e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED September 30, 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
(State or Other Jurisdiction of
Incorporation or Organization)
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72-0717400
(I.R.S. Employer
Identification No.) |
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|
1925 W FIELD CT STE 300
LAKE FOREST, ILLINOIS
(Address of Principal Executive Offices)
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|
60045
(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
o 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 definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act.
Large accelerated filer o |
Accelerated filer þ |
Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company o
|
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 October 31, 2009 there were 90,387,722 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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SEPTEMBER 30, |
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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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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
2,018 |
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$ |
1,063 |
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Trade accounts receivable (less allowance for doubtful accounts
of $2 and $22, respectively) |
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|
11,360 |
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6,529 |
|
Other receivable |
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1,221 |
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Inventories |
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17,409 |
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30,163 |
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Prepaid expenses and other current assets |
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|
485 |
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1,770 |
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TOTAL CURRENT ASSETS |
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31,272 |
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40,746 |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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32,169 |
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34,223 |
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OTHER LONG-TERM ASSETS |
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Intangibles, net |
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5,033 |
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6,017 |
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Deferred financing costs, net |
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4,060 |
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|
272 |
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Other |
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1,892 |
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|
1,071 |
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TOTAL OTHER LONG-TERM ASSETS |
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10,985 |
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7,360 |
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TOTAL ASSETS |
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$ |
74,426 |
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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 |
|
$ |
4,458 |
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$ |
8,795 |
|
Accrued compensation |
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|
1,469 |
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|
1,070 |
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Accrued expenses and other liabilities |
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3,856 |
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2,906 |
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Short term subordinated debt related party |
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5,332 |
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Revolving line of credit related party |
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7,509 |
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Warrants liability related party |
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6,654 |
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Supply agreement termination costs |
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1,500 |
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TOTAL CURRENT LIABILITIES |
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25,446 |
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18,103 |
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LONG-TERM LIABILITIES |
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Lease incentive obligation |
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1,350 |
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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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Subordinated note related party |
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5,853 |
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TOTAL LONG-TERM LIABILITIES |
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8,502 |
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|
2,783 |
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TOTAL LIABILITIES |
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33,948 |
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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;
90,340,678 and 90,072,662 shares issued and outstanding at
September 30, 2009 and December 31, 2008, respectively |
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|
173,304 |
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170,617 |
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Warrants to acquire common stock |
|
|
1,821 |
|
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|
2,731 |
|
Accumulated deficit |
|
|
(134,647 |
) |
|
|
(111,905 |
) |
|
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TOTAL SHAREHOLDERS EQUITY |
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40,478 |
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|
61,443 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
74,426 |
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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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NINE MONTHS ENDED |
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SEPTEMBER 30, |
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SEPTEMBER 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Revenues |
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$ |
19,371 |
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$ |
31,874 |
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$ |
57,711 |
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$ |
67,562 |
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Cost of sales |
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16,686 |
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21,968 |
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47,997 |
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49,082 |
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GROSS PROFIT |
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2,685 |
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9,906 |
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9,714 |
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18,480 |
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Selling, general and administrative expenses |
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5,187 |
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6,199 |
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18,016 |
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18,370 |
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Supply agreement termination expenses |
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5,929 |
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Amortization of intangibles |
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320 |
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|
339 |
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1,234 |
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1,016 |
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Research and development expenses |
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1,013 |
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1,143 |
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3,681 |
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4,744 |
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TOTAL OPERATING EXPENSES |
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6,520 |
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7,681 |
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28,860 |
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24,130 |
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OPERATING (LOSS) INCOME |
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|
(3,835 |
) |
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|
2,225 |
|
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|
(19,146 |
) |
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|
(5,650 |
) |
Write-off and amortization of deferred financing
costs |
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|
(187 |
) |
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(1,739 |
) |
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Interest expense, net |
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|
(441 |
) |
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(295 |
) |
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(1,095 |
) |
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|
(579 |
) |
Equity in earnings of unconsolidated joint venture |
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|
484 |
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|
447 |
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|
672 |
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|
447 |
|
Change in fair value of warrants liability |
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|
(1,122 |
) |
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(1,432 |
) |
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Other income (expense) |
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24 |
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(177 |
) |
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|
(LOSS) INCOME BEFORE INCOME TAXES |
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|
(5,101 |
) |
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|
2,401 |
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|
(22,740 |
) |
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|
(5,959 |
) |
Income tax provision |
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|
|
|
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|
2 |
|
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|
3 |
|
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|
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|
NET (LOSS) INCOME |
|
$ |
(5,101 |
) |
|
$ |
2,401 |
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|
$ |
(22,742 |
) |
|
$ |
(5,962 |
) |
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NET (LOSS) INCOME PER SHARE: |
|
|
|
|
|
|
|
|
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|
|
|
|
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|
BASIC |
|
$ |
(0.06 |
) |
|
$ |
0.03 |
|
|
$ |
(0.25 |
) |
|
$ |
(0.07 |
) |
|
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DILUTED |
|
$ |
(0.06 |
) |
|
$ |
0.03 |
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|
$ |
(0.25 |
) |
|
$ |
(0.07 |
) |
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|
SHARES USED IN COMPUTING NET (LOSS) INCOME PER
SHARE: |
|
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|
|
|
|
|
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|
|
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|
BASIC |
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|
90,303 |
|
|
|
89,250 |
|
|
|
90,209 |
|
|
|
89,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
90,303 |
|
|
|
90,065 |
|
|
|
90,209 |
|
|
|
89,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See notes to condensed consolidated financial statements.
