e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2010
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission
file number: 001-14471
MEDICIS PHARMACEUTICAL CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware
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52-1574808 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
7720 North Dobson Road
Scottsdale, Arizona 85256-2740
(Address of principal executive offices)
(602) 808-8800
(Registrants telephone number,
including area code)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(do not check if a smaller
reporting company) |
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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 August 4, 2010 |
Class A Common Stock $.014 Par Value |
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60,171,937 (a) |
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(a) includes 1,814,237 shares of unvested restricted stock awards |
MEDICIS PHARMACEUTICAL CORPORATION
Table of Contents
Part I. Financial Information
Item 1. Financial Statements
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
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June 30, 2010 |
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December 31, 2009 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
98,308 |
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$ |
209,051 |
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Short-term investments |
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445,209 |
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319,229 |
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Accounts receivable, net |
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136,899 |
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95,222 |
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Inventories, net |
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37,251 |
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25,985 |
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Deferred tax assets, net |
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67,261 |
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66,321 |
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Other current assets |
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20,418 |
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16,525 |
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Total current assets |
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805,346 |
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732,333 |
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Property and equipment, net |
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26,281 |
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25,247 |
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Net intangible assets |
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216,245 |
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227,840 |
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Goodwill |
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93,282 |
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93,282 |
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Deferred tax assets, net |
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52,818 |
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64,947 |
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Long-term investments |
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60,996 |
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25,524 |
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Other assets |
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3,025 |
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3,025 |
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$ |
1,257,993 |
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$ |
1,172,198 |
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See accompanying notes to condensed consolidated financial statements.
1
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
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June 30, 2010 |
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December 31, 2009 |
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(unaudited) |
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Liabilities |
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Current liabilities: |
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Accounts payable |
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$ |
58,574 |
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$ |
44,183 |
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Reserve for sales returns |
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49,194 |
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48,062 |
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Accrued consumer rebates and loyalty programs |
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90,364 |
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73,311 |
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Managed care and Medicaid reserves |
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44,410 |
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47,078 |
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Income taxes payable |
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2,756 |
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16,679 |
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Other current liabilities |
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71,466 |
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68,381 |
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Total current liabilities |
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316,764 |
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297,694 |
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Long-term liabilities: |
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Contingent convertible senior notes |
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169,326 |
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169,326 |
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Other liabilities |
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7,961 |
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9,919 |
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Stockholders Equity |
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Preferred stock, $0.01 par value; shares
authorized: 5,000,000; issued and outstanding: none |
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Class A common stock, $0.014 par value;
shares authorized: 150,000,000; issued and
outstanding: 71,204,269 and 70,732,409 at
June 30, 2010 and December 31, 2009,
respectively |
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986 |
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985 |
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Class B common stock, $0.014 par value; shares
authorized: 1,000,000; issued and outstanding: none |
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Additional paid-in capital |
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696,611 |
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690,497 |
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Accumulated other comprehensive loss |
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(2,813 |
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(3,814 |
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Accumulated earnings |
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416,504 |
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351,842 |
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Less: Treasury stock, 12,882,586 and 12,749,261 shares
at cost at June 30, 2010 and December 31,
2009, respectively |
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(347,346 |
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(344,251 |
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Total stockholders equity |
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763,942 |
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695,259 |
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$ |
1,257,993 |
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$ |
1,172,198 |
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See accompanying notes to condensed consolidated financial statements.
2
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share data)
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Three Months Ended |
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Six Months Ended |
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June 30, 2010 |
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June 30, 2009 |
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June 30, 2010 |
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June 30, 2009 |
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Net product revenues |
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$ |
172,183 |
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$ |
138,695 |
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$ |
336,723 |
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$ |
235,294 |
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Net contract revenues |
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1,862 |
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2,551 |
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3,812 |
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5,770 |
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Net revenues |
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174,045 |
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141,246 |
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340,535 |
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241,064 |
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Cost of product revenues (1) |
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16,527 |
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13,067 |
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32,283 |
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22,512 |
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Gross profit |
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157,518 |
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128,179 |
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308,252 |
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218,552 |
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Operating expenses: |
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Selling, general and administrative (2) |
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80,873 |
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71,654 |
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156,822 |
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142,079 |
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Research and development (3) |
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10,511 |
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12,072 |
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20,675 |
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25,347 |
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Depreciation and amortization |
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7,239 |
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7,945 |
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14,292 |
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15,077 |
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Operating income |
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58,895 |
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36,508 |
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116,463 |
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36,049 |
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Interest and investment income |
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(780 |
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(2,158 |
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(1,940 |
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(4,645 |
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Interest expense |
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1,061 |
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1,058 |
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2,119 |
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2,112 |
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Other (income) expense, net |
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(2 |
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(2,243 |
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257 |
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630 |
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Income before income tax expense |
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58,616 |
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39,851 |
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116,027 |
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37,952 |
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Income tax expense |
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22,117 |
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24,258 |
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44,158 |
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22,031 |
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Net income |
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$ |
36,499 |
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$ |
15,593 |
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$ |
71,869 |
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$ |
15,921 |
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Basic net income per share |
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$ |
0.61 |
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$ |
0.26 |
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$ |
1.19 |
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$ |
0.27 |
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Diluted net income per share |
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$ |
0.56 |
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$ |
0.25 |
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$ |
1.10 |
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$ |
0.27 |
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Cash dividend declared per common share |
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$ |
0.06 |
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$ |
0.04 |
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$ |
0.12 |
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$ |
0.08 |
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Common shares used in calculating: |
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Basic net income per share |
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58,271 |
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57,088 |
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58,161 |
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56,911 |
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Diluted net income per share |
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64,395 |
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63,008 |
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64,294 |
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62,838 |
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(1) amounts exclude amortization
of intangible assets related to
acquired products |
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$ |
5,351 |
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$ |
6,233 |
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$ |
10,703 |
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$ |
11,675 |
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(2) amounts include share-based
compensation expense |
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$ |
2,197 |
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$ |
4,786 |
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$ |
5,161 |
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$ |
8,519 |
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(3) amounts include share-based
compensation expense |
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$ |
92 |
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$ |
230 |
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$ |
223 |
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$ |
368 |
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See accompanying notes to condensed consolidated financial statements.
3
MEDICIS
PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Six Months Ended |
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June 30, 2010 |
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June 30, 2009 |
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Operating Activities: |
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Net income |
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$ |
71,869 |
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$ |
15,921 |
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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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14,292 |
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15,077 |
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Gain on sale of product rights |
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(350 |
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Gain on sale of Medicis Pediatrics |
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(2,915 |
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Adjustment of impairment of available-for-sale investments |
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260 |
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(33 |
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Charge reducing value of investment in Revance |
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2,886 |
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Loss (gain) on sale of available-for-sale investments, net |
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750 |
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(76 |
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Share-based compensation expense |
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5,384 |
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8,887 |
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Deferred income tax expense (benefit) |
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10,602 |
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(3,378 |
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Tax expense from exercise of stock options and
vesting of restricted stock awards |
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(269 |
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(694 |
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Excess tax benefits from share-based payment arrangements |
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(320 |
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(169 |
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Increase in provision for sales discounts and chargebacks |
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1,031 |
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1,120 |
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Accretion (amortization) of premium/(discount) on investments |
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1,811 |
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1,416 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(42,708 |
) |
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(45,941 |
) |
Inventories |
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(11,266 |
) |
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(259 |
) |
Other current assets |
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(3,893 |
) |
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(999 |
) |
Accounts payable |
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14,391 |
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5,738 |
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Reserve for sales returns |
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1,132 |
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(1,937 |
) |
Income taxes payable |
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(13,923 |
) |
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19,372 |
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Other current liabilities |
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11,955 |
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39,925 |
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Other liabilities |
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(1,958 |
) |
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(2,569 |
) |
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Net cash provided by operating activities |
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59,140 |
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51,022 |
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Investing Activities: |
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Purchase of property and equipment |
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(3,732 |
) |
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(2,828 |
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Payments for purchase of product rights |
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(74,932 |
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Proceeds from sale of product rights |
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350 |
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Proceeds from sale of Medicis Pediatrics |
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70,294 |
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Purchase of available-for-sale investments |
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(273,403 |
) |
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(154,187 |
) |
Sale of available-for-sale investments |
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41,238 |
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71,201 |
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Maturity of available-for-sale investments |
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69,515 |
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84,276 |
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Net cash used in investing activities |
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(166,382 |
) |
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(5,826 |
) |
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Financing Activities: |
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Payment of dividends |
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(5,993 |
) |
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(4,663 |
) |
Excess tax benefits from share-based payment arrangements |
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320 |
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169 |
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Proceeds from the exercise of stock options |
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2,206 |
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6,807 |
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Net cash (used in) provided by financing activities |
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(3,467 |
) |
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2,313 |
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Effect of exchange rate on cash and cash equivalents |
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(34 |
) |
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(177 |
) |
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Net (decrease) increase in cash and cash equivalents |
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(110,743 |
) |
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47,332 |
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Cash and cash equivalents at beginning of period |
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|
209,051 |
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86,450 |
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Cash and cash equivalents at end of period |
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$ |
98,308 |
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$ |
133,782 |
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|
See accompanying notes to condensed consolidated financial statements.
4
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2010
(unaudited)
1. NATURE OF BUSINESS
Medicis Pharmaceutical Corporation (Medicis or the Company) is a leading specialty
pharmaceutical company focusing primarily on the development and marketing of products in the
United States (U.S.) for the treatment of dermatological and aesthetic conditions. Medicis also
markets products in Canada for the treatment of dermatological and aesthetic conditions and began
commercial efforts in Europe with the Companys acquisition of LipoSonix, Inc. (LipoSonix) in
July 2008.
The Company offers a broad range of products addressing various conditions or aesthetic
improvements including facial wrinkles, glabellar lines, acne, fungal infections, rosacea,
hyperpigmentation, photoaging, psoriasis, seborrheic dermatitis and cosmesis (improvement in the
texture and appearance of skin). Medicis currently offers 16 branded products. Its primary brands
are DYSPORT®, PERLANE®, RESTYLANE®, SOLODYN®,
TRIAZ®, VANOS® and ZIANA®. Medicis entered the non-invasive body
contouring market with its acquisition of LipoSonix in July 2008.
The consolidated financial statements include the accounts of Medicis and its wholly owned
subsidiaries. The Company does not have any subsidiaries in which it does not own 100% of the
outstanding stock. All of the Companys subsidiaries are included in the consolidated financial
statements. All significant intercompany accounts and transactions have been eliminated in
consolidation.
The accompanying interim condensed consolidated financial statements of Medicis have been
prepared in conformity with U.S. generally accepted accounting principles, consistent in all
material respects with those applied in the Companys Annual Report on Form 10-K for the year ended
December 31, 2009. The financial information is unaudited, but reflects all adjustments,
consisting only of normal recurring adjustments and accruals, which are, in the opinion of the
Companys management, necessary to a fair statement of the results for the interim periods
presented. Interim results are not necessarily indicative of results for a full year. The
information included in this Form 10-Q should be read in conjunction with the Companys Annual
Report on Form 10-K for the year ended December 31, 2009.
2. SHARE-BASED COMPENSATION
Stock Option and Restricted Stock Awards
At June 30, 2010, the Company had seven active share-based employee compensation plans. Of
these seven share-based compensation plans, only the 2006 Incentive Award Plan is eligible for the
granting of future awards. Stock option awards granted from these plans are granted at the fair
market value on the date of grant. The option awards vest over a period determined at the time the
options are granted, ranging from one to five years, and generally have a maximum term of ten
years. Certain options provide for accelerated vesting if there is a change in control (as defined
in the plans). When options are exercised, new shares of the Companys Class A common stock are
issued.
The total value of the stock option awards is expensed ratably over the service period of the
employees receiving the awards. As of June 30, 2010, total unrecognized compensation cost related
to stock option awards, to be recognized as expense subsequent to June 30, 2010, was approximately
$1.7 million and the related weighted average period over which it is expected to be recognized is
approximately 2.3 years.
5
A summary of stock option activity within the Companys stock-based compensation plans
and changes for the six months ended June 30, 2010, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
|
Balance at December 31, 2009 |
|
|
9,253,847 |
|
|
$ |
29.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
153,295 |
|
|
$ |
23.33 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(121,247 |
) |
|
$ |
18.39 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(361,446 |
) |
|
$ |
29.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
|
8,924,449 |
|
|
$ |
29.26 |
|
|
|
2.6 |
|
|
$ |
3,978,873 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during the six months ended June 30, 2010, was
$733,008. Options exercisable under the Companys share-based compensation plans at June 30, 2010,
were 8,603,970, with a weighted average exercise price of $29.44, a weighted average remaining
contractual term of 2.4 years, and an aggregate intrinsic value of $3,397,299.
A summary of outstanding and exercisable stock options that are fully vested and are expected
to vest, based on historical forfeiture rates, as of June 30, 2010, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
|
Outstanding, net of expected forfeitures |
|
|
8,167,720 |
|
|
$ |
29.37 |
|
|
|
2.6 |
|
|
$ |
3,488,183 |
|
Exercisable, net of expected forfeitures |
|
|
7,891,666 |
|
|
$ |
29.53 |
|
|
|
2.5 |
|
|
$ |
3,058,463 |
|
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:
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, 2010 |
|
June 30, 2009 |
|
Expected dividend yield |
|
1.02% to 1.06% |
|
0.34% to 1.01% |
Expected stock price volatility |
|
0.33 |
|
0.45 to 0.46 |
Risk-free interest rate |
|
2.82% to 3.04% |
|
2.18% to 2.76% |
Expected life of options |
|
7.0 Years |
|
7.0 Years |
The expected dividend yield is based on expected annual dividends to be paid by the Company as
a percentage of the market value of the Companys stock as of the date of grant. The Company
determined that a blend of implied volatility and historical volatility is more reflective of
market conditions and a better indicator of expected volatility than using purely historical
volatility. The risk-free interest rate is based on the U.S. treasury security rate in effect as
of the date of grant. The expected lives of options are based on historical data of the Company.
The weighted average fair value of stock options granted during the six months ended June 30,
2010 and 2009, was $8.28 and $6.44, respectively.
6
The Company also grants restricted stock awards to certain employees. Restricted stock awards
are valued at the closing market value of the Companys Class A common stock on the date of grant,
and the total value of the award is expensed ratably over the service period of the employees
receiving the grants. During the six months ended June 30, 2010, 511,235 shares of restricted
stock were granted to certain employees. Share-based compensation expense related to all
restricted stock awards outstanding during the three months ended June 30, 2010 and 2009, was
approximately $1.4 million and $2.3 million, respectively. Share-based compensation expense
related to all restricted stock awards outstanding during the six months ended June 30, 2010 and
2009, was approximately $3.3 million and $4.1 million, respectively. As of June 30, 2010, the
total amount of unrecognized compensation cost related to nonvested restricted stock awards, to be
recognized as expense subsequent to June 30, 2010, was approximately $29.9 million, and the related
weighted average period over which it is expected to be recognized is approximately 3.1 years.
A summary of restricted stock activity within the Companys share-based compensation plans and
changes for the six months ended June 30, 2010, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant-Date |
Nonvested Shares |
|
Shares |
|
Fair Value |
|
Nonvested at December 31, 2009 |
|
|
1,915,469 |
|
|
$ |
17.12 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
511,235 |
|
|
$ |
22.69 |
|
Vested |
|
|
(352,736 |
) |
|
$ |
18.57 |
|
Forfeited |
|
|
(223,941 |
) |
|
$ |
18.91 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2010 |
|
|
1,850,027 |
|
|
$ |
18.17 |
|
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the six months ended June 30, 2010 and
2009, was approximately $6.6 million and $3.7 million, respectively.
