e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934. |
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2005
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934. |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
(State or other jurisdiction
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33-0476164
(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 Registrant is an accelerated filer (as defined in Rule 12B-2 of
the Act). Yes o No þ
At
August 8, 2005 there were 52,793,123 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.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
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June 30 |
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December 31, |
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2005 |
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2004 |
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(Unaudited) |
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(Note 1) |
ASSETS |
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Current assets: |
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Cash and cash equivalents |
|
$ |
4,429 |
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$ |
8,729 |
|
Accounts receivable, net of allowances for doubtful accounts of $125 and $40 at
June 30, 2005 and December 31, 2004, respectively |
|
|
2,561 |
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|
2,349 |
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Inventories |
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1,900 |
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|
1,769 |
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Prepaid expenses and other current assets |
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|
907 |
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|
839 |
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|
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|
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|
|
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Total current assets |
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9,797 |
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|
13,686 |
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Property and equipment, net |
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|
520 |
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|
614 |
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Purchased technology, net |
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14,231 |
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|
12,758 |
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Goodwill |
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|
299 |
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|
299 |
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Deposits and other assets |
|
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728 |
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|
816 |
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Total assets |
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$ |
25,575 |
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$ |
28,173 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,038 |
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$ |
1,103 |
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Accrued compensation |
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|
727 |
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|
974 |
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Sales-related reserves |
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2,589 |
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|
1,683 |
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Other accrued liabilities |
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614 |
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598 |
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Short-term debt and current portion of long-term debt and capital lease obligation |
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619 |
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349 |
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Convertible debentures (face amount of $4,000), net of deemed discount of $103 at
December 31, 2004 |
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3,897 |
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Total current liabilities |
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5,587 |
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8,604 |
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Long-term debt and long-term portion of capital lease obligation |
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1,683 |
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2,021 |
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Other non-current liabilities |
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884 |
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886 |
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Preferred stock, no par value, 7,500,000 shares authorized; 2,155,715 Series A
shares issued and outstanding at June 30, 2005 and December 31, 2004 (aggregate
liquidation preference of $10,000 at June 30, 2005 and December 31, 2004) |
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5,081 |
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5,081 |
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Shareholders equity: |
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Preferred stock, no par value, 8,400 Series B shares issued and outstanding at
June 30, 2005 and December 31, 2004, net of issuance costs (aggregate liquidation
preference of $8,400 at June 30, 2005 and December 31, 2004) |
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7,578 |
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7,578 |
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Common stock, no par value, 105,000,000 shares authorized; 52,759,547 and
51,216,488 shares issued and outstanding at June 30, 2005 and December 31, 2004,
respectively |
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89,280 |
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88,436 |
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Deferred compensation |
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(7 |
) |
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(10 |
) |
Accumulated deficit |
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(84,511 |
) |
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(84,423 |
) |
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Total shareholders equity |
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12,340 |
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11,581 |
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Total liabilities and shareholders equity |
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$ |
25,575 |
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$ |
28,173 |
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See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2005 |
|
2004 |
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2005 |
|
2004 |
Revenues: |
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Net product sales |
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$ |
4,290 |
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$ |
4,090 |
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$ |
8,788 |
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$ |
9,238 |
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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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1,027 |
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|
961 |
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1,775 |
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1,817 |
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Selling, general and administrative |
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2,224 |
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2,515 |
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4,842 |
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5,543 |
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Research and development |
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562 |
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421 |
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1,061 |
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|
999 |
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Depreciation and amortization |
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323 |
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|
301 |
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|
634 |
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|
599 |
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Total operating costs and expenses |
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4,136 |
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|
4,198 |
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8,312 |
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8,958 |
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Income (loss) from operations |
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154 |
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(108 |
) |
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476 |
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|
280 |
|
Non-cash amortization of deemed discount on convertible debentures |
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(131 |
) |
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|
(108 |
) |
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|
(262 |
) |
Interest income |
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23 |
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|
13 |
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|
58 |
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24 |
|
Interest expense |
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(70 |
) |
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|
(81 |
) |
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(209 |
) |
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(164 |
) |
Other income, net |
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1 |
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1 |
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3 |
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Rental income, net |
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71 |
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|
60 |
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|
114 |
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|
142 |
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Net income (loss) |
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|
179 |
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|
(247 |
) |
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|
332 |
|
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|
23 |
|
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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168 |
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336 |
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340 |
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Net income (loss) applicable to common shareholders |
|
$ |
11 |
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|
$ |
(415 |
) |
|
$ |
(88 |
) |
|
$ |
(317 |
) |
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|
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Basic and diluted net income (loss) per share applicable to common
shareholders |
|
$ |
0.00 |
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|
$ |
(0.01 |
) |
|
$ |
0.00 |
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|
$ |
(0.01 |
) |
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Shares used in computing basic and diluted net income (loss) per share
applicable to common shareholders |
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52,660 |
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51,060 |
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51,942 |
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50,546 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Six Months Ended |
|
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June 30, |
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2005 |
|
2004 |
OPERATING ACTIVITIES |
|
|
|
|
|
|
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Net income |
|
$ |
332 |
|
|
$ |
23 |
|
Adjustments to reconcile net income to net cash provided by operating activities: |
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Stock-based compensation expense |
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1 |
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17 |
|
Amortization of deemed discount on convertible debentures |
|
|
108 |
|
|
|
262 |
|
Amortization of deferred compensation |
|
|
3 |
|
|
|
4 |
|
Depreciation and amortization |
|
|
634 |
|
|
|
599 |
|
Deferred rent expense |
|
|
(2 |
) |
|
|
17 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(212 |
) |
|
|
(17 |
) |
Inventories |
|
|
(131 |
) |
|
|
60 |
|
Prepaid expenses and other current assets |
|
|
268 |
|
|
|
299 |
|
Accounts payable |
|
|
(65 |
) |
|
|
(356 |
) |
Accrued compensation |
|
|
(247 |
) |
|
|
(111 |
) |
Sales-related reserves |
|
|
906 |
|
|
|
137 |
|
Other accrued liabilities |
|
|
16 |
|
|
|
(59 |
) |
|
|
|
|
|
|
|
|
|
Net cash flows provided by operating activities |
|
|
1,611 |
|
|
|
875 |
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INVESTING ACTIVITIES |
|
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Purchase of property and equipment |
|
|
(14 |
) |
|
|
(195 |
) |
Acquisition of purchased technology |
|
|
(2,000 |
) |
|
|
|
|
Proceeds from sale of property and equipment |
|
|
1 |
|
|
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|
(Increase) decrease in other assets |
|
|
83 |
|
|
|
(11 |
) |
|
|
|
|
|
|
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Net cash flows used in investing activities |
|
|
(1,930 |
) |
|
|
(206 |
) |
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FINANCING ACTIVITIES |
|
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Issuance of common stock, net of issuance costs |
|
|
87 |
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|
2,430 |
|
Short-term borrowings |
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|
191 |
|
|
|
211 |
|
Repayment of short-term and long-term debt |
|
|
(259 |
) |
|
|
(295 |
) |
Redemption of convertible debentures |
|
|
(4,000 |
) |
|
|
|
|
Payment of Series B preferred stock dividends |
|
|
|
|
|
|
(336 |
) |
|
|
|
|
|
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Net cash flows provided by (used in) financing activities |
|
|
(3,981 |
) |
|
|
2,010 |
|
|
|
|
|
|
|
|
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|
Increase (decrease) in cash and cash equivalents |
|
|
(4,300 |
) |
|
|
2,679 |
|
Cash and cash equivalents at beginning of period |
|
|
8,729 |
|
|
|
3,220 |
|
|
|
|
|
|
|
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|
Cash and cash equivalents at end of period |
|
$ |
4,429 |
|
|
$ |
5,899 |
|
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|
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SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|
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|
|
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Cash paid for interest |
|
$ |
209 |
|
|
$ |
164 |
|
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|
|
|
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NON-CASH INVESTING AND FINANCING ACTIVITIES: |
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|
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Deemed dividend related to beneficial conversion feature of Series B preferred stock |
|
$ |
84 |
|
|
$ |
|
|
|
|
|
|
|
|
|
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|
Common stock issued in lieu of quarterly cash dividends on Series B preferred stock |
|
$ |
672 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Common stock issued upon conversion of Series B preferred stock and accrued
dividends for Series B preferred stock |
|
$ |
|
|
|
$ |
704 |
|
|
|
|
|
|
|
|
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|
See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED JUNE 30, 2005 FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Questcor Pharmaceuticals, Inc. (the Company) is a specialty pharmaceutical company that
focuses on developing and commercializing novel therapeutics for the treatment of neurological
disorders. The Company focuses on the treatment of diseases and disorders of the central nervous
system (CNS), which are served by a limited group of physicians such as neurologists. The
Companys strategy is to acquire pharmaceutical 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 at a reasonable
valuation relative to the Companys cost of capital. In addition, through corporate collaborations,
the Company intends to develop new medications focused on its target markets. The Company currently
markets four products in the United States: H.P. Acthar® Gel (Acthar), 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 commonly used in treating
patients with infantile spasm; Nascobal®, the only prescription nasal gel used for the treatment of
various Vitamin B-12 deficiencies; Ethamolin®, an injectable drug used to treat enlarged weakened
blood vessels at the entrance to the stomach that have recently bled, known as esophageal varices;
and Glofil®-125, an injectable agent that assesses how well the kidney is working by measuring
glomerular filtration rate, or kidney function. The Companys agreement to promote and sell VSL#3®,
a patented probiotic marketed as a dietary supplement to promote normal gastrointestinal function,
expired in January 2005.
