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, 2009
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.
Large accelerated filer þ | Accelerated filer o | Non-accelerated filer o (do not check if a smaller reporting company) | 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 7, 2009
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Class A Common Stock $.014 Par Value
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58,845,961 (a)
(a) includes 2,025,994 shares of unvested restricted stock awards |
MEDICIS PHARMACEUTICAL CORPORATION
Table of Contents
2
Part I. Financial Information
Item 1. Financial Statements
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
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March 31, 2009 |
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December 31, 2008 |
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Assets |
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(unaudited) |
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Current assets: |
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Cash and cash equivalents |
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$ |
138,832 |
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$ |
86,450 |
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Short-term investments |
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260,524 |
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257,435 |
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Accounts receivable, net |
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50,913 |
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52,588 |
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Inventories, net |
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25,351 |
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24,226 |
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Deferred tax assets, net |
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66,058 |
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53,161 |
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Other current assets |
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20,879 |
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19,676 |
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Total current assets |
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562,557 |
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493,536 |
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Property and equipment, net |
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26,558 |
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26,300 |
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Intangible assets: |
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Intangible assets related to product line
acquisitions and business combinations |
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267,624 |
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267,624 |
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Other intangible assets |
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7,899 |
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7,752 |
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275,523 |
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275,376 |
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Less: accumulated amortization |
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119,462 |
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113,947 |
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Net intangible assets |
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156,061 |
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161,429 |
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Goodwill |
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156,776 |
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156,762 |
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Deferred tax assets, net |
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73,540 |
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77,149 |
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Long-term investments |
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40,378 |
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55,333 |
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Other assets |
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39 |
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2,925 |
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$ |
1,015,909 |
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$ |
973,434 |
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See accompanying notes to condensed consolidated financial statements.
3
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
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March 31, 2009 |
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December 31, 2008 |
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Liabilities |
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(unaudited) |
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Current liabilities: |
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Accounts payable |
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$ |
43,752 |
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$ |
39,032 |
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Reserve for sales returns |
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68,406 |
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59,611 |
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Income taxes payable |
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4,440 |
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Other current liabilities |
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113,867 |
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87,258 |
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Total current liabilities |
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230,465 |
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185,901 |
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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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Deferred revenue |
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3,542 |
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4,167 |
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Other liabilities |
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8,174 |
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10,346 |
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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: 69,488,936 and 69,396,394 at
March 31, 2009 and December 31, 2008,
respectively |
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969 |
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969 |
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Class B common stock, $0.014 par value; shares
authorized: 1,000,000; issued and outstanding: none |
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Additional paid-in capital |
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664,776 |
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661,703 |
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Accumulated other comprehensive income |
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2,106 |
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2,106 |
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Accumulated earnings |
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280,263 |
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282,284 |
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Less: Treasury stock, 12,711,063 and 12,678,559 shares
at cost at March 31, 2009 and December 31, 2008,
respectively |
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(343,712 |
) |
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(343,368 |
) |
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Total stockholders equity |
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604,402 |
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603,694 |
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$ |
1,015,909 |
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$ |
973,434 |
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See accompanying notes to condensed consolidated financial statements.
4
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share data)
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Three Months Ended |
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March 31, 2009 |
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March 31, 2008 |
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Net product revenues |
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$ |
96,600 |
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$ |
125,054 |
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Net contract revenues |
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3,219 |
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3,849 |
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Net revenues |
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99,819 |
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128,903 |
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Cost of product revenues (1) |
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9,446 |
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11,132 |
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Gross profit |
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90,373 |
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117,771 |
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Operating expenses: |
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Selling, general and administrative (2) |
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70,425 |
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72,062 |
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Research and development (3) |
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13,275 |
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9,189 |
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Depreciation and amortization |
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7,132 |
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6,722 |
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Operating (loss) income |
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(459 |
) |
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29,798 |
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Other expense, net |
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2,873 |
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2,871 |
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Interest and investment income |
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(2,487 |
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(9,199 |
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Interest expense |
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1,054 |
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2,407 |
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(Loss) income before income tax expense |
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(1,899 |
) |
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33,719 |
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Income tax (benefit) expense |
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(2,228 |
) |
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13,194 |
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Net income |
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$ |
329 |
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$ |
20,525 |
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Basic net income per share |
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$ |
0.01 |
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$ |
0.36 |
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Diluted net income per share |
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$ |
0.01 |
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$ |
0.31 |
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Cash dividend declared per common share |
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$ |
0.04 |
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$ |
0.04 |
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Weighted average number of common shares
used in calculating: |
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Basic net income per share |
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56,731 |
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56,358 |
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Diluted net income per share |
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56,867 |
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70,332 |
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(1) amounts exclude amortization of intangible
assets related to acquired products |
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$ |
5,443 |
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$ |
5,286 |
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(2) amounts include share-based
compensation expense |
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$ |
3,733 |
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$ |
4,329 |
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(3) amounts include share-based
compensation expense |
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$ |
139 |
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$ |
61 |
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See accompanying notes to condensed consolidated financial statements.
5
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, 2009 |
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March 31, 2008 |
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Operating Activities: |
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Net income |
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$ |
329 |
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$ |
20,525 |
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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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7,132 |
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6,722 |
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Amortization of deferred financing fees |
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285 |
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Adjustment of impairment of available-for-sale investments |
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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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2,871 |
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Gain on sale of available-for-sale investments, net |
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(10 |
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(117 |
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Share-based compensation expense |
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3,872 |
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4,390 |
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Deferred income tax (benefit) expense |
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(10,680 |
) |
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4,997 |
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Tax expense from exercise of stock options and
vesting of restricted stock awards |
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(644 |
) |
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(354 |
) |
Excess tax benefits from share-based payment arrangements |
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(10 |
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Increase in provision for sales discounts and chargebacks |
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144 |
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519 |
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Accretion (amortization) of (discount)/premium on investments |
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516 |
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(773 |
) |
Changes in operating assets and liabilities: |
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Accounts receivable |
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1,531 |
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(12,284 |
) |
Inventories |
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(1,125 |
) |
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3,277 |
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Other current assets |
|
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(1,203 |
) |
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(6,497 |
) |
Accounts payable |
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4,720 |
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17,863 |
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Reserve for sales returns |
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8,795 |
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(689 |
) |
Income taxes payable |
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4,440 |
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(1,651 |
) |
Other current liabilities |
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26,016 |
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(5,083 |
) |
Other liabilities |
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(1,308 |
) |
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(888 |
) |
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Net cash provided by operating activities |
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45,398 |
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33,103 |
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Investing Activities: |
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Purchase of property and equipment |
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(1,875 |
) |
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(3,898 |
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Payments for purchase of product rights |
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(161 |
) |
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(33 |
) |
Purchase of available-for-sale investments |
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(74,264 |
) |
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(247,967 |
) |
Sale of available-for-sale investments |
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30,494 |
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151,451 |
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Maturity of available-for-sale investments |
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55,029 |
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|
161,975 |
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Net cash provided by investing activities |
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9,223 |
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61,528 |
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Financing Activities: |
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Payment of dividends |
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(2,313 |
) |
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(1,707 |
) |
Excess tax benefits from share-based payment arrangements |
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10 |
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Proceeds from the exercise of stock options |
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|
765 |
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Net cash used in financing activities |
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(2,313 |
) |
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(932 |
) |
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Effect of exchange rate on cash and cash equivalents |
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74 |
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(97 |
) |
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Net increase in cash and cash equivalents |
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52,382 |
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|
93,602 |
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Cash and cash equivalents at beginning of period |
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|
86,450 |
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|
108,046 |
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Cash and cash equivalents at end of period |
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$ |
138,832 |
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$ |
201,648 |
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|
See accompanying notes to condensed consolidated financial statements.
6
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2009
(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, aesthetic and podiatric
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, acne, fungal infections, rosacea, hyperpigmentation,
photoaging, psoriasis, seborrheic dermatitis and cosmesis (improvement in the texture and
appearance of skin). Medicis currently offers 18 branded products. Its primary brands are
PERLANE®, RESTYLANE®,
SOLODYN®, TRIAZ®,
VANOS® and ZIANA®. Medicis entered the non-invasive fat ablation
market with its acquisition of LipoSonix in July 2008. In addition, as discussed in Note
17, on April 29, 2009, the FDA approved DYSPORTTM, which Medicis will market in
the U.S. for the aesthetic indication of glabellar lines.
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, 2008. 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, 2008.
2. SHARE-BASED COMPENSATION
Stock Option and Restricted Stock Awards
At March 31, 2009, 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. Effective July 1, 2005, the
Company adopted Statement of Financial Accounting Standards (SFAS) No. 123R, Share-Based
Payment, using the modified prospective method. Other than restricted stock, no share-based
employee compensation cost has been reflected in net income prior to the adoption of SFAS
No. 123R.
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, 2009, total unrecognized
compensation cost related to stock option
awards, to be recognized as expense subsequent to March 31, 2009, was approximately
$4.4 million and the related weighted-average period over which it is expected to be
recognized is approximately 1.3 years.
7
A summary of stock option activity within the Companys stock-based compensation plans
and changes for the three months ended March 31, 2009 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 of |
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Exercise |
|
Contractual |
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Intrinsic |
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Shares |
|
Price |
|
Term |
|
Value |
Balance at December 31, 2008 |
|
|
10,707,357 |
|
|
$ |
27.98 |
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Granted |
|
|
77,017 |
|
|
$ |
11.28 |
|
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|
|
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Exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(141,367 |
) |
|
$ |
30.83 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2009 |
|
|
10,643,007 |
|
|
$ |
27.82 |
|
|
|
3.5 |
|
|
$ |
952,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable under the Companys share-based compensation plans at March 31,
2009 were 9,703,841, with a weighted average exercise price of $27.38, a weighted average
remaining contractual term of 3.3 years, and an aggregate intrinsic value of $869,010.
A summary of fully vested stock options and stock options expected to vest, based on
historical forfeiture rates, as of March 31, 2009, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
9,736,889 |
|
|
$ |
27.99 |
|
|
|
3.6 |
|
|
$ |
783,300 |
|
Exercisable |
|
|
8,880,402 |
|
|
$ |
27.56 |
|
|
|
3.4 |
|
|
$ |
714,240 |
|
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 |
|
Three Months Ended |
|
|
March 31, 2009 |
|
March 31, 2008 |
Expected dividend yield |
|
|
0.35 |
% |
|
|
0.6 |
% |
Expected stock price volatility |
|
|
0.45 |
|
|
|
0.38 |
|
Risk-free interest rate |
|
|
2.2 |
% |
|
|
3.0 |
% |
Expected life of options |
|
|
7 Years |
|
|
|
7 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, 2009 and 2008 was $5.32 and $8.19, respectively.
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, 2009, 975,173 shares of restricted stock were granted to
certain employees. Share-based compensation expense related to all restricted stock awards
outstanding during the three months
8
ended March 31, 2009 and 2008, was approximately $1.8
million and $1.1 million, respectively. As of March 31, 2009, the total amount of
unrecognized compensation cost related to nonvested restricted stock awards, to be
recognized as expense subsequent to March 31, 2009, was approximately $31.8 million, and the
related weighted-average period over which it is expected to be recognized is approximately
3.6 years.
