10-Q
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, 2009
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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: 001-32360
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
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(I.R.S. Employer |
Incorporation or Organization)
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Identification No.) |
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1925 W FIELD CT STE 300 |
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LAKE FOREST, ILLINOIS
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60045 |
(Address of Principal Executive Offices)
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(Zip Code) |
(847) 279-6100
(Registrants telephone number, including area code)
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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
Yes
þ
No o
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or
a smaller reporting company. See the definitions of large accelerated filer, accelerated filer
and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act).
Yes
o
No þ
At May 7, 2009 there were 90,229,618 shares of common stock, no par value, outstanding.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS, EXCEPT SHARE DATA
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MARCH 31, |
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DECEMBER 31, |
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2009 |
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2008 |
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(UNAUDITED) |
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(AUDITED) |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
4,681 |
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$ |
1,063 |
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Trade accounts receivable (less allowance for doubtful accounts
of $29 and $22, respectively |
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12,677 |
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6,529 |
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Other receivable |
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1,221 |
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Inventories |
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29,666 |
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30,163 |
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Prepaid expenses and other current assets |
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1,107 |
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1,770 |
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TOTAL CURRENT ASSETS |
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48,131 |
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40,746 |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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33,554 |
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34,223 |
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OTHER LONG-TERM ASSETS |
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Intangibles, net |
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5,442 |
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6,017 |
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Deferred financing costs |
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1,450 |
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272 |
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Other |
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970 |
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1,071 |
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TOTAL OTHER LONG-TERM ASSETS |
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7,862 |
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7,360 |
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TOTAL ASSETS |
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$ |
89,547 |
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$ |
82,329 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES |
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Trade accounts payable |
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$ |
12,788 |
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$ |
8,795 |
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Accrued compensation |
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1,185 |
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1,070 |
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Accrued expenses and other liabilities |
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2,934 |
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2,906 |
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Short term subordinated debt related party |
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5,532 |
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5,332 |
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Revolving line of credit related party |
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5,509 |
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Supply agreement termination costs, current portion |
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3,250 |
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TOTAL CURRENT LIABILITIES |
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31,198 |
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18,103 |
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LONG-TERM LIABILITIES |
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Lease incentive obligation |
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1,439 |
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1,484 |
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Product warranty liability |
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1,299 |
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1,299 |
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Supply agreement termination costs |
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1,500 |
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TOTAL LONG-TERM LIABILITIES |
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4,238 |
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2,783 |
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TOTAL LIABILITIES |
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35,436 |
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20,886 |
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SHAREHOLDERS EQUITY |
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Common stock, no par value 150,000,000 shares authorized;
90,134,548 and 90,072,662 shares issued and outstanding at
March 31, 2009 and December 31, 2008, respectively |
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171,567 |
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170,617 |
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Warrants to acquire common stock |
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2,731 |
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2,731 |
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Warrants to be issued |
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2,409 |
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Accumulated deficit |
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(122,596 |
) |
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(111,905 |
) |
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TOTAL SHAREHOLDERS EQUITY |
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54,111 |
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61,443 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
89,547 |
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$ |
82,329 |
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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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2009 |
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2008 |
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Revenues |
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$ |
22,040 |
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$ |
14,459 |
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Cost of sales |
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16,678 |
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10,712 |
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GROSS PROFIT |
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5,362 |
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3,747 |
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Selling, general and administrative expenses |
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6,997 |
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6,257 |
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Supply agreement termination expenses |
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5,830 |
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Amortization of intangibles |
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575 |
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339 |
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Research and development expenses |
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977 |
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2,376 |
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TOTAL OPERATING EXPENSES |
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14,379 |
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8,972 |
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OPERATING LOSS |
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(9,017 |
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(5,225 |
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Interest expense, net |
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(278 |
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(115 |
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Write off of
deferred financing costs |
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(1,454 |
) |
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Other income (expense) |
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60 |
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(201 |
) |
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LOSS BEFORE INCOME TAXES |
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(10,689 |
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(5,541 |
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Income tax provision |
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2 |
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3 |
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NET LOSS |
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$ |
(10,691 |
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$ |
(5,544 |
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NET LOSS PER SHARE: |
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BASIC |
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$ |
(0.12 |
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$ |
(0.06 |
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DILUTED |
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$ |
(0.12 |
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$ |
(0.06 |
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SHARES USED IN COMPUTING NET LOSS PER SHARE: |
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BASIC |
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90,104 |
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89,053 |
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DILUTED |
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90,104 |
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89,053 |
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See notes to condensed consolidated financial statements.
4
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY
FOR THE THREE MONTHS
ENDED MARCH 31, 2009 AND 2008
UNAUDITED
(In Thousands)
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Warrants to |
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acquire |
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Warrants |
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Common Stock |
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Common |
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to be |
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Accumulated |
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Three Months Ended March 31, 2009 |
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Shares |
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Amount |
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Stock |
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Issued |
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Deficit |
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Total |
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BALANCES AT DECEMBER 31, 2008 |
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90,073 |
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$ |
170,617 |
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$ |
2,731 |
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$ |
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$ |
(111,905 |
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$ |
61,443 |
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Net loss |
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(10,691 |
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(10,691 |
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Warrants to be issued |
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2,409 |
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2,409 |
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Employee stock purchase plan issuances |
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19 |
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42 |
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42 |
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Amortization of deferred compensation
related to restricted stock awards |
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43 |
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160 |
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160 |
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Restricted stock awards vested net of
amounts
withheld for payment of
employee tax liability |
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(47 |
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(47 |
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Stock-based compensation expense |
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795 |
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795 |
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BALANCES AT MARCH 31, 2009 |
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90,135 |
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$ |
171,567 |
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$ |
2,731 |
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$ |
2,409 |
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$ |
(122,596 |
) |
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$ |
54,111 |
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Warrants to |
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acquire |
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Warrants |
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Common Stock |
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Common |
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to be |
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Accumulated |
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Three Months Ended March 31, 2008 |
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Shares |
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Amount |
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Stock |
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Issued |
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Deficit |
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Total |
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BALANCES AT DECEMBER 31, 2007 |
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88,901 |
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$ |
165,829 |
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$ |
2,795 |
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$ |
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$ |
(103,966 |
) |
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$ |
64,658 |
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Net loss |
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(5,544 |
) |
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(5,544 |
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Exercise of warrants into common stock |
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50 |
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101 |
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(64 |
) |
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37 |
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Exercise of stock options |
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163 |
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422 |
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422 |
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Employee stock purchase plan issuances |
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8 |
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58 |
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58 |
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Amortization of deferred compensation
related to
restricted stock awards |
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10 |
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225 |
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225 |
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Stock-based compensation expense |
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464 |
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464 |
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BALANCES AT MARCH 31, 2008 |
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89,132 |
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$ |
167,099 |
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$ |
2,731 |
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$ |
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$ |
(109,510 |
) |
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$ |
60,320 |
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5
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS (UNAUDITED)
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THREE MONTHS |
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ENDED MARCH 31 |
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2009 |
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2008 |
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OPERATING ACTIVITIES |
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Net loss |
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$ |
(10,691 |
) |
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$ |
(5,544 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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1,545 |
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1,118 |
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Amortization of deferred financing fees |
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1,454 |
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Non-cash stock compensation expense |
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955 |
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|
689 |
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Non-cash supply agreement termination expense |
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1,051 |
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Changes in operating assets and liabilities: |
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Trade accounts receivable |
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(6,148 |
) |
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1,041 |
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Inventories |
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497 |
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(2,700 |
) |
Prepaid expenses and other current assets |
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764 |
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233 |
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Other long-term assets |
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1,246 |
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Supply agreement termination liabilities |
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4,750 |
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Trade accounts payable |
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3,993 |
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(5,726 |
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Accrued expenses and other liabilities |
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298 |
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284 |
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NET CASH USED IN OPERATING ACTIVITIES |
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(1,532 |
) |
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(9,359 |
) |
INVESTING ACTIVITIES |
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Purchases of property, plant and equipment |
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(301 |
) |
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(269 |
) |
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NET CASH USED IN INVESTING ACTIVITIES |
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(301 |
) |
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|
(269 |
) |
FINANCING ACTIVITIES |
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Repayment of long-term debt |
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(103 |
) |
Restricted cash for revolving credit agreement |
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(2,050 |
) |
Loan origination fees revolving line of credit |
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(1,274 |
) |
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Proceeds from line of credit |
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5,509 |
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6,743 |
|
Proceeds from exercise of stock warrants |
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37 |
|
Proceeds under stock option and stock purchase plans |
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1,216 |
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|
480 |
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NET CASH PROVIDED BY FINANCING ACTIVITIES |
|
|
5,451 |
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|
5,107 |
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INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
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3,618 |
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(4,521 |
) |
Cash and cash equivalents at beginning of period |
|
|
1,063 |
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|
7,948 |
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CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
$ |
4,681 |
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$ |
3,427 |
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SUPPLEMENTAL DISCLOSURES |
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Amount paid for interest |
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$ |
79 |
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$ |
175 |
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Amount paid for income taxes |
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$ |
3 |
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$ |
3 |
|
See notes to condensed consolidated financial statements
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 or Akorn), manufacture and market diagnostic and therapeutic pharmaceuticals in
specialty areas such as ophthalmology, rheumatology, anesthesia, antidotes and vaccines, 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. 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 for interim financial
information and accordingly do not include all the information and footnotes required by accounting
principles generally accepted in the United States for complete financial statements. In
the opinion of management, all adjustments of a normal and recurring nature considered necessary
for a fair presentation have been included in these financial statements. Operating results for the
three-month period ended March 31, 2009 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, 2008, included in the Companys Annual Report on Form
10-K.
