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 December 31, 2009
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-14131
ALKERMES, INC.
(Exact name of registrant as specified in its charter)
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PENNSYLVANIA
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23-2472830 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
852 Winter Street, Waltham, MA 02451-1420
(781) 609-6000
(Address, including zip code, and telephone number, including
area code, of registrants principal executive offices)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files): Yes o 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. (Check one):
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act.): Yes o No þ
The number of shares outstanding of each of the issuers classes of common stock was:
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As of February 1, |
Class |
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2010 |
Common Stock, $.01 par value |
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94,440,904 |
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Non-Voting Common Stock, $.01 par value |
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382,632 |
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ALKERMES, INC. AND SUBSIDIARIES
INDEX
2
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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December 31, |
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March 31, |
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2009 |
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2009 |
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(In thousands, except share and per |
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share amounts) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
73,932 |
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$ |
86,893 |
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Investments short-term |
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165,016 |
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236,768 |
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Receivables |
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28,233 |
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24,588 |
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Inventory |
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20,049 |
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20,297 |
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Prepaid expenses and other current assets |
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5,950 |
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7,500 |
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Total current assets |
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293,180 |
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376,046 |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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96,332 |
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106,461 |
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INVESTMENTS LONG-TERM |
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118,531 |
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80,821 |
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OTHER ASSETS |
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11,857 |
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3,158 |
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TOTAL ASSETS |
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$ |
519,900 |
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$ |
566,486 |
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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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$ |
29,560 |
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$ |
36,483 |
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Deferred revenue current |
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2,305 |
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6,840 |
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NON-RECOURSE
RISPERDAL®
CONSTA® SECURED 7% NOTES CURRENT |
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25,667 |
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25,667 |
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Total current liabilities |
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57,532 |
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68,990 |
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NON-RECOURSE RISPERDAL CONSTA SECURED 7% NOTES LONG-TERM |
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31,636 |
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50,221 |
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DEFERRED REVENUE LONG-TERM |
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5,120 |
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5,238 |
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OTHER LONG-TERM LIABILITIES |
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6,386 |
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7,149 |
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Total liabilities |
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100,674 |
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131,598 |
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COMMITMENTS AND CONTINGENCIES (Note 13) |
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SHAREHOLDERS EQUITY: |
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Capital stock, par value, $0.01 per share; 4,550,000 shares authorized (includes
3,000,000 shares of preferred stock); none issued |
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Common stock, par value, $0.01 per share; 160,000,000 shares authorized;
104,354,986 and 104,044,663 shares issued; 94,418,724 and 94,536,212 shares
outstanding at December 31, 2009 and March 31, 2009, respectively |
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1,042 |
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1,040 |
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Non-voting common stock, par value, $0.01 per share; 450,000 shares authorized;
382,632 shares issued and outstanding at December 31, 2009 and March 31, 2009 |
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4 |
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4 |
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Treasury stock, at cost (9,936,262 and 9,508,451 shares at December 31, 2009 and
March 31, 2009, respectively) |
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(129,567 |
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(126,025 |
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Additional paid-in capital |
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903,480 |
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892,415 |
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Accumulated other comprehensive loss |
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(3,980 |
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(6,484 |
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Accumulated deficit |
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(351,753 |
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(326,062 |
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Total shareholders equity |
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419,226 |
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434,888 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
519,900 |
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$ |
566,486 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three Months Ended |
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Nine Months Ended |
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December 31, |
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December 31, |
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2009 |
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2008 |
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2009 |
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2008 |
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(In thousands, except per share amounts) |
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REVENUES: |
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Manufacturing revenues |
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$ |
28,650 |
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$ |
20,533 |
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$ |
90,289 |
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$ |
92,182 |
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Royalty revenues |
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9,970 |
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7,970 |
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27,489 |
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24,990 |
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Product sales, net |
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5,451 |
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14,320 |
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Research and development revenue under collaborative arrangements |
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81 |
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3,736 |
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2,705 |
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40,438 |
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Net collaborative profit |
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123,422 |
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5,002 |
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125,354 |
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Total revenues |
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44,152 |
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155,661 |
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139,805 |
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282,964 |
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EXPENSES: |
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Cost of goods manufactured and sold |
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10,072 |
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5,536 |
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37,830 |
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31,921 |
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Research and development |
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22,577 |
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22,669 |
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68,827 |
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64,640 |
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Selling, general and administrative |
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17,739 |
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14,568 |
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57,632 |
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38,173 |
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Total expenses |
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50,388 |
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42,773 |
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164,289 |
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134,734 |
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OPERATING (LOSS) INCOME |
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(6,236 |
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112,888 |
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(24,484 |
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148,230 |
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OTHER EXPENSE, NET: |
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Interest income |
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1,017 |
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2,574 |
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3,666 |
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8,883 |
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Interest expense |
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(1,423 |
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(2,436 |
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(4,698 |
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(10,905 |
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Other expense, net |
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(160 |
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(641 |
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(290 |
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(1,471 |
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Total other expense, net |
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(566 |
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(503 |
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(1,322 |
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(3,493 |
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(LOSS) INCOME BEFORE INCOME TAXES |
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(6,802 |
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112,385 |
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(25,806 |
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144,737 |
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PROVISION (BENEFIT) FOR INCOME TAXES |
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15 |
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(330 |
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(115 |
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637 |
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NET (LOSS) INCOME |
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$ |
(6,817 |
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$ |
112,715 |
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$ |
(25,691 |
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$ |
144,100 |
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(LOSS) EARNINGS PER COMMON SHARE: |
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Basic |
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$ |
(0.07 |
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$ |
1.18 |
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$ |
(0.27 |
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$ |
1.51 |
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Diluted |
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$ |
(0.07 |
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$ |
1.18 |
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$ |
(0.27 |
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$ |
1.49 |
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
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Basic |
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94,784 |
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95,316 |
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94,815 |
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95,246 |
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Diluted |
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94,784 |
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95,818 |
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94,815 |
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96,398 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Nine Months Ended |
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December 31, |
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2009 |
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2008 |
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(In thousands) |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net (loss) income |
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$ |
(25,691 |
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$ |
144,100 |
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Adjustments to reconcile net (loss) income to cash flows from operating activities: |
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Depreciation |
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20,314 |
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7,501 |
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Share-based compensation expense |
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10,811 |
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11,590 |
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Other non-cash charges |
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3,520 |
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4,531 |
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Loss on the purchase of non-recourse RISPERDAL CONSTA secured 7% notes |
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1,989 |
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Changes in assets and liabilities: |
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Receivables |
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(3,645 |
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11,585 |
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Inventory, prepaid expenses and other assets |
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1,199 |
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(4,746 |
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Accounts payable and accrued expenses |
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(11,199 |
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(4,722 |
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Unearned milestone revenue |
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(117,657 |
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Deferred revenue |
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(4,653 |
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(9,529 |
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Other long-term liabilities |
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(1,369 |
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(1,415 |
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Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal
attributable to original issue discount |
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(1,574 |
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(4,590 |
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Cash flows (used in) provided by operating activities |
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(12,287 |
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38,637 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of property, plant and equipment |
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(9,197 |
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(4,145 |
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Sales of property, plant and equipment |
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249 |
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7,717 |
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Investment in Acceleron Pharmaceuticals, Inc. |
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(8,000 |
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Purchases of investments |
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(390,818 |
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(543,408 |
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Sales and maturities of investments |
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427,270 |
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540,721 |
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Cash flows provided by investing activities |
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19,504 |
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885 |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from the issuance of common stock for share-based compensation
arrangements |
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182 |
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7,606 |
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Excess tax benefit from share-based compensation |
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75 |
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Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal |
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(17,676 |
) |
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Purchase of non-recourse RISPERDAL CONSTA secured 7% notes |
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(67,185 |
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Payment of capital leases |
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(47 |
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Purchase of common stock for treasury |
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(2,684 |
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(17,948 |
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Cash flows used in financing activities |
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(20,178 |
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(77,499 |
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NET DECREASE IN CASH AND CASH EQUIVALENTS |
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(12,961 |
) |
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(37,977 |
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CASH AND CASH EQUIVALENTS Beginning of period |
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86,893 |
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101,241 |
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CASH AND CASH EQUIVALENTS End of period |
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$ |
73,932 |
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$ |
63,264 |
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SUPPLEMENTAL CASH FLOW DISCLOSURE: |
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Cash paid for interest |
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$ |
3,706 |
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$ |
7,663 |
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Cash paid for taxes |
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$ |
53 |
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$ |
435 |
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Non-cash investing and financing activities: |
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Purchased capital expenditures included in accounts payable and accrued expenses |
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$ |
3,933 |
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$ |
1,883 |
|
Receipt of Alkermes shares for the purchase of stock options or to satisfy minimum
tax withholding obligations related to stock based awards |
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$ |
858 |
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$ |
707 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of Alkermes, Inc. (the Company
or Alkermes) for the three and nine months ended December 31, 2009 and 2008 are unaudited and
have been prepared on a basis substantially consistent with the audited financial statements for
the year ended March 31, 2009. 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 (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 Companys audited
consolidated financial statements and notes thereto which are contained in the Companys Annual
Report on Form 10-K for the year ended March 31, 2009, filed with the 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, Inc. and its wholly-owned subsidiaries: Alkermes Controlled Therapeutics,
Inc.; Alkermes Europe, Ltd.; and RC Royalty Sub LLC (Royalty Sub). The assets of Royalty Sub are
not available to satisfy obligations of Alkermes and its subsidiaries, other than the obligations
of Royalty Sub, including Royalty Subs non-recourse RISPERDAL CONSTA secured 7% notes (the
non-recourse 7% Notes), and the assets of Alkermes are not available to satisfy obligations of
Royalty Sub. Intercompany accounts and transactions have been eliminated.
Use of Estimates The preparation of the Companys condensed consolidated financial
statements in conformity with GAAP necessarily requires management to make estimates and
assumptions that affect the following: (1) reported amounts of assets and liabilities; (2)
disclosure of contingent assets and liabilities at the date of the condensed consolidated financial
statements; and (3) the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from these estimates.
Segment Information The Company operates as one business segment, which is the business of
developing, manufacturing and commercializing innovative medicines designed to yield better
therapeutic outcomes and improve the lives of patients with serious diseases. The Companys chief
decision maker, the Chief Executive Officer, reviews the Companys operating results on an
aggregate basis and manages the Companys operations as a single operating unit.
Reclassifications $4.6 million that was previously classified as Purchase of non-recourse
RISPERDAL CONSTA Secured 7% notes for the nine months ended December 31, 2008, was reclassified to
Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal attributable to original issue
discount in the accompanying condensed consolidated statements of cash flows to conform to current
period presentation.
New Accounting Pronouncements
On April 1, 2009, the Company adopted new guidance issued by the Financial Accounting
Standards Board (FASB) on the accounting for collaborative arrangements. The guidance defined
collaborative arrangements and established reporting requirements for transactions between
participants in a collaborative arrangement and between participants in the arrangement and third
parties. The adoption of this standard did not have an impact on the Companys financial position
or results of operations.
6
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On April 1, 2009, the Company adopted new accounting guidance issued by the FASB on fair value
measurements for its nonfinancial assets and liabilities that are subject to measurement at fair
value on a non-recurring basis. The adoption of this standard did not impact the Companys
financial position or results of operations; however, this standard may impact the Company in
subsequent periods and require additional disclosures. Also, effective April 1, 2009, the Company
adopted new accounting guidance issued by the FASB on fair value measurements in determining
whether a market is active or inactive and whether third-party transactions with similar assets and
liabilities are distressed in determining the fair value of its assets and liabilities measured at
fair value on a recurring basis. The adoption of this standard did not impact the Companys
financial position or results of operations.