A summary of restricted stock activity within the Companys share-based compensation
plans and changes for the three months ended March 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant-Date |
Nonvested Shares |
|
Shares |
|
Fair Value |
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2008 |
|
|
1,204,851 |
|
|
$ |
23.38 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
975,173 |
|
|
$ |
11.28 |
|
Vested |
|
|
(92,572 |
) |
|
$ |
28.11 |
|
Forfeited |
|
|
(4,478 |
) |
|
$ |
24.87 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2009 |
|
|
2,082,974 |
|
|
$ |
17.50 |
|
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the three months ended March
31, 2009 and 2008 was approximately $2.6 million and $2.1 million, respectively.
Stock Appreciation Rights
On February 27, 2009, the Company granted 2,013,832 cash-settled stock appreciation
rights (SARs) to certain 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. SFAS No. 123R requires the fair value
of SARs 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, 2009 was approximately $0.2 million. As of
March 31, 2009, the total measured amount of unrecognized compensation cost related to
outstanding SARs, to be recognized as expense subsequent to March 31, 2009, was
approximately $12.7 million, and the related weighted-average period over which it is
expected to be recognized is approximately 4.9 years.
The fair value of each SAR is estimated on the date of the grant, and at the end of
each reporting period, using the Black-Scholes option pricing model with the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
SARs Granted During the |
|
Remeasurement |
|
|
Three Months Ended |
|
as of |
|
|
March 31, 2009 |
|
March 31, 2009 |
Expected dividend yield |
|
|
0.35 |
% |
|
|
1.29 |
% |
Expected stock price volatility |
|
|
0.45 |
|
|
|
0.48 |
|
Risk-free interest rate |
|
|
2.2 |
% |
|
|
2.3 |
% |
Expected life of SARs |
|
|
7.0 Years |
|
|
|
6.9 Years |
|
9
A summary of SARs activity for the three months ended March 31, 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of SARs |
|
Price |
|
Term |
|
Value |
Balance at December 31, 2008 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,013,832 |
|
|
$ |
11.28 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2009 |
|
|
2,013,832 |
|
|
$ |
11.28 |
|
|
|
6.9 |
|
|
$ |
2,195,077 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No SARs were exercisable as of March 31, 2009.
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, 2009, the Company has recorded the estimated fair value in available-for-sale
securities for short-term and long-term investments of approximately $260.5 million and
$40.4 million, respectively.
Available-for-sale and trading securities consist of the following at March 31, 2009
(amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Than- |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Temporary |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Impairment |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate notes and
bonds |
|
$ |
107,353 |
|
|
$ |
472 |
|
|
$ |
(477 |
) |
|
$ |
|
|
|
$ |
107,348 |
|
Federal agency notes
and bonds |
|
|
137,614 |
|
|
|
1,175 |
|
|
|
(30 |
) |
|
|
|
|
|
|
138,759 |
|
Auction rate floating
securities |
|
|
44,575 |
|
|
|
838 |
|
|
|
(429 |
) |
|
|
(6,382 |
) |
|
|
38,602 |
|
Asset-backed securities |
|
|
16,657 |
|
|
|
41 |
|
|
|
(505 |
) |
|
|
|
|
|
|
16,193 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
306,199 |
|
|
$ |
2,526 |
|
|
$ |
(1,441 |
) |
|
$ |
(6,382 |
) |
|
$ |
300,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
During the three months ended March 31, 2009, the gross realized gains on sales of
available-for-sale securities totaled $9,389, while no gross losses were realized. Such
amounts of gains and losses are determined based on the specific identification method. The
net adjustment to unrealized gains during the three months ended March 31, 2009, on
available-for-sale securities included in stockholders equity totaled $74,549. The
amortized cost and estimated fair value of the available-for-sale securities at March 31,
2009, by maturity, are shown below (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
|
|
|
|
|
|
|
|
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
207,391 |
|
|
$ |
207,939 |
|
Due after one year through five years |
|
|
54,233 |
|
|
|
54,361 |
|
Due after five years through 10 years |
|
|
|
|
|
|
|
|
Due after 10 years |
|
|
43,275 |
|
|
|
37,336 |
|
|
|
|
|
|
|
|
|
|
$ |
304,899 |
|
|
$ |
299,636 |
|
|
|
|
|
|
|
|
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, 2009, approximately $40.4 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, 2009, the Companys investments included auction rate floating
securities with a fair value of $38.6 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 and the first quarter of 2009 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. As a result of the continued lack of liquidity of these investments, the
Company recorded an other-than-temporary impairment loss of $6.4 million during the year
ended December 31, 2008 on its auction rate floating securities in other expense, based on
the Companys estimate of the fair value of these investments. The Companys estimate of
the fair value of its auction rate floating securities was based on market information and
assumptions determined by the Companys management, which could change significantly based
on market conditions.
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,
2009 and December 31, 2008, the Company held one auction rate floating security with a par
value of $1.3 million that was subject to the settlement agreement. The Company elected the
irrevocable Fair Value Option treatment under SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities, and adjusted the put option to fair value. The
Company 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 will be recorded in earnings.
11
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, 2009
(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 |
|
$ |
35,419 |
|
|
$ |
270 |
|
|
$ |
6,265 |
|
|
$ |
207 |
|
Federal agency notes and bonds |
|
|
27,643 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
23,265 |
|
|
|
429 |
|
|
|
|
|
|
|
|
|
Asset-backed securities |
|
|
5,125 |
|
|
|
93 |
|
|
|
1,696 |
|
|
|
411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
91,452 |
|
|
$ |
822 |
|
|
$ |
7,961 |
|
|
$ |
618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2009, 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 has the
intent and ability to hold these investments for the time necessary to recover its cost,
which for debt securities may be at maturity.
4. FAIR VALUE MEASUREMENTS
As of March 31, 2009, 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 Revance Therapeutics, Inc. (Revance).
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 recent 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, 2009. 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
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.
As a result of the liquidity issues of the Companys auction rate floating securities,
the Company recorded an other-than-temporary impairment loss of $6.4 million in other
expense during the three months ended December 31, 2008, based on the Companys estimate of
the fair value of these investments. The auction rate floating securities held by the
Company at March 31, 2009 and December 31, 2008, totaling $38.6 million and $38.2 million,
respectively, were in securities collateralized by student loan portfolios. These
securities were included in long-term investments at March 31, 2009 and December 31, 2008 in
the accompanying condensed consolidated balance sheets. As of March 31, 2009, the Company
continued to earn interest on virtually all of its auction rate floating securities. Any
future fluctuation in fair value related to the auction rate floating securities classified
as available-for-sale that the Company deems to be temporary, would be recorded to
accumulated other comprehensive (loss) income. If the
12
Company determines that any future decline in fair value of its
available-for-sale securities was other than temporary, it would record a charge to earnings
as appropriate.
The Company estimates changes in the net realizable value of its investment in Revance
based on a hypothetical liquidation at book value approach (see Note 5). 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
as of March 31, 2009.
The Companys assets measured at fair value on a recurring basis subject to the
disclosure requirements of SFAS No. 157 at March 31, 2009, 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, 2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
$ |
38,602 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
38,602 |
|
Other available-for-sale securities |
|
|
262,300 |
|
|
|
262,300 |
|
|
|
|
|
|
|
|
|
Investment in Revance |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
300,902 |
|
|
$ |
262,300 |
|
|
$ |
|
|
|
$ |
38,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents the Companys assets measured at fair value on a recurring
basis using significant unobservable inputs (Level 3) as defined in SFAS No. 157 for the
three months ended March 31, 2009 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
Investment |
|
|
|
Floating |
|
|
in |
|
|
|
Securities |
|
|
Revance |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
38,225 |
|
|
$ |
2,887 |
|
Transfers to (from) Level 3 |
|
|
|
|
|
|
|
|
Total gains included in interest and
investment income |
|
|
5 |
|
|
|
|
|
Total gains (losses) included in other expense |
|
|
13 |
|
|
|
(2,887 |
) |
Total gains included in other
comprehensive income |
|
|
409 |
|
|
|
|
|
Purchases and settlements (net) |
|
|
(50 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2009 |
|
$ |
38,602 |
|
|
$ |
|
|
|
|
|
|
|
|
|
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 expected to be used by Revance primarily
for the development of the
13
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 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 United States. 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 estimates 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 is available for these purposes (such as the completion of
an equity financing by Revance). During the three months ended March 31, 2009 and the three
months ended March 31, 2008, the Company reduced the carrying value of its investment in
Revance by approximately $2.9 million and $2.9 million, respectively, 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 and March 31, 2008. Such amounts
were recognized as other expense during the three months ended March 31, 2009 and three
months ended March 31, 2008, respectively. Upon the recognition of the $2.9 million
reduction of the Companys investment in Revance during the three months ended March 31,
2009, the Companys investment in Revance as of March 31, 2009, is $0.
A business entity is subject to the consolidation rules of FASB Interpretation No. 46,
Consolidation of Variable Interest Entities an Interpretation of Accounting Research
Bulletin No. 51 (FIN 46) 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 criteria set
forth in FIN 46. FIN 46 also requires disclosures 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 COLLABORATION WITH IMPAX
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 Abbreviated New Drug Application (ANDA) #90-024.
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® intellectual property rights belonging to the Company upon the
occurrence of specific events. Upon launch of its generic
14
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, the Company paid IMPAX $5.0 million upon the achievement of a clinical
milestone, in accordance with terms of the agreement. In addition, the Company will be
required to pay up to $18.0 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 Medicis 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 the three months ended December 31, 2008, and the $5.0 million
clinical milestone achievement payment was recognized as a charge to research and
development expense during the three months ended March 31, 2009.
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
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 LOPROX®,
PERLANE®, RESTYLANE® and VANOS®. The non-dermatological
product lines include AMMONUL® and BUPHENYL®. The non-dermatological
field also includes contract revenues associated with licensing agreements and authorized
generics, and LipoSonix revenues.
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.
15
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, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
Acne and acne-related dermatological products |
|
$ |
66,453 |
|
|
$ |
80,134 |
|
Non-acne dermatological products |
|
|
23,473 |
|
|
|
39,091 |
|
Non-dermatological products |
|
|
9,893 |
|
|
|
9,678 |
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
99,819 |
|
|
$ |
128,903 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
March 31, |
|
|
2009 |
|
2008 |
|
|
|
Acne and acne-related dermatological products |
|
|
67 |
% |
|
|
62 |
% |
Non-acne dermatological products |
|
|
23 |
|
|
|
30 |
|
Non-dermatological products |
|
|
10 |
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
8. INVENTORIES
Except for the LipoSonix technology, the Company 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 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, 2009 and December 31, 2008, there
was $0.9 million and $1.1 million, respectively, of costs capitalized into inventory for
products that have not yet received regulatory approval.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
9,498 |
|
|
$ |
7,234 |
|
Finished goods |
|
|
16,736 |
|
|
|
18,407 |
|
Valuation reserve |
|
|
(883 |
) |
|
|
(1,415 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
25,351 |
|
|
$ |
24,226 |
|
|
|
|
|
|
|
|
16
9. OTHER CURRENT LIABILITIES
Other current liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Accrued incentives |
|
$ |
11,502 |
|
|
$ |
18,910 |
|
Managed care and Medicaid
reserves |
|
|
31,657 |
|
|
|
16,956 |
|
Accrued consumer rebate and loyalty
programs |
|
|
46,316 |
|
|
|
28,449 |
|
Deferred revenue |
|
|
3,679 |
|
|
|
3,341 |
|
Other accrued expenses |
|
|
20,713 |
|
|
|
19,602 |
|
|
|
|
|
|
|
|
|
|
$ |
113,867 |
|
|
$ |
87,258 |
|
|
|
|
|
|
|
|
Included in deferred revenue as of March 31, 2009 and December 31, 2008 was $0.9
million and $0.7 million, respectively, associated with the deferral of the recognition of
revenue and related cost of revenue for certain sales of inventory into the distribution
channel that are in excess of eight (8) weeks of projected demand.