4
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENT OF SHAREHOLDERS EQUITY
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2009 AND 2008
UNAUDITED
(In Thousands)
|
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Warrants to |
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|
|
|
|
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|
|
|
|
|
|
|
|
acquire |
|
|
|
|
|
|
|
|
|
Common Stock |
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Common |
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|
Accumulated |
|
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|
Nine Months Ended September 30, 2009 |
|
Shares |
|
|
Amount |
|
|
Stock |
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|
Deficit |
|
|
Total |
|
BALANCES AT DECEMBER 31, 2008 |
|
|
90,073 |
|
|
$ |
170,617 |
|
|
$ |
2,731 |
|
|
$ |
(111,905 |
) |
|
$ |
61,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(22,742 |
) |
|
|
(22,742 |
) |
Employee stock purchase plan issuances |
|
|
122 |
|
|
|
149 |
|
|
|
|
|
|
|
|
|
|
|
149 |
|
Amortization of deferred compensation
related to restricted stock awards |
|
|
146 |
|
|
|
286 |
|
|
|
|
|
|
|
|
|
|
|
286 |
|
Restricted stock awards vested net of
amounts withheld for payment of
employee tax liability |
|
|
|
|
|
|
(47 |
) |
|
|
|
|
|
|
|
|
|
|
(47 |
) |
Stock-based compensation expense |
|
|
|
|
|
|
1,389 |
|
|
|
|
|
|
|
|
|
|
|
1,389 |
|
Expiration of stock warrants |
|
|
|
|
|
|
910 |
|
|
|
(910 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCES AT SEPTEMBER 30, 2009 |
|
|
90,341 |
|
|
$ |
173,304 |
|
|
$ |
1,821 |
|
|
$ |
(134,647 |
) |
|
$ |
40,478 |
|
|
|
|
|
|
|
|
|
|
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|
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|
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Warrants to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
acquire |
|
|
|
|
|
|
|
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|
Common Stock |
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|
Common |
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|
Accumulated |
|
|
|
|
Nine Months Ended September 30, 2008 |
|
Shares |
|
|
Amount |
|
|
Stock |
|
|
Deficit |
|
|
Total |
|
BALANCES AT DECEMBER 31, 2007 |
|
|
88,901 |
|
|
$ |
165,829 |
|
|
$ |
2,795 |
|
|
$ |
(103,966 |
) |
|
$ |
64,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,962 |
) |
|
|
(5,962 |
) |
Exercise of warrants into common stock |
|
|
50 |
|
|
|
101 |
|
|
|
(64 |
) |
|
|
|
|
|
|
37 |
|
Exercise of stock options |
|
|
217 |
|
|
|
608 |
|
|
|
|
|
|
|
|
|
|
|
608 |
|
Employee stock purchase plan issuances |
|
|
31 |
|
|
|
149 |
|
|
|
|
|
|
|
|
|
|
|
149 |
|
Amortization of deferred compensation
related to restricted stock awards |
|
|
|
|
|
|
492 |
|
|
|
|
|
|
|
|
|
|
|
492 |
|
Restricted stock awards vested net of
amounts withheld for payment of
employee tax liability |
|
|
66 |
|
|
|
(158 |
) |
|
|
|
|
|
|
|
|
|
|
(158 |
) |
Stock-based compensation expense |
|
|
|
|
|
|
1,329 |
|
|
|
|
|
|
|
|
|
|
|
1,329 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCES AT SEPTEMBER 30, 2008 |
|
|
89,265 |
|
|
$ |
168,350 |
|
|
$ |
2,731 |
|
|
$ |
(109,928 |
) |
|
$ |
61,153 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
NINE MONTHS |
|
|
|
ENDED SEPTEMBER 30 |
|
|
|
2009 |
|
|
2008 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(22,742 |
) |
|
$ |
(5,962 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
4,118 |
|
|
|
3,348 |
|
Write-off and amortization of deferred financing fees |
|
|
1,739 |
|
|
|
|
|
Non-cash stock compensation expense |
|
|
1,675 |
|
|
|
1,821 |
|
Non-cash supply agreement termination expense |
|
|
1,051 |
|
|
|
|
|
Non-cash change in fair value of warrants liability |
|
|
1,432 |
|
|
|
|
|
Gain on disposal of assets |
|
|
|
|
|
|
(25 |
) |
Equity in earnings of unconsolidated joint venture |
|
|
(672 |
) |
|
|
(447 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Trade accounts receivable |
|
|
(4,831 |
) |
|
|
(11,620 |
) |
Inventories |
|
|
12,754 |
|
|
|
2,662 |
|
Prepaid expenses and other current assets |
|
|
1,228 |
|
|
|
252 |
|
Other long-term assets |
|
|
|
|
|
|
1,246 |
|
Supply agreement termination liabilities |
|
|
1,500 |
|
|
|
|
|
Trade accounts payable |
|
|
(4,337 |
) |
|
|
(6,651 |
) |
Accrued expenses and other liabilities |
|
|
1,736 |
|
|
|
1,081 |
|
|
|
|
|
|
|
|
NET CASH USED IN OPERATING ACTIVITIES |
|
|
(5,349 |
) |
|
|
(14,295 |
) |
INVESTING ACTIVITIES |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(922 |
) |
|
|
(2,742 |
) |
Purchase of product licensing rights |
|
|
(250 |
) |
|
|
|
|
Proceeds from sale of fixed assets |
|
|
|
|
|
|
74 |
|
|
|
|
|
|
|
|
NET CASH USED IN INVESTING ACTIVITIES |
|
|
(1,172 |
) |
|
|
(2,668 |
) |
FINANCING ACTIVITIES |
|
|
|
|
|
|
|
|
Repayment of long-term debt |
|
|
|
|
|
|
(208 |
) |
Restricted cash for revolving credit agreement |
|
|
|
|
|
|
(2,050 |
) |
Loan origination fees new revolving line of credit & subordinated note |
|
|
(1,356 |
) |
|
|
|
|
Proceeds from line of credit |
|
|
7,509 |
|
|
|
5,727 |
|
Proceeds from warrants exercised |
|
|
|
|
|
|
37 |
|
Proceeds from subordinated note |
|
|
|
|
|
|
5,000 |
|
Proceeds under stock option and stock purchase plans |
|
|
1,323 |
|
|
|
599 |
|
|
|
|
|
|
|
|
NET CASH PROVIDED BY FINANCING ACTIVITIES |
|
|
7,476 |
|
|
|
9,105 |
|
|
|
|
|
|
|
|
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
955 |
|
|
|
(7,858 |
) |
Cash and cash equivalents at beginning of period |
|
|
1,063 |
|
|
|
7,948 |
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
$ |
2,018 |
|
|
$ |
90 |
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES |
|
|
|
|
|
|
|
|
Amount paid for interest |
|
$ |
387 |
|
|
$ |
534 |
|
Amount paid for income taxes |
|
$ |
3 |
|
|
$ |
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 nine-month
period ended September 30, 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 filed with the Securities and Exchange Commission (the SEC) on March 30, 2009.
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
(97% in the quarter ended September 30, 2009 and 95% in the previous quarters in 2009 and all
quarters in 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 product and by customer in some cases. The Company estimates its
sales returns reserve based on a historical percentage of returns to sales. 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
Stock-based 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 grant date fair value of stock options. 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. The Company estimates forfeitures at the time of grant and revises 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 2006 and 2007 to 13% as an estimated forfeiture rate commencing in the fourth quarter 2008
and all quarters in 2009.
The Company recognized stock-based compensation expense related to options of $339,000 and
$1,389,000 during the three and nine-month periods ended September 30, 2009, respectively.
Stock-based compensation expense related to options of $438,000 and $1,329,000 was recognized
during the three and nine-month periods ended September 30, 2008. The Company uses the single-award
method for allocating the compensation cost to each period.
The weighted-average assumptions used in estimating the grant date fair value of the stock
options granted during the three months ended September 30, 2009 and 2008, along with the
weighted-average grant date fair values, were as follows:
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS |
|
THREE MONTHS |
|
|
ENDED |
|
ENDED |
|
|
SEPTEMBER 30, 2009 |
|
SEPTEMBER 30, 2008 |
|
|
|
Expected volatility |
|
|
81 |
% |
|
|
48 |
% |
Expected life (in years) |
|
|
3.9 |
|
|
|
4.0 |
|
Risk-free interest rate |
|
|
2.5 |
% |
|
|
3.1 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
Fair value per stock option |
|
$ |
0.81 |
|
|
$ |
1.79 |
|
Forfeiture rate |
|
|
13 |
% |
|
|
10 |
% |
A summary of stock-based compensation activity within the Companys stock-based compensation
plans for the nine-month period ended September 30, 2009 is as follows:
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
$ |
44 |
|
Granted |
|
|
1,213 |
|
|
|
1.08 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(1,769 |
) |
|
|
5.06 |
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2009 |
|
|
3,128 |
|
|
|
3.68 |
|
|
|
2.99 |
|
|
$ |
401 |
|
|
Exercisable at September 30, 2009 |
|
|
1,557 |
|
|
|
5.01 |
|
|
|
1.83 |
|
|
$ |
18 |
|
|
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 nine
months 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 grants. The Company granted restricted stock awards valued at
$174,000 during the third quarter of 2009. As of September 30, 2009, the total amount of
unrecognized compensation expense related to nonvested restricted stock awards was $219,000. The
Company recognized compensation expense of $93,000 and $286,000 during the three and nine-month
periods ended September 30, 2009, related to outstanding restricted stock awards. The Company
recognized compensation expense of $134,000 and $492,000 during the three and nine-month periods
ended September 30, 2008, related to outstanding 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 |
|
|
185 |
|
|
|
1.59 |
|
Vested |
|
|
(202 |
) |
|
|
3.55 |
|
|
Nonvested at September 30, 2009 |
|
|
108 |
|
|
|
2.73 |
|
|
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.