In June 2009, the FASB issued accounting guidance regarding the accounting for transfers of
financial assets that will improve the relevance, representational faithfulness and comparability
of the information that a reporting entity provides in its financial statements about a transfer of
financial assets, the effects of such a transfer on its financial position, financial performance
and cash flows, and provide information as to a transferors continuing involvement, if any, in
transferred financial assets. The guidance is effective for the Companys fiscal year beginning
April 1, 2010, and the Company does not expect the adoption of this standard to have a significant
impact on its financial position or results of operations.
In June 2009, the FASB issued accounting guidance on business combinations and noncontrolling
interests in consolidated financial statements. The new guidance revises the method of accounting
for a number of aspects of business combinations and noncontrolling interests, including
acquisition costs, contingencies (including contingent assets, contingent liabilities and
contingent purchase price), the impacts of partial and step-acquisitions (including the valuation
of net assets attributable to non-acquired minority interests) and post-acquisition exit activities
of acquired businesses. The guidance is effective for the Companys fiscal year beginning April 1,
2010, and the Company does not expect the adoption of this standard to have a significant impact on
its financial position or results of operations.
In September 2009, the Emerging Issues Task Force (EITF) of the FASB issued accounting
guidance related to revenue recognition that amends the previous guidance on arrangements with
multiple deliverables. This guidance provides principles and application guidance on whether
multiple deliverables exist, how the arrangements should be separated and how the consideration
should be allocated. It also clarifies the method to allocate revenue in an arrangement using the
estimated selling price. This guidance is effective for the Companys fiscal year beginning April
1, 2011, and the Company does not expect the adoption of this standard to have a significant impact
on its financial position or results of operations.
2. COMPREHENSIVE (LOSS) INCOME
Comprehensive (loss) income is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Net (loss) income |
|
$ |
(6,817 |
) |
|
$ |
112,715 |
|
|
$ |
(25,691 |
) |
|
$ |
144,100 |
|
Unrealized gains (losses) on available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Holding gains (losses) |
|
|
650 |
|
|
|
(1,212 |
) |
|
|
2,410 |
|
|
|
(1,478 |
) |
Reclassification of unrealized losses to realized losses
on available-for-sale securities |
|
|
94 |
|
|
|
556 |
|
|
|
94 |
|
|
|
1,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains (losses) on available-for-sale securities |
|
|
744 |
|
|
|
(656 |
) |
|
|
2,504 |
|
|
|
(315 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive (loss) income |
|
$ |
(6,073 |
) |
|
$ |
112,059 |
|
|
$ |
(23,187 |
) |
|
$ |
143,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. EARNINGS PER SHARE
Basic (loss) earnings per common share is calculated based upon net (loss) income available to
holders of common shares divided by the weighted average number of shares outstanding. For the
calculation of diluted earnings per common share, the Company uses the weighted average number of
common shares outstanding, as adjusted for the effect of potential outstanding shares, including
stock options and stock awards.
Basic and diluted (loss) earnings per common share are calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(6,817 |
) |
|
$ |
112,715 |
|
|
$ |
(25,691 |
) |
|
$ |
144,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
94,784 |
|
|
|
95,316 |
|
|
|
94,815 |
|
|
|
95,246 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
446 |
|
|
|
|
|
|
|
974 |
|
Restricted stock units |
|
|
|
|
|
|
56 |
|
|
|
|
|
|
|
178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive common share equivalents |
|
|
|
|
|
|
502 |
|
|
|
|
|
|
|
1,152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted (loss) earnings per share |
|
|
94,784 |
|
|
|
95,818 |
|
|
|
94,815 |
|
|
|
96,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following amounts are not included in the calculation of (loss) earnings per common share
because their effects are anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Stock options |
|
|
17,658 |
|
|
|
16,356 |
|
|
|
17,801 |
|
|
|
15,366 |
|
Restricted stock units |
|
|
538 |
|
|
|
630 |
|
|
|
318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
18,196 |
|
|
|
16,986 |
|
|
|
18,119 |
|
|
|
15,366 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. INVESTMENTS
Investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
|
|
|
|
|
|
(In thousands) |
|
|
|
|
|
December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
$ |
126,980 |
|
|
$ |
202 |
|
|
$ |
|
|
|
$ |
127,182 |
|
International government agency debt securities |
|
|
28,641 |
|
|
|
162 |
|
|
|
|
|
|
|
28,803 |
|
Corporate debt securities |
|
|
6,748 |
|
|
|
|
|
|
|
(99 |
) |
|
|
6,649 |
|
Other debt securities |
|
|
2,501 |
|
|
|
|
|
|
|
(119 |
) |
|
|
2,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
164,870 |
|
|
|
364 |
|
|
|
(218 |
) |
|
|
165,016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
|
61,346 |
|
|
|
|
|
|
|
(340 |
) |
|
|
61,006 |
|
International government agency debt securities |
|
|
851 |
|
|
|
|
|
|
|
(14 |
) |
|
|
837 |
|
Corporate debt securities |
|
|
43,817 |
|
|
|
|
|
|
|
(2,112 |
) |
|
|
41,705 |
|
Other debt securities |
|
|
10,000 |
|
|
|
|
|
|
|
(1,716 |
) |
|
|
8,284 |
|
Strategic investments |
|
|
644 |
|
|
|
198 |
|
|
|
|
|
|
|
842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
116,658 |
|
|
|
198 |
|
|
|
(4,182 |
) |
|
|
112,674 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government obligations |
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
417 |
|
Certificates of deposit |
|
|
5,440 |
|
|
|
|
|
|
|
|
|
|
|
5,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
122,515 |
|
|
|
198 |
|
|
|
(4,182 |
) |
|
|
118,531 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
|
$ |
287,385 |
|
|
$ |
562 |
|
|
$ |
(4,400 |
) |
|
$ |
283,547 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
$ |
225,490 |
|
|
$ |
2,635 |
|
|
$ |
(6 |
) |
|
$ |
228,119 |
|
Corporate debt securities |
|
|
8,160 |
|
|
|
9 |
|
|
|
|
|
|
|
8,169 |
|
Other debt securities |
|
|
500 |
|
|
|
|
|
|
|
(20 |
) |
|
|
480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
234,150 |
|
|
|
2,644 |
|
|
|
(26 |
) |
|
|
236,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
|
10,149 |
|
|
|
|
|
|
|
(3 |
) |
|
|
10,146 |
|
Corporate debt securities |
|
|
57,887 |
|
|
|
|
|
|
|
(6,326 |
) |
|
|
51,561 |
|
Other debt securities |
|
|
16,350 |
|
|
|
|
|
|
|
(2,683 |
) |
|
|
13,667 |
|
Strategic investments |
|
|
738 |
|
|
|
53 |
|
|
|
|
|
|
|
791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
85,124 |
|
|
|
53 |
|
|
|
(9,012 |
) |
|
|
76,165 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government obligations |
|
|
416 |
|
|
|
|
|
|
|
|
|
|
|
416 |
|
Certificates of deposit |
|
|
4,240 |
|
|
|
|
|
|
|
|
|
|
|
4,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
89,780 |
|
|
|
53 |
|
|
|
(9,012 |
) |
|
|
80,821 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
|
$ |
323,930 |
|
|
$ |
2,697 |
|
|
$ |
(9,038 |
) |
|
$ |
317,589 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the nine months ended December 31, 2009, the Company had $427.3 million of proceeds
from the sales and maturities of investments. The proceeds from the sales and maturities of
its investments resulted in realized gains of $0.2 million and realized losses of less than
$0.1 million.
9
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Companys available-for-sale and held-to-maturity securities at December 31, 2009 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 |
|
$ |
72,188 |
|
|
$ |
72,095 |
|
|
$ |
5,857 |
|
|
$ |
5,857 |
|
After 1 year through 5 years (1) |
|
|
149,919 |
|
|
|
149,787 |
|
|
|
|
|
|
|
|
|
After 5 years through 10 years (1) |
|
|
48,777 |
|
|
|
46,682 |
|
|
|
|
|
|
|
|
|
After 10 years |
|
|
10,000 |
|
|
|
8,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
280,884 |
|
|
$ |
276,848 |
|
|
$ |
5,857 |
|
|
$ |
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Investments in available-for-sale securities within these categories,
with an amortized cost of $98.5 million and an estimated fair value of
$96.6 million, have issuer call dates prior to May 2011. |
The Company recognizes other-than-temporary impairments through a charge to earnings if it has
the intent to sell the debt security or if it is more likely than not that it will be required to
sell the debt security before recovery of its amortized cost basis. However, even if the Company
does not expect to sell a debt security, it must evaluate expected cash flows to be received and
determine if a credit loss has occurred. In the event of a credit loss, only the amount associated
with the credit loss is recognized in operating results. The amount of loss relating to other
factors is recorded in accumulated other comprehensive income. An unrealized loss exists when the
current fair value of an individual security is less than its amortized cost basis. Unrealized
losses on available-for-sale securities that are determined to be temporary, and not related to
credit loss, are recorded, net of tax, in accumulated other comprehensive income.
For available-for-sale debt securities with unrealized losses, the Company performs an
analysis to assess whether it intends to sell, or whether it would more likely than not be required
to sell, the security before the expected recovery of the amortized cost basis. If the Company
intends to sell a security, or may be required to do so, the securitys decline in fair value is
deemed to be other-than-temporary and the full amount of the unrealized loss is recorded within
earnings as an impairment loss. Regardless of its intent to sell a security, the Company performs
additional analyses on all securities with unrealized losses to evaluate losses associated with the
creditworthiness of the security. Credit losses are identified when the Company does not expect to
receive cash flows sufficient to recover the amortized cost basis of a security.
For equity securities, when assessing whether a decline in fair value below its cost basis is
other-than-temporary, the Company considers the fair market value of the security, the duration of
the securitys decline and the financial condition of the issuer. The Company then considers its
intent and ability to hold the equity security for a period of time sufficient to recover its
carrying value. If the Company determines that it lacks the intent and ability to hold an equity
security to its expected recovery, the securitys decline in fair value is deemed to be
other-than-temporary and is recorded within operating results as an impairment loss.
Certain of the Companys investments in corporate debt securities with a cost of $2.0 million
consist of investment grade subordinated, medium term, callable step-up floating rate notes (FRN)
issued by the Royal Bank of Scotland Group (RBS). At December 31, 2009, these FRNs had a
composite rating by Moodys, Standard & Poors (S&P) and Fitch of A. During the nine months ended
December 31, 2009, these FRNs had minimal or no trades and because a fair value could not be
derived from quoted prices, the Company used a discounted cash flow model to determine the
estimated fair value of the securities at December 31, 2009. The assumptions used in the discounted
cash flow model included estimates for interest rates, expected holding periods and risk adjusted
discount rates, which the Company believes to be the most critical assumptions utilized within the
analysis. The valuation analysis considered, among other items, assumptions that market
participants would use in their estimates of fair value, such as the creditworthiness and credit
spreads of the issuer and when callability features may be exercised by the issuer. These
securities were also compared, where possible, to securities with observable market data with
similar characteristics to the securities held by the Company. The Company estimated the fair value
of these FRNs to be $1.7 million at December 31, 2009.
