e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED March 31, 2006
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
FOR
THE TRANSITION PERIOD FROM ___ TO ___
COMMISSION FILE NUMBER: 0-13976
AKORN, INC.
(Exact Name of Registrant as Specified in its Charter)
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LOUISIANA
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72-0717400 |
(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification No.) |
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2500 MILLBROOK DRIVE |
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BUFFALO GROVE, ILLINOIS
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60089 |
(Address of Principal Executive Offices)
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(Zip Code) |
(847) 279-6100
(Registrants telephone number)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer (as defined in Exchange Act Rule 12b-2).
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer þ |
Indicate by check mark whether the Registrant is a shell company (as defined in Exchange
Act Rule 12b-2).
Yes o No þ
At April 30, 2006 there were 74,573,700 shares of common stock, no par value,
outstanding.
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Page |
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PART I. FINANCIAL INFORMATION |
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ITEM 1. Financial Statements |
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Condensed Consolidated Balance Sheets-March 31, 2006 and December 31, 2005 |
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3 |
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Condensed Consolidated Statements of Operations-Three months ended March 31, 2006 and 2005 |
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4 |
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Condensed Consolidated Statement of Shareholders Equity-Three months ended March 31, 2006 and 2005 |
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5 |
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Condensed Consolidated Statements of Cash Flows-Three months ended March 31, 2006 and 2005 |
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6 |
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Notes to Condensed Consolidated Financial Statements |
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7 |
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ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations |
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15 |
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ITEM 3. Quantitative and Qualitative Disclosures About Market Risk |
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17 |
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ITEM 4. Controls and Procedures |
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17 |
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PART II. OTHER INFORMATION |
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ITEM 1. Legal Proceedings |
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18 |
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ITEM 1A. Risk Factors |
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18 |
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ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds |
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18 |
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ITEM 3. Defaults Upon Senior Securities |
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18 |
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ITEM 4. Submission of Matters to a Vote of Security Holders |
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18 |
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ITEM 5. Other Information |
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18 |
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ITEM 6. Exhibits |
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19 |
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2
AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
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MARCH 31, |
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DECEMBER 31, |
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2006 |
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2005 |
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(UNAUDITED) |
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(AUDITED) |
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ASSETS |
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|
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CURRENT ASSETS |
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|
Cash and cash equivalents |
|
$ |
24,558 |
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|
$ |
791 |
|
Trade accounts receivable (less
allowance for doubtful accounts of $3
and $13 respectively) |
|
|
2,031 |
|
|
|
3,222 |
|
Inventories |
|
|
10,966 |
|
|
|
10,279 |
|
Prepaid expenses and other current assets |
|
|
1,593 |
|
|
|
1,402 |
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|
|
|
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|
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TOTAL CURRENT ASSETS |
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|
39,148 |
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|
15,694 |
|
PROPERTY, PLANT AND EQUIPMENT, NET |
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|
31,322 |
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|
31,071 |
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OTHER LONG-TERM ASSETS |
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Intangibles, net |
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9,859 |
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|
10,210 |
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Other |
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|
113 |
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|
120 |
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TOTAL OTHER LONG-TERM ASSETS |
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9,972 |
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10,330 |
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TOTAL ASSETS |
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$ |
80,442 |
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$ |
57,095 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES |
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Current installments of debt |
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$ |
373 |
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$ |
7,044 |
|
Trade accounts payable |
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|
2,745 |
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|
3,046 |
|
Accrued compensation |
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|
1,063 |
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|
1,519 |
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Customer accrued liabilities |
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3,115 |
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|
135 |
|
Accrued interest payable |
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|
2,514 |
|
Accrued expenses and other liabilities |
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|
1,180 |
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|
1,202 |
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TOTAL CURRENT LIABILITIES |
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|
8,476 |
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|
15,460 |
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LONG-TERM LIABILITIES |
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|
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Long-term debt, less current installments |
|
|
506 |
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|
602 |
|
Product warranty |
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|
1,159 |
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|
|
|
|
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TOTAL LONG-TERM LIABILITIES |
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|
1,665 |
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|
602 |
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TOTAL LIABILITIES |
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10,141 |
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|
16,062 |
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SHAREHOLDERS EQUITY |
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Common stock, no par value 150,000,000
shares authorized; 74,281,973 and
27,618,745 shares issued and outstanding
at March 31, 2006 and December 31, 2005,
respectively |
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|
122,312 |
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|
67,339 |
|
Series A Preferred Stock, $1.00 par
value, 257,172 shares authorized and
issued, 241,122 shares outstanding at
December 31, 2005 |
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|
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|
27,232 |
|
Series B Preferred Stock, $1.00 par
value, 170,000 shares authorized,
141,000 shares issued, 85,400
outstanding at March 31, 2006 and
106,600 outstanding at December 31, 2005 |
|
|
8,757 |
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|
10,758 |
|
Warrants to acquire common stock |
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|
14,424 |
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|
13,696 |
|
Accumulated deficit |
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|
(75,192 |
) |
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|
(77,992 |
) |
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TOTAL SHAREHOLDERS EQUITY |
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|
70,301 |
|
|
|
41,033 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
80,442 |
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|
$ |
57,095 |
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|
|
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|
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|
See notes to condensed consolidated financial statements.
3
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
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THREE MONTHS ENDED |
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MARCH 31, |
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2006 |
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|
2005 |
|
Revenues |
|
$ |
29,730 |
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$ |
10,181 |
|
Cost of sales |
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|
17,997 |
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|
6,838 |
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GROSS PROFIT |
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|
11,733 |
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|
3,343 |
|
Selling, general and administrative expenses |
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|
4,484 |
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|
3,368 |
|
Amortization and write-down of intangibles |
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|
351 |
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|
379 |
|
Research and development expenses |
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|
2,045 |
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|
1,342 |
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|
|
|
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TOTAL OPERATING EXPENSES |
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|
6,880 |
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|
5,089 |
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OPERATING INCOME (LOSS) |
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|
4,853 |
|
|
|
(1,746 |
) |
Interest expense |
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|
(1,319 |
) |
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|
(526 |
) |
Debt Retirement Expense |
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|
(391 |
) |
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|
Other Income (Expense) |
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|
(17 |
) |
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INCOME (LOSS) BEFORE INCOME TAXES |
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|
3,126 |
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|
(2,272 |
) |
Income tax provision |
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|
15 |
|
|
|
|
|
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|
NET INCOME (LOSS) |
|
|
3,126 |
|
|
|
(2,287 |
) |
Preferred stock dividends and adjustments |
|
|
(326 |
) |
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|
(1,061 |
) |
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|
|
|
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|
NET INCOME (LOSS) AVAILABLE TO COMMON STOCKHOLDERS |
|
$ |
2,800 |
|
|
$ |
(3,348 |
) |
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|
|
|
|
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|
NET INCOME (LOSS) PER SHARE: |
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|
|
|
|
|
|
|
BASIC |
|
$ |
0.05 |
|
|
$ |
(0.13 |
) |
|
|
|
|
|
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|
DILUTED |
|
$ |
0.04 |
|
|
$ |
(0.13 |
) |
|
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|
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|
SHARES USED IN COMPUTING NET INCOME (LOSS) PER SHARE: |
|
|
|
|
|
|
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|
BASIC |
|
|
61,715 |
|
|
|
25,237 |
|
|
|
|
|
|
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|
DILUTED |
|
|
74,980 |
|
|
|
25,237 |
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements.
