e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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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 June 30, 2010
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 1-14131
ALKERMES, INC.
(Exact name of registrant as specified in its charter)
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PENNSYLVANIA
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23-2472830 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
852 Winter Street, Waltham, MA 02451
(781) 609-6000
(Address, including zip code, and telephone number, including
area code, of registrants principal executive offices)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files):
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer. 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 August 3, |
Class |
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2010 |
Common Stock, $.01 par value |
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95,106,462 |
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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
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2010
INDEX
2
PART 1. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
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June 30, |
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March 31, |
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2010 |
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2010 |
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(In thousands, except share and per |
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share amounts) |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
$ |
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89,994 |
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$ |
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79,324 |
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Investments short-term |
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202,197 |
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202,053 |
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Receivables |
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24,266 |
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25,316 |
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Inventory |
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20,472 |
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20,653 |
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Prepaid expenses and other current assets |
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10,501 |
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10,936 |
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Total current assets |
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347,430 |
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338,282 |
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PROPERTY, PLANT AND EQUIPMENT, NET |
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97,896 |
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96,905 |
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INVESTMENTS LONG-TERM |
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36,332 |
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68,816 |
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OTHER ASSETS |
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10,083 |
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11,597 |
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TOTAL ASSETS |
$ |
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491,741 |
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$ |
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515,600 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable and accrued expenses |
$ |
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29,311 |
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$ |
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37,881 |
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Deferred revenue current |
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1,862 |
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2,220 |
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Non-Recourse RISPERDAL® CONSTA® Secured 7% Notes Current |
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44,750 |
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51,043 |
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Total current liabilities |
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75,923 |
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91,144 |
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DEFERRED REVENUE LONG-TERM |
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5,054 |
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5,105 |
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OTHER LONG-TERM LIABILITIES |
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7,214 |
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6,735 |
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Total liabilities |
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88,191 |
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102,984 |
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COMMITMENTS AND CONTINGENCIES (Note 12) |
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SHAREHOLDERS EQUITY: |
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Common stock, par value, $0.01 per share; 160,000,000 shares authorized;
105,146,630 and 104,815,328 shares issued; 95,104,917 and 94,870,063 shares
outstanding at June 30, 2010 and March 31, 2010, respectively |
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1,049 |
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1,047 |
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Non-voting common stock, par value, $0.01 per share; 450,000 shares authorized;
382,632 shares issued and outstanding at June 30, 2010 and March 31, 2010 |
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4 |
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4 |
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Treasury stock, at cost (10,041,713 and 9,945,265 shares at June 30, 2010 and
March 31, 2010, respectively) |
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(130,778 |
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(129,681 |
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Additional paid-in capital |
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915,270 |
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910,326 |
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Accumulated other comprehensive loss |
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(2,898 |
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(3,392 |
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Accumulated deficit |
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(379,097 |
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(365,688 |
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Total shareholders equity |
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403,550 |
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412,616 |
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TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ |
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491,741 |
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$ |
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515,600 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
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Three Months Ended |
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June 30, |
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2010 |
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2009 |
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(In thousands, except per share |
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amounts) |
REVENUES: |
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Manufacturing revenues |
$ |
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26,891 |
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$ |
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28,804 |
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Royalty revenues |
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8,917 |
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8,701 |
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Product sales, net |
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6,204 |
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4,226 |
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Research and development revenue under collaborative arrangements |
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268 |
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1,450 |
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Net collaborative profit |
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- |
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4,315 |
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Total revenues |
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42,280 |
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47,496 |
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EXPENSES: |
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Cost of goods manufactured and sold |
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12,665 |
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12,666 |
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Research and development |
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22,977 |
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25,586 |
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Selling, general and administrative |
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19,726 |
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19,268 |
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Total expenses |
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55,368 |
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57,520 |
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OPERATING LOSS |
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(13,088 |
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(10,024 |
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OTHER EXPENSE, NET: |
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Interest income |
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852 |
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1,561 |
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Interest expense |
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(1,130 |
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(1,709 |
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Other expense, net |
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(101 |
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(63 |
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Total other expense, net |
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(379 |
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(211 |
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LOSS BEFORE INCOME TAXES |
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(13,467 |
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(10,235 |
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INCOME TAX BENEFIT |
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(58 |
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(70 |
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NET LOSS |
$ |
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(13,409 |
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$ |
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(10,165 |
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LOSS PER COMMON SHARE: |
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Basic and diluted |
$ |
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(0.14 |
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$ |
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(0.11 |
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: |
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Basic and diluted |
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95,326 |
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94,883 |
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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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Three Months Ended |
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June 30, |
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2010 |
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2009 |
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(In thousands) |
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
$ |
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(13,409 |
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$ |
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(10,165 |
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Adjustments to reconcile net loss to cash flows from operating activities: |
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Depreciation |
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2,105 |
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9,948 |
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Share-based compensation expense |
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4,456 |
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3,230 |
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Other non-cash charges |
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146 |
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481 |
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Changes in assets and liabilities: |
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Receivables |
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1,050 |
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(3,311 |
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Inventory, prepaid expenses and other assets |
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2,051 |
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1,167 |
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Accounts payable and accrued expenses |
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(8,202 |
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(11,882 |
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Deferred revenue |
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(409 |
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(4,192 |
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Other long-term liabilities |
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4 |
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(427 |
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Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal
attributable to original issue discount |
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(650 |
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(485 |
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Cash flows used in operating activities |
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(12,858 |
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(15,636 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchase of property, plant and equipment |
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(4,336 |
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(2,099 |
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Sales of property, plant and equipment |
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30 |
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23 |
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Purchases of investments |
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(102,790 |
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(203,655 |
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Sales and maturities of investments |
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135,917 |
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187,712 |
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Cash flows provided by (used in) investing activities |
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28,821 |
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(18,019 |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from the issuance of common stock for share-based compensation
arrangements |
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474 |
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107 |
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Payment of non-recourse RISPERDAL CONSTA secured 7% notes principal |
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(5,767 |
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(5,932 |
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Purchase of common stock for treasury |
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- |
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(2,513 |
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Cash flows used in financing activities |
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(5,293 |
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(8,338 |
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NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS |
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10,670 |
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(41,993 |
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CASH AND CASH EQUIVALENTS Beginning of period |
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79,324 |
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86,893 |
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CASH AND CASH EQUIVALENTS End of period |
$ |
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89,994 |
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$ |
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44,900 |
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SUPPLEMENTAL CASH FLOW DISCLOSURE: |
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Cash paid for interest |
$ |
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898 |
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$ |
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1,348 |
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Cash paid for taxes |
$ |
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31 |
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$ |
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- |
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Non-cash investing and financing activities: |
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Purchased capital expenditures included in accounts payable and accrued expenses |
$ |
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1,635 |
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$ |
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713 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
Alkermes, Inc. (the Company or Alkermes) is a fully integrated biotechnology company
committed to developing innovative medicines to improve patients lives. The Company developed,
manufactures and commercializes VIVITROL for alcohol dependence and manufactures RISPERDAL CONSTA
for schizophrenia and bipolar I disorder. The Companys pipeline includes extended-release
injectable and oral products for the treatment of prevalent, chronic diseases, such as central
nervous system (CNS), disorders, reward disorders, addiction, diabetes and autoimmune disorders.
The Company is headquartered in Waltham, Massachusetts and has a research facility in Massachusetts
and a commercial manufacturing facility in Ohio.
The accompanying condensed consolidated financial statements of Alkermes for the three months
ended June 30, 2010 and 2009 are unaudited and have been prepared on a basis substantially
consistent with the audited financial statements for the year ended March 31, 2010. The year-end
condensed consolidated balance sheet data was derived from audited financial statements, but does
not include all disclosures required by accounting principles generally accepted in the United
States of America (U.S.) (commonly referred to as GAAP). In the opinion of management, the
condensed consolidated financial statements include all adjustments, which are of a normal
recurring nature, that are necessary to present fairly the results of operations for the reported
periods.
These financial statements should be read in conjunction with the Companys audited
consolidated financial statements and notes thereto which are contained in the Companys Annual
Report on Form 10-K for the year ended March 31, 2010, filed with the Securities and Exchange
Commission (SEC).
The results of the Companys operations for any interim period are not necessarily indicative
of the results of the Companys operations for any other interim period or for a full fiscal year.
Principles of Consolidation The condensed consolidated financial statements include the
accounts of Alkermes, Inc. and its wholly-owned subsidiaries: Alkermes Controlled Therapeutics,
Inc.; Alkermes Europe, Ltd.; and RC Royalty Sub LLC (Royalty Sub). The assets of Royalty Sub are
not available to satisfy obligations of Alkermes and its subsidiaries, other than the obligations
of Royalty Sub, including Royalty Subs non-recourse RISPERDAL CONSTA secured 7% notes (the
non-recourse 7% Notes), and the assets of Alkermes are not available to satisfy obligations of
Royalty Sub. Intercompany accounts and transactions have been eliminated. On July 1, 2010, in
addition to a scheduled principal payment of $6.4 million, the Company redeemed the non-recourse 7%
Notes in full in exchange for $39.2 million, which was 101.75% of the outstanding principal balance
in accordance with the provisions of the purchase and sales agreement.
Use of Estimates The preparation of the Companys condensed consolidated financial
statements in conformity with GAAP necessarily requires management to make estimates and
assumptions that affect the following: (1) reported amounts of assets and liabilities; (2)
disclosure of contingent assets and liabilities at the date of the condensed consolidated financial
statements; and (3) the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from these estimates.
Segment Information The Company operates as one business segment, which is the business of
developing, manufacturing and commercializing innovative medicines designed to yield better
therapeutic outcomes and improve the lives of patients with serious diseases. The Companys chief
decision maker, the Chairman, President and Chief Executive Officer, reviews the Companys
operating results on an aggregate basis and manages the Companys operations as a single operating
unit.