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
9
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 accompanying
balance sheets.
Net trade accounts receivable consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, |
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Gross accounts receivable |
|
$ |
17,140 |
|
|
$ |
18,723 |
|
Less: |
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
|
(2 |
) |
|
|
(22 |
) |
Returns reserve |
|
|
(2,456 |
) |
|
|
(2,539 |
) |
Discount and allowances reserve |
|
|
(297 |
) |
|
|
(322 |
) |
Chargeback and rebates reserves |
|
|
(3,025 |
) |
|
|
(9,311 |
) |
|
|
|
|
|
|
|
Net trade accounts receivable |
|
$ |
11,360 |
|
|
$ |
6,529 |
|
|
|
|
|
|
|
|
For the three-month periods ended September 30, 2009 and 2008, the Company recorded chargeback
and rebate expense of $6,238,000 and $7,390,000, respectively. For the nine-month periods ended
September 30, 2009 and 2008, the Company recorded chargeback and rebate expense of $20,178,000 and
$23,566,000, respectively. These decreases for both the three and nine month periods were
primarily due to reduced sales into wholesalers and a favorable sales mix of lower chargeback
products in 2009.
For the three-month periods ended September 30, 2009 and 2008, the Company recorded a
provision for product returns of $489,000 and $764,000 respectively. For the nine-month periods
ended September 30, 2009 and 2008, the Company recorded a provision for product returns of
$3,809,000 and $1,714,000, respectively. The increase in the product returns provision for the nine months ended September 30, 2009 was primarily due to a
provision of $708,000 related to the Companys Akten® ophthalmic solution product, $242,000 in
additional returns for a product recall on the Companys Cyanide Antidote Kits due to a supplier
syringe recall, lower than anticipated market pull through on Ophthalmic products and also to
reflect increased returns anticipated from wholesalers on certain other products. Akten® was
launched in October 2008 and the significant returns were not previously anticipated as the Company
had expected to capture significant market share based on the products attributes. The Company
has continued a trial sampling and price reduction program which was implemented in the first half
of 2009, along with additional field sales coverage for key users to stimulate market demand for
this product.
For the three-month periods ended September 30, 2009 and 2008, the Company recorded a net
benefit for doubtful accounts of $16,000 and a net provision for doubtful accounts of $8,000,
respectively. For the nine-month periods ended September 30, 2009 and 2008, the Company recorded a
net benefit for doubtful accounts of $20,000 and a net provision for doubtful accounts of $8,000,
respectively.
For the three-month periods ended September 30, 2009 and 2008, the Company recorded a
provision for cash discounts of $379,000 and $618,000, respectively. This decrease primarily
relates to the decrease in sales for the quarter. For the nine-month periods ended September 30,
2009 and 2008, the Company recorded a provision for cash discounts of $1,246,000 and $1,409,000,
respectively. This decrease primarily relates to the decrease in sales for the respective nine
month periods.
NOTE F INVENTORIES
The components of inventories are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, |
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Finished goods |
|
$ |
8,120 |
|
|
$ |
21,000 |
|
Work in process |
|
|
1,901 |
|
|
|
1,802 |
|
Raw materials and supplies |
|
|
7,388 |
|
|
|
7,361 |
|
|
|
|
|
|
|
|
|
|
$ |
17,409 |
|
|
$ |
30,163 |
|
|
|
|
|
|
|
|
10
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
September 30, 2009 and December 31, 2008 is reported net of these reserves of $1,386,000 and
$1,179,000, respectively, primarily related to finished goods. At September 30, 2009, the Company
had $835,000 in its ending inventory for raw material and $149,000 for finished goods related to
its generic oral Vancomycin capsule product. The Company has not yet received U.S. Food and Drug
Administration (FDA) approval, however it believes that FDA approval is probable and it will be
able to fully realize the costs of this inventory upon FDA approval.
NOTE G PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
SEPTEMBER 30, |
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Land |
|
$ |
396 |
|
|
$ |
396 |
|
Buildings and leasehold improvements |
|
|
20,027 |
|
|
|
19,607 |
|
Furniture and equipment |
|
|
46,661 |
|
|
|
46,297 |
|
|
|
|
|
|
|
|
|
|
|
67,084 |
|
|
|
66,300 |
|
Accumulated depreciation |
|
|
(35,250 |
) |
|
|
(32,710 |
) |
|
|
|
|
|
|
|
|
|
|
31,834 |
|
|
|
33,590 |
|
Construction in progress |
|
|
335 |
|
|
|
633 |
|
|
|
|
|
|
|
|
Property, plant, and equipment, net |
|
$ |
32,169 |
|
|
$ |
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 Subordinated Note accrues interest at a rate of 15% per year and was
due and payable on July 28, 2009. The proceeds from the Subordinated 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) on July 14, 2008, which
resulted in favorable pricing and reduced purchase commitments for the Company (see Note L
Commitments and Contingencies).
On August 17, 2009, the Company refinanced its $5,000,000 subordinated debt payable to the
Kapoor Trust. The principal amount of $5,000,000 has been increased to $5,853,267 to include
accrued interest through August 16, 2009 (interest accruing thereafter is payable monthly) and the
annual interest rate of 15% remained unchanged. The term of the Subordinated Note has been
extended by an additional five years and is now due and payable on August 17, 2014. As part of
this refinancing agreement, the Company issued the Kapoor Trust an additional 2,099,935 warrants to
purchase the Companys common stock at an exercise price of $1.16, the closing price of the
Companys stock on August 14, 2009. The fair value of these warrants on August 17, 2009, using a
Black-Scholes valuation model, was $1,575,000 and this amount was capitalized as financing costs
and is being amortized over the term of the subordinated debt.
The fair value of these warrants increased from $1,575,000 on August 17, 2009 to approximately
$1,953,000 as of September 30, 2009 and this $378,000 increase in the fair value of the warrants
liability was reflected as a non-operating expense in the Companys condensed consolidated
statement of operations. Future increases or decreases in the fair value of these warrants will be
recorded in a similar manner.
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, which, as is more fully discussed below, was subsequently assigned. Pursuant to
the
11
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 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 mortgage 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
12
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.
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 fair value of the Modification
Warrant, using a Black-Scholes valuation model, is $1,784,000 at September 30, 2009.
The fair value of these warrants increased from $2,409,000 at March 31, 2009 to approximately
$3,166,000 as of September 30, 2009 and this $757,000 increase in the fair value of the warrants
liability was reflected as a non-operating expense in the Companys condensed consolidated
statement of operations. Future increases or decreases in the fair value of these warrants will be
recorded in a similar manner.
