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 MARCH 31, 2009
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
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33-0476164 |
(State or other jurisdiction
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(I.R.S. Employer of |
of incorporation or organization)
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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 has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit
and post such files). Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See 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 þ | Non-accelerated filer o (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 May 7, 2009 there were 64,417,413 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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March 31, |
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December 31, |
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2009 |
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2008 |
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(Unaudited) |
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(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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$ |
9,661 |
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$ |
13,282 |
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Short-term investments |
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51,399 |
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42,169 |
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Total cash, cash equivalents and short-term investments |
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61,060 |
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55,451 |
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Accounts receivable, net of allowance for doubtful accounts of $46 and $62 at
March 31, 2009 and December 31, 2008, respectively |
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8,853 |
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10,418 |
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Inventories, net |
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2,487 |
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2,459 |
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Prepaid income taxes |
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356 |
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3,316 |
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Prepaid expenses and other current assets |
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1,219 |
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1,101 |
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Deferred tax assets |
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6,154 |
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6,252 |
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Total current assets |
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80,129 |
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78,997 |
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Property and equipment, net |
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435 |
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450 |
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Purchased technology, net |
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3,595 |
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3,669 |
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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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710 |
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710 |
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Deferred tax assets |
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5,021 |
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5,021 |
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Total assets |
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$ |
90,189 |
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$ |
89,146 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
4,303 |
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$ |
4,302 |
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Accrued compensation |
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966 |
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1,896 |
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Sales-related reserves |
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12,332 |
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11,825 |
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Other accrued liabilities |
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1,152 |
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1,702 |
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Total current liabilities |
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18,753 |
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19,725 |
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Lease termination and deferred rent liabilities and other non-current liabilities |
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1,451 |
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1,529 |
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Total liabilities |
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20,204 |
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21,254 |
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Shareholders equity: |
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Preferred stock, no par value, 7,500,000 shares authorized; none outstanding |
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Common stock, no par value, 105,000,000 shares authorized; 64,610,130 and
65,970,653 shares issued and outstanding at March 31, 2009 and December 31,
2008, respectively |
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78,552 |
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84,028 |
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Accumulated deficit |
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(8,731 |
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(16,405 |
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Accumulated other comprehensive income |
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164 |
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269 |
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Total shareholders equity |
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69,985 |
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67,892 |
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Total liabilities and shareholders equity |
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$ |
90,189 |
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$ |
89,146 |
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See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF INCOME
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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Net sales |
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$ |
23,298 |
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$ |
19,132 |
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Cost of sales (exclusive of amortization of purchased technology) |
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1,510 |
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1,319 |
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Gross profit |
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21,788 |
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17,813 |
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Operating expenses: |
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Selling, general and administrative |
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7,253 |
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5,066 |
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Research and development |
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2,456 |
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1,971 |
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Depreciation and amortization |
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118 |
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122 |
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Total operating expenses |
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9,827 |
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7,159 |
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Income from operations |
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11,961 |
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10,654 |
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Other income: |
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Interest income |
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267 |
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364 |
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Other income, net |
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1 |
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11 |
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Gain on sale of product rights |
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25 |
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Total other income |
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293 |
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375 |
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Income before income taxes |
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12,254 |
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11,029 |
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Income tax expense |
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4,580 |
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4,488 |
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Net income |
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7,674 |
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6,541 |
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Deemed dividend on Series A preferred stock |
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5,267 |
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Net income applicable to common shareholders |
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$ |
7,674 |
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$ |
1,274 |
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Net income per share applicable to common shareholders: |
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Basic |
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$ |
0.12 |
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$ |
0.02 |
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Diluted |
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$ |
0.11 |
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$ |
0.02 |
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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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65,498 |
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69,946 |
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Diluted |
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67,963 |
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74,103 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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OPERATING ACTIVITIES |
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Net income |
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$ |
7,674 |
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$ |
6,541 |
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Adjustments to reconcile net income to net cash provided by operating activities: |
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Share-based compensation expense |
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1,045 |
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1,933 |
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Deferred income taxes |
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4,488 |
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Amortization of investments |
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(43 |
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(209 |
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Depreciation and amortization |
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118 |
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122 |
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Gain on sale of product rights |
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(25 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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1,565 |
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5,745 |
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Inventories |
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(28 |
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17 |
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Prepaid income taxes |
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2,960 |
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(366 |
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Prepaid expenses and other current assets |
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(118 |
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(378 |
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Accounts payable |
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1 |
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971 |
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Accrued compensation |
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(930 |
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(1,162 |
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Sales-related reserves |
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507 |
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1,831 |
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Income taxes payable |
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(1,303 |
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Other accrued liabilities |
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(550 |
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(316 |
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Other non-current liabilities |
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(78 |
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(147 |
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Net cash flows provided by operating activities |
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12,098 |
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17,767 |
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INVESTING ACTIVITIES |
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Purchase of property and equipment |
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(29 |
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(6 |
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Purchase of short-term investments |
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(24,193 |
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(13,341 |
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Proceeds from the sale and maturities of short-term investments |
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15,000 |
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6,186 |
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Proceeds from sale of product rights |
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25 |
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Changes in deposits and other assets |
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(4 |
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Net cash flows used in investing activities |
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(9,197 |
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(7,165 |
) |
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FINANCING ACTIVITIES |
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Issuance of common stock, net |
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250 |
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378 |
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Repurchase of Series A preferred stock |
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(10,348 |
) |
Repurchase of common stock |
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(6,772 |
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(6,201 |
) |
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Net cash flows used in financing activities |
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(6,522 |
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(16,171 |
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Decrease in cash and cash equivalents |
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(3,261 |
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(5,569 |
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Cash and cash equivalents at beginning of period |
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13,282 |
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15,939 |
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Cash and cash equivalents at end of period |
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$ |
9,661 |
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$ |
10,370 |
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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 H.P. Acthar® Gel (repository corticotropin injection), 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. H.P. Acthar Gel (Acthar) is not indicated for, but is also 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. The Company also
markets Doral® (quazepam), which is indicated for the treatment of insomnia
characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning
awakenings.