6
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
New Accounting Pronouncements
In September 2009, the Emerging Issues Task Force (EITF) of the Financial Accounting
Standards Board (FASB) issued accounting guidance related to revenue recognition that amends the
previous guidance on arrangements with multiple deliverables. The new guidance provides accounting
principles and application guidance on whether multiple deliverables exist, how the arrangement
should be separated, and the products and services and instead provides for separate revenue
recognition based upon managements estimate of the selling price for an undelivered item when
there is no other means to determine the fair value of that undelivered item. Accounting guidance
previously required that the fair value of the undelivered item be the price of the item either
sold in a separate transaction between unrelated third parties or the price charged for each item
when the item is sold separately by the vendor. This was difficult to determine when the product
was not individually sold because of its unique features. Under the previous guidance, if the fair
value of all of the elements in the arrangement was not determinable, then revenue was deferred
until all of the items were delivered or fair value was determined. This guidance is effective
prospectively for revenue arrangements entered into or materially modified in the Companys fiscal
year beginning April 1, 2011, and the Company is currently evaluating the potential impact of this
standard on its consolidated financial statements. Early adoption is permitted; however, adoption
of this guidance as of a date other than April 1, 2011 will require the Company to apply this
guidance retrospectively effective as of April 1, 2010, and will require disclosure of the effect
of this guidance as applied to all previously reported interim periods in the fiscal year of
adoption.
In January 2010, the FASB issued accounting guidance related to fair value measurements that
requires additional disclosure related to transfers in and out of Levels 1 and 2 of the fair value
hierarchy. The guidance also requires additional disclosure for activity within Level 3 of the fair
value hierarchy. The guidance requires a reporting entity to disclose separately the amounts of
significant transfers in and out of Level 1 and Level 2 and describe the reasons for the transfers.
In addition, this guidance requires a reporting entity to present separately information about
purchases, sales issuances and settlements in the reconciliation for fair value measurements using
significant unobservable inputs, or Level 3. This accounting standard was effective for interim and
annual reporting periods beginning after December 31, 2009, other than for disclosures about
purchases, sales, issuances and settlements in the roll forward of activity in Level 3 fair value
measurements. Those disclosures are effective for fiscal years beginning after December 31, 2010
and for interim periods within those fiscal years. The Company adopted all provisions of this
pronouncement, except for those related to the disclosure of disaggregated Level 3 activity, on
January 1, 2010, and as this guidance only amends required disclosures in the Companys condensed
consolidated financial statements, it did not have an effect upon the Companys financial position
or results of operations. The Company does not expect the adoption of the remaining provisions of
this amendment to have a significant impact on its consolidated financial statements.
In April 2010, the FASB issued accounting guidance related to the milestone method of revenue
recognition for research and development arrangements. Under this guidance, the Company may
recognize revenue contingent upon the achievement of a milestone in its entirety, in the period in
which the milestone is achieved, only if the milestone meets all the criteria within the guidance
to be considered substantive. This guidance is effective on a prospective basis for research and
development milestones achieved in the Companys fiscal year beginning April 1, 2011. Early
adoption is permitted; however, adoption of this guidance as of a date other than April 1, 2011
will require the Company to apply this guidance retrospectively effective as of April 1, 2010, and
will require disclosure of the effect of this guidance as applied to all previously reported
interim periods in the fiscal year of adoption. The Company plans to implement this guidance
prospectively and the effect of this guidance will be limited to future transactions. The Company
does not expect adoption of this standard to have a material impact on its financial position or
results of operations.
7
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. COMPREHENSIVE LOSS
Comprehensive loss is as follows:
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Three Months Ended |
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June 30, |
(In thousands) |
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2010 |
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2009 |
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Net loss |
$ |
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(13,409 |
) |
$ |
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(10,165 |
) |
Unrealized gains on available-for-sale securities: |
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Holding gains, net of tax |
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494 |
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1,988 |
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Unrealized gains on available-for-sale securities |
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494 |
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1,988 |
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Comprehensive loss |
$ |
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(12,915 |
) |
$ |
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(8,177 |
) |
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3. LOSS PER SHARE
Basic loss per common share is calculated based upon net loss available to holders of common
shares divided by the weighted average number of shares outstanding. For the three months ended
June 30, 2010 and 2009, as the Company was in a net loss position, the diluted loss per share does
not assume conversion or exercise of stock options and awards as they would have an anti-dilutive
effect on loss per share. Therefore, the weighted average of basic and diluted voting shares of
common stock outstanding for the three months ended June 30, 2010 and 2009 were 95,326,137 and
94,883,071, respectively.
The following amounts are not included in the calculation of diluted loss per common share
because their effects are anti-dilutive:
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Three Months Ended |
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June 30, |
(In thousands) |
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2010 |
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2009 |
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Stock options |
|
|
13,768 |
|
|
|
17,444 |
|
Restricted stock units |
|
|
795 |
|
|
|
254 |
|
|
|
|
|
|
Total |
|
|
14,563 |
|
|
|
17,698 |
|
|
|
|
|
|
8
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. INVESTMENTS
Investments consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross Unrealized |
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses |
|
|
|
|
|
Amortized |
|
|
|
|
|
Less than |
|
Greater than |
|
Estimated |
|
|
Cost |
|
Gains |
|
One Year |
|
One Year |
|
Fair Value |
|
|
(In thousands) |
|
June 30, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
$ |
|
173,578 |
|
$ |
|
413 |
|
$ |
|
- |
|
$ |
|
- |
|
$ |
|
173,991 |
|
International government agency debt securities |
|
|
18,090 |
|
|
|
172 |
|
|
|
- |
|
|
|
- |
|
|
|
18,262 |
|
Corporate debt securities |
|
|
8,192 |
|
|
|
63 |
|
|
|
- |
|
|
|
- |
|
|
|
8,255 |
|
Asset backed debt securities |
|
|
492 |
|
|
|
- |
|
|
|
- |
|
|
|
(4 |
) |
|
|
488 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,352 |
|
|
|
648 |
|
|
|
- |
|
|
|
(4 |
) |
|
|
200,996 |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
1,201 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
201,553 |
|
|
|
648 |
|
|
|
- |
|
|
|
(4 |
) |
|
|
202,197 |
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
26,108 |
|
|
|
- |
|
|
|
- |
|
|
|
(1,038 |
) |
|
|
25,070 |
|
Auction rate securities |
|
|
5,000 |
|
|
|
- |
|
|
|
- |
|
|
|
(711 |
) |
|
|
4,289 |
|
Strategic equity investments |
|
|
644 |
|
|
|
472 |
|
|
|
- |
|
|
|
- |
|
|
|
1,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31,752 |
|
|
|
472 |
|
|
|
- |
|
|
|
(1,749 |
) |
|
|
30,475 |
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
5,440 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,440 |
|
U.S. government obligations |
|
|
417 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
37,609 |
|
|
|
472 |
|
|
|
- |
|
|
|
(1,749 |
) |
|
|
36,332 |
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
$ |
|
239,162 |
|
$ |
|
1,120 |
|
$ |
|
- |
|
$ |
|
(1,753 |
) |
$ |
|
238,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency debt securities |
$ |
|
160,876 |
|
$ |
|
204 |
|
$ |
|
- |
|
$ |
|
- |
|
$ |
|
161,080 |
|
International government agency debt securities |
|
|
23,441 |
|
|
|
136 |
|
|
|
- |
|
|
|
(1 |
) |
|
|
23,576 |
|
Corporate debt securities |
|
|
15,225 |
|
|
|
14 |
|
|
|
- |
|
|
|
(2 |
) |
|
|
15,237 |
|
Asset backed debt securities |
|
|
983 |
|
|
|
- |
|
|
|
- |
|
|
|
(24 |
) |
|
|
959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
200,525 |
|
|
|
354 |
|
|
|
- |
|
|
|
(27 |
) |
|
|
200,852 |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
1,201 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,201 |
|
|
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
|
201,726 |
|
|
|
354 |
|
|
|
- |
|
|
|
(27 |
) |
|
|
202,053 |
|
|
|
|
|
|
|
|
|
|
|
|
Long-term investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
26,109 |
|
|
|
- |
|
|
|
- |
|
|
|
(942 |
) |
|
|
25,167 |
|
U.S. government and agency debt securities |
|
|
24,727 |
|
|
|
- |
|
|
|
(39 |
) |
|
|
- |
|
|
|
24,688 |
|
Auction rate securities |
|
|
10,000 |
|
|
|
- |
|
|
|
- |
|
|
|
(1,454 |
) |
|
|
8,546 |
|
International government agency debt securities |
|
|
3,225 |
|
|
|
- |
|
|
|
(2 |
) |
|
|
- |
|
|
|
3,223 |
|
Strategic equity investments |
|
|
644 |
|
|
|
691 |
|
|
|
- |
|
|
|
- |
|
|
|
1,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64,705 |
|
|
|
691 |
|
|
|
(41 |
) |
|
|
(2,396 |
) |
|
|
62,959 |
|
|
|
|
|
|
|
|
|
|
|
|
Held-to-maturity securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
|
|
5,440 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,440 |
|
U.S. government obligations |
|
|
417 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
417 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,857 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term investments |
|
|
70,562 |
|
|
|
691 |
|
|
|
(41 |
) |
|
|
(2,396 |
) |
|
|
68,816 |
|
|
|
|
|
|
|
|
|
|
|
|
Total investments |
$ |
|
272,288 |
|
$ |
|
1,045 |
|
$ |
|
(41 |
) |
$ |
|
(2,423 |
) |
$ |
|
270,869 |
|
|
|
|
|
|
|
|
|
|
|
|
The proceeds from the sales and maturities of marketable securities, excluding strategic
equity investments, which were primarily reinvested and resulted in realized gains and losses, were
as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
Proceeds from the sales and maturities of marketable securities |
$ |
|
135,917 |
|
$ |
|
187,712 |
|
Realized gains |
$ |
|
37 |
|
$ |
|
186 |
|
Realized losses |
$ |
|
18 |
|
$ |
|
1 |
|
9
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The Companys available-for-sale and held-to-maturity securities at June 30, 2010 have
contractual maturities in the following periods:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-Sale |
|
Held-to-Maturity |
|
|
Amortized |
|
Estimated |
|
Amortized |
|
Estimated |
(in thousands) |
|
Cost |
|
Fair Value |
|
Cost |
|
Fair Value |
|
|
|
|
|
|
|
|
|
Within 1 year |
$ |
|
69,512 |
|
$ |
|
69,557 |
|
$ |
|
5,857 |
|
$ |
|
5,857 |
|
After 1 year through 5 years (1) |
|
|
127,270 |
|
|
|
127,662 |
|
|
|
- |
|
|
|
- |
|
After 5 years through 10 years (1) |
|
|
29,678 |
|
|
|
28,847 |
|
|
|
- |
|
|
|
- |
|
After 10 years |
|
|
5,000 |
|
|
|
4,289 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total |
$ |
|
231,460 |
|
$ |
|
230,355 |
|
$ |
|
5,857 |
|
$ |
|
5,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Investments in available-for-sale securities within these categories,
with an amortized cost of $58.9 million and an estimated fair value of
$58.3 million, have issuer call dates prior to May 2011. |
At June 30, 2010, the Company believes that the unrealized losses on its available-for-sale
investments are temporary. The investments with unrealized losses consist primarily of corporate
debt securities and an auction rate security. In making the determination that the decline in fair
value of these securities was temporary, the Company considered various factors, including but not
limited to: the length of time each security was in an unrealized loss position; the extent to
which fair value was less than cost; financial condition and near term prospects of the issuers;
and the Companys intent not to sell these securities and the assessment that it is more likely
than not that the Company would not be required to sell these securities before the recovery of
their amortized cost basis.
