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, 2008
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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.) |
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88 Sidney Street, Cambridge, MA
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02139-4234 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number including area code:
(617) 494-0171
(Former name, former address, and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, 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 |
Class |
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February 2, 2009 |
Common Stock, $.01 par value |
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94,501,982 |
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Non-Voting Common Stock, $.01 par value |
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382,632 |
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ALKERMES, INC. AND SUBSIDIARIES
INDEX
2
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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December 31, |
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March 31, |
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2008 |
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2008 |
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(In thousands, except share and |
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per share amounts) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
63,264 |
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$ |
101,241 |
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Investments short-term |
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281,464 |
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240,064 |
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Receivables |
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26,713 |
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47,249 |
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Inventory |
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21,113 |
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18,884 |
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Prepaid expenses and other current assets |
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14,920 |
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5,720 |
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Total current assets |
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407,474 |
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413,158 |
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PROPERTY, PLANT AND EQUIPMENT: |
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Land |
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301 |
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301 |
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Building and improvements |
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36,460 |
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35,003 |
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Furniture, fixtures and equipment |
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65,148 |
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63,364 |
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Equipment under capital lease |
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464 |
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464 |
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Leasehold improvements |
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33,711 |
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33,387 |
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Construction in progress |
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41,735 |
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42,859 |
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177,819 |
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175,378 |
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Less: accumulated depreciation |
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(70,520 |
) |
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(62,839 |
) |
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Total property, plant and equipment net |
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107,299 |
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112,539 |
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INVESTMENTS LONG-TERM |
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78,865 |
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119,056 |
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OTHER ASSETS |
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3,029 |
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11,558 |
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TOTAL ASSETS |
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$ |
596,667 |
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$ |
656,311 |
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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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$ |
30,310 |
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$ |
36,046 |
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Unearned milestone revenue current portion |
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5,927 |
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Deferred revenue current portion |
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11,705 |
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Long-term debt current portion |
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47 |
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Non-recourse RISPERDAL CONSTA secured 7% notes current portion |
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23,750 |
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Total current liabilities |
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65,765 |
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42,020 |
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NON-RECOURSE RISPERDAL CONSTA SECURED 7% NOTES |
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68,692 |
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160,324 |
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UNEARNED MILESTONE REVENUE LONG-TERM PORTION |
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111,730 |
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DEFERRED REVENUE LONG-TERM PORTION |
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5,369 |
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27,837 |
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OTHER LONG-TERM LIABILITIES |
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7,272 |
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9,086 |
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TOTAL LIABILITIES |
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147,098 |
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350,997 |
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COMMITMENTS AND CONTINGENCIES (Note 13) |
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SHAREHOLDERS EQUITY: |
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Capital stock, par value, $0.01 per share; 4,550,000 shares authorized (includes 3,000,000 shares
of preferred stock); none issued and outstanding |
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Common stock, par value, $0.01 per share; 160,000,000 shares authorized; 104,020,561
and 102,977,348 shares issued; 94,516,877 and 95,099,166 shares
outstanding at December 31, 2008 and March 31, 2008, respectively |
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1,040 |
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1,030 |
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Non-voting common stock, par value, $0.01 per share; 450,000 shares authorized;
382,632 shares issued and outstanding at December 31, 2008 and March 31, 2008 |
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4 |
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4 |
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Treasury stock, at cost (9,503,684 and 7,878,182 shares at December 31, 2008 and March 31, 2008,
respectively) |
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(125,978 |
) |
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(107,322 |
) |
Additional paid-in-capital |
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888,811 |
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869,695 |
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Accumulated other comprehensive loss |
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(1,841 |
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(1,526 |
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Accumulated deficit |
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(312,467 |
) |
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(456,567 |
) |
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TOTAL SHAREHOLDERS EQUITY |
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449,569 |
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305,314 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
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$ |
596,667 |
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$ |
656,311 |
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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 INCOME
(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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2008 |
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2007 |
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2008 |
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2007 |
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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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$ |
20,533 |
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$ |
14,275 |
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$ |
92,182 |
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$ |
69,929 |
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Royalty revenues |
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7,970 |
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7,384 |
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24,990 |
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21,714 |
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Research and development revenue under
collaborative arrangements |
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3,736 |
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23,985 |
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40,438 |
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68,641 |
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Net collaborative profit |
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123,422 |
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5,127 |
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125,354 |
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18,025 |
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Total revenues |
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155,661 |
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50,771 |
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282,964 |
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178,309 |
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EXPENSES: |
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Cost of goods sold |
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5,536 |
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7,499 |
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31,921 |
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26,862 |
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Research and development |
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22,669 |
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30,395 |
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64,640 |
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91,331 |
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Selling, general and adminstrative |
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14,568 |
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15,249 |
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38,173 |
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45,136 |
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Total expenses |
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42,773 |
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53,143 |
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134,734 |
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163,329 |
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OPERATING INCOME (LOSS) |
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112,888 |
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(2,372 |
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148,230 |
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14,980 |
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OTHER (EXPENSE) INCOME: |
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Gain on sale of investment in Reliant
Pharmaceuticals, Inc. |
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174,631 |
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174,631 |
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Interest income |
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2,574 |
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4,292 |
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8,883 |
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12,940 |
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Interest expense |
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(2,436 |
) |
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(4,088 |
) |
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(10,905 |
) |
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(12,238 |
) |
Other (expense) income |
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(641 |
) |
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(393 |
) |
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(1,471 |
) |
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784 |
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Total other (expense) income |
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(503 |
) |
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174,442 |
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(3,493 |
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176,117 |
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INCOME BEFORE INCOME TAXES |
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112,385 |
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172,070 |
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144,737 |
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191,097 |
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INCOME TAX (BENEFIT) PROVISION |
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(330 |
) |
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3,189 |
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637 |
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5,771 |
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NET INCOME |
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$ |
112,715 |
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$ |
168,881 |
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$ |
144,100 |
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$ |
185,326 |
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EARNINGS PER COMMON SHARE: |
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BASIC |
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$ |
1.18 |
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$ |
1.66 |
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$ |
1.51 |
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$ |
1.82 |
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DILUTED |
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$ |
1.18 |
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$ |
1.63 |
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$ |
1.49 |
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$ |
1.78 |
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WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING: |
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BASIC |
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95,316 |
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101,703 |
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95,246 |
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101,676 |
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DILUTED |
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95,818 |
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103,914 |
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96,398 |
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104,097 |
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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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December 31, |
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2008 |
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2007 |
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(In thousands) |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net income |
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$ |
144,100 |
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$ |
185,326 |
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Adjustments to reconcile net income to cash flows from operating activities: |
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Share-based compensation |
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11,590 |
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15,477 |
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Depreciation |
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|
7,501 |
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|
9,380 |
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Other non-cash charges |
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4,531 |
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|
4,225 |
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Loss on the purchase of non-recourse RISPERDAL CONSTA 7% Notes |
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1,989 |
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Gain on sale of investment in Reliant Pharmaceuticals, Inc. |
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(174,631 |
) |
Change in the fair value of warrants |
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(1,425 |
) |
Changes in assets and liabilities: |
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Receivables |
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11,585 |
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|
14,368 |
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Inventory, prepaid expenses and other assets |
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(4,746 |
) |
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(7,904 |
) |
Accounts payable and accrued expenses |
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(4,722 |
) |
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(14,004 |
) |
Unearned milestone revenue |
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(117,657 |
) |
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(9,537 |
) |
Deferred revenue |
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(9,529 |
) |
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|
6,909 |
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Other liabilities |
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(1,415 |
) |
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(180 |
) |
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Cash flows provided by operating activities |
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43,227 |
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28,004 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchases of property, plant and equipment |
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(4,145 |
) |
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(17,618 |
) |
Sales of property, plant and equipment |
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7,717 |
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Purchases of investments |
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(543,408 |
) |
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(371,342 |
) |
Sales and maturities of investments |
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|
540,721 |
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|
453,403 |
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Proceeds from the sale of investment in Reliant Pharmaceuticals, Inc. |
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|
166,865 |
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Cash flows provided by investing activities |
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|
885 |
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|
231,308 |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of common stock |
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|
7,606 |
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|
9,510 |
|
Excess tax benefit from stock options |
|
|
75 |
|
|
|
211 |
|
Payment of debt |
|
|
(47 |
) |
|
|
(975 |
) |
Purchase of non-recourse RISPERDAL CONSTA secured 7% Notes |
|
|
(71,775 |
) |
|
|
|
|
Purchase of treasury stock |
|
|
(17,948 |
) |
|
|
(27,627 |
) |
|
|
|
|
|
|
|
Cash flows used in financing activities |
|
|
(82,089 |
) |
|
|
(18,881 |
) |
|
|
|
|
|
|
|
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
(37,977 |
) |
|
|
240,431 |
|
CASH AND CASH EQUIVALENTS Beginning of period |
|
|
101,241 |
|
|
|
80,500 |
|
|
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CASH AND CASH EQUIVALENTS End of period |
|
$ |
63,264 |
|
|
$ |
320,931 |
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SUPPLEMENTAL CASH FLOW DISCLOSURE: |
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Cash paid for interest |
|
$ |
7,663 |
|
|
$ |
9,004 |
|
|
|
|
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Cash paid for income taxes |
|
$ |
435 |
|
|
$ |
980 |
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Non-cash investing and financing activities: |
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|
|
|
|
|
|
Purchased capital expenditures included in accounts payable and accrued expenses |
|
$ |
1,883 |
|
|
$ |
328 |
|
|
|
|
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|
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|
Net share exercise of warrants into common stock of the issuer |
|
$ |
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|
|
$ |
2,994 |
|
|
|
|
|
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|
|
Receipt of Alkermes shares for the purchase of stock options or as payment to satisfy
minimum withholding tax obligations related to stock based awards |
|
$ |
707 |
|
|
$ |
1,480 |
|
|
|
|
|
|
|
|
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. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business
Alkermes, Inc. (the Company) is a fully integrated biotechnology company committed to
developing innovative medicines to improve patients lives. Alkermes developed, manufactures and
commercializes VIVITROL® for alcohol dependence and manufactures RISPERDAL®
CONSTA® for schizophrenia. Alkermes pipeline includes extended-release injectable,
pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central
nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts,
Alkermes has research facilities in Massachusetts and a commercial manufacturing facility in Ohio.
Basis of Presentation
The accompanying condensed consolidated financial statements of the Company for the three and
nine months ended December 31, 2008 and 2007 are unaudited and have been prepared on a basis
substantially consistent with the audited financial statements for the year ended March 31, 2008.
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 (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, 2008, as filed with the Securities and Exchange
Commission (SEC).
The results of the Companys operations for any interim period are not necessarily indicative
of the results of the Companys operations for any other interim period or for a full fiscal year.
Principles of Consolidation
The condensed consolidated financial statements include the accounts of Alkermes, Inc. and its
wholly-owned subsidiaries: Alkermes Controlled Therapeutics, Inc.; Alkermes Europe, Ltd. and RC
Royalty Sub LLC (Royalty Sub). The assets of Royalty Sub are not available to satisfy obligations
of Alkermes and its subsidiaries, other than the obligations of Royalty Sub, including Royalty
Subs non-recourse RISPERDAL CONSTA secured 7% notes (the 7% Notes). 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.
Revenue Recognition
The Company recognizes revenue from the sale of VIVITROL in accordance with the Securities and
Exchange Commissions Staff Accounting Bulletin No. 101, Revenue Recognition in Financial
Statements (SAB 101), as amended by SEC Staff Accounting Bulletin No. 104, Revenue Recognition
(SAB 104). Specifically, revenue is recognized when persuasive evidence of an arrangement exists,
delivery has occurred and title to the product and associated risk of loss has passed to the
customer, the sales price is fixed or determinable, and collectibility is reasonably assured.
The Company sells VIVITROL primarily to wholesalers, distributors and specialty pharmacies. In
accordance with Statement of Financial Accounting Standards (SFAS) No. 48, Revenue Recognition
When Right of Return Exists (SFAS No. 48), the Company cannot recognize revenue on product
shipments until it can reasonably estimate returns related to these shipments. The Company defers
the recognition of revenue on shipments of VIVITROL to its customers until the product has left the
distribution channel. The Company estimates product shipments out of the distribution channel
through data provided by external sources,
6
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
including information on inventory levels provided by its wholesalers, specialty distributor
and specialty pharmacies, as well as prescription information. In order to match the cost of goods
related to products shipped to customers with the associated revenue, the Company is deferring the
recognition of the cost of goods to the period in which the
associated revenue is recognized.
In connection with the termination of the collaboration agreement with Cephalon, Inc.
(Cephalon) as discussed in Note 2, Collaborations, the Company recognized $120.7 million of net
collaborative profit, consisting of $113.9 million of
unearned milestone revenue and $6.8 million of deferred revenue
remaining on the Companys books at December 1, 2008 (the Termination
Date). At the Termination Date, the Company had
$22.8 million of deferred revenue related to the original sale
of the two partially completed VIVITROL manufacturing lines to
Cephalon. The Company paid Cephalon $16.0 million to reacquire
the title to these manufacturing lines and accounted for the payment
as a reduction to the deferred revenue previously recognized. The
remaining $6.8 million of deferred revenue and the
$113.9 million of unearned milestone revenue were recognized in the three months ended December 31, 2008, through net
collaborative profit, as the Company had no remaining performance obligations to Cephalon beyond
the Termination Date, and the amounts were nonrefundable to Cephalon. The Company received $11.0
million from Cephalon as payment to fund their share of estimated VIVITROL product losses during
the one-year period following the Termination Date, and the Company is recognizing this payment as
revenue through the application of a proportional performance model based on VIVITROL net product
losses.