The accompanying financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. The Company has incurred recurring net losses and its borrowings on its revolving credit
facility have been restricted by its lender.
The Companys lack of liquidity, limited capital resources, and accumulated debt raise substantial doubt as to its
ability to continue as a going concern. Managements plans in regard to these matters are described below.
The accompanying consolidated financial statements do not include any adjustments to reflect the possible future effect on
the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome
of this uncertainty.
The Companys continuation is dependent
upon its ability to generate or obtain sufficient cash to meet its obligations on a timely basis. On March 31, 2009,
the Company consented to an Assignment Agreement (Assignment) between GE Capital and EJ Funds LP (EJ Funds)
which transferred
to EJ Funds all of GE Capitals rights and obligations under the Credit Agreement.
Pursuant to the Assignment, EJ Funds became the agent and lender under the Credit Agreement (see Note H below).
Accordingly, GE is no longer the Companys lender. Dr. Kapoor is the President of EJ Financial Enterprises, Inc.,
a healthcare consulting investment company (EJ Financial) and EJ Financial is the general partner of EJ Funds.
Dr. Kapoor is the Companys Chairman of the Board of Directors and the holder of a significant stock position in the Company.
Based on the Companys operating plan,
its existing working capital is not sufficient to meet the cash requirements to fund its planned operating expenses, capital
expenditures, and working capital requirements without additional sources of cash and/or the deferral, reduction or elimination
of significant planned expenditures.
The Company is evaluating alternatives for cost reduction as well as certain efficiency and cost containment
measures to improve its profitability and cash flow. Currently, the Company has no commitments to obtain additional capital,
and there can be no assurance that financing will be available in amounts or on terms acceptable to the Company, if at all.
NOTE B SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates: The preparation of financial statements in conformity with accounting
principles generally accepted in the United States 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 allowance for
product returns and discounts, the reserve for slow-moving and obsolete inventories, the carrying
value of intangible assets and the carrying value of deferred income tax assets.
Chargebacks: The Company enters into contractual agreements with certain third parties such as
hospitals and group-purchasing organizations to sell certain products at predetermined prices. The
parties have elected to have these contracts administered through wholesalers that buy the product
from the Company and subsequently sell it to these third parties. When a wholesaler sells products
to one of these third parties that are subject to a contractual price agreement, the difference
between the price paid to the Company by the wholesaler and the price under the specific contract
is charged back to the Company by the wholesaler. The Company tracks sales and submitted
chargebacks by product number and contract for each wholesaler. Utilizing this information, the
Company estimates a chargeback percentage for each product. The Company reduces gross sales and
increases the chargeback allowance by the estimated chargeback amount for each product sold to a
wholesaler. The Company reduces the chargeback allowance when it processes a request for a
chargeback from a wholesaler. Actual chargebacks processed by the Company can vary materially from
period to period based upon actual sales volume through the wholesalers. However, the Companys
expense provision for chargebacks is recorded at the time when sales revenues are recognized.
Management obtains certain wholesaler inventory reports to aid in analyzing the reasonableness
of the chargeback allowance. The Company assesses the reasonableness of its chargeback allowance by
applying the product chargeback percentage based on historical activity to the quantities of
inventory on hand per the wholesaler inventory reports and an estimate of in-transit inventory that
is not reported on the wholesaler inventory reports at the end of the period. In accordance with
its accounting policy, the Companys estimate of the percentage amount of wholesaler inventory that
will ultimately be sold to a third party that is subject to a contractual price agreement is based
on a six-quarter trend of such sales through wholesalers. The Company uses this percentage estimate
(95% in 2009 and 2008) until historical trends indicate that a revision should be made.
7
On an ongoing basis, the Company evaluates its actual chargeback rate experience and new
trends are factored into its estimates each quarter as market conditions change.
Sales Returns: Certain of the Companys products are sold with the customer having the right
to return the product within specified periods and guidelines for a variety of reasons, including
but not limited to, pending expiration dates. Provisions are made at the time of sale based upon
tracked historical experience, by customer in some cases. The Company estimates its sales returns
reserve based on a historical percentage of returns to sales utilizing a twelve month look back
period. One-time historical factors or pending new developments that would impact the expected
level of returns are taken into account to determine the appropriate reserve estimate at each
balance sheet date.
As part of the evaluation of the balance required, the Company considers actual returns to
date that are in process, the expected impact of any product recalls and the wholesalers inventory
information to assess the magnitude of unconsumed product that may result in a sales return to the
Company in the future. The sales returns level can be impacted by factors such as overall market
demand and market competition and availability for substitute products which can increase or
decrease the end-user pull through for sales of the Companys products and ultimately impact the
level of sales returns. Actual returns experience and trends are factored into the Companys
estimates each quarter as market conditions change.
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 three months of 2009 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.
Under SFAS No. 123(R), stock compensation cost is estimated at the grant date based on the fair
value of the award, and the cost is recognized as expense ratably over the vesting period. The
Company uses the Black-Scholes model for estimating the fair value of stock options in providing
the pro forma fair value method disclosures pursuant to SFAS No. 123(R). Determining the
assumptions that enter into the model is highly subjective and requires judgment. The Company uses
an expected volatility that is based on the historical volatility of its stock. The expected life
assumption is based on historical employee exercise patterns and employee post-vesting termination
behavior. The risk-free interest rate for the expected term of the option is based on the average
market rate on U.S. treasury securities in effect during the quarter in which the options were
granted. The dividend yield reflects historical experience as well as future expectations over the
expected term of the option. Also, under SFAS No. 123(R), the Company is required to estimate
forfeitures at the time of grant and revise in subsequent periods, if necessary, if actual
forfeitures differ from those estimates. After reviewing historical forfeiture information, the
Company decided to revise its estimate from 10% used in the quarter
ended March, 31, 2008 to 13% as an estimated
forfeiture rate for 2009.
Stock option compensation expense of $795,000 was recognized during the first quarter of 2009, of
which $293,000 relates to the accelerated vesting of the Companys former CEOs stock options. 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.
8
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, 2009 |
|
MARCH 31, 2008 |
|
|
|
Expected volatility |
|
|
78 |
% |
|
|
44 |
% |
Expected life (in years) |
|
|
4.0 |
|
|
|
4.0 |
|
Risk-free interest rate |
|
|
1.8 |
% |
|
|
2.8 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
Fair value per stock option |
|
$ |
1.12 |
|
|
$ |
2.62 |
|
Forfeiture rate |
|
|
13 |
% |
|
|
10 |
% |
A summary of stock-based compensation activity within the Companys stock-based compensation plans
for the three-month period ended March 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average |
|
|
|
|
Number of |
|
Weighted |
|
Remaining |
|
Aggregate |
|
|
Shares |
|
Average |
|
Contractual Term |
|
Intrinsic Value |
|
|
(in thousands) |
|
Exercise Price |
|
(Years) |
|
(in thousands) |
|
Outstanding
at December 31, 2008 |
|
|
3,684 |
|
|
$ |
5.20 |
|
|
|
2.56 |
|
|
$ |
43,500 |
|
Granted |
|
|
80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2009 |
|
|
3,742 |
|
|
$ |
5.15 |
|
|
|
1.88 |
|
|
$ |
0 |
|
|
Exercisable at March 31, 2009 |
|
|
2,865 |
|
|
$ |
5.16 |
|
|
|
1.40 |
|
|
$ |
0 |
|
|
The aggregate intrinsic value for stock options outstanding and exercisable is defined as the
difference between the market value of the Companys common stock as of the end of the period and
the exercise price of the stock options. No stock options were exercised during the first quarter
of 2009.
The Company also grants restricted stock awards to certain employees and members of its Board of
Directors. 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 granted restricted stock
awards valued at $120,000 during the first quarter of 2009. As of March 31, 2009, the total amount
of unrecognized compensation expense related to nonvested restricted stock awards was $171,000.
The Company recognized compensation expense of $160,000 during the first quarter of 2009 related to
outstanding restricted stock awards, of which $26,000 relates to the accelerated vesting of the
Companys former CEOs restricted stock awards.
The following is a summary of nonvested restricted stock activity:
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted Average |
|
|
(in thousands) |
|
Grant Date Fair Value |
|
Nonvested at December 31, 2008 |
|
|
125 |
|
|
$ |
5.74 |
|
Granted |
|
|
55 |
|
|
|
2.19 |
|
Vested |
|
|
(130 |
) |
|
|
4.06 |
|
|
Nonvested at March 31, 2009 |
|
|
50 |
|
|
|
6.20 |
|
|
NOTE D REVENUE RECOGNITION
The Company recognizes product sales for its ophthalmic, hospital drugs & injectables, and
biologics & vaccines business segments upon the shipment of goods or upon the delivery of goods as
appropriate. Revenue is recognized when all obligations of the Company have been fulfilled and
collection of the related receivable is probable.
