e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934. |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
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33-0476164 |
(State or other jurisdiction
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(I.R.S. Employer |
of incorporation or organization)
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Identification No.) |
3260 Whipple Road
Union City, CA 94587-1217
(Address of Principal Executive Offices)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 400-0700
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter prior that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark whether Registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
At November 2, 2006 there were 57,235,606 shares of the Registrants common stock, no par
value per share, outstanding.
QUESTCOR PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
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September 30, |
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December 31, |
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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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$ |
4,366 |
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$ |
20,438 |
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Short-term investments |
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4,911 |
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6,139 |
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Accounts receivable, net of allowance for doubtful accounts of $22 and $84 at
September 30, 2006 and December 31, 2005, respectively |
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2,022 |
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725 |
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Inventories, net |
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2,901 |
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1,577 |
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Prepaid expenses and other current assets |
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1,279 |
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710 |
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Total current assets |
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15,479 |
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29,589 |
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Property and equipment, net |
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601 |
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655 |
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Purchased technology, net |
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2,514 |
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Goodwill |
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299 |
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299 |
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Deposits and other assets |
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716 |
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805 |
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Total assets |
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$ |
19,609 |
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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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$ |
1,860 |
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$ |
1,505 |
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Accrued compensation |
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890 |
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709 |
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Sales-related reserves |
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3,177 |
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2,581 |
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Other accrued liabilities |
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533 |
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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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6,460 |
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13,468 |
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Lease termination and deferred rent liabilities |
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1,807 |
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1,350 |
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Other non-current liabilities |
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20 |
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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 September 30, 2006 and December 31, 2005
(aggregate liquidation preference of $10,000 at September 30, 2006 and December
31, 2005) |
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5,081 |
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5,081 |
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Shareholders equity: |
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Common stock, no par value, 105,000,000 shares authorized; 57,216,721 and
54,461,291 shares issued and outstanding at September 30, 2006 and December 31,
2005, respectively |
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92,157 |
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90,571 |
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Accumulated deficit |
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(85,920 |
) |
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(79,147 |
) |
Accumulated other comprehensive gain (loss) |
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4 |
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(2 |
) |
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Total shareholders equity |
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6,241 |
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11,422 |
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Total liabilities and shareholders equity |
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$ |
19,609 |
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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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Nine Months Ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Net product sales |
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$ |
4,045 |
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$ |
3,558 |
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$ |
9,384 |
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$ |
12,346 |
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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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945 |
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522 |
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2,223 |
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2,297 |
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Selling, general and administrative |
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4,171 |
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2,298 |
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12,582 |
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7,140 |
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Research and development |
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544 |
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536 |
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1,632 |
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1,597 |
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Depreciation and amortization |
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94 |
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319 |
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218 |
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953 |
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Total operating costs and expenses |
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5,754 |
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3,675 |
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16,655 |
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11,987 |
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Income (loss) from operations |
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(1,709 |
) |
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(117 |
) |
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(7,271 |
) |
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359 |
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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 |
) |
Interest income |
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137 |
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29 |
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469 |
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87 |
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Interest expense |
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(38 |
) |
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(247 |
) |
Other income, net |
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51 |
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5 |
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51 |
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6 |
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Rental income (expense), net |
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67 |
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(22 |
) |
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181 |
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Total other income (expense) |
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188 |
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63 |
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498 |
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(81 |
) |
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Net income (loss) |
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(1,521 |
) |
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(54 |
) |
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(6,773 |
) |
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278 |
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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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504 |
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Net loss applicable to common shareholders |
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$ |
(1,521 |
) |
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$ |
(222 |
) |
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$ |
(6,773 |
) |
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$ |
(310 |
) |
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Net loss per share applicable to common shareholders basic and diluted |
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$ |
(0.03 |
) |
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$ |
0.00 |
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$ |
(0.12 |
) |
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$ |
(0.01 |
) |
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Shares used in computing net loss per share applicable to common
shareholders basic and diluted |
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56,870 |
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52,813 |
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55,841 |
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52,236 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Nine Months Ended |
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September 30, |
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2006 |
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2005 |
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OPERATING ACTIVITIES |
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Net income (loss) |
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$ |
(6,773 |
) |
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$ |
278 |
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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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828 |
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19 |
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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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218 |
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|
|
953 |
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Changes in operating assets and liabilities: |
|
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Accounts receivable |
|
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(1,297 |
) |
|
|
366 |
|
Inventories |
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|
(1,282 |
) |
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(16 |
) |
Prepaid expenses and other current assets |
|
|
(569 |
) |
|
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(335 |
) |
Accounts payable |
|
|
355 |
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(266 |
) |
Accrued compensation |
|
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181 |
|
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(325 |
) |
Sales-related reserves |
|
|
596 |
|
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|
887 |
|
Other accrued liabilities |
|
|
(100 |
) |
|
|
(103 |
) |
Income taxes payable |
|
|
(200 |
) |
|
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Other non-current liabilities |
|
|
457 |
|
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28 |
|
|
|
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Net cash flows provided by (used in) operating activities |
|
|
(7,586 |
) |
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|
1,594 |
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|
|
|
|
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INVESTING ACTIVITIES |
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Purchase of property and equipment |
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(92 |
) |
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(22 |
) |
Purchase of short-term investments |
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(9,606 |
) |
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Maturities of short-term investments |
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|
10,840 |
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Acquisition of purchased technology |
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(2,628 |
) |
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|
(2,000 |
) |
Proceeds from sale of equipment |
|
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|
1 |
|
Decrease in other assets |
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|
89 |
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80 |
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|
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Net cash flows used in investing activities |
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|
(1,397 |
) |
|
|
(1,941 |
) |
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FINANCING ACTIVITIES |
|
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Issuance of common stock, net |
|
|
758 |
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|
129 |
|
Redemption of Series B preferred stock |
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|
(7,841 |
) |
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Short-term borrowings |
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|
191 |
|
Repayment of short-term and long-term debt and capital lease obligation |
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|
(6 |
) |
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|
(361 |
) |
Redemption of convertible debentures |
|
|
|
|
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|
(4,000 |
) |
|
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|
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Net cash flows used in financing activities |
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|
(7,089 |
) |
|
|
(4,041 |
) |
|
|
|
|
|
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Decrease in cash and cash equivalents |
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|
(16,072 |
) |
|
|
(4,388 |
) |
Cash and cash equivalents at beginning of period |
|
|
20,438 |
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|
8,729 |
|
|
|
|
|
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Cash and cash equivalents at end of period |
|
$ |
4,366 |
|
|
$ |
4,341 |
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|
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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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$ |
84 |
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Common stock issued in lieu of quarterly cash dividends on Series B preferred stock |
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$ |
|
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|
$ |
672 |
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Common stock issued upon conversion of Series B preferred stock and accrued dividends
for Series B stock |
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$ |
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$ |
24 |
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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 three month period ended September 30, 2006, Questcor owned two
commercial CNS products, H.P. Acthar Gel® (Acthar) and Doral®. The Company
acquired the rights to Doral (quazepam) in the United States in May 2006 as described further in
Note 13. Acthar (repository corticotropin injection) is an injectable drug that is approved for the
treatment of certain CNS disorders with an inflammatory component, including the treatment of
flares associated with multiple sclerosis (MS), and is also used in treating patients with
infantile spasm, an epileptic syndrome. Doral is indicated for the treatment of insomnia,
characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning
awakenings, which occurs frequently in patients with CNS diseases and disorders. The Companys
strategy is to (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 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. 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 United States generally accepted accounting principles and applicable Securities
and Exchange Commission regulations for interim financial information. These financial statements
do not include all of the information and footnotes required by United States generally accepted
accounting principles for complete financial statements. The unaudited financial statements should
be read in conjunction with the audited financial statements and related footnotes included in the
Companys Annual Report on Form 10-K for the year ended December 31, 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 three and nine month periods ended September 30, 2005 include the net
product sales and direct operating costs and expenses of the divested product lines and
VSL#3®. Because the divested product lines were part of a larger cash-flow generating
group and did not represent a separate operation of the Company, the divested product lines were
not reported as discontinued operations. The Companys agreement to promote VSL#3 terminated in
January 2005.