New Accounting Pronouncements
In November 2007, the Emerging Issues Task Force (EITF) of the Financial Accounting
Standards Board (FASB) reached a final consensus on EITF Issue No. 07-1, Accounting for
Collaborative Arrangements Related to the Development and Commercialization of Intellectual
Property (EITF No. 07-1). EITF No. 07-1 is effective for the Companys fiscal year beginning
April 1, 2009. Adoption is on a retrospective basis to all prior periods presented for all
collaborative arrangements existing as of the effective date. The Company is currently evaluating
the impact of the adoption of EITF No. 07-1 on its consolidated financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities (SFAS No. 161). SFAS No. 161 is intended to improve financial reporting about
derivative instruments and hedging activities by requiring enhanced disclosures to enable investors
to better understand their effects on an entitys financial position, financial performance and
cash flows. SFAS No. 161 is effective for the Companys fiscal year beginning April 1, 2009, and
the Company does not expect the adoption of this standard to have a material impact on its
consolidated financial statements.
2. COLLABORATIONS
In November 2008, the Company and Cephalon agreed to end the collaboration for the
development, supply and commercialization of certain products, including VIVITROL in the U.S., effective December 1, 2008, and the Company assumed the
risks and responsibilities for the marketing and sale of VIVITROL in the U.S. The Company paid
Cephalon $16.0 million for title to two partially completed VIVITROL manufacturing lines, and the
Company received $11.0 million from Cephalon as payment to fund their share of estimated VIVITROL
product losses during the one-year period following the Termination Date. As of the Termination
Date, the Company is responsible for all VIVITROL profits or losses and Cephalon has no rights to
royalty payments on future sales of VIVITROL. For a period of six months following the Termination
Date, in order to facilitate the transfer of commercialization of VIVITROL to the Company,
Cephalon, at the Companys option, performs certain transition services on behalf of the
Company. Cephalon provides the Company with transition services at a full-time equivalent rate
(FTE) agreed to by the parties.
7
3. COMPREHENSIVE INCOME
Comprehensive income for the three and nine months ended December 31, 2008 and 2007 is as
follows:
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income |
|
$ |
112,715 |
|
|
$ |
168,881 |
|
|
$ |
144,100 |
|
|
$ |
185,326 |
|
Unrealized losses on available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Holding losses |
|
|
(1,212 |
) |
|
|
(1,469 |
) |
|
|
(1,478 |
) |
|
|
(2,019 |
) |
Reclassification of unrealized losses to realized losses on
available-for-sale securities |
|
|
556 |
|
|
|
337 |
|
|
|
1,163 |
|
|
|
337 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses on available-for-sale securities |
|
|
(656 |
) |
|
|
(1,132 |
) |
|
|
(315 |
) |
|
|
(1,682 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
112,059 |
|
|
$ |
167,749 |
|
|
$ |
143,785 |
|
|
$ |
183,644 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4. EARNINGS PER COMMON SHARE
Basic earnings per common share is calculated based upon net income available to holders of
common shares divided by the weighted average number of shares outstanding. For the calculation of
diluted earnings per common share, the Company uses the weighted average number of common shares
outstanding, as adjusted for the effect of potential outstanding shares, including stock options
and restricted stock units.
Basic and diluted earnings per common share are calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
112,715 |
|
|
$ |
168,881 |
|
|
$ |
144,100 |
|
|
$ |
185,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
95,316 |
|
|
|
101,703 |
|
|
|
95,246 |
|
|
|
101,676 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
446 |
|
|
|
2,159 |
|
|
|
974 |
|
|
|
2,354 |
|
Restricted stock units |
|
|
56 |
|
|
|
52 |
|
|
|
178 |
|
|
|
67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive common share equivalents |
|
|
502 |
|
|
|
2,211 |
|
|
|
1,152 |
|
|
|
2,421 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted earnings per share |
|
|
95,818 |
|
|
|
103,914 |
|
|
|
96,398 |
|
|
|
104,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options of 16.4 million and 11.9 million for the three months ended December 31, 2008
and 2007, respectively, and 15.4 million and 11.9 million for the nine months ended December 31,
2008 and 2007, respectively, were not included in the calculation of earnings per common share
because their effects are anti-dilutive. There were 0.6 million and no restricted stock units
excluded from the calculation of net income per common share for the three months ended December
31, 2008 and 2007, respectively, and less than 0.1 million and none for the nine months ended
December 31, 2008 and 2007, respectively, because their effects are anti-dilutive.
5. INVESTMENTS
Investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2008 |
|
|
2008 |
|
Current investments: |
|
|
|
|
|
|
|
|
Available-for-sale |
|
$ |
281,464 |
|
|
$ |
240,064 |
|
Long-term investments: |
|
|
|
|
|
|
|
|
Available-for-sale |
|
|
74,212 |
|
|
|
114,403 |
|
Held-to-maturity |
|
|
4,653 |
|
|
|
4,653 |
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
78,865 |
|
|
|
119,056 |
|
|
|
|
|
|
|
|
Total investments |
|
$ |
360,329 |
|
|
$ |
359,120 |
|
|
|
|
|
|
|
|
8
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Companys available-for-sale investments are carried at fair value in the Companys
condensed consolidated balance sheets and include U.S. government and agency debt securities,
investment grade corporate debt securities, including asset backed
debt securities and student loan
backed auction rate securities, and strategic equity investments, which are investments in certain
publicly traded companies. The Companys held-to-maturity securities are carried at amortized cost
and include U.S. government debt securities and corporate debt securities that are restricted and
held as collateral under certain letters of credit related to certain of the Companys lease
agreements.
At December 31, 2008, the Company had gross unrealized gains of $4.0 million and gross
unrealized losses of $5.8 million on its available-for-sale investments. The Company believes that
the gross unrealized losses on these investments are temporary, and the Company has the intent and
ability to hold these securities to recovery, which may be at maturity. For the nine months ended
December 31, 2008, the Company recognized $1.2 million in charges for other-than-temporary losses
on its strategic equity investments.
At December 31, 2008, the Company had $10.0 million in investments in auction rate securities
with an unrealized loss of $1.1 million. The securities represent the Companys investment in
taxable student loan revenue bonds issued by state higher education authorities which service
student loans under the Federal Family Education Loan Program. The bonds were triple A rated at the
date of purchase and are collateralized by student loans purchased by the authorities, which are
guaranteed by state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity
for these securities is typically provided by an auction process that resets the applicable
interest rate at pre-determined intervals. Each of these securities had been subject to auction
processes for which there had been insufficient bidders on the scheduled auction dates and the
auctions subsequently failed. The Company is not able to liquidate its investments in auction rate
securities until future auctions are successful, a buyer is found outside of the auction process or
the bonds are redeemed by the issuer. The securities continue to pay interest at predetermined
interest rates during the periods in which the auctions have failed. At December 31, 2008, the
Company determined that the securities were temporarily impaired due to the length of time each
security was in an unrealized loss position, the extent to which fair value was less than cost, the
financial condition and near term prospects of the issuers and the guarantee agencies, and the
Companys intent and ability to hold each security for a period of time sufficient to allow for any
anticipated recovery in fair value.
At December 31, 2008, the Company had $7.5 million in investments in asset backed debt
securities with an unrealized loss of $0.9 million. The securities represent the Companys
investment in investment grade medium term floating rate notes (MTN) of Aleutian Investments, LLC
(Aleutian) and Meridian Funding Company, LLC (Meridian), which are qualified special purpose
entities (QSPEs) of Ambac Financial Group, Inc. (Ambac) and MBIA, Inc. (MBIA), respectively.
Ambac and MBIA are guarantors of financial obligations and are referred to as monoline financial
guarantee insurance companies. The QSPEs, which purchase pools of assets or securities and fund
the purchase through the issuance of MTNs, have been established to provide a vehicle to access
the capital markets for asset backed debt securities and corporate borrowers. The MTNs include
sinking fund redemption features which match-fund the terms of redemptions to the maturity dates of
the underlying pools of assets or securities in order to mitigate potential liquidity risk to the
QSPEs. At December 31, 2008, a portion of the Companys initial investment in the Meridian MTNs
had been redeemed by MBIA through scheduled sinking fund redemptions at par value, and the first
sinking fund redemption on the Aleutian MTN is scheduled for June 2009.
The liquidity and fair value of these securities has been negatively impacted by the
uncertainty in the credit markets, and the exposure of these securities to the financial condition
of monoline financial guarantee insurance companies, including Ambac and MBIA. In June 2008, Ambac
had its triple A rating reduced to Aa3 by Moodys and in November, Moodys further downgraded
Ambacs rating to Baa1 with a developing outlook. Standard and Poors (S&P) reduced Ambacs
rating to double A in June 2008 and in August 2008, affirmed its double A rating with a negative
outlook. In June 2008, MBIA was downgraded from triple A to A2 by Moodys and in September Moodys
placed MBIA on review for possible downgrade. S&P reduced MBIAs rating to double A in June 2008
and in August 2008, affirmed its double A rating with a negative outlook. All downgrades were due
to Ambacs and MBIAs inability to maintain triple A capital levels.
The Company may not be able to liquidate its investment in these securities before the
scheduled redemptions or until trading in the securities resumes in the credit markets, which may
not occur. At December 31, 2008, the Company determined that the securities had been temporarily
impaired due to the length of time each security was in an unrealized loss position, the extent to
which fair value was less than cost, the financial condition and near term prospects of the
issuers, current redemptions made by one of the issuers and the Companys intent and ability to
hold each security for a period of time sufficient to allow for any anticipated recovery in fair
value or until scheduled redemption.
9
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Company also holds a warrant to purchase securities of a certain publicly held company
included in its portfolio of strategic equity investments. This warrant is considered to be a
derivative instrument, and at December 31, 2008 and March 31, 2008 the carrying value of the
warrant was immaterial.
6. FAIR VALUE MEASUREMENTS
Effective April 1, 2008, the Company implemented SFAS No. 157, Fair Value Measurements
(SFAS No. 157) for its financial assets and liabilities that are re-measured and reported at fair
value at each reporting period. The adoption of SFAS No. 157 did not have a material impact on the
Companys financial position and results of operations. In accordance with the provisions of FASB
Staff Position FAS 157-2, Effective Date of FASB Statement No. 157 (FSP FAS 157-2), the Company
has elected to defer implementation of SFAS No. 157 as it relates to non-financial assets and
non-financial liabilities that are recognized and disclosed at fair value in the financial
statements on a nonrecurring basis until April 1, 2009. The Company is evaluating the impact, if
any, this standard will have on its non-financial assets and liabilities.
SFAS No. 157 provides a framework for measuring fair value and requires expanded disclosures
regarding fair value measurements. SFAS No. 157 defines fair value as the price that would be
received to sell an asset or paid to transfer a liability (the exit price) in an orderly
transaction between market participants at the measurement date. In determining fair value, SFAS
No. 157 permits the use of various valuation approaches, including market, income and cost
approaches. SFAS No. 157 establishes a hierarchy for inputs used in measuring fair value that
maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available. In October 2008, the FASB issued FASB Staff
Position FAS 157-3 Determining the Fair Value of a Financial Asset When the Market for that Asset
is not Active (FSP FAS 157-3). FSP FAS 157-3 clarifies the application of SFAS No. 157 in a
market that is not active and provides an example to illustrate key considerations in determining
the fair value of a financial asset when the market for that financial asset is not active. FSP FAS
157-3 was effective for the Companys condensed consolidated
financial statements for the quarter ended September 30, 2008. The adoption of this standard did not have a material impact
on the consolidated financial statements.
The fair value hierarchy is broken down into three levels based on the reliability of inputs.
The Company has categorized its cash, cash equivalents and investments within the hierarchy as
follows:
Level 1 - These valuations are based on a market approach using quoted prices in active
markets for identical assets. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 1 inputs include investments in money market funds, U.S.
government and agency debt securities, bank deposits and exchange-traded equity securities of
certain publicly held companies;
Level 2 - These valuations are based on a market approach using quoted prices obtained from
brokers or dealers for similar securities or for securities for which we have limited visibility
into their trading volumes. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 2 inputs consist of investments in
corporate debt securities; and
Level 3 - These valuations are based on an income approach using certain inputs that are
unobservable and are significant to the overall fair value measurement. Valuations of these
products require a significant degree of judgment. Assets utilizing Level 3 inputs consist of
investments in auction rate securities and asset backed debt securities that are not currently
trading. In addition, the Company holds a warrant in a certain publicly held company that is
classified using Level 3 inputs. The carrying balance of this warrant was immaterial at December
31, 2008 and March 31, 2008.
10
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table presents information about the Companys assets that are measured at fair
value on a recurring basis at December 31, 2008, and indicates the fair value hierarchy of the
valuation techniques the Company utilized to determine such fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
|
|
|
(In thousands) |
|
2008 |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Cash equivalents |
|
$ |
1,163 |
|
|
$ |
1,163 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency debt securities |
|
|
267,565 |
|
|
|
267,565 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
76,504 |
|
|
|
4,240 |
|
|
|
72,264 |
|
|
|
|
|
Asset backed debt securities |
|
|
6,607 |
|
|
|
|
|
|
|
|
|
|
|
6,607 |
|
Auction rate securities |
|
|
8,858 |
|
|
|
|
|
|
|
|
|
|
|
8,858 |
|
Strategic equity investments |
|
|
795 |
|
|
|
795 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
361,492 |
|
|
$ |
273,763 |
|
|
$ |
72,264 |
|
|
$ |
15,465 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair values of the Companys investments in asset backed debt securities and auction rate
securities are determined using certain inputs that are unobservable and significant to the overall
fair value measurement. Typically, auction rate securities trade at their par value due to the
short interest rate reset period and the availability of buyers or sellers of the securities at
recurring auctions. However, since the security auctions have failed and fair value cannot be
derived from quoted prices, the Company used a discounted cash flow model to determine the
estimated fair value of its investments in auction rate securities at December 31, 2008. The
Company also used a discounted cash flow model to determine the estimated fair value of its
investments in asset backed debt securities at December 31, 2008, as the asset backed debt
securities are not actively trading. The assumptions used in the discounted cash flow models used
to determine the estimated fair value of these securities include estimates for interest rates,
timing of cash flows, expected holding periods and risk adjusted discount rates, which include a
provision for default and liquidity risk. The Companys valuation analyses consider, among other
items, assumptions that market participants would use in their estimates of fair value, such as the
collateral underlying the security, the inability to sell the investment in an active market, the
creditworthiness of the issuer and any associated guarantees, the timing of expected future cash
flows, and the expectation of the next time the security will have a successful auction or when
callability features may be exercised by the issuer. These securities were also compared, where
possible, to other observable market data with similar characteristics.