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, 2009 or December 31, 2008. 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 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. Pursuant to SFAS No. 48,
Classification of Obligations That Are Callable by the Creditor, 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; |
17
|
|
|
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, 2009 or December 31, 2008. 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 is amortizing these costs over the first five-year Put period,
which runs 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 $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, 2009
and December 31, 2008.
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; |
18
|
|
|
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, 2009 and December 31, 2008, 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 under SFAS 123R 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 in accordance with FIN 48,
Accounting for Uncertainty in Income Taxes an Interpretation of FASB Statement No. 109.
Under FIN 48, tax benefits are recognized 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, 2009, the Company has an unrealized tax loss of $21.0 million related to
the Companys option to acquire Revance or license Revances 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, 2009, the Company
has recorded a valuation allowance of $7.6 million against the deferred tax asset associated
with this unrealized tax loss 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, 2009 and March 31, 2008, the Company made net
tax payments of $1.5 million and $36.9 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
19
through fiscal 2004. The Internal Revenue Service has recently informed the Company that the tax return for the period ending
December 31, 2007 has been selected for a limited scope examination.
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 2004 forward are open under the statute of
limitation.
At December 31, 2008, the Company had $2.5 million in unrecognized tax benefits, the
recognition of which would have a favorable effect of $2.1 million on the Companys
effective tax rate. The amount of unrecognized tax benefits decreased $1.4 million from
$2.5 million to $1.1 million during the three months ended March 31, 2009 due to statute
closures. Recognition of the $1.1 million unrecognized tax benefits would have a favorable
effect of $0.7 million on the Companys effective tax rate. During the next twelve months,
the Company estimates that the amount of unrecognized tax benefits will not change.
The Company recognizes accrued interest and penalties, if applicable, related to
unrecognized tax benefits in income tax expense. The Company had approximately $165,000 and
$290,000 for the payment of interest and penalties accrued (net of tax benefit) at March 31,
2009 and December 31, 2008, respectively.
12. DIVIDENDS DECLARED ON COMMON STOCK
On March 11, 2009, the Company declared a cash dividend of $0.04 per issued and
outstanding share of its Class A common stock payable on April 30, 2009 to stockholders of
record at the close of business on April 1, 2009. The $2.4 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, 2009. 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, 2009 and 2008 was $0.3 million and $21.5 million, respectively.
20
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, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
329 |
|
|
$ |
20,525 |
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
56,731 |
|
|
|
56,358 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share |
|
$ |
0.01 |
|
|
$ |
0.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
329 |
|
|
$ |
20,525 |
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
Tax-effected interest expense and
issue costs related to Old Notes |
|
|
|
|
|
|
666 |
|
Tax-effected interest expense and
issue costs related to New Notes |
|
|
|
|
|
|
851 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income assuming dilution |
|
$ |
329 |
|
|
$ |
22,042 |
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares |
|
|
56,731 |
|
|
|
56,358 |
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Old Notes |
|
|
|
|
|
|
5,823 |
|
New Notes |
|
|
|
|
|
|
7,325 |
|
Stock options and restricted stock |
|
|
136 |
|
|
|
826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares assuming dilution |
|
|
56,867 |
|
|
|
70,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share |
|
$ |
0.01 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
Diluted net income per common share must be calculated using the if-converted method
in accordance with EITF 04-8, Effect of Contingently Convertible Debt on Earnings per Share.
Diluted net income per share 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.
The diluted net income per common share computation for the three months ended March
31, 2009 and 2008 excludes 12,106,591 and 7,667,494 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.
21
In June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted
in Share-Based Payment Transactions Are Participating Securities. In FSP 03-6-1, unvested
share-based payment awards that contain rights to receive nonforfeitable dividends or
dividend equivalents (whether paid or unpaid) are participating securities, and thus, should
be 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 shareholders. The Company
adopted FASB Staff Position No. EITF 03-6-1 on January 1, 2009, and it did not have a
material impact on its disclosure of earnings per share.
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 SFAS 146, Accounting for Costs
Associated with Exit or Disposal Activities, a liability for the costs associated with an
exit or disposal activity is recognized when the liability is incurred. In accordance with
SFAS 146, 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.
As of March 31, 2009, approximately $3.5 million of lease exit costs remain accrued and
are expected to be paid by December 2010 of which $1.9 million is classified in other
current liabilities and $1.6 million is classified in other 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, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2008 |
|
to Expense |
|
Made |
|
from Sublease |
|
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease exit costs
liability |
|
$ |
3,996,102 |
|
|
$ |
65,737 |
|
|
$ |
(534,528 |
) |
|
$ |
|
|
|
$ |
3,527,311 |
|
Medicaid Drug Rebates
In April 2009, the Company completed a voluntary review of pricing data submitted to
the Medicaid Drug Rebate Program (the Program) for the period from the first quarter of
2006 through the fourth quarter of 2007. The review identified certain corrective actions
that were needed in relation to the reviewed data. The Company expects that the corrective
actions, when implemented, would result in an increase to the Companys rebate liability
under the Program in the amount of approximately $3.1 million for the eight-quarter period
reviewed. The Company has disclosed the results of the review and revised rebate liability
to the Centers for Medicare and Medicaid Services (CMS), which administers the Program,
and is awaiting CMS instruction as to whether and when to re-file the revised pricing data.
The Companys submission to CMS also included a request that CMS approve a change in drug
category for certain Company products. If CMS does not accept the Companys request for
this change, the Company may owe additional Medicaid rebates which would result in
additional liability under the Program. Upon completion of CMSs review of the Companys submission, the Company will evaluate the
impact that CMSs conclusions will have on the Companys liability under related drug rebate
agreements with various states and the Public Health Service Drug Pricing Program. As of
March 31, 2009, the Company accrued $3.1 million for the 2006 and 2007 liability, which was recognized as a reduction of net revenues during the three months ended March 31, 2009.
22
Department of Defense/TRICARE
On March 17, 2009, the Department of Defense (DoD) issued a Final Rule (the Rule)
implementing Section 703 of the National Defense Authorization Act of 2008. The Rule
establishes a program under which DoD will seek Federal Ceiling Price-based refunds, or
rebates, from drug manufacturers on TRICARE retail pharmacy utilization. Under the Rule,
effective May 26, 2009, DoD seeks refunds, or rebates, on TRICARE Retail Pharmacy Program
prescriptions filled from January 28, 2008 forward. The Rule also provides that an
agreement from the manufacturer to honor the new pricing standards is required to include
the manufacturers product(s) on the DoD uniform formulary and make that drug available
through retail network pharmacies without prior authorization. Among other things, the Rule
further provides that manufacturers may apply for compromise or waivers of amounts due. As
a result of this Final Rule, the Companys rebate liability as of March 31, 2009 for 2008
utilization is approximately $1.6 million, and the estimated rebate liability for the first
quarter of 2009 is approximately $0.8 million. It is possible that, pursuant to the
compromise or waiver process set forth in the Rule, DoD will agree to accept a lesser sum
for the 2008 and first quarter of 2009 periods. As of March 31, 2009 the Company accrued
$2.4 million for the 2008 and first quarter of 2009 liability, which was recognized as a
reduction of net revenues during the three months ended March 31, 2009.
Legal Matters
On January 13, 2009, the Company filed suit against Mylan, Inc., Matrix Laboratories
Ltd., Matrix Laboratories Inc., Sandoz, Inc., and Barr Laboratories, Inc. (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 U.S. Patent No. 5,908,838 (the 838 patent) by submitting to the FDA their respective ANDAs for generic versions of SOLODYN®.
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) whereby all legal disputes between the Company and Teva
relating to SOLODYN® were terminated and where 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 Medicis and Matrix Laboratories Inc. without prejudice, pursuant to a stipulation between Medicis and
Matrix Laboratories Inc.
On January 21, 2009, the Company received a letter from a 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
stockholder will commence a derivative action on behalf of the Company. The Companys Board
of Directors is reviewing the letter and has 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 does 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 any other appropriate action to be taken.
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 complaints name as defendants Medicis Pharmaceutical Corp. and the
Companys Chief Executive Officer and Chairman of the Board, Jonah Shacknai, the Companys
Chief Financial Officer, Executive Vice President and Treasurer, Richard D. Peterson, and
the Companys Chief Operating Officer and Executive Vice President,
23
Mark A. Prygocki. Plaintiffs claims arise in connection with the restatement of the Companys annual,
transition, and quarterly periods in fiscal years 2003 through 2007 and the first and second
quarters of 2008. The complaints allege violations of federal securities laws, Sections
10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, based on alleged
material misrepresentations to the market that had the effect of artificially inflating the
market price of the Companys stock. The plaintiffs seek to recover unspecified damages and
costs, including counsel and expert fees. The Court has consolidated these actions into a
single proceeding, appointed a lead plaintiff and lead plaintiffs counsel, and ordered the
lead plaintiff to file a single, consolidated complaint by May 18, 2009. The Company
intends 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.
On April 30, 2008, the Company received notice from Perrigo Israel Pharmaceuticals Ltd.
(Perrigo Israel), a generic pharmaceutical company, that it had filed an ANDA with the FDA
for a generic version of the Companys VANOS® fluocinonide cream 0.1%. Perrigo
Israels notice indicated that it was challenging only one of the two patents that the
Company listed with the FDA for VANOS® Cream. On June 6, 2008, the Company filed
a complaint for patent infringement against Perrigo Israel and its domestic corporate parent
Perrigo Company in the United States District Court for the Western District of Michigan,
Civil Action No. 1:08-cv-0539-PLM. The complaint asserts that Perrigo Israel and Perrigo
Company have infringed both of the Companys patents for VANOS® Cream (United
States Patent Nos. 6,765,001 and 7,220,424). Perrigo Israel and Perrigo Company filed a
joint Answer on November 4, 2008. As discussed further in Note 17, Subsequent Events, on
April 8, 2009, the Company, Perrigo Israel and Perrigo Company agreed to terminate all legal
disputes between them relating to the Companys VANOS® fluocinonide Cream. On
April 18, 2009, the Court formally dismissed the action.
