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, 2008
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION
13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934. |
FOR THE TRANSITION PERIOD FROM TO
COMMISSION FILE NUMBER: 001-14758
QUESTCOR PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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CALIFORNIA
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33-0476164 |
(State or other jurisdiction
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(I.R.S. Employer |
of incorporation or organization)
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Identification No.) |
3260 Whipple Road
Union City, CA 94587-1217
(Address of Principal Executive Offices)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (510) 400-0700
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter prior that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer o |
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Non-accelerated filer þ
(Do not check if a smaller reporting company) |
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Smaller reporting company o |
Indicate by check mark whether Registrant is a shell company (as defined in Rule 12b-2 of the
Act). Yes o No þ
As
of August 13, 2008 there were 66,376,856 shares of the Registrants common stock, no par
value per share, outstanding.
QUESTCOR PHARMACEUTICALS, INC.
FORM 10-Q
TABLE OF CONTENTS
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT SHARE AMOUNTS)
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June 30, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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(Note 1) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
20,476 |
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$ |
15,939 |
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Short-term investments |
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18,418 |
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14,273 |
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Total cash, cash equivalents and short-term investments |
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38,894 |
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30,212 |
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Accounts receivable, net of allowance for doubtful accounts
of $118 and $57 at June 30, 2008 and December 31, 2007,
respectively |
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21,587 |
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23,639 |
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Inventories, net |
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2,446 |
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2,365 |
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Prepaid expenses and other current assets |
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563 |
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778 |
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Deferred tax assets |
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8,525 |
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14,879 |
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Total current assets |
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72,015 |
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71,873 |
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Property and equipment, net |
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443 |
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522 |
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Purchased technology, net |
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3,819 |
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3,967 |
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Goodwill |
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299 |
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299 |
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Deposits and other assets |
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710 |
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744 |
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Deferred tax assets, net |
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1,043 |
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1,043 |
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Total assets |
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$ |
78,329 |
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$ |
78,448 |
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LIABILITIES, PREFERRED STOCK AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,969 |
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$ |
1,777 |
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Accrued compensation |
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973 |
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1,945 |
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Sales-related reserves |
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12,402 |
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8,176 |
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Income taxes payable |
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1,330 |
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Other accrued liabilities |
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1,576 |
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1,492 |
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Total current liabilities |
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17,920 |
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14,720 |
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Lease termination and deferred rent liabilities |
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1,675 |
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1,869 |
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Other non-current liabilities |
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3 |
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7 |
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Preferred stock, no par value, 7,500,000 shares authorized; none
and 2,155,715 Series A shares issued and outstanding at June 30,
2008 and December 31, 2007, respectively (aggregate liquidation
preference of $10,000 at December 31, 2007) |
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5,081 |
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Shareholders equity: |
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Common stock, no par value, 105,000,000 shares authorized;
69,066,449 and 70,118,166 shares issued and outstanding at
June 30, 2008 and December 31, 2007, respectively |
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100,316 |
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108,387 |
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Accumulated deficit |
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(41,602 |
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(51,670 |
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Accumulated other comprehensive gain |
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17 |
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54 |
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Total shareholders equity |
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58,731 |
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56,771 |
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Total liabilities, preferred stock and shareholders equity |
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$ |
78,329 |
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$ |
78,448 |
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See accompanying notes.
3
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Net sales |
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$ |
24,898 |
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$ |
4,144 |
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$ |
44,030 |
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$ |
7,845 |
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Cost of sales (exclusive of amortization of purchased technology) |
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2,190 |
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914 |
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3,509 |
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1,764 |
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Gross profit |
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22,708 |
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3,230 |
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40,521 |
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6,081 |
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Operating costs and expenses: |
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Selling, general and administrative |
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4,855 |
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4,747 |
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9,921 |
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10,297 |
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Research and development |
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3,555 |
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951 |
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5,526 |
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2,091 |
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Depreciation and amortization |
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123 |
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125 |
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245 |
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248 |
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Total operating costs and expenses |
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8,533 |
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5,823 |
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15,692 |
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12,636 |
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Income (loss) from operations |
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14,175 |
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(2,593 |
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24,829 |
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(6,555 |
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Other income (expense): |
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Interest income |
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244 |
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181 |
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608 |
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391 |
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Other income, net |
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247 |
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11 |
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240 |
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Gain on sale of product rights |
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448 |
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448 |
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Total other income |
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244 |
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876 |
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619 |
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1,079 |
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Income (loss) before income taxes |
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14,419 |
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(1,717 |
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25,448 |
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(5,476 |
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Income tax expense |
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5,625 |
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10,113 |
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Net income (loss) |
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8,794 |
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(1,717 |
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15,335 |
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(5,476 |
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Deemed dividend on Series A preferred stock |
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5,267 |
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Net income (loss) applicable to common shareholders |
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$ |
8,794 |
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$ |
(1,717 |
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$ |
10,068 |
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$ |
(5,476 |
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Net income (loss) per share applicable to common shareholders: |
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Basic |
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$ |
0.13 |
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$ |
(0.02 |
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$ |
0.14 |
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$ |
(0.08 |
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Diluted |
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$ |
0.12 |
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$ |
(0.02 |
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$ |
0.14 |
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$ |
(0.08 |
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Shares used in computing net income (loss) per share applicable to
common shareholders: |
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Basic |
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69,205 |
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68,989 |
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69,576 |
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68,882 |
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Diluted |
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72,889 |
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68,989 |
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73,496 |
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68,882 |
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See accompanying notes.
4
QUESTCOR PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
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Six Months Ended |
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June 30, |
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2008 |
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2007 |
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OPERATING ACTIVITIES |
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Net income (loss) |
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$ |
15,335 |
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$ |
(5,476 |
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Adjustments to reconcile net income (loss) to net cash
provided by (used in) operating activities: |
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Share-based compensation expense |
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3,088 |
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792 |
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Deferred income taxes |
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6,354 |
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Amortization of investments |
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(354 |
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Depreciation and amortization |
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244 |
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248 |
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Loss on disposal of equipment |
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12 |
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Gain on sale of product rights |
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(448 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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2,052 |
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568 |
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Inventories |
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(81 |
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551 |
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Prepaid expenses and other current assets |
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215 |
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256 |
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Accounts payable |
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1,192 |
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(783 |
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Accrued compensation |
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(972 |
) |
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(190 |
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Sales-related reserves |
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4,226 |
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(319 |
) |
Income taxes payable |
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(1,330 |
) |
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Other accrued liabilities |
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84 |
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(57 |
) |
Other non-current liabilities |
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(198 |
) |
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8 |
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Net cash flows provided by (used in) operating activities |
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29,855 |
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(4,838 |
) |
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INVESTING ACTIVITIES |
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Purchase of property and equipment |
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(17 |
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(65 |
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Acquisition of purchased technology |
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(300 |
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Purchase of short-term investments |
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(31,714 |
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(14,897 |
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Proceeds from the sale and maturities of short-term investments |
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27,886 |
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7,250 |
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Net proceeds from sale of product rights |
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448 |
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Changes in deposits and other assets |
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34 |
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(11 |
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Net cash flows used in investing activities |
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(3,811 |
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(7,575 |
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FINANCING ACTIVITIES |
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Issuance of common stock, net |
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671 |
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407 |
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Repurchase of Series A preferred stock |
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(10,348 |
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Repurchase of common stock |
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(11,830 |
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Net cash flows provided by (used in) financing activities |
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(21,507 |
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407 |
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Increase (decrease) in cash and cash equivalents |
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4,537 |
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(12,006 |
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Cash and cash equivalents at beginning of period |
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15,939 |
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15,937 |
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Cash and cash equivalents at end of period |
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$ |
20,476 |
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$ |
3,931 |
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See accompanying notes.
5
QUESTCOR PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. ORGANIZATION AND BASIS OF PRESENTATION
Organization
Questcor Pharmaceuticals, Inc. (the Company or Questcor) is a pharmaceutical company that
markets two commercial products, H.P. Acthar® Gel (repository corticotropin injection)
and Doral® (quazepam). H.P. Acthar Gel (Acthar) is an injectable drug that is approved
for the treatment of certain disorders with an inflammatory component, including the treatment of
exacerbations associated with multiple sclerosis (MS). In addition, Acthar is not indicated for,
but is used in treating patients with infantile spasms (IS), a rare form of refractory childhood
epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological
disorder. Doral is indicated for the treatment of insomnia characterized by difficulty in falling
asleep, frequent nocturnal awakenings, and/or early morning awakenings. The Company is also
developing QSC-001, a unique orally disintegrating tablet formulation of hydrocodone bitartrate and
acetaminophen for the treatment of moderate to moderately severe pain in patients with swallowing
difficulties.
In August 2007, the Company announced its Acthar-centric business strategy. As part of the new
strategy, the Company implemented a new pricing level for Acthar which took effect August 27, 2007.
The Company also expanded its sponsorship of Acthar patient assistance and co-pay assistance
programs, which provide an important safety net for uninsured and under-insured patients using
Acthar, and established a group of product service consultants and medical science liaisons to work
with healthcare providers who administer Acthar. As a result, the Company is not aware of a single
patient who needs Acthar but has not been able to access it. This was not the case before the
Companys strategy change. Because the Company is now economically viable, the Company has
significantly improved its ability to maintain the long-term availability of Acthar and fund
important medical research projects that have the goal of improving patient care.
The Company has been working closely with the neurology community to identify promising new
projects for which it can provide needed financial support. The
Company is providing
support to leading researchers in their efforts to better understand the underlying disease
processes that cause infantile spasms, a subject for which there has been little research funding
in recent decades. The Company is also in discussions with experts in other disease states with
high unmet medical needs for which there is a potential therapeutic role for Acthar.
Acthar is currently approved in the U.S. for the treatment of exacerbations associated with MS
and many other conditions with an inflammatory component. No drug is approved in the U.S. for the
treatment of IS, a potentially life-threatening disorder that typically begins in the first year of
life. However, pursuant to guidelines published by the American Academy of Neurology and the Child
Neurology Society, many child neurologists use Acthar to treat infants afflicted with IS. In June
2006, the Company submitted a Supplemental New Drug Application (sNDA) to the FDA and is
currently pursuing formal agency approval of an indication for the use of Acthar in the treatment
of IS. In May 2007, the Company received an action letter from the FDA indicating that its sNDA
was not approvable in its current form. In November 2007, the Company met with the FDA to further
discuss its sNDA. At the meeting, the FDA concurred with the Companys suggested pathway to
resubmit the application with additional information. The Companys efforts are focused on two
major projects involving the compilation and analysis of efficacy data from prior, randomized
controlled trials and safety data from prior studies as well as historical patient records. The
Companys goal is to submit the additional information to the FDA by the end of 2008. At this time,
the FDA is not requiring the Company to conduct a clinical trial to support its resubmission.
The Companys strategy is to focus on growth initiatives for Acthar, continue the development
of QSC-001, improve operational efficiencies, and return cash to shareholders through repurchases
of its common stock. The Companys most important growth initiative is the planned 2008
resubmission to the FDA of the sNDA in support of a new indication for IS. Should the FDA grant
approval for this indication, the Company could then begin promoting the use of Acthar in this
indication, something the Company is presently prohibited from doing. The Company believes that
such promotion has the potential to increase usage of Acthar in IS beyond current levels. The
Company is also currently working on a number of initiatives aimed at developing future growth
opportunities for Acthar in therapeutic areas other than IS. These include in-depth evaluation of
uses that are currently a part of Acthars extensive list of on-label indications. For example, the
Company has observed some continued usage, as well as favorable insurance coverage, in the subset
of MS patients who do not respond to, or who cannot tolerate, IV corticosteroids, the first-line
treatment of most neurologists for MS flares. Market research indicates that many MS flare patients
may be in this subset. In response, the Company has modestly increased its promotional efforts
directed to MS specialists to further explore the potential of this
6
opportunity. The Company is also looking at other indications that could provide additional
patient benefits and sales growth potential for Acthar.
On May 5, 2008, the Company announced that its board of directors approved the decision to
switch the listing of its common stock from the American Stock Exchange to the NASDAQ Stock Market
LLC. Effective May 16, 2008, the Company began trading on NASDAQ under the trading symbol QCOR.
Basis of Presentation
The Company has determined that it operates in one business segment, pharmaceutical products.
The accompanying unaudited consolidated financial statements of the Company have been prepared in
accordance with U.S. generally accepted accounting principles and applicable Securities and
Exchange Commission regulations for interim financial information. These financial statements do
not include all of the information and footnotes required by U.S. generally accepted accounting
principles for complete financial statements. The unaudited financial statements should be read in
conjunction with the audited financial statements and related footnotes included in the Companys
Annual Report on Form 10-K for the year ended December 31, 2007. The accompanying consolidated
balance sheet at December 31, 2007 has been derived from the audited financial statements at that
date. In the opinion of the Companys management, all adjustments (consisting of normal recurring
adjustments) considered necessary for the fair presentation of interim financial information have
been included. Operating results for the interim period presented are not necessarily indicative of
the results that may be expected for the year ending December 31, 2008 or for any future interim
period. The consolidated financial statements include the accounts of the Company and its wholly
owned subsidiary. All significant intercompany accounts and transactions have been eliminated.
2. SHARE-BASED COMPENSATION
Effective January 1, 2006, the Company adopted the fair value recognition provisions of
Statement of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based Payment
(SFAS No. 123(R)), using the modified-prospective transition method. Under that transition
method, share-based compensation cost related to employees and non-employee members of the
Companys board of directors includes the compensation cost related to share-based payments granted
to employees and non-employee members of the board of directors through, but not yet vested as of
December 31, 2005, based on the grant-date fair value estimated in accordance with the provisions
of SFAS No. 123, Accounting for Stock-Based Compensation (SFAS No. 123), and compensation cost
for share-based payments granted to employees and non-employee members of the board of directors
subsequent to December 31, 2005, based on the grant-date fair value estimated in accordance with
the provisions of SFAS No. 123(R).