Stock Appreciation Rights
During 2009, the Company began granting cash-settled stock appreciation rights (SARs) to
many of its employees. SARs generally vest over a graduated five-year period and expire seven
years from the date of grant, unless such expiration occurs sooner due to the employees
termination of employment, as provided in the applicable SAR award agreement. SARs allow the
holder to receive cash (less applicable tax withholding) upon the holders exercise, equal to the
excess, if any, of the market price of the Companys Class A common stock on the exercise date over
the exercise price, multiplied by the number of shares relating to the SAR with respect to which
the SAR is exercised. The exercise price of the SAR is the fair market value of a share of the
Companys Class A common stock relating to the SAR on the date of grant. The total value of the
SARs is expensed over the service period of the employees receiving the grants, and a liability is
recognized in the Companys condensed consolidated balance sheets until settled. The fair value of
SARs is required to be remeasured at the end of each reporting period until the award is settled,
and changes in fair value must be recognized as compensation expense to the extent of vesting each
reporting period based on the new fair value. Share-based compensation expense related to SARs
during the three months ended June 30, 2010 and 2009, was approximately $0.5 million and $0.9
million, respectively. Share-based compensation expense related to SARs during the six months
ended June 30, 2010 and 2009, was approximately $1.2 million and $1.1 million, respectively. As of
June 30, 2010, the total measured amount of unrecognized compensation cost related to outstanding
SARs, to be recognized as expense subsequent to June 30, 2010, was approximately $23.6 million, and
the related weighted average period over which it is expected to be recognized is approximately 4.1
years.
7
The fair value of each SAR was estimated on the date of the grant, and was remeasured at
quarter-end, using the Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
SARs Granted During |
|
SARs Granted During |
|
|
|
|
the |
|
the |
|
Remeasurement |
|
|
Six Months Ended |
|
Six Months Ended |
|
as of |
|
|
June 30, 2010 |
|
June 30, 2009 |
|
June 30, 2010 |
|
Expected dividend yield
|
|
0.95% to 1.06%
|
|
0.35% to 1.01%
|
|
|
1.10 |
% |
Expected stock price volatility
|
|
0.32 to 0.33
|
|
0.45 to 0.46
|
|
|
0.34 |
|
Risk-free interest rate
|
|
3.04% to 3.07%
|
|
2.18% to 2.76%
|
|
|
2.42 |
% |
Expected life of SARs
|
|
7.0 Years
|
|
7.0 Years
|
|
5.7 to 6.8 Years
|
The weighted average fair value of SARs granted during the six months ended June 30, 2010
and 2009, as of the respective grant dates, was $8.14 and $5.33, respectively. The weighted
average fair value of all SARs outstanding as of the remeasurement date of June 30, 2010 was $9.69.
A summary of SARs activity for the six months ended June 30, 2010, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of SARs |
|
Price |
|
Term |
|
Value |
|
Balance at December 31, 2009 |
|
|
1,916,156 |
|
|
$ |
11.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,401,769 |
|
|
$ |
22.82 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(72,328 |
) |
|
$ |
11.30 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(209,195 |
) |
|
$ |
12.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
|
3,036,402 |
|
|
$ |
16.58 |
|
|
|
6.1 |
|
|
$ |
17,374,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of SARs exercised during the six months ended June 30, 2010, was $928,011.
As of June 30, 2010, 111,566 SARs were exercisable, with a weighted average exercise price of
$11.29, a weighted average remaining contractual term of 5.7 years, and an aggregate intrinsic
value of $1,181,363.
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 June 30, 2010, the Company has recorded the estimated fair value of available-for-sale and
trading securities in short-term and long-term investments of approximately $445.2 million and
$61.0 million, respectively. At June 30, 2010, $1.3 million of the Companys investments were
classified as trading securities.
8
Available-for-sale and trading securities consist of the following at June 30, 2010 (amounts
in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other-Than- |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Temporary |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Impairment |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Losses |
|
|
Value |
|
|
Corporate notes and bonds |
|
$ |
125,343 |
|
|
$ |
427 |
|
|
$ |
(248 |
) |
|
$ |
|
|
|
$ |
125,522 |
|
Federal agency notes and bonds |
|
|
354,966 |
|
|
|
1,033 |
|
|
|
(112 |
) |
|
|
|
|
|
|
355,887 |
|
Auction rate floating securities |
|
|
31,725 |
|
|
|
|
|
|
|
(7,550 |
) |
|
|
|
|
|
|
24,175 |
|
Asset-backed securities |
|
|
613 |
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
512,647 |
|
|
$ |
1,468 |
|
|
$ |
(7,910 |
) |
|
$ |
|
|
|
$ |
506,205 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three and six months ended June 30, 2010, no gross realized gains on sales of
available-for-sale securities were recognized. During the three and six months ended June 30,
2010, $0.5 million of gross realized losses were recognized. Gross unrealized gains and losses are
determined based on the specific identification method. The net adjustment to unrealized gains
during the three and six months ended June 30, 2010, on available-for-sale securities included in
stockholders equity totaled $0.6 million and $0.9 million, respectively. The amortized cost and
estimated fair value of the available-for-sale securities at June 30, 2010, by maturity, are shown
below (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
244,907 |
|
|
$ |
245,266 |
|
Due after one year through five years |
|
|
236,015 |
|
|
|
236,764 |
|
Due after 10 years |
|
|
30,425 |
|
|
|
22,875 |
|
|
|
|
|
|
|
|
|
|
$ |
511,347 |
|
|
$ |
504,905 |
|
|
|
|
|
|
|
|
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 June 30, 2010,
approximately $61.0 million in estimated fair value expected to mature greater than one year has
been classified as long-term investments since these investments are in an unrealized loss
position, and management has both the ability and intent to hold these investments until recovery
of fair value, which may be maturity.
As of June 30, 2010, the Companys investments included auction rate floating securities with
a fair value of $24.2 million. The Companys auction rate floating securities are debt instruments
with a long-term maturity and with an interest rate that is reset in short intervals through
auctions. The negative conditions in the credit markets during 2008, 2009 and the first half of
2010 have prevented some investors from liquidating their holdings, including their holdings of
auction rate floating securities. During the three months ended March 31, 2008, the Company was
informed that there was insufficient demand at auction for the auction rate floating securities.
As a result, these affected auction rate floating securities are now considered illiquid, and the
Company could be required to hold them until they are redeemed by the holder at maturity. The
Company may not be able to liquidate the securities until a future auction on these investments is
successful.
In November 2008, the Company entered into a settlement agreement with the broker through
which the Company purchased auction rate floating securities. The settlement agreement provides
the Company with the right to put an auction rate floating security currently held by the Company
back to the broker beginning on June 30, 2010. At
9
June 30, 2010 and December 31, 2009, the Company held one auction rate floating security with
a par value of $1.3 million that was subject to the settlement agreement. At inception, the
Company elected the irrevocable Fair Value Option treatment under ASC 825, Financial Instruments,
and accordingly adjusts the put option to fair value at each reporting date. Concurrent with the
execution of the settlement agreement, the Company reclassified this auction rate floating security
from available-for-sale to trading securities and accordingly, future changes in fair value related
to this investment and the related put option will be recorded in earnings. This auction rate
floating security was settled at par on July 1, 2010.
During the three months ended March 31, 2010, the Company became aware of new circumstances
that directly impacted the valuation of an asset-backed security that is owned by the Company. An
unrealized loss on the asset-backed security, based on the Companys intent to hold the security
until recovery of the fair value, had previously been recorded in stockholders equity. Based on
the new circumstances related to the investment, the Company determined that the impairment of the
asset-backed security was other-than-temporary, as the Company believed it would not recover its
investment even if the asset were held to maturity. A $0.3 million impairment charge was therefore
recorded in other expense, net, during the three months ended March 31, 2010 related to the
asset-backed security. The asset-backed security was sold in April 2010.
The following table shows the gross unrealized losses and the fair value of the Companys
investments, with unrealized losses that are not deemed to be other-than-temporarily impaired
aggregated by investment category and length of time that individual securities have been in a
continuous unrealized loss position at June 30, 2010 (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
|
Greater Than 12 Months |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
|
Corporate notes and bonds |
|
$ |
53,508 |
|
|
$ |
248 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and
bonds |
|
|
55,418 |
|
|
|
112 |
|
|
|
|
|
|
|
|
|
Auction rate floating
securities |
|
|
|
|
|
|
|
|
|
|
22,875 |
|
|
|
7,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
108,926 |
|
|
$ |
360 |
|
|
$ |
22,875 |
|
|
$ |
7,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2010, the Company has concluded that the unrealized losses on its investment
securities are temporary in nature and are caused by changes in credit spreads and liquidity issues
in the marketplace. Available-for-sale securities are reviewed quarterly for possible
other-than-temporary impairment. This review includes an analysis of the facts and circumstances
of each individual investment such as the severity of loss, the length of time the fair value has
been below cost, the expectation for that securitys performance and the creditworthiness of the
issuer. Additionally, the Company does not intend to sell and it is not more-likely-than-not that
the Company will be required to sell any of the securities before the recovery of their amortized
cost basis.
4. FAIR VALUE MEASUREMENTS
As of June 30, 2010, the Company held certain assets that are required to be measured at fair
value on a recurring basis. These included certain of the Companys short-term and long-term
investments, including investments in auction rate floating securities, and the Companys
investment in Hyperion Therapeutics, Inc. (Hyperion).
The Company has invested in auction rate floating securities, which are classified as
available-for-sale or trading securities and reflected at fair value. Due to events in credit
markets, the auction events for some of these instruments held by the Company failed during the
three months ended March 31, 2008 (see Note 3). Therefore, the fair values of these auction rate
floating securities, which are primarily rated AAA, are estimated utilizing a discounted cash flow
analysis as of June 30, 2010. These analyses consider, among other items, the collateralization
underlying the security investments, the creditworthiness of the counterparty, the timing of
expected future cash flows, and the expectation of the next time the security is expected to have a
successful auction. These investments
10
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.
The Companys assets measured at fair value on a recurring basis subject to the disclosure
requirements of ASC 820, Fair Value Measurements and Disclosures, at June 30, 2010, were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at Reporting Date Using |
|
|
|
|
|
|
|
Quoted |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Prices in |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
|
Active |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
|
Markets |
|
|
Inputs |
|
|
Inputs |
|
|
|
June 30, 2010 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Corporate notes and bonds |
|
$ |
125,522 |
|
|
$ |
125,522 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and bonds |
|
|
355,887 |
|
|
|
355,887 |
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
24,175 |
|
|
|
|
|
|
|
|
|
|
|
24,175 |
|
Asset-backed securities |
|
|
621 |
|
|
|
621 |
|
|
|
|
|
|
|
|
|
Investment in Hyperion |
|
|
2,375 |
|
|
|
|
|
|
|
|
|
|
|
2,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
508,580 |
|
|
$ |
482,030 |
|
|
$ |
|
|
|
$ |
26,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
The following tables present the Companys assets measured at fair value on a recurring
basis using significant unobservable inputs (Level 3) for the three and six months ended June 30,
2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements |
|
|
|
Using Significant Unobservable |
|
|
|
Inputs (Level 3) |
|
|
|
Auction |
|
|
|
|
|
|
Rate |
|
|
Investment |
|
|
|
Floating |
|
|
in |
|
|
|
Securities |
|
|
Hyperion |
|
|
Balance at March 31, 2010 |
|
$ |
26,254 |
|
|
$ |
2,375 |
|
Total gains
(losses) included in other expense, net |
|
|
|
|
|
|
|
|
Total gains
included in other comprehensive income |
|
|
596 |
|
|
|
|
|
Purchases and settlements, net |
|
|
(2,675 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
$ |
24,175 |
|
|
$ |
2,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements |
|
|
|
Using Significant Unobservable |
|
|
|
Inputs (Level 3) |
|
|
|
Auction |
|
|
|
|
|
|
Rate |
|
|
Investment |
|
|
|
Floating |
|
|
in |
|
|
|
Securities |
|
|
Hyperion |
|
|
Balance at December 31, 2009 |
|
$ |
26,821 |
|
|
$ |
2,375 |
|
Total gains
(losses) included in other expense, net |
|
|
|
|
|
|
|
|
Total gains
included in other comprehensive income |
|
|
629 |
|
|
|
|
|
Purchases and settlements, net |
|
|
(3,275 |
) |
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
$ |
24,175 |
|
|
$ |
2,375 |
|
|
|
|
|
|
|
|
5. SALE OF MEDICIS PEDIATRICS
On June 10, 2009, Medicis, Medicis Pediatrics, Inc. (Medicis Pediatrics, formerly known as
Ascent Pediatrics, Inc.), a wholly-owned subsidiary of Medicis, and BioMarin Pharmaceutical Inc.
(BioMarin) entered into an amendment (the Amendment) to the Securities Purchase Agreement (the
BioMarin Securities Purchase Agreement), dated as of May 18, 2004, and amended on January 12,
2005, by and among Medicis, Medicis Pediatrics, BioMarin and BioMarin Pediatrics Inc., a
wholly-owned subsidiary of BioMarin that previously merged into BioMarin. The Amendment was
effected to accelerate the closing of BioMarins option under the BioMarin Securities Purchase
Agreement to purchase from Medicis all of the issued and outstanding capital stock of Medicis
Pediatrics (the Option), which was previously expected to close in August 2009. In accordance
with the Amendment, the parties consummated the closing of the Option on June 10, 2009 (the
BioMarin Option Closing). The aggregate cash consideration paid to Medicis in conjunction with
the BioMarin Option Closing was approximately $70.3 million and the purchase was completed
substantially in accordance with the previously disclosed terms of the BioMarin Securities Purchase
Agreement.
As a result of the BioMarin Option Closing, the Company recognized a pretax gain
of $2.2 million during the three months ended June 30, 2009, which is included in other (income)
expense, net, in the condensed consolidated statements of income. The $2.2 million pretax gain is
net of approximately $0.7 million of
12
professional fees related to the transaction. Because of the difference between the Companys
book and tax basis of goodwill in Medicis Pediatrics, the transaction resulted in a $24.8 million
gain for income tax purposes, and, accordingly, the Company recorded a $9.0 million income tax
provision related to this transaction during the three months ended June 30, 2009, which is
included in income tax expense in the condensed consolidated statements of income.
6. INVESTMENT IN REVANCE
On December 11, 2007, the Company announced a strategic collaboration with Revance, a
privately-held, venture-backed development-stage entity, whereby the Company made an equity
investment in Revance and purchased an option to acquire Revance or to license exclusively in North
America Revances novel topical botulinum toxin type A product currently under clinical
development. The consideration to be paid to Revance upon the Companys exercise of the option
will be at an amount that will approximate the then fair value of Revance or the license of the
product under development, as determined by an independent appraisal. The option period will
extend through the end of Phase 2 testing in the United States. In consideration for the Companys
$20.0 million payment, the Company received preferred stock representing an approximate 13.7
percent ownership in Revance, or approximately 11.7 percent on a fully diluted basis, and the
option to acquire Revance or to license the product under development. The $20.0 million was used
by Revance primarily for the development of the product. Approximately $12.0 million of the $20.0
million payment represented the fair value of the investment in Revance at the time of the
investment and was included in other long-term assets in the Companys condensed consolidated
balance sheets as of December 31, 2007. The remaining $8.0 million, which is non-refundable and
was expected to be utilized in the development of the new product, represented the residual value
of the option to acquire Revance or to license the product under development and was recognized as
research and development expense during the three months ended December 31, 2007.