The Companys strategic equity investments include common stock in public companies with which
the Company has or had a collaborative arrangement with.
The Company also has an $8.0 million investment in a collaborative
partner, Acceleron Pharma, Inc. (Acceleron), which is
recorded within Other assets in the accompanying
condensed consolidated balance sheets at June 30, 2010 and March 31,
2010. The Company accounts for its investment in Acceleron under the
cost method as Acceleron is a privately-held company over which the
Company does not exercise significant influence. The Company will
continue to monitor this investment to evaluate whether any decline
in its value has occurred that would be other-than-temporary, based
on the implied value from any recent rounds of financing completed by
Acceleron, market prices of comparable public companies and general
market conditions.
5. FAIR VALUE MEASUREMENTS
The following table presents information about the Companys assets that are measured at fair
value on a recurring basis and indicates the fair value hierarchy of the valuation techniques the
Company utilized to determine such fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
|
|
|
|
(In thousands) |
|
2010 |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
|
|
|
|
|
|
|
|
Cash equivalents and money market funds |
$ |
|
1,301 |
|
$ |
|
1,301 |
|
$ |
|
- |
|
$ |
|
- |
|
U.S. government and agency debt securities |
|
|
173,991 |
|
|
|
173,991 |
|
|
|
- |
|
|
|
- |
|
International government agency debt securities |
|
|
18,262 |
|
|
|
18,262 |
|
|
|
- |
|
|
|
- |
|
Corporate debt securities |
|
|
33,325 |
|
|
|
- |
|
|
|
31,589 |
|
|
|
1,736 |
|
Auction rate securities |
|
|
4,289 |
|
|
|
- |
|
|
|
- |
|
|
|
4,289 |
|
Asset backed debt securities |
|
|
488 |
|
|
|
- |
|
|
|
- |
|
|
|
488 |
|
Strategic equity investments |
|
|
1,116 |
|
|
|
1,116 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total |
$ |
|
232,772 |
|
$ |
|
194,670 |
|
$ |
|
31,589 |
|
$ |
|
6,513 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
|
|
|
|
|
2010 |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
|
|
|
|
|
|
|
|
Cash equivalents and money market funds |
$ |
|
1,289 |
|
$ |
|
1,289 |
|
$ |
|
- |
|
$ |
|
- |
|
U.S. government and agency debt securities |
|
|
185,768 |
|
|
|
185,768 |
|
|
|
- |
|
|
|
- |
|
International government agency debt securities |
|
|
26,799 |
|
|
|
26,799 |
|
|
|
- |
|
|
|
- |
|
Corporate debt securities |
|
|
40,404 |
|
|
|
- |
|
|
|
38,668 |
|
|
|
1,736 |
|
Auction rate securities |
|
|
8,546 |
|
|
|
- |
|
|
|
- |
|
|
|
8,546 |
|
Asset backed debt securities |
|
|
959 |
|
|
|
- |
|
|
|
- |
|
|
|
959 |
|
Strategic equity investments |
|
|
1,335 |
|
|
|
1,335 |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total |
$ |
|
265,100 |
|
$ |
|
215,191 |
|
$ |
|
38,668 |
|
$ |
|
11,241 |
|
|
|
|
|
|
|
|
|
|
10
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
There were no transfers or reclassifications of any securities between Level 1 and Level
2 during the three months ended June 30, 2010. The following table illustrates the rollforward of
the fair value of the Companys investments whose fair value is determined using Level 3 inputs:
|
|
|
|
|
|
|
Fair |
|
(In thousands) |
|
Value |
|
|
|
|
Balance, March 31, 2010 |
$ |
|
11,241 |
|
Total unrealized gains included in comprehensive loss |
|
|
764 |
|
Sales and redemptions, at par value |
|
|
(5,492 |
) |
|
|
|
Balance, June 30, 2010 |
$ |
|
6,513 |
|
|
|
|
Substantially all of the Companys corporate debt securities have been classified as Level 2.
These securities have been initially valued at the transaction price and subsequently valued, at
the end of each reporting period, utilizing market observable data. The market observable data
includes reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers,
current spot rates and other industry and economic events. The Company validates the prices
developed using the market observable data by obtaining market values from other pricing sources,
analyzing pricing data in certain instances and confirming that the relevant markets are active.
The Company used a discounted cash flow model to determine the estimated fair value of its
Level 3 investments. The Companys most significant Level 3 investment at June 30, 2010 consists of
its investment in a student loan backed auction rate security, with an amortized cost of $5.0
million, which was not trading at June 30, 2010. The assumptions used in the discounted cash flow
model include estimates for interest rates, timing of cash flows, expected holding periods and risk
adjusted discount rates, which include provisions for default and liquidity risk, which the Company
believes to be the most critical assumptions utilized within the analysis. The valuation analysis
considers, among other items, assumptions that market participants would use in their estimates of
fair value, such as the collateral underlying the security, the creditworthiness of the issuer and
any associated guarantees, the timing of expected future cash flows, the timing of, and the
likelihood that the security will have a successful auction or when callability features may be
exercised by the issuer. The securities were also compared, where possible, to other observable
market data with similar characteristics to the securities held by the Company.
The carrying amounts reflected in the condensed consolidated balance sheets for cash and cash
equivalents, accounts receivable, other current assets, accounts payable and accrued expenses
approximate fair value due to their short-term nature. The Companys non-recourse 7% Notes had a
carrying value of $44.7 million and $51.0 million and a fair value of $44.9 million and
$48.7 million at June 30, 2010 and March 31, 2010, respectively. The estimated fair value of the
non-recourse 7% Notes at June 30, 2010 is equal to the outstanding principal amount as the
non-recourse 7% Notes were redeemed in full on July 1, 2010. The estimated fair value of the
non-recourse 7% Notes at March 31, 2010 was based on a discounted cash flow model.
6. INVENTORY
Inventory is stated at the lower of cost or market value. Cost is determined using the
first-in, first-out method. Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2010 |
|
|
|
|
|
|
Raw materials |
$ |
|
4,049 |
|
$ |
|
4,130 |
|
Work in process |
|
|
6,232 |
|
|
|
7,788 |
|
Finished goods (1) |
|
|
9,980 |
|
|
|
8,501 |
|
Consigned-out inventory (2) |
|
|
211 |
|
|
|
234 |
|
|
|
|
|
|
Total inventory |
$ |
|
20,472 |
|
$ |
|
20,653 |
|
|
|
|
|
|
|
|
|
(1) |
|
At June 30, 2010 and March 31, 2010, the Company had $0.7 million of
finished goods inventory located at its third party warehouse and
shipping service provider. |
|
(2) |
|
At June 30, 2010 and March 31, 2010, consigned-out inventory relates
to VIVITROL inventory in the distribution channel for which the
Company has not recognized revenue. |
11
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
7. PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2010 |
|
|
|
|
|
|
Land |
$ |
|
301 |
|
$ |
|
301 |
|
Building and improvements |
|
|
36,771 |
|
|
|
36,759 |
|
Furniture, fixture and equipment |
|
|
63,184 |
|
|
|
62,501 |
|
Leasehold improvements |
|
|
42,645 |
|
|
|
42,660 |
|
Construction in progress |
|
|
44,844 |
|
|
|
43,695 |
|
|
|
|
|
|
Subtotal |
|
|
187,745 |
|
|
|
185,916 |
|
Less: accumulated depreciation |
|
|
(89,849 |
) |
|
|
(89,011 |
) |
|
|
|
|
|
Total property, plant and equipment, net |
$ |
|
97,896 |
|
$ |
|
96,905 |
|
|
|
|
|
|
8. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
March 31, |
|
(In thousands) |
|
2010 |
|
|
2010 |
|
|
|
|
|
|
Accounts payable |
$ |
|
8,352 |
|
$ |
|
8,197 |
|
Accrued compensation |
|
|
7,580 |
|
|
|
15,276 |
|
Accrued other |
|
|
13,379 |
|
|
|
14,408 |
|
|
|
|
|
|
Total accounts payable and accrued expenses |
$ |
|
29,311 |
|
$ |
|
37,881 |
|
|
|
|
|
|
9. SHARE-BASED COMPENSATION
Share-based compensation expense consists of the following:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(In thousands) |
|
2010 |
|
|
2009 |
|
|
|
|
|
|
Cost of goods manufactured and sold |
$ |
|
361 |
|
$ |
|
310 |
|
Research and development |
|
|
1,515 |
|
|
|
807 |
|
Selling, general and administrative |
|
|
2,580 |
|
|
|
2,113 |
|
|
|
|
|
|
Total share-based compensation expense |
$ |
|
4,456 |
|
$ |
|
3,230 |
|
|
|
|
|
|
At June 30, 2010 and March 31, 2010, $0.6 million and $0.5 million, respectively, of
share-based compensation cost was capitalized and recorded as Inventory in the condensed
consolidated balance sheets.
