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, 2010
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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
(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 þ No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of large accelerated filer, accelerated filer and smaller reporting
company in Rule 12b-2 of the
Exchange Act. (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 |
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January 31, |
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Class |
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2011 |
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Common Stock, $0.01 par value |
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95,340,250 |
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Non-Voting Common Stock, $0.01 par value |
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382,632 |
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ALKERMES, INC. AND SUBSIDIARIES
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2010
INDEX
2
PART I. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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December 31, |
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March 31, |
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2010 |
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2010 |
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(In thousands, except share and per |
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share amounts) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
38,862 |
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$ |
79,324 |
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Investments short-term |
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138,523 |
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202,053 |
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Receivables |
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24,169 |
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25,316 |
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Inventory |
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19,169 |
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20,653 |
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Prepaid expenses and other current assets |
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11,897 |
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10,936 |
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Total current assets |
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232,620 |
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338,282 |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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96,219 |
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96,905 |
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INVESTMENTS LONG-TERM |
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107,628 |
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68,816 |
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OTHER ASSETS |
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10,970 |
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11,597 |
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TOTAL ASSETS |
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$ |
447,437 |
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$ |
515,600 |
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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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$ |
35,065 |
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$ |
37,881 |
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Deferred revenue current |
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3,360 |
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2,220 |
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Non-Recourse RISPERDAL® CONSTA® Secured 7% Notes Current |
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51,043 |
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Total current liabilities |
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38,425 |
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91,144 |
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DEFERRED REVENUE LONG-TERM |
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4,972 |
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5,105 |
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OTHER LONG-TERM LIABILITIES |
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7,722 |
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6,735 |
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Total liabilities |
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51,119 |
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102,984 |
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COMMITMENTS AND CONTINGENCIES (Note 13) |
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SHAREHOLDERS EQUITY: |
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Common stock, par value, $0.01 per share; 160,000,000 shares authorized;
105,395,641 and 104,815,328 shares issued; 95,328,826 and
94,870,063 shares
outstanding at December 31, 2010 and March 31, 2010, respectively |
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1,051 |
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1,047 |
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Non-voting common stock, par value, $0.01 per share; 450,000 shares authorized;
382,632 shares issued and outstanding at December 31, 2010 and
March 31, 2010 |
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4 |
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4 |
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Treasury stock, at cost (10,066,815 and 9,945,265 shares at December 31, 2010 and
March 31, 2010, respectively) |
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(131,065 |
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(129,681 |
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Additional paid-in capital |
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927,435 |
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910,326 |
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Accumulated other comprehensive loss |
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(2,961 |
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(3,392 |
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Accumulated deficit |
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(398,146 |
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(365,688 |
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Total shareholders equity |
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396,318 |
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412,616 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
447,437 |
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$ |
515,600 |
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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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2010 |
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2009 |
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2010 |
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2009 |
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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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$ |
26,155 |
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$ |
28,650 |
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$ |
86,209 |
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$ |
90,289 |
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Royalty revenues |
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9,777 |
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9,970 |
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28,154 |
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27,489 |
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Product sales, net |
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7,729 |
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5,451 |
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20,402 |
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14,320 |
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Research and development revenue under
collaborative arrangements |
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314 |
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81 |
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737 |
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2,705 |
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Net collaborative profit |
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5,002 |
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Total revenues |
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43,975 |
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44,152 |
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135,502 |
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139,805 |
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EXPENSES: |
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Cost of goods manufactured and sold |
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12,860 |
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10,072 |
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39,436 |
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37,830 |
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Research and development |
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22,503 |
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22,577 |
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69,412 |
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68,827 |
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Selling, general and administrative |
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20,521 |
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17,739 |
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58,683 |
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57,632 |
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Total expenses |
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55,884 |
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50,388 |
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167,531 |
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164,289 |
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OPERATING LOSS |
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(11,909 |
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(6,236 |
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(32,029 |
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(24,484 |
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OTHER INCOME (EXPENSE), NET: |
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Interest income |
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650 |
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1,017 |
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2,175 |
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3,666 |
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Interest expense |
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(1,423 |
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(3,298 |
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(4,698 |
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Other expense, net |
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(83 |
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(160 |
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(266 |
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(290 |
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Total other income (expense), net |
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567 |
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(566 |
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(1,389 |
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(1,322 |
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LOSS BEFORE INCOME TAXES |
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(11,342 |
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(6,802 |
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(33,418 |
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(25,806 |
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INCOME TAX PROVISION (BENEFIT) |
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41 |
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15 |
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(960 |
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(115 |
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NET LOSS |
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$ |
(11,383 |
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$ |
(6,817 |
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$ |
(32,458 |
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$ |
(25,691 |
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LOSS PER COMMON SHARE: |
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Basic and diluted |
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$ |
(0.12 |
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$ |
(0.07 |
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$ |
(0.34 |
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$ |
(0.27 |
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING: |
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Basic and diluted |
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95,667 |
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94,784 |
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95,502 |
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94,815 |
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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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2010 |
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2009 |
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(In thousands) |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
(32,458 |
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$ |
(25,691 |
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Adjustments to reconcile net loss to cash flows from operating activities: |
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Depreciation |
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6,210 |
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20,314 |
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Share-based compensation expense |
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15,196 |
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10,811 |
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Other non-cash charges |
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2,273 |
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3,520 |
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Changes in assets and liabilities: |
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Receivables |
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1,147 |
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(3,645 |
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Inventory, prepaid expenses and other assets |
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4,059 |
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1,199 |
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Accounts payable and accrued expenses |
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(4,928 |
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(11,199 |
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Deferred revenue |
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1,007 |
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(4,653 |
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Other long-term liabilities |
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(75 |
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(1,369 |
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Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal
attributable to original issue discount |
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(6,611 |
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(1,574 |
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Cash flows used in operating activities |
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(14,180 |
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(12,287 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of property, plant and equipment |
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(8,029 |
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(9,197 |
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Sales of property, plant and equipment |
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260 |
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249 |
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Investment in Acceleron Pharmaceuticals, Inc. |
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(501 |
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(8,000 |
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Purchases of investments |
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(324,143 |
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(390,818 |
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Sales and maturities of investments |
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349,546 |
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427,270 |
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Cash flows provided by investing activities |
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17,133 |
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19,504 |
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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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1,982 |
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182 |
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Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal |
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(45,397 |
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(17,676 |
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Purchase of common stock for treasury |
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(2,684 |
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Cash flows used in financing activities |
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(43,415 |
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(20,178 |
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NET DECREASE IN CASH AND CASH EQUIVALENTS |
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(40,462 |
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(12,961 |
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CASH AND CASH EQUIVALENTS Beginning of period |
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79,324 |
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86,893 |
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CASH AND CASH EQUIVALENTS End of period |
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$ |
38,862 |
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$ |
73,932 |
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SUPPLEMENTAL CASH FLOW DISCLOSURE: |
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Cash paid for interest |
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$ |
1,684 |
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$ |
3,706 |
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Cash paid for taxes |
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$ |
22 |
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$ |
53 |
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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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$ |
550 |
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$ |
3,933 |
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Investment in Civitas Therapeutics, Inc. |
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$ |
1,320 |
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$ |
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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
Alkermes, Inc. (the Company or Alkermes) is a fully integrated biotechnology company
committed to developing innovative medicines to improve patients lives. The Company developed,
manufactures and commercializes VIVITROL® for alcohol dependence and for the prevention
of relapse to opioid dependence, following opioid detoxification. The Company also manufactures
RISPERDAL® CONSTA® for schizophrenia and bipolar I disorder. The Companys
pipeline includes extended-release injectable and oral products for the treatment of prevalent,
chronic diseases, such as central nervous system (CNS) disorders, reward disorders, addiction,
diabetes and autoimmune disorders. The Company is headquartered in Waltham, Massachusetts and has a
research facility in Massachusetts and a commercial manufacturing facility in Ohio.
The accompanying condensed consolidated financial statements of Alkermes for the three and
nine months ended December 31, 2010 and 2009 are unaudited and have been prepared on a basis
substantially consistent with the audited financial statements for the fiscal year ended March 31,
2010. The year-end condensed consolidated balance sheet data was derived from audited financial
statements, but does not include all disclosures required by accounting principles generally
accepted in the United States of America (U.S.) (commonly referred to as GAAP). In the opinion
of management, the condensed consolidated financial statements include all adjustments, which are
of a normal recurring nature, that are necessary to present fairly the results of operations for
the reported periods.
These financial statements should be read in conjunction with the 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, 2010, 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). 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 Chairman, President and Chief Executive Officer, reviews the Companys
operating results on an aggregate basis and manages the Companys operations as a single operating
unit.
