e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2006 |
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
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33-0476164 |
(State or other jurisdiction
of incorporation or organization)
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(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 R No £
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
£ Accelerated
filer £
Non-accelerated filer R
Indicate by check mark whether Registrant is a shell company (as defined in Rule 12b-2 of
the Act). Yes £ No R
At May 5, 2006 there were 56,565,135 shares of the Registrants common stock, no par
value per share, outstanding.
QUESTCOR PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
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March 31, |
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December 31, |
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2006 |
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2005 |
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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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$ |
8,679 |
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$ |
20,438 |
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Short-term investments |
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6,497 |
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6,139 |
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Accounts receivable, net of allowance for doubtful accounts of $68 and $84 at
March 31, 2006 and December 31, 2005, respectively |
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946 |
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725 |
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Inventories, net |
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1,697 |
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1,577 |
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Prepaid expenses and other current assets |
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895 |
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710 |
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Total current assets |
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18,714 |
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29,589 |
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Property and equipment, net |
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655 |
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655 |
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Goodwill |
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299 |
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299 |
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Deposits and other assets |
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737 |
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805 |
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Total assets |
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$ |
20,405 |
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$ |
31,348 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,428 |
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$ |
1,505 |
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Accrued compensation |
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565 |
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709 |
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Sales-related reserves |
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2,542 |
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2,581 |
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Other accrued liabilities |
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436 |
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632 |
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Income taxes payable |
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200 |
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Preferred stock, 7,125 Series B shares at redemption amount at December 31, 2005 |
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7,841 |
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Total current liabilities |
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4,971 |
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13,468 |
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Lease termination and deferred rent liability |
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1,494 |
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1,350 |
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Other non-current liabilities |
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25 |
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27 |
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Preferred stock, no par value, 7,500,000 shares authorized; 2,155,715 Series A
shares issued and outstanding at March 31, 2006 and December 31, 2005 (aggregate
liquidation preference of $10,000 at March 31, 2006 and December 31, 2005) |
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5,081 |
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5,081 |
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Shareholders equity: |
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Common stock, no par value, 105,000,000 shares authorized; 54,843,530 and
54,461,291 shares issued and outstanding at March 31, 2006 and December 31,
2005, respectively |
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91,020 |
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90,576 |
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Deferred compensation |
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(5 |
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Accumulated deficit |
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(82,184 |
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(79,147 |
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Accumulated other comprehensive loss |
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(2 |
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(2 |
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Total shareholders equity |
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8,834 |
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11,422 |
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Total liabilities and shareholders equity |
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$ |
20,405 |
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$ |
31,348 |
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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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March 31, |
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2006 |
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2005 |
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Revenues: |
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Net product sales |
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$ |
2,010 |
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$ |
4,498 |
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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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626 |
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748 |
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Selling, general and administrative |
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4,170 |
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2,618 |
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Research and development |
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380 |
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499 |
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Depreciation and amortization |
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46 |
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311 |
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Total operating costs and expenses |
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5,222 |
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4,176 |
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Income (loss) from operations |
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(3,212 |
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322 |
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Other income (expense): |
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Non-cash amortization of deemed discount on convertible debentures |
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(108 |
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Interest income |
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181 |
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35 |
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Interest expense |
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(139 |
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Rental income (expense), net |
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(6 |
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43 |
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Total other income (expense) |
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175 |
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(169 |
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Net income (loss) |
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(3,037 |
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153 |
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Non-cash deemed dividend related to beneficial conversion feature of Series B preferred stock |
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84 |
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Dividends on Series B preferred stock |
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168 |
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Net loss applicable to common shareholders |
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$ |
(3,037 |
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$ |
(99 |
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Net loss per share applicable to common shareholders basic and diluted |
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$ |
(0.06 |
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$ |
0.00 |
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Shares used in computing net loss per share applicable to common shareholders basic and diluted |
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54,562 |
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51,216 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Three Months Ended |
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March 31, |
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2006 |
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2005 |
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OPERATING ACTIVITIES |
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Net income (loss) |
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$ |
(3,037 |
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$ |
153 |
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Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: |
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Share-based compensation expense |
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146 |
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1 |
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Amortization of deemed discount on convertible debentures |
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108 |
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Depreciation and amortization |
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46 |
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311 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(221 |
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132 |
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Inventories |
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(120 |
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128 |
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Prepaid expenses and other current assets |
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(185 |
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(43 |
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Accounts payable |
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(77 |
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(238 |
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Income taxes payable |
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(200 |
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Accrued compensation |
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(144 |
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(18 |
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Sales-related reserves |
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(39 |
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674 |
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Other accrued liabilities |
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(196 |
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178 |
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Other non-current liabilities |
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144 |
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(23 |
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Net cash flows provided by (used in) operating activities |
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(3,883 |
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1,363 |
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INVESTING ACTIVITIES |
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Purchase of property and equipment |
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(46 |
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(14 |
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Purchase of short-term investments |
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(3,498 |
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Maturities of short-term investments |
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3,140 |
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Acquisition of purchased technology |
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(2,000 |
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Proceeds from sale of equipment |
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1 |
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Decrease in other assets |
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68 |
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85 |
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Net cash flows used in investing activities |
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(336 |
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(1,928 |
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FINANCING ACTIVITIES |
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Issuance of common stock, net |
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303 |
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35 |
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Redemption of Series B preferred stock |
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(7,841 |
) |
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Short-term borrowings |
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191 |
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Repayment of short-term and long-term debt and capital lease obligation |
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(2 |
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(159 |
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Net cash flows provided by (used in) financing activities |
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(7,540 |
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67 |
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Decrease in cash and cash equivalents |
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(11,759 |
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(498 |
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Cash and cash equivalents at beginning of period |
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20,438 |
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8,729 |
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Cash and cash equivalents at end of period |
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$ |
8,679 |
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$ |
8,231 |
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SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
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Cash paid for interest |
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$ |
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$ |
58 |
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NON-CASH INVESTING AND FINANCING ACTIVITIES: |
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Deemed dividend related to beneficial conversion feature of Series B preferred stock |
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$ |
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$ |
84 |
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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) is a specialty pharmaceutical company that focuses on
novel therapeutics for the treatment of diseases and disorders of the central nervous system
(CNS). During the quarter ended March 31, 2006, Questcor owned and promoted a single
commercial CNS product, H.P. Acthar
Gel®
(Acthar). Acthar 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. The Companys strategy
is to (i) acquire or license commercial products that it believes have sales growth potential,
are promotionally responsive to a focused and targeted sales and marketing effort, complement
the Companys therapeutic focus on neurology and can be acquired or licensed at a reasonable
valuation relative to the Companys cost of capital, (ii) develop through corporate
collaborations new medications focused on its target markets that would generally be in the
later stages of development and require lower capital investment when compared to traditional
pre-clinical development programs, and (iii) co-promote selected CNS commercial products of other pharmaceutical companies.
In
connection with the Companys strategy to focus its efforts on promoting Acthar and building
a CNS product portfolio, in October 2005 the Company sold its non-core pharmaceutical product
lines Nascobal®,
Ethamolin® and
Glofil®-125 which resulted
in net proceeds of $24.8 million.