On June 9, 2006, the Company filed a shelf registration statement on Form S-3 with the
Securities and Exchange Commission, which was declared effective by the SEC on October 5, 2006.
The shelf registration statement will enable the Company to offer and sell up to $25 million of
common shares or debt securities from time to time in one or more offerings. The terms of any such
future offering would be established at the time of such offering.
6
Based on the Companys internal forecasts and projections, the Company believes that its cash
resources at September 30, 2006 will be sufficient to fund its operations through at least
September 30, 2007, unless a substantial portion of its existing cash is used to acquire, license,
develop, and co-promote products for CNS disorders or its revenues are significantly less than it
expects. The Companys future funding requirements will depend on many factors, including: the
implementation of its business strategy; the timing and extent of product sales; the acquisition
and licensing of products, technologies or compounds, if any; the Companys ability to manage
growth; competing technological and market developments; costs involved in filing, prosecuting,
defending and enforcing patent and intellectual property claims; the receipt of licensing or
milestone fees from current or future collaborative and license agreements, if established; the
timing of regulatory approvals; any expansion or acceleration of its development programs; and
other factors. If the Companys cash resources and its revenues are not sufficient to meet its
obligations, or if the Company has insufficient funds to acquire additional products or expand its
operations, the Company will seek to raise additional capital through public or private equity
financing or from other sources. However, traditional asset based debt financing has not been
available on acceptable terms. Additionally, the Company may seek to raise additional capital
whenever conditions in the financial markets are favorable, even if the Company does not have an
immediate need for additional cash at that time. There can be no assurance that the Company will be
able to obtain additional funds on desirable terms or at all.
2. SHARE-BASED COMPENSATION
Effective January 1, 2006, the Company adopted the fair value recognition provisions of
Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based Payment
(SFAS No. 123(R)), using the modified-prospective transition method. Under that transition
method, share-based compensation cost related to employees and non-employee members of the
Companys board of directors for the three and nine month periods ended September 30, 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 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 (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).
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 and nine month
periods ended September 30, 2006 as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
September 30, 2006 |
|
|
September 30, 2006 |
|
Cost of product sales |
|
$ |
12 |
|
|
$ |
23 |
|
Selling, general and administrative |
|
|
348 |
|
|
|
676 |
|
Research and development |
|
|
11 |
|
|
|
21 |
|
|
|
|
|
|
|
|
Total |
|
$ |
371 |
|
|
$ |
720 |
|
|
|
|
|
|
|
|
Share-based compensation cost related to employees and non-employee members of the board of
directors is recognized as expense, net of estimated pre-vesting forfeitures, ratably over the
vesting period of the award. The Company has estimated an annual pre-vesting forfeiture rate of
12% for a typical stock award with a four year vesting term. The pre-vesting forfeiture rate was
estimated based on historical data. No tax benefit has been recognized related to share-based
compensation expense since the Company has incurred operating losses. The Company has established a
full valuation allowance to offset all potential tax benefits associated with its deferred tax
assets.
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 disclosure of net income
(loss) applicable to common shareholders as if the fair-value-based method defined in SFAS No. 123
had been applied. In the pro forma information for periods prior to 2006, the Company accounted
for pre-vesting forfeitures as they occurred. The Companys operating results for prior periods
have not been restated. The following table presents the pro forma effect on net income (loss)
applicable to common shareholders and net income (loss) per share applicable to common shareholders
as if the Company had applied
7
the fair value recognition provisions of SFAS No. 123 to share-based compensation during the
three and nine month periods ended September 30, 2005 (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
September 30, 2005 |
|
|
September 30, 2005 |
|
Net loss applicable to common shareholders, as reported |
|
$ |
(222 |
) |
|
$ |
(310 |
) |
Add: Share-based employee compensation expense included in reported net loss
applicable to common shareholders |
|
|
1 |
|
|
|
4 |
|
Deduct: Share-based employee compensation expense determined under SFAS No. 123 |
|
|
(113 |
) |
|
|
(341 |
) |
|
|
|
|
|
|
|
Net loss applicable to common shareholders, pro forma |
|
$ |
(334 |
) |
|
$ |
(647 |
) |
|
|
|
|
|
|
|
Basic and diluted net loss per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
As reported |
|
$ |
0.00 |
|
|
$ |
(0.01 |
) |
Pro forma |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
The Company had the following share-based compensation arrangements during the three and nine
month periods ended September 30, 2006: an Equity Incentive Award Plan that provides for the grant
of equity incentives to employees, members of the Companys board of directors, and consultants; an
Employee Stock Option Plan that provided 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 plans
are more fully described below. The Employee Stock Option Plan, Non-Employee Directors Equity
Incentive Plan, and Employee Stock Purchase Plan are also described in Note 12 of the Companys
2005 Annual Report on Form 10-K.
In May 2006, the Companys shareholders approved the adoption of the 2006 Equity Incentive
Award Plan. Upon the adoption of the Equity Incentive Award Plan, the Company ceased grants under
the Companys Employee Stock Option Plan. The Equity Incentive Award Plan provides for the grant of
incentive stock options, non-qualified stock options, restricted stock grants, unrestricted stock
grants, stock appreciation rights, restricted stock units and dividend equivalents. Equity
incentives under the Equity Incentive Award Plan and the Employee Stock Option Plan generally
include four year vesting periods, an exercise price that equals the fair market value of the
Companys common stock on the date of grant, and maximum terms of ten years. Restricted stock
awards entitle the recipient to full dividend and voting rights. Nonvested shares are restricted
as to disposition and subject to forfeiture under certain circumstances. The aggregate number of
shares of common stock authorized for issuance under the Equity Incentive Award Plan is 6,250,000
shares. The Companys Non-Employee Directors Equity Incentive Plan provides for the granting of
25,000 stock options to purchase common stock upon appointment as a non-employee director and
15,000 stock options each January thereafter for continuing service upon reappointment. Such stock
option grants vest over four years. In addition, 10,000 stock options are granted to members of one
or more committees of the board of directors and an additional 7,500 stock options to chairmen of
one or more committees. Such stock option grants are fully vested at the time of grant. All stock
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 stock 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 stock options awarded to employees and non-employee members of the Companys
board of directors during the three and nine month periods ended September 30, 2006 and 2005 was
estimated using the Black-Scholes option valuation model. The Black-Scholes option valuation
assumptions noted in the following table are the actual assumptions used for stock options awarded
during the three month periods ended September 30, 2006 and 2005 and the weighted average
assumptions for stock options awarded during the nine month periods ended September 30, 2006 and
2005. Expected volatility is based on the historical volatility of the Companys stock. The
expected term for the three and nine month periods ended September 30, 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 and nine month periods ended September 30,
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 stock
options granted are expected to be outstanding. The risk-free interest rate is based on the U.S.
