e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2011
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 001-35299
ALKERMES PLC
(Exact name of registrant as specified in its charter)
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Ireland
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98-1007018 |
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.) |
Treasury Building, Lower Grand Canal Street
Dublin 2, Ireland
(Address of principal executive offices)
011-353-1-709-4000
(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 o No þ
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files): Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act:
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer þ
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act): Yes o No þ
The number of shares of the issuers Common Stock, $0.01 par value, outstanding as of November
1, 2011, was 129,585,141 shares.
ALKERMES PLC AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2011
2
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES
PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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September 30, |
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March 31, |
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2011 |
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2011 |
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(In thousands, except share and per |
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share amounts) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
89,237 |
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$ |
38,394 |
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Investments short-term |
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126,327 |
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162,928 |
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Receivables |
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79,644 |
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22,969 |
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Inventory |
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47,118 |
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20,425 |
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Prepaid expenses and other current assets |
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13,382 |
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8,244 |
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Total current assets |
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355,708 |
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252,960 |
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PROPERTY, PLANT AND EQUIPMENT NET |
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304,611 |
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95,020 |
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INTANGIBLE ASSETS NET |
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687,983 |
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GOODWILL |
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104,989 |
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INVESTMENTS LONG-TERM |
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24,990 |
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93,408 |
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OTHER ASSETS |
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25,822 |
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11,060 |
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TOTAL ASSETS |
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$ |
1,504,103 |
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$ |
452,448 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable and accrued expenses |
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$ |
83,750 |
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$ |
44,934 |
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Deferred revenue current |
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4,249 |
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3,123 |
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Long-term debt current |
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2,325 |
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Total current liabilities |
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90,324 |
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48,057 |
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LONG-TERM DEBT |
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441,859 |
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DEFERRED REVENUE LONG-TERM |
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4,359 |
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4,837 |
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DEFERRED TAX LIABILITIES LONG-TERM |
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49,829 |
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OTHER LONG-TERM LIABILITIES |
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8,052 |
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7,536 |
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Total liabilities |
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594,423 |
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60,430 |
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COMMITMENTS AND CONTINGENCIES (Note 15) |
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SHAREHOLDERS EQUITY: |
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Preferred stock, par value, $0.01 per share; 50,000,000 and zero shares authorized;
none issued and outstanding at September 30, 2011 and March 31, 2011,
respectively |
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Common stock, par value, $0.01 per share; 450,000,000 and 160,000,000 shares
authorized; 129,584,585 and 105,771,507 shares issued; 129,584,585 and
95,702,299
shares outstanding at September 30, 2011 and March 31, 2011, respectively |
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1,294 |
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1,055 |
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Non-voting common stock, par value, $0.01 per share; none and 450,000 shares
authorized; none and 382,632 shares issued and outstanding at September 30, 2011
and March 31, 2011, respectively |
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4 |
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Treasury stock, at cost (none and 10,069,208 shares at September 30, 2011 and
March 31, 2011, respectively) |
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(131,095 |
) |
Additional paid-in capital |
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1,358,023 |
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936,295 |
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Accumulated other comprehensive loss |
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(2,916 |
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(3,013 |
) |
Accumulated deficit |
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(446,721 |
) |
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(411,228 |
) |
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Total shareholders equity |
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909,680 |
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392,018 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
1,504,103 |
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$ |
452,448 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
ALKERMES
PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
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Three Months Ended |
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Six Months Ended |
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September 30, |
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September 30, |
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2011 |
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2010 |
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2011 |
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2010 |
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(In thousands, except per share amounts) |
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REVENUES: |
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Manufacturing and royalty revenues |
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$ |
54,039 |
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$ |
42,623 |
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$ |
102,979 |
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$ |
78,431 |
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Product sales, net |
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9,887 |
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6,469 |
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19,573 |
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12,673 |
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Research and development revenue |
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8,052 |
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155 |
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11,309 |
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423 |
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Total revenues |
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71,978 |
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49,247 |
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133,861 |
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91,527 |
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EXPENSES: |
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Cost of goods manufactured and sold |
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17,530 |
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13,911 |
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33,749 |
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26,576 |
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Research and development |
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28,160 |
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23,932 |
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56,210 |
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46,909 |
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Selling, general and administrative |
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36,234 |
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18,436 |
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67,731 |
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38,162 |
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Amortization of acquired intangible assets |
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1,817 |
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1,817 |
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Total expenses |
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83,741 |
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56,279 |
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159,507 |
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111,647 |
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OPERATING LOSS |
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(11,763 |
) |
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(7,032 |
) |
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(25,646 |
) |
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(20,120 |
) |
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OTHER (EXPENSE), NET: |
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Interest income |
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383 |
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673 |
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885 |
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1,525 |
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Interest expense |
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(7,561 |
) |
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(2,168 |
) |
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(7,561 |
) |
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(3,298 |
) |
Other income (expense), net |
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336 |
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(82 |
) |
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425 |
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(183 |
) |
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Total other (expense), net |
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(6,842 |
) |
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(1,577 |
) |
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(6,251 |
) |
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(1,956 |
) |
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LOSS BEFORE INCOME TAXES |
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(18,605 |
) |
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(8,609 |
) |
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(31,897 |
) |
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(22,076 |
) |
INCOME TAX PROVISION (BENEFIT) |
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3,650 |
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(943 |
) |
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3,596 |
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(1,001 |
) |
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NET LOSS |
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$ |
(22,255 |
) |
|
$ |
(7,666 |
) |
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$ |
(35,493 |
) |
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$ |
(21,075 |
) |
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LOSS PER COMMON SHARE: |
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Basic and diluted |
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$ |
(0.22 |
) |
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$ |
(0.08 |
) |
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$ |
(0.36 |
) |
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$ |
(0.22 |
) |
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
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Basic and diluted |
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102,474 |
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95,511 |
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99,578 |
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95,419 |
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COMPREHENSIVE LOSS: |
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Net loss |
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$ |
(22,255 |
) |
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$ |
(7,666 |
) |
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$ |
(35,493 |
) |
|
$ |
(21,075 |
) |
Unrealized (losses) gains on marketable securities: |
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Holding (losses) gains, net of tax |
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(188 |
) |
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453 |
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341 |
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947 |
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|
|
|
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|
|
|
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|
Unrealized (losses) gains on marketable securities |
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|
(188 |
) |
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|
453 |
|
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|
341 |
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|
947 |
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|
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Unrealized
losses on derivative contracts, net of tax |
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(244 |
) |
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(244 |
) |
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COMPREHENSIVE LOSS |
|
$ |
(22,687 |
) |
|
$ |
(7,213 |
) |
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$ |
(35,396 |
) |
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$ |
(20,128 |
) |
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|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
ALKERMES
PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
(unaudited)
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Accumulated |
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Additional |
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Other |
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Common Stock |
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Non-voting Common Stock |
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Paid-In |
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Comprehensive |
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Accumulated |
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Treasury Stock |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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(Loss) Income |
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Deficit |
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Shares |
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Amount |
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Total |
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(In thousands, except share data) |
BALANCE March 31, 2010 |
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104,815,328 |
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|
$ |
1,047 |
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|
382,632 |
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|
$ |
4 |
|
|
$ |
910,326 |
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|
$ |
(3,392 |
) |
|
$ |
(365,688 |
) |
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|
(9,945,265 |
) |
|
$ |
(129,681 |
) |
|
$ |
412,616 |
|
Issuance of common stock under employee stock plans |
|
|
433,436 |
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|
3 |
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|
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|
1,351 |
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|
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|
1,354 |
|
Receipt of Alkermes stock for the purchase of stock options or
to satisfy minimum tax withholding obligations related to
stock based awards |
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|
|
|
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|
|
|
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|
(96,528 |
) |
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|
(1,098 |
) |
|
|
(1,098 |
) |
Share-based compensation expense |
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|
|
|
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|
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|
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|
9,347 |
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|
9,347 |
|
Unrealized gains on marketable securities, net of tax of $559 |
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|
|
|
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|
|
|
|
|
|
|
|
|
|
|
947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
947 |
|
Net loss |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,075 |
) |
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|
|
|
|
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|
(21,075 |
) |
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|
BALANCE September 30, 2010 |
|
|
105,248,764 |
|
|
$ |
1,050 |
|
|
|
382,632 |
|
|
$ |
4 |
|
|
$ |
921,024 |
|
|
$ |
(2,445 |
) |
|
$ |
(386,763 |
) |
|
|
(10,041,793 |
) |
|
$ |
(130,779 |
) |
|
$ |
402,091 |
|
|
|
|
|
|
|
|
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|
BALANCE March 31, 2011 |
|
|
105,771,507 |
|
|
$ |
1,055 |
|
|
|
382,632 |
|
|
$ |
4 |
|
|
$ |
936,295 |
|
|
$ |
(3,013 |
) |
|
$ |
(411,228 |
) |
|
|
(10,069,208 |
) |
|
$ |
(131,095 |
) |
|
$ |
392,018 |
|
Issuance of common stock to Elan Corporation, plc in
connection with the purchase of Elan Drug Technologies, refer to Note 1 The Company |
|
|
31,900,000 |
|
|
|
319 |
|
|
|
|
|
|
|
|
|
|
|
524,755 |
|
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|
|
525,074 |
|
Issuance of common stock under employee stock plans |
|
|
1,770,477 |
|
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
12,203 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,221 |
|
Receipt of Alkermes stock for the purchase of stock options or
to satisfy minimum tax withholding obligations related to
stock based awards |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,105 |
|
|
|
|
|
|
|
|
|
|
|
(170,823 |
) |
|
|
(3,105 |
) |
|
|
|
|
Share-based compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,636 |
|
Excess tax benefit from share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,127 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,127 |
|
Conversion of non-voting common stock to common stock |
|
|
382,632 |
|
|
|
4 |
|
|
|
(382,632 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cancellation of treasury stock |
|
|
(10,240,031 |
) |
|
|
(102 |
) |
|
|
|
|
|
|
|
|
|
|
(134,098 |
) |
|
|
|
|
|
|
|
|
|
|
10,240,031 |
|
|
|
134,200 |
|
|
|
|
|
Unrealized gains on marketable securities, net of tax of $202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
341 |
|
Unrealized loss on cash flow hedge, net of tax of $145 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(244 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,493 |
) |
|
|
|
|
|
|
|
|
|
|
(35,493 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE September 30, 2011 |
|
|
129,584,585 |
|
|
$ |
1,294 |
|
|
|
|
|
|
$ |
|
|
|
$ |
1,358,023 |
|
|
$ |
(2,916 |
) |
|
$ |
(446,721 |
) |
|
|
|
|
|
$ |
|
|
|
$ |
909,680 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
ALKERMES
PLC AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
|
2011 |
|
|
2010 |
|
|
|
(In thousands) |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(35,493 |
) |
|
$ |
(21,075 |
) |
Adjustments to reconcile net loss to cash flows from operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
6,377 |
|
|
|
4,062 |
|
Share-based compensation expense |
|
|
12,712 |
|
|
|
9,404 |
|
Deferred income taxes |
|
|
(9,664 |
) |
|
|
|
|
Other non-cash charges |
|
|
719 |
|
|
|
1,899 |
|
Changes in assets and liabilities, excluding the effect of acquisitions: |
|
|
|
|
|
|
|
|
Receivables |
|
|
733 |
|
|
|
(10,454 |
) |
Inventory, prepaid expenses and other assets |
|
|
(11,921 |
) |
|
|
1,791 |
|
Accounts payable and accrued expenses |
|
|
20,794 |
|
|
|
(7,710 |
) |
Deferred revenue |
|
|
189 |
|
|
|
1,692 |
|
Other long-term liabilities |
|
|
|
|
|
|
(75 |
) |
Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal
attributable to original issue discount |
|
|
|
|
|
|
(6,611 |
) |
|
|
|
|
|
|
|
Cash flows used in operating activities |
|
|
(15,554 |
) |
|
|
(27,077 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase of property, plant and equipment |
|
|
(3,654 |
) |
|
|
(6,719 |
) |
Sales of property, plant and equipment |
|
|
3 |
|
|
|
206 |
|
Acquisition of Elan Drug Technologies, net of cash acquired |
|
|
(494,962 |
) |
|
|
|
|
Investment in Acceleron Pharmaceuticals, Inc. |
|
|
|
|
|
|
(501 |
) |
Purchases of investments |
|
|
(134,801 |
) |
|
|
(240,371 |
) |
Sales and maturities of investments |
|
|
240,363 |
|
|
|
276,437 |
|
|
|
|
|
|
|
|
Cash flows (used in) provided by investing activities |
|
|
(393,051 |
) |
|
|
29,052 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from the issuance of common stock for share-based compensation arrangements |
|
|
12,221 |
|
|
|
1,354 |
|
Excess tax benefit from share-based compensation |
|
|
3,127 |
|
|
|
|
|
Proceeds from the issuance of long-term debt |
|
|
444,100 |
|
|
|
|
|
Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal |
|
|
|
|
|
|
(45,397 |
) |
|
|
|
|
|
|
|
Cash flows provided by (used in) financing activities |
|
|
459,448 |
|
|
|
(44,043 |
) |
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
|
|
50,843 |
|
|
|
(42,068 |
) |
CASH AND CASH EQUIVALENTS Beginning of period |
|
|
38,394 |
|
|
|
79,324 |
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS End of period |
|
$ |
89,237 |
|
|
$ |
37,256 |
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH FLOW DISCLOSURE: |
|
|
|
|
|
|
|
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
Purchased capital expenditures included in accounts payable and accrued expenses |
|
$ |
131 |
|
|
$ |
578 |
|
See Note 3 for supplemental disclosure of non-cash investing activities.
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. THE COMPANY
Alkermes plc (Alkermes or the Company) is a fully integrated, global
biopharmaceutical company that applies its scientific expertise and proprietary
technologies to develop innovative medicines that improve patient outcomes. The Company
has a diversified portfolio of more than 20 commercial drug products and a substantial
clinical pipeline of product candidates that address central nervous system (CNS)
disorders such as addiction, schizophrenia and depression. Headquartered in Dublin,
Ireland, Alkermes has a research and development center and corporate offices in Waltham, Massachusetts and
manufacturing facilities in Athlone, Ireland; Gainesville, Georgia; and Wilmington,
Ohio.
On September 16, 2011, the business of Alkermes, Inc. and the drug technologies
business (EDT) of Elan Corporation, plc (Elan) were combined (referred to as the Business Combination, the acquisition of
EDT or the EDT acquisition) in a transaction accounted for as a reverse acquisition with Alkermes, Inc. treated as the accounting acquirer. As a result, the historical financial statements of Alkermes, Inc. are included in the comparative prior periods. As part of the Business Combination, Antler
Acquisition Corp., a wholly owned subsidiary of the Company, merged with and into
Alkermes, Inc. (the Merger), with Alkermes, Inc. surviving as a wholly owned
subsidiary of the Company. Prior to the Merger, EDT was carved-out of Elan and
reorganized under the Company. At the effective time of the Merger, (i) each share of
Alkermes, Inc. common stock then issued and outstanding and all associated rights were
canceled and automatically converted into the right to receive one ordinary
share of the Company; (ii) all then issued and outstanding options to purchase
Alkermes, Inc. common stock granted under any stock option plan were converted into
options to purchase on substantially the same terms and conditions the same number of
ordinary shares of the Company at the same exercise price; and (iii) all then issued
and outstanding awards of Alkermes Inc. common stock were converted into awards of the same
number, on substantially the same terms and conditions, of ordinary shares of the
Company. As a result, upon consummation of the Merger and the issuance of the ordinary
shares of the Company in exchange for the canceled shares of Alkermes, Inc. common
stock, the former shareholders of Alkermes, Inc. owned approximately 75% of the Company,
with the remaining approximately 25% of the Company owned by a subsidiary of Elan
pursuant to the terms of a shareholders agreement.
