e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2008
|
|
|
o |
|
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)
|
|
|
PENNSYLVANIA
|
|
23-2472830 |
(State or other jurisdiction of
|
|
(I.R.S. Employer |
incorporation or organization)
|
|
Identification No.) |
|
|
|
88 Sidney Street, Cambridge, MA
|
|
02139-4234 |
(Address of principal executive offices)
|
|
(Zip Code) |
Registrants telephone number including area code:
(617) 494-0171
(Former name, former address, and former fiscal year, if changed since last report)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
|
|
|
|
|
|
|
Large accelerated filer
þ |
|
Accelerated filer o |
|
Non-accelerated filer o
(Do not check if a smaller reporting company) |
|
Smaller reporting company o |
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:
|
|
|
|
|
|
|
As of |
Class |
|
November 5, 2008 |
Common Stock, $.01 par value |
|
|
94,932,052 |
|
Non-Voting Common Stock, $.01 par value |
|
|
382,632 |
|
ALKERMES, INC. AND SUBSIDIARIES
INDEX
2
PART 1. FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements:
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
|
|
2008 |
|
|
2008 |
|
|
|
(In thousands, except share |
|
|
|
and per share amounts) |
|
ASSETS |
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
68,525 |
|
|
$ |
101,241 |
|
Investments short-term |
|
|
263,913 |
|
|
|
240,064 |
|
Receivables |
|
|
36,047 |
|
|
|
47,249 |
|
Inventory |
|
|
15,721 |
|
|
|
18,884 |
|
Prepaid expenses and other current assets |
|
|
15,354 |
|
|
|
5,720 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
399,560 |
|
|
|
413,158 |
|
|
|
|
|
|
|
|
PROPERTY, PLANT AND EQUIPMENT: |
|
|
|
|
|
|
|
|
Land |
|
|
301 |
|
|
|
301 |
|
Building and improvements |
|
|
36,371 |
|
|
|
35,003 |
|
Furniture, fixtures and equipment |
|
|
65,293 |
|
|
|
63,364 |
|
Equipment under capital lease |
|
|
464 |
|
|
|
464 |
|
Leasehold improvements |
|
|
33,614 |
|
|
|
33,387 |
|
Construction in progress |
|
|
40,686 |
|
|
|
42,859 |
|
|
|
|
|
|
|
|
|
|
|
176,729 |
|
|
|
175,378 |
|
Less: accumulated depreciation |
|
|
( 67,922 |
) |
|
|
( 62,839 |
) |
|
|
|
|
|
|
|
Total property, plant and equipment net |
|
|
108,807 |
|
|
|
112,539 |
|
|
|
|
|
|
|
|
INVESTMENTS LONG-TERM |
|
|
93,395 |
|
|
|
119,056 |
|
OTHER ASSETS |
|
|
3,256 |
|
|
|
11,558 |
|
|
|
|
|
|
|
|
TOTAL ASSETS |
|
$ |
605,018 |
|
|
$ |
656,311 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
23,623 |
|
|
$ |
36,046 |
|
Unearned milestone revenue current portion |
|
|
5,728 |
|
|
|
5,927 |
|
Deferred revenue current portion |
|
|
298 |
|
|
|
|
|
Long-term debt current portion |
|
|
|
|
|
|
47 |
|
Non-recourse RISPERDAL CONSTA secured 7% notes current portion |
|
|
15,835 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
45,484 |
|
|
|
42,020 |
|
|
|
|
|
|
|
|
NON-RECOURSE RISPERDAL CONSTA SECURED 7% NOTES |
|
|
76,054 |
|
|
|
160,324 |
|
UNEARNED MILESTONE REVENUE LONG-TERM PORTION |
|
|
108,890 |
|
|
|
111,730 |
|
DEFERRED REVENUE LONG-TERM PORTION |
|
|
28,397 |
|
|
|
27,837 |
|
OTHER LONG-TERM LIABILITIES |
|
|
7,228 |
|
|
|
9,086 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES |
|
|
266,053 |
|
|
|
350,997 |
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES (Note 12)
|
|
|
|
|
|
|
|
|
SHAREHOLDERS EQUITY: |
|
|
|
|
|
|
|
|
Capital stock, par value, $0.01 per share; 4,550,000 shares
authorized (includes 3,000,000 shares of preferred stock); none
issued and outstanding |
|
|
|
|
|
|
|
|
Common stock, par value, $0.01 per share; 160,000,000 shares
authorized; 103,912,534 and 102,977,348 shares issued;
94,912,489 and 95,099,166 shares outstanding at September 30,
2008 and March 31, 2008, respectively |
|
|
1,039 |
|
|
|
1,030 |
|
Non-voting common stock, par value, $0.01 per share;
450,000 shares authorized; 382,632 shares issued and
outstanding at September 30, 2008 and March 31, 2008 |
|
|
4 |
|
|
|
4 |
|
Treasury stock, at cost (9,000,045 and 7,878,182 shares at
September 30, 2008 and March 31, 2008, respectively) |
|
|
( 120,970 |
) |
|
|
( 107,322 |
) |
Additional paid-in capital |
|
|
885,259 |
|
|
|
869,695 |
|
Accumulated other comprehensive loss |
|
|
( 1,185 |
) |
|
|
( 1,526 |
) |
Accumulated deficit |
|
|
( 425,182 |
) |
|
|
( 456,567 |
) |
|
|
|
|
|
|
|
TOTAL SHAREHOLDERS EQUITY |
|
|
338,965 |
|
|
|
305,314 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
|
$ |
605,018 |
|
|
$ |
656,311 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ALKERMES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands, except per share amounts) |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing revenues |
|
$ |
33,039 |
|
|
$ |
24,137 |
|
|
$ |
71,649 |
|
|
$ |
55,654 |
|
Royalty revenues |
|
|
8,439 |
|
|
|
7,348 |
|
|
|
17,020 |
|
|
|
14,330 |
|
Research and development revenue
under collaborative arrangements |
|
|
5,252 |
|
|
|
21,206 |
|
|
|
36,702 |
|
|
|
44,656 |
|
Net collaborative profit |
|
|
581 |
|
|
|
5,909 |
|
|
|
1,932 |
|
|
|
12,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
47,311 |
|
|
|
58,600 |
|
|
|
127,303 |
|
|
|
127,538 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods manufactured |
|
|
12,071 |
|
|
|
9,218 |
|
|
|
26,385 |
|
|
|
19,363 |
|
Research and development |
|
|
19,710 |
|
|
|
28,317 |
|
|
|
41,971 |
|
|
|
60,936 |
|
Selling, general and administrative |
|
|
11,679 |
|
|
|
14,487 |
|
|
|
23,605 |
|
|
|
29,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
43,460 |
|
|
|
52,022 |
|
|
|
91,961 |
|
|
|
110,186 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING INCOME |
|
|
3,851 |
|
|
|
6,578 |
|
|
|
35,342 |
|
|
|
17,352 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER (EXPENSE) INCOME: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2,693 |
|
|
|
4,246 |
|
|
|
6,309 |
|
|
|
8,648 |
|
Interest expense |
|
|
(4,243 |
) |
|
|
(4,077 |
) |
|
|
(8,469 |
) |
|
|
(8,150 |
) |
Other (expense) income |
|
|
(666 |
) |
|
|
1,151 |
|
|
|
(830 |
) |
|
|
1,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (expense) income |
|
|
(2,216 |
) |
|
|
1,320 |
|
|
|
(2,990 |
) |
|
|
1,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INCOME BEFORE INCOME TAXES |
|
|
1,635 |
|
|
|
7,898 |
|
|
|
32,352 |
|
|
|
19,027 |
|
INCOME TAX (BENEFIT) PROVISION |
|
|
(63 |
) |
|
|
200 |
|
|
|
967 |
|
|
|
2,582 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET INCOME |
|
$ |
1,698 |
|
|
$ |
7,698 |
|
|
$ |
31,385 |
|
|
$ |
16,445 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EARNINGS PER COMMON SHARE: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC |
|
$ |
0.02 |
|
|
$ |
0.08 |
|
|
$ |
0.33 |
|
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
$ |
0.02 |
|
|
$ |
0.07 |
|
|
$ |
0.32 |
|
|
$ |
0.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE NUMBER OF COMMON
SHARES OUTSTANDING: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC |
|
|
95,637 |
|
|
|
101,595 |
|
|
|
95,211 |
|
|
|
101,663 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
97,356 |
|
|
|
104,315 |
|
|
|
96,729 |
|
|
|
104,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(In thousands) |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
31,385 |
|
|
$ |
16,445 |
|
Adjustments to reconcile net income to cash flows from operating activities: |
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
8,309 |
|
|
|
10,295 |
|
Depreciation |
|
|
4,901 |
|
|
|
6,114 |
|
Other non-cash charges |
|
|
2,564 |
|
|
|
2,187 |
|
Loss on the purchase of the 7% Notes |
|
|
1,989 |
|
|
|
|
|
Change in fair value of warrants |
|
|
|
|
|
|
(1,426 |
) |
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Receivables |
|
|
2,251 |
|
|
|
10,939 |
|
Inventory, prepaid expenses and other assets |
|
|
890 |
|
|
|
(8,116 |
) |
Accounts payable and accrued expenses |
|
|
(10,785 |
) |
|
|
(20,707 |
) |
Unearned milestone revenue |
|
|
(3,039 |
) |
|
|
(8,101 |
) |
Deferred revenue |
|
|
2,092 |
|
|
|
2,086 |
|
Other liabilities |
|
|
(1,363 |
) |
|
|
(155 |
) |
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
39,194 |
|
|
|
9,561 |
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment |
|
|
(3,567 |
) |
|
|
(14,609 |
) |
Sales of property, plant and equipment |
|
|
7,717 |
|
|
|
|
|
Purchases of investments |
|
|
(462,412 |
) |
|
|
(291,480 |
) |
Sales and maturities of investments |
|
|
463,959 |
|
|
|
293,861 |
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
5,697 |
|
|
|
(12,228 |
) |
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
7,221 |
|
|
|
9,122 |
|
Excess tax benefit from stock options |
|
|
74 |
|
|
|
108 |
|
Payment of debt |
|
|
(47 |
) |
|
|
(644 |
) |
Purchase of non-recourse RISPERDAL CONSTA secured 7% notes |
|
|
(71,775 |
) |
|
|
|
|
Purchase of treasury stock |
|
|
(13,080 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
(77,607 |
) |
|
|
8,586 |
|
|
|
|
|
|
|
|
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
(32,716 |
) |
|
|
5,919 |
|
CASH AND CASH EQUIVALENTS Beginning of period |
|
|
101,241 |
|
|
|
80,500 |
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS End of period |
|
$ |
68,525 |
|
|
$ |
86,419 |
|
|
|
|
|
|
|
|
SUPPLEMENTAL CASH FLOW DISCLOSURE: |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
6,662 |
|
|
$ |
5,999 |
|
Cash paid for income taxes |
|
$ |
435 |
|
|
$ |
980 |
|
Non-cash investing and financing activities: |
|
|
|
|
|
|
|
|
Purchased capital expenditures included in accounts payable and accrued expenses |
|
$ |
233 |
|
|
$ |
246 |
|
Net share exercise of warrants into common stock of the issuer |
|
$ |
|
|
|
$ |
2,994 |
|
Receipt of Alkermes shares for the purchase of stock options or as payment to
satisfy minimum withholding tax obligations related to stock based awards |
|
$ |
568 |
|
|
$ |
924 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying condensed consolidated financial statements of Alkermes, Inc. (the Company
or Alkermes) for the three and six months ended September 30, 2008 and 2007 are unaudited and
have been prepared on a basis substantially consistent with the audited financial statements for
the year ended March 31, 2008. The year-end condensed consolidated balance sheet data was derived
from audited financial statements, but does not include all disclosures required by accounting
principles generally accepted in the United States of America (commonly referred to as GAAP). In
the opinion of management, the condensed consolidated financial statements include all adjustments,
which are of a normal recurring nature, that are necessary to present fairly the results of
operations for the reported periods.