The accompanying unaudited consolidated financial statements of the Company have been prepared
in accordance with accounting principles generally accepted in the United States and applicable
Securities and Exchange Commission regulations for interim financial information. These financial
statements do not include all of the information and footnotes required by accounting principles
generally accepted in the United States for complete financial statements. The unaudited financial
statements should be read in conjunction with the audited financial statements and related
footnotes included in the Companys Annual Report on Form 10-K for the year ended December 31,
2004, as filed on March 31, 2005 with the Securities and Exchange Commission. The accompanying
balance sheet at December 31, 2004 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 periods presented are not necessarily indicative
of the results that may be expected for the year ending December 31, 2005. The consolidated
financial statements include the accounts of the Company and its wholly owned subsidiaries. All
significant intercompany accounts and transactions have been eliminated.
2. STOCK-BASED COMPENSATION
The Company generally grants stock options to its employees for a fixed number of shares with
an exercise price equal to the fair market value of the shares on the date of grant. As allowed
under Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based
Compensation (SFAS No. 123), the Company has elected to follow Accounting Principles Board
Opinion No. 25, Accounting for Stock Issued to Employees and related interpretations in
accounting for stock awards to employees. Accordingly, no compensation expense is recognized in the
Companys financial statements in connection with stock options granted to employees with exercise
prices not less than fair market value. Deferred compensation for options granted to employees is
determined as the difference between the fair market value of the Companys common stock on the
date options were granted and the exercise price. For purposes of disclosures pursuant to SFAS No.
123, as amended by Statement of Financial Accounting Standards No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure, the estimated fair value of options is amortized to
expense over the options vesting periods.
6
The following table illustrates the effect on net income (loss) per share applicable to common
shareholders if the Company had applied the fair value recognition provisions of SFAS No. 123 to
stock-based employee compensation (in thousands, except per share amounts):
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2005 |
|
2004 |
|
2005 |
|
2004 |
Net income (loss) applicable to common shareholders as reported |
|
$ |
11 |
|
|
$ |
(415 |
) |
|
$ |
(88 |
) |
|
$ |
(317 |
) |
Add: Stock-based employee compensation expense included in
reported net income (loss) |
|
|
1 |
|
|
|
2 |
|
|
|
2 |
|
|
|
7 |
|
Deduct: Total stock-based employee compensation expense
determined under fair value method for all awards |
|
|
(107 |
) |
|
|
(198 |
) |
|
|
(228 |
) |
|
|
(342 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss applicable to common shareholders, pro forma |
|
$ |
(95 |
) |
|
$ |
(611 |
) |
|
$ |
(314 |
) |
|
$ |
(652 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net income (loss) per share applicable to common
shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As reported |
|
$ |
0.00 |
|
|
$ |
(0.01 |
) |
|
$ |
0.00 |
|
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
$ |
0.00 |
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compensation expense for options granted to non-employees has been determined in accordance
with SFAS No. 123 and EITF 96-18, Accounting for Equity Instruments that are Issued to Other than
Employees for Acquiring, or in conjunction with Selling Goods or Services, as the fair value of
the consideration received or the fair value of the equity instruments issued, whichever is more
reliably measured. Compensation expense for options granted to non-employees is periodically
re-measured as the underlying options vest.
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS No. 123R,
Share-Based Payment, a revision to SFAS No. 123, Accounting for Stock-Based Compensation. SFAS
No. 123R eliminates the Companys ability to use the intrinsic value method of accounting under APB
Opinion 25, Accounting for Stock Issued to Employees, and generally requires a public entity to
reflect on its income statement, instead of pro forma disclosures in its financial footnotes, the
cost of employee services received in exchange for an award of equity instruments based on the
grant-date fair value of the award. The grant-date fair value will be estimated using
option-pricing models adjusted for the unique characteristics of those equity instruments. SFAS No.
123R is effective generally for public companies as of the beginning of the first interim or annual
reporting period that begins after December 15, 2005. SFAS No. 123R applies to all awards granted
after the required effective date, to awards that are unvested as of the effective date, and to
awards modified, repurchased, or cancelled after that date. As of the required effective date, all
public entities that used the fair-value-based method for either recognition or disclosure under
the original SFAS No. 123 will apply this revised statement. Under SFAS No. 123R, the Company must
determine the appropriate fair value model to be used for valuing share-based payments, the
amortization method for compensation cost and the transition method to be used at date of adoption.
The transition methods include modified prospective and modified retrospective adoption options.
Under the modified prospective method, compensation cost is recognized beginning with the effective
date (a) based on the requirements of SFAS No. 123R for all share-based payments granted after the
effective date and (b) based on the requirements of SFAS No. 123 for all awards granted to
employees prior to the effective date of SFAS No. 123R that remain unvested on the effective date.
The modified retrospective method includes the requirements of the modified prospective method
described above, but also permits entities to restate based on the amounts previously recognized
under SFAS No. 123 for purposes of pro forma disclosures, either (a) all prior periods presented or
(b) prior interim periods of the year of adoption. The Company is currently evaluating the
requirements of SFAS No. 123R and will adopt this statement at the effective date. The Company
expects that the adoption of this statement may have a material effect on its financial statements.
3. REVENUE RECOGNITION
Revenues from product sales are recognized based upon shipping terms, net of estimated
reserves for government chargebacks, Medicaid rebates, payment discounts, and returns for credit.
Revenue is recognized upon customer receipt of the shipment, provided the 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 records estimated sales reserves against product revenues for government
chargebacks, Medicaid rebates, payment discounts and product returns for credit memoranda. The
Companys policy of issuing credit memoranda for expired product, which became effective for
product lots released after May 31, 2004, allows customers to return expired product for credit
within a six-month period after the expiration date. Customers who return expired product from
production lots released after May 31, 2004 will be
7
issued credit memoranda equal to the sales value of the product returned, and the estimated
amount of such credit memoranda is recorded as a liability with a corresponding reduction in gross
product sales. This reserve will be reduced as future credit memoranda are issued, with an offset
to accounts receivable.
The Companys product exchange policy, which applies to product lots released prior to June 1,
2004, allows customers to return expired product for exchange within a six-month period after the
expiration date. Returns from these product lots are exchanged for replacement product, and
estimated costs for such exchanges, which include actual product material costs and related
shipping charges, are included in Cost of Product Sales. Returns are subject to inspection prior to
acceptance. For Glofil and VSL#3 the Company accepts no returns for expired product.
The Company records estimated sales reserves for expected product exchanges and 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, product exchanges and product returns
for credit memoranda were $2,589,000 and $1,683,000 at June 30, 2005 and December 31, 2004,
respectively, and are classified as Sales-Related Reserves in the Consolidated Balance Sheets. The
reserves at June 30, 2005 include $1,885,000 for estimated product returns for credit memoranda on
product lots of Acthar and Nascobal released and shipped after May 31, 2004.
The Company sells product to wholesalers, who in turn sell these products to pharmacies and
hospitals. In the case of VSL#3, the Company sold directly to consumers. The Company does not
require collateral from its customers.
4. CASH AND CASH EQUIVALENTS
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 and cash equivalents of
$4,429,000 and $8,729,000 at June 30, 2005 and December 31, 2004, respectively. All cash
equivalents are in money market funds and commercial paper. The fair value of the funds
approximated cost.
5. INVENTORIES
Inventories are stated at the lower of cost (first-in, first-out method) or market and consist
of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2005 |
|
2004 |
Raw materials |
|
$ |
1,160 |
|
|
$ |
1,239 |
|
Work in process |
|
|
523 |
|
|
|
228 |
|
Finished goods |
|
|
297 |
|
|
|
409 |
|
Less allowance for excess and obsolete inventories |
|
|
(80 |
) |
|
|
(107 |
) |
|
|
|
|
|
|
|
|
|
|
|
$ |
1,900 |
|
|
$ |
1,769 |
|
|
|
|
|
|
|
|
|
|
6. PURCHASED TECHNOLOGY AND INTANGIBLE ASSETS
Goodwill no longer subject to amortization amounted to $299,000 at June 30, 2005 and December
31, 2004. The Company performed an impairment test of goodwill (including assembled workforce)
during the quarter ended December 31, 2004, which resulted in an impairment charge of $180,000
related to the assembled workforce. The Company will continue to monitor the carrying value of the
remaining goodwill through the annual impairment tests or more frequently if indicators of
potential impairment exist. As of June 30, 2005, no indicators of potential impairment existed.