In making the determination that the decline in fair value of these FRNs was temporary, the
Company considered various factors, including but not limited to: the length of time each security
was in an unrealized loss
10
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
position; the extent to which fair value was less than cost; the
financial condition and near term prospects of the issuers; and the intent not to sell these
securities and 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 estimated fair value
of these FRNs could change significantly based on future financial market conditions. These FRNs
held by the Company did not trade either because they were nearing their scheduled call dates or
due to abnormally high credit spreads on the debt of the issuers, or both. Similar securities the
Company has held have been called at par by issuers prior to maturity. The Company will continue to
monitor the securities and the financial markets and if there is continued deterioration, the fair
value of these securities could decline further resulting in an other-than-temporary impairment
charge.
The Companys two investments in auction rate securities consist of taxable student loan
revenue bonds issued by the Colorado Student Obligation Bond Authority (Colorado), with a cost of
$5.0 million, and Brazos Higher Education Service Corporation (Brazos), with a cost of $5.0
million, which service student loans under the Federal Family Education Loan Program (FFELP). The
bonds are collateralized by student loans purchased by the authorities, which are guaranteed by
state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity for these
securities is typically provided by an auction process that resets the applicable interest rate at
pre-determined intervals. The Colorado and Brazos securities were rated Aaa and Baa3 by Moodys,
respectively, at December 31, 2009. Due to repeated failed auctions since January 2008, the Company
no longer considers these securities to be liquid and has classified them as long-term investments
in the condensed consolidated balance sheets. The securities continue to pay interest during the
periods in which the auctions have failed.
Since the security auctions have failed and fair value cannot be derived from quoted prices,
the Company used a discounted cash flow model to determine the estimated fair value of the
securities at December 31, 2009. The assumptions used in the discounted cash flow model include
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 valuation analysis considers,
among other items, assumptions that market participants would use in their estimates of fair value,
such as the collateral underlying the security, the creditworthiness of the issuer and any
associated guarantees, the timing of expected future cash flows, the timing of, and the likelihood
that the security will have a successful auction or when callability features may be exercised by
the issuer. These securities were also compared, where possible, to other observable market data
with similar characteristics to the securities held by the Company. The Company estimated the fair
value of the auction rate securities to be $8.3 million at December 31, 2009.
In making the determination that the decline in fair value of the auction rate 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 intent not to sell these
securities and 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 estimated fair value
of the auction rate securities could change significantly based on future financial market
conditions. The Company continues to monitor the securities and the financial markets and if there
is continued deterioration, the fair value of these securities could decline further resulting in
an other-than-temporary impairment charge.
At December 31, 2009, the Companys investments in asset backed debt securities consist of
medium term floating rate notes (MTN) of Aleutian Investments, LLC (Aleutian) and Meridian
Funding Company, LLC (Meridian), which are qualified special purpose entities (QSPEs) of Ambac
Financial Group, Inc. (Ambac) and MBIA, Inc. (MBIA), respectively. Ambac and MBIA are
guarantors of financial obligations and are referred to as monoline financial guarantee insurance
companies. The QSPEs, which purchase pools of assets or securities and fund the purchase through
the issuance of MTNs, have been established to provide a vehicle to access the capital markets for
asset backed debt securities and corporate borrowers. The MTNs include sinking fund redemption
features which match-fund the terms of redemptions to the maturity dates of the underlying pools of
assets or securities in order to mitigate potential liquidity risk to the QSPEs. At December 31,
2009, $7.4 million of the Companys initial $9.9 million investment in MTNs had been redeemed
through scheduled and unscheduled sinking fund redemptions at par value.
11
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The liquidity and fair value of these securities has been negatively impacted by the
uncertainty in the credit markets and the exposure of these securities to the financial condition
of monoline financial guarantee insurance companies, including Ambac and MBIA. At December 31,
2009, Ambac had ratings of Caa2 and CC by Moodys and S&P, respectively, and MBIA had ratings of
Ba3 and BB+ by Moodys and S&P, respectively. Because the MTNs are not actively trading in the
credit markets and fair value cannot be derived from quoted prices, the Company
used a discounted cash flow model to determine the estimated fair value of the securities at
December 31, 2009. The Companys valuation analyses consider, among other items, assumptions that
market participants would use in their estimates of fair value such as the collateral underlying
the security, the creditworthiness of the issuer and the associated guarantees by Ambac and MBIA,
the timing of expected future cash flows, including whether the callability features of these
investments may be exercised by the issuer. These securities were also compared, where possible, to
securities with observable market data with similar characteristics to the securities held by the
Company. The Company believes there are several significant assumptions that are utilized in its
valuation analyses, the most critical of which is the discount rate, which includes a provision for
default and liquidity risk. The Company estimated the fair value of the asset backed securities to
be $2.4 million at December 31, 2009.
The Company may not be able to liquidate its investment in these securities before the
scheduled redemptions or until trading in the securities resumes in the credit markets, which may
not occur. At December 31, 2009, the Company determined that the securities had been temporarily
impaired due to: the length of time each security was in an unrealized loss position; the extent to
which fair value was less than cost; the financial condition and near term prospects of the
issuers; current redemptions made by the issuers; and the intent not to sell these securities and
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 Companys strategic investments include common stock in publicly-traded companies with
which it has or did have a collaborative agreement. For the nine months ended December 31, 2009 and
2008, the Company recognized $0.1 million and $1.2 million, respectively, in charges for
other-than-temporary losses on its strategic investments due to declines in their fair value.
5. FAIR VALUE MEASUREMENTS
The following table presents information about the Companys assets 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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
2009 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Cash equivalents |
|
$ |
91 |
|
|
$ |
91 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
188,188 |
|
|
|
188,188 |
|
|
|
|
|
|
|
|
|
International government agency debt securities |
|
|
29,640 |
|
|
|
29,640 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
48,354 |
|
|
|
|
|
|
|
46,656 |
|
|
|
1,698 |
|
Other debt securities |
|
|
10,666 |
|
|
|
|
|
|
|
|
|
|
|
10,666 |
|
Strategic equity investments |
|
|
842 |
|
|
|
842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
277,781 |
|
|
$ |
218,761 |
|
|
$ |
46,656 |
|
|
$ |
12,364 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
2009 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Cash equivalents |
|
$ |
822 |
|
|
$ |
822 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
238,265 |
|
|
|
238,265 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
59,730 |
|
|
|
|
|
|
|
|
|
|
|
59,730 |
|
Other debt securities |
|
|
14,147 |
|
|
|
|
|
|
|
|
|
|
|
14,147 |
|
Strategic equity investments |
|
|
791 |
|
|
|
791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
313,755 |
|
|
$ |
239,878 |
|
|
$ |
|
|
|
$ |
73,877 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table is a rollforward of the fair value of the Companys investments whose
fair value is determined using Level 3 inputs:
|
|
|
|
|
|
|
Fair |
|
(In thousands) |
|
Value |
|
Balance, March 31, 2009 |
|
$ |
73,877 |
|
Total unrealized gains included in comprehensive loss |
|
|
4,496 |
|
Sales and redemptions, at par value |
|
|
(21,049 |
) |
Transfers out of Level 3 |
|
|
(44,960 |
) |
|
|
|
|
Balance, December 31, 2009 |
|
$ |
12,364 |
|
|
|
|
|
The fair values of the Companys investments in certain of its corporate debt securities and
other debt securities, including auction rate securities and asset backed debt securities, are
determined using certain inputs that are unobservable and considered significant to the overall
fair value measurement. During the nine months ended December 31, 2009, certain of the corporate
debt securities and asset backed debt securities held by the Company had minimal or no trades and
the security auctions for the Companys auction rate securities had failed. The Company is unable
to derive a fair value for these investments using quoted market prices and used discounted cash
flow models as described in Note 4, Investments.
During the three months ended September 30, 2009, trading resumed for certain of the Companys
investments in corporate debt securities and these corporate debt securities, with a fair value of
$33.9 million, were transferred from a Level 3 classification to a Level 2 classification. During
the three months ended December 31, 2009, the Company transferred an additional $11.0 million of
corporate debt securities to a Level 2 classification as trading resumed for these securities. At
December 31, 2009, the Company derived a fair value for its Level 2 investments using market
observable inputs.
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 Companys non-recourse 7% Notes had a
carrying value of $57.3 million and $75.9 million and a fair value of $55.0 million and $74.7
million at December 31, 2009 and March 31, 2009, respectively. The estimated fair value of the
non-recourse 7% Notes was based on a discounted cash flow model.
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:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2009 |
|
|
2009 |
|
Raw materials |
|
$ |
5,169 |
|
|
$ |
5,916 |
|
Work in process |
|
|
6,251 |
|
|
|
5,397 |
|
Finished goods (1) |
|
|
8,381 |
|
|
|
7,015 |
|
Consigned-out inventory (2) |
|
|
248 |
|
|
|
1,969 |
|
|
|
|
|
|
|
|
Inventory |
|
$ |
20,049 |
|
|
$ |
20,297 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
At December 31, 2009 and March 31, 2009, the Company had $1.6 million
and none, respectively, of finished goods inventory located at its
third-party warehouse and shipping service provider. |
|
(2) |
|
At December 31, 2009, consigned-out inventory relates to inventory in
the distribution channel for which the Company has not recognized
revenue. At March 31, 2009, consigned-out inventory consisted of $1.8
million of consigned-out inventory and $0.2 million of inventory in
the distribution channel for which the Company had not recognized
revenue. |
13
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2009 |
|
|
2009 |
|
Land |
|
$ |
301 |
|
|
$ |
301 |
|
Building and improvements |
|
|
36,548 |
|
|
|
36,325 |
|
Furniture, fixture and equipment |
|
|
61,635 |
|
|
|
67,165 |
|
Leasehold improvements |
|
|
33,980 |
|
|
|
33,996 |
|
Construction in progress |
|
|
50,677 |
|
|
|
41,908 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
183,141 |
|
|
|
179,695 |
|
Less: accumulated depreciation |
|
|
(86,809 |
) |
|
|
(73,234 |
) |
|
|
|
|
|
|
|
Total property, plant and equipment, net |
|
$ |
96,332 |
|
|
$ |
106,461 |
|
|
|
|
|
|
|
|
As a result of the Companys relocation of its corporate headquarters from Cambridge,
Massachusetts to Waltham, Massachusetts in January 2010, the Company recorded a charge of $14.8
million to depreciation during the nine months ended December 31, 2009. The depreciation charge
relates to the acceleration of depreciation on laboratory related leasehold improvements located at
the Companys Cambridge facility, which no longer has any benefit or future use to the Company, and
the write-down of laboratory equipment that is no longer in use and will be disposed of.
8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2009 |
|
|
2009 |
|
Accounts payable |
|
$ |
6,140 |
|
|
$ |
8,046 |
|
Accrued compensation |
|
|
11,482 |
|
|
|
13,817 |
|
Accrued interest |
|
|
1,011 |
|
|
|
1,549 |
|
Amounts due to Cephalon |
|
|
|
|
|
|
1,169 |
|
Accrued other |
|
|
10,927 |
|
|
|
11,902 |
|
|
|
|
|
|
|
|
Total accounts payable and accrued expenses |
|
$ |
29,560 |
|
|
$ |
36,483 |
|
|
|
|
|
|
|
|
9. SHARE-BASED COMPENSATION
Share-based compensation expense consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
(In thousands) |
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Cost of goods manufactured and sold |
|
$ |
434 |
|
|
$ |
291 |
|
|
$ |
1,263 |
|
|
$ |
1,148 |
|
Research and development |
|
|
759 |
|
|
|
527 |
|
|
|
2,485 |
|
|
|
3,397 |
|
Selling, general and administrative (1) |
|
|
2,179 |
|
|
|
2,463 |
|
|
|
7,063 |
|
|
|
7,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
3,372 |
|
|
$ |
3,281 |
|
|
$ |
10,811 |
|
|
$ |
11,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
In September 2009, in connection with the resignation of its former
President and Chief Executive Officer, the Company entered into a
separation agreement that provided for, among other things: the
acceleration of vesting of certain stock options and restricted stock
awards that were scheduled to vest through June 30, 2010; and the
period in which vested stock options are exercisable was extended
until the earlier of June 30, 2011 or the stated expiration date of
the stock options. As a result of these stock option and award
modifications, the Company recorded an expense of $0.9 million during
the three months ended September 30, 2009. |
At December 31, 2009 and March 31, 2009, $0.5 million and $0.4 million, respectively, of
share-based compensation expense was capitalized and recorded as Inventory in the condensed
consolidated balance sheets.