9
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
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 final net collections 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.
The provisions for the following customer reserves are reflected in the accompanying financial
statements as reductions of revenues in the statements of operations 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 trade accounts receivable in the balance sheet.
Net trade accounts receivable consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Gross accounts receivable |
|
$ |
23,753 |
|
|
$ |
18,723 |
|
Less: |
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
|
(29 |
) |
|
|
(22 |
) |
Returns reserve |
|
|
(1,939 |
) |
|
|
(2,539 |
) |
Discount and allowances reserve |
|
|
(465 |
) |
|
|
(322 |
) |
Chargeback and rebates reserves |
|
|
(8,643 |
) |
|
|
(9,311 |
) |
|
|
|
|
|
|
|
Net trade accounts receivable |
|
$ |
12,677 |
|
|
$ |
6,529 |
|
|
|
|
|
|
|
|
For the three-month periods ended March 31, 2009 and 2008, the Company recorded chargeback and
rebate expense of $7,590,000 and $8,310,000, respectively. This decrease was primarily due to a
favorable sales mix of lower chargeback products in 2009.
For the three-month periods ended March 31, 2009 and 2008, the Company recorded a provision
for product returns of $532,000 and $114,000 respectively. The increase in the provision was due
to increased sales and less favorable wholesaler returns experience.
For the three-month period ended March 31, 2009, the Company recorded a net provision for
doubtful accounts of $7,000. For the three-month period ended March 31, 2008, the Company recorded
a net benefit for doubtful accounts of $2,000.
For the three-month periods ended March 31, 2009 and 2008, the Company recorded a provision
for cash discounts of $509,000 and $391,000, respectively. These increases primarily relate to the
increases in sales for the quarter.
10
NOTE F INVENTORIES
The components of inventories are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Finished goods |
|
$ |
19,887 |
|
|
$ |
21,000 |
|
Work in process |
|
|
1,960 |
|
|
|
1,802 |
|
Raw materials and supplies |
|
|
7,819 |
|
|
|
7,361 |
|
|
|
|
|
|
|
|
|
|
$ |
29,666 |
|
|
$ |
30,163 |
|
|
|
|
|
|
|
|
The Company maintains reserves and records provisions for slow-moving and obsolete inventory
as well as inventory with a carrying value in excess of its net realizable value. Inventory at
March 31, 2009 and December 31, 2008 is reported net of these reserves of $1,106,000 and
$1,179,000, respectively, primarily related to finished goods. At March 31, 2009, the Company had
$864,000 in its ending inventory for raw material related to its generic oral Vancomycin capsule
product. The Company has not yet received approval from the FDA to market its oral Vancomycin product.
NOTE G PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
MARCH 31, |
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Land |
|
$ |
396 |
|
|
$ |
396 |
|
Buildings and leasehold improvements |
|
|
19,741 |
|
|
|
19,607 |
|
Furniture and equipment |
|
|
46,612 |
|
|
|
46,297 |
|
|
|
|
|
|
|
|
Sub-total |
|
|
66,749 |
|
|
|
66,300 |
|
Accumulated depreciation |
|
|
(33,680 |
) |
|
|
(32,710 |
) |
|
|
|
|
|
|
|
|
|
|
33,069 |
|
|
|
33,590 |
|
|
|
|
|
|
|
|
|
|
Construction in progress |
|
|
485 |
|
|
|
633 |
|
|
|
|
|
|
|
|
Property,
plant and equipment, net |
|
$ |
33,554 |
|
|
$ |
34,223 |
|
|
|
|
|
|
|
|
NOTE H FINANCING ARRANGEMENTS
Subordinated Note Payable
On July 28, 2008, the Company borrowed $5,000,000 from The John N. Kapoor Trust dated
September 20, 1989 (the Kapoor Trust), the sole trustee and sole beneficiary of which is Dr. John
N. Kapoor, the Companys Chairman of the Board of Directors and the holder of a significant stock
position in the Company, in return for issuing the trust a Subordinated Promissory Note
(Subordinated Note). The note accrues interest at a rate of 15% per year and is due and payable
on July 28, 2009. The proceeds from this note were used in conjunction with the amended MBL
Distribution Agreement that was negotiated with the Massachusetts Biologic Laboratories of the
University of Massachusetts Medical School (MBL) (see also Note L Commitments and Contingencies).
Credit Facility
On January 7, 2009, the Company entered into a Credit Agreement (the Credit Agreement) with
General Electric Capital Corporation (GE Capital) as agent for several financial institutions
(the Lenders) to replace its previous credit agreement with Bank of America which expired on
January 1, 2009. Pursuant to the Credit Agreement, the Lenders agreed, among other things, to
extend loans to the Company under a revolving credit facility (including a letter of credit
subfacility) up to an aggregate principal amount of $25,000,000 (the Credit Facility). At the
Companys election, borrowings under the Credit Facility bore interest at a rate equal to either:
(i) the Base Rate (defined as the highest of the Wall Street Journal prime rate, the federal funds
rate plus 0.5% or LIBOR plus 1.0%), plus a margin equal to (x) 4% for the period commencing on the
closing date through April 14, 2009, or (y) a percentage that ranged between 3.75% and 4.25% for
the period after April 14, 2009, or (ii) LIBOR (or 2.75%, if LIBOR is less than 2.75%), plus a
margin equal to (x) 5% for the period commencing on the closing date through April 14, 2009, or
(y) a percentage that ranged between
11
4.75% and 5.25% for the period after April 14, 2009. Upon the
occurrence of any event of default, the Company was to pay interest equal
to an additional 2.0% per year. The Credit Agreement contained affirmative, negative and
financial covenants customary for financings of this type. The negative covenants included
restrictions on liens, indebtedness, payments of dividends, disposition of assets, fundamental
changes, loans and investments, transactions with affiliates and negative pledges. The financial
covenants included fixed charge coverage ratio, minimum-EBITDA, minimum liquidity and a maximum
level of capital expenditures. In addition, the Companys obligations under the Credit Agreement
could have been accelerated upon the occurrence of an event of default under the Credit Agreement,
which included customary events of default such as payment defaults, defaults in the performance of
affirmative and negative covenants, the inaccuracy of representations or warranties, bankruptcy and
insolvency related defaults, defaults relating to judgments, defaults relating to certain
governmental enforcement actions, and a change of control default.
Also on January 7, 2009, in connection with the Credit Agreement, the Company entered
into a Guaranty and Security Agreement (the Guaranty and Security Agreement) with GE Capital, as
agent for the Lenders and each other secured party thereunder. Pursuant to the Guaranty and
Security Agreement, the Company granted a security interest to GE Capital in the collateral
described in the Guaranty and Security Agreement as security for the Credit Facility. The Companys
obligations were secured by substantially all of its assets, excluding its ownership interest in
Akorn-Strides, LLC and in certain licenses and other property in which assignments are prohibited
by confidential provisions.
In connection with the Credit Agreement, on January 7, 2009, the Company also entered
into a Mortgage, Security Agreement, Assignment of Leases and Rents, Financing Statement and
Fixture Filing by the Company, in favor of GE Capital, relating to the real property owned by the
Company located in Decatur, IL. The Mortgages granted a security interest in the two parcels of
real property to GE Capital, as security for the Credit Facility.
Also on January 7, 2009, in connection with the Credit Agreement, the Company entered
into a Subordination Agreement with the Kapoor Trust and GE Capital, as agent for the Lenders.
Pursuant to the Subordination Agreement, the Kapoor Trust and the Company agreed that the
Subordinated Note payable to the Kapoor Trust was subordinated to the Credit Facility, except that
so long as there was no event of default outstanding under the Credit Agreement, the Company could
repay that debt in full if the repayment occurred by July 28, 2009.
On February 19, 2009, GE Capital informed the Company that it was applying a reserve against
availability which effectively restricted the Companys borrowings under the Credit Agreement to
the balance outstanding as of February 19, 2009, which was $5,523,620. GE Capital advised that it
had applied this reserve due to concerns about financial performance, including the Companys
prospective compliance with certain covenants in the Credit Agreement for the quarter ended
March 31, 2009.
On March 31, 2009, the Company consented to an Assignment Agreement (Assignment) between GE
Capital and EJ Funds LP (EJ Funds) which transferred to EJ Funds all of GE Capitals rights and
obligations under the Credit Agreement. Pursuant to the Assignment, EJ Funds became the agent and
lender under the Credit Agreement. Accordingly, GE is no longer the Companys lender. Dr. Kapoor
is the President of EJ Financial Enterprises, Inc., a healthcare consulting investment company (EJ
Financial) and EJ Financial is the general partner of EJ Funds.