The following table is a rollforward of the fair value of the Companys investments in asset
backed debt securities and auction rate securities whose fair value is determined using Level 3
inputs:
|
|
|
|
|
(In thousands) |
|
Fair Value |
|
Balance, April 1, 2008 |
|
$ |
18,612 |
|
Total unrealized losses included in earnings |
|
|
|
|
Total unrealized losses included in comprehensive income |
|
|
(902 |
) |
Redemptions, at par value |
|
|
(2,245 |
) |
|
|
|
|
Balance, December 31, 2008 |
|
$ |
15,465 |
|
|
|
|
|
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS
No. 159 permits, but does not require, entities to elect to measure selected financial instruments
and certain other items at fair value. Unrealized gains and losses on items for which the fair
value option has been elected are recognized in earnings at each reporting period. The Company
adopted the provisions of SFAS No. 159 on April 1, 2008 and did not elect to measure any new assets
or liabilities at their respective fair values and, therefore, the adoption of SFAS No. 159 did not
have an impact on its results of operations and financial position.
11
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. 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) |
|
2008 |
|
|
2008 |
|
Raw materials |
|
$ |
7,699 |
|
|
$ |
8,373 |
|
Work in process |
|
|
5,261 |
|
|
|
3,060 |
|
Finished goods |
|
|
6,917 |
|
|
|
7,451 |
|
Consigned-out inventory |
|
|
1,236 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
21,113 |
|
|
$ |
18,884 |
|
|
|
|
|
|
|
|
8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In thousands) |
|
2008 |
|
|
2008 |
|
Accounts payable |
|
$ |
5,364 |
|
|
$ |
7,042 |
|
Accrued compensation |
|
|
9,211 |
|
|
|
11,245 |
|
Accrued interest |
|
|
1,662 |
|
|
|
2,975 |
|
Accrued restructuring current portion |
|
|
771 |
|
|
|
4,037 |
|
Accrued other |
|
|
13,302 |
|
|
|
10,747 |
|
|
|
|
|
|
|
|
Total |
|
$ |
30,310 |
|
|
$ |
36,046 |
|
|
|
|
|
|
|
|
9. RESTRUCTURING
In March 2008, the Company announced the decision by Eli Lilly and Company to discontinue the
AIR® Insulin development program. As a result, the Company terminated approximately 150
employees and closed its commercial manufacturing facility in Chelsea, MA (the 2008
Restructuring). In connection with the 2008 Restructuring, the Company recorded net restructuring
charges of $6.9 million in the year ended March 31, 2008. At December 31, 2008, the Company had
paid in cash approximately $3.8 million in connection with the 2008 Restructuring.
Restructuring activity during the nine months ended December 31, 2008 for the 2008
Restructuring is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facility |
|
|
|
|
|
|
Other Contract |
|
|
|
|
(In thousands) |
|
Closure |
|
|
Severance |
|
|
Losses |
|
|
Total |
|
Balance, April 1, 2008 |
|
$ |
4,930 |
|
|
$ |
2,881 |
|
|
$ |
37 |
|
|
$ |
7,848 |
|
Additions |
|
|
|
|
|
|
78 |
|
|
|
70 |
|
|
|
148 |
|
Payments |
|
|
(725 |
) |
|
|
(2,959 |
) |
|
|
(107 |
) |
|
|
(3,791 |
) |
Other adjustments |
|
|
149 |
|
|
|
|
|
|
|
|
|
|
|
149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2008 (1) |
|
$ |
4,354 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,354 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
At December 31, 2008, the restructuring liability consists of $0.8 million classified
as current and $3.6 million classified as long-term in the accompanying condensed
consolidated balance sheets. |
In June 2004, the Company and its former collaborative partner Genentech, Inc. announced the
decision to discontinue commercialization of NUTROPIN DEPOT® (the 2004 Restructuring).
In connection with the 2004 Restructuring, the Company recorded charges of $11.5 million in the
year ended March 31, 2005. During the six months ended September 30, 2008, the Company paid $0.1
million in facility closure costs and recorded an adjustment of $0.1 million to reduce the 2004
Restructuring liability to zero. As of September 30, 2008, the 2004 Restructuring was complete.
12
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. SHARE-BASED COMPENSATION
Share-based compensation expense for the three and nine months ended December 31, 2008 and
2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Cost of goods manufactured |
|
$ |
291 |
|
|
$ |
319 |
|
|
$ |
1,148 |
|
|
$ |
1,279 |
|
Research and development |
|
|
527 |
|
|
|
2,055 |
|
|
|
3,397 |
|
|
|
5,691 |
|
Selling, general and administrative |
|
|
2,463 |
|
|
|
2,808 |
|
|
|
7,045 |
|
|
|
8,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,281 |
|
|
$ |
5,182 |
|
|
$ |
11,590 |
|
|
$ |
15,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2008 and March 31, 2008, $0.2 million and $0.3 million, respectively, of
share-based compensation cost was capitalized and recorded as Inventory in the condensed
consolidated balance sheets.
11. EXTINGUISHMENT OF DEBT
In June and July 2008, the Company purchased, in three privately negotiated transactions,
$75.0 million in principal amount of its outstanding 7% Notes for $71.8 million. As a result of the
purchases, $95.0 million principal amount of the 7% Notes remains outstanding at December 31, 2008.
The Company recorded a loss on the extinguishment of the purchased 7% Notes of $2.0 million in the
six months ended September 30, 2008, which was recorded as interest expense.
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, 2008, 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 earned income before income taxes of $112.4 million and
$144.7 million during the
three and nine months ended December 31, 2008, respectively and the Company recorded an income tax
benefit of $0.3 million and an income tax provision of $0.6 million for the three and nine months
ended December 31, 2008, respectively. This variation in the customary relationship between income
earned before income taxes and the income tax provision is due to termination of the VIVITROL
collaboration with Cephalon as discussed in Note 2, Collaborations. The Company previously
recognized, for tax purposes, the milestone payments received from Cephalon under the VIVITROL
collaboration. The income tax benefit and provision recorded for the three and nine months ended
December 31, 2008, respectively, and the income tax provision of $3.2 million and $5.8 million for
the three and nine months ended December 31, 2007, respectively, related to the U.S. alternative
minimum tax (AMT). Included in the $0.6 million provision for the nine months ended December 31,
2008 is a $0.1 million estimated benefit as a result of the recently enacted Housing and Economic
Recovery Act of 2008. This legislation allows for certain taxpayers to forego bonus depreciation in
lieu of a refundable cash credit based on certain qualified asset purchases.
The utilization of tax loss carryforwards is limited in the calculation of AMT and, as a
result, a federal tax benefit was recorded in the three months ended
December 31, 2008, and a
federal tax charge was recorded in the nine months ended December 31, 2008 and in the three and
nine months ended December 31, 2007. The AMT liability is available as a credit against future tax
obligations upon the full utilization or expiration of the Companys net operating loss
carryforward.
13. COMMITMENTS AND CONTINGENCIES
From time to time, the Company may be subject to legal proceedings and claims in the ordinary
course of business. The Company is not aware of any such proceedings or claims that it believes
will have, individually or in the aggregate, a material adverse effect on its business, financial
condition or results of operations.
In November 2007, Reliant Pharmaceuticals, Inc. (Reliant) was acquired by GlaxoSmithKline
(GSK). Under the terms of the acquisition, the Company received $166.9 million upon the closing
of the transaction in December 2007 in exchange for the Companys investment in Series C
convertible, redeemable preferred stock of Reliant. The Company is entitled to receive up to an
additional $7.7 million of funds held in escrow subject to the terms of an escrow agreement between
GSK and Reliant. The escrowed funds represent the maximum potential amount of future payments that
may be payable to GSK under the terms of the escrow agreement, which is effective for a period of
15 months following the closing of the transaction. The Company has not recorded a liability
related to the indemnification to GSK, as the Company currently believes that it is remote that any
of the escrowed funds will be needed to indemnify GSK for any losses it might incur related to the
representations and warranties made by Reliant in connection with the acquisition.
13
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
14. 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 disease. The Companys chief decision
maker, the Chief Executive Officer, reviews the Companys operating results on an aggregate basis
and manages the Companys operations as a single operating unit.
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 developed, manufacture and commercialize
VIVITROL® for alcohol dependence and manufacture RISPERDAL®
CONSTA® for schizophrenia. Our robust pipeline includes extended-release injectable,
pulmonary and oral products for the treatment of prevalent, chronic diseases, such as central
nervous system disorders, addiction and diabetes. Headquartered in Cambridge, Massachusetts, we
have research facilities in Massachusetts and a commercial manufacturing facility in Ohio.
Forward-Looking Statements
Any statements herein or otherwise made in writing or orally by us with regard to our
expectations as to financial results and other aspects of our business may constitute
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, statements concerning future operating results, the
achievement of certain business and operating goals, manufacturing revenues, product sales and
royalty revenues, plans for clinical trials, regulatory approvals and manufacture and
commercialization of products and product candidates, spending relating to research and
development, manufacturing, and selling and marketing activities, financial goals and projections
of capital expenditures, recognition of revenues, and future financings. These statements relate to
our future plans, objectives, expectations and intentions and may be identified by words like
believe, expect, designed, may, will, should, seek, or anticipate, and similar
expressions.
Although we believe that our expectations are based on reasonable assumptions within the
bounds of our knowledge of our business and operations, the forward-looking statements contained in
this document are neither promises nor guarantees, and our business is subject to significant risk
and uncertainties and there can be no assurance that our actual results will not differ materially
from our expectations. These forward looking statements include, but are not limited to, statements
concerning: the achievement of certain business and operating milestones and future operating
results and profitability; continued growth of RISPERDAL CONSTA sales; the commercialization of
VIVITROL in the United States (U.S.) by us and in Russia and countries in the Commonwealth of
Independent States (CIS) by Cilag GmbH International (Cilag), a subsidiary of Johnson &
Johnson; recognition of milestone payments from Cilag related to the future sales of VIVITROL; the
successful continuation of development activities for our programs, including exenatide once
weekly, a four-week formulation of RISPERDAL CONSTA, VIVITROL for opiate dependence, ALKS 27, ALKS
29 and ALKS 33; the timeline for the NDA submission for exenatide
once weekly; the successful manufacture of our products and product candidates, including
RISPERDAL CONSTA and VIVITROL, by us at a commercial scale, and the successful manufacture of exenatide
once weekly by Amylin Pharmaceuticals, Inc. (Amylin); and
our building a successful commercial infrastructure for VIVITROL. Factors which could cause actual results to differ
materially from our expectations set forth in our forward-looking statements include, among others:
(i) manufacturing and royalty revenues from RISPERDAL CONSTA may not continue to grow, particularly
because we rely on our partner, Janssen Pharmaceutica, Inc., a division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag International
(together, Janssen), to forecast and market this product; (ii) we may be unable to manufacture
RISPERDAL CONSTA and VIVITROL in sufficient quantities and with sufficient yields to meet our
partners requirements or to add additional production capacity for RISPERDAL CONSTA and VIVITROL,
or unexpected events could interrupt manufacturing operations at our RISPERDAL CONSTA and VIVITROL
manufacturing facility, which is the sole source of supply for these products; (iii) we may be
unable to develop the commercial capabilities, and/or infrastructure, necessary to
successfully commercialize VIVITROL; (iv) Cilag may be unable to receive approval for VIVITROL for
the treatment of opioid dependence in Russia and for the treatment of alcohol and opioid dependence
in the other countries in the CIS; (v) Cilag may be unable to successfully commercialize VIVITROL;
(vi) third party payors may not cover or reimburse VIVITROL; (vii) we may be unable to scale-up and
manufacture our product candidates commercially or economically; (viii) we may not be able to
source raw materials for our production processes from third parties; (ix) Amylin may not be able
to successfully operate the manufacturing facility for exenatide once weekly and the U.S. Food and
Drug Administration (FDA) may not find the product produced in the Amylin facility comparable to
the product used in the pivotal clinical study which was produced in our facility; (x) our product
candidates, if approved for marketing, may not be launched successfully in one or all indications
for which marketing is approved and, if launched, may not produce significant revenues; (xi) we
rely on our partners to determine the regulatory and marketing strategies for RISPERDAL CONSTA,
including the four-week formulation of RISPERDAL CONSTA currently being developed by us, and our
other partnered, non-proprietary programs; (xii) RISPERDAL CONSTA, VIVITROL and our product
candidates in commercial use may have unintended side effects, adverse reactions or incidents of
misuse and the FDA or other health authorities could require post approval studies or require
removal of our products from the market; (xiii) our collaborators could elect to terminate or delay
programs at any time and disputes with collaborators or failure to negotiate acceptable new
collaborative arrangements for our technologies could occur; (xiv) clinical trials may take more
time or consume more resources than initially envisioned; (xv) results of earlier clinical trials
may not necessarily be predictive of the safety and efficacy results in larger clinical trials;
(xvi) our product candidates could be ineffective or unsafe during
15
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; (xvii) after the
completion of clinical trials for our product candidates, including exenatide once weekly, or after
the submission for marketing approval of such product candidate, the FDA or other health
authorities could refuse to accept such filings, could request additional preclinical or clinical
studies be conducted or request a safety monitoring program, any of which could result in
significant delays or the failure of such product to receive marketing approval; (xviii) even if
our product candidates appear promising at an early stage of development, product candidates could
fail to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be
uneconomical, fail to achieve market acceptance, be precluded from commercialization by proprietary
rights of third parties or experience substantial competition in the marketplace; (xix)
technological change in the biotechnology or pharmaceutical industries could render our products
and/or product candidates obsolete or non-competitive; (xx) difficulties or set-backs in obtaining
and enforcing our patents and difficulties with the patent rights of others could occur; (xxi) we
may incur losses in the future; (xxvi) we may need to raise substantial additional funding to
continue research and development programs and clinical trials and other operations and could incur
difficulties or setbacks in raising such funds, which may be further
impacted by current economic conditions and the lack of available
credit sources; (xxii) we may not be able to liquidate or otherwise
recoup our investments in our asset backed debt securities and auction rate securities.