10. RESTRUCTURING
In connection with the 2008 restructuring program, in which the Company and Eli Lilly and
Company announced the decision to discontinue the AIR ® Insulin development program (the
2008 Restructuring), the Company recorded net restructuring charges of approximately $6.9 million
in the year ended March 31, 2008. Activity related to the 2008 Restructuring in the three months
ended June 30, 2010 was as follows:
|
|
|
|
|
(In thousands) |
|
Balance |
|
|
|
|
Accrued restructuring, March 31, 2010 |
$ |
|
3,596 |
|
Payments for facility closure costs |
|
|
(239 |
) |
Other adjustments |
|
|
281 |
|
|
|
|
Accrued Restructuring, June 30, 2010 |
$ |
|
3,638 |
|
|
|
|
At June 30, 2010 and March 31, 2010, the restructuring liability related to the 2008
Restructuring consists of $0.6 million classified as current and $3.0 million classified as
long-term, respectively, in the accompanying
12
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
condensed consolidated balance sheets. As of June 30, 2010, the Company had paid in cash,
written off, recovered and made restructuring charge adjustments that totaled approximately
$0.3 million in facility closure costs, $2.9 million in employee separation costs and $0.2 million
in other contract termination costs in connection with the 2008 Restructuring. The $3.6 million
remaining in the restructuring accrual at June 30, 2010 is expected to be paid out through fiscal
2016 and relates primarily to future lease costs associated with an exited facility.
11. 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 June 30, 2010, the Company determined
that it is more likely than not that the deferred tax assets may not be realized and a full
valuation allowance continues to be recorded.
The Company recorded an income tax benefit of $0.1 million for the three months ended June 30,
2010, primarily related to the Companys recognition of $0.3 million of income tax expense recorded
as a discrete item within other comprehensive loss associated with the increase in the value of
certain securities that it carried at fair market value. The income tax benefit of $0.1 million for
the three months ended June 30, 2009 represented the amount the Company estimated it would benefit
from the Housing and Economic Recovery Act of 2008.
12. 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.
13. SUBSEQUENT EVENTS
On July 1, 2010, in addition to a scheduled principal payment of $6.4 million, the Company
redeemed the non-recourse 7% Notes in full in exchange for $39.2 million, which was 101.75% of the
outstanding principal balance in accordance with the provisions of the purchase and sales
agreement.
13
Item 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations
The following discussion should be read in conjunction with our condensed consolidated
financial statements and related notes beginning on page 5 of this Quarterly Report on Form 10-Q,
and the audited financial statements and notes thereto, and Managements Discussion and Analysis of
Financial Condition and Results of Operations included in our Annual Report on Form 10-K, which has
been filed with the Securities and Exchange Commission (SEC).
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® (naltrexone for extended-release injectable suspension) for alcohol dependence
and manufacture RISPERDAL® CONSTA® [(risperidone) long-acting injection] for
schizophrenia and bipolar I disorder. Our robust pipeline includes extended-release injectable and
oral products for the treatment of prevalent, chronic diseases, such as central nervous system
(CNS) disorders, reward disorders, addiction, diabetes and autoimmune disorders. We are
headquartered in Waltham, Massachusetts and have a research facility in Massachusetts and a
commercial manufacturing facility in Ohio.
We leverage our formulation expertise and proprietary product platforms to develop, both with
partners and on our own, innovative and competitively advantaged medications that can enhance
patient outcomes in major therapeutic areas. We enter into select collaborations with
pharmaceutical and biotechnology companies to develop significant new product candidates, based on
existing drugs and incorporating our proprietary product platforms. In addition, we apply our
innovative formulation expertise and drug development capabilities to create our own new,
proprietary pharmaceutical products.
Forward-Looking Statements
This document contains and incorporates by reference forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934. In some cases, these statements can be identified by the use of forward-looking
terminology such as may, will, could, should, would, expect, anticipate, continue
or other similar words. These statements discuss future expectations; contain projections of
results of operations or of financial condition, or state trends and known uncertainties or other
forward looking information. Forward-looking statements in this Quarterly Report on Form 10-Q
include, without limitation, statements regarding:
|
|
|
our expectations regarding our financial performance, including, but not limited to
revenues, expenses, gross margins, liquidity, capital expenditures and income taxes; |
|
|
|
our expectations regarding the commercialization of RISPERDAL CONSTA and VIVITROL
including the sales and marketing efforts of our partners Ortho-McNeil-Janssen
Pharmaceuticals, Inc. and Janssen Pharmaceutica International, a division of Cilag
International AG (Janssen), and our ability to establish and maintain successful sales
and marketing, reimbursement and distribution arrangements for VIVITROL; |
|
|
|
our expectation and timeline for regulatory approval of the New Drug Application (NDA)
submission for BYDUREONTM (exenatide for extended-release injectable suspension)
and, if approved, the commercialization of BYDUREON by Amylin Pharmaceuticals, Inc.
(Amylin), and Eli Lilly & Co. (Lilly); |
|
|
|
our expectation and timeline for regulatory approval of the supplemental NDA (sNDA)
submission for VIVITROL for the treatment of opioid dependence and, if approved, our
ability to commercialize VIVITROL in this new indication; |
|
|
|
our expectations regarding our product candidates, including the development, regulatory
review and commercial potential of such product candidates and the costs and expenses
related thereto; |
|
|
|
our expectations regarding the successful manufacture of our products and product
candidates, including RISPERDAL CONSTA and VIVITROL, by us at a commercial scale, and our
expectations regarding the successful manufacture of BYDUREON by our partner Amylin; |
|
|
|
the continuation of our collaborations and other significant agreements and our ability
to establish and maintain successful development collaborations; |
|
|
|
our expectations regarding the financial impact of recently enacted healthcare reform
legislation and |
14
|
|
|
foreign currency exchange rate fluctuations and valuations; |
|
|
|
the impact of new accounting pronouncements; |
|
|
|
our expectations concerning the status, intended use and financial impact of our
properties, including manufacturing facilities; and |
|
|
|
our future capital requirements and capital expenditures and our ability to finance our
operations and capital requirements. |
You are cautioned that forward-looking statements are based on current expectations and are
inherently uncertain. Actual performance and results of operations may differ materially from those
projected or suggested in the forward-looking statements due to various risks and uncertainties,
including:
|
|
|
manufacturing and royalty revenues from RISPERDAL CONSTA may not continue to grow,
particularly because we rely on our partner, Janssen, to forecast and market and sell this
product; |
|
|
|
we may be unable to manufacture RISPERDAL CONSTA, VIVITROL and our product candidates in
sufficient quantities and with sufficient yields to meet our and our partners
requirements; |
|
|
|
Amylin may not be able to successfully operate the manufacturing facility for BYDUREON; |
|
|
|
we may be unable to develop the commercial capabilities, and/or infrastructure,
necessary to successfully commercialize VIVITROL; |
|
|
|
the Food and Drug Administration, or FDA, and foreign regulatory agencies may not
approve BYDUREON or VIVITROL for opioid dependence and, even if approved, such products may
not be successfully commercialized; |
|
|
|
we rely on our collaborative partners to determine the regulatory and marketing
strategies for RISPERDAL CONSTA and BYDUREON, including the four-week formulation of
exenatide once weekly currently being developed by us, and our collaborators could elect to
terminate or delay programs at any time and disputes with collaborators or failure to
negotiate acceptable collaborative arrangements for our technologies could occur; |
|
|
|
RISPERDAL CONSTA, VIVITROL and BYDUREON, if and when approved, experience and will
continue to experience competition, including from competing products marketed by our
collaborative partners, such as INVEGA® SUSTENNATM (paliperidone palmitate), and from
marketing approvals for new products; |
|
|
|
third party payors may not cover or reimburse our products; |
|
|
|
the impact of recently enacted, and any future, health reform legislation may be greater
than initially expected; |
|
|
|
our product candidates could be ineffective or unsafe during preclinical studies and
clinical trials, and we and our collaborators may not be permitted by regulatory
authorities to undertake new or additional clinical trials for product candidates
incorporating our technologies, or clinical trials could be delayed or terminated; |
|
|
|
RISPERDAL CONSTA, VIVITROL, BYDUREON, if and when approved, 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; |
|
|
|
clinical trials may take more time or consume more resources than initially envisioned
and the results of earlier clinical trials may not necessarily be predictive of the safety
and efficacy results of larger clinical trials; |
|
|
|
U.S. and foreign regulatory agencies may refuse to accept applications for marketing
authorization for our product candidates, may request additional preclinical or clinical
studies be conducted or request a safety monitoring program, any of which could result in
significant delays or the failure of such products to receive marketing approval or
acceptance in the marketplace; |
|
|
|
difficulties in obtaining and enforcing our patents and difficulties with the patent
rights of others could occur; |
|
|
|
we may suffer potential costs resulting from product liability or other third party
claims; |
|
|
|
we may incur losses in the future; |
|
|
|
we may not be able to liquidate or otherwise recoup our investments in corporate debt
securities, asset backed debt securities and auction rate securities; |
|
|
|
exchange rate valuations and fluctuations may negatively impact our revenues, results of
operations and |
15
|
|
|
financial condition; and |
|
|
|
the risks and uncertainties described or discussed in Part 1, Item 1A, Risk Factors of
our Annual Report
on Form 10-K for the year ended March 31, 2010. |
The forward-looking statements contained and incorporated herein represent our judgment as of
the date of this Quarterly Report, and we caution readers not to place undue reliance on such
statements. The information contained in this Quarterly Report is provided by us as of the date of
this Quarterly Report, and, except as required by law, we do not undertake any obligation to update
any forward-looking statements contained in this document as a result of new information, future
events or otherwise.