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 December 2007, the FASB issued SFAS No. 141R, Business Combinations, which replaces
SFAS No. 141 and establishes principles and requirements for how an acquirer in a business
combination recognizes and measures in its financial statements the identifiable assets
acquired, the liabilities assumed and any controlling interest. It also established
principles and requirements for how an acquirer in a business combination recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain
purchase, and determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business combination. SFAS
No. 141R provides for the following changes from SFAS No. 141: 1) an acquirer will record
all assets and liabilities of acquired business, including goodwill, at fair value,
regardless of the level of interest acquired; 2) certain contingent assets and liabilities
acquired will be recognized at fair value at the acquisition date; 3) contingent
consideration will be recognized at fair value on the acquisition date with changes in fair
value to be recognized in earnings; 4) acquisition-related transaction and restructuring
costs will be expensed as incurred rather than treated as part of the cost of the
acquisition and included in the amount recorded for assets acquired; 5) reversals of
valuation allowances related to acquired deferred tax assets and changes to acquired income tax uncertainties will be recognized in earnings; and 6)
when making adjustments to finalize initial accounting, acquirers will revise any previously
issued post-acquisition financial information in future financial statements to reflect any
adjustments as if they occurred on the acquisition date. SFAS No. 141R applies
prospectively to business combinations the Company enters into, if any, for which the
acquisition date is on or after January 1, 2009. The Company adopted SFAS No. 141R on
January 1, 2009, and the impact of SFAS No. 141R, if any, on the Companys consolidated
results of operations and financial condition will depend on the nature of business
combinations the Company enters into, if any, subsequent to January 1, 2009.
24
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements an amendment of Accounting Research Bulletin No. 51.
SFAS No. 160 establishes new accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a subsidiary. Specifically, this
statement requires the recognition of a noncontrolling interest, or minority interest, as
equity in the consolidated financial statements and separate from the parents equity. The
amount of net income attributable to the noncontrolling interest will be included in
consolidated net income on the face of the statement of operations. SFAS No. 160 clarifies
that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains it controlling financial
interest. In addition, this statement requires that a parent recognize a gain or loss in
net income when a subsidiary is deconsolidated. Such gain or loss will be measured using
the fair value of the noncontrolling equity investment on the deconsolidation date. SFAS
No. 160 also includes expanded disclosure requirements regarding the interests of the parent
and its noncontrolling interest. SFAS No. 160 is effective for fiscal years beginning on or
after December 15, 2008. The Company adopted SFAS No. 160 on January 1, 2009, and it did
not have a material impact on its consolidated results of operations and financial
condition.
In December 2007, the EITF reached a consensus on EITF 07-01, Accounting for
Collaborative Agreements. EITF 07-01 prohibits companies from applying the equity method of
accounting to activities performed outside a separate legal entity by a virtual joint
venture. Instead, revenues and costs incurred with third parties in connection with the
collaborative arrangement should be presented gross or net by the collaborators based on the
criteria in EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an
Agent, and other applicable accounting literature. The consensus should be applied to
collaborative arrangements in existence at the date of adoption using a modified
retrospective method that requires reclassification in all periods presented for those
arrangements still in effect at the transition date, unless that application is
impracticable. The consensus is effective for fiscal years beginning after December 15,
2008. The Company adopted EITF 07-01 on January 1, 2009, and it did not have a material
impact on its consolidated results of operations and financial condition.
In April 2008, the FASB issued FSP 142-3, Determination of the Useful Life of
Intangible Assets. FSP 142-3 amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. FSP 142-3 is
effective for fiscal years beginning after December 15, 2008. The Company adopted FSP 142-3
on January 1, 2009, and it did not have a material impact on its consolidated results of
operations and financial condition.
In May 2008, the FASB issued FSP APB 14-1, Accounting for Convertible Debt Instruments
That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement). FSP APB
14-1 clarifies the accounting for convertible debt instruments that may be settled in cash
(including partial cash settlement) upon conversion. FSP APB 14-1 specifies that issuers of
such instruments should separately account for the liability and equity components of
certain convertible debt instruments in a manner that reflects the issuers nonconvertible
debt borrowing rate when interest cost is recognized. FSP APB 14-1 requires bifurcation of
a component of the debt, classification of that component in equity and the accretion of the
resulting discount on the debt to be recognized as part of interest expense. FSP APB 14-1
requires retrospective application to the terms of instruments as they existed for all
periods presented. FSP APB 14-1 is effective for fiscal years beginning after December 15,
2008, and early adoption is not permitted. The Company adopted FSP APB 14-1 on January 1,
2009, and it did not have a material impact on its consolidated results of operations and
financial condition.
In June 2008, the FASB reached a consensus on EITF 07-5, Determining Whether an
Instrument (or Embedded Feature) Is Indexed to an Entitys Own Stock. EITF 07-5 addresses
the determination of whether an instrument (or embedded feature) is indexed to an entitys
own stock. EITF 07-5 is effective for fiscal years beginning after December 15, 2008. The
Company adopted EITF 07-5 on January 1, 2009, and it did not have a material impact on its
consolidated results of operations and financial condition.
In June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted
in Share-Based Payment Transactions Are Participating Securities. In FSP 03-6-1, unvested
share-based payment awards that contain rights to receive nonforfeitable dividends or
dividend equivalents (whether
25
paid or unpaid) are participating securities, and thus, should be 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 shareholders. The Company
adopted FASB Staff Position No. EITF 03-6-1 on January 1, 2009, and it did not have a
material impact on its disclosure of earnings per share.
In April 2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, Recognition and
Presentation of Other-Than-Temporary Impairments, which amends SFAS No. 115 and FSP FAS No.
115-1 and FSP FAS No. 124-1, and improves the presentation and disclosure of
other-than-temporary impairments on debt and equity securities in the financial statements.
FSP FAS No. 115-2 and FAS No. 124-2 are effective for interim and annual reporting periods
ending after June 15, 2009. The Company does not expect the adoption of FSP FAS No. 115-2
and FAS No. 124-2 to have a material impact on its consolidated results of operations and
financial condition.
In April 2009, the FASB issued FSP FAS No. 157-4, Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That Are Not Orderly, which provides additional guidance for
estimating fair value in accordance with SFAS No. 157, Fair Value Measurements, when the
volume and level of activity for the asset or liability have significantly decreased. This
FSP also includes guidance on identifying circumstances that indicate a transaction is not
orderly and applies to all assets and liabilities within the scope of accounting
pronouncements that require or permit fair value measurements, except in paragraphs 2 and 3
of SFAS No. 157. FSP FAS No. 157-4 is effective for interim and annual reporting periods
ending after June 15, 2009. The Company does not expect the adoption of FSP FAS No. 157-4 to
have a material impact on its consolidated results of operations and financial condition.
In April 2009, the FASB issued FSP FAS No. 107-1 and APB No. 28-1, Interim Disclosures
about Fair Value of Financial Instruments, which amends the disclosure requirements of SFAS
No. 107 and APB No. 28 and requires disclosure about the fair value of its financial
instruments whenever it issues summarized financial information for interim reporting
periods. FSP FAS No. 107-1 and APB Opinion No. 28-1 are effective for financial statements
issued for interim reporting periods ending after June 15, 2009. The Company does not
expect the adoption of FSP FAS No. 107-1 and APB Opinion No. 28-1 to have a material impact
on its consolidated results of operations and financial condition.
17. SUBSEQUENT EVENTS
License and Settlement Agreement and Joint Development Agreement with Perrigo
On April 8, 2009, the Company entered into a License and Settlement Agreement (the
License and Settlement Agreement) and a Joint Development Agreement (the Joint
Development Agreement) with Perrigo Israel Pharmaceuticals Ltd. Perrigo Company was also a
party to the License and Settlement Agreement. Perrigo Israel Pharmaceuticals Ltd. and
Perrigo Company are collectively referred to as Perrigo.
In connection with the License and Settlement Agreement, the Company and Perrigo agreed
to terminate all legal disputes between them relating to the Companys VANOS®
fluocinonide Cream. In addition, Perrigo confirmed that certain of the Companys patents relating to
VANOS® are valid and enforceable, and cover Perrigos activities relating to its
generic product under ANDA No. 090256. Further, subject to the terms and conditions
contained in the License and Settlement Agreement:
|
|
|
the Company granted Perrigo, effective December 15, 2013, or earlier upon the
occurrence of certain events, a license to make and sell generic versions of the
existing VANOS® products; and |
|
|
|
|
when Perrigo does commercialize generic versions of VANOS® products,
Perrigo will pay the Company a royalty based on sales of such generic products. |
Pursuant to the Joint Development Agreement, subject to the terms and conditions
contained therein:
26
|
|
|
the Company and Perrigo will collaborate to develop a novel proprietary product; |
|
|
|
|
the Company has the sole right to commercialize the novel proprietary product; |
|
|
|
|
if and when a New Drug Application (NDA) for a novel proprietary product is
submitted to the FDA, the Company and Perrigo shall enter into a commercial supply
agreement pursuant to which, among other terms, for a period of three years
following approval of the NDA, Perrigo would exclusively supply to the Company all
of the Companys novel proprietary product requirements in the U.S.; |
|
|
|
|
the Company will make an up-front $3.0 million payment to Perrigo and will make
additional payments to Perrigo of up to $5.0 million upon the achievement of
certain development, regulatory and commercialization milestones; and |
|
|
|
|
the Company will pay to Perrigo royalty payments on sales of the novel
proprietary product. |
The $3.0 million payment will be recognized as research and development expense during
the three months ended June 30, 2009.
FDA Approval of DYSPORTTM
On April 29, 2009, the FDA approved the Biologics License Application for
DYSPORTTM, an acetylcholine release inhibitor and a neuromuscular blocking agent.
The approval includes two separate indications, the treatment of cervical dystonia in
adults to reduce the severity of abnormal head position and neck pain, and the temporary
improvement in the appearance of moderate to severe glabellar lines in adults younger than
65 years of age. RELOXIN®, which was the proposed U.S. name for Ipsens
botulinum toxin product for aesthetic use, will be marketed under the name of
DYSPORTTM. Ipsen will market DYSPORTTM in the U.S. for the
therapeutic indication (cervical dystonia), while Medicis will market DYSPORTTM
in the U.S. for the aesthetic indication (glabellar lines).
In March 2006, Ipsen granted the Company the rights to develop, distribute and
commercialize Ipsens botulinum toxin product for aesthetic use in the U.S., Canada and
Japan. In accordance with the agreement, the Company will pay Ipsen $75.0 million during
the second quarter of 2009 as a result of the approval by the FDA. The $75.0 million
payment will be capitalized into intangible assets in the Companys consolidated balance
sheet. The Company will pay Ipsen a royalty based on sales and a supply price, the total of
which is equivalent to approximately 30% of net sales as defined under the agreement.
27
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,
aesthetic and podiatric 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 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 LOPROX®,
PERLANE®, RESTYLANE® and VANOS®. Our non-dermatological
product lines include AMMONUL® and BUPHENYL®. Our non-dermatological
field also includes contract revenues associated with licensing agreements and authorized
generic agreements, and LipoSonix revenues.
Financial Information About Segments
We operate in one significant 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: PERLANE®,
RESTYLANE®, SOLODYN®, TRIAZ®, VANOS® and
ZIANA®. We believe that sales of our primary products, along with sales of
DYSPORTTM, which was approved by the FDA on April 29, 2009, will constitute a
significant portion of our revenue for 2009.
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 podiatrists and the leading plastic surgeons in the
U.S. We rely on third parties to manufacture our products.
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
28
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 recognize revenue at the time of shipment
to the customer, or at the time of receipt by the customer, net of estimated provisions.
