e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
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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 March 31, 2010
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: 001-14471
MEDICIS PHARMACEUTICAL CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware
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52-1574808 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
7720 North Dobson Road
Scottsdale, Arizona 85256-2740
(Address of principal executive offices)
(602) 808-8800
(Registrants telephone number, including area code)
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 period 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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes o 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.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
(do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2) Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
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Class |
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Outstanding at May 5, 2010 |
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Class A Common Stock $.014 Par Value |
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60,284,069 (a) |
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(a) |
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includes 2,036,491 shares of unvested restricted stock awards |
MEDICIS PHARMACEUTICAL CORPORATION
Table of Contents
Part I. Financial Information
Item 1. Financial Statements
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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March 31, 2010 |
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December 31, 2009 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
103,843 |
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$ |
209,051 |
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Short-term investments |
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454,622 |
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319,229 |
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Accounts receivable, net |
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109,950 |
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95,222 |
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Inventories, net |
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29,387 |
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25,985 |
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Deferred tax assets, net |
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66,574 |
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66,321 |
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Other current assets |
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19,776 |
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16,525 |
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Total current assets |
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784,152 |
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732,333 |
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Property and equipment, net |
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25,568 |
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25,247 |
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Net intangible assets |
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222,151 |
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227,840 |
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Goodwill |
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93,282 |
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93,282 |
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Deferred tax assets, net |
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58,454 |
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64,947 |
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Long-term investments |
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29,974 |
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25,524 |
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Other assets |
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3,025 |
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3,025 |
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$ |
1,216,606 |
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$ |
1,172,198 |
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See accompanying notes to condensed consolidated financial statements.
1
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
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March 31, 2010 |
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December 31, 2009 |
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(unaudited) |
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Liabilities |
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Current liabilities: |
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Accounts payable |
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$ |
47,698 |
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$ |
44,183 |
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Reserve for sales returns |
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43,716 |
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48,062 |
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Accrued consumer rebates and loyalty programs |
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94,582 |
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73,311 |
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Managed care and Medicaid reserves |
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48,964 |
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47,078 |
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Income taxes payable |
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15,824 |
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16,679 |
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Other current liabilities |
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59,186 |
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68,381 |
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Total current liabilities |
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309,970 |
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297,694 |
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Long-term liabilities: |
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Contingent convertible senior notes |
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169,326 |
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169,326 |
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Other liabilities |
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8,921 |
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9,919 |
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Stockholders Equity |
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Preferred stock, $0.01 par value; shares authorized: 5,000,000; no shares issued |
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Class A common stock, $0.014 par value; shares authorized: 150,000,000;
issued and outstanding: 71,073,076 and 70,732,409 at March 31, 2010 and December 31, 2009, respectively |
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986 |
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985 |
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Class B common stock, $0.014 par value; shares authorized: 1,000,000; issued and outstanding: none |
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Additional paid-in capital |
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693,801 |
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690,497 |
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Accumulated other comprehensive loss |
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(3,249 |
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(3,814 |
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Accumulated earnings |
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383,600 |
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351,842 |
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Less: Treasury stock, 12,859,425 and 12,749,261 shares
at cost at March 31, 2010 and December 31,
2009, respectively |
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(346,749 |
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(344,251 |
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Total stockholders equity |
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728,389 |
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695,259 |
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$ |
1,216,606 |
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$ |
1,172,198 |
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See accompanying notes to condensed consolidated financial statements.
2
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share data)
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Three Months Ended |
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March 31, 2010 |
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March 31, 2009 |
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Net product revenues |
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$ |
164,541 |
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$ |
96,600 |
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Net contract revenues |
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1,950 |
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3,219 |
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Net revenues |
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166,491 |
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99,819 |
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Cost of product revenues (1) |
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15,757 |
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9,446 |
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Gross profit |
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150,734 |
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90,373 |
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Operating expenses: |
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Selling, general and administrative (2) |
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75,948 |
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70,425 |
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Research and development (3) |
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10,164 |
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13,275 |
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Depreciation and amortization |
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7,053 |
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7,132 |
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Operating income (loss) |
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57,569 |
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(459 |
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Interest and investment income |
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(1,160 |
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(2,487 |
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Interest expense |
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1,058 |
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1,054 |
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Other expense, net |
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258 |
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2,873 |
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Income (loss) before income tax expense |
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57,413 |
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(1,899 |
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Income tax expense (benefit) |
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22,042 |
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(2,228 |
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Net income |
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$ |
35,371 |
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$ |
329 |
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Basic net income per share |
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$ |
0.59 |
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$ |
0.01 |
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Diluted net income per share |
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$ |
0.54 |
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$ |
0.01 |
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Cash dividend declared per common share |
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$ |
0.06 |
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$ |
0.04 |
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Common shares used in calculating: |
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Basic net income per share |
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58,049 |
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56,731 |
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Diluted net income per share |
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64,192 |
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56,867 |
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(1) amounts exclude amortization
of intangible assets related to
acquired products |
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$ |
5,351 |
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$ |
5,443 |
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(2) amounts include share-based
compensation expense |
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$ |
2,963 |
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$ |
3,733 |
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(3) amounts include share-based
compensation expense |
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$ |
132 |
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$ |
139 |
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See accompanying notes to condensed consolidated financial statements.
3
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Three Months Ended |
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March 31, 2010 |
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March 31, 2009 |
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Operating Activities: |
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Net income |
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$ |
35,371 |
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$ |
329 |
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Adjustments to reconcile net income to
net cash provided by operating activities: |
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Depreciation and amortization |
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7,053 |
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7,132 |
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Adjustment of impairment of available-for-sale investments |
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260 |
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(13 |
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Charge reducing value of investment in Revance |
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2,886 |
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Loss (gain) on sale of available-for-sale investments, net |
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34 |
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(10 |
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Share-based compensation expense |
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3,095 |
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3,872 |
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Deferred income tax benefit |
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6,011 |
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(10,680 |
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Tax expense from exercise of stock options and
vesting of restricted stock awards |
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47 |
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(644 |
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Excess tax benefits from share-based payment arrangements |
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(287 |
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Increase in provision for sales discounts and chargebacks |
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666 |
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144 |
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Accretion (amortization) of premium/(discount) on investments |
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826 |
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516 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(15,394 |
) |
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1,531 |
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Inventories |
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(3,401 |
) |
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(1,125 |
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Other current assets |
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(3,253 |
) |
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(1,203 |
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Accounts payable |
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3,515 |
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4,720 |
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Reserve for sales returns |
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(4,346 |
) |
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8,795 |
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Income taxes payable |
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(855 |
) |
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4,440 |
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Other current liabilities |
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9,553 |
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26,016 |
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Other liabilities |
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(998 |
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(1,308 |
) |
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Net cash provided by operating activities |
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37,897 |
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45,398 |
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Investing Activities: |
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Purchase of property and equipment |
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(1,958 |
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(1,875 |
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Payments for purchase of product rights |
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273 |
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(161 |
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Purchase of available-for-sale investments |
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(207,326 |
) |
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(74,264 |
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Sale of available-for-sale investments |
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12,782 |
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30,494 |
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Maturity of available-for-sale investments |
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54,215 |
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55,029 |
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Net cash (used in) provided by investing activities |
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(142,014 |
) |
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9,223 |
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Financing Activities: |
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Payment of dividends |
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(2,389 |
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(2,313 |
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Excess tax benefits from share-based payment arrangements |
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287 |
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Proceeds from the exercise of stock options |
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850 |
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Net cash used in financing activities |
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(1,252 |
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(2,313 |
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Effect of exchange rate on cash and cash equivalents |
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161 |
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74 |
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Net (decrease) increase in cash and cash equivalents |
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(105,208 |
) |
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52,382 |
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Cash and cash equivalents at beginning of period |
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209,051 |
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86,450 |
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Cash and cash equivalents at end of period |
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$ |
103,843 |
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$ |
138,832 |
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See accompanying notes to condensed consolidated financial statements.
4
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2010
(unaudited)
1. NATURE OF BUSINESS
Medicis Pharmaceutical Corporation (Medicis or the Company) is a leading specialty
pharmaceutical company focusing primarily on the development and marketing of products in the
United States (U.S.) for the treatment of dermatological and aesthetic conditions. Medicis also
markets products in Canada for the treatment of dermatological and aesthetic conditions and began
commercial efforts in Europe with the Companys acquisition of LipoSonix, Inc. (LipoSonix) in
July 2008.
The Company offers a broad range of products addressing various conditions or aesthetic
improvements including facial wrinkles, glabellar lines, acne, fungal infections, rosacea,
hyperpigmentation, photoaging, psoriasis, seborrheic dermatitis and cosmesis (improvement in the
texture and appearance of skin). Medicis currently offers 17 branded products. Its primary brands
are DYSPORT, PERLANE®, RESTYLANE®, SOLODYN®, TRIAZ®,
VANOS® and ZIANA®. Medicis entered the non-invasive body contouring market
with its acquisition of LipoSonix in July 2008.
The consolidated financial statements include the accounts of Medicis and its wholly owned
subsidiaries. The Company does not have any subsidiaries in which it does not own 100% of the
outstanding stock. All of the Companys subsidiaries are included in the consolidated financial
statements. All significant intercompany accounts and transactions have been eliminated in
consolidation.
The accompanying interim condensed consolidated financial statements of Medicis have been
prepared in conformity with U.S. generally accepted accounting principles, consistent in all
material respects with those applied in the Companys Annual Report on Form 10-K for the year ended
December 31, 2009. The financial information is unaudited, but reflects all adjustments,
consisting only of normal recurring adjustments and accruals, which are, in the opinion of the
Companys management, necessary to a fair statement of the results for the interim periods
presented. Interim results are not necessarily indicative of results for a full year. The
information included in this Form 10-Q should be read in conjunction with the Companys Annual
Report on Form 10-K for the year ended December 31, 2009.
2. SHARE-BASED COMPENSATION
Stock Option and Restricted Stock Awards
At March 31, 2010, the Company had seven active share-based employee compensation plans. Of
these seven share-based compensation plans, only the 2006 Incentive Award Plan is eligible for the
granting of future awards. Stock option awards granted from these plans are granted at the fair
market value on the date of grant. The option awards vest over a period determined at the time the
options are granted, ranging from one to five years, and generally have a maximum term of ten
years. Certain options provide for accelerated vesting if there is a change in control (as defined
in the plans). When options are exercised, new shares of the Companys Class A common stock are
issued.
The total value of the stock option awards is expensed ratably over the service period of the
employees receiving the awards. As of March 31, 2010, total unrecognized compensation cost related
to stock option awards, to be recognized as expense subsequent to March 31, 2010, was approximately
$1.4 million and the related weighted average period over which it is expected to be recognized is
approximately 2.6 years.
5
A summary of stock option activity within the Companys stock-based compensation plans and
changes for the three months ended March 31, 2010, is as follows:
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Weighted |
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Weighted |
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Average |
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Average |
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Remaining |
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Aggregate |
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Number |
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Exercise |
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Contractual |
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Intrinsic |
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of Shares |
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Price |
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Term |
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Value |
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Balance at December 31, 2009 |
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9,253,847 |
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$ |
29.24 |
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Granted |
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48,295 |
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$ |
22.69 |
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Exercised |
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(45,577 |
) |
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$ |
18.67 |
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Terminated/expired |
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(117,565 |
) |
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$ |
29.31 |
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Balance at March 31, 2010 |
|
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9,139,000 |
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$ |
29.26 |
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|
2.8 |
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$ |
8,488,913 |
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The intrinsic value of options exercised during the three months ended March 31, 2010,
was $282,612. Options exercisable under the Companys share-based compensation plans at March 31,
2010, were 8,793,300, with a weighted average exercise price of $29.54, a weighted average
remaining contractual term of 2.6 years, and an aggregate intrinsic value of $6,515,204.
A summary of outstanding and exercisable stock options that are fully vested and are expected
to vest, based on historical forfeiture rates, as of March 31, 2010, is as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
Outstanding, net of expected forfeitures |
|
|
8,357,777 |
|
|
$ |
29.38 |
|
|
|
2.8 |
|
|
$ |
7,534,338 |
|
Exercisable, net of expected forfeitures |
|
|
8,059,055 |
|
|
$ |
29.65 |
|
|
|
2.7 |
|
|
$ |
5,820,722 |
|
The fair value of each stock option award is estimated on the date of the grant using the
Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2010 |
|
|
March 31, 2009 |
|
|
Expected dividend yield |
|
|
1.06 |
% |
|
|
0.35 |
% |
Expected stock price volatility |
|
|
0.33 |
|
|
|
0.45 |
|
Risk-free interest rate |
|
|
3.04 |
% |
|
|
2.20 |
% |
Expected life of options |
|
7.0 Years |
|
7.0 Years |
The expected dividend yield is based on expected annual dividends to be paid by the Company as
a percentage of the market value of the Companys stock as of the date of grant. The Company
determined that a blend of implied volatility and historical volatility is more reflective of
market conditions and a better indicator of expected volatility than using purely historical
volatility. The risk-free interest rate is based on the U.S. treasury security rate in effect as
of the date of grant. The expected lives of options are based on historical data of the Company.
The weighted average fair value of stock options granted during the three months ended March
31, 2010 and 2009, was $8.10 and $5.32, respectively.
6
The Company also grants restricted stock awards to certain employees. Restricted stock awards
are valued at the closing market value of the Companys Class A common stock on the date of grant,
and the total value of the award is expensed ratably over the service period of the employees
receiving the grants. During the three months ended March 31, 2010, 511,235 shares of restricted
stock were granted to certain employees. Share-based compensation expense related to all
restricted stock awards outstanding during the three months ended March 31, 2010 and 2009, was
approximately $1.9 million and $1.8 million, respectively. As of March 31, 2010, the total amount
of unrecognized compensation cost related to nonvested restricted stock awards, to be recognized as
expense subsequent to March 31, 2010, was approximately $33.0 million, and the related weighted
average period over which it is expected to be recognized is approximately 3.3 years.
A summary of restricted stock activity within the Companys share-based compensation plans and
changes for the three months ended March 31, 2010, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
Nonvested Shares |
|
Shares |
|
|
Fair Value |
|
|
Nonvested at December 31, 2009 |
|
|
1,915,469 |
|
|
$ |
17.12 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
511,235 |
|
|
$ |
22.69 |
|
Vested |
|
|
(295,090 |
) |
|
$ |
18.26 |
|
Forfeited |
|
|
(31,717 |
) |
|
$ |
23.59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2010 |
|
|
2,099,897 |
|
|
$ |
18.22 |
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the three months ended March 31, 2010
and 2009, was approximately $5.4 million and $2.6 million, respectively.
