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 March 31, 2006 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
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77-0160744 |
(State or Other Jurisdiction of
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(I.R.S. Employer |
Incorporation or Organization)
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Identification No.) |
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10275 Science Center Drive
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92121-1117 |
San Diego, CA
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(Zip Code) |
(Address of Principal Executive Offices) |
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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. 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 April 30, 2006, the registrant had 78,509,410 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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March 31, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
49,808 |
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$ |
66,756 |
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Short-term investments |
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17,897 |
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20,174 |
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Accounts receivable, net |
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20,046 |
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20,954 |
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Current portion of inventories, net |
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8,232 |
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9,333 |
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Other current assets |
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16,357 |
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15,750 |
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Total current assets |
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112,340 |
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132,967 |
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Restricted investments |
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1,826 |
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1,826 |
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Long-term portion of inventories, net |
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5,486 |
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5,869 |
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Property and equipment, net |
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21,758 |
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22,483 |
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Acquired technology, product rights and royalty buy-down, net |
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143,268 |
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146,770 |
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Other assets |
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4,011 |
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4,704 |
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Total assets |
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$ |
288,689 |
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$ |
314,619 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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Current liabilities: |
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Accounts payable |
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$ |
16,325 |
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$ |
15,360 |
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Accrued liabilities |
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43,502 |
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59,587 |
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Current portion of deferred revenue, net |
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151,021 |
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157,519 |
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Current portion of co-promote termination liability |
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42,533 |
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Current portion of equipment financing obligations |
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2,298 |
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2,401 |
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Current portion of long-term debt |
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350 |
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344 |
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Total current liabilities |
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256,029 |
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235,211 |
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Long-term debt |
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140,553 |
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166,745 |
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Long-term portion of co-promote termination liability |
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93,708 |
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Long-term portion of equipment financing obligations |
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3,251 |
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3,430 |
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Long-term portion of deferred revenue, net |
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4,124 |
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4,202 |
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Other long-term liabilities |
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3,037 |
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3,105 |
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Total liabilities |
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500,702 |
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412,693 |
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Commitments and contingencies |
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Common stock subject to conditional redemption; 997,568
shares issued and outstanding at March 31, 2006 and December
31, 2005 |
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12,345 |
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12,345 |
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Stockholders deficit: |
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Convertible preferred stock, $0.001 par value; 5,000,000
shares authorized; none issued |
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Common stock, $0.001 par value; 200,000,000 shares
authorized; 77,496,166 and 73,136,340 shares issued at March
31, 2006 and
December 31, 2005, respectively |
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78 |
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73 |
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Additional paid-in capital |
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748,742 |
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720,988 |
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Accumulated other comprehensive income |
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1,021 |
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490 |
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Accumulated deficit |
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(973,288 |
) |
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(831,059 |
) |
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(223,447 |
) |
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(109,508 |
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Treasury stock, at cost; 73,842 shares |
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(911 |
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(911 |
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Total stockholders deficit |
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(224,358 |
) |
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(110,419 |
) |
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$ |
288,689 |
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$ |
314,619 |
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See accompanying notes.
3
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share data)
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Three Months Ended March 31, |
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2006 |
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2005 |
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Revenues: |
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Product sales |
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$ |
47,984 |
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$ |
35,045 |
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Collaborative research and development and other revenues |
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2,972 |
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1,940 |
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Total revenues |
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50,956 |
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36,985 |
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Operating costs and expenses: |
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Cost of products sold |
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9,740 |
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11,065 |
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Research and development |
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12,218 |
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14,735 |
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Selling, general and administrative |
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22,201 |
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19,215 |
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Co-promotion |
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10,957 |
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7,740 |
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Co-promote termination charges |
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132,941 |
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Total operating costs and expenses |
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188,057 |
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52,755 |
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Loss from operations |
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(137,101 |
) |
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(15,770 |
) |
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Other income (expense): |
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Interest income |
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573 |
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444 |
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Interest expense |
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(6,067 |
) |
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(3,127 |
) |
Other, net |
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383 |
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1 |
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Total other expense, net |
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(5,111 |
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(2,682 |
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Loss before income taxes |
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(142,212 |
) |
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(18,452 |
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Income tax expense |
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(17 |
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(20 |
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Net loss |
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$ |
(142,229 |
) |
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$ |
(18,472 |
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Basic and diluted per share amounts: |
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Net loss |
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$ |
(1.84 |
) |
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$ |
(0.25 |
) |
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Weighted average number of common shares |
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77,496,969 |
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73,916,470 |
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See accompanying notes.
4
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
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Three Months Ended March 31, |
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2006 |
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2005 |
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Operating activities |
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Net loss |
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$ |
(142,229 |
) |
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$ |
(18,472 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Amortization of acquired technology and license rights |
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3,570 |
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3,236 |
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Depreciation and amortization of property and equipment |
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913 |
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969 |
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Amortization of debt issue costs |
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244 |
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254 |
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Gain on sale of Exelixis stock |
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(343 |
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Stock-based compensation |
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814 |
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Non-cash interest expense converted into additional paid-in capital |
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57 |
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Other |
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(8 |
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28 |
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Changes in operating assets and liabilities: |
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Accounts receivable, net |
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908 |
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12,523 |
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Inventories, net |
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1,484 |
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(1,144 |
) |
Other current assets |
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(144 |
) |
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637 |
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Accounts payable and accrued liabilities |
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(14,912 |
) |
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(958 |
) |
Other liabilities |
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(3 |
) |
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(2 |
) |
Deferred revenue, net |
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(6,576 |
) |
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332 |
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Co-promote termination liability |
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136,241 |
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Net cash used in operating activities |
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(19,984 |
) |
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(2,597 |
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Investing activities |
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Purchases of short-term investments |
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(4,726 |
) |
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(21,425 |
) |
Proceeds from sale of short-term investments |
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7,884 |
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2,945 |
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Purchases of property and equipment |
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(190 |
) |
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(597 |
) |
Payment to buy-down ONTAK royalty obligation |
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(20,000 |
) |
Capitalized portion of payment of lasofoxifene royalty rights |
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(558 |
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Other, net |
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27 |
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60 |
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Net cash provided by (used in) investing activities |
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2,995 |
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(39,575 |
) |
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Financing activities |
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Principal payments on equipment financing obligations |
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(680 |
) |
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(723 |
) |
Proceeds from equipment financing arrangements |
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398 |
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|
880 |
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Repayment of long-term debt |
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(86 |
) |
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(82 |
) |
Proceeds from issuance of common stock |
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468 |
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|
773 |
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Decrease in other long-term liabilities |
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(59 |
) |
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(30 |
) |
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Net cash provided by financing activities |
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41 |
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818 |
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Net decrease in cash and cash equivalents |
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(16,948 |
) |
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(41,354 |
) |
Cash and cash equivalents at beginning of period |
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66,756 |
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92,310 |
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Cash and cash equivalents at end of period |
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$ |
49,808 |
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$ |
50,956 |
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Supplemental disclosure of cash flow information |
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Interest paid |
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$ |
517 |
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$ |
328 |
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Non-cash impact of the conversion of 6% convertible subordinated notes
into common stock: |
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Conversion of principal amount of convertible notes |
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$ |
26,100 |
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$ |
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Conversion of unamortized debt issue costs |
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(351 |
) |
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Conversion of unpaid accrued interest |
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264 |
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$ |
26,013 |
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$ |
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Non-cash impact of stock option exercises where cash was received
subsequent to quarter-end |
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$ |
469 |
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$ |
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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 Form 10-Q 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-month periods ended March 31, 2006 and 2005 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,
2005.
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.
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.
Loss Per Share. Net loss per share is computed using the weighted average number of common shares
outstanding. Basic and diluted net 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. Potential common shares, the shares that would be issued upon
the conversion of convertible notes and the exercise of outstanding warrants and stock options were
28.9 million and 32.7 million at March 31, 2006 and December 31, 2005, respectively.
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. However, 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 the
estimated fair value of these indemnification agreements is minimal and has no liabilities recorded
for these agreements as of March 31, 2006 and December 31, 2005.
6
The Company enters into indemnification provisions under its agreements with other companies
in its ordinary course of business, typically with business partners, 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 March 31, 2006 and December 31,
2005.
Accounting for Stock-Based Compensation. Prior to January 1, 2006, the Company accounted for
stock-based compensation in accordance with Accounting Principles Board (APB) Opinion No. 25,
Accounting for Stock Issued to Employees, and related interpretations. The pro forma effects of
employee stock options were disclosed as required by Financial Accounting Standard Board Statement
No. 123, Accounting for Stock-Based Compensation (SFAS 123).
Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards
(SFAS) 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 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 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 in the first quarter 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 (EITF) 96-18, Accounting for Equity Instruments That
Are Issued to Other Than Employees for Acquiring, or in Conjunction With Selling, Goods or
Services.
Total compensation expense for stock-based compensation for the three months ended March 31,
2006 was approximately $0.8 million. There was no deferred tax benefit recognized in connection
with this cost.
Results for the quarter ended March 31, 2005 have not been retrospectively adjusted. The fair
value of the options was estimated using a Black-Scholes option-pricing formula and amortized to
expense over the options vesting periods.
7
The following table illustrates the pro forma effect of share-based compensation on net loss
and loss per share for the quarter ended March 31, 2005 (in thousands, except per share data):
|
|
|
|
|
|
|
Three Months |
|
|
|
Ended March 31, |
|
|
|
2005 |
|
Net loss, as reported |
|
$ |
(18,472 |
) |
|
|
|
|
|
Stock-based employee compensation expense included in
reported net loss |
|
|
|
|
|
|
|
|
|
Less: total stock-based compensation expense determined
under fair value based method for all awards continuing to
vest |
|
|
(757 |
) |
|
|
|
|
|
Less: total stock-based compensation expense determined
under fair value based method for options accelerated in
January 2005 (1) |
|
|
(12,455 |
) |
|
|
|
|
|
Net loss, pro forma |
|
$ |
(31,684 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
Net loss per share as reported |
|
$ |
(0.25 |
) |
|
|
|
|
Net loss per share pro forma |
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
(1) |
|
Represents pro forma unrecognized expense for accelerated options as of the date of
acceleration. |
On January 31, 2005, Ligand accelerated the vesting of certain unvested and out-of-the-money
stock options previously awarded to the executive officers and other employees under the Companys
1992 and 2002 stock option plans which had an exercise price greater than $10.41, the closing price
of the Companys stock on that date. The vesting for options to purchase approximately 1.3 million
shares of common stock (of which approximately 450,000 shares were subject to options held by the
executive officers) were accelerated. Options held by non-employee directors were not accelerated.
Holders of incentive stock options (ISOs) within the meaning of Section 422 of the Internal
Revenue Code of 1986, as amended, were given the election to decline the acceleration of their
options if such acceleration would have the effect of changing the status of such option for
federal income tax purposes from an ISO to a non-qualified stock option. In addition, the
executive officers plus other members of senior management agreed that they will not sell any
shares acquired through the exercise of an accelerated option prior to the date on which the
exercise would have been permitted under the options original vesting terms. This agreement does
not apply to a) shares sold in order to pay applicable taxes resulting from the exercise of an
accelerated option or b) upon the officers retirement or other termination of employment.
The purpose of the acceleration was to eliminate any future compensation expense the Company
would have otherwise recognized in its statement of operations with respect to these options upon
the implementation of SFAS 123(R).
Other Stock-Related Information
The 2002 Stock Incentive Plan contains four separate equity programs Discretionary Option
Grant Program, Automatic Option Grant Program, Stock Issuance Program and Director Fee Option Grant
Program (the 2002
8
Plan). On January 31, 2006, shareholders of the Company approved an amendment
to the 2002 Plan to increase the number of shares of the Companys common stock authorized for
issuance by 750,000 shares, from 8.3 million shares to 9.1 million shares. As of March 31, 2006,
options for 7,370,866 shares of common stock were outstanding under the 2002 plan and 304,674
shares remained available for future option grant or direct issuance.
The Company grants options to employees, non-employees consultants, and non-employee
directors. Additionally, the Company granted restricted stock to non-employee directors in the
first quarter of 2006. Non-employee directors are accounted for as employees under SFAS 123(R).
Options and restricted stock granted to certain directors vest in equal monthly installments over one year.
Options granted to employees vests 1/8 on the six month anniversary and 1/48 each month thereafter
for forty-two months. Options granted to non-employee consultants generally vest between 24 and 36
months. All option awards generally expire ten years from the date of the 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 $0.8 million for the three months ended March 31,
2006 associated with option awards and restricted stock. Of the total compensation expense
associated with option awards, approximately $0.2 million related to options granted to
non-employee consultants.
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 March 31 |
|
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.7 |
% |
|
|
4.2 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
Expected volatility |
|
|
70 |
% |
|
|
75 |
% |
Expected term |
|
5.94 years |
|
5 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 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 equal to the expected term.
9
Stock Option Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
|
|
|
|
Exercise |
|
|
Contractual Term in |
|
|
Intrinsic Value |
|
|
|
Shares |
|
|
Price |
|
|
Years |
|
|
(in thousands) |
|
Balance at December 31, 2005 |
|
|
7,001,657 |
|
|
$ |
11.76 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
595,617 |
|
|
|
11.96 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
116,315 |
|
|
|
8.01 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
43,288 |
|
|
|
8.60 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
66,805 |
|
|
|
14.73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
7,370,866 |
|
|
$ |
11.82 |
|
|
|
6.01 |
|
|
$ |
14,273 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at March 31, 2006 |
|
|
5,671,045 |
|
|
$ |
12.44 |
|
|
|
5.11 |
|
|
$ |
9,022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options expected to vest as
of March 31, 2006 |
|
|
7,172,385 |
|
|
$ |
11.87 |
|
|
|
5.92 |
|
|
$ |
13,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of all stock options granted during the three
months ended March 31, 2006 was $7.87 per share. The total intrinsic value of all options
exercised during the three months ended March 31, 2006 was $4.69 per share. As of March 31, 2006,
there was approximately $9.0 million of total unrecognized compensation cost related to nonvested
stock options. That cost is expected to be recognized over a weighted average period of 2.91
years.
Cash received from options exercised for each of the quarters ended March 31, 2006 and 2005
was approximately $0.5 million for each period. An additional $0.5 million was received subsequent
to March 31, 2006 for options exercised during the three months ended March 31, 2006. There is no
current tax benefit related to options exercised because of net operating losses (NOLs) for which a
full valuatation allowance has been established.
Restricted Stock Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average Stock |
|
|
|
Shares |
|
|
Price |
|
Balance at December 31, 2005 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
15,566 |
|
|
|
11.56 |
|
Vested |
|
|
3,895 |
|
|
|
11.56 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2006 |
|
|
11,671 |
|
|
$ |
11.56 |
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of restricted stock granted during the three months
ended March 31, 2006 was $11.56 per share. As of March 31, 2006, there was $137,574 of total
unrecognized compensation cost related to nonvested restricted stock. That cost is expected to be
recognized over the remainder of 2006.
Employee Stock Purchase Plan
The Company also has an employee stock purchase plan (the ESPP). Since its adoption in
2002, a total of 510,248 shares of common stock have been reserved for issuance under the ESPP. As
of March 31, 2006, 362,738 shares of common stock had been issued under the ESPP, and 147,510
shares are available for future issuance. For the quarter ended March 31, 2006, there were no
issuances of common shares under the ESPP.
10
Accounts Receivable. Accounts receivable consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Trade accounts receivable |
|
$ |
2,739 |
|
|
$ |
1,344 |
|
Due from finance company (Note 2) |
|
|
18,243 |
|
|
|
20,464 |
|
Less: discounts and allowances |
|
|
(936 |
) |
|
|
(854 |
) |
|
|
|
|
|
|
|
|
|
$ |
20,046 |
|
|
$ |
20,954 |
|
|
|
|
|
|
|
|
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):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
1,655 |
|
|
$ |
1,508 |
|
Work-in-process |
|
|
8,671 |
|
|
|
9,115 |
|
Finished goods |
|
|
5,388 |
|
|
|
6,324 |
|
Less: inventory reserves |
|
|
(1,996 |
) |
|
|
(1,745 |
) |
|
|
|
|
|
|
|
|
|
|
13,718 |
|
|
|
15,202 |
|
Less: current portion |
|
|
(8,232 |
) |
|
|
(9,333 |
) |
|
|
|
|
|
|
|
Long-term portion of inventories, net |
|
$ |
5,486 |
|
|
$ |
5,869 |
|
|
|
|
|
|
|
|
In 2005, the Company completed a multi-year process of transferring its filling and finishing
of ONTAK from Eli Lilly and Company (Lilly) to Hollister-Stier. In anticipation of this transfer,
the Company used Lilly to fill and finish, in 2003, a higher than normal number of ONTAK lots each
of which required a forward dating determination. ONTAK otherwise has a shelf life projection of
up to 36 months. If commercial and clinical usage of these lots does not approximate the estimated
pattern of usage as determined for purposes of dating, the Company could be required to write-off
the value of one or more of these lots. In this regard, as of March 31, 2006 and December 31,
2005, inventory reserves relating to ONTAK finished goods inventory totaled approximately $1.1
million and $0.7 million, respectively. As of March 31, 2006 and December 31, 2005, total ONTAK
inventory amounted to approximately $7.4 million and $7.8 million, respectively, of which $3.0
million and $2.7 million is classified as long-term, respectively.
During 2005, the Company manufactured a higher than normal amount of drug substance
(bexarotene) for Targretin capsules in the event the Companys non-small cell lung cancer (NSCLC)
clinical trials were successful. In March 2005, the Company disclosed that the trials did not meet
their endpoints of improved overall survival and projected two year survival. The Company
believes, however, that the additional manufactured bexarotene, which has a shelf life projection
of approximately 10 years, will be fully used for ongoing production of the Companys marketed
products, Targretin capsules and Targretin gel. As of March 31, 2006 and December 31, 2005, total
Targretin capsules inventory amounted to $3.9 million and $4.2 million, respectively, of which $2.5
million and $3.2 million is classified as long-term, respectively.
