e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2011
OR
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-14471
MEDICIS PHARMACEUTICAL CORPORATION
(Exact name of Registrant as specified in its charter)
|
|
|
Delaware
|
|
52-1574808 |
|
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer Identification No.) |
7720 North Dobson Road
Scottsdale, Arizona 85256-2740
(Address of principal executive offices)
(602) 808-8800
(Registrants telephone number,
including area code)
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
(Do not check if a smaller reporting company)
|
|
Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2) Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date.
|
|
|
Class
|
|
Outstanding at August 3, 2011 |
|
|
|
Class A Common Stock $.014 Par Value
|
|
63,358,951 (a)
(a) includes 2,046,565 shares of unvested restricted stock awards |
MEDICIS PHARMACEUTICAL CORPORATION
Table of Contents
Part I. Financial Information
Item 1. Financial Statements
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
150,201 |
|
|
$ |
218,362 |
|
Short-term investments |
|
|
655,555 |
|
|
|
485,192 |
|
Accounts receivable, net |
|
|
166,399 |
|
|
|
130,622 |
|
Inventories, net |
|
|
30,829 |
|
|
|
35,282 |
|
Deferred tax assets, net |
|
|
24,602 |
|
|
|
70,461 |
|
Other current assets |
|
|
19,264 |
|
|
|
15,268 |
|
Assets held for sale from discontinued operations |
|
|
10,248 |
|
|
|
13,127 |
|
|
|
|
Total current assets |
|
|
1,057,098 |
|
|
|
968,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
23,683 |
|
|
|
24,435 |
|
Net intangible assets |
|
|
197,283 |
|
|
|
195,308 |
|
Goodwill |
|
|
92,398 |
|
|
|
92,398 |
|
Deferred tax assets, net |
|
|
95,516 |
|
|
|
36,898 |
|
Long-term investments |
|
|
22,379 |
|
|
|
21,480 |
|
Other assets |
|
|
2,991 |
|
|
|
2,991 |
|
|
|
|
|
|
$ |
1,491,348 |
|
|
$ |
1,341,824 |
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
1
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
|
|
(unaudited) |
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
45,393 |
|
|
$ |
41,015 |
|
Current portion of contingent convertible senior notes |
|
|
169,145 |
|
|
|
|
|
Reserve for sales returns |
|
|
78,220 |
|
|
|
60,692 |
|
Accrued consumer rebates and loyalty programs |
|
|
124,922 |
|
|
|
101,678 |
|
Managed care and Medicaid reserves |
|
|
51,239 |
|
|
|
49,375 |
|
Income taxes payable |
|
|
|
|
|
|
4,628 |
|
Other current liabilities |
|
|
73,764 |
|
|
|
75,228 |
|
Liabilities held for sale from discontinued operations |
|
|
7,172 |
|
|
|
7,276 |
|
|
|
|
Total current liabilities |
|
|
549,855 |
|
|
|
339,892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Contingent convertible senior notes |
|
|
181 |
|
|
|
169,326 |
|
Other liabilities |
|
|
38,982 |
|
|
|
5,084 |
|
|
|
|
|
|
|
|
|
|
Stockholders Equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; shares
authorized: 5,000,000; issued and outstanding: none |
|
|
|
|
|
|
|
|
Class A common stock, $0.014 par value;
shares authorized: 150,000,000; issued and
outstanding: 74,272,334 and 71,863,191 at
June 30, 2011 and December 31, 2010,
respectively |
|
|
1,023 |
|
|
|
995 |
|
Class B common stock, $0.014 par value; shares
authorized: 1,000,000; issued and outstanding: none |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
778,120 |
|
|
|
715,651 |
|
Accumulated other comprehensive loss |
|
|
(23,298 |
) |
|
|
(2,149 |
) |
Accumulated earnings |
|
|
498,907 |
|
|
|
460,716 |
|
Less: Treasury stock, 13,059,002 and 12,897,610 shares
at cost at June 30, 2011 and December 31,
2010, respectively |
|
|
(352,422 |
) |
|
|
(347,691 |
) |
|
|
|
Total stockholders equity |
|
|
902,330 |
|
|
|
827,522 |
|
|
|
|
|
|
$ |
1,491,348 |
|
|
$ |
1,341,824 |
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
2
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Net product revenues |
|
$ |
189,819 |
|
|
$ |
171,734 |
|
|
$ |
353,715 |
|
|
$ |
335,326 |
|
Net contract revenues |
|
|
1,008 |
|
|
|
1,862 |
|
|
|
2,025 |
|
|
|
3,812 |
|
|
|
|
Net revenues |
|
|
190,827 |
|
|
|
173,596 |
|
|
|
355,740 |
|
|
|
339,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (1) |
|
|
18,237 |
|
|
|
16,330 |
|
|
|
32,568 |
|
|
|
31,437 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
172,590 |
|
|
|
157,266 |
|
|
|
323,172 |
|
|
|
307,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (2) |
|
|
90,393 |
|
|
|
77,091 |
|
|
|
175,023 |
|
|
|
149,375 |
|
Research and development (3) |
|
|
15,195 |
|
|
|
7,420 |
|
|
|
29,468 |
|
|
|
13,979 |
|
Depreciation and amortization |
|
|
7,110 |
|
|
|
6,916 |
|
|
|
14,434 |
|
|
|
13,649 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
59,892 |
|
|
|
65,839 |
|
|
|
104,247 |
|
|
|
130,698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
(1,238 |
) |
|
|
(780 |
) |
|
|
(2,512 |
) |
|
|
(1,940 |
) |
Interest expense |
|
|
1,141 |
|
|
|
1,061 |
|
|
|
2,199 |
|
|
|
2,119 |
|
Other expense, net |
|
|
|
|
|
|
(2 |
) |
|
|
|
|
|
|
257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before income tax
expense |
|
|
59,989 |
|
|
|
65,560 |
|
|
|
104,560 |
|
|
|
130,262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
25,477 |
|
|
|
24,632 |
|
|
|
43,363 |
|
|
|
49,316 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income from continuing operations |
|
|
34,512 |
|
|
|
40,928 |
|
|
|
61,197 |
|
|
|
80,946 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations, net of income
tax benefit |
|
|
5,729 |
|
|
|
4,428 |
|
|
|
13,054 |
|
|
|
9,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
28,783 |
|
|
$ |
36,500 |
|
|
$ |
48,143 |
|
|
$ |
71,868 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share continuing operations |
|
$ |
0.55 |
|
|
$ |
0.68 |
|
|
$ |
0.99 |
|
|
$ |
1.35 |
|
|
|
|
Basic net loss per share discontinued operations |
|
$ |
(0.09 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.16 |
) |
|
|
|
Basic net income per share |
|
$ |
0.46 |
|
|
$ |
0.61 |
|
|
$ |
0.78 |
|
|
$ |
1.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share continuing operations |
|
$ |
0.51 |
|
|
$ |
0.62 |
|
|
$ |
0.91 |
|
|
$ |
1.24 |
|
|
|
|
Diluted net loss per share discontinued operations |
|
$ |
(0.09 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.16 |
) |
|
|
|
Diluted net income per share |
|
$ |
0.43 |
|
|
$ |
0.56 |
|
|
$ |
0.72 |
|
|
$ |
1.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.08 |
|
|
$ |
0.06 |
|
|
$ |
0.16 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares used in calculating: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
|
60,308 |
|
|
|
58,271 |
|
|
|
59,719 |
|
|
|
58,161 |
|
|
|
|
Diluted net income per share |
|
|
67,140 |
|
|
|
64,395 |
|
|
|
66,347 |
|
|
|
64,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) amounts exclude amortization of intangible
assets related
to acquired products |
|
$ |
5,266 |
|
|
$ |
5,184 |
|
|
$ |
10,718 |
|
|
$ |
10,368 |
|
(2) amounts include share-based compensation expense |
|
$ |
8,705 |
|
|
$ |
2,070 |
|
|
$ |
14,989 |
|
|
$ |
4,957 |
|
(3) amounts include share-based compensation expense |
|
$ |
615 |
|
|
$ |
44 |
|
|
$ |
1,020 |
|
|
$ |
100 |
|
See accompanying notes to condensed consolidated financial statements.
3
MEDICIS PHARMACEUTICAL CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
Operating Activities: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
48,143 |
|
|
$ |
71,868 |
|
Loss from discontinued operations, net of income tax benefit |
|
|
13,054 |
|
|
|
9,078 |
|
|
|
|
|
|
|
|
Net income from continuing operations |
|
|
61,197 |
|
|
|
80,946 |
|
|
|
|
|
|
|
|
Adjustments to reconcile net income from continuing operations to
net cash provided by operating activities from continuing operations: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
14,434 |
|
|
|
13,649 |
|
Amortization of prior service costs, supplemental executive retirement plan |
|
|
400 |
|
|
|
|
|
Adjustment of impairment of available-for-sale investments |
|
|
|
|
|
|
260 |
|
(Gain) loss on sale of available-for-sale investments, net |
|
|
(27 |
) |
|
|
750 |
|
Share-based compensation expense |
|
|
16,009 |
|
|
|
5,057 |
|
Deferred income tax (benefit) expense |
|
|
(877 |
) |
|
|
7,099 |
|
Tax benefit (expense) from exercise of stock options and
vesting of restricted stock awards |
|
|
1,864 |
|
|
|
(269 |
) |
Excess tax benefits from share-based payment arrangements |
|
|
(2,872 |
) |
|
|
(320 |
) |
Increase in provision for sales discounts and chargebacks |
|
|
1,163 |
|
|
|
1,031 |
|
Accretion of premium on investments |
|
|
2,604 |
|
|
|
1,811 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(36,940 |
) |
|
|
(42,849 |
) |
Inventories |
|
|
4,453 |
|
|
|
(10,413 |
) |
Other current assets |
|
|
(3,995 |
) |
|
|
(3,810 |
) |
Accounts payable |
|
|
4,378 |
|
|
|
14,972 |
|
Reserve for sales returns |
|
|
17,528 |
|
|
|
1,131 |
|
Accrued consumer rebates and loyalty programs |
|
|
23,244 |
|
|
|
17,053 |
|
Managed care and Medicaid reserves |
|
|
1,863 |
|
|
|
(2,668 |
) |
Income taxes payable |
|
|
(4,628 |
) |
|
|
(13,923 |
) |
Other current liabilities |
|
|
(17,338 |
) |
|
|
(2,282 |
) |
Other liabilities |
|
|
128 |
|
|
|
(1,958 |
) |
|
|
|
|
|
|
|
Net cash provided by operating activities from continuing operations |
|
|
82,588 |
|
|
|
65,267 |
|
|
|
|
|
|
|
|
Net cash used in operating activities from discontinued operations |
|
|
(9,978 |
) |
|
|
(5,274 |
) |
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
72,610 |
|
|
|
59,993 |
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(2,834 |
) |
|
|
(3,922 |
) |
Payments for purchase of product rights |
|
|
(12,824 |
) |
|
|
768 |
|
Purchase of available-for-sale investments |
|
|
(474,810 |
) |
|
|
(273,402 |
) |
Sale of available-for-sale investments |
|
|
112,379 |
|
|
|
41,238 |
|
Maturity of available-for-sale investments |
|
|
188,865 |
|
|
|
69,515 |
|
|
|
|
|
|
|
|
Net cash used in investing activities from continuing operations |
|
|
(189,224 |
) |
|
|
(165,803 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities from discontinued operations |
|
|
|
|
|
|
(577 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(189,224 |
) |
|
|
(166,380 |
) |
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
Payment of dividends |
|
|
(8,535 |
) |
|
|
(5,993 |
) |
Excess tax benefits from share-based payment arrangements |
|
|
2,872 |
|
|
|
320 |
|
Proceeds from the exercise of stock options |
|
|
54,049 |
|
|
|
2,206 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
48,386 |
|
|
|
(3,467 |
) |
|
|
|
|
|
|
|
|
|
Effect of exchange rate on cash and cash equivalents |
|
|
67 |
|
|
|
(34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(68,161 |
) |
|
|
(109,888 |
) |
Cash and cash equivalents at beginning of period |
|
|
218,362 |
|
|
|
207,941 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
150,201 |
|
|
$ |
98,053 |
|
|
|
|
|
|
|
|
See accompanying notes to condensed consolidated financial statements.
4
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2011
(unaudited)
1. NATURE OF BUSINESS
Medicis Pharmaceutical Corporation (Medicis or the Company) is a leading specialty
pharmaceutical company focusing primarily on the development and marketing of products in the
United States (U.S.) for the treatment of dermatological and aesthetic conditions. Medicis also
markets products in Canada for the treatment of dermatological and aesthetic conditions and began
commercial efforts in Europe with the Companys acquisition of LipoSonix, Inc. (LipoSonix) in
July 2008.
The Company offers a broad range of products addressing various conditions or aesthetic
improvements including facial wrinkles, glabellar lines, acne, fungal infections,
hyperpigmentation, photoaging, psoriasis, seborrheic dermatitis and cosmesis (improvement in the
texture and appearance of skin). Medicis currently offers 13 branded products. Its primary brands
are DYSPORT®, PERLANE®, RESTYLANE®, SOLODYN®,
VANOS® and ZIANA®. Medicis entered the non-invasive body contouring market
with its acquisition of LipoSonix in July 2008. Beginning in the first quarter of 2011, the
Company classifies the LipoSonix business as a discontinued operation for financial statement
reporting purposes. See Note 2.
The consolidated financial statements include the accounts of Medicis and its wholly owned
subsidiaries. The Company does not have any subsidiaries in which it does not own 100% of the
outstanding stock. All of the Companys subsidiaries are included in the consolidated financial
statements. All significant intercompany accounts and transactions have been eliminated in
consolidation.
The accompanying interim condensed consolidated financial statements of Medicis have been
prepared in conformity with U.S. generally accepted accounting principles, consistent in all
material respects with those applied in the Companys Annual Report on Form 10-K for the year ended
December 31, 2010. The financial information is unaudited, but reflects all adjustments,
consisting only of normal recurring adjustments and accruals, which are, in the opinion of the
Companys management, necessary to a fair statement of the results for the interim periods
presented. Interim results are not necessarily indicative of results for a full year. The
information included in this Form 10-Q should be read in conjunction with the Companys Annual
Report on Form 10-K for the year ended December 31, 2010.
2. DISCONTINUED OPERATIONS
On February 25, 2011, the Company announced that as a result of the Companys strategic
planning process and the current regulatory and commercial capital equipment environment, the
Company has determined to explore strategic alternatives for its LipoSonix business including, but
not limited to, the sale of the stand-alone business. The Company has engaged an investment
banking firm to assist the Company in its exploration of strategic alternatives for LipoSonix. The
Company expects the disposal of the LipoSonix business to take place by February 2012 or before.
As a result of this decision, the Company now classifies the LipoSonix business as a discontinued
operation for financial statement reporting purposes, including comparable period results.
Intangible assets and property and equipment related to LipoSonix were determined to be
impaired as of December 31, 2010, based on the Companys analysis of the long-lived assets
carrying value and projected future cash flows. As a result of the impairment analysis, the
Company recorded a write-down of approximately $7.7 million related to LipoSonix intangible assets
and $2.1 million related to LipoSonix property and equipment during the three months ended December
31, 2010. The write-down of intangible assets and property and equipment related to LipoSonix
represented the full carrying value of the respective assets as of December 31, 2010. Therefore,
no depreciation or amortization expense was recognized during the six months ended June 30, 2011
related to the discontinued operations, as the long-lived assets of the discontinued operations
were written down to $0 as of December 31, 2010.
5
The following is a summary of loss from discontinued operations, net of income tax benefit,
for the three and six months ended June 30, 2011 and 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Net revenues |
|
$ |
200 |
|
|
$ |
448 |
|
|
$ |
356 |
|
|
$ |
1,397 |
|
Cost of revenues |
|
|
82 |
|
|
|
196 |
|
|
|
2,456 |
|
|
|
846 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
118 |
|
|
|
252 |
|
|
|
(2,100 |
) |
|
|
551 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative |
|
|
5,731 |
|
|
|
3,782 |
|
|
|
11,594 |
|
|
|
7,542 |
|
Research and development |
|
|
3,302 |
|
|
|
3,091 |
|
|
|
6,648 |
|
|
|
6,601 |
|
Depreciation and amortization |
|
|
|
|
|
|
323 |
|
|
|
|
|
|
|
643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
before income tax benefit |
|
|
(8,915 |
) |
|
|
(6,944 |
) |
|
|
(20,342 |
) |
|
|
(14,235 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
|
(3,186 |
) |
|
|
(2,516 |
) |
|
|
(7,288 |
) |
|
|
(5,157 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from discontinued operations, |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
net of income tax benefit |
|
$ |
(5,729 |
) |
|
$ |
(4,428 |
) |
|
$ |
(13,054 |
) |
|
$ |
(9,078 |
) |
|
|
|
|
|
The Company includes only revenues and costs directly attributable to the discontinued
operations, and not those attributable to the ongoing entity. Accordingly, no interest expense or
general corporate overhead costs have been allocated to the LipoSonix discontinued operations.
Included in cost of revenues for the six months ended June 30, 2011 was a $1.9 million charge
related to an increase in the valuation reserve for LipoSonix inventory that is not expected to be
sold.
The following is a summary of assets and liabilities held for sale associated with the
LipoSonix discontinued operations as of June 30, 2011 and December 31, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
878 |
|
|
$ |
629 |
|
Accounts receivable, net |
|
|
83 |
|
|
|
129 |
|
Inventories, net |
|
|
3,815 |
|
|
|
4,495 |
|
Deferred tax assets, net |
|
|
5,191 |
|
|
|
7,328 |
|
Other assets |
|
|
281 |
|
|
|
546 |
|
|
|
|
|
|
|
|
Assets held for sale from discontinued operations |
|
$ |
10,248 |
|
|
$ |
13,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,228 |
|
|
$ |
1,802 |
|
Other liabilities |
|
|
4,944 |
|
|
|
5,474 |
|
|
|
|
|
|
|
|
Liabilities held for sale from discontinued
operations |
|
$ |
7,172 |
|
|
$ |
7,276 |
|
|
|
|
|
|
|
|
6
The following is a summary of net cash used in operating activities from discontinued
operations for the six months ended June 30, 2011 and 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
Loss from discontinued operations, net of income tax benefit |
|
$ |
(13,054 |
) |
|
$ |
(9,078 |
) |
Depreciation and amortization |
|
|
|
|
|
|
643 |
|
Share-based compensation expense |
|
|
1,795 |
|
|
|
327 |
|
Decrease in assets held for sale from discontinued operations |
|
|
2,879 |
|
|
|
3,563 |
|
Decrease in liabilities held for sale from discontinued
operations |
|
|
(1,598 |
) |
|
|
(729 |
) |
|
|
|
|
|
|
|
Net cash used in operating activities from discontinued operations |
|
$ |
(9,978 |
) |
|
$ |
(5,274 |
) |
|
|
|
|
|
|
|
Net cash used in investing activities from discontinued operations of $0.6 million for the six
months ended June 30, 2010 represents purchases of property and equipment.
3. SHARE-BASED COMPENSATION
At June 30, 2011, the Company had seven active share-based employee compensation plans. Of
these seven share-based compensation plans, only the 2006 Incentive Award Plan is eligible for the
granting of future awards.
Stock Option Awards
Stock option awards are granted at the fair market value on the date of grant. The option
awards vest over a period determined at the time the options are granted, ranging from one to five
years, and generally have a maximum term of ten years. Certain options provide for accelerated
vesting if there is a change in control (as defined in the plans). When options are exercised, new
shares of the Companys Class A common stock are issued.
The total value of the stock option awards is expensed ratably over the service period of the
employees receiving the awards. As of June 30, 2011, total unrecognized compensation cost related
to stock option awards, to be recognized as expense subsequent to June 30, 2011, was approximately
$1.5 million and the related weighted average period over which it is expected to be recognized is
approximately 2.6 years. All of the unrecognized compensation cost related to stock option awards
relates to continuing operations.
A summary of stock option activity within the Companys stock-based compensation plans and
changes for the six months ended June 30, 2011, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
Balance at December 31, 2010 |
|
|
6,491,353 |
|
|
$ |
30.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
79,933 |
|
|
$ |
34.30 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,984,481 |
) |
|
$ |
27.64 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(80,705 |
) |
|
$ |
36.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2011 |
|
|
4,506,100 |
|
|
$ |
31.01 |
|
|
|
2.7 |
|
|
$ |
32,807,450 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
The intrinsic value of options exercised during the six months ended June 30, 2011 was
$16,015,062. Options exercisable under the Companys share-based compensation plans at June 30,
2011 were 4,352,288, with a weighted average exercise price of $31.18, a weighted average remaining
contractual term of 2.6 years, and an aggregate intrinsic value of $30,957,994.
A summary of outstanding and exercisable stock options that are fully vested and are expected
to vest, based on historical forfeiture rates, as of June 30, 2011, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, net of expected forfeitures |
|
|
4,238,744 |
|
|
$ |
31.19 |
|
|
|
2.7 |
|
|
$ |
30,085,482 |
|
Exercisable, net of expected forfeitures |
|
|
4,124,910 |
|
|
$ |
31.27 |
|
|
|
2.6 |
|
|
$ |
28,950,668 |
|
The fair value of each stock option award is estimated on the date of the grant using the
Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
|
|
|
|
|
|
|
|
Expected dividend yield |
|
0.77% to 0.88% |
|
1.02% to 1.06% |
|
|
|
|
|
|
|
|
Expected stock price volatility |
|
|
0.33 |
|
|
|
0.33 |
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
2.47% to 2.81% |
|
2.82% to 3.04% |
|
|
|
|
|
|
|
|
Expected life of options |
|
7.0 Years |
|
7.0 Years |
|
|
|
|
|
|
|
|
The expected dividend yield is based on expected annual dividends to be paid by the Company as
a percentage of the market value of the Companys stock as of the date of grant. The Company
determined that a blend of implied volatility and historical volatility is more reflective of
market conditions and a better indicator of expected volatility than using purely historical
volatility. The risk-free interest rate is based on the U.S. treasury security rate in effect as
of the date of grant. The expected lives of options are based on historical data of the Company.