Share-based compensation expense recorded for awards granted to employees and non-employee
members of the board of directors under stock option plans and the employee stock purchase plan is
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Cost of sales |
|
$ |
|
|
|
$ |
1 |
|
|
$ |
|
|
|
$ |
2 |
|
Selling, general and administrative |
|
|
859 |
|
|
|
292 |
|
|
|
2,502 |
|
|
|
697 |
|
Research and development |
|
|
286 |
|
|
|
62 |
|
|
|
520 |
|
|
|
129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,145 |
|
|
$ |
355 |
|
|
$ |
3,022 |
|
|
$ |
828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation cost related to stock options granted to employees and non-employee
members of the board of directors is recognized as an expense, net of estimated pre-vesting
forfeitures, ratably over the vesting period of the award. The Company has estimated an annual
pre-vesting forfeiture rate of 12% for a typical stock award with a four year vesting term. The
pre-vesting forfeiture rate was estimated based on historical data.
The fair value of stock options awarded to employees and non-employee members of the Companys
board of directors was estimated using the Black-Scholes option valuation model. Expected
volatility is based on the historical volatility of the Companys stock. The expected term for the
three and six month periods ended June 30, 2008 is based on the Companys historical term of its
stock option awards. The expected term for the three and six month periods ended June 30, 2007 was
estimated using the simplified method described in Staff Accounting Bulletin No. 107 issued by the
Securities and Exchange Commission. The expected term represents the estimated period of time that
stock options granted are expected to be outstanding. The risk-free interest rate is based on the
U.S. Treasury yield curve. The expected dividend yield is zero, as the Company does not anticipate
paying dividends in the near future. The weighted average assumptions are as follows:
7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Expected volatility |
|
|
86 |
% |
|
|
84 |
% |
|
|
86 |
% |
|
|
84-86 |
% |
Weighted average volatility |
|
|
86 |
% |
|
|
84 |
% |
|
|
86 |
% |
|
|
86 |
% |
Expected term (in years) |
|
|
4.4 |
|
|
|
6.25 |
|
|
|
4.4 |
|
|
|
6.25 |
|
Risk-free interest rate |
|
|
3.2 |
% |
|
|
4.9 |
% |
|
|
2.1-3.2 |
% |
|
|
4.6-4.9 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of the stock options granted to employees and
non-employee members of the Companys board of directors was $3.43 and $0.49 during the three month
periods ended June 30, 2008 and 2007, respectively, and $3.36 and $0.98 during the six month
periods ended June 30, 2008 and 2007, respectively.
The Company utilized the Black-Scholes option valuation model in connection with determining
the fair value of each option element of the Companys Employee Stock Purchase Plan. Expected
volatility is based on historical volatility of the Companys common stock. The expected term
represents the life of the option element. The risk-free interest rate is based on the U.S.
Treasury yield. The expected dividend yield is zero, as the Company does not anticipate paying
dividends in the near future. The weighted average assumptions are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Expected volatility |
|
|
81 |
% |
|
|
70 |
% |
|
|
78-81 |
% |
|
|
65-70 |
% |
Weighted average volatility |
|
|
81 |
% |
|
|
70 |
% |
|
|
78-81 |
% |
|
|
67 |
% |
Expected term (in years) |
|
|
0.69 |
|
|
|
0.71 |
|
|
|
0.30-0.69 |
|
|
|
0.53-0.71 |
|
Risk-free interest rate |
|
|
2.8 |
% |
|
|
5.0 |
% |
|
|
2.4 |
% |
|
|
5.0 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted average fair value of each option element under the Companys Employee Stock
Purchase Plan was $3.55 and $0.47 for the three month periods ended June 30, 2008 and 2007,
respectively, and $3.59 and $0.42 for the six month periods ended June 30, 2008 and 2007,
respectively.
3. REVENUE RECOGNITION
During July 2007, the Company began utilizing CuraScript, a third party specialty distributor,
to store and distribute Acthar. Effective August 1, 2007, the Company no longer sells Acthar to
wholesalers and all of the Companys proceeds from sales of Acthar in the United States are
received from CuraScript. The Company sells Acthar to CuraScript at a discount from the Companys
list price. CuraScript sells Acthar primarily to hospitals and specialty pharmacies. Product sales
are recognized net of this discount upon receipt of the product by CuraScript. In April 2008, the
Company revised its agreement with CuraScript, as discussed further in Note 13. The Company sells
Doral to wholesalers, who in turn sell Doral primarily to retail pharmacies and hospitals. The
Company does not require collateral from its customers. Revenues from product sales are recognized
based upon shipping terms, net of estimated reserves for government chargebacks, Medicaid rebates,
payment discounts and returns for credit. Revenue is recognized upon customer receipt of the
shipment, provided that title to the product transfers at the point of receipt by the customer. If
the title to the product transfers at the point of shipment, revenue is recognized upon shipment of
the product.
The Company will supply replacement product to CuraScript on product returned between one
month prior to expiration to three months post expiration. Returns from product lots will be
exchanged for replacement product, and estimated costs for such exchanges, which include actual
product material costs and related shipping charges, are included in cost of sales. A reserve for
estimated future replacements has been recorded as a liability within sales-related reserves which
will be reduced as future replacements occur, with an offset to product inventories. The Company
issues credit memoranda or reimburses wholesalers or their customers for product sold to the
wholesaler that is returned within six months beyond the expiration date. The credit memoranda or
reimbursement is equal to the sales value of the product returned and the estimated amount of such
obligation is recorded as a liability within sales-related reserves with a corresponding reduction
in gross product sales. This liability is reduced as the obligation is satisfied, with an offset to
accounts receivable. Returns are subject to inspection prior to acceptance. The Company records
estimated sales reserves based primarily upon historical return rates by product, analysis of
return merchandise authorizations and returns received. The Company also considers sales patterns,
current inventory on hand at wholesalers, and other factors such as shelf life.
The Company provides a rebate related to product dispensed to Medicaid eligible patients. The
Companys estimated historical rebate percentage is used to estimate the rebate units associated
with product shipped during a period. The Company then applies a rebate amount per unit to the
estimated rebate units to arrive at the estimated reserve for the period. The estimated liability
included in
8
sales-related reserves as of the end of a period is comprised of the estimated rebate units
associated with estimated end user demand during the period, the estimated rebate units associated
with estimated inventory in the distribution channel as of the end of the period, and the estimated
rebate units, if any, associated with prior rebate periods. The rebate amount per unit is
determined based on a formula established by statute that is subject to review and modification by
the administrators of the Medicaid program. The rebate per unit formula is comprised of a basic
rebate of 15.1% applied to the average per unit amount of payments the Company receives on its
product sales and an additional per unit rebate that is based on the Companys current sales price
compared to its sales price on an inflation adjusted basis from a designated base period.
Certain government entities are permitted to purchase the Companys products for a nominal
amount from wholesalers and CuraScript. The wholesalers and CuraScript charge the significant
discount back to the Company and reduce subsequent payment to the Company by the amount of the
approved chargeback. The chargeback approximates the Companys sales price to its customers. As a
result, the Company recognizes nominal, if any, net sales on shipments that qualify for the
government chargeback. The reduction to gross sales for a period related to chargebacks is
comprised of actual approved chargebacks originating during the period and an estimate of
chargebacks in the ending inventory of the Companys customers. In estimating the government
chargeback reserve as of the end of a period, the Company estimates the amount of chargebacks in
its customers ending inventory using actual average monthly chargeback amounts and ending
inventory balances provided by the Companys largest customers.
Significant judgment is inherent in the selection of assumptions and in the interpretation of
historical experience as well as the identification of external and internal factors affecting the
estimate of reserves for product returns, Medicaid rebates and government chargebacks. The Company
routinely assesses the historical returns and other experience including customers compliance with
its return goods policy and changes its reserve estimates as appropriate.
At June 30, 2008 and December 31, 2007, sales-related reserves included in the accompanying
Consolidated Balance Sheets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Product returns credit memoranda policy |
|
$ |
672 |
|
|
$ |
1,307 |
|
Product returns product replacement policy |
|
|
51 |
|
|
|
31 |
|
Medicaid rebates |
|
|
11,506 |
|
|
|
6,514 |
|
Government chargebacks |
|
|
71 |
|
|
|
222 |
|
Other |
|
|
102 |
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
$ |
12,402 |
|
|
$ |
8,176 |
|
|
|
|
|
|
|
|
4. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
The Company considers highly liquid investments with maturities from the date of purchase of
three months or less to be cash equivalents. The Company had cash, cash equivalents and short-term
investments of $38.9 million and $30.2 million at June 30, 2008 and December 31, 2007,
respectively. Cash equivalents are invested in money market funds and commercial paper. Short-term
investments are invested in commercial paper and government-sponsored enterprises and have an
average contractual maturity of approximately 6 months as of June 30, 2008. The fair value of the
funds approximated their cost.
Effective January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements (SFAS
No. 157). SFAS No. 157 applies to all fair measurements not otherwise specified in an existing
standard, clarifies how to measure fair value, and expands fair value disclosures. SFAS No. 157
does not significantly change the Companys previous practice with regard to asset valuation. All
of the Companys fair market value measurements utilize quoted prices in active markets for all its
short-term investments, and are as a result valued at the Level 1 fair value hierarchy as defined
in SFAS No. 157.
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, |
|
|
|
2008 |
|
|
2007 |
|
Raw materials |
|
$ |
1,928 |
|
|
$ |
1,987 |
|
Work in process |
|
|
427 |
|
|
|
|
|
Finished goods |
|
|
107 |
|
|
|
387 |
|
Less allowance for excess and obsolete inventories |
|
|
(16 |
) |
|
|
(9 |
) |
|
|
|
|
|
|
|
|
|
$ |
2,446 |
|
|
$ |
2,365 |
|
|
|
|
|
|
|
|
9
6. PURCHASED TECHNOLOGY
Purchased technology at June 30, 2008 consists of the Companys acquisition costs related to
the May 2006 acquisition of the Doral product rights and a cash payment of $300,000 to IVAX
Research, Inc. made in January 2007 to eliminate the Doral royalty obligation. The purchased
technology is being amortized on a straight-line basis over Dorals expected life of 15 years.
Accumulated amortization for the Doral purchased technology was $567,000 as of June 30, 2008.
7. COMMITMENTS, INDEMNIFICATIONS AND CONTINGENCIES
The Company leases a 30,000 square foot facility in Hayward, California. The Companys master
lease on the Hayward facility expires in November 2012. Effective November 1, 2007, the Company
subleased 5,000 square feet of the facility through April 2009 and effective February 1, 2008 the
Company subleased the remaining 25,000 square feet through the remainder of the term of the master
lease. These subleases cover a portion of the Companys lease commitment and all of its insurance,
taxes and common area maintenance. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the accompanying
Consolidated Statements of Operations. As of June 30, 2008, the Company is obligated to pay rent on
the Hayward facility of $3.8 million. Over the remaining term of the master lease the Company
anticipates that it will receive approximately $1.7 million in sublease income to be used to pay a
portion of its Hayward facility obligation. As of June 30, 2008 and December 31, 2007, the
estimated liability related to the Hayward facility totaled $1.4 million and $1.6 million,
respectively, and is included in Lease Termination and Deferred Rent Liabilities in the
accompanying Consolidated Balance Sheets. The fair value of the liability was determined using a
credit-adjusted risk-free rate to discount the estimated future net cash flows, consisting of the
minimum lease payments under the master lease, net of estimated sublease rental income that could
reasonably be obtained from the property. The Company is also required to recognize an on-going
accretion expense representing the difference between the undiscounted net cash flows and the
discounted net cash flows over the remaining term of the Hayward master lease using the interest
method. The accretion amount represents an on-going adjustment to the estimated liability. The
Company reviews the assumptions used in determining the estimated liability quarterly and revises
its estimate of the liability to reflect changes in circumstances.
The Company, as permitted under California law and in accordance with its Bylaws, indemnifies
its officers and directors for certain events or occurrences while the officer or director is or
was serving at the Companys request in such capacity. The potential future indemnification limit
is to the fullest extent permissible under California law; however, the Company has a director and
officer insurance policy that limits its exposure and may enable it to recover a portion of any
future amounts paid. The Company believes the fair value of these indemnification agreements is
minimal. Accordingly, the Company has no liabilities recorded for these agreements as of June 30,
2008 and December 31, 2007.
The Company has entered into employment agreements with its corporate officers that provide
for, among other things, base compensation and/or other benefits in certain circumstances in the
event of termination or a change in control. In addition, certain of the agreements provide for the
accelerated vesting of outstanding unvested stock options upon a change in control.
From time to time, the Company may become involved in claims and other legal matters arising
in the ordinary course of business. 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
8. NET INCOME (LOSS) PER SHARE
Basic net income (loss) per share is computed using the two-class method. Under the two-class
method, undistributed net income is allocated to common stock and participating securities based on
their respective rights to share in dividends. The Companys Series A Preferred Stock was a
participating security for periods prior to its repurchase on February 19, 2008 (see Note 11). Net
loss has not been allocated to the Series A preferred stockholder for the three and six month
periods ended June 30, 2007 as the Series A preferred stockholder did not have a contractual
obligation to share in the losses of the Company. For basic net income (loss) per share applicable
to common shareholders, net income (loss) applicable to common shareholders is divided by the
weighted average common shares outstanding during the period. Diluted net income per share gives
effect to all potentially dilutive common shares outstanding during the period such as options,
warrants, convertible preferred stock, and contingently issuable shares.