This transaction provided the Company with capital to retire its remaining outstanding debt
of $2.1 million in October 2005, redeem its outstanding Series B Preferred Stock for $7.8
million in January 2006, fund its on-going operations, and help expand its CNS product portfolio.
As described further in Note 13, in May 2006, the Company purchased the rights
in the United States to Doral®, a commercial product indicated for the treatment of insomnia,
which occurs frequently in patients with CNS diseases and disorders. The Company is currently
evaluating a number of potential opportunities to acquire, license, develop, and co-promote
products for CNS disorders that will fit its capital structure and commercial infrastructure.
The
accompanying unaudited consolidated financial statements of the Company have been prepared
in accordance with accounting principles generally accepted in the United States 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
accounting principles generally accepted in the United States 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, 2005. The accompanying balance sheet at December
31, 2005 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, 2006. The consolidated
financial statements include the accounts of the Company and its wholly owned subsidiaries.
All significant intercompany accounts and transactions have been
eliminated. The Companys
results of operations and cash flows for the quarter ended March 31, 2005 include the net
product sales and direct operating costs and expenses of the divested product lines and
VSL#3®.
The Companys agreement to promote VSL#3 terminated in January 2005.
2. SHARE-BASED COMPENSATION
The Company has the following share-based compensation arrangements: an Employee Stock Option
Plan that provides for the grant of stock options to employees, members of the Companys board of
directors, and consultants; a Non-Employee Directors Equity Incentive Plan that provides for the
grant of equity incentives to non-employee members of the Companys board of directors; and an
Employee Stock Purchase Plan that allows employee participants to purchase the Companys common
stock at a discount from the fair value of the Companys common stock. These stock option plans are
more fully described below and in Note 12 of the Companys 2005 Annual Report on Form 10-K.
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 for the quarter ended March 31, 2006 includes the following: (a)
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
6
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 previously
presented in pro forma footnote disclosures, and (b) 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). Prior to January 1, 2006, the Company accounted for share-based payments to its employees
and non-employee members of its board of directors under the recognition and measurement provisions
of APB Opinion No. 25, Accounting for Stock Issued to Employees, and related guidance, as permitted
by SFAS No. 123, and amended by SFAS No. 148, Accounting for Stock-Based Compensation-Transition
and Disclosure (SFAS No. 148). The Company did not recognize any significant share-based employee
compensation costs in its statements of operations prior to January 1, 2006, as options granted to
employees and non-employee members of the board of directors generally had an exercise price equal
to the fair value of the underlying common stock on the date of grant. As required by SFAS No.
148, prior to the adoption of SFAS No. 123(R), the Company provided pro forma disclosures of net
income (loss) applicable to common shareholders and net income (loss) per share applicable to
common shareholders as if the fair-value-based method defined in SFAS No. 123 had been applied.
Pro forma results for the quarter ended March 31, 2005 are presented below. The Companys results
for prior periods have not been restated.
As a result of adopting SFAS No. 123(R) using the modified prospective method, the Companys
net loss applicable to common shareholders for the quarter ended March 31, 2006 includes $128,000
of share-based compensation expense, net of estimated forfeitures, related to employees and
non-employee members of the board of directors. The effect of recognizing this share-based
compensation expense for the quarter ended March 31, 2006 had no impact on the Companys basic and
diluted net loss per share applicable to common shareholders. Share-based compensation expense
related to employees and non-employee members of the board of directors has been included in the
Companys statement of operations for the three months ended March 31, 2006 as follows (in
thousands):
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Three Months |
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Ended |
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March 31, 2006 |
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Cost of product sales |
|
$ |
4 |
|
Selling, general and administrative |
|
|
120 |
|
Research and development |
|
|
4 |
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Total |
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$ |
128 |
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|
Net cash proceeds from the exercise of stock options were $228,000 for the three months ended
March 31, 2006. There were no stock options exercised during the three months ended March 31,
2005.
The following table presents the pro forma effect on net loss applicable to common
shareholders and net loss per share applicable to common shareholders for the three months ended
March 31, 2005 as if the Company had applied the fair value recognition provisions of SFAS No. 123
to options granted under its share-based compensation arrangements during the three months ended
March 31, 2005 (in thousands, except per share amounts):
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Three Months Ended |
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|
March 31, 2005 |
|
Net loss applicable to common shareholders, as reported |
|
$ |
(99 |
) |
Add: Share-based employee compensation expense included reported net loss applicable to
common shareholders |
|
|
1 |
|
Deduct: Share-based employee compensation expense determined under the fair value method |
|
|
(121 |
) |
|
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|
|
Net loss applicable to common shareholders, pro forma |
|
$ |
(219 |
) |
|
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|
|
Basic and diluted net loss per share applicable to common shareholders: |
|
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|
|
As reported |
|
$ |
0.00 |
|
Pro forma |
|
$ |
0.00 |
|
Stock Option Plans
7
The Companys Employee Stock Option Plan provides for the grant of incentive and non-qualified
stock options with various vesting periods, generally four years, to employees, members of the
Companys board of directors and consultants. The exercise price of incentive stock options must
equal at least the fair market value on the date of grant, and the exercise price of non-qualified
stock options may be no less than 85% of the fair market value on the date of grant. The maximum
term of options granted is ten years. The aggregate number of shares of common stock authorized for
issuance under the Employee Stock Option Plan is 13,500,000 shares. The Companys Non-Employee
Directors Equity Incentive Plan provides for the granting of 25,000 options to purchase common
stock upon appointment as a non-employee director and 15,000 options each January thereafter for
continuing service upon reappointment. Such option grants vest over four years. In addition, 10,000
options are granted to members of one or more committees of the board of directors and an
additional 7,500 options to chairmen of one or more committees. Such option grants are fully vested
at the time of grant. All option grants are made at an exercise price equal to the fair market
value of the Companys common stock on the date of grant. The maximum term of the options granted
is ten years. Under the terms of the Non-Employee Directors Equity Incentive Plan, 1,250,000
shares of the Companys common stock were authorized for grant.
The fair value of options awarded during the three months ended March 31, 2006 and 2005 was
estimated using the Black-Scholes option valuation model with the assumptions noted in the
following table. Expected volatility is based on the historical volatility of the Companys stock.
The expected term for the three months ended March 31, 2006 was estimated using the simplified
method described in Staff Accounting Bulletin No. 107 issued by the Securities and Exchange
Commission. The expected term for the three months ended March 31, 2005 was estimated using
factors that included historical exercise patterns and expected terms used by comparable companies.
The expected term represents the estimated period of time that options granted are expected to be
outstanding. The risk-free rate is based on the U.S. Treasury yield curve.
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Three Months Ended |
|
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
Expected volatility |
|
|
98 |
% |
|
|
69 |
% |
Expected term (in years) |
|
|
6.25 |
|
|
|
3.9 |
|
Risk-free rate |
|
|
4.8 |
% |
|
|
4.2 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
The SFAS No. 123(R) share-based compensation expense for the three months ended March 31, 2006
has been reduced by an estimated forfeiture rate of 26.5%, based on historical data. In the pro
forma information for periods prior to 2006, the Company accounted for forfeitures as they
occurred.