Except
where specifically noted or the context otherwise requires, the
use of the terms such as Alkermes and Company and
we and our and us in these
Notes to Condensed Consolidated Financial Statements refers to
Alkermes and Alkermes, Inc., interchangeably.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of Alkermes for the
three and six months ended September 30, 2011 and 2010 are unaudited and have been
prepared on a basis substantially consistent with the audited financial statements for
the year ended March 31, 2011. The year-end condensed consolidated balance sheet data
was derived from audited financial statements, but does not include all disclosures
required by accounting principles generally accepted in the United States of America
(U.S.) (commonly referred to as GAAP). In the opinion of management, the condensed
consolidated financial statements include all adjustments, which are of a normal
recurring nature, that are necessary to present fairly the results of operations for
the reported periods. These financial statements should be read in conjunction with the
financial statements and notes thereto of Alkermes, Inc. which are
contained, or incorporated by reference, in Alkermes, Inc.s Annual Report on Form 10-K
for the year ended March 31, 2011, as amended (the Annual Report), and the audited financial statements and notes thereto, which has been filed with the U.S. Securities and
Exchange Commission (SEC). The
results of the Companys operations for any interim period are not necessarily
indicative of the results of the Companys operations for any other interim period or
for a full fiscal year.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of Alkermes
plc and its wholly-owned subsidiaries: Alkermes Ireland Holdings Limited, Alkermes
Pharma Ireland Limited, Alkermes US Holdings, Inc., Alkermes, Inc., Eagle Holdings USA,
Inc., Alkermes Gainesville LLC, Alkermes Controlled Therapeutics, Inc., and Alkermes
Europe, Ltd. Intercompany accounts and transactions have been eliminated.
Use of Estimates
The preparation of the Companys condensed consolidated financial statements in
accordance with GAAP requires management to make estimates, judgments, and assumptions
that may affect the reported amounts of assets, liabilities, revenues and expenses, and
related disclosure of contingent assets and liabilities. On an on-going basis, the
Company evaluates its estimates and judgments and methodologies, including those
related to revenue recognition and related allowances, its collaborative relationships,
clinical trial expenses, the valuation of inventory, impairment and amortization of
intangibles and long-lived assets, share-based compensation, income taxes including the
valuation allowance for deferred tax assets, valuation of investments and derivative
instruments, litigation, and restructuring charges. The Company bases its
estimates on historical experience and on various other assumptions that are
believed to be reasonable, the results of which form the basis for making judgments
about the carrying values of assets and liabilities. Actual results may differ from
these estimates under different assumptions or conditions.
7
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Risk-management instruments
On
September 16, 2011, the Company entered into a $310.0 million first lien term
loan facility (the First Lien Term Loan)
and a $140.0 million second lien term loan
facility the (Second Lien Term Loan and, together with the First Lien Term Loan,
the Term Loans). Interest on the Term Loans is at a rate equal to an applicable
margin plus three-month LIBOR. The Company addressed its risk to exposure to
fluctuations in interest rates by entering into certain derivative financial
instruments, the objective of which is to limit the impact of fluctuations in interest
rates on earnings. The Companys derivative activities are initiated within the
guidelines of documented corporate risk management policies and do not create
additional risk because gains and losses on derivative contracts offset losses and
gains on the assets, liabilities, and transactions being hedged.
During the three months ended September 30, 2011, the Company entered into an
interest rate swap contract that was designated and qualified as a cash flow hedge. The
Company reviews the effectiveness of its derivatives on a quarterly basis. The
effective portion of gains and losses on the Companys cash flow hedge is reported as a
component of accumulated other comprehensive loss and reclassified into earnings in the
same period the hedged transaction affects earnings. Hedge ineffectiveness is
immediately recognized in earnings.
During the three months ended September 30, 2011, the Company entered into an
interest rate cap contract that was not designated as a hedging instrument. The
interest rate cap is recorded at fair value with associated gains or losses recognized
in current earnings during the period of change.
Segment Information
The Company operates as one business segment, which is the business of developing,
manufacturing and commercializing medicines designed to yield better
therapeutic outcomes and improve the lives of patients with serious diseases. The
Companys chief decision maker, the Chairman and Chief Executive Officer, reviews the
Companys operating results on an aggregate basis and manages the Companys operations
as a single operating unit.
Business Acquisitions
The Companys condensed consolidated financial statements include the operations
of an acquired business after the completion of the acquisition. The Company accounts
for acquired businesses using the acquisition method of accounting. The acquisition
method of accounting for acquired businesses requires, among other things, that most
assets acquired and liabilities assumed be recognized at their estimated fair values as
of the acquisition date, and that the fair value of acquired in-process research and
development (IPR&D) be recorded on the balance sheet. Also, transaction costs are
expensed as incurred. Any excess of the purchase price over the assigned values of the
net assets acquired is recorded as goodwill. Contingent consideration is included
within the acquisition cost and is recognized at its fair value on the acquisition
date. A liability resulting from contingent consideration is remeasured to fair value
at each reporting date until the contingency is resolved. Changes in fair value are
recognized in earnings.
Goodwill and Intangible Assets
Goodwill represents the excess cost of the Companys investment in the net assets
of acquired companies over the fair value of the underlying identifiable net assets at
the date of acquisition. The Companys goodwill balance solely relates to the EDT
acquisition in the fiscal year ended March 31, 2012, as described in Note 3, Acquisitions. Goodwill is not
amortized but is tested for impairment annually or when events or circumstances
indicate the fair value of a reporting unit may be below its carrying value. A
reporting unit is an operating segment or sub-segment to which goodwill is assigned
when initially recorded.
In September 2011, the Financial Accounting Standards Board (FASB) issued
guidance related to testing goodwill for impairment. This accounting standard allows an
entity to first assess qualitative factors to determine whether it is necessary to
perform the current two-step test. If an entity believes, as a result of its
qualitative assessment, that it is more-likely-than-not that the fair value of a
reporting unit is less than its carrying amount, the quantitative impairment test is
required. Otherwise, no further testing is required. An entity can choose to perform
the qualitative assessment on none, some or all of its reporting units. Moreover, an
entity can bypass the qualitative assessment for any reporting unit in any period and
proceed directly to step one of the impairment test, and then resume performing the
qualitative assessment in any subsequent period. This standard is effective for annual
and interim goodwill impairment tests performed for fiscal years beginning after
December 15, 2011. However, an entity can choose to early adopt the standard if its annual test date
is before the issuance of the final standard, provided that the entity has not yet
performed its 2011 annual impairment test or issued its financial statements. The
Company chose to early adopt the provisions of this standard as it had not yet performed its
annual impairment test, which the
Company performs as of October 30, 2011. The adoption of this standard did not
impact the Companys financial position or results of operations.
8
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Companys finite-lived intangible assets consist of core developed technology
and collaboration agreements and are recorded at fair value at the time of their
acquisition and are stated within its condensed consolidated balance sheets net of
accumulated amortization and impairments. The finite-lived intangible assets are
amortized over their estimated useful life using the economic use method, which
reflects the pattern that the economic benefits of the intangible assets are consumed
as revenue is generated from the underlying patent or contract. The useful lives of the
Companys intangible assets are primarily based on the legal or contractual life of the
underlying patent or contract, which does not include additional years for the
potential extension or renewal of the contract or patent. IPR&D represents the fair
value assigned to research and development assets that were acquired prior to its
completion. IPR&D is considered an indefinite-lived asset and is not amortized but is
tested for impairment annually or when events or circumstances indicate the fair value
may be below its carrying value. If and when development is complete, which generally
occurs when regulatory approval to market a product is obtained, the associated assets
would be deemed finite-lived and would then be amortized based on their respective
estimated useful lives at that point in time. The Companys intangible assets were all
acquired as part of the EDT acquisition in the fiscal year ended March 31, 2012, as described in Note 3,
Acquisitions.
Foreign Currency
The Companys functional and reporting currency is the U.S. dollar. Transactions
in foreign currencies are recorded at the exchange rate prevailing on the date of the
transaction. The resulting monetary assets and liabilities are translated into U.S.
dollars at exchange rates prevailing on the subsequent balance sheet date. Gains and
losses as a result of translation adjustments are recorded within Other income
(expense) in the accompanying condensed consolidated statement of operations and
comprehensive loss.
New Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other
standard setting bodies that are adopted by the Company as of the specified effective
date. Unless otherwise discussed, the Company believes that the impact of recently
issued standards that are not yet effective will not have a material impact on its
financial position or results of operations upon adoption.
In January 2010, the Company adopted accounting guidance issued by the FASB
related to fair value measurements that requires additional disclosure related to
transfers in and out of Levels 1 and 2 of the fair value hierarchy. In addition,
effective for the Company on April 1, 2011, this standard further requires an entity to
present disaggregated information about activity in Level 3 fair value measurements on
a gross basis, rather than as one net amount. As this accounting standard only requires
enhanced disclosure, the adoption of this newly issued accounting standard did not
impact the Companys financial position or results of operations.
On April 1, 2011, the Company prospectively adopted the accounting guidance
related to the milestone method of revenue recognition for research and development
arrangements. Under the milestone method, contingent consideration received from the
achievement of a substantive milestone is recognized in its entirety in the period in
which the milestone is achieved, which the Company believes is more consistent with the
substance of its performance under its various licensing and collaboration agreements.
A milestone is defined as an event (i) that can only be achieved based in whole or in
part on either the entitys performance or on the occurrence of a specific outcome
resulting from the entitys performance, (ii) for which there is substantive
uncertainty at the date the arrangement is entered into that the event will be
achieved, and (iii) that would result in additional payments being due to the entity. A
milestone is substantive if the consideration earned from the achievement of the
milestone is consistent with the Companys performance required to achieve the
milestone, or the increase in value to the collaboration resulting from the Companys
performance, relates solely to the Companys past performance, and is reasonable
relative to all of the other deliverables and payments within the arrangement. The
Companys license and collaboration agreements with its partners provide for payments
to the Company upon the achievement of development milestones, such as the completion
of clinical trials or regulatory approval for drug candidates. As of April 1, 2011, the
Companys agreements with partners included potential future payments for development
milestones aggregating $17.0 million from agreements with Amylin Pharmaceuticals, Inc.
(Amylin), and Cilag GmbH International (Cilag).
Given the challenges inherent in developing and obtaining approval for
pharmaceutical and biologic products, there was substantial uncertainty whether any
9
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
such milestones would be achieved at the time these licensing and collaboration
agreements were entered into. In addition, the Company evaluated whether the
development milestones met the remaining criteria to be considered substantive. As a
result of the Companys analysis, the Company considers its development milestones to
be substantive and, accordingly, the Company expects to recognize as revenue future
payments received from such milestones as it achieves each milestone. The election to
adopt the milestone method did not impact the Companys historical financial position
at April 1, 2011. This policy election may result in revenue recognition patterns for
future milestones that are materially different from those recognized for milestones
received prior to adoption. During the six months ended September 30, 2011, the Company
recognized into revenue $3.0 million received from Cilag
upon the achievement of developmental milestones during this period.
During the six months ended September 30, 2011, the Company
recognized a $7.0 million milestone payment it received from Amylin as there were no
remaining performance obligations under this agreement.
Milestone payments received prior to April 1, 2011 from arrangements where the
Company has continuing performance obligations have been deferred and are recognized
through the application of a proportional performance model where the milestone payment
is recognized over the related performance period or, in full, when there are no
remaining performance obligations. The Company makes its best estimate of the period of
time for the performance period. The Company will continue to recognize milestone
payments received prior to April 1, 2011 in this manner. As of September 30, 2011, the
Company has deferred revenue of $5.0 million from milestone payments received prior to
April 1, 2011 that will be recognized ratably through 2018.
In June 2011, the FASB issued guidance related to the presentation of
comprehensive income. This accounting standard (1) eliminates the option to present the
components of other comprehensive income as part of the statement of changes in
stockholders equity; (2) requires the consecutive presentation of the statement of net
income and other comprehensive income; and (3) requires an entity to present
reclassification adjustments on the face of the financial statements from other
comprehensive income to net income. The amendments in this accounting standard 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 nor do the amendments affect
how earnings per share is calculated or presented. This standard is required to be
applied retrospectively and is effective for fiscal years and interim periods within
those years beginning after December 15, 2011. As this accounting standard only
requires enhanced disclosure, the adoption of this standard will not impact the
Companys financial position or results of operations.
3. ACQUISITIONS
On September 16, 2011, the Company acquired EDT from Elan in a transaction
accounted for under the acquisition method of accounting for business
combinations, in
exchange for $500.0 million in cash and 31.9 million
ordinary shares of Alkermes, valued at $525.1
million based on a stock price of $16.46 per share on the acquisition date. Under the
acquisition method of accounting, the assets acquired and liabilities assumed were recorded as of the acquisition date, at their respective fair values. The reported
consolidated financial condition and results of operations after completion of the
acquisition reflect these fair values. EDTs results of operations are included in the
consolidated financial statements from the date of acquisition.
Prior
to the acquisition, EDT, which was a division of Elan, developed and
manufactured pharmaceutical products that deliver clinical benefits to patients using
EDTs experience and proprietary drug technologies in collaboration with other pharmaceutical
companies worldwide. EDTs two principal drug technology platforms are the oral
controlled release platform (OCR) and the bioavailability enhancement platform,
including EDTs NanoCrystal® technology. The Company acquired EDT to
diversify its commercialized
product portfolio and pipeline candidates, enhance its financial resources in
order to invest in its proprietary drug candidates, pursue additional growth
opportunities and reduce its cost of capital.
During the six months ended September 30, 2011, the Company incurred approximately
$22.3 million in expenses related to the EDT acquisition which primarily consist of
banking, legal, accounting and valuation related expenses. These expenses have been
recorded within Selling, general and administrative expense in the accompanying
condensed consolidated statement of operations and comprehensive loss. During the three
and six months ended September 30, 2011, the Companys results of operations included
revenues of $9.1 million and net income of $0.7 million from the acquired EDT business.
The purchase price of the EDT business was as follows (in thousands):
|
|
|
|
|
Upfront payment in accordance with the merger agreement |
|
$ |
500,000 |
|
Equity consideration in accordance with the merger agreement |
|
|
525,074 |
|
|
|
|
|
Total purchase price |
|
$ |
1,025,074 |
|
|
|
|
|
10
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The purchase price allocation resulted in the following amounts being allocated to
the assets acquired and liabilities assumed at the acquisition date based upon their
respective fair values summarized below (in thousands):
|
|
|
|
|
Cash |
|
$ |
5,038 |
|
Receivables |
|
|
57,408 |
|
Inventory |
|
|
29,670 |
|
Prepaid expenses and other current assets |
|
|
2,134 |
|
Property plant and equipment |
|
|
210,800 |
|
Acquired identifiable intangible assets |
|
|
689,800 |
|
Goodwill |
|
|
104,989 |
|
Other assets |
|
|
4,360 |
|
Accounts payable and accrued expenses |
|
|
(19,048 |
) |
Deferred tax liabilities |
|
|
(59,493 |
) |
Other long-term liabilities |
|
|
(584 |
) |
|
|
|
|
Total |
|
$ |
1,025,074 |
|
|
|
|
|
Asset categories acquired in the EDT acquisition included working capital, fixed
assets and identifiable intangible assets, including IPR&D. The allocation of the
purchase price for the acquisition has been prepared on a preliminary basis and changes
to that allocation may occur as additional information becomes available.