Treasury yield curve.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Expected volatility |
|
|
91 |
% |
|
|
63 |
% |
|
|
96 |
% |
|
|
68 |
% |
Expected term (in years) |
|
|
6.25 |
|
|
|
4.0 |
|
|
|
6.25 |
|
|
|
4.0 |
|
Risk-free interest rate |
|
|
4.6 |
% |
|
|
4.0 |
% |
|
|
4.8 |
% |
|
|
4.1 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
The weighted-average grant-date fair value of the stock options granted to employees and
non-employee members of the Companys board of directors was $1.35 and $0.26 during the three month
periods ended September 30, 2006 and 2005, respectively, and $0.98 and $0.26 during the nine month
periods ended September 30, 2006 and 2005, respectively.
A summary of stock options outstanding as of December 31, 2005 and changes during the nine
month period ended September 30, 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
Weighted- |
|
Remaining |
|
|
|
|
|
|
|
|
Average |
|
Contractual |
|
Aggregate |
|
|
Stock |
|
Exercise |
|
Term |
|
Intrinsic Value |
|
|
Options |
|
Price |
|
(in years) |
|
(in thousands) |
Outstanding at December 31, 2005 |
|
|
6,402,074 |
|
|
$ |
0.76 |
|
|
|
7.84 |
|
|
|
|
|
Granted |
|
|
2,174,750 |
|
|
|
1.24 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(553,306 |
) |
|
|
0.92 |
|
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
(680,573 |
) |
|
|
1.46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at September 30, 2006 |
|
|
7,342,945 |
|
|
$ |
0.83 |
|
|
|
8.10 |
|
|
$ |
5,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and exercisable at September 30, 2006 |
|
|
2,707,153 |
|
|
$ |
0.79 |
|
|
|
6.94 |
|
|
$ |
2,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 stock options at September 30, 2006 for those
stock options for which the quoted market price was in excess of the exercise price (in-the-money
options). The total intrinsic value of stock options exercised was $202,000 and $340,000 for the
three and nine month periods ended September 30, 2006, respectively. The total intrinsic value of
stock options exercised during the three and nine month periods ended September 30, 2005 was not
material. Net cash proceeds from the exercise of stock options were $205,000 and $508,000 for the
three and nine month periods ended September 30, 2006, respectively. Net cash proceeds from stock
options exercised during the three and nine month periods ended September 30, 2005 were not
material. The Company distributes newly issued shares in exchange for the net cash proceeds when
stock options are exercised and has not repurchased, and does not expect to repurchase, shares
subsequent to their issuance upon stock option exercise.
The fair value of restricted stock is calculated under the intrinsic value method. A summary
of restricted stock outstanding as of December 31, 2005 and changes during the nine month period
ended September 30, 2006 are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
Restricted |
|
|
Grant Date Fair |
|
|
|
Stock |
|
|
Value |
|
Nonvested shares at December 31, 2005 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
127,811 |
|
|
|
1.69 |
|
Vested |
|
|
|
|
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested shares at September, 2006 |
|
|
127,811 |
|
|
$ |
1.69 |
|
|
|
|
|
|
|
|
As of September 30, 2006, $2.0 million of total unrecognized compensation cost related to
unvested grants of stock options and awards of restricted stock is expected to be recognized over a
weighted-average period of 2.9 years.
The Employee Stock Purchase Plan provides for eligible employees to make payroll deductions of
1% to 15% of their earnings to purchase the Companys common stock during an offering period. The
purchase price of the common stock is 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 a purchase
date within the offering period. Purchase dates are February 28, May 31, August 31, and November
30. The Company began a new offering period on September 1, 2006. The offering period has a term
of twelve months, subject to a reset feature designated under the Employee Stock Purchase Plan.
Under the reset feature, if the fair market value of the Companys common stock on a purchase date
during the offering period is lower than the fair market value on the offering date of that same
offering period, the offering period will be automatically terminated following the purchase of
shares on the purchase date and a new offering period will commence on the next day after the
purchase date. The new offering period will continue for a period of twelve months, subject to the
reset provision.
9
The Company utilized the Black-Scholes option valuation model in connection with determining
the fair value of each option element of the Companys Employee Stock Purchase Plan during the
three and nine month periods ended September 30, 2006 and 2005. The Black-Scholes option valuation
assumptions noted in the following table are the weighted average assumptions for the three and
nine month periods ended September 30, 2006 and 2005. Expected volatility is based on historical
volatility of the Companys common stock. The expected term represents the life of the option
element. The risk-free interest rate is based on the U.S. Treasury yield.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Expected volatility |
|
|
84 |
% |
|
|
63 |
% |
|
|
88 |
% |
|
|
63 |
% |
Expected term (in years) |
|
|
0.36 |
|
|
|
0.25 |
|
|
|
0.32 |
|
|
|
0.25 |
|
Risk-free interest rate |
|
|
5.1 |
% |
|
|
4.0 |
% |
|
|
5.0 |
% |
|
|
3.8 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value of each option element under the Companys Employee Stock
Purchase Plan was $0.42 and $0.25 for the three month periods ended September 30, 2006 and 2005,
respectively, and $0.30 and $0.22 for the nine month periods ended September 30, 2006 and 2005,
respectively. As of September 30, 2006, $0.2 million of total unrecognized compensation cost
related to the Companys Employee Stock Purchase Plan is expected to be recognized over the
remaining length of the current offering period.
Cash received from employee contributions to the Employee Stock Purchase Plan were $101,000
and $52,000 for the three month periods ended September 30, 2006 and 2005, respectively, and
$260,000 and $116,000 for the nine month periods ended September 30, 2006 and 2005, respectively.
Shares issued through the Employee Stock Purchase Plan totaled 150,892 and 78,526 during the three
month periods ended September 30, 2006 and 2005, respectively, and 408,373 and 242,710 during the
nine month periods ended September 30, 2006 and 2005, respectively. In May 2006, the Companys
shareholders approved an amendment to the 2003 Employee Stock Purchase Plan to increase the total
number of shares authorized for issuance from 900,000 shares to 2,400,000 shares. As of September
30, 2006, the Company had 1,369,214 shares reserved for future issuance under the Employee Stock
Purchase Plan.