A summary of options under the Companys stock option plans as of December 31, 2005 and
changes during the quarter ended March 31, 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
Weighted- Average Exercise Price |
|
|
Weighted- Average Remaining Contractual Term (in years) |
|
|
Aggregate Intrinsic Value (in thousands) |
|
Options outstanding at December 31, 2005 |
|
|
6,402,074 |
|
|
$ |
0.76 |
|
|
|
7.84 |
|
|
|
|
|
Options granted |
|
|
1,569,500 |
|
|
|
1.05 |
|
|
|
|
|
|
|
|
|
Options exercised |
|
|
(247,807 |
) |
|
|
0.92 |
|
|
|
|
|
|
|
|
|
Options forfeited or expired |
|
|
(330,921 |
) |
|
|
1.33 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options outstanding at March 31, 2006 |
|
|
7,392,846 |
|
|
$ |
0.79 |
|
|
|
8.21 |
|
|
$ |
6,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options vested and exercisable at March 31, 2006 |
|
|
2,429,232 |
|
|
$ |
0.96 |
|
|
|
6.44 |
|
|
$ |
1,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggregate intrinsic value is the sum of the amounts by which the quoted market price of the
Companys stock exceeded the exercise price of the options at March 31, 2006, for those options for
which the quoted market price was in excess of the exercise price (in-the-money options). The
weighted-average grant-date fair value of the options granted was $0.78 and $0.25 during the three
8
months ended March 31, 2006 and 2005, respectively. The total intrinsic value of options
exercised was $82,000 for the three months ended March 31, 2006. There were no options exercised
during the three months ended March 31, 2005.
As of March 31, 2006, $1.6 million of total unrecognized compensation cost related to unvested
share-based compensation arrangements granted under the Companys stock option plans is expected to
be recognized over a weighted-average period of 2.7 years. No tax benefit will be 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 of the potential tax benefits
associated with its deferred tax assets.
Employee Stock Purchase Plan
The Employee Stock Purchase Plan provides for payroll deductions for eligible employees to
purchase the Companys common stock at the lesser of (i) 85% of the fair market value of the common
stock on the offering date and (ii) 85% of the fair market value of the common stock on the
purchase date. As of March 31, 2006, the Company had issued 1,356,828 shares over the life of the
Employee Stock Purchase Plan of which 134,432 shares were issued during the three months ended
March 31, 2006. As of March 31, 2006, the Company had 143,155 shares reserved for future issuance
under the Employee Stock Purchase Plan.
The fair value of each option element of the Companys Employee Stock Purchase Plan is
estimated using the Black-Scholes option valuation model with the assumptions noted in the
following table. Expected volatility is based on historical volatility of the Companys common
stock. The expected term represents the length of each purchase period. The risk-free rate is
based on the U.S. Treasury yield.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
Expected volatility |
|
|
98 |
% |
|
|
64 |
% |
Expected term (in years) |
|
|
0.25 |
|
|
|
0.24 |
|
Risk-free rate |
|
|
4.6 |
% |
|
|
3.7 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
Cash received from employee contributions to the Employee Stock Purchase Plan were $74,000 and
$35,000 for the three months ended March 31, 2006 and 2005, respectively. The weighted average
fair value of each option element of the Companys Employee Stock Purchase Plan was $0.14 and $0.23
for the three months ended March 31, 2006 and 2005, respectively.
3. REVENUE RECOGNITION
The Company sells its products to wholesalers, who in turn sell 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 Companys policy of issuing credit memoranda for expired product, which became effective
for product lots released after May 31, 2004, allows customers to return expired product for credit
within six months beyond the expiration date. Customers who return expired product from production
lots released after May 31, 2004 will be issued credit memoranda 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. The Companys product exchange policy, which
applies to product lots released prior to June 1, 2004, allows customers to return expired product
for exchange within six months beyond the expiration date. Returns from these product lots are
exchanged for replacement product, and estimated costs for such exchanges, which include actual
product material costs and related shipping charges, are included in Cost of Product Sales in the
accompanying Consolidated Statements of Operations. Returns are subject to inspection prior to
acceptance.
The Company records estimated sales reserves for expected credit memoranda and product
exchanges based upon historical return rates by product, analysis of return merchandise
authorizations, returns received, sales patterns, current inventory on hand at
9
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 return goods policy and adjusts its reserves as appropriate.
Reserves for government chargebacks, Medicaid rebates, product returns for credit memoranda
and product exchanges related to Acthar were $2.2 million and $2.1 million at March 31, 2006 and
December 31, 2005, respectively, and are included in Sales-Related Reserves in the accompanying
Consolidated Balance Sheets.
In connection with the sale of the Nascobal, Ethamolin and Glofil-125 product lines, the
Company is responsible for all Medicaid rebates and government chargebacks on its sales of these
products through October 17, 2005. The Company is also responsible for product returns on its sales
of Nascobal and Ethamolin through October 17, 2005, but only to the extent the returns were
authorized by January 31, 2006. Subsequent to October 17, 2005, the Company no longer has access to
Nascobal and Ethamolin to facilitate product replacements under the Companys product replacement
policy. As a result, credit is issued on all authorized returns of these products after October 17,
2005. The difference between the amount of credit to be issued on the divested products and the
amounts accrued in the Companys product replacement and credit memorandum reserves was considered
in the determination of the computed gain on the sale of the divested products. The Company had
total sales-related reserves related to these products of $342,000 and $478,000 at March 31, 2006
and December 31, 2005, respectively, that are included in Sales-Related Reserves in the
accompanying Consolidated Balance Sheets.
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 $15.2 million and $26.6 million at March 31, 2006 and December 31, 2005,
respectively. All cash equivalents are in money market funds and commercial paper. The fair value
of the funds approximated 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):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
1,256 |
|
|
$ |
1,335 |
|
Work in process |
|
|
320 |
|
|
|
|
|
Finished goods |
|
|
240 |
|
|
|
342 |
|
Less allowance for excess and obsolete inventories |
|
|
(119 |
) |
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,697 |
|
|
$ |
1,577 |
|
|
|
|
|
|
|
|
6. GOODWILL
The Company monitors the carrying value of the goodwill through annual impairment tests or
more frequently if indicators of potential impairment exist. As of March 31, 2006 and December 31,
2005, no impairment had been indicated.
7. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
The Company, as permitted under California law and in accordance with its Bylaws, indemnifies
its officers and directors for certain events or occurrences while the officer or director is or
was serving at the Companys request in such capacity. The potential future indemnification limit
is to the fullest extent permissible under California law; however, the Company has a director and
officer insurance policy that limits its exposure and may enable it to recover a portion of any
future amounts paid. The Company believes the fair value of these indemnification agreements is
minimal. Accordingly, the Company has no liabilities recorded for these agreements as of March 31,
2006 and December 31, 2005.
10
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.
8. NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
Basic and diluted net loss per share applicable to common shareholders is based on net loss
applicable to common shareholders for the relevant period, divided by the weighted average number
of common shares outstanding during the period. Diluted net income per share applicable to common
shareholders 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 applicable to common shareholders has not been presented separately for
the periods ended March 31, 2006 and 2005 as, due to the Companys net loss position, it is
anti-dilutive. If the Company had net income per share applicable to common shareholders of $0.01
or greater for the three month period ended March 31, 2006, then shares used in calculating diluted
earnings per share applicable to common shareholders would have included, if dilutive, the effect
of outstanding options to purchase 7,392,846 common shares, 2,155,715 convertible preferred shares,
placement agent unit options for 127,676 common shares and warrants to purchase 3,548,363 common
shares.
