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 JUNE 30, 2007
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934. |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
(State or other jurisdiction
of incorporation or organization)
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33-0476164
(I.R.S. Employer
Identification No.) |
3260 Whipple Road
Union City, CA 94587-1217
(Address of Principal Executive Offices)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 400-0700
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter prior that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark whether Registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
At August 6, 2007 there were 69,207,147 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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June 30, |
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December 31, |
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2007 |
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2006 |
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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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$ |
3,931 |
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$ |
15,937 |
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Short-term investments |
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10,142 |
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2,488 |
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Total cash, cash equivalents and short-term investments |
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14,073 |
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18,425 |
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Accounts receivable, net of allowance for doubtful accounts
of $44 and $55 at June 30, 2007 and December 31, 2006,
respectively |
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|
1,215 |
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1,783 |
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Inventories, net |
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2,414 |
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|
2,965 |
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Prepaid expenses and other current assets |
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555 |
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|
811 |
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Total current assets |
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18,257 |
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23,984 |
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Property and equipment, net |
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618 |
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665 |
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Purchased technology, net |
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4,117 |
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3,965 |
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Goodwill |
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299 |
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299 |
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Deposits and other assets |
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733 |
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722 |
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Total assets |
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$ |
24,024 |
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$ |
29,635 |
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LIABILITIES, PREFERRED STOCK AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,371 |
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$ |
2,154 |
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Accrued compensation |
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829 |
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1,019 |
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Sales-related reserves |
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2,465 |
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2,784 |
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Other accrued liabilities |
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464 |
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521 |
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Total current liabilities |
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5,129 |
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6,478 |
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Lease termination and deferred rent liabilities |
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1,974 |
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1,961 |
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Other non-current liabilities |
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13 |
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18 |
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Preferred stock, no par value, 7,500,000 shares authorized;
2,155,715 Series A shares issued and outstanding at June 30,
2007 and December 31, 2006 (aggregate liquidation preference of
$10,000 at June 30, 2007 and December 31, 2006) |
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5,081 |
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5,081 |
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Shareholders equity: |
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Common stock, no par value, 105,000,000 shares authorized;
69,207,147 and 68,740,804 shares issued and outstanding at
June 30, 2007 and December 31, 2006, respectively |
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106,551 |
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105,352 |
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Accumulated deficit |
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(94,732 |
) |
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(89,256 |
) |
Accumulated other comprehensive gain |
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8 |
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1 |
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Total shareholders equity |
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11,827 |
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16,097 |
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Total liabilities, preferred stock and shareholders equity |
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$ |
24,024 |
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$ |
29,635 |
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See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Net product sales |
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$ |
4,144 |
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$ |
3,329 |
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$ |
7,845 |
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$ |
5,339 |
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Operating costs and expenses: |
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Cost of product sales (exclusive of amortization of
purchased technology) |
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914 |
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652 |
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1,764 |
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1,278 |
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Selling, general and administrative |
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4,747 |
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4,241 |
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10,297 |
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8,411 |
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Research and development |
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951 |
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708 |
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2,091 |
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1,088 |
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Depreciation and amortization |
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125 |
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78 |
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248 |
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124 |
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Total operating costs and expenses |
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6,737 |
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5,679 |
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14,400 |
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10,901 |
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Loss from operations |
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(2,593 |
) |
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(2,350 |
) |
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(6,555 |
) |
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(5,562 |
) |
Other income (expense): |
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Interest income |
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181 |
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151 |
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391 |
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332 |
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Other income (expense), net |
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247 |
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(16 |
) |
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240 |
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(22 |
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Gain on sale of product rights |
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448 |
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448 |
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Total other income |
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876 |
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135 |
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1,079 |
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|
310 |
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Net loss |
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$ |
(1,717 |
) |
|
$ |
(2,215 |
) |
|
$ |
(5,476 |
) |
|
$ |
(5,252 |
) |
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Net loss per share basic and diluted |
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$ |
(0.02 |
) |
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$ |
(0.04 |
) |
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$ |
(0.08 |
) |
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$ |
(0.10 |
) |
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Shares used in computing net loss per share basic and diluted |
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68,989 |
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56,067 |
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68,882 |
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55,319 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Six Months Ended |
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June 30, |
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2007 |
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2006 |
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OPERATING ACTIVITIES |
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Net loss |
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$ |
(5,476 |
) |
|
$ |
(5,252 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Share-based compensation expense |
|
|
792 |
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|
431 |
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Depreciation and amortization |
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|
248 |
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|
124 |
|
Loss on disposal of equipment |
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12 |
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Gain on sale of product rights |
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(448 |
) |
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Changes in operating assets and liabilities: |
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Accounts receivable |
|
|
568 |
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|
(1,065 |
) |
Inventories |
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|
551 |
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(279 |
) |
Prepaid expenses and other current assets |
|
|
256 |
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|
|
198 |
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Accounts payable |
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|
(783 |
) |
|
|
119 |
|
Accrued compensation |
|
|
(190 |
) |
|
|
15 |
|
Sales-related reserves |
|
|
(319 |
) |
|
|
260 |
|
Other accrued liabilities |
|
|
(57 |
) |
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|
(93 |
) |
Income taxes payable |
|
|
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|
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(200 |
) |
Other non-current liabilities |
|
|
8 |
|
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|
507 |
|
|
|
|
|
|
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Net cash flows used in operating activities |
|
|
(4,838 |
) |
|
|
(5,235 |
) |
|
|
|
|
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INVESTING ACTIVITIES |
|
|
|
|
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|
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|
Purchase of property and equipment |
|
|
(65 |
) |
|
|
(61 |
) |
Acquisition of purchased technology |
|
|
(300 |
) |
|
|
(2,628 |
) |
Purchase of short-term investments |
|
|
(14,897 |
) |
|
|
(5,643 |
) |
Maturities of short-term investments |
|
|
7,250 |
|
|
|
6,140 |
|
Net proceeds from sale of product rights |
|
|
448 |
|
|
|
|
|
Changes in deposits and other assets |
|
|
(11 |
) |
|
|
93 |
|
|
|
|
|
|
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Net cash flows used in investing activities |
|
|
(7,575 |
) |
|
|
(2,099 |
) |
|
|
|
|
|
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FINANCING ACTIVITIES |
|
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|
|
|
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Issuance of common stock, net |
|
|
407 |
|
|
|
458 |
|
Redemption of Series B preferred stock |
|
|
|
|
|
|
(7,841 |
) |
Repayment of capital lease obligation |
|
|
|
|
|
|
(4 |
) |
|
|
|
|
|
|
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Net cash flows provided by (used in) financing activities |
|
|
407 |
|
|
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(7,387 |
) |
|
|
|
|
|
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Decrease in cash and cash equivalents |
|
|
(12,006 |
) |
|
|
(14,721 |
) |
Cash and cash equivalents at beginning of period |
|
|
15,937 |
|
|
|
20,438 |
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|
|
|
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Cash and cash equivalents at end of period |
|
$ |
3,931 |
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$ |
5,717 |
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|
|
|
|
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|
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Questcor Pharmaceuticals, Inc. (the Company or Questcor) is a specialty pharmaceutical
company that focuses on therapeutics for the treatment of diseases and disorders of the central
nervous system (CNS). Questcor owns two commercial CNS products, H.P. Acthar Gel®
(Acthar) and Doral®. Acthar (repository corticotropin injection) is an injectable drug
that is approved for the treatment of certain CNS disorders with an inflammatory component,
including the treatment of flares associated with multiple sclerosis (MS), and is also used in
treating patients with infantile spasm, an epileptic syndrome. Doral is indicated for the treatment
of insomnia, characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or
early morning awakenings, which occurs frequently in patients with CNS diseases and disorders. The
Companys strategy is to focus on Acthar and to develop through corporate collaborations new
medications focused on its target markets that would generally require lower capital investment
when compared to traditional pre-clinical development programs.