Prior to the exercise of the option, Revance will remain primarily responsible for the
worldwide development of Revances topical botulinum toxin type A product in consultation with the
Company in North America. The Company will assume primary responsibility for the development of
the product should consummation of either a merger or a license for topically delivered botulinum
toxin type A in North America be completed under the terms of the option. Revance will have sole
responsibility for manufacturing the development product and manufacturing the product during
commercialization worldwide. The Companys right to exercise the option is triggered upon
Revances successful completion of certain regulatory milestones through the end of Phase 2 testing
in the U.S. A license would contain a payment upon exercise of the license option, milestone
payments related to clinical, regulatory and commercial achievements, and royalties based on sales
defined in the license. If the Company elects to exercise the option, the financial terms for the
acquisition or license will be determined through an independent valuation in accordance with
specified methodologies.
The Company estimated the impairment and/or the net realizable value of the investment based
on a hypothetical liquidation at book value approach as of the reporting date, unless a
quantitative valuation metric was available for these purposes (such as the completion of an equity
financing by Revance). During the three months ended March 31, 2009, the Company reduced the
carrying value of its investment in Revance by approximately $2.9 million, as a result of a
reduction in the estimated net realizable value of the investment using the hypothetical
liquidation at book value approach. Such amount was recognized in other (income) expense. As a
result of this reduction, the Companys investment in Revance as of March 31, 2009 was $0. As of
June 30, 2010, the Companys investment in Revance related to this transaction was $0.
A business entity is subject to consolidation rules and is referred to as a variable interest
entity if it lacks sufficient equity to finance its activities without additional financial support
from other parties or its equity holders lack adequate decision making ability based on certain
criteria. Disclosures are required about variable interest entities that a company is not required
to consolidate, but in which a company has a significant variable interest. The Company has
determined that Revance is a variable interest entity and that the Company is not the primary
beneficiary, and therefore the Companys equity investment in Revance currently does not require
the Company to consolidate Revance into its financial statements. The consolidation status could
change in the future, however, depending on changes in the Companys relationship with Revance.
13
7. STRATEGIC COLLABORATIONS
Perrigo
On April 8, 2009, the Company entered into a License and Settlement Agreement (the Perrigo
License and Settlement Agreement) and a Joint Development Agreement (the Perrigo 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 Perrigo License and Settlement Agreement, the Company and Perrigo
agreed to terminate all legal disputes between them relating to the Companys VANOS®
fluocinonide Cream 0.1%. On April 17, 2009, the Court entered a consent judgment dismissing all
claims and counterclaims between Medicis and Perrigo, and enjoining Perrigo from marketing a
generic version of VANOS® other than under the terms of the Perrigo License and
Settlement Agreement. 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 Abbreviated New Drug Application (ANDA) #090256. Further, subject to
the terms and conditions contained in the Perrigo 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 Perrigo Joint Development Agreement, subject to the terms and conditions
contained therein:
|
|
|
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 U.S. Food and Drug Administration (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 made 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. |
During the three months ended September 30, 2009, a development milestone was achieved, and
the Company made a $2.0 million payment to Perrigo pursuant to the Perrigo Joint Development
Agreement. The $3.0 million up-front payment and the $2.0 million development milestone payment
were recognized as research and development expense during the three months ended June 30, 2009 and
September 30, 2009, respectively.
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 ANDA #09-024.
14
Under the terms of the License and Settlement Agreement, IMPAX has a license to market its
generic versions of SOLODYN® 45mg, 90mg and 135mg under the SOLODYN® patent
rights belonging to the Company upon the occurrence of specific events. Upon launch of its generic
formulations of SOLODYN®, IMPAX may be required to pay the Company a royalty, based on
sales of those generic formulations by IMPAX under terms described in the License and Settlement
Agreement.
Under the Joint Development Agreement, the Company and IMPAX will collaborate on the
development of five strategic dermatology product opportunities, including an advanced-form
SOLODYN® product. Under terms of the agreement, the Company made an initial payment of
$40.0 million upon execution of the agreement. During the three months ended March 31, 2009,
September 30, 2009 and December 31, 2009, the Company paid IMPAX $5.0 million, $5.0 million and
$2.0 million, respectively, upon the achievement of three separate clinical milestones, in
accordance with terms of the agreement. In addition, the Company will be required to pay up to
$11.0 million upon successful completion of certain other clinical and commercial milestones. The
Company will also make royalty payments based on sales of the advanced-form SOLODYN®
product if and when it is commercialized by the Company upon approval by the FDA. The Company will
share equally in the gross profit of the other four development products if and when they are
commercialized by IMPAX upon approval by the FDA.
The $40.0 million initial payment was recognized as research and development expense during
2008, and the $5.0 million, $5.0 million and $2.0 million clinical milestone achievement payments
were recognized as research and development expense during the three months ended March 31, 2009,
September 30, 2009 and December 31, 2009, respectively.
8. SEGMENT AND PRODUCT INFORMATION
The Company operates in one significant business segment: pharmaceuticals. The Companys
current pharmaceutical franchises are divided between the dermatological and non-dermatological
fields. The dermatological field represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological conditions. The non-dermatological field
represents products for the treatment of urea cycle disorder, non-invasive body sculpting
technology and contract revenue. The acne and acne-related dermatological product lines include
DYNACIN®, PLEXION®, SOLODYN®, TRIAZ® and
ZIANA®. The non-acne dermatological product lines include DYSPORT®,
LOPROX®, PERLANE®, RESTYLANE® and VANOS®. The
non-dermatological product lines include AMMONUL®, BUPHENYL® and the
LIPOSONIXTM system. The non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generics.
The Companys pharmaceutical products, with the exception of AMMONUL® and
BUPHENYL®, are promoted to dermatologists, podiatrists, and plastic surgeons. Such
products are often prescribed by physicians outside these three specialties; including family
practitioners, general practitioners, primary-care physicians and OB/GYNs, as well as hospitals,
government agencies, and others. Currently, the Companys products are sold primarily to
wholesalers and retail chain drug stores.
15
Net revenues and the percentage of net revenues for each of the product categories are as
follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Acne and acne-related
dermatological products |
|
$ |
124,763 |
|
|
$ |
94,185 |
|
|
$ |
244,976 |
|
|
$ |
160,638 |
|
Non-acne dermatological products |
|
|
41,017 |
|
|
|
37,100 |
|
|
|
75,269 |
|
|
|
60,573 |
|
Non-dermatological products |
|
|
8,265 |
|
|
|
9,961 |
|
|
|
20,290 |
|
|
|
19,853 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
174,045 |
|
|
$ |
141,246 |
|
|
$ |
340,535 |
|
|
$ |
241,064 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Acne and acne-related
dermatological products |
|
|
72 |
% |
|
|
67 |
% |
|
|
72 |
% |
|
|
67 |
% |
Non-acne dermatological products |
|
|
23 |
|
|
|
26 |
|
|
|
22 |
|
|
|
25 |
|
Non-dermatological products |
|
|
5 |
|
|
|
7 |
|
|
|
6 |
|
|
|
8 |
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
9. INVENTORIES
The Company primarily utilizes third parties to manufacture and package inventories held for
sale, takes title to certain inventories once manufactured, and warehouses such goods until
packaged for final distribution and sale. Inventories consist of salable products held at the
Companys warehouses, as well as raw materials and components at the manufacturers facilities, and
are valued at the lower of cost or market using the first-in, first-out method. The 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 June 30, 2010 and December 31, 2009, there were $0.8 million and $0.3 million,
respectively, of costs capitalized into inventory for products that have not yet received
regulatory approval.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
|
December 31, 2009 |
|
|
Raw materials |
|
$ |
13,352 |
|
|
$ |
7,472 |
|
Work-in-process |
|
|
2,544 |
|
|
|
3,660 |
|
Finished goods |
|
|
26,613 |
|
|
|
21,087 |
|
Valuation reserve |
|
|
(5,258 |
) |
|
|
(6,234 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
37,251 |
|
|
$ |
25,985 |
|
|
|
|
|
|
|
|
Selling, general and administrative costs capitalized into inventory during the three months
ended June 30, 2010 and 2009 were $0.4 million and $0.4 million, respectively. Selling, general
and administrative costs capitalized into inventory during the six months ended June 30, 2010 and
2009 was $0.8 million and $0.7 million,
16
respectively. Selling, general and administrative expenses included in inventory as of June
30, 2010 and December 31, 2009 were $1.5 million and $1.2 million, respectively.
10. OTHER CURRENT LIABILITIES
Other current liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
|
December 31, 2009 |
|
|
Accrued incentives, including SARs liability |
|
$ |
23,013 |
|
|
$ |
26,671 |
|
Deferred revenue |
|
|
18,847 |
|
|
|
18,508 |
|
Other accrued expenses |
|
|
29,606 |
|
|
|
23,202 |
|
|
|
|
|
|
|
|
|
|
$ |
71,466 |
|
|
$ |
68,381 |
|
|
|
|
|
|
|
|
Included in deferred revenue as
of June 30, 2010 and December 31, 2009, were $14.1 million and
$15.4 million, respectively, associated with the deferral of revenue of our aesthetics products,
including RESTYLANE®, PERLANE® and DYSPORT®, until our exclusive
U.S. distributor ships the product to physicians.
11. 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
June 30, 2010 or December 31, 2009. The Old Notes will mature on June 4, 2032.
The Company may redeem some or all of the Old Notes at any time on or after June 11, 2007, at
a redemption price, payable in cash, of 100% of the principal amount of the Old Notes, plus accrued
and unpaid interest, including contingent interest, if any. Holders of the Old Notes may require
the Company to repurchase all or a portion of their Old Notes on June 4, 2012 and June 4, 2017, or
upon a change in control, as defined in the indenture governing the Old Notes, at 100% of the
principal amount of the Old Notes, plus accrued and unpaid interest to the date of the repurchase,
payable in cash. Under GAAP, if an obligation is due on demand or will be due on demand within one
year from the balance sheet date, even though liquidation may not be expected within that period,
it should be classified as a current liability. Accordingly, the outstanding balance of Old Notes
along with the deferred tax liability associated with accelerated interest deductions on the Old
Notes will be classified as a current liability during the respective twelve month periods prior to
June 4, 2012 and June 4, 2017.
The Old Notes are convertible, at the holders option, prior to the maturity date into shares
of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after June 30, 2002, if the closing price of the Companys
Class A common stock over a specified number of trading days during the previous quarter,
including the last trading day of such quarter, is more than 110% of the conversion price
of the Old Notes, or $31.96. The Old Notes are initially convertible at a conversion price
of $29.05 per share, which is equal to a conversion rate of approximately 34.4234 shares
per $1,000 principal amount of Old Notes, subject to adjustment; |
|
|
|
|
if the Company has called the Old Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the Old Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
Old Notes; or |
17
|
|
|
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 June 30, 2010 or December 31, 2009.
The New Notes mature on June 4, 2033.
As a result of the exchange, the outstanding principal amounts of the Old Notes and the New
Notes were $169.2 million and $283.9 million, respectively. The Company incurred approximately
$5.1 million of fees and other origination costs related to the issuance of the New Notes. The
Company amortized these costs over the first five-year Put period, which ran through June 4, 2008.
Holders of the New Notes were able to require the Company to repurchase all or a portion of
their New Notes on June 4, 2008, at 100% of the principal amount of the New Notes, plus accrued and
unpaid interest, including contingent interest, if any, to the date of the repurchase, payable in
cash. Holders of approximately $283.7 million of New Notes elected to require the Company to
repurchase their New Notes on June 4, 2008. The Company paid $283.7 million, plus accrued and
unpaid interest of approximately $2.2 million, to the holders of New Notes that elected to require
the Company to repurchase their New Notes. The Company was also required to pay an accumulated
deferred tax liability of approximately $34.9 million related to the repurchased New Notes. This
$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
June 30, 2010 and December 31, 2009.
The remaining New Notes are convertible, at the holders option, prior to the maturity date
into shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after September 30, 2003, if the closing price of the
Companys Class A common stock over a specified number of trading days during the previous
quarter, including the last trading day of such quarter, is more than 120% of the
conversion price of the New Notes, or $46.51. The Notes are initially convertible at a
conversion price of $38.76 per share, which is equal to a conversion rate of approximately
25.7998 shares per $1,000 principal amount of New Notes, subject to adjustment; |
|
|
|
|
if the Company has called the New Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the New Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
New Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
18
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 June 30, 2010, March 31, 2010 and December 31, 2009, the Old Notes
and New Notes did not meet the criteria for the right of conversion. At the end of each future
quarter, the conversion rights will be reassessed in accordance with the bond indenture agreement
to determine if the conversion trigger rights have been achieved.
12. INCOME TAXES
Income taxes are determined using an annual effective tax rate, which generally differs from
the U.S. Federal statutory rate, primarily because of state and local income taxes, enhanced
charitable contribution deductions for inventory, tax credits available in the U.S., the treatment
of certain share-based payments that are not designed to normally result in tax deductions, various
expenses that are not deductible for tax purposes, changes in valuation allowances against deferred
tax assets and differences in tax rates in certain non-U.S. jurisdictions. The Companys effective
tax rate may be subject to fluctuations during the year as new information is obtained which may
affect the assumptions it uses to estimate its annual effective tax rate, including factors such as
its mix of pre-tax earnings in the various tax jurisdictions in which it operates, changes in
valuation allowances against deferred tax assets, reserves for tax audit issues and settlements,
utilization of tax credits and changes in tax laws in jurisdictions where the Company conducts
operations. The Company recognizes tax benefits only if the tax position is more likely than not
of being sustained. The Company recognizes deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax basis of its assets and liabilities,
along with net operating losses and credit carryforwards. The Company records valuation allowances
against its deferred tax assets to reduce the net carrying value to amounts that management
believes is more likely than not to be realized.
At June 30, 2010, the Company has an unrealized tax loss of $21.0 million related to the
Companys option to acquire Revance or license Revances topical product that is under development.
The Company will not be able to determine the character of the loss until the Company exercises or
fails to exercise its option. A realized loss characterized as a capital loss can only be utilized
to offset capital gains. At June 30, 2010, 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 June 30, 2010 and June 30, 2009, the Company made net tax
payments of $30.9 million and $2.1 million, respectively. During the six months ended June 30,
2010 and June 30, 2009, the Company made net tax payments of $47.7 million and $3.6 million,
respectively.
The Company operates in multiple tax jurisdictions and is periodically subject to audit in
these jurisdictions. These audits can involve complex issues that may require an extended period
of time to resolve and may cover multiple years. The Company and its domestic subsidiaries file a
consolidated U.S. federal income tax return. Such returns have either been audited or settled
through statute expiration through 2005. The state of California is currently conducting an
examination on the Companys tax returns for the periods ending June 30, 2005, December 31, 2005,
December 31, 2006 and December 31, 2007. The state has proposed audit adjustments. The Company
has recorded adequate accruals for these proposed adjustments.
The Company owns two subsidiaries that file corporate tax returns in Sweden. The Swedish tax
authorities examined the tax return of one of the subsidiaries for fiscal 2004. The examiners
issued a no change letter, and the examination is complete. The Companys other subsidiary in
Sweden has not been examined by the Swedish tax authorities. The Swedish statute of limitation may
be open for up to five years from the date the tax return was filed. Thus, all returns filed from
fiscal 2005 forward are open under the statute of limitation.
At June 30, 2010 and December 31, 2009, the Company had $2.3 million in unrecognized tax
benefits, the recognition of which would have a favorable effect of $1.7 million on the Companys
effective tax rate. During the next twelve months, the Company estimates that it is reasonably
possible that the amount of unrecognized tax benefits will decrease by $0.8 million due to normal
statute closures.
19
The Company recognizes accrued interest and penalties, if applicable, related to unrecognized
tax benefits in income tax expense. The Company had approximately $0.5 million for the payment of
interest and penalties accrued (net of tax benefit) at June 30, 2010 and December 31, 2009.