9. EQUITY TRANSACTIONS
In January 2006, pursuant to the Companys notice to its Series B stockholders in November
2005, the Company made a total cash payment of $7.8 million to redeem its outstanding Series B
Preferred Stock (See Note 10 Redemption of Series B Convertible Preferred Stock). In March
2006, warrants to purchase 859,494 shares of the Companys common stock at $1.70 per share expired
unexercised. In April and May 2006, 1,647,439 shares of the Companys common stock were issued
upon the cash-less net exercise of 2,889,925 warrants issued to certain Series B stockholders. As
of May 5, 2006, the Company had outstanding 56,565,135 shares of common stock, 2,155,715 shares of
Series A Convertible Preferred Stock, 613,938 warrants to purchase shares of the Companys common
stock, 7,367,181 options to purchase shares of the Companys common stock, and 127,676 placement
agent unit options to purchase shares of the Companys common stock.
10. REDEMPTION OF SERIES B CONVERTIBLE PREFERRED STOCK
On January 3, 2006, pursuant to the Companys notice to its Series B stockholders in November
2005, the Company made a total cash payment of $7.8 million to redeem its outstanding Series B
Preferred Stock. The Company issued the Series B Preferred Stock and warrants to purchase common
stock in a January 2003 private placement. Pursuant to the terms of the Series B Preferred Stock,
January 1, 2006 was the first date on which the Company could redeem the Series B Preferred Stock.
The Series B preferred stockholders had the option to convert all or part of their Series B
Preferred Stock into the Companys common stock prior to the redemption date. During the year ended
December 31, 2005 the Company issued 1,353,118 shares of its common stock to the Series B
stockholders upon conversion of 1,275 shares of Series B Preferred Stock. The Company adjusted the
carrying value of the 7,125 outstanding shares of Series B Preferred Stock to its redemption amount
of $7.8 million at December 31, 2005, and classified it as a current liability. The Company also
recorded a deemed dividend of $1.4 million in the fourth quarter of 2005 representing the primary
difference between the redemption amount and the carrying value of the Series B Preferred Stock.
The redemption and conversion of the Series B Preferred Stock eliminated the Series B
Preferred Stock from the Companys capital structure and with it the Series B cash dividend
obligation of 10% in each of 2006 and 2007 and 12% thereafter, the Series B liquidation preference
and the Series B restrictive covenants. The Series B stockholders retained warrants to purchase
3,025,921 shares of the Companys common stock at $0.94 per share that were acquired by the Series
B stockholders in connection with their purchase of the Series B Preferred Stock. In April and May
2006, 1,647,439 shares of the Companys common stock were issued upon the cash-less net exercise of
2,889,925 warrants issued to certain Series B stockholders.
In March 2005, the Company and all of the holders of the outstanding shares of Series B
Preferred Stock entered into a Series B Preferred Shareholder Agreement and Waiver. Pursuant to
such agreement (i) the holders waived certain rights to receive additional dividends through March
31, 2006, (ii) the holders, with respect to dividends payable on April 1, 2005, July 1, 2005,
October 1, 2005 and January 1, 2006, accepted as full and complete payment of all such dividend
payments the issuance by the Company to them in a private placement of 1,344,000 shares of the
Companys common stock having an aggregate value equal to the dividends otherwise payable on those
dates, with the shares of common stock so issued valued at fair market value based upon a ten-day
weighted average
11
trading price formula through March 29, 2005, and (iii) the expiration date of the warrants to
purchase shares of the Companys common stock held by the holders was extended for one year, until
January 15, 2008.
As a result of the extension of the warrant expiration date, the Company revalued the warrants
issued to the Series B Preferred Stockholders, resulting in an incremental value of $84,000 which
decreased the carrying value of the preferred stock. The warrants were valued using the
Black-Scholes method with the following assumptions: a risk free interest rate of 3.9%; an
expiration date of January 15, 2008; volatility of 59% and a dividend yield of 0%. In connection
with the revaluation, in March 2005 the Company recorded $84,000 related to the beneficial
conversion feature on the Series B Preferred Stock as an additional deemed dividend, which
increased the carrying value of the Series B Preferred Stock.
11. RELATED PARTY TRANSACTIONS
In December 2001, the Company entered into a promotion agreement with VSL Pharmaceuticals
Inc., and its successor, Sigma-Tau Pharmaceuticals, Inc. (Sigma-Tau Pharmaceuticals), a private
company owned in part by the major shareholders of Sigma-Tau Finanziaria SpA (Sigma-Tau). The
promotion agreement expired in January 2005, in accordance with its terms. Under these agreements,
the Company agreed to purchase VSL#3 from Sigma-Tau Pharmaceuticals at a stated price, and also
agreed to promote, sell, warehouse and distribute the VSL#3 product directly to customers at its
cost and expense, subject to certain expense reimbursements. There was no VSL#3 revenue for the
quarter ended March 31, 2006 and minimal VSL#3 revenue for the quarter ended March 31, 2005.
12. COMPREHENSIVE INCOME (LOSS)
Comprehensive income (loss) is comprised of net income (loss) and the change in unrealized
holding gains and losses on available-for-sale securities. For the three month periods ended March
31, 2006 and 2005, net income (loss) was the same as comprehensive income (loss).
13. SUBSEQUENT EVENTS
In April and May 2006, 1,647,439 shares of the Companys common stock were issued upon the
cash-less net exercise of 2,889,925 warrants issued to certain Series B stockholders.
In May 2006, the Company purchased the rights in the United States to Doral® (Quazepam) from
MedPointe Healthcare Inc (MedPointe) pursuant to an Assignment and Assumption Agreement
(Agreement). Doral is a commercial product indicated for the treatment of insomnia, which occurs
frequently in patients with CNS diseases and disorders. The Company made a $2.5 million cash
payment on the transaction closing date and will make a second cash payment of $1.5 million within
forty-five days of the Companys receipt of written notification from the U.S. Food and Drug
Administration (FDA) of the FDAs approval for an alternative source to manufacture and supply
the active ingredient Quazepam for Doral. In addition, under the terms of the Agreement, the
Company received all finished goods inventories of Doral existing at the closing date and assumed
an obligation to pay a royalty to IVAX Research, Inc. on net sales of Doral. MedPointe is
obligated for all product returns, Medicaid rebates, and chargebacks on sales of Doral prior to the
closing date. The Company entered into a separate supply agreement with Medpointe to supply Doral
for an initial term of three years. The supply agreement may be extended for an additional term of
three years upon the written consent of both parties prior to the end of the initial term. The
Company will promote Doral to neurologists with its existing sales organization. The purchase
price allocated to the Doral product rights will be recorded to purchased technology and amortized
on a straight-line basis over the expected life of the Doral product rights. Gross ex-factory
sales of Doral for the year ended December 31, 2005 totaled $1.1 million.