These financial statements should be read in conjunction with the Companys audited
consolidated financial statements and notes thereto which are contained in the Companys Annual
Report on Form 10-K for the year ended March 31, 2008, as filed with the Securities and Exchange
Commission (SEC).
The results of the Companys operations for any interim period are not necessarily indicative
of the results of the Companys operations for any other interim period or for a full fiscal year.
Principles of Consolidation The condensed consolidated financial statements include the
accounts of Alkermes, Inc. and its wholly-owned subsidiaries: Alkermes Controlled Therapeutics,
Inc.; Alkermes Europe, Ltd. and RC Royalty Sub LLC (Royalty Sub). The assets of Royalty Sub are
not available to satisfy obligations of Alkermes and its subsidiaries, other than the obligations
of Royalty Sub, including Royalty Subs non-recourse RISPERDAL® CONSTA®
secured 7% notes (the 7% Notes). Intercompany accounts and transactions have been eliminated.
Use of Estimates The preparation of the Companys condensed consolidated financial
statements in conformity with GAAP necessarily requires management to make estimates and
assumptions that affect the following: (1) reported amounts of assets and liabilities;
(2) disclosure of contingent assets and liabilities at the date of the condensed consolidated
financial statements; and (3) the reported amounts of revenues and expenses during the reporting
period. Actual results could differ from these estimates.
New Accounting Pronouncements
In November 2007, the Emerging Issues Task Force (EITF) of the Financial Accounting
Standards Board (FASB) reached a final consensus on EITF Issue No. 07-1, Accounting for
Collaborative Arrangements Related to the Development and Commercialization of Intellectual
Property (EITF No. 07-1). EITF No. 07-1 is effective for the Companys fiscal year beginning
April 1, 2009. Adoption is on a retrospective basis to all prior periods presented for all
collaborative arrangements existing as of the effective date. The Company is currently evaluating
the impact of the adoption of EITF No. 07-1 on its consolidated financial statements.
In March 2008, the FASB issued Statement of Financial Accounting Standards (SFAS) No. 161,
Disclosures about Derivative Instruments and Hedging Activities (SFAS No. 161). SFAS No. 161 is
intended to improve financial reporting about derivative instruments and hedging activities by
requiring enhanced disclosures to enable investors to better understand their effects on an
entitys financial position, financial performance and cash flows. SFAS No. 161 is effective for
the Companys fiscal year beginning April 1, 2009, and the Company does not expect the adoption of
this standard to have a material impact on its consolidated financial statements.
6
ALKERMES, INC. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. COMPREHENSIVE INCOME
Comprehensive income for the three and six months ended September 30, 2008 and 2007 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net income |
|
$ |
1,698 |
|
|
$ |
7,698 |
|
|
$ |
31,385 |
|
|
$ |
16,445 |
|
Unrealized gains
(losses) on
available-for-sale
securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Holding losses |
|
|
(61 |
) |
|
|
(25 |
) |
|
|
(266 |
) |
|
|
(550 |
) |
Reclassification of
unrealized losses
to realized losses
on
available-for-sale
securities |
|
|
559 |
|
|
|
|
|
|
|
607 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains
(losses) on
available-for-sale
securities |
|
|
498 |
|
|
|
(25 |
) |
|
|
341 |
|
|
|
(550 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
2,196 |
|
|
$ |
7,673 |
|
|
$ |
31,726 |
|
|
$ |
15,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. EARNINGS PER COMMON SHARE
Basic earnings per common share is calculated based upon net income available to holders of
common shares divided by the weighted average number of shares outstanding. For the calculation of
diluted earnings per common share, the Company uses the weighted average number of common shares
outstanding, as adjusted for the effect of potential outstanding shares, including stock options
and stock awards.
Basic and diluted earnings per common share are calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
1,698 |
|
|
$ |
7,698 |
|
|
$ |
31,385 |
|
|
$ |
16,445 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding |
|
|
95,637 |
|
|
|
101,595 |
|
|
|
95,211 |
|
|
|
101,663 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
1,479 |
|
|
|
2,371 |
|
|
|
1,329 |
|
|
|
2,451 |
|
Restricted stock awards |
|
|
240 |
|
|
|
349 |
|
|
|
189 |
|
|
|
332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive common share equivalents |
|
|
1,719 |
|
|
|
2,720 |
|
|
|
1,518 |
|
|
|
2,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted
earnings per common share |
|
|
97,356 |
|
|
|
104,315 |
|
|
|
96,729 |
|
|
|
104,446 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options of 13.4 million and 10.3 million for the three months ended September 30, 2008
and 2007, respectively, and 13.9 million and 11.8 million for the six months ended September 30,
2008 and 2007, respectively, were not included in the calculation of net income per common share
because their effects are anti-dilutive. There were 0.1 million and no restricted stock units
excluded from the calculation of net income per common share for the three and months ended
September 30, 2008 and 2007, respectively, and none for the six months ended September 30, 2008 and
2007 because their effects are anti-dilutive.
4. INVESTMENTS
At September 30, 2008 and March 31, 2008, the Company held investments of $352.6 million and
$354.5 million, respectively, of which $88.7 million and $114.4 million are long-term,
respectively, which were classified as available-for-sale and are carried at fair value in the
Companys condensed consolidated balance sheets. These investments include United States
(U.S.) government debt securities, U.S. agency debt securities, municipal debt securities,
investment grade corporate debt securities, including asset backed debt securities, student loan
backed auction rate securities and strategic equity investments.
At September 30, 2008 and March 31, 2008, the Company held investments of $4.7 million, which
were classified as long-term, held-to-maturity securities and were carried at amortized cost. These
investments include
7
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. government debt securities and corporate debt securities that are restricted and held as
collateral under certain letters of credit related to certain of the Companys lease agreements.
At September 30, 2008, the Company had gross unrealized gains of $2.3 million and gross
unrealized losses of $3.5 million on its available-for-sale investments. The Company believes that
the gross unrealized losses on these investments are temporary, and the Company has the intent and
ability to hold these securities to recovery, which may be at maturity. For the six months ended
September 30, 2008, the Company recognized $0.6 million in charges for other-than-temporary losses
on its strategic equity investments.
At September 30, 2008, the Company had $10.0 million in investments in auction rate securities
with an unrealized loss of $0.7 million. The securities represent the Companys investment in
taxable student loan revenue bonds issued by state higher education authorities which service
student loans under the Federal Family Education Loan Program. The bonds were triple A rated at the
date of purchase and are collateralized by student loans purchased by the authorities, which are
guaranteed by state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity
for these securities is typically provided by an auction process that resets the applicable
interest rate at pre-determined intervals. Each of these securities had been subject to auction
processes for which there had been insufficient bidders on the scheduled auction dates and the
auctions subsequently failed. The Company is not able to liquidate its investments in auction rate
securities until future auctions are successful, a buyer is found outside of the auction process or
the bonds are redeemed by the issuer. The securities continue to pay interest at predetermined
interest rates during the periods in which the auctions have failed. At September 30, 2008, the
Company determined that the securities were temporarily impaired due to the length of time each
security was in an unrealized loss position, the extent to which fair value was less than cost, the
financial condition and near term prospects of the issuers and the guarantee agencies, and the
Companys intent and ability to hold each security for a period of time sufficient to allow for any
anticipated recovery in fair value.
At September 30, 2008, the Company had $8.2 million in investments in asset backed debt
securities with an unrealized loss of $0.9 million. The securities represent the Companys
investment in investment grade medium term floating rate notes (MTN) of Aleutian Investments, LLC
(Aleutian) and Meridian Funding Company, LLC (Meridian), which are qualified special purpose
entities (QSPEs) of Ambac Financial Group, Inc. (Ambac) and MBIA, Inc. (MBIA), respectively.
Ambac and MBIA are guarantors of financial obligations and are referred to as monoline financial
guarantee insurance companies. The QSPEs, which purchase pools of assets or securities and fund
the purchase through the issuance of MTNs, have been established to provide a vehicle to access
the capital markets for asset backed debt securities and corporate borrowers. The MTNs include
sinking fund redemption features which match-fund the terms of redemptions to the maturity dates of
the underlying pools of assets or securities in order to mitigate potential liquidity risk to the
QSPEs. At September 30, 2008, a substantial portion of the Companys initial investment in the
Meridian MTNs had been redeemed by MBIA though scheduled sinking fund redemptions at par value,
and the first sinking fund redemption on the Aleutian MTN is scheduled for June 2009.
The liquidity and fair value of these securities has been negatively impacted by the
uncertainty in the credit markets, and the exposure of these securities to the financial condition
of monoline financial guarantee insurance companies, including Ambac and MBIA. In June 2008, Ambac
had its triple A rating reduced to Aa3 by Moodys and double A by Standard and Poors (S&P), and
MBIA was downgraded from triple A to A2 by Moodys and double A by S&P. Both downgrades were due to
Ambacs and MBIAs inability to maintain triple A capital levels. In August 2008, S&P affirmed its
double A ratings of Ambac and MBIA with negative outlook. In September 2008, Moodys placed Ambac
and MBIA on review for possible downgrade. In November 2008, Moodys announced that it had downgraded Ambacs rating to Baa1 with a
developing outlook.
The Company may not be able to liquidate its investment in these securities before the
scheduled redemptions or until trading in the securities resumes in the credit markets, which may
not occur. At September 30, 2008, the Company determined that the securities had been temporarily
impaired due to the length of time each security was in an unrealized loss position, the extent to
which fair value was less than cost, the financial condition and near term prospects of the
issuers, current redemptions made by one of the issuers and the Companys intent and ability to
hold each security for a period of time sufficient to allow for any anticipated recovery in fair
value or until scheduled redemption.
The Company also has warrants to purchase securities of certain publicly held companies
included in its portfolio of strategic equity investments. These warrants are considered to be
derivative instruments and at September 30, 2008 and March 31, 2008, the warrants had carrying
values of less than $0.1 million.
8
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. FAIR VALUE MEASUREMENTS
Effective April 1, 2008, the Company implemented SFAS No. 157, Fair Value Measurements
(SFAS No. 157) for its financial assets and liabilities that are re-measured and reported at fair
value at each reporting period. The adoption of SFAS No. 157 did not have a material impact on the
Companys financial position and results of operations. In accordance with the provisions of FASB
Staff Position FAS 157-2, Effective Date of FASB Statement No. 157 (FSP FAS 157-2) the Company
has elected to defer implementation of SFAS No. 157 as it relates to non-financial assets and
non-financial liabilities that are recognized and disclosed at fair value in the financial
statements on a nonrecurring basis until April 1, 2009. The Company is evaluating the impact, if
any, this standard will have on its non-financial assets and liabilities.
SFAS No. 157 provides a framework for measuring fair value and requires expanded disclosures
regarding fair value measurements. SFAS No. 157 defines fair value as the price that would be
received to sell an asset or paid to transfer a liability (the exit price) in an orderly
transaction between market participants at the measurement date. In determining fair value,
SFAS No. 157 permits the use of various valuation approaches, including market, income and cost
approaches. SFAS No. 157 establishes a hierarchy for inputs used in measuring fair value that
maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available. In October 2008, the FASB issued FASB Staff
Position FAS 157-3 Determining the Fair Value of a Financial Asset When the Market for that Asset
is not Active (FSP FAS 157-3). FSP FAS 157-3 clarifies the application of SFAS No. 157 in a
market that is not active and provides an example to illustrate key considerations in determining
the fair value of a financial asset when the market for that financial asset is not active. FSP FAS
157-3 is effective for the Companys condensed consolidated financial statements for the three and
six months ended September 30, 2008. The adoption of this standard did not have a material impact
on the consolidated financial statements.
The fair value hierarchy is broken down into three levels based on the reliability of inputs.