In May 2007, the Company announced the departure of its Chief Executive Officer, and Don
Bailey, a member of the Companys Board of Directors, was appointed Interim President.
In May 2007, the Company reduced its field organization from 45 to 13 employees. The
reduction in the field organization was the Companys first step in the execution of the Companys
plan to focus on Acthar, achieve consistent progress with its development pipeline and improve its
operating cash flows. The Company expects this reduction to generate annual cash savings of
between $4.0 million and $5.0 million. See Note 13 for further discussion of the Companys
reduction in its field organization. Other actions the Company has
taken to reduce costs are expected to increase the annual cash
savings to between $5.0 million and $6.0 million.
The accompanying unaudited consolidated financial statements of the Company have been prepared
in accordance with United States 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 United States 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, 2006. The accompanying
consolidated balance sheet at December 31, 2006 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, 2007.
The consolidated financial statements include the accounts of the Company and its wholly owned
subsidiary. All significant intercompany accounts and transactions have been eliminated.
Based on the Companys internal forecasts and projections, the Company believes that its cash
resources at June 30, 2007 will be sufficient to fund its operations through at least June 30,
2008, unless a substantial portion of its existing cash is used to develop products for CNS
disorders or its revenues are significantly less than it expects. The Companys future funding
requirements will depend on many factors, including: the implementation of its business strategy;
the timing and extent of product sales; the acquisition and licensing of products, technologies or
compounds, if any; the Companys ability to manage growth; competing technological and market
developments; costs involved in filing, prosecuting, defending and enforcing patent and
intellectual property claims; the receipt of licensing or milestone fees from current or future
collaborative and license agreements, if established; the timing of regulatory approvals; any
expansion or acceleration of its development programs; and other factors. If the Companys cash
resources and its revenues are not sufficient to meet its obligations, or if the Company has
insufficient funds to focus on Acthar, develop additional products or expand its operations, the
Company will seek to raise additional capital through public or private equity financing or from
other sources. However, to date traditional asset based debt financing has not been available on
acceptable terms. Additionally, the Company may seek to raise additional capital whenever
conditions in the financial markets are favorable, even if the Company does not have an immediate
need for additional cash at that time. There can be no assurance that the Company will be able to
obtain additional funds on desirable terms or at all.
6
2. SHARE-BASED COMPENSATION
Effective January 1, 2006, the Company adopted the fair value recognition provisions of
Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based Payment
(SFAS No. 123(R)), using the modified-prospective transition method. Under that transition
method, share-based compensation cost related to employees and non-employee members of the
Companys board of directors includes the compensation cost related to share-based payments granted
to employees and non-employee members of the board of directors through, but not yet vested as of
December 31, 2005, based on the grant-date fair value estimated in accordance with the provisions
of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS No. 123), and compensation cost
for share-based payments granted to employees and non-employee members of the board of directors
subsequent to December 31, 2005, based on the grant-date fair value estimated in accordance with
the provisions of SFAS No. 123(R).
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):
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Three Months Ended |
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|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Cost of product sales |
|
$ |
1 |
|
|
$ |
7 |
|
|
$ |
2 |
|
|
$ |
10 |
|
Selling, general and administrative |
|
|
292 |
|
|
|
207 |
|
|
|
697 |
|
|
|
328 |
|
Research and development |
|
|
62 |
|
|
|
6 |
|
|
|
129 |
|
|
|
10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
355 |
|
|
$ |
220 |
|
|
$ |
828 |
|
|
$ |
348 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation cost related to stock options granted to employees and non-employee
members of the board of directors is recognized as expense, net of estimated pre-vesting
forfeitures, ratably over the vesting period of the award. The Company has estimated an annual
pre-vesting forfeiture rate of 12% for a typical stock award with a four year vesting term. The
pre-vesting forfeiture rate was estimated based on historical data. No tax benefit has been
recognized related to share-based compensation expense since the Company has incurred operating
losses. The Company has established a full valuation allowance to offset all potential tax benefits
associated with its deferred tax assets.
The fair value of stock options awarded to employees and non-employee members of the Companys
board of directors was estimated using the Black-Scholes option valuation model. Expected
volatility is based on the historical volatility of the Companys stock. The expected term for the
three and six month periods ended June 30, 2007 and 2006 was estimated using the simplified method
described in Staff Accounting Bulletin No. 107 issued by the Securities and Exchange Commission.
The expected term represents the estimated period of time that stock options granted are expected
to be outstanding. The risk-free interest rate is based on the U.S. Treasury yield curve. The
expected dividend yield is zero, as the Company does not anticipate paying dividends in the near
future.
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|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Expected volatility |
|
|
84 |
% |
|
|
94 |
% |
|
|
84-86 |
% |
|
|
94-98 |
% |
Weighted average volatility |
|
|
84 |
% |
|
|
94 |
% |
|
|
86 |
% |
|
|
98 |
% |
Expected term (in years) |
|
|
6.25 |
|
|
|
6.25 |
|
|
|
6.25 |
|
|
|
6.25 |
|
Risk-free interest rate |
|
|
4.9 |
% |
|
|
5.1 |
% |
|
|
4.6-4.9 |
% |
|
|
4.8-5.1 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of the stock options granted to employees and
non-employee members of the Companys board of directors was $0.49 and $1.39 during the three month
periods ended June 30, 2007 and 2006, respectively, and $0.98 and $0.88 during the six month
periods ended June 30, 2007 and 2006, respectively.
The Company utilized the Black-Scholes option valuation model in connection with determining
the fair value of each option element of the Companys Employee Stock Purchase Plan. Expected
volatility is based on historical volatility of the Companys common stock. The expected term
represents the life of the option element. The risk-free interest rate is based on the U.S.
Treasury yield. The expected dividend yield is zero, as the Company does not anticipate paying
dividends in the near future.
7
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|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Expected volatility |
|
|
70 |
% |
|
|
94 |
% |
|
|
65-70 |
% |
|
|
94-98 |
% |
Weighted average volatility |
|
|
70 |
% |
|
|
94 |
% |
|
|
67 |
% |
|
|
95 |
% |
Expected term (in years) |
|
|
0.71 |
|
|
|
0.25 |
|
|
|
0.53-0.71 |
|
|
|
0.25 |
|
Risk-free interest rate |
|
|
5.0 |
% |
|
|
5.1 |
% |
|
|
5.0 |
% |
|
|
4.6-5.1 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value of each option element under the Companys Employee Stock
Purchase Plan was $0.47 and $0.25 for the three month periods ended June 30, 2007 and 2006,
respectively, and $0.42 and $0.19 during the six month periods ended June 30, 2007 and 2006,
respectively.
3. REVENUE RECOGNITION
For
the three and six month periods ended June 30, 2007 and 2006, the Company sold its
products to wholesalers, who in turn sold the products to pharmacies and hospitals. The Company
does not require collateral from its customers. Revenues from product sales are recognized based
upon shipping terms, net of estimated reserves for government chargebacks, Medicaid rebates,
payment discounts and returns for credit. Revenue is recognized upon customer receipt of the
shipment, provided that title to the product transfers at the point of receipt by the customer. If
the title to the product transfers at the point of shipment, revenue is recognized upon shipment of
the product.