4
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY
FOR THE THREE MONTHS ENDED MARCH 31, 2006 AND 2005
IN THOUSANDS
(UNAUDITED)
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|
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|
|
|
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|
|
Warrants |
|
|
Retained |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
to acquire |
|
|
Earnings |
|
|
|
|
Three Months Ended March 31, 2006 |
|
Common Stock |
|
|
Preferred |
|
|
Preferred |
|
|
Common |
|
|
(Accumulated |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Stock |
|
|
Stock |
|
|
Stock |
|
|
Deficit) |
|
|
Total |
|
BALANCES AT DECEMBER 31, 2005 |
|
|
27,619 |
|
|
$ |
67,339 |
|
|
$ |
27,232 |
|
|
$ |
10,758 |
|
|
$ |
13,696 |
|
|
$ |
(77,992 |
) |
|
$ |
41,033 |
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,126 |
|
|
|
3,126 |
|
Preferred stock dividends earned |
|
|
|
|
|
|
|
|
|
|
55 |
|
|
|
164 |
|
|
|
|
|
|
|
(219 |
) |
|
|
|
|
Intrinsic value of beneficial
conversion features in convertible
preferred stock |
|
|
|
|
|
|
107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(107 |
) |
|
|
|
|
Conversion of preferred stock into
common stock |
|
|
37,658 |
|
|
|
29,452 |
|
|
|
(27,287 |
) |
|
|
(2,165 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of warrants into common stock |
|
|
788 |
|
|
|
1,188 |
|
|
|
|
|
|
|
|
|
|
|
(1,093 |
) |
|
|
|
|
|
|
95 |
|
Conversion of convertible notes into
common stock |
|
|
3,540 |
|
|
|
7,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,298 |
|
Net proceeds from issuance of common
stock and warrants |
|
|
4,312 |
|
|
|
16,257 |
|
|
|
|
|
|
|
|
|
|
|
1,821 |
|
|
|
|
|
|
|
18,078 |
|
Exercise of stock options |
|
|
356 |
|
|
|
297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
297 |
|
Employee stock purchase plan issuances |
|
|
9 |
|
|
|
41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41 |
|
Amortization of deferred compensation
related to restricted stock awards |
|
|
|
|
|
|
130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
130 |
|
FAS123R share based payment expense |
|
|
|
|
|
|
203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCES AT MARCH 31, 2006 |
|
|
74,282 |
|
|
$ |
122,312 |
|
|
$ |
|
|
|
$ |
8,757 |
|
|
$ |
14,424 |
|
|
$ |
(75,192 |
) |
|
$ |
70,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants |
|
|
Retained |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
Series B |
|
|
to acquire |
|
|
Earnings |
|
|
|
|
Three Months Ended March 31, 2005 |
|
Common Stock |
|
|
Preferred |
|
|
Preferred |
|
|
Common |
|
|
(Accumulated |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Stock |
|
|
Stock |
|
|
Stock |
|
|
Deficit) |
|
|
Total |
|
BALANCES AT DECEMBER 31, 2004 |
|
|
25,133 |
|
|
$ |
59,571 |
|
|
$ |
25,787 |
|
|
$ |
13,109 |
|
|
$ |
14,160 |
|
|
$ |
(65,301 |
) |
|
$ |
47,326 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,287 |
) |
|
|
(2,287 |
) |
Preferred stock dividends earned |
|
|
|
|
|
|
|
|
|
|
391 |
|
|
|
213 |
|
|
|
|
|
|
|
(604 |
) |
|
|
|
|
Intrinsic value of beneficial
conversion features in convertible
preferred stock |
|
|
|
|
|
|
458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(458 |
) |
|
|
|
|
Intrinsic value of beneficial
conversion features in convertible
interest |
|
|
|
|
|
|
98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
98 |
|
Exercise of warrants into common stock |
|
|
50 |
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
|
(64 |
) |
|
|
|
|
|
|
38 |
|
Exercise of stock options |
|
|
161 |
|
|
|
386 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
386 |
|
Employee stock purchase plan issuances |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCES AT MARCH 31, 2005 |
|
|
25,344 |
|
|
$ |
60,615 |
|
|
$ |
26,178 |
|
|
$ |
13,322 |
|
|
$ |
14,096 |
|
|
$ |
(68,650 |
) |
|
$ |
45,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements.
5
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS |
|
|
|
ENDED MARCH 31 |
|
|
|
2006 |
|
|
2005 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
3,126 |
|
|
$ |
(2,287 |
) |
Adjustments to reconcile net income (loss) to net
cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
818 |
|
|
|
1,751 |
|
Amortization of debt discounts |
|
|
1,059 |
|
|
|
253 |
|
Advances to Strides Arcolab Limited |
|
|
|
|
|
|
(1,500 |
) |
Non-cash stock compensation expense |
|
|
333 |
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
|
1,191 |
|
|
|
3,228 |
|
Inventories |
|
|
(687 |
) |
|
|
(272 |
) |
Prepaid expenses and other current assets |
|
|
(184 |
) |
|
|
272 |
|
Trade accounts payable |
|
|
(301 |
) |
|
|
(2,625 |
) |
Product warranty |
|
|
1,159 |
|
|
|
|
|
Accrued customer liability |
|
|
2,980 |
|
|
|
|
|
Accrued expenses and other liabilities |
|
|
(694 |
) |
|
|
105 |
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES |
|
|
8,800 |
|
|
|
(1,075 |
) |
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(718 |
) |
|
|
(83 |
) |
Purchase of intangible asset |
|
|
|
|
|
|
(75 |
) |
|
|
|
|
|
|
|
NET CASH USED IN INVESTING ACTIVITIES |
|
|
(718 |
) |
|
|
(158 |
) |
FINANCING ACTIVITIES (See Note 1 below) |
|
|
|
|
|
|
|
|
Repayment of long-term debt |
|
|
(2,826 |
) |
|
|
(83 |
) |
Proceeds from common stock and warrants offering |
|
|
18,078 |
|
|
|
|
|
Proceeds from warrants exercised |
|
|
95 |
|
|
|
37 |
|
Proceeds under stock option and stock purchase plans |
|
|
338 |
|
|
|
388 |
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY FINANCING ACTIVITIES |
|
|
15,685 |
|
|
|
342 |
|
|
|
|
|
|
|
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
23,767 |
|
|
|
(891 |
) |
Cash and cash equivalents at beginning of period |
|
|
791 |
|
|
|
4,110 |
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
$ |
24,558 |
|
|
$ |
3,219 |
|
|
|
|
|
|
|
|
Amount paid for interest |
|
$ |
542 |
|
|
$ |
25 |
|
Amount paid for income taxes |
|
|
2 |
|
|
|
72 |
|
See notes to condensed consolidated financial statements.
|
|
|
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. (See Note H) |
6
AKORN, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
NOTE A BUSINESS AND BASIS OF PRESENTATION
Business: Akorn, Inc. and its wholly owned subsidiary, Akorn (New Jersey), Inc. (collectively,
the Company) manufacture and market diagnostic and therapeutic pharmaceuticals in specialty areas
such as ophthalmology, rheumatology, anesthesia and antidotes, among others. Customers, including
physicians, optometrists, wholesalers, group purchasing organizations and other pharmaceutical
companies, are served primarily from three operating facilities in the United States. In September
2004, the Company, along with a venture partner, Strides Arcolab Limited (Strides) formed a
mutually owned limited liability company, Akorn-Strides, LLC (the Joint Venture Company). The
accompanying unaudited condensed consolidated financial statements include the accounts of Akorn,
Inc. and Akorn (New Jersey) Inc. as well as the accounts and results of the Joint Venture Company.
Intercompany transactions and balances have been eliminated in consolidation.
Basis of Presentation: These financial statements have been prepared in accordance with
accounting principles generally accepted in the United States of America for interim financial
information and accordingly do not include all the information and footnotes required by accounting
principles generally accepted in the United States of America for complete financial statements.