The Company has categorized its cash, cash equivalents and investments within the hierarchy as
follows:
Level 1 These valuations are based on a market approach using quoted prices in active
markets for identical assets. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 1 inputs include investments in money market funds,
U.S. government debt securities, U.S. agency debt securities, municipal debt securities, bank
deposits and exchange-traded equity securities of certain publicly held companies;
Level 2 These valuations are based on a market approach using quoted prices obtained from
brokers or dealers for similar securities or for securities for which we have limited visibility
into their trading volumes. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 2 inputs consist of investments in corporate debt securities;
Level 3 These valuations are based on an income approach using certain inputs that are
unobservable and are significant to the overall fair value measurement. Valuations of these
products require a significant degree of judgment. Assets utilizing Level 3 inputs consist of
investments in auction rate securities and asset backed debt securities that are not currently
trading. In addition, the Company holds warrants in certain publicly held companies that are
classified using Level 3 inputs. The carrying balance of these warrants was immaterial at
September 30, 2008 and March 31, 2008.
9
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table presents information about the Companys assets and liabilities that are
measured at fair value on a recurring basis at September 30, 2008, and indicates the fair value
hierarchy of the valuation techniques the Company utilized to determine such fair value:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
|
Quoted Prices in |
|
|
Observable |
|
|
Unobservable |
|
|
|
September 30, |
|
|
Active Markets |
|
|
Inputs |
|
|
Inputs |
|
(In thousands) |
|
2008 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents |
|
$ |
7,025 |
|
|
$ |
7,025 |
|
|
$ |
|
|
|
$ |
|
|
U.S. government and agency
and municipal debt
securities |
|
|
250,231 |
|
|
|
250,231 |
|
|
|
|
|
|
|
|
|
Corporate debt securities |
|
|
89,107 |
|
|
|
4,240 |
|
|
|
84,867 |
|
|
|
|
|
Asset backed debt securities |
|
|
7,283 |
|
|
|
|
|
|
|
|
|
|
|
7,283 |
|
Auction rate securities |
|
|
9,272 |
|
|
|
|
|
|
|
|
|
|
|
9,272 |
|
Strategic equity investments |
|
|
1,414 |
|
|
|
1,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
364,332 |
|
|
$ |
262,910 |
|
|
$ |
84,867 |
|
|
$ |
16,555 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair values of the Companys cash equivalents and investments in U.S. government and
agency and municipal debt securities, and corporate debt securities are determined through
observable market sources. The Companys strategic equity investments are investments in certain
publicly traded companies whose fair value is readily determinable.
The fair values of the Companys investments in asset backed debt securities and auction rate
securities are determined using certain inputs that are unobservable and significant to the overall
fair value measurement. Typically, auction rate securities trade at their par value due to the
short interest rate reset period and the availability of buyers or sellers of the securities at
recurring auctions. However, since the security auctions have failed and fair value cannot be
derived from quoted prices, the Company used a discounted cash flow model to determine the
estimated fair value of its investments in auction rate securities at September 30, 2008. The
Company also used a discounted cash flow model to determine the estimated fair value of its
investments in asset backed debt securities at September 30, 2008, as the asset backed debt
securities are not actively trading. The assumptions used in the discounted cash flow models used
to determine the estimated fair value of these securities include estimates for interest rates,
timing of cash flows, expected holding periods and risk adjusted discount rates, which include a
provision for default and liquidity risk. The Companys valuation analyses consider, among other
items, assumptions that market participants would use in their estimates of fair value, such as the
collateral underlying the security, the inability to sell the investment in an active market, the
creditworthiness of the issuer and any associated guarantees, the timing of expected future cash
flows, and the expectation of the next time the security will have a successful auction or when
callability features may be exercised by the issuer. These securities were also compared, where
possible, to other observable market data with similar characteristics.
The following table is a rollforward of the fair value of the Companys investments in asset
backed debt securities and auction rate securities whose fair value is determined using Level 3
inputs:
|
|
|
|
|
|
|
Fair Value |
|
(In thousands) |
|
|
|
|
Balance, April 1, 2008 |
|
$ |
18,612 |
|
Total unrealized losses included in earnings |
|
|
|
|
Total unrealized losses included in comprehensive income |
|
|
(468 |
) |
Redemptions |
|
|
(1,589 |
) |
|
|
|
|
Balance, September 30, 2008 |
|
$ |
16,555 |
|
|
|
|
|
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets
and Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159).
SFAS No. 159 permits, but does not require, entities to elect to measure selected financial
instruments and certain other items at fair value. Unrealized gains and losses on items for which
the fair value option has been elected are recognized in earnings at each reporting period. The
Company adopted the provisions of SFAS No. 159 on April 1, 2008 and did not elect to
10
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
measure any new assets or liabilities at their respective fair values and, therefore, the
adoption of SFAS No. 159 did not have an impact on its results of operations and financial
position.
The carrying amounts reflected in the Companys condensed consolidated balance sheets for cash
and cash equivalents, receivables, other current assets, accounts payable and accrued expenses
approximate fair value due to their short-term durations.
6. INVENTORY
Inventory is stated at the lower of cost or market value. Cost is determined using the
first-in, first-out method. Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In thousands) |
|
2008 |
|
|
2008 |
|
Raw materials |
|
$ |
8,338 |
|
|
$ |
8,373 |
|
Work in process |
|
|
2,215 |
|
|
|
3,060 |
|
Finished goods |
|
|
5,168 |
|
|
|
7,451 |
|
|
|
|
|
|
|
|
Total |
|
$ |
15,721 |
|
|
$ |
18,884 |
|
|
|
|
|
|
|
|
7. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts payable and accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In thousands) |
|
2008 |
|
|
2008 |
|
Accounts payable |
|
$ |
5,019 |
|
|
$ |
7,042 |
|
Accrued compensation |
|
|
8,255 |
|
|
|
11,245 |
|
Accrued interest |
|
|
1,750 |
|
|
|
2,975 |
|
Accrued restructuring current portion |
|
|
804 |
|
|
|
4,037 |
|
Accrued other |
|
|
7,795 |
|
|
|
10,747 |
|
|
|
|
|
|
|
|
Total |
|
$ |
23,623 |
|
|
$ |
36,046 |
|
|
|
|
|
|
|
|
8. RESTRUCTURING
In March 2008, the Company announced the decision by Eli Lilly and Company to discontinue the
AIR® Insulin development program. As a result, the Company terminated approximately
150 employees and closed its commercial manufacturing facility in Chelsea, MA (the 2008
Restructuring). In connection with the 2008 Restructuring, the Company recorded net restructuring
charges of $6.9 million in the year ended March 31, 2008. At September 30, 2008, the Company had
paid in cash approximately $3.5 million in connection with the 2008 Restructuring.
Restructuring activity during the six months ended September 30, 2008 for the 2008
Restructuring is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other |
|
|
|
|
|
|
Facility |
|
|
|
|
|
|
Contract |
|
|
|
|
(In thousands) |
|
Closure |
|
|
Severance |
|
|
Losses |
|
|
Total |
|
Balance, April 1, 2008 |
|
$ |
4,930 |
|
|
$ |
2,881 |
|
|
$ |
37 |
|
|
$ |
7,848 |
|
Additions |
|
|
|
|
|
|
78 |
|
|
|
70 |
|
|
|
148 |
|
Payments |
|
|
(490 |
) |
|
|
(2,952 |
) |
|
|
(107 |
) |
|
|
(3,549 |
) |
Other adjustments |
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, September 30, 2008 (1) |
|
$ |
4,539 |
|
|
$ |
7 |
|
|
$ |
|
|
|
$ |
4,546 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The restructuring liability at September 30, 2008 consists of $0.8 million classified as
current and $3.7 million classified as long-term in the accompanying condensed consolidated balance
sheet. |
In June 2004, the Company and its former collaborative partner Genentech, Inc. announced the
decision to discontinue commercialization of NUTROPIN DEPOT® (the 2004 Restructuring).
In connection with the 2004
11
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Restructuring, the Company recorded charges of $11.5 million in the year ended March 31, 2005.
During the six months ended September 30, 2008, the Company paid $0.1 million in facility closure
costs and recorded an adjustment of $0.1 million to reduce the restructuring charges accrued in
connection with the 2004 Restructuring to zero. As of September 30, 2008, the 2004 Restructuring
was complete.
9. SHARE-BASED COMPENSATION
Share-based compensation expense for the three and six months ended September 30, 2008 and
2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Cost of goods manufactured |
|
$ |
428 |
|
|
$ |
334 |
|
|
$ |
857 |
|
|
$ |
960 |
|
Research and development |
|
|
1,282 |
|
|
|
1,785 |
|
|
|
2,870 |
|
|
|
3,636 |
|
Selling, general and administrative |
|
|
2,104 |
|
|
|
2,429 |
|
|
|
4,582 |
|
|
|
5,699 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,814 |
|
|
$ |
4,548 |
|
|
$ |
8,309 |
|
|
$ |
10,295 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2008 and March 31, 2008, $0.5 million and $0.3 million, respectively, of
share-based compensation cost was capitalized and recorded as Inventory in the condensed
consolidated balance sheets.
10. EXTINGUISHMENT OF DEBT
During the six months ended September 30, 2008, the Company purchased, in three privately
negotiated transactions, $75.0 million in original principal amount of its outstanding 7% Notes for
$71.8 million. As a result of the purchases, $95.0 million principal amount of the 7% Notes remains
outstanding at September 30, 2008. The Company recorded a loss on the extinguishment of the notes
of $2.0 million during the six months ended September 30, 2008, which was recorded as interest
expense.
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 September 30, 2008, the Company
determined that it is more likely than not that the deferred tax assets may not be realized and a
full valuation allowance continues to be recorded.
The income tax benefit in the amount of $0.1 million and income tax provision of $1.0 million
for the three and six months ended September 30, 2008, respectively, and the income tax provision
of $0.2 million and $2.6 million for the three and six months ended September 30, 2007,
respectively, related to the U.S. alternative minimum tax (AMT). Included in the $0.1 million
benefit for the three months ended September 30, 2008 is $0.1 million which represents the amount
the Company estimates it will benefit from as a result of the recently enacted Housing and Economic
Recovery Act of 2008. This legislation allows for certain taxpayers to forego bonus
depreciation in lieu of a refundable cash credit based on certain qualified asset purchases. The
utilization of tax loss carryforwards is limited in the calculation of AMT and, as a result, a
federal tax charge was recorded in the three and six months ended September 30, 2008 and 2007. The
AMT liability is available as a credit against future tax obligations upon the full utilization or
expiration of the Companys net operating loss carryforward.
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.
In November 2007, Reliant Pharmaceuticals, Inc. (Reliant) was acquired by GlaxoSmithKline
(GSK). Under the terms of the acquisition, the Company received $166.9 million upon the closing
of the transaction in December 2007 in exchange for the Companys investment in Series C
convertible, redeemable preferred stock of Reliant. The Company is entitled to receive up to an
additional $7.7 million of funds held in escrow subject to the terms of an escrow agreement between
GSK and Reliant. The escrowed funds represent the maximum potential amount of future payments that
may be payable to GSK under the terms of the escrow agreement, which is effective for a
12
ALKERMES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Continued)
period of 15 months following the closing of the transaction. The Company has not recorded a
liability related to the indemnification to GSK as the Company currently believes that it is remote
that any of the escrowed funds will be needed to indemnify GSK for any losses it might incur
related to the representations and warranties made by Reliant in connection with the acquisition.
13. SEGMENT INFORMATION
The Company operates as one business segment, which is the business of developing,
manufacturing and commercializing innovative medicines designed to yield better therapeutic
outcomes and improve the lives of patients with serious disease. The Companys chief decision
maker, the Chief Executive Officer, reviews the Companys operating results on an aggregate basis
and manages the Companys operations as a single operating unit.
13
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Alkermes, Inc. (as used in this section, together with our subsidiaries, us, we, our or
the Company) is a biotechnology company committed to developing innovative medicines to improve
patients lives. We manufacture RISPERDAL® CONSTA® for schizophrenia and
developed and manufacture VIVITROL® for alcohol dependence. Our pipeline includes
extended-release injectable, pulmonary and oral products for the treatment of prevalent, chronic
diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in
Cambridge, Massachusetts, we have research and manufacturing facilities in Massachusetts and Ohio.