Unless otherwise indicated, information contained in this Quarterly Report concerning the
disorders targeted by our products and product candidates and the markets in which we operate is
based on information from various sources (including industry publications, medical and clinical
journals and studies, surveys and forecasts and our internal research), on assumptions that we have
made, which we believe are reasonable, based on those data and other similar sources and on our
knowledge of the markets for our products and development programs. Our internal research has not
been verified by any independent source and we have not independently verified any third-party
information. These projections, assumptions and estimates are necessarily subject to a high degree
of uncertainty and risk due to a variety of factors, including those described in Part 1, Item 1A,
Risk Factors of our Annual Report on Form 10-K for the year ended March 31, 2010. These and other
factors could cause results to differ materially from those expressed in the estimates included in
this prospectus.
Financial Highlights
Net loss for the three months ended June 30, 2010 was $13.4 million, or $0.14 per common share
basic and diluted, as compared to a net loss of $10.2 million, or $0.11 per common share
basic and diluted for the three months ended June 30, 2009. Revenues for the three months ended
June 30, 2010 was driven by strong manufacturing and royalty revenues from RISPERDAL CONSTA.
Worldwide sales of RISPERDAL CONSTA by Janssen were $355.7 million, an increase of 2.3% from the
three months ended June 30, 2009.
Products and Development Programs
RISPERDAL CONSTA
RISPERDAL CONSTA is a long-acting formulation of risperidone, a product of Janssen, and is the
first and only long-acting, atypical antipsychotic approved by the United States (U.S.) Food and
Drug Administration (FDA), for the treatment of schizophrenia and for the treatment of bipolar I
disorder. The medication uses our proprietary Medisorb® injectable extended-release
technology to deliver and maintain therapeutic medication levels in the body through just one
injection every two weeks. RISPERDAL CONSTA is marketed by Janssen and is exclusively manufactured
by us. RISPERDAL CONSTA was first approved for the treatment of schizophrenia by regulatory
authorities in the United Kingdom and Germany in August 2002 and by the FDA in October 2003. The
Pharmaceuticals and Medical Devices Agency in Japan approved RISPERDAL CONSTA for the treatment of
schizophrenia in April 2009. RISPERDAL CONSTA is the first long-acting atypical antipsychotic to be
available in Japan. RISPERDAL CONSTA is approved for the treatment of schizophrenia in
approximately 85 countries and marketed in approximately 70 countries, and Janssen continues to
launch the product around the world.
Schizophrenia is a chronic, severe and disabling brain disorder. The disease is marked by
positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted
emotions and social withdrawal), as well as by disorganized thinking. An estimated 2.4 million
Americans have schizophrenia, with men and women affected equally. Worldwide, it is estimated that
one person in every 100 develops schizophrenia, one of the most serious types of mental illness.
Studies have demonstrated that as many as 75% of patients with schizophrenia have difficulty taking
their oral medication on a regular basis, which can lead to worsening of symptoms. Clinical data
have shown that treatment with RISPERDAL CONSTA may lead to improvements in symptoms, sustained
remission and decreases in hospitalization in patients with schizophrenia.
In May 2009, the FDA approved RISPERDAL CONSTA as both monotherapy and adjunctive therapy to
lithium or valproate in the maintenance treatment of bipolar I disorder. RISPERDAL CONSTA is also
approved for the maintenance treatment of bipolar I disorder in Canada, Australia and Saudi Arabia.
16
Bipolar disorder is a brain disorder that causes unusual shifts in a persons mood, energy and
ability to function. It is often characterized by debilitating mood swings, from extreme highs
(mania) to extreme lows (depression). Bipolar I disorder is characterized based on the occurrence
of at least one manic episode, with or without the occurrence of a major depressive episode.
Bipolar disorder is believed to affect approximately 5.7 million American adults, or about 2.6% of
the U.S. population age 18 and older, in a given year. The median age of onset for bipolar
disorders is 25 years. Clinical data have shown that RISPERDAL CONSTA significantly delayed the
time to relapse compared to placebo treatment in patients with bipolar I disorder.
VIVITROL
We developed VIVITROL, an extended-release Medisorb formulation of naltrexone, as the first
and only once-monthly injectable medication for the treatment of alcohol dependence. Alcohol
dependence is a serious and chronic brain disease characterized by cravings for alcohol, loss of
control over drinking, withdrawal symptoms and an increased tolerance for alcohol. According to the
National Institute on Alcohol Abuse and Alcoholisms 20012002 National Epidemiologic Survey on
Alcohol and Related Conditions, it is estimated that more than 18 million Americans suffer from
alcohol dependence. Adherence to medication is particularly challenging with this patient
population. In clinical trials, when used in combination with psychosocial support, VIVITROL was
shown to reduce the number of drinking days and heavy drinking days and to prolong abstinence in
patients who abstained from alcohol the week prior to starting treatment. VIVITROL was approved by
the FDA in April 2006 and was launched in the U.S. in June 2006 with our partner, Cephalon, Inc.
(Cephalon). In December 2008, we assumed responsibility for the commercialization of VIVITROL in
the U.S. from Cephalon. In December 2007, we exclusively licensed the right to commercialize
VIVITROL for the treatment of alcohol dependence and opioid dependence in Russia and other
countries in the Commonwealth of Independent States (CIS) to Cilag. In August 2008, the Russian
regulatory authorities approved VIVITROL for the treatment of alcohol dependence. Cilag launched
VIVITROL in Russia in March 2009. In March 2010, the FDA approved a Risk Evaluation and Mitigation
Strategy (REMS), for VIVITROL that consists of a Medication Guide and other customary REMS
assessment requirements.
We are also developing VIVITROL for the treatment of opioid dependence, a serious and chronic
brain disease characterized by compulsive, prolonged self-administration of opioid substances that
are not used for a medical purpose. According to the 2008 U.S. National Survey on Drug Use and
Health, an estimated 1.3 million people aged 18 or older were dependent on pain relievers or
heroin. In November 2009, we announced positive preliminary results from a phase 3 clinical trial
of VIVITROL for the treatment of opioid dependence. The six-month phase 3 study met its primary
efficacy endpoint (rate of opioid-free urine screens) and all secondary endpoints (study retention,
reduction in craving, self-reported opioid use as compared to placebo). VIVITROL was generally well
tolerated in the study and no patients on VIVITROL discontinued the study due to adverse events.
Based on these positive results, in April 2010, we submitted a sNDA for VIVITROL to the FDA for
approval as a treatment for opioid dependence. The FDA designated VIVITROL for the treatment of
opioid dependence as a priority review, which accelerates the FDAs target review timeline from ten
months to six months and issued a Prescription Drug User Fee Act (PDUFA) action date for the sNDA
of October 12, 2010.
In June 2010, the FDA notified us of the tentative scheduling of a Psychopharmacologic Drugs
Advisory Committee meeting on September 16, 2010 for review of our sNDA for VIVITROL for the
treatment of opioid dependence.
BYDUREON
We are collaborating with Amylin on the development of a once weekly formulation of exenatide,
called BYDUREON, for the treatment of type 2 diabetes. BYDUREON is an injectable formulation of
Amylins BYETTA® (exenatide) and is being developed with the goal of providing patients
with an effective and more patient-friendly treatment option. BYETTA is an injection administered
twice daily. Diabetes is a disease in which the body does not produce or properly use insulin.
Diabetes can result in serious health complications, including cardiovascular, kidney and nerve
disease. Diabetes is believed to affect more than 24 million people in the U.S. and an estimated
285 million adults worldwide. Approximately 90 95% of those affected have type 2 diabetes.
17
According to the Centers for Disease Control and Preventions National Health and Nutrition
Examination Survey, approximately 60% of people with diabetes do not achieve their target blood
sugar levels with their current
treatment regimen. In addition, 85% of type 2 diabetes patients are overweight and 55% are
considered obese. BYETTA was approved by the FDA in April 2005 as adjunctive therapy to improve
blood sugar control in patients with type 2 diabetes who have not achieved adequate control on
metformin and/or a sulfonylurea, which are commonly used oral diabetes medications. In December
2006, the FDA approved BYETTA as an add-on therapy for people with type 2 diabetes unable to
achieve adequate glucose control on thiazolidinediones, a class of diabetes medications. In October
2009, the FDA approved BYETTA as a stand-alone medication (monotherapy) along with diet and
exercise to improve glycemic control in adults with type 2 diabetes. Amylin has an agreement with
Lilly for the development and commercialization of exenatide, including BYDUREON.
In May 2009, Amylin submitted a NDA for BYDUREON to the FDA for the treatment of type 2
diabetes. The FDA accepted the submission in July 2009. In March 2010, the FDA issued a complete
response letter in reference to the NDA for BYDUREON. The complete response letter did not include
requests for new pre-clinical or clinical trials. Requests raised in the letter primarily related
to the finalization of the product labeling with accompanying REMS and clarification of existing
manufacturing processes. In April 2010, Amylin announced that it had submitted a response to the
FDAs complete response letter. In May 2010, the FDA accepted the response and issued a PDUFA
action date of October 22, 2010 for the NDA.
In April 2010, Lilly announced that the EMA had accepted the Marketing Authorization
Application filing for BYDUREON for the treatment of type 2 diabetes.