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, 2005, including Item 1 Business of Questcor, Risk
Factors, as well as factors discussed in any documents incorporated by reference herein or
therein. Whenever used
12
in this Quarterly Report, the terms Questcor, Company, we, our, ours, and us refer
to Questcor Pharmaceuticals, Inc. and its consolidated subsidiaries.
Overview
We are a specialty pharmaceutical company that focuses on novel therapeutics for the treatment
of diseases and disorders of the central nervous system (CNS). During the quarter ended March 31,
2006, we owned and promoted a single commercial CNS product, H.P. Acthar Gel®
(Acthar). Acthar 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.
We announced our CNS strategy in April 2005. As part of this strategy, we intend to pursue the
licensing and acquisition of additional CNS commercial products, the development of new products
that have the potential to address unmet medical needs in the CNS field, using both our own
intellectual property and intellectual property acquired or licensed from other companies, and
selected opportunities to co-promote CNS commercial products of other pharmaceutical companies.
In connection with our strategy to focus our efforts on promoting Acthar and building a CNS
product portfolio, in October 2005 we sold our non-core pharmaceutical product lines Nascobal,
Ethamolin and Glofil-125 to QOL Medical LLC resulting in net proceeds of $24.8 million and a
pre-tax gain of $9.6 million. Our results of operations and cash flows for the quarter ended March
31, 2005 include the net product sales and direct operating costs and expenses of the divested
product lines and VSL#3. In January 2005, our agreement to promote and sell VSL#3 expired in
accordance with its terms. As described further in Note 13 of the accompanying Notes to
Consolidated Financial Statements and in Liquidity and Capital Resources below, in May 2006, we
purchased the rights in the United States to Doral, a commercial product indicated for the
treatment of insomnia, which occurs frequently in patients with CNS diseases and disorders.
Our expenditures on research and development activities to date have not been material.
Expenses incurred for medical and regulatory affairs activities are classified as Research and
Development expenses in the accompanying Consolidated Statements of Operations. We expect our
research and development spending to increase in the future as we implement our CNS strategy.
We have incurred an accumulated deficit of $82.2 million at March 31, 2006. At March 31, 2006,
we had $15.2 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, the
results of our sales efforts, demand for our products by patients and consumers, inventory levels
of our products at wholesalers, 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, the acquisition of marketed products,
the establishment of strategic alliances and collaborative arrangements and the receipt of
milestone payments.
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
accounting principles generally accepted in the United States. 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 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.
Product Returns, Rebates and Sales Reserves
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.
13
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 credit memoranda or product exchange 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.
During 2004 we implemented a transition plan for expired product returns from a product
exchange policy to a credit memoranda policy for the return of expired product within six months
after the expiration date. Expired product returned from lots released after May 31, 2004 is
subject to a credit memoranda policy in which a credit memoranda is issued for the original
purchase price of the returned product with a corresponding reduction in gross product sales. A
reserve for the sales value of estimated returns on shipments of Acthar product lots released and
shipped after May 31, 2004 has been recorded as a liability in the amount of $1.8 million as of
March 31, 2006. This reserve reflects an estimate of future credit memoranda to be issued, applied
to the quantity of Acthar product shipped from lots subject to the credit memoranda policy. The
reserve is reduced as credit memoranda are issued, with an offset to accounts receivable.
Under our product exchange policy, we ship replacement product for expired product returned to
us within six months after expiration. The estimated costs for such potential exchanges, which
include actual product costs and related shipping charges, are included in cost of product sales. A
reserve for estimated returns on shipments of Acthar product lots released and shipped prior to
June 1, 2004 has been recorded as a liability in the amount of $10,000 as of March 31, 2006. This
reserve reflects an estimate of future Acthar replacements, applied to the quantity of product
shipped from lots subject to the product exchange policy. The reserve will be reduced as future
product replacements occur, with an offset to product inventories.
In estimating the return rate for expired product subject to credit memoranda and product
exchange, we analyze (i) historical returns and sales patterns, (ii) current inventory on hand at
wholesalers and the remaining shelf life of that inventory, and (iii) changes in demand measured by
prescriptions or other data as provided by an independent third party source and our internal
estimates. 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 exchange 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
estimated based upon the amount of trade accounts receivable subject to the cash discounts.
Total sales-related reserves related to Acthar were $2.2 million and $2.1 million at March 31,
2006 and December 31, 2005, respectively, and are included in Sales-Related Reserves in the
accompanying Consolidated Balance Sheets.
In connection with the sale of the Nascobal, Ethamolin and Glofil-125 product lines, we are
responsible for all Medicaid rebates and government chargebacks on our sales of these products
through October 17, 2005. We are responsible for product returns on our sales of these products
through October 17, 2005, but only to the extent the returns were authorized by January 31, 2006.
Subsequent to October 17, 2005, we no longer have access to Nascobal and Ethamolin product
inventories to facilitate product replacements under our product replacement policy. As a result,
credit is issued on all authorized returns of these products after October 17, 2005. The difference
between the amount of credit expected to be issued on the divested products and the amounts accrued
in our product replacement and credit memorandum reserves as of October 17, 2005 was considered in
the determination of the computed gain on the sale of the divested products. We had total
sales-related reserves related to these products of $342,000 and $478,000 as of March 31, 2006 and
December 31, 2005, respectively, that are included in Sales-Related Reserves in the accompanying
Consolidated Balance Sheets.
14
Inventories
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. We intend
to control inventory levels of our products purchased by our customers. Customer inventories may be
compared to both internal and external databases to determine adequate inventory levels. We may
monitor our product shipments to customers and compare these shipments against prescription demand.
Intangible Assets
As of March 31, 2006 and December 31, 2005, our intangible asset relates to $299,000 of
goodwill generated from a 1999 merger with RiboGene, Inc. 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. As of March 31, 2006
and December 31, 2005, no impairment had been indicated.
Share-Based Compensation Expense
As described in detail in Note 2, Share-Based Compensation, of the accompanying Notes to
Consolidated Financial Statements, effective January 1, 2006, we adopted the fair value recognition
provisions of SFAS No. 123R, using the modified-prospective transition method. Under the fair
value recognition provisions of SFAS 123R, 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
forfeitures, ratably over the vesting period of the award. 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 option forfeitures. We estimated the
expected life of options granted for the three months ended March 31, 2006 based on the simplified
method provided in Staff Accounting Bulletin No. 107. We estimate 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 stock-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
forfeiture rate and only recognize expense for those shares expected to vest. We estimate the
forfeiture rate based on historical experience. If our actual forfeiture rate is materially
different from our estimate, the stock-based compensation expense could be significantly different
from what we have recorded in the current period.
As a result of adopting SFAS No. 123(R) using the modified prospective method, our net loss
applicable to common shareholders for the quarter ended March 31, 2006 includes $128,000 of
share-based compensation expense related to employees and non-employee members of our board of
directors. As of March 31, 2006, $1.6 million of total unrecognized compensation cost related to
unvested share-based compensation arrangements granted under our stock option plans is expected to
be recognized over a weighted-average period of 2.7 years. Prior to the adoption of SFAS No.
123(R), we provided pro forma disclosures of net income (loss) applicable to common shareholders
and net income (loss) per share applicable to common shareholders as if the fair-value-based method
had been applied. Our results for the quarter ended March 31, 2005 have not been restated.