Purchased technology at June 30, 2005 includes $14.2 million related to the Nascobal
acquisition and $2.0 million related to the transfer of the New Drug Application (NDA) for the
Nascobal nasal spray from Nastech Pharmaceutical Company Inc. (Nastech). The Nascobal purchased
technology is being amortized over its estimated life of 15 years. Accumulated amortization for the
Nascobal purchased technology is $1,993,000 as of June 30, 2005.
8
As part of the Nascobal acquisition, the Company acquired rights to Nascobal nasal spray, an
improved dosage form, for which an NDA was filed by Nastech with the Food and Drug Administration
(FDA) at the end of 2003. Under the terms of the Agreement, subject to the approval of the NDA
for the new Nascobal nasal spray dosage form by the FDA, the Company was required to make a $2.0
million payment for the transfer of the NDA from Nastech to the Company. In February 2005, the NDA
for Nascobal spray was approved by the FDA, and the Company paid the required $2.0 million to
Nastech.
7. CONVERTIBLE DEBENTURES
In March 2002, the Company issued $4.0 million of 8% convertible debentures to SF Capital
Partners Ltd. (SFCP), and Defiante Farmaceutica Lda (Defiante), a wholly-owned subsidiary of
Sigma-Tau Finanziaria SpA (Sigma-Tau), a significant shareholder and affiliate of the Company.
Sigma-Tau beneficially owned approximately 26% of the Companys outstanding common stock as of June
30, 2005. The Company 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 the Companys common stock at a
fixed conversion price of $1.58 per share (subject to adjustment for stock splits and
reclassifications).
On March 8, 2005, the Company and Defiante entered into an amendment to the Convertible
Debenture issued by the Company in favor of Defiante, extending the maturity date to April 15,
2005. On March 10, 2005, the Company and SFCP entered into an amendment to the Convertible
Debenture issued by the Company in favor of SFCP, extending the maturity date to April 15, 2005 and
amending certain of the terms of the Companys option to repay the SFCP Debenture in shares of
common stock at the maturity date.
On April 15, 2005, the Company redeemed both convertible debentures in full in cash totaling
$4.0 million, plus accrued interest to April 15, 2005.
8. SECURED PROMISSORY NOTE
In July 2004, the Company issued a $2.2 million secured promissory note to Defiante. The
interest rate on the note is 9.83% per annum. Repayment of the note consists of interest only for
the first twelve months, with monthly principal and interest payments thereafter through August
2008. The note is secured by the Nascobal intellectual property including the NDA for the spray
formulation. The Company purchased the world-wide rights to Nascobal, including the rights to the
spray formulation from Nastech in June 2003.
9. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
The Company, as permitted under California law and in accordance with its Bylaws, indemnifies
its officers and directors for certain events or occurrences while the officer or director is or
was serving at the Companys request in such capacity. The potential future indemnification limit
is to the fullest extent permissible under California law; however, the Company has a director and
officer insurance policy that limits its exposure and may enable it to recover a portion of any
future amounts paid. The Company believes the fair value of these indemnification agreements is
minimal. Accordingly, the Company has no liabilities recorded for these agreements as of June 30,
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.
10. 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 gives effect to all potentially dilutive common shares
outstanding during the period such as options, warrants, convertible preferred stock, and
contingently issuable shares. Diluted net income per share applicable to common shareholders has
not been presented separately for the quarter ended June 30, 2005 as basic net income per share is
$0.00. Diluted net loss per share applicable to common shareholders has not been presented
separately for the six months ended June 30, 2005 and the periods ending June 30, 2004 as, due to
the Companys net loss position, it is anti-dilutive. If the Companys net income per share
applicable to common shareholders had been $0.01 or greater for the quarter ended June 30 2005,
then shares used in calculating diluted earnings per share applicable to common shareholders would
have included, if dilutive, the
9
effect of the outstanding options to purchase 6,343,824 common shares, 11,080,492 convertible
preferred shares, placement unit options for 127,679 common shares and warrants to purchase
4,539,407 common shares.
11. EQUITY TRANSACTIONS
In April 2005, the Company issued 1,344,000 shares of common stock in a private placement to
holders of its Series B Preferred Stock. The shares were issued in lieu of the quarterly cash
dividends payable on April 1, 2005, July 1, 2005, October 1, 2005 and January 1, 2006, and had 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 (See Note 12 Series B Convertible Preferred Stock).
In July 2005, shares of the Companys Series B Preferred Stock with a stated value of $25,000,
less prepaid dividends of $1,400, were converted into 25,027 shares of common stock.
10
12. SERIES B CONVERTIBLE PREFERRED STOCK
In January 2003, the Company completed a private placement of Series B Convertible Preferred
Stock and warrants to purchase common stock to various investors. Gross proceeds to the Company
from the private placement were $10 million. Net of issuance costs, the proceeds to the Company
were $9.4 million. Of the original $10 million stated value, Series B Convertible Preferred Stock
having a stated value of $1.6 million has been converted into common stock, resulting in a stated
value of $8.4 million for Series B Convertible Preferred Stock as of June 30, 2005.
According to the terms of the private placement agreement, each holder of Series B Convertible
Preferred Stock is entitled to a quarterly dividend at an initial rate of 8% per year, which will
increase to 10% per year on and after January 1, 2006, and to 12% on and after January 1, 2008. The
dividends are paid in cash on a quarterly basis. In addition, on the occurrence of designated
events, including the failure to maintain Net Cash, Cash Equivalent and Eligible Investment
Balances, as defined in the Companys Certificate of Determination of Series B Preferred Stock (the
Certificate of Determination), of at least 50% of the aggregate stated value of the outstanding
shares of Series B Preferred Stock, the dividend rate will increase by an additional 6% per year.
The purchasers of the Series B Preferred Stock also received for no additional consideration
warrants exercisable for an aggregate of 3,399,911 shares of Common Stock at an exercise price of
$0.9412, as adjusted by agreement dated June 13, 2003, per share, subject to certain anti-dilution
adjustments. The expiration date of the warrants was January 15, 2007. In January 2004 warrants to
purchase 373,990 shares of common stock were surrendered as consideration, along with cash, for the
issuance of 373,990 shares of common stock.
In March 2005, the Company and all of the holders of the outstanding shares of Series B
Preferred Stock of the Company 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 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 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 six months ended June 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.
In July 2005, shares of the Companys Series B Preferred Stock with a stated value of $25,000,
less prepaid stock dividends of $1,400, were converted into 25,027 shares of common stock.
13. 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. 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 did not accept returns of VSL#3. There was no VSL#3 revenue for
the quarter ended June 30, 2005, as the agreement expired in January 2005, and minimal revenue for
the six month period ended June 30, 2005. An access fee to Sigma-Tau Pharmaceuticals was calculated
quarterly, which varied based upon sales and costs incurred by the Company subject to reimbursement
under certain circumstances and is included in selling, general and administrative expense in the
accompanying Condensed Consolidated Statements of Operations. The Company recorded a cost
reimbursement of $79,000 in the three months ended June 30, 2005, which reduced selling, general
and administrative expense. The Company recorded an expense of $119,000 related to the VSL#3 access
fee in the three months ended June 30, 2004. During the three months ended June 30, 2005 and 2004,
the Company paid $203,000 and $168,000, respectively, to
11
Sigma-Tau Pharmaceuticals for the purchase of VSL#3 product and access fees. Payment to
Sigma-Tau Pharmaceuticals in the second quarter of 2005 relates to activity under the promotion
agreement prior to its expiration. Included in Accounts Receivable is $82,000 for amounts owed by
Sigma-Tau Pharmaceuticals at June 30, 2005 as reimbursement of costs incurred by the Company prior
to the expiration of the promotion agreement.
Upon the hiring of Reinhard Koenig, MD, PhD as Vice President, Medical Affairs in February
2004, the Company loaned $50,000 to Dr. Koenig, at an interest rate of prime plus 1% per annum, in
exchange for a promissory note. The principal and interest was to be forgiven on February 8, 2005
provided that Dr. Koenig continued as a full-time employee through that date. In May 2004, Dr.
Koenig was appointed an officer of the Company. Dr. Koenig continued as a full-time employee
through the specified date, and the principal and interest were forgiven in February 2005 in
accordance with the terms of the note. For accounting purposes, the loan was amortized over the one
year service period.
14. COMPREHENSIVE INCOME (LOSS)
For the three and six month periods ended June 30, 2005 and 2004, net income (loss) was the same as
comprehensive income (loss).
