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 June 30, 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 July 31, 2006, the registrant had 78,740,945 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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June 30, 2006 |
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December 31, 2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
41,615 |
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$ |
66,756 |
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Short-term investments |
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19,168 |
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20,174 |
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Accounts receivable, net |
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18,667 |
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20,954 |
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Current portion of inventories, net |
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8,467 |
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9,333 |
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Other current assets |
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25,986 |
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15,750 |
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Total current assets |
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113,903 |
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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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5,211 |
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5,869 |
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Property and equipment, net |
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21,561 |
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22,483 |
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Acquired technology, product rights and royalty buy-down, net |
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139,766 |
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146,770 |
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Other assets |
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3,665 |
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4,704 |
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Total assets |
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$ |
285,932 |
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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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$ |
19,460 |
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$ |
15,360 |
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Accrued liabilities |
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58,302 |
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59,587 |
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Current portion of deferred revenue, net |
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143,102 |
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157,519 |
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Current portion of co-promote termination liability |
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45,046 |
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Current portion of equipment financing obligations |
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2,146 |
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2,401 |
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Current portion of long-term debt |
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356 |
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344 |
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Total current liabilities |
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268,412 |
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235,211 |
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Long-term debt |
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139,463 |
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166,745 |
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Long-term portion of co-promote termination liability |
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94,261 |
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Long-term portion of equipment financing obligations |
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2,851 |
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3,430 |
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Long-term portion of deferred revenue, net |
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4,100 |
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4,202 |
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Other long-term liabilities |
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3,002 |
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3,105 |
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Total liabilities |
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512,089 |
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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 June 30,
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, $0.001 par value; 200,000,000 shares
authorized; 77,730,044 and 73,136,340 shares
issued at June 30, 2006 and December 31, 2005,
respectively |
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78 |
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73 |
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Additional paid-in capital |
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751,547 |
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720,988 |
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Accumulated other comprehensive income |
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30 |
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490 |
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Accumulated deficit |
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(989,246 |
) |
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(831,059 |
) |
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(237,591 |
) |
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(109,508 |
) |
Treasury stock, at cost; 73,842 shares |
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(911 |
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(911 |
) |
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Total stockholders deficit |
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(238,502 |
) |
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(110,419 |
) |
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$ |
285,932 |
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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 June 30, |
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Six Months Ended June 30, |
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2006 |
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2005 |
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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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$ |
47,327 |
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$ |
41,735 |
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$ |
95,311 |
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$ |
76,780 |
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Collaborative research and development and other revenues |
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1,120 |
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4,064 |
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4,092 |
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6,004 |
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Total revenues |
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48,447 |
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45,799 |
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99,403 |
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82,784 |
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Operating costs and expenses: |
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Cost of products sold |
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10,266 |
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10,667 |
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20,006 |
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21,732 |
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Research and development |
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13,895 |
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14,524 |
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26,113 |
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29,259 |
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Selling, general and administrative |
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24,637 |
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20,149 |
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46,988 |
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39,364 |
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Co-promotion |
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11,073 |
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6,966 |
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21,880 |
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14,706 |
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Co-promote termination charges |
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(434 |
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132,507 |
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Total operating costs and expenses |
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59,437 |
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52,306 |
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247,494 |
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105,061 |
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Loss from operations |
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(10,990 |
) |
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(6,507 |
) |
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(148,091 |
) |
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(22,277 |
) |
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Other income (expense): |
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Interest income |
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587 |
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398 |
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1,160 |
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842 |
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Interest expense |
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(6,156 |
) |
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(3,030 |
) |
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(12,223 |
) |
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(6,157 |
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Other, net |
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619 |
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232 |
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1,002 |
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233 |
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Total other expense, net |
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(4,950 |
) |
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(2,400 |
) |
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(10,061 |
) |
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(5,082 |
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Loss before income taxes |
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(15,940 |
) |
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(8,907 |
) |
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(158,152 |
) |
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(27,359 |
) |
Income tax expense |
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(18 |
) |
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(17 |
) |
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(35 |
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(37 |
) |
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Net loss |
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$ |
(15,958 |
) |
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$ |
(8,924 |
) |
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$ |
(158,187 |
) |
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$ |
(27,396 |
) |
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Basic and diluted per share amounts: |
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Net loss |
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$ |
(0.20 |
) |
|
$ |
(0.12 |
) |
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$ |
(2.03 |
) |
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$ |
(0.37 |
) |
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Weighted average number of common shares |
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78,539,820 |
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74,036,753 |
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78,021,236 |
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73,976,939 |
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See accompanying notes.
4
LIGAND PHARMACEUTICALS INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
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Six Months Ended June 30, |
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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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$ |
(158,187 |
) |
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$ |
(27,396 |
) |
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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7,140 |
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6,806 |
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Depreciation and amortization of property and equipment |
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1,747 |
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1,865 |
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Amortization of debt issue costs |
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473 |
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512 |
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Gain on sale of Exelixis stock |
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(908 |
) |
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(233 |
) |
Stock-based compensation |
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2,043 |
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Non-cash interest expense converted into additional paid-in capital |
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60 |
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Other |
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(17 |
) |
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52 |
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Changes in operating assets and liabilities: |
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Accounts receivable, net |
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2,287 |
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|
9,831 |
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Inventories, net |
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1,524 |
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(3,283 |
) |
Other current assets |
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(10,236 |
) |
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|
4,789 |
|
Accounts payable and accrued liabilities |
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2,874 |
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|
(4,120 |
) |
Other liabilities |
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(19 |
) |
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|
(14 |
) |
Deferred revenue, net |
|
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(14,519 |
) |
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|
689 |
|
Co-promote termination liability |
|
|
139,307 |
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Net cash used in operating activities |
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(26,431 |
) |
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(10,502 |
) |
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Investing activities |
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Purchases of short-term investments |
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(12,694 |
) |
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(24,849 |
) |
Proceeds from sale of short-term investments |
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14,185 |
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|
9,683 |
|
Increase in restricted investments |
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(170 |
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Purchases of property and equipment |
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(674 |
) |
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(1,145 |
) |
Payment to buy-down ONTAK royalty obligation |
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(33,000 |
) |
Capitalized portion of payment of lasofoxifene royalty rights |
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(558 |
) |
Other, net |
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46 |
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|
146 |
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Net cash provided by (used in) investing activities |
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|
863 |
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(49,893 |
) |
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Financing activities |
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Principal payments on equipment financing obligations |
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(1,379 |
) |
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|
(1,449 |
) |
Proceeds from equipment financing arrangements |
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|
545 |
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|
|
1,390 |
|
Repayment of long-term debt |
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|
(170 |
) |
|
|
(159 |
) |
Proceeds from issuance of common stock |
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|
1,519 |
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|
|
920 |
|
Decrease in other long-term liabilities |
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|
(88 |
) |
|
|
(37 |
) |
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|
|
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Net cash provided by financing activities |
|
|
427 |
|
|
|
665 |
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|
|
|
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Net decrease in cash and cash equivalents |
|
|
(25,141 |
) |
|
|
(59,730 |
) |
Cash and cash equivalents at beginning of period |
|
|
66,756 |
|
|
|
92,310 |
|
|
|
|
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Cash and cash equivalents at end of period |
|
$ |
41,615 |
|
|
$ |
32,580 |
|
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Supplemental disclosure of cash flow information |
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Interest paid |
|
$ |
4,944 |
|
|
$ |
5,208 |
|
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|
|
|
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Non-cash impact of the conversion of 6% convertible subordinated notes
into common stock: |
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|
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Conversion of principal amount of convertible notes |
|
$ |
27,100 |
|
|
$ |
|
|
Conversion of unamortized debt issue costs |
|
|
(362 |
) |
|
|
|
|
Conversion of unpaid accrued interest |
|
|
264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
27,002 |
|
|
$ |
|
|
|
|
|
|
|
|
|
See accompanying notes.
5
LIGAND PHARMACEUTICALS INCORPORATED
Notes to Condensed Consolidated Financial Statements
(Unaudited)
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 and six-month periods ended June 30, 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 most important to both 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 28.4 million and
32.7 million at June 30, 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
6
these indemnification agreements is minimal and has no liabilities
recorded for these agreements as of June 30, 2006 and December 31, 2005.
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 June 30, 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 (SFAS) 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 and six months ended
June 30, 2006 was approximately $1.2 million and $2.0 million, respectively. There was no deferred
tax benefit recognized in connection with this cost.
Results for the three and six months ended June 30, 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 three and six months ended June 30, 2005 (in thousands, except per share
data):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 |
|
Net loss, as reported |
|
$ |
(8,924 |
) |
|
$ |
(27,396 |
) |
|
|
|
|
|
|
|
|
|
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 |
|
|
(781 |
) |
|
|
(1,538 |
) |
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 |
|
$ |
(9,705 |
) |
|
$ |
(41,389 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
Net loss per share as reported |
|
$ |
(0.12 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
Net loss per share pro forma |
|
$ |
(0.13 |
) |
|
$ |
(0.56 |
) |
|
|
|
|
|
|
|
|
|
|
(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 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 June 30, 2006,
options for 7,058,550 shares of common stock were outstanding under the 2002 plan and 545,101
shares remained available for future option grant or direct issuance.
The Company grants options to employees, non-employee consultants, and non-employee directors.
Additionally, the Company granted restricted stock to non-employee directors in the first quarter
of 2006.
8
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 $1.2 million and $2.0 million for the three and
six months ended June 30, 2006, respectively, associated with option awards and restricted stock.
Of the total compensation expense associated with option awards, approximately $0.01 million and
$0.2 million related to options granted to non-employee consultants for the three and six months
ended June 30, 2006, respectively.