Results of Operations
Three months ended March 31, 2006 compared to the three months ended March 31, 2005:
Total Revenues
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Three Months Ended |
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|
March 31, |
|
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% |
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|
2006 |
|
|
2005 |
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|
(Decrease) |
|
|
Change |
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(in $000's) |
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Net product sales |
|
$ |
2,010 |
|
|
$ |
4,498 |
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|
$ |
(2,488 |
) |
|
|
(55 |
)% |
Total revenues for the quarter ended March 31, 2006, which consisted of Acthar net product
sales only, decreased $2.5 million, or 55%, from the quarter ended March 31, 2005. Total net
product sales for the first quarter of 2005 included the net product sales of Acthar, Nascobal,
Ethamolin, Glofil-125 and VSL#3. We sold our non-core product lines Nascobal, Ethamolin and
Glofil-125 in October 2005. In January 2005, our agreement to promote VSL#3 terminated. First
quarter 2005 net product sales included $1.7
15
million in net product sales of the divested products and VSL#3. First quarter of 2006 Acthar
net product sales of $2.0 million decreased $765,000, or 28%, as compared to net product sales in
the first quarter of 2005. The decrease in net product sales of Acthar was due primarily to a 32%
decrease in volume as compared to the same period in 2005, and higher reserves recorded as a
reduction to gross sales during the first quarter of 2006 for Medicaid rebates. This decrease was
partially offset by an 11% increase in the average selling price of
Acthar. The comparative decrease in volume resulted primarily from a temporary increase in
demand for Acthar that began in the fourth quarter of 2004 and did not continue beyond
February 2005.
We review the amount of inventory of our products at the wholesale level in order to help
assess the demand for our products. We may choose to defer sales in situations where we believe
inventory levels are already adequate. We expect quarterly fluctuations in net product sales due to
changes in demand for our products, the timing of shipments, changes in wholesaler inventory
levels, expiration dates of product sold, the timing of replacement units shipped under our product
exchange policy, and the impact of our sales-related reserves.
As described further in Note 13 of the accompanying Notes to Consolidated Financial Statements
and in Liquidity and Capital Resources below, in May 2006, we purchased the rights in the United
States to Doral, a commercial product indicated for the treatment of insomnia, which occurs
frequently in patients with CNS diseases and disorders. We will promote Doral to neurologists with
our existing sales organization. Gross ex-factory sales of Doral for the year ended December 31,
2005 totaled $1.1 million. MedPointe is obligated for all product returns, Medicaid rebates, and
chargebacks on sales of Doral prior to the closing date.
Cost of Product Sales
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Three Months Ended |
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March 31, |
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% |
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2006 |
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2005 |
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(Decrease) |
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Change |
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(in $000s) |
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Cost of product sales |
|
$ |
626 |
|
|
$ |
748 |
|
|
$ |
(122 |
) |
|
|
(16 |
)% |
Cost
of product sales for the quarter ended March 31, 2006 decreased $122,000, or 16%, to $626,000
from $748,000 for the quarter ended March 31, 2005. 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 write-offs
of excess or obsolete inventory. The decrease in cost of product sales is due primarily to the
inclusion in the first quarter of 2005 of material, shipping and other costs of $283,000 related
to our non-core product lines which we sold in October 2005 and $48,000 related to VSL#3. The
VSL#3 promotion agreement with Sigma-Tau Pharmaceuticals, Inc. terminated in January 2005. The
decrease in material and other costs was partially offset by a $231,000 increase in stability
testing of Acthar in the first quarter of 2006 as compared to the same period in 2005. The
increase in stability testing was due to an increase in the number of stability tests on samples
of manufactured Acthar batches in the quarter ended March 31, 2006 as compared to the quarter
ended March 31, 2005. Cost of product sales as a percentage of total net product sales was
31.1% for the quarter ended March 31, 2006, as compared to 16.6% for the quarter ended March
31, 2005. The increase in cost of product sales as a percentage of total net product sales
in the first quarter of 2006 as compared to the same period in 2005 was due primarily to an
increase in Acthar stability testing costs as a percentage of total net product sales during
the quarter ended March 31, 2006.
As described further in Note 13 of the accompanying Notes to Consolidated Financial Statements
and in Liquidity and Capital Resources below, in May 2006, we purchased the rights in the United
States to Doral, a commercial product indicated for the treatment of insomnia, which occurs
frequently in patients with CNS diseases and disorders. We entered into a separate supply
agreement with Medpointe to supply Doral for an initial term of three years. The supply agreement
may be extended for an additional term of three years upon the written consent of both parties
prior to the end of the initial term.
Selling, General and Administrative
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Three Months Ended |
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March 31, |
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|
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% |
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|
2006 |
|
|
2005 |
|
|
Increase |
|
|
Change |
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|
|
(in $000s) |
|
Selling, general and administrative expense |
|
$ |
4,170 |
|
|
$ |
2,618 |
|
|
$ |
1,552 |
|
|
|
59 |
% |
Selling, general and administrative expenses for the quarter ended March 31, 2006 increased
$1.5 million from the quarter ended March 31, 2005, due primarily to the expansion of our sales
organization. During the fourth quarter of 2005 and the first quarter of 2006, we expanded our
sales organization to 40 field-based sales representatives and sales management as compared to 19
sales representatives and sales managers employed as of March 31, 2005. The expanded sales
organization was trained and fully deployed as of March 31, 2006. As a result of our sales
organization expansion and increased promotion of Acthar, our selling and marketing
16
expenses increased substantially in the first quarter of 2006. Sales and marketing
headcount-related costs increased by approximately $350,000 and marketing and promotional expenses
increased by approximately $310,000 in the quarter ended March 31, 2006 as compared to the same
period in 2005. Higher professional fees and increased headcount-related costs associated with
other personnel changes also contributed to the higher selling, general and administrative expenses
in the first quarter of 2006.
As described further in Note 2, Share-Based Compensation, of the accompanying Notes to
Consolidated Financial Statements and above in Critical Accounting Policies, effective January 1,
2006, we adopted SFAS No. 123R. We incurred a non-cash charge of $128,000 for the quarter ended
March 31, 2006 resulting from the adoption of SFAS No. 123R of which $120,000 was included in
selling, general and administrative expenses.
As described further in Note 13 of the accompanying Notes to Consolidated Financial Statements
and in Liquidity and Capital Resources below, in May 2006, we purchased the rights in the United
States to Doral, a commercial product indicated for the treatment of insomnia, which occurs
frequently in patients with CNS diseases and disorders. We will promote Doral to neurologists with
our existing sales organization.
Research and Development
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Three Months Ended |
|
|
|
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|
|
|
|
|
March 31, |
|
|
|
|
|
|
% |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
|
Change |
|
|
|
(in $000's) |
|
Research and development |
|
$ |
380 |
|
|
$ |
499 |
|
|
$ |
(119 |
) |
|
|
(24 |
)% |
Research and development expenses for the quarter ended March 31, 2006 were $380,000, a
decrease of $119,000 as compared to $499,000 for the quarter ended March 31, 2005. The costs
included in research and development relate primarily to our medical and regulatory affairs
compliance activities and development activities. A decrease in regulatory fees of approximately
$140,000 resulting from the sale of our non-core product lines in the fourth quarter of 2005 and a
decrease in patent-related legal fees contributed to the lower research and development expenses in
the first quarter of 2006 as compared to the first quarter of 2005. This decrease was partially
offset by an increase in fees for consulting and other outside services in the quarter ended March
31, 2006 as compared to the same period in 2005.