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 Company issues credit memoranda for expired product returned within six months beyond the
expiration date. The credit memoranda is equal to the sales value of the product returned and the
estimated amount of such credit memoranda is recorded as a liability with a corresponding reduction
in gross product sales. This reserve is reduced as credit memoranda are issued, with an offset to
accounts receivable. Returns are subject to inspection prior to acceptance. The Company records
estimated sales reserves for expected credit memoranda based upon historical return rates by
product, analysis of return merchandise authorizations, returns received, sales patterns, current
inventory on hand at wholesalers, changes in prescription demand, and other factors such as shelf
life. The Company records estimated sales reserves for Medicaid rebates and government chargebacks
by analyzing historical rebate and chargeback percentages, allowable Medicaid prices, and other
factors, as required. Significant judgment is inherent in the selection of assumptions and in the
interpretation of historical experience as well as the identification of external and internal
factors affecting the estimate of reserves for product returns, Medicaid rebates and government
chargebacks. The Company routinely assesses the historical returns and other experience including
customers compliance with return goods policy and adjusts its reserves as appropriate.
Reserves for government chargebacks, Medicaid rebates, and product returns for credit
memoranda related to Acthar and Doral were $3.0 million and $2.1 million at September 30, 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 the financial obligation associated with all Medicaid
rebates and government chargebacks on its sales of these products through October 17, 2005. The
Company is also responsible for the financial obligation associated with product returns on its
sales of Nascobal and Ethamolin through October 17, 2005, but only to the extent the returns
10
were authorized by January 31, 2006. The Company had total sales-related reserves related to
its financial obligations associated with these products of $169,000 and $478,000 at September 30,
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 $9.3 million and $26.6 million at September 30, 2006 and December 31, 2005,
respectively. Cash equivalents are invested in money market funds and commercial paper. Short-term
investments are invested in corporate bonds and commercial paper. The fair value of the funds
approximated cost.
11
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist
of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
2,319 |
|
|
$ |
1,335 |
|
Work in process |
|
|
|
|
|
|
|
|
Finished goods |
|
|
686 |
|
|
|
342 |
|
Less allowance for excess and obsolete inventories |
|
|
(104 |
) |
|
|
(100 |
) |
|
|
|
|
|
|
|
|
|
$ |
2,901 |
|
|
$ |
1,577 |
|
|
|
|
|
|
|
|
6. PURCHASED TECHNOLOGY AND GOODWILL
Purchased technology of $2.5 million at September 30, 2006 related to the May 2006 acquisition
of the Doral product rights. The Doral purchased technology is being amortized on a straight-line
basis over its expected life of 15 years. Accumulated amortization for the Doral purchased
technology was $72,000 as of September 30, 2006.
The Company monitors the carrying value of the goodwill through annual impairment tests or
more frequently if indicators of potential impairment exist. As of September 30, 2006 and December
31, 2005, no impairment had been indicated.
7. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
In July 2000, the Company entered into an agreement to sublease 15,000 square feet of
laboratory and office space including subleasing its laboratory equipment at its 30,000 square foot
Hayward, California facility. Due to the termination of the Companys then existing drug discovery
programs, the space and equipment were no longer needed. In May 2001, the sublessee of the Hayward
facility subleased and fully occupied the entire 30,000 square foot facility after the Company
relocated to its current facility in Union City, California. The sublease expired in July 2006 and
the Company is searching for a new tenant. The Companys master lease on the Hayward facility
expires in November 2012. As of September 30, 2006 the Company is obligated to pay rent on the
Hayward facility of $5.3 million and its share of insurance, taxes and common area maintenance
through the expiration of its master lease. During the fourth quarter of 2005, the Company
recognized a loss of $415,000 on the master lease and a liability of $1.1 million as of December
31, 2005 related to future lease obligations as the Company determined that it may not be able to
fully recover its lease cost over the period from January 1, 2006 through the expiration of the
master lease. The fair value of the liability was determined using a credit-adjusted risk-free rate
to discount the estimated future net cash flows, consisting of the minimum lease payments under the
master lease, net of estimated sublease rental income that could reasonably be obtained from the
property. The Company is also required to recognize an on-going accretion expense representing the
difference between the undiscounted net cash flows and the discounted net cash flows over the
remaining term of the Hayward master lease using the interest method. The accretion amount
represents an on-going adjustment to the estimated liability. The Company reviews the assumptions
used in determining the estimated liability quarterly and revises its estimate of the liability to
reflect changes in circumstances. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the accompanying
Consolidated Statements of Operations. During the nine month period ended September 30, 2006, the
Company revised its estimate of the liability and recorded an additional loss of $219,000. During
the three and nine month periods ended September 30, 2006, the Company recognized expense of
$65,000 and $382,000, respectively, related to the Hayward facility. As of September 30, 2006, the
estimated liability related to the Hayward facility totaled $1.6 million and is included in Lease
Termination and Deferred Rent Liabilities in the accompanying Consolidated Balance Sheets.
The Company, as permitted under California law and in accordance with its Bylaws, indemnifies
its officers and directors for certain events or occurrences while the officer or director is or
was serving at the Companys request in such capacity. The potential future indemnification limit
is to the fullest extent permissible under California law; however, the Company has a director and
officer insurance policy that limits its exposure and may enable it to recover a portion of any
future amounts paid. The Company believes the fair value of these indemnification agreements is
minimal. Accordingly, the Company has no liabilities recorded for these agreements as of September
30, 2006 and December 31, 2005.
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.
12
8. NET INCOME (LOSS) PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
Basic and diluted net income (loss) per share applicable to common shareholders is based on
net income (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 three and nine month periods ended September 30, 2006 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 September
30, 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
7,342,945 common shares, nonvested restricted stock awards of 127,811 common shares, an estimated
26,000 common shares to be issued under the Employee Stock Purchase Plan in the current purchase
period, 2,155,715 convertible preferred shares, placement agent unit options for 127,676 common
shares and warrants to purchase 613,938 common shares.
9. WARRANT TRANSACTIONS
In March 2006, warrants to purchase 859,494 shares of the Companys common stock at $1.70 per
share expired unexercised. In April 2006, warrants to purchase 18,500 and 26,000 shares of the
Companys common stock at $0.64 per share were exercised and expired, respectively. In April and
May 2006, 1,647,440 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.
10. SERIES B CONVERTIBLE PREFERRED STOCK
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. 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, 1,647,440 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 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
13
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. The Company recorded a cost reimbursement of
$44,000 in the nine month period ended September 30, 2005, which reduced selling, general and
administrative expense. During the nine month period ended September 30, 2005, the Company paid
$203,000 to Sigma-Tau Pharmaceuticals for the purchase of VSL#3 product and access fees relating to
activity under the promotion agreement prior to its expiration. There was no VSL#3 revenue for the
three month periods ended September 30, 2006 and 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
($000s) |
|
|
($000s) |
|
Net income (loss) |
|
$ |
(1,521 |
) |
|
$ |
(54 |
) |
|
$ |
(6,773 |
) |
|
$ |
278 |
|
Change in unrealized gains on available-for-sale securities |
|
|
7 |
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
(1,514 |
) |
|
$ |
(54 |
) |
|
$ |
(6,767 |
) |
|
$ |
278 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13. ACQUISITION OF DORAL
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 is
promoting Doral to neurologists with its existing sales organization and commenced shipments in
late May 2006. The purchase price, including acquisition costs, allocated to the Doral product
rights was recorded to purchased technology and is being amortized on a straight-line basis over
fifteen years, the expected life of the Doral product rights. MedPointes sales of Doral, before
product returns, rebates and chargebacks, for the year ended December 31, 2005 totaled $1.1
million.