The intangible assets acquired include the following (in thousands):
|
|
|
|
|
Collaboration agreements |
|
$ |
500,300 |
|
NanoCrystal technology |
|
|
74,600 |
|
OCR technology |
|
|
66,300 |
|
In-process research and development |
|
|
46,000 |
|
Trademark |
|
|
2,600 |
|
|
|
|
|
Total |
|
$ |
689,800 |
|
|
|
|
|
Intangible assets associated with collaboration agreements relate to the several
collaboration agreements EDT has in place with third-party pharmaceutical companies
related to the development and commercialization of products or an improvement to
existing products based on EDTs experience with drug delivery systems and their
technology platforms. Intangible assets associated with IPR&D relate to various
preclinical EDT product candidates. The estimated fair value for the collaboration
agreements and IPR&D was determined using the excess earnings approach. The excess
earnings approach includes projecting revenue and costs attributable to the associated
collaboration agreement or product candidate and then subtracting the required return
related to other contributory assets used in the business to determine any residual
excess
earnings attributable to the collaboration agreement or product candidate. The
after-tax excess earnings are then discounted to present value using an appropriate
discount rate. The estimated useful life of the collaboration agreements is 12 years.
The NanoCrystal and OCR technologies are platform technologies that are used in
both currently marketed products and potential future products currently under
development. The estimated fair value was determined using the relief from royalty
method, an approach under which fair value is estimated to be the present value of
royalties saved because the Company owns the intangible assets and therefore does not
have to pay a royalty for its use. The estimated useful lives of the NanoCrystal and
OCR technologies are 13 and 12 years, respectively.
The estimated fair value of the EDT trademark was determined using the relief from
royalty method. The Company does not expect to use the EDT trademark beyond March 31,
2012, and as a result, the Company will amortize the full value of the trademark over
the remainder of the fiscal year.
11
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The excess of purchase price over the fair value amounts assigned to the assets
acquired and liabilities assumed represents the goodwill amount resulting from the
acquisition. The Company does not expect any portion of this goodwill to be deductible
for tax purposes. The goodwill attributable to the acquisition of EDT has been recorded
as a noncurrent asset and is not amortized, but is subject to an annual review for
impairment. The factors that contributed to the recognition of goodwill included the
synergies that are specific to the Companys business and not available to market
participants, including the Companys unique ability to leverage its knowledge in the
areas of drug delivery and development of innovative medicines to improve patients
lives, the acquisition of a talented workforce that brings translational medicine
expertise to the Companys preclinical compounds and the Companys ability to utilize
its research capacity to develop additional compounds using the acquired
technologies.
Pro forma financial information (unaudited)
The following unaudited pro forma information presents the combined results of
operations for the three and six months ended September 30, 2011 and 2010 as if the
acquisition of EDT had been completed on April 1, 2010. The unaudited pro forma results
do not reflect any material adjustments, operating efficiencies or potential cost
savings which may result from the consolidation of operations but do reflect certain
adjustments expected to have a continuing impact on the combined results.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands, except per share data) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Revenues |
|
$ |
121,090 |
|
|
$ |
112,359 |
|
|
$ |
244,049 |
|
|
$ |
210,688 |
|
Net loss |
|
$ |
(4,881 |
) |
|
$ |
(10,008 |
) |
|
$ |
(7,817 |
) |
|
$ |
(23,733 |
) |
Basic and diluted
loss per common
share |
|
$ |
(0.04 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.19 |
) |
12
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. INVESTMENTS
|
|
Investments consist of the following: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Unrealized |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses |
|
|
|
|
|
|
Amortized |
|
|
|
|
|
|
Less than |
|
|
Greater than |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
One Year |
|
|
One Year |
|
|
Fair Value |
|
|
|
(In thousands) |
|
September 30, 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
$ |
78,030 |
|
|
$ |
91 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
78,121 |
|
International government agency debt securities |
|
|
31,727 |
|
|
|
115 |
|
|
|
(2 |
) |
|
|
|
|
|
|
31,840 |
|
Corporate debt securities |
|
|
15,119 |
|
|
|
46 |
|
|
|
|
|
|
|
|
|
|
|
15,165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
124,876 |
|
|
|
252 |
|
|
|
(2 |
) |
|
|
|
|
|
|
125,126 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
126,077 |
|
|
|
252 |
|
|
|
(2 |
) |
|
|
|
|
|
|
126,327 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
|
11,000 |
|
|
|
|
|
|
|
(1 |
) |
|
|
|
|
|
|
10,999 |
|
Corporate debt securities |
|
|
8,011 |
|
|
|
|
|
|
|
|
|
|
|
(425 |
) |
|
|
7,586 |
|
Strategic investments |
|
|
644 |
|
|
|
|
|
|
|
(96 |
) |
|
|
|
|
|
|
548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,655 |
|
|
|
|
|
|
|
(97 |
) |
|
|
(425 |
) |
|
|
19,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
5,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,440 |
|
U.S. government obligations |
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
25,512 |
|
|
|
|
|
|
|
(97 |
) |
|
|
(425 |
) |
|
|
24,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
|
$ |
151,589 |
|
|
$ |
252 |
|
|
$ |
(99 |
) |
|
$ |
(425 |
) |
|
$ |
151,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2011 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
$ |
117,298 |
|
|
$ |
129 |
|
|
$ |
(1 |
) |
|
$ |
|
|
|
$ |
117,426 |
|
Corporate debt securities |
|
|
20,973 |
|
|
|
48 |
|
|
|
|
|
|
|
(4 |
) |
|
|
21,017 |
|
International government agency debt securities |
|
|
23,048 |
|
|
|
236 |
|
|
|
|
|
|
|
|
|
|
|
23,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
161,319 |
|
|
|
413 |
|
|
|
(1 |
) |
|
|
(4 |
) |
|
|
161,727 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
162,520 |
|
|
|
413 |
|
|
|
(1 |
) |
|
|
(4 |
) |
|
|
162,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
|
57,709 |
|
|
|
|
|
|
|
(804 |
) |
|
|
|
|
|
|
56,905 |
|
International government agency debt securities |
|
|
15,281 |
|
|
|
|
|
|
|
(93 |
) |
|
|
|
|
|
|
15,188 |
|
Corporate debt securities |
|
|
15,140 |
|
|
|
|
|
|
|
(29 |
) |
|
|
(328 |
) |
|
|
14,783 |
|
Strategic investments |
|
|
644 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
88,774 |
|
|
|
31 |
|
|
|
(926 |
) |
|
|
(328 |
) |
|
|
87,551 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
5,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,440 |
|
U.S. government obligations |
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
94,631 |
|
|
|
31 |
|
|
|
(926 |
) |
|
|
(328 |
) |
|
|
93,408 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
|
$ |
257,151 |
|
|
$ |
444 |
|
|
$ |
(927 |
) |
|
$ |
(332 |
) |
|
$ |
256,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys strategic investments include common stock in public companies with
which the Company has or had a collaborative arrangement.
The proceeds from the sales and maturities of marketable securities, excluding
strategic equity investments, which were primarily reinvested and resulted in realized
gains and losses, were as follows:
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
September 30, |
|
(In thousands) |
|
2011 |
|
|
2010 |
|
Proceeds from the sales and maturities of marketable securities |
|
$ |
240,363 |
|
|
$ |
276,437 |
|
Realized gains |
|
$ |
37 |
|
|
$ |
63 |
|
Realized losses |
|
$ |
11 |
|
|
$ |
20 |
|
13
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Companys available-for-sale and held-to-maturity securities at September 30,
2011 have contractual maturities in the following periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale |
|
|
Held-to-maturity |
|
|
|
Amortized |
|
|
Estimated |
|
|
Amortized |
|
|
Estimated |
|
(In thousands) |
|
Cost |
|
|
Fair Value |
|
|
Cost |
|
|
Fair Value |
|
Within 1 year |
|
$ |
72,733 |
|
|
$ |
72,897 |
|
|
$ |
5,857 |
|
|
$ |
5,857 |
|
After 1 year through 5 years |
|
|
71,154 |
|
|
|
70,814 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
143,887 |
|
|
$ |
143,711 |
|
|
$ |
5,857 |
|
|
$ |
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2011, the Company believes that the unrealized losses on its
available-for-sale investments are temporary. The investments with unrealized losses
consist primarily of corporate debt securities. In making the determination that the
decline in fair value of these securities was temporary, the Company considered various
factors, including but not limited to: the length of time each security was in an
unrealized loss position; the extent to which fair value was less than cost; financial
condition and near term prospects of the issuers; and the Companys intent not to sell
these securities and the assessment that it is more likely than not that the Company
would not be required to sell these securities before the recovery of their amortized
cost basis.
The Company has an $8.5 million investment in a collaborative partner, Acceleron
Pharma, Inc. (Acceleron), which is recorded within Other assets in the accompanying
condensed consolidated balance sheets at September 30, 2011 and March 31, 2011. The
Company accounts for its investment in Acceleron under the cost method as Acceleron is
a privately-held company over which the Company does not exercise significant
influence. The Company will continue to monitor this investment to evaluate whether any
decline in its value has occurred that would be other-than-temporary, based on the
implied value from any recent rounds of financing completed by Acceleron, market prices
of comparable public companies and general market conditions.
The Companys investment in Civitas Therapeutics, Inc. (Civitas) was $0.9
million and $1.3 million at September 30, 2011 and March 31, 2011, respectively, which
is recorded within Other assets in the accompanying condensed consolidated balance
sheets. The Company accounts for its investment in Civitas under the equity method as
the Company has an approximately 11% ownership position in Civitas, has a seat on the
board of directors and believes it may be able to exercise significant influence over
the operating and financial policies of Civitas. During the six months ended September
30, 2011, the Company reduced its investment in Civitas by $0.4 million, which
represented the Companys proportionate share of Civitas net losses for this period.
14
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. FAIR VALUE MEASUREMENTS
The following table presents information about the Companys assets and
liabilities that are measured at fair value on a recurring basis and indicates the fair
value hierarchy of the valuation techniques the Company utilized to determine such fair
value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
2011 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
1,201 |
|
|
$ |
1,201 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
89,120 |
|
|
|
89,120 |
|
|
|
|
|
|
|
|
|
International government agency debt securities |
|
|
31,840 |
|
|
|
31,840 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
22,751 |
|
|
|
|
|
|
|
21,045 |
|
|
|
1,706 |
|
Strategic equity investments |
|
|
548 |
|
|
|
548 |
|
|
|
|
|
|
|
|
|
Interest rate cap contract |
|
|
12 |
|
|
|
|
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
145,472 |
|
|
$ |
122,709 |
|
|
$ |
21,057 |
|
|
$ |
1,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contract |
|
$ |
388 |
|
|
|
|
|
|
|
388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
388 |
|
|
$ |
|
|
|
$ |
388 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2011 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
1,303 |
|
|
$ |
1,303 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
174,331 |
|
|
|
174,331 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
35,801 |
|
|
|
|
|
|
|
34,754 |
|
|
|
1,047 |
|
International government agency debt securities |
|
|
38,471 |
|
|
|
38,471 |
|
|
|
|
|
|
|
|
|
Strategic equity investments |
|
|
675 |
|
|
|
675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
250,581 |
|
|
$ |
214,780 |
|
|
$ |
34,754 |
|
|
$ |
1,047 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no transfers or reclassifications of any securities between Level 1 and
Level 2 during the six months ended September 30, 2011. The following table illustrates
the rollforward of the fair value of the Companys investments whose fair value is
determined using Level 3 inputs:
|
|
|
|
|
|
|
Fair |
|
(In thousands) |
|
Value |
|
Balance, April 1, 2011 |
|
$ |
1,047 |
|
Investments transferred into Level 3 |
|
|
728 |
|
Total unrealized losses included in comprehensive loss |
|
|
(69 |
) |
|
|
|
|
Balance, September 30, 2011 |
|
$ |
1,706 |
|
|
|
|
|
During the six months ended September 30, 2011, there was one investment in
corporate debt securities transferred into Level 3 from Level 2 as trading in this
security ceased during the period.
In September 2011, the Company entered into an interest rate cap and an interest
rate swap agreement, which are described in greater detail in Note 11, Derivative
Instruments. The fair value of the Companys interest rate cap and interest rate swap
agreements were based on an income approach, which excludes accrued interest, and takes into
consideration then-current interest rates and then-current creditworthiness of the Company or the
counterparty, as applicable.
Substantially all of the Companys corporate debt securities have been classified
as Level 2. These securities were initially valued at the transaction price and
subsequently valued, at the end of each reporting period, utilizing market observable
data. The market observable data includes reportable trades, benchmark yields, credit
spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and
economic events. The Company validates the prices developed using the market observable
data by obtaining market values from other pricing sources, analyzing pricing data in
certain instances and confirming that the relevant markets are active.
The
Companys Level 3 investments at September 30, 2011 consist
of two investments in corporate
debt securities. The Company used a discounted cash flow model to determine the
estimated fair value of these securities. The assumptions used in the discounted
15
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
cash
flow model included estimates for interest rates, timing of cash flows, expected
holding periods and risk adjusted discount rates, which include provisions for default
and liquidity risk, which the Company believes to be the most critical assumptions
utilized within the analysis.
The carrying amounts reflected in the condensed consolidated balance sheets for
cash and cash equivalents, accounts receivable, other current assets, accounts payable
and accrued expenses approximate fair value due to their short-term nature. The fair
value of the remaining financial instruments not currently recognized at fair value on
the Companys condensed consolidated balance sheets consist of the Term Loans. The
estimated fair value of the Term Loans, which was based on quoted market price
indications, is as follows:
|
|
|
|
|
|
|
|
|
|
|
Carrying |
|
|
Estimated |
|
(In thousands) |
|
Value |
|
|
Fair Value |
|
First Lien Term Loan |
|
$ |
306,951 |
|
|
$ |
302,250 |
|
Second Lien Term Loan |
|
$ |
137,233 |
|
|
$ |
137,200 |
|
6. INVENTORY
Inventory is stated at the lower of cost or market value. Cost is determined using
the first-in, first-out method. Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In thousands) |
|
2011 |
|
|
2011 |
|
Raw materials |
|
$ |
13,886 |
|
|
$ |
3,100 |
|
Work in process |
|
|
12,131 |
|
|
|
5,843 |
|
Finished goods (1) |
|
|
20,719 |
|
|
|
11,127 |
|
Consigned-out inventory (2) |
|
|
382 |
|
|
|
355 |
|
|
|
|
|
|
|
|
Total inventory |
|
$ |
47,118 |
|
|
$ |
20,425 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
At September 30, 2011 and March 31, 2011, the Company had $1.8 million and $2.0
million, respectively, of finished goods inventory located at its third party
warehouse and shipping service provider. |
|
(2) |
|
At September 30, 2011 and March 31, 2011, consigned-out inventory relates to VIVITROL
inventory in the distribution channel for which the Company has not recognized
revenue. |
7. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In thousands) |
|
2011 |
|
|
2011 |
|
Land |
|
$ |
4,572 |
|
|
$ |
301 |
|
Building and improvements |
|
|
144,606 |
|
|
|
36,792 |
|
Furniture, fixture and equipment |
|
|
168,771 |
|
|
|
62,660 |
|
Leasehold improvements |
|
|
45,179 |
|
|
|
44,779 |
|
Construction in progress |
|
|
37,749 |
|
|
|
42,194 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
400,877 |
|
|
|
186,726 |
|
Less: accumulated depreciation |
|
|
(96,266 |
) |
|
|
(91,706 |
) |
|
|
|
|
|
|
|
Total property, plant and equipment |
|
$ |
304,611 |
|
|
$ |
95,020 |
|
|
|
|
|
|
|
|
16
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. GOODWILL AND INTANGIBLE ASSETS
Intangible assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2011 |
|
|
|
Weighted |
|
|
Gross |
|
|
Accumulated |
|
|
Net |
|
(In thousands) |
|
Amortizable Life |
|
|
Carrying Amount |
|
|
Amortization |
|
|
Carrying Amount |
|
Finite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
|
12 |
|
|
$ |
500,300 |
|
|
$ |
(1,273 |
) |
|
$ |
499,027 |
|
NanoCrystal technology |
|
|
13 |
|
|
|
74,600 |
|
|
|
(131 |
) |
|
|
74,469 |
|
OCR technology |
|
|
12 |
|
|
|
66,300 |
|
|
|
(227 |
) |
|
|
66,073 |
|
Trademark |
|
|
1 |
|
|
|
2,600 |
|
|
|
(186 |
) |
|
|
2,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total finite-lived intangible assets |
|
|
|
|
|
|
643,800 |
|
|
|
(1,817 |
) |
|
|
641,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Indefinite-lived intangible assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IPR&D |
|
|
|
|
|
|
46,000 |
|
|
|
|
|
|
|
46,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
$ |
689,800 |
|
|
$ |
(1,817 |
) |
|
$ |
687,983 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
Company recorded goodwill of $105.0 million in September 2011 in
connection with the acquisition of EDT. There were no changes to the initial carrying
amount of the Companys goodwill during the three months ended September 30, 2011. The
Company recorded $1.8 million of amortization expense related to its intangible assets
during the six months ended September 30, 2011. Based upon the Companys most recent
analysis, amortization of intangible assets included within its consolidated balance
sheet as of September 30, 2011, is expected to be in the range of approximately $42.0
million to $76.0 million annually through fiscal year 2017.