We have funded our operations primarily with funds generated by our business operations and
through public offerings and private placements of debt and equity securities, bank loans, term
loans, equipment financing arrangements and payments received under research and development
agreements and other agreements with collaborators. We expect to incur significant additional
research and development and other costs in connection with certain collaborative arrangements and
as we expand the development of our proprietary product candidates, including costs related to
preclinical studies, clinical trials and facilities expansion. Our costs, including research and
development costs for our product candidates and selling, marketing and promotion expenses for any
future products to be marketed by us or our collaborators, if any, may exceed revenues in the
future, which may result in losses from operations.
Forward-Looking Statements
Any statements herein or otherwise made in writing or orally by us with regard to our
expectations as to financial results and other aspects of our business may constitute
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995, including, but not limited to, statements concerning future operating results, the
achievement of certain business and operating goals, manufacturing revenues, research and
development spending, plans for clinical trials and regulatory approvals, spending relating to
selling and marketing and clinical development activities, financial goals and projections of
capital expenditures, recognition of revenues, and future financings. These statements relate to
our future plans, objectives, expectations and intentions and may be identified by words like
believe, expect, designed, may, will, should, seek, or anticipate, and similar
expressions.
Although we believe that our expectations are based on reasonable assumptions within the
bounds of our knowledge of our business and operations, the forward-looking statements contained in
this document are neither promises nor guarantees, and our business is subject to significant risk
and uncertainties and there can be no assurance that our actual results will not differ materially
from our expectations. These forward looking statements include, but are not limited to, statements
concerning: the achievement of certain business and operating milestones and future operating
results and profitability; continued revenue growth from RISPERDAL CONSTA; the commercialization of
VIVITROL in the U.S. by Cephalon and in Russia and countries in the Commonwealth of Independent
States by Cilag GmbH International (Cilag), a subsidiary of Johnson & Johnson; recognition of
milestone payments from our partners related to the future sales of VIVITROL; the successful
continuation of development activities for our programs, including exenatide once weekly; the
successful manufacture of our products and product candidates, including RISPERDAL CONSTA and
VIVITROL at a commercial scale, and the successful manufacture of exenatide once weekly by Amylin
Pharmaceuticals, Inc. (Amylin); and the building of a selling and marketing infrastructure for
VIVITROL. Factors which could cause actual results to differ materially from our expectations set
forth in our forward-looking statements include, among others: (i) manufacturing and royalty
revenues from RISPERDAL CONSTA may not continue to grow, particularly because we rely on our
partner, Janssen Pharmaceutica, Inc., a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and
Janssen Pharmaceutica International, a division of Cilag International (together, Janssen), to
forecast and market this product; (ii) we may be unable to manufacture RISPERDAL CONSTA and
VIVITROL in sufficient quantities and with sufficient yields to meet our partners requirements or
to add additional production capacity for RISPERDAL CONSTA and VIVITROL, or unexpected events could
interrupt manufacturing operations at our RISPERDAL CONSTA and VIVITROL manufacturing facility,
which is the sole source of supply for these products; (iii) we may be unable to develop the
selling and marketing capabilities, and/or infrastructure, necessary to successfully commercialize
VIVITROL; (iv) Cilag may be unable to receive approval for VIVITROL for the treatment of opioid
dependence in Russia and for the treatment of alcohol and opioid dependence in the other countries
in the CIS; (v) Cilag may be unable to successfully commercialize VIVITROL; (vi) third party
payors may not cover or reimburse VIVITROL; (vii) we may be unable to scale-up and manufacture our
product candidates commercially or
14
economically; (viii) we may not be able to source raw materials for our production processes
from third parties; (ix) we may not be able to successfully transfer manufacturing technology and
related systems for exenatide once weekly to Amylin, and Amylin may not be able to successfully
operate the manufacturing facility for exenatide once weekly; (x) our product candidates, if
approved for marketing, may not be launched successfully in one or all indications for which
marketing is approved and, if launched, may not produce significant revenues; (xi) we rely on our
partners to determine the regulatory and marketing strategies for RISPERDAL CONSTA and our other
partnered, non-proprietary programs; (xii) RISPERDAL CONSTA, VIVITROL and our product candidates in
commercial use may have unintended side effects, adverse reactions or incidents of misuse and the
U.S. Food and Drug Administration (FDA) or other health authorities could require post approval
studies or require removal of our products from the market; (xiii) our collaborators could elect to
terminate or delay programs at any time and disputes with collaborators or failure to negotiate
acceptable new collaborative arrangements for our technologies could occur; (xiv) clinical trials
may take more time or consume more resources than initially envisioned; (xv) results of earlier
clinical trials may not necessarily be predictive of the safety and efficacy results in larger
clinical trials; (xvi) our product candidates could be ineffective or unsafe during preclinical
studies and clinical trials, and we and our collaborators may not be permitted by regulatory
authorities to undertake new or additional clinical trials for product candidates incorporating our
technologies, or clinical trials could be delayed or terminated; (xvii) after the completion of
clinical trials for our product candidates and the submission for marketing approval, the FDA or
other health authorities could refuse to accept such filings or could request additional
preclinical or clinical studies be conducted, each of which could result in significant delays or
the failure of such product to receive marketing approval; (xviii) even if our product candidates
appear promising at an early stage of development, product candidates could fail to receive
necessary regulatory approvals, be difficult to manufacture on a large scale, be uneconomical, fail
to achieve market acceptance, be precluded from commercialization by proprietary rights of third
parties or experience substantial competition in the marketplace; (xix) technological change in the
biotechnology or pharmaceutical industries could render our products and/or product candidates
obsolete or non-competitive; (xx) difficulties or set-backs in obtaining and enforcing our patents
and difficulties with the patent rights of others could occur; (xxi) we may incur losses in the
future; (xxvi) we may need to raise substantial additional funding to continue research and
development programs and clinical trials and other operations and could incur difficulties or
setbacks in raising such funds; (xxii) we may not be able to liquidate or otherwise recoup our
investments in our asset backed debt securities and auction rate securities.
The forward-looking statements made in this document are made only as of the date hereof and
we do not intend to update any of these factors or to publicly announce the results of any
revisions to any of our forward-looking statements other than as required under the federal
securities laws.
Our Strategy
We leverage our unique formulation expertise and drug development technologies to develop,
both with partners and on our own, innovative and competitively advantaged drug products that
enhance patient outcomes in major therapeutic areas. We enter into select collaborations with
pharmaceutical and biotechnology companies to develop significant new product candidates, based on
existing drugs and incorporating our technologies. In addition, we develop our own proprietary
therapeutics by applying our innovative formulation expertise and drug development capabilities to
create new pharmaceutical products. Each of these approaches is discussed in more detail below.
15
Product Developments
RISPERDAL CONSTA
RISPERDAL CONSTA is a long-acting formulation of risperidone, a product of Janssen. RISPERDAL
CONSTA is the first and only long-acting, atypical antipsychotic to be approved by the FDA. The
medication uses our proprietary Medisorb® technology to deliver and maintain therapeutic
medication levels in the body through just one injection every two weeks. Schizophrenia is a brain
disorder characterized by disorganized thinking, delusions and hallucinations. Studies have
demonstrated that as many as 75 percent of patients with schizophrenia have difficulty taking their
oral medication on a regular basis, which can lead to worsening of symptoms. Clinical data has
shown that treatment with RISPERDAL CONSTA may lead to improvements in symptoms, sustained
remission and decreases in hospitalization. RISPERDAL CONSTA is marketed by Janssen and is
exclusively manufactured by us. RISPERDAL CONSTA was first approved by regulatory authorities in
the United Kingdom (U.K.) and Germany in August 2002 and the FDA in October 2003. RISPERDAL
CONSTA is approved in approximately 85 countries and marketed in approximately 60 countries, and
Janssen continues to launch the product around the world.
In April 2008, we announced that our partner, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for
RISPERDAL CONSTA to the FDA seeking approval for adjunctive maintenance treatment to delay the
occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD). FRBD
is defined as four or more manic or depressive episodes in the previous year that require a
doctors care. The condition may affect 10 to 20 percent of the 27 million people with bipolar
disorder.
In May 2008, we and Janssen agreed to begin development of a four-week formulation of
RISPERDAL CONSTA, which could offer patients and physicians another dosing option.
In May 2008, the results of a study sponsored by Janssen were presented at the American
Psychiatric Association (APA) 161st Annual Meeting in Washington D.C. This twenty-four month,
open-label, active-controlled, international study investigated whether treatment with Risperidone
Long-Acting Injection (RLAI), compared with oral quetiapine when tested in a routine care setting
within general psychiatric services, had an effect on long-term efficacy maintenance as measured by
time to relapse in patients with schizophrenia. The results demonstrated that the average
relapse-free time was significantly longer in patients treated with RLAI (607 days) compared to
quetiapine (533 days) (p<0.0001). Furthermore, over the 24 month treatment period, relapse
occurred in 16.5 percent of patients treated with RLAI and 31.3 percent in the quetiapine treatment
arm.
In July 2008, we announced that our partner, J&JPRD, submitted a sNDA for RISPERDAL CONSTA to
the FDA for approval as monotherapy in the maintenance treatment of bipolar I disorder to delay the
time to occurrence of mood episodes in adults. Bipolar disorder is a brain disorder that causes
unusual shifts in a persons mood, energy and ability to function. Characterized by debilitating
mood swings, from extreme highs (mania) to extreme lows (depression), bipolar I disorder affects
5.7 million, or 2.6 percent, of the American adult population in any given year.
In October 2008, the FDA approved the deltoid muscle of the arm as a new injection site for
RISPERDAL CONSTA. RISPERDAL CONSTA was previously approved as a gluteal injection only.
VIVITROL
We developed VIVITROL, an extended-release Medisorb formulation of naltrexone, for the
treatment of alcohol dependence in patients who are able to abstain from drinking in an outpatient
setting and are not actively drinking prior to treatment initiation. Alcohol dependence is a
serious and chronic brain disease characterized by cravings for alcohol, loss of control over
drinking, withdrawal symptoms and an increased tolerance for alcohol. Adherence to medication is
particularly challenging with this patient population. In clinical trials, when used in combination
with psychosocial support, VIVITROL was shown to reduce the number of drinking days and heavy
drinking days and to prolong abstinence in patients who abstained from alcohol the week prior to
starting treatment. Each injection of VIVITROL provides medication for one month and alleviates the
need for patients to make daily medication dosing decisions. VIVITROL was approved by the FDA in
April 2006 and launched in June 2006. Cephalon is primarily responsible for marketing VIVITROL in
the U.S. We are the exclusive manufacturer of VIVITROL.
16
In April 2007, we submitted a Marketing Authorization Application (MAA) for VIVITROL for the
treatment of alcohol dependence to regulatory authorities in the U.K. and Germany based on the
single pivotal clinical study used to register VIVITROL in the U.S. In July 2008, based on feedback
from the U.K. health authorities that data from a single study would not be sufficient to register
VIVITROL in the U.K. and Germany, we withdrew the MAA.
In December 2007, we entered into an exclusive agreement with Cilag to commercialize VIVITROL
for the treatment of alcohol dependence and opioid dependence in Russia and other countries in the
CIS. In August 2008, we announced that Cilag received approval from the Russian regulatory
authority to market VIVITROL for the treatment of alcohol dependence. Janssen-Cilag, an affiliate
company of Cilag, will commercialize VIVITROL. We will retain exclusive development and marketing
rights to VIVITROL in all markets outside the U.S., Russia and other countries in the CIS. We are
responsible for manufacturing VIVITROL and will receive manufacturing fees and royalties based on
product sales.
In June 2008, we initiated a randomized, multi-center registration study of VIVITROL for the
treatment of opioid dependence. The multi-center study is designed to assess the efficacy and
safety of VIVITROL in approximately 200 patients diagnosed with opioid dependence. The clinical
data from this study will form the basis of a sNDA to the FDA for VIVITROL for the treatment of
opioid dependence, a chronic brain disease.