Beginning in the second quarter of 2009, we will recognize revenue on our aesthetics
products, including RESTYLANE®, PERLANE® and DYSPORTTM,
upon the shipment from our exclusive distributor to physicians. 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, 2009 and affected our results of
operations, our cash flows and our financial condition:
|
|
Tevas launch of a generic to SOLODYN®, our settlement agreement
with Teva, and the impact of the launch on our sales reserves; |
|
|
|
Adjustments to Medicaid drug rebate and DoD/TRICARE liabilities; |
|
|
|
Clinical milestone payment related to our collaboration with IMPAX; and |
|
|
|
Reduction in the carrying value of our investment in Revance. |
29
Tevas launch of a generic to SOLODYN®, our settlement agreement with Teva, and
the impact of the launch on our sales reserves
On March 17, 2009, Teva Pharmaceutical Industries Ltd. (Teva) was granted final
approval by the FDA for its ANDA #65-485 to market its generic version of 45mg, 90mg and
135mg SOLODYN® Tablets. Teva commenced shipment of this product immediately
after the FDAs approval of the ANDA.
On March 18, 2009, we entered into a Settlement Agreement with Teva whereby all legal
disputes between us and Teva relating to SOLODYN® were terminated. Pursuant to
the agreement, Teva confirmed that our patents relating to SOLODYN® are valid and
enforceable, and cover Tevas activities relating to its generic SOLODYN®
product. As part of the settlement, Teva agreed to immediately stop all further shipments
of its generic SOLODYN® product. We agreed to release Teva from liability
arising from any prior sales of its generic SOLODYN® product, which were not
authorized by Medicis. Under terms of the agreement, Teva has the option to market its
generic versions of 45mg, 90mg and 135mg SOLODYN® Tablets under the
SOLODYN® intellectual property rights belonging to us in November 2011, or
earlier under certain conditions.
Tevas shipment of its generic SOLODYN® product upon FDA approval, but prior
to the consummation of the Settlement Agreement with us on March 18, 2009 caused wholesalers
to reduce ordering levels for SOLODYN®, and caused us to increase our reserves
for sales returns and consumer rebates. As a result, net revenues of SOLODYN®
during the three months ended March 31, 2009 decreased as compared to the three months ended
March 31, 2008 and as compared to the three months ended December 31, 2008.
Adjustments to Medicaid drug rebate and Department of Defense/TRICARE liabilities
In April 2009, we completed a voluntary review of pricing data submitted to the
Medicaid Drug Rebate Program (the Program) for the period from the first quarter of 2006
through the fourth quarter of 2007. The review identified certain corrective actions that
were needed in relation to the reviewed data. We expect that the corrective actions, when
implemented, would result in an increase to our rebate liability under the Program in the
amount of approximately $3.1 million for the eight-quarter period reviewed. We have
disclosed the results of the review and revised rebate liability to the Centers for Medicare
and Medicaid Services (CMS), which administers the Program, and are awaiting CMS
instruction as to whether and when to re-file the revised pricing data. Our submission to
CMS also included a request that CMS approve a change in drug category for certain of our
products. If CMS does not accept our request for this change, we may owe additional
Medicaid rebates which would result in additional liability under the Program. Upon
completion of CMSs review of our submission, we will evaluate the impact that CMSs
conclusions will have on our liability under related drug rebate agreements with various
states and the Public Health Service Drug Pricing Program. As of March 31, 2009, we accrued
$3.1 million for the 2006 and 2007 liability, which was recognized as a reduction of net
revenues during the three months ended March 31, 2009.
On March 17, 2009, the Department of Defense (DoD) issued a Final Rule (the Rule)
implementing Section 703 of the National Defense Authorization Act of 2008. The Rule
establishes a program under which DoD will seek Federal Ceiling Price-based refunds, or
rebates, from drug manufacturers on TRICARE retail pharmacy utilization. Under the Rule,
effective May 26, 2009, DoD seeks refunds, or rebates, on TRICARE Retail Pharmacy Program
prescriptions filled from January 28, 2008 forward. The Rule also provides that an
agreement from the manufacturer to honor the new pricing standards is required to include
the manufacturers product(s) on the DoD uniform formulary and make that drug available
through retail network pharmacies without prior authorization. Among other things, the Rule
further provides that manufacturers may apply for compromise or waivers of amounts due. As
a result of this Final Rule, our rebate liability as of March 31, 2009 for 2008 utilization
is approximately $1.6 million, and the estimated rebate liability for the first quarter of
2009 is approximately $0.8 million. It is possible that, pursuant to the compromise or
waiver process set forth in the Rule, DoD will agree to accept a lesser sum for the 2008 and
first quarter of 2009 periods. As of March 31, 2009 we accrued $2.4 million for the
2008 and first quarter of 2009 liability, which was recognized as a reduction of net
revenues during the three months ended March 31, 2009.
30
Clinical milestone payment related to our collaboration with IMPAX
On November 26, 2008, we 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, we and IMPAX agreed to terminate all legal disputes
between us relating to SOLODYN®. Additionally, under terms of the License and
Settlement Agreement, IMPAX confirmed that our patents relating to SOLODYN® are
valid and enforceable, and cover IMPAXs activities relating to its generic product under
ANDA #90-024. 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® intellectual property rights belonging to us upon the occurrence of
specific events. Upon launch of its generic formulations of SOLODYN®, IMPAX may
be required to pay us 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, we and IMPAX will collaborate on the development of five strategic dermatology
product opportunities, including an advanced-form SOLODYN® product. Under terms
of the agreement, we made an initial payment of $40.0 million upon execution of the
agreement. During the three months ended March 31, 2009, we paid IMPAX $5.0 million upon
the achievement of a clinical milestone, in accordance with terms of the agreement. In
addition, we are required to pay up to $18.0 million upon successful completion of certain
other clinical and commercial milestones. We will also make royalty payments based on sales
of the advanced-form SOLODYN® product if and when it is commercialized by us upon
approval by the FDA. We 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 the three months ended December 31, 2008, and the $5.0 million clinical milestone
achievement payment was recognized as a charge to research and development expense during
the three months ended March 31, 2009.
Reduction in the carrying value of our investment in Revance
On December 11, 2007, we announced a strategic collaboration with Revance Therapeutics,
Inc. (Revance), a privately-held, venture-backed development-stage company, whereby we
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 our
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 our $20.0 million payment, we 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 is expected to be used by Revance primarily for the
development of the product. Approximately $12.0 million of the $20.0 million payment
represents the fair value of the investment in Revance at the time of the investment and was
included in other long-term assets in our condensed consolidated balance sheets as of
December 31, 2007. The remaining $8.0 million, which is non-refundable and is expected to
be utilized in the development of the new product, represents 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.
We estimate the net realizable value of the Revance investment based on a hypothetical
liquidation at book value approach as of the reporting date, unless a quantitative valuation
metric is available for these purposes (such as the completion of an equity financing by
Revance).
During 2008, we reduced the carrying value of our investment in Revance and recorded a
related charge to earnings of approximately $9.1 million 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 December 31, 2008. Additionally, during the three months ended March
31, 2009, we reduced the carrying value of our 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 as of March 31, 2009. We recognized the $2.9 million as other expense in our
condensed consolidated statement of
31
operations during the three months ended March 31, 2009.
Upon the recognition of the $2.9 million reduction of our investment in Revance during the
three months ended March 31, 2009, our investment in Revance as of March 31, 2009, is $0.
Subsequent Events
License and Settlement Agreement and Joint Development Agreement with Perrigo
On April 8, 2009, we entered into a License and Settlement Agreement (the License and
Settlement Agreement) and a Joint Development Agreement (the Joint Development Agreement)
with Perrigo Israel Pharmaceuticals Ltd. Perrigo Company was also a party to the License
and Settlement Agreement. Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company are
collectively referred to as Perrigo.
In connection with the License and Settlement Agreement, we and Perrigo agreed to
terminate all legal disputes between them relating to our VANOS® fluocinonide
Cream. In addition, Perrigo confirmed that certain of our patents relating to
VANOS® are valid and enforceable, and cover Perrigos activities relating to its
generic product under ANDA No. 090256. Further, subject to the terms and conditions
contained in the License and Settlement Agreement:
|
|
|
we granted Perrigo, effective December 15, 2013, or earlier upon the occurrence
of certain events, a license to make and sell generic versions of the existing
VANOS® products; and |
|
|
|
|
when Perrigo does commercialize generic versions of VANOS® products,
Perrigo will pay us a royalty based on sales of such generic products. |
Pursuant to the Joint Development Agreement, subject to the terms and conditions
contained therein:
|
|
|
we and Perrigo will collaborate to develop a novel proprietary product; |
|
|
|
|
we have the sole right to commercialize the novel proprietary product; |
|
|
|
|
if and when a New Drug Application (NDA) for a novel proprietary product is
submitted to the FDA, we and Perrigo shall enter into a commercial supply
agreement pursuant to which, among other terms, for a period of three years
following approval of the NDA, Perrigo would exclusively supply to us all of our
novel proprietary product requirements in the U.S.; |
|
|
|
|
we will make an up-front $3.0 million payment to Perrigo and will make
additional payments to Perrigo of up to $5.0 million upon the achievement of
certain development, regulatory and commercialization milestones; and |
|
|
|
|
we will pay to Perrigo royalty payments on sales of the novel proprietary
product. |
The $3.0 million payment will be recognized as research and development expense during
the three months ended June 30, 2009.
FDA Approval of DYSPORTTM
On April 29, 2009, the FDA approved the Biologics License Application for
DYSPORTTM, an acetylcholine release inhibitor and a neuromuscular blocking agent.
The approval includes two separate indications, the treatment of cervical dystonia in
adults to reduce the severity of abnormal head position and neck pain, and the temporary
improvement in the appearance of moderate to severe glabellar lines in adults younger than
65 years of age. RELOXIN®, which was the proposed U.S. name for Ipsens
botulinum toxin product for aesthetic use, will be marketed under the name of
DYSPORTTM. Ipsen will market
DYSPORTTM in the U.S. for the therapeutic indication (cervical dystonia),
while Medicis will market DYSPORTTM in the U.S. for the aesthetic indication
(glabellar lines).
32
In March 2006, Ipsen granted us the rights to develop, distribute and commercialize
Ipsens botulinum toxin product for aesthetic use in the U.S., Canada and Japan. In
accordance with the agreement, we will pay Ipsen $75.0 million during the second quarter of
2009 as a result of the approval by the FDA. The $75.0 million payment will be capitalized
into intangible assets in our consolidated balance sheet. We will pay Ipsen a royalty based
on sales and a supply price, the total of which is equivalent to approximately 30% of net
sales as defined under the agreement.