In the opinion of management, all adjustments (consisting of normal recurring accruals) considered
necessary for a fair presentation have been included in these financial statements. Operating
results for the three-month period ended March 31, 2006 are not necessarily indicative of the
results that may be expected for a full year. For further information, refer to the consolidated
financial statements and footnotes for the year ended December 31, 2005, included in the Companys
Annual Report on Form 10-K.
NOTE B USE OF ESTIMATES
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ materially from those estimates.
Significant estimates and assumptions for the Company relate to the allowance for doubtful
accounts, the allowance for chargebacks, the allowance for rebates, the reserve for slow-moving and
obsolete inventory, the allowance for product returns, the carrying value of intangible assets and
the carrying value of deferred income tax assets.
NOTE C STOCK BASED COMPENSATION
Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123
(revised 2004), Share Based Payment (SFAS 123(R)), applying the modified prospective method.
Prior to the adoption of SFAS 123(R), the Company applied the provisions of APB Opinion No. 25,
Accounting for Stock Issued to Employees, in accounting for its stock-based awards, and
accordingly, recognized no compensation cost for its stock plans other than for its restricted
stock awards.
Under the modified prospective method, SFAS 123(R) applies to new awards and to awards that were
outstanding as of December 31, 2005 that are subsequently vested, modified, repurchased or
cancelled. Compensation expense recognized during the first quarter of 2006 includes the portion
vesting during the period for (1) all share-based payments granted prior to, but not yet vested as
of December 31, 2005, based on the grant date fair value estimated in accordance with the original
provisions of Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based
Compensation (SFAS 123) and (2) all share-based payments granted subsequent to December 31, 2005,
based on the grant-date fair value estimated using the Black-Scholes option-pricing model.
Stock compensation expense of $203,000 was recognized during the first quarter of 2006 of which
$179,000 related to existing stock options granted prior to January 1, 2006 and $24,000 related to
stock options granted during the first quarter of 2006. As a result of the Companys decision to
adopt the modified prospective method, prior period results have not
been restated. For awards issued prior to January 1, 2006, the
Company used the multiple-award method for allocating the
compensation cost to each period. For awards issued on or after
January 1, 2006, concurrent with the adoption of
SFAS 123(R), the Company has elected to use the single-award
method for allocating the compensation cost to each period.
7
The following table illustrates the effect on net income and earnings per share if the Company had
applied the fair value recognition provisions of SFAS 123 for the three months ended March 31,
2005.
|
|
|
|
|
|
|
Three Months |
|
|
|
Ended |
|
|
|
March 31, 2005 |
|
Net income (loss) as reported |
|
|
($2,287 |
) |
Add: stock-based employee compensation expense included in reported net income |
|
|
|
|
Deduct: total stock-based employee compensation expense determined under
fair-value-based method for all awards |
|
|
(287 |
) |
|
|
|
|
Pro forma net income (loss) |
|
|
(2,574 |
) |
Deduct: preferred stock dividends and adjustments |
|
|
(1,061 |
) |
|
|
|
|
Pro forma net loss available for common stockholders |
|
|
($3,635 |
) |
|
|
|
|
Basic and diluted loss per share of common stock |
|
|
|
|
As reported |
|
|
($0.13 |
) |
Pro forma |
|
|
($0.14 |
) |
The weighted-average assumptions used in estimating the fair value of the stock options
granted during the period, along with the weighted-average grant date fair values, were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Three Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
March 31, 2006 |
|
|
March 31, 2005 |
|
|
|
(SFAS 123(R)) |
|
|
(SFAS 123 Pro Forma) |
|
|
|
|
Expected Volatility |
|
|
62 |
% |
|
|
83 |
% |
Expected Life (in years) |
|
|
3.6 |
|
|
|
5.0 |
|
Risk-free interest rate |
|
|
4.6 |
% |
|
|
3.9 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
Fair value per stock option |
|
$ |
2.20 |
|
|
$ |
2.41 |
|
A summary of stock based compensation activity within the Companys stock-based compensation plans
for the three months ended March 31, 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Remaining |
|
|
|
|
|
|
Number of |
|
|
Average |
|
|
Contractual Term |
|
|
Aggregate |
|
|
|
Shares |
|
|
Exercise Price |
|
|
(Years) |
|
|
Intrinsic Value |
|
|
Outstanding at January 1, 2006 |
|
|
3,706 |
|
|
$ |
2.54 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
53 |
|
|
|
4.50 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(600 |
) |
|
|
2.34 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(115 |
) |
|
|
4.95 |
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2006 |
|
|
3,044 |
|
|
$ |
2.41 |
|
|
|
2.80 |
|
|
$ |
7,449 |
|
|
Exercisable at March 31, 2006 |
|
|
2,259 |
|
|
$ |
2.15 |
|
|
|
2.80 |
|
|
$ |
6,126 |
|
|
8
The aggregate intrinsic value for stock options outstanding and exercisable is defined as the
difference between the market value of the Companys stock as of the end of the period and the
exercise price of the stock options. The total intrinsic value of stock options exercised during
the first quarter of 2006 was $1,303,000. As a result of the stock options exercised, the Company
recorded cash received and additional paid-in-capital of $297,000 during the first quarter of 2006.
The following is a summary of nonvested stock option activity (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Grant Date |
|
|
|
Shares |
|
|
Fair Value |
|
|
Nonvested at December 31, 2005 |
|
|
842 |
|
|
$ |
1.94 |
|
Granted |
|
|
52 |
|
|
$ |
2.20 |
|
Vested |
|
|
(75 |
) |
|
$ |
1.01 |
|
Canceled |
|
|
(22 |
) |
|
$ |
1.87 |
|
|
Nonvested at March 31, 2006 |
|
|
797 |
|
|
$ |
2.05 |
|
|
For awards issued prior to January 1, 2006, the
Company used the multiple-award method for allocating the
compensation cost to each period. For awards issued on or after
January 1, 2006, concurrent with the adoption of
SFAS 123(R), the Company has elected to use the single-award
method for allocating the compensation cost to each period.
At
March 31, 2006, there was $681,000 of total unrecognized compensation cost related to
nonvested stock options. This cost will be recognized over 3.0 years.
The Company also grants restricted stock awards to certain employees. Restricted stock awards are
valued at the closing market value of the Companys common stock on the day of grant, and the total
value of the award is recognized as expense ratably over the vesting period of the employees
receiving the grants. The Company did not grant restricted stock awards during the first quarter of
2006. As of March 31, 2006, the total amount of unrecognized compensation expense related to
nonvested restricted stock awards was zero. The Company recognized compensation expense of $130,000
during the first quarter of 2006 on existing restricted stock awards.
NOTE D REVENUE RECOGNITION
The Company recognizes product sales for its ophthalmic and injectable business segments upon
the shipment of goods or upon the acceptance of title and risk of ownership of the goods by the
customer. Revenue is recognized when all obligations of the Company have been fulfilled and
collection of the related receivable is probable.
The contract services segment, which produces products for third party customers based upon
their specifications and at pre-determined prices, also recognizes sales upon the shipment of goods
or upon delivery of the product or service as appropriate. Revenue is recognized when all
obligations of the Company have been fulfilled and collection of the related receivable is
probable.
Provision for estimated doubtful accounts, chargebacks, rebates, discounts and product returns
is made at the time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.