The Company issues credit memoranda for expired product returned within six months beyond the
expiration date. The credit memoranda is equal to the sales value of the product returned and the
estimated amount of such credit memoranda is recorded as a liability with a corresponding reduction
in gross product sales. This reserve is reduced as credit memoranda are issued, with an offset to
accounts receivable. Returns are subject to inspection prior to acceptance. The Company records
estimated sales reserves for expected credit memoranda based primarily upon historical return rates
by product, analysis of return merchandise authorizations and returns received. The Company also
considers sales patterns, current inventory on hand at wholesalers, changes in prescription demand,
and other factors such as shelf life. The Company records estimated sales reserves for Medicaid
rebates and government chargebacks by analyzing historical rebate and chargeback percentages,
allowable Medicaid prices, and other factors, as required. Significant judgment is inherent in the
selection of assumptions and in the interpretation of historical experience as well as the
identification of external and internal factors affecting the estimate of reserves for product
returns, Medicaid rebates and government chargebacks. The Company routinely assesses the historical
returns and other experience including customers compliance with its return goods policy and
adjusts its reserves as appropriate.
Reserves for government chargebacks, Medicaid rebates, and product returns for credit
memoranda were $2.5 million and $2.8 million at June 30, 2007 and December 31, 2006, respectively,
and are included in Sales-Related Reserves in the accompanying Consolidated Balance Sheets.
During July 2007, the Company began utilizing CuraScript, Inc. (CuraScript), a third party
specialty pharmacy, to store and distribute Acthar and to assist Acthar patients with
reimbursement. Effective August 1, 2007, the Company no longer sells Acthar to wholesalers. The
Company reduced its estimate of reserves for Acthar product returns as of June 30, 2007 by
$558,000, due to a decrease in Acthar inventories held by the Companys wholesaler customers as
part of the Companys transition to CuraScript during June and July of 2007. Net sales of Acthar
for the three and six month periods ended June 30, 2007 include an increase in net sales of
$558,000 resulting from this reduction of the Companys estimate of reserves for Acthar product
returns. See Note 15 for further discussion of this subsequent event.
4. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
The Company considers highly liquid investments with maturities from the date of purchase of
three months or less to be cash equivalents. The Company had cash, cash equivalents and short-term
investments of $14.1 million and $18.4 million at June 30, 2007 and December 31, 2006,
respectively. Cash equivalents are invested in money market funds and commercial paper. Short-term
8
investments are invested in corporate bonds and commercial paper and have an average
contractual maturity of approximately 6 months as of June 30, 2007. The fair value of the funds
approximated their cost.
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist
of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
2,186 |
|
|
$ |
2,120 |
|
Finished goods |
|
|
683 |
|
|
|
1,082 |
|
Less allowance for excess and obsolete inventories |
|
|
(455 |
) |
|
|
(237 |
) |
|
|
|
|
|
|
|
|
|
$ |
2,414 |
|
|
$ |
2,965 |
|
|
|
|
|
|
|
|
6. PURCHASED TECHNOLOGY
Purchased technology at June 30, 2007 consists of the Companys acquisition costs related to
the May 2006 acquisition of the Doral product rights and a payment made in January 2007 to
eliminate the Doral royalty obligation. In January 2007, the Company made a cash payment of
$300,000 to IVAX Research, Inc. 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 $269,000 as of June 30, 2007.
7. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
The Company leases a 30,000 square foot facility in Hayward, California that is not occupied.
The Company is currently seeking a tenant for this space. The Companys master lease on the Hayward
facility expires in November 2012. As of June 30, 2007, the Company is obligated to pay rent on the
Hayward facility of $4.6 million and its share of insurance, taxes and common area maintenance
through the expiration of its master lease. As of June 30, 2007 and December 31, 2006, the
estimated liability related to the Hayward facility totaled $1.7 million and is included in Lease
Termination and Deferred Rent Liabilities in the accompanying Consolidated Balance Sheets. The fair
value of the liability was determined using a credit-adjusted risk-free rate to discount the
estimated future net cash flows, consisting of the minimum lease payments under the master lease,
net of estimated sublease rental income that could reasonably be obtained from the property. The
Company is also required to recognize an on-going accretion expense representing the difference
between the undiscounted net cash flows and the discounted net cash flows over the remaining term
of the Hayward master lease using the interest method. The accretion amount represents an on-going
adjustment to the estimated liability. The Company reviews the assumptions used in determining the
estimated liability quarterly and revises its estimate of the liability to reflect changes in
circumstances. During the quarter ended June 30, 2007, the Company revised its estimate of the
liability and recorded an additional loss of $401,000. The on-going accretion expense and any
revisions to the liability are recorded in Selling, General and Administrative expense in the
accompanying Consolidated Statements of Operations. During the three and six month periods ended
June 30, 2007, the Company recognized expense of $461,000 and $623,000, respectively, related to
the Hayward facility. During the three and six month periods ended June 30, 2006, the Company
recognized expense of $270,000 and $316,000, respectively, related to the Hayward facility.
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 June 30,
2007 and December 31, 2006.
From time to time, the Company may become involved in claims and other legal matters arising
in the ordinary course of business. Management is not currently aware of any such matters that will
have a material adverse affect on the financial position, results of operations or cash flows of
the Company.
9
8. NET INCOME (LOSS) PER SHARE
Basic and diluted net income (loss) per share is based on net income (loss) for the relevant
period, divided by the weighted average number of common shares outstanding during the period.
Diluted net income per share would give effect to all potentially dilutive common shares
outstanding during the period such as options, warrants, convertible preferred stock, and
contingently issuable shares. Diluted net loss per share has not been presented separately for the
three and six month periods ended June 30, 2007 and 2006 as, due to the Companys net loss
position, it is anti-dilutive. If the Company had net income per share of $0.01 or greater for the
three month period ended June 30, 2007, then shares used in calculating diluted earnings per share
would have included, if dilutive, the effect of outstanding options to purchase 7,387,337 common
shares, nonvested restricted stock awards of 42,603 common shares, an estimated 40,000 common
shares to be issued under the Employee Stock Purchase Plan in the current purchase period,
2,155,715 convertible preferred shares, placement agent unit options for 127,676 common shares and
warrants to purchase 475,248 common shares.
9. INCOME TAXES
Effective January 1, 2007, the Company adopted Financial Accounting Standards Board (FASB)
Interpretation 48 (FIN 48), Accounting for Uncertainty in Income Taxes an interpretation of
FASB Statement No. 109. The interpretation contains a two-step approach to recognizing and
measuring uncertain tax positions accounted for in accordance with SFAS No. 109, Accounting for
Income Taxes. The first step is to evaluate the tax position for recognition by determining if the
weight of available evidence indicates that it is more likely than not that the position will be
sustained on audit, including resolution of related appeals or litigation processes, if any. The
second step is to measure the tax benefit as the largest amount which is more than 50% likely of
being realized upon ultimate settlement.
Upon adoption of FIN 48, the Company commenced a review of its tax positions taken in its tax
returns that remain subject to examination. Based upon this review, the Company does not believe
that it has any material unrecognized tax benefits or that there is a material impact on its
financial condition or results of operations as a result of implementing FIN 48. As of June 30,
2007, the Company was subject to examination in the U.S. federal and various state tax
jurisdictions for all years in which the Company reported net operating losses that are being
carried forward.