The forward-looking statements made in this document are made only as of the date hereof and
we do not intend to update any of these factors or to publicly announce the results of any
revisions to any of our forward-looking statements other than as required under the federal
securities laws.
Our Strategy
We leverage our unique formulation expertise and drug development technologies to develop,
both with partners and on our own, innovative and competitively advantaged drug products that
enhance patient outcomes in major therapeutic areas. We develop our own proprietary therapeutics by
applying our innovative formulation expertise and drug development capabilities to create new
pharmaceutical products. In addition, we enter into select collaborations with pharmaceutical and
biotechnology companies to develop significant new product candidates, based on existing drugs and
incorporating our technologies. Each of these approaches is discussed in more detail below.
Product Developments
RISPERDAL CONSTA
RISPERDAL CONSTA is a long-acting formulation of risperidone, a product of Janssen, and is the
first and only long-acting, FDA-approved atypical antipsychotic. The medication uses our
proprietary Medisorb® technology to deliver and maintain therapeutic medication levels
in the body through just one injection every two weeks. Schizophrenia is a brain disorder
characterized by disorganized thinking, delusions and hallucinations. Studies have demonstrated
that as many as 75 percent of patients with schizophrenia have difficulty taking their oral
medication on a regular basis, which can lead to worsening of symptoms. Clinical data has shown
that treatment with RISPERDAL CONSTA may lead to improvements in symptoms, sustained remission and
decreases in hospitalization. RISPERDAL CONSTA is marketed by Janssen and is exclusively
manufactured by us. RISPERDAL CONSTA was first approved by regulatory authorities in the United
Kingdom (UK) and Germany in August 2002 and the FDA in October 2003. RISPERDAL CONSTA is approved
in approximately 85 countries and marketed in approximately 60 countries, and Janssen continues to
launch the product around the world.
In April 2008, we announced that our partner, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for
RISPERDAL CONSTA to the FDA seeking approval for adjunctive maintenance treatment to delay the
occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD). FRBD
is defined as four or more manic or depressive episodes in the previous year that require a
doctors care. The condition may affect 10 to 20 percent of the estimated 27 million people
world-wide with bipolar disorder.
In May 2008, the results of a study sponsored by Janssen were presented at the American
Psychiatric Association (APA) 161st Annual Meeting in Washington D.C. This 24 - month,
open-label, active-controlled, international study investigated whether treatment with Risperidone
Long-Acting Injection (RLAI), compared with oral quetiapine when tested in a routine care setting
within general psychiatric services, had an effect on long-term efficacy maintenance as measured by
time to relapse in patients with schizophrenia. The results demonstrated that the average
relapse-free time was significantly longer in patients treated with RLAI (607 days) compared to
quetiapine (533 days) (p<0.0001). Furthermore, over the 24 - month treatment period, relapse
occurred in 16.5 percent of patients treated with RLAI and 31.3 percent in the quetiapine treatment
arm.
16
In July 2008, we announced that our partner J&JPRD submitted a sNDA for RISPERDAL CONSTA to
the FDA for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the
time to occurrence of mood episodes in adults. Bipolar disorder is a brain disorder that causes
unusual shifts in a persons mood, energy and ability to function. Characterized by debilitating
mood swings, from extreme highs (mania) to extreme lows (depression), bipolar I disorder affects an
estimated 5.7 million, or 2.6 percent, of the American adult population in any given year.
In October 2008, the FDA approved the deltoid muscle of the arm as a new injection site for
RISPERDAL CONSTA. RISPERDAL CONSTA was previously approved as a gluteal injection only.
In January 2009, we announced that J&JPRD initiated a phase 1, single-dose, open-label study
of a four-week formulation of RISPERDAL CONSTA for the treatment of schizophrenia. The study is
designed to assess the pharmacokinetics, safety and tolerability of a gluteal injection of this
risperidone formulation in approximately 26 patients diagnosed with chronic, stable schizophrenia.
VIVITROL
We developed VIVITROL, an extended-release Medisorb formulation of naltrexone, for the
treatment of alcohol dependence in patients who are able to abstain from drinking in an outpatient
setting and are not actively drinking prior to treatment initiation. Alcohol dependence is a
serious and chronic brain disease characterized by cravings for alcohol, loss of control over
drinking, withdrawal symptoms and an increased tolerance for alcohol. Adherence to medication is
particularly challenging with this patient population. In clinical trials, when used in combination
with psychosocial support, VIVITROL was shown to reduce the number of drinking days and heavy
drinking days and to prolong abstinence in patients who abstained from alcohol the week prior to
starting treatment. Each injection of VIVITROL provides medication for one month and alleviates the
need for patients to make daily medication dosing decisions. VIVITROL was approved by the FDA in
April 2006 and was launched in June 2006.
In April 2007, we submitted a Marketing Authorization Application (MAA) for VIVITROL for the
treatment of alcohol dependence to regulatory authorities in the UK and Germany based on the single
pivotal clinical study used to register VIVITROL in the U.S. In July 2008, based on feedback from
the UK health authorities that data from a single study would not be sufficient to register
VIVITROL in the UK and Germany, we withdrew the MAA.
In December 2007, we entered into an exclusive agreement with Cilag to commercialize VIVITROL
for the treatment of alcohol dependence and opioid dependence in Russia and other countries in the
CIS. In August 2008, we announced that Cilag received approval from the Russian regulatory
authority to market VIVITROL for the treatment of alcohol dependence. Janssen-Cilag, an affiliate
company of Cilag, will commercialize VIVITROL. We retain exclusive development and marketing rights
to VIVITROL in all markets outside Russia and other countries in the CIS. We are responsible for
manufacturing VIVITROL and will receive manufacturing fees and royalties based on product sales.
In June 2008, we initiated a randomized, multi-center registration study of VIVITROL in Russia
for the treatment of opioid dependence. The multi-center study is designed to assess the efficacy
and safety of VIVITROL in approximately 200 patients diagnosed with opioid dependence. The clinical
data from this study may form the basis of a sNDA to the FDA for VIVITROL for the treatment of
opioid dependence, a chronic brain disease.
In November 2008, we and Cephalon agreed to end the collaboration for the development, supply
and commercialization of certain products, including VIVITROL in the
U.S.,
effective December 1, 2008 (the Termination Date), and we assumed the risks and responsibilities
for the marketing and sale of VIVITROL in the U.S. We paid Cephalon $16.0 million for title to two
partially completed VIVITROL manufacturing lines, and we received $11.0 million from Cephalon as
payment to fund their share of estimated VIVITROL product losses during the one-year period
following the Termination Date. As of the Termination Date, Cephalon is no longer responsible for
the marketing and sale of VIVITROL in the U.S., and we are responsible for all VIVITROL profits or
losses. Cephalon has no rights to royalty payments on future sales of VIVITROL. For a period
of six months following the Termination Date, in order to facilitate the transfer of
commercialization of VIVITROL to us, Cephalon, at our option, performs certain transition
services on our behalf. Cephalon provides us with transition services at a full-time equivalent
rate (FTE) agreed to by the parties.
17
Exenatide Once Weekly
We are collaborating with Amylin on the development of exenatide once weekly for the treatment
of type 2 diabetes. Exenatide once weekly is an injectable formulation of Amylins
BYETTA® (exenatide) which is an injection administered twice daily. Diabetes is a
disease in which the body does not produce or properly use insulin. Diabetes can result in serious
health complications, including cardiovascular, kidney and nerve disease. BYETTA was approved by
the FDA in April 2005 as adjunctive therapy to improve blood sugar control in patients with type 2
diabetes who have not achieved adequate control on metformin and/or sulfonylurea; two commonly used
oral diabetes medications. In December 2006, the FDA approved BYETTA as an add-on therapy for
people with type 2 diabetes unable to achieve adequate glucose control on thiazolidinedione, a
class of diabetes medications. Amylin has an agreement with Eli Lilly and Company (Lilly) for the
development and commercialization of exenatide, including exenatide once weekly. Exenatide once
weekly is being developed with the goal of providing patients with an effective and more
patient-friendly treatment option.
In June 2008, we, Amylin and Lilly announced positive results from a 52-week, open-label
clinical study (DURATION-1 study) that showed the durable efficacy of exenatide once weekly. At
52 weeks, patients taking exenatide once weekly showed an average A1C improvement of 2 percent and
an average weight loss of 9.5 pounds. The study also showed that patients who switched from BYETTA
injection after 30 weeks to exenatide once weekly experienced additional improvements in A1C and
fasting plasma glucose. 74 percent of all patients in the study achieved an endpoint of A1C of 7
percent or less at 52 weeks. Exenatide once weekly was well tolerated, with no major hypoglycemia
events regardless of background therapy and nausea was predominantly mild and transient.
In
November 2008, we announced that Amylin had received feedback from the FDA that the data it
submitted from its in vitro in vivo correlation studies to demonstrate comparability between
exenatide once weekly manufactured by us in our facility, and used in previous clinical studies,
and exenatide once weekly manufactured on a commercial scale in Amylins Ohio facility did not meet
FDA requirements. In December 2008, the FDA indicated that the ongoing extension of the DURATION-1
study is appropriate to use as the basis for demonstrating comparability between intermediate-scale
clinical trial material made in our manufacturing facility and the commercial-scale drug product
made at Amylins manufacturing facility. The DURATION-1 study is ongoing and results are
expected in early calendar 2009. The collaboration is planning to submit an NDA to the FDA by the
end of the first half of calendar 2009. Additional studies designed to demonstrate the
superiority of exenatide once weekly are ongoing.
ALKS 29
We are developing ALKS 29, an oral compound for the treatment of alcohol dependence. In July
2007, we announced positive preliminary results from a phase 1/2 multi-center, randomized,
double-blind, placebo-controlled, eight-week study that was designed to assess the efficacy and
safety of ALKS 29 in approximately 150 alcohol dependent patients. In the study, ALKS 29 was
generally well tolerated and led to both a statistically significant increase in the percent of
days abstinent and a decrease in drinking compared to placebo when combined with psychosocial
therapy. The study endpoints included the percent of days abstinent, percent of heavy drinking
days and number of drinks per day. Heavy drinking was defined as five or more drinks per day for
men and four or more drinks per day for women.
In December 2008, we initiated a phase 1, open-label crossover study of ALKS 29, which is
designed to assess the pharmacokinetics, safety and tolerability of ALKS 29 compared to an oral
control. We expect to report top-line results from the study in the first half of calendar 2009.
ALKS 27
Using our AIR® pulmonary technology, we are independently developing an inhaled
trospium product for the treatment of chronic obstructive pulmonary disease (COPD). COPD is a
serious, chronic disease characterized by a gradual loss of lung function. Last year, we reported
positive clinical data from a phase 2a study showing that single doses of ALKS 27 demonstrated a
rapid onset of action and produced a significant improvement in lung function compared to placebo.
We are manufacturing clinical trial material for a phase 2 dose ranging study expected to start in
the first quarter of calendar 2009.
ALKS 33
ALKS 33 is a novel opioid modulator, identified from the library of compounds in-licensed from
Rensselaer Polytechnic Institute (RPI). These compounds represent an opportunity for us to
develop important therapeutics for a broad range of diseases and medical conditions, including
addiction, pain and other central nervous system disorders. In July 2008, we announced positive
preclinical results for three proprietary molecules targeting opioid receptors, including ALKS 33.
The study results included efficacy data from an
18
ethanol drinking behavior model in rodents, a well-characterized model for evaluating the
effects of potential therapeutics targeting opioid receptors. Results showed that single, oral
doses of our novel molecules significantly reduced the ethanol drinking behavior in rodents, with
an average reduction from baseline ranging from 35 percent to 50 percent for the proprietary
molecules compared to 10 percent for the naltrexone control arm (P less than 0.05). Details from an
evaluation of the in vivo pharmacology, pharmacokinetics and in vitro metabolism were also
presented. Data showed that the molecules have improved metabolic stability compared to the
naltrexone control arm when cultured with human hepatocytes (liver cells), suggesting that they are
not readily metabolized by the liver, a unique advantage over existing oral therapies for
addiction. Pharmacokinetic results showed that the oral bioavailability of ALKS 33 was
significantly greater than that of the active control.
In December 2008, we initiated a phase 1 randomized, double-blind, placebo-controlled study
for ALKS 33 in approximately 16 healthy volunteers. The study is designed to assess the
pharmacokinetics, safety and tolerability of ALKS 33 following single oral administration at
escalating dose levels. Initiation of this trial is based on recent data from preclinical studies
that showed ALKS 33 demonstrated statistically superior oral efficacy compared to naltrexone. We
expect to report top-line results from the study in the first half of calendar 2009.
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 the
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. Except as
noted in this section, refer to Part II, Item 7 of our Annual Report on Form 10-K for the year
ended March 31, 2008 in the Critical Accounting Policies section for a discussion of our critical
accounting policies and estimates.
Product Revenue Recognition On December 1, 2008, we became responsible for the marketing and
sale of VIVITROL in the U.S. We recognize revenue from the sale of VIVITROL upon delivery, when
title and associated risk of product loss has passed to the customer, and collectibility is
reasonably assured. Due to the expected introduction of a return policy, and as we do not have
history to allow us to estimate returns, we defer the recognition of
revenue on shipments of VIVITROL to our customers until the product has left the distribution
channel. We estimate product shipments out of the distribution channel through data provided by
external sources, including information as to inventory levels provided by our wholesalers,
specialty distributor and specialty pharmacies, as well as prescription information. In order to
match the cost of goods related to products shipped to customers with the associated revenue, we
are deferring the recognition of the cost of goods to the period in which the associated revenue
will be recognized.