The weighted average fair value of stock options granted during the six months ended June 30,
2011 and 2010, was $12.25 and $8.28, respectively.
Restricted Stock Awards
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. As of June 30, 2011, the total amount of unrecognized compensation cost
related to nonvested restricted stock awards, to be recognized as expense subsequent to June 30,
2011, was approximately $40.7 million, and the related weighted average period over which it is
expected to be recognized is approximately 3.4 years. Included in the $40.7 million of total
unrecognized compensation cost related to nonvested restricted stock awards is $2.6 million related
to discontinued operations.
8
A summary of restricted stock activity within the Companys share-based compensation plans and
changes for the six months ended June 30, 2011, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
Nonvested Shares |
|
Shares |
|
|
Fair Value |
|
|
Nonvested at December 31, 2010 |
|
|
1,794,445 |
|
|
$ |
17.94 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
757,310 |
|
|
$ |
31.47 |
|
Vested |
|
|
(445,912 |
) |
|
$ |
19.11 |
|
Forfeited |
|
|
(25,373 |
) |
|
$ |
23.96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2011 |
|
|
2,080,470 |
|
|
$ |
22.54 |
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the six months ended June 30, 2011 and
2010 was approximately $8.5 million and $6.6 million, respectively.
Stock Appreciation Rights
During 2009, the Company began granting cash-settled stock appreciation rights (SARs) to
many of its employees. SARs generally vest over a graduated five-year period and expire seven
years from the date of grant, unless such expiration occurs sooner due to the employees
termination of employment, as provided in the applicable SAR award agreement. SARs allow the
holder to receive cash (less applicable tax withholding) upon the holders exercise, equal to the
excess, if any, of the market price of the Companys Class A common stock on the exercise date over
the exercise price, multiplied by the number of shares relating to the SAR with respect to which
the SAR is exercised. The exercise price of the SAR is the fair market value of a share of the
Companys Class A common stock relating to the SAR on the date of grant. The total value of the
SAR is expensed over the service period of the employee receiving the grant, and a liability is
recognized in the Companys condensed consolidated balance sheets until settled. The fair value of
SARs is required to be remeasured at the end of each reporting period until the award is settled,
and changes in fair value must be recognized as compensation expense to the extent of vesting each
reporting period based on the new fair value. As of June 30, 2011, the total measured amount of
unrecognized compensation cost related to outstanding SARs, to be recognized as expense subsequent
to June 30, 2011, based on the remeasurement at June 30, 2011, was approximately $42.1 million, and
the related weighted average period over which it is expected to be recognized is approximately 3.2
years. Included in the $42.1 million of total measured unrecognized compensation cost related to
outstanding SARs is $5.3 million related to discontinued operations.
The fair value of each SAR was estimated on the date of the grant, and was remeasured at
quarter-end, using the Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SARs Granted During |
|
|
SARs Granted During |
|
|
|
|
|
|
the |
|
|
the |
|
|
Remeasurement |
|
|
|
Six Months Ended |
|
|
Six Months Ended |
|
|
as of |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
June 30, 2011 |
|
|
Expected dividend yield |
|
|
0.87 |
% |
|
0.95% to 1.06 |
% |
|
|
0.84 |
% |
Expected stock price volatility |
|
|
0.32 |
|
|
|
0.32 to 0.33 |
|
|
|
0.31 |
|
Risk-free interest rate |
|
|
3.12 |
% |
|
3.04% to 3.07 |
% |
|
1.76% to 2.50 |
% |
Expected life of SARs |
|
7.0 Years |
|
|
7.0 Years |
|
|
|
4.7 to 6.6 Years |
|
The weighted average fair value of SARs granted during the six months ended June 30, 2011
and 2010, as of the respective grant dates, was $9.90 and $8.14, respectively. The weighted
average fair value of all SARs outstanding as of the remeasurement date of June 30, 2011 was
$22.40.
9
A summary of SARs activity for the six months ended June 30, 2011 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of SARs |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
Balance at December 31, 2010 |
|
|
3,030,142 |
|
|
$ |
16.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
64,135 |
|
|
$ |
27.56 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(272,120 |
) |
|
$ |
15.48 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(166,185 |
) |
|
$ |
15.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2011 |
|
|
2,655,972 |
|
|
$ |
17.46 |
|
|
|
5.2 |
|
|
$ |
54,994,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of SARs exercised during the six months ended June 30, 2011 was
$4,937,860.
As of June 30, 2011, 88,455 SARs were exercisable, with a weighted average exercise price of
$14.69, a weighted average remaining contractual term of 4.7 years, and an aggregate intrinsic
value of $1,911,063.
Total share-based compensation expense related to continuing operations recognized during the
three months and six months ended June 30, 2011 and 2010 was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
Stock options |
|
$ |
234 |
|
|
$ |
385 |
|
|
$ |
484 |
|
|
$ |
838 |
|
Restricted stock awards |
|
|
3,197 |
|
|
|
1,291 |
|
|
|
5,799 |
|
|
|
3,176 |
|
Stock appreciation rights |
|
|
5,889 |
|
|
|
438 |
|
|
|
9,726 |
|
|
|
1,043 |
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
9,320 |
|
|
$ |
2,114 |
|
|
$ |
16,009 |
|
|
$ |
5,057 |
|
|
|
|
|
|
4. SUPPLEMENTAL EXECUTIVE RETIREMENT PLAN
On June 24, 2011, the Companys Compensation Committee adopted the Medicis Pharmaceutical
Supplemental Executive Retirement Plan (the SERP), a non-qualified, noncontributory, defined
benefit pension plan that provides supplemental retirement income for a select group of officers,
including the Companys named executive officers. The SERP is effective as of June 1, 2011.
Retirement benefits are based on a SERP participants years of service and average earnings (base
salary plus cash bonus or incentive payments) during any three calendar years of service
(regardless of whether the years are consecutive), beginning with the 2009 calendar year.
A SERP participant vests in 1/6th of his or her retirement benefit per plan year, effective as
of the first day of the plan year, and becomes fully vested in his or her accrued retirement
benefit upon (1) the participants normal retirement date, provided that the participant has at
least fifteen years of service with the Company and is employed by the Company on such date, (2)
the participants separation from service due to a discharge without cause or resignation for
good reason (as such terms are defined in the participants employment agreement, or in the
absence of such employment agreement or definitions, in the Companys Executive Retention Plan), or
(3) a change in control of the Company. A SERP participant accrues his or her retirement benefit
based on (x) the participants number of years of service with the Company (including prior years
of service), divided by (y) the number of years designated for such participants tier (which
ranges from five to twenty years).
Participants in the SERP received credit for prior service with the Company. The prior
service accrued benefit of approximately $33.8 million was recorded as other comprehensive income
within stockholders equity, and is amortized as compensation expense over the remaining service
years of each participant. Amortization of
10
prior service costs recognized as compensation expense during the three months ended June 30,
2011, was approximately $0.4 million, representing one month of amortization. The Company also
established a deferred tax asset of approximately $12.0 million, the benefit of which was also
recorded in other comprehensive income.
No investments were held by the Company related to the SERP as of June 30, 2011.
5. SHORT-TERM AND LONG-TERM INVESTMENTS
The Companys policy for its short-term and long-term investments is to establish a
high-quality portfolio that preserves principal, meets liquidity needs, avoids inappropriate
concentrations and delivers an appropriate yield in relationship to the Companys investment
guidelines and market conditions. Short-term and long-term investments consist of corporate and
various government agency and municipal debt securities. The Companys investments in auction rate
floating securities consist of investments in student loans. Management classifies the Companys
short-term and long-term investments as available-for-sale. Available-for-sale securities are
carried at fair value with unrealized gains and losses reported in stockholders equity. Realized
gains and losses and declines in value judged to be other than temporary, if any, are included in
other expense in the condensed consolidated statement of operations. A decline in the market value
of any available-for-sale security below cost that is deemed to be other than temporary, results in
impairment of the fair value of the investment. The impairment is charged to earnings and a new
cost basis for the security is established. Premiums and discounts are amortized or accreted over
the life of the related available-for-sale security. Dividends and interest income are recognized
when earned. The cost of securities sold is calculated using the specific identification method.
At June 30, 2011, the Company has recorded the estimated fair value of available-for-sale
securities in short-term and long-term investments of approximately $655.6 million and $22.4
million, respectively.
Available-for-sale securities consist of the following at June 30, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other-Than- |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Temporary |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Impairment |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate notes and bonds |
|
$ |
360,758 |
|
|
$ |
474 |
|
|
$ |
(128 |
) |
|
$ |
|
|
|
$ |
361,104 |
|
Federal agency notes and bonds |
|
|
251,136 |
|
|
|
769 |
|
|
|
(8 |
) |
|
|
|
|
|
|
251,897 |
|
Auction rate floating securities |
|
|
26,575 |
|
|
|
|
|
|
|
(6,691 |
) |
|
|
|
|
|
|
19,884 |
|
Asset-backed securities |
|
|
45,011 |
|
|
|
38 |
|
|
|
|
|
|
|
|
|
|
|
45,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
683,480 |
|
|
$ |
1,281 |
|
|
$ |
(6,827 |
) |
|
$ |
|
|
|
$ |
677,934 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three and six months ended June 30, 2011, there were no significant gross
realized gains and losses on sales of available-for-sale securities. Gross unrealized gains and
losses are determined based on the specific identification method. The net adjustment to
unrealized losses during the six months ended June 30, 2011, on available-for-sale securities
included in stockholders equity totaled $0.2 million. The amortized cost and estimated fair value
of the available-for-sale securities at June 30, 2011, by maturity, are shown below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
327,303 |
|
|
$ |
327,965 |
|
Due after one year through five years |
|
|
329,602 |
|
|
|
330,085 |
|
Due after 10 years |
|
|
26,575 |
|
|
|
19,884 |
|
|
|
|
|
|
|
|
|
|
$ |
683,480 |
|
|
$ |
677,934 |
|
|
|
|
|
|
|
|
11
Expected maturities will differ from contractual maturities because the issuers of the
securities may have the right to prepay obligations without prepayment penalties, and the Company
views its available-for-sale securities as available for current operations. At June 30, 2011,
approximately $22.4 million in estimated fair value expected to mature greater than one year has
been classified as long-term investments since these investments are in an unrealized loss
position, and management has both the ability and intent to hold these investments until recovery
of fair value, which may be maturity.
As of June 30, 2011, the Companys investments included auction rate floating securities with
a fair value of $19.9 million. The Companys auction rate floating securities are debt instruments
with a long-term maturity and with an interest rate that is reset in short intervals through
auctions. The negative conditions in the credit markets from 2008 through the first half of 2011
have prevented some investors from liquidating their holdings, including their holdings of auction
rate floating securities. During the three months ended March 31, 2008, the Company was informed
that there was insufficient demand at auction for the auction rate floating securities. As a
result, these affected auction rate floating securities are now considered illiquid, and the
Company could be required to hold them until they are redeemed by the holder at maturity. The
Company may not be able to liquidate the securities until a future auction on these investments is
successful.
During the three months ended March 31, 2010, the Company became aware of new circumstances
that directly impacted the valuation of an asset-backed security that is owned by the Company. An
unrealized loss on the asset-backed security, based on the Companys intent to hold the security
until recovery of the fair value, had previously been recorded in stockholders equity. Based on
the new circumstances related to the investment, the Company determined that the impairment of the
asset-backed security was other-than-temporary, as the Company believed it would not recover its
investment even if the asset were held to maturity. A $0.3 million impairment charge was therefore
recorded in other expense, net, during the three months ended March 31, 2010 related to the
asset-backed security. The asset-backed security was sold in April 2010.
The following table shows the gross unrealized losses and the fair value of the Companys
investments, with unrealized losses that are not deemed to be other-than-temporarily impaired
aggregated by investment category and length of time that individual securities have been in a
continuous unrealized loss position at June 30, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
|
Greater Than 12 Months |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
|
Corporate notes and bonds |
|
$ |
79,304 |
|
|
$ |
128 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and bonds |
|
|
18,892 |
|
|
|
8 |
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
|
|
|
|
|
|
|
|
19,884 |
|
|
|
6,691 |
|
Asset-backed securities |
|
|
1,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
99,986 |
|
|
$ |
136 |
|
|
$ |
19,884 |
|
|
$ |
6,691 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2011, the Company has concluded that the unrealized losses on its investment
securities are temporary in nature and are caused by changes in credit spreads and liquidity issues
in the marketplace. Available-for-sale securities are reviewed quarterly for possible
other-than-temporary impairment. This review includes an analysis of the facts and circumstances
of each individual investment such as the severity of loss, the length of time the fair value has
been below cost, the expectation for that securitys performance and the creditworthiness of the
issuer. Additionally, the Company does not intend to sell and it is not more-likely-than-not that
the Company will be required to sell any of the securities before the recovery of their amortized
cost basis.
6. FAIR VALUE MEASUREMENTS
As of June 30, 2011, the Company held certain assets that are required to be measured at fair
value on a recurring basis. These included certain of the Companys short-term and long-term
investments, including investments in auction rate floating securities.
12
The Company has invested in auction rate floating securities, which are classified as
available-for-sale securities and reflected at fair value. Due to events in credit markets, the
auction events for some of these instruments held by the Company failed during the three months
ended March 31, 2008 (see Note 5). Therefore, the fair values of these auction rate floating
securities, which are primarily rated AAA, are estimated utilizing a discounted cash flow analysis
as of June 30, 2011. These analyses consider, among other items, the collateralization underlying
the security investments, the creditworthiness of the counterparty, the timing of expected future
cash flows, and the expectation of the next time the security is expected to have a successful
auction. These investments were also compared, when possible, to other observable market data with
similar characteristics to the securities held by the Company. Changes to these assumptions in
future periods could result in additional declines in fair value of the auction rate floating
securities.
The Companys assets measured at fair value on a recurring basis subject to the disclosure
requirements of ASC 820, Fair Value Measurements and Disclosures, at June 30, 2011, were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at Reporting Date Using |
|
|
|
|
|
|
|
Quoted |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Prices in |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
|
Active |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
|
Markets |
|
|
Inputs |
|
|
Inputs |
|
|
|
June 30, 2011 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Corporate notes and bonds |
|
$ |
361,104 |
|
|
$ |
361,104 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and bonds |
|
|
251,897 |
|
|
|
251,897 |
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
19,884 |
|
|
|
|
|
|
|
|
|
|
|
19,884 |
|
Asset-backed securities |
|
|
45,049 |
|
|
|
45,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
677,934 |
|
|
$ |
658,050 |
|
|
$ |
|
|
|
$ |
19,884 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
The following tables present the Companys assets measured at fair value on a recurring
basis using significant unobservable inputs (Level 3) for the three and six months ended June 30,
2011 (in thousands):
|
|
|
|
|
|
|
Fair Value |
|
|
|
Measurements |
|
|
|
Using Significant |
|
|
|
Unobservable |
|
|
|
Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
|
Floating |
|
|
|
Securities |
|
|
Balance at March 31, 2011 |
|
$ |
20,772 |
|
Transfers to (from) Level 3 |
|
|
|
|
Total gains (losses) included in other (income) expense, net |
|
|
|
|
Total gains included in other comprehensive income |
|
|
12 |
|
Purchases |
|
|
|
|
Settlements |
|
|
(900 |
) |
|
|
|
|
Balance at June 30, 2011 |
|
$ |
19,884 |
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value |
|
|
|
Measurements |
|
|
|
Using Significant |
|
|
|
Unobservable |
|
|
|
Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
|
Floating |
|
|
|
Securities |
|
|
Balance at December 31, 2010 |
|
$ |
21,480 |
|
Transfers to (from) Level 3 |
|
|
|
|
Total gains (losses) included in other (income) expense, net |
|
|
|
|
Total gains included in other comprehensive income |
|
|
404 |
|
Purchases |
|
|
|
|
Settlements |
|
|
(2,000 |
) |
|
|
|
|
Balance at June 30, 2011 |
|
$ |
19,884 |
|
|
|
|
|
7. RESEARCH AND DEVELOPMENT
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
14
Abbreviated New Drug Application (ANDA) or a New Drug Application (NDA) approval related
directly to the product, and there is net realizable value based on projected sales for these
products, the Company capitalizes the amount paid as an intangible asset. If the Company acquires
product rights which are in the development phase and to which the Company has no assurance that
the third party will successfully complete its development milestones, the Company expenses such
payments.
Research and development expense for the three and six months ended June 30, 2011 and 2010 are
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Ongoing research and development costs |
|
$ |
7,080 |
|
|
$ |
7,376 |
|
|
$ |
13,948 |
|
|
$ |
13,879 |
|
Payments related to strategic collaborations |
|
|
7,500 |
|
|
|
|
|
|
|
14,500 |
|
|
|
|
|
Share-based compensation expense |
|
|
615 |
|
|
|
44 |
|
|
|
1,020 |
|
|
|
100 |
|
|
|
|
Total research and development |
|
$ |
15,195 |
|
|
$ |
7,420 |
|
|
$ |
29,468 |
|
|
$ |
13,979 |
|
|
|
|
8. STRATEGIC COLLABORATIONS
Collaboration with a privately-held U.S. biotechnology company
On September 10, 2010, the Company and a privately-held U.S. biotechnology company entered
into a sublicense and development agreement to develop an agent for specific dermatological
conditions in the Americas and Europe and a purchase option to acquire the privately-held U.S.
biotechnology company.
Under the terms of the agreements, the Company paid the privately-held U.S. biotechnology
company $5.0 million in connection with the execution of the agreement, and will pay additional
potential milestone payments totaling approximately $100.5 million upon successful completion of
certain clinical, regulatory and commercial milestones.
During the three months ended December 31, 2010 and June 30, 2011, development milestones were
achieved, and the Company made a $10.0 million and a $5.5 million payment, respectively, pursuant
to the agreements. The initial $5.0 million payment, the $10.0 million milestone payment and the
$5.5 million milestone payment were recognized as research and development expense during the three
months ended September 30, 2010, December 31, 2010 and June 30, 2011, respectively.
Anacor
On February 9, 2011, the Company entered into a research and development agreement with Anacor
Pharmaceuticals, Inc. (Anacor) for the discovery and development of boron-based small molecule
compounds directed against a target for the potential treatment of acne. Under the terms of the
agreement, the Company paid Anacor $7.0 million in connection with the execution of the agreement,
and will pay up to $153.0 million upon the achievement of certain research, development, regulatory
and commercial milestones, as well as royalties on sales by the Company. Anacor will be
responsible for discovering and conducting the early development of product candidates which
utilize Anacors proprietary boron chemistry platform, while the Company will have an option to
obtain an exclusive license for products covered by the agreement. The initial $7.0 million
payment was recognized as research and development expense during the three months ended March 31,
2011.
9. SEGMENT AND PRODUCT INFORMATION
The Company operates in one 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 SOLODYN® and ZIANA®.
During early 2011, the Company discontinued its TRIAZ® branded products and decided to
no longer promote its PLEXION® branded products. The non-acne dermatological product
lines include DYSPORT®, LOPROX®,
15
PERLANE®, RESTYLANE® and VANOS®. The non-dermatological product
lines include AMMONUL® and BUPHENYL®. The non-dermatological field also
includes contract revenues associated with licensing agreements and authorized generics.
The Companys pharmaceutical products, with the exception of AMMONUL® and
BUPHENYL®, are promoted to dermatologists and plastic surgeons. Such products are often
prescribed by physicians outside these two specialties, including family practitioners, general
practitioners, primary-care physicians and OB/GYNs, as well as hospitals, government agencies, and
others. Currently, the Companys products are sold primarily to wholesalers and retail chain drug
stores.
Net revenues and the percentage of net revenues for each of the product categories are as
follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne and acne-related dermatological products |
|
$ |
123,130 |
|
|
$ |
124,763 |
|
|
$ |
226,592 |
|
|
$ |
244,976 |
|
Non-acne dermatological products |
|
|
57,719 |
|
|
|
41,017 |
|
|
|
109,940 |
|
|
|
75,269 |
|
Non-dermatological products |
|
|
9,978 |
|
|
|
7,816 |
|
|
|
19,208 |
|
|
|
18,893 |
|
|
|
|
Total net revenues |
|
$ |
190,827 |
|
|
$ |
173,596 |
|
|
$ |
355,740 |
|
|
$ |
339,138 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
Acne and acne-related dermatological products |
|
|
65 |
% |
|
|
72 |
% |
|
|
64 |
% |
|
|
72 |
% |
Non-acne dermatological products |
|
|
30 |
|
|
|
24 |
|
|
|
31 |
|
|
|
22 |
|
Non-dermatological products |
|
|
5 |
|
|
|
4 |
|
|
|
5 |
|
|
|
6 |
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
10. INVENTORIES
The Company primarily utilizes third parties to manufacture and package inventories held for
sale, takes title to certain inventories once manufactured, and warehouses such goods until
packaged for final distribution and sale. Inventories consist of salable products held at the
Companys warehouses, as well as raw materials and components at the manufacturers facilities, and
are valued at the lower of cost or market using the first-in, first-out method. The Company
provides valuation reserves for estimated obsolescence or unmarketable inventory in an amount equal
to the difference between the cost of inventory and the estimated market value based upon
assumptions about future demand and market conditions.