Depreciation and Amortization
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Three Months Ended |
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March 31, |
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|
% |
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|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
|
Change |
|
|
|
(in $000's) |
|
Depreciation and amortization |
|
$ |
46 |
|
|
$ |
311 |
|
|
$ |
(265 |
) |
|
|
(85 |
)% |
Depreciation and amortization expense for the quarter ended March 31, 2006 decreased to
$46,000 from $311,000 for the quarter ended March 31, 2005. The decrease was due primarily to the
inclusion in the first quarter of 2005 of amortization expense related to Nascobal purchased
technology. In connection with the sale of the Nascobal product line in October 2005, we included
the carrying value of the Nascobal purchased technology totaling $14.0 million in calculating the
gain on the sale of product lines. Accordingly, no amortization expense was recognized in the
quarter ended March 31, 2006. Lower depreciation expense due to certain assets becoming fully
depreciated during 2005 also contributed to the decrease in the quarter ended March 31, 2006 as
compared to the same period in 2005.
17
As described further in Note 13 of the accompanying Notes to Consolidated Financial Statements
and in Liquidity and Capital Resources below, in May 2006, we purchased the rights in the United
States to Doral, a commercial product indicated for the treatment of insomnia, which occurs
frequently in patients with CNS diseases and disorders. We made a $2.5 million cash payment on the
transaction closing date and will make a second cash payment of $1.5 million within forty-five days
of our receipt of written notification from the FDA of the FDAs approval for an alternative source
to manufacture and supply the active ingredient Quazepam for Doral. The purchase price allocated
to the Doral product rights will be recorded to purchased technology and amortized on a
straight-line basis over the expected life of the Doral product rights.
Other Income and Expense Items
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|
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|
|
|
|
|
|
|
|
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|
|
|
Three Months Ended |
|
|
|
|
|
|
March 31, |
|
|
Increase/ |
|
|
|
2006 |
|
|
2005 |
|
|
(Decrease) |
|
|
|
(in $000's) |
|
Non-cash amortization of deemed discount on convertible debentures |
|
$ |
|
|
|
$ |
(108 |
) |
|
$ |
(108 |
) |
Interest income |
|
|
181 |
|
|
|
35 |
|
|
|
146 |
|
Interest expense |
|
|
|
|
|
|
(139 |
) |
|
|
(139 |
) |
Rental income (expense), net |
|
|
(6 |
) |
|
|
43 |
|
|
|
(49 |
) |
We did not record any non-cash amortization of deemed discount on convertible debentures for
the quarter ended March 31, 2006 as compared to $108,000 for the quarter ended March 31, 2005. The
deemed discount was fully amortized as of March 15, 2005 when the convertible debentures were
scheduled to mature. In March 2005, the maturity date of the convertible debentures was extended to
April 15, 2005, on which date we redeemed such convertible debentures in full in cash.
Interest income for the quarter ended March 31, 2006 increased by $146,000 from the quarter
ended March 31, 2005. The increase was due to higher cash balances resulting from the sale of our
non-core product lines in October 2005. Interest expense for the quarter ended March 31, 2006
decreased by $139,000 from the quarter ended March 31, 2005. The decrease was due to the pay off
during 2005 of the $2.2 million promissory note we issued to a wholly-owned subsidiary of
Sigma-Tau, Defiante Farmaceutica Lda (Defiante) in July 2004, and the redemption of our
convertible debentures in April 2005.
For the quarter ended March 31, 2006 we recorded $6,000 rental expense, net as compared to
$43,000 rental income, net for the quarter ended March 31, 2005. Rental income (expense), net,
arises primarily from the lease and sublease of our former headquarters facility in Hayward,
California. We have been notified by our tenant that they will be vacating the Hayward facility on
July 31, 2006 and we have begun the process to search for a new tenant. As of March 31, 2006 we are
obligated to pay rent on this facility of $5.6 million and our share of insurance, taxes and common
area maintenance through 2012. During the fourth quarter of 2005 we recognized an estimated loss
on this sublease of $415,000, as we may not be able to fully recover our costs over the remaining
term of our master lease. We regularly review our assumptions and estimates used to estimate the
loss on the sublease and will revise our estimated loss to reflect any changes in our assumptions.
The estimated loss was not adjusted during the quarter ended March 31, 2006.
Series B Preferred Stock Dividends
On January 3, 2006 we redeemed our outstanding Series B Preferred Stock with a cash payment of
$7.8 million, and accordingly did not incur any dividends on our Series B Preferred Stock in the
quarter ended March 31, 2006. Dividends on Series B Preferred Stock of $168,000 for the quarter
ended March 31, 2005 represented the 8% dividend that was paid quarterly to our Series B preferred
stockholders. The dividend for the quarter ended March 31, 2005 was paid in common stock. In March
2005, we reached agreement with all of the holders of the outstanding shares of our Series B
Preferred Stock to accept a private placement of 1,344,000 shares of our common stock having an
aggregate value equal to the dividends payable on April 1, 2005, July 1, 2005, October 1, 2005 and
January 1, 2006.
Liquidity and Capital Resources
We have funded our activities to date principally through various issuances of equity
securities and debt. In addition, we generated net cash proceeds of $22.5 million from the sale of
our non-core product lines in October 2005, after the repayment of the outstanding balance of a note payable of $2.1 million in connection with the sale and the
payment of $200,000 in estimated income taxes in March 2006.
At March 31, 2006, we had cash, cash equivalents and short-term investments of $15.2 million
compared to $26.6 million at December 31, 2005. The decrease in our cash balance is due primarily
to the redemption of our Series B Preferred Stock in cash
18
totaling $7.8 million in January 2006. At March 31, 2006, our working capital was $13.7
million compared to $16.1 million at December 31, 2005. The decrease in our working capital was
principally due to cash used to fund operations.
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. We
had issued the Series B Preferred Stock and warrants to purchase common stock in a January 2003
private placement. Pursuant to the terms of the Series B Preferred Stock, January 1, 2006 was the
first date on which we could redeem the Series B Preferred Stock. The Series B preferred
stockholders had the option to convert all or part of their Series B Preferred Stock into our
common stock prior to the redemption date. During the year ended December 31, 2005 we issued
1,353,118 shares of our common stock to the Series B stockholders upon conversion of 1,275 shares
of Series B Preferred Stock. We adjusted the carrying value of the 7,125 outstanding shares of
Series B Preferred Stock to its redemption amount of $7.8 million at December 31, 2005, and
classified it as a current liability. We also recorded a deemed dividend of $1.4 million in the
fourth quarter of 2005 representing the primary difference between the redemption amount and the
carrying value of the Series B Preferred Stock.