Stock Appreciation Rights
During 2009, the Company began granting cash-settled stock appreciation rights (SARs) to
many of its employees. SARs generally vest over a graduated five-year period and expire seven
years from the date of grant, unless such expiration occurs sooner due to the employees
termination of employment, as provided in the applicable SAR award agreement. SARs allow the
holder to receive cash (less applicable tax withholding) upon the holders exercise, equal to the
excess, if any, of the market price of the Companys Class A common stock on the exercise date over
the exercise price, multiplied by the number of shares relating to the SAR with respect to which
the SAR is exercised. The exercise price of the SAR is the fair market value of a share of the
Companys Class A common stock relating to the SAR on the date of grant. The total value of the
SARs is expensed over the service period of the employees receiving the grants, and a liability is
recognized in the Companys condensed consolidated balance sheets until settled. The fair value of
SARs is required to be remeasured at the end of each reporting period until the award is settled,
and changes in fair value must be recognized as compensation expense to the extent of vesting each
reporting period based on the new fair value. Share-based compensation expense related to SARs
during the three months ended March 31, 2010 and 2009, was approximately $0.7 million and $0.2
million, respectively. As of March 31, 2010, the total measured amount of unrecognized
compensation cost related to outstanding SARs, to be recognized as expense subsequent to March 31,
2010, was approximately $33.5 million, and the related weighted average period over which it is
expected to be recognized is approximately 4.4 years.
7
The fair value of each SAR was estimated on the date of the grant, and was remeasured at
quarter-end, using the Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SARs Granted During |
|
SARs Granted During |
|
Remeasurement |
|
|
|
|
|
|
Three Months Ended |
|
Three Months Ended |
|
as of |
|
|
|
|
|
|
March 31, 2010 |
|
March 31, 2009 |
|
March 31, 2010 |
|
|
|
|
|
Expected dividend yield |
|
|
1.06 |
% |
|
|
0.35 |
% |
|
|
0.95 |
% |
|
|
|
|
Expected stock price volatility |
|
|
0.33 |
|
|
|
0.45 |
|
|
|
0.32 |
|
|
|
|
|
Risk-free interest rate |
|
|
3.04 |
% |
|
|
2.20 |
% |
|
|
3.28 |
% |
|
|
|
|
Expected life of SARs |
|
7.0 Years |
|
7.0 Years |
|
6.4 Years |
|
|
|
|
The weighted average fair value of SARs granted during the three months ended March 31,
2010 and 2009, as of the respective grant dates, was $8.10 and $5.32, respectively. The weighted
average fair value of all SARs outstanding as of the remeasurement date of March 31, 2010 was
$12.80.
A summary of SARs activity for the three months ended March 31, 2010, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of SARs |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
Balance at December 31, 2009 |
|
|
1,916,156 |
|
|
$ |
11.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,333,176 |
|
|
$ |
22.69 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(13,359 |
) |
|
$ |
11.38 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(152,857 |
) |
|
$ |
12.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2010 |
|
|
3,083,116 |
|
|
$ |
16.25 |
|
|
|
6.4 |
|
|
$ |
27,477,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2010, 174,044 SARs were exercisable, with a weighted average exercise price of
$11.29, a weighted average remaining contractual term of 5.9 years, and an aggregate intrinsic
value of $2,413,230.
3. SHORT-TERM AND LONG-TERM INVESTMENTS
The Companys policy for its short-term and long-term investments is to establish a
high-quality portfolio that preserves principal, meets liquidity needs, avoids inappropriate
concentrations and delivers an appropriate yield in relationship to the Companys investment
guidelines and market conditions. Short-term and long-term investments consist of corporate and
various government agency and municipal debt securities. The Companys investments in auction rate
floating securities consist of investments in student loans. Management classifies the Companys
short-term and long-term investments as available-for-sale. Available-for-sale securities are
carried at fair value with unrealized gains and losses reported in stockholders equity. Realized
gains and losses and declines in value judged to be other than temporary, if any, are included in
other expense in the condensed consolidated statement of operations. A decline in the market value
of any available-for-sale security below cost that is deemed to be other than temporary, results in
impairment of the fair value of the investment. The impairment is charged to earnings and a new
cost basis for the security is established. Premiums and discounts are amortized or accreted over
the life of the related available-for-sale security. Dividends and interest income are recognized
when earned. The cost of securities sold is calculated using the specific identification method.
At March 31, 2010, the Company has recorded the estimated fair value of available-for-sale and
trading securities in short-term and long-term investments of approximately $454.6 million and
$30.0 million, respectively.
8
Available-for-sale and trading securities consist of the following at March 31, 2010 (amounts
in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other-Than- |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Temporary |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Impairment |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Losses |
|
|
Value |
|
|
Corporate notes and bonds |
|
$ |
135,285 |
|
|
$ |
590 |
|
|
$ |
(90 |
) |
|
$ |
|
|
|
$ |
135,785 |
|
Federal agency notes and bonds |
|
|
320,250 |
|
|
|
363 |
|
|
|
(165 |
) |
|
|
|
|
|
|
320,448 |
|
Auction rate floating securities |
|
|
34,400 |
|
|
|
|
|
|
|
(8,146 |
) |
|
|
|
|
|
|
26,254 |
|
Asset-backed securities |
|
|
2,354 |
|
|
|
15 |
|
|
|
|
|
|
|
(260 |
) |
|
|
2,109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
492,289 |
|
|
$ |
968 |
|
|
$ |
(8,401 |
) |
|
$ |
(260 |
) |
|
$ |
484,596 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three months ended March 31, 2010, the gross realized gains and losses on
sales of available-for-sale securities were $0. Gross unrealized gains and losses are determined
based on the specific identification method. The net adjustment to unrealized gains during the
three months ended March 31, 2010, on available-for-sale securities included in stockholders
equity totaled $0.2 million. The amortized cost and estimated fair value of the available-for-sale
securities at March 31, 2010, by maturity, are shown below (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
200,959 |
|
|
$ |
200,936 |
|
Due after one year through five years |
|
|
256,931 |
|
|
|
257,406 |
|
Due after 10 years |
|
|
33,100 |
|
|
|
24,956 |
|
|
|
|
|
|
|
|
|
|
$ |
490,990 |
|
|
$ |
483,298 |
|
|
|
|
|
|
|
|
Expected maturities will differ from contractual maturities because the issuers of the
securities may have the right to prepay obligations without prepayment penalties, and the Company
views its available-for-sale securities as available for current operations. At March 31, 2010,
approximately $30.0 million in estimated fair value expected to mature greater than one year has
been classified as long-term investments since these investments are in an unrealized loss
position, and management has both the ability and intent to hold these investments until recovery
of fair value, which may be maturity.
As of March 31, 2010, the Companys investments included auction rate floating securities with
a fair value of $26.3 million. The Companys auction rate floating securities are debt instruments
with a long-term maturity and with an interest rate that is reset in short intervals through
auctions. The negative conditions in the credit markets during 2008, 2009 and the first quarter of
2010 have prevented some investors from liquidating their holdings, including their holdings of
auction rate floating securities. During the three months ended March 31, 2008, the Company was
informed that there was insufficient demand at auction for the auction rate floating securities.
As a result, these affected auction rate floating securities are now considered illiquid, and the
Company could be required to hold them until they are redeemed by the holder at maturity. The
Company may not be able to liquidate the securities until a future auction on these investments is
successful.
In November 2008, the Company entered into a settlement agreement with the broker through
which the Company purchased auction rate floating securities. The settlement agreement provides
the Company with the right to put an auction rate floating security currently held by the Company
back to the broker beginning on June 30, 2010. At March 31, 2010 and December 31, 2009, the
Company held one auction rate floating security with a par value of $1.3 million that was subject
to the settlement agreement. At inception, the Company elected the irrevocable Fair Value
9
Option treatment under ASC 825, Financial Instruments, and accordingly adjusts the put option
to fair value at each reporting date. Concurrent with the execution of the settlement agreement,
the Company reclassified this auction rate floating security from available-for-sale to trading
securities and accordingly, future changes in fair value related to this investment and the related
put option will be recorded in earnings.
During the three months ended March 31, 2010, the Company became aware of new circumstances
that directly impacted the valuation of an asset-backed security that is owned by the Company. An
unrealized loss on the asset-backed security, based on the Companys intent to hold the security
until recovery of the fair value, had previously been recorded in stockholders equity. Based on
the new circumstances related to the investment, the Company determined that the impairment of the
asset-backed security was other-than-temporary, as the Company believed it would not recover its
investment even if the asset were held to maturity. A $0.3 million impairment charge was therefore
recorded in other expense, net, during the three months ended March 31, 2010 related to the
asset-backed security. The asset-backed security was sold in April 2010.
The following table shows the gross unrealized losses and the fair value of the Companys
investments, with unrealized losses that are not deemed to be other-than-temporarily impaired
aggregated by investment category and length of time that individual securities have been in a
continuous unrealized loss position at March 31, 2010 (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
|
Greater Than 12 Months |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
|
Corporate notes and bonds |
|
$ |
53,959 |
|
|
$ |
90 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and
bonds |
|
|
129,754 |
|
|
|
165 |
|
|
|
|
|
|
|
|
|
Auction rate floating
securities |
|
|
|
|
|
|
|
|
|
|
26,254 |
|
|
|
8,146 |
|
Asset-backed securities |
|
|
|
|
|
|
|
|
|
|
1,150 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
183,713 |
|
|
$ |
255 |
|
|
$ |
27,404 |
|
|
$ |
8,146 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2010, the Company has concluded that the unrealized losses on its investment
securities are temporary in nature and are caused by changes in credit spreads and liquidity issues
in the marketplace. Available-for-sale securities are reviewed quarterly for possible
other-than-temporary impairment. This review includes an analysis of the facts and circumstances
of each individual investment such as the severity of loss, the length of time the fair value has
been below cost, the expectation for that securitys performance and the creditworthiness of the
issuer. Additionally, the Company does not intend to sell and it is
not more likely than not that the Company will be required to sell
any of the securities before the recovery of their amortized cost
basis.
4. FAIR VALUE MEASUREMENTS
As of March 31, 2010, the Company held certain assets that are required to be measured at fair
value on a recurring basis. These included certain of the Companys short-term and long-term
investments, including investments in auction rate floating securities, and the Companys
investment in Hyperion Therapeutics, Inc. (Hyperion).
The Company has invested in auction rate floating securities, which are classified as
available-for-sale or trading securities and reflected at fair value. Due to events in credit
markets, the auction events for some of these instruments held by the Company failed during the
three months ended March 31, 2008 (see Note 3). Therefore, the fair values of these auction rate
floating securities, which are primarily rated AAA, are estimated utilizing a discounted cash flow
analysis as of March 31, 2010. These analyses consider, among other items, the collateralization
underlying the security investments, the creditworthiness of the counterparty, the timing of
expected future cash flows, and the expectation of the next time the security is expected to have a
successful auction. These investments were also compared, when possible, to other observable
market data with similar
10
characteristics to the securities held by the Company. Changes to these
assumptions in future periods could result in additional declines in fair value of the auction rate
floating securities.
The Companys assets measured at fair value on a recurring basis subject to the disclosure
requirements of ASC 820, Fair Value Measurements and Disclosures, at March 31, 2010, were as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at Reporting Date Using |
|
|
|
|
|
|
|
Quoted |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Prices in |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
|
Active |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
|
Markets |
|
|
Inputs |
|
|
Inputs |
|
|
|
Mar. 31, 2010 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Corporate notes and bonds |
|
$ |
135,785 |
|
|
$ |
135,785 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and bonds |
|
|
320,448 |
|
|
|
320,448 |
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
26,254 |
|
|
|
|
|
|
|
|
|
|
|
26,254 |
|
Asset-backed securities |
|
|
2,109 |
|
|
|
2,109 |
|
|
|
|
|
|
|
|
|
Investment in Hyperion |
|
|
2,375 |
|
|
|
|
|
|
|
|
|
|
|
2,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
486,971 |
|
|
$ |
458,342 |
|
|
$ |
|
|
|
$ |
28,629 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents the Companys assets measured at fair value on a recurring
basis using significant unobservable inputs (Level 3) for the three months ended March 31, 2010 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements |
|
|
|
Using Significant Unobservable |
|
|
|
Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
Investment |
|
|
|
Floating |
|
|
in |
|
|
|
Securities |
|
|
Hyperion |
|
|
Balance at December 31, 2009 |
|
$ |
26,821 |
|
|
$ |
2,375 |
|
Total gains (losses) included in other
expense, net |
|
|
|
|
|
|
|
|
Total gains
included in other comprehensive income |
|
|
33 |
|
|
|
|
|
Purchases and settlements, net |
|
|
(600 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2010 |
|
$ |
26,254 |
|
|
$ |
2,375 |
|
|
|
|
|
|
|
|
5. INVESTMENT IN REVANCE
On December 11, 2007, the Company announced a strategic collaboration with Revance, a
privately-held, venture-backed development-stage entity, whereby the Company made an equity
investment in Revance and purchased an option to acquire Revance or to license exclusively in North
America Revances novel topical botulinum toxin type A product currently under clinical
development. The consideration to be paid to Revance upon the Companys exercise of the option
will be at an amount that will approximate the then fair value of Revance or the license of the
product under development, as determined by an independent appraisal. The option period will
extend through the end of Phase 2 testing in the United States. In consideration for the Companys
$20.0 million payment, the Company received preferred stock representing an approximate 13.7
percent ownership in Revance, or approximately 11.7 percent on a fully diluted basis, and the
option to acquire Revance or to license the product under development. The $20.0 million was used
by Revance primarily for the development of the product. Approximately $12.0 million of the $20.0
million payment represented the fair value of the investment in Revance at the time of the
investment and was included in other long-term assets in the Companys condensed consolidated
balance sheets as of December 31, 2007. The remaining $8.0 million, which is non-refundable and
was expected to
11
be utilized in the development of the new product, represented the residual value
of the option to acquire Revance or to license the product under development and was recognized as research and development
expense during the three months ended December 31, 2007.