9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In thousands) |
|
2011 |
|
|
2011 |
|
Accounts payable |
|
$ |
15,396 |
|
|
$ |
9,269 |
|
Accrued compensation |
|
|
17,421 |
|
|
|
17,481 |
|
Accrued other |
|
|
50,933 |
|
|
|
18,184 |
|
|
|
|
|
|
|
|
Total accounts payable and accrued expenses |
|
$ |
83,750 |
|
|
$ |
44,934 |
|
|
|
|
|
|
|
|
10. LONG-TERM DEBT
Long-term debt consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In thousands) |
|
2011 |
|
|
2011 |
|
First Lien Term Loan, due September 16, 2017 |
|
$ |
306,951 |
|
|
$ |
|
|
Second Lien Term Loan, due September 16, 2018 |
|
|
137,233 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
444,184 |
|
|
|
|
|
|
|
|
|
|
|
|
Less: current portion |
|
|
(2,325 |
) |
|
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
$ |
441,859 |
|
|
$ |
|
|
|
|
|
|
|
|
|
On September 16, 2011, the Company entered into the Term Loans with certain
of its subsidiaries, as guarantors, Morgan Stanley Senior Funding, Inc., (MSSF) as
administrative agent and as collateral agent, MSSF and
HSBC Securities (USA) Inc., (HSBC) as co-syndication agents, joint lead arrangers and
joint bookrunners, and various other financial institutions, as lenders. The First
Lien Term Loan was issued with an original issue discount of $3.1 million, has a term
of six years and is secured by a first priority lien on substantially all of the
assets and properties of the Company and the guarantors. The Second
Lien Term Loan was issued with an original issue discount of $2.8 million, has a term
of seven years and is secured by a second priority lien on substantially all of the
assets and properties of the Company and the guarantors.
17
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Scheduled maturities with respect to the Term Loans are as follows (in thousands):
|
|
|
|
|
Fiscal Year: |
|
|
|
|
2012 |
|
$ |
775 |
|
2013 |
|
|
3,100 |
|
2014 |
|
|
3,100 |
|
2015 |
|
|
3,100 |
|
2016 |
|
|
3,100 |
|
Thereafter |
|
|
436,825 |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
450,000 |
|
|
|
|
|
The initial applicable margin for borrowings under the First Lien Term Loan will
be three-month LIBOR plus 5.25% with respect to LIBOR borrowings and 4.25% with respect to
base rate borrowings. The initial applicable margin for borrowings under the Second
Lien Term Loan will be three-month LIBOR plus 8.00% with respect to LIBOR borrowings and
7.00% with respect to base rate borrowings. Under each of the Term Loans, LIBOR is subject to
an interest rate floor of 1.50% and the base rate is subject to an interest rate floor
of 2.50%. Commencing with completion of the Companys first fiscal quarter ending after
the Merger, the applicable margin under the First Lien Term Loan is subject to
adjustment each fiscal quarter, based upon meeting a certain consolidated leverage
ratio during the preceding quarter. The applicable margin under the Second Lien Term
Loan is not subject to adjustment.
Required quarterly principal payments of $0.8 million on the First Lien Term Loan
begin on March 31, 2012. The principal amount of the Second Lien Term Loan is due and
payable in full on the maturity date. The Company may make prepayments of principal
without penalty; however, no principal payments may be made on the Second Lien Term
Loan until the First Lien Term Loan has been repaid in full. If prepayments are made
prior to September 16, 2012, the Company may be subject to prepayment premium of 1% of
the amount of the term loans being repaid if the prepayment is made in connection with
a refinancing transaction or 1% of the amount of the outstanding term loans if the
prepayment is made in connection with an amendment to the agreement resulting in a
refinancing transaction.
Each
of the Term Loans has incremental capacity in an amount of
$50.0 million, plus additional amounts so long as Alkermes meets certain conditions,
including a specified leverage ratio. The agreements governing the
Term Loans
include a number of restrictive covenants that, among other things, and subject to
certain exceptions and baskets, impose operating and financial restrictions on
Alkermes, Inc., the Company and the restricted subsidiaries. These financing
agreements also contain customary affirmative covenants and events of default. The
Company was in compliance with its debt covenants at September 30, 2011.
As
part of the Term Loans, the Company is required to enter into and
thereafter maintain hedge agreements to the extent necessary to provide that at least
50% of the aggregate principal amount of the Term Loans is subject to either a fixed
interest rate or interest rate protection for a period of not less than three years.
Pursuant to this term, the Company entered into an interest rate cap and an interest
rate swap agreement, which are discussed in greater detail in Note 11, Derivative
Instruments.
The Company incurred $11.8 million of offering costs associated with the issuance
of the Term Loans which were recorded under the caption Other assets in the
accompanying condensed consolidated balance sheets. The offering costs and original
issue discount related to the Term Loans are being amortized to interest expense over
the estimated repayment terms using the effective interest method. During the six
months ended September 30, 2011, the Company had amortization expense of $0.3 million
related to the offering costs and original issue discount.
11. DERIVATIVE INSTRUMENTS
During the three months ended September 30, 2011, the Company entered into an
interest rate cap agreement with HSBC Bank USA at a cost of less than $0.1 million to
mitigate the impact of fluctuations in the three-month LIBOR rate at
which the
Companys Term Loans bear interest. The interest rate cap agreement became
effective upon the issuance of the Term Loans, expires in December 2012, has a notional
value of $65.0 million and is not designated as a hedging instrument. The Company
recorded an immaterial amount of loss as other expense in the accompanying condensed
consolidated statements of operations and comprehensive loss due to the decline in
value of this contract during the three and six months ended September 30, 2011.
During the three months ended September 30, 2011, the Company entered into an
interest rate swap agreement with Morgan Stanley Capital Services LLC (MSCS) to
mitigate the impact of fluctuations in the three-month LIBOR rate at
which the Companys
Term Loans bear interest. The interest rate swap agreement becomes effective in
December 2012, expires in
18
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
December 2014 and has a notional value of $65.0 million. This
contract has been designated as a cash flow hedge and accordingly, to the extent
effective, any unrealized gains or losses on this interest rate swap contract is
reported in accumulated other comprehensive loss. To the extent the hedge is
ineffective, hedge transaction gains and losses are reported in other income (expense),
net when the interest payment on the related debt is recognized.
The following table summarizes the fair value and presentation in the consolidated
balance sheets for derivatives designated and not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value at |
|
(In thousands) |
|
Balance Sheet Location |
|
|
March 31, 2011 |
|
Interest rate swap |
|
|
|
|
|
|
|
|
Liability derivative designated as a cash flow hedge |
|
Other long-term liabilities |
|
$ |
388 |
|
|
|
|
|
|
|
|
|
|
Interest rate cap |
|
|
|
|
|
|
|
|
Asset derivative not designated as a hedging instrument |
|
Other long-term assets |
|
$ |
11 |
|
The following table summarizes the effect of derivatives designated as hedging
instruments on the condensed consolidated statements of operations and comprehensive
loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount |
|
|
|
|
|
|
Amount |
|
|
Reclassified from |
|
|
|
|
|
|
Recognized in |
|
|
Accumulated Other |
|
|
|
|
|
|
Accumulated Other |
|
|
Comprehensive Loss |
|
|
Amount of |
|
|
|
Comprehensive Loss |
|
|
into Earnings |
|
|
Loss Recorded |
|
(In thousands) |
|
(Effective Portion) |
|
|
(Effective Portion) |
|
|
(Ineffective Portion) |
|
September 30, 2011 |
|
$ |
(245 |
) |
|
$ |
|
|
|
$ |
|
|
The cash flow hedge was deemed to be perfectly effective at September 30,
2011. Accordingly, the Company included the loss incurred during the three and six
months ended September 30, 2011 within accumulated other comprehensive loss. The
Company expects that when this contract matures, any amounts in accumulated other
comprehensive loss is to be reported as an adjustment to interest expense. The Company
considers the impact of its and MSCS credit risk on the fair value of the contract as
well as the ability of each party to execute its obligations under the contract. As of
September 30, 2011, credit risk did not materially change the fair value of the
Companys interest rate swap contract.
12. SHARE-BASED COMPENSATION
Share-based compensation expense consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Cost of goods manufactured and sold |
|
$ |
529 |
|
|
$ |
525 |
|
|
$ |
1,085 |
|
|
$ |
886 |
|
Research and development |
|
|
2,309 |
|
|
|
1,637 |
|
|
|
4,244 |
|
|
|
3,152 |
|
Selling, general and administrative |
|
|
4,214 |
|
|
|
2,786 |
|
|
|
7,383 |
|
|
|
5,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
7,052 |
|
|
$ |
4,948 |
|
|
$ |
12,712 |
|
|
$ |
9,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2011 and March 31, 2011, $0.5 million and $0.6 million,
respectively, of share-based compensation cost was capitalized and recorded as
Inventory in the condensed consolidated balance sheets.
13. LOSS PER SHARE
Basic loss per common share is calculated based upon net loss available to holders
of common shares divided by the weighted average number of shares outstanding. Diluted
loss per common share is based upon the weighted-average number of common shares
outstanding during the period plus additional weighted-average common equivalent shares
outstanding during the period when the effect is dilutive. Common equivalent shares
result from the assumed exercise of outstanding stock options (the proceeds of which
are then assumed to have been used to repurchase outstanding stock using the treasury
stock method) and the vesting of unvested restricted stock units. Common equivalent shares have not been included in the net loss per common share calculations because the
effect would have been anti-dilutive.
19
ALKERMES
PLC AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The potential common equivalent shares consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Stock options |
|
|
8,084 |
|
|
|
13,898 |
|
|
|
8,076 |
|
|
|
13,736 |
|
Restricted stock units |
|
|
1,457 |
|
|
|
909 |
|
|
|
1,555 |
|
|
|
850 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
9,541 |
|
|
|
14,807 |
|
|
|
9,631 |
|
|
|
14,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14. INCOME TAXES
The Company recorded an income tax provision of $3.7 million and $3.6 million for
the three and six months ended September 30, 2011, respectively, and an income tax
benefit of $0.9 million and $1.0 million for the three and six months ended September
30, 2010, respectively. During the three months ended September 30, 2011, the Company
recorded a $13.2 million current tax expense for the taxable transfer of the
BYDUREON® intellectual property from the U.S. to Ireland and a deferred tax
benefit of $9.5 million in connection with the Business Combination, as the Company recorded a
U.S. deferred tax liability in purchase accounting allowing for the partial release of
an existing valuation allowance.
The Company records a deferred tax asset or liability based on the difference
between the financial statement and tax basis of its assets and liabilities, as
measured by enacted jurisdictional tax rates assumed to be in effect when these
differences reverse. At September 30, 2011, the Company determined that it is more
likely than not that its U.S. and Irish deferred tax assets may not be realized and a
full valuation allowance has been recorded.
15. COMMITMENTS AND CONTINGENCIES
The Company and/or the Companys product partners are involved in various
so-called Paragraph IV litigation proceedings in the U.S. In the U.S., putative
generics of innovator drug products (including products in which the innovation
comprises a new drug delivery method for an existing product, such as the drug
delivery market occupied by the Company) may file Abbreviated New Drug
Applications (ANDAs) and, in doing so, they are not required to include
preclinical and clinical data to establish safety and effectiveness of their
drug. Instead, they would rely on such data provided by the New Drug Application
(NDA) held with respect to the innovator drug. However, to benefit from this
less costly abbreviated procedure, the ANDA applicant must demonstrate that its
drug is generic or bioequivalent to the innovator drug, and, to the extent
that patents protecting the innovator drug are listed in the Orange Book, the
ANDA applicant must write to the holder of the NDA for the innovator drug and the
patent holder (to the extent that the Orange Book-listed patents are not owned by
the holder of the NDA for the innovator drug) certifying that their product
either does not infringe the innovators and patent holders patents and/or that
the relevant patents are invalid. The innovator and the patent holder may sue the
ANDA applicant within 45 days of receiving the certification and, if they do so,
the U.S. Food and Drug Administration may not approve the ANDA for 30 months from
the date of certification unless, at some point before the expiry of those 30
months, a court makes a final decision in the ANDA applicants favor.
The Company is involved in
various sets of Paragraph IV litigations in the U.S. and similar suits
in Canada and France in respect of five different products: TriCor, Focalin
XR, Avinza, Luvox CR, and Megace ES either as plaintiff or
as an interested party (where the suit is being brought in the name of one of our collaborators).
20
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our condensed consolidated financial statements and related notes
beginning on page 3 of this Quarterly Report on Form 10-Q, and Managements
Discussion and Analysis of Financial Condition and Results of Operations included in (i) our Registration Statement on Form S-4, as
amended (Registration No. 333-175078), and the financial statements
and notes thereto which was declared effective
by the Securities and Exchange Commission (SEC) on
August 4, 2011, (the Registration Statement ) and (ii)
Alkermes, Inc.s Annual Report on Form 10-K for the year ended March
31, 2011, as amended (the Annual Report), and the audited
financial statements and notes thereto, which has been filed with the SEC.
Alkermes plc (as used in this section, together with our subsidiaries, us, we,
our, Alkermes or the Company) is a fully integrated, global biopharmaceutical company that
applies its scientific expertise and proprietary technologies to develop innovative
medicines that improve patient outcomes. We have a diversified portfolio of more than
20 commercial drug products and a substantial clinical pipeline of product candidates
that address central nervous system (CNS) disorders such as addiction, schizophrenia
and depression. Headquartered in Dublin, Ireland, we have a research and development
center and corporate offices in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland;
Gainesville, Georgia; and Wilmington, Ohio.
We leverage our formulation expertise and proprietary product platforms to
develop, both with partners and on our own, innovative and competitively advantaged
medications that can enhance patient outcomes in major therapeutic areas. We enter into
select collaborations with pharmaceutical and biotechnology companies to develop
significant new product candidates, based on existing drugs and incorporating our
proprietary product platforms. In addition, we apply our innovative formulation
expertise and drug development capabilities to create our own new, proprietary
pharmaceutical products.