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 $153,000 for other costs
in association with the assignment of the Credit Facility. The Company is amortizing the fees
associated with the Credit Facility assignment on a straight-line basis over the remaining term of
the Credit Facility which amounted to $245,000 in amortization expense for the nine months ended
September 30, 2009.
On August 17, 2009, the Company completed negotiations with EJ Funds for additional capacity
on its Credit Facility, increasing the loan commitment from $5,650,000 to $10,000,000. The Credit
Facility is secured by the assets of the Company and is not subject to debt covenants until April
1, 2010. In connection with this loan commitment increase, the Company issued EJ Funds 1,650,806
warrants to purchase its common stock at an exercise price of $1.16, the closing price of the
Companys stock on August 14, 2009. The estimated fair value of these warrants, using a
Black-Scholes valuation model, was $1,238,000 on August 17, 2009, and this amount was capitalized
as financing costs and is being amortized over the remaining term of the Credit Facility.
The fair value of these warrants increased from $1,238,000 on August 17, 2009 to $1,535,000 as
of September 30, 2009 and this $297,000 increase in the fair value of the warrants liability was
reflected as a non-operating expense in the Companys condensed consolidated statement of
operations. Future increases or decreases in the fair value of these warrants will be recorded in
a similar manner.
The Company classified the fair value of the Modification Warrant and the warrants issued in
conjunction with its Reimbursement and Warrant Agreement (see Note L Commitments and
Contingencies) as a current liability in accordance with Accounting Standards Codification ASC
815-40-15-3 (formerly EITF 00-19, Accounting for Derivative Financial Instruments Indexed to, and
Potentially Settled in, a Companys Own Stock). This is a result of the requirement that the
shares to be issued upon exercise of the warrants be registered shares which cannot be absolutely
assured.
The liability at September 30, 2009 for all outstanding warrants has been estimated using a
Black-Scholes valuation model with the fair value per warrant ranging from $0.92 to $0.93. The
assumptions used in estimating the fair values at September 30, 2009 included expected life ranging
from 4.5 to 4.9 years, expected volatility of 81%, dividend yield of 0%, and risk-free interest
rate of 2.5%.
Series B Warrants
13
On August 23, 2004, in connection with an issuance of preferred stock to certain investors,
the Company issued warrants to purchase 1,566,667 shares of common stock exercisable until August
23, 2009, with an exercise price of $3.50 per share (the Series B Warrants). There were 455,556
Series B Warrants outstanding on August 23, 2009 and the book value of these warrants was
reclassified to Common Stock on the Companys financial
statements as the warrants expired unexercised.
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 September 30,
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)/income per common share is based upon weighted average number of common
shares outstanding. Diluted net (loss)/income 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 period ended September 30,
2009 and the nine-month periods ended September 30, 2009 and 2008, the assumed exercise of any of
these securities would have been anti-dilutive and, accordingly, the diluted (loss)/income per
share equals the basic (loss)/income per share for that period.
The number of such shares as of September 30, 2009 and 2008 subject to warrants was 8,701,401
and 1,964,644, respectively. The number of such shares as of September 30, 2009 and 2008 subject to
stock options was 3,127,566 and 4,389,985, respectively.
A reconciliation of the share data from a basic to a fully diluted basis is detailed below
(share data in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED SEPTEMBER 30, |
|
NINE MONTHS ENDED SEPTEMBER 30, |
|
|
2009 |
|
2008 |
|
2009 |
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic Shares |
|
|
90,303 |
|
|
|
89,250 |
|
|
|
90,209 |
|
|
|
89,169 |
|
Effect of Dilutive Securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants |
|
|
|
|
|
|
117 |
|
|
|
|
|
|
|
|
|
Options |
|
|
|
|
|
|
698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fully Diluted Shares |
|
|
90,303 |
|
|
|
90,065 |
|
|
|
90,209 |
|
|
|
89,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
Selected financial information by industry segment is presented below (in thousands).
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED SEPTEMBER 30, |
|
|
NINE MONTHS ENDED SEPTEMBER 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
REVENUES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
4,803 |
|
|
$ |
5,121 |
|
|
$ |
12,867 |
|
|
$ |
15,362 |
|
Hospital Drugs & Injectables |
|
|
3,220 |
|
|
|
6,293 |
|
|
|
11,054 |
|
|
|
16,226 |
|
Biologics & Vaccines |
|
|
9,421 |
|
|
|
17,879 |
|
|
|
27,950 |
|
|
|
29,698 |
|
Contract Services |
|
|
1,927 |
|
|
|
2,581 |
|
|
|
5,840 |
|
|
|
6,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
19,371 |
|
|
$ |
31,874 |
|
|
$ |
57,711 |
|
|
$ |
67,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GROSS PROFIT |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ophthalmic |
|
$ |
1,406 |
|
|
$ |
1,553 |
|
|
$ |
1,957 |
|
|
$ |
4,363 |
|
Hospital Drugs & Injectables |
|
|
39 |
|
|
|
2,384 |
|
|
|
1,149 |
|
|
|
4,813 |
|
Biologics & Vaccines |
|
|
1,041 |
|
|
|
5,290 |
|
|
|
6,073 |
|
|
|
7,444 |
|
Contract Services |
|
|
199 |
|
|
|
679 |
|
|
|
535 |
|
|
|
1,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total gross profit |
|
|
2,685 |
|
|
|
9,906 |
|
|
|
9,714 |
|
|
|
18,480 |
|
Operating expenses |
|
|
6,520 |
|
|
|
7,681 |
|
|
|
28,860 |
|
|
|
24,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(3,835 |
) |
|
|
2,225 |
|
|
|
(19,146 |
) |
|
|
(5,650 |
) |
Interest & other
(expense)/income |
|
|
(1,266 |
) |
|
|
176 |
|
|
|
(3,594 |
) |
|
|
(309 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)/ income before
income taxes |
|
$ |
(5,101 |
) |
|
$ |
2,401 |
|
|
$ |
(22,740 |
) |
|
$ |
(5,959 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
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 injectable radiation antidote products (DTPA) sold to the United States
Department of Health and Human Services 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) The Company has negotiated a payment deferral of $825,000 for product development
milestone fees with one of its development partners. The Company will pay these fees in June of
2010.
(iii) 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 (the L/C) by April 12, 2009 to secure its obligation to pay
amounts due to MBL, 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
15
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. The Company has made timely payments
on all Settlement Payments to date with $1,500,000 remaining as of September 30, 2009. This
$1,500,000 is due on June 30, 2010.
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 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 fair value of the Reimbursement
Warrant, using a Black-Scholes valuation model, is $1,382,000 at September 30, 2009.
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.
(iv) 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 the Companys 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.
(v) The Company manufactures and distributes finished drug products within the jurisdiction of
several regulatory authorities two of which are the FDA and the U.S. Drug Enforcement Agency. Failure to comply with respective regulatory criteria could result in material impact to
the Company (e.g. withholding of product approvals, interruption to operations, product recalls and
/ or seizure). To date, Akorn continues to operate within this jurisdiction, having undergone four
(4) inspections by the FDA during 2009 applicable to all three of Akorns sites. The Company
has responded to respective observations, with no subsequent comment
from the FDA. Akorn will
continue to work with the FDA to resolve any potential open questions, if / as they arise. No
adverse impact to the Company has occurred to date, from these inspections.
