e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2007
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 0-18443
MEDICIS PHARMACEUTICAL CORPORATION
(Exact name of Registrant as specified in its charter)
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Delaware
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52-1574808 |
(State or other jurisdiction of
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(I.R.S. Employer Identification No.) |
incorporation or organization) |
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8125 North Hayden Road
Scottsdale, Arizona 85258-2463
(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 is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer þ Accelerated filer o Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule
12b-2) YES o NO þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of
the latest practicable date:
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Class |
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Shares Outstanding at August 3, 2007 |
Class A Common Stock $.014 Par Value
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56,115,791 |
MEDICIS PHARMACEUTICAL CORPORATION
Table of Contents
2
Part I. Financial Information
Item 1. Financial Statements
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
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June 30, 2007 |
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December 31, 2006 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
62,015 |
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$ |
203,319 |
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Short-term investments |
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534,500 |
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350,942 |
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Accounts receivable, net |
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36,370 |
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Inventories, net |
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30,657 |
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27,016 |
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Deferred tax assets, net |
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22,940 |
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23,047 |
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Other current assets |
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19,166 |
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15,990 |
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Total current assets |
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669,278 |
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656,684 |
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Property and equipment, net |
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9,618 |
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6,576 |
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Intangible assets: |
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Intangible assets related to product line
acquisitions and business combinations |
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260,773 |
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239,396 |
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Other intangible assets |
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6,632 |
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6,052 |
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267,405 |
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245,448 |
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Less: accumulated amortization |
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81,628 |
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76,241 |
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Net intangible assets |
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185,777 |
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169,207 |
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Goodwill |
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63,107 |
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63,107 |
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Deferred tax assets, net |
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34,356 |
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41,241 |
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Long-term investments |
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148,395 |
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130,290 |
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Deferred financing costs, net |
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1,198 |
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2,181 |
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$ |
1,111,729 |
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$ |
1,069,286 |
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See accompanying notes to condensed consolidated financial statements.
3
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
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June 30, 2007 |
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December 31, 2006 |
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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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$ |
40,514 |
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$ |
47,513 |
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Income taxes payable |
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430 |
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11,346 |
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Other current liabilities |
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57,621 |
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47,803 |
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Total current liabilities |
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98,565 |
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106,662 |
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Long-term liabilities: |
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Contingent convertible senior notes |
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453,060 |
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453,065 |
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Other liabilities |
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543 |
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Stockholders Equity |
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Preferred stock, $0.01 par value; shares
authorized: 5,000,000; no shares issued |
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Class A common stock, $0.014 par value;
shares authorized: 150,000,000; issued and
outstanding: 68,744,878 and 68,044,363 at
June 30, 2007 and December 31, 2006,
respectively |
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962 |
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952 |
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Class B common stock, $0.014 par value; shares
authorized: 1,000,000; no shares issued |
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Additional paid-in capital |
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627,728 |
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598,435 |
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Accumulated other comprehensive income |
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734 |
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537 |
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Accumulated earnings |
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273,041 |
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252,431 |
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Less: Treasury stock, 12,653,043 and 12,650,233
shares at cost at June 30, 2007 and December 31,
2006, respectively |
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(342,904 |
) |
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(342,796 |
) |
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Total stockholders equity |
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559,561 |
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509,559 |
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$ |
1,111,729 |
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$ |
1,069,286 |
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See accompanying notes to condensed consolidated financial statements.
4
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, |
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June 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Net product revenues |
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$ |
105,902 |
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$ |
80,646 |
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$ |
198,273 |
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$ |
151,733 |
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Net contract revenues |
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2,962 |
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4,386 |
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5,705 |
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8,456 |
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Net revenues |
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108,864 |
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85,032 |
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203,978 |
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160,189 |
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Cost of product revenues (1) |
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14,011 |
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9,419 |
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24,508 |
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21,598 |
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Gross profit |
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94,853 |
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75,613 |
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179,470 |
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138,591 |
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Operating expenses: |
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Selling, general and administrative (2) |
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59,894 |
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51,065 |
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122,155 |
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102,288 |
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Impairment of long-lived assets |
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4,067 |
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4,067 |
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Research and development (3) |
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7,148 |
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43,767 |
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15,154 |
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140,985 |
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Depreciation and amortization |
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5,878 |
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5,800 |
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11,332 |
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11,656 |
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Operating income (loss) |
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17,866 |
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(25,019 |
) |
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26,762 |
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(116,338 |
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Interest and investment income |
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9,251 |
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7,262 |
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18,258 |
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14,283 |
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Interest expense |
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(2,568 |
) |
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(2,658 |
) |
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(5,226 |
) |
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(5,316 |
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Income (loss) before income tax expense |
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24,549 |
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(20,415 |
) |
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39,794 |
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(107,371 |
) |
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Income tax expense (benefit) |
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9,026 |
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(35,934 |
) |
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14,983 |
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(34,347 |
) |
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Net income (loss) |
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$ |
15,523 |
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$ |
15,519 |
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$ |
24,811 |
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$ |
(73,024 |
) |
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Basic net income (loss) per share |
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$ |
0.28 |
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$ |
0.28 |
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$ |
0.44 |
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$ |
(1.34 |
) |
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Diluted net income (loss) per share |
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$ |
0.24 |
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$ |
0.25 |
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$ |
0.39 |
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$ |
(1.34 |
) |
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Cash dividend declared per common share |
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$ |
0.03 |
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$ |
0.03 |
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$ |
0.06 |
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$ |
0.06 |
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Basic common shares outstanding |
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55,936 |
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54,501 |
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55,782 |
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54,429 |
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Diluted common shares outstanding |
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71,318 |
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69,733 |
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|
71,466 |
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54,429 |
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(1) amounts exclude amortization of
intangible assets related to acquired
products |
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$ |
5,165 |
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$ |
5,075 |
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$ |
9,963 |
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$ |
10,150 |
|
(2) amounts include share-based
compensation expense |
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$ |
5,524 |
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$ |
6,835 |
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$ |
10,900 |
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$ |
13,482 |
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(3) amounts include share-based
compensation expense |
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$ |
117 |
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$ |
505 |
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$ |
255 |
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$ |
1,038 |
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See accompanying notes to condensed consolidated financial statements.
5
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
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Six Months Ended |
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June 30, 2007 |
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June 30, 2006 |
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Operating Activities: |
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Net income (loss) |
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$ |
24,811 |
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$ |
(73,024 |
) |
Adjustments to reconcile net income (loss) to
net cash provided by (used in) operating activities: |
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Depreciation and amortization |
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11,332 |
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|
11,656 |
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Amortization of deferred financing fees |
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|
982 |
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|
1,072 |
|
Impairment of long-lived assets |
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|
4,067 |
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Loss on disposal of property and equipment |
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19 |
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9 |
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Gain on sale of available-for-sale investments |
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(48 |
) |
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|
(227 |
) |
Share-based compensation expense |
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11,156 |
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|
14,521 |
|
Deferred income tax expense (benefit) |
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|
6,992 |
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(40,402 |
) |
Tax benefit from exercise of stock options and vesting of
restricted stock awards |
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|
2,387 |
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|
1,039 |
|
Excess tax benefits from share-based payment arrangements |
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(1,215 |
) |
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(563 |
) |
(Decrease) increase in provision for doubtful accounts
and returns |
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(8,564 |
) |
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|
1,618 |
|
Amortization of (discount)/premium on investments |
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(1,457 |
) |
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|
(1,452 |
) |
Changes in operating assets and liabilities: |
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Accounts receivable |
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|
54,227 |
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|
(3,247 |
) |
Inventories |
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|
(3,641 |
) |
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|
(25 |
) |
Other current assets |
|
|
(3,176 |
) |
|
|
(2,138 |
) |
Accounts payable |
|
|
(6,999 |
) |
|
|
2,784 |
|
Income taxes payable |
|
|
(11,724 |
) |
|
|
(21,723 |
) |
Other current liabilities |
|
|
(612 |
) |
|
|
9,657 |
|
Other liabilities |
|
|
543 |
|
|
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|
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|
Net cash provided by (used in) operating activities |
|
|
79,080 |
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|
|
(100,445 |
) |
|
|
|
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Investing Activities: |
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Purchase of property and equipment |
|
|
(4,330 |
) |
|
|
(723 |
) |
Payment of direct merger costs |
|
|
|
|
|
|
(27,420 |
) |
Payments for purchase of product rights |
|
|
(29,700 |
) |
|
|
(588 |
) |
Purchase of available-for-sale investments |
|
|
(446,542 |
) |
|
|
(388,865 |
) |
Sale of available-for-sale investments |
|
|
114,889 |
|
|
|
169,123 |
|
Maturity of available-for-sale investments |
|
|
131,283 |
|
|
|
121,620 |
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(234,400 |
) |
|
|
(126,853 |
) |
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
Payment of dividends |
|
|
(3,363 |
) |
|
|
(3,278 |
) |
Excess tax benefits from share-based payment arrangements |
|
|
1,215 |
|
|
|
563 |
|
Proceeds from the exercise of stock options |
|
|
15,754 |
|
|
|
5,948 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
13,606 |
|
|
|
3,233 |
|
|
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|
|
|
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|
Effect of exchange rate on cash and cash equivalents |
|
|
410 |
|
|
|
139 |
|
|
|
|
|
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|
|
|
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|
Net decrease in cash and cash equivalents |
|
|
(141,304 |
) |
|
|
(223,926 |
) |
Cash and cash equivalents at beginning of period |
|
|
203,319 |
|
|
|
446,997 |
|
|
|
|
|
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|
Cash and cash equivalents at end of period |
|
$ |
62,015 |
|
|
$ |
223,071 |
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
6
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2007
(unaudited)
1. NATURE OF BUSINESS
Medicis Pharmaceutical Corporation (Medicis or the Company) is a leading specialty
pharmaceutical company focusing primarily on the development and marketing of products in
the United States (U.S.) for the treatment of dermatological, aesthetic and podiatric
conditions. Medicis also markets products in Canada for the treatment of dermatological and
aesthetic conditions.
The Company offers a broad range of products addressing various conditions or aesthetic
improvements including facial wrinkles, acne, fungal infections, rosacea, hyperpigmentation,
photoaging, psoriasis, skin and skin-structure infections, seborrheic dermatitis and
cosmesis (improvement in the texture and appearance of skin). Medicis currently offers 18
branded products. Its primary brands are PERLANE®, RESTYLANE®,
SOLODYN®, TRIAZ®, VANOS and ZIANA.
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, 2006. The financial information is unaudited, but reflects all
adjustments, consisting only of normal recurring 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, 2006.
2. SHARE-BASED COMPENSATION
At June 30, 2007, 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. At the Companys 2007 Annual Meeting of
Stockholders held on May 22, 2007, the stockholders of the Company approved an amendment to
the 2006 Incentive Award Plan, increasing the number of shares of common stock reserved for
issuance under the plan by 2,500,000 shares. Stock option awards granted from these plans
are granted at the fair market value on the date of grant. The option awards vest over a
period determined at the time the options are granted, ranging from one to five years, and
generally have a maximum term of ten years. Certain options provide for accelerated vesting
if there is a change in control (as defined in the plans). When
options are exercised, new shares of the Companys Class A common stock are issued. Effective July 1, 2005, the
Company adopted SFAS No. 123R using the modified prospective method. Other than restricted
stock, no share-based employee compensation cost has been reflected in net income prior to
the adoption of SFAS No. 123R.
The adoption of SFAS No. 123R decreased income before income tax expense for the three
months and six months ended June 30, 2007 by approximately $5.6 million and $11.2 million,
respectively, and decreased net income for the three months and six months ended June 30,
2007 by approximately $3.3 million and $7.0 million, respectively. As a result, basic and
diluted net income per common share for the three months ended
June 30, 2007 were reduced $0.06 and $0.05, respectively, and basic and diluted net
income per common share for the six months ended June 30, 2007 were reduced $0.12 and $0.10,
respectively.
7
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, 2007, total unrecognized compensation
cost related to stock option awards, to be recognized as expense subsequent to June 30,
2007, was approximately $26.8 million and the related weighted-average period over which it
is expected to be recognized is approximately 1.9 years.
Prior to the adoption of SFAS No. 123R, the Company presented all tax benefits of
deductions resulting from the exercise of stock options as operating cash flows in the
condensed consolidated statements of cash flows. SFAS No. 123R requires the cash flows
resulting from the tax benefits resulting from tax deductions in excess of the compensation
cost recognized for those options (excess tax benefits) to be classified as financing cash
flows. Approximately $0.4 million and $1.2 million of excess tax benefits were recognized
during the three months and six months ended June 30, 2007, respectively.