6
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
New Accounting Pronouncements
In September 2009, the Emerging Issues Task Force (EITF) of the Financial Accounting
Standards Board (FASB) issued accounting guidance related to revenue recognition that amends the
previous guidance on arrangements with multiple deliverables. The new guidance provides accounting
principles and application guidance on whether multiple deliverables exist, how the arrangement
should be separated, and provides for separate revenue recognition based upon managements estimate
of the selling price for an undelivered item when there is no other means to determine the fair
value of that undelivered item. Accounting guidance previously required that the fair value of the
undelivered item be the price of the item either sold in a separate transaction between unrelated
third parties or the price charged for each item when the item is sold separately by the vendor.
This was difficult to determine when the product was not individually sold because of its unique
features. Under the previous guidance, if the fair value of all of the elements in the arrangement
was not determinable, then revenue was deferred until all of the items were delivered or fair value
was determined. This guidance is effective prospectively for revenue arrangements entered into or
materially modified in the Companys fiscal year beginning April 1, 2011, and the Company is
currently evaluating the potential impact of this standard on its consolidated financial
statements. Early adoption is permitted, however, adoption of this guidance as of a date other than
April 1, 2011 will require the Company to apply this guidance retrospectively effective as of April
1, 2010, and will require disclosure of the effect of this guidance as applied to all previously
reported interim periods in the fiscal year of adoption. The Company has decided it will not adopt
this standard prior to the effective date of April 1, 2011.
In January 2010, the FASB issued accounting guidance related to fair value measurements that
requires additional disclosure related to transfers in and out of Levels 1 and 2 of the fair value
hierarchy. The guidance also requires additional disclosure for activity within Level 3 of the fair
value hierarchy. The guidance requires a reporting entity to disclose separately the amounts of
significant transfers in and out of Level 1 and Level 2 and describe the reasons for the transfers.
In addition, this guidance requires a reporting entity to present information separately about
purchases, sales issuances and settlements in the reconciliation for fair value measurements using
significant unobservable inputs, or Level 3 inputs. This accounting standard was effective for
interim and annual reporting periods beginning after December 31, 2009, other than for disclosures
about purchases, sales, issuances and settlements in the rollforward of activity in Level 3 fair
value measurements. Those disclosures are effective for fiscal years beginning after December 31,
2010 and for interim periods within those fiscal years. The Company adopted all provisions of this
pronouncement, except for those related to the disclosure of disaggregated Level 3 activity, on
January 1, 2010, and as this guidance only amends required disclosures in the Companys condensed
consolidated financial statements, it did not have an effect upon the Companys financial position
or results of operations. The Company does not expect the adoption of the remaining provisions of
this amendment to have a significant impact on its consolidated financial statements.
In April 2010, the FASB issued accounting guidance related to the milestone method of revenue
recognition for research and development arrangements. Under this guidance, the Company may
recognize revenue contingent upon the achievement of a milestone in its entirety, in the period in
which the milestone is achieved, only if the milestone meets all the criteria within the guidance
to be considered substantive. This guidance is effective on a prospective basis for research and
development milestones achieved in the Companys fiscal year beginning April 1, 2011. Early
adoption is permitted, however, adoption of this guidance as of a date other than April 1, 2011
will require the Company to apply this guidance retrospectively effective as of April 1, 2010, and
will require disclosure of the effect of this guidance as applied to all previously reported
interim periods in the fiscal year of adoption. The Company plans to implement this guidance
prospectively, and the effect of this guidance will be limited to future transactions. The Company
does not expect adoption of this standard to have a material impact on its financial position or
results of operations.
In December 2010, the FASB issued accounting guidance related to how pharmaceutical
manufacturers should recognize and classify in their income statements fees mandated by the Patient
Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act
of 2010 (together the Acts). The Acts impose an annual fee on the pharmaceutical manufacturing
industry for each calendar year beginning on or after January 1, 2011. Under the guidance, a
liability for this fee should be estimated and recorded in full upon the first qualifying sale with
a corresponding deferred cost that is amortized to expense using a straight-line method of
allocation unless another method better allocates the fee over the calendar year that it is
payable. The Company adopted the
7
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
provisions of this pronouncement on January 1, 2011 and the adoption is not expected to have a
material effect upon the Companys financial position or results of operations for the fiscal year
ending March 31, 2011.
2. COMPREHENSIVE LOSS
Comprehensive loss is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Net loss |
|
$ |
(11,383 |
) |
|
$ |
(6,817 |
) |
|
$ |
(32,458 |
) |
|
$ |
(25,691 |
) |
Unrealized (losses) gains on available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Holding (losses) gains, net of tax |
|
|
(516 |
) |
|
|
650 |
|
|
|
431 |
|
|
|
2,410 |
|
Reclassification of unrealized losses to realized
losses on
available-for-sale securities |
|
|
|
|
|
|
94 |
|
|
|
|
|
|
|
94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (losses) gains on available-for-sale securities |
|
|
(516 |
) |
|
|
744 |
|
|
|
431 |
|
|
|
2,504 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(11,899 |
) |
|
$ |
(6,073 |
) |
|
$ |
(32,027 |
) |
|
$ |
(23,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
3. LOSS PER SHARE
Basic loss per common share is calculated based upon net loss available to holders of common
shares divided by the weighted average number of common shares outstanding. For the three and nine
months ended December 31, 2010 and 2009, as the Company was in a net loss position, the diluted
loss per share does not assume conversion or exercise of stock options and awards as they would
have an anti-dilutive effect on loss per common share. Therefore, the weighted average number of
basic and diluted voting shares of common stock outstanding for the three and nine months ended
December 31, 2010 and 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
December 31, |
|
December 31, |
(In thousands) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Weighted average number of common shares outstanding |
|
|
95,667 |
|
|
|
94,784 |
|
|
|
95,502 |
|
|
|
94,815 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following amounts are not included in the calculation of diluted loss per common share
because their effects are anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
December 31, |
|
December 31, |
(In thousands) |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Stock options |
|
|
14,499 |
|
|
|
17,658 |
|
|
|
13,614 |
|
|
|
17,801 |
|
Restricted stock units |
|
|
934 |
|
|
|
538 |
|
|
|
878 |
|
|
|
318 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
15,433 |
|
|
|
18,196 |
|
|
|
14,492 |
|
|
|
18,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. INVESTMENTS
Investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Unrealized |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses |
|
|
|
|
|
|
Amortized |
|
|
|
|
|
|
Less than |
|
|
Greater than |
|
|
Estimated |
|
|
|
Cost |
|
|
Gains |
|
|
One Year |
|
|
One Year |
|
|
Fair Value |
|
|
|
(In thousands) |
|
December 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
$ |
111,912 |
|
|
$ |
178 |
|
|
$ |
(1 |
) |
|
$ |
|
|
|
$ |
112,089 |
|
International government agency debt securities |
|
|
18,065 |
|
|
|
167 |
|
|
|
|
|
|
|
|
|
|
|
18,232 |
|
Corporate debt securities |
|
|
6,963 |
|
|
|
49 |
|
|
|
|
|
|
|
(11 |
) |
|
|
7,001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
136,940 |
|
|
|
394 |
|
|
|
(1 |
) |
|
|
(11 |
) |
|
|
137,322 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
138,141 |
|
|
|
394 |
|
|
|
(1 |
) |
|
|
(11 |
) |
|
|
138,523 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
|
52,719 |
|
|
|
|
|
|
|
(644 |
) |
|
|
|
|
|
|
52,075 |
|
Corporate debt securities |
|
|
34,203 |
|
|
|
|
|
|
|
(38 |
) |
|
|
(567 |
) |
|
|
33,598 |
|
International government agency debt securities |
|
|
15,320 |
|
|
|
|
|
|
|
(95 |
) |
|
|
|
|
|
|
15,225 |
|
Strategic equity investments |
|
|
644 |
|
|
|
229 |
|
|
|
|
|
|
|
|
|
|
|
873 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
102,886 |
|
|
|
229 |
|
|
|
(777 |
) |
|
|
(567 |
) |
|
|
101,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
5,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,440 |
|
U.S. government debt securities |
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
108,743 |
|
|
|
229 |
|
|
|
(777 |
) |
|
|
(567 |
) |
|
|
107,628 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
|
$ |
246,884 |
|
|
$ |
623 |
|
|
$ |
(778 |
) |
|
$ |
(578 |
) |
|
$ |
246,151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
|
$ |
160,876 |
|
|
$ |
204 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
161,080 |
|
International government agency debt securities |
|
|
23,441 |
|
|
|
136 |
|
|
|
|
|
|
|
(1 |
) |
|
|
23,576 |
|
Corporate debt securities |
|
|
15,225 |
|
|
|
14 |
|
|
|
|
|
|
|
(2 |
) |
|
|
15,237 |
|
Asset backed debt securities |
|
|
983 |
|
|
|
|
|
|
|
|
|
|
|
(24 |
) |
|
|
959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,525 |
|
|
|
354 |
|
|
|
|
|
|
|
(27 |
) |
|
|
200,852 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
201,726 |
|
|
|
354 |
|
|
|
|
|
|
|
(27 |
) |
|
|
202,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
26,109 |
|
|
|
|
|
|
|
|
|
|
|
(942 |
) |
|
|
25,167 |
|
U.S. government and agency debt securities |
|
|
24,727 |
|
|
|
|
|
|
|
(39 |
) |
|
|
|
|
|
|
24,688 |
|
Auction rate securities |
|
|
10,000 |
|
|
|
|
|
|
|
|
|
|
|
(1,454 |
) |
|
|
8,546 |
|
International government agency debt securities |
|
|
3,225 |
|
|
|
|
|
|
|
(2 |
) |
|
|
|
|
|
|
3,223 |
|
Strategic equity investments |
|
|
644 |
|
|
|
691 |
|
|
|
|
|
|
|
|
|
|
|
1,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64,705 |
|
|
|
691 |
|
|
|
(41 |
) |
|
|
(2,396 |
) |
|
|
62,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
5,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,440 |
|
U.S. government debt securities |
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
70,562 |
|
|
|
691 |
|
|
|
(41 |
) |
|
|
(2,396 |
) |
|
|
68,816 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
|
$ |
272,288 |
|
|
$ |
1,045 |
|
|
$ |
(41 |
) |
|
$ |
(2,423 |
) |
|
$ |
270,869 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys strategic equity investments include common stock in public companies with which
the Company has or had a collaborative arrangement.