14
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. COLLABORATIONS
In December 2009, the Company entered into a collaboration and license agreement with
Acceleron Pharma, Inc. (Acceleron). In exchange for a nonrefundable upfront payment of $2.0
million, an equity investment in Acceleron of $8.0 million and certain potential milestone payments
and royalties, the Company has obtained an exclusive license to Accelerons proprietary long-acting
Fc fusion technology platform, called the MedifusionTM technology, which is designed to
extend the circulating half-life of proteins and peptides. The first drug candidate being developed
with this technology is a long-acting form of a TNF receptor-Fc fusion protein for the treatment of
rheumatoid arthritis and related autoimmune diseases. The Company and Acceleron have agreed to
collaborate on the development of product candidates from the Medifusion technology. Pursuant to
the terms of the agreement, Acceleron will develop up to two selected drug compounds using the
Medifusion technology through preclinical studies, at which point the Company will assume
responsibility for all clinical development and commercialization of these two compounds and any
other compounds the Company elects to develop resulting from the platform. Acceleron will retain
all rights to the technology for products derived from the TGF-beta superfamily.
The Companys $8.0 million investment in Acceleron consists of shares of Series D-1
convertible, redeemable preferred stock, which represents a 3% ownership position in Acceleron. The
Companys Chief Executive Officer has been one of nine members of Accelerons board of directors. The
Company is accounting 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. Accordingly,
the Company does not record any share of Accelerons net income or losses, but would record
dividends, if received. The carrying value of the investment is $8.0 million at December 31, 2009
and is recorded within other assets in the accompanying condensed consolidated balance sheet. The
Company will 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 the investee, market prices of comparable public companies, and general market
conditions.
In addition to the upfront payment and equity investment, the Company will reimburse Acceleron
for any time, at an agreed-upon full-time equivalent (FTE) rate, and materials Acceleron incurs
during development. The Company is obligated to make developmental and
sales milestone payments in the aggregate of up to $110.0 million per
product in the event that certain development and
sales goals are achieved. The Company is also obligated to make
tiered royalty payments in the mid-single digits on annual net sales
in the event any products developed under the agreement are
commercialized.
During the three months ended December 31, 2009, the Company incurred expenses of $0.1 million
in connection with its arrangement with Acceleron, which is recorded within research and
development expense in the accompanying condensed consolidated statement of operations.
Additionally, the $2.0 million upfront payment was charged to research and development expense as
technological feasibility of the acquired technology has not been established.
11. RESTRUCTURING
In connection with the 2008 restructuring program in which the Company and Eli Lilly and
Company announced the decision to discontinue the AIR® Insulin development program (the
2008 Restructuring), the Company recorded charges of $6.9 million during the year ended March 31,
2008. Activity related to the 2008 Restructuring in the nine months ended December 31, 2009 was as
follows:
|
|
|
|
|
(In thousands) |
|
Balance |
|
Accrued restructuring, March 31, 2009 |
|
$ |
4,193 |
|
Payments for facility closure costs |
|
|
(611 |
) |
Other adjustments |
|
|
158 |
|
|
|
|
|
Accrued Restructuring, December 31, 2009 |
|
$ |
3,740 |
|
|
|
|
|
At December 31, 2009 and March 31, 2009, the restructuring liability related to the 2008
Restructuring consists of $0.6 million classified as current, and $3.1 million and $3.5 million
classified as long-term, respectively, in the accompanying condensed consolidated balance sheets.
As of December 31, 2009, the Company has paid in cash, written off, recovered and made
restructuring charge adjustments totaling approximately $0.2 million in facility closure costs,
$2.9 million in employee separation costs and $0.1 million in other contract termination costs in
connection with the 2008 Restructuring. The $3.7 million remaining in the restructuring accrual at
December 31, 2009 is expected to be paid out through fiscal year 2016 and relates primarily to
future lease costs associated with an exited facility.
15
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. INCOME TAXES
The Company records a deferred tax asset or liability based on the difference between the
financial statement and tax bases of assets and liabilities, as measured by enacted tax rates
assumed to be in effect when these differences reverse. At December 31, 2009, the Company
determined that it is more likely than not that the deferred tax assets may not be realized and a
full valuation allowance continues to be recorded.
The Company had an income tax provision of less than $0.1 million and an income tax benefit of
$0.1 million during the three and nine months ended December 31, 2009, respectively. This income
tax provision and benefit for the three and nine months ended December 31, 2009, respectively,
primarily represents the amount the Company estimates it will benefit from the Housing and Economic
Recovery Act of 2008. This legislation allows for certain taxpayers to forego bonus depreciation in
lieu of a refundable cash credit based on certain qualified asset purchases. The income tax benefit
of $0.3 million and provision of $0.6 million for the three and nine months ended December 31,
2008, respectively, is related to the U.S. alternative minimum tax (AMT). The utilization of tax
loss carryforwards is limited in the calculation of AMT and, as a result, a federal tax benefit and
charge were recorded in the three and nine months ended December 31, 2008, respectively. The AMT
liability is available as a credit against future tax obligations upon the full utilization or
expiration of the Companys net operating loss carryforward and research and development credits.
13. COMMITMENTS AND CONTINGENCIES
From time to time, the Company may be subject to legal proceedings and claims in the ordinary
course of business. The Company is not aware of any such proceedings or claims that it believes
will have, individually or in the aggregate, a material adverse effect on its business, financial
condition or results of operations.
In April 2009, the Company entered into a lease agreement in connection with the relocation of
its corporate headquarters from Cambridge, Massachusetts to Waltham, Massachusetts, which began in
January 2010. The initial lease term, which began in December 2009, is for 10 years with provisions
for the Company to extend the lease term up to an additional 10 years. In June 2009, the Company
executed an amendment to the lease agreement which increased the square footage leased by the
Company by approximately 15%. The total rent expense related to the new headquarters is
approximately $3.1 million annually during the initial lease term.
In April 2009, the Company entered into an agreement to sublease a portion of its Cambridge,
Massachusetts headquarters. Under the terms of the agreement, the Company exited and made available
certain of its Cambridge, Massachusetts facility to the leasee on August 1, 2009 and recorded a
charge of $1.0 million, which equals the amount of rent expense in excess of estimated sublease
income associated with the vacated space the Company expects to collect through the remainder of
the lease term.
14. SUBSEQUENT EVENTS
The Company has evaluated events occurring subsequent to December 31, 2009 through February 4,
2010, which is the date the Companys financial statements were issued. The Company does not have
any recognized or nonrecognized subsequent events to disclose.
16
|
|
|
Item 2. |
|
Managements Discussion and Analysis of Financial Condition and Results of Operations |
Alkermes, Inc. (as used in this section, together with our subsidiaries, us, we, our or
the Company) is a fully integrated biotechnology company committed to developing innovative
medicines to improve patients lives. We developed, manufacture and commercialize
VIVITROL® for alcohol dependence and manufacture RISPERDAL®
CONSTA® for schizophrenia and bipolar disorder. Our robust pipeline includes
extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic
diseases, such as central nervous system disorders, addiction and diabetes. We have research
facilities in Massachusetts and a commercial manufacturing facility in Ohio. In January 2010, we
relocated our corporate headquarters from Cambridge, Massachusetts, to Waltham, Massachusetts.
Forward-Looking Statements
Any statements herein or otherwise made in writing or orally by us with regard to our
expectations as to financial results and other aspects of our business may constitute
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to our future plans, objectives, expectations and intentions and may
be identified by words like believe, expect, designed, may, will, should, seek, or
anticipate, and similar expressions. These forward looking statements may include, but are not
limited to, statements concerning: the achievement of certain business and operating goals and
future operating results and profitability; manufacturing revenues; product sales and royalty
revenues; spending relating to research and development, manufacturing, and selling and marketing
activities; financial goals and projections of capital expenditures; recognition of revenues;
future financings; continued growth of RISPERDAL CONSTA sales; the commercialization of VIVITROL in
the United States (U.S.) by us and in Russia and the Commonwealth of Independent States (CIS)
by Cilag GmbH International (Cilag), a subsidiary of Johnson & Johnson; recognition of milestone
payments from Cilag related to the future sales of VIVITROL in Russia and the CIS; the successful
continuation of development activities for our programs, including exenatide once weekly, VIVITROL
for opioid dependence (including our plans to file a supplemental NDA (sNDA) for VIVITROL for the
treatment of opioid dependence), ALKS 29, ALKS 33, ALKS 36 and ALKS 37, ALKS 6931, ALKS 9070; the
expectation and timeline for regulatory approval of the New Drug Application (NDA) submission for
exenatide once weekly; the patentability of our new chemistry-based LinkeRxTM technology
platform; and the successful manufacture of our products and product candidates, including
RISPERDAL CONSTA, VIVITROL and polymer for exenatide once weekly, by us at a commercial scale, and
the successful manufacture of exenatide once weekly by Amylin Pharmaceuticals, Inc. (Amylin).