A summary of stock options activity within the Companys stock-based compensation plans
and changes for the six months ended June 30, 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Balance at December 31, 2006 |
|
|
12,989,011 |
|
|
$ |
27.63 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
119,553 |
|
|
$ |
33.75 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(656,128 |
) |
|
$ |
21.21 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(154,377 |
) |
|
$ |
32.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
|
12,298,059 |
|
|
$ |
27.97 |
|
|
|
5.18 |
|
|
$ |
53,169,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during the six months ended June 30, 2007 was
$8,488,467. Options exercisable under the Companys share-based compensation plans at June
30, 2007 were 8,045,524, with an average exercise price of $25.82, an average remaining
contractual term of 4.5 years, and an aggregate intrinsic value of $44,569,348.
A summary of fully vested stock options and stock options expected to vest, based on
historical forfeiture rates, as of June 30, 2007, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Outstanding |
|
|
11,892,468 |
|
|
$ |
27.95 |
|
|
|
5.2 |
|
|
$ |
51,627,968 |
|
Exercisable |
|
|
7,820,172 |
|
|
$ |
25.81 |
|
|
|
4.5 |
|
|
$ |
43,424,843 |
|
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 |
|
Six Months Ended |
|
|
June 30, 2007 |
|
June 30, 2006 |
Expected dividend yield |
|
0.4% |
|
0.4% |
Expected stock price volatility |
|
0.35 |
|
0.36 |
Risk-free interest rate |
|
4.5% to 4.8% |
|
4.5% |
Expected life of options |
|
7 Years |
|
7 Years |
The expected dividend yield is based on expected annual dividends to be paid by the
Company as a percentage of the market value of the Companys stock as of the date of grant.
The Company determined that a blend of implied volatility and historical volatility is more
reflective of market conditions and a better indicator of expected volatility than using
purely historical volatility. The risk-free interest rate is based on the U.S.
8
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, 2007 and 2006 was $14.98 and $13.36, respectively.
The Company also grants restricted stock awards to certain employees. Restricted stock
awards are valued at the closing market value of the Companys Class A common stock on the
date of grant, and the total value of the award is expensed ratably over the service period
of the employees receiving the grants. During the six months ended June 30, 2007, 334,179
shares of restricted stock were granted to certain employees. Share-based compensation
expense related to all restricted stock awards outstanding during the three months and six
months ended June 30, 2007, was approximately $1.1 million and $1.7 million, respectively.
Share-based compensation expense related to all restricted stock awards outstanding during
the three months and six months ended June 30, 2006, was approximately $0.6 million and $1.0
million, respectively. As of June 30, 2007, the total amount of unrecognized compensation
cost related to non-vested restricted stock awards, to be recognized as expense subsequent
to June 30, 2007, was approximately $16.3 million, and the related weighted-average period
over which it is expected to be recognized is approximately 4.2 years.
A summary of restricted stock activity within the Companys share-based compensation
plans and changes for the six months ended June 30, 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant-Date |
Non-vested Shares |
|
Shares |
|
Fair Value |
Non-vested at December 31, 2006 |
|
|
295,579 |
|
|
$ |
29.98 |
|
|
Granted |
|
|
334,179 |
|
|
$ |
33.39 |
|
Vested |
|
|
(17,966 |
) |
|
$ |
29.37 |
|
Forfeited |
|
|
(5,862 |
) |
|
$ |
32.20 |
|
|
|
|
|
|
|
|
|
|
|
Non-vested at June 30, 2007 |
|
|
605,930 |
|
|
$ |
31.86 |
|
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the six months ended June 30,
2007 and the six months ended June 30, 2006 was approximately $0.5 million and $0.1 million,
respectively.
3. RESEARCH AND DEVELOPMENT COSTS AND ACCOUNTING FOR STRATEGIC COLLABORATIONS
All research and development costs, including payments related to products under
development and research consulting agreements, are expensed as incurred. The Company may
continue to make non-refundable payments to third parties for new technologies and for
research and development work that has been completed. These payments may be expensed at
the time of payment depending on the nature of the payment made.
The Companys policy on accounting for costs of strategic collaborations determines the
timing of the recognition of certain development costs. In addition, this policy determines
whether the cost is classified as development expense or capitalized as an asset.
Management is required to form judgments with respect to the commercial status of such
products in determining whether development costs meet the criteria for immediate expense or
capitalization. For example, when the Company acquires certain products for which there is
already an Abbreviated New Drug Application (ANDA) or a New Drug
Application (NDA) approval related directly to the product, and there is net realizable
value based on projected sales for these products, the Company capitalizes the amount paid
as an intangible asset. If the Company acquires product rights that are in the development
phase and as to which the Company has no assurance that the third party will successfully
complete its developmental milestones, the Company expenses such payments.
9
During 2003, the Company entered into numerous agreements with Q-Med AB (Q-Med), a
Swedish biotechnology/medical device company, for the rights to market, distribute and
commercialize the dermal restorative product lines known as RESTYLANE®,
PERLANE® and RESTYLANE FINE LINESTM. Under terms of the agreements,
the Company was to pay Q-Med milestone payments for the achievement of certain specific
development and commercial milestones. On May 2, 2007, the FDA approved PERLANE®
for implantation into the deep dermis to superficial subcutis for the correction of moderate
to severe facial folds and wrinkles, such as nasolabial folds. In accordance with the
Companys agreements with Q-Med, the Company paid $29.1 million to Q-Med during the three
months ended June 30, 2007 as a result of this milestone. The $29.1 million payment is
included in long-lived assets in the Companys condensed consolidated balance sheets as of
June 30, 2007, and is being amortized over its useful life.
During 2002, the Company entered into an exclusive license and development agreement
with Dow Pharmaceutical Sciences, Inc. (Dow) for the development and commercialization of
a patented dermatologic product. The product, ZIANATM, was approved by the FDA
during the three months ended December 31, 2006. The license and development agreement
included a one-time milestone payment of $1.0 million payable to Dow the first time the
product achieved a specific commercialization milestone during a 12-month period ending on
the anniversary of the products launch date. This milestone was achieved during the three
months ended June 30, 2007, and the $1.0 million milestone payment was accrued for as of
June 30, 2007, and was recorded as an addition to long-lived assets in the Companys
condensed consolidated balance sheets. In accordance with the agreement, the milestone is
payable during the three months ended March 31, 2008.
|
|
|
4. |
|
DEVELOPMENT AND DISTRIBUTION AGREEMENT WITH IPSEN FOR RIGHTS TO IPSENS
BOTULINUM TOXIN TYPE A PRODUCT KNOWN AS RELOXIN® |
On March 17, 2006, the Company entered into a development and distribution agreement
with Ipsen Ltd., a wholly-owned subsidiary of Ipsen S.A. (Ipsen), whereby Ipsen granted
Aesthetica Ltd., a wholly-owned subsidiary of Medicis, rights to develop, distribute and
commercialize Ipsens botulinum toxin type A product in the United States, Canada and Japan
for aesthetic use by physicians. The product is commonly referred to as RELOXIN®
in the U.S. aesthetic market and DYSPORT® in medical and aesthetic markets
outside the U.S. The product is not currently approved for use in the U.S., Canada or
Japan. Medicis made an initial payment to Ipsen in the amount of $90.1 million in
consideration for the exclusive distribution rights in the U.S., Canada and Japan.
Additionally, Medicis and Ipsen agreed to negotiate and enter into an agreement
relating to the exclusive distribution and development rights of the product for the
aesthetic market in Europe, and subsequently in certain other markets. Under the terms of
the U.S., Canada and Japan agreement, as amended, Medicis was obligated to make an
additional $35.1 million payment to Ipsen if this agreement was not entered into by April
15, 2006. On April 13, 2006, Medicis and Ipsen agreed to extend this deadline to July 15,
2006. In connection with this extension, Medicis paid Ipsen approximately $12.9 million in
April 2006, which would be applied against the total obligation, in the event an agreement
was not entered into by the extended deadline. On July 17, 2006, Medicis and Ipsen agreed
that the two companies would not pursue an agreement for the commercialization of the
product outside of the U.S., Canada and Japan. On July 17, 2006, Medicis made the
additional $22.2 million payment to Ipsen, representing the remaining portion of the $35.1
million total obligation, resulting from the discontinuance of negotiations for other
territories.
The initial $90.1 million payment was recognized as a charge to research and
development expense during the three months ended March 31, 2006, and the $35.1 million
obligation was recognized as a charge to research and development expense during the three
months ended June 30, 2006.
Medicis will pay an additional $26.5 million upon successful completion of various
clinical and regulatory milestones, $75.0 million upon the products approval by the FDA and
$2.0 million upon regulatory approval of the product in Japan. Ipsen will manufacture and
provide the product to Medicis for the term of the agreement, which
extends to December
2036. Ipsen will receive a royalty based on sales and a supply price, the total of which is
equivalent to approximately 30% of net sales as defined under the
10
agreement. Under the
terms of the agreement, Medicis is responsible for all remaining research and development
costs associated with obtaining the products approval in the U.S., Canada and Japan.
5. IMPAIRMENT OF LONG-LIVED ASSETS
The Company assesses the potential impairment of long-lived assets on a periodic basis
and when events or changes in circumstances indicate that the carrying value of the assets
may not be recoverable. Factors that the Company considers in deciding when to perform an
impairment review include significant under-performance of a product line in relation to
expectations, significant negative industry or economic trends, and significant changes or
planned changes in the Companys use of the assets. Recoverability of assets that will
continue to be used in the Companys operations is measured by comparing the carrying amount
of the asset grouping to the Companys estimate of the related total future net cash flows.
If an asset carrying value is not recoverable through the related cash flows, the asset is
considered to be impaired. The impairment is measured by the difference between the asset
groupings carrying amount and its fair value, based on the best information available,
including market prices or discounted cash flow analysis. If the assets determined to be
impaired are to be held and used, the Company recognizes an impairment loss through a charge
to operating results to the extent the present value of anticipated net cash flows
attributable to the asset are less than the assets carrying value. When it is determined
that the useful life of assets are shorter than originally estimated, and there are
sufficient cash flows to support the carrying value of the assets, the Company will
accelerate the rate of amortization charges in order to fully amortize the assets over their
new shorter useful lives.
During the quarter ended June 30, 2007, a long-lived asset related to
OMNICEF® was determined to be impaired based on the Companys analysis of the
long-lived assets carrying value and projected future cash flows. As a result of the
impairment analysis, the Company recorded a write-down of approximately $4.1 million related
to this long-lived asset.
Factors affecting the future cash flows of the OMNICEF® long-lived asset
included an early termination letter received during May 2007 from Abbott Laboratories, Inc.
(Abbott), which, in accordance with the Companys agreement with Abbott, transitions the
Companys co-promotion agreement into a two-year residual period, and competitive pressures
in the marketplace, including generic competition.
In addition, as a result of the impairment analysis, the remaining amortizable life of
the long-lived asset related to OMNICEF® was reduced to two years. The
long-lived asset related to OMNICEF® will become fully amortized by June 30,
2009. The net impact on amortization expense as a result of the write-down of the carrying
value of the long-lived asset and the reduction of its amortizable life is a decrease in
quarterly amortization expense of approximately $126,000.
6. MERGER OF ASCENT PEDIATRICS, INC.
As part of its merger with Ascent Pediatrics, Inc. (Ascent) which was completed in
November 2001, the Company was required to make contingent purchase price payments
(Contingent Payments) for each of the first five years following closing based upon
reaching certain sales threshold milestones on the Ascent products for each twelve month
period through November 15, 2006, subject to certain deductions and set-offs. Payment of
the contingent portion of the purchase price was withheld pending the final outcome of a
litigation matter. The Company distributed the accumulated $27.4 million in
Contingent Payments, representing the first four years Contingent Payments, to the
former shareholders of Ascent during the three months ended March 31, 2006, as the pending
litigation matter was settled in Medicis favor. In addition, the Company settled an
additional dispute during May 2006, which was initiated in March 2006, relating to the
concluded lawsuit. The resulting $1.8 million settlement was recognized as a charge to
selling, general and administrative expense during the three months ended March 31, 2006.
