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, 2006
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 |
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(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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Outstanding at August 3, 2006 |
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Class A Common Stock $.014 Par Value
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54,723,359 |
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, 2006 |
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December 31, 2005 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
|
$ |
223,071 |
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$ |
446,997 |
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Short-term investments |
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393,068 |
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295,535 |
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Accounts receivable, net |
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48,327 |
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46,697 |
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Inventories, net |
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19,100 |
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19,076 |
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Deferred tax assets, net |
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14,966 |
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12,738 |
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Other current assets |
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14,379 |
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12,241 |
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Total current assets |
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712,911 |
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833,284 |
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Property and equipment, net |
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4,726 |
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5,416 |
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Intangible assets: |
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Intangible assets related to product line
acquisitions and business combinations |
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311,406 |
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311,406 |
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Other intangible assets |
|
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5,477 |
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|
4,888 |
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|
|
|
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316,883 |
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316,294 |
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Less: accumulated amortization |
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86,710 |
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76,458 |
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Net intangible assets |
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230,173 |
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239,836 |
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Goodwill |
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63,107 |
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63,094 |
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Deferred tax assets, net |
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29,602 |
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Long-term investments |
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2,222 |
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Deferred financing costs, net |
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3,253 |
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4,325 |
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|
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|
|
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$ |
1,045,994 |
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$ |
1,145,955 |
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|
|
|
|
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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, 2006 |
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December 31, 2005 |
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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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$ |
60,491 |
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$ |
57,708 |
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Short-term contract obligation |
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27,407 |
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Income taxes payable |
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9,798 |
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31,521 |
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Other current liabilities |
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33,863 |
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24,195 |
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Total current liabilities |
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104,152 |
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140,831 |
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Long-term liabilities: |
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Contingent convertible senior notes |
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453,065 |
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|
453,065 |
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Deferred tax liability, net |
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8,572 |
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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: 67,350,440 and 67,052,326 at
June 30, 2006 and December 31, 2005,
respectively |
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943 |
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|
938 |
|
Class B common stock, $0.014 par value; shares
authorized: 1,000,000; no shares issued and
outstanding at June 30, 2006 and December 31, 2005 |
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Additional paid-in capital |
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571,509 |
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550,006 |
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Accumulated other comprehensive income |
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|
474 |
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|
379 |
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Accumulated earnings |
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258,581 |
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334,894 |
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Less: Treasury stock, 12,651,554 and 12,647,554
shares at cost at June 30, 2006 and December 31,
2005, respectively |
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(342,730 |
) |
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|
(342,730 |
) |
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Total stockholders equity |
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488,777 |
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543,487 |
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$ |
1,045,994 |
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$ |
1,145,955 |
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|
|
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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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2006 |
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2005 |
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2006 |
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2005 |
|
Net product revenues |
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$ |
80,646 |
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$ |
82,328 |
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$ |
151,733 |
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$ |
158,115 |
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Net contract revenues |
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4,386 |
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18,216 |
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8,456 |
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37,617 |
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Net revenues |
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85,032 |
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|
100,544 |
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|
160,189 |
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|
195,732 |
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Cost of product revenue (1) |
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9,419 |
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|
14,262 |
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|
21,598 |
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28,177 |
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Gross profit |
|
|
75,613 |
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86,282 |
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|
138,591 |
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|
167,555 |
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Operating expenses: |
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Selling, general and administrative (2) |
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51,065 |
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|
37,484 |
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102,288 |
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|
69,418 |
|
Research and development (3) |
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43,767 |
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6,085 |
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|
|
140,985 |
|
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|
20,536 |
|
Depreciation and amortization |
|
|
5,800 |
|
|
|
6,074 |
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|
|
11,656 |
|
|
|
12,128 |
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|
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Operating (loss) income |
|
|
(25,019 |
) |
|
|
36,639 |
|
|
|
(116,338 |
) |
|
|
65,473 |
|
|
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|
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|
|
|
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Interest income |
|
|
7,262 |
|
|
|
3,405 |
|
|
|
14,283 |
|
|
|
6,394 |
|
Interest expense |
|
|
(2,658 |
) |
|
|
(2,658 |
) |
|
|
(5,316 |
) |
|
|
(5,316 |
) |
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|
(Loss) income before income tax expense |
|
|
(20,415 |
) |
|
|
37,386 |
|
|
|
(107,371 |
) |
|
|
66,551 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Income tax (benefit) expense |
|
|
(35,934 |
) |
|
|
12,991 |
|
|
|
(34,347 |
) |
|
|
22,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
|
|
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|
Net income (loss) |
|
$ |
15,519 |
|
|
$ |
24,395 |
|
|
$ |
(73,024 |
) |
|
$ |
43,766 |
|
|
|
|
|
|
|
|
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|
|
|
|
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|
|
|
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|
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|
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|
Basic net income (loss) per share |
|
$ |
0.28 |
|
|
$ |
0.45 |
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|
$ |
(1.34 |
) |
|
$ |
0.81 |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
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|
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|
Diluted net income (loss) per share |
|
$ |
0.25 |
|
|
$ |
0.38 |
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|
$ |
(1.34 |
) |
|
$ |
0.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Cash dividend declared per common share |
|
$ |
0.03 |
|
|
$ |
0.03 |
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Basic common shares outstanding |
|
|
54,501 |
|
|
|
54,264 |
|
|
|
54,429 |
|
|
|
54,257 |
|
|
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
69,733 |
|
|
|
68,914 |
|
|
|
54,429 |
|
|
|
69,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) amounts exclude amortization of
intangible assets related to acquired
products |
|
$ |
5,075 |
|
|
$ |
5,345 |
|
|
$ |
10,150 |
|
|
$ |
10,686 |
|
(2) amounts include share-based
compensation expense |
|
$ |
6,835 |
|
|
$ |
129 |
|
|
$ |
13,482 |
|
|
$ |
258 |
|
(3) amounts include share-based
compensation expense |
|
$ |
505 |
|
|
$ |
|
|
|
$ |
1,038 |
|
|
$ |
|
|
See accompanying notes to condensed consolidated financial statements.
5
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2006 |
|
|
June 30, 2005 |
|
Operating Activities: |
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(73,024 |
) |
|
$ |
43,766 |
|
Adjustments to reconcile net (loss) income to
net cash provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
11,656 |
|
|
|
12,128 |
|
Amortization of deferred financing fees |
|
|
1,072 |
|
|
|
1,072 |
|
Loss on disposal of property and equipment |
|
|
9 |
|
|
|
12 |
|
(Gain) loss on sale of available-for-sale investments |
|
|
(227 |
) |
|
|
778 |
|
Share-based compensation expense |
|
|
14,521 |
|
|
|
258 |
|
Deferred income tax (benefit) expense |
|
|
(40,402 |
) |
|
|
8,429 |
|
Tax benefit from exercise of stock options |
|
|
1,039 |
|
|
|
46 |
|
Excess tax benefits from share-based payment arrangements |
|
|
(563 |
) |
|
|
|
|
Provision for doubtful accounts and returns |
|
|
1,618 |
|
|
|
996 |
|
(Amortization) accretion of (discount)/premium on investments |
|
|
(1,452 |
) |
|
|
1,519 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(3,247 |
) |
|
|
(2,500 |
) |
Inventories |
|
|
(25 |
) |
|
|
(3,781 |
) |
Other current assets |
|
|
(2,138 |
) |
|
|
3,828 |
|
Accounts payable |
|
|
2,784 |
|
|
|
11,022 |
|
Income taxes payable |
|
|
(21,723 |
) |
|
|
3,550 |
|
Other current liabilities |
|
|
9,657 |
|
|
|
3,393 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by operating activities |
|
|
(100,445 |
) |
|
|
84,516 |
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(723 |
) |
|
|
(1,084 |
) |
Payment of direct merger costs |
|
|
(27,420 |
) |
|
|
(7,325 |
) |
Payments for purchase of product rights |
|
|
(588 |
) |
|
|
(211 |
) |
Purchase of available-for-sale investments |
|
|
(388,865 |
) |
|
|
(321,959 |
) |
Sale of available-for-sale investments |
|
|
169,123 |
|
|
|
356,792 |
|
Maturity of available-for-sale investments |
|
|
121,620 |
|
|
|
38,116 |
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(126,853 |
) |
|
|
64,329 |
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
Payment of dividends |
|
|
(3,278 |
) |
|
|
(3,255 |
) |
Excess tax benefits from share-based payment arrangements |
|
|
563 |
|
|
|
|
|
Proceeds from the exercise of stock options |
|
|
5,948 |
|
|
|
909 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
3,233 |
|
|
|
(2,346 |
) |
|
|
|
|
|
|
|
|
|
Effect of exchange rate on cash and cash equivalents |
|
|
139 |
|
|
|
(235 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(223,926 |
) |
|
|
146,264 |
|
Cash and cash equivalents at beginning of period |
|
|
446,997 |
|
|
|
31,521 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
223,071 |
|
|
$ |
177,785 |
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
6
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2006
(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 including
acne, fungal infections, rosacea, hyperpigmentation, photoaging, psoriasis, eczema, skin and
skin-structure infections, seborrheic dermatitis and cosmesis (improvement in the texture
and appearance of skin). Medicis currently offers 16 branded products. Its core brands are
DYNACIN® (minocycline HCl), LOPROX® (ciclopirox), OMNICEF®
(cefdinir), PLEXION® (sodium sulfacetamide/sulfur), RESTYLANE®
(hyaluronic acid), SOLODYN (minocycline HCl, USP) Extended Release Tablets,
TRIAZ® (benzoyl peroxide), and VANOS (fluocinonide) Cream, 0.1%.
In March 2003, Medicis expanded into the dermal aesthetic market through its
acquisition of the exclusive U.S. and Canadian rights to market, distribute and
commercialize the dermal restorative product lines known as RESTYLANE®,
PERLANE® and RESTYLANE FINE LINES from Q-Med AB, a Swedish
biotechnology/medical device company and its affiliates, collectively Q-Med.
RESTYLANE® has been approved by the Food and Drug Administration (the FDA) for
use in the U.S. as a medical device for the correction of moderate to severe facial wrinkles
and folds, such as nasolabial folds. RESTYLANE®, PERLANE® and
RESTYLANE FINE LINES have been approved for use in Canada.