Property and Equipment. Property and equipment is stated at cost and consists of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Land |
|
$ |
5,176 |
|
|
$ |
5,176 |
|
Equipment, building, and leasehold improvements |
|
|
61,832 |
|
|
|
61,732 |
|
Less accumulated depreciation and amortization |
|
|
(45,250 |
) |
|
|
(44,425 |
) |
|
|
|
|
|
|
|
|
|
$ |
21,758 |
|
|
$ |
22,483 |
|
|
|
|
|
|
|
|
Depreciation of equipment and building is computed using the straight-line method over the
estimated useful lives of the assets which range from three to thirty years. Leasehold
improvements are amortized using the straight-line method over their estimated useful lives or
their related lease term, whichever is shorter.
11
Other Current Assets. Other current assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred royalty cost |
|
$ |
4,947 |
|
|
$ |
5,203 |
|
Deferred cost of products sold |
|
|
4,982 |
|
|
|
5,103 |
|
Prepaid insurance |
|
|
938 |
|
|
|
1,071 |
|
Prepaid other |
|
|
2,486 |
|
|
|
2,807 |
|
Other |
|
|
3,004 |
|
|
|
1,566 |
|
|
|
|
|
|
|
|
|
|
$ |
16,357 |
|
|
$ |
15,750 |
|
|
|
|
|
|
|
|
Other Assets. Other assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Prepaid royalty buyout, net |
|
$ |
2,244 |
|
|
$ |
2,312 |
|
Debt issue costs, net |
|
|
1,598 |
|
|
|
2,193 |
|
Other |
|
|
169 |
|
|
|
199 |
|
|
|
|
|
|
|
|
|
|
$ |
4,011 |
|
|
$ |
4,704 |
|
|
|
|
|
|
|
|
Amortization of debt issue costs was $0.2 million and $0.3 million for the three months ended
March 31, 2006 and 2005, respectively. Estimated annual amortization of this asset in each of the
years in the period from 2006 through 2007 is approximately $0.9 million. As further discussed
under Long-term Debt, during the three months ended March 31, 2006, convertible notes with a face
value of $26.1 million were converted into approximately 4.2 million shares of common stock. In
connection with the conversions, unamortized debt issue costs of $0.4 million were recorded as
additional paid in capital.
Acquired Technology, Product Rights and Royalty Buy-Down, Net. 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, product rights and royalty buy-down, net as of March 31, 2006 include
payments made in 2005 totaling $33.0 million to Lilly in exchange for the elimination of the
Companys ONTAK royalty obligations in 2005 and 2006 and a reduced reverse-tiered royalty scale on
ONTAK sales in the U.S. thereafter. See Note 3 Royalty Agreements. Amounts paid to Lilly in
connection with the royalty restructuring were capitalized and are being amortized over the
remaining patent life, which is approximately 10 years and represents the period estimated to be
benefited, using the greater of the straight-line method or the expense determined on the tiered
royalty schedule as set forth in Note 3. Other acquired technology and product rights represent
payments related to
the Companys acquisition of ONTAK and license rights for AVINZA. Because the Company cannot
reliably determine the pattern in which the economic benefits of the acquired technology and
products rights are realized, acquired technology and product rights are amortized on a
straight-line basis over 15 years, which approximated the remaining patent life at the time the
assets were acquired and otherwise represents the period estimated to be benefited. Specifically,
the Company is amortizing its ONTAK asset through June 2014 which is approximate to the expiration
date of its U.S. patent of December 2014. The AVINZA asset is being amortized through November
2017, the expiration of its U.S. patent.
12
Acquired technology, product rights, and royalty buy-down, net consist of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
114,437 |
|
|
$ |
114,437 |
|
Less accumulated amortization |
|
|
(25,632 |
) |
|
|
(23,725 |
) |
|
|
|
|
|
|
|
|
|
|
88,805 |
|
|
|
90,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONTAK |
|
|
78,312 |
|
|
|
78,312 |
|
Less accumulated amortization |
|
|
(23,849 |
) |
|
|
(22,254 |
) |
|
|
|
|
|
|
|
|
|
|
54,463 |
|
|
|
56,058 |
|
|
|
|
|
|
|
|
|
|
$ |
143,268 |
|
|
$ |
146,770 |
|
|
|
|
|
|
|
|
Amortization of acquired technology, product rights and royalty buy-down, net was $3.5 million
for the three months ended March 31, 2006 and $3.2 million for the same 2005 period. Estimated
annual amortization for these assets in each of the years in the period from 2006 through 2010 is
approximately $14.0 million and a total of $76.7 million, thereafter.
Deferred Revenue, Net. Under the sell-through revenue recognition method, the Company does not
recognize revenue upon shipment of product to the wholesaler. For these shipments, the Company
invoices the wholesaler, records deferred revenue at gross invoice sales price, and classifies 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 certain
collaborative research and development payments and the sale of certain royalty rights.
The composition of deferred revenue, net is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred product revenue |
|
$ |
151,533 |
|
|
$ |
158,030 |
|
Other deferred revenue |
|
|
5,218 |
|
|
|
5,296 |
|
Deferred discounts |
|
|
(1,606 |
) |
|
|
(1,605 |
) |
|
|
|
|
|
|
|
Deferred revenue, net |
|
$ |
155,145 |
|
|
$ |
161,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, net: |
|
|
|
|
|
|
|
|
Current, net |
|
$ |
151,021 |
|
|
$ |
157,519 |
|
Long term, net |
|
|
4,124 |
|
|
|
4,202 |
|
|
|
|
|
|
|
|
|
|
$ |
155,145 |
|
|
$ |
161,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred product revenue, net (1): |
|
|
|
|
|
|
|
|
Current |
|
$ |
149,927 |
|
|
$ |
156,425 |
|
Long term |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other deferred revenue: |
|
|
|
|
|
|
|
|
Current |
|
$ |
1,094 |
|
|
$ |
1,094 |
|
Long term |
|
|
4,124 |
|
|
|
4,202 |
|
|
|
|
|
|
|
|
|
|
$ |
5,218 |
|
|
$ |
5,296 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Deferred product revenue, net does not include other gross to net revenue adjustments made
when the Company reports net product sales. Such adjustments include Medicaid rebates,
managed health care rebates, and government chargebacks, which are included in accrued
liabilities in the accompanying condensed consolidated financial statements. |
13
Accrued Liabilities. Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Allowances for loss on returns, rebates,
chargebacks, other discounts, ONTAK
end-customer and Panretin product returns |
|
$ |
14,236 |
|
|
$ |
15,729 |
|
Co-promotion |
|
|
10,807 |
|
|
|
24,778 |
|
Distribution services |
|
|
2,779 |
|
|
|
4,044 |
|
Compensation |
|
|
6,623 |
|
|
|
5,746 |
|
Royalties |
|
|
1,725 |
|
|
|
1,994 |
|
Seragen purchase liability (1) |
|
|
|
|
|
|
2,925 |
|
Interest |
|
|
2,906 |
|
|
|
1,164 |
|
Other |
|
|
4,426 |
|
|
|
3,207 |
|
|
|
|
|
|
|
|
|
|
$ |
43,502 |
|
|
$ |
59,587 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refer to Note 5. Litigation. |
The following summarizes the activity in the accrued liability accounts related to allowances
for loss on returns, rebates, chargebacks, other discounts, and ONTAK end-customer and Panretin
returns (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONTAK |
|
|
|
|
|
|
Losses on |
|
|
|
|
|
|
Managed |
|
|
|
|
|
|
End- |
|
|
|
|
|
|
Returns |
|
|
|
|
|
|
Care |
|
|
|
|
|
|
customer |
|
|
|
|
|
|
Due to |
|
|
|
|
|
|
Rebates and |
|
|
|
|
|
|
and |
|
|
|
|
|
|
Changes |
|
|
Medicaid |
|
|
Other |
|
|
Charge- |
|
|
Panretin |
|
|
|
|
|
|
In Price |
|
|
Rebates |
|
|
Rebates |
|
|
backs |
|
|
Returns |
|
|
Total |
|
Three Months Ended March
31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
December 31, 2005 |
|
$ |
4,038 |
|
|
$ |
5,348 |
|
|
$ |
3,467 |
|
|
$ |
200 |
|
|
$ |
2,676 |
|
|
$ |
15,729 |
|
Provision |
|
|
527 |
|
|
|
2,260 |
|
|
|
3,650 |
|
|
|
1,293 |
|
|
|
899 |
|
|
|
8,629 |
|
Payments |
|
|
¾ |
|
|
|
(4,853 |
) |
|
|
(1,636 |
) |
|
|
(1,276 |
) |
|
|
¾ |
|
|
|
(7,765 |
) |
Charges |
|
|
(1,856 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(501 |
) |
|
|
(2,357 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
$ |
2,709 |
|
|
$ |
2,755 |
|
|
$ |
5,481 |
|
|
$ |
217 |
|
|
$ |
3,074 |
|
|
$ |
14,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term Debt. Long-term debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
6% Convertible Subordinated Notes |
|
$ |
129,150 |
|
|
$ |
155,250 |
|
Note payable to bank |
|
|
11,753 |
|
|
|
11,839 |
|
|
|
|
|
|
|
|
|
|
|
140,903 |
|
|
|
167,089 |
|
Less current portion |
|
|
(350 |
) |
|
|
(344 |
) |
|
|
|
|
|
|
|
Long-term debt |
|
$ |
140,553 |
|
|
$ |
166,745 |
|
|
|
|
|
|
|
|
During the three months ended March 31, 2006, certain holders of the Companys outstanding 6%
convertible subordinated notes converted notes with a face value of $26.1 million into
approximately 4.2 million shares of common stock. In connection with the note conversions, accrued
interest and unamortized debt issue costs related to the converted notes, of $0.3 million and $0.4
million, respectively, were recorded to additional paid-in capital.
14
Condensed Changes in Stockholders Deficit. Condensed changes in stockholders deficit for the
three months ended March 31, 2006 are as follows (in thousands, except share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Accumulated other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
Common Stock |
|
|
paid-in |
|
|
comprehensive |
|
|
Accumulated |
|
|
Treasury Stock |
|
|
stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
capital |
|
|
income |
|
|
deficit |
|
|
Shares |
|
|
Amount |
|
|
deficit |
|
Balance at December 31,
2005 |
|
|
73,136,340 |
|
|
$ |
73 |
|
|
$ |
720,988 |
|
|
$ |
490 |
|
|
$ |
(831,059 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
(110,419 |
) |
Issuance of common stock |
|
|
131,881 |
|
|
|
1 |
|
|
|
931 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
932 |
|
Issuance of common stock
on conversion of
debt |
|
|
4,227,945 |
|
|
|
4 |
|
|
|
26,009 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
26,013 |
|
Unrealized
gains/(losses) on
available-for-sale
securities |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
534 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
534 |
|
Foreign currency
translation adjustments |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(3 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(3 |
) |
Equity- based
compensation |
|
|
¾ |
|
|
|
¾ |
|
|
|
814 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
814 |
|
Net loss |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(142,229 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
(142,229 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2006 |
|
|
77,496,166 |
|
|
$ |
78 |
|
|
$ |
748,742 |
|
|
$ |
1,021 |
|
|
$ |
(973,288 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
(224,358 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss. Comprehensive loss represents net 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 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 income as
a separate component of stockholders deficit. Comprehensive loss is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
Net loss as reported |
|
$ |
(142,229 |
) |
|
$ |
(18,472 |
) |
Unrealized
gains/losses on available-for-sale
securities |
|
|
534 |
|
|
|
(960 |
) |
Foreign currency translation adjustments |
|
|
(3 |
) |
|
|
(7 |
) |
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(141,698 |
) |
|
$ |
(19,439 |
) |
|
|
|
|
|
|
|
The components of accumulated other comprehensive income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Net unrealized holding gain on
available-for-sale securities |
|
$ |
1,277 |
|
|
$ |
743 |
|
Net unrealized loss on foreign currency
translation |
|
|
(256 |
) |
|
|
(253 |
) |
|
|
|
|
|
|
|
|
|
$ |
1,021 |
|
|
$ |
490 |
|
|
|
|
|
|
|
|
Net Product Sales. The Companys domestic net product sales for AVINZA, ONTAK, Targretin capsules
and Targretin gel are determined on a sell-through basis less allowances for rebates, chargebacks,
discounts, and losses to be incurred on returns from wholesalers resulting from increases in the
selling price of the Companys products. The Company recognizes revenue for Panretin upon shipment
to wholesalers as the Companys wholesaler customers only stock minimal amounts of Panretin, if
any. As such, wholesaler orders are considered to approximate end-customer demand for the product.
Revenues from sales of Panretin are net of allowances for rebates, chargebacks, returns and
discounts. For international shipments of the Companys product, revenue is recognized upon
shipment to the Companys third-party international distributors. In addition, the Company incurs
certain distributor service
15
agreement fees related to the management of its product by wholesalers.
These fees have been recorded within net product sales. For ONTAK, the Company also has
established reserves for returns from end customers (i.e. other than wholesalers) after
sell-through revenue recognition has occurred.
A summary of the revenue recognition policy used for each of the Companys products and the
expiration of the underlying patents for each product is as follows:
|
|
|
|
|
|
|
|
|
|
|
Revenue Recognition |
|
Patent |
|
|
Method |
|
Event |
|
Expiration |
AVINZA
|
|
Sell-through
|
|
Prescriptions
|
|
November 2017 |
ONTAK
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
December 2014 |
Targretin capsules
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Targretin gel
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Panretin
|
|
Sell-in
|
|
Shipment to wholesaler
|
|
August 2016 |
International
|
|
Sell-in
|
|
Shipment to
international
distributor
|
|
February 2011
through April 2013 |
For the three months ended March 31, 2006 and 2005, net product sales recognized under the
sell-through method represented approximately 96% of total net product sales in both periods.
The Companys total net product sales for the three months ended March 31, 2006 were $48.0
million compared to $35.0 million for the same 2005 period. A comparison of sales by product is as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
32,495 |
|
|
$ |
21,997 |
|
ONTAK |
|
|
9,182 |
|
|
|
8,024 |
|
Targretin capsules |
|
|
5,002 |
|
|
|
4,015 |
|
Targretin gel and Panretin gel
|
|
|
1,305 |
|
|
|
1,009 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
47,984 |
|
|
$ |
35,045 |
|
|
|
|
|
|
|
|
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 March 31, |
|
|
|
2006 |
|
|
2005 |
|
Collaborative research and development |
|
$ |
894 |
|
|
$ |
862 |
|
Development milestones and other |
|
|
2,078 |
|
|
|
1,078 |
|
|
|
|
|
|
|
|
|
|
$ |
2,972 |
|
|
$ |
1,940 |
|
|
|
|
|
|
|
|
16
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. At March 31,
2006 and December 31, 2005, the Company has established a full valuation allowance against net
deferred tax assets.
2. Accounts Receivable Factoring Arrangement
During 2003, the Company entered into a one-year accounts receivable factoring arrangement
under which eligible accounts receivable are 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 months ended
March 31, 2006 and 2005 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.
As of March 31, 2006 and December 31, 2005, the Company had received cash of $19.8 million and
$23.3 million, respectively, under the factoring arrangement for the sale of trade receivables that
were outstanding as of such dates. The gross amount due from the finance company at March 31, 2006
and December 31, 2005 was $18.2 million and $20.5 million, respectively.
3. Royalty Agreements
Restructuring of ONTAK Royalty
In November 2004, Ligand and Eli Lilly and Company (Lilly) agreed to amend their ONTAK royalty
agreement to add options in 2005 that if exercised would restructure Ligands royalty obligations
on net sales of ONTAK. Under the revised agreement, Ligand and Lilly each obtained two options.
Ligands options, which were exercised, provided for the buy-down of a portion of the Companys
ONTAK royalty obligation on net sales in the United States for total consideration of $33.0
million. Lilly also had two options exercisable in July 2005 and October 2005 to trigger the same
royalty buy-downs for total consideration of up to $37.0 million, dependent on whether Ligand had
exercised one or both of its options.
Ligands first option, providing for a one-time payment of $20.0 million to Lilly in exchange
for the elimination of Ligands ONTAK royalty obligations in 2005 and a reduced reverse-tiered
royalty scale on ONTAK sales in the U.S. thereafter, was exercised in January 2005. The second
option which provided for a one-time payment of $13.0 million to Lilly in exchange for the
elimination of royalties on ONTAK net sales in the U.S. in 2006 and a reduced reverse-tiered
royalty thereafter was exercised in April 2005. Additionally, beginning in 2007 and throughout the
remaining ONTAK patent life (2014), Ligand will pay no royalties to Lilly on U.S. sales up to $38.0
million. Thereafter, Ligand will pay royalties to Lilly at a rate of 20% on net U.S. sales between
$38.0 million and $50.0 million; at a rate of 15% on net U.S. sales between $50.0 million and $72.0
million; and at a rate of 10% on net U.S. sales in excess of $72.0 million. The option payments
totaling $33.0 million were capitalized and are being amortized over the remaining ONTAK patent
life of approximately 10 years, which
represents the period estimated to be benefited, using the greater of the straight-line method
or the expense determined based on the tiered
17
royalty schedule set forth above. 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.
Buyout of Salk Royalty Obligations
In January 2005, Ligand paid Salk $1.1 million to exercise an option to buy out milestone
payments, other payment-sharing obligations and royalty payments due on future sales of
lasofoxifene for vaginal atrophy. This payment resulted from a supplemental lasofoxifene new drug
application (NDA) filing by Pfizer. As the Company had previously sold rights to Royalty Pharma AG
of approximately 50% of any royalties to be received from Pfizer for sales of lasofoxifene, it
recorded approximately 50% of the payment made to Salk, approximately $0.6 million, as development
expense in the first quarter of 2005. The balance of approximately $0.5 million was capitalized to
be amortized over the period any such royalties were to be received from Pfizer for the vaginal
atrophy indication. In connection with Pfizers receipt of a non-approvable letter from the FDA
for the vaginal atrophy indication in February 2006, however, the Company wrote-off the remaining
capitalized balance of $0.5 million in the fourth quarter of 2005.
Settlement of Patent Interference
In March 2005, Ligand announced that it reached a settlement agreement in a patent
interference action initiated by Ligand against two patents owned by The Burnham Institute and SRI
International, but exclusively licensed to Ligand. The Company believes the settlement strengthens
its intellectual property position for bexarotene, the active ingredient in the Targretin products.
The settlement also reduces the royalty rate on those products while extending the royalty payment
term to SRI/Burnham.