9
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
At December 31, 2010, the Company believes that the unrealized losses on its
available-for-sale investments are temporary. In making the determination that the decline in fair
value of these securities is 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 amortized cost; the financial condition and near term prospects of
the issuers; the Companys intent not to sell these securities and the assessment that it is more
likely than not that the Company would not be required to sell these securities before the recovery
of their amortized cost basis.
In December 2010, the Company entered into an arrangement with Civitas Therapeutics, Inc.
(Civitas) whereby the Company sold, assigned or licensed to Civitas the right, title and interest
of the Company in certain of its pulmonary delivery technology and products in exchange for 15% of
the issued shares of the Series A preferred stock of Civitas and a royalty on future sales of any
products developed using the pulmonary drug delivery technology. In addition, the Company will have
a seat on the Civitas board of directors. Civitas is a privately held biopharmaceutical company
that secured a $20 million Series A financing, of which $10 million was received in December 2010
and a further $10 million is payable to Civitas upon an acceptance by the U.S. Food and Drug
Administration of an investigational new drug application for a pulmonary product. Civitas also
entered into an agreement to sublease the Companys pulmonary manufacturing facility located in
Chelsea, Massachusetts and has an option to purchase the Companys pulmonary manufacturing
equipment located at this facility.
At December 31, 2010, the Company has an approximately 13% ownership position in Civitas and
accounts for its investment in Civitas under the equity method, as the Company believes it may be
able to exercise significant influence over the operating and financial policies of Civitas. Under
the equity method, when the Company records its proportionate share of Civitas net loss, it
decreases other income (expense) in its condensed consolidated statements of operations and reduces
the carrying value of its investment in Civitas. The Company can only incur its proportionate share
of Civitas net loss up to the carrying value of the Companys investment in Civitas. Conversely,
when the Company records its proportionate share of Civitas net income, it increases other income
(expense) in its condensed consolidated statements of operations and increases the carrying value
of its investment in Civitas.
The fair value of the Civitas Series A preferred stock received by the Company exceeded the
carrying value of the assets the Company surrendered in this transaction. The difference between
these amounts has been deferred and will be recognized as other income, ratably over a period of
approximately five years in the Companys consolidated statements of operations. The carrying value
of the Companys equity investment in Civitas at December 31, 2010 is $1.3 million and is recorded
in Other assets in its condensed consolidated balance sheets. The carrying value of the deferred
gain at December 31, 2010 is $1.2 million and has been allocated between, and is recorded in,
Accounts payable and accrued expenses and Other long-term liabilities in the accompanying
condensed consolidated balance sheets.
In December 2009, the Company entered into a collaborative arrangement with, and made an
investment in, Acceleron Pharma, Inc. (Acceleron). The Companys Chairman, President and Chief
Executive Officer is one of nine members of Accelerons board of directors. The Companys December
2009 investment in Acceleron consisted of an $8.0 million purchase of shares of Series D-1
convertible, redeemable preferred stock. In July 2010, the Company invested an additional $0.5
million in exchange for shares of Series E convertible, redeemable preferred
stock and common stock warrants. The Company accounts for its investment in Acceleron under
the cost method as Acceleron is a privately-held company over which the Company does not exercise
significant influence. The Company will continue to monitor this investment to evaluate whether any
decline in its value has occurred that would be other-than-temporary, based on the implied value
from any recent rounds of financing completed by Acceleron, specific events at Acceleron, market
prices of comparable public companies and general market conditions. The Companys investment
balance of $8.5 million and $8.0 million at December 31, 2010 and March 31, 2010, respectively, is
recorded within Other assets in the accompanying condensed consolidated balance sheets.
10
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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) |
|
2010 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Cash equivalents and money market funds |
|
$ |
1,302 |
|
|
$ |
1,302 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
164,164 |
|
|
|
164,164 |
|
|
|
|
|
|
|
|
|
International government agency debt securities |
|
|
33,457 |
|
|
|
33,457 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
40,599 |
|
|
|
|
|
|
|
38,827 |
|
|
|
1,772 |
|
Strategic equity investments |
|
|
873 |
|
|
|
873 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
240,395 |
|
|
$ |
199,796 |
|
|
$ |
38,827 |
|
|
$ |
1,772 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
|
|
|
|
2010 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Cash equivalents and money market funds |
|
$ |
1,289 |
|
|
$ |
1,289 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
185,768 |
|
|
|
185,768 |
|
|
|
|
|
|
|
|
|
International government agency debt securities |
|
|
26,799 |
|
|
|
26,799 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
40,404 |
|
|
|
|
|
|
|
38,668 |
|
|
|
1,736 |
|
Auction rate securities |
|
|
8,546 |
|
|
|
|
|
|
|
|
|
|
|
8,546 |
|
Asset backed debt securities |
|
|
959 |
|
|
|
|
|
|
|
|
|
|
|
959 |
|
Strategic equity investments |
|
|
1,335 |
|
|
|
1,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
265,100 |
|
|
$ |
215,191 |
|
|
$ |
38,668 |
|
|
$ |
11,241 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no transfers or reclassifications of any securities between Level 1 and Level 2
during the nine months ended December 31, 2010. The following table illustrates the rollforward of
the fair value of the Companys investments whose fair value is determined using Level 3 inputs:
|
|
|
|
|
|
|
Fair |
|
(In thousands) |
|
Value |
|
Balance, March 31, 2010 |
|
$ |
11,241 |
|
Total unrealized gains included in comprehensive loss |
|
|
1,514 |
|
Sales and redemptions, at par value |
|
|
(10,983 |
) |
|
|
|
|
Balance, December 31, 2010 |
|
$ |
1,772 |
|
|
|
|
|
Substantially all of the Companys investments in corporate debt securities have been
classified as Level 2 investments. These securities have been initially valued at the transaction
price and subsequently valued, at the end of each reporting period, utilizing market observable
data. The market observable data includes reportable trades, benchmark yields, credit spreads,
broker/dealer quotes, bids, offers and other industry and economic events. The Company validates
the prices developed using the market observable data by obtaining market values from other pricing
sources, analyzing pricing data in certain instances and confirming that the relevant markets are
active.
The 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 RISPERDAL CONSTA
secured 7% notes (the non-recourse 7%
Notes) were fully redeemed on July 1, 2010 and had a carrying value of $51.0 million and a
fair value of $48.7 million at March 31, 2010. The estimated fair value of the non-recourse 7%
Notes at March 31, 2010 was based on a discounted cash flow model.