On March 17, 2006, Medicis 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 product in the U.S., Canada and Japan for aesthetic
use by physicians. The product is commonly referred to as RELOXIN® in the U.S.
aesthetic market and DYSPORT® for medical and aesthetic markets outside the U.S.
The product is not currently approved for use in the U.S., Canada or Japan.
The consolidated financial statements include the accounts of Medicis Pharmaceutical
Corporation 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 Transition Report on Form
10-K/T for the six-month period ended December 31, 2005 (the Transition Period). 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 Transition Report on Form 10-K/T for
the Transition Period. Certain prior period amounts have been reclassified to conform with
current period presentation.
7
2. SHARE-BASED COMPENSATION
At June 30, 2006, the Company had seven active share-based employee compensation plans.
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. Results for prior
periods have not been restated.
The adoption of SFAS No. 123R increased the loss before income tax expense for the
three months and six months ended June 30, 2006 by approximately $7.3 million and $14.5
million, respectively, and decreased net income for the three months ended June 30, 2006 by
approximately $5.3 million and increased the net loss for the six months ended June 30, 2006
by approximately $10.5 million. As a result, basic and diluted net income per common share
for the three months ended June 30, 2006 were reduced $0.10 and $0.08, respectively, and the
net loss per common share for the six months ended June 30, 2006 was increased $0.19.
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, 2006, total unrecognized compensation
cost related to stock option awards, to be recognized as expense subsequent to June 30,
2006, was approximately $50.8 million and the related weighted-average period over which it
is expected to be recognized is approximately 2.6 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 $0.6 million of excess tax benefits were recognized during the three
months and six months ended June 30, 2006.
A summary of stock options activity within the Companys stock-based compensation plans
and changes for the six months ended June 30, 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
Balance at December 31, 2005 |
|
|
14,379,336 |
|
|
$ |
27.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
38,625 |
|
|
$ |
30.05 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(294,114 |
) |
|
$ |
20.23 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(186,385 |
) |
|
$ |
30.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
|
13,937,462 |
|
|
$ |
27.32 |
|
|
|
6.02 |
|
|
$ |
27,326,908 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during the six months ended June 30, 2006 was
$3,389,610. Options exercisable under the Companys share-based compensation plans at June
30, 2006 were 7,072,638, with an average exercise price of $24.42, an average remaining
contractual term of 4.9 years, and an aggregate intrinsic value of $20,284,870.
8
A summary of fully vested stock options and stock options expected to vest, based on
historical forfeiture rates, as of June 30, 2006, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Outstanding |
|
|
13,412,267 |
|
|
$ |
27.30 |
|
|
|
6.0 |
|
|
$ |
26,451,668 |
|
Exercisable |
|
|
6,855,550 |
|
|
$ |
24.41 |
|
|
|
4.9 |
|
|
$ |
19,766,765 |
|
The fair value of each stock option award is estimated on the date of the grant using
the Black-Scholes option pricing model. The fair value of stock option awards granted
during the six months ended June 30, 2006 and June 30, 2005 were estimated with the
following assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
Six Months Ended |
|
|
June 30, 2006 |
|
June 30, 2005 |
Expected dividend yield |
|
|
0.4 |
% |
|
|
0.3 |
% |
Expected stock price volatility |
|
|
0.36 |
|
|
|
0.44 |
|
Risk-free interest rate |
|
|
4.5 |
% |
|
|
3.6 |
% |
Expected life of options |
|
7 Years |
|
5 Years |
The expected dividend yield is based on expected annual dividends to be paid by the
Company as a percentage of the market value of the Companys stock as of the date of grant.
The Company determined that a blend of implied volatility and historical volatility is more
reflective of market conditions and a better indicator of expected volatility than using
purely historical volatility. The risk-free interest rate is based on the U.S. treasury
security rate in effect as of the date of grant. The expected lives of options are based on
historical data of the Company.
The weighted average fair value of stock options granted during the six months ended
June 30, 2006 was $13.36. There were no stock options granted during the six months ended
June 30, 2005.
The following table illustrates the effect on net income and net income per common
share as if the Company had applied the fair value recognition provisions of SFAS No. 123 to
all outstanding stock option awards for periods presented prior to the Companys July 1,
2005, adoption of SFAS No. 123R (amounts in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS |
|
|
SIX MONTHS |
|
|
|
ENDED |
|
|
ENDED |
|
|
|
JUNE 30, |
|
|
JUNE 30, |
|
|
|
2005 |
|
|
2005 |
|
Net income, as reported |
|
$ |
24,395 |
|
|
$ |
43,766 |
|
Deduct: Total stock-based employee
compensation expense determined under
fair value based method for all awards,
net of related tax effects |
|
|
6,569 |
|
|
|
11,618 |
|
|
|
|
|
|
|
|
Pro-forma net income |
|
$ |
17,826 |
|
|
$ |
32,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
Basic, as reported |
|
$ |
0.45 |
|
|
$ |
0.81 |
|
Basic, pro forma |
|
$ |
0.33 |
|
|
$ |
0.59 |
|
Diluted, as reported |
|
$ |
0.38 |
|
|
$ |
0.68 |
|
Diluted, pro forma |
|
$ |
0.28 |
|
|
$ |
0.51 |
|
9
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, 2006, 110,025
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, 2006, was approximately $0.6 million and $1.0 million, respectively.
Share-based compensation expense related to all restricted stock awards outstanding during
the three months and six months ended June 30, 2005, was approximately $0.1 million and $0.3
million, respectively. As of June 30, 2006, the total amount of unrecognized compensation
cost related to nonvested restricted stock awards, to be recognized as expense subsequent to
June 30, 2006, was approximately $7.0 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, 2006 is as follows (amounts in
thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
Nonvested Shares |
|
Shares |
|
|
Fair Value |
|
Nonvested at December 31, 2005 |
|
|
212,260 |
|
|
$ |
29.65 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
110,025 |
|
|
$ |
30.05 |
|
Vested |
|
|
(4,000 |
) |
|
$ |
23.30 |
|
Forfeited |
|
|
(1,300 |
) |
|
$ |
31.87 |
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2006 |
|
|
316,985 |
|
|
$ |
29.86 |
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the six months ended June 30,
2006 was approximately $0.1 million. No restricted shares vested during the six months
ended June 30, 2005.
|
|
|
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. In contrast, 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 or that the product will gain regulatory approval, the
Company expenses such payments.
On January 28, 2005, the Company amended its strategic alliance with AAIPharma Inc.
(AAIPharma) previously initiated in June 2002 for the development, commercialization and
license of a dermatologic product. The consummation of the amendment has not affected the
timing of the
development project. The amendment allowed for the immediate transfer of the work product,
as defined under the agreement, as well as the work products management and development, to
Medicis, and provides that AAIPharma will continue to assist Medicis with the development of
the product on a fee for
10
services basis. Medicis will have no future financial obligations
to pay AAIPharma on the attainment of clinical milestones, but incurred approximately $8.3
million as a charge to research and development expense during the three months ended March
31, 2005, as part of the amendment and the assumption of all liabilities associated with the
project.
|
|
|
4. |
|
DEVELOPMENT AND DISTRIBUTION AGREEMENT WITH IPSEN FOR RIGHTS TO IPSENS
BOTULINUM TOXIN PRODUCT KNOWN AS RELOXIN® |
On March 17, 2006, the Company entered into a development and distribution agreement
with Ipsen, whereby Ipsen granted Aesthetica Ltd., a wholly-owned subsidiary of Medicis,
rights to develop, distribute and commercialize Ipsens botulinum toxin 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. Upon execution of the development and distribution
agreement, 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, Medicis was obligated to make an additional $35.1
million payment, as amended, 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. At June 30, 2006,
the $22.2 million payment is included in accounts payable in the accompanying condensed
consolidated balance sheets.
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 (including the $12.9 million amount that was paid in April 2006) 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 September
2019. 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 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. |
|
MERGER OF ASCENT PEDIATRICS, INC. |
As part of its merger with Ascent completed in November 2001, the Company may be
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. From time to time the Company assesses the probability and
likelihood of payment in the coming respective November period based on current sales
trends. A total of approximately $27.4 million was included in short-term contract
obligation in the Companys condensed consolidated balance sheets as of December 31, 2005,
representing the first four years Contingent Payments. Pursuant to the merger agreement,
payment of the contingent portion of the purchase price was withheld pending the final
outcome of certain pending
litigation. The Company distributed the accumulated $27.4 million in 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
11
was initiated in March 2006, relating
to the concluded lawsuit. A $1.8 million settlement was recognized as a charge to selling,
general and administrative expense during the three months ended March 31, 2006.
6. SHORT-TERM AND LONG-TERM INVESTMENTS
The Companys short-term and long-term investments are intended to establish a
high-quality portfolio that preserves principal, meets liquidity needs, avoids inappropriate
concentrations and delivers an appropriate yield in relationship to the Companys investment
guidelines and market conditions. Short-term and long-term investments consist of corporate
and various government agency and municipal debt securities. Management classifies the
Companys short-term and long-term investments as available-for-sale. Available-for-sale
securities are carried at fair value with unrealized gains and losses reported in
stockholders equity. Realized gains and losses and declines in value judged to be other
than temporary, if any, are included in operations. A decline in the market value of any
available-for-sale security below cost that is deemed to be other than temporary, results in
an impairment in the fair value of the investment. The impairment is charged to earnings
and a new cost basis for the security is established. Premiums and discounts are amortized
or accreted over the life of the related available-for-sale security. Dividends and
interest income are recognized when earned. The cost of securities sold is calculated using
the specific identification method. At June 30, 2006, the Company has recorded the
estimated fair value in available-for-sale securities for short-term and long-term
investments of approximately $393.1 million and $2.2 million, respectively. The following
is a summary of available-for-sale securities (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
JUNE 30, 2006 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
U.S. corporate securities |
|
$ |
218,864 |
|
|
$ |
12 |
|
|
$ |
481 |
|
|
$ |
218,395 |
|
Other debt securities |
|
|
177,096 |
|
|
|
1 |
|
|
|
202 |
|
|
|
176,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
395,960 |
|
|
$ |
13 |
|
|
$ |
683 |
|
|
$ |
395,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three months and six months ended June 30, 2006, the gross realized gains on
sales of available-for-sale securities totaled $229,121 and $230,579 respectively, while
gross realized losses on sales of available-for-sale securities were immaterial for the
three months and six months ended June 30, 2006. 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, 2006, on available-for-sale
securities included in stockholders equity totaled $1,156,773 and $43,890, respectively.