11
7. SHORT-TERM AND LONG-TERM INVESTMENTS
Available-for-sale securities consist of the following at June 30, 2007 (amounts in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
U.S. corporate securities |
|
$ |
344,686 |
|
|
$ |
114 |
|
|
$ |
371 |
|
|
$ |
344,429 |
|
Other debt securities |
|
|
338,775 |
|
|
|
9 |
|
|
|
318 |
|
|
|
338,466 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
683,461 |
|
|
$ |
123 |
|
|
$ |
689 |
|
|
$ |
682,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three months and six months ended June 30, 2007, the gross realized gains on
sales of available-for-sale securities totaled $25,625 and $48,460 respectively, while no
gross losses were realized. Such amounts of gains and losses are determined based on the
specific identification method. The net adjustment to unrealized gains during the three
months and six months ended June 30, 2007, on available-for-sale securities included in
stockholders equity totaled $(402,370) and $(212,990), respectively. The amortized cost and
estimated fair value of the available-for-sale securities at June 30, 2007, by maturity, are
shown below (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
415,406 |
|
|
$ |
415,141 |
|
Due after one year through five years |
|
|
205,805 |
|
|
|
205,504 |
|
Due after
five years through 10 years |
|
|
|
|
|
|
|
|
Due after 10 years |
|
|
62,250 |
|
|
|
62,250 |
|
|
|
|
|
|
|
|
|
|
$ |
683,461 |
|
|
$ |
682,895 |
|
|
|
|
|
|
|
|
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, 2007, approximately $148.4 million in estimated fair value expected to mature
greater than one year has been classified as long-term investments since these investments
are in an unrealized loss position and it is managements intent to hold these investments
until recovery of fair value, which may be maturity.
The following table shows the gross unrealized losses and 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, 2007 (amount in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
|
Greater Than 12 Months |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
U.S. corporate securities |
|
$ |
240,484 |
|
|
$ |
365 |
|
|
$ |
3,057 |
|
|
$ |
6 |
|
Other debt securities |
|
|
236,380 |
|
|
|
318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
476,864 |
|
|
$ |
683 |
|
|
$ |
3,057 |
|
|
$ |
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The unrealized losses on the Companys investments were caused primarily by interest
rate increases. It is expected that the investments will not be settled at a price less
than the amortized cost.
12
Because the Company has the ability, and intent, to hold these
investments until a recovery of fair value, which may be maturity, the Company does not
consider these investments to be other than temporarily impaired at June 30, 2007.
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
and contract revenue. The acne and acne-related dermatological product lines include
DYNACIN®, PLEXION®, SOLODYN®, TRIAZ® and
ZIANATM. The non-acne dermatological product lines include
LOPROX®, OMNICEF®, PERLANE®, RESTYLANE® and
VANOSTM. The non-dermatological product lines include
AMMONUL® and BUPHENYL®. 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, all products are sold primarily to
wholesalers and retail chain drug stores. Prior to October 2006, BUPHENYL® was
primarily sold directly to hospitals and pharmacies.
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, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Acne and acne-related
dermatological products |
|
$ |
55,435 |
|
|
$ |
36,644 |
|
|
$ |
101,383 |
|
|
$ |
50,650 |
|
Non-acne dermatological products |
|
|
46,173 |
|
|
|
40,421 |
|
|
|
86,816 |
|
|
|
90,966 |
|
Non-dermatological products |
|
|
7,256 |
|
|
|
7,967 |
|
|
|
15,779 |
|
|
|
18,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
108,864 |
|
|
$ |
85,032 |
|
|
$ |
203,978 |
|
|
$ |
160,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Acne and acne-related
dermatological products |
|
|
51 |
% |
|
|
43 |
% |
|
|
50 |
% |
|
|
31 |
% |
Non-acne dermatological products |
|
|
42 |
|
|
|
48 |
|
|
|
42 |
|
|
|
57 |
|
Non-dermatological products |
|
|
7 |
|
|
|
9 |
|
|
|
8 |
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
9. INVENTORIES
The Company utilizes third parties to manufacture and package inventories held for
sale, takes title to certain inventories once manufactured, and warehouses such goods until
packaged for final distribution and sale. Inventories consist of salable products held at
the Companys warehouses, as well as raw materials and components at the manufacturers
facilities, and are valued at the lower of cost or market using the first-in, first-out
method. The Company provides valuation reserves for estimated obsolescence or unmarketable
inventory in an amount equal to the difference between the cost of inventory and the
estimated market value based upon assumptions about future demand and market conditions.
Inventory costs associated with products that have not yet received regulatory approval
are capitalized if, in the view of the Companys management, there is probable future
commercial use and future economic benefit. If future commercial use and future economic
benefit are not considered probable, then costs associated with pre-launch inventory that
has not yet received regulatory approval are expensed as research and
13
development expense
during the period the costs are incurred. As of June 30, 2007 and December 31, 2006, there
are no costs capitalized into inventory for products that have not yet received regulatory
approval.
Inventories consist of the following at June 30, 2007 and December 31, 2006 (amounts in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
December 31, 2006 |
|
Raw materials |
|
$ |
7,137 |
|
|
$ |
8,637 |
|
Finished goods |
|
|
28,360 |
|
|
|
19,709 |
|
Valuation reserve |
|
|
(4,840 |
) |
|
|
(1,330 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
30,657 |
|
|
$ |
27,016 |
|
|
|
|
|
|
|
|
10. CONTINGENT CONVERTIBLE SENIOR NOTES
In June 2002, the Company sold $400.0 million aggregate principal amount of its 2.5%
Contingent Convertible Senior Notes Due 2032 (the Old Notes) in private transactions. As
discussed below, approximately $230.8 million in principal amount of the Old Notes was
exchanged for New Notes on August 14, 2003. The Old Notes bear interest at a rate of 2.5%
per annum, which is payable on June 4 and December 4 of each year, beginning on December 4,
2002. The Company also agreed to pay contingent interest at a rate equal to 0.5% per annum
during any six-month period, with the initial six-month period commencing June 4, 2007, if
the average trading price of the Old Notes reaches certain thresholds. 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, 2007 (extended to July 11, 2007), June 4, 2012 and 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, and contingent interest, if any,
to the date of the repurchase, payable in cash.
The
Old Notes are convertible, at the holders option, prior to the maturity date into shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after June 30, 2002, if the closing price of the
Companys Class A common stock over a specified number of trading days during the
previous quarter, including the last trading day of such quarter, is more than 110%
of the conversion price of the Old Notes, or $31.96. The Old Notes are initially
convertible at a conversion price of $29.05 per share, which is equal to a
conversion rate of approximately 34.4234 shares per $1,000 principal amount of Old
Notes, subject to adjustment; |
|
|
|
|
if the Company has called the Old Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive
day trading period in which the trading price of the Old Notes per $1,000 principal
amount for each day of such period was less than 95% of the product of the closing
sale price of the Companys Class A common stock on that day multiplied by the
number of shares of the Companys Class A common stock issuable upon conversion of
$1,000 principal amount of the Old Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The Old Notes, which are unsecured, do not contain any restrictions on the payment of
dividends, the incurrence of additional indebtedness or the repurchase of the Companys
securities and do not contain any financial covenants.
The Company incurred $12.6 million of fees and other origination costs related to the
issuance of the Old Notes. The Company amortized these costs over the first five-year Put
period, which ran through June 4, 2007.
14
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. The New Notes mature on June 4, 2033.
The Company may redeem some or all of the New Notes at any time on or after June 11,
2008, at a redemption price, payable in cash, of 100% of the principal amount of the New
Notes, plus accrued and unpaid interest, including contingent interest, if any. Holders of
the New Notes may require the Company to repurchase all or a portion of their New Notes on
June 4, 2008, 2013 and 2018, and upon a change in control, as defined in the indenture
governing the New Notes, 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.
The
New Notes are convertible, at the holders option, prior to the maturity date into shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after September 30, 2003, if the closing price of
the Companys Class A common stock over a specified number of trading days during
the previous quarter, including the last trading day of such quarter, is more than
120% of the conversion price of the New Notes, or $46.51. The Notes are initially
convertible at a conversion price of $38.76 per share, which is equal to a
conversion rate of approximately 25.7998 shares per $1,000 principal amount of New
Notes, subject to adjustment; |
|
|
|
|
if the Company has called the New Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive
day trading period in which the trading price of the New Notes per $1,000 principal
amount for each day of such period was less than 95% of the product of the closing
sale price of the Companys Class A common stock on that day multiplied by the
number of shares of the Companys Class A common stock issuable upon conversion of
$1,000 principal amount of the New Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The 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.
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. Both the New Notes and Old
Notes are reported in aggregate on the Companys condensed consolidated balance sheets. The
Company incurred approximately $5.1 million of fees and other origination costs related to
the issuance of the New Notes. The Company is amortizing these costs over the five-year Put
period, which runs through August 2008.
15
Contingent interest is not payable during the initial six-month period commencing June
4, 2007, as the average trading price of the Old Notes did not reach certain thresholds.
As of July 11, 2007, the closing date of the period whereby holders had the option to
require the Company to purchase their Old Notes for cash, holders of $5,000 of outstanding
principal amounts of the Old Notes exercised their right to require the Company to purchase
their Old Notes for cash.
During the quarters ended December 31, 2006, December 31, 2005, September 30, 2005,
December 31, 2004, September 30, 2004, June 30, 2004, March 31, 2004 and December 31, 2003,
the Old Notes met the criteria for the right of conversion into shares of the Companys
Class A common stock. This right of conversion of the holders of Old Notes was triggered by
the Companys Class A common stock closing above $31.96 on 20 of the last 30 trading days
and the last trading day of the quarters ended December 31, 2006, December 31, 2005,
September 30, 2005, December 31, 2004, September 30, 2004, June 30, 2004, March 31, 2004 and
December 31, 2003. The holders of Old Notes had this conversion right only until March 31,
2007. During the quarters ended June 30, 2007, March 31, 2007, September 30, 2006, June 30,
2006, March 31, 2006, June 30, 2005 and March 31, 2005, the Old 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. During the three months ended March 31,
2007, September 30, 2004 and March 31, 2004, outstanding principal amounts of $5,000, $2,000
and $6,000 of Old Notes, respectively, were converted into shares of the Companys Class A
common stock. As of August 9, 2007, no other Old Notes had been converted.
11. INCOME TAXES
Income taxes are determined using an annual effective tax rate, which generally differs
from the U.S. Federal statutory rate, primarily because of state and local income taxes,
charitable contribution deductions, tax credits available in the U.S., the treatment of
certain share-based payments under SFAS 123R that are not designed to normally result in tax
deductions, 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 the Company uses to estimate its annual effective
tax rate, including factors such as the Companys mix of pre-tax earnings in the various tax
jurisdictions in which the Company 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 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
deferred tax assets to reduce the net carrying values to amounts that are more likely than
not to be realized.
At June 30, 2007, the Company had a federal net operating loss carryforward of
approximately $14.2 million that will begin to expire in varying amounts in the years 2008
through 2020 if not previously utilized. The net operating loss carryforward was acquired
in connection with the Companys merger with Ascent during fiscal year 2002. As a result of
the merger and related ownership change for Ascent, the annual utilization of the net
operating loss carryforward is limited under Internal Revenue Code Section 382. The federal
net operating loss of $14.2 million is net of the Section 382 limitation, thus representing
the Companys estimate of the net operating loss carryforward that will be realized.
During the three months ended June 30, 2007 and June 30, 2006, the Company made net tax
payments of $4.9 million and $6.0 million, respectively. During the six months ended June
30, 2007 and June 30, 2006, the Company made net tax payments of $17.2 million and $26.7
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 fiscal 2004.
16
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 since this entitys formation in fiscal 2003 are open
under the statute of limitation.
The Company and its consolidated subsidiaries received a final notice of proposed
assessment in January 2007 from the Arizona Department of Revenue for fiscal years ended
2001 through 2004. The Arizona Department of Revenue has proposed adjustments related to
the subsidiaries to be included in the Companys combined Arizona tax return and to the
Companys apportionment of income to Arizona. In January 2007, the Company filed a protest
of the final assessment from the Arizona Department of Revenue. It is possible that the
Companys protest of the Arizona assessment may be resolved within the next twelve months.
However, at this time, the Company is unable to estimate the outcome of the protest or any
potential settlement with the state. The Company believes that it has made adequate
accruals for the assessment and does not believe that the resolution of the matters under
protest will have a material effect on the financial position of the Company. The final
settlement, when executed, may result in a significant reduction in the Companys
unrecognized tax benefit amount.
Effective January 1, 2007, the Company adopted FIN No. 48, Accounting for Uncertainty
in Income Taxes. In accordance with FIN No. 48, the Company recognized a cumulative-effect
adjustment of approximately $808,000, increasing its liability for unrecognized tax
benefits, interest, and penalties and reducing the January 1, 2007 balance of retained
earnings.