11
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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) |
|
2010 |
|
|
2010 |
|
Raw materials |
|
$ |
3,526 |
|
|
$ |
4,130 |
|
Work in process |
|
|
3,550 |
|
|
|
7,788 |
|
Finished goods (1) |
|
|
11,557 |
|
|
|
8,501 |
|
Consigned-out inventory (2) |
|
|
536 |
|
|
|
234 |
|
|
|
|
|
|
|
|
Total inventory |
|
$ |
19,169 |
|
|
$ |
20,653 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
At December 31, 2010 and March 31, 2010, the Company had $2.1 million
and $0.7 million of finished goods inventory located at its third
party warehouse and shipping service provider. |
|
(2) |
|
At December 31, 2010 and March 31, 2010, consigned-out inventory
relates to VIVITROL inventory in the distribution channel for which
the Company had not recognized revenue. |
7. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2010 |
|
Land |
|
$ |
301 |
|
|
$ |
301 |
|
Building and improvements |
|
|
36,782 |
|
|
|
36,759 |
|
Furniture, fixture and equipment |
|
|
63,695 |
|
|
|
62,501 |
|
Leasehold improvements |
|
|
44,466 |
|
|
|
42,660 |
|
Construction in progress |
|
|
42,845 |
|
|
|
43,695 |
|
|
|
|
|
|
|
|
Subtotal |
|
|
188,089 |
|
|
|
185,916 |
|
Less: accumulated depreciation |
|
|
(91,870 |
) |
|
|
(89,011 |
) |
|
|
|
|
|
|
|
Total property, plant and equipment, net |
|
$ |
96,219 |
|
|
$ |
96,905 |
|
|
|
|
|
|
|
|
8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2010 |
|
Accounts payable |
|
$ |
9,063 |
|
|
$ |
8,197 |
|
Accrued compensation |
|
|
12,624 |
|
|
|
15,276 |
|
Accrued other |
|
|
13,378 |
|
|
|
14,408 |
|
|
|
|
|
|
|
|
Total accounts payable and accrued expenses |
|
$ |
35,065 |
|
|
$ |
37,881 |
|
|
|
|
|
|
|
|
12
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. LONG-TERM DEBT
Long-term debt consists of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2010 |
|
Non-recourse 7% Notes |
|
$ |
|
|
|
$ |
51,043 |
|
Less: current portion |
|
|
|
|
|
|
(51,043 |
) |
|
|
|
|
|
|
|
Long-term debt |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
On July 1, 2010, in addition to the scheduled principal payment of $6.4 million, the Company
fully redeemed the balance of the non-recourse 7% Notes for $39.2 million, representing 101.75% of
the outstanding principal balance in accordance with the terms of the Indenture for the
non-recourse 7% Notes. The non-recourse 7% Notes were scheduled to mature on January 1, 2012.
10. SHARE-BASED COMPENSATION
Share-based compensation expense consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Cost of goods manufactured and sold |
|
$ |
385 |
|
|
$ |
434 |
|
|
$ |
1,271 |
|
|
$ |
1,263 |
|
Research and development |
|
|
1,573 |
|
|
|
759 |
|
|
|
4,726 |
|
|
|
2,485 |
|
Selling, general and administrative |
|
|
3,834 |
|
|
|
2,179 |
|
|
|
9,199 |
|
|
|
7,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share-based compensation expense |
|
$ |
5,792 |
|
|
$ |
3,372 |
|
|
$ |
15,196 |
|
|
$ |
10,811 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2010 and March 31, 2010, $0.5 million, respectively, of share-based
compensation expense was capitalized and recorded as Inventory in the accompanying condensed
consolidated balance sheets.
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 net restructuring charges of approximately $6.9 million
in the year ended March 31, 2008. Activity related to the 2008 Restructuring in the nine months
ended December 31, 2010 was as follows:
|
|
|
|
|
(In thousands) |
|
Balance |
|
Accrued restructuring, March 31, 2010 |
|
$ |
3,596 |
|
Payments for facility closure costs |
|
|
(662 |
) |
Other adjustments |
|
|
397 |
|
|
|
|
|
Accrued Restructuring, December 31, 2010 |
|
$ |
3,331 |
|
|
|
|
|
At December 31, 2010 and March 31, 2010, the restructuring liability related to the 2008
Restructuring consists of $0.7 million and $0.6 million classified as current, respectively, and
$2.6 million and $3.0 million classified as long-term, respectively, in the accompanying condensed
consolidated balance sheets. As of December 31, 2010, the Company had paid in cash, written off,
recovered and made restructuring charge adjustments that totaled approximately $0.6 million in
facility closure costs, $2.9 million in employee separation costs and $0.2 million in other
contract termination costs in connection with the 2008 Restructuring. The $3.3 million remaining in
the restructuring accrual at December 31, 2010 is expected to be paid out through fiscal 2016 and
relates primarily to future lease costs associated with an exited facility.
13
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, 2010, 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 recorded an income tax provision of less than $0.1 million and an income tax
benefit of $1.0 million for the three and nine months ended December 31, 2010, respectively. The
income tax benefit for the nine months ended December 31, 2010 is primarily related to a $0.8
million tax benefit for bonus depreciation pursuant to the Small Business Jobs Act of 2010 (Act).
Bonus depreciation increases the Companys 2010 alternative minimum tax (AMT) net operating loss
(NOL) carryback and will allow the Company to recover AMT paid in the carryback period. The tax
benefit was recorded as a discrete item during the three months ended September 30, 2010, the
period in which the Act was enacted. The income tax provision of less than $0.1 million and the
income tax benefit of $0.1 million for the three and nine months ended December 31, 2009,
respectively, represented the amount the Company estimated it would benefit from the Housing and
Economic Recovery Act of 2008.
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 does not believe that it is currently party to 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.
14
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 are headquartered in Waltham, Massachusetts and have a
research facility in Massachusetts and a commercial manufacturing facility in Ohio. We leverage our
formulation expertise and proprietary product platforms to develop, both with partners and on our
own, innovative and competitively advantaged medications that can enhance patient outcomes in major
therapeutic areas. Our robust pipeline includes extended-release injectable and oral products for
the treatment of prevalent, chronic diseases, such as central nervous system (CNS) disorders,
reward disorders, addiction, diabetes and autoimmune disorders.
The following discussion should be read in conjunction with our condensed consolidated
financial statements and related notes beginning on page 3 of this Quarterly Report on Form 10-Q,
and the audited consolidated financial statements and notes thereto, and Managements Discussion
and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form
10-K for the year ended March 31, 2010, which has been filed with the Securities and Exchange
Commission (SEC).
Forward-Looking Statements
This document contains and incorporates by reference forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934. In some cases, these statements can be identified by the use of forward looking
terminology such as may, will, could, should, would, expect, anticipate, continue
or other similar words. These statements discuss future expectations; and contain projections of
results of operations or of financial condition, or state trends and known uncertainties or other
forward looking information. Forward-looking statements in this Quarterly Report on Form 10-Q
include, without limitation, statements regarding:
|
|
our expectations regarding our financial performance, including, but not limited to
revenues, expenses, gross margins, liquidity, capital expenditures and income taxes; |
|
|
|
statements by Amylin Pharmaceuticals, Inc.
(Amylin) concerning the expected commencement date and
duration of the thorough QT (tQT) study and the date by
when it expects to submit results of the tQT study to the United
States (U.S.) Food and Drug Administration
(FDA);
|
|
|
|
our expectations regarding our product candidates, including
the timing, funding and expense, feasibility and potential for
success of clinical development activities; regulatory
review; and commercial potential of such product candidates; |
|
|
|
the continuation of our collaborations and other significant agreements and our ability to
establish and maintain successful development collaborations; |
|
|
|
the impact of new accounting pronouncements; |
|
|
|
our expectations concerning the status, intended use and financial impact of and
arrangements involving our properties, including manufacturing facilities; and |
15
|
|
our future capital requirements and capital expenditures and our ability to finance
our operations and capital requirements. |
You are cautioned that forward-looking statements are based on current expectations and are
inherently uncertain. Actual performance and results of operations may differ materially from those
projected or suggested in the forward-looking statements due to various risks and uncertainties,
including:
|
|
the FDA and foreign regulatory
agencies may not approve BYDUREONTM
(exenatide for extended-release injectable suspension) and, even if approved, such product may not be successfully
commercialized; |
|
|
we rely solely on our collaborative partners to determine and implement, and to inform us
in a timely manner of any developments concerning, the regulatory and marketing strategies for
RISPERDAL® CONSTA®
((risperidone) long-acting injection)
and BYDUREON, including the four-week formulation of exenatide currently
being developed by us, and our collaborators could elect to terminate or delay programs at any
time and disputes with collaborators or failure to negotiate acceptable collaborative
arrangements for our technologies could occur; |
|
|
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; |
|
|
clinical trials may take more time or consume more resources than initially envisioned and
the results of earlier clinical trials may not necessarily be predictive of the safety and
efficacy results of larger clinical trials; |
|
|
U.S. and foreign regulatory agencies may refuse to accept applications for marketing
authorization for our product candidates, may 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 or acceptance
in the marketplace; |
|
|
difficulties in obtaining and enforcing our patents and difficulties with the patent rights
of others could occur;
|
16
|
|
we may suffer potential costs resulting from product liability claims or other third party
claims; |
|
|
we may incur losses in the future; |
|
|
we may not be able to liquidate or otherwise recoup our investments in corporate debt
securities; |
|
|
the impact of recently enacted, and any future, health reform
legislation may be greater than initially expected; |
|
|
exchange rate valuations and fluctuations may negatively impact our revenues, results of
operations and financial condition; and |
|
|
the other risks and uncertainties described or discussed in Part 1, Item 1A, Risk Factors
of our Annual Report on Form 10-K for the year ended March 31, 2010. |
The forward-looking statements contained and incorporated herein represent our judgment as of
the date of this Quarterly Report, and we caution readers not to place undue reliance on such
statements. The information contained in this Quarterly Report is provided by us as of the date of
this Quarterly Report, and, except as required by law, we do not undertake any obligation to update
any forward-looking statements contained in this document as a result of new information, future
events or otherwise.