Prior to the exercise of the option, Revance will remain primarily responsible for the
worldwide development of Revances topical botulinum toxin type A product in consultation with the
Company in North America. The Company will assume primary responsibility for the development of
the product should consummation of either a merger or a license for topically delivered botulinum
toxin type A in North America be completed under the terms of the option. Revance will have sole
responsibility for manufacturing the development product and manufacturing the product during
commercialization worldwide. The Companys right to exercise the option is triggered upon
Revances successful completion of certain regulatory milestones through the end of Phase 2 testing
in the U.S. A license would contain a payment upon exercise of the license option, milestone
payments related to clinical, regulatory and commercial achievements, and royalties based on sales
defined in the license. If the Company elects to exercise the option, the financial terms for the
acquisition or license will be determined through an independent valuation in accordance with
specified methodologies.
The Company estimated the impairment and/or the net realizable value of the investment based
on a hypothetical liquidation at book value approach as of the reporting date, unless a
quantitative valuation metric was available for these purposes (such as the completion of an equity
financing by Revance). During the three months ended March 31, 2009, the Company reduced the
carrying value of its investment in Revance by approximately $2.9 million, as a result of a
reduction in the estimated net realizable value of the investment using the hypothetical
liquidation at book value approach. Such amount was recognized in other (income) expense. As a
result of this reduction, the Companys investment in Revance as of March 31, 2009 was $0. As of
March 31, 2010, the Companys investment in Revance related to this transaction was $0.
A business entity is subject to consolidation rules and is referred to as a variable interest
entity if it lacks sufficient equity to finance its activities without additional financial support
from other parties or its equity holders lack adequate decision making ability based on certain
criteria. Disclosures are required about variable interest entities that a company is not required
to consolidate, but in which a company has a significant variable interest. The Company has
determined that Revance is a variable interest entity and that the Company is not the primary
beneficiary, and therefore the Companys equity investment in Revance currently does not require
the Company to consolidate Revance into its financial statements. The consolidation status could
change in the future, however, depending on changes in the Companys relationship with Revance.
6. STRATEGIC COLLABORATIONS
On November 26, 2008, the Company entered into a License and Settlement Agreement and a Joint
Development Agreement with IMPAX Laboratories, Inc. (IMPAX). In connection with the License and
Settlement Agreement, the Company and IMPAX agreed to terminate all legal disputes between them
relating to SOLODYN®. Additionally, under terms of the License and Settlement
Agreement, IMPAX confirmed that the Companys patents relating to SOLODYN® are valid and
enforceable, and cover IMPAXs activities relating to its generic product under ANDA #09-024.
Under the terms of the License and Settlement Agreement, IMPAX has a license to market its
generic versions of SOLODYN® 45mg, 90mg and 135mg under the SOLODYN® patent
rights belonging to the Company upon the occurrence of specific events. Upon launch of its generic
formulations of SOLODYN®, IMPAX may be required to pay the Company a royalty, based on
sales of those generic formulations by IMPAX under terms described in the License and Settlement
Agreement.
Under the Joint Development Agreement, the Company and IMPAX will collaborate on the
development of five strategic dermatology product opportunities, including an advanced-form
SOLODYN® product. Under terms of the agreement, the Company made an initial payment of
$40.0 million upon execution of the agreement. During the three months ended March 31, 2009,
September 30, 2009 and December 31, 2009, the Company paid IMPAX $5.0 million, $5.0 million and
$2.0 million, respectively, upon the achievement of three separate clinical milestones, in
accordance with terms of the agreement. In addition, the Company will be required to pay up to
$11.0 million upon successful completion of certain other clinical and commercial milestones. The
Company will also make royalty payments based on sales of the advanced-form SOLODYN®
product if and when it is commercialized by the
12
Company upon approval by the FDA. The Company will
share equally in the gross profit of the other four development products if and when they are
commercialized by IMPAX upon approval by the FDA.
The $40.0 million initial payment was recognized as a charge to research and development
expense during 2008, and the $5.0 million, $5.0 million and $2.0 million clinical milestone
achievement payments were recognized as a charge to research and development expense during the
three months ended March 31, 2009, September 30, 2009 and December 31, 2009, respectively.
7. SEGMENT AND PRODUCT INFORMATION
The Company operates in one significant business segment: pharmaceuticals. The Companys
current pharmaceutical franchises are divided between the dermatological and non-dermatological
fields. The dermatological field represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological conditions. The non-dermatological field
represents products for the treatment of urea cycle disorder, non-invasive body sculpting
technology and contract revenue. The acne and acne-related dermatological product lines include
DYNACIN®, PLEXION®, SOLODYN®, TRIAZ® and
ZIANA®. The non-acne dermatological product lines include DYSPORTTM,
LOPROX®, PERLANE®, RESTYLANE® and VANOS®. The
non-dermatological product lines include AMMONUL®, BUPHENYL® and the
LIPOSONIXTM system. The non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generics.
The Companys pharmaceutical products, with the exception of AMMONUL® and
BUPHENYL®, are promoted to dermatologists, podiatrists, and plastic surgeons. Such
products are often prescribed by physicians outside these three specialties; including family
practitioners, general practitioners, primary-care physicians and OB/GYNs, as well as hospitals,
government agencies, and others. Currently, the Companys products are sold primarily to
wholesalers and retail chain drug stores.
Net revenues and the percentage of net revenues for each of the product categories are as
follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Acne and acne-related dermatological products |
|
$ |
120,213 |
|
|
$ |
66,453 |
|
Non-acne dermatological products |
|
|
34,252 |
|
|
|
23,473 |
|
Non-dermatological products |
|
|
12,026 |
|
|
|
9,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
166,491 |
|
|
$ |
99,819 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Acne and acne-related
dermatological products |
|
|
72 |
% |
|
|
67 |
% |
Non-acne dermatological products |
|
|
21 |
|
|
|
23 |
|
Non-dermatological products |
|
|
7 |
|
|
|
10 |
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
8. INVENTORIES
The Company primarily utilizes third parties to manufacture and package inventories held for
sale, takes title to certain inventories once manufactured, and warehouses such goods until
packaged for final distribution and sale. Inventories consist of salable products held at the
Companys warehouses, as well as raw materials and components at the manufacturers facilities, and
are valued at the lower of cost or market using the first-in, first-out method. The
13
Company provides valuation reserves for estimated obsolescence or unmarketable inventory in an amount equal
to the difference between the cost of inventory and the estimated market value based upon
assumptions about future demand and market conditions.
Inventory costs associated with products that have not yet received regulatory approval are
capitalized if, in the view of the Companys management, there is probable future commercial use
and future economic benefit. If future commercial use and future economic benefit are not
considered probable, then costs associated with pre-launch inventory that has not yet received
regulatory approval are expensed as research and development expense during the period the costs
are incurred. As of March 31, 2010 and December 31, 2009, there was $0.3 million of costs
capitalized into inventory for products that have not yet received regulatory approval.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
December 31, 2009 |
|
|
Raw materials |
|
$ |
8,290 |
|
|
$ |
7,472 |
|
Work-in-process |
|
|
2,728 |
|
|
|
3,660 |
|
Finished goods |
|
|
24,982 |
|
|
|
21,087 |
|
Valuation reserve |
|
|
(6,613 |
) |
|
|
(6,234 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
29,387 |
|
|
$ |
25,985 |
|
|
|
|
|
|
|
|
Selling, general and administrative costs capitalized into inventory during the three months
ended March 31, 2010 and 2009 was $0.4 million and $0.4 million, respectively. Selling, general
and administrative expenses included in inventory as of March 31, 2010 and December 31, 2009 was
$1.3 million and $1.2 million, respectively.
9. OTHER CURRENT LIABILITIES
Other current liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
December 31, 2009 |
|
|
Accrued incentives, including SARs liability |
|
$ |
16,005 |
|
|
$ |
26,671 |
|
Deferred revenue |
|
|
17,705 |
|
|
|
18,508 |
|
Other accrued expenses |
|
|
25,476 |
|
|
|
23,202 |
|
|
|
|
|
|
|
|
|
|
$ |
59,186 |
|
|
$ |
68,381 |
|
|
|
|
|
|
|
|
Included in deferred revenue as of March 31, 2010 and December 31, 2009, was $12.2 million and
$15.4 million, respectively, associated with the deferral of revenue of our aesthetics products,
including RESTYLANE®, PERLANE® and DYSPORTTM, until our exclusive
U.S. distributor ships the product to physicians.
10. CONTINGENT CONVERTIBLE SENIOR NOTES
In June 2002, the Company sold $400.0 million aggregate principal amount of its 2.5%
Contingent Convertible Senior Notes Due 2032 (the Old Notes) in private transactions. As
discussed below, approximately $230.8 million in principal amount of the Old Notes was exchanged
for New Notes on August 14, 2003. The Old Notes bear interest at a rate of 2.5% per annum, which
is payable on June 4 and December 4 of each year, beginning on December 4, 2002. The Company also
agreed to pay contingent interest at a rate equal to 0.5% per annum during any six-month period,
with the initial six-month period commencing June 4, 2007, if the average trading price of the Old
Notes reaches certain thresholds. No contingent interest related to the Old Notes was payable at
March 31, 2010 or December 31, 2009. The Old Notes will mature on June 4, 2032.
The Company may redeem some or all of the Old Notes at any time on or after June 11, 2007, at
a redemption price, payable in cash, of 100% of the principal amount of the Old Notes, plus accrued
and unpaid interest, including contingent interest, if any. Holders of the Old Notes may require
the Company to repurchase all or a portion of their Old Notes on June 4, 2012 and June 4, 2017, or
upon a change in control, as defined in the
14
indenture governing the Old Notes, at 100% of the principal amount of the Old Notes, plus accrued and unpaid interest to the date of the repurchase,
payable in cash. Under GAAP, if an obligation is due on demand or will be due on demand within one
year from the balance sheet date, even though liquidation may not be expected within that period,
it should be classified as a current liability. Accordingly, the outstanding balance of Old Notes
along with the deferred tax liability associated with accelerated interest deductions on the Old Notes
will be classified as a current liability during the respective twelve month periods prior to June
4, 2012 and June 4, 2017.
The Old Notes are convertible, at the holders option, prior to the maturity date into shares
of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after June 30, 2002, if the closing price of the Companys
Class A common stock over a specified number of trading days during the previous quarter,
including the last trading day of such quarter, is more than 110% of the conversion price
of the Old Notes, or $31.96. The Old Notes are initially convertible at a conversion price
of $29.05 per share, which is equal to a conversion rate of approximately 34.4234 shares
per $1,000 principal amount of Old Notes, subject to adjustment; |
|
|
|
|
if the Company has called the Old Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the Old Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
Old Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The Old Notes, which are unsecured, do not contain any restrictions on the payment of
dividends, the incurrence of additional indebtedness or the repurchase of the Companys securities
and do not contain any financial covenants.
The Company incurred $12.6 million of fees and other origination costs related to the issuance
of the Old Notes. The Company amortized these costs over the first five-year Put period, which ran
through June 4, 2007.
On August 14, 2003, the Company exchanged approximately $230.8 million in principal amount of
its Old Notes for approximately $283.9 million in principal amount of its 1.5% Contingent
Convertible Senior Notes Due 2033 (the New Notes). Holders of Old Notes that accepted the
Companys exchange offer received $1,230 in principal amount of New Notes for each $1,000 in
principal amount of Old Notes. The terms of the New Notes are similar to the terms of the Old
Notes, but have a different interest rate, conversion rate and maturity date. Holders of Old Notes
that chose not to exchange continue to be subject to the terms of the Old Notes.
The New Notes bear interest at a rate of 1.5% per annum, which is payable on June 4 and
December 4 of each year, beginning December 4, 2003. The Company will also pay contingent interest
at a rate of 0.5% per annum during any six-month period, with the initial six-month period
commencing June 4, 2008, if the average trading price of the New Notes reaches certain thresholds.
No contingent interest related to the New Notes was payable at March 31, 2010 or December 31, 2009.
The New Notes mature on June 4, 2033.
As a result of the exchange, the outstanding principal amounts of the Old Notes and the New
Notes were $169.2 million and $283.9 million, respectively. The Company incurred approximately
$5.1 million of fees and other origination costs related to the issuance of the New Notes. The
Company amortized these costs over the first five-year Put period, which ran through June 4, 2008.
Holders of the New Notes were able to require the Company to repurchase all or a portion of
their New Notes on June 4, 2008, at 100% of the principal amount of the New Notes, plus accrued and
unpaid interest, including contingent interest, if any, to the date of the repurchase, payable in
cash. Holders of approximately $283.7 million of New Notes elected to require the Company to
repurchase their New Notes on June 4, 2008. The Company paid $283.7 million, plus accrued and
unpaid interest of approximately $2.2 million, to the holders of New Notes that elected to require
the Company to repurchase their New Notes. The Company was also required to pay an accumulated
deferred tax liability of approximately $34.9 million related to the repurchased New Notes. This
15
$34.9 million deferred tax liability was paid during the second half of 2008. Following the
repurchase of these New Notes, $181,000 of principal amount of New Notes remained outstanding as of
March 31, 2010 and December 31, 2009.
The remaining New Notes are convertible, at the holders option, prior to the maturity date
into shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after September 30, 2003, if the closing price of the
Companys Class A common stock over a specified number of trading days during the previous
quarter, including the last trading day of such quarter, is more than 120% of the
conversion price of the New Notes, or $46.51. The Notes are initially convertible at a
conversion price of $38.76 per share, which is equal to a conversion rate of approximately
25.7998 shares per $1,000 principal amount of New Notes, subject to adjustment; |
|
|
|
|
if the Company has called the New Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the New Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
New Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The remaining New Notes, which are unsecured, do not contain any restrictions on the
incurrence of additional indebtedness or the repurchase of the Companys securities and do not
contain any financial covenants. The New Notes require an adjustment to the conversion price if
the cumulative aggregate of all current and prior dividend increases above $0.025 per share would
result in at least a one percent (1%) increase in the conversion price. This threshold has not
been reached and no adjustment to the conversion price has been made.
During the quarters ended March 31, 2010 and December 31, 2009, the Old Notes and New Notes
did not meet the criteria for the right of conversion. At the end of each future quarter, the
conversion rights will be reassessed in accordance with the bond indenture agreement to determine
if the conversion trigger rights have been achieved.
11. INCOME TAXES
Income taxes are determined using an annual effective tax rate, which generally differs from
the U.S. Federal statutory rate, primarily because of state and local income taxes, enhanced
charitable contribution deductions for inventory, tax credits available in the U.S., the treatment
of certain share-based payments that are not designed to normally result in tax deductions, various
expenses that are not deductible for tax purposes, changes in valuation allowances against deferred
tax assets and differences in tax rates in certain non-U.S. jurisdictions. The Companys effective
tax rate may be subject to fluctuations during the year as new information is obtained which may
affect the assumptions it uses to estimate its annual effective tax rate, including factors such as
its mix of pre-tax earnings in the various tax jurisdictions in which it operates, changes in
valuation allowances against deferred tax assets, reserves for tax audit issues and settlements,
utilization of tax credits and changes in tax laws in jurisdictions where the Company conducts
operations. The Company recognizes tax benefits only if the tax position is more likely than not
of being sustained. The Company recognizes deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax basis of its assets and liabilities,
along with net operating losses and credit carryforwards. The Company records valuation allowances
against its deferred tax assets to reduce the net carrying value to amounts that management
believes is more likely than not to be realized.