At January 1, 2007, the Company had $3.0 million in unrecognized tax benefits, the
recognition of which would have an effect of $1.8 million on the effective tax rate.
The Company recognizes accrued interest and penalties, if applicable, related to
unrecognized tax benefits in income tax expense. At January 1, 2007, the Company had
accrued $200,000 and $0 for the potential payment of interest and penalties on unrecognized
tax benefits, respectively.
There were no significant changes to any of these amounts during the first six months
of 2007.
12. DIVIDENDS DECLARED ON COMMON STOCK
On June 14, 2007, the Company declared a cash dividend of $0.03 per issued and
outstanding share of its Class A common stock payable on July 31, 2007 to stockholders of
record at the close of business on July 2, 2007. The $1.7 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, 2007.
13. COMPREHENSIVE INCOME (LOSS)
Total comprehensive income (loss) includes net income (loss) and other comprehensive
income, which consists of foreign currency translation adjustments and unrealized gains and
losses on available-for-sale investments. Total comprehensive income for the three months
and six months ended June 30, 2007 was $15.6
million and $25.0 million, respectively. Total comprehensive income for the three
months and six months ended June 30, 2006 was $14.5 million and $(72.9) million,
respectively.
17
14. NET INCOME (LOSS) PER COMMON SHARE
The following table sets forth the computation of basic and diluted net income (loss)
per common share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
15,523 |
|
|
$ |
15,519 |
|
|
$ |
24,811 |
|
|
$ |
(73,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
55,936 |
|
|
|
54,501 |
|
|
|
55,782 |
|
|
|
54,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss)
per common share |
|
$ |
0.28 |
|
|
$ |
0.28 |
|
|
$ |
0.44 |
|
|
$ |
(1.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
15,523 |
|
|
$ |
15,519 |
|
|
$ |
24,811 |
|
|
$ |
(73,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest
expense and
issue costs related to
Old Notes |
|
|
779 |
|
|
|
836 |
|
|
|
1,615 |
|
|
|
|
|
Tax-effected interest
expense and
issue costs related to
New Notes |
|
|
839 |
|
|
|
839 |
|
|
|
1,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) assuming
dilution |
|
$ |
17,141 |
|
|
$ |
17,194 |
|
|
$ |
28,103 |
|
|
$ |
(73,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares |
|
|
55,936 |
|
|
|
54,501 |
|
|
|
55,782 |
|
|
|
54,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
|
|
New Notes |
|
|
7,325 |
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
|
|
Stock options and restricted
stock |
|
|
2,234 |
|
|
|
2,084 |
|
|
|
2,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares assuming dilution |
|
|
71,318 |
|
|
|
69,733 |
|
|
|
71,466 |
|
|
|
54,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss)
per common share |
|
$ |
0.24 |
|
|
$ |
0.25 |
|
|
$ |
0.39 |
|
|
$ |
(1.34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per common share must be calculated using the
if-converted method in accordance with EITF 04-8, Effect of Contingently Convertible Debt
on Earnings per Share. Diluted net income (loss) per common share is calculated by
adjusting net income (loss) for tax-effected net interest and issue costs on the Old Notes
and New Notes, divided by the weighted average number of common shares outstanding assuming
conversion.
The diluted net income per common share computation for the three and six months ended
June 30, 2007 excludes 3,007,388 and 3,346,583 shares of stock that represented outstanding
stock options whose exercise price were greater than the average
market price of the common shares during the period and were anti-dilutive.
The diluted net income per common share computation for the three months ended June 30,
2006 excludes 5,912,426 shares of stock 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.
Due to the Companys net loss during the six months ended June 30, 2006, a calculation
of diluted earnings per
18
share is not required. For the six months ended June 30, 2006,
potentially dilutive securities consisted of restricted stock and stock options convertible
into 2,141,740 shares in the aggregate, and 5,822,894 and 7,324,819 shares of common stock,
issuable upon conversion of the Old Notes and New Notes, respectively.
15. CONTINGENCIES
On April 25, 2007, the Company entered into a Settlement Agreement with the Justice
Department, the Office of Inspector General of the Department of Health and Human Services
(OIG) and the TRICARE Management Activity (collectively, the United States) and private
complainants to settle all outstanding federal and state civil suits against the Company in
connection with claims related to the Companys alleged off-label marketing and promotion of
LOPROX® and LOPROX® TS products to pediatricians during periods prior
to the Companys May 2004 disposition of its pediatric sales division (the Settlement
Agreement). The settlement is neither an admission of liability by the Company nor a
concession by the United States that its claims are not well founded. Pursuant to the
Settlement Agreement, the Company agreed to pay approximately $10 million to settle the
matter. Pursuant to the Settlement Agreement, the United States released the Company from
the claims asserted by the United States and agreed to refrain from instituting action
seeking exclusion from Medicare, Medicaid, the TRICARE Program and other federal health care
programs for the alleged conduct. These releases relate solely to the allegations related
to the Company and do not cover individuals. The Settlement Agreement also provides that
the private complainants release the Company and its officers, directors and employees from
the asserted claims, and the Company releases the United States and the private complainants
from asserted claims. During 2006, the Company accrued a loss contingency of $10.2 million
for this matter in connection with the possibility of additional expenses related to the
settlement amount. Of this amount, $6.0 million was recorded during the three months ended
March 31, 2006, $2.0 million was recorded during the three months ended June 30, 2006, and
$2.2 million was recorded during the three months ended September 30, 2006. During the
three months ended June 30, 2007, $5.8 million of the settlement amount was paid pursuant to
the terms of the Settlement Agreement, and the remaining $4.4 million of accrued loss
contingency is included in other current liabilities as of June 30, 2007 in the accompanying
condensed consolidated balance sheets. For the three and six months ended June 30, 2006,
$2.0 million and $8.0 million, respectively, is included in selling, general and
administrative expenses in the accompanying condensed consolidated statements of income.
As part of the Settlement Agreement, the Company has entered into a five-year Corporate
Integrity Agreement (the CIA) with the OIG to resolve any potential administrative claims
the OIG may have arising out of the governments investigation. The CIA acknowledges the
existence of the Companys comprehensive existing compliance program and provides for
certain other compliance-related activities during the term of the CIA, including the
maintenance of a compliance program that, among other things, is designed to ensure
compliance with the CIA, federal health care programs and FDA requirements. Pursuant to the
CIA, the Company is required to notify the OIG, in writing, of: (i) any ongoing government
investigation or legal proceeding involving an allegation that the Company has committed a
crime or has engaged in fraudulent activities; (ii) any other matter that a reasonable
person would consider a probable violation of applicable criminal, civil, or administrative
laws; (iii) any written report, correspondence, or communication to the FDA that materially
discusses any unlawful or improper promotion of the Companys products; and (iv) any change
in location, sale, closing, purchase, or establishment of a new business unit or location
related to items or services that may be reimbursed by Federal health care programs. The
Company is also subject to periodic reporting and certification requirements attesting that
the provisions of the CIA are being implemented and followed, as well as certain document
and record retention mandates. The Company has hired a Chief Compliance Officer and created
an enterprise-wide compliance function to administer its obligations under the CIA.
On or about October 12, 2006, the Company and the United States Attorneys Office for
the District of Kansas entered into a Nonprosecution Agreement wherein the government agreed
not to prosecute the Company for any alleged criminal violations relating to the alleged
off-label marketing and promotion of LOPROX®. In exchange for the governments
agreement not to pursue any criminal
charges against the Company, the Company has agreed to continue cooperating with the
government in its ongoing investigation into whether past and present employees and officers
may have violated federal criminal law regarding alleged off-label marketing and promotion
of LOPROX® to pediatricians. Any such claims,
19
prosecutions or other proceedings,
with respect to the Companys past and present employees and officers, the cost of their
defense and fines and penalties resulting therefrom could have a material impact on the
Companys reputation, business and financial condition.
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 or
financial condition of the Company.
16. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which
clarifies the definition of fair value, establishes a framework for measuring fair value,
and expands the disclosures about fair value measurements. SFAS No. 157 is effective for
fiscal years beginning after November 15, 2007. The Company is currently evaluating SFAS
No. 157 and its impact, if any, on the Companys consolidated results of operations and
financial condition.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Statements and Financial Liabilities, which provides companies with an option to report
selected financial assets and liabilities at fair value. SFAS No. 159 requires companies to
provide additional information that will help investors and other users of financial
statements to more easily understand the effect of the companys choice to use fair value on
its earnings. It also requires entities to display the fair value of those assets and
liabilities for which the company has chosen to use fair value on the face of the balance
sheet. The new Statement does not eliminate disclosure requirements included in other
accounting standards, including requirements for disclosures about fair value measurements
included in FASB Statements No. 157, Fair Value Measurements, and No. 107, Disclosures about
Fair Value of Financial Instruments. The Company is currently evaluating SFAS No. 159 and
its impact, if any, on the Companys consolidated results of operations and financial
condition.
20
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Executive Summary
We are a leading independent specialty pharmaceutical company focusing primarily on
helping patients attain a healthy and youthful appearance and self-image through the
development and marketing in the U.S. of products for the treatment of dermatological,
aesthetic and podiatric conditions. We also market products in Canada for the treatment of
dermatological and aesthetic conditions. We offer a broad range of products addressing
various conditions or aesthetics improvements, including dermal fillers, acne, fungal
infections, rosacea, hyperpigmentation, photoaging, psoriasis, skin and skin-structure
infections, seborrheic dermatitis and cosmesis (improvement in the texture and appearance of
skin).
Our current product lines are divided between the dermatological and non-dermatological
fields. The dermatological field represents products for the treatment of acne and
acne-related dermatological conditions and non-acne dermatological conditions. The
non-dermatological field represents products for the treatment of urea cycle disorder and
contract revenue. Our acne and acne-related dermatological product lines include
DYNACIN®, PLEXION®, SOLODYN®, TRIAZ® and
ZIANATM. Our non-acne dermatological product lines include LOPROX®,
OMNICEF®, PERLANE®, RESTYLANE® and VANOSTM. Our
non-dermatological product lines include AMMONUL® and BUPHENYL®. Our
non-dermatological field also includes contract revenues associated with licensing
agreements and authorized generic agreements.
Key Aspects of Our Business
We derive a majority of our revenue from our primary products: PERLANE®,
RESTYLANE®, SOLODYN®, TRIAZ®, VANOS and
ZIANA. We believe that sales of our primary products will constitute a
significant portion of our sales for the foreseeable future.
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 relationships of trust and confidence with the high
prescribing dermatologists and podiatrists and the leading plastic surgeons in the U.S. We
rely on third parties to manufacture our products.
We schedule our inventory purchases to meet anticipated customer demand. As a result,
miscalculation of customer demand or relatively small delays in the 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. Depending on the customer, we recognize revenue at the
time of shipment to the customer, or at the time of receipt by the customer, net of
estimated provisions. 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 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 products.
Overestimates of demand may result in excessive inventory production and underestimates may
result in inadequate supply of our products in channels of distribution.
21
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. While we attempt to estimate inventory levels of our products at our
major wholesale customers by using historical prescription information and historical
purchase patterns, this process is inherently imprecise. Rarely do wholesale customers
provide us complete inventory levels at regional distribution centers, or within their
national distribution systems. We rely wholly upon our wholesale and drug chain customers
to effect the distribution allocation of substantially all of our products. Based upon
historically consistent purchasing patterns of our major wholesale customers, we believe our
estimates of trade inventory levels of our products 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.
We cannot control or significantly influence the purchasing patterns of our wholesale
and retail drug chain customers. They are highly sophisticated customers that purchase
products in a manner consistent with their industry practices and, presumably, based upon
their projected demand levels. 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
The following significant events and transactions occurred during the six months ended
June 30, 2007 and affected our results of operations, our cash flows and our financial
condition:
FDA approval of PERLANE®
On May 2, 2007, the FDA approved PERLANE® for implantation into the deep
dermis to superficial subcutis for the correction of moderate to severe facial folds and
wrinkles, such as nasolabial folds. In accordance with our agreements with Q-Med, we paid
$29.1 million to Q-Med during the three months ended June 30, 2007 as a result of this
milestone. The $29.1 million payment is included in long-lived assets in our condensed
consolidated balance sheets as of June 30, 2007. The first commercial sales of
PERLANE® occurred during May 2007.