14. RECENTLY ISSUED ACCOUNTING STANDARDS
In June 2006, the Financial Accounting Standards Board (FASB) issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement No. 109 (FIN
48). This Interpretation clarifies the accounting for uncertainty in income taxes recognized in a
companys financial statements in accordance with FASB Statement No. 109, Accounting for Income
Taxes. FIN 48 requires that a company determine whether it is more likely than not that a tax
position will be sustained upon examination by the appropriate taxing authority. If a tax position
meets the more-likely-than-not recognition criteria, FIN 48 requires the tax position be measured
at the largest amount of benefit that is greater than 50 percent likely of being realized upon
ultimate
14
settlement. FIN 48 is effective for fiscal years beginning after December 15, 2006. The
Company does not believe that the adoption of FIN 48 will have a material impact on its results of
operations or financial position.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (FAS 157). FAS 157
defines fair value, establishes a market-based framework or hierarchy for measuring fair value, and
expands disclosures about fair value measurements. FAS 157 is applicable whenever another
accounting pronouncement requires or permits assets and liabilities to be measured at fair value.
FAS 157 does not expand or require any new fair value measures. The provisions of SFAS No. 157 are
to be applied prospectively and are effective for financial statements issued for fiscal years
beginning after November 15, 2007. The Company is currently evaluating what effect, if any, the
adoption of SFAS No. 157 will have on the Companys consolidated results of operations and
financial position.
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, Item 1A
Risk Factors, as well as factors discussed in any documents incorporated by reference herein or
therein. Whenever used in this Quarterly Report, the terms Questcor, Company, we, our,
ours, and us refer to Questcor Pharmaceuticals, Inc. and its consolidated 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 three month period
ended September 30, 2006, we owned two commercial CNS products, H.P. Acthar Gel (Acthar), and
Doral. We acquired the rights to Doral (quazepam) in May 2006. Acthar (repository corticotropin
injection) is an injectable drug that is approved for the treatment of certain CNS disorders with
an inflammatory component, including the treatment of flares associated with multiple sclerosis
(MS), and is also used in treating patients with infantile spasm, an epileptic syndrome. Doral is
indicated for the treatment of insomnia, characterized by difficulty in falling asleep, frequent
nocturnal awakenings, and/or early morning awakenings, which occurs frequently in patients with CNS
diseases and disorders.
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. In January 2005, our agreement to promote and sell VSL#3 expired in
accordance with its terms. Our results of operations and cash flows for the three and nine month
periods ended September 30, 2005 include the net product sales and direct operating costs and
expenses of the divested product lines and VSL#3. Because the divested product lines were part of a
larger cash-flow generating group and did not represent a separate operation, the divested product
lines were not reported as discontinued operations. In addition, as previously mentioned above, in
May 2006 we completed the acquisition of Doral from MedPointe Healthcare Inc (MedPointe). As
consideration for the rights to Doral in the United States, we paid MedPointe $2.5 million in cash
upon the closing of the transaction and will make a future cash payment of $1.5 million after the
approval of an alternative source to manufacture and supply the active ingredient for Doral.
Expenses
we incur for medical and regulatory affairs activities, our preliminary evaluation
of certain development opportunities, and our filing of
our supplemental new drug application for Acthar for the treatment of
infantile spasms are classified as Research and Development expenses in the
accompanying Consolidated Statements of Operations. In August 2006, the supplemental new drug application was accepted for review by the FDA. We
expect the FDA to take action on the supplemental new drug application in the second quarter of
2007. We expect our research and development spending
to increase in the future as we implement our CNS strategy.
15
We have incurred an accumulated deficit of $85.9 million at September 30, 2006. At September
30, 2006, we had $9.3 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 and
the establishment of strategic alliances and collaborative arrangements.
Critical Accounting Policies
Our managements discussion and analysis of our financial condition and results of operations
is based upon our consolidated financial statements, which have been prepared in accordance with
United States generally accepted accounting principles. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate our
estimates, including those related to sales reserves, product returns, bad debts, inventories,
intangible assets and share-based compensation. We base our estimates on 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.
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 product return policy, such differences would be accounted for in the period in which
they become known. To date, actual amounts have been consistent with our estimates.
We establish a reserve for the sales value of expired product expected to be returned with a
corresponding reduction in gross product sales. The reserve is reduced as credit memoranda are
issued, with an offset to accounts receivable. In estimating the return rate for expired product,
we primarily analyze historical returns. We also consider sales patterns, current inventory on hand at wholesalers
and the remaining shelf life of that inventory, and changes in demand measured by
prescriptions or other data as provided by an independent third party source 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 return policy, and we adjust our reserves as
appropriate.
In estimating Medicaid rebates, we match the actual rebates to the quantity of product sold by
pharmacies to arrive at an actual rebate percentage. This historical percentage is used to estimate
a rebate percentage that is applied to the sales to which the rebates apply to arrive at the
estimated rebate reserve for the period. We also consider allowable prices by Medicaid. In
estimating government chargeback reserves, we analyze actual chargeback amounts and apply
historical chargeback rates to sales to which chargebacks apply. We routinely assess our experience
with Medicaid rebates and government chargebacks and adjust the reserves accordingly. For qualified
customers, we grant payment terms of 2%, net 30 days. Allowances for cash discounts are estimated
based upon the amount of trade accounts receivable subject to the cash discounts.
Total sales-related reserves related to Acthar and Doral were $3.0 million and $2.1 million at
September 30, 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 the financial obligation associated
with
16
all Medicaid rebates and government chargebacks on our sales of these products through October
17, 2005. We are responsible for the financial obligation associated with 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. We had total sales-related reserves related to the financial
obligations associated with these products of $169,000 and $478,000 as of September 30, 2006 and
December 31, 2005, respectively that are included in Sales-Related Reserves in the accompanying
Consolidated Balance Sheets.
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 September 30, 2006, our intangible assets related to Doral purchased technology and
goodwill generated from a 1999 merger with RiboGene, Inc. The determination of the expected useful
lives of purchased technology and whether or not our intangible assets are impaired involves
significant judgment. Changes in strategy or market conditions could significantly impact these
judgments and require adjustments to recorded asset balances. In accordance with SFAS No. 144,
Accounting for the Impairment or Disposal of Long-Lived Assets, we review intangible assets, as
well as other long-lived assets, for impairment whenever events or circumstances indicate that the
carrying amount may not be fully recoverable. 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 the intangible assets. If the fair value is
greater than the carrying amount, then no impairment is indicated. As of September 30, 2006, 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. 123(R), using the modified-prospective transition method. Under the fair
value recognition provisions of SFAS 123(R), share-based compensation cost is estimated at the
grant date based on the fair value of the award and is recognized as expense, net of estimated
pre-vesting forfeitures, ratably over the vesting period of the award. Calculating share-based
compensation expense requires the input of highly subjective assumptions, including the expected
term of the share-based awards, stock price volatility, and pre-vesting forfeitures. We estimated
the expected life of stock options granted for the three and nine month periods ended September 30,
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 pre-vesting forfeiture rate and only recognize expense for those
shares expected to vest. We estimate the pre-vesting forfeiture rate based on historical
experience. If our actual forfeiture rate is materially different from our estimate, our
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 three and nine month periods ended September 30, 2006
includes $371,000 and $720,000, respectively, of share-based compensation expense related to
employees and non-employee members of our board of directors. As of September 30, 2006, $2.0
million of total unrecognized compensation cost related to unvested grants of stock options and
awards of restricted stock is expected to be recognized over a weighted-average period of 2.9
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 three and nine
month periods ended September 30, 2005 have not been restated.