Inventory costs associated with products that have not yet received regulatory approval are
capitalized if, in the view of the Companys management, there is probable future commercial use
and future economic benefit. If future commercial use and future economic benefit are not
considered probable, then costs associated with pre-launch inventory that has not yet received
regulatory approval are expensed as research and development expense during the period the costs
are incurred. As of June 30, 2011 and December 31, 2010, there were no costs capitalized into
inventory for products that had not yet received regulatory approval.
16
Inventories are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
Raw materials |
|
$ |
12,103 |
|
|
$ |
15,801 |
|
Work-in-process |
|
|
3,370 |
|
|
|
3,236 |
|
Finished goods |
|
|
19,930 |
|
|
|
24,838 |
|
Valuation reserve |
|
|
(4,574 |
) |
|
|
(8,593 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
30,829 |
|
|
$ |
35,282 |
|
|
|
|
|
|
|
|
11. OTHER CURRENT LIABILITIES
Other current liabilities are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
Accrued incentives, including SARs liability |
|
$ |
33,346 |
|
|
$ |
33,923 |
|
Deferred revenue |
|
|
13,799 |
|
|
|
16,422 |
|
Other accrued expenses |
|
|
26,619 |
|
|
|
24,883 |
|
|
|
|
|
|
|
|
|
|
$ |
73,764 |
|
|
$ |
75,228 |
|
|
|
|
|
|
|
|
Deferred revenue is comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
December 31, 2010 |
|
Deferred revenue aesthetics products, net
of cost of revenue |
|
$ |
9,802 |
|
|
$ |
10,334 |
|
Deferred contract revenue |
|
|
1,467 |
|
|
|
3,014 |
|
Deferred revenue sales into distribution
channel in excess of eight weeks of
projected demand |
|
|
2,441 |
|
|
|
582 |
|
Other deferred revenue |
|
|
89 |
|
|
|
2,492 |
|
|
|
|
|
|
|
|
|
|
$ |
13,799 |
|
|
$ |
16,422 |
|
|
|
|
|
|
|
|
The Company defers revenue, and the related cost of revenue, of its aesthetics products,
including DYSPORT®, PERLANE® and RESTYLANE®, until its exclusive
U.S. distributor ships the product to physicians. Deferred contract revenue primarily relates to
the Companys strategic collaboration with Hyperion Therapeutics, Inc. The Company also defers the
recognition of revenue for certain sales of inventory into the distribution channel that are in
excess of eight (8) weeks of projected demand.
12. CONTINGENT CONVERTIBLE SENIOR NOTES
In June 2002, the Company sold $400.0 million aggregate principal amount of its 2.5%
Contingent Convertible Senior Notes Due 2032 (the Old Notes) in private transactions. As
discussed below, approximately $230.8 million in principal amount of the Old Notes was exchanged
for New Notes on August 14, 2003. The Old Notes bear interest at a rate of 2.5% per annum, which
is payable on June 4 and December 4 of each year, beginning on December 4, 2002. The Company also
agreed to pay contingent interest at a rate equal to 0.5% per annum during any six-month period,
with the initial six-month period commencing June 4, 2007, if the average trading price of the Old
Notes reaches certain thresholds. Contingent interest of $0.1 million was payable at June 30,
2011. No contingent interest related to the Old Notes was payable at December 31, 2010. 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
17
interest, including contingent interest, if any. Holders of the Old Notes may require the Company
to repurchase all or a portion of their Old Notes on June 4, 2012 and June 4, 2017, or upon a
change in control, as defined in the indenture governing the Old Notes, at 100% of the principal
amount of the Old Notes, plus accrued and unpaid interest to the date of the repurchase, payable in
cash. Under GAAP, if an obligation is due on demand or will be due on demand within one year from
the balance sheet date, even though liquidation may not be expected within that period, it should
be classified as a current liability. Accordingly, the outstanding balance of Old Notes along with
the deferred tax liability associated with accelerated interest deductions on the Old Notes will be
classified as a current liability during the respective twelve month periods prior to June 4, 2012
and June 4, 2017. As of June 30, 2011, $169.1 million of the Old Notes and $57.9 million of
deferred tax liabilities were classified as current liabilities in the Companys condensed
consolidated balance sheets. The $57.9 million of deferred tax liabilities were included within
current deferred tax assets, net. If all of the Old Notes are put back to the Company on June 4,
2012, the Company would be required to pay $169.1 million in outstanding principal, plus accrued
interest. The Company would also be required to pay the accumulated deferred tax liability related
to the Old Notes.
The Old Notes are convertible, at the holders option, prior to the maturity date into shares
of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after June 30, 2002, if the closing price of the Companys
Class A common stock over a specified number of trading days during the previous quarter,
including the last trading day of such quarter, is more than 110% of the conversion price
of the Old Notes, or $31.96. The Old Notes are initially convertible at a conversion price
of $29.05 per share, which is equal to a conversion rate of approximately 34.4234 shares
per $1,000 principal amount of Old Notes, subject to adjustment; |
|
|
|
if the Company has called the Old Notes for redemption; |
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the Old Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
Old Notes; or |
|
|
|
upon the occurrence of specified corporate transactions. |
The Old Notes, which are unsecured, do not contain any restrictions on the payment of
dividends, the incurrence of additional indebtedness or the repurchase of the Companys securities
and do not contain any financial covenants.
The Company incurred $12.6 million of fees and other origination costs related to the issuance
of the Old Notes. The Company amortized these costs over the first five-year Put period, which ran
through June 4, 2007.
On August 14, 2003, the Company exchanged approximately $230.8 million in principal amount of
its Old Notes for approximately $283.9 million in principal amount of its 1.5% Contingent
Convertible Senior Notes Due 2033 (the New Notes). Holders of Old Notes that accepted the
Companys exchange offer received $1,230 in principal amount of New Notes for each $1,000 in
principal amount of Old Notes. The terms of the New Notes are similar to the terms of the Old
Notes, but have a different interest rate, conversion rate and maturity date. Holders of Old Notes
that chose not to exchange continue to be subject to the terms of the Old Notes.
The New Notes bear interest at a rate of 1.5% per annum, which is payable on June 4 and
December 4 of each year, beginning December 4, 2003. The Company will also pay contingent interest
at a rate of 0.5% per annum during any six-month period, with the initial six-month period
commencing June 4, 2008, if the average trading price of the New Notes reaches certain thresholds.
No contingent interest related to the New Notes was payable at June 30, 2011 or December 31, 2010.
The New Notes mature on June 4, 2033.
As a result of the exchange, the outstanding principal amounts of the Old Notes and the New
Notes were $169.2 million and $283.9 million, respectively. The Company incurred approximately
$5.1 million of fees and other origination costs related to the issuance of the New Notes. The
Company amortized these costs over the first five-year Put period, which ran through June 4, 2008.
18
Holders of the New Notes were able to require the Company to repurchase all or a portion of
their New Notes on June 4, 2008, at 100% of the principal amount of the New Notes, plus accrued and
unpaid interest, including contingent interest, if any, to the date of the repurchase, payable in
cash. Holders of approximately $283.7 million of New Notes elected to require the Company to
repurchase their New Notes on June 4, 2008. The Company paid $283.7 million, plus accrued and
unpaid interest of approximately $2.2 million, to the holders of New Notes that elected to require
the Company to repurchase their New Notes. The Company was also required to pay an accumulated
deferred tax liability of approximately $34.9 million related to the repurchased New Notes. This
$34.9 million deferred tax liability was paid during the second half of 2008. Following the
repurchase of these New Notes, $181,000 of principal amount of New Notes remained outstanding as of
June 30, 2011 and December 31, 2010.
The remaining New Notes are convertible, at the holders option, prior to the maturity date
into shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after September 30, 2003, if the closing price of the
Companys Class A common stock over a specified number of trading days during the previous
quarter, including the last trading day of such quarter, is more than 120% of the
conversion price of the New Notes, or $46.51. The Notes are initially convertible at a
conversion price of $38.76 per share, which is equal to a conversion rate of approximately
25.7998 shares per $1,000 principal amount of New Notes, subject to adjustment; |
|
|
|
if the Company has called the New Notes for redemption; |
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the New Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
New Notes; or |
|
|
|
upon the occurrence of specified corporate transactions. |
The remaining New Notes, which are unsecured, do not contain any restrictions on the
incurrence of additional indebtedness or the repurchase of the Companys securities and do not
contain any financial covenants. The New Notes require an adjustment to the conversion price if
the cumulative aggregate of all current and prior dividend increases above $0.025 per share would
result in at least a one percent (1%) increase in the conversion price. This threshold has not
been reached and no adjustment to the conversion price has been made.
During the quarter ended June 30, 2011, 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 quarter ended June 30, 2011. The holders of Old Notes have
this conversion right only until September 30, 2011. At the end of each future quarter, the
conversion rights will be reassessed in accordance with the bond indenture agreement to determine
if the conversion trigger rights have been achieved. During the quarter ended June 30, 2011, the
New Notes did not meet the criteria for the right of conversion.
13. INCOME TAXES
Income taxes are determined using an annual effective tax rate, which generally differs from
the U.S. Federal statutory rate, primarily because of state and local income taxes, enhanced
charitable contribution deductions for inventory, tax credits available in the U.S., the treatment
of certain share-based payments that are not designed to normally result in tax deductions, various
expenses that are not deductible for tax purposes, changes in valuation allowances against deferred
tax assets and differences in tax rates in certain non-U.S. jurisdictions. The Companys effective
tax rate may be subject to fluctuations during the year as new information is obtained which may
affect the assumptions it uses to estimate its annual effective tax rate, including factors such as
its mix of pre-tax earnings in the various tax jurisdictions in which it operates, changes in
valuation allowances against deferred tax assets, reserves for tax audit issues and settlements,
utilization of tax credits and changes in tax laws in jurisdictions where the Company conducts
operations. The Company recognizes tax benefits only if the tax position is more likely than not
of being sustained. The Company recognizes deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax basis of its assets and
liabilities, along with net
19
operating losses and credit carryforwards. The Company records
valuation allowances against its deferred tax assets to reduce the net carrying value to amounts
that management believes is more likely than not to be realized.
At June 30, 2011, the Company has an unrealized tax loss of $21.0 million related to the
Companys option to acquire Revance or license Revances topical product that is under development.
The Company will not be able to determine the character of the loss until the Company exercises or
fails to exercise its option. A realized loss characterized as a capital loss can only be utilized
to offset capital gains. At June 30, 2011, the Company has recorded a valuation allowance of $7.6
million against the deferred tax asset associated with this unrealized tax loss in order to reduce
the carrying value of the deferred tax asset to $0, which is the amount that management believes is
more likely than not to be realized.
At June 30, 2011, the Company has an unrealized tax loss of $21.9 million related to the
Companys option to acquire a privately-held U.S. biotechnology company. If the Company fails to
exercise its option, a capital loss will be recognized. A loss characterized as a capital loss can
only be used to offset capital gains. At June 30, 2011, the Company has recorded a valuation
allowance of $7.9 million against the deferred tax asset associated with this unrealized tax loss
in order to reduce the carrying value of the deferred tax asset to $0, which is the amount that
management believes is more likely than not to be realized.
During the three months ended June 30, 2011 and June 30, 2010, the Company made net tax
payments of $32.0 million and $30.9 million, respectively. During the six months ended June 30,
2011 and June 30, 2010, the Company made net tax payments of $38.0 million and $47.7 million,
respectively.
The Company operates in multiple tax jurisdictions and is periodically subject to audit in
these jurisdictions. These audits can involve complex issues that may require an extended period
of time to resolve and may cover multiple years. The Company and its domestic subsidiaries file a
consolidated U.S. federal income tax return. Such returns have either been audited or settled
through statute expiration through 2006. The state of California conducted an examination on the
Companys tax returns for the periods ending June 30, 2005, December 31, 2005, December 31, 2006
and December 31, 2007. During the three months ended March 31, 2011, the Company reached a
settlement for all periods with the state of California and paid approximately $0.5 million. The
state of California has also notified the Company of an upcoming examination of the Companys tax
returns for the periods ending December 31, 2008 and December 31, 2009.
The Company owns two subsidiaries that file corporate tax returns in Sweden. The Swedish tax
authorities examined the tax return of one of the subsidiaries for fiscal 2004. The examiners
issued a no change letter, and the examination is complete. The Companys other subsidiary in
Sweden has not been examined by the Swedish tax authorities. The Swedish statute of limitations
may be open for up to five years from the date the tax return was filed. Thus, all returns filed
for periods ending December 31, 2006 forward are open under the statute of limitations.
At June 30, 2011 and December 31, 2010, the Company had unrecognized tax benefits of $1.0
million and $1.4 million, respectively. The amount of unrecognized tax benefits which, if
ultimately recognized, could favorably affect the Companys effective tax rate in a future period
is $0.6 million and $0.9 million as of June 30, 2011 and December 31, 2010, respectively. During
the next twelve months, the Company estimates that it is reasonably possible that the amount of
unrecognized tax benefits will decrease by $0.7 million.
The Company recognizes accrued interest and penalties, if applicable, related to unrecognized
tax benefits in income tax expense. The Company had approximately $0.5 million for the payment of
interest and penalties accrued (net of tax benefit) at June 30, 2011 and December 31, 2010.
14. DIVIDENDS DECLARED ON COMMON STOCK
On June 8, 2011, the Company announced that its Board of Directors had declared a cash
dividend of $0.08 per issued and outstanding share of the Companys Class A common stock, which was
paid on July 29, 2011, to stockholders of record at the close of business on July 1, 2011. The
$5.1 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, 2011.
The Company has not adopted a dividend policy.
20
15. COMPREHENSIVE INCOME
Total comprehensive income includes net income and other comprehensive income (loss), which
consists of foreign currency translation adjustments, unrealized gains and losses on
available-for-sale investments and unamortized prior service costs related to the Companys
supplemental executive retirement plan. Total comprehensive income for the three months ended June
30, 2011 and 2010, was $7.4 million and $36.9 million, respectively. Total comprehensive income
for the six months ended June 30, 2011 and 2010, was $27.0 million and $72.9 million, respectively.
Included as a reduction of total comprehensive income for the three and six months ended June 30,
2011 is $21.4 million related to the establishment of prior service costs related to the Companys
supplemental executive retirement plan, net of income tax benefit.
21
16. NET INCOME PER COMMON SHARE
The following table sets forth the computation of basic and diluted net income per common
share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
|
Continuing |
|
|
Discontinued |
|
|
Net |
|
|
Continuing |
|
|
Discontinued |
|
|
Net |
|
|
|
Operations |
|
|
Operations |
|
|
Income |
|
|
Operations |
|
|
Operations |
|
|
Income |
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
34,512 |
|
|
$ |
(5,729 |
) |
|
$ |
28,783 |
|
|
$ |
40,928 |
|
|
$ |
(4,428 |
) |
|
$ |
36,500 |
|
Less: income (loss) allocated to
participating securities |
|
|
1,113 |
|
|
|
|
|
|
|
916 |
|
|
|
1,355 |
|
|
|
|
|
|
|
1,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) available to
common stockholders |
|
|
33,399 |
|
|
|
(5,729 |
) |
|
|
27,867 |
|
|
|
39,573 |
|
|
|
(4,428 |
) |
|
|
35,294 |
|
Weighted average number of common
shares outstanding |
|
|
60,308 |
|
|
|
60,308 |
|
|
|
60,308 |
|
|
|
58,271 |
|
|
|
58,271 |
|
|
|
58,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per
common share |
|
$ |
0.55 |
|
|
$ |
(0.09 |
) |
|
$ |
0.46 |
|
|
$ |
0.68 |
|
|
$ |
(0.08 |
) |
|
$ |
0.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
34,512 |
|
|
$ |
(5,729 |
) |
|
$ |
28,783 |
|
|
$ |
40,928 |
|
|
$ |
(4,428 |
) |
|
$ |
36,500 |
|
Less: income (loss) allocated to
participating securities |
|
|
1,113 |
|
|
|
|
|
|
|
916 |
|
|
|
1,355 |
|
|
|
|
|
|
|
1,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) available to
common stockholders |
|
|
33,399 |
|
|
|
(5,729 |
) |
|
|
27,867 |
|
|
|
39,573 |
|
|
|
(4,428 |
) |
|
|
35,294 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings allocated to
unvested stockholders |
|
|
(987 |
) |
|
|
|
|
|
|
(796 |
) |
|
|
(1,263 |
) |
|
|
|
|
|
|
(1,113 |
) |
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings
re-allocated to
unvested stockholders |
|
|
971 |
|
|
|
|
|
|
|
783 |
|
|
|
1,256 |
|
|
|
|
|
|
|
1,107 |
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense
related to Old Notes |
|
|
711 |
|
|
|
|
|
|
|
711 |
|
|
|
666 |
|
|
|
|
|
|
|
666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) assuming dilution |
|
$ |
34,094 |
|
|
$ |
(5,729 |
) |
|
$ |
28,565 |
|
|
$ |
40,232 |
|
|
$ |
(4,428 |
) |
|
$ |
35,954 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding |
|
|
60,308 |
|
|
|
60,308 |
|
|
|
60,308 |
|
|
|
58,271 |
|
|
|
58,271 |
|
|
|
58,271 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
|
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
|
|
|
|
5,823 |
|
New Notes |
|
|
4 |
|
|
|
|
|
|
|
4 |
|
|
|
4 |
|
|
|
|
|
|
|
4 |
|
Stock options |
|
|
1,005 |
|
|
|
|
|
|
|
1,005 |
|
|
|
297 |
|
|
|
|
|
|
|
297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares assuming dilution |
|
|
67,140 |
|
|
|
60,308 |
|
|
|
67,140 |
|
|
|
64,395 |
|
|
|
58,271 |
|
|
|
64,395 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per
common share |
|
$ |
0.51 |
|
|
$ |
(0.09 |
) |
|
$ |
0.43 |
|
|
$ |
0.62 |
|
|
$ |
(0.08 |
) |
|
$ |
0.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, 2011 |
|
|
June 30, 2010 |
|
|
|
Continuing |
|
|
Discontinued |
|
|
Net |
|
|
Continuing |
|
|
Discontinued |
|
|
Net |
|
|
|
Operations |
|
|
Operations |
|
|
Income |
|
|
Operations |
|
|
Operations |
|
|
Income |
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
61,197 |
|
|
$ |
(13,054 |
) |
|
$ |
48,143 |
|
|
$ |
80,946 |
|
|
$ |
(9,078 |
) |
|
$ |
71,868 |
|
Less: income (loss) allocated to
participating securities |
|
|
1,905 |
|
|
|
|
|
|
|
1,469 |
|
|
|
2,673 |
|
|
|
|
|
|
|
2,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) available to
common stockholders |
|
|
59,292 |
|
|
|
(13,054 |
) |
|
|
46,674 |
|
|
|
78,273 |
|
|
|
(9,078 |
) |
|
|
69,500 |
|
Weighted average number of common
shares outstanding |
|
|
59,719 |
|
|
|
59,719 |
|
|
|
59,719 |
|
|
|
58,161 |
|
|
|
58,161 |
|
|
|
58,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per
common share |
|
$ |
0.99 |
|
|
$ |
(0.22 |
) |
|
$ |
0.78 |
|
|
$ |
1.35 |
|
|
$ |
(0.16 |
) |
|
$ |
1.19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
61,197 |
|
|
$ |
(13,054 |
) |
|
$ |
48,143 |
|
|
$ |
80,946 |
|
|
$ |
(9,078 |
) |
|
$ |
71,868 |
|
Less: income (loss) allocated to
participating securities |
|
|
1,905 |
|
|
|
|
|
|
|
1,469 |
|
|
|
2,673 |
|
|
|
|
|
|
|
2,368 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) available to
common stockholders |
|
|
59,292 |
|
|
|
(13,054 |
) |
|
|
46,674 |
|
|
|
78,273 |
|
|
|
(9,078 |
) |
|
|
69,500 |
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings allocated to
unvested stockholders |
|
|
(1,668 |
) |
|
|
|
|
|
|
(1,245 |
) |
|
|
(2,474 |
) |
|
|
|
|
|
|
(2,170 |
) |
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings
re-allocated to
unvested stockholders |
|
|
1,647 |
|
|
|
|
|
|
|
1,229 |
|
|
|
2,461 |
|
|
|
|
|
|
|
2,159 |
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense
related to Old Notes |
|
|
1,376 |
|
|
|
|
|
|
|
1,376 |
|
|
|
1,332 |
|
|
|
|
|
|
|
1,332 |
|
Tax-effected interest expense
related to New Notes |
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
1 |
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) assuming dilution |
|
$ |
60,648 |
|
|
$ |
(13,054 |
) |
|
$ |
48,035 |
|
|
$ |
79,593 |
|
|
$ |
(9,078 |
) |
|
$ |
70,822 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding |
|
|
59,719 |
|
|
|
59,719 |
|
|
|
59,719 |
|
|
|
58,161 |
|
|
|
58,161 |
|
|
|
58,161 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
|
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
|
|
|
|
5,823 |
|
New Notes |
|
|
4 |
|
|
|
|
|
|
|
4 |
|
|
|
4 |
|
|
|
|
|
|
|
4 |
|
Stock options |
|
|
801 |
|
|
|
|
|
|
|
801 |
|
|
|
306 |
|
|
|
|
|
|
|
306 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares assuming dilution |
|
|
66,347 |
|
|
|
59,719 |
|
|
|
66,347 |
|
|
|
64,294 |
|
|
|
58,161 |
|
|
|
64,294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per
common share |
|
$ |
0.91 |
|
|
$ |
(0.22 |
) |
|
$ |
0.72 |
|
|
$ |
1.24 |
|
|
$ |
(0.16 |
) |
|
$ |
1.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share must be calculated using the if-converted method.
Diluted net income per share using the if-converted method is calculated by adjusting net income
for tax-effected net interest on the Old Notes and New Notes, divided by the weighted average
number of common shares outstanding assuming conversion.