In June 2010, Amylin, Lilly and we announced results from DURATION-4, the fourth in a series
of studies designed to test the superiority of BYDUREON as compared to other type 2 diabetes
medications. This 26-week clinical study compared BYDUREON monotherapy to JANUVIA®,
ACTOS® (pioglitazone HCI) and metformin, three oral type 2 diabetes medications commonly
prescribed early in the treatment of type 2 diabetes. Study participants were not achieving
adequate A1C control using diet and exercise, and were not on any diabetes therapy when they
entered the study. A1C is a measure of average blood sugar over three months. The primary endpoint
was reduction in A1C, while secondary endpoints included change in body weight along with other
parameters of glucose control, cardiovascular health and patient-reported outcomes. After 26 weeks
of treatment, patients randomized to BYDUREON experienced a reduction in A1C of 1.5 percentage
points from baseline, which was significantly greater than the reduction of 1.2 percentage points
for JANUVIA. Patients randomized to metformin experienced a reduction in A1C of 1.5 percentage
points, and patients receiving ACTOS experienced a reduction of 1.6 percentage points. Patients
receiving BYDUREON, ACTOS and metformin treatment achieved an average A1C of less than 7 percent by
study end. Treatment with BYDUREON produced an average weight loss of 4.5 pounds, which was
statistically significantly greater than the average 1.7 pounds patients lost with JANUVIA and the
average 3.3 pounds patients gained with ACTOS. Patients receiving metformin experienced an average
weight loss of 4.4 pounds.
ALKS 33
ALKS 33 is an oral opioid modulator that we are developing for the potential treatment of
addiction and other CNS disorders. In November 2009, we initiated a phase 2 clinical study to
assess the safety and efficacy of multiple doses of ALKS 33 in patients with alcohol dependence and
to further define the clinical profile of ALKS 33.
In April 2010, we announced plans for the development of ALKS 33 for the treatment of
binge-eating disorder and as a combination therapy with buprenorphine for the treatment of
addiction and mood disorders. Binge-eating disorder is characterized by recurrent binge eating
episodes during which a person feels a loss of control over his or her eating. Unlike bulimia,
binge eating episodes are not followed by purging, excessive exercise or fasting. As a result,
people with binge-eating disorder often are overweight or obese. It is estimated that approximately
1% to 2% of Americans suffer from binge-eating disorder.
ALKS 37
We are developing ALKS 37, an orally active, peripherally-restricted opioid antagonist for the
treatment of opioid-induced constipation (OIC). According to IMS Health, over 243 million
prescriptions were written for
18
opioids in 2009 in the U.S. Many studies indicate that a high
percentage of patients receiving opioids are likely to experience side effects affecting
gastrointestinal motility. There are currently no available oral treatments for this
condition, which has severe quality of life implications. ALKS 37 is a component of ALKS 36,
which is discussed below.
In April 2010, we commenced a multicenter, randomized, double-blind, placebo-controlled,
multidose study designed to evaluate the efficacy, safety and tolerability of ALKS 37 in
approximately 60 patients with OIC. We expect to report preliminary results from the phase 2 study
of ALKS 37 in the first quarter of calendar 2011.
ALKS 36
In October 2009, we announced our intention to develop ALKS 36, which is expected to consist
of a co-formulation of an opioid analgesic and ALKS 37, for the treatment of pain without the side
effects of constipation. Research indicates that a high percentage of patients receiving opioids
are likely to experience side effects affecting gastrointestinal motility. A pain medication that
does not inhibit gastrointestinal motility, such as ALKS 36, could provide an advantage over
current therapies. The preliminary results from the phase 2 study of ALKS 37, which are expected in
the first quarter of calendar 2011, will inform further development of ALKS 36.
ALKS 9070
ALKS 9070 is a once-monthly, injectable, sustained-release version of aripiprazole for the
treatment of schizophrenia. ALKS 9070 is our first candidate to leverage our proprietary
LinkeRxTM product platform. Aripiprazole is commercially available under the name
ABILIFY® for the treatment of a number of CNS disorders. Based on encouraging
preclinical results, ALKS 9070 is expected to enter the clinic in the second half of calendar 2010.
ALKS 6931
ALKS 6931 is a long-acting form of a TNF receptor-FC fusion protein for the treatment of
rheumatoid arthritis and related autoimmune diseases. ALKS 6931 is our first candidate being
developed using the MedifusionTM technology licensed from Acceleron Pharma, Inc. ALKS
6931 is structurally similar to etanercept, commercially available under the name
ENBREL®.
ALKS 7921
ALKS 7921, the second candidate from the LinkeRx platform, is a once-monthly, injectable,
extended-release version of olanzapine for the treatment of schizophrenia. Olanzapine is
commercially available under the trade name ZYPREXA® (olanzapine). We are engineering
ALKS 7921 to prevent early, inadvertent release of free olanzapine into systemic circulation and,
in so doing, to provide another valuable option for patients and physicians to manage
schizophrenia.
19
Results of Operations
Manufacturing Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Manufacturing revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
$ |
|
26.3 |
|
$ |
|
27.9 |
|
$ |
|
(1.6 |
) |
Polymer |
|
|
0.6 |
|
|
|
0.9 |
|
|
|
(0.3 |
) |
|
|
|
|
|
|
|
Manufacturing revenues |
$ |
|
26.9 |
|
$ |
|
28.8 |
|
$ |
|
(1.9 |
) |
|
|
|
|
|
|
|
The decrease in RISPERDAL CONSTA manufacturing revenues for the three months ended June 30,
2010, as compared to the three months ended June 30, 2009, was primarily due to a 6% decrease in
the unit net sales price, partially offset by an increase in the number of units shipped to Janssen
of less than 1%. The decrease in the net unit sales price is primarily due to increased costs
incurred by Janssen as a result of healthcare reform in the U.S., as further described in Product
Sales, net, below and the strengthening of the U.S. dollar in relation to the foreign currencies in
which the product was sold. See Part I, Item 3. Quantitative and Qualitative Disclosures about
Market Risk for information on foreign currency exchange rate risk related to RISPERDAL CONSTA
revenues.
Under our manufacturing and supply agreement with Janssen, we earn manufacturing revenues when
product is shipped to Janssen, based on a percentage of Janssens estimated unit net sales price.
Revenues include a quarterly adjustment from Janssens estimated unit net sales price to Janssens
actual unit net sales price for product shipped. In the three months ended June 30, 2010 and 2009,
our RISPERDAL CONSTA manufacturing revenues were based on an average of 7.5% of Janssens unit net
sales price. We anticipate that we will continue to earn manufacturing revenues at 7.5% of
Janssens unit net sales price of RISPERDAL CONSTA for product shipped in the fiscal year ending
March 31, 2011 and beyond.
The decrease in polymer manufacturing revenues for the three months ended June 30, 2010, as
compared to the three months ended June 30, 2009, was primarily due to a 35% decrease in the amount
of polymer shipped to Amylin. We record manufacturing revenues under our arrangement with Amylin
for polymer sales at an agreed upon price when product is shipped to them. The polymer is used in
the formulation of BYDUREON.
Royalty Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Royalty revenues |
$ |
|
8.9 |
|
$ |
|
8.7 |
|
$ |
|
0.2 |
|
|
|
|
|
|
|
|
Substantially all of our royalty revenues for the three months ended June 30, 2010 and 2009
were related to sales of RISPERDAL CONSTA. Under our license agreements with Janssen, we record
royalty revenues equal to 2.5% of Janssens net sales of RISPERDAL CONSTA in the period that the
product is sold by Janssen. RISPERDAL CONSTA royalty revenues for the three months ended June 30,
2010 and 2009 were based on RISPERDAL CONSTA sales of $355.7 million and $347.8 million,
respectively. 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.
20
Product Sales, net
Our product sales consist of sales of VIVITROL in the U.S. to wholesalers, specialty
distributors and specialty pharmacies. The following table presents the adjustments deducted from
VIVITROL product sales, gross to arrive at VIVITROL product sales, net for sales of VIVITROL in the
U.S. during the three months ended June 30, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(In millions) |
|
2010 |
|
% of Sales |
|
|
2009 |
|
% of Sales |
|
Product sales, gross |
$ |
|
7.4 |
|
|
|
100.0 |
|
% |
$ |
|
5.4 |
|
|
|
100.0 |
|
% |
Adjustments to product sales, gross: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medicaid rebates |
|
|
(0.5 |
) |
|
|
(6.8 |
) |
% |
|
|
(0.2 |
) |
|
|
(3.7 |
) |
% |
Chargebacks |
|
|
(0.4 |
) |
|
|
(5.4 |
) |
% |
|
|
(0.1 |
) |
|
|
(1.8 |
) |
% |
Coupons |
|
|
- |
|
|
|
- |
|
% |
|
|
(0.3 |
) |
|
|
(5.6 |
) |
% |
Other |
|
|
(0.3 |
) |
|
|
(0.4 |
) |
% |
|
|
(0.6 |
) |
|
|
(11.1 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
|
(1.2 |
) |
|
|
(12.6 |
) |
% |
|
|
(1.2 |
) |
|
|
(22.2 |
) |
% |
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
$ |
|
6.2 |
|
|
|
87.4 |
|
% |
$ |
|
4.2 |
|
|
|
77.8 |
|
% |
|
|
|
|
|
|
|
|
|
|
|
The increase in product sales, gross for the three months ended June 30, 2010, as compared to
the three months ended June 30, 2009, was primarily due to a 19% increase in the number of units
sold and a 15% increase in price.