The Company has sustained losses since inception which has generally resulted in a zero
percent effective tax rate; hence the Company has not incurred any interest or penalties. The
Companys policy is to recognize interest and penalties accrued on any unrecognized tax benefits as
a component of tax expense. At December 31, 2006, the Company had a $40.3 million deferred tax
asset which was fully offset by a valuation allowance due to its history of losses.
In addition, the Company has net operating loss carryfowards (NOLs) that may be subject to
substantial annual limitations due to the ownership change limitations provided by the Internal
Revenue Code and similar state provisions. The Company is currently evaluating whether there are
any changes in ownership that would limit the future use of its NOLs. Until the Company has
determined whether such an ownership change has occurred, and until the amount of any limitation
becomes known, no amounts are being presented as an uncertain tax position in accordance with FIN
48. The Company believes that the amount subject to limitation may result in a reduction of NOLs
available for use in future years and the related fully reserved deferred tax asset. However, given
the Companys history of losses, the Company does not expect the result of this evaluation will
have a material impact on its consolidated financial statements.
10. RELATED PARTY TRANSACTION
The Company had an option and license agreement with Roberts Pharmaceutical Corporation, a
subsidiary of Shire Pharmaceuticals Ltd. (Shire), for the development of a product. Shire holds
all of the Companys Series A Preferred Stock. The option expired in July 2001. The Company
maintained an accrual of $248,000 for development expenses related to the agreement. The accrual
was reversed in June 2007 as the Company determined that the
amount would not be due to Shire under
the agreement. The $248,000 accrual reversal is included in Other Income in the accompanying
Consolidated Statements of Operations for the three and six month periods ended June 30, 2007.
10
11. COMPREHENSIVE LOSS
Comprehensive loss is comprised of net loss and the change in unrealized holding gains and
losses on available-for-sale securities.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
($000s) |
|
|
($000s) |
|
Net loss |
|
$ |
(1,717 |
) |
|
$ |
(2,215 |
) |
|
$ |
(5,476 |
) |
|
$ |
(5,252 |
) |
Change in unrealized gains on available-for-sale securities |
|
|
5 |
|
|
|
(1 |
) |
|
|
7 |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(1,712 |
) |
|
$ |
(2,216 |
) |
|
$ |
(5,469 |
) |
|
$ |
(5,253 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
12. SALE OF PRODUCT RIGHTS
In June 2007, the Company divested its non-core development stage product Emitasol (nasal
metoclopramide) which resulted in a gain and net proceeds of $448,000. Under the terms of the
agreement, the Company may receive a royalty on product sales of Emitasol as well as future
payments based on the achievement of certain clinical and commercial goals. The gain from this
sale is included in Gain on Sale of Product Rights in the accompanying Consolidated Statements of
Operations for the three and six month periods ended June 30, 2007.
13. REDUCTION IN FIELD ORGANIZATION
In May 2007, the Companys Board of Directors approved a reduction in the Companys field
organization from 45 to 13 employees. The reduction of the field organization was completed on May
25, 2007 and represented the first step in the execution of the Companys plan to focus on Acthar,
achieve consistent progress with its development pipeline, and improve its operating cash flows.
The Companys one-time expense was comprised of $285,000 for severance benefits and $166,000 for
other associated costs. The one-time expense is included in Selling, General, and Administrative
Expense in the accompanying Consolidated Statements of Operations for the three and six month
periods ended June 30, 2007. The Company expects this reduction to generate annual cash savings of
between $4.0 million and $5.0 million.
14. RECENTLY ISSUED ACCOUNTING STANDARDS
In June 2007, the FASB issued EITF Issue No. 07-03, Accounting for Non-Refundable Advance
Payments for Goods or Services to Be Used in Future Research and Development Activities (EITF
07-03). EITF 07-03 provides guidance on whether non-refundable advance payments for goods that
will be used or services that will be performed in future research and development activities
should be accounted for as research and development costs or deferred and capitalized until the
goods have been delivered or the related services have been rendered. EITF 07-03 is effective for
fiscal years beginning after December 15, 2007. The Company is currently evaluating what effect, if
any, the adoption of EITF 07-03 will have on the Companys consolidated results of operations and
financial position.
In February 2007, the FASB issued Statement No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities (SFAS No. 159). SFAS No. 159 permits the measurement of many
financial instruments and certain other items at fair value. Entities may choose to measure
eligible items at fair value at specified election dates, reporting unrealized gains and losses on
such items at each subsequent reporting period. The objective of SFAS No. 159 is to provide
entities with the opportunity to mitigate volatility in reported earnings caused by measuring
related assets and liabilities differently without having to apply complex hedge accounting
provisions. It is intended to expand the use of fair value measurement. SFAS No. 159 is effective
for fiscal years beginning after November 15, 2007. The Company is currently evaluating what
effect, if any, the adoption of SFAS No. 159 will have on the Companys consolidated results of
operations and financial position.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157).
SFAS No. 157 defines fair value, establishes a market-based framework or hierarchy for measuring
fair value, and expands disclosures about fair value measurements. SFAS No. 157 is applicable
whenever another accounting pronouncement requires or permits assets and liabilities to be measured
at fair value. SFAS No. 157 does not expand or require any new fair value measures. The provisions
of SFAS No. 157 are to be applied prospectively and are effective for financial statements issued
for fiscal years beginning after November 15, 2007. The Company is currently evaluating what
effect, if any, the adoption of SFAS No. 157 will have on the Companys consolidated results of
operations and financial position.
11
15. SUBSEQUENT EVENT
During July 2007, the Company began utilizing CuraScript, a third party specialty pharmacy, to
store and distribute Acthar and to assist Acthar patients with reimbursement. Effective August 1,
2007, the Company no longer sells Acthar to wholesalers. The Company sells Acthar to CuraScript at
a discount from the Companys list price. Product sales are recognized net of this discount upon
receipt of the product by CuraScript. The Company will supply replacement product to CuraScript on
product returned one month prior to expiration to three months post
expiration. See Note 3 for
further discussion.
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, including statements regarding the
period of time during which our existing capital resources and income from various sources will be
adequate to satisfy our capital requirements. 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, 2006, including Item 1 Business of Questcor, 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 are a specialty pharmaceutical company that focuses on therapeutics for the treatment of
diseases and disorders of the central nervous system (CNS). We currently own two commercial CNS
products, H.P. Acthar Gel (Acthar) and Doral. Acthar (repository corticotropin injection) is an
injectable drug that is approved for the treatment of certain CNS disorders with an inflammatory
component, including the treatment of flares associated with multiple sclerosis (MS), and is also
used in treating patients with infantile spasm, an epileptic syndrome. Doral is indicated for the
treatment of insomnia, characterized by difficulty in falling asleep, frequent nocturnal
awakenings, and/or early morning awakenings, which occurs frequently in patients with CNS diseases
and disorders. Our strategy is to focus on Acthar and to develop through corporate collaborations
new medications focused on our target markets that would generally require lower capital investment
when compared to traditional pre-clinical development programs.
In May 2007, we announced the departure of our Chief Executive Officer, and Don Bailey, a
member of our Board of Directors, was appointed Interim President.
In May 2007, we reduced our field organization from 45 to 13 employees. The reduction in the
field organization was the first step in the execution of our plan to focus on Acthar, achieve
consistent progress with our development pipeline and improve our operating cash flows. We expect
this reduction to generate annual cash savings of between $4.0 million and $5.0 million. See Note
13 of the accompanying Notes to Consolidated Financial Statements for further discussion of our
reduction in our field organization. Other actions we have taken to
reduce costs are expected to increase the annual cash
savings to between $5.0 million and $6.0 million.
