e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
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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, 2008
OR
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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: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
(State or other jurisdiction
of incorporation or organization)
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33-0476164
(I.R.S. Employer of
Identification No.) |
3260 Whipple Road
Union City, CA 94587-1217
(Address of Principal Executive Offices)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 400-0700
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 prior that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer þ (Do not check if a smaller reporting company) | Smaller reporting company o |
Indicate by check mark whether Registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
As of October 31, 2008 there were 64,954,004 shares of the Registrants common stock, no par
value per share, outstanding.
QUESTCOR PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
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September 30, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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(Note 1) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
12,006 |
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$ |
15,939 |
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Short-term investments |
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28,913 |
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14,273 |
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Total cash, cash equivalents and short-term investments |
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40,919 |
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30,212 |
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Accounts receivable, net of allowance for doubtful accounts of
$119 and $57 at September 30, 2008
and December 31, 2007, respectively |
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11,106 |
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23,639 |
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Inventories, net |
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2,437 |
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2,365 |
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Prepaid expenses and other current assets |
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1,267 |
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778 |
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Deferred tax assets |
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7,849 |
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14,879 |
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Total current assets |
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63,578 |
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71,873 |
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Property and equipment, net |
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426 |
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522 |
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Purchased technology, net |
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3,744 |
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3,967 |
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Goodwill |
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299 |
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299 |
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Deposits and other assets |
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709 |
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744 |
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Deferred tax assets, net |
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1,043 |
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1,043 |
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Total assets |
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$ |
69,799 |
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$ |
78,448 |
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LIABILITIES, PREFERRED STOCK AND SHAREHOLDERS
EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
4,544 |
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$ |
1,777 |
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Accrued compensation |
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1,393 |
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1,945 |
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Sales-related reserves |
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13,975 |
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8,176 |
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Income taxes payable |
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1,330 |
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Other accrued liabilities |
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1,743 |
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1,492 |
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Total current liabilities |
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21,655 |
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14,720 |
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Lease termination and deferred rent liabilities and other non-current
liabilities |
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1,610 |
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1,876 |
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Preferred stock, no par value, 7,500,000 shares authorized; none and
2,155,715 Series A shares issued and outstanding at September 30, 2008 and
December 31, 2007, respectively (aggregate liquidation preference of $10,000 at
December 31, 2007)
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5,081 |
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Shareholders equity: |
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Common stock, no par value, 105,000,000 shares authorized;
64,954,004 and 70,118,166 shares issued and outstanding at September 30, 2008
and December 31, 2007, respectively |
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79,186 |
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108,387 |
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Accumulated deficit |
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(32,647 |
) |
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(51,670 |
) |
Accumulated other comprehensive gain (loss) |
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(5 |
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54 |
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Total shareholders equity |
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46,534 |
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56,771 |
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Total liabilities, preferred stock and shareholders equity |
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$ |
69,799 |
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$ |
78,448 |
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See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(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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2008 |
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2007 |
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2008 |
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2007 |
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Net sales |
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$ |
24,200 |
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$ |
14,809 |
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$ |
68,230 |
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$ |
22,654 |
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Cost of sales (exclusive of amortization of purchased technology) |
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1,937 |
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1,534 |
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5,446 |
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3,298 |
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Gross profit |
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22,263 |
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13,275 |
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62,784 |
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19,356 |
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Operating costs and expenses: |
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Selling, general and administrative |
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4,251 |
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3,322 |
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14,172 |
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13,619 |
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Research and development |
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2,577 |
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1,264 |
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8,103 |
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3,355 |
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Depreciation and amortization |
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134 |
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125 |
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379 |
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373 |
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Total operating costs and expenses |
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6,962 |
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4,711 |
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22,654 |
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17,347 |
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Income from operations |
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15,301 |
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8,564 |
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40,130 |
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2,009 |
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Other income (expense): |
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Interest income |
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209 |
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164 |
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817 |
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|
555 |
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Other income (expense), net |
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(1 |
) |
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11 |
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|
239 |
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Gain on sale of product rights |
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|
448 |
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Total other income |
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209 |
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163 |
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828 |
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1,242 |
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Income before income taxes |
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15,510 |
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8,727 |
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40,958 |
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3,251 |
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Income tax expense |
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6,555 |
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|
102 |
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16,668 |
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102 |
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Net income |
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8,955 |
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8,625 |
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24,290 |
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3,149 |
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Deemed dividend on Series A preferred stock |
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5,267 |
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Allocation of undistributed earnings to Series A preferred stock |
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261 |
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95 |
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Net income applicable to common shareholders |
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$ |
8,955 |
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$ |
8,364 |
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$ |
19,023 |
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$ |
3,054 |
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Net income per share applicable to common shareholders: |
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Basic |
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$ |
0.13 |
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$ |
0.12 |
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$ |
0.28 |
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$ |
0.04 |
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Diluted |
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$ |
0.13 |
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$ |
0.12 |
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$ |
0.26 |
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$ |
0.04 |
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Shares used in computing net income per share applicable to common
shareholders: |
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Basic |
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66,796 |
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69,192 |
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68,642 |
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68,986 |
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Diluted |
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|
70,111 |
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|
69,224 |
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72,360 |
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69,985 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Nine Months Ended |
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September 30, |
|
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2008 |
|
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2007 |
|
OPERATING ACTIVITIES |
|
|
|
|
|
|
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Net income |
|
$ |
24,290 |
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|
$ |
3,149 |
|
Adjustments to reconcile net income to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
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|
Share-based compensation expense |
|
|
3,773 |
|
|
|
1,025 |
|
Deferred income taxes |
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|
8,504 |
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|
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|
Amortization of investments |
|
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(421 |
) |
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Depreciation and amortization |
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|
368 |
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|
373 |
|
Loss on disposal of equipment |
|
|
10 |
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|
12 |
|
Gain on sale of product rights |
|
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|
|
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|
(448 |
) |
Excess tax benefit from share-based compensation |
|
|
(1,424 |
) |
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|
Changes in operating assets and liabilities: |
|
|
|
|
|
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Accounts receivable |
|
|
12,533 |
|
|
|
(12,366 |
) |
Inventories |
|
|
(72 |
) |
|
|
397 |
|
Prepaid expenses and other current assets |
|
|
(489 |
) |
|
|
183 |
|
Accounts payable |
|
|
2,767 |
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|
|
(228 |
) |
Accrued compensation |
|
|
(552 |
) |
|
|
(303 |
) |
Sales-related reserves |
|
|
5,799 |
|
|
|
(643 |
) |
Income taxes payable |
|
|
(1,330 |
) |
|
|
102 |
|
Other accrued liabilities |
|
|
251 |
|
|
|
325 |
|
Other non-current liabilities |
|
|
(266 |
) |
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|
58 |
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Net cash flows provided by (used in) operating activities |
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|
53,741 |
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(8,364 |
) |
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INVESTING ACTIVITIES |
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Purchase of property and equipment |
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(59 |
) |
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(67 |
) |
Acquisition of purchased technology |
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(300 |
) |
Purchase of short-term investments |
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(45,664 |
) |
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(17,188 |
) |
Proceeds from the sale and maturities of short-term investments |
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|
31,386 |
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|
12,250 |
|
Net proceeds from sale of product rights |
|
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|
|
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|
448 |
|
Changes in deposits and other assets |
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|
35 |
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|
(16 |
) |
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Net cash flows used in investing activities |
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|
(14,302 |
) |
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|
(4,873 |
) |
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FINANCING ACTIVITIES |
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Issuance of common stock, net |
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|
1,123 |
|
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|
449 |
|
Repurchase of Series A preferred stock |
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|
(10,348 |
) |
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Repurchase of common stock |
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|
(35,571 |
) |
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Excess tax benefit from share-based compensation |
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|
1,424 |
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|
|
|
|
|
|
|
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Net cash flows provided by (used in) financing activities |
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|
(43,372 |
) |
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|
449 |
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|
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Decrease in cash and cash equivalents |
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|
(3,933 |
) |
|
|
(12,788 |
) |
Cash and cash equivalents at beginning of period |
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|
15,939 |
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|
|
15,937 |
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|
|
|
|
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|
Cash and cash equivalents at end of period |
|
$ |
12,006 |
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|
$ |
3,149 |
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|
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. ORGANIZATION AND BASIS OF PRESENTATION
Organization
Questcor Pharmaceuticals, Inc. (the Company or Questcor) is a pharmaceutical company that
markets two commercial products, H.P. Acthar® Gel (repository corticotropin injection) and Doral®
(quazepam). H.P. Acthar Gel (Acthar) is an injectable drug that is approved for the treatment of
certain disorders with an inflammatory component, including the treatment of exacerbations
associated with multiple sclerosis (MS), and the treatment of Nephrotic Syndrome. In addition,
Acthar is not indicated for, but is used in treating patients with infantile spasms (IS), a rare
form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related
childhood neurological disorder. Doral is indicated for the treatment of insomnia characterized by
difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. The
Company is also developing QSC-001, a unique orally disintegrating tablet formulation of
hydrocodone bitartrate and acetaminophen for the treatment of moderate to moderately severe pain in
patients with swallowing difficulties.
In August 2007, the Company announced its Acthar-centric business strategy. As part of the new
strategy, the Company implemented a new pricing level for Acthar which took effect August 27, 2007.
The Company also expanded its sponsorship of Acthar patient assistance and co-pay assistance
programs, which provide an important safety net for uninsured and under-insured patients using
Acthar, and established a group of product service consultants and medical science liaisons to work
with healthcare providers who administer Acthar.
Basis of Presentation
The Company has determined that it operates in one business segment, pharmaceutical products.
The accompanying unaudited consolidated financial statements of the Company have been prepared in
accordance with U.S. generally accepted accounting principles and applicable Securities and
Exchange Commission regulations for interim financial information. These financial statements do
not include all of the information and footnotes required by U.S. generally accepted accounting
principles for complete financial statements. The unaudited financial statements should be read in
conjunction with the audited financial statements and related footnotes included in the Companys
Annual Report on Form 10-K for the year ended December 31, 2007. The accompanying consolidated
balance sheet at December 31, 2007 has been derived from the audited financial statements at that
date. In the opinion of the Companys management, all adjustments (consisting of normal recurring
adjustments) considered necessary for the fair presentation of interim financial information have
been included. Operating results for the interim period presented are not necessarily indicative of
the results that may be expected for the year ending December 31, 2008 or for any future interim
period. The consolidated financial statements include the accounts of the Company and its wholly
owned subsidiary. All significant intercompany accounts and transactions have been eliminated. The
preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions that affect the amounts reported
in the financial statements and disclosures made in the accompanying notes to the financial
statements. Actual results could differ from those estimates.
2. SHARE-BASED COMPENSATION
Effective January 1, 2006, the Company adopted the fair value recognition provisions of
Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based Payment
(SFAS No. 123(R)), using the modified-prospective transition method. Under that transition
method, share-based compensation cost related to employees and non-employee members of the
Companys board of directors includes the compensation cost related to share-based payments granted
to employees and non-employee members of the board of directors through, but not yet vested as of
December 31, 2005, based on the grant-date fair value estimated in accordance with the provisions
of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS No. 123), and compensation cost
for share-based payments granted to employees and non-employee members of the board of directors
subsequent to December 31, 2005, based on the grant-date fair value estimated in accordance with
the provisions of SFAS No. 123(R).
6
Share-based compensation expense recorded for awards granted to employees and non-employee
members of the board of directors under stock option plans and the employee stock purchase plan is
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Cost of sales |
|
$ |
|
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
3 |
|
Selling, general and administrative |
|
|
493 |
|
|
|
162 |
|
|
|
2,998 |
|
|
|
859 |
|
Research and development |
|
|
142 |
|
|
|
60 |
|
|
|
660 |
|
|
|
189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
635 |
|
|
$ |
223 |
|
|
$ |
3,658 |
|
|
$ |
1,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation cost related to stock options granted to employees and non-employee
members of the board of directors is recognized as an expense, net of estimated pre-vesting
forfeitures, ratably over the vesting period of the award. The Company has estimated an annual
pre-vesting forfeiture rate of 12% for a typical stock award with a four year vesting term. The
pre-vesting forfeiture rate was estimated based on historical data.