Write-down of long-lived asset related to OMNICEF® due to impairment
We assess the potential impairment of long-lived assets on a periodic basis and when
events or changes in circumstances indicate that the carrying value of the assets may not be
recoverable. Factors that we consider in deciding when to perform an impairment review
include significant under-performance of a product line in relation to expectations,
significant negative industry or economic trends, and significant changes or planned changes
in our use of the assets. Recoverability of assets that will continue to be used in our
operations is measured by comparing the carrying amount of the asset grouping
to our estimate of the related total future net cash flows. If an asset carrying value
is not recoverable through the related cash flows, the asset is considered to be impaired.
The impairment is measured by the difference between the asset groupings carrying amount
and its fair value, based on the best information available, including
22
market prices or
discounted cash flow analysis. If the assets determined to be impaired are to be held and
used, we recognize an impairment loss through a charge to operating results to the extent
the present value of anticipated net cash flows attributable to the asset are less than the
assets carrying value. When it is determined that the useful life of assets are shorter
than originally estimated, and there are sufficient cash flows to support the carrying value
of the assets, we will accelerate the rate of amortization charges in order to fully
amortize the assets over their new shorter useful lives.
During the quarter ended June 30, 2007, a long-lived asset related to
OMNICEF® was determined to be impaired based on our analysis of the long-lived
assets carrying value and projected future cash flows. As a result of the impairment
analysis, we recorded a write-down of approximately $4.1 million related to this long-lived
asset.
Factors affecting the future cash flows of the OMNICEF® long-lived asset
included an early termination letter received during May 2007 from Abbott, which, in
accordance with our agreement with Abbott, transitions our co-promotion agreement into a
two-year residual period, and competitive pressures in the marketplace, including generic
competition.
In addition, as a result of the impairment analysis, the remaining amortizable life of
the long-lived asset related to OMNICEF® was reduced to two years. The
long-lived asset related to OMNICEF® will become fully amortized by June 30,
2009. The net impact on amortization expense as a result of the write-down of the carrying
value of the long-lived asset and the reduction of its amortizable life is a decrease in
quarterly amortization expense of approximately $126,000.
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, |
|
|
2007 (a) |
|
2006 (b) |
|
2007 (c) |
|
2006 (d) |
|
|
|
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (e) |
|
|
87.1 |
|
|
|
88.9 |
|
|
|
88.0 |
|
|
|
86.5 |
|
Operating expenses |
|
|
70.6 |
|
|
|
118.3 |
|
|
|
74.9 |
|
|
|
159.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
16.5 |
|
|
|
(29.4 |
) |
|
|
13.1 |
|
|
|
(72.6 |
) |
Interest and investment
income (expense), net |
|
|
6.1 |
|
|
|
5.4 |
|
|
|
6.4 |
|
|
|
5.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income
tax expense (benefit) |
|
|
22.6 |
|
|
|
(24.0 |
) |
|
|
19.5 |
|
|
|
(67.0 |
) |
Income tax expense (benefit) |
|
|
8.3 |
|
|
|
(42.3 |
) |
|
|
7.3 |
|
|
|
(21.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
14.3 |
% |
|
|
18.3 |
% |
|
|
12.2 |
% |
|
|
(45.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $5.6 million (5.2% of net revenues) of share-based
compensation expense and $4.1 million (3.7% of net revenues) for the write-down of a
long-lived asset related to OMNICEF®. |
|
(b) |
|
Included in operating expenses is $35.1 million (41.2% of net revenues) related
to our development and distribution agreement |
|
|
|
with Ipsen for the development of RELOXIN®, $7.3 million (8.6% of
net revenues) of share-based compensation expense and |
|
|
|
$2.0 million (2.4% of net revenues) related to a loss contingency for a legal matter. |
|
(c) |
|
Included in operating expenses is $11.2 million (5.5% of net revenues) of
share-based compensation expense and $4.1 million (2.0% of net revenues) for the
write-down of a long-lived asset related to OMNICEF®. |
|
(d) |
|
Included in operating expenses is $125.2 million (78.1% of net revenues)
related to our development and distribution agreement with Ipsen for the development of
RELOXIN®, $14.5 million (9.1% of net revenues) of share-based compensation
expense, $8.0 million (5.0% of net revenues) related to a loss contingency for a legal
matter and $1.8 million (1.1% of net revenues) related to a settlement of a dispute
related to our merger with Ascent. |
|
(e) |
|
Gross profit does not include amortization of the related intangibles, as such
expenses are included in operating expenses. |
23
Three Months Ended June 30, 2007 Compared to the Three Months Ended June 30, 2006
Net Revenues
The following table sets forth the net revenues for the three months ended June 30,
2007 (the second quarter of 2007) and June 30, 2006 (the second quarter of 2006), along
with the percentage of net revenues and percentage point change for each of our product
categories (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
|
Second |
|
|
|
|
|
|
|
|
|
Quarter |
|
|
Quarter |
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
%
Change |
|
Net product revenues |
|
$ |
105.9 |
|
|
$ |
80.6 |
|
|
$ |
25.3 |
|
|
|
31.3 |
% |
Net contract revenues |
|
$ |
3.0 |
|
|
$ |
4.4 |
|
|
$ |
(1.4 |
) |
|
|
(32.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
108.9 |
|
|
$ |
85.0 |
|
|
$ |
23.9 |
|
|
|
28.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
|
Second |
|
|
|
|
|
|
|
|
|
Quarter |
|
|
Quarter |
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
Acne and acne-related
dermatological products |
|
$ |
55.4 |
|
|
$ |
36.6 |
|
|
$ |
18.8 |
|
|
|
51.3 |
% |
Non-acne dermatological
products |
|
|
46.2 |
|
|
|
40.4 |
|
|
|
5.8 |
|
|
|
14.2 |
% |
Non-dermatological products
(including contract revenues) |
|
|
7.3 |
|
|
|
8.0 |
|
|
|
(0.7 |
) |
|
|
(8.9 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
108.9 |
|
|
$ |
85.0 |
|
|
$ |
23.9 |
|
|
|
28.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
Percentage |
|
|
Quarter |
|
Quarter |
|
Point |
|
|
2007 |
|
2006 |
|
Change |
Acne and acne-related
dermatological products |
|
|
50.9 |
% |
|
|
43.1 |
% |
|
|
7.8 |
% |
Non-acne dermatological
products |
|
|
42.4 |
% |
|
|
47.5 |
% |
|
|
(5.1 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
6.7 |
% |
|
|
9.4 |
% |
|
|
(2.7 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues increased during the second quarter of 2007 primarily as a
result of an increase in sales of SOLODYN®, which was approved by the FDA during
the second quarter of 2006, ZIANA, which was approved by the FDA during the
fourth quarter of 2006, and PERLANE®, which was approved by the FDA during the
second quarter of 2007. Net revenues associated with our acne and acne-related
dermatological products increased by $18.8 million, or 51.3%, and by 7.8 percentage points
as a percentage of net revenues during the second quarter of 2007 as compared to the second
quarter of 2006 as a result of the increased sales of SOLODYN® and
ZIANA. Net revenues associated with our non-acne dermatological products
decreased as a percentage of net revenues, but increased in net dollars by 14.2% during the
second quarter of 2007. This change was primarily due to the launch of PERLANE®,
and increases in sales of LOPROX® and VANOS. Net revenues associated
with our non-dermatological products decreased as a percentage of net revenues, and
decreased in net dollars by 8.9% during the second quarter of 2007 as compared to the second
quarter of 2006, primarily due to a decrease 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 intangible
assets for the second quarter of 2007 and
24
2006 was approximately $5.2 million and $5.1
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 2007 and the
second quarter of 2006, along with the percentage of net revenues represented by such gross
profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
94.9 |
|
|
$ |
75.6 |
|
|
$ |
19.3 |
|
|
|
25.4 |
% |
% of net revenues |
|
|
87.1 |
% |
|
|
88.9 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the second quarter of 2007, compared to the second
quarter of 2006, was due to the increase in our net revenues, while the decrease in gross
profit as a percentage of net revenues was primarily due to the fluctuation in the mix of
product sales and an increase in our inventory obsolescence reserve of approximately $3.3
million during the second quarter of 2007.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the
second quarter of 2007 and the second quarter of 2006, along with the percentage of net
revenues represented by selling, general and administrative expenses (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
59.9 |
|
|
$ |
51.1 |
|
|
$ |
8.8 |
|
|
|
17.3 |
% |
% of net revenues |
|
|
55.0 |
% |
|
|
60.1 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
5.5 |
|
|
$ |
6.8 |
|
|
$ |
(1.3 |
) |
|
|
(19.2 |
)% |
The increase in selling, general and administrative expenses during the second quarter
of 2007 from the second quarter of 2006 was attributable to approximately $4.2 million of
increased personnel costs, primarily related to an increase in the number of employees
(increasing from 362 as of June 30, 2006 to 467 as of June 30, 2007) and the effect of the
annual salary increase that occurred during February 2007, $1.5 million of increased
promotion expense, primarily related to the promotion of new products ZIANA and
PERLANE®, $4.1 million of increased professional and consulting expenses,
including costs related to the development and implementation of our new enterprise resource
planning (ERP) system (net of costs capitalized), and $1.6 million of other additional
selling, general and administrative expenses incurred during the second quarter of 2007.
These increases were partially offset by certain costs incurred during the second quarter of
2006 that were not incurred during the second quarter of 2007, including $2.0 million
related to a loss contingency for a legal matter and approximately $0.5 million of
professional and other expenses related to our development and distribution agreement with
Ipsen for the development of RELOXIN®.
Impairment of Long-lived Assets
During the second quarter of 2007, a long-lived asset related to OMNICEF®
was determined to be impaired based on our analysis of the long-lived assets carrying value
and projected future cash flows. As a result of the impairment analysis, we recorded a
write-down of approximately $4.1 million related to this long-lived asset.
Factors affecting the future cash flows of the OMNICEF® long-lived asset
included an early termination letter received during May 2007 from Abbott, which transitions
our co-promotion agreement with Abbott into a two-year residual period, and competitive
pressures in the marketplace, including generic competition.
25
Research and Development Expenses
The following table sets forth our research and development expenses for the second
quarter of 2007 and the second quarter of 2006 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Research and development |
|
$ |
7.1 |
|
|
$ |
43.8 |
|
|
$ |
(36.7 |
) |
|
|
(83.7 |
)% |
Charges included in research
and development |
|
$ |
|
|
|
$ |
35.1 |
|
|
$ |
(35.1 |
) |
|
|
(100.0 |
)% |
Share-based compensation
expense included in
research and development |
|
$ |
0.1 |
|
|
$ |
0.5 |
|
|
$ |
(0.4 |
) |
|
|
(76.8 |
)% |
Included in research and development expenses for the second quarter of 2007 was
approximately $0.1 million of share-based compensation. Included in research and
development expense for the second quarter of 2006 was $35.1 million related to the
development and distribution agreement with Ipsen for the development of RELOXIN®
and approximately $0.5 million of share-based compensation expense. The primary product
under development during the second quarter of 2007 and the second quarter of 2006 was
RELOXIN®. 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. We expect to continue to incur
significant research and development expenses related to the development of
RELOXIN® each quarter throughout the development process.
In accordance with our development and distribution agreement with Ipsen for the
development of RELOXIN®, we will pay Ipsen $26.5 million upon successful
completion of various clinical and regulatory milestones, including a $25.0 million payment
upon the FDAs acceptance of the first filing of a Biologics License Application, which may
occur during the three months ended December 31, 2007. We will recognize these milestone
payments as research and development expense when incurred.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the second quarter of 2007 increased $0.1
million, or 1.3%, to $5.9 million from $5.8 million during the second quarter of 2006. This
increase included initial amortization of a $29.1 million milestone payment made to Q-Med
related to the FDA approval of PERLANE® during the second quarter of 2007. This
increase in amortization was partially offset by a decrease in amortization due to the
write-down of long-lived assets due to impairment during the three months ended September
30, 2006. The remaining amortizable lives of these long-lived assets were also shortened.
These long-lived assets had an aggregate cost basis of approximately $76.6 million and were
being amortized at a rate of approximately $0.4 million per quarter. These long-lived
assets were written-down to an aggregate new cost basis of approximately $3.6 million, and
are being amortized at an aggregate rate of approximately $0.1 million per quarter.
Interest and Investment Income
Interest and investment income during the second quarter of 2007 increased $2.0
million, or 27.4%, to $9.3 million from $7.3 million during the second quarter of 2006, due
to an increase in the funds available for investment and an increase in the interest rates
achieved by our invested funds during the second quarter of 2007.