13. DIVIDENDS DECLARED ON COMMON STOCK
On June 9, 2010, the Company announced that its Board of Directors had declared a cash
dividend of $0.06 per issued and outstanding share of the Companys Class A common stock payable on
July 30, 2010, to stockholders of record at the close of business on July 1, 2010. The $3.6
million dividend was recorded as a reduction of accumulated earnings and is included in other
current liabilities in the accompanying condensed consolidated balance sheets as of June 30, 2010.
The Company has not adopted a dividend policy.
14. 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 June 30,
2010 and 2009, was $36.9 million and $14.4 million, respectively. Total comprehensive income for
the six months ended June 30, 2010 and 2009, was $72.9 million and $14.7 million, respectively.
20
15. 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 |
|
|
Six Months Ended |
|
|
|
June 30, 2010 |
|
|
June 30, 2009 |
|
|
June 30, 2010 |
|
|
June 30, 2009 |
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
36,499 |
|
|
$ |
15,593 |
|
|
$ |
71,869 |
|
|
$ |
15,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: income allocated to participating securities |
|
|
1,205 |
|
|
|
526 |
|
|
|
2,368 |
|
|
|
467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stockholders |
|
|
35,294 |
|
|
|
15,067 |
|
|
|
69,501 |
|
|
|
15,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
58,271 |
|
|
|
57,088 |
|
|
|
58,161 |
|
|
|
56,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share |
|
$ |
0.61 |
|
|
$ |
0.26 |
|
|
$ |
1.19 |
|
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
36,499 |
|
|
$ |
15,593 |
|
|
$ |
71,869 |
|
|
$ |
15,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: income allocated to participating securities |
|
|
1,205 |
|
|
|
526 |
|
|
|
2,368 |
|
|
|
467 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stockholders |
|
|
35,294 |
|
|
|
15,067 |
|
|
|
69,501 |
|
|
|
15,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings allocated to unvested stockholders |
|
|
(1,113 |
) |
|
|
(453 |
) |
|
|
(2,170 |
) |
|
|
(342 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings re-allocated to unvested
stockholders |
|
|
1,107 |
|
|
|
452 |
|
|
|
2,159 |
|
|
|
341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense and issue costs
related to Old Notes |
|
|
666 |
|
|
|
666 |
|
|
|
1,332 |
|
|
|
1,332 |
|
Tax-effected interest expense and issue costs
related to New Notes |
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income assuming dilution |
|
$ |
35,954 |
|
|
$ |
15,732 |
|
|
$ |
70,823 |
|
|
$ |
16,786 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
58,271 |
|
|
|
57,088 |
|
|
|
58,161 |
|
|
|
56,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
5,823 |
|
New Notes |
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
|
|
4 |
|
Stock options |
|
|
297 |
|
|
|
93 |
|
|
|
306 |
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares assuming dilution |
|
|
64,395 |
|
|
|
63,008 |
|
|
|
64,294 |
|
|
|
62,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share |
|
$ |
0.56 |
|
|
$ |
0.25 |
|
|
$ |
1.10 |
|
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share must be calculated using the if-converted method.
Diluted net income per share using the if-converted method is calculated by adjusting net income
for tax-effected net interest
21
and issue costs on the Old Notes and New Notes, divided by the weighted average number of common
shares outstanding assuming conversion.
Unvested share-based payment awards that contain rights to receive nonforfeitable dividends or
dividend equivalents (whether paid or unpaid) are participating securities, and thus, are included
in the two-class method of computing earnings per share. The two-class method is an earnings
allocation formula that treats a participating security as having rights to earnings that would
otherwise have been available to common stockholders. Restricted stock granted to certain
employees by the Company (see Note 2) participate in dividends on the same basis as common shares,
and these dividends are not forfeitable by the holders of the restricted stock. As a result, the
restricted stock grants meet the definition of a participating security.
The diluted net income per common share computation for the three and six months ended June
30, 2010 excludes 8,027,204 and 8,559,315 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 and six months ended June 30, 2009 excludes 10,679,752 and 11,266,093
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.
16. COMMITMENTS AND CONTINGENCIES
Lease Exit Costs
In connection with occupancy of the new headquarter office, the Company ceased use of the
prior headquarter office in July 2008, which consists of approximately 75,000 square feet of office
space, at an average annual expense of approximately $2.1 million, under an amended lease agreement
that expires in December 2010. Under ASC 420, Exit or Disposal Cost Obligations, a liability for
the costs associated with an exit or disposal activity is recognized when the liability is
incurred. The Company recorded lease exit costs of approximately $4.8 million during the three
months ended September 30, 2008, consisting of the initial liability of $4.7 million and accretion
expense of $0.1 million. These amounts were recorded as selling, general and administrative
expenses. The Company has not recorded any other costs related to the lease for the prior
headquarters, other than accretion expense.
As of June 30, 2010, approximately $1.1 million of lease exit costs remain accrued and are
expected to be paid by December 2010, all of which is classified in other current liabilities.
Although the facilities are no longer in use by the Company, the lease exit cost accrual has not
been offset by an adjustment for estimated sublease rentals. After considering sublease market
information as well as factors specific to the lease, the Company concluded it was probable it
would be unable to obtain sublease rentals for the prior headquarters, and, therefore, it would not
be subleased for the remaining lease term. The Company will continue to monitor the sublease
market conditions and reassess the impact on the lease exit cost accrual.
The following is a summary of the activity in the liability for lease exit costs for the six
months ended June 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2009 |
|
to Expense |
|
Made |
|
from Sublease |
|
June 30, 2010 |
Lease exit costs
liability |
|
$ |
2,063,677 |
|
|
$ |
58,664 |
|
|
$ |
(1,069,056 |
) |
|
$ |
|
|
|
$ |
1,053,285 |
|
Legal Matters
On January 13, 2009, the Company filed suit against Mylan, Inc., Matrix Laboratories Ltd.,
Matrix Laboratories Inc., Sandoz, Inc. (Sandoz) and Barr Laboratories, Inc. (Barr)
(collectively Defendants) in the United States District Court for the District of Delaware
seeking an adjudication that Defendants have infringed one or more claims of the Companys U.S.
Patent No. 5,908,838 (the 838 Patent) related to the Companys acne medication
SOLODYN®, by submitting to the FDA their respective ANDAs for generic versions of
SOLODYN® in its forms of 45mg, 90mg, and 135mg strengths. The relief requested by the
Company included a request for a
22
permanent injunction preventing Defendants from infringing the 838 Patent by selling generic
versions of SOLODYN®. The expiration date for the 838 Patent is in 2018. On March 18,
2009, the Company entered into a settlement agreement with Barr, a subsidiary of Teva
Pharmaceutical Industries Ltd. (Teva), whereby all legal disputes between the Company and Teva
relating to SOLODYN® were terminated and whereby Barr/Teva agreed that Medicis
patent-in-suit is valid, enforceable and not infringed and that it should be permanently enjoined
from infringement. The Delaware court subsequently entered a permanent injunction against any
infringement by Barr/Teva. On March 30, 2009, the Delaware Court dismissed the claims between the
Company and Matrix Laboratories Inc. without prejudice, pursuant to a stipulation between Medicis
and Matrix Laboratories Inc. On August 18, 2009, the Company entered into a Settlement Agreement
with Sandoz whereby all legal disputes between the Company and Sandoz relating to
SOLODYN® were terminated and whereby Sandoz agreed that Medicis patent-in-suit is
valid, enforceable and not infringed and that it should be permanently enjoined from infringement.
The Delaware court subsequently entered a permanent injunction against any infringement by Sandoz.
On May 6, 2009, the Company received a Paragraph IV Patent Certification from Ranbaxy
Laboratories Limited (Ranbaxy Limited) advising that Ranbaxy Limited had filed an ANDA with the
FDA for generic SOLODYN® in its form of 135mg strength. Ranbaxy Limiteds Paragraph IV
Certification alleged that Ranbaxy Limiteds manufacture, use, sale or offer for sale of the
product for which the ANDA was submitted would not infringe any valid claim of the Companys 838
Patent. On June 11, 2009, the Company filed suit against Ranbaxy Limited and Ranbaxy Inc.
(collectively, Ranbaxy) in the United States District Court for the District of Delaware seeking
an adjudication that Ranbaxy has infringed one or more claims of the 838 Patent by submitting the
above ANDA to the FDA. The relief the Company requested included a request for a permanent
injunction preventing Ranbaxy from infringing the 838 Patent by selling a generic version of
SOLODYN®.
On September 24, 2009, the Delaware District Court held a scheduling hearing and ordered that
the Mylan and Ranbaxy cases be consolidated and that in both cases trial would commence in May
2010. The parties filed opening claim construction briefs on December 15, 2009, and answering
claim construction briefs on January 8, 2010. On March 25, 2010, the Delaware District Court
cancelled the April 8, 2010 pretrial conference and the May 7, 2010 trial, and referred the case to
Magistrate Judge Stark to hear and address the scheduling of trial and related matters.
On January 5, 2010, the Company received a Paragraph IV Patent Certification from Ranbaxy
advising that Ranbaxy had filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-118 (Ranbaxy ANDA Supplement/Amendment I) with the FDA for generic SOLODYN® in its
forms of 45mg and 90mg strengths. Ranbaxys Paragraph IV Certification alleged that the Companys
838 Patent is invalid, unenforceable, and/or will not be infringed by Ranbaxys manufacture,
importation, use, sale and/or offer for sale of the products for which the Ranbaxy ANDA
Supplement/Amendment I was submitted. Ranbaxys Paragraph IV Certification also alleged that the
Companys U.S. Patent No. 7,541,347 (the 347 Patent) or 7,544,373 (the 373 Patent) is not
infringed by Ranbaxys manufacture, importation, use, sale and/or offer for sale of the products
for which the ANDA Supplement/Amendment I was submitted. The expiration dates for the 347 and 373
Patents are in 2027. Ranbaxys submission as to the 45mg and 90mg strengths amended an ANDA
already subject to a 30-month stay. As such, the Company believes that the Ranbaxy ANDA
Supplement/Amendment I could not be approved by the FDA until after the expiration of the 30-month
period or in the event of a court decision holding that the patents are invalid or not infringed.
On February 16, 2010, the Company filed suit against Ranbaxy in the United States District Court
for the District of Delaware seeking an adjudication that Ranbaxy infringed one or more claims of
the patents by submitting the Ranbaxy ANDA Supplement/Amendment I for generic SOLODYN®
in its forms of 45mg and 90mg strengths. The relief requested by the Company included a request
for a permanent injunction preventing Ranbaxy from infringing the 838 patent by selling generic
versions of SOLODYN®.
On April 15, 2010, the Company received a Paragraph IV Patent Certification from Ranbaxy
advising that Ranbaxy had filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-118 (Ranbaxy ANDA Supplement/Amendment II) with the FDA for generic SOLODYN® in
its forms of 65mg and 115mg strengths. Ranbaxys Paragraph IV Certification alleged that the
Companys 838 Patent is invalid, unenforceable, and/or will not be infringed by Ranbaxys
manufacture, importation, use, sale and/or offer for sale of the products for which the Ranbaxy
ANDA Supplement/Amendment II was submitted. Ranbaxys submission as to the 65mg and 115mg
strengths amended an ANDA already subject to a 30-month stay. As such, the Company believes that
the supplement or amendment could not be approved by the FDA until after the expiration of the
30-month period or in the event of a court decision holding that the patent is invalid or not
infringed.
23
On May 4, 2010, the Company entered into a License and Settlement Agreement (the Ranbaxy
Settlement Agreement) with Ranbaxy. Pursuant to the Settlement Agreement, the Company and Ranbaxy
agreed to terminate all legal disputes between them relating to SOLODYN®. In addition,
Ranbaxy confirmed that the Companys patents relating to SOLODYN® are valid and
enforceable, and cover Ranbaxys activities relating to Ranbaxys generic SOLODYN®
products under ANDA #91-118. Ranbaxy also agreed to be permanently enjoined from any distribution
of generic SOLODYN® except pursuant to the terms of the Ranbaxy Settlement Agreement.
Under the Ranbaxy Settlement Agreement, the Company granted to Ranbaxy a license to make and sell
its generic version of SOLODYN® 45mg, 90mg and 135mg under the SOLODYN®
intellectual property rights belonging to the Company commencing in November 2011, or earlier under
certain conditions. The Company also granted to Ranbaxy a license to make and sell generic
versions of SOLODYN® 65mg and 115mg under the Companys SOLODYN® intellectual
property rights upon certain conditions but not upon any specified date in the future. The Ranbaxy
Settlement Agreement provides that Ranbaxy will be required to pay the Company royalties based on
sales of Ranbaxys generic SOLODYN® products pursuant to the foregoing licenses. In
addition, the Ranbaxy Settlement Agreement provides for the Companys grant to Ranbaxy of a license
to make and sell a branded proprietary dermatology product currently under development by Ranbaxy,
which is not therapeutically equivalent to any of the Companys currently marketed dermatology
products, under certain intellectual property rights belonging to the Company, commencing the later
of August 2011 or upon the sale of such product by Ranbaxy following approval by the FDA. Ranbaxy
will be required to pay the Company a royalty based on sales of such product pursuant to the
license.
On October 8, 2009, the Company received a Paragraph IV Patent Certification from Lupin
advising that Lupin had filed an ANDA with the FDA for generic SOLODYN® in its forms of
45mg, 90mg, and 135mg strengths. Lupin did not advise the Company as to the timing or status of
the FDAs review of its filing, or whether it has complied with FDA requirements for proving
bioequivalence. Lupins Paragraph IV Certification alleges that the Companys 838 Patent is
invalid. Lupins Paragraph IV Certification also alleges that the Companys 347 Patent or 373
Patent is not infringed by Lupins manufacture, importation, use, sale and/or offer for sale of the
products for which the Lupin ANDA was submitted. On November 17, 2009, the Company filed suit
against Lupin in the United States District Court for the District of Maryland seeking an
adjudication that Lupin has infringed one or more claims of the 838 Patent by submitting to the
FDA an ANDA for generic SOLODYN® in its forms of 45mg, 90mg and 135mg strengths. The
relief the Company requested includes a request for a permanent injunction preventing Lupin from
infringing the 838 Patent by selling generic versions of SOLODYN®. On November 24,
2009, the Company received a Paragraph IV Patent Certification from Lupin, advising that Lupin has
filed a supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 (Lupin ANDA
Supplement/Amendment I) with the FDA for generic SOLODYN ® in its form of 65mg
strength. Lupin has not advised the Company as to the timing or status of the FDAs review of its
filing, or whether Lupin has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleges that the Companys 838 Patent is invalid. Lupins Paragraph IV
Certification also alleges that the Companys 347 Patent or 373 Patent is not infringed by
Lupins manufacture, importation, use, sale and/or offer for sale of the products for which the
Lupin ANDA Supplement/Amendment I was submitted. Lupins submission amends an ANDA already subject
to a 30-month stay. As such, the Company believes that the amendment cannot be approved by the
FDA until after the expiration of the 30-month period or a court decision that the patent is
invalid or not infringed.