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 fiscal year ended December 31, 2004, including Item 1 Business of Questcor,
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 developing and commercializing novel
therapeutics for the treatment of neurological disorders. We focus on the treatment of diseases and
disorders of the central nervous system (CNS), which are served by a limited group of physicians
such as neurologists. Our strategy is to acquire pharmaceutical products that we believe have sales
growth potential, are promotionally responsive to a focused and targeted sales and marketing
effort, complement our therapeutic focus on neurology and can be acquired at a reasonable valuation
relative to our cost of capital. We currently market four products in the United States:
|
|
|
H.P. Acthar® Gel (Acthar), 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 commonly used in treating patients
with infantile spasm; |
|
|
|
|
Nascobal®, the only prescription nasal gel used for the treatment of various Vitamin B-12
deficiencies including Vitamin B-12 deficiencies associated with Crohns disease, gastric
bypass surgery and MS; |
|
|
|
|
Ethamolin®, an injectable drug used to treat enlarged weakened blood vessels at the
entrance to the stomach that have recently bled, known as esophageal varices; and |
|
|
|
|
Glofil®-125, an injectable agent that assesses how well the kidney is working by
measuring glomerular filtration rate, or kidney function. |
In January 2005, our agreement to promote and sell VSL#3 expired in accordance with its terms.
Our strategy, which we announced in April 2005, is to focus on developing and commercializing
products that treat CNS diseases and disorders. As part of this strategy, we are initially focusing
our promotional efforts on Acthar, our neurological product. We also intend to pursue the licensing
and acquisition of products that are consistent with our focus on neurology. In addition, we intend
to develop new products that have the potential to address significant unmet medical needs in the
CNS field, using both our own
12
intellectual property and intellectual property licensed from other companies. We are
currently evaluating the divestiture of non-core assets to help fund these acquisition and
development efforts.
Consistent with our prior focus on sales and marketing, our spending on research and
development activities to date is modest. Expenses incurred for the Acthar manufacturing site
transfer and medical and regulatory affairs are classified as Research and Development Expenses in
the accompanying unaudited Condensed Consolidated Statements of Operations. We expect our research
and development spending to increase in the future as we implement our new strategy. We have
entered into agreements with pharmaceutical and biotechnology companies to further the development
of certain acquired technology. In June 2002, we signed a definitive License Agreement with
Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer), whereby we granted Fabre-Kramer exclusive
worldwide rights to develop and commercialize HypnostatTM (intranasal triazolam for the
treatment of insomnia) and PanistatTM (intranasal alprazolam for the treatment of panic
disorders). We have a development agreement with Rigel Pharmaceuticals, Inc. of South San
Francisco, California for our antiviral drug discovery program, and a development agreement with
Dainippon Pharmaceuticals Co., Ltd. of Osaka, Japan for our antibacterial program.
We have incurred an accumulated deficit of $84.5 million at June 30, 2005. At June 30, 2005,
we had $4.4 million in cash and cash equivalents. Results of operations may vary significantly from
quarter to quarter depending on, among other factors, the results of our sales efforts,
prescription demand for our products, inventory levels of our products at wholesalers, timing of
expiration of our products, shipment of replacement product under our product exchange policy,
future credit memoranda to be issued under our credit memoranda 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 corporate partnering
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
accounting principles generally accepted in the United States. The preparation of these financial
statements requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate our
estimates, including those related to sales reserves, product returns, bad debts, inventories and
intangible assets. 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 goods purchased by patients covered
by Medicaid, and cash discounts for prompt payment. We estimate our reserves by utilizing
historical information for existing products and data obtained from external sources. For new
products, we estimate our reserves for product returns, government chargebacks and rebates on
specific terms for product returns, chargebacks and rebates, and our experience with similar
products.
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 exchange or credit memoranda 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 have a product exchange policy, effective for product lots released prior to June 1, 2004,
in which we will ship replacement product for expired product returned to us within six months
after expiration. The estimated costs for such potential exchanges, which
13
include actual product costs and related shipping charges, are included in cost of product
sales. In estimating returns for each product, we analyze (i) historical returns and sales
patterns, (ii) current inventory on hand at wholesalers and the remaining shelf life of that
inventory (ranging from 18 months to 3 years for all products except Glofil, which is not subject
to our product return policy), and (iii) changes in demand measured by prescriptions or other data
as provided by an independent third party source and our internal estimates. We believe that the
information obtained from wholesalers regarding inventory levels and from independent third parties
regarding prescription demand is reliable, but we are unable to independently verify the accuracy
of such data. For Glofil, we accept no returns for expired product. We routinely assess our
historical experience including customers compliance with our product exchange policy, and we
adjust our reserves as appropriate.
During the second quarter of 2004 we implemented a transition plan for expired product returns
from the product exchange policy to a credit memoranda policy for the return of expired product
within six months after the expiration date. Expired product returned from lots released after May
31, 2004 is subject to a credit memoranda policy in which a credit memoranda will be issued for the
original purchase price of the returned product. A reserve for the sales value of estimated returns
on shipments of Acthar and Nascobal product lots released and shipped after May 31, 2004 has been
recorded as a liability in the amount of $1,885,000 as of June 30, 2005 with a corresponding
reduction in gross product sales. This reserve reflects an estimate of future credit memoranda to
be issued for Acthar and Nascobal, applied to the quantity of product shipped from lots subject to
the credit memoranda policy. The reserve will be reduced as future credit memoranda are issued,
with an offset to accounts receivable. Total sales-related reserves increased to $2,589,000 at June
30, 2005 from $1,683,000 at December 31, 2004. The increase in total sales-related reserves
includes an increase of $832,000 for reserves recorded under our credit memoranda policy in the
first six months of 2005.
In estimating the return rate for expired product subject to credit memoranda, we analyze (i)
historical returns and sales patterns, (ii) current inventory on hand at wholesalers and the
remaining shelf life of that inventory, and (iii) changes in demand measured by prescriptions and
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. A new lot of Ethamolin is not expected to be released until late 2005,
at which time a reserve for credit memoranda will be estimated and recorded as a reduction of gross
product sales based upon the quantity of product shipped. This will reduce the future amount
recorded as net product sales.
A transition period will extend through 2006 between the existing product exchange policy,
applicable to product lots released prior to June 1, 2004, and the new credit memoranda policy,
applicable to product lots released after May 31, 2004. Return periods (six months after
expiration) for product lots released prior to June 1, 2004 end as follows: Acthar, June 2005;
Nascobal, May 2006; Ethamolin, October 2006. The credit memoranda policy commenced with the actual
release of product lots of Acthar in June 2004 and Nascobal in July 2004, and will apply to the
actual release of an Ethamolin lot currently planned for late 2005. Planned releases of products
are subject to change. Reserves for the estimated credit memoranda applicable to future returns
related to sales from these product lots will be recorded as shipments occur, and will reduce gross
product sales. Until the transition from our product exchange policy to a credit memoranda policy
for expired product is complete in 2006, both the product exchange policy and the credit memoranda
policy will be in effect at the same time, which will result in lower revenues than historically
experienced due to the additional impact of displacement of future sales from the product exchange
policy and reduction of gross product sales for the reserves under the credit memoranda policy.
If we were to issue credit memoranda for all returns currently subject to the product exchange
policy, the reserves for credit memoranda would be significantly increased, with an offset to gross
product sales at the time of the policy change. The reserve would be based on an estimate of the
future credit memoranda to be issued based upon historical return rates by product, applied to the
quantity of product sold that has not yet expired. If such a policy change occurred, the negative
impact on our revenues, operations and cash position would be substantial in the near term.
Further, if such a policy change were made, the currently recorded reserve for product exchanges
would be eliminated resulting in a reduction of cost of product sales.
Certain customers have deducted the full price of expired product which they planned to return
from the amounts owed to us (returns receivable). We reached an agreement with our three largest
wholesalers to accept replacement product and pay the amounts previously deducted in return for an
administration fee, however it remains their standard practice to deduct from payments to us the
sales value of expired product that they have requested authorization to return. As of June 30,
2005, our returns receivable is $501,000, primarily due to return materials authorization requests
for expired product from the Acthar lot that expired in December 2004, the Nascobal lot that
expired in February 2005, and Ethamolin lots that expired in December 2004 and January and February
2005. Wholesalers have indicated that they will reimburse us for these deductions upon the
replacement of expired units in accordance with our product exchange policy; however, in our
experience the timing of such reimbursements is slower than the collection of our normal trade
receivables. As of June 30, 2005, replacement units have been shipped with respect to approximately
6% of the amounts
14
owing to us and we are seeking reimbursement from these wholesalers. As long as the
wholesalers standard practice is to deduct amounts related to the return of expired product, a
returns receivable will arise. Should the wholesalers not comply with our product exchange policy,
the amounts deducted by them for returns may not be collectible, and we would need to increase our
allowance for bad debts.