The following table presents the amounts used in computing basic and diluted net income (loss)
per share applicable to common shareholders for the three and six month periods ended June 30, 2008
and 2007, and the effect of dilutive potential common shares on the number of shares used in
computing basic net income (loss) per share applicable to common shareholders. Diluted potential
common shares resulting from the assumed exercise of outstanding stock options and warrants are
determined based on the treasury stock method (in thousands, except per share amounts).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income (loss) applicable to common shareholders |
|
$ |
8,794 |
|
|
$ |
(1,717 |
) |
|
$ |
10,068 |
|
|
$ |
(5,476 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net income (loss) per share
applicable to common shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
69,205 |
|
|
|
68,989 |
|
|
|
69,576 |
|
|
|
68,882 |
|
Effect of dilutive potential common shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
3,471 |
|
|
|
|
|
|
|
3,622 |
|
|
|
|
|
Warrants |
|
|
194 |
|
|
|
|
|
|
|
273 |
|
|
|
|
|
Restricted stock |
|
|
19 |
|
|
|
|
|
|
|
25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
72,889 |
|
|
|
68,989 |
|
|
|
73,496 |
|
|
|
68,882 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share applicable to common shareholders: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.13 |
|
|
$ |
(0.02 |
) |
|
$ |
0.14 |
|
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
$ |
0.12 |
|
|
$ |
(0.02 |
) |
|
$ |
0.14 |
|
|
$ |
(0.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The computation of diluted net income per share applicable to common shareholders for the
three month period ended June 30, 2008 excluded the effect of 1,285,500 options to purchase common
shares and 233,296 shares of unvested restricted stock as the inclusion of these securities would
have been anti-dilutive. The computation of diluted net income per share applicable to common
shareholders for the six month period ended June 30, 2008 excluded the effect of 1,206,250 options
to purchase common shares, 233,296 shares of unvested restricted stock and 2,155,715 shares of
Series A Preferred Stock as the inclusion of these securities would have been anti-dilutive.
Diluted net loss per share has not been computed for the three and six month periods ended June 30,
2007 as, due to the Companys net loss position, it would have been anti-dilutive.
9. INCOME TAXES
The Company makes certain estimates and judgments in determining income tax expense for
financial statement purposes. These estimates and judgments occur in the calculation of certain tax
assets and liabilities, which arise from differences in the timing of recognition of revenue and
expense for tax and financial statement purposes.
As part of the process of preparing its consolidated financial statements, the Company is
required to estimate its income taxes in each of the jurisdictions in which it operates. This
process involves estimating current tax exposure under the most recent tax laws and assessing
temporary differences resulting from differing treatment of items for tax and accounting purposes.
These differences result in deferred tax assets and liabilities, which are included in the
Companys consolidated balance sheets.
Income tax expense for the three and six month periods ended June 30, 2008 was $5.6 million
and $10.1 million, respectively. For the three and six month periods ended June 30, 2008, the
Companys effective tax rate for financial reporting purposes was approximately 39 percent and 40
percent, respectively. The Companys second quarter and year to date tax expense for financial
reporting purposes includes the benefit of the reversal of a valuation allowance associated with a
federal net operating loss carry forward available to the Company in 2009 of approximately
$750,000. During the second quarter of 2008, the Company determined, based on taxable income for
the six month period ended June 30, 2008 and anticipated income for 2008 and 2009, that it is more
likely than not that these deferred tax assets would be realized. The tax benefit resulting from
the reversal of the valuation reserve
11
was partially offset by the impact of the difference for financial reporting and tax purposes
of deductions associated with stock-based compensation. Actual tax payments related to 2008 are
expected to be paid at a rate of approximately 18 percent, as the Company has access to $29.4
million and $17.4 million of federal and state operating loss carryforwards, respectively, and
$157,000 and $180,000 of the federal and California research and development credits, respectively,
to reduce its 2008 taxable income. The Company has made estimated tax payments of $3.8 million for
the six months ended June 30, 2008 associated with its estimated 2008 tax obligations. There was
no income tax expense for the three and six month periods ended June 30, 2007 as the Company
incurred a net loss of $1.7 million and $5.5 million, respectively.
10. COMPREHENSIVE INCOME (LOSS)
Comprehensive income (loss) is comprised of net income (loss) and the change in unrealized
holding gains and losses on available-for-sale securities (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income (loss) |
|
$ |
8,794 |
|
|
$ |
(1,717 |
) |
|
$ |
10,068 |
|
|
$ |
(5,476 |
) |
Change in unrealized gains on available-for-sale securities |
|
|
(62 |
) |
|
|
5 |
|
|
|
(37 |
) |
|
|
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
8,732 |
|
|
$ |
(1,712 |
) |
|
$ |
10,031 |
|
|
$ |
(5,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
11. EQUITY TRANSACTIONS
On February 19, 2008, the Company repurchased all of the outstanding 2,155,715 shares of
Series A Preferred Stock from Shire Pharmaceuticals, Inc. for cash consideration of $10.3 million
or $4.80 per share, the same price per preferred share as the closing price per share of the
Companys common stock on February 19, 2008. The Series A Preferred Stock had a carrying value of
$5.1 million. The $5.2 million difference between the $10.3 million repurchase payment and the $5.1
million balance sheet carrying value was accounted for as a deemed dividend and reduced the
Companys net income in the determination of net income applicable to common shareholders in the
accompanying Consolidated Statement of Operations.
On February 29, 2008, the Companys board of directors approved a stock repurchase plan that
provides for the Companys repurchase of up to 7 million of its common shares. Stock repurchases
under this program may be made through either open market or privately negotiated transactions in
accordance with all applicable laws, rules and regulations. Through June 30, 2008, the Company had
repurchased 2,740,900 common shares for $11.8 million. In July 2008 the Company repurchased an
additional 587,000 shares of its common stock under its stock repurchase plan for $2.9 million. To
date, the Company has repurchased a total of 3,327,900 shares of its common stock for $14.7 million
under this plan. In addition, on August 13, 2008, the
Company completed a board-approved repurchase of
2,200,000 shares of its common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal
L.D.A, an entity owned by Paolo Cavazza and members of his family, for $10.9 million or $4.95 per
share. This repurchase was made outside of the Companys existing share repurchase plan.
On February 29, 2008, the Companys board of directors approved a reduction in the offering
period of the Employee Stock Purchase Plan (ESPP) from 12 months to 3 months effective with the
next offering period that begins on September 1, 2008, eliminated the ability of plan participants
to increase their contribution levels during an offering period and
approved an amendment authorizing the addition of
500,000 shares to the ESPP. In addition, the Companys board of directors approved an amendment on
April 16, 2008, to permanently reduce the maximum offering period available from 27 months to 6
months and to permanently remove the ability of ESPP participants to increase their contributions
during an offering period. These amendments to the ESPP were approved
by shareholders at the Companys annual
shareholders meeting on May 29, 2008.
During the three months ended June 30, 2008, 348,227 shares of the Companys common stock were
issued upon the cashless net exercise of 475,248 warrants. As of June 30, 2008, the Company no
longer has any warrants outstanding.
12. RECENTLY ISSUED ACCOUNTING STANDARDS
In April 2008, the FASB issued FSP FAS No.142-3, Determination of the Useful Life of
Intangible Assets (FSP FAS No. 142-3). In determining the useful life of intangible assets, FSP
FAS No. 142-3 removes the requirement to consider whether an intangible asset can be renewed
without substantial cost of material modifications to the existing terms and conditions and,
instead, requires an entity to consider its own historical experience in renewing similar
arrangements. FSP FAS No. 142-3 also requires expanded disclosure related to the determination of
intangible asset useful lives. FSP FAS No. 142-3 is effective for financial statements issued
12
for fiscal years beginning after December 15, 2008. The Company does not expect that the
adoption of FSP FAS No. 142-3 will have a material impact on its financial position and results of
operations.
In February 2008, the FASB issued FASB Staff Position No. FAS 157-2, Effective Date of FASB
Statement No. 157 (FSP FAS No. 157-2), which defers the effective date of SFAS No. 157 for all
non-financial assets and non-financial liabilities, except those that are recognized or disclosed
at fair value in the financial statements on a recurring basis (at least annually), for fiscal
years beginning after November 15, 2008 and interim periods within those fiscal years for items
within the scope of FSP FAS No. 157-2. The Company does not expect that the adoption of FSP FAS No.
157-2 will have a material impact on its financial position and results of operations.
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations (SFAS No. 141(R)),
which replaces FAS No. 141. SFAS No. 141(R) establishes principles and requirements for how an
acquirer in a business combination recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, and any controlling interest; recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain purchase; and
determines what information to disclose to enable users of the financial statements to evaluate the
nature and financial effects of the business combination. SFAS No. 141(R) is to be applied
prospectively to business combinations for which the acquisition date is on or after an entitys
fiscal year that begins after December 15, 2008. The Company will assess the impact of SFAS No.
141(R) if and when a future acquisition occurs.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS No. 160). SFAS No. 160 establishes new
accounting and reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the recognition of a
noncontrolling interest (minority interest) as equity in the consolidated financial statements and
separate from the parents equity. The amount of net income attributable to the noncontrolling
interest will be included in consolidated net income on the face of the income statement. SFAS No.
160 clarifies that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains its controlling financial interest.
In addition, this statement requires that a parent recognize a gain or loss in net income when a
subsidiary is deconsolidated. Such gain or loss will be measured using the fair value of the
noncontrolling equity investment on the deconsolidation date. SFAS No. 160 also includes expanded
disclosure requirements regarding the interests of the parent and its noncontrolling interest. SFAS
No. 160 is effective for fiscal years, and interim periods within those fiscal years, beginning on
or after December 15, 2008. Earlier adoption is prohibited. The Company does not expect that the
adoption of SFAS No. 160 will have a material impact on the Companys financial position and
results of operations.
In November 2007, the EITF issued EITF Issue No. 07-1, Accounting for Collaborative
Arrangements Related to the Development and Commercialization of Intellectual Property (EITF
07-1). Companies may enter into arrangements with other companies to jointly develop, manufacture,
distribute, and market a product. Often the activities associated with these arrangements are
conducted by the collaborators without the creation of a separate legal entity (that is, the
arrangement is operated as a virtual joint venture). The arrangements generally provide that the
collaborators will share, based on contractually defined calculations, the profits or losses from
the associated activities. Periodically, the collaborators share financial information related to
product revenues generated (if any) and costs incurred that may trigger a sharing payment for the
combined profits or losses. The consensus requires collaborators in such an arrangement to present
the result of activities for which they act as the principal on a gross basis and report any
payments received from (made to) other collaborators based on other applicable GAAP or, in the
absence of other applicable GAAP, based on analogy to authoritative accounting literature or a
reasonable, rational, and consistently applied accounting policy election. EITF 07-1 is effective
for collaborative arrangements in place at the beginning of the annual period beginning after
December 15, 2008. The Company does not expect that the adoption of EITF 07-1 will have a material
impact on the Companys financial position and results of operations.
13. DISTRIBUTION AGREEMENT
On April 18, 2008, the Company amended its distribution agreement with CuraScript, its U.S.
distributor for H.P. Acthar Gel. The amendment became effective on June 1, 2008. Under the new
terms, the discount provided by the Company to CuraScript is reduced from $1,047 per vial to $230
per vial. The new discounted sales price to CuraScript is $23,039 per vial and the stated list
price remains at $23,269 per vial. Under the new terms the pricing to CuraScript customers is
unchanged. The amount of the discount to CuraScript is subject to annual adjustments based on the
Consumer Price Index. In addition, the payment terms have been reduced from 60 days to 30 days.
13
14. SUBSEQUENT EVENTS
From July 1, 2008 through July 25, 2008, the Company repurchased 587,000 shares of its common
stock for $2.9 million under its stock repurchase program approved by the Companys board of
directors in February 2008. To date, the Company has repurchased a total of 3,327,900 shares of its
common stock for $14.7 million under this plan. In addition, on
August 13, 2008, the Company
completed a board-approved repurchase of 2,200,000 shares of its common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal L.D.A, an entity owned by Paolo Cavazza and members of his
family, for $10.9 million or $4.95 per share. This repurchase was made outside of the Companys
existing share repurchase plan.
On July 31, 2008, the Company entered into a transition arrangement with Mr. George Stuart,
the Companys Senior Vice President of Finance and Chief Financial Officer. Mr. Stuart resides in
Southern California and has been commuting to the Companys location in Northern California for the
past three years. Mr. Stuart desires to remain in Southern California. As a result, Mr. Stuart
will continue in his current role until the Company locates a new Chief Financial Officer and then
provide part-time services to the Company for 6 months to assist with the transition.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Except for the historical information contained herein, the following discussion contains
forward-looking statements that involve risks and uncertainties. Our actual results could differ
materially from those discussed herein. Factors that could cause or contribute to such differences
include, but are not limited to, those discussed in this section, as well as those discussed in our
Annual Report on Form 10-K for the year ended December 31, 2007, including Item 1 Business of
Questcor, and Item 1A Risk Factors, as well as factors discussed in any documents incorporated
by reference herein or therein. Whenever used in this Quarterly Report, the terms Questcor,
Company, we, our, ours, and us refer to Questcor Pharmaceuticals, Inc. and its
consolidated subsidiary.