Exenatide Once Weekly
We are collaborating with Amylin on the development of exenatide once weekly for the treatment
of type 2 diabetes. Exenatide once weekly is an injectable formulation of Amylins
BYETTA® (exenatide) which is an injection administered twice daily. Diabetes is a
disease in which the body does not produce or properly use insulin. Diabetes can result in serious
health complications, including cardiovascular, kidney and nerve disease. BYETTA was approved by
the FDA in April 2005 as adjunctive therapy to improve blood sugar control in patients with type 2
diabetes who have not achieved adequate control on metformin and/or sulfonylurea; two commonly used
oral diabetes medications. In December 2006, the FDA approved BYETTA as an add-on therapy for
people with type 2 diabetes unable to achieve adequate glucose control on thiazolidinedione, a
class of diabetes medications. Amylin has an agreement with Eli Lilly and Company (Lilly) for the
development and commercialization of exenatide, including exenatide once weekly. Exenatide once
weekly is being developed with the goal of providing patients with an effective and more
patient-friendly treatment option.
In June 2008, we, Amylin and Lilly announced positive results from a 52-week, open-label
clinical study that showed the durable efficacy of exenatide once weekly. At 52 weeks, patients
taking exenatide once weekly showed an average A1C improvement of 2 percent and an average weight
loss of 9.5 pounds. The study also showed that patients who switched from BYETTA injection after
30 weeks to exenatide once weekly experienced additional improvements in A1C and fasting plasma
glucose. Seventy-four percent of all patients in the study achieved an endpoint of A1C of 7 percent
or less at 52 weeks. Exenatide once weekly was well tolerated, with no major hypoglycemia events
regardless of background therapy and nausea was predominantly mild and transient.
In November 2008, we announced that Amylin had received feedback from the FDA that the data it
submitted from its in vitro in vivo correlation studies to demonstrate comparability between
exenatide once weekly manufactured by Alkermes in our facility and used in previous clinical
studies and exenatide once weekly manufactured on a commercial scale in Amylins Ohio facility did
not meet FDA requirements. Amylin is in active discussions with the FDA regarding options to
enable a New Drug Application, or NDA, submission by the end of the first half of 2009. If Amylin
is required to initiate a new clinical study, the timing of the NDA submission would depend on the
parameters of the new study, and the submission could be delayed beyond the previously stated
filing timeline of by the end of the first half of 2009.
ALKS 29
We are developing ALKS 29, an oral compound for the treatment of alcohol dependence. In July
2007, we announced positive preliminary results from a phase 1/2 multi-center, randomized,
double-blind, placebo- controlled, eight-week study that was designed to assess the efficacy and
safety of ALKS 29 in approximately 150 alcohol dependent patients. In the study, ALKS 29 was
generally well tolerated and led to both a statistically significant increase in the percent of
days abstinent and a decrease in drinking compared to placebo when combined with psychosocial
therapy. The study endpoints included the percent of days abstinent, percent of heavy drinking
days and number of drinks per day. Heavy drinking was defined as five or more drinks per day for
men and four or
17
more drinks per day for women. We plan to initiate additional clinical studies to support ALKS
29 during calendar year 2008.
ALKS 27
Using our AIR pulmonary technology, we are independently developing an inhaled trospium
product for the treatment of chronic obstructive pulmonary disease (COPD). COPD is a serious,
chronic disease characterized by a gradual loss of lung function. Last year, we reported positive
clinical data from a phase 2a study showing that single doses of ALKS 27 demonstrated a rapid onset
of action and produced a significant improvement in lung function compared to placebo. We are
manufacturing clinical trial material for a phase 2 dose ranging study expected to start in the
first quarter of calendar 2009.
ALKS 33
ALKS 33 is a novel opioid modulator, identified from the library of compounds in-licensed from
Rensselaer Polytechnic Institute (RPI). These compounds represent an opportunity for us to
develop important therapeutics for a broad range of diseases and medical conditions, including
addiction, pain and other central nervous system disorders. In July 2008, we announced positive
preclinical results for three proprietary molecules targeting opioid receptors, including ALKS 33.
The study results included efficacy data from an ethanol drinking behavior model in rodents, a
well-characterized model for evaluating the effects of potential therapeutics targeting opioid
receptors. Results showed that single, oral doses of our novel molecules significantly reduced the
ethanol drinking behavior in rodents, with an average reduction from baseline ranging from
35 percent to 50 percent for the proprietary molecules compared to 10 percent for the active
control (P less than 0.05). Details from an evaluation of the in vivo pharmacology,
pharmacokinetics and in vitro metabolism were also presented. Data showed that the molecules have
improved metabolic stability compared to the active control when cultured with human hepatocytes
(liver cells), suggesting that they are not readily metabolized by the liver. Pharmacokinetic
results showed that the oral bioavailability of ALKS 33 was significantly greater than that of the
active control. We are on track to file our Investigational New Drug Application (IND) and begin
a phase 1 study of ALKS 33 in healthy volunteers by the end of calendar 2008.
Critical Accounting Policies
The discussion and analysis of our financial condition and results of operations is based on
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States of America. The preparation of these financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets and
liabilities and the disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the reporting period. Actual
results may differ from these estimates under different assumptions or conditions. Refer to
Part II, Item 7 of our Annual Report on Form 10-K for the year ended March 31, 2008 in the
Critical Accounting Policies section for a discussion of our critical accounting policies.
Results of Operations
Net income for the three months ended September 30, 2008 was $1.7 million, or $0.02 per common
share basic and diluted, as compared to net income of $7.7 million, or $0.08 per common share
basic and $0.07 per common share diluted, for the three months ended September 30, 2007.
Net income for the six months ended September 30, 2008 was $31.4 million, or $0.33 per common
share basic and $0.32 per common share diluted, as compared to net income of $16.4 million, or
$0.16 per common share basic and diluted, for the six months ended September 30, 2007.
18
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Manufacturing revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
30.7 |
|
|
$ |
22.9 |
|
|
$ |
7.8 |
|
|
$ |
66.7 |
|
|
$ |
53.1 |
|
|
$ |
13.6 |
|
VIVITROL |
|
|
2.3 |
|
|
|
1.2 |
|
|
|
1.1 |
|
|
|
5.0 |
|
|
|
2.5 |
|
|
|
2.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total manufacturing revenue |
|
|
33.0 |
|
|
|
24.1 |
|
|
|
8.9 |
|
|
|
71.7 |
|
|
|
55.6 |
|
|
|
16.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty revenue |
|
|
8.4 |
|
|
|
7.4 |
|
|
|
1.0 |
|
|
|
17.0 |
|
|
|
14.3 |
|
|
|
2.7 |
|
Research and development
revenue under collaborative
arrangements |
|
|
5.3 |
|
|
|
21.2 |
|
|
|
(15.9 |
) |
|
|
36.7 |
|
|
|
44.7 |
|
|
|
(8.0 |
) |
Net collaborative profit |
|
|
0.6 |
|
|
|
5.9 |
|
|
|
(5.3 |
) |
|
|
1.9 |
|
|
|
12.9 |
|
|
|
(11.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
47.3 |
|
|
$ |
58.6 |
|
|
$ |
(11.3 |
) |
|
$ |
127.3 |
|
|
$ |
127.5 |
|
|
$ |
(0.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in RISPERDAL CONSTA manufacturing revenues for the three and six months ended
September 30, 2008, as compared to the three and six months ended September 30, 2007, was primarily
due to a 25% and 16% increase, respectively, in the units of RISPERDAL CONSTA shipped to Janssen.
There was also a slight increase in the net sales price of RISPERDAL CONSTA in the three and six
months ended September 30, 2008, as compared to the three and six months ended September 30, 2007,
which was due in part to fluctuations in the exchange ratio of the U.S. dollar and the foreign
currencies of the countries in which the product was sold. See Part I, Item 3. Quantitative and
Qualitative Disclosures about Market Risk for information on foreign currency exchange rate risk
related to RISPERDAL CONSTA revenues.
Under our manufacturing and supply agreement with Janssen, we earn manufacturing revenues when
product is shipped to Janssen, based on a percentage of Janssens estimated unit net sales price.
Revenues include a quarterly adjustment from Janssens estimated unit net sales price to Janssens
actual unit net sales price for product shipped. In the three and six months ended September 30,
2008 and 2007, our RISPERDAL CONSTA manufacturing revenues were based on an average of 7.5% of
Janssens unit net sales price of RISPERDAL CONSTA. We anticipate that we will earn manufacturing
revenues at 7.5% of Janssens unit net sales price of RISPERDAL CONSTA for product shipped in the
fiscal year ending March 31, 2009 and beyond.
VIVITROL manufacturing revenues for the three and six months ended September 30, 2008
consisted of $1.7 million and $2.8 million, respectively, of billings to Cephalon for failed batches
and $0 and $1.4 million, respectively, for shipments of VIVITROL to Cephalon and $0.4 million for shipments of VIVITROL
to Janssen-Cilag to support commercialization of VIVITROL in Russia. In addition, VIVITROL
manufacturing revenues for the three and six months ended September 30, 2008 included $0.2 million
and $0.4 million, respectively, of milestone revenue related to manufacturing profit on VIVITROL
under our arrangement with Cephalon, which equals a 10% markup on VIVITROL cost of goods
manufactured and draws down from unearned milestone revenue from Cephalon.
VIVITROL manufacturing revenues for the three and six months ended September 30, 2007
consisted of billings to Cephalon for idle capacity costs and no product was shipped to
them during these reporting periods. VIVITROL manufacturing revenues for the three and six months
ended September 30, 2007 included $0.1 million and $0.2 million, respectively, of milestone revenue
related to the manufacturing profit on VIVITROL under our arrangement with Cephalon, which equals a
10% markup on VIVITROL cost of goods manufactured and draws down from unearned milestone revenue
from Cephalon.
Royalty revenues for the three and six months ended September 30, 2008 and 2007 were related
to sales of RISPERDAL CONSTA. Under our license agreements with Janssen, we record royalty revenues
equal to 2.5% of Janssens net sales of RISPERDAL CONSTA in the period that the product is sold by
Janssen. Royalty revenues for the three and six months ended September 30, 2008 were based on
RISPERDAL CONSTA sales of $337.5 million and $680.7 million, respectively. Royalty revenues for the
three and six months ended September 30, 2007 were based on RISPERDAL CONSTA sales of $293.6
million and $572.3 million, respectively. The increase in sales of RISPERDAL CONSTA for the
three and six months ended September 30, 2008, as compared to the three and six months ended
September 30, 2007, was due in part to fluctuations in the exchange ratio of the U.S. dollar and
the foreign currencies of the countries in which the product was sold. See Part I, Item 3.
Quantitative and Qualitative Disclosures about Market Risk for information on foreign currency
exchange rate risk related to RISPERDAL CONSTA revenues.
19
The decrease in research and development revenue under collaborative arrangements (R&D
Revenue) for the three and six months ended September 30, 2008, as compared to the three and six
months ended September 30, 2007, was primarily due to the termination of the AIR Insulin
development program in March 2008 and the AIR parathyroid hormone (AIR PTH) development program
in September 2007, and reductions in revenues under the exenatide once weekly development program.
In June 2008, we entered into an agreement with Lilly in connection with their termination of the
development and license agreements and supply agreement for the development of AIR Insulin (the
AIR Insulin Termination Agreement). Under the AIR Insulin Termination Agreement, we received
$40.0 million in cash as payment for all services we had performed through the date of the AIR
Insulin Termination Agreement. We previously recognized $14.5 million of this payment as R&D
revenue in the year ended March 31, 2008 and recognized $25.5 million of this payment as R&D
revenue in the three months ended June 30, 2008. Revenues from the AIR Insulin development program
totaled $12.0 million and $25.9 million for the three and six months ended September 30, 2007,
respectively. Revenues from the AIR PTH development program, which was terminated during the three
months ended September 30, 2007, totaled $1.8 million and $4.9 million in the three and six months
ended September 30, 2007, respectively. We did not record any revenues under the AIR PTH
development program in the three and six months ended September 30, 2008.