Financial Highlights Three and Nine Months Ended December 31, 2008
Net income for the three months ended December 31, 2008 was $112.7 million, or $1.18 per
common share basic and diluted, as compared to net income of $168.9
million, or $1.66 per common share basic and $1.63 per common share diluted, for the three
months ended December 31, 2007. Net income for the nine months ended December 31, 2008 was $144.1
million, or $1.51 per common share basic and $1.49 per common share diluted, as compared to net
income of $185.3 million, or $1.82 per common share basic and $1.78 per common share diluted,
for the nine months ended December 31, 2007.
In connection with the termination of the VIVITROL collaboration with Cephalon, we recognized
$120.7 million of previously deferred and unearned milestone revenue as net collaborative profit in
the three months ended December 31, 2008.
Worldwide sales of RISPERDAL CONSTA by Janssen were $318.8 million and $999.5 million for the
three and nine months ended December 31, 2008, respectively, as compared to $295.1 million and
$867.4 million for the three and nine months ended December 31, 2007, respectively.
19
Results of Operations
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Manufacturing revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
21.3 |
|
|
$ |
12.9 |
|
|
$ |
8.4 |
|
|
$ |
88.0 |
|
|
$ |
66.1 |
|
|
$ |
21.9 |
|
VIVITROL |
|
|
(0.8 |
) |
|
|
1.4 |
|
|
|
(2.2 |
) |
|
|
4.2 |
|
|
|
3.9 |
|
|
|
0.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total manufacturing revenues |
|
|
20.5 |
|
|
|
14.3 |
|
|
|
6.2 |
|
|
|
92.2 |
|
|
|
70.0 |
|
|
|
22.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty revenues |
|
|
8.0 |
|
|
|
7.4 |
|
|
|
0.6 |
|
|
|
25.0 |
|
|
|
21.7 |
|
|
|
3.3 |
|
Research and development revenue under
collaborative arrangements |
|
|
3.8 |
|
|
|
24.0 |
|
|
|
(20.2 |
) |
|
|
40.4 |
|
|
|
68.6 |
|
|
|
(28.2 |
) |
Net collaborative profit |
|
|
123.4 |
|
|
|
5.1 |
|
|
|
118.3 |
|
|
|
125.4 |
|
|
|
18.0 |
|
|
|
107.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
155.7 |
|
|
$ |
50.8 |
|
|
$ |
104.9 |
|
|
$ |
283.0 |
|
|
$ |
178.3 |
|
|
$ |
104.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing Revenues
Under our manufacturing and supply agreement with Janssen, we earn manufacturing revenues when
RISPERDAL CONSTA 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, 2008 and 2007, our RISPERDAL CONSTA manufacturing revenues were based on an average of
7.5% of Janssens unit net sales price of RISPERDAL CONSTA. We anticipate that we will earn
manufacturing revenues at 7.5% of Janssens unit net sales price of RISPERDAL CONSTA for product
shipped during the fiscal year ending March 31, 2009.
The increase in RISPERDAL CONSTA manufacturing revenues for the three and nine months ended
December 31, 2008, as compared to the three and nine months ended December 31, 2007, was primarily
due to a 95% and 29% increase in units shipped to Janssen, respectively, and to unit net sales
price increases. Shipments of RISPERDAL CONSTA were lower in the three and nine months ended
December 31, 2007 as Janssen was managing its product inventory due in part to increased
efficiencies and reliability in our RISPERDAL CONSTA manufacturing process. For the three months
ended December 31, 2008, the increase in the unit net sales price was partially offset by an
overall strengthening of the U.S. dollar in relation to the foreign
currencies of the countries in which the product was sold. For the nine months ended December 31,
2008, the increase in the unit net sales price was due in part to an overall weakening in the
exchange ratio of the U.S. dollar in relation to the foreign currencies of the countries in which
the product was sold. See Part I, Item 3. Quantitative and Qualitative Disclosures about Market
Risk for information on foreign currency exchange rate risk related to RISPERDAL CONSTA revenues.
In connection with the termination of the VIVITROL collaboration with Cephalon, we assumed
title to certain VIVITROL inventory which we had previously sold to Cephalon prior to the
termination. In the three months ended December 31, 2008, we reduced manufacturing revenues by
$(0.8) million to reverse the previous sale of this inventory to Cephalon. VIVITROL manufacturing
revenues for the three months ended December 31, 2007 consisted entirely of product shipped to
Cephalon. For the nine months ended December 31, 2008, VIVITROL manufacturing revenues consisted of
$2.8 million of billings to Cephalon for failed product batches, $0.7 million of net shipments of
VIVITROL to Cephalon, $0.3 million related to manufacturing profit on VIVITROL, which equals a 10%
markup on VIVITROL cost of goods manufactured, all occurring prior to the termination of the
VIVITROL collaboration; and $0.4 million of shipments of VIVITROL to Janssen-Cilag to support
commercialization of VIVITROL in Russia. For the nine months ended December 31, 2007, VIVITROL
manufacturing revenues consisted of $2.2 million of billings to Cephalon for idle capacity costs,
$1.4 million of shipments of VIVITROL to Cephalon and $0.3 million related to manufacturing profit
on VIVITROL, which equals a 10% markup on VIVITROL cost of goods manufactured. Due to the
termination of the VIVITROL collaboration with Cephalon, we expect a decrease in VIVITROL
manufacturing revenues after December 31, 2008 as we will earn manufacturing revenues only on
VIVITROL sold to Janssen-Cilag for sale in Russia.
Prior to the termination of the VIVITROL collaboration with Cephalon, gross sales of VIVITROL
by Cephalon were $3.1 million and $12.6 million for the three and nine months ended December 31,
2008, respectively, and $5.0 million and $13.7 million for the three and nine months ended December
31, 2007, respectively. We began selling VIVITROL in the U.S. on December 1, 2008 upon the
termination of the VIVITROL collaboration with Cephalon and had gross shipments of $1.6 million
made primarily to
20
pharmaceutical wholesalers, specialty pharmacies and distributors. We defer the recognition of
revenue on shipments of VIVITROL to our customers until the product has left the distribution
channel. We estimate product shipments out of the distribution channel through data provided by
external sources, including information on inventory levels provided by our wholesalers,
distributors and specialty pharmacies as well as prescription information.
Royalty Revenues
Royalty revenues for the three and nine months ended December 31, 2008 and 2007 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. Royalty revenues for the three and nine months ended December 31, 2008 were based on
RISPERDAL CONSTA sales of $318.8 million and $999.5 million, respectively. Royalty revenues for the
three and nine months ended December 31, 2007 were based on RISPERDAL CONSTA sales of $295.1
million and $867.4 million, respectively. For the three months ended December 31, 2008, the
increase in sales was partially offset by an overall strengthening of the
U.S. dollar in relation to the foreign currencies of the countries in which the product was sold.
For the nine months ended December 31, 2008, the increase sales was due in part to an overall
weakening of the U.S. dollar in relation to the foreign currencies of the
countries in which the product was sold. See Part I, Item 3. Quantitative and Qualitative
Disclosures about Market Risk for information on foreign currency exchange rate risk related to
RISPERDAL CONSTA revenues.
Research and Development Revenue Under Collaborative Arrangements
The decrease in research and development revenue under collaborative arrangements (R&D
revenue) for the three months ended December 31, 2008, as compared to the three months ended
December 31, 2007, was primarily due to the termination of the AIR Insulin development program in
March 2008 and reductions in revenues earned under the exenatide once weekly development program,
partially offset by increased revenues earned on the four-week RISPERDAL CONSTA development
program. The decrease in R&D revenue for the nine months ended December 31, 2008, as compared to
the nine months ended December 31, 2007, was due to the termination of the AIR Insulin development
program, reductions in revenues earned under the exenatide once weekly development program and the
termination of the AIR parathyroid hormone (PTH) development program in the quarter ended
September 30, 2007, partially offset by increased revenues earned on the four-week RISPERDAL CONSTA
development program.
In
June 2008, we entered into an agreement with Eli Lilly and
Company (Lilly) in connection with the termination of
the development and license agreements and supply agreement for the development of AIR Insulin (the
AIR Insulin Termination Agreement). Under the AIR Insulin Termination Agreement, we received
$40.0 million in cash as payment for all services we had performed through the date of the AIR
Insulin Termination Agreement. We previously recognized $14.5 million of this payment as R&D
revenue in the year ended March 31, 2008 and recognized $25.5 million of this payment as R&D
revenue in the three months ended June 30, 2008. Revenues from the AIR Insulin development program
totaled $10.9 million and $36.8 million for the three and nine months ended December 31, 2007,
respectively. We do not expect to record any material amounts of revenue from the AIR Insulin
development program in the future.
The decrease in the revenues earned under the exenatide once weekly development program was
due to reduced activity as the program nears the anticipated date of submission of the NDA to the
FDA. Revenues from the exenatide once weekly development program totaled $1.5 million and $9.3
million for the three and nine months ended December 31, 2008, as compared to $12.5 million and
$24.9 million for the three and nine months ended December 31, 2007. We also saw a decline in
revenues during the nine months ended December 31, 2008, as compared to the nine months ended
December 31, 2007, due to the termination of the AIR PTH development program during the three months
ended September 30, 2007. This decline was partially offset by revenues earned on the
four-week RISPERDAL CONSTA development program.
21
Net Collaborative Profit
Net collaborative profit for the three and nine months ended December 31 consists of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Milestone revenue cost recovery |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5.3 |
|
Milestone revenue license |
|
|
0.8 |
|
|
|
1.3 |
|
|
|
3.5 |
|
|
|
3.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total milestone revenue cost recovery and license |
|
|
0.8 |
|
|
|
1.3 |
|
|
|
3.5 |
|
|
|
9.2 |
|
Net payments from Cephalon |
|
|
0.7 |
|
|
|
3.8 |
|
|
|
|
|
|
|
8.8 |
|
VIVITROL losses funded by Cephalon, post termination |
|
|
1.2 |
|
|
|
|
|
|
|
1.2 |
|
|
|
|
|
Recognition of deferred and unearned milestone revenue
due to termination of VIVITROL collaboration |
|
|
120.7 |
|
|
|
|
|
|
|
120.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net collaborative profit |
|
$ |
123.4 |
|
|
$ |
5.1 |
|
|
$ |
125.4 |
|
|
$ |
18.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prior to the termination of the VIVITROL collaboration, Cephalon had paid us an aggregate of
$274.6 million in non-refundable milestone payments and we were responsible to fund the first
$124.6 million of cumulative net losses incurred on VIVITROL (the cumulative net loss cap).
VIVITROL reached the cumulative net loss cap in April 2007, at which time Cephalon became
responsible to fund all net losses incurred on VIVITROL through December 31, 2007. Beginning
January 1, 2008, all net losses incurred on VIVITROL within the collaboration were divided between
us and Cephalon in approximately equal shares. For the three and nine months ended December 31,
2008, we recognized no milestone revenue cost recovery, as VIVITROL had reached the cumulative
loss cap prior to these reporting periods. Milestone revenue license, related to the license
provided to Cephalon to commercialize VIVITROL and was being recognized on a straight-line basis
over 10 years, at approximately $5.2 million per year. Net payments from Cephalon were received
based upon the sharing of VIVITROL costs and losses incurred during the reporting periods.
Upon the termination of the VIVITROL collaboration with Cephalon, we received $11.0 million
from Cephalon to fund their share of VIVITROL product losses during the one-year period following
the Termination Date. We recorded the $11.0 million as deferred revenue and are recognizing it as
revenue though the application of a proportional performance model
based on VIVITROL net product losses. In the three months ended
December 31, 2008, we recognized $1.2 million of revenue under proportional performance. In
addition, we recognized $120.7 million of net collaborative profit, consisting of $113.9 million of
unearned milestone revenue that existed at the Termination Date and $6.8 million of deferred
revenue. At the Termination Date, we had $22.8 million of deferred revenue related to the original
sale of the two partially completed VIVITROL manufacturing lines to Cephalon. We paid Cephalon
$16.0 million to acquire the title to these manufacturing lines and accounted for the payment as
a reduction to deferred revenue. The remaining $6.8 million of deferred revenue and the $113.9
million of unearned milestone revenue were recognized in the three months ended December 31, 2008,
as we had no remaining performance obligations to Cephalon and the amounts were nonrefundable. We
do not expect to recognize any further net collaborative profit after the $11.0 million payment has
been fully recognized as revenue, which we expect to occur in fiscal year 2010.
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Cost of goods sold: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
5.0 |
|
|
$ |
5.9 |
|
|
$ |
0.9 |
|
|
$ |
24.0 |
|
|
$ |
23.0 |
|
|
$ |
(1.0 |
) |
VIVITROL |
|
|
0.5 |
|
|
|
1.6 |
|
|
|
1.1 |
|
|
|
7.9 |
|
|
|
3.9 |
|
|
|
(4.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of goods sold |
|
|
5.5 |
|
|
|
7.5 |
|
|
|
2.0 |
|
|
|
31.9 |
|
|
|
26.9 |
|
|
|
(5.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
22.7 |
|
|
|
30.4 |
|
|
|
7.7 |
|
|
|
64.6 |
|
|
|
91.3 |
|
|
|
26.7 |
|
Selling, general and administrative |
|
|
14.6 |
|
|
|
15.2 |
|
|
|
0.6 |
|
|
|
38.2 |
|
|
|
45.1 |
|
|
|
6.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
$ |
42.8 |
|
|
$ |
53.1 |
|
|
$ |
10.3 |
|
|
$ |
134.7 |
|
|
$ |
163.3 |
|
|
$ |
28.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Goods Sold
22
RISPERDAL CONSTA cost of goods sold for the three months ended December 31, 2008 decreased, as
compared to the three months ended December 31, 2007, due to a decrease in the unit cost of
RISPERDAL CONSTA shipped, partially offset by an increase in the number of units shipped. The
increase in RISPERDAL CONSTA cost of goods sold for the nine months ended December 31, 2008, as
compared to the nine months ended December 31, 2007, was due to an increase in units of RISPERDAL
CONSTA shipped to Janssen, partially offset by a decrease in the unit cost of RISPERDAL CONSTA
shipped.