At March 31, 2010, the Company has an unrealized tax loss of $21.0 million related to the
Companys option to acquire Revance or license Revances topical product that is under development.
The Company will not be able to determine the character of the loss until the Company exercises or
fails to exercise its option. A realized loss characterized as a capital loss can only be utilized
to offset capital gains. At March 31, 2010, the Company has recorded a valuation allowance of $7.6
million against the deferred tax asset associated with this unrealized tax loss
16
in order to reduce the carrying value of the deferred tax asset to $0, which is the amount that management believes is
more likely than not to be realized.
During the three months ended March 31, 2010 and March 31, 2009, the Company made net tax
payments of $16.8 million and $1.5 million, respectively.
The Company operates in multiple tax jurisdictions and is periodically subject to audit in
these jurisdictions. These audits can involve complex issues that may require an extended period
of time to resolve and may cover multiple years. The Company and its domestic subsidiaries file a
consolidated U.S. federal income tax return. Such returns have either been audited or settled
through statute expiration through 2005. The state of California is currently conducting an
examination on the Companys tax returns for the periods ending June 30, 2005, December 31, 2005,
December 31, 2006 and December 31, 2007.
The Company owns two subsidiaries that file corporate tax returns in Sweden. The Swedish tax
authorities examined the tax return of one of the subsidiaries for fiscal 2004. The examiners
issued a no change letter, and the examination is complete. The Companys other subsidiary in
Sweden has not been examined by the Swedish tax authorities. The Swedish statute of limitation may
be open for up to five years from the date the tax return was filed. Thus, all returns filed from
fiscal 2005 forward are open under the statute of limitation.
At March 31, 2010 and December 31, 2009, the Company had $2.3 million in unrecognized tax
benefits, the recognition of which would have a favorable effect of $1.7 million on the Companys
effective tax rate. During the next twelve months, the Company estimates that it is reasonably
possible that the amount of unrecognized tax benefits will decrease by $0.8 million due to normal
statute closures.
The Company recognizes accrued interest and penalties, if applicable, related to unrecognized
tax benefits in income tax expense. The Company had approximately $0.5 million for the payment of
interest and penalties accrued (net of tax benefit) at March 31, 2010 and December 31, 2009.
12. DIVIDENDS DECLARED ON COMMON STOCK
On March 10, 2010, the Company declared a cash dividend of $0.06 per issued and outstanding
share of its Class A common stock payable on April 30, 2010, to stockholders of record at the close
of business on April 1, 2010. The $3.6 million dividend was recorded as a reduction of accumulated
earnings and is included in other current liabilities in the accompanying condensed consolidated
balance sheets as of March 31, 2010. The Company has not adopted a dividend policy.
13. COMPREHENSIVE INCOME
Total comprehensive income includes net income and other comprehensive income (loss), which
consists of foreign currency translation adjustments and unrealized gains and losses on
available-for-sale investments. Total comprehensive income for the three months ended March 31,
2010 and 2009, was $35.9 million and $0.3 million, respectively.
17
14. NET INCOME PER COMMON SHARE
The following table sets forth the computation of basic and diluted net income per common
share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, 2010 |
|
|
March 31, 2009 |
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
35,371 |
|
|
$ |
329 |
|
|
|
|
|
|
|
|
|
|
Less: income allocated to participating securities |
|
|
1,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stockholders |
|
|
34,208 |
|
|
|
329 |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
58,049 |
|
|
|
56,731 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share |
|
$ |
0.59 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
35,371 |
|
|
$ |
329 |
|
|
|
|
|
|
|
|
|
|
Less: income allocated to participating securities |
|
|
1,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stockholders |
|
|
34,208 |
|
|
|
329 |
|
|
|
|
|
|
|
|
|
|
Less: |
|
|
|
|
|
|
|
|
Undistributed earnings allocated to unvested stockholders |
|
|
(1,057 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
Undistributed earnings re-allocated to unvested stockholders |
|
|
1,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
Tax-effected interest expense and issue costs related to Old Notes |
|
|
666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income assuming dilution |
|
$ |
34,868 |
|
|
$ |
329 |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
58,049 |
|
|
|
56,731 |
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
|
|
New Notes |
|
|
4 |
|
|
|
|
|
Stock options |
|
|
316 |
|
|
|
90 |
|
Unvested restricted stock |
|
|
|
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares assuming dilution |
|
|
64,192 |
|
|
|
56,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share |
|
$ |
0.54 |
|
|
$ |
0.01 |
|
|
|
|
|
|
|
|
Diluted net income per common share must be calculated using the if-converted method.
Diluted net income per share using the if-converted method is calculated by adjusting net income
for tax-effected net interest and issue costs on the Old Notes and New Notes, divided by the
weighted average number of common shares outstanding assuming conversion.
18
Unvested share-based payment awards that contain rights to receive nonforfeitable dividends or
dividend equivalents (whether paid or unpaid) are participating securities, and thus, are included
in the two-class method of computing earnings per share. The two-class method is an earnings
allocation formula that treats a participating security as having rights to earnings that would
otherwise have been available to common stockholders. Restricted stock granted to certain
employees by the Company (see Note 2) participate in dividends on the same basis as common shares,
and these dividends are not forfeitable by the holders of the restricted stock. As a result, the
restricted stock grants meet the definition of a participating security.
The diluted net income per common share computation for the three months ended March 31, 2010
and 2009, excludes 8,483,156 and 12,106,591 shares of stock, respectively, that represented
outstanding stock options whose exercise price were greater than the average market price of the
common shares during the period and were anti-dilutive. The diluted net income per common share
computation for the three months ended March 31, 2009, also excludes 5,822,551 and 4,685 shares of
common stock, issuable upon conversion of the Old Notes and New Notes, respectively, as the effect
of applying the if-converted method in calculating diluted net income per common share would be
anti-dilutive. For the three months ended March 31, 2009, the calculation of diluted earnings per
share under the two-class method is also anti-dilutive.
|
|
|
15. |
|
COMMITMENTS AND CONTINGENCIES |
Lease Exit Costs
In connection with occupancy of the new headquarter office, the Company ceased use of the
prior headquarter office in July 2008, which consists of approximately 75,000 square feet of office
space, at an average annual expense of approximately $2.1 million, under an amended lease agreement
that expires in December 2010. Under ASC 420, Exit or Disposal Cost Obligations, a liability for
the costs associated with an exit or disposal activity is recognized when the liability is
incurred. The Company recorded lease exit costs of approximately $4.8 million during the three
months ended September 30, 2008, consisting of the initial liability of $4.7 million and accretion
expense of $0.1 million. These amounts were recorded as selling, general and administrative
expenses. The Company has not recorded any other costs related to the lease for the prior
headquarters, other than accretion expense.
As of March 31, 2010, approximately $1.6 million of lease exit costs remain accrued and are
expected to be paid by December 2010, all of which is classified in other current liabilities.
Although the facilities are no longer in use by the Company, the lease exit cost accrual has not
been offset by an adjustment for estimated sublease rentals. After considering sublease market
information as well as factors specific to the lease, the Company concluded it was probable it
would be unable to obtain sublease rentals for the prior headquarters, and, therefore, it would not
be subleased for the remaining lease term. The Company will continue to monitor the sublease
market conditions and reassess the impact on the lease exit cost accrual.
The following is a summary of the activity in the liability for lease exit costs for the three
months ended March 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2009 |
|
to Expense |
|
Made |
|
from Sublease |
|
Mar. 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
Lease exit costs
liability |
|
$2,063,677 |
|
$30,950 |
|
$(534,528) |
|
$ |
|
$1,560,099 |
Legal Matters
On January 13, 2009, the Company filed suit against Mylan, Inc., Matrix Laboratories Ltd.,
(collectively Mylan), Matrix Laboratories Inc., Sandoz, Inc., (Sandoz) and Barr Laboratories,
Inc. (Barr) (collectively Defendants) in the United States District Court for the District of
Delaware seeking an adjudication that Defendants have infringed one or more claims of the Companys
838 patent by submitting to the FDA their respective ANDAs for generic versions of
SOLODYN® in its forms of 45mg, 90mg, and 135mg strengths. The relief requested by the
Company includes a request for a permanent injunction preventing Defendants from infringing the
838 patent by selling generic versions of SOLODYN®. On March 18, 2009, the Company
entered into a settlement agreement with Barr, a subsidiary of Teva Pharmaceutical Industries Ltd.
(Teva), whereby all
19
legal disputes between the Company and Teva relating to SOLODYN® were terminated
and whereby Barr/Teva agreed that Medicis patent-in-suit is valid, enforceable and not infringed
and that it should be permanently enjoined from infringement. The Delaware court subsequently
entered a permanent injunction against any infringement by Barr/Teva. On March 30, 2009, the
Delaware Court dismissed the claims between the Company and Matrix Laboratories Inc. without
prejudice, pursuant to a stipulation between Medicis and Matrix Laboratories Inc. On August 18,
2009, the Company entered into a Settlement Agreement with Sandoz whereby all legal disputes
between the Company and Sandoz relating to SOLODYN® were terminated and where Sandoz
agreed that Medicis patent-in-suit is valid, enforceable and not infringed and that it should be
permanently enjoined from infringement. The Delaware court subsequently entered a permanent
injunction against any infringement by Sandoz.
On May 6, 2009, the Company received a Paragraph IV Patent Certification from Ranbaxy
Laboratories Limited (Ranbaxy Limited) advising that Ranbaxy Limited had filed an ANDA with the
FDA for generic SOLODYN® in its form of 135mg strength. Ranbaxy Limited did not advise
the Company as to the timing or status of the FDAs review of its filing, or whether it had
complied with FDA requirements for proving bioequivalence. Ranbaxy Limiteds Paragraph IV
Certification alleged that Ranbaxy Limiteds manufacture, use, sale or offer for sale of the
product for which the ANDA was submitted would not infringe any valid claim of our 838 Patent.
The expiration date for the 838 Patent is in 2018. On June 11, 2009, the Company filed suit
against Ranbaxy Limited and Ranbaxy Inc. (collectively, Ranbaxy) in the United States District
Court for the District of Delaware seeking an adjudication that Ranbaxy has infringed one or more
claims of the 838 Patent by submitting the above ANDA to the FDA. The relief the Company
requested included a request for a permanent injunction preventing Ranbaxy from infringing the 838
Patent by selling a generic version of SOLODYN®.
On September 24, 2009, the Delaware District Court held a scheduling hearing and ordered that
the Mylan and Ranbaxy cases be consolidated and that in both cases trial will commence in May 2010.
The parties filed opening claim construction briefs on December 15, 2009, and answering claim
construction briefs on January 8, 2010. On March 25, 2010, the Delaware District Court cancelled
the April 8, 2010 Pretrial Conference and the May 7, 2010 Trial, and referred the case to
Magistrate Judge Stark to hear and address the scheduling of trial and related matters.
On January 5, 2010, the Company received a Paragraph IV Patent Certification from Ranbaxy
advising that Ranbaxy had filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-118 (Ranbaxy ANDA Supplement/Amendment I) with the FDA for generic SOLODYN® in its
forms of 45mg and 90mg strengths. Ranbaxy did not advise the Company as to the timing or status of
the FDAs review of its filing, or whether Ranbaxy had complied with FDA requirements for proving
bioequivalence. Ranbaxys Paragraph IV Certification alleged that the Companys 838 Patent is
invalid, unenforceable, and/or will not be infringed by Ranbaxys manufacture, importation, use,
sale and/or offer for sale of the products for which the Ranbaxy ANDA Supplement/Amendment I was
submitted. Ranbaxys Paragraph IV Certification also alleged that the Companys U.S. Patent No.
7,541,347 (the 347 Patent) or 7,544,373 (the 373 Patent) is not infringed by Ranbaxys
manufacture, importation, use, sale and/or offer for sale of the products for which the ANDA
Supplement/Amendment I was submitted. The expiration dates for the 347 and 373 Patents are in
2027. Ranbaxys submission as to the 45mg and 90mg strengths amended an ANDA already subject to a
30-month stay. As such, the Company believes that the Ranbaxy ANDA Supplement/Amendment I could
not be approved by the FDA until after the expiration of the 30-month period or in the event of a
court decision holding that the patents are invalid or not infringed. On February 16, 2010, the
Company filed suit against Ranbaxy in the United States District Court for the District of Delaware
seeking an adjudication that Ranbaxy infringed one or more claims of the patents by submitting the
Ranbaxy ANDA Supplement/Amendment I for generic SOLODYN® in its forms of 45mg and 90mg
strengths. The relief requested by the Company included a request for a permanent injunction
preventing Ranbaxy from infringing the 838 patent by selling generic versions of
SOLODYN®.
On April 15, 2010, the Company received a Paragraph IV Patent Certification from Ranbaxy
advising that Ranbaxy had filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-118 (Ranbaxy ANDA Supplement/Amendment II) with the FDA for generic SOLODYN® in
its forms of 65mg and 115mg strengths. Ranbaxy did not advise the Company as to the timing or
status of the FDAs review of its filing, or whether Ranbaxy had complied with FDA requirements for
proving bioequivalence. Ranbaxys Paragraph IV Certification alleged that the Companys 838
Patent is invalid, unenforceable, and/or will not be infringed by Ranbaxys manufacture,
importation, use, sale and/or offer for sale of the products for which the Ranbaxy ANDA
Supplement/Amendment II was submitted. Ranbaxys submission as to the 65mg and 115mg strengths
amended an ANDA already subject to a 30-month stay. As such, the Company believes that the
supplement or amendment could
20
not be approved by the FDA until after the expiration of the 30-month period or in the event
of a court decision holding that the patent is invalid or not infringed.
On May 4, 2010, the Company entered into a License and Settlement Agreement (the Ranbaxy
Settlement Agreement) with Ranbaxy. Pursuant to the Settlement Agreement, the Company and Ranbaxy
agreed to terminate all legal disputes between them relating to SOLODYN®. In addition,
Ranbaxy confirmed that the Companys patents relating to SOLODYN® are valid and
enforceable, and cover Ranbaxys activities relating to Ranbaxys generic SOLODYN®
products under ANDA #91-118. Ranbaxy also agreed to be permanently enjoined from any distribution
of generic SOLODYN® except pursuant to the terms of the Ranbaxy Settlement Agreement.