In connection with the Assignment, on April 13, 2009, the Company entered into a Modification,
Warrant and Investor Rights Agreement (the Modification Agreement) with EJ Funds that, among
other things, (i) reduced the revolving loan commitment under the Credit Agreement to $5,650,000,
(ii) provided an extended cure period until July 22, 2009 for any event, other than specified types
of Material Defaults listed in the Modification Agreement, which could constitute an Event of
Default under the Credit Agreement, unless that period is terminated earlier due to the occurrence
of a Material Default or as otherwise provided in the Modification Agreement, (iii) set the
interest rate for all amounts outstanding under the Credit Agreement at an annual rate of 10% with
interest payable monthly, (iv) granted a security interest in and lien upon all the collateral
under the Credit Agreement to the Kapoor Trust as security for the Subordinated Note, and (v)
requires the Company, within 30 days after the date of the Modification Agreement, to enter into
security documents consisting of a security agreement and mortgages (if requested by the Kapoor
Trust) in form and substance substantially similar to the corresponding security documents under
the Credit Agreement for the Kapoor Trusts interest in connection with the Subordinated Note. The
Modification Agreement also granted EJ Funds the right to require the Company to nominate two
directors to serve on its Board of Directors. The Kapoor Trust is entitled to require the Company
to nominate a third director under its Stock Purchase Agreement dated November 15, 1990 with the
Kapoor Trust. In addition, the Company agreed to pay all accrued legal fees and other expenses of
EJ Funds that relate to the Credit Agreement and other loan documents, including legal expenses
incurred with respect to the Modification Agreement and the Assignment.
12
Pursuant to the Modification Agreement, on April 13, 2009 the Company granted EJ Funds a
warrant (the Modification Warrant) to purchase 1,939,639 shares of its common stock at an
exercise price of $1.11 per share, subject to certain adjustments. The Modification Warrant expires
five years after its issuance and is exercisable upon payment of the exercise price in cash or by
means of a cashless exercise yielding a net share figure. Under the Modification Agreement, the
Company has the right to convert the Subordinated Note into term indebtedness under the Credit
Agreement in exchange for additional warrants, on terms substantially identical to the Modification
Warrant, to purchase 343,299 shares of its common stock for each $1,000,000 of converted debt. The
exercise price of those warrants would also be $1.11 per share. The estimated fair value of the
Modification Warrant, using a Black-Scholes valuation model, is
$1,357,747. This amount was capitalized as deferred financing costs
and is included in other long term assets in the accompanying balance
sheet.
In 2008, the Company capitalized $272,000 of loan origination fees and costs in association
with the Credit Facility. In 2009, the Company incurred closing costs and additional legal fees
related to the Credit Facility of $1,182,000. Upon the assignment of the Credit Facility to EJ
Funds, the Company expensed the total deferred financing costs of $1,454,000. In 2009, the Company
capitalized $1,358,000 for the fair value of the Modification Warrant and $92,000 for other costs
in association with the assignment of the Credit Facility.
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. All 1,509,088 warrants remained outstanding as of March 31, 2009.
The total 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 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 loss per common share is based upon weighted average common shares outstanding.
Diluted net loss per common share is based upon the weighted average number of common shares
outstanding, including the dilutive effect, if any, of stock options and warrants using the
treasury stock method. However, for the three-month periods ended March 31, 2009 and 2008, the
assumed exercise 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.
The
number of such shares as of March 31, 2009 and March 31,
2008 subject to warrants was 5,406,000 and
1,965,000, respectively. The number of such shares as of March 31, 2009 and March 31, 2008 subject to stock
options was 3,741,000 and 4,448,000, respectively.
NOTE K INDUSTRY SEGMENT INFORMATION
The Company classifies its operations into four business segments: ophthalmic, hospital drugs
& injectables, biologics & vaccines, and contract services. The ophthalmic segment manufactures,
markets and distributes diagnostic and therapeutic pharmaceuticals. The hospital drugs &
injectables segment manufactures, markets and distributes drugs and injectable pharmaceuticals,
primarily in niche markets. The biologics & vaccines segment markets adult Tetanus Diphtheria
(Td) and Flu vaccines directly to hospitals and physicians as well as through wholesalers and
national distributors. The contract services segment manufactures products for third party
pharmaceutical and biotechnology customers based on their specifications. The Companys basis of
accounting in preparing its segment information is consistent with that used in preparing its
consolidated financial statements.
13
Selected financial information by industry segment is presented below (in thousands).
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED MARCH 31, |
|
|
|
2009 |
|
|
2008 |
|
REVENUES |
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
5,080 |
|
|
$ |
5,953 |
|
Hospital Drugs & Injectables |
|
|
4,528 |
|
|
|
5,082 |
|
Biologics & Vaccines |
|
|
10,698 |
|
|
|
1,817 |
|
Contract Services |
|
|
1,734 |
|
|
|
1,607 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
22,040 |
|
|
$ |
14,459 |
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
1,008 |
|
|
$ |
1,842 |
|
Hospital Drugs & Injectables |
|
|
884 |
|
|
|
1,101 |
|
Biologics & Vaccines |
|
|
3,371 |
|
|
|
368 |
|
Contract Services |
|
|
99 |
|
|
|
436 |
|
|
|
|
|
|
|
|
Total gross profit |
|
|
5,362 |
|
|
|
3,747 |
|
Operating expenses |
|
|
14,379 |
|
|
|
8,972 |
|
|
|
|
|
|
|
|
Operating loss |
|
|
(9,017 |
) |
|
|
(5,225 |
) |
Interest and other income (expense) |
|
|
(218 |
) |
|
|
(316 |
) |
Write off of
deferred financing costs |
|
|
(1,454 |
) |
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
$ |
(10,689 |
) |
|
$ |
(5,541 |
) |
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
(i) The Company has an outstanding product warranty reserve which relates to a ten-year
expiration guarantee on DTPA sold to HHS in 2006. The Company is performing yearly stability
studies for this product and, if the annual stability does not support the ten-year product life,
it will replace the product at no charge. The Companys supplier, Hameln Pharmaceuticals, will also
share one-half of this cost if the product does not meet the stability requirement. If the ongoing
product testing confirms the ten-year stability for DTPA, the Company will not incur a replacement
cost and this reserve will be eliminated with a corresponding reduction to cost of sales after the
ten-year period.
(ii) In July 2008, the Company and MBL amended their Exclusive Distribution Agreement dated as
of March 22, 2007 (the MBL Distribution Agreement) to: (i) allow the Company to destroy its
remaining inventory of Td vaccine, 15 dose/vial, in exchange for receiving an equivalent number of
doses of preservative-free Td vaccine, 1 dose/vial (the Single-dose Product) at no additional
cost other than destruction and documentation expenses; (ii) reduce the purchase price of the
Single-dose Product during the first year of the MBL Distribution Agreement by approximately 14.4%;
(iii) reduce the Companys purchase commitment for the second year by approximately 34.7%; and (iv)
reduce the Companys purchase commitment for the third year by approximately 39.5%.
The Company was subsequently unable to make a payment of approximately $3,375,000 for Td
vaccine products which was due to MBL by February 27, 2009 under its MBL Distribution Agreement.
While the Company made a partial payment of $1,000,000 to MBL on March 13, 2009, it would have also
been unable to make another payment of approximately $3,375,000 due to MBL on March 28, 2009.
Accordingly, the Company entered into a letter agreement with MBL on March 27, 2009 (MBL Letter
Agreement), pursuant to which it agreed to pay MBL the $5,750,000 remaining due for these Td
vaccine products plus an additional $4,750,000 in consideration of the amendments to the MBL
Distribution Agreement payable according to a periodic payment schedule through June 30, 2010 (the
Settlement Payments). In addition, pursuant to the MBL Letter Agreement, the MBL Distribution
Agreement was converted to a non-exclusive agreement, the Company became obligated to provide MBL
with a standby letter of credit by April 12, 2009 to secure its obligation to pay amounts due to
MBL (the L/C), and the Company was released from its obligation to further purchase Td vaccine
products from MBL upon providing MBL with such L/C. In addition, pursuant to the MBL Letter
Agreement, MBL agreed not to declare a breach or otherwise act to terminate the MBL Distribution
Agreement, if the Company complied with the terms of the MBL
14
Letter Agreement, the MBL Distribution Agreement (as amended by the MBL Letter Agreement) and
any agreements required to be entered into pursuant to the MBL Letter Agreement.
On April 15, 2009, the Company entered into a Settlement Agreement with MBL (the MBL
Settlement Agreement) to elaborate the MBL Letter Agreement. The MBL Settlement Agreement provides
that the Company will pay MBL the Settlement Payments according to a monthly payment schedule
through June 30, 2010. The MBL Settlement Agreement provides that MBL may only draw on the L/C if:
(i) the Company fails to make any Settlement Payment when due, (ii) any Settlement Payment made is
set aside or otherwise required to be repaid by MBL, or (iii) the Company becomes the debtor in a
bankruptcy or other insolvency proceeding begun before October 6, 2010 and no replacement letter of
credit has been issued prior to the expiration of the L/C.
Also on April 15, 2009, the Company entered into an amendment to the MBL Distribution
Agreement with MBL (the MBL Amendment). The MBL Amendment modified the MBL Distribution Agreement
to, among other things, eliminate the Companys future minimum purchase requirements under the MBL
Distribution Agreement.