26
Interest Expense
Interest expense during the second quarter of 2007 decreased $0.1 million, to $2.6
million during the second quarter of 2007 from $2.7 million during the second quarter of
2006. Our interest expense during the second quarter of 2007 and 2006 consisted of interest
expense on our Old Notes, which accrue interest at 2.5% per annum, our New Notes, which
accrue interest at 1.5% per annum, and amortization of fees and other origination costs
related to the issuance of the Old Notes and New Notes. The decrease in interest expense
during the second quarter of 2007 as compared to the second quarter of 2006 was due to the
fees and origination costs related to the issuance of the Old Notes becoming fully amortized
during the second quarter of 2007. See Note 10 in our accompanying condensed consolidated
financial statements for further discussion on the Old Notes and New Notes.
Income Tax Expense
Income taxes are determined using an annual effective tax rate, which generally differs
from the U.S. Federal statutory rate, primarily because of state and local income taxes,
enhanced charitable contribution deductions for inventory, tax credits available in the
U.S., the treatment of certain share-based payments under SFAS 123R that are not designed to
normally result in tax deductions, various expenses that are not deductible for tax
purposes, and differences in tax rates in certain non-U.S. jurisdictions. Our effective tax
rate may be subject to fluctuations during the year as new information is obtained which may
affect the assumptions we use to estimate our annual effective tax rate, including factors
such as our mix of pre-tax earnings in the various tax jurisdictions in which we operate,
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
we conduct operations. We recognize deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax basis of our assets and
liabilities, along with net operating losses and credit carryforwards. We record valuation
allowances against our deferred tax assets to reduce the net carrying values to amounts that
management believes is more likely than not to be realized.
Our effective tax rate for the second quarter of 2007 was 36.8% compared to our
effective tax rate of (176.0)% for the second quarter of 2006. The provision for income
taxes generally reflects managements estimate of the effective tax rate expected to be
applicable for the full fiscal year. However, during the second quarter of 2006, the
Companys effective tax rate of (176.0%) differed from the Companys estimate of the
effective tax rate for the full fiscal year primarily as a result of an election, solely for
tax purposes, to treat Aesthetica Ltd., a company incorporated and registered under the laws
of Bermuda and not previously subject to income taxes, as an entity disregarded from its
U.S. owner, Medicis Aesthetics Holding Inc., a wholly owned subsidiary of Medicis
Pharmaceutical Corporation, and thus fiscally transparent for purposes of the U.S. Internal
Revenue Code. Thus, research and development expenses related to the development of
RELOXIN® will be treated for U.S. tax purposes as made directly by Medicis Aesthetics
Holding Inc. and deductible in the U.S. This election allowed the Company to record U.S.
tax benefits of $39.7 million during the second quarter of 2006 on research and development
expenses related to the development of RELOXIN®.
27
Six Months Ended June 30, 2007 Compared to the Six Months Ended June 30, 2006
Net Revenues
The following table sets forth the net revenues for the six months ended June 30, 2007
(the 2007 six months) and the six months ended June 30, 2006 (the 2006 six months),
along with the percentage of net revenues and percentage point change for each of our
product categories (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
|
2006 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
%
Change |
|
Net product revenues |
|
$ |
198.3 |
|
|
$ |
151.7 |
|
|
$ |
46.6 |
|
|
|
30.7 |
% |
Net contract revenues |
|
$ |
5.7 |
|
|
$ |
8.5 |
|
|
$ |
(2.8 |
) |
|
|
(32.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
204.0 |
|
|
$ |
160.2 |
|
|
$ |
43.8 |
|
|
|
27.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
|
2006 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$Change |
|
|
% Change |
|
Acne and acne-related
dermatological products |
|
$ |
101.4 |
|
|
$ |
50.6 |
|
|
$ |
50.8 |
|
|
|
100.2 |
% |
Non-acne dermatological
products |
|
|
86.8 |
|
|
|
91.0 |
|
|
|
(4.2 |
) |
|
|
(4.6 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
15.8 |
|
|
|
18.6 |
|
|
|
(2.8 |
) |
|
|
(15.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
204.0 |
|
|
$ |
160.2 |
|
|
$ |
43.8 |
|
|
|
27.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
2007 Six |
|
2006 Six |
|
Point |
|
|
Months |
|
Months |
|
Change |
Acne and acne-related
dermatological products |
|
|
49.7 |
% |
|
|
31.6 |
% |
|
|
18.1 |
% |
Non-acne dermatological
products |
|
|
42.6 |
% |
|
|
56.8 |
% |
|
|
(14.2 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
7.7 |
% |
|
|
11.6 |
% |
|
|
( 3.9 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues increased during the 2007 six months primarily as a result of an
increase in sales of SOLODYN®, which was approved by the FDA during the second
quarter of 2006, ZIANA, which was approved by the FDA during the fourth quarter
of 2006, and PERLANE®, which was approved by the FDA during the second quarter of
2007. Net revenues associated with our acne and acne-related dermatological products
increased by $50.8 million, or 100.2%, and by 18.1 percentage points as a percentage of net
revenues during the 2007 six months as compared to the 2006 six months as a result of the
increased sales of SOLODYN® and ZIANA. Net revenues associated with
our non-acne dermatological products decreased as a percentage of net revenues, and
decreased in net dollars by 4.6% during the 2007 six months. This change included initial
sales of PERLANE®, and an increase in sales of LOPROX®, offset by a
decrease in sales of RESTYLANE® due to the recent introduction of several
competitive products. Net revenues associated with our non-dermatological products
decreased as a percentage of net revenues, and decreased in net dollars by 15.0% during the
2007 six months as compared to the 2006 six months, primarily due to a decrease 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 intangible assets for the 2007 and
2006 six months was approximately $10.0 million and $10.2 million, respectively. Product
mix plays a significant role in our
28
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 2007 six months and the 2006
six months, along with the percentage of net revenues represented by such gross profit
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
2006 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
179.5 |
|
|
$ |
138.6 |
|
|
$ |
40.9 |
|
|
|
29.5 |
% |
% of net revenues |
|
|
88.0 |
% |
|
|
86.5 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the 2007 six months, compared to the 2006 six
months, was due to the increase in our net revenues and the increase in gross profit as a
percentage of net revenues was primarily due to the different mix of high gross margin
products sold during the 2007 six months as compared to the 2006 six months. The launch of
SOLODYN®, a higher margin product, during the second quarter of 2006, was the
primary change in the mix of products sold during the comparable periods that affected gross
profit as a percentage of net revenues. The impact of the mix of higher margin products
being sold during the 2007 six months as compared to the 2006 six months was partially
offset by a $3.5 million increase in our inventory obsolescence reserve recorded during the
2007 six months, as compared to a $0.4 million decrease in our inventory obsolescence
reserve during the 2006 six months. The change was due to an increase in inventory during
the 2007 six months projected to not be sold by expiry dates.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the
2007 six months and 2006 six months, along with the percentage of net revenues represented
by selling, general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
2006 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
122.2 |
|
|
$ |
102.3 |
|
|
$ |
19.9 |
|
|
|
19.4 |
% |
% of net revenues |
|
|
59.9 |
% |
|
|
63.9 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
10.9 |
|
|
$ |
13.5 |
|
|
$ |
(2.6 |
) |
|
|
(19.2 |
)% |
The increase in selling, general and administrative expenses during the 2007 six months
from the 2006 six months was attributable to approximately $10.4 million of increased
personnel costs, primarily related to an increase in the number of employees (increasing
from 362 as of June 30, 2006 to 467 as of June 30, 2007) and the effect of the annual salary
increase that occurred during February 2007, $7.1 million of increased promotion expense,
primarily related to the promotion of new products SOLODYN®, ZIANA
and PERLANE®, $7.7 million of increased professional and consulting expenses,
including costs related to the development and implementation of our new enterprise resource
planning (ERP) system (net of costs capitalized), and $5.4 million of other additional
selling, general and administrative expenses incurred during the 2007 six months. These
increases were partially offset by certain costs incurred during the 2006 six months that
were not incurred during the 2007 six months, including $8.0 million related to a loss
contingency for a legal matter, $1.8 million related to a settlement of a dispute related to
our merger with Ascent and approximately $1.0 million of professional and other expenses
related to our development and distribution agreement with Ipsen for the development of
RELOXIN®.
Impairment of Long-lived Assets
During the second quarter of 2007, a long-lived asset related to OMNICEF®
was determined to be impaired based on our analysis of the long-lived assets carrying value
and projected future cash flows. As a result of the impairment analysis, we recorded a
write-down of approximately $4.1 million related to this long-lived asset.
29
Factors affecting the future cash flows of the OMNICEF® long-lived asset
included an early termination letter received during May 2007 from Abbott, which transitions
our co-promotion agreement with Abbott into a two-year residual period, and competitive
pressures in the marketplace, including generic competition.
Research and Development Expenses
The following table sets forth our research and development expenses for the 2007 six
months and 2006 six months (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
2006 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Research and development |
|
$ |
15.2 |
|
|
$ |
141.0 |
|
|
$ |
(125.8 |
) |
|
|
(89.3 |
)% |
Charges included in research
and development |
|
$ |
|
|
|
$ |
125.2 |
|
|
$ |
(125.2 |
) |
|
|
(100.0 |
)% |
Share-based compensation
expense included in
research and development |
|
$ |
0.3 |
|
|
$ |
1.0 |
|
|
$ |
(0.7 |
) |
|
|
(75.4 |
)% |
Included in research and development expenses for the 2007 six months was approximately
$0.3 million of share-based compensation. Included in research and development expense for
the 2006 six months was $125.2 million related to the development and distribution agreement
with Ipsen for the development of RELOXIN® and approximately $1.0 million of
share-based compensation expense. The primary product under development during the 2007 six
months and the 2006 six months was RELOXIN®.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the 2007 six months decreased $0.4
million, or 2.8%, to $11.3 million from $11.7 million during the 2006 six months. This
decrease was primarily due to the amount of intangible assets being amortized during the
2007 six months compared to the 2006 six months, due to the write-down of long-lived assets
due to impairment during the three months ended September 30, 2006. The remaining
amortizable lives of these long-lived assets were also shortened. These long-lived assets
had an aggregate cost basis of approximately $76.6 million and were being amortized at a
rate of approximately $0.4 million per quarter. These long-lived assets were written-down
to an aggregate new cost basis of approximately $3.6 million, and are being amortized at an
aggregate rate of approximately $0.1 million per quarter. This decrease was partially
offset by initial amortization of a $29.1 million milestone payment made to Q-Med related to
the FDA approval of PERLANE® during the second quarter of 2007.
Interest and Investment Income
Interest income during the 2007 six months increased $4.0 million, or 27.8%, to $18.3
million from $14.3 million during the 2006 six months, due to an increase in the funds
available for investment and an increase in the interest rates achieved by our invested
funds during the 2007 six months.
Interest Expense
Interest expense during the 2007 six months decreased $0.1 million, to $5.2 million
during the 2007 six months from $5.3 million during the 2006 six months. Our interest
expense during the 2007 and 2006 six months consisted of interest expense on our Old Notes,
which accrue interest at 2.5% per annum, our New Notes, which accrue interest at 1.5% per
annum, and amortization of fees and other origination costs related to the issuance of the
Old Notes and New Notes. The decrease in interest expense during the 2007 six months as
compared to the 2006 six months was due to the fees and origination costs related to
the issuance of the Old Notes becoming fully amortized during the second quarter of 2007.
See Note 10 in our accompanying condensed consolidated financial statements for further
discussion on the Old Notes and New Notes.
30
Income Tax Expense
The following table sets forth our income tax expense and the resulting effective tax
rate stated as a percentage of pre-tax income for the 2007 six months and 2006 six months
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
2006 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Income tax (benefit) expense |
|
$ |
15.0 |
|
|
$ |
(34.3 |
) |
|
$ |
49.3 |
|
|
|
143.6 |
% |
Effective tax rate |
|
|
37.7 |
% |
|
|
(32.0 |
)% |
|
|
|
|
|
|
|
|
Income taxes are determined using an annual effective tax rate, which generally differs
from the U.S. Federal statutory rate, primarily because of state and local income taxes,
enhanced charitable contribution deductions for inventory, tax credits available in the
U.S., the treatment of certain share-based payments under SFAS 123R that are not designed to
normally result in tax deductions, various expenses that are not deductible for tax
purposes, and differences in tax rates in certain non-U.S. jurisdictions. Our effective tax
rate may be subject to fluctuations during the year as new information is obtained which may
affect the assumptions we use to estimate our annual effective tax rate, including factors
such as our mix of pre-tax earnings in the various tax jurisdictions in which we operate,
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
we conduct operations. We recognize deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax basis of our assets and
liabilities, along with net operating losses and credit carryforwards. We record valuation
allowances against our deferred tax assets to reduce the net carrying values to amounts that
management believes is more likely than not to be realized.