Under the Ranbaxy Settlement Agreement, the Company granted to Ranbaxy a license to make and sell
its generic version of SOLODYN® 45mg, 90mg and 135mg under the SOLODYN®
intellectual property rights belonging to the Company commencing in November 2011, or earlier under
certain conditions. The Company also granted to Ranbaxy a license to make and sell generic
versions of SOLODYN® 65mg and 115mg under the Companys SOLODYN® intellectual
property rights upon certain conditions but not upon any specified date in the future. The Ranbaxy
Settlement Agreement provides that Ranbaxy will be required to pay the Company royalties based on
sales of Ranbaxys generic SOLODYN® products pursuant to the foregoing licenses. In
addition, the Ranbaxy Settlement Agreement provides for the Companys grant to Ranbaxy of a license
to make and sell a branded proprietary dermatology product currently under development by Ranbaxy,
which is not therapeutically equivalent to any of the Companys currently marketed dermatology
products, under certain intellectual property rights belonging to the Company, commencing the later
of August 2011 or upon the sale of such product by Ranbaxy following approval by the FDA. Ranbaxy
will be required to pay the Company a royalty based on sales of such product pursuant to the
license.
On October 8, 2009, the Company received a Paragraph IV Patent Certification from Lupin
advising that Lupin had filed an ANDA with the FDA for generic SOLODYN® in its forms of
45mg, 90mg, and 135mg strengths. Lupin did not advise the Company as to the timing or status of
the FDAs review of its filing, or whether it has complied with FDA requirements for proving
bioequivalence. Lupins Paragraph IV Certification alleges that the Companys 838 Patent is
invalid. Lupins Paragraph IV Certification also alleges that the Companys 347 Patent or 373
Patent is not infringed by Lupins manufacture, importation, use, sale and/or offer for sale of the
products for which the Lupin ANDA was submitted. On November 17, 2009, the Company filed suit
against Lupin in the United States District Court for the District of Maryland seeking an
adjudication that Lupin has infringed one or more claims of the 838 Patent by submitting to the
FDA an ANDA for generic SOLODYN® in its forms of 45mg, 90mg and 135mg strengths. The
relief the Company requested includes a request for a permanent injunction preventing Lupin from
infringing the 838 Patent by selling generic versions of SOLODYN®. On November 24,
2009, the Company received a Paragraph IV Patent Certification from Lupin, advising that Lupin has
filed a supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 (Lupin ANDA
Supplement/Amendment I) with the FDA for generic SOLODYN ® in its form of 65mg
strength. Lupin has not advised the Company as to the timing or status of the FDAs review of its
filing, or whether Lupin has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleges that the Companys 838 Patent is invalid. Lupins Paragraph IV
Certification also alleges that the Companys 347 Patent or 373 Patent is not infringed by
Lupins manufacture, importation, use, sale and/or offer for sale of the products for which the
Lupin ANDA Supplement/Amendment I was submitted. Lupins submission amends an ANDA already subject
to a 30-month stay. As such, the Company believes that the amendment cannot be approved by the
FDA until after the expiration of the 30-month period or a court decision that the patent is
invalid or not infringed.
On December 23, 2009, the Company received a Paragraph IV Patent Certification from Lupin,
advising that Lupin has filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-424 (Lupin ANDA Supplement/Amendment II) with the FDA for generic SOLODYN ® in its
form of 115mg strength. Lupin has not advised the Company as to the timing or status of the FDAs
review of its filing, or whether Lupin has complied with FDA requirements for proving
bioequivalence. Lupins Paragraph IV Certification alleges that the Companys 838 Patent is
invalid. Lupins Paragraph IV Certification also alleges that the Companys 347 Patent or 373
Patent is not infringed by Lupins manufacture, importation, use, sale and/or offer for sale of the
products for which the Lupin ANDA Supplement/Amendment II was submitted. Lupins submission amends
an ANDA already subject to a 30-month stay. As such, the Company believes that the amendment
cannot be approved by the FDA until after the expiration of the 30-month period or a court decision
that the patent is invalid or not infringed. On December 28, 2009, the Company amended its
complaint against Lupin in the United States District Court for the District of Maryland seeking an
adjudication that Lupin has infringed one or more claims of the 838 Patent by submitting its
supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 for generic SOLODYN®
in its form
21
of 65mg strength. On February 2, 2010, the Company amended its complaint against Lupin in the
United States District Court for the District of Maryland seeking an adjudication that Lupin has
infringed one or more claims of the 838 Patent by submitting its supplement or amendment to its
earlier filed ANDA assigned ANDA #91-424 for generic SOLODYN® in its form of 115mg
strength.
On November 20, 2009, the Company received a Paragraph IV Patent Certification from Barr,
advising that Barr has filed a supplement to its earlier filed ANDA #65-485 (Barr ANDA
Supplement) with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths.
Barr has not advised the Company as to the timing or status of the FDAs review of its filing, or
whether Barr has complied with FDA requirements for proving bioequivalence. Barrs Paragraph IV
Certification alleges that the Companys 838 Patent is invalid, unenforceable and/or will not be
infringed by Barrs manufacture, use, sale and/or importation of the products for which the Barr
ANDA Supplement was submitted. On December 28, 2009, the Company filed suit against Barr and Teva
Pharmaceuticals USA, Inc., (collectively Barr/Teva USA) in the United States District Court for
the District of Maryland seeking an adjudication that Barr/Teva USA has infringed one or more
claims of the 838 Patent by submitting to the FDA the Barr ANDA Supplement for generic
SOLODYN® in its forms of 65mg and 115mg strengths. The relief the Company
requested includes a request for a permanent injunction preventing Barr/Teva USA from infringing
the 838 Patent by selling generic versions of SOLODYN® in its forms of 65mg
and 115mg strengths. As a result of the filing of the suit, the Company believes that the
supplement to the ANDA cannot be approved by the FDA until after the expiration of a 30-month stay
period or a court decision that the patent is invalid or not infringed.
On January 28, 2010, the Company received a Paragraph IV Patent Certification from Sandoz,
advising that Sandoz has filed a supplement to its earlier filed ANDA #91-422 (Sandoz ANDA
Supplement) with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths.
Sandoz has not advised the Company as to the timing or status of the FDAs review of its filing,
or whether Sandoz has complied with FDA requirements for proving bioequivalence. Sandozs
Paragraph IV Certification alleges that the Companys 838 Patent is will not be infringed by
Sandozs manufacture, use, sale and/or importation of the products for which the Sandoz ANDA
Supplement was submitted because it has been granted a patent license by the Company for the 838
Patent.
A third party requested that the U.S. Patent and Trademark Office (USPTO) conduct an Ex
Parte Reexamination of the 838 patent. The USPTO granted this request. In March 2009, the USPTO
issued a non-final office action in the reexamination of the 838 patent. On May 13, 2009, Medicis
filed its response to the non-final office action with the USPTO, canceling certain claims and
adding amended claims. On November 10, 2009, the USPTO issued a second non-final office action in
the reexamination of the 838 patent. On January 8, 2010, the Company filed its response to the
non-final office action with the USPTO. On March 17, 2010, the Company received a Notice of Intent
to Issue a Reexamination Certificate (NIRC) issued by the USPTO in connection with the USPTOs
reexamination of the 838 Patent. The NIRC states that the USPTO has closed the reexamination
proceedings and intends to issue a Reexamination Certificate as to patentable claims 3, 4, 12, and
13 (which claims are the subject of previously reported patent infringement law suits filed by the
Company in Delaware and Maryland) as well as new claims 19-34. The USPTO determined that the
claims are patentable over all the cited prior art, and has withdrawn its previous rejections of
the claims.
On March 17, 2010, the Company received a Paragraph IV Patent Certification from Taro
Pharmaceuticals U.S.A., Inc. (Taro U.S.A.) advising that Taro U.S.A. has filed an ANDA with the
FDA for a generic version of VANOS® (fluocinonide) Cream 0.1%. Taro U.S.A. has not
advised the Company as to the timing or status of the FDAs review of its filing, or whether Taro
U.S.A. has complied with FDA requirements for proving bioequivalence. Taro U.S.A.s Paragraph IV
Certification alleges that the Companys U.S. Patent No. 6,765,001 (the 001 Patent) and U.S.
Patent No. 7,220,424 (the 424 Patent) will not be infringed by Taro U.S.A.s manufacture, use
and/or sale of the product for which the ANDA was submitted, and that claim 3 of the 424 Patent is
invalid. On April 28, 2010, the Company filed suit against Taro U.S.A. and Taro Pharmaceuticals
Industries, Ltd. (collectively, Taro) in the United States District Court for the District of
Delaware and the United States District Court for the Southern District of New York seeking an
adjudication that Taro has infringed one or more claims of the 001 Patent, the 424 Patent and the
Companys U.S. Patent No. 7,217,422 by submitting the ANDA to the FDA. The relief requested by the
Company includes a request for a permanent injunction preventing Taro from infringing the patents
by selling a generic version of VANOS® prior to the expiration of the asserted patents.
On April 7, 2010, the Company received a Paragraph IV Patent Certification from Nycomed US
Inc. (Nycomed) advising that Nycomed has filed an ANDA with the FDA for a generic version of
VANOS®
22
(fluocinonide) Cream 0.1%. Nycomed has not advised the Company as to the timing or status of
the FDAs review of its filing, or whether Nycomed has complied with FDA requirements for proving
bioequivalence. Nycomeds Paragraph IV Certification alleges that the Companys U.S. Patent No.
6,765,001 (the 001 Patent) and U.S. Patent No. 7,220,424 (the 424 Patent) will not be
infringed by Nycomeds manufacture, use, sale, offer for sale or importation of the product for
which the ANDA was submitted. The expiration date for the 001 Patent is in 2021, and the
expiration date for the 424 Patent is in 2023. The Company is evaluating the details of Nycomeds
certification letter and considering its options.
On January 21, 2009, the Company received a letter from an alleged stockholder demanding
that its Board of Directors take certain actions, including potentially legal action, in connection
with the restatement of its consolidated financial statements in 2008. The letter states that, if
the Board of Directors does not take the demanded action, the alleged stockholder will commence a
derivative action on behalf of the Company. The Companys Board of Directors reviewed the letter
during the course of 2009 and established a special committee of the Board, comprised of directors
who are independent and disinterested with respect to the allegations in the letter, (i) to assess
whether there is any merit to the allegations contained in the letter, (ii) if the special
committee were to conclude that there may be merit to any of the allegations contained in the
letter, to further assess whether it is in the best interest of the Company and its shareholders to
pursue litigation or other action against any or all of the persons named in the letter or any
other persons not named in the letter, and (iii) to recommend to the Board of Directors any other
appropriate action to be taken. The special committee engaged outside counsel to assist with the
investigation. The special committee completed its investigation, and on or about February 16,
2010, the Board, pursuant to the report and recommendation of the special committee, resolved to
decline the derivative demand. Accordingly, on February 26, 2010, Company counsel sent a
declination letter to opposing counsel.
On October 3, 10, and 27, 2008, purported stockholder class action lawsuits styled Andrew Hall
v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01821-MHB); Steamfitters Local 449
Pension Fund v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01870-DKD); and Darlene
Oliver v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01964-JAT) were filed in the
United States District Court for the District of Arizona on behalf of stockholders who purchased
securities of the Company during the period between October 30, 2003 and approximately September
24, 2008. The Court consolidated these actions into a single proceeding and on May 18, 2009 an
amended complaint was filed alleging violations of the federal securities laws arising out of the
Companys restatement of its consolidated financial statements in 2008. On December 2, 2009, the
court dismissed the consolidated amended complaint without prejudice, and on January 18, 2010 the
lead plaintiff filed a second amended complaint. On February 19, 2010, the Company and the other
defendants filed motions to dismiss the second amended complaint in its entirety on various
grounds. The Company will continue to vigorously defend the claims in these consolidated matters.
There can be no assurance, however, that the Company will be successful, and an adverse resolution
of the lawsuits could have a material adverse effect on the Companys financial position and
results of operations in the period in which the lawsuits are resolved. The Company is not
presently able to reasonably estimate potential losses, if any, related to the lawsuits.
In addition to the matters discussed above, in the ordinary course of business, the Company is
involved in a number of legal actions, both as plaintiff and defendant, and could incur uninsured
liability in any one or more of them. Although the outcome of these actions is not presently
determinable, it is the opinion of the Companys management, based upon the information available
at this time, that the expected outcome of these matters, individually or in the aggregate, will
not have a material adverse effect on the results of operations, financial condition or cash flows
of the Company.
|
|
|
16. |
|
RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS |
In June 2009, the FASB issued Accounting Standards Update (ASU) No. 2009-17, Improvements to
Financial Reporting by Enterprises Involved with Variable Interest Entities, which revises guidance
on the accounting for variable interest entities. The revised guidance addresses the elimination
of the concept of a qualifying special purpose entity and replaces the quantitative-based risks and
rewards calculation for determining which enterprise has a controlling financial interest in a
variable interest entity with an approach focused on identifying which enterprise has the power to
direct the activities of the variable interest entity, and the obligation to absorb losses of the
entity or the right to receive benefits from the entity. Additionally, the revised guidance
requires any enterprise that holds a variable interest in a variable interest entity to provide
enhanced disclosures that will provide users of financial statements with more transparent
information about an enterprises involvement in a
23
variable interest entity. The revised guidance is effective for annual reporting periods
beginning after November 30, 2009. The Company adopted the new guidance on January 1, 2010, and it
did not have a material impact on its results of operations and financial condition.
In October 2009, the FASB approved for issuance ASU No. 2009-13, Revenue Recognition (ASC 605)
Multiple Deliverable Revenue Arrangements, a consensus of EITF 08-01, Revenue Arrangements
with Multiple Deliverables. This guidance modifies the fair value requirements of ASC subtopic
605-25 Revenue Recognition Multiple Element Arrangements by providing principles for allocation
of consideration among its multiple-elements, allowing more flexibility in identifying and
accounting for separate deliverables under an arrangement. An estimated selling price method is
introduced for valuing the elements of a bundled arrangement if vendor-specific objective evidence
or third-party evidence of selling price is not available, and significantly expands related
disclosure requirements. This updated guidance is effective on a prospective basis for revenue
arrangements entered into or materially modified in fiscal years beginning on or after June 15,
2010. Alternatively, adoption may be on a retrospective basis, and early application is permitted.
The Company is currently assessing what impact, if any, the updated guidance will have on its
results of operations and financial condition.