Although we believe that our expectations are based on reasonable assumptions within the
bounds of our knowledge of our business and operations, the forward-looking statements contained in
this document are neither promises nor guarantees. Our business is subject to significant risk and
uncertainties and there can be no assurance that our actual results will not differ materially from
our expectations. Factors which could cause actual results to differ materially from our
expectations set forth in our forward-looking statements are set forth in the section entitled
Risk Factors in our Annual Report on Form 10-K for the year ended March 31, 2009 and subsequent
Quarterly Reports on Form 10-Q, and include, among others: (i) manufacturing and royalty revenues
from RISPERDAL CONSTA may not continue to grow, particularly because we rely on our partner,
Janssen Pharmaceutica, Inc., a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Janssen
Pharmaceutica International, a division of Cilag International (together Janssen), to forecast
and market this product and because our partner markets and sells INVEGA® SUSTENNA, a
competing product; (ii) we may be unable to manufacture RISPERDAL CONSTA, VIVITROL and polymer for
exenatide once weekly, in sufficient quantities and with sufficient yields to meet our or our
partners requirements or to add additional production capacity for RISPERDAL CONSTA and VIVITROL,
or unexpected events could interrupt manufacturing operations at our RISPERDAL CONSTA and VIVITROL
manufacturing facility, which is the sole source of supply for these products; (iii) we may be
unable to develop the commercial capabilities, and/or infrastructure, necessary to successfully
commercialize VIVITROL; (iv) Cilag may be unable to receive approval for VIVITROL for the treatment
of opioid dependence in Russia and for the treatment of alcohol and opioid dependence in the CIS;
(v) Cilag may be unable to successfully commercialize VIVITROL in Russia and the CIS; (vi) third
party payors may not cover or reimburse us for purchases of our products; (vii) if approved, Eli
Lilly and Company (Lilly) and Amylin may be unable to successfully commercialize exenatide once
weekly; (viii) we may be unable to scale-up and manufacture our product candidates commercially or
economically; (ix) we may not be able to source raw
17
materials for our production processes from third parties; (x) Amylin may not be able to
successfully operate the manufacturing facility for exenatide once weekly and the U.S. Food and
Drug Administration (FDA) may not find the product produced in the Amylin facility comparable to
the product used in the pivotal clinical study which was manufactured in our facility; (xi) our
product candidates, if approved for marketing, may not be launched successfully in one or all
indications for which marketing is approved and, if launched, may not produce significant revenues;
(xii) we rely on our partners to determine the regulatory and marketing strategies for RISPERDAL
CONSTA and our other partnered, non-proprietary programs; (xiii) RISPERDAL CONSTA, VIVITROL and, if
approved, exenatide once weekly, may have unintended side effects, adverse reactions or incidents
of misuse and the FDA or other health authorities could require post approval studies or the
removal of our products from the market; (xiv) our collaborators could elect to terminate or delay
programs at any time and disputes with collaborators or failure to negotiate acceptable new
collaborative arrangements for our technologies could occur; (xv) clinical trials may take more
time or consume more resources than initially envisioned; (xvi) results of earlier clinical trials
may not necessarily be predictive of the safety and efficacy results in larger clinical trials, and
the results of clinical trials may not be predictive of the safety or efficacy results of the
product in commercial use; (xvii) our product candidates could be ineffective or unsafe during
preclinical studies and clinical trials, and we and our collaborators may not be permitted by
regulatory authorities to undertake new or additional clinical trials for product candidates
incorporating our technologies, or clinical trials could be delayed or terminated; (xviii) after
the completion of clinical trials for our product candidates, including exenatide once weekly, or
after the submission for marketing approval of such product candidates, the FDA or other health
authorities could refuse to accept such filings, could request additional preclinical or clinical
studies be conducted or request a safety monitoring program, any of which could result in
significant delays or the failure of such products to receive marketing approval; (xix) even if our
product candidates appear promising at an early stage of development, product candidates could fail
to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be
uneconomical, fail to achieve market acceptance, be precluded from commercialization by proprietary
rights of third parties or experience substantial competition in the marketplace; (xx)
technological change in the biotechnology or pharmaceutical industries could render our products
and/or product candidates obsolete or non-competitive; (xxi) difficulties or set-backs in obtaining
and enforcing our patents, including but not limited to those related to our LinkeRx technology
platform, and difficulties with the patent rights of others could occur; (xxii) we may incur losses
in the future; (xxiii) we may need to raise substantial additional funding to continue research and
development programs and clinical trials and other operations and could incur difficulties or
setbacks in raising such funds, which may be further impacted by current economic conditions and
the lack of available credit sources; (xxiv) our methodology for determining the fair value of our
investments may change; and (xxv) we may not be able to liquidate or otherwise recoup our
investments in corporate debt securities, asset backed debt securities and auction rate securities.
The forward-looking statements made in this document are made only as of the date hereof and
we do not intend to update any of these factors or to publicly announce the results of any
revisions to any of our forward-looking statements other than as required under the federal
securities laws.
Our Strategy
We leverage our formulation expertise and drug development technologies to develop, both with
partners and on our own, innovative and competitively advantaged drug products 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 technologies. In addition, we apply our innovative formulation
expertise and drug development capabilities to create our own new, proprietary pharmaceutical
products. Each of these approaches is discussed in more detail in Products and Development
Programs.
Products and Development Programs
RISPERDAL CONSTA
RISPERDAL CONSTA is a long-acting formulation of risperidone, a product of Janssen, and is the
first and only long-acting, atypical antipsychotic approved by the FDA for both the treatment of
both schizophrenia and bipolar I disorder. The medication uses our proprietary Medisorb®
technology to deliver and maintain therapeutic medication levels in the body through just one
injection every two weeks. RISPERDAL CONSTA is marketed by
18
Janssen and is exclusively manufactured by us. RISPERDAL CONSTA was first approved by
regulatory authorities in the United Kingdom and Germany in August 2002 and by the FDA in October
2003. RISPERDAL CONSTA is approved for the treatment of schizophrenia in approximately 85 countries
and marketed in approximately 60 countries, and Janssen continues to launch the product around the
world. In the U.S., RISPERDAL CONSTA is also approved for the treatment of bipolar I disorder.
Schizophrenia is a brain disorder characterized by disorganized thinking, delusions and
hallucinations. Studies have demonstrated that as many as 75 percent of patients with schizophrenia
have difficulty taking their oral medication on a regular basis, which can lead to worsening of
symptoms. Clinical data have shown that treatment with RISPERDAL CONSTA may lead to improvements in
symptoms, sustained remission and decreases in hospitalization in patients with schizophrenia.
Bipolar disorder is a brain disorder that causes unusual shifts in a persons mood, energy and
ability to function. It is often characterized by debilitating mood swings, from extreme highs
(mania) to extreme lows (depression). Bipolar I disorder is characterized based on the occurrence
of at least one manic episode, with or without the occurrence of a major depressive episode.
Clinical data have shown that RISPERDAL CONSTA significantly delayed the time to relapse compared
to placebo treatment in patients with bipolar disorder.
In August 2009, we received notification from Ortho-McNeil-Janssen Pharmaceuticals, Inc. and
Janssen Pharmaceutica International, a division of Cilag International AG, that based on a
portfolio review, it has decided not to pursue further development of the four-week long-acting
injectable formulation of risperidone.
VIVITROL
We developed VIVITROL, an extended-release Medisorb formulation of naltrexone, which is the
first and only once-monthly injectable medication for the treatment of alcohol dependence. Alcohol
dependence is a serious and chronic brain disease characterized by cravings for alcohol, loss of
control over drinking, withdrawal symptoms and an increased tolerance for alcohol. Adherence to
medication is particularly challenging with this patient population. In clinical trials, when used
in combination with psychosocial support, VIVITROL was shown to reduce the number of drinking days
and heavy drinking days and to prolong abstinence in patients who abstained from alcohol the week
prior to starting treatment. VIVITROL was approved by the FDA in April 2006 and was launched in
June 2006. In December, 2008, we assumed sole responsibility for the commercialization of VIVITROL
in the U.S.. In December 2007, we exclusively licensed the right to commercialize
VIVITROL for the treatment of alcohol and opioid dependence in Russia and other countries in the
CIS to Cilag. In August 2008, the Russian regulatory authorities approved VIVITROL for the
treatment of alcohol dependence. Cilag launched VIVITROL in Russia in March 2009.
We are also developing VIVITROL for the treatment of opioid dependence, a serious and chronic
brain disease characterized by compulsive, prolonged-self administration of opioid substances that
are not used for a medical purpose. In November 2009, we announced positive preliminary results
from a phase 3 clinical trial of VIVITROL for the treatment of opioid dependence. The six-month
phase 3 study met its primary efficacy endpoint, and all secondary endpoints, and data showed that
patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of
clean (opioid-free) urine screens, compared to patients treated with placebo. Based on the positive
results of this phase 3 study, we plan to file a supplemental New Drug Application (sNDA) with the
FDA in the first half of calendar year 2010.
Exenatide Once Weekly
We are collaborating with Amylin on the development of exenatide once weekly for the treatment
of type 2 diabetes. Exenatide once weekly is an injectable formulation of Amylins
BYETTA® (exenatide). BYETTA is an injection administered twice daily. Diabetes is a
disease in which the body does not produce or properly use insulin. Diabetes can result in serious
health complications, including cardiovascular, kidney and nerve disease. BYETTA was approved by
the FDA in April 2005 as adjunctive therapy to improve blood sugar control in patients with type 2
diabetes who have not achieved adequate control on metformin and/or a sulfonylurea, which are
commonly used oral diabetes medications. In December 2006, the FDA approved BYETTA as an add-on
therapy for people with type 2 diabetes unable to achieve adequate glucose control on
thiazolidinediones, a class of diabetes medications. Amylin has an agreement with Lilly for the
development and commercialization of exenatide, including exenatide
19
once weekly. Exenatide once weekly is being developed with the goal of providing patients with
an effective and more patient-friendly treatment option.
In May 2009, Amylin submitted a NDA to the FDA for the treatment of type 2 diabetes. The FDA
accepted the submission in July 2009.
In July 2009, Amylin, Lilly and we announced positive results from the DURATION-3 study
designed to compare exenatide once weekly to LANTUS® (insulin glargine) in 467 patients
with type 2 diabetes taking stable doses of metformin alone or in combination with a sulfonylurea.
Patients randomized to exenatide once weekly experienced a statistically superior reduction in A1C,
a measure of average blood sugar over three months, of 1.5 percentage points from baseline,
compared to a reduction of 1.3 percentage points for LANTUS after completing 26 weeks of treatment.
At the end of the study, patients treated with exenatide once weekly achieved a mean A1C of 6.8
percent compared with a mean A1C of 7.0 percent in those treated with LANTUS. Treatment with
exenatide once weekly also produced a statistically significant difference in weight, with a mean
weight loss of 5.8 pounds at 26 weeks, compared with a mean weight gain of 3.1 pounds for LANTUS, a
difference of 8.9 pounds between the treatments. In addition, patients treated with exenatide once
weekly reported significantly fewer episodes of confirmed hypoglycemia than those patients treated
with LANTUS.
In October 2009, the FDA approved BYETTA as a stand-alone medication (monotherapy) along with
diet and exercise to improve glycemic control in adults with type 2 diabetes.
In December 2009, Amylin, Lilly and we announced positive results from the DURATION-5 study
designed to compare exenatide once weekly to BYETTA in patients with type 2 diabetes who were not
achieving adequate glucose control using background therapies that included diet and exercise,
metformin, sulfonylurea, thiazolidinediones or a combination of the agents. Patients randomized to
exenatide once weekly experienced a statistically superior reduction in A1C, a measure of average
blood sugar over three months, of 1.6 percentage points from baseline, compared to a reduction of
0.9 percentage points for BYETTA after completing 24 weeks of treatment. At the end of the study,
patients treated with exenatide once weekly achieved a mean A1C of 7.1 percent compared with a mean
A1C of 7.7 percent in those treated with BYETTA. Both treatment groups achieved statistically
significant weight loss by the end of the study, with an average loss of 5.1 pounds for patients
taking exenatide once weekly and 3.0 pounds for patients taking BYETTA. Additional studies designed
to demonstrate the superiority of exenatide once weekly compared to commonly prescribed diabetes
medications are ongoing.
ALKS 37
We are developing ALKS 37, an oral, peripherally-restricted opioid antagonist for the
treatment of opioid-induced constipation. Research indicates that a high percentage of patients
receiving opioids are likely to experience side effects affecting gastrointestinal motility. There
are currently no available oral treatments for this condition, which has severe quality of life
implications. In October 2009, we initiated a phase 1 study of ALKS 37 in approximately 40 healthy
volunteers. The randomized, double-blind, placebo-controlled study will assess the safety,
tolerability, pharmacokinetic and pharmacologic effects of a single oral administration of five
doses of ALKS 37. We expect to report topline results from the study in the first half of calendar
2010. ALKS 37 is a component of ALKS 36.
ALKS 36
ALKS 36, a co-formulation of an opioid analgesic and an oral, peripherally-restricted opioid
antagonist, is being developed for the treatment of pain without the side effects of constipation.
Research indicates that a high percentage of patients receiving opioids are likely to experience
side effects affecting gastrointestinal motility. A pain medication that does not inhibit
gastrointestinal motility, such as ALKS 36, could provide an advantage over current therapies.