Our product sales may fluctuate from period to period as a result of factors such as end user
demand, which can create uneven purchasing patterns by our customers. Our product sales may also
fluctuate as the result of changes or adjustments to our reserves or changes in government or
customer rebates. For example, in March 2010, U.S. healthcare reform legislation was enacted which
contains several provisions that impact our business. Although many provisions of the new
legislation do not take effect immediately, several provisions became effective in the first
quarter of calendar 2010, including the following:
|
|
|
an increase in the minimum statutory Medicaid rebate to states participating in the
Medicaid program from 15.1% to 23.1%; |
|
|
|
an extension of the Medicaid rebate to drugs dispensed to Medicaid beneficiaries
enrolled with managed care organizations; and |
|
|
|
an expansion of the 340(B)/Public Health Services (PHS) drug pricing program, which
provides drugs at reduced rates, to include additional hospitals, clinics, and healthcare
centers in an outpatient setting. |
In addition, beginning in calendar 2011, we may incur our share of a new fee assessed on all
branded prescription drug manufacturers and importers. This fee will be calculated based upon
VIVITROLs percentage share of total branded prescription drug sales to U.S. government programs
(such as Medicare, Medicaid and Veterans Administration and Public Health Service discount
programs) made during the previous year. The aggregated industry-wide fee is expected to total $28
billion through 2019, ranging from $2.5 billion to $4.1 billion annually. Presently, uncertainty
exists as many of the specific determinations necessary to implement this new legislation have yet
to be decided and communicated to industry participants. For example, determinations as to how the
annual fee on branded prescription drugs will be calculated and allocated remain to be clarified,
though, as noted above, this provision will not be effective until calendar 2011.
We expect that during the remainder of fiscal year 2011 and into the future, our net sales as
a percentage of gross sales will be negatively affected as a result of certain aspects of the
recently enacted healthcare legislation, specifically, the increase in the minimum Medicaid
rebates, the expansion of those entities entitled to receive Medicaid rebates based on use of our
product (i.e. managed Medicaid), and the expansion of those entities entitled to purchase our
products at a discounted basis under the 340(B)/PHS drug pricing program. It is possible that the
effect of this legislation could further adversely impact our future revenues and we are still
assessing the full extent of this legislations future impact on our business.
21
Research and Development Revenue Under Collaborative Arrangements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Research and development revenue under
collaborative arrangements |
$ |
|
0.3 |
|
$ |
|
1.5 |
|
$ |
|
(1.2 |
) |
|
|
|
|
|
|
|
The decrease in research and development revenue under collaborative arrangements for the
three months ended June 30, 2010, as compared to the three months ended June 30, 2009, was
primarily due to the decision made by our collaborative partner, Johnson & Johnson Pharmaceutical
Research and Development, L.L.C. (J&JPRD) in August 2009 not to pursue further development of a
four week formulation of RISPERDAL CONSTA. The four week RISPERDAL CONSTA program contributed $1.1
million of revenue during the three months ended June 30, 2009.
Net Collaborative Profit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Net collaborative profit |
$ |
|
- |
|
$ |
|
4.3 |
|
$ |
|
(4.3 |
) |
|
|
|
|
|
|
|
Net collaborative profit for the three months ended June 30, 2009 consisted of revenue earned
as a result of the $11.0 million payment we received from Cephalon to fund their share of estimated
VIVITROL losses during the one-year period following the termination of the VIVITROL collaboration
in December 2008. We recorded the $11.0 million as deferred revenue and recognized it as revenue
through the application of a proportional performance model based on VIVITROL losses. The $11.0
million payment was fully recognized as revenue during the six months ended September 30, 2009.
Cost of Goods Manufactured and Sold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Cost of goods manufactured and sold: |
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
$ |
|
10.4 |
|
$ |
|
9.7 |
|
$ |
|
(0.7 |
) |
VIVITROL |
|
|
1.7 |
|
|
|
2.0 |
|
|
|
0.3 |
|
Polymer |
|
|
0.6 |
|
|
|
1.0 |
|
|
|
0.4 |
|
|
|
|
|
|
|
|
Cost of goods manufactured and sold |
$ |
|
12.7 |
|
$ |
|
12.7 |
|
$ |
|
(0.0 |
) |
|
|
|
|
|
|
|
The increase in cost of goods manufactured for RISPERDAL CONSTA in the three months ended June
30, 2010, as compared to the three months ended June 30, 2009, was primarily due to a 7% increase
in the unit cost of RISPERDAL CONSTA and an increase in the number of units shipped to Janssen of
less than 1%. The decrease in cost of goods manufactured and sold for VIVITROL in the three months
ended June 30, 2010, as compared to the three months ended June 30, 2009, was primarily due to a
$1.0 million reduction in costs incurred for failed batches and costs related to the restart of the
manufacturing line, partially offset by a 32% increase in the number of units sold out of the sales
channel. Included in cost of goods sold for VIVITROL during the three months ended June 30, 2010,
are idle capacity charges of $0.5 million which is the result of managing VIVITROL inventory levels
and reducing manufacturing output. The decrease in the cost of goods manufactured for polymer in
the three months ended June 30, 2010, as compared to the three months ended June 30, 2009, was
primarily due to a 35% decrease in the amount of polymer shipped to Amylin.
22
Research and Development Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Research and development |
$ |
|
23.0 |
|
$ |
|
25.6 |
|
$ |
|
2.6 |
|
|
|
|
|
|
|
|
The decrease in research and development (R&D) expenses in the three months ended June 30,
2010, as compared to the three months ended June 30, 2009, was primarily due to savings as a result
of the relocation of our corporate headquarters from Cambridge, Massachusetts, to Waltham,
Massachusetts. The move was completed during the fourth quarter of fiscal year 2010. Due to the
relocation, we incurred approximately $8.0 million of expense in the three months ended June 30,
2009 due to the acceleration of depreciation on laboratory related leasehold improvements and the
write-down of laboratory equipment located at our Cambridge facility. This decrease in expense was
partially offset by a $3.3 million increase in internal clinical and preclinical study expense and
a $1.5 million increase in reimbursements to our collaborative partners during the three months
ended June 30, 2010.
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 may be reimbursed to us by our partners. We account for our research and development
expenses on a departmental and functional basis in accordance with our budget and management
practices.
Selling, General and Administrative Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Selling, general and administrative |
$ |
|
19.7 |
|
$ |
|
19.3 |
|
$ |
|
(0.4 |
) |
|
|
|
|
|
|
|
Selling, general and administrative (SG&A) costs for the three months ended June 30, 2010
increased slightly compared to the three months ended June 30, 2009, due primarily to a $1.0
million increase in labor and benefit costs, an increase in occupancy costs allocated to SG&A of
$0.5 million. These increases were partially offset by a decrease in the use of professional
services of $1.2 million, which is primarily due start-up costs related to the commercialization of
VIVITROL during the three months ended June 30, 2009, that were not incurred during the three
months ended June 30, 2010.
Other Expense, Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Interest income |
$ |
|
0.8 |
|
$ |
|
1.6 |
|
$ |
|
(0.8 |
) |
Interest expense |
|
|
(1.1 |
) |
|
|
(1.7 |
) |
|
|
0.6 |
|
Other expense, net |
|
|
(0.1 |
) |
|
|
(0.1 |
) |
|
|
- |
|
|
|
|
|
|
|
|
Total other expense, net |
$ |
|
(0.4 |
) |
$ |
|
(0.2 |
) |
$ |
|
(0.2 |
) |
|
|
|
|
|
|
|
The decrease in interest income for the three months ended June 30, 2010, as compared to the
three months ended June 30, 2009, was due to a lower average balance of cash and investments as
well as lower interest rates earned. The decrease in interest expense for the three months ended
June 30, 2010, as compared to the three months ended June 30, 2009, was the result of a lower
outstanding principal balance on our non-recourse 7% Notes as we
began making scheduled quarterly principal payments on April 1, 2009. On July 1, 2010, we
redeemed the non-recourse 7% Notes in full and, as a result, we will
incur approximately $0.8 million in additional interest expense in
the three months ended September 30, 2010 primarily related to the
premium paid on the redemption of the non-recourse 7% Notes.
23
expense related to the non-recourse 7% Notes during the remainder of
fiscal year 2011.
Income Tax Benefit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change |
|
|
June 30, |
|
Favorable/ |
(In millions) |
|
2010 |
|
2009 |
|
(Unfavorable) |
Income tax benefit |
$ |
|
(0.1 |
) |
$ |
|
(0.1 |
) |
$ |
|
- |
|
|
|
|
|
|
|
|
We recorded an income tax benefit of $0.1 million for the three months ended June 30, 2010,
primarily related to our recognition of $0.3 million of income tax expense recorded as a discrete
item within other comprehensive loss associated with the increase in the value of certain
securities that we carried at fair market value. The income tax benefit of $0.1 million for the
three months ended June 30, 2009 represented the amount we estimated we would benefit from the
Housing and Economic Recovery Act of 2008.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
March 31, |
(In millions) |
|
2010 |
|
2010 |
Cash and cash equivalents |
$ |
|
90.0 |
|
$ |
|
79.3 |
|
Investments short-term |
|
|
202.2 |
|
|
|
202.1 |
|
Investments long-term |
|
|
36.3 |
|
|
|
68.8 |
|
|
|
|
|
|
Total cash, cash equivalents and investments |
$ |
|
328.5 |
|
$ |
|
350.2 |
|
|
|
|
|
|
Working capital |
$ |
|
271.5 |
|
$ |
|
247.1 |
|
Outstanding borrowings current and long-term |
$ |
|
44.8 |
|
$ |
|
51.0 |
|
Our cash flows for the three months ended June 30, 2010 and 2009 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
June 30, |
(In millions) |
|
2010 |
|
2009 |
Cash and cash equivalents, beginning of period |
$ |
|
79.3 |
|
$ |
|
86.9 |
|
Cash (used in) operating activities |
|
|
(13.0 |
) |
|
|
(15.6 |
) |
Cash provided by (used in) investing activities |
|
|
29.0 |
|
|
|
(18.0 |
) |
Cash (used in) financing activities |
|
|
(5.3 |
) |
|
|
(8.4 |
) |
|
|
|
|
|
Cash and cash equivalents, end of period |
$ |
|
90.0 |
|
$ |
|
44.9 |
|
|
|
|
|
|
Our primary sources of liquidity are cash provided by operating activities, payments received
under R&D arrangements and other arrangements with collaborators, private placements of debt
securities and equipment financing arrangements. The decrease in cash used in operating activities
during the three months ended June 30, 2010, as compared to the three months ended June 30, 2009,
is primarily due to $2.4 million more in cash collected from our customers during the three months
ended June 30, 2010. The increase in cash flows provided by investing activities during the three
months ended June 30, 2010, as compared to the three months ended June 30, 2009, is primarily due
to the net conversion of $33.1 million of our investments to cash during the three months ended
June 30, 2010, as compared to a net investment of $15.9 million of our cash during the three months
ended June 30, 2009. The decrease in cash flows used in financing activities during the three
months ended June 30, 2010, as compared to the three months ended June 30, 2009, is primarily due
to the purchase of $2.5 million of treasury stock during the three months ended June 30, 2009.