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, |
|
|
2009 (a) |
|
2008 (b) |
|
|
|
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (c) |
|
|
90.5 |
|
|
|
91.4 |
|
Operating expenses |
|
|
91.0 |
|
|
|
68.3 |
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(0.5 |
) |
|
|
23.1 |
|
Other expense, net |
|
|
(2.9 |
) |
|
|
(2.2 |
) |
Interest and investment income, net |
|
|
1.5 |
|
|
|
5.3 |
|
|
|
|
|
|
|
|
|
|
(Loss) income before income tax expense |
|
|
(1.9 |
) |
|
|
26.2 |
|
Income tax benefit (expense) |
|
|
2.2 |
|
|
|
(10.3 |
) |
|
|
|
|
|
|
|
|
|
Net income |
|
|
0.3 |
% |
|
|
15.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $3.9 million (3.9% of net revenues) of
compensation expense related to stock options and restricted stock. |
|
(b) |
|
Included in operating expenses is $4.4 million (3.4% of net revenues) of
compensation expense related to stock options and restricted stock. |
|
(c) |
|
Gross profit does not include amortization of the related intangibles as such
expense is included in operating expenses. |
33
Three Months Ended March 31, 2009 Compared to the Three Months Ended March 31, 2008
Net Revenues
The following table sets forth our net revenues for the three months ended March 31,
2009 (the first quarter of 2009) and March 31, 2008 (the first quarter of 2008), 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 |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
96.6 |
|
|
$ |
125.1 |
|
|
$ |
(28 5 |
) |
|
|
(22.8 |
)% |
Net contract revenues |
|
|
3.2 |
|
|
|
3.8 |
|
|
|
(0.6 |
) |
|
|
(16.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
99.8 |
|
|
$ |
128.9 |
|
|
$ |
(29.1 |
) |
|
|
(22.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne and acne-related
dermatological products |
|
$ |
66.4 |
|
|
$ |
80.1 |
|
|
$ |
(13.7 |
) |
|
|
(17.1 |
)% |
Non-acne dermatological
products |
|
|
23.5 |
|
|
|
39.1 |
|
|
|
(15.6 |
) |
|
|
(40.0 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
9.9 |
|
|
|
9.7 |
|
|
|
0.2 |
|
|
|
2.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
99.8 |
|
|
$ |
128.9 |
|
|
$ |
(29.1 |
) |
|
|
(22.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
|
|
2009 |
|
2008 |
|
Change |
Acne and acne-related
dermatological products |
|
|
66.6 |
% |
|
|
62.2 |
% |
|
|
4.4 |
% |
Non-acne dermatological
products |
|
|
23.5 |
% |
|
|
30.3 |
% |
|
|
(6.8 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
9.9 |
% |
|
|
7.5 |
% |
|
|
2.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues associated with our acne and acne-related dermatological products
decreased by $13.7 million, or 17.1%, during the first quarter of 2009 as compared to the
first quarter of 2008 primarily as a result of the decreased sales of SOLODYN®
due to the impact of the one-day launch of Tevas generic SOLODYN® product, which
caused wholesalers to reduce ordering levels of SOLODYN® and caused us to
increase our reserves for sales returns and consumer rebates. We expect net revenues of
SOLODYN® to continue to be negatively affected during the remainder of 2009 as
units of Tevas generic SOLODYN® product that were sold prior to the consummation
of a Settlement Agreement with us on March 18, 2009 are sold and prescribed through the
distribution channel. Net revenues associated with our non-acne dermatological products
decreased as a percentage of net revenues, and decreased in net dollars by $15.6 million, or
40.0%, during the first quarter of 2009 as compared to the first quarter of 2008. Beginning
in the second quarter of 2009, we will recognize revenue on our aesthetics products,
including RESTYLANE®, PERLANE® and DYSPORTTM, upon the
shipment from our exclusive distributor 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 $0.2 million, or 2.2%, and increased by 2.4 percentage points as a percentage
of net revenues during the first quarter of 2009 as compared to the first quarter of 2008.
34
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 2009 and 2008 was approximately $5.4
million and $5.3 million, respectively. 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 2009 and 2008,
along with the percentage of net revenues represented by such gross profit (dollar amounts
in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
90.4 |
|
|
$ |
117.8 |
|
|
$ |
(27.4 |
) |
|
|
(23.3 |
)% |
% of net revenues |
|
|
90.5 |
% |
|
|
91.4 |
% |
|
|
|
|
|
|
|
|
The decrease in gross profit during the first quarter of 2009, compared to the first
quarter of 2008, was due to the decrease in our net revenues, and the decrease in gross
profit as a percentage of net revenues was primarily due to the different mix of products
sold during the first quarter of 2009 as compared to the first quarter of 2008. Decreased
sales of SOLODYN®, a higher margin product, during the first quarter of 2009, was
the primary change in the mix of products sold during the comparable periods that affected
gross profit as a percentage of net revenues.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the
first quarter of 2009 and 2008, along with the percentage of net revenues represented by
selling, general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
70.4 |
|
|
$ |
72.1 |
|
|
$ |
(1.7 |
) |
|
|
(2.3 |
)% |
% of net revenues |
|
|
70.6 |
% |
|
|
55.9 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
3.7 |
|
|
$ |
4.3 |
|
|
$ |
(0.6 |
) |
|
|
(13.8 |
)% |
The decrease in selling, general and administrative expenses during the first quarter
of 2009 from the first quarter of 2008 was attributable to approximately $2.4 million of
decreased professional and consulting expenses and a net reduction of $1.4 million of other
selling, general and administrative costs incurred during the first quarter of 2009,
partially offset by $2.1 million of increased personnel costs, primarily related to an
increase in the number of employees from 496 as of March 31, 2008 to 613 as of March 31,
2009 and the effect of the annual salary increase that occurred during February 2009.
Professional and consulting expenses incurred during the first quarter of 2008 included
costs related to the implementation of our new enterprise resource planning (ERP) system.
The increase of selling, general and administrative expenses as a percentage of net revenues
during the first quarter of 2009 as compared to the first quarter of 2008 was primarily due
to the $29.1 million decrease in net revenues.
35
Research and Development Expenses
The following table sets forth our research and development expenses for the first
quarter of 2009 and 2008 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
|
|
|
|
2009 |
|
2008 |
|
$Change |
|
% Change |
Research and development |
|
$ |
13.3 |
|
|
$ |
9.2 |
|
|
$ |
4.1 |
|
|
|
44.5 |
% |
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 payment to IMPAX for the achievement of a clinical milestone. The primary product
under development during the first quarter of 2009 and 2008 was DYSPORTTM, which
was formerly known as RELOXIN® during clinical development. 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 2009 increased $0.4
million, or 6.1%, to $7.1 million from $6.7 million during the first quarter of 2008. This
increase was primarily due to depreciation incurred related to our new headquarters
facility.
Other Expense, net
Other expense, net, of $2.9 million recognized during the first quarter of 2009
primarily represented a $2.9 million 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. Other
expense, net, of $2.9 million recognized during the first quarter of 2008 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, 2008.
Interest and Investment Income
Interest and investment income during the first quarter of 2009 decreased $6.7 million,
or 73.0%, to $2.5 million from $9.2 million during the first quarter of 2008, due to an
decrease in the funds available for investment due to the repurchase of $283.7 million of
our New Notes in June 2008 and our $150.0 million acquisition of LipoSonix in July 2008, and
a decrease in the interest rates achieved by our invested funds during the first quarter of
2009. We expect interest and investment income to be lower in the first half of 2009 as
compared to the first half of 2008 due to the decrease in funds available for investment due
to the repurchase of $283.7 million of our New Notes in June 2008 and our $150.0 million
acquisition of LipoSonix in July 2008.
Interest Expense
Interest expense during the first quarter of 2009 decreased $1.3 million, to $1.1
million during the first quarter of 2009 from $2.4 million during the first quarter of 2008.
Our interest expense during the first quarter of 2009 and 2008 consisted of interest
expense on our Old Notes, which accrue interest at 2.5% per annum, our New Notes, which
accrue interest at 1.5% per annum, and amortization of fees and other origination costs
related to the issuance of the New Notes. The decrease in interest expense during the first
quarter of 2009 as compared to the first quarter of 2008 was primarily due to the repurchase
of $283.7 million of our New Notes in June 2008, and the fees and origination costs related
to the issuance of the New Notes becoming fully amortized during the second quarter of 2008.
See Note 10 in our accompanying condensed
consolidated financial
36
statements for further discussion on the Old Notes and New
Notes. We expect interest expense to be lower in the first half of 2009 as compared to the
first half of 2008 due to the impact of the repurchase of $283.7 million of our New Notes in
June 2008 and the impact of the origination costs of the New Notes being fully amortized as
of June 30, 2008.
Income Tax Expense
Our effective tax rate for the first quarter of 2009 was 117.3%, as compared to 39.1%
for the first quarter of 2008. 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%.
The 41.6% reflects managements estimate of the effective tax rate expected to be applicable
for the full year.
37
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the first quarter of
2009 and 2008, and selected balance sheet components as of March 31, 2009 and December 31,
2008 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
First Quarter |
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
45.4 |
|
|
$ |
33.1 |
|
|
$ |
12.3 |
|
|
|
37.2 |
% |
Investing activities |
|
|
9.2 |
|
|
|
61.5 |
|
|
|
(52.3 |
) |
|
|
(85.0 |
)% |
Financing activities |
|
|
(2.3 |
) |
|
|
(0.9 |
) |
|
|
(1.4 |
) |
|
|
(148.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mar. 31, 2009 |
|
Dec. 31, 2008 |
|
$ Change |
|
% Change |
Cash, cash equivalents,
and short-term investments |
|
$ |
399.4 |
|
|
$ |
343.9 |
|
|
$ |
55.5 |
|
|
|
16.1 |
% |
Working capital |
|
|
332.1 |
|
|
|
307.6 |
|
|
|
24.5 |
|
|
|
8.0 |
% |
Long-term investments |
|
|
40.4 |
|
|
|
55.3 |
|
|
|
(14.9 |
) |
|
|
(27.0 |
)% |
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, 2009 and December 31, 2008 consisted of the following
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mar. 31, 2009 |
|
|
Dec. 31, 2008 |
|
|
$Change |
|
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
399.4 |
|
|
$ |
343.9 |
|
|
$ |
55.5 |
|
|
|
16.1 |
% |
Accounts receivable, net |
|
|
50.9 |
|
|
|
52.6 |
|
|
|
(1.7 |
) |
|
|
(3.2 |
)% |
Inventories, net |
|
|
25.4 |
|
|
|
24.2 |
|
|
|
1.2 |
|
|
|
4.6 |
% |
Deferred tax assets, net |
|
|
66.1 |
|
|
|
53.2 |
|
|
|
12.9 |
|
|
|
24.4 |
% |
Other current assets |
|
|
20.8 |
|
|
|
19.6 |
|
|
|
1.2 |
|
|
|
6.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
562.6 |
|
|
|
493.5 |
|
|
|
69.1 |
|
|
|
14.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
43.8 |
|
|
|
39.0 |
|
|
|
4.8 |
|
|
|
12.1 |
% |
Reserve for sales returns |
|
|
68.4 |
|
|
|
59.6 |
|
|
|
8.8 |
|
|
|
14.8 |
% |
Income taxes payable |
|
|
4.4 |
|
|
|
|
|
|
|
4.4 |
|
|
|
100.0 |
% |
Other current liabilities |
|
|
113.9 |
|
|
|
87.3 |
|
|
|
26.6 |
|
|
|
30.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
230.5 |
|
|
|
185.9 |
|
|
|
44.6 |
|
|
|
24.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
332.1 |
|
|
$ |
307.6 |
|
|
$ |
24.5 |
|
|
|
8.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $399.4 million and working
capital of $332.1 million at March 31, 2009, as compared to $343.9 million and $307.6
million, respectively, at December 31, 2008. The increases were primarily due to the
generation of $45.4 million of operating cash flow during the first quarter of 2009.