Under the agreement, Burnham has a research-only sublicense to conduct basic research under
the assigned patents and Ligand will have an option on the resulting products and technology. In
addition, Burnham and SRI agreed to accept a reduction in the royalty rate paid to them on U.S.
sales of Targretin under an earlier agreement. The aggregate royalty rate owed to SRI and Burnham
by Ligand was reduced from 4% to 3% of net sales and the term of the royalty payments extended from
2012 to 2016. If the patent issued on the pending Ligand patent application is extended beyond
2016, the royalty rate would be reduced to 2% and paid for the term of the longest Ligand patent
covering bexarotene.
4. 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. Under the terms of the agreement,
Organon committed to a specified minimum number of primary and secondary product calls delivered to
certain high prescribing physicians and hospitals beginning in March 2003. Organons compensation
was structured as a percentage of net sales based on generally accepted accounting principles
(GAAP), which paid Organon for their efforts and also provided Organon an economic incentive for
performance and results. In exchange, Ligand paid Organon a percentage of AVINZA net sales based
on the following schedule:
|
|
|
|
|
|
|
|
|
|
|
% of Incremental Net Sales |
Annual Net Sales of AVINZA |
|
|
|
Paid to Organon by Ligand |
$0-150 million
|
|
|
|
30% (0% for 2003)
|
$150-300 million
|
|
|
|
|
40 |
% |
$300-425 million
|
|
|
|
|
50 |
% |
> $425 million
|
|
|
|
|
45 |
% |
In January 2006, Ligand signed an agreement with Organon that terminated the AVINZA
co-promotion agreement between the two companies and returns AVINZA co-promotion rights to Ligand.
The effective date of
the termination agreement is January 1, 2006; however, the parties have agreed to continue to
cooperate during a transition period ending September 30, 2006 (the Transition Period) to promote
the product. The Transition Period
18
co-operation includes a minimum number of product sales calls
per quarter (100,000 for Organon and 30,000 for Ligand with an aggregate of 375,000 and 90,000,
respectively, for the Transition Period) 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 will pay Organon an amount equal to 23% of AVINZA net sales as reported
by Ligand. Ligand will also pay and be 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 will unconditionally pay Organon $37.75 million on or before October 15,
2006. Ligand will further pay Organon $10.0 million on or before January 15, 2007, provided that
Organon has made its minimum required level of sales calls. Under certain conditions, including
change of control, the cash payments will accelerate. In addition, after the termination, Ligand
will make quarterly 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 $37.75 million to Organon and the estimated fair value of the
amounts to be paid to Organon after the termination
($98.5 million and $95.2 million as of March 31, 2006
and January 1, 2006, respectively), based on
the 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 agreement during the
Transition Period (when the provision to pay 23% of AVINZA net sales is also considered), is being
recognized ratably as additional co-promotion expense over the Transition Period. For the three
months ended March 31, 2006, the pro-rata recognition of this element of co-promotion expense
amounted to $3.3 million.
Although the quarterly payments to Organon will be based on net reported AVINZA product sales,
such payments will not result in current period expense in the period upon which the payment is
based, but instead will be charged against the co-promote termination liability. The accretion to
the current net present value for each reporting period will, however, be recognized as other
non-operating expense (interest expense) for that period at a rate of 15%, the discount rate used
to initially value this component of the termination liability. Additionally, any changes to the
Companys estimates of future net AVINZA product sales will result in a change to the liability
which will be recognized as an increase or decrease to earnings in the period such changes are
identified. Accreted interest expense for the three months ended March 31, 2006 was $3.3 million.
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 liability may be materially different
from its current estimates. In addition, because of the inherent difficulties of predicting
possible changes to the estimates and assumptions used to determine the estimate of future AVINZA
product sales, the Company is unable to quantify an estimate of the reasonably likely effect of any
such changes on its results of operations or financial position.
The components of the co-promote termination liability as of March 31, 2006 are as follows (in
thousands):
|
|
|
|
|
Payment due October 15, 2006 |
|
$ |
37,750 |
|
Net present value of payments based on
net AVINZA product sales as of January 1, 2006 |
|
|
95,191 |
|
Accretion of
interest to net present value of payments based on net AVINZA product
sales as of March 31, 2006 |
|
|
3,300 |
|
|
|
|
|
|
|
|
136,241 |
|
|
|
|
|
|
Less: current portion of co-promote termination liability |
|
|
(42,533 |
) |
|
|
|
|
Long-term portion of co-promote
termination liability |
|
$ |
93,708 |
|
|
|
|
|
19
5. Litigation
The Companys subsidiary, Seragen, Inc. and Ligand, were named parties to Sergio M. Oliver, et
al. v. Boston University, et al., a putative 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 March 31, 2006, 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.
Beginning in August 2004, several purported class action stockholder lawsuits were filed in
the United States District Court for the Southern District of California against the Company and
certain of its directors and officers. The actions were brought on behalf of purchasers of the
Companys common stock during several time periods, the longest of which runs from July 28, 2003
through August 2, 2004. The complaints generally allege that the Company violated Sections 10(b)
and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 of the Securities and Exchange
Commission by making false and misleading statements, or concealing information about the Companys
business, forecasts and financial performance, in particular statements and information related to
drug development issues and AVINZA inventory levels. These lawsuits have been consolidated and
lead plaintiffs appointed. A consolidated complaint was filed by the plaintiffs in March 2005. On
September 27, 2005, the court granted the Companys motion to dismiss the consolidated complaint,
with leave for plaintiffs to file an amended complaint within 30 days. In December 2005, the
plaintiffs filed a second amended complaint again alleging claims under Section 10(b) and 20(a) of
the Securities Exchange Act against the Company, David Robinson and Paul Maier. The amended
complaint asserts an expanded Class Period of March 19, 2001 through May 20, 2005 and includes
allegations arising from the Companys announcement on May 20, 2005 that it would restate certain
financial results. Defendants filed their motion to dismiss plaintiffs second amended complaint
in January 2006. No trial date has been set.
Beginning on or about August 13, 2004, several derivative actions were filed on behalf of the
Company by individual stockholders in the Superior Court of California. The complaints name the
Companys directors and certain of its officers as defendants and name the Company as a nominal
defendant. The complaints are based on the same facts and circumstances as the purported class
actions discussed in the previous paragraph and generally allege breach of fiduciary duties, abuse
of control, waste and mismanagement, insider trading and unjust enrichment. These actions are in
discovery. The court has set a trial date of November 17, 2006.
In October 2005, a shareholder derivative action was filed on behalf of the Company in the
United States District Court for the Southern District of California. The complaint names the
Companys directors and certain of its officers as defendants and the Company as a nominal
defendant. The action was brought by an individual stockholder. The complaint generally alleges
that the defendants falsified Ligands publicly reported financial
results throughout 2002 and 2003 and the first three quarters of 2004 by improperly
recognizing revenue on product sales. The complaint generally alleges breach of fiduciary duty by
all defendants and requests disgorgement, e.g.,
20
under Section 304 of the Sarbanes-Oxley Act of
2002. In January 2006, the defendants filed a motion to dismiss plaintiffs verified shareholder
derivative complaint. Plaintiffs opposition was filed in February 2006. No trial date has been
set.
The Company believes that all of the above actions are without merit and intends to vigorously
defend against each of such lawsuits. Due to the uncertainty of the ultimate outcome of these
matters, the impact on future financial results is not subject to reasonable estimates.
On December 11, 2001, a lawsuit was filed in the United States District Court for the District
of Massachusetts against Ligand by the Trustees of Boston University and other former stakeholders
of Seragen. The suit was subsequently transferred to federal district court in Delaware. The
complaint alleged breach of contract, breach of the implied covenants of good faith and fair
dealing and unfair and deceptive trade practices based on, among other things, allegations that
Ligand wrongfully withheld approximately $2.1 million in consideration due the plaintiffs under the
Seragen acquisition agreement. This amount had been previously accrued for in the Companys
consolidated financial statements in 1998. The complaint sought payment of the withheld
consideration and treble damages. Ligand filed a motion to dismiss the unfair and deceptive trade
practices claim. The Court subsequently granted Ligands motion to dismiss the unfair and
deceptive trade practices claim (i.e., the treble damages claim), in April 2003. In November 2003,
the Court granted Boston Universitys motion for summary judgment, and entered judgment for Boston
University. In January 2004, the district court issued an amended judgment awarding interest of
approximately $0.7 million to the plaintiffs in addition to the approximately $2.1 million
withheld. In January 2006, the appeals court affirmed the district courts ruling against Ligand.
Additional interest on the above amounts of approximately $0.1 million was accrued through January
2006 and was added to the judgment. The withheld amount including the interest was paid in
February 2006.
The
SEC instituted a formal investigation, which is ongoing, concerning the restatement of the Companys
consolidated financial statements for the years ended 2002 and 2003 (including the 2003 and 2004
quarterly periods). Such restatement was completed in 2005. These matters were previously the
subject of an informal SEC inquiry.
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.
6. New Accounting Pronouncements
In November 2005, the FASB issued Staff Position (FSPs) Nos. FSPs 115-1 and 124-1, The Meaning
of Other-Than-Temporary Impairment and Its Application to Certain Investments, in response to EITF
03-1, The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments
(EITF 03-1). FSPs 115-1 and 124-1 provide guidance regarding the determination as to when an
investment is considered impaired, whether that impairment is other-than-temporary, and the
measurement of an impairment loss. FSPs 115-1 and 124-1 also include accounting considerations
subsequent to the recognition of an other-than-temporary impairment and requires certain
disclosures about unrealized losses that have not been recognized as other-than
temporary-impairments. These requirements are effective for annual reporting periods beginning
after December 15, 2005. Adoption of the impairment guidance contained in FSPs 115-1 and 124-1 did
not have a material impact on the Companys consolidated financial position or results of
operations.
In November 2004, the FASB issued SFAS No. 151, Inventory Pricing (SFAS 151). SFAS 151 amends
the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to clarify the accounting for abnormal
amounts of idle facility expense, freight, handling costs, and wasted material (spoilage). This
statement requires that those items be recognized as current-period charges. In addition, SFAS 151
requires that allocation of fixed production overheads to the costs of conversion be based on the
normal capacity of the production facilities. This statement is
effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The
adoption of SFAS No. 151 did not have a material impact on the Companys results of operations or
financial position.
21
In December 2004, the FASB issued SFAS No. 153, Exchanges of Nonmonetary Assets, to address
the measurement of exchanges of nonmonetary assets. It eliminates the exception from fair value
measurement for nonmonetary exchanges of similar productive assets in APB No. 29, Accounting for
Nonmonetary Transactions, and replaces it with an exception for nonmonetary exchanges that do not
have commercial substance. This statement specifies that a nonmonetary exchange has commercial
substance if the future cash flows of the entity are expected to change significantly as a result
of the exchange. This statement is effective for nonmonetary asset exchanges occurring in fiscal
periods beginning after June 15, 2005. The adoption of SFAS No. 153 did not have a material impact
on the Companys results of operations or financial position.
In May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error Corrections (SFAS
154). SFAS 154 requires retrospective application to prior-period financial statements of changes
in accounting principles, unless it is impracticable to determine either the period-specific
effects or the cumulative effect of the change. SFAS 154 also redefines restatement as the
revising of previously issued financial statements to reflect the correction of an error. This
statement is effective for accounting changes and corrections of errors made in fiscal years
beginning after December 15, 2005.
In February 2006, the FASB issued SFAS No. 155, Accounting for Certain Hybrid Financial
Instruments (SFAS 155) which amends SFAS No. 133, Accounting for Derivative Instruments and Hedging
Activities (SFAS 133) and SFAS 140, Accounting or the Impairment or Disposal of Long-Lived Assets
(SFAS 140). Specifically, SFAS 155 amends SFAS 133 to permit fair value remeasurement for any
hybrid financial instrument with an embedded derivative that otherwise would require bifurcation,
provided the whole instrument is accounted for on a fair value basis. Additionally, SFAS 155
amends SFAS 140 to allow a qualifying special purpose entity to hold a derivative financial
instrument that pertains to a beneficial interest other than another derivative financial
instrument. SFAS 155 applies to all financial instruments acquired or issued after the beginning
of an entitys first fiscal year that begins after September 15, 2006, with early application
allowed. The adoption of SFAS 155 is not expected to have a material impact on the Companys
results of operations or financial position.
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets
(SFAS 156) to simplify accounting for separately recognized servicing assets and servicing
liabilities. SFAS 156 amends SFAS No. 140, Accounting for Transfers and Servicing of Financial
Assets and Extinguishments of Liabilities. Additionally, SFAS 156 applies to all separately
recognized servicing assets and liabilities acquired or issued after the beginning of an entitys
fiscal year that begins after September 15, 2006, although early adoption is permitted. The
adoption of SFAS 156 is not expected to have a material impact on the Companys results of
operations or financial position.
7. Commitments and Contingencies
Stockholders Agreement
In October 2005, a lawsuit was filed in the Court of Chancery in the State of Delaware by
Third Point Offshore Fund, Ltd. requesting the Court to order Ligand to hold an annual meeting for
the election of directors within 60 days of an order by the Court. Ligands annual meeting had
been delayed as a result of the previously announced restatement. The complaint sought payment of
plaintiffs costs and attorneys fees. Ligand agreed on November 11, 2005 to settle this lawsuit
and schedule the annual meeting for January 31, 2006. On December 2, 2005, Ligand and Third Point
also entered into a stockholders agreement under which, among other things, Ligand agreed to expand
its board from eight to eleven, elect three designees of Third Point to the new board seats and pay
certain of Third Points expenses, not to exceed approximately $0.5 million. Of such amount,
approximately 50% was expensed in the fourth quarter of 2005. Any additional payments will only be
made if a definitive document arising out of or related to the Companys strategic evaluation
process has not been executed by the Company on or before June 2, 2006. Third Point will not sell
its Ligand shares, solicit proxies or take certain other stockholder
actions for a minimum of six months (i.e. through June 2, 2006) and as long as its designees
remain on the board.
8. Employee Retention Agreements
In March 2006, the Company entered into letter agreements with approximately 67 of its key
employees, including a number of its executive officers. These letter agreements provide for
certain retention or stay bonus
22
payments in cash under specified circumstances as an additional
incentive to remain employed in good standing with the Company. The Compensation Committee of the
Board of Directors has approved the Companys entry into these agreements. The retention or stay
bonus payments generally vest at the end of 2006 and total payments to employees of approximately
$2.7 million would be made in January 2007 if all participants qualify for the payments. In
accordance with Statement of Financial Accounting Standard (SFAS) 146, Accounting for Costs
Associated with Exit or Disposal Activities, the cost of the plan is ratably accrued over the term
of the agreements, which is approximately 10 months. For the three months ended March 31, 2006,
the Company recognized approximately $0.3 million of expense under the plan. As an additional
retention incentive, certain employees were also granted stock options totaling approximately
122,000 shares at an exercise price of $11.90 per share.
9. Subsequent Event
In May 2006, after review of all preclinical and clinical data including recently completed
two year animal safety studies, Lilly informed the Company that it had decided not to pursue
further development at this time of LY818 (Naveglitazar), a compound in Phase II development for
the treatment of Type II diabetes. Naveglitazar, a dual PPAR agonist was developed through the
Companys collaborative research and development agreement with Lilly. This decision is specific
with regard to Naveglitizar and does not affect the ongoing development activities of LY 674 or
the status of preclinical PPAR agonists.
23
|
|
|
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 Part II. Item 1A. Risk Factors. This outlook represents our current judgment on
the future direction of our business. These statements include those related to our products,
product sales and other revenues, expenses, our revenue recognition models and policies, material
weaknesses or deficiencies in internal control over financial reporting, revenue recognition, the
potential relisting of the Companys securities on NASDAQ, and our evaluation of strategic
alternatives. Actual events or results may differ materially from Ligands expectations. For
example, there can be no assurance that our product sales efforts or recognized 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,
that we will be relisted on the NASDAQ on any given timeframe or at all, or that our strategic
evaluation process will be successful or yield preferred results. We cannot assure you that the
Company will be able to successfully remediate any identified material weakness or significant
deficiencies, or that the sell-through revenue recognition models will not require adjustment and
not result in a subsequent restatement. In addition, the Companys ongoing or future litigation
(including private securities litigation and the SEC investigation) may have an adverse effect on
the Company, and our corporate or partner pipeline products may not gain approval or success in the
market. 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
Ò AVINZA Ò , ONTAK Ò ,
Panretin Ò and Targretin Ò . 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 discover, develop and market drugs that address patients critical unmet medical needs in
the areas of cancer, pain, mens and womens health or hormone-related health issues, skin
diseases, osteoporosis, blood disorders and metabolic, cardiovascular and inflammatory diseases.
Our drug discovery and development programs are based on our proprietary gene transcription
technology, primarily related to Intracellular Receptors, also known as IRs, a type of sensor or
switch inside cells that turns genes on and off, and Signal Transducers and Activators of
Transcription, also known as STATs, which are another type of gene switch.
We currently market five products in the United States: AVINZA, for the relief of chronic,
moderate to severe pain; ONTAK, for the treatment of patients with persistent or recurrent
cutaneous T-cell lymphoma (CTCL); Targretin capsules, for the treatment of CTCL in patients who are
refractory to at least one prior systemic therapy; Targretin gel, for the topical treatment of
cutaneous lesions in patients with early stage CTCL; and Panretin gel, for the treatment of
Kaposis sarcoma in AIDS patients. In Europe, we have marketing authorizations for
PanretinÒ gel and Targretin capsules and are currently marketing these products
under arrangements with local distributors. In April 2003, we withdrew our ONZARä (ONTAK in
the U.S.) marketing authorization application in Europe for our first generation product. It was
our assessment that the cost of the additional clinical and technical information requested by the
European Agency for the Evaluation of Medicinal Products (EMEA) for the first generation product
would be better spent on acceleration of the second generation ONTAK formulation development. We
expect to resubmit the ONZARä application with the second generation product in 2007.