NOTE E ACCOUNTS RECEIVABLE ALLOWANCES & CUSTOMER ACCRUED LIABILITIES
The nature of the Companys business inherently involves, in the ordinary course, significant
amounts and substantial volumes of transactions and estimates relating to allowances for doubtful
accounts, product returns, chargebacks, rebates and discounts given to customers. This is a natural
circumstance of the pharmaceutical industry and not specific to the Company and inherently
lengthens the collection process. Depending on the product, the end-user customer, the specific
terms of national supply contracts and the particular arrangements with the Companys wholesaler
customers, certain rebates, chargebacks and other credits are deducted from the Companys accounts
receivable. The process of claiming these deductions depends on wholesalers reporting to the
Company the amount of deductions that were earned under the respective terms with end-user
customers (which in turn depends on which end-user customer, with different pricing arrangements
might be entitled to a particular deduction). This process can lead to partial payments against
outstanding invoices as the wholesalers take the claimed deductions at the time of payment.
In the first quarter of 2006, the Company implemented a program to reduce wholesaler inventory
stocking levels with significant sales reductions to its major wholesalers. This curtailment in
sales generated a low gross accounts receivable level with these major wholesalers (approximately
$3,558,000) while the Companys liabilities for future wholesaler submission of chargebacks,
rebates and returns are still at a significant level (approximately $6,673,000). Accordingly, the
Company has reclassed this net negative amount of $3,115,000 as a liability on the balance sheet at
March 31, 2006. Details of the gross amounts and reserves for both accounts receivable and the
accrued customer liability are detailed below.
9
The provisions for the following customer reserves are reflected in the accompanying financial
statements as reductions of revenues in the income statement with the exception of the allowance
for doubtful accounts which is reflected as part of selling, general and administrative expense.
The ending reserve amounts are included in the net trade accounts receivable and customer accrued
liabilities in the balance sheet.
Net trade accounts receivable consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Gross Accounts Receivable |
|
$ |
2,376 |
|
|
$ |
12,642 |
|
Less: |
|
|
|
|
|
|
|
|
Allowance for Doubtful Accounts |
|
|
(3 |
) |
|
|
(13 |
) |
Returns Reserve |
|
|
(308 |
) |
|
|
(1,529 |
) |
Discount and Allowances Reserve |
|
|
|
|
|
|
(244 |
) |
Chargeback and Rebates Reserves |
|
|
(34 |
) |
|
|
(7,634 |
) |
|
|
|
|
|
|
|
Net Trade Accounts Receivable |
|
$ |
2,031 |
|
|
$ |
3,222 |
|
|
|
|
|
|
|
|
|
|
|
Customer Accrued Liabilities consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Gross Amount Due From Customers |
|
$ |
3,558 |
|
|
$ |
|
|
Less: |
|
|
|
|
|
|
|
|
Allowance for Doubtful Accounts |
|
|
|
|
|
|
|
|
Customer advance payments and net refunds liability |
|
|
(181 |
) |
|
|
(135 |
) |
Returns Reserve |
|
|
(1,232 |
) |
|
|
|
|
Discount and Allowances Reserve |
|
|
(144 |
) |
|
|
|
|
Chargeback and Rebates Reserves |
|
|
(5,116 |
) |
|
|
|
|
|
|
|
|
|
|
|
Customer Accrued Liability |
|
$ |
(3,115 |
) |
|
$ |
(135 |
) |
|
|
|
|
|
|
|
For the three month periods ended March 31, 2006 and 2005, the Company recorded chargeback and
rebate expense of $3,643,000 and $4,999,000, respectively. This decrease was primarily due to the
reduced sales to wholesalers.
For the three-month periods ended March 31, 2006 and 2005, the Company recorded a provision
for product returns of $893,000 and $514,000, respectively. The increase in the provision was to
recognize unfavorable customer returns experience in the period.
For the three-month periods ended March 31, 2006 and 2005, the Company recorded a net benefit
for doubtful accounts of $67,000 and $69,000, respectively as recoveries exceeded uncollectible
amounts written off.
For the three-month periods ended March 31, 2006 and 2005, the Company recorded a provision
for cash discounts of $590,000 and $179,000, respectively. This increase primarily related to a
cash discount for a large sale of the Companys antidote products (see Managements Discussion and
Analysis of Financial Condition and Results of Operations below).
NOTE F INVENTORIES
The components of inventories are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Finished goods |
|
$ |
3,788 |
|
|
$ |
4,914 |
|
Work in process |
|
|
2,631 |
|
|
|
1,702 |
|
Raw materials and supplies |
|
|
4,547 |
|
|
|
3,663 |
|
|
|
|
|
|
|
|
|
|
$ |
10,966 |
|
|
$ |
10,279 |
|
|
|
|
|
|
|
|
Inventory at March 31, 2006 and December 31, 2005 is reported net of reserves for slow-moving,
unsalable and obsolete items of $932,000 and $916,000, respectively, primarily related to finished
goods. For the three-month periods ended March 31, 2006 and 2005, the Company recorded a provision
of $233,000 and $25,000, respectively. The 2006 increase mainly related to valuation reserves for
certain products in inventory at March 31, 2006.
10
NOTE G PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Land |
|
$ |
396 |
|
|
$ |
396 |
|
Buildings and leasehold improvements |
|
|
9,415 |
|
|
|
9,393 |
|
Furniture and equipment |
|
|
28,129 |
|
|
|
27,866 |
|
Automobiles |
|
|
55 |
|
|
|
55 |
|
|
|
|
|
|
|
|
Sub-total |
|
|
37,995 |
|
|
|
37,710 |
|
Accumulated depreciation |
|
|
(27,346 |
) |
|
|
(26,879 |
) |
|
|
|
|
|
|
|
|
|
|
10,649 |
|
|
|
10,831 |
|
Construction in progress |
|
|
20,673 |
|
|
|
20,240 |
|
|
|
|
|
|
|
|
Property, Plant, & Equipment, net |
|
$ |
31,322 |
|
|
$ |
31,071 |
|
|
|
|
|
|
|
|
Construction in progress primarily represents capital expenditures related to the Companys
Lyophilization project. The Company anticipates completing its lyophilization facility validation
and having a pre-approval inspection (PAI) by the U.S. Food and Drug Administration (FDA) in
the second half of 2006. Future costs are estimated to be approximately $900,000. The Company can
make no assurances that it will be able to complete this project within its estimated timeframe, or
at all, or that material impairment charges will not be required if such completion does not occur
as anticipated. The commissioning of the lyophilization facility is contingent upon a successful
PAI to be conducted by the FDA.
NOTE H FINANCING ARRANGEMENTS
The Companys long-term debt consists of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
2003 Subordinated Notes |
|
$ |
|
|
|
$ |
2,767 |
|
Convertible subordinated debentures |
|
|
|
|
|
|
5,000 |
|
Mortgages payable |
|
|
879 |
|
|
|
938 |
|
|
|
|
|
|
|
|
|
|
|
879 |
|
|
|
8,705 |
|
Less unamortized discount on debt |
|
|
|
|
|
|
(1,059 |
) |
Less current installments of debt |
|
|
(373 |
) |
|
|
(7,044 |
) |
|
|
|
|
|
|
|
Long-term debt |
|
$ |
506 |
|
|
$ |
602 |
|
|
|
|
|
|
|
|
On September 30, 2005, the Company renewed its credit agreement (the Credit Facility) with
LaSalle Bank National Association (LaSalle Bank). The renewal extended the existing Credit
Facility until September 30, 2008 and increased the Revolving Commitment amount (the Revolver)
from $5,000,000 to $10,000,000, as well as made modifications of prior existing covenants and the
addition of a tangible net worth financial covenant. The borrowing rate was reduced to the LaSalle
prime rate (7.75% at March 31, 2006) plus 0.5% from the previous rate of LaSalle prime plus 1.5%.
On March 31, 2006, the Company had $5,621,000 of undrawn availability under the Credit Facility.