23
Unvested share-based payment awards that contain rights to receive nonforfeitable dividends or
dividend equivalents (whether paid or unpaid) are participating securities, and thus, are included
in the two-class method of computing earnings per share. The two-class method is an earnings
allocation formula that treats a participating security as having rights to earnings that would
otherwise have been available to common stockholders. Restricted stock granted to certain
employees by the Company (see Note 3) participate in dividends on the same basis as common shares,
and these dividends are not forfeitable by the holders of the restricted stock. As a result, the
restricted stock grants meet the definition of a participating security.
The diluted net income per common share computation for the three months ended June 30, 2011
and 2010 excludes 1,797,876 and 8,027,204 shares of stock, respectively, that represented
outstanding stock options whose impact would be anti-dilutive. The diluted net income per common
share computation for the six months ended June 30, 2011 and 2010 excludes 3,291,806 and 8,559,315
shares of stock, respectively, that represented outstanding stock options whose impact would be
anti-dilutive.
Due to the net loss from discontinued operations during the three and six months ended June
30, 2011 and 2010, diluted earnings per share and basic earnings per share from discontinued
operations are the same, as the effect of potentially dilutive securities would be anti-dilutive.
17. COMMITMENTS AND CONTINGENCIES
Legal Matters
The Company is currently party to various legal proceedings, including those noted in this
section. Unless specifically noted below, any possible range of loss associated with the legal
proceedings described below is not reasonably estimable at this time. The Company is engaged in
numerous other legal actions not described below arising in the ordinary course of its business
and, while there can be no assurance, the Company believes that the ultimate outcome of these
actions will not have a material adverse effect on its operating results, liquidity or financial
position.
From time to time the Company may conclude it is in the best interests of its stockholders,
employees, and customers to settle one or more litigation matters, and any such settlement could
include substantial payments; however, other than as noted below, the Company has not reached this
conclusion with respect to any particular matter at this time. There are a variety of factors that
influence the Companys decisions to settle and the amount the Company may choose to pay, including
the strength of its case, developments in the litigation, the behavior of other interested parties,
the demand on management time and the possible distraction of the Companys employees associated
with the case and/or the possibility that the Company may be subject to an injunction or other
equitable remedy. It is difficult to predict whether a settlement is possible, the amount of an
appropriate settlement or when is the opportune time to settle a matter in light of the numerous
factors that go into the settlement decision. Unless otherwise specified below, any settlement
payment made pursuant to any of the completed settlement agreements described below is immaterial
to the Company for financial reporting purposes.
Stockholder Class Action Litigation
On October 3, 10 and 27, 2008, purported stockholder class action lawsuits styled Andrew Hall
v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01821-MHB); Steamfitters Local 449
Pension Fund v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01870-DKD); and Darlene
Oliver v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01964-JAT) were filed in the
United States District Court for the District of Arizona on behalf of stockholders who purchased
securities of the Company during the period between October 30, 2003 and approximately September
24, 2008. The Court consolidated these actions into a single proceeding and on May 18, 2009 an
amended complaint was filed alleging violations of the federal securities laws arising out of the
Companys restatement of its consolidated financial statements in 2008. On December 2, 2009, the
Court granted the Companys and other defendants dismissal motions and dismissed the consolidated
amended complaint without prejudice. On January 18, 2010 the lead plaintiff filed a second amended
complaint, and on or about August 9, 2010, the Court denied the Companys and other defendants
related dismissal motions. On December 17, 2010, the lead plaintiff filed a motion for class
certification, and the defendants filed an opposition to the motion on March 8, 2011. On June 6,
2011, the Company, certain of its current officers who are named in the complaint, and the
Companys outside auditors entered into a Memorandum of Understanding (the Class Action MOU) with
the
24
plaintiffs representatives to memorialize an agreement in principle to settle the pending
action. Under the terms of the settlement agreement, which remains subject to Court approval among
other customary conditions, the Companys portion of the settlement will be paid entirely by
insurance. The Companys outside auditors also will contribute to this settlement. The Company
itself is not required to make any payments to fund the settlement. The settlement agreement
contains no admission of liability by the Company or the named individuals in the action, the
allegations of which are expressly denied in the Class Action MOU. In the event the settlement is
not approved by the Court, the Company will continue to vigorously defend the claims in the class
action lawsuits. There can be no assurance that the Court will approve the settlement, or that the
Company will otherwise ultimately be successful in settling the lawsuits or in defending the
lawsuits, and an adverse resolution of the lawsuits could have a material adverse effect on the
Companys financial position and results of operations in the period in which the lawsuits are
resolved.
Stockholder Derivative Lawsuits
On January 21, 2009, the Company received a letter from an alleged stockholder demanding that
its Board of Directors take certain actions, including potentially legal action, in connection with
the restatement of its consolidated financial statements in 2008. The letter stated that, if the
Board of Directors did not take the demanded action, the alleged stockholder would commence a
derivative action on behalf of the Company. The Companys Board of Directors reviewed the letter
during the course of 2009 and established a special committee of the Board of Directors, comprised
of directors who are independent and disinterested with respect to the allegations in the letter,
to assess the allegations contained in the letter. The special committee engaged outside counsel
to assist with the investigation. The special committee completed its investigation, and on or
about February 16, 2010, the Board of Directors, pursuant to the report and recommendation of the
special committee, resolved to decline the derivative demand. On February 26, 2010, Company
counsel sent a declination letter to opposing counsel. On or about October 21, 2010, the
stockholder filed a derivative complaint against the Company and its directors and certain officers
in the Superior Court of the State of Arizona in and for the County of Maricopa, alleging that such
individuals breached their fiduciary duties to the Company in connection with the restatement. The
stockholder seeks to recover unspecified damages and costs, including counsel and expert fees.
On or about October 20, 2010, a second alleged stockholder of the Company filed a derivative
complaint against the Company and its directors and certain officers in the Superior Court of the
State of Arizona in and for the County of Maricopa. The complaint alleges, among other things,
that such individuals breached their fiduciary duties to the Company in connection with the
restatement. The complaint further alleges that a demand upon the Board of Directors to institute
an action in the Companys name would be futile and that the stockholder is therefore excused under
Delaware law from making such a demand prior to filing the complaint. The stockholder seeks, among
other things, to recover unspecified damages and costs, including counsel and expert fees.
On June 6, 2011, the Company and certain of its current officers and directors who are named
in the complaints entered into a Memorandum of Understanding (the Derivative Lawsuits MOU) with
the plaintiffs representatives to memorialize an agreement in principle to settle the pending
actions. The only financial component under the settlement agreement, which remains subject to
Court approval among other customary conditions, involves payment of plaintiffs attorneys fees,
which will be paid entirely by insurance. The Company itself is not required to make any payments
to fund the settlement. The settlement also reflects certain control and other enhancements taken
by the Company in connection with and subsequent to the restatement of its consolidated financial
statements in 2008. The settlement agreement contains no admission of liability by the Company or
the named individuals in the lawsuits, the allegations of which are expressly denied in the
Derivative Lawsuits MOU. In the event the settlement is not approved by the Court, the Company
will continue to vigorously defend the claims in the derivative lawsuits. There can be no
assurance that the Court will approve the settlement, or that the Company will otherwise ultimately
be successful in settling the lawsuits or in defending the lawsuits, and an adverse resolution of
the lawsuits could have a material adverse effect on the Companys financial position and results
of operations in the period in which the lawsuits are resolved.
Hyperion Arbitration
On June 23, 2011, Hyperion Therapeutics, Inc. (Hyperion) filed a demand for arbitration
before the American Arbitration Association for a judgment declaration of the rights and
obligations of Hyperion and Ucyclyd Pharma, Inc., a subsidiary of the Company (Ucyclyd), under a
collaboration agreement between the parties, dated August 23, 2007, as amended (the Collaboration
Agreement). Pursuant to the terms of the Collaboration
25
Agreement, Hyperion is responsible for the ongoing research and development of a compound
referred to as HPN-100 (formerly known as GT4P) for the treatment of urea cycle disorder, hepatic
encephalopathies and other indications. In addition, if certain specified conditions are
satisfied, then Hyperion will have certain purchase rights under the Collaboration Agreement with
respect to HPN-100, as well as Ucyclyds existing on-market products, AMMONUL® and
BUPHENYL®, and will be required to pay Ucyclyd royalties and regulatory and sales
milestone payments in connection with certain licenses that will be granted to Hyperion upon
exercise of the purchase rights. In its demand for arbitration, Hyperion requested a judgment
regarding the rights of the parties in connection with the development activities relating to
HPN-100, including relating to the submission of a NDA to the FDA for HPN-100 for the treatment of
urea cycle disorder. The Company responded to the demand for arbitration on July 28, 2011. In its
response, the Company denied the allegations of Hyperion and requested the arbitration panel deny
Hyperions requested declaratory relief. Additionally, the Company brought counterclaims against
Hyperion and sought a declaration of rights in the Companys favor and an award of damages.
In addition to the matters discussed above, in the ordinary course of business, the Company is
involved in a number of legal actions, both as plaintiff and defendant, and could incur uninsured
liability in any one or more of them. Although the outcome of these actions is not presently
determinable, it is the opinion of the Companys management, based upon the information available
at this time, that the expected outcome of these matters, individually or in the aggregate, will
not have a material adverse effect on the results of operations, financial condition or cash flows
of the Company.
18. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS
In May 2011, the FASB issued Accounting Standards Update (ASU) No. 2011-04, Amendments to
Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International
Financial Reporting Standards (Topic 820) Fair Value Measurement, to provide a consistent
definition of fair value and ensure that the fair value measurement and disclosure requirements are
similar between U.S. GAAP and International Financial Reporting Standards. ASU No. 2011-04 changes
certain fair value measurement principles and enhances the disclosure requirements, particularly
for level 3 fair value measurements. ASU No. 2011-04 is effective for interim and annual reporting
periods beginning after December 15, 2011 and must be applied prospectively. The Company is
currently assessing what impact, if any, the revised guidance will have on its results of
operations and financial condition.
In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation
of Comprehensive Income. The updated guidance amends the FASB Accounting Standards Codification
(Codification) to allow an entity the option to present the total of comprehensive income, the
components of net income, and the components of other comprehensive income either in a single
continuous statement of comprehensive income or in two separate but consecutive statements. In
both alternatives, an entity is required to present each component of net income along with total
net income, each component of other comprehensive income along with a total for other comprehensive
income, and a total amount for comprehensive income. ASU No. 2011-05 eliminates the option to
present the components of other comprehensive income as part of the statement of changes in
stockholders equity. The amendments to the Codification in the ASU do not change the items that
must be reported in other comprehensive income or when an item of other comprehensive income must
be reclassified to net income. ASU No. 2011-05 will be applied retrospectively. ASU No. 2011-05
is effective for annual reporting periods beginning after December 15, 2011, with early adoption
permitted, and will be applied retrospectively. It is expected that the adoption of this amendment
will only impact the presentation of comprehensive income within the Companys consolidated
financial statements.
19. SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the date of issuance of its financial
statements.
License and Settlement Agreement with Lupin
On July 21, 2011, the Company entered into a License and Settlement Agreement (the Settlement
Agreement) with Lupin Limited and Lupin Pharmaceuticals, Inc. (together, Lupin). Under the terms
of the Settlement Agreement, the Company agreed to grant to Lupin a future license to make and sell
its generic versions of SOLODYN® in 45mg, 90mg and 135mg strengths under the
SOLODYN® intellectual property rights belonging to the Company, with the license grant
effective November 26, 2011, or earlier under certain conditions. The
26
Company also agreed to grant to Lupin future licenses to make and sell its generic versions of
SOLODYN® in 65mg and 115mg strengths effective in February 2018, or earlier under
certain conditions, and its generic versions of SOLODYN® in 55mg (against which Lupins
Paragraph IV Patent Certification was the first received by the Company), 80mg and 105mg strengths
effective in February 2019, or earlier under certain conditions. The Settlement Agreement provides
that Lupin will be required to pay the Company royalties based on sales of Lupins generic
SOLODYN® products pursuant to the foregoing licenses.
Pursuant to the Settlement Agreement, the companies agreed to terminate all legal disputes
between them relating to SOLODYN®. In addition, Lupin confirmed that the Companys
patents relating to SOLODYN® are valid and enforceable, and cover Lupins activities
relating to Lupins generic SOLODYN® products under an ANDA. Lupin also agreed to be
permanently enjoined from any distribution of generic SOLODYN® products in the U.S.
except as described above.
On July 21, 2011, the Company entered into a Joint Development Agreement (the Joint
Development Agreement) with Lupin Limited, on behalf of itself and its affiliates (hereinafter
collectively referred to in this paragraph as Lupin), whereby the Company and Lupin will
collaborate to develop multiple novel proprietary therapeutic products. Pursuant to the Joint
Development Agreement, subject to the terms and conditions contained therein, the Company will make
an up-front $20 million payment to Lupin and will make additional payments to Lupin of up to $38
million upon the achievement of certain research, development, regulatory and other milestones, as
well as royalty payments on sales of the products covered under the agreement. In addition, the
Company will receive an exclusive, worldwide (excluding India) license on the sale of the products
covered under the Joint Development Agreement. The $20 million up-front payment will be recognized
as research and development expense during the three months ended September 30, 2011.
Stock Repurchase Plan
On August 8, 2011, the Company announced that its Board of Directors approved a Stock
Repurchase Plan to purchase up to $200 million in aggregate value of shares of Medicis Class A
common stock. Any repurchases will be made in compliance with the Securities and Exchange Commissions
Rule 10b-18.
The number of shares to be repurchased and the timing of repurchases (if any) will depend on a
variety of factors, including, but not limited to, stock price, economic and market conditions and
corporate and regulatory requirements. The plan does not obligate the Company to repurchase any
common stock. The plan is scheduled to terminate on the earlier of the first anniversary of the
plan or the time at which the purchase limit is reached, but may be suspended or terminated at any
time at the Companys discretion without prior notice.
27
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Executive Summary
We are a leading independent specialty pharmaceutical company focused primarily on helping
patients attain a healthy and youthful appearance and self-image through the development and
marketing in the U.S. of products for the treatment of dermatological and aesthetic conditions. We
also market products in Canada for the treatment of dermatological and aesthetic conditions and
began commercial efforts in Europe with our acquisition of LipoSonix in July 2008. We offer a
broad range of products addressing various conditions or aesthetics improvements, including facial
wrinkles, acne, fungal infections, hyperpigmentation, photoaging, psoriasis, seborrheic dermatitis
and cosmesis (improvement in the texture and appearance of skin).
Our current product lines are divided between the dermatological and non-dermatological
fields. The dermatological field represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological conditions. The non-dermatological field
represents products for the treatment of urea cycle disorder and contract revenue. Our acne and
acne-related dermatological product lines include SOLODYN® and ZIANA®.
During early 2011, we discontinued our TRIAZ® branded products and decided to no longer
promote our PLEXION® branded products. Our non-acne dermatological product lines
include DYSPORT®, LOPROX®, PERLANE®, RESTYLANE® and
VANOS®. Our non-dermatological product lines include AMMONUL® and
BUPHENYL®. Our non-dermatological field also includes contract revenues associated with
licensing agreements and authorized generic agreements.
Financial Information About Segments
We operate in one business segment: pharmaceuticals. Our current pharmaceutical franchises
are divided between the dermatological and non-dermatological fields. Information on revenues,
operating income, identifiable assets and supplemental revenue of our business franchises appears
in the condensed consolidated financial statements included in Item 1 hereof.
Key Aspects of Our Business
We derive a majority of our revenue from our primary products: DYSPORT®,
PERLANE®, RESTYLANE®, SOLODYN®, VANOS® and
ZIANA®. We believe that sales of our primary products will constitute a significant
portion of our revenue for 2011.
We have built our business by executing a four-part growth strategy: promoting existing
brands, developing new products and important product line extensions, entering into strategic
collaborations and acquiring complementary products, technologies and businesses. Our core
philosophy is to cultivate high integrity relationships of trust and confidence with the foremost
dermatologists and the leading plastic surgeons in the U.S. We rely on third parties to
manufacture our products (except for the LIPOSONIXTM system).
We estimate customer demand for our prescription products primarily through use of third party
syndicated data sources which track prescriptions written by health care providers and dispensed by
licensed pharmacies. The data represents extrapolations from information provided only by certain
pharmacies and are estimates of historical demand levels. We estimate customer demand for our
non-prescription products primarily through internal data that we compile. We observe trends from
these data and, coupled with certain proprietary information, prepare demand forecasts that are the
basis for purchase orders for finished and component inventory from our third party manufacturers
and suppliers. Our forecasts may fail to accurately anticipate ultimate customer demand for our
products. Overestimates of demand and sudden changes in market conditions may result in excessive
inventory production and underestimates may result in inadequate supply of our products in channels
of distribution.
We schedule our inventory purchases to meet anticipated customer demand. As a result,
miscalculation of customer demand or relatively small delays in our receipt of manufactured
products could result in revenues being deferred or lost. Our operating expenses are based upon
anticipated sales levels, and a high percentage of our operating expenses are relatively fixed in
the short term.
We sell our products primarily to major wholesalers and retail pharmacy chains. Approximately
75-80% of our gross revenues are typically derived from two major drug wholesale concerns.
Depending on the customer, we recognize revenue at the time of shipment to the customer, or at the
time of receipt by the customer, net of estimated
28
provisions. We recognize revenue on our aesthetics products DYSPORT®,
PERLANE® and RESTYLANE® upon shipment from McKesson, our exclusive U.S.
distributor of these products, to physicians. Consequently, variations in the timing of revenue
recognition could cause significant fluctuations in operating results from period to period and may
result in unanticipated periodic earnings shortfalls or losses. We have distribution services
agreements with our two largest wholesale customers. We review the supply levels of our
significant products sold to major wholesalers by reviewing periodic inventory reports that are
supplied to us by our major wholesalers in accordance with the distribution services agreements.
We rely wholly upon our wholesale and retail chain drugstore customers to effect the distribution
allocation of substantially all of our prescription products. We believe our estimates of trade
inventory levels of our products, based on our review of the periodic inventory reports supplied by
our major wholesalers and the estimated demand for our products based on prescription and other
data, are reasonable. We further believe that inventories of our products among wholesale
customers, taken as a whole, are similar to those of other specialty pharmaceutical companies, and
that our trade practices, which periodically involve volume discounts and early payment discounts,
are typical of the industry.
We periodically offer promotions to wholesale and retail 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 wholesale and drugstore
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 chain drugstore customers as may be necessary to
ensure the fullest possible distribution of our branded products within the pharmaceutical chain of
commerce. From time to time we may enter into business arrangements (e.g., loans or investments)
involving our customers and those arrangements may be reviewed by federal and state regulators.
Purchases by any given customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same period, resulting in fluctuations of
product inventory in the distribution channel. In addition, we consistently assess our product mix
and portfolio to promote a high level of profitability and revenues and to ensure that our products
are responsive to consumer tastes and changes to regulatory classifications. During early 2011, we
discontinued our TRIAZ® branded products and decided to no longer promote our
PLEXION® branded products.
Recent Developments
As described in more detail below, the following significant events and transactions occurred
during the six months ended June 30, 2011, and affected our results of operations, our cash flows
and our financial condition:
|
|
Research and development agreement with Anacor; |
|
|
|
Settlement Agreement with Teva; |
|
|
|
Classification of LipoSonix as a discontinued operation;
|
|
|
|
Increase of our quarterly dividend from $0.06 per share to $0.08 per share; |
|
|
|
Development milestone payment related to our collaboration with a privately-held U.S.
biotechnology
company; |
|
|
|
Issuance of new patent covering SOLODYN®; |
|
|
|
Settlement of class action and derivative lawsuits; and |
|
|
|
Establishment of a Supplemental Executive Retirement Plan. |
Research and development agreement with Anacor
On February 9, 2011, we entered into a research and development agreement with Anacor
Pharmaceuticals, Inc. (Anacor) for the discovery and development of boron-based small molecule
compounds directed against a target for the potential treatment of acne. Under the terms of the
agreement, we paid Anacor $7.0 million in connection with the execution of the agreement, and will
pay up to $153.0 million upon the achievement of certain research, development, regulatory and
commercial milestones, as well as royalties on sales by us. Anacor will be responsible for
discovering and conducting the early development of product candidates which utilize Anacors
proprietary boron chemistry platform, while we will have an option to obtain an exclusive license
for products
29
covered by the agreement. The initial $7.0 million payment was recognized as research and
development expense during the three months ended March 31, 2011.
Settlement Agreement with Teva
On February 24, 2011, we entered into a Settlement Agreement (Teva Settlement Agreement)
with Barr Laboratories, Inc., a subsidiary of Teva Pharmaceuticals USA, Inc., on behalf of itself
and certain of its affiliates, including Teva Pharmaceuticals USA, Inc. (collectively, Teva).
Under the terms of the Teva Settlement Agreement, we agreed to grant to Teva a future license to
make and sell our generic versions of SOLODYN® in 65mg and 115mg strengths under the
SOLODYN® intellectual property rights belonging to us, with the license grant effective
in February 2018, or earlier under certain conditions. We also agreed to grant to Teva a future
license to make and sell generic versions of SOLODYN® in 55mg, 80mg and 105mg strengths
under our SOLODYN® intellectual property rights, with the license grant effective in
February 2019, or earlier under certain conditions. The Teva Settlement Agreement provides that
Teva will be required to pay us royalties based on sales of Tevas generic SOLODYN®
products pursuant to the foregoing licenses. Pursuant to the Teva Settlement Agreement, the
companies agreed to terminate all legal disputes between them relating to SOLODYN®. In
addition, Teva confirmed that our patents relating to SOLODYN® are valid and
enforceable, and cover Tevas activities relating to Tevas generic SOLODYN® products
under ANDA No. 65-485 and any amendments and supplements thereto. Teva also agreed to be
permanently enjoined from any distribution of generic SOLODYN® products in the U.S.
except as described above. The United States District Court for the District of Maryland
subsequently entered a permanent injunction against any infringement by Teva.