Our effective tax rate for the 2007 six months was 37.7% compared to our effective tax
rate of (32.0)% for the 2006 six months. Generally, the provision for income taxes reflects
managements estimate of the effective tax rate expected to be applicable for the full
fiscal year. However, during the 2006 six months, our effective tax rate of (32.0%)
differed from our estimate of the effective tax rate for the full fiscal year primarily due
to a discrete tax benefit of $5.1 million recorded during the second quarter of 2006
relating to resolutions of income tax examinations for tax years ended through June 30,
2004.
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the 2007 six months
and 2006 six months, and selected balance sheet components as of June 30, 2007 and December
31, 2006 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
2006 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
79.1 |
|
|
|
(100.4 |
) |
|
$ |
179.5 |
|
|
|
178.7 |
% |
Investing activities |
|
$ |
(234.4 |
) |
|
|
(126.9 |
) |
|
|
(107.5 |
) |
|
|
(84.8 |
)% |
Financing activities |
|
$ |
13.6 |
|
|
$ |
3.2 |
|
|
$ |
10.4 |
|
|
|
320.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
Dec. 31, 2006 |
|
$ Change |
|
% Change |
Cash, cash equivalents and
short-term investments |
|
$ |
596.5 |
|
|
$ |
554.3 |
|
|
$ |
42.2 |
|
|
|
7.6 |
% |
Working capital |
|
$ |
570.7 |
|
|
$ |
550.0 |
|
|
$ |
20.7 |
|
|
|
3.8 |
% |
Long-term investments |
|
$ |
148.4 |
|
|
$ |
130.3 |
|
|
$ |
18.1 |
|
|
|
13.9 |
% |
2.5% contingent convertible
senior notes due 2032 |
|
$ |
169.2 |
|
|
$ |
169.2 |
|
|
$ |
|
|
|
|
|
|
1.5% contingent convertible
senior notes due 2033 |
|
$ |
283.9 |
|
|
$ |
283.9 |
|
|
$ |
|
|
|
|
|
|
31
Working Capital
Working capital as of June 30, 2007 and December 31, 2006 consisted of the following
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2007 |
|
|
Dec. 31, 2006 |
|
|
$ Change |
|
|
% Change |
|
Cash, cash equivalents and
short-term investments |
|
$ |
596.5 |
|
|
$ |
554.3 |
|
|
$ |
42.2 |
|
|
|
7.6 |
% |
Accounts receivable, net |
|
|
|
|
|
|
36.4 |
|
|
|
(36.4 |
) |
|
|
(100.0 |
)% |
Inventories, net |
|
|
30.7 |
|
|
|
27.0 |
|
|
|
3.7 |
|
|
|
13.5 |
% |
Deferred tax assets, net |
|
|
22.9 |
|
|
|
23.0 |
|
|
|
(0.1 |
) |
|
|
(0.5 |
)% |
Other current assets |
|
|
19.2 |
|
|
|
16.0 |
|
|
|
3.2 |
|
|
|
19.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
669.3 |
|
|
|
656.7 |
|
|
|
12.6 |
|
|
|
1.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
40.5 |
|
|
|
47.5 |
|
|
|
(7.0 |
) |
|
|
(14.7 |
)% |
Income taxes payable |
|
|
0.4 |
|
|
|
11.3 |
|
|
|
(10.9 |
) |
|
|
(96.2 |
)% |
Other current liabilities |
|
|
57.7 |
|
|
|
47.9 |
|
|
|
9.8 |
|
|
|
20.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
98.6 |
|
|
|
106.7 |
|
|
|
(8.1 |
) |
|
|
(7.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
570.7 |
|
|
$ |
550.0 |
|
|
$ |
20.7 |
|
|
|
3.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $596.5 million and working
capital of $570.7 million at June 30, 2007, as compared to $554.3 million and $550.0
million, respectively, at December 31, 2006. The increases were primarily due to the
generation of $79.1 million of operating cash flow and $15.8 million of cash received from
employees exercise of stock options during the 2007 six months, partially offset by the
payment of $29.1 to Q-Med upon the FDAs approval of PERLANE® and a net transfer
of $18.1 million of our short-term investments into long-term investments during the 2007
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,
strategic investments, acquisitions of companies or products complimentary 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.
During July 2006, we completed a lease agreement for new headquarter office space to
accommodate our expected long-term growth. The first phase is for approximately 150,000
square feet with the right to expand. We expect to occupy the new headquarter office space,
which is located approximately one mile from our current headquarter office space in
Scottsdale, Arizona, in 2008. There is no financial obligation for lease payments until
2008.
During October 2006, we executed a lease agreement for additional headquarter office
space, which is also located approximately one mile from our current headquarter office
space in Scottsdale, Arizona, to accommodate our current needs and future growth.
Approximately 21,000 square feet of office space is being leased for a period of three
years. In May 2007, we began occupancy of the additional headquarter office space.
During 2007 and 2008, we will be designing and implementing a new enterprise resource
planning (ERP) system to integrate and improve the financial and operational aspects of our
business. We have dedicated approximately 50 of our employees to various aspects of the
project, along with third party
consultants. We expect this project will require an aggregate investment of approximately
$10 $12 million during 2007 and 2008.
32
Operating Activities
Net cash provided by operating activities during the 2007 six months was approximately
$79.1 million, compared to net cash used in operating activities during the 2006 six months
of approximately $100.4 million. The following is a summary of the primary components of
cash provided by (used in) operating activities during the 2007 six months and 2006 six
months (in millions):
|
|
|
|
|
|
|
|
|
|
|
2007 Six |
|
|
2006 Six |
|
|
|
Months |
|
|
Months |
|
Payments made to Ipsen related to development of RELOXIN® |
|
$ |
|
|
|
$ |
(103.0 |
) |
Payment of professional fees related to termination of proposed
merger with Inamed |
|
|
|
|
|
|
(16.7 |
) |
Income taxes paid |
|
|
(17.2 |
) |
|
|
(26.7 |
) |
Other cash provided by operating activities |
|
|
96.3 |
|
|
|
46.0 |
|
|
|
|
|
|
|
|
Cash provided by (used in) operating activities |
|
$ |
79.1 |
|
|
$ |
(100.4 |
) |
|
|
|
|
|
|
|
Investing Activities
Net cash used in investing activities during the 2007 six months was approximately
$234.4 million, compared to net cash used in investing activities during the 2006 six months
of $126.9 million. The change was primarily due to the net purchases and sales of our
short-term and long-term investments during the respective six-month periods. In addition,
approximately $29.1 million was paid to Q-Med upon the FDAs approval of PERLANE®
during the second quarter of 2007, and $27.4 million was paid during the first quarter of
2006 for contingent payments related to our 2001 merger with Ascent.
Financing Activities
Net cash provided by financing activities during the 2007 six months was $13.6 million,
compared to net cash provided by financing activities of $3.2 million during the 2006 six
months. Proceeds from the exercise of stock options were $15.8 million during the 2007 six
months compared to $5.9 million during the 2006 six months. Dividends paid during the 2007
six months was $3.4 million, and dividends paid during the 2006 six months was $3.3 million.
Contingent Convertible Senior Notes and Other Long-Term Commitments
On August 14, 2003, we exchanged $230.8 million in principal amount of our Old Notes
for $283.9 million in principal amount of our 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 did not exchange will continue to be subject to the terms
of the Old Notes. See Note 10 of Notes to Condensed Consolidated Financial Statements for
further discussion.
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. Holders of the Old Notes had the option to require us to repurchase
all of a portion of their Old Notes on June 4, 2007 (extended to July 11, 2007). Holders of
$5,000 of outstanding principal amounts of the Old Notes exercised their right to require
the Company to purchase their Old Notes for cash. 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.
Except for the Old Notes, the New Notes and deferred tax liabilities, we had only $0.5
million of long-term liabilities and had only $98.6 million of current liabilities at June
30, 2007. 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
33
infrastructure. In addition, we will be implementing a new ERP system during 2007 and 2008, which will require
financial expenditures to complete.
We have made available to BioMarin Pharmaceutical Inc. (BioMarin) the ability to draw
down on a Convertible Note up to $25.0 million beginning July 1, 2005 (the Convertible
Note). The Convertible Note is convertible based on certain terms and conditions including
a change of control provision. Money advanced under the Convertible Note is convertible
into BioMarin shares at a strike price equal to the BioMarin average closing price for the
20 trading days prior to such advance. The Convertible Note matures on the option purchase
date in 2009 as defined in the securities purchase agreement entered into on May 18, 2004,
but may be repaid by BioMarin at any time prior to the option purchase date. As of August
9, 2007, BioMarin has not requested any monies to be advanced under the Convertible Note,
and no amounts are outstanding.
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash
dividends aggregating approximately $25.1 million on our common stock. In addition, on June
14, 2007, we declared a cash dividend of $0.03 per issued and outstanding share of common
stock payable on July 31, 2007 to our stockholders of record at the close of business on
July 2, 2007. 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.
Off-Balance Sheet Arrangements
As of June 30, 2007, we are not involved in any off-balance sheet arrangements, as
defined in Item 303(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, 2006. There were no
new significant accounting estimates in the second quarter of 2007, 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, 2006, with the exception of the adoption of FIN 48.
Recent Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which
clarifies the definition of fair value, establishes a framework for measuring fair value,
and expands the disclosures about fair value measurements. SFAS No. 157 is effective for
fiscal years beginning after November 15,
2007. We are currently evaluating SFAS No. 157 and its impact, if any, on our
consolidated results of operations and financial condition.
Effective January 1, 2007, we adopted FIN 48, Accounting for Uncertainty in Income
Taxes an interpretation of FASB Statement No. 109. FIN No. 48 provides guidance for the
recognition threshold and measurement attributes for financial statement recognition and
measurement of a tax position taken, or expected to be taken, in a tax return. In
accordance with FIN No. 48, we recognized a cumulative-effect
34
adjustment of approximately $808,000, increasing our liability for unrecognized tax benefits, interest, and penalties
and reducing the January 1, 2007 balance of retained earnings.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Statements and Financial Liabilities, which provides companies with an option to report
selected financial assets and liabilities at fair value. SFAS No. 159 requires companies to
provide additional information that will help investors and other users of financial
statements to more easily understand the effect of the companys choice to use fair value on
its earnings. It also requires entities to display the fair value of those assets and
liabilities for which the company has chosen to use fair value on the face of the balance
sheet. SFAS No. 159 does not eliminate disclosure requirements included in other accounting
standards, including requirements for disclosures about fair value measurements included in
FASB Statements No. 157, Fair Value Measurements, and No. 107, Disclosures about Fair Value
of Financial Instruments. We are currently evaluating SFAS No. 159 and its impact, if any,
on our consolidated results of operations and financial condition.
Forward-Looking Statements
This Quarterly Report on Form 10-Q and other documents we file with the SEC include
forward-looking statements. These include statements relating to future actions,
prospective products or product approvals, future performance or results of current and
anticipated products, sales and marketing efforts, expenses, the outcome of contingencies,
such as legal proceedings, and financial results. From time to time, we also may make
forward-looking statements in press releases or written statements, or in our communications
and discussions with investors and analysts in the normal course of business through
meetings, webcasts, phone calls, and conference calls. All statements other than statements
of historical fact are, or may be deemed to be, forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended (the Exchange Act). These statements are
based on certain assumptions made by us based on our experience and perception of historical
trends, current conditions, expected future developments and other factors we believe are
appropriate in the circumstances. We caution you that actual outcomes and results may
differ materially from what is expressed, implied, or forecast by our forward-looking
statements. Such statements are subject to a number of assumptions, risks and
uncertainties, many of which are beyond our control. You can identify these statements by
the fact that they do not relate strictly to historical or current facts. They use words
such as anticipate, estimate, expect, project, intend, plan, believe, will,
should, outlook, could, target, and other words and terms of similar meaning in
connection with any discussion of future operations or financial performance. Among the
factors that could cause actual results to differ materially from our forward-looking
statements are the following:
|
|
competitive developments affecting our products, such as the recent FDA approvals of
ARTEFILL®, RADIESSE®, ELEVESS, JUVEDERM
Ultra and JUVEDERM Ultra Plus, competitors to RESTYLANE®
and PERLANE®, a generic form of our DYNACIN® Tablets
product, generic forms of our LOPROX® TS and LOPROX® Cream
products, and potential generic forms of our LOPROX® Shampoo,
LOPROX® Gel, TRIAZ® or PLEXION® products; |
|
|
|
the success of research and development activities and 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.