16
(vi) 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 customers accounted for 53% and 51%
of the Companys gross revenues and 43% and 40% of net revenues for the three months ended
September 30, 2009 and 2008, respectively. These three customers accounted for 60% and 58% of the
Companys gross revenues and 56% and 45% of net revenues for the nine months ended September 30,
2009 and 2008, respectively. They accounted for approximately 56% and 59% of the gross accounts
receivable balance as of September 30, 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 September 30, 2009, McKesson Medical Surgical (supplier for flu
vaccine) accounted for 29% of the Companys purchases. For the three months ended September 30,
2008, MBL (supplier for Td vaccine) and McKesson Medical Surgical (supplier for flu vaccine)
accounted for 52% and 16% of the Companys purchases, respectively. For the nine months ended
September 30, 2009, MBL (supplier for vaccine products) accounted for 42% of the Companys
purchases. For the nine months ended September 30, 2008, MBL and McKesson accounted for 55% and
11% of the Companys purchases, respectively.
The Company requires a supply of quality raw materials and components to manufacture and
package pharmaceutical products for its own use and for third parties with which it has contracted.
The principal components of the Companys products are active and inactive pharmaceutical
ingredients and certain packaging materials. Certain of these ingredients and components are
available from only a single source and, in the case of certain of the Companys Abbreviated New
Drug Applications and New Drug Applications (NDAs), only one supplier of raw materials has been
identified. Because FDA approval of drugs requires manufacturers to specify their proposed
suppliers of active ingredients and certain packaging materials in their applications, FDA approval
of any new supplier would be required if active ingredients or such packaging materials were no
longer available from the specified supplier. The qualification of a new supplier could delay the
Companys development and marketing efforts. If for any reason the Company is unable to obtain
sufficient quantities of any of the raw materials or components required to produce and package its
products, it may not be able to manufacture its products as planned, which could have a material
adverse effect on the Companys business, financial condition and results of operations.
NOTE N RECENT ACCOUNTING PRONOUNCEMENTS
On January 1, 2008, the Company adopted ASC 820 (formerly SFAS No. 157, Fair Value
Measurements). ASC 820 defines fair value, establishes a framework for measuring fair value, and
expands disclosures about fair value measurements. ASC 820 is effective for financial statements
issued for fiscal years beginning after November 15, 2007. In February of 2008, the FASB delayed
the effective date of ASC 820 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 the remaining provisions of ASC 820 effective January 1, 2009 and the
adoption did not have a material impact on the Companys results of operations or financial
position.
On January 1, 2009, the Company adopted ASC 810-10 (formerly SFAS No. 160, Non-Controlling
Interests in Consolidated Financial Statements an amendment of ARB No. 51). ASC 810-10 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. ASC
810-10 does not change the criteria for consolidating a partially owned entity. ASC 810-10 is
effective for fiscal years beginning after December 15, 2008. The adoption of ASC 810-10 did not
have a material impact on the Companys consolidated financial statements.
On January 1, 2009, the Company adopted ASC 805 (formerly SFAS 141R, Business Combinations).
ASC 805 establishes requirements for the recognition and measurement of acquired assets,
liabilities, goodwill, and non-controlling interests. ASC 805 also
17
provides disclosure requirements related to business combinations. ASC 805 is effective for
fiscal years beginning after December 15, 2008. ASC 805 will be applied prospectively to business
combinations with an acquisition date on or after the effective date.
On January 1, 2009, the Company adopted ASC 350-30-35 (formerly SFAS No. 142-3, Determination
of the Useful Life of Intangible Assets) , which 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 intangibles accounting. The intent of this update is to improve the
consistency between the useful life of a recognized intangible asset under prior business
combination accounting and the period of expected cash flows used to measure the fair value of the
asset under the new business combination accounting (as currently codified under ASC 850). ASC
350-30-35 is effective for financial statements issued for fiscal years beginning after December
15, 2008, and interim periods within those fiscal years. Early adoption is prohibited. The adoption
of ASC 350-30-35 did not have a material impact on the Companys financial statements.
During the second quarter of 2009, the Company adopted guidance issued by the FASB in April
2009 that requires entities to provide disclosure of the fair value of all financial instruments
within the scope of ASC 825, for which it is practicable to estimate that value, in interim
reporting periods as well as in annual financial statements. The Companys cash, accounts
receivable, accounts payable and debt obligations approximate fair value at September 30, 2009.
During the second quarter of 2009, the Company adopted ASC 855 (formerly SFAS No. 165,
Subsequent Events) which establishes general standards of accounting for and disclosure of events
that occur after the balance sheet date but before financial statements are issued for interim and
annual periods ending after June 15, 2009. The Company has considered the accounting and
disclosure of events occurring after the balance sheet date through the date and time the Companys
financial statements were issued on November 9, 2009. The adoption of this standard did not have
an impact on the Companys financial statements.
During the third quarter of 2009, the Company adopted ASC 105 (formerly SFAS No. 168, The
FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting
Principles) which has become the single source of authoritative nongovernmental U.S. GAAP. Rules
and interpretations of the SEC under authority of federal securities laws are also sources of
authoritative GAAP for SEC registrants. ASC 105 is effective for financial statements issued for
interim and annual periods ending after September 15, 2009. As ASC 105 does not change or alter
existing GAAP, it did not have any impact on the Companys financial statements.
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 September 30, 2009
included revenue of $3,771,000, gross profit of $1,325,000 and net income of $967,000. For the
nine months ended September 30, 2009, operating results included revenue of $6,534,000, gross
profit of $2,285,000 and net income of $1,343,000. Operating results for the three months ended
September 30, 2008 included revenue of $1,083,000, gross profit of $976,000 and net income of
$895,000. The Companys 50% share of the Joint Venture Company
net income was $484,000 and $672,000
for the three and nine month periods ended September 30, 2009, respectively, and $447,000 for the
three and nine months ended September 30, 2008, and is reflected as equity in earnings of unconsolidated joint
venture on the Companys statement of operations and statement of cash flows.
As of September 30, 2009 and December 31, 2008, the Joint Venture Company owed the Company
$311,000 and $210,000, respectively, related to sales and product distribution/fulfillment
functions.
NOTE P SEVERANCE CHARGES
During the second quarter of 2009, management restructured its operations resulting in the
elimination of approximately 25 positions as part of a broad cost reduction emphasis for the
Company. Severance charges of $493,000 were recorded for the quarter ended June 30, 2009 and were
primarily related to the elimination of operational and administrative positions and changes in the
senior executive
18
team. The charges were recorded in selling, general and administrative expenses on the statement of
operations. The remaining severance obligation at September 30, 2009 of $311,000 will be paid
during the fourth quarter of 2009 and during 2010.
NOTE Q SUBSEQUENT EVENTS
In October 2009, the Company offered a stock option exchange program for employees to voluntarily
exchange certain previously outstanding stock options for common shares of the Companys stock for
new stock options of the Companys common shares. The new stock options price will be the greater
of $1.34 per share or the closing price of the Companys common stock on November 19, 2009 which is
the date the option exchange program offer is set to expire. Employees may select to exchange all
their eligible stock option awards or only certain previous option awards that are eligible for
this exchange program. Vesting for the options which are exchanged will follow the same schedule
as had originally applied to those options, except that the vesting will restart based on the grant
date of the new option. All such exchanged options will expire on the fifth anniversary of the
grant date for the new stock options.