Except where specifically noted or the context otherwise requires, the use of terms such as Alkermes and Company
and we and our and us in this Managements Discussion and Analysis of Financial Condition and Results of Operations
refers to Alkermes, to Alkermes, Inc., and to EDT, interchangeably.
Forward-Looking Statements
This document contains and incorporates by reference forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. In some cases, these statements can be identified by
the use of forward-looking terminology such as may, will, could, should,
would, expect, anticipate, continue or other similar words. These statements
discuss future expectations; contain projections of results of operations or of
financial condition, or state trends and known uncertainties or other forward looking
information. Forward-looking statements in this Quarterly Report on Form 10-Q include,
without limitation, statements regarding:
|
|
our expectations regarding our financial performance, including revenues,
expenses, gross margins, liquidity, capital expenditures and income taxes; |
|
|
|
our expectations regarding the commercialization of our products, including the sales and marketing efforts of our partners
and, for VIVITROL® (naltrexone for extended-release injectable suspension) our ability to establish and maintain
successful sales and marketing, reimbursement and distribution arrangements for our products;
|
|
|
|
our efforts and ability to evaluate and license product candidates and build
our pipeline; |
|
|
|
our expectations regarding our product candidates, including the development,
regulatory review (including expectations about regulatory approval and regulatory timelines) and therapeutic and commercial potential of such product
candidates and the costs and expenses related thereto; |
|
|
|
our expectations regarding the initiation, timing and results of clinical
trials of our products; |
|
|
|
our expectations regarding the successful manufacture of our products and
product candidates, by us or our partners for commercial
sale; |
|
|
|
the continuation of our collaborations and other significant agreements and our
ability to establish and maintain successful development collaborations; |
|
|
|
our expectations regarding the financial impact of health care reform
legislation and foreign currency exchange rate fluctuations and valuations; |
|
|
|
the impact of new accounting pronouncements; |
|
|
|
our beliefs regarding Adjusted EBITDA |
|
|
|
our ability to protect our intellectual property rights; |
|
|
|
our expectations regarding near-term changes in the nature of our market risk exposures or in managements objectives
and strategies with respect to managing such exposures; |
|
|
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our ability to comply with restrictive covenants of our indebtedness and our ability to fund our debt service obligations; |
|
|
|
our expectations concerning the status, intended use and financial impact of
and arrangements involving our properties, including manufacturing facilities; and |
|
|
|
our future capital requirements and capital expenditures and our ability to
finance our operations and capital requirements. |
You are cautioned that forward-looking statements are based on current expectations and are inherently uncertain. Actual
performance and results of operations may differ materially from those projected or suggested in the forward-looking
statements due to various risks and uncertainties, including the risks and uncertainties described or discussed in this Quarterly
Report on Form 10-Q and in our Registration Statement.
21
The forward-looking statements contained and incorporated herein represent our
judgment as of the date of this Quarterly Report, and we caution readers not to place
undue reliance on such statements. The information contained in this Quarterly Report
is provided by us as of the date of this Quarterly Report and, except as required by
law, we do not undertake any obligation to update any forward-looking statements
contained in this document as a result of new information, future events or otherwise.
Executive
Summary
On September 16, 2011, the business of Alkermes, Inc. and the drug technologies
business (EDT) of Elan Corporation, plc
(Elan) were combined (referred to as the Business
Combination, the acquisition of EDT, or the
EDT acquisition ) under Alkermes. As part of the Business Combination, Antler
Acquisition Corp., a wholly owned subsidiary of the Company, merged with and into
Alkermes, Inc. (the Merger), with Alkermes, Inc. surviving as a wholly owned
subsidiary of the Company. Prior to the Merger, EDT was carved-out of Elan and
reorganized under the Company. We paid Elan $500.0 million in cash and issued Elan 31.9
million ordinary shares, which had a fair value of
$525.1 million on the closing date, for the EDT business. Upon consummation of the Merger, the former shareholders of
Alkermes, Inc. owned approximately 75% of the Company, with the remaining approximately
25% of the Company owned by a subsidiary of Elan pursuant to the terms of a
shareholders agreement.
Prior to the acquisition, EDT developed and manufactured pharmaceutical products
that deliver clinical benefits to patients using EDTs experience and proprietary
drug technologies in collaboration with other pharmaceutical companies worldwide.
EDTs two principal drug technology platforms are the oral controlled release
platform (OCR) and the bioavailability enhancement platform, including EDTs
NanoCrystal ® technology. We acquired EDT to create a larger, faster-growing
biopharmaceutical company that is immediately, and that we anticipate will be
sustainably, profitable on a cash earnings basis with the goal of diversifying
our commercialized product portfolio and pipeline candidates, enhancing our
financial resources in order to invest in our proprietary drug candidates,
pursuing additional growth opportunities and reducing our cost of capital. For a
more detailed discussion of the Business Combination, please refer to the notes
to our condensed consolidated financial statements, including Note 1, The
Company, and Note 3, Acquisitions, in the accompanying Notes to Condensed
Consolidated Financial Statements.
The Business Combination is being accounted for using the acquisition method of accounting for business combinations with Alkermes, Inc. being
treated as the accounting acquirer under U.S. GAAP, which means that the operating results of Alkermes, Inc. are
included for all periods being presented, where as the operating results of the acquiree, EDT, are included
only after the date of acquisition through the end of the period. Accordingly, our financial results reflect the full quarter of operations of Alkermes, Inc.,
and 14 days of operations of the former EDT business, together with the consolidated
balance sheet as of September 30, 2011. Net loss for the three months ended September
30, 2011, was $22.3 million, or $0.22 per common share basic and diluted, as
compared to a net loss of $7.7 million, or $0.08 per common
share basic and diluted, for the three months ended September 30, 2010. Net loss for the six months ended
September 30, 2011, was $35.5 million, or $0.36 per common share basic and diluted,
as compared to a net loss of $21.1 million, or $0.22 per common share basic and
diluted, for the six months ended September 30, 2010.
As a complement to GAAP results, we are also providing a non-GAAP measure of
adjusted EBITDA (Adjusted EBITDA), which we believe better indicates underlying trends in ongoing
operations. Adjusted EBITDA excludes from GAAP results the following: interest expense,
taxes, depreciation and amortization, share-based compensation expense and certain
noncash or nonrecurring items. For the three and six months ended September 30, 2011,
we had Adjusted EBITDA of $13.3 million and $16.9 million, respectively as compared to
Adjusted EBITDA of $0.5 million and $(5.4) million for the three and six months ended
September 30, 2010, respectively. Refer to the reconciliation of net loss as calculated
under GAAP to Adjusted EBITDA under the caption Non-GAAP
Financial Measures.
KEY COMMERCIAL PRODUCTS
RISPERDAL CONSTA
RISPERDAL® CONSTA® (risperidone long-acting injection) is a product of
Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International AG, which we refer to as
Janssen, and
is the first and only long-acting, atypical antipsychotic approved by
the United States (U.S.) Food and
Drug Administration (FDA) for the treatment of schizophrenia and bipolar I disorder.
The medication uses our polymer-based microsphere injectable extended-release
technology to deliver and maintain therapeutic medication levels in the body through
one injection every two weeks. RISPERDAL CONSTA is marketed by Janssen and is sold in
more than 90 countries, and is exclusively manufactured by us. Alkermes earns
manufacturing revenues and royalties on worldwide sales of RISPERDAL CONSTA.
INVEGA® SUSTENNA®/XEPLION®
INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable suspension is
a product of Janssen and was approved in July 2009 in the U.S. for the acute and
maintenance treatment of schizophrenia in adults. It is the first once-monthly,
long-acting, injectable atypical antipsychotic approved for this use in the U.S. The
medication uses our nanoparticle injectable extended-release technology to increase the
rate of dissolution and enable the formulation of an aqueous suspension for
once-monthly intramuscular administration. INVEGA SUSTENNA is manufactured and
commercialized by Janssen. Paliperidone palmitate extended-release for injectable
suspension is also approved in the European Union (EU) and is commercialized in the
EU under the trade name XEPLION. We earn royalties on worldwide sales of INVEGA
SUSTENNA and XEPLION.
AMPYRA®/FAMPYRA®
AMPYRA (dalfampridine) is a product of Acorda Therapeutics and is a potassium
channel blocker approved by the FDA in January 2010 as a treatment to improve walking
in patients with multiple sclerosis (MS), as demonstrated by an increase
in walking speed. AMPYRA is the first and only product approved for this
indication. Efficacy was shown in people with all four major types of MS (relapsing
remitting, secondary progressive, progressive relapsing and primary progressive).
Acorda commercially launched AMPYRA in the U.S. in March 2010.
22
In June 2009, Acorda entered into an agreement with Biogen Idec for
commercialization of dalfampridine outside the U.S. In January 2010, Biogen Idec
announced that it submitted a centralized Marketing Authorization Application
to the European Medicines Agency (EMA) and a New Drug Submission (NDS) to Health
Canada for dalfampridine. Following a recommendation for conditional marketing
authorization from the EMAs Committee for Medicinal Products for Human Use in
May 2011, Biogen Idec received conditional approval in July 2011 from the European
Commission for dalfampridine for the improvement of walking in adult patients with MS
with walking disability. Biogen Idec commercializes dalfampridine in countries outside
the U.S. in which the product is approved, under the trade name FAMPYRA. Biogen Idec
received a Notice of Deficiency from Health Canada regarding its application for
approval of FAMPYRA in Canada, and it responded to the Notice of Deficiency in April
2011. Health Canada has approximately a year to reply to that response. In May 2011,
FAMPYRA was approved for use in Australia by the Australian Therapeutic Goods
Administration. Alkermes earns manufacturing revenues and royalties on worldwide sales
of AMPYRA and FAMPYRA.
VIVITROL
We developed, manufacture and commercialize VIVITROL
as the
first and only once-monthly injectable medication for the treatment of alcohol dependence and for the prevention of relapse to
opioid dependence, following opioid detoxification. VIVITROL was approved by the FDA in April 2006 for the treatment of
alcohol dependence and was launched in the U.S. in June 2006. VIVITROL was approved for the prevention of relapse to
opioid dependence following opioid detoxification in October 2010. We exclusively licensed the rights to commercialize
VIVITROL in Russia and the Commonwealth of Independent States to Cilag GmbH International in December 2007, and VIVITROL has been available in Russia for the treatment of alcohol dependence since March 2009 and
for the prevention of relapse to opioid dependence following opioid detoxification, since April 2011.
BYDUREON
We entered into an agreement with Amylin Pharmaceuticals, Inc.
(Amylin) in May 2000 for the development of a once weekly formulation of exenatide,
BYDUREON, for the treatment of type 2 diabetes. BYDUREON is a
long-acting injectable formulation of Amylins BYETTA® (exenatide). An NDA for BYDUREON was submitted to the FDA
in May 2009. The FDA issued complete response letters on the BYDUREON NDA to Amylin in March 2010 and in
October 2010. In the October 2010 complete response letter, the FDA requested a thorough QT (tQT) study with exposures
of exenatide at higher than typical therapeutic levels of BYDUREON, such as those that might be achieved in patients with
impaired renal function, and the submission of the results of the DURATION-5 clinical study to evaluate the efficacy, and the
labeling of the safety and effectiveness, of the commercial formulation of BYDUREON. In 2011, Amylin conducted a tQT
study in response to the complete response letter, and in July 2011,
we, Eli Lilly and Company (Lilly) and Amylin announced results of the study
and submitted a
reply to the complete response letter for the BYDUREON NDA, which included the results of the tQT study. The FDA
assigned a Prescription Drug User Fee Act action date of January 28, 2012 for BYDUREON.
In June 2011, the European Commission granted marketing authorization for BYDUREON
for the treatment of type 2 diabetes in adult patients in combination with metformin, a
sulfonylurea, a thiazolidinedione, metformin plus a sulfonylurea or metformin plus a
thiazolidinedione. Amylin licensed the rights to commercialize BYDUREON outside the
U.S. to Lilly. In July 2011, Lilly launched BYDUREON in the United Kingdom
and in September 2011, BYDUREON was launched in Germany. We received a $7.0 million
milestone payment upon first commercial sale of BYDUREON in the EU, which was
recognized during the quarter ended September 30, 2011. We are entitled to receive an
additional $7.0 million milestone payment upon first commercial launch of BYDUREON in the U.S., if
approved by the FDA. We earn royalties on sales of BYDUREON in territories in which it
is commercially sold.
23
ESTABLISHED LICENSED-PRODUCT PORTFOLIO
We have a portfolio of additional, established products marketed by our licensees.
These additional licensed products were part of EDT and we
earn manufacturing and/or royalty revenues for these products. The majority of these
products leverage our proprietary drug delivery technologies. These products include:
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Collaborator |
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Product |
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Indication |
|
Territory |
Abbott Laboratories
|
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TriCor® 145, Lipanthyl
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Cholesterol reduction
|
|
U.S. and Certain European
territories |
|
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Acorda Therapeutics, Inc.
|
|
Zanaflex® Capsules
|
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Muscle spasticity
|
|
U.S. |
|
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Jazz Pharmaceuticals Inc.
|
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Luvox CR®
|
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Obsessive-Compulsive Disorder
|
|
U.S. |
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Pfizer Inc.
|
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Avinza®
|
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Chronic pain
|
|
U.S. |
|
|
|
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Merck & Co., Inc.
|
|
Emend®
|
|
Nausea associated with chemotherapy
|
|
All major territories
worldwide |
|
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Novartis AG
|
|
Focalin XR®
Ritalin LA®
|
|
Attention Deficit Hyperactivity
Disorder
|
|
U.S. and Switzerland
All major territories
worldwide |
|
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|
Par Pharmaceutical Companies, Inc.
|
|
Megace® ES
|
|
Cachexia associated with AIDS
|
|
U.S. |
(Strativa) |
|
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|
Pfizer Inc.
|
|
Rapamune®
|
|
Renal transplant rejection
|
|
All major territories
worldwide |
|
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|
Shionogi Inc.
Sunovian Pharmaceuticals Canada, Inc.
|
|
Naprelan®
|
|
Pain
|
|
U.S.
Canada |
|
|
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UCB, Inc.
|
|
Verelan®, Verelan® PM
|
|
Hypertension
|
|
U.S. |
KEY DEVELOPMENT PROGRAMS
We have several proprietary and partnered product candidates in various stages of
development.
ALKS 37 is an orally active, peripherally restricted opioid antagonist for the
treatment of opioid-induced constipation, or OIC. In May 2011, we presented positive
results from a phase 2 double-blind, randomized, placebo-controlled, multi-dose
clinical study of ALKS 37 for the treatment of OIC. Data from the study showed that
ALKS 37 significantly improved gastrointestinal motility, demonstrated by increased
frequency of bowel movements in patients with OIC, while simultaneously preserving the
analgesic effects of opioid treatment. The study also demonstrated that ALKS 37 was
generally well tolerated with limited bioavailability and systemic exposure. In July
2011, we announced the initiation of a multicenter, randomized, double-blind,
placebo-controlled, repeat-dose phase 2b study of ALKS 37 to assess the safety,
tolerability, efficacy and pharmacokinetic profile of ALKS 37 in approximately 150
patients. In October 2011, we announced the initiation of a second phase 2b study of
ALKS 37. This multicenter, randomized, double-blind, placebo-controlled, fixed-dose
study is designed to assess the safety and efficacy of daily administration of a 100 mg
dose of ALKS 37 versus placebo for 12 weeks in approximately 80 patients with OIC. The
results of this phase 2b study, along with those from the dose-ranging, four-week phase
2b study initiated earlier in 2011, are expected in mid-calendar year 2012.