Classification of LipoSonix as a discontinued operation
On February 25, 2011, we announced that as a result of our strategic planning process and the
current regulatory and commercial capital equipment environment, we determined to explore strategic
alternatives for our LipoSonix business including, but not limited to, the sale of the stand-alone
business. We have engaged Deutsche Bank to assist us in our exploration of strategic alternatives
for LipoSonix. As a result of this decision, we now classify the LipoSonix business as a
discontinued operation for financial statement reporting purposes.
Increase of our quarterly dividend from $0.06 per share to $0.08 per share
On March 22, 2011, we announced that our Board of Directors had declared a cash dividend of
$0.08 per issued and outstanding share of our Class A common stock, which was paid on April 29,
2011, to stockholders of record at the close of business on April 1, 2011. This represented a 33%
increase compared to our previous $0.06 dividend. A subsequent cash dividend announced in June
2011 was also at the rate of $0.08 per issued and outstanding share of our Class A common stock.
The dividend was paid on July 29, 2011 to stockholders of record at the close of business on July
1, 2011.
Development milestone payment related to our collaboration with a privately-held U.S. biotechnology
company
On September 10, 2010, we and a privately-held U.S. biotechnology company entered into a
sublicense and development agreement to develop an agent for specific dermatological conditions in
the Americas and Europe and a purchase option to acquire the privately-held U.S. biotechnology
company. Under the terms of the agreements, we paid the privately-held U.S. biotechnology company
$5.0 million in connection with the execution of the agreement, and will pay additional potential
milestone payments totaling approximately $100.5 million upon successful completion of certain
clinical, regulatory and commercial milestones.
During the three months ended June 30, 2011, a development milestone was achieved, and we made
a $5.5 million payment pursuant to the agreements. The $5.5 million milestone payment was
recognized as research and development expense during the three months ended June 30, 2011.
Issuance of new patent covering SOLODYN®
On April 5, 2011, the United States Patent and Trademark Office (USPTO) issued U.S. Patent
No. 7,919,483, entitled Method For The Treatment Of Acne (the 483 Patent) to us. The483
Patent, which expires in February 2027, covers methods of using a controlled-release oral dosage
form of minocycline to treat acne, including the use of our product SOLODYN®
in all eight currently available dosage forms. As previously reported,
30
the USPTO issued a Notice of Allowance for U.S. Application No. 11/166,817, the patent application
for the 483 Patent, in October 2009 and a second Notice of Allowance in April 2010 following the
completion of a Request for Continued Examination which we filed with the USPTO in November 2009.
Settlement of class action and derivative lawsuits
On June 6, 2011, we, certain of our current officers and directors named in the class action
and derivative lawsuits more fully described under Legal Matters in Note 17 in the notes to the
condensed consolidated financial statements, included in Part I, Item I of this Report, and our
outside auditors entered into Memoranda of Understanding (the MOUs) with the plaintiffs
representatives to memorialize an agreement in principle to settle the class action, as well as
both stockholder derivative lawsuits. Under the terms of these settlement agreements, which remain
subject to approval by the applicable courts among other customary conditions, our portion of the
class action settlement will be paid entirely by insurance. Our outside auditors also will
contribute to this settlement. The derivative lawsuits settlement, the only financial component of
which involves payment of plaintiffs attorneys fees, also will be paid entirely by insurance. We
are not required to make any payments to fund the settlements of the class action or the derivative
lawsuits. The settlement of the derivative lawsuits reflects certain control and other
enhancements undertaken by us in connection with and subsequent to the restatement of our
consolidated financial statements in 2008. The settlement agreements contain no admission of
liability by us or the named individuals in the respective actions, the allegations of which are
expressly denied in the MOUs.
Establishment of a Supplemental Executive Retirement Plan
On June 24, 2011, our Compensation Committee adopted the Medicis Pharmaceutical Supplemental
Executive Retirement Plan (the SERP), a non-qualified, noncontributory, defined benefit pension
plan that provides supplemental retirement income for a select group of officers, including our
named executive officers. The SERP is effective as of June 1, 2011. Retirement benefits are based
on a SERP participants years of service and average earnings (base salary plus cash bonus or
incentive payments) during any three calendar years of service (regardless of whether the years are
consecutive), beginning with the 2009 calendar year.
A SERP participant vests in 1/6th of his or her retirement benefit per plan year, effective as
of the first day of the plan year, and becomes fully vested in his or her accrued retirement
benefit upon (1) the participants normal retirement date, provided that the participant has at
least fifteen years of service with the Company and is employed by the Company on such date, (2)
the participants separation from service due to a discharge without cause or resignation for
good reason (as such terms are defined in the participants employment agreement, or in the
absence of such employment agreement or definitions, in the Companys Executive Retention Plan), or
(3) a change in control of the Company. A SERP participant accrues his or her retirement benefit
based on (x) the participants number of years of service with the Company (including prior years
of service), divided by (y) the number of years designated for such participants tier (which
ranges from five to twenty years).
Participants in the SERP received credit for prior service with us. The prior service accrued
benefit of approximately $33.8 million was recorded as other comprehensive income within
stockholders equity, and is amortized as compensation expense over the remaining service years of
each participant. Amortization of prior service costs recognized as compensation expense during
the three months ended June 30, 2011, was approximately $0.4 million, representing one month of
amortization. We also established a deferred tax asset of approximately $12.0 million, which was
also recorded as other comprehensive income.
Subsequent Events
License and Settlement Agreement with Lupin
On July 21, 2011, we entered into a License and Settlement Agreement (the Settlement
Agreement) with Lupin Limited and Lupin Pharmaceuticals, Inc. (together, Lupin). Under the
terms of the Settlement Agreement, we agreed to grant to Lupin a future license to make and sell
our generic versions of SOLODYN® in 45mg, 90mg and 135mg strengths under the
SOLODYN® intellectual property rights belonging to us, with the license grant effective
November 26, 2011, or earlier under certain conditions. We also agreed to grant to Lupin future
licenses to make and sell our generic versions of SOLODYN® in 65mg and 115mg strengths
effective in February 2018, or earlier under certain conditions, and our generic versions of
SOLODYN® in 55mg (against which Lupins Paragraph IV Patent Certification was the first
received by us), 80mg and 105mg strengths effective in
31
February 2019, or earlier under certain conditions. The Settlement Agreement provides that Lupin will be
required to pay us royalties based on sales of Lupins generic SOLODYN® products
pursuant to the foregoing licenses.
Pursuant to the Settlement Agreement, the companies agreed to terminate all legal disputes
between them relating to SOLODYN®. In addition, Lupin confirmed that our patents
relating to SOLODYN® are valid and enforceable, and cover Lupins activities relating to
Lupins generic SOLODYN® products under an ANDA. Lupin also agreed to be permanently
enjoined from any distribution of generic SOLODYN® products in the U.S. except as
described above.
On July 21, 2011, we entered into a Joint Development Agreement (the Joint Development
Agreement) with Lupin Limited, on behalf of itself and its affiliates (hereinafter collectively
referred to in this paragraph as Lupin), whereby we and Lupin will collaborate to develop
multiple novel proprietary therapeutic products. Pursuant to the Joint Development Agreement,
subject to the terms and conditions contained therein, we will make an up-front $20 million payment
to Lupin and will make additional payments to Lupin of up to $38 million upon the achievement of
certain research, development, regulatory and other milestones, as well as royalty payments on
sales of the products covered under the agreement. In addition, we will receive an exclusive,
worldwide (excluding India) license on the sale of the products covered under the Joint Development
Agreement. The $20 million up-front payment will be recognized as research and development expense
during the three months ended September 30, 2011.
Stock Repurchase Plan
On August 8, 2011, we
announced that our Board of Directors approved a Stock Repurchase Plan to purchase up to $200 million in aggregate value of shares of Medicis Class A common
stock. Any repurchases will be made in compliance with the Securities and Exchange Commissions Rule 10b-18.
The number of shares to be repurchased and the timing of repurchases (if any) will depend on a
variety of factors, including, but not limited to, stock price, economic and market conditions and
corporate and regulatory requirements. The plan does not obligate us to repurchase any common
stock. The plan is scheduled to terminate on the earlier of the first anniversary of the plan or
the time at which the purchase limit is reached, but may be suspended or terminated at any time at
our discretion without prior notice.
32
Results of Operations
The following table sets forth certain data as a percentage of net revenues for the periods
indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
(a |
) |
|
|
(b |
) |
|
|
(c |
) |
|
|
(d |
) |
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (e) |
|
|
90.4 |
|
|
|
90.6 |
|
|
|
90.8 |
|
|
|
90.7 |
|
Operating expenses |
|
|
59.1 |
|
|
|
52.7 |
|
|
|
61.5 |
|
|
|
52.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
31.3 |
|
|
|
37.9 |
|
|
|
29.3 |
|
|
|
38.5 |
|
Other expense, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.1 |
|
Interest and investment income
(expense), net |
|
|
0.1 |
|
|
|
(0.2 |
) |
|
|
0.1 |
|
|
|
(0.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from continuing operations before
income tax expense |
|
|
31.4 |
|
|
|
37.7 |
|
|
|
29.4 |
|
|
|
38.5 |
|
Income tax expense |
|
|
(13.4 |
) |
|
|
(14.2 |
) |
|
|
(12.2 |
) |
|
|
(14.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income from continuing operations |
|
|
18.0 |
|
|
|
23.5 |
|
|
|
17.2 |
|
|
|
24.0 |
|
Loss from discontinued operations, net of
income tax benefit |
|
|
(3.0 |
) |
|
|
(2.6 |
) |
|
|
(3.7 |
) |
|
|
(2.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
15.0 |
% |
|
|
20.9 |
% |
|
|
13.5 |
% |
|
|
21.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $5.5 million (2.9% of net revenues) paid related to a
product development agreement with a privately-held U.S. biotechnology company, $2.0 million
(1.0% of net revenues) paid to a Medicis partner related to a product development agreement
and $9.3 million (4.9% of net revenues) of compensation expense related to stock options,
restricted stock and stock appreciation rights. |
|
(b) |
|
Included in operating expenses is $2.1 million (1.2% of net revenues) of compensation expense
related to stock options, restricted stock and stock appreciation rights. |
|
(c) |
|
Included in operating expenses is $7.0 million (2.0% of net revenues) paid to Anacor related
to a product development agreement, $5.5 million (1.5% of net revenues) paid related to a
product development agreement with a privately-held U.S. biotechnology company, $2.0 million
(0.6% of net revenues) paid to a Medicis partner related to a product development agreement
and $16.0 million (4.5% of net revenues) of compensation expense related to stock options,
restricted stock and stock appreciation rights. |
|
(d) |
|
Included in operating expenses is $5.1 million (1.5% of net revenues) of compensation expense
related to stock options, restricted stock and stock appreciation rights. |
|
(e) |
|
Gross profit does not include amortization of the related intangibles as such expense is
included in operating expenses. |
33
Three Months Ended June 30, 2011 Compared to the Three Months Ended June 30, 2010
Net Revenues
The following table sets forth our net revenues for the three months ended June 30, 2011 (the
second quarter of 2011) and June 30, 2010 (the second quarter of 2010), along with the
percentage of net revenues and percentage point change for each of our product categories (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
Second Quarter |
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
$ Change |
|
|
% Change |
|
|
Net product revenues |
|
$ |
189.8 |
|
|
$ |
171.7 |
|
|
$ |
18.1 |
|
|
|
10.5 |
% |
Net contract revenues |
|
|
1.0 |
|
|
|
1.9 |
|
|
|
(0.9 |
) |
|
|
(47.4) |
% |
|
|
|
Total net revenues |
|
$ |
190.8 |
|
|
$ |
173.6 |
|
|
$ |
17.2 |
|
|
|
9.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
Second Quarter |
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
$ Change |
|
|
% Change |
|
|
Acne and acne-related
dermatological products |
|
$ |
123.1 |
|
|
$ |
124.8 |
|
|
$ |
(1.7 |
) |
|
|
(1.4) |
% |
Non-acne dermatological
products |
|
|
57.7 |
|
|
|
41.0 |
|
|
|
16.7 |
|
|
|
40.7 |
% |
Non-dermatological products
(including contract revenues) |
|
|
10.0 |
|
|
|
7.8 |
|
|
|
2.2 |
|
|
|
28.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
190.8 |
|
|
$ |
173.6 |
|
|
$ |
17.2 |
|
|
|
9.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
Second Quarter |
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
Change |
|
|
Acne and acne-related
dermatological products |
|
|
64.5 |
% |
|
|
71.9 |
% |
|
|
(7.4) |
% |
Non-acne dermatological
products |
|
|
30.3 |
% |
|
|
23.6 |
% |
|
|
6.7 |
% |
Non-dermatological products
(including contract revenues) |
|
|
5.2 |
% |
|
|
4.5 |
% |
|
|
0.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
Net revenues associated with our acne and acne-related dermatological products decreased by
$1.7 million, or 1.4%, during the second quarter of 2011 as compared to the second quarter of 2010,
primarily due to a decrease in sales of TRIAZ®, partially offset by increases in sales
of SOLODYN® and ZIANA®. The decrease in net revenues of TRIAZ®
was primarily due to our early 2011 discontinuation of TRIAZ® as a result of the FDAs
requirement that, effective March 4, 2011, prescription benzoyl peroxide products that are not
approved through a New Drug Application, such as TRIAZ®, not be sold as prescription
products. The increase in net revenues of SOLODYN® was primarily the result of an
increase in gross sales of SOLODYN® due to increased demand and the FDA approval of new
55mg, 80mg and 105mg strengths of SOLODYN® on August 27, 2010. The increase in net
revenues of ZIANA® was primarily the result of an increase in gross sales of
ZIANA®. We also reversed reserves during the second quarter of 2011 of $3.9 million
that were originally recorded during the first quarter of 2011 related to a targeted recall of
the product as a result of a notice we received during April 2011 from our contract manufacturer
regarding one lot of ZIANA® that went out of specification, as the actual amount of
product subject to recall was less than previously estimated. However, this reserve reversal was offset by increased returns and related reserve adjustments on the legacy products within this category.
34
Net revenues associated with our non-acne dermatological products increased by $16.7 million,
or 40.7%, during the second quarter of 2011 as compared to the second quarter of 2010 primarily due
to increased sales of DYSPORT® and VANOS®.
Net revenues associated with our non-dermatological products increased by $2.2 million, or
28.2%, during the second quarter of 2011 as compared to the second quarter of 2010 primarily due to
an increase in sales of BUPHENYL®, partially offset by a decrease in contract revenues.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our acquisition cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to products sold is not included in gross profit. Amortization expense related to these
intangibles for the second quarter of 2011 and 2010 was approximately $5.3 million and $5.2
million, respectively. Product mix plays a significant role in our quarterly and annual gross
profit as a percentage of net revenues. Different products generate different gross profit
margins, and the relative sales mix of higher gross profit products and lower gross profit products
can affect our total gross profit.
The following table sets forth our gross profit for the second quarter of 2011 and 2010, along
with the percentage of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
Second Quarter |
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
$ Change |
|
|
% Change |
|
|
Gross profit |
|
$ |
172.6 |
|
|
$ |
157.3 |
|
|
$ |
15.3 |
|
|
|
9.7 |
% |
% of net revenues |
|
|
90.4 |
% |
|
|
90.6 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the second quarter of 2011 as compared to the second
quarter of 2010 is primarily due to the $17.2 million increase in net revenues.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the second
quarter of 2011 and 2010, along with the percentage of net revenues represented by selling, general
and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
Second Quarter |
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
$ Change |
|
|
% Change |
|
|
Selling, general and administrative |
|
$ |
90.4 |
|
|
$ |
77.1 |
|
|
$ |
13.3 |
|
|
|
17.3 |
% |
% of net revenues |
|
|
47.4 |
% |
|
|
44.4 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
8.7 |
|
|
$ |
2.1 |
|
|
$ |
6.6 |
|
|
|
314.3 |
% |
Selling, general and administrative expenses increased $13.3 million, or 17.3%, during the
second quarter of 2011 as compared to the second quarter of 2010, and increased as a percentage of
net revenues from 44.4% during the second quarter of 2010 to 47.4% during the second quarter of
2011. Included in this increase was a $10.3 million increase in personnel expenses, including a
$6.6 million increase in stock compensation expense, primarily related to the revaluation of stock
appreciation rights (SARs) awards based on changes in the market price of our common stock, a
$3.6 million increase in promotion costs and a decrease of $0.6 million of other selling, general
and administrative costs.
35
Research and Development Expenses
The following table sets forth our research and development expenses for the second quarter of
2011 and 2010 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter |
|
|
Second Quarter |
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
$ Change |
|
|
% Change |
|
|
Research and development |
|
$ |
15.2 |
|
|
$ |
7.4 |
|
|
$ |
7.8 |
|
|
|
105.4 |
% |
Charges included in
research
and development |
|
$ |
7.5 |
|
|
$ |
|
|
|
$ |
7.5 |
|
|
|
100.0 |
% |
Share-based compensation
expense included in
research and development |
|
$ |
0.6 |
|
|
$ |
0.1 |
|
|
$ |
0.5 |
|
|
|
500.0 |
% |
Included in research and development expenses for the second quarter of 2011 was a $5.5
million payment related to a product development agreement with a privately-held U.S. biotechnology
company and $2.0 million paid to a Medicis partner related to a product development agreement. We
expect research and development expenses to continue to fluctuate from quarter to quarter based on
the timing of the achievement of development milestones under license and development agreements,
as well as the timing of other development projects and the funds available to support these
projects.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the second quarter of 2011 were $7.1 million, as
compared to $6.9 million during the second quarter of 2010, primarily due to increased depreciation
expense for property and equipment.
Interest and Investment Income
Interest and investment income during the second quarter of 2011 increased $0.4 million, or
58.8%, to $1.2 million from $0.8 million during the second quarter of 2010, due to an increase in
the amount of funds available for investment during the second quarter of 2011.
Interest Expense
Interest expense during each of the second quarter of 2011 and the second quarter of 2010 was
$1.1 million. Our interest expense during the second quarter of 2011 and 2010 consisted of
interest expense on our Old Notes, which accrue interest at 2.5% per annum, and our New Notes,
which accrue interest at 1.5% per annum. In addition, during the second quarter of 2011,
approximately $0.1 million of contingent interest was accrued related to our Old Notes. See Note
12 in our accompanying condensed consolidated financial statements for further discussion on the
Old Notes and New Notes.
Income Tax Expense
Our effective tax rate for continuing operations for the second quarter of 2011 was 42.5%, as
compared to 37.6% for the second quarter of 2010. The effective tax rate for the second quarter of
2011 reflects the impact of the non-deductibility of a $5.5 million milestone payment associated
with a product development agreement with a privately-held U.S. biotechnology company.
Loss from Discontinued Operations, Net of Income Tax Benefit
Loss from discontinued operations, net of income tax benefit, was $5.7 million during the
second quarter of 2011, as compared to $4.4 million during the second quarter of 2010. See Note 2
in our accompanying condensed consolidated financial statements for further discussion.
36
Six Months Ended June 30, 2011 Compared to the Six Months Ended June 30, 2010
Net Revenues
The following table sets forth our net revenues for the six months ended June 30, 2011 (the
2011 six months) and June 30, 2010 (the 2010 six months), along with the percentage of net
revenues and percentage point change for each of our product categories (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Six |
|
|
2010 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
% Change |
|
|
Net product revenues |
|
$ |
353.7 |
|
|
$ |
335.3 |
|
|
$ |
18.4 |
|
|
|
5.5 |
% |
Net contract revenues |
|
|
2.0 |
|
|
|
3.8 |
|
|
|
(1.8 |
) |
|
|
(47.4) |
% |
|
|
|
Total net revenues |
|
$ |
355.7 |
|
|
$ |
339.1 |
|
|
$ |
16.6 |
|
|
|
4.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Six |
|
|
2010 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
% Change |
|
|
Acne and acne-related
dermatological products |
|
$ |
226.6 |
|
|
$ |
245.0 |
|
|
$ |
(18.4 |
) |
|
|
(7.5) |
% |
Non-acne dermatological
products |
|
|
109.9 |
|
|
|
75.2 |
|
|
|
34.7 |
|
|
|
46.1 |
% |
Non-dermatological products
(including contract revenues) |
|
|
19.2 |
|
|
|
18.9 |
|
|
|
0.3 |
|
|
|
1.6 |
% |
|
|
|
Total net revenues |
|
$ |
355.7 |
|
|
$ |
339.1 |
|
|
$ |
16.6 |
|
|
|
4.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Six |
|
|
2010 Six |
|
|
|
|
|
|
Months |
|
|
Months |
|
|
Change |
|
|
Acne and acne-related
dermatological products |
|
|
63.7 |
% |
|
|
72.2 |
% |
|
|
(8.5) |
% |
Non-acne dermatological
products |
|
|
30.9 |
% |
|
|
22.2 |
% |
|
|
8.7 |
% |
Non-dermatological products
(including contract revenues) |
|
|
5.4 |
% |
|
|
5.6 |
% |
|
|
(0.2) |
% |
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
% |
|
|
|
Net revenues associated with our acne and acne-related dermatological products decreased by
$18.4 million, or 7.5%, during the 2011 six months as compared to the 2010 six months primarily as
a result of a decrease in net revenues of TRIAZ®. The decrease in net revenues of
TRIAZ® was primarily due to our early 2011 discontinuation of TRIAZ® as a
result of the FDAs requirement that, effective March 4, 2011, prescription benzoyl peroxide
products that are not approved through a New Drug Application, such as TRIAZ®, not be
sold as prescription products.
