e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
Mark One
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þ |
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Quarterly Report Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934 |
For the quarterly period ended September 30, 2007
or
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o |
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Transition Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 |
For the transition period from to .
Commission File Number: 0-20720
LIGAND PHARMACEUTICALS INCORPORATED
(Exact Name of Registrant as Specified in its Charter)
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|
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
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77-0160744
(I.R.S. Employer
Identification No.) |
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10275 Science Center Drive
San Diego, CA
(Address of Principal Executive Offices)
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92121-1117
(Zip Code) |
Registrants Telephone Number, Including Area Code: (858) 550-7500
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, or a non-accelerated filer. See definition of accelerated filer and large accelerated
filer in Rule 12b-2 of the Exchange Act. (Check one):
Large Accelerated Filer o Accelerated Filer þ Non-Accelerated Filer 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
As of October 31, 2007, the registrant had 95,433,477 shares of common stock outstanding.
LIGAND PHARMACEUTICALS INCORPORATED
QUARTERLY REPORT
FORM 10-Q
TABLE OF CONTENTS
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* |
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No information provided due to inapplicability of item. |
2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share data)
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September 30, |
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December 31, |
|
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2007 |
|
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2006 |
|
ASSETS |
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|
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|
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Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
69,301 |
|
|
$ |
158,401 |
|
Short-term investments |
|
|
29,091 |
|
|
|
13,447 |
|
Restricted cash |
|
|
|
|
|
|
38,814 |
|
Accounts receivable, net |
|
|
14 |
|
|
|
11,521 |
|
Inventories, net |
|
|
|
|
|
|
3,856 |
|
Other current assets |
|
|
2,629 |
|
|
|
9,518 |
|
Current portion of co-promote termination payments receivable |
|
|
14,740 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
115,775 |
|
|
|
235,557 |
|
Restricted investments |
|
|
1,411 |
|
|
|
1,826 |
|
Property and equipment, net |
|
|
3,434 |
|
|
|
5,551 |
|
Acquired technology and product rights, net |
|
|
|
|
|
|
83,083 |
|
Long-term portion of co-promote termination payments receivable |
|
|
80,935 |
|
|
|
|
|
Restricted indemnity account |
|
|
9,969 |
|
|
|
|
|
Other assets |
|
|
|
|
|
|
36 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
211,524 |
|
|
$ |
326,053 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
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|
|
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Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
10,448 |
|
|
$ |
12,259 |
|
Accrued liabilities |
|
|
30,870 |
|
|
|
46,509 |
|
Current portion of deferred revenue, net |
|
|
|
|
|
|
57,981 |
|
Current portion of deferred gain |
|
|
1,964 |
|
|
|
1,964 |
|
Current portion of co-promote termination liability |
|
|
14,740 |
|
|
|
12,179 |
|
Current portion of equipment financing obligations |
|
|
1,810 |
|
|
|
2,168 |
|
Note payable |
|
|
|
|
|
|
37,750 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
59,832 |
|
|
|
170,810 |
|
Long-term portion of co-promote termination liability |
|
|
80,935 |
|
|
|
81,149 |
|
Long-term portion of equipment financing obligations |
|
|
889 |
|
|
|
2,156 |
|
Long-term portion of deferred revenue, net |
|
|
2,546 |
|
|
|
2,546 |
|
Long-term portion of deferred gain |
|
|
25,747 |
|
|
|
27,220 |
|
Other long-term liabilities |
|
|
2,940 |
|
|
|
2,475 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
172,889 |
|
|
|
286,356 |
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
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|
Common stock subject to conditional redemption; 997,568 shares issued and
outstanding at September 30, 2007 and December 31, 2006 |
|
|
12,345 |
|
|
|
12,345 |
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Convertible preferred stock, $0.001 par value; 5,000,000 shares
authorized; none issued |
|
|
|
|
|
|
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|
Common stock, $0.001 par value; 200,000,000 shares authorized; 100,324,741 and
99,553,504 shares issued at September 30, 2007 and December 31, 2006,
respectively |
|
|
100 |
|
|
|
100 |
|
Additional paid-in capital |
|
|
650,196 |
|
|
|
891,446 |
|
Accumulated other comprehensive loss |
|
|
(110 |
) |
|
|
(481 |
) |
Accumulated deficit |
|
|
(587,450 |
) |
|
|
(862,802 |
) |
|
|
|
|
|
|
|
|
|
|
62,736 |
|
|
|
28,263 |
|
Treasury stock, at cost; 5,480,633 and 73,842 shares at September 30, 2007
and December 31, 2006, respectively |
|
|
(36,446 |
) |
|
|
(911 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
26,290 |
|
|
|
27,352 |
|
|
|
|
|
|
|
|
|
|
$ |
211,524 |
|
|
$ |
326,053 |
|
|
|
|
|
|
|
|
See accompanying notes.
3
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share data)
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Three Months |
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Nine Months |
|
|
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Ended September 30, |
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|
Ended September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties |
|
$ |
5,229 |
|
|
$ |
|
|
|
$ |
6,639 |
|
|
$ |
|
|
Collaborative research and development and
other revenues |
|
|
250 |
|
|
|
|
|
|
|
485 |
|
|
|
3,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
5,479 |
|
|
|
|
|
|
|
7,124 |
|
|
|
3,977 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
9,838 |
|
|
|
10,159 |
|
|
|
34,191 |
|
|
|
28,664 |
|
General and administrative |
|
|
4,856 |
|
|
|
12,293 |
|
|
|
26,539 |
|
|
|
30,137 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
14,694 |
|
|
|
22,452 |
|
|
|
60,730 |
|
|
|
58,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of deferred gain on sale leaseback |
|
|
491 |
|
|
|
|
|
|
|
1,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(8,724 |
) |
|
|
(22,452 |
) |
|
|
(52,133 |
) |
|
|
(54,824 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,546 |
|
|
|
577 |
|
|
|
7,359 |
|
|
|
1,737 |
|
Interest expense |
|
|
(143 |
) |
|
|
(378 |
) |
|
|
(603 |
) |
|
|
(1,026 |
) |
Other, net |
|
|
99 |
|
|
|
66 |
|
|
|
161 |
|
|
|
1,068 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income, net |
|
|
1,502 |
|
|
|
265 |
|
|
|
6,917 |
|
|
|
1,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(7,222 |
) |
|
|
(22,187 |
) |
|
|
(45,216 |
) |
|
|
(53,045 |
) |
Income tax benefit |
|
|
2,360 |
|
|
|
|
|
|
|
15,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
(4,862 |
) |
|
|
(22,187 |
) |
|
|
(29,437 |
) |
|
|
(53,045 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations
before income taxes |
|
|
|
|
|
|
7,284 |
|
|
|
5,993 |
|
|
|
(120,010 |
) |
Gain on sale of AVINZA Product Line before
income taxes |
|
|
6,892 |
|
|
|
|
|
|
|
317,306 |
|
|
|
|
|
Adjustment to gain on sale of Oncology
Product Line before income taxes |
|
|
(2,138 |
) |
|
|
|
|
|
|
7,669 |
|
|
|
|
|
Income tax benefit (expense) on
discontinued operations |
|
|
1,356 |
|
|
|
(17 |
) |
|
|
(25,781 |
) |
|
|
(52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Discontinued operations |
|
|
6,110 |
|
|
|
7,267 |
|
|
|
305,187 |
|
|
|
(120,062 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
1,248 |
|
|
$ |
(14,920 |
) |
|
$ |
275,750 |
|
|
$ |
(173,107 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
$ |
(0.05 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.68 |
) |
Discontinued operations |
|
|
0.06 |
|
|
|
0.09 |
|
|
|
3.08 |
|
|
|
(1.53 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
0.01 |
|
|
$ |
(0.19 |
) |
|
$ |
2.78 |
|
|
$ |
(2.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
96,541,752 |
|
|
|
78,670,137 |
|
|
|
99,020,141 |
|
|
|
78,239,868 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
4
LIGAND
PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine
Months Ended September 30, |
|
|
|
2007 |
|
|
2006 |
|
Operating activities: |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
275,750 |
|
|
$ |
(173,107 |
) |
Adjustments to reconcile income (loss) to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
Gain on sale of AVINZA Product Line before income taxes |
|
|
(317,306 |
) |
|
|
|
|
Adjustment to gain on sale of Oncology Product Line
before income taxes |
|
|
(7,669 |
) |
|
|
|
|
Accretion of deferred gain on sale leaseback |
|
|
(1,473 |
) |
|
|
|
|
Amortization of acquired technology and license rights |
|
|
909 |
|
|
|
10,248 |
|
Depreciation and amortization of property and equipment |
|
|
1,342 |
|
|
|
2,576 |
|
Loss on asset write-offs |
|
|
755 |
|
|
|
|
|
Amortization of debt discount and issuance costs |
|
|
|
|
|
|
705 |
|
Gain on sale of investment |
|
|
|
|
|
|
(953 |
) |
Stock-based compensation |
|
|
6,996 |
|
|
|
3,981 |
|
Non-cash co-promote termination expense |
|
|
(1,409 |
) |
|
|
|
|
Non-cash interest expense |
|
|
|
|
|
|
60 |
|
Other |
|
|
324 |
|
|
|
(16 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
11,523 |
|
|
|
13,877 |
|
Inventories, net |
|
|
930 |
|
|
|
(514 |
) |
Other current assets |
|
|
3,616 |
|
|
|
1,976 |
|
Restricted indemnity account |
|
|
(9,969 |
) |
|
|
|
|
Accounts payable and accrued liabilities |
|
|
(45,030 |
) |
|
|
(5,753 |
) |
Other liabilities |
|
|
428 |
|
|
|
(14 |
) |
Deferred revenue, net |
|
|
(8,657 |
) |
|
|
(50,498 |
) |
Co-promote termination liability |
|
|
|
|
|
|
142,980 |
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(88,940 |
) |
|
|
(54,452 |
) |
|
|
|
|
|
|
|
Investing activities: |
|
|
|
|
|
|
|
|
Proceeds from sale of AVINZA Product Line |
|
|
289,361 |
|
|
|
|
|
Additional proceeds from sale of Oncology Product Line |
|
|
10,000 |
|
|
|
|
|
Proceeds from sale of property and equipment |
|
|
311 |
|
|
|
|
|
Purchases of short-term investments |
|
|
(23,626 |
) |
|
|
(18,324 |
) |
Proceeds from sale of short-term investments |
|
|
7,982 |
|
|
|
16,963 |
|
Decrease in restricted cash and investments |
|
|
39,229 |
|
|
|
|
|
Purchases of property and equipment |
|
|
(369 |
) |
|
|
(1,592 |
) |
Other, net |
|
|
70 |
|
|
|
72 |
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
322,958 |
|
|
|
(2,881 |
) |
|
|
|
|
|
|
|
Financing activities: |
|
|
|
|
|
|
|
|
Principal payments on equipment financing obligations |
|
|
(1,625 |
) |
|
|
(2,012 |
) |
Proceeds from equipment financing arrangements |
|
|
|
|
|
|
1,030 |
|
Repayment of debt |
|
|
(37,750 |
) |
|
|
(255 |
) |
Proceeds from issuance of common stock |
|
|
4,349 |
|
|
|
1,981 |
|
Dividend paid |
|
|
(252,742 |
) |
|
|
|
|
Dividend received on treasury stock held by Company |
|
|
185 |
|
|
|
|
|
Repurchase of Company common stock |
|
|
(35,535 |
) |
|
|
|
|
Decrease in other long-term liabilities |
|
|
|
|
|
|
(138 |
) |
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(323,118 |
) |
|
|
606 |
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
|
|
(89,100 |
) |
|
|
(56,727 |
) |
Cash and cash equivalents at beginning of period |
|
|
158,401 |
|
|
|
66,756 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
69,301 |
|
|
$ |
10,029 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
1,280 |
|
|
$ |
5,283 |
|
|
|
|
|
|
|
|
Taxes paid |
|
$ |
6,296 |
|
|
$ |
|
|
|
|
|
|
|
|
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
|
|
|
Conversion of principal amount of convertible notes |
|
$ |
|
|
|
$ |
27,100 |
|
Conversion of unamortized debt issue costs |
|
|
|
|
|
|
(362 |
) |
Conversion of unpaid accrued interest |
|
|
|
|
|
|
264 |
|
See accompanying notes.
5
LIGAND PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Basis of Presentation
The accompanying condensed consolidated financial statements of Ligand Pharmaceuticals
Incorporated (the Company or Ligand) were prepared in accordance with instructions for this
Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and, therefore, do not
include all information necessary for a complete presentation of financial condition, results of
operations, and cash flows in conformity with accounting principles generally accepted in the
United States of America. However, all adjustments, consisting of normal recurring adjustments,
which, in the opinion of management, are necessary for a fair presentation of the condensed
consolidated financial statements, have been included. The results of operations for the three and
nine-month periods ended September 30, 2007 and 2006 are not necessarily indicative of the results
that may be expected for the entire fiscal year or any other future period. These statements
should be read in conjunction with the consolidated financial statements and related notes, which
are included in the Companys Annual Report on Form 10-K for the fiscal year ended December 31,
2006.
As further discussed in Note 2, the Company sold its oncology product line (Oncology) on
October 25, 2006 and its AVINZA product line (AVINZA) on February 26, 2007. The operating
results for Oncology and AVINZA have been presented in the accompanying condensed consolidated
financial statements as Discontinued Operations.
The Companys other potential products are in various stages of development. Potential
products that are promising at early stages of development may not reach the market for a number of
reasons. A significant portion of the Companys revenues to date have been derived from research
and development agreements with major pharmaceutical collaborators. Prior to generating revenues
from these products, the Company or its collaborators must complete the development of the products
in the human health care market. No assurance can be given that: (1) product development efforts
will be successful, (2) required regulatory approvals for any indication will be obtained, (3) any
products, if introduced, will be capable of being produced in commercial quantities at reasonable
costs or, (4) patient and physician acceptance of these products will be achieved. There can be no
assurance that the Company will ever achieve or sustain annual profitability.
The Company faces risks common to companies whose products are in various stages of
development. These risks include, among others, the Companys potential need for additional
financing to complete its research and development programs and commercialize its technologies.
The Company has incurred significant losses since its inception. At September 30, 2007, the
Companys accumulated deficit was $587.5 million. The Company expects to continue to incur
substantial research and development expenses.
The Company believes that patents and other proprietary rights are important to its business.
Its policy is to file patent applications to protect technology, inventions and improvements to its
inventions that are considered important to the development of its business. The patent positions
of pharmaceutical and biotechnology firms, including the Company, are uncertain and involve complex
legal and technical questions for which important legal principles are largely unresolved.
Principles of Consolidation
The condensed consolidated financial statements include the Companys wholly owned
subsidiaries, Ligand Pharmaceuticals International, Inc., Ligand Pharmaceuticals (Canada)
Incorporated, Seragen, Inc. (Seragen) and Nexus Equity VI LLC (Nexus). Intercompany accounts
and transactions have been eliminated in consolidation.
6
Use of Estimates
The preparation of consolidated financial statements in conformity with generally accepted
accounting principles requires the use of estimates and assumptions that affect the reported
amounts of assets and liabilities, including disclosure of contingent assets and contingent
liabilities, at the date of the consolidated financial statements, and the reported amounts of
revenue and expenses during the reporting period. The Companys critical accounting policies are
those that are both most important to the Companys financial condition and results of operations
and require the most difficult, subjective or complex judgments on the part of management in their
application, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain. Because of the uncertainty of factors surrounding the estimates or judgments
used in the preparation of the consolidated financial statements, actual results may materially
vary from these estimates.
Income (Loss) Per Share
Net income (loss) per share is computed using the weighted average number of common shares
outstanding. Basic and diluted income (loss) per share amounts are equivalent for the periods
presented as the inclusion of potential common shares in the number of shares used for the diluted
computation would be anti-dilutive to loss per share from continuing operations. In accordance
with Statement of Financial Accounting Standards (SFAS) No. 128, Earnings Per Share, no potential
common shares are included in the computation of any diluted per share amounts, including income
(loss) per share from discontinued operations and net income (loss) per share, as the Company
reported a loss from continuing operations for all periods presented. Potential common shares, the
shares that would be issued upon the conversion of convertible notes, the exercise of outstanding
warrants and stock options, and the vesting of restricted shares, were 3.9 million and 28.6 million
at September 30, 2007 and 2006, respectively. In October 2006, all outstanding warrants to
purchase shares of the Companys common stock expired. As of November 2006, all convertible notes
had been converted into shares of the Companys common stock.
Guarantees and Indemnifications
The Company accounts for and discloses guarantees in accordance with Financial Accounting
Standards Board (FASB) Interpretation No. 45 (FIN 45), Guarantors Accounting and Disclosure
Requirements for Guarantees Including Indirect Guarantees of Indebtedness of Others, an
interpretation of FASB Statements No. 5, 57 and 107 and rescission of FIN 34. The following is a
summary of the Companys agreements that the Company has determined are within the scope of FIN 45:
Under its bylaws, the Company has agreed to indemnify its officers and directors for certain
events or occurrences arising as a result of the officers or directors serving in such capacity.
The term of the indemnification period is for the officers or directors lifetime. The maximum
potential amount of future payments the Company could be required to make under these
indemnification agreements is unlimited. The Company has a directors and officers liability
insurance policy that limits its exposure and enables it to recover a portion of any future amounts
paid. As a result of its insurance policy coverage, the Company believes that the estimated fair
value of these indemnification agreements is minimal and has no liabilities recorded for these
agreements as of September 30, 2007 and December 31, 2006. These insurance policies, however, do
not cover the ongoing legal costs or the fines, if any, that may become due in connection with the
ongoing SEC investigation of the Company, following the use of prior directors and officers
liability insurance policy limits to settle certain shareholder litigation matters. The SEC
investigation is ongoing, and the Company is currently unable to assess the duration, extent, and
cost of such investigation. Further, the Company is unable to assess the amount of such costs that
may in turn be required to be reimbursed to any individual director or officer under the Companys
indemnification agreements as the scope of the investigation cannot be apportioned amongst the
Company and the indemnified officers and directors. Accordingly, a liability has not been recorded
for the fair value of the ongoing and ultimate obligations, if any, related to the SEC
investigation.
On March 1, 2007, the Company entered into an indemnity fund agreement, which established in a
trust account with Dorsey & Whitney LLP, counsel to the Companys independent directors and to the
Audit Committee of the Companys Board of Directors, a $10.0 million indemnity fund to support the
Companys existing indemnification
7
obligations to continuing and departing directors in connection with the ongoing SEC
investigation and related matters. The balance of this fund, amounting to $10.0 million, has been
recorded as restricted indemnification account on the condensed consolidated balance sheet as of
September 30, 2007 (see Note 12).
The Company may enter into other indemnification provisions under its agreements with other
companies in its ordinary course of business, typically with business partners, suppliers,
contractors, customers and landlords. Under these provisions the Company generally indemnifies and
holds harmless the indemnified party for direct losses suffered or incurred by the indemnified
party as a result of the Companys activities or, in some cases, as a result of the indemnified
partys activities under the agreement. The maximum potential amount of future payments the
Company could be required to make under these indemnification provisions is unlimited. The Company
has not incurred material costs to defend lawsuits or settle claims related to these
indemnification agreements. As a result, the Company believes the estimated fair value of these
agreements is minimal. Accordingly, the Company has no liabilities recorded for these agreements
as of September 30, 2007 and December 31, 2006.
Revenue Recognition AVINZA Royalties
In accordance with the AVINZA Purchase Agreement (see Note 2), royalties are required to be
reported and paid to the Company within 45 days of quarter-end during the 20 month period following
the closing of the sale transaction. Thereafter, royalties will be paid on a calendar year basis.
Royalties on sales of AVINZA due from King are recognized in the quarter reported by King. Since
there is a one quarter lag from when King recognizes AVINZA net sales to when King reports those
sales and the corresponding royalties to the Company, the Company recognized AVINZA royalty
revenues beginning in the second quarter of 2007.
Accounting for Stock-Based Compensation
Effective January 1, 2006, the Company adopted SFAS No. 123 (revised 2004), Share-Based
Payment (SFAS 123(R)), using the modified prospective transition method. No stock-based employee
compensation cost was recognized prior to January 1, 2006, as all options granted prior to 2006 had
an exercise price equal to the market value of the underlying common stock on the date of the
grant. In March 2005, the Securities and Exchange Commission issued Staff Accounting Bulletin
(SAB) No. 107 (SAB 107) relating to SFAS 123(R). The Company has applied the provisions of SAB
107 in its adoption of SFAS 123(R). Under the transition method, compensation cost recognized in
2007 and 2006 includes: (a) compensation cost for all share-based payments granted prior to, but
not yet vested as of January 1, 2006, based on the grant date fair value estimated in accordance
with the original provisions of SFAS 123, and (b) compensation cost for all share-based payments
granted on or after January 1, 2006, based on grant-date fair value estimated in accordance with
the provisions of SFAS 123(R).
Additionally, the Company accounts for the fair value of options granted to non-employee
consultants under Emerging Issues Task Force 96-18, Accounting for Equity Instruments That Are
Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.
Other Stock-Related Information
The 2002 Stock Incentive Plan contains five separate equity programs Discretionary Option
Grant Program, Automatic Option Grant Program, Stock Issuance Program, Director Fee Option Grant
Program and Other Stock Award Program (the 2002 Plan). On May 31, 2007, shareholders of the
Company approved an amendment and restatement of the 2002 Plan. As of September 30, 2007, options
for 3,554,549 shares of common stock were outstanding under the 2002 plan and 2,088,049 shares
remained available for future option grant or direct issuance.
The Company grants options to employees, non-employee consultants, and non-employee directors.
Non-employee directors are accounted for as employees under SFAS 123(R). Options and restricted
stock granted to certain directors generally vest in equal monthly installments over one year from
the date of grant. Options granted to employees generally vest 1/8 on the six month anniversary of
the date of grant, and 1/48 each month thereafter for forty-two months. Restricted stock awards
granted to employees generally vest over three years from the date of grant. However, restricted
stock awards granted to employees on June 20, 2007, vest on the later of February 15, 2008 or three
days following the announcement of 2007 year end financial results and one-third vesting on each
8
anniversary date thereafter. Options granted to non-employee consultants generally vest
between 24 and 36 months from the date of grant. All option awards generally expire ten years from
the date of grant.
Stock-based compensation cost for awards to employees and non-employee directors is recognized
on a straight-line basis over the vesting period until the last tranche vests. Compensation cost
for consultant awards is recognized over each separate tranches vesting period. The Company
recognized compensation expense of approximately $0.9 million and $1.9 million for the three months
ended September 30, 2007 and 2006, respectively, and $7.0 million and $4.0 million for the nine
months ended September 30, 2007 and 2006, respectively, associated with option awards, restricted
stock and an equitable adjustment of employee stock options. Of the total compensation expense
associated with option awards, zero and $0.1 million related to options granted to non-employee
consultants for the three months ended September 30, 2007 and 2006, respectively, and zero and $0.3
million related to options granted to non-employee consultants for the nine months ended September
30, 2007 and 2006, respectively. Of the total compensation expense associated with the option
awards for the three and nine months ended September 30, 2007, $0.01 million and $1.8 million,
respectively, related to the $2.50 equitable adjustment of the exercise price for all options
outstanding as of April 3, 2007 that was measured for financial reporting purposes effective March
28, 2007, the date the Compensation Committee of the Companys Board of Directors approved the
adjustment (see Note 13). There was no deferred tax benefit recognized in connection with these
costs.
The fair-value for options that were awarded to employees and directors was estimated at the
date of grant using the Black-Scholes option valuation model with the following weighted-average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
Risk-free interest rate |
|
|
4.4 |
% |
|
|
4.8 |
% |
|
|
4.9 |
% |
|
|
4.8 |
% |
Dividend yield |
|
|
|
|
|
|
¾ |
|
|
|
|
|
|
|
¾ |
|
Expected volatility |
|
|
65 |
% |
|
|
70 |
% |
|
|
66 |
% |
|
|
70 |
% |
Expected term |
|
|
6.0 |
years |
|
|
5.7 |
years |
|
|
6.0 |
years |
|
|
5.9 |
years |
The expected term of the employee and non-employee director options is the estimated
weighted-average period until exercise or cancellation of vested options (forfeited unvested
options are not considered). SAB 107 guidance permits companies to use a safe harbor expected
term assumption for grants up to December 31, 2007 based on the mid-point of the period between
vesting date and contractual term, averaged on a tranche-by-tranche basis. The Company used the
safe harbor in selecting the expected term assumption in 2007 and 2006. The expected term for
consultant awards is the remaining period to contractual expiration.
Volatility is a measure of the expected amount of variability in the stock price over the
expected life of an option expressed as a standard deviation. SFAS 123(R) requires an estimate of
future volatility. In selecting this assumption, the Company used the historical volatility of the
Companys stock price over a period approximating the expected term.
9
Stock Option Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Contractual Term |
|
|
Intrinsic Value |
|
|
|
Shares |
|
|
Price |
|
|
in Years |
|
|
(in thousands) |
|
Balance at December 31, 2006 |
|
|
5,766,386 |
|
|
$ |
10.43 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
780,936 |
|
|
|
7.23 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(601,127 |
) |
|
|
7.03 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(480,388 |
) |
|
|
8.50 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(1,911,258 |
) |
|
|
12.44 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30,
2007 |
|
|
3,554,549 |
|
|
$ |
9.42 |
|
|
|
4.04 |
|
|
$ |
405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at September
30, 2007 |
|
|
2,644,229 |
|
|
$ |
10.13 |
|
|
|
2.20 |
|
|
$ |
373 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options expected to vest as
of September 30, 2007 |
|
|
3,474,225 |
|
|
$ |
9.44 |
|
|
|
3.93 |
|
|
$ |
405 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of all stock options granted during the nine months
ended September 30, 2007 was $4.89 per share. The total intrinsic value of all options exercised
during the nine months ended September 30, 2007 was $1.7 million. As of September 30, 2007, there
was approximately $3.9 million of total unrecognized compensation cost related to nonvested stock
options. That cost is expected to be recognized over a weighted average period of 2.87 years.
Cash received from options exercised for the nine months ended September 30, 2007 and 2006 was
approximately $4.2 million and $1.9 million, respectively. There is no current tax benefit related
to options exercised because of net operating losses (NOLs) for which a full valuation allowance
has been established.
Restricted Stock Activity
Restricted stock activity for the nine months ended September 30, 2007 follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average Stock |
|
|
|
Shares |
|
|
Price |
|
Balance at December 31, 2006 |
|
|
1,297 |
|
|
$ |
11.56 |
|
Granted |
|
|
320,300 |
|
|
|
9.69 |
|
Vested |
|
|
(1,297 |
) |
|
|
11.56 |
|
Forfeited |
|
|
(6,350 |
) |
|
|
7.15 |
|
|
|
|
|
|
|
|
Nonvested at September 30, 2007 |
|
|
313,950 |
|
|
$ |
9.74 |
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of restricted stock granted during the nine months
ended September 30, 2007 was $9.69 per share. As of September 30, 2007, there was $2.3 million of
total unrecognized compensation cost related to nonvested restricted stock. That cost is expected
to be recognized over the weighted average period of 1.87 years.
10
Employee Stock Purchase Plan
The Company also has an employee stock purchase plan (the 2002 ESPP). The 2002 ESPP was
originally adopted July 1, 2001 and amended through June 30, 2003 to allow employees to purchase a
limited amount of common stock at the end of each three month period at a price equal to the lesser
of 85% of fair market value on a) the first trading day of the period, or b) the last trading day
of the Lookback period (the Lookback Provision). The 15% discount and the Lookback Provision
make the 2002 ESPP compensatory under SFAS 123(R). There were 20,110 shares of common stock issued
under the 2002 ESPP during the nine months ended September 30, 2007, resulting in an expense of
$0.03 million. There were 14,199 shares of common stock issued under the 2002 ESPP during the nine
months ended September 30, 2006, resulting in an expense of $0.03 million. As of September 30,
2007, 407,611 shares of common stock had been issued under the 2002 ESPP to employees and 102,637
shares are available for future issuance.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and highly liquid securities with maturities at the
date of acquisition of three months or less.