On October 7, 2003, the Company issued subordinated promissory notes in the aggregate
principal amount of $2,767,000 (the 2003 Subordinated Notes) along with warrants to purchase
276,714 shares of common stock at an exercise price of $1.10 per share to the John N. Kapoor Trust
dated 9/20/89 (the Kapoor Trust), Arjun C. Waney and Argent Fund Management, Ltd. The 2003
Subordinated Notes were to mature on April 7, 2006 and bore interest at prime plus 1.75%, but
interest payments were prohibited under the terms of the
Companys subordination agreement. With the consent
of LaSalle Bank, the
Company retired the 2003 Subordinated Notes with cash payments totaling $3,288,000 on
March 20, 2006. The unamortized debt discount related to the 2003 Subordinated Notes was $113,000
at December 31, 2005. Related debt discount amortization was $113,000 and $88,000 for the three
months ended March 31, 2006 and 2005, respectively.
In 2001, the
Company entered into a $5,000,000 convertible subordinated debt agreement which included a
$3,000,000 Tranche A note (Tranche A Note) and a $2,000,000 Tranche B note (Tranche B Note)
with the Kapoor Trust (collectively, the Convertible Note Agreement). Under the terms of the
Convertible Note Agreement, both the Tranche A Note and the Tranche B
Note, which were due December 20, 2006, bore interest at prime plus 3% and were issued with detachable warrants
(the Tranche A Warrants and the Tranche B Warrants) to purchase shares of common stock.
11
Interest payments for the Tranche A Note and the Tranche B Note were prohibited under the
terms of a subordination arrangement. The convertible feature of the Convertible Note Agreement, as
amended, allowed for conversion of the subordinated debt plus interest into the Companys common stock, at a
price of $2.28 per share of common stock for the Tranche A Note and $1.80 per share of common stock
for the Tranche B Note. The convertible feature on the accrued interest could generate separately
recordable beneficial conversion amounts when the price of the Companys common stock was higher
than the conversion rate when the interest was accrued. The beneficial conversion amount related to
interest was zero and $98,000 for the three month periods ended March 31, 2006 and 2005,
respectively, and was recorded as an increase to paid-in-capital and as additional debt discount
amortizable over the remaining term of the convertible subordinated debt.
The
Company negotiated an early settlement of the Tranche A Note and the Tranche B Note in March 2006.
The associated principal and accumulated interest of approximately $7,298,000 was retired by
conversion into 3,540,281 shares of the Companys common stock on March 31, 2006. A debt retirement fee of
approximately $391,000 was paid as an inducement to retire these notes prior to the original
maturity date of December 20, 2006.
Unamortized debt discount related to the Tranche A Note and the Tranche B Note was zero and
$428,000 as of March 31, 2006 and December 31, 2005, respectively. Related debt discount
amortization was $428,000 and $165,000 for the three months ended March 31, 2006 and 2005,
respectively.
In June 1998, the Company entered into a $3,000,000 mortgage agreement with Standard Mortgage
Investors, LLC of which there were outstanding borrowings of $879,000 and $938,000 at March 31,
2006 and December 31, 2005, respectively. The principal balance is payable over 10 years, with the
final payment due in June 2008. The mortgage note bears a fixed interest rate of 7.375% and is
secured by the real property located in Decatur, Illinois.
NOTE I COMMON STOCK ISSUANCE
On March 8, 2006 the Company issued 4,311,669 shares of its common stock in a private placement
with various investors at a price of $4.50 per share which included warrants to purchase 1,509,088
additional shares of common stock. The warrants are exercisable for a five year period at an
exercise price of $5.40 per share and may be exercised by cash payment of the exercise price or by
means of a cashless exercise. The aggregate offering price of the private placement was
approximately $19,402,000 and the net proceeds to the Company, after payment of approximately
$1,324,000 of commissions and expenses, was approximately $18,078,000.
The net proceeds of $18,078,000 were allocated based on the relative fair market values of the
common stock and warrants with $16,257,000 allocated to the common stock and $1,821,000 allocated
to the warrants
NOTE J EARNINGS PER COMMON SHARE
Basic net income (loss) per common share is based upon weighted average common shares
outstanding. Diluted net income (loss) per common share is based upon the weighted average number
of common shares outstanding, including the dilutive effect of convertible preferred stock, stock
options, warrants and convertible debt using the treasury stock and if converted methods. However,
for the three-month period ended March 31, 2005, the assumed exercise or conversion of any of these
securities would have been anti-dilutive; and, accordingly, the diluted loss per share equals the
basic loss per share for that period. A reconciliation of the earnings per share data from a basic
to a fully diluted basis is detailed below:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
March 31, |
|
Fully Diluted Earnings Per Share Data |
|
2006 |
|
|
2005 |
|
Net income (loss) available to common stockholders basic |
|
$ |
2,800 |
|
|
$ |
(3,348 |
) |
Preferred stock dividends adjustment |
|
|
55 |
|
|
|
|
|
Adjusted earnings fully diluted basis |
|
|
2,855 |
|
|
|
(3,348 |
) |
|
|
|
|
|
|
|
|
Basic Shares |
|
|
61,715 |
|
|
|
25,237 |
|
Preferred Stock |
|
|
4,897 |
|
|
|
|
|
Warrants |
|
|
6,750 |
|
|
|
|
|
Options |
|
|
1,618 |
|
|
|
|
|
|
|
|
|
|
|
|
Fully Diluted Shares |
|
|
74,980 |
|
|
|
25,237 |
|
|
|
|
|
|
|
|
12
NOTE K INDUSTRY SEGMENT INFORMATION
The Company classifies its operations into three business segments, ophthalmic, injectable and
contract services. The ophthalmic segment manufactures, markets and distributes diagnostic and
therapeutic pharmaceuticals. The injectable segment manufactures, markets and distributes
injectable pharmaceuticals, primarily in niche markets. The contract services segment manufactures
products for third party pharmaceutical and biotechnology customers based on their specifications.
Selected financial information by industry segment is presented below (in thousands).
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED MARCH 31, |
|
|
|
2006 |
|
|
2005 |
|
REVENUES |
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
3,807 |
|
|
$ |
5,096 |
|
Injectable |
|
|
23,897 |
|
|
|
2,901 |
|
Contract Services |
|
|
2,026 |
|
|
|
2,184 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
29,730 |
|
|
$ |
10,181 |
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
998 |
|
|
$ |
1,802 |
|
Injectable |
|
|
10,177 |
|
|
|
1,224 |
|
Contract Services |
|
|
558 |
|
|
|
317 |
|
|
|
|
|
|
|
|
Total gross profit |
|
|
11,733 |
|
|
|
3,343 |
|
Operating expenses |
|
|
6,880 |
|
|
|
5,089 |
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
4,853 |
|
|
|
(1,746 |
) |
Interest & Other income (expense) |
|
|
(1,727 |
) |
|
|
(526 |
) |
|
|
|
|
|
|
|
Income (Loss) before income taxes |
|
$ |
3,126 |
|
|
$ |
(2,272 |
) |
|
|
|
|
|
|
|
The Company manages its business segments to the gross profit level and manages its operating
and other costs on a company-wide basis. Intersegment activity at the gross profit level is
minimal. The Company does not identify assets by segment for internal purposes, as certain
manufacturing and warehouse facilities support more than one segment.
NOTE L COMMITMENTS AND CONTINGENCIES
The FDA issued the Company a Warning Letter in October 2000 following a routine inspection of
its Decatur manufacturing facility. An FDA Warning Letter is intended to provide notice to a
company of violations of the laws administered by the FDA and to elicit voluntary corrective
action. The Warning Letter cited violations of regulatory requirements identified during the 2000
inspection and requested that the Company take corrective actions. Under the terms of the Warning
Letter, the Company was unable to obtain any approvals to market new products and government
agencies were notified of its non-compliant status. Additional FDA inspections in 2002, 2003 and
2004 identified additional and recurring violations resulting in continuance of the Warning Letter.