In August 2007, the Company announced its Acthar-centric business strategy, which included a
new pricing level for Acthar effective August 27, 2007. The strategy was adopted in order to best
position Acthar to benefit patients, advance the Companys product development programs and ensure
that the Company become economically viable. Since the adoption of the strategy, the Company has
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 have established
a group of representatives 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, 2008. The accompanying consolidated
balance sheet at December 31, 2008 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, 2009 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.
6
2. REVENUE RECOGNITION
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 and risk of loss transfer at the point of receipt by the customer. If
the title to the product and risk of loss transfer at the point of shipment, revenue is recognized upon shipment of
the product. The Company estimates reserves for product returns from
its specialty distributor, wholesalers, hospitals and pharmacies; government chargebacks for sales
of its products by wholesalers and its 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 the Companys
sales of Doral. The Company estimates its reserves by utilizing historical information 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 the Companys reserves for product returns, government chargebacks, and Medicaid
rebates. The Company believes that the assumptions used to estimate these sales reserves are
reasonable considering known facts and circumstances. However, the Companys product returns,
government chargebacks, and Medicaid rebates could differ significantly from its estimates because
the Companys analysis of product shipments, prescription trends, the amount of product in the
distribution channel, and its interpretation of the Medicaid statute and regulations, may not be
accurate. If actual product returns, government chargebacks, and Medicaid rebates are significantly
different from the Companys estimates, or if the Companys customers fail to adhere to its expired
product returns policy, such differences would be accounted for in the period in which they become
known. To date, actual amounts have generally been consistent with the Companys estimates.
The Company utilizes the services of CuraScript, Inc. which has a specialty distributor
subsidiary, CuraScript Specialty Distribution, Inc. (CuraScript SD) and a group of specialty
pharmacies (CuraScript SP). During July 2007, the Company began utilizing CuraScript SD 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 SD. The Company sells Acthar to CuraScript SD at a discount from the Companys list
price. CuraScript SD sells Acthar primarily to hospitals and specialty pharmacies. Product sales
are recognized net of this discount upon receipt of the product by CuraScript SD. In April 2008,
the Company announced the amendment of its distribution agreement with CuraScript SD, which became
effective on June 1, 2008. Under the new terms, the discount provided by the Company to CuraScript
SD is reduced from $1,047 per vial to $230 per vial. The new discounted sales price to CuraScript
SD is $23,039 per vial and the stated list price remains at $23,269. However, under the new terms
the pricing to CuraScript SD customers is unchanged. The amount of the discount to CuraScript SD 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 SD. Under
the Companys distribution agreement with CuraScript SD, if the price of Acthar is reduced,
CuraScript SD will receive a shelf-stock adjustment credit based upon the amount of product in
their inventory at the time of the price reduction. Any reduction in the selling price of Acthar is
at the Companys discretion. To date, there have been no such price reductions. 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.
The Company will supply replacement product to CuraScript SD 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.
As required by federal regulations, the Company provides a rebate related to product dispensed
to Medicaid eligible patients. The Companys a) estimated 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 the period as follows:
7
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a) |
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The estimated liability included in sales-related reserves as of the end of a period is
comprised of the estimated rebate units associated with end user demand data 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. |
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b) |
|
In order to assess current and future rates of Medicaid utilization, the Company analyzes
inventory levels received from a third party, CuraScript SD, and patient prescription data
received from a third party, CuraScript SP. |
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 SD. The Medicaid rebates associated with end user
demand for a period are generally paid to the states by the end of the quarter following the
quarter in which the rebate estimated reserve is established.
Certain government-supported entities are permitted to purchase Acthar from CuraScript SD and
Doral from wholesalers for a nominal amount. CuraScript SD and the wholesalers 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 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. Chargebacks are generally applied
by customers against their payments to the Company approximately 30 to 45 days after the customers
have provided appropriate documentation to confirm their sale to a qualified government-supported
entity.
For sales of Doral, the Company grants 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 March 31, 2009 and December 31, 2008, sales-related reserves included in the accompanying
Consolidated Balance Sheets were as follows (in thousands):
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|
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March 31, |
|
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December 31, |
|
|
|
2009 |
|
|
2008 |
|
Medicaid rebates |
|
$ |
12,044 |
|
|
$ |
11,406 |
|
Government chargebacks |
|
|
42 |
|
|
|
164 |
|
Product returns credit memoranda policy |
|
|
212 |
|
|
|
218 |
|
Product returns product replacement policy |
|
|
34 |
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
$ |
12,332 |
|
|
$ |
11,825 |
|
|
|
|
|
|
|
|
8
3. SHARE-BASED COMPENSATION
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 |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Cost of sales |
|
$ |
|
|
|
$ |
|
|
Selling, general and administrative |
|
|
867 |
|
|
|
1,644 |
|
Research and development |
|
|
151 |
|
|
|
233 |
|
|
|
|
|
|
|
|
Total |
|
$ |
1,018 |
|
|
$ |
1,877 |
|
|
|
|
|
|
|
|
4. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
A summary of cash equivalents and short-term investments, classified as available-for-sale,
and carried at fair value is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Gain |
|
|
(Loss) |
|
|
Fair Value |
|
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
7,064 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
7,064 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
21,461 |
|
|
$ |
169 |
|
|
$ |
|
|
|
$ |
21,630 |
|
Government-sponsored enterprises |
|
|
25,940 |
|
|
|
56 |
|
|
|
|
|
|
|
25,996 |
|
Municipal bonds |
|
|
3,737 |
|
|
|
36 |
|
|
|
|
|
|
|
3,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
51,138 |
|
|
$ |
261 |
|
|
$ |
|
|
|
$ |
51,399 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
10,293 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
10,293 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
7,830 |
|
|
$ |
59 |
|
|
$ |
|
|
|
$ |
7,889 |
|
Governmentsponsored enterprises |
|
|
30,309 |
|
|
|
210 |
|
|
|
|
|
|
|
30,519 |
|
Municipal bonds |
|
|
3,762 |
|
|
|
|
|
|
|
(1 |
) |
|
|
3,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
41,901 |
|
|
$ |
269 |
|
|
$ |
(1 |
) |
|
$ |
42,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2009, the average contractual maturity of the Companys short-term investments
was approximately 8 months.