Net revenues associated with our non-acne dermatological products increased by $34.7 million,
or 46.1%, during the 2011 six months as compared to the 2010 six months, primarily due to increased
sales of DYSPORT® and VANOS®.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our acquisition cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to products sold is not included in gross profit. Amortization
37
expense related to these intangibles for the 2011 six months and 2010 six months was
approximately $10.7 million and $10.4 million, respectively. Product mix plays a significant role
in our quarterly and annual gross profit as a percentage of net revenues. Different products
generate different gross profit margins, and the relative sales mix of higher gross profit products
and lower gross profit products can affect our total gross profit.
The following table sets forth our gross profit for the 2011 six months and 2010 six months,
along with the percentage of net revenues represented by such gross profit (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Six |
|
|
2010 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
% Change |
|
|
Gross profit |
|
$ |
323.2 |
|
|
$ |
307.7 |
|
|
$ |
15.5 |
|
|
|
5.0 |
% |
% of net revenues |
|
|
90.8 |
% |
|
|
90.7 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during the 2011 six months as compared to the 2010 six months is
primarily due to the $16.6 million increase in net revenues.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the 2011
six months and 2010 six months, along with the percentage of net revenues represented by selling,
general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Six |
|
|
2010 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
% Change |
|
|
Selling, general and administrative |
|
$ |
175.0 |
|
|
$ |
149.4 |
|
|
$ |
25.6 |
|
|
|
17.1 |
% |
% of net revenues |
|
|
49.2 |
% |
|
|
44.0 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative expense |
|
$ |
15.0 |
|
|
$ |
5.0 |
|
|
$ |
10.0 |
|
|
|
200.0 |
% |
Selling, general and administrative expenses increased $25.6 million, or 17.1%, during the
2011 six months as compared to the 2010 six months, and increased as a percentage of net revenues
from 44.0% during the 2010 six months to 49.2% during the 2011 six months. Included in this
increase was an $18.8 million increase in personnel expenses, including a $10.0 million increase in
stock compensation expense, primarily related to the revaluation of SARs awards based on changes in
the market price of our common stock, a $2.6 million increase in promotion costs and an increase of
$4.2 million of other selling, general and administrative costs.
Research and Development Expenses
The following table sets forth our research and development expenses for the 2011 six months
and 2010 six months (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 Six |
|
|
2010 Six |
|
|
|
|
|
|
|
|
|
Months |
|
|
Months |
|
|
$ Change |
|
|
% Change |
|
|
Research and development |
|
$ |
29.5 |
|
|
$ |
14.0 |
|
|
$ |
15.5 |
|
|
|
110.7 |
% |
Charges included in
research
and development |
|
$ |
14.5 |
|
|
$ |
|
|
|
$ |
14.5 |
|
|
|
100.0 |
% |
Share-based compensation
expense included in
research and development |
|
$ |
1.0 |
|
|
$ |
0.1 |
|
|
$ |
0.9 |
|
|
|
900.0 |
% |
Included in research and development expenses for the 2011 six months was a $7.0 million
payment to Anacor related to a product development agreement, a $5.5 million payment related to a
product development agreement with a privately-held U.S. biotechnology company and $2.0 million
paid to a Medicis partner related to a
38
product development agreement. We expect research and development expenses to continue to
fluctuate from quarter to quarter based on the timing of the achievement of development milestones
under license and development agreements, as well as the timing of other development projects and
the funds available to support these projects.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the 2011 six months were $14.4 million, as
compared to $13.6 million during the 2010 six months, primarily due to increased depreciation
expense for property and equipment.
Interest and Investment Income
Interest and investment income during the 2011 six months increased $0.6 million, or 29.5%, to
$2.5 million from $1.9 million during the 2010 six months, due to an increase in the amount of
funds available for investment during the first half of 2011.
Interest Expense
Interest expense during the 2011 six months and the 2010 six months was $2.2 million and $2.1
million, respectively. Our interest expense during the 2011 six months and 2010 six months
consisted of interest expense on our Old Notes, which accrue interest at 2.5% per annum, and our
New Notes, which accrue interest at 1.5% per annum. In addition, during the 2011 six months,
approximately $0.1 million of contingent interest was accrued related to our Old Notes. See Note
12 in our accompanying condensed consolidated financial statements for further discussion on the
Old Notes and New Notes.
Other Expense, net
Other expense of $0.3 million recognized during the 2010 six months represented an
other-than-temporary impairment on an asset-backed security investment.
Income Tax Expense
Our effective tax rate for the 2011 six months was 41.5%, as compared to 37.9% for the 2010
six months. The effective tax rate for the 2011 six months reflects the impact of the
non-deductibility of a $5.5 million milestone payment associated with a product development
agreement with a privately-held U.S. biotechnology company.
Loss from Discontinued Operations, Net of Income Tax Benefit
Loss from discontinued operations, net of income tax benefit, was $13.1 million during the
2011 six months, as compared to $9.1 million during the 2010 six months. See Note 2 in our
accompanying condensed consolidated financial statements for further discussion.
39
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the second quarter of 2011
and 2010, and selected balance sheet components as of June 30, 2011 and December 31, 2010 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Six Months |
|
|
$ Change |
|
|
% Change |
|
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
72.6 |
|
|
$ |
60.0 |
|
|
$ |
12.6 |
|
|
|
21.0 |
% |
Investing activities |
|
|
(189.2 |
) |
|
|
(166.4 |
) |
|
|
(22.8 |
) |
|
|
(13.7) |
% |
Financing activities |
|
|
48.4 |
|
|
|
(3.5 |
) |
|
|
51.9 |
|
|
|
1,482.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
Dec. 31, 2010 |
|
|
$ Change |
|
|
% Change |
|
|
Cash, cash equivalents,
and short-term investments |
|
$ |
805.8 |
|
|
$ |
703.6 |
|
|
$ |
102.2 |
|
|
|
14.5 |
% |
Working capital |
|
|
507.2 |
|
|
|
628.4 |
|
|
|
(121.2 |
) |
|
|
(19.3) |
% |
Long-term investments |
|
|
22.4 |
|
|
|
21.5 |
|
|
|
0.9 |
|
|
|
4.2 |
% |
2.5% contingent convertible
senior notes due 2032 |
|
|
169.1 |
|
|
|
169.1 |
|
|
|
|
|
|
|
|
% |
1.5% contingent convertible
senior notes due 2033 |
|
|
0.2 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
% |
40
Working Capital
Working capital as of June 30, 2011 and December 31, 2010 consisted of the following (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2011 |
|
|
Dec. 31, 2010 |
|
|
$ Change |
|
|
% Change |
|
|
Cash, cash equivalents, and short-term investments |
|
$ |
805.8 |
|
|
$ |
703.6 |
|
|
$ |
102.2 |
|
|
|
14.5 |
% |
Accounts receivable, net |
|
|
166.4 |
|
|
|
130.6 |
|
|
|
35.8 |
|
|
|
27.4 |
% |
Inventories, net |
|
|
30.8 |
|
|
|
35.3 |
|
|
|
(4.5 |
) |
|
|
(12.7 |
)% |
Deferred tax assets, net |
|
|
24.6 |
|
|
|
70.5 |
|
|
|
(45.9 |
) |
|
|
(65.1 |
)% |
Other current assets |
|
|
19.3 |
|
|
|
15.2 |
|
|
|
4.1 |
|
|
|
27.0 |
% |
Assets held for sale from
discontinued operations |
|
|
10.2 |
|
|
|
13.1 |
|
|
|
(2.9 |
) |
|
|
(22.1 |
)% |
|
|
|
Total current assets |
|
|
1,057.1 |
|
|
|
968.3 |
|
|
|
88.8 |
|
|
|
9.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
45.4 |
|
|
|
41.0 |
|
|
|
4.4 |
|
|
|
10.7 |
% |
Current portion of contingent
convertible senior notes |
|
|
169.1 |
|
|
|
|
|
|
|
169.1 |
|
|
|
100.0 |
% |
Reserve for sales returns |
|
|
78.2 |
|
|
|
60.7 |
|
|
|
17.5 |
|
|
|
28.8 |
% |
Accrued consumer rebate and
loyalty programs |
|
|
124.9 |
|
|
|
101.7 |
|
|
|
23.2 |
|
|
|
22.8 |
% |
Managed care and Medicaid
reserves |
|
|
51.3 |
|
|
|
49.4 |
|
|
|
1.9 |
|
|
|
3.8 |
% |
Income taxes payable |
|
|
|
|
|
|
4.6 |
|
|
|
(4.6 |
) |
|
|
(100.0 |
)% |
Other current liabilities |
|
|
73.8 |
|
|
|
75.2 |
|
|
|
(1.4 |
) |
|
|
(1.9 |
)% |
Liabilities held for sale from
discontinued operations |
|
|
7.2 |
|
|
|
7.3 |
|
|
|
(0.1 |
) |
|
|
(1.4 |
)% |
|
|
|
Total current liabilities |
|
|
549.9 |
|
|
|
339.9 |
|
|
|
210.0 |
|
|
|
61.8 |
% |
|
|
|
Working capital |
|
$ |
507.2 |
|
|
$ |
628.4 |
|
|
$ |
(121.2 |
) |
|
|
(19.3 |
)% |
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $805.8 million and working capital
of $507.2 million at June 30, 2011, as compared to $703.6 million and $628.4 million, respectively,
at December 31, 2010. The increase in cash, cash equivalents and short-term investments was
primarily due to the generation of $72.6 million of operating cash flow and $54.0 million of
proceeds received from stock option exercises during the 2011 six months.
Accounts receivable, net, increased $35.8 million, or 27.4%, from $130.6 million at December
31, 2010 to $166.4 million at June 30, 2011. The increase was primarily due to a $44.8 million
increase in gross sales during the month of June 2011 as compared to the month of December 2010.
As our standard payment terms are 30 days, orders that occur during the last month of a quarter are
typically not due for payment until after the end of the quarter. Gross sales during the month of
June 2011 were $185.2 million, or 52.4% of the total gross sales for the second quarter of 2011, as
compared to gross sales during the month of December 2010 of $140.4 million, or 45.1% of total
gross sales for the fourth quarter of 2010. Days sales outstanding, calculated as accounts
receivable, net, as of the end of the reporting period, divided by total gross sales for the
quarter, multiplied by the number of days in the quarter, was 43 days as of June 30, 2011 as
compared to 39 days as of December 31, 2010. The increase in days sales outstanding was
primarily due to the timing of orders placed by customers during the second quarter of 2011 as
compared to the fourth quarter of 2010. Although more of the customers purchases during the
second quarter of 2011 occurred during the last month of the quarter as compared to the last month
of the fourth quarter of 2010, their total purchases for the second quarter of 2011 were consistent
with previous quarters. We sell our products primarily to major wholesalers and retail chain
drugstores. We have distribution services agreements with our two largest wholesale customers. We
review the supply levels of our significant products sold to major wholesalers by reviewing
periodic inventory reports that are supplied to us by our major wholesalers in accordance
41
with the distribution services agreements. We rely wholly upon our wholesale and retail chain
drugstore customers to effect the distribution allocation of substantially all of our prescription
products. We also defer the recognition of revenue for certain sales of inventory into the
distribution channel that are in excess of eight (8) weeks of projected demand, and we defer the
recognition of revenue of our aesthetics products DYSPORT®, PERLANE® and
RESTYLANE®, until our exclusive U.S. distributor, McKesson, ships these products to
physicians. There has not been a significant change in inventories in the distribution channel
during the quarter ended June 30, 2011.
Management believes existing cash and short-term investments, together with funds generated
from operations, should be sufficient to meet operating requirements for the foreseeable future.
Our cash and short-term investments are available for dividends, milestone payments related to our
product development collaborations, strategic investments, acquisitions of companies or products
complementary to our business, the repayment of outstanding indebtedness, repurchases of our
outstanding securities and other potential large-scale needs. In addition, we may consider
incurring additional indebtedness and issuing additional debt or equity securities in the future to
fund potential acquisitions or investments, to refinance existing debt or for general corporate
purposes. If a material acquisition or investment is completed, our operating results and
financial condition could change materially in future periods. However, no assurance can be given
that additional funds will be available on satisfactory terms, or at all, to fund such activities.
As of June 30, 2011, our short-term investments included $19.9 million of auction rate
floating securities. Our auction rate floating securities are debt instruments with a long-term
maturity and with an interest rate that is reset in short intervals through auctions. During the
three months ended March 31, 2008, we were informed that there was insufficient demand at auction
for the auction rate floating securities, and since that time we have been unable to liquidate our
holdings in such securities. As a result, these affected auction rate floating securities are now
considered illiquid, and we could be required to hold them until they are redeemed by the holder at
maturity or until a future auction on these investments is successful. During the 2011 six months,
we liquidated $2.0 million of our auction rate floating securities at par.
Operating Activities
Net cash provided by operating activities during the 2011 six months was approximately $72.6
million, compared to cash provided by operating activities of approximately $60.0 million during
the 2010 six months. The following is a summary of the primary components of cash provided by
operating activities during the 2011 six months and 2010 six months (in millions):
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
|
2010 |
|
|
|
Six Months |
|
|
Six Months |
|
|
Income taxes paid |
|
$ |
(38.0 |
) |
|
$ |
(47.7 |
) |
Payment made to Anacor related to development agreement |
|
|
(7.0 |
) |
|
|
|
|
Payment made related to development agreement with a privately-held
U.S. biotechnology company |
|
|
(5.5 |
) |
|
|
|
|
Payment made to a Medicis partner related to a development agreement |
|
|
(2.0 |
) |
|
|
|
|
Increase in accounts receivable |
|
|
(36.9 |
) |
|
|
(42.8 |
) |
Increase in reserve for returns |
|
|
17.5 |
|
|
|
1.1 |
|
Increase in accrued consumer rebates and loyalty programs |
|
|
23.2 |
|
|
|
17.1 |
|
Decrease in other current liabilities |
|
|
(17.3 |
) |
|
|
(2.3 |
) |
Cash used in operating activities from discontinued operations |
|
|
(10.0 |
) |
|
|
(5.3 |
) |
Other cash provided by operating activities |
|
|
148.6 |
|
|
|
139.9 |
|
|
|
|
Cash provided by operating activities |
|
$ |
72.6 |
|
|
$ |
60.0 |
|
|
|
|
Investing Activities
Net cash used in investing activities during the 2011 six months was approximately $189.2
million, compared to net cash used in investing activities during the 2010 six months of $166.4
million. The change was primarily due to the net purchases and sales of our short-term and
long-term investments during the respective periods.
42
Financing Activities
Net cash provided by financing activities during the 2011 six months was $48.4 million,
compared to net cash used in financing activities of $3.5 million during the 2010 six months.
Proceeds from the exercise of stock options were $54.0 million during the 2011 six months compared
to $2.2 million during the 2010 six months. Dividends paid during the 2011 six months were $8.5
million and dividends paid during the 2010 six months were $6.0 million.
Contingent Convertible Senior Notes and Other Long-Term Commitments
We have two outstanding series of Contingent Convertible Senior Notes, consisting of $169.1
million principal amount of 2.5% Contingent Convertible Senior Notes due 2032 (the Old Notes) and
$0.2 million principal amount of 1.5% Contingent Convertible Senior Notes due 2033 (the New
Notes). The New Notes and the Old Notes are unsecured and do not contain any restrictions on the
incurrence of additional indebtedness or the repurchase of our securities, and do not contain any
financial covenants. The Old Notes do not contain any restrictions on the payment of dividends.
The New Notes require an adjustment to the conversion price if the cumulative aggregate of all
current and prior dividend increases above $0.025 per share would result in at least a one percent
(1%) increase in the conversion price. This threshold has not been reached and no adjustment to
the conversion price has been made.
On June 4, 2012 and 2017, or upon the occurrence of a change in control, holders of the Old
Notes may require us to offer to repurchase their Old Notes for cash. On June 4, 2013 and 2018, or
upon the occurrence of a change in control, holders of the New Notes may require us to offer to
repurchase their New Notes for cash. Under GAAP, if an obligation is due on demand or will be due
on demand within one year from the balance sheet date, even though liquidation may not be expected
within that period, it should be classified as a current liability. Accordingly, the outstanding
balance of Old Notes along with the deferred tax liability associated with accelerated interest
deductions on the Old Notes will be classified as a current liability during the respective twelve
month periods prior to June 4, 2012 and June 4, 2017. As of June 30, 2011, $169.1 million of the
Old Notes and $57.9 million of deferred tax liabilities were classified as current liabilities in
our condensed consolidated balance sheets. The $57.9 million of deferred tax liabilities were
included within current deferred tax assets, net. If all of the Old Notes are put back to us on
June 4, 2012, we would be required to pay $169.1 million in outstanding principal, plus accrued
interest. We would also be required to pay the accumulated deferred tax liability related to the
Old Notes.
During the quarter ended June 30, 2011, 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 the 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 quarter ended June 30, 2011. The holders of Old Notes
have this conversion right only until September 30, 2011. At the end of each future quarter, the
conversion rights will be reassessed in accordance with the bond indenture agreement to determine
if the conversion trigger rights have been achieved. During the quarter ended June 30, 2011, the
New Notes did not meet the criteria for the right of conversion.
Except for the New Notes, we had only $39.0 million of long-term liabilities at June 30, 2011,
and, except for the Old Notes, we had $380.7 million of current liabilities at June 30, 2011. 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.
Dividends
We do not have a dividend policy. Prior to July 2003, we had not paid a cash dividend on our
common stock. Since July 2003, we have paid quarterly cash dividends aggregating approximately
$68.4 million on our common stock. In addition, on June 8, 2011, we announced that our Board of
Directors had declared a cash dividend of $0.08 per issued and outstanding share of common stock,
which was paid on July 29, 2011, to our stockholders of record at the close of business on July 1,
2011. 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.
43
Fair Value Measurements
We utilize unobservable (Level 3) inputs in determining the fair value of our auction rate
floating security investments, which totaled $19.9 million at June 30, 2011. These securities were
included in long-term investments at June 30, 2011.
Our auction rate floating securities are classified as available-for-sale securities and are
reflected at fair value. In prior periods, due to the auction process which took place every 30-35
days for most securities, quoted market prices were readily available, which would qualify as Level
1 under ASC 820, Fair Value Measurements and Disclosure. However, due to events in credit markets
that began during the first quarter of 2008, the auction events for most of these instruments
failed, and, therefore, we determined the estimated fair values of these securities, beginning in
the first quarter of 2008, utilizing a discounted cash flow analysis. These analyses consider,
among other items, the collateralization underlying the security investments, the expected future
cash flows, including the final maturity, associated with the securities, and the expectation of
the next time the security is expected to have a successful auction. These securities were also
compared, when possible, to other observable market data with similar characteristics to the
securities held by us. Due to these events, we reclassified these instruments as Level 3 during
the first quarter of 2008.
Off-Balance Sheet Arrangements
As of June 30, 2011, we are not involved in any off-balance sheet arrangements, as defined in
Item 303(a)(4)(ii) of Securities and Exchange Commission (SEC) Regulation S-K.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based
upon our condensed consolidated financial statements, which have been prepared in conformity with
U.S. generally accepted accounting principles. The preparation of the condensed consolidated
financial statements requires us to make estimates and assumptions that affect the amounts reported
in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, we
evaluate our estimates related to sales allowances, chargebacks, rebates, returns and other pricing
adjustments, depreciation and amortization and other contingencies and litigation. We base our
estimates on historical experience and various other factors related to each circumstance. Actual
results could differ from those estimates based upon future events, which could include, among
other risks, changes in the regulations governing the manner in which we sell our products, changes
in the health care environment and managed care consumption patterns. Our significant accounting
policies are described in Note 2 to the consolidated financial statements included in our Form 10-K
for the year ended December 31, 2010. There were no new significant accounting estimates in the
second quarter of 2011, nor were there any material changes to the critical accounting policies and
estimates discussed in our Form 10-K for the year ended December 31, 2010.
Items Deducted From Gross Revenue
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, inventory in the distribution channel, cash
discounts, chargebacks, managed care and Medicaid rebates and consumer rebate and loyalty programs
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.