During this time, the FDA initiated no enforcement action.
Since 2000, and in response to the violations cited by the FDA, the Company has implemented a
comprehensive systematic corrective action plan at its Decatur manufacturing facility. The Company
maintained regular communications with the FDA and provided periodic progress reports.
On December 13, 2005, the FDA notified the Company that it had satisfactorily implemented
corrective actions and the FDA had determined that the Decatur manufacturing facility was in
substantial compliance with cGMP regulations. Consequently, the restrictions of the Warning Letter
were removed and the Company became eligible for new product approvals for products manufactured at
its Decatur manufacturing facility.
While under the Warning Letter restrictions from 2000 to 2005, the Companys inability to
fully utilize the capabilities of the Decatur manufacturing facility had a material adverse effect
on its business, financial condition and results of operations.
The Company anticipates completing its lyophilization facility validation and having a PAI by
the FDA in the second half of 2006. However, the commissioning of the lyophilization facility is
contingent upon a successful PAI to be conducted by the FDA.
13
The Company is a party in legal proceedings and potential claims arising in the ordinary
course of its business. The amount, if any, of ultimate liability with respect to such matters
cannot be determined. Despite the inherent uncertainties of litigation, management of the Company
at this time does not believe that such proceedings will have a material adverse impact on the
financial condition, results of operations, or cash flows of the Company.
NOTE M CUSTOMER AND SUPPLIER CONCENTRATION
The Companys major customer for the three month period ended March 31, 2006 was the United
States Department of Health and Human Services (HHS) which purchased $21,962,000 of the Companys
injectable antidote products in the three month period ended March 31, 2006. The Company did not
sell to HHS in 2005. AmerisourceBergen Health Corporation (Amerisource), Cardinal Health, Inc.
(Cardinal) and McKesson Drug Company (McKesson) are all distributors of the Companys products,
as well as suppliers of a broad range of health care products. These three customers accounted for
19% and 54% of Akorns gross revenues and 9% and 40% of net revenues for the three months ended
March 31, 2006 and 2005, respectively. They accounted for approximately 55% and 58% of the gross
accounts receivable balances as of March 31, 2006 and 2005, respectively. No other customers
accounted for more than 10% of gross sales, net revenues or gross trade receivables for the
indicated dates and periods.
If sales to any of Amerisource, Cardinal or McKesson were to diminish or cease, the Company
believes that the end users of its products would find little difficulty obtaining the Companys
products either directly from the Company or from another distributor.
For the three months ended March 31, 2006, Hameln Pharmaceuticals GmbH and Cardinal Health
PTS, LLC accounted for 38% and 11%, respectively of the Companys purchases. For the three months
ended March 31, 2005, Cardinal Health PTS, LLC accounted for 31% of the Companys purchases.
The Company requires a supply of quality raw materials and components to manufacture and
package pharmaceutical products for its own use and for third parties with which it has contracted.
The principal components of the Companys products are active and inactive pharmaceutical
ingredients and certain packaging materials. Certain of these ingredients and components are
available from only a single source and, in the case of certain of the Companys Abbreviated New
Drug Applications (ANDAs) and New Drug Applications (NDAs), only one supplier of raw materials
has been identified. Because FDA approval of drugs requires manufacturers to specify their proposed
suppliers of active ingredients and certain packaging materials in their applications, FDA approval
of any new supplier would be required if active ingredients or such packaging materials were no
longer available from the specified supplier. The qualification of a new supplier could delay the
Companys development and marketing efforts. If for any reason the Company is unable to obtain
sufficient quantities of any of the raw materials or components required to produce and package its
products, it may not be able to manufacture its products as planned, which could have a material
adverse effect on the Companys business, financial condition and results of operations.
14
Item 2.
AKORN, INC.
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
FORWARD-LOOKING STATEMENTS AND FACTORS AFFECTING FUTURE RESULTS
Certain statements in this Form 10-Q constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act. When used in this document, the words
anticipate, believe, estimate and expect and similar expressions are generally intended to
identify forward-looking statements. Any forward-looking statements, including statements regarding
the intent, belief or expectations of Akorn or its management are not guarantees of future
performance. These statements involve risks and uncertainties and actual results may differ
materially from those in the forward-looking statements as a result of various factors, including
but not limited to:
|
|
|
Our ability to comply with all of the requirements of the FDA, including current Good
Manufacturing Practices regulations; |
|
|
|
|
Our ability to obtain regulatory approvals of, commence operations at and obtain business
for our new lyophilization facility; |
|
|
|
|
Our ability to avoid defaults under debt covenants; |
|
|
|
|
Our ability to generate cash from operations sufficient to meet our working capital requirements; |
|
|
|
|
The effects of federal, state and other governmental regulation on our business; |
|
|
|
|
Our success in developing, manufacturing, acquiring and marketing new products; |
|
|
|
|
The success of our strategic partnerships for the development and marketing of new products; |
|
|
|
|
Our ability to bring new products to market and the effects of sales of such products on our financial results; |
|
|
|
|
The effects of competition from generic pharmaceuticals and from other pharmaceutical companies; |
|
|
|
|
Availability of raw materials needed to produce our products; and |
|
|
|
|
Other factors referred to in this Form 10-Q, our Form 10-K and our other Securities and
Exchange Commission (SEC) filings. |
RESULTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2006 COMPARED TO 2005
The following table sets forth, for the periods indicated, revenues by segment, excluding
intersegment sales (in thousands):
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
|
|
MARCH 31, |
|
|
|
2006 |
|
|
2005 |
|
Ophthalmic segment |
|
$ |
3,807 |
|
|
$ |
5,096 |
|
Injectable segment |
|
|
23,897 |
|
|
|
2,901 |
|
Contract Services segment |
|
|
2,026 |
|
|
|
2,184 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
29,730 |
|
|
$ |
10,181 |
|
|
|
|
|
|
|
|
15
Consolidated revenues increased $19,549,000 or 192.0% in the quarter ended March 31, 2006
compared to the same period in 2005. This was mainly due to the $21,962,000 sale of injectable
antidote products to HHS partially offset by the planned reduction in ophthalmic sales to
wholesalers to reduce wholesaler inventory stocking levels. Our contract services segment revenues
decreased by $158,000 or 7.2% mainly due to reduced first quarter demand for contract manufacturing
and research services.
Consolidated gross profit was $11,733,000 or 39.5% for the first quarter of 2006 as compared
to a gross profit of $3,343,000 or 32.8% in the same period a year
ago mainly due to the sales volume
variation matters for each segment discussed above. We continue to seek margin enhancement opportunities through our
product offerings as well as through cost reductions at our operating facilities.
Selling, general and administrative (SG&A) expenses increased by $1,116,000 or 33.1%, during
the quarter ended March 31, 2006 as compared to the same period in 2005. The key components of this
increase in 2006 were; management bonus expense of $551,000, restricted stock compensation expense
of $130,000 and $203,000 in FAS 123R stock option compensation expense for 2006.
Research and development (R&D) expense increased $703,000 or 52.4% in the quarter, to
$2,045,000 from $1,342,000 for the same period in 2005 mainly due to continued testing and
development of our lyophilization processes ($681,000), increased spending on improvements in
regulatory compliance measures ($349,000), and spending on new product development ($247,000) in
2006. This was partially offset by the reduction of $688,000 in product development expenses for
the Joint Venture Company in the first three months of 2005.
Interest expense for the first quarter of 2006 was $1,319,000 versus $526,000 for the same
period in 2005. The increase compared to the same period in the prior year was due to the
$1,059,000 of amortization of debt discount in accordance with retiring the convertible debt and
subordinated notes in the first quarter of 2006.