In January 2010, the FASB issued ASU No. 2010-06, Improving Disclosures about Fair Value
Measurements (ASU 2010-06), to amend ASC 820, Fair Value Measurements and Disclosures, by
improving disclosure requirements in order to increase transparency in financial reporting. ASU
2010-06 requires that an entity disclose separately the amounts of significant transfers in and out
of Level 1 and 2 fair value measurements and describe the reasons for the transfers. Furthermore,
an entity should present information about purchases, sales, issuances, and settlements for Level 3
fair value measurements. ASU 2010-06 also clarifies existing disclosures for the level of
disaggregation and disclosures about input and valuation techniques. The new disclosures and
clarifications of existing disclosures are effective for interim and annual reporting periods
beginning after December 15, 2009, except for the disclosures about purchases, sales, issuances,
and settlements for the activity in Level 3 fair value measurements. Those disclosures are
effective for fiscal years beginning after December 15, 2010, and for interim periods within those
fiscal years. On January 1, 2010, the Company adopted the disclosure amendments in ASU 2010-06,
except for the amendments to Level 3 fair value measurements as described above, and has expanded
disclosures as presented in Note 4.
The Company has evaluated subsequent events through the date of issuance of its financial
statements.
24
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
Executive Summary
We are a leading independent specialty pharmaceutical company focused primarily on helping
patients attain a healthy and youthful appearance and self-image through the development and
marketing in the U.S. of products for the treatment of dermatological and aesthetic conditions. We
also market products in Canada for the treatment of dermatological and aesthetic conditions and
began commercial efforts in Europe with our acquisition of LipoSonix in July 2008. We offer a
broad range of products addressing various conditions or aesthetics improvements, including facial
wrinkles, acne, fungal infections, rosacea, hyperpigmentation, photoaging, psoriasis, seborrheic
dermatitis and cosmesis (improvement in the texture and appearance of skin).
Our current product lines are divided between the dermatological and non-dermatological
fields. The dermatological field represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological conditions. The non-dermatological field
represents products for the treatment of urea cycle disorder, non-invasive body sculpting
technology and contract revenue. Our acne and acne-related dermatological product lines include
DYNACIN®, PLEXION®, SOLODYN®, TRIAZ® and
ZIANA®. Our non-acne dermatological product lines include DYSPORTTM,
LOPROX®, PERLANE®, RESTYLANE® and VANOS®. Our
non-dermatological product lines include AMMONUL®, BUPHENYL® and the
LIPOSONIXTM system. Our non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generic agreements.
Financial Information About Segments
We operate in one business segment: pharmaceuticals. Our current pharmaceutical franchises
are divided between the dermatological and non-dermatological fields. Information on revenues,
operating income, identifiable assets and supplemental revenue of our business franchises appears
in the condensed consolidated financial statements included in Item 1 hereof.
Key Aspects of Our Business
We derive a majority of our revenue from our primary products: DYSPORTTM,
PERLANE®, RESTYLANE®, SOLODYN®, TRIAZ®,
VANOS® and ZIANA®. We believe that sales of our primary products will
constitute a significant portion of our revenue for 2010.
We have built our business by executing a four-part growth strategy: promoting existing
brands, developing new products and important product line extensions, entering into strategic
collaborations and acquiring complementary products, technologies and businesses. Our core
philosophy is to cultivate high integrity relationships of trust and confidence with the foremost
dermatologists and the leading plastic surgeons in the U.S. We rely on third parties to
manufacture our products (except for the LIPOSONIXTM system).
We estimate customer demand for our prescription products primarily through use of third party
syndicated data sources which track prescriptions written by health care providers and dispensed by
licensed pharmacies. The data represents extrapolations from information provided only by certain
pharmacies and are estimates of historical demand levels. We estimate customer demand for our
non-prescription products primarily through internal data that we compile. We observe trends from
these data and, coupled with certain proprietary information, prepare demand forecasts that are the
basis for purchase orders for finished and component inventory from our third party manufacturers
and suppliers. Our forecasts may fail to accurately anticipate ultimate customer demand for our
products. Overestimates of demand and sudden changes in market conditions may result in excessive
inventory production and underestimates may result in inadequate supply of our products in channels
of distribution.
We schedule our inventory purchases to meet anticipated customer demand. As a result,
miscalculation of customer demand or relatively small delays in our receipt of manufactured
products could result in revenues being deferred or lost. Our operating expenses are based upon
anticipated sales levels, and a high percentage of our operating expenses are relatively fixed in
the short term.
We sell our products primarily to major wholesalers and retail pharmacy chains. Approximately
65-75% of our gross revenues are typically derived from two major drug wholesale concerns.
Depending on the customer, we
25
recognize revenue at the time of shipment to the customer, or at the time of receipt by the
customer, net of estimated provisions. As a result of certain amendments made to our distribution
services agreement with McKesson, our exclusive U.S. distributor of our aesthetics products
DYSPORTTM, PERLANE® and RESTYLANE®, we began recognizing revenue
on these products upon the shipment from McKesson to physicians beginning in the second quarter of
2009. Consequently, variations in the timing of revenue recognition could cause significant
fluctuations in operating results from period to period and may result in unanticipated periodic
earnings shortfalls or losses. We have distribution services agreements with our two largest
wholesale customers. We review the supply levels of our significant products sold to major
wholesalers by reviewing periodic inventory reports that are supplied to us by our major
wholesalers in accordance with the distribution services agreements. We rely wholly upon our
wholesale and drug chain customers to effect the distribution allocation of substantially all of
our prescription products. We believe our estimates of trade inventory levels of our products,
based on our review of the periodic inventory reports supplied by our major wholesalers and the
estimated demand for our products based on prescription and other data, are reasonable. We further
believe that inventories of our products among wholesale customers, taken as a whole, are similar
to those of other specialty pharmaceutical companies, and that our trade practices, which
periodically involve volume discounts and early payment discounts, are typical of the industry.
We periodically offer promotions to wholesale and chain drugstore customers to encourage
dispensing of our prescription products, consistent with prescriptions written by licensed health
care providers. Because many of our prescription products compete in multi-source markets, it is
important for us to ensure the licensed health care providers dispensing instructions are
fulfilled with our branded products and are not substituted with a generic product or another
therapeutic alternative product which may be contrary to the licensed health care providers
recommended and prescribed Medicis brand. We believe that a critical component of our brand
protection program is maintenance of full product availability at drugstore and wholesale
customers. We believe such availability reduces the probability of local and regional product
substitutions, shortages and backorders, which could result in lost sales. We expect to continue
providing favorable terms to wholesale and retail drug chain customers as may be necessary to
ensure the fullest possible distribution of our branded products within the pharmaceutical chain of
commerce. From time to time we may enter into business arrangements (e.g., loans or investments)
involving our customers and those arrangements may be reviewed by federal and state regulators.
Purchases by any given customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same period, resulting in fluctuations of
product inventory in the distribution channel.
Recent Developments
As described in more detail below, the following significant events and transactions occurred
during the three months ended March 31, 2010, and affected our results of operations, our cash
flows and our financial condition:
- |
|
FDA approval of RESTYLANE-LTM and PERLANE-LTM; and |
|
- |
|
Increase of our quarterly dividend from $0.04 per share to $0.06 per share. |
FDA approval of RESTYLANE-LTM and PERLANE-LTM
On January 29, 2010, the FDA approved our dermal fillers RESTYLANE-LTM and
PERLANE-LTM, which include the addition of 0.3% lidocaine. RESTYLANE-LTM is
approved for implantation into the mid to deep dermis, and PERLANE-LTM is approved for
implantation into the deep dermis to superficial subcutis, both for the correction of moderate to
severe facial wrinkles and folds, such as nasolabial folds. We began shipping
RESTYLANE-LTM and PERLANE-LTM during February 2010.
Increase of our quarterly dividend from $0.04 per share to $0.06 per share
On March 10, 2010, we declared a cash dividend of $0.06 per issued and outstanding share of
our Class A common stock, payable on April 30, 2010, to stockholders of record at the close of
business on April 1, 2010. This represents a 50% increase compared to our previous $0.04 dividend.
26
Results of Operations
The following table sets forth certain data as a percentage of net revenues for the periods
indicated.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
(a |
) |
|
|
(b |
) |
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (c) |
|
|
90.5 |
|
|
|
90.5 |
|
Operating expenses |
|
|
56.0 |
|
|
|
91.0 |
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
34.5 |
|
|
|
(0.5 |
) |
Other income (expense), net |
|
|
(0.2 |
) |
|
|
(2.9 |
) |
Interest and investment income,
net |
|
|
0.1 |
|
|
|
1.5 |
|
|
|
|
|
|
|
|
Income before income tax expense |
|
|
34.4 |
|
|
|
(1.9 |
) |
Income tax (expense) benefit |
|
|
(13.2 |
) |
|
|
2.2 |
|
|
|
|
|
|
|
|
Net income |
|
|
21.2 |
% |
|
|
0.3 |
% |
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $3.1 million (1.9% of net revenues) of compensation
expense related to stock options, restricted stock and stock appreciation rights. |
|
(b) |
|
Included in operating expenses is $5.0 million (5.0% of net revenues) paid to IMPAX related
to a product development agreement and $3.9 million (3.9% of net revenues) of compensation
expense related to stock options, restricted stock and stock appreciation rights. |
|
(c) |
|
Gross profit does not include amortization of the related intangibles as such expense is
included in operating expenses. |
27
Three Months Ended March 31, 2010 Compared to the Three Months Ended March 31, 2009
Net Revenues
The following table sets forth our net revenues for the three months ended March 31, 2010 (the
first quarter of 2010) and March 31, 2009 (the first quarter of 2009), along with the
percentage of net revenues and percentage point change for each of our product categories (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
164.5 |
|
|
$ |
96.6 |
|
|
$ |
67.9 |
|
|
|
70.3 |
% |
Net contract revenues |
|
|
2.0 |
|
|
|
3.2 |
|
|
|
(1.2 |
) |
|
|
(37.5) |
% |
|
|
|
Total net revenues |
|
$ |
166.5 |
|
|
$ |
99.8 |
|
|
$ |
66.7 |
|
|
|
66.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
|
Acne and acne-related
dermatological products |
|
$ |
120.2 |
|
|
$ |
66.4 |
|
|
$ |
53.8 |
|
|
|
81.0 |
% |
Non-acne dermatological
products |
|
|
34.3 |
|
|
|
23.5 |
|
|
|
10.8 |
|
|
|
46.0 |
% |
Non-dermatological products
(including contract revenues) |
|
|
12.0 |
|
|
|
9.9 |
|
|
|
2.1 |
|
|
|
21.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
166.5 |
|
|
$ |
99.8 |
|
|
$ |
66.7 |
|
|
|
66.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne and acne-related
dermatological products |
|
|
72.2 |
% |
|
|
66.6 |
% |
|
|
5.6 |
% |
Non-acne dermatological
products |
|
|
20.6 |
% |
|
|
23.5 |
% |
|
|
(2.9) |
% |
Non-dermatological products
(including contract revenues) |
|
|
7.2 |
% |
|
|
9.9 |
% |
|
|
(2.7) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
Net revenues associated with our acne and acne-related dermatological products increased by
$53.8 million, or 81.0%, during the first quarter of 2010 as compared to the first quarter of 2009
primarily as a result of increased sales of SOLODYN® and ZIANA®, both of
which generated strong prescription growth. Net revenues of SOLODYN® during the first
quarter of 2009 were negatively impacted by the unauthorized one-day launch of Tevas generic
SOLODYN® product units that were sold into the distribution channel prior to the
consummation of a Settlement Agreement with us on March 18, 2009. These units caused wholesalers
to reduce ordering levels of SOLODYN® and caused us to increase our reserves for sales
returns and consumer rebates during the first quarter of 2009. In addition, during the third
quarter of 2009 we launched new 65mg and 115mg strengths of SOLODYN® after they were
approved by the FDA.
Net revenues associated with our non-acne dermatological products increased by $10.8 million,
or 46.0% during the first quarter of 2010 as compared to the first quarter of 2009, primarily due
to sales of DYSPORTTM, which was launched in June 2009, and increased sales of
RESTYLANE®. RESTYLANE-LTM and PERLANE-LTM were launched during
February 2010 following FDA approval on January 29, 2010. Net revenues associated with our
non-acne dermatological products decreased as a percentage of net revenues during the first quarter
of 2010 as
28
compared to the first quarter of 2009, primarily due to the $53.8 million increase in our acne
and acne-related dermatological products. Beginning in the second quarter of 2009, as a result of
certain modifications made to our distribution services agreement with McKesson, our exclusive U.S.
distributor of our aesthetics products RESTYLANE®, PERLANE® and
DYSPORTTM, we began recognizing revenue on these products upon the shipment from
McKesson to physicians. As a result, aesthetic product net revenues were negatively
impacted during the first quarter of 2009 in anticipation of this change in revenue recognition.
Net revenues associated with our non-dermatological products increased by $2.1 million, or
21.2%, during the first quarter of 2010 as compared to the first quarter of 2009 primarily due to
an increase in sales of BUPHENYL®.
Total net revenues during the first quarter of 2009 were negatively impacted by a $5.5 million
increase in our rebate liabilities for certain Medicaid and Department of Defense/TRICARE rebates.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our acquisition cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to products sold is not included in gross profit. Amortization expense related to these
intangibles for the first quarter of 2010 and 2009 was approximately $5.4 million. Product mix
plays a significant role in our quarterly and annual gross profit as a percentage of net revenues.
Different products generate different gross profit margins, and the relative sales mix of higher
gross profit products and lower gross profit products can affect our total gross profit.
The following table sets forth our gross profit for the first quarter of 2010 and 2009, along
with the percentage of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
$ |
150.7 |
|
|
$ |
90.4 |
|
|
$ |
60.3 |
|
|
|
66.7 |
% |
% of net revenues |
|
|
90.5 |
% |
|
|
90.5 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the first quarter of 2010 as compared to the first quarter
of 2009 is primarily due to the $66.7 million increase in net revenues. Gross profit as a
percentage of net revenues was 90.5% during both the first quarter of 2010 and the first quarter of
2009. Net revenues of SOLODYN®, a high gross margin product, increased during the first
quarter of 2010 as compared to the first quarter of 2009, while net revenues of other products,
which have lower gross margins, also increased.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the first
quarter of 2010 and 2009, along with the percentage of net revenues represented by selling, general
and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
|
Selling, general and administrative |
|
$ |
75.9 |
|
|
$ |
70.4 |
|
|
$ |
5.5 |
|
|
|
7.8 |
% |
% of net revenues |
|
|
45.6 |
% |
|
|
70.6 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
3.0 |
|
|
$ |
3.7 |
|
|
$ |
(0.7 |
) |
|
|
(18.9) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative expenses increased $5.5 million, or 7.8%, during the first
quarter of 2010 as compared to the first quarter of 2009, but decreased as a percentage of net
revenues from 70.6% during the first quarter of 2009 to 45.6% during the first quarter of 2010.