ALKS 33
ALKS 33 is an oral opioid modulator for the potential treatment of addiction and other central
nervous system disorders. In October 2009, we announced positive topline data from two clinical
trials of ALKS 33. Data from the
20
studies, ALK33-003 and ALK33-004, showed that ALKS 33 was generally well tolerated and
successfully blocked the effects of an opioid with a duration of action that supports once daily
dosing. ALK33-003 was a phase 1 randomized, double-blind, placebo-controlled, multi-dose study
designed to assess the steady-state pharmacokinetics, safety and tolerability of ALKS 33 in 30
healthy subjects. ALK33-004 was a phase 1, randomized, single-blind, placebo-controlled,
single-dose study designed to test the ability of ALKS 33 to block the subjective and objective
effects of a potent opioid agonist, remifentanil (a commercially available analgesic) in 24
healthy, non-dependent, opioid-experienced subjects. In November 2009, we announced the initiation
of a phase 2 clinical study to assess the safety and efficacy of multiple doses of ALKS 33 in
patients with alcohol dependence and to further define the clinical profile of ALKS 33.
ALKS 29
We are developing ALKS 29, an oral combination therapy for the treatment of alcohol
dependence. ALKS 29 is a co-formulation of ALKS 33, a proprietary opioid modulator, and baclofen,
an FDA-approved muscle relaxant and antispasmodic therapeutic. Research suggests that baclofen may
attenuate the compulsive component of alcohol dependence. As a co-formulation of ALKS 33 and
baclofen, ALKS 29 is designed to address both the compulsive and impulsive components of alcohol
dependence.
ALKS 6931
ALKS 6931 is a long-acting form of a TNF receptor-FC fusion protein for the treatment of
rheumatoid arthritis and related autoimmune diseases. ALKS 6931 is our first candidate being
developed using the MedifusionTM technology licensed from Acceleron Pharmaceuticals, Inc.
(Acceleron). ALKS 6931 is structurally similar to etanercept, commercially available under the
name ENBREL®.
ALKS 9070
ALKS 9070 is a once-monthly, injectable, sustained-release version of aripiprazole for the
treatment of schizophrenia. ALKS 9070 is our first candidate to leverage our proprietary
LinkeRxTM technology platform. Aripiprazole is commercially available under the name
ABILIFY® for the treatment of a number of CNS disorders. Based on encouraging
preclinical results, ALKS 9070 is expected to enter the clinic in the second half of calendar 2010.
Executive Summary
Net loss for the three months ended December 31, 2009 was $6.8 million, or $0.07 per common
share basic and diluted, as compared to net income of $112.7 million, or $1.18 per common share
basic and diluted, for the three months ended December 31, 2008. Net loss for the nine months
ended December 31, 2009 was $25.7 million or $0.27 per common share basic and diluted, as
compared to net income of $144.1 million, or $1.51 per common share basic and $1.49 per common
share diluted, for the nine months ended December 31, 2008. Net loss for the three and nine
months ended December 31, 2009 includes $3.6 million and $15.9 million, respectively, in charges
associated with the relocation of our corporate headquarters from Cambridge, Massachusetts to
Waltham, Massachusetts.
Results of Operations
Manufacturing Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Manufacturing revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
27.2 |
|
|
$ |
21.3 |
|
|
$ |
5.9 |
|
|
$ |
87.0 |
|
|
$ |
88.0 |
|
|
$ |
(1.0 |
) |
Polymer |
|
|
1.5 |
|
|
|
|
|
|
|
1.5 |
|
|
|
2.9 |
|
|
|
|
|
|
|
2.9 |
|
VIVITROL |
|
|
|
|
|
|
(0.8 |
) |
|
|
0.8 |
|
|
|
0.4 |
|
|
|
4.2 |
|
|
|
(3.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing revenues |
|
$ |
28.7 |
|
|
$ |
20.5 |
|
|
$ |
8.2 |
|
|
$ |
90.3 |
|
|
$ |
92.2 |
|
|
$ |
(1.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in RISPERDAL CONSTA manufacturing revenues for the three months ended December
31, 2009,
21
as compared to the three months ended December 31, 2008, was primarily due to an 8%
increase in the number of units shipped to Janssen and an increase in the net unit sales price. The
decrease in RISPERDAL CONSTA manufacturing revenues for the nine months ended December 31, 2009, as
compared to the nine months ended December 31, 2008, was primarily due to a decrease in the net
unit sales price, partially offset by an increase in the number of units shipped to Janssen of less
than 1%. The increase in the net unit sales price in the three months ended December 31, 2009, as
compared to the three months ended December 31, 2008, was primarily due to a weaker U.S. dollar in
relation to the foreign currencies in which the product was sold. The decrease in the net unit
sales price in the nine months ended December 31, 2009, as compared to the nine months ended
December 31, 2008, was primarily due to a stronger U.S. dollar in relation to the foreign
currencies in which the product was sold. 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.
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 nine months ended December 31,
2009 and 2008, our RISPERDAL CONSTA manufacturing revenues were based on an average of 7.5% of
Janssens unit net sales price of RISPERDAL CONSTA. We anticipate that we will 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, 2010 and beyond.
Polymer manufacturing revenues for the three and nine months ended December 31, 2009 consist
of polymer sales to Amylin for use in the formulation of exenatide once weekly. We record
manufacturing revenues under our arrangement with Amylin for polymer sales at an agreed upon price
when product is shipped to them. During the three and nine months ended December 31, 2008, we did
not make any shipments of polymer to Amylin.
We record VIVITROL manufacturing revenues under our arrangement with Cilag at an agreed upon
price when product is shipped to them. We made no shipments during the three months ended December
31, 2009 or 2008. VIVITROL manufacturing revenues for the nine months ended December 31, 2009
consisted entirely of product shipments to Cilag for resale in Russia. During the nine months ended
December 31, 2008, we had $0.4 million of billings to Cilag for shipments of VIVITROL to support
the commercialization of VIVITROL in Russia.
Effective December 1, 2008 (the Termination Date), we ended our collaboration with Cephalon
and assumed full responsibility for the marketing and sale of VIVITROL in the U.S., and assumed
title to certain VIVITROL inventory which we had previously sold to Cephalon prior to the
termination. In the three months ended December 31, 2008, we reduced VIVITROL manufacturing
revenues by $0.8 million to reverse the previous sale of this inventory to Cephalon. VIVITROL
manufacturing revenues for the nine months ended December 31, 2008 consisted of $2.8 million of
billings to Cephalon for failed product batches, $0.7 million of net shipments of VIVITROL to
Cephalon and $0.3 million related to manufacturing profit on VIVITROL, which equaled a 10% markup
on VIVITROL cost of goods manufactured, all of which occurred prior to the termination of the
VIVITROL collaboration.
Royalty Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Royalty revenues |
|
$ |
10.0 |
|
|
$ |
8.0 |
|
|
$ |
2.0 |
|
|
$ |
27.5 |
|
|
$ |
25.0 |
|
|
$ |
2.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Substantially all of our royalty revenues for the three and nine months ended December 31,
2009 and 2008 were related to sales of RISPERDAL CONSTA. 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. RISPERDAL CONSTA royalty revenues for the three and nine
months ended December 31, 2009 were based on
RISPERDAL CONSTA sales of $398.7 million and $1,099.1 million, respectively. Royalty revenues
for the three and nine months ended December 31, 2008 were based on RISPERDAL CONSTA sales of
$318.8 million and $999.5 million, respectively. During the three and nine months ended December
31, 2009, 67% and 64% of RISPERDAL CONSTA sales occurred in foreign countries, respectively, as
compared to 63% and 64% during the three and nine months ended December 31, 2008, respectively.
22
Product Sales, net
Upon termination of the VIVITROL collaboration with Cephalon, we assumed the risks and
responsibilities for the marketing and sale of VIVITROL in the U.S., effective on the Termination
Date. The following table presents the adjustments deducted from VIVITROL product sales, gross to
arrive at VIVITROL product sales, net during the three and nine months ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31 |
|
|
December 31 |
|
(In millions) |
|
2009 |
|
|
% of Sales |
|
|
2009 |
|
|
% of Sales |
|
Product sales, gross |
|
$ |
7.2 |
|
|
|
100.0 |
% |
|
$ |
17.7 |
|
|
|
100.0 |
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chargebacks |
|
|
(0.4 |
) |
|
|
(5.6 |
)% |
|
|
(0.7 |
) |
|
|
(4.0 |
)% |
Wholesaler fees |
|
|
(0.3 |
) |
|
|
(4.2 |
)% |
|
|
(0.7 |
) |
|
|
(4.0 |
)% |
Medicaid rebates |
|
|
(0.3 |
) |
|
|
(4.2 |
)% |
|
|
(0.6 |
) |
|
|
(3.4 |
)% |
Product returns (1) |
|
|
(0.4 |
) |
|
|
(5.6 |
)% |
|
|
(0.5 |
) |
|
|
(2.8 |
)% |
Other |
|
|
(0.3 |
) |
|
|
(4.2 |
)% |
|
|
(0.9 |
) |
|
|
(5.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
(1.7 |
) |
|
|
(23.8 |
)% |
|
|
(3.4 |
) |
|
|
(19.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
5.5 |
|
|
|
76.2 |
% |
|
$ |
14.3 |
|
|
|
80.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Following the introduction of a return policy for VIVITROL, our
estimate for product returns 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. |
We began selling VIVITROL in the U.S. on December 1, 2008 and had gross sales during the month
of December of $1.6 million, but no net sales primarily due to the deferral of $1.4 million of
revenue as none of the product sold was estimated to have left the distribution channel. Net sales
of VIVITROL by Cephalon during the three and nine months ended December 31, 2008 were $2.8 million
and $11.0 million, respectively.
Research and Development Revenue Under Collaborative Arrangements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Research and development programs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Four-week RISPERDAL CONSTA |
|
$ |
|
|
|
$ |
1.6 |
|
|
$ |
(1.6 |
) |
|
$ |
2.0 |
|
|
$ |
3.5 |
|
|
$ |
(1.5 |
) |
Exenatide once weekly |
|
|
|
|
|
|
1.5 |
|
|
|
(1.5 |
) |
|
|
0.4 |
|
|
|
9.3 |
|
|
|
(8.9 |
) |
AIR Insulin |
|
|
|
|
|
|
0.1 |
|
|
|
(0.1 |
) |
|
|
|
|
|
|
26.8 |
|
|
|
(26.8 |
) |
Other |
|
|
0.1 |
|
|
|
0.5 |
|
|
|
(0.4 |
) |
|
|
0.3 |
|
|
|
0.8 |
|
|
|
(0.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue under
collaborative arrangements |
|
$ |
0.1 |
|
|
$ |
3.7 |
|
|
$ |
(3.6 |
) |
|
$ |
2.7 |
|
|
$ |
40.4 |
|
|
$ |
(37.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In August 2009, we announced that Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen
Pharmaceutica International, a division of Cilag International AG, decided not to pursue further
development of the four-week formulation of RISPERDAL CONSTA for the treatment of schizophrenia.
Accordingly, we do not expect to recognize revenue from this development program in the future. The
NDA for exenatide once weekly was filed with the FDA in May 2009 and, as a result, revenues under
the program decreased in the three and nine months ended December 31, 2009, as compared to the
three and nine months ended December 31, 2008. The decrease in revenue from the AIR Insulin program
in the three and nine months ended December 31, 2009, as compared to the three and nine months
ended December 31, 2008, was due to the termination of the AIR Insulin development program in March
2008.