Fair Value
Effective January 1, 2008, the Company adopted Statement of Financial Accounting Standards
(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 SFAS No. 157 framework clarifies that fair
value is an exit price, representing the amount that would be received to sell an asset or the
amount paid to transfer a liability in an orderly transaction between market participants. As such,
fair value is a market-based measurement that should be determined based on assumptions that market
participants would use in pricing an asset or liability.
As a basis for considering such assumptions, SFAS No. 157 establishes a three-tier value
hierarchy, which prioritizes the inputs used in measuring fair value as follows: (Level 1)
observable inputs such as quoted market prices in active markets; (Level 2) inputs other than
quoted prices in active markets that are observable either directly or indirectly; and (Level 3)
unobservable inputs in which there is little or no market data, which require the Company to
develop its own assumptions. This hierarchy requires the Company to use observable market data,
when available, and to minimize the use of unobservable inputs when determining fair value. On a
recurring basis, the Company measures its marketable debt securities at fair value. The Companys
fair market value measurements utilize either quoted prices in active markets (Level 1) or prices
using readily observable inputs (Level 2) for all of its short-term investments, and are as a result
valued at either the Level 1 or Level 2 fair value hierarchy as defined in SFAS No. 157.
9
The following methods and assumptions were used to determine the fair value of each class of
assets and liabilities recorded at fair value in the consolidated balance sheets:
Cash equivalents: Cash equivalents primarily consist of highly rated money market funds with
maturities of one year or less, and are purchased daily at par value with specified yield rates.
Due to the high ratings and short-term nature of these funds, the Company considers all cash
equivalents as Level 1 inputs.
Short-term available-for-sale investments at fair value: Fair values are based on quoted
market prices, where available. These fair values are obtained from third party pricing services,
which generally use Level 1 or Level 2 inputs for the determination of fair value in accordance
with SFAS No. 157. Third party pricing services normally derive the security prices through
recently reported trades for identical or similar securities making adjustments through the
reporting date based upon available market observable information. For securities not actively
traded, the third party pricing services may use quoted market prices of comparable instruments or
discounted cash flow analyses, incorporating inputs that are currently observable in the markets
for similar securities.
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 March 31, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basis of Fair Value Measurements |
|
|
|
|
|
|
|
Quoted prices |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
in active |
|
|
other |
|
|
Significant |
|
|
|
Balance at |
|
|
markets for |
|
|
observable |
|
|
unobservable |
|
|
|
March 31, |
|
|
identical items |
|
|
inputs |
|
|
inputs |
|
|
|
2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Money market funds |
|
$ |
7,064 |
|
|
$ |
7,064 |
|
|
$ |
|
|
|
|
|
|
Commercial paper |
|
|
21,630 |
|
|
|
|
|
|
|
21,630 |
|
|
|
|
|
Government-sponsored enterprises |
|
|
25,996 |
|
|
|
|
|
|
|
25,996 |
|
|
|
|
|
Municipal bonds |
|
|
3,773 |
|
|
|
|
|
|
|
3,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
58,463 |
|
|
$ |
7,064 |
|
|
$ |
51,399 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certain
assets and liabilities are measured at fair value on a nonrecurring basis; that is, the
instruments are not measured at fair value on an ongoing basis but are subject to fair value
adjustments only in certain circumstances (for example, when there is evidence of impairment).
There were no assets or liabilities measured at fair value on a nonrecurring basis during the
three months ended March 31, 2009.
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist
of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Raw materials |
|
$ |
2,202 |
|
|
$ |
2,056 |
|
Finished goods |
|
|
314 |
|
|
|
432 |
|
Less allowance for excess and obsolete inventories |
|
|
(29 |
) |
|
|
(29 |
) |
|
|
|
|
|
|
|
|
|
$ |
2,487 |
|
|
$ |
2,459 |
|
|
|
|
|
|
|
|
6. PURCHASED TECHNOLOGY
Purchased technology at March 31, 2009 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 $791,000 as of March 31, 2009.
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. In May 2009, the Company entered into a three-month extension of the sublease of the 5,000
square foot portion of the facility. 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 Income. As of March 31, 2009, the Company is
obligated to pay rent on the Hayward facility of $3.2 million. Over the remaining term of the
master lease the Company anticipates that it will receive approximately $1.5 million in sublease
income to be used to pay a portion of its Hayward facility obligation. As of March 31, 2009 and
December 31, 2008, the estimated liability related to the Hayward facility totaled $1.1 million and
$1.2 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
10
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 March 31,
2009 and December 31, 2008.
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. On February 25, 2009, the Company received a Civil Investigative
Demand (CID) from the Attorney General of the State of Missouri, in connection with
its investigation into the Companys pricing practices with respect to Acthar under Missouris
Merchandising Practices Act. On May 7, 2009, the Company received a subpoena from the Attorney
General of the State of New York, in connection with its investigation, under New Yorks
antitrust statute and Federal antitrust statutes, into the Companys acquisition of Acthar
from Aventis in 2001, the Companys Acthar royalty arrangements and its subsequent
pricing of Acthar. The Company has produced documents and information to the Attorney General
of Missouri, and intends to produce documents and information to the Attorney General of New York.
The Company intends to cooperate with those offices, as it has with respect to government
inquiries of all types.
Management
is not currently aware of any claims or other legal matters that will have a material adverse
affect on the financial position, results of operations or cash flows of the Company.
8. NET INCOME PER SHARE
The Company computes basic net income per share applicable to common shareholders by dividing net income
applicable to common shareholders 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.