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 |
|
Six Months Ended |
|
|
June 30 |
|
June 30 |
|
|
2006 |
|
2005 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.9 |
% |
|
|
3.7 |
% |
|
|
4.7 |
% |
|
|
3.7 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected volatility |
|
|
70 |
% |
|
|
73 |
% |
|
|
70 |
% |
|
|
73 |
% |
Expected term |
|
6.2 years |
|
5 years |
|
6.0 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 |
|
|
Intrinsic Value |
|
|
|
Shares |
|
|
Price |
|
|
in Years |
|
|
(in thousands) |
|
Balance at December 31, 2005 |
|
|
7,001,657 |
|
|
$ |
11.76 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
771,556 |
|
|
|
11.51 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(188,204 |
) |
|
|
8.12 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(139,335 |
) |
|
|
9.39 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(387,124 |
) |
|
|
13.84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
|
7,058,550 |
|
|
$ |
11.76 |
|
|
|
5.98 |
|
|
$ |
1,941 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2006 |
|
|
5,412,185 |
|
|
$ |
12.32 |
|
|
|
5.07 |
|
|
$ |
1,164 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options expected to vest as
of June 30, 2006 |
|
|
6,840,692 |
|
|
$ |
11.81 |
|
|
|
5.87 |
|
|
$ |
1,856 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of all stock options granted during the six months
ended June 30, 2006 was $7.65 per share. The total intrinsic value of all options exercised during
the six months ended June 30, 2006 was $0.75 million. As of June 30, 2006, there was approximately
$7.9 million of total unrecognized compensation cost related to nonvested stock options. That cost
is expected to be recognized over a weighted average period of 2.95 years.
Cash received from options exercised for the six months ended June 30, 2006 and 2005 was
approximately $1.5 million and $0.9 million, respectively. There is no current tax benefit related
to options exercised because of net operating losses (NOLs) for which a full valuation allowance
has been established.
Restricted Stock Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average Stock |
|
|
|
Shares |
|
|
Price |
|
Balance at December 31, 2005 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
15,566 |
|
|
|
11.56 |
|
Vested |
|
|
6,486 |
|
|
|
11.56 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at June 30, 2006 |
|
|
9,080 |
|
|
$ |
11.56 |
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of restricted stock granted during the six months
ended June 30, 2006 was $11.56 per share. As of June 30, 2006, there was $92,683 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 June 30, 2006, 362,738 shares of common stock had been issued under the ESPP, and 147,510 shares
are available for future issuance. For the six months ended June 30, 2006, there were no issuances
of common shares under the ESPP.
10
Accounts Receivable
Accounts receivable consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Trade accounts receivable |
|
$ |
8,629 |
|
|
$ |
1,344 |
|
Due from finance company (Note 2) |
|
|
10,746 |
|
|
|
20,464 |
|
Less: discounts and allowances |
|
|
(708 |
) |
|
|
(854 |
) |
|
|
|
|
|
|
|
|
|
$ |
18,667 |
|
|
$ |
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):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
1,852 |
|
|
$ |
1,508 |
|
Work-in-process |
|
|
9,337 |
|
|
|
9,115 |
|
Finished goods |
|
|
4,963 |
|
|
|
6,324 |
|
Less: inventory reserves |
|
|
(2,474 |
) |
|
|
(1,745 |
) |
|
|
|
|
|
|
|
|
|
|
13,678 |
|
|
|
15,202 |
|
Less: current portion |
|
|
(8,467 |
) |
|
|
(9,333 |
) |
|
|
|
|
|
|
|
Long-term portion of inventories, net |
|
$ |
5,211 |
|
|
$ |
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 June 30, 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 June 30, 2006 and December 31, 2005, total ONTAK inventory
amounted to approximately $7.4 million and $7.8 million, respectively, of which $3.2 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 June 30, 2006 and December 31, 2005, total
Targretin capsules inventory amounted to $3.2 million and $4.2 million, respectively, of which $2.0
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):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Land |
|
$ |
5,176 |
|
|
$ |
5,176 |
|
Equipment, building, and leasehold improvements |
|
|
62,254 |
|
|
|
61,732 |
|
Less accumulated depreciation and amortization |
|
|
(45,869 |
) |
|
|
(44,425 |
) |
|
|
|
|
|
|
|
|
|
$ |
21,561 |
|
|
$ |
22,483 |
|
|
|
|
|
|
|
|
11
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.
Other Current Assets
Other current assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred royalty cost |
|
$ |
4,753 |
|
|
$ |
5,203 |
|
Deferred cost of products sold |
|
|
5,332 |
|
|
|
5,103 |
|
Prepaid insurance |
|
|
535 |
|
|
|
1,071 |
|
Prepaid other |
|
|
2,324 |
|
|
|
2,807 |
|
Due from insurance company (Note 5) |
|
|
12,000 |
|
|
|
|
|
Other |
|
|
1,042 |
|
|
|
1,566 |
|
|
|
|
|
|
|
|
|
|
$ |
25,986 |
|
|
$ |
15,750 |
|
|
|
|
|
|
|
|
Other Assets
Other assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Prepaid royalty buyout, net |
|
$ |
2,176 |
|
|
$ |
2,312 |
|
Debt issue costs, net |
|
|
1,358 |
|
|
|
2,193 |
|
Other |
|
|
131 |
|
|
|
199 |
|
|
|
|
|
|
|
|
|
|
$ |
3,665 |
|
|
$ |
4,704 |
|
|
|
|
|
|
|
|
Amortization of debt issue costs was $0.2 million and $0.3 million for the three months ended
June 30, 2006 and 2005, respectively, and $0.5 million for both six month periods ended June 30,
2006 and 2005. Estimated annual amortization of this asset in each of the years in the period from
2006 through 2007 is approximately $1.0 million. As further discussed under Long-term Debt,
during the three and six months ended June 30, 2006, convertible notes with a face value of $1.0
million and $27.1 million, respectively, were converted into approximately 0.2 million and 4.4
million shares of common stock. In connection with the conversions, unamortized debt issue costs of
$0.01 million and $0.4 million for the three and six months ended June 30, 2006, respectively, 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 June 30, 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
12
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.
Acquired technology, product rights, and royalty buy-down, net consist of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
114,437 |
|
|
$ |
114,437 |
|
Less accumulated amortization |
|
|
(27,540 |
) |
|
|
(23,725 |
) |
|
|
|
|
|
|
|
|
|
|
86,897 |
|
|
|
90,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONTAK |
|
|
78,312 |
|
|
|
78,312 |
|
Less accumulated amortization |
|
|
(25,443 |
) |
|
|
(22,254 |
) |
|
|
|
|
|
|
|
|
|
|
52,869 |
|
|
|
56,058 |
|
|
|
|
|
|
|
|
|
|
$ |
139,766 |
|
|
$ |
146,770 |
|
|
|
|
|
|
|
|
Amortization of acquired technology, product rights and royalty buy-down, net was $3.5 million
and $7.0 million for the three and six months ended June 30, 2006 and $3.5 million and $6.7
million, respectively, 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.
13
The composition of deferred revenue, net is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred product revenue |
|
$ |
144,526 |
|
|
$ |
158,030 |
|
Other deferred revenue |
|
|
4,398 |
|
|
|
5,296 |
|
Deferred discounts |
|
|
(1,722 |
) |
|
|
(1,605 |
) |
|
|
|
|
|
|
|
Deferred revenue, net |
|
$ |
147,202 |
|
|
$ |
161,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, net: |
|
|
|
|
|
|
|
|
Current, net |
|
$ |
143,102 |
|
|
$ |
157,519 |
|
Long term, net |
|
|
4,100 |
|
|
|
4,202 |
|
|
|
|
|
|
|
|
|
|
$ |
147,202 |
|
|
$ |
161,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred product revenue, net (1): |
|
|
|
|
|
|
|
|
Current |
|
$ |
142,804 |
|
|
$ |
156,425 |
|
Long term |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
142,804 |
|
|
$ |
156,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other deferred revenue: |
|
|
|
|
|
|
|
|
Current |
|
$ |
298 |
|
|
$ |
1,094 |
|
Long term |
|
|
4,100 |
|
|
|
4,202 |
|
|
|
|
|
|
|
|
|
|
$ |
4,398 |
|
|
$ |
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. |
Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Allowances for loss on returns, rebates, chargebacks, other
discounts, ONTAK end-customer and Panretin product returns |
|
$ |
15,679 |
|
|
$ |
15,729 |
|
Co-promotion |
|
|
14,406 |
|
|
|
24,778 |
|
Distribution services |
|
|
3,324 |
|
|
|
4,044 |
|
Compensation |
|
|
6,084 |
|
|
|
5,746 |
|
Securities class action and derivative lawsuit liability (1) |
|
|
12,150 |
|
|
|
|
|
Royalties |
|
|
2,430 |
|
|
|
1,994 |
|
Seragen purchase liability (1) |
|
|
|
|
|
|
2,925 |
|
Interest |
|
|
961 |
|
|
|
1,164 |
|
Other |
|
|
3,268 |
|
|
|
3,207 |
|
|
|
|
|
|
|
|
|
|
$ |
58,302 |
|
|
$ |
59,587 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Refer to Note 5. Litigation. |
14
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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses on |
|
|
|
|
|
|
Care |
|
|
|
|
|
|
ONTAK End- |
|
|
|
|
|
|
Returns Due |
|
|
|
|
|
|
Rebates and |
|
|
|
|
|
|
customer and |
|
|
|
|
|
|
to Changes |
|
|
Medicaid |
|
|
Other |
|
|
|
|
|
|
Panretin |
|
|
|
|
|
|
In Price |
|
|
Rebates |
|
|
Rebates |
|
|
Chargebacks |
|
|
Returns |
|
|
Total |
|
Six Months Ended June 30, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
$ |
4,038 |
|
|
$ |
5,348 |
|
|
$ |
3,467 |
|
|
$ |
200 |
|
|
$ |
2,676 |
|
|
$ |
15,729 |
|
Provision |
|
|
2,292 |
|
|
|
2,999 |
|
|
|
6,469 |
|
|
|
3,099 |
|
|
|
1,192 |
|
|
|
16,051 |
|
Payments |
|
|
¾ |
|
|
|
(6,560 |
) |
|
|
(3,053 |
) |
|
|
(2,873 |
) |
|
|
¾ |
|
|
|
(12,486 |
) |
Charges |
|
|
(2,421 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(1,194 |
) |
|
|
(3,615 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
$ |
3,909 |
|
|
$ |
1,787 |
|
|
$ |
6,883 |
|
|
$ |
426 |
|
|
$ |
2,674 |
|
|
$ |
15,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term Debt
Long-term debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
6% Convertible Subordinated Notes |
|
$ |
128,150 |
|
|
$ |
155,250 |
|
Note payable to bank |
|
|
11,669 |
|
|
|
11,839 |
|
|
|
|
|
|
|
|
|
|
|
139,819 |
|
|
|
167,089 |
|
Less current portion |
|
|
(356 |
) |
|
|
(344 |
) |
|
|
|
|
|
|
|
Long-term debt |
|
$ |
139,463 |
|
|
$ |
166,745 |
|
|
|
|
|
|
|
|
During the three and six months ended June 30, 2006, certain holders of the Companys
outstanding 6% convertible subordinated notes converted notes with face values of $1.0 million and
$27.1 million into approximately 0.2 million and 4.4 million shares, respectively, of common stock.