44
The following table shows the activity of each reserve, associated with the various sales
provisions that serve to reduce our accounts receivable balance or increase our accrued expenses or
deferred revenue, for the three months ended June 30, 2011 and 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care & |
|
|
Rebate |
|
|
|
|
|
|
Reserve |
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
Medicaid |
|
|
and |
|
|
|
|
|
|
for Sales |
|
|
Deferred |
|
|
Discounts |
|
|
Chargebacks |
|
|
Rebates |
|
|
Loyalty |
|
|
|
|
|
|
Returns |
|
|
Revenue |
|
|
Reserve |
|
|
Reserve |
|
|
Reserve |
|
|
Programs |
|
|
Total |
|
|
Balance at Mar. 31,
2011 |
|
$ |
73,802 |
|
|
$ |
4,217 |
|
|
$ |
2,351 |
|
|
$ |
1,122 |
|
|
$ |
49,156 |
|
|
$ |
121,704 |
|
|
$ |
252,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual |
|
|
(13,069 |
) |
|
|
|
|
|
|
(5,667 |
) |
|
|
(1,560 |
) |
|
|
(22,210 |
) |
|
|
(108,559 |
) |
|
|
(151,065 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision |
|
|
17,487 |
|
|
|
(1,776 |
) |
|
|
6,971 |
|
|
|
1,927 |
|
|
|
24,293 |
|
|
|
111,777 |
|
|
|
160,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30,
2011 |
|
$ |
78,220 |
|
|
$ |
2,441 |
|
|
$ |
3,655 |
|
|
$ |
1,489 |
|
|
$ |
51,239 |
|
|
$ |
124,922 |
|
|
$ |
261,966 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care & |
|
|
Rebate |
|
|
|
|
|
|
Reserve |
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
Medicaid |
|
|
and |
|
|
|
|
|
|
for Sales |
|
|
Deferred |
|
|
Discounts |
|
|
Chargebacks |
|
|
Rebates |
|
|
Loyalty |
|
|
|
|
|
|
Returns |
|
|
Revenue |
|
|
Reserve |
|
|
Reserve |
|
|
Reserve |
|
|
Programs |
|
|
Total |
|
|
Balance at Mar. 31,
2010 |
|
$ |
43,716 |
|
|
$ |
2,561 |
|
|
$ |
2,365 |
|
|
$ |
1,148 |
|
|
$ |
48,964 |
|
|
$ |
94,582 |
|
|
$ |
193,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual |
|
|
(8,455 |
) |
|
|
|
|
|
|
(5,185 |
) |
|
|
(1,028 |
) |
|
|
(26,517 |
) |
|
|
(77,011 |
) |
|
|
(118,196 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision |
|
|
13,933 |
|
|
|
(1,254 |
) |
|
|
5,778 |
|
|
|
801 |
|
|
|
21,963 |
|
|
|
72,793 |
|
|
|
114,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30,
2010 |
|
$ |
49,194 |
|
|
$ |
1,307 |
|
|
$ |
2,958 |
|
|
$ |
921 |
|
|
$ |
44,410 |
|
|
$ |
90,364 |
|
|
$ |
189,154 |
|
|
|
|
The provision for product returns was $17.5 million, or 5.0% of gross product sales, and
$13.9 million, or 4.8% of gross product sales, for the three months ended June 30, 2011 and 2010,
respectively. The reserve for product returns increased $4.4 million, from $73.8 million as of
March 31, 2011 to $78.2 million as of June 30, 2011. The increase in the provision during the
comparable periods and in the reserve during the three months ended June 30, 2011 was primarily
related to additional estimated required reserves for newly-launched products.
The provision for cash discounts was $7.0 million, or 2.0% of gross product sales, and $5.8
million, or 2.0% of gross product sales, for the three months ended June 30, 2011 and 2010,
respectively. The reserve for cash discounts increased $1.3 million, from $2.4 million as of March
31, 2011 to $3.7 million as of June 30, 2011. The increase in the provision during the comparable
periods was due to an increase in gross product sales. The balance in the reserve for sales
discounts at the end of a quarterly period is related to the amount of accounts receivable that is
outstanding at that date that is still eligible for the cash discounts to be taken by the
customers. The fluctuation in the reserve for sales discounts between periods is normally
reflective of increases or decreases in the related eligible outstanding accounts receivable
amounts at the comparable dates.
The provision for consumer rebates and loyalty programs was $111.8 million, or 31.8% of gross
product sales, and $72.8 million, or 25.0% of gross product sales, for the three months ended June
30, 2011 and 2010,
45
respectively. The reserve for consumer rebates and loyalty programs increased $3.2 million,
from $121.7 million as of March 31, 2011 to $124.9 million as of June 30, 2011. The increase in
the provision during the comparable periods and in the reserve during the three months ended June
30, 2011 was primarily due to the continued growth in consumer rebate programs related to our
SOLODYN®, ZIANA® RESTYLANE® and PERLANE® products.
The following table shows the activity of each reserve, associated with the various sales
provisions that serve to reduce our accounts receivable balance or increase our accrued expenses or
deferred revenue, for the six months ended June 30, 2011 and 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care & |
|
|
Rebate |
|
|
|
|
|
|
Reserve |
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
Medicaid |
|
|
and |
|
|
|
|
|
|
for Sales |
|
|
Deferred |
|
|
Discounts |
|
|
Chargebacks |
|
|
Rebates |
|
|
Loyalty |
|
|
|
|
|
|
Returns |
|
|
Revenue |
|
|
Reserve |
|
|
Reserve |
|
|
Reserve |
|
|
Programs |
|
|
Total |
|
|
Balance at Dec. 31,
2010 |
|
$ |
60,692 |
|
|
$ |
582 |
|
|
$ |
2,830 |
|
|
$ |
1,151 |
|
|
$ |
49,375 |
|
|
$ |
101,678 |
|
|
$ |
216,308 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual |
|
|
(25,097 |
) |
|
|
|
|
|
|
(12,724 |
) |
|
|
(2,834 |
) |
|
|
(47,439 |
) |
|
|
(189,182 |
) |
|
|
(277,276 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision |
|
|
42,625 |
|
|
|
1,859 |
|
|
|
13,549 |
|
|
|
3,172 |
|
|
|
49,303 |
|
|
|
212,426 |
|
|
|
322,934 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30,
2011 |
|
$ |
78,220 |
|
|
$ |
2,441 |
|
|
$ |
3,655 |
|
|
$ |
1,489 |
|
|
$ |
51,239 |
|
|
$ |
124,922 |
|
|
$ |
261,966 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care & |
|
|
Rebate |
|
|
|
|
|
|
Reserve |
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
Medicaid |
|
|
and |
|
|
|
|
|
|
for Sales |
|
|
Deferred |
|
|
Discounts |
|
|
Chargebacks |
|
|
Rebates |
|
|
Loyalty |
|
|
|
|
|
|
Returns |
|
|
Revenue |
|
|
Reserve |
|
|
Reserve |
|
|
Reserve |
|
|
Programs |
|
|
Total |
|
|
Balance at Dec. 31,
2009 |
|
$ |
48,062 |
|
|
$ |
1,263 |
|
|
$ |
2,160 |
|
|
$ |
688 |
|
|
$ |
47,078 |
|
|
$ |
73,311 |
|
|
$ |
172,562 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual |
|
|
(13,008 |
) |
|
|
|
|
|
|
(10,397 |
) |
|
|
(2,181 |
) |
|
|
(47,790 |
) |
|
|
(129,981 |
) |
|
|
(203,357 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision |
|
|
14,140 |
|
|
|
44 |
|
|
|
11,195 |
|
|
|
2,414 |
|
|
|
45,122 |
|
|
|
147,034 |
|
|
|
219,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30,
2010 |
|
$ |
49,194 |
|
|
$ |
1,307 |
|
|
$ |
2,958 |
|
|
$ |
921 |
|
|
$ |
44,410 |
|
|
$ |
90,364 |
|
|
$ |
189,154 |
|
|
|
|
The provision for product returns was $42.6 million, or 6.2% of gross product sales, and
$14.1 million, or 2.5% of gross product sales, for the six months ended June 30, 2011 and 2010,
respectively. The reserve for product returns increased $17.5 million, from $60.7 million as of
December 31, 2010 to $78.2 million as of June 30, 2011. The increase in the provision during the
comparable periods and in the reserve during the six months ended June 30, 2011 was primarily
related to additional estimated required reserves for newly-launched products.
The provision for cash discounts was $13.5 million, or 2.0% of gross product sales, and $11.2
million, or 2.0% of gross product sales, for the six months ended June 30, 2011 and 2010,
respectively. The reserve for cash discounts increased $0.9 million, from $2.8 million as of
December 31, 2010 to $3.7 million as of June 30, 2011. The increase in the provision during the
comparable periods was due to an increase in gross product sales.
The provision for consumer rebates and loyalty programs was $212.4 million, or 30.7% of gross
product sales, and $147.0 million, or 25.9% of gross product sales, for the six months ended June
30, 2011 and 2010,
46
respectively. The reserve for consumer rebates and loyalty programs increased $23.2 million,
from $101.7 million as of December 31, 2010 to $124.9 million as of June 30, 2011. The increase
in the provision during the comparable periods and in the reserve during the six months ended June
30, 2011 was primarily due to the continued growth in consumer rebate programs related to our
SOLODYN®, ZIANA® RESTYLANE® and PERLANE® products.
Recent Accounting Pronouncements
In May 2011, the FASB issued Accounting Standards Update (ASU) No. 2011-04, Amendments to
Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and International
Financial Reporting Standards (Topic 820) Fair Value Measurement, to provide a consistent
definition of fair value and ensure that the fair value measurement and disclosure requirements are
similar between U.S. GAAP and International Financial Reporting Standards. ASU No. 2011-04 changes
certain fair value measurement principles and enhances the disclosure requirements, particularly
for level 3 fair value measurements. ASU No. 2011-04 is effective for interim and annual reporting
periods beginning after December 15, 2011 and must be applied prospectively. We are currently
assessing what impact, if any, the revised guidance will have on our results of operations and
financial condition.
In June 2011, the FASB issued ASU No. 2011-05, Comprehensive Income (Topic 220): Presentation
of Comprehensive Income. The updated guidance amends the FASB Accounting Standards Codification
(Codification) to allow an entity the option to present the total of comprehensive income, the
components of net income, and the components of other comprehensive income either in a single
continuous statement of comprehensive income or in two separate but consecutive statements. In
both alternatives, an entity is required to present each component of net income along with total
net income, each component of other comprehensive income along with a total for other comprehensive
income, and a total amount for comprehensive income. ASU No. 2011-05 eliminates the option to
present the components of other comprehensive income as part of the statement of changes in
stockholders equity. The amendments to the Codification in the ASU do not change the items that
must be reported in other comprehensive income or when an item of other comprehensive income must
be reclassified to net income. ASU No. 2011-05 will be applied retrospectively. ASU No. 2011-05
is effective for annual reporting periods beginning after December 15, 2011, with early adoption
permitted, and will be applied retrospectively. It is expected that the adoption of this amendment
will only impact the presentation of comprehensive income within our consolidated financial
statements.
Forward Looking Statements
This Quarterly Report on Form 10-Q and other documents we file with the SEC include
forward-looking statements. These include statements relating to future actions, prospective
products or product approvals, future performance or results of current and anticipated products,
sales and marketing efforts, expenses, the outcome of contingencies, such as legal proceedings, and
financial results. From time to time, we also may make forward-looking statements in press
releases or written statements, or in our communications and discussions with investors and
analysts in the normal course of business through meetings, webcasts, phone calls and conference
calls. All statements other than statements of historical fact are, or may be deemed to be,
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act).
These statements are based on certain assumptions made by us based on our experience and perception
of historical trends, current conditions, expected future developments and other factors we believe
are appropriate in the circumstances. We caution you that actual outcomes and results may differ
materially from what is expressed, implied or forecast by our forward-looking statements. Such
statements are subject to a number of assumptions, risks and uncertainties, many of which are
beyond our control. You can identify these statements by the fact that they do not relate strictly
to historical or current facts. They use words such 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:
|
|
development and launch of new competitive products, including over-the-counter or generic
competitor products; |
|
|
|
the ability to compete against generic and other branded products; |
47
|
|
increases or decreases in the expected costs to be incurred in connection with the
research and development, clinical trials, regulatory approvals, commercialization and
marketing of our products; |
|
|
|
the success of research and development activities, including the development of additional
forms of SOLODYN®, and our ability to obtain regulatory approvals; |
|
|
|
the speed with which regulatory authorizations and product launches may be achieved; |
|
|
|
changes in the FDAs position on the safety or effectiveness of our products; |
|
|
|
changes in our product mix; |
|
|
|
the anticipated size of the markets and demand for our products; |
|
|
|
changes in prescription levels; |
|
|
|
the impact of acquisitions, divestitures and other significant corporate transactions,
including the disposition of LipoSonix; |
|
|
|
the effect of economic changes generally and in hurricane-affected areas; |
|
|
|
manufacturing or supply interruptions; |
|
|
|
importation of other dermal filler or botulinum toxin products, including the unauthorized
distribution of products approved in countries neighboring the U.S.; |
|
|
|
changes in the prescribing or procedural practices of dermatologists and/or plastic
surgeons, including prescription levels; |
|
|
|
the ability to successfully market both new products and existing products; |
|
|
|
difficulties or delays in manufacturing and packaging of our products, including
delays and quality control lapses of third party manufacturers and suppliers of our
products; |
|
|
|
the availability of product supply or changes in the cost of raw materials; |
|
|
|
trends toward managed care and health care cost containment, including health care
initiatives and other third-party cost-containment pressures that could impose financial
burdens or cause us to sell our products at lower prices, resulting in decreased
revenues; |
|
|
|
inadequate protection of our intellectual property or challenges to the validity or
enforceability of our proprietary rights and our ability to secure patent protection from
filed patent applications for our primary products, including SOLODYN®; |
|
|
|
possible introduction of generic versions of our products, including SOLODYN®; |
|
|
|
possible federal and/or state legislation or regulatory action affecting, among other
things, the Companys ability to enter into agreements with companies introducing generic
versions of the Companys products as well as pharmaceutical pricing, federal pharmaceutical
contracts, mandatory discounts, and reimbursement, including under 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 Note 17 in our accompanying condensed
consolidated financial statements and Part II, Item 1, Legal Proceedings); |
|
|
|
changes in U.S. generally accepted accounting principles; |
|
|
|
additional costs related to compliance with changing regulation of corporate
governance and public financial disclosure; |
|
|
|
any changes in business, political and economic conditions due to the threat of future
terrorist activity in the U.S. and other parts of the world; |
|
|
|
access to available and feasible financing on a timely basis; |
|
|
|
the availability of product acquisition or in-licensing opportunities; |
|
|
|
the risks and uncertainties normally incident to the pharmaceutical and medical device
industries, including product liability claims; |
|
|
|
the risks and uncertainties associated with obtaining necessary FDA approvals; |
|
|
|
the inability to obtain required regulatory approvals for any of our pipeline products; |
|
|
|
unexpected costs and expenses, or our ability to limit costs and expenses as our business
continues to grow; |
|
|
|
decreases in revenues associated with the Companys early 2011 discontinuation of
TRIAZ® and decision to no longer promote PLEXION®; |
|
|
|
downturns in general economic conditions that negatively affect our dermal restorative and
branded prescription products, and our ability to accurately forecast our financial
performance as a result; |
|
|
|
changes in our stock price, economic or other market
conditions or corporate or regulatory requirements affecting our
ability to consummate repurchases under our Stock Repurchase Plan; |
|
|
|
failure to comply with our corporate integrity agreement, which could result in substantial
civil or criminal penalties and our being excluded from government health care programs, which
could materially reduce our sales and adversely affect our financial condition and results of
operations; and |
|
|
|
the inability to successfully integrate newly-acquired entities. |
48
We undertake no obligation to publicly update forward-looking statements, whether as a result
of new information, future events or otherwise. You are advised, however, to review any future
disclosures contained in the reports that we file with the SEC. Our Annual Report on Form 10-K for
the year ended December 31, 2010, and this Quarterly Report contain discussions of various risks
relating to our business that could cause actual results to differ materially from expected and
historical results, which you should review. You should understand that it is not possible to
predict or identify all such risks. Consequently, you should not consider any such list or
discussion to be a complete set of all potential risks or uncertainties.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
As of June 30, 2011, there were no material changes to the information previously reported
under Item 7A in our Annual Report on Form 10-K for the year ended December 31, 2010.
Item 4. Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of
the Exchange Act) that are designed to ensure that information required to be disclosed in reports
filed by us under the Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms and that such information is accumulated and
communicated to management, including our Chief Executive Officer and Chief Financial Officer, as
appropriate, to allow for timely decisions regarding required disclosure. Our Chief Executive
Officer and Chief Financial Officer, with the participation of other members of management,
evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2011, and have
concluded that, as of such date, our disclosure controls and procedures were effective to ensure
that the information we are required to disclose in reports that we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the SECs rules and forms.
Although the management of the Company, including the Chief Executive Officer and the Chief
Financial Officer, believes that our disclosure controls and internal controls currently provide
reasonable assurance that our desired control objectives have been met, management does not expect
that our disclosure controls or internal controls will prevent all errors and all fraud. A control
system, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent limitations in all control systems,
no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the Company have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty, and that breakdowns can occur because of
simple error or mistake. Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the controls. The design
of any system of controls is also based in part upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions.
During the three months ended June 30, 2011, 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.
49
Part II. Other Information
Item 1. Legal Proceedings
Lupin SOLODYN® Litigation
On October 8, 2009, we received a Paragraph IV Patent Certification from Lupin Ltd. (Lupin)
advising that Lupin had filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and
Drug Administration (FDA) for generic versions of SOLODYN® in 45mg, 90mg, and 135mg
strengths. Lupin did not advise us as to the timing or status of the FDAs review of its filing,
or whether it has complied with FDA requirements for proving bioequivalence. Lupins Paragraph IV
Patent Certification alleges that our U.S. Patent No. 5,908,838 (the 838 Patent) is invalid.
Lupins Paragraph IV Patent Certification also alleges that our U.S. Patent Nos. 7,541,347, (the
"'347 Patent) and 7,544,373 (the 373 Patent) are not infringed by Lupins manufacture,
importation, use, sale and/or offer for sale of the products for which its ANDA was submitted. On
November 17, 2009, we filed suit against Lupin in the United States District Court for the District
of Maryland seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent
by submitting to the FDA its ANDA for generic versions of SOLODYN® in 45mg, 90mg and
135mg strengths. The relief we requested includes a request for a permanent injunction preventing
Lupin from infringing the 838 Patent by selling generic versions of SOLODYN®. As a
result of the filing of the suit, we believe that the ANDA cannot be approved by the FDA until
after the expiration of a 30-month stay period or a court decision that the patent is invalid or
not infringed.
On November 24, 2009, we received a Paragraph IV Patent Certification from Lupin, advising
that Lupin had filed a supplement or amendment to its earlier filed ANDA assigned ANDA number
91-424 with the FDA for a generic version of SOLODYN® in 65mg strength. Lupin has not
advised us as to the timing or status of the FDAs review of its filing, or whether Lupin has
complied with FDA requirements for proving bioequivalence. Lupins Paragraph IV Patent
Certification alleges that our 838 Patent is invalid. Lupins submission amends an ANDA already
subject to a 30-month stay. As such, we believe that the supplement or amendment cannot be
approved by the FDA until after the expiration of the 30-month period or a court decision that the
patent is invalid or not infringed.
On December 23, 2009, we received a Paragraph IV Patent Certification from Lupin advising that
Lupin had filed a supplement or amendment to its earlier filed ANDA assigned ANDA number 91-424
with the FDA for a generic version of SOLODYN® in 115mg strength. Lupin has not advised
us as to the timing or status of the FDAs review of its filing, or whether Lupin has complied with
FDA requirements for proving bioequivalence. Lupins Paragraph IV Patent Certification alleges that
the 838 Patent is invalid. Lupins Paragraph IV Patent Certification also alleges that the 347
Patent and 373 Patent are not infringed by Lupins manufacture, importation, use, sale and/or
offer for sale of the products for which the supplement or amendment was submitted. Lupins
submission amends an ANDA already subject to a 30-month stay. As such, we believe that the
supplement or amendment cannot be approved by the FDA until after the expiration of the 30-month
period or a court decision that the patent is invalid or not infringed. On December 28, 2009, we
amended our complaint against Lupin seeking an adjudication that Lupin has infringed one or more
claims of the 838 Patent by submitting its supplement or amendment to its ANDA for a generic
version of SOLODYN® in 65mg strength. On February 2, 2010, we amended our complaint
against Lupin seeking an adjudication that Lupin has infringed one or more claims of the 838
Patent by submitting its supplement or amendment to its earlier filed ANDA for a generic version of
SOLODYN® in 115mg strength.
On July 1, 2010, we amended our complaint against Lupin in the United States District Court
for the District of Maryland relating to Lupins filing of its ANDA, and amendments or supplements
thereto, for generic versions of SOLODYN® in 45mg, 65mg, 90mg, 115mg and 135mg
strengths. We amended the complaint to assert new claims 19, 21, 23, 25 and 27-34 of the 838
Patent included in an Ex Parte Reexamination Certificate we received from the USPTO on June 1, 2010
in connection with a reexamination of the 838 Patent by the USPTO a the request of a third party.
The complaint seeks an adjudication that Lupin has infringed one or more claims of the 838 Patent,
including the new claims, by submitting the ANDA, and amendments or supplements thereto, to the
FDA.
On September 17, 2010, we received an additional Paragraph IV Patent Certification from Lupin
advising that Lupin had filed a supplement or amendment to its earlier filed ANDA assigned ANDA
number 91-424 with the FDA for generic versions of SOLODYN® in 45mg, 65mg, 90mg, 115mg
and 135mg strengths. Lupins Paragraph IV Patent Certification alleges that our U.S. Patent No.
7,790,705 (the 705 Patent), which was issued to us by the
50
U.S. Patent and Trademark Office (USPTO) on September 7, 2010, will not be infringed by
Lupins manufacture, use, sale and/or importation of the products for which the supplement or
amendment was submitted. Lupins submission amends an ANDA already subject to a 30-month stay. As
such, we believe that the supplement or amendment cannot be approved by the FDA until after the
expiration of the 30-month period or a court decision that the patent is invalid or not infringed.
On October 18, 2010, we amended our complaint against Lupin in the United States District
Court for the District of Maryland relating to Lupins filing of its ANDA, and amendments or
supplements thereto for generic versions of SOLODYN® in 45mg, 65mg, 90mg, 115mg and
135mg strengths. We amended the complaint to allege that Lupin has infringed one or more claims of
the 705 Patent by submitting its ANDA, and amendments or supplements thereto, to the FDA to obtain
approval for the commercial manufacture, use, offer for sale, sale, or distribution in and/or
importation into the United States of its generic versions of SOLODYN® before the
expiration of the 705 Patent.