24
In February 2003, we entered into an agreement for the co-promotion of AVINZA with Organon
Pharmaceuticals USA Inc. (Organon). Under the terms of the agreement, Organon committed to a
specified minimum number of primary and secondary product calls delivered to certain high
prescribing physicians and hospitals beginning in March 2003. Organons compensation through 2005
was structured as a percentage of net sales, which paid Organon for their efforts and also provided
Organon an economic incentive for performance and results. In exchange, we paid Organon a
percentage of AVINZA net sales based on the following schedule:
|
|
|
|
|
|
|
|
|
|
|
% of Incremental Net Sales |
Annual Net Sales of AVINZA |
|
|
|
Paid to Organon by Ligand |
$0-150 million
|
|
|
|
30% (0% for 2003)
|
$150-300 million
|
|
|
|
|
40 |
% |
$300-425 million
|
|
|
|
|
50 |
% |
> $425 million
|
|
|
|
|
45 |
% |
In January 2006, we signed an agreement with Organon that terminated the AVINZA co-promotion
agreement between the two companies and returns AVINZA rights to Ligand. The effective date of the
termination agreement is January 1, 2006; however, the parties have agreed to continue to cooperate
during a transition period ending September 30, 2006 (the Transition Period) to promote the
product. The Transition Period co-operation includes a minimum number of product sales calls per
quarter (100,000 for Organon and 30,000 for Ligand with an aggregate of 375,000 and 90,000,
respectively, for the Transition Period) 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 will pay Organon an amount equal to 23% of AVINZA net sales as reported. We
will also pay and be responsible for the design and execution of all AVINZA clinical, advertising
and promotion expenses and activities.
As previously disclosed, Organon and Ligand were in discussions regarding the calculation of
prior co-promote fees under the co-promotion agreements. Through the third quarter of 2005, such
fees were determined based on net sales calculated under the sell-in method of revenue recognition.
In connection with the termination of the co-promotion agreement, the companies resolved their
disagreement concerning prior co-promote fees and we paid Organon $14.75 million in January 2006.
Resolution of this matter resulted in no material adjustment to amounts previously recorded in 2005
for co-promotion expenses.
Additionally, in consideration of the early termination and return of co-promotion rights
under the terms of the agreement, we will unconditionally pay Organon $37.75 million on or before
October 15, 2006. We will further pay Organon $10.0 million on or before January 15, 2007,
provided that Organon has made its minimum required level of sales calls. Under certain conditions,
including change of control, the cash payments will accelerate. In addition, after the
termination, we will make quarterly 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 2017.
The unconditional payment of $37.75 million to Organon and the estimated fair value of the
amounts to be paid to Organon after the termination ($98.5 million as of March 31, 2006), based on
the 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 agreement during the
Transition Period (when the provision to pay 23% of AVINZA net sales is also considered), is being
recognized ratably as additional co-promotion expense over the Transition Period. For the three
months ended March 31, 2006, the pro-rata recognition of this element of co-promotion expense
amounted to $3.3 million.
Although the quarterly payments to Organon will be based on net reported AVINZA product sales,
such payments will not result in current period expense in the period upon which the payment is
based, but instead will be charged against the co-promote termination liability. The accretion to
the current net present value for each reporting period will, however, be recognized as other,
non-operating expense (interest expense) for that period at a rate of 15%, the discount rate used
to initially value this component of the termination liability. Accreted interest
25
expense for the
three months ended March 31, 2006 totaled $3.3 million. Additionally, any changes to our estimates
of future net AVINZA product sales will result in a change to the liability which will be
recognized as an increase or decrease to earnings in the period such changes are identified. Any
such changes could be material and potentially result in adjustments to our consolidated statement
of operations that are inconsistent with the underlying trend in net AVINZA product sales.
We are currently involved in the research phase of a research and development collaboration
with TAP Pharmaceutical Products Inc. (or TAP). Collaborations in the development phase are being
pursued by Eli Lilly and Company, GlaxoSmithKline, Organon, Pfizer, TAP, and Wyeth. We receive
funding during the research phase of the arrangements and milestone and royalty payments as
products are developed and marketed by our corporate partners. 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. We achieved quarterly net
income of $17.3 million during the fourth quarter of fiscal 2004, which was primarily the result of
recognizing approximately $31.3 million from the sale of royalty rights to Royalty Pharma.
However, we have incurred a net loss in each of the subsequent quarters including the three months
ended March 31, 2006, for which we incurred a net loss of $142.2 million. We expect to incur net
losses in the future. To be consistently profitable, we must successfully develop, clinically
test, market and sell our products. Even if we consistently 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 of revenues earned from product sales, expenses incurred, collaborative arrangements
and other sources. Some of these fluctuations may be significant.
Recent Developments
Accounting for Stock-Based Compensation
Effective January 1, 2006, we adopted SFAS 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. Under the
modified prospective transition method, compensation cost recognized in 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 in the first quarter 2006,
based on grant-date fair value estimated in accordance with the provisions of SFAS 123(R). Results
for the quarter ended March 31, 2005 have not been retrospectively adjusted. The implementation of
SFAS 123(R) resulted in employee compensation expense of approximately $0.6 million for the three
months ended March 31, 2006.
Termination of Organon Co-promotion Agreement
As further discussed under Overview above, in January 2006, we signed an agreement with
Organon that terminates the AVINZA co-promotion agreement between the two companies and returns
AVINZA rights to Ligand.
Restructuring of AVINZA Sales Force
In January 2006, 18 Ligand sales representatives previously promoting AVINZA to primary care
physicians were redeployed to call on pain specialists and all Ligand primary care territories were
eliminated. In connection with this restructuring, 11 primary-care sales representatives were
terminated. The AVINZA sales force restructuring was implemented to improve sales call coverage
and effectiveness among high prescribing pain specialists.
Conversion of 6% Convertible Subordinated Notes
For the three months ended March 31, 2006, certain holders of our 6% convertible subordinated
notes converted notes with a face value of $26.1 million into approximately 4.2 million shares of
common stock.
26
Employee Retention Agreements
As of March 1, 2006, we entered into letter agreements with approximately 67 of our key
employees, including a number of our executive officers. These letter agreements provide 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. The Compensation
Committee of the Board of Directors has approved the Companys entry into these agreements. The
retention or stay bonus payments generally vest at the end of 2006 and total payments to employees
of approximately $2.7 million would be made in January 2007 if all participants qualify for the
payments. In accordance with the Statement of Financial Accounting Standard (SFAS) 146, Accounting
for Costs Associated with Exit or Disposal Activities, the cost of the plan is ratably accrued over
the term of the agreements, which is approximately 10 months. For the three months ended March 31,
2006, the Company recognized approximately $0.3 million of expense under the plan. As an
additional retention incentive, certain employees were also granted stock options totaling
approximately 122,000 shares at an exercise price of $11.90 per share.
LY818 (Naveglitazar)
In May 2006, after review of all preclinical and clinical data including recently completed
two year animal safety studies, Lilly informed us that it had decided not to pursue further
development at this time of LY818 (Naveglitazar), a compound in Phase II development for the
treatment of Type II diabetes. Naveglitazar, a dual PPAR agonist was developed through our
collaborative research and development agreement with Lilly. This decision is specific with regard
to Naveglitizar and does not affect the ongoing development
activities of LY 674 or the status of
preclinical PPAR agonists.
Results of Operations
Total revenues for the three months ended March 31, 2006 were $51.0 million compared to $37.0
million for the same 2005 period. Loss from operations was $137.1 million for the three months
ended March 31, 2006 compared to $15.8 million for the same 2005 period. Net loss for the three
months ended March 31, 2006 was $142.2 million ($1.84 per share) compared to $18.5 million ($0.25
per share) for the same 2005 period.
Product Sales
Our product sales for any individual period can be influenced by a number of factors including
changes in demand for a particular product, competitive products, the timing of announced price
increases, and the level of prescriptions subject to rebates and chargebacks.
According to IMS data, quarterly prescription market share of AVINZA for the three months
ended March 31, 2006 was 4.0% compared to 4.4% for the fourth quarter of 2005 and the same 2005
period. We expect that AVINZA prescription market share for the remainder of 2006 will reflect
modest, if any, overall share growth in 2006 as market share increases in the commercial retail
sector are increasingly offset by declines in the Medicaid segment as marginal Medicaid contracts
are terminated. Quarter to quarter declines in prescriptions and overall market share, however,
may result from more rapid declines in the Medicaid segment relative to increases in the commercial
retail sector.
We also expect that demand for and sales of ONTAK will be positively impacted as further data
is obtained from ongoing expanded-use clinical trials and the initiation of new expanded-use
trials. The level and timing of any such increases, however, are influenced by a number of factors
outside our control, including the accrual of patients and overall progress of clinical trials that
are managed by third parties. We also expect that sales of ONTAK will continue to benefit in 2006
from improving reimbursement rates under certain government reimbursement programs.
Excluding AVINZA, our products are small-volume specialty pharmaceutical products that address
the needs of cancer patients in relatively small niche markets with substantial geographical
fluctuations in demand. To ensure patient access to our drugs, we maintain broad distribution
capabilities with inventories held at approximately 130 locations throughout the United States.
The purchasing and stocking patterns of our wholesaler customers for all our products are
influenced by a number of factors that vary from product to product. These factors include, but
are not
27
limited to, overall level of demand, periodic promotions, required minimum shipping
quantities and wholesaler competitive initiatives. If any or all of our major wholesalers decide
to reduce the inventory they carry in a given period (subject to the terms of our wholesaler
fee-for-service agreements), our shipments and cash flow for that period could be substantially
lower than historical levels.
Certain of our products are included on the formularies (or lists of approved and reimbursable
drugs) of many states health care plans, as well as the formulary for certain Federal government
agencies. In order to be placed on these formularies, we generally sign contracts which provide
discounts to the purchaser off the then-current list price and limit how much of an annual price
increase we can implement on sales to these groups. As a result, the discounts off list price for
these groups can be significant for products where we have implemented list price increases. We
monitor the portion of our sales subject to these discounts, and accrue for the cost of these
discounts at the time of the recognition of product sales. We believe that by being included on
these formularies, we will gain better physician acceptance, which will then result in greater
overall usage of our products. If the relative percentage of our sales subject to these discounts
increases materially in any period, our sales and gross margin could be substantially lower than
historical levels.
Net Product Sales
Our domestic net product sales for AVINZA, ONTAK, Targretin capsules and Targretin gel are
determined on a sell-through basis less allowances for rebates, chargebacks, discounts, and losses
to be incurred on returns from wholesalers resulting from increases in the selling price of our
products. We recognize revenue for Panretin upon shipment to wholesalers as our wholesaler
customers only stock minimal amounts of Panretin, if any. As such, wholesaler orders are
considered to approximate end-customer demand for the product. Revenues from sales of Panretin are
net of allowances for rebates, chargebacks, returns and discounts. For international shipments of
our product, revenue is recognized upon shipment to our third-party international distributors. In
addition, we incur certain distributor service agreement fees related to the management of our
product by wholesalers. These fees have been recorded within net product sales. For ONTAK, we
also have established reserves for returns from end customers (i.e. other than wholesalers) after
sell-through revenue recognition has occurred.
A summary of the revenue recognition policy used for each of our products and the expiration
of the underlying patents for each product is as follows:
|
|
|
|
|
|
|
|
|
|
|
Revenue Recognition |
|
Patent |
|
|
Method |
|
Event |
|
Expiration |
AVINZA
|
|
Sell-through
|
|
Prescriptions
|
|
November 2017 |
ONTAK
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
December 2014 |
Targretin capsules
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Targretin gel
|
|
Sell-through
|
|
Wholesaler out-movement
|
|
October 2016 |
Panretin
|
|
Sell-in
|
|
Shipment to wholesaler
|
|
August 2016 |
International
|
|
Sell-in
|
|
Shipment to
international
distributor
|
|
February 2011
through April 2013 |
For the three months ended March 31, 2006 and 2005, net product sales recognized under the
sell-through method represented 96% of total net product sales for both periods.
Our total net product sales for the three months ended March 31, 2006 were $48.0 million
compared to $35.0 million for the same 2005 period. A comparison of sales by product is as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
32,495 |
|
|
$ |
21,997 |
|
ONTAK |
|
|
9,182 |
|
|
|
8,024 |
|
Targretin capsules |
|
|
5,002 |
|
|
|
4,015 |
|
Targretin gel and Panretin gel |
|
|
1,305 |
|
|
|
1,009 |
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
47,984 |
|
|
$ |
35,045 |
|
|
|
|
|
|
|
|
28
AVINZA
Sales of AVINZA were $32.5 million for the three months ended March 31, 2006 compared to $22.0
million for the same 2005 period. The increase in sales in the 2006 period reflects a 4.7%
increase in prescriptions and the impact of a 7% price increase effective April 1, 2005, as well as
a shift in the mix of prescriptions to the higher doses of AVINZA. Net AVINZA sales in the 2006
period also reflect a reduction in Medicaid rebates of approximately $2.5 million partially offset
by an increase in managed care rebates of approximately $1.4 million, under contracts with pharmacy
benefit manager (PBMs), group purchasing organizations (GPOs) and health maintenance organizations
(HMOs). In addition, the 2005 period reflects a $3.5 million reduction in sales for losses
expected to be incurred on product returns resulting from the AVINZA price increase, effective
April 1, 2005.
Any changes to our estimates for Medicaid prescription activity or prescriptions written under
our managed care contracts may have an impact on our rebate liability and a corresponding impact on
AVINZA net product sales. For example, a 20% variance to our estimated Medicaid and managed care
contract rebate accruals for AVINZA as of March 31, 2006 could result in adjustments to our
Medicaid and managed care contract rebate accruals and net product sales of approximately $0.5
million and $0.8 million, respectively.
ONTAK
Sales of ONTAK were $9.2 million for the three months ended March 31, 2006 compared to $8.0
million for the same 2005 period. ONTAK sales for the 2006 period were positively impacted by a 7%
price increase effective
January 1, 2005 and the impact of a 4% price increase effective July 1, 2005. Under the
sell-through revenue recognition method, price increases do not impact net product sales until the
product sells through the distribution channel; therefore the January 2005 increase had no effect
on net product sales recognized for the three months ended March 31, 2005.
ONTAK revenues for the 2006 period compared to the prior year period were negatively impacted
by a 6% decrease in wholesaler out-movement due primarily to a decline in the office segment of the
market, which was impacted by negative changes in the Centers for Medicare and Medicaid Services
reimbursement rates. Wholesaler out-movement increased, however, by 10% in the first quarter of
2006 compared to the fourth quarter of 2005 due to an improvement in the hospital segment of the
market. We continue to study and evaluate changes to the Centers for Medicare and Medicaid
Services reimbursement rates and expect more favorable reimbursement rates in 2006 compared to
2005.
Targretin capsules
Sales of Targretin capsules were $5.0 million for the three months ended March 31, 2006
compared to $4.0 million for the same 2005 period. This increase reflects the effect of a 7% price
increase effective January 1, 2005 and a 5% price increase effective July 1, 2005. Under the
sell-through revenue recognition method, price increases do not impact net product sales until the
product sells-through the distribution channel; therefore the January 2005 increase had no impact
on net sales for the three months ended March 31, 2005. Targretin capsules sales for the three
months ended March 31, 2006 also benefited from a 49% increase in unit sales in Europe compared to
the prior year period.
In June 2004, the Centers for Medicare and Medicaid Services (CMS) announced formal
implementation of the Section 641 Demonstration Program under the Medicare Modernization Act of
2003 including reimbursement under Medicare for Targretin for patients with T-cell lymphoma (CTCL).
As a result, we continue to expect improved patient access for Targretin in 2006.
Collaborative Research and Development and Other Revenue
Collaborative research and development and other revenues for the three months ended March 31,
2006 were $3.0 million compared to $1.9 million for the same 2005 period. 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 Staff Accounting Bulletin (SAB) No. 101
29
Revenue Recognition, as amended by SAB
104. Revenue from distribution agreements includes recognition of up-front fees collected upon
contract signing and deferred over the life of the distribution arrangement and milestones achieved
under such agreements.
A comparison of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2006 |
|
|
2005 |
|
Collaborative research and development |
|
$ |
894 |
|
|
$ |
862 |
|
Development milestones and other |
|
|
2,078 |
|
|
|
1,078 |
|
|
|
|
|
|
|
|
|
|
$ |
2,972 |
|
|
$ |
1,940 |
|
|
|
|
|
|
|
|
Development milestones and other. Development milestones for the 2006 period reflect a
milestone of $2.0 million earned from GlaxoSmithKline in connection with the commencement of Phase
III studies of eltrombopag. This compares to a $1.0 milestone earned from GlaxoSmithKline in the
2005 period in connection with the commencement of Phase II studies of eltrombopag.
Gross Margin
Gross margin on product sales was 79.7% for the three months ended March 31, 2006 compared to
68.4% for the same 2005 period. Gross margin for the three months ended March 31, 2006 compared to
the same 2005 period was positively impacted by a 7% AVINZA price increase effective April 1, 2005;
a 7% price increase for our oncology products effective January 1, 2005; and a 4% and 5% price
increase for ONTAK and Targretin, respectively, effective July 1, 2005. Under the sell-through
revenue recognition method, changes to prices do not impact net product sales and therefore gross
margins until the product sells through the distribution channel. Accordingly, the price increases
did not have an effect on the margins for the three months ended March 31, 2005.
The increase in the gross margin percentage for the three months ended March 31, 2006 also
reflects lower Medicaid rebates of approximately $2.5 million partially offset by an increase in
managed care rebates of approximately $1.4 million, under contracts with PBMs, GPOs, and HMOs. In
addition, the 2005 period reflects a $3.5 million reduction in sales for losses expected to be
incurred on product returns resulting from the AVINZA price increase, effective April 1, 2005.
The margin for the three months ended March 31, 2006 compared to the prior year period also
benefited from the increase in sales of AVINZA. AVINZA represented 67.7% of net product sales for
the three months ended 2006 compared to 62.8% for the same 2005 period. For both AVINZA
and ONTAK, we have capitalized license, royalty and technology rights recorded in connection
with the acquisition of the rights to those products and accordingly, margins improve as sales of
these products increase and there is greater coverage of the fixed amortization of the intangible
assets. AVINZA cost of product sold includes the amortization of license and royalty rights
capitalized in connection with the restructuring of our AVINZA license and supply agreement in
November 2002. The total amount of AVINZA capitalized license and royalty rights, $114.4 million,
is being amortized to cost of product sold on a straight-line basis over 15 years. The total
amount of ONTAK acquired technology, $45.3 million, is also amortized to cost of product sold on a
straight-line basis over 15 years. ONTAK margins were also positively impacted during the three
months ended March 31, 2006 by lower royalty expense as a result of the restructuring of the
Companys royalty obligation to Lilly. Although there was no royalty owed to Lilly for the three
months ended March 31, 2005, cost of sales for that period reflects the recognition of deferred
royalty expense of approximately $1.5 million, for royalties previously paid to Lilly. Under the
sell-through revenue recognition method, royalties paid based on shipments to wholesalers are
deferred and recognized as the related product sales are recognized. The amount paid to
restructure the ONTAK royalty ($33.0 million) is being amortized through 2014, the remaining life
of the underlying patent, using the greater of the straight-line method or the expense determined
based on the tiered royalty schedule set forth in the restructuring agreement.