In connection with the note conversions, accrued interest related to the converted notes for the
three and six months ended June 30, 2006, of $0.01 million and $0.3 million, respectively, was also
converted into common stock and recorded to additional paid-in capital. In addition, in connection
with the note conversions, unamortized debt issue costs for the three and six months ended June 30,
2006, of $0.01 million and $0.4 million, respectively, were recorded to additional paid-in capital.
15
Condensed Changes in Stockholders Deficit
Condensed changes in stockholders deficit for the six months ended June 30, 2006 are as
follows (in thousands, except share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
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 |
|
|
203,770 |
|
|
|
1 |
|
|
|
1,518 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
1,519 |
|
Issuance of common stock on
conversion of debt |
|
|
4,389,934 |
|
|
|
4 |
|
|
|
26,998 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
27,002 |
|
Unrealized gains/(losses)
on available-for-sale
securities |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(445 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(445 |
) |
Foreign currency
translation adjustments |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(15 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(15 |
) |
Equity- based compensation |
|
|
¾ |
|
|
|
¾ |
|
|
|
2,043 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
2,043 |
|
Net loss |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(158,187 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
(158,187 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2006 |
|
|
77,730,044 |
|
|
$ |
78 |
|
|
$ |
751,547 |
|
|
$ |
30 |
|
|
$ |
(989,246 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
(238,502 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net loss as reported |
|
$ |
(15,958 |
) |
|
$ |
(8,924 |
) |
|
$ |
(158,187 |
) |
|
$ |
(27,396 |
) |
Unrealized gains (losses) on
available-for-sale securities |
|
|
(979 |
) |
|
|
340 |
|
|
|
(445 |
) |
|
|
(620 |
) |
Foreign currency translation adjustments |
|
|
(12 |
) |
|
|
(22 |
) |
|
|
(15 |
) |
|
|
(29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(16,949 |
) |
|
$ |
(8,606 |
) |
|
$ |
(158,647 |
) |
|
$ |
(28,045 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The components of accumulated other comprehensive income are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Net unrealized holding gain on
available-for-sale securities |
|
$ |
298 |
|
|
$ |
743 |
|
Net unrealized loss on foreign
currency translation |
|
|
(268 |
) |
|
|
(253 |
) |
|
|
|
|
|
|
|
|
|
$ |
30 |
|
|
$ |
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
16
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 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:
|
|
|
|
|
|
|
|
|
Method |
|
Revenue Recognition Event |
|
Patent 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 and six months ended June 30, 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 June 30, 2006 were $47.3
million compared to $41.7 million for the same 2005 period. Total product sales for the six months
ended June 30, 2006 were $95.3 million compared to $76.8 million for the same 2005 period. A
comparison of sales by product is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
33,651 |
|
|
$ |
27,461 |
|
|
$ |
66,146 |
|
|
$ |
49,458 |
|
ONTAK |
|
|
8,204 |
|
|
|
8,779 |
|
|
|
17,386 |
|
|
|
16,803 |
|
Targretin capsules |
|
|
4,996 |
|
|
|
4,671 |
|
|
|
9,998 |
|
|
|
8,686 |
|
Targretin gel and Panretin gel |
|
|
476 |
|
|
|
824 |
|
|
|
1,781 |
|
|
|
1,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
47,327 |
|
|
$ |
41,735 |
|
|
$ |
95,311 |
|
|
$ |
76,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
17
The composition of collaborative research and development and other revenues is as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Collaborative research and development |
|
$ |
784 |
|
|
$ |
862 |
|
|
$ |
1,678 |
|
|
$ |
1,724 |
|
Development milestones and other |
|
|
336 |
|
|
|
3,202 |
|
|
|
2,414 |
|
|
|
4,280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,120 |
|
|
$ |
4,064 |
|
|
$ |
4,092 |
|
|
$ |
6,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 30,
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 and six months
ended June 30, 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 June 30, 2006 and December 31, 2005, the Company had received cash of $18.7 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 June 30, 2006
and December 31, 2005 was $10.7 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
18
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 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.
In August 2006, Ligand paid Salk $0.8 million to exercise an option to buy out milestone
payments, other payment sharing obligations and royalty payments due on future sales of
bazedoxifene, a product being developed by Wyeth. This payment resulted from a bazedoxifene NDA
filed by Wyeth for postmenopausal osteoporosis therapy. The Company will recognize the $0.8
million payment as development expense in its third quarter 2006 consolidated financial statements.
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
19
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 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 ($95.2 million as of January 1, 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
and six months ended June 30, 2006, the pro-rata recognition of this element of co-promotion
expense amounted to $3.3 million and $6.6 million, respectively.
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 and six months ended June 30, 2006 was $3.5
million and $6.8 million, respectively.
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
20
any such changes on its results of operations or financial position. For the three months ended June
30, 2006, the Company recorded a reduction in the co-promote termination liability and a
corresponding increase to earnings of $0.4 million based on the Companys updated estimate of
future AVINZA net sales.
The components of the co-promote termination liability as of June 30, 2006 are as follows (in
thousands):
|
|
|
|
|
Payment due October 15, 2006 |
|
$ |
37,750 |
|
Net present value of payments based on estimated future net
AVINZA product sales as of January 1, 2006 |
|
|
95,191 |
|
Reduction in net present value of liability resulting from
updated estimate of net AVINZA product sales as of June 30,
2006 |
|
|
(434 |
) |
Accretion of interest expense to net present value of
payments based on net AVINZA product sales as of June 30,
2006 |
|
|
6,800 |
|
|
|
|
|
|
|
|
139,307 |
|
Less: current portion of co-promote termination liability |
|
|
(45,046 |
) |
|
|
|
|
Long-term portion of co-promote termination liability |
|
$ |
94,261 |
|
|
|
|
|
5. Litigation
Securities Litigation
Since August 2004, the Company has been involved in several securities class action and
shareholder derivative actions which followed announcements by the Company in 2004 and the
subsequent restatement of its financial results in 2005. In June 2006, the Company announced that
these lawsuits had been settled, subject to certain conditions such as court approval.
Background
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.
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 were in
the discovery phase.
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
21
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.
The Settlement Agreements
The Company has entered into agreements to resolve all claims by the parties in each of these
matters, including those asserted against the Company and the individual defendants in these cases.
Under the agreements, the Company will pay a total of $12.2 million in cash for a release and in
full settlement of all claims. The $12.2 million settlement and a portion of the Companys legal
expenses will be funded by the Companys Directors and Officers Liability insurance carrier while
the remainder of the legal fees incurred ($1.4 million for the three months ended June 30, 2006)
will be paid by the Company. Of the $12.2 million settlement liability, $4.2 million will be paid
to the Company directly from the insurance carrier and then disbursed to the claimants attorneys,
while the remaining $8.0 million will be paid by the insurance carrier directly to an independent
escrow agent responsible for disbursing the funds to the claimants. Accordingly, the Company has
recorded $12.2 million as an accrued liability with a corresponding receivable from the Companys
insurance carrier on the Companys balance sheet as of June 30, 2006. In July 2006, the Companys
insurance carrier funded the escrow account with the $8.0 million to be disbursed to the claimants.
Under SFAS No. 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities, funding of the escrow account represents the extinguishment of the
Companys liability to the claimants. Accordingly, the Company will derecognize the $8.0 million
receivable and accrued liability in its consolidated financial statements as of September 30,
2006.. As part of the settlement of the state derivative action, the Company has agreed to adopt
certain corporate governance enhancements including the formalization of certain Board practices
and responsibilities, a Board self-evaluation process, Board and Board Committee term limits (with
gradual phase-in) and one-time enhanced independent requirements for a single director to succeed
the current shareholder representatives on the Board. Neither the Company nor any of its current or
former directors and officers has made any admission of liability or wrongdoing. The United States
District Court has preliminarily approved the settlement of the class action, however, that
settlement and the settlement of the derivative actions are all subject to final approval by the
courts in which they are pending.
SEC Investigation and Other Matters
In connection with the restatement of the Companys consolidated financial statements, the SEC
instituted a formal investigation concerning the consolidated financial statements. These matters
were previously the subject of an informal SEC inquiry. Ligand has been cooperating fully with the
SEC and will continue to do so in order to bring the investigation to a conclusion as promptly as
possible.
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,
22
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 June 30, 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.
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 Positions (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. The 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.
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.
In July 2006, the FASB issued FASB Interpretation No. 48 (FIN 48) Accounting for Uncertainty
in Income Taxes- an interpretation of FASB Statement No. 109. FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in a companys financial statements in accordance with FASB
Statement No. 109. It prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax position taken or expected to be taken in
a tax return. Additionally, FIN 48 provides guidance on derecognition,
23
classification, interest
and penalties, accounting in interim periods, disclosure, and transition. FIN 48 is effective for
fiscal years beginning after December 15, 2006. The adoption of FIN 48 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 paid and expensed in the fourth quarter of 2005. A second payment of
approximately $0.2 million was made and expensed in the second quarter of 2006. Third Point will
not sell its Ligand shares, solicit proxies or take certain other stockholder actions 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 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
$2.6 million would be made in January 2007 if all participants qualify for the payments. In
accordance with 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 and six months ended June 30, 2006, the Company recognized approximately
$0.8 million and $1.1 million, respectively, 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. LY818 (Naveglitazar)
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 Naveglitazar and does not affect the ongoing development activities of LY 674 or the
status of preclinical PPAR agonists.