On April 15, 2009, the Company entered into a Reimbursement and Warrant Agreement (the
Reimbursement Agreement) with EJ Funds and the Kapoor Trust, pursuant to which the Kapoor Trust
agreed to provide the L/C as security for the Companys payment obligations to MBL under the MBL
Letter Agreement and the MBL Settlement Agreement. Simultaneous with the delivery of the
Reimbursement Agreement, the L/C was issued by the Bank of America in favor of MBL. The
Reimbursement Agreement provides, among other things, that the Company will reimburse the Kapoor
Trust for any draws by MBL under the L/C through the mechanism of causing the amount of the draws
to become term indebtedness payable to the Kapoor Trust on the same terms as the revolving debt
under the Credit Agreement. All of the Companys obligations under the Reimbursement Agreement will
also be considered secured obligations under the Credit Agreement. Pursuant to the Reimbursement
Agreement, the Company also issued a warrant to the Kapoor Trust (the Reimbursement Warrant) to
purchase 1,501,933 shares of its common stock at an exercise price of $1.11 per share, subject to
certain adjustments. The Reimbursement Warrant expires five years from the date of issuance and is
exercisable upon payment of the exercise price in cash or by means of a cashless exercise yielding
a net share figure. In addition, the Reimbursement Agreement provides that the Company must issue
the Kapoor Trust additional warrants, at that same price of $1.11 per share, to purchase 200,258
shares of its common stock per $1,000,000 drawn on the L/C. The estimated fair value of the
Reimbursement Warrant, using a Black-Scholes valuation model, is
$1,051,353. This amount is recorded in supply agreement termination
expenses in the accompanying statement of operations.
The shares of the Companys common stock issuable upon exercise of the Modification Warrant
and the Reimbursement Warrant, along with those other warrants that may be issued under the
Modification Agreement and Reimbursement Agreement and other shares of common stock held by EJ
Funds, the Kapoor Trust and their affiliates, are subject to registration rights as set forth in
the Modification Agreement. Under the Modification Agreement, the Company agreed to file a
registration statement with the SEC within 75 days of the date of the Modification Agreement. The
Company also agreed to continue the effectiveness of the registration statement until the earliest
of the dates (i) all securities registrable thereunder have been sold, (ii) all such registrable
securities may be sold in a single transaction by their holders to the public under Rule 144 under
the Securities Act of 1933, and (iii) no shares of the Companys common stock registered under the
registration statement qualify as registrable securities thereunder.
(iii) On January 29, 2009, Arthur S. Przybyl was notified he would no longer be the President
and Chief Executive Officer of the Company. Mr. Przybyls Executive Employment Agreement dated
April 24, 2006, which was filed with the SEC as Exhibit 10.1 to Akorn, Inc.s Current Report on
Form 8-K filed April 28, 2006, required the Company to pay severance under certain circumstances
specified in the Executive Employment Agreement. The Company has advised Mr. Przybyl that it does
not believe those circumstances occurred. Mr. Przybyl has demanded an arbitration to resolve these
issues. Accordingly, the Company does not yet know whether it will ultimately pay Mr. Przybyl any
severance or, if so, how much will be paid. The Company has also asserted claims against Mr.
Przybyl.
(iv) The Company is a party in other 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
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
15
customers accounted for 67% and 69% of the Companys gross revenues and 57% and 52% of net
revenues for the three months ended March 31, 2009 and 2008, respectively. They accounted for
approximately 65% and 73% of the gross accounts receivable balance as of March 31, 2009 and 2008,
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, 2009, MBL (Td vaccine) accounted for 71% of the Companys
purchases. For the three months ended March 31, 2008, MBL (Td vaccine) and Draxis Pharma (supplier
for IC Green) accounted for 77% and 11%, respectively, 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 ANDAs and New Drug
Applications, 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.
NOTE N RECENT ACCOUNTING PRONOUNCEMENTS
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value, and expands disclosures
about fair value measurements. SFAS 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. In February of 2008, the FASB issued FASB Staff position
157-2 which delays the effective date of SFAS 157 for non-financial assets and liabilities which
are not measured at fair value on a recurring basis (at least annually) until fiscal years
beginning after November 15, 2008. The Company adopted SFAS 157 effective January 1, 2008 and the
adoption did not have a material impact on the Companys results of operation or financial
position.
In December 2007, the FASB issued SFAS No. 160, Non-Controlling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS 160). SFAS 160 establishes new standards
for the accounting for and reporting of non-controlling interests (formerly minority interests) and
for the loss of control of partially owned and consolidated subsidiaries. SFAS 160 does not change
the criteria for consolidating a partially owned entity. SFAS 160 is effective for fiscal years
beginning after December 15, 2008. The Company adopted SFAS 160
effective January 1, 2009 and the adoption did not have a material
impact on its consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141 (revised 2007) (SFAS 141R), a revision of
SFAS 141, Business Combinations. SFAS 141R establishes requirements for the recognition and
measurement of acquired assets, liabilities, goodwill, and non-controlling interests. SFAS 141R
also provides disclosure requirements related to business combinations. SFAS 141R is effective for
fiscal years beginning after December 15, 2008. SFAS 141R will be applied prospectively to
business combinations with an acquisition date on or after the effective date.
In April 2008, the FASB issued FSP SFAS No. 142-3, Determination of the Useful Life of
Intangible Assets. The FSP amends the factors that should be considered in developing renewal or
extension assumptions used to determine the useful life of a recognized intangible asset under SFAS
No. 142, Goodwill and Other Intangible Assets. The intent of the FSP is to improve the consistency
between the useful life of a recognized intangible asset under SFAS No. 142 and the period of
expected cash flows used to measure the fair value of the asset under SFAS No. 141 (revised 2007),
Business Combinations, and other U.S. GAAP. The FSP is effective for financial statements issued
for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years.
The Company adopted FSP SFAS No. 142-3 effective January 1, 2009 and
the adoption did not have a material impact on its consolidated
financial statements.
16
NOTE O UNCONSOLIDATED JOINT VENTURE
The Joint Venture Company launched its first commercialized product in the third quarter of
2008. The Joint Venture Company purchases product from Strides while the Company assists with the
sales and product distribution/fulfillment functions. The Company and Strides each own a 50%
interest in the Joint Venture Company.
Operating results of the Joint Venture Company for the three months ended March 31, 2009
included revenue of $868,000, gross profit of $559,000 and net income of $120,000. The Companys
50% share of the Joint Venture Company net income, $60,000, is reflected as part of other income on
the Companys statement of operations and statement of cash flows.
17
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 U.S. Food and Drug
Administration (FDA), including current Good Manufacturing Practices regulations; |
|
|
|
|
Our ability to avoid defaults under debt covenants; |
|
|
|
|
Our ability to obtain regulatory approvals for products manufactured in our new
lyophilization
facility; |
|
|
|
|
Our ability to generate cash from operations sufficient to meet our working capital
requirements; |
|
|
|
|
Our ability to obtain additional funding or financing to operate and grow our business; |
|
|
|
|
The effects of federal, state and other governmental regulation on our business; |
|
|
|
|
Our success in developing, manufacturing, acquiring and marketing new products; |
|
|
|
|
Our success in gaining additional market share for our Td
vaccine purchased by hospitals and physicians through our key
wholesalers, distributors and direct sales channels; |
|
|
|
|
Our ability to make timely payments to our Td vaccine supplier; |
|
|
|
|
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
As a result of our lack of liquidity,
limited capital resources, continued operating losses and accumulated debt, we have concluded there is substantial doubt as to our
ability to continue as a going concern -
see Financial Condition and Liquidity discussed below.
THREE MONTHS ENDED MARCH 31, 2009 COMPARED TO THREE MONTHS ENDED MARCH 31, 2008
The following table sets forth, for the periods indicated, revenues by segment, excluding
intersegment sales (in thousands):
18
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
|
|
MARCH 31, |
|
|
|
2009 |
|
|
2008 |
|
Ophthalmic segment |
|
$ |
5,080 |
|
|
$ |
5,953 |
|
Hospital Drugs & Injectables segment |
|
|
4,528 |
|
|
|
5,082 |
|
Biologics & Vaccines segment |
|
|
10,698 |
|
|
|
1,817 |
|
Contract Services segment |
|
|
1,734 |
|
|
|
1,607 |
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
22,040 |
|
|
$ |
14,459 |
|
|
|
|
|
|
|
|
Consolidated revenues increased $7,581,000 or 52.4% in the quarter ended March 31, 2009
compared to the same period in 2008 mainly due to increased sales of Td vaccine.
Vaccine sales increased by $8,881,000 primarily due to an increase in sales of our Td vaccine
products as we increased our market share for Td vaccines. Ophthalmic segment revenues decreased 14.7%, or $873,000, primarily due to a $469,000
floor stock price adjustment for AktenTM and generally lower market demand. Hospital drugs
and injectables segment revenues decreased 10.9% or $554,000 for the year, reflecting the decreased
sales of anesthesia and antidote products. Contract services revenues increased by 7.9%, or
$127,000, mainly due to increased order volumes on ophthalmic contract products.