For the three-month period ended March 31, 2006 the income tax provision was zero as we are
utilizing prior year tax losses to offset the tax liability on income in the first quarter of 2006.
We reported net income of $3,126,000 for the three months ended March 31, 2006, versus a net
loss of $2,287,000 for the same period in 2005 mainly due to the increase in revenues discussed
above.
FINANCIAL CONDITION AND LIQUIDITY
Overview
During the three month period ended March 31, 2006, we generated $8,800,000 in cash provided
from operations, primarily due to $3,126,000 in net income generated by the increase in sales, a
$3,464,000 change in working capital items mainly due to lower receivables levels with wholesalers
and non-cash expenses of $2,210,000 for the period. Investing activities generated a $718,000
reduction in cash flow mainly due to capital expenditures for production equipment. Financing
activities provided $15,685,000 in cash, due to the $18,078,000 net proceeds from the March 2006
common stock and warrants offering (see Note I), offset by $2,826,000 repayment of long-term debt.
In addition, on March 31, 2006 $7,298,000 in principal and accrued interest on the convertible
notes was retired by conversion into 3,540,281 shares of our common stock (see Note H).
During the three-month period ended March 31, 2005, we used $1,075,000 in cash from
operations, primarily due to the net loss, a decrease in accounts payable and a $1,500,000 advance
to our joint venture partner (Strides) to develop ANDAs, offset by non-cash adjustments for
amortization and depreciation, and by a decrease in accounts receivable. Investing activities
during the three-month period ended March 31, 2005 include a $75,000 licensing fee, as well as
$83,000 of capital expenditures primarily related to the lyophilized (freeze-dried) pharmaceuticals
manufacturing line expansion. Financing activities added $342,000 in cash, due to the proceeds from
stock option and warrant exercises.
As of March 31, 2006, we had $24,558,000 in cash and $5,621,000 of undrawn availability under
our Credit Facility with LaSalle Bank (the Credit Facility).
Facility Expansion
We are in the process of completing an expansion of our Decatur, Illinois manufacturing
facility to add capacity to provide lyophilization manufacturing services, a manufacturing
capability we currently do not have. As of March 31, 2006, we had spent approximately $20,051,000
on the lyophilization expansion and anticipate the need to spend approximately $900,000 of
additional funds to complete the expansion. The majority of the additional spending will be focused
on validation testing of the lyophilization facility as the major capital equipment items are
currently in place.
16
Commissioning of the lyophilization facility in 2006 will be contingent upon a successful
pre-approval inspection to be conducted by the FDA. Manufacturing capabilities for lyophilized
products are subsequently projected to be in service by the second half of 2006.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements in accordance with generally accepted accounting principles
requires management to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses. A summary of our significant accounting policies is included in
Note B Summary of Significant Accounting Policies to our consolidated financial statements, which
are included in our Annual Report on Form 10-K for the year ended December 31, 2005. Certain of our
accounting policies are considered critical, as these policies require significant, difficult or
complex judgments by management, often employing the use of estimates about the effects of matters
that are inherently uncertain. Such policies are summarized in Item 7. Managements Discussion and
Analysis of Financial Condition and Results of Operations of our Annual Report on Form 10-K for
the year ended December 31, 2005. There have been no significant changes in the application of the
critical accounting policies since December 31, 2005.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are no longer adversely affected by increases in market interest rates as our only debt
outstanding is the mortgage on our Decatur property which is set at a fixed rate of 7.375%.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Securities Exchange Act of 1934, as amended (Exchange Act),
reports is recorded, processed, summarized and reported within the periods specified in the SECs
rules and forms and that such information is accumulated and communicated to our management
including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure. As of the end of the period covered by this report, we
carried out an evaluation, under the supervision and with the participation of our management,
including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the
design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and
15d-15(e) of the Exchange Act. Based on that evaluation, the Chief Executive Officer and Chief
Financial Officer concluded that, as of the end of the period covered by this report, our
disclosure controls and procedures are effective in timely communicating to them the material
information relating to us required to be included in our periodic SEC filings.
There were no changes to our internal controls over financial reporting that occurred during
our most recently completed fiscal quarter that materially affected, or are reasonably likely to
materially affect our internal control over financial reporting.
17
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are a party in legal proceedings and potential claims arising in the ordinary course of our
business. The amount, if any, of ultimate liability with respect to such matters cannot be
determined. Despite the inherent uncertainties of litigation, we at this time do not believe that
such proceedings will have a material adverse impact on the financial condition, results of
operations, or cash flows of us.
ITEM 1A. RISK FACTORS
None
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On August 23, 2005, we filed a Registration Statement on Form S-3 (File No. 333-127794) (the S-3)
with the SEC, which was declared effective on September 7, 2005. Pursuant to Rule 429 under the
Securities Act of 1933, the prospectus included in the S-3 is a combined prospectus and relates to
the previously filed Registration Statement on Form S-1 (File No. 333-119168) (the S-1), as to
which the S-3 constitutes Post-Effective Amendment No. 3. Such Post-Effective Amendment became
effective concurrently with the effectiveness of the S-3. The S-3 relates to the resale of
64,964,680 shares, no par value per share, of our common stock by the selling stockholders
identified in the S-3, which have been issued or reserved for issuance upon the conversion or
exercise of presently outstanding shares of our Series A 6.0% Participating Convertible Preferred
Stock (Series A Preferred Stock), shares of Series B 6.0% Participating Convertible Preferred
Stock (Series B Preferred Stock), warrants and convertible notes, including shares estimated to
be issuable in satisfaction of accrued and unpaid dividends and interest on shares of preferred
stock and convertible notes, respectively. Of the 64,964,680 shares of our common stock registered
under the S-3, 60,953,394 of such shares were registered under the S-1. The shares of common stock
registered by the S-3 and the S-1 represent the number of shares that have been issued or are
issuable upon the conversion or exercise of the Series A Preferred Stock, Series B Preferred Stock,
warrants and convertible notes described in the Registration Statement, including shares estimated
to be issuable in satisfaction of dividends accrued and unpaid through December 31, 2007 and
interest accrued and unpaid through December 20, 2006 on such securities.
With respect to the S-1, we estimated the aggregate offering price of the amount registered to be
$182,246,053, which was derived from the average of the bid and asked prices of our common stock on
September 17, 2004, as reported on the OTC Bulletin Board(R). With respect to the S-3, we estimated
the aggregate offering price of the amount registered to be $10,870,585, which was derived from the
average of the high and low prices of our common stock as reported on the American Stock Exchange
on August 18, 2005. Such amounts were estimated solely for the purpose of calculating the amount of
the registration fee pursuant to Rule 457(h) under the Securities Act of 1933. As of April 30,
2006, we are aware of the sale of 3,694,834 shares of common stock by selling stockholders under
the S-3 or the S-1. We do not know at what price such shares were sold, or how many shares of
common stock will be sold in the future or at what price. We have not and will not receive any of
the proceeds from the sale of the shares by the selling stockholders. The selling stockholders will
receive all of the proceeds from the sale of the shares and will pay all underwriting discounts and
selling commissions, if any, applicable to the sale of the shares. We will, in the ordinary course
of business, receive proceeds from the issuance of shares upon exercise of the warrants described
in the S-3 or the S-1, which we will use for working capital and other general corporate purposes.