The amortized cost and estimated fair value of the available-for-sale securities at June 30,
2006, by maturity, are shown below (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
JUNE 30, 2006 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
292,882 |
|
|
$ |
295,455 |
|
Due after one year through five years |
|
|
12,190 |
|
|
|
12,115 |
|
Due after
five years through 10 years |
|
|
3,370 |
|
|
|
3,370 |
|
Due after 10 years |
|
|
84,350 |
|
|
|
84,350 |
|
|
|
|
|
|
|
|
|
|
$ |
392,792 |
|
|
$ |
395,290 |
|
|
|
|
|
|
|
|
At June 30, 2006, approximately $97.6 million of the $99.8 million in estimated fair
value expected to mature greater than one year has been classified as short-term investments
since these investments are in an unrealized gain position. 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.
12
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, 2006 (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 |
|
$ |
187,665 |
|
|
$ |
377 |
|
|
$ |
21,745 |
|
|
$ |
104 |
|
Other debt securities |
|
|
73,909 |
|
|
|
117 |
|
|
|
15,266 |
|
|
|
84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
261,574 |
|
|
$ |
494 |
|
|
$ |
37,011 |
|
|
$ |
188 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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. Because the Company has the ability to 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, 2006.
7. SEGMENT AND PRODUCT INFORMATION
The Company operates in one significant business segment: Pharmaceuticals. The
Companys current pharmaceutical franchises are divided between the dermatological and
non-dermatological fields. The dermatological field represents products for the treatment
of acne and acne-related dermatological conditions and non-acne dermatological conditions.
The non-dermatological field represents products for the treatment of urea cycle disorder
and contract revenue. The acne and acne-related dermatological product lines include core
brands DYNACIN®, PLEXION®, SOLODYNTM and
TRIAZ®. The non-acne dermatological product lines include core brands
LOPROX®, OMNICEF®, 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. All products, with the exception of
BUPHENYL®, are sold primarily to wholesalers and retail chain drug stores.
BUPHENYL® is primarily sold directly to hospitals and pharmacies.
The percentage of net revenues for each of the product categories is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED |
|
|
SIX MONTHS ENDED |
|
|
|
JUNE 30, |
|
|
JUNE 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
Acne and acne-related
dermatological products |
|
|
43 |
% |
|
|
28 |
% |
|
|
31 |
% |
|
|
26 |
% |
Non-acne dermatological products |
|
|
48 |
|
|
|
49 |
|
|
|
57 |
|
|
|
50 |
|
Non-dermatological products |
|
|
9 |
|
|
|
23 |
|
|
|
12 |
|
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
8. 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
13
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.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 |
|
|
December 31, 2005 |
|
Raw materials |
|
$ |
5,462 |
|
|
$ |
6,436 |
|
Finished goods |
|
|
14,531 |
|
|
|
13,925 |
|
Valuation reserve |
|
|
(893 |
) |
|
|
(1,285 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
19,100 |
|
|
$ |
19,076 |
|
|
|
|
|
|
|
|
9. CONTINGENT CONVERTIBLE SENIOR NOTES
In June 2002, the Company sold $400.0 million aggregate principal amount of its 2.5%
Contingent Convertible 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, 2012 and 2017; and upon a change in control, as defined in the indenture
governing the Old Notes, at 100% of the principal amount of the Old Notes, plus accrued and
unpaid interest to the date of the repurchase, payable in cash.
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 is amortizing these costs over the five-year Put
period, which runs through May 2007. The Put period runs from the date the Old Notes were
issued to the date the Company may redeem some or all of the Old Notes.
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 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. The Put period runs from the date the New Notes
were issued to the date the Company may redeem some or all of the New Notes.
15
During the quarters ended 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 stock closing
above $31.96 on 20 of the last 30 trading days and the last trading day of the quarters
ended 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, 2006. During the quarters ended 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 all future quarters, 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 September 30, 2004 and March 31, 2004,
outstanding principal amounts of $2,000 and $6,000 of Old Notes, respectively, were
converted into shares of the Companys Class A common stock. As of August 9, 2006, no other
Old Notes had been converted.
10. 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.
The benefit for income taxes for the three months ended June 30, 2006, includes a $5.1
million tax benefit relating to the resolution of certain income tax examinations for tax
years ended through June 30, 2004.
At June 30, 2006, the Company has a federal net operating loss carryforward of
approximately $61.7 million that begins expiring 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 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. Based upon this
limitation, the Company estimates that approximately $15.2 million of the $61.7 million net
operating loss carryforward will be realized. Accordingly, a valuation reserve has been
recorded for the remaining net operating loss carryforward that is not expected to be
realized.
At June 30, 2006, the Company had a research and development credit carryforward of
approximately $1.3 million that begins expiring in varying amounts in the years 2008 through
2020 if not previously utilized. All of the research and development credit carryforward
was acquired in connection with the Companys merger with Ascent during fiscal 2002 and is
subject to the limitation under Internal Revenue Code Section 383. As a result of this
limitation, the Company does not expect to realize any of
the research and development credits acquired from Ascent. Accordingly, a valuation reserve
of $1.3 million has been established for the acquired research and development credits.
As a result of the limitations described above, the Company recorded a deferred tax
asset valuation allowance of $17.5 million related to the net operating loss and research
and development credit carryforwards acquired in the merger with Ascent. Subsequent
realization of loss and credit carryforwards in excess of the amounts estimated to be
realized as of June 30, 2006 will be applied to reduce the valuation allowance and goodwill
recorded in connection with the merger with Ascent.
16
The Company took advantage of additional tax deductions available relating to the
exercise of non-qualified stock options, disqualified dispositions of incentive stock
options and vesting of restricted shares. Accordingly, the Company recorded a $1.0 million
increase to equity and a $1.0 million reduction to taxes payable for the three and six
months ended June 30, 2006. Quarterly adjustments for the exercise of non-qualified stock
options, disqualified dispositions of incentive stock options, and vesting of restricted
shares may vary as they relate to the actions of the option holder or shareholder.
During the three months ended June 30, 2006 and June 30, 2005, the Company made net tax
payments of $6.0 million and $2.6 million, respectively.
11. DIVIDENDS DECLARED ON COMMON STOCK
On June 14, 2006, the Company declared a cash dividend of $0.03 per issued and
outstanding share of its Class A common stock payable on July 31, 2006 to stockholders of
record at the close of business on July 3, 2006. The $1.6 million dividend was recorded as
a reduction of accumulated earnings and is included in other current liabilities in the
accompanying condensed consolidated balance sheets as of June 30, 2006.
12. 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 (loss) for the three
months and six months ended June 30, 2006 was $14.5 million and $(72.9) million,
respectively. Total comprehensive income for the three months and six months ended June 30,
2005 was $25.0 million and $43.6 million, respectively.
17
13. 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, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
15,519 |
|
|
$ |
24,395 |
|
|
$ |
(73,024 |
) |
|
$ |
43,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
54,501 |
|
|
|
54,264 |
|
|
|
54,429 |
|
|
|
54,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss)
per common share |
|
$ |
0.28 |
|
|
$ |
0.45 |
|
|
$ |
(1.34 |
) |
|
$ |
0.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
15,519 |
|
|
$ |
24,395 |
|
|
$ |
(73,024 |
) |
|
$ |
43,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest
expense and
issue costs related to
Old Notes |
|
|
836 |
|
|
|
836 |
|
|
|
|
|
|
|
1,672 |
|
Tax-effected interest
expense and
issue costs related to
New Notes |
|
|
839 |
|
|
|
839 |
|
|
|
|
|
|
|
1,677 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) assuming
dilution |
|
$ |
17,194 |
|
|
$ |
26,070 |
|
|
$ |
(73,024 |
) |
|
$ |
47,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares |
|
|
54,501 |
|
|
|
54,264 |
|
|
|
54,429 |
|
|
|
54,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
2,084 |
|
|
|
1,502 |
|
|
|
|
|
|
|
1,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares assuming dilution |
|
|
69,733 |
|
|
|
68,914 |
|
|
|
54,429 |
|
|
|
69,361 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss)
per common share |
|
$ |
0.25 |
|
|
$ |
0.38 |
|
|
$ |
(1.34 |
) |
|
$ |
0.68 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 months 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 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.
18
The diluted net income per common share computation for the three months and six months
ended June 30, 2005 excludes 5,620,025 and 2,801,800 shares of stock, respectively, that
represented outstanding stock options whose exercise price were greater than the average
market price of the common shares during the period and were anti-dilutive.
14. CONTINGENCIES
The government notified the Company on December 14, 2004, that it is investigating
claims that the Company violated the federal False Claims Act. The Company is fully
cooperating with the government in its investigation, which relates to the Companys
marketing and promotion of LOPROX® products to pediatricians prior to the
Companys May 2004 disposition of the Companys pediatric sales division. In April 2006,
the Company offered $6.0 million to resolve the governments civil claims contingent on the
execution of appropriate releases. The Justice Department countered with a demand of $12.8
million to resolve the civil claims that the government is prepared to pursue. In May 2006,
the Company countered with an offer of $8.0 million that was contingent on resolving other
aspects of the governments investigation to the satisfaction of the Company. In June 2006,
the Justice Department countered with a tentative demand of $10.0 million. The Company is
continuing to hold settlement discussions with the government in an effort to resolve their
claims, and these discussions may or may not result in a monetary settlement with the
government. Accordingly, the Company has accrued a loss contingency of $8.0 million as of
June 30, 2006, related to this matter, of which $6.0 million was recorded during the three
months ended March 31, 2006, and $2.0 million was recorded during the three months ended
June 30, 2006. This loss contingency is included in other current liabilities as of June
30, 2006 in the accompanying condensed consolidated balance sheets, and is included in
selling, general and administrative expenses for the six months ended June 30, 2006 in the
accompanying condensed consolidated statements of income.