On December 23, 2009, the Company received a Paragraph IV Patent Certification from Lupin,
advising that Lupin has filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-424 (Lupin ANDA Supplement/Amendment II) with the FDA for generic SOLODYN ® in its
form of 115mg strength. Lupin has not advised the Company as to the timing or status of the FDAs
review of its filing, or whether Lupin has complied with FDA requirements for proving
bioequivalence. Lupins Paragraph IV Certification alleges that the Companys 838 Patent is
invalid. Lupins Paragraph IV Certification also alleges that the Companys 347 Patent or 373
Patent is not infringed by Lupins manufacture, importation, use, sale and/or offer for sale of the
products for which the Lupin ANDA Supplement/Amendment II was submitted. Lupins submission amends
an ANDA already subject to a 30-month stay. As such, the Company believes that the amendment
cannot be approved by the FDA until after the expiration of the 30-month period or a court decision
that the patent is invalid or not infringed. On December 28, 2009, the Company amended its
complaint against Lupin in the United States District Court for the District of Maryland seeking an
adjudication that Lupin has infringed one or more claims of the 838 Patent by submitting its
supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 for generic SOLODYN®
in its form of 65mg strength. On February 2, 2010, the Company amended its complaint against
Lupin in the United States District Court for the District of Maryland seeking an adjudication that
Lupin has infringed one or more claims of
24
the 838 Patent by submitting its supplement or amendment to its earlier filed ANDA assigned
ANDA #91-424 for generic SOLODYN® in its form of 115mg strength.
On November 20, 2009, the Company received a Paragraph IV Patent Certification from Barr,
advising that Barr has filed a supplement to its earlier filed ANDA #65-485 (Barr ANDA
Supplement) with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths.
Barr has not advised the Company as to the timing or status of the FDAs review of its filing, or
whether Barr has complied with FDA requirements for proving bioequivalence. Barrs Paragraph IV
Certification alleges that the Companys 838 Patent is invalid, unenforceable and/or will not be
infringed by Barrs manufacture, use, sale and/or importation of the products for which the Barr
ANDA Supplement was submitted. On December 28, 2009, the Company filed suit against Barr and Teva
Pharmaceuticals USA, Inc., (collectively Barr/Teva USA) in the United States District Court for
the District of Maryland seeking an adjudication that Barr/Teva USA has infringed one or more
claims of the 838 Patent by submitting to the FDA the Barr ANDA Supplement for generic
SOLODYN® in its forms of 65mg and 115mg strengths. The relief the Company
requested includes a request for a permanent injunction preventing Barr/Teva USA from infringing
the 838 Patent by selling generic versions of SOLODYN® in its forms of 65mg
and 115mg strengths. As a result of the filing of the suit, the Company believes that the
supplement to the ANDA cannot be approved by the FDA until after the expiration of a 30-month stay
period or a court decision that the patent is invalid or not infringed.
On January 28, 2010, the Company received a Paragraph IV Patent Certification from Sandoz,
advising that Sandoz has filed a supplement to its earlier filed ANDA #91-422 (Sandoz ANDA
Supplement) with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths.
Sandoz has not advised the Company as to the timing or status of the FDAs review of its filing,
or whether Sandoz has complied with FDA requirements for proving bioequivalence. Sandozs
Paragraph IV Certification alleges that the Companys 838 Patent will not be infringed by Sandozs
manufacture, use, sale and/or importation of the products for which the Sandoz ANDA Supplement was
submitted because it has been granted a patent license by the Company for the 838 Patent.
On May 7, 2010, the Company received notice from Mylan Inc. that its majority owned subsidiary
Matrix Laboratories Limited (Matrix) had filed an ANDA containing a Paragraph IV Patent
Certification with the FDA for generic SOLODYN® in its forms of 65mg and 115mg
strengths. Mylan Inc. did not advise the Company as to the timing or status of the FDAs review of
Matrixs filing, or whether Matrix had complied with FDA requirements for proving bioequivalence.
The Paragraph IV Certification alleged that the Companys 838 Patent is invalid and/or will not be
infringed by Matrixs manufacture, use or sale of the products for which the ANDA was submitted.
On June 14, 2010, the Company filed suit against Mylan Inc. and Matrix in the United States
District Court for the District of Delaware seeking an adjudication that Matrix had infringed one
or more claims of the Companys 838 Patent by submitting to the FDA its ANDA for generic
SOLODYN® in its forms of 65mg and 115mg strengths. The relief requested by the Company
included a request for a permanent injunction preventing Matrix from infringing the 838 Patent by
selling generic versions of SOLODYN®. As a result of the filing of the suit, the
Company believes that the ANDA could not be approved by the FDA until after the expiration of a
30-month stay period or a court decision that the 838 Patent is invalid or not infringed.
A third party requested that the U.S. Patent and Trademark Office (USPTO) conduct an Ex
Parte Reexamination of the 838 Patent. The USPTO granted this request. In March 2009, the USPTO
issued a non-final office action in the reexamination of the 838 Patent. On May 13, 2009, Medicis
filed its response to the non-final office action with the USPTO, canceling certain claims and
adding amended claims. On November 10, 2009, the USPTO issued a second non-final office action in
the reexamination of the 838 Patent. On January 8, 2010, the Company filed its response to the
non-final office action with the USPTO. On March 17, 2010, the Company received a Notice of Intent
to Issue a Reexamination Certificate issued by the USPTO in connection with the USPTOs
reexamination of the 838 Patent. On June 1, 2010, the Company received the Reexamination
Certificate (the Reexamination Certificate) from the USPTO. The Reexamination Certificate is
directed to patentable claims 3, 4, 12, and 13, as well as new claims 19-34. The USPTO determined
that the claims are patentable, including over all the cited prior art. The claims are the subject
of patent infringement lawsuits filed by the Company in Maryland.
On July 1, 2010, the Company amended its complaint against Lupin in the United States District
Court for the District of Maryland relating to Lupins filing of its ANDA, and amendments or
supplements thereto, for generic SOLODYN® in its forms of 45mg, 65mg, 90mg,
115mg and 135mg strengths. The Company amended the complaint to assert new claims 19, 21, 23, 25
and 27-34 included in the Reexamination Certificate. The complaint
25
seeks an adjudication that Lupin has infringed one or more claims of the 838 Patent,
including the new claims, by submitting the ANDA, and amendments or supplements thereto, to the
FDA.
On July 8, 2010, the Company amended its complaint against Mylan Inc. and Matrix in the United
States District Court for the District of Delaware relating to Matrixs filing of its ANDA for
generic SOLODYN® in its forms of 45mg, 90mg and 135mg strengths. The Company
amended the complaint to assert new claims 19, 21, 23, 25 and 27-34 included in the Reexamination
Certificate. The complaint sought an adjudication that Matrix had infringed one or more claims of
the 838 Patent, including the new claims, by submitting the ANDA to the FDA.
On July 22, 2010, the Company entered into a Settlement Agreement and a License Agreement (the
Mylan License Agreement) with Mylan Inc. and certain of its affiliates, including Matrix and
Mylan Pharmaceuticals Inc. (collectively, Mylan). Pursuant to the agreements, the companies
agreed to terminate all legal disputes between them relating to SOLODYN®. In
addition, Mylan confirmed that the Companys patents relating to SOLODYN® are
valid and enforceable, and cover Mylans activities relating to Mylans generic
SOLODYN® products under its ANDAs described above. Mylan also acknowledged
that any prior sales of its generic SOLODYN® products were not authorized by
the Company, and agreed to be permanently enjoined from any further distribution of generic
SOLODYN® products except pursuant to the Mylan License Agreement as described
below. The Company agreed to release Mylan from liability arising from any prior sales of its
generic SOLODYN® products that were not authorized by the Company. Under the
Mylan License Agreement, the Company granted to Mylan a license to make and sell its generic
versions of SOLODYN® 45mg, 90mg and 135mg under the
SOLODYN® intellectual property rights belonging to the Company commencing in
November 2011, or earlier under certain conditions. The Company also granted to Mylan a license to
make and sell generic versions of SOLODYN® 65mg and 115mg under the Companys
SOLODYN® intellectual property rights upon certain conditions, but not upon
any specified date in the future. The Mylan License Agreement provides that Mylan will be required
to pay the Company royalties based on sales of Mylans generic SOLODYN®
products pursuant to the foregoing licenses.
On July 9, 2010, the Company amended its complaint against Barr/Teva USA in the United States
District Court for the District of Maryland relating to Barr/Teva USAs filing of its ANDA for
generic SOLODYN® in its forms of 65mg and 115mg strengths. The Company
amended the complaint to assert new claims 19, 21, 23, 25 and 27-34 included in the Reexamination
Certificate. The complaint seeks an adjudication that Barr/Teva USA has infringed one or more
claims of the 838 Patent, including the new claims, by submitting the ANDA to the FDA.
On March 17, 2010, the Company received a Paragraph IV Patent Certification from Taro
Pharmaceuticals U.S.A., Inc. (Taro U.S.A.) advising that Taro U.S.A. has filed an ANDA with the
FDA for a generic version of VANOS® (fluocinonide) Cream 0.1%. Taro U.S.A. has not
advised the Company as to the timing or status of the FDAs review of its filing, or whether Taro
U.S.A. has complied with FDA requirements for proving bioequivalence. Taro U.S.A.s Paragraph IV
Certification alleges that the Companys U.S. Patent No. 6,765,001 (the 001 Patent) and U.S.
Patent No. 7,220,424 (the 424 Patent) will not be infringed by Taro U.S.A.s manufacture, use,
sale or importation of the product for which the ANDA was submitted, and that claim 3 of the 424
Patent is invalid. On April 28, 2010, the Company filed suit against Taro U.S.A. and Taro
Pharmaceuticals Industries, Ltd. (collectively, Taro) in the United States District Court for the
District of Delaware and the United States District Court for the Southern District of New York
seeking an adjudication that Taro has infringed one or more claims of the 001 Patent, the 424
Patent and the Companys U.S. Patent No. 7,217,422 (the 422 Patent) by submitting the ANDA to
the FDA. The relief requested by the Company includes a request for a permanent injunction
preventing Taro from infringing the patents by selling a generic version of VANOS® prior
to the expiration of the asserted patents.
On April 7, 2010, the Company received a Paragraph IV Patent Certification from Nycomed US
Inc. (Nycomed) advising that Nycomed has filed an ANDA with the FDA for a generic version of
VANOS® (fluocinonide) Cream 0.1%. Nycomed has not advised the Company as to the timing
or status of the FDAs review of its filing, or whether Nycomed has complied with FDA requirements
for proving bioequivalence. Nycomeds Paragraph IV Certification alleges that the Companys 001
Patent and 424 Patent will not be infringed by Nycomeds manufacture, use, sale, offer for sale or
importation of the product for which the ANDA was submitted. On May 19, 2010, the Company filed
suit against Nycomed and Nycomed GmbH in the United States District Court for the District of
Delaware and the United States District Court for the Southern District of New York seeking an
26
adjudication that Nycomed has infringed one or more claims of the Companys 001 Patent, 424
Patent and 422 Patent by submitting the ANDA to the FDA. The relief requested by the Company
includes a request for a permanent injunction preventing Nycomed from infringing the patents by
selling a generic version of VANOS® prior to the expiration of the asserted patents.
On July 28, 2010, the Company filed suit against Stiefel Laboratories, Inc., a subsidiary
of GlaxoSmithKline plc (Stiefel), in the United States District Court for the Western District of
Texas San Antonio Division seeking a declaratory judgment that the manufacture and sale of
Stiefels acne product VELTIN Gel, which was recently approved by the FDA, will infringe one or
more claims of the Companys U.S. Patent No. RE41,134 (the 134 Patent) covering the Companys
product ZIANA® Gel, a prescription topical gel indicated for the treatment of acne that
was approved by the FDA in November 2006. The 134 Patent is listed in the FDAs Approved Drug
Products with Therapeutic Equivalence Evaluations (Orange Book) and expires in February 2015. The
Company has rights to the 134 Patent pursuant to an exclusive license agreement with the owner of
the patent. The relief requested by the Company in the lawsuit includes a request for a permanent
injunction preventing Stiefel from infringing the 134 Patent by engaging in the commercial
manufacture, use, importation, offer to sell, or sale of any therapeutic composition or method of
use covered by the 134 Patent, including such activities relating to VELTIN, and from inducing or
contributing to any such activities.
On October 3, 10, and 27, 2008, purported stockholder class action lawsuits styled Andrew Hall
v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01821-MHB); Steamfitters Local 449
Pension Fund v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01870-DKD); and Darlene
Oliver v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01964-JAT) were filed in the
United States District Court for the District of Arizona on behalf of stockholders who purchased
securities of the Company during the period between October 30, 2003 and approximately September
24, 2008. The Court consolidated these actions into a single proceeding and on May 18, 2009 an
amended complaint was filed alleging violations of the federal securities laws arising out of the
Companys restatement of its consolidated financial statements in 2008. On December 2, 2009, the
court dismissed the consolidated amended complaint without prejudice, and on January 18, 2010 the
lead plaintiff filed a second amended complaint. On February 19, 2010, the Company and the other
defendants filed motions to dismiss the second amended complaint in its entirety on various
grounds. The Company will continue to vigorously defend the claims in these consolidated matters.
There can be no assurance, however, that the Company will be successful, and an adverse resolution
of the lawsuits could have a material adverse effect on the Companys financial position and
results of operations in the period in which the lawsuits are resolved. The Company is not
presently able to reasonably estimate potential losses, if any, related to the lawsuits.
In addition to the matters discussed above, in the ordinary course of business, the Company is
involved in a number of legal actions, both as plaintiff and defendant, and could incur uninsured
liability in any one or more of them. Although the outcome of these actions is not presently
determinable, it is the opinion of the Companys management, based upon the information available
at this time, that the expected outcome of these matters, individually or in the aggregate, will
not have a material adverse effect on the results of operations, financial condition or cash flows
of the Company.
17. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
In October 2009, the FASB approved for issuance Accounting Standards Update (ASU) No.
2009-13, Revenue Recognition (ASC 605) Multiple Deliverable Revenue Arrangements, a consensus
of EITF 08-01, Revenue Arrangements with Multiple Deliverables. This guidance modifies the fair
value requirements of ASC subtopic 605-25 Revenue Recognition Multiple Element Arrangements by
providing principles for allocation of consideration among its multiple-elements, allowing more
flexibility in identifying and accounting for separate deliverables under an arrangement. An
estimated selling price method is introduced for valuing the elements of a bundled arrangement if
vendor-specific objective evidence or third-party evidence of selling price is not available, and
significantly expands related disclosure requirements. This updated guidance is effective on a
prospective basis for revenue arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and
early application is permitted. The Company is currently assessing what impact, if any, the
updated guidance will have on its results of operations and financial condition.
In March 2010, the FASB approved for issuance ASU No. 2010-17, Revenue Recognition-Milestone
Method (Topic 605): Milestone Method of Revenue Recognition. The updated guidance recognizes the
milestone method as an acceptable revenue recognition method for substantive milestones in research
or development transactions, and is
27
effective on a prospective basis for milestones achieved in fiscal years, and interim periods
within those years, beginning on or after June 15, 2010. Early adoption is permitted. The
Company is currently assessing what impact, if any, the updated guidance will have on its results
of operations and financial condition.
18. SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date of issuance of its financial
statements.
28
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Executive Summary
We are a leading independent specialty pharmaceutical company focused primarily on helping
patients attain a healthy and youthful appearance and self-image through the development and
marketing in the U.S. of products for the treatment of dermatological and aesthetic conditions. We
also market products in Canada for the treatment of dermatological and aesthetic conditions and
began commercial efforts in Europe with our acquisition of LipoSonix in July 2008. We offer a
broad range of products addressing various conditions or aesthetics improvements, including facial
wrinkles, acne, fungal infections, rosacea, hyperpigmentation, photoaging, psoriasis, seborrheic
dermatitis and cosmesis (improvement in the texture and appearance of skin).
Our current product lines are divided between the dermatological and non-dermatological
fields. The dermatological field represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological conditions. The non-dermatological field
represents products for the treatment of urea cycle disorder, non-invasive body sculpting
technology and contract revenue. Our acne and acne-related dermatological product lines include
DYNACIN®, PLEXION®, SOLODYN®, TRIAZ® and
ZIANA®. Our non-acne dermatological product lines include DYSPORT®,
LOPROX®, PERLANE®, RESTYLANE® and VANOS®. Our
non-dermatological product lines include AMMONUL®, BUPHENYL® and the
LIPOSONIXTM system. Our non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generic agreements.