On July 19, 2007, the Company purchased $5.0 million of commercial paper issued by Golden Key
Ltd. As this security had a stated maturity date of October 10,
2007, the Company had classified
the security as a cash equivalent. During the third quarter of 2007, large credit rating agencies
downgraded the quality of this security. In addition, as a result of not meeting certain liquidity
covenants, the assets were assigned to a trustee who established a committee of the largest senior
credit holders to determine the next steps. Subsequently, Golden Key defaulted on its obligation
to settle the security on the stated maturity date of October 10, 2007. The Company does not have
any further information as to the expected resolution of this matter and cannot estimate at this
time, neither as a point estimate nor a range, the loss in value, if any, of this security.
Accordingly, this security is carried at its estimated fair value of $5.0 million on the balance
sheet at September 30, 2007.
Short-term and Restricted Investments
The following table summarizes the various investment categories at September 30, 2007 and
December 31, 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
unrealized |
|
|
unrealized |
|
|
Estimated |
|
|
|
Cost |
|
|
gains |
|
|
losses |
|
|
Fair Value |
|
September 30, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities |
|
$ |
22,293 |
|
|
$ |
18 |
|
|
$ |
¾ |
|
|
$ |
22,311 |
|
Corporate obligations |
|
|
6,769 |
|
|
|
11 |
|
|
|
¾ |
|
|
|
6,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,062 |
|
|
|
29 |
|
|
|
¾ |
|
|
|
29,091 |
|
Certificates
of deposit - restricted |
|
|
1,411 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
1,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt securities |
|
$ |
30,473 |
|
|
$ |
29 |
|
|
$ |
¾ |
|
|
$ |
30,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities |
|
$ |
2,750 |
|
|
$ |
¾ |
|
|
$ |
(4 |
) |
|
$ |
2,746 |
|
Corporate obligations |
|
|
10,681 |
|
|
|
23 |
|
|
|
(3 |
) |
|
|
10,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,431 |
|
|
|
23 |
|
|
|
(7 |
) |
|
|
13,447 |
|
Certificates of deposit restricted |
|
|
1,826 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
1,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt securities |
|
$ |
15,257 |
|
|
$ |
23 |
|
|
$ |
(7 |
) |
|
$ |
15,273 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
Inventories
Inventories are stated at the lower of cost or market. Cost is determined using the first-in,
first-out method. Inventories consist of the following (in thousands):
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
Work-in-process |
|
$ |
1,041 |
|
Finished goods |
|
|
2,968 |
|
Less: inventory reserves |
|
|
(153 |
) |
|
|
|
|
|
|
$ |
3,856 |
|
|
|
|
|
Inventories, net as of December 31, 2006 is comprised of AVINZA Product Line inventory which
was sold in connection with the sale of the AVINZA Product Line on February 26, 2007 (see Note 2).
Other Current Assets
Other current assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Prepaid expenses |
|
$ |
1,914 |
|
|
$ |
1,442 |
|
Other receivables |
|
|
623 |
|
|
|
4,066 |
|
Deferred cost of products sold |
|
|
|
|
|
|
2,153 |
|
Deferred royalty cost |
|
|
|
|
|
|
1,785 |
|
Other |
|
|
92 |
|
|
|
72 |
|
|
|
|
|
|
|
|
|
|
$ |
2,629 |
|
|
$ |
9,518 |
|
|
|
|
|
|
|
|
Deferred royalty cost and deferred cost of products sold as of December 31, 2006 pertain to
the AVINZA Product Line which was sold on February 26, 2007 (see Note 2).
Property and Equipment
Property and equipment is stated at cost and consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Equipment and leasehold improvements |
|
$ |
40,930 |
|
|
$ |
45,835 |
|
Less accumulated depreciation and amortization |
|
|
(37,496 |
) |
|
|
(40,284 |
) |
|
|
|
|
|
|
|
|
|
$ |
3,434 |
|
|
$ |
5,551 |
|
|
|
|
|
|
|
|
Depreciation of equipment is computed using the straight-line method over the estimated useful
lives of the assets which range from three to ten years. Leasehold improvements are amortized
using the straight-line method over their estimated useful lives or their related lease term,
whichever is shorter.
The Companys corporate headquarter building, which was sold on November 9, 2006 (see Note 6),
had been depreciated over its estimated useful life of thirty years.
12
Acquired Technology and Product Rights
In accordance with SFAS No. 142, Goodwill and Other Intangibles, the Company amortizes
intangible assets with finite lives in a manner that reflects the pattern in which the economic
benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably
determined, the assets are amortized using the straight-line method.
Acquired technology and product rights, net consist of the following (in thousands):
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
AVINZA |
|
$ |
114,437 |
|
Less accumulated amortization |
|
|
(31,354 |
) |
|
|
|
|
|
|
$ |
83,083 |
|
|
|
|
|
Amortization of acquired technology and product rights, net was zero and $3.1 million for the
three months ended September 30, 2007 and 2006, respectively, and $0.9 million and $10.1 million
for the nine months ended September 30, 2007 and 2006, respectively. These amounts are included in
results of discontinued operations for the applicable periods. Acquired technology and product
rights related to the Oncology Product Line were sold effective October 25, 2006 as part of the
sale of the Companys Oncology Product Line (see Note 2). Additionally, the AVINZA assets were
sold effective February 26, 2007 as part of the sale of the Companys AVINZA Product Line (see Note
2).
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment annually or whenever events or changes in
circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of
assets to be held and used is measured by a comparison of the carrying amount of an asset to future
undiscounted net cash flows expected to be generated by the asset. If such assets are considered
to be impaired, the impairment to be recognized is measured as the amount by which the carrying
amount of the assets exceeds the fair value of the assets. Fair value for the Companys long-lived
assets is determined using the expected cash flows discounted at a rate commensurate with the risk
involved. During the three months ended June 30, 2007, the Company recorded a $0.3 million
reduction to its first quarter 2007 impairment charge of $1.1 million which primarily reflects
proceeds received from the sale of the assets. The net $0.8 million ($0.3 million to research and
development expenses and $0.5 million to general and administrative expenses) impairment charge for
the nine months ended September 30, 2007 reflects the abandonment or disposal of certain equipment
items that are no longer used in the Companys ongoing operations following the sale of the
Companys AVINZA product line (see Note 2) and the reduction in workforce (see Note 11). As
of September 30, 2007, the Company believes that the future cash flows to be received from its
long-lived assets will exceed the assets carrying value.
Deferred Revenue
Under the sell-through revenue recognition method, the Company did not recognize revenue upon
shipment of product to the wholesaler. For these shipments, the Company invoiced the wholesaler,
recorded deferred revenue at gross invoice sales price, and classified the inventory held by the
wholesaler (and subsequently held by retail pharmacies as in the case of AVINZA) as deferred cost
of goods sold within other current assets. Deferred revenue is presented net of deferred cash
and other discounts. Other deferred revenue reflects the sale of certain royalty rights.
13
The composition of deferred revenue, net is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Deferred product revenue (net), current |
|
$ |
|
|
|
$ |
57,981 |
|
Other deferred revenue (net), long term |
|
|
2,546 |
|
|
|
2,546 |
|
|
|
|
|
|
|
|
|
|
$ |
2,546 |
|
|
$ |
60,527 |
|
|
|
|
|
|
|
|
Deferred product revenue as of December 31, 2006 pertains to the AVINZA Product Line which was
sold on February 26, 2007 (see Note 2).
Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Allowances for loss on returns, rebates,
chargebacks, and other discounts |
|
$ |
18,377 |
|
|
$ |
14,688 |
|
Income taxes |
|
|
4,119 |
|
|
|
822 |
|
Compensation |
|
|
2,199 |
|
|
|
9,330 |
|
Co-promotion |
|
|
1,753 |
|
|
|
14,265 |
|
Distribution services |
|
|
43 |
|
|
|
2,641 |
|
Interest |
|
|
|
|
|
|
776 |
|
Other |
|
|
4,379 |
|
|
|
3,987 |
|
|
|
|
|
|
|
|
|
|
$ |
30,870 |
|
|
$ |
46,509 |
|
|
|
|
|
|
|
|
14
The following summarizes the activity in the accrued liability accounts related to allowances
for loss on returns, rebates, chargebacks, and other discounts for the nine months ended September
30, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rebates and |
|
|
|
|
|
|
|
|
|
|
|
|
Medicaid |
|
|
Other |
|
|
Charge- |
|
|
|
|
|
|
|
|
|
Rebates |
|
|
Rebates |
|
|
backs |
|
|
Returns |
|
|
Total |
|
Balance at December
31, 2006 |
|
$ |
1,406 |
|
|
$ |
3,561 |
|
|
$ |
1,280 |
|
|
$ |
8,441 |
|
|
$ |
14,688 |
|
Provision |
|
|
952 |
|
|
|
2,768 |
|
|
|
209 |
|
|
|
(1,114 |
)(3) |
|
|
2,815 |
|
AVINZA Transaction
Provision (1) |
|
|
513 |
|
|
|
1,382 |
|
|
|
58 |
|
|
|
17,172 |
|
|
|
19,125 |
|
Oncology Transaction
Provision (2) |
|
|
145 |
|
|
|
¾ |
|
|
|
87 |
|
|
|
3,940 |
|
|
|
4,172 |
|
Payments |
|
|
(2,614 |
) |
|
|
(6,474 |
) |
|
|
(443 |
) |
|
|
¾ |
|
|
|
(9,531 |
) |
Charges |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(12,892 |
) |
|
|
(12,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
September 30, 2007 |
|
$ |
402 |
|
|
$ |
1,237 |
|
|
$ |
1,191 |
|
|
$ |
15,547 |
|
|
$ |
18,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The AVINZA transaction provision amounts represent additional accruals recorded in
connection with the sale of the AVINZA Product Line to King Pharmaceuticals, Inc. on February
26, 2007. The Company will maintain the obligation for returns of product that were shipped
to wholesalers prior to the close of the King transaction on February 26, 2007 and chargebacks
and rebates associated with product in the distribution channel as of the closing date. See
Note 2 for additional information. |
|
(2) |
|
The Oncology transaction provision amounts represent changes in the estimates of the
accruals for chargebacks and rebates recorded in connection with the sale of the Oncology
Product Line to Eisai Pharmaceuticals, Inc. on October 25, 2006. See Note 2 for additional
information. |
|
(3) |
|
The credit for returns in 2007 primarily consists of a change in the estimate of
ONTAK end-customer returns. The accrual for ONTAK end-customer returns is a result of the
operations of the Oncology Product Line prior to its sale on October 25, 2006. |
15
Condensed Changes in Stockholders Equity
Condensed changes in stockholders equity for the nine months ended September 30, 2007 are as
follows (in thousands, except share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Accumulated other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
paid-in |
|
|
comprehensive |
|
|
Accumulated |
|
|
Treasury Stock |
|
|
stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
capital |
|
|
loss |
|
|
deficit |
|
|
Shares |
|
|
Amount |
|
|
equity |
|
Balance at December 31, 2006 |
|
|
99,553,504 |
|
|
$ |
100 |
|
|
$ |
891,446 |
|
|
$ |
(481 |
) |
|
$ |
(862,802 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
27,352 |
|
Effect of adopting FIN 48
(see Note 14) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(398 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
(398 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2007 |
|
|
99,553,504 |
|
|
|
100 |
|
|
|
891,446 |
|
|
|
(481 |
) |
|
|
(863,200 |
) |
|
|
(73,842 |
) |
|
|
(911 |
) |
|
|
26,954 |
|
Issuance of common stock
under employee stock
compensation plans |
|
|
771,237 |
|
|
|
¾ |
|
|
|
4,311 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
4,311 |
|
Repurchase of Company common
stock |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(5,406,791 |
) |
|
|
(35,535 |
) |
|
|
(35,535 |
) |
Unrealized net gain on
available
-for-sale securities |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
34 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
34 |
|
Foreign currency translation
adjustments |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
337 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
337 |
|
Stock-based compensation |
|
|
¾ |
|
|
|
¾ |
|
|
|
6,996 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
6,996 |
|
Net income |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
275,750 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
275,750 |
|
Dividend received on
treasury stock held by
Company |
|
|
¾ |
|
|
|
¾ |
|
|
|
185 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
185 |
|
Cash dividend paid |
|
|
¾ |
|
|
|
¾ |
|
|
|
(252,742 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
(252,742 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
|
100,324,741 |
|
|
$ |
100 |
|
|
$ |
650,196 |
|
|
$ |
(110 |
) |
|
$ |
(587,450 |
) |
|
|
(5,480,633 |
) |
|
$ |
(36,446 |
) |
|
$ |
26,290 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Income (Loss)
Comprehensive income (loss) represents net income (loss) adjusted for the change during the
periods presented in unrealized gains and losses on available-for-sale securities less
reclassification adjustments for realized gains or losses included in net income (loss), as well as
foreign currency translation adjustments. The accumulated unrealized gains or losses and
cumulative foreign currency translation adjustments are reported as accumulated other comprehensive
loss as a separate component of stockholders equity. Comprehensive income (loss) is as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Net income (loss) as reported |
|
$ |
1,248 |
|
|
$ |
(14,920 |
) |
|
$ |
275,750 |
|
|
$ |
(173,107 |
) |
Unrealized net gain (loss) on
available-for-sale securities |
|
|
40 |
|
|
|
(168 |
) |
|
|
34 |
|
|
|
(613 |
) |
Foreign currency translation
adjustments |
|
|
5 |
|
|
|
¾ |
|
|
|
337 |
|
|
|
(15 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) |
|
$ |
1,293 |
|
|
$ |
(15,088 |
) |
|
$ |
276,121 |
|
|
$ |
(173,735 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
16
The components of accumulated other comprehensive loss are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Unrealized net holding gain (loss) on
available-for-sale
securities |
|
$ |
29 |
|
|
$ |
(5 |
) |
Unrealized net loss on foreign currency
translation |
|
|
(139 |
) |
|
|
(476 |
) |
|
|
|
|
|
|
|
|
|
$ |
(110 |
) |
|
$ |
(481 |
) |
|
|
|
|
|
|
|
Collaborative Research and Development and Other Revenues
Collaborative research and development and other revenues are recognized as services are
performed consistent with the performance requirements of the contract. Non-refundable contract
fees for which no further performance obligation exists and where the Company has no continuing
involvement are recognized upon the earlier of when payment is received or collection is assured.
Revenue from non-refundable contract fees where the Company has continuing involvement through
research and development collaborations or other contractual obligations is recognized ratably over
the development period or the period for which the Company continues to have a performance
obligation. Revenue from performance milestones is recognized upon the achievement of the
milestones as specified in the respective agreement. Payments received in advance of performance
or delivery are recorded as deferred revenue and subsequently recognized over the period of
performance or upon delivery.
The composition of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Collaborative research and development |
|
$ |
¾ |
|
|
$ |
¾ |
|
|
$ |
¾ |
|
|
$ |
1,678 |
|
Development milestones and other |
|
|
250 |
|
|
|
¾ |
|
|
|
485 |
|
|
|
2,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
250 |
|
|
$ |
¾ |
|
|
$ |
485 |
|
|
$ |
3,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income Taxes
The Company recognizes liabilities or assets for the deferred tax consequences of temporary
differences between the tax bases of assets or liabilities and their reported amounts in the
financial statements in accordance with SFAS No. 109, Accounting for Income Taxes (SFAS 109).
These temporary differences will result in taxable or deductible amounts in future years when the
reported amounts of the assets or liabilities are recovered or settled. SFAS 109 requires that a
valuation allowance be established when management determines that it is more likely than not that
all or a portion of a deferred tax asset will not be realized. The Company evaluates the
realizability of its net deferred tax assets on a quarterly basis and valuation allowances are
provided, as necessary. During this evaluation, the Company reviews its forecasts of income in
conjunction with other positive and negative evidence surrounding the realizability of its deferred
tax assets to determine if a valuation allowance is required. Adjustments to the valuation
allowance will increase or decrease the Companys income tax provision or benefit. The Company
also applies the guidance of SFAS 109 to determine the amount of income tax expense or benefit to
be allocated among continuing operations, discontinued operations, and items charged or credited
directly to stockholders equity.
Due to the adoption of SFAS 123(R) beginning January 1, 2006, the Company recognizes windfall
tax benefits associated with the exercise of stock options directly to stockholders equity only
when realized. Accordingly, deferred tax assets are not recognized for net operating loss
carryforwards resulting from windfall tax benefits occurring from January 1, 2006 onward. A
windfall tax benefit occurs when the actual tax benefit realized by the Company upon an employees
disposition of a share-based award exceeds the deferred tax asset, if any, associated
17
with the award that the Company had recorded. When assessing whether a tax benefit relating to
share-based compensation has been realized, the Company follows the with-and-without method,
excluding the indirect effects, under which current year share-based compensation deductions are
assumed to be utilized after net operating loss carryforwards and other tax attributes.
As discussed in Note 14, effective January 1, 2007 the Company adopted FASB Interpretation No.
48, Accounting for Uncertainty in Income Taxes an interpretation of FASB Statement No. 109
(FIN48).
2. Discontinued Operations
Oncology Product Line
On September 7, 2006, the Company, Eisai Inc., a Delaware corporation and Eisai Co., Ltd., a
Japanese company (together with Eisai Inc., Eisai), entered into a purchase agreement (the
Oncology Purchase Agreement) pursuant to which Eisai agreed to acquire all of the Companys
worldwide rights in and to the Companys oncology products, including, among other things, all
related inventory, equipment, records and intellectual property, and assume certain liabilities
(the Oncology Product Line) as set forth in the Oncology Purchase Agreement. The Oncology Product
Line included the Companys four marketed oncology drugs: ONTAK, Targretin capsules, Targretin gel
and Panretin gel. Pursuant to the Oncology Purchase Agreement, at closing on October 25, 2006,
Ligand received approximately $185.0 million in net cash proceeds, net of $20.0 million that was
funded into an escrow account to support any indemnification claims made by Eisai following the
closing of the sale as further discussed below. Eisai also assumed certain liabilities. The
Company also incurred approximately $1.7 million in transaction fees and costs associated with the
sale that are not reflected in net cash proceeds. The Company recorded a pre-tax gain on the sale
of $135.8 million in the fourth quarter of 2006. In the first quarter of 2007, the Company recorded
a $0.1 million pre-tax reduction to the gain on the sale due to subsequent changes in certain
estimates of assets and liabilities recorded as of the sale date. In the second quarter of 2007,
the Company recognized a $10.0 million pre-tax gain resulting from the release of funds from the
escrow account partially offset by a $0.1 million pre-tax loss due to subsequent changes in certain
estimates of assets and liabilities recorded as of the sale date. In the third quarter of 2007,
the Company recorded a $2.1 million pre-tax reduction to the gain on the sale due to subsequent
changes in certain estimates of assets and liabilities recorded as of the sale date.
Additionally, $38.6 million of the proceeds received from Eisai were deposited into an escrow
account to repay a loan received from King Pharmaceuticals, Inc. (King), the proceeds of which
were used to pay the Companys co-promote termination obligation to Organon in October 2006. The
escrow amounts were released and the loan repaid to King in January 2007.
In connection with the Oncology Purchase Agreement with Eisai, the Company entered into a
transition services agreement whereby the Company agreed to perform certain transition services for
Eisai, in order to effect, as rapidly as practicable, the transition of purchased assets from
Ligand to Eisai. In exchange for these services, Eisai paid the Company a monthly service fee
through June 25, 2007. Fees earned under the transition services agreement during the three and
nine months ended September 30, 2007, which were recorded as an offset to operating expenses, were
zero and $2.7 million, respectively.
The Company agreed to indemnify Eisai, after the closing, for damages suffered by Eisai
arising from any breach of any of the representations, warranties, covenants or obligations the
Company made in the Oncology Purchase Agreement. The Companys obligation to indemnify Eisai
survives the closing in some cases up to 18 or 36 months following the closing, and in other cases,
until the expiration of the applicable statute of limitations. In a few instances, the Companys
obligation to indemnify Eisai survives in perpetuity. The Companys agreement with Eisai required
that $20.0 million of the total upfront cash payment be deposited into an escrow account to secure
the Companys indemnification obligations to Eisai after the closing. Of the escrowed amounts,
$10.0 million was released to the Company on April 25, 2007, and the remaining $10.0 million, plus
interest of approximately $0.8 million, was released to the Company on October 25, 2007. The
Companys liability for any indemnification claim brought by Eisai is generally limited to $30.0
million. However, the Companys obligation to provide indemnification on certain matters is not
subject to these indemnification limits. For example, the Company agreed to retain, and provide
indemnification without limitation to Eisai for, all liabilities related to certain claims
regarding
18
promotional materials for the ONTAK and Targretin drug products. The Company cannot estimate
the liabilities that may arise as a result of these matters.
Prior to the Oncology sale, the Company recorded accruals for rebates, chargebacks, and other
discounts related to Oncology products when product sales were recognized as revenue under the
sell-through method. Upon the Oncology sale, the Company accrued for rebates, chargebacks, and
other discounts related to Oncology products in the distribution channel which had not sold-through
at the time of the Oncology sale and for which the Company retained the liability subsequent to the
Oncology sale. The Companys accruals for Oncology rebates, chargebacks, and other discounts total
$1.1 million as of September 30, 2007 and are included in accrued liabilities in the accompanying
condensed consolidated balance sheet.
Additionally, and pursuant to the terms of the Oncology Purchase Agreement, the Company
retained the liability for returns of product from wholesalers that had been sold by the Company
prior to the close of the transaction. Accordingly, as part of the accounting for the gain on the
sale of the Oncology Product Line, the Company recorded a reserve for Oncology product returns.
Under the sell-through revenue recognition method, the Company previously did not record a reserve
for returns from wholesalers. The Companys reserve for Oncology returns is $5.4 million as of
September 30, 2007 and is included in accrued liabilities in the accompanying condensed
consolidated balance sheet.
AVINZA Product Line
On September 6, 2006, Ligand and King Pharmaceuticals, Inc. (King), entered into a purchase
agreement (the AVINZA Purchase Agreement), pursuant to which King agreed to acquire all of the
Companys rights in and to AVINZA in the United States, its territories and Canada, including,
among other things, all AVINZA inventory, records and related intellectual property, and assume
certain liabilities as set forth in the AVINZA Purchase Agreement (collectively, the
Transaction). In addition, King, subject to the terms and conditions of the AVINZA Purchase
Agreement, agreed to offer employment following the closing of the Transaction (the Closing) to
certain of the Companys existing AVINZA sales representatives or otherwise reimburse the Company
for agreed upon severance arrangements offered to any such non-hired representatives.
Pursuant to the AVINZA Purchase Agreement, at Closing on February 26, 2007 (the Closing
Date), the Company received $280.4 million in net cash proceeds, which is net of $15.0 million
that was funded into an escrow account to support potential indemnification claims made by King
following the Closing. The purchase price reflected a reduction of $12.7 million due to the
preliminary estimate of retail inventory levels of AVINZA at the Closing Date exceeding targeted
levels. After final studies and review by King, the final retail inventory-level adjustment was
determined to be $11.2 million. The Company received the additional $1.5 million in proceeds in
April 2007. The purchase price also reflects a reduction of $6.0 million for anticipated higher
cost of goods for King related to the Catalent Pharma Solutions (formerly Cardinal Health PTS,
LLC), or Catalent, manufacturing and packaging agreement. At the closing, Ligand agreed to not
assign the Catalent agreement to King, wind down the contract, and remain responsible for any
resulting liabilities. Subsequent to the closing, on April 30, 2007, the Company entered into a
letter agreement with Catalent which terminated, without penalty to either party, the manufacturing
and packaging agreement and certain related quality agreements with Catalent. In connection with
the termination, the Company and Catalent agreed that certain provisions of the manufacturing and
packaging agreement would survive and Catalent would continue to perform limited services.
Catalent will also continue to manufacture LGD-4665 capsules for the Company under the terms of a
separate agreement. The letter agreement with Catalent also contained a mutual general release of
all claims arising from or related to the manufacturing and packaging agreement. The Company paid
$0.3 million to a former executive in connection with the negotiation of the termination of the
Catalent manufacturing and packaging agreement. The Company does not expect the costs of winding
down the Catalent agreement to be material.
19
The net cash received also includes reimbursement of $47.8 million for co-promote termination
payments which had previously been paid to Organon, $0.9 million of interest Ligand paid King on a
loan that was repaid in January 2007, and $0.5 million of severance expense for AVINZA sales
representatives not offered positions with King. A summary of the net cash proceeds, exclusive of
$6.6 million in transaction costs and adjusted to reflect the final results of the retail inventory
study, is as follows (in thousands):
|
|
|
|
|
Purchase price |
|
$ |
265,000 |
|
Reimbursement of Organon payments |
|
|
47,750 |
|
Repayment of interest on King loan |
|
|
883 |
|
Reimbursement of sales representative severance costs |
|
|
453 |
|
|
|
|
|
|
|
|
314,086 |
|
|
|
|
|
|
Less retail pharmacy inventory adjustment |
|
|
(11,225 |
) |
Less cost of goods manufacturing adjustment |
|
|
(6,000 |
) |
|
|
|
|
|
|
|
296,861 |
|
|
|
|
|
|
Less funds placed into escrow |
|
|
(15,000 |
) |
Add funds released from escrow |
|
|
7,500 |
|
|
|
|
|
|
|
|
|
|
Net cash proceeds |
|
$ |
289,361 |
|
|
|
|
|
King also assumed Ligands co-promote termination obligation to make payments to Organon based
on net sales of AVINZA (approximately $93.2 million as of February 26, 2007). As Organon has not
consented to the legal assignment of the co-promote termination obligation from Ligand to King,
Ligand remains liable to Organon in the event of Kings default of this obligation (Note 5). The
Company also incurred approximately $6.6 million in transaction fees and other costs associated
with the sale that are not reflected in the net cash proceeds, of which $3.6 million was recognized
in 2006. The Company recognized approximately $3.6 million in the first quarter of 2007 for
investment banking services and related expenses. The Company disputed the amount of the fees owed
to the investment banking firm and as a result, the parties agreed to settle the matter for $3.0
million, which was paid in June 2007. The Company recorded a pre-tax gain on the sale of $310.1
million in the first quarter of 2007. The Company recorded a $0.3 million pre-tax increase to the
gain on the sale in the second quarter of 2007 due to subsequent changes in certain estimates of
assets and liabilities recorded as of the sale date partially offset by the adjustment to the
investment banking fees discussed above. In the third quarter of 2007, the Company recognized a
$7.5 million pre-tax gain resulting from the release of funds from the escrow account partially
offset by a $0.6 million pre-tax loss due to subsequent changes in certain estimates of assets and
liabilities recorded as of the sale date.
In addition to the assumption of existing royalty obligations, King is required to pay Ligand
a 15% royalty on AVINZA net sales during the first 20 months after Closing. Subsequent royalty
payments will be based upon calendar year net sales. If calendar year net sales are less than
$200.0 million, the royalty payment will be 5% of all net sales. If calendar year net sales are
greater than $200.0 million, the royalty payment will be 10% of all net sales less than $250.0
million, plus 15% of net sales greater than $250.0 million. Royalty revenues were $5.2 million and
$6.6 million for the three and nine months ended September 30, 2007, respectively.
In connection with the sale, the Company has agreed to indemnify King for a period of 16
months after the closing for a number of specified matters including the breach of the Companys
representations, warranties and covenants contained in the asset purchase agreement, and in some
cases for a period of 30 months following the closing of the asset sale. Under the Companys
agreement with King, $15.0 million of the total upfront cash payment was deposited into an escrow
account to secure the Companys indemnification obligations to King following the closing. Of the
escrowed amounts not required for claims to King, $7.5 million was released to the Company on
August 26, 2007, with the remaining balance available for release on February 26, 2008.
20
The Companys indemnification obligations under the asset purchase agreements could cause
Ligand to be liable to King under certain circumstances, in excess of the amount set forth in the
escrow account. The AVINZA asset purchase agreement also allows King, under certain circumstances,
to off set indemnification claims against the royalty payments payable to the Company. Under the
asset purchase agreement, the Companys liability for any indemnification claim brought by King is
generally limited to $40.0 million. However, the Companys obligation to provide indemnification
on certain matters is not subject to this indemnification limit. For example, the Company agreed
to retain, and provide indemnification without limitation to King for all liabilities arising under
certain agreements with Catalent related to the manufacture of AVINZA. The Company cannot predict
the liabilities that may arise as a result of these matters. Any liability claims related to these
matters or any indemnification claims made by King could materially and adversely affect the
Companys financial condition.