Executive Summary
Net
loss for the three months ended December 31, 2010 was
$11.4 million, or $0.12 per common
share, basic and diluted, as compared to a net loss of $6.8 million, or $0.07 per common share,
basic and diluted, for the three months ended December 31, 2009. Net loss for the nine months ended
December 31, 2010 was $32.5 million, or $0.34 per common share, basic and diluted, as compared to a
net loss of $25.7 million, or $0.27 per common share, basic and diluted, for the nine months ended
December 31, 2009. Our most significant commercialized products are RISPERDAL CONSTA, which we
manufacture for the treatment of schizophrenia and bipolar I
disorder, and VIVITROL® (naltrexone for extended-release injectable suspension), which we
developed, manufacture and commercialize for alcohol dependence and for the prevention of relapse
to opioid dependence, following opioid detoxification. RISPERDAL CONSTA and VIVITROL comprised 80%
and 18%, respectively, of our consolidated revenues for the three months ended December 31, 2010
and 83% and 15%, respectively, of our consolidated revenues for the nine months ended December 31,
2010.
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 the treatment of
schizophrenia and for the treatment of bipolar I disorder. The medication uses our proprietary
Medisorb® injectable extended-release technology to deliver and maintain
therapeutic medication levels in the body through just one injection every two weeks. RISPERDAL
CONSTA is marketed by
Ortho-McNeil-Janssen Pharmaceuticals, Inc. and Janssen Pharmaceutica International,
a division of Cilag International AG (Janssen)
and sold in more than 90 countries, and is exclusively manufactured
by us. RISPERDAL CONSTA was first approved for the treatment of schizophrenia by regulatory
authorities in the United Kingdom and Germany in August 2002 and by the FDA in October 2003. The
Pharmaceuticals and Medical Devices Agency in Japan approved RISPERDAL CONSTA for the treatment of
schizophrenia in April 2009, and it is the first long-acting atypical antipsychotic to be available
in Japan. In May 2009, the FDA approved RISPERDAL CONSTA as both monotherapy and adjunctive therapy
to lithium or valproate in the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA is
also approved for the maintenance treatment of bipolar I disorder in Canada, Australia and Saudi
Arabia.
We developed VIVITROL, an extended-release Medisorb formulation of naltrexone, as the first
and only once-monthly, non-narcotic, non-addictive injectable medication for the treatment of
alcohol dependence and for the prevention of relapse to opioid dependence following opioid
detoxification. VIVITROL was approved by the FDA in April 2006 for the treatment of alcohol
dependence and was launched in the U.S. in June 2006. In December 2007, we exclusively licensed the
right to commercialize VIVITROL for the treatment of alcohol dependence and opioid dependence in
Russia and other countries in the Commonwealth of Independent States
(CIS) to Cilag GmbH International (Cilag). In August
2008, the Russian regulatory authorities approved VIVITROL for the treatment of alcohol dependence,
and Cilag launched VIVITROL in Russia in March 2009.
In October 2010, the FDA approved VIVITROL for the prevention of relapse to opioid dependence,
following opioid detoxification.
17
We are collaborating with Amylin on the development of a once-weekly formulation of exenatide,
called BYDUREON, for the treatment of type 2 diabetes. BYDUREON is an extended-release Medisorb
injectable formulation of Amylins BYETTA® (exenatide) and is being developed
with the goal of providing patients with an effective and more patient-friendly treatment option.
In April 2010, Eli Lilly & Company (Lilly) announced that the European Medicines Agency (EMA) had accepted the
Marketing Authorization Application filing for BYDUREON for the treatment of type 2 diabetes. In
October 2010, Amylin, Lilly and we announced that the FDA issued a complete response letter
regarding the New Drug Application (NDA) for BYDUREON. In
the complete response letter, the FDA requested a tQT
study and the submission of the results of the clinical study, DURATION-5, to evaluate the
efficacy, and the labeling of the safety and effectiveness, of the commercial formulation of
BYDUREON.
In January 2010, Amylin announced that the FDA provided written
approval of the study design for a tQT study for BYDUREON and that,
with the approval of the study design, Amylin intends to commence the
study in February 2011 and plans to submit the results of this study to
the FDA in the second half of calendar 2011.
In April 2010, we announced plans for the development of ALKS 33, a proprietary candidate, for
the treatment of binge-eating disorder and as a combination therapy with buprenorphine, an existing
medication for the treatment of opioid addiction, for the treatment of addiction and mood
disorders. In October 2010, we announced positive topline results from a randomized, double-blind,
multi-dose, placebo-controlled phase 1 clinical study that assessed the safety, tolerability and
pharmacodynamic effects of the combination of ALKS 33 and buprenorphine when administered alone,
and in combination, to 12 opioid-experienced users. Data from the study showed that the combination
therapy was generally well-tolerated and sublingual administration of ALKS 33 effectively blocked
the agonist effects of buprenorphine. Based on these positive results, we expect to initiate a
phase 2a study of the combination therapy for the treatment of cocaine addiction in the first half
of calendar year 2011. The phase 2a study is expected to be funded through a grant from the
National Institute on Drug Abuse (NIDA). NIDA has granted us up to $2.4 million to accelerate the
clinical development of the ALKS 33 and buprenorphine combination therapy. Currently, there are no
medications approved for the treatment of cocaine addiction.
In December 2010, we announced preliminary results from a phase 2 study of ALKS 33 designed to
assess the safety and efficacy of daily oral administration of three different dose levels of ALKS
33 compared to placebo in 400 alcohol dependent patients. The safety,
dose response and efficacy profile demonstrated in the study support
the unique pharmacologic properties of ALKS 33 and the further study
of ALKS 33 for reward disorders and other central nervous system
disorders.
In January 2011, we announced that ALKS 33, in combination with buprenorphrine, is being
studied for treatment-resistant depression (TRD). TRD, which is also known as refractory
depression, refers to depressive episodes that are not adequately controlled by standard
antidepressant therapy. Depression is a serious and chronic disease that affects more than 20
million American adults each year, and finding the right treatment can be difficult for many
patients. Approximately half of depressed patients have an inadequate response to monotherapy, and
as many as 20% have chronic depression despite multiple interventions. We plan to file an
Investigational New Drug application (IND) in mid-calendar year 2011 and initiate a phase 1/2
trial by the end of calendar year 2011.
In April 2010, we commenced a multicenter, randomized, double-blind, placebo-controlled,
multi-dose study designed to evaluate the efficacy, safety and tolerability of ALKS 37, an orally
active, peripherally-restricted opioid antagonist for the treatment of opioid-induced bowel
dysfunction (OBD), in approximately 60 patients with OBD. We expect to report preliminary results
from the phase 2 study of ALKS 37 in the first quarter of calendar year 2011. The results of this
phase 2 study will inform further development of ALKS 36, a co-formulation of an opioid analgesic
and ALKS 37, for the treatment of pain without the side effects of constipation.
ALKS 9070 is a once-monthly, injectable, sustained-release
version of aripiprazole for the treatment of schizophrenia and
leverages our proprietary LinkeRxTM product
platform. Aripiprazole is commercially available
under the name ABILIFY® for the treatment of a number of CNS disorders. We
commenced a phase 1/2 clinical study for ALKS 9070 for the treatment of schizophrenia and expect to
report topline data from the study of ALKS 9070 in the first half of calendar year 2011.