We are studying ALKS 9070 for the treatment of schizophrenia. ALKS 9070 is
designed to provide once-monthly dosing of a medication that converts in vivo into
aripiprazole, a molecule that is commercially available under the name
ABILIFY®. ALKS 9070 is our first product candidate to leverage our
proprietary LinkeRx product platform. In June 2011, we announced positive topline
results from a phase 1b, double-blind, randomized, placebo-controlled, 20-week study
that assessed the safety, tolerability and pharmacokinetic profile of a single administration
of three ascending doses of ALKS 9070 in 32 patients with chronic, stable
schizophrenia. Data from the study showed that ALKS 9070 was generally well tolerated,
achieved therapeutically relevant plasma concentrations of aripiprazole with a
pharmacokinetic profile that supports once-monthly dosing. Based on these results, we
plan to advance ALKS 9070 into pivotal development by the end of calendar year 2011.
ALKS 5461 is a combination of ALKS 33 and buprenorphine that we are
developing to be a non-addictive therapy for treatment-resistant depression (TRD) and
cocaine addiction. We initiated a multicenter, randomized, double-blind,
24
placebo-controlled phase 1b study of ALKS 5461 for the treatment of TRD in June 2011,
and we expect to announce the results of this study in early calendar year
2012.
We filed an
Investigational New Drug application (IND) for ALKS 5461 for the
treatment of cocaine addiction in June 2011 and started enrollment of a phase 1/2 study. This study is expected to be funded through a grant from the National
Institute on Drug Abuse (NIDA). NIDA has granted us up to $2.4 million to accelerate
the clinical development of ALKS 5461 for the treatment of cocaine addiction.
ALKS 33 is an oral opioid modulator that we are developing for the potential
treatment of addiction and other CNS disorders. In July 2011, we announced topline
results from a phase 2 clinical study of ALKS 33 in the treatment of binge eating
disorder. While ALKS 33 demonstrated a significant reduction from baseline in the
efficacy endpoint of self-reported weekly binge eating episodes, the reduction was not
significantly different from that observed with placebo. Based on these results, we
have determined that future studies in the binge eating indication are less attractive
than other potential alternatives and we will not pursue further development of ALKS 33
in this area. ALKS 33 remains in development for other CNS indications based on the
compounds favorable characteristics of once-daily dosing, limited hepatic metabolism
and durable pharmacologic activity in modulating brain opioid receptors. ALKS 33 is
currently being evaluated as a potential treatment for alcohol
dependence.
ZOHYDRO (hydrocodone bitartrate) extended-release capsules is a novel, oral,
single-entity (without acetaminophen), controlled-release formulation of hydrocodone in
development by Zogenix, Inc. (Zogenix) for the U.S. market. ZOHYDRO utilizes our oral controlled-release
technology, which potentially enables longer-lasting and more consistent pain relief
with fewer daily doses than the commercially available formulations of hydrocodone. In
August 2011, Zogenix announced positive top-line results from its pivotal phase 3
efficacy study of ZOHYDRO for the treatment of moderate to severe chronic pain in
patients requiring around-the-clock opioid therapy. Zogenix expects to submit an NDA
for ZOHYDRO to the FDA in early 2012. We will earn manufacturing revenues in the U.S. for ZOHYDRO
and are entitled to receive a royalty on U.S. sales of ZOHYDRO, if approved.
Meloxicam IV is a once-daily, rapid-onset, intravenous non-steroidal
anti-inflammatory drug that we are developing for the management of moderate
to moderately severe pain. Phase 2b studies of Meloxicam IV were completed in
2011, achieving all primary and secondary endpoints. We are continuing clinical
development of Meloxicam IV evaluating the efficacy, safety and tolerability in
post-operative patients.
A marketing authorization previously
filed in the U.K. for MORPHELAN®, a morphine product candidate, has been withdrawn.
Results of Operations
Manufacturing and Royalty Revenues
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Three Months Ended |
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Change |
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Six Months Ended |
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Change |
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September 30, |
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Favorable/ |
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September 30, |
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Favorable/ |
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(In millions) |
|
2011 |
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2010 |
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(Unfavorable) |
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2011 |
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2010 |
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(Unfavorable) |
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Manufacturing and royalty revenues: |
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|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
44.3 |
|
|
$ |
42.1 |
|
|
$ |
2.2 |
|
|
$ |
92.8 |
|
|
$ |
77.3 |
|
|
$ |
15.5 |
|
TRICOR 145 |
|
|
1.8 |
|
|
|
|
|
|
|
1.8 |
|
|
|
1.8 |
|
|
|
|
|
|
|
1.8 |
|
Other |
|
|
7.9 |
|
|
|
0.5 |
|
|
|
7.4 |
|
|
|
8.4 |
|
|
|
1.1 |
|
|
|
7.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing and royalty revenues |
|
$ |
54.0 |
|
|
$ |
42.6 |
|
|
$ |
11.4 |
|
|
$ |
103.0 |
|
|
$ |
78.4 |
|
|
$ |
24.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing fees are earned for the manufacture of products under arrangements
with our collaborators when product is shipped to them at an agreed upon price. Royalty
fees are earned on our collaborators sales of products that incorporate our
technologies. Royalties are generally recognized in the period the products are sold by
our collaborators.
The increase in RISPERDAL CONSTA manufacturing and royalty revenues for the three
months ended September 30, 2011, as compared to the three months ended September 30,
2010, was primarily due to a 6% increase in the unit net sales price earned on
manufacturing revenues and a 3% increase in royalty fees, partially offset by a 2%
decrease in the quantity shipped to Janssen. The increase in royalty fees is due to an
increase in Janssens end market sales of RISPERDAL CONSTA from $377.7 million during
the three months ended September 30, 2010 to $390.0 million during the three months
ended September 30, 2011. The increase in RISPERDAL CONSTA manufacturing revenues for
the six months ended September 30, 2011, as compared to the six months ended September
30, 2010, was primarily due to a 19% increase in the quantity shipped to Janssen, an 8%
increase in
royalty fees and a 5% increase in the unit net sales price earned on
manufacturing revenues. The increase in
25
royalty fees is due to an increase in Janssens
end market sales of RISPERDAL CONSTA from $733.4 million during the six months ended
September 30, 2010 to $793.6 million during the three months ended September 30, 2011.
Under our manufacturing and supply agreement with Janssen, we earn manufacturing
revenues when product is shipped to Janssen, based on a percentage of Janssens
estimated unit net sales price. Revenues include a quarterly adjustment from Janssens
estimated unit net sales price to Janssens actual unit net sales price for product
shipped. In the three and six months ended September 30, 2011 and 2010, our RISPERDAL
CONSTA manufacturing revenues were based on an average of 7.5% of Janssens unit net
sales price. We anticipate that we will continue to earn manufacturing revenues at 7.5%
of Janssens unit net sales price of RISPERDAL CONSTA for product shipped in the fiscal
year ending March 31, 2012 and beyond. Under our license agreements with Janssen, we
record royalty revenues equal to 2.5% of Janssens net sales of RISPERDAL CONSTA in the
period that the product is sold by Janssen. See Part I, Item 3. Quantitative and
Qualitative Disclosures about Market Risk for information on foreign currency exchange
rate risk related to RISPERDAL CONSTA revenues.
TRICOR 145 and the other manufacturing and royalty revenues were
primarily due to the addition of EDTs portfolio of
commercialized products from September 16, 2011, the closing
date of the Business Combination, through September 30, 2011.
Product Sales, net
Our product sales consist of sales of VIVITROL in the U.S. to wholesalers,
specialty distributors and specialty pharmacies. The following table presents the
adjustments deducted from VIVITROL product sales, gross to arrive at VIVITROL product
sales, net for sales of VIVITROL in the U.S. during the three and six months ended September 30,
2011 and 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
|
|
September 30, |
|
|
September 30, |
|
(In millions) |
|
2011 |
|
|
% of Sales |
|
|
2010 |
|
|
% of Sales |
|
|
2011 |
|
|
% of Sales |
|
|
2010 |
|
|
% of Sales |
|
Product sales, gross |
|
$ |
13.3 |
|
|
|
100.0 |
% |
|
$ |
10.8 |
|
|
|
100.0 |
% |
|
$ |
27.4 |
|
|
|
100.0 |
% |
|
$ |
18.2 |
|
|
|
100.0 |
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medicaid rebates |
|
|
(1.0 |
) |
|
|
(7.5) |
% |
|
|
(0.3 |
) |
|
|
(2.8) |
% |
|
|
(2.2 |
) |
|
|
(8.0) |
% |
|
|
(0.8 |
) |
|
|
(4.4) |
% |
Chargebacks |
|
|
(1.0 |
) |
|
|
(7.5) |
% |
|
|
(0.5 |
) |
|
|
(4.6) |
% |
|
|
(2.1 |
) |
|
|
(7.7) |
% |
|
|
(0.9 |
) |
|
|
(4.9) |
% |
Reserve for inventory in the channel
(1) |
|
|
|
|
|
|
|
% |
|
|
(2.1 |
) |
|
|
(19.4) |
% |
|
|
(0.7 |
) |
|
|
(2.6) |
% |
|
|
(1.7 |
) |
|
|
(9.3) |
% |
Other |
|
|
(1.4 |
) |
|
|
(10.6) |
% |
|
|
(1.4 |
) |
|
|
(13.0) |
% |
|
|
(2.8 |
) |
|
|
(10.2) |
% |
|
|
(2.1 |
) |
|
|
(11.6) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
(3.4 |
) |
|
|
(25.6) |
% |
|
|
(4.3 |
) |
|
|
(39.8) |
% |
|
|
(7.8 |
) |
|
|
(28.5) |
% |
|
|
(5.5 |
) |
|
|
(30.2) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
9.9 |
|
|
|
74.4 |
% |
|
$ |
6.5 |
|
|
|
60.2 |
% |
|
$ |
19.6 |
|
|
|
71.5 |
% |
|
$ |
12.7 |
|
|
|
69.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Our reserve for inventory in the channel is an estimate that reflects the deferral of the recognition of revenue
on shipments of VIVITROL to our customers until the product has left the distribution channel as we do not yet
have the history to reasonably estimate returns related to these shipments. We estimate the product shipments out
of the distribution channel through data provided by external sources, including information on inventory levels
provided by our customers as well as prescription information. |
The increase in product sales, gross for the three months ended September 30,
2011, as compared to the three months ended September 30, 2010, was primarily due to a
19% increase in price and a 3% increase in the number of units sold. The
increase in product sales, gross for the six months ended September 30, 2011, as
compared to the six months ended September 30, 2010, was primarily due to a 26%
increase in the number of units sold and a 19% increase in price. The increase in
Medicaid rebates during the three and six months ended September 30, 2011, as compared
to the three and six months ended September 30, 2010, is primarily due to higher
rebates resulting from a price increase in October 2010 and the
impact of increased
Medicaid rebates and the extension of Medicaid rebates to Medicaid managed care organizations. The
increase in chargebacks during the three and six months ended September 30, 2011, as
compared to the three and six months ended September 30, 2010, is primarily due to the
increase in the price of VIVITROL and increased Public Health Service pricing
discounts. The decrease in the reserve for inventory in the channel during the three
and six months ended September 30, 2011, as compared to the three and six months ended
September 30, 2010, is primarily due to a decrease in the amount of VIVITROL shipped in
the month of September 2011 as compared to the month of September 2010.
26
Research and development revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Research and development revenue |
|
$ |
8.1 |
|
|
$ |
0.2 |
|
|
$ |
7.9 |
|
|
$ |
11.3 |
|
|
$ |
0.4 |
|
|
$ |
10.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (R&D) revenue is generally earned for services
performed and milestones achieved under arrangements with our collaborators. The
increase in R&D revenue for the three months ended September 30, 2011, as compared to
the three months ended September 30, 2010, was primarily due to the recognition of a
$7.0 million milestone payment we earned upon the first sale of BYDUREON in the E.U. in
July 2011. The increase in R&D revenue for the six months ended September 30, 2011, as
compared to the six months ended September 30, 2010, was primarily due to the $7.0
million BYDUREON milestone payment as well as a $3.0 million milestone payment we earned upon
the receipt of regulatory approval for VIVITROL in Russia for the opioid dependence
indication in April 2011.
Costs and Expenses
Cost of Goods Manufactured and Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Cost of goods manufactured and sold |
|
$ |
17.5 |
|
|
$ |
13.9 |
|
|
$ |
(3.6 |
) |
|
$ |
33.7 |
|
|
$ |
26.6 |
|
|
$ |
(7.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in cost of goods manufactured and sold in the three months ended
September 30, 2011, as compared to the three months ended September 30, 2010, was
primarily due to $4.9 million of cost of goods manufactured from the addition of EDTs
portfolio of commercialized products from the completion of the Business Combination on
September 16, 2011 through September 30, 2011, partially offset by a $1.8 million
decrease in RISPERDAL CONSTA cost of goods manufactured due to a decrease in the number
of units shipped to Janssen. The increase in cost of goods manufactured and sold in the
six months ended September 30, 2011, as compared to the six months ended September 30,
2010, was primarily due to the additional $4.9 million of cost of goods manufactured
from EDT, an $1.1 million increase in VIVITROL cost of goods manufactured and sold due to an
increase in the number of units sold and a $0.9 million increase in RISPERDAL CONSTA
cost of goods manufactured related to an increase in the number of units shipped
to Janssen.
Research and Development Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Research and development |
|
$ |
28.2 |
|
|
$ |
23.9 |
|
|
$ |
(4.3 |
) |
|
$ |
56.2 |
|
|
$ |
46.9 |
|
|
$ |
(9.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in R&D expenses in the three months ended September 30, 2011, as
compared to the three months ended September 30, 2010, was primarily due to a $4.4
million increase in costs incurred in connection with our ALKS 37 and ALKS 9070
development programs and a $1.9 million increase in employee-related expense due to an
increase in headcount within the legacy Alkermes, Inc. business, partially offset by a $1.4
million decrease in laboratory expenses and a $0.7 million decrease in license and
collaboration fees under our collaboration agreement with Acceleron.
The increase in R&D expenses in the six months ended September 30, 2011, as
compared to the six months ended September 30, 2010, was primarily due to a $5.6
million increase in professional services, a $4.0 million increase in employee related
expense and a $2.8 million increase in preclinical and clinical study expense,
partially offset by a $2.1 million decrease in license and collaboration fees.
The increase in professional services and preclinical and clinical study expense
was primarily due to activity related to our ALKS 37 and ALKS 9070 development
programs, and the increase in employee-related expense is primarily due to an
increase in headcount within the legacy Alkermes, Inc. business and share-based
compensation expense as recent equity grants have been awarded with a higher grant-date
fair value than older grants. The decrease in license and collaboration expense was
primarily due to a decrease in expense under our collaboration agreement with
Acceleron.
A significant portion of our R&D expenses (including laboratory supplies, travel,
dues and subscriptions, recruiting costs, temporary help costs, consulting costs and
allocable costs such as occupancy and depreciation) are not tracked by project as they
benefit multiple projects or our technologies in general. Expenses incurred to purchase
specific services from third parties to support our collaborative research and
development activities are tracked by project and may be reimbursed to us by our
27
partners. We account for our research and development expenses on a departmental and
functional basis in accordance with our budget and management practices.
Selling, General and Administrative Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Selling, general and administrative |
|
$ |
36.2 |
|
|
$ |
18.4 |
|
|
$ |
(17.8 |
) |
|
$ |
67.7 |
|
|
$ |
38.2 |
|
|
$ |
(29.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
increase in selling general and administrative (SG&A) costs for the three months ended September 30, 2011, as
compared to the three months ended September 30, 2010, was primarily due to a $12.7
million increase in professional services, a $2.4 million increase in employee related
expenses and the addition of $1.0 million in SG&A costs related to the EDT business.