19
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:
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our ability to comply with all of the requirements of the U.S. Food and Drug
Administration (FDA), including current Good Manufacturing Practices regulations; |
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our ability to avoid defaults under debt covenants; |
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our ability to obtain regulatory approvals for products manufactured in our new
lyophilization facility; |
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our ability to generate cash from operations sufficient to meet our working capital
requirements; |
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our ability to obtain additional funding or financing to operate and grow our business; |
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the effects of federal, state and other governmental regulation on our business; |
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our success in developing, manufacturing, acquiring and marketing new products; |
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our ability to make timely payments to our Td vaccine supplier; |
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the success of our strategic partnerships for the development and marketing of new
products; |
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our ability to bring new products to market and the effects of sales of such products on
our financial results; |
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the effects of competition from generic pharmaceuticals and from other pharmaceutical
companies; |
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availability of raw materials needed to produce our products; and |
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other factors referred to in this Form 10-Q, our Form 10-K and our other SEC filings. |
20
RESULTS OF OPERATIONS
THREE MONTHS ENDED SEPTEMBER 30, 2009 COMPARED TO THREE MONTHS ENDED SEPTEMBER 30, 2008
The following table sets forth, for the periods indicated, revenues by segment, excluding
intersegment sales (in thousands):
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THREE MONTHS ENDED SEPTEMBER 30, |
|
|
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2009 |
|
|
2008 |
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Ophthalmic |
|
$ |
4,803 |
|
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$ |
5,121 |
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Hospital Drugs & Injectables |
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3,220 |
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|
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6,293 |
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Biologics & Vaccines |
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9,421 |
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|
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17,879 |
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Contract Services |
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1,927 |
|
|
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2,581 |
|
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|
|
|
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|
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Total revenues |
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$ |
19,371 |
|
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$ |
31,874 |
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|
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|
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Consolidated revenues decreased $12,503,000 or 39.2% in the quarter ended September 30, 2009
compared to the same period in 2008 mainly due to decreased sales of Td and flu vaccine and overall
lower sales to wholesalers as part of a targeted program to reduce
wholesalers inventory levels.
Ophthalmic revenues decreased by $318,000 or 6.2%, primarily due to targeted
wholesaler reductions in stocking levels. Hospital drugs and injectables revenues
decreased $3,073,000 or 48.8%, reflecting the targeted wholesaler reduction in stocking levels and
associated decreased sales volume of anesthesia and antidote products. Vaccine sales for the
quarter decreased by $8,458,000 versus the prior year period primarily due to the phase-out of our
Td vaccine products along with less availability of flu vaccine. Contract services revenues
decreased by $654,000 or 25.3%, mainly due to decreased order volumes on ophthalmic contract
products.
Consolidated gross profit was $2,685,000 or 13.9% of revenue for the third quarter of 2009 as
compared to a gross profit of $9,906,000 or 31.1% of revenue in the same period a year ago mainly
due to reduced hospital drug and injectable sales to wholesalers, higher purchase costs for our Td
vaccine product and a mix shift toward lower margin hospital drugs and injectables and contract
manufacturing products. We continue to seek margin enhancement opportunities through our product
offerings and efficiencies directed at reducing our product returns expense as well as efficiencies
and cost reductions in our operating facilities.
Selling, general and administrative (SG&A) expenses decreased by $1,012,000 or 16.3%, during
the quarter ended September 30, 2009 as compared to the same period in 2008. The decrease is mainly
due to cost reduction measures we implemented including personnel reductions and reduced travel
costs in the first nine months of 2009 and we continue to evaluate cost reduction opportunities.
Research and development (R&D) expense of $1,013,000 decreased by $130,000 or 11.4% in the
quarter from the level of $1,143,000 for the same period in 2008 mainly due to the timing of
product development milestone expenses.
Net
interest expense for the third quarter of 2009 was $441,000 compared
to $295,000 for the
same period in 2008. This increase is primarily due to interest on our subordinated note which was
issued in the third quarter of 2008. Also included in non-operating expenses for the third quarter
of 2009 was $187,000 for amortization of deferred finance costs related to the credit facility and
$1,122,000 for the change in the fair value of the warrants liability.
We reported a net loss of $5,101,000 for the three months ended September 30, 2009, compared
to a net profit of $2,401,000 for the same period in 2008 mainly due to the decreased sales volume
and gross profit along with higher net interest expense, the change in the warrants liability value
and other non-operating expenses partially offset by reduced SG&A and R&D expenses as discussed
above.
NINE MONTHS ENDED SEPTEMBER 30, 2009 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30, 2008
The following table sets forth, for the periods indicated, revenues by segment, excluding
intersegment sales (in thousands):
21
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NINE MONTHS ENDED SEPTEMBER 30 |
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|
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2009 |
|
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2008 |
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Ophthalmic |
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$ |
12,867 |
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$ |
15,362 |
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Hospital Drugs & Injectables |
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11,054 |
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16,226 |
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Biologics & Vaccines |
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27,950 |
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29,698 |
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Contract Services |
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5,840 |
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6,276 |
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Total revenues |
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$ |
57,711 |
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$ |
67,562 |
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Consolidated revenues decreased $9,851,000 or 14.6% for the nine months ended September 30,
2009 compared to the same period in 2008.
Ophthalmic revenues decreased $2,495,000 or 16.2%, primarily due to a provision of
$708,000 we recorded to recognize a significant return of our Akten® ophthalmic solution product
and also overall less favorable wholesaler returns experience. Akten® was launched in October 2008
and the significant returns were not previously anticipated as we had expected to capture
significant market share based on the products attributes. We have continued a trial sampling and
price reduction program which we began in the first half of 2009 to stimulate market demand for
this NDA product and do not expect additional significant returns of the product. Hospital Drugs &
Injectables revenues decreased by $5,172,000 or 31.9% mainly due to targeted wholesaler
stocking level reductions and decreased sales of anesthesia products. Biologics & Vaccines sales
decreased by $1,748,000 or 5.9% primarily due to lower flu vaccine sales in 2009. The loss of our
exclusivity with our Td vaccine supplier, as noted in our first quarter 2009 Form 10-Q, may
adversely impact our ability to maintain market share and generate future Td sales. Our contract
services revenues decreased by $436,000 or 6.9% mainly due to decreased order volumes on
ophthalmic contract products
Year-to-date consolidated gross profit was $9,714,000 or 16.8% of revenue for 2009 as compared
to a gross profit of $18,480,000 or 27.4% of revenue for the same period a year ago mainly due to
the variation in sales volume and product mix for each segment discussed above. We continue to seek
margin enhancement opportunities through our product offerings as well as through cost reductions
at our operating facilities.
SG&A expenses decreased by $354,000 or 1.9 % for the year to date period ended September 30,
2009 as compared to the same period in 2008. This is mainly due to personnel reductions and
targeted spending reductions, partially offset by severance costs in 2009.
In the first nine months of 2009, we recognized $5,929,000 in expense related to the
termination of our supply agreement with MBL which consisted of $4,750,000 in settlement payments,
$1,051,000 in costs for an associated letter of credit guarantee for the $10,500,000 in total
payments due MBL, and $128,000 in other related costs.
R&D expense decreased $1,063,000 or 22.4% for the nine months ended September 30, 2009, to
$3,681,000 from $4,744,000 for the same period in 2008 mainly due to reduced internal product
development activities and reduced product development milestone expenses with our strategic
business partners.