We have incurred an accumulated deficit of $94.7 million at June 30, 2007. At June 30, 2007,
we had $14.1 million in cash, cash equivalents and short-term investments. Our results of
operations may vary significantly from quarter to quarter depending on, among other factors, demand
for our products by patients and consumers, inventory levels of our products at wholesalers and
CuraScript, timing of expiration of our products, future credit memoranda to be issued under our
credit memoranda return policy, the availability of finished goods from our sole-source
manufacturers, the timing of certain expenses and the establishment of strategic alliances and
collaborative arrangements.
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
United States 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 sales reserves, product returns, bad debts, inventories,
intangible assets and share-based compensation. We base our estimates on
12
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 and six month periods ended June 30, 2007 and 2006, we have estimated reserves
for product returns from wholesalers, hospitals and pharmacies; government chargebacks for goods
purchased by certain Federal government organizations including the Veterans Administration;
Medicaid rebates to all states for products purchased by patients covered by Medicaid; and cash
discounts for prompt payment. We estimate our reserves by utilizing historical information for our
existing products and data obtained from external sources.
Significant judgment is inherent in the selection of assumptions and the interpretation of
historical experience as well as the identification of external and internal factors affecting the
estimates of our reserves for product returns, government chargebacks, and Medicaid rebates. We
believe that the assumptions used to estimate these sales reserves are the most reasonably likely
assumptions considering known facts and circumstances. However, our product return activity,
government chargebacks received, and Medicaid rebates paid could differ significantly from our
estimates because our analysis of product shipments, prescription trends and the amount of product
in the distribution channel may not be accurate. If actual product returns, government chargebacks,
and Medicaid rebates are significantly different from our estimates, or if the wholesalers fail to
adhere to our expired product returns policy, such differences would be accounted for in the period
in which they become known. To date, actual amounts have been consistent with our estimates.
We establish a reserve for the sales value of expired product expected to be returned by
wholesalers and their customers with a corresponding reduction in gross product sales. The reserve
is reduced as credit memoranda are issued, with an offset to accounts receivable. In estimating the
return rate for expired product, 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 adjust our reserves as appropriate.
In estimating Medicaid rebates, we match the actual rebates to the quantity of product sold by
pharmacies to arrive at an actual rebate percentage. This historical percentage is used to estimate
a rebate percentage that is applied to the sales to which the rebates apply to arrive at the
estimated rebate reserve for the period. We also consider allowable prices by Medicaid. In
estimating government chargeback reserves, we analyze actual chargeback amounts and apply
historical chargeback rates to sales to which chargebacks apply. We routinely assess our experience
with Medicaid rebates and government chargebacks and adjust the reserves accordingly. For qualified
customers, 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.
Product return, Medicaid rebate, and government chargeback reserves were $2.5 million and $2.8
million at June 30, 2007 and December 31, 2006, respectively, and are included in Sales-Related
Reserves in the accompanying Consolidated Balance Sheets.
During July 2007, we began utilizing CuraScript, a third party specialty pharmacy, to store
and distribute Acthar and to assist Acthar patients with reimbursement. Effective August 1, 2007,
we no longer sell Acthar to wholesalers. We sell Acthar to CuraScript at a discount from our list
price. Product sales are recognized net of this discount upon receipt of the product by
CuraScript. We will supply replacement product to CuraScript on product returned one month prior
to expiration to three months post expiration. Net sales of Acthar for the three and six month
periods ended June 30, 2007 include an increase in net sales of $558,000 resulting from a reduction
of our estimate of reserves for Acthar product returns as of June 30, 2007. The reduction in the
estimate of Acthar product returns resulted from a decrease in Acthar inventories held by our
wholesaler customers as part of our transition to CuraScript during June and July. See Notes 3 and
15 of the accompanying Notes to Consolidated Financial Statements for further discussion.
13
Inventories
As of June 30, 2007, our net raw material and finished goods inventories totaled $2.4 million.
We maintain inventory reserves 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 is less
favorable than projected, additional inventory write-offs may be required in the future which would
increase our cost of product 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 monitor our product
shipments to customers and compare these shipments against prescription demand for our individual
products.
Intangible and Long-Lived Assets
As of June 30, 2007, our intangible and long-lived assets consisted of goodwill of $299,000
generated from a merger in 1999, net purchased technology of $4.1 million related to our
acquisition of Doral and $618,000 of net property and equipment. The determination of whether or
not our intangible and long-lived assets are impaired and the expected useful lives of purchased
technology involves significant judgment. Changes in strategy or market conditions could
significantly impact these judgments and require a write-down of our recorded asset balances and a
reduction in the expected useful life of our purchased technology. Such a write-down of our
recorded asset balances or reduction in the expected useful life of our purchased technology would
increase our operating expenses. In accordance with SFAS No. 142, Goodwill and Other Intangible
Assets, we review goodwill for impairment on an annual basis. Our fair value is compared to the
carrying value of our net assets, including goodwill. If the fair value is greater than the
carrying amount, then no impairment is indicated. In accordance with SFAS No. 144, Accounting for
the Impairment or Disposal of Long-Lived Assets, we review long-lived assets, consisting of
property and equipment and purchased technology, for impairment whenever events or circumstances
indicate that the carrying amount may not be fully recoverable. As of June 30, 2007, no impairment
had been indicated.
Share-Based Compensation Expense
Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No.
123(R), using the modified-prospective transition method. Under the fair value recognition
provisions of SFAS No. 123(R), share-based compensation cost is estimated at the grant date based
on the fair value of the award and is recognized as expense, net of estimated pre-vesting
forfeitures, ratably over the vesting period of the award. We selected the Black-Scholes option
pricing model as the most appropriate fair value method for our awards. Calculating share-based
compensation expense requires the input of highly subjective assumptions, including the expected
term of the share-based awards, stock price volatility, and pre-vesting forfeitures. We estimated
the expected term of stock options granted for the three and six month periods ended June 30, 2007
and 2006 based on the simplified method provided in Staff Accounting Bulletin No. 107. We estimated
the volatility of our common stock at the date of grant based on the historical volatility of our
common stock. The assumptions used in calculating the fair value of share-based awards represent
our best estimates, but these estimates involve inherent uncertainties and the application of
management judgment. As a result, if factors change and we use different assumptions, our
share-based compensation expense could be materially different in the future. In addition, we are
required to estimate the expected pre-vesting forfeiture rate and only recognize expense for those
shares expected to vest. We estimate the pre-vesting forfeiture rate based on historical
experience. If our actual forfeiture rate is materially different from our estimate, our
share-based compensation expense could be significantly different from what we have recorded in the
current period.
Our net loss for the three and six month periods ended June 30, 2007 includes $355,000 and
$828,000, respectively, of share-based compensation expense related to employees and non-employee
members of our board of directors. Our net loss for the three and six month periods ended June 30,
2006 includes $220,000 and $348,000, 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.
14
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 June 30, 2007 and
December 31, 2006, the estimated liability related to the Hayward facility totaled $1.7 million 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. Currently the facility is vacant and we are seeking a tenant for the space. 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.
During the quarter ended June 30, 2007, we revised our estimate of the liability and recorded an
additional loss of $401,000.
We are also required to recognize an on-going accretion expense representing the difference
between the undiscounted net cash flows and the discounted net cash flows over the remaining term
of the Hayward master lease using the interest method. The accretion amount represents an on-going
adjustment to the estimated liability. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the accompanying
Consolidated Statements of Operations. During the three and six month periods ended June 30, 2007,
we recognized expense of $461,000 and $623,000, respectively, related to the Hayward facility.