In accordance with SFAS 142, Goodwill and Other Intangibles (SFAS 142), for both AVINZA
and ONTAK, capitalized license and technology rights are amortized on a straight-line basis since
the pattern in which
30
the economic benefits of the assets are consumed (or otherwise used up) cannot
be reliably determined. At March 31, 2006, acquired technology, products rights and royalty
buy-down, net totaled $143.3 million.
Overall, given the fixed level of amortization of the capitalized license, royalty and
technology rights, we expect the overall gross margin percentage to increase as sales of AVINZA and
ONTAK increase.
Research and Development Expenses
Research and development expenses were $12.2 million for the three months ended March 31, 2006
compared to $14.7 million for the same 2005 period. The major components of research and
development expenses are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2006 |
|
|
2005 |
|
Research |
|
|
|
|
|
|
|
|
Research performed under collaboration agreements |
|
$ |
924 |
|
|
$ |
982 |
|
Internal research programs |
|
|
4,735 |
|
|
|
4,977 |
|
|
|
|
|
|
|
|
Total research |
|
|
5,659 |
|
|
|
5,959 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development |
|
|
|
|
|
|
|
|
New product development |
|
|
4,231 |
|
|
|
6,096 |
|
Existing product support (1) |
|
|
2,328 |
|
|
|
2,680 |
|
|
|
|
|
|
|
|
Total development |
|
|
6,559 |
|
|
|
8,776 |
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
12,218 |
|
|
$ |
14,735 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes costs incurred to comply with post-marketing regulatory commitments. |
Spending for research expenses was $5.7 million for the three months ended March 31, 2006
compared to $6.0 million for the same 2005 period. The decrease in internal research program
expenses for the three months ended March 31, 2006 compared to the same 2005 period reflects
decreased research expenses across several research programs.
Spending for development expenses decreased to $6.6 million for the three months ended March
31, 2006 compared to $8.8 million for the same 2005 period reflecting a lower level of expense for
both new product development and existing product support. The decrease in expenses for new
product development is due primarily to a reduced level of spending on Phase III clinical trials
for Targretin capsules in NSCLC. In March 2005, we announced that the final data analysis for
Targretin capsules in NSCLC showed that the trials did not meet their endpoints of improved overall
survival and projected two-year survival. A retrospective analysis of the data showed that a
subset (36%) of patients receiving Targretin that developed high triglycerideimia had significantly
better survival. We are continuing to analyze the data and apply it to the continued development
of Targretin in NSCLC. This decrease was partially offset by an increase in thrombopoietin (TPO)
expenses as our lead drug candidate in that area was moved to IND track. The decrease in existing
product support in 2006 compared to 2005 is primarily due to lower expenses for Targretin capsules
and ONTAK post-marketing regulatory studies.
31
A summary of our significant internal research and development programs is as follows:
|
|
|
|
|
Program |
|
Disease/Indication |
|
Development Phase |
AVINZA
|
|
Chronic, moderate-to-severe pain
|
|
Marketed in U.S. |
|
|
|
|
Phase IV |
|
|
|
|
|
ONTAK
|
|
CTCL
|
|
Marketed in U.S., Phase IV |
|
|
Chronic lymphocytic leukemia
|
|
Phase II |
|
|
Peripheral T-cell lymphoma
|
|
Phase II |
|
|
B-cell Non-Hodgkins lymphoma
|
|
Phase II |
|
|
NSCLC third line
|
|
Phase II |
|
|
|
|
|
Targretin capsules
|
|
CTCL
|
|
Marketed in U.S. and Europe |
|
|
NSCLC first-line
|
|
Phase III |
|
|
NSCLC monotherapy
|
|
Planned Phase II/III |
|
|
NSCLC second/third line
|
|
Planned Phase II/III |
|
|
Advanced breast cancer
|
|
Phase II |
|
|
Renal cell cancer
|
|
Phase II |
|
|
|
|
|
Targretin gel
|
|
CTCL
|
|
Marketed in U.S. |
|
|
Hand dermatitis (eczema)
|
|
Planned Phase II/III |
|
|
Psoriasis
|
|
Phase II |
|
|
|
|
|
LGD4665 (Thrombopoietin oral mimic)
|
|
Idiopathic Thrombocytopenia (TCP), other
TCPs
|
|
IND Track |
|
|
|
|
|
LGD5552 (Glucocorticoid agonists)
|
|
Inflammation, cancer
|
|
IND Track |
|
|
|
|
|
Selective androgen receptor modulators,
e.g., LGD3303 (agonist/antagonist)
|
|
Male hypogonadism, female & male
osteoporosis, male & female sexual
dysfunction, frailty. Prostate cancer,
hirsutism, acne, androgenetic alopecia.
|
|
Pre-clinical |
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 Risk Factors below for additional discussion of the uncertainties
surrounding our research and development initiatives.
Selling, General and Administrative Expense
Selling, general and administrative expense was $22.2 million for the three months ended March
31, 2006 compared to $19.2 million for the same 2005 period. The increase for the three months
ended March 31, 2006 is due to higher audit and consultant fees in connection with the completion
of the Companys assessment of internal controls as of December 31, 2005 under the Sarbanes-Oxley
Act. A significant portion of the Companys 2005 assessment of internal controls was performed in
2006 due to the fact that the restatement of our financial statements was not completed until late
2005. General and administrative expenses were also higher for the three months ended March 31,
2006, due to legal costs incurred in connection with the ongoing SEC investigation, shareholder
litigation and our strategic alternatives process. In addition, AVINZA advertising and promotion
expenses increased in the three months ended March 31, 2006 compared to the prior year period when
Ligand and Organon shared equally all AVINZA promotion expenses. As part of the AVINZA termination
and return of
rights agreement entered into in January 2006, discussed under Overview above, we are now
responsible for all AVINZA advertising and
32
promotion expenses. This increase was partially offset
by lower selling and marketing expenses due to the reduction in our AVINZA primary care sales force
as discussed under Recent Developments above and lower advertising and promotion expenses for our
Oncology products compared to the prior year period.
We expect selling, general and administrative expenses to continue to be higher in 2006
compared to the prior year due to the ongoing cost of compliance with the Sarbanes-Oxley Act, legal
expenses in connection with the SEC investigation, stockholder litigation, and strategic
alternatives process and the expected expenses to be recognized in connection with the employee
retention agreements discussed under Recent Developments above. These increases are expected to
be partially offset by lower sales force expenses as a result of the reduction in our AVINZA
primary care sales force.
Co-promotion Expense
Co-promotion expense due Organon amounted to $11.0 million for the three months ended March
31, 2006 compared to $7.7 million for the same 2005 period. As discussed under Overview above,
in connection with the AVINZA termination and return of co-promote rights agreement with Organon,
we agreed to pay Organon 23% of net AVINZA product sales through September 30, 2006 as compensation
for promotion of the product during the Transition Period. This compares to co-promote expense in
the prior year period which was based on 30% of net sales, as per the original co-promotion
agreement, determined using the sell-in method of revenue recognition. As sell-in revenues for the
three months ended March 31, 2005 were higher than sell-through revenues, co-promotion expense as a
percentage of reported AVINZA net sales was higher than the contracted rate.
Co-promotion expense for the three months ended March 31, 2006 also includes $3.3 million
which represents the pro-rata share of a $10.0 million payment we agreed to make to Organon in
January 2007, provided that Organon has made its required level of sales calls during the
Transition Period. This payment represents an approximation of the fair value of the service
element under the agreement during the Transition Period (when the provision to pay 23% of AVINZA
net sales is also considered) and, therefore, is recognized as an additional component of
co-promotion expense ratably over the Transition Period.
Co-promote Termination Charges
As discussed above under Overview, we entered into a termination and return of AVINZA rights
agreement with Organon in January 2006. Co-promote termination charges represent the cost
associated with the termination agreement totaling $132.9 million, and is comprised of a $37.75
million payment we agreed to make to Organon in October 2006 and the fair value of subsequent
quarterly payments, estimated at approximately $95.2 million as of January 1, 2006, that we will
make to Organon based on net product sales of AVINZA, through November 2017. The co-promote
termination liability as of March 31, 2006 also includes approximately $3.3 million of accretion
expense to reflect the net present value of the liability as of that date which is included in
interest expense.
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, capital and operating lease transactions, accounts receivable factoring and equipment
financing arrangements, and investment income.
Working capital was a deficit of $143.7 million at March 31, 2006 compared to a deficit of
$102.2 million at December 31, 2005. Cash, cash equivalents, short-term investments and restricted
investments totaled $69.5 million at March 31, 2006 compared to $88.8 million at December 31, 2005.
We primarily invest our cash in United States government and investment grade corporate debt
securities. Restricted investments consist of certificates of deposit held with a financial
institution as collateral under equipment financing and third-party service provider arrangements.
33
Operating Activities
Operating activities used cash of $20.0 million for the three months ended March 31, 2006
compared to $2.6 million for the same 2005 period. The higher use of cash for the 2006 period
reflects the changes in operating assets and liabilities, primarily due to decreases in accounts
payable and accrued liabilities of $14.9 million and deferred revenues net of $6.6 million,
partially offset by decreases in inventories, net of $1.5 million and accounts receivable, net of
$0.9 million. As further discussed below, the reconciliation of net loss to net cash used in
operating activities for the three months ended March 31, 2006 compared to the prior year period
also reflects the accrual of the AVINZA co-promote termination liability due Organon of $136.2
million in connection with the termination and return of rights agreement entered into in January
2006. For the same 2005 period, use of operating cash was impacted by the changes in operating
assets and liabilities primarily due to decreases in accounts receivables, net of $12.5 million
partially offset by an increase in inventories, net of $1.1 million and a decrease in accounts
payable and accrued liabilities of $1.0 million.
In connection with the termination of the co-promotion agreement, we will pay Organon $37.75
million on or before October 15, 2006 and $10.0 million on or before January 15, 2007, provided
that Organon has made its minimum required level of sales calls. Additionally, we agreed to pay
Organon 23% of AVINZA net sales for co-promotion activities through September 30, 2006 (the
Transition Period), and 6.5% of AVINZA net sales through December 31, 2012 and thereafter, 6.0% of
AVINZA net sales through November 2017 (patent expiration).
Investing Activities
Investing activities provided cash of $3.0 million for the three months ended March 31, 2006
compared to the use of cash of $39.6 million for the same 2005 period. Cash provided for the three
months ended March 31, 2006 primarily reflects proceeds of $3.2 million for the sales of short-term
investments net of purchases of short-term investments. The use of cash for the three months ended
March 31, 2005 reflects a $20.0 payment for the buy-down of ONTAK royalty payments in connection
with the amended royalty agreement entered into in November 2004 between the Company and Lilly,
$18.5 million of net purchases of short-term investments, and a $0.6 million capitalized payment to
The Salk Institute for the exercise of an option to buy out royalty payments due on future sales of
lasofoxifene for a second indication.
Financing Activities
Financing activities provided cash of $0.04 million for the three months ended March 31, 2006
compared to $0.8 million for the same 2005 period. Cash provided by financing activities for the
three months ended March 31, 2006 includes proceeds from the exercise of employee stock options of
$0.5 million and net payments under equipment financing arrangements of $0.3 million. Cash
provided by financing activities for the three months ended March 31, 2005 includes proceeds from
the exercise of employee stock options and purchases under the Companys employee stock purchase
plan and net proceeds from equipment financing arrangements of $0.8 million and $0.2 million,
respectively.
Certain of our property and equipment is pledged as collateral under various equipment
financing arrangements. As of March 31, 2006, $5.5 million was outstanding under such arrangements
with $2.3 million classified as current. Our equipment financing arrangements have terms of three
to four years with interest ranging from 4.73% to 9.64%.
We believe our available cash, cash equivalents, short-term investments and existing sources
of funding will be sufficient to satisfy our anticipated operating and capital requirements through
at least the next 12 months. Our future operating and capital requirements will depend on many
factors, including: the effectiveness of our commercial activities during the transition period of
our AVINZA co-promotion agreement with Organon, which will conclude on September 30, 2006, 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 efforts of our
collaborators; and
the cost of production. We will also consider additional equipment financing arrangements similar
to arrangements currently in place.
34
Leases and Off-Balance Sheet Arrangements
We lease certain of our office and research facilities under operating lease arrangements with
varying terms through July 2015. 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%.
As of March 31, 2006, we are not involved in any off-balance sheet arrangements.
Contractual Obligations
As of March 31, 2006, future minimum payments due under our contractual obligations are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
|
|
|
|
Less than 1 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
year |
|
|
1-3 years |
|
|
3-5 years |
|
|
After 5 years |
|
Capital lease obligations (1) |
|
$ |
6,186 |
|
|
$ |
2,663 |
|
|
$ |
3,310 |
|
|
$ |
213 |
|
|
$ |
¾ |
|
Operating lease obligations |
|
|
20,207 |
|
|
|
2,889 |
|
|
|
3,804 |
|
|
|
3,833 |
|
|
|
9,681 |
|
Loan payable to bank (2) |
|
|
13,702 |
|
|
|
1,191 |
|
|
|
12,511 |
|
|
|
¾ |
|
|
|
¾ |
|
6% Convertible Subordinated
Notes (3) |
|
|
141,979 |
|
|
|
7,749 |
|
|
|
134,230 |
|
|
|
¾ |
|
|
|
¾ |
|
Organon
termination liability(4)(5) |
|
|
276,069 |
|
|
|
43,252 |
|
|
|
27,039 |
|
|
|
37,600 |
|
|
|
168,178 |
|
Other liabilities (6) |
|
|
617 |
|
|
|
104 |
|
|
|
211 |
|
|
|
211 |
|
|
|
91 |
|
Retention bonus obligation |
|
|
2,430 |
|
|
|
2,430 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
Distribution service agreements |
|
|
2,882 |
|
|
|
2,882 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
Consulting agreements |
|
|
1,597 |
|
|
|
1,597 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
Manufacturing agreements |
|
|
9,235 |
|
|
|
9,235 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
474,904 |
|
|
$ |
73,992 |
|
|
$ |
181,105 |
|
|
$ |
41,857 |
|
|
$ |
177,950 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes interest payments as follows |
|
$ |
636 |
|
|
$ |
366 |
|
|
$ |
264 |
|
|
$ |
6 |
|
|
$ |
¾ |
|
(2) Includes interest payments as follows |
|
|
1,950 |
|
|
|
841 |
|
|
|
1,109 |
|
|
|
¾ |
|
|
|
¾ |
|
(3) Includes interest payments as follows |
|
|
12,829 |
|
|
|
7,749 |
|
|
|
5,080 |
|
|
|
¾ |
|
|
|
¾ |
|
(4) Includes accretion of interest as
follows |
|
|
139,827 |
|
|
|
719 |
|
|
|
7,331 |
|
|
|
16,569 |
|
|
|
115,208 |
|
(5) Includes $37,750 payment due Organon on or
before October 15, 2006. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6) Includes a liability under a royalty financing agreement. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of March 31, 2006, 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 $18.2 million. In the next 12 months, we also plan to spend
approximately $3.2 million on capital expenditures.
In January 2006, we signed an agreement with Organon that terminated the AVINZA co-promotion
agreement between the two companies and returned AVINZA co-promotion rights to Ligand. In
connection with this agreement, we will pay Organon $37.75 million on or before October 15, 2006
and $10.0 million on or before January 15, 2007, provided that Organon has made its minimum
required level of sales calls. After termination, we will 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 2017.
As of March 1, 2006, we entered into letter agreements with approximately 67 of our key
employees, including a number of our executive officers. These letter agreements provide 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. The Compensation Committee of the Board of Directors has
approved the Companys entry into these Agreements. The retention or stay bonus payments generally
vest at the end of 2006 and total payments to employees of approximately $2.7 million would be made
in January 2007 if all participants qualify for the payments. In accordance with the Statement of
Financial Accounting Standard (SFAS) 146, Accounting for Costs Associated
35
with Exit or Disposal
Activities, the cost of the plan is ratably accrued over the term of the agreements, which is
approximately 10 months. For the three months ended March 31, 2006, the Company recognized
approximately $0.3 million of expense under the plan. As an additional retention incentive,
certain employees were also granted stock options totaling approximately 122,000 shares at an
exercise price of $11.90 per share.
In May 2006, Ligand and Cardinal Health PTS, LLC (Cardinal) 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.
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 quarter ended March 31, 2006
to the critical accounting policies reported in the Managements Discussion and Analysis section of
our 2005 Annual Report are related to 1) our accounting for the termination and return of the
AVINZA co-promotion rights entered into with Organon in January 2006 and 2) our accounting for
stock-based compensation.
Co-Promote Termination Accounting
As part of the agreement, we will unconditionally pay Organon $37.75 million on or before
October 15, 2006, and after the termination, we will make quarterly payments to Organon equal to
6.5% of AVINZA net sales through December 31, 2012 and thereafter 6% through patent expiration,
currently anticipated to be November of 2017. The unconditional payment of $37.75 million to
Organon and the estimated fair value of the amounts to be paid to Organon after the termination
($98.5 million as of March 31, 2006), based on the 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.
Although the quarterly payments to Organon will be based on net reported AVINZA product sales,
such payments will not result in current period expense in the period upon which the payment is
based, but instead will be charged against the co-promote termination liability. Any changes to our
estimates of future net AVINZA product sales, however, will result in a change to the liability
which will be recognized as an increase or decrease to earnings in the period such changes are
identified. Additionally, we recognize the accretion of interest expense each period to reflect
the current net present value of the termination liability. 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 our co-promote
termination liability, may be materially different from our current estimates. In addition,
because of the inherent difficulties of predicting possible changes to the estimates and
assumptions used to determine the estimate of future AVINZA product sales, we are unable to
quantify an estimate of the reasonably likely effect of any such changes on our results of
operations or financial position.