The fair value of stock options awarded to employees and non-employee members of the Companys
board of directors was estimated using the Black-Scholes option valuation model. Expected
volatility is based on the historical volatility of the Companys stock. The expected term for the
three and nine month periods ended September 30, 2008 is based on the Companys historical term of
its stock option awards. The expected term for the three and nine month periods ended September 30,
2007 was estimated using the simplified method described in Staff Accounting Bulletin No. 107
issued by the Securities and Exchange Commission. The expected term represents the estimated period
of time that stock options granted are expected to be outstanding. The risk-free interest rate is
based on the U.S. Treasury yield curve. The expected dividend yield is zero, as the Company does
not anticipate paying dividends in the near future. The weighted average assumptions are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Expected volatility |
|
|
86 |
% |
|
|
82 |
% |
|
|
86 |
% |
|
|
82-86 |
% |
Weighted average volatility |
|
|
86 |
% |
|
|
82 |
% |
|
|
86 |
% |
|
|
85 |
% |
Expected term (in years) |
|
|
4.4 |
|
|
|
6.25 |
|
|
|
4.4 |
|
|
|
6.25 |
|
Risk-free interest rate |
|
|
2.6 |
% |
|
|
4.3 |
% |
|
|
2.1-3.2 |
% |
|
|
4.3-4.9 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of the stock options granted to employees and
non-employee members of the Companys board of directors was $3.36 and $0.34 during the three month
periods ended September 30, 2008 and 2007, respectively, and $3.36 and $0.81 during the nine month
periods ended September 30, 2008 and 2007, respectively.
The Company utilized the Black-Scholes option valuation model in connection with determining
the fair value of each option element of the Companys Employee Stock Purchase Plan. Expected
volatility is based on historical volatility of the Companys common stock. The expected term
represents the life of the option element. The risk-free interest rate is based on the U.S.
Treasury yield. The expected dividend yield is zero, as the Company does not anticipate paying
dividends in the near future. The weighted average assumptions are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Expected volatility |
|
|
79 |
% |
|
|
76 |
% |
|
|
78-81 |
% |
|
|
65-76 |
% |
Weighted average volatility |
|
|
79 |
% |
|
|
76 |
% |
|
|
79 |
% |
|
|
68 |
% |
Expected term (in years) |
|
|
0.74 |
|
|
|
1.00 |
|
|
|
0.30-0.74 |
|
|
|
0.53-1.00 |
|
Risk-free interest rate |
|
|
2.5 |
% |
|
|
4.9 |
% |
|
|
2.4 |
% |
|
|
5.0 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value of each option element under the Companys Employee Stock
Purchase Plan was $3.45 and $0.52 for the three month periods ended September 30, 2008 and 2007,
respectively, and $3.58 and $0.44 for the nine month periods ended September 30, 2008 and 2007,
respectively.
7
3. REVENUE RECOGNITION
During July 2007, the Company began utilizing CuraScript, a third party specialty distributor,
to store and distribute Acthar. Effective August 1, 2007, the Company no longer sells Acthar to
wholesalers and all of the Companys proceeds from sales of Acthar in the United States are
received from CuraScript. The Company sells Acthar to CuraScript at a discount from the Companys
list price. CuraScript sells Acthar primarily to hospitals and specialty pharmacies. Product sales
are recognized net of this discount upon receipt of the product by CuraScript. In April 2008, the
Company revised its agreement with CuraScript, as discussed further in Note 13. The Company sells
Doral to wholesalers, who in turn sell Doral primarily to retail pharmacies and hospitals. The
Company does not require collateral from its customers. Revenues from product sales are recognized
based upon shipping terms, net of estimated reserves for government chargebacks, Medicaid rebates,
payment discounts and returns for credit. Revenue is recognized upon customer receipt of the
shipment, provided that title to the product transfers at the point of receipt by the customer. If
the title to the product transfers at the point of shipment, revenue is recognized upon shipment of
the product.
The Company will supply replacement product to CuraScript on product returned between one
month prior to expiration to three months post expiration. Returns from product lots will be
exchanged for replacement product, and estimated costs for such exchanges, which include actual
product material costs and related shipping charges, are included in cost of sales. A reserve for
estimated future replacements has been recorded as a liability within sales-related reserves which
will be reduced as future replacements occur, with an offset to product inventories.
For Doral, and for Acthar sold prior to July 2007, the Company issues credit memoranda or
reimburses wholesalers or their customers for product sold to the wholesaler that is returned
within six months beyond the expiration date. The credit memoranda or reimbursement is equal to the
sales value of the product returned and the estimated amount of such obligation is recorded as a
liability within sales-related reserves with a corresponding reduction in gross product sales. This
liability is reduced as the obligation is satisfied, with an offset to accounts receivable. Returns
are subject to inspection prior to acceptance. The Company records estimated sales reserves based
primarily upon historical return rates by product, analysis of return merchandise authorizations
and returns received. The Company also considers sales patterns, current inventory on hand at
wholesalers, and other factors such as shelf life.
The Company provides a rebate related to product dispensed to Medicaid eligible patients. The
Companys a) estimated historical rebate percentage, adjusted for b) recent and expected future
utilization rates for these programs, is used to estimate the rebate units associated with product
shipped during a period as follows:
|
a) |
|
The estimated historic liability included in sales-related reserves as of the end of a
period is comprised of the estimated rebate units associated with estimated end user demand
during the period, the estimated rebate units associated with estimated inventory in the
distribution channel as of the end of the period, and the estimated rebate units, if any,
associated with prior rebate periods. |
|
|
b) |
|
In order to assess current and future rates of Medicaid
utilization, the Company analyzes inventory levels and patient prescription data received from a
third party, CuraScript. |
The rebate amount per unit is determined based on a formula established by statute that is
subject to review and modification by the administrators of the Medicaid program. The rebate per
unit formula is comprised of a basic rebate of 15.1% applied to the average per unit amount of
payments the Company receives on its product sales and an additional per unit rebate that is based
on the Companys current sales price compared to its sales price on an inflation adjusted basis
from a designated base period. The Company multiplies the rebate amount per unit by the
estimated rebate units to arrive at the estimated reserve for the period. This estimated reserve is
deducted from gross sales in the determination of net sales. Effective January 1, 2008, the amount
the Company rebates for each Acthar vial dispensed to a Medicaid eligible patient is approximately
$2,500 higher
than the price to CuraScript.
Certain government-supported entities are permitted to purchase the Companys products for a
nominal amount from wholesalers and CuraScript. The wholesalers and CuraScript charge the
significant discount back to the Company and reduce subsequent payment to the Company by the amount
of the approved chargeback. The chargeback approximates the Companys sales price to its customers.
As a result, the Company recognizes nominal, if any, net sales on shipments that qualify for the
government chargeback. The reduction to gross sales for a period related to chargebacks is
comprised of actual approved chargebacks originating during the period
8
and an estimate of chargebacks in the ending inventory of the Companys customers. In estimating
the government chargeback reserve as of the end of a period, the Company estimates the amount of
chargebacks in its customers ending inventory using actual average monthly chargeback amounts and
ending inventory balances provided by the Companys largest customers.
Significant judgment is inherent in the selection of assumptions and in the interpretation of
historical experience as well as the identification of external and internal factors affecting the
estimate of reserves for product returns, Medicaid rebates and government chargebacks. The Company
routinely assesses the historical returns and other experience including customers compliance with
its return goods policy and changes its reserve estimates as appropriate. During the third quarter
of 2008, based on higher rebate usage reflected in the prescription data provided by CuraScript,
the Company revised its estimate for Medicaid rebates. The effect of this revision was to reduce
net sales by $1.4 million, and decrease net income per share by approximately $0.01 for the three
and nine month periods ended September 30, 2008.
At September 30, 2008 and December 31, 2007, sales-related reserves included in the
accompanying Consolidated Balance Sheets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Medicaid rebates |
|
$ |
13,478 |
|
|
$ |
6,514 |
|
Government chargebacks |
|
|
58 |
|
|
|
222 |
|
Product returns credit memoranda policy |
|
|
391 |
|
|
|
1,307 |
|
Product returns product replacement policy |
|
|
48 |
|
|
|
31 |
|
Other |
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
$ |
13,975 |
|
|
$ |
8,176 |
|
|
|
|
|
|
|
|
4. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
The Company considers highly liquid investments with maturities from the date of purchase of
three months or less to be cash equivalents. The Company had cash, cash equivalents and short-term
investments of $40.9 million and $30.2 million at September 30, 2008 and December 31, 2007,
respectively. Cash equivalents are invested in money market funds. Short-term investments are
invested in commercial paper and government-sponsored enterprises and have an average contractual
maturity of approximately 7 months as of September 30, 2008. The fair value of the funds
approximated their cost.
Effective January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements (SFAS
No. 157). SFAS No. 157 applies to all fair value measurements not otherwise specified in an existing
standard, clarifies how to measure fair value, and expands fair value disclosures. SFAS No. 157
does not significantly change the Companys previous practice with regard to asset valuation. The
Companys fair market value measurements utilize either quoted prices in active markets or prices
using a readily observable input for all its short-term investments, and are as a result valued at
either the Level 1 or Level 2 fair value hierarchy, respectively, as defined in SFAS No. 157.
The following table summarizes the basis used to measure certain assets at fair value on a
recurring basis in the accompanying Consolidated Balance Sheet at September 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basis of Fair Value Measurements |
|
|
|
|
|
|
|
Quoted prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
in active |
|
|
other |
|
|
Significant |
|
|
|
Balance at |
|
|
markets for |
|
|
observable |
|
|
unobservable |
|
|
|
September 30, |
|
|
identical items |
|
|
inputs |
|
|
inputs |
|
|
|
2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Money market funds |
|
$ |
8,408 |
|
|
$ |
8,408 |
|
|
$ |
|
|
|
|
|
|
Commercial paper |
|
|
6,482 |
|
|
|
|
|
|
|
6,482 |
|
|
|
|
|
Government-sponsored enterprises |
|
|
22,431 |
|
|
|
|
|
|
|
22,431 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
37,321 |
|
|
$ |
8,408 |
|
|
$ |
28,913 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist
of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
1,996 |
|
|
$ |
1,987 |
|
Finished goods |
|
|
457 |
|
|
|
387 |
|
Less allowance for excess and obsolete inventories |
|
|
(16 |
) |
|
|
(9 |
) |
|
|
|
|
|
|
|
|
|
$ |
2,437 |
|
|
$ |
2,365 |
|
|
|
|
|
|
|
|
6. PURCHASED TECHNOLOGY
Purchased technology at September 30, 2008 consists of the Companys acquisition costs related
to the May 2006 acquisition of the Doral product rights and a cash payment of $300,000 to IVAX
Research, Inc. made in January 2007 to eliminate the Doral royalty obligation. The purchased
technology is being amortized on a straight-line basis over Dorals expected life of 15 years.
Accumulated amortization for the Doral purchased technology was $642,000 as of September 30, 2008.
7. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
The Company leases a 30,000 square foot facility in Hayward, California. The Companys master
lease on the Hayward facility expires in November 2012. Effective November 1, 2007, the Company
subleased 5,000 square feet of the facility through April 2009 and effective February 1, 2008 the
Company subleased the remaining 25,000 square feet through the remainder of the term of the master
lease. These subleases cover a portion of the Companys lease commitment and all of its insurance,
taxes and common area maintenance. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the accompanying
Consolidated Statements of Operations. As of September 30, 2008, the Company is obligated to pay
rent on the Hayward facility of $3.6 million. Over the remaining term of the master lease the
Company anticipates that it will receive approximately $1.6 million in sublease income to be used
to pay a portion of its Hayward facility obligation. As of September 30, 2008 and December 31,
2007, the estimated liability related to the Hayward facility totaled $1.3 million and $1.6
million, respectively, and is included in Lease Termination and Deferred Rent Liabilities in the
accompanying Consolidated Balance Sheets. The fair value of the liability was determined using a
credit-adjusted risk-free rate to discount the estimated future net cash flows, consisting of the
minimum lease payments under the master lease, net of estimated sublease rental income that could
reasonably be obtained from the property. The Company is also required to recognize an on-going
accretion expense representing the difference between the undiscounted net cash flows and the
discounted net cash flows over the remaining term of the Hayward master lease using the interest
method. The accretion amount represents an on-going adjustment to the estimated liability. The
Company reviews the assumptions used in determining the estimated liability quarterly and revises
its estimate of the liability to reflect changes in circumstances.
The Company, as permitted under California law and in accordance with its Bylaws, indemnifies
its officers and directors for certain events or occurrences while the officer or director is or
was serving at the Companys request in such capacity. The potential future indemnification limit
is to the fullest extent permissible under California law; however, the Company has a director and
officer insurance policy that limits its exposure and may enable it to recover a portion of any
future amounts paid. The Company believes the fair value of these indemnification agreements is
minimal. Accordingly, the Company has no liabilities recorded for these agreements as of September
30, 2008 and December 31, 2007.