Results of Operations
17
Three months ended September 30, 2006 compared to the three months ended September 30, 2005:
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Net product sales |
|
$ |
4,045 |
|
|
$ |
3,558 |
|
|
$ |
487 |
|
|
|
14 |
% |
Total net product sales for the three month period ended September 30, 2006 increased
$487,000, or 14%, from the three month period ended September 30, 2005. Total net product sales for
the three month period ended September 30, 2005 included $1.6 million in net product sales of
Nascobal, Ethamolin and Glofil-125. We sold our non-core product lines Nascobal, Ethamolin and
Glofil-125 in October 2005. Neurology net product sales for the three month period ended September
30, 2006, which consisted of Acthar and Doral net product sales, increased $2.1 million, or 107%,
as compared to neurology net product sales in the same period of 2005, which were comprised of
Acthar net product sales only. The increase in neurology net product sales was due primarily to a
94% increase in Acthar net product sales as compared to the three month period ended September 30,
2005. The increase in Acthar net product sales was due primarily to higher unit sales and an
approximate 8% increase in the average Acthar selling price as compared to the same period in 2005.
The increase in unit sales contributed approximately 85% of the increase in Acthar gross product
sales and the increase in the average selling price contributed approximately 15% of the increase
in Acthar gross product sales in the three month period ended September 30, 2006 as compared to the
same period in 2005. Net product sales of Doral of $256,000 also contributed to the increase in
neurology net product sales in the three month period ended September 30, 2006.
As described further in Note 13 of the accompanying Notes to Consolidated Financial
Statements, in May 2006 we purchased the rights in the United States to Doral from MedPointe. Doral
is a commercial product indicated for the treatment of insomnia, which occurs frequently in
patients with CNS diseases and disorders. MedPointes sales of Doral, before product returns,
rebates and chargebacks, 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. We commenced shipments of Doral in May 2006 and our sales force began actively
promoting Doral to neurologists in July 2006.
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, and the impact of our sales-related reserves.
Cost of Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September |
|
30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Cost of product sales |
|
$ |
945 |
|
|
$ |
522 |
|
|
$ |
423 |
|
|
|
81 |
% |
Cost of product sales for the three month period ended September 30, 2006 increased $423,000,
or 81%, to $945,000 from $522,000 for the three month period ended September 30, 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 increase was due primarily to an
increase of $473,000 in material and other direct costs for Acthar and an increase of $123,000 in
stability testing in the three month period ended September 30, 2006 as compared to the same period
in 2005. The increase in material and other direct costs was due primarily to higher Acthar unit
sales and an increase in the per unit material cost of Acthar. The increase in stability testing
was due to an increase in the number of stability tests on samples of manufactured Acthar batches
in the three month period ended September 30, 2006 as compared to the three month period ended
September 30, 2005. The increase in cost of product sales was partially offset by $223,000 of
material, shipping and other costs incurred during the three month period ended September 30, 2005
related to our non-core product lines which we sold in October 2005. Cost of product sales as a
percentage of total net product sales was 23.4% for the three month period ended September
18
30, 2006, as compared to 14.7% for the three month period ended September 30, 2005. The
increase in cost of product sales as a percentage of total net product sales in the three month
period ended September 30, 2006 as compared to the same period in 2005 was due primarily to
increased Acthar stability testing and distribution expense as a percentage of total net product
sales in the three month period ended September 30, 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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Selling, general and administrative expense |
|
$ |
4,171 |
|
|
$ |
2,298 |
|
|
$ |
1,873 |
|
|
|
82 |
% |
Selling, general and administrative expenses for the three month period ended September 30,
2006 increased $1.9 million from the three month period ended September 30, 2005. The increase was
due primarily to the expansion of our sales organization, increased promotion of Acthar and Doral,
and our adoption of SFAS No. 123(R). During the fourth quarter of 2005 and the first quarter of
2006, we expanded our sales organization from 15 to 40 field-based sales representatives and sales
management. In addition, 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. Doral is a commercial product indicated for the treatment of
insomnia, which occurs frequently in patients with CNS diseases and disorders. In July 2006 we
began promoting Doral to our targeted physicians. As a result, our selling and marketing expenses
increased substantially in the three month period ended September 30, 2006 as compared to the same
period in 2005. Sales and marketing headcount-related costs, excluding share-based compensation,
increased by approximately $890,000 and marketing and promotional expenses increased by
approximately $300,000 in the three month period ended September 30, 2006 as compared to the same
period in 2005. In September and October 2006 we added four additional sales representatives to our
sales organization.
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. 123(R). We incurred a non-cash charge of $371,000 for the three month
period ended September 30, 2006 resulting from the adoption of SFAS No. 123(R) of which $348,000
was included in selling, general and administrative expenses.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Research and development |
|
$ |
544 |
|
|
$ |
536 |
|
|
$ |
8 |
|
|
|
2 |
% |
Research and development expenses for the three month period ended September 30, 2006 were
$544,000, which approximated research and development expenses for the three month period ended
September 30, 2005. The costs included in research and development relate primarily to our medical
and regulatory affairs compliance activities and our preliminary evaluation of certain development
opportunities. An increase in fees for outside services of approximately $270,000 in the three
month period ended September 30, 2006 as compared to the same period in 2005 was partially offset
by decreases in regulatory fees resulting from the sale of our non-core product lines in the fourth
quarter of 2005 and patent-related legal fees.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
(Decrease) |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Depreciation and amortization |
|
$ |
94 |
|
|
$ |
319 |
|
|
$ |
(225 |
) |
|
|
(71 |
)% |
19
Depreciation and amortization expense for the three month period ended September 30, 2006
decreased to $94,000 from $319,000 for the three month period ended September 30, 2005. The
decrease was due primarily to the inclusion in the three month period ended September 30, 2005 of
amortization expense related to Nascobal purchased technology, partially offset by amortization
expense related to Doral 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.
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 was recorded to purchased technology and is being amortized on a
straight-line basis over fifteen years, the expected life of the Doral product rights.