Overview
We currently market two commercial products, H.P. Acthar Gel (repository corticotropin
injection) and Doral (quazepam). H.P. Acthar Gel (Acthar) is an injectable drug that is approved
for the treatment of certain disorders with an inflammatory component, including the treatment of
exacerbations associated with multiple sclerosis (MS). In addition, Acthar is not indicated for,
but is used in treating patients with infantile spasms (IS), a rare form of refractory childhood
epilepsy, and opsoclonus myoclonus syndrome, a rare autoimmune-related childhood neurological
disorder. Doral is indicated for the treatment of insomnia characterized by difficulty in falling
asleep, frequent nocturnal awakenings, and/or early morning awakenings. We are also developing
QSC-001, a unique orally disintegrating tablet formulation of hydrocodone bitartrate and
acetaminophen for the treatment of moderate to moderately severe pain in patients with swallowing
difficulties.
In August 2007, we announced our Acthar-centric business strategy. In connection with the new
strategy, we implemented a new pricing level for Acthar which was effective August 27, 2007. We
also expanded our sponsorship of Acthar patient assistance and co-pay assistance programs, which
provide an important safety net for uninsured and under-insured patients using Acthar, and
established a group of product service consultants and medical science liaisons to work with
healthcare providers who administer Acthar. As a result, we are not aware of a single patient who
needs Acthar but has not been able to access it. This was not the case before our strategy change.
Because we are now economically viable, we have significantly improved our ability to maintain the
long-term availability of Acthar and fund important medical research projects that
have the goal of improving patient care. We have been working closely with the neurology community
to identify promising new projects for which we can provide needed financial support. We are
providing support to leading researchers in their efforts to better understand the underlying
disease processes that cause infantile spasms, a subject for which there has been little research
funding in recent decades. We are also in discussions with experts in other disease states with
high unmet medical needs for which there is a potential therapeutic role for Acthar.
Acthar is currently approved in the U.S. for the treatment of exacerbations associated with MS
and many other conditions with an inflammatory component. No drug is approved in the U.S. for the
treatment of IS, a potentially life-threatening disorder that typically begins in the first year of
life. However, pursuant to guidelines published by the American Academy of Neurology and the Child
Neurology Society, many child neurologists use Acthar to treat infants afflicted with IS. In June
2006, we submitted a Supplemental New Drug Application (sNDA) to the FDA and are currently
pursuing formal agency approval of an indication for the use of Acthar in the treatment of IS. In
May 2007, we received an action letter from the FDA indicating that our sNDA was not approvable in
its current form. In November 2007, we met with the FDA to further discuss our sNDA. At the
meeting, the FDA concurred with our
14
suggested pathway to resubmit the application with additional information. Our efforts are
focused on two major projects involving the compilation and analysis of efficacy data from prior,
randomized controlled trials and safety data from prior studies as well as historical patient
records. Our goal is to submit the additional information to the FDA by the end of 2008. At this
time, the FDA is not requiring us to conduct a clinical trial to support our resubmission.
Our strategy is to focus on growth initiatives for Acthar, continue the development of
QSC-001, improve operational efficiencies, and return cash to shareholders through repurchases of
our common stock. Our most important growth initiative is the planned 2008 resubmission to the FDA
of the sNDA in support of a new indication for IS. Should the FDA grant approval for this
indication, we could then begin promoting the use of Acthar in this indication, something we are
presently prohibited from doing. We believe that such promotion has the potential to increase usage
of Acthar in IS beyond current levels. We are also currently working on a number of initiatives
aimed at developing future growth opportunities for Acthar in therapeutic areas other than IS.
These include in-depth evaluation of uses that are currently a part of Acthars extensive list of
on-label indications. For example, we have observed some continued usage, as well as favorable
insurance coverage, in the subset of MS patients who do not respond to, or who cannot tolerate, IV
corticosteroids, the first-line treatment of most neurologists for MS flares. Market research
indicates that many MS flare patients may be in this subset. In response, we have modestly
increased our promotional efforts directed to MS specialists to further explore the potential of
this opportunity in the coming months. We are also looking at other indications that could provide
additional patient benefits and sales growth potential for Acthar.
The August 2007 implementation of our Acthar-centric business strategy fundamentally changed
the nature of Questcor and the success of that strategy to date has resulted in significantly
improved financial results for the three and six month periods ended June 30, 2008 as compared to
the corresponding periods in the prior year. Our results of operations may vary significantly from
quarter to quarter depending on, among other factors, demand for our products by patients,
inventory levels of our products held by third parties, amount of Medicaid rebates on our products
dispensed to Medicaid eligible patients, the amount of chargebacks on the sale of our products by
our specialty distributor to government entities, the availability of finished goods from our
sole-source manufacturers, the timing of certain expenses, the timing and amount of our product
development expenses, and our ability to develop growth opportunities for Acthar.
On May 5, 2008, we announced that our board of directors approved the decision to switch the
listing of our common stock from the American Stock Exchange to the NASDAQ Stock Market LLC.
Effective May 16, 2008, we commenced trading on NASDAQ under the trading symbol QCOR.
Critical Accounting Policies
Our managements discussion and analysis of our financial condition and results of operations
is based upon our consolidated financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of these financial statements
requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosures. On an on-going basis, we evaluate our
estimates, including those related to our Medicaid rebate obligation related to our products
dispensed to Medicaid eligible patients, chargebacks on sales of our products by wholesalers and
our specialty distributor to government entities, product returns, bad debts, inventories,
intangible assets, share-based compensation, lease termination liability and income taxes. We base
our estimates on historical experience and on various other assumptions that we believe are
reasonable under the circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different assumptions or conditions. We
believe the following critical accounting policies affect our more significant judgments and
estimates used in the preparation of our consolidated financial statements.
Sales Reserves
For the three and six month periods ended June 30, 2008 and 2007, we have estimated reserves
for product returns from our specialty distributor, wholesalers, hospitals and pharmacies;
government chargebacks for sales of our products by wholesalers and our specialty distributor to
certain Federal government organizations including the Veterans Administration; Medicaid rebates to
all states for products dispensed to patients covered by Medicaid; and cash discounts for prompt
payment on our sales of Doral. We estimate our reserves by utilizing historical information for our
existing products and data obtained from external sources.
Significant judgment is inherent in the selection of assumptions and the interpretation of
historical experience as well as the identification of external and internal factors affecting the
estimates of our reserves for product returns, 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 returns, government
chargebacks, and Medicaid rebates could differ significantly from our estimates because our
analysis of product shipments, prescription trends, the amount of product in the
15
distribution channel, and our interpretation of the Medicaid statute and regulations, may not
be accurate. If actual product returns, government chargebacks, and Medicaid rebates are
significantly different from our estimates, or if our customers fail to adhere to our expired
product returns policy, such differences would be accounted for in the period in which they become
known. To date, actual amounts have been consistent with our estimates.
During July 2007, we began utilizing CuraScript, a third party specialty distributor, to store
and distribute Acthar. Effective August 1, 2007, we no longer sell Acthar to wholesalers and all of
our proceeds from sales of Acthar in the United States are received from CuraScript. We sell Acthar
to CuraScript at a discount from our list price. Product sales are recognized net of this discount
upon receipt of the product by CuraScript. In April 2008, we announced the amendment to our
distribution agreement with CuraScript, which became effective on June 1, 2008. Under the new
terms, the discount provided by us to CuraScript is reduced from $1,047 per vial to $230 per vial.
The new discounted sales price to CuraScript is $23,039 per vial and the stated list price remains
at $23,269. However, under the new terms the pricing to CuraScript customers is unchanged. The
amount of the discount to CuraScript is subject to annual adjustments based on the Consumer Price
Index. In addition, the payment terms have been reduced from 60 days to 30 days from when product
is received by CuraScript. We will supply replacement product to CuraScript on product returned
between one month prior to expiration to three months post expiration. Returns from product lots
will be exchanged for replacement product, and estimated costs for such exchanges, which include
actual product material costs and related shipping charges, are included in cost of sales. A
reserve for estimated future replacements has been recorded as a liability within sales-related
reserves which will be reduced as future replacements occur, with an offset to product inventories.
We issue credit memoranda or reimburse wholesalers or their customers for product sold to
wholesalers that is returned within six months beyond the expiration date. The credit memoranda or
reimbursement is equal to the sales value of the product returned and the estimated amount of such
obligation is recorded as a liability within sales-related reserves with a corresponding reduction
in gross product sales. This liability is reduced as the obligation is satisfied, with an offset to
accounts receivable. In estimating the return rate for expired product returned by wholesalers and
their customers, we primarily analyze historical returns by product and return merchandise
authorizations. We also consider current inventory on hand at wholesalers, the remaining shelf life
of that inventory, and changes in demand measured by prescriptions or other data as provided by an
independent third party source. We believe that the information obtained from wholesalers regarding
inventory levels and from independent third parties regarding prescription demand is reliable, but
we are unable to independently verify the accuracy of such data. We routinely assess our historical
experience including customers compliance with our product return policy, and we change our
reserve estimates as appropriate. The reserve for the sales value of expired product expected to be
returned by wholesalers and their customers relates to estimated returns associated with our sales
of Doral and our estimate of returns associated with sales of Acthar to wholesalers prior to our
transition to CuraScript.
We provide a rebate related to product dispensed to Medicaid eligible patients. Our estimated
historical rebate percentage is used to estimate the rebate units associated with product shipped
during a period. We then apply a rebate amount per unit to the estimated rebate units to arrive at
the estimated reserve for the period. The estimated liability included in sales-related reserves as
of the end of a period is comprised of the estimated rebate units associated with estimated end
user demand during the period, the estimated rebate units associated with estimated inventory in
the distribution channel as of the end of the period, and the estimated rebate units, if any,
associated with prior rebate periods. The rebate amount per unit is determined based on a formula
established by statute and is subject to review and modification by the administrators of the
Medicaid program. The rebate per unit formula is comprised of a basic rebate of 15.1% applied to
the average per unit amount of payments we receive on our product sales and an additional per unit
rebate that is based on our current sales price compared to our sales price on an inflation
adjusted basis from a designated base period.
Certain government entities are permitted to purchase our products for a nominal amount from
wholesalers and CuraScript. The wholesalers and CuraScript charge the significant discount back to
us and reduce subsequent payment to us by the amount of the approved chargeback. The chargeback
approximates our sales price to our customers. As a result, we recognize nominal, if any, net sales
on shipments to these entities that qualify for the government chargeback. The reduction to gross
sales for a period related to chargebacks is comprised of actual approved chargebacks originating
during the period and an estimate of chargebacks in the ending inventory of our customers. In
estimating the government chargeback reserve as of the end of a period, we estimate the amount of
chargebacks in our customers ending inventory using actual average monthly chargeback amounts and
ending inventory balances provided by our largest customers.
We routinely assess our experience with Medicaid rebates and government chargebacks and change
the reserve estimates as appropriate. For sales of Doral, we grant payment terms of 2%, net 30
days. Allowances for cash discounts are recorded as a reduction to trade accounts receivable and
are estimated based upon the amount of trade accounts receivable subject to the cash discounts.
At June 30, 2008 and December 31, 2007, sales-related reserves included in the accompanying
Consolidated Balance Sheets were as follows (in thousands):
16
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2008 |
|
|
2007 |
|
Product returns credit memoranda policy |
|
$ |
672 |
|
|
$ |
1,307 |
|
Product returns product replacement policy |
|
|
51 |
|
|
|
31 |
|
Medicaid rebates |
|
|
11,506 |
|
|
|
6,514 |
|
Government chargebacks |
|
|
71 |
|
|
|
222 |
|
Other |
|
|
102 |
|
|
|
102 |
|
|
|
|
|
|
|
|
|
|
$ |
12,402 |
|
|
$ |
8,176 |
|
|
|
|
|
|
|
|
Inventories
As of June 30, 2008, our net raw material, work in process and finished goods inventories
totaled $2.4 million. We maintain inventory reserves primarily for excess and obsolete inventory
(due to the expiration of shelf life of a product). In estimating inventory excess and obsolescence
reserves, we analyze (i) the expiration date, (ii) our sales forecasts and (iii) historical demand.
Judgment is required in determining whether the forecasted sales information is sufficiently
reliable to enable us to reasonably estimate excess and obsolete inventory. If actual future usage
and demand for our products is less favorable than projected, additional inventory write-offs may
be required in the future which would increase our cost of sales in the period of any write-offs.
We intend to control inventory levels of our products purchased by our customers. Customer
inventories may be compared to both internal and external databases to determine adequate inventory
levels. We may monitor our product shipments to customers and compare these shipments against
prescription demand for our individual products.
Intangible and Long-Lived Assets
As of June 30, 2008, our intangible and long-lived assets consisted of goodwill of $299,000
generated from a merger in 1999, net purchased technology of $3.8 million related to our
acquisition of Doral and $443,000 of net property and equipment. The determination of whether or
not our intangible and long-lived assets are impaired and the expected useful lives of purchased
technology involves significant judgment. Changes in strategy or market conditions could
significantly impact these judgments and require a write-down of our recorded asset balances and a
reduction in the expected useful life of our purchased technology. Such a write-down of our
recorded asset balances or reduction in the expected useful life of our purchased technology would
increase our operating expenses. In accordance with SFAS No. 142, Goodwill and Other Intangible
Assets, we review goodwill for impairment on an annual basis. Our fair value is compared to the
carrying value of our net assets, including goodwill. If the fair value is greater than the
carrying amount, then no impairment is indicated. In accordance with SFAS No. 144, Accounting for
the Impairment or Disposal of Long-Lived Assets, we review long-lived assets, consisting of
property and equipment and purchased technology, for impairment whenever events or circumstances
indicate that the carrying amount may not be fully recoverable. Recoverability of assets is
measured by comparison of the carrying amount of the asset to the net undiscounted future cash
flows expected to be generated from the use or disposition of the asset. If the future undiscounted
cash flows are not sufficient to recover the carrying value of the assets, the assets carrying
value is adjusted to fair value. As of June 30, 2008, no impairment had been indicated.