In estimating Medicaid rebates, we match the actual rebates to the quantity of product sold by
pharmacies on a product-by-product basis 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 by product 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 as of the period end
that are subject to the cash discounts.
Inventories
We maintain inventory reserves primarily for excess and obsolete inventory (due to the
expiration of shelf life of a product). In estimating inventory excess and obsolescence reserves,
we analyze on a product-by-product basis (i) the expiration date, (ii) our sales forecasts, and
(iii) historical demand. Judgment is required in determining whether the forecasted sales
information is sufficiently reliable to enable us to reasonably estimate excess and obsolete
inventory. If actual future usage and demand for our products are less favorable than those
projected by our management, 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 for our individual products.
Intangible Assets
We have intangible assets related to purchased technology and goodwill. The determination of
related estimated useful lives and whether or not these 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 and other intangible assets with no definitive lives 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 June 30, 2005, no impairment has been indicated.
Results of Operations
Three
months ended June 30, 2005 compared to the three months ended
June 30, 2004:
Total Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
% |
|
|
2005 |
|
2004 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net product sales |
|
$ |
4,290 |
|
|
$ |
4,090 |
|
|
$ |
200 |
|
|
|
5 |
% |
Total revenues for the quarter ended June 30, 2005, which consisted of net product sales only,
increased $200,000, or 5%, from the quarter ended June 30, 2004. The increase in total net product
sales is primarily the result of increased product sales of Acthar, partially offset by increases
in reserves recorded under our credit memoranda policy initiated in the second quarter of 2004 and
in reserves for Medicaid rebates. During the quarter ended June 30, 2005, net product sales of
Acthar and Nascobal were reduced by $229,000 for reserves for credit memoranda under the credit
memoranda policy for returns and $350,000 for Medicaid rebate reserves. The increased reserves for
Medicaid rebates reflect primarily higher per unit rebate levels, as well as increased purchases by
state Medicaid agencies. Net product sales of Acthar, which represented the largest percentage of
our total net product sales for the quarter
15
ended June 30, 2005, increased substantially as compared to the same period in 2004. The
increase in Acthar net product sales was due to both higher unit sales and price increases. The
increase in unit sales contributed approximately 75% of the increase in Acthar gross product sales
as compared to the quarter ended June 30, 2004. The remainder of the increase was attributed to
price increases of 9.5% and 5% that went into effect January 3, 2005 and April 1, 2005,
respectively. The increase in Acthar net product sales was offset by decreases in Nascobal net product
sales and VSL#3 net product sales, as compared to the second quarter of 2004. Net
product sales of Ethamolin and Glofil were comparable to second quarter of 2004 net product sales.
There were no VSL#3 net product sales for the second quarter of 2005, as our promotion agreement
with Sigma-Tau Pharmaceuticals expired in January 2005.
Approximately $550,000 in orders for Acthar, Nascobal and Ethamolin were received in March
2005 and shipped in early April 2005. We have adopted a practice of periodically evaluating
wholesaler inventory balances, and postponing shipments when we believe inventory levels are
already adequate. The revenue from these orders, net of applicable sales reserves, is included in
the second quarter of 2005 net product sales.
Our product exchange policy for expired product remains in effect for lots released prior to
June 1, 2004. Pursuant to our product exchange policy, during the quarter ended June 30, 2005 we
replaced vials of Acthar at no cost for certain returned product from Acthar batches that expired
in December 2004, and Ethamolin that expired in December 2004, and January and February 2005. The
gross sales value of these replacements, calculated using the unit prices in effect at June 30,
2005, was approximately $360,000 and $475,000, respectively, for Acthar and Ethamolin. Subsequent
to June 30, 2005, we will continue to replace Acthar and Ethamolin returned from these expired
lots. The replacement of product subsequent to June 30, 2005 for product that has expired and
future expiring product may displace future quarterly sales. The full extent of this displacement
is not ascertainable at this time as it is subject to market conditions and customer behavior not
within our control. The costs related to replacement products are reserved for and are included as
a component of Cost of Product Sales. Under our product exchange policy, as of June 30, 2005,
customers have requested the replacement of expired Acthar, Ethamolin and Nascobal with a gross
sales value, calculated using the unit prices in effect at June 30, 2005, of approximately
$2,480,000, primarily due to returns of Acthar and Ethamolin, which we have not yet replaced. We
intend to replace this expired product in the third and fourth quarter of 2005. These replacements
will likely displace future sales.
We review the amount of inventory at the wholesale level in order to help assess the demand
for Acthar, Ethamolin and Nascobal. We may choose to defer sales in situations where we believe
inventory levels are already adequate. We expect quarterly fluctuations in the net sales of all of
our products due to the timing of shipments, changes in wholesaler inventory levels, expiration
dates of products sold, the timing of replacement units shipped under our product exchange policy,
the impact of reserves provided for under our credit memoranda policy and the reallocation of
promotional efforts for each product.
Cost of Product Sales
Cost of product sales for the quarter ended June 30, 2005 increased $66,000, or 7%, to
$1,027,000 from $961,000 for the quarter ended June 30, 2004. Cost of product sales includes
material cost, packaging, warehousing and distribution, product liability insurance, royalties,
quality control, quality assurance and write-offs of excess or obsolete inventory. The increase in
cost of product sales is primarily due to an increase in spending of approximately $290,000 on
routine stability testing, primarily of H.P. Acthar Gel, and higher distribution expense resulting
from fees for distribution services. During the second quarter of 2004, one of our largest
wholesalers began charging a fee for distribution services provided to us. Another major wholesaler
implemented a similar fee for distribution services in the fourth quarter of 2004. The increase is
partially offset by decreases in direct material costs of approximately $110,000 resulting from the
change in product mix, and shipping related costs due to the expiration of the VSL#3 promotion
agreement with Sigma-Tau Pharmaceuticals in January 2005. The increase is also partially offset by
a decrease in replacement costs, due to Acthar and Nascobal shipments in the second quarter of 2005
that were subject to our credit memoranda return policy, rather than our product replacement
policy. Cost of product sales as a percentage of net product sales was 24% for the quarter ended
June 30, 2005, which was consistent with the quarter ended June 30, 2004. We expect per unit
material costs for Acthar to increase in the future due to higher contract manufacturing and
laboratory costs, which we anticipate could decrease our gross margin on Acthar.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
2,224 |
|
|
$ |
2,515 |
|
|
$ |
(291 |
) |
|
|
(12 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of total revenue |
|
|
52 |
% |
|
|
61 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
Selling, general and administrative expenses for the quarter ended June 30, 2005 decreased
$291,000 from the quarter ended June 30, 2004. The decrease was primarily due to lower salaries
and related expenses resulting from personnel changes and the realignment of the sales
force in 2005, and a reduction in access fees to Sigma-Tau Pharmaceuticals due to the expiration of
the promotion agreement in January 2005. The decreases were partially offset by higher professional
fees as compared to the quarter ended June 30, 2004. Selling, general and administrative expenses
decreased to 52% of revenue for the quarter ended June 30, 2005, from 61% of revenue for the
quarter ended June 30, 2004.
Research and Development
Research and development expenses for the quarter ended June 30, 2005 were $562,000, an
increase of $141,000 as compared to $421,000 for the quarter ended June 30, 2004. The costs
included in research and development relate primarily to our manufacturing site transfers and
medical and regulatory affairs compliance activities. The increase as compared to the same period
in 2004 was due primarily to increased regulatory fees and consulting costs, partially offset by
decreased Acthar site transfer costs.
Research and development expenses related to the manufacturing site transfer of Acthar for the
quarter ended June 30, 2005 were approximately $2,000, as compared to approximately $50,000 for the
quarter ended June 30, 2004. These amounts include costs associated with the Acthar bulk
manufacturing site transfer and the transfer of the potency assay to a new contract laboratory. In
2003, we transferred the Acthar final fill and packaging process to our contract manufacturer,
Chesapeake Biological Laboratories Inc. (CBL), and produced our first lot of Acthar finished
vials. In 2004, we transferred the Acthar active pharmaceutical ingredient (API) manufacturing
process to our contract manufacturer, BioVectra dcl (BioVectra), and produced the first BioVectra
API lot. We also selected a new contract laboratory to perform three bioassays associated with the
release of API and finished vials. Two of these bioassays have been successfully transferred to the
contract laboratory and were approved by the FDA in June 2005. We have experienced delays and cost
overruns in the validation of the third assay, potency. In 2004, we conducted additional studies
aimed at identifying critical differences in the way the potency assay is performed at the contract
laboratory as compared with the previous laboratory. Some differences were identified and
corrected, however, results were still not acceptable. Work on this assay transfer was restarted in
the second quarter of 2005. Our former contract manufacturer has agreed to perform any potency
assays we require through 2006. In the remainder of fiscal year 2005, the costs which we plan to
incur related to the API manufacturing site transfer and the bioassay transfers are expected to be
less than the costs incurred in 2004.