11
The following table presents the amounts and shares used in computing basic and diluted net
income per share applicable to common shareholders for the three month periods ended March 31, 2009
and 2008, and the effect of dilutive potential common shares on the number of shares used in
computing diluted net income per share applicable to common shareholders. Dilutive 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 |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Net income applicable to common shareholders |
|
$ |
7,674 |
|
|
$ |
1,274 |
|
|
|
|
|
|
|
|
Shares used in computing net income per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
Basic |
|
|
65,498 |
|
|
|
69,946 |
|
Effect of dilutive potential common shares: |
|
|
|
|
|
|
|
|
Stock options |
|
|
2,449 |
|
|
|
3,773 |
|
Restricted stock |
|
|
16 |
|
|
|
32 |
|
Warrants |
|
|
|
|
|
|
352 |
|
|
|
|
|
|
|
|
Diluted |
|
|
67,963 |
|
|
|
74,103 |
|
|
|
|
|
|
|
|
Net income per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.12 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.11 |
|
|
$ |
0.02 |
|
|
|
|
|
|
|
|
The following table presents the shares 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 |
|
|
March 31, |
|
|
2009 |
|
2008 |
Stock options |
|
|
2,347 |
|
|
|
1,127 |
|
Restricted stock |
|
|
|
|
|
|
233 |
|
Series A Preferred Stock |
|
|
|
|
|
|
2,156 |
|
9. INCOME TAXES
Income tax expense for the three month periods ended March 31, 2009 and 2008 was $4.6 million
and $4.5 million, respectively. For the three month periods ended March 31, 2009 and 2008, the
Companys effective tax rate for financial reporting purposes was approximately 37.4% and 41%,
respectively. The decrease in the Companys effective income tax rate results primarily from lower
nondeductible share-based compensation expense and lower state income taxes in 2009.
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 |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Net income |
|
$ |
7,674 |
|
|
$ |
6,541 |
|
Change in unrealized gains on available-for-sale securities, net of related tax effects |
|
|
(105 |
) |
|
|
25 |
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
7,569 |
|
|
$ |
6,566 |
|
|
|
|
|
|
|
|
11. EQUITY TRANSACTIONS
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. During the quarter ended March 31, 2009
the Company repurchased 1,344,900 shares of its common stock at an average price of $5.04 per share,
for a purchase price of $6.8 million. Through March 31, 2009, the Company had repurchased a total
of 4,835,800 shares of its common stock for $22.3 million under its stock repurchase plan, at an average price
of $4.62 per share (see Note 14 Subsequent Events).
12
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 Statements of Income.
13
12. RECENTLY ISSUED ACCOUNTING STANDARDS
In April 2009, the Financial Accounting Standards Board (FASB) issued FASB Staff Position
(FSP) FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary Impairments
(FSP 115-2 and FSP 124-2). FSP 115-2 and FSP 124-2 are intended to provide greater clarity to
investors about the credit and noncredit component of an other-than-temporary impairment event and
to more effectively communicate when an other-than-temporary impairment event has occurred. FSP
115-2 and FSP 124-2 apply to fixed maturity securities only and require separate display of losses
related to credit deterioration and losses related to other market factors. When an entity does not
intend to sell the security and it is more likely than not that an entity will not have to sell the
security before recovery of its cost basis, it must recognize the credit component of an
other-than-temporary impairment in earnings and the remaining portion in other comprehensive
income. In addition, upon adoption of FSP 115-2 and FSP 124-2, an entity will be required to record
a cumulative-effect adjustment as of the beginning of the period of adoption to reclassify the
noncredit component of a previously recognized other-than-temporary impairment from retained
earnings to accumulated other comprehensive income. FSP 115-2 and FSP 124-2 will be effective for
the Company for the quarter ending June 30, 2009. The Company is currently evaluating the impact of
adopting FSP 115-2 and FSP 124-2.
In April 2009, the FASB issued FSP FAS 157-4, Determining Fair Value When the Volume and Level
of Activity for the Asset or Liability Have Significantly Decreased and Identifying Transactions
That Are Not Orderly (FSP 157-4). FSP 157-4 provides additional authoritative guidance to assist
both issuers and users of financial statements in determining whether a market is active or
inactive, and whether a transaction is distressed. FSP 157-4 will be effective for the Company for
the quarter ending June 30, 2009. The Company does not expect the adoption of FSP 157-4 to have a
material impact on its consolidated financial position and results of operations.
In April 2009, the FASB issued FSP FAS 107-1 and APB 28-1, Interim Disclosures about Fair
Value of Financial Instruments (FSP 107-1 and APB 28-1). FSP 107-1 and APB 28-1 require
disclosures about fair value of financial instruments for interim reporting periods of publicly
traded companies as well as in annual financial statements. FSP 107-1 and APB 28-1 will be
effective for the Company for the quarter ending June 30, 2009. The adoption of FSP 107-1 and APB
28-1 will not have an impact on the Companys consolidated financial position and results of
operations.
In February 2008, the FASB issued FSP FAS 157-2, Effective Date of FASB Statement No. 157
(FSP FAS 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 157-2. The adoption of FSP FAS 157-2 did not have a material
impact on the Company's consolidated
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 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 adoption of EITF 07-1 did not have a
material impact on the Company's consolidated
financial position and results of operations.
14
13. RELATED PARTY TRANSACTIONS
An immediate family member of the Companys CEO provided certain consulting services to the
Company totaling $18,000 for the three month period ended March 31, 2009. In addition, an
immediate family member of one of the Companys Vice Presidents is a Senior Vice President for a
company that provided certain consulting services to the Company totaling $42,000 for the three
month period ended March 31, 2009.
14. SUBSEQUENT EVENTS
From
April 1, 2009 through May 7, 2009, the Company repurchased
210,000 shares of its common stock
at an average price of $4.44 per share, for a total purchase price of
$933,000 under its stock repurchase
program approved by the Companys board of directors in February 2008.
On
May 7, 2009, the Company received a subpoena from the Attorney General of the State of New York,
in connection with its investigation into the Companys acquisition of Acthar from Aventis in
2001, the Companys Acthar royalty arrangements and its subsequent pricing of Acthar
(See Note 7 Commitments, Indemnifications and Contingencies).