In connection with the Transaction, King loaned the Company $37.8 million (the Loan) which
was used to pay the Companys co-promote termination obligation to Organon due October 15, 2006.
This loan was drawn, and the $37.8 million co-promote liability settled in October 2006. Amounts
due under the loan were subject to certain market terms, including a 9.5% interest rate. In
addition, and as a condition of the loan, $38.6 million of the funds received from Eisai was
deposited into a restricted account to be used to repay the loan to King, plus interest. The
Company repaid the loan plus interest in January 2007. As noted above, King refunded the interest
to the Company on the Closing Date.
Also on September 6, 2006, the Company entered into a contract sales force agreement (the
Sales Call Agreement) with King, pursuant to which King agreed to conduct a sales detailing
program to promote the sale of AVINZA for an agreed upon fee, subject to the terms and conditions
of the Sales Call Agreement. Pursuant to the Sales Call Agreement, King agreed to perform certain
minimum monthly product details (i.e. sales calls), which commenced effective October 1, 2006 and
continued until the Closing Date. Co-promotion expense recognized under the Sales Call Agreement
for the three and nine months ended September 30, 2007 was zero and $2.8 million, respectively.
The amount due to King under the Sales Call Agreement as of September 30, 2007 was approximately
$1.8 million. The Sales Call Agreement terminated effective on the Closing Date.
Assets and liabilities of the Companys AVINZA product line on February 26, 2007 were as
follows (in thousands):
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Inventories, net (1) |
|
$ |
2,926 |
|
Other current assets (2) |
|
|
2,780 |
|
|
|
|
|
Total current portion of assets disposed |
|
|
5,706 |
|
|
|
|
|
Equipment, net of accumulated depreciation (1) |
|
|
89 |
|
Acquired technology and product rights, net (1) |
|
|
82,174 |
|
|
|
|
|
Total long-term portion of assets disposed |
|
|
82,263 |
|
|
|
|
|
Total assets disposed |
|
$ |
87,969 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Current liabilities: |
|
|
|
|
Deferred revenue, net (2) |
|
$ |
49,324 |
|
|
|
|
|
Total liabilities disposed |
|
$ |
49,324 |
|
|
|
|
|
|
|
|
(1) |
|
Represents assets acquired by King in accordance with the terms of the AVINZA
Purchase Agreement. |
|
(2) |
|
Represents assets or liabilities eliminated from the Companys consolidated
balance sheet in connection with the AVINZA sale transaction. |
Prior to the AVINZA sale, the Company recorded accruals for rebates, chargebacks, and other
discounts related to AVINZA products when product sales were recognized as revenue under the
sell-through method. Upon the
AVINZA sale, the Company accrued for rebates, chargebacks, and other discounts related to
AVINZA products in
21
the distribution channel which had not sold-through at the time of the AVINZA
sale and for which the Company retained the liability subsequent to the sale. The Companys
accruals for AVINZA rebates, chargebacks, and other discounts total $1.7 million as of September
30, 2007 and are included in accrued liabilities in the accompanying condensed consolidated balance
sheet.
Additionally, and pursuant to the terms of the AVINZA Purchase Agreement, the Company retained
the liability for returns of product from wholesalers that had been sold by the Company prior to
the close of the transaction. Accordingly, as part of the accounting for the gain on the sale of
AVINZA, the Company recorded a reserve for AVINZA product returns. Under the sell-through revenue
recognition method, the Company previously did not record a reserve for returns from wholesalers.
The Companys reserve for AVINZA returns is $10.1 million as of September 30, 2007 and is included
in accrued liabilities in the accompanying condensed consolidated balance sheet.
Results from Discontinued Operations
The following table summarizes results from discontinued operations for the nine months ended
September 30, 2007 (there were no transactions during the three months ended September 30, 2007)
included in the condensed consolidated statements of operations (in thousands):
|
|
|
|
|
|
|
AVINZA |
|
|
|
Product |
|
|
|
Line |
|
Product sales |
|
$ |
18,256 |
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
Cost of products sold |
|
|
3,608 |
|
Research and development |
|
|
120 |
|
Selling, general and administrative |
|
|
3,709 |
|
Co-promotion |
|
|
2,814 |
|
Co-promote termination charges |
|
|
2,012 |
|
Total operating costs and expenses |
|
|
12,263 |
|
|
|
|
|
Income from operations |
|
|
5,993 |
|
Interest expense |
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
5,993 |
|
|
|
|
|
22
The following tables summarize results from discontinued operations for the three and nine
months ended September 30, 2006 included in the condensed consolidated statements of operations (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2006 |
|
|
|
Oncology |
|
|
AVINZA |
|
|
|
|
|
|
Product |
|
|
Product |
|
|
|
|
|
|
Line |
|
|
Line |
|
|
Total |
|
Product sales |
|
$ |
13,292 |
|
|
$ |
36,707 |
|
|
$ |
49,999 |
|
Collaborative research and development
and other revenues |
|
|
75 |
|
|
|
|
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
13,367 |
|
|
|
36,707 |
|
|
|
50,074 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
3,410 |
|
|
|
5,800 |
|
|
|
9,210 |
|
Research and development |
|
|
4,166 |
|
|
|
309 |
|
|
|
4,475 |
|
Selling, general and administrative |
|
|
3,722 |
|
|
|
7,792 |
|
|
|
11,514 |
|
Co-promotion |
|
|
|
|
|
|
11,776 |
|
|
|
11,776 |
|
Co-promote termination charges |
|
|
|
|
|
|
3,643 |
|
|
|
3,643 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
11,298 |
|
|
|
29,320 |
|
|
|
40,618 |
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
2,069 |
|
|
|
7,387 |
|
|
|
9,456 |
|
Interest expense |
|
|
(1 |
) |
|
|
(2,171 |
)(1) |
|
|
(2,172 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
2,068 |
|
|
$ |
5,216 |
|
|
$ |
7,284 |
|
|
|
|
|
|
|
|
|
|
|
23
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2006 |
|
|
|
Oncology |
|
|
AVINZA |
|
|
|
|
|
|
Product |
|
|
Product |
|
|
|
|
|
|
Line |
|
|
Line |
|
|
Total |
|
Product sales |
|
$ |
42,457 |
|
|
$ |
102,853 |
|
|
$ |
145,310 |
|
Collaborative research and development
and other revenues |
|
|
188 |
|
|
|
|
|
|
|
188 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
42,645 |
|
|
|
102,853 |
|
|
|
145,498 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
12,448 |
|
|
|
16,768 |
|
|
|
29,216 |
|
Research and development |
|
|
11,734 |
|
|
|
349 |
|
|
|
12,083 |
|
Selling, general and administrative |
|
|
12,688 |
|
|
|
27,940 |
|
|
|
40,628 |
|
Co-promotion |
|
|
|
|
|
|
33,656 |
|
|
|
33,656 |
|
Co-promote termination charges |
|
|
|
|
|
|
142,980 |
|
|
|
142,980 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
36,870 |
|
|
|
221,693 |
|
|
|
258,563 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
5,775 |
|
|
|
(118,840 |
) |
|
|
(113,065 |
) |
Interest expense |
|
|
(51 |
) |
|
|
(6,894 |
)(1) |
|
|
(6,945 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
5,724 |
|
|
$ |
(125,734 |
) |
|
$ |
(120,010 |
) |
|
|
|
|
|
|
|
|
|
|
(1)As part of the terms of the AVINZA Purchase Agreement, the Company was required to
redeem its outstanding convertible subordinated notes. All of the notes converted into shares
of common stock in 2006 prior to redemption. In accordance with EITF 87-24, Allocation of
Interest to Discontinued Operations, the interest on the notes was allocated to discontinued
operations because the debt was required to be repaid in connection with the disposal
transaction.
A comparison of sales by product for discontinued operations is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
AVINZA |
|
$ |
|
|
|
$ |
36,707 |
|
|
$ |
18,256 |
|
|
$ |
102,853 |
|
ONTAK |
|
|
|
|
|
|
6,574 |
|
|
|
|
|
|
|
23,960 |
|
Targretin capsules |
|
|
|
|
|
|
5,610 |
|
|
|
|
|
|
|
15,608 |
|
Targretin gel and Panretin gel |
|
|
|
|
|
|
1,108 |
|
|
|
|
|
|
|
2,889 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
|
|
|
$ |
49,999 |
|
|
$ |
18,256 |
|
|
$ |
145,310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. Accounts Receivable Factoring Arrangement
During 2003, the Company entered into a one-year accounts receivable factoring arrangement
under which eligible accounts receivable were sold without recourse to a finance company. The
agreement was renewed for a one-year period in the second quarter of 2004 and for two years in the
second quarter of 2005 through December 2007. Commissions on factored receivables are paid to the
finance company based on the gross receivables sold, subject to a minimum annual commission.
Additionally, the Company pays interest on the net outstanding balance of the uncollected factored
accounts receivable at an interest rate equal to the JPMorgan Chase Bank prime rate. The Company
continues to service the factored receivables. The servicing expenses for the three and nine
months ended September 30, 2007 and 2006 and the servicing liability at September 30, 2007 and
December 31, 2006 were not material. There were no material gains or losses on the sale of such
receivables. The Company accounts for the sale of receivables under this arrangement in accordance
with SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishment of
Liabilities (SFAS 140). The gross amount due from the finance company at September 30, 2007 and
December 31, 2006 was zero and $1.0 million, respectively.
24
4. Collaboration Agreements and Royalty Matters
AVINZA Royalty
In connection with the sale of the Companys AVINZA product line to King, King is required to
pay Ligand a 15% royalty on AVINZA net sales during the first 20 months after the Closing Date,
February 26, 2007. Subsequent royalty payments will be based upon calendar year net sales. If
calendar year net sales are less than $200.0 million, the royalty payment will be 5% of all net
sales. If calendar year net sales are greater than $200.0 million, the royalty payment will be 10%
of all net sales less than $250.0 million, plus 15% of net sales greater than $250.0 million. On
September 10, 2007, King reported that Actavis, a manufacturer of generic pharmaceutical products
headquartered in Iceland, had filed with the FDA an Abbreviated New Drug Application, or ANDA, with
a Paragraph IV Certification pertaining to AVINZA, the rights to which were acquired by King
Pharmaceuticals from us in February 2007. According to the report, Actaviss Paragraph IV
Certification sets forth allegations that U.S. Patent No. 6,066,339 (the 339 patent), which is
listed in the FDAs Approved Drug Products With Therapeutic Equivalence Evaluations, will not be
infringed by Actaviss manufacture, use, or sale of the product for which the ANDA was submitted.
The expiration date for this patent is November 2017. King Pharmaceuticals Inc., King
Pharmaceuticals Research and Development, Inc., Elan Corporation, plc and Elan Pharma International
Ltd. jointly filed suit in federal district court in New Jersey on October 18, 2007 against
Actavis, Inc. and Actavis Elizabeth LLC for patent infringement under the 339 patent. The lawsuit
seeks a judgment that would, among other things, prevent Actavis from commercializing their
proposed morphine product until after expiration of the 339 patent.
Product Candidates
The Company has in the past and in the future may receive milestone payments and royalties on
product candidates resulting from its research and development collaboration arrangements with
third party pharmaceutical companies if and to the extent any such product candidate achieves
certain milestones and is ultimately approved by the FDA and successfully marketed. The ability of
the Company to receive and maintain milestone payments and royalties will depend on the Companys
ability and the ability of the Companys partners to avoid infringing the proprietary rights of
others, both in the United States and in foreign countries. In addition, disputes with licensors
under the Companys license agreements have arisen and may arise in the future which could result
in (i) additional financial liability which could be material, (ii) a material loss of important
technology and potential products, and (iii) future or past related revenue, if any. Further, the
manufacture, use or sale of the Companys potential products or the Companys partners products or
potential products may infringe the patent rights of others. This could impact AVINZA,
eltrombopag, bazedoxifene, lasofoxifene, LGD-4665 and any other products or potential products of
the Company or the Companys partners. The Companys current product candidates are discussed
below.
GlaxoSmithKline Collaboration Eltrombopag
Eltrombopag is an oral, small molecule drug that mimics the activity of thrombopoietin, a
protein factor that promotes growth and production of blood platelets. Eltrombopag is a product
candidate that resulted from the Companys collaboration with SmithKline Beecham (now
GlaxoSmithKline). GlaxoSmithKline announced at the European Hematology Association meeting on June
9, 2007 positive Phase III data showing increased platelet count and significantly lower incidence
of bleeding in patients with ITP. An NDA filing for use in treatment of short-term ITP is expected
by the end of 2007. Eltrombopag is currently in the second Phase III trial long-term treatment of
ITP. GlaxoSmithKline reported positive Phase II data in patients with thrombocytopenia associated
with hepatitis C and GlaxoSmithKline initiated two Phase III trials in hepatitis C in
the fourth quarter of 2007. Phase II
trials in chemotherapy-induced thrombocytopenia are ongoing.
If annual net sales of eltrombopag are less than $100.0 million, the Company will earn a
royalty of 5% on such net sales. If eltrombopags annual net sales are between $100.0 million and
$200.0 million, the Company will earn a royalty of 7% on the portion of net sales between $100.0
million and $200.0 million, and if annual net sales are between $200.0 million and $400.0 million,
the Company will earn a royalty of 8% on the portion of net sales
between $200.0 million and $400.0 million. If annual sales exceed $400.0 million, the Company
will earn a royalty of 10% on the portion of net sales exceeding $400.0 million.
The Company
received a letter in October 2007 from
25
Rockefeller University (Rockefeller) claiming that it is
owed 25% of the milestone payments received by the Company from its partner GlaxoSmithKline for
eltrombopag and the backup compound SB-559448, as well as 25% of any future milestone and royalty
payments that the Company may receive from GlaxoSmithKline based on development and
sale of these compounds. To date the Company has received $7 million of milestone payments from
GlaxoSmithKline for these compounds. The Company has reviewed this claim and does not believe that
Rockefeller has a valid basis for its claim for payment and intends to vigorously oppose any
Rockefeller claim for payment related to these matters. In the letter, Rockefeller also stated its
rejection of the Companys notice sent to Rockefeller on August 9, 2007 to terminate the September
30, 1992 license agreement between the Company and Rockefeller.
Wyeth Collaboration bazedoxifene and bazedoxifene in combination with PREMARIN
Bazedoxifene (Viviant) is a product candidate that resulted from the Companys collaboration
with Wyeth. Bazedoxifene is a synthetic drug that was specifically designed to reduce the risk of
osteoporotic fractures while at the same time protecting breast and uterine tissue. In June 2006,
Wyeth announced that a new drug application (NDA) for bazedoxifene had been submitted to the FDA
for the prevention of postmenopausal osteoporosis. FDA issued an approvable letter for
bazedoxifene for this indication in April 2007. Wyeth also submitted a second new drug application (NDA)
for bazedoxifene in the U.S. in July 2007 for the treatment of osteoporosis and a Market
Authorization Application (MAA) to the European Medicines Agency (EMEA) in September 2007 for the
prevention and treatment of osteoporosis.
Wyeth is also developing bazedoxifene in combination with PREMARIN (Aprela) as a
progesterone-free treatment for menopausal symptoms. Two Phase III studies with
bazedoxifene/conjugated estrogens (Aprela), showed reduced number and severity of hot flashes in
symptomatic postmenopausal women by up to 80 percent, when compared with placebo. These data,
presented at the North American Menopause Society Annual Meeting, also showed that
bazedoxifene/conjugated estrogens improved symptoms of vulvar and vaginal atrophy. In addition,
secondary data from both studies showed that when compared with placebo, bazedoxifene/conjugated
estrogens reduced sleep disturbances and improved menopause-related quality of life. Wyeth plans
to submit its New Drug Application (NDA) to the U.S. Food and Drug Administration for
bazedoxifene/conjugated estrogens in the second quarter of 2008 subject to the further analysis and
successful completion of product formulation, bioequivalence and clinical studies, and other
remaining work necessary to finalize the NDA.
The Company previously sold to Royalty Pharma AG (Royalty Pharma) the rights to a total of
3.0% of net sales of bazedoxifene for a period of ten years following the first commercial sale of
each product. After giving effect to the royalty sale, the Company will receive 0.5% of the first
$400.0 million in net annual sales. If net annual sales are between $400.0 million and $1.0
billion, the Company will receive a royalty of 1.5% on the portion of net sales between $400.0
million and $1.0 billion, and if annual sales exceed $1.0 billion, the Company will receive a
royalty of 2.5% on the portion of net sales exceeding $1.0 billion. Additionally, the royalty owed
to Royalty Pharma may be reduced by one third if net product sales exceed certain thresholds across
all indications.
In August 2006 and September 2007, the Company paid Salk $0.8 million and $0.6 million,
respectively, to exercise an option to buy out milestone payments, other payment sharing
obligations and royalty payments due on future sales of bazedoxifene. The submission of Aprela NDA
will trigger an additional option for the Company to buy out its royalty obligation on future sales
of bazedoxifene in combination with PREMARIN to Salk. In April 2007, Salk made a claim that there
are additional patents issued to Salk that increase the amount of royalty buy-out payments. Based
on the context of the claim, the Company believes that Salk is not raising this claim with respect
to the bazedoxifene royalty buy-out payment.
Pfizer Collaboration Lasofoxifene
Lasofoxifene is a product candidate that resulted from the Companys collaboration with
Pfizer. In August 2004, Pfizer submitted a new drug application (NDA) to the FDA for lasofoxifene
for the prevention of osteoporosis in postmenopausal women. In September 2005, Pfizer announced
the receipt of a non-approvable letter from the FDA for the prevention of osteoporosis. In
December 2004, Pfizer filed a supplemental NDA for the
26
use of lasofoxifene for the treatment of
vaginal atrophy. In February 2006, Pfizer announced the receipt of a non-approvable letter from
the FDA for vaginal atrophy. Pfizer has also announced that lasofoxifene is being developed for
the treatment of osteoporosis. In April 2007, Pfizer announced completion of the Postmenopausal
Evaluation and Risk Reduction with Lasofoxifene (PEARL) Phase III study with favorable efficacy and
safety results. Pfizer plans to re-file the lasofoxifene NDA with the FDA towards the end of 2007.
Under the terms of the agreement between Ligand and Pfizer, the Company is entitled to receive
royalty payments equal to 6% of net sales of lasofoxifene worldwide for any indication. The
Company previously sold to Royalty Pharma the rights to a total of 3% of net sales of lasofoxifene
for a period of ten years following the first commercial sale. Accordingly, the Company will
receive approximately 3% of worldwide net annual sales of lasofoxifene.
In March 2004, the Company paid Salk approximately $1.1 million to buy out royalty payments
due on total sales of lasofoxifene for the prevention of osteoporosis. In connection with Pfizers
filing of the supplemental NDA in December 2004 for the use of lasofoxifene for the treatment of
vaginal atrophy, the Company exercised its option to pay Salk $1.1 million to buy out royalty
payments due on sales in this additional indication. In April 2007, Salk made a claim that there
are additional patents issued to Salk that increase the amount of royalty buy-out payments. Based
on the context of the claim, the Company believes that Salk is not raising this claim with respect
to the lasofoxifene royalty buy-out payment. The Company has raised a counterclaim in the
arbitration with Salk seeking either a refund of the two $1.1 million payments or an offset against
any award that may be granted to Salk.
TAP Collaboration LGD-2941
LGD-2941, a selective androgen receptor modulator (SARM), was selected as a clinical candidate
during Ligands collaboration with TAP Pharmaceuticals. SARMs, such as LGD-2941, may contribute to
the treatment of diseases including hypogonadism (low testosterone), sexual dysfunction,
osteoporosis, frailty and cancer cachexia. Phase I development of LGD-2941 commenced in 2005 for
osteoporosis and frailty. The agreement further provides for milestones moving through the
development stage and royalties ranging from 6.0% to 12.0% on annual net sales of drugs resulting
from the collaboration.
5. AVINZA Co-Promotion
In February 2003, Ligand and Organon Pharmaceuticals USA Inc. (Organon) announced that they
had entered into an agreement for the co-promotion of AVINZA. Subsequently in January 2006, Ligand
signed an agreement with Organon that terminated the AVINZA co-promotion agreement between the two
companies and returned AVINZA co-promotion rights to Ligand. The termination was effective as of
January 1, 2006; however, the parties agreed to continue to cooperate during a transition period
that ended September 30, 2006 (the Transition Period) to promote the product. The Transition
Period co-operation included a minimum number of product sales calls per quarter as well as the
transition of ongoing promotions, managed care contracts, clinical trials and key opinion leader
relationships to Ligand. During the Transition Period, Ligand paid Organon an amount equal to 23%
of AVINZA net sales. Ligand also paid and was responsible for the design and execution of all
clinical, advertising and promotion expenses and activities.
Additionally, in consideration of the early termination and return of rights under the terms
of the agreement, Ligand agreed to and paid Organon $37.8 million in October 2006. Ligand further
agreed to and paid Organon $10.0 million in January 2007, in consideration of the minimum sales
calls during the Transition Period. In addition, following the Transition Period, Ligand agreed to
make quarterly royalty payments to Organon equal to 6.5% of AVINZA net sales through December 31,
2012 and thereafter 6.0% through patent expiration, currently anticipated to be November of 2017.
The unconditional payment of $37.8 million to Organon and the estimated fair value of the
amounts to be paid to Organon after the termination ($95.2 million as of January 1, 2006), based on
the estimated net sales of the product (currently anticipated to be paid quarterly through November
2017), were recognized as liabilities and expensed as costs of the termination as of the effective
date of the agreement, January 2006. Additionally, the conditional payment of $10.0 million, which
represents an approximation of the fair value of the service element of the
27
agreement during the Transition Period (when the provision to pay 23% of AVINZA net sales is
also considered), was recognized ratably as additional co-promotion expense over the Transition
Period.
As more fully described in Note 2, on February 26, 2007, Ligand and King closed an agreement
pursuant to which King acquired all of the Companys rights in and to AVINZA, assumed certain
liabilities, and reimbursed Ligand the $47.8 million previously paid to Organon (comprised of the
$37.8 million paid in October 2006 and the $10.0 million that the Company paid in January 2007).
King also assumed the Companys co-promote termination obligation to make payments to Organon based
on net sales of AVINZA. For the fourth quarter of 2006 and through the closing of the AVINZA sale
transaction, amounts owed by Ligand to Organon on net reported sales of AVINZA did not result in
current period expense, but instead were charged against the co-promote termination liability. The
liability was adjusted at each reporting period to fair value and was recognized, utilizing the
interest method, as additional co-promote termination charges for that period at a rate of 15%, the
discount rate used to initially value this component of the termination liability.
In connection with Kings assumption of this obligation, Organon did not consent to the legal
assignment of the co-promote termination obligation to King. Accordingly, Ligand remains liable to
Organon in the event of Kings default of the obligation. Therefore, Ligand recorded an asset as
of February 26, 2007 to recognize Kings assumption of the obligation, while continuing to carry
the co-promote termination liability in the Companys consolidated financial statements to
recognize Ligands legal obligation as primary obligor to Organon as required under SFAS No. 140,
Accounting for Transfers and Servicing of Financial Assets and Extinguishments of Liabilities.
This asset represents a non-interest bearing receivable for future payments to be made by King and
is recorded at its fair value. As of September 30, 2007 and thereafter, the receivable and
liability will remain equal and adjusted each quarter for changes in the fair value of the
obligation including for any changes in the estimate of future net AVINZA product sales. This
receivable will be assessed on a quarterly basis for impairment (e.g. in the event King defaults on
the assumed obligation to pay Organon). As of September 30, 2007, the fair value of the co-promote
termination liability (and the corresponding receivable) was determined using a discount rate of
15%.
On a quarterly basis, management reviews the carrying value of the co-promote termination
liability. Due to assumptions and judgments inherent in determining the estimates of future net
AVINZA sales through November 2017, the actual amount of net AVINZA sales used to determine the
current fair value of the Companys co-promote termination asset and liability may be materially
different from current estimates.
A summary of the co-promote termination liability as of September 30, 2007 is as follows (in
thousands):
|
|
|
|
|
Net present value of payments based on estimated future net
AVINZA product sales as of December 31, 2006 |
|
$ |
93,328 |
|
Payment made in February 2007 to Organon for net AVINZA sales
from October 1, 2006 through December 31, 2006 |
|
|
(2,218 |
) |
Payment made in May 2007 to Organon for net AVINZA sales from
January 1, 2007 through February 26, 2007 |
|
|
(1,187 |
) |
Assumed payments made by King or assignee |
|
|
(2,876 |
) |
September 30, 2007 fair value adjustment of estimated future
payments based on estimated net AVINZA product sales |
|
|
8,628 |
|
|
|
|
|
Total co-promote termination liability as of September 30, 2007 |
|
|
95,675 |
|
Less: remaining current portion of co-promote termination
liability as of September 30, 2007 |
|
|
(14,740 |
) |
|
|
|
|
Long-term portion of co-promote termination liability as of
September 30, 2007 |
|
$ |
80,935 |
|
|
|
|
|
28
6. Sale Leaseback
On October 25, 2006, the Company, along with its wholly-owned subsidiary Nexus, entered into
an agreement with Slough for the sale of the Companys real property located in San Diego,
California for a purchase price of approximately $47.6 million. This property, with a net book
value of approximately $14.5 million, included one building totaling approximately 82,500 square
feet, the land on which the building is situated, and two adjacent vacant lots. As part of the
sale transaction, the Company agreed to leaseback the building for a period of 15 years. In
connection with the sale transaction, on November 6, 2006, the Company also paid off the existing
mortgage on the building of approximately $11.6 million. The early payment triggered a prepayment
penalty of approximately $0.4 million which was recognized in the fourth quarter of 2006. The sale
transaction subsequently closed on November 9, 2006.
Under the terms of the lease, the Company pays a basic annual rent of $3.0 million (subject to
an annual fixed percentage increase, as set forth in the agreement), plus a 1% annual management
fee, property taxes and other normal and necessary expenses associated with the lease such as
utilities, repairs and maintenance, etc. The Company has the right to extend the lease for two
five-year terms and the first right of refusal to lease, at market rates, any facilities built on
the sold lots.
In accordance with SFAS No. 13, Accounting for Leases, the Company recognized an immediate
pre-tax gain on the sale transaction of approximately $3.1 million in the fourth quarter of 2006
and deferred a gain of approximately $29.5 million on the sale of the building. The deferred gain
is recognized on a straight-line basis over the 15 year term of the lease at a rate of
approximately $2.0 million per year. The accretion of the deferred gain was $0.5 million and $1.5
million for the three and nine months ended September 30, 2007, respectively.
7. Litigation
Securities Litigation
The Company was involved in several securities class action and shareholder derivative actions
which followed announcements by the Company in 2004 and the subsequent restatement of its financial
results in 2005. In June 2006, the Company entered into agreements to resolve all claims by the
parties in each of these matters, including those asserted against the Company and the individual
defendants in these cases. Under the agreements, the Company agreed to pay a total of
$12.2 million in cash for a release and in full settlement of all claims. $12.0 million of the
settlement amount and a portion of the Companys total legal expenses were funded by the Companys
Directors and Officers Liability insurance carrier while the remainder of the legal fees incurred
($1.4 million for 2006) was paid by the Company. Of the $12.2 million settlement liability, $4.0
million was paid in October 2006 to Ligands insurance carrier and then disbursed to the claimants
attorneys, while $8.0 million was paid in July 2006 by the insurance carrier directly to an
independent escrow agent responsible for disbursing the funds to the class action suit claimants.
As part of the settlement of the state derivative action, the Company agreed to adopt certain
corporate governance enhancements including the formalization of certain Board practices and
responsibilities, a Board self-evaluation process, Board and Board Committee term limits (with
gradual phase-in) and one-time enhanced independence requirements for a single director to succeed
the current shareholder representatives on the Board. Neither the Company nor any of its current
or former directors and officers has made any admission of liability or wrongdoing. On October 12,
2006, the Superior Court of California approved the settlement of the state and federal derivative
actions and entered final judgment of dismissal. The United States District Court approved the
settlement of the Federal class action in October 2006.