Consolidated gross profit was $5,362,000 or 24.3% for the first quarter of 2009 as compared to
a gross profit of $3,747,000 or 25.9% 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 efficiencies and cost reductions at
our operating facilities.
Selling, general and administrative (SG&A) expenses increased by $740,000 or 11.8%, during
the quarter ended March 31, 2009 as compared to the same period in 2008. The key components of this
increase in 2009 were $140,000 in increased legal fees, $240,000 due to increased building rental
expense, and $331,000 in additional SFAS 123(R) stock option compensation expense related primarily
to the accelerated vesting of our former CEOs unvested stock options.
In the first quarter of 2009, we recognized $5,830,000 in expense related to the settlement
of our supply agreement with the Massachusetts Biologic Laboratories
of the University of Massachusetts Medical School (MBL) which consisted of $4,750,000 in settlement payments, $1,051,000
in costs for warrants associated with a letter of credit guarantee for the $10,500,000 in total payments due
MBL, and $29,000 in other related costs (see Contractual Obligations below).
Research and development (R&D) expense decreased $1,399,000 or 58.9% in the quarter, to
$977,000 from $2,376,000 for the same period in 2008. The first quarter 2008 R&D expense reflects
a write-off of certain product related filing and license fees totaling $1,246,000.
Net interest expense for the first quarter of 2009 was $278,000 versus net interest expense of
$115,000 for the same period in 2008. This increase is primarily due to the interest payable on
our subordinated note which commenced in the third quarter of 2008.
For the three-month period ended March 31, 2009, the income tax provision was $2,000 versus
income tax provision of $3,000 during the same period in 2008. This relates to minimum state
income tax assessments.
We reported a net loss of $10,691,000 for the three months ended March 31, 2009, versus a net
loss of $5,544,000 for the same period in 2008 mainly due to higher
SG&A and net interest expense, along with the 2009 expenses
associated with the termination of our supply agreement with MBL,
partially offset by increased sales volume and gross profit, along
with lower R&D expense as discussed above.
FINANCIAL CONDITION AND LIQUIDITY
Overview
During
the three-month period ended March 31, 2009, we used $1,532,000 in cash from
operations, primarily due to the $10,691,000 net loss and a $6,148,000 accounts receivable increase
in line with higher sales, partially offset by a $3,993,000 increase in accounts payable and
$4,750,000 in supply agreement termination liabilities associated with our Td vaccine supply
agreement termination. In addition we had $1,454,000 in deferred financing cost write-offs along
with non-cash depreciation, amortization, stock compensation and supply agreement termination
expense totaling $3,551,000.
19
During the three-month period ended March 31, 2008, we used $9,359,000 in cash from
operations, primarily due to the net loss, a $6,868,000 change in working capital items mainly due
to an increase in inventory and reduced accounts payable related to payments for vaccine inventory,
offset by non-cash expenses of $1,807,000 for the period. Investing activities generated a $269,000
reduction in cash flow mainly due to capital expenditures for production equipment. Financing
activities provided $5,107,000 in cash, primarily due to the $6,743,000 in proceeds from our then
existing Credit Facility with Bank of America and $517,000 in proceeds from stock option and
warrant exercises, partially offset by an increase in the restricted cash requirement of
$2,050,000.
As a result of our lack of liquidity,
limited capital resources, continued operating losses and accumulated debt, we have concluded there is substantial doubt as
to our ability to continue as a going concern. These factors may make it more difficult for us to obtain additional funding to meet our
obligations. Our ability to continue as a going concern is dependent upon our ability to generate or obtain sufficient cash to meet our
obligations on a timely basis. Based on our operating plan, our existing working capital is not sufficient to meet the cash requirements
to fund our planned operating expenses, capital expenditures, and working capital requirements without additional sources of cash and/or
the deferral, reduction or elimination of significant planned expenditures. Currently, we have no commitments to obtain additional capital,
and there can be no assurance that financing will be available in amounts or on terms acceptable to us, if at all.
Credit Facility
On January 7, 2009, we entered into a Credit Agreement (Credit Agreement) with General
Electric Capital Corporation (GE Capital) as agent for several financial institutions (the
Lenders) to replace our previous credit agreement with Bank of America which expired on January
1, 2009. Pursuant to the Credit Agreement, the Lenders agreed, among other things, to extend loans
to us under a revolving credit facility (including a letter of credit subfacility) up to an
aggregate principal amount of $25,000,000 (the Credit Facility). At our election, borrowings
under the Credit Facility bore interest at a rate equal to either: (i) the Base Rate (defined as
the highest of the Wall Street Journal prime rate, the federal funds rate plus 0.5% or LIBOR plus
1.0%), plus a margin equal to (x) 4% for the period commencing on the closing date through
April 14, 2009, or (y) a percentage that ranged between 3.75% and 4.25% for the period after
April 14, 2009, or (ii) LIBOR (or 2.75%, if LIBOR is less than 2.75%), plus a margin equal to
(x) 5% for the period commencing on the closing date through April 14, 2009, or (y) a percentage
that ranged between 4.75% and 5.25% for the period after April 14, 2009. Upon the occurrence of any
event of default, we were to pay interest equal to an additional 2.0% per year. The Credit
Agreement contained affirmative, negative and financial covenants customary for financings of this
type. The negative covenants included restrictions on liens, indebtedness, payments of dividends,
disposition of assets, fundamental changes, loans and investments, transactions with affiliates and
negative pledges. The financial covenants included fixed charge coverage ratio, minimum-EBITDA,
minimum liquidity and a maximum level of capital expenditures. In addition, our obligations under
the Credit Agreement could have been accelerated upon the occurrence of an event of default under
the Credit Agreement, which included customary events of default such as payment defaults, defaults
in the performance of affirmative and negative covenants, the inaccuracy of representations or
warranties, bankruptcy and insolvency related defaults, defaults relating to judgments, defaults
relating to certain governmental enforcement actions, and a change of control default. The Credit
Facility would have terminated, and all amounts outstanding thereunder would have been due and
payable, on January 7, 2013, or on an earlier date as specified in the Credit Agreement.
Also on January 7, 2009, in connection with the Credit Agreement, we entered into a
Guaranty and Security Agreement (Guaranty and Security Agreement) with GE Capital, as agent for
the Lenders and each other secured party thereunder. Pursuant to the Guaranty and Security
Agreement, we had granted a security interest to GE Capital in the collateral described in the
Guaranty and Security Agreement as security for the Credit Facility. Our obligations were secured
by substantially all of our assets, excluding our ownership interest in Akorn-Strides, LLC and in
certain licenses and other property in which assignments are prohibited by confidential provisions.
In connection with the Credit Agreement, on January 7, 2009, we also entered into a
Mortgage, Security Agreement, Assignment of Leases and Rents, Financing Statement and Fixture
Filing by us, in favor of GE Capital, relating to the real property owned by us located in Decatur,
Illinois. The Mortgages granted a security interest in the two parcels of real property to GE
Capital, as security for the Credit Facility.
Also on January 7, 2009, in connection with the Credit Agreement, we entered into a
Subordination Agreement with the Kapoor Trust and GE Capital, as agent for the Lenders. Pursuant to
the Subordination Agreement, the Kapoor Trust agreed that our debt pursuant to the Subordinated
Promissory Note dated as of July 28, 2008, in the principal amount of $5,000,000 (Subordinated
Note) payable to the Kapoor Trust was subordinated to the Credit Facility, except that so long as
there was no event of default outstanding under the Credit Agreement, we could repay the
Subordinated Note in full if the repayment occurred by July 28, 2009.
On February 19, 2009, GE Capital informed us that it was applying a reserve against
availability which effectively restricted our borrowings under the Credit Agreement to the balance
outstanding as of February 19, 2009, which was $5,523,620. GE Capital advised that it was applying
this reserve due to concerns about financial performance, including our prospective compliance with
certain covenants in the Credit Agreement for the quarter ended March 31, 2009.
On March 31, 2009, we consented to an Assignment Agreement (Assignment) between GE Capital
and EJ Funds LP (EJ Funds) which transferred to EJ Funds all of GE Capitals rights and
obligations under the Credit Agreement. Pursuant to the
20
Assignment, EJ Funds became the agent and lender under the Credit Agreement. Accordingly, GE
Capital is no longer our lender. Dr. Kapoor is the President of EJ Financial Enterprises, Inc., a
healthcare consulting investment company (EJ Financial) and EJ Financial is the general partner
of EJ Funds.