Share-Based Compensation Expense
Effective January 1, 2006, we adopted the fair value recognition provisions of SFAS No.
123(R), using the modified-prospective transition method. Under the fair value recognition
provisions of SFAS No. 123(R), share-based compensation cost is estimated at the grant date based
on the fair value of the award and is recognized as expense, net of estimated pre-vesting
forfeitures, ratably over the vesting period of the award. We selected the Black-Scholes option
pricing model as the most appropriate fair value method for our awards. Calculating share-based
compensation expense requires the input of highly subjective assumptions, including the expected
term of the share-based awards, stock price volatility, and pre-vesting forfeitures. We estimated
the expected term of stock options granted for the three and six month periods ended June 30, 2008
based on the historical term of our stock option awards. We estimated the expected term of stock
options granted for the three and six month periods ended June 30, 2007 based on the simplified
method provided in Staff Accounting Bulletin No. 107. We estimated the volatility of our common
stock at the date of grant based on the historical volatility of our common stock. The assumptions
used in calculating the fair value of share-based awards represent our best estimates, but these
estimates involve inherent uncertainties and the application of management judgment. As a result,
if factors change and we use different assumptions, our share-based compensation expense could be
materially different in the future. In addition, we are required to estimate the expected
pre-vesting forfeiture rate and only recognize expense for those shares expected to vest. We
estimate the pre-vesting forfeiture rate based on historical experience. If our actual forfeiture
rate is materially different from our estimate, our share-based compensation expense could be
significantly different from what we have recorded in the current period.
17
Our net income for the three and six month periods ended June 30, 2008 includes $1.1 million
and $3.0 million, respectively, of share-based compensation expense related to employees and
non-employee members of our board of directors. Our net loss for the three and six month periods
ended June 30, 2007 includes $355,000 and $828,000, respectively, of share-based compensation
expense related to employees and non-employee members of our board of directors.
On February 29, 2008, our board of directors approved a reduction in the offering period of
the Employee Stock Purchase Plan (ESPP) from 12 months to 3 months effective with the next
offering period that begins on September 1, 2008, eliminated the ability of plan participants to
increase their contribution levels during an offering period and authorized the addition of 500,000
shares to the ESPP. In addition, our board of directors approved an amendment on April 16, 2008, to
permanently reduce the maximum offering period available from 27 months to 6 months and to
permanently remove the ability of ESPP participants to increase their contributions during an
offering period. These amendments to the ESPP were approved by our board of directors on February
29, 2008, and April 16, 2008 and by our shareholders at our annual shareholders meeting on May 29,
2008. These plan changes to the ESPP will be effective with the beginning of the next offering
period that begins on September 1, 2008 and could lead to lower expenses for the ESPP in future
periods.
18
Lease Termination Liability
We entered into an agreement to sublease laboratory and office space, including laboratory
equipment, at our Hayward, California facility in July 2000, due to the termination of our then
existing drug discovery programs. The sublease on our Hayward facility expired in July 2006. Our
obligations under the Hayward master lease extend through November 2012. During the fourth quarter
of 2005, the sublessee notified us that they did not intend to extend the sublease beyond the end
of July 2006.
We determined that there was no loss associated with the Hayward facility when we initially
subleased the space as we expected cash inflows from the sublease to exceed our rent cost over the
term of the master lease. However, we reevaluated this in 2005 when the sublessee notified us that
it would not be renewing the sublease beyond July 2006. As a result, we computed a loss and
liability on the sublease in the fourth quarter of 2005 in accordance with FIN 27: Accounting for a
Loss on a Sublease, an interpretation of FASB 13 and APB Opinion No. 30 and FTB 79-15, Accounting
for the Loss on a Sublease Not Involving the Disposal of a Segment. As of June 30, 2008 and
December 31, 2007, the estimated liability related to the Hayward facility totaled $1.4 million and
$1.6 million, respectively, and is included in Lease Termination and Deferred Rent Liabilities in
the accompanying Consolidated Balance Sheets. The fair value of the liability was determined using
a credit-adjusted risk-free rate to discount the estimated future net cash flows, consisting of the
minimum lease payments under the master lease, net of estimated sublease rental income that could
reasonably be obtained from the property. The most significant assumption in estimating the lease
termination liability relates to our estimate of future sublease income. We base our estimate of
sublease income, in part, on the opinion of independent real estate experts, current market
conditions, and rental rates, among other factors. Adjustments to the lease termination liability
will be required if actual sublease income differs from amounts currently expected. We review all
assumptions used in determining the estimated liability quarterly and revise our estimate of the
liability to reflect changes in circumstances. Effective November 1, 2007, we subleased 5,000
square feet of the facility through April 2009 and effective February 1, 2008 we subleased the
remaining 25,000 square feet through the remainder of the term of the master lease. These subleases
cover a portion of our lease commitment, and all of our insurance, taxes and common area
maintenance. As of June 30, 2008, we are obligated to pay rent on the Hayward facility of $3.8
million. Over the remaining term of the master lease, we anticipate that we will receive
approximately $1.7 million in sublease income to be used to pay a portion of our Hayward facility
obligation.
We are also required to recognize an on-going accretion expense representing the difference
between the undiscounted net cash flows and the discounted net cash flows over the remaining term
of the Hayward master lease using the interest method. The accretion amount represents an on-going
adjustment to the estimated liability. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the accompanying
Consolidated Statements of Operations.
Income Taxes
We make certain estimates and judgments in determining income tax expense for financial
statement purposes. These estimates and judgments occur in the calculation of certain tax assets
and liabilities, which arise from differences in the timing of recognition of revenue and expense
for tax and financial statement purposes.
As part of the process of preparing our consolidated financial statements, we are required to
estimate our income taxes in each of the jurisdictions in which we operate. This process involves
us estimating our current tax exposure under the most recent tax laws and assessing temporary
differences resulting from differing treatment of items for tax and accounting purposes. These
differences result in deferred tax assets and liabilities, which are included in our consolidated
balance sheets.
We regularly assess the likelihood that we will be able to recover our deferred tax assets. We
consider all available evidence, both positive and negative, including historical levels of income,
expectations and risks associated with estimates of future taxable income and ongoing prudent and
feasible tax planning strategies in assessing the need for a valuation allowance. If it is not more
likely than not that we will recover our deferred tax assets, we will increase our provision for
taxes by recording a valuation allowance against the deferred tax assets that we estimate will not
ultimately be recoverable. As a result of our analysis of all available evidence, both positive and
negative, as of December 31, 2006, it was not considered more likely than not that our deferred
tax assets would be realized and, accordingly, we recorded a full valuation allowance against the
deferred tax assets. Based on taxable income in the third and fourth quarter of 2007, cumulative
taxable income for the most recent three years and anticipated taxable income for 2008, we
determined, in the fourth quarter of 2007, that it was more likely than not that some of the
deferred tax assets would be recovered. Accordingly, we reversed the valuation allowance for such
deferred tax assets at December 31, 2007 and recorded an income tax benefit of $15.9 million for
the year ended December 31, 2007. The remaining valuation allowance at December 31, 2007 related to
deferred tax assets for federal net operating loss and tax credit carryforwards and certain state
temporary differences that may not be recovered until 2009 or subsequent years. During the second
quarter of 2008 we determined that it was more likely than not that the portion of the reserved
deferred tax asset associated with a federal net operating loss carry forward available to us in
2009 would be
19
recovered and recorded an income tax benefit of approximately $750,000. Any changes in the
valuation allowance based upon our future assessment will result in an income tax benefit if the
valuation allowance is decreased, and an income tax expense if the valuation allowance is
increased.
During the three and six month periods ended June 30, 2008, our effective tax rate for
financial reporting purposes was approximately 39 percent and 40 percent, respectively. Our second
quarter and year to date tax expense for financial reporting purposes includes the benefit of the
reversal of the valuation allowance discussed above. This tax benefit was partially offset by the
impact of the difference for financial reporting and tax purposes of deductions associated with
stock-based compensation. Excluding the impact of the second quarter reversal of the valuation
allowance, we estimate that our 2008 effective tax rate for financial reporting purposes will be
approximately 42 percent. However, we continue to estimate that our actual tax payments related to 2008
are expected to be paid at a rate of approximately 18 percent, as we have access to $29.4 million
and $17.4 million of federal and state operating loss carryforwards, respectively, and $157,000 and
$180,000 of the federal and California research and development credits, respectively, to reduce
our 2008 taxable income. We have made estimated tax payments of $3.8 million for the six months
ended June 30, 2008 associated with our estimated 2008 tax obligations.
Results of Operations
Three months ended June 30, 2008 compared to the three months ended June 30, 2007:
Total Net Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net sales |
|
$ |
24,898 |
|
|
$ |
4,144 |
|
|
$ |
20,754 |
|
|
|
501 |
% |
Net sales for the three month periods ended June 30, 2008 and 2007 were comprised of net sales
of our neurology products Acthar and Doral. Net sales of Acthar for the three month period ended
June 30, 2008 totaled $24.7 million as compared to $3.9 million during the same period in 2007. The
increase in net sales resulted from the new Acthar pricing level implemented in August 2007. In
August 2007 we announced a new strategy and business model for Acthar, and initiated a new pricing
level for Acthar that was effective August 27, 2007. Under the new Acthar strategy, our sales price
to CuraScript, our specialty distributor of Acthar, increased to $22,222 per vial based on a list
price of $23,269 per vial. Effective June 1, 2008, the discounted sales price to CuraScript
increased to $23,039 per vial based on a list price of $23,269 per vial. The list price prior to
the new Acthar pricing level was $1,650 per vial. While total Acthar units shipped have decreased
since the implementation of the new Acthar strategy, we shipped 1,560 Acthar units to our specialty
distributor during the second quarter of 2008. This continued ordering coupled with a positive
pattern of insurance reimbursement and rapid patient access to Acthar has resulted in a significant
increase in our net sales. However, future Acthar orders may be impacted by several factors,
including inventory practices at specialty and hospital pharmacies, greater use of patient
assistance programs, the overall pattern of usage by the healthcare community, including Medicaid
and government entities, the FDA approval of a competitive product, and the reimbursement policies
of insurance companies.
We estimate that seasonally-adjusted end user demand for Acthar since the implementation of
the new Acthar strategy has been at or slightly above the high end of our estimated range of 1,275
to 1,425 vials per quarter. However, Acthar end user demand follows a distinct historical pattern
of significant quarter-to-quarter variability. This quarter-to-quarter variability is the result of
two separate factors seasonality and normal variation in Acthar end user demand in the treatment
of IS. To measure these two factors we evaluated the historical patterns of quarterly Acthar usage
within child neurology, as measured by Wolters-Kluwer, a leading provider of prescription data for
the pharmaceutical industry. We tabulated the average retail demand for each quarter, from July
2002 to June 2007, as a percentage of the overall average quarterly retail demand. According to
these data, while retail demand in child neurology, where Acthar is now primarily used, stayed
constant during the five-year period July 2002 to June 2007, variation from the mean was frequently
observed for individual quarters. The results of the analysis indicate that due to seasonal
factors, end user demand in the first calendar quarter has historically averaged about 15% below
the annual average, the third calendar quarter has historically averaged about 12% above the annual
average, and the second and fourth calendar quarters are slightly above the annual average. The
results of the analysis further indicate that the second factor, normal variation in end user
demand, also deviates quarter-to-quarter at a similar level as the seasonal variations.
As required by federal regulations, we provide a rebate related to product dispensed to
Medicaid eligible patients and government entities are permitted to purchase our products for a
nominal amount from our customers who charge back the significant discount to us. These Medicaid
rebates and government chargebacks are estimated by us each quarter and reduce our gross sales in
the determination of our net sales. Effective January 1, 2008, the
amount we rebate for each Acthar vial dispensed to a Medicaid
eligible patient is approximately $2,500 higher than our price to our
specialty distributor. For the three months ended June 30, 2008, Acthar gross sales
were reduced by approximately 29% to
20
account for the estimated amount of Medicaid rebates and government chargebacks.
We estimate that Acthar gross sales resulting from our reported shipments will be
reduced by approximately 30% related to Medicaid rebates and government chargebacks for 2008.
In addition, for the three months ended June 30, 2008, Acthar gross sales were reduced by approximately 1% to
account for changes in our estimate of return obligations associated with Acthar product lots that
expired in 2007.
If annual Acthar demand remains in the annualized range of 5,100 to 5,700 vials experienced
since the implementation of the new Acthar strategy, this would result in net sales of
approximately $82 million to $91 million.
We review the amount of inventory of Doral at wholesalers and Acthar at CuraScript in order to
help assess the demand for our products. We may choose to defer sales in situations where we
believe inventory levels are already adequate. We expect quarterly fluctuations in net sales due to
changes in demand for our products, the timing of shipments, changes in inventory levels,
expiration dates of product sold, and the impact of our sales-related reserves.
Cost of Sales and Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Cost of sales |
|
$ |
2,190 |
|
|
$ |
914 |
|
|
$ |
1,276 |
|
|
|
140 |
% |
Gross profit |
|
|
22,708 |
|
|
|
3,230 |
|
|
|
19,478 |
|
|
|
603 |
% |
Gross margin |
|
|
91 |
% |
|
|
78 |
% |
|
|
|
|
|
|
|
|
Cost of sales includes material cost, packaging, warehousing and distribution, product
liability insurance, royalties, quality control (which primarily includes product stability
testing), quality assurance and reserves for excess or obsolete inventory. The increase in cost of
sales was due primarily to an increase of $871,000 in royalties on Acthar due to the increase in
net sales during the three month period ended June 30, 2008 as compared to the same period in 2007.