SEC Investigation
The SEC issued a formal order of private investigation dated September 7, 2005, which was
furnished to Ligands legal counsel on September 29, 2005, to investigate the circumstances
surrounding Ligands restatement of its consolidated financial statements for the years ended
December 31, 2002 and 2003, and for the first three quarters of 2004. The SEC has issued subpoenas
for the production of documents and for testimony pursuant to that investigation to Ligand and
others. The SECs investigation is ongoing and Ligand is cooperating with the investigation.
29
Other Matters
The Companys subsidiary, Seragen, Inc. and Ligand, were named parties to Sergio M. Oliver, et
al. v. Boston University, et al., a shareholder class action filed on December 17, 1998 in the
Court of Chancery in the State of Delaware in and for New Castle County, C.A. No. 16570NC, by
Sergio M. Oliver and others against Boston University and others, including Seragen, its subsidiary
Seragen Technology, Inc. and former officers and directors of Seragen. The complaint, as amended,
alleged that Ligand aided and abetted purported breaches of fiduciary duty by the Seragen related
defendants in connection with the acquisition of Seragen by Ligand and made certain
misrepresentations in related proxy materials and seeks compensatory and punitive damages of an
unspecified amount. On July 25, 2000, the Delaware Chancery Court granted in part and denied in
part defendants motions to dismiss. Seragen, Ligand, Seragen Technology, Inc. and the Companys
acquisition subsidiary, Knight Acquisition Corporation, were dismissed from the action. Claims of
breach of fiduciary duty remain against the remaining defendants, including the former officers and
directors of Seragen. The court certified a class consisting of shareholders as of the date of the
acquisition and on the date of the proxy sent to ratify an earlier business unit sale by Seragen.
On January 20, 2005, the Delaware Chancery Court granted in part and denied in part the defendants
motion for summary judgment. Prior to trial, several of the Seragen director-defendants reached a
settlement with the plaintiffs. The trial in this action then went forward as to the remaining
defendants and concluded on February 18, 2005. On April 14, 2006, the court issued a memorandum
opinion finding for the plaintiffs and against Boston University and individual directors
affiliated with Boston University on certain claims. The opinion awards damages on these claims in
the amount of approximately $4.8 million plus interest. Judgment, however, has not been entered
and the matter is subject to appeal. While Ligand and its subsidiary Seragen have been dismissed
from the action, such dismissal is also subject to appeal and Ligand and Seragen may have possible
indemnification obligations with respect to certain defendants. As of September 30, 2007, the
Company has not accrued an indemnification obligation based on its assessment that the Companys
responsibility for any such obligation is not probable or estimable.
The Company received a letter in March 2007 from counsel to The Salk Institute for Biological
Studies (Salk) alleging the Company owes Salk royalties on prior product sales of Targretin as
well as a percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai Inc. (New
Jersey) in the asset sale transaction completed with Eisai in October 2006. Salk alleges that it
is owed at least 25% of the consideration paid by Eisai for that portion of the Companys oncology
product line and associated assets attributable to Targretin. In an April 11, 2007 request for
mediation, Salk repeated these claims and asserted additional claims that allegedly increase the
amount of royalty buy-out payments. Representatives from Ligand and Salk attended a mediation
hearing in June 2007, which left the matter unresolved. Salk filed a demand for arbitration in
July 2007 with the American Arbitration Association, seeking at least $22 million for alleged
breach of contract based on Salks theory that it is entitled to a portion of the money paid by
Eisai to Ligand for Targretin related assets. The Company does not believe that Salk has a valid
basis for its claims and intends to vigorously oppose any claim that Salk has brought or may bring
for payment related to these matters. The Company has raised a counterclaim in the arbitration
with Salk seeking either a refund of the two $1.1 million lasofoxifene related payments or an
offset against any award that may be granted to Salk. The arbitration with Salk is ongoing.
The Company received a letter in October 2007 from Rockefeller University (Rockefeller)
claiming that it is owed 25% of the milestone payments received by the Company from its partner
GlaxoSmithKline for eltrombopag and the backup compound SB-559448, as well as 25% of any future
milestone and royalty payments that the Company may receive in the future from GlaxoSmithKline
based on development and sale of these compounds. To date the Company has received $7 million of
milestone payments from GlaxoSmithKline for these compounds. The Company has reviewed this claim
and does not believe that Rockefeller has a valid basis for its claim for payment and intends to
vigorously oppose any Rockefeller claim for payment related to these matters. In the letter,
Rockefeller also stated its rejection of the Companys notice sent to Rockefeller on August 9, 2007
to terminate the September 30, 1992 license agreement between the Company and Rockefeller.
The Company recorded approximately $6.6 million (net) in transaction fees and other costs associated
with the sale of AVINZA to King (see Note 2). This amount includes approximately $3.6 million for
investment banking services
and related expenses. The Company disputed the amount of the fees owed to the investment
banking firm and as a result, the parties agreed to settle the matter for $3.0 million, which was
paid in June 2007.
30
In addition, the Company is subject to various lawsuits and claims with respect to matters
arising out of the normal course of business. Due to the uncertainty of the ultimate outcome of
these matters, the impact on future financial results is not subject to reasonable estimates.
8. New Accounting Pronouncements
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value under GAAP, and expands
disclosures about fair value measurements. SFAS 157 applies under other accounting pronouncements
that require or permit fair value measurements where fair value has previously been concluded to be
the relevant measurement attribute. SFAS 157 is effective for financial statements issued for
fiscal years beginning
after November 15, 2007. The Company will adopt SFAS 157 in the first interim period of
fiscal 2008 and is evaluating the impact, if any, that the adoption of this statement will have on
its consolidated results of operations and financial position.
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 159). SFAS 159
permits entities to choose to measure many financial instruments and certain other items at fair
value. Most of the provisions of SFAS 159 apply only to entities that elect the fair value option;
however, the amendment to FASB Statement No. 115, Accounting for Certain Investments in Debt and
Equity Securities, applies to all entities with available-for-sale and trading securities. SFAS
159 is effective for financial statements issued for fiscal years beginning after November 15,
2007. The Company will adopt SFAS 159 in the first interim period of fiscal 2008 and is evaluating
the impact, if any, that the adoption of this statement will have on its consolidated results of
operations and financial position.
In June 2007, the FASB ratified the consensus reached by the EITF in Issue No. 07-3,
Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research
and Development Activities (EITF 07-3). EITF 07-3 requires that nonrefundable advance payments
for future research and development activities should be deferred and capitalized. EITF 07-3 is
effective for financial statements issued for fiscal years beginning after December 15, 2007. The
Company will adopt EITF 07-3 in the first interim period of fiscal 2008 and is evaluating the
impact, if any, that the adoption of this issue will have on its consolidated results of
operations and financial position.
9. Employment Retention Agreements and Severance Arrangements
In March 2006, the Company entered into letter agreements with approximately 67 key employees,
including a number of its executive officers. In September 2006, the Company entered into letter
agreements with ten additional employees and modified existing agreements with two employees.
These letter agreements provided for certain retention or stay bonus payments to be paid in cash
under specified circumstances as an additional incentive to remain employed in good standing with
the Company through December 31, 2006. The Compensation Committee of the Board of Directors
approved the Companys entry into these agreements. In accordance with the SFAS 146, Accounting
for Costs Associated with Exit or Disposal Activities, the cost of the plan was ratably accrued
over the term of the agreements. Since the retention or stay bonus
payments generally vested at the
end of 2006 and the total payments to employees was paid in January 2007, the Company recognized
approximately $2.6 million of expense under the plan in 2006 including $1.0 million and $2.1
million, respectively, for the three and nine months ended September 30, 2006.
Additionally, in October 2006, the Company implemented a 2006 Employee Severance Plan for
those employees who were not covered by another severance arrangement. The plan provided that if
such an employee was involuntarily terminated without cause, and not offered a similar or better
job by one of the purchasers of the product lines (i.e. King or Eisai) such employee would be
eligible for severance benefits. The benefits consist of two months salary, plus one week of
salary for every full year of service with the Company plus payment of COBRA health care coverage
premiums for that same period.
31
In August 2007,
the Compensation Committee of the Companys Board of Directors approved and
ratified change of control agreements with the Companys executive officers and certain
of the Companys management. In the event the employment of any of the Companys executive
officers is involuntarily terminated in connection with a change of control of the Company, such
person, with the exception of the Chief Executive Officer, will receive one year of salary and
COBRA health care benefits plus the maximum target bonus for the year. In the event the Chief
Executive Officers employment is involuntarily terminated in connection with a change of control
of the Company, he will receive two years of salary and COBRA health care benefits plus two times
the maximum target bonus for the year. The amounts will be payable in a lump sum
following the termination of employment. The change of control agreements also
accelerate the vesting of all outstanding unvested stock awards and provide that the stock awards
may be exercised until nine months after termination or such longer period as may be specified in
the applicable stock award agreement, except that no stock award will remain exercisable beyond the
original outside expiration date of such stock award.
10. Appointment of New CEO
On August 1, 2006, the Company announced that current director Henry F. Blissenbach had been
named Chairman and interim Chief Executive Officer. The Company agreed to pay Dr. Blissenbach
$40,000 per month, commencing August 1, 2006 for his services as Chairman and interim Chief
Executive Officer. In addition, Dr. Blissenbach was eligible to receive incentive compensation of
up to 50% of his base salary, but not more than $100,000, based upon his performance of certain
objectives incorporated within the employment agreement which we and Dr. Blissenbach entered into.
As those performance objectives were
achieved, the Company paid the $100,000 in incentive compensation to Dr. Blissenbach in
February 2007. Also, Dr. Blissenbach received a stock option grant to purchase 150,000 shares of
the Companys common stock at an exercise price of $6.70 per share (adjusted to reflect the March
22, 2007 equitable adjustment of employee stock options). These stock options vested upon the
appointment of a new chief executive officer in January 2007. Dr. Blissenbach ceased to be a
director of the Company effective May 31, 2007. Under the original terms of his stock option
agreement, Dr. Blissenbach may exercise his option for a period of three months following the date
of cessation of Dr. Blissenbachs service as a director of the Company. In July 2007, the
compensation committee of the Board of Directors extended the period of time for which such option
is to remain exercisable, but only with respect to the purchase of 25,000 shares of the underlying
common stock, such that Dr. Blissenbach would have three years to exercise his option to purchase
such 25,000 shares. As a result of this modification, the Company recorded compensation expense of
$0.06 million for the three and nine months ended September 30, 2007. The option to purchase the
remaining 125,000 shares expired 90 days after the date of cessation of Dr. Blissenbachs service
on the Companys Board of Directors. Finally, the Company reimbursed Dr. Blissenbach for all
reasonable expenses incurred in discharging his duties as interim Chief Executive Officer,
including, but not limited to commuting costs to San Diego and living and related costs during the
time he spent in San Diego.
On January 15, 2007, the Company announced that John L. Higgins had joined the Company as
Chief Executive Officer and President. Mr. Higgins succeeded Dr. Blissenbach, who continued to
serve as Chairman of the Board of Directors until March 1, 2007. The Company has agreed to
pay Mr. Higgins an annual salary of $400,000, with his employment commencing as of January 10,
2007. In addition, Mr. Higgins has a performance bonus opportunity with a target of 50% of his
salary, up to a maximum of 75%, and received a restricted stock grant of 150,000 shares of the
Companys common stock vesting over two years. The Company also provided Mr. Higgins with a
lump-sum relocation benefit of $100,000. Mr. Higgins employment agreement provides for severance
payments and benefits in the event that employment is terminated under various scenarios, such as a
change in control of the Company.
11. Reductions in Workforce
In December 2006, and following the sale of the Companys Oncology Product Line to Eisai, the
Company entered into a plan to eliminate 40 employee positions, across all functional areas, which
were no longer deemed necessary considering the Companys decision to sell its commercial assets.
Additionally, the Company terminated 23 AVINZA sales representatives and regional business managers
who were not offered positions with King or declined Kings offer of employment. The affected
employees were informed of the plan in
December 2006 with an effective termination date of January 2, 2007. In connection with the
termination plan, the
32
Company recognized operating expenses of approximately $2.9 million in the
fourth quarter of 2006, comprised of one-time severance benefits of $2.3 million, stock
compensation of $0.3 million, and other costs of $0.3 million. The stock compensation charge
resulted from the accelerated vesting and extension of the exercise period of stock options in
accordance with severance arrangements of certain senior management members. The Company paid $0.5
million in December 2006 and the remaining balance in January 2007.
On January 31, 2007, the Company announced a restructuring plan calling for the elimination of
approximately 204 positions across all functional areas. This reduction was made in connection
with the Companys efforts to refocus the Company, following the sale of its commercial assets, as
a smaller, highly focused research and development and royalty-driven biotech company. Associated
with the restructuring and refocused business model, several of its executive officers stepped down
including its Chief Financial Officer, Chief Scientific Officer and General Counsel. In connection
with the termination of its officers and the payment of severance, the Company entered into
one-year consulting agreements with each officer at hourly rates commensurate with the officers
salary compensation in effect as of the date of termination. Amounts owed to these officers for
services provided during the nine months ended September 30, 2007 were not material. The Company
also announced that its primary operations are expected to be consolidated into one building with
the goal to sublet unutilized space. In connection with the restructuring, the Company recorded
severance and other related charges in the first quarter of 2007 totaling $10.2 million, comprised
of one-time severance benefits of $7.1 million, stock compensation of $2.3 million, and other costs
of $0.8 million. Of the one-time severance benefits of $7.1 million, $2.1 million is included in
general and administrative expenses, $4.4 million is included in research and development expenses,
and $0.6 million is included in discontinued operations. Of the stock compensation charges of $2.3
million, $1.0 million is included in general and administrative expenses and $1.3 million is
included in research and development expenses. The Company recorded severance and other related
charges in the second quarter of 2007 totaling $1.0 million, comprised of one-time severance
benefits of $0.9 million and stock compensation of $0.1 million. Of the one-time severance
benefits of $0.9 million, $0.7 million is included in general and administrative expenses and $0.2
million is included in research and development expenses. All of the stock compensation charges
are included in general and administrative expenses. The Company recorded severance charges in the
third quarter of 2007 totaling $0.02 million, which relate to one-time severance benefits and are
included in general and administrative
expenses. The stock compensation charges result from the accelerated vesting and extension of
the exercise period of stock options in accordance with severance arrangements of certain senior
management members.
12. Funding of Legacy Director Indemnity Fund
On March 1, 2007, the Company entered into an indemnity fund agreement, which established in a
trust account with Dorsey & Whitney LLP, (Dorsey) counsel to the Companys independent directors
and to the Audit Committee of the Companys Board of Directors, a $10.0 million indemnity fund to
support the Companys existing indemnification obligations to continuing and departing directors in
connection with the ongoing SEC investigation and related matters. Ligand has agreed to supplement
the indemnity fund upon Dorseys request should the fund become insufficient to cover liabilities
and defense costs required to be paid under the Companys indemnification agreements. Upon the
earlier of (i) the resolution of the SEC investigation and related matters, (ii) the expiration of
24 months after receipt of any written or oral communication initiated by the SEC regarding the
investigation, (iii) written communications from the SEC that the investigation has been
discontinued, or (iv) otherwise by the mutual agreement of the parties to terminate the indemnity
fund agreement, Dorsey will remit the remaining balance of the fund to Ligand. The balance of this
fund, amounting to $10.0 million, has been recorded as restricted indemnification account in the
accompanying condensed consolidated balance sheet as of September 30, 2007.
13. Return of Cash to Shareholders/Equitable Adjustment of Employee Stock Options
On March 22, 2007, the Company declared a cash dividend on the common stock of the Company of
$2.50 per share. As the Company has an accumulated deficit, the dividend was recorded as a charge
against additional paid-in capital in the first quarter of 2007. The aggregate amount of $252.7
million was paid on April 19, 2007 to shareholders of record as of April 5, 2007. In addition to
the cash dividend, the Board of Directors authorized up to $100.0 million in share repurchases over
the subsequent 12 months. For the three months ended September 30, 2007, the Company repurchased
1.6 million shares of its common stock totaling $10.1 million. For the nine months
ended September 30, 2007, the Company repurchased 5.4 million shares of its common stock
totaling $35.5 million.
33
During October 2007, the Company repurchased an additional 0.4 million
shares of its common stock totaling $2.2 million.
In February 2007, the Companys shareholders approved a modification to the 2002 Stock
Incentive Plan (the 2002 Plan) to allow equitable adjustments to be made to options outstanding
under the 2002 Plan. Effective April 2007, the Company reduced the exercise price by $2.50 (or to
the par value of the stock for those options with an exercise price below $2.50 per share), as an
equitable adjustment, for all options then outstanding under the 2002 Plan to reflect the special
cash dividend. Under the requirements of SFAS 123(R), the Company will recognize approximately
$2.0 million of stock compensation expense in connection with the equitable adjustment effective
March 28, 2007, the date the Compensation Committee of the Companys Board of Directors approved
the equitable adjustment. For the three and nine months ended September 30, 2007, $0.01 million
and $1.8 million of stock compensation expense was recognized, respectively, and the remaining $0.2
million will be recognized over the remaining vesting period of the options which were unvested as
of the modification date.
14. Income Taxes
The Company had losses from continuing operations and income from discontinued operations for
the three and nine months ended September 30, 2007. In accordance with SFAS No. 109, Accounting
for Income Taxes, the income tax benefit generated by the loss from continuing operations for the
three and nine months ended September 30, 2007 was $2.4 million and $15.8 million, respectively.
This income tax benefit captures the deemed use of losses from continuing operations used to offset
the income and gain from the Companys AVINZA product line that was sold on February 26, 2007.
Net income tax benefit combining both continuing and discontinued operations was $3.7 million
and a net income tax expense of $10.0 million for the three and nine months ended September 30,
2007, respectively. The income tax benefit for the three months ended September 30, 2007 reflects
the deemed use of losses from continuing operations reflected in the application of the annual
effective tax rate which is offset, in part, by the income tax expense recorded discretely most
significantly in the first quarter from the sale of the Companys AVINZA product line on February
26, 2007. The income tax benefit of $1.4 million recorded discretely in the third quarter from the
sale of the AVINZA product line reflects a reduction in income tax that was recorded in previous
quarters of 2007. The income tax expense for the nine months ended September 30, 2007 reflects the
net tax due on taxable income that was not fully offset by net operating loss and research and
development credit carryforwards due to federal and state alternative minimum tax requirements.
This tax expense will be offset in part by a tax benefit in the fourth quarter. This fourth
quarter income tax benefit will reflect the deemed use of losses from continuing operations used to
offset the income and gain from the Companys AVINZA product
line. Net income tax expense combining both continuing and discontinued operations was $0.02
million and $0.1 million for the three and nine months ended September 30, 2006, respectively.
After giving effect to the AVINZA sale transaction and estimated taxable operating losses
through September 30, 2007, the Company expects that Ligands federal NOLs will approximate $104
million as of December 31, 2007, against which a full valuation allowance has been provided as of
September 30, 2007 and for which it is expected to be provided for as of December 31, 2007. This
amount excludes NOLs of the Companys Seragen and Glycomed subsidiaries. The information necessary
to determine if an ownership change related to Seragen and Glycomed occurred prior to their
acquisition by Ligand is not currently available. Accordingly, the Companys ability to utilize
such net tax operating loss carryforwards is uncertain and therefore such NOLs are not reflected in
the Companys deferred tax assets.
The Company adopted the provisions of FIN 48 on January 1, 2007. As a result of the
implementation of FIN 48, the Company recognized a $0.4 million increase in the liability for
unrecognized income tax benefits, which was accounted for as an adjustment to the beginning balance
of accumulated deficit on the condensed consolidated balance sheet. In connection with the sale of
the Companys AVINZA product line in February 2007, the circumstances giving rise to this
unrecognized income tax benefit were resolved. Accordingly, this liability was adjusted down
through a credit to the Companys tax provision from discontinued operations in the first quarter
of
2007. At the adoption date of January 1, 2007, the Company had $0.4 million of unrecognized
tax benefits, all of
34
which affected the Companys effective tax rate when recognized discretely
during the first quarter of 2007. At September 30, 2007, the Company has no material unrecognized
tax benefits.
The Company recognizes interest and penalties related to uncertain tax positions in income tax
expense. As of September 30, 2007, accrued interest related to uncertain tax positions is not
material.
All of the Companys tax years from 1991-2006 remain open to examination by the major taxing
jurisdictions to which the Company is subject.
35
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Caution: This discussion and analysis may contain predictions, estimates and other
forward-looking statements that involve a number of risks and uncertainties, including those
discussed in Item 1A. Risk Factors. This outlook represents our current judgment on the future
direction of our business. These statements include those related to our restructuring process,
AVINZA royalty revenues, product returns, product development, and our 2005 restatement. Actual
events or results may differ materially from Ligands expectations. For example, there can be no
assurance that our revenues or expenses will meet any expectations or follow any trend(s), that our
internal control over financial reporting will be effective or produce reliable financial
information on a timely basis, or that our restructuring process will be successful or yield
preferred results. We cannot assure you that we will be able to successfully or timely complete
our restructuring, that we will receive expected AVINZA royalties to support our ongoing business,
or that our internal or partnered pipeline products will progress in their development, gain
marketing approval or success in the market. In addition, our ongoing SEC investigation or future
litigation may have an adverse effect on us. Such risks and uncertainties, and others, could cause
actual results to differ materially from any future performance suggested. We undertake no
obligation to release publicly the results of any revisions to these forward-looking statements to
reflect events or circumstances arising after the date of this quarterly report. This caution is
made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 as
amended.
Our trademarks, trade names and service marks referenced herein include Ligand. Each other
trademark, trade name or service mark appearing in this quarterly report belongs to its owner.
References to Ligand Pharmaceuticals Incorporated (Ligand, the Company, we or our)
include our wholly owned subsidiaries Ligand Pharmaceuticals (Canada) Incorporated; Ligand
Pharmaceuticals International, Inc.; Seragen, Inc. (Seragen); and Nexus Equity VI LLC (Nexus).
Overview
We are an early-stage biotech company that focuses on discovering and developing new drugs
that address critical unmet medical needs in the areas of thrombocytopenia, cancer, hepatitis C,
hormone related diseases, osteoporosis and inflammatory diseases. We strive to develop drugs that
are more effective and/or safer than existing therapies, that are more convenient to administer and
that are cost effective. We plan to build a profitable company by generating income from research,
milestone and royalty and co-promotion revenues resulting from our collaborations with
pharmaceutical partners.
On September 7, 2006, we announced the sale of ONTAK, Targretin capsules, Targretin gel, and
Panretin gel to Eisai, Inc., or Eisai, and the sale of AVINZA to King Pharmaceuticals, Inc., or
King. The Eisai sales transaction subsequently closed on October 25, 2006. The AVINZA sale
transaction subsequently closed on February 26, 2007. Accordingly, the results for the Oncology
and AVINZA product lines have been presented in our condensed consolidated statements of operations
for the three and nine months ended September 30, 2007 and 2006 as Discontinued Operations.
We are a party to a number of collaboration arrangements that are in the development phase
including with GlaxoSmithKline, Pfizer, TAP, and Wyeth. We received funding during the research
phase of the arrangements, and milestone and royalty payments as products are developed and
marketed by our corporate partners. See Potential Future Revenue Sources below. In addition, in
connection with some of these collaborations, we received non-refundable up-front payments.
We have been unprofitable since our inception on an annual basis and expect to incur net
losses in the future. To be profitable, we must successfully develop, clinically test, market and
sell our products. Even if we achieve profitability, we cannot predict the level of that
profitability or whether we will be able to sustain profitability. We expect that our operating
results will fluctuate from period to period as a result of differences in the timing and amounts
of revenues, including royalties expected to be earned in the future from King on sales of AVINZA,
expenses incurred, collaborative arrangements and other sources. Some of these fluctuations may be
significant.
36
Potential Future Revenue Sources
We may receive royalties on product candidates resulting from our research and development
collaboration arrangements with third party pharmaceutical companies if and to the extent any such
product candidate is ultimately approved by the FDA and successfully marketed. The Companys
current product candidates are discussed below.
GlaxoSmithKline Collaboration Eltrombopag
Eltrombopag is an oral, small molecule drug that mimics the activity of thrombopoietin, a
protein factor that promotes growth and production of blood platelets. Eltrombopag is a product
candidate that resulted from our collaboration with SmithKline Beecham (now GlaxoSmithKline).
GlaxoSmithKline announced at the European Hematology Association meeting on June 9, 2007 positive
Phase III data showing increased platelet count and significantly lower incidence of bleeding in
patients with Idiopathic Thrombocytopenia Purpura (ITP). An NDA filing for use in treatment of
short-term ITP is expected by the end of 2007. Eltrombopag is currently in the second Phase III
trial for the long-term treatment of ITP. GlaxoSmithKline reported positive Phase II data in
patients with thrombocytopenia associated with hepatitis C and Glaxo
SmithKline initiated two Phase III trials in hepatitis C in the
fourth quarter of 2007. Phase II trials in chemotherapy-induced thrombocytopenia are
ongoing.
If annual net sales of eltrombopag are less than $100.0 million, we will earn a royalty of 5%
on such net sales. If eltrombopags annual net sales are between $100.0 million and $200.0
million, we will earn a royalty of 7% on the portion of net sales between $100.0 million and $200.0
million, and if annual net sales are between $200.0 million and $400.0 million, we will earn a
royalty of 8% on the portion of net sales between $200.0 million and $400.0 million. If annual
sales exceed $400.0 million, we will earn a royalty of 10% on the portion of net sales exceeding
$400.0 million.
We
received a letter in October 2007 from Rockefeller University, or Rockefeller,
claiming that it is owed 25% of the milestone payments received by us from our partner
GlaxoSmithKline for eltrombopag and the backup compound SB-559448, as well as 25% of any future
milestone and royalty payments that we may receive from GlaxoSmithKline based on
development and sale of these compounds. To date we have received $7 million of milestone payments
from GlaxoSmithKline for these compounds. We have reviewed this claim and do not believe that
Rockefeller has a valid basis for its claim for payment and intends to vigorously oppose any
Rockefeller claim for payment related to these matters. In the letter, Rockefeller also stated its
rejection of the Companys notice sent to Rockefeller on August 9, 2007 to terminate the September
30, 1992 license agreement between us and Rockefeller.
Wyeth Collaboration bazedoxifene and bazedoxifene in combination with PREMARIN
Bazedoxifene (Viviant) is a product candidate that resulted from our collaboration with Wyeth.
Bazedoxifene is a synthetic drug that was specifically designed to reduce the risk of osteoporotic
fractures while at the same time protecting breast and uterine tissue. In June 2006, Wyeth
announced that a new drug application (NDA) for bazedoxifene had been submitted to the FDA for
the prevention of postmenopausal osteoporosis. FDA issued an approvable letter for bazedoxifene
for this indication in April 2007. Wyeth also submitted a second new drug application (NDA) for bazedoxifene
in the U.S. in July 2007 for the treatment of osteoporosis and a Market Authorization Application
(MAA) to the European Medicines Agency (EMEA) in September 2007 for the prevention and treatment of
osteoporosis.
Wyeth is also developing bazedoxifene in combination with PREMARIN (Aprela) as a
progesterone-free treatment for menopausal symptoms. Two Phase III studies with
bazedoxifene/conjugated estrogens (Aprela), showed reduced number and severity of hot flashes in
symptomatic postmenopausal women by up to 80 percent, when compared with placebo. These data,
presented at the North American Menopause Society Annual Meeting, also showed that
bazedoxifene/conjugated estrogens improved symptoms of vulvar and vaginal atrophy. In addition,
secondary data from both studies showed that when compared with placebo, bazedoxifene/conjugated
estrogens reduced sleep disturbances and improved menopause-related quality of life. Wyeth plans
to submit its New Drug Application (NDA) to the U.S. Food and Drug Administration for
bazedoxifene/conjugated estrogens in
37
the second quarter of 2008 subject to the further analysis and successful completion of
product formulation, bioequivalence and clinical studies, and other remaining work necessary to
finalize the NDA.