VIVITROL cost of goods sold for the three months ended December 31, 2008 consisted of $1.0
million of expense related to the restart of the VIVITROL manufacturing line following a planned
manufacturing shutdown, $0.2 million of cost for failed product batches, offset by a reduction in
cost of goods sold due to the reversal of prior sales of VIVITROL to
Cephalon of $0.7 million in connection with the termination of
the VIVITROL collaboration with Cephalon. Cost
of goods sold for VIVITROL for the three months ended December 31, 2007 consisted of $1.1 million
for shipments of VIVITROL to Cephalon and $0.5 million for idle capacity costs, which consisted of
current period manufacturing costs related to underutilized VIVITROL manufacturing capacity.
VIVITROL cost of goods sold for the nine months ended December 31, 2008 consisted of $3.6
million of expense related to the restart of the VIVITROL manufacturing line following a planned
shutdown, $3.4 million of cost for failed batches, $1.3 million for shipments of VIVITROL to
Cephalon, and $0.3 million of shipments to Janssen-Cilag to support the commercialization of
VIVITROL in Russia. These costs were partially offset by the reversal of prior sales of VIVITROL to
Cephalon of $0.7 million. Cost of goods sold for VIVITROL for the nine months ended December 31,
2007 consisted of $1.1 million for shipments of VIVITROL to Cephalon and $2.8 million for idle
capacity costs, which consisted of current period manufacturing costs related to underutilized
VIVITROL manufacturing capacity.
Research and Development
The decrease in research and development expenses for the three months ended December 31,
2008, as compared to the three months ended December 31, 2007, was primarily due to the termination
of the AIR Insulin development program in March 2008, and reductions in costs on the exenatide once
weekly development program as the program nears the anticipated date of submission of the NDA to
the FDA. These reductions were partially offset by increased costs on the ALKS 29 and ALKS 33 programs, which
began phase 1 clinical trials in the three months ended December 31, 2008, costs related to the
four-week RISPERDAL CONSTA development program, which began phase 1 clinical trials in January 2009,
and the VIVITROL opioid dependence development program, in which a multi-center registration study
was initiated in June 2008.
The decrease in research and development expenses for the nine months ended December 31, 2008,
as compared to the nine months ended December 31, 2007, was primarily due to the termination of the
AIR Insulin development program in March 2008, the termination of the AIR PTH development program
in the quarter ended September 30, 2007 and reductions in costs on the exenatide once weekly
development program. These reductions were partially offset by increased costs on the ALKS 29, ALKS
33, four-week RISPERDAL CONSTA and the VIVITROL opioid dependence development programs.
A significant portion of our research and development expenses (including laboratory supplies,
travel, dues and subscriptions, recruiting costs, temporary help costs, consulting costs and
allocable costs such as occupancy and depreciation) are not tracked by project as they benefit
multiple projects or our technologies in general. Expenses incurred to purchase specific services
from third parties to support our collaborative research and development activities are tracked by
project and are reimbursed to us by our partners. We generally bill our partners under
collaborative arrangements using a negotiated full-time equivalent (FTE) or hourly rate. This
rate has been established by us based on our annual budget of employee compensation, employee
benefits and the billable non-project-specific costs mentioned above and is generally increased
annually based on increases in the consumer price index. Each collaborative partner is billed using
a negotiated FTE or hourly rate for the hours worked by our employees on a particular project, plus
direct external costs, if any. We account for our research and development expenses on a
departmental and functional basis in accordance with our budget and management practices.
Selling, General and Administrative
The decrease in selling, general and administrative expenses for the three months ended
December 31, 2008, as compared to the three months ended December 31, 2007, was primarily due to a
decrease in share-based compensation expense, consulting expense and IT-related expenses, partially
offset by increased sales and marketing expenses in
December 2008 related to VIVITROL. The decrease
in selling, general and administrative expenses for the nine months ended December 31, 2008, as
compared to the nine months ended December 31, 2007, was primarily due to a decrease in personnel
related costs, including share-based compensation expense, professional fees and taxes, partially
offset by the increased sales and marketing expenses related to VIVITROL.
23
Other (Expense) Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Interest income |
|
$ |
2.6 |
|
|
$ |
4.3 |
|
|
$ |
(1.7 |
) |
|
$ |
8.9 |
|
|
$ |
12.9 |
|
|
$ |
(4.0 |
) |
Interest expense |
|
|
(2.4 |
) |
|
|
(4.1 |
) |
|
|
1.7 |
|
|
|
(10.9 |
) |
|
|
(12.2 |
) |
|
|
1.3 |
|
Other (expense) income |
|
|
(0.7 |
) |
|
|
(0.4 |
) |
|
|
(0.3 |
) |
|
|
(1.5 |
) |
|
|
0.8 |
|
|
|
(2.3 |
) |
Gain on sale of investment in Reliant
Pharmaceuticals, Inc. |
|
|
|
|
|
|
174.6 |
|
|
|
(174.6 |
) |
|
|
|
|
|
|
174.6 |
|
|
|
(174.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (expense) income |
|
$ |
(0.5 |
) |
|
$ |
174.4 |
|
|
$ |
(174.9 |
) |
|
$ |
(3.5 |
) |
|
$ |
176.1 |
|
|
$ |
(179.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
The decrease in interest income for the three and nine months ended December 31, 2008, as
compared to the three and nine months ended December 31, 2007, was due to lower interest rates
earned during the comparable periods, partially offset by a higher average balance of cash and
investments. We expect our interest earnings to decrease as compared to prior periods due to
a general reduction in interest rates.
Interest expense
The decrease in interest expense for the three months ended December 31, 2008, as compared to
December 31, 2007, was a result of the purchase of $75.0 million in principal amount of our
non-recourse RISPERDAL CONSTA secured 7% notes (the 7% Notes) in three privately negotiated
transactions in June and July 2008. The decrease in interest expense for the nine months ended
December 31, 2008, as compared to December 31, 2007, was due to reduced interest expense due to the
repurchase of the 7% Notes, partially offset by an aggregate of $2.0 million in debt extinguishment
charges related to the 7% Notes repurchases, which were recorded as interest expense in June and
July 2008. We expect our interest expense to decrease as compared to prior periods due to the
decrease in our borrowings.
Other (expense) income
The increase in other expense for the three months ended December 31, 2008, as compared to the
three months ended December 31, 2007, was primarily due to increased charges for
other-than-temporary impairments on our investments in the common stock of certain publicly held
companies. Other expense during the nine months ended December 31, 2008 consisted primarily of
charges for other-than-temporary impairments on our investments in the common stock of certain
publicly held companies, compared to other income during the nine months ended December 31, 2007,
which consisted primarily of income recognized on the changes in the fair value of our investments
in warrants of certain publicly held companies, partially offset by other-than-temporary impairment
charges on our investments in the common stock of certain publicly held companies.
Gain on sale of investment in Reliant Pharmaceuticals, Inc.
The gain on sale of investment in Reliant Pharmaceuticals, Inc. (Reliant), for the three and
nine months ended December 31, 2007 is due to the purchase of Reliant by GlaxoSmithKline (GSK) in
November 2007. Under the terms of the acquisition, we received $166.9 million upon the closing of
the transaction in December 2007 in exchange for our investment in Series C convertible, redeemable
preferred stock of Reliant. In March 2009, we are entitled to receive up to an additional $7.7
million of funds held in escrow subject to the terms of an escrow agreement between GSK and
Reliant.
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
December 31, |
|
|
December 31, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Income tax (benefit) provision |
|
$ |
(0.3 |
) |
|
$ |
3.2 |
|
|
$ |
3.5 |
|
|
$ |
0.6 |
|
|
$ |
5.8 |
|
|
$ |
5.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
24
We
earned income before income taxes of $112.4 million and $144.7 million during the three and
nine months ended December 31, 2008, respectively, and we recorded an income tax benefit of $0.3
million and an income tax provision of $0.6 million for the three and nine months ended December
31, 2008, respectively. This variation is due to the termination of the VIVITROL collaboration with
Cephalon. We previously recognized, for tax purposes, the milestone payments received from Cephalon
under the VIVITROL collaboration. The income tax benefit and provision recorded for the three and
nine months ended December 31, 2008, respectively, and the income tax provision of $3.2 million and
$5.8 million for the three and nine months ended December 31, 2007, respectively, related to the
U.S. alternative minimum tax (AMT). Included in the $0.6 million provision for the nine months
ended December 31, 2008 is a $0.1 million estimated benefit as a result of the recently enacted
Housing and Economic Recovery Act of 2008. This legislation allows for certain taxpayers to forego
bonus depreciation in lieu of a refundable cash credit based on certain qualified asset purchases.
The utilization of tax loss carryforwards is limited in the calculation of AMT and, as a
result, a federal tax benefit was recorded in the three months ended
December 31, 2008, and a
federal tax charge was recorded in the nine months ended
December 31, 2008 and in the three and
nine months ended December 31, 2007. The AMT liability is available as a credit against future tax
obligations upon the full utilization or expiration of the Companys net operating loss
carryforward.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
March 31, |
|
(In millions) |
|
2008 |
|
|
2008 |
|
Cash and cash equivalents |
|
$ |
63.3 |
|
|
$ |
101.2 |
|
Investments short-term |
|
|
281.4 |
|
|
|
240.1 |
|
Investments long-term |
|
|
78.9 |
|
|
|
119.1 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents and investments |
|
$ |
423.6 |
|
|
$ |
460.4 |
|
|
|
|
|
|
|
|
Working capital |
|
$ |
341.7 |
|
|
$ |
371.1 |
|
|
|
|
|
|
|
|
Outstanding borrowings current and long-term |
|
$ |
92.4 |
|
|
$ |
160.4 |
|
|
|
|
|
|
|
|
Operating Activities
Cash provided by operating activities was $43.2 million and $28.0 million for the nine months
ended December 31, 2008 and 2007, respectively. The increase in cash flows from operating
activities in the nine months ended December 31, 2008, as compared to the nine months ended
December 31, 2007, was primarily due to the $40.0 million we received from Lilly related to the AIR
Insulin Termination Agreement, of which $25.5 million was recognized as revenue in the first
quarter of fiscal 2009, and a net reduction in working capital accounts.
Investing Activities
Cash provided by investing activities was $0.9 million and $231.3 million for the nine months
ended December 31, 2008 and 2007, respectively. The decrease in cash provided by investing
activities in the nine months ended December 31, 2008, as compared to the nine months ended
December 31, 2007, was due to the $166.9 million we received from the sale of our investment in
Reliant and $82.1 million in net sales of investments in the nine months ended December 31, 2007,
partially offset by reduced purchases of property, plant and equipment.
Financing Activities
Cash used in financing activities was $82.1 million and $18.9 million in the nine months ended
December 31, 2008 and 2007, respectively. The increase in cash used in financing activities in the
nine months ended December 31, 2008, as compared to the nine months ended December 31, 2007, was
due to the purchase of $75.0 million principal amount of our
non-recourse RISPERDAL CONSTA 7% notes (the 7% Notes)
for $71.8 million during the nine months ended December 31, 2008, partially offset by a $9.7
million decrease in the amount of treasury stock purchased under our publicly announced share
repurchase programs.
We invest in short-term and long-term investments consisting of U.S. government and agency
debt securities, investment grade corporate debt securities, including asset backed debt
securities, and student loan backed auction rate securities issued by major financial institutions
in accordance with our documented corporate policies. Our investment objectives are, first, to
assure liquidity
25
and conservation of capital and, second, to obtain investment income. At December 31, 2008, we
had gross unrealized gains of $4.0 million and gross unrealized losses of $5.8 million in our
investment portfolio. We performed an analysis of our investments with unrealized losses at
December 31, 2008 for impairment and determined that they are temporarily impaired and consist
primarily of investments in corporate debt securities, including asset backed debt securities and
student loan backed auction rate securities. We determined that we had an other-than-temporary
impairment of $0.6 million attributed to investments in the common stock of certain collaborative
partners. Temporary impairments are unrealized and are recorded in accumulated other comprehensive
income, a component of shareholders equity. Other-than-temporary impairments are realized and
recorded in our condensed consolidated statements of income.
At December 31, 2008, we have classified $74.2 million of our available-for-sale investments
in securities with temporary losses of $5.8 million as Investments Long-Term in the accompanying
condensed consolidated balance sheet, as we believe the recovery of the losses will extend beyond
one year and we have the intent and ability to hold the investments to recovery, which may be
maturity.
On April 1, 2008, we implemented SFAS No. 157, Fair Value Measurements (SFAS No. 157) for
our financial assets and liabilities that are re-measured and reported at fair value at each
reporting period. SFAS No. 157 provides a framework for measuring fair value and requires expanded
disclosures regarding fair value measurements. SFAS No. 157 defines fair value as the price that
would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly
transaction between market participants at the measurement date. In determining fair value, SFAS
No. 157 permits the use of various valuation approaches, including market, income and cost
approaches. SFAS No. 157 establishes a hierarchy for inputs used in measuring fair value that
maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available.
The fair value hierarchy is broken down into three levels based on the reliability of inputs.
We have categorized our cash, cash equivalents and investments within the hierarchy as follows:
Level 1 - These valuations are based on a market approach using quoted prices in active
markets for identical assets. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 1 inputs include investments in money market funds, U.S.
government debt securities, U.S. agency debt securities, municipal debt securities, bank deposits
and exchange-traded equity securities of certain publicly held companies;
Level 2 - These valuations are based on a market approach using quoted prices obtained from
brokers or dealers for similar securities or for securities for which we have limited visibility
into their trading volumes. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 2 inputs consist of investments in corporate debt securities;
and
Level 3 - These valuations are based on an income approach using certain inputs that are
unobservable and are significant to the overall fair value measurement. Valuations of these
products require a significant degree of judgment. Assets utilizing Level 3 inputs consist of
investments in auction rate securities and asset backed debt securities that are not currently
trading. In addition, we hold warrants in certain publicly held companies that are classified
using Level 3 inputs. The carrying balance of these warrants was immaterial at December 31, 2008
and March 31, 2008.