In connection with the Assignment, on April 13, 2009, we entered into a Modification, Warrant
and Investor Rights Agreement (the Modification Agreement) with EJ Funds that, among other
things, (i) reduced the revolving loan commitment under the Credit Agreement to $5,650,000, (ii)
provided an extended cure period until July 22, 2009 for any event, other than specified types of
Material Defaults listed in the Modification Agreement, which could constitute an Event of
Default under the Credit Agreement, unless that period is terminated earlier due to the occurrence
of a Material Default or as otherwise provided in the Modification Agreement, (iii) set the
interest rate for all amounts outstanding under the Credit Agreement at an annual rate of 10% with
interest payable monthly, (iv) granted a security interest in and lien upon all the collateral
under the Credit Agreement to the Kapoor Trust as security for the Subordinated Note, and (v)
requires us, within 30 days after the date of the Modification Agreement, to enter into security
documents consisting of a security agreement and mortgages (if requested by the Kapoor Trust) in
form and substance substantially similar to the corresponding security documents under the Credit
Agreement for the Kapoor Trusts interest in connection with the Subordinated Note. The
Modification Agreement also granted EJ Funds the right to require us to nominate two directors to
serve on our Board of Directors. The Kapoor Trust is entitled to require us to nominate a third
director under our Stock Purchase Agreement dated November 15, 1990 with the Kapoor Trust. In
addition, we agreed to pay all accrued legal fees and other expenses of EJ Funds that relate to the
Credit Agreement and other loan documents, including legal expenses incurred with respect to the
Modification Agreement and the Assignment.
Pursuant to the Modification Agreement, on April 13, 2009 we granted EJ Funds a warrant (the
Modification Warrant) to purchase 1,939,639 shares of our common stock at an exercise price of
$1.11 per share, subject to certain adjustments. The Modification Warrant expires five years after
its date of issuance and is exercisable upon payment of the exercise price in cash or by means of a
cashless exercise yielding a net share figure. Under the Modification Agreement, we have the right
to convert the Subordinated Note into term indebtedness under the Credit Agreement in exchange for
additional warrants, on terms substantially identical to the Modification Warrant, to purchase
343,299 shares of our common stock for each $1,000,000 of converted debt. The exercise price of
those warrants would also be $1.11 per share. The estimated fair value of the Modification
Warrant, using a Black-Scholes valuation model, is $1,357,747. This
amount was capitalized as deferred financing costs and is included
in other long term assets in the accompanying balance sheet.
Subordinated Debt
On July 28, 2008, we borrowed $5,000,000 from the Kapoor Trust in return for issuing the trust
a Subordinated Note. The note accrues interest at a rate of 15% per year and is due and payable on
July 28, 2009. The proceeds from this note were used in conjunction with the amended MBL
Distribution Agreement, which resulted in favorable pricing and reduced purchase commitments (see
also Note L Commitments and Contingencies).
CONTRACTUAL OBLIGATIONS
In
July 2008, we amended our Exclusive Distribution Agreement with MBL dated as of March 22, 2007
(the MBL Distribution Agreement) to: (i) allow us to destroy our remaining inventory of Tetanus
Diphtheria vaccine, 15 dose/vial, in exchange for receiving an equivalent number of doses of
preservative-free Tetanus Diphtheria vaccine, 1 dose/vial (the Single-dose Product) at no
additional cost other than destruction and documentation expenses; (ii) reduce the purchase price
of the Single-dose Product during the first year of the MBL Distribution Agreement by approximately
14.4%; (iii) reduce our purchase commitment for the second year by approximately 34.7%; and (iv)
reduce our purchase commitment for the third year by approximately 39.5%.
We were subsequently unable to make a payment of approximately $3,375,000 for Td vaccine
products which was due to MBL by February 27, 2009 under the MBL Distribution Agreement. While we
made a partial payment of $1,000,000 to MBL on March 13, 2009, we were unable to make another
payment of approximately $3,375,000 due to MBL on March 28, 2009. Accordingly, we entered into a
letter agreement with MBL on March 27, 2009 (MBL Letter Agreement), pursuant to which we agreed
to pay MBL the $5,750,000 remaining due for these Td vaccine products plus an additional $4,750,000
in consideration of the amendments to the MBL Distribution Agreement payable according to a
periodic payment schedule through June 30, 2010 (the Settlement Payments). In addition, pursuant
to the MBL Letter Agreement, the MBL Distribution Agreement was converted to a non-exclusive
agreement, we became obligated to
21
provide MBL with a standby letter of credit to secure our obligation to pay amounts due to MBL
(the L/C), and we were released from our obligation to further purchase Td vaccine products from
MBL upon providing MBL with such L/C. In addition, pursuant to the MBL Letter Agreement, MBL
agreed not to declare a breach or otherwise act to terminate the MBL Distribution Agreement if we
complied with the terms of the MBL Letter Agreement, the MBL Distribution Agreement (as amended by
the MBL Letter Agreement) and any agreements required to be entered into pursuant to the MBL Letter
Agreement.
On April 15, 2009, we entered into a Settlement Agreement with MBL (the MBL Settlement
Agreement) to elaborate the MBL Letter Agreement. The MBL Settlement Agreement provides that we
will pay MBL the Settlement Payments according to a monthly payment schedule through June 30, 2010.
The MBL Settlement Agreement provides that MBL may only draw on the L/C if: (i) we fail to make any
Settlement Payment when due, (ii) any Settlement Payment made is set aside or otherwise required to
be repaid by MBL, or (iii) we become the debtor in a bankruptcy or other insolvency proceeding
begun before October 6, 2010 and no replacement letter of credit has been issued prior to the
expiration of the L/C.
Also on April 15, 2009, we entered into an amendment to the MBL Distribution Agreement with
MBL (the MBL Amendment). The MBL Amendment modified the MBL Distribution Agreement to, among
other things, eliminate our future minimum purchase requirements under the MBL Distribution
Agreement.
On April 15, 2009, we also entered into a Reimbursement and Warrant Agreement (the
Reimbursement Agreement) with EJ Funds and the Kapoor Trust, pursuant to which the Kapoor Trust
agreed to provide the L/C as security for our payment obligations to MBL under the MBL Letter
Agreement and the MBL Settlement Agreement. Simultaneous with the delivery of the Reimbursement
Agreement, the L/C was issued by the Bank of America in favor of MBL. The Reimbursement Agreement
provides, among other things, that we will reimburse the Kapoor Trust for any draws by MBL under
the L/C through the mechanism of causing the amount of the draws to become term indebtedness
payable to the Kapoor Trust on the same terms as the revolving debt under the Credit Agreement. All
of our obligations under the Reimbursement Agreement will also be considered secured obligations
under the Credit Agreement. Pursuant to the Reimbursement Agreement, we also issued a warrant to
the Kapoor Trust (the Reimbursement Warrant) to purchase 1,501,933 shares of our common stock at
an exercise price of $1.11 per share, subject to certain adjustments. The Reimbursement Warrant
expires five years from the date of issuance and is exercisable upon payment of the exercise price
in cash or by means of a cashless exercise yielding a net share figure. In addition, the
Reimbursement Agreement provides that we must issue the Kapoor Trust additional warrants, at that
same price of $1.11 per share, to purchase 200,258 shares of our common stock per $1,000,000 drawn
on the L/C. The estimated fair value of the Reimbursement Warrant, using a Black-Scholes valuation
model, is $1,051,353. This amount is recorded in supply agreement
termination expenses in the accompanying statement of operations.
The shares of our common stock issuable upon exercise of the Modification Warrant and the
Reimbursement Warrant, along with those other warrants that may be issued under the Modification
Agreement and Reimbursement Agreement and other shares of common stock held by EJ Funds, the Kapoor
Trust and their affiliates, are subject to registration rights as set forth in the Modification
Agreement. Under the Modification Agreement, we agreed to file a registration statement with the
SEC within 75 days of the date of the Modification Agreement. We also agreed to continue the
effectiveness of the registration statement until the earliest of the dates (i) all securities
registrable thereunder have been sold, (ii) all such registrable securities may be sold in a single
transaction by their holders to the public under Rule 144 under the Securities Act, and (iii) no
shares of our common stock registered under the registration statement qualify as registrable
securities thereunder.
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 Item 1. Financial Statements, Note B Summary of Significant Accounting Policies,
which are included in our Annual Report on Form 10-K for the year ended December 31, 2008. 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, 2008. There have been no significant
changes in the application of the critical accounting policies since December 31, 2008.
22
RECENT ACCOUNTING PRONOUNCEMENTS
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value, and expands disclosures
about fair value measurements. SFAS 157 is effective for financial statements issued for fiscal
years beginning after November 15, 2007. In February of 2008, the FASB issued FASB Staff position
157-2 which delays the effective date of SFAS 157 for non-financial assets and liabilities which
are not measured at fair value on a recurring basis (at least annually) until fiscal years
beginning after November 15, 2008. We adopted SFAS 157 effective January 1, 2008 and the adoption
did not have a material impact on our results of operation or financial position.
In December 2007, the FASB issued SFAS No. 160, Non-Controlling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS 160). SFAS 160 establishes new standards
for the accounting for and reporting of non-controlling interests (formerly minority interests) and
for the loss of control of partially owned and consolidated subsidiaries. SFAS 160 does not change
the criteria for consolidating a partially owned entity. SFAS 160 is effective for fiscal years
beginning after December 15, 2008. We adopted SFAS 160 effective
January 1, 2009 and the adoption did not have a material impact on
our consolidated financial statements.