We previously sold to Royalty Pharma AG, or Royalty Pharma, the rights to a total of 3.0% of
net sales of bazedoxifene for a period of ten years following the first commercial sale of each
product. After giving effect to the royalty sale, we will receive 0.5% of the first $400.0 million
in net annual sales. If net annual sales are between $400.0 million and $1.0 billion, we will
receive a royalty of 1.5% on the portion of net sales between $400.0 million and $1.0 billion, and
if annual sales exceed $1.0 billion, we will receive a royalty of 2.5% on the portion of net sales
exceeding $1.0 billion. Additionally, the royalty owed to Royalty Pharma may be reduced by one
third if net product sales exceed certain thresholds across all indications.
In August 2006 and September 2007, we paid Salk $0.8 million and $0.6 million, respectively,
to exercise an option to buy out milestone payments, other payment sharing obligations and royalty
payments due on future sales of bazedoxifene. The submission of Aprela NDA will trigger an
additional option for us to buy out our royalty obligation on future sales of bazedoxifene in
combination with PREMARIN to Salk. In April 2007, Salk made a claim that there are additional
patents issued to Salk that increase the amount of royalty buy-out payments. Based on the context
of the claim, we believe that Salk is not raising this claim with respect to the bazedoxifene
royalty buy-out payment.
Pfizer Collaboration Lasofoxifene
Lasofoxifene is a product candidate that resulted from our collaboration with Pfizer. In
August 2004, Pfizer submitted a new drug application (NDA) to the FDA for lasofoxifene for the
prevention of osteoporosis in postmenopausal women. In September 2005, Pfizer announced the
receipt of a non-approvable letter from the FDA for the prevention of osteoporosis. In December
2004, Pfizer filed a supplemental NDA for the use of lasofoxifene for the treatment of vaginal
atrophy. In February 2006, Pfizer announced the receipt of a non-approvable letter from the FDA
for vaginal atrophy. Pfizer has also announced that lasofoxifene is being developed for the
treatment of osteoporosis. In April 2007, Pfizer announced completion of the Postmenopausal
Evaluation and Risk Reduction with lasofoxifene (PEARL) Phase III study with favorable efficacy and
safety. Pfizer plans to re-file the lasofoxifene NDA with the FDA towards the end of 2007.
Under the terms of the agreement between Ligand and Pfizer, we are entitled to receive royalty
payments equal to 6% of net sales of lasofoxifene worldwide for any indication. We previously sold
to Royalty Pharma the rights to a total of 3% of net sales of lasofoxifene for a period of ten
years following the first commercial sale. Accordingly, we will receive approximately 3% of
worldwide net annual sales of lasofoxifene.
In March 2004, we paid Salk approximately $1.1 million to buy out royalty payments due on
total sales of lasofoxifene for the prevention of osteoporosis. In connection with Pfizers filing
of the supplemental NDA in December 2004 for the use of lasofoxifene for the treatment of vaginal
atrophy, we exercised our option to pay Salk $1.1 million to buy out royalty payments due on sales
in this additional indication. In April 2007, Salk made a claim that there are additional patents
issued to Salk that increase the amount of royalty buy-out payments. Based on the context of the
claim, we believe that Salk is not raising this claim with respect to the lasofoxifene royalty
buy-out payment. The Company has raised a counterclaim in the arbitration with Salk seeking either
a refund of the two $1.1 million payments or an offset against any award that may be granted to
Salk.
TAP Collaboration LGD-2941
LGD-2941, a selective androgen receptor modulator (SARM), was selected as a clinical candidate
during Ligands collaboration with TAP Pharmaceuticals. SARMs, such as LGD-2941, may contribute to
the treatment of diseases including hypogonadism (low testosterone), sexual dysfunction,
osteoporosis, frailty and cancer cachexia. Phase I development of LGD-2941 commenced in 2005 for
osteoporosis and frailty. The agreement further provides for milestones moving through the
development stage and royalties ranging from 6.0% to 12.0% on annual net sales of drugs resulting
from the collaboration.
38
Recent Developments
Filing of Paragraph IV Certification Pertaining to AVINZA
On September 10, 2007, King Pharmaceuticals (King) reported that Actavis, a manufacturer of
generic pharmaceutical products headquartered in Iceland, had filed with the FDA an Abbreviated New
Drug Application, or ANDA, with a Paragraph IV Certification pertaining to AVINZA, the rights to
which were acquired by King Pharmaceuticals from us in February 2007. According to the report,
Actaviss Paragraph IV Certification sets forth allegations that U.S. Patent No. 6,066,339 (the
339 patent), which is listed in the FDAs Approved Drug Products With Therapeutic Equivalence
Evaluations, will not be infringed by Actaviss manufacture, use, or sale of the product for which
the ANDA was submitted. The expiration date for this patent is November 2017. King
Pharmaceuticals Inc., King Pharmaceuticals Research and Development, Inc., Elan Corporation, plc
and Elan Pharma International Ltd. jointly filed suit in federal district court in New Jersey on
October 18, 2007 against Actavis, Inc. and Actavis Elizabeth LLC for patent infringement under the
339 patent. The lawsuit seeks a judgment that would, among other things, prevent Actavis from
commercializing their proposed morphine product until after expiration of the 339 patent.
Termination of License Agreement
On August 9, 2007, we sent notice to Rockefeller University, or Rockefeller, that, pursuant to
the terms of the license agreement, dated September 30, 1992, by and between us and Rockefeller, we
were exercising our right to terminate the license agreement without cause upon ninety (90) days
prior written notice to Rockefeller. Under the terms of the license agreement with Rockefeller, we
acquired worldwide licensing rights to certain transcription technology developed by Rockefeller.
On October 4, 2007, we received a letter from Rockefeller claiming that it is owed 25% of the
milestone payments received by us from our partner GlaxoSmithKline for eltrombopag and the backup
compound SB-559448, as well as 25% of any future milestone and royalty payments that we may receive
in the future from GlaxoSmithKline based on development and sale of these compounds. To date we
have received $7 million of milestone payments from GlaxoSmithKline for these compounds. We have
reviewed this claim and do not believe that Rockefeller has a valid basis for its claim for payment
and intends to vigorously oppose any Rockefeller claim for payment related to these matters. In
the letter, Rockefeller also stated its rejection of the Companys notice sent to Rockefeller on
August 9, 2007 to terminate the September 30, 1992 license agreement between us and Rockefeller.
Termination of Manufacturing and Packaging Agreement
On April 30, 2007, we entered into a letter agreement with Catalent Pharma Solutions (formerly
Cardinal Health PTS, LLC), or Catalent, which terminated, without penalty to either party, our
manufacturing and packaging agreement and certain quality agreements with Catalent. In connection
with the termination, we and Catalent agreed that certain provisions of the manufacturing and
packaging agreement would survive and Catalent would continue to perform limited services.
Catalent will also continue to manufacture LGD-4665 capsules for us pursuant to the terms of a
separate agreement. The letter agreement also contained a mutual general release of all claims
arising from or related to the manufacturing and packaging agreement.
In connection with our previously announced sale of the AVINZA product line to King
Pharmaceuticals, we and King Pharmaceuticals agreed that the manufacturing and packaging agreement
would not be assigned or transferred to King Pharmaceuticals, and that we would be responsible for
winding down the contract and any resulting liabilities. We paid $0.3 million to a former
executive in connection with the negotiation of the termination of the Catalent manufacturing and
packaging agreement. We do not expect the costs of winding down the Catalent agreement to be
material.
39
Sale of AVINZA Product Line
On September 6, 2006, Ligand and King entered into a purchase agreement, or AVINZA Purchase
Agreement, pursuant to which King agreed to acquire all of our rights in and to AVINZA in the
United States, its territories and Canada, including, among other things, all AVINZA inventory,
records and related intellectual property, and assume certain liabilities as set forth in the
AVINZA Purchase Agreement, which we collectively refer to as the Transaction. In addition, subject
to the terms and conditions of the AVINZA Purchase Agreement, King agreed to offer employment
following the closing of the Transaction, or Closing, to certain of our existing AVINZA sales
representatives or otherwise reimburse us for certain agreed upon severance arrangements offered to
any such non-hired representatives. The Transaction closed on February 26, 2007.
Pursuant to the terms of the AVINZA Purchase Agreement, we received $289.4 million in net cash
proceeds, which represents the purchase price of $247.8 million, which is net of certain inventory
adjustments of approximately $17.2 million as set forth in the AVINZA Purchase Agreement, as
amended, plus approximately $49.1 million in reimbursement of payments previously made to Organon
Pharmaceuticals USA Inc., or Organon, (See Organon Co-promote Termination below) and others.
Additionally, the net proceeds are less $15.0 million that was funded into an escrow account to
support potential indemnity claims by King following the Closing. Of the escrowed amounts not
required for claims to King, 50% of the then existing amount was released on August 26, 2007 with
the remaining available balance to be released on February 26, 2008. King also assumed our
co-promote termination obligation to make payments to Organon based on net sales of AVINZA
(approximately $93.2 million as of February 26, 2007). As Organon has not consented to the legal
assignment of the co-promote termination obligation from Ligand to King, we remain liable to
Organon in the event of Kings default of this obligation. We also incurred approximately $6.6
million in transaction fees and other costs associated with the sale that are not reflected in the
net cash proceeds. This amount includes approximately $3.6 million for investment banking services
and related expenses. We disputed the amount of the fees owed to the investment banking firm and
as a result, the parties agreed to settle the matter for $3.0 million, which was paid in June 2007.
In addition to the assumption of existing royalty obligations, King is required to pay us a
15% royalty on AVINZA net sales during the first 20 months after Closing. Subsequent royalty
payments will be based upon calendar year net sales. If calendar year net sales are less than
$200.0 million, the royalty payment will be 5% of all net sales. If calendar year net sales are
greater than $200.0 million, the royalty payment will be 10% of all net sales less than $250.0
million, plus 15% of net sales greater than $250.0 million. Royalty revenues were $5.2 million and
$6.6 million for the three and nine months ended September 30, 2007, respectively.
In connection with the Transaction, King committed to loan us, at our option, $37.8 million,
to be used to pay a co-promote termination obligation to Organon which was due October 15, 2006.
This loan was drawn, and the $37.8 million co-promote liability settled in October 2006. Amounts
due under the loan were subject to certain market terms, including a 9.5% interest rate. In
addition, and as a condition of the $37.8 million loan received from King, $38.6 million of the
funds received from Eisai was deposited into a restricted account to be used to repay the loan to
King, plus interest. We repaid the loan plus interest on January 8, 2007. Pursuant to the AVINZA
Purchase Agreement, King refunded the interest to us on the Closing Date.
Also on September 6, 2006, we entered into a contract sales force agreement (the Sales Call
Agreement) with King, pursuant to which King agreed to conduct a sales detailing program to
promote the sale of AVINZA for an agreed upon fee, subject to the terms and conditions of the Sales
Call Agreement. Pursuant to the Sales Call Agreement, King agreed to perform certain minimum
monthly product details (i.e. sales calls), which commenced effective October 1, 2006 and continued
until the Closing Date. Co-promotion expense recognized under the Sales Call Agreement for the
three and nine months ended September 30, 2007 was zero and $2.8 million, respectively, and is
included in results of discontinued operations. The amount due to King under the Sales Call
Agreement as of September 30, 2007 was approximately $1.8 million. The Sales Call Agreement
terminated effective on the Closing Date.
40
Organon Co-Promote Termination
In February 2003, we entered into an agreement for the co-promotion of AVINZA with Organon
Pharmaceuticals USA Inc., or Organon. Subsequently, in January 2006, we signed an agreement with
Organon that terminated the AVINZA co-promotion agreement between the two companies and returned
AVINZA rights to Ligand. The termination was effective as of January 1, 2006; however, the parties
agreed to continue to cooperate during a transition period that ended September 30, 2006, or
Transition Period, to promote the product. The Transition Period co-operation included a minimum
number of product sales calls per quarter as well as the transition of ongoing promotions, managed
care contracts, clinical trials and key opinion leader relationships to Ligand. During the
Transition Period, we paid Organon an amount equal to 23% of AVINZA net sales as reported. We also
paid and were responsible for the design and execution of all AVINZA clinical, advertising and
promotion expenses and activities.
Additionally, in consideration of the early termination and return of rights to AVINZA under
the terms of the agreement, we unconditionally paid Organon $37.8 million in October 2006. We also
agreed to and paid Organon $10.0 million in January 2007, in consideration of the minimum sales
calls during the Transition Period. In addition, following the Transition Period, we agreed to
make quarterly royalty payments to Organon equal to 6.5% of AVINZA net sales through December 31,
2012 and thereafter 6.0% through patent expiration, currently anticipated to be November of 2017.
In connection with the AVINZA sale transaction, King assumed our obligation to make payments
to Organon based on net sales of AVINZA (the fair value of which approximated $93.2 million as of
February 26, 2007). As Organon has not consented to the legal assignment of the co-promote
termination obligation from us to King, we remain liable to Organon in the event of Kings default
of this obligation. Therefore, we recorded an asset on February 26, 2007 to recognize Kings
assumption of the obligation, while continuing to carry the co-promote termination liability in our
consolidated financial statements to recognize our legal obligation as primary obligor to Organon
as required under SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities. This asset represents a non-interest bearing receivable for future
payments to be made by King and is recorded at its fair value. As of September 30, 2007 and
thereafter, the asset and liability will remain equal and adjusted each quarter for changes in the
fair value of the obligation. The receivable will be assessed on a quarterly basis for impairment
(e.g. in the event King defaults on the assumed obligation to pay Organon). On a quarterly basis,
management also reviews the carrying value of the co-promote termination liability. Due to
assumptions and judgments inherent in determining the estimates of future net AVINZA sales through
November 2017, the actual amount of net AVINZA sales used to determine the amount of the liability
for a particular period may be materially different from current estimates. Any resulting changes
to the co-promote termination liability will have a corresponding impact on the co-promote
termination asset. As of September 30, 2007, the fair value of the co-promote termination
liability was determined using a discount rate of 15%, the discount rate used to initially value
this component of the termination liability.
Sale of Oncology Product Line
On September 7, 2006, we, Eisai Inc., a Delaware corporation and Eisai Co., Ltd., a Japanese
company, which we collectively refer to as Eisai, entered into a purchase agreement, or Oncology
Purchase Agreement pursuant to which Eisai agreed to acquire all of our worldwide rights in and to
our oncology products, including, among other things, all related inventory, equipment, records and
intellectual property, and assume certain liabilities, or Oncology Product Line, as set forth in
the Oncology Purchase Agreement. The Oncology Product Line included our four marketed oncology
drugs: ONTAK, Targretin capsules, Targretin gel and Panretin gel. Pursuant to the Oncology
Purchase Agreement, at closing on October 25, 2006, we received approximately $185.0 million in net
cash proceeds which is net of $20.0 million that was funded into an escrow account to support any
indemnification claims made by Eisai following the closing of the sale, and Eisai assumed certain
liabilities. Of the escrowed amounts, $10.0 million was released to us on April 25, 2007, and the
remaining $10.0 million was released to us on October 25, 2007. We incurred approximately $1.7
million of transaction fees and costs associated with the sale that are not reflected in the net
cash proceeds.
41
Additionally, $38.6 million of the proceeds received from Eisai were deposited into a
restricted account to repay a loan received from King, the proceeds of which were used to pay our
co-promote termination obligation to Organon in October 2006. Such amounts were released and the
loan repaid to King in January 2007.
In connection with the Oncology Purchase Agreement with Eisai, we entered into a transition
services agreement whereby we agreed to perform certain transition services for Eisai, in order to
effect, as rapidly as practicable, the transition of purchased assets from Ligand to Eisai. In
exchange for these services, Eisai paid us a monthly service fee through June 25, 2007. Fees
earned under the transition services agreement during the three and nine months ended September 30,
2007, which were recorded as an offset to operating expenses, were zero and $2.7 million,
respectively.
Return of Cash to Shareholders/Equitable Adjustment of Employee Stock Options
On March 22, 2007, we declared a cash dividend on our common stock of $2.50 per share. As we
have an accumulated deficit, the dividend was recorded as a charge against additional paid-in
capital in the first quarter of 2007. The aggregate amount of $252.7 million was paid on April 19,
2007 to shareholders of record as of April 5, 2007. In addition to the cash dividend, the Board of
Directors authorized up to $100.0 million in share repurchases over the subsequent 12 months. For
the three months ended September 30, 2007, we repurchased 1.6 million shares of our common stock
totaling $10.1 million. For the nine months ended September 30, 2007, we repurchased 5.4 million
shares of our common stock totaling $35.5 million. During October 2007, we repurchased an
additional 0.4 million shares of our common stock totaling $2.2 million.
In February 2007, our shareholders approved a modification to the 2002 Stock Incentive Plan,
or 2002 Plan, to allow equitable adjustments to be made to options outstanding under the 2002 Plan.
Effective April 2007, following the ex-dividend date, we reduced the exercise price by $2.50, (or
to par value for those options with an exercise price below $2.50 per share) as an equitable
adjustment, for all options then outstanding under the 2002 Plan. Under the requirements of SFAS
123(R), we will recognize approximately $2.0 million of stock compensation expense in connection
with the equitable adjustment, effective March 28, 2007, the date the Compensation Committee of our
Board of Directors approved the equitable adjustment. For the three and nine months ended
September 30, 2007, $0.01 million and $1.8 million of stock compensation expense was recognized,
respectively, and the remaining $0.2 million will be recognized over the remaining vesting period
of the options which were unvested as of the modification date.
The Salk Institute for Biological Studies Allegations
In March 2007, we received a letter from legal counsel to The Salk Institute for Biological
Studies (Salk) alleging that we owe Salk royalties on prior product sales of Targretin as well as
a percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai Inc. (New Jersey) that
are attributable to Targretin with respect to our sale of the Oncology Product Line to Eisai that
was completed in October 2006. Salk alleges it is owed at least 25% of the consideration paid by
Eisai for that portion of our oncology product line and associated assets attributable to
Targretin. In an April 11, 2007 request for mediation, Salk repeated these claims and asserted
additional claims that allegedly increase the amount of royalty buy-out payments. Representatives
from Ligand and Salk attended a mediation hearing in June 2007, which left the matter unresolved.
Salk filed a demand for arbitration in July 2007 with the American Arbitration Association, seeking
at least $22 million for alleged breach of contract based on Salks theory that it is entitled to a
portion of the money paid by Eisai to Ligand for Targretin related assets. We have reviewed these
matters and do not believe we have financial obligations to Salk pertaining to Targretin or these
claims. Accordingly, we do not believe that Salk has a valid basis for its claim and we intend to
vigorously oppose any Salk claim for payment related to these matters. The Company has raised a
counterclaim in the arbitration with Salk seeking either a refund of the two $1.1 million
lasofoxifene related payments or an offset against any award that may be granted to Salk. The
arbitration with Salk is ongoing.
Appointment of New CEO/Change in Board of Directors
On March 1, 2007, we announced the resignation of directors John Groom, Irving S. Johnson,
Ph.D., Daniel Loeb, Carl C. Peck, M.D. and Brigette Roberts, M.D. and the appointment of four new
directors, John L. Higgins,
42
our President and Chief Executive Officer, Todd C. Davis, Elizabeth M. Greetham and David M.
Knott. We subsequently announced the resignation of director Alexander Cross effective March 17,
2007.
On August 1, 2006, we announced that current director Henry F. Blissenbach had been named
Chairman and interim Chief Executive Officer. We agreed to pay Dr. Blissenbach $40,000 per month,
commencing August 1, 2006 for his services as Chairman and interim Chief Executive Officer. In
addition, Dr. Blissenbach was eligible to receive incentive compensation of up to 50% of his base
salary, but not more than $100,000, based upon his performance of certain objectives incorporated
within the employment agreement which we and Dr. Blissenbach entered into. As those performance
objectives were achieved, we paid the $100,000 in incentive compensation to Dr. Blissenbach in
February 2007. Also, Dr. Blissenbach received a stock option grant to purchase 150,000 shares of
our common stock at an exercise price of $6.70 per share (adjusted to reflect the March 22, 2007
equitable adjustment of employee stock options). These stock options vested upon the appointment
of a new chief executive officer in January 2007. Dr. Blissenbach ceased to be a member of our
board of directors effective May 31, 2007. Under the original terms of his stock option agreement,
Dr. Blissenbach may exercise his option for a period of three months following the date of
cessation of his service on our board of directors. In July 2007, the compensation committee
extended the period of time for which such option is to remain exercisable, but only with respect
to the purchase of 25,000 shares of the underlying common stock such that Dr. Blissenbach would
have three years to exercise his option to purchase such 25,000 shares. As a result of this
modification, we recorded compensation expense of $0.06 million for the three and nine months ended
September 30, 2007. The option to purchase the remaining 125,000 shares expired 90 days after the
cessation of Dr. Blissenbachs service as a member of our board of directors. Finally, we
reimbursed Dr. Blissenbach for all reasonable expenses incurred in discharging his duties as
interim Chief Executive Officer, including, but not limited to commuting costs to San Diego and
living and related costs during the time he spent in San Diego.
On January 15, 2007, we announced that John L. Higgins had joined us as Chief Executive
Officer and President. Mr. Higgins succeeded Dr. Blissenbach, who continued to serve as Chairman
of the Board of Directors until March 1, 2007.
Reductions in Workforce
In December 2006, and following the sale of our Oncology Product Line to Eisai, we entered
into a plan to eliminate 40 employee positions, across all functional areas, which were no longer
deemed necessary considering our decision to sell our commercial assets. Additionally, we
terminated 23 AVINZA sales representatives and regional business managers who were not offered
positions with King or declined Kings offer of employment. The affected employees were informed
of the plan in December 2006 with an effective termination date of January 2, 2007. In connection
with the termination plan, we recognized operating expenses of approximately $2.9 million in the
fourth quarter of 2006, comprised of one-time severance benefits of $2.3 million, stock
compensation of $0.3 million, and other costs of $0.3 million. The stock compensation charge
resulted from the accelerated vesting and extension of the exercise period of stock options in
accordance with severance arrangements of certain senior management members. We paid $0.5 million
in December 2006 and the remaining balance in January 2007.
On January 31, 2007, we announced a restructuring plan calling for the elimination of
approximately 204 positions across all functional areas. This reduction was made in connection
with our efforts to refocus us, following the sale of our commercial assets, as a smaller, highly
focused research and development and royalty-driven biotech company. Associated with the
restructuring and refocused business model, several of our then executive officers stepped down
including our Chief Financial Officer, Chief Scientific Officer and General Counsel. In connection
with the termination of these officers and the payment of severance, we entered into one-year
consulting agreements with each officer at hourly rates commensurate with the officers salary
compensation in effect as of the date of termination. Amounts owed to these officers for services
provided during the nine months ended September 30, 2007 were not material. We also announced that
our primary operations are expected to be
43
consolidated into one building with the goal to sublet unutilized space. In connection with
the restructuring, we recorded severance and other related charges in the first quarter of 2007
totaling $10.2 million, comprised of one-time severance benefits of $7.1 million, stock
compensation of $2.3 million, and other costs of $0.8 million. Of the one-time severance benefits
of $7.1 million, $2.1 million is included in general and administrative expenses, $4.4 million is
included in research and development expenses, and $0.6 million is included in discontinued
operations. Of the stock compensation charges of $2.3 million, $1.0 million is included in general
and administrative expenses and $1.3 million is included in research and development expenses. We
recorded severance and other related charges in the second quarter of 2007 totaling $1.0 million,
comprised of one-time severance benefits of $0.9 million and stock compensation of $0.1 million.
Of the one-time severance benefits $0.7 million is included in general and administrative expenses
and $0.2 million is included in research and development expenses. All of the stock compensation
charges are included in general and administrative expenses. We recorded severance charges in the
third quarter of 2007 totaling $0.02 million, which relate to one-time severance benefits and are
included in general and administrative expenses. The stock compensation charges result from the
accelerated vesting and extension of the exercise period of stock options in accordance with
severance arrangements of certain senior management members.
Sale and Leaseback of Premises
On October 25, 2006, we, along with our wholly-owned subsidiary Nexus Equity VI, LLC, or
Nexus, entered into an agreement with Slough Estates USA, Inc., or Slough, for the sale of our real
property located in San Diego, California for a purchase price of approximately $47.6 million.
This property, with a net book value of approximately $14.5 million, includes one building totaling
approximately 82,500 square feet, the land on which the building is situated, and two adjacent
vacant lots. As part of the sale transaction, we agreed to leaseback the building for a period of
15 years. In connection with the sale transaction, on November 6, 2006, we also paid off the
existing mortgage on the building of approximately $11.6 million. The early payment triggered a
prepayment penalty of approximately $0.4 million. The sale transaction subsequently closed on
November 9, 2006.
Under the terms of the lease, we pay a basic annual rent of $3.0 million (subject to an annual
fixed percentage increase, as set forth in the agreement), plus a 1% annual management fee,
property taxes and other normal and necessary expenses associated with the lease such as utilities,
repairs and maintenance, etc. We have the right to extend the lease for two five-year terms and
the first right of refusal to lease, at market rates, any facilities built on the sold lots.
In accordance with SFAS 13, Accounting for Leases, we recognized an immediate pre-tax gain on
the sale transaction of approximately $3.1 million in the fourth quarter of 2006 and deferred a
gain of approximately $29.5 million on the sale of the building. The deferred gain is recognized
on a straight-line basis over the 15 year term of the lease at a rate of approximately $2.0 million
per year.
Employee Retention Agreements and Severance Arrangements
In March 2006, we entered into letter agreements with approximately 67 of our key employees,
including a number of our executive officers. In September 2006, we entered into letter agreements
with ten additional employees and modified existing agreements with two employees. These letter
agreements provided for certain retention or stay bonus payments to be paid in cash under specified
circumstances as an additional incentive to remain employed in good standing with us through
December 31, 2006. The Compensation Committee of the Board of Directors approved our entry into
these agreements. In accordance with SFAS 146, Accounting for Costs Associated with Exit or
Disposal Activities, the cost of the plan was ratably accrued over the term of the agreements.
Since the retention or stay bonus payments generally vested at the end of 2006 and the total payments
to employees was paid in January 2007, we recognized approximately $2.6 million of expense under
the plan in 2006 including $1.0 million and $2.1 million, respectively, for the three and nine
months ended September 30, 2006.
Additionally, in October 2006, we implemented a 2006 Employee Severance Plan for those
employees who were not covered by another severance arrangement. The plan provided that if such an
employee was involuntarily terminated without cause, and not offered a similar or better job by one
of the purchasers of our product lines (i.e. King or Eisai) such employee would be eligible for severance benefits. The benefits consist
of two months salary,
44
plus one week of salary for every full year of service with us plus payment
of COBRA health care coverage premiums for that same period.
In August 2007, the Compensation Committee of our Board of Directors approved and ratified
change of control agreements with our executive officers and certain members of our
management. In the event the employment of any of our executive officers is involuntarily
terminated in connection with a change of control of the employment of the Company, such person,
with the exception of the Chief Executive Officer, will receive one year of salary and COBRA health
care benefits plus the maximum target bonus for the year. In the event the Chief Executive
Officers employment is involuntarily terminated in connection with a change of control of the
Company, he will receive two years of salary and COBRA health care benefits plus two times the
maximum target bonus for the year. The amounts will be payable in a lump sum following
the termination of employment. The change of control agreements also accelerate the
vesting of all outstanding unvested stock awards and provide that the stock awards may be exercised
until nine months after termination or such longer period as may be specified in the applicable
stock award agreement, except that no stock award will remain exercisable beyond the original
outside expiration date of such stock award.
45
Results of Operations
Total revenues for the three and nine months ended September 30, 2007 were $5.5 million and
$7.1 million compared to zero and $4.0 million, respectively, for the same 2006 periods. Operating
loss from continuing operations for the three and nine months ended September 30, 2007 was $8.7
million and $52.1 million compared to $22.5 million and $54.8 million, respectively, for the same
2006 periods. Loss from continuing operations for the three and nine months ended September 30,
2007 was $4.9 million and $29.4 million compared to $22.2 million and $53.0 million, respectively,
for the same 2006 periods.