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, 2008, 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 market H.P. Acthar Gel (repository corticotropin injection), 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. H.P. Acthar Gel (Acthar) is not indicated for, but is also 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. We also market Doral
(quazepam), which is indicated for the treatment of insomnia characterized by difficulty in falling
asleep, frequent nocturnal awakenings, and/or early morning awakenings.
In August 2007, we announced our Acthar-centric business strategy, which included a new
pricing level for Acthar effective August 27, 2007. The strategy was adopted in order to best
position Acthar to benefit patients, advance our product development programs and ensure that the
company become economically viable. Since the adoption of the strategy, we have 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 have established a group of
representatives and medical science liaisons to work with healthcare providers who administer
Acthar. We continue to support the Acthar patient assistance programs, administered by the
National Organization for Rare Disorders (NORD). These and other support programs have now
provided both co-pay financial assistance and free drug with commercial value of over $26 million
to patients since September 2007. As a result of these efforts, we are not aware of a single
patient in the United States who needed 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, despite the deterioration of the
current U.S. economic environment. 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. As a result of these
initiatives, which have been made possible by our change in strategy, we expect to fund more than a
dozen new pre-clinical and clinical studies in 2009.
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. Pursuant to
guidelines published by the American Academy of Neurology and the Child Neurology Society, many
child neurologists use Acthar to treat infants afflicted with IS even though it is not approved for
this indication. In March 2009, we submitted our supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) to add the treatment of infantile spasms to the list of
approved indications on the Acthar label. If the sNDA is approved, such
15
approval could require various actions by Questcor, including modification of the existing
Acthar label and/or the adoption of FDA-mandated risk evaluation and mitigation strategies.
Previously, the FDA granted Orphan Designation to the active ingredient in Acthar for the treatment
of IS. As a result of this Orphan Designation, if we are successful in obtaining FDA approval for
the IS indication, we will also qualify for tax credits for certain clinical testing expenses and
for a seven-year exclusivity period during which the FDA is prohibited from approving any other
adrenocorticotropic hormone (ACTH) formulation for IS unless the other formulation is demonstrated
to be clinically superior to Acthar or is considered by the FDA to have an active ingredient that
is different from the active ingredient of Acthar.
In the first quarter of 2009, we completed the initial phase of our previously announced MS
sales force expansion plan, hiring and training our sales force as well as completing all
territorial realignments. Our expanded sales force of 30 representatives will allow us to build
upon continued positive growth trends in prescriptions of Acthar for the treatment of exacerbations
associated with MS, an indication for which Acthar is already approved. Depending upon the success
of this first phase of our sales force expansion, a second phase of our sales force expansion to
approximately 40 representatives could occur later in 2009.
From
January 1, 2009 through May 7, 2009, we have repurchased a
total of 1,554,900 shares of our
common stock for $7.7 million under our stock repurchase plan, at
an average price of $4.96 per share.
As of May 7, 2009, there are 1,954,200 shares remaining under the stock repurchase plan approved by our
board of directors in February 2008. During 2008 we returned approximately $46 million to
shareholders through our common and preferred stock buyback efforts.
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 as compared to periods prior to the Acthar-centric business strategy
implementation. 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 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 the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or
conditions. 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 month periods ended March 31, 2009 and 2008, we have estimated reserves for
product returns from our specialty distributor, wholesalers, hospitals and pharmacies; Medicaid
rebates to all states for products dispensed to patients covered by Medicaid; government
chargebacks for sales of our products by wholesalers and our specialty distributor to certain
Federal government organizations including such organizations as the Veterans Administration; 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, Medicaid rebates, and government chargebacks. We
believe that the assumptions used to estimate these sales reserves are reasonable considering known
facts and circumstances. However, our product returns, Medicaid rebates, and government chargebacks
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, Medicaid
rebates, and
16
government chargebacks 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.
Product Returns
During July 2007, we began utilizing CuraScript SD, 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 SD. We
sell Acthar to CuraScript SD at a discount from our list price. Gross product sales are recognized
net of this discount upon receipt of the product by CuraScript SD. In April 2008, we announced the
amendment to our distribution agreement with CuraScript SD, which became effective on June 1, 2008.
Under the new terms, the discount provided by us to CuraScript SD is reduced from $1,047 per vial
to $230 per vial. The new discounted sales price to CuraScript SD is $23,039 per vial and the
stated list price remains at $23,269. However, under the new terms the pricing to CuraScript SD
customers is unchanged. The amount of the discount to CuraScript SD 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 SD. Under our distribution
agreement with CuraScript SD, if the price of Acthar is reduced, CuraScript SD will receive a
shelf-stock adjustment credit based upon the amount of product in their inventory at the time of
the price reduction. Any reduction in the selling price of Acthar is at our discretion. To date,
there have been no such price reductions. We will supply replacement product to CuraScript SD 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 SD 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.
Medicaid Rebates
We provide a rebate related to product dispensed to Medicaid eligible patients. Our a)
estimated 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 liability included in sales-related reserves as of the end of a period is
comprised of the estimated rebate units associated with end user demand data 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 received from a third party, CuraScript SD, and patient prescription data received
from a third party, CuraScript SP. |
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 SD. Management believes that the information received from
17
CuraScript SD related to inventory levels and CuraScript SP related to prescription data is
reliable, but we are unable to independently verify the accuracy of such data. The Medicaid
rebates associated with end user demand for a period are generally paid to the states by the end of
the quarter following the quarter in which the rebate estimated reserve is established.
Government Chargebacks
Certain government-supported entities are permitted to purchase Acthar from CuraScript SD and
Doral from wholesalers for a nominal amount. CuraScript SD and the wholesalers 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.
Chargebacks are generally applied by customers against their payments to us approximately 30 to 45
days after they have provided appropriate documentation to confirm their sale to a qualified
government-supported entity.