10. NASDAQ Relisting
On June 12, 2006, NASDAQ approved the Companys application for relisting its common stock on
the NASDAQ Global Market (formerly National Market). The Company commenced trading on the NASDAQ
Global Market on June 14, 2006, under the symbol LGND. The Companys common stock was previously
delisted from the NASDAQ National Market on September 7, 2005.
11. Termination of Supply Agreement
On June 6, 2006, following the acquisition of Raylo Chemicals, Inc. (Raylo) by a third party,
the Company received written notice from Raylo of its intention to terminate its supply agreement
with Ligand. The agreement is to terminate on June 8, 2008. Raylo manufactures the Targretin
active pharmaceutical ingredient for the Company.
24
The Company will need to replace this manufacturing capability in time to ensure uninterrupted
supply of Targretin to the market. If it is unable to timely identify and contract with another
manufacturer, or if such manufacturer is delayed in receiving regulatory approval or beginning a
successful manufacturing program, sales of Targretin could be harmed.
12. Subsequent Events
On July 31, 2006, the Company entered into a separation agreement with David Robinson
providing for Mr. Robinsons resignation as Chairman, President, and Chief Executive Officer of the
Company. Under the separation agreement, Mr. Robinson will receive his base salary and certain
benefits for 24 months, payable in five equal monthly installments beginning August 1, 2006 and
ending December 1, 2006. In addition, the agreement provides for the immediate vesting of Mr.
Robinsons unvested stock options and an extension of the exercise period of his options to January
15, 2007. In connection with the resignation, the Company will recognize an expense of
approximately $2.1 million in its third quarter 2006 financial statements, comprised of cash
payments of $1.4 million and stock based compensation of $0.7 million associated with the
modification of the vesting and exercise period of the stock options.
On August 1, 2006, the Company announced that current director Henry F. Blissenbach had been
named Chairman and interim Chief Executive Officer. The Company has agreed to pay Dr. Blissenbach
$75,000 per month, commencing August 1, 2006, subject to cancellation by either party on thirty
days notice, for his services as Chairman and interim Chief Executive Officer. In addition, Dr.
Blissenbach will be eligible to receive incentive compensation of up to 50% of his base salary, but
not more than $150,000, based upon his performance of certain objectives to be agreed upon and
incorporated into an employment agreement which the Company and Dr. Blissenbach will enter into.
Also, Dr. Blissenbach received a special stock option grant to purchase 150,000 shares of the
Companys common stock at an exercise price equal to the closing price of the Companys common
stock on August 3, 2006 as reported on The NASDAQ Global Market. These stock options will vest 50%
at the end of six months and the remaining 50% will vest at the end of one year, except that all of
these stock options will vest upon the appointment of a new Chief Executive Officer. Finally, the
Company will reimburse Dr. Blissenbach for all reasonable expenses incurred in discharging his
duties as interim Chief Executive Officer, including, but not limited to commuting costs to San
Diego and living and related costs during the time he spends in San Diego.
25
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, 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, 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 SEC investigation related to the Companys 2005 restatement of financial results or
future litigation 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 ®
AVINZA®,
ONTAK®,
Panretin®
and
Targretin®.
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.
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
26
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 ($95.2 million as of January 1, 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
and six months ended June 30, 2006, the pro-rata recognition of this element of co-promotion
expense amounted to $3.3 million and $6.6 million, respectively.
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 expense for the
three and six months ended June 30, 2006 totaled $3.5 million, and $6.8 million, respectively.
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.
27
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. For the three months ended June 30, 2006, we recognized a
reduction in the co-promote termination liability and a corresponding increase to earnings of $0.4
million based on our updated estimate of future AVINZA net sales.
In June 2006, we concluded 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, 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 June 30, 2006, for which we incurred a net loss of $16.0 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 six months ended
June 30, 2006, based on grant-date fair value estimated in accordance with the provisions of SFAS
123(R). Results for the three and six months ended June 30, 2005 have not been retrospectively
adjusted. The implementation of SFAS 123(R) resulted in employee compensation expense of
approximately $1.2 million and $1.8 million for the three and six months ended June 30, 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.
28
Conversion of 6% Convertible Subordinated Notes
For the three and six months ended June 30, 2006, certain holders of our 6% convertible
subordinated notes converted notes with a face value of $1.0 million and $27.1 million into
approximately 0.2 million and 4.4 million shares of common stock, respectively.
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 $2.6 million would be made in January 2007 if all participants qualify for the
payments. In accordance with the 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 and six months ended June 30, 2006, the Company recognized
approximately $0.8 million and $1.0 million, respectively, 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 Naveglitazar and does not affect the ongoing development activities of LY 674 or the status of
preclinical PPAR agonists.
Agreements to Settle Securities Class Action and Derivative Lawsuits
On June 29, 2006, we announced that we reached agreement to settle the securities class action
litigation filed in the United States District Court for the Southern District of California
against us and certain of our directors and officers. In addition, we also reached agreement to
settle the shareholder derivative actions filed on behalf of the Company in the Superior Court of
California and the United States District Court for the Southern District of California.
The settlements, which are subject to court approval, resolve all claims by the parties,
including those asserted against Ligand and the individual defendants in these cases. Under the
agreements, we will pay a total of $12.2 million in cash in full settlement of all claims. The
$12.2 million settlement amount and a portion of our total legal expenses will be funded by our
Directors and Officers Liability insurance carrier while the remainder of the legal fees incurred
($1.4 million for the three months ended June 30, 2006) will be paid by us. Of the $12.2 million
settlement liability, $4.2 million will be paid to us directly from the insurance carrier and then
disbursed to the claimants attorneys while the remaining $8.0 million will be paid by the
insurance carrier directly to an independent escrow agent responsible for disbursing the funds to
the class action suit claimants. Accordingly, we have recorded $12.2 million as an accrued
liability with a corresponding receivable from our insurance carrier on our balance sheet as of
June 30, 2006. In July 2006, our insurance carrier funded the escrow account with the $8.0 million
to be disbursed to the claimants. Under SFAS No. 140, Accounting for Transfers and Servicing of
Financial Assets and Extinguishments of Liabilities, funding of the escrow account represents the
extinguishment of our liability to the claimants. Accordingly, we will derecognize the $8.0
million receivable and accrued liability in our consolidated financial statements as of September
30, 2006. As part of the settlement of the state derivative action, we have agreed to adopt certain
corporate governance enhancements including the formalization of certain Board practices and
responsibilities, a Board self-evaluation process, Board and Board Committee term limits (with
gradual phase-in) and one-time enhanced independent requirements for a single director to succeed
the current shareholder representatives on the Board. Neither we nor any of our current or former
directors and officers has made any admission of liability or wrongdoing. The United States
District Court has preliminarily approved the
29
settlement of the class action, however, that
settlement and the settlement of the derivative actions are all subject to final approval by the
courts in which they are pending.
The related investigation by the Securities and Exchange Commission is ongoing and is not
affected by the settlements discussed above.
Termination of Supply Agreement
On June 6, 2006, following the acquisition of Raylo Chemicals, Inc. (Raylo) by a third party,
we received written notice from Raylo of its intention to terminate its supply agreement with us
effective June 8, 2008. Raylo manufactures the Targretin active pharmaceutical ingredient for us.
Salk Royalty Buyout
In August 2006, we paid Salk $0.8 million to exercise an option to buy out milestone payments,
other payment sharing obligations and royalty payments due on future sales of bazedoxifene, a
product being developed by Wyeth. This payment resulted from a bazedoxifene new drug application
(NDA) filed by Wyeth for postmenopausal osteoporosis therapy. We will recognize the $0.8 million
payment as development expense in our third quarter 2006 consolidated financial statements.
Resignation of CEO and Appointment of New Interim CEO
On July 31, 2006, we entered into a separation agreement with David Robinson providing for Mr.
Robinsons resignation as Chairman, President, and Chief Executive Officer of the Company. Under
the separation agreement, Mr. Robinson will receive his base salary and certain benefits for 24
months, payable in five equal monthly installments beginning August 1, 2006 and ending December 1,
2006. In addition, the agreement provides for the immediate vesting of Mr. Robinsons unvested
stock options and an extension of the exercise period of his options to January 15, 2007. In
connection with the resignation, we will recognize an expense of approximately $2.1 million in our
third quarter 2006 financial statements, comprised of cash payments of $1.4 million and stock based
compensation of $0.7 million associated with the modification of the vesting and exercise period of
the stock options.
On August 1, 2006, we announced that current director Henry F. Blissenbach had been named
Chairman and interim Chief Executive Officer. We have agreed to pay Dr. Blissenbach $75,000 per
month, commencing August 1, 2006, subject to cancellation by either party on thirty days notice,
for his services as Chairman and interim Chief Executive Officer. In addition, Dr. Blissenbach
will be eligible to receive incentive compensation of up to 50% of his base salary, but not more
than $150,000, based upon his performance of certain objectives to be agreed upon and incorporated
into an employment agreement which we and Dr. Blissenbach will enter into. Also, Dr. Blissenbach
received a special stock option grant to purchase 150,000 shares of our common stock at an exercise
price equal to the closing price of our common stock on August 3, 2006 as reported on The NASDAQ
Global Market. These stock options will vest 50% at the end of six months and the remaining 50%
will vest at the end of one year, except that all of these stock options will vest upon the
appointment of a new Chief Executive Officer. Finally, we will reimburse Dr. Blissenbach for all
reasonable expenses incurred in discharging his duties as interim Chief Executive Officer,
including, but not limited to commuting costs to San Diego and living and related costs during the
time he spends in San Diego.
Results of Operations
Total revenues for the three and six months ended June 30, 2006 were $48.5 million and $99.4
million compared to $45.8 million and $82.8 million, respectively, for the same 2005 period. Loss
from operations was $11.0 million and $148.1 million for the three and six months ended June 30,
2006 compared to $6.5 million and $22.3 million, respectively, for the same 2005 period. Net loss
for the three and six months ended June 30, 2006 was $16.0 million ($0.20 per share) and $158.2
million ($2.03 per share) compared to $8.9 million ($0.12 per share) and $27.4 million ($0.37 per
share) for the same 2005 period.