18
Results of Operations
Manufacturing Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Manufacturing revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
25.5 |
|
|
$ |
27.2 |
|
|
$ |
(1.7 |
) |
|
$ |
84.4 |
|
|
$ |
87.0 |
|
|
$ |
(2.6 |
) |
Polymer |
|
|
0.6 |
|
|
|
1.5 |
|
|
|
(0.9 |
) |
|
|
1.7 |
|
|
|
2.9 |
|
|
|
(1.2 |
) |
VIVITROL |
|
|
0.1 |
|
|
|
|
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
0.4 |
|
|
|
(0.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing revenues |
|
$ |
26.2 |
|
|
$ |
28.7 |
|
|
$ |
(2.5 |
) |
|
$ |
86.2 |
|
|
$ |
90.3 |
|
|
$ |
(4.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We earn manufacturing revenue on sales of RISPERDAL CONSTA 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, 2010 and 2009, our RISPERDAL
CONSTA manufacturing revenues were based on an average of 7.5% of Janssens unit net sales price.
We anticipate that we will continue to earn manufacturing revenues at 7.5% of Janssens unit net
sales price of RISPERDAL CONSTA for product shipped in the fiscal year ending March 31, 2011 and
beyond.
The decrease in RISPERDAL CONSTA manufacturing revenues for the three months ended December
31, 2010, as compared to the three months ended December 31, 2009, was primarily due to a 6%
decrease in the unit net sales price partially offset by a 28% increase in the number of units
shipped to Janssen. The decrease in RISPERDAL CONSTA manufacturing revenues for the nine months
ended December 31, 2010, as compared to the nine months ended December 31, 2009, was primarily due
to a 1% decrease in the unit net sales price, partially offset by an 11% increase in the number of
units shipped to Janssen. The decrease in the unit net sales price for both the three and nine
month periods is primarily due to increased sales deductions recorded by Janssen on RISPERDAL
CONSTA sales as a result of healthcare reform in the U.S., as further described in Product Sales,
net, below, and the strengthening of the U.S. dollar in relation to the foreign currencies in which
the product was sold.
We earn manufacturing revenue on sales of polymer under our arrangement with Amylin when
product is shipped to them, at an agreed upon price. The polymer is used in the formulation of
BYDUREON. The decrease in polymer manufacturing revenues for the three and nine months ended
December 31, 2010, as compared to the three and nine months ended December 31, 2009, was due to a
62% and 39% decrease, respectively, in the amount of polymer shipped to Amylin.
We earn manufacturing revenue on sales of VIVITROL under our arrangement with Cilag for resale
in Russia when product is shipped to them, at an agreed upon price. The increase in VIVITROL
manufacturing revenues for the three months ended December 31, 2010, as compared to the three
months ended December 31, 2009, was due to no shipments of VIVITROL to Cilag during the three
months ended December 31, 2009. The decrease in VIVITROL manufacturing revenues for the nine months
ended December 31, 2010, as compared to the nine months ended December 31, 2009, was due to a 71%
decrease in the amount of VIVITROL shipped to Cilag.
19
Royalty Revenues
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Royalty revenues |
|
$ |
9.8 |
|
|
$ |
10.0 |
|
|
$ |
(0.2 |
) |
|
$ |
28.2 |
|
|
$ |
27.5 |
|
|
$ |
0.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Substantially all of our royalty revenues for the three and nine months ended December 31,
2010 and 2009 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, 2010 were based on RISPERDAL CONSTA sales of $387.8 million and $1,121.3
million, respectively. 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.
Product Sales, net
Our product sales consist of sales of VIVITROL in the U.S. to wholesalers, specialty
distributors and specialty pharmacies. The following table presents the adjustments deducted from
VIVITROL product sales, gross to arrive at VIVITROL product sales, net during the three and nine
months ended December 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
%of Sales |
|
|
2009 |
|
|
%of Sales |
|
|
2010 |
|
|
%of Sales |
|
|
2009 |
|
|
%of Sales |
|
Product sales, gross |
|
$ |
9.8 |
|
|
|
100.0 |
% |
|
$ |
7.2 |
|
|
|
100.0 |
% |
|
$ |
28.0 |
|
|
|
100.0 |
% |
|
$ |
17.7 |
|
|
|
100.0 |
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medicaid rebates |
|
|
(1.1 |
) |
|
|
(11.2 |
)% |
|
|
(0.3 |
) |
|
|
(4.2 |
)% |
|
|
(1.9 |
) |
|
|
(6.8 |
)% |
|
|
(0.6 |
) |
|
|
(3.4 |
)% |
Chargebacks |
|
|
(0.7 |
) |
|
|
(7.1 |
)% |
|
|
(0.4 |
) |
|
|
(5.6 |
)% |
|
|
(1.6 |
) |
|
|
(5.7 |
)% |
|
|
(0.7 |
) |
|
|
(4.0 |
)% |
Reserve for
inventory in the
channel (1) |
|
|
0.6 |
|
|
|
6.1 |
% |
|
|
(0.4 |
) |
|
|
(5.6 |
)% |
|
|
(1.1 |
) |
|
|
(3.9 |
)% |
|
|
(0.5 |
) |
|
|
(2.8 |
)% |
Wholesaler fees |
|
|
(0.3 |
) |
|
|
(3.0 |
)% |
|
|
(0.3 |
) |
|
|
(4.2 |
)% |
|
|
(0.9 |
) |
|
|
(3.2 |
)% |
|
|
(0.7 |
) |
|
|
(4.0 |
)% |
Other |
|
|
(0.6 |
) |
|
|
(6.1 |
)% |
|
|
(0.3 |
) |
|
|
(4.2 |
)% |
|
|
(2.1 |
) |
|
|
(7.5 |
)% |
|
|
(0.9 |
) |
|
|
(5.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
(2.1 |
) |
|
|
(21.3 |
)% |
|
|
(1.7 |
) |
|
|
(23.8 |
)% |
|
|
(7.6 |
) |
|
|
(27.1 |
)% |
|
|
(3.4 |
) |
|
|
(19.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
7.7 |
|
|
|
78.7 |
% |
|
$ |
5.5 |
|
|
|
76.2 |
% |
|
$ |
20.4 |
|
|
|
72.9 |
% |
|
$ |
14.3 |
|
|
|
80.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Our reserve for inventory in the distribution channel is an estimate
that reflects the deferral of the recognition of revenue on shipments
of VIVITROL to our customers until the product has left the
distribution channel, as we do not yet have the history to reasonably
estimate returns related to these shipments. We estimate the product
shipments out of the distribution channel based on data provided by
external sources, including information on inventory levels provided
by our customers as well as prescription information. |
The increase in product sales, gross for the three and nine months ended December 31, 2010, as
compared to the three and nine months ended December 31, 2009, was primarily due to a 14% and 36%
increase in the number of units sold into the distribution channel, respectively, and a 20% and 16%
increase in the sales price, respectively. The increase in Medicaid rebates as a percentage of
gross sales for the three and nine months ended December 31, 2010, as compared to the three and
nine months ended December 31, 2009, is primarily due to an increase in customers purchasing
VIVITROL through Medicaid and an increase in the Medicaid rebate per unit due to an increase in our
selling price on October 1, 2010 as well as an increase in Medicaid rebates due to the U.S.
healthcare reform legislation.
Our product sales may fluctuate from period to period as a result of factors such as end user
demand, which can create uneven purchasing patterns by our customers. Our product sales may also
fluctuate as the result of changes or adjustments to our reserves or changes in government or
customer rebates. For example, in March 2010, U.S. healthcare reform legislation was enacted, which
contains several provisions that we expect will negatively affect
our net sales as a percentage of gross sales, specifically, the increase in the minimum
Medicaid rebates, the expansion of those entities entitled to receive Medicaid rebates based on the
use of our product and the expansion of those entities entitled to purchase our products at a
discounted basis under the 340(B)/Public Health Services drug pricing program. It is possible that
the effect of this legislation could further adversely impact our future revenues. We are still
assessing the full extent of this legislations future impact on our business.
20
Net Collaborative Profit
Net collaborative profit for the nine months ended December 31, 2009 of $5.0 million consisted
of revenue earned as a result of the $11.0 million payment we received from Cephalon to fund their
share of estimated VIVITROL losses during the one-year period following the termination of the
VIVITROL collaboration in December 2008. We initially recorded the $11.0 million as deferred
revenue and recognized it as revenue through the application of a proportional performance model
based on VIVITROL losses. The $11.0 million payment was fully recognized as revenue during the six
months ended September 30, 2009.