Stock-Based Compensation
Effective January 1, 2006, our accounting policy related to stock option accounting changed
upon our adoption of Statement of Financial Accounting Standards (SFAS) No. 123(R), Share-Based
Payment. SFAS 123(R) requires us to expense the fair value of employee stock options and other
forms of stock-based compensation. Under the fair value recognition provisions of SFAS 123(R),
stock-based compensation cost is estimated at the grant date based on the value of the award and is
recognized as expense ratably over the service period of the award. Determining the appropriate
fair value model and calculating the fair value of stock-based awards requires judgment, including
estimating stock price volatility, the risk-free interest rate, forfeiture rates and the expected
life of the
36
equity instrument. Expected volatility utilized in the model is based on the
historical volatility of the Companys stock price and other factors. The risk-free interest rate
is derived from the U.S. Treasury yield in effect at the time of the grant. The model incorporates
forfeiture assumptions based on an analysis of historical data. The expected life of the 2006
grants is derived in accordance with the safe harbor expected term assumptions under Staff
Accounting Bulletin No. 107. For the three-months ended March 31, 2006, we recorded $0.6 million
of stock-based compensation for awards granted to employees and non-employee directors.
Prior to January 1, 2006, we accounted for options granted to employees in accordance with
Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees, and related
interpretations and followed the disclosure requirements of SFAS No. 123, Accounting for
Stock-Based Compensation. Therefore, prior to the first quarter of 2006, we did not record any
compensation cost related to stock-based awards, 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 grant.
Periods prior to our first quarter of 2006 were not restated to reflect the fair value method of
expensing stock options. The impact of expensing stock awards on our earnings may be significant
and is further described in Note 1 to the notes to the unaudited condensed consolidated financial
statements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
At March 31, 2006, our investment portfolio included fixed-income securities of $16.8 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 would have no material impact on our financial condition, results of operations
or cash flows. At March 31, 2006, 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.
37
ITEM 4. CONTROLS AND PROCEDURES
a) Evaluation of disclosure controls and procedures.
The Company is required to maintain disclosure controls and procedures that are designed to
ensure that information required to be disclosed in its reports under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SECs rules and forms,
and that such information is accumulated and communicated to management, including the Companys
Chief Executive Officer (CEO) and Chief Financial Officer (CFO) as appropriate, to allow timely
decisions regarding required disclosure.
In connection with the preparation of the Form 10-Q for the period ended March 31, 2006,
management, under the supervision of the CEO and CFO, conducted an evaluation of disclosure
controls and procedures. Based on that evaluation, the CEO and CFO concluded that the Companys
disclosure controls and procedures were not effective as of March 31, 2006 due to the material
weaknesses described in the Companys management report on internal control over financial
reporting included in Item 9A to its Annual Report on Form 10-K for the year ended December 31,
2005, as filed on March 31, 2006 and described below. As of March 31, 2006, the material
weaknesses identified in the 2005 Form 10-K have not been fully remediated. Additionally, since
the material weaknesses described below have not been fully remediated, the CEO and CFO conclude
that the Companys disclosure controls and procedures are not effective at a reasonable assurance
level as of the end of the fiscal quarter and as of the filing date of the Form 10-Q.
As of March 31, 2006, management identified the continued existence of the following material
weaknesses, which were identified in our 2005 Annual Report, in connection with its assessment of
the effectiveness of the Companys internal control over financial reporting:
|
|
|
Revenue Recognition The Company did not have effective controls and procedures to
ensure that revenues were recognized in accordance with generally accepted accounting
principles. As further discussed below, the Company has implemented new revenue
recognition models and related internal controls to remediate this weakness. Such
remediation efforts, however, were not fully implemented until the fourth quarter of
2005. While management believes the controls with respect to revenue recognition were
appropriately designed and effective at March 31, 2006, the timing of the
implementation of the remediation efforts and the Companys program to test, assess,
and conclude as to the effectiveness of such remediation efforts resulted in
limitations on managements ability to conclude that such controls were operating
effectively for a reasonable period of time prior to March 31, 2006. |
|
|
|
|
Record Keeping and Documentation - The Company did not have adequate record keeping
and documentation supporting the decisions made and the accounting for complex
transactions. As further discussed below, the Company has implemented new procedures
and controls to remediate this weakness. Such remediation efforts, however, were not
fully implemented until the fourth quarter of 2005. While management believes the
controls with respect to record keeping and documentation were appropriately designed
and effective at March 31, 2006, the timing of the implementation of the remediation
efforts and the Companys program to test, assess, and conclude as to the effectiveness
of such remediation efforts resulted in limitations on managements ability to conclude
that such controls were operating effectively for a reasonable period of time prior to
March 31, 2006. |
|
|
|
|
Lack of Sufficient Qualified Accounting Personnel - The Company did not have
adequate manpower in its accounting and finance department and lacked sufficient
qualified accounting personnel to identify and resolve complex accounting issues in
accordance with generally accepted accounting principles. As further discussed below,
the Company has a plan in place to recruit and hire new accounting personnel. This has
resulted in the hiring of a Director of Accounting and a Director of Internal Audit in
the second quarter of 2006. The Company is still in the process of recruiting for a
Manager of Revenue Recognition. |
|
|
|
|
Financial Statement Close Procedures - The Company did not have adequate financial
reporting and close procedures. As further discussed below, the Company has
implemented new procedures and controls to remediate this weakness. Such remediation
efforts, however, were not fully implemented |
38
|
|
|
until the fourth quarter of 2005. While
management believes the controls with respect to the financial statement close
procedures were appropriately designed and effective at March 31, 2006, the timing of
the implementation of the remediation efforts and the Companys program to test,
assess, and conclude as to the effectiveness of such remediation efforts resulted in
limitations on managements ability to conclude that such controls were operating
effectively for a reasonable period of time prior to March 31, 2006. |
|
|
|
|
Internal Audit. The Company did not maintain an independent effective Internal Audit
Department. This material weakness resulted from: 1) the Internal Audit Department was
redirected during the second, third and fourth quarters of 2005 to assist with the
restatement of the Companys consolidated financial statements; and 2) the resignation
of the Director of Internal Audit on December 2, 2005. As a result, the Companys
Internal Audit Department executed only a small portion of the activities contemplated
to be performed pursuant to the 2005 internal audit plan. In late December 2005, the
Company engaged a nationally recognized external consulting firm to perform the
activities of the Internal Audit Department, including the Companys compliance efforts
with respect to Section 404 of the Sarbanes Oxley Act of 2002. Additionally, during
the second quarter of 2006, the Company hired a replacement Director of Internal Audit
who is expected to commence employment in the second quarter of 2006. |
|
|
|
|
Spreadsheet Controls. In connection with the change in the Companys revenue
recognition for product sales from the sell-in method to the sell-through method, the
use of spreadsheets has become a pervasive and integral part of the Companys financial
accounting, quarter-end close, and financial reporting processes. However, due to the
time limitations on the testing of the spreadsheets relating to revenue recognition as
well as the fact that the Company did not have documented policies and procedures
regarding spreadsheets relating to financial processes other than revenue recognition,
management determined that a material weakness continues to exist with respect to the
spreadsheets utilized by the Company. Specifically, the Company continued to
experience limitations on its ability to perform detail testing on the spreadsheets
relating to revenue recognition during 2005 and the first quarter of 2006 since the
quarterly controls over such spreadsheets were not fully implemented until the fourth
quarter of 2005. Additionally, the Company did not have effective end user general
controls over the access, change management and validation of spreadsheets used in its
financial processes, other than revenue recognition, nor did the Company have formal
policies and procedures in place relating to the use of spreadsheets. Accordingly, the
Company determined, with respect to such spreadsheets, that there was no change
management or access controls in place to prevent an unauthorized modification of the
formulas within these spreadsheets and limited management review or approval to detect
unauthorized changes or errors. Considering the significant reliance on spreadsheets
in the current period the continuing deficiencies discussed above surrounding the use
of spreadsheets have been assessed to be a material weakness as of March 31, 2006. |
|
|
|
|
Segregation of Duties. Management has identified certain members of the Companys
accounting and finance department who have accounting system access rights that are
incompatible with the current roles and duties of such individuals. This control
deficiency was identified as of December 31, 2004. However, when considered in
conjunction with the material weaknesses surrounding internal audit and monitoring
controls discussed herein, this control deficiency was elevated to a material weakness
as of December 31, 2005 and continued to exist as a material weakness as of March 31,
2006. |
|
|
|
|
Monitoring Controls. As a result of the demands placed on the Companys accounting
and finance department with respect to the Companys recent accounting restatement,
management did not properly maintain the Companys documentation of internal control
over financial reporting during
2005 to reflect changes in internal control over financial reporting and as a result did
not substantively commence the process to update such documentation and complete its
assessment until December 2005. Further, the restatement process which occurred in 2005
resulted in the delayed performance of certain control procedures in the period-end
close process. Accordingly, management determined that |
39
|
|
|
this control deficiency
constituted a material weakness as of December 31, 2005 and continued to exist as a
material weakness as of March 31, 2006. |
b) Remediation Steps to Address Material Weaknesses
|
|
|
During 2005, the Companys finance and accounting department, with the assistance of
outside expert consultants, developed accounting models to recognize sales of its
domestic products, except Panretin, under the sell-through revenue recognition method
in accordance with generally accepted accounting principles. In connection with the
development of these models, the Company also implemented a number of new and enhanced
controls and procedures to support the sell-through revenue recognition accounting
models. These controls and procedures include approximately 35 revenue models used in
connection with the sell-through revenue recognition method including related
contra-revenue models and demand reconciliations to support and assess the
reasonableness of the data and estimates, which includes information and estimates
obtained from third-parties. |
|
|
|
|
During the fourth quarter of 2005, the accounting and finance department completed
the implementation of procedures surrounding the month-end close process to ensure that
the information and estimates necessary for reporting product revenues under the
sell-through method to facilitate a timely period-end close were available. |
|
|
|
|
A training program for employees and consultants involved in the revenue recognition
accounting was developed and took place during the fourth quarter of 2005. In 2006,
additional training will be provided on a regular and periodic basis and updated as
considered necessary. |
|
|
|
|
The Company intends to hire an expert manager on revenue recognition who will be
responsible for managing all aspects of the Companys revenue recognition accounting,
sell-through revenue recognition models and supporting controls and procedures. The
Company expects that this position will be filled during the third quarter of 2006 or
as soon as possible thereafter. However, until this position is filled, the Company
continues to use outside expert consultants to fulfill this function. |
|
|
|
|
The Companys commercial operations department is additionally implementing a number
of improvements that will further enhance the controls surrounding the recognition of
product revenue. These include the development of an information operations system
that will provide management with a greater amount of reliable, timely data including
changes related to product movement, demand and inventory levels. The department is
also adding additional personnel to review, analyze and report this information. |
|
|
|
|
Certain of the remediation efforts described above relating to the new revenue
recognition models and related controls were not implemented until the fourth quarter
of 2005. While management believes that such controls were appropriately designed and
effective at March 31, 2006, the timing of the remediation efforts precluded the
Companys ability to test, assess, and conclude as to the effectiveness of
implementation of such remediated internal controls. This resulted in limitations on
managements ability to conclude that such controls were operating effectively for a
reasonable period of time prior to March 31, 2006. Additionally, certain of the other
remediation efforts (for example, the hiring of a Manager of Revenue Recognition) have
not been completed. |
|
|
|
Record Keeping and Documentation |
|
|
|
The Company has implemented improved procedures for analyzing, reviewing, and
documenting the support for significant and complex transactions. Documentation for
all complex transactions is now maintained by the Corporate Controller. |
40
|
|
|
The Companys accounting and finance and legal departments developed a formal
internal policy during the fourth quarter of 2005 entitled Documentation of Accounting
Decisions, regarding the preparation and maintenance of contemporaneous documentation
supporting accounting transactions and contractual interpretations. The formal policy
provides for enhanced communication between the Companys finance and legal personnel. |
|
|
|
|
The remediation efforts described above were not implemented until the fourth
quarter of 2005. While management believes the above controls were appropriately
designed and implemented at March 31, 2006, the timing of the implementaiton of the
remediation efforts precluded the Companys ability to test, assess, and conclude as to
the effectiveness of such remediated internal controls resulted in limitations on
managements ability to conclude that such controls were operating effectively for a
reasonable period of time prior to March 31, 2006. |
|
|
|
Lack of Sufficient Qualified Accounting Personnel |
|
|
|
As discussed above, the Companys Director of Internal Audit resigned effective
December 2, 2005. In December 2005, the Company retained a nationally recognized
external consulting firm to assist the Internal Audit Department and oversee the
Companys ongoing compliance effort under Section 404 of the Sarbanes Oxley Act of 2002
until a permanent replacement for the Companys Director of Internal Audit is hired.
During the second quarter of 2006, the Company hired a replacement Director of Internal
Audit who is expected to commence employment in May 2006. |
|
|
|
|
During 2005, the Company engaged expert accounting consultants to assist the
Companys accounting and finance department with a number of activities, including the
management and implementation of controls surrounding the Companys new sell-through
revenue recognition models, the administration of existing controls and procedures,
preparation of the Companys SEC filings and the documentation of complex accounting
transactions. |
|
|
|
|
During the second quarter of 2006, the Company hired a Director of Accounting, who
is a certified public accountant. |
|
|
|
|
The Company expects to hire additional senior accounting personnel who are certified
public accountants including, as discussed above, a Director of Internal Audit and a
Manager of Revenue Recognition. The Manager of Revenue Recognition is targeted to be
filled as soon as possible during the 2006 fiscal year. Until all such positions are
filled, the Company will continue to use outside expert accounting consultants to
fulfill such functions. |
|
|
|
|
The Company continues to consider alternatives for organizational or responsibility
changes which it believes may be necessary to attract additional senior accounting
personnel who are certified public accountants or have recent public accounting
experience. |
|
|
|
|
Although the remediation activities identified above were initiated during 2005, the
Company is still in the process of recruiting for the Manager of Revenue Recognition.
Additionally, the Director of Accounting was not hired and in place until the beginning
of the Companys second quarter in 2006. Therefore, as of March 31, 2006, the Company
continued to have a lack of sufficient qualified accounting personnel. |
|
|
|
Financial Statement Close Procedures |
|
|
|
The Company has designed and implemented process improvements concerning the
Companys financial reporting and close procedures. A training session for all finance
department employees and consultants involved in the financial statement close process
took place during the fourth quarter of 2005. Additionally, an ongoing periodic
training update/program has been implemented to conduct training sessions on a regular
quarterly basis to provide training to its finance and accounting personnel |
41
|
|
|
and to
review procedures for timely and accurate preparation and management review of
documentation and schedules to support the Companys financial reporting and period-end
close process. As discussed above, the additional management personnel to be hired by
the finance department will also help ensure that all documentation necessary for the
financial reporting and period-end close procedures is properly prepared and reviewed. |
|
|
|
|
The remediation efforts described above were not implemented until the fourth
quarter of 2005, which precluded managements ability to test, assess, and conclude as
to the effectiveness of such remediated internal controls for a reasonable period of
time prior to March 31, 2006. |
|
|
|
As discussed under the caption Lack of Sufficient Qualified Accounting Personnel
above, the Company hired a Director of Internal Audit, who is expected to commence
employment in the second quarter of 2006. Until the Director of Internal Audit has
commenced employment, the Company has engaged a nationally recognized external
consulting firm to perform the functions of the Internal Audit Department. |
|
|
|
Revenue Spreadsheets Controls. The Company has implemented new revenue recognition
models and related internal controls to remediate this weakness. Such remediation
efforts, however, were not fully implemented until the fourth quarter of 2005. While
management believes the controls with respect to revenue recognition were appropriately
designed and effective at March 31, 2006, the timing of the implementation of the
remediation efforts and the Companys program to test, assess, and conclude as to the
effectiveness of such remediation efforts resulted in limitations on managements
ability to conclude that such controls were operating effectively for a reasonable
period of time prior to March 31, 2006. |
|
|
|
|
Non-Revenue Spreadsheet Controls. Commencing in the first quarter of 2006 and
continuing thereafter, management identified and categorized significant spreadsheets
using qualitative measures of financial risk and complexity. Once inventoried, the
spreadsheets were subject to standardized control activity testing, ensuring that any
deficiencies in such spreadsheets relating to security, change management, input
validation, documentation, and segregation of duties were addressed. Detail testing
was then performed with respect to significant spreadsheets to ensure the accuracy of
formulas and internal and external references within the spreadsheets. Management is
in the process of implementing policies and procedures relating to spreadsheet
management which are designed to ensure that adequate control activities exist
surrounding significant spreadsheets. These policies and procedures, which will
include controls relating to data integrity, version control, and restricted access to
such spreadsheets, are expected to be implemented in the third quarter of 2006. |
|
|
|
In the first quarter of 2006, management identified those members of the Companys
accounting and finance department who had accounting system access rights that were
incompatible with the current roles and duties of such individuals and subsequently
terminated the access rights for those individuals. On a quarterly basis, commencing
with the first quarter of 2006, management will
monitor the accounting system access rights of those employees with access to the
accounting software systems to identify any grants of incompatible user access rights or
any user access rights resulting from subsequent changes or modifications to the
Companys internal control structure. |
42
|
|
|
As discussed under the caption Internal Audit Plan above, the Company hired a
Director of Internal Audit, who is expected to commence employment in the second
quarter of 2006. Additionally, and until the Director of Internal Audit has commenced
employment, the Company has engaged a nationally recognized external consulting firm to
implement and execute the 2006 Internal Audit Plan starting in the second quarter of
2006. As part of the 2006 Internal Audit Plan, these consultants are responsible for
assisting management with updating and maintaining the Companys documentation of
internal control over financial reporting. The consultants will also assist with the
testing of such internal controls and in monitoring the progress of any ongoing and
newly identified remediation efforts to help ensure the timely completion of the
Companys 2006 monitoring program. |
Independent Registered Public Accountants
BDO Seidman LLP, our independent registered public accountants, have not performed any procedures
to review our remediation efforts.
c) Changes in Internal Control Over Financial Reporting
Except for the changes in connection with the remediation efforts performed in regard to the
material weaknesses described above, there were no changes in the Companys internal control over
financial reporting that occurred during the quarter ended March 31, 2006 that have materially
affected, or are reasonably likely to materially affect, the Companys internal control over
financial reporting.
43
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
The Companys subsidiary, Seragen, Inc. and Ligand, were named parties to Sergio M. Oliver, et
al. v. Boston University, et al., a putative 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 March 31, 2006, 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.