In addition, distribution costs increased by $216,000 and product stability testing expenses
increased by $105,000 in the three month period ended June 30, 2008 as compared to the same period
in 2007. The gross margin was 91% for the three month period ended June 30, 2008, as compared to
78% for the three month period ended June 30, 2007. The increase in the gross margin in the three
month period ended June 30, 2008 as compared to the same period in 2007 was due primarily to the
increase in net sales resulting from the new Acthar pricing level implemented in August 2007. We
estimate that the gross margin for 2008 will be approximately 91%.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
4,855 |
|
|
$ |
4,747 |
|
|
$ |
108 |
|
|
|
2 |
% |
Selling, general and administrative expense for the three months ended June 30, 2008 was
consistent with selling, general and administrative expense in the same period in 2007. Increases
in share-based compensation expense and general costs associated with the support of our new Acthar
strategy were offset by decreases due to lower headcount related costs and lower expenses
associated with our Hayward facility.
We incurred a total non-cash charge of $1.1 million for SFAS No. 123(R) share-based
compensation related to employees and non-employee members of our board of directors for the
quarter ended June 30, 2008. Of this amount, $859,000 was included in selling, general and
administrative expenses, an increase of $567,000 as compared to the same period in 2007. The
increase in share-based compensation expense in the second quarter of 2008 was primarily associated
with our employee stock purchase plan. Of the total non-cash charge of $1.1 million in the second
quarter of 2008 for share-based compensation expense, $584,000 was related to our employee stock
purchase plan. As a result of the significant increase in our stock price during the fourth quarter
of 2007, many plan participants increased their contributions to maximum levels for the current
offering period. This resulted in a significant increase in the non-cash SFAS No. 123(R) expense
for the current 12-month offering period. In February 2008, our board of directors approved a
reduction in the offering period from 12 months to 3 months effective with the next offering period
that begins on September 1, 2008, eliminated the ability of plan participants to increase their
contribution levels during an offering period and approved an
amendment authorizing the addition of 500,000 shares to the
plan. In addition, our board of directors approved an amendment on
April 16, 2008, to permanently reduce the maximum offering period
available from 27 months to 6 months and to permanently remove the
ability of ESPP participants to increase their contributions during
an offering period. These amendments to the plan were approved by shareholders at our annual shareholders meeting
on May 29, 2008. We estimate that these changes could reduce the non-cash SFAS No. 123(R) expense
associated with our employee stock purchase plan subsequent to the end of the current offering
period.
21
General costs associated with the support of our new Acthar strategy increased by
approximately $720,000 in the three month period ended June 30, 2008 as compared to general costs
associated with our prior strategy incurred during the same period in 2007. General costs
associated with our new Acthar strategy during the second quarter of 2008 relate primarily to our
patient assistance programs.
Headcount related costs included in selling, general and administrative expense, excluding
share-based compensation, decreased by approximately $540,000 as compared to the same period in
2007. In May 2007, we reduced our field organization from 45 sales representatives to 10 product
service consultants and 4 medical science liaisons. The expenses associated with our medical
science liaisons are included in Research and Development expense in the accompanying Consolidated
Statements of Operations. Selling, general and administrative expense for the three month period
ended June 30, 2007 includes severance benefits and other associated costs related to the reduction
of our field organization and the departure of our former Chief Executive Officer in the second
quarter of 2007.
Expenses associated with our Hayward facility decreased by approximately $500,000 in the three
month period ended June 30, 2008 as compared to the same period in 2007. The decrease is due
primarily to the inclusion in the second quarter of 2007 of a $401,000 loss resulting from a
revision of our estimate of our Hayward lease liability.
We estimate that our selling, general and administrative expense (excluding non-cash SFAS No.
123(R) share-based compensation expense) for 2008 will be in the range of approximately $15.0
million to $17.0 million. During the second quarter of 2008 we increased our field organization to
a total of 15 product service consultants. We estimate that our total non-cash SFAS No. 123(R)
share-based compensation expense for 2008 will be approximately $4.5 million of which we estimate
approximately $3.5 million will be incurred in selling, general and administrative expense.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
3,555 |
|
|
$ |
951 |
|
|
$ |
2,604 |
|
|
|
274 |
% |
Costs included in research and development relate primarily to our product development
efforts, costs related to the resubmission of our Acthar sNDA for IS to the FDA, outside services
related to medical and regulatory affairs, compliance activities, and costs associated with our
medical science liaisons. The increase in research and development expenses was due primarily to an
increase in costs related to our continued efforts to complete the resubmission of our sNDA for IS
and an increase in expenses associated with our product development efforts. Expenses related to
the resubmission of our sNDA and product development increased approximately $1.4 million in the
three month period ended June 30, 2008 as compared to the same period in 2007. In addition,
activities associated with our medical science liaisons contributed approximately $325,000 to the
increase in research and development expenses in the three month period ended June 30, 2008. These
activities include the initiation of basic research funding for infantile spasms.
Headcount-related costs, excluding share-based compensation, increased by approximately $257,000 in
the three month period ended June 30, 2008 as compared to the same period in 2007, due primarily to
the addition of our medical science liaisons during the second quarter of 2007. A non-cash charge
of $286,000 for SFAS No. 123(R) share-based compensation was included in research and development
expenses in the three month period ended June 30, 2008, an increase of $224,000 as compared to the
same period in 2007.
We estimate that our research and development expenses (excluding non-cash SFAS No. 123(R)
share-based compensation expense) will be approximately $10.0 million to $14.0 million during 2008
resulting from our efforts related to the Acthar submission to the FDA for the treatment of IS, our
support of external research and the continued efforts related to the development of QSC-001. We
estimate that total non-cash SFAS No. 123(R) share-based compensation expense for 2008 will be
approximately $4.5 million of which we estimate approximately $1.0 million will be incurred in
research and development expense.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
123 |
|
|
$ |
125 |
|
|
$ |
(2 |
) |
|
|
(2 |
)% |
22
Depreciation and amortization expense for the three months ended June 30, 2008 was consistent
with depreciation and amortization expense for the same period in 2007.
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
244 |
|
|
$ |
876 |
|
|
$ |
(632 |
) |
|
|
(72 |
)% |
Other income, net for the three month period ended June 30, 2008 decreased $632,000 as
compared to other income, net for the same period in 2007. The decrease was due primarily to the
inclusion in the three month period ended June 30, 2007 of the gain on sale of product rights
related to Emitasol. In June 2007, we divested our non-core development stage product Emitasol
(nasal metoclopramide) which resulted in a gain of $448,000. In addition, in June 2007 we reversed
an accrual of $248,000 related to an agreement with Roberts Pharmaceutical Corporation, a
subsidiary of Shire Pharmaceuticals Ltd. (Shire), as we determined that the amount would not be
due to Shire under the agreement.
Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Income tax expense |
|
$ |
5,625 |
|
|
$ |
|
|
|
$ |
5,625 |
|
|
|
|
|
Income tax expense for the three month period ended June 30, 2008 was $5.6 million. There was
no income tax expense for the three month period ended June 30, 2007 as we incurred a net loss of
$1.7 million. During the quarter ended June 30, 2008, our effective tax rate for financial
reporting purposes was approximately 39 percent. Income tax expense for financial reporting
purposes for the three month period ended June 30, 2008 includes the benefit of the reversal of a
valuation allowance associated with a federal net operating loss carry forward available to us in
2009 of approximately $750,000. During the second quarter of 2008, we determined, based on taxable
income for the six month period ended June 30, 2008 and anticipated income for 2008 and 2009, that
it is more likely than not that these deferred tax assets would be realized. The tax benefit
resulting from the reversal of the valuation reserve was partially offset by the impact of the
difference for financial reporting and tax purposes of deductions associated with stock-based
compensation. Excluding the impact of the second quarter reversal of the valuation allowance, we
estimate that our 2008 effective tax rate for financial reporting purposes will be approximately
42 percent. However, we continue to estimate that our actual tax payments related to 2008 are expected to
be paid at a rate of approximately 18 percent, as we have access to $29.4 million and $17.4 million
of federal and state operating loss carryforwards, respectively, and $157,000 and $180,000 of the
federal and California research and development credits, respectively, to reduce our 2008 taxable
income. We made estimated tax payments of $3.4 million during the three months ended June 30, 2008
associated with our estimated 2008 tax obligations.
Net Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income (loss) |
|
$ |
8,794 |
|
|
$ |
(1,717 |
) |
|
$ |
10,511 |
|
|
|
612 |
% |
For the three months ended June 30, 2008, we had net income of $8.8 million as compared to a
net loss of $1.7 million for the three months ended June 30, 2007, an increase of $10.5 million.
The increase resulted primarily from the implementation of our new strategy and business model for
Acthar.
Net Income (Loss) Applicable to Common Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income (loss) applicable to common shareholders |
|
$ |
8,794 |
|
|
$ |
(1,717 |
) |
|
$ |
10,511 |
|
|
|
612 |
% |
23
For the three months ended June 30, 2008, we had net income applicable to common shareholders
of $8.8 million, or $0.12 per fully diluted share, as compared to a net loss applicable to common
shareholders of $1.7 million, or $0.02 loss per share, for the three months ended June 30, 2007, an
increase of $10.5 million. The increase resulted primarily from the implementation of our new
strategy and business model for Acthar.
Six months ended June 30, 2008 compared to the six months ended June 30, 2007:
Total Net Sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net sales |
|
$ |
44,030 |
|
|
$ |
7,845 |
|
|
$ |
36,185 |
|
|
|
461 |
% |
Net sales for the six month periods ended June 30, 2008 and 2007 were comprised of net sales
of our neurology products Acthar and Doral. Net sales of Acthar for the six month period ended June
30, 2008 totaled $43.6 million as compared to $7.2 million during the same period in 2007. The
increase in net sales resulted from the new Acthar pricing level implemented in August 2007. In
August 2007 we announced a new strategy and business model for Acthar, and initiated a new pricing
level for Acthar that was effective August 27, 2007. Under the new Acthar strategy, our sales price
to CuraScript, our specialty distributor of Acthar, increased to $22,222 per vial based on a list
price of $23,269 per vial effective August 27, 2007. Effective June 1, 2008, the discounted sales
price to CuraScript increased to $23,039 per vial based on a list price of $23,269 per vial. The
list price prior to the new Acthar pricing level was $1,650 per vial. While total Acthar units
shipped have decreased since the implementation of the new Acthar strategy, we shipped 2,820 Acthar
units to our specialty distributor during the first six months of 2008. This continued ordering
coupled with a positive pattern of insurance reimbursement and rapid patient access to Acthar has
resulted in a significant increase in our net sales. However, future Acthar orders may be impacted
by several factors, including inventory practices at specialty and hospital pharmacies, greater use
of patient assistance programs, the overall pattern of usage by the healthcare community, including
Medicaid and government entities, the FDA approval of a competitive product, and the reimbursement
policies of insurance companies.
We estimate that seasonally-adjusted end user demand for Acthar since the implementation of
the new Acthar strategy has been at or slightly above the high end of our estimated range of
between 1,275 to 1,425 vials per quarter. However, Acthar end user demand follows a distinct
historical pattern of significant quarter-to-quarter variability. This quarter-to-quarter
variability is the result of two separate factors seasonality and normal variation in Acthar end
user demand in the treatment of IS. To measure these two factors we evaluated the historical
patterns of quarterly Acthar usage within child neurology, as measured by Wolters-Kluwer, a leading
provider of prescription data for the pharmaceutical industry. We tabulated the average retail
demand for each quarter, from July 2002 to June 2007, as a percentage of the overall average
quarterly retail demand. According to these data, while retail demand in child neurology, where
Acthar is now primarily used, stayed constant during the five-year period July 2002 to June 2007,
variation from the mean was frequently observed for individual quarters. The results of the
analysis indicate that due to seasonal factors, end user demand in the first calendar quarter has
historically averaged about 15% below the annual average, the third calendar quarter has
historically averaged about 12% above the annual average, and the second and fourth calendar
quarters are slightly above the annual average. The results of the analysis further indicate that
the second factor, normal variation in end user demand, also deviates quarter-to-quarter at a
similar level as the seasonal variations.
As required by federal regulations, we provide a rebate related to product dispensed to
Medicaid eligible patients and government entities are permitted to purchase our products for a
nominal amount from our customers who charge back the significant discount to us. These Medicaid
rebates and government chargebacks are estimated by us each quarter and reduce our gross sales in
the determination of our net sales. Effective January 1, 2008, the
amount we rebate for each Acthar vial dispensed to a Medicaid
eligible patient is approximately $2,500 higher than our price to our
specialty distributor. For the six months ended June 30, 2008, Acthar gross sales were
reduced by approximately 30% to account for the estimated amount of Medicaid rebates and government
chargebacks. We estimate that Acthar gross sales resulting from our
reported shipments will be reduced by approximately 30% related to Medicaid rebates and government
chargebacks for 2008. In addition, for the six months ended June 30, 2008, Acthar gross sales were reduced
by approximately 1% to account for changes in our estimate of return obligations associated with
Acthar product lots that expired in 2007.
If annual Acthar demand remains in the annualized range of 5,100 to 5,700 vials experienced
since the implementation of the new Acthar strategy, this would result in net sales of
approximately $82 million to $91 million.