Cost of Goods Manufactured and Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Cost of goods manufactured and
sold: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
9.5 |
|
|
$ |
8.4 |
|
|
$ |
(1.1 |
) |
|
$ |
31.2 |
|
|
$ |
30.2 |
|
|
$ |
(1.0 |
) |
VIVITROL |
|
|
2.4 |
|
|
|
1.1 |
|
|
|
(1.3 |
) |
|
|
6.4 |
|
|
|
5.7 |
|
|
|
(0.7 |
) |
Polymer |
|
|
1.0 |
|
|
|
0.6 |
|
|
|
(0.4 |
) |
|
|
1.8 |
|
|
|
1.9 |
|
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods manufactured and
sold |
|
$ |
12.9 |
|
|
$ |
10.1 |
|
|
$ |
(2.8 |
) |
|
$ |
39.4 |
|
|
$ |
37.8 |
|
|
$ |
(1.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in cost of goods manufactured for RISPERDAL CONSTA in the three and nine months
ended December 31, 2010, as compared to the three and nine months ended December 31, 2009, was
primarily due to a 28% and 11% increase in the number of units shipped to Janssen, respectively,
partially offset by a 12% and 7% decrease in the unit cost of RISPERDAL CONSTA, respectively. The
decrease in the unit cost of RISPERDAL CONSTA in the three and nine months ended December 31, 2010,
as compared to the three and nine months ended December 31, 2009, was partially due to a decrease
in costs incurred for scrap of $0.9 million and $1.9 million, respectively.
The increase in cost of goods manufactured and sold for VIVITROL in the three and nine months
ended December 31, 2010, as compared to the three and nine months ended December 31, 2009, was
primarily due to a 55% and 12% increase in the number of units sold out of the distribution
channel, respectively. Also included in cost of goods manufactured and sold for VIVITROL in the
three and nine months ended December 31, 2010 are idle capacity charges of $0.4 million and $1.8
million, respectively, that are the result of managing VIVITROL inventory levels and reducing
manufacturing output. No idle capacity charges were incurred during the three and nine months ended
December 31, 2009. These increases to cost of goods manufactured and sold for VIVITROL were
partially offset by a decrease in the amounts incurred for scrap of $0.1 million and $1.9 million
in the three and nine months ended December 31, 2010, as compared to the three and nine months ended
December 31, 2009, respectively.
The increase in the cost of goods manufactured for polymer in the three months ended December
31, 2010, as compared to the three months ended December 31, 2009, was due to a $0.3 million
increase in costs incurred for scrap and $0.3 million in idle capacity charges, partially offset by
a 62% decrease in the amount of polymer shipped to Amylin. The decrease in the cost of goods
manufactured for polymer in the nine months ended December 31, 2010, as compared to the nine months
ended December 31, 2009, was primarily due to a 39% decrease in the amount of polymer shipped to
Amylin.
Research and Development Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Research and development |
|
$ |
22.5 |
|
|
$ |
22.6 |
|
|
$ |
0.1 |
|
|
$ |
69.4 |
|
|
$ |
68.8 |
|
|
$ |
(0.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amount of research and development (R&D) expense did not materially change in the three
and nine months ended December 31, 2010, as compared to the three and nine months ended December
31, 2009, although the composition of the expense has changed. We saved $4.6 million and $19.4
million in the three and nine months
21
ended December 31, 2010, respectively, in relocation and
occupancy expenses as a result of the relocation of our corporate headquarters from Cambridge,
Massachusetts to Waltham, Massachusetts, which was substantially completed during the fourth
quarter of fiscal 2010. In the three and nine months ended December 31, 2010, we spent $3.0 million
and $9.6 million more in internal clinical and preclinical study, laboratory and license and
collaboration expenses, $1.7 million and $4.7 million more in employee related expenses and $0.8
million and $4.1 million more in professional service expense, as compared to the three and nine
months ended December 31, 2009. The increase in internal clinical and preclinical study, laboratory
and license and collaboration expenses is due to an increase in the number of ongoing studies and
clinical trials. The increase in employee related expense is primarily due to an increase in
share-based compensation expense due to recent equity grants awarded with a higher grant-date fair
value than older grants, as well as the exclusion of certain prior grants that have vested and are
no longer included in share-based compensation expense. The increase in professional service
expense is primarily due to activities related to the approval of VIVITROL for opioid dependence.
A significant portion of our R&D expenses (including laboratory supplies, travel, dues and
subscriptions, recruiting costs, temporary help costs, consulting costs and allocable costs such as
occupancy and depreciation) are not tracked by project as they benefit multiple projects or our
technologies in general. Expenses incurred to purchase specific services from third parties to
support our collaborative R&D activities are tracked by project and may be reimbursed to us by our
partners. We account for our R&D expenses on a departmental and functional basis in accordance with
our budget and management practices.
Selling, General and Administrative Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Selling, general
and administrative |
|
$ |
20.5 |
|
|
$ |
17.7 |
|
|
$ |
(2.8 |
) |
|
$ |
58.7 |
|
|
$ |
57.6 |
|
|
$ |
(1.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in selling, general and administrative (SG&A) expense for the three and nine
months ended December 31, 2010, as compared to the three and nine months ended December 31, 2009,
was primarily due to an increase in share-based compensation of $1.7 million and $2.1 million,
respectively, and marketing expenses of $1.2 million and $2.0 million, respectively, offset by a
reduction in professional services of $1.0 million and $4.4 million, respectively. The increase in
share-based compensation is primarily due to recent equity grants awarded with a higher grant-date
fair value than older grants, as well as the exclusion of certain prior grants that have vested and
are no longer included in share-based compensation expense. The increase in marketing expenses is
primarily due to costs incurred leading up to the launch of VIVITROL
for opioid dependence, and the
decrease in professional services is primarily due to start-up costs related to the
commercialization of VIVITROL in fiscal year 2010 that were not incurred during fiscal year 2011.
Other Income (Expense), Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Interest income |
|
$ |
0.7 |
|
|
$ |
1.0 |
|
|
$ |
(0.3 |
) |
|
$ |
2.2 |
|
|
$ |
3.7 |
|
|
$ |
(1.5 |
) |
Interest expense |
|
|
|
|
|
|
(1.4 |
) |
|
|
1.4 |
|
|
|
(3.3 |
) |
|
|
(4.7 |
) |
|
|
1.4 |
|
Other expense, net |
|
|
(0.1 |
) |
|
|
(0.2 |
) |
|
|
0.1 |
|
|
|
(0.3 |
) |
|
|
(0.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income
(expense), net |
|
$ |
0.6 |
|
|
$ |
(0.6 |
) |
|
$ |
1.2 |
|
|
$ |
(1.4 |
) |
|
$ |
(1.3 |
) |
|
$ |
(0.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in interest income for the three and nine months ended December 31, 2010, as
compared to the three and nine months ended December 31, 2009, was due to a lower average balance
of cash and investments. The decrease in interest expense in the three and nine months ended
December 31, 2010, as compared to the three and nine months ended December 31, 2009, was due to the
early redemption of our non-recourse 7% Notes on July 1, 2010. As a result of this transaction, we
recorded charges of $1.4 million relating to the write-off of the unamortized portion of deferred
financing costs and $0.8 million primarily related to the premium paid on the redemption of the
non-recourse 7% Notes. We expect to save $3.2 million in interest and accretion expense through the
previously scheduled maturity date of January 1, 2012 as a result of redeeming the non-recourse 7%
Notes on July 1, 2010.