The Company has entered into employment agreements with its corporate officers that provide
for, among
other things, base compensation and/or other benefits in certain circumstances in the event of
termination or a change in control. In addition, certain of the agreements provide for the
accelerated vesting of outstanding unvested stock options upon a change in control.
From time to time, the Company may become involved in claims and other legal matters arising
in the ordinary course of business. Management is not currently aware of any such matters that will
have a material adverse affect on the financial position, results of operations or cash flows of
the Company.
10
8. NET INCOME PER SHARE
Basic net income per share is computed using the two-class method. Under the two-class method,
undistributed net income is allocated to common stock and participating securities based on their
respective rights to share in dividends. The Companys Series A Preferred Stock was a participating
security for periods prior to its repurchase on February 19, 2008 (see Note 11). As a result, the
Company allocated a portion of net income to its Series A Preferred Stock on a pro rata basis for
the three and nine month periods ended September 30, 2007. Net income allocated to the Series A
Preferred Stock is excluded from the calculation of basic net income per share applicable to common
shareholders. For basic net income per share applicable to common shareholders, net income
applicable to common shareholders is divided by the weighted average common shares outstanding
during the period. Diluted net income per share gives effect to all potentially dilutive common
shares outstanding during the period such as options, warrants, convertible preferred stock, and
contingently issuable shares.
The following table presents the amounts used in computing basic and diluted net income per
share applicable to common shareholders for the three and nine month periods ended September 30,
2008 and 2007, and the effect of dilutive potential common shares on the number of shares used in
computing basic net income per share applicable to common shareholders. Diluted potential common
shares resulting from the assumed exercise of outstanding stock options and warrants are determined
based on the treasury stock method (in thousands, except per share amounts).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income applicable to common shareholders |
|
$ |
8,955 |
|
|
$ |
8,364 |
|
|
$ |
19,023 |
|
|
$ |
3,054 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net income per share applicable to common
shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
66,796 |
|
|
|
69,192 |
|
|
|
68,642 |
|
|
|
68,986 |
|
Effect of dilutive potential common shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
3,303 |
|
|
|
32 |
|
|
|
3,516 |
|
|
|
968 |
|
Restricted stock |
|
|
12 |
|
|
|
|
|
|
|
21 |
|
|
|
|
|
Warrants and placement unit options |
|
|
|
|
|
|
|
|
|
|
181 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
70,111 |
|
|
|
69,224 |
|
|
|
72,360 |
|
|
|
69,985 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.13 |
|
|
$ |
0.12 |
|
|
$ |
0.28 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.13 |
|
|
$ |
0.12 |
|
|
$ |
0.26 |
|
|
$ |
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents the amounts excluded from the computation of diluted net income
per share applicable to common shareholders as the inclusion of these securities would have been
anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Stock options |
|
|
1,600 |
|
|
|
6,200 |
|
|
|
1,338 |
|
|
|
5,127 |
|
Restricted stock |
|
|
233 |
|
|
|
43 |
|
|
|
233 |
|
|
|
71 |
|
Series A Preferred Stock |
|
|
|
|
|
|
2,156 |
|
|
|
393 |
|
|
|
2,156 |
|
Warrants and placement unit options |
|
|
|
|
|
|
603 |
|
|
|
|
|
|
|
362 |
|
9. INCOME TAXES
The Company makes certain estimates and judgments in determining income tax expense for
financial statement purposes. These estimates and judgments occur in the calculation of certain tax
assets and liabilities, which arise from differences in the timing of recognition of revenue and
expense for tax and financial statement purposes.
As part of the process of preparing its consolidated financial statements, the Company is
required to estimate its income taxes in each of the jurisdictions in which it operates. This
process involves estimating current tax exposure under the most recent tax laws and assessing
temporary differences resulting from differing treatment of items for tax and accounting purposes.
These differences result in deferred tax assets and liabilities, which are included in the
Companys consolidated balance sheets.
11
Income tax expense for the three and nine month periods ended September 30, 2008 was $6.6
million and $16.7 million, respectively. For the three and nine month periods ended September 30,
2008, the Companys effective tax rate for financial reporting purposes was approximately 42% and
41%, respectively. The Companys year to date tax expense for financial reporting purposes includes
the benefit of the reversal of a valuation allowance associated with a federal net operating loss
carry forward available to the Company in 2009 of approximately $750,000. During the second quarter
of 2008, the Company determined, based on taxable income for the six month period ended June 30,
2008 and anticipated income for 2008 and 2009, that it is more likely than not that these
deferred tax assets would be realized. The tax benefit resulting from the reversal of the valuation
reserve was partially offset by the impact of the difference for financial reporting and tax
purposes of deductions associated with stock-based compensation. The Company currently estimates
that actual tax payments related to 2008 are expected to be paid at a rate of approximately 21%, as
the Company has access to $29.4 million of federal operating loss carryforwards and $157,000 of the
federal research and development credits to reduce its 2008 taxable income. This percentage is
higher than previously estimated because in September 2008, California suspended for two years the
ability to use state operating loss carryforwards and certain credit carryforwards to reduce
taxable income. The Company expects to use these state operating loss carryforwards and certain
credit carryforwards after the two year suspension. The Company has made estimated tax payments of $4.4
million and $8.2 million for the three and nine month periods ended September 30, 2008,
respectively, associated with its estimated 2008 tax obligations. Income tax expense for the three
and nine month periods ended September 30, 2007 was $102,000. The Company had an insignificant tax
rate on its net income for the three and nine month periods ended September 30, 2007 resulting from
its ability to use its net operating loss carryforwards to offset most of its taxable income.
During the three and nine month periods ended September 30, 2008, the Company realized excess
tax benefits of $1.4 million from the exercise of non-qualified stock options and early
dispositions of stock acquired by employees through the exercise of incentive stock options and
purchases under the employee stock purchase plan. These tax benefits were reflected as an increase
in common stock in the Companys consolidated balance sheet.
10. COMPREHENSIVE INCOME (LOSS)
Comprehensive income is comprised of net income and the change in unrealized holding gains and
losses on available-for-sale securities (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income |
|
$ |
8,955 |
|
|
$ |
8,625 |
|
|
$ |
24,290 |
|
|
$ |
3,149 |
|
Change in unrealized gains on available-for-sale securities |
|
|
(22 |
) |
|
|
10 |
|
|
|
(59 |
) |
|
|
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
8,933 |
|
|
$ |
8,635 |
|
|
$ |
24,231 |
|
|
$ |
3,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11. EQUITY TRANSACTIONS
On February 19, 2008, the Company repurchased all of the outstanding 2,155,715 shares of
Series A Preferred Stock from Shire Pharmaceuticals, Inc. for cash consideration of $10.3 million
or $4.80 per share, the same price per preferred share as the closing price per share of the
Companys common stock on February 19, 2008. The Series A Preferred Stock had a carrying value of
$5.1 million. The $5.2 million difference between the $10.3 million repurchase payment and the $5.1
million balance sheet carrying value was accounted for as a deemed dividend and reduced the
Companys net income in the determination of net income applicable to common shareholders in the
accompanying Consolidated Statement of Operations.
On February 29, 2008, the Companys board of directors approved a stock repurchase plan that
provides for the Companys repurchase of up to 7 million of its common shares. Stock repurchases
under this program may be made through either open market or privately negotiated transactions in
accordance with all applicable laws, rules and regulations. Through September 30, 2008, the Company
had repurchased 3,490,900 common shares under its stock repurchase plan for $15.6 million, at an
average price of $4.46 per share.
In addition, on August 13, 2008, the Company completed a board-approved repurchase of
2,200,000 shares of its common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal L.D.A.,
an entity owned by Paolo Cavazza and members of his family, for $10.9 million or $4.95 per share,
and on September 3, 2008, completed a board-approved repurchase of an additional 1,800,000
12
shares of its common stock from Inverlochy Consultadorio & Servicos L.D.A., an entity owned by
Claudio Cavazza, for $9.1 million or $5.06 per share. Both repurchases were made outside of the
Companys existing share repurchase plan.
On February 29, 2008, the Companys board of directors approved a reduction in the offering
period of the Employee Stock Purchase Plan (ESPP) from 12 months to 3 months effective with the
offering period that began on September 1, 2008, eliminated the ability of plan participants to
increase their contribution levels during an offering period and approved an amendment authorizing
the addition of 500,000 shares to the ESPP. In addition, the Companys board of directors approved
an amendment on April 16, 2008, to permanently reduce the maximum offering period available from 27
months to 6 months and to permanently remove the ability of ESPP participants to increase their
contributions during an offering period. These amendments to the ESPP were approved by shareholders
at the Companys annual shareholders meeting on May 29, 2008.
In May and June 2008, a total of 348,227 shares of the Companys common stock were issued upon
the cashless net exercise of 475,248 warrants. As of September 30, 2008, the Company no longer has
any warrants outstanding.
12. RECENTLY ISSUED ACCOUNTING STANDARDS
In October 2008, the FASB issued FASB Staff Position No. FAS 157-3, Determining the Fair Value
of a Financial Asset When the Market for That Asset Is Not Active (FSP FAS 157-3). FSP FAS 157-3
clarifies the application of SFAS 157 in a market that is not active and illustrates how an entity
would determine fair value when the market for a financial asset is not active. FSP FAS 157-3
provides guidance on how an entitys own assumptions about cash flows and discount rates should be
considered when measuring fair value when relevant market data does not exist, how observable
market information in an inactive or dislocated market affects fair value measurements and how the
use of broker and pricing service quotes should be considered when applying fair value
measurements. FSP FAS 157-3 is effective immediately as of September 30, 2008 and for all interim
and annual periods thereafter. The adoption of FSP FAS 157-3 did not have a material impact on the
Companys consolidated financial statements.
In April 2008, the FASB issued FSP FAS No.142-3, Determination of the Useful Life of
Intangible Assets (FSP FAS No. 142-3). In determining the useful life of intangible assets, FSP
FAS No. 142-3 removes the requirement to consider whether an intangible asset can be renewed
without substantial cost of material modifications to the existing terms and conditions and,
instead, requires an entity to consider its own historical experience in renewing similar
arrangements. FSP FAS No. 142-3 also requires expanded disclosure related to the determination of
intangible asset useful lives. FSP FAS No. 142-3 is effective for financial statements issued for
fiscal years beginning after December 15, 2008. The Company does not expect that the adoption of
FSP FAS No. 142-3 will have a material impact on its financial position and results of operations.
In February 2008, the FASB issued FASB Staff Position No. FAS 157-2, Effective Date of FASB
Statement No. 157 (FSP FAS No. 157-2), which defers the effective date of SFAS No. 157 for all
non-financial assets and non-financial liabilities, except those that are recognized or disclosed
at fair value in the financial statements on a recurring basis (at least annually), for fiscal
years beginning after November 15, 2008 and interim periods within those fiscal years for items
within the scope of FSP FAS No. 157-2. The Company does not expect that the adoption of FSP FAS No.
157-2 will have a material impact on its financial position and results of operations.
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations (SFAS No. 141(R)),
which replaces FAS No. 141. SFAS No. 141(R) establishes principles and requirements for how an
acquirer in a business combination recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, and any controlling interest; recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain purchase; and
determines what information to disclose to enable users of the financial statements to evaluate the
nature and financial effects of the business combination. SFAS No. 141(R) is to be applied
prospectively to business combinations for which the acquisition date is on or after an entitys
fiscal year that begins after December 15, 2008. The Company will assess the impact of SFAS No.
141(R) if and when a future acquisition occurs.
In November 2007, the EITF issued EITF Issue No. 07-1, Accounting for Collaborative
Arrangements Related to the Development and Commercialization of Intellectual Property (EITF
07-1). Companies may enter into arrangements with other companies to jointly develop, manufacture,
distribute, and market a product. Often the activities associated with these arrangements are
conducted by the collaborators without the creation of
a separate legal entity (that is, the arrangement is operated as a virtual joint venture).