30
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 June 30, 2006 was 3.9% compared to 4.5% for 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 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 benefit in the second half of
2006 from improving reimbursement rates under certain government reimbursement programs. We may
continue to experience quarter to quarter fluctuations in demand, however, as hospitals and clinics
administering ONTAK adjust to the changing reimbursement environment.
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 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.
31
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:
|
|
|
|
|
|
|
|
|
Method |
|
Revenue Recognition Event |
|
Patent 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 and six months ended June 30, 2006 and 2005, net product sales recognized under
the sell-through method represented approximately 96% of total net product sales in both periods.
Our total net product sales for the three and six months ended June 30, 2006 were $47.3
million and $95.3 million compared to $41.7 million and $76.8 million for the same 2005 period. A
comparison of sales by product is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
33,651 |
|
|
$ |
27,461 |
|
|
$ |
66,146 |
|
|
$ |
49,458 |
|
ONTAK |
|
|
8,204 |
|
|
|
8,779 |
|
|
|
17,386 |
|
|
|
16,803 |
|
Targretin capsules |
|
|
4,996 |
|
|
|
4,671 |
|
|
|
9,998 |
|
|
|
8,686 |
|
Targretin gel and Panretin gel |
|
|
476 |
|
|
|
824 |
|
|
|
1,781 |
|
|
|
1,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
47,327 |
|
|
$ |
41,735 |
|
|
$ |
95,311 |
|
|
$ |
76,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVINZA
Sales of AVINZA were $33.7 million and $66.1 million for the three and six months ended June
30, 2006 compared to $27.5 million and $49.5 million, respectively, for the same 2005 period. The
increase in sales for the three and six months ended June 30, 2006 reflects 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. The change in net sales for the six months ended June 30, 2006 also
reflects an approximate 1% increase in prescriptions compared to the prior year period while
prescriptions for the three months ended June 30, 2006 experienced a 3% decrease compared to the
three months ended June 30, 2005. Additionally, prescriptions for the three months ended June 30,
2006 were 1% lower compared to the three months ended March 31, 2006 and 4% lower compared to the
three months ended December 31, 2005. These trends reflect a continuing decrease in prescriptions
under Medicaid contracts as marginal Medicaid contracts are terminated, partially offset by
increases in prescriptions under managed care contracts and Medicare Part D. The increase in
AVINZA net sales for the three and six months ended June 30, 2006, further reflects a reduction in
Medicaid rebates of approximately $4.4 million and $6.9 million, respectively, partially offset by
an increase in managed care rebates of approximately $0.2 million and $1.6 million, respectively,
under contracts with pharmacy benefit manager (PBMs), group purchasing organizations (GPOs), and
health maintenance organizations (HMOs), and under Medicare Part D.
AVINZA net sales for the three and six months ended June 30, 2006 also reflect an approximate
charge of $2.1 million for losses expected to be incurred on product returns resulting from a 6%
price increase effective July 1, 2006. This compares to a charge of $3.5 million recorded for the
three months ended March 31, 2005 in connection with a 7% AVINZA price increase effective April 1,
2005. Upon an announced price increase, we revalue our estimate of deferred product revenue to be
returned to recognize the potential higher credit a wholesaler
32
may take upon product return
determined as the difference between the new price and the previous price used to value the
allowance. The decrease in the charge for the 2006 period is primarily due to lower rates of
return on lots that closed out in the first and second quarters of 2006, thereby lowering the
historical weighted average rate of return used for estimating the allowance for return losses.
AVINZA net sales for the three and six months ended June 30, 2006 also benefited from a reduction
in the existing allowance for return losses of $2.4 million and $3.0 million, respectively, due to
the lower rates of return on the lots that closed in 2006.
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 June 30, 2006 could result in adjustments to our Medicaid
and managed care contract rebate accruals and net product sales of approximately $0.3 million and
$1.0 million, respectively.
ONTAK
Sales of ONTAK were $8.2 million and $17.4 million, respectively, for the three and six months
ended June 30, 2006 compared to $8.8 million and $16.8 million for the same 2005 period. ONTAK
sales for the 2006 periods 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 three and six months ended June 30, 2006 compared to the prior year
periods were negatively impacted by 16% and 11%, respectively, decrease in wholesaler out-movement
due primarily to a decline in the office segment of the market, which was effected by negative
changes in the Centers for Medicare and Medicaid Services reimbursement rates. 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. We may continue to
experience quarter to quarter fluctuations in demand, however, as hospitals and clinics
administering ONTAK adjust to the changing reimbursement environment. For example, ONTAK demand
for the quarter ended June 30, 2006 increased 1% from the fourth quarter of 2005 but decreased 8%
from the first quarter of 2006.
Targretin capsules
Net sales of Targretin capsules were $5.0 million and $10.0 million, respectively, for the
three and six months ended June 30, 2006 compared to $4.7 million and $8.7 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 and six months ended June 30, 2006 also
benefited from a 34% and 42%, respectively, increase in unit sales in Europe compared to the prior
year periods.
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 the second half of
2006.
Collaborative Research and Development and Other Revenue
Collaborative research and development and other revenues for the three and six months ended
June 30, 2006 were $1.1 million and $4.1 million, respectively, compared to $4.1 million and $6.0
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 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.
33
A comparison of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Collaborative research and development |
|
$ |
784 |
|
|
$ |
862 |
|
|
$ |
1,678 |
|
|
$ |
1,724 |
|
Development milestones and other |
|
|
336 |
|
|
|
3,202 |
|
|
|
2,414 |
|
|
|
4,280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,120 |
|
|
$ |
4,064 |
|
|
$ |
4,092 |
|
|
$ |
6,004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development milestones and other
Development milestones for the 2006 period reflect a milestone of $2.0 million earned in the
three months ended March 31, 2006 from GlaxoSmithKline in connection with the commencement of Phase
III studies of eltrombopag and a $0.3 million milestone earned in the three months ended June 30,
2006 from Wyeth in connection with the filing of an NDA for bazedoxifene. This compares to
milestones earned in the six months ended June 30, 2005 of $3.0 million from GlaxoSmithKline and
$1.1 million from TAP.
Gross Margin
Gross margin on product sales was 78.3% for the three months ended June 30, 2006 compared to
74.4% for the same 2005 period. For the six months ended June 30, 2006, gross margin on product
sales was 79.0% compared to 71.7% for the same 2005 period. The improvement in the gross margin
percentages in 2006 is primarily attributed to the following factors which are further discussed
below:
|
|
|
Price increases; |
|
|
|
|
Lower AVINZA rebates under Medicaid; |
|
|
|
|
Lower allowance for return losses; |
|
|
|
|
Higher AVINZA net sales to cover the fixed amortization of intangible assets; |
|
|
|
|
Lower ONTAK royalty expense. |
Price Increases. Gross margin for the three and six months ended June 30, 2006 compared to
the same 2005 periods 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 a full period impact on the margins for the three and six months ended
June 30, 2005.
Rebates. The increase in the gross margin percentage for the three and six months ended June
30, 2006 reflects higher net AVINZA sales due to lower Medicaid rebates of approximately $4.4
million and $6.9 million, respectively, partially offset by an increase in managed care rebates of
approximately $0.2 million and $1.6 million, under contracts with PBMs, GPOs, and HMOs.
Allowance for Return Losses. Gross margins for the three months ended March 31, 2005 reflect
a $3.5 million reduction in sales for losses expected to be incurred on product returns resulting
from an AVINZA price increase, effective April 1, 2005. This compares to a charge of $2.1 million
in the three months ended June 30, 2006 for losses expected to be incurred on product returns
resulting from a 6% price increase effective July 1, 2006. Upon an announced price increase, we
revalue our estimate of deferred product revenue to be returned to recognize the potential higher
credit a wholesaler may take upon product return. The decrease in the charge for the 2006 period
is primarily due to lower rates of return on lots that closed out in the first and second quarters
of 2006, thereby lowering the historical weighted average rate of return used for estimating the
allowance for return losses. Additionally, AVINZA net sales for the three and six months ended
June 30, 2006 benefited from a reduction in the
34
existing allowances for return losses of $2.4
million and $3.0 million, respectively, due to the lower rates of return on lots that closed in
2006.
Higher Relative Net Sales of AVINZA. The margin for the three and six months ended June 30,
2006 compared to the prior year periods also benefited from the relative increase in sales of
AVINZA. AVINZA represented 71.1% and 69.4%, respectively, of net product sales for the three and
six months ended 2006 compared to 65.8% and 64.4%, respectively, for the same 2005 periods. 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.
Lower ONTAK Royalty Expense. 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
positively impacted during the three and six months ended June 30, 2006 by lower royalty expense as
a result of the restructuring of the Companys royalty obligation to Lilly. Although there was no
U.S. royalty owed to Lilly for the three and six months ended June 30, 2005, cost of sales for that
period reflects the recognition of deferred royalty expense of approximately $1.1 million and $2.6
million, respectively, 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 the economic benefits of the assets are consumed (or otherwise used up) cannot
be reliably determined. At June 30, 2006, acquired technology, products rights and royalty
buy-down, net totaled $139.8 million.
Overall, given the continuing impact of price increases and 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 $13.9 million and $26.1 million, respectively, for the
three and six months ended June 30, 2006 compared to $14.5 million and $29.3 million for the same
2005 periods. The major components of research and development expenses are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Research |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research performed under collaboration agreements |
|
$ |
1,044 |
|
|
$ |
1,013 |
|
|
$ |
1,968 |
|
|
$ |
1,995 |
|
Internal research programs |
|
|
5,156 |
|
|
|
5,354 |
|
|
|
9,891 |
|
|
|
10,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research |
|
|
6,200 |
|
|
|
6,367 |
|
|
|
11,859 |
|
|
|
12,326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
New product development |
|
|
5,077 |
|
|
|
5,227 |
|
|
|
9,308 |
|
|
|
11,323 |
|
Existing product support (1) |
|
|
2,618 |
|
|
|
2,930 |
|
|
|
4,946 |
|
|
|
5,610 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total development |
|
|
7,695 |
|
|
|
8,157 |
|
|
|
14,254 |
|
|
|
16,933 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
13,895 |
|
|
$ |
14,524 |
|
|
$ |
26,113 |
|
|
$ |
29,259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes costs incurred to comply with post-marketing regulatory commitments. |
35
Spending for research expenses was $6.2 million and $11.9 million, respectively, for the three
and six months ended June 30, 2006 compared to $6.4 million and $12.3 million for the same 2005
periods. The decrease in internal research program expenses for the three and six months ended June
30, 2006 compared to the same 2005 periods reflects decreased research expenses across several
research programs.