Included in this increase was a $4.6 million increase in promotion expenses, primarily related to
the launch of DYSPORTTM and a $1.3 million increase in personnel
costs, primarily due to the effect of the annual salary increase that occurred during February
2010, partially offset by a decrease of $0.4 million of other
selling, general and administrative costs. The decrease of selling, general and
29
administrative expenses as a percentage of net
revenues during the first quarter of 2010 as compared to the first quarter of 2009 was primarily
due to the $66.7 million increase in net revenues.
Research and Development Expenses
The following table sets forth our research and development expenses for the first quarter of
2010 and 2009 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
|
Research and development |
|
$ |
10.2 |
|
|
$ |
13.3 |
|
|
$ |
(3.1 |
) |
|
|
(23.3) |
% |
Charges included in
research
and development |
|
$ |
|
|
|
$ |
5.0 |
|
|
$ |
(5.0 |
) |
|
|
(100.0) |
% |
Share-based compensation
expense included in
research and development |
|
$ |
0.1 |
|
|
$ |
0.1 |
|
|
$ |
|
|
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in research and development expenses for the first quarter of 2009 was a $5.0 million
milestone payment to Impax related to a development agreement. We expect research and development
expenses to continue to fluctuate from quarter to quarter based on the timing of the achievement of
development milestones under license and development agreements, as well as the timing of other
development projects and the funds available to support these projects.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the first quarter of 2010 and the first quarter
of 2009 were $7.1 million. An increase related to amortization of the $75.0 million milestone
payment made to Ipsen during the second quarter of 2009 upon the FDAs approval of
DYSPORTTM, which was capitalized as an intangible asset, was offset by the amortization
expense related to intangible assets related to Medicis Pediatrics, Inc., which was sold to
BioMarin Pharmaceutical Inc. during the second quarter of 2009, not being incurred during the first
quarter of 2010.
Interest and Investment Income
Interest and investment income during the first quarter of 2010 decreased $1.3 million, or
53.4%, to $1.2 million from $2.5 million during the first quarter of 2009, due to a decrease in the
interest rates achieved by our invested funds during the first quarter of 2010.
Interest Expense
Interest expense during the first quarter of 2010 and the first quarter of 2009 was $1.1
million. Our interest expense during the first quarter of 2010 and 2009 consisted of interest
expense on our Old Notes, which accrue interest at 2.5% per annum, and our New Notes, which accrue
interest at 1.5% per annum. See Note 10 in our accompanying condensed consolidated financial
statements for further discussion on the Old Notes and New Notes.
Other Expense, net
Other expense of $0.3 million recognized during the first quarter of 2010 represented an
other-than-temporary impairment on an asset-backed security investment.
Other expense, net, of $2.9 million recognized during the first quarter of 2009 primarily
represented a reduction in the carrying value of our investment in Revance as a result of a
reduction in the estimated net realizable value of the investment using the hypothetical
liquidation at book value approach as of March 31, 2009.
Income Tax Expense
Our effective tax rate for the first quarter of 2010 was 38.4%, as compared to 117.3% for the
first quarter of 2009. The effective tax rate for the first quarter of 2009 reflects a $1.4 million
discrete tax benefit recognized due to statute closures. Excluding the discrete tax benefit, the
effective tax rate for the first quarter of 2009 was 41.6%.
30
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the first quarter of 2010 and
2009, and selected balance sheet components as of March 31, 2010 and December 31, 2009 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
37.9 |
|
|
$ |
45.4 |
|
|
$ |
(7.5 |
) |
|
|
(16.5) |
% |
Investing activities |
|
|
(142.0 |
) |
|
|
9.2 |
|
|
|
(151.2 |
) |
|
|
(1,643.5) |
% |
Financing activities |
|
|
(1.3 |
) |
|
|
(2.3 |
) |
|
|
1.0 |
|
|
|
(43.5) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mar. 31, 2010 |
|
Dec. 31, 2009 |
|
$ Change |
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
558.5 |
|
|
$ |
528.3 |
|
|
$ |
30.2 |
|
|
|
5.7 |
% |
Working capital |
|
|
474.2 |
|
|
|
434.6 |
|
|
|
39.6 |
|
|
|
9.1 |
% |
Long-term investments |
|
|
30.0 |
|
|
|
25.5 |
|
|
|
4.5 |
|
|
|
17.6 |
% |
2.5% contingent convertible
senior notes due 2032 |
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
% |
1.5% contingent convertible
senior notes due 2033 |
|
|
0.2 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
% |
Working Capital
Working capital as of March 31, 2010 and December 31, 2009, consisted of the following (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mar. 31, 2010 |
|
Dec. 31, 2009 |
|
$ Change |
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
558.5 |
|
|
$ |
528.3 |
|
|
$ |
30.2 |
|
|
|
5.7 |
% |
Accounts receivable, net |
|
|
110.0 |
|
|
|
95.2 |
|
|
|
14.8 |
|
|
|
15.5 |
% |
Inventories, net |
|
|
29.4 |
|
|
|
26.0 |
|
|
|
3.4 |
|
|
|
13.1 |
% |
Deferred tax assets, net |
|
|
66.6 |
|
|
|
66.3 |
|
|
|
0.3 |
|
|
|
0.5 |
% |
Other current assets |
|
|
19.7 |
|
|
|
16.5 |
|
|
|
3.2 |
|
|
|
19.4 |
% |
|
|
|
Total current assets |
|
|
784.2 |
|
|
|
732.3 |
|
|
|
51.9 |
|
|
|
7.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
47.7 |
|
|
|
44.2 |
|
|
|
3.5 |
|
|
|
7.9 |
% |
Reserve for sales returns |
|
|
43.7 |
|
|
|
48.1 |
|
|
|
(4.4 |
) |
|
|
(9.1) |
% |
Accrued consumer rebate and
loyalty programs |
|
|
94.6 |
|
|
|
73.3 |
|
|
|
21.3 |
|
|
|
29.1 |
% |
Managed care and Medicaid
reserves |
|
|
49.0 |
|
|
|
47.1 |
|
|
|
1.9 |
|
|
|
4.0 |
% |
Income taxes payable |
|
|
15.8 |
|
|
|
16.7 |
|
|
|
(0.9 |
) |
|
|
(5.4) |
% |
Other current liabilities |
|
|
59.2 |
|
|
|
68.3 |
|
|
|
(9.1 |
) |
|
|
(13.3) |
% |
|
|
|
Total current liabilities |
|
|
310.0 |
|
|
|
297.7 |
|
|
|
12.3 |
|
|
|
4.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
474.2 |
|
|
$ |
434.6 |
|
|
$ |
39.6 |
|
|
|
9.1 |
% |
|
|
|
|
|
|
|
31
We had cash, cash equivalents and short-term investments of $558.5 million and working capital
of $474.2 million at March 31, 2010, as compared to $528.3 million and $434.6 million,
respectively, at December 31, 2009. The increases were primarily due to the generation of $37.9
million of operating cash flow during the first quarter of 2010.
Management believes existing cash and short-term investments, together with funds generated
from operations, should be sufficient to meet operating requirements for the foreseeable future.
Our cash and short-term investments are available for dividends, milestone payments related to our
product development collaborations, strategic investments, acquisitions of companies or products
complementary to our business, the repayment of outstanding indebtedness, repurchases of our
outstanding securities and other potential large-scale needs. In addition, we may consider
incurring additional indebtedness and issuing additional debt or equity securities in the future to
fund potential acquisitions or investments, to refinance existing debt or for general corporate
purposes. If a material acquisition or investment is completed, our operating results and
financial condition could change materially in future periods. However, no assurance can be given
that additional funds will be available on satisfactory terms, or at all, to fund such activities.
On July 1, 2008, we acquired LipoSonix, an independent, privately-held company with a staff of
approximately 40 scientists, engineers and clinicians located near Seattle, Washington.
LipoSonix, now known as Medicis Technologies Corporation, is a medical device company developing
non-invasive body sculpting technology. Its first product, the LIPOSONIXTM system, is
currently marketed and sold through distributors in Europe and Canada. On June 15, 2009, Medicis
Aesthetics Canada, Ltd. announced that Health Canada had issued a Medical Device License
authorizing the sale of the LIPOSONIXTM system in Canada. In the U.S., the
LIPOSONIXTM system is an investigational device and is not currently cleared or approved
for sale. Under terms of the transaction, we paid $150 million in cash for all of the outstanding
shares of LipoSonix. In addition, we will pay LipoSonix stockholders certain milestone payments up
to an additional $150 million upon FDA approval of the LIPOSONIXTM system and if various
commercial milestones are achieved on a worldwide basis.
As of March 31, 2010, our short-term investments included $26.3 million of auction rate
floating securities. Our auction rate floating securities are debt instruments with a long-term
maturity and with an interest rate that is reset in short intervals through auctions. During the
three months ended March 31, 2008, we were informed that there was insufficient demand at auction
for the auction rate floating securities, and since that time we have been unable to liquidate our
holdings in such securities. As a result, these affected auction rate floating securities are now
considered illiquid, and we could be required to hold them until they are redeemed by the holder at
maturity or until a future auction on these investments is successful. During the first quarter of
2010, we liquidated $0.6 million of our auction rate floating securities at par.
Operating Activities
Net cash provided by operating activities during the first quarter of 2010 was approximately
$37.9 million, compared to cash provided by operating activities of approximately $45.4 million
during the first quarter of 2009. The following is a summary of the primary components of cash
provided by operating activities during the first quarter of 2010 and first quarter of 2009 (in
millions):
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
2010 |
|
2009 |
|
Income taxes paid |
|
|
(16.8 |
) |
|
|
(1.5 |
) |
Payments made to IMPAX related to development agreement |
|
|
|
|
|
|
(5.0 |
) |
Other cash provided by operating activities |
|
|
54.7 |
|
|
|
51.9 |
|
|
|
|
Cash provided by operating activities |
|
$ |
37.9 |
|
|
$ |
45.4 |
|
|
|
|
Investing Activities
Net cash used in investing activities during the first quarter of 2010 was approximately
$142.0 million, compared to net cash provided by investing activities during the first quarter of
2009 of $9.2 million. The change was primarily due to the net purchases and sales of our
short-term and long-term investments during the respective quarters.
32
Financing Activities
Net cash used in financing activities during the first quarter of 2010 was $1.3 million,
compared to net cash used in financing activities of $2.3 million during the first quarter of 2009.
Proceeds from the exercise of stock options were $0.9 million during the first quarter of 2010
compared to $0 during the first quarter of 2009. Dividends paid during the first quarter of 2010
were $2.4 million, and dividends paid during the first quarter of 2009 were $2.3 million.
Contingent Convertible Senior Notes and Other Long-Term Commitments
We have two outstanding series of Contingent Convertible Senior Notes, consisting of $169.2
million principal amount of 2.5% Contingent Convertible Senior Notes due 2032 (the Old Notes) and
$0.2 million principal amount of 1.5% Contingent Convertible Senior Notes due 2033 (the New
Notes). The New Notes and the Old Notes are unsecured and do not contain any restrictions on the
incurrence of additional indebtedness or the repurchase of our securities, and do not contain any
financial covenants. The Old Notes do not contain any restrictions on the payment of dividends.
The New Notes require an adjustment to the conversion price if the cumulative aggregate of all
current and prior dividend increases above $0.025 per share would result in at least a one percent
(1%) increase in the conversion price. This threshold has not been reached and no adjustment to
the conversion price has been made. On June 4, 2012 and 2017, or upon the occurrence of a change
in control, holders of the Old Notes may require us to offer to repurchase their Old Notes for
cash. On June 4, 2013 and 2018, or upon the occurrence of a change in control, holders of the New
Notes may require us to offer to repurchase their New Notes for cash.
Except for the New Notes and Old Notes, we had only $8.9 million of long-term liabilities at
March 31, 2010, and we had $310.0 million of current liabilities at March 31, 2010. Our other
commitments and planned expenditures consist principally of payments we will make in connection
with strategic collaborations and research and development expenditures, and we will continue to
invest in sales and marketing infrastructure.
In connection with occupancy of the new headquarter office during 2008, we ceased use of the
prior headquarter office, which consists of approximately 75,000 square feet of office space, at an
average annual expense of approximately $2.1 million, under an amended lease agreement that expires
in December 2010. Under ASC 420, Exit or Disposal Cost Obligations, a liability for the costs
associated with an exit or disposal activity is recognized when the liability is incurred. We
recorded lease exit costs of approximately $4.8 million during the three months ended September 30,
2008 consisting of the initial liability of $4.7 million and accretion expense of $0.1 million. We
have not recorded any other costs related to the lease for the prior headquarters.
As of March 31, 2010, approximately $1.6 million of lease exit costs remain accrued and are
expected to be paid by December 2010, all of which is classified in other current liabilities.
Although we no longer use the facilities, the lease exit cost accrual has not been offset by an
adjustment for estimated sublease rentals. After considering sublease market information as well
as factors specific to the lease, we concluded it was probable we would be unable to reasonably
obtain sublease rentals for the prior headquarters and therefore we would not be subleased for the
remaining lease term. We will continue to monitor the sublease market conditions and reassess the
impact on the lease exit cost accrual.
The following is a summary of the activity in the liability for lease exit costs for the three
months ended March 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2009 |
|
to Expense |
|
Made |
|
from Sublease |
|
Mar. 31, 2010 |
Lease exit costs
liability |
|
$ |
2,063,677 |
|
|
$ |
30,950 |
|
|
$ |
(534,528 |
) |
|
$ |
|
|
|
$ |
1,560,099 |
|
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $49.0 million on our common stock. In addition, on March 10, 2010, we
declared a cash dividend of
33
$0.06 per issued and outstanding share of common stock payable on April 30, 2010, to our
stockholders of record at the close of business on April 1, 2010. This represents a 50% increase
compared to our previous $0.04 dividend. Prior to these dividends, we had not paid a cash dividend
on our common stock. Any future determinations to pay cash dividends will be at the discretion of
our Board of Directors and will be dependent upon our financial condition, operating results,
capital requirements and other factors that our Board of Directors deems relevant.