Depreciation and Amortization
Depreciation and amortization expense for the quarter ended June 30, 2005 increased to
$323,000 from $301,000 for the quarter ended June 30, 2004. This increase was due primarily to the
amortization of the $2.0 million we paid to Nastech in February of 2005 upon the approval of the
NDA for Nascobal nasal spray. The Nascobal purchased technology is being amortized over 15 years.
Other Income and Expense Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
June 30, |
|
Increase/ |
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Non-cash amortization of deemed discount on convertible debentures |
|
$ |
|
|
|
$ |
(131 |
) |
|
$ |
(131 |
) |
|
|
(100 |
)% |
Interest income |
|
|
23 |
|
|
|
13 |
|
|
|
10 |
|
|
|
77 |
% |
Interest expense |
|
|
(70 |
) |
|
|
(81 |
) |
|
|
(11 |
) |
|
|
(14 |
)% |
Other income |
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
|
% |
Rental income, net |
|
|
71 |
|
|
|
60 |
|
|
|
11 |
|
|
|
18 |
% |
We did not record any non-cash amortization of deemed discount on convertible debentures for
the quarter ended June 30, 2005 as compared to $131,000 for the quarter ended June 30, 2004. The
deemed discount was fully amortized as of March 15, 2005 when the convertible debentures were
scheduled to mature. The convertible debentures were issued in March 2002. In March 2005, the
maturity date of the convertible debentures was extended to April 15, 2005, on which date we
redeemed such convertible debentures in full in cash.
Interest
income for the quarter ended June 30, 2005 increased by $10,000 from the quarter
ended June 30, 2004. The increase was primarily due to higher interest rates in the second quarter
of 2005 compared to the same period in 2004. Interest expense for the
17
quarter
ended June 30, 2005 decreased by $11,000 from the quarter ended June 30, 2004. The
decrease was primarily due to a decrease in interest on our convertible debentures, which were
redeemed in April 2005, partially offset by interest expense on the $2.2 million promissory note we
issued to a wholly-owned subsidiary of Sigma-Tau, Defiante Farmaceutica Lda, in July 2004.
Rental income, net, for the quarter ended June 30, 2005 increased by $11,000 from the quarter
ended June 30, 2004. Rental income, net, arises primarily from the lease and sublease of our former
headquarters facility in Hayward, California. Although the current rental income from the sublessee
exceeds the current rental expense on the Hayward facility, there can be no assurance our sublessee
will not default on the sublease agreement, and if they were to do so, we would still be obligated
to pay rent on this property through November 2012.
Series B Preferred Stock Dividends
Preferred Stock dividends of $168,000 for each of the quarters ended June 30, 2005 and 2004
represent the 8% dividend paid quarterly to our Series B Preferred Stockholders. The dividend for
the quarters ended June 30, 2005 and June 30, 2004 were paid in common stock and cash. 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 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.
Six months ended June 30, 2005 compared to the six months ended June 30, 2004:
Total Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Net product sales |
|
$ |
8,788 |
|
|
$ |
9,238 |
|
|
$ |
(450 |
) |
|
|
(5 |
)% |
Total revenues for the six months ended June 30, 2005, which consisted of net product sales
only, decreased $450,000, or 5%, from the six months ended June 30, 2004. The decrease in total net
product sales is primarily the result of reserves recorded under our credit memoranda policy
initiated in the second quarter of 2004 and reserves for Medicaid rebates. Gross product sales were
slightly higher in the six months ended June 30, 2005 in comparison to the six months ended June
30, 2004. During the six months ended June 30, 2005, net product sales of Acthar and Nascobal were
reduced by $832,000 for reserves for credit memoranda under the credit memoranda policy for returns
and $587,000 for reserves under Medicaid rebates.
Net product sales of Acthar, which represented the largest percentage of our total net product
sales for the six months ended June 30, 2005, increased significantly as compared to the same
period in 2004. The increase in Acthar net product sales was due to both increased unit sales and
price increases of 9.5% and 5% that went into effect January 3, 2005 and April 1, 2005,
respectively. Approximately 70% of the increase in Acthar product sales was attributed to increased
unit sales.
The
increase in Acthar net product sales was offset by decreases in net product
sales of Nascobal and VSL#3, as compared to the same period of 2004. Inventory of Nascobal at the
wholesale level has declined as compared to the beginning of 2005, based on information provided by
our major wholesaler customers. The decrease in Nascobal sales was due in part to the reduction of inventories
held by our wholesaler customers during the six months ended June 30, 2005, and partly a result of
lower prescription demand as compared to the same period in 2004. Net product sales of Ethamolin
and Glofil were comparable to the same period of 2004 net product sales. VSL#3 net product sales
were minimal in 2005, as our promotion agreement with Sigma-Tau Pharmaceuticals expired in January
2005.
Our product exchange policy for expired product remains in effect for lots released prior to
June 1, 2004. Pursuant to our product exchange policy, during the six months ended June 30, 2005,
we replaced vials of Acthar at no cost for certain returned product from Acthar batches that
expired in January and December 2004, having a gross sales value of approximately $590,000, and
Ethamolin that expired in December 2004, and January and February 2005, having a gross sales value
of approximately $525,000, calculated using the unit prices in effect at June 30, 2005. Subsequent
to June 30, 2005, we will continue to replace Acthar and Ethamolin returned from these expired
lots. The replacement of product subsequent to June 30, 2005 for product that has expired and
future expiring product may displace future quarterly sales. The full extent of this displacement
is not ascertainable at this time as it is subject to market conditions and customer behavior not
within our control. The costs related to replacement products are reserved for and are included as
a component of Cost of Product Sales. Under our product exchange policy, as of June 30, 2005,
customers have requested
18
the
replacement of expired Acthar, Ethamolin and Nascobal with a gross sales value, calculated using the unit prices in effect at June 30, 2005, of
approximately $2,480,000, primarily due to returns of Acthar and
Ethamolin, which we
have not yet replaced. We intend to replace this
expired product in the third and fourth quarter of 2005. These replacements will likely displace
future sales.
Cost of Product Sales
Cost of product sales for the six months ended June 30, 2005 decreased $42,000, or 2%, to
$1,775,000 from $1,817,000 for the six months ended June 30, 2004. Decreases in direct material
costs of approximately $250,000 resulting from the change in the mix of products sold, and shipping
related costs of approximately $100,000 due to the expiration of the VSL#3 promotion agreement with
Sigma-Tau Pharmaceuticals in January 2005 were partially offset
by increases in spending of approximately $270,000 on routine stability testing, primarily of H.P. Acthar Gel, higher distribution
expense resulting from fees for distribution services and increases in royalties on Acthar
resulting from increased sales. Cost of product sales as a percentage of net product sales was 20%
for the six months ended June 30, 2005, which was consistent with the same period in 2004. We
expect per unit material costs for Acthar to increase in the future due to higher contract
manufacturing and laboratory costs, which we anticipate could decrease our gross margin on Acthar.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
|
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
4,842 |
|
|
$ |
5,543 |
|
|
$ |
(701 |
) |
|
|
(13 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of total revenue |
|
|
55 |
% |
|
|
60 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses for the six months ended June 30, 2005 decreased
$701,000 from the six months ended June 30, 2004, primarily due to decreased spending on sales and
marketing, including market research and marketing programs, and lower salaries and related
expenses resulting from personnel changes. A reduction in access fees to Sigma-Tau
Pharmaceuticals, due to the expiration of the VSL#3 promotion agreement in January 2005, contributed to lower expenses in the six months ended June 30, 2005. The decreases were partially
offset by severance expenses associated with the resignation of our former Vice President of Sales
and Marketing and the realignment of the sales force in 2005. Selling, general and administrative
expenses decreased to 55% of revenue for the six months ended June 30, 2005, from 60% of revenue
for the six months ended June 30, 2004.
Research and Development
Research and development expenses for the six months ended June 30, 2005 were $1,061,000, an
increase of $62,000 as compared to $999,000 for the six months ended June 30, 2004. The increase as
compared to the same period in 2004 was due primarily to increased regulatory fees, patent-related
legal fees and consulting costs, offset by decreased Acthar manufacturing site transfer costs.
Research and development expenses for the six months ended June 30, 2005 include approximately
$10,000 related to the manufacturing site transfer of Acthar, as compared to approximately $240,000
for the six months ended June 30, 2004. These amounts include costs associated with the Acthar bulk
manufacturing site transfer and the transfer of the potency assay to a new contract laboratory.