Other Income and Expense Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
September 30, |
|
Increase/ |
|
|
2006 |
|
2005 |
|
(Decrease) |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Interest income |
|
$ |
137 |
|
|
$ |
29 |
|
|
$ |
108 |
|
Interest expense |
|
|
|
|
|
|
(38 |
) |
|
|
(38 |
) |
Other income, net |
|
|
51 |
|
|
|
5 |
|
|
|
46 |
|
Rental income, net |
|
|
|
|
|
|
67 |
|
|
|
(67 |
) |
Interest income for the three month period ended September 30, 2006 increased by $108,000 from
the three month period ended September 30, 2005 due to higher cash balances. Interest expense for
the three month period ended September 30, 2006 decreased by $38,000 from the three month period
ended September 30, 2005. The decrease was due primarily 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. Other income, net for the three month period ended September 30,
2006 increased by $46,000 from the three month period ended September 30, 2005 and was comprised of
changes to sales-related reserves associated with our divested product lines.
For the three month period ended September 30, 2006 we did not record net rental income as
compared to $67,000 of net rental income recognized for the three month period ended September 30,
2005. Net rental income for the three month period ended September 30, 2005 arose primarily from
the excess of income generated from the sublease of our former headquarters facility in Hayward,
California over the rent expense we incur on the Hayward facility. Our tenant vacated the Hayward
facility on July 31, 2006 and we are in the process of searching for a new tenant. As of September
30, 2006 we are obligated to pay rent on this facility of $5.3 million and our share of insurance,
taxes and common area maintenance through the expiration of our master lease in 2012. During the
fourth quarter of 2005 we determined that we may not be able to fully recover our costs related to
the Hayward facility over the period from January 1, 2006 through the expiration of our master
lease. We incurred $65,000 of expense associated with the Hayward facility for the three month
period ended September 30, 2006 that is included in selling, general, and administrative expense in
the accompanying Consolidated Statements of Operations.
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
three month period ended September 30, 2006. Dividends on Series B Preferred Stock of $168,000 for
the three month period ended September 30, 2005 represented the 8% dividend that was paid quarterly
to our Series B preferred stockholders. The dividend for the three month period ended September 30,
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.
20
Nine months ended September 30, 2006 compared to the nine months ended September 30, 2005:
Total Net Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
(Decrease) |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Net product sales |
|
$ |
9,384 |
|
|
$ |
12,346 |
|
|
$ |
(2,962 |
) |
|
|
(24 |
)% |
Total net product sales for the nine month period ended September 30, 2006 decreased $3.0
million, or 24%, from the nine month period ended September 30, 2005. Total net product sales for
the nine month period ended September 30, 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 and in January 2005 our agreement to promote VSL#3 terminated. Net
product sales in the nine month period ended September 30, 2005 included $5.4 million in net
product sales of the divested products and VSL#3. Neurology net product sales, which were comprised
of Acthar and Doral net product sales in the nine month period ended September 30, 2006, increased
35% to $9.4 million as compared to neurology net product sales of $7.0 million in the same period
in 2005, which consisted of Acthar net product sales only. The increase in neurology net product
sales was due primarily to an increase in unit sales of Acthar and an approximate 11% increase in
the average selling price of Acthar as compared to the same period in 2005. The increase in unit
sales contributed approximately 57% of the increase in Acthar gross product sales and the increase
in the average selling price of Acthar contributed approximately 43% of the increase in Acthar
gross product sales in the nine months ended September 30, 2006 as compared to the same period in
2005. Net product sales of Doral of $372,000 also contributed to the increase in neurology net
product sales in the nine month period ended September 30, 2006 as compared to the same period in
2005.
Cost of Product Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
(Decrease) |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Cost of product sales |
|
$ |
2,223 |
|
|
$ |
2,297 |
|
|
$ |
(74 |
) |
|
|
(3 |
)% |
Cost of product sales for the nine month period ended September 30, 2006 decreased $74,000, or
3%, to $2.2 million from $2.3 million for the nine month period ended September 30, 2005. The
decrease in cost of product sales is due primarily to the inclusion in the nine month period ended
September 30, 2005 of material, shipping and other costs of $785,000 related to our non-core
product lines which we sold in October 2005 and $49,000 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 $686,000 increase in material and other costs for Acthar
in the nine month period ended September 30, 2006 as compared to the same period in 2005. The
increase was due primarily to higher Acthar unit sales and to an increase in the per unit material
cost of Acthar in the nine month period ended September 30, 2006 as compared to the nine month
period ended September 30, 2005. Cost of product sales as a percentage of total net product sales
was 23.7% for the nine month period ended September 30, 2006, as compared to 18.6% for the nine
month period ended September 30, 2005. The increase in cost of product sales as a percentage of
total net product sales in the nine month period ended September 30, 2006 as compared to the same
period in 2005 was due primarily to increases in Acthar stability testing costs and distribution
expense as a percentage of total net product sales during the nine month period ended September 30,
2006.
21
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Selling, general and administrative expense |
|
$ |
12,582 |
|
|
$ |
7,140 |
|
|
$ |
5,442 |
|
|
|
76 |
% |
Selling, general and administrative expenses for the nine month period ended September 30,
2006 increased $5.4 million from the nine month period ended September 30, 2005, due primarily to
the expansion of our sales organization from 15 to 40 field-based
sales representatives and sales management during the fourth quarter of 2005 and the first quarter of
2006, increased promotion of Acthar and Doral, the adoption of SFAS No.123(R) and expense
associated with our Hayward facility. Sales and marketing costs, excluding share-based
compensation, increased by approximately $4.3 million in the nine month period ended September 30,
2006 as compared to the same period in 2005. We incurred a non-cash charge of $720,000 for the nine
month period ended September 30, 2006 resulting from the adoption of SFAS No. 123(R) of which
$676,000 was included in selling, general and administrative expenses. In addition, we incurred
expense of $382,000 for the nine month period ended September 30, 2006 related to our former
headquarters facility in Hayward, California.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Research and development |
|
$ |
1,632 |
|
|
$ |
1,597 |
|
|
$ |
35 |
|
|
|
2 |
% |
Research and development expenses of $1.6 million for the nine month period ended
September 30, 2006, were comparable to research and development expenses in the same period of 2005. The costs included in research and development relate primarily to our medical and regulatory
affairs compliance activities, our preliminary evaluation of certain development opportunities, and
expenses associated with our filing of our supplemental new drug application for Acthar for the
treatment of infantile spasms. In August 2006, the supplemental new drug application was accepted
for review by the FDA. We expect the FDA to take action on the supplemental new drug application
in the second quarter of 2007. In the
nine month period ended September 30, 2006, an increase in fees for outside services of
approximately $750,000 was partially offset by a decrease in regulatory fees of approximately
$430,000 resulting from the sale of our non-core product lines in the fourth quarter of 2005 and a
decrease in patent-related legal fees of approximately $150,000.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
% |
|
|
2006 |
|
2005 |
|
(Decrease) |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Depreciation and amortization |
|
$ |
218 |
|
|
$ |
953 |
|
|
$ |
(735 |
) |
|
|
(77 |
)% |
Depreciation and amortization expense for the nine month period ended September 30, 2006
decreased to $218,000 from $953,000 for the nine month period ended September 30, 2005. The
decrease was due primarily to the inclusion in the first nine months 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. The decrease was
partially offset by amortization expense related to Doral purchased technology, the rights to which
we acquired in May 2006.