Net collaborative profit for the three and six months ended September 30 consists of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Milestone revenue cost recovery |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
5.3 |
|
Milestone revenue license |
|
|
1.3 |
|
|
|
1.3 |
|
|
|
2.6 |
|
|
|
2.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total milestone revenue cost recovery and license |
|
|
1.3 |
|
|
|
1.3 |
|
|
|
2.6 |
|
|
|
7.9 |
|
Net payments (to) from Cephalon |
|
|
(0.7 |
) |
|
|
4.6 |
|
|
|
(0.7 |
) |
|
|
5.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net collaborative profit |
|
$ |
0.6 |
|
|
$ |
5.9 |
|
|
$ |
1.9 |
|
|
$ |
12.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We were responsible to fund the first $124.6 million of cumulative net losses incurred on
VIVITROL (the cumulative net loss cap). VIVITROL reached the cumulative net loss cap in April
2007, at which time Cephalon became responsible to fund all net losses incurred on VIVITROL through
December 31, 2007. Beginning January 1, 2008, all net profits or losses earned on VIVITROL within
the collaboration are divided between us and Cephalon in approximately equal shares. The net
profits earned or losses incurred on VIVITROL are dependent upon end-market sales and on the level
of expenditures by both us and Cephalon in developing, manufacturing and commercializing VIVITROL,
all of which is subject to change. Gross sales of VIVITROL by Cephalon were $4.7 million and
$9.5 million for the three and six months ended September 30, 2008, respectively, and $4.7 million
and $8.8 million for the three and six months ended September 30, 2007, respectively. Through
September 30, 2008, the cumulative net losses on VIVITROL were $190.7 million, of which
$75.9 million was incurred by us on behalf of the collaboration and $114.8 million was incurred by
Cephalon on behalf of the collaboration.
For the three and six months ended September 30, 2008, we recognized no milestone revenue
cost recovery, as VIVITROL had reached the cumulative loss cap prior to the reporting periods. For
the three and six months ended September 30, 2007, we recognized $0 and $5.3 million, respectively,
of milestone revenue cost recovery, respectively, to offset net losses on VIVITROL that we funded
under the cumulative loss cap.
For the three and six months ended September 30, 2008 and 2007, we recognized $1.3 million and
$2.6 million, respectively, of milestone revenue related to the licenses provided to Cephalon to
commercialize VIVITROL. The license revenue is recognized on a straight-line basis over 10 years.
During the three and six months ended September 30, 2008, we made net payments of $0.7 million
to Cephalon under the product loss sharing terms of the arrangement. During the three and six
months ended September 30, 2007, we received net payments of $4.6 and $5.0 million, respectively,
from Cephalon under the product loss sharing terms of the arrangement.
20
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Costs of goods manufactured: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA |
|
$ |
8.1 |
|
|
$ |
8.1 |
|
|
$ |
|
|
|
$ |
18.9 |
|
|
$ |
17.2 |
|
|
$ |
1.7 |
|
VIVITROL |
|
|
4.0 |
|
|
|
1.1 |
|
|
|
2.9 |
|
|
|
7.5 |
|
|
|
2.2 |
|
|
|
5.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cost of goods manufactured |
|
|
12.1 |
|
|
|
9.2 |
|
|
|
2.9 |
|
|
|
26.4 |
|
|
|
19.4 |
|
|
|
7.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
19.7 |
|
|
|
28.3 |
|
|
|
(8.6 |
) |
|
|
42.0 |
|
|
|
60.9 |
|
|
|
(18.9 |
) |
Selling, general and administrative |
|
|
11.7 |
|
|
|
14.5 |
|
|
|
(2.8 |
) |
|
|
23.6 |
|
|
|
29.9 |
|
|
|
(6.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
$ |
43.5 |
|
|
$ |
52.0 |
|
|
$ |
(8.5 |
) |
|
$ |
92.0 |
|
|
$ |
110.2 |
|
|
$ |
(18.2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RISPERDAL CONSTA cost of goods manufactured for the three months ended September 30, 2008 and
2007 was comparable in amount due to a 25% increase in the number of units shipped to Janssen
offset by a decrease in the unit cost of RISPERDAL CONSTA shipped. The increase in RISPERDAL CONSTA
cost of goods manufactured for the six months ended September 30, 2008, as compared to the six
months ended September 30, 2007, was due to a 16% increase in units of RISPERDAL CONSTA shipped to
Janssen, partially offset by a decrease in the unit cost of RISPERDAL CONSTA shipped.
VIVITROL cost of goods manufactured for the three months ended September 30, 2008 consisted of
$2.6 million related to the restart of the VIVITROL manufacturing line following a shutdown of the
line, $1.1 million of cost for failed batches and $0.3 million for shipments of VIVITROL to
Janssen-Cilag to support the commercialization of VIVITROL in Russia. Cost of goods manufactured
for VIVITROL for the three months ended September 30, 2007 consisted of idle capacity
costs, which consisted of current period manufacturing costs related to underutilized VIVITROL
manufacturing capacity.
VIVITROL cost of goods manufactured for the six months ended September 30, 2008 consisted of
$2.6 million related to the restart of the VIVITROL manufacturing line following a shutdown of the
line, $3.3 million of cost for failed batches, $1.3 million for shipments of VIVITROL to Cephalon
and $0.3 million of shipments to Janssen-Cilag to support the commercialization of VIVITROL in
Russia. Cost of goods manufactured for VIVITROL for the six months ended September 30, 2007
consisted entirely of idle capacity costs, which consisted of current period manufacturing costs
related to underutilized VIVITROL manufacturing capacity.
The decrease in research and development expenses for the three and six months ended
September 30, 2008, as compared to the three and six months ended September 30, 2007, was primarily
due to the termination of the AIR Insulin development program and the closure of our AIR commercial
manufacturing facility in March 2008 (the 2008 Restructuring). As a result, our personnel-related
costs, including share-based compensation expense, and our facility related costs, including
occupancy and depreciation, decreased compared to the three and six months ended September 30,
2007. In addition, the use of raw materials and third party packaging of the clinical drug product
used during the development of the AIR Insulin development program decreased in the three and six
months ended September 30, 2008, as compared to the three and six months ended September 30, 2007.
Also, no expenses were incurred in fiscal 2009 on the AIR PTH development program, which was
terminated during the three months ended September 30, 2007.
A significant portion of our research and development expenses (including laboratory supplies,
travel, dues and subscriptions, recruiting costs, temporary help costs, consulting costs and
allocable costs such as occupancy and depreciation) are not tracked by project as they benefit
multiple projects or our technologies in general. Expenses incurred to purchase specific services
from third parties to support our collaborative research and development activities are tracked by
project and are reimbursed to us by our partners. We generally bill our partners under
collaborative arrangements using a negotiated full-time equivalent (FTE) or hourly rate. This
rate has been established by us based on our annual budget of employee compensation, employee
benefits and the billable non-project-specific costs mentioned above and is generally increased
annually based on increases in the consumer price index. Each collaborative partner is billed using
a negotiated FTE or hourly rate for the hours worked by our employees on a particular project, plus
direct external costs, if any. We account for our research and development expenses on a
departmental and functional basis in accordance with our budget and management practices.
21
The decrease in selling, general and administrative expenses for the three and six months
ended September 30, 2008, as compared to the three and six months ended September 30, 2007, was
primarily due to a decrease in professional fees, consisting of legal and consulting fees,
decreased personnel related costs, including share-based compensation expense, and decreased
taxes.
Other (Expense) Income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Interest income |
|
$ |
2.7 |
|
|
$ |
4.2 |
|
|
$ |
(1.5 |
) |
|
$ |
6.3 |
|
|
$ |
8.7 |
|
|
$ |
(2.4 |
) |
Interest expense |
|
|
(4.2 |
) |
|
|
(4.1 |
) |
|
|
(0.1 |
) |
|
|
(8.5 |
) |
|
|
(8.2 |
) |
|
|
(0.3 |
) |
Other (expense) income |
|
|
(0.7 |
) |
|
|
1.2 |
|
|
|
(1.9 |
) |
|
|
(0.8 |
) |
|
|
1.2 |
|
|
|
(2.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (expense) income |
|
$ |
(2.2 |
) |
|
$ |
1.3 |
|
|
$ |
(3.5 |
) |
|
$ |
(3.0 |
) |
|
$ |
1.7 |
|
|
$ |
(4.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The decrease in interest income for the three and six months ended September 30, 2008, as
compared to the three and six months ended September 30, 2007, was due to lower interest rates
earned during the comparable periods, partially offset by higher average balances of cash and
investments. As our investments in corporate debt securities mature or are called by the issuers,
we have reinvested the proceeds primarily in U.S. treasuries and agency securities. As such, we
expect our interest earnings to decrease as compared to prior periods. Interest expense for the
three and six months ended September 30, 2008 and 2007 was comparable in amount due to reduced
interest expense as a result of the purchase of approximately 44% our non-recourse RISPERDAL CONSTA
secured 7% notes (the 7% Notes), offset by debt extinguishment charges related to the purchases
of our 7% Notes. During the six months ended September 30, 2008, we purchased, in three privately
negotiated transactions, $75.0 million in original principal amount of our outstanding 7% Notes. We
recorded a loss on the extinguishment of the 7% Notes of $2.0 million during the six months ended
September 30, 2008, which was recorded as interest expense.
Other (expense) for the three and six months ended September 30, 2008 consists primarily of
the accretion of discounts related to restructurings and asset retirement obligations and an
other-than-temporary impairment on the common stock of certain publicly held companies. Other
income for the three and six months ended September 30, 2007 consisted primarily of income
recognized on the changes in the fair value of warrants of certain publicly held companies,
partially offset by the accretion of discounts related to restructurings and asset retirement
obligations and an other-than-temporary impairment on the common stock of certain publicly held
companies.
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
(In millions) |
|
2008 |
|
|
2007 |
|
|
Change |
|
|
2008 |
|
|
2007 |
|
|
Change |
|
Income tax (benefit) provision |
|
$ |
(0.1 |
) |
|
$ |
0.2 |
|
|
$ |
(0.3 |
) |
|
$ |
1.0 |
|
|
$ |
2.6 |
|
|
$ |
(1.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The income tax benefit for the three months ended September 30, 2008 and the income tax
provision for the six months ended September 30, 2008 and the three and six months ended September
30, 2007 all related to the U.S. alternative minimum tax (AMT). Included in the $0.1 million
benefit for the three months ended September 30, 2008 is $0.1 million which represents the amount
that we estimated we will benefit from as a result of the recently enacted Housing and Economic
Recovery Act of 2008. This legislation allows for certain taxpayers to forego bonus
depreciation in lieu of a refundable cash credit based on certain qualified asset
purchases. Utilization of tax loss carryforwards is limited in the calculation of AMT. The current
AMT liability is available as a credit against future tax obligations upon the full utilization or
expiration of our net operating loss carryforward.
We do not believe that inflation and changing prices have had a material impact on our results
of operations.
22
Liquidity and Capital Resources
Our financial condition is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
March 31, |
|
(In millions) |
|
2008 |
|
|
2008 |
|
Cash and cash equivalents |
|
$ |
68.5 |
|
|
$ |
101.2 |
|
Investments short-term |
|
|
263.9 |
|
|
|
240.1 |
|
Investments long-term |
|
|
93.4 |
|
|
|
119.1 |
|
|
|
|
|
|
|
|
Total cash, cash equivalents and investments |
|
$ |
425.8 |
|
|
$ |
460.4 |
|
|
|
|
|
|
|
|
Working capital |
|
$ |
354.1 |
|
|
$ |
371.1 |
|
|
|
|
|
|
|
|
Outstanding borrowings current and long-term |
|
$ |
91.9 |
|
|
$ |
160.4 |
|
|
|
|
|
|
|
|
We invest in short-term and long-term investments consisting of U.S. government debt
securities, U.S. agency debt securities, municipal debt securities, investment grade corporate debt
securities, including asset backed debt securities, and student loan backed auction rate securities
issued by major financial institutions in accordance with our documented corporate policies. Our
investment objectives are, first, to assure liquidity and conservation of capital and, second, to
obtain investment income. We performed an analysis of our investment portfolio at September 30,
2008 for impairment and determined that we had a temporary impairment of $3.5 million, attributed
primarily to our investments in corporate debt securities, including asset backed debt securities,
student loan backed auction rate securities, and an other-than-temporary impairment of $0.6 million
attributed to investments in the common stock of certain collaborative partners. Temporary
impairments are unrealized and are recorded in accumulated other comprehensive income, a component
of shareholders equity, and other-than-temporary impairments are realized and recorded in our
condensed consolidated statements of income.