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, including $75.0
million that we will pay to Ipsen during the second quarter of 2009 as a result of the FDAs
April 29, 2009 approval of DYSPORTTM (formerly known as RELOXIN®
during clinical development), strategic investments, acquisitions of companies or products
complementary
to our business, the repayment of outstanding indebtedness, repurchases of our outstanding
securities and
38
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 that
employs a staff of approximately 40 scientists, engineers and clinicians located near
Seattle, Washington. LipoSonix is a medical device company developing non-invasive body
sculpting technology, and its first product is being marketed and sold through distributors
in Europe. The LipoSonix technology is currently not approved for sale or use in the United
States. 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 LipoSonix
technology and if various commercial milestones are achieved on a worldwide basis.
As of December 31, 2008, our short-term investments included $38.2 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. As a result of the continued lack of liquidity
of these investments, we recorded an other-than-temporary impairment loss of $6.4 million
during the fourth quarter of 2008 on our auction rate floating securities, based on our
estimate of the fair value of these investments.
Operating Activities
Net cash provided by operating activities during the first quarter of 2009 was
approximately $45.4 million, compared to cash provided by operating activities of
approximately $33.1 million during the first quarter of 2008. The following is a summary
of the primary components of cash provided by operating activities during the first quarter
of 2009 and 2008 (in millions):
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
|
First Quarter |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Income taxes paid |
|
$ |
(1.5 |
) |
|
$ |
(11.3 |
) |
Payment made to IMPAX related to development agreement |
|
|
(5.0 |
) |
|
|
|
|
Other cash provided by operating activities |
|
|
51.9 |
|
|
|
44.4 |
|
|
|
|
|
|
|
|
Cash provided by operating activities |
|
$ |
45.4 |
|
|
$ |
33.1 |
|
|
|
|
|
|
|
|
39
Investing Activities
Net cash provided by investing activities during the first quarter of 2009 was
approximately $9.2 million, compared to net cash provided by investing activities during the
first quarter of 2008 of $61.5 million. The change was primarily due to the net purchases
and sales of our short-term and long-term investments during the respective quarters.
Financing Activities
Net cash used in financing activities during the first quarter of 2009 was $2.3
million, compared to net cash used in financing activities of $0.9 million during the first
quarter of 2008. Dividends paid during the first quarter of 2009 were $2.3 million, and
dividends paid during the first quarter of 2008 were $1.7 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 $11.7 million of long-term
liabilities at March 31, 2009 and we had $230.5 million of current liabilities at March 31,
2009. 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.
We have made available to BioMarin the ability to draw down on a Convertible Note up to
$25.0 million beginning July 1, 2005 (the Convertible Note). The Convertible Note is
convertible based on certain terms and conditions including a change of control provision.
Money advanced under the Convertible Note is convertible into BioMarin shares at a strike
price equal to the BioMarin average closing price for the 20 trading days prior to such
advance. The Convertible Note matures on the option purchase date in 2009 as defined in the
securities purchase agreement entered into on May 18, 2004, but may be repaid by BioMarin at
any time prior to the option purchase date. As of May 11, 2009, BioMarin has not requested
any monies to be advanced under the Convertible Note, and no amounts are outstanding.
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 SFAS 146, a liability for the costs
associated with an exit or disposal activity is recognized when the liability is incurred.
In accordance with SFAS 146, 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. These amounts were recorded as selling,
general and administrative expenses in our condensed consolidated statements of operations.
We have not recorded any other costs related to the lease for the prior headquarters.
As of March 31, 2009, approximately $3.5 million of lease exit costs remain accrued and
are expected to be paid by December 2010 of which $1.9 million is classified in other
current liabilities and
$1.6 million is classified in other liabilities. Although we no longer use the
facilities, the lease exit cost
40
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, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2008 |
|
to Expense |
|
Made |
|
from Sublease |
|
March 31, 2009 |
Lease exit costs
liability |
|
$ |
3,996,102 |
|
|
$ |
65,737 |
|
|
$ |
(534,528 |
) |
|
$ |
|
|
|
$ |
3,527,311 |
|
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash
dividends aggregating approximately $39.5 million on our common stock. In addition, on
March 11, 2009, we declared a cash dividend of $0.04 per issued and outstanding share of
common stock payable on April 30, 2009 to our stockholders of record at the close of
business on April 1, 2009. 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 $38.6 million at March 31, 2009. These
securities were included in long-term investments at March 31, 2009. We also utilize
unobservable (Level 3) inputs to value our investment in Revance, which was $0 at March 31,
2009.
Our auction rate floating securities are classified as available for sale 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 SFAS No 157. However, due to events in credit markets
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 utilizing a
discounted cash flow analysis as of March 31, 2009. 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, and we recorded an other-than-temporary impairment
loss of $6.4 million during the fourth quarter of 2008 on our auction rate floating
securities, based on our estimate of the fair value of these investments. Our estimate of
fair value of our auction-rate floating securities was based on market information and
estimates determined by our management, which could change in the future based on market
conditions.
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, 2009 and December 31, 2008, 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 SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, 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.
41
Off-Balance Sheet Arrangements
As of March 31, 2009, 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, 2008. There were no
new significant accounting estimates in the first quarter of 2009, 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, 2008.
Recent Accounting Pronouncements
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, which replaces
SFAS No. 141 and establishes principles and requirements for how an acquirer in a business
combination recognizes and measures in its financial statements the identifiable assets
acquired, the liabilities assumed and any controlling interest. It also established
principles and requirements for how an acquirer in a business combination recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain
purchase, and determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business combination. SFAS
No. 141R provides for the following changes from SFAS No. 141: 1) an acquirer will record
all assets and liabilities of acquired business, including goodwill, at fair value,
regardless of the level of interest acquired; 2) certain contingent assets and liabilities
acquired will be recognized at fair value at the acquisition date; 3) contingent
consideration will be recognized at fair value on the acquisition date with changes in fair
value to be recognized in earnings; 4) acquisition-related transaction and restructuring
costs will be expensed as incurred rather than treated as part of the cost of the
acquisition and included in the amount recorded for assets acquired; 5) reversals of
valuation allowances related to acquired deferred tax assets and changes to acquired income
tax uncertainties will be recognized in earnings; and 6) when making adjustments to
finalize initial accounting, acquirers will revise any previously issued post-acquisition
financial information in future financial statements to reflect any adjustments as if they
occurred on the acquisition date. SFAS No. 141R applies prospectively to business
combinations we enter into, if any, for which the acquisition date is on or after January 1,
2009. We adopted SFAS No. 141R on January 1, 2009, and the impact of SFAS No. 141R, if any,
on our consolidated results of operations and financial condition will depend on the nature
of business combinations we enter into, if any, subsequent to January 1, 2009.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements an amendment of Accounting Research Bulletin No. 51.
SFAS No. 160 establishes new accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a subsidiary. Specifically, this
statement requires the recognition of a noncontrolling interest, or minority interest, as
equity in the consolidated financial statements and separate from the parents equity. The
amount of net income attributable to the noncontrolling interest will be included in
consolidated net income on the face of the statement of operations. SFAS No. 160 clarifies
that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains it controlling financial
interest. In addition, this statement requires that a parent recognize a gain or loss in
net income when a subsidiary is deconsolidated. Such gain or loss will be measured using
the fair value of the noncontrolling equity investment on the deconsolidation date. SFAS
No. 160 also includes expanded disclosure requirements regarding the interests of the parent and its
42
noncontrolling interest. SFAS No. 160 is effective for fiscal years beginning on or after
December 15, 2008. We adopted SFAS No. 160 on January 1, 2009, and it did not have a
material impact on our consolidated results of operations and financial condition.
In December 2007, the EITF reached a consensus on EITF 07-01, Accounting for
Collaborative Agreements. EITF 07-01 prohibits companies from applying the equity method of
accounting to activities performed outside a separate legal entity by a virtual joint
venture. Instead, revenues and costs incurred with third parties in connection with the
collaborative arrangement should be presented gross or net by the collaborators based on the
criteria in EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an
Agent, and other applicable accounting literature. The consensus should be applied to
collaborative arrangements in existence at the date of adoption using a modified
retrospective method that requires reclassification in all periods presented for those
arrangements still in effect at the transition date, unless that application is
impracticable. The consensus is effective for fiscal years beginning after December 15,
2008. We adopted EITF 07-01 on January 1, 2009, and it did not have a material impact on
our consolidated results of operations and financial condition.
In April 2008, the FASB issued FSP 142-3, Determination of the Useful Life of
Intangible Assets. FSP 142-3 amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful life of a recognized
intangible asset under SFAS No. 142, Goodwill and Other Intangible Assets. FSP 142-3 is
effective for fiscal years beginning after December 15, 2008. We adopted FSP 142-3 on
January 1, 2009, and it did not have a material impact on our consolidated results of
operations and financial condition.
In May 2008, the FASB issued FSP APB 14-1, Accounting for Convertible Debt Instruments
That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement). FSP APB
14-1 clarifies the accounting for convertible debt instruments that may be settled in cash
(including partial cash settlement) upon conversion. FSP APB 14-1 specifies that issuers of
such instruments should separately account for the liability and equity components of
certain convertible debt instruments in a manner that reflects the issuers nonconvertible
debt borrowing rate when interest cost is recognized. FSP APB 14-1 requires bifurcation of
a component of the debt, classification of that component in equity and the accretion of the
resulting discount on the debt to be recognized as part of interest expense. FSP APB 14-1
requires retrospective application to the terms of instruments as they existed for all
periods presented. FSP APB 14-1 is effective for fiscal years beginning after December 15,
2008, and early adoption is not permitted. We adopted FSP APB 14-1 on January 1, 2009, and
it did not have a material impact on our consolidated results of operations and financial
condition.
In June 2008, the FASB reached a consensus on EITF 07-5, Determining Whether an
Instrument (or Embedded Feature) Is Indexed to an Entitys Own Stock. EITF 07-5 addresses
the determination of whether an instrument (or embedded feature) is indexed to an entitys
own stock. EITF 07-5 is effective for fiscal years beginning after December 15, 2008. We
adopted EITF 07-5 on January 1, 2009, and it did not have a material impact on our
consolidated results of operations and financial condition.
In June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted
in Share-Based Payment Transactions Are Participating Securities. In FSP 03-6-1, unvested
share-based payment awards that contain rights to receive nonforfeitable dividends or
dividend equivalents (whether paid or unpaid) are participating securities, and thus, should
be 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 shareholders. We adopted FASB
Staff Position No. EITF 03-6-1 on January 1, 2009, and it did not have a material impact on
our disclosure of earnings per share.
In April 2009, the FASB issued FSP FAS No. 115-2 and FAS No. 124-2, Recognition and
Presentation of Other-Than-Temporary Impairments, which amends SFAS No. 115 and FSP FAS No.
115-1 and FSP FAS No. 124-1, and improves the presentation and disclosure of
other-than-temporary impairments on debt and equity securities in the financial statements.
FSP FAS No. 115-2 and FAS No. 124-2 are effective for interim and annual reporting periods
ending after June 15, 2009. We do not expect the adoption of FSP FAS No. 115-2 and FAS No. 124-2 to have a material impact on our
consolidated results of operations and financial condition.