For example, in the August 29, 2006 Federal Register, the FDA issued a notice of
proposed rulemaking to categorically
establish that over-the-counter skin bleaching drug products are not generally
recognized as safe and effective and are misbranded. If the proposed rule is adopted,
all manufacturers of skin bleaching products would be required to remove their products
from the market and obtain FDA approval prior to re-entering the U.S. market.
ESOTERICA® is an over-the-counter product line sold by the Company that
contains bleaching products that would be regulated by the proposed rule and, if that
occurs, the Company does not currently intend to invest in obtaining an approved NDA in
order to continue selling this product line. This product accounted for $2.0 million
and $1.0 million in net revenues during fiscal year 2006 and the 2007 six months,
respectively; |
35
|
|
changes in our product mix; |
|
|
|
changes in prescription levels; |
|
|
|
the effect of economic changes in hurricane-effected areas; |
|
|
|
manufacturing or supply interruptions; |
|
|
|
importation of other dermal filler 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; |
|
|
|
the ability to successfully market both new and existing products; |
|
|
|
difficulties or delays in manufacturing; |
|
|
|
the ability to compete against generic and other branded products; |
|
|
|
trends toward managed care and health care cost containment; |
|
|
|
our ability to protect our patents and other intellectual property; |
|
|
|
possible U.S. legislation or regulatory action affecting, among other things,
pharmaceutical pricing and reimbursement, including Medicaid and Medicare and
involuntary approval of prescription medicines for over-the-counter use; |
|
|
|
legal defense costs, insurance expenses, settlement costs and the risk of an
adverse decision or settlement related to product liability, patent protection,
government investigations, and other legal proceedings (see Part II, Item 1, Legal
Proceedings); |
|
|
|
changes in U.S. generally accepted accounting principles; |
|
|
|
additional costs related to compliance with changing regulation of corporate
governance and public financial disclosure; |
|
|
|
our ability to successfully design and implement our new enterprise resource
planning (ERP) system; |
|
|
|
any changes in business, political and economic conditions due to the threat of
future terrorist activity in the U.S. and other parts of the world; |
|
|
|
access to available and feasible financing on a timely basis; |
|
|
|
the availability of product acquisition or in-licensing opportunities; |
|
|
|
the risks and uncertainties normally incident to the pharmaceutical and medical
device industries, including product liability claims; |
|
|
|
the risks and uncertainties associated with obtaining necessary FDA approvals; |
|
|
|
the inability to obtain required regulatory approvals for any of our pipeline
products, such as RELOXIN®; |
|
|
|
unexpected costs and expenses, or our ability to limit costs and expenses as our
business continues to grow; and |
|
|
|
the impact of acquisitions, divestitures and other significant corporate
transactions. |
36
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, 2006 contains discussions of various
risks relating to our business that could cause actual results to differ materially from
expected and historical results, which is incorporated herein by reference and which you
should review. You should understand that it is not possible to predict or identify all
such risks. Consequently, you should not consider any such list or discussion to be a
complete set of all potential risks or uncertainties.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of June 30, 2007, 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,
2006.
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, 2007 and have concluded that, as of such date, our
disclosure controls and procedures were effective and designed 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 our 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 our 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, 2007, 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.
Part II. Other Information
Item 1. Legal Proceedings
On April 25, 2007, we entered into a Settlement Agreement with the Justice Department,
the Office of Inspector General of the Department of Health and Human Services (OIG) and
the TRICARE Management Activity (collectively, the United States) and private complainants
to settle all outstanding federal and state civil suits against us in connection with claims
related to our alleged off-label marketing and promotion of LOPROX® and
LOPROX® TS products to pediatricians during periods prior to our May 2004
disposition of our pediatric sales division (the Settlement Agreement). The settlement is
neither an
37
admission of liability by us nor a concession by the United States that its
claims are not well founded. Pursuant to the Settlement Agreement, we agreed to pay
approximately $10 million to settle the matter. Pursuant to the Settlement Agreement, the
United States released us from the claims asserted by the United States and agreed to
refrain from instituting action seeking exclusion from Medicare, Medicaid, the TRICARE
Program and other federal health care programs for the alleged conduct. These releases
relate solely to the allegations related to us and do not cover individuals. The Settlement
Agreement also provides that the private complainants release us and our officers, directors
and employees from the asserted claims, and we release the United States and the private
complainants from asserted claims.
As part of the settlement, we have entered into a five-year Corporate Integrity
Agreement (the CIA) with the OIG to resolve any potential administrative claims the OIG
may have arising out of the governments investigation. The CIA acknowledges the existence
of our comprehensive existing compliance program and provides for certain other
compliance-related activities during the term of the CIA, including the maintenance of a
compliance program that, among other things, is designed to ensure compliance with the CIA,
federal health care programs and FDA requirements. Pursuant to the CIA, we are required to
notify the OIG, in writing, of: (i) any ongoing government investigation or legal proceeding
involving an allegation that we have committed a crime or has engaged in fraudulent
activities; (ii) any other matter that a reasonable person would consider a probable
violation of applicable criminal, civil, or administrative laws; (iii) any written report,
correspondence, or communication to the FDA that materially discusses any unlawful or
improper promotion of our products; and (iv) any change in location, sale, closing,
purchase, or establishment of a new business unit or location related to items or services
that may be reimbursed by Federal health care programs. We are also subject to periodic
reporting and certification requirements attesting that the provisions of the CIA are being
implemented and followed, as well as certain document and record retention mandates. We
have hired a Chief Compliance Officer and created an enterprise-wide compliance function to
administer our obligations under the CIA.
On or about October 12, 2006, we and the United States Attorneys Office for the
District of Kansas entered into a Nonprosecution Agreement wherein the government agreed not
to prosecute us for any alleged criminal violations relating to the alleged off-label
marketing and promotion of LOPROX®. In exchange for the governments agreement
not to pursue any criminal charges against us, we agreed to continue cooperating with the
government in its ongoing investigation into whether past and present employees and officers
may have violated federal criminal law regarding alleged off-label marketing and promotion
of LOPROX® to pediatricians. Any such claims, prosecutions or other proceedings,
with respect to our past and present employees and officers, the cost of their defense and
fines and penalties resulting therefrom could have a material impact on our reputation,
business and financial condition.
On October 27, 2005, we filed suit against Upsher-Smith Laboratories, Inc. of Plymouth,
Minnesota and against Prasco Laboratories of Cincinnati, Ohio for infringement of Patent No.
6,905,675 entitled Sulfur Containing Dermatological Compositions and Methods for Reducing
Malodors in Dermatological Compositions covering our sodium sulfacetamide/sulfur
technology. This intellectual property is related to our PLEXION® Cleanser
product. The suit was filed in the U.S. District Court for the District of Arizona, and
seeks an award of damages, as well as a preliminary and a permanent injunction. A hearing
on our preliminary injunction motion was heard on March 8 and March 9, 2006. On May 2,
2006, an order denying the motion for a preliminary injunction was received by Medicis. The
Court has entered an order staying the case until the conclusion of a patent
reexamination request submitted by Medicis.
On June 22, 2006, Medicis and Aventis-Sanofi (the manufacturer of LOPROX®
Gel), filed a complaint in the U.S. District Court for the District of Minnesota against
Paddock Laboratories, asserting that Paddocks proposed generic version of Medicis
LOPROX® Gel product will infringe one or more claims of one of the Companys
patents on LOPROX® Gel. Paddock filed an answer and counterclaims and later
amended these filings, denying infringement and seeking fees and costs. On December 7,
2006, plaintiffs served Paddock with a covenant not to sue for infringement of the 656
patent based on the products that are the subject of Paddocks current ANDA, and filed their
reply to Paddocks counterclaims, which included a denial of Paddocks allegations that the
337 patent claims are invalid, unenforceable and not infringed. On January 26, 2007, the
Court entered a stipulated Amended Pretrial Scheduling Order, extending all pre-trial and
discovery dates in the case by 30 days to allow the parties to engage in
38
discussions. On
March 14, 2007, the Court entered a further Order extending dates in the case to permit the
parties to engage in discussions.
In addition to the matters discussed above, we and certain of our subsidiaries are
parties to other actions and proceedings incident to our business, including litigation
regarding our intellectual property, challenges to the enforceability or validity of our
intellectual property and claims that our products infringe on the intellectual property
rights of others. We record contingent liabilities resulting from claims against us when it
is probable (as that word is defined in Statement of Financial Accounting Standards No. 5)
that a liability has been incurred and the amount of the loss is reasonably estimable. We
disclose material contingent liabilities when there is a reasonable possibility that the
ultimate loss will exceed the recorded liability. Estimating probable losses requires
analysis of multiple factors, in some cases including judgments about the potential actions
of third-party claimants and courts. Therefore, actual losses in any future period are
inherently uncertain. In all of the cases noted where we are the defendant, we believe we
have meritorious defenses to the claims in these actions and that resolution of these
matters will not have a material adverse effect on our business, financial condition, or
results of operations; however, the results of the proceedings are uncertain, and there can
be no assurance to that effect.
Item 1A. Risk Factors
There are no material changes from the risk factors previously disclosed in Part I of
Item 1A in our Annual Report on Form 10-K for the year ended December 31, 2006.
39
Item 4. Submission of Matters to a Vote of Security Holders
On May 22, 2007, the Company held its 2007 Annual Meeting of Stockholders (the Annual
Meeting). The holders of 51,207,924 shares of Class A Common Stock were present in person
or represented by proxy at the meeting. The following is a summary of the results of the
voting by the Companys stockholders at the Annual Meeting:
1) Election of Directors
|
|
The stockholders elected the following persons to serve as directors of the Company
for a term of three years, or until their successors are duly elected and qualified
or until their earlier resignation or removal. Votes were cast as follows: |
|
|
|
|
|
|
|
|
|
|
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Number of Votes |
|
|
For |
|
Withheld |
Jonah Shacknai |
|
|
46,005,475 |
|
|
|
5,202,449 |
|
Michael A. Pietrangelo |
|
|
41,124,007 |
|
|
|
10,083,917 |
|
Lottie H. Shackelford |
|
|
46,013,265 |
|
|
|
5,194,659 |
|
|
|
The directors of the Company whose terms of office continued were Mr. Arthur G.
Altschul, Jr., Mr. Spencer Davidson, Mr. Stuart Diamond, Mr. Peter S. Knight, Esq.
and Mr. Philip S. Schein, M.D. |
|
2) |
|
The stockholders approved an amendment to the Medicis 2006 Incentive Award
Plan, increasing the number of shares of common stock reserved for issuance under the
plan by 2,500,000 shares. Votes were cast as follows: |
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
Broker Non-Vote |
31,856,625
|
|
14,671,069
|
|
282,623
|
|
4,397,607 |
3) |
|
The stockholders approved the appointment of Ernst & Young LLP as independent
auditors for the fiscal year ending December 31, 2007. Votes were cast as follows: |
|
|
|
|
|
|
|
For |
|
Against |
|
Abstain |
|
|
51,100,242
|
|
44,283
|
|
63,399
|
|
|
40
Item 6. Exhibits
|
|
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Exhibit 3.1
|
|
Certificate of Incorporation of the Company, as amended (1) |
|
|
|
Exhibit 3.2
|
|
Amended and Restated By-Laws of Medicis Pharmaceutical Corporation (2) |
|
|
|
Exhibit 10.1
|
|
Amendment No. 3 to the Medicis 2006 Incentive Award Plan (3) |
|
|
|
Exhibit 31.1+
|
|
Certification by the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
|
|
|
Exhibit 31.2+
|
|
Certification by the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
|
|
|
Exhibit 32.1++
|
|
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 |
|
|
|
+ |
|
Filed herewith
++ Furnished herewith |
|
(1) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the
fiscal year ended June 30, 2004, filed with the SEC on September 10, 2004. |
|
(2) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed
with the SEC on April 16, 2007. |
|
(3) |
|
Incorporated by reference to Appendix A of the Companys Definitive Proxy
Statement on Schedule 14A filed with the SEC on April 16, 2007. |
41
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.
|
|
|
|
|
|
MEDICIS PHARMACEUTICAL CORPORATION |
|
|
Date: August 9, 2007 |
By: |
/s/ Jonah Shacknai
|
|
|
|
Jonah Shacknai |
|
|
|
Chairman of the Board and
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Date: August 9, 2007 |
By: |
/s/ Mark A. Prygocki, Sr.
|
|
|
|
Mark A. Prygocki, Sr. |
|
|
|
Executive Vice President
Chief Financial Officer and Treasurer
(Principal Financial and Accounting
Officer) |
|
42