowance for doubtful accounts of $2 and $22, respectively)

11,360 6,529
Other receivable - 1,221
Inventories 17,409 30,163
Prepaid expenses and other current assets   485   1,770
TOTAL CURRENT ASSETS 31,272 40,746
PROPERTY, PLANT AND EQUIPMENT, NET 32,169 34,223
OTHER LONG-TERM ASSETS
Intangibles, net 5,033 6,017
Deferred financing costs 4,060 272
Other   1,892   1,071
TOTAL OTHER LONG-TERM ASSETS   10,985   7,360
TOTAL ASSETS $ 74,426 $ 82,329
 
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Trade accounts payable $ 4,458 $ 8,795
Accrued compensation 1,469 1,070
Accrued expenses and other liabilities 3,856 2,906
Short-term subordinated debt - related party - 5,332
Revolving line of credit - related party 7,509 -
Warrants liability - related party 6,654 -
Supply agreement termination costs   1,500   -
TOTAL CURRENT LIABILITIES 25,446 18,103
LONG-TERM LIABILITIES
Lease incentive obligations 1,350 1,484
Product warranty liability 1,299 1,299
Subordinated note - related party   5,853   -
TOTAL LONG-TERM LIABILITIES   8,502   2,783
TOTAL LIABILITIES   33,948   20,886
SHAREHOLDERS' EQUITY

Common stock, no par value -- 150,000,000 shares authorized, 90,340,678 and 90,072,662 shares issued and outstanding at September 30, 2009 and December 31, 2008, respectively

173,304 170,617
Warrants to acquire common stock 1,821 2,731
Accumulated deficit   (134,647)   (111,905)
TOTAL SHAREHOLDERS' EQUITY   40,478   61,443
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 74,426 $ 82,329
 

 
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
           
 
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2009 2008 2009 2008
 
Revenues $ 19,371 $ 31,874 $ 57,711 $ 67,562
Cost of revenue   16,686     21,968     47,997     49,082  
GROSS PROFIT 2,685 9,906 9,714 18,480
 
Selling, general and administrative expenses 5,187 6,199 18,016 18,370
Supply agreement termination expenses - - 5,929 -
Amortization of intangibles 320 339 1,234 1,016
Research and development expenses   1,013     1,143     3,681     4,744  
TOTAL OPERATING EXPENSES   6,520     7,681     28,860     24,130  
 
OPERATING INCOME (LOSS) (3,835 ) 2,225 (19,146 ) (5,650 )
 
Write-off and amortization of deferred financing costs (187 ) - (1,739 ) -
Interest expense, net (441 ) (295 ) (1,095 ) (579 )
Equity in earnings of unconsolidated joint venture 484 447 672 447
Change in fair value of warrants liability (1,122 ) - (1,432 ) -
Other income (expense)   -     24     -     (177 )
INCOME (LOSS) BEFORE INCOME TAXES (5,101 ) 2,401 (22,740 ) (5,959 )
Income tax provision   -     -     2     3  
NET INCOME (LOSS) $ (5,101 ) $ 2,401   $ (22,742 ) $ (5,962 )
 
NET INCOME (LOSS) PER SHARE:
BASIC $ (0.06 ) $ 0.03   $ (0.25 ) $ (0.07 )
DILUTED $ (0.06 ) $ 0.03   $ (0.25 ) $ (0.07 )
 

SHARES USED IN COMPUTING NET INCOME (LOSS) PER SHARE:

BASIC   90,303     89,250     90,209     89,169  
DILUTED   90,303     90,065     90,209     89,169  
 

 
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
IN THOUSANDS (UNAUDITED)
             
 
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2009 2008 2009 2008
OPERATING ACTIVITIES
Net income (loss) $ (5,101 ) $ 2,401 $ (22,742 ) $ (5,962 )

Adjustments to reconcile net income (loss) to net cash used in operating activities:

Depreciation and amortization 1,270 1,126 4,118 3,348
Write-off and amortization of deferred financing fees 187 - 1,739 -
Non-cash stock compensation expense 432 572 1,675 1,821
Non-cash supply agreement termination expense - - 1,051 -
Non-cash change in fair value of warrants liability 1,122 - 1,432 -
Gain on disposal of assets - (25 ) - (25 )
Equity in earnings of unconsolidated joint venture (484 ) (447 ) (672 ) (447 )
Changes in operating assets and liabilities:
Trade accounts receivable (2,316 ) (5,631 ) (4,831 ) (11,620 )
Inventories 7,198 (3,058 ) 12,754 2,662
Prepaid expenses and other current assets 654 112 1,228 252
Other long-term assets - - - 1,246
Supply agreement termination liabilities (3,250 ) - 1,500 -
Trade accounts payable (781 ) 2,988 (4,337 ) (6,651 )
Accrued expenses and other liabilities   332     719     1,736     1,081  
NET CASH USED IN OPERATING ACTIVITIES (737 ) (1,243 ) (5,349 ) (14,295 )
 
INVESTING ACTIVITIES
Purchases of property, plant and equipment (280 ) (1,322 ) (922 ) (2,742 )
Purchase of product licensing rights - - (250 ) -
Proceeds from sale of fixed assets   -     74     -     74  
NET CASH USED IN INVESTING ACTIVITIES (280 ) (1,248 ) (1,172 ) (2,668 )
 
FINANCING ACTIVITIES
Repayment of long-term debt - - - (208 )
Restricted cash for revolving credit agreement - - - (2,050 )

Loan origination fees - revolving line of credit & subordinated note

(43 ) - (1,356 ) -
Proceeds from (repayments of) line of credit 2,000 (3,931 ) 7,509 5,727
Proceeds from warrants exercised - - - 37
Proceeds from subordinated note - 5,000 - 5,000
Proceeds under stock option and stock purchase plans   59     143     1,323     599  
NET CASH PROVIDED BY FINANCING ACTIVITIES   2,016     1,212     7,476     9,105  
 

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

999 (1,279 ) 955 (7,858 )
Cash and cash equivalents at beginning of period   1,019     1,369     1,063     7,948  
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 2,018   $ 90   $ 2,018   $ 90  
 

 
AKORN, INC.
RECONCILIATION OF NET INCOME (LOSS) TO NON-GAAP ADJUSTED EBITDA
IN THOUSANDS (UNAUDITED)
           
 
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
2009 2008 2009 2008
 
NET INCOME (LOSS) $ (5,101 ) $ 2,401 $ (22,742 ) $ (5,962 )
 
ADJUSTMENTS TO ARRIVE AT EBITDA:
Depreciation and amortization 1,270 1,126 4,118 3,348
Interest expense, net 441 295 1,095 579
Income tax provision   -     -   2     3  
EBITDA $ (3,390 ) $ 3,822 $ (17,527 ) $ (2,032 )
 
NON-RECURRING & NON-CASH OPERATING EXPENSES:
Non-cash stock compensation expense 432 572 1,675 1,821
Change in fair value of warrants liability 1,122 - 1,432 -
Write-off and amortization of deferred financing costs 187 - 1,739 -
Supply agreement termination expense   -     -   5,929     -  
ADJUSTED EBITDA $ (1,649 ) $ 4,394 $ (6,752 ) $ (211 )

CONTACT:
Akorn, Inc.
Tim Dick, Chief Financial Officer
(847) 279-6100

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