The arrangements generally provide that the collaborators will share, based on contractually
defined calculations, the profits or losses
13
from the associated activities. Periodically, the collaborators share financial information
related to product revenues generated (if any) and costs incurred that may trigger a sharing
payment for the combined profits or losses. The consensus requires collaborators in such an
arrangement to present the result of activities for which they act as the principal on a gross
basis and report any payments received from (made to) other collaborators based on other applicable
GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting
literature or a reasonable, rational, and consistently applied accounting policy election. EITF
07-1 is effective for collaborative arrangements in place at the beginning of the annual period
beginning after December 15, 2008. The Company does not expect that the adoption of EITF 07-1 will
have a material impact on the Companys financial position and results of operations.
13. DISTRIBUTION AGREEMENT
On April 18, 2008, the Company amended its distribution agreement with CuraScript, its U.S.
distributor for H.P. Acthar Gel. The amendment became effective on June 1, 2008. Under the new
terms, the discount provided by the Company to CuraScript is reduced from $1,047 per vial to $230
per vial. The new discounted sales price to CuraScript is $23,039 per vial and the stated list
price remains at $23,269 per vial. Under the new terms the pricing to CuraScript customers is
unchanged. The amount of the discount to CuraScript is subject to annual adjustments based on the
Consumer Price Index. In addition, the payment terms have been reduced from 60 days to 30 days.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Except for the historical information contained herein, the following discussion contains
forward-looking statements that involve risks and uncertainties. Our actual results could differ
materially from those discussed herein. Factors that could cause or contribute to such differences
include, but are not limited to, those discussed in this section, as well as those discussed in our
Annual Report on Form 10-K for the year ended December 31, 2007, including Item 1 Business of
Questcor, and Item 1A Risk Factors, as well as factors discussed in any documents incorporated
by reference herein or therein. Whenever used in this Quarterly Report, the terms Questcor,
Company, we, our, ours, and us refer to Questcor Pharmaceuticals, Inc. and its
consolidated subsidiary.
Overview
We currently market two commercial products, H.P. Acthar Gel (repository corticotropin
injection) and Doral (quazepam). H.P. Acthar Gel (Acthar) is an injectable drug that is approved
for the treatment of certain disorders with an inflammatory component, including the treatment of
exacerbations associated with multiple sclerosis (MS), and the treatment of Nephrotic Syndrome.
In addition, Acthar is not indicated for, but is used in treating patients with infantile spasms
(IS), a rare form of refractory childhood epilepsy, and opsoclonus myoclonus syndrome, a rare
autoimmune-related childhood neurological disorder. Doral is indicated for the treatment of
insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early
morning awakenings. We are also developing QSC-001, a unique orally disintegrating tablet
formulation of hydrocodone bitartrate and acetaminophen for the treatment of moderate to moderately
severe pain in patients with swallowing difficulties.
In August 2007, we announced our Acthar-centric business strategy. In connection with the new
strategy, we implemented a new pricing level for Acthar which was effective August 27, 2007. We
also expanded our sponsorship of Acthar patient assistance and co-pay assistance programs, which
provide an important safety net for uninsured and under-insured patients using Acthar, and
established a group of product service consultants and medical science liaisons to work with
healthcare providers who administer Acthar. As a result, we are not aware of a single patient who
needs Acthar but has not been able to access it. This was not the case before our strategy change.
Because we are now economically viable, we have significantly improved our ability to maintain the
long-term availability of Acthar and fund important medical research projects that have the goal of
improving patient care. We have been working closely with the neurology community to identify
promising new projects for which we can provide needed financial support. We are providing support
to leading researchers in their efforts to better understand the underlying disease processes that
cause infantile spasms, a subject for which there
has been little research funding in recent decades. We are also in discussions with experts in
other disease states with high unmet medical needs for which there is a potential therapeutic role
for Acthar.
Acthar is currently approved in the U.S. for the treatment of exacerbations associated with
MS, Nephrotic Syndrome and many other conditions with an inflammatory component. No drug is
approved in the U.S. for the treatment of IS, a potentially life-threatening disorder that
typically begins in the first year of life. However, pursuant to guidelines published by the
American
14
Academy of Neurology and the Child Neurology Society, many child neurologists use Acthar to treat
infants afflicted with IS. In June 2006, we submitted a Supplemental New Drug Application (sNDA)
to the FDA and are currently pursuing formal agency approval of an indication for the use of Acthar
in the treatment of IS. In May 2007, we received an action letter from the FDA indicating that our
sNDA was not approvable in its current form. In November 2007, we met with the FDA to further
discuss our sNDA. At the meeting, the FDA concurred with our suggested pathway to resubmit the
application with additional information. Our efforts are focused on two major projects involving
the compilation and analysis of efficacy data from prior, randomized controlled trials and safety
data from prior studies as well as historical patient records. Our goal is to submit the additional
information to the FDA by the end of 2008. At this time, the FDA is not requiring us to conduct a
clinical trial to support our resubmission.
Our strategy is to focus on growth initiatives for Acthar, continue the development of
QSC-001, improve operational efficiencies, and return cash to shareholders through repurchases of
our common stock. Our most important growth initiative is the planned 2008 resubmission to the FDA
of the sNDA in support of a new indication for IS. Should the FDA grant approval for this
indication, we could then begin promoting the use of Acthar in this indication, something we are
presently prohibited from doing. We believe that such promotion has the potential to increase usage
of Acthar in IS beyond current levels.
We are also currently working on a number of initiatives aimed at developing future growth
opportunities for Acthar in therapeutic areas other than IS. These include in-depth evaluation of
uses that are currently a part of the extensive list of on-label indications for Acthar. For
example, we have observed some continued usage, as well as favorable insurance coverage, in the
subset of MS patients who do not respond to, or who cannot tolerate, IV corticosteroids, the
first-line treatment of most neurologists for MS flares. Market research indicates that many MS
flare patients may be in this subset. In response, we have modestly increased our promotional
efforts directed to MS specialists to further explore the potential of this opportunity in the
coming months. Early results from our increased promotional efforts directed to MS specialists are
positive, as new prescriptions for Acthar in the treatment of MS have increased from the second
quarter of 2008. We are also looking at other indications that could provide additional patient
benefits and sales growth potential for Acthar. In October 2008, we announced that we are
evaluating Nephrotic Syndrome as a potential new growth opportunity for Acthar. Nephrotic Syndrome
is characterized by excessive spilling of protein from the kidneys into the urine, known as
proteinuria. Acthar is specifically indicated to induce a diuresis or a remission of proteinuria
in the Nephrotic Syndrome without uremia of the idiopathic type or that due to lupus
erythamatosus. If not adequately treated, patients suffering from Nephrotic Syndrome can often
progress to end-stage renal disease. Nephrotic Syndrome can be caused by a number of different
diseases and disorders of the kidney. We have been in discussions with leading nephrologists and
currently expect an exploratory study with Acthar in Nephrotic Syndrome to begin in the first
quarter of 2009 in order to increase our knowledge of the role of Acthar in the treatment of
Nephrotic Syndrome.
During the third quarter of 2008, we completed formulation development of QSC-001 and expect
to begin pivotal bioequivalence trials in the second quarter of 2009.
The August 2007 implementation of our Acthar-centric business strategy fundamentally changed
the nature of Questcor and the success of that strategy to date has resulted in significantly
improved financial results for the three and nine month periods ended September 30, 2008 as
compared to the corresponding periods in the prior year. Our results of operations may vary
significantly from quarter to quarter depending on, among other factors, demand for our products by
patients, inventory levels of our products held by third parties, the amount of Medicaid rebates on
our products dispensed to Medicaid eligible patients, the amount of chargebacks on the sale of our
products by our specialty distributor to government-supported entities, the availability of
finished goods from our sole-source manufacturers, the timing of certain expenses, the timing and
amount of our product development expenses, the introduction of a competitive product, and our
ability to develop growth opportunities for Acthar.
Critical Accounting Policies
Our managements discussion and analysis of our financial condition and results of operations
is based upon our consolidated financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of these financial statements
requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate our
estimates, including those related to our Medicaid rebate obligation related to our products
dispensed to Medicaid eligible patients, chargebacks on sales of our products by wholesalers and
our specialty distributor to government-supported entities, product returns, bad debts,
inventories, intangible assets, share-based compensation, lease termination liability and income
taxes. We base our estimates on historical experience and on various other assumptions that we
believe are reasonable under the circumstances, the results of which form the basis for making
judgments about
15
the carrying values of assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates. We believe the following critical accounting
policies affect our more significant judgments and estimates used in the preparation of our
consolidated financial statements.
Sales Reserves
For the three and nine month periods ended September 30, 2008 and 2007, we have estimated
reserves for product returns from our specialty distributor, wholesalers, hospitals and pharmacies;
government chargebacks for sales of our products by wholesalers and our specialty distributor to
certain Federal government organizations including the Veterans Administration; Medicaid rebates to
all states for products dispensed to patients covered by Medicaid; and cash discounts for prompt
payment on our sales of Doral. We estimate our reserves by utilizing historical information for our
existing products and data obtained from external sources.
Significant judgment is inherent in the selection of assumptions and the interpretation of
historical experience as well as the identification of external and internal factors affecting the
estimates of our reserves for product returns, government chargebacks, and Medicaid rebates. We
believe that the assumptions used to estimate these sales reserves are the most reasonably likely
assumptions considering known facts and circumstances. However, our product returns, government
chargebacks, and Medicaid rebates could differ significantly from our estimates because our
analysis of product shipments, prescription trends, the amount of product in the distribution
channel, and our interpretation of the Medicaid statute and regulations, may not be accurate. If
actual product returns, government chargebacks, and Medicaid rebates are significantly different
from our estimates, such differences would be accounted for in the period in which they become
known. To date, actual amounts have been generally consistent with our estimates.
During July 2007, we began utilizing CuraScript, a third party specialty distributor, to store
and distribute Acthar. Effective August 1, 2007, we no longer sell Acthar to wholesalers and all of
our proceeds from sales of Acthar in the United States are received from CuraScript. We sell Acthar
to CuraScript at a discount from our list price. Gross product sales are recognized net of this
discount upon receipt of the product by CuraScript. In April 2008, we announced the amendment to
our distribution agreement with CuraScript, which became effective on June 1, 2008. Under the new
terms, the discount provided by us to CuraScript is reduced from $1,047 per vial to $230 per vial.
The new discounted sales price to CuraScript is $23,039 per vial and the stated list price remains
at $23,269. However, under the new terms the pricing to CuraScript customers is unchanged. The
amount of the discount to CuraScript is subject to annual adjustments based on the Consumer Price
Index. In addition, the payment terms have been reduced from 60 days to 30 days from when product
is received by CuraScript. We will supply replacement product to CuraScript on product returned
between one month prior to expiration to three months post expiration. Returns from product lots
will be exchanged for replacement product, and estimated costs for such exchanges, which include
actual product material costs and related shipping charges, are included in cost of sales. A
reserve for estimated future replacements has been recorded as a liability within sales-related
reserves which will be reduced as future replacements occur, with an offset to product inventories.
We issue credit memoranda or reimburse wholesalers or their customers for product sold to
wholesalers that is returned within six months beyond the expiration date. The credit memoranda or
reimbursement is equal to the sales value of the product returned and the estimated amount of such
obligation is recorded as a liability within sales-related reserves with a corresponding reduction
in gross product sales. This liability is reduced as the obligation is satisfied, with an offset to
accounts receivable. The reserve for the sales value of expired product expected to be returned by
wholesalers and their customers relates to estimated returns associated with our sales of Doral and
our estimate of returns associated with sales of Acthar to wholesalers prior to our transition to
CuraScript in July 2007. In estimating the return rate for expired product returned by wholesalers
and their
customers, we primarily analyze historical returns by product and return merchandise
authorizations. We also consider current inventory on hand at wholesalers, the remaining shelf life
of that inventory, and changes in demand measured by prescriptions or other data as provided by an
independent third party source. We believe that the information obtained from wholesalers regarding
inventory levels and from independent third parties regarding prescription demand is reliable, but
we are unable to independently verify the accuracy of such data. We routinely assess our historical
experience including customers compliance with our product return policy, and we change our
reserve estimates as appropriate.