22
Other Income and Expense Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
|
September 30, |
|
Increase/ |
|
|
2006 |
|
2005 |
|
(Decrease) |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Non-cash amortization of deemed discount on convertible debentures |
|
$ |
|
|
|
$ |
(108 |
) |
|
$ |
(108 |
) |
Interest income |
|
|
469 |
|
|
|
87 |
|
|
|
382 |
|
Interest expense |
|
|
|
|
|
|
(247 |
) |
|
|
(247 |
) |
Other income, net |
|
|
51 |
|
|
|
6 |
|
|
|
45 |
|
Rental income (expense), net |
|
|
(22 |
) |
|
|
181 |
|
|
|
(203 |
) |
We did not record any non-cash amortization of deemed discount on convertible debentures for
the nine month period ended September 30, 2006 as compared to $108,000 for the nine month period
ended September 30, 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 nine month period ended September 30, 2006 increased by $382,000 from
the nine month period ended September 30, 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
nine month period ended September 30, 2006 decreased by $247,000 from the nine month period ended
September 30, 2005. The decrease was due to the pay off during 2005 of the $2.2 million promissory
note we issued to Defiante in July 2004, and the redemption of our convertible debentures in April
2005. Other income, net for the nine month period ended September 30, 2006 increased by $45,000
from the nine month period ended September 30, 2005 and was comprised of changes to sales-related
reserves associated with our divested product lines.
For the nine month period ended September 30, 2006 we recorded $22,000 of rental expense as
compared to $181,000 of net rental income for the nine month period ended September 30, 2005. Net
rental income for the nine month period ended September 30, 2005 arose primarily from the excess of
income generated from the sublease of our former headquarters facility in Hayward, California over
the rent expense we incur on the Hayward facility. During the fourth quarter of 2005 we determined
that we may not be able to fully recover our costs related to the Hayward facility over the period
from January 1, 2006 through the expiration of our master lease in 2012. We incurred $382,000 in
expense associated with the Hayward facility for the nine month period ended September 30, 2006
that is included in selling, general, and administrative expense in the accompanying Consolidated
Statements of Operations.
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
nine month period ended September 30, 2006. Dividends on Series B Preferred Stock of $504,000 for
the nine month period ended September 30, 2005 represented the 8% dividend that was paid quarterly
to our Series B preferred stockholders. The dividends for the nine month period ended September 30,
2005 were paid in common stock.
The non-cash deemed dividend of $84,000 for the nine month period ended September 30, 2005 is
related to the revaluation of the warrants issued to the holders of our Series B Preferred Stock,
which resulted in an incremental value of $84,000 that decreased the carrying value of the
preferred stock. In connection with the revaluation, we 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. For the nine month period ended
September 30, 2005, the deemed dividend increased the net loss applicable to common shareholders in
the calculation of basic and diluted net loss per common share.
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.
23
At September 30, 2006, we had cash, cash equivalents and short-term investments of $9.3
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 totaling $7.8 million in
January 2006, the up-front payment related to our acquisition of the Doral product rights totaling
$2.5 million in May 2006 and cash used to fund operations. At September 30, 2006, our working
capital was $9.0 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, 1,647,440 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 $933,000 for the nine month period ended
September 30, 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
24
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 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 are promoting Doral to neurologists with our existing sales organization. The purchase price
allocated to the Doral product rights was recorded to purchased technology and is being amortized
on a straight-line basis over fifteen years, the expected life of the Doral product rights.
MedPointes sales of Doral, before product returns, rebates and chargebacks, for the year ended
December 31, 2005 totaled $1.1 million.
On June 9, 2006, we filed a shelf registration statement on Form S-3 with the Securities and
Exchange Commission, which was declared effective by the SEC on October 5, 2006. The shelf
registration statement will enable us to offer and sell up to $25 million of common shares or debt
securities from time to time in one or more offerings. The terms of any such future offering would
be established at the time of such offering.
Based on our internal forecasts and projections, we believe that our cash resources at
September 30, 2006 will be sufficient to fund our operations through at least September 30, 2007,
unless a substantial portion of our existing cash is used to acquire, license, develop, and
co-promote products for CNS disorders or our revenues are significantly less than we expect. Our
future funding requirements will depend on many factors, including: the implementation of our
business strategy; the timing and extent of product sales; the acquisition and licensing of
products, technologies or compounds, if any; our ability to manage growth; competing technological
and market developments; costs involved in filing, prosecuting, defending and enforcing patent and
intellectual property claims; the receipt of licensing or milestone fees from current or future
collaborative and license agreements, if established; the timing of regulatory approvals; any
expansion or acceleration of our development programs; and other factors. If our cash resources and
our revenues are not sufficient to meet our obligations, or if we have insufficient funds to
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.
Recently Issued Accounting Standards
In June 2006, the Financial Accounting Standards Board (FASB) issued Interpretation No. 48,
Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement No. 109 (FIN
48). This Interpretation clarifies the accounting for uncertainty in income taxes recognized in a
companys financial statements in accordance with FASB Statement No. 109, Accounting for Income
Taxes. FIN 48 requires that a company determine whether it is more likely than not that a tax
position will be sustained upon examination by the appropriate taxing authority. If a tax position
meets the more-likely-than-not recognition criteria, FIN 48 requires the tax position be measured
at the largest amount of benefit that is greater than 50 percent likely of being realized upon
ultimate settlement. FIN 48 is effective for fiscal years beginning after December 15, 2006. We do
not believe that the adoption of FIN 48 will have a material impact on our results of operations or
financial position.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (FAS 157). FAS 157
defines fair value, establishes a market-based framework or hierarchy for measuring fair value, and
expands disclosures about fair value measurements. FAS 157 is applicable whenever another
accounting pronouncement requires or permits assets and liabilities to be measured at fair value.
FAS 157 does not expand or require any new fair value measures. The provisions of SFAS No. 157 are
to be applied prospectively and are effective for financial statements issued for fiscal years
beginning after November 15, 2007. We are currently evaluating what effect, if any, the adoption of
SFAS No. 157 will have on our consolidated results of operations and financial position.
25
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at September 30, 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. Our disclosure controls and procedures were designed to provide reasonable
assurance that the controls and procedures would meet their objectives.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level.
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Not applicable
ITEM 1A. RISK FACTORS
Our exposure to the risks discussed in our Annual Report on Form 10-K for the year ended
December 31, 2005, in the section entitled Risk Factors, has not changed materially at September
30, 2006.
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
26
ITEM 6. EXHIBITS
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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. |
27
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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QUESTCOR PHARMACEUTICALS, INC.
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Date: November 14, 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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28
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. |
|
|
|
* |
|
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) |
|
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) |
|
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:
November 14, 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:
|
a) |
|
designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made
known to us by others within those entities, particularly during the period in which
this report is being prepared; |
|
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b) |
|
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):
|
a) |
|
all significant deficiencies and material weaknesses in the design or operation
of internal control over financial reporting which are reasonably likely to adversely
affect the registrants ability to record, process, summarize and report financial
information; and |
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b) |
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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:
November 14, 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
November 14, 2006, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q
for the quarter ended September 30, 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 September 30, 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: November 14, 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 September 30, 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: November 14, 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.