In addition, the Company has been notified by the United States Attorneys Office in
Topeka, Kansas that the United States Attorney is investigating whether past and present
employees and officers may have violated federal law regarding alleged off-label promotion
in the marketing and promotion of LOPROX® and LOPROX® TS to
pediatricians. No individuals have been designated as targets of the investigation. The
Company continues to cooperate with the government. Any such claims,
prosecutions or other proceedings, with respect to the Company's past
and present employees and officers, the cost of the their defense and
fines and penalties resulting therefrom could have a material impact
on the Company's reputation, business and financial condition.
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.
15. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
In June 2006, the FASB issued Interpretation No. 48 (FIN 48) Accounting for
Uncertainty in Income Taxes, which clarifies the accounting for uncertainty in income taxes
recognized in an enterprises financial statements in accordance with FASB Statement No.
109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure, and
transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. The
Company is currently evaluating FIN 48 but does not expect it to have a material impact on
the Companys consolidated results of operations and financial condition.
19
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, eczema, 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 core
brands DYNACIN®, PLEXION®, SOLODYNTM and TRIAZ®.
Our non-acne dermatological product lines include core brands LOPROX®,
OMNICEF®, 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 core products: DYNACIN
®,LOPROX
®, OMNICEF®, PLEXION®, RESTYLANE
®,
SOLODYNTM, TRIAZ
® and VANOS. We believe that sales of our
core 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
core 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 United
States. We rely on third parties to manufacture our products.
As a result of customer buying patterns, a substantial portion of our prescription
product revenues has been recognized in the last month of each quarter, and 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. 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.
20
We sell our products primarily to major wholesalers and retail pharmacy chains.
Approximately 75% of our gross revenues are 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, 2006 and affected our results of operations, our cash flows and our financial
condition:
- |
|
Development and distribution agreement with Ipsen for rights to Ipsens
botulinum toxin product known as RELOXIN®; |
- |
|
FDA approval of our New Drug Application for SOLODYNTM; and |
- |
|
Loss contingency for a pending governmental investigation relating to our
marketing and promotion of LOPROX® products. |
Development and Distribution Agreement With Ipsen for Rights to Ipsens Botulinum Toxin
Product Known as RELOXIN®
On March 17, 2006, we 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 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. Upon execution
of the development and distribution agreement, we 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, we 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
21
certain other markets. Under the terms of the U.S., Canada and Japan agreement, we
were obligated to make an additional $35.1 million payment, as amended, to Ipsen if this
agreement was not entered into by April 15, 2006. On April 13, 2006, we entered into an
agreement with Ipsen to extend this deadline to July 15, 2006. In connection with this
extension, we 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, we reached a decision with Ipsen to not pursue an agreement for
the commercialization of the product outside of the U.S., Canada and Japan. On July 17,
2006, we 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 (including the $12.9 million amount that was paid in April 2006) was recognized
as a charge to research and development expense during the three months ended June 30, 2006.
We 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 us for the term of the agreement, which extends to September 2019.
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 agreement. Under the
terms of the agreement, we are responsible for all remaining research and development costs
associated with obtaining the products approval in the U.S., Canada and Japan. We expect
to incur significant additional research and development expenses related to the development
of RELOXIN® each quarter throughout the development process.
FDA approval of our New Drug Application for SOLODYNTM
On May 8, 2006, the FDA approved our New Drug Application for our SOLODYNTM
(minocycline HCl, USP) Extended Release Tablets. SOLODYNTM is the only oral
minocycline approved for once daily dosage in the treatment of inflammatory lesions of
non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.
SOLODYNTM is also the only approved minocycline in extended release tablet form.
The first sales of SOLODYNTM to our wholesale customers occurred during June
2006.
Loss contingency for a pending governmental investigation relating to our marketing and
promotion of LOPROX® products
The government notified us on December 14, 2004, that it is investigating claims that
we violated the federal False Claims Act. We are fully cooperating with the government in
its investigation, which relates to our marketing and promotion of LOPROX®
products to pediatricians prior to our May 2004 disposition of the Companys pediatric sales
division. In April 2006, we offered $6.0 million to resolve the governments civil claims
contingent on the execution of appropriate releases. The Justice Department countered with
a demand of $12.8 million to resolve the civil claims that the government is prepared to
pursue. In May 2006, we countered with an offer of $8.0 million that was contingent on
resolving other aspects of the governments investigation to our satisfaction. In June
2006, the Justice Department countered with a tentative demand of $10.0 million. We are
continuing to hold settlement discussions with the government in an effort to resolve their
claims, and these discussions may or may not result in a monetary settlement with the
government. Accordingly, we have accrued a loss contingency of $8.0 million as of June 30,
2006, related to this matter, of which $6.0 million was recorded during the three months
ended March 31, 2006 and $2.0 million was recorded during the three months ended June 30,
2006.
In addition, we have been notified by the United States Attorneys Office in Topeka,
Kansas that the United States Attorney is investigating whether past and present employees
and officers may have violated federal law regarding alleged off-label promotion in the
marketing and promotion of LOPROX® and LOPROX® TS to pediatricians.
No individuals have been designated as targets of the investigation. We continue to
cooperate with the government. 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.
22
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, |
|
|
|
2006 (a) |
|
|
2005 (b) |
|
|
2006 (c) |
|
|
2005 (d) |
|
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (e) |
|
|
88.9 |
|
|
|
85.8 |
|
|
|
86.5 |
|
|
|
85.6 |
|
Operating expenses |
|
|
118.3 |
|
|
|
49.4 |
|
|
|
159.1 |
|
|
|
52.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(29.4 |
) |
|
|
36.4 |
|
|
|
(72.6 |
) |
|
|
33.4 |
|
Interest income, net |
|
|
5.4 |
|
|
|
0.8 |
|
|
|
5.6 |
|
|
|
0.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss)
income before income tax |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(benefit) expense |
|
|
(24.0 |
) |
|
|
37.2 |
|
|
|
(67.0 |
) |
|
|
34.0 |
|
Income tax (benefit) expense |
|
|
(42.3 |
) |
|
|
12.9 |
|
|
|
(21.4 |
) |
|
|
11.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
18.3 |
% |
|
|
24.3 |
% |
|
|
(45.6 |
)% |
|
|
22.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
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 compensation expense related to
stock options and restricted stock and $2.0 million (2.4% of net revenues) related to a
loss contingency for a legal matter. |
|
(b) |
|
Included in operating expenses is approximately $5.3 million (5.3% of net
revenues) of business integration planning costs related to the proposed (and subsequently terminated) merger with Inamed, and $0.1
million (0.1% of net revenues) of compensation expense related to restricted stock. |
|
(c) |
|
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 compensation expense
related to stock options and restricted stock, $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. |
|
(d) |
|
Included in operating expenses is $8.3 million (4.3% of net revenues) related
to a research and development collaboration with AAIPharma, approximately $5.3 million
(2.7% of net revenues) of business integration planning costs related to the proposed
(and subsequently terminated) merger with Inamed, and $0.3 million (0.1% of net
revenues) of compensation expense related to restricted stock. |
|
(e) |
|
Gross profit does not include amortization of the related intangibles as such
expenses are included in operating expenses. |
Three Months Ended June 30, 2006 Compared to the Three Months Ended June 30, 2005
Net Revenues
The following table sets forth the net revenues for the three months ended June 30,
2006 (the second quarter of 2006) and June 30, 2005 (the second quarter of 2005), 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 |
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change% |
|
|
Change |
|
Net product revenues |
|
$ |
80.6 |
|
|
$ |
82.3 |
|
|
$ |
(1.7 |
) |
|
|
(2.0 |
)% |
Net contract revenues |
|
$ |
4.4 |
|
|
$ |
18.2 |
|
|
$ |
(13.8 |
) |
|
|
(75.9 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
85.0 |
|
|
$ |
100.5 |
|
|
$ |
(15.5 |
) |
|
|
(15.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
|
Second |
|
|
Percentage |
|
|
|
Quarter |
|
|
Quarter |
|
|
Point |
|
|
|
2006 |
|
|
2005 |
|
|
Change |
|
Acne and acne-related
dermatological products |
|
|
43.1 |
% |
|
|
27.6 |
% |
|
|
15.5 |
% |
Non-acne dermatological
products |
|
|
47.5 |
% |
|
|
49.5 |
% |
|
|
(2.0 |
)% |
Non-dermatological products |
|
|
9.4 |
% |
|
|
22.9 |
% |
|
|
(13.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues decreased during the second quarter of 2006 primarily as a
result of a decrease in net contract revenues associated with licensing agreements and
authorized generic agreements. Net contract
23
revenues decreased primarily due to a decrease
in contract revenues during the second quarter of 2006 related to our outlicensing of the
ORAPRED® brand pursuant to the terms of our license agreement with BioMarin.