AVINZA Royalty Revenue
As discussed under Recent Developments Sale of AVINZA Product Line, in connection with
the sale of AVINZA, King is required to pay us a royalty on net sales of AVINZA. In accordance
with the AVINZA Purchase Agreement, royalties are required to be reported and paid to us within 45
days of quarter-end during the 20 month period following the closing of the sale transaction
(February 26, 2007). Thereafter, royalties will be paid on a calendar year basis. Such royalties
are recognized in the quarter reported. Since there is a one quarter lag from when King recognizes
AVINZA net sales to when King reports those sales and the corresponding royalties to us, we
recognized AVINZA royalty revenues beginning in the second quarter of 2007. Royalty revenues were
$5.2 million and $6.6 million for the three and nine months ended September 30, 2007, respectively.
Collaborative Research and Development and Other Revenues
Collaborative research and development and other revenues for the three and nine months ended
September 30, 2007 were $0.3 and $0.5 million compared to zero and $4.0 million, respectively, for
the same 2006 periods. Collaborative research and development and other revenues include
reimbursement for ongoing research activities, earned development milestones, and recognition of
prior years up-front fees previously deferred in accordance with SAB No. 101, Revenue Recognition,
as amended by SAB 104.
A comparison of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Collaborative research and development |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,678 |
|
Development milestones and other |
|
|
250 |
|
|
|
|
|
|
|
485 |
|
|
|
2,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
250 |
|
|
$ |
|
|
|
$ |
485 |
|
|
$ |
3,977 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development milestones for the nine months ended September 30, 2007 reflect $0.5 million of
milestones earned from Wyeth, which compares to a $2.0 million milestone earned from
GlaxoSmithKline in connection with the commencement of Phase III studies of Promacta and $0.3
million earned from Wyeth in the 2006 period. Collaborative research and development revenues for
the nine months ended September 30, 2006 represent fees earned under our collaboration agreement
with TAP, which concluded in June 2006.
46
Research and Development Expenses
Research and development expenses were $9.8 million and $34.2 million for the three and nine
months ended September 30, 2007 compared to $10.2 million and $28.7 million, respectively, for the
same 2006 periods. The major components of research and development expenses are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30 |
|
|
September 30 |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Research performed under collaboration agreements |
|
$ |
¾ |
|
|
$ |
¾ |
|
|
$ |
¾ |
|
|
$ |
1,968 |
|
Internal research programs |
|
|
4,642 |
|
|
|
5,631 |
|
|
|
16,908 |
|
|
|
15,522 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research |
|
|
4,642 |
|
|
|
5,631 |
|
|
|
16,908 |
|
|
|
17,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total development |
|
|
5,196 |
|
|
|
4,528 |
|
|
|
17,283 |
|
|
|
11,174 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
9,838 |
|
|
$ |
10,159 |
|
|
$ |
34,191 |
|
|
$ |
28,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses for the three and nine months ended September 30, 2007
include one-time severance benefits and stock compensation charges of zero and $5.9 million,
respectively, incurred in connection with our restructuring and one-time stock compensation charges
of zero and $0.8 million, respectively, incurred in connection with the equitable adjustment of
stock options as discussed under Recent Developments above.
Spending for research expenses was $4.7 million and $16.9 million for the three and nine
months ended September 30, 2007 compared to $5.6 million and $17.5 million, respectively, for the
same 2006 periods. Excluding the impact of one-time severance benefits and stock compensation
charges, the decrease in internal research program expenses for the three and nine months ended
September 30, 2007 compared to the same 2006 periods reflects reduced costs primarily due to lower
headcount related expenses in connection with our restructuring. The nine months ended September
30, 2007 compared to the same 2006 period reflects increased research performed in the area of
thrombopoietin (TPO) agonists.
Spending for development expenses was $5.2 million and $17.3 million for the three and nine
months ended September 30, 2007 compared to $4.5 million and $11.2 million, respectively, for the
same 2006 periods. Excluding the impact of one-time severance benefits and stock compensation
charges, spending for development expenses for the three and nine months ended September 30, 2007
increased compared to the same 2006 periods primarily reflecting increased spending on LGD-4665
TPO, our leading drug candidate in this area which is in Phase I clinical trials.
47
A summary of our significant internal research and development programs as of September 30,
2007 is as follows:
|
|
|
|
|
Program |
|
Disease/Indication |
|
Development Phase |
LGD-4665 (Thrombopoietin oral
mimetic)
|
|
Idiopathic Thrombocytopenia
Purpura; myelodysplastic
syndrome, Hepatitis C, other
thrombocytopenias
|
|
Phase I |
|
|
|
|
|
Selective androgen receptor modulators,
(agonists)
|
|
Hypogonadism,osteoporosis,
sexual dysfunction, frailty,
cachexia
|
|
Pre-clinical |
|
|
|
|
|
Selective glucocorticoid receptor
modulators
|
|
Inflammation, cancer
|
|
Research |
|
|
|
|
|
Selective androgen receptor modulators,
(antagonists)
|
|
Prostate cancer
|
|
Research |
We do not provide forward-looking estimates of costs and time to complete our ongoing research
and development projects, as such estimates would involve a high degree of uncertainty.
Uncertainties include our ability to predict the outcome of complex research, our ability to
predict the results of clinical studies, regulatory requirements placed upon us by regulatory
authorities such as the FDA and EMEA, our ability to predict the decisions of our collaborative
partners, our ability to fund research and development programs, competition from other entities of
which we may become aware in future periods, predictions of market potential from products that may
be derived from our research and development efforts, and our ability to recruit and retain
personnel or third-party research organizations with the necessary knowledge and skills to perform
certain research. Refer to Item 1A. Risk Factors for additional discussion of the uncertainties
surrounding our research and development initiatives.
General and Administrative Expenses
General and administrative expenses were $4.9 million and $26.5 million for the three and nine
months ended September 30, 2007 compared to $12.3 million and $30.1 million, respectively, for the
same 2006 periods. The decreases are due to lower headcount in connection with our restructuring
and reduced legal costs (as we incurred significant costs during 2006 in connection with the
ongoing SEC investigation, shareholder litigation and our strategic initiative process) and
consultant fees incurred in connection with our 2006 SOX compliance program. General and
administrative expenses for the nine months ended September 30, 2007 include one-time severance
benefits and stock compensation charges of approximately $3.9 million incurred in connection with
our restructuring and one-time stock compensation charges of $1.0 million incurred in connection
with the equitable adjustment of stock options discussed under Recent Developments above.
General and administrative expenses for the three and nine months ended September 30, 2007 also
include approximately $0.5 million and $2.4 million, respectively, of legal and related costs
incurred in connection with the ongoing SEC investigation of our financial statement restatement
(See Part II, Item 1 Legal Proceedings).
Accretion of Deferred Gain on Sale Leaseback
On October 25, 2006, we, along with our wholly-owned subsidiary Nexus, entered into an
agreement with Slough for the sale of our real property located in San Diego, California for a
purchase price of approximately $47.6 million. This property, with a net book value of
approximately $14.5 million, includes one building totaling approximately 82,500 square feet, the
land on which the building is situated, and two adjacent vacant lots. As part of the sale
transaction, we agreed to lease back the building for a period of 15 years. The sale transaction
subsequently closed on November 9, 2006.
In accordance with SFAS 13, Accounting for Leases, we recognized an immediate pre-tax gain on
the sale transaction of approximately $3.1 million in the fourth quarter of 2006 and deferred a
gain of approximately $29.5 million on the sale of the building. The deferred gain is recognized
as an offset to operating expense on a straight-
48
line basis over the 15 year term of the lease at a rate of approximately $2.0 million per year.
The accretion of the deferred gain was $0.5 million and $1.5 million for the three and nine months
ended September 30, 2007, respectively.
Interest Income
Interest income was $1.5 million and $7.4 million for the three and nine months ended
September 30, 2007 compared to $0.6 million and $1.7 million, respectively, for the same 2006
periods. The increase for the three and nine months ended September 30, 2007 when compared to the
same 2006 periods is primarily due to higher cash and investment balances as a result of the
proceeds from the sales of the Oncology Product Line on October 25, 2006 and the AVINZA Product
Line on February 26, 2007 discussed under Recent Developments above.
Income Taxes
We had losses from continuing operations and income from discontinued operations for the three
and nine months ended September 30, 2007. In accordance with SFAS No. 109, Accounting for Income
Taxes, the income tax benefit generated by the loss from continuing operations for the three and
nine months ended September 30, 2007 was $2.4 million and $15.8 million, respectively. This income
tax benefit captures the deemed use of losses from continuing operations used to offset the income
and gain from our AVINZA product line that was sold on February 26, 2007.
Net income tax benefit combining both continuing and discontinued operations was $3.7 million
and a net income tax expense of $10.0 million for the three and nine months ended September 30,
2007, respectively. The income tax benefit for the three months ended September 30, 2007 reflects
the deemed use of losses from continuing operations reflected in the application of the annual
effective tax rate which is offset, in part, by the income tax expense recorded discretely most
significantly in the first quarter from the sale of the Companys AVINZA product line on February
26, 2007. The income tax benefit of $1.4 million recorded discretely in the third quarter from the
sale of the AVINZA product line reflects a reduction in income tax that was recorded in previous
quarters of 2007. The income tax expense for the nine months ended September 30, 2007 reflects the
net tax due on taxable income that was not fully offset by net operating loss and research and
development credit carryforwards due to federal and state alternative minimum tax requirements.
This tax expense will be offset in part by a tax benefit in the fourth quarter. This fourth
quarter income tax benefit will reflect the deemed use of losses from continuing operations used to
offset the income and gain from the Companys AVINZA product line. Net income tax expense
combining both continuing and discontinued operations was $0.02 million and $0.1 million for the
three and nine months ended September 30, 2006, respectively.
Discontinued Operations
Oncology Product Line
On September 7, 2006, we and Eisai entered into the Oncology Purchase Agreement pursuant to
which Eisai agreed to acquire all of our worldwide rights in and to our oncology products, or
Oncology Product Line, including, among other things, all related inventory, equipment, records and
intellectual property, and assume certain liabilities, or Oncology Product Line as set forth in the
Oncology Purchase Agreement. The Oncology Product Line included our four marketed oncology drugs:
ONTAK, Targretin capsules, Targretin gel and Panretin gel. Pursuant to the Oncology Purchase
Agreement, at closing on October 25, 2006, we received approximately $185.0 million in net cash
proceeds, which is net of $20.0 million that was funded into an escrow account to support any
indemnification claims made by Eisai following the closing of the sale. Eisai also assumed certain
liabilities. Of the escrowed amounts, $10.0 million was released to us on April 25, 2007, and the
remaining $10.0 million, plus interest of approximately $0.8 million, was released to us on October
25, 2007. We also recorded approximately $1.7 million in transaction fees and costs associated
with the sale that are not reflected in net cash proceeds. We recorded a pre-tax gain on the sale
of $135.8 million in the fourth quarter of 2006. In the first quarter of 2007, we recorded a $0.1
million pre-tax reduction to the gain on the sale due to subsequent changes in certain estimates of
assets and liabilities recorded as of the sale date. In the second quarter of 2007, we recognized a
$10.0 million pre-tax gain resulting from the release of funds from the escrow account partially
offset by $0.1 million pre-tax loss due
to subsequent changes in certain estimates of assets and liabilities recorded as of the sale
date. In the third quarter of 2007, we recorded a $2.1 million pre-tax reduction to the gain on
the sale due to subsequent changes in certain estimates of assets and liabilities recorded as of
the sale date.
Additionally, $38.6 million of the proceeds received from Eisai were deposited into an escrow
account to repay a loan received from King Pharmaceuticals, Inc., or King, the proceeds of which
were used to pay our co-promote termination obligation to Organon in October 2006. The escrow
amounts were released and the loan repaid to King in January 2007.
In connection with the Oncology Purchase Agreement with Eisai, we entered into a transition
services agreement whereby we agreed to perform certain transition services for Eisai, in order to
effect, as rapidly as practicable, the transition of purchased assets from Ligand to Eisai. In
exchange for these services, Eisai paid us a monthly service fee through June 25, 2007. Fees
earned under the transition services agreement during the three and nine months ended September 30,
2007, which were recorded as an offset to operating expenses, were zero and $2.7 million,
respectively.
Prior to the Oncology sale, we recorded accruals for rebates, chargebacks, and other discounts
related to Oncology products when product sales were recognized as revenue under the sell-through
method. Upon the Oncology sale, we accrued for rebates, chargebacks, and other discounts related
to Oncology products in the distribution channel which had not sold-through at the time of the
Oncology sale and for which we retained the liability subsequent to the Oncology sale. Our
accruals for Oncology rebates, chargebacks, and other discounts total $1.1 million as of September
30, 2007 and is included in accrued liabilities in the accompanying condensed consolidated balance
sheet.
Additionally, and pursuant to the terms of the Oncology Purchase Agreement, we retained the
liability for returns of product from wholesalers that had been sold by us prior to the close of
the transaction. Accordingly, as part of the accounting for the gain on the sale of the Oncology
Product Line, we recorded a reserve for Oncology product returns. Under the sell-through revenue
recognition method, we previously did not record a reserve for returns from wholesalers. Our
reserve for Oncology returns was $5.4 million as of September 30, 2007 and is included in accrued
liabilities in the accompanying condensed consolidated balance sheet.
AVINZA Product Line
On September 6, 2006, we and King entered into the AVINZA Purchase Agreement pursuant to which
King agreed to acquire all of our rights in and to AVINZA in the United States, its territories and
Canada, including, among other things, all AVINZA inventory, records and related intellectual
property, and assume certain liabilities as set forth in the AVINZA Purchase Agreement, which we
collectively refer to as the Transaction. In addition, King, subject to the terms and conditions
of the AVINZA Purchase Agreement, agreed to offer employment following the closing of the
Transaction, or Closing, to certain of our existing AVINZA sales representatives or otherwise
reimburse us for agreed upon severance arrangements offered to any such non-hired representatives.
Pursuant to the AVINZA Purchase Agreement, at Closing on February 26, 2007, or Closing Date,
we received $280.4 million in net cash proceeds, which is net of $15.0 million that was funded into
an escrow account to support potential indemnification claims made by King following the Closing.
The purchase price reflected a reduction of $12.7 million due to the preliminary estimate of retail
inventory levels of AVINZA at the Closing Date exceeding targeted levels. After final studies and
review by King, the final retail inventory-level adjustment was determined to be $11.2 million. We
subsequently received the additional $1.5 million in sale proceeds in April 2007. The purchase
price also reflects a reduction of $6.0 million for anticipated higher cost of goods for King
related to the Catalent manufacturing and packaging agreement. At the closing, we agreed to not
assign the Catalent agreement to King, wind down the contract, and remain responsible for any
resulting liabilities. Subsequent to the closing, on April 30, 2007, we entered into a letter
agreement with Catalent which terminated, without penalty to either party, the manufacturing and
packaging agreement and certain related quality agreements with Catalent. In connection with the
termination, we and Catalent agreed that certain provisions of the manufacturing and packaging
agreement would survive and Catalent would continue to perform limited services. Catalent will
also continue to manufacture LGD-4665 capsules for us under the terms of a separate agreement. The
letter agreement with Catalent also
50
contained a mutual general release of all claims arising from or related to the manufacturing
and packaging agreement. We do not expect the costs of winding down the Catalent agreement to be
material.
The net cash received also includes reimbursement of $47.8 million for co-promote termination
payments which had previously been paid to Organon, $0.9 million of interest Ligand paid King on a
loan that was repaid in January 2007, and $0.5 million of severance expense for AVINZA sales
representatives not offered positions with King. A summary of the final net cash proceeds,
exclusive of $6.6 million in transaction costs and adjusted to reflect the final results of the
retail inventory study, is as follows (in thousands):
|
|
|
|
|
Purchase price |
|
$ |
265,000 |
|
Reimbursement of Organon payments |
|
|
47,750 |
|
Repayment of interest on King loan |
|
|
883 |
|
Reimbursement of sales representative severance costs |
|
|
453 |
|
|
|
|
|
|
|
|
314,086 |
|
|
Less retail pharmacy inventory adjustment |
|
|
(11,225 |
) |
Less cost of goods manufacturing adjustment |
|
|
(6,000 |
) |
|
|
|
|
|
|
|
296,861 |
|
Less funds placed into escrow |
|
|
(15,000 |
) |
Add funds released from escrow |
|
|
7,500 |
|
|
|
|
|
|
Net cash proceeds |
|
$ |
289,361 |
|
|
|
|
|
King also assumed our co-promote termination obligation to make payments to Organon based on
net sales of AVINZA (approximately $93.2 million as of February 26, 2007). As Organon has not
consented to the legal assignment of the co-promote termination obligation from us to King, we
remain liable to Organon in the event of Kings default of this obligation. We also incurred
approximately $6.6 million in transaction fees and other costs associated with the sale that are
not reflected in the net cash proceeds, of which $3.6 million was recognized in 2006. We
recognized approximately $3.6 million in the first quarter of 2007 for investment banking services
and related expenses. We disputed the amount of the fees owed to the investment banking firm and
as a result, the parties agreed to settle the matter for $3.0 million, which was paid in June 2007.
We recorded a pre-tax gain on the sale of $310.1 million in the first quarter of 2007. We recorded
a $0.3 million pre-tax increase to the gain on the sale in the second quarter of 2007 due to
subsequent changes in certain estimates of assets and liabilities recorded as of the sale date
partially offset by the adjustment to the investment banking fees discussed above. In the third
quarter of 2007, we recognized a $7.5 million pre-tax gain resulting from the release of funds from
the escrow account partially offset by a $0.6 million pre-tax loss due to subsequent changes in
certain estimates of assets and liabilities recorded as of the sale date.
In addition to the assumption of existing royalty obligations, King is required to pay Ligand
a 15% royalty on AVINZA net sales during the first 20 months after Closing. Subsequent royalty
payments will be based upon calendar year net sales. If calendar year net sales are less than
$200.0 million, the royalty payment will be 5% of all net sales. If calendar year net sales are
greater than $200.0 million, the royalty payment will be 10% of all net sales less than $250.0
million, plus 15% of net sales greater than $250.0 million. Royalty revenues were $5.2 million and
$6.6 million for the three and nine months ended September 30, 2007, respectively.
Also on September 6, 2006, we entered into a contract sales force agreement, or Sales Call
Agreement with King, pursuant to which King agreed to conduct a sales detailing program to promote
the sale of AVINZA for an agreed upon fee, subject to the terms and conditions of the Sales Call
Agreement. Pursuant to the Sales Call Agreement, King agreed to perform certain minimum monthly
product details (i.e. sales calls), which commenced effective October 1, 2006 and continued until
the Closing Date. The total co-promote expense incurred during the
51
first quarter of 2007 through the Closing Date was approximately $2.8 million. The amount due
to King under the Sales Call Agreement as of September 30, 2007 was approximately $1.7 million.
Prior to the AVINZA sale, we recorded accruals for rebates, chargebacks, and other discounts
related to AVINZA products when product sales were recognized as revenue under the sell-through
method. Upon the AVINZA sale, we accrued for rebates, chargebacks, and other discounts related to
AVINZA products in the distribution channel which had not sold-through at the time of the AVINZA
sale and for which we retained the liability subsequent to the sale. Our accruals for AVINZA
rebates, chargebacks, and other discounts total $1.7 million as of September 30, 2007 and are
included in accrued liabilities in the accompanying condensed consolidated balance sheet.
Additionally, and pursuant to the terms of the AVINZA Purchase Agreement, we retained the
liability for returns of product from the distribution channel that had been sold by us prior to
the close of the transaction. Accordingly, as part of the accounting for the gain on the sale of
AVINZA, we recorded a reserve for AVINZA product returns. Under the sell-through revenue
recognition method, we previously did not record a reserve for returns. Our reserve for AVINZA
returns is $10.1 million as of September 30, 2007 and is included in accrued liabilities in the
accompanying condensed consolidated balance sheet.
Summary of Results from Discontinued Operations
Income from discontinued operations before income taxes was zero and $6.0 million for the
three and nine months ended September 30, 2007 compared to income from discontinued operations
before income taxes of $7.3 million and a loss from discontinued operations before income taxes of
$120.0 million, respectively, for the same 2006 periods. There were no transactions during the
three months ended September 30, 2007. The following table summarizes results from discontinued
operations for the nine months ended September 30, 2007 included in the condensed consolidated
statements of operations (in thousands):
|
|
|
|
|
|
|
AVINZA |
|
|
|
Product |
|
|
|
Line |
|
Product sales |
|
$ |
18,256 |
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
Cost of products sold |
|
|
3,608 |
|
Research and development |
|
|
120 |
|
Selling, general and administrative |
|
|
3,709 |
|
Co-promotion |
|
|
2,814 |
|
Co-promote termination charges |
|
|
2,012 |
|
|
|
|
|
Total operating costs and expenses |
|
|
12,263 |
|
|
|
|
|
Income from operations |
|
|
5,993 |
|
Interest expense |
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
5,993 |
|
|
|
|
|
52
The following tables summarize results from discontinued operations for the three and nine
months ended September 30, 2006 included in the condensed consolidated statements of operations (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2006 |
|
|
|
Oncology |
|
|
AVINZA |
|
|
|
|
|
|
Product |
|
|
Product |
|
|
|
|
|
|
Line |
|
|
Line |
|
|
Total |
|
Product sales |
|
$ |
13,292 |
|
|
$ |
36,707 |
|
|
$ |
49,999 |
|
Collaborative research and development
and other revenues |
|
|
75 |
|
|
|
|
|
|
|
75 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
13,367 |
|
|
|
36,707 |
|
|
|
50,074 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
3,410 |
|
|
|
5,800 |
|
|
|
9,210 |
|
Research and development |
|
|
4,166 |
|
|
|
309 |
|
|
|
4,475 |
|
Selling, general and administrative |
|
|
3,722 |
|
|
|
7,792 |
|
|
|
11,514 |
|
Co-promotion |
|
|
|
|
|
|
11,776 |
|
|
|
11,776 |
|
Co-promote termination charges |
|
|
|
|
|
|
3,643 |
|
|
|
3,643 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
11,298 |
|
|
|
29,320 |
|
|
|
40,618 |
|
|
|
|
|
|
|
|
|
|
|
Income from operations |
|
|
2,069 |
|
|
|
7,387 |
|
|
|
9,456 |
|
Interest expense |
|
|
(1 |
) |
|
|
(2,171 |
)(1) |
|
|
(2,172 |
) |
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
$ |
2,068 |
|
|
$ |
5,216 |
|
|
$ |
7,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2006 |
|
|
|
Oncology |
|
|
AVINZA |
|
|
|
|
|
|
Product |
|
|
Product |
|
|
|
|
|
|
Line |
|
|
Line |
|
|
Total |
|
Product sales |
|
$ |
42,457 |
|
|
$ |
102,853 |
|
|
$ |
145,310 |
|
Collaborative research and development
and other revenues |
|
|
188 |
|
|
|
|
|
|
|
188 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
42,645 |
|
|
|
102,853 |
|
|
|
145,498 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
12,448 |
|
|
|
16,768 |
|
|
|
29,216 |
|
Research and development |
|
|
11,734 |
|
|
|
349 |
|
|
|
12,083 |
|
Selling, general and administrative |
|
|
12,688 |
|
|
|
27,940 |
|
|
|
40,628 |
|
Co-promotion |
|
|
|
|
|
|
33,656 |
|
|
|
33,656 |
|
Co-promote termination charges |
|
|
|
|
|
|
142,980 |
|
|
|
142,980 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
36,870 |
|
|
|
221,693 |
|
|
|
258,563 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
5,775 |
|
|
|
(118,840 |
) |
|
|
(113,065 |
) |
Interest expense |
|
|
(51 |
) |
|
|
(6,894 |
)(1) |
|
|
(6,945 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
5,724 |
|
|
$ |
(125,734 |
) |
|
$ |
(120,010 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
As part of the terms of the AVINZA Purchase Agreement, we were required to redeem
our outstanding convertible subordinated notes. All of the notes converted into shares of
common stock in 2006 prior to redemption. In accordance with EITF 87-24, Allocation of Interest
to Discontinued Operations, the interest on the notes was allocated to discontinued operations
because the debt was required to be repaid in connection with the disposal transaction. |
53
Product sales were zero and $18.3 million for the three and nine months ended September 30,
2007 compared to $50.0 million and $145.3 million for the same 2006 periods, respectively. Total
operating costs and expenses were zero and $12.3 million for the three and nine months ended
September 30, 2007 compared to $40.6 million and $258.6 million for the same 2006 periods,
respectively. The decrease in product sales and total operating costs and expenses for the three
and nine months ended September 30, 2007 compared to the same 2006 periods is primarily due to the
sales of the Oncology and AVINZA product lines effective October 25, 2006 and February 26, 2007,
respectively. There were no transactions during the three months ended September 30, 2007.
Co-promotion expense of zero and $2.8 million for the three and nine months ended September
30, 2007, respectively, represents fees paid to King for contract sales expenses incurred under the
Sales Call Agreement prior to the closing of the Transaction on February 26, 2007. This compares
to $11.8 million and $33.7 million of co-promotion expense recognized under our co-promotion
arrangement with Organon for the three and nine months ended September 30, 2006, respectively, that
concluded September 30, 2006 (Refer to Recent Developments Organon Co-Promote Termination).
For the three and nine months ended September 30, 2006, we recognized $3.6 million and $143.0
million, respectively, of co-promote termination costs in connection with the termination of our
AVINZA co-promote arrangement with Organon effective January 1, 2006. For the three and nine
months ended September 30, 2007, we recognized zero and $2.0 million, respectively, of co-promote
termination expense which represents the accretion of the termination liability to fair value as of
February 26, 2007, the closing of the AVINZA product line sale Transaction (Refer to Recent
Developments Organon Co-Promote Termination).
Interest expense for the three and nine months ended September 30, 2006 of $2.2 million and
$6.9 million, respectively, primarily represented interest on our then outstanding convertible
subordinated notes. As part of the terms of the AVINZA Purchase Agreement, we were required to
redeem the outstanding notes. All of the notes converted into shares of common stock in 2006 prior
to redemption. In accordance with EITF 87-24, Allocation of Interest to Discontinued Operations,
the interest on the notes was allocated to discontinued operations because the debt was required to
be repaid in connection with the disposal transaction.
Liquidity and Capital Resources
We have financed our operations through private and public offerings of our equity securities,
collaborative research and development and other revenues, issuance of convertible notes, product
sales and the subsequent sales of our commercial assets, capital and operating lease transactions,
accounts receivable factoring and equipment financing arrangements, and investment income. In
March 2007, we announced that our board of directors authorized a stock repurchase program under
Rule 10b-18 of the Securities Exchange Act of 1934, as amended, of up to $100 million of shares of
our common stock in the open market and negotiated purchases over a period of 12 months. For the
nine months ended September 30, 2007, we had repurchased 5.4 million shares of our common stock in
open market transactions at varying prices for an aggregate purchase price of approximately $35.5
million, which leaves approximately $64.5 million available for potential future repurchases of
common stock.
Working capital was $55.9 million at September 30, 2007 compared to $64.7 million at December
31, 2006. Cash, cash equivalents, short-term investments and restricted cash and investments
totaled $99.8 million as of September 30, 2007 compared to $212.5 million as of December 31, 2006.
We primarily invest our cash in United States government and investment grade corporate debt
securities. Restricted investments as of September 30, 2007 consist of certificates of deposit
held with a financial institution as collateral under equipment financing and third-party service
provider arrangements.
Based on our revised business model, we believe our currently available cash, cash
equivalents, and short-term investments as well as our current and future royalty revenues will be
sufficient to satisfy our anticipated operating and capital requirements through at least the next
twelve months. Our future operating and capital requirements will depend on many factors,
including: the pace of scientific progress in our research and development programs; the magnitude
of these programs; the scope and results of preclinical testing and clinical trials; the time and
costs involved in obtaining regulatory approvals; the costs involved in preparing, filing,
prosecuting, maintaining and enforcing patent claims; competing technological and market
developments; the amount of royalties on sales of
54
AVINZA we receive from King; and the efforts of our collaborators. We will also consider
additional equipment financing arrangements similar to arrangements currently in place.