23
Net Collaborative Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Net collabortive profit: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Milestone revenue license |
|
$ |
|
|
|
$ |
0.8 |
|
|
$ |
(0.8 |
) |
|
$ |
|
|
|
$ |
3.5 |
|
|
$ |
(3.5 |
) |
Net payments from Cephalon |
|
|
|
|
|
|
0.7 |
|
|
|
(0.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
VIVITROL losses funded by Cephalon,
post termination |
|
|
|
|
|
|
1.2 |
|
|
|
(1.2 |
) |
|
|
5.0 |
|
|
|
1.2 |
|
|
|
3.8 |
|
Recognition of deferred and unearned milestone
revenue due to
termination of
VIVITROL collaboration |
|
|
|
|
|
|
120.7 |
|
|
|
(120.7 |
) |
|
|
|
|
|
|
120.7 |
|
|
|
(120.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net collaborative profit |
|
$ |
|
|
|
$ |
123.4 |
|
|
$ |
(123.4 |
) |
|
$ |
5.0 |
|
|
$ |
125.4 |
|
|
$ |
(120.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net collaborative profit for the nine months ended December 31, 2009 consisted of revenue
earned as a result of the $11.0 million payment we received from Cephalon to fund its share of
estimated VIVITROL losses during the one-year period following the Termination Date. We recorded
the $11.0 million payment as deferred revenue and recognized it as revenue through the application
of a proportional performance model based on VIVITROL losses. This deferred revenue was completely
recognized as of July 31, 2009, and we do not expect to recognize any further net collaborative
profit. Net collaborative profit during the three and nine months ended December 31, 2008 consisted
primarily of $120.7 million of unearned milestone and deferred revenue that existed at the
Termination Date, which was recognized in the three months ended December 31, 2008, as we had no
remaining performance obligations to Cephalon and the amounts were nonrefundable.
Cost of Goods Manufactured and Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Cost of goods manufactured and sold: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
8.4 |
|
|
$ |
5.0 |
|
|
$ |
(3.4 |
) |
|
$ |
30.2 |
|
|
$ |
24.0 |
|
|
$ |
(6.2 |
) |
VIVITROL |
|
|
1.1 |
|
|
|
0.5 |
|
|
|
(0.6 |
) |
|
|
5.7 |
|
|
|
7.9 |
|
|
|
2.2 |
|
Polymer |
|
|
0.6 |
|
|
|
|
|
|
|
(0.6 |
) |
|
|
1.9 |
|
|
|
|
|
|
|
(1.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods manufactured and sold |
|
$ |
10.1 |
|
|
$ |
5.5 |
|
|
$ |
(4.6 |
) |
|
$ |
37.8 |
|
|
$ |
31.9 |
|
|
$ |
(5.9 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in cost of goods manufactured for RISPERDAL CONSTA in the three months ended
December 31, 2009, as compared to the three months ended December 31, 2008, was due to a 8%
increase in the number of units of RISPERDAL CONSTA shipped to Janssen, an increase in costs for
failed batches and an increase in overhead
and support costs allocated to cost of goods manufactured from research and development
(R&D) expense as a result of increasing the focus on
manufacturing activities, as compared to
development activities, at our Ohio manufacturing facility. The increase in cost of goods
manufactured for RISPERDAL CONSTA in the nine months ended December 31, 2009, as compared to the
nine months ended December 31, 2008, was primarily due to the increase in overhead and support
costs allocated to cost of goods manufactured for the reason previously discussed and an increase
in costs for failed product batches.
The increase in cost of goods manufactured and sold for VIVITROL in the three months ended
December 31, 2009, as compared to the three months ended December 31, 2008, was primarily due to an
increase in the number of units sold during the period. During the three months ended December 31,
2008, we did not ship any VIVITROL to Cephalon or Cilag, and we purchased product back from Cephalon
resulting in a reversal of prior sales in connection with the termination of the VIVITROL
collaboration with Cephalon. The decrease in cost of goods manufactured and sold for VIVITROL in
the nine months ended December 31, 2009, as compared to the nine months ended December 31, 2008, was
primarily due to a decrease in the costs related to the restart of the manufacturing line following
a scheduled shutdown of the line and reduced costs for failed batches, partially offset by an
increase in the number of units sold during the period.
During the three and nine months ended December 31, 2008, we did not make any shipments of
polymer to Amylin.
24
Research and Development Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Research and development |
|
$ |
22.6 |
|
|
$ |
22.7 |
|
|
$ |
0.1 |
|
|
$ |
68.8 |
|
|
$ |
64.6 |
|
|
$ |
(4.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D expenses in the three months ended December 31, 2009 were comparable to the R&D expenses
in the three months ended December 31, 2008. During the three months ended December 31, 2009, we
recorded $3.5 million of costs related to the relocation of our corporate headquarters from
Cambridge, Massachusetts, to Waltham, Massachusetts, consisting primarily of the acceleration of
depreciation on laboratory related leasehold improvements located at our Cambridge facility, which
no longer have any benefit or use to us once we exit the Cambridge facility, and the write-down of
laboratory equipment that is no longer in use and will be disposed of. In addition, we incurred
$2.1 million of R&D expense related to the collaboration and license agreement we signed with
Acceleron, in December 2009. These expenses were offset by a decrease in occupancy costs due to the
consolidation of space at our Cambridge, Massachusetts facility, as well as a decrease in overhead
and support costs allocated to R&D at our Ohio manufacturing facility, as discussed above.
The increase in R&D expenses in the nine months ended December 31, 2009, as compared to the
nine months ended December 31, 2008, was primarily due to $15.6 million of costs we incurred as a
result of the relocation of our corporate headquarters, an increase in clinical and pre-clinical
study expense resulting from an increase in the number of ongoing studies, and $2.1 million of
expense related to the collaboration and license agreement we signed with Acceleron in December
2009. These expenses were partially offset by a decrease in overhead and support costs allocated to
R&D at our Ohio manufacturing facility, a decrease in labor and benefits due to a reduction in R&D
headcount and a decrease in occupancy costs due to the consolidation of space at our Cambridge,
Massachusetts facility.
A significant portion of our research and development 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 are reimbursed to us by our partners. We generally bill our partners under
collaborative arrangements using a negotiated FTE or hourly rate. This rate has been established by
us based on our annual budget of employee compensation, employee benefits and the billable
non-project-specific costs mentioned
above and is generally increased annually based on increases in the consumer price index. Each
collaborative partner is billed using a negotiated FTE or hourly rate for the hours worked by our
employees on a particular project, plus direct external costs, if any. 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 |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Selling, general and administrative |
|
$ |
17.7 |
|
|
$ |
14.6 |
|
|
$ |
(3.1 |
) |
|
$ |
57.6 |
|
|
$ |
38.2 |
|
|
$ |
(19.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in selling, general and administrative (SG&A) expense for the three months
ended December 31, 2009, as compared to the three months ended December 31, 2008, was primarily due
to increased sales and marketing costs as we became responsible for the commercialization of
VIVITROL in the U.S. beginning December 1, 2008. The increase in SG&A for the nine months ended
December 31, 2009, as compared to the nine months ended December 31, 2008, was primarily due to
increased sales and marketing costs related to VIVITROL and severance costs we recorded in
connection with the resignation of our former President and Chief Executive Officer in September
2009.
25
Other Expense, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Interest income |
|
$ |
1.0 |
|
|
$ |
2.6 |
|
|
$ |
(1.6 |
) |
|
$ |
3.7 |
|
|
$ |
8.9 |
|
|
$ |
(5.2 |
) |
Interest expense |
|
|
(1.4 |
) |
|
|
(2.4 |
) |
|
|
1.0 |
|
|
|
(4.7 |
) |
|
|
(10.9 |
) |
|
|
6.2 |
|
Other expense, net |
|
|
(0.2 |
) |
|
|
(0.7 |
) |
|
|
0.5 |
|
|
|
(0.3 |
) |
|
|
(1.5 |
) |
|
|
1.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expense, net |
|
$ |
(0.6 |
) |
|
$ |
(0.5 |
) |
|
$ |
(0.1 |
) |
|
$ |
(1.3 |
) |
|
$ |
(3.5 |
) |
|
$ |
2.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in interest income for the three and nine months ended December 31, 2009, as
compared to the three and nine months ended December 31, 2008, was due to a lower average balance
of cash and investments as well as lower interest rates earned. The decrease in interest expense
for the three and nine months ended December 31, 2009, as compared to the three and nine months
ended December 31, 2008, was the result of our repurchase of an aggregate total of $93.0 million
principal amount, or approximately 55%, of our non-recourse RISPERDAL CONSTA secured 7% Notes (the
non-recourse 7% Notes), in five separately negotiated transactions during the year ended March
31, 2009. In addition, we began making quarterly scheduled principal payments on our non-recourse
7% Notes, beginning in April 2009, which reduced interest expense in the three and nine months
ended December 31, 2009. The decrease in other expense, net, for the three and nine months ended
December 31, 2009, as compared to the three and nine months ended December 31, 2008, was due to
decreases in other-than-temporary impairment charges taken on our investments in the common stock
of certain publicly held companies.
Provision for Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change |
|
|
Nine Months Ended |
|
|
Change |
|
|
|
December 31 |
|
|
Favorable/ |
|
|
December 31 |
|
|
Favorable/ |
|
(In millions) |
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
|
2009 |
|
|
2008 |
|
|
(Unfavorable) |
|
Provision (benefit) for income taxes |
|
$ |
|
|
|
$ |
(0.3 |
) |
|
$ |
(0.3 |
) |
|
$ |
(0.1 |
) |
|
$ |
0.6 |
|
|
$ |
(0.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
income tax benefit of $0.1 million for the nine months ended December 31, 2009 consists primarily
of the amount we expect to benefit from the Housing and Economic Recovery Act of 2008.
This legislation allows for certain taxpayers to forego bonus depreciation in lieu of a refundable
cash credit based on certain qualified asset purchases. The income tax benefit of $0.3 million and
the income tax provision of $0.6 million for the three and nine
months ended December 31, 2008, respectively, is related to the U.S. alternative minimum tax
(AMT). The utilization of tax loss carryforwards is limited in the calculation of AMT and, as a
result, a federal tax benefit and charge was recorded in the three and nine months ended December
31, 2008, respectively. The AMT liability is available as a credit against future tax obligations
upon the full utilization or expiration of our net operating loss carryforward.
Liquidity and Capital Resources
We have funded our operations primarily with funds generated by our business operations and
through public offerings and private placements of debt and equity securities, bank loans, term
loans, equipment financing arrangements and payments received under research and development
agreements and other agreements with collaborators. We expect to incur significant additional
research and development and other costs as we expand the development of our proprietary product
candidates, including costs related to preclinical studies and clinical trials. Our costs,
including research and development costs for our product candidates, manufacturing, and sales,
marketing and promotional expenses for any current or future products marketed by us or our
collaborators, if any, may exceed revenues in the future, which may result in losses from
operations. In addition, we have an ongoing share repurchase plan and have repurchased a portion of
our outstanding debt and may continue with some or all of these activities in the future. We
believe that our current cash and cash equivalents and short and long-term investments, combined
with anticipated interest income and anticipated revenues, will generate sufficient cash flows to
meet our anticipated liquidity and capital requirements for the foreseeable future.