16
We provide a rebate related to product dispensed to Medicaid eligible patients. Our a)
estimated historical rebate percentage, adjusted for b) recent and expected future utilization
rates for these programs, is used to estimate the rebate units associated with product shipped
during a period as follows:
|
a) |
|
The estimated historic liability included in sales-related reserves as of the end of a
period is comprised of the estimated rebate units associated with estimated end user demand during
the period, the estimated rebate units associated with estimated inventory in the distribution
channel as of the end of the period, and the estimated rebate units, if any, associated with prior
rebate periods. |
|
|
b) |
|
In order to assess current and future rates of Medicaid utilization, we analyze inventory
levels and patient prescription data received from a third party, CuraScript. |
The rebate amount per unit is determined based on a formula established by statute and is
subject to review and modification by the administrators of the Medicaid program. The rebate per
unit formula is comprised of a basic rebate of 15.1% applied to the average per unit amount of
payments we receive on our product sales and an additional per unit rebate that is based on our
current sales price compared to our sales price on an inflation adjusted basis from a designated
base period. We multiply the rebate amount per unit by the estimated rebate units to arrive at
the estimated reserve for the period. This estimated reserve is deducted from gross sales in the
determination of net sales. Effective January 1, 2008, the amount we rebate for each Acthar vial
dispensed to a Medicaid eligible patient is approximately $2,500 higher than our price to
CuraScript. Management believes that the information received from CuraScript related to
prescription data and inventory levels is reliable, but we are unable to independently verify the
accuracy of such data. During the third quarter of 2008, based on higher rebate usage reflected in
the prescription data provided by CuraScript, we revised our estimate for Medicaid rebates. The
effect of this revision was to reduce net sales by $1.4 million, and decrease net income per share
by approximately $0.01 for the three and nine month periods ended September 30, 2008.
Certain government-supported entities are permitted to purchase our products for a nominal
amount from wholesalers and CuraScript. The wholesalers and CuraScript charge the significant
discount back to us and reduce subsequent payment to us by the amount of the approved chargeback.
The chargeback approximates our sales price to our customers. As a result, we recognize nominal, if
any, net sales on shipments to these entities that qualify for the government chargeback. The
reduction to gross sales for a period related to chargebacks is comprised of actual approved
chargebacks originating during the period and an estimate of chargebacks in the ending inventory of
our customers. In estimating the government chargeback reserve as of the end of a period, we
estimate the amount of chargebacks in our customers ending inventory using actual average monthly
chargeback amounts and ending inventory balances provided by our largest customers.
We routinely assess our experience with Medicaid rebates and government chargebacks and change
the reserve estimates as appropriate. For sales of Doral, we grant payment terms of 2%, net 30
days. Allowances for cash discounts are recorded as a reduction to trade accounts receivable and
are estimated based upon the amount of trade accounts receivable subject to the cash discounts.
At September 30, 2008 and December 31, 2007, sales-related reserves included in the
accompanying Consolidated Balance Sheets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Medicaid rebates |
|
$ |
13,478 |
|
|
$ |
6,514 |
|
Government chargebacks |
|
|
58 |
|
|
|
222 |
|
Product returns credit memoranda policy |
|
|
391 |
|
|
|
1,307 |
|
Product returns product replacement policy |
|
|
48 |
|
|
|
31 |
|
Other |
|
|
|
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
$ |
13,975 |
|
|
$ |
8,176 |
|
|
|
|
|
|
|
|
Inventories
As of September 30, 2008, our net raw material, work in process and finished goods inventories
totaled $2.4 million. We maintain inventory reserves primarily for excess and obsolete inventory
(due to the expiration of shelf life of a product). In estimating inventory excess and obsolescence
reserves, we analyze (i) the expiration date, (ii) our sales forecasts and (iii) historical demand.
Judgment is required in determining whether the forecasted sales information is sufficiently
reliable to enable us to reasonably estimate excess and obsolete inventory. If actual future usage
and demand for our products is less favorable than projected, additional inventory write-offs may
be required in the future which would increase our cost of sales in the period of any write-offs.
We intend to control inventory levels of our products purchased by our customers. Customer
inventories may be compared to both internal and external databases to
determine adequate inventory levels. We may monitor our product shipments to customers and
compare these shipments against prescription demand for our individual products.
17
Intangible and Long-Lived Assets
As of September 30, 2008, our intangible and long-lived assets consisted of goodwill of
$299,000 generated from a merger in 1999, net purchased technology of $3.7 million related to our
acquisition of Doral and $426,000 of net property and equipment. The determination of whether or
not our intangible and long-lived assets are impaired and the expected useful lives of purchased
technology involves significant judgment. Changes in strategy or market conditions could
significantly impact these judgments and require a write-down of our recorded asset balances and a
reduction in the expected useful life of our purchased technology. Such a write-down of our
recorded asset balances or reduction in the expected useful life of our purchased technology would
increase our operating expenses. In accordance with SFAS No. 142, Goodwill and Other Intangible
Assets, we review goodwill for impairment on an annual basis. Our fair value is compared to the
carrying value of our net assets, including goodwill. If the fair value is greater than the
carrying amount, then no impairment is indicated. In accordance with SFAS No. 144, Accounting for
the Impairment or Disposal of Long-Lived Assets, we review long-lived assets, consisting of
property and equipment and purchased technology, for impairment whenever events or circumstances
indicate that the carrying amount may not be fully recoverable. Recoverability of assets is
measured by comparison of the carrying amount of the asset to the net undiscounted future cash
flows expected to be generated from the use or disposition of the asset. If the future undiscounted
cash flows are not sufficient to recover the carrying value of the assets, the assets carrying
value is adjusted to fair value. As of September 30, 2008, no impairment had been indicated.
Share-Based Compensation Expense
Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No.
123(R), using the modified-prospective transition method. Under the fair value recognition
provisions of SFAS No. 123(R), share-based compensation cost is estimated at the grant date based
on the fair value of the award and is recognized as expense, net of estimated pre-vesting
forfeitures, ratably over the vesting period of the award. We selected the Black-Scholes option
pricing model as the most appropriate fair value method for our awards. Calculating share-based
compensation expense requires the input of highly subjective assumptions, including the expected
term of the share-based awards, stock price volatility, and pre-vesting forfeitures. We estimated
the expected term of stock options granted for the three and nine month periods ended September 30,
2008 based on the historical term of our stock option awards. We estimated the expected term of
stock options granted for the three and nine month periods ended September 30, 2007 based on the
simplified method provided in Staff Accounting Bulletin No. 107. We estimated the volatility of our
common stock at the date of grant based on the historical volatility of our common stock. The
assumptions used in calculating the fair value of share-based awards represent our best estimates,
but these estimates involve inherent uncertainties and the application of management judgment. As a
result, if factors change and we use different assumptions, our share-based compensation expense
could be materially different in the future. In addition, we are required to estimate the expected
pre-vesting forfeiture rate and only recognize expense for those shares expected to vest. We
estimate the pre-vesting forfeiture rate based on historical experience. If our actual forfeiture
rate is materially different from our estimate, our share-based compensation expense could be
significantly different from what we have recorded in the current period.
Our net income for the three and nine month periods ended September 30, 2008 includes $635,000
and $3.7 million, respectively, of share-based compensation expense related to employees and
non-employee members of our board of directors. Our net income for the three and nine month periods
ended September 30, 2007 includes
$223,000 and $1.1 million, respectively, of share-based compensation expense related to
employees and non-employee members of our board of directors.
On February 29, 2008, our board of directors approved a reduction in the offering period of
the Employee Stock Purchase Plan (ESPP) from 12 months to 3 months effective with the offering
period that began on September 1, 2008, eliminated the ability of plan participants to increase
their contribution levels during an offering period and authorized the addition of 500,000 shares
to the ESPP. In addition, our board of directors approved an amendment on April 16, 2008, to
permanently reduce the maximum offering period available from 27 months to 6 months and to
permanently remove the ability of ESPP participants to increase their contributions during an
offering period. These amendments to the ESPP were approved by our board of directors on February
29, 2008, and April 16, 2008 and by our shareholders at our annual shareholders meeting on May 29,
2008. These plan changes to the ESPP were effective with the offering period that began on
September 1, 2008 and could lead to lower expenses for the ESPP in future periods.
18
Lease Termination Liability
We entered into an agreement to sublease laboratory and office space, including laboratory
equipment, at our Hayward, California facility in July 2000, due to the termination of our then
existing drug discovery programs. The sublease on our Hayward facility expired in July 2006. Our
obligations under the Hayward master lease extend through November 2012. During the fourth quarter
of 2005, the sublessee notified us that they did not intend to extend the sublease beyond the end
of July 2006.
We determined that there was no loss associated with the Hayward facility when we initially
subleased the space as we expected cash inflows from the sublease to exceed our rent cost over the
term of the master lease. However, we reevaluated this in 2005 when the sublessee notified us that
it would not be renewing the sublease beyond July 2006. As a result, we computed a loss and
liability on the sublease in the fourth quarter of 2005 in accordance with FIN 27: Accounting for a
Loss on a Sublease, an interpretation of FASB 13 and APB Opinion No. 30 and FTB 79-15, Accounting
for the Loss on a Sublease Not Involving the Disposal of a Segment. As of September 30, 2008 and
December 31, 2007, the estimated liability related to the Hayward facility totaled $1.3 million and
$1.6 million, respectively, and is included in Lease Termination and Deferred Rent Liabilities in
the accompanying Consolidated Balance Sheets. The fair value of the liability was determined using
a credit-adjusted risk-free rate to discount the estimated future net cash flows, consisting of the
minimum lease payments under the master lease, net of estimated sublease rental income that could
reasonably be obtained from the property. The most significant assumption in estimating the lease
termination liability relates to our estimate of future sublease income. We base our estimate of
sublease income, in part, on the opinion of independent real estate experts, current market
conditions, and rental rates, among other factors. Adjustments to the lease termination liability
will be required if actual sublease income differs from amounts currently expected. We review all
assumptions used in determining the estimated liability quarterly and revise our estimate of the
liability to reflect changes in circumstances. Effective November 1, 2007, we subleased 5,000
square feet of the facility through April 2009 and effective February 1, 2008 we subleased the
remaining 25,000 square feet through the remainder of the term of the master lease. These subleases
cover a portion of our lease commitment, and all of our insurance, taxes and common area
maintenance. As of September 30, 2008, we are obligated to pay rent on the Hayward facility of $3.6
million. Over the remaining term of the master lease, we anticipate that we will receive
approximately $1.6 million in sublease income to be used to pay a portion of our Hayward facility
obligation.
We are also required to recognize an on-going accretion expense representing the difference
between the undiscounted net cash flows and the discounted net cash flows over the remaining term
of the Hayward master lease using the interest method. The accretion amount represents an on-going
adjustment to the estimated liability. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the accompanying
Consolidated Statements of Operations.
Income Taxes
We make certain estimates and judgments in determining income tax expense for financial
statement purposes. These estimates and judgments occur in the calculation of certain tax assets
and liabilities, which arise from differences in the timing of recognition of revenue and expense
for tax and financial statement purposes.
As part of the process of preparing our consolidated financial statements, we are required to
estimate our
income taxes in each of the jurisdictions in which we operate. This process involves us
estimating our current tax exposure under the most recent tax laws and assessing temporary
differences resulting from differing treatment of items for tax and accounting purposes. These
differences result in deferred tax assets and liabilities, which are included in our consolidated
balance sheets.
We regularly assess the likelihood that we will be able to recover our deferred tax assets. We
consider all available evidence, both positive and negative, including historical levels of income,
expectations and risks associated with estimates of future taxable income and ongoing prudent and
feasible tax planning strategies in assessing the need for a valuation allowance. If it is not more
likely than not that we will recover our deferred tax assets, we will increase our provision for
taxes by recording a valuation allowance against the deferred tax assets that we estimate will not
ultimately be recoverable. As a result of our analysis of all available evidence, both positive and
negative, as of December 31, 2006, it was not considered more likely than not that our deferred
tax assets would be realized and, accordingly, we recorded a full valuation allowance against the
deferred tax assets. Based on taxable income in the third and fourth quarter of 2007, cumulative
taxable income for the most recent three years and anticipated taxable income for 2008, we
determined, in the fourth quarter of 2007, that it was more likely than not that some of the
deferred tax assets would be recovered. Accordingly, we reversed the valuation allowance for such
deferred tax assets at December 31, 2007 and recorded an income tax benefit of $15.9 million for
the year ended December 31, 2007. The remaining valuation allowance at December 31, 2007 related to
19
deferred tax assets for federal net operating loss and tax credit carryforwards and certain state
temporary differences that may not be recovered until 2009 or subsequent years. During the second
quarter of 2008 we determined that it was more likely than not that the portion of the reserved
deferred tax asset associated with a federal net operating loss carry forward available to us in
2009 would be recovered and recorded an income tax benefit of approximately $750,000. Any changes
in the valuation allowance based upon our future assessment will result in an income tax benefit if
the valuation allowance is decreased, and an income tax expense if the valuation allowance is
increased.