Core brand revenues, which are included in net product revenues and includes revenues
associated with DYNACIN®, LOPROX®, OMNICEF®,
PLEXION®, RESTYLANE®, SOLODYN, TRIAZ® and
VANOS, represented approximately $76.3 million, or approximately 89.7% of net
revenues, during the second quarter of 2006, a decrease of approximately 0.4%, compared to
core brand revenues of approximately $76.6 million, or approximately 76.2% of net revenues,
for the second quarter of 2005. Net revenues associated with our acne and acne-related
dermatological products increased as a percentage of net revenues and increased in net
dollars by 31.9% during the second quarter of 2006 as compared to the second quarter of 2005
primarily due to initial sales of SOLODYN upon FDA approval during the second
quarter of 2006, partially offset by decreases in sales of DYNACIN®,
PLEXION® and TRIAZ® products due to competitive pressures, including
generic competition. Net revenues associated with our non-acne dermatological products
decreased as a percentage of net revenues, and decreased in net dollars by 18.8% during the
second quarter of 2006. This change included an increase in sales of RESTYLANE®,
offset by a decrease in sales of VANOS. Net revenues associated with our
non-dermatological products decreased as a percentage of net revenues, and decreased in net
dollars by 65.4% during the second quarter of 2006, primarily due to the decrease in
ORAPRED® contract revenues discussed above.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to acquired products is not included in gross profit. 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 2006 and
2005, along with the percentage of net revenues represented by such gross profit (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
75.6 |
|
|
$ |
86.3 |
|
|
$ |
(10.7 |
) |
|
|
(12.4 |
)% |
% of net revenues |
|
|
88.9 |
% |
|
|
85.8 |
% |
|
|
|
|
|
|
|
|
The decrease in gross profit during the second quarter of 2006, compared to the second
quarter of 2005, was due to the decrease in our net revenues, while 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 second quarter of 2006 as compared to the second quarter of
2005.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the
second quarter of 2006 and 2005, along with the percentage of net revenues represented by
selling, general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
51.1 |
|
|
$ |
37.5 |
|
|
$ |
13.6 |
|
|
|
36.2 |
% |
% of net revenues |
|
|
60.1 |
% |
|
|
37.3 |
% |
|
|
|
|
|
|
|
|
Inamed business integration planning
costs included in selling,
general and administrative |
|
$ |
|
|
|
$ |
5.3 |
|
|
$ |
(5.3 |
) |
|
|
(100.0 |
)% |
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
6.8 |
|
|
$ |
0.1 |
|
|
$ |
6.7 |
|
|
|
5,208.5 |
% |
24
The increase in selling, general and administrative expenses during the second quarter
of 2006 from the second quarter of 2005 was attributable to approximately $6.7 million of
additional share-based compensation expense recognized in accordance with SFAS No. 123R,
$3.0 million of increased promotion expense, primarily related to the promotion of
RESTYLANE® and the launch of SOLODYN, $2.0 million related to a loss
contingency for a legal matter related to our marketing of LOPROX® to
pediatricians (see Part II, Item 1, Legal Proceedings), and $7.2 million of other additional
selling, general and administrative expenses incurred during the second quarter of 2006,
which was partially offset by $5.3 million of business integration planning costs related to
the proposed (and subsequently terminated) merger with Inamed incurred during the second
quarter of 2005. We expect marketing and personnel expenses to increase beginning in the
third quarter of 2006 related to our preparation for the potential launch of
PERLANE®, and additional promotional costs related to RESTYLANE®.
Research and Development Expenses
The following table sets forth our research and development expenses for the second
quarter of 2006 and 2005 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Research and development |
|
$ |
43.8 |
|
|
$ |
6.1 |
|
|
$ |
37.7 |
|
|
|
619.3 |
% |
Charges included in research
and development |
|
$ |
35.1 |
|
|
$ |
|
|
|
$ |
35.1 |
|
|
|
100.0 |
% |
Share-based compensation
expense included in
research and development |
|
$ |
0.5 |
|
|
$ |
|
|
|
$ |
0.5 |
|
|
|
100.0 |
% |
Included in research and development expenses 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 compensation expense for stock
options and restricted stock. Absent these charges, research and development expenses
during the second quarter of 2006 were approximately $8.2 million. 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.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the second quarter of 2006 decreased $0.3
million, or 4.5%, to $5.8 million from $6.1 million during the second quarter of 2005. This
decrease was primarily due to a decrease in the amount of intangible assets being amortized
during the second quarter of 2006 as compared to the second quarter of 2005, due to the
write-down of a long-lived asset due to impairment during the three months ended December
31, 2005. This long-lived asset had a cost basis of approximately $15.4 million and was
being amortized at a rate of approximately $0.3 million per quarter.
Interest Income
Interest income during the second quarter of 2006 increased $3.9 million, or 113.3%, to
$7.3 million from $3.4 million during the second quarter of 2005, 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 2006.
Interest Expense
Interest expense during the second quarter of 2006 remained consistent with the second
quarter of 2005, at $2.7 million. Our interest expense during the second quarter of 2006
and 2005 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
25
and New Notes. See Note 9 in our accompanying condensed consolidated financial
statements for further discussion on the Old Notes and New Notes.
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 second quarter of 2006 and 2005
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second |
|
Second |
|
|
|
|
|
|
Quarter |
|
Quarter |
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Income tax (benefit) expense |
|
$ |
(35.9 |
) |
|
$ |
13.0 |
|
|
$ |
(48.9 |
) |
|
|
(376.6 |
)% |
Effective tax rate |
|
|
(176.0 |
)% |
|
|
34.7 |
% |
|
|
|
|
|
|
|
|
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. 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 three months ended June 30, 2006 was (176.0)% compared
to our effective tax rate of 34.7% for the three months ended June 30, 2005. 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 three months ended June 30,
2006, the Companys effective tax rate of (176.0%) differs 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®.
Our income tax benefit recorded during the second quarter of 2006 also includes a
benefit of $5.1 million relating to the resolution of certain income tax examinations for
tax years ended through June 30, 2004. Absent the tax benefit of $5.1 million booked as a
discrete item in the second quarter of 2006, we would expect our effective tax rate to be
approximately (27)% (28)% for the full calendar year.
26
Six Months Ended June 30, 2006 Compared to the Six Months Ended June 30, 2005
Net Revenues
The following table sets forth the net revenues for the six months ended June 30, 2006
(the 2006 six months) and June 30, 2005 (the 2005 six months), along with the percentage
of net revenues and percentage point change for each of our product categories (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
|
2005 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
% Change |
|
Net product revenues |
|
$ |
151.7 |
|
|
$ |
158.1 |
|
|
$ |
(6.4 |
) |
|
|
(4.0 |
)% |
Net contract revenues |
|
$ |
8.5 |
|
|
$ |
37.6 |
|
|
$ |
(29.1 |
) |
|
|
(77.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
160.2 |
|
|
$ |
195.7 |
|
|
$ |
(35.5 |
) |
|
|
(18.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
2006 Six |
|
|
2005 Six |
|
|
Point |
|
|
|
Months |
|
|
Months |
|
|
Change |
|
Acne and acne-related
dermatological products |
|
|
31.6 |
% |
|
|
26.4 |
% |
|
|
5.2 |
% |
Non-acne dermatological
products |
|
|
56.8 |
% |
|
|
49.6 |
% |
|
|
7.2 |
% |
Non-dermatological products |
|
|
11.6 |
% |
|
|
24.0 |
% |
|
|
(12.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues decreased during the 2006 six months primarily as a result of a
decrease in net contract revenues associated with licensing agreements and authorized
generic agreements. Net contract revenues decreased primarily due to a decrease in contract
revenues during the 2006 six months related to our outlicensing of the ORAPRED®
brand pursuant to the terms of our license agreement with BioMarin. Core brand revenues,
which are included in net product revenues and includes revenues associated with
DYNACIN®,
LOPROX®,
OMNICEF®,
PLEXION®,
RESTYLANE®, SOLODYN, TRIAZ® and VANOS,
represented approximately $141.1 million, or approximately 88.1% of net revenues, during the
2006 six months, a decrease of approximately 3.3%, compared to core brand revenues of
approximately $146.0 million, or approximately 74.6% of net revenues, for the 2005 six
months. Net revenues associated with our acne and acne-related dermatological products
increased as a percentage of net revenues, but decreased in net dollars by 2.1% during the
2006 six months as compared to the 2005 six months. The initial sales of
SOLODYN upon FDA approval during the second quarter of 2006 was offset by
decreases in sales of DYNACIN®, PLEXION® and TRIAZ®
products due to competitive pressures, including generic competition. Net revenues
associated with our non-acne dermatological products increased as a percentage of net
revenues, but decreased in net dollars by 6.3% during the 2006 six months. This change
included an increase in sales of RESTYLANE®, offset by decreases in sales of
VANOS and LOPROX® products. Net revenues associated with our
non-dermatological products decreased as a percentage of net revenues, and decreased in net
dollars by 60.4% during the 2006 six months, primarily due to the decrease in
ORAPRED® contract revenues discussed above.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to acquired products is not included in gross profit. 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.
27
The following table sets forth our gross profit for the 2006 six months and the 2005
six months, along with the percentage of net revenues represented by such gross profit
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
2005 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
138.6 |
|
|
$ |
167.6 |
|
|
$ |
(29.0 |
) |
|
|
(17.3 |
)% |
% of net revenues |
|
|
86.5 |
% |
|
|
85.6 |
% |
|
|
|
|
|
|
|
|
The decrease in gross profit during the 2006 six months, compared to the 2005 six
months, was due to the decrease in our net revenues, while 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 2006 six months as compared to the 2005 six months.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the
2006 six months and 2005 six months, along with the percentage of net revenues represented
by selling, general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
2005 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
102.3 |
|
|
$ |
69.4 |
|
|
$ |
32.9 |
|
|
|
47.4 |
% |
% of net revenues |
|
|
63.9 |
% |
|
|
35.5 |
% |
|
|
|
|
|
|
|
|
Inamed business integration planning
costs included in selling,
general and administrative |
|
$ |
|
|
|
$ |
5.3 |
|
|
$ |
(5.3 |
) |
|
|
(100.0 |
)% |
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
13.5 |
|
|
$ |
0.3 |
|
|
$ |
13.2 |
|
|
|
5,135.5 |
% |
The increase in selling, general and administrative expenses during the 2006 six months
from the 2005 six months was attributable to approximately $13.2 million of additional
share-based compensation expense recognized in accordance with SFAS No. 123R, $8.0 million
related to a loss contingency for a legal matter related to our marketing of
LOPROX® to pediatricians (see Part II, Item 1, Legal Proceedings), approximately
$3.0 million of increased promotional expense, primarily related to the promotion of
RESTYLANE® and the launch of SOLODYN, $1.8 million related to a
settlement of a dispute related to our merger with Ascent, and $12.2 million of additional
selling, general and administrative expenses incurred during the 2006 six months, which was
partially offset by $5.3 million of business integration planning costs related to the
proposed (and subsequently terminated) merger with Inamed incurred during the 2005 six
months.