Operating Activities
Operating activities used cash of $88.9 million for the nine months ended September 30, 2007
compared to $54.5 million for the same 2006 period. The use of cash for the nine months ended
September 30, 2007 reflects net income of $275.8 million, adjusted by $317.5 million in items to
reconcile net income to net cash used in operations. These reconciling items primarily reflect the
gain on the sale of our AVINZA Product Line of $317.3 million, the adjustment to the gain on the
sale of our Oncology Product Line of $7.7 million, the accretion of deferred gain on the sale
leaseback of the building of $1.5 million, and co-promote termination expense of $1.4 million,
partially offset by the recognition of $7.0 million of stock-based compensation expense,
depreciation and amortization of assets of $2.3 million, and the write-off of assets of $0.8
million.
The use of cash for the nine months ended September 30, 2007 is further impacted by changes in
operating assets and liabilities due primarily to decreases in accounts payable and accrued
liabilities of $45.0 million and to deferred revenue, net of $8.7 million and an increase in the
restricted indemnity account of $10.0 million, partially offset by decreases in accounts
receivable, net of $11.5 million, other current assets of $3.6 million, and inventories, net of
$0.9 million. The decreases in deferred revenue and accounts receivable are primarily due to the
AVINZA sale. The decrease in accounts payable and accrued liabilities is primarily due to the
January 2007 payment of $10.0 million in accrued fees for co-promotion services to Organon during
the co-promote transition period which terminated effective September 30, 2006, and lower headcount
costs and operational expenses following the sale of our AVINZA Product Line to King in February
2007, partially offset by an increase in accrued income taxes of $3.3 million primarily due to
income taxes owed on the gain of the AVINZA Product Line. The increase in the restricted indemnity
account is due to the funding of $10.0 million to support our existing indemnification obligations
to continuing and departing directors in connection with the ongoing SEC investigation and related
matters, less payments made.
Cash used in operating activities for the nine months ended September 30, 2006 of $54.5
million reflects a net loss of $173.1 offset by non-cash operating expenses of $16.6 million and
$102.1 million of changes in operating assets and liabilities. Non-cash operating expense in 2006
includes $4.0 million of stock compensation expense and $12.8 million of depreciation and
amortization. The use of cash for the 2006 period is further impacted by changes in operating
assets and liabilities due to decreases in deferred revenues net of $50.5 million and accounts
payable and accrued liabilities of $5.8 million, partially offset by decreases in accounts
receivable, net of $13.9 million and other current assets of $2.0 million. The reconciliation of
net loss to net cash used in operating activities for the nine months ended September 30, 2006 also
reflects the accrual of the AVINZA co-promote termination liability of $143.0 million.
Cash used in operating activities for the nine months ended September 30, 2007 includes $27.2
million used in discontinued operations compared to $13.4 million for the same 2006 period.
Investing Activities
Cash provided by investing activities for the nine months ended September 30, 2007 was $323.0
million compared to cash used in investing activities of $2.9 million for the same 2006 period.
Cash provided for the nine months ended September 30, 2007 primarily reflects proceeds from the
sale of our AVINZA Product Line of $289.4 million, the release of $10.0 million in proceeds from
escrow from the sale of the Oncology Product Line, and the decrease of restricted cash and
investments of $39.2 million, the majority of which was held in escrow as of December 31, 2006 and
released in January 2007 to repay our loan with King. The loan amount including interest was
subsequently reimbursed to us in February 2007 in connection with the closing of the AVINZA Product
Line sale to King. These amounts are partially offset by the net purchase of short-term
investments of $15.6 million. Cash used for the nine months ended September 30, 2006 primarily
reflects purchases of property and equipment of $1.6 million and the net purchase of short-term
investments of $1.4 million.
55
Cash provided by investing activities for the nine months ended September 30, 2007 includes
$299.4 million provided by discontinued operations compared to $0.02 million used in discontinued
operations for the same 2006 period.
Financing Activities
Cash used in financing activities for the nine months ended September 30, 2007 was $323.1
million compared to cash provided by financing activities of $0.6 million for the same 2006 period.
Cash used for the nine months ended September 30, 2007 primarily reflects the $252.7 million cash
dividend payment, $35.5 million in repurchases of our common stock, the repayment of debt of $37.8
million, and payments under equipment financing obligations of $1.6 million. These amounts are
partially offset by proceeds from the issuance of common stock, related primarily to the exercise
of employee stock options, of $4.3 million. Cash provided by financing activities for the nine
months ended September 30, 2006 includes proceeds from the issuance of common stock, related
primarily to the exercise of employee stock options, of $2.0 million partially offset by net
payments under equipment financing arrangements of $1.0 million and the repayment of debt of $0.3
million.
On March 22, 2007, we announced a return of cash on our common stock in the form of a $2.50
per share special cash dividend. The aggregate amount of $252.7 million was paid on April 19, 2007
to shareholders of record as of April 5, 2007. In addition to the cash dividend, the Board of
Directors authorized up to $100.0 million in share repurchases over the subsequent 12 months. For
the nine months ended September 30, 2007, we repurchased 5.4 million shares of our common stock
totaling $35.5 million. During October 2007, we repurchased an additional 0.4 million shares of
our common stock totaling $2.2 million.
None of the cash used in financing activities for the nine months ended September 30, 2007
relates to discontinued operations compared to $0.1 million used in discontinued operations for the
same 2006 period.
Certain of our property and equipment is pledged as collateral under various equipment
financing arrangements. As of September 30, 2007, $2.7 million was outstanding under such
arrangements with $1.8 million classified as current. Our equipment financing arrangements have
terms of four years with interest ranging from 7.35% to 10.11%.
On July 19, 2007, we purchased $5.0 million of commercial paper issued by Golden Key Ltd. As
this security had a stated maturity date of October 10, 2007, we classified the security as a
cash equivalent. During the third quarter of 2007, large credit rating agencies downgraded the
quality of this security. In addition, as a result of not meeting certain liquidity covenants, the
assets were assigned to a trustee who established a committee of the largest senior credit holders
to determine the next steps. Subsequently, Golden Key defaulted on its obligation to settle the
security on the stated maturity date of October 10, 2007. We do not have any further information
as to the expected resolution of this matter and cannot estimate at this time, neither as a point
estimate nor a range, the loss in value, if any, of this security. Accordingly, this security is
carried at its estimated fair value of $5.0 million on the balance sheet at September 30, 2007.
Leases and Off-Balance Sheet Arrangements
We lease certain of our office and research facilities under operating lease arrangements with
varying terms through November 2021. The agreements provide for increases in annual rents based on
changes in the Consumer Price Index or fixed percentage increases ranging from 3% to 7%.
56
Contractual Obligations
As of September 30, 2007, future minimum payments due under our contractual obligations are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
Total |
|
|
Less than 1 year |
|
|
1-3 years |
|
|
3-5 years |
|
|
After 5 years |
|
Capital lease obligations (1) |
|
$ |
2,912 |
|
|
$ |
1,971 |
|
|
$ |
941 |
|
|
$ |
|
|
|
$ |
|
|
Operating lease obligations |
|
|
68,433 |
|
|
|
4,871 |
|
|
|
10,185 |
|
|
|
10,806 |
|
|
|
42,571 |
|
Severance obligation |
|
|
89 |
|
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulting agreements |
|
|
640 |
|
|
|
640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promote termination liability (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing agreements (3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
72,074 |
|
|
$ |
7,571 |
|
|
$ |
11,126 |
|
|
$ |
10,806 |
|
|
$ |
42,571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes interest payments as follows: |
|
$ |
213 |
|
|
$ |
161 |
|
|
$ |
52 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
(2) |
|
Our co-promote termination obligation to Organon was assumed by King pursuant to the
AVINZA Purchase Agreement. However, as Organon did not consent to the legal assignment of
the obligation to King, Ligand remains liable to Organon in the event of Kings default of
the obligation. As of September 30, 2007, the total estimated amount of the obligation is
approximately $187.7 million on an undiscounted basis. |
|
(3) |
|
In May 2006, Ligand and Catalent Pharma Solutions (formerly Cardinal Health PTS, LLC),
or Catalent, entered into the First Amendment to the Manufacturing and Packaging Agreement
for the manufacturing of AVINZA. The amendment principally adjusted certain contract
dates, near-term minimum commitments and contract prices. Under the terms of the amended
agreement, we committed to minimum annual purchases ranging from $0.8 million to $1.2
million for 2006; $2.2 million to $3.3 million for 2007; and $2.4 million to $3.6 million
for 2008 through 2010. As part of the closing of the AVINZA sale transaction, we and King
agreed that the Catalent agreement would not be assigned or transferred to King and that we
would be responsible for winding down the contract and any resulting liabilities. The
contract was subsequently terminated in April 2007. We do not expect the costs of winding
down the Catalent agreement to be material. |
As of September 30, 2007, we have net open purchase orders (defined as total open purchase
orders at quarter end less any accruals or invoices charged to or amounts paid against such
purchase orders) totaling approximately $6.7 million. For the twelve months ended December 31,
2007 we plan to spend approximately $0.6 million on capital expenditures.
Critical Accounting Policies
Certain of our accounting policies require the application of management judgment in making
estimates and assumptions that affect the amounts reported in the consolidated financial statements
and disclosures made in the accompanying notes. Those estimates and assumptions are based on
historical experience and various other factors deemed to be applicable and reasonable under the
circumstances. The use of judgment in determining such estimates and assumptions is by nature,
subject to a degree of uncertainty. Accordingly, actual results could differ from the estimates
made. Management believes that the only material changes during the nine months ended September
30, 2007 to the critical accounting policies reported in the Managements Discussion and Analysis
section of our 2006 Annual Report are related to 1) revenue recognition for AVINZA royalties, 2)
AVINZA product returns and 3) co-promote termination accounting pursuant to the sale of AVINZA.
57
Revenue Recognition AVINZA Royalties
In accordance with the AVINZA Purchase Agreement, royalties are required to be reported and
paid to us within 45 days of quarter-end during the 20 month period following the closing of the
sale transaction (February 26, 2007). Thereafter, royalties will be paid on a calendar year basis.
Royalties on sales of AVINZA due from King are recognized in the quarter reported. Since there is
a one quarter lag from when King recognizes AVINZA net sales to when King reports those sales and
the corresponding royalties to us, we recognized AVINZA royalty revenues beginning in the second
quarter of 2007.
AVINZA Product Returns
In connection with the sale of the AVINZA product line to King, we retained the obligation for
returns of product that we shipped to wholesalers prior to the close of the transaction on February
26, 2007. The accrual for AVINZA product returns, which was recorded as part of the accounting for
the AVINZA sale transaction, is based on historical experience. While our obligation is for
returns of product from our wholesaler customers, retail pharmacies may also return AVINZA to the
wholesalers who in turn could return the product to us. As of September 30, 2007, we believe that
the majority of AVINZA in the distribution channel is held at the retail pharmacy level. Due to
the estimates and assumptions inherent in determining the amount of product returns, and that
following the sale of the AVINZA product line to King we will have limited visibility into the
amount of Ligand shipped product in the distribution channel, we are unable to quantify an estimate
of the reasonably likely effect of any changes to the returns accrual, including the timing of any
such changes, on our financial position. Any such changes will be recorded as a component of
discontinued operations in the period identified. For reference purposes, a 10% to 20% variance to
our estimated allowance for returns on the AVINZA products would result in an approximate $1.0
million to $2.0 million adjustment to the reserve for AVINZA product returns.
Co-Promote Termination Accounting
As part of the termination and return of co-promotion rights agreement that we entered into
with Organon in January 2006, we agreed to make quarterly payments to Organon, effective for the
fourth quarter of 2006, equal to 6.5% of AVINZA net sales through December 31, 2012 and thereafter
6% through patent expiration, currently anticipated to be November 2017. The estimated fair value
of the amounts to be paid to Organon after the termination ($95.2 million as of January 2006),
based on the future estimated net sales of the product, was recognized as a liability and expensed
as a cost of the termination as of the effective date of the agreement, January 2006.
In connection with the AVINZA sale transaction, King assumed our obligation to make payments
to Organon based on net sales of AVINZA (the fair value of which approximated $93.2 million as of
February 26, 2007). As Organon has not consented to the legal assignment of the co-promote
termination obligation from us to King, we remain liable to Organon in the event of Kings default
of this obligation. Therefore, we recorded an asset on February 26, 2007 to recognize Kings
assumption of the obligation, while continuing to carry the co-promote termination liability in our
consolidated financial statements to recognize our legal obligation as primary obligor to Organon
as required under SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities. This asset represents a non-interest bearing receivable for future
payments to be made by King and is recorded at its fair value. As of September 30, 2007 and
thereafter, the receivable and liability will remain equal and adjusted each quarter for changes in
the fair value of the obligation. On a quarterly basis, management reviews the carrying value and
assesses the co-promote termination receivable for impairment (e.g. in the event King defaults on
the assumed obligation to pay Organon). On a quarterly basis, management also reviews the carrying
value of the co-promote termination liability. Due to assumptions and judgments inherent in
determining the estimates of future net AVINZA sales through November 2017, the actual amount of
net AVINZA sales used to determine the amount of the asset and liability for a particular period
may be materially different from current estimates. Any resulting changes to the co-promote
termination liability will have a corresponding impact on the co-promote termination payments
receivable. As of September 30, 2007, the fair value of the co-promote termination liability (and
the corresponding receivable) was determined using a discount rate of 15%.
58
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
At September 30, 2007, our investment portfolio included fixed-income securities of $30.5
million. These securities are subject to interest rate risk and will decline in value if interest
rates increase. However, due to the short duration of our investment portfolio, an immediate 10%
change in interest rates is not expected to have a material impact on our financial condition,
results of operations or cash flows. At September 30, 2007, we also have certain equipment
financing arrangements with variable rates of interest. Due to the relative insignificance of such
arrangements, however, an immediate 10% change in interest rates would have no material impact on
our financial condition, results of operations, or cash flows. Declines in interest rates over
time will, however, reduce our interest income, while increases in interest rates over time will
increase our interest expense.
We do not have a significant level of transactions denominated in currencies other than U.S.
dollars and as a result we have limited foreign currency exchange rate risk. The effect of an
immediate 10% change in foreign exchange rates would have no material impact on our financial
condition, results of operations or cash flows.
59
ITEM 4. CONTROLS AND PROCEDURES
We are required to maintain disclosure controls and procedures that are designed to ensure
that information required to be disclosed in our reports under the Securities and Exchange Act of
1934, as amended, or Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms, and that such information is accumulated and
communicated to our management, including our principal executive officer and principal financial
officer, as appropriate, to ensure that information required to be disclosed by us in the reports
we file or submit under the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in applicable rules and forms.
Based on their most recent evaluation, as of the end of the period covered by this Quarterly
Report on Form 10-Q, our Chief Executive Officer and Chief Financial Officer have concluded that
our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange
Act are effective.
There was no change in our internal control over financial reporting during the most recent
fiscal quarter that has materially affected, or is reasonably likely to materially affect our
internal control over financial reporting. However, we are currently reviewing our controls and
procedures based upon the significant reduction in staff as a result of our most recent
restructuring.
60
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Securities Litigation
We were involved in several securities class action and shareholder derivative actions which
followed announcements by us in 2004 and the subsequent restatement of our financial results in
2005. In June 2006, we entered into agreements to resolve all claims by the parties in each of
these matters, including those asserted against us and the individual defendants in these cases.
Under the agreements, we agreed to pay a total of $12.2 million in cash for a release and in full
settlement of all claims. Twelve million dollars of the settlement amount and a portion of our
total legal expenses were funded by our Directors and Officers Liability insurance carrier while
the remainder of the legal fees incurred ($1.4 million for 2006) was paid by us. Of the $12.2
million settlement liability, $4.0 million was paid in October 2006 to our insurance carrier and
then disbursed to the claimants attorneys, while $8.0 million was paid in July 2006 by the
insurance carrier directly to an independent escrow agent responsible for disbursing the funds to
the class action suit claimants. As part of the settlement of the state derivative action, we
agreed to adopt certain corporate governance enhancements including the formalization of certain
Board practices and responsibilities, a Board self-evaluation process, Board and Board Committee
term limits (with gradual phase-in) and one-time enhanced independence requirements for a single
director to succeed the current shareholder representatives on the Board. Neither we nor any of
our current or former directors and officers has made any admission of liability or wrongdoing. On
October 12, 2006, the Superior Court of California approved the settlement of the state and federal
derivative actions and entered final judgment of dismissal. The United States District Court
approved the settlement of the Federal class action in October 2006.
SEC Investigation
The U.S. Securities and Exchange Commission (SEC) issued a formal order of private
investigation dated September 7, 2005, which was furnished to our legal counsel on September 29,
2005, to investigate the circumstances surrounding our restatement of our consolidated financial
statements for the years ended December 31, 2002 and 2003, and for the first three quarters of
2004. The SEC has issued subpoenas for the production of documents and for testimony pursuant to
that investigation to us and others. The SECs investigation is ongoing and we are cooperating
with the investigation.
Other Matters
Our subsidiary, Seragen, Inc. and Ligand, were named parties to Sergio M. Oliver, et al. v.
Boston University, et al., a shareholder class action filed on December 17, 1998 in the Court of
Chancery in the State of Delaware in and for New Castle County, C.A. No. 16570NC, by Sergio M.
Oliver and others against Boston University and others, including Seragen, its subsidiary Seragen
Technology, Inc. and former officers and directors of Seragen. The complaint, as amended, alleged
that we aided and abetted purported breaches of fiduciary duty by the Seragen related defendants in
connection with the acquisition of Seragen by us and made certain misrepresentations in related
proxy materials and seeks compensatory and punitive damages of an unspecified amount. On July 25,
2000, the Delaware Chancery Court granted in part and denied in part defendants motions to
dismiss. Seragen, Ligand, Seragen Technology, Inc. and our acquisition subsidiary, Knight
Acquisition Corporation, were dismissed from the action. Claims of breach of fiduciary duty remain
against the remaining defendants, including the former officers and directors of Seragen. The
court certified a class consisting of shareholders as of the date of the acquisition and on the
date of the proxy sent to ratify an earlier business unit sale by Seragen. On January 20, 2005,
the Delaware Chancery Court granted in part and denied in part the defendants motion for summary
judgment. Prior to trial, several of the Seragen director-defendants reached a settlement with the
plaintiffs. The trial in this action then went forward as to the remaining defendants and
concluded on February 18, 2005. On April 14, 2006, the court issued a memorandum opinion finding
for the plaintiffs and against Boston University and individual directors affiliated with Boston
University on certain claims. The opinion awards damages on these claims in the amount of
approximately $4.8 million plus interest. Judgment, however, has not been entered and the matter
is subject to appeal. While Ligand and our subsidiary Seragen have been dismissed from the action,
such dismissal is also
61
subject to appeal and Ligand and Seragen may have possible indemnification obligations with
respect to certain defendants. As of September 30, 2007, we have not accrued an indemnification
obligation based on our assessment that our responsibility for any such obligation is not probable
or estimable.
We received a letter in March 2007 from counsel to The Salk Institute for Biological Studies,
or Salk, alleging that we owe Salk royalties on prior product sales of Targretin as well as a
percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai inc. (New Jersey) in the
asset sale transaction completed with Eisai in October 2006. Salk alleges that it is owed at least
25% of the consideration paid by Eisai for that portion of our oncology product line and associated
assets attributable to Targretin. In an April 11, 2007 request for mediation, Salk repeated these
claims and asserted additional claims that allegedly increase the amount of royalty buy-out
payments. Representatives from Ligand and Salk attended a mediation hearing in June 2007, which
left the matter unresolved. Salk filed a demand for arbitration in July 2007 with the American
Arbitration Association, seeking at least $22 million for alleged breach of contract based on
Salks theory that it is entitled to a portion of the money paid by Eisai to us for Targretin
related assets. We do not believe that Salk has a valid basis for its claims and intend to
vigorously oppose any claim that Salk may bring for payment related to these matters. The Company
has raised a counterclaim in the arbitration with Salk seeking either a refund of the two $1.1
million lasofoxifene related payments or an offset against any award that may be granted to Salk.
The arbitration with Salk is ongoing.
We received a letter in October 2007 from Rockefeller University, or Rockefeller, claiming
that it is owed 25% of the milestone payments received by us from our partner GlaxoSmithKline for
eltrombopag and the backup compound SB-559448, as well as 25% of any future milestone and royalty
payments that we may receive in the future from GlaxoSmithKline based on development and sale of
these compounds. To date we have received $7 million of milestone payments from GlaxoSmithKline
for these compounds. We have reviewed this claim and do not believe that Rockefeller has a valid
basis for its claim for payment and intends to vigorously oppose any Rockefeller claim for payment
related to these matters. In the letter, Rockefeller also stated its rejection of the Companys
notice sent to Rockefeller on August 9, 2007 to terminate the September 30, 1992 license agreement
between us and Rockefeller.
We
recorded approximately $6.6 million (net) in transaction fees and other costs associated with the
sale of AVINZA to King. We disputed the amount of the fees owed to the investment banking firm and
as a result, the parties agreed to settle the matter for $3.0 million, which was paid in June 2007.
In addition, we are subject to various lawsuits and claims with respect to matters arising out
of the normal course of business. Due to the uncertainty of the ultimate outcome of these matters,
the impact on future financial results is not subject to reasonable estimates.
62
ITEM 1A. RISK FACTORS
The following is a summary description of some of the many risks we face in our business
including any risk factors as to which there may have been a material change from those set forth
in our Annual Report on Form 10-K for the year ended December 31, 2006. You should carefully review
these risks in evaluating our business, including the businesses of our subsidiaries. You should
also consider the other information described in this report.
Risks Related To Us and Our Business.
Failure to timely or successfully restructure our business could have adverse consequences for us.
We completed the sale of our product lines in February 2007. In connection with these sales
we are also restructuring our remaining businesses, principally our research and development
including the consolidation of our staff and facilities. If we are unable to successfully and
timely complete this restructuring, our remaining assets could lose value, we may not be able to
retain key employees, we may not have sufficient resources to successfully manage those assets or
our business, and we may not be able to perform our obligations under various contracts and
commitments. Any of these could have substantial negative impacts on our business and our stock
price.
We are substantially dependent on AVINZA royalties for our revenues.
We recently completed the sale of our two commercial product lines, oncology and pain, which
in recent years provided substantially all of our continuing revenue. In each sale we received a
one-time upfront cash payment. The consideration for the sale of the pain (AVINZA) franchise also
included royalties that we will receive in the future from sales of AVINZA by King Pharmaceuticals,
Inc., who acquired the AVINZA rights from us. These consist of a 15% royalty on AVINZA sales for
the first 20 months, and then royalty payments ranging from 5-15% of AVINZA sales, depending on the
level of total annual sales. These royalties represent and will represent substantially all of our
ongoing revenue for the foreseeable future. Although we may also receive royalties and milestones
from our partners in various past and future collaborations, the amount of revenue from these
royalties and milestones is unknown and highly uncertain.
Thus, any setback that may occur with respect to AVINZA could significantly impair our
operating results and/or reduce the market price for our securities. Setbacks could include
problems with shipping, distribution, manufacturing, product safety, marketing, government licenses
and approvals, intellectual property rights, competition with existing or new products and
physician or patient acceptance of the product, as well as higher than expected total rebates,
returns or discounts. For example, on September 10, 2007, King Pharmaceuticals (King) reported
that Actavis, a manufacturer of generic pharmaceutical products headquartered in Iceland, had filed
with the FDA an Abbreviated New Drug Application, or ANDA, with a Paragraph IV Certification
pertaining to AVINZA, the rights to which were acquired by King Pharmaceuticals from us in February
2007. According to the report, Actaviss Paragraph IV Certification sets forth allegations that
U.S. Patent No. 6,066,339 (the 339 patent) which is listed in the FDAs Approved Drug Products
With Therapeutic Equivalence Evaluations, will not be infringed by Actaviss manufacture, use, or
sale of the product for which the ANDA was submitted. The expiration date for this patent is
November 2017. King Pharmaceuticals Inc., King Pharmaceuticals Research and Development, Inc.,
Elan Corporation, plc and Elan Pharma International Ltd. jointly filed suit in federal district
court in New Jersey on October 18, 2007 against Actavis, Inc. and Actavis Elizabeth LLC for patent
infringement under the 339 patent. The lawsuit seeks a judgment that would, among other things,
prevent Actavis from commercializing their proposed morphine product until after expiration of the
339 patent.
AVINZA was licensed from Elan Corporation which is its sole manufacturer. Any problems with
Elans manufacturing operations or capacity could reduce sales of AVINZA, as could any licensing or
other contract disputes with Elan, raw materials suppliers, or others.
Similarly, Kings AVINZA sales efforts could be affected by a number of factors and decisions
regarding its organization, operations, and activities as well as events both related and unrelated
to AVINZA. Historically, AVINZA sales efforts, including our own and our prior co-promotion
partners, have encountered a number of difficulties, uncertainties and challenges, including sales
force reorganizations and lower than expected sales call
63
and prescription volumes, which have hurt and could continue to hurt AVINZA sales growth.
AVINZA could also face stiffer competition from existing or future pain products. The negative
impact on the products sales growth in turn may cause our royalties, revenues and earnings to be
disappointing.
AVINZA sales also may be susceptible to higher than expected discounts (especially PBM/GPO
rebates and Medicaid rebates, which can be substantial), returns and chargebacks and/or slower than
expected market penetration that could reduce sales. Other setbacks that AVINZA could face in the
sustained-release opioid market include product safety and abuse issues, regulatory action,
intellectual property disputes and the inability to obtain sufficient quotas of morphine from the
Drug Enforcement Agency, or DEA, to support production requirements.
In particular, with respect to regulatory action and product safety issues, the FDA previously
requested expanded warnings on the AVINZA label to alert doctors and patients to the dangers of
using AVINZA with alcohol. Changes were made to the label, however, the FDA also requested
clinical studies to investigate the risks associated with taking AVINZA with alcohol. Any
additional warnings, studies and any further regulatory action could have significant adverse
effects on AVINZA sales.
We rely heavily on collaborative relationships and termination or breach of any of the related
agreements could reduce the financial resources available to us, including milestone payments and
future royalty revenues.
Our strategy for developing and commercializing many of our potential products, including
products aimed at larger markets, includes entering into collaborations with corporate partners,
licensors, licensees and others. These collaborations have provided us with funding and research
and development resources for potential products for the treatment or control of metabolic
diseases, hematopoiesis, womens health disorders, inflammation, cardiovascular disease, cancer and
skin disease, and osteoporosis. These agreements also give our collaborative partners significant
discretion when deciding whether or not to pursue any development program. Our collaborations may
not continue or be successful.
In addition, our collaborators may develop drugs, either alone or with others that compete
with the types of drugs they currently are developing with us. This would result in increased
competition for our programs. If products are approved for marketing under our collaborative
programs, any revenues we receive will depend on the manufacturing, marketing and sales efforts of
our collaborators, who generally retain commercialization rights under the collaborative agreements. Our current collaborators also generally have the right
to terminate their collaborations under specified circumstances. If any of our collaborative
partners breach or terminate their agreements with us or otherwise fail to conduct their
collaborative activities successfully, our product development under these agreements will be
delayed or terminated.
We may have disputes in the future with our collaborators, including disputes concerning which
of us owns the rights to any technology developed before, during or after the research program
under a collaboration. For instance, we were involved in litigation with Pfizer, which we settled
in April 1996, concerning our right to milestones and royalties based on the development and
commercialization of droloxifene. In addition, we received a letter on October 4, 2007 from
Rockefeller University, or Rockefeller, claiming that it is owed 25% of the milestone payments
received by us from our partner GlaxoSmithKline for eltrombopag and the backup compound SB-559448,
as well as 25% of any future milestone and royalty payments that we may receive in the future from
GlaxoSmithKline based on development and sale of these compounds. To date we have received $7
million of milestone payments from GlaxoSmithKline for these compounds. In the letter, Rockefeller
also stated its rejection of our notice sent to Rockefeller on August 9, 2007 to terminate the
September 30, 1992 license agreement between us and Rockefeller. These and other possible
disagreements between us and our collaborators could delay our ability and the ability of our
collaborators to achieve milestones or our receipt of other payments. In addition, any
disagreements could delay, interrupt or terminate the research, development and commercialization
of certain potential products being developed by either our collaborators or by us, or could result
in litigation or arbitration. The occurrence of any of these problems could be time-consuming and
expensive and could adversely affect our business.