Financial Information About Segments
We operate in one business segment: pharmaceuticals. Our current pharmaceutical franchises
are divided between the dermatological and non-dermatological fields. Information on revenues,
operating income, identifiable assets and supplemental revenue of our business franchises appears
in the condensed consolidated financial statements included in Item 1 hereof.
Key Aspects of Our Business
We derive a majority of our revenue from our primary products: DYSPORT®,
PERLANE®, RESTYLANE®, SOLODYN®, TRIAZ®,
VANOS® and ZIANA®. We believe that sales of our primary products will
constitute a significant portion of our revenue for 2010.
We have built our business by executing a four-part growth strategy: promoting existing
brands, developing new products and important product line extensions, entering into strategic
collaborations and acquiring complementary products, technologies and businesses. Our core
philosophy is to cultivate high integrity relationships of trust and confidence with the foremost
dermatologists and the leading plastic surgeons in the U.S. We rely on third parties to
manufacture our products (except for the LIPOSONIXTM system).
We estimate customer demand for our prescription products primarily through use of third party
syndicated data sources which track prescriptions written by health care providers and dispensed by
licensed pharmacies. The data represents extrapolations from information provided only by certain
pharmacies and are estimates of historical demand levels. We estimate customer demand for our
non-prescription products primarily through internal data that we compile. We observe trends from
these data and, coupled with certain proprietary information, prepare demand forecasts that are the
basis for purchase orders for finished and component inventory from our third party manufacturers
and suppliers. Our forecasts may fail to accurately anticipate ultimate customer demand for our
products. Overestimates of demand and sudden changes in market conditions may result in excessive
inventory production and underestimates may result in inadequate supply of our products in channels
of distribution.
We schedule our inventory purchases to meet anticipated customer demand. As a result,
miscalculation of customer demand or relatively small delays in our receipt of manufactured
products could result in revenues being deferred or lost. Our operating expenses are based upon
anticipated sales levels, and a high percentage of our operating expenses are relatively fixed in
the short term.
We sell our products primarily to major wholesalers and retail pharmacy chains. Approximately
65-75% of our gross revenues are typically derived from two major drug wholesale concerns.
Depending on the customer, we
29
recognize revenue at the time of shipment to the customer, or at the time of receipt by the
customer, net of estimated provisions. As a result of certain amendments made to our distribution
services agreement with McKesson, our exclusive U.S. distributor of our aesthetics products
DYSPORT®, PERLANE® and RESTYLANE®, we began recognizing revenue on
these products upon the shipment from McKesson to physicians beginning in the second quarter of
2009. Consequently, variations in the timing of revenue recognition could cause significant
fluctuations in operating results from period to period and may result in unanticipated periodic
earnings shortfalls or losses. We have distribution services agreements with our two largest
wholesale customers. We review the supply levels of our significant products sold to major
wholesalers by reviewing periodic inventory reports that are supplied to us by our major
wholesalers in accordance with the distribution services agreements. We rely wholly upon our
wholesale and drug chain customers to effect the distribution allocation of substantially all of
our prescription products. We believe our estimates of trade inventory levels of our products,
based on our review of the periodic inventory reports supplied by our major wholesalers and the
estimated demand for our products based on prescription and other data, are reasonable. We further
believe that inventories of our products among wholesale customers, taken as a whole, are similar
to those of other specialty pharmaceutical companies, and that our trade practices, which
periodically involve volume discounts and early payment discounts, are typical of the industry.
We periodically offer promotions to wholesale and chain drugstore customers to encourage
dispensing of our prescription products, consistent with prescriptions written by licensed health
care providers. Because many of our prescription products compete in multi-source markets, it is
important for us to ensure the licensed health care providers dispensing instructions are
fulfilled with our branded products and are not substituted with a generic product or another
therapeutic alternative product which may be contrary to the licensed health care providers
recommended and prescribed Medicis brand. We believe that a critical component of our brand
protection program is maintenance of full product availability at drugstore and wholesale
customers. We believe such availability reduces the probability of local and regional product
substitutions, shortages and backorders, which could result in lost sales. We expect to continue
providing favorable terms to wholesale and retail drug chain customers as may be necessary to
ensure the fullest possible distribution of our branded products within the pharmaceutical chain of
commerce. From time to time we may enter into business arrangements (e.g., loans or investments)
involving our customers and those arrangements may be reviewed by federal and state regulators.
Purchases by any given customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same period, resulting in fluctuations of
product inventory in the distribution channel.
Recent Developments
As described in more detail below, the following significant events and transactions occurred
during the six months ended June 30, 2010, and affected our results of operations, our cash flows
and our financial condition:
|
|
|
-
|
|
FDA approval of RESTYLANE-LTM and PERLANE-LTM; |
|
|
|
-
|
|
Increase of our quarterly dividend from $0.04 per share to $0.06 per share; |
|
|
|
-
|
|
Notice of Allowance received from the USPTO for a patent application related to SOLODYN®; and |
|
|
|
-
|
|
Reexamination Certificate received from the USPTO related to SOLODYN®. |
FDA approval of RESTYLANE-LTM and PERLANE-LTM
On January 29, 2010, the FDA approved our dermal fillers RESTYLANE-LTM and
PERLANE-LTM, which include the addition of 0.3% lidocaine. RESTYLANE-LTM is
approved for implantation into the mid to deep dermis, and PERLANE-LTM is approved for
implantation into the deep dermis to superficial subcutis, both for the correction of moderate to
severe facial wrinkles and folds, such as nasolabial folds. We began shipping
RESTYLANE-LTM and PERLANE-LTM during February 2010.
Increase of our quarterly dividend from $0.04 per share to $0.06 per share
On March 10, 2010, we announced that our Board of Directors had declared a cash dividend of
$0.06 per issued and outstanding share of our Class A common stock, payable on April 30, 2010, to
stockholders of record at the close of business on April 1, 2010. This represented a 50% increase
compared to our previous $0.04 dividend. On June 9, 2010, we announced that our Board of Directors
had declared a cash dividend of $0.06 per issued and
30
outstanding share of our Class A common stock payable on July 30, 2010, to our stockholders of
record at the close of business on July 1, 2010.
Notice of Allowance received from the USPTO related to SOLODYN®
On April 2, 2010, we received a second Notice of Allowance from the U.S. Patent and Trademark
Office (USPTO) for our U.S. patent application No. 11/166,817, entitled Method For The Treatment
Of Acne (the 817 Application). The USPTO initially issued a Notice of Allowance for the 817
Application in October 2009; however, we filed a Request for Continued Examination with the USPTO
in the 817 Application in November 2009 so that the USPTO could consider references filed in the
Reexamination of our U.S. Patent No. 5,908,838. The newly allowed claims under the 817
Application cover methods of using a controlled-release oral dosage form of minocycline to treat
acne, including the use of our product SOLODYN® (minocycline HCl, USP) Extended Release
Tablets in all five currently available dosage forms.
Reexamination Certificate received from the USPTO related to SOLODYN®
On June 1, 2010, we received a Reexamination Certificate issued by the USPTO in connection
with the USPTOs reexamination of U.S. Patent No. 5,908,838 related to our acne medication
SOLODYN®. The Reexamination Certificate is directed to patentable claims 3,
4, 12, and 13, as well as new claims 19-34. The USPTO determined that the claims are patentable,
including over all the cited prior art. The claims are the subject of patent infringement lawsuits
filed by the Company in Maryland.
Subsequent Event
On July 20, 2010, we received a Notice of Allowance issued by the USPTO for our U.S. patent
application directed to the use of SOLODYN ® in all five currently available
dosage forms. The patent application is U.S. Application No. 12/253,845, entitled Minocycline
Oral Dosage Forms For The Treatment of Acne. The newly allowed claims are directed to methods of
treating acne using controlled-release oral dosage forms of minocycline.
31
Results of Operations
The following table sets forth certain data as a percentage of net revenues for the periods
indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
(a) |
|
(b) |
|
(c) |
|
(d) |
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (e) |
|
|
90.5 |
|
|
|
90.7 |
|
|
|
90.5 |
|
|
|
90.7 |
|
Operating expenses |
|
|
56.7 |
|
|
|
64.9 |
|
|
|
56.3 |
|
|
|
75.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
33.8 |
|
|
|
25.8 |
|
|
|
34.2 |
|
|
|
15.0 |
|
Other income (expense), net |
|
|
|
|
|
|
1.6 |
|
|
|
(0.1 |
) |
|
|
(0.3 |
) |
Interest and investment
(expense) income, net |
|
|
(0.2 |
) |
|
|
0.8 |
|
|
|
(0.1 |
) |
|
|
1.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense |
|
|
33.6 |
|
|
|
28.2 |
|
|
|
34.0 |
|
|
|
15.8 |
|
Income tax expense |
|
|
(12.7 |
) |
|
|
(17.2 |
) |
|
|
(13.0 |
) |
|
|
(9.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
20.9 |
% |
|
|
11.0 |
% |
|
|
21.0 |
% |
|
|
6.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $2.3 million (1.3% of net revenues) of compensation
expense related to stock options, restricted stock and stock appreciation rights. |
|
(b) |
|
Included in operating expenses is $5.0 million (3.6% of net revenues) of compensation expense
related to stock options, restricted stock and stock appreciation rights and $3.0 million
(2.1% of net revenues) paid to Perrigo related to a product development agreement. |
|
(c) |
|
Included in operating expenses is $5.4 million (1.6% of net revenues) of compensation expense
related to stock options, restricted stock and stock appreciation rights. |
|
(d) |
|
Included in operating expenses is $5.0 million (2.1% of net revenues) paid to IMPAX related
to a product development agreement, $3.0 million (1.2% of net revenues) paid to Perrigo
related to a product development agreement and $8.9 million (3.7% of net revenues) of
compensation expense related to stock options, restricted stock and stock appreciation rights. |
|
(e) |
|
Gross profit does not include amortization of the related intangibles as such expense is
included in operating expenses. |
32
Three Months Ended June 30, 2010 Compared to the Three Months Ended June 30, 2009
Net Revenues
The following table sets forth our net revenues for the three months ended June 30, 2010 (the
second quarter of 2010) and June 30, 2009 (the second quarter of 2009), along with the
percentage of net revenues and percentage point change for each of our product categories (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
Second Quarter |
|
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
|
Net product revenues |
|
$ |
172.2 |
|
|
$ |
138.7 |
|
|
$ |
33.5 |
|
|
|
24.2 |
% |
Net contract revenues |
|
|
1.8 |
|
|
|
2.5 |
|
|
|
(0.7 |
) |
|
|
(28.0 |
)% |
|
|
|
Total net revenues |
|
$ |
174.0 |
|
|
$ |
141.2 |
|
|
$ |
32.8 |
|
|
|
23.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
Second Quarter |
|
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
|
Acne and acne-related
dermatological products |
|
$ |
124.7 |
|
|
$ |
94.2 |
|
|
$ |
30.5 |
|
|
|
32.4 |
% |
Non-acne dermatological
products |
|
|
41.0 |
|
|
|
37.1 |
|
|
|
3.9 |
|
|
|
10.5 |
% |
Non-dermatological products
(including contract revenues) |
|
|
8.3 |
|
|
|
9.9 |
|
|
|
(1.6 |
) |
|
|
(16.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
174.0 |
|
|
$ |
141.2 |
|
|
$ |
32.8 |
|
|
|
23.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
Second Quarter |
|
|
|
|
2010 |
|
2009 |
|
Change |
|
Acne and acne-related
dermatological products |
|
|
71.7 |
% |
|
|
66.7 |
% |
|
|
5.0 |
% |
Non-acne dermatological
products |
|
|
23.6 |
% |
|
|
26.3 |
% |
|
|
(2.7 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
4.7 |
% |
|
|
7.0 |
% |
|
|
(2.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
Net revenues associated with our acne and acne-related dermatological products increased by
$30.5 million, or 32.4%, during the second quarter of 2010 as compared to the second quarter of
2009 primarily as a result of increased sales of SOLODYN® and ZIANA®, both of
which were generated by strong prescription growth. In addition, during the third quarter of 2009
we launched new 65mg and 115mg strengths of SOLODYN® after they were approved by the
FDA.
Net revenues associated with our non-acne dermatological products increased by $3.9 million,
or 10.5% during the second quarter of 2010 as compared to the second quarter of 2009, primarily due
to increased sales of DYSPORT®, which was launched in June 2009, and increased sales of
RESTYLANE®, partially offset by a decrease in sales of LOPROX®, which was
negatively impacted by generic competition. RESTYLANE-LTM and PERLANE-LTM
were launched during February 2010 following FDA approval on January 29, 2010. Net revenues
associated with our non-acne dermatological products decreased as a percentage of net revenues
during the second quarter of 2010 as compared to the second quarter of 2009, primarily due to the
$30.5 million increase in our acne and acne-related dermatological products.
33
Net revenues associated with our non-dermatological products decreased by $1.6 million, or
16.2%, during the second quarter of 2010 as compared to the second quarter of 2009 primarily due to
a decrease in sales of BUPHENYL® and a reduction in contract revenue.
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 second quarter of 2010 and 2009 was approximately $5.4 million and $6.2
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 second quarter of 2010 and 2009, along
with the percentage of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
Second Quarter |
|
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
|
Gross profit |
|
$ |
157.5 |
|
|
$ |
128.2 |
|
|
$ |
29.3 |
|
|
|
22.9 |
% |
% of net revenues |
|
|
90.5 |
% |
|
|
90.7 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the second quarter of 2010 as compared to the second
quarter of 2009 is primarily due to the $32.8 million increase in net revenues. Gross profit as a
percentage of net revenues was 90.5% during the second quarter of 2010, as compared to 90.7% during
the second quarter of 2009. Net revenues of SOLODYN®, a high gross margin product,
increased during the second quarter of 2010 as compared to the second quarter of 2009, while net
revenues of other products, which have lower gross margins, also increased.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the second
quarter of 2010 and 2009, along with the percentage of net revenues represented by selling, general
and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
Second Quarter |
|
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
|
Selling, general and administrative |
|
$ |
80.9 |
|
|
$ |
71.7 |
|
|
$ |
9.2 |
|
|
|
12.8 |
% |
% of net revenues |
|
|
46.5 |
% |
|
|
50.7 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
2.2 |
|
|
$ |
4.8 |
|
|
$ |
(2.6 |
) |
|
|
(54.2 |
)% |
Selling, general and administrative expenses increased $9.2 million, or 12.8%, during the
second quarter of 2010 as compared to the second quarter of 2009, but decreased as a percentage of
net revenues from 50.7% during the second quarter of 2009 to 46.5% during the second quarter of
2010. Included in this increase was a $5.2 million increase in personnel expenses, primarily due
to $2.9 million of severance expense related to the departure of an executive employee, and an
increase of $4.0 million of other selling, general and administrative costs. The decrease of
selling, general and administrative expenses as a percentage of net revenues during the second
quarter of 2010 as compared to the second quarter of 2009 was primarily due to the $32.8 million
increase in net revenues.
34
Research and Development Expenses
The following table sets forth our research and development expenses for the second quarter of
2010 and 2009 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
% Change |
|
Research and development |
|
$ |
10.5 |
|
|
$ |
12.1 |
|
|
$ |
(1.6 |
) |
|
|
(13.2) |
% |
Charges included in
research
and development |
|
$ |
|
|
|
$ |
3.0 |
|
|
$ |
(3.0 |
) |
|
|
(100.0) |
% |
Share-based compensation
expense included in
research and development |
|
$ |
0.1 |
|
|
$ |
0.2 |
|
|
$ |
(0.1 |
) |
|
|
(50.0) |
% |
Included in research and development expenses for the second quarter of 2009 was a $3.0
million payment to Perrigo related to a development agreement. We expect research and development
expenses to continue to fluctuate from quarter to quarter based on the timing of the achievement of
development milestones under license and development agreements, as well as the timing of other
development projects and the funds available to support these projects.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the second quarter of 2010 were $7.2 million, as
compared to $7.9 million during the second quarter of 2009. The decrease was primarily due
amortization expense related to intangible assets related to Medicis Pediatrics, Inc., which was
sold to BioMarin Pharmaceutical Inc. during the second quarter of 2009, not being incurred during
the second quarter of 2010.