Spending for development expenses decreased to $7.7 million and $14.3 million, respectively,
for the three and six months ended June 30, 2006 compared to $8.2 million and $16.9 million for the
same 2005 periods 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. This
decrease was partially offset by an increase in LGD4665 thrombopoietin (TPO) and LGD5552
(Glucocorticoid agonist) expenses as our lead drug candidates in these areas were 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 post-marketing regulatory studies. 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.
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
|
|
Phase II/III |
|
|
NSCLC second/third line
|
|
Phase II |
|
|
Advanced breast cancer
|
|
Phase II |
|
|
Renal cell cancer
|
|
Phase II |
Targretin gel
|
|
CTCL
|
|
Marketed in U.S. |
|
|
Hand dermatitis (eczema)
|
|
Phase II |
|
|
Psoriasis
|
|
Phase II |
LGD4665 (Thrombopoietin oral mimic)
|
|
Idiopathic Thrombocytopenia
(ITP), other Thrombocytopenias
|
|
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
36
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 $24.6 million and $47.0 million, respectively,
for the three and six months ended June 30, 2006 compared to $20.1 million and $39.4 million for
the same 2005 periods. The increase is due primarily to legal costs (incurred in connection with
the ongoing SEC investigation, shareholder litigation and our strategic alternatives process) which
increased by approximately $2.7 million and $4.0 million for the three and six months ended June
30, 2006 compared to the prior year periods. In June 2006, we announced that we had reached a
settlement with the plaintiffs in the Companys shareholder litigation. The amounts to be paid to
the plaintiffs and the plaintiffs attorneys and a portion of our legal expenses incurred in
connection with the shareholder litigation are expected to be covered by proceeds provided under
our Directors and Officers (D&O) Liability insurance. Legal expenses incurred during the three
months ended June 30, 2006 that were not covered under the D&O policy amounted to approximately
$1.4 million.
General and administrative expenses were also higher for the three and six months ended June
30, 2006 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 and consultant
costs incurred in the second quarter of 2006 in connection with our 2006 SOX compliance program. 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.
In addition, AVINZA advertising and promotion expenses increased in the three and six months
ended June 30, 2006 compared to the prior year periods 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 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 periods.
We expect selling, general and administrative expenses to continue to be higher in the second
half of 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 and strategic
alternatives process and the 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 $11.1 million and $21.9 million, respectively,
for the three and six months ended June 30, 2006 compared to $7.0 million and $14.7 million for the
same 2005 periods. 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.
Co-promotion expense for the three and six months ended June 30, 2006 also includes $3.3
million and $6.6 million, respectively, which represents the pro-rata accrual of a $10.0 million
payment we agreed to make to Organon in January 2007, provided that Organon achieves 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.
37
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 for the three months ended
June 30, 2006 included a $0.4 million credit. This credit reflects a reduction in net present value
of the co-promote termination liability resulting from the updated estimate of net AVINZA product
sales as of June 30, 2006. Co-promote termination charges recorded in the three months ended March
31, 2006, represent the cost associated with the termination agreement totaling $132.9 million, and
are 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 June 30, 2006 also includes approximately $6.8 million
of accretion expense to reflect the net present value of the liability as of that date which is
included in interest expense.
Interest Expense
Interest expense was $6.2 million and $12.2 million for the three and six months ended June
30, 2006, respectively, compared to $3.0 million and $6.2 million for the same 2005 periods. A
comparison of interest expense is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Accretion of interest on co-promote
termination liability |
|
$ |
3,500 |
|
|
$ |
|
|
|
$ |
6,800 |
|
|
$ |
|
|
Interest on 6% Convertible Subordinated Notes |
|
|
1,930 |
|
|
|
2,329 |
|
|
|
3,935 |
|
|
|
4,658 |
|
Other interest |
|
|
726 |
|
|
|
701 |
|
|
|
1,488 |
|
|
|
1,499 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
6,156 |
|
|
$ |
3,030 |
|
|
$ |
12,223 |
|
|
$ |
6,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The interest expense on the co-promote termination liability reflects the accretion to the
current net present value of the liability recorded in connection with the termination of the
co-promote agreement with Organon as further discussed under Recent Developments. The lower
interest expense on the 6% Convertible Subordinated Notes is due to the conversion of a portion of
such notes during the six months ended June 30, 2006 also discussed further under Recent
Developments.
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 $154.5 million at June 30, 2006 compared to a deficit of
$102.2 million at December 31, 2005. Cash, cash equivalents, short-term investments and restricted
investments totaled $62.6 million at June 30, 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.
Operating Activities
Operating activities used cash of $26.4 million for the six months ended June 30, 2006
compared to $10.5 million for the same 2005 period. The use of cash for the six months ended June
30, 2006 reflects a higher net loss including the effect of a higher adjustment for non-cash
operating expenses for the 2006 period. Non-cash operating expense in 2006 includes the
recognition of $2.0 million of stock compensation expense in connection with the adoption of
SFAS123(R) and option grants to non-employees. The higher use of cash for the 2006 period is
further impacted by changes in operating assets and liabilities due to decreases in deferred
revenues net of
38
$14.5 million and increases in current assets of $10.2 million, partially offset by
decreases in inventories, net of $1.5 million, increases in accounts payable and accrued
liabilities of $2.9 million, and accounts receivable, net of $2.3 million. As further discussed
below, the reconciliation of net loss to net cash used in operating activities for the six months
ended June 30, 2006 compared to the prior year period also reflects the accrual of the AVINZA
co-promote termination liability due Organon of $139.3 million in connection with the termination
and return of rights agreement entered into in January 2006.
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).
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 $9.8 million and
the decrease in other current assets of $4.8 million partially offset by an increase in
inventories, net of $3.3 million and a decrease in accounts payable and accrued liabilities of $4.1
million.
Investing Activities
Investing activities provided cash of $0.9 million for the six months ended June 30, 2006
compared to the use of cash of $49.9 million for the same 2005 period. Cash provided for the six
months ended June 30, 2006 primarily reflects proceeds of $1.5 million for the sales of short-term
investments net of purchases of short-term investments, partially offset by purchases of property
and equipment of $0.7 million. The use of cash for the six months ended June 30, 2005 reflects a
$33.0 million 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, $15.2 million of net
purchases of short-term investments, $1.1 million of purchases of property and equipment, and a
$0.5 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 $0.4 million for the six months ended June 30, 2006
compared to $0.7 million for the same 2005 period. Cash provided by financing activities for the
six months ended June 30, 2006 includes proceeds from the exercise of employee stock options of
$1.5 million partially offset by net payments under equipment financing arrangements of $0.8
million and the repayment of long-term debt of $0.2 million. Cash provided by financing activities
for the six months ended June 30, 2005 includes proceeds from the exercise of employee stock
options of $0.9 million, partially offset by repayment of long-term debt of $0.2 million.
Certain of our property and equipment is pledged as collateral under various equipment
financing arrangements. As of June 30, 2006, $5.0 million was outstanding under such arrangements
with $2.1 million classified as current. Our equipment financing arrangements have terms of three
to four years with interest ranging from 4.73% to 10.11%.
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 and sale-leaseback transactions for certain
assets.
39
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 June 30, 2006, we are not involved in any off-balance sheet arrangements.
Contractual Obligations
As of June 30, 2006, future minimum payments due under our contractual obligations are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
Total |
|
|
Less than 1 year |
|
|
1-3 years |
|
|
3-5 years |
|
|
After 5 years |
|
Capital lease obligations (1) |
|
$ |
5,553 |
|
|
$ |
2,483 |
|
|
$ |
2,942 |
|
|
$ |
128 |
|
|
$ |
¾ |
|
Operating lease obligations |
|
|
19,732 |
|
|
|
2,989 |
|
|
|
4,162 |
|
|
|
3,890 |
|
|
|
8,691 |
|
Loan payable to bank (2) |
|
|
13,405 |
|
|
|
1,191 |
|
|
|
12,214 |
|
|
|
¾ |
|
|
|
¾ |
|
6% Convertible Subordinated Notes (3) |
|
|
138,957 |
|
|
|
7,689 |
|
|
|
131,268 |
|
|
|
¾ |
|
|
|
¾ |
|
Organon termination liability (4)(5) |
|
|
271,374 |
|
|
|
45,881 |
|
|
|
28,948 |
|
|
|
40,164 |
|
|
|
156,381 |
|
Other liabilities (6) |
|
|
584 |
|
|
|
105 |
|
|
|
211 |
|
|
|
211 |
|
|
|
57 |
|
Retention bonus obligation |
|
|
2,643 |
|
|
|
2,643 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
Distribution service agreements |
|
|
12,520 |
|
|
|
10,016 |
|
|
|
2,504 |
|
|
|
¾ |
|
|
|
¾ |
|
Consulting agreements |
|
|
972 |
|
|
|
972 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
Manufacturing agreements |
|
|
8,859 |
|
|
|
8,859 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
474,599 |
|
|
$ |
82,828 |
|
|
$ |
182,249 |
|
|
$ |
44,393 |
|
|
$ |
165,129 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes interest payments as follows |
|
$ |
556 |
|
|
$ |
337 |
|
|
$ |
215 |
|
|
$ |
4 |
|
|
$ |
¾ |
|
|
(2) Includes interest payments as follows |
|
|
1,735 |
|
|
|
834 |
|
|
|
901 |
|
|
|
¾ |
|
|
|
¾ |
|
|
(3) Includes interest payments as follows |
|
|
10,807 |
|
|
|
7,689 |
|
|
|
3,118 |
|
|
|
¾ |
|
|
|
¾ |
|
|
(4) Includes accretion of interest as
follows |
|
|
132,036 |
|
|
|
940 |
|
|
|
7,869 |
|
|
|
17,705 |
|
|
|
105,522 |
|
|
(5) Includes $37,750 payment due Organon on or before October 15, 2006. |
|
|
|
|
|
|
|
|
|
|
|
|
|
(6) Includes a liability under a royalty financing agreement. |
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 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 $15.3 million. For the 12 months ended December 31, 2006, we plan
to spend approximately $2.4 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.