Our investments in auction rate securities have a cost of $10.0 million and invest in taxable
student loan revenue bonds issued by state higher education authorities which service student loans
under the Federal Family Education Loan Program. The bonds were triple A rated at the date of
purchase and are collateralized by student loans purchased by the authorities which are guaranteed
by state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity for these
securities is typically provided by an auction process that resets the applicable interest rate at
pre-determined intervals. Each of these securities had been subject to auction processes for which
there had been insufficient bidders on the scheduled auction dates and the auctions subsequently
failed. We are not able to liquidate our investments in auction rate securities until future
auctions are successful, a buyer is found outside of the auction process or the notes are redeemed
by the issuer. The securities continue to pay interest at predetermined interest rates during the
periods in which the auctions have failed.
Typically, auction rate securities trade at their par value due to the short interest rate
reset period and the availability of buyers or sellers of the securities at recurring auctions.
However, since the security auctions have failed and fair value cannot be derived from quoted
prices, we used a discounted cash flow model to determine the estimated fair value of the
securities at December 31, 2008. Our valuation analyses consider, among other items, assumptions
that market participants would use in their estimates of fair value, such as the collateral
underlying the security, the creditworthiness of the issuer and any associated guarantees, the
timing of expected future cash flows, and the expectation of the next time the security will have a
successful auction or when callability features may be exercised by the issuer. These securities
were also compared, where possible, to other observable market data with similar characteristics to
the securities held by us. Based upon this methodology, we have recorded an unrealized loss related
to our
26
investments in auction rate securities of approximately $1.1 million to accumulated other
comprehensive income at December 31, 2008. We believe there are several significant assumptions
that are utilized in our valuation analysis, the two most critical of which are the discount rate,
which includes a provision for default and liquidity risk, and the average expected term.
At December 31, 2008, we determined that the securities had been temporarily impaired due to
the length of time each security was in an unrealized loss position, the extent to which fair value
was less than cost, financial condition and near term prospects of the issuers and our intent and
ability to hold each security for a period of time sufficient to allow for any anticipated recovery
in fair value. We do not expect the estimated fair value of these securities to decrease
significantly in the future unless credit market conditions continue to deteriorate significantly.
Our investments in asset backed debt securities have a cost of $7.5 million and consist of
investment grade medium term floating rate notes (MTN) of Aleutian Investments, LLC (Aleutian)
and Meridian Funding Company, LLC (Meridian), which are qualified special purpose entities
(QSPE) of Ambac Financial Group, Inc. (Ambac) and MBIA, Inc. (MBIA), respectively. Ambac and
MBIA are guarantors of financial obligations and are referred to as monoline financial guarantee
insurance companies. The QSPEs, which purchase pools of assets or securities and fund the purchase
through the issuance of MTNs, have been established to provide a vehicle to access the capital
markets for asset backed debt securities and corporate borrowers. The MTNs include a sinking fund
redemption feature which match-fund the terms of redemptions to the maturity dates of the
underlying pools of assets or securities in order to mitigate potential liquidity risk to the
QSPEs. At December 31, 2008, a substantial portion of our initial investment in the Meridian MTNs
had been redeemed by MBIA through scheduled sinking fund redemptions at par value, and the first
sinking fund redemption on the Aleutian MTN is scheduled for June 2009.
The liquidity and fair value of these securities has been negatively impacted by the
uncertainty in the credit markets and the exposure of these securities to the financial condition
of monoline financial guarantee insurance companies, including Ambac and MBIA. In June 2008, Ambac
had its triple A rating reduced to Aa3 by Moodys and in November, Moodys further downgraded
Ambacs rating to Baa1 with a developing outlook. Standard and Poors (S&P) reduced Ambacs
rating to double A in June 2008 and in August 2008, affirmed its double A rating with a negative
outlook. In June 2008, MBIA was downgraded from triple A to A2 by Moodys and in September Moodys
placed MBIA on review for possible downgrade. S&P reduced MBIAs rating to double A in June 2008
and in August 2008, affirmed its double A rating with a negative outlook. All downgrades were due
to Ambacs and MBIAs inability to maintain triple A capital levels.
We may not be able to liquidate our investment in these securities before the scheduled
redemptions or until trading in the securities resumes in the credit markets, which may not occur.
Because the MTNs are not actively trading in the credit markets and fair value cannot be derived
from quoted prices, we used a discounted cash flow model to determine the estimated fair value of
the securities at December 31, 2008. Our valuation analyses consider, among other items,
assumptions that market participants would use in their estimates of fair value such as the
collateral underlying the security, the creditworthiness of the issuer and the associated
guarantees by Ambac and MBIA, the timing of expected future cash flows, including whether the
callability features of these investments may be exercised by the issuer. Based upon this
methodology, we have an unrealized loss related to these asset backed debt securities of
approximately $0.9 million in accumulated other comprehensive income at December 31, 2008. We
believe there are several significant assumptions that are utilized in our valuation analysis, the
two most critical of which are the discount rate, which includes a provision for default and
liquidity risk, and the average expected term.
At December 31, 2008, we determined that the securities had been temporarily impaired due to
the length of time each security was in an unrealized loss position, the extent to which fair value
was less than cost, the financial condition and near term prospects of the issuers, current
redemptions made by one of the issuers and our intent and ability to hold each security for a
period of time sufficient to allow for any anticipated recovery in fair value or until scheduled
redemption. We do not expect the estimated fair value of these securities to decrease significantly
in the future unless credit market conditions continue to deteriorate significantly or the credit
ratings of the issuers are further downgraded.
We have funded our operations primarily with funds generated by our business operations and
through public offerings and private placements of debt and equity securities, bank loans, term
loans, equipment financing arrangements and payments received under research and development
agreements and other agreements with collaborators. We expect to incur significant additional
research and development and other costs as we expand the development of our proprietary product
candidates, including costs related to preclinical studies and clinical trials. Our costs,
including research and development costs for our product candidates, manufacturing, and sales,
marketing and promotional expenses for any current or future products marketed by us or our
collaborators, if any, may exceed revenues in the future, which may result in losses from
operations. We believe that our current cash and cash equivalents and
27
short-term investments, combined with anticipated interest income and anticipated revenues
will generate sufficient cash flows to meet our anticipated liquidity and capital requirements for
the foreseeable future.
We do not believe that inflation and changing prices have had a material impact on our results
of operations.
Borrowings
At December 31, 2008, our borrowings consisted of our 7% Notes, which had a carrying value of
$92.4 million. We are currently making interest payments on the 7% Notes, with principal payments
scheduled to begin in April 2009. In June and July 2008, in three separate privately negotiated
transactions, we purchased an aggregate total of $75.0 million principal amount of the 7% Notes for
$71.8 million. We recorded a loss on the extinguishment of the notes of $2.0 million during the
nine months ended December 31, 2008. As a result of the purchases, $95.0 principal amount of the 7%
Notes remains outstanding, and we will save approximately $9.5 million in interest payments over
the remaining life of the 7% notes.
Capital Requirements
We may continue to pursue opportunities to obtain additional financing in the future. Such
financing may be sought through various sources, including debt and equity offerings, corporate
collaborations, bank borrowings, arrangements relating to assets or other financing methods or
structures. The source, timing and availability of any financings will depend on market conditions,
interest rates and other factors. Our future capital requirements will also depend on many factors,
including continued scientific progress in our research and development programs (including our
proprietary product candidates), the size of these programs, progress with preclinical testing and
clinical trials, the time and costs involved in obtaining regulatory approvals, the costs involved
in filing, prosecuting and enforcing patent claims, the presence of competing technologies and the
occurrence of market developments, the establishment of additional collaborative arrangements, the
cost of manufacturing facilities and of commercialization activities and arrangements and the cost
of product in-licensing and any possible acquisitions and, for any current or future proprietary
products, the sales, marketing and promotion expenses associated with marketing such products. We
may from time to time seek to retire or purchase our outstanding debt through cash purchases and/or
exchanges for equity securities, in open market purchases, privately negotiated transactions or
otherwise. Such repurchases or exchanges, if any, will depend on prevailing market conditions, our
liquidity requirements, contractual restrictions and other factors. The amounts involved may be
material.
We may need to raise substantial additional funds for longer-term product development,
including development of our proprietary product candidates, regulatory approvals and manufacturing
and sales and marketing activities that we might undertake in the future. There can be no assurance
that additional funds will be available on favorable terms, if at all. If adequate funds are not
available, we may be required to curtail significantly one or more of our research and development
programs and/or obtain funds through arrangements with collaborative partners or others that may
require us to relinquish rights to certain of our technologies, product candidates or future
products.
Capital expenditures are expected in the range from $2.5 million to $3.5 million for the year
ending March 31, 2009.
Contractual Obligations
With the exception of the repurchases of our 7% Notes, discussed above under Borrowings, and
in Note 11 to the accompanying condensed consolidated financial statements, the contractual cash
obligations disclosed in our Annual Report on Form 10-K for the year ended March 31, 2008 have not
changed materially since the date of that report.
Off-Balance Sheet Arrangements
As of December 31, 2008, 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.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We hold financial instruments in our investment portfolio that are sensitive to market risks.
Our investment portfolio, excluding warrants and equity securities we hold in connection with our
collaborations and licensing activities, is used to preserve capital until it is required to fund
operations. Our held-to-maturity investments are restricted and are held as collateral under
certain letters of credit
28
related to our lease agreements. Our short-term and long-term investments consist of U.S.
government debt securities, U.S. agency debt securities, municipal debt securities, investment
grade corporate debt securities, including asset backed debt securities, and auction rate
securities. These debt securities are: (i) classified as available-for-sale; (ii) recorded at fair
value; and (iii) subject to interest rate risk, and could decline in value if interest rates
increase. Fixed rate interest securities may have their market value adversely impacted by a rise
in interest rates, while floating rate securities may produce less income than expected if interest
rates fall. Due in part to these factors, our future investment income may fall short of
expectation due to a fall in interest rates or we may suffer losses in principal if we are forced
to sell securities that decline in the market value due to changes in interest rates. However,
because we classify our investments in debt securities as available-for-sale, no gains or losses
are recognized due to changes in interest rates unless such securities are sold prior to maturity
or declines in fair value are determined to be other-than-temporary. Should interest rates
fluctuate by 10%, our interest income would change by approximately $1.2 million over an annual
period. Due to the conservative nature of our short-term and long-term investments and our
investment policy, we do not believe that we have a material exposure to interest rate risk.
Although our investments are subject to credit risk, our investment policies specify credit quality
standards for our investments and limit the amount of credit exposure from any single issue, issuer
or type of investment.
Our investments that are subject to the greatest credit risk at this time are our investments
in asset backed debt securities and auction rate securities. Holding all other factors constant, if
we were to increase the discount rate utilized in our valuation analysis of the asset backed debt
securities and auction rate securities by 50 basis points (one-half of a percentage point), this
change would have the effect of reducing the fair value of these investments by approximately $0.4
million and $0.1 million at December 31, 2008, respectively. Similarly, holding all other factors
constant, if we were to assume that the expected term of the asset backed debt securities was the
full contractual maturity, which could be through calendar year 2012, this change would have the
effect of reducing the fair value of these securities by approximately $0.7 million at December 31,
2008. As it relates to auction rate securities, holding all other factors constant, if we were to
increase the average expected term utilized in our fair value analysis by one year, this change
would have the effect of reducing the fair value of these securities by approximately $0.3 million
at December 31, 2008.
We also hold warrants to purchase the equity securities of certain publicly held companies
that are considered derivative instruments and are recorded at fair value. These securities are
sensitive to changes in interest rates. Interest rate changes would result in a change in the fair
value of warrants due to the difference between the market interest rate and the rate at the date
of purchase. A 10% increase or decrease in market interest rates would not have a material impact
on our consolidated financial statements.
At December 31, 2008, the fair value of our 7% Notes approximated the carrying value. The
interest rate on these notes are fixed and therefore not subject to interest rate risk.
Foreign Currency Exchange Rate Risk
The manufacturing and royalty revenues we receive on RISPERDAL CONSTA are a percentage of the
net sales made by our collaborative partner, Janssen. A majority of these sales are made in foreign
countries and are denominated in foreign currencies. The manufacturing and royalty payments on
these foreign sales is calculated initially in the foreign currency in which the sale is made and
is then converted into U.S. dollars to determine the amount that Janssen pays us for manufacturing
and royalty revenues. Fluctuations in the exchange ratio of the U.S. dollar and these foreign
currencies will have the effect of increasing or decreasing our manufacturing and royalty revenues
even if there is a constant amount of sales in foreign currencies. For example, if the U.S. dollar
weakens against a foreign currency, then our manufacturing and royalty revenues will increase given
a constant amount of sales in such foreign currency.
The impact on our manufacturing and royalty revenues from foreign currency exchange rate risk
is based on a number of factors, including the exchange rate (and the change in the exchange rate
from the prior period) between a foreign currency and the U.S. dollar, and the amount of RISPERDAL
CONSTA sales by Janssen that are denominated in foreign currencies. For the nine months ended
December 31, 2008, an average 10% strengthening of the U.S. dollar relative to the currencies in
which RISPERDAL CONSTA is sold, would have resulted in our manufacturing and royalty revenues being
reduced by approximately $7.5 million and $1.6 million, respectively. We do not currently hedge our
foreign currency exchange rate risk.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation, under the supervision and the participation of our
management, including our principal executive officer and principal financial officer, of the
effectiveness of the design and operation of our disclosure controls and
29
procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as
amended, or the Securities Exchange Act) at December 31, 2008. Based upon that evaluation, our
principal executive officer and principal financial officer concluded that, at December 31, 2008,
our disclosure controls and procedures are effective in providing reasonable assurance that (a) the
information required to be disclosed by us in the reports that we file or submit under the
Securities Exchange Act is recorded, processed, summarized and reported within the time periods
specified in the Securities and Exchange Commissions (SEC) rules and forms, and (b) such
information is accumulated and communicated to our management, including our principal executive
officer and principal financial officer, as appropriate to allow timely decisions regarding
required disclosure. In designing and evaluating our disclosure controls and procedures, our
management recognized that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives, and our
management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
(b) Change in Internal Control over Financial Reporting
During the period covered by this report, there have been no changes in our internal control
over financial reporting that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
30
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Please see the Legal Proceedings section of our Annual Report on Form 10-K for the year ended
March 31, 2008 for more information on litigation to which we are a party.