Interest and Investment Income
Interest and investment income during the second quarter of 2010 decreased $1.4 million, or
63.9%, to $0.8 million from $2.2 million during the second quarter of 2009, due to a decrease in
the interest rates achieved by our invested funds during the second quarter of 2010.
Interest Expense
Interest expense during the second quarter of 2010 and the second quarter of 2009 was $1.1
million. Our interest expense during the second quarter of 2010 and 2009 consisted of interest
expense on our Old Notes, which accrue interest at 2.5% per annum, and our New Notes, which accrue
interest at 1.5% per annum. See Note 11 in our accompanying condensed consolidated financial
statements for further discussion on the Old Notes and New Notes.
Other Income, net
Other income, net, of $2.2 million recognized during the second quarter of 2009 primarily
represented the $2.2 million gain on the sale of Medicis Pediatrics to BioMarin that closed during
June 2009.
Income Tax Expense
Our effective tax rate for the second quarter of 2010 was 37.7%, as compared to 60.9% for the
second quarter of 2009. The effective tax rate for the second quarter of 2009 reflects a $9.0
million discrete tax expense due to the taxable gain on the sale of Medicis Pediatrics. Excluding
this discrete tax expense (and the associated accounting gain of $2.2 million), the effective tax
rate for the second quarter of 2009 was 40.5%.
35
Six Months Ended June 30, 2010 Compared to the Six Months Ended June 30, 2009
Net Revenues
The following table sets forth our net revenues for the six months ended June 30, 2010 (the
2010 six months) and June 30, 2009 (the 2009 six months), along with the percentage of net
revenues and percentage point change for each of our product categories (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
|
Net product revenues |
|
$ |
336.7 |
|
|
$ |
235.3 |
|
|
$ |
101.4 |
|
|
|
43.1 |
% |
Net contract revenues |
|
|
3.8 |
|
|
|
5.8 |
|
|
|
(2.0 |
) |
|
|
(34.5 |
)% |
|
|
|
Total net revenues |
|
$ |
340.5 |
|
|
$ |
241.1 |
|
|
$ |
99.4 |
|
|
|
41.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
|
Acne and acne-related
dermatological products |
|
$ |
245.0 |
|
|
$ |
160.6 |
|
|
$ |
84.4 |
|
|
|
52.6 |
% |
Non-acne dermatological
products |
|
|
75.2 |
|
|
|
60.6 |
|
|
|
14.6 |
|
|
|
24.1 |
% |
Non-dermatological products
(including contract revenues) |
|
|
20.3 |
|
|
|
19.9 |
|
|
|
0.4 |
|
|
|
2.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
340.5 |
|
|
$ |
241.1 |
|
|
$ |
99.4 |
|
|
|
41.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
Months |
|
Months |
|
Change |
|
Acne and acne-related
dermatological products |
|
|
71.9 |
% |
|
|
66.7 |
% |
|
|
5.2 |
% |
Non-acne dermatological
products |
|
|
22.1 |
% |
|
|
25.1 |
% |
|
|
(3.0 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
6.0 |
% |
|
|
8.2 |
% |
|
|
(2.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
% |
|
|
|
Net revenues associated with our acne and acne-related dermatological products increased by
$84.4 million, or 52.6%, during the 2010 six months as compared to the 2009 six months primarily as
a result of increased sales of SOLODYN® and ZIANA®, both of which generated
strong prescription growth. Net revenues of SOLODYN® during the 2009 six months were
negatively impacted by the unauthorized one-day launch of Tevas generic SOLODYN®
product units that were sold into the distribution channel prior to the consummation of a
Settlement Agreement with us on March 18, 2009. These units caused wholesalers to reduce ordering
levels of SOLODYN® and caused us to increase our reserves for sales returns and consumer
rebates during the first quarter of 2009. In addition, during the third quarter of 2009 we
launched new 65mg and 115mg strengths of SOLODYN® after they were approved by the FDA.
Net revenues associated with our non-acne dermatological products increased by $14.6 million,
or 24.1% during the 2010 six months as compared to the 2009 six months, primarily due to sales of
DYSPORT®, which was launched in June 2009, and increased sales of RESTYLANE®.
RESTYLANE-LTM and PERLANE-LTM were launched during February 2010 following
FDA approval on January 29, 2010. Net revenues associated with our non-acne dermatological
products decreased as a percentage of net revenues during the 2010 six months as
36
compared to the 2009 six months, primarily due to the $84.4 million increase in our acne and
acne-related dermatological products. Beginning in the second quarter of 2009, as a result of
certain modifications made to our distribution services agreement with McKesson, our exclusive U.S.
distributor of our aesthetics products RESTYLANE®, PERLANE® and
DYSPORT®, we began recognizing revenue on these products upon the shipment from McKesson
to physicians. As a result, aesthetic product net revenues were negatively impacted
during the first quarter of 2009 in anticipation of this change in revenue recognition.
Net revenues associated with our non-dermatological products increased by $0.4 million, or
2.0%, during the 2010 six months as compared to the 2009 six months primarily due to an increase in
sales of BUPHENYL®.
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 2010 six months and 2009 six months was approximately $10.7 million and $11.7
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 2010 six months and 2009 six months,
along with the percentage of net revenues represented by such gross profit (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
|
Gross profit |
|
$ |
308.3 |
|
|
$ |
218.6 |
|
|
$ |
89.7 |
|
|
|
41.0 |
% |
% of net revenues |
|
|
90.5 |
% |
|
|
90.7 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the 2010 six months as compared to the 2009 six months is
primarily due to the $99.4 million increase in net revenues. Gross profit as a percentage of net
revenues was 90.5% during the 2010 six months, as compared to 90.7% during 2009 six months. Net
revenues of SOLODYN®, a high gross margin product, increased during the 2010 six months
as compared to the 2009 six months, while net revenues of other products, which have lower gross
margins, also increased.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the 2010
six months and 2009 six months, along with the percentage of net revenues represented by selling,
general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
|
Selling, general and administrative |
|
$ |
156.8 |
|
|
$ |
142.1 |
|
|
$ |
14.7 |
|
|
|
10.3 |
% |
% of net revenues |
|
|
46.1 |
% |
|
|
58.9 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative expense |
|
$ |
5.2 |
|
|
$ |
8.5 |
|
|
$ |
(3.3 |
) |
|
|
(38.8 |
)% |
Selling, general and administrative expenses increased $14.7 million, or 10.3%, during the
2010 six months as compared to the 2009 six months, but decreased as a percentage of net revenues
from 58.9% during the 2009 six months to 46.1% during the 2010 six months. Included in this
increase was a $6.5 million increase in personnel costs, primarily due to the effect of the annual
salary increase that occurred during February 2010 and $2.9 million of severance expense related to
the departure of an executive employee, a $4.9 million increase in promotion expenses, primarily
related to the promotion of DYSPORT® and an increase of $3.3 million of other selling,
general and administrative costs. The decrease of selling, general and administrative expenses as
a percentage of net revenues during the 2010 six months as compared to the 2009 six months was
primarily due to the $99.4 million increase in net revenues.
37
Research and Development Expenses
The following table sets forth our research and development expenses for the 2010 six months
and 2009 six months (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
|
Research and development |
|
$ |
20.7 |
|
|
$ |
25.3 |
|
|
$ |
(4.6 |
) |
|
|
(18.2) |
% |
Charges included in
research
and development |
|
$ |
|
|
|
$ |
8.0 |
|
|
$ |
(8.0 |
) |
|
|
(100.0) |
% |
Share-based compensation
expense included in
research and development |
|
$ |
0.2 |
|
|
$ |
0.4 |
|
|
$ |
(0.2 |
) |
|
|
(50.0) |
% |
Included in research and development expenses for the 2009 six months was a $5.0 million
milestone payment to Impax related to a development agreement and a $3.0 million payment to Perrigo
related to a development agreement. We expect research and development expenses to continue to
fluctuate from quarter to quarter based on the timing of the achievement of development milestones
under license and development agreements, as well as the timing of other development projects and
the funds available to support these projects.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the 2010 six months were $14.3 million, as
compared to $15.1 million during the 2009 six months. An increase related to amortization of the
$75.0 million milestone payment made to Ipsen during the second quarter of 2009 upon the FDAs
approval of DYSPORT®, which was capitalized as an intangible asset, was offset by the
amortization expense related to intangible assets related to Medicis Pediatrics, Inc., which was
sold to BioMarin Pharmaceutical Inc. during the second quarter of 2009, not being incurred during
the 2010 six months.
Interest and Investment Income
Interest and investment income during the 2010 six months decreased $2.7 million, or 58.2%, to
$1.9 million from $4.6 million during the 2009 six months, due to a decrease in the interest rates
achieved by our invested funds during the 2010 six months.
Interest Expense
Interest expense during the 2010 six months and the 2009 six months was $2.1 million. Our
interest expense during the 2010 six months and 2009 six months consisted of interest expense on
our Old Notes, which accrue interest at 2.5% per annum, and our New Notes, which accrue interest at
1.5% per annum. See Note 11 in our accompanying condensed consolidated financial statements for
further discussion on the Old Notes and New Notes.
Other Expense, net
Other expense of $0.3 million recognized during the 2010 six months represented an
other-than-temporary impairment on an asset-backed security investment.
Other expense, net, of $0.6 million recognized during the 2009 six months 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, partially offset by a $2.2 million gain on
the sale of Medicis Pediatrics to BioMarin, which closed during June 2009.
38
Income Tax Expense
Our effective tax rate for the 2010 six months was 38.1%, as compared to 58.0% for the 2009
six months. The effective tax rate for the 2009 six months reflects a $1.4 million discrete tax
benefit recognized due to statute closures and a $9.0 million discrete tax expense due to the
taxable gain on the sale of Medicis Pediatrics. Excluding this discrete tax benefit and this
discrete tax expense (and the associated accounting gain of $2.2 million), the effective tax rate
for the 2009 six months was 40.5%.
39
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the 2010 six months and 2009
six months, and selected balance sheet components as of June 30, 2010 and December 31, 2009 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
59.1 |
|
|
$ |
51.0 |
|
|
$ |
8.1 |
|
|
|
15.9 |
% |
Investing activities |
|
|
(166.4 |
) |
|
|
(5.8 |
) |
|
|
(160.6 |
) |
|
|
2,769.0 |
% |
Financing activities |
|
|
(3.5 |
) |
|
|
2.3 |
|
|
|
(5.8 |
) |
|
|
(252.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
Dec. 31, 2009 |
|
$ Change |
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
543.5 |
|
|
$ |
528.3 |
|
|
$ |
15.2 |
|
|
|
2.9 |
% |
Working capital |
|
|
488.5 |
|
|
|
434.6 |
|
|
|
53.9 |
|
|
|
12.4 |
% |
Long-term investments |
|
|
61.0 |
|
|
|
25.5 |
|
|
|
35.5 |
|
|
|
139.2 |
% |
2.5% contingent convertible
senior notes due 2032 |
|
|
169.1 |
|
|
|
169.1 |
|
|
|
|
|
|
|
|
% |
1.5% contingent convertible
senior notes due 2033 |
|
|
0.2 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
% |
Working Capital
Working capital as of June 30, 2010 and December 31, 2009, consisted of the following (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2010 |
|
Dec. 31, 2009 |
|
$ Change |
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
543.5 |
|
|
$ |
528.3 |
|
|
$ |
15.2 |
|
|
|
2.9 |
% |
Accounts receivable, net |
|
|
136.9 |
|
|
|
95.2 |
|
|
|
41.7 |
|
|
|
43.8 |
% |
Inventories, net |
|
|
37.2 |
|
|
|
26.0 |
|
|
|
11.2 |
|
|
|
43.1 |
% |
Deferred tax assets, net |
|
|
67.3 |
|
|
|
66.3 |
|
|
|
1.0 |
|
|
|
1.5 |
% |
Other current assets |
|
|
20.4 |
|
|
|
16.5 |
|
|
|
3.9 |
|
|
|
23.6 |
% |
|
|
|
Total current assets |
|
|
805.3 |
|
|
|
732.3 |
|
|
|
73.0 |
|
|
|
10.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
58.6 |
|
|
|
44.2 |
|
|
|
14.4 |
|
|
|
32.6 |
% |
Reserve for sales returns |
|
|
49.2 |
|
|
|
48.1 |
|
|
|
1.1 |
|
|
|
2.3 |
% |
Accrued consumer rebate and
loyalty programs |
|
|
90.4 |
|
|
|
73.3 |
|
|
|
17.1 |
|
|
|
23.3 |
% |
Managed care and Medicaid
reserves |
|
|
44.4 |
|
|
|
47.1 |
|
|
|
(2.7 |
) |
|
|
(5.7 |
)% |
Income taxes payable |
|
|
2.7 |
|
|
|
16.7 |
|
|
|
(14.0 |
) |
|
|
(83.8 |
)% |
Other current liabilities |
|
|
71.5 |
|
|
|
68.3 |
|
|
|
3.2 |
|
|
|
4.7 |
% |
|
|
|
Total current liabilities |
|
|
316.8 |
|
|
|
297.7 |
|
|
|
19.1 |
|
|
|
6.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
488.5 |
|
|
$ |
434.6 |
|
|
$ |
53.9 |
|
|
|
12.4 |
% |
|
|
|
|
|
|
|
40
We had cash, cash equivalents and short-term investments of $543.5 million and working capital
of $488.5 million at June 30, 2010, as compared to $528.3 million and $434.6 million, respectively,
at December 31, 2009. The increases were primarily due to the generation of $59.1 million of
operating cash flow during the 2010 six months.
Management believes existing cash and short-term investments, together with funds generated
from operations, should be sufficient to meet operating requirements for the foreseeable future.
Our cash and short-term investments are available for dividends, milestone payments related to our
product development collaborations, strategic investments, acquisitions of companies or products
complementary to our business, the repayment of outstanding indebtedness, repurchases of our
outstanding securities and other potential large-scale needs. In addition, we may consider
incurring additional indebtedness and issuing additional debt or equity securities in the future to
fund potential acquisitions or investments, to refinance existing debt or for general corporate
purposes. If a material acquisition or investment is completed, our operating results and
financial condition could change materially in future periods. However, no assurance can be given
that additional funds will be available on satisfactory terms, or at all, to fund such activities.
On July 1, 2008, we acquired LipoSonix, an independent, privately-held company with a staff of
approximately 40 scientists, engineers and clinicians located near Seattle, Washington.
LipoSonix, now known as Medicis Technologies Corporation, is a medical device company developing
non-invasive body sculpting technology. Its first product, the LIPOSONIXTM system, is
currently marketed and sold through distributors in Europe and Canada. On June 15, 2009, Medicis
Aesthetics Canada, Ltd. announced that Health Canada had issued a Medical Device License
authorizing the sale of the LIPOSONIXTM system in Canada. In the U.S., the
LIPOSONIXTM system is an investigational device and is not currently cleared or approved
for sale. Under terms of the transaction, we paid $150 million in cash for all of the outstanding
shares of LipoSonix. In addition, we will pay LipoSonix stockholders certain milestone payments up
to an additional $150 million upon FDA approval of the LIPOSONIXTM system and if various
commercial milestones are achieved on a worldwide basis.