22
Income Taxes
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
Nine Months Ended December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
|
Change |
|
|
2010 |
|
|
2009 |
|
|
Change |
|
Income tax provision (benefit) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(1.0 |
) |
|
$ |
(0.1 |
) |
|
$ |
0.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We recorded an income tax provision of less than $0.1 million and an income tax benefit of
$1.0 million for the three and nine months ended December 31, 2010, respectively. The income tax
benefit for the nine months ended December 31, 2010 is primarily related to a $0.8 million tax
benefit for bonus depreciation pursuant to the Small Business Jobs Act of 2010 (Act). Bonus
depreciation increases our 2010 alternative minimum tax (AMT) net operating loss (NOL)
carryback and will allow us to recover AMT paid in the carryback period. The tax benefit was
recorded as a discrete item during the three months ended September 30, 2010, the period in which
the Act was enacted. The income tax provision of less than $0.1 million and the income tax benefit
of $0.1 million for the three and nine months ended December 31, 2009, respectively, represented
the amount we estimated we would benefit from the Housing and Economic Recovery Act of 2008.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In millions) |
|
2010 |
|
|
2010 |
|
Cash and cash equivalents |
|
$ |
38.9 |
|
|
$ |
79.3 |
|
Investments short-term |
|
|
138.5 |
|
|
|
202.1 |
|
Investments long-term |
|
|
107.6 |
|
|
|
68.8 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents and investments |
|
$ |
285.0 |
|
|
$ |
350.2 |
|
|
|
|
|
|
|
|
Working capital |
|
$ |
194.2 |
|
|
$ |
247.1 |
|
Outstanding borrowings current and long-term |
|
$ |
|
|
|
$ |
51.0 |
|
Our cash flows for the nine months ended December 31, 2010 and 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
|
December 31, |
|
(In millions) |
|
2010 |
|
|
2009 |
|
Cash and cash equivalents, beginning of period |
|
$ |
79.3 |
|
|
$ |
86.9 |
|
Cash (used in) operating activities |
|
|
(14.2 |
) |
|
|
(12.3 |
) |
Cash provided by investing activities |
|
|
17.2 |
|
|
|
19.5 |
|
Cash (used in) financing activities |
|
|
(43.4 |
) |
|
|
(20.2 |
) |
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
38.9 |
|
|
$ |
73.9 |
|
|
|
|
|
|
|
|
Our primary source of liquidity is cash provided by our cash and investment portfolio of
$285.0 million at December 31, 2010. The increase in cash used in operating activities during the
nine months ended December 31, 2010, as compared to the nine months ended December 31, 2009, is
primarily due to the redemption of our non-recourse 7% Notes on July 1, 2010. On July 1, 2010, in
addition to a scheduled principal payment of $6.4 million, we redeemed the balance of our
non-recourse 7% Notes in full in exchange for $39.2 million, representing 101.75% of the
outstanding principal balance in accordance with the terms of the Indenture for the non-recourse 7%
Notes. We allocated $6.6 million of the principal payments made during the nine months ended
December 31, 2010 to operating activities to account for the original issue discount on the
non-recourse 7% Notes, and the remaining $45.4 million of principal payments was allocated to
financing activities in the condensed consolidated statement of cash flows. This increase in cash
used for operating activities was partially offset by an increase in the inflow of cash from our
working capital accounts during the nine months ended December 31, 2010, as compared to the nine
months ended December 31, 2009.
23
The decrease in cash provided by our investing activities in the nine months ended December
31, 2010, as compared to the nine months ended December 31, 2009, is primarily due to a decrease in
the net sales of investments of $11.0 million, partially offset by a decrease in amounts invested
in Acceleron.
The increase in cash flows used in financing activities during the nine months ended December
31, 2010, as compared to the nine months ended December 31, 2009, is primarily due to the
redemption of our non-recourse 7% Notes on July 1, 2010, partially offset by the purchase of $2.7
million of treasury stock during the nine months ended December 31, 2009. During the nine months
ended December 31, 2010, we did not make any purchases of treasury stock.
Our investments at December 31, 2010 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Estimated |
|
(In millions) |
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Fair Value |
|
Investments short-term |
|
$ |
138.1 |
|
|
$ |
0.4 |
|
|
$ |
|
|
|
$ |
138.5 |
|
Investments long-term
available-for-sale |
|
|
102.9 |
|
|
|
0.2 |
|
|
|
(1.3 |
) |
|
|
101.8 |
|
Investments long-term
held-to-maturity |
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
246.9 |
|
|
$ |
0.6 |
|
|
$ |
(1.3 |
) |
|
$ |
246.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our investment objectives are, first, to preserve liquidity and conserve capital and, second,
to generate investment income. We mitigate credit risk to our investments by maintaining a
well-diversified portfolio that limits the amount of investment exposure as to institution,
maturity and investment type. However, the value of our investments may be adversely affected by
the instability of the global financial markets which could, in turn, adversely impact our
financial position and our overall liquidity. Our available-for-sale investments consist primarily
of short and long-term U.S. government and agency debt securities, debt securities issued by
foreign agencies, which are backed by foreign governments, and corporate debt securities. Our
held-to-maturity investments consist of securities that are restricted and held as collateral under
certain letters of credit related to certain of our lease agreements.
We classify our available-for-sale investments that are in an unrealized loss position which
do not mature within 12 months as long-term investments. We have the intent and ability to hold
these investments until recovery, which may be at maturity, and it is more likely than not that we
would not be required to sell these securities before recovery of their amortized cost. At December
31, 2010, we performed an analysis of our investments with unrealized losses for impairment and
determined that they are temporarily impaired.
At December 31, 2010 and March 31, 2010, 1% and 4%, respectively, of our investments are
valued using unobservable, or Level 3, inputs to determine fair value as they are not actively
trading and fair values could not be derived from quoted market prices. During the nine months
ended December 31, 2010, $11.0 million of our Level 3 investments were redeemed at par by the
issuers.
Borrowings
We did not have any outstanding borrowings at December 31, 2010. On July 1, 2010, in addition
to a scheduled principal payment of $6.4 million, we redeemed the balance of our non-recourse 7%
Notes in full in exchange for $39.2 million, representing 101.75% of the outstanding principal
balance in accordance with the terms of the Indenture for the non-recourse 7% Notes. We expect to
save $3.2 million in interest and accretion expense through the previously scheduled maturity date
of January 1, 2012 as a result of redeeming these notes on July 1, 2010.
Contractual Obligations
Refer to Part II, Item 7 of our Annual Report on Form 10-K for the year ended March 31, 2010
in the Contractual Obligations section for a discussion of our contractual obligations. Our
contractual obligations as of December 31, 2010 were not materially changed from the date of that
report with the exception of the non-recourse 7% Notes which, as noted in the Borrowings section
above, were redeemed in full on July 1, 2010.
24
Off-Balance Sheet Arrangements
At December 31, 2010, we were not a party to any off-balance sheet arrangements that have, or
are reasonably likely to have, a current or future effect on our financial condition, changes in
financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or
capital resources material to investors.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations is based on
our financial statements, which have been prepared in accordance with 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 our
financial statements and the reported amounts of revenues and expenses during the reporting period.
Actual results may differ from these estimates under different assumptions or conditions. Refer to
Part II, Item 7 of our Annual Report on Form 10-K for the year ended March 31, 2010 in the
Critical Accounting Estimates section for a discussion of our critical accounting estimates.
New Accounting Standards
Refer to New Accounting Pronouncements included in Note 1, Summary of Significant Accounting
Policies in the accompanying Notes to Condensed Consolidated Financial Statements for a discussion
of new accounting standards.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
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 fiscal year ended March 31, 2010. We regularly review our marketable securities holdings and
shift our holdings to those that best meet our investment objectives, which are, first, to preserve
liquidity and conserve capital and, second, to generate investment income. Apart from such
adjustments to our investment portfolio, there have been no material changes to our market risks in
the first nine months of fiscal year 2011, 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
that we receive on sales of RISPERDAL CONSTA by Janssen 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, 2010. 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
2011.
Item 4. Controls and Procedures
a) Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, evaluated the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended,
(the Exchange Act)) at December 31, 2010. Based on that evaluation, our Chief Executive Officer
and Chief Financial Officer concluded that our disclosure controls and procedures were effective as
of December 31, 2010 to provide reasonable assurance that the information required to be disclosed
by us in the reports that we file under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms and that such information
is accumulated and communicated to our management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In
designing and evaluating our disclosure controls and procedures, our management recognized that any
controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives, and our
25
management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and
procedures.
b) Change in Internal Control over Financial Reporting
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.
26
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 do not believe that we are currently party to 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
On November 21, 2007, our board of directors authorized a program to repurchase up to $175.0
million of our common stock to be repurchased at the discretion of management from time to time in
the open market or through privately negotiated transactions. On June 16, 2008, the board of
directors authorized the expansion of this program to $215.0 million. We did not purchase any
shares under this program during the quarter ended December 31, 2010. As of December 31, 2010, we
have 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, 2010, we acquired, by means of net share
settlements, 25,022 shares of Alkermes common stock at an average price of $11.41 per share related
to the vesting of employee stock awards to satisfy employee withholding tax obligations.
Item 5. Other Information
The Companys policy governing transactions in its securities by its directors, officers and
employees permits its officers, directors and employees to enter into trading plans in accordance
with Rule 10b5-1 under the Exchange Act. During the quarter ended December 31, 2010, Mr. James M.
Frates, an executive officer of the Company, entered 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.
Item 6. 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). |
|
|
|
101
|
|
The following materials from Alkermes, Inc.s Quarterly Report
on Form 10-Q for the quarter ended December 31, 2010,
formatted in XBRL (Extensible Business Reporting Language): |
|
|
(i) the Condensed Consolidated Balance Sheets, (ii) the
Condensed Consolidated Statements of Operations, (iii) the
Condensed Consolidated Statements of Cash Flows, and (iv) the
Notes to the Condensed Consolidated Financial Statements,
tagged as blocks of text (furnished herewith). |
27
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
|
|
|
|
Chairman, President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ James M. Frates
|
|
|
|
Senior Vice President, |
|
|
|
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
|
|
Date: February 3, 2011
28