Item 1A. Risk Factors
The
following risk factors are added to those included in our Annual Report on Form 10-K
for the year ended March 31, 2008 as well as those included in
our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2008 which are hereby incorporated by reference.
VIVITROL may not be successfully marketed and sold by Alkermes and may not generate significant
revenues
In
November 2008, we ended our collaboration with Cephalon
related to VIVITROL. As part of the termination, we assumed all risks and responsibilities
associated with the marketing and sale of VIVITROL. The revenues from
the sale of VIVITROL have not been and may not become significant and will
depend on numerous factors including but not limited to those specified below.
We
have little experience with the commercialization of pharmaceutical
products, including the marketing and sale of prescription drugs. We must
build an infrastructure to support the sales and marketing of
VIVITROL, including integrating members of the Cephalon sales force
with our existing field force to build our own sales
force, building a distribution and expanded commercial infrastructure and providing various support
services for the sales force. Our ability to realize significant revenues from the marketing and
sales activities associated with VIVITROL depends on our ability to retain qualified sales personnel
for the sale and marketing of VIVITROL. We must also be able to attract new qualified sales
personnel as needed to support potential sales growth and competition for qualified sales personnel
is intense. Any failure to attract and retain qualified sales personnel now and in the future,
could impair our ability to maintain sales levels and/or support
potential future sales growth.
We are responsible for the entire supply chain and distribution network for VIVITROL. We have
limited experience in managing a complex, cGMP supply chain and pharmaceutical product distribution
network. The manufacture of products and product components,
packaging, storage and distribution
of our products require successful coordination among ourselves and multiple third party providers.
Issues with third parties who are part of our supply chain, including but
not limited to suppliers, third party logistics
31
providers, distributors, wholesalers, and specialty pharmacies may have a material adverse
effect on our business, results of operations and financial condition. Our inability to coordinate
these efforts, the lack of capacity available from third parties or any other problems with
third party operators could cause a delay in shipment of saleable
products; a recall of products previously shipped or an impairment of our ability to supply products at all. These setbacks
could increase our costs, cause us to lose revenue or market share and damage our reputation.
Sales of our products are dependent, in part, on the availability of reimbursement from
third-party payors such as federal and state government agencies under programs such as Medicare
and Medicaid, and private insurance plans.
There have been, there are, and we expect there will continue to be, state and federal
legislative and/or administrative proposals that could limit the amount that state or federal
governments will pay to reimburse the cost of pharmaceutical products. Legislative or
administrative acts that reduce reimbursement for our products could
adversely affect our business. Third party payors continually attempt to contain
or reduce the cost of health care by challenging the prices charged
for medical products and services. We may not be able to sell
VIVITROL profitably if reimbursement is unavailable or coverage is
limited in scope or amount.
In addition, private insurers, such as managed care organizations, may adopt their own coverage
restrictions or demand price concessions in response to legislation or administrative action.
Reduction in reimbursement for our products could have a material adverse effect on our results of
operations. Also, the increasing emphasis on managed care in the
U.S. may put increased
pressure on the price and usage of our products, which may adversely affect product sales. We
cannot predict the availability or amount of reimbursement for VIVITROL and current reimbursement
policies may change at any time.
If reimbursement for VIVITROL changes adversely, health care providers may limit how much or
under what circumstances they will prescribe or administer VIVITROL, which could reduce use of
VIVITROL or cause us to reduce the price of our product.
Additionally,
we have assumed all of the risks and responsibilities associated with
the additional development of VIVITROL, including regulatory
approval and costs. We are currently conducting
a randomized, multi-center registration study of VIVITROL in Russia for the treatment of opioid
dependence. Clinical data from this study will form the basis of a sNDA to the FDA for VIVITROL
for the treatment of opioid dependence. However, there is no assurance that the data from this
study or any clinical or preclinical data will be sufficient to gain regulatory approval of
VIVITROL for opioid dependence in the U.S. or other countries. Approval of VIVITROL
for alcohol dependence in countries outside of the U.S., except for Russia and other
countries in the CIS, and approval of VIVITROL for other indications in the U.S. and
countries outside of the U.S. will depend on our sponsoring such efforts ourselves,
including conducting additional clinical studies, which can be very
costly, or entering into co-development, co-promotion or sales and marketing agreements with collaborators.
Our customer base for VIVITROL is highly concentrated.
Our principal customers for VIVITROL are wholesale drug distributors. These customers comprise
a significant part of the distribution network for pharmaceutical products in the U.S.
Three large wholesale distributors, Cardinal Health, Inc., McKesson Corporation and
AmerisourceBergen Corporation, control a significant share of this network. Fluctuations in the
buying patterns of these customers, which may result from seasonality, wholesaler buying decisions
or other factors outside of our control, could significantly affect the level of our net sales on a
period-to-period basis. The impact on net sales could have a material
impact on our financial condition, cash flows and results of
operations.
In
an effort to combat the fluctuations in the buying patterns and the
potential harm to our financial condition, we intend to enter into
wholesaler distribution service agreements, (DSAs), with
our three
largest wholesale drug distributors. Under the DSAs, we would pay the wholesalers a fee to maintain
certain minimum inventory levels that gradually decline over several quarters. We believe
it is beneficial to enter into DSAs to establish specified levels of product inventory to be
maintained by our wholesalers and to obtain more precise information as to the level of our product
inventory available throughout the product distribution channel. We cannot be certain that the DSAs
will be effective in limiting speculative purchasing activity, that there will not be a future
drawdown of inventory as a result of declining minimum inventory requirements, or otherwise, or
that the inventory level data provided through our DSAs are accurate. If speculative purchasing
does occur, if the wholesalers significantly decrease their
32
inventory levels, or if inventory level data provided through DSAs is inaccurate, our
business, financial condition, cash flows and results of operations may also be adversely affected.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
A
summary of our stock repurchase activity for the three months ended December 31, 2008 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Approximate Dollar |
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
Value of Shares that |
|
|
|
Total Number |
|
|
Average |
|
|
Purchased as |
|
|
May Yet be Purchased |
|
|
|
of Shares |
|
|
Price Paid |
|
|
Part of a Publicly |
|
|
Under the Program |
|
Period |
|
Purchased (a) |
|
|
per Share |
|
|
Announced Program (a) |
|
|
(in millions) |
|
October 1 through October 31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108.6 |
|
November 1 through November 30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
108.6 |
|
December 1 through December 31 |
|
|
487,300 |
|
|
|
9.99 |
|
|
|
487,300 |
|
|
$ |
103.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
487,300 |
|
|
$ |
9.99 |
|
|
|
487,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
In November 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. The repurchase program has no set
expiration date and may be suspended or discontinued at any time. We publicly announced the share
repurchase program in our press release dated November 21, 2007. In June 2008, the board of
directors authorized the expansion of this repurchase program by an additional $40.0 million,
bringing the total authorization under this program to $215.0 million. We publicly announced the
expansion of the repurchase program in our press release dated June 16, 2008. |
In addition to the stock repurchases above, during the three and nine months ended December
31, 2008, we acquired, by means of net share settlements, 16,339 and 51,871 shares of Alkermes
common stock, at an average price of $8.55 and $11.39 per share, respectively, related to the
vesting of employee stock awards to satisfy withholding tax obligations. In addition, during the
nine months ended December 31, 2008, we acquired 9,176 shares of Alkermes common stock, at an
average price of $12.66 per share, tendered by employees as payment of the exercise price of stock
options granted under our equity compensation plans.
Item 4. Submission of Matters to a Vote of Security Holders
We held our annual meeting of shareholders on October 7, 2008. The following proposals were
voted upon at the meeting:
|
1. |
|
A proposal to elect ten members to the board of directors, each to serve until the next
annual meeting of shareholders and until his or her successor is duly elected and qualified,
was approved with the following vote: |
|
|
|
|
|
|
|
|
|
|
|
|
Authority |
Nominee |
|
Votes For |
|
Withheld |
Floyd E. Bloom |
|
|
74,430,211 |
|
|
15,422,831 |
Robert A. Breyer |
|
|
73,993,424 |
|
|
15,859,618 |
Geraldine Henwood |
|
|
74,755,604 |
|
|
15,097,438 |
Paul J. Mitchell |
|
|
73,167,273 |
|
|
16,685,769 |
Richard F. Pops |
|
|
73,985,663 |
|
|
15,867,379 |
Alexander Rich |
|
|
72,842,293 |
|
|
17,010,749 |
David A. Broecker |
|
|
74,183,909 |
|
|
15,669,133 |
Mark B. Skaletsky |
|
|
72,838,407 |
|
|
17,014,635 |
Michael A. Wall |
|
|
69,941,022 |
|
|
19,912,020 |
David W. Anstice |
|
|
88,613,546 |
|
|
1,239,496 |
|
2. |
|
A proposal to approve the Alkermes 2008 Stock Option and Incentive Plan was approved with
57,876,227 votes for, 23,164,456 votes against, 74,496 abstentions and 8,737,863 broker
non-votes. |
33
|
3. |
|
A proposal to ratify PricewaterhouseCoopers LLP as our independent registered public
accountants for fiscal year 2009 was approved with 88,932,454 votes for, 854,501 votes
against and 66,087 abstentions. |
Item 5. Other Information
The Companys policy governing transactions in its securities by its directors, officers and
employees permits its officers, directors and employees to enter into trading plans in accordance
with Rule 10b5-1 under the Exchange Act. During the three months ended December 31, 2008, Mr. Floyd
E. Bloom, a director of the Company, and Mr. Gordon G. Pugh, an executive officer of the Company,
each 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
(a) List of Exhibits:
|
|
|
Exhibit |
|
|
No. |
|
|
10.1
|
|
Alkermes, Inc., 2008 Stock Option and Incentive Plan (incorporated
by reference to Exhibit 10.1 to the Registrants Report on Form
8-K filed on October 7, 2008). |
|
|
|
10.2
|
|
Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option
Award Certificate (Incentive Stock Option) (incorporated by
reference to Exhibit 10.2 to the Registrants Report on Form 8-K
filed on October 7, 2008). |
|
|
|
10.3
|
|
Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option
Award Certificate (Non-Qualified Option) (incorporated by
reference to Exhibit 10.3 to the Registrants Report on Form 8-K
filed on October 7, 2008). |
|
|
|
10.4
|
|
Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option
Award Certificate (Non-Employee Director) (incorporated by
reference to Exhibit 10.4 to the Registrants Report on Form 8-K
filed on October 7, 2008). |
|
10.5
|
|
Amendment to Employment Agreement by and between Alkermes, Inc.
and Richard F. Pops (incorporated by reference to Exhibit 10.5 to
the Registrants Report on Form 8-K filed on October 7, 2008). |
|
|
|
10.6
|
|
Amendment to Employment Agreement by and between Alkermes, Inc.
and David A. Broecker (incorporated by reference to Exhibit 10.6
to the Registrants Report on Form 8-K filed on October 7, 2008). |
|
|
|
10.7
|
|
Form of Amendment to Employment Agreement by and between Alkermes,
Inc. and each of each of Kathryn L. Biberstein, Elliot W. Ehrich,
M.D., James M. Frates, Michael J. Landine, Gordon G. Pugh
(incorporated by reference to Exhibit 10.7 to the Registrants
Report on Form 8-K filed on October 7, 2008). |
|
|
|
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). |
34
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
ALKERMES, INC.
(Registrant)
|
|
|
By: |
/s/ David A. Broecker
|
|
|
|
David A. Broecker |
|
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
By: |
/s/ James M. Frates
|
|
|
|
James M. Frates |
|
|
|
Senior Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
|
Date: February 9, 2009
35
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No. |
|
|
10.1
|
|
Alkermes, Inc., 2008 Stock Option and Incentive Plan (incorporated
by reference to Exhibit 10.1 to the Registrants Report on Form
8-K filed on October 7, 2008). |
|
|
|
10.2
|
|
Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option
Award Certificate (Incentive Stock Option) (incorporated by
reference to Exhibit 10.2 to the Registrants Report on Form 8-K
filed on October 7, 2008). |
|
|
|
10.3
|
|
Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option
Award Certificate (Non-Qualified Option) (incorporated by
reference to Exhibit 10.3 to the Registrants Report on Form 8-K
filed on October 7, 2008). |
|
|
|
10.4
|
|
Alkermes, Inc. 2008 Stock Option and Incentive Plan, Stock Option
Award Certificate (Non-Employee Director) (incorporated by
reference to Exhibit 10.4 to the Registrants Report on Form 8-K
filed on October 7, 2008). |
|
|
|
10.5
|
|
Amendment to Employment Agreement by and between Alkermes, Inc.
and Richard F. Pops (incorporated by reference to Exhibit 10.5 to
the Registrants Report on Form 8-K filed on October 7, 2008). |
|
|
|
10.6
|
|
Amendment to Employment Agreement by and between Alkermes, Inc.
and David A. Broecker (incorporated by reference to Exhibit 10.6
to the Registrants Report on Form 8-K filed on October 7, 2008). |
|
|
|
10.7
|
|
Form of Amendment to Employment Agreement by and between Alkermes,
Inc. and each of each of Kathryn L. Biberstein, Elliot W. Ehrich,
M.D., James M. Frates, Michael J. Landine, Gordon G. Pugh
(incorporated by reference to Exhibit 10.7 to the Registrants
Report on Form 8-K filed on October 7, 2008). |
|
|
|
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). |
36