26
Our financial condition is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In millions) |
|
2009 |
|
|
2009 |
|
Cash and cash equivalents |
|
$ |
73.9 |
|
|
$ |
86.9 |
|
Investments short-term |
|
|
165.0 |
|
|
|
236.8 |
|
Investments long-term |
|
|
118.6 |
|
|
|
80.8 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents and investments |
|
$ |
357.5 |
|
|
$ |
404.5 |
|
|
|
|
|
|
|
|
Working capital |
|
$ |
235.6 |
|
|
$ |
307.1 |
|
Outstanding borrowings current and long-term |
|
$ |
57.3 |
|
|
$ |
75.9 |
|
Cash and Cash Equivalents
Our cash flows for the nine months ended December 31, 2009 and 2008 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31 |
|
(In millions) |
|
2009 |
|
|
2008 |
|
Cash and cash equivalents, beginning of period |
|
$ |
86.9 |
|
|
$ |
101.2 |
|
Cash (used in) provided by operating activities |
|
|
(12.3 |
) |
|
|
38.6 |
|
Cash provided by investing activities |
|
|
19.5 |
|
|
|
0.9 |
|
Cash used in financing activities |
|
|
(20.2 |
) |
|
|
(77.4 |
) |
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
73.9 |
|
|
$ |
63.3 |
|
|
|
|
|
|
|
|
Operating Activities
The primary reason for the change in cash (used in) provided by our operating activities
during the nine months ended December 31, 2009, as compared to December 31, 2008, is the $40.0
million payment we received from Lilly during the nine months ended December 31, 2008 related to
the termination of the AIR insulin development
program and a net reduction in working capital accounts.
Investing Activities
The increase in cash provided by our investing activities in the nine months ended December
31, 2009, as compared to the nine months ended December 31, 2008, is primarily due an increase in
cash from sales and maturities of investments, net of investment purchases, partially offset by an
increase in fixed asset purchases made during the period in connection with the relocation of our
corporate headquarters from Cambridge, Massachusetts to Waltham,
Massachusetts, and the purchase of
$8.0 million of preferred stock of Acceleron in connection with our
collaboration and license
agreement. Also, during the nine months ended December 31, 2008, we received $7.7 million from the
sale of equipment, as compared to $0.3 million from the sale of equipment during the nine months
ended December 31, 2009.
Financing Activities
The decrease in cash used in financing activities during the nine months ended December 31,
2009, as compared to the nine months ended December 31, 2008, is
primarily due to us not
purchasing our non-recourse 7% Notes during the nine months ended December 31, 2009; we purchased
$15.3 million less common stock for treasury; and we received $7.4 million less in cash from the
exercise of employee stock options, partially offset by the $17.7 million of scheduled principal
payments we made on our non-recourse 7% Notes during the nine months ended December 31, 2009.
Investments
We invest our cash reserves in bank deposits, certificates of deposit, commercial paper,
corporate notes, U.S. and foreign government instruments and other interest bearing marketable debt
instruments in accordance with our
27
investment policy. The primary objective of our investment
policy is the preservation of capital with a secondary objective of generating income on our
investments. 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.
As explained in Note 4, Investments and Note 5, Fair Value Measurements, in the Notes to
Condensed Consolidated Financial Statements, 4% of our investments, which are reported at fair
value on a recurring basis, are valued using unobservable, or Level 3, inputs to determine fair
value. These investments are valued using discounted cash flow models, which use several inputs to
determine fair value, including estimates for interest rates, the timing of cash flows, expected
holding periods and risk adjusted discount rates, which include provisions for default and
liquidity risk. We validate the fair values, when possible, by comparing the fair values to other
observable market data with similar characteristics to the securities held by us. While we believe
the valuation methodologies are appropriate, the use of valuation methodologies is highly
judgmental and changes in methodologies can have a material impact on the values of these assets,
our financial position and overall liquidity.
During the three months ended September 30, 2009, trading resumed for certain of the Companys
investments in corporate debt securities, with a fair value of $33.9 million, and those corporate
debt securities were transferred from a Level 3 classification to a Level 2 classification. During
the three months ended December 31, 2009, we transferred an additional $11.0 million of corporate
debt securities to a Level 2 classification as trading resumed for these securities. At December
31, 2009, we derived a fair value for our Level 2 investments using market observable inputs.
Borrowings
At December 31, 2009, our borrowings consisted of $57.7 million principal amount of our
non-recourse 7% Notes, which have a carrying value of $57.3 million. Principal and interest
payments on the non-recourse 7% Notes are due quarterly, and the non-recourse 7% Notes are
scheduled to be paid in full on January 1, 2012.
Contractual Obligations
In April 2009, we entered into a lease agreement in connection with the relocation of our
corporate headquarters from Cambridge, Massachusetts to Waltham, Massachusetts, which began in
January 2010. The initial lease term, which began in December 2009, is for 10 years with provisions
for us to extend the lease term up to an additional 10 years. In June 2009, we executed an
amendment to the lease agreement which increased the square footage leased by us by approximately
15%. Operating expenses and rent will commence for the additional space in September 2010 and
September 2011, respectively, and the lease amendment has the same termination date as the original
lease. The total rent expense related to the new headquarters is approximately $3.1 million
annually during the initial lease term.
In December 2009, we and Acceleron entered into a license agreement granting us exclusive
rights to Accelerons proprietary long-acting Fc fusion technology platform, called the
MedifusionTM technology, which is designed to extend the circulating half-life of
proteins and peptides. We and Acceleron agreed to collaborate on the development of product
candidates from the Medifusion technology. We paid Acceleron a nonrefundable upfront payment of
$2.0 million and are obligated to reimburse Acceleron for any time, at an agreed-upon FTE rate, and
materials Acceleron incurs during development. We are obligated to make developmental and
sales milestone payments in the aggregate of up to $110.0 million per
product in the event that certain development and
sales goals are achieved. We are also obligated to make
tiered royalty payments in the mid-single digits on annual net sales
in the event any products developed under the agreement are
commercialized.
There are no other material changes to the contractual cash obligations as disclosed in our
Annual Report on Form 10-K for the year ended March 31, 2009.
Off-Balance Sheet Arrangements
At December 31, 2009, we were not a party to any off-balance sheet arrangements.
28
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 accounting principles
generally accepted in the United States of America (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 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 our Annual Report on Form 10-K for the year ended March 31, 2009 in the Critical
Accounting Estimates section for a discussion of our critical accounting estimates.
On April 1, 2009, we adopted new accounting guidance on the recognition and presentation of
other-than-temporary impairments and enhanced our process for reviewing debt securities with
unrealized losses for possible impairment to include a determination as to if we have the intent to
sell a debt security or if it is more likely than not that we would be required to sell the
security before recovery of its amortized cost basis. Also, an other-than-temporary impairment
shall be considered to have occurred if we do not expect to recover the entire amortized cost basis
of a security, regardless of our intent to hold the security to maturity. This enhancement to our
impairment assessment process did not have a material impact on our financial position or results
of operations.
New Accounting Standards
Refer to New Accounting Pronouncements included in Note 1, Summary of Significant Accounting
Policies, in the Notes to Condensed Consolidated Financial Statements for a discussion of new
accounting standards.
|
|
|
Item 3. |
|
Quantitative and Qualitative Disclosures about Market Risk |
Our market risks, and the ways we manage them, are summarized in Part II, Item 7A,
Quantitative and Qualitative Disclosures About Market Risk of our Annual Report on Form 10-K for
the year ended March 31, 2009. In response to the instability in the global financial markets, we
have regularly reviewed our marketable securities holdings and shifted our investment holdings to
those deemed to have reduced risk. Apart from such adjustments to our investment portfolio, there
have been no material changes in the first nine months of fiscal year
2010 to our market risks, 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.
We are exposed to foreign currency exchange risk related to manufacturing and royalty revenues
we receive on RISPERDAL CONSTA as summarized in Part II, Item 7A, Quantitative and Qualitative
Disclosures About Market Risk of our Annual Report on Form 10-K for the year ended March 31, 2009.
There has been no material change in our assessment of our sensitivity to foreign currency exchange
rate risk during the first nine months of fiscal year 2010.
|
|
|
Item 4. |
|
Controls and Procedures |
a) Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation, under the supervision and the participation of our
management, including our principal executive officer and principal financial officer, of 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, or the Securities Exchange
Act) at December 31, 2009. Based upon that evaluation, our principal executive officer and
principal financial officer concluded that, at December 31, 2009, our disclosure controls and
procedures are effective in providing reasonable assurance that (a) the information required to be
disclosed by us in the reports that we file or submit under the Securities Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the SEC rules and
forms, and (b) such information is accumulated and communicated to our management, including our
principal executive officer and principal 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.
29
b) Change in Internal Control over Financial Reporting
During the period covered by this report, there have been no changes in our internal control
over financial reporting that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
30
PART II OTHER INFORMATION
|
|
|
Item 1. |
|
Legal Proceedings |
From time to time, we may be subject to legal proceedings and claims in the ordinary course of
business. We are not aware of any such proceedings or claims that we believe will have,
individually or in the aggregate, a material adverse effect on our business, results of operations
and financial condition.
|
|
|
Item 2. |
|
Unregistered Sales of Equity Securities and Use of Proceeds |
We did not repurchase any of our stock during the three months ended December 31, 2009. On
November 21, 2007, we publicly announced that 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, we publicly announced that our board of directors authorized the expansion of this
repurchase program by an additional $40.0 million, bringing the total authorization under this
program to $215.0 million. The repurchase program has no set expiration date and may be suspended
or discontinued at any time. At December 31, 2009, we had purchased a total of 8,866,342 shares
under this program at a cost of $114.0 million.
During the three months ended December 31, 2009 we acquired, by means of net share
settlements, 16,318 shares of Alkermes common stock at an average price of $8.36 per share related
to the vesting of employee stock awards to satisfy withholding tax obligations.
|
|
|
Item 4. |
|
Submission of Matters to a Vote of Security Holders |
We held our annual meeting of shareholders on October 6, 2009. The following proposals were
voted upon at the meeting:
1. |
|
A proposal to elect ten members of the Board of Directors, each to serve until the next
annual meeting of shareholders and until his or her successor is duly elected and qualified,
was approved with the following vote: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Authority |
Nominee |
|
Votes For |
|
Withheld |
David W. Anstice |
|
|
89,865,836 |
|
|
|
743,471 |
|
Floyd E. Bloom |
|
|
87,931,665 |
|
|
|
2,677,642 |
|
Robert A. Breyer |
|
|
88,071,529 |
|
|
|
2,537,778 |
|
David A. Broecker |
|
|
85,071,790 |
|
|
|
5,537,517 |
|
Geraldine Henwood |
|
|
88,720,730 |
|
|
|
1,888,577 |
|
Paul J. Mitchell |
|
|
88,705,326 |
|
|
|
1,903,981 |
|
Richard F. Pops |
|
|
87,184,289 |
|
|
|
3,425,018 |
|
Alexander Rich |
|
|
88,004,480 |
|
|
|
2,604,827 |
|
Mark B. Skaletsky |
|
|
89,890,957 |
|
|
|
718,350 |
|
Michael A. Wall |
|
|
87,712,797 |
|
|
|
2,896,510 |
|
On September 10, 2009, subsequent to the mailing of our proxy statement but before the annual
meeting of the shareholders, David A. Broecker resigned from our Board of Directors and declined to
stand for reelection as previously disclosed on our Current Report on Form 8-K filed with the SEC
on September 11, 2009.
2. |
|
A proposal to ratify PricewaterhouseCoopers LLP as our independent registered public
accountants for fiscal 2010 was approved with 88,785,709 votes for, 1,748,293 votes against
and 75,305 abstentions. |
|
|
|
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 three months ended December 31, 2009, Mr. Floyd
E. Bloom, a director of the Company, entered
31
into a trading plan 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.
32
(a) List of Exhibits:
|
|
|
Exhibit |
|
|
No. |
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(furnished herewith). |
33
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.
|
|
|
|
|
|
ALKERMES, INC.
(Registrant)
|
|
|
By: |
/s/ Richard F. Pops
|
|
|
|
Richard F. Pops |
|
|
|
Chairman, President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ James M. Frates
|
|
|
|
James M. Frates |
|
|
|
Senior Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
|
|
Date: February 4, 2010
34
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No. |
|
|
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(furnished herewith). |
35