We routinely assess our experience with Medicaid rebates and government chargebacks and adjust
the reserves accordingly. Revisions in the Medicaid rebate and chargeback estimates are charged to
income in the period in which the information that gives rise to the revision becomes known. 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 March 31, 2009 and December 31, 2008, sales-related reserves included in the accompanying
Consolidated Balance Sheets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Medicaid rebates |
|
$ |
12,044 |
|
|
$ |
11,406 |
|
Government chargebacks |
|
|
42 |
|
|
|
164 |
|
Product returns credit memoranda policy |
|
|
212 |
|
|
|
218 |
|
Product returns product replacement policy |
|
|
34 |
|
|
|
37 |
|
|
|
|
|
|
|
|
|
|
$ |
12,332 |
|
|
$ |
11,825 |
|
|
|
|
|
|
|
|
Inventories
As of March 31, 2009, our net raw material and finished goods inventories
totaled $2.5 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.
Intangible and Long-Lived Assets
As of March 31, 2009, our intangible and long-lived assets consisted of goodwill of $299,000
generated from a merger in 1999, net purchased technology of $3.6 million related to our
acquisition of Doral and $435,000 of net property and equipment. The costs related to our
acquisition of Doral are being amortized over an estimated life of 15 years. 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 or whenever events occur or
circumstances change that could indicate a possible impairment may have occurred. Our fair value
is compared to the carrying value
18
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 March 31, 2009, 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 month periods ended March 31, 2009 and
2008 based on the historical term of our stock option awards. 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 month periods ended March 31, 2009 and 2008 includes $1.0 million
and $1.9 million, respectively, of share-based compensation expense related to employees and
non-employee members of our board of directors.
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 March 31, 2009 and
December 31, 2008, the estimated liability related to the Hayward facility totaled $1.1 million and
$1.2 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. In May 2009,
we entered into a three-month extension of the sublease of the 5,000 square foot portion of the
facility. These subleases cover a portion of our lease commitment, and all of our insurance, taxes
and common area maintenance. As of March 31, 2009, we are obligated to pay rent on the Hayward
facility of $3.2 million. Over the remaining term of the master lease, we anticipate that we will
receive approximately $1.5 million in sublease income to be used to pay a portion of our Hayward
facility obligation.
19
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 Income.
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,
which is ultimately dependent upon us generating future taxable income. 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 considered 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.
In 2008, we reversed our remaining $5.2 million valuation allowance for deferred tax assets
that we believe will be recovered based on anticipated taxable income in 2009 and future years.
This reversal resulted in an income tax benefit of $750,000 and $4.4 million in the second and
fourth quarters of 2008, respectively, which reduced our income tax expense. Any changes in the
valuation allowance based upon our future assessment will result in an income tax expense if the
valuation allowance is increased.
At December 31, 2008, we had federal and state net operating loss carryforwards of $9.9
million and $16.8 million, respectively, and federal and California research and development tax
credits of $591,000 and $940,000, respectively. Federal net operating loss carryforwards totaling
$9.9 million are subject to annual limitations and will be available from 2009 through 2018, as a
result of federal ownership change limitations. Of this amount, $2.1 million of federal net
operating loss carryforwards are available to reduce our 2009 taxable income. State net operating
loss carryforwards totaling $16.8 million are subject to annual limitations and are available from
2009 through 2018. 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. The federal and state net operating loss carryforwards and the federal credit
carryforwards expire at various dates beginning in the years 2013 through 2026, if not utilized.
Results of Operations
Three months ended March 31, 2009 compared to the three months ended March 31, 2008:
Total Net Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net sales |
|
$ |
23,298 |
|
|
$ |
19,132 |
|
|
$ |
4,166 |
|
|
|
22 |
% |
Net sales for the three month periods ended March 31, 2009 and 2008 were comprised of net
sales of our neurology products Acthar and Doral. Net sales of Acthar for the three month period
ended March 31, 2009 totaled $23.1 million as compared to $18.9 million during the same period in
2008. The increase in net sales is due primarily to an increase in Acthar units shipped during the
first quarter of 2009 as compared to the first quarter of 2008. During the first quarter of 2009
we shipped 1,429 Acthar units to our specialty distributor as compared to 1,260 units shipped
during the first quarter of 2008. In addition, Medicaid rebate amounts as a percentage of gross
sales were lower for the three month period ended March 31, 2009 as compared to the same period in
2008.
20
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 month period ended March 31, 2009,
Acthar gross sales were reduced by approximately 30% to account for the estimated amount of
Medicaid rebates and government chargebacks, as compared to approximately 32% for the three month
period ended March 31, 2008.
A greater percentage of infants than adults are eligible for Medicaid, which results in fewer
MS patients than IS patients participating in the Medicaid program. As a result of an increased
proportion of MS to IS prescriptions in the first quarter of 2009, the Medicaid rebate amounts as a
percentage of gross sales were 26% in the first quarter of 2009 compared to 28% in the first
quarter of 2008. During the first quarter of 2009 we completed our MS sales force expansion. The
sales force expansion supports our increased sales efforts related to the use of Acthar for the
treatment of exacerbations associated with MS, an indication for which Acthar is already approved.
New MS prescriptions shipped in the first quarter of 2009 more than tripled from the first quarter
of 2008. New MS prescription activity in the first quarter of 2009 was similar to the activity in
the fourth quarter of 2008 as we engaged in our sales force expansion and training effort and
realigned our sales territories, however our estimated refill prescriptions were lower in the first
quarter of 2009 as compared to the fourth quarter of 2008.
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. Our specialty
distributor ships Acthar to specialty pharmacies and hospitals to meet end user demand. We track
our own Acthar shipments daily, but those shipments vary compared to end user demand because of
seasonal usage and changes in inventory levels at specialty pharmacies and hospitals. We estimate
that end user demand in the first quarter of 2009 exceeded our first quarter 2009 shipments by more
than 100 vials. We also review the amount of inventory of Acthar at CuraScript SD and Doral at
wholesalers 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.