During the three months ended June 30, 2010, we did not make any purchases of treasury stock.
24
Our investments at June 30, 2010 consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
Gross Unrealized |
|
Estimated |
(in millions) |
|
Cost |
|
Gains |
|
Losses |
|
Fair Value |
Investments short-term |
$ |
|
201.6 |
|
$ |
|
0.6 |
|
$ |
|
- |
|
$ |
|
202.2 |
|
Investments long-term available-for-sale |
|
|
31.7 |
|
|
|
0.5 |
|
|
|
(1.8 |
) |
|
|
30.4 |
|
Investments long-term held-to-maturity |
|
|
5.9 |
|
|
|
- |
|
|
|
- |
|
|
|
5.9 |
|
|
|
|
|
|
|
|
|
|
Total |
$ |
|
239.2 |
|
$ |
|
1.1 |
|
$ |
|
(1.8 |
) |
$ |
|
238.5 |
|
|
|
|
|
|
|
|
|
|
Our investment objectives are, first, to preserve liquidity and conserve capital and, second,
to generate investment income. We mitigate credit risk in our cash reserves by maintaining a well
diversified portfolio that limits the amount of investment exposure as to institution, maturity and
investment type. However, the value of these securities may be adversely affected by the
instability of the global financial markets which could, in turn, adversely impact our financial
position and our overall liquidity. Our available-for-sale investments consist primarily of short
and long-term U.S. government and agency debt securities, debt securities issued by foreign
agencies and backed by foreign governments and corporate debt securities. Our held-to-maturity
investments consist of investments that are restricted and held as collateral under certain letters
of credit related to certain of our lease agreements.
We classify available-for-sale investments in an unrealized loss position, which do not mature
within 12 months, as long-term investments. We have the intent and ability to hold these
investments until recovery, which may be at maturity, and it is more likely than not that we would
not be required to sell these securities before recovery of their amortized cost. At June 30, 2010,
we performed an analysis of our investments with unrealized losses for impairment and determined
that they are temporarily impaired.
At June 30, 2010 and March 31, 2010, 3% and 4%, respectively, of our investments are valued
using unobservable, or Level 3, inputs to determine fair value as they are not actively trading and
fair values could not be derived from quoted market prices. These investments consist primarily of
a student loan backed auction rate security. During the three months ended June 30, 2010, $5.5
million of our Level 3 investments were redeemed at par by the issuers.
Borrowings
At June 30, 2010, our borrowings consisted of $44.9 million principal amount of the
non-recourse 7% Notes, which had a carrying value of $44.7 million. On July 1, 2010, in addition to
a scheduled principal payment of $6.4 million, we redeemed the non-recourse 7% Notes in full in
exchange for $39.2 million, which was 101.75% of the outstanding principal balance in accordance
with the provisions of the purchase and sales agreement. We expect to save $3.2 million in interest
and accretion expense through the scheduled maturity date as a result of redeeming these notes on
July 1, 2010.
Contractual Obligations
Refer to Part II, Item 7 of our Annual Report on Form 10-K for the year ended March 31, 2010
in the Contractual Obligations section for a discussion of our contractual obligations. Our
contractual obligations as of June 30, 2010 were not materially changed from the date of that
report. As noted in the Borrowings section above, we redeemed the non-recourse 7% Notes in full
on July 1, 2010.
Off-Balance Sheet Arrangements
At June 30, 2010, we were not a party to any off-balance sheet arrangements that have, or are
reasonably likely to have, a current or future effect on our financial condition, changes in
financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or
capital resources material to investors.
Critical Accounting Estimates
The discussion and analysis of our financial condition and results of operations is based on
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United
25
States of America (GAAP). The preparation of these financial
statements requires us to make estimates and assumptions that affect the reported amounts of assets
and liabilities and the disclosure of contingent assets and liabilities at the date of our
financial statements and the reported amounts of revenues and expenses during the reporting period.
Actual results may differ from these estimates under different assumptions or conditions. Refer to
Part II, Item 7 of our Annual Report on Form 10-K for the year ended March 31, 2010 in the
Critical Accounting Estimates section for a discussion of our critical accounting estimates.
New Accounting Standards
Refer to New Accounting Pronouncements included in Note 1, Summary of Significant Accounting
Policies in the accompanying Notes to Condensed Consolidated Financial Statements for a discussion
of new accounting standards.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our market risks, and the ways we manage them, are summarized in Part II, Item 7A,
Quantitative and Qualitative Disclosures About Market Risk of our Annual Report on Form 10-K for
the year ended March 31, 2010. We regularly review our marketable securities holdings and shift our
investment holdings to those that best meet our investment objectives, which are, first, to
preserve liquidity and conserve capital and, second, to generate investment income. Apart from such
adjustments to our investment portfolio, there have been no material changes to our market risks in
the first three months of fiscal year 2011, and we do not anticipate any near-term changes in the
nature of our market risk exposures or in our managements objectives and strategies with respect
to managing such exposures.
We are exposed to foreign currency exchange risk related to manufacturing and royalty revenues
that we receive on RISPERDAL CONSTA as summarized in Part II, Item 7A, Quantitative and
Qualitative Disclosures About Market Risk of our Annual Report on Form 10-K for the year ended
March 31, 2010. There has been no material change in our assessment of our sensitivity to foreign
currency exchange rate risk during the first three months of fiscal year 2011.
Item 4. Controls and Procedures
a) Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial
Officer, evaluated the effectiveness of the design and operation of our disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended,
(the Exchange Act) at June 30, 2010. Based on that evaluation, our Chief Executive Officer and
Chief Financial Officer concluded that our disclosure controls and procedures were effective as of
June 30, 2010 to provide reasonable assurance that the information required to be disclosed by us
in the reports that we file under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the Securities and Exchange Commissions (SEC) rules and
forms and that such information is accumulated and communicated to our management, including our
Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
regarding required disclosure. In designing and evaluating our disclosure controls and procedures,
our management recognized that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control objectives, and
our management necessarily was required to apply its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
b) Change in Internal Control over Financial Reporting
During the period covered by this report, there have been no changes in our internal control
over financial reporting that have materially affected, or are reasonably likely to materially
affect, our internal control over
financial reporting.
26
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be subject to legal proceedings and claims in the ordinary course of
business. We are not aware of any such proceedings or claims that we believe will have,
individually or in the aggregate, a material adverse effect on our business, results of operations
and financial condition.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On November 21, 2007, our board of directors authorized a program to repurchase up to $175.0
million of our common stock to be repurchased at the discretion of management from time to time in
the open market or through privately negotiated transactions. On June 16, 2008, the board of
directors authorized the expansion of this program to $215.0 million. We did not purchase any
shares under this program during the quarter ended June 30, 2010. As of June 30, 2010, we have
purchased a total of 8,866,342 shares under this program at a cost of $114.0 million.
During the three months ended June 30, 2010, we acquired, by means of net share settlements,
96,448 shares of Alkermes common stock at an average price of $11.38 per share related to the
vesting of employee stock awards to satisfy employee withholding tax obligations.
Item 5. Other Information
The Companys policy governing transactions in its securities by its directors, officers and
employees permits its officers, directors and employees to enter into trading plans in accordance
with Rule 10b5-1 under the Exchange Act. During the quarter ended June 30, 2010, Mr. Richard F.
Pops, a director and executive officer of the Company, and Ms. Kathryn L. Biberstein, Dr. Elliot
Ehrich, and Mr. Michael J. Landine, each an executive officer of the Company, entered into trading
plans in accordance with Rule 10b5-1, and the Companys policy governing transactions in its
securities by its directors, officers and employees. The Company undertakes no obligation to update
or revise the information provided herein, including for revision or termination of an established
trading plan.
Item 6. Exhibits
(a) List of Exhibits:
|
|
|
Exhibit |
|
|
No. |
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a)
Certification (filed herewith). |
31.2
|
|
Rule 13a-14(a)/15d-14(a)
Certification (filed herewith). |
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(furnished herewith). |
101
|
|
The following materials from
Alkermes, Inc.s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2010, formatted in XBRL (Extensible Business Reporting
Language): (i) the Condensed Consolidated Balance Sheets, (ii) the
Condensed Consolidated Statements of Operations, (iii) the Condensed
Consolidated Statements of Cash Flows, and (iv) the Notes
to the Condensed Consolidated Financial Statements, tagged as blocks
of text (furnished herewith). |
27
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
ALKERMES, INC.
(Registrant)
|
|
|
By: |
/s/ Richard F. Pops
|
|
|
|
Chairman, President and Chief Executive Officer |
|
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ James M. Frates
|
|
|
|
Senior Vice President, Chief Financial Officer and Treasurer |
|
|
|
(Principal Financial and Accounting Officer) |
|
|
Date: August 6, 2010
28
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No |
|
|
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification (filed herewith). |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification (filed herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(furnished herewith). |
|
|
|
101
|
|
The following materials from
Alkermes, Inc.s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2010, formatted in XBRL (Extensible Business Reporting
Language): (i) the Condensed Consolidated Balance Sheets, (ii) the
Condensed Consolidated Statements of Operations, (iii) the Condensed
Consolidated Statements of Cash Flows, and (iv) the Notes
to the Condensed Consolidated Financial Statements, tagged as blocks
of text (furnished herewith). |