During the three and nine month periods ended September 30, 2008, our effective tax rate for
financial reporting purposes was approximately 42% and 41%, respectively. Our year to date tax
expense for financial reporting purposes includes the benefit of the reversal of the valuation
allowance discussed above. This tax benefit was partially offset by the impact of the difference
for financial reporting and tax purposes of deductions associated with stock-based compensation.
Results of Operations
Three months ended September 30, 2008 compared to the three months ended September 30, 2007:
Total Net Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net sales |
|
$ |
24,200 |
|
|
$ |
14,809 |
|
|
$ |
9,391 |
|
|
|
63 |
% |
Net sales for the three month periods ended September 30, 2008 and 2007 were comprised of net
sales of our neurology products Acthar and Doral. Net sales of Acthar for the three month period
ended September 30, 2008 totaled $24.0 million as compared to $14.6 million during the same period
in 2007. The increase in net sales is due primarily to a full quarter under the new Acthar pricing
level implemented in August 2007. In August 2007 we announced a new strategy and business model for
Acthar, and initiated a new pricing level for Acthar that was effective August 27, 2007. Under the
new Acthar strategy, our sales price to CuraScript, our specialty distributor of Acthar, increased
to $22,222 per vial based on a list price of $23,269 per vial. Effective June 1, 2008, the
discounted sales price to CuraScript increased to $23,039 per vial based on a list price of $23,269
per vial. The list price prior to the new Acthar pricing level was $1,650 per vial. While total
Acthar units shipped have decreased since the implementation of the new Acthar strategy, we shipped
1,500 Acthar units to our specialty distributor during the third quarter of 2008. This continued
ordering coupled with a positive pattern of insurance reimbursement and rapid patient access to
Acthar has resulted in a significant increase in our net sales. However, future Acthar orders may
be impacted by several factors, including inventory practices at specialty and hospital pharmacies,
greater use of patient assistance programs, the overall pattern of usage by the healthcare
community, including Medicaid and government-supported entities, the FDA approval of a competitive
product, and the reimbursement policies of insurance companies.
A previous analysis of pre-2008 data suggested that Acthar end user demand was impacted by
seasonality as well as quarter to quarter variability driven by the relatively small IS patient
population. However, with the exception of a decrease in Acthar end user demand in February 2008,
this historical pattern of seasonality and quarterly variation has not been apparent during 2008.
We will continue to monitor these factors as there may be volatility in our Acthar shipments and
end user demand in future periods.
As required by federal regulations, we provide a rebate related to product dispensed to
Medicaid eligible patients. In addition, government-supported entities are permitted to purchase
our products for a nominal amount from our customers who charge back the significant discount to
us. These Medicaid rebates and government chargebacks are estimated by us each quarter and reduce
our gross sales in the determination of our net sales. Effective January 1, 2008, the amount we
rebate for each Acthar vial dispensed to a Medicaid eligible patient is approximately $2,500 higher
than our price to our specialty distributor. For the three months ended September
30, 2008, Acthar gross sales were reduced by approximately 31% to account for the estimated
amount of Medicaid rebates and government chargebacks. During the third quarter of 2008, based on
higher rebate usage reflected in patient prescription data provided by CuraScript, we revised our
estimate for Medicaid rebates. The effect of this revision was to reduce net sales by $1.4 million,
and decrease net income per share by approximately $0.01 for the three month period ended September
30, 2008.
20
We review the amount of inventory of Doral at wholesalers and Acthar at CuraScript in order to
help assess the demand for our products. We may choose to defer sales in situations where we
believe inventory levels are already adequate. We expect quarterly fluctuations in net sales due to
changes in demand for our products, the timing of shipments, changes in inventory levels,
expiration dates of product sold, and the impact of our sales-related reserves.
Cost of Sales and Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Cost of sales |
|
$ |
1,937 |
|
|
$ |
1,534 |
|
|
$ |
403 |
|
|
|
26 |
% |
Gross profit |
|
$ |
22,263 |
|
|
$ |
13,275 |
|
|
$ |
8,988 |
|
|
|
68 |
% |
Gross margin |
|
|
92 |
% |
|
|
90 |
% |
|
|
|
|
|
|
|
|
Cost of sales includes material cost, packaging, warehousing and distribution, product
liability insurance, royalties, quality control (which primarily includes product stability
testing), quality assurance and reserves for excess or obsolete inventory. The increase in cost of
sales was due primarily to an increase of approximately $400,000 in royalties on Acthar due to the
increase in net sales during the three month period ended September 30, 2008 as compared to the
same period in 2007. The gross margin was 92% for the three month period ended September 30, 2008,
as compared to 90% for the three month period ended September 30, 2007.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
4,251 |
|
|
$ |
3,322 |
|
|
$ |
929 |
|
|
|
28 |
% |
The increase in selling, general and administrative expense for the three months ended
September 30, 2008 as compared to the same period in 2007 was due primarily to increases in
headcount-related costs, including share-based compensation expense, and general costs associated
with the support of our new Acthar strategy, offset in part by lower expenses associated with our
Hayward facility.
Headcount-related costs included in selling, general and administrative expense, excluding
share-based compensation, increased by approximately $700,000 as compared to the same period in
2007. The increase resulted primarily from an increase in our product service representatives to a
total of 15 representatives during the third quarter of 2008.
We incurred a total non-cash charge of $635,000 for SFAS No. 123(R) share-based compensation
related to employees and non-employee members of our board of directors for the quarter ended
September 30, 2008. Of this amount, $493,000 was included in selling, general and administrative
expenses, an increase of $331,000 as compared to the same period in 2007. The increase in
share-based compensation expense in the third quarter of 2008 was due in part to an approximate
$160,000 increase in expense associated with our employee stock purchase plan. Of the total
non-cash charge of $635,000 in the third quarter of 2008 for share-based compensation expense,
$179,000 was related to our employee stock purchase plan. As a result of the significant increase
in our stock price during the fourth quarter of 2007, many plan participants increased their
contributions to maximum levels for the current offering period. This resulted in a significant
increase in the non-cash SFAS No. 123(R) expense for the 12-month offering period that ended in
August 2008. In February 2008, our board of directors approved a reduction in the offering period
from 12 months to 3 months effective with the offering period that began on September 1, 2008,
eliminated the ability of plan participants to increase their contribution levels during an
offering period and approved an amendment authorizing the addition of 500,000 shares to the plan.
In addition, our board of directors approved an amendment on April 16, 2008, to permanently reduce
the maximum offering period available from 27 months to 6 months and to permanently remove the
ability of ESPP
participants to increase their contributions during an offering period. These amendments to
the plan were approved by shareholders at our annual shareholders meeting on May 29, 2008. We
estimate that these changes could reduce the non-cash SFAS No. 123(R) expense associated with our
employee stock purchase plan beginning with the current offering period that began on September 1,
2008.
21
General costs associated with the support of our new Acthar strategy increased by
approximately $130,000 in the three month period ended September 30, 2008 as compared to general
costs associated with our prior strategy incurred during the same period in 2007.
Expenses associated with our Hayward facility decreased by approximately $273,000 in the three
month period ended September 30, 2008 as compared to the same period in 2007. The decrease is due
primarily to the inclusion in the third quarter of 2007 of a $245,000 loss resulting from a
revision of our estimate of our Hayward lease liability.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
2,577 |
|
|
$ |
1,264 |
|
|
$ |
1,313 |
|
|
|
104 |
% |
Costs included in research and development relate primarily to our product development
efforts, costs related to the resubmission of our Acthar sNDA for IS to the FDA, outside services
related to medical and regulatory affairs, compliance activities, and costs associated with our
medical science liaisons. The increase in research and development expenses was due primarily to an
increase in costs related to our continued efforts to complete the resubmission of our sNDA for IS.
Expenses related to the resubmission of our sNDA and product development increased approximately
$700,000 in the three month period ended September 30, 2008 as compared to the same period in 2007.
Headcount-related costs, excluding share-based compensation, increased by approximately $240,000 in
the three month period ended September 30, 2008 as compared to the same period in 2007, due
primarily to the addition of headcount during 2008. A non-cash charge of $142,000 for SFAS No.
123(R) share-based compensation was included in research and development expenses in the three
month period ended September 30, 2008, an increase of $82,000 as compared to the same period in
2007.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
134 |
|
|
$ |
125 |
|
|
$ |
9 |
|
|
|
7 |
% |
Depreciation and amortization expense for the three months ended September 30, 2008 was
consistent with depreciation and amortization expense for the same period in 2007.
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
209 |
|
|
$ |
163 |
|
|
$ |
46 |
|
|
|
28 |
% |
Other income, net for the three month period ended September 30, 2008 increased $46,000 as
compared to other income, net for the same period in 2007. The increase was due primarily to
increased interest income resulting from higher cash balances during the three month period ended
September 30, 2008 as compared to the same period in 2007.
22
Income Before Income Taxes and Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Income before income taxes |
|
$ |
15,510 |
|
|
$ |
8,727 |
|
|
$ |
6,783 |
|
|
|
78 |
% |
Income tax expense |
|
$ |
6,555 |
|
|
$ |
102 |
|
|
$ |
6,453 |
|
|
|
6,326 |
% |
Income before income taxes for the three month period ended September 30, 2008 was $15.5
million as compared to $8.7 million for the three month period ended September 30, 2007. The
increase was due to the increase in net sales and the changes in expenses discussed above. Income
tax expense for the three month period ended September 30, 2008 was $6.6 million as compared to
$102,000 for the three month period ended September 30, 2007. We had an insignificant tax rate on
our net income for the three month period ended September 30, 2007 resulting from our ability to
use our net operating loss carryforwards to offset most of our taxable income. During the quarter
ended September 30, 2008, our effective tax rate for financial reporting purposes was approximately
42%. We currently estimate that our actual tax payments related to 2008 are expected to be paid at
a rate of approximately 21%, as we have access to $29.4 million of federal operating loss
carryforwards and $157,000 of the federal research and development credits to reduce our 2008
taxable income. This percentage is higher than previously estimated because in September 2008,
California suspended for two years the ability to use state operating loss carryforwards and
certain credit carryforwards to reduce taxable income. We expect to use these state operating loss
carryforwards and certain credit carryforwards after the two year suspension. We made estimated tax
payments of $4.4 million during the three months ended September 30, 2008 associated with our
estimated 2008 tax obligations.
Net Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income |
|
$ |
8,955 |
|
|
$ |
8,625 |
|
|
$ |
330 |
|
|
|
4 |
% |
For the three months ended September 30, 2008, we had net income of $9.0 million as compared
to net income of $8.6 million for the three months ended September 30, 2007, an increase of
$330,000. The increase resulted primarily from a full quarter under our new strategy and business
model for Acthar which was implemented in August 2007, offset by higher income tax expense in the
three month period ended September 30, 2008.
Preferred Stock Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Allocation of undistributed earnings to Series A Preferred Stock |
|
$ |
|
|
|
$ |
261 |
|
|
$ |
(261 |
) |
|
|
(100 |
)% |
We repurchased all of the outstanding Series A Preferred Stock in February 2008 and therefore
net income was not allocated to the Series A Preferred Stock for the three month period ended
September 30, 2008. The $261,000 allocation of undistributed earnings to Series A Preferred Stock
for the three month period ended September 30, 2007 represented an allocation of a portion of our
third quarter 2007 net income to the Series A Preferred Stock for purposes of determining net
income applicable to common shareholders. This is an accounting allocation only and was not an
actual distribution or obligation to distribute a portion of our third quarter 2007 net income to
the Series A stockholder.
Net Income Applicable to Common Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income applicable to common shareholders |
|
$ |
8,955 |
|
|
$ |
8,364 |
|
|
$ |
591 |
|
|
|
7 |
% |
23
For the three months ended September 30, 2008, we had net income applicable to common
shareholders of $9.0 million, or $0.13 per fully diluted share, as compared to net income
applicable to common shareholders of $8.4 million, or $0.12 per fully diluted share, for the three
months ended September 30, 2007, an increase of $591,000. The increase resulted primarily from a
full quarter under our new strategy and business model for Acthar which was implemented in August
2007, offset by higher income tax expense in the three month period ended September 30, 2008.