43
In April 2009, the FASB issued FSP FAS No. 157-4, Determining Fair Value When the
Volume and Level of Activity for the Asset or Liability Have Significantly Decreased and
Identifying Transactions That Are Not Orderly, which provides additional guidance for
estimating fair value in accordance with SFAS No. 157, Fair Value Measurements, when the
volume and level of activity for the asset or liability have significantly decreased. This
FSP also includes guidance on identifying circumstances that indicate a transaction is not
orderly and applies to all assets and liabilities within the scope of accounting
pronouncements that require or permit fair value measurements, except in paragraphs 2 and 3
of SFAS No. 157. FSP FAS No. 157-4 is effective for interim and annual reporting periods
ending after June 15, 2009. We do not expect the adoption of FSP FAS No. 157-4 to have a
material impact on our consolidated results of operations and financial condition.
In April 2009, the FASB issued FSP FAS No. 107-1 and APB No. 28-1, Interim Disclosures
about Fair Value of Financial Instruments, which amends the disclosure requirements of SFAS
No. 107 and APB No. 28 and requires disclosure about the fair value of its financial
instruments whenever it issues summarized financial information for interim reporting
periods. FSP FAS No. 107-1 and APB Opinion No. 28-1 are effective for financial statements
issued for interim reporting periods ending after June 15, 2009. We do not expect the
adoption of FSP FAS No. 107-1 and APB Opinion No. 28-1 to have a material impact on our
consolidated results of operations and financial condition.
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 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:
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competitive developments affecting our products, such as the recent FDA approvals of
Evolence®, Prevelle® Silk, Radiesse®,
Sculptra®, Elevess, 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 and LOPROX® Cream and LOPROX®
Gel products, and potential generic forms of our LOPROX® Shampoo,
TRIAZ®, PLEXION®, SOLODYN® or VANOS®
products; |
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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; |
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the success of research and development activities, including the development of
additional forms of SOLODYN®, and our ability to obtain regulatory
approvals; |
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the speed with which regulatory authorizations and product launches may be achieved; |
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changes in the FDAs position on the safety or effectiveness of our products; |
44
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changes in our product mix; |
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the anticipated size of the markets and demand for our products; |
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changes in prescription levels; |
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the impact of acquisitions, divestitures and other significant corporate
transactions, including our acquisition of LipoSonix; |
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the effect of economic changes generally and in hurricane-effected areas; |
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manufacturing or supply interruptions; |
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importation of other dermal filler products, including the unauthorized distribution
of products approved in countries neighboring the U.S.; |
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changes in the prescribing or procedural practices of dermatologists, podiatrists
and/or plastic surgeons, including prescription levels; |
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the ability to successfully market both new and existing products; |
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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; |
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the availability of product supply or changes in the cost of raw materials; |
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the ability to compete against generic and other branded products; |
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trends toward managed care and health care cost containment; |
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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®; |
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possible federal and/or state legislation or regulatory action affecting, among
other things, pharmaceutical pricing and reimbursement, including Medicaid and Medicare
and involuntary approval of prescription medicines for over-the-counter use; |
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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); |
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changes in U.S. generally accepted accounting principles; |
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additional costs related to compliance with changing regulation of corporate
governance and public financial disclosure; |
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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; |
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access to available and feasible financing on a timely basis; |
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the availability of product acquisition or in-licensing opportunities; |
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the risks and uncertainties normally incident to the pharmaceutical and medical
device industries, including product liability claims; |
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the risks and uncertainties associated with obtaining necessary FDA approvals; |
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the inability to obtain required regulatory approvals for any of our pipeline
products; |
45
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unexpected costs and expenses, or our ability to limit costs and expenses as our
business continues to grow; |
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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; |
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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 |
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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, 2008 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, 2009, 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,
2008.
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, 2009 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, 2009, 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.
46
Part II. Other Information
Item 1. Legal Proceedings
The following supplements and amends the discussion set forth under Part I, Item 3,
Legal Proceedings in our Annual Report on Form 10-K for the year ended December 31, 2008.
On January 13, 2009, we filed suit against Mylan, Inc., Matrix Laboratories Ltd.,
Matrix Laboratories Inc., Sandoz, Inc., and Barr Laboratories, Inc. (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 our U.S. Patent No. 5,908,838 (the 838 patent) by
submitting to the FDA their respective ANDAs for generic versions of SOLODYN®.
The relief we requested includes a request for a permanent injunction preventing Defendants
from infringing the 838 patent by selling generic versions of SOLODYN®. On
March 18, 2009, we entered into a Settlement Agreement with Barr (a subsidiary of Teva)
whereby all legal disputes between us and Teva relating to SOLODYN® were
terminated and where Barr/Teva agreed that our 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 Matrix Laboratories Inc. and us without prejudice, pursuant
to a stipulation between Medicis and Matrix Laboratories Inc.
On January 21, 2009, we received a letter from a stockholder demanding that our Board
of Directors take certain actions, including potentially legal action, in connection with
the restatement of our consolidated financial statements in 2008. Our Board of Directors is
reviewing the letter and has 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 does 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
us and our 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 any other appropriate action to be taken. The ultimate outcome of
these potential actions could have a material adverse effect on our business, financial
condition, cash flows and the trading price for our securities.
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 our securities during the period between
October 30, 2003 and approximately September 24, 2008. The complaints name as defendants
Medicis Pharmaceutical Corp. and our Chief Executive Officer and Chairman of the Board,
Jonah Shacknai, our Chief Financial Officer, Executive Vice President and Treasurer, Richard
D. Peterson, and our Chief Operating Officer and Executive Vice President, Mark A. Prygocki.
Plaintiffs claims arise in connection with the restatement of our annual, transition, and
quarterly periods in fiscal years 2003 through 2007 and the first and second quarters of
2008. The complaints allege violations of federal securities laws, Sections 10(b) and 20(a)
of the Securities Exchange Act of 1934 and Rule 10b-5, based on alleged material
misrepresentations to the market that had the effect of artificially inflating the market
price of our stock. The plaintiffs seek to recover unspecified damages and costs, including
counsel and expert fees. The Court has consolidated these actions into a single proceeding,
appointed a lead plaintiff and lead plaintiffs counsel, and ordered the lead plaintiff to
file a single, consolidated complaint by May 18, 2009. We intend to vigorously defend the
claims in these consolidated matters. There can be no assurance, however, that we will be
successful, and an adverse resolution of the lawsuits could have a material adverse effect
on our financial position and results of operations in the period in which the lawsuits are
resolved. We are not presently able to reasonably estimate potential losses, if any,
related to the lawsuits.
On April 30, 2008, we received notice from Perrigo Israel Pharmaceuticals Ltd.
(Perrigo Israel), a generic pharmaceutical company, that it had filed an ANDA with the FDA
for a generic version of our VANOS® fluocinonide cream 0.1%. Perrigo Israels
notice indicated that it was challenging only one of
47
the two patents that we listed with the FDA for VANOS® Cream. On June 6, 2008,
we filed a complaint for patent infringement against Perrigo Israel and its domestic
corporate parent Perrigo Company in the United States District Court for the Western
District of Michigan, Civil Action No. 1:08-cv-0539-PLM. The complaint asserts that Perrigo
Israel and Perrigo Company have infringed both of our patents for VANOS® Cream
(United States Patent Nos. 6,765,001 and 7,220,424). Perrigo Israel and Perrigo Company
filed a joint Answer on November 4, 2008. On April 8, 2009, Medicis, Perrigo Israel and
Perrigo Company agreed to terminate all legal disputes between them relating to our
VANOS® fluocinonide Cream. On April 18, 2009, the Court formally dismissed the
action.
On October 27, 2005, we filed suit against Upsher-Smith Laboratories, Inc. of Plymouth,
Minnesota and against Prasco Laboratories of Cincinnati, Ohio for infringement of Patent No.
6,905,675 entitled Sulfur Containing Dermatological Compositions and Methods for Reducing
Malodors in Dermatological Compositions covering our sodium sulfacetamide/sulfur
technology. This intellectual property is related to our PLEXION® Cleanser
product. The suit was filed in the U.S. District Court for the District of Arizona, and
seeks an award of damages, as well as a preliminary and a permanent injunction. A hearing
on our preliminary injunction motion was heard on March 8 and March 9, 2006. On May 2,
2006, an order denying the motion for a preliminary injunction was received by Medicis. The
Court has entered an order staying the case until the conclusion of a patent reexamination
request submitted by Medicis.
In addition to the matters discussed above, we and certain of our subsidiaries are
parties to other actions and proceedings incident to our business, including litigation
regarding our intellectual property, challenges to the enforceability or validity of our
intellectual property and claims that our products infringe on the intellectual property
rights of others. We record contingent liabilities resulting from claims against us when it
is probable (as that word is defined in Statement of Financial Accounting Standards No. 5)
that a liability has been incurred and the amount of the loss is reasonably estimable. We
disclose material contingent liabilities when there is a reasonable possibility that the
ultimate loss will exceed the recorded liability. Estimating probable losses requires
analysis of multiple factors, in some cases including judgments about the potential actions
of third-party claimants and courts. Therefore, actual losses in any future period are
inherently uncertain. In all of the cases noted where we are the defendant, we believe we
have meritorious defenses to the claims in these actions and resolution of these matters
will not have a material adverse effect on our business, financial condition, or results of
operation; however, the results of the proceedings are uncertain, and there can be no
assurance to that effect.
Item 1A. Risk Factors
We operate in a rapidly changing environment that involves a number of risks. The
following discussion highlights some of these risks and others are discussed elsewhere in
this report. These and other risks 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 fiscal year ended December 31, 2008.
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 fiscal year ended December
31, 2008.
Item 5. Other Information
During the first quarter of 2009, we executed and delivered to each of our directors
and officers an indemnification agreement approved by our Board of Directors. The agreement
confirms our obligations to indemnify the directors and officers to the fullest extent
authorized by applicable law and supplements the indemnification otherwise available to the
covered person under our charter and bylaws. The form of indemnification agreement is
attached hereto as Exhibit 10.5 and is incorporated herein by this reference. The
description above is qualified in its entirety by reference to such exhibit.
48
Item 6. Exhibits
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Exhibit 3.2
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Amended and Restated By-Laws of the Company (1) |
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Exhibit 10.1+
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Amendment No. 4 to the Medicis 2006 Incentive Award Plan, dated March 26, 2009. |
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Exhibit 10.2+*
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Settlement Agreement, dated March 18, 2009, between the Company and Barr
Laboratories, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA, Inc. |
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Exhibit 10.3+*
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License and Settlement Agreement, dated April 8, 2009, between the Company
and Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company. |
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Exhibit 10.4+*
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Joint Development Agreement, dated April 8, 2009, between the Company and
Perrigo Israel Pharmaceuticals Ltd. |
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Exhibit 10.5+
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Form of Indemnification Agreement for Directors and Officers of the Company. |
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Exhibit 31.1+
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Certification by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
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Exhibit 31.2+
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Certification by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
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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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+ |
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Filed herewith |
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* |
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Portions of this exhibit (indicated by asterisks) have been omitted pursuant to
a request for confidential treatment pursuant to Rule 24b-2 under the Securities
Exchange Act of 1934. |
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(1) |
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Incorporated by reference to the Companys Current Report on Form 8-K filed
with the SEC on February 19, 2009. |
49
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 11, 2009 |
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 11, 2009 |
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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50