Net interest expense for the nine month period ended September 30, 2009 was $1,095,000 as
compared to $579,000 for the same period in 2008. This increase is primarily due to interest on
our subordinated note payable which was issued in the third quarter of 2008. Also included in
non-operating expenses for the nine month period ended September 30, 2009 was $1,739,000 for
amortization and write-offs of deferred financing fees related to the credit facility and
$1,432,000 for the change in the fair value of the warrants liability.
For the nine-month period ended September 30, 2009, the income tax provision was $2,000 as
compared to an income tax provision of $3,000 for the same period in 2008. These amounts reflect
minimum state income tax assessments as we incurred tax losses in both periods.
We reported a net loss of $22,742,000 for the nine months ended September 30, 2009, as
compared to a net loss of $5,962,000 for the same period in 2008 mainly due to lower gross profit
as a result of reduced overall sales, less favorable product mix and higher product returns
experience, $5,929,000 in expenses associated with the termination of our supply agreement with MBL
and $1,739,000 in amortization and write-offs of deferred finance costs, partially offset by lower
R&D expense as discussed above.
FINANCIAL CONDITION AND LIQUIDITY
Overview
During the nine-month period ended September 30, 2009, we used $5,349,000 in cash from
operations, primarily due to the $22,742,000 net loss, a $4,831,000 accounts receivable increase
due to the timing of sales and subsequent collections and a $4,337,000
22
decrease in accounts payable (primarily due to reduced Td vaccine payables), partially offset
by a $12,754,000 decrease in inventory as we reduced our stock of Td vaccines. In addition, we had
$1,739,000 in deferred financing fee write-offs along with non-cash depreciation, amortization,
stock compensation, supply agreement termination expense and change in fair value of the warrants
liability with these items totaling $8,276,000. Investing activities used $922,000 in cash mainly
due to capital expenditures for plant equipment. Financing activities provided $7,476,000 in cash
primarily due to the $7,509,000 in proceeds from our credit facility with EJ Funds and proceeds
from stock option exercises of $1,323,000, partially offset by $1,356,000 in loan origination fees
(see Credit Facility below).
During the nine-month period ended September 30, 2008, we used $14,295,000 in cash from
operations, primarily due to the $5,962,000 net loss, a $11,641,000 change in working capital items
mainly due to an increase in accounts receivable related to increased sales and reduced accounts
payable related to payments for vaccine inventory, partially offset by a reduction in vaccine
inventory and non-cash expenses of $3,322,000 for the period. Investing activities generated a
$2,668,000 reduction in cash flow mainly due to capital expenditures for production equipment and
our new warehouse/office facilities. Financing activities provided $9,105,000 in cash, primarily
due to the $5,727,000 in proceeds from our Credit Facility and $5,000,000 in proceeds from the
Subordinated Note issued to The John N. Kapoor Trust Dated September 20, 1989 (the Kapoor Trust)
in July 2008.
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
mortgage 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.
23
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 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 fair value of the Modification Warrant, using a
Black-Scholes valuation model, is $1,784,000 on September 30, 2009.
On August 17, 2009, we completed negotiations with EJ Funds for additional capacity on our
Credit Facility, increasing the loan commitment from $5,650,000 to $10,000,000. The Credit
Facility is secured by our assets and is not subject to debt covenants until April 1, 2010. In
connection with this loan commitment increase, we issued EJ Funds 1,650,806 warrants to purchase
our common stock at an exercise price of $1.16, the closing price of our stock on August 14, 2009.
The fair value of these warrants, using a Black-Scholes valuation model, was $1,238,000 on August
17, 2009, and this amount was capitalized as financing costs and is being amortized over the
remaining term of the Credit Facility.
Subordinated Debt
On July 28, 2008, we borrowed $5,000,000 from the Kapoor Trust in return for issuing the trust
the Subordinated Note. The Subordinated Note accrues interest at a rate of 15% per year and was
due and payable on July 28, 2009. The proceeds from the Subordinated Note were used in conjunction
with the July 2008 amended MBL Distribution Agreement, which resulted in favorable pricing and
reduced purchase commitments (see Note L Commitments and Contingencies).
On August 17, 2009, we refinanced the $5,000,000 subordinated debt payable to the Kapoor
Trust. The principal amount of $5,000,000 has been increased to $5,853,267 to include accrued
interest through August 16, 2009 (interest accruing thereafter is payable monthly) and the annual
interest rate of 15% remained unchanged. The term of the Subordinated Note has been extended by an
24
additional five years and is now due and payable on August 17, 2014. As part of this refinancing
agreement, we issued the Kapoor Trust
an additional 2,099,935 warrants to purchase our common stock at an exercise price of $1.16,
the closing price of our stock on August 14, 2009. The fair value of these warrants on August 17,
2009, using a Black-Scholes valuation model, was $1,575,000 and this amount was capitalized as
financing costs and is being amortized over the term of the subordinated debt.
Series B Warrants
On August 23, 2004, in connection with an issuance of preferred stock to certain investors, we
issued warrants to purchase 1,566,667 shares of common stock exercisable until August 23, 2009,
with an exercise price of $3.50 per share (the Series B Warrants). There were 455,556 Series B
Warrants outstanding on August 23, 2009 and the book value of
these warrants was reclassified to
Common Stock on our financial statements as the warrants expired
unexercised.
CONTRACTUAL OBLIGATIONS
In July 2008, we amended our Exclusive Distribution Agreement with the Massachusetts Biologic
Laboratories of the University of Massachusetts Medical School (MBL) dated as of March 22, 2007
(the MBL Distribution Agreement) to: (i) allow us to destroy our remaining inventory of Tetanus
Diphtheria (Td) 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 provide MBL with a standby letter of credit (the L/C) to secure
our obligation to pay amounts due to MBL, 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. To date we have made timely payments for the Settlement Payments due MBL and the final
remaining payment of $1,500,000 is due on June 30, 2010.
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.
25
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 $1,382,000 at September 30, 2009.
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.
RECENT ACCOUNTING PRONOUNCEMENTS
On January 1, 2008, we adopted Accounting Standards Codification (ASC) 820 (formerly SFAS
No. 157, Fair Value Measurements). ASC 820 defines fair value, establishes a framework for
measuring fair value, and expands disclosures about fair value measurements. ASC 820 is effective
for financial statements issued for fiscal years beginning after November 15, 2007. In February of
2008, the FASB delayed the effective date of ASC 820 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 the remaining provisions of ASC 820 effective
January 1, 2009 and the adoption did not have a material impact on our results of operations or
financial position.
On January 1, 2009, we adopted ASC 810-10 (formerly SFAS No. 160, Non-Controlling Interests in
Consolidated Financial Statements an amendment of ARB No. 51). ASC 810-10 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. ASC
810-10 does not change the criteria for consolidating a partially owned entity. ASC 810-10 is
effective for fiscal years beginning after December 15, 2008. The adoption of ASC 810-10 did not
have a material impact on our consolidated financial statements.
On January 1, 2009, we adopted ASC 805 (formerly SFAS 141R, Business Combinations). ASC 805
establishes requirements for the recognition and measurement of acquired assets, liabilities,
goodwill, and non-controlling interests. ASC 805 also provides disclosure requirements related to
business combinations. ASC 805 is effective for fiscal years beginning after December 15, 2008.
ASC 805 will be applied prospectively to business combinations with an acquisition date on or after
the effective date.