As of June 30, 2010, our short-term investments included $24.2 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. During the first six months
of 2010, we liquidated $3.3 million of our auction rate floating securities at par.
Operating Activities
Net cash provided by operating activities during the 2010 six months was approximately $59.1
million, compared to cash provided by operating activities of approximately $51.0 million during
the 2009 six months. The following is a summary of the primary components of cash provided by
operating activities during the 2010 six months and 2009 six months (in millions):
|
|
|
|
|
|
|
|
|
|
|
2010 Six |
|
2009 Six |
|
|
Months |
|
Months |
|
Income taxes paid |
|
|
(47.7 |
) |
|
|
(3.6 |
) |
Payment made to IMPAX related to development agreement |
|
|
|
|
|
|
(5.0 |
) |
Payment made to Perrigo related to development agreement |
|
|
|
|
|
|
(3.0 |
) |
Other cash provided by operating activities |
|
|
106.8 |
|
|
|
62.6 |
|
|
|
|
Cash provided by operating activities |
|
$ |
59.1 |
|
|
$ |
51.0 |
|
|
|
|
Investing Activities
Net cash used in investing activities during the 2010 six months was approximately $166.4
million, compared to net cash used in investing activities during the 2009 six months of $5.8
million. The change was primarily due to the net purchases and sales of our short-term and
long-term investments during the respective
41
quarters. During the 2009 six months, we paid $75.0 million to Ipsen upon the FDAs approval of
DYSPORT®, and we received $70.3 million upon the sale of Medicis Pediatrics to BioMarin,
which closed in June 2009.
Financing Activities
Net cash used in financing activities during the 2010 six months was $3.5 million, compared to
net cash provided by financing activities of $2.3 million during the 2009 six months. Proceeds
from the exercise of stock options were $2.2 million during the 2010 six months compared to $6.8
million during the 2009 six months. Dividends paid during the 2010 six months were $6.0 million,
and dividends paid during the 2009 six months were $4.7 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 $8.0 million of long-term liabilities at
June 30, 2010, and we had $316.8 million of current liabilities at June 30, 2010. Our other
commitments and planned expenditures consist principally of payments we will make in connection
with strategic collaborations and research and development expenditures, and we will continue to
invest in sales and marketing infrastructure.
In connection with occupancy of the new headquarter office during 2008, we ceased use of the
prior headquarter office, which consists of approximately 75,000 square feet of office space, at an
average annual expense of approximately $2.1 million, under an amended lease agreement that expires
in December 2010. Under ASC 420, Exit or Disposal Cost Obligations, a liability for the costs
associated with an exit or disposal activity is recognized when the liability is incurred. We
recorded lease exit costs of approximately $4.8 million during the three months ended September 30,
2008 consisting of the initial liability of $4.7 million and accretion expense of $0.1 million. We
have not recorded any other costs related to the lease for the prior headquarters.
As of June 30, 2010, approximately $1.1 million of lease exit costs remain accrued and are
expected to be paid by December 2010, all of which is classified in other current liabilities.
Although we no longer use the facilities, the lease exit cost accrual has not been offset by an
adjustment for estimated sublease rentals. After considering sublease market information as well
as factors specific to the lease, we concluded it was probable we would be unable to reasonably
obtain sublease rentals for the prior headquarters and therefore we would not be subleased for the
remaining lease term. We will continue to monitor the sublease market conditions and reassess the
impact on the lease exit cost accrual.
The following is a summary of the activity in the liability for lease exit costs for the six
months ended June 30, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2009 |
|
to Expense |
|
Made |
|
from Sublease |
|
June 30, 2010 |
Lease exit costs
liability |
|
$ |
2,063,677 |
|
|
$ |
58,664 |
|
|
$ |
(1,069,056 |
) |
|
$ |
|
|
|
$ |
1,053,285 |
|
42
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $52.6 million on our common stock. In addition, on June 9, 2010, we
announced that our Board of Directors had declared a cash dividend of $0.06 per issued and
outstanding share of common stock payable on July 30, 2010, to our stockholders of record at the
close of business on July 1, 2010. 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 $24.2 million at June 30, 2010. These securities were
included in long-term investments at June 30, 2010. We also utilize unobservable (Level 3) inputs
to value our investment in Hyperion Therapeutics, Inc.
Our auction rate floating securities are classified as available-for-sale securities or
trading securities and are reflected at fair value. In prior periods, due to the auction process
which took place every 30-35 days for most securities, quoted market prices were readily available,
which would qualify as Level 1 under ASC 820, Fair Value Measurements and Disclosure. However, due
to events in credit markets that began during the first quarter of 2008, the auction events for
most of these instruments failed, and, therefore, we determined the estimated fair values of these
securities, beginning in the first quarter of 2008, utilizing a discounted cash flow analysis.
These analyses consider, among other items, the collateralization underlying the security
investments, the expected future cash flows, including the final maturity, associated with the
securities, and the expectation of the next time the security is expected to have a successful
auction. These securities were also compared, when possible, to other observable market data with
similar characteristics to the securities held by us. Due to these events, we reclassified these
instruments as Level 3 during the first quarter of 2008.
In November 2008, we entered into a settlement agreement with the broker through which we
purchased auction rate floating securities. The settlement agreement provides us with the right to
put an auction rate floating security currently held by us back to the broker beginning on June 30,
2010. At June 30, 2010 and December 31, 2009, we held one auction rate floating security with a
par value of $1.3 million that was subject to the settlement agreement. We elected the irrevocable
Fair Value Option treatment under ASC 825, Financial Instruments, and adjusted the put option to
fair value. We reclassified this auction rate floating security from available-for-sale to trading
securities as of December 31, 2008, and future changes in fair value related to this investment and
the related put right will be recorded in earnings. This auction rate floating security was
settled at par on July 1, 2010.
Off-Balance Sheet Arrangements
As of June 30, 2010, we are not involved in any off-balance sheet arrangements, as defined in
Item 3(a)(4)(ii) of Securities and Exchange Commission (SEC) Regulation S-K.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based
upon our condensed consolidated financial statements, which have been prepared in conformity with
U.S. generally accepted accounting principles. The preparation of the condensed consolidated
financial statements requires us to make estimates and assumptions that affect the amounts reported
in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, we
evaluate our estimates related to sales allowances, chargebacks, rebates, returns and other pricing
adjustments, depreciation and amortization and other contingencies and litigation. We base our
estimates on historical experience and various other factors related to each circumstance. Actual
results could differ from those estimates based upon future events, which could include, among
other risks, changes in the regulations governing the manner in which we sell our products, changes
in the health care environment and managed care consumption patterns. Our significant accounting
policies are described in Note 2 to the consolidated financial statements included in our Form 10-K
for the year ended December 31, 2009. There were no new significant accounting estimates in the
second quarter of 2010, nor were there any material changes to the critical accounting policies and
estimates discussed in our Form 10-K for the year ended December 31, 2009.
43
Recent Accounting Pronouncements
In October 2009, the FASB approved for issuance Accounting Standards Update (ASU) No.
2009-13, Revenue Recognition (ASC 605) Multiple Deliverable Revenue Arrangements, a consensus
of EITF 08-01, Revenue Arrangements with Multiple Deliverables. This guidance modifies the fair
value requirements of ASC subtopic 605-25 Revenue Recognition Multiple Element Arrangements by
providing principles for allocation of consideration among its multiple-elements, allowing more
flexibility in identifying and accounting for separate deliverables under an arrangement. An
estimated selling price method is introduced for valuing the elements of a bundled arrangement if
vendor-specific objective evidence or third-party evidence of selling price is not available, and
significantly expands related disclosure requirements. This updated guidance is effective on a
prospective basis for revenue arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and
early application is permitted. We are currently assessing what impact, if any, the updated
guidance will have on our results of operations and financial condition.
In March 2010, the FASB approved for issuance ASU No. 2010-17, Revenue Recognition-Milestone
Method (Topic 605): Milestone Method of Revenue Recognition. The updated guidance recognizes the
milestone method as an acceptable revenue recognition method for substantive milestones in research
or development transactions, and is effective on a prospective basis for milestones achieved in
fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early
adoption is permitted. We are currently assessing what impact, if any, the updated guidance will
have on our 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:
|
|
competitive developments affecting our products, such as the FDA approvals of
Prevelle® Silk, Radiesse®, Sculptra®, Artefill®,
Hydrelle, Juvéderm® Ultra and Juvéderm® Ultra Plus,
competitors to RESTYLANE® and PERLANE®, VELTINTM, a
competitor to ZIANA®, a generic form of our DYNACIN® Tablets product,
generic forms of our LOPROX® TS, LOPROX® Cream, LOPROX® Gel
and LOPROX® Shampoo products, and potential generic forms of our TRIAZ®,
PLEXION®, SOLODYN® or VANOS® products; |
|
|
increases or decreases in the expected costs to be incurred in connection with the research
and development, clinical trials, regulatory approvals, commercialization and marketing of our
products; |
|
|
the success of research and development activities, including the development of additional
forms of SOLODYN®, and our ability to obtain regulatory approvals; |
|
|
the speed with which regulatory authorizations and product launches may be achieved; |
|
|
changes in the FDAs position on the safety or effectiveness of our products; |
|
|
changes in our product mix; |
|
|
the anticipated size of the markets and demand for our products; |
|
|
changes in prescription levels; |
44
|
|
the impact of acquisitions, divestitures and other significant corporate transactions,
including our acquisition of LipoSonix; |
|
|
risks associated with realizing all of the anticipated benefits of our acquisition of
LipoSonix; |
|
|
the effect of economic changes generally and in hurricane-effected areas; |
|
|
manufacturing or supply interruptions; |
|
|
importation of other dermal filler or botulinum toxin products, including the unauthorized
distribution of products approved in countries neighboring the U.S.; |
|
|
changes in the prescribing or procedural practices of dermatologists, podiatrists and/or
plastic surgeons, including prescription levels; |
|
|
the ability to successfully market both new products, including DYSPORT®, and
existing products; |
|
|
difficulties or delays in manufacturing and packaging of our products, including
delays and quality control lapses of third party manufacturers and suppliers of our
products; |
|
|
the availability of product supply or changes in the cost of raw materials; |
|
|
the ability to compete against generic and other branded products; |
|
|
trends toward managed care and health care cost containment; |
|
|
inadequate protection of our intellectual property or challenges to the validity or
enforceability of our proprietary rights and our ability to secure patent protection from
filed patent applications for our primary products, including SOLODYN®; |
|
|
possible introduction of generic versions of our products, including SOLODYN®; |
|
|
possible federal and/or state legislation or regulatory action affecting, among other
things, the Companys ability to enter into agreements with companies introducing generic
versions of the Companys products as well as pharmaceutical pricing and reimbursement,
including Medicaid and Medicare and involuntary approval of prescription medicines for
over-the-counter use; |
|
|
legal defense costs, insurance expenses, settlement costs and the risk of an adverse
decision or settlement related to product liability, patent protection, government
investigations, and other legal proceedings (see Part II, Item 1, Legal Proceedings); |
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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, including
for the LIPOSONIXTM system; |
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the inability to obtain required regulatory approvals for any of our pipeline products; |
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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, 2009, and this Quarterly Report contain discussions of various risks
relating to our business that could cause actual results to differ materially from expected and
historical results, which you should review. You should understand that it is not possible to
predict or identify all such risks. Consequently, you should not consider any such list or
discussion to be a complete set of all potential risks or uncertainties.
45
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of June 30, 2010, there were no material changes to the information previously reported
under Item 7A in our Annual Report on Form 10-K for the year ended December 31, 2009.
Item 4. Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of
the Exchange Act) that are designed to ensure that information required to be disclosed in reports
filed by us under the Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms and that such information is accumulated and
communicated to management, including our Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow for timely decisions regarding required disclosure. Our Chief Executive
Officer and Chief Financial Officer, with the participation of other members of management,
evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2010, and have
concluded that, as of such date, our disclosure controls and procedures were effective to ensure
that the information we are required to disclose in reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the SECs rules and forms.
Although the management of the Company, including the Chief Executive Officer and the Chief
Financial Officer, believes that our disclosure controls and internal controls currently provide
reasonable assurance that our desired control objectives have been met, management does not expect
that our disclosure controls or internal controls will prevent all errors and all fraud. A control
system, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent limitations in all control systems,
no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty, and that breakdowns can occur because of
simple error or mistake. Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the controls. The design
of any system of controls is also based in part upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions.
During the three months ended June 30, 2010, there was no change in our internal control over
financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
46
Part II. Other Information
Item 1. Legal Proceedings
The information set forth under Note 16 in our accompanying condensed consolidated financial
statements, included in Part I, Item I of this Report, is incorporated herein by reference.
Item 1A. Risk Factors
We operate in a rapidly changing environment that involves a number of risks that could
materially and adversely affect our business, financial condition, prospects, operating results or
cash flows. For a detailed discussion of the risk factors that should be understood by any
investor contemplating investment in our stock, please refer to Part I, Item 1A Risk Factors in
our Annual Report on Form 10-K for the year ended December 31, 2009.
There are no material changes from the risk factors previously disclosed in Part I, Item 1A
Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2009.
47
Item 6. Exhibits
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Exhibit 3.1
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Amended and Restated By-Laws of the Company(1) |
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Exhibit 10.1+*
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License and Settlement Agreement, dated May 4, 2010, among the Company, Ranbaxy Inc. and Ranbaxy Laboratories Limited. |
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Exhibit 10.2+
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Settlement Agreement and Release, dated June 15, 2010, between the Company and Joseph P. Cooper. |
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Exhibit 10.3+
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First Amendment to Amended and Restated Employment Agreement, dated June 15, 2010, between the Company and Jason D. Hanson. |
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Exhibit 10.4+
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First Amendment to Employment Agreement, dated June 15, 2010, between the Company and Richard D. Peterson. |
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Exhibit 10.5+
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First Amendment to Amended and Restated Employment Agreement, dated June 15, 2010, between the Company and Mark A. Prygocki. |
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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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Exhibit 101+**
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The following financial information
from Medicis Pharmaceutical Corporations Quarterly Report on
Form 10-Q for the quarter ended June 30, 2010, formatted in XBRL
(Extensible Business Reporting Language) includes: (i) the Condensed
Consolidated Balance Sheets as of June 30, 2010 and December 31,
2009, (ii) the Condensed Consolidated Statements of Income for each
of the three-month and six-month periods ended June 30, 2010 and
2009, (iii) the Condensed Consolidated Statements of Cash Flows for
each of the six-month periods ended June 30, 2010 and 2009, and (iv)
the Notes to the Condensed Consolidated Financial Statements. |
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+ |
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Filed herewith |
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(1) |
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Filed as Exhibit 3.1 to Form 8-K on June 18, 2010 and incorporated herein by reference. |
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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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** |
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Pursuant to applicable securities laws and regulations, we
are deemed to have complied with the reporting obligation relating to
the submission of interactive data files in such exhibits and are not
subject to liability under any anti-fraud provisions of the federal
securities laws as long as we have made a good faith attempt to
comply with the submission requirements and promptly amend the
interactive data files after becoming aware that the interactive data
files fail to comply with the submission requirements.
Users of this data are advised that, pursuant to Rule 406T, these
interactive data files are deemed not filed and otherwise are not
subject to liability.
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48
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: August 9, 2010 |
By: |
/s/ Jonah Shacknai
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Jonah Shacknai |
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Chairman of the Board and
Chief Executive Officer
(Principal Executive Officer) |
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Date: August 9, 2010 |
By: |
/s/ Richard D. Peterson
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Richard D. Peterson |
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Executive Vice
President
Chief Financial Officer and Treasurer
(Principal Financial and Accounting
Officer) |
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49