Depreciation and Amortization
Depreciation and amortization expense for the six months ended June 30, 2005 increased to
$634,000 from $599,000 for the six months ended June 30, 2004, primarily due to the amortization of
the $2.0 million we paid to Nastech in February of 2005 upon the approval of the NDA for Nascobal
nasal spray. The Nascobal purchased technology is being amortized over 15 years.
Other Income and Expense Items
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
June 30, |
|
Increase/ |
|
% |
|
|
2005 |
|
2004 |
|
(Decrease) |
|
Change |
|
|
(in $000s) |
Non-cash amortization of deemed discount on convertible debentures |
|
$ |
(108 |
) |
|
$ |
(262 |
) |
|
$ |
(154 |
) |
|
|
(59 |
)% |
Interest income |
|
|
58 |
|
|
|
24 |
|
|
|
34 |
|
|
|
142 |
% |
Interest expense |
|
|
(209 |
) |
|
|
(164 |
) |
|
|
45 |
|
|
|
27 |
% |
Other income |
|
|
1 |
|
|
|
3 |
|
|
|
(2 |
) |
|
|
(67 |
)% |
Rental income, net |
|
|
114 |
|
|
|
142 |
|
|
|
(28 |
) |
|
|
(20 |
)% |
19
Non-cash amortization of deemed discount on convertible debentures for the six months ended
June 30, 2005 decreased by $154,000 from the six months ended June 30, 2004, due to the deemed
discount being 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 six months ended June 30, 2005 increased by $34,000 from the six
months ended June 30, 2004. The increase was primarily due to higher cash balances during the first
quarter of 2005 and higher interest rates in the six months ended June 30, 2005. Interest expense
for the six months ended June 30, 2005 increased by $45,000 from the six months ended June 30,
2004. Interest expense consists primarily of interest on our convertible debentures and on the $2.2
million promissory note we issued to a wholly-owned subsidiary of Sigma-Tau, Defiante Farmaceutica
Lda, in July 2004. The increase was primarily due to interest on the $2.2 million promissory note,
partially offset by the decrease in interest expense on convertible debentures redeemed in April
2005.
Rental income, net, for the six months ended June 30, 2005 decreased by $28,000 from the six
months ended June 30, 2004. The decrease in rental income, net, relates primarily to a sublease
that was not renewed on our building in Carlsbad, California. Rental income, net, arises primarily
from the lease and sublease of our former headquarters facility in Hayward, California.
Series B Preferred Stock Dividends
Preferred Stock dividends of $336,000 and $340,000 for the six months ended June 30, 2005 and
2004, respectively, represent the 8% dividends paid quarterly to our Series B Preferred
Stockholders. The dividends for the six months ended June 30, 2005 and June 30, 2004 were paid in
common stock and cash.
The non-cash deemed dividend of $84,000 for the six months ended June 30, 2005 is related to
the revaluation of the warrants issued to the Series B Preferred Stockholders, which resulted in an
incremental value of $84,000 that decreased the carrying value of the preferred stock. In
connection with the revaluation, the Company recorded $84,000 related to the beneficial conversion
feature on the Series B Preferred Stock as an additional deemed dividend, which increased the
carrying value of the Series B Preferred Stock. For the six months ended June 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. Through June 30, 2005, we have raised total net proceeds of $63.2 million. We
have also funded our activities to date to a lesser extent through product sales.
At June 30, 2005, we had cash and cash equivalents of $4,429,000 compared to $8,729,000 at
December 31, 2004. The decrease in our cash balance is due primarily to the redemption of our
convertible debentures in cash totaling $4 million in April 2005. At June 30, 2005, our working
capital was $4,210,000 compared to $5,082,000 at December 31, 2004. The decrease in our working
capital was principally due to the $2 million payment we made to Nastech upon approval of the NDA
for the Nascobal spray in February 2005.
As of March 31, 2005, we had 8% convertible debentures with a face value of $4 million
outstanding, $2 million issued to Defiante, and $2 million issued to SF Capital Partners Ltd.
(SFCP), an institutional investor. Under the original terms of the debentures, we could redeem
SFCPs debenture at maturity for stock, subject to certain limitations, and we could redeem
Defiantes debenture for stock at maturity, provided the market price of our common stock at the
time of redemption was greater than $1.50 per share (representing the five day average closing sale
price of our common stock immediately prior to March 15, 2002). If the price of our common stock
was not greater than $1.50 per share on March 15, 2005, we would have been required to pay $2
million in cash to Defiante to redeem the convertible debenture.
The original maturity date of the debentures was March 15, 2005. On March 8, 2005, we entered
into an amendment to the debenture with Defiante, extending the maturity date to April 15, 2005. On
March 10, 2005, we entered into an amendment to the
20
debenture with 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. On
April 15, 2005, we redeemed both convertible debentures in cash totaling $4 million, plus accrued
interest.
In connection with our acquisition of Nascobal, we also agreed to acquire the rights to
Nascobal nasal spray, an alternative dosage form of Vitamin B-12, for which there are two
contingent payments to Nastech of $2 million each. In February 2005, upon approval by the FDA of an
NDA filed by Nastech in December 2003 for Nascobal nasal spray, Nastech was obligated to transfer
the NDA to us, and we were obligated to pay $2 million to Nastech. We made the $2 million payment
to Nastech in February 2005. Upon subsequent issuance of a United States patent including claims
for a nasal spray that treats any indication in the approved NDA, we are obligated to pay an
additional $2 million to Nastech. The United States patent applications for the Nascobal nasal
spray have been filed by Nastech.
In July 2004, we issued a $2.2 million secured promissory note to Defiante. The note is
secured by the Nascobal intellectual property including the NDA for the spray formulation. The
note, bearing interest at 9.83% per annum, requires interest only payments for the first twelve
months, with monthly principal and interest payments thereafter through August 2008.
It is currently our customers standard practice to deduct from payments to us the amount of
the purchase price of expired product, or returns receivable, that they have requested to return.
The returns receivable amounted to $501,000 at June 30, 2005. Customers have indicated that they
will reimburse us for these deductions upon the replacement of units in accordance with our product
exchange policy, however, our experience has been the timing of such reimbursements is slower than
the collection of our normal trade receivables. As of June 30, 2005, replacement units have been
shipped relating to approximately 6% of amounts owing to us and we are seeking reimbursement from
these customers. As long as our customers standard practice is to deduct amounts related to the
return of expired product, a returns receivable will arise. Should our customers not comply with
our product exchange policy, the amounts deducted by them for returns may not be collectible.
In August 2004, Mr. Charles J. Casamento resigned as Chairman, President and CEO of the
Company. Under the separation agreement entered into by us and Mr. Casamento, and consistent with
certain terms of his employment agreement, we (i) will continue to pay Mr. Casamento his regular
monthly base salary of $38,208 for 18 months, (ii) paid the prorated portion of his 2004 annual
bonus potential in the amount of $136,294 in August 2004, and (iii) extended the exercise period
for 18 months of 129,251 stock options with an exercise price of $1.25 per share. All other stock
options held by Mr. Casamento expired on November 3, 2004. Although certain payments are being paid
on a monthly basis over the 18 months, Mr. Casamento will not be performing further services for
us, other than part-time consulting services, if requested by the Company.
In June 2004, we implemented a transition plan for expired product returns from a product
exchange policy to a credit memoranda policy. Under the credit memoranda policy, a credit
memorandum will be issued for the original purchase price of the returned product, for expired
product returned from lots released after May 31, 2004. We expect that cash flow will be negatively
impacted when future credit memoranda are issued for expired product returned from lots subject to
our credit memoranda policy.
In January 2003, we completed a private placement of Series B Convertible Preferred Stock and
warrants to purchase common stock to various healthcare investors. Our gross proceeds from the
private placement were $10 million. Net of issuance costs, our proceeds were $9.4 million. The
Series B Preferred Stock had an aggregate stated value at the time of issuance of $10 million and
is entitled to a quarterly dividend at an initial rate of 8% per year, which rate will increase to
10% per year on and after January 1, 2006, and to 12% on and after January 1, 2008. The dividends
are paid in cash on a quarterly basis. In addition, on the occurrence of designated events the
dividend rate will increase by an additional 6% per year.
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 Convertible Preferred Stock.