On January 1, 2009, we adopted ASC 350-30-35 (formerly SFAS No. 142-3, Determination of the
Useful Life of Intangible Assets) , which 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 intangibles accounting. The intent of this update is to improve the
consistency between the useful life
26
of a recognized intangible asset under prior business
combination accounting and the period of expected cash flows used to measure the
fair value of the asset under the new business combination accounting (as currently codified
under ASC 850). ASC 350-30-35 is effective for financial statements issued for fiscal years
beginning after December 15, 2008, and interim periods within those fiscal years. Early adoption is
prohibited. The adoption of ASC 350-30-35 did not have a material impact on our financial
statements.
During the second quarter of 2009, we adopted guidance issued by the FASB in April 2009 that
requires entities to provide disclosure of the fair value of all financial instruments within the
scope of ASC 825, for which it is practicable to estimate that value, in interim reporting periods
as well as in annual financial statements. Our cash, accounts receivable, accounts payable and
debt obligations approximate fair value at September 30, 2009.
During the second quarter of 2009, we adopted ASC 855 (formerly SFAS No. 165, Subsequent
Events) which establishes general standards of accounting for and disclosure of events that occur
after the balance sheet date but before financial statements are issued for interim and annual
periods ending after June 15, 2009. We have considered the accounting and disclosure of events
occurring after the balance sheet date through the date and time our financial statements were
issued on November 9, 2009. The adoption of this standard did not have an impact on our financial
statements.
During the third quarter of 2009, we adopted ASC 105 (formerly SFAS No. 168, The FASB
Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles)
which has become the single source of authoritative nongovernmental U.S. GAAP. Rules and
interpretations of the SEC under authority of federal securities laws are also sources of
authoritative GAAP for SEC registrants. ASC 105 is effective for financial statements issued for
interim and annual periods ending after September 15, 2009. As ASC 105 does not change or alter
existing GAAP, it did not have any impact on our 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 fair value of the debt obligations approximated their recorded values as of September 30,
2009.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
An evaluation was performed, under the supervision and with the participation of our
management, including the Interim Chief Executive Officer (CEO) and Chief Financial Officer
(CFO), of the effectiveness of the design and operation of our 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 September 30, 2009, our disclosure controls and
procedures were
27
effective in all material respects at the reasonable assurance level to ensure that
information required to be disclosed in reports that we file or submit 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 September 30, 2009, there was 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.
28
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 had 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 informed Mr. Przybyl of 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 the discovery stage.
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 September 30, 2009, we are aware of the sale of 20,554,359 shares of common stock by
selling
29
stockholders under the S-3 or the S-1. We do not know at what price such shares were sold, or
how many shares of common stock will be sold in the future or at what price. We have not and will
not receive any of the proceeds from the sale of the shares by the selling stockholders. The
selling stockholders will receive all of the proceeds from the sale of the shares and will pay all
underwriting discounts and selling commissions, if any, applicable to the sale of the shares. We
will, in the ordinary course of business, receive proceeds from the issuance of shares upon
exercise of the warrants described in the S-3 or the S-1, which we will use for working capital and
other general corporate purposes.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Our 2009 annual meeting of shareholders was held on August 7, 2009. At that meeting, the
following proposals were approved:
1. The election of the following eight directors to our Board of Directors:
|
|
|
|
|
|
|
|
|
Nominee |
|
Votes For |
|
Votes Withheld |
John N. Kapoor, Ph.D. |
|
|
48,868,056 |
|
|
|
231,478 |
|
Jerry N. Ellis |
|
|
46,735,387 |
|
|
|
2,364,147 |
|
Ronald M. Johnson |
|
|
46,739,320 |
|
|
|
2,360,214 |
|
Subhash Kapre, Ph.D. |
|
|
41,451,341 |
|
|
|
7,648,193 |
|
Brian Tambi |
|
|
48,886,720 |
|
|
|
212,814 |
|
Steven J. Meyer |
|
|
48,887,111 |
|
|
|
212,423 |
|
Alan Weinstein |
|
|
48,887,178 |
|
|
|
212,356 |
|
Randall J. Wall |
|
|
48,887,428 |
|
|
|
212,106 |
|
2. The ratification of the selection by the Audit Committee of the Board of Directors of Ernst &
Young LLP as our independent registered public accounting firm for the fiscal year ending December
31, 2009. A total of 49,079,142 votes were cast in favor of this proposal, 18,189 votes were cast
against, and there were 2,203 abstentions.
3. The amendment of the Amended and Restated Akorn, Inc. 2003 Stock Option Plan to increase the
total number of shares authorized and reserved for issuance by 6,000,000 shares. A total of
35,961,785 votes were cast in favor of this proposal, 13,120,204 votes were cast against, and there
were 17,545 abstentions.
4. The amendment of the Amended and Restated Akorn, Inc. Employee Stock Purchase Plan to increase
the total number of shares authorized and reserved for issuance by 1,000,000 shares. A total of
48,657,066 votes were cast in favor of this proposal, 426,773 votes were cast against, and there
were 15,695 abstentions.
ITEM 5. OTHER INFORMATION
None.
30
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.
|
|
|
Exhibit |
|
|
No. |
|
Description |
(4.1)
|
|
Common Stock Purchase Warrant dated August 17, 2009, in favor of EJ Funds LP.
(Incorporated by reference to Exhibit 10.2 of a Form 8-K filed on August 21, 2009.) |
|
|
|
(4.2)
|
|
Common Stock Purchase Warrant dated August 17, 2009, in favor of John N. Kapoor Trust
Dated 9/20/89. (Incorporated by reference to Exhibit 10.4 of a Form 8-K filed on
August 21, 2009.) |
|
|
|
(10.1)
|
|
Amended and Restated Credit Agreement dated August 17, 2009, by and among the
Company, Akorn (New Jersey), Inc., a wholly owned subsidiary of the Company, other
persons party thereto that are designated as credit parties, EJ Funds LP, and the
other financial institution from time to time party thereto. (Incorporated by
reference to Exhibit 10.1 of a Form 8-K filed on August 21, 2009.) |
|
|
|
(10.2)
|
|
Amended and Restated Subordinated Note dated August 17, 2009, made by the Company and
Akorn (New Jersey), Inc., in favor of John N. Kapoor Trust Dated 9/20/89.
(Incorporated by reference to Exhibit 10.3 of a Form 8-K filed on August 21, 2009.) |
|
|
|
(10.3)
|
|
Registration Rights Agreement made and entered into as of August 17, 2009 by and
among the Company, John N. Kapoor Trust Dated 9/20/89 and EJ Funds LP. (Incorporated
by reference to Exhibit 10.5 of a Form 8-K filed on August 21, 2009.) |
|
|
|
(10.4)
|
|
Amended and Restated Subordination Agreement dated as of August 17, 2009 by and among
John N. Kapoor Trust Dated 9/20/89, the Company, Akorn (New Jersey), Inc. and EJ
FUNDS LP. (Incorporated by reference to Exhibit 10.6 of a Form 8-K filed on August
21, 2009.) |
|
|
|
(31.1)*
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a). |
|
|
|
(31.2)*
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a). |
|
|
|
(32.1)*
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. § 1350. |
|
|
|
(32.2)*
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. § 1350. |
31
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.
|
|
|
|
|
|
AKORN, INC.
|
|
|
/s/ Timothy A. Dick
|
|
|
Timothy A. Dick |
|
|
Sr. Vice President, Chief Financial Officer
(Duly Authorized and Principal Financial Officer) |
|
|
Date: November 9, 2009
32