Nine months ended September 30, 2008 compared to the nine months ended September 30, 2007:
Total Net Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net sales |
|
$ |
68,230 |
|
|
$ |
22,654 |
|
|
$ |
45,576 |
|
|
|
201 |
% |
Net sales for the nine month periods ended September 30, 2008 and 2007 were comprised of net
sales of our neurology products Acthar and Doral. Net sales of Acthar for the nine month period
ended September 30, 2008 totaled $67.6 million as compared to $21.8 million during the same period
in 2007. The increase in net sales resulted from the new Acthar pricing level implemented in August
2007. In August 2007 we announced a new strategy and business model for Acthar, and initiated a new
pricing level for Acthar that was effective August 27, 2007. Under the new Acthar strategy, our
sales price to CuraScript, our specialty distributor of Acthar, increased to $22,222 per vial based
on a list price of $23,269 per vial effective August 27, 2007. Effective June 1, 2008, the
discounted sales price to CuraScript increased to $23,039 per vial based on a list price of $23,269
per vial. The list price prior to the new Acthar pricing level was $1,650 per vial. While total
Acthar units shipped have decreased since the implementation of the new Acthar strategy, we shipped
4,320 Acthar units to our specialty distributor during the first nine months of 2008. This
continued ordering coupled with a positive pattern of insurance reimbursement and rapid patient
access to Acthar has resulted in a significant increase in our net sales. However, future Acthar
orders may be impacted by several factors, including inventory practices at specialty and hospital
pharmacies, greater use of patient assistance programs, the overall pattern of usage by the
healthcare community, including Medicaid and government-supported entities, the FDA approval of a
competitive product, and the reimbursement policies of insurance companies.
A previous analysis of pre-2008 data suggested that Acthar end user demand was impacted by
seasonality as well as quarter to quarter variability driven by the relatively small IS patient
population. However, with the exception of a decrease in Acthar end user demand in February 2008,
this historical pattern of seasonality and quarterly variation has not been apparent during 2008.
We will continue to monitor these factors as there may be volatility in our Acthar shipments and
end user demand in future periods.
As required by federal regulations, we provide a rebate related to product dispensed to
Medicaid eligible patients. In addition, government-supported entities are permitted to purchase
our products for a nominal amount from our customers who charge back the significant discount to
us. These Medicaid rebates and government chargebacks are estimated by us each quarter and reduce
our gross sales in the determination of our net sales. Effective January 1, 2008, the amount we
rebate for each Acthar vial dispensed to a Medicaid eligible patient is approximately $2,500 higher
than our price to our specialty distributor. For the nine months ended September 30, 2008, Acthar
gross sales were reduced by approximately 30% to account for the estimated amount of Medicaid
rebates and government chargebacks. During the third quarter of 2008, based on higher rebate usage
reflected in patient prescription data provided by CuraScript, we revised our estimate for Medicaid
rebates. The effect of this revision was to reduce net sales by $1.4 million, and decrease net
income per share by approximately $0.01 for the nine month period ended September 30, 2008.
Cost of Sales and Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
|
Cost of sales |
|
$ |
5,446 |
|
|
$ |
3,298 |
|
|
$ |
2,148 |
|
|
|
65 |
% |
Gross profit |
|
$ |
62,784 |
|
|
$ |
19,356 |
|
|
$ |
43,428 |
|
|
|
224 |
% |
Gross margin |
|
|
92 |
% |
|
|
85 |
% |
|
|
|
|
|
|
|
|
24
The increase in cost of sales was due primarily to an increase of $1.8 million in royalties on
Acthar due to the increase in net sales during the nine month period ended September 30, 2008 as
compared to the same period in 2007, and an increase of $546,000 in distribution costs in the nine
month period ended September 30, 2008 as compared to the same period in 2007. The increase in
distribution costs is due in part to the inclusion in the nine month period ended September 30,
2007 of credits from wholesalers related to price increases. These increases were partially offset
by a decrease in product stability testing expenses and inventory obsolescence totaling
approximately $420,000 during the nine month period ended September 30, 2008 as compared to the
same period in 2007. The gross margin was 92% for the nine month period ended September 30, 2008,
as compared to 85% for the nine month period ended September 30, 2007. The increase in the gross
margin in the nine month period ended September 30, 2008 as compared to the same period in 2007 was
due primarily to the increase in net sales resulting from the new Acthar pricing level implemented
in August 2007.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
14,172 |
|
|
$ |
13,619 |
|
|
$ |
553 |
|
|
|
4 |
% |
The increase in selling, general and administrative expense was due primarily to an increase
in share-based compensation expense and general costs associated with the support of our new Acthar
strategy, offset in part by lower expenses associated with our Hayward facility and lower headcount
related costs resulting from the reduction of our field organization in the second quarter of 2007.
We incurred a total non-cash charge of $3.7 million for SFAS No. 123(R) share-based
compensation related to employees and non-employee members of our board of directors for the nine
months ended September 30, 2008. Of this amount, $3.0 million was included in selling, general and
administrative expenses, an increase of $2.1 million as compared to the same period in 2007. The
increase in share-based compensation expense in the nine months ended September 30, 2008 was
primarily associated with our employee stock purchase plan. Of the total non-cash charge of $3.7
million in the first nine months of 2008 for share-based compensation expense, $2.0 million was
related to our employee stock purchase plan. As a result of the significant increase in our stock
price during the fourth quarter of 2007, many plan participants increased their contributions to
maximum levels for the current offering period. This resulted in a significant increase in the
non-cash SFAS No. 123(R) expense for the current 12-month offering period. In February 2008, our
board of directors approved a reduction in the offering period from 12 months to 3 months effective
with the offering period that began on September 1, 2008, eliminated the ability of plan
participants to increase their contribution levels during an offering period and approved an
amendment authorizing the addition of 500,000 shares to the plan. In addition, our board of
directors approved an amendment on April 16, 2008, to permanently reduce the maximum offering
period available from 27 months to 6 months and to permanently remove the ability of ESPP
participants to increase their contributions during an offering period. These amendments to the
plan were approved by shareholders at our annual shareholders meeting on May 29, 2008. We estimate
that these changes could reduce the non-cash SFAS No. 123(R) expense associated with our employee
stock purchase plan beginning with the current offering period that began on September 1, 2008.
General costs associated with the support of our new Acthar strategy increased by
approximately $330,000 in the nine month period ended September 30, 2008 as compared to general
costs associated with our prior strategy incurred during the same period in 2007.
Expenses associated with our Hayward facility decreased by approximately $866,000 in the nine
month period ended September 30, 2008 as compared to the same period in 2007. The decrease is due
primarily to the inclusion of losses totaling $646,000 in the nine month period ended September 30,
2007 resulting from revisions of our estimate of our Hayward lease liability.
Headcount related costs included in selling, general and administrative expense, excluding
share-based compensation, decreased by approximately $700,000 as compared to the same period in
2007. Selling, general and administrative expense for the nine month period ended September 30,
2007 includes severance benefits and
other associated costs related to the reduction of our field organization and the departure of
our former Chief Executive Officer in the second quarter of 2007.
25
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
8,103 |
|
|
$ |
3,355 |
|
|
$ |
4,748 |
|
|
|
142 |
% |
The increase in research and development expenses was due primarily to an increase in costs
related to our continued efforts to complete the resubmission of our sNDA for IS, our product
development efforts, and the addition of our medical science liaisons during the second quarter of
2007. Expenses related to the resubmission of our sNDA and expenses associated with our product
development efforts increased approximately $2.4 million in the nine month period ended September
30, 2008 as compared to the same period in 2007. Headcount-related costs, excluding share-based
compensation, increased by approximately $800,000 in the nine month period ended September 30, 2008
as compared to the same period in 2007, due primarily to the addition of our medical science
liaisons during the second quarter of 2007. In addition, activities associated with our medical
science liaisons contributed approximately $400,000 to the increase in research and development
expenses in the nine month period ended September 30, 2008. These activities include the initiation
of basic research funding for infantile spasms. A non-cash charge of $660,000 for SFAS No. 123(R)
share-based compensation was included in research and development expenses in the nine month period
ended September 30, 2008, an increase of $471,000 as compared to the same period in 2007.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
379 |
|
|
$ |
373 |
|
|
$ |
6 |
|
|
|
2 |
% |
Depreciation and amortization expense for the nine months ended September 30, 2008 was
consistent with depreciation and amortization expense for the same period in 2007.
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
828 |
|
|
$ |
1,242 |
|
|
$ |
(414 |
) |
|
|
(33 |
)% |
Other income, net for the nine month period ended September 30, 2008 decreased $414,000 as
compared to other income, net for the same period in 2007. The decrease was due primarily to the
inclusion in the nine month period ended September 30, 2007 of the gain on sale of product rights
related to Emitasol, and the reversal of an accrual of $248,000 related to an agreement with
Roberts Pharmaceutical Corporation, a subsidiary of Shire, as we determined that the amount would
not be due to Shire under the agreement. In June 2007, we divested our non-core development stage
product Emitasol (nasal metoclopramide) which resulted in a gain of $448,000. The decreases were
partially offset by increased interest income resulting from higher cash balances during the nine
month period ended September 30, 2008 as compared to the same period in 2007.
Income Before Income Taxes and Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
September 30, |
|
|
|
|
2008 |
|
2007 |
|
Increase |
|
|
(in $000s) |
|
|
|
Income before income taxes |
|
$ |
40,958 |
|
|
$ |
3,251 |
|
|
$ |
37,707 |
|
Income tax expense |
|
$ |
16,668 |
|
|
$ |
102 |
|
|
$ |
16,566 |
|
26
Income before income taxes for the nine month period ended September 30, 2008 was $41.0
million as compared to $3.3 million for the nine month period ended September 30, 2007. The
increase was due to the increase in net sales and the changes in expenses discussed above. Income
tax expense for the nine month period ended September 30, 2008 was $16.7 million as compared to
$102,000 in the same period in 2007. We had an insignificant tax rate on our net income for the
nine month period ended September 30, 2007 resulting from our ability to use our net operating loss
carryforwards to offset most of our taxable income. During the nine month period ended September
30, 2008, our effective tax rate for financial reporting purposes was approximately 41%. Income tax
expense for financial reporting purposes for the nine month period ended September 30, 2008
includes the benefit of the reversal of a valuation allowance associated with a federal net
operating loss carry forward available to us in 2009 of approximately $750,000. During the second
quarter of 2008, we determined, based on taxable income for the six month period ended June 30,
2008 and anticipated income for 2008 and 2009, that it is more likely than not that these
deferred tax assets would be realized. The tax benefit resulting from the reversal of the valuation
reserve was partially offset by the impact of the difference for financial reporting and tax
purposes of deductions associated with stock-based compensation. We currently estimate that our
actual tax payments related to 2008 are expected to be paid at a rate of approximately 21%, as we
have access to $29.4 million of federal operating loss carryforwards and $157,000 of the federal
research and development credits to reduce our 2008 taxable income. This percentage is higher than
previously estimated because in September 2008, California suspended for two years the ability to
use state operating loss carryforwards and certain credit carryforwards to reduce taxable income.
We expect to use these state operating loss carryforwards and certain credit carryforwards after
the two year suspension. We made estimated tax payments of $8.2 million for the nine months ended
September 30, 2008 associated with our estimated 2008 tax obligations.
Net Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income |
|
$ |
24,290 |
|
|
$ |
3,149 |
|
|
$ |
21,141 |
|
|
|
671 |
% |
For the nine months ended September 30, 2008, we had net income of $24.3 million as compared
to $3.1 million for the nine months ended September 30, 2007, an increase of $21.1 million. The
increase resulted primarily from the implementation of our new strategy and business model for
Acthar.
Series A Preferred Stock Dividend and Distribution
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
September 30, |
|
Increase/ |
|
% |
|
|
2008 |
|
2007 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Deemed dividend on Series A Preferred Stock |
|
$ |
5,267 |
|
|
$ |
|
|
|
$ |
5,267 |
|
|
|
|
|
Allocation of undistributed earnings to Series A Preferred Stock |
|
$ |
|
|
|
$ |
95 |
|
|
$ |
(95 |
) |
|
|
(100 |
)% |
The deemed dividend resulted from the repurchase of our Series A Preferred Stock in February
2008. On February 19, 2008, we completed the repurchase of the outstanding 2,155,715 shares of
Series A Preferred Stock from Shire Pharmaceuticals, Inc. for cash consideration of $10.3 million
or $4.80 per share (the same price per
preferred share as the closing price per share of our common stock on February 19, 2008). As
of December 31, 2007, the Series A Preferred Stock had a carrying amount of $5.1 million as
reflected on the accompanying Consolidated Balance Sheet. The deemed dividend represents the
difference between the $10.3 million repurchase payment and the $5.1 million balance sheet carrying
value of the Series A Preferred Stock. The repurchase transaction had no income tax impact.