In March 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
$2.6 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
40
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 and six months ended June 30,
2006, the Company recognized approximately $0.8 million and $1.1 million, respectively, 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.
On June 29, 2006, we announced that we reached agreement to settle the securities class action
litigation filed in the United States District Court for the Southern District of California
against us and certain of our directors and officers. In addition, we also reached agreement to
settle the shareholder derivative actions filed on behalf of the Company in the Superior Court of
California and the United States District Court for the Southern District of California.
The settlements, which are subject to court approval, resolve all claims by the parties,
including those asserted against Ligand and the individual defendants in these cases. Under the
agreements, we will pay a total of $12.2 million in cash in full settlement of all claims. The
$12.2 million settlement amount and a portion of our total legal expenses will be funded by our
Directors and Officers Liability insurance carrier while the remainder of the legal fees incurred
($1.4 million for the three months ended June 30, 2006) will be paid by us. Of the $12.2 million
settlement liability, $4.2 million will be paid to us directly from the insurance carrier and then
disbursed to the claimants attorneys while the remaining $8.0 million will be paid by the
insurance carrier directly to an independent escrow agent responsible for disbursing the funds to
the class action suit claimants. Accordingly, we have recorded $12.2 million as an accrued
liability with a corresponding receivable from our insurance carrier on our balance sheet as of
June 30, 2006. In July 2006, our insurance carrier funded the escrow account with the $8.0 million
to be disbursed to the claimants. Under SFAS No. 140, Accounting for Transfers and Servicing of
Financial Assets and Extinguishments of Liabilities, funding of the escrow account represents the
extinguishment of our liability to the claimants. Accordingly, we will derecognize the $8.0
million receivable and accrued liability in our consolidated financial statements as of September
30, 2006. As part of the settlement of the state derivative action, we have agreed to adopt
certain corporate governance enhancements including the formalization of certain Board practices
and responsibilities, a Board self-evaluation process, Board and Board Committee term limits (with
gradual phase-in) and one-time enhanced independent requirements for a single director to succeed
the current shareholder representatives on the Board. Neither we nor any of our current or former
directors and officers have made any admission of liability or wrongdoing. The related
investigation by the Securities and Exchange Commission is ongoing and is not affected by the
settlements discussed above.
On July 31, 2006, we entered into a separation agreement with David Robinson providing for Mr.
Robinsons resignation as Chairman, President, and Chief Executive Officer of the Company. Under
the separation agreement, Mr. Robinson will receive his base salary and certain benefits for 24
months, payable in five equal monthly installments beginning August 1, 2006 and ending December 1,
2006. In addition, the agreement provides for the immediate vesting of Mr. Robinsons unvested
stock options and an extension of the exercise period of his options to January 15, 2007. In
connection with the resignation, we will recognize an expense of approximately $2.1 million in our
third quarter 2006 financial statements, comprised of cash payments of $1.4 million and stock based
compensation of $0.7 million associated with the modification of the vesting and exercise period of
the stock options.
41
On August 1, 2006, we announced that current director Henry F. Blissenbach had been named
Chairman and interim Chief Executive Officer. We have agreed to pay Dr. Blissenbach $75,000 per
month, commencing August 1, 2006, subject to cancellation by either party on thirty days notice,
for his services as Chairman and interim Chief Executive Officer. In addition, Dr. Blissenbach
will be eligible to receive incentive compensation of up to 50% of his base salary, but not more
than $150,000, based upon his performance of certain objectives to be agreed upon and incorporated
into an employment agreement which we and Dr. Blissenbach will enter into. Also, Dr. Blissenbach
received a special stock option grant to purchase 150,000 shares of our common stock at an exercise
price equal to the closing price of our common stock on August 3, 2006 as reported on The NASDAQ
Global Market. These stock options will vest 50% at the end of six months and the remaining 50%
will vest at the end of one year, except that all of these stock options will vest upon the
appointment of a new Chief Executive Officer. Finally, we will reimburse Dr. Blissenbach for all
reasonable expenses incurred in discharging his duties as interim Chief Executive Officer,
including, but not limited to commuting costs to San Diego and living and related costs during the
time he spends in San Diego.
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 six months ended June 30, 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
($101.6 million as of June 30, 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 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),
42
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 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-and six
months ended June 30, 2006, we recorded $1.2 million and $2.0 million, respectively, 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 APB
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 June 30, 2006, our investment portfolio included fixed-income securities of $19.8 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 June 30, 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.
43
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 June 30, 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 June 30, 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 June 30, 2006, certain of 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 June 30, 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. Although changes have
been implemented to our internal controls over financial reporting to address certain of these
matters, as further discussed in Item (b) below, management has not completed their own assessment
of these control deficiencies and their impact on our internal control over financial reporting.
|
|
|
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 Corporate Accounting, a Senior Accounting Manager and a Director of
Internal Audit in the second quarter of 2006. The Company has also staffed the position of
Senior Revenue Recognition Analyst through an internal transfer in the second quarter of
2006 and hired a senior internal auditor and internal audit staff member in the third
quarter of 2006. Additionally, the Company has hired a Director of Budget and Financial
Analysis in August 2006 to replace the Senior Manager, Budget and Financial Analysis who
left the Company in June 2006. The Company is still in the process of recruiting for a
Manager of Revenue Recognition. While management believes that it has appropriately
designed the organization structure of its accounting and finance
department and has made significant progress in staffing key positions, the Company is not yet in a position to conclude that this
weakness has been fully remediated. |
|
|
|
|
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 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 June 30, 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 (and considering that the remediation efforts
described above in qualified accounting personnel were not completed until the second and
third quarters of 2006) resulted in managements inability to conclude that such controls
were operating effectively for a reasonable period of time prior to June 30, 2006. |
|
|
|
|
Internal Audit. The Company did not maintain an independent effective Internal Audit
department. This material weakness resulted from: 1) the Internal Audit department being
redirected during the second, third |
44
|
|
|
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 Director of Internal Audit who commenced employment in the second
quarter of 2006 and hired a senior internal auditor and an internal audit staff member in
the third quarter of 2006. The Companys internal audit plan for 2006 was approved by the
Companys Audit Committee in the third 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. The Company did not
have, however, effective end user general controls over the access, change management and
validation of spreadsheets used in its financial processes, nor did the Company have formal
policies and procedures in place relating to the use of spreadsheets. As more fully
discussed below, management has commenced the implementation of 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 include controls relating
to data integrity, version control, and restricted access to such spreadsheets, were
implemented and are considered to be operating effectively for the Companys key revenue
recognition spreadsheets as of June 30, 2006 and are expected to be fully implemented for
all key spreadsheets in the third quarter of 2006. Considering the significant reliance on
spreadsheets in the current period and given that the implementation of the policies and
procedures described above are still in process as of June 30, 2006, the continuing
deficiencies discussed above surrounding the use of spreadsheets have been assessed to be a
material weakness as of June 30, 2006. |
|
|
|
|
Segregation of Duties. Management identified certain members of the Companys
accounting and finance department who had 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. In the first and second quarters of 2006, the Company terminated access rights for
those individuals who were determined to have system access incompatible with their job
functions. While management believes the controls with respect to segregation of duties
were appropriately designed and effective at June 30, 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 managements inability to conclude that such controls were operating effectively for a
reasonable period of time prior to June 30, 2006. |
|
|
|
|
Monitoring Controls. As a result of the demands placed on the Companys accounting and
finance department with respect to the Companys accounting restatement in 2005, 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 this control deficiency
constituted a material weakness as of December 31, 2005. As discussed below, management has
implemented procedures to ensure more timely maintenance of internal control documentation
and execution of its monitoring controls over its internal controls over financial
reporting. However, such procedures were not fully implemented until the second quarter
2006 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
June 30, 2006. |
45
As of June 30, 2006, certain of the material weaknesses identified in the 2005 Form 10-K, as
listed below, have been assessed, as further discussed in Item (b) below, by management to be fully
remediated. BDO Seidman LLP, our independent registered public accountants, has not performed any
procedures to review our remediation efforts.
|
|
|
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.
Management believes the controls with respect to revenue recognition were appropriately
designed and effective at June 30, 2006, as further discussed in Item (b) below. |
|
|
|
|
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. Management believes the controls with respect to record
keeping were appropriately designed and effective at June 30, 2006, as further discussed in
Item (b) below. |
b) Remediation Steps to Address Material Weaknesses
Revenue Recognition
|
|
|
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 has been developed and took place during the fourth quarter of 2005. In 2006,
additional training will be provided and updated as considered necessary. |
|
|
|
|
The Company has staffed the position of Senior Revenue Recognition Analyst in the second
quarter of 2006 and has implemented additional reviews over the revenue recognition area by
senior accounting and finance personnel. While management continues to recruit for a
Manager of Revenue Recognition, it believes that the measures identified above are
sufficient to address the control considerations surrounding revenue recognition. |
|
|
|
|
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. Management believes the controls with respect to revenue recognition were
appropriately designed and effective at June 30, 2006. |
46
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. |
|
|
|
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. Management believes the controls with respect to record keeping and documentation
were appropriately designed and effective at June 30, 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 was hired. During the second
quarter of 2006, the Company hired a Director of Internal Audit, who is a certified public
accountant and who commenced 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. |
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The Company hired additional senior accounting personnel who are certified public
accountants including, as discussed above, a Director of Corporate Accounting, a Director
of Internal Audit and a Senior Accounting Manager. The Company has also staffed the
position of Senior Revenue Recognition Analyst through an internal transfer in the second
quarter of 2006 and hired a senior internal auditor and internal audit staff member in the
third quarter of 2006. Additionally, the Company has hired a Director of Budget and
Financial Analysis in August 2006 to replace the Senior Manager, Budget and Financial
Analysis who left the Company in June 2006. |
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While management believes that it has appropriately designed the organization structure
of its finance department and has made significant progress in
staffing key positions, the Company is not yet in a
position to conclude that this weakness has been fully remediated. |
Financial Statement Close Procedures
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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 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 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. |
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The remediation efforts described above were not implemented until the fourth quarter of
2005 (and the remediation efforts described above in qualified accounting personnel was not
substantially completed until the second and third quarters of 2006), 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 June 30, 2006. |
Internal Audit
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As discussed under the caption Lack of Sufficient Qualified Accounting Personnel above,
the Company hired a Director of Internal Audit, who commenced employment in the second
quarter of 2006 and hired a senior internal auditor and internal audit staff member in the
third quarter of 2006. Until the Director of Internal Audit commenced employment, the
Company engaged a nationally recognized external consulting firm to perform the functions
of the Internal Audit department. The internal audit plan for 2006 was approved by the
Companys Audit Committee in the third quarter of 2006. |
Spreadsheet Controls
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Revenue Spreadsheet 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. As of June 30, 2006,
the Company believes that the controls surrounding the revenue spreadsheets were
appropriately designed and effective. |
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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. After being inventoried, the
spreadsheets are 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 are addressed.