The increase in professional services was primarily due to costs incurred in connection
with the Business Combination. The increase in employee-related expenses was primarily due
to an increase in headcount and share-based compensation expense as recent equity
grants have been awarded with a higher grant-date fair value than older grants.
The increase in SG&A costs for the six months ended September 30, 2011, as
compared to the six months ended September 30, 2010, was primarily due to a $21.5
million increase in professional services, a $4.0 million increase in employee-related
expenses and the addition of $1.0 million in SG&A costs related to the EDT business.
The increase in professional services was primarily due to costs incurred in connection
with the Business Combination. The increase in employee related expenses was primarily due
to an increase in headcount and share-based compensation expense as recent equity
grants have been awarded with a higher grant-date fair value than older grants.
Amortization of Acquired Intangible Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Amortization of acquired intangible assets |
|
$ |
1.8 |
|
|
$ |
|
|
|
$ |
(1.8 |
) |
|
$ |
1.8 |
|
|
$ |
|
|
|
$ |
(1.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In connection with the Business Combination, we acquired certain amortizable intangible
assets with a fair value of $643.8 million, which are expected to be amortized over 12
to 13 years. We also acquired $46.0 million of intangible assets related to various
preclinical product candidates, or in-process research, and $105.0 million of goodwill,
both of which are considered indefinite-lived assets and not amortized, but are subject
to an annual review for impairment or when circumstances indicate the fair value may be
below its carrying value.
Other Income (Expense), Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Total other (expense), net |
|
$ |
(6.8 |
) |
|
$ |
(1.6 |
) |
|
$ |
(5.2 |
) |
|
$ |
(6.3 |
) |
|
$ |
(2.0 |
) |
|
$ |
(4.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in other (expense), net for the three and six months ended September
30, 2011, as compared to the three and six months ended September 30, 2010, was
primarily due to our entry into $450.0 million of term loan financing during the
three months ended September 30, 2011. The $310.0 million first lien term loan facility (the First Lien Term Loan) has a principal
amount of $310.0 million and pays interest at three-month LIBOR plus 5.25% and the
$140.0 million second lien term loan facility (the Second Lien
Term Loan and together the Term Loans) has a principal amount of $140.0 million and pays interest at
three-month LIBOR plus 8.00%. Under both loan agreements, three-month LIBOR is subject to an
interest rate floor of 1.50%.
Income Tax Provision (Benefit)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Six Months Ended |
|
|
Change |
|
|
|
September 30, |
|
|
Favorable/ |
|
|
September 30, |
|
|
Favorable/ |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
|
2011 |
|
|
2010 |
|
|
(Unfavorable) |
|
Income tax provision (benefit) |
|
$ |
3.7 |
|
|
$ |
(0.9 |
) |
|
$ |
(4.6 |
) |
|
$ |
3.6 |
|
|
$ |
(1.0 |
) |
|
$ |
4.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in the income tax provision in the three and six months ended
September 30, 2011, as compared to the three and six months ended September 30, 2010,
is primarily due to the $13.2 million current tax expense related to the taxable
transfer of the BYDUREON intellectual property from the U.S. to Ireland and a deferred
tax benefit of $9.5 million in connection with the Business Combination, as the Company recorded
a U.S. deferred tax liability in purchase accounting allowing for the partial release
of an existing valuation allowance recorded during the three months ended September 30,
2011.
28
Non-GAAP
Financial Measures
We use Adjusted EBITDA as a supplemental measure of our performance and liquidity that is
not required by, or presented in accordance with,
GAAP. We define Adjusted EBITDA as net income (loss) before
(i) interest expense, (ii) income taxes, (iii) depreciation and amortization, (iv)
non-cash expenses relating to share based arrangements with our
employees and (v) professional fees related to the Business
Combination. In
evaluating our business, we consider Adjusted EBITDA as a key indicator of financial
operating performance and as a measure of our ability to generate cash for operations
and future capital expenditures.
Adjusted EBITDA is not a GAAP measure of performance. We use this non-GAAP measure
primarily as a measure of the financial performance of our assets without regard to
financing methods, capital structures, taxes or historical cost basis; our liquidity
and operating performance over time and in relation to other companies that own similar
assets and that we believe calculate EBITDA in a manner similar to us; and the ability
of our assets to generate cash sufficient for us to pay potential interest expenses. We
believe that this measure may also be useful to investors for the same purpose and for
an indication of our ability to generate cash flow at a level that can sustain or
support our operations. Investors should not consider this measure in isolation or as a
substitute for operating income or loss, cash flow from operations determined under
GAAP, or any other measure for determining our operating performance that is calculated
in accordance with GAAP. In addition, because EBITDA is not a GAAP measure, it may not
necessarily be comparable to similarly titled measures employed by other companies.
In evaluating Adjusted EBITDA, you should be aware that it excludes expenses that
we will incur in the future on a recurring basis. Adjusted EBITDA has limitations as an
analytical tool, and you should not consider it in isolation. Some of its limitations
are:
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|
it does not reflect non-cash costs of our share based arrangements, which are
an ongoing component of our employee compensation program; and |
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|
|
although depreciation and amortization are non-cash charges, the assets being
depreciated and amortized will often have to be replaced in the future, and
Adjusted EBITDA does not reflect the cost or cash requirements for such
replacements. |
We compensate for these limitations by relying primarily on our GAAP results and
using Adjusted EBITDA only supplementally. The following table presents a
reconciliation of our net income to our Adjusted EBITDA on a historical basis for each
of the periods indicated:
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Three Months Ended |
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Six Months Ended |
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September 30, |
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September 30, |
|
(In millions) |
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Net loss,
GAAP |
|
$ |
(22.3 |
) |
|
$ |
(7.7 |
) |
|
$ |
(35.5 |
) |
|
$ |
(21.1 |
) |
Depreciation expense included in cost of goods manufactured and sold |
|
|
1.5 |
|
|
|
1.0 |
|
|
|
2.4 |
|
|
|
2.0 |
|
Depreciation expense included in R&D |
|
|
0.8 |
|
|
|
0.7 |
|
|
|
1.6 |
|
|
|
1.2 |
|
Depreciation expense included in SG&A |
|
|
0.4 |
|
|
|
0.3 |
|
|
|
0.6 |
|
|
|
0.7 |
|
Share-based compensation included in cost of goods manufactured and sold |
|
|
0.5 |
|
|
|
0.5 |
|
|
|
1.0 |
|
|
|
0.9 |
|
Share-based compensation included in R&D |
|
|
2.3 |
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|
|
1.6 |
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|
|
4.2 |
|
|
|
3.2 |
|
Share-based compensation included in SG&A |
|
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4.2 |
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|
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2.8 |
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7.4 |
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5.4 |
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Amortization of acquired intangible assets |
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1.8 |
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|
|
|
|
|
|
1.8 |
|
|
|
|
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Interest expense |
|
|
7.6 |
|
|
|
2.2 |
|
|
|
7.6 |
|
|
|
3.3 |
|
Income tax expense |
|
|
3.7 |
|
|
|
(0.9 |
) |
|
|
3.6 |
|
|
|
(1.0 |
) |
Professional
fees related to the Business Combination included in SG&A |
|
|
12.8 |
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|
|
|
|
|
22.2 |
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|
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|
|
|
|
|
Adjusted EBITDA |
|
$ |
13.3 |
|
|
$ |
0.5 |
|
|
$ |
16.9 |
|
|
$ |
(5.4 |
) |
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Liquidity and Capital Resources
Our financial condition is summarized as follows:
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|
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September 30, |
|
|
March 31, |
|
(In millions) |
|
2011 |
|
|
2011 |
|
Cash and cash equivalents |
|
$ |
89.2 |
|
|
$ |
38.4 |
|
Investments short-term |
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|
126.3 |
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|
|
162.9 |
|
Investments long-term |
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|
25.0 |
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|
|
93.4 |
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|
|
|
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|
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Total cash, cash equivalents and investments |
|
$ |
240.5 |
|
|
$ |
294.7 |
|
|
|
|
|
|
|
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Working capital |
|
$ |
265.4 |
|
|
$ |
204.9 |
|
Long-term debt |
|
$ |
444.2 |
|
|
$ |
|
|
29
Our cash flows for the six months ended September 30, 2011 and 2010 were as
follows:
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Six Months Ended |
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|
|
September 30, |
|
(In millions) |
|
2011 |
|
|
2010 |
|
Cash and cash equivalents, beginning of period |
|
$ |
38.4 |
|
|
$ |
79.3 |
|
Cash (used in) operating activities |
|
|
(15.6 |
) |
|
|
(27.1 |
) |
Cash (used in) provided by investing activities |
|
|
(393.0 |
) |
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|
29.1 |
|
Cash provided by (used in) financing activities |
|
|
459.4 |
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|
(44.0 |
) |
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Cash and cash equivalents, end of period |
|
$ |
89.2 |
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|
$ |
37.3 |
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|
Our primary sources of liquidity are cash provided by past operating activities,
payments we have received under R&D arrangements and other arrangements with
collaborators, term loan financing and private placements of debt securities. The
decrease in cash used in operating activities during the six months ended September 30,
2011, as compared to the six months ended September 30, 2010, is primarily due to a
decrease in cash used for working capital and a decrease in cash principal payments on
our 7% Notes that was allocated to operating activities to account for the original
issue discount on our non-recourse RISPERDAL CONSTA secured 7% Notes (the 7% Notes). The change in cash flows (used in)/provided by
investing activities during the six months ended September 30, 2011, as compared to the
six months ended September 30, 2010, is primarily due to the acquisition of EDT. The
increase in cash flows provided by financing activities during the six months ended
September 30, 2011, as compared to the six months ended September 30, 2010, is
primarily due to the issuance of the Term Loans used to finance the acquisition of EDT.
We redeemed the balance of the 7% Notes in full on July 1, 2010.
Our investments at September 30, 2011 consist of the following:
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|
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|
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Amortized |
|
|
Gross Unrealized |
|
|
Estimated |
|
(In millions) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Investments short-term |
|
$ |
126.1 |
|
|
$ |
0.3 |
|
|
$ |
(0.1 |
) |
|
$ |
126.3 |
|
Investments long-term available-for-sale |
|
|
19.6 |
|
|
|
|
|
|
|
(0.5 |
) |
|
|
19.1 |
|
Investments long-term held-to-maturity |
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
151.6 |
|
|
$ |
0.3 |
|
|
$ |
(0.6 |
) |
|
$ |
151.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our investment objectives are, first, to preserve liquidity and conserve
capital and, second, to generate investment income. We mitigate credit risk in our cash
reserves by maintaining a well diversified portfolio that limits the amount of
investment exposure as to institution, maturity and investment type. However, the value
of these securities may be adversely affected by the instability of the global
financial markets which could, in turn, adversely impact our financial position and our
overall liquidity. Our available-for-sale investments consist primarily of short and
long-term U.S. government and agency debt securities, debt securities issued by foreign
agencies and backed by foreign governments and corporate debt securities. Our
held-to-maturity investments consist of investments that are restricted and held as
collateral under certain letters of credit related to certain of our lease agreements.
We classify available-for-sale investments in an unrealized loss position, which
do not mature within 12 months, as long-term investments. We have the intent and
ability to hold these investments until recovery, which may be at maturity, and it is
more likely than not that we would not be required to sell these securities before
recovery of their amortized cost. At September 30, 2011, we performed an analysis of our investments with unrealized
losses for impairment and determined that they are temporarily impaired.
Borrowings
At September 30, 2011, our borrowings consisted of $450.0 million of term loan
financing under the Term Loans. Please refer to Note 10 Long-Term Debt in the accompanying Notes to
Condensed Consolidated Financial Statements for a discussion of our outstanding term
loans.
30
Contractual Obligations
During
quarter ended, September 30, 2011, we entered into the Term Loans and assumed certain
operating lease and purchase obligations related to the Business
Combination. The following
table summarizes the
additions to our contractual obligations table that appeared within
Part II of Alkermes Inc.s Annual Report:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
One to |
|
|
Three to |
|
|
More than |
|
|
|
|
|
|
|
Less Than |
|
|
Three Years |
|
|
Five Years |
|
|
Five Years |
|
|
|
|
|
|
|
One Year |
|
|
(Fiscal 2013- |
|
|
(Fiscal 2015- |
|
|
(After Fiscal |
|
Contractual
Cash Obligations (in thousands) |
|
Total |
|
|
(Fiscal 2012) |
|
|
2014) |
|
|
2016) |
|
|
2017) |
|
Term Loans Principal |
|
$ |
450,000 |
|
|
$ |
775 |
|
|
$ |
6,200 |
|
|
$ |
6,200 |
|
|
$ |
436,825 |
|
Term Loans Interest |
|
|
218,939 |
|
|
|
16,162 |
|
|
|
69,051 |
|
|
|
68,294 |
|
|
|
65,432 |
|
Operating lease obligations |
|
|
866 |
|
|
|
102 |
|
|
|
382 |
|
|
|
382 |
|
|
|
|
|
Purchase obligations |
|
|
6,454 |
|
|
|
6,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expansion programs |
|
|
10,641 |
|
|
|
10,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations |
|
$ |
686,900 |
|
|
$ |
34,134 |
|
|
$ |
75,633 |
|
|
$ |
74,876 |
|
|
$ |
502,257 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We
pay interest under our Term Loans at three-month LIBOR plus 5.25% with respect
to our First Lien Term Loan and at three-month LIBOR plus 8.00% with respect to our Second
Lien Term Loan. Under each term loan agreement, LIBOR is subject to an interest rate
floor of 1.50%. For the purposes of the contractual obligation table, interest has been
calculated at the interest rate floor of 1.50% plus 5.25% and 8.00% for the first and
second lien term loans, respectively.
Off-Balance Sheet Arrangements
At September 30, 2011, we were not a party to any off-balance sheet arrangements
that have, or are reasonably likely to have, a current or future effect on our
financial condition, changes in financial condition, revenue or expenses, results of
operations, liquidity, capital expenditures or capital resources material to investors.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations
is based on our financial statements, which have been prepared in accordance with GAAP.
The preparation of these financial statements requires us to make estimates and
assumptions that affect the reported amounts of assets and liabilities and the
disclosure of contingent assets and liabilities at the date of our financial statements
and the reported amounts of revenues and expenses during the reporting period. Actual
results may differ from these estimates under different assumptions or conditions.
Refer to Part II, Item 7 of Alkermes, Inc.s Annual Report in the Critical Accounting Estimates section for a discussion of
our critical accounting estimates.
On April 1, 2011, we prospectively adopted the accounting guidance related to the
milestone method of revenue recognition for research and development arrangements.
Refer to New Accounting Pronouncements included in Note 2, Summary of Significant
Accounting Policies in the accompanying Notes to Condensed Consolidated Financial
Statements for a discussion of the impact the adoption of this standard had on us.
In connection with the acquisition of EDT on September 16, 2011, we added to our
listing of our most significant critical accounting estimates the valuation of acquired
intangible assets, including in-process research and development (IPR&D). These
intangible assets consist primarily of collaboration agreements, technology associated
with human therapeutic products and IPR&D product candidates. When significant
identifiable intangible assets are acquired, we engage an independent third-party
valuation firm to assist in determining the fair values of these assets as of the
acquisition date. Discounted cash flow models are typically used in these valuations,
which require the use of significant estimates and assumptions, including but not
limited to:
|
|
|
estimating the timing of and expected costs to complete the
in-process projects; |
|
|
|
|
projecting regulatory approvals; |
|
|
|
|
estimating future cash flows from product sales resulting
from completed products and in-process projects; and |
|
|
|
|
developing appropriate discount rates and probability rates by project. |
31
We believe the fair values assigned to the intangible assets acquired are based
upon reasonable estimates and assumptions given available facts and circumstances as of
the acquisition dates.