During the three and six month periods ended June 30, 2006, we recognized expense of $270,000 and
$316,000, respectively, related to the Hayward facility.
Results of Operations
Three months ended June 30, 2007 compared to the three months ended June 30, 2006:
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
% |
|
|
|
2007 |
|
|
2006 |
|
|
Increase |
|
|
Change |
|
|
|
|
|
|
|
(in $000s) |
|
|
|
|
|
Net product sales |
|
$ |
4,144 |
|
|
$ |
3,329 |
|
|
$ |
815 |
|
|
|
24 |
% |
Net product sales for the three month periods ended June 30, 2007 and 2006 were comprised of
net product sales of our neurology products Acthar and Doral. Net sales of Acthar for the three
month period ended June 30, 2007 totaled $3.9 million as compared to $3.2 million during the same
period in 2006. The increase was due primarily to an increase in Acthar net sales of $558,000
resulting from a reduction of our estimate of reserves for Acthar product returns as of June 30,
2007. The reduction in the estimate of Acthar product returns resulted from a decrease in Acthar
inventories held by our wholesaler customers as part of our transition from traditional wholesaler
distribution to specialty pharmacy distribution during June and July of 2007. In addition, an
approximate 47% increase in the average Acthar selling price was offset by an approximate 30%
decrease in unit sales as compared to the same period in 2006.
As described further in Note 15 of the accompanying Notes to Consolidated Financial
Statements, during July 2007, we began utilizing CuraScript, a third party specialty pharmacy, to
store and distribute Acthar and to assist Acthar patients with reimbursement. Effective August 1,
2007, we no longer sell Acthar to wholesalers. We sell Acthar to CuraScript at a discount from our
list price. Product sales are recognized net of this discount upon receipt of the product by
CuraScript. We will supply replacement product to CuraScript on product returned one month prior
to expiration to three months post expiration.
We review the amount of inventory of our products at the wholesale level and CuraScript in
order to help assess the demand for our products. We may choose to defer sales in situations where
we believe inventory levels are already adequate. We expect quarterly
15
fluctuations in net product sales due to changes in demand for our products, the timing of
shipments, changes in wholesaler inventory levels, expiration dates of product sold, and the impact
of our sales-related reserves.
Cost of Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Cost of product sales |
|
$ |
914 |
|
|
$ |
652 |
|
|
$ |
262 |
|
|
|
40 |
% |
Cost of product sales includes material cost, packaging, warehousing and distribution, product
liability insurance, royalties, quality control (which primarily includes product stability
testing), quality assurance and reserves for excess or obsolete inventory. The increase was due
primarily to an increase of $105,000 in distribution costs and an increase in inventory reserves in
the three month period ended June 30, 2007 as compared to the same period in 2006. Cost of product
sales as a percentage of total net product sales was 22% for the three month period ended June 30,
2007, as compared to 20% for the three month period ended June 30, 2006. The increase in cost of
product sales as a percentage of total net product sales in the three month period ended June 30,
2007 as compared to the same period in 2006 was due primarily to increased inventory reserves and
distribution costs as a percentage of total net product sales in the three month period ended June
30, 2007.
Two of our wholesaler customers charge us a distribution fee. During July 2007, we began
utilizing CuraScript, a third party specialty pharmacy, to store and distribute Acthar and to
assist Acthar patients with reimbursement. Effective August 1, 2007, we no longer sell Acthar to
wholesalers or incur a distribution fee from wholesalers related to Acthar. We sell Acthar to
CuraScript at a discount from our list price. As a result, we do not expect a material change in
our cost of product sales as a percentage of sales as a result of our change to CuraScript.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
4,747 |
|
|
$ |
4,241 |
|
|
$ |
506 |
|
|
|
12 |
% |
The increase in selling, general and administrative expense was due primarily to severance and
other costs associated with the reduction of our field organization
and the departure of our Chief Executive Officer,
and an increase in expense associated with our Hayward facility. In May 2007, we reduced our field
organization from 45 to 13 employees. The reduction was the first step in the execution of our plan
to focus on Acthar, achieve consistent progress with our development pipeline and improve our
operating cash flows. The reduction of the field organization was completed on May 25, 2007. We
incurred a one-time expense of $451,000 for severance benefits and other associated costs. We
expect this reduction to generate annual cash savings of between $4.0 million and $5.0 million. In
addition, we recorded $272,000 of severance and other associated costs related to the departure of
our Chief Executive Officer in May 2007. During the quarter ended June 30, 2007, we revised our
estimate of our Hayward lease liability and recorded an additional loss of $401,000. Total
expenses associated with our Hayward facility for the three month period ended June 30, 2007
increased by $191,000 as compared to the three month period ended June 30, 2006. The increase in
selling, general and administrative expense was partially offset by a decrease of approximately
$240,000 in certain payroll related expenses associated with the reduction of our field
organization.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
951 |
|
|
$ |
708 |
|
|
$ |
243 |
|
|
|
34 |
% |
Costs included in research and development relate primarily to our product development
efforts, medical and regulatory affairs compliance activities and our preliminary evaluation of
additional development opportunities. The increase was due primarily to the
16
addition of our clinical and development leadership team during the fourth quarter of 2006.
Headcount-related costs in the three month period ended June 30, 2007 increased by approximately
$228,000 as compared to the same period in 2006. In August 2006, the FDA accepted for review our
supplemental new drug application (sNDA) seeking approval for Acthar for the treatment of infantile
spasms. In May 2007 we received an action letter from the FDA indicating that our sNDA was not
approvable in its current form. We are preparing to request a meeting with the FDA to discuss the action
letter. No drug is currently approved in the United States for the treatment of infantile spasms.
In November 2006, we initiated a clinical development program under our investigational new drug
application with the FDA for QSC-001, a unique orally disintegrating tablet formulation of
hydrocodone bitartrate and acetaminophen for the treatment of moderate to moderately severe pain.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
125 |
|
|
$ |
78 |
|
|
$ |
47 |
|
|
|
60 |
% |
The increase in depreciation and amortization was due primarily to amortization expense
related to the Doral purchased technology. In May 2006 we purchased the rights in the United States
to Doral. Our total purchase price, including acquisition costs, allocated to the Doral product
rights was $4.1 million. In addition, in January 2007, we made a $300,000 payment to IVAX to
eliminate the Doral royalty obligation that was recorded to purchased technology. Purchased
technology is being amortized on a straight-line basis over fifteen years, the expected life of the
Doral product rights.
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
876 |
|
|
$ |
135 |
|
|
$ |
741 |
|
|
|
549 |
% |
The increase in other income, net was due primarily to the gain on sale of product rights
related to Emitasol. In June 2007, we divested our non-core development stage product Emitasol
(nasal metoclopramide) which resulted in net proceeds of $448,000. In addition, in June 2007 we
reversed an accrual of $248,000 related to an agreement with Roberts Pharmaceutical Corporation, a
subsidiary of Shire Pharmaceuticals Ltd. (Shire), a related party, as we determined that the
amount would not be due to Shire under the agreement.