On December 3, 2010, we received a Paragraph IV Patent Certification from Lupin advising that
Lupin had filed a supplement or amendment to its earlier filed ANDA assigned ANDA number 91-424
with the FDA for generic versions of SOLODYN® in 55mg and 80mg strengths. Lupin has not
advised us as to the timing or status of the FDAs review of its filing, or whether Lupin has
complied with FDA requirements for proving bioequivalence. Lupins Paragraph IV Patent
Certification alleges that the 838 Patent is invalid. Lupins Paragraph IV Patent Certification
also alleges that the 705 Patent will not be infringed by Lupins manufacture, use, sale and/or
importation of the products for which the supplement or amendment was submitted. Lupins
submission amends an ANDA already subject to a 30-month stay. As such, we believe that the
supplement or amendment cannot be approved by the FDA until after the expiration of the 30-month
period or a court decision that the patents are invalid or not infringed. On January 10, 2011, we
amended our complaint against Lupin seeking an adjudication that Lupin has infringed one or more
claims of the 838 Patent and the 705 Patent by filing the supplement or amendment to its earlier
filed ANDA assigned ANDA number 91-424 for generic versions of SOLODYN® in 55mg and 80mg
strengths.
On January 24, 2011, we received a Paragraph IV Patent Certification from Lupin advising that
Lupin had filed a supplement or amendment to its earlier filed ANDA assigned ANDA number 91-424
with the FDA for a generic version of SOLODYN® in 105mg strength. Lupin has not advised
us as to the timing or status of the FDAs review of its filing, or whether Lupin has complied with
FDA requirements for proving bioequivalence. Lupins Paragraph IV Patent Certification alleges that
the 838 Patent is invalid. Lupins Paragraph IV Patent Certification also alleges that the 705
Patent will not be infringed by Lupins manufacture, use, sale and/or importation of the products
for which the supplement or amendment was submitted. Lupins submission amends an ANDA already
subject to a 30-month stay. As such, we believe that the supplement or amendment cannot be
approved by the FDA until after the expiration of the 30-month period or a court decision that the
patents are invalid or not infringed. On March 2, 2011, we amended our complaint against Lupin
seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent and the 705
Patent by filing the supplement or amendment to its earlier filed ANDA assigned ANDA number 91-424
for generic versions of SOLODYN® in 105mg strength.
On February 2, 2011, the Maryland Court issued an Order staying the litigation through and
including April 1, 2011, to permit us and Lupin to discuss settlement of the litigation. On March
24, 2011, we and Lupin jointly requested that the Court extend the stay for an additional period
through and including May 16, 2011, which was subsequently approved by the Court. On
June 20, 2011, the Court issued a further Order staying the litigation through and including July
18, 2011.
On April 19, 2011, we received a Paragraph IV Patent Certification from Lupin advising that
Lupin had filed a supplement or amendment to its earlier filed ANDA assigned ANDA number 91-424
with the FDA for generic versions of SOLODYN® in 45mg, 55mg, 65mg, 80mg, 90mg, 105mg,
115mg and 135 mg strengths. Lupin has not advised us as to the timing or status of the FDAs
review of its filing, or whether Lupin has complied with FDA requirements for proving
bioequivalence. Lupins Paragraph IV Patent Certification alleges that our newly issued U.S.
Patent No. 7,919,483 (the 483 Patent), which was issued to us by the USPTO on April 5, 2011,
will not be infringed by Lupins manufacture, use, sale and/or importation of the products for
which the supplement or amendment was submitted. The expiration date for the 483 Patent is in
February 2027. We are evaluating the details of Lupins certification letter and considering our
options. Lupins submission amends an ANDA already subject to a 30-month stay. As such, we
believe that the amendment cannot be approved by the FDA until after the expiration of the 30-month
period or a court decision that the patent is invalid or not infringed.
51
On July 21, 2011, we entered into a License and Settlement Agreement (the Lupin Settlement
Agreement) with Lupin and Lupin Pharmaceuticals, Inc. (together referred to as Lupin hereunder).
Under the terms of the Lupin Settlement Agreement, we agreed to grant to Lupin a future license to
make and sell its generic versions of SOLODYN® in 45mg, 90mg, and 135mg strengths under
the SOLODYN® intellectual property rights belonging to us, with the license grant
effective November 26, 2011, or earlier under certain conditions. We also agreed to grant to Lupin
future licenses to make and sell its generic versions of SOLODYN® in 65mg and 115mg
strengths effective in February 2018, or earlier under certain conditions, and its generic versions
of SOLODYN® in 55mg (against which Lupins Paragraph IV Patent Certification was the
first received by us), 80mg and 105mg strengths effective in February 2019, or earlier under
certain conditions. The Lupin Settlement Agreement provides that Lupin will be required to pay us
royalties based on sales of Lupins generic SOLODYN® products pursuant to the foregoing
licenses. Pursuant to the Lupin Settlement Agreement, the companies agreed to terminate all legal
disputes between them relating to SOLODYN®. In addition, Lupin confirmed that our
patents relating to SOLODYN® are valid and enforceable, and cover Lupins activities
relating to Lupins generic SOLODYN® products under its ANDA. Lupin also agreed to be
permanently enjoined from any distribution of generic SOLODYN® products in the U.S.
except as described above.
Aurobindo SOLODYN® Litigation
On October 26, 2010, we received a Paragraph IV Patent Certification from Aurobindo Pharma
Limited (Aurobindo Pharma) advising that Aurobindo Pharma had filed an ANDA with the FDA for
generic versions of SOLODYN® in 45mg, 65mg, 90mg, 115mg and 135mg strengths. Aurobindo
Pharma has not advised us as to the timing or status of the FDAs review of its filing, or whether
it has complied with FDA requirements for proving bioequivalence. Aurobindo Pharmas Paragraph IV
Patent Certification alleges that the 838 Patent is invalid. Aurobindo Pharmas Paragraph IV
Patent Certification also alleges that the 347 Patent, 373 Patent and 705 Patent are not
infringed by Aurobindo Pharmas manufacture, importation, use, sale and/or offer for sale of the
products for which the ANDA was submitted.
On December 3, 2010, we filed suit against Aurobindo Pharma and Aurobindo Pharma USA, Inc.
(together, Aurobindo) in the United States District Court for the District of Delaware. On
December 6, 2010, we also filed suit against Aurobindo in the United States District Court for the
District of New Jersey. The suits seek an adjudication that Aurobindo has infringed one or more
claims of the 838 Patent and the 705 Patent by submitting to the FDA an ANDA for generic versions
of SOLODYN® in 45mg, 65mg, 90mg, 115mg and 135mg strengths. The relief we requested
includes a request for a permanent injunction preventing Aurobindo from infringing the asserted
claims of the 838 Patent and the 705 Patent by engaging in the manufacture, use, importation,
offer to sell, sale or distribution of generic versions of SOLODYN® before the
expiration of the patents.
On June 1, 2011, we received a Paragraph IV Patent Certification from Aurobindo advising that
Aurobindo had filed a supplement or amendment to its earlier filed ANDA with the FDA for generic
versions of SOLODYN® in 45mg, 65mg, 90mg, 115mg and 135mg strengths.
Aurobindo has not advised us as to the timing or status of the FDAs review of its filing, or
whether Aurobindo has complied with FDA requirements for proving bioequivalence. Aurobindos
Paragraph IV Patent Certification alleges that our newly issued U.S. Patent No. 7,919,483 (the
"'483 Patent), which was issued to us by the USPTO on April 15, 2011, will not be infringed by
Aurobindos manufacture, use, sale and/or importation of the products for which the supplement or
amendment was submitted. The expiration date for the 483 Patent is in February 2027. We are
evaluating the details of Aurobindos certification letter and considering our options.
Aurobindos submission amends an ANDA already subject to a 30-month stay. As such, we believe that
the amendment cannot be approved by the FDA until after the expiration of the 30-month period or a
court decision that the patent is invalid or not infringed.
Nycomed VANOS® Litigation
On April 7, 2010, we received a Paragraph IV Patent Certification from Nycomed US Inc.
advising that Nycomed US Inc. had filed an ANDA with the FDA for a generic version of
VANOS®. Nycomed US Inc. has not advised us as to the timing or status of the FDAs
review of its filing, or whether it has complied with FDA requirements for proving bioequivalence.
Nycomed US Inc.s Paragraph IV Patent Certification alleges that our U.S. Patent Nos. 6,765,001
(the 001 Patent) and 7,220,424 (the 424 Patent) will not be infringed by Nycomed US Inc.s
manufacture, use, sale, offer for sale or importation of the product for which the ANDA was
submitted.
52
On May 19, 2010, we filed suit against Nycomed US Inc. and Nycomed GmbH (together, hereunder
Nycomed) in the United States District Court for the Southern District of New York and the United
States District Court for the District of Delaware seeking an adjudication that Nycomed has
infringed one or more claims of our 001 Patent, 424 Patent and U.S. Patent No. 7,217,422 (the
"'422 Patent) by submitting the ANDA to the FDA. The relief we requested includes a request for a
permanent injunction preventing Nycomed from infringing the patents by selling a generic version of
VANOS® prior to the expiration of the asserted patents. On August 3, 2010, Nycomed
responded in the New York action by filing an answer, affirmative defenses, and counterclaims
alleging that the patents-in-suit are invalid, unenforceable, and will not be infringed by
Nycomeds proposed generic version of VANOS®, and a motion to dismiss certain claims
related to the patents-in-suit. On August 3, 2010, Nycomed responded in the Delaware action by
filing a motion to transfer the Delaware action to New York and a motion to dismiss certain claims
related to the patents-in-suit. We responded to Nycomeds motions and pleadings on December 15,
2010.
On December 23, 2010, Nycomed filed an amended answer and counterclaims in the New York action
alleging only invalidity and noninfringement of the patents-in-suit. On January 14, 2011, we filed
an answer to Nycomeds amended counterclaims in the New York action denying that any of the
asserted patents are invalid or not infringed. On January 19, 2011 and January 24, 2011, the New
York court endorsed the parties stipulations withdrawing all pending motions.
On January 19, 2011, the Delaware court endorsed the parties stipulation withdrawing
Nycomeds pending motion to dismiss and ordering Nycomed to answer or otherwise respond to the
complaint. On February 2, 2011, Nycomed filed an answer with affirmative defenses alleging that
the patents are invalid, unenforceable, and will not be infringed by Nycomeds proposed generic
version of VANOS®. On March 31, 2011, the Delaware Court granted Nycomeds motion to
transfer the Delaware action to New York. On May 23, 2011, the New York Court
consolidated the Delaware action with the New York action and entered a scheduling order. Pursuant
to the Courts schedule, discovery is set to close on May 4, 2012, and the parties are scheduled to
submit a proposed Pretrial Order on June 1, 2012.
On December 15, 2010, we filed a new complaint for patent infringement against Nycomed US Inc.
in the United States District Court for the District of Delaware. Our new complaint seeks an
adjudication that Nycomed USs filing of its ANDA for fluocinonide cream 0.1% infringes one or more
claims of our U.S. Patent No. 7,794,738 (the 738 Patent). On February 15, 2011, Nycomed
responded by filing a motion to transfer the new Delaware action to New York, as well as a motion
to dismiss for failure to state a claim and lack of subject matter jurisdiction. Medicis opposed
both motions on March 4, 2011, and Nycomed replied on April 12, 2011. On June 16, 2011, the
Delaware Court granted Nycomeds motion to transfer the case to New York. On July 19, 2011, Nycomed
withdrew its motion to dismiss. On July 27, 2011, the New York Court consolidated this action with
the other New York actions. Nycomed is scheduled to answer the complaint on August 12, 2011.
Stiefel VELTIN Litigation
On July 28, 2010, we filed suit against Stiefel Laboratories, Inc., a subsidiary of
GlaxoSmithKline plc (Stiefel), in the United States District Court for the Western District of
Texas San Antonio Division seeking a declaratory judgment that the manufacture and sale of
Stiefels acne product VELTIN Gel, which was approved by the FDA in 2010, will infringe one or
more claims of our U.S. Patent No. RE41,134 (the 134 Patent) covering our product
ZIANA® Gel, a prescription topical gel indicated for the treatment of acne that was
approved by the FDA in November 2006. The 134 Patent is listed in the FDAs Approved Drug
Products with Therapeutic Equivalence Evaluations (Orange Book) and expires in February 2015. We
have rights to the 134 Patent pursuant to an exclusive license agreement with the owner of the
patent. The relief we requested in the lawsuit includes a request for a permanent injunction
preventing Stiefel from infringing the 134 Patent by engaging in the commercial manufacture, use,
importation, offer to sell, or sale of any therapeutic composition or method of use covered by the
134 Patent, including such activities relating to VELTIN, and from inducing or contributing to
any such activities. On October 8, 2010, we and the owner of the 134 Patent filed a motion for a
Preliminary Injunction seeking to enjoin sales of VELTIN. The motion for Preliminary Injunction
remains pending.
Actavis ZIANA® Litigation
On March 30, 2011, we received a Paragraph IV Patent Certification from Actavis Mid Atlantic
LLC (Actavis) advising that Actavis has filed an ANDA with the FDA for a generic version of
ZIANA® (clindamycin
53
phosphate 1.2% and tretinoin 0.025%) Gel. Actavis has not advised us as to the timing or
status of the FDAs review of its filing, or whether Actavis has complied with FDA requirements for
proving bioequivalence. Actavis Paragraph IV Patent Certification alleges that our U.S. Patent
Nos. RE41,134 (the 134 Patent) and 6,387,383 (the 383 Patent) will not be infringed by
Actavis manufacture, use and/or sale of the product for which the ANDA was submitted. The
expiration date for the 134 Patent is in 2015, and the expiration date for the 383 Patent is in
2020. On May 11, 2011, we filed suit against Actavis in the United States District Court for the
District of Delaware. The suit seeks an adjudication that Actavis has infringed one or more clams
of the 134 Patent and the 383 Patent by submitting its ANDA to the FDA. The relief we requested
includes a request for a permanent injunction preventing Actavis from infringing the asserted
claims of the 134 Patent and the 383 Patent by engaging in the commercial manufacture, use, offer
to sell, or sale within the U.S., or importation into the U.S., of any chemical entity, therapeutic
composition, or method of use claimed by the 134 Patent and the 383 Patent, and from inducing or
contributing to such activities, prior to the expiration of the patents-in-suit. As a result of
the filing of the suit, we believe that the ANDA cannot be approved by the FDA until after the
expiration of the 30-month stay period or a court decision that the patents-in-suit are invalid or
not infringed.
Acella TRIAZ® Litigation
On August 19, 2010, we filed suit against Acella Pharmaceuticals, Inc. (Acella) in the
United States District Court for the District of Arizona based on Acellas manufacture and offer
for sale of benzoyl peroxide foaming cloths which we believe infringe one or more claims of our
U.S. Patent No. 7,776,355 (the 355 Patent) covering certain of our products, including
TRIAZ® (benzoyl peroxide) 3%, 6% and 9% Foaming Cloths indicated for the topical
treatment of acne vulgaris. The 355 Patent was issued to us by the USPTO on August 17, 2010 and
expires in June 2026. The relief we requested in the lawsuit includes a request for a Permanent
Injunction preventing Acella from infringing the 355 Patent by engaging in the manufacture, use,
importation, offer to sell, or sale of any products covered by the 355 Patent, including Acellas
benzoyl peroxide foaming cloths, and from inducing or contributing to any such activities. Acella
filed with the USPTO a request for ex parte reexamination of the 355 Patent, and filed with the
Court a request that the litigation be stayed for the duration of the reexamination. Both the
request for reexamination and the request for a stay were initially denied. Acella resubmitted its
request for reexamination to the USPTO, which was granted on December 15, 2010. Acella again
requested that the case be stayed pending reexamination, and the Court again denied Acellas
request. We filed a motion for a Preliminary Injunction on December 10, 2010. The hearing on the
Preliminary Injunction motion was to be combined with a Markman Hearing that was also scheduled
for February 23, 2011. At a Markman Hearing, a court determines the scope of the patents claims.
The Court held only the Markman Hearing on February 23, 2011, and deferred the hearing on the
Preliminary Injunction motion until March 29, 2011. At the Markman Hearing, the Court determined
the scope of the patents claims. Due to the need to postpone the March 29, 2011 hearing on the
Preliminary Injunction due to scheduled conflicts, we withdrew our motion for a Preliminary
Injunction in favor of a motion for an expedited trial. The case is now set for trial in January
2012.
LOPROX® Patent Litigation
On July 19, 2011, we filed lawsuits against each of Perrigo Company, Inc. (Perrigo), Nycomed
U.S., Inc. (hereunder Nycomed), and Taro Pharmaceuticals U.S.A., Inc. and Taro Pharmaceutical
Industries, Ltd. (together, Taro, and collectively with Perrigo and Nycomed, the Defendants) in
the United States District Court for the Southern District of New York. Each of the lawsuits seeks
an adjudication that the respective Defendant is infringing one or more claims of our U.S. Patent
No. 7,981,909 (the 909 Patent) by making, using, offering for sale, selling in the U.S. or
importing, without authority, a generic version of LOPROX® Shampoo (ciclopirox) 1%.
Perrigo, Nycomed and Taro received FDA approval for generic ciclopirox 1% shampoos on or about
February 16, 2010, May 25, 2010 and February 23, 2011, respectively. The relief we requested in
each of the lawsuits includes damages and a request for a permanent injunction preventing the
respective Defendant from selling a generic version of LOPROX® prior to the expiration
of the 909 Patent. We have not yet effected formal service of the complaints.
The information set forth under Legal Matters in Note 17 in the notes to the condensed
consolidated financial statements, included in Part I, Item I of this Report, is incorporated
herein by reference. The pending proceedings described in this section and in Legal Matters in
Note 17 in the notes to the condensed consolidated financial statements included in Part I, Item I
of this Report involve complex questions of fact and law and will require the expenditure of
significant funds and the diversion of other resources to prosecute and defend. The results of
legal proceedings are inherently uncertain, and material adverse outcomes are possible. The
resolution of
54
intellectual property litigation may require us to pay damages for past infringement or to obtain a
license under the other partys intellectual property rights that could require one-time license
fees or ongoing royalties, which could adversely impact our product gross margins in future
periods, or could prevent us from manufacturing or selling some of our products or limit or
restrict the type of work that employees involved in such litigation may perform for us. From time
to time we may enter into confidential discussions regarding the potential settlement of pending
litigation or other proceedings; however, there can be no assurance that any such discussions will
occur or will result in a settlement. The settlement of any pending litigation or other proceeding
could require us to incur substantial settlement payments and costs. In addition, the settlement
of any intellectual property proceeding may require us to grant a license to certain of our
intellectual property rights to the other party under a cross-license agreement. If any of those
events were to occur, our business, financial condition and results of operations could be
materially and adversely affected.
Item 1A. Risk Factors
We operate in a rapidly changing environment that involves a number of risks that could
materially and adversely affect our business, financial condition, prospects, operating results or
cash flows. For a detailed discussion of the risk factors that should be understood by any
investor contemplating investment in our stock, please refer to Part I, Item 1A Risk Factors in
our Annual Report on Form 10-K for the year ended December 31, 2010.
There are no material changes from the risk factors previously disclosed in Part I, Item 1A
Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2010.
55
Item 6. Exhibits
|
|
|
Exhibit 10.1+
|
|
Medicis Pharmaceutical Corporation Supplemental Executive Retirement Plan |
|
|
|
Exhibit 10.2+
|
|
Employment Agreement between the Company and Jonah Shacknai, dated June 24, 2011 |
|
|
|
Exhibit 10.3
|
|
Medicis Pharmaceutical Corporation Amended and Restated 2006 Incentive Award Plan(1) |
|
|
|
Exhibit 10.4+
|
|
Form of Stock Option Agreement for Medicis Pharmaceutical Corporation Amended and Restated 2006 Incentive Award
Plan |
|
|
|
Exhibit 10.5+
|
|
Form of Amendment to Stock Option Award Agreement for Medicis Pharmaceutical Corporation Amended and Restated
2006 Incentive Award Plan |
|
|
|
Exhibit 10.6+
|
|
Amendment No. 1 to the Medicis 1992 Stock Option Plan |
|
|
|
Exhibit 10.7+
|
|
Amendment No. 1 to the Medicis 1995 Stock Option Plan |
|
|
|
Exhibit 10.8+
|
|
Amendment No. 2 to the Medicis 1996 Stock Option Plan |
|
|
|
Exhibit 10.9+
|
|
Amendment No. 3 to the Medicis 1998 Stock Option Plan |
|
|
|
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 |
|
|
|
Exhibit 101++*
|
|
The following financial information from Medicis Pharmaceutical Corporations Quarterly Report on Form 10-Q for
the quarter ended June 30, 2011, formatted in XBRL (Extensible Business Reporting Language) includes: (i) the
Condensed Consolidated Balance Sheets as of June 30, 2011 and December 31, 2010, (ii) the Condensed Consolidated
Statements of Income for each of the three-month and six-month periods ended June 30, 2011 and 2010, (iii) the
Condensed Consolidated Statements of Cash Flows for each of the six-month periods ended June 30, 2011 and 2010,
and (iv) the Notes to the Condensed Consolidated Financial Statements. |
|
|
|
+ |
|
Filed herewith |
|
++ |
|
Furnished herewith |
|
* |
|
Pursuant to applicable securities laws and regulations, we are deemed to have complied with
the reporting obligation relating to the submission of interactive data files in such exhibits
and are not subject to liability under any anti-fraud provisions of the federal securities
laws as long as we have made a good faith attempt to comply with the submission requirements
and promptly amend the interactive data files after becoming aware that the interactive data
files fail to comply with the submission requirements. Users of this data are advised that,
pursuant to Rule 406T, these interactive data files are deemed not filed and otherwise are not
subject to liability. |
|
(1) |
|
Incorporated by reference to Appendix A to the Companys Definitive Proxy Statement for the
2011 Annual Meeting of Stockholders filed with the SEC on April 6, 2011. |
56
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, 2011 |
By: |
/s/ Jonah Shacknai
|
|
|
|
Jonah Shacknai |
|
|
|
Chairman of the Board and
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Date: August 9, 2011 |
By: |
/s/ Richard D. Peterson
|
|
|
|
Richard D. Peterson |
|
|
|
Executive Vice President,
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
|
57