At September 30, 2008, we have classified $88.7 million of our available-for-sale investments
in securities with temporary losses of $3.5 million as Investments Long-Term in the accompanying
condensed consolidated balance sheet, as we believe the recovery of the losses will extend beyond
one year and we have the intent and ability to hold the investments to recovery, which may be
maturity.
On April 1, 2008, we implemented SFAS No. 157, Fair Value Measurements (SFAS No. 157) for
our financial assets and liabilities that are re-measured and reported at fair value at each
reporting period. SFAS No. 157 provides a framework for measuring fair value and requires expanded
disclosures regarding fair value measurements. SFAS No. 157 defines fair value as the price that
would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly
transaction between market participants at the measurement date. In determining fair value,
SFAS No. 157 permits the use of various valuation approaches, including market, income and cost
approaches. SFAS No. 157 establishes a hierarchy for inputs used in measuring fair value that
maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring
that the observable inputs be used when available.
The fair value hierarchy is broken down into three levels based on the reliability of inputs.
We have categorized its cash, cash equivalents and investments within the hierarchy as follows:
Level 1 These valuations are based on a market approach using quoted prices in active
markets for identical assets. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 1 inputs include investments in money market funds,
U.S. government debt securities, U.S. agency debt securities, municipal debt securities, bank
deposits and exchange-traded equity securities of certain publicly held companies;
Level 2 These valuations are based on a market approach using quoted prices obtained from
brokers or dealers for similar securities or for securities for which we have limited visibility
into their trading volumes. Valuations of these products do not require a significant degree of
judgment. Assets utilizing Level 2 inputs consist of investments in corporate debt securities;
Level 3 These valuations are based on an income approach using certain inputs that are
unobservable and are significant to the overall fair value measurement. Valuations of these
products require a significant degree of judgment. Assets utilizing Level 3 inputs consist of
investments in auction rate securities and asset backed debt securities that are not currently
trading. In addition, we hold warrants in certain publicly held companies that are classified
using Level 3 inputs. The carrying balance of these warrants was immaterial at September 30, 2008
and March 31, 2008.
23
Our investments in auction rate securities have a cost of $10.0 million and invest in taxable
student loan revenue bonds issued by state higher education authorities which service student loans
under the Federal Family Education Loan Program. The bonds were triple A rated at the date of
purchase and are collateralized by student loans purchased by the authorities which are guaranteed
by state sponsored agencies and reinsured by the U.S. Department of Education. Liquidity for these
securities is typically provided by an auction process that resets the applicable interest rate at
pre-determined intervals. Each of these securities had been subject to auction processes for which
there had been insufficient bidders on the scheduled auction dates and the auctions subsequently
failed. We are not able to liquidate our investments in auction rate securities until future
auctions are successful, a buyer is found outside of the auction process or the notes are redeemed
by the issuer. The securities continue to pay interest at predetermined interest rates during the
periods in which the auctions have failed.
Typically, auction rate securities trade at their par value due to the short interest rate
reset period and the availability of buyers or sellers of the securities at recurring auctions.
However, since the security auctions have failed and fair value cannot be derived from quoted
prices, we used a discounted cash flow model to determine the estimated fair value of the
securities at September 30, 2008. Our valuation analyses consider, among other items, assumptions
that market participants would use in their estimates of fair value, such as the collateral
underlying the security, the creditworthiness of the issuer and any associated guarantees, the
timing of expected future cash flows, and the expectation of the next time the security will have a
successful auction or when callability features may be exercised by the issuer. These securities
were also compared, where possible, to other observable market data with similar characteristics to
the securities held by us. Based upon this methodology, we have recorded an unrealized loss related
to our investments in auction rate securities of approximately $0.7 million to accumulated other
comprehensive income at September 30, 2008. We believe there are several significant assumptions
that are utilized in our valuation analysis, the two most critical of which are the discount rate,
which includes a provision for default and liquidity risk, and the average expected term.
At September 30, 2008, we determined that the securities had been temporarily impaired due to
the length of time each security was in an unrealized loss position, the extent to which fair value
was less than cost, financial condition and near term prospects of the issuers and our intent and
ability to hold each security for a period of time sufficient to allow for any anticipated recovery
in fair value. We do not expect the estimated fair value of these securities to decrease
significantly in the future unless credit market conditions deteriorate significantly.
Our investments in asset backed debt securities have a cost of $8.2 million and consist of
investment grade medium term floating rate notes (MTN) of Aleutian Investments, LLC (Aleutian)
and Meridian Funding Company, LLC (Meridian), which are qualified special purpose entities
(QSPE) of Ambac Financial Group, Inc. (Ambac) and MBIA, Inc. (MBIA), respectively. Ambac and
MBIA are guarantors of financial obligations and are referred to as monoline financial guarantee
insurance companies. The QSPEs, which purchase pools of assets or securities and fund the purchase
through the issuance of MTNs, have been established to provide a vehicle to access the capital
markets for asset backed debt securities and corporate borrowers. The MTNs include a sinking fund
redemption feature which match-fund the terms of redemptions to the maturity dates of the
underlying pools of assets or securities in order to mitigate potential liquidity risk to the
QSPEs. At September 30, 2008, a substantial portion of our initial investment in the Meridian
MTNs had been redeemed by MBIA through scheduled sinking fund redemptions at par value, and the
first sinking fund redemption on the Aleutian MTN is scheduled for June 2009.
The liquidity and fair value of these securities has been negatively impacted by the
uncertainty in the credit markets, and the exposure of these securities to the financial condition
of monoline financial guarantee insurance companies, including Ambac and MBIA. In June 2008, Ambac
had its triple A rating reduced to Aa3 by Moodys and double A by Standard and Poors (S&P), and
MBIA was downgraded from triple A to A2 by Moodys and double A by S&P. Both downgrades were due to
Ambacs and MBIAs inability to maintain triple A capital levels. In August 2008, S&P affirmed its
double A ratings of Ambac and MBIA with negative outlook. In September 2008, Moodys placed Ambac
and MBIA on review for possible downgrade. In November 2008, Moodys announced that it had downgraded Ambacs rating to Baa1 with a
developing outlook.
We may not be able to liquidate our investment in the securities before the scheduled
redemptions or until trading in the securities resumes in the credit markets, which may not occur.
Because the MTNs are not actively trading in the credit markets and fair value cannot be derived
from quoted prices, we used a discounted cash flow model to determine the estimated fair value of
the securities at September 30, 2008. Our valuation analyses consider, among other items,
assumptions that market participants would use in their estimates of fair value such as the
collateral
24
underlying the security, the creditworthiness of the issuer and the associated guarantees by
Ambac and MBIA, the timing of expected future cash flows, including whether the callability
features of these investments may be exercised by the issuer. Based upon this methodology, we have
an unrealized loss related to these asset backed debt securities of approximately $0.9 million in
accumulated other comprehensive income at September 30, 2008. We believe there are several
significant assumptions that are utilized in our valuation analysis, the two most critical of which
are the discount rate, which includes a provision for default and liquidity risk, and the average
expected term.
At September 30, 2008, we determined that the securities had been temporarily impaired due to
the length of time each security was in an unrealized loss position, the extent to which fair value
was less than cost, the financial condition and near term prospects of the issuers, current
redemptions made by one of the issuers and our intent and ability to hold each security for a
period of time sufficient to allow for any anticipated recovery in fair value or until scheduled
redemption. We do not expect the estimated fair value of these securities to decrease significantly
in the future unless credit market conditions deteriorate significantly or the credit ratings of
the issuers are downgraded.
We have funded our operations primarily with funds generated by our business operations and
through public offerings and private placements of debt and equity securities, bank loans, term
loans, equipment financing arrangements and payments received under research and development
agreements and other agreements with collaborators. We expect to incur significant additional
research and development and other costs in connection with collaborative arrangements and as we
expand the development of our proprietary product candidates, including costs related to
preclinical studies, clinical trials and facilities expansion. Our costs, including research and
development costs for our product candidates and sales, marketing and promotional expenses for any
future products to be marketed by us or our collaborators, if any, may exceed revenues in the
future, which may result in losses from operations. We believe that our current cash and cash
equivalents and short-term investments, combined with our unused equipment lease line, anticipated
interest income and anticipated revenues will generate sufficient cash flows to meet our
anticipated liquidity and capital requirements through at least September 30, 2009.
Operating Activities
Cash provided by operating activities was $39.2 million and $9.6 million in the six months
ended September 30, 2008 and 2007, respectively. Cash flows from operating activities in the
six months ended September 30, 2008 increased over the six months ended September 30, 2007 due to
the $40.0 million we received from Lilly related to the AIR Insulin Termination Agreement, of which
$25.5 million was recognized as revenue in the first quarter of fiscal 2009, and changes in other
working capital accounts.
Investing Activities
Cash provided by investing activities was $5.7 million and cash used in investing activities
was $12.2 million in the six months ended September 30, 2008 and 2007, respectively. During the six
months ended September 30, 2008, we had net sales of investments of $1.5 million and purchased
$3.6 million in property, plant and equipment, which was offset by $7.7 million in cash we received
on the sale of certain equipment to a collaborative partner. During the six months ended
September 30, 2007, we had net sales of investments of $2.4 million and purchased $14.6 million in
property, plant and equipment.
Financing Activities
Cash used in financing activities was $77.6 million and cash provided by financing activities
was $8.6 million for the six months ended September 30, 2008 and 2007, respectively. In the six
months ended September 30, 2008, we used $71.8 million to repurchase a portion of our outstanding
7% Notes and $13.1 million to repurchase our common stock under our publicly announced stock
repurchase program. These cash payments were partially offset by $7.2 million of cash provided from
the issuance of common stock in connection with the exercise of employee stock options. In the six
months ended September 30, 2007, we received cash of $9.1 million from the issuance of common stock
in connection with the exercise of employee stock options, offset by debt payments of $0.7 million.
Borrowings
At September 30, 2008, our borrowings consisted primarily of our 7% Notes, which had a
carrying value of $91.9 million. We are currently making interest payments on the 7% Notes, with
principal payments scheduled to begin in April 2009. In June and July 2008, in three separate
privately negotiated transactions, we purchased an
25
aggregate total of $75.0 million principal amount of the 7% Notes for $71.8 million. We
recorded a loss on the extinguishment of the notes of $2.0 million during the six months ended
September 30, 2008. As a result of the purchases, $95.0 principal amount of the 7% Notes remains
outstanding, and we will save approximately $11.2 million in interest payments over the remaining
life of the 7% notes.
Capital Requirements
We may continue to pursue opportunities to obtain additional financing in the future. Such
financing may be sought through various sources, including debt and equity offerings, corporate
collaborations, bank borrowings, arrangements relating to assets or other financing methods or
structures. The source, timing and availability of any financings will depend on market conditions,
interest rates and other factors. Our future capital requirements will also depend on many factors,
including continued scientific progress in our research and development programs (including our
proprietary product candidates), the size of these programs, progress with preclinical testing and
clinical trials, the time and costs involved in obtaining regulatory approvals, the costs involved
in filing, prosecuting and enforcing patent claims, competing technological and market
developments, the establishment of additional collaborative arrangements, the cost of manufacturing
facilities and of commercialization activities and arrangements and the cost of product
in-licensing and any possible acquisitions and, for any future proprietary products, the sales,
marketing and promotion expenses associated with marketing such products. We may from time to time
seek to retire or purchase our outstanding debt through cash purchases and/or exchanges for equity
securities, in open market purchases, privately negotiated transactions or otherwise. Such
repurchases or exchanges, if any, will depend on prevailing market conditions, our liquidity
requirements, contractual restrictions and other factors. The amounts involved may be material.
We may need to raise substantial additional funds for longer-term product development,
including development of our proprietary product candidates, regulatory approvals and manufacturing
and sales and marketing activities that we might undertake in the future. There can be no assurance
that additional funds will be available on favorable terms, if at all. If adequate funds are not
available, we may be required to curtail significantly one or more of our research and development
programs and/or obtain funds through arrangements with collaborative partners or others that may
require us to relinquish rights to certain of our technologies, product candidates or future
products.