Beginning in August 2004, several purported class action stockholder lawsuits were filed in
the United States District Court for the Southern District of California against the Company and
certain of its directors and officers. The actions were brought on behalf of purchasers of the
Companys common stock during several time periods, the longest of which runs from July 28, 2003
through August 2, 2004. The complaints generally allege that the Company violated Sections 10(b)
and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 of the Securities and Exchange
Commission by making false and misleading statements, or concealing information about the Companys
business, forecasts and financial performance, in particular statements and information related to
drug development issues and AVINZA inventory levels. These lawsuits have been consolidated and
lead plaintiffs appointed. A consolidated complaint was filed by the plaintiffs in March 2005. On
September 27, 2005, the court granted the Companys motion to dismiss the consolidated complaint,
with leave for plaintiffs to file an amended complaint within 30 days. In December 2005, the
plaintiffs filed a second amended complaint again alleging claims under Section 10(b) and 20(a) of
the Securities Exchange Act against the Company, David Robinson and Paul Maier. The amended
complaint asserts an expanded Class Period of March 19, 2001 through May 20, 2005 and includes
allegations arising from the Companys announcement on May 20, 2005 that it would restate certain
financial results. Defendants filed their motion to dismiss plaintiffs second amended complaint
in January 2006. No trial date has been set.
Beginning on or about August 13, 2004, several derivative actions were filed on behalf of the
Company by individual stockholders in the Superior Court of California. The complaints name the
Companys directors and certain of its officers as defendants and name the Company as a nominal
defendant. The complaints are based on the same facts and circumstances as the purported class
actions discussed in the previous paragraph and generally allege breach of fiduciary duties, abuse
of control, waste and mismanagement, insider trading and unjust enrichment. These actions are in
discovery. The court has set a trial date of November 17, 2006.
In October 2005, a shareholder derivative action was filed on behalf of the Company in the
United States
District Court for the Southern District of California. The complaint names the Companys
directors and certain of its officers as defendants and the Company as a nominal defendant. The
action was brought by an individual
44
stockholder. The complaint generally alleges that the
defendants falsified Ligands publicly reported financial results throughout 2002 and 2003 and the
first three quarters of 2004 by improperly recognizing revenue on product sales. The complaint
generally alleges breach of fiduciary duty by all defendants and requests disgorgement, e.g., under
Section 304 of the Sarbanes-Oxley Act of 2002. In January 2006, the defendants filed a motion to
dismiss plaintiffs verified shareholder derivative complaint. Plaintiffs opposition was filed in
February 2006. No trial date has been set.
The Company believes that all of the above actions are without merit and intends to vigorously
defend against each of such lawsuits. Due to the uncertainty of the ultimate outcome of these
matters, the impact on future financial results is not subject to reasonable estimates.
On December 11, 2001, a lawsuit was filed in the United States District Court for the District
of Massachusetts against Ligand by the Trustees of Boston University and other former stakeholders
of Seragen. The suit was subsequently transferred to federal district court in Delaware. The
complaint alleged breach of contract, breach of the implied covenants of good faith and fair
dealing and unfair and deceptive trade practices based on, among other things, allegations that
Ligand wrongfully withheld approximately $2.1 million in consideration due the plaintiffs under the
Seragen acquisition agreement. This amount had been previously accrued for in the Companys
consolidated financial statements in 1998. The complaint sought payment of the withheld
consideration and treble damages. Ligand filed a motion to dismiss the unfair and deceptive trade
practices claim. The Court subsequently granted Ligands motion to dismiss the unfair and
deceptive trade practices claim (i.e., the treble damages claim), in April 2003. In November 2003,
the Court granted Boston Universitys motion for summary judgment, and entered judgment for Boston
University. In January 2004, the district court issued an amended judgment awarding interest of
approximately $0.7 million to the plaintiffs in addition to the approximately $2.1 million
withheld. In January 2006, the appeals court affirmed the district courts ruling against us.
Additional interest on the above amounts of approximately $0.1 million was accrued through January
2006 and was added to the judgment. The withheld amount including the interest was paid in
February 2006.
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.
45
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, 2005. 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.
The restatement of our consolidated financial statements has had a material adverse impact on us,
including increased costs, the increased possibility of legal or administrative proceedings, and
delisting from the NASDAQ National Market.
We determined that our consolidated financial statements for the years ended December 31, 2002
and 2003, and as of and for the quarters of 2003, and for the first three quarters of 2004, as
described in more detail in our 2004 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. |
|
|
We have been named in a number of lawsuits that began in August
2004 and an additional lawsuit filed in October 2005 claiming to
be class actions and shareholder derivative actions. As a result
of our restatement the plaintiffs in these lawsuits may make
additional claims, expand existing claims and/or expand the time
periods covered by the complaints. Other plaintiffs may bring
additional actions with other claims, based on the restatement.
If such events occur, we may incur additional substantial defense
costs regardless of their outcome. Likewise, such events might
cause a diversion of our managements time and attention. If we
do not prevail in any such actions, we could be required to pay
substantial damages or settlement costs. |
|
|
The Securities and Exchange Commission (SEC) has instituted a
formal investigation of the Companys consolidated financial
statements. 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. |
|
|
The need to reconsider our accounting treatment and the
restatement of our consolidated financial statements caused us to
be late in filing our required reports on Form 10-K for December
31, 2004 and Forms 10-Q for the quarters ended March 31, 2005 and
June 30, 2005, respectively, which caused us to be delisted from
NASDAQ National Market in September 2005. See Our common stock
was delisted from the NASDAQ National Market which may reduce the
price of our common stock and the levels of liquidity available to
our stockholders and cause confusion among investors for
additional discussion regarding the NASDAQ delisting. |
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.
Maintaining an effective system of internal control over financial reporting is necessary for
us to provide reliable financial reports. As disclosed in the Companys 2005 Annual Report on Form
10-K, managements assessment of the Companys internal control over financial reporting identified
material weaknesses in the Companys internal controls surrounding (i) the accounting for revenue
recognition; (ii) record keeping and
documentation; (iii) accounting personnel; (iv) financial statement close procedures; (v) the
inability of the Company to maintain an effective independent Internal Audit Department; (vi) the
existence of ineffective spreadsheet controls used in connection with the Companys financial
processes, including review, testing, access and integrity controls; (vii) the existence of
accounting system access rights granted to certain members of the Companys accounting and finance
46
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 the Companys
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. We have not
fully remediated these material weaknesses and as a result, management continues to conclude that
we did not maintain effective internal control over financial reporting as of March 31, 2006.
Because we have concluded that our internal control over financial reporting is not effective
as of March 31, 2006 and our independent registered public accountants issued a disclaimer opinion
on the effectiveness of our internal controls as of December 31, 2005 due to our inability to make
a timely assessment of the effectiveness of our internal controls, and to the extent we identify
future weaknesses or deficiencies, there could be material misstatements in our consolidated
financial statements and we could fail to meet our financial reporting obligations. As a result,
our ability to obtain additional financing, or obtain additional financing on favorable terms,
could be materially and adversely affected, which, in turn, could materially and adversely affect
our business, our strategic alternatives, our financial condition and the market value of our
securities. In addition, perceptions of us could also be adversely affected among customers,
lenders, investors, securities analysts and others. Current material weaknesses or any future
weaknesses or deficiencies could also hurt confidence in our business and consolidated financial
statements and our ability to do business with these groups.
Our revenue recognition policy has changed to the sell-through method which is currently not used
by most companies in the pharmaceutical industry which will make it more difficult to compare our
results to the results of our competitors.
Because our revenue recognition policy has changed to the sell-through method which reflects
products sold through the distribution channel, we do not recognize revenue for the domestic
product shipments of AVINZA, ONTAK, Targretin capsules and Targretin gel. Under our previous
method of accounting, product sales were recognized at time of shipment.
Under the sell-through revenue recognition method, future product sales and gross margins may
be affected by the timing of certain gross to net sales adjustments including the cost of certain
services provided by wholesalers under distribution service agreements, and the impact of price
increases. Cost of products sold and therefore gross margins for our products may also be further
impacted by changes in the timing of revenue recognition. Additionally, our revenue recognition
models incorporate a significant amount of third party data from our wholesalers and IMS. Such
data is subject to estimates and as such, any changes or corrections to these estimates identified
in later periods, such as changes or corrections occurring as a result of natural disasters or
other disruptions, including Hurricane Katrina, could affect the revenue that we report in future
periods.
As a result of our change in revenue recognition policy and the fact that the sell-through
method is not widely used by our competitors, it may be difficult for potential and current
stockholders to assess our financial results and compare these results to others in our industry.
This may have an adverse effect on our stock price.
Our new revenue recognition models under the sell-through method are extremely complex and depend
upon the accuracy and consistency of third party data as well as dependence upon key finance and
accounting personnel to maintain and implement the controls surrounding such models.
We have developed revenue recognition models under the sell-through method that are unique to
the Companys business and therefore are highly complex and not widely used in the pharmaceutical
industry. The revenue recognition models incorporate a significant amount of third party data from
our wholesalers and IMS. To effectively maintain the revenue recognition models, we depend to a
considerable degree upon the timely and accurate reporting to us of such data from these third
parties and our key accounting and finance personnel to
accurately interpolate such data into the models. If the third party data is not calculated
on a consistent basis and reported to us on an accurate or timely basis or we lose any of our key
accounting and finance personnel, the accuracy of our consolidated financial statements could be
materially affected. This could cause future delays in our earnings announcements, regulatory
filings with the SEC, and potential delays in relisting or delisting with the NASDAQ.
47
Changes in the estimated liability recognized under the termination and return of rights
transaction with Organon could be material in future periods and potentially result in adjustments
to our consolidated statements of operations that are inconsistent with the underlying trend in
AVINZA product sales.
As previously disclosed, on January 17, 2006, we signed an agreement with Organon that
terminated the AVINZA co-promotion agreement between the two companies and returned AVINZA rights
to Ligand. However, the parties have agreed to continue to cooperate during a transition period
ending September 30, 2006 (the Transition Period) to promote the product.
In consideration of the early termination and return of rights under the terms of the
agreement, Ligand will unconditionally pay Organon $37.75 million on or before October 15, 2006.
We will further pay Organon $10.0 million on or before January 15, 2007, provided that Organon has
made its minimum required level of sales calls. In addition, after the termination, we will make
quarterly payments to Organon equal to 6.5% of AVINZA net sales through December 31, 2012 and
thereafter 6% through patent expiration, currently anticipated to be November of 2017.
The unconditional payment of $37.75 million to Organon and the estimated fair value of the
amounts to be paid to Organon after the termination ($98.5 million as of March 31, 2006), based on
the 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 the approximation of the fair value of that service element of the agreement, is being
recognized ratably as additional co-promotion expense over the Transition Period.
Although the quarterly payments to Organon will be based on net reported AVINZA product sales,
such payments will not result in current period expense in the period upon which the payment is
based, but instead will be charged against the co-promote termination liability. The accretion to
the current net present value for each reporting period will, however, be recognized as interest
expense for that period at a rate of 15%, the discount rate used to initially value this component
of the termination liability. Additionally, any changes to our estimates of future net AVINZA
product sales will be recognized as an increase or decrease to earnings in the period such changes
are identified. Any such changes could be material and potentially result in adjustments to our
consolidated statements of operations that are inconsistent with the underlying trend in AVINZA
product sales.
Our common stock was delisted from the NASDAQ National Market which may reduce the price of our
common stock and the levels of liquidity available to our stockholders and cause confusion among
investors.
Our common stock was delisted from the NASDAQ National Market on September 7, 2005. Unless
and until the Companys common stock is relisted on NASDAQ, our common stock is expected to be
quoted on the Pink Sheets. The quotation of our common stock on the Pink Sheets may reduce the
price of our common stock and the levels of liquidity available to our stockholders. In addition,
the quotation of our common stock on the Pink Sheets may materially adversely affect our access to
the capital markets, and any limitation on liquidity or reduction in the price of our common stock
could materially adversely affect our ability to raise capital through alternative financing
sources on terms acceptable to us or at all. Stocks that are quoted on the Pink Sheets are no
longer eligible for margin loans, and a company quoted on the Pink Sheets cannot avail itself of
federal preemption of state securities or blue sky laws, which adds substantial compliance costs
to securities issuances, including pursuant to employee option plans, stock purchase plans and
private or public offerings of securities. Our delisting from the NASDAQ National Market and
quotation on the Pink Sheets may also have other negative implications, including the potential
loss of confidence by suppliers, customers and employees, the loss of institutional investor
interest and fewer business development opportunities.
While we have applied to have our common stock relisted on the NASDAQ National Market, our
common stock may not ultimately be relisted. Even if we are successful in getting our common stock
relisted on NASDAQ, the relisting may cause confusion among investors who have become accustomed to
our being quoted on the Pink Sheets as they seek to determine our stock price or trade in our
stock.
48
Our strategic alternatives exploration process is subject to a number of uncertainties and may or
may not result in any expected
transaction(s).
In November 2005, we announced that we would be exploring strategic alternatives for the
Company and its assets in order to enhance shareholder value. This process is ongoing and is
subject to a number of risks and uncertainties. For example, we may not decide to or be able to
complete any strategic transaction or series of transactions on any given timeframe, or at all.
Any transactions we do complete may not be the type of transaction or may not be on terms that some
stockholders or members of the investing public may prefer. Any of these risks or uncertainties
could harm our stock price.
Our small number of products and our dependence on partners and other third parties means our
results are vulnerable to setbacks with respect to any one product.
We currently have only five products approved for marketing and a handful of other
products/indications that have made significant progress through development. Because these numbers
are small, especially the number of marketed products, any significant setback with respect to any
one of them could significantly impair our operating results and/or reduce the market prices for
our securities. Setbacks could include problems with shipping, distribution, manufacturing, product
safety, marketing, government licenses and approvals, intellectual property rights and physician or
patient acceptance of the product, as well as higher than expected total rebates, returns or
discounts.
In particular, AVINZA our pain product, now accounts for a majority of our product revenues
and we expect AVINZA revenues will continue to grow over the next several years. Thus any setback
with respect to AVINZA could significantly impact our financial results and our share price.
AVINZA was licensed from Elan Corporation which is currently its sole manufacturer. We have
contracted with Cardinal to provide additional manufacturing capacity and expect to source product
from Cardinal in 2006. However, we expect Elan will continue to be a significant supplier over the
next several years. Any problems with Elans or Cardinals manufacturing operations or capacity
could reduce sales of AVINZA, as could any licensing or other contract disputes with these
suppliers.
Similarly, our co-promotion partner executes a large part of the marketing and sales efforts
for AVINZA and those efforts may be affected by our partners organization, operations, activities
and events both related and unrelated to AVINZA. Our co-promotion efforts have encountered and
continue to encounter a number of difficulties, uncertainties and challenges, including sales force
reorganizations and lower than expected sales call and prescription volumes, which have hurt and
could continue to hurt AVINZA sales growth. The negative impact on the products sales growth in
turn has caused and may continue to cause our revenues and earnings to be disappointing. Any
failure to fully optimize this co-promotion arrangement and the AVINZA brand, by either partner,
could also cause AVINZA sales and our financial results to be disappointing and hurt our stock
price. Any disputes with our co-promotion partner over these or other issues could harm the
promotion and sales of AVINZA and could result in substantial costs to us. In addition, in January
2006 we announced that we were terminating the co-promotion arrangement with a nine-month
transition period. Failure to successfully transition our partners efforts and functions back to
Ligand and/or failure to repartner or otherwise replace our partners sales activities for AVINZA
after the transition could adversely affect the sales of the product.
AVINZA is a relatively new product and therefore the predictability of its commercial results
is relatively low. 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 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 (DEA) to support our production requirements.
In particular, with respect to regulatory action and product safety issues, the FDA recently
requested that we expand the warnings on the AVINZA label to alert doctors and patients to the
dangers of using AVINZA with alcohol. We have made changes to the label. The FDA also requested
clinical studies to investigate the risks associated with taking AVINZA with alcohol. We have
submitted protocols to the FDA and are awaiting their
49
comments on these protocol designs. These
additional warnings, studies and any further regulatory action could have significant adverse
affects on AVINZA sales.
Our product development and commercialization involve 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 March
31, 2006, our accumulated deficit was approximately $973.3 million. We began receiving revenues
from the sale of pharmaceutical products in 1999. To consistently be profitable, we must
successfully develop, clinically test, market and sell our products. Even if we consistently
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 when we incur expenses and receive revenues from product
sales, collaborative arrangements and other sources. Some of these fluctuations may be significant.
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 recently received a non-approvable decision from the FDA and trials of
our market product Targretin failed to meet endpoints in Phase III trials in which we were studying
its use in non small cell lung cancer. There are many reasons that we or our collaborative
partners may fail in our efforts to develop our other potential products, including the possibility
that:
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preclinical testing or human studies may show that our potential products are ineffective or cause harmful side effects; |
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the products may fail to receive necessary regulatory approvals from the FDA or foreign authorities in a timely manner,
or at all; |
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the products, if approved, may not be produced in commercial quantities or at reasonable costs; |
Ø |
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the products, once approved, may not achieve commercial acceptance; |
Ø |
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regulatory or governmental authorities may apply restrictions to our products, which could adversely affect their
commercial success; or |
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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.
Third-party reimbursement and health care reform policies may reduce our future sales.
Sales of prescription drugs depend significantly on access to the formularies, or lists of
approved prescription drugs, of third-party payers such as government and private insurance plans,
as well as the availability of reimbursement to the consumer from these third party payers. These
third party payers frequently require drug companies to provide predetermined discounts from list
prices, and they are increasingly challenging the prices charged for medical products and services.
Our current and potential products may not be considered cost-effective, may not be added to
formularies and reimbursement to the consumer may not be available or sufficient to allow us to
sell our products on a competitive basis. For example, we have current and recurring discussions
with insurers regarding formulary access, discounts and reimbursement rates for our drugs,
including AVINZA. We may not be able to negotiate favorable reimbursement rates and formulary
status for our products or may have to
pay significant discounts to obtain favorable rates and access. Only one of our products,
ONTAK, is currently eligible to be reimbursed by Medicare (reimbursement for Targretin is being
provided to a small group of patients by Medicare through December 2005 as part of the Medicare
Replacement Drug Demonstration Project). Recently enacted changes by Medicare to the hospital
outpatient payment reimbursement system may adversely affect reimbursement rates for ONTAK.