If these projects are not successfully developed, the sales and profitability of
the company may be adversely affected in future periods. Additionally, the value of the
acquired intangible assets may become impaired. We believe that the foregoing
assumptions used in the IPR&D analysis were reasonable at the time of the respective
acquisition. No assurance can be given, however, that the underlying assumptions used
to estimate expected project sales, development costs or profitability, or the events
associated with such projects, will transpire as estimated.
In connection with the acquisition of EDT, we recorded goodwill of $105.0 million
which represents the excess cost of the Companys investment in the net assets of
acquired companies over the fair value of the underlying identifiable net assets at the date of acquisition.
The Companys goodwill balance solely relates to the EDT acquisition in fiscal
year 2012. We assess our goodwill balance within our single reporting unit
annually and whenever events or changes in circumstances indicate the carrying
value of goodwill may not be recoverable to determine whether any impairment in this asset may exist and, if so, the extent of such
impairment. In performing our annual goodwill impairment assessment, we first assess
qualitative factors to determine whether it is necessary to perform the current
two-step test. If we believe, as a result of our qualitative assessment, that it
is more-likely-than-not that the fair value of the reporting unit is less than
its carrying amount, the quantitative impairment test is required. Otherwise, no further testing is
required. If, based on our qualitative assessment, we are required to proceed to the
quantitative assessment, we first compare the fair value of our reporting unit to
its carrying value. If the carrying value of the net assets assigned to our
reporting unit exceeds the fair value of our reporting unit, then the second step
of the impairment test is performed in order to determine the implied fair value
of our reporting units goodwill. If the carrying value of our reporting units
goodwill exceeds its implied fair value, then the company records an impairment loss equal to the difference. We will perform our required annual goodwill impairment assessment during the third quarter of fiscal year 2012.
New Accounting Standards
Refer
to New Accounting Pronouncements included in Note 2, Summary of Significant
Accounting Policies in the accompanying Notes to Condensed Consolidated Financial
Statements for a discussion of new accounting standards.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Market
risks related to our investment portfolio, and the ways we manage
such risks, are summarized in Part II, Item 7A, Quantitative and Qualitative Disclosures
About Market Risk of Alkermes, Inc.s Annual Report. We regularly review our marketable securities holdings and shift our
investment holdings to those that best meet our investment objectives, which are,
first, to preserve liquidity and conserve capital and, second, to generate investment
income. Apart from such adjustments to our investment portfolio, there have been no
material changes to our market risks in the first six months of fiscal year 2012, and
we do not anticipate any near-term changes in the nature of our market risk exposures
or in our managements objectives and strategies with respect to managing such
exposures.
In September 2011, we entered into the $310.0 million First Lien Term Loan and the
$140.0 million Second Lien Term Loan with certain of our subsidiaries, as guarantors,
Morgan Stanley Senior Funding, Inc., (MSSF) as administrative agent and as collateral
agent, MSSF and HSBC Securities (USA) Inc., (HSBC) as
co-syndication agents, joint lead arrangers and joint bookrunners, and various other
financial institutions, as lenders. Borrowings under the Term Loan Facilities bear
interest at a rate per annum equal to an applicable margin plus, at
our option, either (1) LIBOR determined by reference to the costs of funds for eurodollar
deposits for the interest period relevant to such borrowing adjusted for certain
additional costs or (2) a base rate determined by reference to the highest of (a) the
rate the Wall Street Journal publishes as the U.S. Prime Rate, (b) the federal funds
effective rate plus one-half of 1.00% and (c) LIBOR described in subclause (1) plus
1.00%. LIBOR is subject to an interest rate floor of 1.50% and the base rate is subject
to an interest rate floor of 2.50%.
The initial applicable margin for borrowings under the First Lien Term Loan is
5.25% with respect to LIBOR borrowings and 4.25% with respect to base rate borrowings.
Commencing with completion of our first fiscal quarter ending after the
Merger, the applicable margin under the First Lien Term Loan is subject to adjustment
each fiscal quarter, based upon meeting a certain consolidated leverage ratio during
the preceding quarter. The initial applicable margin for borrowings under the Second
Lien Term Loan is 8.00% with respect to LIBOR borrowings and 7.00% with respect to base
rate borrowings and is not subject to adjustment.
In
accordance with the terms of the Term Loans, we entered into an interest
rate cap and an interest rate swap agreement to mitigate the interest rate risk on
$65.0 million principal amount of our term loans. The interest rate cap protects us if
three-month LIBOR were to reach 1.78% from the date of issuance through December 3,
2012 and the interest rate swap protects us if three-month LIBOR were to reach 2.057%
from December 3, 2012 through September 3, 2014. As the three-month LIBOR rate was
0.35% at September 30, 2011, the LIBOR floor under the agreement
is 1.50% and as our
interest rate cap fixes our interest rate at 1.78% for $65.0 principal amount of our term loans,
we do not expect changes in the three-month LIBOR to have a material effect on our
financial statements through March 31, 2012.
We do not use derivative financial instruments for speculative trading purposes.
The counterparties to our interest rate cap and interest rate swap contracts are
multinational commercial banks. We believe the risk of counterparty nonperformance is
remote.
As
a result of the Business Combination we incur substantial operating costs in
Ireland. We face exposure to changes in the exchange ratio of the U.S. dollar and the
Euro arising from expenses and payables at our Ireland operations that are settled in
Euros. The impact of changes in the exchange ratio of the U.S. dollar and the Euro on
our U.S. dollar denominated manufacturing and royalty revenues earned in foreign
countries is partially offset by the opposite impact of changes in the exchange ratio
of the U.S. dollar and the Euro on operating expenses and payables incurred at our
Ireland operations that are settled in Euros. For the remainder of fiscal year 2012, an
average 10% weakening in the U.S. dollar relative to the Euro would result in an
increase to our budgeted expenses denominated in the Euro of $4.5 million.
32
As summarized in Part II, Item 7A, Quantitative and Qualitative Disclosures About
Market Risk of Alkermes, Inc.s Annual Report we are exposed to foreign currency fluctuations related to manufacturing and
royalty revenues we receive on RISPERDAL CONSTA as a majority of these sales are made
in foreign countries and are denominated in currencies in which the product is sold,
which is predominately the Euro. For the six months ended September 30, 2011, an
average 10% strengthening of the U.S. dollar relative to the currencies in which
RISPERDAL CONSTA is sold would have resulted in our RISPERDAL CONSTA manufacturing and
royalty revenues being reduced by approximately $5.4 million and $1.4 million,
respectively.
Item 4. Controls and Procedures
a) Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of the design and operation of our
disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities
Exchange Act of 1934, as amended, (the Exchange Act) at September 30, 2011. Based on
that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures were effective as of September 30, 2011 to
provide reasonable assurance that the information required to be disclosed by us in the
reports that we file 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 our management, including our Chief
Executive Officer and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure. In designing and evaluating our disclosure
controls and procedures, our management recognized that any controls and procedures, no
matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and our management necessarily was required
to apply its judgment in evaluating the cost-benefit relationship of possible controls
and procedures.
b) Change in Internal Control over Financial Reporting
As
discussed above, on September 16, 2011, the business of Alkermes, Inc. and
EDT were combined under Alkermes plc in a transaction accounted for as a reverse
acquisition. For purposes of the Business Combination, Alkermes, Inc.
was treated as the accounting acquirer under the
purchase method of accounting, even though Alkermes plc is the issuer of ordinary
shares in the transaction. As Alkermes, Inc. was determined to be the acquirer for
accounting purposes, the historical financial statements of Alkermes plc reflect the
financial position, results of operations and cash flows of Alkermes, Inc. only.
Following the Merger, the financial statements of the current period reflect the
financial position, results of operations and cash flows of Alkermes plc. The results
of operations of EDT are included in the results of operations of Alkermes plc
beginning on September 17, 2011.
Other than changes to our processes as a result of the Business
Combination, there have been no material changes to our internal
control over financial reporting that have materially affected, or
are reasonably likely to materially affect, our internal control over
financial reporting.
33
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
The Company and/or the Companys product partners are involved in various
so-called Paragraph IV litigation proceedings in the U.S. In the U.S., putative
generics of innovator drug products (including products in which the innovation
comprises a new drug delivery method for an existing product, such as the drug
delivery market occupied by the Company) may file Abbreviated New Drug
Applications (ANDAs) and, in doing so, they are not required to include
preclinical and clinical data to establish safety and effectiveness of their
drug. Instead, they would rely on such data provided by the New Drug Application
(NDA) held with respect to the innovator drug. However, to benefit from this
less costly abbreviated procedure, the ANDA applicant must demonstrate that its
drug is generic or bioequivalent to the innovator drug, and, to the extent
that patents protecting the innovator drug are listed in the Orange Book, the
ANDA applicant must write to the holder of the NDA for the innovator drug and the
patent holder (to the extent that the Orange Book-listed patents are not owned by
the holder of the NDA for the innovator drug) certifying that their product
either does not infringe the innovators and patent holders patents and/or that
the relevant patents are invalid. The innovator and the patent holder may sue the
ANDA applicant within 45 days of receiving the certification and, if they do so,
the U.S. Food and Drug Administration may not approve the ANDA for 30 months from
the date of certification unless, at some point before the expiry of those 30
months, a court makes a final decision in the ANDA applicants favor.
We
are involved in various sets of Paragraph IV litigations in the U.S. and similar suits in Canada and
France in respect of five different products: TriCor, Focalin XR, Avinza,
Luvox CR, and Megace ES either as plaintiff or as an interested party (where the suit is being
brought in the name of one of our collaborators).
Item 1A. Risk Factors
The following information updates should be read in conjunction with the
information disclosed in Part 1, Item 1A, Risk Factors, of the Alkermes, Inc.
Annual Report. You should also read the following information together with
those risk factors set forth under the caption Risk Factors in our Registration
Statement, which risk factors are incorporated herein by reference. There have
been no material changes from the Risk Factors set forth, or incorporated by
reference, in such Registration Statement except for the addition of the following Risk Factor.
Our investments are subject to general credit, liquidity, market and interest rate risks,
which may be exacerbated by the volatility in the United States credit markets.
As of September 30, 2011, a significant amount of our investments were invested in U.S.
government treasury and agency securities. Our investment objectives are, first, to preserve
liquidity and conserve capital and, second, to generate investment income. Should our investments
cease paying or reduce the amount of interest paid to us, our interest income would suffer. In
addition, general credit, liquidity, market and interest risks associated with our investment
portfolio may have an adverse effect on our financial condition.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On November 21, 2007, our board of directors authorized a program to repurchase up to $175.0
million of our common stock to be repurchased at the discretion of management from time to time in
the open market or through privately negotiated transactions. On June 16, 2008, the board of
directors authorized the expansion of this program to $215.0 million. We did not purchase any
shares under this program during the quarter ended September 30, 2011. As of September 30, 2011, we
have purchased a total of 8,866,342 shares under this program at a cost of $114.0 million.
Item 5. Other Information
The Companys policy governing transactions in its securities by its directors, officers and
employees permits its officers, directors and employees to enter into trading plans in accordance
with Rule 10b5-1 under the Exchange Act. During the quarter ended September 30, 2011, Mr. Richard
F. Pops, a director and executive officer of the Company, and Ms. Kathryn L. Biberstein, Mr. James
M. Frates and Mr. Michael J. Landine, each an executive officer of the Company, entered into
trading plans in accordance with Rule 10b5-1, and the Companys policy governing transactions in
its securities by its directors, officers and employees. The Company undertakes no obligation to
update or revise the information provided herein, including for revision or termination of an
established trading plan.
Item 6. Exhibits
(a) List of Exhibits:
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Exhibit |
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No. |
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2.1
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Business Combination Agreement and Plan of Merger, dated as of May 9, 2011, by and among Elan, Alkermes, Inc., Alkermes plc and certain other parties (Incorporated by reference to Annex A to the proxy statement/prospectus forming a part of the Registration
Statement on Form S-4, as amended (Registration No. 333-175078), which was declared effective by the Securities and Exchange
Commission on August 4, 2011).
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3.1
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Amended and Restated Memorandum and Articles of Association of
Alkermes plc (Incorporated by reference to Exhibit 3.1 to our Current Report on Form 8-K filed on
September 16, 2011.) |
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4.1
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Shareholders Agreement by and among Elan, Elan Science Three Limited and Alkermes plc (Incorporated by reference to Exhibit 4.1 to our Current Report on Form 8-K filed on September 16, 2011.)
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10.1
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First Lien Term Loan Credit Agreement, dated as
of September 16, 2011, among Alkermes, Inc., the guarantors party thereto, the lenders party thereto, Morgan
Stanley Senior Funding, Inc. as Administrative Agent and Collateral Agent and the arrangers and agents party thereto
(Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on September 16, 2011.) |
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10.2
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Second Lien Term Loan Credit Agreement, dated as of September 16, 2011, among Alkermes, Inc., the guarantors party thereto, the lenders party thereto, Morgan Stanley Senior Funding, Inc. as Administrative Agent and Collateral Agent and the arrangers and agents party thereto (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed on September 16, 2011.) |
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10.3
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Intellectual Property Transfer Agreement, dated as of September 15, 2011 between
Alkermes, Inc., Alkermes Controlled Therapeutics, Inc. and Alkermes Pharma Holdings Limited (Incorporated by reference
to Exhibit 10.3 to our Current Report on Form 8-K filed on September 16, 2011.) |
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10.4
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Form of Deed of Indemnification for Alkermes plc Officers (Incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.5
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Form of Deed of Indemnification for Alkermes plc Directors/Secretary (Incorporated by reference to Exhibit 10.2 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.6
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Form of Deed of Indemnification for Alkermes Inc. and Subsidiaries Directors/Secretary (Incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.7
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Fiscal 2012 Alkermes plc Affiliated Company Reporting Officer Performance Pay Plan (Incorporated by reference to Exhibit 10.4 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.8
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Shane Cooke Offer Letter, dated as of September 15, 2011 (Incorporated by reference to Exhibit 10.5 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.9
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Employment Agreement by and between Alkermes Pharma Ireland Limited and Shane Cooke, dated as of September 16, 2011 (Incorporated by reference to Exhibit 10.6 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.10
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James L. Botkin Offer Letter, dated as of September 15, 2011 (Incorporated by reference to Exhibit 10.7 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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10.11
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Employment Agreement by and between Alkermes Gainesville LLC and James L. Botkin, dated as of September 16, 2011 (Incorporated by reference to Exhibit 10.8 to our Current Report on Form 8-K filed on September 20, 2011.)+ |
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31.1
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Rule 13a-14(a)/15d-14(a) Certification (filed herewith). |
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31.2
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Rule 13a-14(a)/15d-14(a) Certification (filed herewith). |
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32.1
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Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002 (furnished herewith). |
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101
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The following materials from
Alkermes, plcs Quarterly Report on Form 10-Q for
the quarter ended September 30, 2011, formatted in XBRL (Extensible Business Reporting
Language): (i) the Condensed Consolidated Balance Sheets,
(ii) the Condensed Consolidated Statements of Operations and
Comprehensive loss (iii) Condensed Consolidated Statement of
Shareholder Equity (iv) the Condensed Consolidated
Statements of Cash Flows, and (v) the Notes to the Condensed Consolidated
Financial Statements (furnished herewith). |
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+
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Indicates a management contract or any compensatory plan, contract or arrangement. |
34
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ALKERMES plc
(Registrant)
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By: |
/s/ Richard F. Pops
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Chairman and Chief Executive Officer |
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(Principal Executive Officer) |
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By: |
/s/ James M. Frates
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Senior Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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Date: November 3, 2011
35