We have an arrangement with General Electric Capital Corporation (GE) for an equipment lease
line that provides us with the ability to finance up to $18.3 million of new equipment purchases.
The equipment financing would be secured by the purchased equipment and will be subject to a
financial covenant, and this lease line expires in December 2008. At September 30, 2008, there were
no amounts outstanding under this lease line.
Capital expenditures are expected in the range from $4.0 million to $5.0 million for the year
ending March 31, 2009.
Contractual Obligations
With the exception of the repurchases of our 7% Notes, discussed above under Borrowings, and
in Note 10 to the accompanying Condensed Consolidated Financial Statements, the contractual cash
obligations disclosed in our Annual Report on Form 10-K for the year ended March 31, 2008 have not
changed materially since the date of that report.
Off-Balance Sheet Arrangements
As of September 30, 2008, we were not a party to any off-balance sheet arrangements that have,
or are reasonably likely to have, a current or future effect on our financial condition, changes in
financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or
capital resources material to investors.
26
Item 3. Quantitative and Qualitative Disclosures about Market Risk
We hold financial instruments in our investment portfolio that are sensitive to market risks.
Our investment portfolio, excluding warrants and equity securities we hold in connection with our
collaborations and licensing activities, is used to preserve capital until it is required to fund
operations. Our held-to-maturity investments are restricted and are held as collateral under
certain letters of credit related to our lease agreements. Our short-term and long-term investments
consist of U.S. government debt securities, U.S. agency debt securities, municipal debt securities,
investment grade corporate debt securities, including asset backed debt securities, and auction
rate securities. These debt securities are: (i) classified as available-for-sale; (ii) are recorded
at fair value; and (iii) are subject to interest rate risk, and could decline in value if interest
rates increase. Fixed rate interest securities may have their market value adversely impacted by a
rise in interest rates, while floating rate securities may produce less income than expected if
interest rates fall. Due in part to these factors, our future investment income may fall short of
expectation due to a fall in interest rates or we may suffer losses in principal if we are forced
to sell securities that decline in the market value due to changes in interest rates. However,
because we classify our investments in debt securities as available-for-sale, no gains or losses
are recognized due to changes in interest rates unless such securities are sold prior to maturity
or declines in fair value are determined to be other-than-temporary. Should interest rates
fluctuate by 10%, our interest income would change by approximately $1.3 million over an annual
period. Due to the conservative nature of our short-term and long-term investments and our
investment policy, we do not believe that we have a material exposure to interest rate risk.
Although our investments are subject to credit risk, our investment policies specify credit quality
standards for our investments and limit the amount of credit exposure from any single issue, issuer
or type of investment.
Our investments that are subject to the greatest credit risk at this time are our investments
in asset backed debt securities and auction rate securities. Holding all other factors constant, if
we were to increase the discount rate utilized in our valuation analysis of the asset backed debt
securities and auction rate securities by 50 basis points (one-half of a percentage point), this
change would have the effect of reducing the fair value of our investments by approximately
$0.1 million and $0.2 million at September 30, 2008, respectively. Similarly, holding all other
factors constant, if we were to assume that the expected term of the asset backed debt securities
was the full contractual maturity, which could be through the year 2012, this change would have the
effect of reducing the fair value of these securities by approximately $0.6 million at
September 30, 2008. As it relates to auction rate securities, holding all other factors constant,
if we were to increase the average expected term utilized in our fair value analysis by one year,
this change would have the effect of reducing the fair value of these securities by approximately
$0.1 million at September 30, 2008.
We also hold warrants to purchase the equity securities of certain publicly held companies
that are considered derivative instruments and are recorded at fair value. These securities are
sensitive to changes in interest rates. Interest rate changes would result in a change in the fair
value of warrants due to the difference between the market interest rate and the rate at the date
of purchase. A 10% increase or decrease in market interest rates would not have a material impact
on our consolidated financial statements.
At September 30, 2008, the fair value of our 7% Notes approximated the carrying value. The
interest rate on these notes, and our capital lease obligations, are fixed and therefore not
subject to interest rate risk.
Foreign Currency Exchange Rate Risk
The manufacturing and royalty revenues we receive on RISPERDAL CONSTA are a percentage of the
net sales made by our collaborative partner, Janssen. Some of these sales are made in foreign
countries and are denominated in foreign currencies. The manufacturing and royalty payment on these
foreign sales is calculated initially in the foreign currency in which the sale is made and is then
converted into U.S. dollars to determine the amount that Janssen pays us for manufacturing and
royalty revenues. Fluctuations in the exchange ratio of the U.S. dollar and these foreign
currencies will have the effect of increasing or decreasing our manufacturing and royalty revenues
even if there is a constant amount of sales in foreign currencies. For example, if the U.S. dollar
weakens against a foreign currency, then our manufacturing and royalty revenues will increase given
a constant amount of sales in such foreign currency.
27
The impact on our manufacturing and royalty revenues from foreign currency exchange rate risk
is based on a number of factors, including the exchange rate (and the change in the exchange rate
from the prior period) between a foreign currency and the U.S. dollar, and the amount of RISPERDAL
CONSTA sales by Janssen that are denominated in foreign currencies.
For the six months ended September 30, 2008, an average 10%
strengthening of the U.S. dollar relative to the currencies in
which RISPERDAL CONSTA is sold, our manufacturing and royalty
revenues would have been reduced by approximately $4.7 million and $1.1 million, respectively. We do not currently hedge our foreign currency exchange rate risk.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
We have carried out an evaluation, under the supervision and the participation of our
management, including our principal executive officer and principal financial officer, of the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in
Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Securities Exchange
Act) at September 30, 2008. Based upon that evaluation, our principal executive officer and
principal financial officer concluded that, at September 30, 2008, our disclosure controls and
procedures are effective in providing reasonable assurance that (a) the information required to be
disclosed by us in the reports that we file or submit under the Securities Exchange Act is
recorded, processed, summarized and reported within the time periods specified in the Securities
and Exchange Commissions (SEC) rules and forms, and (b) such information is accumulated and
communicated to our management, including our principal executive officer and principal financial
officer, as appropriate to allow timely decisions regarding required disclosure. In designing and
evaluating our disclosure controls and procedures, our management recognized that any controls and
procedures, no matter how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and our management necessarily was required to apply its
judgment in evaluating the cost-benefit relationship of possible controls and procedures.
(b) Change in Internal Control over Financial Reporting
During the period covered by this report, there have been no changes in our internal control
over financial reporting that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
28
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Please see the Legal Proceedings section of our Annual Report on Form 10-K for the year ended
March 31, 2008 for more information on litigation to which we are a party.
Item 1A. Risk Factors
The current credit and financial market conditions may exacerbate certain risks affecting our
business.
Sales of our products are dependent, in large part, on reimbursement from government health
administration authorities, private health insurers, distribution partners and other organizations.
As a result of the current credit and financial market conditions, these organizations may be
unable to satisfy their reimbursement obligations or may delay payment. In addition, federal and
state health authorities may reduce Medicare and Medicaid reimbursements, and private insurers may
increase their scrutiny of claims. A reduction in the availability or extent of reimbursement could
negatively affect our product sales and revenue. Customers may also reduce spending during times of
economic uncertainty.
In addition, we rely on third parties for several important aspects of our business. For
example, we depend upon collaborators for both manufacturing and royalty revenue and the clinical
development of collaboration products, we use third-party contract research organizations for many
of our clinical trials, and we rely upon several single source providers of raw materials for the
manufacture of our products. Due to the recent tightening of global credit and the disruption in
the financial markets, there may be a disruption or delay in the performance of our third-party
contractors, suppliers or collaborators. If such third parties are unable to satisfy their
commitments to us, our business would be adversely affected.
Our investment portfolio may become impaired by further deterioration of the capital markets.
As a result of current adverse financial market conditions, investments in some financial
instruments, such as auction rate securities and asset backed debt securities, may pose risks
arising from liquidity and credit concerns. We have limited holdings of these investments in our
portfolio; however, the current disruptions in the credit and financial markets have negatively
affected investments in many industries, including those in which we invest. The current global
economic crisis has had, and may continue to have, a negative impact on the market values of the
investments in our investment portfolio. We cannot predict future market conditions or market
liquidity and there can be no assurance that the markets for these securities will not deteriorate
further or that the institutions that these investments are with will be able to meet their debt
obligations at the time we may need to liquidate such investments or until such time as the
investments mature. Although we currently have no plans to access the equity or debt markets to
meet capital or liquidity needs, constriction and volatility in these markets may restrict future
flexibility to do so if unforeseen capital or liquidity needs were to arise.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
A summary of our stock repurchase activity for the six months ended September 30, 2008 is as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approximate Dollar |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Value of Shares |
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
|
that May Yet |
|
|
|
Total Number |
|
|
Average |
|
|
Purchased as |
|
|
be Purchased |
|
|
|
of Shares |
|
|
Price Paid |
|
|
Part of a Publicly |
|
|
Under the Program |
|
Period |
|
Purchased(a) |
|
|
per Share |
|
|
Announced Program(a) |
|
|
(in millions) |
|
April 1 through April 30 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
81.6 |
|
May 1 through May 31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81.6 |
|
June 1 through June 30 |
|
|
1,038,455 |
|
|
|
12.11 |
|
|
|
1,038,455 |
|
|
|
109.1 |
|
July 1 through July 31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
109.1 |
|
August 1 through August 31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
109.1 |
|
September 1 through September 30 |
|
|
38,700 |
|
|
|
12.89 |
|
|
|
38,700 |
|
|
$ |
108.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,077,155 |
|
|
$ |
12.14 |
|
|
|
1,077,155 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29
|
|
|
(a) |
|
In November 2007, our board of directors authorized a program to
repurchase up to $175.0 million of our common stock to be repurchased
at the discretion of management from time to time in the open market
or through privately negotiated transactions. The repurchase program
has no set expiration date and may be suspended or discontinued at any
time. We publicly announced the share repurchase program in our press
release dated November 21, 2007. In June 2008, the board of directors
authorized the expansion of this repurchase program by an additional
$40.0 million, bringing the total authorization under this program to
$215.0 million. We publicly announced the expansion of the repurchase
program in our press release dated June 16, 2008. |
In addition to the stock repurchases above, during the three and six months ended
September 30, 2008, we acquired, by means of net share settlements, 583 and 35,532 shares of
Alkermes common stock, at an average price of $13.01 and $12.70 per share, respectively, related to
the vesting of employee stock awards to satisfy withholding tax obligations. In addition, during
the three and six months ended September 30, 2008, we acquired 9,176 shares of Alkermes common
stock, at an average price of $12.66 per share, tendered by employees as payment of the exercise
price of stock options granted under our equity compensation plans.
Item 5. Other Information
The Companys policy governing transactions in its securities by its directors, officers and
employees permits its officers, directors and employees to enter into trading plans in accordance
with Rule 10b5-1 under the Exchange Act. During the three months ended September 30, 2008, Mr. James M.
Frates, an executive officer of the Company, entered into a trading plan in accordance with Rule
10b5-1 and the Companys policy governing transactions in its securities by its directors, officers
and employees. The Company undertakes no obligation to update or revise the information provided
herein, including for revision or termination of an established trading plan.
Item 6. Exhibits
(a) List of Exhibits:
|
|
|
Exhibit |
|
|
No. |
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(furnished herewith). |
30
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
ALKERMES, INC.
(Registrant)
|
|
|
By: |
/s/ David A. Broecker
|
|
|
|
David A. Broecker |
|
|
|
President and Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ James M. Frates
|
|
|
|
James M. Frates |
|
|
|
Senior Vice President, Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer) |
|
|
Date: November 7, 2008
31
EXHIBIT INDEX
|
|
|
Exhibit |
|
|
No |
|
|
|
31.1
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
31.2
|
|
Rule 13a-14(a)/15d-14(a) Certification (furnished herewith). |
|
|
|
32.1
|
|
Certification pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(furnished herewith). |
32