Research and Development Expenses
The following table sets forth our research and development expenses for the 2006 six
months and 2005 six months (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
2005 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Research and development |
|
$ |
141.0 |
|
|
$ |
20.5 |
|
|
$ |
120.5 |
|
|
|
586.5 |
% |
Charges included in research
and development |
|
$ |
125.2 |
|
|
$ |
8.3 |
|
|
$ |
116.9 |
|
|
|
1,412.0 |
% |
Share-based compensation
expense included in
research and development |
|
$ |
1.0 |
|
|
$ |
|
|
|
$ |
1.0 |
|
|
|
100.0 |
% |
Included in research and development expenses 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 compensation expense for stock
options and restricted stock. Included in
28
research and development expense for the 2005 six months was approximately $8.3 million
related to a research and development collaboration with AAIPharma. Absent these charges,
research and development expenses during the 2006 six months was approximately $14.8
million, compared to approximately $12.3 million during the 2005 six months. 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 incur significant research and development expenses
related to the development of RELOXIN® each quarter throughout the development
process.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the 2006 six months decreased $0.4
million, or 3.9%, to $11.7 million from $12.1 million during the 2005 six months. This
decrease was primarily due to a decrease in the amount of intangible assets being amortized
during the 2006 six months as compared to the 2005 six months, due to the write-down of a
long-lived asset due to impairment during the three months ended December 31, 2005. This
long-lived asset had a cost basis of approximately $15.4 million and was being amortized at
a rate of approximately $0.3 million per quarter.
Interest Income
Interest income during the 2006 six months increased $7.9 million, or 123.4%, to $14.3
million from $6.4 million during the 2005 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 2006 six months.
Interest Expense
Interest expense during the 2006 six months remained consistent with the 2005 six
months, at $5.3 million. Our interest expense during the 2006 six months and 2005 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. See Note 9
in our accompanying condensed consolidated financial statements for further discussion on
the Old Notes and New Notes.
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 2006 six months and 2005 six months
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
2005 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Income tax (benefit) expense |
|
$ |
(34.3 |
) |
|
$ |
22.8 |
|
|
$ |
(57.1 |
) |
|
|
(250.7 |
)% |
Effective tax rate |
|
|
(32.0 |
)% |
|
|
34.2 |
% |
|
|
|
|
|
|
|
|
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. 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 2006 six months was (32.0)% compared to our effective
tax rate of 34.2% for the 2005 six months. Generally, the provision for income taxes
reflects managements estimate
29
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%) differs from our estimate of
the effective tax rate for the full fiscal year of (27%)-(28%) primarily due to the $5.1
million tax benefit recorded during the second quarter of 2006 relating to resolutions of
income tax examinations through years ended June 30, 2004.
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the 2006 six months
and 2005 six months, and selected balance sheet components as of June 30, 2006 and December
31, 2005 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
2005 Six |
|
|
|
|
|
|
Months |
|
Months |
|
$ Change |
|
% Change |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(100.4 |
) |
|
$ |
84.5 |
|
|
$ |
(184.9 |
) |
|
|
(218.8 |
)% |
Investing activities |
|
$ |
(126.9 |
) |
|
$ |
64.3 |
|
|
$ |
(191.2 |
) |
|
|
(297.2 |
)% |
Financing activities |
|
$ |
3.2 |
|
|
$ |
(2.3 |
) |
|
$ |
5.5 |
|
|
|
(237.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 |
|
Dec. 31, 2005 |
|
$ Change |
|
% Change |
Cash, cash equivalents and
short-term investments |
|
$ |
616.1 |
|
|
$ |
742.5 |
|
|
$ |
(126.4 |
) |
|
|
(17.0 |
)% |
Working capital |
|
$ |
608.8 |
|
|
$ |
692.5 |
|
|
$ |
(83.7 |
) |
|
|
(12.1 |
)% |
2.5% contingent convertible
senior notes due 2032 |
|
$ |
169.2 |
|
|
$ |
169.2 |
|
|
$ |
|
|
|
|
|
|
1.5% contingent convertible
senior notes due 2033 |
|
$ |
283.9 |
|
|
$ |
283.9 |
|
|
$ |
|
|
|
|
|
|
Working Capital
Working capital as of June 30, 2006 and December 31, 2005 consisted of the following
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2006 |
|
|
Dec. 31, 2005 |
|
|
$ Change |
|
|
% Change |
|
Cash, cash equivalents and
short-term investments |
|
$ |
616.1 |
|
|
$ |
742.5 |
|
|
$ |
(126.4 |
) |
|
|
(17.0 |
)% |
Accounts receivable, net |
|
|
48.3 |
|
|
|
46.7 |
|
|
|
1.6 |
|
|
|
3.5 |
% |
Inventories, net |
|
|
19.1 |
|
|
|
19.1 |
|
|
|
|
|
|
|
0.1 |
% |
Deferred tax assets, net |
|
|
15.0 |
|
|
|
12.7 |
|
|
|
2.3 |
|
|
|
17.5 |
% |
Other current assets |
|
|
14.5 |
|
|
|
12.3 |
|
|
|
2.2 |
|
|
|
17.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
713.0 |
|
|
|
833.3 |
|
|
|
(120.3 |
) |
|
|
(14.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
60.5 |
|
|
|
57.7 |
|
|
|
2.8 |
|
|
|
4.8 |
% |
Short-term contract obligation |
|
|
|
|
|
|
27.4 |
|
|
|
(27.4 |
) |
|
|
(100.0 |
)% |
Income taxes payable |
|
|
9.8 |
|
|
|
31.5 |
|
|
|
(21.7 |
) |
|
|
(68.9 |
)% |
Other current liabilities |
|
|
33.9 |
|
|
|
24.2 |
|
|
|
9.7 |
|
|
|
40.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
104.2 |
|
|
|
140.8 |
|
|
|
(36.6 |
) |
|
|
(26.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
608.8 |
|
|
$ |
692.5 |
|
|
$ |
(83.7 |
) |
|
|
(12.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $616.1 million and working
capital of $608.8 million at June 30, 2006, as compared to $742.5 million and $692.5
million, respectively, at December 31, 2005. The decreases were primarily due to payments
totaling $103.0 million made to Ipsen related to a development and distribution agreement
for the development of RELOXIN®, payment of the $27.4 million contingent payment
related to the merger with Ascent, and payments totaling $26.8 million for income taxes
during the 2006 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
30
and short-term investments are available for strategic investments, mergers and
acquisitions, 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. Occupancy of the new headquarter office space, which
is located approximately one mile from our current headquarter office space in Scottsdale,
Arizona, is expected to occur in 2008. There is no financial obligation for lease payments
until 2008.
Operating Activities
Net cash used in operating activities during the 2006 six months was approximately
$100.4 million, compared to cash provided by operating activities of approximately $84.5
million during the 2005 six months. The following is a summary of the primary components
of cash (used in) provided by operating activities during the 2006 six months and 2005 six
months (in millions):
|
|
|
|
|
|
|
|
|
|
|
2006 Six |
|
|
2005 Six |
|
|
|
Months |
|
|
Months |
|
Payments made to Ipsen related to development of RELOXIN® |
|
$ |
(103.0 |
) |
|
$ |
|
|
Payment made to AAIPharma related to a research and
development collaboration |
|
|
|
|
|
|
(8.3 |
) |
Payment of professional fees related to termination of proposed
merger with Inamed |
|
|
(16.7 |
) |
|
|
|
|
Income taxes paid |
|
|
(26.8 |
) |
|
|
(10.7 |
) |
Other cash provided by operating activities |
|
|
46.1 |
|
|
|
103.5 |
|
|
|
|
|
|
|
|
Cash (used in) provided by operating activities |
|
$ |
(100.4 |
) |
|
$ |
84.5 |
|
|
|
|
|
|
|
|
Investing Activities
Net cash used in investing activities during the 2006 six months was approximately
$126.9 million, compared to net cash provided by investing activities during the 2005 six
months of $64.3 million. The change was primarily due to the net purchases or sales of our
short-term investments during the respective six-month periods. In addition, approximately
$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 2006 six months was $3.2 million,
compared to net cash used in financing activities of $2.3 million during the 2005 six
months. Proceeds from the exercise of stock options were $5.9 million during the 2006 six
months compared to $0.9 million during the 2005 six months. Dividends paid during the 2006
six months and the 2005 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 9 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
31
covenants. The Old Notes do not contain any restrictions on the payment of dividends.
The New Notes require an adjustment to the conversion price if the cumulative aggregate of
all current and prior dividend increases above $0.025 per share would result in at least a
one percent (1%) increase in the conversion price. This threshold has not been reached and
no adjustment to the conversion price has been made.
Except for the Old Notes and the New Notes, we have no long-term liabilities and had
only $104.2 million of current liabilities at June 30, 2006. Our other commitments and
planned expenditures consist principally of payments we will make in connection with
strategic collaborations and research and development expenditures, and we will continue to
invest in sales and marketing infrastructure.
We have made available to BioMarin the ability to draw down on a Convertible Note up to
$25.0 million beginning July 1, 2005 (the Convertible Note). The Convertible Note is
convertible based on certain terms and conditions including a change of control provision.
Money advanced under the Convertible Note is convertible into BioMarin shares at a strike
price equal to the BioMarin average closing price for the 20 trading days prior to such
advance. The Convertible Note matures on the option purchase date in 2009 as defined in the
securities purchase agreement entered into on May 18, 2004 but may be repaid by BioMarin at
any time prior to the option purchase date. As of August 8, 2006, 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 $18.5 million on our common stock. In addition, on June
14, 2006, we declared a cash dividend of $0.03 per issued and outstanding share of common
stock payable on July 31, 2006 to our stockholders of record at the close of business on
July 3, 2006. 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.
Line of Credit
We have a revolving line of credit facility of up to $25.0 million from Wells Fargo
Bank, N.A. The facility may be drawn upon by us, at our discretion, and is collateralized
by certain short-term investments. Any outstanding balance of the credit facility bears
interest at a floating rate of 150 basis points in excess of the 30-day London Interbank
Offered Rate and expires in November 2006. The agreement requires us to comply with certain
covenants, including covenants relating to our financial condition and results of operation;
we are in compliance with such covenants. We have never drawn on this credit facility.