The $95,000 allocation of undistributed earnings to Series A Preferred Stock for the nine
month period ended September 30, 2007 represented an allocation of a portion of our net income for
the nine month period ended September 30, 2007 to the Series A Preferred Stock for purposes of
determining net income applicable to common shareholders. This is an accounting allocation only and
was not an actual distribution or obligation to distribute a portion of our net income for the nine
month period to the Series A stockholder.
27
Net Income Applicable to Common Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income applicable to common shareholders |
|
$ |
19,023 |
|
|
$ |
3,054 |
|
|
$ |
15,969 |
|
|
|
523 |
% |
For the nine months ended September 30, 2008, we had net income applicable to common
shareholders of $19.0 million, or $0.26 per fully diluted share, as compared to net income
applicable to common shareholders of $3.1 million, or $0.04 per share, for the nine months ended
September 30, 2007, an increase of $16.0 million. The increase resulted primarily from the
implementation of our new strategy and business model for Acthar. The $5.3 million reduction to net
income related to the deemed dividend on the repurchased Series A Preferred Stock reduced fully
diluted earnings per share applicable to common shareholders by $0.07.
Liquidity and Capital Resources
Prior to the implementation of our new strategy and business model for Acthar, we principally
funded our activities through various issuances of equity securities and debt and from the sale of
our non-core commercial product lines in October 2005. During the nine month period ended September
30, 2008, we generated $53.7 million in cash from operations resulting from the implementation of
our new Acthar strategy.
At September 30, 2008, we had cash, cash equivalents and short-term investments of $40.9
million compared to $30.2 million at December 31, 2007. The increase was due primarily to $53.7
million of cash generated from operations and $1.1 million in proceeds from the issuance of common
stock under our Employee Stock Purchase Plan and from the exercise of stock options, partially
offset by $35.6 million paid to repurchase our common stock and the $10.3 million ($4.80 per share)
paid to repurchase our Series A preferred stock in February 2008. At September 30, 2008, our
working capital was $41.9 million compared to $57.2 million at December 31, 2007. The decrease in
our working capital was principally due to a decrease in accounts receivable of $12.5 million, a
decrease in deferred tax assets of $7.1 million, and an increase of $5.8 million in sales-related
reserves resulting primarily from increased Medicaid rebate reserves, partially offset by the $10.7
million increase in cash, cash equivalents and short-term investments as of September 30, 2008. The
decrease in accounts receivable resulted primarily from the change of payment terms from 60 days to
30 days under our amended distribution agreement with CuraScript.
In March 2008, we announced that our board of directors approved a stock repurchase plan that
provides for our repurchase of up to 7 million of our common shares in either open market or
private transactions, which will occur from time to time and in such amounts as management deems
appropriate. To date, we have repurchased a total of 3,490,900 shares of our common stock for $15.6
million under our stock repurchase plan, at an average price of $4.46 per share.
In addition, on August 13, 2008, we completed a board-approved repurchase of 2,200,000 shares
of our common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal L.D.A., an entity owned
by Paolo Cavazza and members of his family, for $10.9 million or $4.95 per share. On September 3,
2008, we completed a board-approved repurchase of an additional 1,800,000 shares of our common
stock from Inverlochy
Consultadorio & Servicos L.D.A., an entity owned by Claudio Cavazza, for $9.1 million or $5.06
per share. Both repurchases were made outside of our existing share repurchase plan.
In April 2008, we announced the amendment of our distribution agreement with CuraScript. The
amendment became effective on June 1, 2008. Under the amended agreement, the payment terms have
been reduced from 60 days to 30 days. The reduction in payment terms reduced our accounts
receivable balance and generated a one-time increase in our cash balance during the third quarter
of 2008 of approximately $10 million.
We lease a 30,000 square foot facility in Hayward, California. Our master lease on the Hayward
facility expires in November 2012. As of September 30, 2008, we were obligated to pay rent on the
Hayward facility of $3.6 million and to pay our share of insurance, taxes and common area
maintenance through the expiration of the master lease. Effective November 1, 2007, we subleased
5,000 square feet of the facility through April 2009 and effective February 1, 2008 we subleased
the remaining 25,000 square feet through the remainder of the term of the master lease. These
subleases cover a portion of our lease commitment, and all of our insurance, taxes and common area
maintenance.
Recently Issued Accounting Standards
See Note 12, Recently Issued Accounting Standards, in the notes to the consolidated
financial statements for a discussion of recent accounting pronouncements.
28
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at September 30, 2008 has not changed materially from December 31,
2007, and reference is made to the more detailed disclosures of market risk included in our Annual
Report on Form 10-K for the year ended December 31, 2007.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure.
In designing and evaluating the disclosure controls and procedures, management recognizes that
any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and management is required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our
disclosure controls and procedures were designed to provide reasonable assurance that the controls
and procedures would meet their objectives.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level.
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Not applicable
ITEM 1A. RISK FACTORS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and
uncertainties. The Companys actual results could differ materially from those discussed herein.
Factors that could cause or contribute to such differences include, but are not limited to:
|
|
|
the Companys ability to continue to successfully implement its business strategy for Acthar; |
|
|
|
|
the introduction of competitive products; |
|
|
|
|
regulatory changes, including possible outcomes relating to a July 2008 Congressional
hearing regarding orphan drug pricing; |
|
|
|
|
the Companys ability to accurately forecast the
demand for its products; |
|
|
|
|
the gross margin achieved from the sale of the Companys products; |
|
|
|
|
the Companys ability to estimate the quantity of Acthar used by government-supported
entities and Medicaid-eligible patients; |
29
|
|
|
that the actual amount of rebates and discounts related to the use of Acthar by
government-supported entities and Medicaid-eligible patients may differ materially from the
Companys estimates; |
|
|
|
|
the expenses and other cash needs for upcoming periods; |
|
|
|
|
the inventories carried by the Companys distributors, specialty pharmacies and hospitals; |
|
|
|
|
volatility in the Companys monthly and quarterly Acthar shipments and end-user demand; |
|
|
|
|
the Companys ability to obtain finished goods from its sole source contract manufacturers on
a timely basis if at all; |
|
|
|
|
the Companys ability to retain key management personnel; |
|
|
|
|
the
Companys ability to utilize its net operating loss carryforwards to reduce income taxes on
taxable income; |
|
|
|
|
research and development risks, including risks associated with the Companys sNDA for IS, its
preliminary work in the area of Nephrotic Syndrome and QSC-001; |
|
|
|
|
uncertainties regarding the Companys intellectual property; |
|
|
|
|
the uncertainty of receiving required regulatory approvals in a timely way, or at all; |
|
|
|
|
uncertainties in the credit and capital markets and the impact a further deterioration of
these markets could have on the Companys investment portfolio; |
|
|
|
|
the failure to maintain an adequate level of reimbursement for Acthar from third
party payors; |
|
|
|
|
the Companys ability to enforce its product returns policy; |
|
|
|
|
the
outsourcing of the Companys Acthar distribution functions to CuraScript; |
|
|
|
|
the
sell-through by the Companys distributors; |
|
|
|
|
the Companys ability to maintain an
effective system of internal controls; |
|
|
|
|
that product liability lawsuits could be successfully brought against the Company or the
Company becomes subject to other forms of litigation; and |
|
|
|
|
other research, development, and regulatory risks. |
These and other risks are described in Part I, Item 1A of the Companys Annual Report on Form
10-K for the year ended December 31, 2007.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Issuer Purchases of Equity Securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number |
|
Maximum Number |
|
|
|
|
|
|
Average |
|
Of Shares Purchased |
|
Of Shares That May |
|
|
Total Number |
|
Price |
|
as Part of |
|
Yet be Purchased |
|
|
of Shares |
|
Paid per |
|
Publicly Announced |
|
Under the Plans or |
Period |
|
Purchased |
|
Share |
|
Plans or Programs |
|
Programs |
July 1 July 31, 2008 |
|
|
587,000 |
|
|
$ |
4.96 |
|
|
|
587,000 |
|
|
|
3,672,100 |
|
August 1 August 31, 2008 |
|
|
2,351,700 |
|
|
$ |
4.96 |
|
|
|
151,700 |
|
|
|
3,520,400 |
|
September 1 September 30, 2008 |
|
|
1,811,300 |
|
|
$ |
5.06 |
|
|
|
11,300 |
|
|
|
3,509,100 |
|
|
Total |
|
|
4,750,000 |
|
|
$ |
5.00 |
|
|
|
750,000 |
|
|
|
|
|
30
On February 29, 2008, the Companys board of directors approved a stock repurchase plan that
provides for the Companys repurchase of up to 7 million of its common shares. The stock repurchase
plan was publicly announced on March 3, 2008. Stock repurchases under this program may be made
through open market or privately negotiated transactions in accordance with all applicable laws,
rules and regulations. The transactions may be made from time to time and in such amounts as
management deems appropriate and will be funded from available working capital. The stock
repurchase program does not have an expiration date and may be limited or terminated at any time by
the board of directors without prior notice. To date, the Company has repurchased a total of
3,490,900 shares of its common stock for $15.6 million under its stock repurchase plan.
On August 13, 2008, the Company completed a board-approved repurchase of 2,200,000 shares of
its common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal L.D.A., an entity owned by
Paolo Cavazza and members of his family, for $10.9 million or $4.95 per share. On September 3,
2008, the Company completed a board-approved repurchase of an additional 1,800,000 shares of its
common stock from Inverlochy Consultadorio & Servicos L.D.A., an entity owned by Claudio Cavazza,
for $9.1 million or $5.06 per share. Both repurchases were made outside of the Companys existing
share repurchase plan.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable
ITEM 5. OTHER INFORMATION
Not applicable
ITEM 6. EXHIBITS
|
|
|
Exhibit No |
|
Description |
31.1
|
|
Certification pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
31.2
|
|
Certification pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
32.1*
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
32.2*
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
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* |
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These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
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 hereunto duly authorized.
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QUESTCOR PHARMACEUTICALS, INC.
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Date: November 12, 2008 |
By: |
/s/ Don M. Bailey
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Don M. Bailey |
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President and Chief Executive Officer |
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By: |
/s/ Gary Sawka
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Gary Sawka |
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Senior Vice President, Finance and
Chief Financial Officer |
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32
Exhibit Index
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Exhibit No |
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Description |
31.1
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Certification pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
31.2
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Certification pursuant to Rule 13a-14 under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
32.1*
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
32.2*
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002. |
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* |
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These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not
being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any
filing of Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation
language in such filing. |
exv31w1
EXHIBIT 31.1
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Don M.
Bailey, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor
Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
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a) |
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designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared; |
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b) |
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designed such internal controls over financial reporting, or caused such internal control over
financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles; |
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c) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and |
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d) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, the registrants internal control over
financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
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a) |
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all significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrants
ability to record, process,
summarize and report financial information; and |
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b) |
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any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting. |
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Date: November 12, 2008 |
/s/ Don M. Bailey
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Don M. Bailey |
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Chief Executive Officer |
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exv31w2
EXHIBIT 31.2
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Gary Sawka, certify
that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor
Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
|
a) |
|
designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by others within
those entities, particularly during the period in which this report is being prepared; |
|
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b) |
|
designed such internal controls over financial reporting, or caused such internal control over
financial reporting to be designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles; |
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c) |
|
evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and |
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d) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has materially
affected, or is reasonably likely to materially affect, the registrants internal control over
financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
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a) |
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all significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrants
ability to record, process, summarize and report financial information; and |
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b) |
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any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting. |
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Date: November 12, 2008 |
/s/ Gary Sawka
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Gary Sawka |
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Chief Financial Officer |
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exv32w1
EXHIBIT 32.1
Certification
On
November 12, 2008, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2008 (the Form 10-Q) with the Securities and Exchange
Commission. Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of
2002, the undersigned hereby certify, to such persons knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2008 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Dated: November 12, 2008 |
/s/ Don M. Bailey
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Don M. Bailey |
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Chief Executive Officer |
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The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.
exv32w2
EXHIBIT 32.2
Certification
On
November 12, 2008, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q
for the quarter ended September 30, 2008 (the Form 10-Q) with the Securities and Exchange
Commission. Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of
2002, the undersigned hereby certify, to such persons knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2008 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Dated: November 12, 2008 |
/s/ Gary Sawka
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Gary Sawka |
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Chief Financial Officer |
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The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.