Significant returns of products we sold prior to selling our commercial businesses could harm our
operating results.
Under our agreements to sell our commercial businesses, we remain financially responsible for
returns of our products sold before those businesses were transferred to their respective buyers.
Thus if returns of those products are higher than expected, we could incur substantial expenses for
processing and issuing refunds for those returns which, in turn, could hurt our financial results.
The amount of returns could be affected by a number of factors including ongoing product demand,
product rotation at distributors and wholesalers, and product stability issues.
Return from any dividend is speculative; you may not receive a return on your securities.
In general, we intend to retain any earnings to support the expansion of our business. We
have paid a special dividend of a substantial portion of the net proceeds from our product line
asset sales. However, other than this special dividend, we do not anticipate paying cash dividends
on any of our securities in the foreseeable future. Any returns you receive from our stock will be
highly dependent on increases in the market price for our securities, if any. The price for our
common stock has been highly volatile and may decrease.
We will have continuing obligations to indemnify the buyers of our commercial businesses, and may
be subject to other liabilities related to the sale of our commercial product lines.
In connection with the sale of our AVINZA product line, we have agreed to indemnify King for a
period of 16 months after the closing for a number of specified matters including the breach of our
representations, warranties and covenants contained in the asset purchase agreement, and in some
cases for a period of 30 months following the closing of the asset sale. In addition, we have
agreed to indemnify Eisai, the purchaser of our oncology product line, after the closing of the
asset sale, for damages suffered by Eisai arising for any breach of any of the representations,
warranties, covenants or obligations we have made in the asset purchase agreement. Our obligation
to indemnify Eisai survives the closing in some cases up to 18 or 36 months following the closing,
and in other cases, until the expiration of the applicable statute of limitations. In a few
instances, our obligation to indemnify Eisai survives in perpetuity. Under our agreement with
King, $15.0 million of the total upfront cash payment was deposited into an escrow account to
secure our indemnification obligations to King following the closing. As of September 30, 2007,
$7.5 million remained in the King escrow account. Similarly, our agreement with Eisai required
that $20.0 million of the total upfront cash payment be deposited into an escrow account to secure
our indemnification obligations to Eisai after the closing. As of September 30, 2007, $10.0
million remained in the Eisai escrow account.
Our indemnification obligations under the asset purchase agreements could cause us to be
liable to King or Eisai under certain circumstances, in excess of the amounts set forth in the
escrow accounts. The AVINZA asset purchase agreement also allows King, under certain
circumstances, to set off indemnification claims against the royalty payments payable to us. Under
the asset purchase agreements, our liability for any indemnification claim
64
brought by King and Eisai is generally limited to $40.0 million and $30.0 million,
respectively. However, our obligation to provide indemnification on certain matters is not subject
to these indemnification limits. For example, we agreed to retain, and provide indemnification
without limitation to King, for all liabilities arising under certain agreements with Catalent
Pharma Solutions related to the manufacture of AVINZA. Similarly, we agreed to retain, and provide
indemnification without limitation to Eisai, for all liabilities related to certain claims
regarding promotional materials for the ONTAK and Targretin drug products. We cannot predict the
liabilities that may arise as a result of these matters. Any liability claims related to these
matters or any indemnification claims made by King or Eisai could materially and adversely affect
our financial condition.
We may also be subject to other liabilities related to the products we recently sold. For
example, we received a letter in March 2007 from counsel to the Salk Institute for Biological
Studies alleging that we owe The Salk Institute royalties on prior sales of Targretin as well as a
percentage of the amounts received from Eisai. Salk alleges that it is owed at least 25% of the
consideration paid by Eisai for that portion of our oncology product line and associated assets
attributable to Targretin. In an April 11, 2007 request for mediation, Salk repeated these claims
and asserted additional claims that allegedly increase the amount of royalty buy-out payments.
Representatives from Ligand and Salk attended a mediation hearing in June 2007, which left the
matter unresolved. Salk filed a demand for arbitration in July 2007 with the American Arbitration
Association, seeking at least $22 million for alleged breach of contract based on Salks theory
that it is entitled to a portion of the money paid by Eisai to Ligand for Targretin related assets.
We do not believe that Salk has a valid basis for its claims and intend to vigorously oppose any
claim that Salk may bring for payment related to these matters. Also, as previously disclosed, in connection with the AVINZA sale
transaction, King assumed our obligation to make payments to Organon based on net sales of AVINZA
(the fair value of which approximated $93.2 million as of February 26, 2007). As Organon did not
consent to the legal assignment of the co-promote termination obligation from us to King, we remain
liable to Organon in the event of Kings default of this obligation. Any successful claim brought
against us by Salk or others or any requirement to pay a material amount to Organon in the event of
Kings default on its assumed obligation to Organon could cause our stock price to fall and could
decrease our cash or otherwise adversely affect our business.
Our product development involves a number of uncertainties, and we may never generate sufficient
revenues from the sale of products to become profitable.
We were founded in 1987. We have incurred significant losses since our inception. At
September 30, 2007, our accumulated deficit was approximately $587.5 million. We began generating
commercial product revenues in 1999; however, we completed the sale of all of our commercial
products in February 2007 and are now focused on our product development pipeline.
Most of our products in development will require extensive additional development, including
preclinical testing and human studies, as well as regulatory approvals, before we can market them.
We cannot predict if or when any of the products we are developing or those being developed with
our partners will be approved for marketing. For example, lasofoxifene (Oporia), a partner product
being developed by Pfizer received a non-approvable decision from the FDA. There are many
reasons why we or our collaborative partners may fail in our efforts to develop our other potential
products, including the possibility that:
|
Ø |
|
preclinical testing or human studies may show that our potential products are ineffective or cause
harmful side effects; |
|
|
Ø |
|
the products may fail to receive necessary regulatory approvals from the FDA or foreign
authorities in a timely manner, or at all; |
|
|
Ø |
|
the products, if approved, may not be produced in commercial quantities or at reasonable costs; |
65
|
Ø |
|
the products, if approved, may not achieve commercial acceptance; |
|
|
Ø |
|
regulatory or governmental authorities may apply restrictions to our products, which could
adversely affect their commercial success; or |
|
|
Ø |
|
the proprietary rights of other parties may prevent us or our partners from marketing the products. |
|
|
|
|
|
Any product development failures for these or other reasons, whether with our products or our
partners products, may reduce our expected revenues, profits, and stock price.
Our drug development programs will require substantial additional future funding which could hurt
our operational and financial condition.
Our drug development programs require substantial additional capital to successfully complete
them, arising from costs to:
|
Ø |
|
conduct research, preclinical testing and human studies; |
|
|
Ø |
|
establish pilot scale and commercial scale manufacturing processes and facilities; and |
|
|
Ø |
|
establish and develop quality control, regulatory, marketing, sales and
administrative capabilities to support these programs. |
|
Our future operating and capital needs will depend on many factors, including:
|
Ø |
|
the pace of scientific progress in our research and development programs and the magnitude of these
programs; |
|
|
Ø |
|
the scope and results of preclinical testing and human studies; |
|
|
Ø |
|
the time and costs involved in obtaining regulatory approvals; |
|
|
Ø |
|
the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
|
|
Ø |
|
competing technological and market developments; |
|
|
Ø |
|
our ability to establish additional collaborations; |
|
|
Ø |
|
changes in our existing collaborations; |
|
|
Ø |
|
the cost of manufacturing scale-up; and |
|
|
Ø |
|
the effectiveness of our commercialization activities. |
|
|
|
|
|
We expect our research and development expenditures over the next three years to continue to
be significant. However, we base our outlook regarding the need for funds on many uncertain
variables. Such uncertainties include regulatory approvals, the timing of events outside our
direct control such as product launches by partners and the success of such product launches,
negotiations with potential strategic partners, possible sale of assets or other transactions and
other factors. Any of these uncertain events can significantly change our cash requirements.
While we expect to fund our research and development activities primarily from cash generated
from AVINZA royalties to the extent possible, if we are unable to do so we may need to complete
additional equity or debt
66
financings or seek other external means of financing. These financings could depress our
stock price. If additional funds are required to support our operations and we are unable to
obtain them on terms favorable to us, we may be required to cease or reduce further development or
commercialization of our products, to sell some or all of our technology or assets or to merge with
another entity.
Our product candidates face significant regulatory hurdles prior to marketing which could delay or
prevent sales.
Before we obtain the approvals necessary to sell any of our potential products, we must show
through preclinical studies and human testing that each product is safe and effective. We and our
partners have a number of products moving toward or currently in clinical trials, including
lasofoxifene for which Pfizer announced receipt of non-approval letters from the FDA, and two
products in Phase III trials by one of our partners involving bazedoxifene. Failure to show any
products safety and effectiveness would delay or prevent regulatory approval of the product and
could adversely affect our business. The clinical trials process is complex and uncertain. The
results of preclinical studies and initial clinical trials may not necessarily predict the results
from later large-scale clinical trials. In addition, clinical trials may not demonstrate a
products safety and effectiveness to the satisfaction of the regulatory authorities. A number of
companies have suffered significant setbacks in advanced clinical trials or in seeking regulatory
approvals, despite promising results in earlier trials. The FDA may also require additional
clinical trials after regulatory approvals are received, which could be expensive and
time-consuming, and failure to successfully conduct those trials could jeopardize continued
commercialization.
The rate at which we complete our clinical trials depends on many factors, including our
ability to obtain adequate supplies of the products to be tested and patient enrollment. Patient
enrollment is a function of many factors, including the size of the patient population, the
proximity of patients to clinical sites and the eligibility criteria for the trial. Delays in
patient enrollment for our trials may result in increased costs and longer development times. In
addition, our collaborative partners have rights to control product development and clinical
programs for products developed under the collaborations. As a result, these collaborators may
conduct these programs more slowly or in a different manner than we had expected. Even if clinical
trials are completed, we or our collaborative partners still may not apply for FDA approval in a
timely manner or the FDA still may not grant approval.
The restatement of our consolidated financial statements has had a material adverse impact on us,
including increased costs and the increased possibility of legal or administrative proceedings.
We determined that our consolidated financial statements for the years ended December 31, 2002
and 2003, and for the first three quarters of 2004, as described in more detail in our 2004 Annual
Report on Form 10-K, should be restated. As a result of these events, we have become subject to a
number of additional risks and uncertainties, including:
|
|
We incurred substantial unanticipated costs for accounting and legal
fees in 2005 in connection with the restatement. Although the
restatement is complete, we expect to continue to incur unanticipated
accounting and legal costs as noted below. |
|
|
|
The SEC has instituted a formal investigation of our restated
consolidated financial statements identified above. This investigation
will likely divert more of our managements time and attention and
cause us to incur substantial costs. Such investigations can also
lead to fines or injunctions or orders with respect to future
activities, as well as further substantial costs and diversion of
management time and attention. |
Material weaknesses or deficiencies in our internal control over financial reporting could harm
stockholder and business confidence on our financial reporting, our ability to obtain financing and
other aspects of our business.
As disclosed in our 2005 Annual Report on Form 10-K, managements assessment of our internal
control over financial reporting identified material weaknesses in our internal controls
surrounding (i) the accounting for revenue recognition; (ii) record keeping and documentation;
(iii) accounting personnel; (iv) financial statement close procedures; (v) our inability to
maintain an effective independent Internal Audit Department; (vi) the existence of ineffective
spreadsheet controls used in connection with our financial processes, including review, testing,
access
67
and integrity controls; (vii) the existence of accounting system access rights granted to
certain members of our accounting and finance department that are incompatible with the current
roles and duties of such individuals (i.e., segregation of duties); and (viii) the inability of
management to properly maintain our documentation of the internal control over financial reporting
during 2005 or to substantively commence the process to update such documentation and assessment
until December 2005. As of December 31, 2006, these material weaknesses were fully remediated.
While no material weaknesses were identified as of December 31, 2006, we cannot assure you
that material weaknesses will not be identified in future periods. The existence of one or more
material weakness or significant deficiency could result in errors in our consolidated financial
statements, and substantial costs and resources may be required to rectify any internal control
deficiencies. If we fail to achieve and maintain the adequacy of our internal controls in
accordance with applicable standards, we may be unable to conclude on an ongoing basis that we have
effective internal controls over financial reporting. If we cannot produce reliable financial
reports, our business and financial condition could be harmed, investors could lose confidence in
our reported financial information, or the market price of our stock could decline significantly.
In addition, our ability to obtain additional financing to operate and expand our business, or
obtain additional financing on favorable terms, could be materially and adversely affected, which,
in turn, could materially and adversely affect our business, our financial condition and the market
value of our securities. Also, perceptions of us could also be adversely affected among customers,
lenders, investors, securities analysts and others. Any future weaknesses or deficiencies could
also hurt our ability to do business with these groups.
We may require additional money to run our business and may be required to raise this money on
terms which are not favorable or which reduce our stock price.
We have incurred losses since our inception and may not generate positive cash flow to fund
our operations for one or more years. As a result, we may need to complete additional equity or
debt financings to fund our operations. Our inability to obtain additional financing could
adversely affect our business. Financings may not be available at all or on favorable terms. In
addition, these financings, if completed, still may not meet our capital needs and could result in
substantial dilution to our stockholders. For instance, in April 2002 and September 2003 we issued
an aggregate of 7.7 million shares of our common stock in private placement offerings. In
addition, in November 2002 we issued in a private placement $155.3 million in aggregate principal
amount of our 6% convertible subordinated notes due 2007 that converted into approximately 25.1
million shares of our common stock. The conversion of all of the notes was completed in November
2006.
If adequate funds are not available, we may be required to delay, reduce the scope of or
eliminate one or more of our research or drug development programs, or our marketing and sales
initiatives. We may also be required to liquidate our business or file for bankruptcy protection.
Alternatively, we may be forced to attempt to continue development by entering into arrangements
with collaborative partners or others that require us to relinquish some or all of our rights to
technologies or drug candidates that we would not otherwise relinquish.
68
Challenges to or failure to secure patents and other proprietary rights may significantly hurt our
business.
Our success will depend on our ability and the ability of our licensors to obtain and maintain
patents and proprietary rights for our potential products both in the United States and in foreign
countries. Patents may not be issued from any of these applications currently on file, or, if
issued, may not provide sufficient protection.
Our patent position, like that of many biotech and pharmaceutical companies, is uncertain and
involves complex legal and technical questions for which important legal principles are unresolved.
We may not develop or obtain rights to products or processes that are patentable. Even if we do
obtain patents, they may not adequately protect the technology we own or have licensed. In
addition, others may challenge, seek to invalidate, infringe or circumvent any patents we own or
license, and rights we receive under those patents may not provide competitive advantages to us.
Any conflicts resulting from the patent rights of others could significantly reduce the
coverage of our patents and limit our ability to obtain meaningful patent protection.
We have had and will continue to have discussions with our current and potential collaborators
regarding the scope and validity of our patents and other proprietary rights. If a collaborator or
other party successfully establishes that our patent rights are invalid, we may not be able to
continue our existing collaborations beyond their expiration. Any determination that our patent
rights are invalid also could encourage our collaborators to terminate their agreements where
contractually permitted. Such a determination could also adversely affect our ability to enter
into new collaborations.
We may also need to initiate litigation, which could be time-consuming and expensive, to
enforce our proprietary rights or to determine the scope and validity of others rights. If
litigation results, a court may find our patents or those of our licensors invalid or may find that
we have infringed on a competitors rights. If any of our competitors have filed patent
applications in the United States which claim technology we also have invented, the Patent and
Trademark Office may require us to participate in expensive interference proceedings to determine
who has the right to a patent for the technology.
We also rely on unpatented trade secrets and know-how to protect and maintain our competitive
position. We require our employees, consultants, collaborators and others to sign confidentiality
agreements when they begin
69
their relationship with us. These agreements may be breached, and we may not have adequate
remedies for any breach. In addition, our competitors may independently discover our trade
secrets.
Third party intellectual property may prevent us or our partners from developing our potential
products and we may owe a portion of any payments we receive from our collaboration partners to one
or more third parties.
Our success will depend on our ability and the ability of our partners to avoid infringing the
proprietary rights of others, both in the United States and in foreign countries. In addition,
disputes with licensors under our license agreements may arise which could result in additional
financial liability or loss of important technology and potential products and related revenue, if
any. Further, the manufacture, use or sale of our potential products or our partners products or
potential products may infringe the patent rights of others. This could impact AVINZA,
eltrombopag, Bazedoxifene, lasofoxifene, LGD-4665 and any other products or potential products of
ours or our partners. See Note 4 of the consolidated financial statements, Collaboration
Agreements and Royalty Matters.
Several drug companies and research and academic institutions have developed technologies,
filed patent applications or received patents for technologies that may be related to our business.
Others have filed patent applications and received patents that conflict with patents or patent
applications we have licensed for our use, either by claiming the same methods or compounds or by
claiming methods or compounds that could dominate those licensed to us. In addition, we may not be
aware of all patents or patent applications that may impact our ability to make, use or sell any of
our potential products. For example, US patent applications may be kept confidential while pending
in the Patent and Trademark Office and patent applications filed in foreign countries are often
first published six months or more after filing.
While we periodically receive communications or have conversations with the owners of other
patents or other intellectual property, none of these third parties have directly threatened an
action or claim against us other than the Salk and Rockefeller claims described herein. If others
obtain patents with conflicting claims, we may be required to obtain licenses to those patents or
to develop or obtain alternative technology. We may not be able to obtain any such licenses on
acceptable terms, or at all. Any failure to obtain such licenses could delay or prevent us from
pursuing the development or commercialization of our potential products.
Our legacy commercial businesses expose us to product liability risks and we may not have
sufficient insurance to cover any claims.
We completed the sale of our commercial businesses in February 2007. Nevertheless, products
we sold prior to divesting these businesses expose us to potential product liability risks. For
example, such products may need to be recalled to address regulatory issues. A successful product
liability claim or series of claims brought against us could result in payment of significant
amounts of money and divert managements attention from running our business.
In addition, some of the compounds we are investigating may be harmful to humans. For example,
retinoids as a class are known to contain compounds which can cause birth defects. We may not be
able to maintain our insurance on acceptable terms, or our insurance may not provide adequate
protection in the case of a product liability claim. To the extent that product liability
insurance, if available, does not cover potential claims, we will be required to self-insure the
risks associated with such claims. We believe that we carry reasonably adequate insurance for
product liability claims.
We use hazardous materials which requires us to incur substantial costs to comply with
environmental regulations.
In connection with our research and development activities, we handle hazardous materials,
chemicals and various radioactive compounds. To properly dispose of these hazardous materials in
compliance with environmental regulations, we are required to contract with third parties at
substantial cost to us. Our annual cost of compliance with these regulations is approximately $0.7
million. We cannot completely eliminate the risk of accidental contamination or injury from the
handling and disposing of hazardous materials, whether by us or by our
third-party contractors. In the event of any accident, we could be held liable for any
damages that result, which could be significant. We believe that we carry reasonably adequate
insurance for toxic tort claims.
70
Our stock price has been volatile and could experience a sudden decline in value.
Our common stock has experienced significant price and volume fluctuations and may continue to
experience volatility in the future. You may not be able to sell your shares quickly or at the
latest market price if trading in our stock is not active or the volume is low. The following
factors, in addition to other risk factors described in this section, may have a significant impact
on the market price of our common stock:
|
|
|
results of or delays in our preclinical studies and clinical trials; |
|
|
|
|
the success of our collaboration agreements; |
|
|
|
|
publicity regarding actual or potential medical results relating to products under
development
by us or others; |
|
|
|
|
announcements of technological innovations or new commercial products by us or
others; |
|
|
|
|
developments in patent or other proprietary rights by us or others; |
|
|
|
|
comments or opinions by securities analysts or major stockholders; |
|
|
|
|
future sales of our common stock by existing stockholders; |
|
|
|
|
regulatory developments or changes in regulatory guidance; |
|
|
|
|
litigation or threats of litigation; |
|
|
|
|
economic and other external factors or other disaster or crises; |
|
|
|
|
the departure of any of our officers, directors or key employees; |
|
|
|
|
period-to-period fluctuations in financial results; and |
|
|
|
|
limited daily trading volume. |
The National Association of Securities Dealers, Inc., or NASD, and the Securities and Exchange
Commission, or SEC, have adopted certain new rules. If we were unable to continue to comply with
the new rules, we could be delisted from trading on the NASDAQ Global Market, or Nasdaq, and
thereafter trading in our common stock, if any, would be conducted through the over-the-counter
market or on the Electronic Bulletin Board of the NASD. As a consequence of such delisting, an
investor would likely find it more difficult to dispose of, or to obtain quotations as to the price
of, our common stock. Delisting of our common stock could also result in lower prices per share of
our common stock than would otherwise prevail.
In March 2007, we announced that our Board of Directors authorized a stock repurchase program
under Rule 10b-18 of the Securities Exchange Act of 1934, as amended, of up to $100 million of
shares of our common stock in the open market and negotiated purchases over a period of 12 months.
For the nine months ended September 30, 2007, we had repurchased 5.4 million shares of our common
stock in open market transactions at varying prices for an aggregate purchase price of
approximately $35.5 million, which leaves approximately $64.5 million available for potential
future repurchases of common stock as of September 30, 2006. During October 2007, we repurchased
an additional 0.4 million shares of our common stock totaling $2.2 million. The existence of such
a program may contribute to the volatility and liquidity of the price of our common stock and could
contribute to a sudden decline in value.
Our shareholder rights plan and charter documents may hinder or prevent change of control
transactions.
Our shareholder rights plan and provisions contained in our certificate of incorporation and
bylaws may discourage transactions involving an actual or potential change in our ownership. In
addition, our Board of Directors may issue shares of preferred stock without any further action by
you. Such issuances may have the effect of delaying or preventing a change in our ownership. If
changes in our ownership are discouraged, delayed or prevented, it would be more difficult for our
current Board of Directors to be removed and replaced, even if you or our other stockholders
believe that such actions are in the best interests of us and our stockholders.
We
may lose some or all of the value of some of our short term
investments.
We
engage one or more third parties to manage some of our cash
consistent with an investment policy that allows a range of
investments and maturities. The investments are intended to maintain
safety of principal while providing liquidity adequate to meet
projected cash requirements. A secondary objective is to achieve a
yield on the portfolio which is commensurate with the risk levels
contemplated by the primary objective. Risks of principal loss is to
be minimized through diversified short and medium term investments of
high quality, but the investments are not in every case guaranteed
or fully insured. In light of the recent changes in the credit
market, one of our short term investments in commercial paper is now
in default. We intend to pursue collection efforts, but we might not
recoup some or all of our investment in the commercial paper. In
addition, from time to time we may suffer other losses on our short
term investment portfolio.
71
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuer Purchases of Equity Securities(1) |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Maximum Dollar |
|
|
|
Total Number of |
|
|
Average |
|
|
Number of Shares |
|
|
Value |
|
|
|
Shares |
|
|
Price Paid |
|
|
Purchased as Part |
|
|
of Shares That May |
|
|
|
Purchased |
|
|
Per |
|
|
of Publicly |
|
|
Yet Be Purchased |
|
Month |
|
During Month (2) |
|
|
Share (3) |
|
|
Announced Plan |
|
|
Under the Plan (4) |
|
July 1 to July 31, 2007 |
|
|
|
|
|
$ |
|
|
|
|
3,777,523 |
|
|
$ |
74,605,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
August 1 to August 31, 2007 |
|
|
1,604,268 |
|
|
$ |
6.20 |
|
|
|
5,381,791 |
|
|
$ |
64,605,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 1 to September
30, 2007 |
|
|
25,000 |
|
|
$ |
5.59 |
|
|
|
5,406,791 |
|
|
$ |
64,465,130 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
1,629,268 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
In March 2007, we announced that our board of directors authorized a stock
repurchase program under Rule 10b-18 of the Securities Exchange Act of 1934, as
amended, of up to $100 million of shares of our common stock in the open market
and negotiated purchases over a period of 12 months. The above table provides
information regarding our stock repurchases in the quarter ended September 30,
2007. This program expires in March 2008 and may be discontinued at any time. |
|
(2) |
|
The purchases were made in open-market transactions. |
|
(3) |
|
Excludes commissions paid, if any, related to the share repurchase transactions. |
|
(4) |
|
Represents the difference between the $100,000,000 of share repurchases
authorized by our board of directors and the value of the shares repurchased
from March 2007 through the indicated month. |
72
ITEM 6. EXHIBITS
|
|
|
Exhibit Number |
|
Description |
3.1 (1)
|
|
Amended and Restated Certificate of Incorporation of the Company (Filed as
Exhibit 3.2). |
|
|
|
3.2 (1)
|
|
Bylaws of the Company, as amended (Filed as Exhibit 3.3). |
|
|
|
3.3 (2)
|
|
Amended Certificate of Designation of Rights, Preferences and Privileges of
Series A Participating Preferred Stock of the Company. |
|
|
|
3.4 (3)
|
|
Certificate of Amendment of the Amended and Restated Certificate of
Incorporation of the Company dated June 14, 2000. |
|
|
|
3.5 (4)
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Certificate of Amendment of the Amended and Restated Certificate of
Incorporation of the Company dated September 30, 2004. |
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3.6 (5)
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Amendment to the Bylaws dated November 13, 2005 (Filed as Exhibit 3.1). |
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4.1 (6)
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Specimen stock certificate for shares of Common Stock of the Company. |
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4.2 (7)
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Indenture dated November 26, 2002, between Ligand Pharmaceuticals Incorporated
and J.P. Morgan Trust Company, National Association, as trustee, with respect
to the 6% convertible subordinated notes due 2007 (Filed as Exhibit 4.3). |
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4.3 (7)
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Form of 6% Convertible Subordinated Note due 2007 (Filed as Exhibit 4.4). |
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4.4 (7)
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Pledge Agreement dated November 26, 2002, between Ligand Pharmaceuticals
Incorporated and J.P. Morgan Trust Company, National Association (Filed as
Exhibit 4.5). |
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4.5 (7)
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Control Agreement dated November 26, 2002, among Ligand Pharmaceuticals
Incorporated, J.P. Morgan Trust Company, National Association and JP Morgan
Chase Bank (Filed as Exhibit 4.6). |
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4.6 (8)
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2006 Preferred Shares Rights Agreement, by and between Ligand Pharmaceuticals
Incorporated and Mellon Investor Services LLC, dated as of October 13, 2006
(Filed as Exhibit 4.1). |
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10.315 (9)
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Form of Executive Officer Change in
Control Severance Agreement (Filed
as Exhibit 10.1). |
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31.1
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Certification of Principal Executive
Officer, Pursuant to Rules 13a-14(a)
and 15d-14(a), as adopted pursuant
to Section 302 of the Sarbanes-Oxley
Act of 2002. |
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31.2
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Certification of Principal Financial
Officer, Pursuant to Rules 13a-14(a)
and 15d-14(a), as adopted pursuant
to Section 302 of the Sarbanes-Oxley
Act of 2002. |
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32.1
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Certification of Principal Executive
Officer, Pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002. |
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32.2
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Certification of Principal Financial
Officer, Pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley
Act of 2002. |
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(1) |
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This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Registration Statement on Form S-4 (No. 333-58823)
filed on July 9, 1998. |
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(2) |
|
This exhibit was previously filed as part of and is hereby incorporated by reference to same
numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period ended
March 31, 1999. |
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(3) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 2000. |
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(4) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2004. |
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(5) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
number and exhibit filed with the Companys Current Report on Form 8-K filed on November 14,
2005. |
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(6) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Registration Statement on Form S-1 (No.
33-47257) filed on April 16, 1992 as amended. |
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(7) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Registration Statement on Form S-3 (No. 333-102483)
filed on January 13, 2003, as amended. |
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(8) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on October 17,
2006. |
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(9) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on August 22, 2007. |
73
LIGAND PHARMACEUTICALS INCORPORATED
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: November 8, 2007 |
By: |
/S/ John P. Sharp
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John P. Sharp |
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Vice President, Finance and Chief Financial Officer |
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74