21
The Series B Preferred Stock is entitled to a liquidation preference over our common stock and
Series A Preferred Stock upon a liquidation, dissolution or winding up of Questcor. The Series B
Preferred Stock is convertible at the option of the holder into our common stock at a conversion
price of $0.9412 per share, subject to certain anti-dilution adjustments. To date, Series B
Preferred Stock having a stated value of $1.6 million and accrued and unpaid dividends, net of
prepaid dividends, of $16,000 have been converted into 1,749,939 shares of common stock. We have the
right commencing on January 1, 2006 (assuming specified conditions are met) to redeem the Series B
Preferred Stock at a price of 110% of stated value, together with all accrued and unpaid dividends
and arrearage interest. In addition, upon the occurrence of designated Optional Redemption Events,
the holders have the right to require us to redeem the Series B Preferred Stock at 100% of its
stated value ($8.4 million at June 30, 2005), together with all accrued and unpaid dividends and
accrued interest. The terms of the Series B Preferred Stock contain a variety of affirmative and
restrictive covenants, including limitations on indebtedness and liens. Each share of Series B
Preferred Stock is generally entitled to a number of votes equal to 0.875 times the number of
shares of common stock issuable upon conversion of such share of Series B Preferred Stock. The
purchasers of the Series B Preferred Stock also received for no additional consideration warrants
exercisable for an aggregate of 3,399,911 shares of our common stock at an exercise price of
$1.0824 per share, subject to certain anti-dilution adjustments. In June 2003, the exercise price
of the warrants was adjusted to $0.9412 per share. In March 2005, the expiration date of the
warrants was extended from January 2007 to January 2008. In January 2004 warrants to purchase
373,990 shares of common stock were surrendered as consideration, along with cash, for the issuance
of 373,990 shares of common stock.
Based on our internal forecasts and projections, we believe that our cash on hand at June 30,
2005, and the net cash flows generated from operations will be sufficient to fund operations
through at least June 30, 2006, unless a substantial portion of our cash is used for product
acquisition or our revenues are significantly less than we expect.
Our future funding requirements will depend on many factors, including: the timing and extent
of product sales; returns of expired product; the acquisition and licensing of products,
technologies or compounds, if any; the repositioning of our product portfolio; our ability to
manage growth; timing of the payment to Nastech relating to the patent approvals for the nasal
spray formulation of Nascobal; 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; the timing and successful completion of the Acthar
bioassay transfer; payment of dividends and compliance to prevent additional dividend events; any
expansion or acceleration of our development programs or optional redemption events, and other
factors.
If our revenues do not provide cash flows from operations in an amount sufficient to meet our
obligations, or if we are unable to maintain compliance with certain covenants when applicable and
thus avoid the payment of additional dividends of 6% to the holders of our Series B Convertible
Preferred Stock, or we do not have sufficient funds to make the contingent payment, if, and when
due to Nastech for the patent approvals of the new nasal spray form of Nascobal, 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.
RISK FACTORS
The following risk factor supplements the risk factors contained in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2004 as filed with the Securities and Exchange Commission on
March 31, 2005. You should carefully consider the following risk factor as well as those contained
our Annual Report on Form 10-K. Each of these risks could adversely affect our business, financial
condition and results of operations, as well as adversely affect the value of an investment in our
common stock.
The Company has experienced changes in key personnel which will have an uncertain impact on future operations.
On February 18, 2005, Mr. James L. Fares was named President and Chief Executive Officer,
succeeding Mr. Charles J. Casamento who resigned as Chairman, President and Chief Executive Officer
on August 5, 2004. On March 8, 2005, Mr. Steve Cartt was named Executive Vice President of
Commercial Development. On March 21, 2005, Ms. Barbara J. McKee was named Principal Accounting
Officer. Mr. Timothy Morris resigned as Senior Vice President of Finance and Administration and
Chief Financial Officer effective November 9, 2004. On March 3, 2005, Mr. R. Jerald Beers resigned
as Vice President, Sales and Marketing. If the transition to a new executive team is unsuccessful,
our business could be harmed. We are highly dependent on the services of our President and
22
Chief Executive Officer, Mr. James L. Fares and our Executive Vice President of Commercial
Development, Mr. Steve Cartt. If we were to lose Mr. Fares or Mr. Cartt, as employees, our business
could be harmed.
On August 5, 2005, Barbara J. McKee, our former Director of Finance and Principal Accounting
Officer, resigned from her position with us. While we are currently searching for a successor
candidate to serve as our permanent Chief Financial Officer, it may take us longer than anticipated
to find a suitable successor or to integrate any such successor fully into our operations, either
of which may adversely affect our ability to execute our business strategy and our business
results. The absence of a permanent Chief Financial Officer may have a material effect on our
internal controls over financial reporting. In addition, if we are not able to find a permanent
Chief Financial Officer in the near future, we may not be able to file our upcoming periodic
reports with the Securities and Exchange Commission, or SEC, in a timely manner, which may have a
negative impact on the market price of our common stock.
We do not carry key person life insurance for our senior management or other personnel.
Additionally, the future potential growth and expansion of our business is expected to place
increased demands on our management skills and resources. Although some changes in staffing levels
are expected during 2005, recruiting and retaining management and operational personnel to perform
sales and marketing, financial operations, business development, regulatory affairs, quality
assurance, medical affairs and contract manufacturing in the future will also be critical to our
success. We do not know if we will be able to attract and retain skilled and experienced management
and operational personnel in the future on acceptable terms given the intense competition among
numerous pharmaceutical and biotechnology companies for such personnel. If we are unable to hire
necessary skilled personnel in the future, our business could be harmed.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at June 30, 2005 has not changed materially from December 31,
2004, and reference is made to the more detailed disclosures of market risk included in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2004 as filed with the Securities and
Exchange Commission on March 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 Principal Accounting Officer, as appropriate, to allow for timely
decisions regarding required disclosure. In designing and evaluating the disclosure controls and
procedures, management recognizes that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control objectives, and
management is required to apply its judgment in evaluating the cost-benefit relationship of
possible controls and procedures.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Principal
Accounting 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 Principal Accounting 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 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Not applicable
23
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Company held its 2005 Annual Meeting of Shareholders on June 2, 2005. The following matters
received the votes at the 2005 Annual Meeting of Shareholders as set forth below:
|
1. |
|
Election of Directors to hold office until the 2006 Annual Meeting of Shareholders and
until their successors are duly elected and qualified. |
|
|
|
|
|
|
|
|
|
|
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Votes For |
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Votes Withheld |
Albert Hansen |
|
|
56,485,964 |
|
|
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510,920 |
|
Neal Bradsher |
|
|
56,503,217 |
|
|
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493,667 |
|
James L. Fares |
|
|
56,236,673 |
|
|
|
760,211 |
|
Howard D. Palefsky |
|
|
56,242,744 |
|
|
|
754,140 |
|
Jon S. Saxe |
|
|
56,199,224 |
|
|
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797,660 |
|
Virgil D. Thompson |
|
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56,101,736 |
|
|
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895,148 |
|
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2. |
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Ratification of Odenberg Ullakko Muranishi & Co. LLP as the Companys independent
auditors for the fiscal year ending December 31, 2005. |
|
|
|
|
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For: |
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56,795,242 |
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Against: |
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112,249 |
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Abstain: |
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89,393 |
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ITEM 5. OTHER INFORMATION
Not applicable
ITEM 6. EXHIBITS
|
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Exhibit No. |
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Description |
31
|
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Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32*
|
|
Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002. |
|
|
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
|
|
|
QUESTCOR PHARMACEUTICALS, INC. |
|
|
|
|
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|
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Date: August 12, 2005
|
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By:
|
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/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:
|
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/s/ JAMES L. FARES |
|
|
|
|
|
|
|
|
|
|
|
|
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James L. Fares |
|
|
|
|
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Acting Chief Financial Officer and Principal Accounting |
|
|
|
|
|
|
Officer |
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|
25
Exhibit Index
|
|
|
Exhibit No. |
|
Description |
31
|
|
Certifications pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
|
|
|
32*
|
|
Certifications pursuant to Section 906 of the Public Company Accounting Reform and Investor Act of 2002. |
|
|
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
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:
a) designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating
to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such
evaluation; and
c) disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants internal
control over financial reporting; and
5. The registrants 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
b) any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting.
Date: August 12, 2005
|
|
|
|
|
|
|
|
|
/s/ JAMES L. FARES
|
|
|
James L. Fares |
|
|
Chief Executive Officer |
|
Certification of Principal Accounting 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:
|
a) |
|
designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
|
|
b) |
|
evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
c) |
|
disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. The registrants 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 |
|
|
b) |
|
any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
Date: August 12, 2005
|
|
|
|
|
|
|
|
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/s/ JAMES L. FARES
|
|
|
James L. Fares |
|
|
Acting Chief Financial Officer
and Principal Accounting Officer |
|
exv32
EXHIBIT 32
CERTIFICATIONS
On August 12, 2005, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for
the quarter ended June 30, 2005 (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 June 30, 2005 (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: August 12, 2005
|
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/s/ JAMES L. FARES
|
|
|
|
|
|
|
|
|
|
James L. Fares |
|
|
|
|
Chief Executive Officer |
|
|
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.
Certification of Principal Accounting 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 June 30, 2005 (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: August 12, 2005
|
|
/s/ JAMES L. FARES |
|
|
|
|
|
|
|
|
|
James L. Fares |
|
|
|
|
Acting Chief Financial Officer and Principal Accounting Officer
|
|
|
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.