Fair Value Measurements
We utilize unobservable (Level 3) inputs in determining the fair value of our auction rate
floating security investments, which totaled $26.3 million at March 31, 2010. These securities
were included in long-term investments at March 31, 2010. We also utilize unobservable (Level 3)
inputs to value our investment in Hyperion Therapeutics, Inc.
Our auction rate floating securities are classified as available-for-sale securities or
trading securities and are reflected at fair value. In prior periods, due to the auction process
which took place every 30-35 days for most securities, quoted market prices were readily available,
which would qualify as Level 1 under ASC 820, Fair Value Measurements and Disclosure. However, due
to events in credit markets that began during the first quarter of 2008, the auction events for
most of these instruments failed, and, therefore, we determined the estimated fair values of these
securities, beginning in the first quarter of 2008, utilizing a discounted cash flow
analysis. These analyses consider, among other items, the collateralization underlying the
security investments, the expected future cash flows, including the final maturity, associated with
the securities, and the expectation of the next time the security is expected to have a successful
auction. These securities were also compared, when possible, to other observable market data with
similar characteristics to the securities held by us. Due to these events, we reclassified these
instruments as Level 3 during the first quarter of 2008.
In November 2008, we entered into a settlement agreement with the broker through which we
purchased auction rate floating securities. The settlement agreement provides us with the right to
put an auction rate floating security currently held by us back to the broker beginning on June 30,
2010. At March 31, 2010 and December 31, 2009, we held one auction rate floating security with a
par value of $1.3 million that was subject to the settlement agreement. We elected the irrevocable
Fair Value Option treatment under ASC 825, Financial Instruments, and adjusted the put option to
fair value. We reclassified this auction rate floating security from available-for-sale to trading
securities as of December 31, 2008, and future changes in fair value related to this investment and
the related put right will be recorded in earnings.
Off-Balance Sheet Arrangements
As of March 31, 2010, we are not involved in any off-balance sheet arrangements, as defined in
Item 3(a)(4)(ii) of Securities and Exchange Commission (SEC) Regulation S-K.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based
upon our condensed consolidated financial statements, which have been prepared in conformity with
U.S. generally accepted accounting principles. The preparation of the condensed consolidated
financial statements requires us to make estimates and assumptions that affect the amounts reported
in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, we
evaluate our estimates related to sales allowances, chargebacks, rebates, returns and other pricing
adjustments, depreciation and amortization and other contingencies and litigation. We base our
estimates on historical experience and various other factors related to each circumstance. Actual
results could differ from those estimates based upon future events, which could include, among
other risks, changes in the regulations governing the manner in which we sell our products, changes
in the health care environment and managed care consumption patterns. Our significant accounting
policies are described in Note 2 to the consolidated financial statements included in our Form 10-K
for the year ended December 31, 2009. There were no new significant accounting estimates in the
first quarter of 2010, nor were there any material changes to the critical accounting policies and
estimates discussed in our Form 10-K for the year ended December 31, 2009.
34
Recent Accounting Pronouncements
In June 2009, the FASB issued Accounting Standards Update (ASU) No. 2009-17, Improvements to
Financial Reporting by Enterprises Involved with Variable Interest Entities, which revises guidance
on the accounting for variable interest entities. The revised guidance addresses the elimination
of the concept of a qualifying special purpose entity and replaces the quantitative-based risks and
rewards calculation for determining which enterprise has a controlling financial interest in a
variable interest entity with an approach focused on identifying which enterprise has the power to
direct the activities of the variable interest entity, and the obligation to absorb losses of the
entity or the right to receive benefits from the entity. Additionally, the revised guidance
requires any enterprise that holds a variable interest in a variable interest entity to provide
enhanced disclosures that will provide users of financial statements with more transparent
information about an enterprises involvement in a variable interest entity. The revised guidance
is effective for annual reporting periods beginning after November 30, 2009. We adopted the new
guidance on January 1, 2010, and it did not have a material impact on our results of operations and
financial condition.
In October 2009, the FASB approved for issuance ASU No. 2009-13, Revenue Recognition (ASC 605)
Multiple Deliverable Revenue Arrangements, a consensus of EITF 08-01, Revenue Arrangements with
Multiple Deliverables. This guidance modifies the fair value requirements of ASC subtopic 605-25
Revenue Recognition Multiple Element Arrangements by providing principles for allocation of
consideration among its multiple-elements, allowing more flexibility in identifying and accounting
for separate deliverables under an arrangement. An estimated selling price method is introduced
for valuing the elements of a bundled arrangement if vendor-specific objective evidence or
third-party evidence of selling price is not available, and significantly expands related
disclosure requirements. This updated guidance is effective on a prospective basis for revenue
arrangements entered into or materially modified in fiscal years beginning on or after June 15,
2010. Alternatively, adoption may be on a retrospective basis, and early application is permitted.
We are currently assessing what impact, if any, the updated guidance will have on our results of
operations and financial condition.
In January 2010, the FASB issued ASU No. 2010-06, Improving Disclosures about Fair Value
Measurements (ASU 2010-06), to amend ASC 820, Fair Value Measurements and Disclosures, by
improving disclosure requirements in order to increase transparency in financial reporting. ASU
2010-06 requires that an entity disclose separately the amounts of significant transfers in and out
of Level 1 and 2 fair value measurements and describe the reasons for the transfers. Furthermore,
an entity should present information about purchases, sales, issuances, and settlements for Level 3
fair value measurements. ASU 2010-06 also clarifies existing disclosures for the level of
disaggregation and disclosures about input and valuation techniques. The new disclosures and
clarifications of existing disclosures are effective for interim and annual reporting periods
beginning after December 15, 2009, except for the disclosures about purchases, sales, issuances,
and settlements for the activity in Level 3 fair value measurements. Those disclosures are
effective for fiscal years beginning after December 15, 2010, and for interim periods within those
fiscal years. On January 1, 2010, we adopted the disclosure amendments in ASU 2010-06, except for
the amendments to Level 3 fair value measurements as described above, and have expanded disclosures
as presented in Note 4 of our condensed consolidated financial statements.
Forward Looking Statements
This Quarterly Report on Form 10-Q and other documents we file with the SEC include
forward-looking statements. These include statements relating to future actions, prospective
products or product approvals, future performance or results of current and anticipated products,
sales and marketing efforts, expenses, the outcome of contingencies, such as legal proceedings, and
financial results. From time to time, we also may make forward-looking statements in press
releases or written statements, or in our communications and discussions with investors and
analysts in the normal course of business through meetings, webcasts, phone calls and conference
calls. All statements other than statements of historical fact are, or may be deemed to be,
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act).
These statements are based on certain assumptions made by us based on our experience and perception
of historical trends, current conditions, expected future developments and other factors we believe
are appropriate in the circumstances. We caution you that actual outcomes and results may differ
materially from what is expressed, implied or forecast by our forward-looking statements. Such
statements are subject to a number of assumptions, risks and uncertainties, many of which are
beyond our control. You can identify these statements by the fact that they do not relate strictly
to historical or current facts. They use words such
35
as anticipate, estimate, expect, project, intend, plan, believe, will, should,
outlook, could, target, and other words and terms of similar meaning in connection with any
discussion of future operations or financial performance. Among the factors that could cause
actual results to differ materially from our forward-looking statements are the following:
|
|
competitive developments affecting our products, such as the FDA approvals of
Prevelle® Silk, Radiesse®, Sculptra®, Artefill®,
Hydrelle, Juvéderm® Ultra and Juvéderm® Ultra Plus,
competitors to RESTYLANE® and PERLANE®, a generic form of our
DYNACIN® Tablets product, generic forms of our LOPROX® TS,
LOPROX® Cream, LOPROX® Gel and LOPROX® Shampoo products, and
potential generic forms of our TRIAZ®, PLEXION®, SOLODYN® or
VANOS® products; |
|
|
increases or decreases in the expected costs to be incurred in connection with the research
and development, clinical trials, regulatory approvals, commercialization and marketing of our
products; |
|
|
the success of research and development activities, including the development of additional
forms of SOLODYN®, and our ability to obtain regulatory approvals; |
|
|
the speed with which regulatory authorizations and product launches may be achieved; |
|
|
changes in the FDAs position on the safety or effectiveness of our products; |
|
|
changes in our product mix; |
|
|
the anticipated size of the markets and demand for our products; |
|
|
changes in prescription levels; |
|
|
the impact of acquisitions, divestitures and other significant corporate transactions,
including our acquisition of LipoSonix; |
|
|
risks associated with realizing all of the anticipated benefits of our acquisition of
LipoSonix; |
|
|
the effect of economic changes generally and in hurricane-effected areas; |
|
|
manufacturing or supply interruptions; |
|
|
importation of other dermal filler or botulinum toxin products, including the unauthorized
distribution of products approved in countries neighboring the U.S.; |
|
|
changes in the prescribing or procedural practices of dermatologists, podiatrists and/or
plastic surgeons, including prescription levels; |
|
|
the ability to successfully market both new products, including DYSPORTTM, and
existing products; |
|
|
difficulties or delays in manufacturing and packaging of our products, including
delays and quality control lapses of third party manufacturers and suppliers of our
products; |
|
|
the availability of product supply or changes in the cost of raw materials; |
|
|
the ability to compete against generic and other branded products; |
|
|
trends toward managed care and health care cost containment; |
|
|
inadequate protection of our intellectual property or challenges to the validity or
enforceability of our proprietary rights and our ability to secure patent protection from
filed patent applications for our primary products, including SOLODYN®; |
|
|
possible introduction of generic versions of our products, including SOLODYN®; |
|
|
possible federal and/or state legislation or regulatory action affecting, among other
things, the Companys ability to enter into agreements with companies introducing generic
versions of the Companys products as well as pharmaceutical pricing and reimbursement,
including Medicaid and Medicare and involuntary approval of prescription medicines for
over-the-counter use; |
|
|
legal defense costs, insurance expenses, settlement costs and the risk of an adverse
decision or settlement related to product liability, patent protection, government
investigations, and other legal proceedings (see Part II, Item 1, Legal Proceedings); |
|
|
changes in U.S. generally accepted accounting principles; |
|
|
additional costs related to compliance with changing regulation of corporate
governance and public financial disclosure; |
|
|
any changes in business, political and economic conditions due to the threat of future
terrorist activity in the U.S. and other parts of the world; |
|
|
access to available and feasible financing on a timely basis; |
|
|
the availability of product acquisition or in-licensing opportunities; |
|
|
the risks and uncertainties normally incident to the pharmaceutical and medical device
industries, including product liability claims; |
|
|
the risks and uncertainties associated with obtaining necessary FDA approvals; |
|
|
the inability to obtain required regulatory approvals for any of our pipeline products; |
36
|
|
unexpected costs and expenses, or our ability to limit costs and expenses as our business
continues to grow; |
|
|
downturns in general economic conditions that negatively affect our dermal restorative and
branded prescription products, and our ability to accurately forecast our financial
performance as a result; |
|
|
failure to comply with our corporate integrity agreement, which could result in substantial
civil or criminal penalties and our being excluded from government health care programs, which
could materially reduce our sales and adversely affect our financial condition and results of
operations; and |
|
|
the inability to successfully integrate newly-acquired entities, such as LipoSonix. |
We undertake no obligation to publicly update forward-looking statements, whether as a result
of new information, future events or otherwise. You are advised, however, to review any future
disclosures contained in the reports that we file with the SEC. Our Annual Report on Form 10-K for
the year ended December 31, 2009, and this Quarterly Report contain discussions of various risks
relating to our business that could cause actual results to differ materially from expected and
historical results, which you should review. You should understand that it is not possible to
predict or identify all such risks. Consequently, you should not consider any such list or
discussion to be a complete set of all potential risks or uncertainties.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures About Market Risk |
As of March 31, 2010, there were no material changes to the information previously reported
under Item 7A in our Annual Report on Form 10-K for the year ended December 31, 2009.
|
|
|
Item 4. |
|
Controls and Procedures |
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of
the Exchange Act) that are designed to ensure that information required to be disclosed in reports
filed by us under the Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms and that such information is accumulated and
communicated to management, including our Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow for timely decisions regarding required disclosure. Our Chief Executive
Officer and Chief Financial Officer, with the participation of other members of management,
evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2010, and
have concluded that, as of such date, our disclosure controls and procedures were effective to
ensure that the information we are required to disclose in reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the SECs rules and forms.
Although the management of the Company, including the Chief Executive Officer and the Chief
Financial Officer, believes that our disclosure controls and internal controls currently provide
reasonable assurance that our desired control objectives have been met, management does not expect
that our disclosure controls or internal controls will prevent all errors and all fraud. A control
system, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent limitations in all control systems,
no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty, and that breakdowns can occur because of
simple error or mistake. Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the controls. The design
of any system of controls is also based in part upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions.
During the three months ended March 31, 2010, there was no change in our internal control over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
37
Part II. Other Information
|
|
|
Item 1. |
|
Legal Proceedings |
The information set forth under Note 15 in our accompanying condensed consolidated financial
statements, included in Part I, Item I of this Report, is incorporated herein by reference.
We operate in a rapidly changing environment that involves a number of risks that could
materially and adversely affect our business, financial condition, prospects, operating results or
cash flows. For a detailed discussion of the risk factors that should be understood by any
investor contemplating investment in our stock, please refer to Part I, Item 1A Risk Factors in
our Annual Report on Form 10-K for the year ended December 31, 2009.
There are no material changes from the risk factors previously disclosed in Part I, Item 1A
Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2009.
38
|
|
|
Exhibit 31.1+
|
|
Certification by the Chief
Executive Officer Pursuant to Section
302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
Exhibit 31.2+
|
|
Certification by the Chief
Financial Officer Pursuant to Section
302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
Exhibit 32.1+
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Certification by the Chief
Executive Officer and the Chief
Financial Officer Pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act
of 2002 |
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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MEDICIS PHARMACEUTICAL CORPORATION |
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Date: May 10, 2010 |
By: |
/s/ Jonah Shacknai
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Jonah Shacknai |
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Chairman of the Board and
Chief Executive Officer
(Principal Executive Officer) |
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Date: May 10, 2010 |
By: |
/s/ Richard D. Peterson
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Richard D. Peterson |
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Executive Vice President
Chief Financial Officer and Treasurer
(Principal Financial and Accounting
Officer) |
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40