Six months ended June 30, 2007 compared to the six months ended June 30, 2006:
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net product sales |
|
$ |
7,845 |
|
|
$ |
5,339 |
|
|
$ |
2,506 |
|
|
|
47 |
% |
The increase in net product sales was due primarily to a 38% increase in Acthar net product
sales as compared to the six month period ended June 30, 2006. Net sales of Acthar for the six
month period ended June 30, 2007 totaled $7.2 million as compared to $5.2 million during the same
period in 2006. Net sales of Acthar for the six month period ended June 30, 2007 include an
increase in net sales of $558,000 resulting from a reduction of our estimate of reserves for Acthar
product returns as of June 30, 2007. The reduction in the estimate of Acthar product returns
resulted from a decrease in Acthar inventories held by our wholesaler customers as part of our
transition to CuraScript during June and July of 2007. The increase in Acthar net product sales was
also due to an approximate 41% increase in the average Acthar selling price as compared to the same
period in 2006. An increase in net product sales of Doral of $519,000 also contributed to the
increase in net product sales in the six month period ended June 30, 2007 as compared to the same
period in 2006. The six months ended June 30, 2007 included a full six months of Doral net product
sales as
17
compared to less than two months of Doral net product sales in the same period in 2006. We
purchased the rights in the United States to Doral in May 2006.
Cost of Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Cost of product sales |
|
$ |
1,764 |
|
|
$ |
1,278 |
|
|
$ |
486 |
|
|
|
38 |
% |
The increase in cost of product sales was due primarily to an increase of $355,000 in direct
material costs in the six month period ended June 30, 2007 as compared to the same period in 2006.
The increase in direct material costs was due primarily to an increase in the per unit material
cost of Acthar and an increase in inventory reserves. Cost of product sales as a percentage of
total net product sales was 23% for the six month period ended June 30, 2007, which was consistent
with 24% for the six month period ended June 30, 2006.
Two of our wholesaler customers charge us a distribution fee. During July 2007, we began
utilizing CuraScript, a third party specialty pharmacy, to store and distribute Acthar and to
assist Acthar patients with reimbursement. Effective August 1, 2007, we no longer sell Acthar to
wholesalers or incur a distribution fee from wholesalers related to Acthar. We sell Acthar to
CuraScript at a discount from our list price. As a result, we do not expect a material change in
our cost of product sales as a percentage of sales as a result of our change to CuraScript.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
10,297 |
|
|
$ |
8,411 |
|
|
$ |
1,886 |
|
|
|
22 |
% |
The increase in selling, general and administrative expense was due primarily to severance and
other costs associated with the reduction of our field organization and the departure of our Chief
Executive Officer, increased employee share-based compensation expense and an increase in expense
associated with our Hayward facility. In May 2007, we reduced our field organization from 45 to 13
employees. We incurred a one-time expense of $451,000 for severance benefits and other associated
costs. We expect this reduction to generate annual cash savings of between $4.0 million and $5.0
million. In addition, we recorded $272,000 of severance and other associated costs related to the
departure of our Chief Executive Officer in May 2007. We incurred a total non-cash charge of
$828,000 for employee share-based compensation for the six month period ended June 30, 2007. Of
this amount, $697,000 was included in selling, general and administrative expenses, an increase of
$369,000 as compared to the same period in 2006. Expenses associated with our Hayward facility for
the six month period ended June 30, 2007 increased by approximately $307,000 as compared to the six
month period ended June 30, 2006. During the quarter ended June 30, 2007, we revised our estimate
of our Hayward lease liability and recorded an additional loss of $401,000.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
2,091 |
|
|
$ |
1,088 |
|
|
$ |
1,003 |
|
|
|
92 |
% |
The increase in research and development was due primarily to the addition of our clinical and
development leadership team during the fourth quarter of 2006 and an increase in expenses
associated with our product development efforts. Headcount-related costs increased by
approximately $472,000 and product development expenses increased by approximately $168,000 in the
six month period ended June 30, 2007 as compared to the same period in 2006.
18
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
248 |
|
|
$ |
124 |
|
|
$ |
124 |
|
|
|
100 |
% |
The increase in depreciation and amortization was due primarily to amortization expense
related to the Doral purchased technology. In May 2006 we purchased the rights in the United States
to Doral. Our total purchase price, including acquisition costs, allocated to the Doral product
rights was $4.1 million and in January 2007, we made a $300,000 payment to IVAX to eliminate the
Doral royalty obligation that was recorded to purchased technology.
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2007 |
|
2006 |
|
Increase |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
1,079 |
|
|
$ |
310 |
|
|
$ |
769 |
|
|
|
248 |
% |
The increase in other income, net was due primarily to the gain on sale of product rights
related to Emitasol. In June 2007, we divested our non-core development stage product Emitasol
(nasal metoclopramide) which resulted in net proceeds of $448,000. In addition, in June 2007 we
reversed an accrual of $248,000 related to an agreement with Roberts Pharmaceutical Corporation, a
subsidiary of Shire Pharmaceuticals Ltd. (Shire), a related party, as we determined that the
amount would not be due to Shire under the agreement.
Liquidity and Capital Resources
We have funded our activities to date principally through various issuances of equity
securities and debt and from the sale of our non-core commercial product lines in October 2005.
At June 30, 2007, we had cash, cash equivalents and short-term investments of $14.1 million
compared to $18.4 million at December 31, 2006. The decrease was due primarily to $4.8 million of
cash used to fund our operations and a $300,000 payment in January 2007 to eliminate the Doral
royalty obligation, partially offset by net proceeds of $448,000 from the divestment of Emitasol in
June 2007 and $407,000 in proceeds from the issuance of common stock. At June 30, 2007, our
working capital was $13.1 million compared to $17.5 million at December 31, 2006. The decrease in
our working capital was principally due to cash used to fund operations.
In June 2007, we divested our non-core development stage product Emitasol (nasal
metoclopramide) which resulted in net proceeds of $448,000. Under the terms of the agreement we may
receive a royalty on product sales of Emitasol as well as future payments based on the achievement
of certain clinical and commercial goals.
On May 25, 2007, we reduced our field organization from 45 to 13 employees. The reduction of
our field organization represented the first step in the execution of our plan to focus on Acthar,
achieve consistent progress with our development pipeline, and improve our operating cash flows.
We incurred a one-time expense of $451,000, comprised of $285,000 paid in the second quarter of
2007 for severance benefits, and $166,000 for other associated costs. We expect this reduction of
our field organization to generate annual cash savings of between $4.0 million and $5.0 million.
Other actions we have taken to reduce costs are expected to increase the annual cash savings to between $5.0 million and
$6.0 million.
During July 2007, we began utilizing CuraScript, a third party specialty pharmacy, to store
and distribute Acthar and to assist Acthar patients with reimbursement. Effective August 1, 2007,
we no longer sell Acthar to wholesalers. We sell Acthar to CuraScript at a discount from our list
price. Product sales are recognized net of this discount upon receipt of the product by
CuraScript. We will supply replacement product to CuraScript on product returned one month prior
to expiration to three months post expiration. Net sales of Acthar for the three and six month
periods ended June 30, 2007 include an increase in net sales of $558,000 resulting from a reduction
of our estimate of reserves for Acthar product returns as of June 30, 2007. The reduction in the
estimate of Acthar product
19
returns resulted from a decrease in Acthar inventories held by our wholesaler customers as
part of our transition to CuraScript during June and July. See Notes 3 and 15 of the accompanying
Notes to Consolidated Financial Statements for further discussion of this subsequent event.
We lease a 30,000 square foot facility in Hayward, California that is not occupied. We are
currently seeking a tenant for this space. Our master lease on the Hayward facility expires in
November 2012. As of June 30, 2007, we were obligated to pay rent on the Hayward facility of $4.6
million and our share of insurance, taxes and common area maintenance through the expiration of the
master lease.
On January 3, 2006, pursuant to our notice to our Series B stockholders in November 2005, we
made a total cash payment of $7.8 million to redeem our outstanding Series B Preferred Stock.