24
Cost of Sales and Gross Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Cost of sales |
|
$ |
3,509 |
|
|
$ |
1,764 |
|
|
$ |
1,745 |
|
|
|
99 |
% |
Gross profit |
|
|
40,521 |
|
|
|
6,081 |
|
|
|
34,440 |
|
|
|
566 |
% |
Gross margin |
|
|
92 |
% |
|
|
78 |
% |
|
|
|
|
|
|
|
|
The increase in cost of sales was due primarily to an increase of $1.4 million in royalties on
Acthar due to the increase in net sales during the six month period ended June 30, 2008 as compared
to the same period in 2007, and an increase of $591,000 in distribution costs in the six month
period ended June 30, 2008 as compared to the same period in 2007. The increase in distribution
costs is due in part to the inclusion in the six month period ended June 30, 2007 of credits from
wholesalers related to price increases. These increases were partially offset by a decrease in
product stability testing expenses and inventory obsolescence totaling approximately $409,000
during the six month period ended June 30, 2008 as compared to the same period in 2007. The gross
margin was 92% for the six month period ended June 30, 2008, as compared to 78% for the six month
period ended June 30, 2007. The increase in the gross margin in the six month period ended June 30,
2008 as compared to the same period in 2007 was due primarily to the increase in net sales
resulting from the new Acthar pricing level implemented in August 2007. We estimate that the gross
margin for 2008 will be approximately 91%.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Selling, general and administrative expense |
|
$ |
9,921 |
|
|
$ |
10,297 |
|
|
$ |
(376 |
) |
|
|
(4 |
)% |
The decrease in selling, general and administrative expense was due primarily to lower
headcount related costs resulting from the reduction of our field organization in the second
quarter of 2007 and lower expenses associated with our Hayward facility, offset in part by an
increase in share-based compensation expense and general costs associated with the support of our
new Acthar strategy.
Headcount related costs included in selling, general and administrative expense, excluding
share-based compensation, decreased by approximately $1.4 million as compared to the same period in
2007. Selling, general and administrative expense for the six month period ended June 30, 2007
includes severance benefits and other associated costs related to the reduction of our field
organization and the departure of our former Chief Executive Officer in the second quarter of 2007.
Expenses associated with our Hayward facility decreased by approximately $590,000 in the six
month period ended June 30, 2008 as compared to the same period in 2007. The decrease is due
primarily to the inclusion of a $401,000 loss in the six month period ended June 30, 2007 resulting
from a revision of our estimate of our Hayward lease liability.
We incurred a total non-cash charge of $3.0 million for SFAS No. 123(R) share-based
compensation related to employees and non-employee members of our board of directors for the six
months ended June 30, 2008. Of this amount, $2.5 million was included in selling, general and
administrative expenses, an increase of $1.8 million as compared to the same period in 2007. The
increase in share-based compensation expense in the six months ended June 30, 2008 was primarily
associated with our employee stock purchase plan. Of the total non-cash charge of $3.0 million in
the first six months of 2008 for share-based compensation expense, $1.8 million was related to our
employee stock purchase plan. As a result of the significant increase in our stock price during the
fourth quarter of 2007, many plan participants increased their contributions to maximum levels for
the current offering period. This resulted in a significant increase in the non-cash SFAS No.
123(R) expense for the current 12-month offering period. In February 2008, our board of directors
approved a reduction in the offering period from 12 months to 3 months effective with the next
offering period that begins on September 1, 2008, eliminated the ability of plan participants to
increase their contribution levels during an offering period and approved an amendment authorizing the addition of 500,000
shares to the plan. In addition, our board of directors approved an amendment on
April 16, 2008, to permanently reduce the maximum offering period
available from 27 months to 6 months and to permanently remove the
ability of ESPP participants to increase their contributions during
an offering period. These amendments to the plan were approved by shareholders at our annual
shareholders meeting on May 29, 2008. We estimate that these changes could reduce the non-cash
SFAS No. 123(R) expense associated with our employee stock purchase plan subsequent to the end of
the current offering period.
General costs associated with the support of our new Acthar strategy increased by
approximately $200,000 in the six month period ended June 30, 2008 as compared to general costs
associated with our prior strategy incurred during the same period in 2007. General costs
associated with our new Acthar strategy during 2008 relate primarily to our patient assistance
programs.
25
We estimate that our selling, general and administrative expense (excluding non-cash SFAS No.
123(R) share-based compensation expense) for 2008 will be in the range of approximately $15.0
million to $17.0 million. During the second quarter of 2008 we increased our field organization to
a total of 15 product service consultants. We estimate that our total non-cash SFAS No. 123(R)
share-based compensation expense for 2008 will be approximately $4.5 million of which we estimate
approximately $3.5 million will be incurred in selling, general and administrative expense.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Research and development |
|
$ |
5,526 |
|
|
$ |
2,091 |
|
|
$ |
3,435 |
|
|
|
164 |
% |
The increase in research and development expenses was due primarily to an increase in costs
related to our continued efforts to complete the resubmission of our sNDA for IS and the addition
of our medical science liaisons during the second quarter of 2007. Expenses related to the
resubmission of our sNDA increased approximately $1.5 million in the six month period ended June
30, 2008 as compared to the same period in 2007. Headcount-related costs, excluding share-based
compensation, increased by approximately $513,000 in the six month period ended June 30, 2008 as
compared to the same period in 2007, due primarily to the addition of our medical science liaisons
during the second quarter of 2007. In addition, activities associated with our medical science
liaisons contributed approximately $385,000 to the increase in research and development expenses in
the six month period ended June 30, 2008. These activities include the initiation of basic
research funding for infantile spasms. A non-cash charge of $520,000 for SFAS No. 123(R)
share-based compensation was included in research and development expenses in the six month period
ended June 30, 2008, an increase of $391,000 as compared to the same period in 2007.
We estimate that our research and development expenses (excluding non-cash SFAS No. 123(R)
share-based compensation expense) will be approximately $10.0 million to $14.0 million during 2008
resulting from our efforts related to the Acthar submission to the FDA for the treatment of IS, our
support of external research and the continued efforts related to the development of QSC-001. We
estimate that total non-cash SFAS No. 123(R) share-based compensation expense for 2008 will be
approximately $4.5 million of which we estimate approximately $1.0 million will be incurred in
research and development expense.
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Depreciation and amortization |
|
$ |
245 |
|
|
$ |
248 |
|
|
$ |
(3 |
) |
|
|
(1 |
)% |
Depreciation and amortization expense for the six months ended June 30, 2008 was consistent
with depreciation and amortization expense for the same period in 2007.
Other Income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Decrease |
|
Change |
|
|
(in $000s) |
Other income, net |
|
$ |
619 |
|
|
$ |
1,079 |
|
|
$ |
(460 |
) |
|
|
(43 |
)% |
Other income, net for the six month period ended June 30, 2008 decreased $460,000 as compared
to other income, net for the same period in 2007. The decrease was due primarily to the inclusion
in the six month period ended June 30, 2007 of the gain on sale of product rights related to
Emitasol, and the reversal of an accrual of $248,000 related to an agreement with Roberts
Pharmaceutical Corporation, a subsidiary of Shire, as we determined that the amount would not be
due to Shire under the agreement. In June 2007, we divested our non-core development stage product
Emitasol (nasal metoclopramide) which resulted in a gain of $448,000.
26
Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Income tax expense |
|
$ |
10,113 |
|
|
$ |
|
|
|
$ |
10,113 |
|
|
|
|
|
Income tax expense for the six month period ended June 30, 2008 was $10.1 million. There was
no income tax expense for the six month period ended June 30, 2007 as we incurred a net loss of
$5.5 million. During the six month period ended June 30, 2008, our effective tax rate for financial
reporting purposes was approximately 40 percent. Income tax expense for financial reporting
purposes for the six month period ended June 30, 2008 includes the benefit of the reversal of a
valuation allowance associated with a federal net operating loss carry forward available to us in
2009 of approximately $750,000. During the second quarter of 2008, we determined, based on taxable
income for the six month period ended June 30, 2008 and anticipated income for 2008 and 2009, that
it is more likely than not that these deferred tax assets would be realized. The tax benefit
resulting from the reversal of the valuation reserve was partially offset by the impact of the
difference for financial reporting and tax purposes of deductions associated with stock-based
compensation. Excluding the impact of the second quarter reversal of the valuation allowance, we
estimate that our 2008 effective tax rate for financial reporting purposes will be approximately
42 percent. However, we continue to estimate that our actual tax payments related to 2008 are expected to
be paid at a rate of approximately 18 percent, as we have access to $29.4 million and $17.4 million
of federal and state operating loss carryforwards, respectively, and $157,000 and $180,000 of the
federal and California research and development credits, respectively, to reduce our 2008 taxable
income. We made estimated tax payments of $3.8 million for the six months ended June 30, 2008
associated with our estimated 2008 tax obligations.
Net Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Net income (loss) |
|
$ |
15,335 |
|
|
$ |
(5,476 |
) |
|
$ |
20,811 |
|
|
|
380 |
% |
For the six months ended June 30, 2008, we had net income of $15.3 million as compared to a
net loss of $5.5 million for the six months ended June 30, 2007, an increase of $20.8 million. The
increase resulted primarily from the implementation of our new strategy and business model for
Acthar.
Deemed Dividend on Series A Preferred Stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
(in $000s) |
Deemed dividend on Series A Preferred Stock |
|
$ |
5,267 |
|
|
$ |
|
|
|
$ |
5,267 |
|
|
|
|
|
The deemed dividend resulted from the repurchase of our Series A Preferred Stock in February
2008. On February 19, 2008, we completed the repurchase of the outstanding 2,155,715 shares of
Series A Preferred Stock from Shire Pharmaceuticals, Inc. for cash consideration of $10.3 million
or $4.80 per share (the same price per preferred share as the closing price per share of our common
stock on February 19, 2008). As of December 31, 2007, the Series A Preferred Stock had a carrying
amount of $5.1 million as reflected on the accompanying Consolidated Balance Sheet. The deemed
dividend represents the difference between the $10.3 million repurchase payment and the $5.1
million balance sheet carrying value of the Series A Preferred Stock. The repurchase transaction
had no income tax impact.
Net Income (Loss) Applicable to Common Shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
% |
|
|
2008 |
|
2007 |
|
Increase |
|
Change |
|
|
|
|
|
|
(in $000s) |
|
|
|
|
Net income (loss) applicable to common shareholders |
|
$ |
10,068 |
|
|
$ |
(5,476 |
) |
|
$ |
15,544 |
|
|
|
284 |
% |
For the six months ended June 30, 2008, we had net income applicable to common shareholders of
$10.1 million, or $0.14 per fully diluted share, as compared to a net loss applicable to common
shareholders of $5.5 million, or $0.08 loss per share, for the six months ended June 30, 2007, an
increase of $15.5 million. The increase resulted primarily from the implementation of our new
27
strategy and business model for Acthar. The $5.3 million reduction to net income related to
the deemed dividend on the repurchased Series A Preferred Stock, reduced fully diluted earnings per
share applicable to common shareholders by $0.07.
Liquidity and Capital Resources
Prior to the implementation of our new strategy and business model for Acthar, we principally
funded our activities through various issuances of equity securities and debt and from the sale of
our non-core commercial product lines in October 2005. During the six month period ended June 30,
2008, we generated $29.9 million in cash from operations resulting from the implementation of our
new Acthar strategy.
At June 30, 2008, we had cash, cash equivalents and short-term investments of $38.9 million
compared to $30.2 million at December 31, 2007. The increase was due primarily to $29.9 million of
cash generated from operations, partially offset by $11.8 million paid to repurchase our common
stock and the $10.3 million payment for the repurchase of our Series A preferred stock. At June 30,
2008, our working capital was $54.1 million compared to $57.2 million at December 31, 2007. The
decrease in our working capital was principally due to a decrease in deferred tax assets of $6.4
million, a decrease in accounts receivable of $2.1 million, and an increase of $4.2 million in
sales-related reserves partially offset by the $8.7 million increase in cash, cash equivalents and
short-term investments as of June 30, 2008.
On February 19, 2008, we completed the repurchase of the outstanding 2,155,715 shares of
Series A Preferred Stock from Shire Pharmaceuticals, Inc. for cash consideration of $10.3 million
or $4.80 per share (the same price per preferred share as the closing price per share of our common
stock on February 19, 2008). The existence of the Series A Preferred Stock created a complex
capital structure that limited our flexibility in developing a long-term strategy and required us
to take into consideration the interest of the preferred stockholder. For example, among other
rights associated with the Series A Preferred Stock, the Series A Preferred Stock was convertible
into 2,155,715 shares of common stock, had a $10 million liquidation preference and required us to
obtain the holders separate approval in the event of a merger transaction.
In March 2008, we announced that our board of directors approved a stock repurchase plan that
provides for our repurchase of up to 7 million of our common shares in either open market or
private transactions, which will occur from time to time and in such amounts as management deems
appropriate. To date, we have repurchased a total of 3,327,900 shares of our common stock for $14.7
million under our stock repurchase plan.
In
addition, on August 13, 2008, we completed a
board-approved repurchase of
2,200,000 shares of our common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal
L.D.A, an entity owned by Paolo Cavazza and members of his family, for $10.9 million or $4.95 per
share. This repurchase was made outside of our
existing share repurchase plan. After distributing this
$10.9 million, our total cash, cash equivalents and short-term
investments were approximately $46 million.
In April 2008, we announced the amendment of our distribution agreement with CuraScript. The
amendment became effective on June 1, 2008. Under the amended agreement, the payment terms have
been reduced from 60 days to 30 days. The reduction in payment terms reduced our accounts
receivable balance and generated a one-time increase in our cash balance during July 2008 of
approximately $10 million.
We lease a 30,000 square foot facility in Hayward, California. Our master lease on the Hayward
facility expires in November 2012. As of June 30, 2008, we were obligated to pay rent on the
Hayward facility of $3.8 million and to pay our share of insurance, taxes and common area
maintenance through the expiration of the master lease. Effective November 1, 2007, we subleased
5,000 square feet of the facility through April 2009 and effective February 1, 2008 we subleased
the remaining 25,000 square feet through the remainder of the term of the master lease. These
subleases cover a portion of our lease commitment, and all of our insurance, taxes and common area
maintenance.