Acthar shipments may be impacted by seasonality as well as quarter to quarter fluctuations
driven by the relatively small IS patient population. We believe these fluctuations are principally
due to the low incidence of IS, as a relatively small number of cases can create meaningful
fluctuations. We will continue to monitor these factors as there may be volatility in our Acthar
shipments and end user demand in future periods.
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 |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Cost of sales |
|
$ |
1,510 |
|
|
$ |
1,319 |
|
|
$ |
191 |
|
|
|
14 |
% |
Gross profit |
|
$ |
21,788 |
|
|
$ |
17,813 |
|
|
$ |
3,975 |
|
|
|
22 |
% |
Gross margin |
|
|
94 |
% |
|
|
93 |
% |
|
|
|
|
|
|
|
|
Cost of sales for the three month period ended March 31, 2009 increased $191,000 as compared
to the three month period ended March 31, 2008. Cost of sales includes material costs, 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 increases in product
stability testing and royalties on Acthar totaling approximately $490,000, offset in part by
decreases in distribution costs and direct materials. The gross margin was 94% for the three month
period ended March 31, 2009, as compared to 93% for the three month period ended March 31, 2008.
21
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
7,253 |
|
|
$ |
5,066 |
|
|
$ |
2,187 |
|
|
|
43 |
% |
The increase in selling, general and administrative expense for the three month period ended
March 31, 2009 as compared to the same period in 2008 was due primarily to increases in
headcount-related costs and costs associated with the support of our Acthar strategy, offset in
part by lower share-based compensation expense.
Headcount-related costs included in selling, general and administrative expense, excluding
share-based compensation, increased by approximately $1.2 million as compared to the same period in
2008. In January 2009 we announced that we were increasing our sales force to 30 representatives
in order to build upon continued positive growth trends in prescriptions of Acthar for the
treatment of exacerbations associated with MS, an indication for which Acthar is already approved.
During the first quarter of 2009 we completed the expansion of our sales force and added additional
managers. Depending upon the success of this first phase of our sales force expansion, a second
phase of our sales force expansion to approximately 40 representatives could occur later in 2009.
Costs associated with the support of our Acthar strategy increased by approximately $1.3
million in the three month period ended March 31, 2009 as compared to the same period in 2008. The
increase is due primarily to our marketing program for MS and costs related to the training of our
MS sales force.
We incurred a total non-cash charge of $1.0 million for SFAS No. 123(R) share-based
compensation related to employees and non-employee members of our board of directors for the
quarter ended March 31, 2009, as compared to $1.9 million for the quarter ended March 31, 2008. Of
this amount, $867,000 was included in selling, general and administrative expenses, a decrease of
$777,000 as compared to the same period in 2008. The decrease in share-based compensation expense
in the first quarter of 2009 was due primarily to an approximate $1.2 million decrease in expense
associated with our employee stock purchase plan as compared to the first quarter of 2008.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
2,456 |
|
|
$ |
1,971 |
|
|
$ |
485 |
|
|
|
25 |
% |
Costs included in research and development relate primarily to costs related to the
resubmission of our Acthar sNDA for IS to the FDA, the funding of medical research projects,
product development efforts and compliance activities. The increase in research and development
expenses was due primarily to an increase in costs related to our resubmission of our sNDA for IS
and increased funding of medical research projects to better understand the therapeutic benefit of
Acthar in current and new therapeutic applications. Expenses related to the resubmission of our
sNDA, which we submitted in March 2009, and medical research projects increased approximately
$500,000 in the three month period ended March 31, 2009 as compared to the same period in 2008.
These increases were partially offset by an approximate $200,000 decrease in product development
expenses. We are seeking a partner to complete development of QSC-001 so that our research and
development resources can be focused on pursuing potential growth opportunities for Acthar that
have recently been identified.
A non-cash charge of $151,000 for SFAS No. 123(R) share-based compensation was included in
research and development expenses in the three month period ended March 31, 2009, a decrease of
$82,000 as compared to the same period in 2008.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
118 |
|
|
$ |
122 |
|
|
$ |
(4 |
) |
|
|
(3 |
)% |
Depreciation and amortization expense for the three month period ended March 31, 2009 was
consistent with depreciation and amortization expense for the same period in 2008.
22
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
293 |
|
|
$ |
375 |
|
|
$ |
(82 |
) |
|
|
(22 |
)% |
Other income, net for the three month period ended March 31, 2009 decreased $82,000 as
compared to other income, net for the same period in 2008. The decrease was due primarily to lower
interest income resulting from a lower yield on our cash, cash equivalent and short-term investment
balances during the three month period ended March 31, 2009 as compared to the same period in 2008.
Income Before Income Taxes and Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Income before income taxes |
|
$ |
12,254 |
|
|
$ |
11,029 |
|
|
$ |
1,225 |
|
|
|
11 |
% |
Income tax expense |
|
$ |
4,580 |
|
|
$ |
4,488 |
|
|
$ |
92 |
|
|
|
2 |
% |
Income before income taxes for the three month period ended March 31, 2009 was $12.3 million
as compared to $11.0 million for the three month period ended March 31, 2008. 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 March 31, 2009 was $4.6 million as compared to $4.5 million for the
three month period ended March 31, 2008. During the quarter ended March 31, 2009, our effective
tax rate for financial reporting purposes was approximately 37.4% as compared to approximately 41%
for the quarter ended March 31, 2008. The decrease in our effective income tax rate results
primarily from lower nondeductible share-based compensation expense and lower state income taxes in
2009.
Net Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income |
|
$ |
7,674 |
|
|
$ |
6,541 |
|
|
$ |
1,133 |
|
|
|
17 |
% |
For the three month period ended March 31, 2009, we had net income of $7.7 million as compared
to net income of $6.5 million for the three month period ended March 31, 2008, an increase of $1.1
million. The increase resulted primarily from the increase in net sales and the changes in expenses
discussed above, and a lower effective tax rate for financial reporting purposes in the three month
period ended March 31, 2009 as compared to the same period in 2008.