ITEM 3. DEFAULT UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5. OTHER INFORMATION
None
18
ITEM 6. EXHIBITS
Those exhibits marked with an asterisk (*) refer to exhibits filed herewith. The other exhibits are
incorporated herein by reference, as indicated in the following list.
|
|
|
Exhibit No. |
|
Description |
(3.1)
|
|
Restated Articles of Incorporation of Akorn, Inc. dated September 16, 2004, incorporated by reference to
Exhibit 3.1 to Akorn Inc.s Registration Statement on Form S-1 filed on September 21, 2004. |
|
|
|
(3.2)
|
|
Amendment and Restated By-laws of Akorn, Inc. incorporated by reference to Exhibit 3.2 to Akorn, Inc.s
Registration Statement on Form S-1 filed on June 14, 2005. |
|
|
|
(3.3)
|
|
Amended to By-laws of Akorn, Inc. incorporated by reference to Exhibit 3.1 to the Akorn, Inc.s report on
Form 8-K filed on March 31, 2006. |
|
|
|
(4.1)
|
|
First Amendment dated October 7, 2003 to Registration Rights Agreement dated July 12, 2001 between Akorn,
Inc. and The John N. Kapoor Trust dated 9/20/89, incorporated by reference to Exhibit 4.1 to Akorn, Inc.s
report on Form 8-K filed on October 24, 2003. |
|
|
|
(4.2)
|
|
Form of Warrant Certificate, incorporated by reference to Exhibit 4.2 to Akorn, Inc.s report on Form 8-K
filed on October 24, 2003. |
|
|
|
(4.3)
|
|
Form of Warrant Agreement dated October 7, 2003 between Akorn, Inc. and certain investors, incorporated by
reference to Exhibit 4.3 to Akorn, Inc.s report on Form 8-K filed on October 24, 2003. |
|
|
|
(4.4)
|
|
Warrant Agreement dated October 7, 2003 between Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89
issued with respect to New Credit Facility guaranty, incorporated by reference to Exhibit 4.4 to Akorn,
Inc.s report on Form 8-K filed on October 24, 2003. |
|
|
|
(4.5)
|
|
Warrant Agreement dated October 7, 2003 between Akorn, Inc. and Arjun C. Waney issued with respect to New
Credit Facility guaranty, incorporated by reference to Exhibit 4.5 to Akorn, Inc.s report on Form 8-K filed
on October 24, 2003. |
|
|
|
(4.6)
|
|
Warrant Agreement dated October 7, 2003 between Akorn, Inc. and The John N. Kapoor Trust dated 9/20/89
issued with respect to the Notes, incorporated by reference to Exhibit 4.6 to Akorn, Inc.s report on Form
8-K filed on October 24, 2003. |
|
|
|
(4.7)
|
|
Warrant Agreement dated October 7, 2003 between Akorn, Inc. and Arjun C. Waney issued with respect to the
Notes, incorporated by reference to Exhibit 4.7 to the Akorn, Inc.s report on Form 8-K filed on October 24,
2003. |
|
|
|
(4.8)
|
|
Warrant Agreement dated October 7, 2003 between Akorn, Inc. and Argent Fund Management Ltd. issued with
respect to the Notes, incorporated by reference to Exhibit 4.8 to Akorn, Inc.s report on Form 8-K filed on
October 24, 2003. |
|
|
|
(4.9)
|
|
Registration Rights Agreement dated October 7, 2003 among Akorn, Inc. and certain investors, incorporated by
reference to Exhibit 4.9 to Akorn, Inc.s report on Form 8-K filed on October 24, 2003. |
|
|
|
(4.10)
|
|
Form of Subscription Agreement between Akorn, Inc. and certain investors, incorporated by reference to
Exhibit 4.1 to Akorn, Inc.s report on Form 8-K filed on August 24, 2004. |
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(4.11)
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Form of Common Stock Purchase Warrant between Akorn, Inc. and certain investors, incorporated by reference
to Exhibit 4.2 to Akorn, Inc.s report on Form 8-K filed on August 24, 2004. |
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(4.12)
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Warrant Purchase and Registration Agreement dated June 18, 2003 between Akorn Inc. and AEG Partners LLC,
incorporated by reference to Exhibit 4.1 to Akorn, Inc.s report on Form 8-K filed on August 27, 2004. |
|
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(4.13)
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Stock Registration Rights Agreement dated November 15, 1990 between Akorn, Inc. and The John N. Kapoor Trust
dated 9/20/89, incorporated by reference to Exhibit 4.12 to Akorn, Inc.s Registration Statement on Form S-1
filed on September 21, 2004. |
19
|
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Exhibit No. |
|
Description |
(4.14)
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Stock Purchase Agreement dated November 15, 1990 between Akorn, Inc. and The John N. Kapoor Trust dated
9/20/89, incorporated by reference to Exhibit 4.13 to Akorn, Inc.s Registration Statement on Form S-1 filed
on September 21, 2004. |
|
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(4.15)
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Form of Securities Purchase Agreement dated March 1, 2006 between Akorn, Inc. and certain investors,
incorporated by reference to Exhibit 4.1 to Akorn Inc.s report on Form 8-K filed March 7, 2006. |
|
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(4.16)
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Form of Warrant issued in connection with the Securities Purchase Agreement dated March 1, 2006,
incorporated by reference to Exhibit 4.2 to Akorn, Inc.s report on Form 8-K filed on March 7, 2006. (All
warrants are dated March 8, 2006. Please see Exhibit 99.1 of Akorn, Inc.s report on Form 8-K filed March
14, 2006, which is hereby incorporated by reference, for a schedule setting forth the other material details
for each of the warrants.) |
|
|
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(10.1)
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|
Amendment, Waiver and Consent to Credit Agreement dated March 1, 2006, among LaSalle Bank, the lenders,
Akorn, Inc. and Akorn (New Jersey) Inc. incorporated by reference to Exhibit 10.1 to Akorn, Inc.s report on
Form 8-K filed March 7, 2006. |
|
|
|
(10.2)
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|
Waiver and Consent to Credit Agreement dated March 20, 2006, among Akorn, Inc., LaSalle Bank, the financial
institutions party thereto and Akorn (New Jersey), Inc., incorporated by reference to Exhibit 10.1 to Akorn,
Inc.s report on Form 8-K filed March 24, 2006. |
|
|
|
(10.3)
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|
Waiver and Consent to Credit Agreement dated March 31, 2006, between Akorn Inc., LaSalle Bank, the financial
institutions party thereto and Akorn (New Jersey), Inc., incorporated by reference to Exhibit 10.1 to Akorn,
Inc.s report on Form 8-K filed March 31, 2006. |
|
|
|
(10.4)
|
|
Executive Employment Agreement dated April 24, 2006, between Akorn, Inc. and Arthur S. Przybyl incorporated
by reference to Exhibit 10.1 to Akorn, Inc.s report on Form 8-K filed April 24, 2006. |
|
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|
(10.5)
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|
Executive Bonus Agreement dated April 27, 2006, between Akorn, Inc. and Arthur S. Przybyl incorporated by
reference to Exhibit 10.2 to Akorn, Inc.s report on Form 8-K filed April 24, 2006. |
|
|
|
(10.6)
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|
Executive Bonus Agreement dated April 27, 2006, between Akorn, Inc. and Jeffrey A. Whitnell incorporated by
reference to Exhibit 10.3 to Akorn, Inc.s report on Form 8-K filed April 24, 2006. |
|
|
|
(31.1)*
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 |
|
|
|
(31.2)*
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 |
|
|
|
(32.1)*
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of
the Sarbanes-Oxley Act of 2002 |
|
|
|
(32.2)*
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of
the Sarbanes-Oxley Act of 2002 |
20
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 thereunto duly authorized.
|
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|
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AKORN, INC.
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/s/ JEFFREY A. WHITNELL
|
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Jeffrey A. Whitnell |
|
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Sr. Vice President, Chief Financial Officer
(Duly Authorized and Principal Financial Officer) |
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|
Date: May 12, 2006
21