If annual Acthar demand remains in the annualized range of 5,100 to 5,700 vials experienced
since the implementation of the new Acthar strategy and our estimates for expenses are achieved, we
estimate that cash from operations generated during 2008 will be approximately $50 million to $60
million.
Recently Issued Accounting Standards
In April 2008, the FASB issued FSP FAS No. 142-3, Determination of the Useful Life of
Intangible Assets (FSP FAS No. 142-3). In determining the useful life of intangible assets, FSP
FAS No. 142-3 removes the requirement to consider whether an intangible
28
asset can be renewed without substantial cost of material modifications to the existing terms
and conditions and, instead, requires an entity to consider its own historical experience in
renewing similar arrangements. FSP FAS No. 142-3 also requires expanded disclosure related to the
determination of intangible asset useful lives. FSP FAS No. 142-3 is effective for financial
statements issued for fiscal years beginning after December 15, 2008. We do not expect that the
adoption of FSP FAS No. 142-3 will have a material impact on our financial position and results of
operations.
In February 2008, the FASB issued FASB Staff Position No. FAS 157-2, Effective Date of FASB
Statement No. 157 (FSP FAS No. 157-2), which defers the effective date of SFAS No. 157 for all
non-financial assets and non-financial liabilities, except those that are recognized or disclosed
at fair value in the financial statements on a recurring basis (at least annually), for fiscal
years beginning after November 15, 2008 and interim periods within those fiscal years for items
within the scope of FSP FAS No. 157-2. We do not expect that the adoption of FSP FAS No. 157-2 will
have a material impact on our financial position and results of operations.
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations (SFAS No. 141(R)),
which replaces FAS No. 141. SFAS No. 141(R) establishes principles and requirements for how an
acquirer in a business combination recognizes and measures in its financial statements the
identifiable assets acquired, the liabilities assumed, and any controlling interest; recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain purchase; and
determines what information to disclose to enable users of the financial statements to evaluate the
nature and financial effects of the business combination. SFAS No. 141(R) is to be applied
prospectively to business combinations for which the acquisition date is on or after an entitys
fiscal year that begins after December 15, 2008. We will assess the impact of SFAS No. 141(R) if
and when a future acquisition occurs.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of ARB No. 51 (SFAS No. 160). SFAS No. 160 establishes new
accounting and reporting standards for the noncontrolling interest in a subsidiary and for the
deconsolidation of a subsidiary. Specifically, this statement requires the recognition of a
noncontrolling interest (minority interest) as equity in the consolidated financial statements and
separate from the parents equity. The amount of net income attributable to the noncontrolling
interest will be included in consolidated net income on the face of the income statement. SFAS No.
160 clarifies that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains its controlling financial interest.
In addition, this statement requires that a parent recognize a gain or loss in net income when a
subsidiary is deconsolidated. Such gain or loss will be measured using the fair value of the
noncontrolling equity investment on the deconsolidation date. SFAS No. 160 also includes expanded
disclosure requirements regarding the interests of the parent and its noncontrolling interest. SFAS
No. 160 is effective for fiscal years, and interim periods within those fiscal years, beginning on
or after December 15, 2008. Earlier adoption is prohibited. We do not expect that the adoption of
SFAS No. 160 will have a material impact on our financial position and results of operations.
In November 2007, the EITF issued EITF Issue No. 07-1, Accounting for Collaborative
Arrangements Related to the Development and Commercialization of Intellectual Property (EITF
07-1). Companies may enter into arrangements with other companies to jointly develop, manufacture,
distribute, and market a product. Often the activities associated with these arrangements are
conducted by the collaborators without the creation of a separate legal entity (that is, the
arrangement is operated as a virtual joint venture). The arrangements generally provide that the
collaborators will share, based on contractually defined calculations, the profits or losses from
the associated activities. Periodically, the collaborators share financial information related to
product revenues generated (if any) and costs incurred that may trigger a sharing payment for the
combined profits or losses. The consensus requires collaborators in such an arrangement to present
the result of activities for which they act as the principal on a gross basis and report any
payments received from (made to) other collaborators based on other applicable GAAP or, in the
absence of other applicable GAAP, based on analogy to authoritative accounting literature or a
reasonable, rational, and consistently applied accounting policy election. EITF 07-1 is effective
for collaborative arrangements in place at the beginning of the annual period beginning after
December 15, 2008. We do not expect that the adoption of EITF 07-1 will have a material impact on
our financial position and results of operations.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk at June 30, 2008 has not changed materially from December 31,
2007, and reference is made to the more detailed disclosures of market risk included in our Annual
Report on Form 10-K for the year ended December 31, 2007.
ITEM 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our Exchange Act reports is recorded, processed, summarized and
reported within the time periods specified in the Securities and Exchange Commissions rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow for timely decisions
regarding required disclosure.
29
In designing and evaluating the disclosure controls and procedures, management recognizes that
any controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and management is required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our
disclosure controls and procedures were designed to provide reasonable assurance that the controls
and procedures would meet their objectives.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and Chief Financial
Officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the quarter covered by this report. Based on the foregoing, our Chief Executive
Officer and Chief Financial Officer concluded that our disclosure controls and procedures were
effective at the reasonable assurance level.
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Not applicable
ITEM 1A. RISK FACTORS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and
uncertainties. The Companys actual results could differ materially from those discussed herein.
Factors that could cause or contribute to such differences include, but are not limited to:
|
|
|
the Companys ability to continue to successfully implement its strategy and business
model for Acthar, |
|
|
|
|
the failure to maintain an adequate level of reimbursement for Acthar from third
party payors, |
|
|
|
|
that regulatory changes, including possible outcomes relating
to a recent Congressional hearing on orphan drug pricing, could negatively affect the implementation of the Companys
strategy, |
|
|
|
|
the introduction of competitive products, |
|
|
|
|
the Companys ability to accurately forecast the demand for its products, |
|
|
|
|
the gross margin achieved from the sale of the Companys products, |
30
|
|
|
the Companys ability to enforce its product returns policy, |
|
|
|
|
the Companys ability to estimate the quantity of Acthar used by government entities and
Medicaid-eligible patients, |
|
|
|
|
that the actual amount of rebates and discounts related to the use of Acthar by
government entities and Medicaid-eligible patients may differ materially from the Companys
estimates, |
|
|
|
|
the outsourcing of the Companys Acthar distribution functions to CuraScript, |
|
|
|
|
the sell-through by the Companys distributors, |
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|
|
the expenses and other cash needs for upcoming periods, |
|
|
|
|
the inventories carried by the Companys distributors, specialty pharmacies and
hospitals, |
|
|
|
|
volatility in the Companys monthly and quarterly Acthar shipments and end-user demand, |
|
|
|
|
the Companys ability to obtain finished goods from its sole source contract
manufacturers on a timely basis if at all, |
|
|
|
|
the Companys ability to retain key management personnel, |
|
|
|
|
the Companys ability to utilize its net operating loss carry forwards to reduce income
taxes on taxable income, |
|
|
|
|
the Companys ability to maintain an effective system of internal controls, |
|
|
|
|
that product liability lawsuits could be successfully brought against the Company or the
Company becomes subject to other forms of litigation, |
|
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|
|
research and development risks, |
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|
|
uncertainties regarding the Companys intellectual property, |
|
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|
|
the uncertainty of receiving required regulatory approvals in a timely way, or at
all, and |
|
|
|
|
other research, development, and regulatory risks. |
These and other risks are described in Part I, Item 1A of the Companys Annual Report on Form
10-K for the year ended December 31, 2007.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Issuer Purchases of Equity Securities:
|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number |
|
Maximum Number |
|
|
|
|
|
|
Average |
|
Of Shares Purchased |
|
Of Shares That May |
|
|
Total Number |
|
Price |
|
as Part of |
|
Yet be Purchased |
|
|
of Shares |
|
Paid per |
|
Publicly Announced |
|
Under the Plans or |
Period |
|
Purchased |
|
Share |
|
Plans or Programs |
|
Programs |
April 1 April 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,472,300 |
|
May 1 May 31, 2008 |
|
|
286,600 |
|
|
$ |
4.52 |
|
|
|
286,600 |
|
|
|
5,185,700 |
|
June 1 June 30, 2008 |
|
|
926,600 |
|
|
$ |
4.68 |
|
|
|
926,600 |
|
|
|
4,259,100 |
|
|
Total |
|
|
1,213,200 |
|
|
$ |
4.64 |
|
|
|
1,213,200 |
|
|
|
|
|
On February 29, 2008, the Companys board of directors approved a stock repurchase plan that
provides for the Companys repurchase of up to 7 million of its common shares. The stock repurchase
plan was publicly announced on March 3, 2008. Stock repurchases under this program may be made
through open market or privately negotiated transactions in accordance with all applicable laws,
rules and regulations. The transactions may be made from time to time and in such amounts as
management deems appropriate and will be funded from available working capital. The stock
repurchase program does not have an expiration date and may be limited or terminated at any time by
the board of directors without prior notice.
31
From July 1, 2008 through July 25, 2008, the Company repurchased an additional 587,000 shares
of its common stock at an average price of $4.96 per share, for a total purchase price of $2.9
million under its stock repurchase program. To date, the Company has repurchased a total of
3,327,900 shares of its common stock for $14.7 million under its stock repurchase plan.
On
August 13, 2008, the Company completed a board-approved
repurchase of an additional
2,200,000 shares of its common stock from Chaumiere Consultadorio & Servicos SDC Unipessoal
L.D.A, an entity owned by Paolo Cavazza and members of his family, for $10.9 million or $4.95 per
share. This repurchase was made outside of the Companys existing share repurchase plan.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Company held its 2008 Annual Meeting of Shareholders on May 29, 2008. The following
matters received the votes at the 2008 Annual Meeting of Shareholders as set forth below:
|
1. |
|
Election of Directors to hold office until the 2009 Annual Meeting of Shareholders and
until their successors are duly elected and qualified. |
|
|
|
|
|
|
|
|
|
|
|
Votes For |
|
Votes Withheld |
Don M. Bailey |
|
|
50,706,800 |
|
|
|
1,233,360 |
|
Neal C. Bradsher |
|
|
50,710,156 |
|
|
|
1,230,004 |
|
Stephen C. Farrell |
|
|
50,707,204 |
|
|
|
1,232,956 |
|
Virgil D. Thompson |
|
|
50,702,741 |
|
|
|
1,237,419 |
|
David Young |
|
|
50,709,546 |
|
|
|
1,230,614 |
|
|
2. |
|
Approval of the amendment to the Companys 2003 Employee Stock Purchase Plan to add
500,000 additional shares to the Plan, remove the ability of Plan participants to increase
their contributions during an offering period and to permanently reduce the maximum offering
period from 27 months to 6 months. |
|
|
|
|
|
For: |
|
|
30,992,961 |
|
Against: |
|
|
674,215 |
|
Abstain: |
|
|
13,388 |
|
|
3. |
|
Ratification of Odenberg Ullakko Muranishi & Co. LLP as the Companys independent
auditors for the fiscal year ending December 31, 2008. |
|
|
|
|
|
For: |
|
|
51,511,283 |
|
Against: |
|
|
338,634 |
|
Abstain: |
|
|
90,243 |
|
ITEM 5. OTHER INFORMATION
Not applicable
32
ITEM 6. EXHIBITS
|
|
|
Exhibit No |
|
Description |
|
31
|
|
Certifications pursuant to Rule 13a-14 under the Securities
Exchange Act of 1934, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
32*
|
|
Certifications pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
33
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
|
|
|
|
|
QUESTCOR PHARMACEUTICALS, INC.
|
|
Date: August 13, 2008 |
By: |
/s/ Don M. Bailey
|
|
|
|
Don M. Bailey |
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
By: |
/s/ George Stuart
|
|
|
|
George Stuart |
|
|
|
Senior Vice President, Finance and
Chief Financial Officer |
|
34
Exhibit Index
|
|
|
Exhibit No |
|
Description |
|
31
|
|
Certifications pursuant to Rule 13a-14 under the Securities
Exchange Act of 1934, as adopted pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
32*
|
|
Certifications pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
* |
|
These certifications are being furnished solely to accompany this quarterly report pursuant
to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the
Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of
Questcor Pharmaceuticals, Inc., whether made before or after the date hereof, regardless of
any general incorporation language in such filing. |
35
exv31
EXHIBIT 31
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Don M. Bailey, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
|
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) |
|
designed such internal controls over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
|
|
c) |
|
evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
d) |
|
disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
|
a) |
|
all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
|
|
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 13, 2008 |
/s/ Don M. Bailey
|
|
|
Don M. Bailey |
|
|
Chief Executive Officer |
|
Certification
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, George Stuart, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Questcor Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the registrant and have:
|
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) |
|
designed such internal controls over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
|
|
c) |
|
evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
|
|
d) |
|
disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
|
a) |
|
all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
|
|
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 13, 2008 |
/s/ George Stuart
|
|
|
George Stuart |
|
|
Chief Financial Officer |
|
exv32
EXHIBIT 32
Certification
On
August 13, 2008, Questcor Pharmaceuticals, Inc. filed its Quarterly Report on Form 10-Q for
the quarter ended June 30, 2008 (the Form 10-Q) with the Securities and Exchange Commission.
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned hereby certify, to such persons knowledge, that:
(i) the Quarterly Report on Form 10-Q of the Company for the quarter ended June 30, 2008 (the
Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of
the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
|
|
|
|
|
|
|
|
Dated: August 13, 2008 |
/s/ Don M. Bailey
|
|
|
Don M. Bailey |
|
|
Chief Executive Officer |
|
|
|
|
|
|
/s/ George Stuart
|
|
|
George Stuart |
|
|
Chief Financial Officer |
|
|
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C.
§ 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, and is not to be incorporated by reference into any filing of the Company, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.