Off-Balance Sheet Arrangements
As of June 30, 2006, we are not involved in any off-balance sheet arrangements, as
defined in Item 3(a)(4)(ii) of Securities and Exchange Commission (SEC) Regulation S-K.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are
based upon our condensed consolidated financial statements, which have been prepared in
conformity with U.S. generally accepted accounting principles. The preparation of the
condensed consolidated financial statements requires us to make estimates and assumptions
that affect the amounts reported in the condensed consolidated financial statements and
accompanying notes. On an ongoing basis, we evaluate our estimates related to sales
allowances, chargebacks, rebates, returns and other pricing adjustments, depreciation and
amortization and other contingencies and litigation. We base our estimates on historical
experience and various other factors related to each circumstance. Actual results could
differ from those estimates based upon future events, which could include, among other
risks, changes in the regulations governing the manner in which we sell our products,
changes in the health care environment and managed care consumption patterns. Our
significant accounting policies are described in Note 2 to the consolidated financial
statements included in our Form 10-K/T for the six-month transition period ended December
31, 2005. We believe the following critical accounting policies
32
affect our most significant estimates and assumptions used in the preparation of our
condensed consolidated financial statements and are important in understanding our financial
condition and results of operations.
Revenue Recognition
Revenue from our product sales is recognized pursuant to Staff Accounting Bulletin No.
104 (SAB 104), Revenue Recognition in Financial Statements. Accordingly, revenue is
recognized when all four of the following criteria are met: (i) persuasive evidence that an
arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is
both fixed and determinable; and (iv) collectibility is reasonably assured. Our customers
consist primarily of large pharmaceutical wholesalers who sell directly into the retail
channel.
We do not provide any forms of price protection to our wholesale customers and permit
product returns if the product is damaged, or, depending on the customer, if it is returned
within six months prior to expiration or up to 12 months after expiration. Our customers
consist principally of financially viable wholesalers, and depending on the customer,
revenue is recognized based upon shipment (FOB shipping point) or receipt (FOB
destination), net of estimated provisions.
We enter into licensing arrangements with other parties whereby we receive contract
revenue based on the terms of the agreement. The timing of revenue recognition is dependent
on the level of our continuing involvement in the manufacture and delivery of licensed
products. If we have continuing involvement, the revenue is deferred and recognized on a
straight-line basis over the period of continuing involvement. In addition, if our
licensing arrangements require no continuing involvement and payments are merely based on
the passage of time, we assess such payments for revenue recognition under the
collectibility criteria of SAB 104.
Items Deducted From Gross Revenue
Provisions for estimates for product returns and exchanges, sales discounts,
chargebacks, managed care and Medicaid rebates and other adjustments are established as a
reduction of product sales revenues at the time such revenues are recognized. These
deductions from gross revenue are established by us as our best estimate at the time of sale
based on historical experience adjusted to reflect known changes in the factors that impact
such reserves. These deductions from gross revenue are generally reflected either as a
direct reduction to accounts receivable through an allowance, or as an addition to accrued
expenses if the payment is due to a party other than the wholesale or retail customer.
Our accounting policies for revenue recognition have a significant impact on our
reported results and rely on certain estimates that require complex and subjective judgment
on the part of our management. If the levels of product returns and exchanges, cash
discounts, chargebacks, managed care and Medicaid rebates and other adjustments fluctuate
significantly and/or if our estimates do not adequately reserve for these reductions of
gross product revenues, our reported net product revenues could be negatively affected.
Product Returns
We account for returns of product by establishing an allowance based on our estimate of
revenues recorded for which the related products are expected to be returned in the future.
We determine our estimate of product returns based on historical experience and other
qualitative factors that could impact the level of future product returns. These factors
include estimated shelf life, competitive developments including introductions of generic
products, product discontinuations and our introduction of new formulations of our products.
Typically, these other factors that influence our allowance for product returns do not
change significantly from quarter to quarter. Historical experience and the other
qualitative factors are assessed on a product-specific basis as part of our compilation of
our estimate of future product returns. Estimates for returns of new products are based on
historical experience of new products at various stages of their life cycle.
Our actual experience and the qualitative factors that we use to determine the
necessary allowance for future product returns are susceptible to change based on unforeseen
events and uncertainties. We
33
review our allowance for product returns quarterly to assess the trends being
considered to estimate the allowance, and make changes to the allowance as necessary.
Sales Discounts
We offer cash discounts to our customers as an incentive for prompt payment, generally
approximately 2% of the sales price. We account for cash discounts by establishing an
allowance reducing accounts receivable by the full amount of the discounts expected to be
taken by the customers.
Contract Chargebacks
We have agreements for contract pricing with several entities, whereby pricing on
products is extended below wholesaler list price. These parties purchase products through
wholesalers at the lower contract price, and the wholesalers charge the difference between
their acquisition cost and the lower contract price back to us. We account for chargebacks
by establishing an allowance reducing accounts receivable based on our estimate of
chargeback claims attributable to a sale. We determine our estimate of chargebacks based on
historical experience and changes to current contract prices. We also consider our claim
processing lag time, and adjust the allowance periodically throughout each quarter to
reflect actual experience.
Managed Care and Medicaid Rebates
We establish and maintain reserves for amounts payable by us to managed care
organizations and state Medicaid programs for the reimbursement of portions of the retail
price of prescriptions filled that are covered by these programs. The amounts estimated to
be paid relating to products sold are recognized as deductions from gross revenue and as
additions to accrued expenses at the time of sale based on our best estimate of the expected
prescription fill rate to these managed care and state Medicaid patients, using historical
experience adjusted to reflect known changes in the factors that impact such reserves,
including changes in formulary status and contractual pricing.
Other
In addition to the significant items deducted from gross revenue described above, we
deduct other items from gross revenue. For example, we offer consumer rebates on many of
our products and a consumer loyalty program for our RESTYLANE® dermal filler
product. We generally account for these other items deducted from gross revenue by
establishing an accrual based on our estimate of the adjustments attributable to a sale. We
generally base our estimates for the accrual of these items deducted from gross sales on
historical experience and other relevant factors. We adjust our accruals periodically
throughout each quarter based on actual experience and changes in other factors, if any.
We believe that our allowances and accruals for items that are deducted from gross
revenue are reasonable and appropriate based on current facts and circumstances. However,
it is possible that other parties applying reasonable judgment to the same facts and
circumstances could develop different allowance and accrual amounts for items that are
deducted from gross revenue. Additionally, changes in actual experience or changes in other
qualitative factors could cause our allowances and accruals to fluctuate. A five percent
change in the expenses related to the allowances and accruals described above would lead to
an approximate $5.9 million annual effect on our income before income tax expense, based on
the amount of expense we recognized during the year ended June 30, 2005 (our most recent
full fiscal year) related to the allowances and accruals described above.
Share-Based Compensation
As part of our adoption of SFAS No. 123R as of July 1, 2005, we are required to
recognize the fair value of share-based compensation awards as an expense. We apply the
Black-Scholes option-pricing model in order to determine the fair value of stock options on
the date of grant, and we apply judgment in estimating key assumptions that are important
elements in the model such as the expected stock-price volatility, expected stock option
life and expected forfeiture rates. Our estimates of these important assumptions are based
on historical data and judgment regarding market trends and factors.
34
If actual results are not consistent with our assumptions and judgments used in
estimating these factors, we may be required to record additional stock-based compensation
expense or income tax expense, which could be material to our results of operations.
Long-lived Assets
We assess the impairment of long-lived assets 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 market prices or discounted cash flow analysis.
When we determine that the useful lives of assets are shorter than we had originally
estimated, and there are sufficient cash flows to support the carrying value of the assets,
we accelerate the rate of amortization charges in order to fully amortize the assets over
their new shorter useful lives.
Income Taxes
Income taxes are determined using an annual effective tax rate, which generally differs
from the U.S. Federal statutory rate because of state and local income taxes, tax-exempt
interest, charitable contribution deductions, nondeductible expenses and research and
development tax credits available in the U.S. 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, valuation allowances
against deferred tax assets, reserves for tax audit issues and settlements, utilization of
research and development 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. We record valuation allowances against our deferred tax assets to reduce the
net carrying value to an amount that management believes is more likely than not to be
realized.
Based on the Companys historical pre-tax earnings, management believes it is more
likely than not that the Company will realize the benefit of the existing net deferred tax
assets at June 30, 2006. Management believes the existing net deductible temporary
differences will reverse during periods in which the Company generates net taxable income;
however, there can be no assurance that the Company will generate any earnings or any
specific level of continuing earnings in future years. Certain tax planning or other
strategies could be implemented, if necessary, to supplement income from operations to fully
realize recorded tax benefits.
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. We 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.
Our policy on accounting for costs of strategic collaborations determines the timing of
our recognition of certain development costs. In addition, this policy determines whether
the cost is classified as development expense or capitalized as an asset. We are 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 we acquire certain products for which there is
35
already an ANDA or NDA approval related directly to the product, and there is net
realizable value based on projected sales for these products, we capitalize the amount paid
as an intangible asset. In addition, if we acquire product rights that are in the
development phase and as to which we have no assurance that the third party will
successfully complete its developmental milestones or that the product will gain regulatory
approval, we expense such payments.
Recent Accounting Pronouncements
In June 2006, the FASB issued Interpretation No. 48 (FIN 48) Accounting for
Uncertainty in Income Taxes, which clarifies the accounting for uncertainty in income taxes
recognized in an enterprises financial statements in accordance with FASB Statement No.
109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure, and
transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. We are
currently evaluating FIN 48 but do not expect it to have a material impact on our
consolidated results of operations and financial condition.
Forward-Looking Statements
This Quarterly Report on Form 10-Q and other documents we file with the SEC include
forward-looking statements. These include statements relating to future actions,
prospective products or product approvals, future performance or results of current and
anticipated products, sales and marketing efforts, expenses, the outcome of contingencies,
such as legal proceedings, and financial results. From time to time, we also may make
forward-looking statements in press releases or written statements, or in our communications
and discussions with investors and analysts in the normal course of business through
meetings, webcasts, phone calls, and conference calls. All statements other than statements
of historical fact are, or may be deemed to be, forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended (the Exchange Act). These statements are
based on certain assumptions made by us based on our experience and perception of historical
trends, current conditions, expected future developments and other factors we believe are
appropriate in the circumstances. We caution you that actual outcomes and results may
differ materially from what is expressed, implied, or forecast by our forward-looking
statements. Such statements are subject to a number of assumptions, risks and
uncertainties, many of which are beyond our control. You can identify these statements by
the fact that they do not relate strictly to historical or current facts. They use words
such as anticipate, estimate, expect, project, intend, plan, believe, will,
should, outlook, could, target, and other words and terms of similar meaning in
connection with any discussion of future operations or financial performance. Among the
factors that could cause actual results to differ materially from our forward-looking
statements are the following:
|
|
competitive developments affecting our products, such as the recent FDA approvals of
JUVEDERM®, HYLAFORM®, HYLAFORM PLUS® and
CAPTIQUE®, competitors to RESTYLANE®, 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 our product mix; |
|
|
changes in prescription levels and the effect of economic changes in hurricane-effected areas; |
|
|
manufacturing or supply interruptions; |
|
|
importation of other dermal filler products; |
36
|
|
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; |
|
|
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 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; |
|
|
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. |
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 Transition
Report on Form 10-K/T for the six-month period ended December 31, 2005 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 factors. 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, 2006, there were no material changes to the information previously
reported under Item 7A in our Transition Report on Form 10-K/T for the six-month period
ended December 31, 2005.