Beginning in 2004 we have also experienced a significant increase in ONTAK units that are sold
through Disproportionate Share Hospitals or DSHs. These hospitals are part of the federal
governments procurement system and thus receive significantly higher rebates than non-government
purchasers of our products. As a result, our net revenues for ONTAK could be substantially reduced
if this trend continues.
50
In addition, the efforts of governments and third-party payers to contain or reduce the cost
of health care will continue to affect the business and financial condition of drug companies such
as us. A number of legislative and regulatory proposals to change the health care system have been
discussed in recent years, including price caps and controls for pharmaceuticals. These proposals
could reduce and/or cap the prices for our products or reduce government reimbursement rates for
products such as ONTAK. In addition, an increasing emphasis on managed care in the United States
has and will continue to increase pressure on drug pricing. We cannot predict whether legislative
or regulatory proposals will be adopted or what effect those proposals or managed care efforts may
have on our business. The announcement and/or adoption of such proposals or efforts could
adversely affect our profit margins and business.
We are building marketing and sales capabilities in the United States and Europe which is an
expensive and time-consuming process and may increase our operating losses.
Developing the sales force to market and sell products is a difficult, expensive and
time-consuming process. We have developed a US sales force of approximately 113 people as of March
31, 2006. We also rely on third-party distributors to distribute our products. The distributors
are responsible for providing many marketing support services, including customer service, order
entry, shipping and billing and customer reimbursement assistance. In Europe, we currently rely on
other companies to distribute and market our products. We have entered into agreements for the
marketing and distribution of our products in territories such as the United Kingdom, Germany,
France, Spain, Portugal, Greece, Italy and Central and South America and have established a
subsidiary, Ligand Pharmaceuticals International, Inc., with a branch in London, England, to
coordinate our European marketing and operations. Our reliance on these third parties means our
results may suffer if any of them are unsuccessful or fail to perform as expected. We may not be
able to continue to expand our sales and marketing capabilities sufficiently to successfully
commercialize our products in the territories where they receive marketing approval. With respect
to our co-promotion or licensing arrangements, for example our co-promotion agreement for AVINZA,
which is currently in transition, any revenues we receive will depend substantially on the
marketing and sales efforts of others, which may or may not be successful.
The cash flows from our product shipments may significantly fluctuate each period based on the
nature of our products.
Excluding AVINZA, our products are small-volume specialty pharmaceutical products that address
the needs of cancer patients in relatively small niche markets with substantial geographical
fluctuations in demand. To ensure patient access to our drugs, we maintain broad distribution
capabilities with inventories held at approximately 130 locations throughout the United States.
The purchasing and stocking patterns of our wholesaler customers for all our products are
influenced by a number of factors that vary from product to product, including but not limited to
overall level of demand, periodic promotions, required minimum shipping quantities and wholesaler
competitive initiatives. As a result, the overall level of product in the distribution channel may
average from two to six months worth of projected inventory usage. Although we have distribution
services contracts in place to maintain stable inventories at our major wholesalers, if any of them
were to substantially reduce the inventory they carry in a given period, e.g. due to circumstances
beyond their reasonable control, or contract termination or expiration, our shipments and cash flow
for that period could be substantially lower than historical levels.
We have entered into fee-for-service or distributor services agreements for each of our
products with the majority of our wholesaler customers. Under these agreements, in
exchange for a set fee, the wholesalers have
agreed to provide us with certain services. Concurrent with the implementation of these
agreements we will no longer routinely offer these wholesalers promotional discounts or incentives.
The agreements typically have a one-year initial term and are renewable.
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:
51
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 currently estimate our research and development expenditures over the next 3 years to range
between $180 million and $225 million. 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 and other factors. Any of these uncertain
events can significantly change our cash requirements as they determine such one-time events as the
receipt of major milestones and other payments.
While we expect to fund our research and development activities from cash generated from
internal operations to the extent possible, if we are unable to do so we may need to complete
additional equity or debt financings or seek other external means of financing. 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.
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, which could be converted into 25,149,025
shares of our common stock. During the three months ended March 31, 2006, holders of notes with a
face value of $26.1 million (approximately 17% of total outstanding notes) converted their notes
into approximately 4.2 million shares of our common stock.
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. 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.
Our products 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-
52
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.
In particular, we announced top-line data, or a summary of significant findings from our Phase
III trials for Targretin capsules in NSCLC in late March of 2005. The data analysis showed that
the trials did not meet their endpoints of improved overall survival and projected two-year
survival. However, in both trials, additional subset analyses completed after the initial intent
to treat results indicated that a subset (36%) of Targretin treated patients that developed high
triglycerideimia showed a significantly improved overall survival. We have been evaluating data
from current and prior Phase II studies to see if they show a similar correlation between
hypertriglyceridemia and increased survival. The data will further shape our future plans for
Targretin. If further studies are justified they will be conducted on our own or with a partner or
cooperative group. These analyses may not be favorable and may not be completed or demonstrate any
hypothesis or endpoint. If these analyses or subsequent data fails to show safety or
effectiveness, our stock price could be harmed. In addition, subsequent data may be inconclusive
or mixed and could be delayed. The FDA may not approve Targretin for this new indication, or may
delay approval, even if the data appears to be favorable. Any of these events could depress our
stock price.
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. For example,
each of our Phase III Targretin clinical trials involved approximately 600 patients and required
significant time and investment to complete enrollments. Delays in patient enrollment for our
other 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.
We face substantial competition which may limit our revenues.
Some of the drugs that we are developing and marketing will compete with existing treatments.
In addition, several companies are developing new drugs that target the same diseases that we are
targeting and are taking IR-related and STAT-related approaches to drug development. The principal
products competing with our products targeted at the cutaneous t-cell lymphoma market are
Supergen/Abbotts Nipent and interferon, which is marketed by a number of companies, including
Schering-Ploughs Intron A. Products that compete with AVINZA include Purdue Pharma L.P.s
OxyContin and MS Contin, Janssen Pharmaceutica L.P.s Duragesic, aai Pharmas
Oramorph SR, Alpharmas Kadian, and generic sustained release morphine sulfate, oxycodone and
fentanyl. New generic, A/B substitutable or other competitive products may also come to market and
compete with our products, reducing our market share and revenues. Many of our existing or
potential competitors, particularly large drug companies, have greater financial, technical and
human resources than we do and may be better equipped to develop, manufacture and market products.
Many of these companies also have extensive experience in preclinical testing and human clinical
trials, obtaining FDA and other regulatory approvals and manufacturing and marketing pharmaceutical
products. In addition, academic institutions, governmental agencies and other public and private
research organizations are developing products that may compete with the products we are
developing. These institutions are becoming more aware of the commercial value of their findings
and are seeking patent protection and licensing arrangements to collect payments for the use of
their technologies. These institutions also may market competitive products on their own or
through joint ventures and will compete with us in recruiting highly qualified scientific
personnel.
53
We rely heavily on collaborative relationships and termination of any of these programs could
reduce the financial resources available to us, including research funding and milestone payments.
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 provide 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 less support
and 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. 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. 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 collaborative research, development and commercialization of certain
potential products, 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.
Some of our key technologies have not been used to produce marketed products and may not be capable
of producing such products.
To date, we have dedicated most of our resources to the research and development of potential
drugs based upon our expertise in our IR technology. Even though there are marketed drugs that act
through IRs, some aspects of our IR technologies have not been used to produce marketed products.
Much remains to be learned about the function of IRs. If we are unable to apply our IR and STAT
technologies to the development of our potential products, we may not be successful in discovering
or developing new products.
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 and to avoid infringing the proprietary
rights of others, 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. 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.
Our patent position, like that of many 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. Further, the
manufacture, use or sale of our products may infringe the patent rights of others.
54
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. 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. While we routinely receive communications or have conversations with
the owners of other patents, none of these third parties have directly threatened an action or
claim against us. If other companies 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.
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.
Hoffmann-La Roche Inc. has received a US patent, has made patent filings and has issued
patents in foreign countries that relate to our Panretin gel products. While we were unsuccessful
in having certain claims of the US patent awarded to Ligand in interference proceedings, we
continue to believe that any relevant claims in these Hoffman-La Roche patents in relevant
jurisdictions are invalid and that our current commercial activities and plans relating to Panretin
are not covered by these Hoffman-La Roche patents in the US or elsewhere. In addition, we have our
own portfolio of issued and pending patents in this area which cover our commercial activities, as
well as other uses of 9-cis retinoic acid, in the US, Europe and elsewhere. However, if the claims
in these Hoffman-La Roche patents are not invalid and/or unenforceable, they might block the use of
Panretin gel in specified cancers, not currently under active development or commercialization by
us.
Novartis AG has filed an opposition to our European patent that covers the principal active
ingredient of our ONTAK drug. We have received a favorable preliminary opinion from the European
Patent Office, however this is not a final determination and Novartis has filed a response to the
preliminary opinion that argues our patent is invalid. If the opposition is successful, we could
lose our ONTAK patent protection in Europe which could substantially reduce our future ONTAK sales
in that region. We could also incur substantial costs in asserting our rights in this opposition
proceeding, as well as in other possible future proceedings in the United States.
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 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.
55
Reliance on third-party manufacturers to supply our products risks supply interruption or
contamination and difficulty controlling costs.
We currently have no manufacturing facilities, and we rely on others for clinical or
commercial production of our marketed and potential products. In addition, some raw materials
necessary for the commercial manufacturing of our products are custom and must be obtained from a
specific sole source. Elan manufactures AVINZA for us, Cambrex manufactures ONTAK
active pharmaceutical ingredient for us, Raylo manufactures Targretin active pharmaceutical
ingredient, and Cardinal Health manufactures Targretin capsules for us. We also recently entered
into contracts with and received regulatory approval during 2005 for Cardinal Health to manufacture
and package AVINZA and with Hollister-Stier for the filling and finishing of ONTAK. Any delays or
failures of the manufacturing or packaging process could cause inventory problems or product
shortages.
To be successful, we will need to ensure continuity of the manufacture of our products, either
directly or through others, in commercial quantities, in compliance with regulatory requirements at
acceptable cost and in sufficient quantities to meet product growth demands. Any extended or
unplanned manufacturing shutdowns, shortfalls or delays could be expensive and could result in
inventory and product shortages. If we are unable to reliably manufacture our products our
revenues could be adversely affected. In addition, if we are unable to supply products in
development, our ability to conduct preclinical testing and human clinical trials will be adversely
affected. This in turn could also delay our submission of products for regulatory approval and our
initiation of new development programs. In addition, although other companies have manufactured
drugs acting through IRs and STATs on a commercial scale, we may not be able to translate our core
technologies or other technologies into drugs that can be manufactured at costs or in quantities to
make marketable products.
The manufacturing process also may be susceptible to contamination, which could cause the
affected manufacturing facility to close until the contamination is identified and fixed. In
addition, problems with equipment failure or operator error also could cause delays in filling our
customers orders.
Our business exposes us to product liability risks or our products may need to be recalled, and we
may not have sufficient insurance to cover any claims.
Our business exposes us to potential product liability risks. Our products also 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 the business. 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.
Future sales of our securities may depress the price of our securities.
Sales of substantial amounts of our securities in the public market could seriously harm
prevailing market prices for our securities. These sales might make it difficult or impossible for
us to sell additional securities when we need to raise capital.
56
You may not receive a return on your securities other than through the sale of your securities.
We have not paid any cash dividends on our common stock to date. We intend to retain any
earnings to support the expansion of our business, and we do not anticipate paying cash dividends
on any of our securities in the foreseeable future.
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.
57
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On January 31, 2006, an aggregate of approximately 881 shares of our common stock were issued
to former employees of the Company in connection with certain option exercises under the Companys
2002 stock option plan. We received approximately $5,700 from the option exercises. The issuance
of shares of Company common stock to such individuals was exempt under Section 4(2) and Regulation
D of the Securities Act. The resale of these shares has been subsequently registered on a
post-effective amendment No. 1 to Form S-1 filed on April 12, 2006 and declared effective on April
25, 2006.
During the three months ended March 31, 2006, convertible notes with a face value of $26.1
million were converted into approximately 4.2 million shares of common stock. Each of the
recipients that was issued shares upon conversion of the convertible notes was an institutional
investor which had previously held the Companys convertible notes. The issuance of shares of
Company common stock to such investors was exempt under Section 3(a)(9) or alternatively under
Section 4(2) and Regulation D of the Securities Act.
58
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
We held an Annual Meeting of Stockholders on January 31, 2006. The following elections and
proposals were approved at the Annual Meeting:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Votes |
|
|
Votes |
|
|
Votes |
|
|
Votes |
|
|
Broker |
|
|
|
For |
|
|
Against |
|
|
Withheld |
|
|
Abstaining |
|
|
Non Votes |
|
1. Election of a Board of
Directors. The total
number of votes cast for,
or withheld for each
nominee was as follows: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Henry R. Blissenbach |
|
|
62,038,305 |
|
|
|
¾ |
|
|
|
8,643,702 |
|
|
|
¾ |
|
|
|
¾ |
|
Alexander D. Cross |
|
|
61,992,442 |
|
|
|
¾ |
|
|
|
8,689,565 |
|
|
|
¾ |
|
|
|
¾ |
|
John Groom |
|
|
68,092,327 |
|
|
|
¾ |
|
|
|
2,589,680 |
|
|
|
¾ |
|
|
|
¾ |
|
Irving S. Johnson |
|
|
68,103,326 |
|
|
|
¾ |
|
|
|
2,578,771 |
|
|
|
¾ |
|
|
|
¾ |
|
John W. Kozarich |
|
|
69,766,600 |
|
|
|
¾ |
|
|
|
915,407 |
|
|
|
¾ |
|
|
|
¾ |
|
Daniel S. Loeb |
|
|
70,267,468 |
|
|
|
¾ |
|
|
|
414,539 |
|
|
|
¾ |
|
|
|
¾ |
|
Carl C. Peck |
|
|
69,699,975 |
|
|
|
¾ |
|
|
|
982,032 |
|
|
|
¾ |
|
|
|
¾ |
|
Jeffrey R. Perry |
|
|
70,252,035 |
|
|
|
¾ |
|
|
|
429,972 |
|
|
|
¾ |
|
|
|
¾ |
|
Brigette Roberts |
|
|
70,231,204 |
|
|
|
¾ |
|
|
|
450,803 |
|
|
|
¾ |
|
|
|
¾ |
|
David E. Robinson |
|
|
69,578,436 |
|
|
|
¾ |
|
|
|
1,103,571 |
|
|
|
¾ |
|
|
|
¾ |
|
Michael A. Rocca |
|
|
62,096,599 |
|
|
|
¾ |
|
|
|
8,585,408 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2. Amendment of the
2002 Stock Incentive Plan
to increase the authorized
number of shares of common
stock available for
issuance under such plan
from 8,325,529 to 9,075,529 |
|
|
46,364,017 |
|
|
|
8,794,138 |
|
|
|
¾ |
|
|
|
105,355 |
|
|
|
15,418,497 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3. Ratification of the
appointment of BDO Seidman
LLP as the independent
auditors for the fiscal
year ending December 31,
2005. |
|
|
70,444,488 |
|
|
|
138,033 |
|
|
|
¾ |
|
|
|
99,486 |
|
|
|
¾ |
|
59
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. |
|
|
|
3.5 (3)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Company dated June 14, 2000. |
|
|
|
3.6 (4)
|
|
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Company dated September 30,
2004. |
|
|
|
3.7 (5)
|
|
Amendment to the Bylaws dated November 13, 2005 (Filed as Exhibit 3.1). |
|
|
|
4.1 (6)
|
|
Specimen stock certificate for shares of Common Stock of the Company. |
|
|
|
4.2 (7)
|
|
Preferred Shares Rights Agreement, dated as of September 13, 1996, by and between the Company and Wells Fargo Bank,
N.A. (Filed as Exhibit 10.1). |
|
|
|
4.3 (8)
|
|
Amendment to Preferred Shares Rights Agreement, dated as of November 9, 1998, between the Company and ChaseMellon
Shareholder Services, L.L.C., as Rights Agent. (Filed as Exhibit 99.1). |
|
|
|
4.4 (9)
|
|
Second Amendment to the Preferred Shares Rights Agreement, dated as of December 23, 1998, between the Company and
ChaseMellon Shareholder Services, L.L.C., as Rights Agent (Filed as Exhibit 1). |
|
|
|
4.7 (10)
|
|
Fourth Amendment to the Preferred Shares Rights Agreement and Certification of Compliance with Section 27 Thereof,
dated as of October 3, 2002, between the Company and Mellon Investor Services LLC, as Rights Agent. |
|
|
|
4.9 (11)
|
|
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). |
|
|
|
4.10 (11)
|
|
Form of 6% Convertible Subordinated Note due 2007. (Filed as Exhibit 4.4). |
|
|
|
4.11 (11)
|
|
Pledge Agreement dated November 26, 2002, between Ligand Pharmaceuticals Incorporated and J.P. Morgan Trust Company,
National Association. (Filed as Exhibit 4.5). |
|
|
|
4.12 (11)
|
|
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). |
|
|
|
4.13 (12)
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Amended and Restated Preferred Shares Rights Agreement dated as of March 30, 2004, which includes as Exhibit A the
Form of Rights Certificate and as Exhibit B the Summary of Rights. |
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10.267
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2002 Stock Incentive Plan (as amended and restated through March 9, 2006.) |
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10.292 (13)
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Form of Letter Agreement between the Company and certain officers dated
March 1, 2006. |
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31.1
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Certification by 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 by 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 by 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 by Principal Financial Officer, Pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002. |
60
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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) |
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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 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. 333-12603)
filed on September 25, 1996, as amended. |
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(8) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Registration Statement on Form 8-A/A Amendment No. 1 (No.
0-20720) filed on November 10, 1998. |
|
(9) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Registration Statement on Form 8-A/A Amendment No. 2 (No.
0-20720) filed on December 24, 1998. |
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(10) |
|
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, 2002. |
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(11) |
|
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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(12) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Form 8-A 12G/A, filed on April 6, 2004. |
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(13) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
number exhibit filed with the Companys current report on Form 8-K filed on March 7, 2006. |
61
LIGAND PHARMACEUTICALS INCORPORATED
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Date: May 15, 2006
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By: |
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/s/ Paul V. Maier |
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Paul V. Maier |
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Senior Vice President, Chief Financial Officer |
62