Based on our internal forecasts and projections, we believe that our cash resources at June
30, 2007 will be sufficient to fund our operations through at least June 30, 2008, unless a
substantial portion of our existing cash is used to focus on Acthar, develop products for CNS
disorders or our revenues are significantly less than we expect. Our future funding requirements
will depend on many factors, including: the implementation of our business strategy; the timing and
extent of product sales; the acquisition and licensing of products, technologies or compounds, if
any; our ability to manage growth; competing technological and market developments; costs involved
in filing, prosecuting, defending and enforcing patent and intellectual property claims; the
receipt of licensing or milestone fees from current or future collaborative and license agreements,
if established; the timing of regulatory approvals; any expansion or acceleration of our
development programs; and other factors. If our cash resources and our revenues are not sufficient
to meet our obligations, or if we have insufficient funds to focus on Acthar, develop additional
products or expand our operations, we will seek to raise additional capital through public or
private equity financing or from other sources. However, traditional asset based debt financing has
not been available on acceptable terms. Additionally, we may seek to raise additional capital
whenever conditions in the financial markets are favorable, even if we do not have an immediate
need for additional cash at that time. There can be no assurance that we will be able to obtain
additional funds on desirable terms or at all.
Recently Issued Accounting Standards
In June 2007, the Financial Accounting Standards Board (FASB) issued EITF Issue No. 07-03,
Accounting for Non-Refundable Advance Payments for Goods or Services to Be Used in Future Research
and Development Activities (EITF 07-03). EITF 07-03 provides guidance on whether non-refundable
advance payments for goods that will be used or services that will be performed in future research
and development activities should be accounted for as research and development costs or deferred
and capitalized until the goods have been delivered or the related services have been rendered.
EITF 07-03 is effective for fiscal years beginning after December 15, 2007. We are currently
evaluating what effect, if any, the adoption of EITF 07-03 will have on our consolidated results of
operations and financial position.
In February 2007, the FASB issued Statement No. 159, The Fair Value Option for Financial
Assets and Financial Liabilities (SFAS No. 159). SFAS No. 159 permits the measurement of many
financial instruments and certain other items at fair value. Entities may choose to measure
eligible items at fair value at specified election dates, reporting unrealized gains and losses on
such items at each subsequent reporting period. The objective of SFAS No. 159 is to provide
entities with the opportunity to mitigate volatility in reported earnings caused by measuring
related assets and liabilities differently without having to apply complex hedge accounting
provisions. It is intended to expand the use of fair value measurement. SFAS No. 159 is effective
for fiscal years beginning after November 15, 2007. We are currently evaluating what effect, if
any, the adoption of SFAS No. 159 will have on our consolidated results of operations and financial
position.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157).
SFAS No. 157 defines fair value, establishes a market-based framework or hierarchy for measuring
fair value, and expands disclosures about fair value measurements. SFAS No. 157 is applicable
whenever another accounting pronouncement requires or permits assets and liabilities to be measured
at fair value. SFAS No. 157 does not expand or require any new fair value measures. The provisions
of SFAS No. 157 are to be applied prospectively and are effective for financial statements issued
for fiscal years beginning after November 15, 2007. We are currently evaluating what effect, if
any, the adoption of SFAS No. 157 will have on our consolidated results of operations and financial
position.
20
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at June 30, 2007 has not changed materially from December 31,
2006, 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, 2006.
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 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, 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 disclosure controls and procedures were deemed 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
Information about material risks related to our business, financial condition and results of
operations for the three and six months ended June 30, 2007, does not materially differ from that
set out in Part I, Item 1A of the Companys Annual Report on Form 10-K for the year ended December
31, 2006, other than the following additional risk factor:
We may experience distribution problems as a result of the outsourcing of our distribution
functions to CuraScript.
During July 2007 we began utilizing CuraScript, a third party specialty pharmacy, to store and
distribute Acthar and to assist Acthar patients with reimbursement. Effective August 1, 2007, we
no longer sell Acthar to wholesalers. The outsourcing of these functions is complex, and we may
experience difficulties that could reduce, delay or stop shipments of Acthar. If we encounter such
distribution problems, Acthar could become unavailable and we could lose revenues, or the costs to
distribute Acthar could become higher than we anticipate.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable
21
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Company held its 2007 Annual Meeting of Shareholders on May 11, 2007. The following
matters received the votes at the 2007 Annual Meeting of Shareholders as set forth below:
1. Election of Directors to hold office until the 2008 Annual Meeting of Shareholders and
until their successors are duly elected and qualified.
|
|
|
|
|
|
|
|
|
|
|
Votes For |
|
Votes Withheld |
Albert Hansen |
|
|
55,614,489 |
|
|
|
3,190,616 |
|
Don M. Bailey |
|
|
55,678,118 |
|
|
|
3,126,987 |
|
Neal C. Bradsher |
|
|
55,660,024 |
|
|
|
3,145,081 |
|
James L. Fares |
|
|
55,648,439 |
|
|
|
3,156,666 |
|
Gregg Lapointe |
|
|
55,409,739 |
|
|
|
3,395,366 |
|
Virgil D. Thompson |
|
|
55,426,519 |
|
|
|
3,378,586 |
|
David Young |
|
|
55,368,768 |
|
|
|
3,436,337 |
|
2. Ratification of Odenberg Ullakko Muranishi & Co. LLP as the Companys independent
auditors for the fiscal year ending December 31, 2007.
|
|
|
For:
|
|
55,709,488 |
Against:
|
|
3,027,109
|
Abstain:
|
|
68,508 |
ITEM 5. OTHER INFORMATION
Not applicable
ITEM 6. EXHIBITS
|
|
|
Exhibit No |
|
Description |
31
|
|
Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32*
|
|
Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor 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. |
22
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: August 10, 2007 |
By: |
/s/ Gregg Lapointe
|
|
|
|
Gregg Lapointe |
|
|
|
Director |
|
|
|
|
|
|
By: |
/s/ George Stuart
|
|
|
|
George Stuart |
|
|
|
Senior Vice President, Finance and Chief Financial Officer |
|
|
23
Exhibit Index
|
|
|
Exhibit No |
|
Description |
31
|
|
Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32 *
|
|
Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor 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. |
24
exv31
EXHIBIT 31
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Gregg Lapointe, 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 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)) for
the registrant and have:
|
a) |
|
designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is
being prepared; |
|
|
b) |
|
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 |
|
|
c) |
|
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 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 |
|
|
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. |
|
|
|
|
|
|
|
|
Date: August 10, 2007 |
/s/ Gregg Lapointe
|
|
|
Gregg Lapointe |
|
|
Director |
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, George Stuart, 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. Gregg Lapointe 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)) for the registrant and have:
|
a) |
|
designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us
by others within those entities, particularly during the period in which this report is
being prepared; |
|
|
b) |
|
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 |
|
|
c) |
|
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. Gregg Lapointe 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 |
|
|
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. |
|
|
|
|
|
|
|
|
Date: August 10, 2007 |
/s/ George Stuart
|
|
|
George Stuart |
|
|
Chief Financial Officer |
|
exv32
EXHIBIT 32
CERTIFICATION
On
August 10, 2007, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for
the quarter ended June 30, 2007 (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 June 30, 2007 (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.
|
|
|
|
|
|
|
|
Dated: August 10, 2007 |
/s/ Gregg Lapointe
|
|
|
Gregg Lapointe |
|
|
Director |
|
|
|
|
|
|
/s/ George Stuart
|
|
|
George Stuart |
|
|
Chief Financial Officer |
|
|
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.