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
37
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, 2006 and have concluded that, as of such date, our disclosure controls and
procedures were effective to ensure that the information we are required to disclose in
reports that we file or submit under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms.
Although the management of 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, 2006, 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
The government notified us on December 14, 2004, that it is investigating claims that
we violated the federal False Claims Act. We are fully cooperating with the government in
its investigation, which relates to our marketing and promotion of LOPROX®
products to pediatricians prior to our May 2004, disposition of the Companys pediatric
sales division. In April 2006, we offered $6.0 million to resolve the governments civil
claims contingent on the execution of appropriate releases. The Justice Department
countered with a demand of $12.8 million to resolve the civil claims that the government is
prepared to pursue. In May 2006, we countered with an offer of $8.0 million that was
contingent on resolving other aspects of the governments investigation to our satisfaction.
In June 2006, the Justice Department countered with a tentative demand of $10.0 million.
We are continuing to hold settlement discussions with the government in an effort to resolve
their claims, and these discussions may or may not result in a monetary settlement with the
government. Accordingly, we have accrued a loss contingency of $8.0 million as of June 30,
2006, related to this matter.
In addition, the Company has been notified by the United States Attorneys Office in
Topeka, Kansas that the United States Attorney is investigating whether past and present
employees and officers may have violated federal criminal law regarding alleged off-label
promotion in the marketing and promotion of LOPROX® and LOPROX® TS to
pediatricians. No individuals have been designated as targets of the investigation. The
Company continues to cooperate with the government. 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
38
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. The Court did not grant the preliminary injunction,
but the case continues and we are vigorously pursuing the matter. We have asked the U.S.
Patent and Trademark Office to confirm the validity of this patent by way of a
re-examination proceeding, which is expected to consider all of the prior art cited by the
defendants in opposition to our preliminary injunction motion.
On June 22, 2006, Medicis and Sanofi-Aventis Deutschland GmbH filed suit against
Paddock Laboratories, Inc. of Minneapolis, Minnesota for infringement of United States
Patent No. 7,018,656 B2 (the 656 patent) entitled Antimycotic Gel With High Active
Substance Release. Sanofi-Aventis Deutschland GmbH is the owner by assignment of the 656
patent. This patent contains one or more claims that cover the composition of
LOPROX® Gel (ciclopirox) 0.77%. The suit was filed in the United States District
Court for the District of Minnesota, and seeks, inter alia, a permanent injunction
prohibiting Paddock Laboratories, Inc. from engaging in any commercial manufacture, use,
offer to sell or sale within the United States or importation into the United States, of any
drug product that infringes this patent. Paddocks answer to our June 22, 2006 complaint is
due on August 14, 2006, and discovery will begin shortly thereafter.
We and certain of our subsidiaries are parties to other actions and proceedings
incident to our business, including litigation regarding our intellectual property,
challenges to the enforceability or validity of our intellectual property and claims that
our products infringe on the intellectual property rights of others. We record contingent
liabilities resulting from claims against us when it is probable (as that word is defined in
Statement of Financial Accounting Standards No. 5) that a liability has been incurred and
the amount of the loss is reasonably estimable. We disclose material contingent liabilities
when there is a reasonable possibility that the ultimate loss will exceed the recorded
liability. Estimating probable losses requires analysis of multiple factors, in some cases
including judgments about the potential actions of third-party claimants and courts.
Therefore, actual losses in any future period are inherently uncertain. In all of the cases
noted where we are the defendant, we believe we have meritorious defenses to the claims in
these actions and resolution of these matters will not have a material adverse effect on our
business, financial condition, or results of operation; however, the results of the
proceedings are uncertain, and there can be no assurance to that effect.
Item 1A. Risk Factors
There are no material changes from the risk factors previously disclosed in Part I of
Item 1A in our Transition Report on Form 10-K/T for the six month period ended December 31,
2005.
39
Item 4. Submission of Matters to a Vote of Security Holders
On May 23, 2006, the Company held its 2006 Annual Meeting of Stockholders (the Annual
Meeting). The holders of 52,299,879 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:
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:
|
|
|
|
|
|
|
|
|
|
|
Number of Votes |
|
|
For |
|
Withheld |
Arthur G. Altschul, Jr. |
|
|
42,320,912 |
|
|
|
9,978,967 |
|
Philip S. Schein, M.D. |
|
|
43,390,371 |
|
|
|
8,909,508 |
|
The directors of the Company whose terms of office continued were Mr. Jonah
Shacknai, Mr. Spencer Davidson, Mr. Stuart Diamond, Mr. Peter S. Knight, Esq., Mr.
Michael A. Pietrangelo and Ms. Lottie H. Shackelford.
2) |
|
The stockholders approved the adoption of the Medicis Pharmaceutical
Corporation 2006 Incentive Award Plan. Votes were cast as follows: |
|
|
|
|
|
|
|
For
|
|
Against
|
|
Abstain
|
|
Broker Non Vote |
|
|
|
|
|
|
|
29,900,809
|
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16,450,998
|
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113,334
|
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5,834,738 |
3) |
|
The stockholders approved the appointment of Ernst & Young LLP as independent
auditors for the fiscal year ending December 31, 2006. Votes were cast as follows: |
|
|
|
|
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For
|
|
Against
|
|
Abstain |
|
|
|
|
|
52,105,026
|
|
163,250
|
|
31,603 |
40
Item 6. Exhibits
|
|
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Exhibit 3.1
|
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Amended and Restated Bylaws of Medicis Pharmaceutical Corporation , effective
July 10, 2006 (incorporated by reference to Exhibit 3.1 to the Current Report on Form
8-K filed with the Securities and Exchange Commission on July 13, 2006) |
|
|
|
Exhibit 10.1
|
|
Medicis 2006 Incentive Award Plan (incorporated by reference to Appendix A of
the Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange
Commission on April 13, 2006) |
|
|
|
Exhibit 10.2+
|
|
Amendment to the Medicis 2006 Incentive Stock Award Plan, dated July 10, 2006 |
|
|
|
Exhibit 10.3
|
|
Employment Agreement, dated July 25, 2006, between Medicis
Pharmaceutical Corporation and Mark A. Prygocki, Sr. (incorporated by reference to
Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange
Commission on July 31, 2006) |
|
|
|
Exhibit 10.4
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical
Corporation and Mitchell S. Wortzman, Ph.D. (incorporated by reference to Exhibit 10.2
to the Current Report on Form 8-K filed with the Securities and Exchange Commission on
July 31, 2006) |
|
|
|
Exhibit 10.5
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical
Corporation and Richard J. Havens (incorporated by reference to Exhibit 10.3 to the
Current Report on Form 8-K filed with the Securities and Exchange Commission on July
31, 2006) |
|
|
|
Exhibit 10.6
|
|
Employment Agreement, dated July 27, 2006, between Medicis Pharmaceutical
Corporation and Jason D. Hanson (incorporated by reference to Exhibit 10.4 to the
Current Report on Form 8-K filed with the Securities and Exchange Commission on July
31, 2006) |
|
|
|
Exhibit 12+
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
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 |
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, 2006
|
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By:
|
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/s/ Jonah Shacknai |
|
|
|
|
|
|
|
|
|
|
|
|
|
Jonah Shacknai |
|
|
|
|
|
|
Chairman of the Board and
Chief Executive Officer |
|
|
|
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
|
|
Date: August 9, 2006
|
|
By:
|
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/s/ Mark A. Prygocki, Sr. |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark A. Prygocki, Sr. |
|
|
|
|
|
|
Executive Vice President |
|
|
|
|
|
|
Chief Financial Officer and Treasurer |
|
|
|
|
|
|
(Principal Financial and Accounting
Officer) |
|
|
42
INDEX TO EXHIBITS
|
|
|
Exhibit 3.1
|
|
Amended and Restated Bylaws of Medicis Pharmaceutical Corporation , effective
July 10, 2006 (incorporated by reference to Exhibit 3.1 to the Current Report on Form
8-K filed with the Securities and Exchange Commission on July 13, 2006) |
|
|
|
Exhibit 10.1
|
|
Medicis 2006 Incentive Award Plan (incorporated by reference to Appendix A of
the Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange
Commission on April 13, 2006) |
|
|
|
Exhibit 10.2+
|
|
Amendment to the Medicis 2006 Incentive Stock Award Plan, dated July 10, 2006 |
|
|
|
Exhibit 10.3
|
|
Employment Agreement, dated July 25, 2006, between Medicis
Pharmaceutical Corporation and Mark A. Prygocki, Sr. (incorporated by reference to
Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange
Commission on July 31, 2006) |
|
|
|
Exhibit 10.4
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical
Corporation and Mitchell S. Wortzman, Ph.D. (incorporated by reference to Exhibit 10.2
to the Current Report on Form 8-K filed with the Securities and Exchange Commission on
July 31, 2006) |
|
|
|
Exhibit 10.5
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical
Corporation and Richard J. Havens (incorporated by reference to Exhibit 10.3 to the
Current Report on Form 8-K filed with the Securities and Exchange Commission on July
31, 2006) |
|
|
|
Exhibit 10.6
|
|
Employment Agreement, dated July 27, 2006, between Medicis Pharmaceutical
Corporation and Jason D. Hanson (incorporated by reference to Exhibit 10.4 to the
Current Report on Form 8-K filed with the Securities and Exchange Commission on July
31, 2006) |
|
|
|
Exhibit 12+
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
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 |
43