Management has commenced the implementation of 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 include controls relating to data integrity, version
control, and restricted access to such spreadsheets, are expected to be fully implemented
in the third quarter of 2006. |
Segregation of Duties
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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 monitors 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. |
Monitoring Controls
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As discussed under the caption Internal Audit above, the Company hired a Director of
Internal Audit, who commenced employment in the second quarter of 2006. Additionally,
prior to the Director of Internal Audit commencing employment, the Company engaged and
continues to use a nationally recognized external consulting firm to assist with internal
audit services. As part of this service, 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. |
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Independent Registered Public Accountants
BDO Seidman LLP, our independent registered public accountants, has 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 June 30, 2006 that have materially
affected, or are reasonably likely to materially affect, the Companys internal control over
financial reporting.
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PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Securities Litigation
Since August 2004, the Company has been involved in several securities class action and
shareholder derivative actions which followed announcements by the Company in 2004 and the
subsequent restatement of its financial results in 2005. In June 2006, we announced that these
lawsuits had been settled, subject to certain conditions such as court approval.
Background
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.
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 were in
the discovery phase.
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., 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.
The Settlement Agreements
The Company has entered into agreements to resolve all claims by the parties in each of these
matters, including those asserted against the Company and the individual defendants in these cases.
Under the agreements, we will pay a total of $12.2 million in cash in full settlement of all
claims. The $12.2 million settlement amount and a portion of our total legal expenses will be
funded by our Directors and Officers Liability insurance carrier while the remainder of the legal
fees incurred ($1.4 million for the three months ended June 30, 2006) will be paid by us. Of the
$12.2 million settlement liability, $4.2 million will be paid to us directly from the insurance
carrier and then disbursed to the claimants attorneys while the remaining $8.0 million will be
paid by the insurance carrier directly to an independent escrow agent responsible for disbursing
the funds to the class action suit claimants. Accordingly, we have recorded $12.2 million as an
accrued liability with a corresponding receivable from our insurance carrier on our balance sheet
as of June 30, 2006. In July 2006, our insurance carrier funded the escrow account with the $8.0
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million to be disbursed to the claimants. Under SFAS No. 140, Accounting for Transfers and
Servicing of Financial Assets and Extinguishments of Liabilities, funding of the escrow account
represents the extinguishment of our liability to the claimants. Accordingly, we will derecognize
the $8.0 million receivable and accrued liability in our consolidated financial statements as of
September 30, 2006. As part of the settlement of the state derivative action, we have agreed to
adopt certain corporate governance enhancements including the formalization of certain Board
practices and responsibilities, a Board self-evaluation process, Board and Board Committee term
limits (with gradual phase-in) and one-time enhanced independent requirements for a single director
to succeed the current shareholder representatives on the Board. Neither we nor any of our current
or former directors and officers have made any admission of liability or wrongdoing. The United
States District Court has preliminarily approved the settlement of the class action, however, that
settlement and the settlement of the derivative actions are all subject to final approval by the
courts in which they are pending.
SEC Investigation and Other Matters
In connection with the restatement of the Companys consolidated financial statements, the SEC
instituted a formal investigation concerning the consolidated financial statements. These matters
were previously the subject of an informal SEC inquiry. Ligand has been cooperating fully with the
SEC and will continue to do so in order to bring the investigation to a conclusion as promptly as
possible.
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 June 30, 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.
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.
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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 and the increased possibility of legal or administrative proceedings.
We determined that our consolidated financial statements for the years ended December 31, 2002
and 2003, and 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:
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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. |
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We were 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. While we have
agreed to settle this litigation, the settlements are subject to
court approval. If not approved we could face substantial
additional legal fees or judgments in excess of our insurance
policy limits and management distraction. |
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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. |
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 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 June 30, 2006.
Because we have concluded that our internal control over financial reporting is not effective
as of June 30, 2006 and our independent registered public accounting firm 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, we could be delisted from the NASDAQ Global Market, our ability to obtain additional
financing, or
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obtain additional financing on favorable terms, could be materially and adversely
affected, each of 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 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 delisting from
the NASDAQ Global Market.
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.
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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 ($101.6 million as of June 30, 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 (including for events, circumstances, changes in trends, and/or strategic decisions
taken with respect to the product) 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 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 mean 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
54
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 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 June 30,
2006, our accumulated deficit was approximately $989.2 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; |
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the products, once approved, may not achieve commercial acceptance; |
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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.
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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.
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.
Our revenues are dependent on maintaining an effective marketing and sales capability in the United
States and Europe which is expensive and time-consuming and may increase our operating losses.
Maintaining an effective sales force to market and sell products is difficult, expensive and
time-consuming. We have developed a US sales force of approximately 119 people as of June 30, 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
56
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:
|
Ø |
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conduct research, preclinical testing and human studies; |
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establish pilot scale and commercial scale manufacturing processes and facilities; and |
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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:
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the pace of scientific progress in our research and development programs and the
magnitude of these programs; |
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the scope and results of preclinical testing and human studies; |
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the time and costs involved in obtaining regulatory approvals; |
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the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
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competing technological and market developments; |
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our ability to establish additional collaborations; |
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changes in our existing collaborations; |
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the cost of manufacturing scale-up; and |
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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, possible sale of assets or other
transactions resulting from our strategic alternatives evaluation process which is ongoing, 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.
57
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 six months ended June 30, 2006, holders of notes with a
face value of $27.1 million (approximately 17% of total outstanding notes) converted their notes
into approximately 4.4 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-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
58
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 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.
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.
59
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.
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
60
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.
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, manufactures the Targretin active pharmaceutical
ingredient, and Cardinal Health manufactures Targretin capsules for us. Raylo was recently
acquired by a third party and gave us notice in June 2006 that our contract with it will terminate
in two years. We will need to replace this manufacturing capability in time to ensure
uninterrupted supply of Targretin to the market. If we are unable to timely identify and contract
with another manufacturer, or if such manufacturer is delayed in receiving regulatory approval or
beginning a successful manufacturing program, our sales of Targretin could be harmed.
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 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
61
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.
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.
62
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On April 17, 2006, an aggregate of approximately 3,125 shares of our common stock was issued
to a former employee of the Company in connection with an option exercise under the Companys 2002
stock option plan. We received approximately $31,100 from the option exercise. The issuance of
shares of Company common stock to such individual was exempt under Section 4(2) and/or 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 six months ended June 30, 2006, convertible notes with a face value of $27.1
million were converted into approximately 4.4 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.
63
ITEM 6. EXHIBITS
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Exhibit Number |
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Description |
3.1 (1)
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Amended and Restated Certificate of Incorporation of the Company. (Filed as Exhibit 3.2). |
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3.2 (1)
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Bylaws of the Company, as amended. (Filed as Exhibit 3.3). |
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3.3 (2)
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Amended Certificate of Designation of Rights, Preferences and Privileges of Series A Participating Preferred Stock of the Company. |
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3.5 (3)
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Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Company dated June 14, 2000. |
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3.6 (4)
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Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the Company dated September 30, 2004. |
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3.7 (5)
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Amendment to the Bylaws dated November 13, 2005 (Filed as Exhibit 3.1). |
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4.1 (6)
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Specimen stock certificate for shares of Common Stock of the Company. |
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4.2 (7)
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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). |
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4.3 (8)
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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). |
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4.4 (9)
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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). |
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4.7 (10)
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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. |
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4.9 (11)
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Indenture dated November 26, 2002, between Ligand Pharmaceuticals Incorporated and J.P. Morgan Trust Company, National Association, as trustee, with respect to the 6% convertible subordinated notes due 2007. (Filed as Exhibit 4.3). |
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4.10 (11)
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Form of 6% Convertible Subordinated Note due 2007. (Filed as Exhibit 4.4). |
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4.11 (11)
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Pledge Agreement dated November 26, 2002, between Ligand Pharmaceuticals Incorporated and J.P. Morgan Trust Company, National Association. (Filed as Exhibit 4.5). |
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4.12 (11)
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Control Agreement dated November 26, 2002, among Ligand Pharmaceuticals Incorporated, J.P. Morgan Trust Company, National Association and JP Morgan Chase Bank. (Filed as Exhibit 4.6). |
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4.13 (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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10.293
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First Amendment to the Manufacturing and Packaging Agreement between Cardinal Health PTS, LLC and Ligand Pharmaceuticals Incorporated (with certain confidential portions omitted). |
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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. |
64
|
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Exhibit Number |
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Description |
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. |
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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) |
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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) |
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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) |
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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. |
|
(6) |
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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) |
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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-3 (No. 333-12603)
filed on September 25, 1996, as amended. |
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(8) |
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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 Registration Statement on Form 8-A/A Amendment No. 1 (No.
0-20720) filed on November 10, 1998. |
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(9) |
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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 Registration Statement on Form 8-A/A Amendment No. 2 (No.
0-20720) filed on December 24, 1998. |
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(10) |
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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. |
|
(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. |
|
(12) |
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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 Form 8-A 12G/A, filed on April 6, 2004. |
65
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: August 9, 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 |
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66