The redemption and conversion of the Series B Preferred Stock eliminated the Series B
Preferred Stock from our capital structure and with it the Series B cash dividend obligation of 10%
in each of 2006 and 2007 and 12% thereafter, the Series B liquidation preference and the Series B
restrictive covenants. The Series B stockholders retained warrants to purchase 3,025,921 shares of
our common stock at $0.94 per share that were acquired by the Series B stockholders in connection
with their purchase of the Series B Preferred Stock. In April and May 2006, 1,647,439 shares of
our common stock were issued upon the cash-less net exercise of 2,889,925 warrants issued to
certain Series B stockholders.
On March 29, 2005, we entered into a Series B Preferred Shareholder Agreement and Waiver with
all of the holders of the outstanding shares of our Series B Preferred Stock. Pursuant to such
agreement (i) the holders waived certain rights to receive additional dividends through March 31,
2006, (ii) the holders, with respect to dividends payable on April 1, 2005, July 1, 2005, October
1, 2005 and January 1, 2006, accepted as full and complete payment of all such dividend payments
the issuance by us to them in a private placement of shares of our common stock having an aggregate
value equal to the dividends otherwise payable on those dates, with the shares of common stock so
issued valued at fair market value based upon a ten-day weighted average trading price formula
through March 29, 2005, and (iii) the expiration date of the warrants to purchase shares of our
common stock held by the holders was extended for one year, until January 15, 2008. Accordingly, on
April 1, 2005, we issued 1,344,000 shares of common stock in a private placement to holders of our
Series B Preferred Stock.
In connection with the sale of our non-core products in October 2005, we paid off the
remaining $2.1 million balance of our $2.2 million secured promissory note to Defiante which was
issued in July 2004. The note, bearing interest at 9.83% per annum, required interest only payments
for the first twelve months, with monthly principal and interest payments thereafter through August
2008.
As of March 31, 2005, we had 8% convertible debentures with a face value of $4.0 million
outstanding, of which $2.0 million was issued to Defiante and $2.0 million was issued to SF Capital
Partners Ltd. (SFCP), an institutional investor. In March 2005, we entered into an amendment with
Defiante to the 8% convertible debenture issued by us in March 2002 in favor of Defiante, extending
the maturity date to April 15, 2005. In March 2005 we also entered into an amendment with SFCP to
the 8% convertible debenture issued by us in March 2002 in favor of SFCP, extending the maturity
date to April 15, 2005 and amending certain of the terms of our option to repay the SFCP debenture
in shares of common stock at the maturity date. We paid interest on the debentures at a rate of 8%
per annum on a quarterly basis. The debentures were convertible into 2,531,644 shares of our common
stock at a fixed conversion price of $1.58 per share (subject to adjustment for stock splits and
reclassifications). In April 2005, we redeemed both convertible debentures in full in cash totaling
$4.0 million, plus accrued interest of $94,000 to April 15, 2005.
The redemption of the Series B Preferred Stock in January 2006 and the retirement of our
outstanding debt and debentures during 2005 improved our capital structure and eliminated dividends
on the Series B Preferred Stock and interest and amortization on the retired debt and debentures.
Dividends related to the Series B Preferred Stock, interest on the retired debt and debentures, and
amortization of deemed discount on the debentures totaled $493,000 for the quarter ended March 31,
2005.
In May 2006, we purchased the rights in the United States to Doral (Quazepam) from MedPointe
pursuant to an Assignment and Assumption Agreement (Agreement). Doral is a commercial product
indicated for the treatment of insomnia, which occurs frequently in patients with CNS diseases and
disorders. We made a $2.5 million cash payment on the transaction closing date and will make a
second cash payment of $1.5 million within forty-five days of our receipt of written notification
from the FDA of the FDAs approval for an alternative source to manufacture and supply the active
ingredient Quazepam for Doral. In addition, under the terms of the Agreement, we received all
finished goods inventories of Doral existing at the closing date and assumed an obligation to pay a
19
royalty to IVAX Research, Inc. on net sales of Doral. MedPointe is obligated for all product
returns, Medicaid rebates, and chargebacks on sales of Doral prior to the closing date. We entered
into a separate supply agreement with Medpointe to supply Doral for an initial term of three years.
The supply agreement may be extended for an additional term of three years upon the written
consent of both parties prior to the end of the initial term. We will promote Doral to
neurologists with our existing sales organization. The purchase price allocated to the Doral
product rights will be recorded to purchased technology and amortized on a straight-line basis over
the expected life of the Doral product rights. Gross ex-factory sales of Doral for the year ended
December 31, 2005 totaled $1.1 million.
Based on our internal forecasts and projections, we believe that our cash resources at March
31, 2006 will be sufficient to fund our operations through at least March 31, 2007, unless a
substantial portion of our cash is used for additional product acquisitions and 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 acquire 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.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at March 31, 2006 has not changed materially from December 31,
2005, 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, 2005.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure. In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives, and management
is required to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level.
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Not applicable
ITEM 1A. RISK FACTORS
Our exposure to the risks discussed in our Annual Report on Form 10-K for the year ended
December 31, 2005, in the section Risk Factors, has not changed materially at March 31, 2006.
20
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable
ITEM 5. OTHER INFORMATION
Not applicable
ITEM 6. EXHIBITS
|
|
|
Exhibit No. |
|
Description |
31
|
|
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. |
21
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
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QUESTCOR PHARMACEUTICALS, INC.
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Date: May 12, 2006 |
By: |
/s/ JAMES L. FARES
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James L. Fares |
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President and Chief Executive Officer |
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By: |
/s/ GEORGE STUART
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George Stuart |
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Vice President, Finance and Chief Financial Officer |
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22
Exhibit Index
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Exhibit No. |
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Description
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31
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Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32*
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Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002. |
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* |
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These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
exv31
EXHIBIT 31
Certification of Chief Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, James L. Fares, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the registrant and have:
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a) |
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designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and |
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c) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants internal
control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
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a) |
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all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and |
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b) |
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any fraud, whether or not material, that involves management or other employees who have
a significant role in the registrants internal control over financial reporting. |
Date: May
12, 2006
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/s/ JAMES L. FARES
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James L. Fares |
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Chief Executive Officer |
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Certification of Chief Financial Officer
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. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for
the registrant and have:
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a) |
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designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such evaluation;
and |
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c) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants internal
control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
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a) |
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all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information; and |
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b) |
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any fraud, whether or not material, that involves management or other employees who have
a significant role in the registrants internal control over financial reporting. |
Date: May 12, 2006
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/s/ GEORGE STUART
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George Stuart |
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Chief Financial Officer |
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exv32
EXHIBIT 32
CERTIFICATIONS
On
May 12, 2006, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for
the quarter ended March 31, 2006 (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
following certifications are being made to accompany the Form 10-Q:
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Questcor Pharmaceuticals, Inc. (the Company) hereby certifies, to such
officers knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2006 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Dated: May 12, 2006 |
/s/ JAMES L. FARES
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James L. Fares |
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Chief Executive Officer |
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The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.
Certification of Chief Financial Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Questcor Pharmaceuticals, Inc. (the Company) hereby certifies, to such
officers knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended March 31, 2006 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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Dated: May 12, 2006 |
/s/ GEORGE STUART
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George Stuart |
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Chief Financial Officer |
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The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.