In December 2007, the FASB issued SFAS No. 141 (revised 2007) (SFAS 141R), a revision of
SFAS 141, Business Combinations. SFAS 141R establishes requirements for the recognition and
measurement of acquired assets, liabilities, goodwill, and non-controlling interests. SFAS 141R
also provides disclosure requirements related to business combinations. SFAS 141R is effective for
fiscal years beginning after December 15, 2008. SFAS 141R will be applied prospectively to
business combinations with an acquisition date on or after the effective date.
In April 2008, the FASB issued FSP SFAS No. 142-3, Determination of the Useful Life of
Intangible Assets. The FSP amends the factors that should be considered in developing renewal or
extension assumptions used to determine the useful life of a recognized intangible asset under SFAS
No. 142, Goodwill and Other Intangible Assets. The intent of the FSP is to improve the consistency
between the useful life of a recognized intangible asset under SFAS No. 142 and the period of
expected cash flows used to measure the fair value of the asset under SFAS No. 141 (revised 2007),
Business Combinations, and other U.S. GAAP. The FSP is effective for financial statements issued
for fiscal years beginning after December 15, 2008, and interim periods within those fiscal years.
We adopted FSP SFAS No. 142-3 effective January 1, 2009 and the
adoption did not have a material impact on our consolidated financial
statements.
OFF-BALANCE SHEET ARRANGEMENTS
We do not have any off-balance sheet arrangements that have had, or are reasonably likely to
have, a current or future material effect on our financial condition, changes in financial
condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital
resources.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are not subject to market risk associated with changes in interest rates as our interest
rates on the Subordinated Note and the Credit Facility are both fixed interest rates.
We have no material foreign exchange risk. We have no market risk sensitive instruments
entered into for trading purposes.
Our financial instruments consist mainly of cash, accounts receivable, accounts payable and
debt. The carrying amounts of these instruments, except debt, approximate fair value due to their
short-term nature. The carrying amounts of our bank borrowings under our debt instruments
approximate fair value because the interest rates are reset periodically to reflect current market
rates.
The fair value of the debt obligations approximated the recorded value as of March 31, 2009.
23
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
An evaluation was performed, under the supervision and with the participation of Company
management, including the Interim Chief Executive Officer (CEO) and Chief Financial Officer
(CFO), of the effectiveness of the design and operation of the Companys disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the
Act)). There are inherent limitations to the effectiveness of any system of disclosure controls
and procedures, including cost limitations, judgments used in decision making, assumptions
regarding the likelihood of future events, soundness of internal controls, fraud, the possibility
of human error and the circumvention or overriding of the controls and procedures. Accordingly,
even effective disclosure controls and procedures can provide only reasonable, and not absolute,
assurance of achieving their control objectives. Based on that evaluation, management, including
the Interim CEO and CFO, has concluded that, as of March 31, 2009, the Companys disclosure
controls and procedures were effective in all material respects at the reasonable assurance level
to ensure that information required to be disclosed in reports that the Company files or submits
under the Act is recorded, processed, summarized and timely reported in accordance with the rules
and forms of the SEC.
Changes in Internal Control Over Financial Reporting
In the fiscal quarter ended March 31, 2009, there has been no change in the Companys internal
control over financial reporting that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
24
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, at this time we do not believe that
such proceedings will have a material adverse impact on our financial condition, results of
operations, or cash flows.
On April 3, 2009, our former President and Chief Executive Officer, Arthur Przybyl, filed a
demand for arbitration against the Company under his April 24, 2006 Executive Employment Agreement
(the Employment Agreement). A copy of the Employment Agreement is Exhibit 10.1 to the Current
Report on Form 8-K we filed with the SEC on April 28, 2006. Mr. Przybyl initiated this arbitration
with the Chicago, Illinois office of the American Arbitration Association under an arbitration
provision in the Employment Agreement.
In his arbitration demand, Mr. Przybyl seeks severance and related benefits that would have
been payable under the Employment Agreement were Mr. Przybyl terminated without cause and he met
additional requirements. Severance would have included 18 months of Mr. Przybyls base salary and
a cash bonus equal to 1.5 times the average of the last two annual bonuses received by Mr. Przybyl.
The salary component would have been $715,500 and, because Mr. Przybyl received no bonus for 2007
or 2008, we believe the bonus component would have been $0. Mr. Przybyls arbitration demand
states that he seeks more than $1,250,000.
We originally anticipated that we would pay severance to Mr. Przybyl. However, we later
concluded that we had grounds for terminating Mr. Przybyl for good cause as that term is defined
in the Employment Agreement. Accordingly, we advised Mr. Przybyl about that conclusion, after
which Mr. Przybyl initiated the arbitration. In our response to Mr. Przybyls claim that we filed
in the arbitration, we asserted counterclaims against Mr. Przybyl for (among other things) breach
of contract and breach of fiduciary duty. We seek affirmative monetary relief under our
counterclaims. The arbitration is in its very early stages, and no arbitration hearing date has
been set.
ITEM 1A. RISK FACTORS
There have been no material changes from the risk factors disclosed in Part 1, Item 1A, of our
Form 10-K filed March 30, 2009.
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 shares of our Series A Preferred Stock, shares of Series B Preferred Stock, warrants
and convertible notes, including shares estimated to be issuable or that have been issued 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 on such
securities. All shares of Series A Preferred Stock, Series B Preferred Stock and all convertible
notes have been converted to shares of our common stock.
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 March 31, 2009, we are aware of the sale of 20,554,359 shares of common stock by
selling stockholders
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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. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
26
ITEM 6. EXHIBITS
Those exhibits marked with a (*) refer to exhibits filed herewith. The other exhibits are
incorporated herein by reference, as indicated in the following list. Portions of the exhibits
marked with a (W) are the subject of a Confidential Treatment Request under 17 C.F.R. §§
200.80(b)(4), 200.83 and 240.24b-2.
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Exhibit |
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No. |
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Description |
(4.1)
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Akorn, Inc. Common Stock Purchase Warrant, dated April 13, 2009, in favor of EJ Funds
LP, incorporated by reference to Exhibit 4.1 to Akorn, Inc.s report on Form 8-K
filed on April 17, 2009. |
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(4.2)
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Modification, Warrant and Investor Rights Agreement, dated April 13, 2009, among
Akorn, Inc., Akorn (New Jersey), Inc., and EJ Funds LP, incorporated by reference to
Exhibit 4.2 to Akorn, Inc.s report on Form 8-K filed on April 17, 2009. |
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(4.3)
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Akorn, Inc. Common Stock Purchase Warrant, dated April 15, 2009, in favor of 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 April 21, 2009. |
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(10.1)
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Credit Agreement dated January 7, 2009, by and between Akorn, Inc., Akorn (New
Jersey), Inc. and General Electric Capital Corporation, incorporated by reference to
Exhibit 10.1 to Akorn Inc.s report on Form 8-K filed on January 9, 2009. |
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(10.2)W
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Letter Agreement dated March 27, 2009 between Akorn, Inc. and Massachusetts Biologic
Laboratories of the University of Massachusetts Medical School, incorporated by
reference to Exhibit 10.72 to Akorn, Incs report on Form 10-K for the fiscal year
ended December 31, 2008, filed on March 30, 2009. |
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(10.3)
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Memorandum of Agreement, dated March 31, 2009, among EJ Funds LP, Akorn Inc., and
Akorn (New Jersey), Inc., incorporated by reference to Exhibit 10.1 to Akorn Inc.s
report on Form 8-K filed on April 6, 2009. |
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(10.4)
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Assignment, dated March 31, 2009, among General Electric Capital Corporation, EJ
Funds LP, Akorn, Inc., and Akorn (New Jersey), Inc., incorporated by reference to
Exhibit 10.2 to Akorn Inc.s report on Form 8-K filed on April 6, 2009. |
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(10.5)
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Reimbursement and Warrant Agreement, dated April 15, 2009, among Akorn, Inc. Akorn
(New Jersey), Inc., John N. Kapoor Trust dated 09/20/89, and EJ Funds LP,
incorporated by reference to Exhibit 10.1 to Akorn Inc.s report on Form 8-K filed on
April 21, 2009. |
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(10.6)W
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Settlement Agreement, dated April 15, 2009, between Akorn, Inc. and Massachusetts
Biologic Laboratories of the University of Massachusetts Medical School, incorporated
by reference to Exhibit 10.2 to Akorn Inc.s report on Form 8-K filed on April 21,
2009. |
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(10.7)W
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Fourth Amendment to Exclusive Distribution Agreement, dated April 15, 2009, between
Akorn, Inc. and Massachusetts Biologic Laboratories of the University of
Massachusetts Medical School, incorporated by reference to Exhibit 10.2 to Akorn
Inc.s report on Form 8-K filed on April 21, 2009. |
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(31.1)*
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Certification of Chief Executive Officer pursuant to Rule 13a-14(a). |
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(31.2)*
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Certification of Chief Financial Officer pursuant to Rule 13a-14(a). |
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(32.1)*
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Certification of Chief Executive Officer pursuant to 18 U.S.C. § 1350. |
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(32.2)*
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Certification of Chief Financial Officer pursuant to 18 U.S.C. § 1350. |
27
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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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 |
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(Duly Authorized and Principal Financial Officer) |
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Date: May 11, 2009
28