Series A Preferred Stock Dividend
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Deemed dividend on Series A Preferred Stock |
|
$ |
|
|
|
$ |
5,267 |
|
|
$ |
(5,267 |
) |
|
|
(100 |
)% |
The deemed dividend resulted from the repurchase of our Series A Preferred Stock in February
2008. We repurchased all of the outstanding Series A Preferred Stock in February 2008 for cash
consideration of $10.3 million or $4.80 per share. As of December 31, 2007, the Series A Preferred
Stock had a carrying amount of $5.1 million. 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.
23
Net Income Applicable to Common Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
% |
|
|
2009 |
|
2008 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income applicable to common shareholders |
|
$ |
7,674 |
|
|
$ |
1,274 |
|
|
$ |
6,400 |
|
|
|
502 |
% |
For the three month period ended March 31, 2009, we had net income applicable to common
shareholders of $7.7 million, or $0.11 per fully diluted share, as compared to net income
applicable to common shareholders of $1.3 million, or $0.02 per fully diluted share, for the three
month period ended March 31, 2008, an increase of $6.4 million. In the first quarter of 2008, the
deemed dividend on Series A Preferred Stock reduced net income by $5.3 million, and reduced fully
diluted earnings per share applicable to common shareholders by $0.07.
Liquidity and Capital Resources
Prior to the implementation of our strategy and business model for Acthar in August 2007, we
principally funded our activities through various issuances of equity securities and debt and from
the sale of our non-core commercial product lines. During the three month period ended March 31,
2009, we generated $12.1 million in cash from operations. The $12.1 million in cash flow generated
from operations included a $3.0 million reduction of prepaid income taxes resulting principally
from the application of prepaid income taxes against our first quarter of 2009 estimated tax
liability.
At March 31, 2009, we had cash, cash equivalents and short-term investments of $61.1 million
compared to $55.5 million at December 31, 2008. The increase was due primarily to $12.1 million of
cash generated from operations and $250,000 in proceeds from the issuance of common stock under our
employee stock purchase plan and from the exercise of stock options, partially offset by $6.8
million paid to repurchase our common stock. At March 31, 2009, our working capital was $61.4
million compared to $59.3 million at December 31, 2008. The increase in our working capital was
principally due to the $5.6 million increase in cash, cash equivalents and short-term investments
and a decrease of $1.5 million in accrued compensation and other accrued liabilities, partially
offset by a decrease in prepaid income taxes of $3.0 million and a decrease in accounts receivable
of $1.6 million.
In February 2008 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. During the
quarter ended March 31, 2009, we repurchased 1,344,900 shares of our common stock at an average price
of $5.04 per share, for a total purchase price of $6.8 million. From April 1, 2009 through May 7,
2009, we repurchased an additional 210,000 shares of our common stock
at an average price of $4.44 per
share, for a total purchase price of $933,000. Through May 7, 2009, we have repurchased a total
of 5,045,800 shares of our common stock for $23.3 million under our stock repurchase plan, at an average
price of $4.61 per share. As of May 7, 2009, there are
1,954,200 shares remaining under the stock
repurchase plan.
24
We lease a 30,000 square foot facility in Hayward, California. Our master lease on the Hayward
facility expires in November 2012. As of March 31, 2009, we were obligated to pay rent on the
Hayward facility of $3.2 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. In May
2009, we entered into a three-month extension of the sublease of the 5,000 square foot portion of
the facility. 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.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at March 31, 2009 has not changed materially from December 31,
2008, 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, 2008.
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 Acthar-centric business
strategy, including its expansion in the MS marketplace; |
|
|
|
|
the Companys ability to manage its sales force expansion; |
25
|
|
|
FDA approval of and the market introduction of competitive products and the Companys
inability to market Acthar in IS prior to approval of IS as a labeled indication; |
|
|
|
|
the Companys ability to operate within an industry that is highly regulated at both the
Federal and state level; |
|
|
|
|
regulatory changes or actions including Federal or State health care reform initiatives; |
|
|
|
|
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; |
|
|
|
|
that the actual amount of rebates and chargebacks 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 attract and 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
and its preliminary work in the area of nephrotic syndrome; |
|
|
|
|
uncertainties regarding the Companys intellectual property; |
|
|
|
|
the uncertainty of receiving required regulatory approvals in a timely way, or at all;
and |
|
|
|
|
uncertainties in the credit and capital markets and the impact a further deterioration of
these markets could have on the Companys investment portfolio. |
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, 2008.
26
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 |
January 1 January 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,509,100 |
|
February 1 February 28, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,509,100 |
|
March 1 March 31, 2009 |
|
|
1,344,900 |
|
|
$ |
5.04 |
|
|
|
1,344,900 |
|
|
|
2,164,200 |
|
|
Total |
|
|
1,344,900 |
|
|
$ |
5.04 |
|
|
|
1,344,900 |
|
|
|
|
|
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.
From April 1, 2009 through
May 7, 2009, the Company repurchased an additional 210,000 shares of its
common stock at an average price of $4.44 per
share, for a total purchase price of $933,000 under
its stock repurchase program. To date, the Company has repurchased a
total of 5,045,800 shares of its
common stock for $23.3 million under its stock 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. |
|
|
|
* |
|
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. |
27
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
QUESTCOR PHARMACEUTICALS, INC.
|
|
Date: May 11, 2009 |
By: |
/s/ Don M. Bailey
|
|
|
|
Don M. Bailey |
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
By: |
/s/ Gary Sawka
|
|
|
|
Gary Sawka |
|
|
|
Senior Vice President, Finance and
Chief Financial Officer |
|
28
Exhibit Index
|
|
|
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. |
|
|
|
* |
|
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. |
29
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: May 11, 2009 |
/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:
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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; |
|
|
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) |
|
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):
|
a) |
|
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) |
|
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: May 11, 2009 |
/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
May 11, 2009, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2009 (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 March 31, 2009 (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: May 11, 2009 |
/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
May 11, 2009, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2009 (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 March 31, 2009 (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: May 11, 2009 |
/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.